Sage Therapeutics, Inc.
Feb 23, 2017

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.--(BUSINESS WIRE)-- 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

Pipeline Update

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
Various 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.

         
Sage Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
 
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)
(unaudited)
               
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  
 

Investor Contact:
Sage Therapeutics
Paul Cox, 617-299-8377
paul.cox@sagerx.com
or
Media Contact:
Suda Communications LLC
Maureen L. Suda, 585-387-9248
maureen.suda@sagerx.com

Source: Sage Therapeutics, Inc.

News Provided by Acquire Media