Kamada Q3 2025 Earnings Report

Kamada EPS Results

• Actual EPS: $0.09
• Consensus EPS: $0.10
• Beat/Miss: Missed by -$0.01
• One Year Ago EPS: N/A

Kamada Revenue Results

• Actual Revenue: $47.01 million
• Expected Revenue: $154.21 million
• Beat/Miss: Missed by -$107.20 million
• YoY Revenue Growth: N/A

Kamada Announcement Details

• Quarter: Q3 2025
• Date: 11/10/2025
• Time: Before Market Opens
• Conference Call Date: Monday, November 10, 2025
• Conference Call Time: 8:30AM ET

Kamada (NASDAQ:KMDA) is a biopharmaceutical company headquartered in Israel that specializes in the development, manufacturing and commercialization of plasma‐derived protein therapeutics. The company focuses on treatments for rare and serious diseases, leveraging its proprietary fractionation and purification technologies to produce purified human proteins. Kamada’s product portfolio addresses critical therapeutic areas in immunology, hematology and pulmonology, where alternative treatment options may be limited.

Among Kamada’s marketed products is Glassia®, an alpha‐1 antitrypsin augmentation therapy approved by the U.S. Food and Drug Administration for patients with alpha‐1 antitrypsin deficiency who have emphysema. In addition, Kamada holds commercial rights to KEDRAB®, a rabies immune globulin product used for post‐exposure prophylaxis, and has distributed plasma‐derived factor IX concentrate (marketed under various brands) for patients with hemophilia B. These products are manufactured at Kamada’s vertically integrated facilities in Israel, and are sold through its U.S. subsidiary and distributors across North America, Europe and other international markets.

Building on its established product base, Kamada maintains a development pipeline that includes hyperimmune therapies and monoclonal antibody candidates, such as investigational treatments for COVID‐19. The company has collaborated with academic and industry partners to advance preclinical and clinical studies of novel plasma‐derived and recombinant proteins, aiming to expand its reach into additional rare disease indications and emerging infectious diseases.

Founded in 1990, Kamada has grown into a global specialty biopharma organization while retaining a strong connection to its Israeli roots. Ronen Zohar, who has served as Chief Executive Officer since 2011, leads a management team experienced in regulatory affairs, manufacturing scale-up and strategic partnerships. Through ongoing investments in research, production capacity and international marketing, Kamada seeks to enhance patient access to its therapies and pursue new opportunities in the plasma‐derived protein market.

Kamada Q3 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Reported strong Q3 and nine‑month 2025 results with total YTD revenues of $135.8M (up 11%), adjusted EBITDA of $34.2M (up 35%) and management reiterated 2025 guidance of $178M–$182M revenue and $40M–$44M adjusted EBITDA.
• Positive Sentiment: Revenue diversification drove growth—higher ex‑US Glassia sales, stronger Varizig performance, and a rapidly expanding Israeli distribution/biosimilars business (first biosimilar ~$2.5M in 2025 with two launches imminent) underpin continued commercial momentum.
• Negative Sentiment: Glassia royalties in the US/Canada stepped down to 6% in mid‑August, reducing future royalty cashflows even though management forecasts royalties >$10M in 2026 and a long tail through 2040.
• Positive Sentiment: Plasma collection expansion progressed: the Houston center received FDA approval, San Antonio approval is expected in early 2026, and each site is projected to generate ~$8–10M of normal‑source plasma revenue at peak capacity.
• Neutral Sentiment: The pivotal inhaled AAT (Innovate) trial faces enrollment challenges (currently ~60–65% of the ~180‑subject target); an interim futility analysis will be announced by year‑end, with full enrollment expected early 2027 and topline results in H1 2029, making this a material but distant binary catalyst.

Presentation

[Operator]

Good morning. Welcome to Kamada Ltd Third Quarter 2025 Earnings Conference Call. At this time, all participants are in listen-only mode. A question-and-answer session will follow the formal presentation. If anyone today should require operator assistance, please press star zero from your telephone keypad. Please note that 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.

[Brian Ritchie, Managing Director at LifeSci Advisors]

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 three months and nine months ended September 30th, 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.

[Brian Ritchie, Managing Director at LifeSci Advisors]

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 10th, 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 is my pleasure to turn the call over to Amir London, CEO. Amir?

[Amir London, CEO at Kamada]

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

[Amir London, CEO at Kamada]

We are excited for the growth prospects in our business over both the near and longer term, guided by our four-pillar growth strategy including organic commercial growth, business development and M&A transactions, our plasma collection operation, and the advancement of our pivotal phase III Inhaled AAT program. Our lead product continues to be our anti-rabies immunoglobulin KamRab, 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.

[Amir London, CEO at Kamada]

Revenue growth for the first nine months of the year, compared with the first nine 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.

[Amir London, CEO at Kamada]

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 explore advancements 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 Immunoglobulin to Enhance Protection Against Late CMV Disease, or SHIELD, 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 administered 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.

[Amir London, CEO at Kamada]

Those patients are at the highest risk of developing late-onset CMV infection, which is associated with worse transplant recipient health and outcomes. We are very pleased to be working with notable experts in this field, and we believe that the data generated by this study and others planned for this program will support increased product utilization for Cytogam, 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 two 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-$20 million within the next five years.

[Amir London, CEO at Kamada]

Moving to business development and M&As, we continue to conduct active due diligence over several potential commercial targets. During the 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 anticipate that 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. Both facilities support 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.. 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.

[Amir London, CEO at Kamada]

We intend to seek subsequent inspection and approvals from the European Medicines Agency, the EMA, of both sites. We are currently engaged in discussion with potential customers to secure long-term sales agreements for normal source plasma. As previously stated, each of those two centers is expected to generate annual revenues of $8 million-$10 million in sales of normal source plasma at full capacity. Turning now to our ongoing pivotal phase III Innovate 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 announce its results by the end of this quarter. With that, I now turn the call over to Chaime for a detailed discussion of our financial results for the third quarter and nine months of 2025. Chaime, please go ahead.

[Chaime Orlev, CFO at Kamada]

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

[Chaime Orlev, CFO at Kamada]

It is important to note that we continue to achieve double-digit growth even through the expected decline in GLASSIA 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 2025, compared to $17.2 million and 41% in the third quarter of 2024. For the first nine months of 2025, gross profits were $59.4 million and 44%, compared to $52.9 million and 43% in the first nine 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.

[Chaime Orlev, CFO at Kamada]

Operating expenses totaled $36.8 million in the first nine months of 2025, as compared to $38 million in the first nine 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 nine months of 2025 was $16.6 million, or $0.29 per diluted share, up 56% compared to the first nine 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 nine months of 2025, adjusted EBITDA was $34.2 million, a 35% increase compared to the first nine months of 2024.

[Chaime Orlev, CFO at Kamada]

It should also be noted that the adjusted EBITDA for the first nine months of 2025 was equal to that reported for the full year of 2024. For the first nine 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]

Thank you. We'll now be conducting a question-and-answer session. If you'd like to ask a question at this time, you may press star one from your telephone keypad and the confirmation tone to indicate your line is in the question queue. You may press star two if you'd like to withdraw your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Once again, that is star one. Thank you. Thank you. Our first question comes from the line of Annabel Samimy with Stifel. Please proceed with your question.

[Annabel Samimy, Managing Director at Stifel]

Hi, all. Thanks for taking my question. 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 you've been using for clinical education so far, what this adds to the package. 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?

[Amir London, CEO at Kamada]

Hi, Annabel. Thank you for the question. The main difference between the current treatment population of Cytogam and this SHIELD study is that currently, Cytogam is primarily used either prophylactically at the time of the transplantation as part, especially for high-risk patients, which are donor-positive, recipient-negative, or as part of treatment if there is actual active disease of patients a few days or weeks into the post-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 antivirals, at that point, the physician starts trimming down the antiviral usage, and that's a risk for a flare of CMV disease for the patient. This is basically kind of prophylactic usage at late stage after transplantation as part of trimming down the antiviral usage. What percentage? I don't remember top of my head.

[Amir London, CEO at Kamada]

I would like to say around 20%, but I will check this and get back to you.

[Annabel Samimy, Managing Director at Stifel]

Okay. Great. That was helpful color. I guess I'm also curious about AATD, 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. How is that impacting your enrollment? Are you still—I mean, I know you're on target for the interim study or interim analysis. How is the enrollment completion timeline looking and top-line data?

[Amir London, CEO at Kamada]

Okay. Good. Enrollment is continuing. As you say, that's an orphan disease. Because we are studied with a placebo arm, 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, where active sites have highly committed to the inhaled study. As you said, we will have the futility analysis results before the end of the year. We expect those results, if they are positive 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 2027, which means top-line results H1 2029 because it's a two-year treatment.

[Annabel Samimy, Managing Director at Stifel]

Okay. All right. Thanks. That's helpful. All right. I'll get back into the queue. Thank you.

[Amir London, CEO at Kamada]

Thanks.

[Operator]

As a reminder, if you'd like to ask a question at this time, you may press star one. The next question is from the line of Jim Sidoti of Sidoti & Company. Please proceed with your question.

[Jim Sidoti, Analyst at Sidoti & Company]

Hi. Good afternoon. Thanks for taking the questions. Your distribution business, the last two 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?

[Amir London, CEO at Kamada]

This is actual usage. We have kind of a richer portfolio. We have launched additional few products over the last 12 months into the Israeli market. We have a very rich portfolio currently of distributed products. Biosimilars is just one of those products, as I mentioned on the call. It has a $2.5 million contribution this year. We are going to launch two additional products over the next few weeks. You should expect this level of distribution business to continue and continue growing over the next few years.

[Jim Sidoti, Analyst at Sidoti & Company]

All right. With the plasma collection centers in Texas, I assume you're collecting some specialty plasma now. Can you just give us a sense of how much you're collecting relative to what you require? Are you collecting the bulk of what you need now for your proprietary products? If not now, when do you think you will be collecting enough plasma in Texas to supply your proprietary products?

[Amir London, CEO at Kamada]

Good question. We are ramping up the specialty plasma collection. 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 site, which was our first site. That is a site which is dedicated only to specialty plasma. We are not yet at the point that the majority of our needs come from our own collection, but we are still working with external suppliers, partners that we have been working with 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.

[Amir London, CEO at Kamada]

In any case, we don't expect to be fully independent. We would 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. This is something which is going to grow over time and over the next few years.

[Jim Sidoti, Analyst at Sidoti & Company]

Okay. And then last question from me. I know you 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? Will you have a conference call? How are you going to let the street know how that trial's going?

[Amir London, CEO at Kamada]

Yeah. Just to maybe give a little bit more color around this fertility analysis. It will be conducted by the end of the year. Results will be publicly shared through a press release. The analysis is being performed by an unblinded external DSMB using data available to date. We're analyzing probability of success of the study, efficacy endpoints based on a predefined success threshold. This is going to be a go, no-go fertility analysis. The results, as I mentioned, will be published through a PR before the end of this year.

[Jim Sidoti, Analyst at Sidoti & Company]

All right. Thank you.

[Operator]

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

[Brian Ritchie, Managing Director at LifeSci Advisors]

Thank you. First question. Can you talk about the performance of Cytogam to date this year, Amir? Related to that, what are the significant growth drivers year to date in the business?

[Amir London, CEO at Kamada]

Yes. As described in my presentation, we are generating significant profitable growth this year as a result of the diversity of the portfolio. Growth is generated through multiple products, GLASSIA in ex-U.S. 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. VARIZIG had a strong three-quarters in the U.S. market. Our medical and commercial teams are making significant successful efforts in increasing awareness of the importance of using VARIZIG during chickenpox outbreaks to treat immunocompromised populations, which are at risk, that were exposed to the chickenpox. As I answered the previous question, the Israeli distribution business is growing, and this includes our plasma-derived products, respiratory therapies, and the biosimilars.

[Amir London, CEO at Kamada]

This is in addition to the KamRab, solid, strong sales, HepaGam and WinRho, especially in the U.S. market and the MENA region, GLASSIA royalties from Takeda and Cytogam. Specifically regarding Cytogam, as I answered Annabel on the first question, to significantly expand the use of the product, there is a need for up-to-date medical and clinical information. This was not available when we began marketing the product in late 2021. We are working thoroughly to generate and later on to publish such medical data in collaboration with leading KOLs. To this end, we have 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.

[Amir London, CEO at Kamada]

Specifically, this year, Cytogam sales have been below our plan, partially 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 where 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.

[Brian Ritchie, Managing Director at LifeSci Advisors]

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

[Amir London, CEO at Kamada]

Yes. So as I think everyone knows, starting mid-August, meaning like 1.5 months into the third quarter, which just ended, the royalties agreement with Takeda reached its second phase, which includes 6% royalties on their 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's resulting from the diversity of the portfolio.

[Amir London, CEO at Kamada]

This is compensating for the reduction of the royalties moving into 2026 and beyond. Just as an example, one example, GLASSIA growth in the international markets doubled between 2023 and 2024 and is expected to continue growing this year and beyond. This is just one of the products 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.

[Brian Ritchie, Managing Director at LifeSci Advisors]

Thanks, Amir. Final question. Maybe you can comment on your current BD activities and the seemingly lengthy timeline to execute a transaction.

[Amir London, CEO at Kamada]

Yes, of course. As I mentioned during the call, we continue to conduct active due diligence activities over several potential commercial targets. We expect to secure such transactions at the early stage of 2026. The timelines for execution are 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 Kamada, which will best fit our capabilities, commercial and operational synergies, and available resources. I'm confident that, similar to the transaction we've done in the past, we'd also be successful in selecting and integrating the right assets for Kamada in the current phase of our BD activities.

[Brian Ritchie, Managing Director at LifeSci Advisors]

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

[dupeAmir London, CEO at Kamada]

Okay. Thanks, Brian. In closing, we continue to invest in our four-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 continuing to support clinicians and patients with important lifesaving products that we develop, manufacture, and commercialize. We thank you all for your interest and support, and we remain committed to creating long-term shareholder value. We all hope you all stay safe and healthy. Thank you very much.

[Operator]

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

Participants

Executives

• Amir London, CEO
• dupeAmir London, CEO
• Chaime Orlev, CFO

Analysts

• Annabel Samimy, Managing Director at Stifel
• Jim Sidoti, Analyst at Sidoti & Company
• Brian Ritchie, Managing Director at LifeSci Advisors