A younger Jazz Pharmaceuticals, specializing in treatments for narcolepsy and other rare neurological conditions.

Like a Sarepta Therapeutics, but focused on rare neurological disorders instead of muscular dystrophies.

• Wakix (pitolisant): An oral medication approved to treat excessive daytime sleepiness (EDS) and cataplexy in adult patients with narcolepsy.

• Cencora (formerly AmerisourceBergen) (Symbol: NYSE: ABC)
• McKesson Corporation (Symbol: NYSE: MCK)
• Cardinal Health (Symbol: NYSE: CAH)

• Bioprojet SCR
• Fareva Amboise

Jeffrey M. Dayno, M.D., President and Chief Executive Officer

Dr. Jeffrey M. Dayno is the President and Chief Executive Officer of Harmony Biosciences, having been appointed to the role in January 2023. He previously served as the Interim President and CEO since January 2023, and as Chief Medical Officer and Executive Vice President since the company's founding in 2017. A nationally recognized expert in neuroscience, Dr. Dayno is responsible for overseeing Harmony's business growth, which includes the acquisitions of Zynerba Pharmaceuticals in 2023 and Epygenix Therapeutics, Inc. in 2024. He played a critical role in the FDA approval of Harmony's key asset, WAKIX (pitolisant), and helped shape the company's commercial strategy. Before joining Harmony, Dr. Dayno spent 10 years in clinical and academic medicine as a neurologist, followed by over 25 years in the pharmaceutical industry, holding leadership roles at companies such as Merck & Co., Cephalon, and ViroPharma. Harmony Biosciences was established by Paragon Biosciences, LLC, a global life science leader that creates, builds, and funds innovative biology-based companies.

Sandip Kapadia, CPA, MBA, Chief Financial Officer and Chief Administrative Officer

Sandip Kapadia serves as the Chief Financial Officer and Chief Administrative Officer for Harmony Biosciences. He brings over 25 years of experience in the life sciences industry, providing strategic financial oversight and guidance to companies in both the United States and Europe. Most recently, Mr. Kapadia was the Chief Financial Officer at Intercept Pharmaceuticals, Inc. from July 2016 to March 2021, where he significantly contributed to building key functional capabilities, developing and executing financial and capital strategies for commercial launch, and raising over $700 million in various financings. Prior to Intercept, he spent the majority of his career at Novartis and its affiliates, holding various positions, including Chief Financial Officer of North America at Sandoz, Novartis's generic division. Mr. Kapadia is a Certified Public Accountant and holds an MBA from Rutgers University. He currently serves on the board of directors of Passage Bio, Inc., Molecular Partners AG, and VectivBio Holding AG.

Kumar Budur, MD, MS, Chief Medical and Scientific Officer

Dr. Kumar Budur is the Chief Medical and Scientific Officer at Harmony Biosciences. In this role, he leads the company's Research and Development (R&D) strategy and Medical Affairs, overseeing areas such as Clinical Strategy, Clinical Operations, Regulatory Affairs, Pharmacovigilance, Biostatistics, Portfolio Management, and Medical Affairs. Before joining Harmony Biosciences, Dr. Budur held positions of increasing responsibility for approximately six years at both AbbVie and Takeda. He is recognized as an expert in R&D, having overseen programs from late discovery to post-marketing studies and having experience with small molecules, biologics, and drug-device combinations. Dr. Budur was involved with four New Drug Applications (NDAs) and was the lead for the registration clinical trials, submission, and approval process of two NDAs.

Adam Zaeske, MBA, Executive Vice President and Chief Commercial Officer

Adam Zaeske serves as the Executive Vice President and Chief Commercial Officer at Harmony Biosciences. He has over 25 years of experience in building teams and transforming organizations across the US and Europe. His background encompasses a broad range of functions, including marketing, sales, market access, new product planning, and finance. Mr. Zaeske has successfully led and launched products in more than a dozen therapeutic areas, including orphan and cell & gene therapies. Before joining Harmony, he was the Head of Central, South and East Europe for Takeda Pharmaceuticals, where he led a region with over $2 billion USD in revenue and nearly 900 employees. He also previously served as Takeda's Head of Portfolio & Pipeline.

Andrew Serafin, JD, MBA, Chief Strategy Officer

Andrew Serafin is the Chief Strategy Officer at Harmony Biosciences. He is responsible for guiding the company's corporate strategy, business and corporate development initiatives, and alliance management efforts. This includes expanding Harmony's pipeline through the acquisition and licensing of novel rare disease therapies. Mr. Serafin brings 20 years of experience in mergers and acquisitions and corporate legal counseling within the pharmaceutical, broader healthcare, and technology sectors. He holds a Bachelor of Science degree from the University of Illinois, a Juris Doctor from the Loyola University Chicago School of Law, and a Master of Business Administration from the Northwestern University Kellogg School of Management.

The primary business risks for Harmony Biosciences (HRMY) revolve around its reliance on its flagship product, market competition, and the inherent challenges of pharmaceutical development.

1. High Dependence on WAKIX (Pitolisant): Harmony Biosciences is substantially dependent on the commercial success of WAKIX (pitolisant), which currently serves as its primary revenue source. Any factors leading to a decline in WAKIX sales, such as increased competition, unexpected safety issues, or failure to secure approval for new indications, could significantly impact the company's financial performance and revenue generation.
2. Intense Market Competition: Harmony Biosciences operates in a highly competitive biopharmaceutical sector, particularly within the narcolepsy treatment market. The company faces ongoing competition from established pharmaceutical companies like Jazz Pharmaceuticals and Avadel Pharmaceuticals, as well as from emerging innovative therapies, including new orexin receptor 2 agonists under development by companies such as Alkermes and Takeda. The potential emergence of generic alternatives to existing treatments also poses a competitive threat. This competitive landscape could pressure WAKIX's market share and pricing.
3. Clinical Trial Failures and Regulatory Setbacks: Harmony Biosciences' future growth and diversification heavily rely on the successful development and regulatory approval of pipeline assets and new indications for WAKIX. The company has experienced setbacks, including the failure of a Phase 3 study for ZYN002 in Fragile X syndrome and a Refusal to File letter from the FDA for a supplemental New Drug Application for pitolisant in idiopathic hypersomnia. Such failures and delays in clinical trials or regulatory processes can hinder product diversification, delay market entry, and negatively affect future revenue potential and investor confidence.

The clear emerging threat for Harmony Biosciences is the potential market entry of Axsome Therapeutics' AXS-12.

AXS-12 is an investigational drug for the treatment of narcolepsy, directly targeting the same indication as Harmony Biosciences' primary product, WAKIX (pitolisant). Axsome Therapeutics is currently conducting a Phase 3 trial (SYMPHONY) for AXS-12, with topline results expected in the second half of 2024. If successful, AXS-12 could offer a new treatment option for narcolepsy, potentially with a different efficacy or safety profile, which could compete directly for market share with WAKIX.

WAKIX® (pitolisant)

• U.S. Narcolepsy Therapeutics Market: The U.S. narcolepsy therapeutics market was valued at approximately $1.186 billion in 2023 and is projected to reach around $1.867 billion by 2030. Another estimate places the U.S. narcolepsy therapeutics market at $1.018 billion in 2024, growing to approximately $2.166 billion by 2034. The market opportunity for diagnosed narcolepsy patients in the U.S. is approximately 80,000 individuals.

• Global Idiopathic Hypersomnia Treatment Market: The global idiopathic hypersomnia treatment market reached $1.5 billion in 2024 and is expected to grow to $2.8 billion by 2031. North America holds a significant share, dominating the idiopathic hypersomnia treatment market with 50.5% in 2024.

• Sustained Market Penetration and Increased Patient Base for WAKIX in Narcolepsy: Harmony Biosciences continues to report strong demand and a growing patient base for its flagship product, WAKIX (pitolisant), for the treatment of narcolepsy. The company has consistently achieved record quarterly increases in the average number of patients on WAKIX, and management expects the drug to reach "blockbuster status," generating over $1 billion in annual revenue in narcolepsy alone.
• Launch of Next-Generation Pitolisant Formulations and Expansion into New Indications: Harmony Biosciences is advancing new formulations of pitolisant, including Pitolisant GR (gastro-resistant) and Pitolisant HD (high-dose/optimized pharmacokinetic profile). These next-generation formulations are designed to offer improved characteristics and extend the product's lifecycle, with patent protection for Pitolisant GR expected out to 2044. Additionally, the company is evaluating pitolisant for new indications, such as idiopathic hypersomnia, with Phase 3 trials for Pitolisant HD in this area expected to commence in Q4 2025.
• Advancement and Potential Commercialization of Novel Pipeline Assets: Harmony Biosciences is diversifying its pipeline beyond the current pitolisant franchise by developing new product candidates. A significant driver is BP1.15205, a highly potent and selective oral orexin-2 receptor agonist, which is an investigational compound for narcolepsy and other sleep/wake disorders. The first subject for BP1.15205 is expected to be dosed in Q4 2025. The company has also expanded its focus into rare epilepsies through strategic acquisitions, adding assets like EPX-100, which is in registrational Phase 3 trials. These new pipeline programs aim to address unmet medical needs in various neurological disorders and offer substantial future revenue potential.

Share Repurchases

• Harmony Biosciences' Board of Directors authorized a share repurchase program of up to $125 million on August 1, 2023.

Share Issuance

• Harmony Biosciences completed its initial public offering (IPO) on August 21, 2020, issuing 6,151,162 shares of common stock at $24.00 per share, resulting in gross proceeds of $147.6 million.
• Shares issued amounted to $2.1 million for the quarter ended June 2025.
• As of September 30, 2025, diluted shares outstanding were 58,717,910.

Capital Expenditures

• Capital expenditures were $0.30 million in 2021, $0.17 million in 2022, $37 million in 2023, and $34 million in 2024.