08/07/2018 | Press release | Archived content
Conditional acceptance granted by U.S. Food and Drug Administration (FDA) for the proprietary name ZULRESSO™ for Sage's intravenous formulation of brexanolone
Continuing to execute commercial build and launch readiness for ZULRESSO™ (brexanolone injection) in postpartum depression ahead of PDUFA target date of December 19, 2018
Accelerating breakthrough pivotal program for SAGE-217 in depression with key trial milestones expected in 4Q 2018
Progressed clinical pipeline with SAGE-718 Phase 1 multiple ascending dose and SAGE-324 Phase 1 single ascending dose trial initiations and planned SAGE-217 Phase 2 trial initiation in bipolar depression
Conference call today at 8:00 AM ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 7, 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 second quarter ended June 30, 2018.
"This quarter we continued to make great progress on our journey to become a multinational biotech company," said Jeff Jonas, M.D., chief executive officer of Sage. "This was underscored by the regulatory milestones and commercial launch readiness activities in support of ZULRESSO™ (brexanolone injection), the initiation of our strategic collaboration with Shionogi on the development and commercialization of SAGE-217 in key Asian markets, and the ongoing advancement of our early stage drug candidates, SAGE-718 and SAGE-324, into new Phase 1 clinical studies. With the upcoming potential approval and launch of ZULRESSO, we remain focused in our approach to forge news paths for the treatments of CNS disorders."
ZULRESSO Regulatory, Commercial and Pre-Launch Activities Updates:
Pipeline Updates:
Beyond ZULRESSO, 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.
Disease Education Initiatives:
Expected Milestones
Financial Results for the Second Quarter of 2018
"We are excited to announce that our collaboration with Shionogi, in the second quarter, enabled Sage to book revenue for the first time," said Kimi Iguchi, chief financial officer of Sage. "This capital further strengthens our financial position and provides us the ability to make aggressive investments in our late-stage assets, ZULRESSO and SAGE-217, as well as in earlier-stage assets, such as SAGE-324 and SAGE-718. Sage's cost-efficient approach to drug development, our diverse pipeline, and our focus on larger markets with substantial patient populations, represents a unique value proposition with near, intermediate and long-term opportunities."
Financial Guidance:
Conference Call Information
Sage will host a conference call and webcast on Tuesday, August 7, 2018 at 8:00 A.M. ET to report its second quarter 2018 financial results and to discuss recent business 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 5396188. 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 CNS disorders. Sage's lead product candidate, ZULRESSO™ (brexanolone injection), has completed Phase 3 clinical development for postpartum depression and a New Drug Application is currently under review with the U.S. Food and Drug Administration. Sage is developing a portfolio of novel product candidates targeting critical CNS receptor systems, including SAGE-217, which is in Phase 3 development in major depressive disorder and postpartum depression. 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 the potential for approval of our NDA for brexanolone IV in the treatment of PPD; our expectations regarding our possible transition to a commercial-stage company, including the timing of a potential decision by the FDA and potential launch of brexanolone IV in PPD; our plans and expectations regarding our future commercial activities in the U.S., if brexanolone IV is approved, including the potential 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 planned clinical and regulatory activities; our expectations regarding the potential sufficiency of our planned SAGE-217 development program, if successful, to support regulatory filing and approval of SAGE-217 in MDD and PPD; our views as to the potential of SAGE-217 to represent a potential paradigm shift in the treatment of MDD; 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 approve 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 the FDA and other regulatory authorities, despite prior advice, to be insufficient to 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 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, regulatory authorities may impose significant restrictions or conditions on use or on administration, including on sites of care; we may encounter issues, delays or other challenges in launching or commercializing the product, including issues related to market acceptance and reimbursement, challenges associated with any restrictions or conditions that may be imposed by regulatory authorities, including any challenges or restrictions related to enabling home infusion and other venues as viable options for site of administration of brexanolone IV, and challenges associated with the build of our sales and patient support organizations and their activities, which in each case could limit the potential of our product; 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 achieve expedited development or review of SAGE-217; the FDA may ultimately decide that the design or results of our planned clinical trials for SAGE-217 even if positive are not sufficient for regulatory approval in MDD, PPD or any other indication or do not support episodic treatment of MDD which is the focus of our expedited development plan; we may not be successful in our development of SAGE-217 or in our development of any of our product candidates in any indication we are currently pursuing or may in the future pursue; 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 of our 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; 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 |
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Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||||||
Collaboration revenue | $ | 90,000 | $ | - | $ | 90,000 | $ | - | |||||||||||
Operating expenses: | |||||||||||||||||||
Research and development | 68,980 | 55,900 | 118,250 | 101,100 | |||||||||||||||
General and administrative | 43,167 | 14,954 | 72,016 | 27,234 | |||||||||||||||
Total operating expenses | 112,147 | 70,854 | 190,266 | 128,334 | |||||||||||||||
Loss from operations | (22,147 | ) | (70,854 | ) | (100,266 | ) | (128,334 | ) | |||||||||||
Interest income, net | 5,137 | 672 | 8,666 | 1,379 | |||||||||||||||
Other expense, net | 32 | (20 | ) | 24 | (24 | ) | |||||||||||||
Net loss | $ | (16,978 | ) | $ | (70,202 | ) | $ | (91,576 | ) | $ | (126,979 | ) | |||||||
Net loss per share - basic and diluted | $ | (0.36 | ) | $ | (1.88 | ) | $ | (2.02 | ) | $ | (3.40 | ) | |||||||
Weighted average shares outstanding - basic and diluted | 46,541,716 | 37,361,129 | 45,439,666 | 37,315,393 | |||||||||||||||
Sage Therapeutics, Inc. and Subsidiaries |
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June 30, 2018 | December 31, 2017 | ||||||||
Assets | |||||||||
Current Assets: | |||||||||
Cash and cash equivalents | $ | 325,830 | $ | 306,235 | |||||
Marketable securities | 766,603 | 212,613 | |||||||
Prepaid expenses and other current assets | 12,958 | 6,227 | |||||||
Receivable from collaborator | 18,378 | - | |||||||
Total current assets | 1,123,769 | 525,075 | |||||||
Property and equipment and other long-term assets | 5,714 | 4,862 | |||||||
Total assets | $ | 1,129,483 | $ | 529,937 | |||||
Liabilities and Stockholders' Equity | |||||||||
Current Liabilities: | |||||||||
Accounts payable | $ | 8,338 | $ | 9,350 | |||||
Accrued expenses | 39,581 | 42,601 | |||||||
Total current liabilities | 47,919 | 51,951 | |||||||
Other liabilities | 3,801 | 2,511 | |||||||
Total liabilities | 51,720 | 54,462 | |||||||
Total stockholders' equity | 1,077,763 | 475,475 | |||||||
Total liabilities and stockholders' equity | $ | 1,129,483 | $ | 529,937 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20180807005172/en/
Source: Sage Therapeutics, Inc.
Sage Therapeutics
Investor Contact:
Paul Cox, 617-299-8377
paul.cox@sagerx.com
or
Media Contact:
Maureen L. Suda, 585-355-1134
maureen.suda@sagerx.com