Full Press Release Details
Sage Therapeutics Announces Fourth Quarter and Full Year 2019 Financial Results and Highlights Pipeline and Business Progress
ZULRESSO (brexanolone) CIV injection net revenues of $2M and $4M for fourth
quarter and full year 2019, respectively
Evaluating path forward for the zuranolone
(SAGE-217) Landscape Program
Continued expansion of Neurology and Neuropsychiatry
franchises with planned initiation of additional SAGE-324 and SAGE-718 studies in 2020
Conference call today at 8:00 a.m. EST
CAMBRIDGE, Mass. Feb. 27, 2020 Today, Sage Therapeutics, Inc. (NASDAQ: SAGE), a biopharmaceutical company committed to developing novel
therapies with the potential to transform the lives of people with debilitating disorders of the brain, reported business highlights and financial results for the fourth quarter and full year ended December 31, 2019.
The progress we made in 2019 across our depression, neuropsych and neurology franchises supports our vision to make medicines that matter, said
Jeff Jonas, chief executive officer of Sage Therapeutics. Our focus in 2020 will be guided by perseverance, disciplined execution, and rigorous prioritization designed to achieve an optimal pace of innovation for what we believe is a leading,
novel portfolio of NCEs dedicated to treating brain health disorders. Our most immediate goal is to find the most efficient pathway to bring new treatments to patients as quickly as possible.
Sage is advancing a portfolio
of novel and differentiated product candidates designed to improve brain health by targeting the GABA and NMDA receptor systems. Dysfunction in these systems is thought to be at the core of numerous neurological and neuropsychiatric disorders.
Depression Franchise
The Depression Franchise
is led by ZULRESSO (brexanolone) CIV injection, approved by the U.S. Food and Drug Administration (FDA) as the first treatment specifically indicated for postpartum depression (PPD), and
zuranolone (SAGE-217), Sage s next-generation positive allosteric modulator (PAM) of GABAA receptors, being evaluated in clinical development as a
treatment for various affective disorders. Zuranolone has received breakthrough therapy designation from the FDA for the treatment of major depressive disorder (MDD).
SAGE-324, a next-generation PAM of GABAA receptors and
Sage s lead neurology asset, is in development as a potential oral therapy for neurological conditions, such as essential tremor (ET), epilepsy and Parkinson s disease.
Neuropsychiatry Franchise
SAGE-718, Sage s first-in-class NMDA receptor PAM and lead neuropsychiatric drug candidate, is in development as a potential oral
therapy for cognitive disorders associated with NMDA receptor dysfunction, including Huntington s disease (HD).
Anticipated Upcoming Milestones
Financial Results for the Fourth Quarter and Full Year 2019
Conference Call Information
Sage will host a conference call and webcast today, Thursday, February 27, 2020, at 8:00 a.m. EST to discuss its fourth quarter and full year
2019 financial results and 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 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 biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with
debilitating disorders of the brain. We are pursuing new pathways with the goal of improving brain health, and our depression, neurology and neuropsychiatry franchise programs aim to change how brain disorders are thought about and treated. Our
mission is to make medicines that matter so people can get better, sooner. 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 views and expectations
regarding our commercial launch of ZULRESSO and its long-term potential, including the potential timing for sites to become ready to administer ZULRESSO and expectations regarding an increase in the number of activated sites, the potential timing of
revenue growth, an increase in the volume of treated patients at existing sites, and the potential for favorable reimbursement of ZULRESSO; our development plans, goals and strategy and the potential timing and results of our development efforts;
our plans to determine next steps with respect to the development and regulatory path forward for zuranolone and the Landscape Program, including any potential amendments to our clinical trials of zuranolone; our belief in the potential of our
product candidates in various indications; the potential profile and benefit of our product candidates; and the goals, opportunity and potential 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: we may encounter issues or other challenges in commercializing ZULRESSO, including issues related to market acceptance
by healthcare providers, healthcare settings and women with PPD, issues related to the willingness of sites to administer ZULRESSO, issues related to reimbursement, issues related to the requirements of the REMS, and challenges associated with
execution of our sales and patient support activities, which in each case could limit the potential of ZULRESSO and the timing and amount of future revenues; results achieved with use of ZULRESSO in the treatment of PPD in commercial use may be
different than observed in clinical trials, and may vary among patients; the number of women with PPD or the unmet need for additional treatment options may be significantly smaller than we expect; we may encounter unexpected safety or tolerability
issues with ZULRESSO or any of our product candidates, including, for zuranolone or other product candidates, as a result of any increase in dosing in our clinical trials; we may not be successful in our development of any of our current or future
product candidates in any indication we are currently pursuing or may in the future pursue; success in prior clinical trials or nonclinical studies may not be repeated or observed in ongoing or future studies of any of our product candidates;
ongoing and future clinical or nonclinical results for our product candidates may generate results that are different than we expect or may not support further development of the product candidate or be sufficient to gain regulatory approval of our
product candidates on the timelines we expect or at all, or may require additional clinical trials or nonclinical studies; 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; the FDA may decide that the development program for any of our product candidates, even if positive, is not sufficient for a new drug application filing or approval; 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 initiation or enrollment in ongoing or
future clinical trials; the internal and external costs required for our ongoing and planned research and development efforts, and to manage our organization in connection with such activities, and the resulting expense increases and use of cash,
may be higher than expected which may cause us to change or curtail some of our plans; we may
change our plans for other business reasons; and we may encounter technical and other unexpected hurdles in the development of our product candidates; as well as those risks more fully discussed
in the section entitled Risk Factors in our most recent annual report filed with the Securities and Exchange Commission (SEC), and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with
the SEC. 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
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, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Product revenue, net | $ | 1,960 | $ | $ | 3,957 | $ | ||||||||||
| Collaboration revenue | 273 | 2,911 | 90,273 | |||||||||||||
| Total revenue | 1,960 | 273 | 6,868 | 90,273 | ||||||||||||
| Operating costs and expenses: | ||||||||||||||||
| Cost of goods sold | 219 | 400 | ||||||||||||||
| Research and development | 91,250 | 88,805 | 368,815 | 282,107 | ||||||||||||
| Selling, general and administrative | 85,129 | 75,695 | 345,777 | 201,404 | ||||||||||||
| Total operating costs and expenses | 176,598 | 164,500 | 714,992 | 483,511 | ||||||||||||
| Loss from operations | (174,638 | ) | (164,227 | ) | (708,124 | ) | (393,238 | ) | ||||||||
| Interest income, net | 5,915 | 5,851 | 27,804 | 20,334 | ||||||||||||
| Other income (expense), net | 70 | (12 | ) | 82 | 22 | |||||||||||
| Net loss | $ | (168,653 | ) | $ | (158,388 | ) | $ | (680,238 | ) | $ | (372,882 | ) | ||||
| Net loss per share basic and diluted | $ | (3.25 | ) | $ | (3.38 | ) | $ | (13.38 | ) | $ | (8.08 | ) | ||||
| Weighted average shares outstanding basic and diluted | 51,834,880 | 46,876,452 | 50,833,837 | 46,121,194 |
Sage Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
| December 31, 2019 | December 31, 2018 | |||||||
| Cash, cash equivalents, restricted cash and investments | $ | 1,010,760 | $ | 925,143 | ||||
| Total assets | $ | 1,084,150 | $ | 952,705 | ||||
| Total liabilities | $ | 139,495 | $ | 89,734 | ||||
| Total stockholders equity | $ | 944,655 | $ | 862,971 |
About ZULRESSO (brexanolone) CIV injection
ZULRESSO, the first medicine specifically approved by the U.S. Food and Drug Administration (FDA) for the treatment of postpartum depression (PPD) in adults,
is a positive allosteric modulator of both synaptic and extrasynaptic GABAA receptors. Allosteric modulation of neurotransmitter receptor activity results in varying degrees of desired activity rather than complete activation or inhibition of the
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ZULRESSO?
ZULRESSO can cause serious side effects, including:
Before receiving ZULRESSO, tell your healthcare provider
about all your medical conditions, including if you:
Tell your healthcare
provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
ZULRESSO and some medicines may interact with each other and cause serious side effects.
Especially tell your healthcare provider if you take other antidepressants, opioids, or Central Nervous System (CNS) depressants (such as
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Your
healthcare provider will decide if other medicines can be taken with ZULRESSO.
How will I receive ZULRESSO?
ZULRESSO is given to you by continuous intravenous (IV) infusion into your vein. The infusion will last for a total of 60 hours (2.5 days).
What should I avoid while receiving ZULRESSO?
What are the possible side effects of ZULRESSO?
ZULRESSO can cause serious side effects, including:
How can I watch for and try to prevent suicidal thoughts and actions?
healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:
The most common side effects of ZULRESSO include:
These are not all the side effects of ZULRESSO.
doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see Full Prescribing Information including Boxed Warning and Medication Guide for ZULRESSO and discuss any questions you
may have with your healthcare provider.