Harmony Biosciences(HRMY)
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Harmony Biosciences(HRMY) - 2025 Q2 - Quarterly Results
2025-08-05 12:00
Exhibit 99.1 HARMONY BIOSCIENCES REPORTS STRONG Q2 2025 FINANCIAL RESULTS AND REAFFIRMS 2025 REVENUE GUIDANCE; ON TRACK TO ANNOUNCE FRAGILE X TOPLINE DATA FROM PHASE 3 REGISTRATIONAL TRIAL IN Q3 2025 Conference Call and Webcast to be Held Today at 8:30 a.m. ET PLYMOUTH MEETING, Pa., August 5, 2025 /Business Wire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced plans to announce topline data from its phase 3 registrational clinical trial of ZYN002 in Fragile X syndrome in Q3 2025. The co ...
Harmony Biosciences Holdings, Inc. (HRMY) Earnings Expected to Grow: What to Know Ahead of Next Week's Release
ZACKS· 2025-07-29 15:01
Company Overview - Harmony Biosciences Holdings, Inc. (HRMY) is expected to report a year-over-year increase in earnings driven by higher revenues for the quarter ended June 2025, with a consensus EPS estimate of $0.82, reflecting a +310% change [1][3] - Revenue expectations stand at $203.38 million, which is a 17.7% increase from the same quarter last year [3] Earnings Expectations - The earnings report is anticipated to be released on August 5, and the stock may rise if actual results exceed expectations; conversely, a miss could lead to a decline [2] - The consensus EPS estimate has been revised down by 5.2% over the last 30 days, indicating a bearish sentiment among analysts [4] Earnings Surprise Prediction - The Most Accurate Estimate for Harmony Biosciences is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -2.31%, which complicates predictions of an earnings beat [12] - Despite the negative Earnings ESP, the company holds a Zacks Rank of 2 (Buy), suggesting potential for positive performance [12] Historical Performance - In the last reported quarter, Harmony Biosciences had an earnings surprise of +32.20%, with actual earnings of $0.78 per share compared to an expected $0.59 [13] - The company has successfully beaten consensus EPS estimates in the last four quarters [14] Industry Context - In the broader Zacks Medical - Biomedical and Genetics industry, Vertex Pharmaceuticals (VRTX) is also expected to report strong earnings, with an EPS estimate of $4.24, reflecting a +133.1% year-over-year change and revenues of $2.89 billion, up 9.2% [18][19] - Vertex has an Earnings ESP of +1.55% and a Zacks Rank of 3 (Hold), indicating a likelihood of beating the consensus EPS estimate [19][20]
5 High Earnings Yield Stocks to Tap Into Value Investing Gains
ZACKS· 2025-07-22 13:56
Core Insights - Value investing focuses on identifying stocks trading below their intrinsic value, allowing investors to benefit as market prices align with true company value over time [1] - Earnings yield, calculated as earnings per share divided by stock price, is a useful metric for identifying undervalued stocks, with a higher yield indicating potential undervaluation [2][4] - A screening criterion of an earnings yield greater than 10% is established, alongside other parameters like estimated EPS growth and average daily volume [6][7] Company Highlights - IAMGOLD Corporation (IAG) is a gold exploration and mining company with projected earnings growth of 44% and 40% for 2025 and 2026, respectively, and currently holds a Zacks Rank 1 [9] - Plains GP Holdings (PAGP) is involved in crude oil and refined products transportation, with earnings growth estimates of 206% and 24% for 2025 and 2026, respectively, also holding a Zacks Rank 1 [10][11] - Hope Bancorp (HOPE) provides commercial banking services, with earnings growth estimates of 12% and 40% for 2025 and 2026, and holds a Zacks Rank 1 [12] - CommScope Holding Company, Inc. (COMM) offers communication network infrastructure solutions, with an extraordinary earnings growth estimate of 3,167% for 2025 and 28% for 2026, holding a Zacks Rank 2 [13] - Harmony Biosciences Holdings Inc. (HRMY) focuses on therapies for rare neurological disorders, with earnings growth estimates of 22% and 32% for 2025 and 2026, and holds a Zacks Rank 2 [14]
Why Harmony Biosciences (HRMY) is Poised to Beat Earnings Estimates Again
ZACKS· 2025-07-17 17:11
Core Insights - Harmony Biosciences Holdings, Inc. has consistently beaten earnings estimates, with an average surprise of 23.53% over the last two quarters [1][5] - For the most recent quarter, the company reported earnings of $0.59 per share against an expectation of $0.78, resulting in a surprise of 32.20% [2] - The previous quarter saw Harmony Biosciences exceed the consensus estimate of $0.74 per share by reporting $0.85, achieving a surprise of 14.86% [2] Earnings Estimates and Predictions - Recent estimates for Harmony Biosciences have been increasing, indicating a positive outlook for future earnings [5] - The Zacks Earnings ESP for the company is currently +19.75%, suggesting analysts are optimistic about its earnings prospects [8] - A positive Earnings ESP combined with a Zacks Rank of 2 (Buy) indicates a strong possibility of another earnings beat [8] Statistical Insights - Stocks with a positive Earnings ESP and a Zacks Rank of 3 (Hold) or better have a nearly 70% chance of producing a positive surprise [6] - The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate, reflecting the latest analyst revisions [7] - It is crucial to check a company's Earnings ESP before quarterly releases to enhance the likelihood of successful investment decisions [10]
Harmony Biosciences (HRMY) Conference Transcript
2025-07-17 15:00
Harmony Biosciences Conference Summary Company Overview - **Company**: Harmony Biosciences (HRMY) - **Industry**: Biotechnology, specifically focusing on treatments for rare neurological disorders, including narcolepsy and epilepsy Key Points and Arguments Commercial Performance - **Wakix Revenue Projections**: Expected to generate revenues of **$714 million** in 2024 and **$870 million** in 2025, with potential to exceed **$1 billion** by 2030 [1][4] - **Patient Growth**: Achieved **7,200 average patients** on therapy as of Q1 2025, with expectations to approach **8,000 patients** by year-end [41][42] - **Market Dynamics**: Wakix is the only FDA-approved nonscheduled treatment for narcolepsy, leading to high physician awareness and steady patient additions [39][40] Pipeline Development - **Late-Stage Pipeline**: Harmony has **eight assets** across **13 development programs**, with up to **six in Phase III** by year-end [5][6] - **ZYN-002 for Fragile X Syndrome**: Anticipated top-line data in Q2 2025, with potential to be the first approved treatment for any symptom domains in Fragile X syndrome [10][18] - **EPX-100 for Epilepsy**: Two pivotal Phase III studies ongoing for Dravet syndrome and Lennox Gastaut syndrome, with top-line data expected in 2026 [72][73] Financial Position - **Strong Balance Sheet**: Over **$600 million** in cash, allowing for flexibility in business development and pipeline expansion [5][25] - **Capital Allocation Plans**: Focus on building out the pipeline through early-stage and potentially on-market assets in the neuro space [25][27] Life Cycle Management - **New Formulations for Wakix**: - **Gastro Resistant (GR)**: Expected PDUFA in 2026, designed to address GI symptoms common in narcolepsy patients [46][47] - **High Dose (HD)**: Targeting fatigue in narcolepsy patients, with PDUFA in 2028 [48][49] Competitive Landscape - **Orexin Receptor Agonist Program**: Positioned as a potent option in the narcolepsy treatment landscape, with plans to initiate first-in-human studies later in 2025 [60][61] - **Market Strategy**: Harmony's unique commercial model and established relationships with healthcare providers are expected to support the successful launch of new products [66][67] Strategic Collaborations - **Research Collaboration with Cirque Biosciences**: Focused on regenerative therapies for neurological disorders, enhancing Harmony's pipeline with innovative approaches [29][30] Additional Important Insights - **Unmet Needs in Epilepsy**: The epilepsy market has significant unmet needs, with many patients on multiple medications experiencing inadequate control of seizures [70][71] - **Differentiation in Safety and Tolerability**: EPX-100 is expected to offer a favorable safety profile without the need for regular monitoring, addressing a critical gap in current epilepsy treatments [74][75] Conclusion - Harmony Biosciences is positioned for significant growth with a robust pipeline and strong commercial performance in the narcolepsy market. The company is focused on advancing late-stage programs and addressing unmet medical needs in rare neurological disorders, aiming for multiple product launches in the coming years [80][81]
3 Reasons Growth Investors Will Love Harmony Biosciences (HRMY)
ZACKS· 2025-07-15 17:46
Core Viewpoint - Investors are seeking growth stocks that can deliver above-average growth and exceptional returns, but identifying such stocks is challenging due to inherent volatility and risks [1] Group 1: Growth Stock Identification - The Zacks Growth Style Score system aids in identifying promising growth stocks by analyzing real growth prospects beyond traditional metrics [2] - Harmony Biosciences Holdings, Inc. (HRMY) is highlighted as a recommended stock with a favorable Growth Score and a top Zacks Rank [2] Group 2: Earnings Growth - Earnings growth is crucial for investors, with double-digit growth being a strong indicator of future stock price gains [3] - Harmony Biosciences has a historical EPS growth rate of 11.7%, with projected EPS growth of 22.5% this year, surpassing the industry average of 19.1% [4] Group 3: Cash Flow Growth - High cash flow growth is essential for growth-oriented companies, allowing them to fund new projects without external financing [5] - Harmony Biosciences has a year-over-year cash flow growth of 10%, significantly higher than the industry average of -4.7% [5] - The company's annualized cash flow growth rate over the past 3-5 years is 25.7%, compared to the industry average of 4.1% [6] Group 4: Earnings Estimate Revisions - Positive trends in earnings estimate revisions correlate strongly with near-term stock price movements [7] - Current-year earnings estimates for Harmony Biosciences have been revised upward, with the Zacks Consensus Estimate increasing by 0.2% over the past month [8] Group 5: Overall Assessment - Harmony Biosciences has achieved a Growth Score of B and a Zacks Rank 2, indicating positive earnings estimate revisions and potential for outperformance [9]
HRMY vs. ILMN: Which Stock Should Value Investors Buy Now?
ZACKS· 2025-07-15 16:41
Core Insights - Harmony Biosciences Holdings, Inc. (HRMY) is currently viewed as a more attractive investment compared to Illumina (ILMN) for those seeking undervalued stocks [1][3][7] Valuation Metrics - HRMY has a forward P/E ratio of 11.28, significantly lower than ILMN's forward P/E of 23.26, indicating HRMY may be undervalued [5] - The PEG ratio for HRMY is 0.48, while ILMN's PEG ratio stands at 1.93, suggesting HRMY has better earnings growth potential relative to its price [5] - HRMY's P/B ratio is 2.76 compared to ILMN's P/B of 6.59, further supporting the notion that HRMY is undervalued [6] Earnings Outlook - HRMY is experiencing an improving earnings outlook, which enhances its attractiveness in the Zacks Rank model [7]
Does Harmony Biosciences (HRMY) Have the Potential to Rally 43.19% as Wall Street Analysts Expect?
ZACKS· 2025-07-15 14:56
Group 1 - Harmony Biosciences Holdings, Inc. (HRMY) shares have increased by 5.5% over the past four weeks, closing at $34.71, with a mean price target of $49.7 indicating a potential upside of 43.2% [1] - The mean estimate consists of 10 short-term price targets with a standard deviation of $11.66, where the lowest estimate is $31.00 (10.7% decline) and the highest is $70.00 (101.7% increase) [2] - Analysts show a consensus that HRMY will report better earnings than previously estimated, which is a positive indicator for potential stock upside [4][11] Group 2 - The Zacks Consensus Estimate for HRMY has increased by 0.2% due to one upward revision in earnings estimates over the last 30 days, with no negative revisions [12] - HRMY holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, suggesting strong potential for near-term upside [13] - While consensus price targets may not be reliable for predicting exact gains, they can provide a directional guide for price movement [14]
Is Harmony Biosciences (HRMY) Stock Undervalued Right Now?
ZACKS· 2025-07-15 14:41
While the proven Zacks Rank places an emphasis on earnings estimates and estimate revisions to find strong stocks, we also know that investors tend to develop their own individual strategies. With this in mind, we are always looking at value, growth, and momentum trends to discover great companies.Considering these trends, value investing is clearly one of the most preferred ways to find strong stocks in any type of market. Value investors rely on traditional forms of analysis on key valuation metrics to fi ...
Harmony Biosciences (HRMY) Earnings Call Presentation
2025-07-03 09:14
Financial Performance & Growth - Harmony Biosciences achieved Q1 2025 net product revenue of $184.7 million, a 20% increase compared to $154.6 million in Q1 2024[10, 59] - The company reiterates its full-year 2025 revenue guidance of $820-$860 million[12] - Harmony Biosciences has over $600 million in cash, cash equivalents, and investments[5, 58] - WAKIX net revenue grew from $160 million in 2020 to $715 million in 2024[7] Pipeline Development & Catalysts - The company anticipates multiple milestones in 2025, with 6 Phase 3 development programs expected by year-end[62] - Topline data from the Phase 3 RECONNECT study of ZYN002 in Fragile X Syndrome is expected in Q3 2025[20, 22] - Phase 3 registrational trials of Pitolisant HD in narcolepsy and idiopathic hypersomnia are scheduled to begin in Q4 2025[20, 22, 41] - Preclinical data for BP1.15205, a potential best-in-class orexin-2 agonist, will be presented at SLEEP 2025 in June[20, 22, 24] Strategic Positioning & Market Opportunity - WAKIX is considered a potential $1B+ opportunity in narcolepsy alone[8, 12, 47] - The company is pursuing utility patents for pitolisant GR and pitolisant HD, potentially extending patent protection until 2044[20] - The company aims to establish a leadership position in CNS with a potential $3B+ opportunity[64]