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Jun 30, 2023
Harmony Biosciences Q2 2023 Earnings Report
Reported financial results with WAKIX net revenue increasing by approximately 25% year-over-year.
Key Takeaways
Harmony Biosciences reported strong second-quarter results, driven by increased demand for WAKIX. Net product revenues reached $134.2 million, a 25% increase compared to the same period in 2022. The company is also making progress in its life cycle management programs, with several catalysts expected in the remainder of the year.
Net product revenues increased by approximately 25% year-over-year to $134.2 million.
The average number of patients on WAKIX increased by approximately 350 sequentially to approximately 5,450.
Completed enrollment in Phase 3 Idiopathic Hypersomnia (IH) INTUNE Study and on-track for topline data in the fourth quarter of 2023.
Board of Directors authorized a $125 million share repurchase program.
Revenue by Segment
Forward Guidance
Harmony Biosciences is focused on its life cycle management programs and expects a catalyst-rich remainder of the year.
Positive Outlook
- Completed enrollment of Phase 3 registrational trial (INTUNE Study) in adult patients with IH, nine months ahead of plan.
- On-track for topline data from the Myotonic Dystrophy (“DM1”) Phase 2 proof-of-concept signal detection trial in the fourth quarter of 2023.
- Working with Bioprojet on the submission to FDA of a supplemental new drug application (“sNDA”) for pediatric narcolepsy. Expect to submit the sNDA in the fourth quarter of 2023.
- Actively pursuing pediatric exclusivity for WAKIX and have made progress with FDA in aligning on the requirements.
- Entered into a new $185 million term loan facility, further strengthening the balance sheet and reducing annual interest expense by approximately $6 million.
Historical Earnings Impact
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Avg. Return Before/After Earnings
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