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Good day, and welcome to the IAccess Alpha Virtual Best Ideas Winter Investment Conference 2025. The next presenting company is Scienture Holdings, Inc. [Operator Instructions] I would now like to turn the floor over to today's host, Narasimhan Mani, President and Co-CEO at Scienture Holdings, Inc. Sir, the floor is yours.

Thank you, Paul. Hello, everyone. Very happy to be presenting our company, Scienture Holdings to you today. We are a NASDAQ-listed company. We were founded about 6 years ago, and we're a specialty branded pharmaceutical company.

So just moving forward, first is a quick snapshot of who we are as a group. Our focus is to be a pharmaceutical product company. Some of the areas where we really dig deep are find values within the pharmaceutical branded space of taking existing molecules, seeing where the deficiencies are in standard of care across therapeutic areas. And we've tried to come out with like better versions, better products that significantly improve the standard of care of the existing molecules.

And there are several situations like that, that we see in the industry, and that's been our focus across our product pipeline. And we bring a lot of experience as part of the management team, our partners, our whole company in terms of R&D, product development, product pipeline and therapeutic area strategy. In addition to the product development and pipeline strategies, we also have launched robust commercial operations where we work with specific partners in terms of branding and promotion channel strategy, placing product in different classes of trades and growing the company from that perspective.

We do have a very accomplished leadership that I'll show you in the next slide between our board and our management team that comes with a lot of years of experience in the industry. It's a quick snapshot of our market presence at the moment. Emerging company kind of done a lot to get to this point, and we look forward to continued growth and what's looming ahead of us is more commercial ops and taking our products to the market.

A quick overview of our executive management and our Board of Directors. I get a lot of experience in the pharmaceutical space, kind of oversight of R&D operations, commercial operations, product portfolio, M&A and we have our Board come with very strong experience running the company. Our core mission, as I mentioned right in the beginning is to find specialty product opportunities, specialty branded opportunities.

Kind of our goal here is not to discover new molecules that we are looking at ways to improve the standard of care we can establish molecules, there often gaps within clinical outcomes, patient convenience, sometimes dealing with adverse events, safety. So we look at all those kind of situations and come with better products based on formulation technology or manufacturing know-how, and that's how we design our products.

We also comprehensively scan their utility right in the beginning within the market space. Is this something that would make sense for patients, that's our biggest guiding mission. And once we believe it will do so, can we successfully or can we conveniently place the product with payers with the various health care systems, be able to build a business around it. I think those are the 2 things that we focus on. And that's what we've been doing in the last 6 years, building our pipeline and then now going commercial with our first 2 products.

And just to kind of give you a snapshot of Scienture LLC subsidiary houses or specialty product programs under our Scienture Holdings parent company. And our goal here is kind of finding ways to come up with specialty brand products. We start with R&D, identifying opportunities. We work with very accomplished partners to do the development, do the FDA filings and take it to approval. And we've also built out, as you'll see in the presentation coming up, commercial capabilities where we can also have the full go-to-market capability. So pretty much from idea to implementation to taking it to the market and continuing to grow commercial, I think you do it all under one roof, and that's the experience that we bring.

And this is a quick snapshot of our product portfolio. I think we're pretty agnostic to therapeutic area. So we have products across cardiovascular, central nervous system, we continue to look for opportunities across different therapeutic areas. But these 5 programs are the ones that we are actively managing and running.

The first program, Arbli, which is an oral losartan suspension is our first NDA that was filed in 2023, got approval earlier this year and has been launched this quarter. REZENOPY, which is the highest strength naloxone, which is a 10-milligram strength, the current marketed on 4-milligram is a commercial product that we acquired and are looking to launch it in the first quarter of next year.

We have 3 development programs at various stages. The first one is for treating migraine. We have a pen device, pen injector product, which has DHE is the active ingredient. Again, a very exciting program continues to move through development. SCN-106 is biosimilar that's a TPA molecule that we use for -- that is being used for stroke and also for treating catheter lines in different hospital situations. And then our fourth product is for a postoperative pain model. We have a long active microsphere product. I think you've been delayed a week or 2 weeks or it's programmable for any duration that we think will be relevant.

So these 5 programs, the first 2 programs are commercial, and we're actively involved in promoting and marketing those products. and we continue our path into development as well. And we continue to look for other opportunities that can accretively add on to this pipeline. We're constantly looking at organic and inorganic opportunities. And all these products come with the proprietary IP, which we continue to file because each of these products has a uniquely selected. We have IP on the actual formulation, that manufacturer, we work with partners, but all of the IP and ownership of the NDA is held by Scienture, held by us. So kind of giving you a snapshot of the different IP landscape that we have filed and continue to file.

And just quickly going on to our first product that we launched in Q4 of this year. This is Arbli losartan potassium oral suspension. It is the first and only approved FDA liquid version of this molecule. Just a quick background on losartan. It's an angiotensin receptor blocker or an ARB the most extensively used ARB in the market in the U.S., more than 70 million prescriptions for hypertension.

So the product exists only as a oral solid tablet at the moment. And looking at the market landscape, we see that close to 3% to 5% of those prescriptions eventually are sent out for compounding into a liquid version. And the reason behind that is the first chief reason is this dysphagia or swallowing difficulties in the chronic medicine, which has to be used continuously or you'll have a situation where patients are hospitalized or on other therapies for which they need a liquid formulation.

The challenges with obtaining a liquid formulation with this product as its inherent chemistry. In the molecule, it's very hard to dissolve. It's a molecule that's very unstable and also needs refrigeration and various other treatments to keep it as a product. So our innovation came with creating a product that's 24-month room temperature stable. At a high concentration, so the patients do not need to have too much volume of the product. And that's how we developed our NDA, and that was our proprietary IP that we filed.

And now we think this has a lot of value to offer to the extremely large space where there are many, many scripts that are being written. But now patients have the reliability of already to use liquid, which is room-temperature stable for 24 months, and it's more easily handled [indiscernible]. So that's kind of the core behind have this product as the first launch.

And just to touch upon our second commercial product, there is about to be launched in Q1 of 2026. This came through as an acquisition opportunity, which we completed in the first quarter of this year. So this is a naloxone 10-milligram product for opioid abuse, and this is the highest trend naloxone in the market. I think the market is currently sold on the 4-milligram the [ narcan ] nasal spray, which I think is pretty commonplace. And there are a few other products also at the formal trend. But there is a segment of the patients here who need either multiple doses of naloxone or need a longer duration of block at a higher -- which a higher string can potentially provide. And also, this can also provide an option potentially for different kinds of agents.

So there's about a 10% to 15% of the population who need a higher dose. And at the moment, if they need a higher dose, you need to take 3 or 4 sprays of the 4-milligram product, which is pretty difficult to manage in an emergency situation. So that's the value of this product. And we are in the process of manufacturing inventory and subsequently looking to build this product by loan to wholesalers by the end of Q1 and be commercial by beginning of Q2 next year.

So that's the background of both of these commercial products. And in terms of commercial infrastructure, I think we have a full-blown strategy of the wholesale distribution side, the promotion side, both inside virtual rep promotion and also free promotion. In addition to that, we're working on patient assistance services, co-pay systems, cash pay options.

So we kind of have the full series of infrastructure built out. We use a 3PL partner for all of our warehousing needs. And we also work across channels. We have the whole retail presence with our virtual and field reps. We also have contracted with institutional GPOs and give us access to hospitals, clinics, long-term care centers.

And then on the payer side, we are contracted with the 3 large national players or commercial coverage. We continue to work getting government and CMS access. So it's a full-blown infrastructure that we have behind commercial operations that continue to fuel growth of this product. And 2026 [ looms ] is a pretty interesting are for us and for all the work of developing and getting product approvals. Now we are in a position to take the product to the market, continue to build revenue margin and have a sound strategy behind it.

And this is providing more information on our contracts and access that we have and various players that we have contracted with to bring the product across channels, across commercial and government coverage. We have a different customer base through GPOs and also our patient assistance programs that we intend to support the product with.

And this again crystallizes what we have in place for Arbli, and what we're looking to do here to taking the product to the market is a retail heavy product. So our promotional efforts are focused on having virtual reps and field sales. We have an entire targeting and segmentation of the U.S. market, try to find the high targeting CPs and beginning that way to place and promote the product. We also have usage on the GPO front, specifically across long-term care centers. So that's some contracts we're looking to leverage.

This product received health care formulary access with the big players as of November, which is another big opportunity for the product receiving coverage. And we continue to use a lot of data-driven approaches to make sure that we're maximizing what this product can do in terms of patient care and also kind of deleverage and utilize them to the highest excess possible. That's what the slide goes over.

And the next 2 slides, I just want to walk you through what's in our pipeline and what's coming up as our next products to the market. The first one is SCN-104. This is a DHE pen injector, dihydroergotamine pen injector, which has an indication for the treatment of migraine. So currently, DHE is a molecule that's used as a therapy across many other -- even though you receive many other drugs, DHE remains as an option to treat as a secondary option or have an attack come through to use it for getting unit.

So if you look at the migraine market, pretty large market, about $9 billion in the U.S. And there are many agents that are used in terms of migraine, you have a new generation CGRP is also available. But DHE is an important piece of the puzzle that can offer therapy for patients. At the moment, DHE is available either as ampules that can be used for self-injection or a nasal sprays. And each of them are predominantly single-use systems which come with their own challenges for patient administration, convenience, variability within patients.

So our product is a much more elegant product. It's an insulin like pen device, which contains doses -- 10 doses in the pen that can be leveraged by the patient across a certain period of time. So with that product, it's a convenient use where you don't have to prepare an injection or you don't have to prepare an ampule in a way to take the dose and it's a much convenient dosage than a nasal spray product. So that's kind of what we've been working on. We expect to file this NDA in the first half 2027 and look to be in the market probably in 2028. So that's our kind of vision with this product. And we think this could be a nice product, nice fit in the market. Because of the needs of migraine patients and our product profile of patient convenience and how we can make the situation better for patients.

SCN-106 is a biosimilar product. Currently, this is this would be a biosimilar to a brand name product called Activase. So Activase contains a TPA molecule, a tissue plasminogen activator. So Activase is indicated for stroke as a primary indication, and then you have a secondary indication was used in cross hospitals as a [ CVAD ] product, meaning that many of the lines that use for treatment, many of the capital lines, intravenous lines, they are flushed with activities, which has a separate brand name called Cathflo Activase to make sure there's no clotting in the system.

So this has 2 indications, and we are developing a biosimilar to this product, and we'll go after the first indication will be the Cathflo Activase indication. But currently, it is just Genentech in the market, offering this product. There are no other biosimilars. We believe we could be the first biosimilar coming to the market with this product. Again, the Cathflo space, the capital in the CVAD space is about a $400 million market size and then the stroke space is close to $1 billion in market size. Pretty good market. We could be the first biosimilar. We expect to file the BLA for this product second half of 2028 and be in the market by 2029. Again, A lot of great work is going on for this product, and we're pretty excited to bring this to the market.

SCN-107 is a long-acting injection products of [indiscernible] and this, again, is a very interesting product that offers postoperative paying support.

And what we are targeting is for a 5-day or a 7-day duration of pain support for patients after going through surgery or other situations for which they are hospitalized can use this product as a long-acting injection. Again, the core technology underlying SCN-107 is a microsphere platform. And we are working with a partner and we have novel polymers that are used to create these market shares. And we have done the initial work on this product. We have met with the FDA. We have a regulatory path established, and we continue to look at moving the project forward across the different clinical trials that are required.

And we're looking to file the NDA on this product in the 2028-2029 time frame once you complete all of the clinical work for this. But again, it is pretty excited exciting product in a very large market space with some unique characteristics providing long-acting pain to patients, which is a non-opioid long-acting thing, which is again a big selling point for this product. With all of our programs in line and beginning with our 2 commercial launches coming up with our portfolio of products entering the market.

And we continue to look for other opportunities to add on to our platform to continue to scale it. We believe we're in a good place to drive revenue and margin beginning 2026. I think with Arbli and REZENOPY launching next year. I think we're very excited to be in revenue. And then we expect to grow those products and have our pipeline products also come through. So we believe we have a good specialty portfolio that has unique products has good patent coverage and also drive value for shareholders and investors.

So pretty exciting times coming up for us. And what I would like to before I sign off here is some of our recent financials where we had -- we are in a position where we have retired all of our debt. So we completed all of that. We have cash along the balance sheet, and we have enough resources to continue our commercial ops continue moving our pipeline products and grow the company even further.

So thank you for your attention. That's what I have for today. Natalia, if you will, please coordinate any questions and anything we need to do from here.

Absolutely. So our first question is, how quickly do you expect Arbli adoption to ramp now that it has formulary access covering around 100 million plus lines and the GPO reach into 2,500 institutions?

Yes. I think that's a pretty good situation to be in. Having covers commercial coverage is a big validation for the product, which improves access and ability for prescribers and patients to confidently go to leverage this product. What we believe is this product continues to be promotion sensitive.

And what we believe is with our deployment of our virtual reps and our field reps beginning this month into Q1 of next year. I think we see a good amount of prescriptions and sales ramping by second quarter, next year, and we believe second half of next year could see a significant ramp-up of our book.

Great. Can you please talk about -- next question is, can you please talk about expected gross margin progression for Arbli as volume, scale and manufacturing efficiencies improve?

Yes. I think where we stand right now, we are at our peak manufacturing efficiency to begin with. I think we have the capability, the scale at which we are operating is pretty large scale economy is already built in. Having said that, this market is about 70 million prescriptions, and we expect about 3% to 4% of that market is our target market.

So we expect to ramp somewhere close to the range of 400,000 to 500,000 prescriptions a year. And at that scale, I think we should starting from about 100,000 right away, ramping up to 400,000 to 500,000, we should definitely have good gross margin improvement. And in terms of pricing and in terms of the unit that we can do, I think over a period of 5 to 6 quarters is when we think we can drive that adoption, drive that growth and have the gross margin improvement.

Great. Our next question is, with the recent debt reduction and $8 million over $8 million in cash, how far does the current capital structure take you operationally?

So we are -- currently, that gives us a runway of close to taking us to Q4 of 2026 with our intended commercial rollout, continue to move some of our pipeline R&D work. So that capital takes us till the end of the year.

And then supplement that, we have revenue coming in, obviously, that we expect to kind of be at a breakeven situation about 10 to 12 months into Arbli and REZENOPY launch. So that will be a good addition. And behind that, we do have our ATM facilities that we used to complement this. But cash that we have right now provides us a runway of about 12 months from now.

Great. Next question is, what key milestones should investors expect ahead of the REZENOPY launch in Q1 2026?

Key milestones for us is strengthening the first 2 milestones is strengthening our patent estate. We have some IP prosecution work that's going on and issuance of IP and also already book IPs. So that's a key milestone that we're working towards. And then we also intend to have our inventory and manufacturing completed by middle to end of Q1.

So we'll have product ready to load into the wholesalers. And we've also started working with several different commercial payers and also with GPO customers so that they will ultimately, we believe this is a lot of an institutional product rather than HCP-driven product. So we began all those activities and hope to have some milestones in terms of payer coverage or signing some big institutional contracts getting close to that.

So those will be the important milestones on the IP side, something to do with the payer access and also trying to line up some of our customers.

Fantastic. And how do you expect REZENOPY to differentiate in the naloxone market, particularly against higher dose competitive products?

Yes. So right now in the market, once we come in, we would be the highest strength available in the market. And the one other product that was available with an 8-milligram strength, which is not currently available in the market. So we come out as the highest strength and what we offer is obviously the -- those segment -- that segment of patients who would need either the multiple doses of the lower strength or because of many other reasons I mentioned before, will need a longer duration of protection before they can get further treatment for their new situation or try to work with patients who need to be -- get relief different range of agents they are using.

So we believe in the high-dose smart head, I think we have a very, very competitive position at 4 milligrams is the current market strength, but within the high-dose, this is probably only us that we expect to really be offering these solutions.

And the last question is, are there any additional specialty costs in the pipeline that you believe could be accretive in 2026 and beyond?

Yes. So we continue to look for opportunities. Specifically, we continue to look for potential commercial opportunities that we can add on to our platform at the moment. We have a fully developed commercial platform, and I think that gives us a unique position to acquire or otherwise in-license or partner on potential commercial opportunities.

We continue to look for those, and we will be looking to see if we can close on any of them within the first 2 quarters of 2026.

There are no further questions. I'll turn it over to you, Mani, for any closing remarks.

Thank you, Natalia. Thanks, everybody, for your attention. And once again, I'm very happy to present our company. I think we have a -- 2025 was a very good year for us, graduating from a development company into the commercial side. And we really look forward to ramping and growing the company from this point forward. Thank you very much.

Thank you. That concludes Scienture Holding, Inc.'s presentation. You may now disconnect. Please consult the conference agenda for the next presenting company.