On August 6, 2024, Harmony Biosciences Holdings Inc (HRMY, Financial) released its 8-K filing detailing the financial results for the second quarter of 2024. Harmony Biosciences Holdings Inc is a commercial-stage pharmaceutical company focused on developing and commercializing therapies for patients living with rare neurological diseases who have unmet medical needs. The company's product WAKIX (pitolisant) is designed to increase histamine signaling in the brain by binding to H3 receptors and is used for the treatment of cataplexy in adult patients with narcolepsy.
Financial Performance Overview
Harmony Biosciences reported net product revenues of $172.8 million for the quarter ended June 30, 2024, representing a 29% increase compared to $134.2 million for the same period in 2023. This growth was primarily driven by strong commercial sales of WAKIX, tapping into a large market opportunity with approximately 80,000 patients diagnosed with narcolepsy in the US.
Income and Earnings
GAAP net income for the quarter was $11.6 million, or $0.20 earnings per diluted share, compared to $34.3 million, or $0.56 earnings per diluted share, for the same period in 2023. The decrease in GAAP net income was primarily driven by a $25.5 million upfront licensing fee paid as part of the 2024 Bioprojet Sublicensing Agreement for TPM-1116 and a $17.1 million IPR&D charge related to the acquisition of Epygenix. Non-GAAP adjusted net income was $60.6 million, or $1.05 earnings per diluted share, compared to $45.9 million, or $0.76 per diluted share, for the same period in 2023.
Balance Sheet and Cash Flow
As of June 30, 2024, Harmony Biosciences had cash, cash equivalents, and investments totaling $434.1 million, compared to $425.6 million as of December 31, 2023. The company reiterated its 2024 net product revenue guidance of $700 million to $720 million.
Strategic Developments
Harmony Biosciences continues to advance its pitolisant high-dose (HD) development program, targeting a PDUFA date in 2028, which could extend the pitolisant franchise beyond 2040. The company also received FDA approval and launched WAKIX for the treatment of excessive daytime sleepiness (EDS) in pediatric patients with narcolepsy, providing the first and only non-scheduled treatment option.
“We made substantial progress and continue to advance our pitolisant high-dose development program, targeting a PDUFA date in 2028, giving us the opportunity to extend the pitolisant franchise beyond 2040,” said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony.
Key Metrics and Analysis
The average number of patients on WAKIX increased by approximately 250 sequentially to approximately 6,550 for the quarter ended June 30, 2024. This growth underscores the broad clinical utility of WAKIX across the approximately 9,000 healthcare providers that Harmony Biosciences calls on, about 5,000 of whom do not participate in an oxybate REMS program.
| Metric | Q2 2024 | Q2 2023 |
|---|---|---|
| Net Product Revenues | $172.8 million | $134.2 million |
| GAAP Net Income | $11.6 million | $34.3 million |
| Non-GAAP Adjusted Net Income | $60.6 million | $45.9 million |
| Cash, Cash Equivalents, and Investments | $434.1 million | $425.6 million |
Conclusion
Harmony Biosciences Holdings Inc (HRMY, Financial) demonstrated robust revenue growth in the second quarter of 2024, driven by the strong performance of WAKIX. Despite a decrease in GAAP net income due to significant upfront licensing fees and acquisition charges, the company's strategic advancements and continued focus on addressing unmet medical needs in the narcolepsy market position it well for future growth. Investors and stakeholders will be keenly watching the progress of the pitolisant high-dose development program and other pipeline initiatives.
Explore the complete 8-K earnings release (here) from Harmony Biosciences Holdings Inc for further details.
