Harmony Biosciences Holdings, Inc. Q1 FY2025 earnings call

Key Points:

• Introduced new Chief Commercial Officer Adam Zaeske, who has made an impact in a short time.
• Q1 2025 was a strong quarter with WAKIX net product revenue growing 20% year-over-year.
• Pipeline highlights: ZYN002 Phase 3 RECONNECT study on track for top-line data in Q3 2025; pitolisant HD set to initiate Phase 3 trials in Q4 2025; pitolisant GR pivotal B study started in Q1 2025 with top-line data expected in Q3 2025; orexin receptor agonist BP1.15205 in preclinical development.
• Business development: Over $600 million in cash, actively seeking to strengthen pipeline.
• Supply chain: Progress on secondary manufacturing site for WAKIX in the US.

In Q1 2025, Harmony Biosciences' core commercial business showed strong performance. The net product revenue for WAKIX in narcolepsy was $184.7 million, representing a 20% year-over-year increase. WAKIX, as the first and only FDA-approved nonscheduled treatment for narcolepsy, continues to drive growth. This revenue contributes significantly to the overall financial performance of the company.

Guidance:

• Net revenue guidance for 2025 remains in the range of $820 million to $860 million.
• Confident in WAKIX reaching $1 billion plus opportunity in narcolepsy alone.
• Anticipate increased R&D investments as they advance multiple Phase 3 registrational trials in the pipeline.

Risks:

• Geopolitical risks such as potential new tariffs.
• Supply chain risks related to manufacturing sites for WAKIX.

Q: On ZYN002, what are the powering assumptions and risk mitigation strategies for the study?

A: Kumar Budur stated the study is powered over 90% for the primary endpoint (change in social avoidance severity) and emphasized checks and balances in the trial, including rigorous patient criteria and caregiver training.

Q: Adam, could you share your thoughts on the commercial team and strategies supporting WAKIX?

A: Adam Zaeske highlighted strong fundamentals, patient-centric approach, and confidence in continued growth of WAKIX, reaffirming the net revenue guidance range.

Q: Discuss orexin agonists and the payer landscape for WAKIX?

A: Kumar Budur discussed orexin agonists' potential and Adam Zaeske noted stable payer coverage for WAKIX despite generic oxybate competition.

Q: Thoughts on market dynamics for orexins and EPX-100's potential in broader DEE indications?

A: Kumar Budur talked about orexin market dynamics and potential broader use of EPX-100, while Adam Zaeske emphasized WAKIX's strong fundamentals.

Q: What are the drivers of revenue guidance and details on pitolisant HD Phase 3 design?

A: Adam Zaeske and Sandip Kapadia discussed revenue drivers, and Kumar Budur detailed pitolisant HD trial design, including study timelines and endpoints.

Q: Timeline for ZYN002 NDA submission and market opportunity?

A: Kumar Budur and Jeffrey Dayno mentioned swift NDA submission upon positive data and significant market opportunity in Fragile X and 22q syndromes.

Q: Thoughts on competitor Shionogi's program and WAKIX patient split?

A: Kumar Budur noted differences in Shionogi's program and Adam Zaeske discussed WAKIX patient split between oxybate experienced and naïve patients.

Q: Orexin data at upcoming sleep meeting and payer coverage for WAKIX?

A: Kumar Budur discussed upcoming orexin data and Jeffrey Dayno addressed stable payer coverage for WAKIX.

Q: Trends for WAKIX and timeline for pitolisant HD Phase 3 start?

A: Adam Zaeske talked about WAKIX trends and Kumar Budur provided timeline details for pitolisant HD Phase 3 initiation.