Full Press Release Details
Sage Therapeutics Announces Fourth Quarter and Full Year 2016 Financial
Results and Provides Corporate Update
Continued momentum expected in 2017 with several programs anticipating clinical trial results
this year, including two Phase 3 programs
Phase 2 placebo-controlled study of SAGE-217 in major depressive disorder
expected to begin in 1H 2017
First NMDA candidate, SAGE-718, planned to enter Phase 1 clinical testing in 1H 2017
Jim Doherty, Ph.D., promoted to Chief Research Officer to lead Sage s new
Experimental Medicine group
Conference call today at 8:00 AM ET
CAMBRIDGE, Mass., February 23, 2017 Sage Therapeutics, Inc. (NASDAQ: SAGE) today reported business
highlights and financial results for the fourth quarter and full year ended December 31, 2016.
Sage is continuing its vision to
rethink the development of treatments for central nervous system disorders and, in doing so, attempting to close the innovation gap in an area of disease that represents approximately one-third of
the worldwide burden of illness. We are now at a point of significant momentum following the pipeline transformation witnessed in 2016, resulting in at least eight anticipated data readouts across multiple different mood, movement and neurological
disorders this year, including the results we announced earlier this month. In addition, plans are underway for our potential first commercial launch in 2018, said Jeff Jonas, M.D., Chief Executive Officer of Sage. We believe that a key
element of our success to date has been our utilization of novel and efficient approaches to translational science facilitating the discovery and clinical development of our differentiated investigational medicines. Our new Experimental Medicine
group, led by Jim Doherty, Ph.D., will further build on this expertise by establishing a translational foundation across our discovery and clinical programs that we believe will better position Sage for long-term success.
Recent Corporate Highlights
Sage is advancing a portfolio of
novel central nervous system (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. Sage is pursuing a data-driven approach
to CNS drug development by employing efficient human proof-of-concept studies to uncover both activity signals and to help understand future trial methodology, before
investing in larger clinical programs.
Expected Near-Term Clinical Milestones
Financial Results for the Fourth Quarter and Full Year 2016
Conference Call Information
Sage will host a conference call and webcast today at 8:00 AM ET to discuss its fourth quarter and year-end 2016 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 1-866-450-8683 (toll-free domestic) or 1-281-542-4847
(international) and using the conference ID 69937798. 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, brexanolone (SAGE-547), is in Phase 3 clinical development for super-refractory status epilepticus, a rare and severe seizure disorder, and for postpartum depression. Sage is developing its
next generation modulators, including SAGE-217 and SAGE-718, with a focus on acute and chronic CNS disorders. For more information, please visit www.sagerx.com.
Forward-Looking Statements
in this release concern Sage s future expectations, plans and prospects, including without limitation: our expectations for 2017; our expectations regarding development
of our product candidates and their potential in the treatment of various CNS disorders; the expected timing of initiation and completion of clinical trials; the anticipated availability and
announcement of data and results from clinical trials of our product candidates; our goals and expectations with respect to our discovery and translational science efforts; our plans for evaluation of new indications and new compounds; our
expectations regarding the regulatory pathway for brexanolone (SAGE-547) in the treatment of SRSE in the EU, and our belief that the results of the current development program for brexanolone in SRSE, if successful, will be sufficient for an MAA
filing in the EU; our expectations regarding a potential future NDA filing and commercial launch of brexanolone, if successfully developed and approved; and our expectations with respect to future cash use and 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: we may continue to experience slower than expected enrollment and randomization of evaluable patients in the STATUS trial or slower than expected clinical site initiation and enrollment in
our other clinical trials, or the potential need for additional analysis or data or the need to enroll additional patients, leading to possible delays in completion of trials or in the availability of data; we may not be able to generate supportive
non-clinical data or to successfully demonstrate the efficacy and safety of our product candidates at each stage of clinical development; success in our non-clinical studies or in earlier stage clinical trials may not be repeated or
observed in ongoing or future studies involving the same compound or other product candidates, and ongoing and future pre-clinical and clinical results may not support further development of product candidates or be sufficient to gain regulatory
approval to launch and commercialize any product; decisions or actions of regulatory agencies may affect the initiation, timing, progress and cost of clinical trials, and our ability to proceed with further clinical studies of a product candidate or
to obtain marketing approval, including the risk that the EMA may, despite scientific advice, decide that the data from our Phase 3 trial in SRSE are not sufficient to support approval; 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 and manufacture of our products which may delay our timing or increase our expenses and use of
cash, as well as those risks more fully discussed in the section entitled Risk Factors in our most recent Quarterly Report on Form 10-Q, 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.
Paul Cox, Sage Therapeutics
Maureen L. Suda, Suda Communications LLC
Sage Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
| December 31, 2016 | December 31, 2015 | |||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 168,517 | $ | 186,753 | ||||
| Marketable securities | 228,962 | |||||||
| Prepaid expenses and other current assets | 5,100 | 1,738 | ||||||
| Total current assets | 402,579 | 188,491 | ||||||
| Property and equipment and other long-term assets | 1,952 | 525 | ||||||
| Total assets | $ | 404,531 | $ | 189,016 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 12,817 | $ | 5,159 | ||||
| Accrued expenses | 22,352 | 10,148 | ||||||
| Total current liabilities | 35,169 | 15,307 | ||||||
| Other liabilities | 845 | 14 | ||||||
| Total liabilities | 36,014 | 15,321 | ||||||
| Total stockholders equity | 368,517 | 173,695 | ||||||
| Total liabilities and stockholders equity | $ | 404,531 | $ | 189,016 |
Sage Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 42,004 | $ | 20,376 | $ | 120,756 | $ | 69,357 | ||||||||
| General and administrative | 14,375 | 8,236 | 39,407 | 25,293 | ||||||||||||
| Total operating expenses | 56,379 | 28,612 | 160,163 | 94,650 | ||||||||||||
| Loss from operations | (56,379 | ) | (28,612 | ) | (160,163 | ) | (94,650 | ) | ||||||||
| Interest income, net | 494 | 63 | 1,211 | 178 | ||||||||||||
| Other expense, net | (16 | ) | (13 | ) | (35 | ) | (23 | ) | ||||||||
| Net loss | $ | (55,901 | ) | $ | (28,562 | ) | $ | (158,987 | ) | $ | (94,495 | ) | ||||
| Net loss per share basic and diluted | $ | (1.50 | ) | $ | (0.99 | ) | $ | (4.75 | ) | $ | (3.40 | ) | ||||
| Weighted average shares outstanding basic and diluted | 37,198,631 | 28,810,565 | 33,492,795 | 27,778,288 |