Zuranolone

Record total revenues of $211.6 million and $719.0 million in the fourth quarter and full year 2025, a 21% and 9% increase compared to same periods last year. Combined revenues of the Company's four growth products increased to $161.3 million and $521.8 million in the fourth quarter and full year 2025, representing year-over-year growth of 45% and 40% respectively. The strong growth in both periods was driven by an increase in net sales of Qelbree® and GOCOVRI®, and the addition of sales from ZURZUVAE® and ONAPGO™. Cash, cash equivalents and current marketable securities were $308.7 million at December 31, 2025 . New patient initiation for ONAPGO resumed in the first quarter of 2026. Full year 2026 guidance for total revenues of $840 million to $870 million , operating earnings of $0 million to $30 million , and adjusted operating earnings (Non-GAAP)(1) of $140 million to $170 million . ROCKVILLE, Md. , Feb. 24, 2026 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the fourth quarter and full year 2025 and associated Company developments. "We made significant progress in 2025 against our strategic objectives, with record total revenues, including strong growth in combined revenues of our growth products, the successful acquisition of Sage Therapeutics, Inc. , and the U.S. Food and Drug Administration's approval and launch of ONAPGO for Parkinson's disease," said Jack Khattar , President and CEO of Supernus. "In 2026, we are focused on continued progress of our key growth products, including resumption of new patient initiation for ONAPGO, while advancing our pipeline of promising therapeutic candidates." Commercial Highlights The Company has made progress securing additional product supply of ONAPGO from the current supplier and as a result has resumed new patient initiation. In addition, the Company is working with a second supplier, which is expected to begin supplying ONAPGO in 2027. ONAPGO net product sales were $8.9 million in the fourth quarter of 2025 following the U.S. commercial launch in April 2025 . Since launch, more than 1,800 enrollment forms have been submitted by over 540 prescribers. Collaboration revenue from ZURZUVAE was $32.8 million in the fourth quarter of 2025. Collaboration revenue (ZURZUVAE) represents 50% of the net revenues for ZURZUVAE recorded by Biogen Inc. Fourth quarter 2025 U.S sales of ZURZUVAE, as reported by Biogen Inc., increased approximately 187% compared to the same period in 2024 and approximately 19% compared to the third quarter of 2025. The total number of prescriptions for ZURZUVAE increased by more than 150% in 2025 compared to 2024. Net sales of Qelbree increased 9% to $81.0 million in the fourth quarter of 2025, compared to the same period in 2024, driven primarily by volume growth and partially offset by an annual gross-to-net deduction that was reflected in fourth quarter 2025. Total IQVIA prescriptions(5) for Qelbree were 253,742 for the fourth quarter 2025, representing an increase of 18% compared to the same period in the prior year. Net sales of GOCOVRI increased 5% to $38.6 million in the fourth quarter of 2025, compared to the same period in 2024. Total number of prescriptions grew by 14% in 2025 compared to 2024. Product Pipeline Update SPN-817 – Novel first-in-class highly selective AChE inhibitor for epilepsy The Phase 2b randomized, double-blind, placebo-controlled study of 3mg and 4mg twice daily doses is ongoing with a targeted enrollment of approximately 258 adult patients with treatment resistant focal seizures. SPN-820 – Novel first-in-class molecule that increases mTORC1 mediated synaptic function for depression The Company initiated a follow-on Phase 2b multi-center, randomized, double-blind, placebo-controlled trial in approximately 200 adults with major depressive disorder (MDD). The study will examine the safety and tolerability of SPN-820 2400 mg given intermittently (twice weekly) as an adjunctive treatment to the current baseline antidepressant therapy, as well as assess the rapid onset of improvement in depressive symptoms. SPN-443 – Novel stimulant for attention-deficit/hyperactivity disorder (ADHD) The Company expects to initiate a Phase 1 single-ascending/multiple-ascending dose study in adult healthy volunteers in the second half of 2026. Financial Highlights This section includes information on non-GAAP financial measures. See "Non-GAAP Financial Information" section for information on non-GAAP financial measures. In addition, a reconciliation of applicable GAAP to non-GAAP financial information is included at the end of this press release. Revenues The following table provides information regarding total revenues (dollars in millions): Other Financial Highlights The Company recognized $15.0 million of licensing revenue in the fourth quarter of 2025 related to the achievement of a regulatory milestone under its collaboration agreement with Shionogi. Operating loss was $4.0 million and $62.3 million for the three and twelve months ended December 31, 2025 , compared to operating earnings of $21.4 million and $81.7 million for the same periods in 2024. The change in both periods was primarily due to higher selling, general and administrative expenses, including approximately $72.9 million of acquisition-related costs associated with the Sage acquisition reported in 2025, change in contingent consideration loss (gain), and incremental intangible asset amortization expense for ZURZUVAE and ONAPGO intangible assets in 2025, partially offset by higher revenues. Adjusted operating earnings (non-GAAP)(1) were $48.5 million and $158.7 million for the three and twelve months ended December 31, 2025 , compared to $48.3 million and $183.7 million for the same periods in 2024. Net loss and diluted loss per share were $4.1 million and $0.07 for the three months ended December 31, 2025 , and $38.6 million and $0.68 for the twelve months December 31, 2025 , respectively, compared to net earnings and diluted earnings per share of $15.3 million and $0.27 for the three months ended December 31, 2024 , and $73.9 million and $1.32 for the twelve months December 31, 2024 , respectively. Cash, cash equivalents, and current marketable securities were approximately $308.7 million as of December 31, 2025 , compared to $453.6 million as of December 31, 2024 . This decrease was primarily due to the funding of the Sage acquisition, partially offset by cash generated from operations. Full Year 2026 Financial Guidance The Company expects to achieve the following financial objectives in 2026 (dollars in millions): Non-GAAP Financial Information This press release contains financial measures that present financial information which do not comply with United States generally accepted accounting principles (GAAP). The non-GAAP financial measures should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP. Non-GAAP adjusted operating earnings on a historical and projected basis adjusts for non-cash share-based compensation expense, depreciation and amortization, intangible asset impairment charges and changes to fair value of contingent consideration, and for factors that are unusual, non-recurring or unpredictable, and excludes those costs, expenses, and other specified items presented in the reconciliation tables in this press release. In addition to non-GAAP adjusted operating earnings, we also present total revenues excluding net sales of Trokendi XR (GAAP) and Oxtellar XR (GAAP), which is a non-GAAP measure and is calculated as total revenues (GAAP) less net product sales of Trokendi XR (GAAP) and Oxtellar XR (GAAP). Beginning in the year a product loses exclusivity due to generic entrants, we generally do not expect net product sales of such products to constitute a significant part of our revenue in the future. We believe that the use of non-GAAP financial measures provides useful supplemental information to management, investors, analysts and others regarding the Company's revenue and results of operations and assist management, investors, analysts, and others in understanding and evaluating our revenue growth and the performance of the business. There are limitations associated with the use of non-GAAP financial measures and therefore comparability may be limited. These limitations include: non-GAAP financial measures that may not be entirely comparable to similarly titled measures used by other companies; these may not reflect all items of income and expense, as applicable, that affect our operations; there may be potential differences among calculation methodologies; these may differ from the non-GAAP information used by other companies, including peer companies. We mitigate these limitations by reconciling the non-GAAP financial measure to the most comparable GAAP financial measure. Investors are encouraged to review the reconciliation. The Company's 2026 financial guidance is also being provided on both a GAAP and a non-GAAP basis. Conference Call Details Supernus will host a conference call and webcast today, February 24, 2026 , at 4:30 p.m. Eastern Time to discuss these results. A live webcast will be available in the Events & Presentations section of the Company's Investor Relations website www.supernus.com/investors. Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time. Following the live call, a replay will be available on the Company's Investor Relations website www.supernus.com/investors. The webcast will be available on the Company's website for 60 days following the live call. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for attention-deficit hyperactivity disorder (ADHD), dyskinesia in Parkinson's disease (PD) patients receiving levodopa-based therapy, hypomobility in PD, postpartum depression (PPD), epilepsy, migraine, cervical dystonia, and chronic sialorrhea. We are developing a broad range of novel product candidates for CNS disorders. For more information, please visit www.supernus.com. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company's ability to sustain and increase its profitability; the Company's ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company's corporate strategy; the Company's future financial performance and projected expenditures; the Company's ability to increase the number of prescriptions written for each of its products, and the products of its subsidiaries; the Company's ability to increase its net revenue from its products, and the products of its subsidiaries; the Company's ability to commercialize its products, and the products of its subsidiaries; the Company's ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company's product research and development activities, including the timing and progress of the Company's clinical trials, and projected expenditures; the Company's ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company's product candidates; the Company's ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company's expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company's product candidates; the accuracy of the Company's estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company's ability to increase its manufacturing capabilities for its products and product candidates; the Company's projected markets and growth in markets; the Company's product formulations and patient needs and potential funding sources; the Company's staffing needs; changes to laws and regulations applicable to our industry, the impact of macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs; and other risk factors set forth from time to time in the Company's filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events. Supernus Pharmaceuticals, Inc. Reconciliations of GAAP to Non-GAAP Financial Information(unaudited) Reconciliation of GAAP Total revenues to Non-GAAP Total revenues excluding Trokendi XR and Oxtellar XR net sales An itemized reconciliation between total revenues on a GAAP basis and Total revenues excluding Trokendi XR and Oxtellar XR net sales, a non-GAAP measure, is as follows (dollars in millions): Reconciliation of GAAP Operating Earnings (Loss) to Non-GAAP Adjusted Operating Earnings An itemized reconciliation between operating earnings (loss) on a GAAP basis and adjusted operating earnings on a non-GAAP basis is as follows (dollars in millions): Non-GAAP adjusted operating earnings adjusts for one-time acquisition related costs and non-cash items, which include amortization of intangible assets, share-based compensation expense, change in fair value of contingent consideration, and depreciation. Reconciliation of Full Year 2026 Financial Guidance – GAAP Operating Earnings to Non-GAAP Adjusted Operating Earnings An itemized reconciliation between projected operating earnings on a GAAP basis for the full year 2026 and projected adjusted operating earnings on a non-GAAP basis for the full year 2026 is as follows (dollars in millions): CONTACTS: Jack A. Khattar , President and CEO Timothy C. Dec , Senior Vice President and CFO Supernus Pharmaceuticals, Inc. (301) 838-2591 or INVESTOR CONTACT: Peter Vozzo ICR Healthcare (443) 213-0505peter.vozzo@icrhealthcare.com Source: Supernus Pharmaceuticals, Inc.