Financial Data and Key Metrics Changes - Total revenues for the first nine months of 2025 were $135.8 million, representing an 11% year-over-year increase [4][10] - Adjusted EBITDA was $34.2 million, up 35% year-over-year, with a 25% margin on revenues [4] - Net income for the first nine months of 2025 was $16.6 million, or $0.29 per diluted share, up 56% compared to the first nine months of 2024 [12] Business Line Data and Key Metrics Changes - Revenue growth was primarily driven by increased sales of Glassia in ex-U.S. markets, particularly in Latin America and the CIS region [5] - The anti-CMV immunoglobulin Cytogam is undergoing a comprehensive post-marketing research program to demonstrate its advantages [6][31] - The company launched its first biosimilar product in Israel, expected to generate approximately $2.5 million in revenues in 2025, with plans for two additional biosimilars [7] Market Data and Key Metrics Changes - The company has a significant market share in the U.S. for its anti-rabies immunoglobulin Kamrab, with a firm commitment for minimum orders through 2027 [4] - Sales of Cytogam have been below expectations due to inventory management and fewer transplants performed in some hospitals [33] Company Strategy and Development Direction - The company is guided by a four-pillar growth strategy, including organic commercial growth, business development, M&A transactions, plasma collection operations, and advancing its inhaled AAT program [4][39] - Active due diligence is being conducted over several potential commercial targets, with expectations to secure transactions in early 2026 [8][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continuing to generate profitable growth through the remainder of 2025, reiterating annual revenue guidance of $178 million-$182 million [4] - The company is addressing challenges in the Cytogam market and expects resumed growth in the coming months [33] Other Important Information - The Houston plasma collection facility has received FDA approval, with expectations for the San Antonio site to follow in early 2026 [9] - Each plasma collection center is expected to generate annual revenues of $8 million-$10 million at full capacity [9] Q&A Session Summary Question: Details on the Cytogam study and its differences from previous clinical data - The SHILD study will test Cytogam's use in late CMV after antiviral treatment, differing from its current prophylactic use [15][16] Question: Enrollment status for the ATD treatment - Enrollment is at 60-65%, with completion expected by early 2027 and top-line results anticipated in H1 2029 [18][20] Question: Performance of the distribution business - The distribution business has seen actual usage growth, with expectations for continued growth due to a richer product portfolio [24] Question: Plasma collection relative to proprietary product needs - Currently, the majority of plasma collected is normal source plasma, with plans to increase specialty plasma collection over time [25][26] Question: Interim data release for the ATD treatment clinical trial - Results from the interim analysis will be shared through a press release before the end of the year [27][28] Question: Performance of Cytogam and growth drivers - Cytogam sales have been below plan due to inventory management and fewer transplants, but growth is expected to resume [31][33] Question: Future of Glassia royalties - Royalties from Glassia are expected to be above $10 million in 2026, with single-digit growth anticipated thereafter [34][35] Question: Current business development activities - The company is conducting thorough due diligence for potential transactions, with expectations for successful integration of new assets [36][37]
Kamada .(KMDA) - 2025 Q3 - Earnings Call Transcript