ZURZUVAE (zuranolone)

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Supernus Announces Second Quarter 2025 Financial Results
Globenewswire· 2025-08-05 20:05
Core Insights - Supernus Pharmaceuticals reported strong operating performance in Q2 2025, driven by significant sales growth of Qelbree and GOCOVRI, which together accounted for 72% of total net sales [2][5] - The company completed the acquisition of Sage Therapeutics on July 31, 2025, enhancing its portfolio in neuropsychiatric conditions with the innovative product ZURZUVAE and a novel CNS discovery platform [3][5] - Supernus is focused on the launch of ONAPGO and the integration of Sage Therapeutics while continuing to drive growth from existing products [2][3] Financial Performance - Qelbree net sales increased by 31% year-over-year to $77.6 million in Q2 2025, with total sales for the first half of 2025 reaching $142.3 million [5][11] - GOCOVRI net sales rose by 16% year-over-year to $36.7 million in Q2 2025, totaling $67.4 million for the first half of 2025 [5][11] - Total revenues for Q2 2025 were $165.5 million, a slight decrease from $168.3 million in Q2 2024, while total revenues for the first half of 2025 were $315.3 million, up from $312.0 million in the same period last year [11][12] Product Pipeline and Developments - The company is conducting a Phase 2b study for SPN-817, a novel AChE inhibitor for epilepsy, with a targeted enrollment of approximately 258 patients [7] - SPN-820, a novel molecule for depression, is set to enter a Phase 2b trial by the end of 2025, targeting around 200 adults with major depressive disorder [8] - SPN-443, a novel stimulant for ADHD/CNS, has completed a Phase 1 pharmacokinetic study, with plans to disclose a lead indication by the end of 2025 [9] Guidance and Future Outlook - Supernus updated its full-year 2025 revenue guidance to $670 - $700 million, reflecting strong first-half performance and the impact of the Sage acquisition [13][20] - The company anticipates combined R&D and SG&A expenses to be between $505 - $530 million for the year [13] - Adjusted operating earnings guidance for 2025 is projected to be between $105 - $135 million, consistent with previous expectations [13][37]
Supernus Pharmaceuticals Completes Acquisition of Sage Therapeutics
Globenewswire· 2025-07-31 12:44
Core Viewpoint - The acquisition of Sage Therapeutics by Supernus Pharmaceuticals enhances its position in neuropsychiatric conditions, introducing the innovative product ZURZUVAE® and a new CNS discovery platform, which is expected to drive revenue and cash flow growth while diversifying the revenue base [1][2]. Acquisition Details - Supernus completed the acquisition of Sage for $8.50 per share in cash, plus a contingent value right (CVR) that could yield up to an additional $3.50 per share based on specific milestones [3][4]. - A total of 36,313,509 shares, representing approximately 58% of Sage's outstanding shares, were validly tendered in the offer [10]. Strategic Rationale - The acquisition adds a significant fourth growth product to Supernus's portfolio, expected to be accretive in 2026 due to anticipated cost synergies of up to $200 million annually [2][7]. - ZURZUVAE is the first FDA-approved oral medication for postpartum depression, which strengthens Supernus's psychiatry portfolio [7]. Milestone Payments - The CVR includes milestone payments based on ZURZUVAE's commercial success, including: - $0.50 per CVR upon the first commercial sale in Japan by June 30, 2026 [5]. - $1.00 per CVR if U.S. net sales reach $250 million by December 31, 2027 [6]. - $1.00 per CVR if U.S. net sales reach $300 million by December 31, 2028 [8]. - $1.00 per CVR if U.S. net sales reach $375 million by December 31, 2030 [8]. Company Overview - Supernus Pharmaceuticals focuses on developing and commercializing products for CNS diseases, with a diverse portfolio that includes treatments for ADHD, Parkinson's disease, postpartum depression, and more [13][14].
ZURZUVAE® (zuranolone) Receives Positive Opinion from CHMP for the Treatment of Women with Postpartum Depression
Globenewswire· 2025-07-25 11:20
Core Viewpoint - Biogen Inc. announced a positive opinion from the CHMP recommending marketing authorization for ZURZUVAE (zuranolone) for treating postpartum depression (PPD) in adults, which could be the first EU-approved treatment specifically for PPD if approved by the European Commission [1][5]. Company Summary - Biogen is a leading biotechnology company founded in 1978, focusing on innovative science to develop new medicines and create shareholder value [8]. - The company collaborates with Sage Therapeutics for the development and commercialization of ZURZUVAE, holding exclusive rights outside the U.S. [7]. Product Summary - ZURZUVAE is a once-daily, oral, 14-day treatment for PPD, approved by the FDA in 2023, and is a neuroactive steroid that modulates GABA-A receptors [6]. - The treatment has shown potential for symptom improvement as early as day three of a 14-day course, with significant reductions in depressive symptoms observed [2][4]. Market Opportunity - An estimated 5-20% of women experience PPD symptoms in Europe, with many cases going undiagnosed due to varying clinical guidelines [3]. - The recommendation for ZURZUVAE is based on the SKYLARK Study, which demonstrated significant efficacy in reducing depression severity compared to placebo [4].
Supernus Pharmaceuticals to Acquire Sage Therapeutics, Strengthening its Neuropsychiatry Product Portfolio
Globenewswire· 2025-06-16 11:00
Core Viewpoint - Supernus Pharmaceuticals is acquiring Sage Therapeutics for $8.50 per share in cash, totaling approximately $561 million, with additional contingent value rights (CVR) potentially increasing the total consideration to $12.00 per share, or about $795 million, contingent on achieving specific sales milestones for ZURZUVAE [1][5][8] Strategic and Financial Benefits - The acquisition is expected to enhance Supernus' revenue and cash flow growth while diversifying its revenue base [5][6] - ZURZUVAE, the first FDA-approved oral treatment for postpartum depression, will strengthen Supernus' portfolio in neuropsychiatric conditions [2][6] - The deal is projected to be significantly accretive in 2026, with potential annual cost synergies of up to $200 million [5][15] Revenue and Collaboration - Supernus will receive collaboration revenue equal to 50% of the net revenue recorded by Biogen for ZURZUVAE in the U.S., which amounted to $36.1 million in 2024 and $13.8 million in Q1 2025 [2][6] - The acquisition adds a fourth growth product to Supernus' portfolio, which includes Qelbree, ONAPGO, and GOCOVRI, positioning the company for significant future growth [3][6] Terms and Financing - The acquisition will be funded through existing cash on Supernus' balance sheet, with a total upfront cash payment of $8.50 per share and a CVR worth up to $3.50 per share [7][8] - The CVR is contingent on ZURZUVAE achieving specific sales milestones, including reaching $250 million, $300 million, and $375 million in annual net sales in the U.S. by specified years [8] Approvals and Timing - The transaction has been approved by the boards of both companies and is expected to close in Q3 2025, subject to customary closing conditions [9][10] - Following the tender offer, Supernus will acquire any remaining shares of Sage through a second-step merger [9] Advisors - Moelis & Company LLC is the exclusive financial advisor to Supernus, while Goldman Sachs & Co. LLC is advising Sage [11]