Sage Therapeutics Announces First Quarter 2024 Financial Results and Highlights Pipeline and Business Progress
- Achieved $6.2 million in ZURZUVAE collaboration revenue in Q1 2024
- More than 700 prescriptions shipped and delivered in Q1 2024
- Payor coverage expanded for ZURZUVAE in treating women with PPD
- Phase 2 PRECEDENT Study did not show significant differences versus placebo
- Cash, cash equivalents, and marketable securities of $717 million as of March 31, 2024
- Phase 2 PRECEDENT Study did not meet primary endpoint
- Decrease in ZULRESSO net revenues from $3.3 million in Q1 2023 to $1.7 million in Q1 2024
- Net loss of $108.5 million in Q1 2024 compared to $146.8 million in Q1 2023
Insights
Scrutinizing the financial results of Sage Therapeutics, particularly their collaboration revenue from ZURZUVAE, there's an observed initial surge post-launch with
However, the gradual decrease in ZULRESSO revenue suggests a transitioning product mix focus, something investors should monitor. Also, the lack of anticipated milestone payments for the rest of the year means current revenue streams need to be reliable for future growth.
Analyzing Sage Therapeutics' pipeline progress, the Phase 2 trial failure for dalzanemdor in Parkinson's Disease is a setback. The failure to meet the primary endpoint diminishes its potential market reach, redirecting the company's resources to other indications such as Huntington's Disease and Alzheimer's Disease, where topline data are anticipated later this year. These milestones are critical, as success could open up a substantial market opportunity given the unmet needs in neurodegenerative disorders. On the other hand, developments in the postpartum depression (PPD) space with ZURZUVAE show potential, supported by strong payor coverage, which could bode well for market penetration and patient access.
Investors should note the strategic importance of PPD treatment within Sage's portfolio, as it's currently driving the commercial narrative. The added value of being the first-and-only FDA-approved oral treatment specifically for adults with PPD gives ZURZUVAE a competitive edge.
The coverage by payors is a linchpin for the successful commercialization of new pharmaceuticals. Sage's report of over 65% of commercial lives covered for ZURZUVAE, including two national PBMs, is significant. Negotiations with a third PBM and ongoing Medicaid reviews will further the drug's footprint. This broad coverage without stringent prior authorizations is commendable in the current health insurance environment and a positive indicator for patient accessibility. The company's patient support program, which offers financial assistance and navigates the insurance landscape, is another strategic move aimed at mitigating out-of-pocket costs, thereby potentially increasing patient adherence and treatment uptake.
While the progress with payors is solid, the financial sustainability of these programs and the impact on net pricing per prescription remain factors for investors to watch and they will undoubtedly influence the long-term commercial success of ZURZUVAE.
Achieved
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 women with postpartum depression (PPD) without step therapy or complex prior authorizations, including coverage from two national Pharmacy Benefit Managers (PBMs)
Phase 2 PRECEDENT Study did not show statistically significant differences versus placebo on primary endpoint in patients with mild cognitive impairment in Parkinson’s Disease; Topline data expected for dalzanemdor (SAGE-718) in Huntington’s Disease and Alzheimer’s Disease in 2024
Cash, cash equivalents and marketable securities of
“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
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
As of the first quarter ended March 31, 2024, the following results had been achieved:
-
$6.2 million 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
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 $753 million -
Revenue: Collaboration revenue from sales of ZURZUVAE was
$6.2 million 50% of the net revenues Biogen reports for ZURZUVAE in theU.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 $1.7 million $3.3 million -
R&D Expenses: Research and development expenses were
$71.7 million $5.0 million $92.8 million $8.8 million $5.7 million $17.3 million -
SG&A Expenses: Selling, general and administrative expenses were
$52.6 million $8.7 million $65.7 million $11.3 million $2.3 million $3.0 million -
Net Loss: Net loss was
$108.5 million $146.8 million
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.
Conference Call Information
Sage will host a conference call and webcast today, Thursday, April 25, at 8:00 a.m. ET to review its first 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 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 certain of our other programs; 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
Financial Tables
| Sage Therapeutics, Inc. and Subsidiaries | |||||||
| Condensed Consolidated Balance Sheets | |||||||
| (in thousands) | |||||||
| (unaudited) | |||||||
| March 31, 2024 | December 31, 2023 | ||||||
| Cash, cash equivalents and marketable securities | $ |
717,013 |
|
$ |
753,184 |
|
|
| Total assets |
|
767,600 |
|
|
882,277 |
|
|
| Total liabilities |
|
61,799 |
|
|
82,747 |
|
|
| Total stockholders' equity |
|
705,801 |
|
|
799,530 |
|
|
| Sage Therapeutics, Inc. and Subsidiaries | |||||||
| Condensed Consolidated Statements of Operations | |||||||
| (in thousands, except share and per share data) | |||||||
| (unaudited) | |||||||
| Three Months Ended March 31, | |||||||
|
2024 |
|
|
2023 |
|
||
| Product revenue, net | $ |
1,690 |
|
$ |
3,294 |
|
|
| Collaboration revenue - related party |
|
6,212 |
|
|
- |
|
|
| Total revenue |
|
7,902 |
|
|
3,294 |
|
|
| Operating costs and expenses: | |||||||
| Cost of revenues |
|
1,269 |
|
|
230 |
|
|
| Research and development |
|
71,734 |
|
|
92,826 |
|
|
| Selling, general and administrative |
|
52,574 |
|
|
65,708 |
|
|
| Total operating costs and expenses |
|
125,577 |
|
|
158,764 |
|
|
| Loss from operations |
|
(117,675 |
) |
|
(155,470 |
) |
|
| Interest income, net |
|
9,204 |
|
|
8,830 |
|
|
| Other expense, net |
|
(12 |
) |
|
(188 |
) |
|
| Net loss | $ |
(108,483 |
) |
$ |
(146,828 |
) |
|
| Net loss per share - basic and diluted | $ |
(1.80 |
) |
$ |
(2.46 |
) |
|
| Weighted average shares outstanding - basic and diluted |
|
60,136,198 |
|
|
59,674,127 |
|
|
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/20240425567718/en/
Investors
Ashley Kaplowitz
786-252-1419
ashley.kaplowitz@sagerx.com
Media
Matthew Henson
917-930-7147
matthew.henson@sagerx.com
Source: Sage Therapeutics, Inc.
FAQ
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