Acorda Therapeutics(ACOR) - 2022 Q4 - Annual Report

Financial Performance - U.S. net revenue for Inbrija was $28.0 million for the year ended December 31, 2022[19]. - U.S. net revenue for Ampyra was $72.9 million for the year ended December 31, 2022[22]. - Net revenues for ex-U.S. Inbrija sales in Germany were $2.9 million for the year ended December 31, 2022[20]. - Ampyra U.S. net revenue was $72.9 million for the year ended December 31, 2022, reflecting a significant decline due to competition from generic versions[59]. - The arbitration panel awarded the company $15 million plus prejudgment interest of $1.5 million from Alkermes, with an additional $1.6 million awarded later, resulting in no further royalty payments to Alkermes for Ampyra[60]. Manufacturing and Supply Chain - The company incurred approximately $18.7 million of purchase commitments with Catalent for Inbrija in 2022[26]. - The new manufacturing services agreement with Catalent includes reduced minimum annual commitments of $10.5 million and $15.5 million for 2023 and 2024, respectively[28]. - The new spray drying equipment (PSD-7) is expected to be operational in 2026, significantly reducing per capsule fees[29]. - The company is obligated to pay a $4 million termination fee to Catalent, payable in April 2024[27]. - The company has secured alternative sources for the supply of Ampyra, which is expected to lower overall cost of goods sold[60]. - The company relies on Catalent for the supply of Inbrija components, exposing it to risks if suppliers discontinue their services[101]. - The company relies on a single third-party manufacturer for Inbrija inhalers, increasing the risk of supply issues that could harm commercialization efforts[103]. - An arbitration ruling in October 2022 allowed the company to cease royalty payments to Alkermes for Ampyra, enabling the use of alternative suppliers, with Patheon now serving as the sole manufacturer[104][105]. - The manufacturing services agreement with Patheon is automatically renewed annually unless either party provides a 12-month notice of non-renewal[106]. Market and Competition - Approximately 40% of people with Parkinson's in the U.S. experience OFF periods, indicating a significant market for Inbrija[19]. - The company faces significant competition in the market for Ampyra, leading to a substantial decline in sales since late 2018 due to generic competition[122][123]. - Fampyra, marketed outside the U.S. by Biogen, faces generic competition in Germany, which could adversely affect royalty revenue[61]. - The competitive landscape includes various therapies for neurological conditions, with many competitors having greater resources and experience[118]. Regulatory and Compliance - The FDA regulates both Ampyra and Inbrija, with specific requirements for preclinical testing and clinical development[127]. - The company cannot guarantee timely or commercially viable approval for any product under development[131]. - The FDA may require a Special Protocol Assessment (SPA) to agree on trial design and size before proceeding with Phase 3 trials, but this does not guarantee approval[135]. - The European Commission granted marketing authorization to Inbrija for treating episodic motor fluctuations in Parkinson's disease on September 19, 2019, valid throughout the EEA for five years[174]. - The marketing authorization holder for Inbrija must comply with EU pharmacovigilance rules and submit updated Risk Mitigation Plans (RMPs) as new information becomes available[178]. - Non-compliance with EU requirements can lead to significant financial penalties, including the potential suspension or revocation of marketing authorization[181]. Employee and Workplace - As of March 1, 2023, the company had 111 full-time and 11 temporary employees, along with approximately 25 sales representatives[204]. - The workforce composition included 48% female and 52% male employees, with 28% identifying as non-white[205]. - The company conducts annual pay equity analyses to ensure fair base pay structures regarding gender and race/ethnicity[205]. - Employee benefits include annual discretionary bonuses, equity awards, a 401(k) plan, and healthcare benefits[206]. - The company emphasizes a diverse, equitable, and inclusive workplace as a driver for growth[205]. - The company aims to provide a safe and rewarding workplace with opportunities for growth and career development[204]. - The company believes that competitive compensation and benefits are crucial for talent retention[206].