Harmony Biosciences Reports $868.5 Million Revenue for 2025, Guidance for 2026 Exceeds $1 Billion
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
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Should l Buy HRMY?
Source: Newsfilter
- Significant Revenue Growth: Harmony Biosciences reported net product revenue of $868.5 million for 2025, reflecting a 22% year-over-year increase, driven by sustained demand for WAKIX among approximately 80,000 diagnosed narcolepsy patients, reinforcing the company's profitability and market position in the biotech sector.
- Optimistic Future Outlook: The company reiterated its 2026 WAKIX net revenue guidance of $1.0 to $1.04 billion, indicating a trajectory towards blockbuster status, showcasing the strong market potential and ongoing momentum of the Pitolisant franchise.
- Increased R&D Investment: Research and development expenses reached $49.9 million in Q4 2025, a 44% increase, demonstrating the company's commitment to advancing new drug development and expanding its product pipeline, particularly in the field of central nervous system disorders.
- Market Expansion Strategy: Harmony plans to broaden the indications for Pitolisant into larger CNS conditions, which is expected to provide new revenue growth drivers in the future, especially in the management of fatigue, thereby enhancing its competitive edge in the market.
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Analyst Views on HRMY
Wall Street analysts forecast HRMY stock price to rise
6 Analyst Rating
5 Buy
0 Hold
1 Sell
Moderate Buy
Current: 29.160
Low
32.00
Averages
43.83
High
55.00
Current: 29.160
Low
32.00
Averages
43.83
High
55.00
About HRMY
Harmony Biosciences Holdings, Inc. is a pharmaceutical company. It is focused on developing and commercializing therapies for patients living with rare neurological diseases as well as patients living with other neurological diseases who have unmet medical needs. Its product, WAKIX (pitolisant), is a first-in-class molecule with a novel mechanism of action designed to enhance histamine signaling in the brain by binding to H3 receptors. WAKIX was developed for the treatment of excessive daytime sleepiness (EDS) in pediatric patients, six years and older, with narcolepsy. HBS-102, an investigational compound, which is a melanin-concentrating hormone receptor 1 (MCHR1) antagonist. ZYN002 is an investigational drug product in development for the potential treatment of behavioral symptoms associated with Fragile X syndrome (FXS) and 22q11.2 deletion syndrome (22q). It also focused on the rare epilepsy franchise in its expanding late-stage pipeline of CNS assets: EPX-100 and EPX-200.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Harmony Biosciences to Announce Q4 Earnings on February 24
- Earnings Announcement Date: Harmony Biosciences Holdings, Inc. is set to release its Q4 2023 earnings on February 24 before market open, with a consensus EPS estimate of $1.07, reflecting a slight decline of 0.9% year-over-year, indicating potential challenges in profitability.
- Revenue Growth Expectations: The revenue estimate for the quarter stands at $240.32 million, representing a robust year-over-year growth of 19.4%, suggesting strong market demand and sales performance that could lay the groundwork for future growth.
- Historical Performance Review: Over the past two years, Harmony Biosciences has exceeded EPS estimates 75% of the time and revenue estimates 63% of the time, indicating a relatively stable financial performance that enhances investor confidence.
- Expectation Revision Dynamics: In the last three months, EPS estimates have seen two upward revisions and one downward revision, while revenue estimates have experienced seven upward revisions with no downward adjustments, reflecting analysts' optimistic outlook on the company's future performance, which may influence stock price movements.
See More
Harmony Biosciences Reports $868.5 Million Revenue for 2025, Guidance for 2026 Exceeds $1 Billion
- Significant Revenue Growth: Harmony Biosciences reported net product revenue of $868.5 million for 2025, reflecting a 22% year-over-year increase, driven by sustained demand for WAKIX among approximately 80,000 diagnosed narcolepsy patients, reinforcing the company's profitability and market position in the biotech sector.
- Optimistic Future Outlook: The company reiterated its 2026 WAKIX net revenue guidance of $1.0 to $1.04 billion, indicating a trajectory towards blockbuster status, showcasing the strong market potential and ongoing momentum of the Pitolisant franchise.
- Increased R&D Investment: Research and development expenses reached $49.9 million in Q4 2025, a 44% increase, demonstrating the company's commitment to advancing new drug development and expanding its product pipeline, particularly in the field of central nervous system disorders.
- Market Expansion Strategy: Harmony plans to broaden the indications for Pitolisant into larger CNS conditions, which is expected to provide new revenue growth drivers in the future, especially in the management of fatigue, thereby enhancing its competitive edge in the market.
See More
Harmony Biosciences Downgraded, Shares Drop 10%
- Rating Downgrade Impact: Deutsche Bank and Truist downgraded Harmony Biosciences from buy to hold, resulting in a ~10% drop in stock price during Monday trading, reflecting market concerns about the company's future performance.
- Intellectual Property Case Risk: Analysts highlighted that Harmony's main drug, Wakix (pitolisant), faces an intellectual property case with AET Pharma, with indications that the judge may be siding against Harmony; if exclusivity is lost, generics could enter the market as early as this year instead of 2030.
- Market Outlook Uncertainty: Truist's analyst noted that the judge's initial comments following the trial do not bode well for HRMY, increasing uncertainty around the durability of the Wakix franchise, which could impact the company's overall valuation.
- Single Value Driver: As Wakix remains the sole value driver for Harmony, concerns about its future prompted the downgrade, indicating a lack of confidence in the company's profitability moving forward.
See More
Harmony Biosciences Receives FDA Approval for Wakix Label Expansion
- Label Expansion: Harmony Biosciences announced that its sleep disorder therapy Wakix has received FDA approval for use in children aged six and older with narcolepsy, marking a strategic expansion into the pediatric market.
- Drug Background: Wakix (pitolisant) was initially approved by the FDA in 2019 for treating excessive daytime sleepiness in adults with narcolepsy and was further expanded in 2020 to include adults with cataplexy, indicating its broad therapeutic potential.
- Market Outlook: This approval not only opens the pediatric market for Harmony Biosciences but also has the potential to enhance the market value of pitolisant through the development of next-generation formulations, strengthening the company's position in a competitive pharmaceutical landscape.
- CEO's Vision: CEO Jeffrey Dayno remarked that the company is focused on further growing and expanding the value of pitolisant through additional indications and new formulations, reflecting a positive outlook on future market opportunities.
See More
Harmony Receives FDA Approval for Wakix in Pediatric Narcolepsy
- FDA Approval Milestone: Harmony Biosciences announced that its Wakix tablets have received FDA approval for treating narcolepsy in pediatric patients aged 6 and older, marking an expansion of the drug's application in the pediatric population and expected to significantly enhance the company's competitiveness in the pediatric neurological disorder market.
- Positive Market Reaction: Following the FDA approval announcement, Harmony's stock (HRMY) rose by 2% on Tuesday, reflecting investor optimism regarding the company's future growth potential, particularly in the unique pediatric narcolepsy treatment space.
- Analyst Ratings Optimistic: According to Koyfin data, 8 out of 11 analysts covering the stock rate it as 'Buy' or higher, indicating strong market confidence in Harmony's future performance, with an average price target of $46.73, suggesting a potential upside of approximately 30%.
- Unique Treatment Option: Wakix is now the first and only FDA-approved non-controlled substance treatment for both pediatric and adult narcolepsy patients with or without cataplexy, a significant distinction that enhances its clinical utility and may drive broader market acceptance.
See More
Harmony Biosciences CFO Executes Stock Sale
- Executive Stock Sale: Sandip Kapadia, CFO of Harmony Biosciences, sold 3,746 shares on January 26, 2026, for approximately $139,171, indicating his market activity, although this transaction is significantly below his recent median sale size of 13,494 shares.
- Holding Changes: Following this transaction, Kapadia's direct holdings decreased from over 127,000 shares in March 2023 to 24,521 shares, reflecting a potential decline in confidence regarding the company's future, yet he still retains shares valued at approximately $916,105.
- Strong Financial Performance: Harmony Biosciences has shown robust financial results in FY 2025, with expectations to exceed $1 billion in revenue from WAKIX alone by the end of 2026, highlighting the company's market potential and competitive edge in rare neurological disease treatments.
- Long-Term Growth Outlook: The company is also advancing other medications, which are projected to generate sufficient revenue to support operations well into 2040, particularly against the backdrop of a 10% expected growth in 2025, reinforcing its position in the biomedical sector.
See More
Harmony Biosciences to Announce Q4 Earnings on February 24
- Earnings Announcement Date: Harmony Biosciences Holdings, Inc. is set to release its Q4 2023 earnings on February 24 before market open, with a consensus EPS estimate of $1.07, reflecting a slight decline of 0.9% year-over-year, indicating potential challenges in profitability.
- Revenue Growth Expectations: The revenue estimate for the quarter stands at $240.32 million, representing a robust year-over-year growth of 19.4%, suggesting strong market demand and sales performance that could lay the groundwork for future growth.
- Historical Performance Review: Over the past two years, Harmony Biosciences has exceeded EPS estimates 75% of the time and revenue estimates 63% of the time, indicating a relatively stable financial performance that enhances investor confidence.
- Expectation Revision Dynamics: In the last three months, EPS estimates have seen two upward revisions and one downward revision, while revenue estimates have experienced seven upward revisions with no downward adjustments, reflecting analysts' optimistic outlook on the company's future performance, which may influence stock price movements.
See More
Harmony Biosciences Reports $868.5 Million Revenue for 2025, Guidance for 2026 Exceeds $1 Billion
- Significant Revenue Growth: Harmony Biosciences reported net product revenue of $868.5 million for 2025, reflecting a 22% year-over-year increase, driven by sustained demand for WAKIX among approximately 80,000 diagnosed narcolepsy patients, reinforcing the company's profitability and market position in the biotech sector.
- Optimistic Future Outlook: The company reiterated its 2026 WAKIX net revenue guidance of $1.0 to $1.04 billion, indicating a trajectory towards blockbuster status, showcasing the strong market potential and ongoing momentum of the Pitolisant franchise.
- Increased R&D Investment: Research and development expenses reached $49.9 million in Q4 2025, a 44% increase, demonstrating the company's commitment to advancing new drug development and expanding its product pipeline, particularly in the field of central nervous system disorders.
- Market Expansion Strategy: Harmony plans to broaden the indications for Pitolisant into larger CNS conditions, which is expected to provide new revenue growth drivers in the future, especially in the management of fatigue, thereby enhancing its competitive edge in the market.
See More
Harmony Biosciences Downgraded, Shares Drop 10%
- Rating Downgrade Impact: Deutsche Bank and Truist downgraded Harmony Biosciences from buy to hold, resulting in a ~10% drop in stock price during Monday trading, reflecting market concerns about the company's future performance.
- Intellectual Property Case Risk: Analysts highlighted that Harmony's main drug, Wakix (pitolisant), faces an intellectual property case with AET Pharma, with indications that the judge may be siding against Harmony; if exclusivity is lost, generics could enter the market as early as this year instead of 2030.
- Market Outlook Uncertainty: Truist's analyst noted that the judge's initial comments following the trial do not bode well for HRMY, increasing uncertainty around the durability of the Wakix franchise, which could impact the company's overall valuation.
- Single Value Driver: As Wakix remains the sole value driver for Harmony, concerns about its future prompted the downgrade, indicating a lack of confidence in the company's profitability moving forward.
See More
Harmony Biosciences Receives FDA Approval for Wakix Label Expansion
- Label Expansion: Harmony Biosciences announced that its sleep disorder therapy Wakix has received FDA approval for use in children aged six and older with narcolepsy, marking a strategic expansion into the pediatric market.
- Drug Background: Wakix (pitolisant) was initially approved by the FDA in 2019 for treating excessive daytime sleepiness in adults with narcolepsy and was further expanded in 2020 to include adults with cataplexy, indicating its broad therapeutic potential.
- Market Outlook: This approval not only opens the pediatric market for Harmony Biosciences but also has the potential to enhance the market value of pitolisant through the development of next-generation formulations, strengthening the company's position in a competitive pharmaceutical landscape.
- CEO's Vision: CEO Jeffrey Dayno remarked that the company is focused on further growing and expanding the value of pitolisant through additional indications and new formulations, reflecting a positive outlook on future market opportunities.
See More
Harmony Receives FDA Approval for Wakix in Pediatric Narcolepsy
- FDA Approval Milestone: Harmony Biosciences announced that its Wakix tablets have received FDA approval for treating narcolepsy in pediatric patients aged 6 and older, marking an expansion of the drug's application in the pediatric population and expected to significantly enhance the company's competitiveness in the pediatric neurological disorder market.
- Positive Market Reaction: Following the FDA approval announcement, Harmony's stock (HRMY) rose by 2% on Tuesday, reflecting investor optimism regarding the company's future growth potential, particularly in the unique pediatric narcolepsy treatment space.
- Analyst Ratings Optimistic: According to Koyfin data, 8 out of 11 analysts covering the stock rate it as 'Buy' or higher, indicating strong market confidence in Harmony's future performance, with an average price target of $46.73, suggesting a potential upside of approximately 30%.
- Unique Treatment Option: Wakix is now the first and only FDA-approved non-controlled substance treatment for both pediatric and adult narcolepsy patients with or without cataplexy, a significant distinction that enhances its clinical utility and may drive broader market acceptance.
See More
Harmony Biosciences CFO Executes Stock Sale
- Executive Stock Sale: Sandip Kapadia, CFO of Harmony Biosciences, sold 3,746 shares on January 26, 2026, for approximately $139,171, indicating his market activity, although this transaction is significantly below his recent median sale size of 13,494 shares.
- Holding Changes: Following this transaction, Kapadia's direct holdings decreased from over 127,000 shares in March 2023 to 24,521 shares, reflecting a potential decline in confidence regarding the company's future, yet he still retains shares valued at approximately $916,105.
- Strong Financial Performance: Harmony Biosciences has shown robust financial results in FY 2025, with expectations to exceed $1 billion in revenue from WAKIX alone by the end of 2026, highlighting the company's market potential and competitive edge in rare neurological disease treatments.
- Long-Term Growth Outlook: The company is also advancing other medications, which are projected to generate sufficient revenue to support operations well into 2040, particularly against the backdrop of a 10% expected growth in 2025, reinforcing its position in the biomedical sector.
See More
