Financial Data and Key Metrics Changes - Harmony Biosciences reported net revenue of $239.5 million for Q3 2025, representing a 29% year-over-year growth [5][20] - The company raised its full-year net revenue guidance from $820-$860 million to $845-$865 million [5][22] - Cash generation for the quarter was robust at $106 million, bringing total cash and cash equivalents to $778 million as of September 30, 2025 [5][21] Business Line Data and Key Metrics Changes - Wakix achieved net sales of $239.5 million in Q3 2025, with an average increase of 500 patients added, resulting in approximately 8,100 average patients by the end of Q3 [9][20] - The performance of Wakix is attributed to its unique position as the only non-scheduled treatment option, leading to high brand awareness and broad payer coverage [9][10] Market Data and Key Metrics Changes - The company is rapidly approaching blockbuster status for Wakix in narcolepsy, with expectations of exceeding $1 billion in annual revenue from this indication alone [6][11] - The market for narcolepsy treatments is expected to expand with the introduction of new therapies, but Harmony remains confident in Wakix's continued growth [45][46] Company Strategy and Development Direction - Harmony aims to become a leading patient-focused CNS company, focusing on innovative treatments for unmet medical needs [7][8] - The company has a robust late-stage pipeline with multiple catalysts expected in the coming years, including the initiation of two phase 3 trials for Pitolisant HD [7][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, driven by strong fundamentals and execution across the organization [24][91] - The management team highlighted the importance of maintaining a profitable, self-funding biotech profile while pursuing strategic opportunities to enhance the product portfolio [8][22] Other Important Information - The IND for Pitolisant HD has been submitted to the FDA, with plans to initiate phase 3 trials for both narcolepsy and idiopathic hypersomnia by the end of 2025 [7][14] - The company is actively evaluating business development opportunities to expand its pipeline and product offerings [43][44] Q&A Session Summary Question: Can you elaborate on the trajectory of Wakix evolving into 2026? - Management noted that the strong performance is driven by patient adds, with a record increase of 500 patients in Q3, and they expect this momentum to continue into Q4 and 2026 [27][30] Question: What were the GI AEs seen with the GR formulation? - No new safety or tolerability issues were observed with the Pitolisant GR formulation, and all patients initiated treatment at the therapeutic dose without issues [34][35] Question: Thoughts on BizDev and M&A after the Zygel failure? - The company remains focused on strategic business development, actively evaluating innovative assets to enhance its pipeline [42][43] Question: How is new patient growth coming for Wakix? - Growth is attributed to both activating new prescribers and deeper penetration within existing writers, supported by strong marketing and promotional efforts [90]

Drug Approvals and Clinical Trials - Pitolisant was approved by the FDA for the treatment of EDS in adult patients with narcolepsy in August 2019, with commercial launch initiated in November 2019[123]. - The FDA granted Orphan Drug designation to pitolisant for the treatment of PWS in February 2024, with the Phase 3 TEMPO study initiated in Q1 2024[125]. - The Phase 2 trial for pitolisant in adult patients with DM1 showed clinically meaningful improvements in EDS and fatigue, with topline results announced in Q4 2023[125]. - The pivotal bioequivalence study for Pitolisant GR is anticipated to have topline data readout in Q4 2025, with a PDUFA date expected in Q1 2027[129]. - The company received positive pre-clinical data for BP1.15205, an orexin-2 receptor agonist, with first-in-human studies expected to begin in Q4 2025[130]. - A research collaboration agreement with CiRC Biosciences was established in June 2025 to develop candidates for refractory epilepsies and treatment-resistant narcolepsy[131]. - The FDA did not approve the sNDA for expanding the WAKIX label for pediatric patients with cataplexy in June 2024, but a Type A meeting was held to discuss a resubmission path[127]. - The company is committed to obtaining pediatric exclusivity for WAKIX, supported by recent FDA approvals and ongoing studies[128]. - The RECONNECT study for ZYN002 in Fragile X Syndrome did not meet its primary endpoint due to a higher than expected placebo response rate, leading to a review of the full data set[134]. - EPX-100 is currently in two Phase 3 registrational clinical trials, the ARGUS Study for Dravet Syndrome and the LIGHTHOUSE Study for Lennox-Gastaut Syndrome[135]. Financial Performance - Net product revenue for the three months ended September 30, 2025, was $239.5 million, a 28.7% increase compared to the same period in 2024, driven by a 26.8% increase in units shipped[156]. - For the nine months ended September 30, 2025, net product revenue reached $624.7 million, reflecting a 21.7% increase year-over-year, primarily due to an 18.0% increase in units shipped[156]. - The cost of product sales for the three months ended September 30, 2025, was $59.7 million, up from $42.8 million in the same period in 2024[155]. - Research and development expenses for the three months ended September 30, 2025, were $55.0 million, significantly higher than $25.4 million in the same period in 2024, reflecting increased clinical program efforts[155]. - Interest expense decreased by $0.7 million, or 16.7%, for the three months ended September 30, 2025, and decreased by $2.2 million, or 16.4%, for the nine months ended September 30, 2025, compared to the same periods in 2024[164]. - Interest income increased by $0.8 million, or 16.2%, for the three months ended September 30, 2025, and increased by $2.0 million, or 14.3%, for the nine months ended September 30, 2025, compared to the same periods in 2024[165]. - The company achieved a net income of $136.2 million for the nine months ended September 30, 2025, compared to $96.0 million in 2024, marking a 42% increase[183][184]. Expenses and Cost Management - The company expects sales and marketing expenses to rise in the near- and mid-term to support WAKIX's commercialization and potential new indications[147]. - General and administrative expenses are anticipated to increase due to hiring additional personnel and compliance costs associated with being a public company[150]. - Cost of product sales increased by $16.9 million, or 39.4%, for the three months ended September 30, 2025, and increased by $27.4 million, or 26.7%, for the nine months ended September 30, 2025, compared to the same periods in 2024[157]. - Research and development expenses increased by $29.6 million, or 116.5%, for the three months ended September 30, 2025, and increased by $28.5 million, or 25.6%, for the nine months ended September 30, 2025, compared to the same periods in 2024[159]. - Sales and marketing expenses increased by $2.0 million, or 7.2%, for the three months ended September 30, 2025, and increased by $7.0 million, or 8.4%, for the nine months ended September 30, 2025, compared to the same periods in 2024[162]. - General and administrative expenses increased by $1.2 million, or 4.3%, for the three months ended September 30, 2025, and increased by $13.5 million, or 16.6%, for the nine months ended September 30, 2025, compared to the same periods in 2024[163]. Cash Management and Investments - As of September 30, 2025, the company had cash, cash equivalents, and investments of $778.4 million, outstanding debt of $170.0 million, and retained earnings of $138.4 million[168]. - For the nine months ended September 30, 2025, cash provided by operating activities was $222.0 million, up from $144.3 million in the same period of 2024, representing a 54% increase[182]. - Net cash used in investing activities for the nine months ended September 30, 2025, was $22.0 million, a decrease from $60.3 million in 2024, indicating improved cash management[185][186]. - The company reported net cash used in financing activities of $6.0 million for the nine months ended September 30, 2025, compared to $8.3 million in 2024, reflecting a reduction in financing costs[187][188]. - As of September 30, 2025, the company had $685.2 million in investments, with an immediate 10% change in market interest rates not expected to materially impact the investment portfolio[194]. - The company had $170.0 million in borrowings outstanding as of September 30, 2025, with interest rates based on a margin ranging from 2.50% to 4.00% depending on the leverage ratio[195]. Acquisitions and Agreements - In October 2023, the company acquired Zynerba Pharmaceuticals, gaining global rights to develop and commercialize ZYN002, a synthetic cannabidiol gel for transdermal delivery[134]. - In April 2024, the company acquired Epygenix Therapeutics, obtaining an exclusive license for EPX-100, targeting Dravet Syndrome and Lennox-Gastaut Syndrome, with a total addressable market of approximately 5,000 and 35,000 patients respectively[135]. - The company acquired HBS-102, a MCHR1 antagonist, with encouraging results from preclinical studies reported in Q3 2024[133]. - The company entered into a License and Commercialization Agreement with Bioprojet in July 2022, obtaining exclusive rights to develop new products based on pitolisant in the U.S. and Latin America[129]. - The company entered into a sublicense agreement with Bioprojet in April 2024, paying an upfront license fee of $25.5 million and potentially up to $367.5 million upon achieving development and sales milestones[177]. - The company entered into a research collaboration with CiRC Biosciences, Inc., paying an upfront fee of $15.0 million and potential milestone payments of $2.0 million for each of the two candidates[179][180]. - A clinical milestone for ZYN002 was achieved in September 2025, triggering a $15.0 million payment to contingent value rights holders, expected to be paid in Q4 2025[181].

Q3 2025 Financial Results & Business Update November 4 , 2025 Copyright © 2024 Harmony Biosciences. All rights reserved. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our full year 2024 net product revenue, expectations for ...

Financial Performance - WAKIX franchise generated net revenue of approximately $239 million in Q3 2025, representing a 29% year-over-year revenue growth[2] - The company raised its 2025 revenue guidance to a range of $845-$865 million from the previous range of $820-$860 million[2] - Harmony Biosciences will report full Q3 2025 financial results on November 4th, 2025, before the U.S. financial markets open[2] - The preliminary results are based on management's initial review and are subject to revision, indicating potential changes in actual results[4] Product Performance and Market Potential - The average number of patients increased by approximately 500, reaching 8,100 average patients in Q3 2025, indicating a strong trajectory towards potential blockbuster status for WAKIX in narcolepsy[2] - WAKIX is approved for treating excessive daytime sleepiness and cataplexy in adult and pediatric patients with narcolepsy, showcasing its therapeutic potential[5] - The company is exploring the therapeutic potential of pitolisant in additional indications, which may enhance its market position[24] Strategic Focus and Development - Harmony is committed to developing innovative therapies for patients with rare neurological diseases, reflecting its strategic focus[21] - The company emphasizes the importance of favorable insurance coverage and reimbursement for WAKIX to support its commercialization efforts[24] - Harmony's growth strategy includes identifying and integrating additional products or candidates with significant commercial potential[24]

Core Insights - Harmony Biosciences Holdings, Inc. reported earnings of $239.5 million for Q3 2025, marking a 29% year-over-year revenue growth for WAKIX® [1] - The revenue growth was driven by an increase of approximately 500 in the average number of patients for the quarter, indicating a strong trajectory towards blockbuster status for WAKIX in the treatment of narcolepsy [1] - The company has achieved four consecutive years of revenue growth and profitability, showcasing its strong market position and operational success [1]

Core Insights - Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) is recognized as a promising growth stock by analysts, with a Buy rating reiterated by Truist Financial on October 24 [1] - The company reported strong Q3 2025 performance for its WAKIX product, generating approximately $239 million in revenue, marking a 29% year-over-year growth [2] - The increase in revenue was attributed to a record rise in the average number of patients, which grew by 500 to reach 8,100 during the quarter [2] - Harmony has also raised its revenue guidance for 2025 to a range of $845 million to $865 million, up from the previous range of $820 million to $860 million [3] - The company focuses on developing and commercializing therapies for rare neurological diseases and other unmet medical needs [3]

Core Insights - Harmony Biosciences Holdings, Inc. (HRMY) shares increased by 12.7% to close at $29.6, supported by strong trading volume, contrasting with a 1.8% loss over the past four weeks [1][2] Financial Performance - The company reported preliminary third-quarter 2025 revenues for the Wakix (pitolisant) franchise at approximately $239 million, marking a 29% year-over-year increase [2] - Harmony Biosciences raised its revenue guidance for 2025 to a range of $845-$865 million, up from the previous estimate of $820-$860 million [2] - The expected quarterly earnings per share (EPS) for the upcoming report is $0.83, reflecting a year-over-year change of +5.1%, with revenues anticipated at $220.95 million, an 18.8% increase from the previous year [3] Market Sentiment - The consensus EPS estimate for Harmony Biosciences has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] - The stock currently holds a Zacks Rank of 3 (Hold), indicating a neutral outlook [5] Industry Context - Harmony Biosciences operates within the Zacks Medical - Biomedical and Genetics industry, alongside Oculis Holding AG (OCS), which saw a 0.7% increase in its stock price recently and has returned 19.6% over the past month [5]

Core Insights - Harmony Biosciences announced strong preliminary results for Q3 2025, driven by the performance of WAKIX, which shows significant market potential [1][6] - The company raised its 2025 revenue guidance to a range of $845 million to $865 million, up from the previous range of $820 million to $860 million [6] Financial Performance - WAKIX generated approximately $239 million in net revenue for Q3 2025, reflecting a 29% year-over-year growth [6] - The average number of patients using WAKIX increased by approximately 500, reaching 8,100 patients in Q3 2025, indicating a strong trajectory towards potential blockbuster status [6] Upcoming Events - Harmony will report full Q3 2025 financial results on November 4, 2025, and will host a conference call at 8:30 a.m. ET on the same day [2][3]

Core Insights - The health care sector is experiencing a trend of oversold stocks, presenting potential buying opportunities for undervalued companies [1][2] Group 1: Oversold Stocks - MoonLake Immunotherapeutics (NASDAQ: MLTX) has an RSI of 21.5, with a stock price drop of approximately 86% over the past month, reaching a 52-week low of $5.95. The stock saw a 13% increase to close at $8.43 [3][7] - CorVel Corp (NASDAQ: CRVL) has an RSI of 27.2, with a stock price decline of around 14% over the past month, hitting a 52-week low of $72.15. The stock rose 0.6% to close at $73.83 [4][7] - Harmony Biosciences Holdings Inc (NASDAQ: HRMY) has an RSI of 28.9, with a stock price decrease of about 24% over the past month, reaching a 52-week low of $26.26. The stock gained 2% to close at $27.28 [4][7] Group 2: Company Updates - MoonLake Immunotherapeutics reported week-16 results from its Phase 3 VELA-1 and VELA-2 trials, using HiSCR75 as the primary endpoint [7] - CorVel's CFO Brandon T. O'Brien stepped down, impacting the company's stock performance [7] - Harmony Biosciences Holdings announced topline results from its Phase 3 RECONNECT Study for ZYN002 in Fragile X syndrome, highlighting a catalyst-rich pipeline and plans for future trials [7]

Core Insights - The health care sector is experiencing a trend of oversold stocks, presenting potential buying opportunities for undervalued companies [1][2] Group 1: Oversold Stocks - MoonLake Immunotherapeutics (NASDAQ: MLTX) has an RSI of 21.5, with a stock price drop of approximately 86% over the past month, reaching a 52-week low of $5.95. Recent price action saw a 13% increase, closing at $8.43 [3][7] - CorVel Corp (NASDAQ: CRVL) has an RSI of 27.2, with a stock price decline of around 14% over the past month, hitting a 52-week low of $72.15. The stock rose 0.6% to close at $73.83 [4][7] - Harmony Biosciences Holdings Inc (NASDAQ: HRMY) has an RSI of 28.9, with a stock price decrease of about 24% over the past month, reaching a 52-week low of $26.26. The stock gained 2% to close at $27.28 [4][7] Group 2: Company Developments - MoonLake Immunotherapeutics reported week-16 results from its Phase 3 VELA-1 and VELA-2 trials, using HiSCR75 as the primary endpoint [7] - CorVel's CFO Brandon T. O'Brien stepped down, impacting the company's stock performance [7] - Harmony Biosciences released topline results from its Phase 3 RECONNECT Study for ZYN002 in Fragile X syndrome, highlighting a catalyst-rich pipeline and plans for future trials [7]