Harmony Biosciences Holdings, Inc. Q1 FY2026 earnings call

• Four key pillars of value creation: protect the Pitocin franchise into 2030s, continued growth of Pitocin franchise, drive value from BP205 pipeline, renewed emphasis on business development. - For BP205, excitement around its orexin-2 agonist potential with novel chemical scaffold and high potency. - Ongoing development work including single ascending dose clinical PK data expected mid-year, multiple ascending dose study, food effect study, preclinical experiments for other CNS indications. - EPX100 clinical data showed median 50% reduction in seizures in Dravet Syndrome patients with favorable safety and tolerability. - Renewed emphasis on business development with organizational commitment to transact, strategic focus on revenue potential, core competencies, and broad CNS space.

Cost of goods or products sold was 20.7% of net sales in Q1 2026 compared to 17.3% one year ago, driven by new royalties from Novidium License Agreement. Total operating expenses for Q1 2026 were $133.6 million vs $96.5 million in Q1 2025. Net income for Q1 2026 was $32.5 million or $0.55 per share vs $45.6 million or $0.78 per share in Q1 2025. Ended Q1 2026 with $870.5 million in cash and cash equivalents and $160 million in debt.

• Ended Q1 2026 with $870.5 million in cash and cash equivalents. - Cash flow generation will reaccelerate in coming quarters and intent to deploy cash into business development for enhancing revenues in 2028 - 2032 timeframe. - Full-year guidance for WCAG is over a billion dollars, $1 billion to $1.04 billion.

• Seasonal market access headwinds for WCAG at start of year. - Litigation risks related to IP infringement with AET and Sandoz, including ongoing ANDA litigation and new suit over amorphous patent. - Competition in the orexin agonist space with multiple compounds in development potentially affecting BP205 launch.

Q: Give roadmap on BP205 data milestones, why not move to narcolepsy trials earlier, early stage work on other CNS indications.

A: On track for single ascending dose clinical PK data mid-year, do sleep-deprived healthy volunteer study to bracket dose range before clinical proof-of-concept, conducting preclinical experiments for other CNS indications.

Q: Talk about WCAG ramp, timing of second lawsuit on Novidium IP.

A: WCAG has strong demand, on track for full-year guidance, sued on Novidium IP after evidence of infringement in trial to assert full rights.