Small biotech companies can sometimes offer great benefits, with one or more potentially disruptive drugs in their pipeline. However, most of the times I am not interested because this is more than offset by a multitude"Fundamental Options" would be the title of my investing style, because I combine fundamental analysis with the power of options. I use Fundamental Analysis to quantitatively and qualitatively assess individual stocks and ETFs, and I pursue various strategies: Income oriented, especially BDCs ...

Shares of Harmony Biosciences (HRMY) have lost 10.8% in the past six months compared with the industry’s decline of 9.7%. The stock has also underperformed the S&P 500 index during this timeframe.The stock was hit last month after the company announced that it received a Refusal to File (RTF) letter from the FDA for pitolisant for the treatment of excessive daytime sleepiness (EDS) in adult patients with idiopathic hypersomnia (IH).Image Source: Zacks Investment ResearchNonetheless, the fourth-quarter resul ...

NEW YORK, March 3, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of  Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (NASDAQ: HRMY). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.The investigation concerns whether Harmony and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On Feb ...

Q4 & FY 2024 Financial Results & Business Update February 25, 2025 Copyright © 2025 Harmony Biosciences. All rights reserved. Forward-Looking Statements This presentation includes forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Harmony Biosciences Holdings, Inc.'s (the "Company") future financial position, preliminary financ ...

Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q4 2024 Earnings Conference Call February 25, 2025 8:30 AM ET Company Participants Jeffrey Dayno - President, Chief Executive Officer Jeffrey Dierks - Chief Commercial Officer Kumar Budur - Chief Medical Officer, Scientific Officer Sandip Kapadia - Chief Financial Officer, Chief Administrative Officer Brennan Doyle - Head of Investor Relations Conference Call Participants Charles Duncan - Cantor Fitzgerald John Gregory Dean - Oppenheimer David Amsellem - Pipe ...

Harmony Biosciences Holdings, Inc. (HRMY) came out with quarterly earnings of $0.85 per share, beating the Zacks Consensus Estimate of $0.74 per share. This compares to earnings of $0.45 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 14.86%. A quarter ago, it was expected that this company would post earnings of $0.64 per share when it actually produced earnings of $0.79, delivering a surprise of 23.44%.Over the last four qua ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39450 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 82-22 ...

Financial Performance - Preliminary net revenue for WAKIX® in Q4 2024 was approximately $201 million, compared to $168.4 million in Q4 2023, representing a growth of ~19.5%[7] - Full year 2024 net revenue for WAKIX® reached approximately $714 million, up from $582 million in 2023, indicating a growth of ~23%[7] - 2025 net revenue guidance for WAKIX® is projected between $820 million and $860 million, positioning the company for a potential $1 billion+ opportunity[1] - The company is entering 2025 with strong momentum and a clear path toward long-term growth, aiming for over $3 billion in net revenue going forward[4] Patient and Market Growth - The average number of patients on WAKIX® increased by approximately 300 sequentially to about 7,100 in Q4 2024[7] - Harmony Biosciences emphasizes the importance of commercialization efforts and market acceptance for its products, particularly WAKIX[34] Pipeline and Development - Key catalysts anticipated in 2025 include FDA decision on pitolisant sNDA for Idiopathic Hypersomnia in Q1 and pivotal Phase 3 data for ZYN002 in Fragile X Syndrome in Q3[1][7] - The pipeline includes up to six Phase 3 clinical programs expected by year-end 2025, with the potential to generate over $3 billion in net revenue[13] - The company initiated a pivotal Phase 3 study in Lennox-Gastaut syndrome (LGS) for EPX-100 in Q4 2024, with further studies planned for 2025[13] - The company anticipates at least one new product or indication approval every year for the next four years, extending to 2028[13] - The FDA decision on the pitolisant sNDA for Idiopathic Hypersomnia is expected in 2025, with potential approval following[7] - EPX-100, a clemizole hydrochloride, is under development for Dravet syndrome and Lennox-Gastaut syndrome, targeting central 5-hydroxytryptamine receptors[30] Disease Information - Dravet syndrome has an estimated incidence rate of 1:15,700, with approximately 85% of cases caused by de novo loss-of-function mutations in the SCN1A gene[31] - Lennox-Gastaut syndrome affects approximately 48,000 patients in the U.S., characterized by multiple seizure types and developmental issues[32] Company Strategy and Risks - Harmony Biosciences focuses on developing therapies for rare neurological diseases, established in 2017 and headquartered in Plymouth Meeting, PA[33] - The company plans to submit a supplemental New Drug Application (sNDA) for pitolisant in idiopathic hypersomnia, aiming for growth in net product revenue for 2024[34] - The company is exploring the therapeutic potential of pitolisant in additional indications and has ongoing clinical trials[34] - Harmony aims to expand its license agreements and acquire products with significant commercial potential[34] - The company acknowledges risks related to competition, regulatory approvals, and market fluctuations that may impact future performance[34] - Harmony's management is committed to maintaining effective internal controls and addressing the challenges of operating as a public company[34]

Core Viewpoint - Harmony Biosciences Holdings, Inc. (HRMY) has received an upgrade to a Zacks Rank 1 (Strong Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Stock Price Impact - The Zacks rating system is primarily based on a company's changing earnings picture, with the Zacks Consensus Estimate tracking EPS estimates from sell-side analysts [2]. - Changes in earnings estimates are strongly correlated with near-term stock price movements, influenced by institutional investors who adjust their valuations based on these estimates [5]. - Rising earnings estimates and the subsequent rating upgrade for Harmony Biosciences indicate an improvement in the company's underlying business, suggesting potential upward pressure on the stock price [6]. Zacks Rank System - The Zacks Rank stock-rating system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [8]. - The system maintains a balanced distribution of 'buy' and 'sell' ratings across over 4000 stocks, ensuring that only the top 5% receive a 'Strong Buy' rating [10]. Recent Earnings Estimate Revisions - For the fiscal year ending December 2024, Harmony Biosciences is expected to earn $2.41 per share, reflecting a 13.2% increase from the previous year [9]. - Over the past three months, the Zacks Consensus Estimate for Harmony Biosciences has increased by 21.1%, indicating positive sentiment among analysts [9]. Conclusion - The upgrade to Zacks Rank 1 positions Harmony Biosciences in the top 5% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [11].

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].