3/11/2026

speaker
Operator
Conference Operator

Greetings and welcome to the Commodore Limited fourth quarter 2025 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the call, please press star zero on your telephone keypad. 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.

speaker
Brian Ritchie
Managing Director, LifeSci Advisors

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 Jaime Orlev, Chief Financial Officer. Earlier today, Kamada announced its financial results for the three months and year ended December 31st, 2025. If you have not received this news release please go to the investors page of the company's website at www.camada.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 Camada. I encourage you to review the company's filings with the Securities and Exchange Commission, including Without limitation, the company's forms 20F and 6K, 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. 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?

speaker
Amir London
Chief Executive Officer

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, Commodity 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 committee management are pleased to declare a dividend of 25 cents per share, totaling approximately $14.4 million, payable on April 6th to shareholders of record as of March 23rd. 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 to the section of the dividend distribution test under the Israeli company's 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 from a position of significant strength, continuing to benefit from growth across our entire portfolio. Based on a positive outlook and consistent performance, we affirmed our 2026 annual guidance of $200 million to $205 million in revenues and $50 million to $53 million of adjusted EBITDA, which respectively represents 13% and 23% growth when comparing 2026 guidance midpoints 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 lifecycle management of our six 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 Israel markets, as well as 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 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-rabbit immoglobulin, Kedrub, which is being distributed in the U.S. through our collaboration with Kedrion. Sales of the product to Cadrion increased in 2025 to approximately $54 million, well above the contract minimum commitment. We have a firm commitment of $90 million from Cadrion for minimum orders from 2026 through 2027, and our current supply agreement with them runs through 2031. In addition to a significant market share in the U.S., we continue to grow sales of CamRub in leading international markets such as Canada, Latin American countries, and Israel. Glacia represents our second leading franchise with total revenue contribution of $35 million split between our growing product sales in ex-US markets and royalty income generated from sell of the product by Takeda in the US and Canada. Moving on to our anti-CMV immunoglobulin, CytoGAM. Revenues from the product declined during 2025. We believe the decline was primarily due to increased usage of antivirals such as latrimavir and maribivir, resulting from improvements in their market access coverage. As you may recall, in 2025, 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 benefits 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 Help 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 benefits 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 worse transplant recipient health and outcome. The study is being conducted by leading expert in CMV and organ transplantation, Dr. Camille Coton, infectious disease specialist and clinical director of transplant and immune-compromised host infection disease at Massachusetts General Hospital, and Dr. David was on Winski, Medical Director of the Kidney Transportation Program at the University of Texas Southwestern Medical Center. We are very pleased to 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 cytogen. Also, as part of our activities to advance organic growth, Following the first two biosimilar product launches in Israel during 2024 and 2025, we will be launching in Israel two 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 four to five 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 at 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 two 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 in the first half of 2026. As previously stated, each of those two 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&As. We are currently pursuing new opportunities, and we are hopeful that we will be able to secure compelling in-licensing, collaboration, and all 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 now turn the call over to Jaime for a detailed discussion of our financial results for 2025. Jaime, please go ahead.

speaker
Jaime Orlev
Chief Financial Officer

Thank you, Amir. As Amir stated at the top of the call, we reported strong results for the year ended December 31st, 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 Vareseg and Kedra in the U.S. market, Camarab and Glacia 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 to $14 million extension of an existing tender from the Canadian Blood Services for the supply of Winro, Hepagram, Cytogram, and Varazig for an additional two 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. Operating expenses, including R&D, sales and marketing, G&A, and other expenses total $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 EB down 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 31st, 2025, Kamena had cash and cash equivalents of 75.5 million as compared to 78.4 million in December 2020. 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 31st, 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 and 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.

speaker
Operator
Conference Operator

We will now open the call for questions.

speaker
Operator
Conference Operator

Thank you. If you'd like to ask a question, please press star 1 on your telephone keypad A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. Our first question comes from the line of Annabelle Samimi with Stifel. Please proceed with your question.

speaker
Annabelle Samimi
Analyst, Stifel

Hi, everyone, and thanks for taking my question. Great end to the year. I want to ask a few questions. I guess the first one I want to ask about the CMV market and whether you mentioned that the reduction cytogamm was due to increased access of antivirals. Is there any change in the protocols for CMV or is there any improvement in the actual efficacy of CMV? 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?

speaker
Amir London
Chief Executive Officer

Hi, Annabel. We are not aware of any change in the protocol of CMV management. We do know and we did follow some of the antivirals providers announcement that they had a strong 2025 as a result of better market access. We believe that there might be some insurers that have not covered, you know, the antivirus in the past, and now they are covering it, and this might have some effect on cytogram usage during 2025. Having said that, I would like to emphasize that we still have strongly believe in the need for Cytogram 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 Cytogram and the advantages to administrate Cytogram in addition to the antivirals kind of doubling the protection against CMV infection. With that regard, I'd like also to mention that while cytogram usage during recent years was primarily for 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 cytogram usage.

speaker
Annabelle Samimi
Analyst, Stifel

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 in the potential opportunities that you have for M&A or business development, or am I wrong to think that?

speaker
Amir London
Chief Executive Officer

No, you're absolutely correct. The dividend payment reinforces 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 dividends. 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.

speaker
Annabelle Samimi
Analyst, Stifel

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? 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?

speaker
Amir London
Chief Executive Officer

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

speaker
Operator
Conference Operator

Okay, perfect. Thank you. You're welcome.

speaker
Operator
Conference Operator

Thank you. Once again, to join the question queue, please press star 1 on your telephone keypad. Our next question comes from the line of Jim Sidoti with Sidoti & Company. Please proceed with your question.

speaker
Jim Sidoti
Analyst, Sidoti & Company

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

speaker
Amir London
Chief Executive Officer

We're at around between 30% to 40% ramped up. Right now, we believe it will be at full ramp by end of 2027. But, of course, during that period, we'll also start selling products normal source plasma to external parties and use our own specialty plasma for our own use.

speaker
Jim Sidoti
Analyst, Sidoti & Company

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

speaker
Amir London
Chief Executive Officer

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

speaker
Jim Sidoti
Analyst, Sidoti & Company

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

speaker
Amir London
Chief Executive Officer

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

speaker
Jim Sidoti
Analyst, Sidoti & Company

All right. And then, you know, 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.

speaker
Amir London
Chief Executive Officer

Including in the U.S. We expected this across our entire portfolio and entire kind of geographies. Okay.

speaker
Jim Sidoti
Analyst, Sidoti & Company

Oh, and one last one. The dividend, will that be the 25 cents, the entire 25 cents be paid out in the first quarter, or will that be spread out over the year?

speaker
Operator
Conference Operator

One moment, please. We're experiencing some technical difficulties. One second. Mr. Orlov, you're now connected again. Yes, I saw you.

speaker
Jim Sidoti
Analyst, Sidoti & Company

Okay, yeah, no, I was just asking on the dividend. Will the entire $14 million, will that be paid out in Q1? Yes, I saw you.

speaker
Operator
Conference Operator

Yes, I saw you. Yes, I saw you. Yes, I saw you. Let me try and reconnect in one moment. Mr. London, please go ahead. Yes, I apologize. We got disconnected.

speaker
Amir London
Chief Executive Officer

Jim, can you hear me? Yes, I can. Yeah, so can you repeat your question, please?

speaker
Jim Sidoti
Analyst, Sidoti & Company

Yeah, 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?

speaker
Amir London
Chief Executive Officer

Everything will be paid one time in the second quarter.

speaker
Jim Sidoti
Analyst, Sidoti & Company

Got it. All right, thank you.

speaker
Operator
Conference Operator

Again, I apologize for this being disconnected.

speaker
Operator
Conference Operator

Thank you. I'll turn the floor back to Mr. Johnson.

speaker
Jim Sidoti
Analyst, Sidoti & Company

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

speaker
Amir London
Chief Executive Officer

Yes, so we're very happy with Virizig performance in 2025. We've seen a significant increase. We believe that the declining 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 Virizig with immunocompromised population that have been exposed to those outbreaks, had a significant contribution to the increase in Varizig cells. 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.

speaker
Operator
Conference Operator

and XUX markets. Thank you, Amir.

speaker
Jim Sidoti
Analyst, Sidoti & Company

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

speaker
Operator
Conference Operator

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

speaker
Amir London
Chief Executive Officer

Thank you very much. So in closing, we continue to invest in the four-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 transactions to support and expedite our growth. We look forward to continuing to support clinicians and patients with important life-saving products that we develop, manufacture, and commercialize. We thank you all for your support and remain committed to creating long-term shareholders of value. Thank you very much. We hope you all stay healthy and safe.

speaker
Operator
Conference Operator

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

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-