Harmony Biosciences Holdings, Inc. Q4 FY2025 earnings call

• CEO Jeffrey Dayno recognized the team's outstanding quarter and year, noting WAKIX's strong performance with 400-plus average patient adds for three consecutive quarters and guidance to $1 billion to $1.04 billion in 2026 net revenue. • Chief Commercial Officer Adam Zaeske discussed WAKIX's sustained momentum, unique position as the only non-scheduled treatment, expansion of field-based teams, new online portal launch, and excitement over FDA approval for pediatric cataplexy. • Chief Medical and Scientific Officer Kumar Budur provided updates on clinical development, including WAKIX's new pediatric cataplexy approval, progress of pitolisant GR and HD programs, ongoing Phase III trials for various CNS indications, and new opportunity to explore broader CNS indications with a new pitolisant formulation. • CFO Sandip Kapadia highlighted strong financial performance in 2025, with net revenues above guidance, profitable cash-generating company status, and $882.5 million in cash, cash equivalents, and investments at quarter end.

In Q4 2025, WAKIX generated $243.8 million in net product revenue, up from $201.3 million in the same period last year. For full year 2025, WAKIX generated $868.5 million in net product revenue. WAKIX' net revenue is guided to $1 billion to $1.04 billion for 2026. The next generation pitolisant franchise is being advanced with pitolisant GR on track for NDA submission in Q2 2026 and pitolisant HD in Phase III trials.

• Reiterated WAKIX net revenue guidance for 2026 of $1 billion to $1.04 billion. • Anticipated typical seasonal dynamics in Q1 2026 with higher gross to net deductions and potential trade inventory drawdown. • Expected significant increases in R&D investments with 5 ongoing registrational Phase III programs and plan for a sixth Phase III study later in 2026. • Business development as a high priority to deploy capital for expanding pipeline and commercial portfolio.

• Uncertainty regarding the outcome of the ongoing legal trial related to IP for WAKIX, which could impact generic entry timelines. • Potential earlier-than-expected loss of exclusivity if not successful in the legal process, which could affect cash conservation and bridging to other development stage assets and commercialization.

Q: Pete Stavropoulos with Cantor Fitzgerald asked about EPX-100 for Dravet, including baseline seizure rates, antiseizure med use, comparison to real-world patients and other trials, and emerging benefit risk profile.

A: Kumar Budur responded discussing treatment-resistant seizures, baseline seizures comparable to other studies, about 50% median reduction in seizures, and good safety and tolerability profile.

Q: David Amsellem with Piper Sandler asked about orexin-2 agonist's PK/PD data in second half, target indications beyond narcolepsy and IH, and cash conservation if patent case not prevailed.

A: Kumar Budur and Sandip Kapadia responded on PK/PD data, target indications beyond primary disorders, and strong cash position.

Q: Jay Olson with Oppenheimer asked about gating factors to pitolisant GR NDA filing and enrollment pace for pitolisant HD studies.

A: Kumar Budur and Adam Zaeske responded on no gating factors for pitolisant GR NDA filing and confidence in enrollment pace for pitolisant HD studies.

Q: Ryan Ries on for Greg with Mizuho asked about increase in SG&A in Q4 and updates on EPX-200.

A: Sandip Kapadia and Kumar Budur responded on SG&A drivers and pre-IND work on EPX-200.

Q: Alex Nackenoff on for Danielle with Truist Securities asked about enrollment in ONSTRIDE 1 and 2 studies and nature of OpEx expenditure from settlements.

A: Kumar Budur and Sandip Kapadia responded on enrollment status and OpEx nature.

Q: Corinne Jenkins with Goldman Sachs asked about litigation timeline, regulatory exclusivity, and impact of settlements on acceleration clauses.

A: Jeffrey Dayno responded on ongoing legal process, stay in place, and progress on settlements.

Q: Patrick Trucchio with H.C. Wainright asked about WAKIX 2026 guidance patient growth and incremental contribution from pediatric cataplexy indication, and pitolisant's efficacy in MS fatigue and Phase I PK study timeline.

A: Adam Zaeske and Kumar Budur responded on patient growth and pediatric cataplexy contribution, and pitolisant's efficacy data and Phase I PK study progress.

Q: Pavan Patel on for Jason Gerberry with Bank of America asked about investment in field sales and reimbursement teams for core market vs new launches, and BD as capital allocation priority.

A: Adam Zaeske and Jeffrey Dayno and Sandip Kapadia responded on investment focus and BD priorities.

Q: So Youn Shim with UBS asked about settlement impact on generic entry timeline without pediatric exclusivity and PWS indication for WAKIX.

A: Jeffrey Dayno and Kumar Budur responded on generic entry timeline and PWS indication opportunity.

Q: David Hoang with Deutsche Bank asked about new pitolisant formulation characteristics and IP estate for pitolisant products.

A: Kumar Budur and Jeffrey Dayno responded on formulation characteristics and IP details.

Q: Poorna Kannan on for Ami with Needham & Company asked about enrollment updates for ARGUS and LIGHTHOUSE studies and impact of sales force expansion.

A: Kumar Budur and Adam Zaeske responded on enrollment progress and sales force expansion impact timeline.