05/03/2018 | Press release | Archived content
New Drug Application for intravenous (IV) formulation of brexanolone as a treatment for postpartum depression submitted to U.S. Food and Drug Administration
Significant progress achieved in launch readiness preparations in anticipation of potential 1H 2019 brexanolone IV launch
Broad pipeline of drug candidates to treat central nervous system disorders continues to advance, with at least 7 clinical trial programs expected to be ongoing in 2018
Conference call today at 8:00 AM ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 3, 2018-- Sage Therapeutics, Inc. (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today reported business highlights and financial results for the first quarter ended March 31, 2018.
"At Sage, we are focused on improving patient care through innovation. In the first half of 2018, we made great progress toward achieving that mission by accelerating launch preparation activities and R&D efforts across our portfolio," said Jeff Jonas, M.D., chief executive officer of Sage. "We have taken important steps to further Sage's planned transition to a commercial stage company, starting with the submission of our New Drug Application (NDA) for brexanolone IV, expansion of our commercial leadership, and the build-out of our patient support organization in advance of a potential approval. At the same time, we look forward to moving three additional drug candidates forward through 7 clinical programs, several of which we expect to initiate in the coming months. The commercial and development milestones we hope to achieve this year are focused on our goal of making a positive impact on the lives of patients suffering with serious CNS conditions and their caregivers."
Launch Readiness Updates:
Pipeline Updates:
Sage is advancing a portfolio of novel CNS product candidates targeting the GABA and NMDA receptor systems. Dysfunction in these systems is known to be at the core of numerous psychiatric and neurological disorders.
GABA Programs
Sage is developing its proprietary IV formulation of brexanolone and a pipeline of novel, next-generation, positive allosteric GABA modulators, including SAGE-217 and SAGE-324.
NMDA Programs
Sage is developing novel, oral, first-in-class oxysterol-based positive allosteric modulators of the NMDA receptor, which may have potential in the treatment of a range of neurological disorders associated with a variety of cognitive, neurological and behavioral symptoms.
Disease Education Initiatives:
Expected Milestones
Financial Results for the First Quarter of 2018
"We continue to be very strategic in the investments we make across the organization to ensure our ability to maximize the potential of our development-stage and pre-commercial assets," said Kimi Iguchi, chief financial officer of Sage. "With over $1 billion in cash, we are confident in the strength of our balance sheet to continue to support advancement of the pipeline and ongoing launch preparation."
Financial Guidance:
Conference Call Information
Sage will host a conference call and webcast today at 8:00 AM ET to discuss its first quarter financial results and recent corporate updates. The live webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. The conference call can be accessed by dialing (866) 450-8683 (toll-free domestic) or (281) 542-4847 (international) and using the conference ID 1675388. A replay of the webcast will be available on Sage's website approximately two hours after the completion of the event and will be archived for up to 30 days.
About Sage Therapeutics
Sage Therapeutics is a clinical-stage biopharmaceutical company committed to developing novel medicines to transform the lives of patients with life-altering central nervous system (CNS) disorders. Sage has a portfolio of novel product candidates targeting critical CNS receptor systems, GABA and NMDA. Sage's lead program, a proprietary IV formulation of brexanolone (SAGE-547), has completed Phase 3 clinical development for postpartum depression. Sage is developing its next generation modulators, including SAGE-217 and SAGE-718, in various CNS disorders. For more information, please visit www.sagerx.com.
Forward-Looking Statements
Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation: our expectations regarding acceptance by the FDA for filing and review of our NDA submission seeking approval of brexanolone IV in the treatment of PPD, and the potential for approval of the NDA; our expectations regarding our possible transition to a commercial-stage company, including the timing of a potential launch of brexanolone IV in PPD; our plans and expectations regarding our future commercial activities, if brexanolone IV is approved, including our expectations regarding the availability of home infusion and other potential sites of care and the nature of our planned patient support model; our statements regarding plans and timelines for further development of SAGE-217 and our other product candidates and related activities and our view of the potential for successful development; our statements as to the potential for expedited development for SAGE-217 in MDD as a result of the Breakthrough Therapy designation; our views as to the opportunity represented by Sage's portfolio and business, and the potential for value creation; and our expectations regarding the strength of our balance sheet, the potential for future revenue and future cash needs. 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: the FDA may decide not to accept for filing our NDA for brexanolone IV in PPD; the clinical and non-clinical data we have generated with our proprietary formulation of brexanolone to date may be determined by regulatory authorities, despite prior advice, to be insufficient to file for or gain regulatory approval to launch and commercialize our product in PPD and regulatory authorities may determine that additional trials or data are necessary in order to file for or obtain approval; regulatory authorities may find fault with the data generated at particular clinical site or sites or with the activities of our trial monitor or may disagree with our analyses of the results of our trials or identify issues with our manufacturing or quality systems, and any such findings or issues could require additional data or analyses or changes to our systems that could delay or prevent us from gaining approval of brexanolone IV; even if brexanolone IV is approved in PPD, we may encounter issues, delays or other challenges in launching or commercializing the product, including issues related to market acceptance and reimbursement, regulatory and other challenges or restrictions related to enabling home infusion and other venues as options for site of administration of brexanolone IV, and challenges associated with the build of our sales and patient support organizations and their activities; we may encounter unexpected safety or tolerability issues with brexanolone IV, SAGE-217 or any of our other product candidates in ongoing or future development; we may not be able to successfully demonstrate the efficacy and safety of SAGE-217 or any of our other product candidates at each stage of development; success in early stage clinical trials may not be repeated or observed in ongoing or future studies of SAGE-217 or any of our other product candidates; ongoing and future clinical results may not support further development or be sufficient to gain regulatory approval to market SAGE-217 or any of our other product candidates; we may decide that a development pathway for one of our product candidates in one or more indications is no longer feasible or advisable or that the unmet need no longer exists; we may not achieve expedited development or review of SAGE-217 as a result of the Breakthrough Therapy designation; decisions or actions of the FDA or other regulatory agencies may affect the initiation, timing, design, size, progress and cost of clinical trials and our ability to proceed with further development; we may experience slower than expected enrollment in ongoing clinical trials; the internal and external costs required for our activities, and to build our organization in connection with such activities, and the resulting use of cash, may be higher than expected, or we may conduct additional clinical trials or pre-clinical studies, or engage in new activities, requiring additional expenditures and using cash more quickly than anticipated; and we may encounter technical and other unexpected hurdles in the development, manufacture and potential future commercialization of our product candidates; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent Quarterly Report on Form 10-Q, and 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.
Sage Therapeutics, Inc. and Subsidiaries | ||||||||
Condensed Consolidated Balance Sheets | ||||||||
(in thousands) | ||||||||
(Unaudited) |
||||||||
March 31, 2018 | December 31, 2017 | |||||||
Assets | ||||||||
Current Assets: | ||||||||
Cash and cash equivalents | $ | 557,555 | $ | 306,235 | ||||
Marketable securities | 525,958 | 212,613 | ||||||
Prepaid expenses and other current assets | 11,575 | 6,227 | ||||||
Total current assets | 1,095,088 | 525,075 | ||||||
Property and equipment and other long-term assets | 5,564 | 4,862 | ||||||
Total assets | $ | 1,100,652 | $ | 529,937 | ||||
Liabilities and Stockholders' Equity | ||||||||
Current Liabilities: | ||||||||
Accounts payable | $ | 8,350 | $ | 9,350 | ||||
Accrued expenses | 29,522 | 42,601 | ||||||
Total current liabilities | 37,872 | 51,951 | ||||||
Other liabilities | 3,504 | 2,511 | ||||||
Total liabilities | 41,376 | 54,462 | ||||||
Total stockholders' equity | 1,059,276 | 475,475 | ||||||
Total liabilities and stockholders' equity | $ | 1,100,652 | $ | 529,937 | ||||
Sage Therapeutics, Inc. and Subsidiaries | ||||||||||
Condensed Consolidated Statements of Operations | ||||||||||
(in thousands, except share and per share data) | ||||||||||
(Unaudited) |
||||||||||
Three Months Ended March 31, | ||||||||||
2018 | 2017 | |||||||||
Operating expenses: | ||||||||||
Research and development | $ | 49,270 | $ | 45,200 | ||||||
General and administrative | 28,849 | 12,280 | ||||||||
Total operating expenses | 78,119 | 57,480 | ||||||||
Loss from operations | (78,119 | ) | (57,480 | ) | ||||||
Interest income, net | 3,529 | 707 | ||||||||
Other expense, net | (8 | ) | (5 | ) | ||||||
Net loss | $ | (74,598 | ) | $ | (56,778 | ) | ||||
Net loss per share - basic and diluted | $ | (1.68 | ) | $ | (1.52 | ) | ||||
Weighted average shares outstanding - basic and diluted | 44,325,371 | 37,269,148 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20180503005195/en/
Source: Sage Therapeutics, Inc.
Investor Contact:
Paul Cox, 617-299-8377
paul.cox@sagerx.com
or
Media Contact:
Maureen L. Suda, 585-355-1134
maureen.suda@sagerx.com