Kamada Ltd. (KMDA) Earnings Call Transcript & Summary

Greetings, and welcome to Kamada Corporate Update Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Brian Ritchie, Managing Director of LifeSci Advisors. Thank you. Please go ahead.

Thank you. This is Brian Ritchie with LifeSci Advisors, and 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 issued a press release announcing the company's decision to discontinue its Phase III inhaled AAT InnovAATe clinical trial, while providing an update on its financial projections, which are the subject of today's corporate update call. 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 this -- of the live broadcast, Monday, December 8, 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, 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 will provide a brief update on today's news, and we will then open the call for questions. As Brian mentioned, this morning, we issued a press release announcing the discontinuation of our Phase III inhaled AAT InnovAATe clinical trial due to futility. The independent unblinded, DSMB advised us that based on the prespecified interim futility analysis, which the company has requested the InnovAATe trial of Inhaled AAT for the treatment of Alpha-1 deficiency is unlikely to demonstrate a statistically significant benefit in its primary endpoint of lung function as measured by FEV1. Based on this outcome, we are discontinuing this program. This decision is solely related to the limited likelihood of a successful efficacy outcome should the study continue to conclusion, and it is not reflective of any safety concerns related to the inhaled AAT treatment. We are taking the appropriate steps to inform all participating sites of our decision to discontinue the study in an organized and efficient manner. We are grateful for the support of the patients who participated in the study, the Alpha-1 community, physicians, clinical site teams, regulators and all stakeholders who contributed to the study. Importantly, we, Kamada remain committed to the Alpha-1 community through continued supply of Glassia, our leading AAT-IV treatment marketed internationally, including in the U.S. and Canada through our license agreement with Takeda. While we are disappointed that the trial did not pass this milestone and it is being discontinued, it's important for me to clearly emphasize that our business remains very strong, and we are well positioned to continue and support our 2026 and future growth prospects even without the inhaled AAT products. I take this opportunity to also reiterate that based on our consistent strong performance during 2025, we are on track to meet our full year 2025 revenue guidance of between $178 million to $182 million and our annual adjusted EBITDA of between $40 million to $44 million. As for 2026, we project double-digit growth in revenues and profitability through our robust commercial portfolio, including 6 FDA-approved specialty plasma-derived products marketed in over 30 countries, our growing biosimilar portfolio in Israel and the expansion of our plasma collection capacity. The detailed financial guidance for 2026 will be provided soon in early January. Importantly, in addition to our strong organic growth, we continue to focus on pursuing attractive new commercial stage business development opportunities, leveraging our strong cash position to support continued long-term profitable growth. That concludes my prepared remarks. Operator, we are ready to open the call to questions.

[Operator Instructions] Our first question today is coming from Jim Sidoti of Sidoti & Company.

Can you tell us what was the cost of conducting the trial? And how quickly do you think those costs will fall off?

Thank you, Jim. So annual study costs during recent years were between $5 million to $6 million per year. In early 2026, we will still require some budget for the study closure activities. But beyond that, those costs will be eliminated and our EBITDA will grow accordingly.

Okay. And do you expect anything in the near term to offset that? Or do you think that should -- that $5 million to $6 million of annual costs should fall through to the bottom line?

All the way to the bottom line.

[Operator Instructions] At this time, I'd like to turn the floor back over to Mr. London for closing comments.

Thank you very much, operator. So in closing, we continue to invest in our growth strategy, with continued progress made in organic growth of our existing commercial portfolio, business development and M&A transaction to support and expedite our growth and the expansion of our plasma collection operation. We look forward to continuing to support clinicians and patients with the important life-saving products that we develop, manufacture and commercialize. We thank you all for your support and we remain committed to creating long-term shareholder value. Thank you. Have a good day.

Ladies and gentlemen, this concludes today's event. You may disconnect your lines or log off the webcast at this time, and enjoy the rest of your day.