Q2 2026 Harmony Biosciences Holdings Inc Earnings Call Transcript
Key Points
- Record Q2 2026 net revenue of $261.3 million for WAKIX, up 30% year-over-year and 21% quarter-over-quarter, with full-year guidance reaffirmed at $1 billion to $1.04 billion.
- Encouraging Phase 1 SAD data for BP-205, a potential best-in-class Orexin-2 Receptor Agonist, showing rapid absorption (Tmax 30-75 min), a 25-hour half-life supporting once-daily dosing, and dose-proportional exposure.
- BP-205 demonstrated a favorable safety and tolerability profile in the SAD study, with no serious adverse events, cardiovascular, hepatic, or visual abnormalities, and only mild common AEs (headache, fatigue, diarrhea).
- Strong balance sheet with approximately $963 million in cash and investments, providing significant firepower for strategic business development and multiple potential transactions.
- Robust IP strategy with settlements with six of seven ANDA filers, supporting WAKIX exclusivity to March 2030, and potential to extend the Pitolisant franchise into the 2040s with next-generation formulations.
- Multiple upcoming data catalysts for BP-205, including MAD data in Q4 2026 and a Phase 1b sleep-deprived healthy volunteer study with top-line data expected in early 2027.
- WAKIX patient additions reached 8,950 average patients, up 450 from Q1, marking the highest Q2 increase in brand history and the second-highest all-time increase.
- Cost of products sold increased to 24.2% of net revenue in Q2 2026, up from 19% in the prior year, primarily due to new royalties from the Novitium license agreement.
- Phase 3 study in Prader-Willi syndrome (TEMPO) has been delayed to mid-2027 due to limited patient prevalence and enrollment challenges.
- BP-205 is behind competitors like Takeda in development timelines, and the company acknowledges it may not be first to market in narcolepsy or other hypersomnias.
- In the MAD study, BP-205 showed target engagement-related adverse events such as insomnia and polyuria, though transient and not serious, which could raise safety concerns.
- Ongoing litigation with AET and Novitium over patent infringement remains unresolved, with closing arguments scheduled for October 2026, creating uncertainty around IP protection.
- The company faces potential competitive pressure in the Orexin-2 agonist space, with other players advancing similar programs, and the need to differentiate BP-205 in broader CNS indications.
Good morning, everyone. My name is Bo, and I will be your conference operator today. At this time, I would like to welcome everyone to the Harmony Biosciences second-quarter financial results conference call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions) I would now like to turn the call over to Mr. Brandon Doyle, Head of Investor Relations. Please go ahead, sir.
Good morning, everyone, and thank you for joining us today as we review Harmony Bioscience's second-quarter 2026 financial results and provide a business update. Before we start, I encourage everyone to go to the investor section of our website to find the materials that accompany today's discussion, including a reconciliation of our GAAP to non-GAAP financial measures. At this stage of our life cycle, we believe non-GAAP financial results better represent the underlying business performance.
Our speakers on today's call are Dr. Jeffrey Dano, President and
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