Financial Data and Key Metrics Changes - The company reported net revenue of $239.5 million for Q3 2025, representing a 29% year-over-year growth [5][20] - Cash generation was robust at $106 million, bringing the total cash and cash equivalents to $778 million as of September 30, 2025 [5][22] - Non-GAAP adjusted net income for Q3 2025 was $63.5 million, or $1.8 per diluted share, compared to $57.3 million, or $0.99 per diluted share in the prior year quarter [21][22] Business Line Data and Key Metrics Changes - The WCAGX product line achieved an average of 8,100 patients by the end of Q3, with a record increase of approximately 500 new patients added during the quarter [9][10] - The company raised its full-year revenue guidance from $820 million to a range of $845 million to $865 million, reflecting strong demand for WCAGX [12][23] Market Data and Key Metrics Changes - The company noted that WCAGX is rapidly approaching blockbuster status, with expectations of exceeding $1 billion in annual revenue from narcolepsy alone [6][25] - The company has secured important new payer coverage wins, which continue to expand its already broad payer coverage [11] Company Strategy and Development Direction - The company aims to become a leading patient-focused CNS company, delivering innovative treatments for unmet medical needs [7] - The late-stage pipeline includes multiple catalysts, with plans to initiate two Phase III trials for Pitolacin HD by the end of 2025 [6][14] - The company is focused on strategic business development to enhance its pipeline and product portfolio [46][67] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth trajectory, driven by strong fundamentals and execution across the organization [12][113] - The company anticipates ongoing investments in R&D to advance its late-stage pipeline, with five Phase III registrational programs expected by year-end [23][24] Other Important Information - The company has filed utility patents for both Pitolacin GR and HD, securing potential exclusivity until 2044 [16][76] - The IND for Pitolacin HD has been submitted to the FDA, with target PDUFA dates set for 2028 [14][16] Q&A Session Summary Question: Can you elaborate on the trajectory of WCAGX evolving into 2026? - Management noted that the performance is driven fundamentally by patient adds, with a record increase of 500 patients in Q3, and strong fundamentals are expected to carry forward into Q4 and 2026 [30][33] Question: What were the GI AEs seen with the GR formulation? - No new safety or tolerability issues were observed with the Pitolacin GR formulation, and all patients were able to initiate treatment at the therapeutic dose without issues [35][36] Question: What are the current thoughts on business development and M&A? - The company remains focused on strategic business development, actively evaluating several opportunities to enhance its pipeline [46][67] Question: How is new patient growth coming from? - New patient growth is primarily from deeper penetration within existing prescribers, with a stable breakdown of NT1 and NT2 patients [120][97] Question: Can you discuss the EPX-100 epilepsy program? - The company is excited to share efficacy data at the upcoming American Epilepsy Society meeting and continues to recruit patients for ongoing studies [87][88]

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].

Financial Performance - Q3 2025 net product revenue reached $239.5 million, a 29% increase year-over-year compared to $186.0 million in Q3 2024[6, 36] - The company raised its full-year 2025 revenue guidance to $845 million - $865 million[6] - Non-GAAP adjusted net income increased by 11% from $57.3 million in Q3 2024 to $63.5 million in Q3 2025[36] - Cash, cash equivalents, and investments increased to $778.4 million in Q3 2025, a 54% increase compared to $504.7 million in Q3 2024[36, 38] WAKIX Performance - WAKIX average patients reached 8,100[11] - Approximately 500 average patient additions, representing the highest quarterly increase since launch[11] - Strong payer coverage of WAKIX at >80% of lives[11] Pipeline Development - The company plans to initiate Phase 3 registrational trials for Pitolisant HD in narcolepsy and IH in Q4 2025[20, 21] - Topline data from the pivotal bioequivalence study of Pitolisant GR is expected in Q4 2025[25, 33] - Phase 3 registrational trials are ongoing for EPX-100 in Dravet Syndrome (ARGUS study) and Lennox-Gastaut Syndrome (LIGHTHOUSE study), with topline data anticipated in 2026[19, 31, 33] - The Phase 3 RECONNECT study for ZYN002 in Fragile X Syndrome (FXS) did not meet the primary endpoint due to a higher-than-expected placebo response rate, and a review of the full data set is ongoing[19, 28]

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]