Kamada .(KMDA) - 2024 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported total revenues of $37.7 million for Q1 2024, representing a year-over-year growth of 23$30.7 million in Q1 2023 [5][11] - Adjusted EBITDA for Q1 2024 was $7.5 million, a 96$2.3 million or $0.04 per diluted share, compared to a net loss of$1.8 million or a loss of $0.04 per share in Q1 2023 [27] Business Line Data and Key Metrics Changes - The growth in revenues was primarily driven by increased sales of KEDRAB and CYTOGAM due to heightened demand in the US market [11][21] - Operating expenses totaled$12.7 million, an increase of approximately 9% over the prior year, aligned with expectations to support expanded commercial activities and the Phase 3 InnovAATe trial [12] Market Data and Key Metrics Changes - Nearly 70% of revenues in Q1 2024 were generated from the US market [26] - The company successfully launched BEVACIZUMAB KAMADA, a biosimilar to Avastin, in Israel, which is expected to contribute to revenue growth [22] Company Strategy and Development Direction - The company is focusing on expanding its biosimilar portfolio, with expectations of significant contributions to revenue from these products in the coming years [8][15] - The company is actively pursuing business development opportunities to add commercial products to its portfolio, which is anticipated to support growth beyond 2024 [7][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued momentum throughout 2024, raising full-year revenue guidance to between $158 million and$162 million and adjusted EBITDA guidance to between $28 million and$32 million [19][27] - The company is encouraged by the positive feedback from the FDA regarding its inhaled Alpha-1 Antitrypsin therapy program, which may lead to accelerated development [9][23] Other Important Information - The company ended Q1 2024 with approximately 48 million in cash, providing financial strength for growth and development opportunities [7] - The company is expanding its plasma collection capacity, with new centers being established in Texas [10] Q&A Session Summary Question: What is the main driver of the revenue increase? - The main driver for the revenue increase has been primarily CYTOGAM, with a successful relaunch and increased physician awareness contributing to growth [29] Question: Can you provide details on the biosimilar program? - The current biosimilar portfolio is expected to generate between 32 million to $36 million in revenues, with each product contributing$2 million to $4 million over time [15] Question: What are the dynamics of biosimilars in Israel? - The dynamics in Israel are similar to those in the US, with market share dependent on the timing of product approvals and the company's first-mover advantage [43] Question: What areas is the company pursuing for business development? - The company is evaluating multiple opportunities in plasma-derived and transplantation products, looking for commercial-stage products to fuel growth [44] Question: Can you elaborate on the revised statistical analysis plan for the inhaled AAT program? - The revised plan, based on positive FDA feedback, aims to reduce sample size requirements and has been submitted for review, with expected feedback in the second half of the year [47]