Earnings Call Transcript - KMDA Q2 2024

Operator, Operator

Greetings and welcome to Kamada Limited's Second Quarter 2024 Earnings Conference Call. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Troy Williams, LifeSci Adviser. Thank you, Mr. Williams, you may begin.

Troy Williams, LifeSci Adviser

The 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 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 contents of this conference call contain time-sensitive information that is accurate only as of the date of the live broadcast, Wednesday, August 14, 2024. 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

I would like to provide an overview of our growth strategy, which is clearly reflected in the strong financial results we achieved in the second quarter and the first half of 2024. I will outline the key drivers we are focusing on for the remainder of this year and into 2025. After that, I will hand the call over to Chaime for a more detailed review of our financial results. Following that, we will open the floor to your questions. I'm pleased to report that the solid financial and operational start to 2024, which we highlighted last quarter, continued through our second quarter, reinforcing our growth strategy. Kamada’s growth strategy is based on four main pillars: first, organic growth of our existing commercial portfolio of six FDA-approved products available in over 30 countries; second, mergers and acquisitions that are expected to enhance and accelerate our growth; third, the plasma collection centers we are establishing; and fourth, the ongoing Phase 3 pivotal trial of our inhaled AAT product targeting a market exceeding $2 billion. In the first six months of 2024, we made significant strides in advancing each of these growth catalysts, which I will detail shortly. To start, let me provide a high-level summary of our financial performance. Total revenues rose 13% to $42.5 million in the second quarter compared to the same period in 2023, and adjusted EBITDA for the quarter was $9.1 million, which is a 51% increase from the previous year. For the first half of 2024, total revenues climbed 18% to $80.2 million compared to the prior year, with first half adjusted EBITDA increasing by 68% to $16.6 million, yielding a 21% revenue margin. We are particularly encouraged by this significant rise in profitability. Additionally, for the first half of the year, we reported $15 million in cash from operating activities, showcasing our ability to turn our reported adjusted EBITDA into operational cash flow. Given our strong performance and expectations for continued financial results in the second half of 2024, consistent with those achieved in the first half of the year, we are reaffirming our full-year revenue guidance of between $158 million and $162 million and adjusted EBITDA guidance of $28 million to $32 million. We will continue to benefit from the strength of our diverse commercial portfolio, particularly our six FDA-approved products, with KEDRAB and CYTOGAM being our two key products. Notably, these products showed significant year-over-year growth in the first half of the year compared to the first six months of 2023. In the first quarter, we successfully launched our first biosimilar product in Israel, and we expect to introduce our next biosimilar product by the end of this year, with several more in the pipeline for future launches. We foresee biosimilars becoming an increasingly significant part of our distribution business in Israel, with potential annual sales ranging from $30 million to $34 million. Importantly, we maintain a very solid balance sheet. By the end of the second quarter, we had approximately $56.6 million in cash, giving us the financial strength to accelerate growth in our existing business and pursue attractive business development and M&A opportunities, a process we are actively involved in that could expand our commercial portfolio. These opportunities are projected to support our sustained double-digit growth beyond 2024. Regarding our plasma collection centers, we are making strides with Kamada’s plasma operations in the U.S. We are successfully enhancing specialty plasma collection capacity at our first center in Beaumont, Texas, which focuses on collecting Anti-Rabies and Anti-D plasma types, and we plan to open a new center in Houston, Texas by the end of next month, while also advancing the construction of a third site in San Antonio, expected to open in early 2025. Each new collection center is anticipated to contribute annual revenues of between $8 million and $10 million. Looking ahead, we continue to enroll participants in our ongoing pivotal Phase 3 InnovAATe clinical trial for inhaled AAT therapy. Earlier this year, we submitted an IND amendment to the FDA, which included a revised statistical analysis plan and study protocol, and, if approved, may allow us to accelerate the program. We expect to receive further feedback from the FDA before the end of the year. As previously stated, we are also in discussions regarding potential partnerships for this promising late-stage investigational product candidate, which targets a market of over $2 billion. Now, I will turn the call over to Chaime for a detailed discussion of our financial results for the second quarter and first half of 2024. Please go ahead, Chaime.

Chaime Orlev, CFO

Thank you, Amir. As Amir stated at the top of the call, our performance continues to be excellent through the midpoint of 2024. Total revenues for the quarter were approximately $42.5 million, a 13% increase compared to the second quarter of 2023. For the first half of the year, total revenues were $80.2 million, up 18% from the prior year period. The first half sales represented 50% of the midpoint of our annual guidance. The year-over-year growth was primarily driven by increased sales of both KEDRAB and CYTOGAM due to increased demand for the two products in the U.S. market. Approximately 70% of our revenues during the first half of 2024 were generated by sales in the U.S. market. Total gross profit for the second quarter of 2024 was $19 million, representing a 45% margin compared to the $14.4 million or 39% margin in the prior year period. Total gross profit for the first six months of 2024 was $35.7 million, representing a 45% margin compared to $26.3 million and a margin of 39% for the first six months of 2023. Operating expenses for the first six months of 2024 totaled $26 million, an increase of 11% over the prior year period, which was in line with our expectations. The planned increase was in support of our expanded commercial activities as well as our ongoing Phase 3 InnovAATe trial. Net income for the second quarter was $4.4 million or $0.08 per diluted share, as compared to net income of $1.8 million or $0.04 per share recorded in the second quarter of 2023. For the first half of 2024, net income was $6.8 million or $0.12 per share versus negligible income for the same period of 2023. Adjusted EBITDA was $9.1 million in the second quarter of 2024 as compared to $6 million in the second quarter of 2023. Adjusted EBITDA was $16.6 million in the first six months of 2024 as compared to $9.9 million in the first six months of 2023. The adjusted EBITDA for the first half of the year represents a 21% margin of revenues at 55% of our midpoint annual guidance. Finally, our financial position remains strong and provides us the strength and flexibility to accelerate the growth and profitability of our existing business and pursue compelling new business development opportunities, which collectively will continue to support double-digit top and bottom-line growth rates beyond 2024. That concludes our prepared remarks. We will now open the call to questions.

Operator, Operator

The first question comes from Annabel Samimy with Stifel. Please go ahead.

Annabel Samimy, Analyst

Hi everyone. Thanks for taking my questions. Great quarter. So I had a few here. First, on the inhaled AATD I'm just was curious, I know you're saying that you expect a response from FDA before the end of the year. But is there any dialogue during this period? And do you have any sense of where this might land? Is there any kind of pushback that you expect? And if they do, in fact, accept the new statistical plan, how could that impact the timing of the trial? How does it change the sizing? And maybe you can just help us understand what kind of impact that would have? So that's my first question. And then the second is, if you could help us understand where enrollment is at this point? Has the enrollment become more competitive as we see a couple of other players in the market, I'm just trying to understand how you are in terms of timing there?

Amir London, CEO

Thank you for your question, Annabel. We submitted the revised Statistical plan to the FDA in the second quarter and expect to receive feedback before the end of the year. We have yet to receive any feedback, so we are waiting for the initial response. If necessary, we will engage in further discussions with the FDA to clarify the potential changes to the p-value for efficacy. Enrollment is currently at about 40% to 45% of the study goals. Recruitment poses challenges due to the rarity of the disease and the nature of the placebo-controlled study, but we are making progress. We have recently opened additional sites and anticipate completing enrollment by the end of next year. Any potential reduction in the number of patient subjects will result in only a few months' delay in recruitment.

Annabel Samimy, Analyst

Okay, great. And if I can have a follow-up on CMV. When can we expect the next data releases? And any movement on the guidelines yet with regards to the prophylaxis in high-risk patients?

Amir London, CEO

You mean CYTOGAM in CMV. That was the question?

Annabel Samimy, Analyst

Yes. Sorry, CYTOGAM in CMV.

Amir London, CEO

We are collaborating with several U.S. key opinion leaders on various studies and data collection efforts that utilize existing historical data to assess the benefits of CYTOGAM compared to the standard of care, particularly for high-risk patients. The key opinion leaders are also working on the consensus document, which is reviewed and discussed periodically. We anticipate that this will be part of the upcoming discussions in that forum. Overall, I can share that our efforts since 2023 to effectively relaunch the product in the U.S. market, supported by new clinical and medical data and direct engagement with physicians, have been productive. We have observed positive results in CYTOGAM sales and performance over the past six months, and we are hopeful that this momentum will carry into next year and beyond.

Annabel Samimy, Analyst

Okay, great. Thank you.

Operator, Operator

Thank you.

Richard, Analyst

Hello Amir and Chaime. This is Richard with Zachs. I'm calling on behalf of David Bautz as he has a few questions for you. I believe you already addressed the first one regarding the potential revisions to the timelines for the Phase 3 InnovAATe trial. His next question concerns the AAT program. Are you aiming to secure a global commercialization partner or are you considering smaller regional partnerships? Could you elaborate on that a bit? I have just a few questions.

Amir London, CEO

Yes. We are in discussions with potential partners, primarily in the U.S. and Europe, as these are the key markets with significant business potential, including patients and regulatory bodies. We may have one partner for both regions or two separate partners for each territory. Our focus remains on the U.S. and European markets, and we are collaborating with the FDA and EMA to secure product approval.

Richard, Analyst

Got it. Okay. Thank you. Next question, business development opportunities. Are you guys open to in-licensing earlier stage assets? Or is the focus going to simply be on commercial stage products?

Amir London, CEO

The focus is on commercial stage or near commercialization stage. So we would like to support the growth of the company, the commercial growth of the company, in addition to our strong organic growth, we would like to support it by M&As, the investment that was made last year by the FIMI fund was specifically targeting another M&As. I think we and the Board are happy with the transaction we've done late '21 and the way that we've integrated the new products we acquired back then into Kamada establishing our U.S. commercial team, and we would like to build on that success and to leverage that success with additional commercial products.

Richard, Analyst

Got it. All right. Thank you, Amir. Final question. This is positive cash flow starting to ramp up, which is fantastic. So keeping your retail ownership in mind and keeping our retail investor network in mind? Any thoughts to potentially paying the dividend in the future?

Amir London, CEO

It's a question or a comment.

Richard, Analyst

It's a question.

Amir London, CEO

So can you repeat the question, please?

Richard, Analyst

Yes. Your positive cash flow is beginning to increase. Considering your retail ownership and our retail investor network that are interested in your story, have you considered the possibility of paying a dividend in the future? Have you thought about that or discussed it?

Amir London, CEO

So we might pay a dividend in the future. Currently, we are focused on M&As and BD transactions like you asked me on the previous question. And we'd like to utilize the money we are generating from the existing business to continue growing the business through M&As. In the future, a dividend could also be an option. This is not something currently discussed or approved by the Board.

Richard, Analyst

Got it. Okay. That's it. Thank you very much, Amir.

Amir London, CEO

You're welcome. Thank you.

Operator, Operator

Next question comes from the line of Troy Williams from LifeSci Advisors. Please go ahead.

Troy Williams, LifeSci Adviser

Thanks. Just wanted to see if you could kind of expand on what's your current market share of KEDRAB and your expectations there for the future?

Amir London, CEO

So we believe that in the U.S. market, KEDRAB is anywhere between 40% to 50% market share. We continue growing the product. We continue taking market share. And we believe the product has still room to grow above the 50% that we have been discussing in the past. We have the $180 million guaranteed revenues for this coming four years, and this is like a minimum commitment by Kedrion, and we believe that it can grow even further.

Operator, Operator

Mr. Williams, are you done with the question?

Troy Williams, LifeSci Adviser

Yes, that was all. Thank you.

Amir London, CEO

Thank you.

Operator, Operator

Ladies and gentlemen, we have reached the end of the question-and-answer session. I would now like to turn the floor over to Amir London for closing comments.

Amir London, CEO

Thank you very much. So in closing, our successful execution of our growth strategy is reflected in the strong financial results we delivered in the second quarter and the first half of 2024. We are excited about our opportunities to advance the four main pillars of our growth strategy described during the presentation. We look forward to continuing to support clinicians and patients with the important life-saving products that we develop, manufacture, and commercialize. We thank all of our investors for their support and remain committed to creating long-term shareholder value. We hope you all stay healthy and safe, and thank you for joining us on today's call. Good day, everyone.

Operator, Operator

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