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Manufacturing and Operations - The company operates manufacturing facilities for clinical supplies of injectable extended-release products and solid dosage forms in Wilmington, Ohio, and Athlone, Ireland[63][64]. - The company must adhere to Good Manufacturing Practices (cGMP) and is subject to inspections that could lead to sanctions if non-compliance is found[108]. Research and Development - Significant resources are devoted to R&D programs focusing on novel therapeutics in areas of high unmet medical need, including pharmaceutical formulation and drug optimization[63]. - The company has a proprietary portfolio of patent rights, including numerous patents in the U.S. and other countries, with plans to file additional patent applications for new or improved products[78]. Sales and Marketing - The sales force for VIVITROL in the U.S. consists of approximately 115 individuals, with major wholesalers accounting for 27% (Cardinal Health), 23% (McKesson Corporation), and 16% (AmerisourceBergen) of total gross sales[67]. - The sales force for ARISTADA, ARISTADA INITIO, and LYBALVI in the U.S. consists of approximately 360 individuals, with Cardinal Health, AmerisourceBergen, and McKesson Corporation representing 46%, 24%, and 23% of total gross sales for ARISTADA and ARISTADA INITIO, and 36%, 31%, and 29% for LYBALVI, respectively[68]. - The company is subject to various laws regulating sales and marketing practices, with potential penalties for violations impacting business operations[114]. Competition - The company faces intense competition from various biopharmaceutical companies and research institutions, with competitors potentially having greater financial resources[70][71]. - In the treatment of schizophrenia, ARISTADA competes with several other injectable products, including INVEGA and RISPERDAL CONSTA, as well as other formulations from companies like Teva and Otsuka[72]. - In the treatment of alcohol dependence, VIVITROL competes with generic drugs and other marketed products, with ongoing development of new treatments by other pharmaceutical companies[74]. Intellectual Property - The company owns one unexpired U.S. patent covering VIVITROL, which expires in 2029, and has granted Teva a license to market a generic version starting January 15, 2027[82]. - The NanoCrystal technology patent portfolio licensed to Janssen includes patents expiring in 2030 in the U.S. and other regions, with additional patents covering INVEGA SUSTENNA expiring in 2031, INVEGA TRINZA in 2036, and INVEGA HAFYERA in 2041[83]. - U.S. patents covering VUMERITY are set to expire in 2033, with ongoing legal proceedings related to these patents[84]. - The principal U.S. patents for LYBALVI have expiration dates ranging from 2025 to 2041, with multiple patents expiring in 2031[86]. - The company has U.S. patent protection for ALKS 2680 extending to 2041, along with several pending applications[87]. - The company relies on trade secrets and know-how, which are not protected by patents, to maintain its competitive position[92]. Regulatory Compliance - The FDA has a standard review process of 10 months for NDA submissions, with potential for expedited review under certain conditions[99]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) to ensure the benefits of a new product outweigh its risks[100]. - Non-compliance with safety reporting requirements can lead to civil or criminal penalties, impacting the company's ability to market products[102]. - The FDA requires prior review and approval for changes to approved products, which can delay or increase costs significantly[103]. - The company must comply with stringent FDA regulations regarding advertising and promotional activities, with potential penalties for non-compliance[104]. - The DEA regulates controlled substances, and any classification as such may delay commercial launch despite FDA approval[105]. - In Europe, the centralized procedure for marketing approval involves a single application to the EMA, which, if approved, is valid across all EU member states[106]. - Good Clinical Practices (GCP) are enforced by regulatory agencies to ensure the accuracy of clinical trial data, with non-compliance potentially leading to additional trials or sanctions[109]. - The Hatch-Waxman Act provides five years of marketing exclusivity for new chemical entities, preventing generic applications during this period[110]. - Orphan Drug Exclusivity (ODE) can be granted for drugs treating rare diseases, blocking FDA approval of similar applications for seven years[114]. Financial and Market Risks - Medicaid rebates are calculated as the greater of 23.1% of average manufacturer price or the difference between AMP and the best price, impacting revenue generation[116]. - Medicare Part B pays for drugs based on average sales price (ASP) plus a specified percentage, with manufacturers required to report ASP quarterly[118]. - Medicare Part D mandates a 70% discount on brand name prescription drugs for beneficiaries reaching the coverage gap[119]. - The 340B program requires manufacturers to charge covered entities no more than the 340B ceiling price, calculated using a statutory formula based on average manufacturer price[120]. - FSS pricing for federal agencies is capped at 76% of the non-federal average manufacturer price (non-FAMP), with additional discounts if non-FAMP increases beyond inflation[121]. - The Inflation Reduction Act of 2022 introduces new financial liabilities for manufacturers in Medicare Part D starting in 2025 and allows government price negotiations beginning in 2026[124]. - In the EU, governments influence reimbursement and pricing, with potential cost-containment measures including price cuts and mandatory rebates[125]. Workforce and Culture - The company had approximately 2,100 full-time employees as of February 9, 2024, with a voluntary attrition rate of 9.5%[132]. - The company is committed to diversity, inclusion, and belonging (DIB), with initiatives including Employee Resource Groups and annual performance goals for senior leaders[136]. - The company has implemented employee engagement surveys since 2017 to assess and improve employee satisfaction and sentiment[138]. - The company maintains a focus on employee health, safety, and wellness, particularly in the context of a hybrid work model adopted in 2023[140]. - The company has established a women's mentoring program to support the development of female talent within its workforce[137]. Cybersecurity and Compliance Risks - The company has not experienced any material cybersecurity incidents to date, but acknowledges the increasing risks associated with IT system breaches[208]. - The company is subject to evolving privacy and data protection laws, including GDPR, which could lead to significant penalties if not complied with[209]. Market Performance and Shareholder Relations - The market price of the company's ordinary shares fluctuated between $23.37 and $33.63 during the year ended December 31, 2023[204]. - The company has experienced significant volatility in its stock price due to business performance and regulatory actions, impacting its market valuation[204]. - The company has engaged in extensive dialogue with activist shareholders, resulting in contested elections and potential disruptions to its strategic direction[205]. Internal Control and Compliance - The company faces risks related to material weaknesses in internal control over financial reporting, which could negatively impact the trading price of its ordinary shares[211]. - Annual reporting on internal control effectiveness is mandated by the Sarbanes-Oxley Act of 2002, and any identified deficiencies could adversely affect business and financial results[212]. - Lack of effective internal control could lead to a decline in investor confidence and trading price of ordinary shares, as well as potential sanctions from regulatory authorities[213]. Social Media Risks - The increasing use of social media for corporate communication presents risks of regulatory violations and potential legal claims related to off-label marketing[214]. - Employees' non-compliance with social media policies could result in liability, loss of trade secrets, and public disclosure of sensitive information[215]. - Negative social media posts could damage the company's reputation, brand image, and goodwill, leading to potential regulatory actions[215].

Fourth Quarter and Year-End 2023 Financial Results & Business Update Forward-Looking Statements Certain statements set forth in this presentation constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: Alkermes plc’s (the “Company”) expectations with respect to its current and future financial and operating performance, business plans or prospects, including its expected cash generat ...

Alkermes plc (NASDAQ:ALKS) Q4 2023 Earnings Conference Call February 15, 2024 8:00 AM ET Company Participants Sandra Coombs - Senior Vice President, Corporate Affairs and Investor Relations Richard Pops - Chairman and Chief Executive Officer Todd Nichols - Senior Vice President and Chief Commercial Officer Blair Jackson - Executive Vice President and Chief Operating Officer Conference Call Participants David Amsellem - Piper Sandler Akash Tiwari - Jefferies Paul Matteis - Stifel Jason Gerberry - Bank of Ame ...

Alkermes plc (ALKS) reported fourth-quarter 2023 adjusted earnings of 48 cents per share, which beat the Zacks Consensus Estimate of 46 cents. The company had reported adjusted earnings of 40 cents per share in the year-ago quarter.ALKS’ revenues of $377.5 million surged almost 24% from the year-ago quarter’s level owing to strong performance of its proprietary products portfolio. The top line also beat the Zacks Consensus Estimate of $361.2 million.Quarter in DetailALKS derives revenues on net sales of its ...

For the quarter ended December 2023, Alkermes (ALKS) reported revenue of $377.48 million, up 23.9% over the same period last year. EPS came in at $0.48, compared to $0.14 in the year-ago quarter.The reported revenue represents a surprise of +4.50% over the Zacks Consensus Estimate of $361.24 million. With the consensus EPS estimate being $0.46, the EPS surprise was +4.35%.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street e ...

DUBLIN, Feb. 8, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. GMT) on Thursday, Feb. 15, 2024 to discuss the company's fourth quarter and year-end 2023 financial results. Management will also discuss financial expectations for 2024 and provide an update on the company. The webcast player and accompanying slides may be accessed on the Investors section of Alkermes' website at www.alkermes.com. The conference call may be access ...

Wall Street expects a year-over-year increase in earnings on higher revenues when Alkermes (ALKS) reports results for the quarter ended December 2023. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock m ...