ZURZUVAE

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Biogen(BIIB) - 2025 Q2 - Earnings Call Presentation
2025-07-31 12:30
Financial Performance - Total revenue increased by 7% year-over-year to $265 billion[53] - Launch products generated $252 million in revenue, a 26% increase quarter-over-quarter and a 91% increase year-over-year[53] - Non-GAAP diluted EPS increased by 4% year-over-year to $547[53] - The company generated $134 million of free cash flow, which includes a $745 million impact from Q2 2025 tax payments[53] - The company expects full-year 2025 Non-GAAP diluted EPS between $1550 and $1600, up from the previous guidance of $1450 to $1550[53] - The company expects full-year 2025 total revenue to be approximately flat at constant currency versus FY 2024, an increase from a mid-single-digit decline previously[53] Product Performance - SKYCLARYS worldwide sales reached $130 million in Q2, up 30% year-over-year and 5% quarter-over-quarter[47] - SKYCLARYS U S sales were $78 million, up 3% year-over-year and 13% quarter-over-quarter[47] - ZURZUVAE U S sales were $46 million in Q2, up 213% year-over-year and 68% quarter-over-quarter[48] - LEQEMBI worldwide sales were $160 million in Q2, excluding $35 million in stocking in China; U S sales increased 20% quarter-over-quarter to $63 million[49] Pipeline and Development - Phase 3 studies were initiated for felzartamab in IgAN and PMN, and for SKYCLARYS in pediatric FA[18] - Positive Phase 1b results for salanersen support moving to registrational status for SMA, with a Phase 3 study expected to start by early 2026[18,32] - New analyses of dapirolizumab pegol Phase 3 data in SLE show improvement in fatigue and reduction in disease activity[18]
Supernus Pharmaceuticals Announces Expiration of Hart-Scott-Rodino Waiting Period for Sage Therapeutics, Inc. Tender Offer
Globenewswireยท 2025-07-28 12:25
Core Viewpoint - Supernus Pharmaceuticals has announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act for its proposed acquisition of Sage Therapeutics, indicating progress towards completing the merger [1][3]. Acquisition Details - Supernus and Sage entered into a Merger Agreement on June 13, 2025, with the necessary premerger notifications filed with regulatory authorities shortly thereafter [2]. - The Offer to Purchase for Sage's outstanding shares is set at $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 [4]. Contingent Value Rights (CVR) - The CVR includes milestone payments contingent on the commercial success of the product ZURZUVAE, with payments structured as follows: - $0.50 per CVR upon the first commercial sale in Japan after regulatory approval by June 30, 2026 [5]. - $1.00 per CVR if net sales of ZURZUVAE reach $250 million in the U.S. by December 31, 2027 [6]. - $1.00 per CVR if net sales reach $300 million in the U.S. by December 31, 2028 [7]. - $1.00 per CVR if net sales reach $375 million in the U.S. by December 31, 2030 [8]. - The total maximum payout for each CVR is capped at $3.50, with no guarantee that any payments will be made [9][10]. Merger Completion - Upon completion of the Offer, Supernus plans to merge its wholly owned subsidiary with Sage, resulting in Sage becoming a wholly owned subsidiary of Supernus [11]. - Shares not purchased in the Offer will be converted into the right to receive the Offer Price, and Sage's shares will be delisted from NASDAQ [11]. Advisory Information - Moelis & Company LLC is the exclusive financial advisor for Supernus, while Goldman Sachs & Co. LLC serves as the exclusive financial advisor for Sage [12].
Supernus Pharmaceuticals (SUPN) Earnings Call Presentation
2025-06-18 07:03
Acquisition Overview - Supernus Pharmaceuticals is acquiring Sage Therapeutics, Inc for an offer price of $8.50 per share in cash at closing[9] - A contingent value right (CVR) of up to $3.50 per share is payable based on ZURZUVAE U S net sales milestones and commercialization in Japan[9] - $1.00 per share if ZURZUVAE U S net sales reach $250 million or more by YE 2027[9] - $1.00 per share if ZURZUVAE U S net sales reach $300 million or more by YE 2028[9] - $1.00 per share if ZURZUVAE U S net sales reach $375 million or more by YE 2030[9] - $0.50 per share at commercialization in Japan by June 30, 2026[9] - The equity value at closing is $561 million, with a total potential value of up to approximately $795 million[9] - The acquisition is expected to close in Q3 2025[9] Financial Impact and Synergies - The acquisition is expected to be significantly accretive to adjusted operating income (non-GAAP), operating income, and EPS in 2026[9, 11] - Strong fit with existing Supernus infrastructure yields up to $200 million in potential synergies on an annual basis[9, 11] - The transaction will be financed through cash on the balance sheet[9] ZURZUVAE and Market Opportunity - ZURZUVAE is the first and only oral treatment specifically indicated for the treatment of women with PPD (Postpartum Depression)[12] - Approximately 500,000 new women experience symptoms of PPD each year, with approximately 175,000 diagnosed and approximately 100,000 treated[19] - ZURZUVAE demonstrated statistically significant improvement in depressive symptoms vs placebo at day 15 following a 14-day treatment course in clinical trials[12] Revenue and Growth - ZURZUVAE U S collaboration revenue has shown growth since launch, with Q1 2025 reaching $13.8 million[22] - This represents 123% year-over-year growth and 21% quarter-over-quarter growth[22]
Sage Therapeutics(SAGE) - 2025 Q1 - Earnings Call Presentation
2025-04-30 00:14
Commercial Performance of ZURZUVAE - In Q1 2025, over 3,000 shipments of ZURZUVAE were made to women with PPD[13] - Approximately 80% of ZURZUVAE prescriptions in Q1 2025 were written by OBGYNs[15] - More than 70% of women prescribed ZURZUVAE received it as their first new treatment for PPD[17] - The company is strategically investing in the commercialization of ZURZUVAE in the PPD market[12] Financial Results (Q1 2025) - Total revenue was $14.1 million, compared to $7.9 million in Q1 2024[23] - Collaboration revenue was $13.8 million, compared to $6.2 million in Q1 2024[23] - Net loss was ($62.2 million), compared to ($108.5 million) in Q1 2024[23] - Research and Development (R&D) expenses were $22.8 million, compared to $71.7 million in Q1 2024[23] - Cash and marketable securities totaled $0.4 billion, compared to $0.7 billion in Q1 2024[23] Pipeline and Strategic Focus - The company is focused on developing novel programs in diseases with high unmet needs in Neurodevelopmental Disorders & Neuropsychiatry[12] - The company is evaluating potential indications for SAGE-324, including seizures in developmental and epileptic encephalopathies (DEEs), with an update expected in mid-2025[24]