Harrow Health, Inc. Aktie

Good morning, and welcome to Harrow's Second Quarter 2026 Earnings Conference Call. My name is Michelle, and I will be the operator for today's call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to Mike Biega, Vice President of Investor Relations and Communications for Harrow. Please go ahead.

Thank you, operator. Good morning, and welcome to Harrow's Second Quarter 2026 Earnings Conference Call. My name is Mike Biega, Vice President of Investor Relations and Communications, and I'm excited to be introducing today's call. The company's remarks may include forward-looking statements within the meaning of federal securities laws.

Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond Harrow's control, including risks and uncertainties described from time to time in its SEC filings, such as the risks and uncertainties related to the company's ability to make commercially available its FDA-approved products and compounded formulations and technologies, and FDA approval of certain drug candidates in a timely manner or at all. For a list and description of those risks and uncertainties, please see the risk factors section of the company's most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission.

Harrow's results may differ materially from those projected. Harrow disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of today.

Additionally, Harrow will refer to non-GAAP financial metrics, specifically adjusted EBITDA. A reconciliation of any non-GAAP measures with the most directly comparable GAAP measures is included in the company's earnings release and letter to stockholders, both of which are available on the website.

Joining me on today's call are Mark L. Baum, Chief Executive Officer; Andrew Boll, President and Chief Financial Officer; Patrick Sullivan, Chief Commercial Officer; and Amir Shojaei, Chief Scientific Officer. With that, I would like to turn the call over to Mark. Mark?

Thank you, Mike, and good morning, everyone. We spent the first half of 2026 building demand and strengthening the commercial foundation of our business. The second half is about converting that demand into accelerating revenue and growth and profitability and, of course, hitting numbers. Let me be direct. First half revenue of approximately $115 million was lighter than we expected entering the year, primarily because of the VEVYE net revenue impact we discussed last quarter.

At the same time, we executed on major operating priorities we established for the first half, expanding our commercial organization, improving the economics of key products, strengthening our portfolio, launching BYOOVIZ, and building physician demand across our key growth drivers. Those actions have positioned us to deliver meaningfully stronger revenue and growth and profitability during the second half of 2026. And IHEEZO is a good example.

Despite the loss of pass-through on April 1 of this year, IHEEZO generated the highest quarterly unit demand in its history and delivered record new account growth. Channel inventory has now normalized, and an approximately 25% improvement in net pricing became effective July 1 with gross margins exceeding 90%. We expect IHEEZO will be a major contributor to both revenue growth and profitability during the second half. VEVYE is also positioned for stronger growth. During the second quarter, prescriptions increased 21% sequentially. Our prescriber base grew 15%, and the product delivered record quarterly revenue.

The business rule changes we implemented at the end of April worked as intended. VEVYE's economics improved sequentially with meaningfully lower co-pay card utilization, which drove a higher ASP. Those results validated our ability to improve the economics of the franchise while continuing to grow prescription demand and physician adoption. During the second half, VEVYE will benefit from the full period impact of those revised business rules, broader commercial coverage that became effective August 1, an expanded sampling program, and a sales organization that has doubled in size over the past year.

Together, those factors position VEVYE for stronger prescription growth and improved net revenue realization. TRIESENCE also reached another quarterly demand record with more than half of unit demand now coming from ocular surgery. We tripled our surgical commercial organization during the second quarter, and those representatives remain early in their productivity ramp. As they broaden account coverage and deepen utilization, we expect TRIESENCE revenue growth to build throughout the second half.

BYOOVIZ represents another incremental growth driver that we launched on July 1 with encouraging early reception. And our specialty portfolio is similarly positioned to contribute more meaningfully. VERKAZIA has been relaunched, and interest is growing in the form of rising prescription volumes. And IOPIDINE now benefits from a permanent J-code. We also expanded our [ AccessPlus ] commercial organization. Each of these initiatives was either absent or only partially reflected in our first half results.

Finally, subject to closing, TYRVAYA will further strengthen our dry eye franchise. We are acquiring global rights to the product, which is approved in the United States and China and is under regulatory review in five additional countries. TYRVAYA also offers a distinctive tolerability profile, 0 contraindications, 0 ocular adverse events, and 0 warnings on its label, with sneezing as its most common adverse reaction. From a strategic perspective and given our commitment to relentlessly compete and win in the U.S. dry eye market, this acquisition makes a ton of sense.

And I would encourage stockholders to check out slide 15 in our updated corporate deck on that subject. From an acquisition cost perspective also, this deal may be the best deal we've ever struck. From sales and marketing to market access to share of voice in the ophthalmologist and the optometrist's office, we're a much stronger company with TYRVAYA in our bag. In the past, I always wondered why people would be interested in a nasal spray for their dry eye disease. But after going through our due diligence process and speaking to committed prescribers, I finally get it.

There is a very sizable patient base who benefits from this unique product, even down to the side effect profile. I had one fantastic dry eye specialist tell me that his patients just love TYRVAYA and would much rather have someone say, "God bless you," after a sneeze than to endure the stinging and burning or dysgeusia after applying eye drops multiple times a day.

Financially, while we expect only a modest revenue contribution this year based on the anticipated timing of the transaction, TYRVAYA and its experienced commercial organization will expand our reach and create additional opportunities to grow the entire dry eye franchise. In sum taken together, our principal growth drivers enter the second half with stronger demand, improved economics, broader access, and greater commercial support.

And breadth matters. Our outlook is not dependent on one product, one launch, or one reimbursement event. We have multiple commercial growth drivers positioned to contribute more meaningfully during the second half. That is why we are reiterating our full year guidance. We recognize the magnitude of the second half ramp, and Andrew will walk through the financial bridge in more detail.

We expect revenue to grow sequentially in both the third and fourth quarters with the larger step-up occurring in the fourth quarter as these initiatives contribute more fully. The first half was about doing the work required to create the opportunity in front of us. The second half is about execution. Converting that opportunity into revenue, earnings, and durable value for our stockholders. Before I turn it over to Andrew, I did want to share something that has only deepened my conviction about G-MELT.

At this year's American Society of Retina Specialists meeting, I spoke with dozens of retina specialists, and one theme came up again and again. Practices are struggling to secure reliable anesthesia coverage for their procedures. And many are now paying what they call stipends out of their own facility and global surgical fees just to keep anesthesia services available. We do not believe this is a short-term dislocation.

We believe it is a reality that eye surgeons and physicians and other specialties will be managing for many years to come. G-MELT, if approved, could be part of the solution to this growing problem. In nearly 15 years of running this company, I've never seen as consistently positive a reaction to a Harrow product candidate. And that has got me extremely excited about the future of G-MELT. With that, I'll turn the call over to Andrew.

Thank you, Mark, and good morning, everyone. We reported a revenue of $70.7 million, up 11% year-over-year and approximately 60% sequentially. That brings first half revenue to approximately $115 million. The year-over-year comparison understates the underlying trajectory. First half results reflected limited IHEEZO revenue as channel inventory normalized, as well as only a partial quarter benefit from the VEVYE business rule changes.

VEVYE delivered quarterly revenue of $29.4 million, up nearly 58% year-over-year. The result reflected continued prescription growth and improved net revenue realization following the business rule changes implemented at the end of April. IHEEZO generated $15.6 million of revenue, primarily related to wholesaler stocking orders of our new 5-pack presentation. Unit demand for IHEEZO reached a quarterly record, but reported revenue continued to lag underlying demand as distributors sold through previously purchased inventory.

We expect IHEEZO to enter the third quarter with a normalized revenue cycle and improved economics. Our specialty portfolio and TRIESENCE generated approximately $11 million of revenue, while our compounded portfolio generated $14.6 million of revenue. GAAP gross margin was 71%. For the second half, we expect gross margins to trend back towards the high 70s supported by IHEEZO's return to a normal revenue cycle, increased overall revenue, continued VEVYE growth, and more favorable product mix.

SG&A was $53.3 million, which increased quarter-over-quarter, largely reflecting the commercial investments made during the quarter. Excluding the additional headcount expected to be added through the TYRVAYA transaction at closing, we expect base SG&A dollars to remain approximately flat with second quarter levels for the balance of the year.

The core operating cost structure is largely in place, and our objective is to grow revenue against that expense base. Adjusted EBITDA was negative $1.2 million. We ended the quarter with cash and cash equivalents of $83.9 million. With the TYRVAYA transaction, we expect to fund the upfront consideration of $30 million with cash on hand. And following closing, to the extent any of the contingent net sales milestones are hit, we expect the payment of those milestone amounts will essentially be self-funded.

Turning now to our outlook, we are reiterating full year guidance of $350 million to $365 million in revenue and $80 million to $100 million in adjusted EBITDA. Based on first half revenue of approximately $115 million, our guidance implies second half revenue of approximately $235 million to $250 million. We're not providing quarterly guidance, but we expect revenue to grow sequentially in both the third and fourth quarters, with the larger step-up occurring in the fourth quarter.

That is a substantial step-up. So let me be specific about the bridge. The largest incremental contributor should be IHEEZO. We enter the second half with record demand, normalized channel inventory, and an improvement in net pricing. Those factors should allow reported revenue to more closely reflect the strength of the underlying business beginning in the third quarter.

VEVYE is another major driver. Its expanded sales organization should begin to contribute in the third quarter. The revised business rules will be in effect for the full second half of the year. Expanded commercial coverage became effective August 1, and net revenue realization should benefit as more patients satisfy their annual deductibles. TRIESENCE should also continue to grow. Demand reached another quarterly record, and the surgical organization we tripled during the second quarter remains early in its productivity curve.

BYOOVIZ formally launched July 1 following modest initial stocking activity in the second quarter. VERKAZIA has been relaunched, and now IOPIDINE benefits from a permanent J-code. Each contributes against a first half revenue base that was either minimal or constrained. Subject to closing, TYRVAYA should also contribute modest revenue this year in addition to revenue synergies with VEVYE that we expect to be realized following the close.

Our guidance assumes only a limited 2026 contribution given the anticipated timing of the close and integration. The adjusted EBITDA bridge follows directly from the revenue bridge, substantially higher revenue, increasing gross margins into the high 70s, and a base operating expense structure that remains approximately flat. Upon closing the TYRVAYA transaction, we expect to expand our dry eye sales force and territories further by adding experienced professionals from the Viatris Eye Care Division, increasing SG&A expenses by approximately $20 million on an annualized basis once fully integrated.

Looking ahead, we expect TYRVAYA to contribute more than $30 million in revenue during 2027 and overall to be financially accretive. We recognize the magnitude of the second half ramp. Our confidence is based on factors already visible in the business. Prescription growth, record product demand, normalized inventory, improved pricing, broader coverage, and a growing commercial organization that remains early in its productivity curve.

On that note, I'll now ask Pat to discuss our commercial progress in more detail.

Thank you, Andrew. Before turning to VEVYE, I'll briefly discuss what the pending TYRVAYA transaction means for our dry eye franchise. VEVYE remains the cornerstone of that franchise. TYRVAYA is complementary, offering physicians a differentiated, drop-free option for patients who may struggle with eye drops, prefer another route of administration, or are among the 45 million Americans who wear contact lenses.

Subject to closing, we expect to add a large number of experienced dry eye sales representatives from Viatris whose territories are largely complementary to our existing coverage. This will expand our geographic reach, increase the frequency of our engagement with eye care professionals, and give our team more touch points through a broader portfolio. We expect to integrate those representatives during the fourth quarter and have them supporting both VEVYE and TYRVAYA.

Together, the products give us more treatment options, greater commercial reach, and additional opportunities to grow the entire portfolio.

Turning to VEVYE, total prescriptions grew 21% sequentially compared with 14% growth for the broader branded dry eye market based on IQVIA data. New prescription growth grew 4% sequentially while our prescriber base expanded 15%, and VEVYE exited June with a 14.6% share of the branded dry eye market, up from 14% at the end of March and 7.8% a year ago. Those results are particularly encouraging because they were achieved while we implemented significant new business rules designed to improve the economics of the franchise.

Co-pay utilization declined meaningfully, yet physician adoption and prescription demand continued to grow. We are also still in the early stages of realizing the full potential of our expanded sales organization with broader commercial coverage through a top three pharmacy benefit manager effective August 1, an expanded sampling program now underway, and the ACTIVATE initiative encouraging clinicians to use VEVYE earlier in the treatment paradigm. We have multiple meaningful growth drivers coming online at the same time.

Together, these initiatives position VEVYE to accelerate prescription growth and expand its share of the branded dry eye market during the second half.

IHEEZO delivered one of the strongest commercial performances of the quarter. Despite the loss of pass-through reimbursement in the cataract surgery on April 1, unit demand reached a record of 65,477 units, up 44% sequentially and 34% year-over-year. We exited the quarter with 224 total ordering accounts, up 32% year-over-year, and 62 of those accounts placed their first-ever IHEEZO order during that quarter, the strongest quarter for a new account acquisition since launch.

Paired with a trailing 12-month reorder rate of approximately 85.5%, that reinforces that adoption continues to broaden following the reimbursement transition. Our focus now is on increasing utilization within existing accounts while expanding IHEEZO into additional procedures and sites of care, including the broader in-office procedure market, which adds more than 2.5 million annual procedures to our addressable opportunity. We believe those factors position the franchise for a substantially stronger second half.

Before moving to TRIESENCE, I want to briefly touch on BYOOVIZ. We formally launched the product on July 1, and while it remains early, initial physician engagement has been encouraging. BYOOVIZ is a natural fit within our retina organization, expands the options our team can bring to retina specialists, and increases the value of each customer interaction.

TRIESENCE also continued its exceptional momentum. Demand reached another quarterly record of 14,529 units, up 162% year-over-year. Total ordering accounts reached 805, a net increase of 69 over the quarter. And 54% of unit demand now comes from ocular surgery. That mix shift demonstrates that TRIESENCE is expanding beyond its historical retina base. We tripled our surgical commercial organization during the second quarter, and those representatives remain early in their productivity ramp. As they expand account coverage and drive broader adoption, we expect their contribution to begin showing up in the third quarter and build from there.

Finally, our specialty portfolio continues to build momentum. The permanent J-code for IOPIDINE became effective on July 1. VERKAZIA continues to progress following its relaunch, and we expanded our AccessPlus commercial organization to support what we believe is the broadest ophthalmic cash pay portfolio in the industry. Across each of these businesses, our focus remains the same, expanding physician access, improving reimbursement, and increasing commercial execution.

While I step back and look across this portfolio, what stands out most is the breadth of our momentum. We're seeing growth across multiple franchises, continued physician adoption, and expanded commercial reach, and the benefits of the investments we made throughout the first half of the year. I believe Harrow enters the second half of 2026 in its strongest commercial position to date. I'm excited about the opportunities ahead.

I'll turn it over to Amir to discuss some exciting developments with our R&D pipeline.

Thank you, Pat. I'll start with G-MELT or MELT-300. As I mentioned during our last quarterly webcast, we have now officially secured our pre-NDA meeting with the FDA, which is scheduled for early in the fourth quarter. We are currently preparing the meeting dossier, completing the remaining ancillary activities, and remain on track to submit our NDA during the first half of 2027. This represents another important milestone for the program and keeps us on track for our anticipated regulatory timeline.

The program continues to execute according to the development plan we outlined for the investors. From a scientific perspective, I remain very excited about G-MELT. We believe it has the potential to fundamentally change procedural sedation by offering a rapid, IV-free, opioid-free alternative that addresses a significant unmet need across multiple procedural settings. Assuming a successful regulatory review, we continued to target a potential FDA approval in the first half of '28, followed by a commercial launch later that year.

Turning to YOCHIL or MELT-210, the simplest way to think about the program is G-MELT for pediatric patients. YOCHIL is being developed for children undergoing diagnostic and therapeutic endoscopic procedures. Today, oral midazolam is administered primarily as a syrup, which can be difficult for children to tolerate because of its taste and the challenges associated with administration. We believe an orally disintegrating tablet could provide a more convenient and child-friendly option while fitting within the dosing paradigm physicians already use for oral midazolam.

Earlier this year, we completed our End-of-Phase 2 meeting with the FDA. We are currently modifying our pharmacokinetics study protocol to align with the agency's feedback on this program. The development approach is a 505(b)(2) pathway to bridge to oral midazolam syrup through PK, and we expect to develop multiple dose strengths, likely four, to accommodate the current weight-based dosing paradigm. YOCHIL also benefits from the formulation, development, and regulatory experience we have generated through MELT-300, including use of the Zydis orally disintegrating tablet platform.

We continue to target an NDA submission in 2027. Together, G-MELT and YOCHIL represent the foundation of a broader procedural sedation platform addressing both adult and pediatric patients. We look forward to providing additional detail on the development plan for both programs at our Investor Day next March. With that, I'll turn the call over to the operator for Q&A.

Thank you. [Operator Instructions] The first question will come from Chase Knickerbocker with Craig-Hallum.

Mark, maybe just first to start on the national top three PBM win. Can you just maybe talk about exactly what that coverage constitutes. Is it, you know, kind of tier 1 preferred, like that other, you know, top three win that you already have?

Yes, I think the only thing we want to say about that coverage win is number one, it's obviously a top three PBM. Number two, it's for commercial lives. I think the third element is that these were lives that were formerly blocked, that we did not have access to. And then the fourth item, Chase, is the number of lives that we now have access to is in the many millions. And other than that, I think that's about all I can say. I don't want to go into the specific positioning on the formulary, but we're really excited about this coverage win.

And, you know, it's something that we promised our stockholders, and we were able to deliver actually, I think, ahead of time. We didn't think this would come until the first part of next year, but I know the VEVYE team is really pumped to have millions and millions of lives that they now have access to that were formerly blocked.

Got it. And maybe just a two-parter, one on IHEEZO, one on VEVYE. Just as we think about kind of the recent volume acceleration for IHEEZO, can you just discuss what percentage of that business is now in-office versus kind of retina as far as kind of characterizing that acceleration? And then just on VEVYE, Andrew, if you could just comment on kind of how you see ASP in the second half. Since there is still an impact from those kind of pre-business rule changes in the second quarter, is it fair to assume kind of continued sequential improvement in VEVYE ASP? Thanks.

Sure, thanks for that, Chase. So on IHEEZO, look, the ASC market is now effectively shut because of the loss of pass-through. I think the fact that we hit a record number in terms of unit demand for IHEEZO in the second quarter, which I don't think anyone expected, was an extraordinary result. And it really goes to the focus that the team has put on the in-office market, and that includes both retina as well as other in-office procedures. The in-office market, which we've talked about, which opens up about 2.5 million additional procedures for us, is a significant market, but it's one that we've really just barely scratched the surface on.

A significant amount of the growth in IHEEZO for the second quarter came in these retina practices that we've been targeting for the last year and a half or so. We're really making progress. We forecast that in the third quarter we would be set up well with the new 5-pack, the new pricing, the data that's starting to come out, and that would cause this acceleration in the second half of this year. But IHEEZO is definitely exceeding all of our expectations.

And to be clear, we've really simply just scratched the surface. We have probably less than 2% market share in the overall addressable market, less than 2%. And we continue to grow and pick up record numbers of accounts, and we're seeing that acceleration, by the way, in the third quarter. You'll see it in the numbers in the third quarter, and then the fourth quarter as Andrew discussed. But IHEEZO is going to be a really important part of us hitting our numbers for the second half. Andrew, do you want to talk about VEVYE?

Yes, absolutely. Thanks for the question. So with VEVYE ASP and generally anything going through the pharmacy benefit, we typically improved pricing throughout the year as patients are hitting the deductible. And certainly we're expecting to see that with VEVYE. But to your point about the amended business rules, we didn't get a full quarter benefit of that. And so now moving forward, obviously starting in Q3, we'll get the full benefit of those amended rules, which should add a little bit of additional positive momentum to VEVYE ASP going forward.

Thank you. And the next question will come from Steven Seedhouse of Cantor.

First, I just wanted to ask on TYRVAYA, and if you can give us a sense of what actually were the sales for that product, maybe in 2025, 2026 year-to-date, and whether it's growing or if it's stable or even declining slightly in recent years before you take over? And then also, what are you modeling for loss of exclusivity of that product?

Andrew, do you want to talk about what we know? I know that we're trying to keep things quiet as we get to the closing, but is there anything you can discuss on that front?

Yes, Steve, there's not a whole lot we can say until we actually own the asset. And so I think you can take a look at some of the Viatris' comments. Our focus right now though is closing as quickly as possible. We think there's going to be strategically really important assets for us. And so that's the primary focus is getting it closed. And then once closed, what we're guiding to is, you know, that it will contribute more than $30 million of revenue. We're also adding additional heads on the sales and commercial front with the product.

And those people are going to be not only promoting TYRVAYA, but also VEVYE. So we should see, regardless of the trajectory of the product currently, we're expecting our ability, we should have the ability to continue to grow it. And then in regards to loss of exclusivity, we're assuming the product will have exclusivity through 2034.

One other comment I would just add is that the operational synergy between these assets is remarkable, and I think you're going to see that probably as early as the fourth quarter. And you'll also see that these assets are clinically complementary. In going out and talking to dry eye professionals, you know, the ability to treat the disease with a chronic care product like VEVYE is our primary asset, I think is important, but also to supplement the treatment, the interest in supplementing the treatment with a product that nearly immediately produces tears like TYRVAYA is very strong, and it's much stronger than we had anticipated before we did our diligence on this product. And, you know, you'll be surprised about the degree to which these are clinically complementary and operationally synergistic.

All right, thanks. That's helpful color. And I wanted to also ask, on IHEEZO, I guess I'm just curious, like, where this such strong demand has been coming from specifically, because a lot of the tailwinds, the clinical data, obviously, QUELL is still running and that data is in the fourth quarter. And even the launch of your biosimilars that maybe provide some sort of synergy in the marketing effort, like that's sort of on the come still. And yet you still had this record demand amid all of this, you know, resetting of price and inventory and all this. So is there any way you can just articulate what specifically you think has been driving such strong demand and how likely that is to sort of continue into these subsequent quarters as you have these additional tailwinds coming online? Thanks.

Yes. Well, first of all, even though the demand is impressive and you're right, it is across the board, you know, the team has just done a phenomenal job growing that business in terms of new accounts and then pushing through, you know, units used within specific accounts. We're also picking up larger accounts that are using higher volumes within their practices. Once again, even though we've achieved, I think, a phenomenal result in the second quarter, we've really just barely scratched the surface. In terms of why doctors are encouraging us increasingly using IHEEZO, it's because the product is fantastic. It performs amazingly well clinically. It feels good on the patient's eye.

You know, it has predictable onset, predictable duration. And then, you know, the excipient that's in the product actually makes the eye feel better than the alternatives, which includes an injection into the eye of lidocaine to anesthetize the eye. So there are tremendous product attributes that we think give us huge advantages, and the word is spreading certainly among the retina community, but also within these multi-specialty practices that we're increasingly opening up.

So, you know, the in-office market is real. There's a growing market for cataract surgery, for example, in the office. And that's a market that we're picking up. So across the board, you should expect continued growth and acceleration for that product. And once again, we've really just barely scratched the surface, but probably, as I said, less than 2% of the addressable market.

Thank you. And the next question will come from Lachlan Hanbury-Brown with William Blair.

Maybe just a quick follow-up there on TYRVAYA and the sort of contribution to 2026. I appreciate that's obviously somewhat dependent on the exact timing of the close, but should we just be thinking about sort of [ prorating ] what you said about '27 for '26? And maybe would it also be accretive to EBITDA in '26, or are there some sort of initial maybe like the initial cost associated with the sort of closing integration that would affect that?

Yes. Hey, Lachlan. I think that's a fair assessment to kind of pro rata the guide for next year depending on closing, which like I said, we're rapidly trying to get that closed as fast as possible. And then do you think about operating margin and contribution this year? I think it's safe to say it's not going to, we don't expect it to pull down earnings this year. There may be some integration costs this first few months as we're implementing the product, getting it into our system. So expect a little bit higher cost in the first few months, but certainly beginning next year, those integration costs should largely have been cleared out, and we should have positive contributions from the product day one starting next year.

Got it. Thanks. And maybe another on VEVYE. Mark, I know you said you don't want to say too much about that new coverage. Can you at least give some commentary on, like, where the ASP from that coverage may end up relative to, you know, the current coverage or what you've been realizing? You know, is that an improvement? Is it about the same or is it worse than the current coverage and what you've been seeing? And maybe also related to VEVYE, you talked about the sampling program. Can you give us a sense of how impactful that is and maybe like, how much of the current volume has been going through that $0 first fill that this can maybe help to convert more quickly?

Yes, so, you know, in terms of the effect on ASP, simply put, we never sign deals unless there is a net improvement, you know, to ASP. We're not going to, you know, sign a deal unless at the end of the day we're not unable to make up the difference. So for example, if we take a lower net price but we're massively able to increase volume, the amount of revenue that we're able to generate from the franchise ultimately improves. And so we have, I think, a pretty good modeling on the effect now of these coverage opportunities. But in this one in particular, this is something that should improve our unit revenue for VEVYE.

In terms of the $0 first fill, we've built the company on a foundation of access. So, you know, for us, market access, simply put, means any patient in the United States that is in need of any of our medications will have affordable access to the product that they're in need of. And for us, when we were launching VEVYE, without the coverage, and frankly, our coverage has been pretty poor. As I said, the recent coverage win came from a PBM where we were really blocked. But, you know, for us, you know, we implemented a $0 first fill to ensure that everyone who needed VEVYE had access to VEVYE.

The problem with that is it's very expensive for us financially. And what we've, I think, realized is, you know, you'll see significant improvement financially with the sampling program that's now replacing the $0 first fill. Not only do you have the COGS cost with the $0 first fill program, you have all the processing fees, the pharmacy fees, distribution, and so on. And you're really reliant on getting a meaningful number of refills for that patient in order to make up for those investments. And the sampling program is, we believe, going to achieve the same effect in terms of giving patients access to the medication that they need at a far lower cost and ultimately a far more profitable structure for our stockholders.

Okay, thanks. So I guess should we just think about that showing through as maybe slightly lower actual like scripts per se that are written, but just a higher ASP per script that's written? So it effectively a price growth [indiscernible].

I don't know that I would think about it that way. I mean, I think that we're seeing higher volumes of prescriptions, both new prescriptions and total prescriptions as a result of this program. I think what Andrew said in his remarks, and Pat reinforced this, is that the business rule changes that we made most recently, the expectation, I think, among some was that this would constrict, you know, prescribing, it would constrict dispensing.

And the opposite has happened. So, these business rules, and I think this actually has exceeded our expectations, these business rules have not affected at all the demand for the product, and not only the demand, but our ability to ultimately process a prescription and dispense it.

You know, both NRx and TRx moved up meaningfully in the second quarter. And by the way, it's continuing even in the third quarter, which is extraordinary. So we're getting great productivity from the sales force. The business rules that Andrew and the team implemented, I think, were extremely successful so far. And we're in really good shape with our VEVYE franchise.

And the team is fantastic. There's also, by the way, a direct relationship, I think, between the investment in the field force and our ability to get new prescriptions in the door. So we're seeing that correlation, that connection. More reps is going to mean more NRx, and when you have a product as extraordinary as VEVYE, that's going to mean more TRx. And with more coverage, where you're making more money on a unit basis, that should give us increasing overall revenue for the franchise. Andrew, do you want to add to that at all?

I would just kind of reinforce what I said in the previous questions, which is, I think, with the coverage win considered, we do still expect ASP to improve for VEVYE throughout the year.

Thank you. And our next question is going to come from Thomas Shrader with [ U.S. Bank ].

Seems like all 50 balls are back in the air. A question on TYRVAYA and VEVYE. Are they going to be in lockstep, which is the sales force has both? And when you add a TYRVAYA sales force, they'll also have VEVYE, they'll have the same sampling. Is that the way to see it? You'll have two products that are essentially everybody in the sales force has?

Yes, I don't want to go into the specific strategy, Tom, too much, but what I can tell you is VEVYE is our primary product. It is the product, it's the lady that we went to the dance with. And it is the core focus of our team, and it will continue to be. But there is, as I said, tremendous operational synergy between these products, and they are clinically complementary. Pat, do you want to talk at all about what you intend to do on the VEVYE-TYRVAYA front?

Yes, thanks, Mark. You know, to the question, we're really excited about the complementary nature of these products. I mean, when you think about it, VEVYE has performed really, really well. And I think what we're really excited about when you think about this, just some context, we're in a very large and active market. Just to give context, this time last year we have a market that's up about 18%. And the branded RXs are representing over 75%. With VEVYE, the real key point here is we're focused on inflammation as the cornerstone to treating dry eye. We continue to see a positive experience and performs well.

And as we've expanded the team, I think we continue to see a positive experience growing on NRx, TRx, as well as writers. TYRVAYA helps us, one, open up another segment opportunity when it comes to basal tear production, which often is, you know, similar presenting in the inflammation patients. So we see an opportunity for both of these products to, one, grow our Harrow share to further help these patients and doctors that we cover right now and actually bring in more writers and grow our business.

Okay, and then on the biosimilars, obviously growing the brand is important, but protecting your price is a huge part of this game. Any thoughts on, I mean, Amgen seems to have done it, but any thoughts on, your strategy there or maybe one you want to answer even less, but I'm just curious what you can say.

I think right now, Tom, the team has received a tremendous amount of inbound interest in the product, and we're focused on really converting that interest to demand and revenue. Other than that, you know, I think we have a phenomenal market access strategy that's designed to, you know, maximally preserve pricing. And we have, I think, some unique advantages with our product over other choices, including the branded Lucentis as well as the other biosimilar. Andrew, do you want to comment on that at all?

Not really. We're obviously really ASP and maintaining net revenue per unit durability for the product is super important, as you pointed out. And so we, like Mark was saying, we do have a strategy to do that. We have a lot of experience doing this too with some of the other buy-and-bill products. Obviously, this is a little bit different, but you're still kind of in the same sort of, you know, it's going through the medical benefit. It's reimbursed on its own J-code or Q-code. Pardon me. So still a similar dynamic, and so we're using some of that experience to try to extend durability of both BYOOVIZ and when OPUVIZ launches OPUVIZ.

Okay, last one, which may be yes, no. IHEEZO in the surgical setting, is that gone forever or as you are generating clinical data, is there a way you might get some use back? It was a pretty decent market, and people loved the product. Is there any way back or is that just not worth it at this point?

Yes, to be very clear, if we have a minute of time to invest commercially making a sale, given what we're seeing in terms of new account development and reach within these practices, we're going to focus on where we know we are winning and where we have a massive amount of room, headroom, which is in-office in the retina market and in the in-office procedure market. So, you know, we have literally well over 10 million more procedures that we can address with this product on an annual basis.

And so certainly the surgical market is an attractive market. It's how we launched the product, but we have a massive market ahead of us in the interventional injection market, as well as the office procedure market, where we have a permanent product-specific J-code, reimbursement at better than 95%, and a sub-5% prior authorization rate. So we're having tremendous success in the office with retina professionals, as well as other in-office procedures. So that's where we're focusing and we're going to leave the surgical market alone right now.

Thank you. And the next question will come from Mayank Mamtani with B. Riley Securities.

So on the shareholder letter, you mentioned the third-party data undercounts VEVYE. Was just curious, Mark, if you could maybe comment on what you're seeing on the total dispense units that we may not see in IQVIA here. And, obviously trying to understand the volume demand to revenue conversion here. You know, to the extent you can maybe also comment on volume, how you might be tracking, versus another maybe incumbent brand, which is also helping expand the DED market. And then on the new PBM win, did you comment on what percentage, you know, of the new lives that you have was previously filling as cash pay versus completely blocked?

I'll take the cash pay versus covered answer, and so we don't break that out, you know, specifically, and we don't really intend to. Obviously, this is an incredibly competitive market. Andrew, do you want to talk a little bit about the data issue on VEVYE and reporting specifically, anything you want to add there?

Mark, I think that I'll just kind of reiterate some of the things that we said, like Mark was saying in the shareholder letter, that we are seeing an increase in, I would say, disparity between the data that the third-party aggregators are putting out and our internal data. You know, we saw our total brand-to-drive prescriptions reach about 14.6% at the end of June. That's up from last quarter and obviously almost nearly double from a year ago. And so that share that we're drawing, especially when you look at the year-over-year numbers, that's what's basically the old territory setup.

We were able to grow that prescription amount with a much smaller sales force. And we're just barely getting productivity from the new reps. So we're excited about what we're expecting to see in Q3 and Q4, and we're seeing this in the early days, is the reps are producing prescriptions. There's a direct correlation to number of feet on the street and increase in NRx and TRx. And that's only going to be furthered as we add TYRVAYA and some of the commercial organization from Viatris as well, which as Pat was talking about, they're also going to be selling VEVYE as well as TYRVAYA, which should just further accelerate our market position within dry eye between VEVYE and TYRVAYA with the acquisition close pending.

The other thing I would add is that the dashboard that I watch is our [ PhilRx ] dashboard, and as I've said on previous calls, I watch it like a hawk, almost like some investors might watch a stock ticker, I suppose. And what I'm seeing and what gives me confidence in the franchise and the great work that the team is doing is that I'm seeing higher highs and higher lows in daily volume. And so even tracking one Tuesday this week versus the prior Tuesday, just monitoring week-over-week data, once again, higher highs, higher lows, and, you know, one week doesn't necessarily make a trend, but that's happening certainly on the monthly data.

So we're really pleased with the work that the team is doing. There's a lot more work left to do, I would say. The second half is truly about commercial execution, and Pat and Maria and that whole VEVYE team, I have just tremendous confidence in their ability to make it happen and continue the trends that we're seeing on VEVYE.

Understood. And that's certainly what we are seeing on the IQVIA side. Just on pipeline, if I may, just a couple of quick ones. The ASRS interim data for IHEEZO was encouraging, but obviously a small sample size. So how do you see, you know, this QUELL data coming up, build on these learnings, you know, including the comparator arm, I think the same comparator arm you are using of some subconjunctival lidocaine superiority. I think you're trying to demonstrate on post-procedure pain and maybe some of the other more retina clinic workflow relevant endpoints. So just maybe talk about what does win look like to drive utilization against obviously a generic sort of market backdrop. And then lastly, for G-MELT, what are key questions for this pre-NDA meeting coming up in early 4Q? And do you anticipate most of your ancillary studies being wrapped up by the end of the year?

Yes, I'm going to turn both those questions over to Amir, but I do want to say just briefly on the QUELL data and the data that Dr. Dang made available at ASRS, that I always think of things from a patient's perspective. If I was a patient going in to get an intravitreal injection, and I'm going to get another injection of lidocaine in my eye and deal with the consequences of that, I would much rather prefer a single dose of IHEEZO. And so what we're really trying to demonstrate is that in terms of the anesthetic effect, it's the same. So, you know, you can either get a needle or you can get a topical drop. In terms of the anesthetic effect, it's the same.

And, you know, whether there's any difference in pain and, of course, patient preference. And so we always think of things from a consumer perspective, and we think that patients ultimately were going to prefer IHEEZO, and that's got to be borne out in the data, and that's really the focus of the great work that Amir and his team are doing. Amir, do you want to add to the QUELL study that's ongoing and then talk about anything you can about the pre-NDA meeting?

Thanks, Mark. Yes. So, real quickly, on QUELL, this is a double-masked control trial. So, as far as any current data, we obviously don't have any, but the study is well-enrolling, and we anticipate to have the enrollment completion later this year, and then we'll have results later this year. That said, the kind of endpoints we're looking at are substantially twofold. One, we're going to look at the numbing effect where we want to show that the product obviously numbs just as good as the lidocaine subconj. But more importantly, we're looking at patient outcomes, right?

So from a patient outcomes perspective, we have a whole slew of symptoms that we track, as well as the overall satisfaction by the patient, all the way through 24 hours post-injection. So all of those metrics will come out, and we're pretty confident. Now remember, everything that we are doing is based on what we've seen already. This isn't just started necessarily this quarter. We started this journey on evidence generation about 20 months ago. And a lot of this data is trickling out and supporting our continued sort of benefit that we are seeing from the patients using IHEEZO or in procedures especially.

On G-MELT, this is a pre-NDA meeting, and the nature of a pre-NDA meeting is really oriented around the submission package. What is it you're putting in, and what is the format, some of the basic necessities as far as the review division is concerned. That said, we will have CMC-oriented discussion, and most of the other ancillary programs, the PK studies, et cetera, will be discussed during this meeting. So it will be an important meeting, but that said, there isn't one specific thing in focus. It's the whole constellation of data that we're going to put into the NDA.

Thank you. The only thing I would add, by the way, on QUELL is it is a study that's taking place under an IND, which is really important as well, and that could have a significant impact, some advantages pending the outcome of the data.

Thank you. And the next question comes from Jeffrey Cohen with Ladenburg Thalmann.

Just two from our end. Could you talk about the contact lens wearers and TYRVAYA and perhaps some pickup there from VEVYE in dry eye? I know it's a bit early, but do you expect any access program sampling programs, couponing, et cetera, on TYRVAYA as you launch it in the back half?

What was the first question, Jeff? I'm sorry. TYRVAYA?

I wanted to know as far as contact lens wearers in your dry eye franchise.

Yes. So, look, all of the other products that are administered on the eye for contact lens wearers require the patient to remove their contact lenses. And, you know, that takes time, and it is probably true that some patients don't do that. But one of the great advantages to TYRVAYA is that for the 45 million folks in the United States that are contact lens wearers, this is a unique product for them specifically. This is a product, by the way, that, you know, over the last couple of years has had, you know, significant revenue.

What we've been able to demonstrate and what we intend to show once we close on the product is that we can restore that revenue structure and grow the business. And we think that is certainly possible. It hasn't gotten a lot of attention over the last couple of years. And we intend to really focus in on making sure that certainly the contact lens wearers have access to it, but also other patients that we can serve that are suffering from dry eye disease and who could benefit from TYRVAYA. So we have high hopes for TYRVAYA, but that said, VEVYE is going to continue to always be our baby. It's where we focus. It is the lady that we brought to the dance. And we think that VEVYE will continue to be the primary driver of our dry eye franchise for sure.

In terms of the access programs, I don't want to, you know, get into specifics about what we intend to do to ensure access to TYRVAYA. But what I can say is that we will continue to implement access programs that ensure that every patient in need has access to all Harrow products, rich or poor, good insurance, bad insurance, or no insurance. That's how we built the business, that is the foundation of who we are culturally, and that's the way we'll continue to be. Some companies talk a lot about access. We act a lot on access and have programs to make sure patients get what they need. That will certainly be the case with TYRVAYA.

Thanks, Mark, that's helpful. And then just one more quick question on the compounding business. I know we haven't talked about that. Any net changes there for the quarter? And as far as the second half outlook, should we expect a similar run rate to what we saw during Q2?

Do you want to talk at all about the compounded? I mean, what I said in the letter is really, I think, important, and that is, we've had an inventory recovery. So we now have inventory, which is half the battle. We've demonstrated that when we have inventory, we grow. You know, that said, we've talked about on past calls that our interest is in converting compounded units to branded units where that is possible. We feel that that's not only in many cases better for the patient, but it's better financially for Harrow stockholders. But we do expect that business to grow in the third and fourth quarters. Andrew, do you want to add to that at all?

Yes, Jeff, we guided, I think in March, the March conference call we guided that business. We thought we'd do about $60 million to $65 million in revenue. That guide is still in place. So that implies a continued increase in revenues through the second half of the year. And then importantly, we should see improvement in gross margins from that business as well as we progress through the year and start getting more revenue on top of the fixed costs that are built into that operating structure.

Thank you. And the next question will come from Nelson Cox with Lake Street Capital.

I wanted to ask on the $250 million revenue exit rate from 2027, which did not when first issued have some of the more recent adds to the portfolio included in it. The question is why should we not view those incremental to the goal rather than being a part of it, or had the $250 million goal always baked in some kind of business development activities to supplement that portfolio at the time when you initially made that guidance?

Well, thank you for that, Nelson. Yes, we have a history of doing BD for products to generate revenue. And so certainly I think it would be reasonable to believe that we would do BD, but that was really not baked into that goal. The belief is that we can achieve that with the products that we have. We, you know, I must say, have an incredible team, and they're all focused on hitting that number. It is a difficult thing to achieve for sure, but I do believe we can do that. And there is a pathway to achieving that with the products that we had.

[Ex-TYRVAYA]. TYRVAYA certainly helps, though. So we'll see where we land. We've got to get that product closed. But it definitely is additive and should be helpful in getting us to that number. But the idea was that we would hit that number without any business development activities.

Thank you. I am showing no further questions at this time. I will now turn the call back over to Mark for closing remarks.

Thank you, operator. I will close where I began. The first half of 2026 was about setting the table, expanding our commercial organization, improving pricing, normalizing inventory, launching new products, and advancing our pipeline. We did what we said we would do. The second half is about serving the meal. Demand across every one of our growth drivers is strengthening, our commercial organization is larger and more capable than it has ever been, and the investments we made in the first half are already showing up in the business today. That is why we are reiterating our full year guidance and why I remain confident in our ability to deliver it.

I want to end this call by letting our stockholders know that people within this organization matter. After nearly 15 years as the leader of this business, we have simply never had the level of talent we now have throughout the business. We have significantly upgraded our talent level, and this is most pronounced in our commercial group. I am betting on our commercial team to make it happen, and I believe you should too. The table is set. Now we serve. One final note. We announced our Investor Day on March 22, 2027, in New York City. It's going to be a tremendous event. Please mark your calendars. We hope to provide more information about this event later in the year. Thank you, and that will conclude our call.

This concludes today's conference call. Thank you for participating. You may now disconnect.

Good morning, and welcome to Harrow's First Quarter 2026 Earnings Conference Call. My name is Michelle, and I will be your operator for today's call. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the call over to Mike Biega, Vice President of Investor Relations and Communications for Harrow. Please go ahead.

Thank you, operator. Good morning, and welcome to Harrow's first quarter 2026 earnings conference call. My name is Mike Biega, Vice President of Investor Relations and Communications, and I'm excited to be introducing today's call.

The company's remarks may include forward-looking statements within the meaning of federal securities laws. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond Harrow's control, including risks and uncertainties described from time to time in its SEC filings, such as the risks and uncertainties related to the company's ability to make commercially available its FDA-approved products and compounded formulations and technologies and FDA approval of certain drug candidates in a timely manner or at all.

For a list and description of those risks and uncertainties, please see the Risk Factors section of the company's most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission. Harrow's results may differ materially from those projected. Harrow disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise.

This conference call contains time-sensitive information and is accurate only as of today.

Joining me on today's call are Mark L. Baum, Chief Executive Officer; Andrew Boll, President and Chief Financial Officer; Pat Sullivan, Chief Commercial Officer; and Amir Shojaei, Chief Scientific Officer.

With that, I would like to turn the call over to Mark. Mark?

Thank you, and good morning, everyone. To begin, as a growth-oriented business, the fuel for our success is and will always be demand. Without buyers seeing value in Harrow's products, ordering and reordering them, we wouldn't have a business. So demand is the key. And from that standpoint, the underlying fundamentals of Harrow have never been stronger.

While the headline revenue number this quarter reflects a specific isolated dynamic, let me be clear to my fellow stockholders, our data demonstrates that demand for our key growth drivers is accelerating.

Further, our market share capture is sustainable and will translate into profitable revenue growth. The $8 million revenue reduction in the first quarter was specifically tied to VEVYE. As detailed in my letter to stockholders, the surge that we saw in demand from patients with high deductibles from this new band of commercial coverage that we were so excited about, it just outpaced our initial financial modeling assumptions.

Andrew will discuss this in greater detail shortly. However, we identified this issue. We corrected it. And importantly, our fix to return to our net pricing assumptions has shown negligible impact on the underlying new prescription VEVYE demand. That's the key.

With the high deductible season largely behind us and new business rules in place, we expect to realize the full financial benefit of our expanded coverage moving forward, starting in the second quarter.

I want to go back to demand, though, because a lack of demand in the face of a concerted commercial effort is nearly impossible to remedy. Across our portfolio and specifically with our key growth driver products, we do not have that problem.

In fact, demand trends are strong, even for what is traditionally a weaker first quarter period due to standard industry seasonality. Moreover, you've probably seen on LinkedIn that we've hired more than 90 new sales professionals. So our promised commercial investments, that is doubling our sales forces in dry eye and surgical and bolstering other teams, are complete.

We are now entering a period where the work we've been doing over the past several years is translating into meaningful sustained growth in demand, and this will in turn convert to revenue.

Across VEVYE, IHEEZO, and TRIESENCE, our core growth drivers, we are seeing strong durable demand trends that are at or above our internal expectations. And in our business, once again, operational issues, they can be fixed. A lack of demand cannot.

Let me provide some additional color on a few key products. On VEVYE, we are seeing record prescription growth, continued market share gains and increasing prescriber adoption. The product has now reached a highly meaningful position in the market, having officially surpassed XIIDRA in total prescriptions as of the end of March as we continue to close the gap with other category leaders.

Crucially, this happened with half the number of reps we now have deployed. We are positioned to see this momentum accelerate, especially as we continue to successfully gain additional positive coverage changes, which we expect over the next 12 to 18 months. I'm especially pleased that more recently, we are seeing higher daily new prescription highs and higher lows. Breaking demand trend lines for a chronic care product to the upside is a very good thing.

IHEEZO demand continues to build across both retina and in-office accounts. We're seeing record numbers of new accounts, and this trend has continued into the second quarter. We are still early in unlocking the full opportunity here. And as we move into the second half of the year with improved pricing, new packaging and upcoming clinical data specific to IHEEZO in retina procedures, we're positioning IHEEZO for a step change in growth.

TRIESENCE is also demonstrating the kind of consistency that we expect. Even in what is typically a more challenging seasonal period for surgery, demand continued to grow sequentially with increasing adoption and strong reorder behavior. These are clear indicators that the product is gaining traction in clinical practice.

Following my recent time in the field with several large new TRIESENCE accounts, it is clear to me that our expansion into the surgical inflammation market is bearing fruit and will be a part of our long-term revenue growth strategy. Our Access+ cash pay business, which includes both our branded and compounded products, having successfully worked through prior inventory constraints, is also on track. We are currently increasing safety stock and expanding the Access+ sales team, positioning this team to enter growth mode so we can deliver essential, affordable cash pay products that our customers rely on.

As Pat will discuss shortly, these are the exact demand trends we look for across our portfolio, growing demand signals expanding account adoption and improving execution, leading to greater breadth and depth within those accounts.

As I look at Harrow today, I've never been more confident about where we are or where we're going. Simply put, the business is positioned beautifully for the balance of this year and has never been more valuable.

A few more points on the second half setup though. One, as I mentioned, we made targeted high conviction investments to scale our commercial platform and unlock the full potential of our portfolio. We recruited top talent to Harrow. That work is now complete. We've built the commercial infrastructure, expanded our reach and attracted the exact kind of talent that wins in this industry. What that means is straightforward. We now have the engine in place to convert the demand that we're seeing into sustained revenue and profitability performance.

As we move forward, several factors support strong and sustainable growth. First, our core products operate in large, underpenetrated markets with significant runways ahead. These are not short-cycle opportunities. These are durable growth platforms.

Second, awareness is building. New account starts are accelerating. Breadth and depth within accounts are expanding, and these factors drive the value of our products within our customers' practices in a highly meaningful way. Third, refill rates and reorder rates that are at or above our internal estimates support bullish demand metrics for our key products.

And fourth, the most challenging part of the year is behind us. Some of you have heard one of my mantras, and that is that at Harrow, we're not interested in mere activity. We celebrate economic accomplishment. We focus on economic accomplishment.

And as we move through the balance of 2026, we expect to see accelerating momentum as our commercial investments fully translate into financial results or economic accomplishment. The nonrecurring VEVYE revenue modeling dynamic does not change Harrow's trajectory.

If anything, it reinforces how powerful the underlying business is and what can come from VEVYE, especially as these new patients refill their prescriptions in a profitable way for our stockholders. We are executing, building momentum and it is clearly showing in the demand data.

Because of this, underlying demand is tracking in line with or above our expectations. And therefore, we're fully reaffirming our 2026 revenue guidance of between $350 million to $365 million for the full year.

Furthermore, this accelerating commercial engine underpins our unified corporate initiative to achieve $250 million in quarterly revenue by the end of 2027.

I will now turn the call over to Andrew Boll, our President and Chief Financial Officer. Andrew?

Good morning, everyone. For the first quarter of 2026, we reported consolidated revenues of $44.2 million and adjusted EBITDA of negative $12.7 million.

As we previously communicated, Q1 was expected to be the lowest revenue quarter of the year. This reflects several factors, as expected, a minimal GAAP contribution from IHEEZO as channel inventories absorbed, and softer revenue from the compounding business as we work through prior inventory constraints.

Breaking down Q1 performance by product, VEVYE generated about $20.9 million in revenue. IHEEZO contributed $1.9 million, in line with expectations. Our specialty and TRIESENCE portfolio delivered $7.8 million and Access+ revenue was $13.5 million.

As Mark noted, during the quarter, we experienced a gross to net modeling dynamic related to the VEVYE coverage rollout, which resulted in a discrete reduction of reported revenue by approximately $8 million.

To provide additional financial context, ahead of the January 1 coverage launch, we implemented business rules based on specific assumptions regarding patient mix and patient out-of-pocket costs. While January net pricing tracked in line with our forecast, the mix shifted sharply as the quarter progressed. We saw a significantly higher-than-anticipated proportion of high deductible patients filling prescriptions through their pharmacy benefit and our average out-of-pocket buydowns increased rapidly.

This growing utilization drove incremental gross to net pressure beyond our internal assumptions, resulting in lower realized net revenue per unit for the period. Due to the standard industry lag in claims reporting, the full magnitude of this mix shift was confirmed in mid-April.

We act immediately, implementing targeted business rule changes, including strict caps and co-pay buydowns and other program refinements to protect our net pricing going forward. These program changes have isolated this to be primarily a first quarter issue, and we are now well positioned to receive the complete economic benefit we expect from our expanded coverage moving forward beginning in Q2.

Based on updated modeling and what we have seen through April, net pricing is much better aligned with our internal expectations and should be notably higher than in the first quarter.

Importantly, early indicators prove these changes have not negatively impacted underlying demand or patient access to VEVYE. Given these adjustments and current demand trends, we expect VEVYE to deliver sequential growth and remain fully on track to exceed our $100 million revenue outlook for the year.

Looking ahead to the second quarter, we expect total revenues to be in the range of $71 million to $81 million. At the product level, VEVYE is expected to show sequential growth. We should see IHEEZO revenue start back in Q2, though likely still below prior year levels due to channel dynamics and dependent upon stocking levels associated with our new 5-pack presentation. We will also begin to recognize initial revenues from BYOOVIZ as distributors take on initial stocking orders.

As Mark already stated, we are reiterating our full year 2026 revenue guidance of $350 million to $365 million. Based on current demand trends and customer interactions, we expect the second half of the year to be even stronger than initially anticipated.

We have clear visibility into several catalysts that support this robust second half, including continued growth in demand across our core commercial drivers, full deployment of the expanded VEVYE sales force with a modest impact in Q2 and a highly meaningful contribution beginning in the second half of the year.

Realization of the full financial benefit from expanded coverage for VEVYE following our mid-April business rule adjustments, the commercial launch of BYOOVIZ on July 1, the permanent J-code for IOPIDINE 1% becoming effective July 1, potentially expanding utilization and in-office procedural setting, an approximate 20% to 25% improvement in IHEEZO net pricing, along with the introduction of multiunit packaging beginning in Q3.

Upcoming clinical milestones for IHEEZO, including initial retina data at the ASRS meeting in July and top line results from the QUELL study in the fourth quarter. And finally, continued growth in TRIESENCE, building on the momentum in ocular inflammation with a dedicated sales force that recently doubled in size. Taken together, these drivers give us high confidence in accelerating growth and improved financial performance as we move through the remainder of 2026.

I'll now turn it over to Chief Commercial Officer, Pat Sullivan.

Thanks, Andrew. Good morning, everyone. I will detail the commercial execution across our portfolio. The thread that runs through every one of these slides is exactly the same. Demand is accelerating, access is improving, and our scaled commercial organization is now actively converting that demand into revenue.

Starting with VEVYE. The 4 numbers at the top of this slide tell the demand story. New prescriptions grew approximately 25% sequentially. Total prescriptions grew about 11%. Our prescriber base expanded by another 12% sequentially, and we exited March at roughly 14% branded share, officially surpassing XIIDRA on a monthly TRx basis and steadily gaining ground on MIEBO.

Crucially, all of this was achieved with a smaller sales force of fewer than 50 representatives. Now that we have doubled the VEVYE team, we are aggressively deploying these new reps into both uncovered and underserved territories, which will directly fuel further growth in NRx and TRx. This is happening in a market that has real underlying tailwinds. The dry eye category has grown 20% year-over-year in prescription volume in each of the last 2 years, and VEVYE was effectively the only branded product to grow in Q1. We are actively taking share in an expanding market, and that is the absolute cleanest signal you can get that the brand is winning on its own merit.

Moving to IHEEZO. Demand continues to build. Unit demand grew 18% year-over-year. New ordering accounts increased 21% in the quarter and total accounts are up nearly 50% versus last year. Retina remains the core driver, representing over 80% of volume and the momentum we saw in Q1 has continued in the early part of Q2.

Interest in IHEEZO continues to build with demand increasing and new accounts continuing to come on board. There is substantial runway ahead within the retina market, and we are starting to see early and encouraging signs of adoption in the in-office setting. That expanding interest across settings reflects growing physician familiarity and confidence in the product and reinforces our view of the broader long-term opportunity for IHEEZO.

Looking ahead, this growth story is driven by 2 engines: continued momentum in retina; and expansion into the broader in-office market. What underpins both is a very strong refill dynamic. Once a practice adopts IHEEZO, they continue to reorder. We also have 4 distinct catalysts that will drive the next step change in growth.

First, expanding into the full in-office market adds more than 2.5 million procedures to the addressable opportunity. This expansion is underway and off to a strong start. Second, the first available retina-specific clinical data begins reading out in July, followed by additional data in the fourth quarter, which is designed to accelerate adoption.

Third, we are launching multiunit packaging tailored for high-volume practices. And fourth, we expect a meaningful improvement in net pricing in the second half of the year. These 4 catalysts completely underpin our conviction in IHEEZO's accelerating trajectory from Q3 onwards.

On TRIESENCE, the headline number is 136% year-over-year unit volume. March alone was up 113% year-over-year. This is now our sixth consecutive quarter of demand growth and unit demand has grown roughly 250% over those 6 quarters. The composition of this growth matters. 44% of Q1 volume came from the ocular surgery accounts, and we expect that segment to drive the majority of new volume going forward.

New account growth was approximately 28% sequentially. We are seeing increasing integration into the procedural workflows, particularly among cataract surgeons, driven by the product's ability to simplify postoperative care and improve the patient experience. That value proposition is directly translating into reordering.

In addition, our label expansion study in cataract surgery and pain is underway, which is positioned to materially expand the long-term opportunity.

This slide is a reminder of the sheer breadth of what sits behind our 3 lead products. We have one of, if not the largest, portfolios of ophthalmic prescription medications in the U.S. market, spanning specialty steroids, NSAIDs and anti-inflammatories, antihistamines, antibiotics, plus the most comprehensive ophthalmic compounded portfolio in the U.S. market.

Two highlights from Q1. We secured the IOPIDINE J-code, which I will cover in a moment, and we are unlocking the value of 2 additional historically underappreciated assets. Each of these assets is positioned to enter new on-label markets and contribute meaningful incremental revenue.

VERKAZIA is the first and only label product for vernal keratoconjunctivitis, a devastating form of severe ocular allergies that affects children and adults. Our research clearly shows the degree to which the disease is underdiagnosed. We intend to share our plans regarding VERKAZIA opportunity in the near term.

The second is NATACYN, a product for fungal blepharitis and other sight-threatening fungal infections. We are conducting a study for that product, and we'll share more information later this year.

Lastly, within our Access+ cash pay business, our supply chain operations successfully cleared the back orders accumulated last year for certain compounded products, rebuilt inventory across the key stockkeeping units and completely restored the operational confidence our customers expect.

Let me close on IOPIDINE 1%, the only FDA-approved therapy to prevent intraocular pressure spikes following various in-office procedures, backed by strong, well-established clinical data supporting its use in this setting.

Despite that clinical profile, IOPIDINE has historically been underutilized for one specific reason. Physicians have no reimbursement pathway and the product sat as a cost center within capitated fees. That fundamentally changes on July 1 when the permanent J-code takes effect at ASP plus 6%.

Physician incentives are now perfectly aligned with evidence-based practice. The addressable market for laser procedures alone exceeds 1.5 million annual use cases. There is no FDA-approved alternative with an established J-code.

Critically, IOPIDINE runs through the exact same in-office call point as IHEEZO, meaning we are directly leveraging existing commercial relationships rather than building new ones. We expect this to be highly incremental, high-margin contributor as we move through the second half of this year.

To summarize the commercial picture, VEVYE is taking share in a growing market and now has the access and sales force density to dramatically accelerate. IHEEZO's demand continues to grow sequentially, armed with 4 independent growth catalysts landing in the second half, alongside continued strength in retina and a highly successful expansion into the in-office setting.

TRIESENCE has delivered 6 straight quarters of growth with a major label expansion in motion. And IOPIDINE hits a critical reimbursement inflection on July 1 that unlocks a market that has been waiting for it. Demand across the entire portfolio is robust, and our commercial organization has never been better positioned to convert it.

With that, I will now turn the call over to Amir to discuss the assets we recently acquired from Melt Pharmaceuticals.

Thanks, Pat. I wanted to spend a few minutes on G-MELT, our IV and opioid-free procedural sedation candidate. Having spent nearly 30 years in drug development, advancing major global assets, I view G-MELT as a pipeline candidate of the highest caliber. It is uniquely positioned to disrupt standard procedural sedation and positively impact millions of patients.

Regarding our clinical and regulatory progress, following the acquisition of Melt, the program's required deliverables included 3 pharmacokinetic studies and a nonclinical toxicology study. We have successfully initiated all of these programs. The nonclinical study is now in the reporting phase and the first pharmacokinetic study has also been completed and is in the CSR drafting stage.

The other 2 PK studies are the renal and hepatic impairment study, both of which are underway, and we anticipate final reports in Q4 2026. On the manufacturing front, our integration and scale-up activities are advancing rapidly. A major manufacturing campaign scheduled for later this quarter will formalize the data package required for our NDA submission.

Based on our current trajectory, we remain firmly on track with our targeted time lines. By our next quarterly call, we expect to provide a definitive update regarding our pre-NDA meeting date with the FDA.

With that, I would now like to turn it over to our operator for Q&A.

[Operator Instructions] Our first question will come from Timur Ivannikov with Cantor.

This is Timur Ivannikov on for Steve Seedhouse. So in terms of VEVYE, could you talk about the gross to net adjustment in more detail? And to what extent this was driven by typical seasonality? And maybe what were the major buckets such as co-pay assistance, high deductible buydowns, cash pay economics? And to what extent this gross to net adjustment is isolated to Q1?

Thank you, Timur. First of all, the first quarter typically for Part D products with the deductibles resetting is always a challenging period for these types of products. As we noted, I think, in one of our documents, the dry eye category for the first quarter was actually down in total prescriptions.

In fact, the branded market was down 18%. That's in the face of the overall category improving better than 20% for the last 2 years. But what we highlighted and what I think is important is that our NRx growth, our new prescription growth was actually up 25% sequentially in the face of a branded market that was down 18%.

Our TRx growth was up 11% once again in the face of a branded market that was down 18%. And with CVS specifically, the new Benefit Manager that we brought on, the new coverage on the commercial side, we were up 170% in sequential growth with that set of plans alone. So we did very well. What I would say is, and I want Andrew to comment on this, is that we had to make a bet with our model in terms of what the likely volume would be for patients with high deductibles.

And frankly, the surge in volume that we saw was so large that it really just exceeded the modeling that Andrew and his team had done. On the one hand, it's a bad thing to see this $8 million revenue reduction as a result of this.

But on the other hand, we do know that we retain these commercial patients for a long time. And while we didn't do as well with these patients during the month of January and February and March, we're going to do very well with them on a go-forward basis.

Andrew, do you want to specifically add to that regarding gross to net in the first quarter and any co-pay assistance?

Yes. Timur, thanks for the question. Just to kind of add on to what Mark was saying, as we kind of looked at the average net pricing for these CVS patients in particular, and our out-of-pocket paydown for patients in general, the CVS patients were coming in about 40% higher out-of-pocket buydown amount than any other covered patient for us.

And so as -- obviously, when we modeled things, we didn't model -- we didn't expect that buydown to be significantly higher for these patients. And so once we accumulated all the data and can make a decision based on the trends in mid-April, we adjusted those rules to basically take down the amount of out-of-pocket buydowns that we were putting into that patient bucket.

We also made some tweaks that will affect patients on other plans as well, but should improve net pricing. I think it will have minimal impact on what that patient's actual out-of-pocket is. I think in some cases, actually the patient's out-of-pocket will get better based on just some of these tweaks we did to the business rule.

And so as we kind of talked through the initial trends that we're seeing importantly is that there's minimal to no impact to demand, at least what we're seeing here the -- these first few weeks of implementation of the new business rules.

And importantly, we will now go from those CVS patients essentially being on average negative revenue to much more positive and contributing to overall net revenue for -- on a go-forward basis.

And the next question is going to come from Chase Knickerbocker with Craig-Hallum.

Maybe just to kind of ask it directly on VEVYE around ASPs. You had mentioned kind of an $8 million impact if the business rules have been changed for the entirety of the first quarter. So as we look kind of in Q2 and onward, I mean, that's about a, call it, mid-30s percent kind of impact. Is that what we should be assuming sort of from an increase and potential increase of ASP or maybe just making sure that I'm kind of thinking about that the right way?

Andrew, I don't know that we can give a specific answer regarding ASP, but I know that you've done some calculations on what the likely improvement is, and it's impressive. Do you want to try and tackle that one?

Yes. And Chase, obviously, that's assuming status quo. But I think that's a reasonable assumption to assume, roughly 30% increase.

Helpful. And maybe just you guys have a couple of weeks of additional visibility relative to us, obviously, on kind of the VEVYE data. So far, since those business rule changes, could you maybe just give us some commentary as far as what you've seen in recent weeks as it relates to volume, just kind of confirming the -- this isn't having an impact? And maybe around those -- around that, Andrew, if you could kind of explain in a little bit greater detail how the out-of-pockets could actually kind of be coming down for these patients with these business changes, respecting the fact that there's a lot of detail here?

Thanks for that, Chase. In terms of VEVYE volumes more recently in the last, let's say, 20 days even, and I think I mentioned this in my stockholder letter, but I watch the new prescription volumes like a hawk. I mean, literally, multiple times a day, we have a dashboard that gives us real-time data as to what's coming in.

And I know, for example, at 4:00 Central what the likely total day volume will be because we've got a lot of data in our system in terms of what the balance of the day would look like as the Mountain Time and Pacific physicians begin to write for VEVYE.

But I think what I'm really pleased with, and I mentioned this in my opening remarks, is that I am seeing higher highs and higher lows in the last 15 days, especially. And I think that's as a result of these new reps actually being out in the field, making the calls and beginning to bear -- their work beginning to bear fruit. That's really exciting.

In particular, I'm seeing days in the week that are usually lower in volume than other days in the week. And now all of a sudden, they're popping up, breaking trend lines and becoming much better days in the week. So we're having record days, record weeks and as I said, higher highs and higher lows. That's really positive, and we can see those trend lines breaking. So the work that we are doing out in the field with this doubling of the sales force is beginning to have an impact. Andrew, do you want to talk about patient out-of-pocket?

Yes. And Chase, I'm going to try to speak to this without giving too much detail because a lot of our competitors listen to this call as well. But what I would say is we are going to leverage our VAFA program and cash pay program with some of those patients as well, which, as you know, the cash pay price there is $59 for the product.

And the next question comes from Lachlan Hanbury-Brown with William Blair.

I guess, maybe I'll ask one on IHEEZO. Just how should we think about the dynamics in Q2? Is channel inventory sort of largely normalized at this point? And then how do we think about the sort of sunsetting of the current packaging versus the introduction of the new packaging and how that may impact Q2?

Yes. I'll make a few comments, Lachlan, and then turn it over to Andrew. But I think a couple of important data points. One is 2025, we saw 30% of our unit volume come from the ASC setting. I think you know that. The ASC setting in the Q1 period was down to 18%. And I think as I said in the stockholder letter, we should be able to eclipse the entirety of that ASC volume through the in-office sales that we're beginning to see flow by the end of the year. So that's very promising.

Obviously, we've now moved to a 5-pack presentation. We've made some, I think, very significant improvements to ASP that will begin to kick in, in the third quarter. And I think we even referenced the figure of better than 20% improvement. So that's really, I think, important. And I think what our sales force is particularly excited about is finally having some retina-specific data to be able to present to accounts.

So everything that we've done, we've got a few percentage points of market share, but not many. The vast, vast majority of the market opportunity is -- remains underpenetrated -- unpenetrated. And we believe that this data is going to certainly help us -- and that's showing up, by the way, in Q2. We're seeing record new account starts.

And that, I think, bodes well for not only the second quarter, but the third quarter and beyond. That's what I think gives us so much confidence in our -- reiteration of our guidance.

Andrew, do you want to talk about the stocking dynamic and what to expect in Q2 versus Q3?

Yes, absolutely. Lachlan. So second quarter revenue for IHEEZO, we're expecting to be -- still be somewhat muted, especially compared to the second quarter last year. We're still working through that remainder of channel inventory that was taken in Q4 and the loss of pass-through.

But to Mark and Pat's points, we're seeing a big increase in demand, especially on the retina side, a lot of new accounts coming through. So a lot of the -- any revenue that we're going to be booking will be below last year, but we should start seeing revenue start increasing from IHEEZO and then get to more of a normalized level beginning in Q3 and Q4, especially as we introduce this new multipack option, which we will commercially launch in July of this year.

And maybe if I could just also ask on IOPIDINE 1% with the new J-code. So how should we think about that adoption and the market opportunity? Obviously, a lot of procedures out there where it could be used, but just as we think about how it changes in terms of the contribution it makes starting in Q3, is that going to be a meaningful driver of the back half, or is it more incremental, especially in light of some of the changes with VEVYE and IHEEZO trials?

Yes. I would definitely say it's going to be an incremental contributor on the launch in the third quarter and the fourth quarter of this year. We're more bullish on the contribution in terms of it showing up relative to our overall size in 2027. But we're really pleased to have a J-code. It is a sizable market.

And frankly, the laser procedure market, which is what we kind of quote in terms of the overall TAM at better than 1.5 million annual procedures, is really only a fraction of the potential use cases of the product. There are a lot of procedures that occur in the office that can induce a pressure spike.

And right now, these offices are using a variety of off-label products, once again, that are paid for out of a capitated fee. And I think that the opportunity to use something that is on label, that is reimbursable at ASP plus is very attractive. And we've done a meaningful amount of market research to validate that. So we're pleased to get that launched. It will be incremental this year. It will show up, I think, with bigger numbers in 2027.

And our next question is going to come from Tom Shrader with BTIG.

Kind of one more on VEVYE. Can you give us a remedial rundown of the information flow, why you learned so late, why it took 4 months for you to get a hint that this problem was going on? Because I feel like you warned on everything this quarter, but then this one hit. And is that solved? And then one quick one on IHEEZO. It's interesting to see you still have 18% ASC use. Do you think that's stable? Do you think that's people who like it enough that are eating the cost? Or is that 18% going to continue to decline?

Thank you for that, Tom. I'm going to take the last question first, and then I'll ask Andrew to talk about timing because I think it's really important. Our stockholders, I think, hopefully will appreciate after Andrew explains this, Why? This is not a real-time situation. You can't just make a decision, change business rules on a real-time basis and that we actually acted expeditiously once we figure this out, and Andrew will talk on that.

But in terms of IHEEZO and the ASC, the IHEEZO business in the ASC is going to go and probably is now at 0. So these ASCs are not going to be purchasing IHEEZO for procedures in that environment. What we can say is that the unit volumes that we formally had -- and I'm not talking about the 18% that we had in the first quarter, but I'm talking about a more normalized view of what we had in the year 2025 in the ASC environment when those units represented 30% of the overall volume. Those are the unit volumes that we expect to replace with in-office use cases by the end of the year. So it's a larger number overall, and it will contribute meaningfully, I think, to our revenue in 2026 and certainly in 2027. But yes, the ASC business is going to go to 0.

The good news for us is that we have durable sustainable reimbursement in the in-office market. And I would say we have nearly pervasive coverage, nearly pervasive coverage, better than 95% coverage and a prior authorization rate that is sub-5%. So extraordinary coverage in office, and that is durable.

Andrew, do you want to describe, I think, in more detail, the timing of the work that you and your team did on the business rules?

Yes, absolutely, Tom. I appreciate the question. So first of all, there's -- it's more than just one data set that we use to assess and calculate a lot of these figures. And so it's co-pay data, it's the claims data from the payer, it's script data from our partners and IQVIA that we're using. And so as we're getting that data, we're making assumptions.

But January, which came in -- middle of February, when you have all of the data and you can calculate and analyze it, that came in pretty much in line with what we were anticipating. And so middle of February, we thought we were in pretty good shape.

When the February data came in, that's when sort of our, I would say, our incentives went up. These numbers are coming in much higher than we thought or anticipated. But we didn't want to make a decision based on that single data point. That single data point being in the month of February. So we wanted to see how March came in.

And unfortunately, when March came in, which the final accumulation of data came in mid- to late April, we knew we had to make changes. And so I think we had a final data set that we were able to act on, on a Friday, and we worked over the weekend and had the new business rules out to the partners Sunday night.

So we make -- we try to make decisions based on trends and not data points, and that's what we did in this case. We worked as quickly as possible to get those changes in place. And I think going forward, we should see much better improvement on pricing for the product, especially in the case of some of these covered scripts that we've been talking about.

And our next question will come from Mayank Mamtani with B. Riley Securities.

Regarding the 100 reps hired in a relatively short period of time, Mark, could you touch on what sort of experience they bring in and how you anticipate demand to inflect further as a result of that in the second half? And I don't know if I heard a commercial mix of the total NRx that you're seeing. If you could maybe give a little bit more color on also how these reps can have an impact on improving commercial mix? And I think in prepared remarks, Mark, you said there are some positive insurance reimbursement developments for VEVYE, if you could maybe lay that out in this 12- to 18-month period?

Pat, do you want to talk about the tenure of some of these new reps?

Thanks, Mark. Thanks for the question. As we talked about, this is all about demand and the indicators that we're seeing are very positive. And as Mark mentioned in the letter and previously on the call, we were able to deliver in Q1 the growth with a generally small team of 50 representatives. What we're most excited about in our expansion is the recruitment approach that we use. We have -- many, many reps we recruited have ophthalmic experience in their exact areas. I think we have a range of experience on the anterior side that I think is going to position us well for many of the other competitors in our space right now as we sit today.

So we're super excited about that team that's been out there, arguably a few weeks as it sits right now. And as Mark mentioned, our early indicators in Q2, we're showing positive signs, and we are just getting started. So I would expect ongoing growth acceleration because of the unique profile we have.

Our representatives are out there. I think, as Mark mentioned, in Q1, we wanted to get them out as soon as possible, but I can tell you that we took a very diligent approach to make sure that we've recruited the right reps, at the same time put them through a very rigorous approach to make sure that they were stepping the field to make impact immediately to grow VEVYE and the signs are very positive for us at this point in time.

And like I said, I mean, we're super encouraged on the prospect for growth going forward. And the team, as we've said, has been out there for only a few weeks. So I think more to follow here in Q2 about the progress they make with their customers. But early signs, expect more growth.

And Mayank, in terms of how do you improve the commercial mix, one of the things I like most about Pat is he really believes in incentives very strongly, and he buys into this whole concept of what you incentivize, you end up getting. And so we value a commercial covered prescription in our company, certainly more than we do, for example, a cash pay consignment prescription in terms of the economic value. And so Pat is a big supporter of that.

In terms of new insurance reimbursement, new coverage, the team is actively bidding on that coverage and those processes are in place. And we have some idea, that we should see improved coverage over the next 12 to 18 months. I think that's why we made the statement. We can't get more specific with which benefit managers or which payers. But we do believe that we're going to have some decent coverage wins over the next 12 to 18 months, and we'll see -- And to the extent that they're meaningful, we'll certainly make our stockholders aware of those.

Great. And then on the IHEEZO growth catalyst for second half, I appreciate the color on which ones are demand versus net pricing improvement related. But I was just trying to understand the full year revenue target for that brand because second half revenue uplift needed to get to the full year target. If you just look outside of VEVYE and compounding business, there's a lot of growth, including from IHEEZO and other products. If you could maybe just help us understand how do you get to the second half number throughout the different parts of your portfolio? That would be very helpful.

Yes. I'll ask Andrew to kind of give some additional color on that. But what I can tell you is that even in the second quarter number for IHEEZO in particular, you're not going to see the same level of revenue, we believe, for the second quarter as you did, for example, in the first quarter. So we do expect to see a meaningful step-up in terms of revenue from IHEEZO even in the second quarter and the big improvement to not only unit demand -- the big conversion of unit demand to revenue is going to happen in the third and fourth quarter for that product.

Andrew, do you want to comment on second half revenue and the guide?

Yes. I will. Mayank, so I think in the second half, number one, you also get a new product, which is BYOOVIZ coming to market, which we expect to have, let's say, a meaningful contribution to revenue. IHEEZO we expect from a revenue perspective to be close to last year's number, hopefully in excess of it from a revenue standpoint, depending on demand. VEVYE revenue will continue to ramp quarter-over-quarter, we expect. Hopefully seeing a meaningful improvement in Q2 over Q1.

And then in the second half of the year, we really -- we expect to really see the benefit of that sales force expansion, accelerating unit volumes and importantly, net pricing being stabilized on the product.

And then as Pat kind of mentioned, we should also start seeing contribution from some of these other products that are going to get some attention this year, VERKAZIA, NATACYN and then as well as IOPIDINE with the J-code being issued. And then we've got Imprimis on the compounding side and the Access+ side. That business has been sort of out of that inventory issue that had been occurring in Q4 and Q1 of this year, and that business should return to a growth trajectory this year, although more sequentially quarter-over-quarter versus year-over-year.

And the next question comes from Thomas Flaten with Lake Street Capital Markets.

Just to confirm on the sales force expansion. So in your letter, you talked about hiring about a 100 folks. If I'm understanding, 50 of them went to the VEVYE sales team to effectively double that team. And the distribution of the balance of those new hires, was it all to the retina team? Or was there -- is there something else we should understand about that?

No. And thank you for that question, and I'm glad that I have the chance to clarify. So we did hire about 50 new reps for the dry eye team. We also tripled the sales force for TRIESENCE, so that sales organization is now 3 times the size that it once was.

We've also made a few incremental hires in retina. And as I said, I think in my prepared remarks, we've also begun to -- we decided to bolster some of the Access+ team. So -- and then finally, VERKAZIA and NATACYN, in particular, historically have not had any inventory. They've had inventory problems with that product, and I'm talking about pre-Harrow ownership. It had not really had any dedicated sales and promotion.

And frankly, with both VERKAZIA and NATACYN, once again, the -- any marketing that was done was really done on only part of the label. So we're going to make a big push with those products. We're going to talk a little bit more about VERKAZIA in the coming weeks. I'm particularly very excited about VERKAZIA. We have great pricing on that product. It's a very powerful product in terms of its clinical efficacy and the results that it provides, particularly for children. It's the only cyclosporine that's actually on label for pediatrics. And we're going to make a big push in that category. And so we did build out what we call a specialty team around both of those products, and that team makes up the balance of that 100.

That's super helpful. And then, Mark, previously, I think you've mentioned -- I want to say you used the word bounty for pulling the G-MELT submission into 2026. I heard early 2027 today. I'm just curious if there was a chance that, that could get pulled forward if we should really think about an early '27 NDA submission for G-MELT?

Right now, I think -- let's think about a Q1 2027 submission. We're working really hard. I know the team is to complete the balance of the data gathering and to build the dossier for submission. So I think by our next conference call, we'll have a lot more information, and I'll be able to, I think, specify as to whether or not we'll be able to get a submission made at the end of the year. If we did, it would be at the very, very end of the year.

But I have to tell you, whether we make the submission in late December or early January or even early February, the potential that we see for that product is just extraordinary, absolutely extraordinary. And I do believe in due course that, that product will be perhaps our largest selling product by revenue. So we're really excited to get that NDA filed. All the really difficult risky work is behind us.

The work that Amir discussed is, I don't want to say perfunctory, but it is ultra-low-risk data gathering. And we're excited to meet with the FDA in a pre-NDA meeting. We'll have more information about that in August when we have our next call.

And the next question will come from Yi Chen with H.C. Wainwright.

Could you comment on whether BYQLOVI has already been launched and whether your current full year revenue guidance including -- includes sales of BYQLOVI and BYOOVIZ?

Thank you, Yi. The BYQLOVI launch, strictly speaking, when we say launch, we mean trade launch. We mean actual sales of the product. Believe it or not, from a sampling perspective, BYQLOVI is actually launched. We've begun to distribute BYQLOVI samples to select customers. I think there are several thousand of those samples out. We're going to spend the next couple of months continuing that process of sampling and talking to customers about BYQLOVI, which we think is a best-in-class topical steroid. The topical steroid category is a very large category.

And we're going to begin the trade portion of the launch, actually selling the product, driving revenue. That will begin in the third quarter. But strictly speaking, if you were to go into the offices of some of these doctors that are a part of this program, they will have access to BYQLOVI right now.

So samples are out, trade is going to begin in the third quarter of this year. And in terms of the numbers that we're quoting, they are inclusive of BYQLOVI for sure.

Okay. Can you also comment on how much contribution do you expect these 2 drugs to make in -- beyond 2026?

Yes. So we're not giving revenue-specific guidance on each product. Especially in a new launch, I think that would -- we would have a tough time doing that externally. We certainly have internally a model built, but we're not prepared with either BYQLOVI or even BYOOVIZ at this point to provide what the expected revenue contribution will be for this year or next year.

I show no further questions at this time. I would now like to turn the call back over to Mark for closing remarks.

Thank you, operator, and thank you all for joining us today. Let me close with what matters most, and that is Harrow's demand strength is stable. It's a foundation that supports my confidence in our future.

With the high deductible season now behind us, we're moving into a period of accelerating growth and execution. The first quarter included a discrete issue that we have resolved, and that does not impact the long-term trajectory of this business.

We spent the past several years building this platform, expanding access, scaling our commercial organization, and positioning our portfolio for growth. That work is largely behind us. We're now entering a period where the foundation translates into sustained revenue growth and increasing profitability.

Looking ahead, we have clear visibility into the drivers of our performance from improving access and pricing to new product contributions and clinical milestones. Beyond that, we're actively shaping our next 5-year strategic plan with a clear path to scale our core assets, unlock additional value across the portfolio and hopefully complete some accretive and exciting acquisitions.

When I step back, this is a stronger, more scalable and in my view, a more valuable company than at any point in our history. And we truly appreciate your continued trust and support.

Thank you, and this will conclude our call.

This concludes today's conference call. Thank you for participating, and you may now disconnect.

Good day, and welcome to the Harrow Fourth Quarter 2025 Earnings Conference Call. [Operator Instructions] Please note that this call may be recorded.

I would now like to turn the call over to Mike Biega, Vice President, Investor Relations and Communications. Please go ahead.

Good morning, and welcome to Harrow's Fourth Quarter and Full Year 2025 Earnings Conference Call. My name is Mike Biega, Vice President of Investor Relations and Communications, and I'm excited to be introducing today's call.

The company's remarks may include forward-looking statements within the meaning of federal securities laws. Forward-looking statements are subject to numerous risks and uncertainties and many of which are beyond Harrow's control, including risks and uncertainties described in time to time in its SEC filings, such as the risks and uncertainties related to the company's ability to make commercially available its FDA-approved products and compounded formulations and technologies and FDA approval of certain drug candidates in a timely manner or at all. For a list and description of those risks and uncertainties, please see the Risk Factors section of the company's most recent annual report on Form 10-K filed with the Securities and Exchange Commission. Harrow's results may differ materially from those projected. Harrow disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise. This conference call contains time-sensitive information and is accurate only as of today.

Joining me on today's call are Mark Bong, Chief Executive Officer; Andrew Boll, President and Chief Financial Officer; Patrick Sullivan, Chief Commercial Officer; and Amir Shojaei, Chief Scientific Officer.

With that, I would like to turn the call over to Mark. Mark?

Good morning, and thank you for joining us. Over the past 5 years, Harrow has undergone a fundamental transformation. Harrow now owns 1 of the largest portfolios of prescription ophthalmic products in the United States market. And we have been the most prolific acquirer of ophthalmic products in the U.S. market, having completed more than a half a dozen transactions, integrating over 15 branded products into our scalable commercial platform that reaches every populated county within the United States and touches with impact nearly every key ophthalmic disease segment.

As you'll note, in my letter to stockholders, I am proud of the fact that during the last 5 years, hundreds of members of the Harrow family, including my incredible leadership team drove real economic accomplishment and stockholder value creation, which resulted in a more than 70% appreciation in the Hero stock price during this period. As a founder and a large Harrow shareholder, I am proud of our track record and the returns we are providing to stockholders who have had the patience to let this team do its thing. But this team isn't done. And frankly, we've only just begun. I can't guarantee where our stock price will be 5 years from now. However, I can say with nearly absolute certainty that Harrow will be a larger and more powerful enterprise positively impacting the lives of millions of Americans. I resolutely believe that then we will be selling more of every 1 of our key products like Vevye, IHEEZO and Triescence. But I predict we will also sell many more units of other products that many stockholders haven't thought too much about. I also predict that we will complete compelling new acquisitions of products and/or businesses structured to appropriately balance risk and potential reward.

And finally, I can say confidently that 1 or 2 product candidates from our recent Melt Pharmaceuticals acquisition, specifically what we are now calling G-Melt and YOCHIL will be approved for marketing and that if they are coded and reimbursed in the way that we expect, they will make massive improvements to the standard of care in ocular surgery and more generally in the lives of so many Americans in need of an alternative to IV and opioid-based medicaments for sedation and anxiety. It's a very large market. And of course, these assets, as I reflected in my letter to stockholders should, in due course, become our largest revenue products. My bet is that if we do all of that and maybe even a little bit more, patient stockholders should be handsomely rewarded. I invite you to join me for the ride, because our best days are absolutely ahead of us.

Now let me provide a bit of color on our business as things stand today. We are entering the final phase of our current 5-year plan, and we are doing so with momentum. The portfolio we've assembled, the pipeline we've advanced and the commercial infrastructure we've built were designed for scale. This is not a single product company or a single product story. We are meaningfully diversified and our commercial platform is built for durability operating leverage and sustained growth. Today, Harrow operates as 1 Harrow, 1 strategy, 1 commercial engine, 1 unified organization. We have constructed a diversified ophthalmic franchise focused on expanding patient access, improving affordability and delivering strong clinical outcomes.

In the fourth quarter of 2025, we saw a clear validation of that strategy. For the first time, all of our core growth drivers accelerated simultaneously. That alignment reinforces our confidence and supports our goal of exceeding $250 million in quarterly revenue by the end of 2027. And financially, 2025 was a strong year. We delivered great top line growth and demonstrated operating leverage, underscoring the earnings power embedded in our model as revenue scales.

Let me briefly highlight some of the key drivers. Vevye is positioned for revenue acceleration and increasing new prescription velocity, expanded payer coverage is now in effect. So we are doubling the Vevye sales force to ensure that we fully capture the opportunity to build a product with peak sales potential of multiples of last year's numbers. More sales professionals will equal more prescriptions, and this should correlate to increasing profitable revenue growth. Our data backs this up, with covered patients averaging approximately 9 refills annually, effectively a full year of therapy. This reinforces the durability of the demand for Vevye. As access continues to expand and commercial intensity increases, we expect total prescription growth to continue this year and for many years to come as Vevye finally becomes a 9-figure revenue product this year.

IHEEZO delivered a record quarter, driven by real traction and a growing number of retina specialist offices. We have broadened our addressable market by focusing on in-office procedures, effectively increasing our procedure volume TAM by more than 2.5 million units annually. We're also expecting IHEEZO price improvements to begin in the second half of this year as we release a new retina-focused packaging format. At around the same time, we expect retina specific data readouts from studies underway to show from a patient's perspective, the difference between IHEEZO and legacy anesthesia modalities. This is only going to help us, we believe. We've got to see what the data says. These 2026 activities should further enhance financial performance and with multiple growth levers now in place, IHEEZO represents a durable and critical part of our long-term strategy.

Triesence generated its strongest quarter since relaunch, reflecting accelerating adoption in the very large ocular inflammation market. Based on what I'm seeing this quarter with new account trials starting in numerous potentially very large accounts and growing confidence in market access, I have asked our talent team to at least double the dedicated Triesence sales force to deepen penetration in what remains a very large market. Momentum here is early, but it looks meaningful. And because of the origin of the revenue, it is likely highly sustainable. It's not easy to get a product like Triesence added to a surgical treatment protocol. But once you do, and I have seen this happen many times over the years. If the product delivers exceptional outcomes as Triesence appears to be doing, then surgeons are often reticent to change, this is what I mean by the sustainability of the Triesence momentum.

On a related topic, for years, I've spoken about tracking the migration of elite sales representatives. This is nearly a surefire leading indicator of future success. You see sales reps go where they can win where they can make money and provide for themselves and their families. Well, the word is getting out, the Trieste is on the move. These elite reps from around the country are hearing about our commitment to this product and they know they will also be selling the G-Melt too if they can make it on to our team. A lot of folks want to get in on the G-Melt, believe me. So we are seeing a mushrooming inbound interest from some of the most prolific ocular surgery pharmaceutical representatives who want to take these coveted surgical physicians at Harrow on the Triesence team. This is really good news.

Now onto our rare specialty and compounded products. Behind the scenes, believe it or not, we've been planning a few positive surprises for our stockholders from the part of our portfolio, they would probably at least expect, yes, are rare specialty and compounded products. This portfolio is now under new sales leadership and it will benefit from new resources we are providing to finally bring out the value we expect from this exciting and unique group of products. As I discuss more in my letter to stockholders, there are 3 products from within this portfolio that our team has been quietly doing great work on. One product is awaiting a coding decision from CMS which we expect in April. There are no guarantees. But if this comes through next month, it will open up a very nice, attractive market for this product.

Regarding another product in this portfolio, we have a key study underway that we expect to read out later this year. Our entire team is super excited about this opportunity. This is a big one. And based on what we know about this product, we expect the study to be able to highlight the opportunity that we have uncovered and once the data is announced, it should fuel opening up, as I said, a very sizable and compelling market for this product. In fact, we are also simultaneously working out supply chain issues to ensure that if things work out the way we expect that we'll be able to supply the market adequately given the historically lower volumes that this product has required.

And there is a third product that we expect to be revived from this portfolio to also fill yet another nice but happens to be a smaller market opportunity, but a good 1 nevertheless. The bottom line is that I believe our stockholders may be positively surprised throughout the year and into next year as our plans for this portfolio are revealed.

A few final points. In 2026, we will also launch 2 important products by close and Bovis further expanding our retina and specialty footprint and leveraging our commercial platform. beyond commercialization, our pipeline continues to advance, and Amir will shortly speak about the great work he and his team are doing.

In summary, Harrow is a diversified ophthalmic platform with multiple accelerating growth drivers and increasing operating leverage we have demonstrated the ability to build, integrate and grow and generate a heck of a great return for our patient stockholders as our 5-year track record demonstrates. But as I said at the outset, I really believe that we are still in the early innings of our growth and stockholder value creation story.

With that said, I will turn it over to Andrew. Andrew?

Good morning, everyone. I'll begin with our fourth quarter and full year 2025 financial results. For the fourth quarter of 2025, consolidated revenues were $89.1 million, representing 33% year-over-year growth. For the full year, revenue was $272 million, up 36% versus 2024. A reflected continued strength across our brand portfolio and expanding commercial execution, particularly in the second half of the year. Adjusted EBITDA was $24.2 million in Q4 and $61.9 million for the full year, reflecting 54% year-over-year growth. This margin expansion demonstrates the operating leverage in our model as revenue scales faster than costs even as we continue investing in commercialization and R&D. In addition, during 2025, we generated just under $44 million of cash from operations, which helped us end the year with $72.9 million in cash and cash equivalents. Overall, 2025 was a year of strong execution, improving profitability and disciplined capital allocation.

Moving on to our core growth drivers. Starting with Vevye, Fourth quarter revenues were $25.9 million, up 14% sequentially, bringing full year revenue to $88.7 million, a 21% increase over 2024. Growth reflects expanding demand. IHEEZO generated $35.9 million in Q4 and $81.3 million for the full year, representing 64% quarter-over-quarter growth and 65% year-over-year growth. Performance was driven by increasing penetration across new and existing accounts, particularly in retina. Based on the momentum we are seeing with Triesence and other modest investments we intend to make in this franchise. We are disclosing this revenue separately for the first time. Brian's fourth quarter revenue was $5.1 million, a 36% increase from the third quarter, totaling $9.9 million for the year, a 193% increase in 2024. The growth was primarily driven by accelerating adoption of Triesence [indiscernible]. Our rare specialty and compounded portfolio generated $22.2 million in Q4 and $92.3 million for the full year. The temporary compounding inventory constraint discussed last quarter is expected to be resolved in the coming weeks, and we expect inventory levels to normalize near the end of the first quarter. We do not anticipate a recurrence [indiscernible].

For 2026, we are approaching guidance with greater transparency and structure and are committed to providing greater insight into the seasonality of our business and how we expect performance to build throughout the year. We expect full year 2026 revenue between $350 million and $365 million. For modeling purposes, we currently expect first half revenue in the range of $133 million to $153 million and the second half revenue in the range of $203 million to $226 million, reflecting the expected phasing of demand channel dynamics and launch timing across the year.

Adjusted EBITDA is expected to be between $80 million to $100 million for the full year with the majority of the EBITDA generated in the second half of 2026. As in prior years, the second half is expected to be stronger with that weighting being more pronounced in 2026.

Historically, quarterly revenue patterns have been consistent, though 2026 will be slightly more second half weighted. Like the past 2 years, the first quarter is expected to be our lowest revenue quarter. primarily due to stocking activity from the fourth quarter and insurance resets and a higher concentration of high deductible plans. We estimated fourth quarter demand for IHEEZO resulted in approximately 1.5 quarters of incremental inventory being built across the channel. That inventory is expected to be drawn down largely during Q1. As a result, although we are seeing demand grow for IHEEZO similar to the first quarter of 2025, because we are drawing down on Q4 2025 inventory that's in the channel, we do not anticipate meaningful IHEEZO revenue in the first quarter.

Vevye entered the year with expanded coverage effective January 1. While we expect improved access will increasingly drive prescription growth throughout the year, the first quarter typically reflects an increased mix of high deductible plans, which creates near-term pressure for Vevye and our branded portfolio. The financial impact of the coverage in will start to be more pronounced as the year progresses and once our expanded sales force is fully deployed. We typically operate with a disciplined methodical approach to spend and we have done that for a reason to protect profitability, drive ROI and preserve strong cash flow. This year, however, we see a clear opportunity to maintain that discipline while increasing the pace and level of investment to expand our revenue base for years to come. As a result, we expect SG&A to increase to approximately $185 million to $205 million in the year as we expand our sales force across our major products and categories, including Vevye and Triesence and prepared to support the launches of BYOOVIZ and BYQLOVI. We plan to add roughly 100 new sales roles in the first half of the year, and we will pair that with increased promotional and marketing investment to drive awareness, adoption and sustained growth in the back half of the year and into 2027. Importantly, even as we invest, we will continue to manage expenses with a careful eye toward profitability and cash flow, holding orals accountable to returns and managing the spend accordingly. We also expect R&D expenses to increase this year to approximately $30 million to $35 million as we complete studies required for the Melt product candidates, NDA submissions and as we invest in post-market studies that Amir will discuss later, efforts we believe can support near- and long-term growth across key products.

Looking to the second quarter, we expect IHEEZO will reuse pass-through status effective April 1, impacting the ASC market. Approximately 30% of 225 units were generated in the ASC setting. We've been preparing for this transition through our retina pivot in 2024 and the recently announced in-office expansion strategy, which, as Mark said, added about 2.5 million annual procedures per TAM. The continued growth in retina and in-office utilization is expected to offset and ultimately exceed the ASC impact. We also plan to launch by clove in Q2, which will support incremental growth in our specialty portfolio.

Now looking at the third quarter. We typically experienced some late summer softness due to both doctors, staff and patient score vacations. The third quarter will include the first full quarter of BYOOVIZ revenue contribution which should provide incremental growth. We are anticipating that IHEEZO will also catch some of the additional tailwinds as a complementing product to BYOOVIZ. In addition, beginning in the third quarter, we expect to start to see the impact of our expanded and fully deployed Viva and tries in sales force, driving growth for both products. Also starting in the third quarter, we're expecting a pricing improvement for IHEEZO to go into effect. When you combine that with the continued revenue growth in the in-office expansion, we expect IHEEZO to have a strong second half of 2026 and position us very well for 2027. The fourth quarter should remain our strongest quarter, driven by demand patterns, stocking activity and patients reaching power pocket maximums.

Finally, as Mark discussed in his letter, as we intentionally transition compounded volume to FDA-approved branded alternatives, 15 revenue into our specialty portfolio, we expect compounded revenues to be approximately $60 million to $65 million for the full year with Q1 the softest quarter as we exit the final stages of the inventory shortage.

In summary, we expect a softer first half as we work through channel inventory absorbs the ASC transition and navigate seasonal deductible dynamics. In the second half, we expect a meaningful acceleration driven by a fully deployed Vevye interactive sales force, contributions from BYOOVIZ and BYQLOVI, improved IHEEZO pricing, expanding retina and in office adoption and incremental contribution from specialty products.

Now I'll turn the call over to Pat Sullivan.

Thank you, Andrew. Starting with Vevye, we exited 2025 with strong fourth quarter momentum at a clear inflection point as expanded coverage went live. Despite limited coverage throughout 2025, we delivered a 115% increase in prescribers writing Vevye, underscoring strong underlying demand for the product, but there is so much more opportunity for Vevye growth in a large and growing U.S. dry eye category.

With broader coverage now in place for our sales force expansion underway, we expect prescriber growth to continue. Consistent with the data shared in 2024, covered patients averaged approximately 9 refills in 2025, effectively a full year of therapy. That level of persistence underscores Vevye's differentiated clinical profile rapid onset, sustained efficacy and comfortable on-eye experience without the stinging and burning commonly associated with other treatments. The bottom line, though, is that we do not believe that any product in the category has this level of refill persistence. Since coverage expansion began, we have seen acceleration in new prescription trends despite navigating a challenging period with insurance benefits resetting and high deductible plans, and we expect continued improvement as the year progresses.

To fully capitalize on this opportunity, we remain on track to double the Vevye sales force by Memorial Day, expanding our Vevye presence among eye care professionals to drive higher prescription volume through 2026.

Turning to IHEEZO. This product materially outperformed our expectations in 2025. And with an impressive 56% growth in unit demand year-over-year. Growth was driven by our expansion in the new retina practices and deeper utilization within existing accounts. Ordering accounts increased 49% year-over-year and retina Specials represented approximately 70% of fourth quarter unit volume, underscoring where adoption and clinical traction are strongest. Importantly, we believe we are still in the early innings of penetration with significant untapped market opportunity ahead as we continue to expand utilization and drive broader adoption.

Looking ahead, in the second half of 2026, we expect a net price improvement, which we expect will further enhance the products revenue and overall financial profile. Importantly, this comes as we prepare to launch BYOOVIZ in mid-2026 further accelerating IHEEZO's expansion into new retina accounts while deepening penetration within our existing customer base. We are also expanding IHEEZO into the office-based setting to broad utilization beyond retina. This initiative targets more than 2.5 million anesthesia relevant procedures that already benefit from established reimbursement pathways, reducing access friction. Earlier engagement has been encouraging, supported by a dedicated commercial effort and our existing relationship in the office space channel.

Turning to Triesence. We delivered a record quarter driven by accelerating momentum in ocular inflammation and continued strength in retina. Despite formally launching in market on October 1, we saw a good portion of the Q4 unit volume come from ocular surgery accounts. and we expect this large market will drive the majority of new volume going forward. Nearly half of the fourth quarter ordering accounts were new and helped drive quarter-over-quarter growth in unit volume. To extend this trajectory, we are in the process of doubling the dedicated Triesence sales force. Based on current trends, we see substantial runway for continued growth in 2026 and beyond.

Finally, our rare specialty and compounded portfolio performance rebounded in the fourth quarter as new commercial leadership took hold and execution improved. While we are encouraged by that momentum, I believe there is substantial room to grow this portfolio of everyday workhorse products from current share levels. We are implementing several revenue-generating initiatives tied to these assets, which we expect to detail later this year. In parallel, as Mark discussed in his letter, we are focused on converting compounded utilization into FDA-approved branded products through the launch of Pharmapack Max and Pharmapack Prime, further strengthening the long-term revenue profile of this segment.

In closing, each of our core growth drivers accelerated in the fourth quarter, and we entered 2026 with clear commercial momentum. We are scaling the organization to support the trajectory doubling the sales forces behind Vevye and Triesence, expanding IHEEZO into the office space setting and preparing for important launches this year with strengthened infrastructure, expanding access and a diversified ophthalmic portfolio, we believe we are well positioned to drive sustained growth and delivering increased value to patients and shareholders.

With that, I'll turn it over to Amir.

Thanks, Pat. I'd like to turn to our pipeline, which we believe represents a compelling long-term value driver for Harrow. The next phase of growth is highly focused and capital efficient. We're advancing clinically relevant programs aligned with clear unmet needs in ophthalmology and tightly integrated with our commercial infrastructure and regulatory expertise. While there are several programs on this slide, and more that you don't know about yet. I'm only going to focus today on G-Melt, formerly known as MELT-300 and the ongoing IHEEZO studies. G-Melt exemplifies our strategy. It is a fully opioid-free and IV sparing procedural sedation candidate that has the potential to redefine that standard of care, and I believe has the potential to become our largest product.

Today, procedural sedation often requires IV access and uses opioid-based regimens, introducing complexity, staffing burden, monitoring requirements and longer recovery times. G-Melt has the potential to simplify that model. From a development perspective, we initiated the remaining pharmacokinetic work earlier this year and are advancing CMC activities with our CDMO partner. We remain on track for an NDA submission in early 2027, while continuing to evaluate opportunities to accelerate time lines. We view G-Melt as platform-level upside, a differentiated sedation solution with the potential to broadly improve procedural efficiency and create meaningful long-term value in the ophthalmic market and eventually beyond. Pipeline value also comes from expanding the evidence base for marketed products, including IHEEZO. I'm amazed that our team has been so successful with IHEEZO and retina given its supporting data was in cataract surgery. And now for my experience developing back-of-the-eye product that retina professionals who are the primary users of IHEEZO want to see specific data based on procedures they need IHEEZO 4, namely intravitreal injections. Therefore, we are investing in clinical data generation to support adoption, strengthen differentiation and reinforce long-term positioning with both clinicians and payers.

While this slide highlights IHEEZO's similar work is underway across the portfolio. High-quality evidence builds clinical confidence drives utilization and supports sustained reinvestment in the franchise. For IHEEZO, we are sponsoring multiple complementary studies an intravitreal injection procedures. The first and most near-term data is an investigator-initiated randomized trial led by Dr. Samin Dang comparing IHEEZO to standard anesthetic approaches, evaluating pain and ocular symptoms with data expected at ASRS this year in July. You could see the quote he provided us with on the bottom left of the slide. As for our own Harrow sponsored IHEEZO study, my team has put together a Phase II multicenter randomized trial assessing patient reported pain and safety across approximately 240 patients. We initiated the study in the first quarter of 2026 under the IND and expect to have data available by the end of 2026.

Together, these studies are designed to generate clinically meaningful practice relevant evidence that supports further and more broad-based adoption reinforcing AES as a durable long-term growth driver.

In summary, Harrow's pipeline is focused, efficient and impactful. It complements our commercial momentum, expands our addressable market and creates multiple pathways for long-term value creation. We are building not just individual products, but a sustainable innovation engine that positions Harrow for continued growth.

With that, I'll turn it over for questions.

[Operator Instructions] Our first question comes from Chase Knickerbocker with Craig-Hallum.

Appreciate the candid thoughts as in the shareholder letter. So Mark, you kind of mentioned in the letter that you expect kind of continued commercial growth and commercial mix improvement for Vevye kind of through the year. What have you seen so far from a commercial mix perspective in Q1? And then can you walk us through what your ASP assumptions or direction of ASP for Vevye is in the 2026 guide kind of versus volume?

Yes. So regarding ASP, I think the only -- I'll answer the second question first. On ASP and net pricing, but the only comment that we've made and that we intend to make is regarding the buoyancy and the slight uptick in ASP, which I had forecasted probably a quarter or 2 late. But nevertheless, as I said in the letter to stockholders, we saw that direction of travel, and we eventually got there. So with a more sustainable and buoyant net pricing for Vevye, that coupled with some of the things that we're seeing on the commercial side with this new coverage, we have initiated this program to more than double the Vevye sales force.

In terms of the build and what we're seeing on the ground today for Vevye. As I said also in the letter to stockholders, even in the fourth quarter, we started to see a little bit of momentum build. I think I've said in the past that CVS had actually sent out letters to thousands and thousands of eye care professionals around the United States, alerting them to the new positioning, the preferred positioning for Buy on their formulary. And that alone, I think, began the positive momentum that we're also seeing a little bit in the first quarter.

What I can say regarding the first quarter is that typically, it's a weaker period. And we're quite surprised with the new prescription volumes that we're seeing today relative to what we thought we would see, which is to say that the new prescription volumes are meaningfully better than what we thought we would be receiving at this point in the year. So we expect that to build throughout the year. As I said in my prepared remarks, we have data that demonstrates very clearly that more reps in the field for this particular product, given the persistence of the product and the market interest in the product yields more prescriptions. And for us, building those new prescriptions ultimately leads to more and more total prescriptions and more revenue. So we're very much bent towards building volume in Vevye, and that's how we're set up for this year, and that's what you should expect.

Helpful, Mark. And just for my second question, another multiparter, sorry, but just on the Triesence Phase III and cataract announced this morning. obviously, a large potential volume opportunity. Just a couple of questions to help us understand the magnitude. So what percentage of the cataract market do you think is kind of the sweet spot for Triesence as it relates to kind of the value prop versus the multi-drop regimens that are pretty pervasive today? How should investors kind of think about the TAM expansion from this label expansion kind of within cataract for trace?

And then second, I think investors often have kind of question on duration of opportunity with pass-through products in ASC. Can you just remind us or discuss the unique aspects of Triesence that may allow for longer-term payment outside the bundle or how you plan to approach pricing there?

Sure. Once again, I'll take the second question, the second part first. In terms of reimbursement for the product, Triesence is a very unique label in that it is both used in the office setting of care, and it's also used in the hospital and outpatient department setting of care. And as a result of that, and I don't want to go into the nuances of of reimbursement policy, but we believe that is will not be limited by a TPT or a temporary pass-through period. And regarding the first part of the question in terms of what the TAM expansion might be for this study that Amir just received clearance on, I believe, yesterday. I go back to, I think, another comment that I made in my prepared remarks and that is that our vision for cataract surgery is that in the future, patients in the United States should have an IV free opioid free and even an eye drop free procedure. That is what I would want my mother to have. That's what I would want anyone that I love to have, not to have to put eyedrops in their eye multiple times per day, multiple different eye drop bottles that's assuming you're using an FDA-approved product, of course. And so that should be the ideal, and that's what we're working towards. That's what the G-Melt is about and that's what this expansion with Triesence is about. It's about putting power in the hands of the surgeon to deliver the anti-inflammatory into the eye so that the patient doesn't need to administer these post-surgical eye drops. What's interesting is, anecdotally, what we see is that for patients who are using this on label which is a subsegment of the cataract surgery population. It's those patients who really can't administer eyedrops who have other comorbidities. What we decided to do because those patients are having such exceptional results is to invest in expanding the label so that all cataract surgery patients have access to this therapy. And what's terrific is, as I said, we've got reimbursement. We have an exceptional clinical outcome. And with this amazing study that Amir and his team are going to execute, we're going to have a very broad-based label that will finally give cataract surgeons access to an easy to administer highly efficacious post-cataract surgery anti-inflammatory that they themselves can inject. And here's the best thing for consumers, for patients. It has the lowest out-of-pocket of any injectable steroid at around $37 per unit. So it's affordable, it's accessible, it's highly efficacious, and we're going to invest for a very small amount of money in a study that will significantly expand the number of patients who will have access to it. And in the United States, by the time this data reads out, that should be about 5 million procedures annually. So it's a very large market opportunity. And as I've said for a couple of years, Triesence is a slow grower. We've got a lot to prove there for sure. But this is a product that in the next couple of years is going to be a meaningful value driver for our stockholders.

Our next question comes from Timur Ivannikov with Cantor Fitzgerald.

Yes. This is Timur Ivannikov on for Steve Seedhouse. So first, on IHEEZO, I think you mentioned price improvements in the second half of 2026. Could you clarify, is that a price improvement from Q2 '26 or from Q4 '25? And do you expect Q2 '26 ASP to be significantly lower?

Andrew, do you want to take that?

Yes. So and just to try to make sure I answer the question correctly. We expect by the time we get to Q3 of 2026, pricing for IHEEZO will be better than what it was in 2025 and in the first part of 2026.

Okay. Got it. And then second question is on the Triesence cataract trial design. Just wanted to understand the trial a little better. I think you mentioned the trial design versus placebo. Could you talk about the use of droplets anti-inflammatory eye droplets in both groups? I mean, are you allowed to dose the droplets in the treatment arm and the control arm?

Amir, can you handle that one?

Yes. I think the protocol design is pretty clear. We're going to have a control arm, which will not get Triesence. And then -- but we do have rescue criteria already built in and those risks it would allow drops again per protocol.

Our next question comes from Mayank Mamtani with B. Riley Securities.

I appreciate the helpful go-forward guidance framework. So by NRx improving and the commercial mix also improving, Mark. Are you able to share with us any end of year or second half loaded kind of market share targets that you may have. So we can understand the growth in the market, obviously, multiple companies investing here on the penetration side, but also I want to understand how you're thinking about share gains in both the cash pay and also, obviously, the commercial mix markets? And then I have a follow-up, with IHEEZO.

Sure. Yes. So we have 3 goals for Vevye. First of all, I just want to say that the dry eye market in the U.S. is, Pat said, a very large market. We believe it still continues to be underpenetrated. And we continue to see data that demonstrates that there are large segments of the dry eye patient population that are receiving products on a monthly basis that burn in steam cause pain, sneeze. I mean the list of these effects are too long. And so when we see that patients are getting access to these nonoptimal therapies, for whatever reason, whether it's coverage or they're just not aware of Vevye. We see that as opportunity to convert those patients to a therapy that doesn't burn and sting and that has all of the positive benefits that Vevye offers, including now these enhanced coverage metrics.

But in terms of what our goals are, to be clear, the first goal is we believe Vevye will be the #1 cyclosporine in the U.S. market cyclosporin is the most trusted active ingredient in the dry eye market, and we aim to be the #1 cyclosporin. Second to that, we believe we can capture the anti-inflammatory market. So any product that actually has an active ingredient and that would be an anti-inflammatory, and we believe all forms of dry eye disease we don't care which 1 you choose have an inflammatory component to them. And so we aim to be secondarily the #1 anti-inflammatory. And then eventually -- and it's not going to happen overnight. We think we have the opportunity with this particular product to be the #1 most prescribed dry eye product.

Now for the last couple of years, our competition has had a sales organization, even the most inferior products in the market have had much larger sales organizations than we've had. And we are now as I said, more than doubling our sales force. I think we're more than halfway there. So I'm actually surprised that talent team is doing a great job. And there's just a lot of people that want to join this Maria's team and sell Vevye. But in terms of specific market share percentages, we're not giving those goals. I think to be the #1 cyclosporin in the market we probably need to have just north of 20% market share. So that gives us a sense of what we think is achievable.

And by the way, in many markets, we are already there. The problem is, is that we touched historically, so few markets with a sales organization of just under 50 people that even if you have better than 20% market share in the Greater Cincinnati area, which happens to be the case. You -- there are many other markets where you just simply don't have that level of market share. So with this enhanced sales force now numbering close to about 100. We'll touch more markets. We will increase our market share, I believe, and we'll get closer and closer to that goal of being the #1 cyclosporin.

Pat, do you want to add to that at all?

Thanks, Mark. I think One of the things we're most optimistic about as we stated in our earnings is the increase in writing that we see, we saw 115% growth in our writing. And I think as Mark mentioned, the feedback that we received from our eye care professionals from their patients is extremely positive around the fact that Viva uniquely manages inflammation, how rapid it works and at the same time, is the unique tolerability profile. We are extremely encouraged that our next phase of expansion to cover a much larger portion of the market and increase Vevye presence to really grow this product to be the #1 cyclosporin. So Mark, we're well on our way to building our next phase of growth for Vevye.

And then on IHEEZO, obviously, a lot going on here, ASP past status expiration but also price per unit improvement that you mentioned. And there's also some data generation activity. You noted that ASRs conference middle of the year. I was just curious to contextualize its contribution to the guidance. Are you also thinking like Vevye, this is a 9-digit revenue contributor for this year? Or is it more a reasonable target for next year?

Yes, I don't want to comment on the revenues for that product. I think the only product we've given guidance on it specifically is Vevye, which is clearly on the road to 9 figures. What I will tell you is this, just as a reminder, in 2024, we had absolutely 0 retina presence. We didn't have a retina sales force. We didn't have any products in that market. And only a couple of years ago, did we hire that sales organization. So in really August of 2024, we began what we call the retina pivot where we were able to attract great people from much larger companies that had tremendous backgrounds in retina, and we've built this organization. I remember going to ASRS and Stockholm, nobody knew who Harrow was. They had we had no presence in that market, and it's a very tight community, the retina community. And what I can tell you is over the last 1.5 years, 2 years or so, I think if you go to retina professionals now and ask them if they know who Hero is they really know who Harrow is. I have to say another thing about IHEEZO specifically because it is amazing what Ali and her team have done, taking a product where the clinical studies supporting the NDA were in cataract surgery, and they have been able to adapt to that data to the intravitreal injection market now with more than 70% of the unit volume for IHEEZO in the retina market. What's really exciting is what Amir talked about with the DANG study.

What Ali has wanted for well over a year, we've had numerous conversations is specific data related to the performance of IHEEZO in the intravitreal injection procedure. And we had all this anecdotal information, doctors would tell us how it performed. Some doctors had other benefits that they experienced from the product, including efficiency and their workflow. But what I think you're going to see in the middle of the year, finally, for Ali and her team is a data set that will demonstrate the real difference between IHEEZO and these legacy modes of providing these patients with anesthesia for these intravitreal injections. And I have to tell you, if you're a patient getting these injections, the anesthesia and pain control really matters. And we think we have a product, at least anecdotally, we've received tremendous information from accounts that use this product about its performance. And in the middle of the year at ARS, and he got a late breaker, by the way. I mean it's not easy to get these, but he is going to present this data, and I think that is going to fuel significant demand in the retina market for this product.

So in terms of how we -- how IHEEZO fits into our overall guide this year and certainly in 2027, depending on how this data comes out, this is an opportunity, I think, to significantly improve the unit volume demand for IHEEZO. And then as Andrew said, that coupled with this new packaging format, but specifically for retina, and a meaningfully improved price. I think that by the end of next year, you're going to hopefully be surprised at what we think we can generate from this particular product.

And lastly, very quickly, the OpEx expansion that you have. You're seeing your R&D was higher in fourth quarter. Is it sort of a first half loaded kind of dynamic and is there a steady-state OpEx spend and what you're trying to get at some point this year?

Thank you, Mike. Andrew, do you want to tackle the OpEx?

Yes, absolutely. And I want to be sure to note in Q4, in the P&L, there's an $8.5 million charge for acquired in-process R&D, which was associated with the Melt acquisition, as the upfront costs and some of the transaction costs associated with the deal. But none of that acquisition cost was capitalized all ran through the P&L and then through R&D according to capital and we also didn't back it out or add it back in, I should say, to the EBITDA number for 2024. But kind of looking forward the adjusted EBITDA are looking forward at the OpEx spend and in kind of breaking into 2 parts. You've got the SG&A side, which we're adding that sales -- the sales heads right now. We've been adding them aggressively in Q1. We'll continue to add them in Q2. And then we've also been preparing. So we're preparing from a marketing and promotion standpoint, which is also increasing that spend we're trying to get ahead of a lot of that as well. So that when these people get hired and trained, they're hitting the ground running with Vevye and Triesence for that matter.

From an R&D perspective, a lot of that cost, as you know, are going to be trial dependent. You sort of have a base here of R&D spend year-over-year. But as we put out this announcement this morning regarding the true IND being accepted, and that's been picking up. Those costs will kind of show up in the middle part of the year, so Q2, Q3. So we'll have a little bit of a ramp in the middle part of the year and then it should come down a little bit on the R&D side in Q4 as you sort of wrap up those studies along with some of the Melt studies.

Our next question comes from Lachlan Hanbury-Brown with William Blair.

I guess, first, I would appreciate maybe a little more color on how you're thinking about the IHEEZO dynamics in 2026. So you said you think the in-office procedure expansion beyond retina can offset the ASC loss. Is that sort of specifically talking about Q2? Or is that more of a longer term you think looking a year or so out it will have more than offset that. So I guess, should we expect maybe a drop in Q2 in unit demand?

Yes. I don't want to be specific about demand in any particular quarter other than to say that in Q4, Q1, Q2, Q3, I think I've said this, we expect demand to continue to increase. So demand continues to increase. That's separate from revenue recognition. But demand for the product does continue to increase.

In terms of when we're likely to see the offset from the loss of the ASC units, when I looked at the ASC units specifically, the number of units that we're losing relative to the overall opportunity that we're adding when we add these in-office opportunities of this 2.5 million unit increase to our TAM, it's such a small level of success. And we have a discrete team going into the same customers that are using it in the they don't know that they can use it also in their clinics. Remember, every 1 of the doctors that's using it in the ASC is a surgeon, but they also only spend a day or 2 a week in the surgery operating, the surgical operator. The rest of the week, they spend in their office doing procedures. And so it's a simple idea, we're going to the same customers that are using the product satisfactorily in the ASC and we're saying, "Hey, you're doing more procedures in your office than you're doing in the surgical suite. And it's not for every procedure, but for those procedures where this could be impactful, we're going to the same customers and trying to convert their in-office business. And it's such a small number of units, as I said, that we don't have to really be that successful to fully offset the entirety of what we're losing when we lose the temporary pass-through code. So is that going to happen in the first quarter or the second quarter? No. I doubt it. It should happen throughout the year. And as I said, it's such a small number of units relative to what the overall opportunity is that we can fail and fail and fail again. and still end up eating up all of those lost units from the ASC.

That's good color. I guess second question is, just on Vevye and the new coverage. I'm just wondering what you see in terms of the patients that are sort of getting scripts filled under that coverage. Are they new to brand patients? Or is there a sizable chunk of them who previously paying cash pay or maybe you previously managed to get coverage for them who are now just converting to be sort of covered more easily.

I can't say specifically with numbers, what percentage or what number of patients are converting? What I can sort of echo what we've said in the past and that in 2025, there were a lot of patients who we received prescriptions for but legal prescriptions, but who are denied access to the product for 1 reason or another, who chose not to get their prescription filled. And so we're going out to those patients. Now those patients still have legal prescriptions, and we can contact them and make them aware of the existence of coverage and try to capture as many of those as possible. At the same time, they're or patients who are paying cash, as you said, so these consignment patients who do have coverage now, but formerly did not, and we can go to them. We know exactly who those folks are as well and convert them. This is a sizable number of people and you're talking about well north of $30 million new covered lives where you have the best access for Vevye now. So we have to see how things play out. I think based on what we're seeing in the first quarter, we thought we would not be where we are. We're in a better place than where we thought we would be in terms of new prescriptions. The new-to-brand side of things, I think, is going to come once we get these new bodies out these new sales reps, you'll have more and more of that new to brand. And I can say -- and I don't want to steal Pat's thunder. But Pat, do you want to actually talk about the whole new to brand? Because I know that's really been a focus of yours.

Yes. Thanks, Mark. And I think the core to our next phase of growth for Vevye is really around driving new growth for Vevye. We know better as possible when it comes to managing dry disease, as Mark mentioned. And our main focus going forward is ultimately to win the new-to-brand patients. And I think that's going to be a heavy focus for us and obviously the beginning of this year in our conversion from CBS. We are really in our expansion and leading up to our expansion, heavily focused on the right patient and working with our physicians, our communication approach to make sure that we are targeting these patients. Because what we do know is those that are having either coming in that are having dry disease symptoms or having unresolved or persistent symptoms on other suboptimal treatments. Vevye is the perfect treatment for that. Our goal moving forward is to make sure that we have the right presence with our customers and ultimately target the right patients going forward.

So Mark, to your point, a new to brand for us is a huge focus and will really start to come to life for us as we go to our next phase of expansion.

Our next question comes from Tom Shrader with BTIG.

Thanks for all the updates, fascinating time. On the Vevye sales force, after your increase, where does that put you relative to competitors like myBo, would you be on an equal playing field? And then just a remedial question on the Melt franchise, are you still wedded to 2 products? It seems like the first product is the bigger product. It's the combination. Does your compounding business inform you that there really is a need for 2 products?

Yes. So I'll take the first question. In terms of the Vevye sales force, I actually -- we don't know exactly how many reps these competitors have out in the field that we've heard that 1 of our competitors that has a pretty sizable market share, has upwards of 300 people. So we're going to have around 100 ourselves. But what I can tell you is that our reps are so powerful that 1 Harrow rep with Vevye is equal to 4 of theirs. I'm kidding. But we really do have a terrific sales organization that's well trained and they have an outstanding product to sell. We -- this is the second phase of our expansion. So this -- we had the initial hiring for this product. This is the second phase taking us up to around 100 territories or so. They very likely could be a slight increase in the number of territories as we see this investment pay off. And so -- but we're excited to have the sales force double more than doubling here in the near term. And I'm also pleased with the quality of people we've been able to attract and those that we've continued to retain who are on Maria's team.

In terms of Melt and the need for both products, the MKO Melt, which is a compounded formulation that we've sold for a number of years, is -- has really informed the entirety of the development program. One of the nice things about the melt when it is approved, is that we're going to discontinue the compounded version of the product, and we'll hopefully convert all of that business into an FDA-approved and hopefully, reimbursable product. It is very hard, as I've said, over the years, to sell compounded medications. They're not FDA-approved. They don't have a label, particularly in anesthesia and sedation where an anesthesia professional is going to take place or 3 times about whether or not they're going to use a compounded formulation. So when we have an on-label FDA-approved product that is also hopefully reimbursed, this should significantly expand the market opportunity for the G-Melt in cataract surgery, but also for other procedures where -- and a sublingual nonopioid sedation choice can prevail. In terms of why we need also the 210 program, the 210 program addresses a different market segment. And believe it or not, in terms of the total number of units of opportunity for it, based on the expected label and we still need to discuss that with the FDA and come to a resolution around what ultimately a label might look like for what is now called YOCHIL, that product in terms of unit demand is bigger in unit volume demand, we believe, than even the G-Melt. The G-Melt will be used certainly in cataract surgery, which is what we're studying it for. We also believe it will be used as the compounded product is used in ENT for endoscopy, it's used in dermatology, plastics, dental, widely used in dental, it's used to deal with claustrophobia and MRI tubes. And so that's the experience that we have with the MKO Melt, the compounded version. And our expectation is that the G-Melt when it's approved, eventually will be used in markets outside of ophthalmology, which happened to be even bigger markets than the ophthalmic market. But the answer is yes, we need 2 products. They serve different markets. One is specifically related to anxiety. And it will also, as I said, be available, and I said this, I think, in the letter to stockholders in 3 different ultimately be available in a number of different strengths.

If I can sneak in 1 follow-up. The new Triesence, I mean, it seems like it's a much easier product to make and now. Do you think you might expand that outside the eye where that steroid is used? Or is this entirely a formulation for the eye?

It's purely for the eye. It's -- we started our company in 2014, our first sale was with triamcinolone acetonide for injection. And this is a product category an active ingredient, we know really, really well. Our compounded formulation, once again, the enthusiasm for Triesence for us comes from our experience, having sold Trimax in well over 1 million cataract surgery. So it's a market we know well. It's just -- this product is just going to be for the eye, but we have real high hopes that we can once again create this protocol, which is IV free, opioid-free and even eye drop free eventually for cataract surgery patients, which is really where the market needs to go.

Our next question comes from Thomas Flaten with Lake Street Capital Markets.

Following up on Vevye, with respect to the sales force expansion, can you talk a little bit about -- and I think you alluded to this mark that it's a lot of new territory, but new territory versus territory splitting because of overload. And then how you see the dynamics between the ophthalmology and optometry community playing into that growth expectation?

Well, I'll take the second 1 first, and then I'll flip the first to Pat. But in terms of the sales force -- actually, pardon me. Right, your second sales force expansion and what else comes?

The ophthalmology versus optometry.

Yes. So ophthalmology and optometry, Believe it or not, the optometric market is a critical market. I would say that I would be slightly biased towards the optometric market. I think now optometrists are writing as many are probably more prescriptions for dry eye medications than ophthalmologists. That's what the data that I'm seeing shows. But Pat, do you want to talk about the sales force expansion specifically?

Yes. Thanks, Mark. And I think when we think about the expansion, I mean, this is a real great opportunity for us to look at the great progress that Vevye has done for broad disease patients to date. And I think 1 of the first things we do is look at this, to your point, you were talking about like basically business interruption versus business continuity. It sounded like your question was around I think we're taking a very methodical approach to make sure that we are on relooking at making sure that this approach going forward. It is sales force expansion, but it is about us brand presence and promotional efficiency in front of our customers going forward. This is a very, very active category that is large, growing and active. And for us, like to the prior question by 1 of your colleagues around playing in that dynamic part of the market where that new to brand is, it's going to take not only having our current territories be very efficient, but also our expansions. We are being very, very thoughtful in how we're on putting our footprint together. But I think the key takeaway here is Vevye is poised for significant growth going forward, but it will be about how we want to put a new Vivi presence in front of our customers that 1 is really about differentiation, new to brand and having the right presence that is commensurate with being a #1 goal of being #1 cyclosporin and #1 drive disease treatment. So to your question, very thoughtful on how we'll drive that business to maintain our aims and our growth going forward.

And just as a practical matter, look, we need to get salespeople in these offices. They need to see their Vevye reps more frequently. And that's what this is about. We know where the high-value targets are. We know who's prescribing dry eye disease. We know who is looking for dry eye disease, and this expansion is going to allow more Harrow Vevye reps to get in those offices far more frequently. And our data demonstrates very clearly that when we do that, we end up with more prescriptions for Vevye. And I think you're going to see that throughout the year.

And Mark, to follow up on the last commentary on Melt being used or MKO being used a lot outside of ophthalmology indications, what can we expect with respect to deal making to get melt appropriately exploited in those opportunities that are outside ophthalmology.

Well, right now, we are completely focused on 2 things. One is Amir and his team building this data set. I've put a bounty on him getting that NDA in sooner than he even thinks he's able to get it in. And I'm hopeful that we can hopefully we can beat some of these time lines that we've laid out. So it's all about getting the NDA in and getting the data in front of the FDA so that we can hopefully give this approved and then ultimately get it coded for reimbursement.

The second thing is that the market, even in ophthalmology, you're talking about 5 million use cases minimally per year. And that's just really cataract surgery. If you tack on glaucoma surgeries and other relevant procedures, and you can add another couple of million procedures. So for a reimbursed nonopioid, non-IV sedation medicament the opportunity in ophthalmology is very large. It's billions of dollars per year where our competition is IVs and opioids. I mean the data was a DUKE study. There's a MAYO study. The data is clear. Patients today are getting dosed with SENTINEL for sedation during cataract surgery in particular. And so we aim to change that. We've got to build our commercial strategy for the Gilt and that is underway. So that's the second component.

Other than that, outside of the U.S. market in ophthalmology and getting the studies completed and filing the NDA, if something happens where there's a partnership that is revealed or an opportunity like that, that's revealable certainly pursuing. But we have such a big revenue opportunity with the melt in ophthalmology that we need to really stay focused on that, and that's what we're going to do.

Our next question comes from Jeffrey Cohen with Ladenburg Thalmann & Company.

I guess 2 from our end. Firstly, Mark, Andrew, could you comment any on margins and/or tariffs and ramifications throughout 2026 or any net changes that you're seeing now from '25?

Andrew, you want to tackle tariffs? Margins?

Jeff, from -- yes, on the tariff side, we're not expecting much impact I think the analysis we did last year was kind of almost in a worst-case scenario, when we kind of relooked at things and we're doing that on a continual basis. The analysis we did last year is still holding strong, and actually, we're in better shape than we would have been last year in that worst-case scenario around the version day. So not to answer your question more directly, we're not expecting to see any impact on margins as it relates to tariffs this year.

Got it. And then secondly, any commentary on your mid-year expected launch on B as far as preparations and commercial organization and how that might look like midyear?

Andrew, you want touch on that at all. Anything you want to add there, we're -- I think we're ready to go where I think we start realizing revenue and the team's got a very unique strategy. Andrew, do you want to touch on that or Pat?

Yes, I can touch on a little bit and then hand it over to Pat. The -- Jeff, we're really leveraging the existing retina team with that launch. There's some incremental costs that will go into that. we'll have some variable costs as we get the hub up to help support the product. But we're just -- we're really excited to get that thing going. We've got a great partner in Samsung as well that's helping us help us as we prep. This is a very dynamic market. We're going to be getting in with BYOOVIZ right away in the middle of this year, which is in reference biosimilar. And then you may have recently seen that same thing announced they had entered into a settlement with the innovator drug for EYLEA, and so we'll be able to get into the market a little earlier than we expected with that product as well at the beginning of next year, which will be in January. But spend perspective, like I said, we'll leverage most of the existing sales force. There be some small incremental costs there and maybe some variable costs related to the hub activity for the products, which should be highly, highly accretive to earnings or new revenues.

Pat, do you want to add anything?

Thanks, Andrew. I think 1 thing to add is as Mark mentioned, we're really excited to get this going. Thinking about back to Mark's comments about the team that we have here. a very deep set of heritage in the retina space. So I think to me, we will capitalize on that very quickly. I think in addition, when you think about our current portfolio, we made significant strides in growing our retina business, and this is going to help us significantly with our presence in growing the value of that franchise. And we are actively right now preparing the market and targeting our business to take off here in the middle of this year. So we're super excited about BYOOVIZ forward.

Our next question comes from Yi Chen of H.C. Wainwright.

Could you comment on your marketing strategy for the biosimilar? What they will have a dedicated sales force and how you are going to present your biosimilar as a differentiated product from other casual competitors?

Yes. So thanks for the question. As I think Andrew referenced and as Pat discussed. And I think, as you know, it is a highly dynamic market. It is competitive. And we have a unique place in the market with our Lucentis reference biosimilar. And at this point, I really don't want to reveal specifically how we're going to attain the market share that we expect to drive towards. What I have said in the past is that based on our cost and getting into the deal, the level of success that we need to achieve to make this highly profitable is quite low. We're not planning to get 30% market share with BYOOVIZ. We're planning to get a handful of percentage points of market share in this market, which is the largest market in ophthalmology by revenue. And so our expectations are quite modest, and we believe that the strategy that we're going to employ with the team that we have, which, as Pat said, has a tremendous background in relationships, and this market is going to be successful in helping us get to our goals. But we don't have we're trying to get about a handful of percentage points of market share, which is what we've said historically.

I can add a little bit to the 1 big advantage we have compared to everyone else in this market. is we have other products that we're selling these doctors and so it allows us to provide a really comprehensive offering. You can talk about the patient experience with our anesthetic nonop has that anesthetic and so it's more than just the biosimilar products that we're going to be selling. It's this comprehensive package of products where we totally support the practice and focusing on the patient experience.

I'm showing no further questions. I'd like to turn the call back over to Mark Baum, CEO, for closing remarks.

Well, first, and this is not in my script, I have to say that this call is the longest call I think we've ever had. It was -- reminds me of our recent state of the union, it set a record. And so we're going to definitely work next time to try and make this call a little bit more efficient. So we apologize for the time that this call took. But I think it was worthwhile, and hopefully, anyone who is listening feels a lot more knowledgeable about where this company is and where we're going over the coming quarters and years. Across the portfolio, we're seeing tangible momentum, improved access, expanding adoption and growing commercial execution. We've got a great new commercial leadership team. Multiple products are scaling meaningfully. Key franchises are gaining depth, and we're seeing early signs of inflection where we've been patient and disciplined. And the result is that you own a business with increasing revenue concentration that is in durable high-value assets and that we have multiple pathways with other products for continued growth. I want to thank you for your continued confidence in here. We're building something durable and lasting and valuable, and we believe the most exciting part of our story is still ahead. This will conclude our call. Thank you.

Thank you for your participation. You may now disconnect. Everyone, have a great day.

Good day, and welcome to the Harrow Third Quarter 2025 Earnings Conference Call. [Operator Instructions] As a reminder, this call may be recorded.

I would like to turn the call over to Mike Biega, Vice President of Investor Relations and Communications. Please go ahead.

Thank you, operator. Good morning, and welcome to Harrow's third quarter 2025 earnings conference call. My name is Mike Biega, Vice President of Investor Relations and Communications, and I'm excited to be introducing today's call.

Similar to our last quarterly call, we will be presenting slides during the webcast today. If you have registered and joined through the live conference call link, I would highly recommend that you also join through the webcast. You can find the link in the Investors Section of our website at www.harrow.com or in our earnings press release that was issued yesterday.

The company's remarks may include forward-looking statements within the meaning of federal securities laws. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond Harrow's control, including risks and uncertainties described from time to time in its SEC filings, such as the risks and uncertainties related to the company's ability to make commercially available its FDA-approved products and compounded formulations and technology and FDA approval of certain drug candidates in a timely manner or at all.

For a list and description of those risks and uncertainties, please see the Risk Factors section of the company's most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission.

Harrow's results may differ materially from those projected. Harrow disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise. This conference call contains time-sensitive information and is accurate only as of today.

Additionally, Harrow will refer to non-GAAP financial metrics, specifically adjusted EBITDA and/or adjusted earnings as well as core results such as core gross margin, core net income and core diluted net income per share. A reconciliation of any non-GAAP measures with the most directly comparable GAAP measures is included in the company's earnings release and Letter to Stockholders, both of which are available on the website.

Now joining me on today's call are Mark L. Baum, Chief Executive Officer; Andrew Boll, President and Chief Financial Officer; and Patrick Sullivan, Head of Commercial.

With that, I would like to turn the call over to Mark. Mark?

Thanks, Mike, and good morning to everyone. Thanks for joining us today.

As always, please review our supplemental documents for the third quarter, including our earnings release, corporate presentation and Letter to Stockholders, all of which are now available on the Investor Relations section of our corporate website.

During this call and in future quarterly conference calls, I'm pleased to have Pat Sullivan, Harrow's Head of Commercial, join us. Next quarter, I intend to have our Chief Scientific Officer, Amir Shojaei, join us as well.

Today, Harrow is one of the leading providers of ophthalmic disease management solutions in North America. Our portfolio helps manage both front and back of the eye conditions. And I believe we are the only ophthalmic company in the world to offer branded, generic, over-the-counter, compounded and biosimilars, literally every legally available type of ophthalmic medication.

At the center of everything we do is our vision to become the next great U.S. ophthalmic company. Now 12 years into building this patient and physician-centric business, I believe we're still just getting started.

Our key products are in their early stages of launch with tremendous and durable growth ahead as adoption continues to accelerate. Over the next 2 years, we have 4 new product launches scheduled, each representing a significant opportunity to expand our reach, strengthen our leadership and pave the way for even greater growth in the future.

I am particularly proud of the fully scalable commercial infrastructure we've built, which will soon support multiple launches and continued expansion without requiring heavy additional investment. Combine that with a low-risk, capital-efficient pipeline development and M&A strategy and it's clear, Harrow's growth and market impact are in their infancy.

Now our momentum continued during the third quarter with rising revenue and clear evidence of the operating leverage in our business model. As I've mentioned before, some areas of our business will overperform while others may lag, sometimes due to seasonal factors.

And the third quarter was no exception. What matters most, though, is the overall trajectory of the business and that trajectory remains very strong.

Our key growth engines such as VEVYE, IHEEZO and to a certain extent, beginning very recently, TRIESENCE are rolling and momentum continues to build across the business, especially as we approach the launch of the Samsung biosimilar portfolio and conclude the acquisition of Melt Pharmaceuticals, which I'm very excited about.

Now VEVYE and IHEEZO continue to lead the way and are on track to finish the year very strong. In fact, 2025 is expected to be a record year for both products. They've shown consistent momentum and continue to drive the majority of our growth.

Driven by strong demand and best-in-class clinical performance, VEVYE delivered 22% quarter-over-quarter revenue growth. Perhaps a key highlight of my remarks, though, should be the news that we have recently signed agreements with several leading national payers for VEVYE.

Beginning in January 2026, only a couple of months away, VEVYE will be listed on multiple new formularies with a preferred product status, including the largest U.S. pharmacy benefit manager.

This means that certain products are becoming uncovered and that creates an opportunity for prescription transfers. And going forward, VEVYE will be covered on those formularies. This particular PBM covers tens of millions of lives and I view this as a major development for VEVYE and for Harrow.

With major improvements in coverage and the addition of Apollo Care and Alto joining our specialty pharmacy network this quarter, we expect a higher proportion of patients will receive VEVYE as a covered therapy.

These advancements strengthen VEVYE's market access foundation and fuel continued prescription growth, resulting in an improved ratio of covered to cash pay prescriptions. This includes estimates of current cash pay patients who are likely to convert to covered prescriptions and that gives us confidence in VEVYE's pricing stability and long-term growth.

IHEEZO also had an excellent quarter, delivering 20% quarter-over-quarter revenue growth. That's an impressive performance, given the typical seasonal slowdown for that product in the third quarter.

Meanwhile, TRIESENCE in our rare and specialty portfolio underperformed this year, as I talk more about in our stockholder letter and that also included the third quarter. The good news, though, is that we have the right leadership and strategies in place, I believe, to get both on track in short order.

TRIESENCE, in particular, is gaining traction in retina. And as of October of this year, we launched it in its largest market opportunity yet, ocular inflammation. Our rare and specialty portfolio also has new leadership and they are supporting our Harrow Access for All program, which is positioned to return this portfolio to growth, beginning in the fourth quarter and into 2026.

Please review the Letter to Stockholders for more specific thoughts, though, on TRIESENCE and our rare and specialty products portfolio.

We also made important strategic moves this quarter as we work to complete the acquisition of Melt Pharmaceuticals and its non-opioid procedural sedation candidate, MELT-300 and we also expanded our Access for All model across our entire ophthalmic portfolio.

We're also preparing for 4 product launches over the next 3 years, BYOOVIZ, OPUVIZ, BYQLOVI and MELT-300, which I'm particularly excited about. In short, our strategy is bearing fruit.

We're executing with discipline, scaling with purpose and building a company defined by innovation, access and sustainable growth, creating meaningful, long-term value for both patients and shareholders.

Before I hand it over to Andrew, I want to take a moment to address our ImprimisRx business in California, where, as many of you know, we have been engaged in a dispute with the California Board of Pharmacy for many years.

ImprimisRx remains licensed to operate in California, but its license is up for renewal on December 1, 2025. We are actively communicating with the California Board towards a global resolution, which would include a renewal of our license.

Because these discussions are ongoing and frankly, no outcome can be certain, I can't comment on other specific details, but this is top of mind for us and we believe a solution may be at hand. As more information becomes available, we will communicate with our stockholders.

With that, I would like to now turn it over to our President and Chief Financial Officer, Andrew Boll. Andrew?

Thanks, Mark. And thank you to everyone joining the call today.

Turning now to our financial performance. Total revenue for the third quarter was $71.6 million, representing a 45% increase over the same period in 2024 and a 12% sequential increase from the second quarter of this year.

For the first 9 months of 2025, total revenue reached $183.2 million. We remain firmly on track for another strong year of revenue growth, advancing toward our long-term financial targets with disciplined execution.

Based on what we're seeing across the business today and which I'll walk through in greater detail on the next slide, we are updating our full year revenue outlook to a range of $270 million to $280 million. While hitting our original target of over $280 million is still within reach, we want to take a slightly more conservative approach and update guidance to a range we believe we can deliver on.

Adjusted EBITDA for the third quarter was $22.7 million with GAAP-based net income of $1 million.

Operating expenses continue to be relatively stable quarter-to-quarter and we are seeing more operating leverage manifest itself within the new revenue gains. As we continue to scale, our ability to translate revenue growth into earnings remains a core strength of Harrow's model.

As we advance into the fourth quarter, we expect to see operating expenses moderately increase as further investments are made in our commercial infrastructure to accelerate sales and that trend should continue into 2026.

Let's turn to our product performance. VEVYE continues to outperform, generating approximately $22.6 million in revenue during the third quarter. This is a 22% increase from the second quarter of 2025.

This revenue increase was driven on continued increase in unit volumes year-over-year and quarter-over-quarter. VEVYE is set up for a record fourth quarter. October hit an all-time high in prescriptions and that momentum has carried right through the first week of November.

Q4 was VEVYE's strongest period last year. And with the trends we're seeing, I'm confident we're on track to finish near our $100 million annual revenue target for 2025, with additional, meaningful growth expected in 2026 as improved coverage kicks in and we further invest into VEVYE's commercial infrastructure to fuel the next phase of growth.

Turning to IHEEZO. Revenue for the third quarter came in at $21.9 million. This is up 20% from the second quarter. As we've seen in prior years, the third quarter tends to be seasonally softer due to the July and August slowdown as both patients and physicians take time off.

That said, demand rebounded sharply in September and remained strong through October. IHEEZO has significantly outperformed our expectations this year and is also on track for a very strong fourth quarter and a record year.

The fourth quarter has historically been IHEEZO's highest volume quarter, supported by end-of-year ordering patterns and stocking activity and we've already seen large orders placed early in the period. Based on those dynamics, we expect IHEEZO to deliver a strong close to 2025.

Our TRIESENCE and broader specialty branded portfolio generated $6.9 million in revenue. This is a 33% sequential increase.

As Mark discussed and highlighted in our Letter to Stockholders, with new leadership in place, a dedicated sales force, the launch of Harrow Access for All and TRIESENCE's launch into ocular inflammation, we now have the focus and strategies in place to reignite growth starting as early as the fourth quarter of this year.

ImprimisRx products continue to provide stable recurring revenue, generating approximately $20.1 million of revenue in the third quarter. As Mark mentioned earlier, if we are unable to resolve the dispute with the California Board of Pharmacy, we may see a minor impact on ImprimisRx's fourth quarter revenue.

In addition, ImprimisRx had an inventory shortage during the month of October, causing a onetime decrease of about $4 million to $6 million in its revenue for the fourth quarter.

In summary, we are fully focused on achieving our third consecutive year of 40% or higher annual revenue growth with all hands on deck across the organization.

VEVYE and IHEEZO are both positioned for a strong finish to the year and a record quarter. However, given the certain near-term factors, we're updating our full year outlook to a range of $270 million to $280 million. While our original target is still within reach, this new range is one I believe we can deliver on based on where we are today.

That said, the fundamentals of our business remain strong and I couldn't be more confident in the long-term growth trajectory.

Looking ahead, following what we expect to be a strong fourth quarter, we anticipate a typical seasonal decline from Q4 2025 to Q1 2026, likely consistent with the pattern we saw earlier this year. This doesn't mean that we won't achieve record results next year, which is what we expect to happen.

However, we want to establish that Q1 presents a seasonality that we need to consider. I'll provide more color on the magnitude of that dynamic when we report full year results, including the expected impact from the fourth quarter stocking activities.

Thanks, Andrew. My responsibility as Harrow's commercial leader is crystal clear, unlock the massive commercial potential in our portfolio and position Harrow for sustained, profitable growth.

As many of you know, I've been in this role for less than 6 months, but I am not new to commercial leadership, building successful teams to execute thoughtful strategies and ultimately delivering extraordinary results.

I would like to highlight the 5 commercial priorities that will drive my team's efforts. First, we're activating our advanced, key account management initiative. This is about deepening relationships with high-value accounts, fueling trial, accelerating adoption and building long-term loyalty across the brands.

Second, we're elevating our focus on driving depth and breadth, expanding our reach to more prescribers and new accounts while going deeper within existing users. This is key to unlocking the full potential of our portfolio.

Third, we have a scalable investment model across the commercial organization, one that allows us to grow efficiently, invest intelligently and maximize return on every dollar spent.

Fourth, we're expanding awareness of our Harrow Access solutions program to ensure a smooth and positive experience for both eyecare professionals and their patients. Removing barriers to access remains a cornerstone of our strategy.

And finally, we're sustaining operational discipline and stability, maintaining an efficient cost-base, while continuing to execute at a high level. These commercial acceleration priorities position us to drive stronger adoption, profitable growth and continue our journey as an emerging leader in the ophthalmic market.

VEVYE continued to strengthen and expand its position in the dry eye market during the third quarter, delivering strong and sustained growth. Our commercial strategy is working. We're seeing increasing physician confidence, excellent patient outcomes and faster, more affordable access to therapy.

By the end of September, we saw a 36% increase in prescribing physicians, a strong indicator of continued growth and expanding physician adoption.

Our VEVYE Access For All initiative remains a key enabler of growth for VEVYE, simplifying the patient experience and fueling demand.

Starting in January, VEVYE will appear on several new national formularies with preferred status, including the largest pharmacy benefit manager, the United States. VEVYE's improving coverage serves as another catalyst to expand utilization among eyecare physicians and among more patients with dry eye disease.

We anticipate that these increased coverage wins, many current cash pay patients will take advantage of VEVYE's improved coverage in their plans.

We also expanded our specialty pharmacy network. PhilRx handled all prescriptions in Q3, while Apollo Care went live in Q4 and [ AltoRx ] will follow later this quarter, steps to further improve patient access for patients. Combined with the broader payer coverage coming in 2026, these developments favorably position VEVYE for continued growth and pricing stability.

Let's look at VEVYE's outlook. Looking at the chart on the top left, the picture is clear. The dry eye disease market is large, active and growing. Branded segment is the key driver for growth in the overall market.

By the end of the third quarter, VEVYE captured 10.5% of the total dry eye market, up 2.7 share points from the prior quarter, effectively doubling its market share in just 2 quarters. It's a clear sign of strong, sustained growth and proof that our strategy is delivering results.

Our goal remains the same, to make VEVYE the number one prescribed cyclosporine therapy in the U.S. and we're making steady progress toward that. We're building momentum every quarter, increasing adoption, improving access and expanding coverage and we remain confident in our path to becoming the leading cyclosporine therapy in the dry eye space.

Looking ahead, we're focused on accelerating growth through both depth and breadth, deepening utilization with existing eyecare physicians, while expanding use among new physicians and their patients. Now that we are comfortable with our supply, we are also preparing for the next phase of expansion with plans to invest in VEVYE's commercial infrastructure and open 10 additional sales territories to fuel the next phase of growth.

We anticipate that more territories will open during the first half of 2026 and we are going to focus on markets served by the new plans that will cover VEVYE.

The momentum behind VEVYE is clear. With growing adoption, strong clinical outcomes, a patient-centric access model and improving coverage, we're just getting started. VEVYE has doubled its market share over the past 2 quarters and with new investments in our commercial infrastructure to support the next phase of expansion, the opportunity ahead is tremendous. I'm confident our team is fully aligned and focused on making VEVYE the new standard of care for dry eye disease.

Let's look at IHEEZO. IHEEZO had another excellent quarter. Unit demand was up 47% from last year and 3% sequentially. That's strong, sustained growth and continued proof that IHEEZO's value proposition is resonating in the market.

As expected, the third quarter followed normal seasonality, a brief slowdown in July and August, but demand rebounded quickly in September and continued through October. With a large order already placed in October, entering its strongest quarter of the year when we typically see increased stocking activity, IHEEZO is well positioned for a strong finish to 2025 and real momentum heading into 2026.

Our strategy is working exactly as planned. The retina pivot we executed last year, along with our new IHEEZO For All education initiative is driving awareness, engagement and adoption across retina practices.

Nearly half of the accounts ordering IHEEZO this year are brand new, a clear sign that we're expanding reach and deepening loyalty. With an 86% reorder rate, IHEEZO is not only winning new users, but also keeping them, a strong foundation for sustained growth ahead.

Looking ahead, we're still just scratching the surface of IHEEZO's potential. We're in the very early stages of this growth story and the opportunity ahead is tremendous.

Our retina team is focused on both driving both breadth and depth, reaching new accounts and deepening relationships with existing customers and expanding awareness among retina specialists.

As adoption continues to grow, we're confident that IHEEZO will become an even stronger growth engine for Harrow, especially once we introduce our biosimilars starting in mid-2026.

Shifting to TRIESENCE. TRIESENCE is showing real progress in the retina market. The trends we're seeing now indicate an acceleration in adoption and growing traction across the retinal community.

Since relaunching TRIESENCE last October in 2024, there has been a 4x growth factor with significant headroom remaining. TRIESENCE unit demand grew 67% sequentially.

Importantly, more than half of the accounts ordering TRIESENCE in the third quarter, about 53% were new customers. That tells us our reach is expanding and physicians are responding to TRIESENCE strong clinical performance and favorable reimbursement profile.

With its proven safety, excellent efficacy and broad payer coverage, TRIESENCE is well positioned to continue gaining share in the retina market.

The big news is our official launch of TRIESENCE into the ocular inflammation market, the largest and most promising opportunity for the brand to date. We're still early in the launch, but the response from the field has been encouraging.

Physicians are giving strong, positive feedback and early utilization trends are moving in the right direction. The early traction reinforced exactly what we believe from the start that TRIESENCE delivers real clinical value and fits seamlessly into physician workflows. We see this launch as a true catalyst, opening a major new growth channel for TRIESENCE.

With proven safety, strong efficacy and broad payer coverage, TRIESENCE is gaining traction in the retina market and has just entered its largest opportunity yet, ocular inflammation with positive early feedback. As awareness builds and adoption expands, I'm confident TRIESENCE will become a key growth driver and increasingly important contributor to Harrow's leadership in ophthalmic care.

Turning to Rare & Specialty products. This is an area of untapped potential for Harrow. Earlier this quarter, we're excited to welcome Tom Pertallo as the Vice President of this segment.

Tom brings deep commercial experience and a proven track record of driving growth and his leadership comes at exactly the right time as we work to unlock the full value of this portfolio. Right now these products represent less than 1% of the total market volume, which means the upside is significant.

With Tom leading the charge and a dedicated sales force being built to focus exclusively on this business, we're tightening execution, reenergizing our commercial approach and positioning these brands to return to growth.

We're also launching the Harrow Access for All program this quarter, which will improve affordability and expand patient access, key levers to drive sustainable growth across the portfolio. This portfolio once generated nearly $10 million quarterly revenue and we see a clear path to reignite that growth and ultimately exceed those levels.

With strong leadership now in place, renewed focus and clear strategies in place, I'm confident this business is positioned to return for growth and deliver stronger, more consistent performance moving forward.

To close, I couldn't be more excited about where Harrow is headed. We're still very early in the growth stage across all of our key growth drivers with significant catalysts and ample room for further growth.

We are well positioned for our next stage of growth. Our commercial momentum is strong. The plan is clear and the opportunities in front of us are huge.

In dry eye, VEVYE continues to lead the charge, expanding its share, broadening access, improving coverage and deepening adoption among prescribers. In retina, we're strengthening relationships, expanding awareness and gearing up for 2 major launches, BYOOVIZ in mid-2026 and OPUVIZ in mid-2027.

In the Surgical segment, we're building a differentiated portfolio that supports the perioperative space, delivering efficiency and value for practices. In Rare & Specialty, new leadership, a focused plan of action and the launch of Harrow Access for All, are unlocking the potential of a diverse portfolio that represents less than 1% of its addressable market today.

The opportunity across these 4 segments is tremendous. With best-in-class products, a scalable commercial platform and a disciplined strategy for execution, we're building a company with durable, long-term growth potential.

Harrow's path forward is clear, stronger execution, expanding leadership and sustained momentum across every part of the business.

With that, we can turn it over to the operator for Q&A.

[Operator Instructions] Our first question comes from Jeffrey Cohen with Ladenburg.

Congrats on the quarter. A couple from our end. Firstly, could you talk about VEVYE prescription data and why we don't see it this quarter?

Jeff, this is Mark. What we decided to do is to make sure that we have the most accurate information available. As you know, we withdrew from some of the reporting services, some of the data reporting services a few quarters ago.

And it's really important that we have confidence, absolute confidence that what we're putting out is accurate as possible. And from our perspective, I think, the key metric was revenue generated from these products and not necessarily IQVIA data or data from a data feed that may or may not be completely accurate. So because of that, we decided to change the way that we're reporting.

Andrew, do you want to add to that at all?

Yes. The only other part of that to add to what Mark was saying is really one of the reasons we're pulling out of these third-party aggregators were for competitive reasons. And so if we're doing that, it didn't really make sense to us to present the data and make it available to all of our competitors in our earnings release. That's driven a lot of the decision-making with presentation of the [ TRx ] data.

But to Mark's point, we're going to do our best to be transparent about the progress of VEVYE without giving up competitive positioning.

Okay. That's perfect. And then secondly, maybe for you, Andrew, could you talk about the leverage that you're achieving? You had some pretty nice leverage on the SG&A in the third quarter. But as you continue to expand your commercial teams, how should we think about leverage overall into 2026, mainly as a percent of revenues?

Yes. And this has been a topic for us that we brought up for a long time now where we expected to see operating leverage, especially this year in the model on the new revenue growth we expected.

We spent a lot of money on the operational and commercial infrastructure to support the branded group. That is mostly in place and we're seeing that leverage show up in the numbers.

Obviously, Q3, we had great adjusted EBITDA just under $23 million. The business is producing a lot of cash, I think about $16 million of cash in the third quarter from operations. And as we look out, Pat talked a little bit about adding to that commercial infrastructure to drive revenue.

The additional OpEx that we're looking at is revenue-generating OpEx, so we should start seeing immediate return on that expense.

So again, even though we're going to be making investments in the commercial infrastructure, it's not like it's going to be a 50% increase in OpEx, it's going to be a moderate increase. And importantly and this is probably the most important thing, that investment in the expense should see almost an immediate impact and return on revenue.

Our next question comes from Chase Knickerbocker with Craig-Hallum.

Maybe just first to start, a couple on VEVYE. Mark, you had mentioned in the stockholder letter that ASP was down modestly sequentially in Q3. Could you just define the magnitude of that modest decline for us just so we can kind of understand that?

And then just as we think about, you kind of spoke to stabilization in the near term. Can you just walk us through some of your modeling assumptions on VEVYE that kind of lead to that ASP stabilization in the near term? Is it improving mix that you're seeing so far in October? And then I've got a follow-up.

In terms of defining what modestly means, I can't give you a definition with precision. I mean, it's -- I think it's less than 10%. But I think the more important issue is how is ASP or net revenue per unit, how is that going to stabilize in the near term and then as I said on prior calls, begin to float up?

What is the justification for that? And to be very clear, we are really counting on coverage coming through. We're counting on the ratio of covered prescriptions versus cash pay prescriptions to flip or begin to change so that there's more of a bias towards covered prescriptions versus cash pay prescriptions.

If that happens, that's when you see the stabilization happen, that's when you see the ASP begin to float up. And the beautiful thing, I think, the exciting thing for us and I think you've actually noted this in your notes that I've seen is that that increase will affect the entire corpus, every single unit of VEVYE.

And so the question is how and when is that going to happen? And I tried to address that in the Letter to Stockholders. We discussed that in our prepared remarks.

And we now have landed this coverage win with the largest pharmacy benefit manager in the U.S. and specifically their commercial lives group, you're talking about tens of millions of new potential lives covered. And when you think about that ratio of covered prescriptions versus cash pay prescriptions, beginning January 1, we anticipate that ratio is going to begin to flip.

Actually, to be candid with you, I've had doctors send me letters that I know that have already gone out from this benefit manager to the physicians, letting them know about the plan changes that will take effect, drugs that will not be covered and the specific patients' names who will no longer be covered for that product and letting them know what the new formulary looks like.

So this is really exciting for VEVYE. We expect to start seeing some of those changes, those prescription flips from other dry eye products to VEVYE in the fourth quarter. We expect that will start to happen, but it will really kick in, in the first quarter.

And as I said, once that takes place, that ratio of covered versus cash pay will begin to change, you'll see that stabilization happen and I think, as I said in the last call, we'll start to see, I think, a bias towards ASP improving and potentially improving maybe even more than modestly.

Yes, that's what I was hoping to follow-up on is just any more specifics you'd be willing to share as far as the largest PBM, that win? Was it the commercial plans? Was it commercial and Medicare?

Just any sort of details there. And then as we think about that ASP improvement, to your point, any way you can help us kind of define how you see your current volume and kind of the amount of your current volume that could benefit from that win and how that affects ASP? And any thoughts you'd be willing to give there as we enter next year?

Yes. I would say that these are commercial lives, number one. So they're, I would say, the most attractive of those lives that you can get. So it's a major coverage one.

I was talking to our team earlier and I said, I hope that our investors, the main takeaway from the stockholder letter, I think, it's the most important part of the stockholder letter is this coverage win, because it dramatically changes things. I mean, if you get a $20 or $30 or $40 improvement and I'm not suggesting that we'll see a $40 improvement on ASP, but if it's a $20 improvement as an example, it affects every single one of those units.

And as units are growing and they will grow regardless, we are going to see significant improvement in total units for VEVYE. But the question is how much money are we going to make from all of those units. And I think that this improvement in coverage is going to be a major factor at the beginning of this coming year.

And you also know that we are very conservative in terms of how we invest commercially. We don't do extravaganza launches because we dip our toes into the water, we kind of get in, we see what works. It's just our style and it's the way that we've been able to invest in new product launches.

And for us to now make investments in VEVYE and specifically open up 10 new territories in the very near term and then I think by the middle part of next year, we're going to have upwards of about 100 total territories for VEVYE.

The reason why we're making those investments is because candidly, it would be malpractice for us not to make those investments now that we have such strong coverage in these specific markets.

So we're very bullish on VEVYE next year. I think you can expect to see some improvements in ASP as this ratio begins to flip and bias more covered versus cash pay prescriptions. And it's a really good time for VEVYE and the drug, by the way, is phenomenal.

If you've ever put the drug in your eye, it's phenomenal. I think it's the best product in the class. So it does a great job and patients love it and the refill rates are absolutely extraordinary, I believe, best-in-class.

Our next question comes from Steve Seedhouse with Cantor.

Hoping just to start you could give us a sense of what proportion of the VEVYE cash pay patients currently you'd actually expect to transition to insurance coverage in 2026 and just ballpark the expected impact that that particular variable would have on net price per unit.

Yes, I can't -- I don't know that we can give you the answer with precision. We actually have built internal models to try and estimate what that would look like.

This is the largest commercial PBM. And if you just model out how many dry eye patients they have and we do know how many dry eye prescriptions come from those plans, we can see a couple of things happening.

One, as I said, there are patients that have been denied coverage from those plans who are paying cash, who we will be able to reach out to and hopefully transition them from cash pay to covered because this is not just a nonpreferred brand status. This is a preferred status. So this is the lowest or in some cases, no co-pay type coverage. So it's really favorable coverage for VEVYE.

And then, of course, we, as I said, seeing the letters that have already gone out to physicians, letting them know that legacy products that patients were being prescribed are no longer covered. I know what those specific products are.

And I mean, I was looking at the number of patients, of course, not looking at the specific patients' names or any of that. But just one physician in one small community on one street, the number of patients and you start adding up these letters going out to thousands and thousands of physicians and it could be -- it could absolutely hit what we are thinking about internally in our modeling.

Andrew, do you want to add to that at all?

Yes. I think the one thing that I'm really excited about this coverage win is it kind of shows what -- and then I think we're going to really see it next year as we demonstrate the power of VAFA, which is really a long -- it's -- the VAFA program is, I almost call it a temporary program. It's not meant to be the program forever.

The goal of the program is to gain coverage wins and to increase patient access through insurance reimbursement. And through that, we think ASP will improve. What's great about the program, though, is it also sets us up where we kind of have a base to work off of when we're negotiating with PBMs and payers. There's no reason for us to take less money from a payer.

So when we're bidding, we're not going to bid ourselves into a hole. The VAFA program is working really well. I mean, it's exceeding our expectations on the cash pay side. And what that's doing is setting us up for a lot of long-term growth for the product, especially as the insurance wins come in and we think they will.

And we think that the program itself, just with the volume and demand we're seeing, brings us more negotiating power when we go to the payers and go through these bid cycles. And I think this -- like I said, this first coverage win is a good demonstration of that and we should see more of that in '26 and '27.

I just want to ask, just focusing on, I guess, fourth quarter specifically and on that point, you were just noting like you're in this moment, right, where the volume growth is tremendous and you have this sort of couple of month window between now and 2026, where it would be critical to keep people on drug until their insurance coverage kicks in.

So are you doing anything like providing free prescriptions beyond the first month to VAFA patients? Or just anything new to bridge that gap given the new coverage decisions that would impact fourth quarter revenue?

And then on the flip side, just with the addition of the new specialty pharmacies, is there any expected like inventory or stocking or sort of onetime impact to fourth quarter that we should be considering for our models?

Andrew, why don't you take the last question and I'll touch on the first question and ask Pat for some guidance as well.

Yes. On the -- on any inventory stocking, Steve, I don't think we'll see anything really that impactful with VEVYE in particular for the fourth quarter. These guys are ordering pretty almost just-in-time type ordering, not quite that regularly, but it's -- I would say they're taking less inventory than wholesalers typically would. So no real end of year impact related to that.

And specifically on keeping patients on therapy, I don't know that we want to go into any specific tactics, but I know that the dry eye team, Maria and her entire team are hustling. Pat, do you want to add to that at all?

Yes. Thanks, Mark. I think this is a super exciting opportunity and this is part of the plan. So I think to me, we have a very, very clear activation plan to really take advantage of evolving from VAFA to support these patients to really capitalizing on our managed care wins.

And I think to me, it's very much focused on the communications that are happening from the plans at this point in time to their patients, making sure that doctors know about our VAFA program and these wins that are going to be taking place to ultimately support the patient end of the year.

So we have a very robust high-touch program that is taking place and activating as we speak now that will continue to wrap up the year to support these patients and really accelerate growth at the end of the year.

I think in addition, our program right now, our fill program in VAFA is a very high-touch program. So we have a very, very clear view into who the patients are that are coming on our product and that are eligible for conversion to this commercial win. So super exciting time. But to answer your question, we have a very clear plan to really drive conversion and help these patients.

And I'll just add that I was excited. As soon as we got the coverage win, we got that information, I'll tell you, it gave me a lot of confidence in Pat and Maria and the team.

I mean they had -- I think they even had a name for the plan internally that they were going to begin to execute. And it was just a text message. It was just like, okay, let's fire it up. And it just gave me a lot of confidence that we have the right people, we have the right strategy to take advantage of this great opportunity and continue the growth in VEVYE. So kudos to the work that Pat and Maria are doing.

Our next question comes from Mayank Mamtani with B. Riley Securities.

Appreciate the detail on business momentum. So maybe just a high-level question on sort of this 3Q to 4Q dynamics. Some you observed last year versus others you were talking to are unique to -- you have this year.

Was just curious if you could comment a little bit on the notably high sort of $80 million revenue threshold in 4Q. It's sort of sequentially double versus what you had in 3Q. And it seems a lot to be still driven by VEVYE, I think, 60% over sequentially.

Any color, Mark, you can give on volume versus price kind of dynamic here that you're assuming across the different lines -- different product lines? And then I have a follow-up.

On Q4, what I would say is I think last year, Andrew, Q4 was probably upwards of 1/3, maybe a smidge higher than 1/3 of our overall revenue for the annual period. That will -- I wouldn't expect that to change this year.

I think that we can do around that range this year. I think the exciting thing about Q4 for what it's worth is the emergence of TRIESENCE finally. I think we -- I was quite candid in the letter. We could have done a lot better. We should have done a lot better with TRIESENCE in every period this year, the first 3 periods and the same is true with our Rare & Specialty portfolio.

But the key is, is that we've taken action. TRIESENCE, I think we're seeing really exciting things, not just in words, but in deeds. As I was telling the team, we're not at a point where Mark can get on a conference call and say, "Hey, I'm really excited about TRIESENCE. I think this is going to be fantastic."

It's time for orders. It's time for revenue. It's time for reorders. It's time for new accounts starting and adopting. And because I'm seeing that, I'm actually -- I've been involved in the sales process myself. I've been communicating with high-volume surgeons and talking to them about TRIESENCE specifically and I'm actually seeing surgeries start with it. And that's exciting.

I've been through that cycle. I've seen that cycle. And so that gives me a lot of confidence in where we're going with that product, not only beginning to feather in, in the fourth quarter, but really for next year. It's going to get to where we thought it would be and that's super important. In terms of other dynamics between Q3 and Q4, Andrew, do you want to comment on any of that?

Yes, Mayank, I think we've kind of talked about VEVYE on the ASP side and expecting at least stabilization there. Typically, at the end of the year, your patients are out of that co-pay deductible and amounts like that.

So our co-pay buydowns are a little bit lower on a per unit basis. So hopefully, that helps to see a little bit of price improvement. But in general, the expectation is we're going to see volume improve across the portfolio that will drive most of the revenue growth for the quarter.

Great. And then one -- actually a couple of specific product level questions. So Project Beagle enabled patients who crossed over to branded VEVYE. You may have some information there on the conversion rate from cash pay maybe to commercial insurance covered scripts. I don't know if that was something you can share or has given you some learnings moving forward?

And then on TRIESENCE, are you able to comment on what the new price point is? Looks like you're really focused on access to enable significant volume growth as you enter the ocular inflammation market. And obviously, very curious to hear your goal here to -- how close you're trying to get to when the product was not on the shortage list a few years ago?

In terms of Project Beagle and specifically the transition from Klarity-C to VEVYE, we really don't have much more to add to that. I think we had more than 25,000 patients that were using cash pay Klarity-C.

We stopped making Klarity-C in the summertime. And I think largely, those conversions have taken place. There's probably some units out in the field in various offices around the country.

But I expect for that to be kind of mopped up by the end of the year for sure. And those patients who will have transitioned to VEVYE will have made that transition.

In terms of TRIESENCE pricing, the pricing was at $9.44. You're moving into the ocular inflammation market. The products in that category are probably 20%, 25% lower in price. And I believe and I think our team believes that price was -- would have affected adoption and in particular, as we focused on that ocular inflammation market.

It was a good move, by the way. New orders are coming. As I said, it's not Mark talking about what might happen, what could happen. It's Mark talking about orders coming in, revenue reorders.

And as I said in the stockholder letter, we have now confirmed reimbursement. So you're talking about a product that is -- has tremendous coverage, an extraordinarily low prior authorization rate, a multi-decade track record of performance. It's a product that is, I would say, beloved by ocular surgeons.

And there are a number of other reasons why -- clinical reasons as well as economic reasons why TRIESENCE is so exciting to these physicians that really didn't know that this level of reimbursement was available for this product.

So we are seeing really positive things. I have been through this before. Our first product was a product called Tri-Moxi. It was a compounded combination of triamcinolone acetonide and moxifloxacin hydrochloride and I remember the adoption cycle there.

What happens in the surgical environment, in particular, is you get a few cases and I tried to describe it in the letter of stockholders and then they see that it performs terrific clinically. Now we've gone through the reimbursement cycle.

There's really no reason why these physicians can't use this pervasively throughout their practice. And so there is this cycle to adoption and we're going through those cycles right now.

What's really neat is once those physicians adopt this and it starts working so well for their patients and they see their patients coming in with clean white eyes on their post-op day 1, they don't want to change. And then when they talk to their administrators at their surgery centers and they hear that they were reimbursed and they didn't have to deal with prior authorizations, they just don't want to change.

And then it grows and grows and grows. At our peak with a non-FDA-approved compounded product, we were doing in excess of probably 300,000 units of Tri-Moxi and Tri-Moxi-Vanc years ago and some of these other sterile injectables.

And so when I think about what TRIESENCE had done many years ago versus what we were doing with a non-FDA-approved product, which was significantly more than TRIESENCE in terms of annual unit volumes, I say that the units that we were doing with a non-FDA-approved product were miniscule relative to what the overall market opportunity is.

And I just wonder why more -- why any surgeon would not use TRIESENCE. And so we think that this is going to become, hopefully, the new standard of care for these patients.

And if it was my mother, if it was someone that I love that was having a procedure and they could have the physician inject the medication to ensure that they had the medication on board and that they would not have to as a 75, 78, 80-year-old patient with comorbidities, have to administer eye drops post-surgery, I think I would want my mother's physician to choose TRIESENCE.

So we think more and more physicians will. It's an exciting time for that product and we're just scratching the surface. I don't even know that you could even call it a scratch at this point.

Our next question comes from Tom Shrader with BTIG.

Congratulations on the quarter. The TRIESENCE, that had a pretty good user base before and we agree people loved the drug. Is it easy to move back into those people? Or have they moved on?

Could you just give us a sense of is that low-hanging fruit? Are those people waiting for the drug? And then you commented on fueling commercial operations for VEVYE. Does that mean adding conventional salespeople? And if so what other products do you think they could most easily help? Is TRIESENCE too far away for someone to market both VEVYE and TRIESENCE?

Yes. I don't want to keep talking, but if you don't mind, I'm going to take both, if that's all right. In terms of how easy it is to reengage and whether these physicians have moved on, when TRIESENCE was not available, without question they moved on.

They started using [indiscernible] which has preservatives. It's got benzyl alcohol in it. If you're the patient, if the patient is someone you love, you don't want the doctor putting a chemical in their eye that could potentially blind them.

And so that is why Alcon many years ago sought FDA approval for TRIESENCE because there was a clear unmet need in the marketplace for a preservative-free triamcinolone acetonide and that is TRIESENCE. That's what makes the product very special.

And if you knew that an iPhone 17 was not available, maybe you go back to the BlackBerry. But boy, as soon as you found out that the iPhone 17 was available, you're going to switch back.

It does take time to reengage with these physicians. Many of them, even to this day, don't know that TRIESENCE is available, that it's in stock. They don't know about the low prior authorization rate, the reimbursement and coverage.

But that's our job. That's Chad's job. That's the job of this team that is going out, [ Aly ] and her folks and Adam and really making it happen for this product. And it takes time.

I mean, you're talking about thousands and thousands of call points, but they're doing a great job. They're making progress. I think Pat talked about that.

And for Harrow and our stockholders, the juice will be worth a squeeze. I mean, this is a tremendous product. I've always said that I saw TRIESENCE as a 9-figure revenue product. I think we're going to get there in due course. You wouldn't think that from the first quarter to the second quarter and the third quarter.

But I think if we speak this time next year, you will see that I was not delusional. And then finally, in terms of commercial ops for VEVYE, we're making those investments because we have coverage.

When you have coverage, when you have the ability to have a prescription written and to get it filled in sort of a friction-free way and what we do know, by the way, and we've talked about this in prior stockholder letters is that when we get a commercially covered VEVYE patient through our process, we retain them. Our refill rate is amazing for a commercially covered patient.

So once we get that patient now that we can get them covered, we can retain them because the product is so spectacular. It provides us with a sort of a compounding effect as we get more new patients and retain them, you'll see that continued growth.

In terms of other products that we're going to put in their bag, if you go through the corporate deck, one of the things I'm really excited about is we actually did add 2 products to the bag of our dry eye team. We have an amazing dry eye team.

It will be growing. As I said, by the middle of next year, we'll have 100 territories. So Maria is going to have a much larger group of folks to manage. And they will also be helping patients and giving them access to FLAREX and they'll be getting -- they'll have FRESHKOTE in their bag as well.

And so the combination of a chronic care dry eye medication with other related products that cover ocular inflammation and FRESHKOTE in particular, which I think if you Google FRESHKOTE, you start looking at some of the marketing materials and its ability through polyvinyl alcohol base to actually help patients retain their tears and prevent evaporation, I think that's a really terrific product that the team is excited about.

And by the way, it's over the counter. I think you can get it for under $30 a unit. It's over the counter. So you don't need a prescription for it. So we're going to do some exciting things with FRESHKOTE. Maria has got FLAREX now. And of course, the cornerstone product in her portfolio was VEVYE.

Our next question comes from Lachlan Hanbury-Brown with William Blair.

I guess I'd be curious on the new coverage for VEVYE. Can you just talk about how the economics there shake up or stack up compared to the current net pricing you're seeing? Because I know you've been sort of vocal, Mark, in the past about the economics that PBMs try to extract.

So would be interested to know just sort of where that shakes out. And also once those new plans come online in '26, what kind of coverage level are you looking at? Like what proportion of commercial lives nationally are covered for VEVYE?

Yes. What I can tell you, and Andrew mentioned this, is that when you have a VAFA program and you establish a base, it takes you out of what we would call desperation mode to do bad deals with PBMs. Andrew, do you want to kind of add to that? You talked about it a little while earlier.

Yes, without giving away the kind of bid, like Mark is saying, like I was saying that we kind of start with a base and we say, okay, if we're going to get a coverage win, what we want -- what does the economics need to be?

And it obviously has to be an improvement on the cash number that we have. And so what that means and what I think -- and without getting -- being specific about what that impact is going to be, the expectation is it's going to be an improvement for those patients over what they -- over the cash price that we would net on a per unit basis.

And we've talked a lot about just the ASP impact of the coverage win and that will help stabilize and certainly increase that number in 2026. But there's another aspect to this, which is VEVYE was not preferred in this plan and Mark kind of talked about this.

The fact that now it is preferred and another product got pulled out of that preferred status, the payer is letting the physicians know, hey, your patient was on this product and it's not going to be preferred next year, but VEVYE is.

So not only are we going to get the increase in ASP, but just getting that preferred status, the PBM is helping us drive volume. And so you're going to -- it kind of one begets the other, but it's going to be an increase in ASP. It should also be an increase in volume as well for the product.

Great. And maybe a quick one on the VEVYE expansion, the new territory. So just to make sure I heard correctly, is that you're adding 10 new reps this quarter and then we'll keep adding more until you get to about 100 next year, which if I have my numbers right, is sort of roughly double where you're at now?

Yes. So we're going to increase by 10. We'll get to a little bit more than 60 here in the very near term. And then by the second quarter, we'll hopefully have -- we'll reach the century mark, we'll have about 100 territories.

Our next question comes from Thomas Flaten with Lake Street Capital Markets.

Mark, just a follow-up. You mentioned the refill rates are great. Could you give us a sense of duration of therapy that some of these long-duration patients are on products for?

I think last time that we looked at the data for a commercially covered patient, if you look at their initial prescription plus the refills and you add -- you just think about the number of drops per bottle and the number of dosages per day. I mean, I think we were almost -- we were right at these commercially covered patients getting therapy for the entirety of the year.

I mean, I think it was only a few weeks away from, on average, refilling for the entirety of the year. I mean, we would have never ever thought that we would get that sort of affinity of refill rate for that patient. I mean, that was not anywhere even in the highest, the boldest of bold cases in our models. So that's what we've seen.

And Andrew, do you want to add to that at all?

No, nothing to add.

And then maybe if I could, bigger picture. You guys have been pretty busy on the BD front and have kind of created a really impressive to-do list for yourselves over the next couple of years.

What should we anticipate in '26, '27? Is this more of an absorb, digest and act? Or is it more deals, more deals? Where do you land on that?

Well, I think at our office today and over the next week or so, we are over the moon excited about Melt. And I don't think we've talked about Melt really at all, but we're hoping to get this closed here in the very near term.

And I don't think people really understand the value of Melt and what the potential is there. It's really transformative for us. And so yes, we can -- we look at deals constantly. We're always evaluating things.

But if you look at our portfolio and you think about some of the strategic goals that we've discussed and I've laid out even in the letter, in particular, around cataract surgery, the vision for ophthalmic surgery that we have, which is to have opioid IV and drop-free cataract surgery, that's exciting for patients. That's transformative.

The idea that you can probably go into an office, have office space, maybe even bilateral same-day cataract surgery and on the pharma side, have no IVs, no opioids and not need eye drops post-surgery, that's extraordinary. And that's what Melt and some of the other products that we have will enable.

That's transformative for the nearly 5 million surgeries that occur annually in the U.S. So we are looking at other deals. We're very interested in other deals. But right now we're super pumped about Melt.

We want to get that closed. We want to get the balance of the data collected and put into a dossier so that we can submit an NDA and get that product approved and help realize this vision that we have to really transform ophthalmic surgery.

And then eventually, hopefully see the MELT-300 drug candidate used outside of ophthalmology, which is really a much bigger market opportunity in dental and GI and claustrophobia for MRIs and the tens of millions of annual uses in the U.S. where we think the MELT-300 will be impactful.

And then, of course, what's also interesting is this will be the first global play that we have. Historically, we've been a U.S.-focused business. And as you, I think, know, MELT-300 is not only patented, multiple patents issued domestically, but in all of the -- many of the major markets around the world.

So it's a global opportunity as well that we hope to discuss with partners in other markets around the world. So lots to look at, but I'll tell you, when we look at what we have with Melt and the products that we've acquired over the years recently, we have just something very, very special that we need to execute on. And I'm really pleased to have Pat as my partner, our partner to help us do that.

Our next question comes from Yi Chen with H.C. Wainwright.

Mark, you mentioned that with the coverage win, some prescription flipped to VEVYE. Could you give some additional color on market dynamics, whether those prescriptions flip to VEVYE, they originally came from prescription for other cyclosporine formulations or they could be -- they came from non-cyclosporine prescriptions as well?

Yes. So the -- in terms of who is who -- which product was the -- incurred the loss to our potential win, it was really -- and I don't want to go into the specific products, but they were not cyclosporine-based products, but they were anti-inflammatories.

And you might be able to figure out which ones they were. But in any case, for us, we are really focused on being the #1 cyclosporine in the market. And I think this really adds to that momentum.

I think to be the #1 cyclosporine in the market, you're talking about, I think, with generics, probably 22%, 23% market share. We're a little over 10%. We do expect to see NTP improvement as we get more and more coverage and that ratio flips.

But this is going to really help us I think drive not only new prescriptions from patients naturally, but I think from these flips. As I said, I've seen the letters that have gone out to the eyecare professionals. It lists the product that is no longer covered and it lists the patients.

And I know from the few physicians that I've spoken to that their intention is to move them to VEVYE. However, I have to say, if you go around the country, there are many physicians in many markets all over the country that have no idea what VEVYE is.

And it's our job to make sure that they not only know about the clinical value that VEVYE brings, but also now the new coverage, which will, I think, create a more friction-free process for prescribing.

I'm showing no further questions. I'd like to turn the call back over to Mark Baum, CEO, for closing remarks.

Thank you, operator, and thanks, everyone, for their questions. And we really appreciate you joining us today. As we look into the future, I remain confident in where we're heading.

We've built a solid foundation. We've brought together an outstanding leadership team and defined a clear strategy that touches every part of our business. And we have a portfolio of best-in-class products and expanding access for patients and physicians and driving a culture that thrives on focus and execution. It positions Harrow for sustained growth and long-term value creation.

The opportunities that we have ahead of us with TRIESENCE and VEVYE and IHEEZO are tremendous and we are ready to capture them. If you have any further questions or you need additional information, please don't hesitate to reach out to Mike Biega. His e-mail address is m as in Mary, b as in bravo, [email protected]. This will conclude our call.

Thank you for your participation. You may now disconnect. Good day.

All right. We can get started. Good morning, everyone. Welcome to Harrow's Inaugural Investor and Analyst Day. My name is Mike Biega. I am the Vice President of Investor Relations and Communications, and we're thrilled to be here with all of you today. The company's remarks may include forward-looking statements within the meaning of federal securities law.

Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond Harrow's control, including risks and uncertainties described from time to time in its SEC filings, such as the risks and uncertainties related to the company's ability to make commercially available, its FDA-approved products, in compounded formulations and technologies, and FDA approval of certain drug candidates in a timely manner or at all.

For a list and description of those risks and uncertainties, please see the Risk Factors section of the company's most recent annual report on Form 10-K and subsequent quarterly earnings reports on Form 10-Q, filed with the Securities and Exchange Commission. We have a very full agenda plan for today.

We'll start with about 2.5 to 3 hours of prepared remarks, followed by roughly 30 minutes of questions. I do kindly ask that you hold all of your questions until after the presentations and then when we reach this Q&A session, raise your hand, I'll come around with a microphone and hand it to you. And once you have the mic, please ask your question.

As you have noticed, we don't have any formal breaks built into the agenda, but we do have lunch out in back as well as specialty coffee carts. So please help yourself whenever you wish. Today, we have several members of the Harrow leadership team here today. Joining me today are Mark L. Baum, the Chief Executive Officer, Chairman and Chairman of the Board and Founder; Andrew Boll, President, Chief Financial Officer and Founder; Amir Shojaei, Chief Scientific Officer; Prashanth Annavajjhala, Chief of Staff to Mark Baum; John Saherik, CEO of ImprimisRx; Pat Sullivan, Head of Commercial; Chad Brians, Vice President of our Surgical portfolio; Aly Harrison, Vice President of our Retina Portfolio; and Maria Lloyd, Vice President of Dry Eye.

On behalf of the entire Harrow family, I would like to sincerely thank all of the thought leaders that took time out of their busy schedules to join us today. We truly appreciate it. Each of these speakers will be formally introduced at the time of the presentation. Joining today is Larry Dillaha. No, sorry Maggie Jefferies, Paul Karpecki, Raj Patel and Sinu Hari Prasad. With that, I would now like to turn it over to our CEO, Mark.

Thank you. On behalf of the entire 400-plus Strong Harrow family, please know how grateful we are for your audience today, truly. And I want to especially thank Mike Biega for putting this event on. It's an incredible day for our company. So thank you. Great job, Mike. In 1945 in Fort Worth, Texas, Robert Alexander and William Connor, founded a small company called Alcon and over time, it has grown into the world's leading ophthalmic business. And just 3 years later, in 1948, Gavin S Herbert founded Allergan, which became the most -- one of the most important ophthalmic businesses in the world.

These 2 stories of Alcon and Allergan, remind us of the power of entrepreneurial vision. And the truth is that it's been more than 77 years since we've seen a great founder-led U.S. ophthalmic business emerge. At Harrow, our vision is simple. To become the next great U.S. ophthalmic company. And with only $1 million of invested capital and $1 trillion of determination, we've built Harrow which now owns the largest and most diversified portfolio of prescription ophthalmic products in the North American market. And Harrow's success rests on 4 pillars.

First, we're founder-led. Andrew and I are highly motivated by our equity and we're 100% aligned with our stockholders. We've personally directed every aspect of our growth from building imprimis from scratch to the last 5 years of acquiring about 17 branded products from companies across the globe. Second, our growing and profitable base business has been consistently fueled because Harrow is now the most active partner of choice in the ophthalmic M&A market, acquiring great assets at attractive prices, including the one that we announced this morning. Third, we have incredible people that we work with and they are executing.

Harrow is not a place to come to work if you want to take it easy. It's a demanding merit-based environment, which isn't for everyone. I never cap compensation because I never want to cap the level of effort and the value that our members of the Harrow family bring to the company. And then finally, fourth. While we love what we have, the future is white hot, bright with multiple new and exciting product launches on deck as well as NDA filings for large market opportunities coming in the fairly near term. In Q4, TRIESENCE and ophthalmic surgery next year by Clove and Bio vis, the following year, OpiaVIz and MELT-300, and who knows what else we have up our sleeves next. Harrow's purpose is clear.

We're in the ophthalmic disease management solutions business. Our products are not only safe and effective, but they're accessible and affordable to those who need them. They enhance patient compliance and ultimately improve clinical outcomes. Our portfolio covers a wide range of formats and therapeutic areas. We serve the entire spectrum of ophthalmic care. The anterior, posterior and ocular surface segments. We employ a disciplined acquisition approach. Over the last 5 years, you've seen us deploy modest amounts of capital to acquire assets that generate sustainable long-term value.

And we've paired our growth with a stable operating cost structure and a commercial platform that can scale with minimal incremental expenses. That combination plus focus, discipline and efficiency is how we're building and growing a profitable business that achieves our vision. And here's what the Harrow portfolio currently looks like today, including the therapeutic areas that we cover. Not bad from where we started from.

Now I'd like to comment on the very exciting news of our agreement to acquire MELT. MELT has the potential to transform not only ophthalmic surgery, but sedation for tens of millions of short duration procedures. Think about cataract surgery for sure, that is both IV and opioid-free. Did you know that in 2022, a study published in the Journal of Cataract and Refractive Surgery found that in a 2-year review of cataract surgery cases at Duke University, opioids were administered in nearly 97% of those procedures. A separate study of ophthalmic procedures at the Mayo Clinic found that Fentanyl was used in nearly 80% of cases. MELT will change this.

But why stop there? What about dental procedures, vasectomies, derm, plastics, GI procedures, putting in pacemakers, how about women's health and E&T. We believe there may be applications even in veterinary care. Did you know that about 1 in 4 patients who are in an MRI tube have claustrophobia and press the button to get out. We doubt they will if they have a MELT-300. MELT's patented technology is a game changer in these applications and others, and we believe MELT's product candidates are better for doctors, patients and the health care system compared to traditional IV sedation. And here's the key commercially.

For ophthalmic applications, Carol is in a unique position to bring MELT's lead drug candidate, MELT-300 to market because we currently sell a compounded version of the MELT-300. In fact, last year, we sold over 150,000 units to more than 700 accounts. We already have the relationships and the commercial infrastructure in place to nearly eliminate the launch risk for the MELT-300. With an FDA-approved MELT-300, we have a clear path to another $100 million-plus high-margin annual revenue product for our portfolio.

And we will, at the same time, dramatically improve, the surgical experience for millions of Americans each year. Conservatively, we expect to file an NDA in 2027 and launch in 2028. But hopefully, we can beat those dates. Building a great company isn't only about the financial results. It's also about celebrating the humanity of what we do. I am proud that we support ophthalmologists and optometrists who bring site-saving care to people in need on mission trips around the world. We are proud to have never ever turned down an opportunity to provide Harrow products to ophthalmologists and optometrists who are helping to give the gift of sight to our fellow brothers and sisters in the U.S. and across the globe.

In 2024, our products helped about 17,000 patients in 38 countries. And already this year, in 2025, we've helped over 5,000 patients in 18 countries from Honduras to Africa to the West Indies to right here at home. Harrow is helping restore vision, change lives and in turn, fuel our souls as human beings and our purpose as a corporate citizen. So when I say Harrow is the next great U.S. ophthalmic company, it's not just a slogan. In reality, we are creating this each and every day.

That said, we're going to fail. We're going to get things wrong, and we will learn from our mistakes as we always have. But over the long term, we have a fairly clear picture of what we can achieve. We have the portfolio to win. We have a platform, we have the pipeline. MELT is another example of how we're building to grow and rest assured, we aren't done. We also have the people. And today, I'm excited that you will meet other members of the Harrow leadership team. So in conclusion, I hope you'll agree that 77 years after Alcon and Allergan were founded, Harrow is now carrying the torch as the next great founder-led U.S. ophthalmic company, but founders aren't enough. We need the partnership of the Hero family and, of course, our stockholders. Together, it is a future that is white hot, bright. Thank you.

I always get to follow Mark and he's such a good speaker. It's always tough. Hey, everyone. Thank you for being here. I appreciate you being here, your trust in Harrow and our team. Today, I'm going to provide an overview of our business development process, I'm going to discuss our recent debt transaction, discuss our revenue history and 2025 guide, and I'll close out by laying out the road map for our fourth quarter 2027 revenue goals. Kicking things off with our BD activity. As many as you know, Mark and I lead our BD initiatives. That lets us move quickly, keep quality high and stay aligned with the long-term value creation. There's a simple framework we use.

First, strategic fit. We focus in markets we have a deep domain knowledge and strong conviction and we prioritize products that complement our existing portfolio. Second, financial discipline. We take a disciplined risk posture to our deals. We are selective in the processes we take on and use bilateral engagement whenever possible, with the goal of maintaining financial flexibility. Third, product and market profile, every product must have a clear pathway to payment. We target commercial stage and late-stage products, with clear differentiation and a straightforward integration pathway.

Fourth, we consider execution and integration. We take assets that scale efficiently within our infrastructure and we prioritize low integration risk and quick synergy realization. Finally, long-term value creation, we ask one question. How does this asset enhance our long-term growth trajectory by delivering durable revenue potential? This framework has helped us out with our current portfolio. and we expect it will continue to be an outline we use for future deals to come.

Moving on to our recent debt financing. We're very pleased with the outcome of this refinancing process that took place earlier this month. This transaction strengthens our balance sheet and positions us for the next stage of growth. By refinancing on improved terms, we lowered our cost of capital, which reduces interest expense and improves cash flow. Equally important, the refinancing extends our debt maturity profile, reduces near-term obligation and improves financial stability. Investors should view this as a signal of our strong credit profile and our ability to secure financing at attractive terms.

Importantly, we were able to achieve all 3 goals we sought for. Lower cost capital, increased flexibility and improved ability to pursue and close on BD opportunities. Here are some of the details. We issued $250 million of unsecured notes with a 5-year maturity and 8 and 5 days coupon rate. After paying the underwriters, we refinanced our existing debt stack with the proceeds. We also paid out all accrued interest on the debt -- on the old debt of about $4 million plus some exit costs. And when you include all of that, we netted about $10 million of new cash to the balance sheet.

On top of that, we announced a $40 million revolving credit facility that was committed by Fifth Third. This is going to carry an interest rate on drawn funds of SOFR plus 125 basis points to 175 basis points and an unused line fee of just 25 basis points. Between the revolver and the new cash, we now have $50 million of new liquidity coming out of the refinancing and our next interest payment isn't going to be due until March of 2026. Speaking of those interest payments, this refinancing reduced our cash-based interest expense by approximately $3 million a year. So taken all together, these moves improve our capital efficiency, they lower our risk and position us well to reinvest in growth and pursue attractive BD opportunities.

As a framing for our financial policy, Mark, and I want to operate the business at under 3x gross leverage and under 2x net leverage and expect to get there in the short term as we grow into our revenue plans. With the exception of 2021, our growth has exceeded 40% annually over the last 5 years. What's most compelling is that we remain in the early innings across all our major revenue drivers, which gives us significant runway ahead.

If you focus on the past 2 years following the launch of some of our key products, you'll notice one clear pattern. The second half of the year delivered stronger results than the first. We anticipate this trend continuing this year in 2025 as we look to hit our guidance of over $280 million of revenue. And last, let me walk you all through the pathway to the medium-term goal of $250 million plus in quarterly revenue by Q4 of 2027 and why we're confident in it.

First, we anticipate VEVYE generating about $75 million of quarterly revenue. This is going to be driven by the product's best-in-class attributes, continued new prescription growth and total prescription growth, which we are seeing no signs of slowing down for Q3. This is supported by the product's best-in-class refill rate, and we also anticipate gross to net improvement upon increased payer recovery for the product. a supply chain for this product stabilizes and a new manufacturing site comes online. We're going to have the ability, and we will expand the sales team and increased commercialization efforts around this important product.

Next, we expect our retina portfolio to contribute roughly $140 million by the fourth quarter of 2027. This is going to be driven by IHEEZO, which is we're going to leverage high reorder rates, clinical synergy with the biosimilars. And we saw this in Q2 where we showed a lot of growth in IHEEZO. We don't anticipate that slowing down. TRIESENCE is also gaining momentum in retina, and we are expanding into the ocular inflammation, its largest market in the fourth quarter of this year. We also plan on launching some important go-to-market initiatives in the fourth quarter that we think will help accelerate growth of this product. And then last, on the retina side, biosimilars. These are my favorite. BYOOVIZ and OPUVIZ target a very large market. In fact, it's the largest market within ophthalmology. These products both have interchangeability status with the reference products, and we have key customer relationships already in place.

When we launch, we will have a unique strategy in this market, and we think we'll be positioned strong to deliver meaningful results for both products. The next bucket is our surgical rare and specialty products, which we expect to deliver over $15 million of revenue in the fourth quarter of 2027. We have Bylovy launching in the first quarter of next year. This is the first novel topical steroid in the last 15 years to come to market in the ophthalmology space. We think our Harrow access for all program, which we announced yesterday, along with limited active competition here will be to our advantage as we grow unit volumes of most of these products, if not all of them, in addition to the revenue profile of all the products.

And last, as we look past 2027, we're confident MELT will add further growth, assuming a 2028 FDA approval. ImprimisRx is our last bucket here. This is our most mature business. It's where we started the company, and we expect it to remain stable, slow growth and continue to be a solid contributor of about $20 million of revenue a quarter. Now we won't get every line right. Some will overperform, some will underperform, but we do see a clear path as to these levels with the products we have. On the profitability side, we expect gross margins to be in the low to mid-80s, depending on the product mix and operating margins to be in the 30% to 40% range at these revenue levels. Thank you all again for your time today and interest. It's truly an honor to work for you all. And I'll now hand the call off to our next speaker.

All right. Good to see everyone. My name is Amir Shojaei. I'm the Chief Scientific Officer here at Harrow, and I'm going to walk you through some things that I don't think you've seen before, and that's mainly our pipeline products. There's a little background on me. So from a pipeline perspective, what I want to walk you through a little bit is what's our philosophy and how do we actually select products to put into our pipeline and where -- or how do we approach clinical development -- generally speaking, we look for derisked approaches, and we look for probability of success to be high, both in [indiscernible] areas.

So derisk in way of availability of data where we would not have to worry about clinical likelihood of success or regulatory likelihood of approval. And then Andrew already pointed this out, from a capital investment, we are very structured and disciplined. So we would want to be capital efficient in developing our products. And also, we use a shared risk model. So that said, we actually have specific milestones that have to be set in advance before we lay more in a way of capital input. So that said, these are 3 key pipeline products that I'm going to quickly review for you. One of the things that's important is we have organic growth of pipeline where it's mostly internally built. And then we also have inorganic where we actually have partnership with external collaborators. So you'll see a combination of that here.

With respect to MELT program, you've already heard the announcement this morning as well as the talk that both Mark and Andrew provided -- this is a very unique opportunity. It is indicated -- will be indicated for procedural sedation. The anticipated filing will be in 27 and the launch will be in '28. The other program is prefilled syringe of TRIESENCE.

This is triamcinolone. We call it from a coding perspective, HNO8. This is a product that's going to have the same exact label as the current TRIESENCE. However, it will come in customer-friendly presentation of it in a prefilled syringe. Why this is a unique product is also the fact that we will have a much more robust manufacturing in CMC. So the production of the product will be a lot more enhanced. That said, we anticipate a availability of that product in 2028. The last program that I have on here is called CR-01. It's a conjunctival delivery device. This is pretty unique. I'll go over it in a second, but this is for a specific ocular cancer indication that is a rare indication by itself. Currently, this stage of this program is in proof-of-concept study, which will be in cancer patients.

We anticipate that program if the data prevail to be in a launch mode in 2019. So one of the things I want to talk about MELT, you'll hear a lot more on it from Larry. But the way we talk about derisked asset. This is a classic example. You'll see that the FDA already had an agreement with the company with respect to what that Phase III should look like. And what's the likelihood of success if you do hit it. So they had a special protocol assessment in place where the design, the planned analysis, statistical approach, all of them were agreed upon and the company executed accordingly.

And the company. In November, you heard that you've seen the results were they've hit both primary and secondary endpoints. This already increases the likelihood of success. And from a submitability perspective of an NDA stance, we don't have concerns. What's next to do are some ancillary PK studies that we would have to complete, along with obviously compiling an NDA together and submitting. So we anticipate all of that to occur in '27. And the studies will be actually upon closing, but the submission will be in '27 with approval in '28, anticipation as well as launch shortly thereafter. The TRIESENCE program that I mentioned already, this is going to be a brand-new NDA. So from an overall work perspective, it will be a lot of effort. It will be a lot of CMC work to manufacture the product in a much more robust manner.

But from a label perspective, we anticipate the same label, the same wide indications that we currently have. However, we will be bringing it in a prefilled syringe, which is a lot more friendly to the docs. That said, we anticipate to do a pivotal visualization Phase III study as well as a PK study. This program is slated to actually be in an NDA submission mode by the end of 2027. So the CR-01, I alluded to this a little bit. This was a collaboration that we sort of got in with getting an option agreement to -- for the full U.S. rights of this asset with Dr. Humayun at USC and Dr. Tai at Caltech. This is really a phenomenal delivery device.

The picture is on here for you, but it goes into the lower conjunctival area and the patient could administer it. This is not an in-office administration per se. And they've already had tolerability safety study of this device. So that's already sort of passed the hurdle of sort of testing from our perspective. With that in hand, we're now going to be delivering this chemotherapeutic for a specific kind of ocular cancer.

Why we think this delivery device actually meets an unmet need is unique because we think with this prolonged slow release over a period of time, we could actually minimize the anticipated adverse events that the chemotherapeutic already creates. So we think in this way of delivery, we have a better shot of increasing sort of compliance overall with treatment and therefore, get a better outcome in terms of remission. So this is a unique approach.

We are going to have this tested in about a dozen patients ex U.S. And once that testing is done, we would get to actually see it exclusively from a data perspective and decide on whether we actually exercise our option and go forward. From a timing perspective, we anticipate that to be first half of next year. And from a layout from a capital perspective, we've only put in 250,000. So that's again another example of how we are quite disciplined, both in terms of de-risking assets in terms of success, but also in our capital layout for spend. So with that, I will pass the baton to Larry, and I'm not going to -- which are your last name. There you go

Thanks, Amir. Thanks to Mark and Andrew, for inviting me to present here, I tell you a little bit about MELT. The correct pronounciation of my last name is Dillaha. There will be a quiz at the end. So what we're working on at MELT, don't get that off the screen. What we're working on at MELT is an option -- to provide an option for both patients and physicians to avoid needles and opioids and procedural sedation. Our lead candidate is MELT-300. A fixed dose sublingual tablet of 3 milligrams medazilam, 50 milligrams of ketamine, 2 well-known molecules to the FDA. We exclusively in-licensed a technology from Catalent Pharmaceuticals called Zydis.

Zydis is already being used in over 35 NDA products. And once it's administered to the sublingual mucosa, it dissolves in 3 or 4 seconds. I have placebos in the back. If anyone wants to try it, I promise you they are placebos. And delivering a drug through the sublime mucosa allows you to bypass first pass hepatic metabolism. Some people get a little [indiscernible] with the ketamine molecule. The good news here is midazolam would be the anecdote or the reversal agent to any issues that can be seen with ketamine. We're at a pretty low dose of ketamine. We don't see any of that in our studies anyway, but to allay any concerns, medazolam is how they would treat that in the setting -- in OR setting.

We have a really good patent estate, 6 issued patents to carry us through 2036. We have patent -- ex U.S. patents in Asia, Australia, Canada, Europe, many of the -- most of the countries that pharma likes to play in. The initial target audience is cataract surgery. By the time this product launches, there's going to be over 5 million cataract surgeries done each year in the U.S. and $20 million done worldwide. But I really want to draw your attention to on this slide is the bottom right and Mark touched on this, but the label expansion is going to be really important for the product to really see huge upside. There's over 100 million procedures that MELT-300 could be used for.

They've already touched -- Amir has already touched on this before the Phase III study started, we requested and got an agreement on a special protocol assessment that Amir has explained to you. We are thrilled about this. As he said, it takes out some of the conversations that can go back and forth with FDA about did you do this right? Did you do that right? Those conversations are eliminated, that makes us excited. They agreed that would adequately address the objectives necessary to support a regulatory filing. It doesn't guarantee approval, but it does go a long way of helping things out. We also did a thorough QTC study and they agreed that we didn't alter any cardiac rhythm. This is the Phase III study.

We ran a Phase II study, which was 4 arms. It also had a ketamine alone arm in there. The results were very similar to what you see here from midazolam. But this is the Louis study, I believe, we're calling you now. And we ran over 500 patients through, and you see that the MELT combination beat both midazolam alone and the placebo. The placebo effect is real. It's amazing 1/3 of patients got through on just placebo, but the placebo effect is very real. Yes, this is -- we were excited to see these results. So -- and this, again, fulfilled the special protocol assessment. Very favorable safety profile generally comparable to placebo. We had no SAEs, severe adverse events, no discontinuations to adverse events and no clinically meaningful differences in electrocardiograms, neurocog functions or vital signs.

This product, we believe, is going to launch into a very favorable reimbursement environment. We believe is going to achieve and get transitional pass-through which would make it eligible as a separate payment outside the bundle. And there's other products. I think I know Harrow has 1 or 2 products that are doing that. But basically, you can charge average selling price plus 6%. And the average selling price has to exceed $510, I believe, is what last year's number was. You do this by requesting and getting a J-code under the HCPCS program, and that could drive long-term separate payment in certain medical settings. If by some reason, the J-code is not granted, we can also fall back to an S-code, which would allow for separate reimbursement as well. And I'll introduce Maggie, Dr. Maggie Jeffries.

Hi, everyone. Thank you so much for having me. I'm coming from Houston, Texas. And the most important thing to understand about who I am is that I'm uniquely positioned as an anesthesiologist who practices almost primarily anesthesia for ophthalmic procedures. That's a little unusual in my field where we usually are multi-specialty or in a hospital or in a ASC doing a lot of different types of surgery. Greater than 80% of my practice is all eye surgery all day, all the time. So I have more of an intimate knowledge of how not only the anesthesia works in an ophthalmic situation, but also the needs of my surgeon. I get feedback from the patients -- and so I'm kind of uniquely positioned to talk about procedural sedation in the environment in which MELT exists today. So a lot of questions that I get in the medical industry is why is sedation without an IV? Why do we care? Why is this interesting? Why is this different? Well, I always say, why not? Just because we've done something some ways for x number of years, doesn't mean there's not a different path forward. There's also a large push to move surgeries. Originally, it was let's move surgeries to ASCs, ambulatory surgery centers.

Now it's let's move them to the office. And CMS is underway -- undergoing a large push to move cataract surgery, even further into the offices. As they do that, that creates a very unique environment for us to be talking about not putting an IV in. Surgeons offices don't often staff nurses, they're able to staff cataract surgeries with just OD texts and OAs. And so these are not places that you're going to want to put an IV in -- it increases their cost burden and it also can slow them down and also decrease their profitability by having to hire more people to do these. So again, why not? Difficult IVs are also a real thing. It creates delays in surgical systems, that's lower efficiency, and that's money at hand, simply put -- so every time I have a difficult IV and more peak practitioners have to get called and the surgery is delayed, we're just losing money because time is money in an ambulatory surgery center and the faster we can get patients through. So we switch in my practice, most patients don't get an IV.

They get 1 when it's indicated. But if they can get through our surgery without an IV, we can just move them through the system that much faster. Patients really do have IV anxiety, even if they've had a lot in their life. And when they've given a choice, if you look at some data that's out there, they will choose oral or sublingual over IV. They're frequently not given a choice. So that's where we come in. We'd like to see that choice be given to patients going forward. There's also frequent and persistent drug shortages for the world of anesthesia and ambulatory surgery centers, I think every month something we can't get. It's not there. It's unavailable. We've never had a problem with our shortage getting our MKO melts. And the risk is very minimal with an IV, but there's still a risk.

We still get infiltrated IVs, large bruising, patients are on blood thinners. So there still is risk, although it is minimal and opioids are bad. There's tons of data out there. I was part of the consortium that published a large article about opiate use, opioid use disorder in ophthalmic surgeries. Two of those studies were quoted by Mark that are in our paper as well. it causes damage. And the studies out there actually have a one-hit theory that you get opioids 1 day in your life for one surgery and you're at risk for opioid use disorder. So imagine [indiscernible] surgery in are here for twice. So like it was said earlier, fentanyl is really used in the anesthesia environment to do procedural sedation. I'd like to see it eliminated for these types of procedures.

Why do we use sublingual. And why is it superior to oral? I get asked that a lot. Why not just a pill that you follow. It's actually an ingenious way to do it. First of all, dysphagia and malabsorption in the stomach is a real problem, especially in patients over the age of 65. So we bypass that issue. It also bypasses what's called the hepatic first-pass effect, where when you get a drug IV, it goes to your liver first and is broken down into byproducts. This goes directly into the bloodstream and bypasses that. You could give it nasally, but nasal mucosa actually has kind of a mimicked first-pass effect. So sublingual is actually quite superior and it's the most permeable area of the mouth. So when you're sublingually absorbing a medication, it's the closest to an IV route that you can get. There's nothing really better and you get a very good concentration of the drug, which the PK studies I have no doubt will show that the amount absorbed is quite close to the amount in the drug itself.

Midazolam and ketamine together are an ideal anesthetic. For those that don't know, Midazolam is a sedative. It's in the benzodiazepine family, so Valium is there, Lorazepam is there, Advan is there. They're all 1 big happy family. I always describe it as they're like cousins to each other. Ketamine is a drug that we've been using in anesthesia for I think it was FDA who approved in the late '60s. And it's anestic and it's also an analgesic. So it has properties to relieve pain and it also adds to the sedative effect of Midazolam. The 2 of them also have a very similar half-life. What that means is they're going to work together really quickly and then they're going to disappear out of your system around the same time. So you're not going to be left with the effects of one and not the other.

So their half-lives coincide really well. And when used together, the trend for surgical outcomes is better. I always like quoting an ophthalmologist I work with when millimeters count movement counts and patients with the midazolam ketamine combination don't move, and they're awake. And the opioids cause things like respiratory depression and all sorts of other issues and nausea and vomiting after surgery that I'm constantly having to combat. These 2 together don't do any of that.

So the expansion potential is significant. Most of my use is with ophthalmic procedures, but I do have an arm of my practice that does office-based procedures. I use the MELT all the time in offices. I like my practitioners to think about using it any time they have a procedure that's about under an hour that's in the minimal to moderate pain range, that, that is a medication they should be thinking about. If we're obviously doing a multi-hour painful surgery, this isn't the medication for that. But there are millions of procedures out there that it's suited for. Dental is a huge one. VEVYE used in colonoscopies, upper endoscopies with really good effects for patients who have phobias of general anesthesia, which is also a real thing that patients are afraid of.

We use it for patients who are having larger surgeries who have IV phobia for sedation. The irony of talking today is last night I got called by one of my ENT surgeons, about a patient that keeps canceling surgery that really needs to happen on their sinuses because they're so terrified of coming in and getting an IV. What can I do?

Well, sure bring her in and we'll give [indiscernible]. She'll be fine. We'll put an IV and no problem. So just having that ability, none of her other surgery centers had that. None of the other places that she wanted to take that patient was able to meet that need for that surgeon. So I'd like our surgeons to start thinking about, okay, I have patients with different needs. There's a medication out there. Let me take this to a place that uses this medication. So the real need for it and in cosmetic, we use it a lot for late facial lasers. There's laser procedures done on faces every day, all day, everywhere, and they're painful. Right now, the patients are just "suck it up butter cup" but this medication really takes the edge off and we use this for a lot of our patients undergoing minor facial procedures and oculoplastics like lelephoplasties, operations on lids for droopy eye lids, all of those types of things. MRI, I totally agree. Most patients just need a little bit to get them through. And with that, I will turn it over to Patrick Sullivan. Thank you.

Good afternoon. Great to be with you. My name is Patrick Sullivan. I'm the new Head of Commercial at Harrow. I just want to introduce myself. I'll tell you a little bit about me, good if I grab this. I've been in the industry about 25 years working across -- spans across large companies, midsized start-up organizations. I launched 20 products in the U.S., 20 products with about 60% of my time in the U.S. and about 40% of the time as ex U.S. I have deep expertise in commercialization launch planning growth acceleration and go-to-market across specialty medicines, rare disease and complex disease areas. I'm thrilled to be here with you today, to talk about the growth prospects that Harrow has in front of us.

Our commercial vision is clear, is to become the leading ophthalmic organization in the U.S. and the partner of choice to eye care professionals. Our strategy is centered on driving sustained growth on a consistent basis. And we'll do that by driving value of our expanding portfolio of branded products and being relentlessly focused on improving outcomes in the millions of patients that are out there. But notably, it is early days in our growth journey. There is significant headroom and opportunity for us to continually grow. And we're going to do that through commercial through our commercial excellence model by focusing on most importantly, having an agile work and unique model that actually drives value creation in the near term with our current products as well as as other products that we bring in through acquisitions and our R&D side. And this will require us having the best talent in the organization that will redefine the engagement with customers and also, most importantly, drive value on a regular basis across our entire portfolio to support our long-term and our near-term growth.

And when you hear about patient centricity, you can see this evident by our most recent announcement with our Harrow Access for all program. We are an organization that is very much focused on the idea of every, every patient, every prescription every single time because we know that when a doctor can write our product, they can get it, it will lead to a positive experience for patients that get Harrow products. Let's talk about the opportunity that we play in. The opportunities that we are right now currently playing in are large. They are well recognized, but they present significant opportunity. When you look at the dry eye space, just take a look, 16 million patients and only 8% of patients are optimally controlled. That presents significant opportunity for innovation. And in the retina segment, 20 million patients that have retinal procedures a year, and there are over 8 million procedures.

Again, presents opportunity for reliable supply and innovation. And in the surgical space that we're stepping into here in the fourth quarter and look forward to continual growth, over 7 million ocular surgeries in the year, and the majority of eye care physicians are trying to manage inflammation, which we can help with. And then as we talked about our rare and specialty products, these are a mix of everyday products that are out there that we want to make sure doctors can use where it becomes to antibiotics, inflammation and a host of other areas that present opportunity for patients. Key point here is these areas are well recognized. They are well understood, but there is significant unmet need that presents, and Harrow is well poised to close that gap and drive value and help many eye care professionals and their patients. So when you think about our commercial focus going forward, we have 4 areas of focus.

Let's just take a look at the dry eye segment. Our focus in the near term is driving depth where we've launched with VEVYE and continuing to grow depth among the doctors that have used our products. And then over time, leverage that experience among our eye care professionals to expand our use in other areas with other physicians and other practices. And we have a great team that's working on this that has a positive signs in early days. Retina, we know with retina that this is an account-based model where there are roughly about 2,000 accounts that are out there in the country. I think 1 of the things that is really important, we're employing a strategic account initiative to, one, make sure that our depth of our product goes across all of our accounts, our products are available and that we are getting ready for our next phase of our portfolio with BYOOVIZ and OPUVIZ in the surgical area, which we are calling a perioperative solution.

We are very excited about this as we step forward that has great prospects for growth. You'll hear more about this from Chad going forward. We have an opportunity in a portfolio that's emerging that will really surround that perioperative experience. And that is really valuable because we know that all of those stages, there are distinct choices that made, Harrow can be a tremendous solution there. And we again, this area exists, we are stepping into an area that has a low risk, and we're calling it a displacement strategy that ultimately we step in, we can assume a solution mindset. And our rare and specialty products. What's really exciting about our rare and specialty products is these are well-recognized products. And with our Harrow for all program and our strategy is taking place in the end of '25 and the start '26, is poised for growth for these everyday medications to make sure that the health care community can get these products. In closing, we are at an exciting point in our journey.

We are very confident in our commercial capabilities, our innovation pipeline, our products and our people to deliver on our commercial ambition. I'm going to pass this over to Maria Lloyd.

Good afternoon. I'm Maria Lloyd, I've been in the eye care space for over a decade. Thank you, Andrew. Appreciate that. I even launched the first cyclosporin back in 2003. I've worked in both large corporations and dynamic startups. My proven track record of success navigating complex markets has equipped me to lead this commercial team, making VEVYE the #1 dry eye product in the United States.

Before diving into are -- before diving into VEVYE, I want to take a step back and highlight the entirety of our dry eye portfolio. My role is centered around providing eye care professionals with the tools, resources and support they need to effectively manage our dry eye portfolio. We know that when providers have access to the right solutions, patients ultimately benefit from better care and better outcomes.

At Harrow, we have built a world-class dry eye sales team, one that is highly trained, deeply knowledgeable and fully aligned with the needs of the eye care community. The team is not just responsible for driving adoption of VEVYE. Their mission is to be a trusted partner to providers, ensuring that they feel supported and delivering the best possible treatment for patients. By combining a patient-centered access model and a best-in-class commercial organization, we are positioning ourselves to lead in the management of dry eye disease. We have created a sustainable ecosystem of -- that empowers providers to expand patient access and establishes VEVYE as a therapy to be the #1 therapy in this category.

Our vision is to become the #1 cyclosporine-based dry eye prescription in the United States. While VEVYE remains the primary focus and a significant growth driver for Harrow, we also have 2 other important medications that physicians rely on for dry eye management and interior segment inflammation, as you can see on the slide. FLAREX is approved for the use of treatment steroid-responsive inflammatory conditions.

Clinical data demonstrates that FLAREX resolved ocular surface inflammation rapidly and effectively with a lower risk of intraocular pressure elevation. FRESHKOTE is a preservative-free eye drop with design to support all layers of the tear film, offering patients relieve from dry eye symptoms, while also reducing further irritation. More specifically, FRESHKOTE addresses an evaporation stabilizing all 3 layers of the tear film, aiming to reduce tear evaporation, lubricating the ocular surface and also drawing excess water from epithelial cells.

Now on to VEVYE. VEVYE truly differentiates itself from other therapies used in dry eye disease. Why? It is the first and only wire-free cyclosporine approved for both signs and symptoms of dry eye, a distinction that truly sets it apart from all cyclosporin based therapies -- the clinical data is compelling. VEVYE's novel delivery vehicle has been shown to deliver approximately 22x more cyclosporine into the ocular tissue compared to RESTASIS. This translates into meaningful patient benefits, rapid onset durable efficacy lasting out to 56 weeks in a well-tolerated safety profile.

Nearly all patients report none or only mild installation pain. This is a critical factor in adherence and more importantly, long-term use. Look, the market opportunity is significant. Dry eye disease is both highly prevalent and undertreated while an estimated 37 million Americans sleep with this condition, only 9 million are currently on prescription therapy, we believe this treatment grab exists in the market. Because the market has not had access to a product that's truly effective, safe and differentiated until now. VEVYE directly addresses key unmet needs in this category, and it's uniquely positioned to expand the treated patient population while actually also capturing market share from existing therapies.

We are seeing that today. The market has actually grown over 20% year-over-year. For Harrow, this represents not only a key growth driver, but also a chance to reshape the treatment paradigm in dry eye. I'm not going to take you through every single line on this slide because it's a little bit of an eyesore. But I'll point to this. This is how VEVYE very clearly distinguishes itself from the competitors in this class, and it is hands-down tolerability. The data you see here is drawn from each product's respective clinical studies. While not head-to-head trials, they provide a clear picture of this competitive landscape. What stands out is that the most -- the most competitive products are associated with meaningful ocular adverse events, most notably, burning and stinging upon installation. Look, these side effects are not trivial. They impact comfort, adherence and ultimately treatment success.

In contrast, VEVYE demonstrates a highly favorable safety and tolerability profile. Nearly all patients report no pain or only mild discomfort during installation, which we believe it is a critical differentiator. This advantage positions VEVYE not only as a more effective treatment but also as a therapy that patients are more likely to adhere to long term. When considering the combination of efficacy, tolerability, durability, it becomes clear why we view VEVYE as a best-in-class option and a growth driver for Harrow.

One of our most significant milestones this year was the launch of VEVYE access for all, what we call VAFA, our patient-centric access model for VEVYE. VAFA makes treatment more accessible while streamlining the process for both patients and providers. We have already expanded this program to 2 additional pharmacy partners. This expansion meaningfully broadened Viva's distribution network, ensuring greater geographic reach, but also operational efficiency.

More importantly, it has significantly increased the proportion of patients who can secure coverage and begin therapy without unnecessary delays. VAFA is more than an access model, it's a strategic growth investment. We're driving stronger uptake, reinforcing our competitive positioning and ensuring that patients benefit from VEVYE's therapeutic profile.

Look, at the end of the day, this validates our vision aligning patient's needs with smart access strategies, accelerates adoption, it builds brand trust and delivers long-term value for our stakeholders. I'm very pleased with the success that our team has been able to execute on our primary strategic goal to make VEVYE the #1 prescribed cyclosporin therapy in the market.

In the second quarter, we took a major step towards this objective, reaching a 7.8% market share, and that was a strong increase of 2.6% increase from the first quarter in 2025, and it marks an important milestone. Why? VEVYE has officially surpassed Cequa in the U.S. market. Today, we stand as the second most prescribed cyclosporine-based dry eye therapy, and we continue to gain momentum. The progress we've made so far is just the foundation. We are still in early days of executing against our strategy and the opportunity in front of us remains substantial. More importantly, the momentum we've seen in the third quarter shows no signs of slowing down. This gives us the confidence and the strength and the sustainability of our trajectory.

When we look ahead, we know we're only scratching the surface of what VEVYE's potential can be. Market demand for innovative, effective solutions in dry eye disease continues to expand and our ability to drive broader access, stronger physician engagement and increased patient adoption positions us to capture significant market share over time. In short, while we are proud of the results we've delivered so far. We believe that the most impactful growth is still to come. With that, I'd like to introduce Dr. Paul [indiscernible] to the podium.

Paul received his doctor of optometry degree in Indiana University and completed his fellowship in medical cornea and refractive surgery in Kansas City in affiliation with the Pennsylvania College of Optometry, which is now called Salus University. He currently serves as the Clinical Director of Advanced surface disease at Kentucky Eye Institute in Lexington, Kentucky. He is one of the most highly sought after key opinion leaders in optometry. Operates one of the top dry eye clinics in the U.S. where he sees patients from all over the world. Paul, thank you for joining us today.

Thank you, Maria. Thank you for the opportunity to be here. Thank you, Harrow. And especially thanks all of you for being here. so many things going on in terms of your world, but I think you've made a wise choice. Yes. I think what I'm most proud of here beside my family is just I do think I have the largest ocular service disease clinic now in the country. I have over 550 [indiscernible] syndrome patients, see about 60 patients a day. So I live this every day and kind of trends that I get to see because I'm seeing about 60 a day seemed to follow through many times. And I put this first slide up here, just simply to kind of say 2 things. First of all, the fact that there's 3 million glaucoma patients in the U.S. tells us 2 things.

One, Dry eye is estimated to be about $38 million. So just putting things in perspective, and yet glaucoma is a significant part of eye care business. But number two, refractive surgery, contact lens wear, cataract surgery and digital device major contributors to dry disease and none of them are slowing down.

No one thinks that our digital devices are going to slow in any capacity and they're a big contributor to evaporative forms and other forms of dry eye disease. #1 reason for contact lens dropout and discontinuation is dry disease. And we've never gained traction because the number of patients that enter the market is about the same percentage of those that leave. So everything here is consistent with the world of dry eye and how it impacts everything we do in practice. Now symptoms are probably not new to many of you here because you've heard the kind of common complaints that go into dry eye disease such as difficulty wearing contacts, which we just talked about. But I really want to emphasize not so much the symptoms of dryness and irritated red eyes and GIs, but the impact it has on daily life and why there are so many people looking to get into that.

My clinic, I was talking to my staff this week, and they said, we're booking into early February. It's just the demand for dry eye because all we're talking about will only continue to grow. And what I'm fascinated before I talk about this is that, yes, there's 16.4 million people diagnosed with dry eye in eye care practitioner offices. But there's over $38 million that we estimate to have it. In some so you show 44 million that have the disease, we're underdiagnosing it. But the most telling fact is that only about 1.6 million are treated with therapeutics. It's a small percentage. I think Patrick showed the 8%, that's the 1.6 million people. And this is why this is so important. It's the reduction in reading capacity, work productivity, difficulty driving at nighttime, blurred vision affecting contact lens dropout, spectacle remakes, IOL miscalculations in cataract surgery, sensitivity to light and reduction in sleep quality.

And you don't sleep well, you get more dry eye. And if you get dry eye you get more difficulty in sleeping and that perpetuates over time, resulting in a lot of lost productivity and other issues. And it is progressive.

That's what makes this disease so important to get on top of and maintain treatment for an extended period of time. And that extended period of time is so critical because we've never been able to do it extremely successfully. We're finally starting to see that changing after many years. I started my first dedicated dry clinic. 27 years ago, I was trying to figure out when was that first day because I did 1 day on working with [indiscernible] Kansas City that was just dedicated to that. And it was 27 years ago at the end of this year. And we were limited in what we could do. We had steroids, which we still have, fortunately, today, that are critical.

We had punctal occlusion. We had artificial tears, and there was really nothing else. Today, we're so lucky, so many of our patients do well, and that's because of all of these advances. And this cycle of inflammation or the cycles called the vicious cycle of dry eye disease is so imperative to understanding what's going on and how we manage this disease. So we start often with things like hyperosmolarity. That basically means there's -- we have too much salt in our tears, not enough fluid, which is what dry eye by definition is. It could lead, obviously, or it could be caused by evaporation. You don't have a good oil layer because you use a digital device too much during the day, and you don't blink as often, the oil layer actually diminishes resulting in evaporation the rest of the layers and that could lead to hyperosmolarity or tear film instability, and it could go other ways too, the arrow could actually go either side.

Eventually, that leads to corneal damage. We call desiccation and I'll show you a case of that at the end. But all of it triggers inflammation and inflammation is the hallmark of so much of this disease. And so the goal today is really to try and focus on, I think, why we're getting it and controlling the inflammation. And sometimes that's devices and sometimes that's therapeutics and sometimes that's nutritional supplements, but they all work together in terms of allowing us to get a hold of this disease and manage it. This is not chat lips where you can put a little balm on there and hope that everything goes away. This is a true disease that's chronic and effects, as we said, close to 40 million people.

And being chronic, it leads to -- there's many different forms. There's an aqueous deficient form, the late and great Michael Lamp had a study that showed that's about 14% of the population. 34% of People have both forms of dry eye where their water glands aren't working well, their musin glands and the oil glands and then the large majority about 50% have oil deficiency. And we only expect that to increase because of the lifestyle we're in because of digital devices, because of activities, all the things that take place. But you'll notice they all trigger inflammation. There's never a time in my clinic where I'm not managing the inflammation as well as trying to manage the patient's condition at the same time. So that's the one component that's consistent amongst all forms of chronic dry disease.

So as I showed you this earlier, the way that we target currently dry eye in terms of clinical practices is through some devices in the office where patients pay to have those done. Artificial tears have been a mainstay. But if you talk to patients, they're limited. They don't last an extremely long period of time, but there's continuing to be a key role.

We talked to Maria who covered FRESHKOTE today, a very unique drop that works on oncotic pressure and helps in terms of the overall [indiscernible] tears to keep that tear layer in place. But what's fascinating by that artificial tears as a whole is, number one, they're still going to be important to utilize even though we're going to treat the inflammation. And number two, we're looking for unique ones like that, that stand out because there are a group of patients in my clinic that that's the only drop they can typically use. And we find those patients in all areas, even therapeutics where they are responders to certain agents and not to get in to the future, but AI is going to help us discover who are those patients ahead of time.

For now, we kind of trial them and see where they are. Nutraceuticals still play a role, but our prescription medications are the key that's where we focus on as clinicians. And how do we manage it from that standpoint, whether it's treating the ocular surface disease, dry eye, blepharitis, et cetera, those prescription medications combined with others. And I think part of the reason our clinic has done well is there's no panacea. There's no magic bullet. You really have to have the best of class, which we're talking about today in cyclosporine hands down with other things often. So I think our success came from knowing to utilize multiple treatments. Instead of having a patient come in trying artificial tears, bringing them back, putting them on hot compresses, bringing them back, putting them on a treatment, bringing them back, put them on cyclosporine they don't come back. You really have to start with the fundamentals that we know. But what's happened with cyclosporine over the year? What's happened with therapeutics?

This actually includes all the therapeutics. I was fortunate to be in both the studies published there as an author or co-author. And we analyze about 9,700 patients out of a database that were on dry eye medications to see how many stayed on their medications for dry eye. And so these were the more common medications at the time, the cyclosporin that were present and others. And what we discovered was, to some people surprising that only 3 people roughly out of 10 stayed on drops. It's a huge dropout rate. For a chronic condition without a treatment. These don't suddenly -- they don't stop because they get better. It's not that type of a disease. So it's a case of wondering, well, why did they not remain on a drop when disease only continue to progress when they're not utilizing these therapeutics. And we discovered a few things kind of stood up.

One was tolerability. Patients described it as being difficult to tolerate the drops it took too long for the results to happen. They couldn't stay with it. Number three was cost perspective. came into account depending on access. It was [indiscernible], but what was really unique about this was just the sheer volume that 7 out of 10 patients that I'm treating and others are treating stop the medication because it didn't do what they'd hope to do. So that sets the stage for something like VEVYE where we need a new form of cyclosporine to kind of carry us through there because it's not cyclosporine that doesn't work. The agent actually is very effective. In fact, at one point, the original 0.05% cyclosporine head of market peaked at over $1.4 billion. Patients were for the year. The patients did okay on these medications even though 70% discontinued it. So the drug itself, cyclosporin is very effective. In fact, it works at the heart of dry disease, something we call NF-kappa B. That for me is the way I put it is that's the core of inflammation. And when you can control NF-Kappa B, you control MMP-9, which are enzymes that could damage the surface of the eye, ICAMs that initiate further inflammation. They spring up off the ocular surface and they can add to more issues around cytokine production, which causes more inflammation, CD-147 were our macrophage activity, MPTP, which leads to cell death.

So point being cyclosporine, which came out in 2003, the very first form of this has been an effective agent. It's just the differences and the tolerability and long duration is key. So we need something in the cyclosporin category that's first and only. And this 1 really fits 3 levels of first and only. One is it's approved for signs and symptoms of dry disease. Every previous cyclosporin have been approved for increased tear production. Getting signs on there, but more so symptoms, I think, was really a key.

Second is water-free. That means a lot of things. That means there's no preservative, that means there's no pH that could burn or sting. It means there's no osmolarity effects that can cause hypo or hyperosmolarity to the eye. It's also dissolved in a semi-fluorinated alkane as part as the cyclosporine in this one. And so that's another uniqueness that adds another attribute because cyclosporine is not the most soluble agent. It's difficult to get it into the core of the drug. And so having a semi-fluorinated alkane seems to be the perfect fit for this drug. And that's what we're seeing here. It's called visual analog scale. Patients come into the trials and they say, 100 is the worst in capacity in dry eye symptoms I could ever imagine and 0 is the most comfortable I've ever been. This patient population started at a 70 out of 100. That's pretty significant symptoms. That's way up there in clinical practice. But you can see that within 4 weeks, that drops 22% improvement in self-reported discomfort in 4 weeks. That's a lot.

Remember, we talked about the reasons the other drops, 7 out of 10 people dropped out of them. This was one of the reasons because it took too long to work. You've got 22% significant drop from 70 to 54 as soon as 4 weeks. That only continued to be a 38% reduction by the time you got to 56 weeks in this patient population. And so that's the kind of results we want. Not so much the long duration that it continued because that is important, continue to improve, but also the fact that it had such a significant effect quickly at 4 weeks.

Patient symptom also improved. So while it's nice to see in my clinic, the signs of dessication improving, and we're seeing numbers like smart proving ultimately for most clinicians and for most -- for all patients, symptoms are what they look to. And this was a factor. If you look at that dropout study, one of the big reasons that went to that 7 out of 10 dropping out was that they didn't see symptoms improving quick enough for what they were doing. So these symptoms in the 50-week study, if you took the patients who had 3 or more grades of improvement in total corneal fluorescein staining, and that's where you look for dry spots on the eye or breakdown areas on the surface called desiccation. Those patients saw statistically significant improvement in 6 out of 8 measures as soon as day 29. And you can see those there because that included things like awareness of dry eye, reading speeds, digital device use, something we do all the time, you especially do a lot of fluctuating vision, driving at night, et cetera, all impacted in that time.

But the biggie that we talked about, the big issue was that was tolerability. Could patients continue on drops if there was a high percentage of burning and stinging or other side effects they had to deal with. This is probably one of the biggest slides I could put up, 99.8% of the clinical trial patients experienced no or mild installation site pain. And I see that in clinical practice. And it's so wonderful to be able to use drops now where I don't have to -- I still educate them, this can happen, but where I'm not dealing with having them -- trying to keep them on the drops longer trying to maintain them because I know the effects they'll get if they can stay on their drops.

We'd rather just prescribe something, see this type of response and I know the medication is going to do it at slide showed. I'll leave you with a good example. And actually, this case does not want to mine. This is for a colleague of mine in Kentucky, a good friend, Dr. Ben [indiscernible] who sent in a patient 56-year-old white female. This was at the very beginning. And at the very beginning, you're taking patients where they've tried everything else. That's just naturally what you do when a new drug comes out. So have been back a little -- a couple of years now, 1.5 years. And so what we're looking at is this patient who had been on all other medications, preservative-free lubricant eye drops currently on flax seed oil, which is nutritional one, which is, of course, is brave for allergies through the nose.

Preservative-free lubricating appointments at night time. You can see the vision isn't great 2025. It's not quite stable. When you get numbers like that, and she has a lot of symptoms. When you get a score of 21 out of 28 on a speed, that's about as high as they get.

It's very hard to get beyond 20s in this type of a questionnaire before going in. So a highly symptomatic patient presented with a lot of treatments that didn't work. And if you look to the -- in your case, your left, that brighter green are the dry eye spots are called dessicated stress or dessication or breakdown on the surface. And we put fluorescine in, we can light them up. And those are dry spots we look for. And if they get really advanced, they become what we call Confluent, they kind of coagulate, they connect together the dots individually. And you can see that even though the patient could correct to 2020, it wasn't good quality, and that's the hallmark of dry eye disease. The patients who say, if I blink, maybe I could see a little bit better.

I've got pretty good vision when I test, but I really don't see all that well, and I can't drive at night like I used to, but the quality of vision is affected. And this patient not only was able to completely be rid of the staining pattern, which is difficult to do. Typically, I often have to use steroids. FLAREX is an ideal steroid for dry eye disease, especially those with mucin deficient components of dry eye. Those types of steroids do extremely well. But we never thought of maybe an immunomodulator like VEVYE doing that.

So most times, I'll have to use both, but in terms of the patient presentation, but this 1 is purely just VEVYE and at 1 month. Not only did the patient's desicative signs go away they got back into contact lens wear, the number one reason for dropout we talked about early. And if you look at the other eye beforehand, you can see, again, good vision on testing, but not good quality and then look at the difference at 1 month being on VEVYE twice a day. So this patient now could resume contact lens where -- so it is an exciting drug to get to talk about. It's just 1 that's made a huge difference in my clinical practice. So when I was invited, I was honored to be able to present on it and to be able to show the clinical signs to understand where the history has taken us and to look at where now we're going in the future and the impact it will have on our patients.

With that, I'm going to bring up our -- the Chief staff to the CEO to come and present next.

Thank you all for being here today. It's great to see such a strong turnout. My name is Prashanth Annavajjhala, and I serve as Chief of Staff to our CEO, Mark Baum, while I'm a physician by training and come from a family of ophthalmologists in my native India. I've always gravitated towards the business side of health care, which led me to complete my MBA at Rice University in Houston. I now have over a decade of experience in market access, health care strategy, product commercialization within the pharmaceutical industry with a particular focus on ophthalmology. Over my career, I have led product launches, shaped market strategies and driven cross-functional initiatives at organizations such as Regeneron and Aventure.

In addition to working closely with Mark on various initiatives and passionate about developing strategies that unlock growth and enhance patient access. I'm excited to bring my perspective into today's discussion. As I have played a key role in shaping our VEVYE access for all our HAFA program, I'd like to share how that works. We have partnered with 2 specialty pharmacies [indiscernible] and Apollo Care who currently support VEVYE access for all. Importantly, we remain flexible and agnostic to the number of pharmacy partners we work with, provided they align with our business and economic rules. Think of the program like a funnel. When a patient is prescribed VEVYE, that prescription is routed either through [indiscernible] or Apollo Care. From there, the pharmacy determines whether the patient is covered by insurance.

If the first pharmacy in this case filled is unable to secure coverage. We can seamlessly redirect the patient to the other pharmacy, maximizing the number of patients who ultimately gain coverage. At the bottom of the funnel, if coverage is still not secured, eligible patients can access VEVYE through a simple, affordable cash payoff option of just $59. This approach ensures that every patient who has been prescribed VEVYE has a clear accessible path to treatment, whether through insurance or affordable cash paid. The key to success is ensuring both prescribers and patients have the best possible experience. We achieved this by working with Harrow pharmacy partners and their networks, which follow VEVYE access for all business rules.

As the coverage expands, more VEVYE prescriptions will be filled at a premium pricing, extending to all refills and driving growth in net price per product. Building on the success of VEVYE access for all, we were excited to announce yesterday our new Harrow access for all our HAFA initiative. I've been deeply involved with Mark in shaping this patient-centric access strategy. And I'm thrilled to walk you through it today. The vision of Harrow access for all is to unify our branded, generic and compounded ophthalmic medications under a single user-friendly platform. Our exclusive partner in this program is PhilRx. For prescribers, Harrow Access for all provides a seamless one-stop solution, essentially the Amazon of ophthalmology, where they can access the full range of therapies they need at affordable prices without friction.

Through this program, eligible commercial patients may pay as little as $0 with a maximum amount of pocket cost of $59 across our entire portfolio. Mark's vision was very clear. ensure patient access to affordable medications while maintaining a reasonable attractive profit for shareholders. Harrow access for all will launch in 3 phases. Phase 1 is in the fourth quarter of this year, covers most of the specialty portfolio and eligible patients pay anywhere between $0 to $59. Phase 2 will be the first half of 2026, where Harrow generics would be added at the same pricing, which would improve adherence and market capture. Phase III would be in 2027, which would expand to our full portfolio. which includes specialty, generic and compounded, creating a fully integrated access platform with durable competitive advantage.

The Harrow access for all portal is more than a market access program. It's an ecosystem that expands market presence, drives recurring revenue and deepen relationships with physicians and patients.

Beyond revenue, the true advantage is the service. Harrow access for all provides physicians a single integrated solution to manage prescriptions, refills, order tracking and patient needs. The white glove experience reduces administrative burden, strengthens physician loyalty, improves patient satisfaction and positions Harrow as the trusted partner across the prescribing journey. To close, VEVYE access for all delivered a 66% increase in prescription volume in its first quarter with nearly every prescription being profitable, a dramatic improvement from pre-VEVYE access for all performance.

This proof of concept gives us confidence that Harrow access for all will follow a similar trajectory, driving faster adoption of our products and expanding Harrow share across the portfolio. Most importantly, VEVYE access for all and Harrow access for all ensures that nearly every script is profitable, fundamentally strengthening our economics and positioning Harrow for a sustained profitable revenue growth. We expect to see the initial impact of Harrow access for all in the first half of 2026.

With that, I'd like to turn over to Chad Bryant, our VP of Surgical portfolio.

Good afternoon, everyone. Thank you, Patrick I'm absolutely thrilled to be here today. I recently joined Harrow as Vice President of the Surgical portfolio. My charge was clear. Delight ophthalmologists with our suite of perioperative disease management solutions and build a dominant presence in this important market. It would normally be pretty intimidating to be in a room full of this many savvy intelligent analysts key opinion leaders and just amazing professionals. But exactly 2 weeks from today, I'll be delivering a speech at the wedding of my youngest daughter, it already chokes me up just saying that. So in comparison, this is actually pretty low pressure quite frankly, there is much less chance of me crying today, although we'll wait and see how the Q&A session goes before we have that full conclusion.

I'm excited to bring more than 20 years of experience in the medical device and pharmaceutical industries with leadership roles at Novartis, Stryker and Johnson & Johnson. In fact, most of my career has been in some form of a surgical area. Most recently, during my time at Ocular Therapeutics, I led the successful execution of the go-to-market strategy for DEXTENZA, a postocular surgery steroid. At Harrow, while recruiting the ocular surgery team, I am frequently asked why I joined the company. The answer is simple: to build something great, a great team, a great franchise and a great company, all of which is enabled by the entrepreneurial spirit of the company, its founders and the focus on innovation and accessible and affordable eye care solutions.

Look no further than this morning's announcement. My immediate priorities are clear: Number one, expanding TRIESENCE into the ocular inflammation market starting in Q4; and number two, driving the launch of [indiscernible] in the first quarter of next year. Let's start with the opportunity. The ocular surgery market is 1 of the largest and fastest-growing segments in the entire eye care industry. Each year, more than 7 million ocular surgeries are performed in the United States alone. And of those, cataract surgery procedures represent the vast majority, over 5 million cases annually. In the ocular surgery market, a large focus of our efforts will be on the cataract surgery segment.

The growth in this segment is driven by aging demographics, the rising prevalence of vision impairing conditions and innovative and innovations in surgical techniques, including minimally invasive glaucoma surgery, intraocular lenses and advanced laser platforms. Harrow is uniquely positioned in this environment. We are strategically focused on delivering a robust and differentiated portfolio of medications that serve the surgical continuum before, during and after procedures. This isn't just about individual products. It's about delivering comprehensive solutions for our customers, surgeons, practices and patients in one of the most critical areas in ophthalmology.

As we have built a world-class surgical portfolio, I would like to highlight the focus of our strategy. The main priority is clear, to successfully launch and establish TRIESENCE [indiscernible] and eventually the recently acquired MELT-300. These 3 products form the backbone of our surgical portfolio. They represent differentiated solutions that meet the pressing needs of physicians and patients and will be the central focus of our commercial execution over the next several years. At the same time, we are ensuring that we maximize the value of our complementary portfolio, including products such as Allergan and Nevanac.

While not the core drivers, these assets are strategically important because they complement our primary launches and allow us to deliver a more complete and robust offering to surgical practices. By providing physicians with a broader toolkit, we deepen relationships and strengthen Harrow's position as a trusted partner. The combination of products supports a balanced strategy. One that builds immediate momentum with [indiscernible] and TRIESENCE while sustaining long-term growth and differentiation with a comprehensive portfolio. As I mentioned at the outset, our goal is to provide physicians with a comprehensive perioperative solution for the surgery market. Let's take cataract surgery as an example. A patient must go through several steps for a successful procedure.

First, the patient needs sedation. Here we can offer MELT-300, a non-IV non-opioid option. Next, after surgery, inflammation must be managed and physicians have a choice between [indiscernible] TRIESENCE depending on whether they prefer a topical or injectable steroid. We also have Allegro and navsnsc should they prefer in NSAD as well. By integrating these solutions, we're making Harrow an essential partner across the full surgical journey. Ocular inflammation resulting from surgery represents the single largest market opportunity for TRIESENCE. In the United States alone, based on procedure volume, cataract surgery remains the most frequently perform surgical intervention each year.

The number of cataract surgeries in the United States is projected to increase to nearly $6 million annually by 2030, driven by demographic trends, and advances in surgical techniques. I am truly excited about this expansion with a clear focus on positioning TRIESENCE as a first-line treatment for ocular information in patients who do not respond adequately to topical steroids. Unlike many alternatives, TRIESENCE is FDA-approved fully on-label and preservative-free, providing a safe and effective option that physicians can trust. Equally important, TRIESENCE offers compelling economic advantages.

It is the most affordable FDA-approved injectable ocular steroid with patient out-of-pocket costs as low as $37 under both government and private insurance plans. Coverage is exceptionally strong with nearly 96% of patients already covered and only 6% of those requiring a prior authorization. Moreover, TRIESENCE is reimbursed across all traditional care settings, ensuring broad accessibility. From a clinical standpoint, TRIESENCE eliminates the challenges associated with steroid eye drops. There's no need for patients or caregivers to administer multiple daily doses, which improves compliance reduces the risk of complications and ultimately lowers the overall postoperative burden.

This combination of clinical benefit, affordability and broad access positions TRIESENCE as a differentiated and highly valuable treatment option in ocular information. Now let's turn to [biclovy]. This is the first novel FDA-approved steroid to enter the U.S. market in more than 15 years, 15 years. It represents a major advancement in postsurgical ocular care, approved to treat inflammation and pain following surgery by Clove offers a differentiated solution for both physicians and patients. Aside from its unique and patented delivery vehicle, what sets [biclovy] apart is its use of clobetasol, making it the only ocular steroid to harness this highly potent molecule. As a result, [biclovy] is the most powerful steroid on the market, yet it has demonstrated an impressive safety profile in clinical studies with a low incidence of intraocular pressure, elevation and outcomes comparable to placebo.

This rare combination of potency and safety provides physicians and surgeons with the tool they have been long waiting for. [Biclovy] also offers patient-friendly BID dosing for only 2 weeks. We are preparing to launch [biclovy] in the first quarter of 2026, and my current focus is on executing all key prelaunch activities to ensure a strong and successful introduction. With more than 7 million ophthalmic surgeries performed annually in the U.S. a number that continues to grow. We see a substantial market opportunity ahead, and we are confident [biclovy] is well positioned to capture meaningful share in this large and expanding segment. Execution will be critical, and we are investing accordingly. The first phase of recruitment is complete, and we are ready to take root in the fourth quarter with the expectation of being fully mobilized in early 2026.

In addition to being asked, why I joined Harrow, I'm regularly asked by candidates, what's the vision for the surgical team. Where is this franchise going within Harrow? I'd like to paint the picture that 12, 18, 24 months from now, when an ocular surgeon has a need for a pharmaceutical product related to surgery, the first company they think of is Harrow and the first portion they think of as their Harrow ocular surgery account manager. Quite simply, we will become the Amazon of ocular surgery Pharmaceuticals.

This begins with the expansion of TRIESENCE into occular information in Q4 of this year, and we anticipate seeing the initial impact in early 2026. Layered on top of that, the launch of [biclovy] is expected in the first quarter of next year. With experienced leadership and a laser focus on this branded surgical portfolio, combined with a specialized, highly experienced all-star commercial team, we will have the right foundation to drive adoption and revenue growth. We expect the impact of these efforts to be visible in the first half of next year, setting the stage for durable growth in the years ahead.

In summary, Harrow's commercial surgical build-out ensures that our innovative products reach the patients who need to. Thank you.

Please welcome to the stage, [indiscernible] Harrison, VP of our Retina portfolio.

Thanks, Chad. Thanks for giving me the opportunity to speak today. Andrew, Mark. My name is Allie Harrison, and I am the VP of the Retina portfolio for Harrow. I'm really excited to be here today to talk to you about some of the things that we're going to be building out in the retina franchise with Harrow, some of my experience. But really what I want to get into is the meat of why we're here and what I'm going to be talking about today. So let's begin with the big picture with Harrow.

So Harrow right now is redefining retina care by building out the largest and most comprehensive portfolio in the market. So retina disorders like macular degeneration, diabetic retinopathy, DME represent millions of patients worldwide and represent one of the largest areas in ophthalmology in the U.S. Our strategy is straightforward, empower physicians with the tools they need and expand access for patients would depend on vision saving treatments. The infrastructure that we've built is also very unique. It's not just about a single product, but about a platform that's designed to continuously fuel acquisitions, launches, and innovation in the retina space. We are prepared and ready for what Mark and Andrew brings to the table. Perhaps most importantly, though, this strategy is being executed, but what I would call the best team in retina.

And I think our physicians would agree. So we're ready to take on what we're going to be bringing on in that level of expertise means that we can anticipate physician needs. We can navigate complex reimbursement situations and bring solutions to the table that are clinically meaningful, commercially scalable and really coming to the table with a problem that's being solved. So Harrow is not just investing in products. We are investing in the future of retina care. So innovation and retina is not just about products, it's also about patient access, which is extremely important in our world. So earlier this year, we launched our Harrow Cares hub in partnership with Syncora. This hub is a one-stop reimbursement and patient support platform that ensures practices feel confident in prescribing our products.

It handles benefit verification, patient co-pay assistance, prior authorization navigation and denial support. For physicians, this removes the administrative burdens and barriers that often discourage adoption of new therapies for patients, it means greater access and affordability. The impact is significant. Instead of being limited to the Medicare fee-for-service patient population, this allows us to expand into the commercial and med advantage patient population. This means that every patient now that is getting in need of a retinal procedure is now able to get access to our products. IHEEZO is a perfect example of what we're doing in retina and innovation. We are the first branded ocular anesthetic in the U.S. in nearly 14 years. It addresses over 12 million ocular procedures annually.

So what makes IHEEZO unique?

First of all, it acts rapidly within 90 seconds and will last about 22 minutes. Second, patients experienced less pain scores than tetracaine, and that's a very important differentiator for physicians. Third, it provides sufficient anesthesia throughout the entire procedure, so they don't need supplemental anesthesia. And finally, it is the only reimbursed product of ocular anesthetic on the U.S. market. IHEEZO's intellectual property is also very strong. It has 2 patents in the Orange Book that go through 2039. And taken together, these attributes position IHEEZO not just as an alternative, but standard of care for ocular surface anesthesia for years to come. Mark has asked me whether or not we can capture 10% of the market over the next couple of years.

And I believe, although no result can be guaranteed with the team that we have in place, we can hit that target. Shifting to our commercial focus in 2024, we announced the retina pivot where we focus our efforts on the retina community and the physicians doing intravitreal injections. This was the right pivot. The majority of new accounts that we're seeing come into Harrow right now are retina based practices that are implementing IHEEZO across their practice. We now have agreements in place with all 4 of our GPOs, group purchasing organizations that service the retina community.

And earlier this year, we also announced the IHEEZO access for all. This is a strategy to drive a physician education, accelerate IHEEZO adoption expanding its use across all righter procedures in both established and new accounts. On top of that, IHEEZO has 92% coverage across both commercial and government payers, which is remarkable for a product only a few years post launch. The small remainder of claims are either not covered or require prior authorization. So we are actively addressing those issues. For practices, the benefits are clear: a standardized, efficient anesthetic protocol that reduces time per procedure, lowers staffing demands and empowers throughput and Finally, our biosimilars portfolio creates powerful clinical and economic synergies with IHEEZO. Every intravitreal injection requires a topical anesthetic.

And that makes IHEEZO an essential and wonderful complement to biosimilars like BYOOVIZ and OPUVIZ. As these biosimilars launch, we expect to be a catalyst for the further adoption of IHEEZO. The value extends beyond the clinical setting. Together these products drive efficiency, reduce procedure costs and create scalable economic benefits for practices.

In short, IHEEZO is not only a best-in-class an aesthetic. It's also a growth engine and a better business solution for retina specialists. So I think you're all aware that the backbone in the retina space for treatment is the anti-VEGF space. And now Harrow is well positioned for 2 best in class similars. We recently entered into an agreement with Samsung Bioepis, a global leader in biosimilar development to acquire the U.S. commercial rights to both BioViz and OpuViz. BYOOVIZ, the first FDA approved Lucentis biosimilar is on track for U.S. launch in mid-2026. OPUVIZ and EYLEA biosimilar is expected to launch in the second half of 2027. Both products carry interchangeability status giving them a critical commercial advantage.

What makes these assets so attractive is how they complement our existing portfolio. They integrate seamlessly into our commercial infrastructure aligning clinically with IHEEZO and TRIESENCE. And together, they create a holistic offering that few, if any of our competitors can match. So let's take a closer look at BYOOVIZ. In 2024, Lucentis accounted for approximately 680,000 units and compounded Avastin was about 2.5 million units and biosililars just over 350,000 units. So clearly, there's a huge opportunity here for a safe, reliable, cost-effective alternative, and BYOOVIZ provides exactly that. It's FDA approved, interchangeable and manufactured in the U.S., ensuring a reliable supply chain. It also carries the largest Phase III data set, giving physicians confidence in both efficacy and safety. The competitive landscape is relatively limited right now with only 1 other FDA approved biosimilar for Lucentis on the market.

That means that BYOOVIZ is well positioned to capture a meaningful share from Lucentis component Avastin and other biosimilars in the years ahead. Now let's turn to Acutus. As I'm sure you're aware, OPUVIZ EYLEA biosimilar, and that also creates a very large market opportunity for us. In 2024, EYLEA represented approximately 2.5 million units. EYLEA HD brought in about 850,000 units. [indiscernible] brought in 1.4 million units. And against that, the biosimilar bought in around 425,000 units. So again, OPUVIZ is clinically validated, FDA-approved, interchangeable manufactured in the U.S. And like BYOOVIZ, it offers consistency, safety and predictable pricing. Its differentiated profile and go-to-market strategy position it to capture share, not only from EYLEA, but EYLEA, HD and other new biosimilars coming to the market. This is an enormous market.

And OPUVIZ gives us a seat at the table with the product in both that is both competitive and durable. So let's take a closer look at what this potential can look like, looking at what Pavblu has been doing in the past year. In the first -- and this is the first biosimilar to hit the market. The first 2 quarters that launched Pavblu brought in around $225 million in revenue and is on track to bring in $500 million for the year. This is a powerful proof point that biosimilars can bring -- capture meaningful share once they launch. As EYLEA's patents expire in 2027, we expect multiple biosimilars to hit the market. The lesson from Pavblu though is clear.

When physicians trust the product and the supply chain is reliable. Uptick can be swift and revenues substantial. I'm not saying that our biosimilars will follow that same trajectory. But I believe both BYOOVIZ and OPUVIZ are well positioned in the market supported by Harrow's infrastructure and relationships. And it's important to emphasize to you that Harrow has got a little bit of a different approach when it comes to its competitors. Many biosimilar players view the market like generics. Competing almost exclusively on price, which inevitably drives erosion and undermines the long term value of the product. Our approach is going to be different. We are focusing on patient value, trust and durability. Both BYOOVIZ and OPUVIZ come with interchangeability status and were developed by Samsung Bioepsis which is important in the biosimilar space. It's a trusted source that they're coming from.

Together, Harrow and Samsung bring reputations for quality and stability that matter deeply to physicians in ophthalmology or disease -- with diseases that are site threatening, trust is paramount. Physicians prioritize products that they know deliver reliable outcomes.

Our strategy allows us to sustain healthy average selling prices and avoid the race to the bottom, building a durable business in a competitive environment. We don't plan on being here in the short term, we want to be here for the long term. And we're going to be having -- leading the retina franchise in the U.S. So finally, let's talk about TRIESENCE. I know Chad touched on that a little bit. We're going to complement each other very well. TRIESENCE, again, the only FDA-approved preservative-free criticosteroid in the market with unique reimbursement areas and advantages in both the surgical, which is Chad's team and then the nonsurgical the in-office setting. In Q2 2025 alone, we're getting some great momentum. TRIESENCE added in 870 new accounts, delivered 32% quarter-over-quarter growth and the ban in the first 2 months of Q3 has already exceeded what we brought in all of Q2.

And looking ahead, Chad and his team are expanding into the ocular inflammation market and which is the single largest market for corticosteroids, but our retina team in bringing some good numbers too. We believe strongly that our team with retina will drive significant unit demand in Q4, leveraging the work that we put in place all year long. It's also worth noting that the next-generation version of TRIESENCE which Amir noted we'll be ahead of the development of that will be ahead of its 2029 patent expiration, securing long-term value. So with the stable supply chain, strong reimbursement and a clear pipeline, TRIESENCE is set to remain a cortisone of the retina franchise.

So to close, Harrow is building a comprehensive durable and high-value retina franchise with Harrow from IHEEZO's innovation to ocular anesthesia to biosimilars that will reshape the anti-VEGF market to TRIESENCE growth of Retina, our portfolio is broad and synergistic and that makes us very unique in the retina space. And who knows what Mark and Andrew have up their sleeve to add next to our commitment in this market. We are focused on expanding access, supporting physicians, delivering better outcomes for patients and we're doing so with -- like I said before, I think the best team in retina. We have a great infrastructure, and we have trusted partnerships with our physicians. This is how Harrow will not only participate in but lead the next era of retina care.

I am extremely pleased to have 2 reknown positions with us today, Dr. [indiscernible] Patel, both are nationally recognized leaders in the field of retina care. Each brings deep clinical expertise, extensive real-world experience with Harrow's retina portfolio. Their perspectives are really going to be available because they not only understand the science and practice of retinal disease, but they also first firsthand know our products, how they're impacting patients, practices and the treatment landscape. We believe their insights will provide important validation for our strategy, highlight the differentiation of our products in the marketplace and growing adoption we are seeing among leading specialist.

So now I get to introduce Dr. Raj Patel, I'm going to try to go through this quickly. There's a lot there, but he is an expert in retinal diseases, both wet AMD, DME, DR. He has specialized training in vitreoretinal surgery, and he did his original fellowship -- thank you. He does undergraduate to gate Northwestern University, he went to up team is a Master of Science degree and to Lane and state in Louisiana to complete his medical journey at the [indiscernible] University School of Medicine. He then continued on with his internship at the Reading Hospital and Medical Center in Pennsylvania and Dr. Patel then returned to Tooling to finish this ophthalmology residency and they went on to complete this fellowship program in vitro retinal surgery at the University of Chicago under none other than Dr. [indiscernible]. So please welcome Dr. Raj Patel.

Thank you for that kind introduction, [indiscernible]. As far as where we'll start, I kind of wanted to set the stage of kind of the problem that this product is solving. And as we know, the American population is aging. This is due in large part to a lot of different factors, but one of which is the significant advancement of medical care. These gains, however, are a bit of a double-edged sword and that as people are making it to later ages in life, they're developing a host of retinal conditions that require consistent care in order to maintain vision and therefore, maintain a good quality of life. And nothing is more important than quality of life. And I think a lot of the products harrow brings kind of reinforced that, and I'll kind of come back to that at the end.

The mainstay of these treatments is intravitreal injections to treat macro degeneration, diabetic retinopathy, retinal vein occlusion from hypertension amongst a host of other diseases. In addition, the advent of new therapies for previously untreatable conditions like geographic atrophy, a subtype of dry macular degeneration, require injections on a monthly or every other month sort of schedule. All this to say that the number of intravitreal injections done in the world is rising and will continue to rise as this trend continues. So the question is with this increasing need of intravitreal injections, there's more conditions that are being treated every year. How can we do this better? I'm not ever one to just stay the same. I always want to bring an advantage to my patients.

I want to improve their quality of life, as I said. And so how do we best perform these treatments very carefully is my answer. But in all seriousness, there are a lot of different choices and each have their advantage and disadvantage. And before getting to IHEEZO, I just kind of wanted to walk you all through what's out there currently because I think it will help you better understand what IHEEZO brings to the table. So kind of the gold standard would be using topical drops, okay? So just preparicaine or tetracane drops. These are pretty much in every single ophthalmologist office in every single exam lane. The reason that was the gold standard is because they're everywhere. It's relatively cheap. They're not a barrier to antisepsis or killing the germs on the surface of the eye because it's just a liquid.

The disadvantage here is that while they work quickly, they don't work very well. And so injections done using just topical drops hurt, quite frankly.

I mean, it's not something that you're going to sign up to do again, typically, okay? As a result, surgeons started to look for other options. And so a lot of folks started using cotton pledgets or cotton tip swabs, basically a Q-tip soaked in lidocaine and then it's placed in the injection site. And most of these injections are done kind of in the white part of the eye, the upper outer corner or the lower outer corner. And so as you can imagine, putting a piece of cotton there, it can irritate the lining of the eye. And after the treatment, it can lead to soreness. Also, you have to leave that lidocaine there for a period of time. As you can imagine, an 80-year-old patient sitting in my office chair, left to their own devices with a Q-tip underneath their eyelid. -- any number of things could happen.

Often, that leads to corneal abrasions which if any of you have ever had one, you'll know that it is 1 of the most uncomfortable things that you could ever have because of the density of nerves on the surface of the eye. And so while you can get a pretty good anesthesia by delivering that lidocaine exactly where you need it, unfortunately, there's definitely some downsides. As a result, I'd say more commonly these days, surgeons have moved to using subconjunctival lidocaine and this provides complete anesthesia. I mean patients typically don't feel anything at all when you use this. And that may have you thinking, well, great, why didn't everybody just do that. There's definitely some drawbacks, okay?

The primary one for me, and again, I'm going back to quality of life, is that when you place subconjunctival lidocaine, almost assuredly this patient is going to have a hemorrhage in the white part of their eye, okay? And so that leaves their eye, looking red, not being the greatest with cosmesis and you say what does it matter? They have a little red eye. That can last 3 to 7 days, sometimes even longer if it's a big one. When you're talking about these treatments, this is not like a flu shot situation where you get 1 and you're done for the rest of the year. You're getting a treatment potentially every month, potentially an injection in each eye every month. And that's a lot of people at the grocery store asking you, why is your eye red? I mean, that gets to be really tiring for these patients to answer.

Beyond that, yes, they may not feel the injection after subconjunctival lidocaine. The issue, however, in my experience is that patients are far more sore after the numbing wears off when using that method, okay? Last on here, I have high viscosity gels. And so what I mean by that are different sort of eye drops. There's thicker, the products out in the market are [indiscernible] that are not marketed for the eye. They're great, and they can achieve pretty good anesthesia. However, the high viscosity makes it really hard to get it out of the eye. Additionally, as a result of that, that Lidocaine just sits on the surface of the eye, and it can actually cause really, really large corneal abrasions and patients are absolutely miserable when that happens, leading to just days and days of discomfort that could have otherwise been avoided.

So what is IHEEZO, okay? And where does it fit in? It's special because it's individually packed sterile single-use file of chloroprocane in a low viscosity gel formulation containing hydroxyethylcellulose. That provides ocular surface lubrication in addition to the anesthesia provided by that chloroprocane intended for our procedure. So when evaluating a new product for me on a day-to-day basis, there's kind of 2 questions that come first: One is, does it work; and two, is it safe? The answer to the first is here. And basically, what they did was in a small trial, they tested for pain control. And the way they did this was they compared placebo which, as we saw earlier today, can be pretty powerful to the IHEEZO.

And what they did is they instilled one drop, one or the other, and then they use forceps to actually pinch the conductive to see how the patient responded, whether they were uncomfortable or not. And as you can imagine, your eyes really, really sensitive. You're going to know if your eye is not numb and they found that IHEEZO worked 90% to 95% of the time, depending on the type of installation. Okay. Here, you were going to answer the second question on is it safe, okay? Now with intravitreal injections, the most dreaded complication is an infection.

The Most important tenant in medicine is do no harm, and you don't want to use any sort of product that is going to increase your chances of causing a patient a problem, okay? And so what they did is that basically, whenever we do intravitreal injections, we always have to anesthetize the eye, we always have to clean the eye, okay? Cleaning the eye is very, very important. And so we needed to know Will the cleaning product, in this case, Betadine is typically the gold standard in our industry. Will it penetrate this product and make it to the surface of the eye to kill the germs that we need to kill. And the answer here is that, yes, absolutely, Betadine does penetrate this product because it is a special lower viscosity. It's able to make it through and kill a germs and actually may even have a biteriocytol effect of its own, though, obviously, a larger study would need to be done.

So I started using IHEEZO about a year ago. And I'll say that for me, it's delivered my patients exactly what I need. I find that I get a significant amount of anesthesia quite quickly. I've actually had a decrease in infection rate over the last year that I'm in the process of publishing. And my patients have been exceedingly happy with their experience. Many even a year later even though they've seen me 5 or 6 times since I made the switch are still thanking me for having switched them to an Igel that works really, really well. One of the most significant wins here, though, is not just how well it achieves anesthesia for the procedure itself because I think naturally, you think, oh, perfect, you need to have the most numbing possible, that's all that matters.

And actually, it isn't. What really has been the biggest gain for my patients is that due to that low viscosity of the IHEEZO gel, it doesn't stay in the eye forever. It doesn't cause really painful corneal abrasions . It rinses itself out with the tear film or if you physically rince them afterwards quite easily and the hydroxyethylcellulose works as an ocular surface lubricant, which allows for quicker recovery from the irritation after injections. When you think about the burden of a single injection on a patient, as I mentioned before, it may not seem like much. You go for a flu shot, it takes a second, and you're out of there.

But again, you think about that patient that may need monthly injections possibly in each eye talking about 24 injections a year. Prior to changing to IHEEZO, often my patients will report, they need a day or 2 for their eye to feel the same again and to go back to their normal activity. Now most of my patients feel back to themselves within hours, and that quicker recovery gives that monthly bilateral injection patient back 3 to 6 weeks of their life in a given year. and I cannot think of something more valuable than that. Many of them, I get e-mails, text the same day, my patients that know me, and they're out to dinner with their wives, they're watching sports games at night.

They're having an amazing time in spite of the fact that they have a sight threatening condition. And that's what I mean when I'm talking about quality of life and how much of an advantage it brings.

Now it's all well and good to have really amazing medication. But in the real world, you have to be able to get that medication for your patients. And I think this is kind of the third question I always ask is, well, can I get it? Who can get it. And thankfully, it's pretty well covered. Going through this process of getting this medication into my clinics, thanks to the Harrow team was really, really seamless. We have really good coverage for patients, 90% of covered lives, very few patients require prior authorizations. The medication has its own established or permanent J-Code. So it can be used in the office setting and my billers know what to do with it. It's very easy for them to put that through. You can, in addition to the injection setting, use it in the ambulatory surgery suites for cataract anesthesia. And again, because Harrow makes it their mission to help everyone, I don't have to say, okay, you have good insurance. You get the good numbing. Oh, you're a charity care patient, you don't get the good stuff. I get to use it for everybody without second thought.

And as a physician, ethically, I could never sign on to using a product where I can't use it for everybody. It just doesn't work for me. The point is to help everyone not to treat anybody differently because of where they come from, what their insurance card and their wallet says, and again, quality of life matters. I want everybody to walk out of my clinic receiving the same excellent quality of care. So I hope that helps you gain a better understanding of the value that I think IHEEZO brings to my day-to-day clinic. And I'll turn it over to somebody very special to me. Ali touched on Dr. Seenu Hariprasad. He's the current Chair of the Department of Ophthalmology at University of Chicago. And 10 years ago, he trained me to what I do today. And I'm very thankful to him for everything he's shown me and really appreciative to have him here joining me this morning.

I'll tell you, it's such a privilege to be here with you all today. in my lifetime, I'll be able to see 185,000 patients in my lifetime. But the reason we're in education, I've dedicated my career 20 years at the Jersey Chicago. And I'm on my 22nd retina fellow. Raj was my 11th retina fellow, this young army that I'm training. I promised a minimum of 25 fellows in my career. And this group of young, very ambitious retina specialist I'm training can see about 3.2 million patients in their lifetime, which means more IHEEZO, TRIESENCE and so on and so forth. So -- but it's very special here. I've gotten a lot of thank yous to make the trip from Chicago to come here. But I was telling Mark last night that thank you goes to all of you in the room.

The days of us making products in the bottom of the university basement and coming out with some innovation, those days are over. That's not how innovation happens in our field. It's this triangle between physicians, the investment world and pharmaceutical world, okay? And this was readily apparent about 15 years ago when the whole design of drugs changed in our field, probably about 2 decades ago when it first started.

And so the thanks goes to all of you for spending the day here, and I think this is the quickest what it was 4 hours so far that have gone by. And so we really appreciate this opportunity to be with you today. Now just a few words about Harrow in my 2 decades of practice. I have never met a company, a CEO that take the time to come to our meetings and meet with us individually and understand our unmet needs at the ASRS meeting, American Society of Retina Specialists Meeting in Stockholm. Mark was at the meeting. He met with myself and other respected colleagues to understand our unmet needs what we need in the field, the importance of a proper supply chain, what was needed for us to take good care of our patients.

No other company does that a CEO of a company walking around the hallways of the meeting, meeting with us. and that means a lot to us, okay? And [indiscernible] also mentioned that the supply chain, the consistency of the supply chain is so important, you take TRIESENCE, for instance, it was a 5-year period. We used to use it like water, and there was a disruption of the supply chain. And now ketorolac, there's a disruption in getting ketorolac vials. And this is very difficult to manage in our practices, but also a company which understands our unmet needs, the changing fiscal environment from federal policies, and I'm going to talk about this later in this portion of the lecture series and understanding what our patients' needs, these are all very important. So this slide is a very important slide showing the prevalence of disease in our practices.

It's not showing the number of patients we're seeing but it's showing sort of the breakdown of the diseases we're seeing in our practice. About 1/4 of our patients are macular degeneration as seen in the first 2 bars and about 1 in 5 patients have retinal vein occlusion and diabetic eye disease. But what this does not show is the number of patients we're seeing. When I started in 2005, I saw about 2,400 patients a year. Last year, I saw 6,500 patients, okay?

So the population is getting older. And it's a snowball effect. Every patient that needs a biosimilar, every patient that needs an injection in the eye, that's a repeated number of visits throughout the year. So the snowball effect is very important to comprehend. I don't think the proportions will change too much, but the numbers of patients we're going to see are going to increase dramatically. So undoubtedly, age-related macular degeneration is the leading cause of vision impairment and blindness in our country and perhaps the world. 196 million patients globally, but by 2040, 288 million patients. But there's no doubt that cost is a serious barrier to optimal anti-VEGF treatment and it is getting worse and worse. Every week, denials and all sorts of issues and now sort of tiered policies of what treatments we can use first.

And it's all about cost cutting, expense cutting and it's very important that we have various options to treat our patients. Now this is a very important slide that shows that biologics account for greater than 40% of U.S. prescriptions as you can see on the left side of the pie charts. But on the right side, you see that it only accounts for 2% of a prescription drug use.

Okay. So just to try to understand what this is saying that the small sliver is such a huge expense for Medicare and rest of the payers. But once again, this expense to society, the access to our patients, this is very problematic and getting to be worse and worse on a weekly basis with changing a federal policy. Now the biosimilars, why are they important to us? They improve access to care. There are many payers. This is the first line, and the patients fail this, then we may try other options. It increases the number of options we have for our patients, but once again to lower cost. As of September of this year, 77 biosimilars have been approved. So this is something that's really becoming a well-established approach to patients in multiple disease states.

So BYOOVIZ a biosimilar referencing Lucentis and it's FDA approved for the treatment of neovascular wet AMD, macular degeneration of the wet type and macular edema following retinal vein occlusion and myopic choroidal neovascularization. This is a serious problem overseas perhaps upwards of 20% of patients with subretinal neovascularization overseas is due to myopic CNV -- very simple registration trial. This is the layout of the study, patients were randomized 1:1 Lucentis versus BYOOVIZ, the biosimilar Lucentis as a reference product and the assessments you would expect in these type of studies looking at visual acuity and drying central retinal thickness on the OCT. So focusing on the left side of these slides, Blue is BYOOVIZ and Black is Lucentis.

If you look at the time course of vision change over the course of 1 year, they're essentially superimposable. You cannot tell the difference between the biosimilar and the reference product, Lucentis. And likewise, when looking at anatomical data based on OCT, the macular thickness. The blue and the black lines essentially are indistinguishable. So there's no doubt that the Phase III data supports the biosimilarity of Lucentis and BYOOVIZ. Now the first biosimilar was approved in 2015. But as I indicated earlier, in September of 2025, 77 biosimilars across all different therapeutic areas, oncology, rheumatology, endocrinology but only recently in ophthalmology. We're just starting in ophthalmology. But look at the cost savings, and this will only increase exponentially.

The health care system saved $20 billion in 2024. And since 2015, $56 billion. okay? So just think about the savings to the health care system, which, as you know, is really suffering and trying to cut cost. So biosimilars are very well poised to changes that I predict we will see in the health care system. So if you look at this, I mean, look at the increase from 2015 to 2024, a huge increase in the uptake of biosimilars. And as new therapeutic areas start to adopt biosimilars, this number is only going to increase. But once again, very important that every retina specialist, even a small sliver of their practice could lead to billions in savings, billions. It's very important.

Now when I talk about federal policy, once again, Harrow, of all companies really understands what's going on. We are being squeezed in retina. I know it's hard to believe the way retina specialists do we do well. And -- the issue is that the margins are squeezed, all right? Back in 2005, maybe we had $475 per needle we stuck in the eye. Now we're down $104, okay? The margins are shrinking and shrinking -- so how does government see this in terms of the adoption of biosimilars. There's something called the ASP and the Affordable Care Act. We don't want to penalize a physician for choosing a less expensive drug. So the ASP can range from 6% to 8% of the drug price. So think of it as a profitability to a retina practice. So if you have a $2,000 drug, the profitability is $160 on just the drug alone.

So if you choose a drug that's half the price, instead of making $80, you still get the $160 of the reference product. So as to not penalize the physician for choosing a more sensible cost-effective option. So retina specialists are trying to understand this payers are demanding that we use biosimilars first line and it's going to get more and more. But this is a very important slide to understand that there is a strong incentive to at least consider biosimilars. So of course, we want to use what's best for the patient. But I think that over time, practices are going to understand that there is a very important reason to at least consider the use of biosimilars. So biosimilars, in my opinion, are a smart choice and should be considered.

The biologics are very specialized therapies that may be very costly to the health care system. They are cost-effective alternatives, the biosimilars that can also improve patient access. I practice in the south side of Chicago, and patient access is a serious problem, you have to have biosimilars in your fridge and this is not off-label Avastin, okay? This is FDA label drug. So there's a very serious and very important difference between the 2. And so the biosimilars are rigorously tested to ensure high similarity with no clinically meaningful difference to the reference product, once again, FDA labeled. So I think retina specialists really should be committed to expanding patient access to these life-changing biologic medicines.

The other thing I want to say about biologics, and biosimilars is that there is tremendous excitement about OPUVIS. [indiscernible] and we expect to get this very soon into our offices. And I think that this will really increase uptake in terms of the use of biosimilars in retina practices. I want to switch gears and talk about intraocular steroids. We use all sorts of steroids to treat inflammatory conditions, diabetic eye disease, macular edema following retinal vein occlusion in our practices. They're all different, typically triamcinolone, dexamethasone, fluocinolone. And they all have different durability based on the way they're delivered to the eye and most of these are intravitreal subtenants.

And I want to focus on the top 2, TRIESENCE, the Harrow product, an off-label [indiscernible]. TRIESENCE is not just a branded version of off-label catalog. It is a manufactured and very carefully developed product, that I was personally involved in, when Alcon got into this back in 2007, myself and 3 other retina specialists, we went to Alcon, and we really made a case of why we needed an on-label version of this drug. As you all know, that catalog, if you look at the bottle label on your Google images, it says not for intraocular use. It clearly says it in big bold phase black letters -- and that really was the straw that broke the camel's back that we needed an on-label version to inject into patients' eyes.

So TRIESENCE is an on-label version -- and then we saw this issue of inflammation in the eye. It's called pseudo endophthomitis. Endopthemitis is a dreaded infection in the eye when you inject anything in the eye, you stick a needle in the eye. But these eyes look quiet, there's a hypopyon, this layering of a white material in the front of the eye. It's oftentimes very hard to distinguish from infection in the eye. And what we later found it was the preservative and catalog that was causing it. So that was the second reason that we needed this formulated version that was preservative-free that did not have the preservative in the vials. And then the other thing is Raj and my other 22 retina fellows, we train them to highlight the structures in the back of the eye during vitrectomy surgery and the very fine mill size of TRIESENCE is very important and very different than the crystallin properties of catalog we highlight the structures very well when we use it during vitrectomy surgery. So this is the labeling for TRIESENCE.

Once again, it's very similar to the catalog labeling, but it is approved for various inflammatory conditions in the eye but also visualization during vitrectomy surgery. A lot of research has been done at David Dyer's group in Kansas City and others, showing how it can make a huge difference in terms of seeing what we need to see during vetrectomy surgery. And personally, from a training perspective, it really helps my residents and fellows see what they need to see when they learn vitrectomy surgery. And it comes -- the label gives us a lot of flexibility in terms of how we dilute the drug. In the office, we may use 40 milligrams. We may use 4 milligrams, 40 is [indiscernible]. 4 milligrams is intravitreal.

But in the operating room setting during vitrectomy, we have all sorts of dilutions based on the structures we're trying to highlight. So to conclude, TRIESENCE is not just regular catalog or regular triamcinolone. I indicated it's preservative free, and this is a very important property of TRIESENCE, to help prevent this pseudo and optimitis that was seen with catalog and caused a lot of problems. The particle size distribution, the mill size of the product, it's almost like a powder when you use it. So it mixes when you apply it in the back of the eye, it's a very consistent coding of the retinal structures. Unlike catalog where you have the snowball effect, especially when you inject it in the office. It is FDA approved.

Steroids do cause pressure elevation. They cause cataracts. And if there's a problem, you better believe Rod and I, we want a labeled product. If that escalates to a problem in the court room, I think it looks a lot better than having a drug that says not for intraocular use, okay? And lastly, the expanded reimbursement access. This is a very important thing to understand. And this is the nuts and bolts of what we do on a day-to-day basis. the payer access is very important to understand, and I'm sure at a later discussion, we can talk about this later. So with that, I'm going to conclude, and I look forward to any questions during the question-and-answer session.

And I want to introduce John [indiscernible], just has been such a great partner in ophthalmology and retina over the decades, and he is the Chief Executive Offer of ImprimisRx. So thank you very much for your attention.

good afternoon, everyone. Thanks for the presentations today. They've been amazing. I know many of you have followed us for many years, and I have been in health care 35 years now, the last 12 with Harrow/Imprimis. I had the good fortune of meeting Mark and Andrew in November of 2013. Shortly after that time, the Drug Quality and Security Act was signed and Imprimis became real, right? Back in 2013, we had 0 products, 0 customers, 0 revenue. We started our venture in 2014, with a small pharmacy just over the river in Randolph, New Jersey and begin to serve some states up here in the Northeast. Actually, our 2 salespeople were based out of the California office, and they had to travel quite a bit to get us started.

But fast forward to today, and we generate over $80 million in revenue. We generate a very healthy EBITDA and a very healthy cash flow. So it's been a amazing journey. Today, we have 40 products. Back in the day, we had 10 people. Today, we have about 170 in the Imprimis business. To date, we have served over 65 million eyes, very proud of that number. All of that product was built in the facilities that are in New Jersey and mainly obviously U.S.-based. Today, we have about 15,000 customers that we serve in the U.S., and that is a mix of both ophthalmologists and optometrists. Our product portfolio of 40 products roughly has come from that group, right? All of the products that were built and made and developed were from either an optometrist or an ophthalmologist that had an unmet need. So it's been a labor passion. I love the business that we're in.

We have really it's broken down into 3 categories. We have a perioperative category. We have a chronic category, and we have an acute category, the smallest of the portfolios, but the acute is actually a very important product is fortified antibiotic used for serious eye infections. Doctors call it the Friday afternoon drug because hard to find a compound therapeutic kind of Friday afternoon. But the perioperative is really the biggest part of the portfolio, drugs used prior to surgery. You've seen how many surgeries are performed ocular surgeries in the U.S. We have the products that are used during surgery. And then typically, postoperatively, you're dealing with a steroid and antibiotic and an NSAID. So that's really what is the base of our overall portfolio.

Our business since we started, and again, since I had the opportunity to meet Mark and Andrew is the land and expand strategy, right? We have a really broad portfolio. We might enter an office with a mydriatic. We might enter an office with a product that's used to dilate the eye. So there's just many, many options for us to have that first conversation and that first entry into the practice. From there, we've had a great history of and retaining our customers over the years. We did a 5-year projection last year when we were building out our 5-year plan for imprimis and we looked at the customers that were joining us along the way, starting back in 2014. They stay with us. It's a great model that we've built. We solve a lot of unmet needs and help build out that portfolio.

What we built it around high quality, accessibility and affordability. And that really transfers over to the Harrow portfolio overall, but that's what we started with at Imprimis. More recently, we had our first example of Project [indiscernible]. Project [indiscernible] was where did we have a branded alternative that could better serve that customer. So just recently, since -- we started it back in February. We took the Clarity C, which was a wonderful, great product that Dr. Lindstrom actually brought to us. And it made sense that Dev would be a good alternative to the VEVYE portfolio. So we executed against Project Beagle. All those [indiscernible] patients are now happy with their VEVYE drug that's appropriately reimbursed. We also had another product in the portfolio called. [indiscernible] It was a preservative free tier, and those patients have now been converted to FRESHKOTE. So that will go on as we migrate over time, we've got a great opportunity now with the MKO Melt and what's coming with Melt-300. So that will be the next -- one of the next project Beagle initiatives. So with that, I would like to bring back our CEO and Chairman, Mark Baum, for closing comments.

I didn't know I had to come back up here, but Nevertheless, let me just thank all of the physicians, the leaders of our business. I have 2 board members here, Adrian Graves and Perry there's Perry. And I really want to pay special attention to Dr. Dick Lindstrom, who is in the center of the room. When we were getting the business started, I'm new to ophthalmology. I didn't really know anything about ophthalmology when we started this business. But Dr. Lindstrom is a legendary force in not only the U.S. market, but around the world. And kind of took me and this company under his wing, and really helped us build this business. This business wouldn't exist without him, frankly.

So thank you, Dave. I guess we're going to get to the fun now, the Q&A. Let's jump into that, Mike. And once again, before we begin that, let me please once again, thank you all for being here. It's hard for us to believe, Andrew, that we've been able to build what you've seen over the last dozen years with all of these incredible partners. It's just unbelievable starting with $1 million. I guess in poker, they say, if you have a chip and a chair, you can win the tournament. That's really what we feel like we've done, but we're just getting started. So let's get it going. Thank you.

All right. We have more time for Q&A. If you want to ask a question, just raise your hand and I'll bring you the mic.

[indiscernible], maybe just Dr. Hariprasad and Dr. Patel. Can you maybe just speak to what percentage of your patients who are getting intravitreal injections get biosimilars today? And then what makes that decision as far as what biosimilar you use?

So once again, you remember from my presentation, we talked about a supply problem with a lot of the drugs we use. Catalog TRIESENCE was a big problem for almost 5 years. And BYOOVIZ, actually, we had disruption for almost 2 years that we had problems getting the drug in our hands. And in the university setting, getting it on formulary and then being able to actually build for it through our EMR systems, that's a process that takes place. So we finally have it back on board and all that, but there was a big disruption for about 2 years. But in the hay day, when we partnered with Biogen to use BYOOVIZ, it was easily about 5% of the patients that we do injections. So it's not insignificant, but the landscape is very different today than about 2 years ago, where payers understand that these are FDA-approved products.

It's very hard for a pair to insist on the use of Avastin and off-label therapy to treat our patients but an anti-VEGF that has a label for these various diseases, that's a different story.

Yes. I would piggyback off that and say it's about 5% of my practice. I think that number has been rising, definitely in large part due to the payers. And also from us, because as surgeons, we don't like, as he's talked about multiple times, we do not like non-FDA labeled medications. The less I use compounded Avastin, the better and so we actually have been actively lobbying against the insurance companies to say, when we talk about step therapies, you may know, the insurance companies say, okay, you have to use 3 of Avastin, have a follow-up, then document that they didn't do as well as they needed to, then they graduate you to some other medication, and they're kind of calling all the shots. What we're trying to do in return is say, how can you make us use a non-FDA labeled treatment for this patient at all.

And so we're trying to get the use of these biosimilars going because that's a perfect first stop for a patient. It's labeled for them. It's economical. It's safe because it's coming from an actual pharmaceutical company instead of some Joe Schmo Pharmaceutical like compounding pharmacy in the middle of Alabama. If you've followed the news, there's been outbreaks of endophthalmitis because of some of these really shot run compounding pharmacies. And so we don't want to ever see that. And it's a big problem, and I think this is a really good solution to that problem.

I'm so glad Raj brought up that topic about sort of the pathway of how these drugs get into our hands. Avastin is compounded. We take a big vial of Avastin, the oncology vials. And 1 large vial goes into about 14 to 18 Avastin syringes versus BYOOVIZ, 1 vial, 1 patient. That's it. So if there's a horrible event, some sort of endophthalmitis or some sort of infection in the VEVYE, one patient goes blind versus 18 patients. So it's more than just the FDA labeling the difference between Avastin and biosimilars, but rather, there's actually a very practical reason. One VEVYE patient is strongly preferred.

And then Mark, maybe can you speak to how you guys expect to do biosimilars is a little different. And then the first launch with BYOOVIZ, the first time similarly had a fairly dominant market position. How do you change that this time when you relaunch under your brand?

Yes. I think -- and Ali talked a lot about this. First of all, [indiscernible] mentioned the quality of the team. I don't know that there's a team quite like the 1 that we have and that we've been able to assemble. So we're not going to play just on price. And we're going to talk more about this, I think, Andrew, as we get further into next year in terms of how we maintain not only the service levels to the customers, which is part of the plan, but more importantly, that we have a durable presence within the market. And we don't see sort of a death spiral on pricing, which is what you've seen with other biosimilars in the market. So we're going to talk more about that as we get closer to the launch. But the key for us, and I touched on this, I think several of us touched on this, is we don't get into a market so that we can participate for 12 months, 18 months or even 2 years.

I've said, for example, we're going to sell more TRIESENCE hopefully in 2035 than we do in 2025. And we will participate in the biosimilars market for many, many years to come. We also think that anti-VEGF therapy will dominate the market for a long, long time. And I would always refer to the docs on that, but we see those as the strongest products to treat this disease for maybe the next decade or so.

[indiscernible]. Just to follow up on that question though, particularly in the BYOOVIZ market, what accounts for the penetration of compounded Avastin rather than moving to [indiscernible] was startling how big that column was in [indiscernible] slides.

It's just for access. It's all about patient access. And it's highly problematic. And even with a biosimilar, it's less expensive, but it's not $31. So we really need Harrow to partner with our practices to have patient access programs which I can personally say are very strong and similar to many of the large pharmaceutical companies like Regeneron, Genentech and the others. So these patient access programs are going to be very important for the biosimilars as well.

From my perspective, this is an ethical thing. I -- my father is here, actually. And if my father had this disease, would I want him to get repackaged Avastin.

I don't want him to bear those risks. Now he may be able to afford the good stuff, as Dr. T said. But everybody in our view, should be able to get the most efficacious and the safest therapy. And that's an FDA-approved product. And that's what we think about when we think about access solutions. So -- that's the way we've operated the business. That's the way we built the business. That's the way we've created relationships with doctors, and that's what we'll continue to do. I've found that if we make a little bit less on the front end, over a longer period of time, our relationships are so much stronger, and we create so much more equity and value for our stockholders, if we just do the right thing. Doing the right thing for these patients is ensuring that they have access to an FDA-approved on-label therapy at an affordable price.

And switching gears a little bit to Larry. So it's been a minute since we saw the MELT-300 data, but we're not looking for an NDA submission until the first half. Can you fill in that time line? It seems a little bit long.

So I'll chime in here, too. We've got some ancillary studies to run. There's 4 studies that need to be run [indiscernible] studies or labeling studies. We're going to get those kicked off here very shortly and should have that data in the final study reports in 3Q of next year. And then we'll -- in parallel, we'll be assimilating the NDA. And I think 26% is still doable. [indiscernible] is still very doable. But I'll let him your Yes, yes. Hello. Yes. So obviously, we're going to try to beat the time line. Anything we put out, we either beat it or meet it. So that said, Larry pretty much walked you through what needs to be done. But there are numerous activities that need to be put in place. So if we were to tell you, December 31 of 26 I don't think it would make a difference. So we are confident with the '27 [indiscernible]

So [indiscernible] from B. Riley Securities. Maybe a financial question. I saw the 2027 quarterly revenue goal stayed the same. -- couldn't help notice the line item under retina disease portfolio going from, I think, $20 million, $25 million to I think you're talking about $140 million by the end of 2027. So if you could maybe talk about what the different components of that business line item is. And it looks from your biosimilar time line that, that doesn't come live until second half of 2027. So it looks like a lot of growth in IHEEZO and TRIESENCE. So maybe talk a little bit about that.

Aly, do you want to come up here? So [indiscernible] , thanks for coming, by the way. Good seeing you. There's -- so importantly, on the retina side, we do have 2 new products coming to market in 2026 and hopefully in 2027 with BYOOVIZ and OPUVIZ, respectively. Those are massive markets, massive opportunities. We're seeing with that first Eylea Biosimilar right now, the opportunity within that market. And I think it's only going to get better for these Biosimilars over the next 2 years as we prep for that launch.

And we're going to have time to prep. I always tell people, when we do deals, a lot of times, we're buying the product, it might be post approval, and we're kind of building the plane while we're going. VEVYE is a great example where we acquired the product and we launched it like 2 months later. And we had to kind of figure out the launch plan along the way. OPUVIZ, we're going right into an existing market that is massive. I think $8 billion, $9 billion -- and we've got time to kind of plan it out. We've got the relationships already in place with IHEEZO. And we get kind of like a test case with BYOOVIZ, which is a great product as well.

And so everything is going to lead up for that product to be really, really successful, and I think it's going to have an immediate impact. BYOOVIZ is also going to have a really big impact. I think it's going to be a pretty quick uptick as well. I'm putting a lot of pressure on Aly right now, but she can take it, trust me. And then IHEEZO is rolling. It's going to be a rising tide for that product as well. It's already picking -- getting more uptake within retina. Aly and her team are doing a great job building awareness for the product. And you'll see that product come up as well from a volume perspective. I'd love to put out a bigger number, but Aly has already got enough weight on her that. But I definitely think she can do even better than what we have.

And then on the Harrow Access for All, it seems like an extension from VEVYE Access for All and it looks like the big focus is on the surgical specialty products. You also had IHEEZO Access for All launched recently. So maybe just talk a little bit about your learnings from both VEVYE Access for All and IHEEZO Access for All and how you think about that evolution going from a patient who is on a $59 script to maybe getting them on a commercial insurance script.

I think the whole -- all these Access for All programs are centered around what I tried to talk about. And that is over the last dozen years, I love going into physicians' offices. I sometimes will get there before the salespeople get there because I want to talk to the staff or even sometimes talk to patients.

And when you meet the people that these doctors are treating, you really need to -- if you're smart, I think, as an executive, help the doctor take care of all of their patients, the rich, the poor, the ones with good insurance, bad insurance or no insurance, make sure they get access to these medications. We have such a broad portfolio at this point.

Frankly, I think it's incumbent upon us to make sure that these products are available. [indiscernible] , for example, is the only FDA-approved antifungal. The drug that John and his team make for these sight-threatening infections is refrigeration stable and it's in physicians' offices to make sure that these patients can get taken care of. And so what we're trying to do big picture, Mike, is partner with the doctors and really build, and I hate the word ecosystem, but really a platform that they know they can reliably access that we partner with them to make sure that if their patient has a need, they will get affordable access to that medication.

What you will see with HAFA, the broad program that I've worked with, with Prashanth, who's my partner here on a lot of the stuff is a series of decision trees so that a physician, it's a cataract surgeon, can come up with a protocol for that patient or a LASIK protocol or a retina protocol or a you name it protocol and that we can take them through a series of medication choices for those patients that they approve in a seamless, efficient way and ensure that they get -- the patient gets access to the most appropriate medicine, consistent with what the doctor's office wants. So it's a series of digital decision trees that will be made available in the second phase of the program. Does that make sense? Thank you, Mike.

Steven Seedhouse with Cantor, and thanks for hosting the event. It's great to be here. It's a great event. I wanted to ask maybe first on MELT just with respect to the label expansion strategy and any clinical studies that would be required, timing of those, the scope of those and just what to look forward to even between now and approval and subsequent to approval.

Yes. I mean I have a perspective also, I'm not sure...

So in respect to the label expansion, we'll have to go back to meet with the FDA. And I would think of the pain, the Lortab's kind of the world. When they go to do get their label, they don't run studies in every single pain state that you can be in. They find 3 representative studies, [indiscernible] of abdominoplasty and bunionectomy. We'll have to get agreement with the FDA in some sort of analogous way on sedation. So we'll have to -- we've already done cataracts. So we'll go back to the FDA, talk to them what other representative procedures would they would kind of make them satisfied with giving us a broad sedation label.

So the product will get filed, this call it, let's call it, early '27. As soon as it gets filed, we -- I believe we should meet with the FDA, get that nailed down and begin the work and then do that work while MELT-300 is existing on pass-through for cataracts. And that's plenty of time.

I mean the short answer is it's up to the FDA.

The short answer is there will be other studies, so there will be more.

But the good news here, too, is because during -- and I mentioned this in my talk, but what we did is we met the combination rule for every combination product, you've got to meet the combination rule. Future studies now are just going to be against placebo. There's not going to -- there won't be an active comparator. That's a big deal.

And you can do placebo-controlled studies for the indications that...

Right. There's rescue involved, right? So they're not -- the patients aren't going to be at risk or anything, but the next studies will be active MELT-300 versus placebo because we met the combination rule...

I was just going to add, one of the other things we didn't mention in the press release or even in the 8-K is that MELT really is more than MELT-300. There's actually a MELT-210 program that was a part of this Louise study, which is midazolam only. And so there's a significant body of data against midazolam in the form of the Zydis technology versus placebo. And so that's -- we have powerful data there as well. And so it may be the case that we have more than one product in that we can talk to the FDA about.

The other thing to note is that in anesthesia, it's a little different than ophthalmology. We're happy to use things off label. Standard of care for our type of field is what a reasonable practitioner would do in your shoes. That's not really a hard bar to beat if you're talking about procedural sedation. So once I envision it hitting the market for cataract surgery and you have it now in our tool belt in the anesthesia realm, you'll start using it for other things, whether or not the label is there yet because our standard of care is kind of set differently. It's already a safe drug. It's a sedation drug.

And anesthesia depends a lot more on the experience of the practitioner using it. So I envision most people, once they kind of see it, use it, they'll start doing exactly like I do every day with the compounded version is, well, can I use it for this patient? And what about this patient and start kind of pushing the envelope. I get a lot of calls already from office surgeons asking about its safety profile. That's probably my #1 common question because it's surgeons having to administer it traditionally in the office. And personally, I think one of the greatest things about it is its safety profile because right now, when I go into offices and I hear what kind of -- I'll use dentistry, for an example, and they're giving a narcotic, they're giving a Percocet. They're giving like a phenergan, which is an anti-nausea medicine that also is a potent sedative combined and then sometimes a volume with it.

And I think, oh, the horror, like we're lucky, more patients aren't dying in offices because those are really dangerous combinations. And I mean, we found and they continue to study that the safety profile is extremely forgiving when you leave out the use of a narcotic.

Can I just follow up on that and what you commented on in your presentation, just the different use cases. And it's related also to the fact that I think there was mention in the deck of $500 per unit drug price that would be relevant for the reimbursement. How many units are -- like what is the average number of units that you would need for cataract versus the other procedures that you're familiar with, with MKO Melt?

It's an excellent question. So the compounded version of the Melt-300 are slightly different. Most of us who had used the compound thought we should increase the ketamine component of it. So I'm really excited to be able to use MELT-300 in my practice. I think this version and in the studies, they used 1. I think we'll be going down to 1 from the standard 2 of the compounded version that I'm currently using, which has a lower dose of ketamine.

So I think we'll have to use less. It's also somewhat, again, anesthesia sedation is a little bit of an art. You also have to get used to using the drug. So as people start, they'll either overdose, underdose, and I don't mean overdose doesn't harm the patient, give more than they need or give too little, and you'll find that sweet spot. And I do think that they hit it perfectly with the one being all most patients need.

Great. And then maybe just for Mark or Andrew, if you wanted to take the opportunity, I want to ask just on the VEVYE volume, net price refill rate reimbursement in the third quarter quarter-to-date, if you have any comments on how the quarter has been?

I'm the wrong guy to ask. I'm always telling Mark, we're putting out too much script information because all of our competitors see that data. I can just say what we are seeing with refill rates and the continuation of product demand for the product is very, very strong in Q3.

I wanted to add one thing, go back to the prior question because I think it's interesting on MELT and we were excited about Larry on the Phase III data. The 3 milligrams of midazolam on the PK side of things converted to what equivalent in IV, about 1.75 ccs. And so if you think about 1.75 milligrams, is that enough to...

Yes. The typical dose of IV midazolam that's used is 2 milligrams. So it was extremely close. So I think the difference between 1.75 and 2 is an insignificant clinical difference. And also to comment on the price per unit, a lot of these office-based procedures are out of pocket. These are patients that are paying $30,000 plus for dental restoration and cosmetic procedures and all of that and adding 500 for their comfort, I usually find patients not even flinch in the substantive area when you're talking about some of the office-based cash business.

We'll have to see also how we price it. I mean there's an ophthalmic opportunity with pass-through and then there's a much bigger opportunity, not only in ophthalmic surgery, but in these other use cases. And so we'll have to see ultimately how the product is priced.

Lachlan Hanbury-Brown, William Blair. I guess first question was, Dr. Patel, you were talking about IHEEZO and you want to be able to give everyone the good stuff. Do you give everyone IHEEZO? Are there patients that you don't give it to? And if so, why? Are there clinical situations that you wouldn't do it? Or are there still some access barriers?

No, I appreciate the question, actually. And I was going to piggyback off of what Mark was kind of saying to the previous question about Harrow Access for All. Aly and her team have made it seamless for me to provide it for everybody. I don't have to give second thought to anybody's insurance, and I don't make it a habit of ever checking. I just look at the retina in front of me and the patient as a whole and then we make a decision on what the best treatment plan is.

Harrow has been excellent at just taking that out of the equation. I always tell people whenever I was training residents going into retina is a fast switch sport because you're seeing 50 to 90 patients in a day and you're making decisions really -- you have to do it at an efficient pace. And when it comes to a numbing agent, you don't want to have to do different things for different people. That's, one, it's not fair, but two, it's also unsafe. When you start to do different things across the board, something is going to get missed, something is going to be done wrong.

Here, I didn't have to ever do that. I -- actually, when I talked to my sales rep initially, she said, "Yes, you can make it your standard of care." And I said, well, what do you mean? That does not compute. Like as a doctor, that never ends up being the answer. There's always an insurance problem. There's always somebody telling me, no, I can't use what I want for that patient. But no, I use it on every single injection, whether they have platinum-plated insurance or they're seeing me and I'm doing pro bono care.

All I have to do is ask my rep, "Hey, I'm running low on my samples. Can I get more and I sign a form and they come." And so they make it really, really seamless to get it going. The biggest thing is just, I think for people that are used to doing things a certain way, it's hard for people to change, right? Like you get in the habit, 10 years of doing something, 20 years of doing something. Any one of these docs up here will tell you, you just -- you get into the rhythm of things, and it's hard to change.

Interestingly enough, I'm the second of 3 surgeons in our group. There was one that's 10-year senior to me, and then I recruited somebody a couple of years ago. The senior doc, if you remember in my slides, he was using topical drops and had been for decades. And the one that I recruited had been using subconjunctival lidocaine, his 2 years of practice. After 3 months of me doing what I was doing, they both changed, not from me telling them anything but purely because the staff who are administering the numbing agents, the staff who are answering the phone calls after patient care was done, were telling them, "Hey, Dr. Patel have any people calling us back after hours or later on in the afternoon because they're uncomfortable and they both switched." And I didn't say a word to either of them, and that does not happen often in medicine.

Yes. I guess for the company, I think a few of you mentioned that with VEVYE and [indiscernible], the addition of the second pharmacy partner should or is increasing coverage rates. Can you maybe just elaborate on that, give us a sense of how much of an impact you are seeing or expect to see with the addition of ApolloCare on top of Flarex?

Unfortunately, you sign up with these specialty pharmacies, you don't have complete visibility into their pharmacy network to determine what the overlap is. You can make an educated guess. But we don't completely know the entirety of the overlap. We do have a belief that we've significantly expanded the overall pharmacy network and the contracting that those pharmacies have with the plans. But this is a new relationship with ApolloCare.

So we need to collect some data. But I think Prashanth said it, we're sort of pharmacy agnostic. At the end of the day, if a pharmacy partner will submit to our business rules and our algorithm so that the patient gets treated appropriately and that the physician's office has a high-quality experience, we will bring them on to this program. And candidly, we're open to other competing products even joining our platform in the future. At the end of the day, the vision for Harrow Access is to really make sure that every physician can take care of their patients in an efficient way. And we do have a broad product platform. But if others are interested in being a part of it, we're open to discussing that, too.

I could tell you from my clinical experience, I probably write about 50 to 60 prescriptions in day either refills or first new prescriptions. It's very rare for the drug not to go through for that amount. I have a good team. They've been doing a lot. They know how to do PAs. They spend a lot of time, unfortunately, in that area, and then perhaps that skews it a little bit.

And then -- but the rare case that it does happen, that's where I'll use samples if that's the drug that is the most effective for them. So -- but overall, I feel like the success in my clinic with this approach -- and a number of companies have been wise enough to use these online pharmacies is far better than our experience in the past. And VEVYE's unique $59 seems to be vast, well over 95%. I feel like I could certainly verify that with my staff.

We are starting to see coverage improvement. So that I can tell you is that -- and it is a slow slog, right, Maria? It is tough. We have to be very patient, but we are starting to see coverage come in at rates that are attractive for our stockholders. It's unwise for us as executives to submit to the rates that a lot of these other companies have submitted to. They're literally losing money on every prescription, and that's not really sustainable. By the way, thank you for coming. Appreciate it.

Of course. If I can ask one more. When you introduced VAFA, we had the price reset, obviously, with a big growth in volume, -- how should we think about that kind of dynamic with VAFA across the broader portfolio? Should we expect some kind of reset at some point in the next few quarters as you maybe see a decline in price or an increase in volume?

I think everything that we've done so far with the program with HAFA is theoretical. We've done a lot of modeling, and we have a lot of internal data that suggests that this should dramatically increase volumes and ultimately, profits that we generate from this program and open up access, which is sort of the 3 key factors. But it's just theoretical. We need to, as we did with VAFA, put it into practice. And so we're going to do that beginning here in the next couple of months.

Okay. Tom Shrader from BTIG. Thank you for the remarkable event. I want to stay with Dr. Karpecki. When you treat for dry eye, do you overwhelmingly treat with the cyclosporine? Or are any of the alternate drugs squeezing the class? And I guess what I'm really asking is, should they add a non-cyclosporine?

That's a good question. So typically, again, my clinic is 100% referral. So the patients have already seen a good doctor. They've already been managed. This is kind of a last stop. So I tend to begin a lot with steroids, believe it or not, topically to begin for the first month for a couple of reasons. One, that if they respond to that, I will go to an immunomodulator, whether it be VEVYE, for example, could be even lifitegrast. It depends on what -- how they -- what they have coverage, what's available.

But from the cyclosporin class, VEVYE is a very easy choice, just the tolerability, how quickly it works, it's there. But I'll typically start with steroid because if they don't respond to the steroid, I'll go down a path of biologics, which would be amniotic membrane, serum tears, something that is very similar to the way immunology manages patients systemically, and it seems to work well in the dry eye space also. So that's a more typical approach with the patient population I see. But with the -- with my colleagues who I educate a lot, and it's one of my goals to keep elevating the dry eye across the professions is they won't see that level of patient at the beginning.

So they are going to begin with something that they have access to, that goes through, that's reasonable for the patient, but that is in that category of immunomodulators and steroids a little less at the beginning of their process. I do feel like, though, when I talk to even colleagues within my practice, their goal is to try and get the right drop into the patient, and they are moving faster away from an artificial tear. I mean, meaning they may keep the patients on artificial tears, but they understand they're not going to get the results they want without prescribing a prescription medication.

And that's a big trend that's starting to happen at the primary eye care level. And for their decision, it's what is comfortable. The case I showed you was -- I wouldn't say he's an average primary care physician, but he does a lot of everything, glaucoma and glasses and contacts, and I don't do any of that stuff. And he says that so over him, his first choice is VEVYE -- that's based on clinical experience, his results that he's seen, where it's at, that might be a good proxy for general practice. But it comes down to access, what's available, comes down to experience and it comes down to the response to the first drug.

And just to be fair all around, there are some Xiidra super responders. I can't pick them out right away, but when I put them on it, I can't move them even to something as great as VEVYE. So if they lose access, I've got to find other ways to kind of get them there. So there are unique approaches depending on the patient presentation. And mucin deficient, which is where I'm staining on the way of the eye patients respond slightly different. They like Flarex far better. than loteprednol. But maybe a patient that's in an evaporative state tends to like those lipophilic drugs like loteprednol or equally.

So it's getting nuanced to that level. But in general, yes, I think doctors like to use something that they know is safe, comfortable and quick and tolerable. And so that's why I think VEVYE will probably be used there. In my clinic, it will have to show success with steroids and then I'll move to a drug like that.

Okay. And if I can follow up with a very general one for Mark and Andrew. I thought it's telling after the deal, you only kept $10 million of dry powder. Do you think you're largely done adding products? Would you be highly opportunistic from now on? Or are there obvious holes where you think you're really looking? And a related question is how fertile is the Project Beagle pipeline? Are there obvious huge compounded drugs that are just ripe to be spun out? Or is that -- are the good ones out?

I think there's -- I think we -- when we look at the field, there are probably fewer targets today than there were 5 years ago for sure because we've acquired most of them. But there are really interesting products out there. We always say if we can buy $1 for a dime or even a few pennies, we'll do it. Our stockholders should expect that. There are a few things that we're looking at. There was one that we were far down the road with recently that we withdrew from.

So it's got to fit into one of those buckets, the surgical bucket. It's got to make Chad's team more powerful. It's got to make Aly's team more potent, more important to the customers that they serve. Same thing with Maria. But there are a few things that we're involved in. As you've seen, we like structured deals. We don't like to pay full price. Some people call us cheap skates, but I don't think our stockholders do. And I always say there's like a greed desperation continuum. And they have to be sufficiently less greedy for us to be able to work out a deal with a potential seller.

And very few are at that stage, but there are a few that we're looking at that we're really interested in. And I think we're really excited about some of the stuff we've got coming up. But we're not going to blow -- we don't need to blow the bank to do it. We've shown that we can take small amounts of capital and create significant pools of long-term value.

Yes, Thomas, when we did the debt deal, too, one of the things we did that was unique is this is -- it was an unsecured notes offering. We went through a rating process that BTIG did a great job leading us through. It gives us sort of a new platform to raise capital quickly on the debt side, too, at a really, really, I think, efficient process, but cost efficient as well. And so that was one of the big reasons we went with the approach we did instead of going the private round. It also allows us to not carry as much debt as maybe we otherwise would have had to on the balance sheet. We've got -- because we have quick access now, especially as the deal presents itself.

We like to -- and Mark and I have that gross leverage ratio target we talked about. When we do deals, if we're going to put up money and it's a commercial stage product, our expectation is it's going to be delevering as well. And we try to structure in that way with the upfront. And like the MELT deal, for example, the way that deal is structured, we have a payment at FDA approval. When that thing launches, we're going to roll right into those customers that are using the MKO MELT. The expectation is we'll make that payment up quickly. We certainly have the cash and availability of liquidity with the ABL to make that payment, plenty of it. But importantly, even if we draw down on the ABL $50 million, immediately, we should be -- it should be a delevering event for the business.

Along the way, I think these ancillary studies that we're going to finance are under $10 million, probably closer to $6 million or so. So for $4.3 million, which is what we put out, an additional investment of a handful or so million dollars, we should be able to get an NDA filed and get to the point where we have an FDA-approved product. And as a substitute for a product that we already sell a lot of units. So that's how we use modest amounts of capital. And I think that will continue to be our approach to inorganic growth.

David Schiller from Arcanum Capital. Question is the access for -- all program, just wanted to maybe talk about how that affects pricing and margins over time.

Well, when you offer a cash pay price, well, let's take a step back to before Access for All. Patients -- I had a friend of mine that went to his pharmacy in Denver, Colorado, he was quoted $800 out-of-pocket cost for VEVYE -- because the prescription was sent to King Soopers Pharmacy in Denver. Whereas if that prescription would have been sent to PhilRx, it would have been accessible at a much lower price. The question is, is that patient -- now my friend happens to be a rich guy. Is that guy who's maybe not as rich going to be able to pay $800 for that prescription month after month after month. And the answer is no. And so what we had to do is design a program, as I said, that worked for all patients, the rich, the poor, the good insurance, bad insurance, no insurance. That's what this does.

Now out of the gate, you do take a margin hit. We saw a larger number of patients go with a $59 prescription. But those patients would have been like my friend that wouldn't have ever gotten it in -- they wouldn't have continued with it to begin with. So we would have lost them. The question is, is how do you, over a long period of time without submitting to these crazy multiyear PBM contracts, profitably address this patient population.

And we think that this Access for All program does that. For us, it's all about a mix. We have some patients that we get commercial coverage on out of the gate or soon thereafter, we do very well on them, right? I mean these patients we make -- you can get $600, $700 reimbursements, Medicare, Medicaid. So we throw those into the mix and then you throw the $59. And when you swirl it around, you do end up with a very attractive ASP SKU, if you will.

Over time, as we get more coverage, we expect that number to rise as opposed to decrease. But right now -- and I'd say since when we modeled out our original net profit per prescription, we're significantly ahead of where we thought when we launched it.

Yes. And one of the -- Mark and I kind of cut our teeth along with John in the Imprimis business, which is cash pay, it's direct distribution. And this is really modeled off of that. So we're eliminating middle people that we're pulling out of that value chain and driving down our profitability on a prescription basis anyways. And that's really the key tenet of the program.

Number one, you increase patient access, but by pulling out all these other middle people and having a great partner with PhilRx in particular, we were able to become more profitable on an everyday prescription. That's something that wasn't the case in the traditional chain. When we look at the expansion of Harrow Access For All, there's going to be products that we make less money on it for sure. There's going to be some -- it's going to sound crazy. There's going to be some we probably do better on. And one of the reasons for that is because of the Medicare -- Medicare Part D typically doesn't pay well for ophthalmology products.

So there's incredible pricing pressure from the payer. And then you throw in the middle people pulling off of that, our profitability on some of these products is really, really low. And so by going direct in some instances, we're actually going to be doing better on some of these products.

I'll add one more thing to that, and Dr. Patel mentioned this as well. Doctors also have to pick and choose sometimes who they're going to prescribe for even in this dry eye category. And I know Paul would agree with me on that. We're capturing a lot of those paid prescriptions, not only in our pharmacy hubs, but also in the retail space for that reason. Doctors don't have to pick and choose which prescription they're sending to the pharmacy because they know one way or the other, the patient has access to the drug.

So they're thinking dry eye is present, dry eye is diagnosed, I'm sending it and it's going to be VEVYE. And then we're getting the benefit that a lot of those prescriptions, again, in the retail space are also being covered now. So I think you made a great point of that earlier, not having to pick and choose and have that added hurdle for both physicians and patients as well.

Yes, there's significant pain as a prescriber when it comes to having to go through this process, right? If there isn't an access program, you are so much more less likely to even think about that drug even when the really well-insured patient comes in the door. It's just not going to happen because you're -- it's just not even on your radar because you can't get it for Tom, Dick and Harry that came in before them with the really bad insurance, right?

And so in my use case, for example, in a given month, I might use 400 or 500 billed IHEEZO injections. I may also use like 100 samples for these patients that have really, really bad insurance or no insurance or what have you. But if I didn't have this program, all of those patients would never have been billed. I would never have used IHEEZO in the first place. Does that make sense? Just so you get a little insight into kind of how we feel from our end.

Just one thing to add to that. I think when you look at -- when we talked about our commercial model, think about all these launches that go out. It's really hard to launch products, right? And I think when you think about it often, when somebody says, I'd like to try to my patient, but right? I go back to the example you mentioned in your practice. It's super important when a doctor writes it that they know the patient can get it confidently because what happens is when you tell your peers, that replicatable experience really takes off for us as an organization and the product performs really well when a peer tells another peer, and that's one of the things that's really important as we go forward in the early stage of our launch is that, one, we remove that barrier that when a doctor makes a choice, they can get it, there's a positive experience.

And then ultimately, we have peer recognition telling other people about the products and recommending them. That's really core with where we're at in our early launch phase and core to our IHEEZO expansion, VEVYE growing, our depth and breadth is really leveraging it where we remove that barrier. So super important for us in the early stage of launch.

Just know, you can't recover from signing a bad PBM contract. That's the bottom line. We are not going to sign bone-headed PBM contracts. They're long-term bad deals. And we're just not in the business of losing money for our stockholders. And we're demonstrating that you cannot sign these stupid contracts and do pretty well.

All right. Maybe one more question, and that's all the time.

Thanks again for doing this day, Mark and company. Four quick questions about BYQLOVI. So number one, for surgeons, what are the 2 highest volume pain relief medications that are being prescribed today? And what are their names? That's question number two. Number three -- number two is what are the volumes for those medications? And then when we compare efficacy for those 2 preferred treatments by surgeons, can you just compare those with their efficacy versus what you discussed with BYQLOVI?

I was going to say 3 doors to your left is probably the guy who's used more topical steroids than anybody in the galaxy. So if you want to pass the mic. [indiscernible] Do you mind talking about topical steroids.

So regarding BYQLOVI, question number one is what are the 2 most frequently prescribed pain relief medications after surgery that are used today.

For steroids after cataract surgery and steroids are most commonly used.

And what is maybe the annual volumes for those 2? And then the third is when you compare those 2 named medications, how do they perform compared to BYQLOVI?

By the way, Dick is the one who told me about clobetasol several years ago and how physicians wanted access to it.

Well, routinely after ocular surgery, we don't prescribe any pain medicine other than to tell the patient, they can take Tylenol or Advil or aspirin, and they do have pain. So if you do a study and you evaluate the patient's pain on the first day or 2 after any procedure, it's meaningful. So they have pain, but typically, we don't prescribe anything. About 3% to 4% of patients do get an opioid. And certainly, there are strong incentives not to use opioids anymore.

And typically, it's a codeine type containing opioid that they obtain. And -- so usually, we don't take care of their pain. So we'd love to do things that make them not have pain because comfortable patients refer other patients and patient word of mouth is still the way most of us grow our practices. So we have something that's safe and effective that we can add to a regimen to make patients more comfortable, that's basically going to be a patient builder. So -- but most of the time, we're not doing anything to be direct.

So when BYQLOVI is available, your guess is when BYQLOVI is available out of every 10 patients, obviously, some complain about pain. What portion might you prescribe BYQLOVI given its benefits and its lack of risk? I mean, would it be 2 out of 10 patients or some other number?

Well, I'm not certain to be direct. So I don't really -- I can't really give you a good solid number there that would be useful for you. I don't think.

But I'll tell you that to add to Dick's point on Dr. Lindstrom's point on that, every patient will get a steroid. Every patient gets NSAIDs typically very commonly topical, which we're talking about also here. But the range is across the board. I mean there are those who will use the -- even like a non-branded prednisolone drop and NSAIDS at times, they'll do compounding through Imprimis where they get all 3 in 1.

There are some that try to go more branded, which I'd say the bromfenac molecule gets used a lot in that category as an NSAID topically, maybe a branded prednisolone rarely DUREZOL anymore just because cataract surgeons are so good at what they do, not a lot of information. But I think that's where that drug will play. Dr. Lindstrom is right. There's not. We're not going to do a lot for the pain specifically, but it could become the alternative if it's shown to be as good and help with pain and help with discomfort, which would have to be studied, of course, to those typical drugs that are out there and even to compounded options, which are of 3 and 1.

By the way, we sell drug through Imprimis for about 1 out of 5 cataract surgeries. Every one of those cataract surgeries gets a topical steroid typically. And what Chad and his team are going to do, I think, is offer both, I think, a best-in-class topical steroid for 100 -- I don't know of many cataract surgery patients that don't receive a topical steroid or a steroid of some kind. He's going to have, I think, the best-in-class topical steroid and then they'll have a best-in-class injectable steroid, all branded.

I just want to add that the value proposition for BYQLOVI is really its anti-inflammatory properties as a steroid, less so as an analgesic, but it does have data for both on label. So that said, really the go-to for BYQLOVI, the reason to go to it is really flares and inflammation.

All right. Well, that's all the time we have for today. So thank you all for coming to our first ever Investor Day, and thank you for all our guest speakers for making the trip.