Sodium Oxybate

– Record total revenues of $4.3 billion in 2025 (+5% YoY) and $1.2 billion (+10% YoY) in 4Q25 – – Expect to complete sBLA submission in 1Q26 under RTOR for zanidatamab in HER2+ 1L GEA – – Xywav® achieved $1.7 billion in revenue and 12% YoY growth in 2025 – – Epidiolex® achieved $1.1 billion in revenue and 9% YoY growth in 2025 – – Strong Modeyso™ launch with $37 million in revenue in first full quarter on market – – Expect 2026 total revenues of $4.25 to $4.50 billion – DUBLIN, Feb. 24, 2026 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the full year and fourth quarter of 2025 and provided financial guidance for 2026. "2025 was an exceptional year for Jazz, representing our 21st consecutive year of top-line growth and underscoring our commitment to operational excellence as we deliver meaningful innovation for patients," said Renee Gala, president and chief executive officer of Jazz Pharmaceuticals. "In the fourth quarter, our disciplined execution resulted in $1.2 billion in revenue, reflecting 10% year-over-year growth and our highest revenue quarter ever. This performance provides us with strong momentum into 2026, as we prepare for the potential launch of zanidatamab in GEA, sustain launch execution for Modeyso and Zepzelca®, and reinforce the differentiated profiles of Epidiolex and Xywav as the leading branded treatments for epilepsy and narcolepsy, respectively. In parallel, we continue to advance our pipeline and pursue a corporate development strategy aligned with our rare disease focus that supports durable growth and long-term value creation for patients and shareholders." "Jazz had a transformative year across our R&D pipeline, led by the HERIZON-GEA-01 data, which we believe firmly positions zanidatamab as the HER2-targeted agent of choice, with the potential to reshape first-line treatment for HER2+ metastatic GEA patients," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. "We expect to build on this progress in 2026, as these results not only highlight zanidatamab's potential to help patients with GEA, but also de-risk our clinical trials in additional indications, including HER2+ metastatic breast cancer." Key 2025 Highlights Total revenues in 2025 grew to $4.3 billion (+5% year-over-year (YoY)), generating $1.4 billion in cash from operations. Research & Development: Practice-changing Phase 3 HERIZON-GEA-01 results support zanidatamab as the HER2-targeted agent of choice in HER2+ 1L gastroesophageal adenocarcinoma (GEA), regardless of PD-L1 status. Multiple registrational trials of zanidatamab are underway, including in metastatic breast cancer (mBC), supporting a broad development program designed to maximize patient impact and long-term shareholder value. Commercial: Continued leadership in rare sleep with Xywav net product sales increasing to $1.7 billion (+12% YoY) and total sleep franchise1 revenues exceeding $2 billion in 2025. Epidiolex/Epidyolex® generated more than $1 billion in 2025 net product sales (+9% YoY). Completed acquisition of Chimerix Inc., secured FDA approval for and successfully launched Modeyso (dordaviprone) in H3 K27M-mutant diffuse midline glioma, achieving $48 million in sales since launch in August 2025. Received FDA approval and launched Zepzelca, in combination with atezolizumab, for first-line maintenance treatment of extensive-stage small cell lung cancer. Company expects 2026 total revenue of between $4.25 and $4.50 billion, with double-digit growth across the combined epilepsy and oncology franchises, and Xywav revenue flat to up mid-single digits. Tom Riga was named chief business officer to accelerate corporate development efforts across rare disease. Business Updates Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution: Xywav net product sales increased 12% to $1.7 billion in 2025 and increased 16% to $465 million in 4Q25 compared to the same periods in 2024. Strong new patient growth continued, with approximately 500 net patient adds in 4Q25. There were approximately 16,175 active patients exiting the quarter, comprised of approximately 10,950 narcolepsy patients and approximately 5,225 idiopathic hypersomnia (IH) patients. Epidiolex/ Epidyolex (cannabidiol): Epidiolex/Epidyolex achieved blockbuster status in 2025 with net product sales increasing 9% to $1.1 billion in 2025 and increasing 4% to $287 million in 4Q25 compared to the same periods in 2024. Ziihera® (zanidatamab-hrii): Ziihera net product sales in biliary tract cancer (BTC) were $25 million in 2025 and $9 million in 4Q25 following product launch in December 2024. Expect to complete supplemental biologics license application (sBLA) submission under Real Time Oncology Review (RTOR) in 1Q26 with potential launch in 1L HER2+ GEA in 2H26. FDA granted Breakthrough Therapy designation (BTD) for zanidatamab's development for patients with HER2+ unresectable locally advanced or metastatic GEA. Submitted HERIZON-GEA-01 data for potential inclusion in National Comprehensive Cancer Network (NCCN) guidelines. EmpowHER-BC-303 trial in mBC patients previously treated with, or intolerant to, trastuzumab deruxtecan on track to complete enrollment in 1H27, with top-line results expected in late 2027 or early 2028. Modeyso (dordaviprone): Following product launch in August 2025, Modeyso net product sales were $48 million in 2025 and $37 million in 4Q25. The Company sold its Rare Pediatric Disease Priority Review Voucher for gross proceeds of $200 million (50% to Jazz). Zepzelca (lurbinectedin): Zepzelca net product sales decreased 4% to $307 million in 2025 and increased 15% to $90 million in 4Q25 compared to the same periods in 2024. Financial Highlights Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release. Total Revenues Total revenues increased 5% in 2025 and 10% in 4Q25 compared to the same periods in 2024. Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, was $3.1 billion in 2025, an increase of 6% compared to $2.9 billion in 2024, and $848 million in 4Q25, an increase of 8% compared to $786 million in 4Q24. The increase in both periods was primarily due to higher Xywav and Epidiolex/Epidyolex net product sales, partially offset by decreased Xyrem net product sales. Oncology net product sales were $1.1 billion in 2025, an increase of 2% compared to 2024, and $337 million in 4Q25, an increase of 16% compared to $292 million in 4Q24, primarily due to the inclusion of Modeyso and Ziihera net product sales in both periods. The increase in 4Q25 also included higher Zepzelca net product sales, partially offset by decreased Vyxeos® net product sales. Operating Expenses and Income Tax (Benefit) Expense Changes in operating expenses and income tax (benefit) expense in 2025 and 4Q25 over the prior year periods are primarily due to the following: Cost of product sales, on a GAAP and non-GAAP adjusted basis, increased in 2025 compared to 2024, primarily due to changes in product mix. Cost of product sales, on a GAAP basis, in 2025 included higher acquisition accounting inventory fair value step up expense compared to 2024. Cost of product sales, on a GAAP and non-GAAP adjusted basis, increased in 4Q25 compared to 4Q24, primarily due to changes in product mix, partially offset by lower inventory provisions. Selling, general and administrative (SG&A) expenses, on a GAAP and non-GAAP adjusted basis, increased in 2025 compared to 2024, primarily due to Xyrem antitrust litigation settlements of $234 million, the Avadel litigation settlement of $90 million and higher compensation-related expenses. SG&A expenses, on a GAAP and non-GAAP adjusted basis, increased in 4Q25 compared to 4Q24, primarily due to higher compensation-related expenses. Research and development (R&D) expenses, on a GAAP and non-GAAP adjusted basis, decreased in 2025 and 4Q25, compared to the same periods in 2024, primarily due to lower clinical study costs primarily related to zanidatamab as a result of timing of clinical trial activities, JZP385 (essential tremor) following discontinuation of this program, and JZP258 (XYLO/DUET) due to the completion of these trials in the first half of 2025, partially offset by the addition of costs relating to Modeyso and increased personnel costs following the acquisition of Chimerix. Acquired in-process research and development (IPR&D) in 2025, on a GAAP and non-GAAP adjusted basis, represents the value allocated to Modeyso in the Chimerix Acquisition of $905 million and the upfront payment made in connection with our global license agreement with Saniona of $43 million. Income tax benefit in 2025, on a GAAP and non-GAAP adjusted basis, included a benefit of $213 million on recognition of certain U.S. federal and state deferred tax assets acquired through the Chimerix acquisition. Income tax benefit, on a GAAP and non-GAAP adjusted basis, in 4Q24 was primarily due to patent box benefits recognized. Cash Flow and Balance Sheet As of December 31, 2025, cash, cash equivalents and investments were $2.4 billion, and the outstanding principal balance of the Company's long-term debt was $5.4 billion. In addition, the Company had undrawn borrowing capacity under a revolving credit facility of $885 million. For the year ended December 31, 2025, the Company generated $1.4 billion of cash from operations reflecting strong business performance and continued financial discipline. 2026 Financial Guidance Jazz Pharmaceutical's full year 2026 financial guidance is as follows: Conference Call Details Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. ET (9:30 p.m. GMT) to provide a business and financial update and discuss its 2025 full year and 4Q25 results and 2026 guidance. Interested parties may register for the call here or via the Investors section of the Jazz Pharmaceuticals website at . To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. A replay of the webcast will be available via the Investors section of the Jazz Pharmaceuticals website at . About Jazz Pharmaceuticals Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with rare disease — often with limited or no therapeutic options. We have a diverse portfolio of medicines, including leading therapies addressing epilepsies, cancers and sleep disorders. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Non-GAAP Financial Measures To supplement Jazz Pharmaceuticals' financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP (also referred to as adjusted or non-GAAP adjusted) financial measures in this press release and the accompanying tables. In particular, the Company presents non-GAAP adjusted net income (and the related per share measure) and its line-item components, as well as certain non-GAAP adjusted financial measures derived therefrom, including non-GAAP adjusted gross margin percentage and non-GAAP adjusted effective tax rate. Non-GAAP adjusted net income (and the related per share measure) and its line-item components exclude from GAAP reported net income (loss) (and the related per share measure) and its line-item components certain items, as detailed in the reconciliation tables that follow, and in the case of non-GAAP adjusted net income (and the related per share measure), adjust for the income tax effect of the non-GAAP adjustments. In this regard, the components of non-GAAP adjusted net income, including non-GAAP adjusted cost of product sales, SG&A expenses and R&D expenses, are income statement line items prepared on the same basis as, and therefore components of, the overall non-GAAP adjusted net income measure. The Company believes that each of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors and analysts and that each of these non-GAAP financial measures, when considered together with the Company's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare the Company's results from period to period, to its forward-looking guidance, and to identify operating trends in the Company's business. In addition, these non-GAAP financial measures are regularly used by investors and analysts to model and track the Company's financial performance. Jazz Pharmaceuticals' management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate the Company's business and to make operating decisions, and compensation of executives is based in part on certain of these non-GAAP financial measures. Because these non-GAAP financial measures are important internal measurements for Jazz Pharmaceuticals' management, the Company also believes that these non-GAAP financial measures are useful to investors and analysts since these measures allow for greater transparency with respect to key financial metrics the Company uses in assessing its own operating performance and making operating decisions. These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles in the reconciliation tables that follow. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its non-GAAP financial measures; and the Company has ceased, and may in the future cease, to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. In this regard, commencing with the first quarter of 2025, the Company is no longer including an adjustment for non-cash interest expense in the Company's non-GAAP adjusted financial measures. For purposes of comparability, non-GAAP adjusted financial measures for the 2024 periods have been updated to reflect this change. Likewise, the Company may determine to modify the nature of its adjustments to arrive at its non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by Jazz Pharmaceuticals in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. Cautionary Note Concerning Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to: the Company's growth prospects and future financial and operating results, including the Company's 2026 financial guidance and the Company's expectations related thereto, including with respect to anticipated catalysts; anticipated multiple near-term pipeline catalysts that each represent significant opportunities to drive greater revenue and create long-term value; the Company's advancement of pipeline programs and the timing of development activities, regulatory activities, approvals, and submissions related thereto, including the timing of the completion of the submission of the sBLA for, and launch and approval of, zanidatamab in 1L GEA; planned or anticipated clinical trial events, including with respect to initiations, enrollment and data read-outs, and the anticipated timing thereof; and the Company's development, regulatory and commercialization strategy; the Company's expectations with respect to its products and product candidates and the potential of the Company's products and product candidates and the potential regulatory path related thereto; including zanidatamab's potential to be the HER2-targeted agent of choice in HER2+ 1L GEA, regardless of PD-L1 status, and to reshape first-line treatment for HER2+ metastatic GEA patients; the Company's capital allocation and corporate development strategy; the potential successful future development, manufacturing, regulatory and commercialization activities; the Company's ability to realize the commercial potential of its products; the Company's net product sales and goals for net product sales from new and acquired products; the Company's views and expectations relating to its patent portfolio, including with respect to expected patent protection, as well as expectations with respect to exclusivity; the Company's clinical trials confirming clinical benefit or enabling regulatory submissions, including the potential of the ongoing Phase 3 ACTION trial to confirm clinical benefit of Modeyso in recurrent H3 K27M-mutant diffuse glioma and extend to use in first-line patients; and other statements that are not historical facts. These forward-looking statements are based on the Company's current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward- looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: maintaining or increasing sales of, and revenue from, Xywav, Epidiolex/Epidyolex, Ziihera, Modeyso, Zepzelca and other lead marketed products; effectively launching and commercializing the Company's other products and product candidates; the successful completion of development and regulatory activities with respect to the Company's product candidates; obtaining and maintaining adequate coverage and reimbursement for the Company's products; the time-consuming and uncertain regulatory approval process, including the risk that the Company's current and/or planned regulatory submissions may not be submitted, accepted or approved by applicable regulatory authorities in a timely manner or at all, including the risk that the Company's sBLA submission for zanidatamab in 1L GEA may not be completed or, if completed, approved in a timely manner or at all; the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating or completing clinical trials and assessing patients; global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to the Company's business operations and financial results; protecting and enhancing the Company's intellectual property rights and the Company's commercial success being dependent upon the Company obtaining, maintaining and defending intellectual property protection and exclusivity for its products and product candidates; delays or problems in the supply or manufacture of the Company's products and product candidates; complying with applicable U.S. and non-U.S. regulatory requirements, including those governing the research, development, manufacturing and distribution of controlled substances; government investigations, legal proceedings and other actions; identifying and consummating corporate development transactions, financing these transactions and successfully integrating acquired products, product candidates and businesses; the Company's ability to realize the anticipated benefits of its collaborations and license agreements with third parties; the sufficiency of the Company's cash flows and capital resources; the Company's ability to achieve targeted or expected future financial performance and results and the uncertainty of future tax, accounting and other provisions and estimates; the Company's ability to meet its projected long-term goals and objectives, in the time periods that the Company anticipates, or at all, and the inherent uncertainty and significant judgments and assumptions underlying the Company's long-term goals and objectives; fluctuations in the market price and trading volume of the Company's ordinary shares; and other risks and uncertainties affecting the Company, including those described from time to time under the caption "Risk Factors" and elsewhere in the Company's Securities and Exchange Commission filings and reports, including the Company's Annual Report on Form 10-K for the year ended December 31, 2025, and future filings and reports by the Company. Other risks and uncertainties of which the Company is not currently aware may also affect the Company's forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. Contacts: Investors: [email protected] Ireland +353 1 634 3211 U.S. +1 650 496 2717 Media: [email protected] Ireland +353 1 637 2141 U.S. +1 215 867 4948 Logo - 21% more press release views with Request a Demo

WAKIX 2025 Net Revenue of $868.5 Million ; 2026 WAKIX Net Revenue Guidance of $1.0 – $1.04 Billion on Track for Blockbuster Status in Narcolepsy Recently Completed Settlements with 3 Additional Generic Filers Toward Goal of Securing WAKIX Franchise Pitolisant GR NDA Submission on Track for Q2 2026; Extends the Pitolisant Franchise into the 2040s Exploring New Opportunities to Broaden the Pitolisant Franchise Beyond Orphan/Rare into Larger CNS Indications Potential Best-In-Class Orexin-2 Agonist (BP1.15205) Phase 1 Trial Ongoing; Clinical Data Expected in Mid-2026 Conference Call and Webcast Today at 8:30 a.m. ET PLYMOUTH MEETING, Pa. --(BUSINESS WIRE)--Feb. 24, 2026-- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced earnings with reported revenue of $243.8 million for Q4 2025, representing 21% year-over-year revenue growth for WAKIX®. For the full year 2025, the company generated $868.5 million in net product revenue, reflecting continued commercial strength as evidenced by six consecutive years of revenue growth and profitability. The company enters the year with significant momentum, reinforcing its profile as a profitable, self-funding biotech company with a robust, late-stage pipeline and strong long-term growth potential. “WAKIX is on track to exceed $1 billion in revenue and achieve blockbuster status in 2026, reflecting the strength and durability of the pitolisant franchise. Based on this commercial success and our strong momentum, we see even greater opportunity for pitolisant going forward,” said Jeffrey M. Dayno , M.D., President and Chief Executive Officer of Harmony Biosciences . “The next-generation formulations of pitolisant are designed to grow our leadership in sleep-wake, extend the lifecycle of pitolisant into the 2040’s, expand into additional orphan/rare indications, and now broaden our reach beyond orphan/rare into larger CNS patient populations. Our robust late-stage pipeline, including five ongoing Phase 3 registrational trials across five distinct CNS indications, positions Harmony for multiple near-term catalysts and meaningful long-term value creation.” Fourth Quarter and Full Year 2025 Net Product Revenue for WAKIX Net product revenue for the quarter ended December 31, 2025 , was $243.8 million , compared to $201.3 million for the same period in 2024 Average number of patients on WAKIX increased by ~400 patients to ~8,500 patients in Q4 2025; representing the third consecutive quarter of ~400+ patient adds Net product revenue for the full year ended December 31, 2025 , was $868.5 million , compared to $714.7 million for the full year ended December 31, 2024 , representing ~22% growth year on year Pitolisant Franchise Strategy WAKIX: On track to achieve blockbuster status in narcolepsy Net revenue projected between $1.0 billion to $1.04 billion for the full year ending December 31, 2026 Received FDA approval of pediatric cataplexy indication on February 13 th Commercial team triggered full promotional efforts immediately upon approval Pitolisant in Prader-Willi syndrome (PWS) Phase 3 topline data readout in 2H 2026 Supports Pediatric Exclusivity for WAKIX: Fulfills the last regulatory requirement for six months of additional regulatory exclusivity on top of the longest patent for WAKIX Commercial team triggered full promotional efforts immediately upon approval Phase 3 topline data readout in 2H 2026 Supports Pediatric Exclusivity for WAKIX: Fulfills the last regulatory requirement for six months of additional regulatory exclusivity on top of the longest patent for WAKIX ANDA Litigation Update Recently completed settlements with 3 additional generic filers bringing the total to six of the seven ANDA filers The settling parties will receive licenses to launch their generic products no earlier than March 2030 if Harmony is granted pediatric exclusivity, which it is on track to obtain Pitolisant GR (gastro-resistant): On track to extend pitolisant franchise into the 2040s NDA submission in Q2 2026; anticipated PDUFA date in Q1 2027 Approximately 80-90% of patients with narcolepsy experience GI symptoms; pitolisant GR is designed to minimize the worsening of these symptoms Ability to initiate treatment at therapeutic dose with no titration Utility patents filed to extend franchise into the 2040s Approximately 80-90% of patients with narcolepsy experience GI symptoms; pitolisant GR is designed to minimize the worsening of these symptoms Ability to initiate treatment at therapeutic dose with no titration Pitolisant HD (high dose): Opportunity to expand pitolisant franchise with differentiated rare indications Phase 3 registrational clinical trials ongoing in narcolepsy (ONSTRIDE 1) and idiopathic hypersomnia (ONSTRIDE 2) Topline data in 2027; anticipated PDUFA date in 2028 Enhanced formulation with optimized PK profile, GR coating and higher dose to drive greater efficacy Differentiated indications: fatigue in narcolepsy and sleep inertia in IH Utility patents filed to expand franchise into the 2040s Topline data in 2027; anticipated PDUFA date in 2028 Enhanced formulation with optimized PK profile, GR coating and higher dose to drive greater efficacy Differentiated indications: fatigue in narcolepsy and sleep inertia in IH Exploring new pitolisant formulation to pursue broader indications in CNS patient populations in which fatigue is a prominent symptom Mechanism-based approach supported by clinical data for pitolisant in fatigue Currently planning MS fatigue as the lead indication; follow on indications under consideration include fatigue in Parkinson's disease and post-stroke fatigue Current efforts focused on formulation optimization and new modes of delivery towards a phase 1 PK study Licensed IP with patent protection until 2042 Robust Pipeline Orexin-2 receptor agonist (BP1.15205) Phase 1 clinical study ongoing; anticipates clinical PK data in mid-2026 Potential best-in-class orexin-2 receptor agonist based on a novel chemical scaffold, preclinical potency, selectivity, safety and efficacy data, and potential for once-a-day dosing EPX-100 (clemizole hydrochloride) One of the most advanced development programs in the 5HT2 (serotonin) agonist class Enrollment ongoing for Phase 3 registrational trial in Dravet syndrome (ARGUS Study) with topline data anticipated in 1H 2027 Safety and effectiveness data from the open-label extension study in DS was presented at AES meeting in December 2025 Enrollment ongoing for Phase 3 registrational trial in patients with Lennox-Gastaut syndrome (LIGHTHOUSE Study) with topline data anticipated in 1H 2027 Safety and effectiveness data from the open-label extension study in DS was presented at AES meeting in December 2025 Fourth Quarter 2025 Financial Results Harmony Biosciences reported net product revenue of $243.8 million for the quarter ended December 31, 2025 , compared to $201.3 million for the same period in 2024, representing 22% year-over-year growth. This performance reflects both continued demand for WAKIX within the large narcolepsy market opportunity (approximately 80,000 diagnosed patients in the U.S. ) and the product's broad clinical utility. The continued success has been driven by strong execution across the organization from sales effectiveness to marketing and promotion and supported by broad payer coverage and how the company supports patients over time. On a GAAP basis, net income for the quarter was $22.5 million , or $0.38 per diluted share, compared to $49.5 million , or $0.85 per diluted share, in Q4 2024. Non-GAAP adjusted net income, which we believe better reflects our core business performance, was $33.4 million ( $0.57 per diluted share) for the fourth quarter of 2025 versus $64.2 million ( $1.10 per diluted share) for the comparable 2024 period. Reconciliations of applicable GAAP financial measures to Non-GAAP financial measures are included at the end of this press release. Harmony’s operating expenses include the following: Research and Development expenses were $49.9 million in the fourth quarter of 2025, as compared to $34.7 million for the same quarter in 2024, representing a 44% increase; Sales and Marketing expenses were $29.2 million in the fourth quarter of 2025, as compared to $27.6 million for the same quarter in 2024, representing a 6% increase; General and Administrative expenses were $57.6 million in the fourth quarter of 2025, as compared to $28.9 million for the same quarter in 2024, representing a 99% increase; and Total Operating Expenses were $136.7 million in the fourth quarter of 2025, as compared to $91.1 million for the same quarter in 2024, representing a 50% increase. Full Year 2025 Financial Results Net product revenues for the year ended December 31, 2025 , were $868.5 million , compared to $714.7 million for the same period in 2024. The 22% growth versus the same period in 2024 is primarily attributed to strong commercial sales of WAKIX driven by continued organic demand tapping into a large market opportunity (approximately 80,000 patients diagnosed with narcolepsy in the U.S. ) and the broad clinical utility of WAKIX across the approximately 9,000 HCPs that we call on (about 5,000 of whom do not participate in an oxybate REMS program). GAAP net income for the year ended December 31, 2025 , was $158.7 million , or $2.71 earnings per diluted share, compared to GAAP net income of $145.6 million , or $2.51 earnings per diluted share, for the same period in 2024. Non-GAAP adjusted net income was $211.0 million , or $3.60 earnings per diluted share, for the year ended December 31, 2025 , compared to Non-GAAP adjusted net income of $196.7 million , or $3.40 per diluted share, for the same period in 2024. Reconciliations of applicable GAAP financial measures to Non-GAAP financial measures are included at the end of this press release. Harmony’s operating expenses included the following: Research and Development expenses were $189.6 million for the year ended December 31, 2025 , as compared to $145.8 million for the prior year, representing a 30% increase. Sales and Marketing expenses were $119.5 million for the year ended December 31, 2025 , as compared to $110.9 million for the prior year, representing a 8% increase; General and Administrative expenses were $152.5 million for the year ended December 31, 2025 , as compared to $110.4 million for the prior year, representing a 38% increase; and Total Operating Expenses were $461.6 million for the year ended December 31, 2025 , as compared to $367.1 million for the prior year, representing a 26% increase. As of December 31, 2025 , Harmony had cash, cash equivalents and investments of $882.5 million , compared to $576.1 million as of December 31, 2024 . 2026 Net Product Revenue Guidance Reiterated 2026 WAKIX Net Revenue Guidance of $1.0 – $1.04B Conference Call Today at 8:30 a.m. ET We are hosting our fourth quarter 2025 financial results conference call and webcast today, beginning at 8:30 a.m. Eastern time . The live and replay webcast of the call will be available on the investor relations page of our website https://ir.harmonybiosciences.com/. To participate in the live call by phone, dial 800-274-8461 (domestic) or 203-518-9814 (international), and reference passcode HRMYQ425. Non-GAAP Financial Measures In addition to our GAAP results, we present certain Non-GAAP measures including Non-GAAP adjusted net income and Non-GAAP adjusted net income per share, which we believe provides important supplemental information to management and investors regarding our performance. These measurements are not a substitute for GAAP measurements, and the manner in which we calculate Non-GAAP adjusted net income and Non-GAAP adjusted net income per share may not be identical to the manner in which other companies calculate adjusted net income and adjusted net income per share. We use these Non-GAAP measurements as an aid in monitoring our financial performance from quarter-to-quarter and year-to-year and benchmarking against comparable companies. Non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that we may exclude for purposes of our Non-GAAP financial measures; and we may in the future cease to exclude items that we have historically excluded for purposes of our Non-GAAP financial measures. About WAKIX® (pitolisant) Tablets WAKIX, a first-in-class medication, is approved by the U.S. Food and Drug Administration for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy. It was granted orphan drug designation for the treatment of narcolepsy in 2010, and breakthrough therapy designation for the treatment of cataplexy in 2018. WAKIX is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. The mechanism of action of WAKIX is unclear; however, its efficacy could be mediated through its activity at H₃ receptors, thereby increasing the synthesis and release of histamine, a wake promoting neurotransmitter. WAKIX was designed and developed by Bioprojet ( France ). Harmony has an exclusive license from Bioprojet to develop, manufacture and commercialize pitolisant in the United States . Indications and Usage WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy. Important Safety Information Contraindications WAKIX is contraindicated in patients with known hypersensitivity to pitolisant or any component of the formulation. Anaphylaxis has been reported. WAKIX is also contraindicated in patients with severe hepatic impairment. Warnings and Precautions WAKIX prolongs the QT interval; avoid use of WAKIX in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval. Avoid use in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval. The risk of QT prolongation may be greater in patients with higher concentrations of pitolisant (e.g., patients with hepatic or renal impairment). Monitor patients with hepatic or renal impairment for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment. WAKIX is contraindicated in patients with severe hepatic impairment and not recommended in patients with end-stage renal disease (ESRD). Adverse Reactions In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and at least twice placebo) for WAKIX were insomnia (6%), nausea (6%), and anxiety (5%). Other adverse reactions that occurred at ≥2% and more frequently than in patients treated with placebo included headache, upper respiratory tract infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, decreased appetite, cataplexy, dry mouth, and rash. In the placebo-controlled phase of the clinical trial conducted in pediatric patients 6 years and older with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and greater than placebo) for WAKIX were headache (19%) and insomnia (7%). The overall adverse reaction profile of WAKIX in the pediatric clinical trial was similar to that seen in the adult clinical trial program. Drug Interactions Concomitant administration of WAKIX with strong CYP2D6 inhibitors increases pitolisant exposure by 2.2-fold. Reduce the dose of WAKIX by half. Concomitant use of WAKIX with strong CYP3A4 inducers decreases exposure of pitolisant by 50%. Dosage adjustments may be required. H1 receptor antagonists that cross the blood-brain barrier may reduce the effectiveness of WAKIX. Patients should avoid centrally acting H1 receptor antagonists. WAKIX is a borderline/weak inducer of CYP3A4. WAKIX may reduce the effectiveness of sensitive CYP3A4 substrates, including hormonal contraceptives. Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method during treatment with WAKIX and for at least 21 days after discontinuing treatment. Use in Specific Populations There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. Patients should be encouraged to enroll in the WAKIX pregnancy registry if they become pregnant. To enroll or obtain information from the registry, patients can call 1-800-833-7460. The safety and effectiveness of WAKIX have not been established for the treatment of excessive daytime sleepiness or cataplexy in pediatric patients less than 6 years of age with narcolepsy. WAKIX is extensively metabolized by the liver. WAKIX is contraindicated in patients with severe hepatic impairment. Dosage adjustment is required in patients with moderate hepatic impairment. WAKIX is not recommended in patients with end-stage renal disease. Dosage adjustment of WAKIX is recommended in patients with eGFR <60 mL/minute/1.73 m2. The maximum recommended dosage is lower in patients who are CYP2D6 poor metabolizers because these patients have higher pitolisant concentrations than CYP2D6 normal metabolizers and may have increased risk of adverse events. Please see the Full Prescribing Information for WAKIX for more information. To report suspected adverse reactions, contact Harmony Biosciences at 1-800-833-7460 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. About Narcolepsy Narcolepsy is a rare, chronic, debilitating neurological disease of sleep-wake state instability that impacts approximately 170,000 Americans and is primarily characterized by excessive daytime sleepiness (EDS) and cataplexy – its two cardinal symptoms – along with other manifestations of REM sleep dysregulation (hallucinations and sleep paralysis), which intrude into wakefulness. EDS is the inability to stay awake and alert during the day and is the symptom that is present in all people living with narcolepsy. In most patients, narcolepsy is caused by the loss of hypocretin/orexin, a neuropeptide in the brain that supports sleep-wake state stability. This disease affects men and women equally, with typical symptom onset in adolescence or young adulthood; however, it can take up to a decade to be properly diagnosed. About Idiopathic Hypersomnia Idiopathic Hypersomnia (IH) is a rare and chronic neurological disease that is characterized by excessive daytime sleepiness (EDS) despite sufficient or even long sleep time. EDS in IH cannot be alleviated by naps, longer sleep or more efficient sleep. People living with IH experience significant EDS along with the symptoms of sleep inertia (prolonged difficulty waking up from sleep) and 'brain fog' (impaired cognition, attention, and alertness). The cause of IH is unknown, but it is likely due to alterations in areas of the brain that stabilize states of sleep and wakefulness. IH is one of the central disorders of hypersomnolence and, like narcolepsy, is a debilitating sleep disorder that can result in significant disruption in daily functioning. About Clemizole Hydrochloride (EPX-100) EPX-100, clemizole hydrochloride, is under development for the treatment of Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). EPX-100 acts by targeting central 5-hydroxytryptamine receptors to modulate serotonin signaling. The drug candidate is administered orally twice a day in a liquid formulation and has been developed based on a proprietary phenotype-based zebrafish drug screening platform. DS is caused by a loss of function mutation in the SCN1A gene, and scn1 mutant zebrafish replicate the genetic etiology and phenotype observed in the majority of DS patients. The scn1Lab mutant zebrafish model that expresses voltage gated sodium channels has been used for high-throughput screening of compounds that modulate Nav1.1 in the central nervous system. About Dravet Syndrome Dravet syndrome (DS) is a severe and progressive epileptic encephalopathy that begins in infancy and causes significant impact on patient functioning. DS begins in the first year of life and is characterized by high seizure frequency and severity, intellectual disability, and a risk of sudden unexpected death in epilepsy. Approximately 85% of Dravet syndrome cases are caused by de novo loss-of-function (LOF) mutations in a voltage-gated sodium channel gene, SCN1A1. DS has an estimated incidence rate of 1:15,700. About Lennox-Gastaut Syndrome Lennox-Gastaut syndrome (LGS) is a rare and drug-resistant epileptic encephalopathy characterized by onset in children between 3-5 years of age. The underlying cause of LGS is unknown and can be related to a wide range of factors including genetic differences and structural differences in the brain. As a result, patients experience multiple seizure types, including atonic seizures, and developmental, cognitive, and behavioral issues. LGS affects approximately 48,000 patients in the U.S. About Harmony Biosciences Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC , in 2017 and headquartered in Plymouth Meeting, Pa. , we believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we foster. For more information, please visit www.harmonybiosciences.com. 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 2025 net product revenue, expectations for the growth and value of WAKIX, plans to submit an sNDA for pitolisant in idiopathic hypersomnia; our future results of operations and financial position, business strategy, products, prospective products, product approvals, the plans and objectives of management for future operations and future results of anticipated products. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX; the rate and degree of market acceptance and clinical utility of pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved, including EPX-100; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreements with Bioprojet Société Civile de Recherche (“Bioprojet”); the availability of favorable insurance coverage and reimbursement for WAKIX; the timing of, and our ability to obtain, regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and additional financing needs; our ability to identify, acquire and integrate additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; the significant costs and required management time as a result of operating as a public company; the fact that the price of Harmony's common stock may be volatile and fluctuate substantially; statements related to our intended share repurchases and repurchase timeframe; and macroeconomic effects and changes in market conditions, including the impact of tariffs, inflation and the risk of recession. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the " SEC ") on February 24, 2026 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARY CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (In thousands, except share and per share data) Three Months Ended December 31 , Year Ended December 31 , 2025 2024 2025 2024 Net product revenue $ 243,776 $ 201,267 $ 868,453 $ 714,734 Cost of product sold 68,545 54,409 198,342 156,815 Gross profit 175,231 146,858 670,111 557,919 Operating expenses: Research and development 49,933 34,666 189,594 145,825 Sales and marketing 29,179 27,600 119,512 110,916 General and administrative 57,562 28,865 152,536 110,352 Total operating expenses 136,674 91,131 461,642 367,093 Operating income 38,557 55,727 208,469 190,826 Other expense, net (105 ) 160 (680 ) (68 ) Interest expense (3,546 ) (4,209 ) (14,649 ) (17,496 ) Interest income 5,854 4,477 21,924 18,542 Income before income taxes 40,760 56,155 215,064 191,804 Income tax expense (18,274 ) (6,680 ) (56,377 ) (46,311 ) Net income $ 22,486 $ 49,475 $ 158,687 $ 145,493 Unrealized income on investments (11 ) (433 ) 280 64 Comprehensive income $ 22,475 $ 49,042 $ 159,967 $ 145,557 EARNINGS PER SHARE: Basic $ 0.39 $ 0.87 $ 2.76 $ 2.56 Diluted $ 0.38 $ 0.85 $ 2.71 $ 2.51 Weighted average number of shares of common stock - basic 57,634,656 57,097,092 57,492,277 56,885,455 Weighted average number of shares of common stock - diluted 58,696,342 58,218,052 58,544,570 57,869,915 HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share data) December 31 , December 31 , 2025 2024 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 752,502 $ 453,001 Investments, short-term 22,838 14,185 Trade receivables, net 96,787 83,033 Inventory, net 5,357 7,198 Prepaid expenses 16,014 13,714 Other current assets 13,516 8,121 Total current assets 907,014 579,252 NONCURRENT ASSETS: Investments, long-term 107,127 108,874 Intangible assets, net 89,418 113,263 Deferred tax asset 149,699 190,398 Other noncurrent assets 18,373 7,413 Total noncurrent assets 364,617 419,948 TOTAL ASSETS $ 1,271,631 $ 999,200 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Trade payables $ 17,693 $ 13,744 Accrued compensation 18,443 18,776 Accrued expenses 191,039 120,640 Current portion of long-term debt 20,000 16,250 Other current liabilities 4,957 5,672 Total current liabilities 252,132 175,082 NONCURRENT LIABILITIES: Long-term debt, net 143,663 163,016 Other noncurrent liabilities 5,618 1,947 Total noncurrent liabilities 149,281 164,963 TOTAL LIABILITIES 401,413 340,045 COMMITMENTS AND CONTINGENCIES (Note 13) STOCKHOLDERS’ EQUITY: Common stock—$0.00001 par value; 500,000,000 shares authorized at December 31, 2025 and December 31, 2024 , respectively; 57,726,170 and 57,144,887 shares issued and outstanding at December 31, 2025 and December 31, 2024 , respectively 1 1 Additional paid in capital 708,968 656,872 Accumulated other comprehensive income 346 66 Retained earnings 160,903 2,216 TOTAL STOCKHOLDERS’ EQUITY 870,218 659,155 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 1,271,631 $ 999,200 HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS (In thousands except share and per share data) Three Months Ended Year Ended December 31 , December 31 , December 31 , December 31 , 2025 2024 2025 2024 GAAP net income (1) $ 22,486 $ 49,475 $ 158,687 $ 145,493 Non-GAAP Adjustments: Non-cash interest expense (2) 157 169 647 700 Depreciation 1,470 6 1,490 267 Amortization (3) 5,962 5,962 23,845 23,845 Stock-based compensation expense 10,292 9,856 44,960 42,701 Income tax effect related to non-GAAP adjustments (4) (6,988) (1,227) (18,587) (16,271) Non-GAAP adjusted net income (1) $ 33,379 $ 64,241 $ 211,042 $ 196,735 GAAP reported net income per diluted share $ 0.38 $ 0.85 $ 2.71 $ 2.51 Non-GAAP adjusted net income per diluted share $ 0.57 $ 1.10 $ 3.60 $ 3.40 Weighted average number of shares of common stock used in non-GAAP diluted per share 58,696,342 58,218,052 58,544,570 57,869,915 (1) Includes a $4,250 IPR&D charge related to a clinical milestone achieved for BP1.15205 during the three months and year ended December 31, 2025 . Includes a $15,000 IPR&D charge related to a clinical milestone achieved for ZYN002 and a $15,000 IPR&D charge related to an upfront fee incurred upon closing the CiRC research collaboration agreement during the year ended December 31, 2025 . Includes a Includes a $25,500 charge related to an upfront license fee incurred upon closing the 2024 Bioprojet Sublicense Agreement, a $17,095 IPR&D charge related to the acquisition of Epygenix, and a $1,000 IPR&D charge related to a preclinical milestone achieved for HBS-102 during the year ended December 31, 2024 . (2) Includes amortization of deferred finance charges. (3) Includes amortization of intangible asset related to WAKIX. (4) Calculated using the reported effective tax rate for the periods presented less impact of discrete items. View source version on businesswire.com: https://www.businesswire.com/news/home/20260224164879/en/ Harmony Biosciences Investor Contact: Matthew Beck 917-415-1750 matthew.beck@astrpartners.com Harmony Biosciences Media Contact: Cate McCanless 202-641-6086 cmccanless@harmonybiosciences.com Source: Harmony Biosciences Holdings, Inc.