Sage Therapeutics Announces Third Quarter 2024 Financial Results and Highlights Pipeline and Business Updates
Sage Therapeutics reported Q3 2024 financial results, highlighting $11 million in ZURZUVAE collaboration revenue, a 49% increase from Q2. The company announced it will not pursue zuranolone development for major depressive disorder in the US, focusing instead on postpartum depression treatment. Key metrics include approximately 2,000 prescriptions shipped in Q3 (40% increase from Q2), with over 90% commercial and Medicaid coverage. Cash position stood at $569 million as of September 30. The company plans to discontinue ZULRESSO by December 31, 2024, and expects current funds to support operations into 2026.
Sage Therapeutics ha riportato i risultati finanziari del terzo trimestre 2024, evidenziando 11 milioni di dollari in entrate dalla collaborazione su ZURZUVAE, un incremento del 49% rispetto al secondo trimestre. L'azienda ha annunciato che non proseguirà con lo sviluppo di zuranolone per il disturbo depressivo maggiore negli Stati Uniti, concentrandosi invece sul trattamento della depressione postpartum. Metrica chiave include circa 2.000 prescrizioni spedite nel terzo trimestre (aumento del 40% rispetto al secondo trimestre), con oltre il 90% di copertura commerciale e Medicaid. La posizione di cassa si attesta a 569 milioni di dollari al 30 settembre. L'azienda prevede di interrompere ZULRESSO entro il 31 dicembre 2024 e si aspetta che i fondi attuali possano sostenere le operazioni fino al 2026.
Sage Therapeutics informó sobre los resultados financieros del tercer trimestre de 2024, destacando $11 millones en ingresos de colaboración de ZURZUVAE, un aumento del 49% en comparación con el segundo trimestre. La empresa anunció que no seguirá adelante con el desarrollo de zuranolona para el trastorno depresivo mayor en EE. UU., enfocándose en cambio en el tratamiento de la depresión posparto. Métricas clave incluyen aproximadamente 2,000 recetas enviadas en el tercer trimestre (un aumento del 40% respecto al segundo trimestre), con más del 90% de cobertura comercial y Medicaid. La posición de efectivo era de $569 millones al 30 de septiembre. La empresa planea discontinuar ZULRESSO para el 31 de diciembre de 2024 y espera que los fondos actuales sean suficientes para operar hasta 2026.
세이지 테라퓨틱스는 2024년 3분기 재무 결과를 보고하며, 주르주바에와의 협력에서 1천1백만 달러의 수익을 강조했고, 이는 2분기 대비 49% 증가한 수치입니다. 이 회사는 미국에서 주요 우울 장애 치료를 위한 주라놀론 개발을 중단하고, 대신 산후 우울증 치료에 집중할 것이라고 발표했습니다. 핵심 지표에는 3분기 동안 약 2천 건의 처방전이 발송되었으며(2분기 대비 40% 증가), 90% 이상의 상업적 및 메디케이드 보장이 포함됩니다. 현금 보유액은 9월 30일 기준으로 5억 6900만 달러에 달했습니다. 회사는 2024년 12월 31일까지 ZULRESSO를 중단할 계획이며, 현재 자금이 2026년까지 운영을 지원할 것으로 예상하고 있습니다.
Sage Therapeutics a publié les résultats financiers du troisième trimestre 2024, mettant en avant 11 millions de dollars de revenus de collaboration provenant de ZURZUVAE, soit une augmentation de 49 % par rapport au deuxième trimestre. La société a annoncé qu'elle ne poursuivrait pas le développement de zuranolone pour le trouble dépressif majeur aux États-Unis, se concentrant plutôt sur le traitement de la dépression post-partum. Mesures clés incluent environ 2.000 prescriptions expédiées au troisième trimestre (augmentation de 40 % par rapport au deuxième trimestre), avec plus de 90 % de couverture commerciale et Medicaid. La position de trésorerie s'élevait à 569 millions de dollars au 30 septembre. La société prévoit de cesser ZULRESSO d'ici le 31 décembre 2024 et s'attend à ce que les fonds actuels puissent soutenir les opérations jusqu'en 2026.
Sage Therapeutics berichtete über die finanziellen Ergebnisse des dritten Quartals 2024 und hob Einnahmen aus der Zusammenarbeit mit ZURZUVAE in Höhe von 11 Millionen Dollar hervor, was einem Anstieg von 49 % im Vergleich zum zweiten Quartal entspricht. Das Unternehmen gab bekannt, dass es die Entwicklung von Zuranolon für die schwere depressive Störung in den USA nicht weiterverfolgen wird, sondern sich stattdessen auf die Behandlung von postpartalen Depressionen konzentriert. Schlüsseldaten umfassen etwa 2.000 versendete Verschreibungen im dritten Quartal (40 % mehr als im zweiten Quartal), mit einer Abdeckung von über 90 % durch kommerzielle und Medicaid-Versicherungen. Die Liquiditätsposition betrug zum 30. September 569 Millionen Dollar. Das Unternehmen plant, ZULRESSO bis zum 31. Dezember 2024 einzustellen, und erwartet, dass die aktuellen Mittel den Betrieb bis 2026 unterstützen können.
- ZURZUVAE revenue grew 49% quarter-over-quarter to $11 million
- Prescription shipments increased 40% to 2,000 in Q3
- Over 90% commercial and Medicaid coverage achieved
- Strong cash position of $569 million
- Operating expenses expected to decrease in 2025
- Net loss of $93.6 million in Q3 2024
- Discontinuation of ZULRESSO product by end of 2024
- Termination of zuranolone development for MDD in US
- Failed Phase 2 LIGHTWAVE Study for dalzanemdor in Alzheimer's
- ZULRESSO revenue declined to $0.8M from $2.7M year-over-year
Insights
The Q3 results show mixed signals for Sage Therapeutics. While
Key financial metrics include
ZURZUVAE's market penetration shows encouraging early signs with approximately 2,000 prescriptions in Q3, a
However, the pipeline setbacks in Alzheimer's and essential tremor create significant dependency on ZURZUVAE's success in PPD. The strategic focus on PPD reduces diversification but may improve execution efficiency. The HD trial results expected later this year could provide a important secondary growth driver.
Achieved
Sage and Biogen will not pursue further development of zuranolone in major depressive disorder (MDD) in the
Topline data from the DIMENSION Study in Huntington’s Disease (HD) expected late 2024
Cash, cash equivalents and marketable securities of
“We are committed to harnessing the full potential of ZURZUVAE as a transformative treatment for women with postpartum depression. Our encouraging third quarter results, highlighted by continued growth in revenue and shipments, brings us one step closer to our goal of establishing ZURZUVAE as the standard of care to help more women suffering from this debilitating condition,” said Barry Greene. “Looking forward, we believe that our strategic decisions, including the recent reorganization, will best-position Sage to foster long-term growth and support our mission of better brain health for patients.”
Third Quarter 2024 Portfolio Updates
ZURZUVAE
Sage and its collaborator, Biogen, are focused on the goal of establishing ZURZUVAE as the first line therapy and standard of care for women with postpartum depression (PPD). As of the third quarter ended September 30, 2024, the following results had been achieved:
-
in collaboration revenue from ZURZUVAE in the third quarter of 2024, representing a$11 million 49% increase from the second quarter. Collaboration revenues represent50% of the net revenues recorded when Biogen ships ZURZUVAE to the distributors. -
Approximately 2,000 prescriptions were shipped and delivered in the third quarter, representing an approximately
40% increase from the second quarter. - Sage’s expanded sales force is in the field as of the start of the fourth quarter.
Related to payor coverage, as of September 30, 2024:
-
Over
90% of commercial and Medicaid lives are covered by payor policies in PPD, with the majority having no step therapy or complex prior authorizations. - All three national PBMs have developed favorable coverage policies for ZURZUVAE in the treatment of women with PPD.
In terms of prescriber trends:
-
ZURZUVAE is being prescribed across a breadth of HCPs who treat PPD. OBGYNs account for
70% of all prescribers. - Prescribers and repeat writers continue to increase quarter over quarter with most new prescribers initiating after an interaction with a sales representative.
- Of those HCPs prescribing ZURZUVAE, the majority are using ZURZUVAE as a first-line PPD treatment.
-
Company data suggests
90% aided brand awareness for ZURZUVAE among OBGYNs and psychiatrists.
Zuranolone Business Update
In August 2023, the FDA issued a Complete Response Letter for the New Drug Application for zuranolone in the treatment of adults with MDD. Sage and Biogen will not pursue further development of zuranolone as a treatment for MDD in the
ZULRESSO
Sage plans to sunset ZULRESSO® (brexanolone) as a part of its strategic shift to further focus on the commercialization of ZURZUVAE for the treatment of women with PPD. ZULRESSO will be commercially available until December 31, 2024.
Pipeline
Dalzanemdor (SAGE-718)
Sage recently announced results from the Phase 2 LIGHTWAVE Study in the treatment of mild cognitive impairment and mild dementia in Alzheimer’s Disease (AD). The LIGHTWAVE Study did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Test at Day 84, the primary endpoint. Dalzanemdor was generally well-tolerated and no new safety signals were observed. The majority of treatment emergent adverse events were mild to moderate in severity. Based on these data, the Company does not plan further clinical development of dalzanemdor in AD.
Ongoing studies in the dalzanemdor clinical program include:
- DIMENSION (CIH-201) Study: The DIMENSION Study is a double-blind, placebo-controlled Phase 2 study in participants with cognitive impairment associated with HD. The study is designed to evaluate the efficacy and safety of once-daily dalzanemdor dosed over three months.
- PURVIEW (CIH-301) Study: The PURVIEW Study is an open-label Phase 3 safety study designed to evaluate the long-term safety and tolerability of dalzanemdor in participants with HD.
The Company expects to report topline data from the Phase 2 DIMENSION Study of dalzanemdor in cognitive impairment associated with HD later this year.
SAGE-324
In September, Sage announced that Biogen terminated its rights under the collaboration and license agreement with Sage specific to the SAGE-324 program. The companies previously announced negative results from the Phase 2 KINETIC 2 Study of investigational SAGE-324 for the chronic treatment of essential tremor (ET) and discontinued further clinical development of SAGE-324 in ET. Under the terms of the collaboration and license agreement, the termination will be effective on February 17, 2025, and Sage will resume full ownership of SAGE-324 at that time. Sage is continuing to evaluate other potential indications, if any, for SAGE-324.
Recent Period Business Update
In October, Sage announced a strategic reorganization of its business operations to support the ongoing launch of ZURZUVAE in PPD and focus pipeline development efforts ahead of the clinical study readout for dalzanemdor in HD expected later this year. The reorganization is intended to enable Sage to strengthen its balance sheet, extend cash runway, and position the company for long-term growth potential and is planned to be substantially completed by the end of the fourth quarter of 2024.
FINANCIAL RESULTS FOR THE THIRD QUARTER 2024
-
Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2024 were
compared to$569 million at June 30, 2024.$647 million
-
Revenue: Collaboration revenue from sales of ZURZUVAE was
in the third quarter of 2024, representing a$11 million 49% increase compared to the second quarter of 2024. Reported collaboration revenue is50% of the net revenues Biogen records for ZURZUVAE in theU.S. Net revenue from sales of ZULRESSO was in the third quarter of 2024, compared to$0.8 million in the same period of 2023.$2.7 million
-
Cost of Revenues: Cost of revenues were
in the third quarter of 2024 compared to$5.3 million for the same period in 2023. The third quarter 2024 expenses included$0.9 million of one-time excess inventory write-offs and intangible asset impairment costs related to the planned discontinuation of ZULRESSO commercial availability.$3.6 million
-
R&D Expenses: Research and development expenses were
, including$54.6 million of non-cash stock-based compensation expense, in the third quarter of 2024 compared to$5.5 million , including$101.9 million of non-cash stock-based compensation expense, for the same period in 2023. The decrease in R&D expenses as compared to the same period in 2023 was primarily related to the 2023 reorganization cost savings measures, including reduced headcount, budgeted expenditures and reprioritization of early-stage pipeline programs. The reimbursement from Biogen to Sage for R&D expenses pursuant to the Sage/Biogen Collaboration and License Agreement was$6.9 million in the third quarter of 2024 compared to$5.4 million in the same period of 2023.$28.2 million
-
SG&A Expenses: Selling, general and administrative expenses were
, including$53.2 million of non-cash stock-based compensation expense, in the third quarter of 2024, compared to$8.7 million , including$78.1 million of non-cash stock-based compensation expense, for the same period in 2023. The decrease in SG&A expenses as compared to the same period in 2023 was primarily related to stock-based compensation expense related to one-time vesting events in the third quarter of 2023 and the 2023 reorganization cost savings measures, including reduced headcount and budgeted expenditures. The reimbursement from Sage to Biogen for SG&A expenses pursuant to the Sage/Biogen Collaboration and License Agreement was$21.0 million in the third quarter of 2024 compared to$2.4 million in the same period of 2023.$5.8 million
-
Net Loss: Net loss was
for the third quarter of 2024 compared to$93.6 million for the same period in 2023.$201.6 million
FINANCIAL GUIDANCE
- Based upon the Company's current operating plan, Sage anticipates that its existing cash, cash equivalents and marketable securities as of September 30, 2024, anticipated funding from ongoing collaborations and estimated revenues, excluding any potential savings resulting from its October 2024 reorganization, will support its operations into 2026. The Company plans to update cash runway guidance in the near future.
- The Company does not anticipate receipt of any milestone payments from collaborations in the remainder of 2024.
- The Company anticipates operating expenses will decrease in 2025 relative to 2024.
- With the uptake of ZURZUVAE as an oral treatment for women with PPD, the Company anticipates ZULRESSO use will continue to decrease and has decided to no longer make ZULRESSO commercially available as of December 31, 2024.
Conference Call Information
Sage will host a conference call and webcast today, October 29, 2024, at 4:30 p.m. ET to review its third quarter 2024 financial results and discuss recent corporate updates. The live webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available on Sage's website following the completion of the event and will be archived for up to 30 days.
About Sage Therapeutics
Sage Therapeutics (Nasdaq: SAGE) is a biopharmaceutical company committed to our mission of pioneering solutions to deliver life-changing brain health medicines, so every person can thrive. Sage developed the only two FDA-approved treatments indicated for postpartum depression and is advancing a robust pipeline to target unmet needs in brain health. Sage was founded in 2010 and is headquartered in
Forward-Looking Statements
Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation our statements regarding: our plans, expectations and goals for commercialization of ZURZUVAE as a treatment for women with PPD, including our goal to establish ZURZUVAE as the first line therapy and standard of care in this indication; our beliefs that our strategic decisions, including implementation of the October 2024 reorganization, will reduce our operating expenses, foster long-term growth and support our mission; our belief in the potential for ZURZUVAE and that ZURZUVAE will be successful as a transformative treatment in helping women with PPD; anticipated timelines for completion of enrollment in clinical trials and reporting of results with respect to certain of our other programs, including the expected timing of readout of the DIMENSION Study of dalzanemdor in HD; our plans to not pursue further development of zuranolone as a treatment for MDD and discontinue commercial availability of ZULRESSO as of December 31, 2024, and our strategic shift to further focus on commercialization of ZURZUVAE for the treatment of women with PPD; our expectations regarding expenses and our cash runway, including our plans to update our cash runway guidance in the near future; our plans to evaluate next steps, if any, for the SAGE-324 program; our expectations related to the October 2024 reorganization, including timing, cost savings, and our goals to position the company for long-term growth and focus pipeline development efforts; our belief in the potential profile and benefit of our product candidates, potential indications for our product candidates, the potential for success of our programs, and the opportunity to help patients in various indications; our belief as to the key catalysts for our business and potential value creation; and the mission and goals for our business. These statements constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: we may not realize cost savings from the October 2024 reorganization at the levels we expect, and as a result, the reorganization may not strengthen our balance sheet, foster long-term growth, or enable us to extend our cash runway; our launch and commercialization efforts in the
Financial Tables
Sage Therapeutics, Inc. and Subsidiaries | |||||
Condensed Consolidated Balance Sheets | |||||
(in thousands) | |||||
(unaudited) | |||||
September 30, 2024 | December 31, 2023 | ||||
Cash, cash equivalents and marketable securities | $ |
569,155 |
$ |
753,184 |
|
Total assets |
|
622,432 |
|
882,277 |
|
Total liabilities |
|
70,597 |
|
82,747 |
|
Total stockholders' equity |
|
551,835 |
|
799,530 |
|
Sage Therapeutics, Inc. and Subsidiaries | |||||||||||||||
Condensed Consolidated Statements of Operations | |||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||
(unaudited) | |||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Product revenue, net | $ |
843 |
|
$ |
2,716 |
|
$ |
3,132 |
|
$ |
8,469 |
|
|||
Collaboration revenue - related party |
|
11,028 |
|
|
- |
|
|
24,661 |
|
|
- |
|
|||
Other collaboration revenue |
|
- |
|
|
- |
|
|
634 |
|
|
14 |
|
|||
Total revenues |
|
11,871 |
|
|
2,716 |
|
|
28,427 |
|
|
8,483 |
|
|||
Operating costs and expenses: | |||||||||||||||
Cost of revenues |
|
5,278 |
|
|
905 |
|
|
7,955 |
|
|
1,339 |
|
|||
Research and development |
|
54,576 |
|
|
101,919 |
|
|
188,873 |
|
|
291,905 |
|
|||
Selling, general and administrative |
|
53,219 |
|
|
78,142 |
|
|
161,775 |
|
|
219,415 |
|
|||
Restructuring |
|
- |
|
|
33,599 |
|
|
- |
|
|
33,599 |
|
|||
Total operating costs and expenses |
|
113,073 |
|
|
214,565 |
|
|
358,603 |
|
|
546,258 |
|
|||
Loss from operations |
|
(101,202 |
) |
|
(211,849 |
) |
|
(330,176 |
) |
|
(537,775 |
) |
|||
Interest income, net |
|
7,642 |
|
|
10,274 |
|
|
25,277 |
|
|
29,276 |
|
|||
Other income (expense), net |
|
9 |
|
|
(55 |
) |
|
11 |
|
|
(284 |
) |
|||
Net loss | $ |
(93,551 |
) |
$ |
(201,630 |
) |
$ |
(304,888 |
) |
$ |
(508,783 |
) |
|||
Net loss per share - basic and diluted | $ |
(1.53 |
) |
$ |
(3.37 |
) |
$ |
(5.03 |
) |
$ |
(8.51 |
) |
|||
Weighted average shares outstanding - basic and diluted |
|
61,116,524 |
|
|
59,912,378 |
|
|
60,598,909 |
|
|
59,786,254 |
|
|||
SELECT IMPORTANT SAFETY INFORMATION FOR ZURZUVAE
ZURZUVAE (zuranolone) CIV, is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression in adults.
This does not include all the information needed to use ZURZUVAE safely and effectively. See full prescribing information for ZURZUVAE.
ZURZUVAE may cause serious side effects, including decreased awareness and alertness, which can affect your ability to drive safely or safely do other dangerous activities. Do not drive, operate machinery, or do other dangerous activities until at least 12 hours after taking each dose. You may not be able to tell on your own if you can drive safely or tell how much ZURZUVAE is affecting you. ZURZUVAE may cause central nervous system (CNS) depressant effects including sleepiness, drowsiness, slow thinking, dizziness, confusion, and trouble walking. Taking alcohol, other medicines that cause CNS depressant effects such as benzodiazepines, or opioids while taking ZURZUVAE can make these symptoms worse and may also cause trouble breathing. ZURZUVAE is a federally controlled substance schedule IV because it contains zuranolone, which can be abused or lead to dependence. Tell your healthcare provider right away if you become pregnant or plan to become pregnant during treatment with ZURZUVAE. You should use effective birth control (contraception) during treatment with ZURZUVAE and for 1 week after the final dose. ZURZUVAE and other antidepressant medicines may increase the risk of suicidal thoughts and actions in people 24 years of age and younger. ZURZUVAE is not for use in children. The most common side effects of ZURZUVAE include sleepiness or drowsiness, dizziness, common cold, diarrhea, feeling tired, weak, or having no energy, and urinary tract infection.
SELECT IMPORTANT SAFETY INFORMATION for ZULRESSO
ZULRESSO (brexanolone) CIV, is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression in individuals 15 years and older.
This does not include all the information needed to use ZULRESSO safely and effectively. See full prescribing information for ZULRESSO.
WARNING: EXCESSIVE SEDATION AND SUDDEN LOSS OF CONSCIOUSNESS
See full prescribing information for complete boxed warning
Patients are at risk of excessive sedation or sudden loss of consciousness during administration of ZULRESSO.
Because of the risk of serious harm, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring. Patients must be accompanied during interactions with their child(ren).
ZULRESSO is available only through a restricted program called the ZULRESSO REMS.
WARNINGS AND PRECAUTIONS
Suicidal Thoughts and Behaviors: Consider changing the therapeutic regimen, including discontinuing ZULRESSO, in patients whose PPD becomes worse or who experience emergent suicidal thoughts and behavior.
ADVERSE REACTIONS: Most common adverse reactions (incidence ≥
USE IN SPECIFIC POPULATIONS
- Pregnancy: ZULRESSO may cause fetal harm. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants/
- Renal Impairment: Avoid use of ZULRESSO in patients with end stage renal disease (ESRD)
To report SUSPECTED ADVERSE REACTIONS, contact Sage Therapeutics, Inc. at 1-844-4-SAGERX (1-844-472-4379) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see accompanying full Prescribing Information including Boxed Warning.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241029531414/en/
Investor Contact
Katie Plante
978-968-9099
Katie.Plante@sagerx.com
Media Contact
Francesca Dellelci
856-261-5975
Francesca.Dellelci@sagerx.com
Source: Sage Therapeutics, Inc.
FAQ
What was SAGE's revenue from ZURZUVAE in Q3 2024?
How many ZURZUVAE prescriptions were shipped in Q3 2024?
What is SAGE's cash position as of Q3 2024?