Q3 2025 Kamada Ltd Earnings Call
Good morning.
Welcome to Commodities limited commodity limited third quarter, 2025 earnings conference call.
This time all participants are in listen. Only mode.
A question answer session will follow the formal presentation.
If anyone today needs car 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 Richie with life side, advisors. Thank you. Brian. You may now begin.
Thank you. This is Brian Richie with lifeside boxers. Thank you. All for participating in today's call.
Joining me from kamada are Amir London.
Chief Executive Officer, Amir London, and Chief Financial Officer, Chaime Orlev.
Earlier today, kamada announced his financial results for the 3 months and 9 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.moda.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 6K, which identify specific factors that may cause actual results or events to different materially from those described in the forward-looking statements,
Furthermore.
Sensitive information. That is accurate only, as of the date of the live broadcast Monday, November 10th, 2025
Comma undertakes, no obligation to revise or update, any statements to reflect events or circumstances after the date of this conference call. With that said is my pleasure to turn the call over to Amir London, CEO Amir
Thank you, Brian. And thanks also to our investors and analysts for your interest in kommoda and for participating in today's call.
I'm pleased to report that our resource for the third quarter and first 9 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.
In adjusted ebida 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, and based on our positive outlook, we are reiterating our annual revenue guidance of $178 million to $282 million and adjusted EBITDA guidance of between $40 million and $444 million, representing double-digit growth.
Over our 2024 results.
We are excited for the growth Prospect. In our business, over both a near and longer term Guided by our 4. Pillar growth strategy, including organic commercial growth with the development and m&a transactions for plasma collection operation. And the advancement of our pivotal phase 3 in held aat program.
Our lead product continues to be our anti-rabbit in the global Lan-K drop, which is being distributed in the U.S. through our collaboration with Cadion. From this partnership, we have assumed a commitment to minimum orders for 2025 to 2027, and the supply agreement with them further extends to 2031.
In addition to a 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 to the first 9 months of 2024 was primarily achievable to the increased sales of glassia. Our aat IV product, in xus markets, many Latin America. And the CIS region in addition to our sales in those countries. The products continues to generate royalty income on sales by picada in the US and can
In markets.
Our ability to generate significant profitable growth is indicative of the diversity of our portfolio. There are successful marketing activities across different territories and Medical Specialties.
Moving on to our anti CMV, imuglo Saito gum.
As you may recall earlier this year, we announced initiation of a comprehensive, post-marketing research program for Saito gum, which we believe will help demonstrate the advantages of the product, is the prevention and management of the CMV disease.
Although CMV continues to be a significant risk factor for organ rejection and mortality in transplantation, no new, up-to-date clinical data regarding the benefit of Saito gum have been published.
To address this. We developed this program in collaboration with leading key opinion leaders to explore advancement of Novel, CMV disease management.
In October, we announced the enrollment of the first patient in an investigator initial trial included in his program.
The trial called strategic Health with hemoglobin to enhance protection against late CMV disease, or Shields is a protect, is a prospective randomized, control. Multicenter investigation, study in CMV, high-risk kidney transplant, recipients,
The Shield study will investigate the benefits.
Of Saito. Administrated at the conclusion of the antiviral, prophylaxis to reduce the risk of clinically significant late CMV in kidney transfer to recipients, who are CMV so negative and have a CMV serve positive donor.
Onset CMV infection, which is associated with worse. Transfer recipient, health and outcomes.
We are very pleased to be working with notable expert 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 Saito leading to organic growth.
Also, as part of activities to Advanced organic growth,
Following our first bio product launch in Israel last year, which is expected to generate approximately 2.5 million dollars in revenues. In 2025, we will be launching 2 additional bio similar 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&as.
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 all m&a transactions, which will enrich our portfolio of marketed products and complement. Our existing commercial operation.
anticipated, such transactions would 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 will support 50 Dohner beds, with a planned peak capacity of approximately 50,000 liters per year. Each is anticipated to be one of the largest collection centers for specialty plasma in the U.S.
Few weeks ago, we announced that the use and facility already received, FDA approval, and we expect that the San Antonio site to follow in early 2026.
We intend to seek subsequent inspection and approvals from the European medicine agency in the email of both sides.
The county engaged in discussion with potential customers to secure long-term sales agreements for normal Source. Plasma
as previously stated each of those 2 centers is expected to generate annual revenues of 8 million dollars to 10 million dollars in sales of normal Source, plasma at full capacity,
Turning now to an ongoing, pivotal phase 3, innovate clinical trial for inhaled alpha, 1 trips in therapy.
We continue to advance this program with its revised enrollment goal of approximately 180 subjects, and we are on track to complete an inter fertility analysis and announced its results by the end of this quarter.
With that. And I turn the call over to Kimmy for a detailed discussion of our financial results for the third quarter and 9 months of 2025 k. Please go ahead.
thank you, Amir
Stated at the top of the call, we reported strong results for the quarter and 9 months ended. September 30th 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 100, 135.8 million, and 11% increase from the 1 2, 1. 9, 1 4.
The increase in revenues was driven by the diversity of our product portfolio. Primarily attributed to increased sales of glacia in exas markets, increased sales driven by our distribution segment and VAR Zig sales in the US market.
It is important to note that we continue to achieve double digit growth even through the expected decline in glossier royalty income. As a result of the reduction in the royalty rate that went into effect during the third quarter.
The increase in both matrices is in line with a continued Improvement of product sales mix and the overall increase in our commercial scale.
Operating expenses including R&D sales and marketing and GNA and other expenses total 11.9 million. In the third quarter of 2025 similar to the level reported in the third quarter of 2024
Operating expenses total 36.8 million and 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 the development project. Timing changes.
Net income was 5.3 million or 9 cents 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 29 cents per diluted, share up 56% compared to the first 9 months of 2024.
adjusted debe de 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 EBA was $34.2 million, a 35% increase compared to the first nine months of 2024.
It should also be noted that the adjusted EV for the first nine months of 2025 was equal to the reported figure for the full year of 2024.
For the first nine months of 2025, cash provided by operations was approximately $17.9 million, which 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.
Thank you. We'll now be conducting a question and answer session.
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One moment, please. We will pull for questions once again. That is star one. Thank you.
Thank you. And our first question comes from the line of Annabelle. So, maybe with Stifel, please receive your questions.
Um, hi all. Thanks for taking my question and great progress on um operations. Um, I want to know a little bit more about the site again study and, um, how this differs from the clinical data, that's already been that you've been um, using for clinical education, so far. Um, you know, what this adds to to the package? And um, I guess maybe you can sort of talk about the population that does have this late onset CMV. Um, do you now have enough information to cover the totality of the transplant population with the prior? Um, I guess studies that were that were conducted.
Hi Annabelle. Thank you for the question. So the main difference between the current treatment population of Saito gum and this um Shield study is that currently Saito gum is primarily used either proactively at the time of
The transplantation is part of especially for high-risk patients.
which are, um,
Donor positive, recipients negative and all is part of treatment if there is actual activities of patients, you know, a few days or weeks into the post transplantation while the shield study is going to test using Saito Gum as part of late CV after patients, have been treated for a few months with the antivirals that point, The Physician start streaming down the antiviral usage and that's a risk for a flare of a CMV disease for the patient. So this is basically kind of for
Stage after a transplantation as part of dreaming down the antiviral usage.
What percentage? I don't remember top of my head, I would like to say on 20%, but I will check this and and get back to you.
Okay um great. That was that was um helpful color um then
Um, a TD where you are with enrollment clearly there's um, a lot. There's an increase in number of programs right now, um, 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 house, the um enrollment completion timeline looking and Topline data.
Okay, good. So enrollment is continuing, as you say that's an often disease. And because, you know, we...
Are and the studies with the placebo arms. So we're to 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. Um, we do see some competition from other studies, but this the site where we are working with
Active sites have highly committed to the health. Study as you said, you know, we will have the utility 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 to to the study and allow us to um,
Expedite recruitment. We expect to complete recruitment by early 2 7.
Which means, uh, Topline results, H1 29, because it's a 2-year treatment.
That's helpful. Um, all right. I'll get back into the queue. Thank you.
Thanks.
As a reminder, if you'd like to ask a question at this time, you may press star 1.
The next question is from the line of Jim Saudi of sidonian Company. Please just see you with your question.
Hi, good afternoon, and thanks for taking the questions. Um, you know, your distribution business. The last 2 quarters is really shot up, I think it was 80% growth in the second quarter. 60% growth this quarter. I I assume that's because we uh the addition of some of the new products to that uh that business are these stocking orders or or are these um actual usage? You know, or at least the kind of numbers we should expect going forward.
This is actual usage. Uh, we have a kind of a richer portfolio with launched to teaching a few products or the last 12 months into this really market. So we have a very rich portfolio currently of this distributed product. Uh, bio similar is just 1 of those, uh, products as I mentioned on the call, um, it has a 2.5 million contribution this year and we're going to launch 2 digital products. Um, you know, over the next few weeks. So you should expect this, um, level of distribution business to continue and continue growing over the next few years.
All right, and with the the um plasma collection centers in Texas. Um, I assume you're collecting some specialty plasma now, can you just give us a sense? Uh, how how much you're collecting, you know, relative to what you uh you require.
You know, or are you collecting?
Uh, the bulk of what you need now for your proprietary products. And, and when do you think that, um, or if not? Now, when do you think it will be?
Collecting enough Plasma in, in Texas to supply your proprietary products.
so,
Question. Um, we are ramping up the
Hey, over time, we will gradually increase our own self-collection, which will allow us to become more, and more, and more kind of self.
Um kind of vertical integrated and and self-sufficient. In terms of the 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 1 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 go over time and over the next few years.
okay, and then the last question for me, um,
I know you said you pointed to release some interim, battle interim data for me, uh, from the clinical trial for the AA, TD treatment. Uh, sometime I would assume in December, uh, how, how, how will you do that? Will it, 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?
Yeah, so just remember to give a little bit more color around this uh, utility analysis. So it will be conducted by 1 of the Year. Results will be publicly shared and through a press release.
In the analysis is being performed by an unblinded external dsmb.
Using data available to date who are analyzing probability of success of the study efficacy endpoints 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.
All right. Thank you.
Thank you at this time. I'll, I'll turn the floor to Brian Richie for any questions that have come in from the web.
Thank you. Um, first question. So
Can you talk about the performance of diet again to date this year? Amir and related to that? What are the significant growth drivers year to date in the business?
Yes. Um,
so as described in my presentation, we're generating significant profitable growth this year as a result of the diversity of the portfolio.
Um so gossip generated through, you know, multiple products, glasses cells in xux, markets, many Latin America and the CIS countries where we focus on aatd disease, awareness and diagnosis and we are Market leaders.
As well as growing cells of the product in Switzerland and Israel.
A varing had a strong 3 quarters in the US market. Our medical and Commercial teams are making significant successful efforts in increasing awareness of the importance of using various during a chickenpox outbreaks to treat. Um, immuno compromised populations, which are at risks that were exposed, uh, to the to the chickenpox. And as I entered this, um, pre previous question, the Israel distribution business is growing and this includes our plasma, derived products, uh, respiratory therapies, and the biosimilars, and this in addition to the cad drop camera, solid strong, sells he and Winrow, especially in the US market and the Mena region.
Specifically.
So, as I answered Annabelle on the first question, to significantly expand the use of the product, there's a need for up-to-date medical and clinical 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. We didn't care about Wells.
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 Saito gum cells have been below our plan parsley, due to inventory management in the channels. The time it takes to add the product to hospitals formularies
As well as fewer transplants performed during H1 in some of the hospitals with a product is used.
Uh, we are addressing, we have addressed, and we are addressing these issues and expect resumed growth during, uh, the next few months.
IES.
Now that those have declined to to 6%, can you elaborate on where they'll go? Um,
Next year.
Yes. As soon as I think everyone knows starting mid August.
Meaning like 1.5 months into the third quarter, we just ended and the royalties agreement with the KA reached its second phase, which includes 6% royalties on their net market sales in the US and Canada.
A disagreement is going to continue until 2040, meaning that we have a very long tail of additional 15 years of royalties. We expect the royalties to be above $10 million in 2026 and to continue to grow at a single-digit rate annually thereafter.
Important to say that we are planning for this event. This is not surprise for us and as demonstrated in our Q3 results and Kami mentioned it, and our fully 2025 guidance, we have alternative revenues and profitability sources. And that's with also, the diversity of the portfolio, and this compensating for the reduction of the royalties moving into 2026 and Beyond. Just as an example, 1 example, glassia growth in the international markets,
Doubled between 23 and 24 and expected to continue growing this year. And Beyond, this is just 1 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, Samir. Final question. Maybe you can comment on your current BD activities and, you know, similar lengthy timeline to execute a transaction.
Yes, of course. As I mentioned during the call, we continue to conduct active due diligence activities over several potential commercial targets.
uh, we expect to secure
such a transaction at the early stage of 2026.
And the time that for execution, uh, a little bit longer than what we expected. But this is because we are um, busy doing a third due diligence looking for the right transaction for comma, which will best fit our capabilities, uh, commercial and operational synergies and available resources.
Hey I'm confident that similar to the transaction. We've done in the past, it would also be successful in selecting and integrating the right assets for comma in the current phase of our BD activities.
Thanks, Samir. 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 over 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 AET Therapy Program,
We look forward to continuing to support clinicians and patients with important life-saving products that we develop at our factory and commercialize. We thank you all for your interest and support, and we remain committed to creating long-term shareholder value.
We hope you all stay 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.