Financial Performance - ONAPGO generated net product sales of $6.8 million in its first full quarter following the U.S. commercial launch in April 2025, with over 1,300 enrollment forms submitted by more than 450 prescribers[216]. - Collaboration revenue from ZURZUVAE was $20.2 million in Q3 2025, representing approximately two months of collaboration revenue since the Sage Acquisition, with U.S. sales increasing approximately 150% compared to the same period in 2024[216]. - Net sales of Qelbree increased 31% to $81.4 million in Q3 2025, with total IQVIA prescriptions reaching 238,770, a 23% increase year-over-year[216]. - Net sales of GOCOVRI increased 15% to $40.8 million in Q3 2025, driven by growth in prescriptions and the number of prescribers[216]. - Total revenues for Q3 2025 were $192.1 million, a 9% increase from $175.7 million in Q3 2024, while total revenues for the nine months ended September 30, 2025, were $507.4 million, up 4% from $487.7 million in the same period of 2024[235]. - Net product sales decreased by 1% to $168.5 million in Q3 2025 compared to $170.3 million in Q3 2024, and also decreased by 1% to $468.5 million for the nine months ended September 30, 2025, from $471.3 million in the prior year[236]. - The decline in net product sales was primarily due to lower sales of APOKYN (down 48% in Q3 2025) and Oxtellar XR (down 60% in Q3 2025) due to generic erosion, partially offset by increases in sales from Qelbree and GOCOVRI[236]. Acquisitions and Collaborations - The Company completed the acquisition of Sage Therapeutics, Inc. on July 31, 2025, integrating its established commercial product ZURZUVAE into its portfolio[203]. - Collaboration revenue (ZURZUVAE) was $20.2 million for the three and nine months ended September 30, 2025, attributed to the Sage Acquisition in July 2025[248]. - The company has contingent consideration milestones related to the Sage Acquisition, with potential payments totaling up to $234 million based on future sales of ZURZUVAE[272]. - The company incurred $70.9 million in acquisition-related costs associated with the Sage Acquisition in July 2025, contributing to the decline in earnings[266]. Product Development - SPN-817, a novel anticonvulsant for epilepsy, is currently in a Phase 2b study with a targeted enrollment of approximately 258 adult patients[213]. - SPN-820, a novel treatment for depression, plans to initiate a follow-on Phase 2b trial in approximately 200 adults with major depressive disorder by the end of 2025[214]. - SPN-443, a novel stimulant for ADHD, completed a Phase 1 study in 2024 and is expected to initiate a Phase 1 single-ascending/multiple ascending dose study in 2026[215]. - The FDA approved an expanded label update for Qelbree in January 2025, including new data on pharmacodynamics and use in breastfeeding mothers[205]. Inventory and Supply Chain - The Company is facing supply constraints for ONAPGO due to stronger than expected demand, prioritizing care for existing patients while working to build adequate inventory[216]. - The accrued product returns balance decreased to $43.3 million as of September 30, 2025, from $57.4 million as of September 30, 2024, primarily due to a $16.3 million estimated provision for product returns related to prior year sales[244]. - The accrued product rebates balance increased to $141.2 million as of September 30, 2025, from $111.7 million as of September 30, 2024, primarily due to the timing of payments associated with government programs[245]. Expenses and Financial Management - Selling and marketing expenses increased by 42% to $54.3 million for the three months ended September 30, 2025, and by 19% to $205.5 million for the nine months ended September 30, 2025, primarily due to higher professional and consulting expenses[252]. - General and administrative expenses surged by 565% to $15.4 million for the three months ended September 30, 2025, and by 127% to $157.7 million for the nine months ended September 30, 2025, mainly due to acquisition-related costs from the Sage acquisition[253]. - Research and Development (R&D) expenses were $29.4 million for the three months ended September 30, 2025, compared to $29.0 million in 2024, with a total of $78.4 million for the nine months ended September 30, 2025, down from $80.1 million in 2024[251]. - The provision for product rebates increased to $295.1 million for the nine months ended September 30, 2025, from $293.6 million in the same period of 2024, primarily due to higher Qelbree sales[247]. Cash Flow and Liquidity - Cash and cash equivalents increased to $151.4 million as of September 30, 2025, from $69.3 million as of December 31, 2024, representing a 118% increase[261]. - Total cash, cash equivalents, and unrestricted marketable securities amounted to $281.2 million as of September 30, 2025, which the company believes will be sufficient to meet cash requirements over the next 12 months[262]. - Net cash provided by operating activities decreased to $27.5 million in 2025 from $127.5 million in 2024, primarily due to a net loss of $34.4 million compared to net earnings of $58.5 million in the prior year[266]. - Net cash provided by investing activities was $55.4 million in 2025, a significant improvement from net cash used of $177.2 million in 2024, primarily due to higher inflows from marketable securities[267]. - Cash and cash equivalents at the end of the period increased to $152.8 million in 2025 from $31.7 million in 2024, reflecting a net change of $126.9 million[265]. Risk Management and External Factors - The company does not hedge foreign currency exchange rate risk, and all liabilities were substantially denominated in U.S. dollars as of September 30, 2025[281]. - Inflation has not significantly impacted the company's consolidated results, although there are expectations of variability in labor and vendor service costs due to uncontrollable factors[282].
Supernus Pharmaceuticals(SUPN) - 2025 Q3 - Quarterly Report