Kamada Ltd. Q1 FY2025 earnings call

• Strong first quarter results with double-digit profitable growth. Total revenues increased 17% y-o-y, adjusted EBITDA up 54% y-o-y.
• Four-pillar growth strategy: organic commercial growth, business development and M&A transactions, plasma collection operation, and advancement of pivotal Phase 3 inhaled Alpha-1 program.
• Initiated a comprehensive post-marketing research program for CYTOGAM with 10 studies to demonstrate product advantages in CMV disease management.
• Expect to launch two additional biosimilars later in 2025 and have others in pipeline for future launches, with biosimilar portfolio aiming for $15M-$20M in annual sales within five years.
• Expanded plasma collection operation with opening of third location in San Antonio, Texas, with each collection center expected to contribute $8M-$10M annually in normal source plasma sales once at full capacity.
• Progressing on InnovAATe clinical trial for inhaled Alpha-1 Antitrypsin therapy with 55% enrollment and on track for interim futility analysis by end of 2025.

Total revenues for the first quarter were $44 million, an increase of approximately 17% year-over-year. Adjusted EBITDA was $11.6 million, an increase of approximately 54% year-over-year. Growth was primarily due to increased sales of GLASSIA and KAMRAB in ex-U.S. markets, VARIZIG sales, and GLASSIA royalties income. Gross profit was $20.7 million with a 47% margin in Q1 2025, compared to $16.7 million and 44% in Q1 2024. Net income was $4 million or $0.07 per share in Q1 2025, up 67% from $2.4 million or $0.04 per share in Q1 2024.

• Reiterated 2025 annual guidance: anticipated annual revenues of $178 million to $182 million and $38 million to $42 million of adjusted EBITDA.
• Midpoints of guidance represent approximately 12% increase in revenues and approximately 17% increase in adjusted EBITDA over 2024 results.
• Will monitor progress during second quarter and update guidance if strong performance continues.

• Potential impact of evolving trade tariffs: currently, no direct impact on specific products, but situation will be monitored.
• NIH spending cutbacks: not currently expected to impact business due to nature of critical care treatments provided.

Q: Hi all, thanks for taking my question. Great start of the year. I had some questions around the different growth contributors. I noticed that CYTOGAM has been cited as a growth contributor this quarter. So I was just wondering, with your expanded investment in clinical studies for CYTOGAM, is that -- should we read into anything that there's -- what prompted this? Has it reached a plateau right now? Or maybe does it signal anything for the potential to update guidelines based on the data that you have to date? Just wanted to understand the decision for making this investment.

A: Thanks, Annabel. So we emphasized the basically year-over-year growth -- and basically, Q1 2024 was kind of similar to Q1 2024 in terms of the sales. Just a reminder, end of 2023, we launched the new batches from our own production. So Q1 of 2024 was strong with this fresh inventory that was basically shipped to the market. So we had a strong quarter back then. So when comparing the quarter-to-quarter, year-over-year, CYTOGAM didn't have a major contribution to the growth. The growth came from other products. We're very happy to see the strength of our portfolio, the diversity of our portfolio, including GLASSIA ex-U.S., KAMRAB ex-U.S., VARIZIG in the U.S. market and the GLASSIA royalties had a significant contribution to the growth of the business. In general, we spoke about it in previous quarters. The fact that we have six FDA-approved products and we're currently active in over 35 different countries, territories makes a very significant, a very strong portfolio that can continue growing organically in the next few years.

Q: Hi, good morning. Thanks -- good afternoon, actually. Thanks for taking the question. Just a follow-up on the CYTOGAM post-marketing study. Can you talk a little bit about the timing of that? When do you expect that to be completed?

A: Because it's an array of 10 different studies. So each one of those has its own time line. Some are things that are done quicker, especially the non-human clinical studies, but more of kind of the in vitro analysis that we are doing. So some of it will be available already later this year into 2026 and some of the work will continue all the way to 2027, 2028. In general, I'll say it's around a 4-year program that we have launched across multiple sites, multiple KOLs and basically kind of covering the majority of the relevant CMV management and preventive in organ transplantation.

Q: The tax rate, you reported a 40% tax rate compared to a 3% tax rate a year ago. I guess two questions. What happened? And are those real cash taxes? Or was that a non-cash expense?

A: The tax changes in deferred tax liability, you can refer to our cash flow to see that it had no cash effect.