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Kamada Announces FDA Approval of its Plasma Collection Center in Houston, Texas
Globenewswire· 2025-08-11 11:00
Core Insights - Kamada Ltd. has received FDA approval for its plasma collection center in Houston, Texas, allowing it to commence commercial sales of normal source plasma [1][2][3] - The Houston facility is expected to have an annual collection capacity of approximately 50,000 liters of plasma and generate estimated annual revenues of $8 million to $10 million at full capacity [2][6] - The company plans to seek approval from the European Medicines Agency (EMA) for the Houston center following the FDA approval [3][7] Company Overview - Kamada Ltd. is a global biopharmaceutical company focused on rare and serious conditions, with a portfolio that includes six FDA-approved specialty plasma-derived products [4] - The company's growth strategy includes organic growth from commercial activities, new business development, expansion of plasma collection operations, and advancing product candidates through R&D [4] - Kamada currently operates three plasma collection centers in Texas: Houston, San Antonio, and Beaumont, which collectively enhance its capacity for specialty and normal source plasma collection [3][4]
Kamada to Announce Second Quarter and First Half Ended June 30, 2025 Financial Results on August 13, 2025
Globenewswire· 2025-08-06 11:00
Company Overview - Kamada Ltd. is a global biopharmaceutical company focused on rare and serious conditions, specializing in specialty plasma-derived therapies [3] - The company has a portfolio of six FDA-approved specialty plasma-derived products, including KEDRAB®, CYTOGAM®, GLASSIA®, WINRHO SDF®, VARIZIG®, and HEPAGAM B® [3] - FIMI Opportunity Funds is the controlling shareholder, owning approximately 38% of the outstanding ordinary shares [3] Financial Results Announcement - Kamada will release its financial results for the second quarter and first half ended June 30, 2025, prior to the U.S. market opening on August 13, 2025 [1] - An investment community conference call will be held on August 13 at 8:30am ET to discuss the results and answer questions [2] Growth Strategy - The company aims for organic growth through commercialization and life cycle management of its proprietary products [3] - Kamada is pursuing new business development opportunities, including in-licensing, collaboration, and mergers and acquisitions to enhance its product portfolio [3] - The company is expanding plasma collection operations to support revenue growth and increasing demand for hyper-immune plasma [3] - Kamada is advancing the development of additional product candidates, with a focus on unmet medical needs, including the InnovAATe clinical trial for Inhaled AAT [3]
Kamada Confirms Continuous Global Business Operations and Products Availability Despite Recent Events in the Middle East
Globenewswire· 2025-06-17 11:00
Core Viewpoint - Kamada Ltd. continues its operations and manufacturing in Israel despite evolving circumstances in the Middle East, ensuring that the global availability of its products remains uninterrupted [1][2]. Company Overview - Kamada Ltd. is a global biopharmaceutical company specializing in products for rare and serious conditions, particularly in the specialty plasma-derived therapies field [3]. - The company has a portfolio of six FDA-approved specialty plasma-derived products, including KEDRAB®, CYTOGAM®, GLASSIA®, WINRHO SDF®, VARIZIG®, and HEPAGAM B®, along with other proprietary products and biosimilars [3]. - FIMI Opportunity Funds is the controlling shareholder, owning approximately 38% of the outstanding ordinary shares [3]. Business Continuity and Operations - The company is focused on business continuity and has sufficient product levels available through distribution centers outside Israel, despite temporary disruptions due to the closing of Israeli airspace [2][4]. - Kamada is actively monitoring the situation and prioritizing the well-being of its employees while ensuring that client demands are met without shortages [2][4]. Growth Strategy - Kamada's growth strategy is built on four pillars: organic growth through commercialization, securing new business development opportunities, expanding plasma collection operations, and advancing product candidates in development [3]. - The company operates three plasma collection centers in the United States to support revenue growth and meet increasing demand for hyper-immune plasma [3]. - The lead product candidate is Inhaled AAT, currently progressing through the InnovAATe clinical trial, a pivotal Phase 3 trial [3].
Kamada Reports Strong First Quarter 2025 Financial Results with Year Over Year Top Line Growth of 17% and a 54% Increase in Profitability
Globenewswire· 2025-05-14 11:00
Core Insights - Kamada Ltd. reported total revenues of $44.0 million for Q1 2025, marking a 17% increase year-over-year, driven by strong sales of GLASSIA® and KAMRAB® in international markets [2][6] - Adjusted EBITDA for the same period was $11.6 million, reflecting a 54% year-over-year increase, indicating effective management of operational expenses alongside revenue growth [2][6] - The company reiterated its full-year 2025 revenue guidance of $178 million to $182 million and adjusted EBITDA guidance of $38 million to $42 million, projecting continued profitable growth [2][9] Financial Performance - Revenues for Q1 2025 were $44.0 million, up from $37.7 million in Q1 2024, primarily due to increased sales in international markets [6] - Gross profit was $20.7 million with a gross margin of 47%, compared to $16.8 million and 44% in Q1 2024, attributed to a favorable product sales mix [6] - Operating expenses totaled $13.0 million, a slight increase from $12.7 million in Q1 2024, demonstrating the company's ability to manage costs effectively [6] Strategic Initiatives - The company is focusing on four strategic growth pillars: organic commercial growth, business development and M&A, plasma collection operations, and advancing the Phase 3 Inhaled AAT program [2][12] - Kamada opened a new plasma collection center in San Antonio, Texas, expected to generate annual revenues of $8 million to $10 million at full capacity [3][12] - A comprehensive post-marketing research program for CYTOGAM® has been initiated to support its use in managing cytomegalovirus (CMV) disease in organ transplantation [2][12] Balance Sheet Highlights - As of March 31, 2025, the company had cash and cash equivalents of $76.3 million, a slight decrease from $78.4 million at the end of 2024 [7] - Total assets increased to $375.1 million from $343.2 million at the end of 2024, reflecting growth in both current and non-current assets [17] - Current liabilities rose to $57.0 million from $37.2 million at the end of 2024, indicating increased operational activity [18] Market Outlook - The company anticipates a year-over-year revenue increase of approximately 12% and a 17% increase in adjusted EBITDA based on the midpoint of its 2025 guidance [9] - A three-year contract for the supply of KAMRAB and VARIZIG in Latin America is expected to generate approximately $25 million in total revenue, with a portion included in the 2025 revenue guidance [12]
Kamada to Announce First Quarter 2025 Financial Results on May 14, 2025
Globenewswire· 2025-05-07 11:00
Company Overview - Kamada Ltd. is a global biopharmaceutical company focused on rare and serious conditions, specializing in specialty plasma-derived therapies [3] - The company has a portfolio of six FDA-approved specialty plasma-derived products, including KEDRAB®, CYTOGAM®, GLASSIA®, WINRHO SDF®, VARIZIG®, and HEPAGAM B® [3] - FIMI Opportunity Funds is the controlling shareholder, owning approximately 38% of the outstanding ordinary shares [3] Financial Results Announcement - Kamada will release its financial results for the first quarter ending March 31, 2025, prior to the opening of U.S. financial markets on May 14, 2025 [1] - An investment community conference call will be held on the same day at 8:30am ET to discuss the results and answer questions [2] Growth Strategy - The company aims for organic growth through commercialization and life cycle management of its proprietary products [3] - Kamada is pursuing new business development opportunities, including in-licensing, collaboration, and M&A to enhance its product portfolio [3] - The company is expanding plasma collection operations to support revenue growth and meet increasing demand for hyper-immune plasma [3] - Kamada is advancing the development of additional product candidates, with a focus on unmet medical needs, including the InnovAATe clinical trial for Inhaled AAT [3]