Core Viewpoint - Harmony Biosciences Holdings, Inc. is under investigation for potential securities fraud and unlawful business practices following a negative FDA response regarding its drug pitolisant [1][2]. Group 1: Company Overview - Harmony Biosciences Holdings, Inc. trades on NASDAQ under the ticker HRMY [1]. - The company recently received a Refusal to File (RTF) letter from the FDA concerning pitolisant, which is intended for treating excessive daytime sleepiness in adult patients with idiopathic hypersomnia [2]. Group 2: Financial Impact - Following the FDA's announcement, Harmony's stock price dropped by $3.77 per share, representing a decline of 9.64%, closing at $35.32 per share on February 19, 2025 [2]. Group 3: Legal Context - Pomerantz LLP is leading the investigation into Harmony, focusing on whether the company and its officers engaged in securities fraud or other unlawful practices [1]. - Pomerantz LLP has a long history in corporate and securities class litigation, having recovered significant damages for victims of securities fraud [3].

Financial Data and Key Metrics Changes - The company reported net product revenues of $714.7 million for 2024, representing a 23% year-over-year growth. In Q4 alone, net revenue was $201.3 million, reflecting a 20% increase from $168.4 million in the prior year quarter [11][25][55] - Non-GAAP adjusted net income for Q4 2024 was $63 million, or $1.08 per diluted share, compared to $42.8 million or $0.73 per diluted share in the prior year quarter [56] - The company ended Q4 with approximately $576 million in cash and cash equivalents, reflecting robust cash generation of approximately $219.8 million from operations in 2024 [55][57] Business Line Data and Key Metrics Changes - The average number of patients on WAKIX increased to approximately 7,100 in Q4, with a sequential increase of about 300 patients from the previous quarter [25][26] - The growth in WAKIX prescriptions was primarily driven by adult narcolepsy, which constitutes approximately 95% of the diagnosed narcolepsy opportunity [27] - The company anticipates net revenue guidance for WAKIX in 2025 to be between $820 million and $860 million [30][58] Market Data and Key Metrics Changes - The company continues to see strong double-digit growth in net revenue for WAKIX, demonstrating sustained demand in the narcolepsy market [25][26] - The company is on track to initiate pivotal Phase 3 registration trials for pitolisant HD in both narcolepsy and idiopathic hypersomnia in Q4 2025, with anticipated PDUFA dates in 2028 [40][41] Company Strategy and Development Direction - The company aims to become a leading CNS company focused on developing innovative treatments for patients with unmet medical needs, with a pipeline poised to deliver over $3 billion in net revenue [9][10] - The company is committed to defending its intellectual property and has announced its first generic settlement agreement with Novagen Pharma, reinforcing the strength of its IP portfolio [12][100] - The company is actively engaged in identifying additional opportunities to expand its leadership in Sleep/Wake, neurobehavioral disorders, and rare epilepsies [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of WAKIX, projecting it to be a $1 billion plus opportunity in narcolepsy alone [11][12] - The company views 2025 as a transformational year, with key clinical milestones expected to reinforce its leadership in Sleep/Wake and rare CNS disorders [17][23] - Management acknowledged challenges with the supplemental new drug application for pitolisant in idiopathic hypersomnia but emphasized their commitment to the patient community [15][16] Other Important Information - The company has a robust late-stage pipeline with four ongoing Phase 3 registrational trials and plans to initiate six by the end of the year [36] - The company is advancing its next-generation pitolisant formulations, including pitolisant HD and pitolisant GR, designed to address unmet needs in narcolepsy and idiopathic hypersomnia [41][42] Q&A Session Summary Question: Can you provide updates on ZYN002 and the Phase 3 study? - Management expressed satisfaction with the ongoing trial and noted that they are on track for top-line data in Q3 2025. They are enrolling patients aged three to 30 years and have seen a good rollover rate into the long-term extension study [66][71] Question: What is the rationale for Pitolisant HD's likelihood of success in IH patients? - Management highlighted the evidence of efficacy from previous studies and the optimized formulation of pitolisant HD, which is expected to deliver enhanced therapeutic benefits [76][79] Question: How confident is the company in the timeline for Pitolisant HD trials given competition? - Management indicated confidence in the recruitment process due to established relationships with clinical trial sites and the robust signal from previous studies [84][88] Question: What is the status of remaining patent challenges? - Management confirmed ongoing litigation processes and mentioned a Markman hearing scheduled for March, with a trial set for 2026 [96][99] Question: What would success look like for the ZYN002 trial? - Success would be defined by demonstrating a statistically significant and clinically meaningful outcome on the primary endpoint, with supportive data from the previous CONNECT study [104][109]

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].

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]