Safinamide mesylate

MILAN & MORRISTOWN, N.J.--(BUSINESS WIRE)-- $NWRN #Biotech -- Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), today announced that Stefan Weber, CEO and Roberto Galli, CFO , will participate in the following investor conferences in June: Jefferies Global Healthcare Conference , June 2–4, 2026, New York H.C. Wainwright 7th Annual Neuro Perspectives Hybrid Conference , June 15–16, 2026, Virtual At the Jefferies Global Healthcare Conference, members of the Newron management team will participate in a corporate presentation and one-on-one investor meetings. The corporate presentation will take place on Thursday, June 4, 2026, at 2:00 p.m. ET. At the H.C. Wainwright conference, members of the Newron team will participate virtually in a corporate presentation and one-on-one investor meetings. The pre-recorded corporate presentation will be available on-demand to registered conference attendees starting on June 15, 2026 at 7:00 A.M. (ET). To schedule a meeting with management during the conferences, please contact Casey Darby at cdarby@lavoiegroup.com . About Newron Pharmaceuticals Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of innovative therapies for patients with diseases of the central and peripheral nervous system. Headquartered in Bresso, near Milan, Italy, the Company has a strong track record of advancing neuroscience-based treatments from discovery to market. Newron’s lead compound, evenamide, is a first-in-class glutamate modulator and has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently developed in the global pivotal ENIGMA-TRS Phase III development program. Clinical trial results to date demonstrate the benefits of this drug candidate in the TRS as well as poorly responding patient population, with significant improvements across key efficacy measures increasing over time, as well as a favorable safety profile, which is uncommon for available antipsychotic medications. Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. Newron’s first marketed product, Xadago® (safinamide) has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan, and South Korea. The product is commercialized by Newron’s partner, Zambon, with Supernus Pharmaceuticals holding marketing rights in the USA, and Meiji Seika responsible for development and commercialization in Japan and other key Asian territories. For more information, please visit: and connect with us on LinkedIn . Contacts Newron Stefan Weber – CEO +39 02 6103 46 26 pr@newron.com UK/Europa Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting +44 20 3727 1000 SCnewron@fticonsulting.com Switzerland Valentin Handschin, IRF +41 43 244 81 54 handschin@irf-reputation.ch Germany/Europa Anne Hennecke / Maximilian Schur, MC Services +49 211 52925227 newron@mc-services.eu USA Casey Darby, LaVoieHealthScience +1 617 351 0244 cdarby@lavoiegroup.com

Total revenues were $207.7 million in the first quarter 2026, a 39% increase compared to same period last year. Combined revenues of the Company's four growth products increased to $149.1 million in the first quarter 2026, representing an increase of 56% compared to the same period last year. This strong growth was driven by an increase in net sales of Qelbree® and GOCOVRI®, and the addition of sales from ZURZUVAE® and ONAPGO™. Regulatory submission to the FDA for second supplier for ONAPGO expected in third quarter 2026, with potential approval by mid-year 2027. The Company reiterates full year 2026 financial guidance. ROCKVILLE, Md. , May 05, 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 first quarter 2026 and associated Company developments. “Our first quarter results reflect a strong start to the year, including a 56% year-over-year increase in combined revenues of our growth products,” said Jack Khattar , President and CEO of Supernus. “We have positive momentum across our business, and I look forward to continued strong growth and execution of our key products throughout the year.” Commercial Highlights ONAPGO net product sales were $8.4 million in the first quarter of 2026, reflecting resumption of new patient initiation in February 2026 . Since the launch in April 2025 , and through the end of April 2026 , approximately 2,200 enrollment forms have been submitted by more than 645 prescribers. The Company expects to file a regulatory submission to the U.S. Food and Drug Administration (FDA) for a second supplier for ONAPGO in the third quarter of 2026, with potential FDA approval for the second supplier by mid-year 2027. Collaboration revenue from ZURZUVAE was $27.6 million in the first quarter of 2026. Collaboration revenue represents 50% of the net revenues for ZURZUVAE recorded by Biogen Inc. First quarter 2026 U.S sales of ZURZUVAE, as reported by Biogen Inc., increased approximately 100% compared to the same period in 2025. The total number of prescriptions for ZURZUVAE increased by 82% in the first quarter of 2026 compared to the same period last year. Net sales of Qelbree increased 20% to $77.9 million in the first quarter of 2026, compared to the same period in 2025, driven primarily by volume growth. Total IQVIA prescriptions(6) for Qelbree were 254,824 for the first quarter 2026, representing an increase of 19% compared to the same period last year. The total number of prescribers reached an all-time high of approximately 43,000 in the first quarter of 2026. Net sales of GOCOVRI increased 15% to $35.2 million in the first quarter of 2026, compared to the same period in 2025. Total number of prescriptions grew by 7% in the first quarter of 2026 compared to the same period last year. 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 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): Total revenues from commercial products (non-GAAP)(1)(4) represent revenues from our product sales to customers and through our collaboration agreement with Biogen. Other Financial Highlights The Company recognized $20.0 million of licensing revenue in the first quarter of 2026 related to the achievement of a commercial milestone under its collaboration agreement with Shionogi. Operating loss was $8.3 million for the first quarter of 2026, compared to an operating loss of $10.3 million for the same period in 2025. The change was primarily due to higher revenues and a lower change in contingent consideration loss in the 2026 period, partially offset by an increase in selling, general, and administrative expenses associated with the collaboration agreement with Biogen Inc., an increase in research and development costs related to clinical program costs on SPN-817, which includes a $10.0 million expense to former Biscayne security holders, and an increase in intangible asset amortization expense for ZURZUVAE and ONAPGO intangible assets in 2026. Adjusted operating earnings (non-GAAP)(1) were $28.7 million in the first quarter of 2026, compared to $25.9 million for the same period in 2025. Net loss and diluted loss per share were $2.3 million and $0.04 for the first quarter of 2026, respectively, compared to net loss and diluted loss per share of $11.8 million and $0.21 for the same period in 2025. Cash, cash equivalents, and current marketable securities were approximately $384.2 million as of March 31, 2026 , compared to $308.7 million as of December 31, 2025 . This increase was primarily due to cash generated from operations and the aforementioned commercial milestone. Full Year 2026 Financial Guidance For the full year 2026, the Company reiterates its full year financial guidance as set forth below (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. 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 also present total revenues from commercial products, which is also a non-GAAP measure and is calculated as the combined total of total net product sales (GAAP) and collaboration revenues (GAAP). 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. End Notes__________________________(1) See the section titled "Non-GAAP Financial Information" for information about this non-GAAP financial measure. A reconciliation of each non-GAAP financial measure to the most directly comparable GAAP financial measure is included at the end of this press release.(2) Includes net product sales of MYOBLOC®, XADAGO® and Osmolex ER®.(3) Represents proportionate share of collaboration revenue from Biogen’s sales of ZURZUVAE to customers in the U.S. from July 31, 2025 , the closing of the acquisition of Sage Therapeutics, Inc. (4) Total revenues from commercial products, a non-GAAP measure, represents revenues from our product sales to customers and through our collaboration agreement with Biogen. (5) Royalty, licensing, and other revenues include royalties on generic Trokendi XR, Oxtellar XR, other licensed products and intellectual property.(6) IQVIA data restatement July 1, 2025 .(7) Includes net product sales, collaboration revenue, and royalty, licensing, and other revenue. Conference Call Details Supernus will host a conference call and webcast today, May 5, 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. __________________________(a) Excludes amortization of intangible assets. 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): __________________________(a) Includes net product sales, collaboration revenue, and royalty, licensing, and other revenues. Reconciliation of GAAP Net Product Sales to Non-GAAP Revenues from Commercial Products An itemized reconciliation between Net product sales on a GAAP basis and total revenues from commercial products, a non-GAAP measure, is as follows (dollars in millions): Total revenues from commercial products, a non-GAAP measure, represents revenues from our product sales to customers and through our collaboration agreement with Biogen. 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 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.