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Kamada Announces a $10-$14 Million Extension of Canadian Supply Tender
Globenewswire· 2025-12-18 12:00
Company Awarded Extension to Existing Supply Tender Relating to its Portfolio of Four Specialty Plasma-Derived ProductsSupply Extension Secures Ongoing Sales of Approximately $5.0-$7.0 Million Per Year for the Period Between Q2-26 and Q1-28Kamada Reiterates its 2025 Full-Year Revenue Guidance of $178 Million-$182 Million and Adjusted EBITDA of $40 Million-$44 MillionKamada Projects Double-Digit Growth in Revenues and Profitability in 2026; Detailed Guidance to be Provided in January 2026 REHOVOT, Israel, an ...
Kamada Announces Discontinuation of its Phase 3 Inhaled AAT Clinical Trial; Reiterates 2025 Full-Year Guidance and Projects Double-Digit Growth in Revenues and Profitability in 2026
Globenewswire· 2025-12-08 12:00
Core Insights - Kamada Ltd. announced the discontinuation of the Phase 3 InnovAATe trial for Inhaled AAT due to an interim futility analysis indicating low likelihood of achieving statistically significant benefits in lung function [1][5] - The company remains committed to supporting the Alpha-1 Antitrypsin Deficiency (AATD) community through its existing product GLASSIA and is focused on future growth prospects despite the trial's outcome [2][5] Financial Guidance - Kamada reiterated its full-year 2025 revenue guidance of $178 million to $182 million and adjusted EBITDA guidance of $40 million to $44 million [2][5] - The company projects double-digit growth in revenues and profitability for 2026, with detailed guidance to be provided in January 2026 [2][5] Business Strategy - Kamada's growth strategy includes organic growth from its commercial activities, business development opportunities, and expansion of plasma collection operations [4][6] - The company currently operates three plasma collection centers in the U.S. and aims to enhance its marketed products portfolio through potential collaborations and acquisitions [4][6] Company Overview - Kamada is a global biopharmaceutical company specializing in products for rare and serious conditions, particularly in the specialty plasma-derived therapies field [4][6] - The company is controlled by FIMI Opportunity Funds, which owns approximately 38% of its outstanding shares [6]
Kamada Reports Strong Third Quarter and Nine Month 2025 Financial Results with over 30% Year-over-Year Profitability Growth
Globenewswire· 2025-11-10 12:00
Core Insights - Kamada Ltd. reported strong financial results for the third quarter and the first nine months of 2025, with total revenues of $135.8 million, an 11% year-over-year increase, and adjusted EBITDA of $34.2 million, up 35% year-over-year [2][6][11]. Financial Performance - Third quarter revenues reached $47.0 million, a 13% increase from $41.7 million in the same quarter of 2024 [6][7]. - Gross profit for the third quarter was $19.8 million, with a gross margin of 42%, compared to $17.2 million and 41% in the prior year [7]. - For the first nine months of 2025, gross profit was $59.4 million, with a gross margin of 44%, up from $52.9 million and 43% in the same period of 2024 [11][12]. - Net income for the first nine months was $16.6 million, or $0.29 per diluted share, a 56% increase from $10.7 million, or $0.18 per diluted share, in the same period of 2024 [11][12]. Operational Highlights - The company generated $17.9 million in cash from operating activities during the first nine months of 2025, contributing to a cash position of $72.0 million as of September 30, 2025 [2][9]. - Kamada continues to invest in plasma collection operations, recently receiving FDA approval for its Houston facility, which is expected to be one of the largest collection centers for specialty plasma in the U.S. [4][12]. - The company is advancing its pivotal Phase 3 InnovAATe clinical trial for inhaled Alpha-1 Antitrypsin therapy, with an interim futility analysis expected by the end of 2025 [4][11]. Strategic Initiatives - Kamada is focused on expanding its product portfolio and securing long-term sales agreements for normal source plasma [4][12]. - The company has launched a comprehensive post-marketing research program for CYTOGAM® to support its benefits in managing cytomegalovirus (CMV) in solid organ transplantation [3][12]. - The company reiterated its full-year 2025 revenue guidance of $178 million to $182 million and adjusted EBITDA guidance of $40 million to $44 million, indicating a positive outlook for the remainder of the year [2][11].
Kamada to Announce Third Quarter and Nine Months Ended September 30, 2025 Financial Results on November 10, 2025
Globenewswire· 2025-11-03 12:00
Core Insights - Kamada Ltd. will release its financial results for Q3 and the nine months ending September 30, 2025, on November 10, 2025, before U.S. market opening [1] - An investment community conference call will be held on the same day at 8:30 AM ET to discuss the results and answer questions [2] Company Overview - Kamada Ltd. is a global biopharmaceutical company focused on rare and serious conditions, specializing in plasma-derived therapies [3] - The company has a portfolio of six FDA-approved specialty plasma-derived products and is expanding its product offerings through biosimilars and new business development opportunities [3] - Kamada operates three plasma collection centers in Texas, supporting revenue growth through the sale of normal source plasma and hyper-immune plasma [3] - The company is advancing its lead product candidate, Inhaled AAT, through the InnovAATe clinical trial, a pivotal Phase 3 trial [3] - FIMI Opportunity Funds is the controlling shareholder, owning approximately 38% of the outstanding ordinary shares [3]
Kamada to Present at the Stifel 2025 Healthcare Conference
Globenewswire· 2025-10-29 11:00
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 [3] Growth Strategy - Kamada's growth strategy is built on four primary pillars: 1. Organic growth through commercialization and life cycle management of proprietary products [3] 2. Securing new business development opportunities, including in-licensing, collaborations, and mergers and acquisitions to enhance its product portfolio [3] 3. Expanding plasma collection operations to support revenue growth and meet increasing demand for hyper-immune plasma [3] 4. Advancing the development and commercialization of additional product candidates, with a focus on unmet medical needs, such as the Inhaled AAT product candidate currently in a pivotal Phase 3 trial [3] Leadership and Events - Amir London, the CEO of Kamada, will present at the Stifel 2025 Healthcare Conference on November 12, 2025, and will be available for one-on-one investor meetings [2]
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]