Core Viewpoint - Harmony Biosciences received a Refusal to File (RTF) letter from the FDA for pitolisant for excessive daytime sleepiness (EDS) in adult patients with idiopathic hypersomnia (IH), but the company's 2025 net revenue guidance remains unchanged at $820 million to $860 million [1]. Group 1: Company Developments - The CEO of Harmony Biosciences expressed disappointment over the RTF letter but reaffirmed the long-term strategy for pitolisant in IH, with plans to initiate a Phase 3 registrational trial in Q4 2025 and a target PDUFA date in 2028 [2]. - Despite the primary outcome for EDS not reaching statistical significance in the Phase 3 INTUNE Study, open-label phase data indicated that patients experienced improvements on the Epworth Sleepiness Scale that were five times greater than clinically meaningful levels [2]. - Most patients in the long-term extension study achieved normal wakefulness levels and maintained this response beyond one year [3]. Group 2: Financial Performance - In January, Harmony reported preliminary net product revenue for Q4 of approximately $201 million, up from $168.4 million year-over-year, exceeding the consensus estimate of $198.6 million [4]. - The average number of patients on Wakix increased by approximately 300 sequentially to around 7,100 for the quarter ended December 31, 2024 [4]. Group 3: Market Reaction - Following the news, HRMY stock declined by 6.50% to $36.55 [5].

Core Insights - The article compares Harmony Biosciences Holdings, Inc. (HRMY) and BeiGene, Ltd. (ONC) to determine which stock is more attractive to value investors [1] Group 1: Zacks Rank and Earnings Outlook - HRMY has a Zacks Rank of 1 (Strong Buy), indicating a stronger improvement in its earnings outlook compared to ONC, which has a Zacks Rank of 3 (Hold) [3] - The Zacks Rank strategy targets companies with positive earnings estimate revision trends, which is a key factor for value investors [2] Group 2: Valuation Metrics - HRMY has a forward P/E ratio of 12.33, significantly lower than ONC's forward P/E of 410.78, suggesting HRMY is more undervalued [5] - The PEG ratio for HRMY is 0.52, while ONC's PEG ratio is 9.21, indicating HRMY's expected EPS growth rate is more favorable [5] - HRMY's P/B ratio is 3.72, compared to ONC's P/B of 6.54, further supporting HRMY's valuation attractiveness [6] Group 3: Value Grades - HRMY has a Value grade of A, while ONC has a Value grade of D, highlighting HRMY's superior valuation metrics [6] - The combination of Zacks Rank and Style Scores indicates that HRMY is the better option for value investors at this time [6]

Core Viewpoint - Investors are increasingly seeking growth stocks that demonstrate above-average growth potential, with Harmony Biosciences Holdings, Inc. (HRMY) being highlighted as a strong candidate due to its favorable growth metrics and Zacks Rank [2][10]. Group 1: Earnings Growth - Historical EPS growth rate for Harmony Biosciences is 13.5%, but projected EPS growth for this year is expected to be 30.1%, significantly higher than the industry average of 12.3% [4]. - Earnings growth is a critical factor for growth investors, with double-digit growth being a strong indicator of future stock price gains [3]. Group 2: Asset Utilization Ratio - Harmony Biosciences has an asset utilization ratio (sales-to-total-assets ratio) of 0.79, indicating that the company generates $0.79 in sales for every dollar in assets, which is significantly higher than the industry average of 0.24 [6]. - The company is also expected to achieve a sales growth of 17.7% this year, compared to the industry average of 17.2% [6]. Group 3: Earnings Estimate Revisions - The current-year earnings estimates for Harmony Biosciences have been revised upward, with the Zacks Consensus Estimate increasing by 3.6% over the past month [8]. - Positive trends in earnings estimate revisions are correlated with near-term stock price movements, further validating the company's growth potential [7]. Group 4: Overall Positioning - Harmony Biosciences has earned a Growth Score of A and holds a Zacks Rank 1 (Strong Buy), positioning it well for potential outperformance in the market [10].

Core Viewpoint - Harmony Biosciences Holdings, Inc. (HRMY) has seen a 13.5% increase in share price over the past four weeks, closing at $39.54, with a potential upside of 29% based on Wall Street analysts' mean price target of $51 [1][12] Price Targets - The average of 10 short-term price targets ranges from a low of $28 to a high of $75, with a standard deviation of $13.58, indicating variability in analysts' estimates [2] - The lowest estimate suggests a decline of 29.2%, while the highest indicates an upside of 89.7% [2] Analyst Sentiment - There is strong agreement among analysts regarding HRMY's ability to report better earnings than previously predicted, which supports the view of potential upside [4][9] - The Zacks Consensus Estimate for the current year has increased by 6.8% over the past month, with no negative revisions [10] Zacks Rank - HRMY holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimates [11] Conclusion on Price Targets - While the consensus price target may not be a reliable indicator of the extent of HRMY's potential gains, it does provide a directional guide for price movement [12]

Core Insights - Harmony Biosciences Holdings, Inc. (HRMY) is currently viewed as a better value opportunity compared to Repligen (RGEN) for investors interested in Medical - Biomedical and Genetics stocks [1] Valuation Metrics - HRMY has a forward P/E ratio of 12.06, significantly lower than RGEN's forward P/E of 99.13 [5] - HRMY's PEG ratio stands at 0.51, indicating a favorable valuation relative to its expected earnings growth, while RGEN's PEG ratio is much higher at 4.76 [5] - HRMY's P/B ratio is 3.71, compared to RGEN's P/B of 4.70, suggesting HRMY is more attractively priced relative to its book value [6] Zacks Rank and Style Scores - HRMY holds a Zacks Rank of 1 (Strong Buy), indicating a positive earnings outlook, while RGEN has a Zacks Rank of 3 (Hold) [3] - Based on the Style Scores system, HRMY has a Value grade of A, whereas RGEN has a Value grade of D, further supporting HRMY as the preferred choice for value investors [6]

Company Overview - Harmony Biosciences Holdings, Inc. is a Pennsylvania-based commercial stage pharmaceutical company known for marketing and selling Wakix (pitolisant) [2] Investment Insights - The company provides catalysts for investors to look out for, along with buy and sell ratings, product sales forecasts, and integrated financial statements [2] - Analysts have been covering biotech, healthcare, and pharma sectors for over 5 years, producing detailed reports on more than 1,000 companies [2] Analyst Position - The analyst has no current stock, option, or similar derivative position in any of the companies mentioned but may initiate a long position in HRMY within the next 72 hours [3]

Core Viewpoint - Harmony Biosciences Holdings, Inc. (HRMY) is experiencing solid improvement in earnings estimates, which may lead to continued short-term price momentum and an improving earnings outlook [1][2]. Estimate Revisions - The upward trend in earnings estimate revisions indicates growing analyst optimism regarding Harmony Biosciences' earnings prospects, which is expected to positively impact its stock price [2]. - For the current quarter, the earnings estimate is $0.73 per share, reflecting a +62.22% change from the previous year [4]. - The Zacks Consensus Estimate for the current quarter has increased by 5.49% over the last 30 days, with one estimate moving higher and no negative revisions [4]. - For the full year, the earnings estimate stands at $2.43 per share, representing a +14.08% change from the previous year [5]. - The consensus estimate for the current year has increased by 15.8%, with one estimate moving higher and no negative revisions [5]. Zacks Rank - The positive estimate revisions have led Harmony Biosciences to achieve a Zacks Rank 1 (Strong Buy), indicating strong potential for outperformance [6]. - Stocks with Zacks Rank 1 (Strong Buy) and 2 (Buy) have historically outperformed the S&P 500 [6]. Stock Performance - Harmony Biosciences shares have increased by 8.3% over the past four weeks, suggesting investor confidence in its earnings growth prospects [7].

Group 1 - Harmony Biosciences Holdings, Inc. (HRMY) shares have increased by 8.3% over the past four weeks, closing at $36.42, with a mean price target of $50.80 indicating a potential upside of 39.5% [1] - The mean estimate consists of 10 short-term price targets with a standard deviation of $13.43, where the lowest estimate is $28 (23.1% decline) and the highest is $75 (105.9% increase) [2] - Analysts show strong agreement in revising earnings estimates higher, with the Zacks Consensus Estimate for the current year increasing by 15.8% over the last 30 days [9][10] Group 2 - HRMY holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimates [11] - The clustering of price targets with a low standard deviation suggests a high degree of agreement among analysts regarding the stock's price movement [7] - While price targets may not be reliable indicators of actual price movements, they can provide a directional guide for potential stock performance [12]

Investors interested in stocks from the Medical - Biomedical and Genetics sector have probably already heard of Harmony Biosciences Holdings, Inc. (HRMY) and Repligen (RGEN) . But which of these two companies is the best option for those looking for undervalued stocks? Let's take a closer look.The best way to find great value stocks is to pair a strong Zacks Rank with an impressive grade in the Value category of our Style Scores system. The Zacks Rank is a proven strategy that targets companies with positiv ...

Company Participation in Industry Events - Harmony Biosciences Holdings Inc will participate in the 43rd Annual J P Morgan Healthcare Conference in San Francisco CA on January 15 2025 [1] - Jeffrey M Dayno MD President and Chief Executive Officer is scheduled to present at the conference at 11:15 am PT 2:15 pm ET [1] - A webcast of the fireside chat will be available on the investor page of Harmony's website [1] Company Overview - Harmony Biosciences is a pharmaceutical company focused on developing and commercializing innovative therapies for patients with rare neurological diseases [2] - The company is driven by novel science visionary thinking and a commitment to addressing unmet medical needs [2] - Established by Paragon Biosciences LLC in 2017 and headquartered in Plymouth Meeting PA [2] - The company aims to create a better future through therapeutic innovations culture and community programs [2] Contact Information - Investor contact Brennan Doyle can be reached at 484-539-9700 or via email [3] - Media contact Cate McCanless can be reached at 202-641-6086 or via email [3]