Kamada Announces Reduced Sample Size for Inhaled AAT Phase 3 Trial Following FDA Feedback
核心洞察
Kamada anticipates achieving its 2024 financial goals, projecting revenues between $158 million and $162 million and adjusted EBITDA between $32 million and $35 million.
The company forecasts continued double-digit profitable growth for 2025, with revenue guidance of $178 million to $182 million and adjusted EBITDA of $38 million to $42 million.
Following positive feedback from the FDA, Kamada plans to reduce the sample size for its inhaled Alpha-1 Antitrypsin (AAT) Phase 3 trial to approximately 180 patients.
Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA) announced it expects to meet its 2024 financial guidance, projecting revenues of $158 million to $162 million and an adjusted EBITDA of $32 million to $35 million. Building on this momentum, the company anticipates continued double-digit profitable growth in 2025.
The biopharmaceutical firm, specializing in plasma-derived therapies for rare and serious conditions, forecasts 2025 revenues between $178 million and $182 million, with an adjusted EBITDA of $38 million to $42 million. This represents a 13% increase in revenues and a 19% increase in adjusted EBITDA compared to the midpoint of the 2024 guidance.
Strategic Growth Pillars
Amir London, Kamada’s CEO, highlighted the company's strategic objectives for 2025, stating, “We enter 2025 from a position of significant strength and are pleased with the progress made over the past year. We look forward to achieving our value generating objectives for 2025 driven by our four strategic growth pillars, comprising of organic commercial growth, the execution of business development and M&A transactions, our plasma collection operations, and the further advancement of our pivotal Phase 3 Inhaled AAT program."
Kamada aims to leverage its financial strength to secure new business development and M&A transactions in 2025, complementing its existing commercial infrastructure. The company also plans to expand its plasma collection operations, including opening a third center in San Antonio, TX, by the end of the first quarter of 2025. Each center in Houston and San Antonio is projected to contribute $8 million to $10 million annually in normal source plasma sales once at full capacity.
InnovAATe Clinical Trial Update
Kamada also announced an update to its pivotal Phase 3 InnovAATe clinical trial for inhaled Alpha-1 Antitrypsin (AAT) therapy. Following positive feedback from the U.S. FDA, the company intends to reduce the study sample size from 220 to approximately 180 patients. This decision is based on the FDA's agreement with a relaxed two-sided Type 1 error rate control change from 5% to 10% (p-value of 0.1). An interim futility analysis is planned by the end of 2025.
"Moreover, we are pleased to report that the U.S. FDA recently confirmed its agreement with our previously proposed relaxed two-sided Type 1 error rate control change from 5% to 10% (p-value of 0.1) for the ongoing pivotal Phase 3 InnovAATe clinical trial for our inhaled Alpha-1 Antitrypsin therapy. Based on the accepted change in the p-value, as well as additional expected revisions to the statistical analysis plan, we intend to reduce the study sample size from 220 patients to approximately 180 patients, while maintaining the statistical power of the trial, and conduct an interim futility analysis by the end of 2025,” concluded Mr. London.