olivLaw · US equity research
Harmony Biosciences Holdings, Inc. HRMY
Pharmaceutical Preparations · SIC 2834 · Vertical: Pharmaceutical Preparations (SIC 2834)
Harmony Biosciences is a neuroscience company focused on rare neurological diseases, with its main product WAKIX (pitolisant) for narcolepsy generating net product revenue of 868.5 million USD in fiscal 2025. In the second quarter of 2026 revenue rose 30% year over year, and the company reiterated its 2026 WAKIX guidance of 1.0 to 1.04 billion USD, so dependence on a single product and its trajectory remain central to the analysis.
The AI analysis may be outdated: new filings came after its sources (see the «AI analysis» section).
At the close of 04 Nov 2026, Harmony Biosciences Holdings, Inc. (HRMY) stock was 34.42 USD (−7.04% on the day), with market capitalisation 2.0 bn USD, P/E 11.4 on diluted EPS of 3.03 USD over the last 12 months, beta 0.60, 52-week range 26.54–42.86 USD. Latest reported quarter (Q3 2026): revenue of 268.9 m USD (+12.3% YoY), net income of 48.2 m USD (−5.2% YoY), diluted EPS 0.81 USD.
Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.
Price history
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Technical reading
- RSI (14)
- 32.1
- weak (30–45)
- Bollinger (20, 2)
- 35.22 – 40.33
- below the lower band · %B -0.16 · band width 13.5%
- SMA 50 / 200
- 39.64 / 34.69
- mixed trend
- MACD (12, 26, 9)
- -0.74 / -0.61
- MACD below signal
Indicators describe past prices; on their own they do not predict direction. On our history the RSI ≤ 40 filter added no return (see the signals methodology).
Performance
| Company | S&P 500 | vs S&P 500 | Vertical median | |
|---|---|---|---|---|
| 1 month | −13.8% | −1.1% | −12.7 pp | — |
| 3 months | −10.0% | −0.5% | −9.6 pp | — |
| 6 months | +5.0% | +4.4% | +0.6 pp | — |
| Year to date | −8.0% | +12.3% | −20.3 pp | — |
| 1 year | +12.0% | +13.5% | −1.5 pp | −9.2% |
| 3 years | +32.8% | +76.4% | −43.6 pp | +50.7% |
| 5 years | −18.0% | +63.7% | −81.7 pp | — |
Price returns, dividends excluded.
Quarterly results
Latest quarter: Q3 2026 · 30 Sept 2026
Quarterly margins
Quarterly statements · USD
| Fiscal year | Q4 '24 | Q1 '25 | Q2 '25 | Q3 '25 | Q4 '25 | Q1 '26 | Q2 '26 | Q3 '26 |
|---|---|---|---|---|---|---|---|---|
| Revenue | 201.3 m | 184.7 m | 200.5 m | 239.5 m | 243.8 m | 215.4 m | 261.3 m | 268.9 m |
| Cost of revenue | 54.4 m | 32.0 m | 38.2 m | 59.7 m | 68.5 m | 44.5 m | 63.2 m | 80.7 m |
| Gross profit | 146.9 m | 152.7 m | 162.3 m | 179.8 m | 175.2 m | 170.9 m | 198.1 m | 188.2 m |
| Research & development | 34.7 m | 34.5 m | 50.2 m | 55.0 m | 49.9 m | 69.4 m | 46.6 m | 71.7 m |
| Operating income | 55.7 m | 56.2 m | 48.2 m | 65.5 m | 38.6 m | 37.3 m | 89.3 m | 54.2 m |
| Interest expense | 4.2 m | 3.8 m | 3.6 m | 3.6 m | 3.5 m | 3.2 m | 3.1 m | 3.1 m |
| Pre-tax income | 56.2 m | 57.2 m | 49.6 m | 67.5 m | 40.8 m | 39.7 m | 93.3 m | 59.2 m |
| Income tax | 6.7 m | 11.6 m | 9.9 m | 16.6 m | 18.3 m | 7.2 m | 17.8 m | 11.1 m |
| Net income | 49.5 m | 45.6 m | 39.8 m | 50.9 m | 22.5 m | 32.5 m | 75.4 m | 48.2 m |
| Diluted EPS | 0.85 ≈ | 0.78 | 0.68 | 0.87 | 0.39 ≈ | 0.55 | 1.28 | 0.81 |
| Operating cash flow | 75.6 m | 34.0 m | 79.3 m ≈ | 108.7 m ≈ | 126.2 m | 27.8 m | 92.4 m ≈ | 76.7 m ≈ |
| Capex | 513.0 k | 128.0 k | 4.0 k ≈ | 71.0 k ≈ | 107.0 k | — | — | — |
≈ derived quarter (cumulative difference / share-days average)
E/P over time
E/P = trailing-12-month diluted EPS / price at quarter end. E/P is the inverse of P/E and stays defined when earnings are negative.
Today's P/E sits at the 23 percentile of its own 22-quarter history (min 8.7, median 14.1, max 195.2; quarters with earnings only).
Fiscal years
| Fiscal year | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|
| Revenue | 6.0 m | 159.7 m | 305.4 m | 437.9 m | 582.0 m | 714.7 m | 868.5 m |
| Revenue YoY | unavailable | +2,564.6% | +91.2% | +43.4% | +32.9% | +22.8% | +21.5% |
| Net income | -152.0 m | -36.9 m | 34.6 m | 181.5 m | 128.9 m | 145.5 m | 158.7 m |
| Net income YoY | unavailable | unavailable | unavailable | +424.5% | −29.0% | +12.9% | +9.1% |
| Diluted EPS | -24.07 | -2.48 | 0.58 | 2.97 | 2.13 | 2.51 | 2.71 |
| Diluted EPS YoY | unavailable | unavailable | unavailable | +412.1% | −28.3% | +17.8% | +8.0% |
| net % | -2,535.1% | -23.1% | 11.3% | 41.4% | 22.1% | 20.4% | 18.3% |
| Free cash flow | -75.6 m | -3.0 m | 98.3 m | 144.3 m | 219.1 m | 218.7 m | 347.9 m |
Reported results vs expectations
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Balance sheet & financial health
Fiscal year 2025 · 31 Dec 2025
- Cash
- 752.5 m USD
- Financial debt
- 163.7 m USD
- Net debt
- -588.8 m USD
- Equity
- 870.2 m USD
- Total assets
- 1.3 bn USD
- Debt / equity
- 0.19x
- Current ratio
- 3.60x
- ROE
- 20.8%
- ROA
- 14.0%
- FCF margin
- 40.1%
Financial statements (source on every figure)
Revenue and net income (USD)
Margins
Income statement · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Revenue | 159.7 m | 305.4 m | 437.9 m | 582.0 m | 714.7 m | 868.5 m | SEC (XBRL)· 24 Feb 2026verified |
| Cost of revenue | 27.7 m | 55.5 m | 83.5 m | 121.2 m | 156.8 m | 198.3 m | SEC (XBRL)· 24 Feb 2026verified |
| Gross profit | 132.0 m | 249.9 m | 354.4 m | 460.8 m | 557.9 m | 670.1 m | SEC (XBRL)· 24 Feb 2026verified |
| Research & development | 19.4 m | 30.4 m | 70.9 m | 76.1 m | 145.8 m | 189.6 m | SEC (XBRL)· 24 Feb 2026verified |
| Operating income | 17.0 m | 87.5 m | 120.2 m | 192.0 m | 190.8 m | 208.5 m | SEC (XBRL)· 24 Feb 2026verified |
| Interest expense | 28.6 m | 24.2 m | 18.8 m | 23.8 m | 17.5 m | 14.6 m | SEC (XBRL)· 24 Feb 2026verified |
| Pre-tax income | -36.9 m | 37.4 m | 104.7 m | 173.4 m | 191.8 m | 215.1 m | SEC (XBRL)· 24 Feb 2026verified |
| Income tax | — | 2.8 m | -76.8 m | 44.5 m | 46.3 m | 56.4 m | SEC (XBRL)· 24 Feb 2026verified |
| Net income | -36.9 m | 34.6 m | 181.5 m | 128.9 m | 145.5 m | 158.7 m | SEC (XBRL)· 24 Feb 2026verified |
| Diluted EPS | -2.48 | 0.58 | 2.97 | 2.13 | 2.51 | 2.71 | SEC (XBRL)· 24 Feb 2026verified |
| Weighted average diluted shares | 25.8 m | 59.2 m | 61.1 m | 60.4 m | 57.9 m | 58.5 m | SEC (XBRL)· 24 Feb 2026verified |
Balance sheet · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Cash | 228.6 m | 234.3 m | 243.8 m | 311.7 m | 453.0 m | 752.5 m | SEC (XBRL)· 24 Feb 2026verified |
| Receivables | 22.2 m | 34.8 m | 54.7 m | 74.1 m | 83.0 m | 96.8 m | SEC (XBRL)· 24 Feb 2026verified |
| Inventories | 3.8 m | 4.4 m | 4.3 m | 5.4 m | 7.2 m | 5.4 m | SEC (XBRL)· 24 Feb 2026verified |
| Current assets | 262.9 m | 284.4 m | 400.3 m | 451.1 m | 579.3 m | 907.0 m | SEC (XBRL)· 24 Feb 2026verified |
| Property, plant & equipment, net | 938.0 k | 820.0 k | 573.0 k | 371.0 k | 1.3 m | — | SEC (XBRL)· 25 Feb 2025verified |
| Intangibles (excl. goodwill) | 162.3 m | 143.9 m | 161.0 m | 137.1 m | 113.3 m | 89.4 m | SEC (XBRL)· 24 Feb 2026verified |
| Total assets | 427.1 m | 433.4 m | 673.9 m | 811.4 m | 999.2 m | 1.3 bn | SEC (XBRL)· 24 Feb 2026verified |
| Accounts payable | 2.6 m | 1.0 m | 3.8 m | 17.7 m | 13.7 m | 17.7 m | SEC (XBRL)· 24 Feb 2026verified |
| Short-term debt | — | 2.0 m | 2.0 m | 15.0 m | 16.3 m | 20.0 m | SEC (XBRL)· 24 Feb 2026verified |
| Long-term debt | 194.3 m | 190.0 m | 189.6 m | 178.6 m | 163.0 m | 143.7 m | SEC (XBRL)· 24 Feb 2026verified |
| Current liabilities | 134.5 m | 53.8 m | 78.9 m | 163.8 m | 175.1 m | 252.1 m | SEC (XBRL)· 24 Feb 2026verified |
| Total liabilities | 329.9 m | 246.9 m | 271.0 m | 344.5 m | 340.0 m | 401.4 m | SEC (XBRL)· 24 Feb 2026verified |
| Equity | 97.2 m † | 186.5 m † | 402.8 m † | 467.0 m † | 659.2 m † | 870.2 m † | SEC (XBRL)· 24 Feb 2026verified |
† equity attributable to the parent's shareholders: in these years the issuer no longer reports the total including non-controlling interests.
Cash flow · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Operating cash flow | -3.0 m | 98.6 m | 144.5 m | 219.4 m | 219.8 m | 348.2 m | SEC (XBRL)· 24 Feb 2026verified |
| Capex | 2.0 k | 298.0 k | 172.0 k | 312.0 k | 1.2 m | 310.0 k | SEC (XBRL)· 24 Feb 2026verified |
| Free cash flow | -3.0 m ≈ | 98.3 m ≈ | 144.3 m ≈ | 219.1 m ≈ | 218.7 m ≈ | 347.9 m ≈ | SEC (XBRL)· 24 Feb 2026derived |
| Investing cash flow | -2.0 m | -100.3 m | -141.8 m | -46.4 m | -67.5 m | -39.6 m | SEC (XBRL)· 24 Feb 2026verified |
| Financing cash flow | 209.2 m | 7.4 m | 6.8 m | -105.6 m | -11.0 m | -9.0 m | SEC (XBRL)· 24 Feb 2026verified |
| Share repurchases | 167.0 k | — | — | 100.0 m | — | — | SEC (XBRL)· 22 Feb 2024verified |
≈ computed by olivLaw from the reported lines of the same year: Operating cash flow − Capex.
Computed indicators
Growth
Profitability
Returns
Balance sheet
Liquidity
Cash
Efficiency
Market and valuation
1 indicators that do not apply to the sector.
Valuation
olivLaw classification
Score: 82 / 100
A scoring methodology on indicators and valuation, not investment advice.
score >= 65 · margin_of_safety >= 0.15 · agreement in ['high', 'medium']
Closing price
04 Nov 2026Source: olivLaw, closing series
Market cap: 2.0 bn USD
Key indicators
Coverage and freshness
Score by group
- Quality88
- Growth50
- Valuation93
- Balance sheet100
Estimated value range
The combined range = the median of the valid methods' low, central and high values; it is not a probability interval and does not cover every result. Envelope of all methods: 45.26 – 160.04 USD.
Valuation assumptions are editorial choices, not measured; beta is not measured.
Method ranges (USD per share)
— — Mid · ▏ Price
Valuation methods
- DCF (discounted cash flow)105.63 – 160.04 (Mid 126.58)WACC 9.0% · starting FCFF 332.6 m USD · terminal value share of EV 75%The WACC × g sensitivity gives the method's bounds; these are not probabilities.Reverse DCF: no growth between −30% and +40% justifies the price
- Peers: EV/EBITDAunavailable · input data missing
- Peers: P/E45.26 – 132.14 (Mid 88.26)14 companies used · median multiple 29.1x · quartiles 14.9x – 43.6xABBV, ABT, ALNY, AUPH, BMY, JNJ, LLY, NATR, PFE, REGN, RPRX, UTHR, VRTX, ZTS
- Dividend discount (DDM)unavailable · the company pays no dividend: a dividend model needs an explicit initiation assumption
Classification (SIC) comparables group by industry code, not by economic activity; the direct group is an editorial selection by activity. Members' multiples are on their own trailing twelve months, at their own latest close.
Assumptions (illustrative, editorial)
- Risk-free rate
- 4.3%
- Equity risk premium
- 5.0%
- Beta (default)
- 1.00
- Cost of equity
- 9.3%
- Terminal growth
- 2.5%
Factor scorecard
Attractive profile · Score 82/100
| Factor | Value | Score | Weight used |
|---|---|---|---|
| ROIC · Quality | 36.1% | 89 (vs peers) | 15% |
| Net margin · Quality | 18.1% | 74 (vs peers) | 9% |
| FCF conversion · Quality | 180.7% | 100 (on a fixed band) | 9% |
| Revenue CAGR 3Y · Growth | 25.6% | 100 (on a fixed band) | 12% |
| EPS CAGR 3Y · Growth | -3.0% | 0 (on a fixed band) | 12% |
| Net debt / EBITDA · Balance sheet | unavailable | unavailable | — |
| Interest coverage · Balance sheet | 17.0x | 100 (on a fixed band) | 9% |
| Current ratio · Balance sheet | 3.4x | 100 (on a fixed band) | 6% |
| P/E (TTM) · Valuation | 11.4x | 88 (vs peers) | 15% |
| EV/EBITDA · Valuation | unavailable | unavailable | — |
| FCF yield · Valuation | 16.0% | 100 (on a fixed band) | 12% |
| Shareholder yield (distributions) · Returns | unavailable | unavailable | — |
| Payout ratio (FCF) · Returns | unavailable | unavailable | — |
Factors without a value were dropped; the remaining weights were renormalised.
Score groups
- Balance sheet100/100 · 2/3 factors with a value
- Growth50/100 · 2/2 factors with a value
- Quality88/100 · 3/3 factors with a value
- Returns· partialunavailable · 0/2 factors with a value
- Valuation93/100 · 2/3 factors with a value
A «partial» group is computed from under half of its weight or from one factor: it is not a full assessment of the group.
Memo
HARMONY BIOSCIENCES HOLDINGS, INC. (HRMY). Latest full fiscal year: 2025; data up to 2026-09-30.
Figures computed from the financial statements: revenue 868.5 m USD in 2025; YoY growth 21.5%; net margin 18.1%; ROE 18.7%.
The estimated value range is 75.45–146.09 USD per share (median of 2 methods, agreement: high); assumptions are illustrative. Against the central value of 107.42 USD, the price of 34.41 USD leaves a potential of 212.1% (value / price − 1) and a margin of safety of 68.0% (1 − price / value). The range is the median of the methods' low, central and high values, not a probability interval.
olivLaw score 82/100, methodological classification: attractive profile (score, margin of safety and method agreement together; not a judgement of the right price). Groups assessed only in part: returns. Not investment advice.
Text generated deterministically from the figures shown; no language model. Not investment advice.
What supports the thesis
- ROIC: 36.1%
- Net margin: 18.1%
- FCF conversion: 180.7%
- Revenue CAGR 3Y: 25.6%
- Interest coverage: 17.0x
- Current ratio: 3.4x
- P/E (TTM): 11.4x
- FCF yield: 16.0%
- The price is below the estimated value range
What contradicts it
- EPS CAGR 3Y: -3.0%
Not assessed (insufficient data or a ratio without meaning): Net debt / EBITDA, EV/EBITDA, Shareholder yield (distributions), Payout ratio (FCF).
Versus the vertical median
Pharmaceutical Preparations (SIC 2834) · same industry (4-digit SIC) · compared with 39 companies
Multiples and returns vs the median
Price rebased to 100 (monthly, 5 years)
Companies in the vertical
| Market cap | P/E | ROE | Net margin | Revenue YoY | 1A / 3A | |
|---|---|---|---|---|---|---|
| LLYEli Lilly And Company | 1,334.0 bn | 46.0 | 86.1% | 31.9% | +44.7% | +32% / +140% |
| JNJJohnson & Johnson | 665.2 bn | 41.9 | 20.0% | 16.2% | +6.0% | +34% / +79% |
| ONCBeone Medicines Ltd. | 558.4 bn | 869.9 | 14.7% | 10.7% | +40.2% | +11% / +102% |
| ABBVAbbVie Inc. | 521.1 bn | 50.7 | — | 15.7% | +8.6% | +29% / +107% |
| MRKMerck & Co., Inc. | 370.7 bn | 154.7 | 5.1% | 3.6% | +1.3% | +43% / +47% |
| ABTAbbott Laboratories | 200.1 bn | 43.0 | 9.2% | 9.7% | +5.7% | −10% / +11% |
| PFEPfizer Inc | 175.5 bn | 43.9 | 4.4% | 6.3% | −1.6% | +20% / +1% |
| VRTXVertex Pharmaceuticals Inc | 139.2 bn | 35.3 | 20.8% | 30.7% | +8.9% | +27% / +55% |
| BMYBristol-Myers Squibb Company | 131.2 bn | 14.2 | 44.1% | 18.5% | −0.2% | +30% / +30% |
| TEVATeva Pharmaceutical Industries Limited | 48.8 bn | 97.4 | 6.6% | 3.6% | +4.3% | +56% / +326% |
| ZTSZoetis Inc. | 36.9 bn | 14.7 | 64.4% | 27.5% | +2.3% | −30% / −50% |
| ROIVRoivant Sciences Ltd. | 27.6 bn | — | -6.2% | -3,535.0% | −71.6% | +84% / +300% |
| RPRXRoyalty Pharma plc | 26.2 bn | 47.7 | 6.9% | 25.7% | +5.1% | +69% / +150% |
| UTHRUnited Therapeutics Corporation | 25.9 bn | 23.0 | 19.1% | 38.6% | +10.6% | +25% / +154% |
| INSMInsmed Inc | 24.1 bn | — | -72.5% | -39.9% | +66.7% | −47% / +340% |
| VTRSViatris Inc. | 22.1 bn | — | -23.6% | -23.9% | −3.0% | +80% / +109% |
| ALNYAlnylam Pharmaceuticals, Inc. | 21.6 bn | 8.1 | 126.6% | 52.8% | +65.2% | −64% / −4% |
| ORKAOruka Therapeutics, Inc. | 6.7 bn | — | -18.2% | — | unavailable | +237% / +364% |
| IONSIonis Pharmaceuticals, Inc. | 6.7 bn | — | -105.5% | -64.7% | +33.8% | −51% / −19% |
| IDYAIDEAYA Biosciences, Inc. | 3.1 bn | — | -38.5% | -1,149.6% | +3,024.4% | −9% / +3% |
| RADXRadiopharm Theranostics Limited | 3.1 bn | — | -109.2% | -1,055.3% | +1,114.3% | −81% / unavailable |
| AUPHAurinia Pharmaceuticals Inc. | 2.3 bn | 7.5 | 61.4% | 97.7% | +20.4% | +6% / +98% |
| HRMYHarmony Biosciences Holdings, Inc. | 2.0 bn | 11.4 | 18.7% | 18.1% | +21.5% | +12% / +33% |
| QUREuniQure N.V. | 1.6 bn | — | -89.0% | -1,154.8% | −40.6% | −16% / +240% |
| URGNUroGen Pharma Ltd. | 1.4 bn | — | — | -26.3% | +21.4% | −0% / +118% |
1- and 3-year price returns: for HRMY from daily closes (the same as the performance table), for the other companies from month-end closes.
olivLaw engine forecast
The world engine ran after the company's latest material disclosure. Probabilities are of TOUCHING a level within the horizon (not closing there) and sit next to the random walk (p_rw), the no-information benchmark.
The engine has no published run for this company yet.
Valuation scenarios (editable assumptions)
Illustrative scenarios
Illustrative: not forecasts and without probabilities. Each case is one coherent set of assumptions, computed on today's figures.
Estimated price (USD)
| Estimated price | Bear | Base | Bull |
|---|---|---|---|
| 1 years | 22.59 Total return -34% · Per year -34% | 39.75 Total return 16% · Per year 16% | 59.63 Total return 73% · Per year 73% |
| 3 years | 26.79 Total return -22% · Per year -8% | 52.57 Total return 53% · Per year 15% | 85.87 Total return 150% · Per year 36% |
| 5 years | 31.78 Total return -8% · Per year -2% | 69.53 Total return 102% · Per year 15% | 123.65 Total return 259% · Per year 29% |
- Exit P/E± 13.14
- Net margin± 9.20
- Annual revenue growth± 6.86
- Annual dilution± 0.77
AI analysis
AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.
Possibly outdated: the newest document it read is from 04 Aug 2026; since then the company filed 8-K (04 Nov 2026 · results), 10-Q (04 Nov 2026).
In brief
Harmony Biosciences is a neuroscience company focused on rare neurological diseases, with its main product WAKIX (pitolisant) for narcolepsy generating net product revenue of 868.5 million USD in fiscal 2025 1. In the second quarter of 2026 revenue rose 30% year over year, and the company reiterated its 2026 WAKIX guidance of 1.0 to 1.04 billion USD 3, so dependence on a single product and its trajectory remain central to the analysis.
SWOT
Strengths
- Differentiated, first-in-class non-stimulant product, not scheduled as a controlled substance, with demonstrated commercial momentum in revenue growth 13.
- Solid liquidity that allows internal development of the portfolio without immediate reliance on outside capital 3.
- Diversified pipeline across several indications and formulations, which reduces dependence on a single indication 13.
Weaknesses
Opportunities
Risks
- Dependence on WAKIXhigh
Revenue depends almost entirely on WAKIX, so any decline in sales or market acceptance would directly affect financial results 1.
- Dependence on the Bioprojet licensehigh
Rights to pitolisant come from a license with Bioprojet, and termination of that agreement could seriously affect development and commercialization 1.
- Patent litigation and generic competitionmedium
Proceedings with generic makers may influence when exclusivity ends, and the outcome is uncertain 3.
- Pricing and regulatory pressuremedium
Public and political pressure on orphan drug prices could lead to price cuts or higher reimbursement costs 1.
Investment thesis
What would need to be true (bull case)
What would break the thesis
- Near-total dependence on a single product means any pressure on WAKIX would directly affect company results 1.
- Failure of earlier clinical studies shows that new indications might not be approved, which would limit franchise extension 1.
- Generic competition and orphan drug pricing rules could reduce revenue if they intensify 13.
What to watch
- FDA decision on Pitolisant GRApril 1, 2027
- Topline data from the TEMPO (PWS) study and from the LIGHTHOUSE and ARGUS trialsmid-2027
- Delivery of the 2026 WAKIX net revenue guidance of 1.0 to 1.04 billion USD2026
Products, market & competition
AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.
Possibly outdated: the newest document it read is from 04 Aug 2026; since then the company filed 8-K (04 Nov 2026 · results), 10-Q (04 Nov 2026).
The business
Harmony Biosciences describes its activity as a differentiated neuroscience company with a portfolio of treatments for rare neurological diseases, grouped into sleep/wake, rare epilepsy and neurobehavioral franchises 1. Its lead product WAKIX (pitolisant), licensed from Bioprojet, is approved by the FDA for excessive daytime sleepiness and cataplexy in narcolepsy and is the only FDA-approved narcolepsy treatment not scheduled by the DEA 1. The company is also developing other pitolisant indications such as Prader-Willi syndrome and myotonic dystrophy type 1, plus new formulations, and through the Epygenix acquisition added EPX-100 for rare epilepsies 1.
In the second quarter of 2026 operating expenses fell year over year, helped by a 2025 upfront payment and a 2025 settlement charge that had no equivalent in the current period, while sales and marketing spending rose with field expansion 3. The company reports a solid liquidity position that supports internal development without immediate reliance on outside financing 3.
Segments
Sleep/wake (WAKIX and pitolisant)
This segment generates almost all of the company's revenue. WAKIX brought in 868.5 million USD in fiscal 2025 1 and 261.3 million USD in the second quarter of 2026 3. Development focuses on the Pitolisant GR formulation, with an FDA target action date of April 1, 2027, and Pitolisant HD, which is in Phase 3 3, plus the Prader-Willi indication, with topline data expected in mid-2027 3.
Market context
The U.S. narcolepsy market had an approximate net sales value of 3.1 billion USD in 2025 and is expected to grow on the back of new therapies with novel mechanisms, more frequent diagnosis and population growth 1. The company estimates approximately 80,000 diagnosed narcolepsy patients in the U.S. 3, and the average number of patients on WAKIX was about 8,500 in 2025 1, rising to 8,950 in the second quarter of 2026 3.
Market access and pricing remain sensitive: the company notes downward pricing pressure from payors and public debate over orphan drug prices, which could limit revenue if it intensifies 1. Patent protection and generic exclusion are also an important factor for the period after 2030 3.
Trends
- Growing WAKIX adoptiontailwind
The number of unique prescribers and patients on WAKIX has grown steadily since its 2019 launch, and the company has expanded sales and reimbursement support teams, which could sustain further growth 13.
- Pricing pressure on orphan drugsheadwind
Public and political debate over orphan drug prices could lead to tighter regulation or price reductions, which would affect revenue if it materialises 1.
- Loss of exclusivity and patent litigationmixed
WAKIX exclusivity is estimated through March 2030, including pediatric exclusivity, while litigation with generic filers is ongoing. The outcome could influence the timing of generic competition 3.
Competitive position
WAKIX competes in a market with other narcolepsy treatments, including stimulants and modafinil, which are often prescribed first 1. The company notes WAKIX did not demonstrate non-inferiority to modafinil, which could lead physicians to choose alternatives 1. Over the longer term, generic competition and new orexin agonist classes will matter 13.
As a developer in new classes, Harmony also faces competition in the orexin agonist area, where other developers in clinical stages could reach the market first 3. The company's advantage could lie in the non-controlled status of WAKIX and its safety profile 1.
- Modafinil (reference generic treatment)
Frequently prescribed stimulant-type treatment for excessive daytime sleepiness; the company notes WAKIX did not show non-inferiority to it 1.
- Stimulants and fast-acting wake-promoting agents
Class of fast-acting treatments often prescribed in narcolepsy, with abuse potential, in contrast to the non-stimulant profile of WAKIX 1.
- Oxybate treatments
Common narcolepsy treatments with which WAKIX was studied in combination without clinically relevant pharmacokinetic effects 1.
Links, dependencies and risks
Who the company is tied to, from its own SEC filings (customers, suppliers, production, partners, competitors, countries, regulation), from the 5 %+ holders' statements (13D/13G) and from what other companies say about it. Click a node for its evidence; on a listed company the graph moves to it.
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News & filings
In the press
- Behind the Veil of Religious Harmony in CambodiaThe Diplomat (Asia geopolitics) · 19 Oct 2026 · EN
- Bangladesh celebrates Durga Puja under heavy security; PM and President stress communal harmonyThe Hindu — International · 17 Oct 2026 · EN
- How to protect your garden and live in harmony with possumsSurge — GDELT DOC · 02 Oct 2026 · RO
- (3rd LD) (Asiad) Competition begins with celebration of host city's hospitality, harmony in AsiaYonhap News (KR, EN) · 19 Sept 2026 · EN
- (2nd LD) (Asiad) Competition begins with celebration of host city's hospitality, harmony in AsiaYonhap News (KR, EN) · 19 Sept 2026 · EN
- (LEAD) (Asiad) Competition begins with celebration of host city's hospitality, harmony in AsiaYonhap News (KR, EN) · 19 Sept 2026 · EN
- (Asiad) Competition begins with celebration of host city's hospitality, harmony in AsiaYonhap News (KR, EN) · 19 Sept 2026 · EN
- New Singapore racial harmony law to take effect Sep 15; inaugural presidential council appointedCNA (Channel NewsAsia) · 14 Sept 2026 · EN
- Chiang Mai district seeks harmony between 'digital nomads' and localsNikkei Asia · 06 Sept 2026 · EN
- Super-precise optical clocks in four nations tick in harmonyNature · 04 Sept 2026 · EN
- Exploit Published for Fresh Cleo Harmony VulnerabilitySecurityWeek · 02 Sept 2026 · EN
- In China, the new and the old worlds live in harmonyThe Hindu — International · 29 Aug 2026 · EN
- Harmony Explained: Progress Towards a Scientific Theory of Music (2012)Hacker News · 28 Jul 2026 · EN
- Xi Jinping’s Temple of Heaven Message to Trump: Chinese Modernization, Harmony, and the Global SouthModern Diplomacy · 24 May 2026 · RO
The latest news item in our archive is from 19 Oct 2026; the newest SEC filing is from 04 Nov 2026. The press archive comes from the RSS feeds we follow and does not necessarily cover the latest event — the filings alongside do.
SEC filings
- Quarterly report04 Nov 2026
- Current report04 Nov 2026Results of operations · Regulation FD disclosure · Financial statements and exhibits
- Current report (amendment)30 Oct 2026Departure or appointment of officers · Financial statements and exhibits
- Current report13 Oct 2026Departure or appointment of officers · Regulation FD disclosure · Financial statements and exhibits
- Quarterly report04 Aug 2026
- Current report04 Aug 2026Results of operations · Regulation FD disclosure · Financial statements and exhibits
- Current report16 Jul 2026Results of operations · Departure or appointment of officers · Regulation FD disclosure · Financial statements and exhibits
- Current report14 May 2026Shareholder vote
- Current report07 May 2026Results of operations · Regulation FD disclosure · Financial statements and exhibits
- Quarterly report07 May 2026
Sources
- [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / Harmony Biosciences Holdings, Inc. · 24 Feb 2026
- [2] Form 10-Q, quarter ended 2026-06-30 · SEC / Harmony Biosciences Holdings, Inc. · 04 Aug 2026
- [3] Form 8-K, results release (exhibit 99.1) · SEC / Harmony Biosciences Holdings, Inc. · 04 Aug 2026
Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.