Full Press Release Details
Sage Therapeutics Announces Third Quarter 2019 Financial Results and Highlights
Pipeline and Business Progress
ZULRESSO (brexanolone) CIV injection revenues of $1.5M in third quarter
Enrollment completed in SAGE-217 Phase 3 MOUNTAIN and SHORELINE studies with topline
data expected in 4Q 2019 and 2020, respectively
Planning to expand pipeline with two new GABA and NMDA clinical-stage assets
Conference call today at 8:00 a.m. EST
CAMBRIDGE, Mass., November 12, 2019 Today, Sage Therapeutics (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 third quarter ended September 30, 2019.
Sage s approach to drug discovery and development has led to the significant progress we have made during the third quarter, said Jeff Jonas,
M.D., chief executive officer of Sage Therapeutics. We are pleased with the execution by our teams at Sage. Our Depression Franchise continues to advance, our SAGE-217 studies are progressing well, and
the launch of ZULRESSO in postpartum depression is yet another step towards upending conventional wisdom about treating psychiatric disorders. On top of this, our early stage pipeline continues to expand. We are looking forward to the upcoming data
readout for SAGE-217, and we are excited by the possibilities in front of us.
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.
Sage s Depression Franchise includes ZULRESSO (brexanolone) CIV
injection, the first treatment specifically approved by the U.S. Food and Drug Administration (FDA) for postpartum depression (PPD), and SAGE-217, Sage s investigational oral neuroactive steroid
GABAA receptor positive allosteric modulator (PAM), that is being evaluated as a treatment for various affective disorders. SAGE-217 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. SAGE-718 represents a new and complementary set of opportunities for the Sage portfolio.
Anticipated Upcoming Milestones
Financial Results for the Third Quarter of 2019
Conference Call Information
Sage will host a conference call and webcast today, Tuesday, November 12, 2019, at 8:00 a.m. EST to discuss its third quarter 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 momentum 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 belief in the potential of our product candidates in various
indications; the potential profile and benefit of our product candidates; the goals, opportunity and potential for our business; and our expectations regarding our cash position at year-end and increases in
operating expense. 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; 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 may generate results that are different than we expect or 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; 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; we may encounter unexpected safety or tolerability issues with our product candidates; the internal and external costs required for
our ongoing and planned research and development efforts, and to build 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 quarterly 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 statements.
Sage Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Product revenue, net | $ | 1,478 | $ | $ | 1,997 | $ | ||||||||||
| Collaboration revenue | 2,092 | 2,911 | 90,000 | |||||||||||||
| Total revenue | 3,570 | 4,908 | 90,000 | |||||||||||||
| Operating costs and expenses: | ||||||||||||||||
| Cost of goods sold | 137 | 181 | ||||||||||||||
| Research and development | 102,108 | 75,052 | 277,565 | 193,302 | ||||||||||||
| Selling, general and administrative | 88,502 | 53,693 | 260,648 | 125,709 | ||||||||||||
| Total operating costs and expenses | 190,747 | 128,745 | 538,394 | 319,011 | ||||||||||||
| Loss from operations | (187,177 | ) | (128,745 | ) | (533,486 | ) | (229,011 | ) | ||||||||
| Interest income, net | 7,227 | 5,817 | 21,889 | 14,483 | ||||||||||||
| Other income (expense), net | (8 | ) | 10 | 12 | 34 | |||||||||||
| Net loss | $ | (179,958 | ) | $ | (122,918 | ) | $ | (511,585 | ) | $ | (214,494 | ) | ||||
| Net loss per share - basic and diluted | $ | (3.48 | ) | $ | (2.63 | ) | $ | (10.13 | ) | $ | (4.68 | ) | ||||
| Weighted average shares outstanding - basic and diluted | 51,704,687 | 46,706,770 | 50,496,489 | 45,866,676 |
Sage Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
| September 30, 2019 | December 31, 2018 | |||||||
| Cash, cash equivalents, restricted cash and investments | $ | 1,124,617 | $ | 925,143 | ||||
| Total assets | $ | 1,203,727 | $ | 952,705 | ||||
| Total liabilities | $ | 122,656 | $ | 89,734 | ||||
| Total stockholders equity | $ | 1,081,071 | $ | 862,971 |
About ZULRESSO (brexanolone) injection CIV
ZULRESSO, the first medicine specifically approved by the U.S. Food and Drug Administration (FDA) for the treatment of postpartum depression (PDD) 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 receptor.
ZULRESSO (brexanolone) CIV is a prescription medicine used in adults to treat a certain type of
depression called Postpartum Depression.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ZULRESSO?
ZULRESSO can cause serious side effects, including:
Excessive sedation and sudden loss of consciousness. ZULRESSO may cause you to feel very sleepy (excessive sedation) or pass out (loss of consciousness).
Your healthcare provider should check you for symptoms of excessive sleepiness every 2 hours while you are awake.
During your ZULRESSO infusion, tell
your healthcare provider right away if you feel like you cannot stay awake during the time you are normally awake or if you feel like you are going to pass out. Your healthcare provider may lower your dose or stop the infusion until symptoms go
You must have a caregiver or family member with you to help care for your child(ren) during your ZULRESSO infusion.
Because of the risk of serious harm resulting from excessive sedation or sudden loss of consciousness, ZULRESSO is only available through a restricted program
called the ZULRESSO REMS.
Before receiving ZULRESSO, tell your healthcare provider about all your medical conditions, including if you:
have kidney problems
are pregnant or think you may be pregnant. It is not known if ZULRESSO will harm your unborn baby.
There is a pregnancy registry for females who are exposed to ZULRESSO during pregnancy. The purpose of the registry is to collect information about the health
of females exposed to ZULRESSO and their baby. If you become pregnant during treatment with ZULRESSO, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or
visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/ are breastfeeding or plan to breastfeed.
ZULRESSO passes into breast milk. Talk to your healthcare provider about the risks and benefits of breastfeeding and about the best way to feed your baby while receiving ZULRESSO.
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 benzodiazepines).
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?
make you feel dizzy and sleepy. Do not drive a car or do other dangerous activities after your ZULRESSO infusion until your feeling of sleepiness has completely gone away. See What is the most important information I should know about
Do not drink alcohol while receiving ZULRESSO.
What are the possible side effects of ZULRESSO?
cause serious side effects, including: