• Net Product Revenue (2024): $714.7 million, representing 23% growth year over year.
• Q4 2024 Net Revenue: $201.3 million.
• Cash and Cash Equivalents: Approximately $576 million.
• Non-GAAP Adjusted Net Income (Q4 2024): $63 million or $1.08 per diluted share.
• Operating Expenses (Q4 2024): $91.1 million, a 7% increase from the previous year.
• 2025 Revenue Guidance: $820 million to $860 million.
• Cash Generation from Operations (2024): Approximately $219.8 million.
• Average Patients on WAKIX (Q4 2024): Approximately 7,100.

• Warning! GuruFocus has detected 10 Warning Signs with GFL.

Release Date: February 25, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Harmony Biosciences Holdings Inc (NASDAQ:HRMY) reported a 23% year-over-year growth in net product revenues, reaching $714.7 million in 2024.
• The company achieved strong commercial performance with WAKIX, generating $201.3 million in net revenue in Q4 2024 alone.
• Harmony Biosciences Holdings Inc (NASDAQ:HRMY) has a robust late-stage CNS pipeline, with potential peak sales opportunities of $1 billion to $2 billion each for its three orphan rare neurology franchises.
• The company announced a generic settlement agreement with Novogen Pharma, reinforcing the strength of its intellectual property portfolio.
• Harmony Biosciences Holdings Inc (NASDAQ:HRMY) maintains a strong financial position with $576 million in cash and cash equivalents, allowing it to self-fund its pipeline growth and strategic acquisitions.

Negative Points

• The supplemental new drug application for pitolisant in idiopathic hypersomnia faced challenges as the Phase 3 INTUNE study did not meet its primary endpoint.
• The company received a Refusal to File (RTF) letter from the FDA for the pitolisant sNDA in idiopathic hypersomnia, indicating regulatory hurdles.
• There is competition for patient enrollment in clinical trials, particularly for pitolisant HD trials, which may impact timelines.
• The company faces ongoing patent litigation with multiple ANDA filers, although it has reached a settlement with one.
• Harmony Biosciences Holdings Inc (NASDAQ:HRMY) anticipates increased R&D expenses in 2025, which may impact short-term profitability.

Q & A Highlights

Q: Can you provide more details on the ZYN002 Phase 3 study, particularly regarding patient enrollment and the open-label extension? A: (Kumar Budur, EVP and Chief Medical & Scientific Officer) We are on track for topline data in the third quarter of this year. The primary endpoint is in patients with complete methylation, but we are also enrolling a nominal number of patients with partial methylation. We are enrolling patients aged 3 to 30 years, and the weight varies. A good proportion of patients are rolling over into the long-term extension study, with some exposed to ZYN002 for over eight years, indicating durable efficacy.

Q: Why should we feel comfortable that pitolisant HD has a higher likelihood of success in IH patients? A: (Kumar Budur, EVP and Chief Medical & Scientific Officer) The INTUNE study showed significant efficacy in the open-label part. Pitolisant HD is an optimized formulation with a higher dose, showing a clear dose-response relationship. We are confident it will be efficacious in IH, impacting symptoms like sleep inertia, which has no approved treatments. The upcoming study will be a double-blind, placebo-controlled, randomized parallel study.

Q: How confident are you in the 2028 PDUFA assumptions for pitolisant HD, given competition for patients? A: (Kumar Budur, EVP and Chief Medical & Scientific Officer) There are fewer trials in idiopathic hypersomnia compared to narcolepsy, and our robust signal from the INTUNE study will aid recruitment. This is a global trial, and we have established relationships with sites. We are confident in our timeline for both IH and narcolepsy trials.

Q: Can you comment on the status of remaining patent challenges and upcoming litigation timelines? A: (Jeffrey Dayno, President, CEO, Director) We announced a settlement with Novugen Pharma, one of seven ANDA filers. The Markman Hearing is scheduled for March, setting up claims construction, followed by a trial in 2026. We are actively engaged with other ANDA filers and will provide updates as appropriate. The Novugen settlement reinforces the strength of our intellectual property.

Q: What would be considered a successful outcome for the ZYN002 trial, and will the FDA accept the CONNECT study data? A: (Kumar Budur, EVP and Chief Medical & Scientific Officer) Success will be defined by a statistically significant and clinically meaningful outcome on the primary endpoint, the social avoidance subscale in patients with complete methylation. The FDA will accept the CONNECT study data as supporting evidence in our NDA package if the study is positive.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.