The company's first marketed drug, Zulresso (brexanolone), was approved by the FDA in 2019 as the first-ever FDA-approved treatment for adults with postpartum depression (PPD). SAGE markets Zurzuvae in partnership with drug giant Biogen (BIIB) . Sage and BIIB are focused on establishing Zurzuvae as a first-line therapy and the standard of care for women with PPD. Image Source: Zacks Investment Research Last month, the company reported that the phase II SURVEYOR study evaluating dalzanemdor as a potential tr ...

Sage Therapeutics (SAGE) announced that the phase II SURVEYOR study evaluating its lead neuropsychiatric candidate, dalzanemdor (SAGE-718), as a potential treatment for patients with cognition dysfunction caused by Huntington's disease (HD), met its primary endpoint. Shares of the company were however down 2.8% on Jun 11 following the announcement of the news. The SURVEYOR study compared dalzanemdor versus placebo in participants with HD for a 28-day treatment period. The three main objectives of the SURVEY ...

NEW YORK, May 23, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Sage Therapeutics, Inc. ("Sage" or the "Company") (NASDAQ: SAGE). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980. The investigation concerns whether Sage and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On April 17, 2024, Sage ...

Sage Therapeutics, Inc. (NASDAQ:SAGE) Q1 2024 Earnings Conference Call April 25, 2024 8:00 AM ET Company Participants Ashley Kaplowitz - Vice President-Investor Relations & Capital Markets Barry Greene - Chief Executive Officer & Member-Board of Directors Chris Benecchi - Chief Business Officer Laura Gault - Chief Medical Officer Kimi Iguchi - Chief Financial Officer Mike Quirk - Chief Scientific Officer Conference Call Participants Anupam Rama - JPMorgan Ritu Baral - TD Cowen Laura Chico - Wedbush Securiti ...

First Quarter 2024 Financial Results April 25, 2024 Safe Harbor Statement • The slides presented todayand the accompanying oral presentations contain forward-looking statements, which may be identified by the use of words such as "may," "might," "will," "should," "can," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "opportunity","goal", "mission", "potential," "target", or "continue," and other similar expressions. • Forward-looking statements in this presentation inc ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number: 001-36544 Sage Therapeutics, Inc. (Exact name of registrant as specified in its Charter) (State or other jurisdiction of incorpor ...

Exhibit 99.1 Sage Therapeutics Announces First Quarter 2024 Financial Results and Highlights Pipeline and Business Progress Achieved $6.2 million in ZURZUVAE™ (zuranolone) collaboration revenue during the first quarter of 2024, representing 50% of the net revenues reported by Biogen Encouraging initial demand for ZURZUVAE; More than 700 prescriptions shipped and delivered in the first quarter of 2024 Payor coverage now in place for a majority of commercially covered lives for ZURZUVAE in the treatment of wo ...

SAGE Therapeutics, Inc. (NASDAQ:SAGE) Q4 2023 Earnings Conference Call February 14, 2024 8:00 AM ET Company Participants Barry Greene - President, CEO & Director Kimi Iguchi - CFO & Treasurer Laura Gault - Chief Medical Officer Chris Benecchi - Chief Business Officer Ashley Kaplowitz - Director, IR Conference Call Participants Matt Leskowitz - Goldman Sachs Anupam Rama - J.P. Morgan Ritu Baral - TD Cowen James Condulis - Stifel Tazeen Ahmad - Bank of America Brian Abraham - RBC Capital Markets Poorna Kannan ...

2 Chris Benecchi Chief Business Officer Laura Gault Chief Medical Officer Sage Therapeutics © 2024 3 ZURZUVAE First and only oral product approved by the FDA specifically for postpartum depression (second approved product) Sage Therapeutics © 2024 The COVID-19 Pandemic had a significant effect on perinatal mental health outcomes13-15 4 Strong financial foundation to help create value for sustained growth Important Safety Information ZURZUVAE may cause serious side effects, including decreased awareness and ...

ZURZUVAE Approval and Commercialization - ZURZUVAE was approved by the FDA in August 2023 and became commercially available in the U.S. in December 2023 as the first oral treatment specifically indicated for postpartum depression (PPD)[261] - The company expects revenues from ZURZUVAE for PPD treatment to be significantly lower than if it had received regulatory approval for major depressive disorder (MDD)[262] - The company's future business prospects depend heavily on the successful commercialization of ZURZUVAE for PPD treatment in the U.S.[260] - The company may not be able to generate revenues from ZURZUVAE at expected levels or timing due to potential market acceptance issues and payer reimbursement restrictions[261] - The commercial success of ZURZUVAE depends on market acceptance, reimbursement levels, and awareness among healthcare professionals, patients, and payors[307] - Reimbursement and coverage by third-party payors are critical for patient access to ZURZUVAE, with potential restrictions and limitations varying significantly among payors[308] - Inadequate reimbursement rates for ZURZUVAE could materially affect the company's operating results, commercialization efforts, and financial condition[309] - Obtaining reimbursement approval for ZURZUVAE is a costly and time-consuming process, with downward pricing pressures from industry competition[310] - Market acceptance of ZURZUVAE depends on factors such as efficacy, safety, pricing, and the availability of alternative treatments[311] - The FDA has imposed post-marketing commitments for ZURZUVAE, including pharmacokinetic and safety studies, which could lead to delays or unexpected results[313] - ZURZUVAE and ZULRESSO are regulated as Schedule IV controlled substances, which could limit their commercialization due to additional regulatory requirements[315] - The FDA may require a REMS for ZURZUVAE, potentially increasing costs and imposing restrictions on sales, which could reduce revenue[317] - ZURZUVAE faces competition from existing therapies like SSRIs and SNRIs, as well as emerging treatments such as LPCN 1154 and BRII-296[322] - The company achieved U.S. regulatory approval for ZURZUVAE for the treatment of adults with PPD in collaboration with Biogen[330] ZULRESSO Challenges and Market Limitations - ZULRESSO, approved for PPD treatment in June 2019, faces significant barriers to revenue growth due to complex administration requirements and REMS program compliance[273] - The company's commercial operations for ZULRESSO are limited to geographies with existing active treatment sites, and the availability of ZURZUVAE may further limit ZULRESSO's revenue opportunity[274] - ZULRESSO faces significant challenges in reimbursement and coverage, with state Medicaid systems varying widely in terms of availability, terms, and timing of coverage, leading to revenue generation issues[275] - ZULRESSO's commercialization is hindered by healthcare providers' unwillingness to adopt the treatment due to product profile and reimbursement challenges, as well as competition from lower-cost antidepressants[277] - ZURZUVAE's oral treatment option for PPD may reduce healthcare settings' willingness to become infusion-ready for ZULRESSO, further limiting its market potential[277] - ZULRESSO's use is primarily focused on women with severe PPD symptoms due to its administration requirements and REMS limitations, restricting its broader market adoption[277] Regulatory and Clinical Trial Challenges - The FDA issued a complete response letter (CRL) for zuranolone's new drug application (NDA) for MDD, indicating that additional clinical trials are required for approval[265] - The FDA issued a CRL for zuranolone's NDA for MDD treatment, citing insufficient evidence of effectiveness and requiring additional clinical trials, delaying potential approval[280] - The FDA imposed post-approval obligations for ZURZUVAE, including pharmacokinetic and safety studies, which may delay or complicate its market launch[282] - The FDA rescinded Breakthrough Therapy Designation for zuranolone for MDD treatment in November 2023, impacting its development pathway and regulatory review process[284] - Positive results from non-clinical studies and clinical trials may not predict future outcomes, and interim results may not reflect final trial results[287][288] - Ongoing clinical trials for dalzanemdor (SAGE-718) and SAGE-324 may fail to meet primary endpoints, and safety issues could arise in later-stage trials[288][289] - Non-clinical animal model results may not replicate in human clinical trials, especially for central nervous system disorder treatments[290] - Delays in clinical trial commencement, enrollment, or completion could increase costs and delay regulatory approval[292][293] - Clinical trials may be suspended or terminated due to regulatory, safety, or operational challenges, including FDA holds or adverse events[294][295] - New regulatory requirements, such as the FDA's diversity action plan for Phase 3 trials, could impact trial timelines and enrollment[296] - Marketing approval outside the U.S. may require additional studies, and pricing and reimbursement approvals could face delays or restrictions[297][298] Supply Chain and Manufacturing Risks - The company relies entirely on third-party manufacturers for clinical and commercial drug supplies, exposing it to supply chain risks[300][301] - Contract manufacturers must comply with cGMPs, and FDA inspections could lead to delays or supply shortages if deficiencies are found[302][303] - Long-term supply agreements are in place for ZURZUVAE and ZULRESSO, but no redundant supply arrangements exist for SAGE-324 or dalzanemdor (SAGE-718)[305] - ZURZUVAE and ZULRESSO rely on third-party contract manufacturers for commercial production, and any delays in regulatory approvals or manufacturing issues could significantly impact product availability[306] Intellectual Property and Patent Risks - The company faces risks related to intellectual property rights, including potential challenges to patent validity and enforceability, which could impact its competitive position[365][369] - The company may be unable to prevent unauthorized disclosure or use of its technical knowledge or trade secrets, particularly in foreign countries with weaker intellectual property protections[370] - The company may face intellectual property infringement claims from third parties, which could delay product development or increase commercialization costs[374][376] - The company's patent applications may not mature into issued patents, and even if they do, the patents may not provide sufficient protection or competitive advantage[367][368] - The company may be subject to claims challenging the inventorship or ownership of its patents, potentially leading to loss of valuable intellectual property rights[378][380] - The company relies on unpatented trade secrets and technological innovation to maintain its competitive position, but these could be independently developed or disclosed by competitors[373] - The company may incur substantial costs and divert management attention in defending against intellectual property litigation, even if successful[375][376] - The company's ability to enforce its patent rights depends on its ability to detect infringement, which can be difficult and costly[370] - Patent protection could be reduced or eliminated due to noncompliance with procedural, documentary, and fee payment requirements imposed by governmental patent agencies[381] - Competitors may infringe patents, leading to expensive and time-consuming litigation, with potential risks of patents being invalidated or interpreted narrowly[382] - Interference or derivation proceedings could result in the company ceasing use of related technology or needing to license rights from the prevailing party[383] - Intellectual property litigation may lead to the disclosure of confidential information, potentially affecting the company's stock price[384] - Issued patents could be found invalid or unenforceable if challenged in court, particularly in the U.S. where counterclaims alleging invalidity are common[385] - The company may not seek patent protection in all jurisdictions due to high costs, and intellectual property rights in some countries may be less extensive than in the U.S.[386] - Competitors may use the company's technologies in jurisdictions where patent protection is not pursued, potentially leading to competition with the company's products[388] - The company is dependent on licensed intellectual property for ZULRESSO and certain product candidates, and losing these rights could impact development and commercialization[391] - Failure to comply with license agreements could result in termination, affecting the company's ability to market products covered by the licenses[392] - Intellectual property generated through U.S. government funding may be subject to federal regulations, including "march-in rights" and manufacturing preference requirements[399] - The company has obtained NCE exclusivity for brexanolone and zuranolone, and plans to seek NCE exclusivity for current and future product candidates, with a five-year period of non-patent marketing exclusivity in the U.S. for new chemical entities[401] - The Hatch-Waxman Act permits a patent restoration term of up to five years, but the company may not be granted an extension if it fails to satisfy applicable requirements, potentially leading to earlier competition[402] - The America Invents Act and recent U.S. Supreme Court rulings have increased uncertainties and costs surrounding patent prosecution and enforcement, potentially weakening the company's ability to protect its products[403][404][405] - The CREATES Act exposes the company to possible litigation and damages by competitors, which could lead to increased generic competition and lower revenues for products like ZURZUVAE and ZULRESSO[407] - Proposed U.S. legislation could limit patent exclusivity on drug products, potentially facilitating earlier entry of generic versions and adversely affecting the company's products[408][409] Financial and Operational Risks - The company has incurred significant operating losses, with a net loss of $541.5 million for the year ended December 31, 2023, and an accumulated deficit of $2.6 billion as of December 31, 2023[432] - The company received $75.0 million in milestone payments for the first commercial sale of ZURZUVAE in the U.S. in Q4 2023[432] - The company expects operating expenses to decrease in 2024 compared to 2023 due to a strategic corporate reorganization and pipeline reprioritization[433] - The company's cash, cash equivalents, and marketable securities totaled $753.2 million as of December 31, 2023[432] - The company anticipates continued significant operating losses as it commercializes ZURZUVAE and advances other product candidates[434] - The company's ability to generate revenue depends on successful commercialization of ZURZUVAE and other products, as well as market acceptance and reimbursement[435] - The company may need to raise additional capital in the future to fund operations, which could dilute existing stockholders' ownership[437] - Cash, cash equivalents, and marketable securities totaled $753.2 million as of December 31, 2023[439][594] - The company anticipates existing cash and funding will support operations into 2026, but no milestone payments from collaborations are expected for the remainder of 2024[439] - The company may need to seek additional funds sooner than planned through equity or debt financings, collaborations, or other strategic arrangements[439] - Failure to obtain capital could force the company to delay, limit, or terminate product development efforts or other operations[443] - The company's stock price is volatile and may fluctuate due to factors such as commercialization efforts, clinical trial results, regulatory activities, and macroeconomic conditions[445] - The company has broad discretion in the use of its cash and proceeds from potential future offerings, which may not yield significant returns for stockholders[446] - Anti-takeover provisions in the company's charter documents and Delaware law could make acquisitions or management changes more difficult[447] - Future sales of common stock, including shares no longer subject to lockup periods, could significantly reduce the market price of the company's stock[448] - The company has exposure to fluctuations in foreign exchange rates due to contracts with vendors in foreign countries and subsidiaries in Europe, Canada, and Bermuda[595] - Inflation increased the company's cost of labor and clinical trial costs, but did not have a material effect on results of operations for the year ended December 31, 2023[597] Regulatory and Legal Compliance Risks - The company may face challenges in complying with the Medicaid Drug Rebate Program and other governmental pricing programs, which could impact financial results[342] - Compliance with Medicaid Drug Rebate Program and other federal/state drug pricing programs could increase costs, with potential civil monetary penalties of up to $100,000 per false item submitted[344] - Potential termination of Medicaid drug rebate agreement or 340B program participation could result in no federal payments for covered outpatient drugs under Medicaid or Medicare Part B[344] - Federal False Claims Act imposes penalties including mandatory treble damages and significant per-claim penalties for false or fraudulent claims[347] - GDPR compliance for EU clinical trials imposes strict data transfer rules and fines up to €20 million or 4% of global annual turnover for violations[353] - California Consumer Privacy Act (CCPA) and California Privacy Rights Act (CPRA) impose significant penalties, including civil fines up to $7,500 per violation and private right of action for data breaches[354] - EU-U.S. Data Privacy Framework adopted in July 2023, but challenges from privacy advocacy groups may impact data transfer mechanisms[358] - Off-label promotion of products like ZURZUVAE or ZULRESSO could result in significant liability, including civil and criminal fines under the False Claims Act[359] - Expansion into foreign markets may face regulatory burdens, price controls, and reimbursement challenges, impacting profitability[360] - Pricing of prescription drugs in foreign markets is subject to governmental control, potentially leading to delays in pricing negotiations and reduced profitability if reimbursement is limited or pricing is unsatisfactory[361][362] - Brexit may continue to adversely affect regulatory conditions in the EU and the UK, potentially impairing the company's ability to transact business in these regions[363] Competition and Market Risks - The company faces competition from Marinus Pharmaceuticals, Inc., which received FDA approval for ganaxolone to treat seizures associated with CDKL5 deficiency disorder[325] - SAGE-324, a novel GABAA receptor positive allosteric modulator, is in Phase 2 development for essential tremor[326] - Dalzanemdor (SAGE-718) is being explored for cognition-related disorders associated with NMDA receptor dysfunction, including Huntington's, Parkinson's, and Alzheimer's diseases[327] - The company may face delays or disputes in collaborations with Biogen and Shionogi, potentially impacting development and commercialization efforts[328] - The company's future success depends on its ability to attract, retain, and motivate qualified personnel[338] - The company maintains product liability insurance coverage with a $20.0 million annual aggregate coverage limit[341] - The company relies on third parties, including CROs, to conduct clinical trials for its product candidates[336] - The company's drug development programs and commercialization efforts require substantial additional cash to fund expenses[329] Healthcare Policy and Pricing Risks - The ACA and IRA have introduced measures such as Medicare price negotiations, inflation rebates, and coverage gap discounts, which could negatively impact the company's revenue and pricing strategies[412][417][418] - Medicare sequester reductions, currently at 2%, will increase to 4% by fiscal year 2031, potentially affecting the company's product pricing and reimbursement[413] - The IRA requires Medicare price negotiations for high-cost drugs starting in 2026, with biologics eligible for negotiation 11 years post-approval, which could impact the company's future revenue and development decisions[418][419] - The IRA imposes civil monetary penalties and excise taxes on drug manufacturers for non-compliance with price regulations, including a cap on Medicare out-of-pocket drug costs at $2,000 annually starting in 2025[420] - The IRA may result in reduced reimbursement for products, potentially impacting the company's business, operations, and financial condition[422] - State-level legislation and regulations are increasingly targeting pharmaceutical pricing, including price transparency measures and restrictions on product access[423]