Kamada .(KMDA)2024-08-14 17:45Financial Data and Key Metrics Changes - Total revenue increased by 13% to 80.2 million compared to the prior year period [4][9] - Adjusted EBITDA for Q2 2024 was 16.6 million, up 68% over the prior year period [4][11] - Net income for Q2 2024 was 0.08 per diluted share, compared to 0.04 per share in Q2 2023 [10] Business Line Data and Key Metrics Changes - The growth in revenue was primarily driven by increased sales of KEDRAB and CYTOGAM due to higher demand in the U.S. market, with approximately 70% of revenues generated from the U.S. during the first half of 2024 [9][10] - Gross profit for Q2 2024 was 14.4 million or 39% margin in the prior year period [9][10] Market Data and Key Metrics Changes - The company reported strong performance in the U.S. market, with KEDRAB holding a market share of approximately 40% to 50% and expectations for further growth [20] - The company anticipates that biosimilars will significantly contribute to its distribution business in Israel, with potential annual sales between 34 million [6] Company Strategy and Development Direction - The growth strategy is built on four main pillars: organic growth of existing products, M&A transactions, opening plasma collection centers, and the ongoing Phase 3 trial of inhaled AAT targeting a 2 billion market [3][4] - The company is actively pursuing M&A opportunities to expand its commercial portfolio and support continued double-digit growth beyond 2024 [6][11] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving full-year 2024 revenue guidance of 158 million to 28 million to 56.6 million in cash, allowing for growth acceleration and business development opportunities [6][11] Other Important Information - The company is expanding its plasma collection capacity in the U.S., with new centers expected to contribute annual revenues between 10 million each [7] - The ongoing Phase 3 InnovAATe clinical trial for inhaled AAT therapy is progressing, with enrollment at approximately 40% to 45% [13] Q&A Session Summary Question: Inquiry about the inhaled AATD and FDA feedback - Management confirmed that they are awaiting FDA feedback on the revised statistical plan submitted and expect discussions to clarify the roadmap [12][13] Question: Enrollment status and competition - Enrollment is progressing, with challenges due to the nature of the study, but additional sites have been opened to facilitate recruitment [13] Question: AAT program commercialization partnerships - The focus is on finding partners primarily in the U.S. and Europe, with potential for one or two partners depending on the territory [16] Question: Business development opportunities - The focus is on commercial stage or near commercialization stage products, with an emphasis on supporting organic growth through M&A [17] Question: Potential for future dividends - While the company may consider dividends in the future, the current focus remains on M&A and business development [19] Question: Market share expectations for KEDRAB - KEDRAB is estimated to hold a market share of 40% to 50% in the U.S., with expectations for further growth [20]