Harmony Biosciences — Q3 2026 Earnings Summary

Financial Performance:

• WAKIX net revenue for Q3 2026 was $268.9 million, a 12% increase compared to $239.5 million in Q3 2025.
• Total net product revenue for the nine months ended September 30, 2026, was $745.6 million, compared to $624.7 million in the same period of 2025.
• Cost of product sold was $80.7 million (30% of WAKIX net revenue) in Q3 2026, up from $59.7 million (25%) in Q3 2025, driven by new royalties related to the Novitium license agreement.
• Net income for Q3 2026 was $48.2 million ($0.81 per diluted share), compared to $50.9 million ($0.87 per diluted share) in Q3 2025; the decline was attributed to increased milestone charges and new MSN royalty charges.
• Research and development expenses were $71.7 million in Q3 2026, a 30% increase from $55.0 million in Q3 2025, primarily driven by a $25.0 million milestone charge for the MSN license agreement.
• Sales and marketing expenses were $34.7 million in Q3 2026, an 18% increase from $29.5 million in Q3 2025, driven by field team expansion.
• General and administrative expenses were $27.7 million in Q3 2026, a 7% decrease from $29.8 million in Q3 2025, primarily due to lower stock-based compensation.
• Total operating expenses were $134.0 million in Q3 2026, up 17% from $114.3 million in Q3 2025.
• Cash, cash equivalents, and investments totaled $1,051.6 million as of September 30, 2026, compared to $882.5 million as of December 31, 2025.
• Current assets increased to $934.8 million from $907.0 million, while total assets rose to $1,478.2 million from $1,271.6 million.
• Total liabilities increased to $406.0 million from $401.4 million; long-term debt, net, decreased to $129.1 million from $143.7 million.
• Retained earnings increased to $317.0 million from $160.9 million.

Guidance and Future Outlook:

• Reiterated full-year 2026 WAKIX net revenue guidance of $1.0 billion to $1.04 billion.
• BP-205 Phase 1b data in sleep-deprived healthy volunteers expected in Q1 2027, with Phase 2 studies in multiple CNS indications expected to initiate by mid-2027.
• Pitolisant GR NDA under FDA review with a PDUFA date of April 1, 2027.
• Pitolisant HD Phase 3 topline data expected in 2027, with a target PDUFA date in 2028.
• WAKIX Phase 3 trial in Prader-Willi syndrome (TEMPO) topline data expected in mid-2027, with an anticipated PDUFA date in 2028.
• EPX-100 Phase 3 topline data in rare epilepsies expected in mid-2027, with an anticipated PDUFA date in 2028.
• Management expects to achieve WAKIX exclusivity through March 2030, inclusive of six months of pediatric exclusivity.

Business Segments and Product Lines:

• WAKIX net patient count grew by 400 to 9,350 in Q3 2026, with 5 of the last 6 quarters achieving more than 400 patient additions.
• WAKIX is the only non-scheduled treatment option for excessive daytime sleepiness and cataplexy in adult and pediatric patients with narcolepsy type 1 and 2.
• BP-205 (investigational orexin-2 receptor agonist) demonstrated favorable safety, tolerability, and pharmacokinetic profiles in a 14-day multiple-ascending dose study involving 94 healthy volunteers; no liver, visual, or clinically significant cardiovascular events were reported.
• BP-205 is being developed in partnership with Bioprojet and discovered by Teijin Pharma.
• Pitolisant GR (gastro-resistant) tablets are designed to enable treatment initiation at a therapeutic dose without titration.
• Pitolisant HD (high dose) is being evaluated for differentiated labeling targeting fatigue in narcolepsy and sleep inertia in idiopathic hypersomnia.
• EPX-100 (clemizole hydrochloride) is actively enrolling in Phase 3 trials for Lennox-Gastaut syndrome (LIGHTHOUSE Study) and Dravet syndrome (ARGUS Study).
• Harmony holds an exclusive license to Novitium's amorphous pitolisant patent with protection until 2042.
• Harmony obtained exclusive rights to a patent covering methods of making amorphous pitolisant hydrochloride from MSN Labs in Q1 2026.

Market and Competitive Landscape:

• Approximately 170,000 people in the U.S. are living with narcolepsy, with fewer than 50% diagnosed and brand penetration at approximately 20%.
• WAKIX has coverage for more than 80% of covered lives.
• Harmony is pursuing business development opportunities in Sleep Disorders, Epilepsy, Rare/Orphan CNS, and broader CNS indications.
• A poster presented at SLEEP EU 2026 suggested a potential synergistic therapeutic approach using concomitant use of an orexin-2 agonist and pitolisant.

Risks and Challenges:

• Ongoing legal proceedings regarding pitolisant intellectual property, including the AET ANDA litigation and infringement lawsuits against AET Pharma US and Sandoz.
• The timing of regulatory approvals for pitolisant in additional indications and other product candidates.
• Dependence on the commercial success of WAKIX and the potential profile of product candidates like BP-205 and EPX-100.
• Risks associated with market acceptance, reimbursement, and competition in the industry.
• Potential volatility in the price of common stock and macroeconomic effects.

Management Commentary and Tone:

• Jeffrey Dayno, MD, President and CEO, stated the company is operating from a position of strength with a durable WAKIX franchise and financial flexibility to invest in innovation.
• Peter Anastasiou, Senior Executive Vice President and Chief Operating Officer, will succeed Jeffrey Dayno as President and CEO effective January 1, 2027.
• Management emphasized confidence in the pipeline led by BP-205 and the ability to pursue strategic business development opportunities.
• The leadership transition is not expected to change strategic priorities or the timing of key commercial and pipeline milestones.

Other Key Points:

• Harmony is asserting a multi-layered IP strategy across active legal proceedings to reinforce WAKIX exclusivity.
• A preliminary injunction hearing for the amorphous form patent ('920) is scheduled for January 26, 2027, with an expected decision by February 14, 2027.
• Harmony has settled with 6 of the 7 ANDA filers.
• Capital allocation priorities include investing in the R&D pipeline (especially BP-205), success-based R&D milestone payments, and strategic business development.
• The company is exploring the amorphous form of pitolisant to pursue broader CNS indications.
• Updated 18-month data from the ARGUS study will be presented at the American Epilepsy Society Annual Meeting in December 2026.