Kamada Ltd Aktie

Greetings, and welcome to the Kamada Limited First Quarter 2026 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Brian Ritchie of LifeSci Advisors. Thank you. You may begin.

Thank you, operator. This is Brian Ritchie with LifeSci Advisors. Thank you all for participating in today's call. Joining me from Kamada are Amir London, Chief Executive Officer; and Chaime Orlev, Chief Financial Officer. Earlier today, Kamada announced its financial results for the 3 months ended March 31, 2026. If you have not received this news release, please go to the Investors page of the company's website at www.kamada.com.

Before we begin, I would like to caution that comments made during this conference call by management will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Kamada. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, the company's Forms 20-F and 6-K, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, Wednesday, May 13, 2026. Kamada undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.

With that said, it is my pleasure to turn the call over to Amir London, CEO. Amir?

Thank you, Brian. Thanks also to our investors and analysts for your interest in Kamada and for participating in today's call. I'm pleased to report that our operational and financial performance in 2026 is off to a solid start. First quarter revenues and adjusted EBITDA were in line with our expectations.

Importantly, while a temporary shipment delay of a single order, which was already delivered in April, affected our first quarter financial results, the underlying demand for our products continues to increase, supporting our confidence for significantly stronger results over the remainder of 2026. As such, we are reiterating our 2026 annual guidance of $200 million to $205 million in revenues and $50 million to $53 million of adjusted EBITDA, respectively, representing 12% and 23% growth percentage when comparing 2026 guidance midpoint to 2025 results. Importantly, this 2026 annual guidance is based currently solely on organic growth.

We're excited about the growth prospects of our business over both the near and longer term. Our strategy is focused on the expansion of our entire commercial product portfolio, including continued investment in the commercialization and life cycle management of our 6 FDA-approved specialty plasma-derived products, supporting organic commercial growth in the U.S. as well as in ex U.S. markets. As part of our commercial growth, we also anticipate growing our distribution segment through the launch of additional biosimilar products in the Israeli market as well as the expansion of the distribution business to the MENA region.

We further expect to continue ramping up the plasma collection in our three plasma centers, aiming to strengthen our vertical integration, reduce specialty plasma costs and increase revenues through sales of normal source plasma. Lastly, we are focused on securing new business development and M&A transactions, which will enrich our current portfolio of marketed products and generate synergies with our existing commercial operation. I will now expand on each of these strategic growth pillars. Our lead product continues to be our anti-rabies immunoglobulin, KEDRAB, which is being distributed in the U.S. through our collaboration with Kedrion. End user utilization of the product in the U.S. is continuing to increase significantly, and our product supply to Kedrion is expected to increase beyond Kedrion's minimum commitment of $90 million sales in 2026 through 2027. As a reminder, our current supply agreement with Kedrion runs through 2031. In addition to our significant market share in the U.S., we continue to grow sales of KAMRAB in leading international markets such as Canada, Latin America countries, Australia and Israel.

GLASSIA represents our second leading franchise with revenue contribution driven by growing product sales in ex-U.S. markets and royalty income generated from sale of the product by Takeda in the U.S. and Canada. By working diligently with our distributors in key markets such as Argentina, Russia and Switzerland as well as directly in the Israeli market, we are growing our patient base and revenues while continuing to identify and diagnose new patients suffering from AAT deficiency, which is a chronic, highly misdiagnosed disease. We are also continuing to explore opportunities for additional international markets where GLASSIA could be registered and launched. Moving on to our anti-CMV immunoglobulin, CYTOGAM.

Last year, we announced the initiation of a comprehensive post-marketing research program for CYTOGAM, which we believe will help demonstrate the advantages of the product in the prevention and management of CMV disease. We developed this program in collaboration with leading key opinion leaders to explore advancement of novel CMV disease management. I'd like to take this opportunity and talk about two of those investigator-initiated studies. The first study, patients continue to be enrolled into the study titled Strategic Health with Immunoglobulin to Enhance Protection against Late Disease CMV or the SHIELD study. The SHIELD study investigates the benefit of CYTOGAM administrated at the conclusion of the antiviral prophylaxis to reduce the risk of clinically significant late CMV in kidney transplant recipients who are CMV seronegative and have a CMV seropositive donor. These patients are at the highest risk of developing late onset CMV infection, which is associated with the worst transplant recipient health and outcomes.

The second study I'm going to talk supports data, which was recently presented by Dr. Daniel Calabrese, MD, Staff physician in the San Francisco VA Healthcare System and Assistant Professor of Medicine at the UCSF Lung Transplant Programs. It was presented at the 2026 International Society for Heart and Lung Transplant, the ISHLT Annual Meeting in Toronto, Canada. In his presentation, Dr. Calabrese reported data suggesting that CMV may be associated with worse lung transplant outcomes, not only through viral replication, but also through immune activation as the CMV immunoglobulin, the CMV IVIg is associated with immune modulation of this response rather than effect on CMV viremia alone. Dr. Calabrese further reported that in a retrospective analysis of CMV high-risk lung transplant recipients, patients who did not receive the CMV IVIg prophylaxis experienced worse clinical outcomes compared with those who did receive the CMV IVIg prophylaxis and other CMV serotype groups, highlighting the clinical relevance of the high-risk population and the potential role of CMV IVIg as a targeted intervention.

We believe that the data generated by these studies and other studies planned in this program will support increased product utilization for CYTOGAM. Moving on to VARIZIG, our anti-varicella zoster immunoglobulin indicated for post-exposure prophylaxis in high-risk individuals. We are experiencing strong market demand for the product, mainly in Latin America and in the U.S. market, resulting from our product awareness activities and the increase in number of chickenpox outbreaks. As for the distribution sector, -- as part of activities to advance organic growth, we will be launching soon in Israel two additional biosimilars by the end of the second quarter and the beginning of the third quarter, and we have several others in the pipeline to be launched in the coming years. We believe this portfolio will become an increasingly important portion of our distribution business with biosimilars annual sales of between $15 million to $20 million within the next 4 to 5 years.

We are also continuing to advance expansion of our distribution activity to the MENA region. We have recently entered into several distribution arrangements and initiated activities to register the underlying products with local authorities. We continue to engage in discussion with several additional international companies, offering them full service from registration to commercialization. Moving on to Kamada Plasma. In March, we announced FDA approval of our state-of-the-art plasma collection center in San Antonio, Texas, and the center is now geared to commence commercial sales of normal source plasma. With the FDA approval of this center in hand, we plan to seek subsequent inspection and approval by the European Medicine Agency of both the Houston and the San Antonio centers. As a reminder, each of the Houston and San Antonio facilities are expected to generate annual revenues of between $8 million to $10 million in sales of normal source plasma at full capacity. We expect to initiate normal source plasma sales during the second half of this year.

Moving on to business development and M&As. As previously discussed, we continue to evaluate such opportunities, and we're hopeful that this will be able to secure compelling transactions in the near term, which will enrich our portfolio of marketed products and complement our existing commercial operation. We plan that such transaction would generate synergies with our current commercial portfolio and support our long-term profitable growth.

With that, I'll turn the call over to Chaime for a detailed discussion of our Q1 2026 financial results. Chaime, please go ahead.

Thank you, Amir. As Amir stated at the top of the call, results for the first quarter of 2026 were solid and in line with our expectations, exclusive the temporary shipment delay of a single order, which was already delivered during April. Total revenues for the first quarter were $42.5 million, a 3% increase from the $44 million in the prior year period. The increase in revenues year-over-year was primarily driven by increased sales of KEDRAB as well as increased sales in our distribution segment. Gross profit and gross margins were $19.1 million and 42% in the first quarter of 2026 compared to $20.7 million and 47% in the first quarter of 2025.

The reduction in gross margin during the first quarter was affected by products and market sales mix. Operating expenses, including R&D, sales and marketing and G&A and other expenses totaled $12.1 million in the first quarter of the year compared to $13 million in the first quarter of 2025.

The decrease was driven by a reduction in R&D expenses related to the termination of the Phase III InnovAATe clinical trial, which were offset by increases in sales and marketing and G&A expenses related to our investments in the overall growth of the commercial products portfolio. Net income was $4.1 million or $0.07 per diluted share in the first quarter of 2026, up 4% as compared to $4 million and $0.07 per diluted share in the first quarter of 2025. Adjusted EBITDA, as detailed in the table, was $11.6 million in the first quarter of 2026, equivalent to GAAP reported in the first quarter of 2025. As of March 31, 2026, Kamada had cash and cash equivalents of $73.1 million as compared to $75.5 million as of December 31, 2025. Lastly, in March, we were pleased to declare a dividend of $0.25 per share, totaling approximately $14.4 million.

Cash dividend was paid on April 7 of this year. This dividend payment was made in accordance with the dividend policy adopted by the Board under which we intend to distribute an annual dividend of at least 50% of our annual net income, subject to the Board's discretion and satisfaction of dividend distribution tests under the Israeli company's law at the time of distribution. The dividend payment reinforces our confidence in the company's future business, prospects and ample liquidity to continue investing in our commercial growth, including new business development and M&A transactions and dividends to our shareholders.

With that, we are ready to open the call to questions. Operator?

[Operator Instructions]The first question is from Annabel Samimy from Stifel.

This is Jack on for Annabel. Two from us. First, could you give a bit more color on the revenue impact that the delayed shipment had on overall growth and which products were primarily impacted? And at this stage of your diversification, should we expect any seasonality from KEDRAB and VARIZIG? What has kind of kept the growth continuing this far into their product lives?

Thank you for the question. So the delay was with one single shipment. Revenue was approximately $2.4 million. It was supposed to be shipped to one of the ex U.S. territories where we sell our proprietary products, and the delay was primarily because of situation in the Middle East with limited flights to that specific destination. In terms of seasonality, so there is some seasonality regarding KEDRAB in our sales to Kedrion and Kedrion sales in the market. But because we are basically acting as like a B2B type of company because Kedrion carries inventory, so we are less sensitive to that seasonality. Seasonality is because the summertime, people are hanging more out at time that we see greater number of potential exposure to rabid animals. VARIZIG is related more to kind of chicken pox outbreaks. So it's less seasonality, maybe a little bit during the beginning of school year in September. but again, not significantly fluctuating. So it's more about when there are outbreaks, this is where our product is needed more.

The next question is from Jim Sidoti from Sidoti & Company.

With the distribution business, can you tell us how many products are approved for sale right now?

In total, in the Israeli market, Kamada has around 40 different products which we distribute. We service around 20, 20-plus different international companies. We are growing the biosimilars segment. We are working with multiple companies. In the past, we announced that we have an agreement with Alvotech. Since then, we've added additional companies that we present in Israel for the biosimilar segment. We have launched already three products, two more will be launched over the next few weeks. So we already have five products in the market by end of this year on the biosimilar side.

In the MENA region, we are expanding. We already signed multiple agreements to represent companies in the region, and we will be continuing to sign agreements and to register the products, and those products expected to be launched second part of this year into 2027. The first few products that we will be selling in the MENA region under a distribution agreement.

Okay. But -- so the total number of products by the end of the year should be approximately 45 products?

Approximately, yes. But there is a significant kind of variance between the level of the sales of each one of those products. Some products sells millions of dollars, some sell hundreds of thousands of dollars.

So the increase in the first quarter, is that primarily because of the addition of the three products you added so far? Or is that also...

It was across basically the entire portfolio that we have seen. It wasn't based on one single product.

Okay. And for the plasma collection business, you indicated you're going to start selling source plasma right at the end of the year. So does that mean that you're right now close to collecting whatever plasma you need for your proprietary products at this point?

No. It's -- each one of the centers started by collecting normal source plasma. That's kind of the first step for a new center once it was established. And then we are adding specialty programs to the Houston and San Antonio centers. The Beaumont center is collecting only specialty, and that has been since the day we acquired this center in 2021. So this is not one on account of the other. These programs are running in parallel. The fact that now we have FDA approval for both Houston and San Antonio allows us to sell the normal source plasma that we've already collected since we opened those centers, and that's a sale that will be materialized starting second part of this year.

I will pass the call over to Brian Ritchie.

Thank you. Just a couple of questions that have come in online. Amir, on the plasma collection centers, can you let us know when the Houston and San Antonio centers will reach full collection capacity?

Yes. So we expect to be running at full capacity towards the end of 2027, early 2028 on the normal source, definitely on the specialty, we'll continue to collect and add more and more donors. So let's say, end of '27, early '28, this is when the centers expected to be running at their current planned capacity.

And the last question here has to do with CYTOGAM. What are the current trends currently impacting that particular product?

So as I mentioned during the call, we are making efforts investing in expanding the post-marketing clinical program. I mentioned on the call that we just had a strong basically report coming from Dr. Calabrese from UCSF was presented at ISHLT conference. And Dr. Calabrese basically showed a study that was made that basically highlighting the clinical relevance of CYTOGAM of CMV, IVIg as a potential targeted intervention for high-risk transplanted patients. This is in addition to other data that we've been collecting and presenting over the last few years since we acquired the product and started investing in the post-marketing clinical studies. We believe that the data generated by these.

Studies, and this is in addition to the SHIELD study that it will take a bit longer to see the data and other studies that we are running through investigator-initiated type of programs will support increased product utilization for CYTOGAM. So we think that the weakness of the -- that we were facing when we acquired the product was a lack of recent clinical data and that the investments we are making in the product life cycle management in order to show the benefit advantages of the product to be used in parallel to the antivirals and actually improve patient outcome.

Thanks, Amir. Appreciate that comprehensive answer. And with that, I'll turn it back to you for closing remarks.

Okay. Thank you, Brian. So in closing, we continue to invest in the 4-pillar growth strategy with continued progress made in the organic growth of existing commercial portfolio, expansion of distribution business, growth of our plasma collection operation and securing business development and M&A transactions to support and expedite our growth.

We look forward to continuing to support clinicians and patients with important products that we develop, manufacture and commercialize. And we thank you all for your support, and we remain committed to creating long-term shareholder value. So thank you for participating in today's call, and we hope you all stay healthy and safe. Thank you.

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Greetings, and welcome to the Kamada Limited Fourth Quarter 2025 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the call over to Brian Ritchie, Managing Director of LifeSci Advisors. Thank you. You may begin.

Thank you. This is Brian Ritchie with LifeSci Advisors, and thank you all for participating in today's call. Joining me from Kamada are Amir London, Chief Executive Officer; and Chaime Orlev, Chief Financial Officer. Earlier today, Kamada announced its financial results for the 3 months and year ended December 31, 2025. If you have not received this news release, please go to the Investors page of the company's website at www.kamada.com. Before we begin, I would like to caution that comments made during this conference call by management will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Kamada.

I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, the company's Forms 20-F and 6-K, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, Wednesday, March 11, 2026. Kamada undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. With that said, it is my pleasure to turn the call over to Amir London, CEO. Amir?

Thank you, Brian. My thanks also to our investors and analysts for your interest in Kamada and for participating in today's call. I'd like to begin by noting that while the situation in the Middle East continues to evolve, Kamada's operation and product manufacturing are proceeding as planned, and our plant is operating continuously, although exports from Israel may be temporarily impacted due to the recent closure of Israeli airspace, cargo flights have gradually resumed and we do not anticipate material disruption to product supply.

We continue to closely monitor situation and remain fully committed to meeting our supply obligations. I'm pleased to report that operational and financial performance in 2025 was excellent and that we continue to generate significant profitable growth. Total revenues for the year were $180.5 million, representing a 12% year-over-year increase and adjusted EBITDA was $42 million, up 23% year-over-year. Results for the year were well within our 2025 annual guidance and a testament to our ability to execute on our strategy and generate significant profitable growth through the diversity of our commercial product portfolio.

We also demonstrated our ability to convert profitability to operational cash flow, generating $25.5 million of cash from operating activities for the year contributing to a strong cash position of $75.5 million at year end of 2025. On the strength of our 2025 results, the Board and Kamada management are pleased to declare a dividend of $0.25 per share, totaling approximately $14.4 million, payable on April 6 to shareholders of record as of March 23. This dividend payment is made in accordance with the dividend policy adopted by our Board under which we intend to distribute an annual dividend of at least 50% of our annual net income subject to the board discretion and satisfaction of the dividend distribution test under the Israeli Companies law at the time of distribution.

This dividend payment reinforces our confidence of the company business prospects and ample liquidity to continue investing in our commercial growth, including the continued pursuit of new business development and M&A transactions while also paying dividends to our shareholders. We entered 2026 with a position of significant strength continuing to benefit from growth across our entire portfolio based on a positive outlook and consistent -- of $200 million to $205 million in revenues and $50 million to $53 million of adjusted EBITDA, which respectively represent 13% and 23% growth when comparing 2026 guidance midpoint to 2025 results. Importantly, this 2026 annual guidance is based solely on organic growth. We're excited about the growth prospects in our business over both the near and longer term.

Our strategy is focused on the expansion of our entire commercial product portfolio, including continued investment in the commercialization and life cycle management of our 6 FDA-approved specialty plasma-derived products supporting organic commercial growth in the U.S. and in ex U.S. markets. We also anticipate growth of our distribution segment through the launch of additional biosimilar products in the Israel market as well as expansion of the distribution business to the MENA region. We further expect to continue ramping up the plasma collection in our 3 plasma centers, aiming to strengthen our vertical integration, reduce specialty plasma costs and support continued growth through sales of normal source plasma.

Lastly, we are focused on securing new business development and M&A transactions which we expect will enrich our current portfolio of marketed products and generate synergies with our existing commercial operation. Our lead product continues to be our anti-rabies immunoglobulin, KEDRAB, which is being distributed in the U.S. through our collaboration with Kedrion. Sales of the product to Kedrion increased in 2025 to approximately $54 million, well above the contract minimum commitment. We have a firm commitment of $90 million from Kedrion for minimum orders from 2026 through 2027 and our current supply agreement with them runs through 2031. In addition to our significant market share in the U.S. we continue to grow sales of KAMRAB in leading international markets such as Canada, Latin American countries and Israel.

GLASSIA represents our second leading franchise with total revenue contribution of $35 million, split between our growing product sales in ex U.S. markets and royalty income generated from sale of the product by Takeda in the U.S. and Canada. Moving on to our anti-CMV immunoglobulin CYTOGAM, revenues from the product declined in 2025. We believe the decline was primarily due to increased usage of antivirals such as the letermovir and maribavir resulting from improvements in their market access coverage. As you may recall, in 2025, we announced the initiation of a comprehensive post-market and research program for CYTOGAM, which we believe will help demonstrate the advantages of the product in the prevention and management of CMV disease.

Although CMV disease continues to be a significant risk factor for organ rejection and mortality in transplantation, for years, no new up-to-date to the clinical data regarding the benefit of CYTOGAM were published. To address this, we developed this program in collaboration with leading key opinion leaders to explore advancement of novel CMV disease management. Last October, we announced the enrollment of the first patient in an important investigator-initiated trial included in this program, the study titled Strategic Health with immunoglobulin to enhance protection against late disease CMV or the SHIELD study is a prospective, randomized, controlled multicenter investigator-initiated study in CMV high-risk kidney transplant recipients.

The SHIELD study will investigate the benefit of CYTOGAM administered at the conclusion of the antiviral prophylaxis to reduce the risk of clinically significant late CMV in kidney transfer recipients who are CMV seronegative and have a CMV seropositive donor. These patients are at the highest risk of developing late onset CMV infection, which is associated with worse transplant recipient health and outcome. The study is being conducted by leading expert in CMV and organ transplantation, Dr. Camille Kotton, Infectious Disease specialist and Clinical Director of transplant and immunocompromised host infectious disease at Massachusetts General Hospital; and Dr. David Wojnowski, Medical Director of the Kidney Transplantation Program at the University of Texas Southwestern Medical Center.

We are very pleased we'll be working with such notable experts in the field, and we believe that the data generated by this study and other studies planned in this program will support increased product utilization for CYTOGAM. Also, as part of activities to advance organic growth following the first 2 biosimilar product launches in Israel during 2024 and 2025, we will be launching in Israel, 2 additional biosimilars in the coming months and have several others in the pipeline to be launched in the coming years. We believe this portfolio will become an increasingly important portion of our distribution business with biosimilars annual sales of between $15 million to $20 million within the next 4 to 5 years.

During 2025, we've also commenced expansion for distribution activity to the MENA region with initial agreements already signed. In addition, we are ramping up plasma collection into our Houston and San Antonio plasma collection centers. Both facilities include 50 donor beds with a planned peak capacity of approximately 50,000 liters per year each and are anticipated to be 2 of the largest collection centers for specialty plasma in the U.S. The Houston site is already FDA approved, and we expect our San Antonio site to receive FDA approval during the first half of 2026. As previously stated, each of those 2 centers is expected to generate annual revenues of $8 million to $10 million in sales of normal source plasma at full capacity.

Moving to business development and M&A. We are currently pursuing new opportunities, and we are hopeful that we would be able to secure compelling in-licensing, collaboration, and/or M&A transactions, which will enrich our portfolio of marketed products and complement our existing commercial operation. We anticipate that such transactions will generate synergies with our current commercial portfolio and support our long-term profitable growth. With that, I will turn the call over to Chaime for a detailed discussion of our financial results for 2025. Chaime, please go ahead.

Thank you, Amir. As Amir stated at the top of the call, we reported strong results for the year ended December 31, 2025. Total revenues for 2025 were $180.5 million, a 12% increase from the $161 million generated in 2024. Revenue growth for 2025 over 2024 was attributable to growth across our portfolio, especially increased sales of VARIZIG and KEDRAB in the U.S. market, KAMRAB and GLASSIA, in ex U.S. market and an overall increase in sales in our distribution segment through the launch of biosimilars and other products in our portfolio.

In December, we announced a $10 million to $14 million extension of an existing tender from the Canadian blood services. For the supply of WINRHO, HEPAGAM, CYTOGAM, and VARIZIG for an additional 2 years. This award secures ongoing sales of these products in the Canadian market between the second quarter of 2026 and the first quarter of 2028. Gross profit and gross margins for 2025 were $76.4 million and 42%, respectively, compared to $70 million and 43%, respectively in 2024. The increase in gross profit is in line with the increase in total revenues, whereas the decrease in gross margin is due to product and market sales mix. Operating expenses, including R&D, sales and marketing, G&A and other expenses totaled $50.2 million in 2025 as compared to $49.9 million in 2024.

Whereas the reduction in R&D expenses year-over-year was related to the decision to discontinue the inhaled AAT clinical study and the increase in G&A expenses was required in order to support the increased commercial operation. Net income for 2025 was $20.2 million or $0.35 per diluted share, a 40% increase as compared to the net income of $14.5 million or $0.25 per diluted share in 2024. Adjusted EBITDA was $42 million in 2025, a 23% increase as compared to $34.1 million in 2024. Our ability to generate significant profitable growth is indicative of the diversity of our portfolio and our successful marketing activities across different territories and medical specialties. As of December 31, 2025, Kamada had cash and cash equivalents of $75.5 million as compared to $78.4 million in December of 2024.

The company generated $25.5 million from operating activities and recorded net cash used in investment activities of $9.8 million and net cash used in financing activities of $18.3 million. collectively resulting in the overall decrease in cash balance. With respect to the results for the quarter ended December 31, 2025, we can indicate that the revenue increase quarter-over-quarter is consistent with the performance throughout 2025, whereas the reduction in gross margin during the fourth quarter is related to a change in product end market sales mix. And together with the increase in operating expenses supporting the overall increase in our commercial operation contributed to the overall decrease in net profitability and adjusted EBITDA quarter-over-quarter. That concludes our prepared remarks. We will now open the call for questions.

[Operator Instructions] Our first question comes from the line of Annabel Samimy with Stifel.

Hi, everyone, and great end to the year. I want to ask a few questions. I guess the first one I wanted to ask about the CMV market and whether you mentioned that the reduction in CYTOGAM was due to increased access of antivirals. Is there any change in the protocol for CMV? Or is there any improvement in the actual efficacy of the antivirals that would change your opportunity at all? Or is it status quo and this is just a matter of increased access and same protocols.

Annabel, we are not aware of any change in the protocol of CMV management. We do know, and we did follow some of the antiviral providers announcement that they had strong 2025 as a result of better market access. And we believe that there might be some insurers that have not covered the antiviral treatment in the past, and now they are covering it, and this might have some effect on CYTOGAM usage during 2025. Having said that, I would like to emphasize that we still strongly believe in the need for CYTOGAM as an additional protection for the high-risk organ transplant recipients.

And the work that we started doing in 2025 we believe that, that medical and clinical work will show the unique properties of CYTOGAM and the advantages to administer CYTOGAM in addition to the antivirals, kind of doubling the protection against CMV infection. With that regard, I'd like also to mention that while CYTOGAM usage during recent years was primarily for lung and lung and heart recipients. The clinical work we are currently doing and specifically the SHIELD study is performed on kidney transplantation which, as everyone knows, consists of the majority of solid organ transplant in the U.S. is over 50% of such procedures. As such, we are confident that successful results from these studies can yield a significant increase in CYTOGAM usage.

Okay. Perfect. And just separately, I wanted to ask you, of course, I have to ask you about M&A. I imagine that the dividend since it's part of your policy is not indicative of any change in the potential opportunities that you have for M&A or business development? Or am I wrong to think that?

No, you're absolutely correct. The dividend payment reinforce our confidence in our business prospects, and we believe that we have sufficient funds and liquidity to continue investing in the commercial growth as well as M&A transactions, while also paying dividend. We are progressing in our pursuit of M&As, and we are optimistic that we'll be able to secure such a transaction already in 2026. I'd like to remind everyone that the guidance we gave for 2026 is based on organic growth and any potential transaction will accelerate the growth for this year.

Okay. And one last question, if I may. Just as far as the plasma collection. At what point should we expect gross margin benefit from the proprietary plasma collection for specialty plasma specifically. Just wanted -- I know that the plasma centers are still in the process of getting approved by FDA, but do you have a timing on when we can expect gross margin impact.

Yes. So as I said, Beaumont and Houston already FDA approved, San Antonio expected to be approved within the next few months during H1 2026. We expect to start selling normal source plasma in the second part of this year once the centers are approved. And in terms of specialty plasma, we expect now to continue ramping up our collection, and this will start to have effect on our gross profit starting 2027 and beyond.

[Operator Instructions] Our next question comes from the line of Jim Sidoti with Sidoti & Company.

All right. Just following up on the plasma collection centers. Can you give us a sense on how quickly they have been ramping up? Are they at you'd say, 25% production levels right now, 30% or? And how quickly do you get up to 100%.

Around between 30% to 40% ramped up. Right now, we believe it will be at full ramped by end of 2027. And -- but of course, during that period, we will also start selling normal-source plasma to external parties and use our own -- specialty plasma for own use.

All right. And on the distribution business, I think you indicated you have 2 more biosimilars that you'll introduce in 2026. Can you give us a sense on the timing? Is that -- is that a second half of the year event? Or do you think those will be on the market a little bit sooner?

They're expected to be launched around midyear, maybe kind of end of Q2. So the impact will be during the second part of the year.

Okay. And when those products are launched, is there an initial stocking orders? Or is that kind of -- does it take a little longer for those to ramp up sales of those products to ramp up?

Not material stocking. So it goes by market demand, the hospitals itself might buy kind of initial quantity, but it's going to be based on actual consumption in the market.

Right. And then the double-digit growth you're projecting for 2026, can you just give us a sense, is that primarily expanding into new geographies? Or do you expect that rate of growth in the U.S. as well?

Including in the U.S.. So we expect it that's across our entire portfolio and entire kind of geographies. So...

Okay. And one last one. The dividend, will that be the $0.25, the entire $0.25 be paid out in the first quarter? Or will that be spread out over the year?

One moment, please. We're experiencing some technical difficulties. One second. Mr. Orlev, you're now connected again.

Okay. Yes. No, I was just asking on the dividend. Will the entire $14 million, will that be paid out in Q1? Or is that...

Let me try and reconnect. One moment. Mr. London, please go ahead.

Yes, I apologize, we got disconnected. Jim, can you hear me?

Yes, I can.

Yes. So can you repeat your question, please?

Yes. I was just asking on the dividend. Will the entire $14 million be paid out in the second quarter? Or is that going to be on a quarterly basis?

Everything will be paid one time in the second quarter. Again, I apologize for this being disconnected.

Thank you. I'll turn the floor back to [indiscernible]

Thank you, operator. Amir, we just had one question that already addressed. It came in writing. Is question regarding VARIZIG and how its performance in '25 and the go-forward prospects for that product.

Yes. So we're very happy with VARIZIG performance in 2025. We've seen a significant increase. We believe that the decline in vaccination rates, particularly in the U.S. as well, which resulted in an increase of number of chickenpox outbreaks and the marketing and medical work that we've been doing in the field to increase awareness of the importance of using VARIZIG with immunocompromised population that have been exposed to those outbreaks had a significant contribution to the increase in VARIZIG sales.

We expect this trend to continue in 2026, reminding all the listeners that we won a significant tender for VARIZIG by the WHO for the Latin American region. So this is part of our growing this product in the U.S. and ex U.S. market.

Thank you, Amir. Operator, I think we are ready to close the call.

This concludes our question-and-answer session. I'll turn the floor back to Mr. London for any final comments.

Thank you very much. So in closing, we continue to invest in the 4-pillar growth strategy, with continued progress made in organic growth of our existing commercial portfolio. Expansion of our distribution business, expansion of our plasma collection operation and working on securing business development and M&A transaction to support and expedite our growth. We look forward to continuing to support clinicians and patients with important life-saving product that we develop, manufacture and commercialize. We thank you all for your support and remain committed to creating long-term shareholder value. Thank you very much. We hope you all stay healthy and safe.

Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

Greetings, and welcome to Kamada Corporate Update Conference Call. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Brian Ritchie, Managing Director of LifeSci Advisors. Thank you. Please go ahead.

Thank you. This is Brian Ritchie with LifeSci Advisors, and thank you all for participating in today's call. Joining me from Kamada are Amir London, Chief Executive Officer; and Chaime Orlev, Chief Financial Officer.

Earlier today, Kamada issued a press release announcing the company's decision to discontinue its Phase III inhaled AAT InnovAATe clinical trial, while providing an update on its financial projections, which are the subject of today's corporate update call. If you have not received this news release, please go to the Investors page of the company's website at www.kamada.com.

Before we begin, I would like to caution that comments made during this conference call by management will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Kamada. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, the company's Forms 20-F and 6-K, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.

Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this -- of the live broadcast, Monday, December 8, 2025. Kamada undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. With that, it is my pleasure to turn the call over to Amir London, CEO. Amir?

Thank you, Brian. My thanks also to our investors and analysts for your interest in Kamada and for participating in today's call. I will provide a brief update on today's news, and we will then open the call for questions.

As Brian mentioned, this morning, we issued a press release announcing the discontinuation of our Phase III inhaled AAT InnovAATe clinical trial due to futility. The independent unblinded, DSMB advised us that based on the prespecified interim futility analysis, which the company has requested the InnovAATe trial of Inhaled AAT for the treatment of Alpha-1 deficiency is unlikely to demonstrate a statistically significant benefit in its primary endpoint of lung function as measured by FEV1. Based on this outcome, we are discontinuing this program.

This decision is solely related to the limited likelihood of a successful efficacy outcome should the study continue to conclusion, and it is not reflective of any safety concerns related to the inhaled AAT treatment. We are taking the appropriate steps to inform all participating sites of our decision to discontinue the study in an organized and efficient manner.

We are grateful for the support of the patients who participated in the study, the Alpha-1 community, physicians, clinical site teams, regulators and all stakeholders who contributed to the study. Importantly, we, Kamada remain committed to the Alpha-1 community through continued supply of Glassia, our leading AAT-IV treatment marketed internationally, including in the U.S. and Canada through our license agreement with Takeda.

While we are disappointed that the trial did not pass this milestone and it is being discontinued, it's important for me to clearly emphasize that our business remains very strong, and we are well positioned to continue and support our 2026 and future growth prospects even without the inhaled AAT products. I take this opportunity to also reiterate that based on our consistent strong performance during 2025, we are on track to meet our full year 2025 revenue guidance of between $178 million to $182 million and our annual adjusted EBITDA of between $40 million to $44 million.

As for 2026, we project double-digit growth in revenues and profitability through our robust commercial portfolio, including 6 FDA-approved specialty plasma-derived products marketed in over 30 countries, our growing biosimilar portfolio in Israel and the expansion of our plasma collection capacity. The detailed financial guidance for 2026 will be provided soon in early January.

Importantly, in addition to our strong organic growth, we continue to focus on pursuing attractive new commercial stage business development opportunities, leveraging our strong cash position to support continued long-term profitable growth.

That concludes my prepared remarks. Operator, we are ready to open the call to questions.

[Operator Instructions] Our first question today is coming from Jim Sidoti of Sidoti & Company.

Can you tell us what was the cost of conducting the trial? And how quickly do you think those costs will fall off?

Thank you, Jim. So annual study costs during recent years were between $5 million to $6 million per year. In early 2026, we will still require some budget for the study closure activities. But beyond that, those costs will be eliminated and our EBITDA will grow accordingly.

Okay. And do you expect anything in the near term to offset that? Or do you think that should -- that $5 million to $6 million of annual costs should fall through to the bottom line?

All the way to the bottom line.

[Operator Instructions] At this time, I'd like to turn the floor back over to Mr. London for closing comments.

Thank you very much, operator. So in closing, we continue to invest in our growth strategy, with continued progress made in organic growth of our existing commercial portfolio, business development and M&A transaction to support and expedite our growth and the expansion of our plasma collection operation. We look forward to continuing to support clinicians and patients with the important life-saving products that we develop, manufacture and commercialize. We thank you all for your support and we remain committed to creating long-term shareholder value. Thank you. Have a good day.

Ladies and gentlemen, this concludes today's event. You may disconnect your lines or log off the webcast at this time, and enjoy the rest of your day.

Good morning. Welcome to Kamada Limited Third Quarter 2025 Earnings Conference Call. [Operator Instructions] Please note this conference is being recorded.

At this time, I'll turn the conference over to Brian Ritchie with LifeSci Advisors. Thank you, Brian. You may now begin.

Thank you. This is Brian Ritchie with LifeSci Advisors. Thank you all for participating in today's call. Joining me from Kamada are Amir London, Chief Executive Officer; and Chaime Orlev, Chief Financial Officer. Earlier today, Kamada announced its financial results for the 3 months and 9 months ended September 30, 2025. If you have not received this news release please go to the Investors page of the company's website at www.kamada.com.

Before we begin, I would like to caution that comments made during this conference call by management will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Kamada. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, the company's Forms 20-F and 6-K, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.

Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast Monday, November 10, 2025. Kamada undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.

With that said, it's my pleasure to turn the call over to Amir London, CEO. Amir?

Thank you, Brian. My thanks also to our investors and analysts for your interest in Kamada and for participating in today's call. I'm pleased to report that our results for the third quarter and first 9 months of 2025 were strong, and that we continue to generate significant profitable growth.

Total revenues for the first 9 months of the year were $135.8 million, representing an 11% year-over-year increase and adjusted EBITDA was $34.2 million, up 35% year-over-year representing a 25% margin of revenues. We expect to continue generating profitable growth through the remainder of 2025. And based on our positive outlook, we are reiterating our annual revenue guidance of $178 million to $182 million and adjusted EBITDA guidance of between $40 million and $44 million, representing double-digit growth over our 2024 results.

We are excited for the growth prospects in our business, over both the near and longer term, guided by our 4-pillar growth strategy, including organic commercial growth, with development and M&A transactions, for plasma collection operation and the advancement of our pivotal Phase III inhaled AAT program. Our lead product continues to be our anti-rabieglobuline cadre which is being distributed in the U.S. through our collaboration with Kedrion from which we have a firm commitment to minimum orders for 2025 through 2027 and where the supply agreement with them further extends through 2031.

In addition to our significant market share in the U.S., we continue to grow sales of the product in leading international markets such as Canada, Latin American countries and a few Asian markets. Revenue growth for the first 9 months of the year compared with the first 9 months of 2024 was primarily attributable to the increased sales of Glassia, our AAT IV product in ex U.S. markets, mainly Latin America and the CIS region. In addition to our sales in those countries, the product continues to generate royalty income on sales by Takeda in the U.S. and Canadian markets. Our ability to generate significant profitable growth is indicative of the diversity of our portfolio and our successful marketing activities across different territories and medical specialties.

Moving on to our anti-CMV immunoglobulin CYTOGAM. As you may recall, earlier this year, we announced the initiation of a comprehensive post-marketing research program for CYTOGAM which we believe will help demonstrate the advantages of the product in the prevention and management of the CMV disease. Although CMV continues to be a significant risk factor for organ rejection and mortality in transplantation for years, no new up-to-date clinical data regarding the benefit of CYTOGAM were published.

To address this, we developed this program in collaboration with leading key opinion leaders to expel advancement of novel CMV disease management. In October, we announced enrollment of the first patient in an investigator-initiated trial included in this program. The trial called Strategic Health with Immoglobalin to enhance protection against late CMV disease or SHIELD is a prospective, randomized, controlled multicenter investing initiate study in CMV high-risk kidney transplant recipients.

The SHIELD study, we investigate the benefits of Cytogam administrated at the conclusion of the antiviral prophylaxis to reduce the risk of clinically significant late CMV in kidney transport to CPNs who are CMV negative and have a CMV seropositive donor. Those patients are at the highest risk of developing late onset CMV infection which is associated with worst transplant to CPN health and outcomes. We are very pleased to be working with notable experts in this fisoand we believe that the data generated by this study and others plans for this program will support increased product utilization for cytogram, leading to organic growth.

Also, as part of activities to advance organic growth, following our first biosimilar product launch in Israel last year, which is expected to generate approximately $2.5 million in revenues in 2025, we will be launching 2 additional biosimilars in the coming months and have several others in the pipeline to be launched in the coming years. We believe that this portfolio will become an increasingly important portion of our distribution business with annual sales of between $15 million to $20 million within the next 5 years.

Moving to business development and M&A. We continue to conduct active due diligence over several potential commercial targets. During early part of 2026, we expect to secure compelling in-licensing, collaboration and/or M&A transactions, which will enrich our portfolio of marketed products and complement our existing commercial operations. We anticipated such transactions will generate synergies with our current commercial portfolio and support our long-term profitable growth.

In addition, we are ramping up plasma collection at our Houston and San Antonio plasma centers. post facilities support 50 donor beds with a planned peak capacity of approximately 50,000 liters per year each and are anticipated to be 2 of the largest collection centers for specialty plasma in the U.S. A few weeks ago, we announced that the Houston facility already received FDA approval, and we expect the San Antonio site to follow in early 2026.

We intend to seek subsequent inspection and approvals from the European Medicine Agency in the EMA of both sites. We are currently engaged in discussion with potential customers to secure long-term sales agreements for normal source [indiscernible]. As previously stated, each of those 2 centers is expected to generate annual revenues of $8 million to $10 million in sales of normal source plasma at full capacity.

Turning now to our ongoing pivotal Phase III InnovAATe clinical trial for inhaled Alpha-1 Antitrypsin therapy. We continue to advance this program with its revised enrollment goal of approximately 180 subjects and we are on track to complete an interim futility analysis and announced its results by the end of this quarter.

With that, I'll now turn the call over to Chaime for a detailed discussion of our financial results for the third quarter and 9 months of 2025. Chaime, please go ahead.

Thank you, Amir. As Amir stated at the top of the call, we reported strong results for the quarter and 9 months ended September 30, 2025. Total revenues were $47 million in the third quarter of '25, up 13% compared to $41.7 million in the third quarter of '24. Total revenues for the first 9 months of 2025 were $135.8 million, an 11% increase from the $121.9 million generated in the first 9 months of 2024. The increase in revenues was driven by the diversity of our product portfolio primarily attributed to increased sales of glass in ex U.S. markets, increased sales driven by our Distribution segment and VARIZIG sales in the U.S. market.

It is important to note that we continue to achieve double-digit growth even through the expected decline in glass and royalty income as a result of the reduction in the royalty rate that went into effect during the third quarter. Gross profit and gross margins were $19.8 million and 42% in the third quarter of '25 compared to $17.2 million and 41% in the third quarter of '24. For the first 9 months of 2025, gross profits were $59.4 million and 44% compared to 52.9% and 43% in the first 9 months of 2024. The increase in both matrices is in line with the continued improvement of product sales mix and the overall increase in our commercial scale.

Operating expenses including R&D, sales and marketing and G&A and other expenses totaled $11.9 million in the third quarter of 2025 similar to the level reported in the third quarter of 2024. Operating expenses totaled $36.8 million in the first 9 months of 2025 as compared to $38 million in the first 9 months of 2024. The decrease is mainly related to a reduction in R&D expenses, which was related to development project timing changes.

Net income was $5.3 million or $0.09 per diluted share in the third quarter of 2025, up 37% as compared to the third quarter of 2024. Net income for the first 9 months of 2025 was $16.6 million or $0.29 per diluted share up 56% compared to the first 9 months of 2024. Adjusted EBITDA was $11.7 million in the third quarter of 2025, up 34% over the third quarter of 2024. For the first 9 months of 2025, adjusted EBITDA was $34.2 million, a 35% increase compared to the first 9 months of 2024. It should also be noted that the adjusted EBITDA for the first 9 months of 2025 was equal to the reported -- to that reported for the full year of 2024.

For the first 9 months of 2025, cash provided by operations was approximately $17.9 million that contributed to the strong cash position of $72 million at the end of the quarter.

That concludes our prepared remarks. Operator, we're ready to open the call for questions.

[Operator Instructions] And our first question comes from the line of Annabel Samimy with Stifel.

Great progress on operations. I want to know a little bit more about the CYTOGAM study and how this differs from the clinical data that's already been -- that you've been using for clinical education so far what this adds to the package. And I guess maybe you can sort of talk about the population that does have this late onset CMV, do you now have enough information to cover the totality of the transplant population with the prior, I guess, studies that were conducted.

Annabel, thank you for the question. So the main difference between the current treatment population of CYTOGRAM and this SHIELD study is it currently CYTOGAM is primarily used either prophylactically at the time of the transplantation as part especially for high-risk patients. which are donor-positive recipients negative. Or as part of treatment, if there is actual active disease of patients a few days or weeks into the cost transplantation, while the SHIELD study is going to test using CYTOGAM as part of late CMV after patients have been treated for a few months with antivirus that point, the physicians start streaming down the antiviral usage, and that's a risk for a flare of CMV disease for the patient.

So this is basically kind of a prophylactic usage at late stage after transplantation as part of trimming down the antiviral usage. What percentage? I don't remember the top of my head. I would like to say on 20% but I will check this and get back to you.

Okay. Great. That was helpful color. Then I guess I'm also curious about ATD where you are with enrollment, clearly, there's a lot -- there's an increasing number of programs right now that are under development. aside from gene therapy, there's some RNA editing options as well. So how is that impacting your enrollment? And are you still -- I mean, I know you're on target for the interim study, for interim analysis, how is the enrollment completion time line looking and top line data.

Okay. Good. So enrollment is continuing. As you say, that's an orphan disease and because we are the studies with the placebo arm. So recruitment has been a challenge since the study started and continues to be a challenge. We are at around 60%, 65% enrollment currently compared to the reduced sample size for the study. We do see some competition from other studies, but the sites where we are working with active sites are highly committed to the [indiscernible] study.

As you said, we will have the futility and [indiscernible] resolved before the end of the year. expect those results if they are positives in terms of continuing the study to give kind of strong backwind to the study and allow us to expedite recruitment. We expect to complete recruitment by early '27 which mean top line results, H1 '29 because it's a 2-year treatment.

[Operator Instructions] The next question is from the line of Jim Sidoti with Sidoti & Company.

Your distribution business, the last 2 quarters has really shot up. I think it was 80% growth in the second quarter, 60% growth this quarter. I assume that's because of the addition of some of the new products to that business. Are these stocking orders? Or are these actual usage? Are these the kind of numbers we should expect going forward?

This is [indiscernible]. We have kind of a regional portfolio. We have launched additional new products over the last 12 months. in total market. So a very rich portfolio currently of distributed products. Biosimilars is just 1 of those products, as I mentioned on the call, it has a $2.5 million contribution this year. And we're going to launch 2 additional products over the next few weeks. So you should expect that this level of distribution business to continue and continue growing over the next few years.

All right. And with the plasma collection centers in Texas, I assume you're collecting some specialty plasma now. Can you just give us a sense how much you're collecting relative to what you acquire? Are you collecting the bulk of what you need now for your proprietary products? And when do you think that -- or if not now, when do you think it will be selecting enough plasma in Texas to supply your proprietary products?

So good question. We are ramping up the specialty over collection to collect the bulk of the collection now in Houston and San Antonio is still normal source plasma because when you open a new site, you first need to approve your normal source plasma collection before you can move into the specialty collection.

The specialty comes primarily from the Beaumont side, which was our first site and that's a site which is dedicated only to specialty plasma. So we are not yet at a point that majority of our needs come from our own collection, but we're still working with external suppliers, partners that we've been working for many years.

Over time, we will gradually increase our own self-collection which will allow us to become more and more kind of vertically integrated and self-sufficient in terms of specialty plasma. In any case, we don't expect to be fully independent. We'd like to have also kind of second and third suppliers for each one of the plasma types in order to have kind of a backup plan if needed as part of our risk management. So this is something which is going to grow over time and over the next few years.

Okay. And then last question for me. I know you've said you plan to release some interim data from the clinical trial for the AATD treatment sometime, I would assume, in December. How will you do that? Will it be a press release? We have a conference call? How are you going to let -- the Street know how that trial is going?

Yes. So just to maybe give a little bit more color around this futility analysis. So it will be conducted by end of the year. Results will be publicly shared through a press release. The analysis is being performed by an unblinded external using data available to date. We are analyzing probability of success of the study, efficacy end points based on a predefined success threshold. This is going to be a go-no-go futility analysis and results, as I mentioned, will be published through a PR before the end of this year.

At this time, I'll turn the floor to Brian Ritchie for any questions that come in from the web.

First question, so can you talk about the performance of CYTOGAM to date this year, Amir? And related to that, what are the significant growth drivers year-to-date in the business.

Yes. So as described in my presentation, we are generating significant profitable growth this year as a result of the diversity of the portfolio. So [indiscernible] is generated through multiple products, GLASSIA sales in Axis markets, mainly Latin America and the CIS countries where we focus on AATD disease awareness and diagnosis, and we are market leaders as well as growing sales of the product in Switzerland and Israel.

Advising at strong 3 quarters in the U.S. market, our medical and commercial teams are making significant successful efforts in increasing awareness of the importance of using arising during chicken pox outbreaks to treat immunocompromised population, which are at risks that were exposed to the chicken pox. And as I answered the previous question, the Israel distribution business is growing, and this include our platform-derived product, respiratory therapies and the biosimilars. And this, in addition to the [indiscernible], solid, strong sales, [indiscernible], especially in the U.S. market in the MENA region, GLASSIA Royalties from Takeda and CYTOGAM, specifically regarding CYTOGRAM.

So as I answered Annabel on the first question, to significantly expand the use of the product. There's a need for up-to-date medical and think information. And this was not available when we began marketing the product in late 2021. So we are working thoroughly to generate and later on to publish such medical data and collaboration with leading KOLs. And to this end, we've launched the extensive clinical program, including the SHIELD study which I described earlier.

The growth during this period during this clinical program will be gradual. Specifically this year, CYTOGAM calls been below our plan, partly due to inventory management in the channels, the time it takes to add the product to hospital formularies as well as fewer transplants performed during H1 in some of the hospitals or the product is used. We are addressing, we have addressed and we are addressing these issues and expect resumed growth during the next few months.

Thanks, Amir. With respect to GLASSIA royalties, now that those have declined to 6%, can you elaborate on where they'll go next year?

Yes. So as I think everyone knows, starting mid-August, meaning like 1.5 months into the third quarter we just ended, the royalties agreement with Takeda reached its second phase, which includes 6% royalties on the net market sales in the U.S. and Canada. This agreement is going to continue until 2040 meaning that we have a very long tail of additional 15 years of royalties, and we expect the royalties to be above $10 million in 2026 and continue to grow at single-digit rate annually thereafter.

Important to say that we are planning for this event. This is not a surprise for us. And as demonstrated in our Q3 results and Chaime mentioned it and our full year 2025 guidance, we have alternative revenues and profitability sources, and that results in a diversity of the portfolio and is compensating for the reduction of the royalties moving into 2026 and beyond.

Just an example -- one example, GLASSIA growth in the international markets, doubled between '23 and '24 and expect it to continue growing this year and beyond. And this is just one of the product in our portfolio. which allows us to compensate on the reduction of the royalties and to continue growing the business in a very profitable way.

Thanks, Amir. Final question. Maybe you can comment on your current BD activities and the similarly lengthy time line to execute a transaction?

Yes, of course. So as I mentioned during the call, we continue to conduct active due diligence activities over several potential commercial targets. We expect to secure such a transaction at the early stage of 2026. The time for execution a little bit longer than what we expected, but this is because we are basically doing a third due diligence, looking for the right transaction for Canada which will best fit our capabilities, commercial and operational synergies and available resources.

And I'm confident that similar to the transaction we've done in the past, would also be successful in selecting and integrating the right assets for Canada in the current phase of our EBITDA activities.

Thanks, Amir. I'll let you give your closing remarks now.

Okay. Thanks, Brian. So in closing, we continue to invest in our 4-pillar growth strategy with continued progress made in organic growth of our existing commercial portfolio, the business development and M&A transaction to support and expedite our growth, expansion of our plasma collection programs and progression of our AAT therapy program.

We look forward to continue to support clinicians and patients with important life-saving products that we develop [indiscernible] and commercialize. And we thank you all for your interest and support, and we remain committed to creating long-term shareholder value. We [indiscernible] all safe and healthy. Thank you very much.

Ladies and gentlemen, thank you for your participation. This concludes today's teleconference. You may now disconnect your lines, and have a wonderful day.

Greetings, and welcome to the Kamada Limited Second Quarter 2025 Earnings Conference Call. [Operator Instructions]. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Brian Ritchie, Managing Director of LifeSci Advisors. Thank you. You may begin.

Thank you. This is Brian Ritchie with LifeSci Advisors. Thank you all for participating in today's call. Joining me from Kamada are Amir London, Chief Executive Officer; and Chaime Orlev, Chief Financial Officer.

Earlier today, Kamada announced its financial results for the 3 months and 6 months ended June 30, 2025. If you have not received this news release, please go to the Investors page of the company's website at www.kamada.com.

Before we begin, I would like to caution that comments made during this conference call by management will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Kamada. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, the company's Forms 20-F and 6-K, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, Wednesday, August 13, 2025. Kamada undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.

With that said, it's my pleasure to turn the call over to Amir London, CEO. Amir?

Thank you, Brian. My thanks also to our investors and analysts for your interest in Kamada and for participating in today's call. I'm pleased to report that our results for the second quarter and the first half of 2025 was strong and that we continue to generate significant profitable growth. Total revenues for the first half of the year were $88.8 million, representing an 11% year-over-year increase and adjusted EBITDA for $22.5 million, up 35% year-over-year and representing a 25% margin of revenues.

For the second quarter, revenues were $44.8 million up 5% over the prior year quarter, and adjusted EBITDA was $10.9 million, up 20% year-over-year. These impressive results were driven by the diversity of our product portfolio and disciplined management of operational expenses. We expect to continue generating profitable growth through the remainder of 2025. And based on our positive outlook, we are increasing our adjusted EBITDA guidance to between $40 million to $44 million and reiterating our annual revenue guidance of $178 million to $182 million. The midpoint of our updated 2025 guidance represent increase of approximately 12% in revenues and approximately 23% in adjusted EBITDA respectively, over our last year 2024 results.

We're excited for growth prospects in our business, over both in near and longer term, guided by our four-pillar growth strategy of organic commercial growth business development and M&A transactions, our plasma collection operation and the advancement of our pivotal Phase III InnovAATe program.

As you may recall, last quarter, we announced the initiation of a comprehensive post-marketing research program for CYTOGAM which we believe will help demonstrate the advantages of the product in the prevention and management of CMV disease. Although CMV disease continues to be a significant risk factor for organ rejection and mortality in transplantation. For years, no new up-to-date clinical data regarding the benefit of CYTOGAM was published. To address this, we developed this program in collaboration with key opinion leaders [indiscernible] still advancement of novel CMV disease management. The research studies supported by this program will focus on late onset CMV prevention and mitigation of active CMV disease, exploring alternative dosing strategies and investigating potential new applications of CYTOGAM. We believe that the data generated by this program will support further product utilization for CYTOGAM, leading to additional organic growth.

Our revenue growth for the first half of the year compared to the first 6 months of 2024 was primarily due to increased sales of GLASSIA in ex U.S. market and VARIZIG sales in the U.S. as well as GLASSIA royalty payments. This positive trend indicative of the diversity of our portfolio and our successful marketing activities action territories and medical specialties. Also as part of our activities to advance organic growth, filling our first biosimilar product launch in Israel last year, which is expected to generate approximately $2.5 million in revenues in 2025. We anticipate launching 2 additional biosimilars later this year and have several others in the pipeline to be launched in the coming years.

The [indiscernible] portfolio will become an increasingly important portion of our distribution business with annual sales of between $15 million, $20 million within the next 5 years.

Moving to business development and M&A. We are currently conducting active due diligence of several potential commercial targets during the balance of 2025 and into 2026. We expect to secure compelling in-licensing, collaboration and/or M&A transactions, which will enrich our portfolio of marketed products and complement our existing commercial operations. We anticipate that such transactions will generate operational and/or commercial synergies with our current commercial portfolio and support future profitable growth. In addition, we continue to ramp up plasma collection at our 3 Texas-based Plasma Centers, and we're happy to announce earlier this week the U.S. FDA approval of a state-of-the-art center in Houston, Texas. We're especially appreciative of the work of a dedicated team of plasma collection experts who achieved inspection and licensure of its facility on schedule.

As previously stated, this center has annual collection capacity of approximately 50,000 liters of plasma and each of our 2 centers in Houston and New San Antonio is expected to generate annual revenues of between $8 million to $10 million in sales of normal source plasma at full capacity.

Turning now to our ongoing pivotal Phase III InnovAATe clinical trial for inhaled Alpha-1 antitrypsin therapy. We continue to advance this program with its revised enrollment goal of approximately 180 subjects, and we are on track to conduct an interim futility analysis by the end of the year 2025.

With that, I turn the call over to Chaime for a detailed discussion of our financial results for the second quarter of 2025 and first 6 months of the year. Please go ahead, Chaime. Thank you.

Thank you, Amir. As Amir stated at the top of the call, our results for the second quarter and 6 months ended June 30, 2025, were strong. Total revenues were $44.8 million in the first quarter of 2025, up 5% compared to the $42.5 million in the second quarter of 2024. Revenues for the 6 months of 2025 were $88.8 million, an 11% increase from the $80.2 million generated in the first 6 months of 2024.

As Amir indicated earlier, the increase in revenue was driven by the diversity of the company's portfolio. Gross profit and gross margins were $18.9 million and 42% in the second quarter of 2025 compared to $19 million and 45% in the second quarter of 2024. Gross profit and gross margins for the first 6 months of 2025 were $39.7 million and 45% compared to $35.7 million and 45% in the first half of 2024. The decrease in gross profitability in the second quarter of 2025 is attributable to change in product and territory sales mix, whereas during this quarter, the increase in revenue was generated by ex-U.S. sales as compared to sales mix in the equivalent quarter last year.

Operating expenses, including R&D sales and marketing and G&A and other expenses totaled $11.9 million in the second quarter of 2025 as compared to $13.3 million in the second quarter of 2024. The decrease in operating expenses, which was also demonstrated in the first quarter of the year, is indicative of our ability to adequately manage our operational expenditures while continuing to generate meaningful revenue growth.

Net income was $7.4 million or $0.13 per diluted share in the second quarter of 2025 as compared to $4.4 million or $0.08 per diluted share in the second quarter of '24. Net income for the 6 months of 2025 was $11.3 million or $0.19 per diluted share as compared to net income of [ $0.8 ] million [indiscernible] per diluted share in the first 6 months of '24. The increase in net income is attributable to increase in operating profits, which increased by [ 4% ] for the first half of the year and 25% for the second quarter as well as changes in the financial and tax expenses between the periods.

Adjusted EBITDA was $10.9 million in the second quarter of 2025, up 20% and from the $9.1 million achieved in the second quarter of '24. Adjusted EBITDA was $22.5 million in the first 6 months of 2025, a 35% increase compared to the $16.6 million for the first 6 months of '24. As Amir indicated, we're increasing our adjusted EBITDA guidance for the year to between $40 million and $44 million.

Cash provided by operating activities was $8 million in the second quarter of 2025. And we continue to maintain a strong cash position even after the special dividend payment. And we ended the first half with a cash balance of $66 million that is planned to be used to fund new business development initiatives.

Before turning the call over to questions, I would like to indicate that we are continuing to monitor the evolving tariff situation closely. Based on presently available information, our assessment is the recently imposed tariffs are not applicable to drug products. To date, we have not experienced impact or interruptions of our operations or ability to maintain cost and pricing as a result of the tariffs. With that, we will open the call to questions.

[Operator Instructions] The first question is from Annabel Samimy from Stifel.

So just a couple for me. It seems like for the last 2 quarters, GLASSIA and VARIZIG have been the growth drivers, I guess, for reasons you've stated, especially VARIZIG. But can you give us an idea about dynamics behind KEDRAB and CYTOGAM, which, I guess, had been the growth drivers? Is it more difficult year-over-year comps? Are they performing as expected? Or maybe are physicians just slowing down on adoption of CYTOGAM until the next batch of data? Just any color there would be great. And then I'll just follow up after that.

Yes, we mentioned specifically GLASSIA, ex-U.S in royalties and VARIZIG because these are the products which had a significant contribution to our year-over-year growth. KEDRAB and CYTOGAM are performing according to our expectations. As you know, the KEDRAB contract with Kedrion is like a 4 year, it's an 8 year with the 4-year committed volumes. Kedrion buy the product, we supply them according to the inventory management. We continue to see in market growth, but in general, the numbers of sale to 2024 numbers.

CYTOGAM is going according to the plan. We expect that the growth come once we have the additional clinical and medical data, which we are currently connecting. But I think in general, it's an opportunity to emphasize the strength and the diversity of the portfolio. We [indiscernible] approved products marketing over 35 countries, over 25 products in our distribution business, the soon-to-be plasma sales. We have a very strong organic growth that's coming from multiple products. And this year, it's been mainly GLASSIA and VARIZIG, previous years, it's been CYTOGRAM and KEDRAB. But all in all, it's a very strong, diverse portfolio that allows us to continue maintaining the growth year after year.

Yes, definitely noted. And then you have a solid cash position for a profitable company. But is it sufficient for impactful BD? Given it's declined in the last couple of quarters. How should we think about the balance of your internal investments that you're obviously making quite a few and then the external BD and how that might be funded?

So we plan to utilize to use our cash. If needed, we have additional sources for this funding in multiple [indiscernible] funding that we can put to work. We are looking and screening for commercial stage assets. I think the fact that we're looking for commercial stage it gives us a lot of bandwidth in terms of the ability to fund those transactions. We are mainly focused on plasma-derived products as well as specialty pharma and within the specialty pharma, the transportation field.

And as I mentioned during the call, we would like to leverage our supply chain ability, commercial infrastructure, take advantage of the synergies, and we are actively screening and doing due diligence on some multiple targets, and hopeful that it will be mature over the next few months into 2026 and have a meaningful impact on our 2026 profits. Funding to the [indiscernible] of the transaction we're looking to do, we will have sufficient funding to execute [indiscernible].

Okay. If I could just squeeze in one more on the Inhaled AAT program. Obviously, we're just waiting for the interim analysis right now. But can you sort of describe the competitive landscape there have been, I guess, some more developments whether gene therapy or other programs, anything that we should be watching for that might change the potential market opportunity there?

Yes. Good question. So yes, there is a lot of activity in the Alpha-1 space in general. Our Inhaled program is the more advanced in terms of an efficacy study in a pivotal stage. So there's no other Phase III pivotal studies that are structured around efficacy endpoint. We are making progress. There are other companies also making progress. I think you and other people following this space know that there are maybe 2 or 3 additional technologies which are currently being developed. The market is growing, growing with the growth of our royalties from [ Takeda ]. So the 6%, 7%, 8% annual growth is actually happening. What is a $0.5 billion market is like $1.3 billion, $1.4 billion market. We believe that by the time that we are going to have the result on a study, this is going to be like a $1 trillion market. So we believe that there is enough business and enough opportunity for multiple new technologies, multiple new players.

We believe that our technology being like a second-generation augmentation therapy with [indiscernible] of use and quality of life, with, hopefully, if we have success on the study, efficacy data will be a very strong competitor and player in the Alpha-1 space in general.

[Operator Instructions] The next question is from James Sidoti from Sidoti & Company.

So as you said, the quarter really demonstrated how diverse your different revenue streams are. The one that grew this quarter in particular was the distributed revenue segment, I guess, with the launch of the new product, the biosimilar products. Was there a onetime sales in the quarter? Or how should we view this distribution channel going forward?

Thank James. No, this is not onetime sales. The launch of the biosimilar product and the future launches, we expect two more by the end of this year, is going to build on an existing infrastructure of our commercial activity in the Israeli market. And this is something that we will continue growing.

You all said that we had a better margin this quarter the more we launch biosimilars and based on our innovative portfolio [indiscernible] will help us also improve our margins. So this is a process that has started and will continue over the next year.

Okay. So there was no stocking or changing in the quarter. These were -- you think these types of numbers you think will be going forward?

Correct.

Okay. And then a similar question on the SG&A expense. I mean, down pretty significantly from year -- down significantly year-over-year. Were there onetime things there that help that? Or do you think you'll stay around these levels?

So we are very conscious about our expenses. I think we've been very disciplined in the way that we deploy investment and ongoing expenses. There's been a slight say, kind of fluctuation between quarters and between the first 6 months of the year and the second 6 months of the year, the second 6 month of the year might be a little bit higher, again, insignificant, a little bit higher in general. But I think what's very highly promising, and I think all analysts and investor need to look at this, our ability to generate a good and improved rate of EBITDA from top line.

And we said in the past that when we were on the 20% EBITDA of top line that we are targeting 25% and above. I think we've been able to demonstrate this over the last few quarters, and this is our goal to continue to be profitable. And from every dollar we make that we will have a bigger portion all the way to the bottom line EBITDA.

Okay. And then last question for me, something I asked 3 months ago, you said the tax rate would continue to be a little bit lumpy in 2025. What was responsible for the tax credit in the June quarter? And where do you think the tax rate will be in September and December?

I'll refer this question to Chaime.

I'll take this question. So we anticipate the Israeli entity or the parent company is reporting in Israeli shekels. Over the course of the last quarter, there's been fluctuations in the currency exchange between the shekel Israeli and U.S. dollars that affected our results for tax purposes and made the change. Overall, we still of the opinion that -- by the end of 2025, the company will be utilizing all of its tax losses carryforward, and we will be moving into tax payments. Right now, the changes that you see are mostly in deferred tax, either assets or liabilities, which are causing the bumpiness as you alluded to.

Okay. So when those NOLs are used up as you look into 2026 and beyond, what do you think will be an effective tax rate?

Well, we're looking at anywhere between 20% or 25%.

There are no further questions at this time. I would like to turn the floor back over to Amir London for closing comments.

Thank you very much. In closing, we continue to invest in the four-pillar growth strategy with continued progress made in organic growth of our existing commercial portfolio, business development and M&A transaction to support and expedite our growth, expansion of our Plasma Collection operation and the progression of our ATT therapy program. We look forward to continuing to support clinicians and patients with this dose important life-saving products that we develop, manufacture and commercialize. We thank you all for your interest in Kamada and we are committed to creating long-term shareholder value. We hope you all stay happy and safe. Thank you for participating in today's call.

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.