CAMBRIDGE, Mass. / Jul 31, 2024 / Business Wire / Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today reported business highlights and financial results for the second quarter ended June 30, 2024.
“We are pleased with the strength of ZURZUVAE’s early commercial launch performance and its positive, real-world impact on women suffering from PPD. Supported by several tailwinds, including increasing demand among a mix of providers, particularly OBGYNs, we believe ZURZUVAE is well-positioned to become the first line therapy and standard of care for women with PPD,” said Barry Greene, Chief Executive Officer at Sage Therapeutics. “While we are deeply disappointed by the results from the KINETIC 2 study and for the essential tremor community, we remain focused on progressing our pipeline and look forward to additional clinical data readouts expected in late 2024.”
Second Quarter 2024 Portfolio Updates
Sage is advancing a portfolio of internally discovered novel chemical entities with the potential to become differentiated products designed to improve brain health by targeting the GABAA and NMDA receptor systems. Dysfunction in these systems is thought to be at the core of numerous neuropsychiatric disorders.
Postpartum Depression Commercial Products
ZURZUVAE was approved by the FDA in August 2023 as the first-and-only oral treatment specifically indicated for adults with postpartum depression (PPD). ZURZUVAE was made commercially available in December 2023. ZURZUVAE is being developed and commercialized in collaboration with Biogen Inc. Sage also commercializes ZULRESSO® (brexanolone) CIV injection in the treatment of PPD.
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 PPD. The companies are utilizing a specialty pharmacy distribution model by which ZURZUVAE is shipped directly to women with PPD who are prescribed the treatment.
As of the second quarter ended June 30, 2024, the following results had been achieved:
Sage and Biogen field sales teams are engaging in promotional dialogues with HCPs who actively identify and treat women with PPD. In the second quarter of 2024, OBGYNs accounted for more than 70% of prescriptions written, followed by psychiatrists and PCPs. The number of new and repeat ZURZUVAE prescribers grew during the second quarter of 2024.
The companies continue to advance discussions with national, regional and government payors to advocate for broad and equitable access to ZURZUVAE for women with PPD with minimal restrictions and expect formulary discussions to continue over the course of 2024.
Sage and Biogen’s patient support program for women with PPD, ZURZUVAE For You, provides educational resources, help with understanding insurance coverage and assistance navigating the prescription fulfillment process. The program also includes financial assistance, such as a copay assistance program and product at no cost, for eligible patients. In the second quarter of 2024, the vast majority of commercially insured patients using the ZURZUVAE savings card paid no copay.
The Company expects the following milestones for ZURZUVAE in 2024:
Pipeline
Dalzanemdor (SAGE-718)
Dalzanemdor (SAGE-718), the Company’s first-in-class NMDA receptor positive allosteric modulator (PAM), is in development as a potential oral therapy for cognitive impairment associated with neurodegenerative disorders. Dalzanemdor has received Fast Track Designation and Orphan Drug Designation (ODD) from the FDA, and Orphan Drug Designation from the European Medicines Agency (EMA) for the potential treatment of Huntington’s Disease. Dalzanemdor has also been awarded an Innovation Passport Designation for cognitive impairment associated with HD and entry into the Innovative Licensing and Access Pathway (ILAP) by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).
Sage is advancing a clinical program for dalzanemdor with ongoing Phase 2 studies, including the DIMENSION study in people with cognitive impairment associated with Huntington’s Disease (HD), the lead indication for dalzanemdor, and the LIGHTWAVE study in people with mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s Disease (AD).
In June, Sage announced topline results from the SURVEYOR Study. The SURVEYOR Study met its primary endpoint demonstrating a statistically significant difference as measured by the HD-Cognitive Assessment Battery (HD-CAB) composite score at baseline between healthy participants and participants with Huntington’s Disease (HD) prior to any treatment with dalzanemdor (SAGE-718) or placebo, further underscoring the cognitive impact of HD. For participants with HD that received dalzanemdor or placebo, dalzanemdor was generally well-tolerated with no new safety signals observed. There was a small numerical difference observed between dalzanemdor and placebo on the HD-CAB composite score at Day 28. Other prespecified analyses suggested the potential for directionally positive signals in a number of individual component tests of the HD-CAB and in some functional assessments.
Based on the review of data from the SURVEYOR Study and other relevant information, the Company has decided to adjust the primary endpoint in the ongoing placebo-controlled DIMENSION Study in HD from the HD-CAB composite to the Symbol Digit Modalities Test (SDMT), one of the cognitive tests included in the composite. Other secondary endpoints include additional measures of cognition, functioning and safety. Topline data from the DIMENSION Study are expected in late 2024.
Ongoing studies in the dalzanemdor clinical program include:
The Company expects the following milestones for dalzanemdor in 2024:
SAGE-324
SAGE-324 is a GABAA receptor PAM, being developed as a potential oral therapy in collaboration with Biogen Inc.
On July 24, 2024, Sage and Biogen announced topline results from the Phase 2 KINETIC 2 study of SAGE-324 as a potential treatment in ET. The KINETIC 2 Study did not demonstrate a statistically significant dose-response relationship in change from baseline to Day 91 based on the primary endpoint, The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale (PS) Item 4 (upper limb) Total Score, in participants with ET. In addition, there were no statistically significant differences demonstrated for any dose of SAGE-324 versus placebo in the change from baseline to Day 91 on the TETRAS PS Item 4 Total Score or the TETRAS Activities of Daily Living (ADL) Composite Score. Given these results, Sage and Biogen do not plan to conduct further clinical development of SAGE-324 in ET and will close the ongoing open label safety study. The companies are evaluating next steps, if any, for other potential indications.
FINANCIAL RESULTS FOR THE SECOND QUARTER 2024
FINANCIAL GUIDANCE
Conference Call Information
Sage will host a conference call and webcast today, July 31, 2024, at 4:30 p.m. ET to review its second 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 Cambridge, Mass. Find out more at www.sagerx.com or engage with us on Facebook, LinkedIn, Instagram, and X.
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 for ZURZUVAE to become the first line treatment and standard of care in this indication; our expectations as to coverage decisions related to ZURZUVAE in PPD and our goal of broad and equitable access to ZURZUVAE for women with PPD who are prescribed treatment; our belief in the commercial potential and profile for ZURZUVAE in the treatment of women with PPD and our expectations as launch progresses; anticipated timelines for reporting of results with respect to ongoing clinical trials of dalzanemdor and other planned activities; plans to evaluate other potential indications for SAGE-324; 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 expectations as to our cash runway, future expense levels and other financial guidance and statements as to 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: our launch and commercialization efforts in the U.S. with respect to ZURZUVAE for the treatment of women with PPD may not be successful, and we may be unable to generate revenues from sales of ZURZUVAE at the levels or on the timing we expect or at levels or on the timing necessary to support our goals; early positive signs from launch or from our engagements with healthcare professionals, patients and payors related to ZURZUVAE may not be a signal of the potential for future success; the number of women with PPD, the unmet need for additional treatment options, and the potential market for ZURZUVAE in women with PPD, may be significantly smaller than we expect; ZURZUVAE may not achieve the clinical benefit, clinical use or level of market acceptance from healthcare professionals, patients or payors in the treatment of PPD we expect or we may encounter reimbursement-related or other market-related issues or issues with our distribution network that impact the success of our commercialization efforts, including our ability to achieve access goals; ZURZUVAE may never become the first line treatment and standard of care for women with PPD; we may encounter delays in reporting of data with respect to any of our ongoing clinical trials, including as a result of changes in the trials, that may impact our ability to meet our expected timelines and may increase our costs; success in earlier clinical trials of any of our product candidates may not be repeated or observed in ongoing or future studies, and ongoing and future clinical trials may not meet their primary or key secondary endpoints which may substantially impair development or cause us to discontinue development; in particular with respect to dalzanemdor, the results of our ongoing clinical studies of dalzanemdor in HD and AD may be negative like the results we previously announced from the PRECEDENT study in MCI in Parkinson’s Disease; potentially directionally positive signals in certain measures of the treatment phase of the SURVEYOR study of dalzanemdor may not prove to be actual signals or meaningful to the development program; we do not know if adjusting the primary endpoint of the DIMENSION Study will increase the probability of success, and it may not; unexpected concerns may arise from additional data, analysis or results from any of our completed studies; we and our collaborator, Biogen, may jointly or individually determine not to proceed with further development of SAGE-324 in any indication or at all; decisions or actions of the FDA or the timing of meetings with the FDA may affect the timing, design, size, progress and cost of ongoing or future clinical trials of our current or future product candidates, the timing of data read-outs, the planned regulatory pathway or our ability to proceed with further development or may impair the potential for successful development or the timing or success of filing for and gaining regulatory approval; we may encounter adverse events at any stage that negatively impact further development and the potential for approval of our product candidates or the potential for successful commercialization of any our approved products or that require additional nonclinical and clinical work which may not yield positive results; the need to align with our collaborators may hamper or delay our development and commercialization efforts for the products or product candidates that are part of the collaboration or increase our costs; the anticipated benefits of our ongoing collaborations, including the future receipt of payments or the successful development or commercialization of products and generation of revenue, may never be achieved at the levels or timing we expect or at all; our business may be adversely affected and our costs may increase if any of our key collaborators fails to perform its obligations or terminates our collaboration; the internal and external costs required for our ongoing and planned activities, and the resulting impact on expense and use of cash, may be higher than expected which may cause us to not meet our cash runway or expense expectations or we may change or curtail some of our plans or both; we may not be successful in our efforts to gain regulatory approval of products beyond ZURZUVAE and ZULRESSO; we may not achieve revenues from our currently marketed products or any potential future products, at levels we expect; if we do not achieve revenues at the levels we expect from our currently marketed products, we may not achieve our expected cash runway; additional funding may not be available on acceptable terms which could hamper our development and commercialization activities; any of the foregoing events could impair the value creation opportunities for our business; and we may encounter technical and other unexpected hurdles in the development and manufacture of our product candidates or the commercialization of any current or future marketed product which may delay our timing or change our plans, increase our costs or otherwise negatively impact our business; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent quarterly report filed with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.
Financial Tables
| Sage Therapeutics, Inc. and Subsidiaries | |||||
| Condensed Consolidated Balance Sheets | |||||
| (in thousands) | |||||
| (unaudited) | |||||
| June 30, 2024 | December 31, 2023 | ||||
| Cash, cash equivalents and marketable securities | $ | 646,793 | $ | 753,184 | |
| Total assets |
| 697,105 |
| 882,277 | |
| Total liabilities |
| 69,043 |
| 82,747 | |
| Total stockholders' equity |
| 628,062 |
| 799,530 | |
| Sage Therapeutics, Inc. and Subsidiaries | |||||||||||||||
| Condensed Consolidated Statements of Operations | |||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||
| (unaudited) | |||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2024 |
|
| 2023 |
|
| 2024 |
|
| 2023 |
| ||||
| Product revenue, net | $ | 600 |
| $ | 2,460 |
| $ | 2,289 |
| $ | 5,754 |
| |||
| Collaboration revenue - related party |
| 7,420 |
|
| - |
|
| 13,633 |
|
| - |
| |||
| Other collaboration revenue |
| 634 |
|
| 14 |
|
| 634 |
|
| 14 |
| |||
| Total revenues |
| 8,654 |
|
| 2,474 |
|
| 16,556 |
|
| 5,768 |
| |||
| Operating costs and expenses: | |||||||||||||||
| Cost of revenues |
| 1,407 |
|
| 205 |
|
| 2,676 |
|
| 435 |
| |||
| Research and development |
| 62,564 |
|
| 97,161 |
|
| 134,297 |
|
| 189,987 |
| |||
| Selling, general and administrative |
| 55,983 |
|
| 75,565 |
|
| 108,556 |
|
| 141,273 |
| |||
| Total operating costs and expenses |
| 119,954 |
|
| 172,931 |
|
| 245,529 |
|
| 331,695 |
| |||
| Loss from operations |
| (111,300 | ) |
| (170,457 | ) |
| (228,973 | ) |
| (325,927 | ) | |||
| Interest income, net |
| 8,431 |
|
| 10,173 |
|
| 17,634 |
|
| 19,003 |
| |||
| Other income (expense), net |
| 15 |
|
| (41 | ) |
| 2 |
|
| (229 | ) | |||
| Net loss | $ | (102,854 | ) | $ | (160,325 | ) | $ | (211,337 | ) | $ | (307,153 | ) | |||
| Net loss per share - basic and diluted | $ | (1.70 | ) | $ | (2.68 | ) | $ | (3.50 | ) | $ | (5.14 | ) | |||
| Weighted average shares outstanding - basic and diluted |
| 60,538,319 |
|
| 59,769,640 |
|
| 60,337,258 |
|
| 59,722,147 |
| |||
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 ≥5% and at least twice the rate of placebo) were sedation/somnolence, dry mouth, loss of consciousness, and flushing/hot flush.
USE IN SPECIFIC POPULATIONS
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.
| Last Trade: | US$5.10 |
| Daily Change: | -0.27 -5.03 |
| Daily Volume: | 1,156,028 |
| Market Cap: | US$311.360M |
October 29, 2024 June 11, 2024 June 05, 2024 | |
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