PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) reported a 29% increase in net revenue for the quarter ended June 30, 2024. The company highlighted progress in its pitolisant-HD development program, targeting a PDUFA date in 2028.
“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. “In addition, we are executing on our late-stage pipeline across three orphan/rare CNS franchises, which we expect to deliver at least one new product or indication launch every year over the next five years, with multi-billion-dollar revenue potential extending beyond 2040.”
Key Franchise Highlights
- WAKIX net revenue for the quarter was $172.8 million, up 29% from the previous year.
- The average number of patients on WAKIX increased by 250 to 6,550.
- The USPTO upheld the WAKIX patent, denying a reexamination petition.
- The FDA approved WAKIX for treating pediatric narcolepsy in June 2024, with a commercial launch in July 2024.
- Harmony plans to submit a supplemental new drug application for pitolisant in IH in Q4 2024.
- Pitolisant Gastro-Resistant: Dosing Optimization study starts in Q4 2024, with a PDUFA date expected in 2026.
- Pitolisant HD: Pilot PK data showed a 20% increase in bioavailability, with a PDUFA date expected in 2028.
- Ongoing Phase 3 TEMPO study for Prader-Willi syndrome.
- TPM-1116, an orexin-2 receptor agonist, is expected to enter first-in-human studies in the second half of 2025.
- Pre-clinical POC study for HBS-102 in PWS showed encouraging results.
Second Quarter 2024 Financial Results
Net product revenues rose to $172.8 million, up from $134.2 million in 2023. GAAP net income was $11.6 million, or $0.20 per diluted share, down from $34.3 million, or $0.56 per diluted share, the previous year. Non-GAAP adjusted net income was $60.6 million, or $1.05 per diluted share, up from $45.9 million, or $0.76 per diluted share.
Operating Expenses
- Research and Development expenses were $63.6 million, driven by a $25.5 million licensing fee and a $17.1 million IPR&D charge.
- Sales and Marketing expenses were $28.5 million, up 16%.
- General and Administrative expenses were $27.2 million, up 19%.
- Total Operating Expenses were $119.3 million, compared to $62.3 million in 2023.
Financial Position
As of June 30, 2024, Harmony had $434.1 million in cash, cash equivalents, and investments.
2024 Guidance and Share Repurchase
Harmony expects full-year 2024 net product revenue between $700 million and $720 million. The company has $150 million authorized for share repurchases.
Investor Day
Harmony will host an investor day in New York City on October 1st, 2024.
A Promising Hold with Growth Potential
Given the company’s strong revenue growth and pipeline expansion, Harmony Biosciences is a Hold. The firm’s strategic initiatives and financial health support long-term growth, but investors should watch for progress on key development milestones.
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