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Sage Therapeutics(SAGE) - 2025 Q1 - Quarterly Report
SAGESage Therapeutics(SAGE)2025-04-29 20:18
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Financial Position - As of March 31, 2025, the company's total cash equivalents amounted to 42.139million,adecreasefrom42.139 million, a decrease from 80.239 million as of December 31, 2024[80][81]. - The total marketable securities held by the company as of March 31, 2025, were valued at 378.630million,downfrom378.630 million, down from 423.397 million as of December 31, 2024[80][83]. - The company held cash, cash equivalents, and marketable securities totaling 423.9millionasofMarch31,2025[267].−Thecompanydoesnotexpectsignificantimpactfromfluctuationsininterestratesonitsfinancialconditionduetotheshort−termnatureofitscashandmarketablesecurities[267].−Thecompanyhasexposuretoforeigncurrencyexchangeratefluctuationsbutconsidersthisexposuretobeimmaterial[268].−Inflationhasnotmateriallyaffectedthecompany′sresultsofoperationsduringthethreemonthsendedMarch31,2025,and2024[270].MarketableSecuritiesandInvestments−Thecompanyreportedunrealizedlossesof423.9 million as of March 31, 2025[267]. - The company does not expect significant impact from fluctuations in interest rates on its financial condition due to the short-term nature of its cash and marketable securities[267]. - The company has exposure to foreign currency exchange rate fluctuations but considers this exposure to be immaterial[268]. - Inflation has not materially affected the company's results of operations during the three months ended March 31, 2025, and 2024[270]. Marketable Securities and Investments - The company reported unrealized losses of 82,000 on its marketable securities as of March 31, 2025, attributed to interest rate increases[84]. - The fair value of U.S. corporate bonds held by the company was 253.414millionasofMarch31,2025,comparedto253.414 million as of March 31, 2025, compared to 269.013 million as of December 31, 2024[82][83]. - The company had accrued interest receivable of 2.7millionrelatedtoavailable−for−salesecuritiesasofMarch31,2025[83].−Allmarketablesecuritiesheldbythecompanyhadremainingcontractualmaturitiesofoneyearorless,exceptforU.S.corporatebondsandinternationalcorporatebondswithafairvalueof2.7 million related to available-for-sale securities as of March 31, 2025[83]. - All marketable securities held by the company had remaining contractual maturities of one year or less, except for U.S. corporate bonds and international corporate bonds with a fair value of 40.0 million and maturities of one to two years as of March 31, 2025[85]. - The company did not experience any impairments of assets measured and carried at fair value during the three months ended March 31, 2025[87]. - The company performed validation procedures on fair value measurements and did not adjust any provided by pricing services as of March 31, 2025[79]. Legal and Regulatory Matters - The Company is involved in a federal securities class action lawsuit alleging violations of U.S. securities laws, with unspecified damages sought for stock purchases made between April 12, 2021, and July 23, 2024[89]. - The Company received a subpoena from the SEC regarding zuranolone for MDD treatment, and is cooperating with the investigation[90]. - The Company is unable to predict the outcome of ongoing legal proceedings or reasonably estimate potential losses[93]. Collaborations and Revenue - The Company entered a strategic collaboration with Shionogi for zuranolone, with an upfront payment of 90millionandpotentialmilestonepaymentsofupto90 million and potential milestone payments of up to 485 million[95]. - The Company achieved a 75millionmilestoneforthefirstcommercialsaleofZURZUVAEfortreatingwomenwithPPDintheU.S.inQ42023[106].−TheBiogenCollaborationAgreementallowsforpotentialmilestonepaymentsofupto75 million milestone for the first commercial sale of ZURZUVAE for treating women with PPD in the U.S. in Q4 2023[106]. - The Biogen Collaboration Agreement allows for potential milestone payments of up to 1.6 billion, but the Company will not receive 150millionforMDDduetohalteddevelopment[106].−TheCompanyiseligiblefortieredroyaltiesonnetsalesofSAGE−217productsintheBiogenTerritory,rangingfromhighteenstolowtwentiespercentagerates[108].−TheBiogenCollaborationAgreementwillcontinueuntilroyaltytermsexpireintheBiogenTerritory,withBiogenresponsiblefordevelopmentandcommercializationcosts[112].−TheCompanymaintainsexclusiverightstodevelopandcommercializezuranoloneoutsidetheShionogiTerritory[95].−InQ42023,theCompanyrecognized150 million for MDD due to halted development[106]. - The Company is eligible for tiered royalties on net sales of SAGE-217 products in the Biogen Territory, ranging from high teens to low twenties percentage rates[108]. - The Biogen Collaboration Agreement will continue until royalty terms expire in the Biogen Territory, with Biogen responsible for development and commercialization costs[112]. - The Company maintains exclusive rights to develop and commercialize zuranolone outside the Shionogi Territory[95]. - In Q4 2023, the Company recognized 75 million in license and milestone revenue related to the first commercial sale of ZURZUVAE for the treatment of women with PPD in the U.S.[119]. - For the three months ended March 31, 2025, collaboration revenue from Biogen was 13.8million,comparedto13.8 million, compared to 6.2 million for the same period in 2024[123]. - The Company recorded a collaboration receivable of 10.7millionasofMarch31,2025,representingnetreimbursementamountsdue[123].Stock−BasedCompensationandEquity−TheCompanyhasanATMSalesAgreementallowingforthesaleofupto10.7 million as of March 31, 2025, representing net reimbursement amounts due[123]. Stock-Based Compensation and Equity - The Company has an ATM Sales Agreement allowing for the sale of up to 250 million in common stock, with no shares sold under this agreement as of March 31, 2025[131][136]. - The 2024 Equity Incentive Plan was approved, allowing for the grant of up to 16,502,166 shares of common stock[138]. - As of March 31, 2025, the total number of shares underlying outstanding awards under the 2024 Plan, the 2014 Plan, and the 2016 Plan was 8,782,994, with 6,214,108 shares available for future issuance under the 2024 Plan[142]. - The Company granted 1,493,452 time-based restricted stock units during the three months ended March 31, 2025, compared to 857,084 in the same period of 2024[147]. - The total unrecognized stock-based compensation expense related to time-based restricted stock units was 15.8million,expectedtoberecognizedoveraremainingweightedaveragevestingperiodof3.57years[148].−TheCompanyrecordedstock−basedcompensationexpenseof15.8 million, expected to be recognized over a remaining weighted average vesting period of 3.57 years[148]. - The Company recorded stock-based compensation expense of 6.9 million for the three months ended March 31, 2025, down from 13.7millioninthesameperiodof2024[161].−AsofMarch31,2025,thetotalunrecognizedstock−basedcompensationexpenserelatedtoperformancerestrictedstockunitswas13.7 million in the same period of 2024[161]. - As of March 31, 2025, the total unrecognized stock-based compensation expense related to performance restricted stock units was 34.4 million[154]. - The Company accepted for exchange eligible options to purchase a total of 3,079,608 shares, granting replacement options for a total of 1,483,113 shares with an exercise price of 22.20pershare[144].−TheCompanyexpectstoincuratotalof22.20 per share[144]. - The Company expects to incur a total of 1.7 million of additional stock-based compensation expense as a result of the Option Exchange, to be recognized over the 18-month vesting period[145]. Financial Performance - The net loss for the three months ended March 31, 2025, was 62.2million,resultinginabasicanddilutednetlosspershareof62.2 million, resulting in a basic and diluted net loss per share of 1.01, compared to a net loss of 108.5millionandalosspershareof108.5 million and a loss per share of 1.80 in 2024[163]. - Revenues for the three months ended March 31, 2025, were 14,063,000,a77.514,063,000, a 77.5% increase from 7,902,000 in the same period of 2024[172]. - Net loss for the three months ended March 31, 2025, was (62,214,000),asignificantimprovementcomparedto(62,214,000), a significant improvement compared to (108,483,000) in the same period of 2024, reflecting a reduction of 42.7%[172]. - Program expenses for zuranolone (ZURZUVAE) increased to 12,010,000inQ12025from12,010,000 in Q1 2025 from 5,257,000 in Q1 2024, representing a 128.5% increase[172]. - Non-program expenses decreased to 19,258,000inQ12025from19,258,000 in Q1 2025 from 22,131,000 in Q1 2024, indicating a reduction of 12.6%[172]. - Total restructuring charges incurred through March 31, 2025, amounted to 32.9million,withnorelatedexpensesrecordedduringthethreemonthsendedMarch31,2025[165].−Totalchargesrelatedtothe2024RestructuringincurredthroughMarch31,2025,are32.9 million, with no related expenses recorded during the three months ended March 31, 2025[165]. - Total charges related to the 2024 Restructuring incurred through March 31, 2025, are 22.8 million, which is the total expected amount to be incurred[167].