Harmony Biosciences Holdings, Inc.: Q2 FY2026 earnings call

What management said about Q2 FY2026, from the documents filed with the SEC on 4 August 2026: press release. Guidance figures: 8 new, 1 kept. The quarter’s numbers.

Read the filing

Key takeaways

• WAKIX net revenue rose 30%: Net product revenue was $261.3 million, compared with $200.5 million a year earlier, an increase of 30%. The company reported this as WAKIX revenue. Source
• Net income and diluted EPS rose: Net income was $75.4 million, or $1.28 per diluted share, compared with $39.8 million, or $0.68 per diluted share, in the second quarter of 2025. Source
• Average patients up 450: Estimated average patients for the quarter were approximately 8,950, an increase of 450. Management described this as the second-highest average patient growth ever. Source
• Cost of product sold rose on royalties: Cost of product sold was $63.2 million, or 24.2% of net product revenue, against 19.0% a year earlier. The company attributed the increase mainly to new royalties under the Novitium license. Source
• BP-205 Phase 1 PK profile: Phase 1 single ascending dose data showed a time to maximum concentration of 30 to 75 minutes and a mean half-life of about 25 hours, with dose-proportional exposure. Source
• WAKIX exclusivity runs to 2030: The pitolisant patent estate supports WAKIX exclusivity to March 2030, including six months of pediatric exclusivity. Other formulations may extend protection into the 2040s. Source
• Cash and investments reached $962.5 million: Cash, cash equivalents and investments were $962.5 million at June 30, 2026, compared with $882.5 million at December 31, 2025. Source

“Our record second-quarter revenue reflects sustained demand for WAKIX and keeps us firmly on track to deliver over $1 billion in revenue this year.”

Jeffrey M. Dayno, MD, President and Chief Executive Officer of Harmony Biosciences

Guidance

What changed from last quarter

• Guidance kept: The full-year 2026 WAKIX net revenue range of $1.0 billion to $1.04 billion was reiterated, unchanged from the July preannouncement. Source
• New guidance: A first-half 2027 launch timing for pitolisant GR was given; the July preannouncement did not include this timing. Source
• New: The FDA accepted the pitolisant GR NDA in July, after the prior quarter's report. Source
• New: Management is exploring an amorphous form of pitolisant to pursue broader CNS indications, based on an exclusive license. Source
• New: Stephen Mollichella, SVP and Controller, was appointed Interim Principal Financial Officer.
• Ended: Chief Financial Officer Glenn Reicin stepped down effective July 16, 2026.
• New: Single ascending dose data from the BP-205 Phase 1 study were shared for the first time in this release. Source

Results and growth drivers

• WAKIX net revenue rose 30%: Net product revenue was $261.3 million, compared with $200.5 million a year earlier, an increase of 30%. The company reported this as WAKIX revenue. Source
• Net income and diluted EPS rose: Net income was $75.4 million, or $1.28 per diluted share, compared with $39.8 million, or $0.68 per diluted share, in the second quarter of 2025. Source
• Sequential growth of 21%: The preannouncement stated second-quarter revenue grew 21% over the first quarter, in addition to 30% growth year over year.

Products and customers

• Average patients up 450: Estimated average patients for the quarter were approximately 8,950, an increase of 450. Management described this as the second-highest average patient growth ever. Source
• Field and reimbursement teams expanded: Field sales, remote sales, field reimbursement and patient outreach teams were expanded, with all roles hired, trained and deployed in the second quarter. Source
• Online portal to speed patient access: An online portal and changes to reimbursement support were launched so patients can secure WAKIX faster, with a higher success rate. Source
• Narcolepsy market size cited: Management described the narcolepsy market as about 80,000 diagnosed patients in the U.S., within which it reported continued demand for WAKIX. Source

“reinforce our conviction that BP-205 has the potential to be the best-in-class orexin-2 agonist with broad clinical utility across multiple CNS indications.”

Jeffrey M. Dayno, MD, President and Chief Executive Officer of Harmony Biosciences

Costs, margins and royalties

• Cost of product sold rose on royalties: Cost of product sold was $63.2 million, or 24.2% of net product revenue, against 19.0% a year earlier. The company attributed the increase mainly to new royalties under the Novitium license. Source
• R&D expense fell on prior up-front payment: R&D expense was $46.6 million, down 7%. The prior-year quarter included a $15.0 million up-front payment to CiRC that had no current-year equivalent. Source
• Sales and marketing up on field teams: Sales and marketing expense was $34.1 million, up 13%, primarily from the expansion of field-based teams. Source
• G&A fell on prior-year settlement charge: General and administrative expense was $28.1 million, down 17%, because the prior-year quarter included a charge related to an ANDA settlement. Source
• Total operating expenses declined: Total operating expenses were $108.8 million, down 5% from $114.2 million a year earlier. Source

Pipeline and development programs

• BP-205 Phase 1 PK profile: Phase 1 single ascending dose data showed a time to maximum concentration of 30 to 75 minutes and a mean half-life of about 25 hours, with dose-proportional exposure. Source
• BP-205 Phase 1 tolerability: Management said BP-205 was generally safe and well tolerated, with no serious or severe TEAEs. The most common adverse events were headache, fatigue and diarrhea. Source
• Pitolisant HD Phase 3 trials ongoing: Phase 3 trials ONSTRIDE 1 in narcolepsy and ONSTRIDE 2 in idiopathic hypersomnia are ongoing for an enhanced formulation with a higher dose and enteric coating. Source
• EPX-100 enrolling two epilepsy trials: Enrollment is active in two global Phase 3 registrational trials for rare epilepsies, the LIGHTHOUSE study in Lennox-Gastaut syndrome and the ARGUS study in Dravet syndrome. Source
• Pitolisant GR avoids titration: The enteric coating is meant to reduce GI side effects, which 80 to 90% of narcolepsy patients experience. It allows starting at a therapeutic dose without titration. Source

Patents, exclusivity and litigation

• WAKIX exclusivity runs to 2030: The pitolisant patent estate supports WAKIX exclusivity to March 2030, including six months of pediatric exclusivity. Other formulations may extend protection into the 2040s. Source
• Six of seven ANDA filers settled: The company has settled ANDA litigation with six of the seven filers. Litigation with the remaining filer, AET, is ongoing. Source
• Amorphous-form lawsuit filed in April: Harmony and Novitium filed a patent infringement lawsuit in April against AET Pharma US and its marketing partner Sandoz over an amorphous form of pitolisant hydrochloride. Source

Capital, cash and business development

• Cash and investments reached $962.5 million: Cash, cash equivalents and investments were $962.5 million at June 30, 2026, compared with $882.5 million at December 31, 2025. Source
• Business development focus areas: Business development targets sleep/wake, epilepsy, rare/orphan CNS and broader CNS areas, with a focus on assets in Phase 3, in registration or on the market. Source

Leadership transition

• Interim finance lead's background: Stephen Mollichella joined in 2021 and has led financial accounting, reporting, financial systems and controls, and supported business development.
• CFO departure not a disagreement: The company said the CFO's departure did not result from any disagreement on operations, policies or practices.
• No expected effect on performance: Management does not expect the CFO transition to affect the company's performance or momentum.

Coming up, as management said on 4 August 2026

• Closing arguments in AET case: The judge has scheduled closing arguments from both sides in the AET ANDA litigation, after the bench trial concluded and post-trial briefs became public. Source
• Permanent CFO search underway: The company is searching for a permanent CFO while Stephen Mollichella serves as interim principal financial officer.

Figures management reported

Risks management discussed

• Regulatory: Patent litigation is ongoing with AET, and a separate infringement lawsuit over an amorphous form is pending against AET and Sandoz. Source
• Financial: New royalties under the Novitium license raised cost of product sold as a share of net product revenue this quarter. Source
• Operational: The CFO stepped down in July, and the company has an interim principal financial officer while it searches for a permanent CFO.

Earlier plans management reported on

• On track: Completion of the TEMPO study is described as fulfilling the last FDA requirement for WAKIX pediatric exclusivity. Source
• On track: Management describes pitolisant HD as on track for Phase 3 topline data in 2027 and a target PDUFA date in 2028. Source
• Not stated: Management states a commitment to investing in a robust development program for BP-205, with Phase 2 studies in mid-2027. Source

Other quarters

• Q1 FY2026 earnings call
• Q4 FY2025 earnings call
• Q3 FY2025 results
• Q2 FY2025 results

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.