Kamada Ltd. (KMDA) Q4 2024 Earnings Report, Transcript and Summary

Greetings, and welcome to the Kamada Fourth Quarter and Full Year 2024 Earnings Conference Call. At this time all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Brian Ritchie with LifeSci Advisors. Thank you, sir. 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 three months and full year ended December 31, 2024. 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 5, 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?

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 performance was excellent over the course of 2024, leading to record top and bottom line financial results. Total revenue for 2024 were $161 million, coming in at the top end of our guidance range and representing a 13% increase over 2023 revenues. Adjusted EBITDA was a record $34.1 million also at the top end of our expected range, representing 42% year-over-year growth. These outstanding results were driven the strength across our entire portfolio, improvement in the overall sales mix and increased sales of our two most profitable growth drivers, KEDRAB and CYTOGAM. In 2024, we generated $47.6 million in cash from operations, resulting in a year-end strong balance sheet of $78.4 billion in cash. Based on our very strong financial results and solid cash position, we are pleased to announce earlier today that our Board of Directors declared a special cash dividend of $0.20 per share to be payable in April. Importantly, we are well positioned to continue our growth with ample liquidity to execute on the advancement of our main growth pillars. The declaration of a dividend to our shareholders reinforces our confidence in the company's business prospects and demonstrates our commitment to generating shareholder value. Based on our robust operational and financial performance, we entered 2025 from a position of significant strength and with a highly favorable outlook. For fiscal 2025, we expect to continue delivering double-digit profitable growth driven by our diverse commercial portfolio marketed in over 30 countries, and we are forecasting 2025 annual revenues of $178 million to $182 million and $38 million to $42 million of adjusted EBITDA. The midpoint of our 2025 guidance represent an increase of approximately 12% in revenues and approximately 17% in adjusted EBITDA, respectively, over our 2024 results. I will now proceed to briefly review our growth strategy and operational priorities for 2025 and beyond. I will then turn the call over to Chaime to discuss our 2024 financial results in greater details. On prior calls, I've outlined the four pillars of our growth strategy. Organic growth from our existing commercial portfolio, business development and M&A transactions to support and expedite our growth, expansion of our plasma collection operation and our ongoing Phase 3 pivotal trial for inhaled AAT product that is targeting an over $2 billion market. Throughout 2024, we made significant progress advancing each of these value-driving catalysts and in 2025 they remained the key focus of our growth strategy. I will begin with our commercial portfolio of six FDA-approved products marketed in over 30 countries. Our two main growth catalysts in 2024 were KEDRAB and CYTOGAM, resulting from increased demand in the U.S. market. We also experienced a meaningful increase in GLASSIA sales in multiple international markets, where we partnered with strong local distributors, specializing in rare respiratory diseases. During the year, we also continued to successfully build our presence and future prospects in the MENA region, participating and winning local tenders. In January 2025, we announced the award of a three-year contract with an international organization for the supply of KAMRAB and VARIZIG in Latin America. We are pleased with the significant three-year supply agreement which we believe validates the global strength of our leading specialty in a globulin portfolio. We expect total revenue from both products throughout the three years to be approximately $25 million. Winning this tender is indicative of a substantial commercial potential of our broad product portfolio in the international markets beyond the U.S. and Canada, and we intend to continue to pursue digital commercial contracts in key strategic territories. Moreover, in 2024, we successfully launched our first biosimilar product in Israel, and we expect to launch two additional biosimilars in 2025. We have several other biosimilar products in the pipeline to be launched in the coming years. We expect 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 five years. During 2024, we continue to demonstrate our ability to convert adjusted EBITDA into operational cash. To this end, in 2025, we expect to secure compelling new business development in licensing, collaboration and/or M&A transactions. Such agreements generate operational and/or commercial synergies with our current commercial portfolio. Turning now to our plasma collection centers. In 2024, we opened our second plasma collection center in Houston, Texas. The new center in Houston is expected to be one of the largest sites for specialty plasma collection in the U.S. and will also collect normal source plasma to be sold to third parties. In addition to the new Houston center, construction of our third plasma collection site in San Antonio, Texas, is now complete, and the site will be opened this month. This 12,000 square foot San Antonio center will support over 50 donor beds with an estimated total collection part of approximately 50,000 liters annually. As a reminder, each of our two new plasma collection centers is expected to contribute annual revenues of between $8 million to $10 million in sales of normal source plasma once at its full capacity. Turning now to our inhaled AAT therapy. As we recently announced, the U.S. FDA confirmed its agreement with our previously proposed relaxed two-sided type 1 error rate control modified from 5% to 10%, which means p-value of 0.1. Based on the accepted change in the p-value as well as additional revision to the statistical analysis plan, we are reducing the study sample size from 220 patients to approximately 180 patients while maintaining the statistical power of the trial. We've also announced that we plan to conduct a futility analysis by the end of 2025. With that, I'll now turn the call over to Chaime for a detailed discussion of our financial results for the fourth quarter and the full year 2024. Chaime, please go ahead.

Thank you, Amir. As Amir stated at the top of the call, our results were excellent for both the fourth quarter and full year of 2024. Total revenues for full year 2024 were a record $161 million, up 13% compared to the $143 million in 2023. The reported revenues met our 2024 annual guidance. The increase in revenues was primarily attributable for increased sales of KEDRAB, which contributed $50 million of total sales during 2024. As a reminder, in late 2023, we announced an eight-year extension of the distribution agreement with Kedrion, which included their commitments to acquire minimum quantities of KEDRAB totaling $180 million for the first four years of the amended terms, 2024 through 2027. Kedrion's minimum commitment for the remaining three years of 2025 through 2027 now stands at $135 million. The increase in annual revenue was also attributable to increased sales of CYTOGAM, which were $23 million, up 31% compared to the 2023 sales [indiscernible] were $39 million, up 7% over the corresponding quarter in 2023. Gross profit and gross margins for 2024 were $70 million and 43% compared to $55.5 million and 39%. In 2023 the increase in profitability was attributable to increase in sales as well as an improvement in our overall product sales mix. Gross profit and gross margins for the fourth quarter of 2024 were $17 million and 44% compared to $14.4 million and 40% in the fourth quarter of 2023, representing a 4 basis point increase. Operating expenses, including research and development, sales and marketing and general and administrative expenses totaled $49.9 million in 2024 as compared to 45.4% in 2023. The increase in operating expenses were in line with our expectations and primarily attributable to an increase in sales and marketing costs associated with marketing activities in the U.S. as well as increased R&D costs primarily due to advancing the inhaled AAT clinical trial. Net income was $14.5 million, or $0.25 per diluted share, for the full year 2024 as compared to $8.3 million, or $0.15 per diluted share, for full year 2023, representing a 75% increase year-over-year. The reduction in net income in the fourth quarter of 2024 as compared to 2023 was attributable to increased financial expenses associated with revaluation of contingent consideration, which represents our higher future sales forecast, resulting in increased future earn-out payments on account of the 2021 product acquisition. Adjusted EBITDA for 2024 was an all-time record, $34.1 million, up 42% from the 2023 adjusted EBITDA of $24.1 million. 2024 reported adjusted EBITDA meets our 2024 annual financial guidance. Cash provided by operating activities was $10.4 million for the fourth quarter of 2024 – demonstrating the company's ability to convert its earnings into significant positive cash flow. As Amir previously indicated, we retained strong financial position as demonstrated by our year-end solid balance sheet, which will support our future continued growth and ability to execute on our strategic four growth pillars. That concludes our prepared remarks. We'll now open the call for questions.

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Our first question comes from Annabel Samimy with Stifel. Please proceed with your question.

Hi, everyone. Thanks for taking my questions and great quarter. I wanted to ask you about the futility analysis that you're going to be conducting for the AAT, inhaled AAT program. Can you just talk about what will be looked at? Will the information be blinded to you? Is it independent more of a statistical analysis? Or are they looking at the actual endpoints? Are you going to be reporting anything? I don't know what are the potential outcomes we can see there. And then separately, if you could talk about some of the additional growth drivers for KEDRAB and CYTOGAM? It looks like KEDRAB is more about international expansion, do you have any – and for CYTOGAM, are you planning any other clinical presentations or clinical studies to present at various medical conferences?

Thanks Annabel for the questions. I will start with the futility analysis question. So yes, we will be blinded. So the data will be reviewed by an external DSMB type of group that will be actually be unblinded. But while the company the sponsor remains blinded, we decided to run this analysis based on the changes that we have implemented in the statistical plan, reduction of the sample size. We are basically reaching a point second part of this year that we are going to have sufficient interim data to perform a meaningful statistical analysis. We will be looking at actual not us basically the external group will be analyzing and looking at efficacy data, conditional efficacy data in order basically to give us feedback related to the study success ratio if it may. But that's, of course, going to be as in interim futility analysis, that's going to be basically a yes, no type of question and the company will not be seeing the actual data.

In terms of the efficacy data, are they looking primarily at the primary endpoints that you've laid out or additional?

Correct.

Okay, all right.

Futility analysis allows you basically to post one question to the DSMB and they are looking at this data and basically giving you feedback based on this, which is kind of a yes, no type of question – answer, sorry, yes, no type of answer.

Okay, and what would be the – sorry, just on the futility analysis, do you either expect to continue as is expand – do you expect to either continue, expand or stop the program altogether, are those your three options there?

Correct.

Okay.

As always in CT analysis, three options: continue, make modification based mainly on sample size or need to stop the study, because the kind of futility data.

Okay, great.

Related to your – second question was related to 2025 prospects. That was the question.

Yes. Well, the specific growth drivers for KEDRAB and CYTOGAM. So KEDRAB, that just continuation of expanding contracts globally?

Correct. So, when we talk about KEDRAB, we mean only U.S. So, when we say $50 million sale of KEDRAB, this is our agreement with Kedrion. We refer to the non-U.S. product is KAMRAB just as a matter of classification.

Okay.

So as you remember, we had an agreement for $180 million of sales for the full year minimum for the 2024, 2025, 2026, 2027 for the first year, so average of $45 million, but the first year 2024, Kedrion already purchased from us $50 million of the product. So above the minimum quantity. Then it means that for the remaining of those next three years, 2025, 2026, 2027, the minimum, and I emphasize minimum commitment is $135 million.

Okay.

Ex-U.S., we are continuing to grow the business. We announced in January winning with international tender for Latin America. We are the supplier in Canada, Australia, some European countries, Israel and the kind of international markets. So the product is growing not just in the U.S. market. Regarding CYTOGAM, yes, we are advancing clinical work with additional U.S. best KOLs in leading transplantation centers. We will announce those presentations during the year once they've basically been accepted to the different conferences and industry meetings, and we've seen a nice increase between 2023 and 2024 in terms of product sales in the U.S.

Okay. And if I could just ask one more follow-up. I have to ask this question. We don't often see special dividends from development, well, you are profitable, obviously, but still development-stage companies. So what was the deciding factor there to offer a special dividend?

Yes. So first of all, we believe that Canada is in a mature phase that can basically be a commercial development pipeline and the company that pay dividend. The dividend that was specified by the Board, driven by the very strong financial results of 2024 and our strong outlook for 2025 believe we have sufficient funds, very solid cash position to be able to pay the dividend while we continue with our BD M&A activities according to the plan. Our goal is to execute such M&A and BD transactions already in 2025, and we have sufficient resources, while we're continuing to generate more and more cash from our operator moving forward. So we can do both.

Could that be an indication that you know what kind of you're going to do and the size of the BDs that you're going to be doing?

We are screening multiple opportunities, and we are hopeful that things we much already in 2025. It's going to be a commercial stage assets that will help us basically to accelerate our growth.

Okay. Great, thank you.

Thank you.

Our next question comes from Anthony Petrone with Mizuho Group. Please proceed with your question.

Thanks and hope you are doing well. Great to see obviously the excellent results for 2024. Maybe to start with plasma collections. You have the two operating centers and the third is on the way to being open here shortly. So maybe just a little bit on the third center, the timing to reach that peak revenue target of $8 million to $10 million and then the mix of what will be collected there, how much will be specialty plasma versus stand plasma that you would go on to sell to third parties? And then I'll have a couple of follow-ups. Thanks.

Okay. Yes. So the third center, San Antonio is going to be opened this month based on the pace that we are seeing in Houston, we believe it's around 24 to 30 months but it takes basically two center at least based on the pace that we've seen in Houston since we opened around six months ago. So we are on track Houston, and we believe that we can also execute the same level of portfolio in San Antonio. As you mentioned, that both centers will be collecting specialty plasma for our needs and NovaSource plasma that will be sold out to external parties. Approximately 20% to 25% for each center will be specialty, maybe a little bit more, and the rest will be normal source plasma. This correlates with the $8 million to $10 million revenue per center from selling normal source plasma to external parties. So if you do the math, and I know you're familiar with the price per liter of plasma, you basically can see how we came up with this ratio.

Fair enough. And I'm just wondering, as you're building or critical mass here how the plasma collections, that operation, but just factoring it against third-party sales as well as your own work in process inventory needs, how that plays out from an adjusted EBITDA margin standpoint. So just a little bit on the margin profile today of plasma collection and, let's say, a year or two years from now, where that margin profile can trend to?

Okay. So on the specialty plasma, this is going to be intercompany type of transaction. You're not going to see this is part of our top line. And it will have an effect on our cost of goods because every little plasma that we collect is cheaper than it plasma that we currently buy from external suppliers. So, this will be part of our overall efficiencies and kind of growing the company. And I think you've seen it also in our country port over the last few quarters and moving into 2025, our ability to grow the company in a very effective way and benefiting from the economy of scales. In terms of selling plasma to the external parties, so for me that includes the potential or was expected margins, selling plasma to external will result in anywhere between 10% to 20%, 25% gross margin.

That's helpful. And then just pivoting to the BD&L side of the story. Obviously, a good collection of hyperimmune immunoglobulin products. You mentioned, again, obviously, you have a special dividend going out, but the pipeline for follow-on deals, whether in-licensing or potentially M&A is still robust. I'm just wondering when we think about just sort of the landscape out there, it feels like the play here is to continue to build in hyperimmune globulin product specifically? And maybe just give us an idea of that broader landscape, Amir and maybe which areas specifically you're taking a look at? And obviously, you have exposure to rabies, cytomegalovirus disease for kidney transplant, the two biggest products. Just wondering, as you look at that hyperimmune space, what other white areas are there that you can capitalize on? Thanks again.

In terms of BD and M&A opportunities, as you said, we're looking for assets which are in synergy with our current commercial footprint in the U.S. market, we are covering all key transplant centers, and we have a very strong presence in the specialty plasma space. We are working with infectious disease specialists and we have, of course, experienced in alpha-1 inhaled respiratory specialties. So these are the areas which are kind of the first areas that we have been looking at and we are screening opportunities. In general, any drug arrived assets, of course, is of great interest for us, like we've done with CYTOGAM the ability to also transfer the production to our facility create significant synergies. But we're looking a little bit broader in order to be able to actually really execute those type of transactions already this year, as I mentioned. We're looking also for distribution businesses. that will be synergistic to what we're currently doing. Reminding you that we have strong presence in the EMEA region in Israel, U.S., Canada, other sales are relevant areas for us in terms of where we are searching for any BD opportunities.

Thank you again. Thank you very much.

[Operator Instructions] Our next question comes from James Sidoti with Sidoti & Co.

Hi, good afternoon. Thanks for taking the questions. A couple of questions on gross margin. For your proprietary products, it was up about, I think, about 700 basis points. Is that due to the mix of KEDRAB in the current quarter?

Mostly specially two profitable products that have the biggest impact on our gross margins are KEDRAB and CYTOGAM in the U.S. market. So a favorable sales mix and improve the increased sales in the U.S. market always helps us in terms of our gross margins. So that's yes to your question.

And what will be the impact when you start using more of your more of the plasma that you get from your own in-source plasma centers as opposed to buying it. What do you think the impact on that proprietary gross margin could be?

It will have an effect, but I just want to also caution that it will take time. It's a process that takes time to actually start replacing the plasma that you currently buy with our own collective plasma. So the overall mix, if I may, of internal plasma collection of cells plasma collection, increased sales in the used market, economy of scales and just making more in our plant all those different aspects play together in creating the efficiency that you're saying. It's difficult, definitely in such a public setting to point a specific parameter. We had a very efficient operation. The fact that we started last year to manufacture CYTOGAM in our own plant, the combination with GLASSIA is growing significantly in ex-U.S. market and we make more GLASSIA lot purchasing and in manufacturing by us, all of these plays basically together.

Okay, all right. Thank you.

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

Thank you. So in closing, the successful execution of our profitable growth strategy is well reflected in our record top and bottom line 2024 financial results. as well as with the declaration of a special cash dividend. We're excited about our opportunities to advance our four strategic growth pillars. We look forward to continuing to support technician patients with important life-saving products that we develop, manufacture and commercialize worldwide. We thank you, our investors for their support and remain committed to creating long-term shareholder value. We hope you all stay happy and safe. Thank you for joining us today.

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