CAMBRIDGE, Mass.–(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 first quarter ended March 31, 2024.
“The launch of ZURZUVAE is off to an encouraging start, reflected in the strong performance in the first full quarter of the launch. We are seeing increasing demand among HCPs, particularly OBGYNs, and hearing inspiring success stories from women with PPD treated with ZURZUVAE. Importantly, momentum in commercial and government payor coverage is helping to support our goal of broad and equitable access for women with PPD,” said Barry Greene, Chief Executive Officer at Sage Therapeutics. “In parallel, we are working with urgency to advance efforts across our pipeline. While we are disappointed by the results of the Phase 2 PRECEDENT study given the significant burden of mild cognitive impairment on people and families affected by Parkinson’s Disease, we look forward to the other data readouts for dalzanemdor and SAGE-324 expected in 2024.”
First Quarter 2024 Portfolio Updates
Sage is advancing a portfolio of clinical-stage programs featuring 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 neurological and 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 PPD. ZURZUVAE was made commercially available in the U.S. in December 2023. ZURZUVAE is being developed and commercialized in collaboration with Biogen Inc. Sage also commercializes ZULRESSO® (brexanolone) CIV injection in the U.S. 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 in the U.S. for women with PPD. ZURZUVAE was made commercially available in the U.S. in December 2023. The companies are utilizing a specialty pharmacy distribution model by which ZURZUVAE is shipped directly to those who are prescribed the treatment.
As of the first quarter ended March 31, 2024, the following results had been achieved:
- $6.2 million in collaboration revenue from ZURZUVAE, representing 50% of the net revenues recorded when Biogen shipped ZURZUVAE to the wholesalers. ZURZUVAE net revenues for the first quarter can be attributed to a combination of wholesalers purchasing ZURZUVAE to fill orders as well as building inventory in anticipation of increasing demand for ZURZUVAE in the treatment of women with PPD.
- Over 1,200 prescriptions written across a wide breadth of physician types who treat PPD, including psychiatrists, OBGYNs and primary care physicians (PCPs).
- In the first quarter of 2024, more than 700 prescriptions were shipped and delivered.
Sage and Biogen field sales teams are engaging in promotional dialogues with HCPs who actively identify and treat women with PPD. In the first quarter of 2024, OBGYNs accounted for the largest share of prescriptions, followed by psychiatrists and PCPs. The number of new ZURZUVAE prescribers grew each month during the first 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.
- In the first quarter of 2024, the majority of prescriptions were covered by payors.
- As of mid-April 2024, over 65% of all commercial lives are covered by payor policies in PPD, with the majority having no step therapy or complex prior authorizations, including two of three national PBMs who have developed coverage policies for ZURZUVAE in the treatment of PPD. Conversations are progressing with the third national PBM.
- Medicaid reviews are ongoing with almost half of the states, including several of the largest states, completing reviews during the first quarter of 2024. The companies expect the majority of Medicaid coverage decisions in PPD by the end of 2024.
Sage and Biogen’s patient support program, ZURZUVAE For You, provides educational resources, helps with understanding insurance coverage and assistance navigating the prescription fulfillment process for women with PPD who are prescribed treatment. The program also includes financial assistance, such as a copay assistance program and product at no cost, for eligible patients. In the first quarter of 2024, the majority of commercially-insured patients using the ZURZUVAE savings card paid no copay.
The Company expects the following milestones for ZURZUVAE in 2024:
- 2024:
- Ongoing commercialization of ZURZUVAE in the treatment of women with PPD
- Present additional analyses of data from NEST clinical program, including health economics and patient reported outcomes
Pipeline
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 certain 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 Huntington’s Disease and entry into the Innovative Licensing and Access Pathway (ILAP) by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). SAGE-324, the Company’s next-generation PAM of GABAA receptors, is in development as a potential oral therapy for essential tremor (ET). SAGE-324 is being developed in collaboration with Biogen Inc.
Dalzanemdor (SAGE-718)
Sage is advancing a robust clinical program for dalzanemdor with multiple ongoing Phase 2 studies, including the DIMENSION and SURVEYOR studies 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).
On April 17, 2024, Sage announced topline results from PRECEDENT, a double-blind, placebo-controlled Phase 2 study of dalzanemdor in people with MCI in Parkinson’s Disease. The PRECEDENT Study did not meet its primary endpoint of demonstrating statistically significant difference from baseline in participants treated with once-daily dalzanemdor versus placebo on the Wechsler Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test score at Day 42. Dalzanemdor was generally well-tolerated, and there were no new safety signals observed. Based on the data, the Company does not plan any further development of dalzanemdor in Parkinson’s Disease.
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 people with cognitive impairment associated with HD. The study is designed to evaluate the efficacy of dalzanemdor dosed over a 12-week period, with a target enrollment of approximately 178 people. The DIMENSION Study is enrolling across 40 clinical sites.
- SURVEYOR (CIH-202) Study: The SURVEYOR Study is a double-blind, placebo-controlled Phase 2 study in people with cognitive impairment associated with HD. The SURVEYOR Study is designed to generate evidence linking changes in cognition to functioning, and is not designed or powered to demonstrate a statistically significant difference between dalzanemdor and placebo.
- PURVIEW (CIH-301) Study: The PURVIEW Study is an open-label Phase 3 safety study of dalzanemdor in people with cognitive impairment associated with HD. The study is designed to evaluate the long-term safety profile and long-term functioning compared to HD natural history of those treated for one year or more.
- LIGHTWAVE (CNA-202) Study: The LIGHTWAVE Study is a double-blind, placebo-controlled Phase 2 study of dalzanemdor in people with MCI and mild dementia due to AD. The study is designed to evaluate the safety and efficacy of dalzanemdor dosed over a 12-week period.
The Company expects the following milestones for dalzanemdor in 2024:
- Mid-2024:
- Report topline data from SURVEYOR Study in people with HD cognitive impairment
- Late 2024:
- Report topline data from LIGHTWAVE Study in people with MCI and mild dementia due to AD
- Report topline data from DIMENSION Study in people with HD cognitive impairment
- 2024:
- Present additional analyses of data from clinical development program as well as disease state and burden of disease research in HD and/or AD
SAGE-324
Sage and its collaborator, Biogen, have completed enrollment in the Phase 2b KINETIC 2 placebo-controlled study of SAGE-324 in ET, which follows positive results from the completed KINETIC Study of SAGE-324 in ET. KINETIC 2 is a Phase 2b dose-ranging study with the primary goal of defining the dose for SAGE-324 with an efficacy and tolerability profile that maintains plasma concentrations needed for sustained tremor symptom control in treating ET. Topline data from the KINETIC 2 Study are expected in mid-2024.
Sage is also enrolling patients in a Phase 2 long-term open-label safety study to evaluate the long-term safety and tolerability of SAGE-324 in ET. The primary endpoint is incidence of treatment-emergent adverse events.
The Company expects the following milestones for SAGE-324 in 2024:
- Mid-2024:
- Report topline data from Phase 2b KINETIC 2 Study in people with ET
- 2024:
- Present additional analyses of data from clinical development program as well as disease state and burden of disease research in ET
FINANCIAL RESULTS FOR THE FIRST QUARTER 2024
- Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2024 were $717 million compared to $753 million at December 31, 2023.
- Revenue: Collaboration revenue from sales of ZURZUVAE was $6.2 million in the first quarter of 2024, the first full quarter of sales. Reported collaboration revenue is 50% of the net revenues Biogen reports for ZURZUVAE in the U.S. ZURZUVAE net revenues for the first quarter can be attributed to a combination of wholesalers purchasing ZURZUVAE to fill orders as well as building inventory in anticipation of increasing demand for ZURZUVAE in the treatment of women with PPD. A $75.0 million milestone payment was earned in the fourth quarter of 2023 upon the first commercial sale of ZURZUVAE in PPD and was received from Biogen in January 2024. Net revenue from sales of ZULRESSO was $1.7 million in the first quarter of 2024, compared to $3.3 million in the same period of 2023.
- R&D Expenses: Research and development expenses were $71.7 million, including $5.0 million of non-cash stock-based compensation expense, in the first quarter of 2024 compared to $92.8 million, including $8.8 million of non-cash stock-based compensation expense, for the same period in 2023. The decrease in R&D expenses was primarily due to decreased headcount, decreased spend on early-stage pipeline, decreased zuranolone clinical trials and manufacturing as result of the Q3 2023 restructuring, partially offset by higher spend on dalzanemdor trials. The reimbursement from Biogen to Sage for R&D expenses pursuant to the Sage/Biogen Collaboration and License Agreement was $5.7 million in the first quarter of 2024 compared to $17.3 million in the same period of 2023, the reduction a result of the lower spend on zuranolone clinical development and manufacturing.
- SG&A Expenses: Selling, general and administrative expenses were $52.6 million, including $8.7 million of non-cash stock-based compensation expense, in the first quarter of 2024, compared to $65.7 million, including $11.3 million of non-cash stock-based compensation expense, for the same period in 2023. The decrease in SG&A expenses was primarily due to decreased headcount, overhead and technology spend as a result of the Q3 2023 restructuring. The reimbursement from Sage to Biogen for SG&A expenses pursuant to the Sage/Biogen Collaboration and License Agreement was $2.3 million in the first quarter of 2024 as compared to $3.0 million in the same period of 2023.
- Net Loss: Net loss was $108.5 million for the first quarter of 2024 compared to $146.8 million for the same period in 2023.
FINANCIAL GUIDANCE
- Based upon the Company’s current operating plan, Sage anticipates that its existing cash, cash equivalents and marketable securities, anticipated funding from ongoing collaborations, and estimated revenues, will support its operations into 2026.
- The Company does not anticipate receipt of any additional milestone payments from collaborations in the remainder of 2024.
- The Company anticipates operating expenses will decrease in 2024 relative to 2023.
- With the availability of ZURZUVAE in the U.S. as an additional treatment for women with PPD, the Company anticipates ZULRESSO revenues will continue to decrease over time.
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.
