Supernus Pharmaceuticals Inc 2024年度报告

Dear Supernus Stockholder, We are pleased with our 2024 results which reflect solid commercial execution across the company, includingcontinued growth of our core products and strong growth in operating earnings. This performanceunderscored our emphasis on growing our core business through a multi-year transition due to the loss ofexclusivity on both Trokendi XR®and Oxtellar XR®. Total revenues excluding Trokendi XR and Oxtellar XRincreased by 25% for the full year 2024. In addition, we continue to generate strong cash flows behind thestrength of our portfolio, particularly our core products, and through the efficiency of our operations. Qelbree®—A Novel Non-Stimulant ADHD Product 2024 represented another strong year of growth for Qelbree, with all-time quarterly and yearly highs forprescriptions and annual net sales. As a well-differentiated product that is a non-controlled medication,Qelbree provides a novel and unique treatment option for the millions of pediatric and adult patients whosuffer from ADHD. For full year 2024, Qelbree’s prescriptions as reported by IQVIA increased 25% compared to 2023, while netsales recorded a strong growth rate of 72% benefiting from the prescription growth and the steadyimprovement in gross to net throughout the year. 2025 is off to a strong start for Qelbree, supported by theU.S. Food and Drug Administration (FDA) approval of its updated label, further elaborating on Qelbree’sdifferentiated mechanism of action as a non-stimulant reinforcing its multimodal pharmacodynamicprofile and highlighting its unique partial agonist activity at the serotonin 5-HT2C receptor and inhibitionof the norepinephrine transporter. In addition, during 2024, we presented encouraging interim results from an open-label Phase IV trial withQelbree in adult patients with ADHD and mood symptoms at the Annual National PsychopharmacologyUpdate conference. Qelbree demonstrated improvements in clinician and patient-rated measures of ADHD,depression and anxiety symptoms. Finally, and importantly, we received a two-plus year patent term extension from the U.S. Patent andTrademark Office for one of the US Patents that covers Qelbree. This extends the original expiration date ofthe patent to the year 2035. Additional Highlights and Achievements We continue to be pleased with the performance of GOCOVRI®based on its unique position in themarketplace treating both off episodes and dyskinesia. In 2024, net sales increased by 9% reaching a recordof approximately $130 million. We have also achieved an important milestone for patients in February 2025 with the approval by the FDAof ONAPGO™, our next growth product. It is the first and only subcutaneous apomorphine infusion devicefor the treatment of motor fluctuations in adults with advanced Parkinson’s disease. We are targeting thelaunch of ONAPGO in the second quarter of 2025 with a support team of experts, including a nurseeducation program and access support. ONAPGO fits very well within our portfolio as it utilizes our existingParkinson’s disease sales force and infrastructure. Regarding our pipeline, in 2024, we reported topline results from an open-label Phase 2a study withSPN-817 in patients with treatment-resistant seizures. SPN-817 was safe with acceptable tolerability anddisplayed a differentiated profile, with strong efficacy in focal seizures at the 3 milligram to 4 milligram twicedaily doses. Stage B of the Phase 2a study is ongoing and we have initiated a Phase 2b randomizeddouble-blind, placebo-controlled study of SPN-817 with targeted enrollment of approximately 258 adultpatients with treatment-resistant focal seizures. We also completed a pharmacokinetic study of two oralformulations of SPN-443, a new stimulant-like product candidate for ADHD and other CNS disorders inhealthy adults; both formulations showed adequate bioavailability and were well tolerated. In February 2025, we disclosed that the Phase 2b study of SPN-820 in adults with treatment-resistant depression did notdemonstrate a statistically significant improvement on the primary and secondary endpoints versus placebo.The safety profile of SPN-820 in this study was consistent with previous clinical trials showing few adverseevents. We will continue to analyze the data and decide on the future of the program. 2025 Key Milestones We finished 2024 in a position of strength with both Qelbree and GOCOVRI achieving record sales andpromising developments from some of our pipeline products. We believe we are well positioned for continuedgrowth beyond the current transition and are focused on three key strategic areas: •Launching and driving growth for ONAPGO, the only subcutaneous apomorphine infusion devicefor the treatment of motor fluctuations in adults with advanced Parkinson’s disease, beginning in thesecond quarter of 2025.•Driving significant growth with Qelbree and GOCOVRI, and together with the rest of the portfolio,generating strong cash flow allowing us to continue our