Kamada .(US:KMDA)2023-08-16 19:53Financial Data and Key Metrics Changes - Total revenues for Q2 2023 were approximately $37.4 million, representing a 59% increase year-over-year, while total revenues for the first six months of 2023 were $68.2 million, reflecting a 32% increase [3][19] - Adjusted EBITDA for the first half of 2023 was $9.5 million, a 24% increase compared to the same period in 2022 [10][19] - Net income for Q2 2023 was approximately $1.8 million or $0.04 per share, compared to a net loss of $3.9 million or a loss of $0.09 per share in the prior year period [28] Business Line Data and Key Metrics Changes - Significant increase in KEDRAB sales to Kedrion for further distribution in the U.S., with sales in 2022 generating approximately $16 million and an anticipated total U.S. market of $150 million annually [22][69] - Total gross profit for Q2 2023 was $14.4 million, representing a 39% margin, compared to $7.2 million or 31% margin in Q2 2022 [47] - Operating expenses totaled $11.8 million in Q2 2023, an increase from $9.5 million in Q2 2022, with expectations of a 15% to 20% increase in overall operating expenditures for 2023 compared to 2022 [48] Market Data and Key Metrics Changes - The U.S. market for KEDRAB is experiencing increased demand, with expectations for continued growth into 2024 and 2025 [69] - The company is expanding its plasma collection capacity in the U.S., with plans to open a second collection center in Houston, Texas, in early 2024 [24] Company Strategy and Development Direction - The company is focused on leveraging its growth drivers, including KEDRAB sales and FDA-approved hemoglobins, while pursuing business development opportunities [8][41] - The company aims to become a fully integrated specialty plasma product company, supported by its acquisition of a plasma collection center in Beaumont, Texas [24] Management's Comments on Operating Environment and Future Outlook - Management reiterated full-year 2023 revenue guidance of $138 million to $146 million and adjusted EBITDA guidance of $22 million to $26 million, indicating a 35% growth compared to fiscal year 2022 [10][40] - Positive feedback from U.S. physicians is expected to contribute to continued growth in demand for the company's products [23] Other Important Information - The company is set to hold an extraordinary general meeting on August 29, 2023, to approve a private placement with FIMI, which will provide financial flexibility for growth [21] - The company has received FDA approval to manufacture CYTOGAM at its Israeli facility, ensuring continued supply to the U.S. and Canadian markets [44] Q&A Session Summary Question: Can you talk about the potential preclinical programs that you might be moving forward or priorities that you're focused on? - The company is focusing on the Alpha-1 pivotal Phase III study and has three early-stage preclinical programs ongoing, including plasma eye drops development and immune globulin for TB [12][34] Question: Can you describe the market dynamics that are driving increased demand in the U.S. for KEDRAB? - The company is experiencing significant demand increases due to effective marketing efforts and a differentiated product with pediatric indications, leading to market share expansion [13][69] Question: Is there an opportunity to shorten the regulatory pathway in Europe for Inhaled AAT? - The EMA confirmed support for the current study design and does not support acceleration through a reduction in sample size, maintaining the planned enrollment of 220 patients [58]