Q3 FY2026
Filed Nov 4, 2026WAKIX net revenue was $268.9 million in Q3 2026, up 12%, while Harmony reiterated full-year WAKIX net revenue guidance of $1.0 billion to $1.04 billion and reported preliminary BP-205 multiple-ascending dose data.
WAKIX demand remained strong, with $268.9 million of quarterly net revenue and 400 net patient adds, and the company reiterated its full-year revenue guidance. Profitability declined as royalty and milestone charges raised product costs and research and development expense.
Key metrics
shortened, hover for the filing’s print| Metric | Value | q/q | y/y |
|---|---|---|---|
| Q3 2026 net product revenueGAAP | $268.9M | – | 12% increase |
| Nine months ended September 30, 2026 net product revenueGAAP | $745.6M | – | – |
| Q3 2026 cost of product soldGAAP | $80.69M | – | 35% increase |
| Nine months ended September 30, 2026 cost of product soldGAAP | $188.4M | – | – |
| Q3 2026 cost of product sold as a percentage of WAKIX net revenueGAAP | 30% | – | – |
| Q3 2026 gross profitGAAP | $188.2M | – | – |
| Nine months ended September 30, 2026 gross profitGAAP | $557.2M | – | – |
| Q3 2026 research and development expensesGAAP | $71.66M | – | 30% increase |
| Nine months ended September 30, 2026 research and development expensesGAAP | $187.6M | – | – |
| Q3 2026 sales and marketing expensesGAAP | $34.72M | – | 18% increase |
| Nine months ended September 30, 2026 sales and marketing expensesGAAP | $100.5M | – | – |
| Q3 2026 general and administrative expensesGAAP | $27.65M | – | 7% decrease |
| Nine months ended September 30, 2026 general and administrative expensesGAAP | $88.21M | – | – |
| Q3 2026 total operating expensesGAAP | $134.0M | – | 17% increase |
| Nine months ended September 30, 2026 total operating expensesGAAP | $376.4M | – | – |
| Q3 2026 operating incomeGAAP | $54.20M | – | – |
| Nine months ended September 30, 2026 operating incomeGAAP | $180.8M | – | – |
| Q3 2026 other expense, netGAAP | −$316K | – | – |
| Nine months ended September 30, 2026 other expense, netGAAP | $(496) | – | – |
| Q3 2026 interest expenseGAAP | −$3.06M | – | – |
| Nine months ended September 30, 2026 interest expenseGAAP | −$9.36M | – | – |
| Q3 2026 interest incomeGAAP | $8.43M | – | – |
| Nine months ended September 30, 2026 interest incomeGAAP | $21.26M | – | – |
| Q3 2026 income before income taxesGAAP | $59.25M | – | – |
| Nine months ended September 30, 2026 income before income taxesGAAP | $192.2M | – | – |
| Q3 2026 income tax expenseGAAP | −$11.05M | – | – |
| Nine months ended September 30, 2026 income tax expenseGAAP | −$36.09M | – | – |
| Q3 2026 net incomeGAAP | $48.20M | – | – |
| Nine months ended September 30, 2026 net incomeGAAP | $156.1M | – | – |
| Q3 2026 comprehensive incomeGAAP | $46.98M | – | – |
| Nine months ended September 30, 2026 comprehensive incomeGAAP | $153.8M | – | – |
| Q3 2026 basic earnings per shareGAAP | $ 0.83 | – | – |
| Nine months ended September 30, 2026 basic earnings per shareGAAP | $ 2.68 | – | – |
| Q3 2026 diluted earnings per shareGAAP | $ 0.81 | – | – |
| Nine months ended September 30, 2026 diluted earnings per shareGAAP | $ 2.63 | – | – |
| Cash and cash equivalents as of September 30, 2026GAAP | $647.1M | – | – |
| Investments, short-term as of September 30, 2026GAAP | $124.0M | – | – |
| Investments, long-term as of September 30, 2026GAAP | $280.5M | – | – |
| Current portion of long-term debt as of September 30, 2026GAAP | $ 20,000 | – | – |
| Long-term debt, net as of September 30, 2026GAAP | $129.1M | – | – |
Segments
| Segment | Revenue | q/q | y/y |
|---|---|---|---|
| WAKIXStrong patient demand, disciplined commercial execution across the franchise and broad clinical utility; estimated average number of patients grew by 400 to 9,350 in Q3. | $268.9M | – | 12% increase |
Full year 2026 outlook
- Revenue$1.0 billion to $1.04 billion
- NotePhase 1b BP-205 data in sleep-deprived healthy volunteers expected in Q1 2027.
- NotePhase 2 studies evaluating multiple CNS indications expected to initiate by mid-2027.
- NotePitolisant GR PDUFA date: April 1, 2027.
- NotePitolisant HD topline data expected in 2027 and anticipated PDUFA date in 2028.
- NoteWAKIX TEMPO topline data expected in mid-2027 and anticipated PDUFA date in 2028.
- NoteEPX-100 topline data expected in mid-2027 and anticipated PDUFA date in 2028.
What drove it
- WAKIX net revenue was driven by strong patient demand, with estimated average patients increasing by 400 to 9,350 in Q3.
- All expanded field sales, remote sales, field reimbursement and patient outreach roles were hired, trained and fully deployed in Q2.
- Cost of product sold increased as a percentage of net product revenue primarily because of new royalties related to the Novitium license agreement.
- Research and development expense was primarily affected by a $25.0 million milestone charge for the MSN license agreement, partially offset by a $15.0 million clinical milestone charge for ZYN002 in the prior-year period.
- Sales and marketing expense increased primarily due to expansion of field-based teams.
- General and administrative expense declined primarily due to lower stock-based compensation expense.
Concerns
- Cost of product sold was 30% of WAKIX net revenue in Q3 2026, compared to 25% in the same quarter in 2025, due primarily to new Novitium license royalties.
- Net income declined to $48.2 million from $50.9 million, primarily due to higher milestone charges and new MSN royalty charges.
- Research and development expenses rose 30% to $71.7 million.
- The AET ANDA litigation ruling is expected around the time of the 30-month stay in February 2027; a preliminary injunction hearing is scheduled for January 26, 2027, with an expected decision by February 14, 2027.
- Jeffrey Dayno, MD, will retire on December 31, 2026, and Peter Anastasiou will become President and Chief Executive Officer effective January 1, 2027.
What to watch
- Whether WAKIX delivers full-year 2026 net revenue within the reiterated $1.0 billion to $1.04 billion guidance range.
- Phase 1b BP-205 data in sleep-deprived healthy volunteers expected in Q1 2027.
- Pitolisant GR FDA PDUFA date of April 1, 2027 and the planned 1H 2027 launch.
- Expected February 2027 developments in the AET ANDA litigation and preliminary injunction process.
- Topline data expected in 2027 for Pitolisant HD, and in mid-2027 for WAKIX TEMPO and EPX-100.
- The planned January 1, 2027 transition of the President and Chief Executive Officer role to Peter Anastasiou.
Balance sheet and cash flow
- Cash, cash equivalents and investments were $1,051.6 million as of September 30, 2026, compared to $882.5 million as of December 31, 2025.
- Cash and cash equivalents were $ 647,099 as of September 30, 2026, compared to $ 752,502 as of December 31, 2025.
- Total debt consisted of $ 20,000 of current portion of long-term debt and $ 129,104 of long-term debt, net, as of September 30, 2026.
- Operating cash flow and free cash flow were not reported.
Analysis
Harmony reported continued WAKIX demand momentum in Q3 2026. WAKIX net revenue was $268.9 million, compared with $239.5 million in the same quarter in 2025, representing a 12% increase. Estimated average patients increased by 400 to 9,350 in Q3, and management noted that five of the last six quarters achieved more than 400 patient additions. The company reiterated full-year 2026 WAKIX net revenue guidance of $1.0 billion to $1.04 billion.
The revenue increase did not translate into higher quarterly earnings. Cost of product sold was $80.7 million, or 30% of WAKIX net revenue, versus $59.7 million, or 25%, in the prior-year quarter. Management attributed the higher cost ratio primarily to new royalties associated with the Novitium license agreement. Total operating expenses increased 17% to $134.0 million, with research and development rising 30% to $71.7 million and sales and marketing rising 18% to $34.7 million. Operating income was $54.2 million, compared with $65.5 million, while net income was $48.2 million, compared with $50.9 million.
R&D spending reflects investment in the pipeline as well as milestone activity. The company cited a $25.0 million MSN license milestone charge in the quarter, partially offset by a $15.0 million ZYN002 clinical milestone charge in the prior-year period. BP-205 multiple-ascending dose data showed no liver or visual adverse events, no clinically significant cardiovascular events or EKG abnormalities, and no serious or severe adverse events. The company expects Phase 1b data in Q1 2027 and plans to initiate Phase 2 studies across multiple CNS indications by mid-2027.
The balance sheet supports the self-funded development and business-development strategy described in the release. Cash, cash equivalents and investments were $1,051.6 million as of September 30, 2026, compared with $882.5 million as of December 31, 2025. Key near-term franchise items include the April 1, 2027 PDUFA date for Pitolisant GR and the February 2027 timing around the AET ANDA litigation process. Management also reiterated confidence in WAKIX exclusivity to March 2030, inclusive of six months of pediatric exclusivity, while the planned CEO transition takes effect on January 1, 2027.
Management, verbatim
As I prepare to transition the President and CEO role to Peter on January 1, I believe Harmony is operating from a position of strength, with a durable and growing WAKIX franchise, the financial flexibility to invest in innovation, conviction to pursue strategic business development opportunities, and a pipeline led by BP-205 that has the potential to generate significant long-term value.
Jeffrey Dayno, MD, President and Chief Executive Officer of Harmony Biosciences
Not in the filing
stated, not guessed- Non-GAAP revenue, gross profit, operating income, net income, and EPS were not reported.
- Gross margin was not reported.
- Operating cash flow was not reported.
- Free cash flow was not reported.
- Share repurchases and dividends were not reported.
- Prior-quarter financial comparisons were not reported.
- Previous-release outlook was not provided; therefore, no comparison of actual results with prior guidance is included.
- No separately reported business segments were provided; WAKIX is presented as the product revenue line.
Written by an AI language model from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was checked against the filing text, and a metric whose value, prior period and change do not add up is dropped from the metrics. The model can still misread a table, in the metrics or in the text, so check a number in the filing before you rely on it. Consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.