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Appili Therapeutics Reports Fiscal Year 2025 Financial and Operational Results
Globenewswire· 2025-06-25 22:04
Core Viewpoint - Appili Therapeutics has successfully re-launched LIKMEZ™ (ATI-1501), a metronidazole oral suspension, and is actively pursuing funding opportunities to support its development programs and enhance its market position [2][3][14]. Group 1: Product Development and Market Position - LIKMEZ™ (ATI-1501) is the first FDA-approved, ready-to-use liquid oral suspension of metronidazole, specifically designed for patients who have difficulty swallowing tablets or are sensitive to taste [3][4]. - The re-launch of LIKMEZ follows new patent coverage extending to 2039, marking a significant milestone for the company and its partner, Saptalis Pharmaceuticals [2]. - Appili is focused on driving continued sales of LIKMEZ while advancing other product candidates, including ATI-1701 and ATI-1801 [3]. Group 2: Funding and Financial Performance - The company has submitted five non-dilutive funding proposals to the U.S. government, with a total potential value of up to US$125 million, aimed at supporting the development of critical infectious disease products [3][14]. - For the fiscal year ended March 31, 2025, Appili reported a net loss of CAD 2.6 million, which is an improvement from a net loss of CAD 3.8 million in the previous year, primarily due to increased government assistance and other income [19][20]. - As of March 31, 2025, the company had cash reserves of CAD 1.2 million, a significant increase from CAD 0.1 million a year earlier, indicating improved liquidity [21]. Group 3: Research and Development Progress - ATI-1701, a biodefense vaccine candidate for tularemia, has received approximately US$11.6 million in funding from the U.S. Air Force Academy and has shown promising results in providing protection against lethal tularemia [5][6]. - The company is actively pursuing additional funding and partnership opportunities for ATI-1801, a topical antiparasitic product that has received Orphan Drug Designation from the FDA [10][13]. - Appili has successfully completed technology transfer for the ATI-1701 manufacturing process, supporting future development activities [8].
Emergent BioSolutions (EBS) 2025 Conference Transcript
2025-05-20 20:35
Emergent BioSolutions (EBS) Conference Summary Company Overview - Emergent BioSolutions is a biopharma company with a focus on biodefense and medical countermeasures, established for over 25 years [2][3] - The company produces critical products for the U.S. Government and allied nations, including vaccines and therapeutics for smallpox, anthrax, Ebola, and botulism [3][4][22] Core Products and Market Position - Key products include: - Tymbexa (smallpox vaccine) - Sifendis (anthrax vaccine) - BioThrax (anthrax treatment) - Ibanga (Ebola treatment) - Narcan (opioid overdose reversal) [21][22][30] - Narcan is the largest product, with a market share of approximately 70-75% in the naloxone category [37] Financial Performance and Strategic Plan - Emergent aims for revenue between $750 million to $850 million and adjusted EBITDA of $150 million to $200 million for fiscal 2025 [43] - Adjusted EBITDA improved from negative in 2023 to $183 million in 2024, indicating a successful stabilization phase [14][43] - The company is currently in a turnaround phase, focusing on investments in R&D and business development to drive growth [15][41] Challenges and Opportunities - The company faced significant debt issues, which have been addressed through debt reduction and maturity extensions [9][12] - Emergent is working to enhance the accessibility of Narcan, aiming to include it in first aid kits and increase distribution through partnerships with retailers and e-commerce platforms [30][34][36] Regulatory and Market Environment - Emergent benefits from bipartisan support for biodefense initiatives, which is crucial for securing government contracts [20] - The company manufactures products in the U.S. and Canada, minimizing the impact of tariffs and aligning with reshoring trends in the pharmaceutical industry [48][50] Future Aspirations - The long-term goal is to transform Emergent into a sustainable growth company, with a focus on reducing opioid overdose deaths and expanding international market presence [57][58] - The company aims to leverage its CDMO capabilities to assist other pharmaceutical companies in bringing manufacturing back to the U.S. [51][53] Conclusion - Emergent BioSolutions is positioned to play a critical role in public health through its innovative products and strategic initiatives aimed at addressing pressing health threats, particularly in the context of opioid overdoses and biodefense [36][57]
SIGA Reports Financial Results for Three Months Ended March 31, 2025
Globenewswire· 2025-05-08 20:05
Received $26 Million IV TPOXX Procurement Order from the U.S. Government in March$94 million in TPOXX Orders (to be Delivered to U.S. Strategic National Stockpile) outstanding as of March 31, 2025Corporate Update Conference Call Today at 4:30 PM ET NEW YORK, May 08, 2025 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (Nasdaq: SIGA), a commercial-stage pharmaceutical company, today reported financial results for the three months ended March 31, 2025. “SIGA has carried its momentum from 2024 into 2025, ac ...
Emergent BioSolutions(EBS) - 2024 Q4 - Earnings Call Transcript
2025-03-04 00:58
Emergent BioSolutions Inc. (NYSE:EBS) Q4 2024 Earnings Conference Call March 3, 2025 6:00 AM ET Company Participants Frank Vargo - Assistant Treasurer Joseph Papa - President and Chief Executive Officer Richard Lindahl - Executive Vice President, Chief Financial Officer and Treasurer Conference Call Participants Nick Richitt - JPMorgan Brandon Folkes - Rodman & Renshaw Operator Good day, and thank you for standing by. Welcome to Emergent BioSolutions Inc. Fourth Quarter 2024 Earnings Conference Call. At thi ...