08/06/2019 | Press release | Archived content
ZULRESSO™ (brexanolone) injection CIV, the first treatment specifically indicated for postpartum depression, commercially launched in the U.S. in late-June, with first patients treated in July 2019
Commercial execution is progressing as expected and on-track across key focus areas including enabling pathways to care, facilitating patient access in the treatment of PPD, and supporting women through Sage Central
Strong data signals from depression, neurology and neuropsych franchises presented at FutureCast
Conference call today at 8:00 a.m. EDT
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 6, 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 second quarter ended June 30, 2019.
"Eight years ago, Sage laid the foundation to become the leading brain health company during a time when there was tremendous skepticism about the ability to develop novel medicines," said Jeff Jonas, M.D., chief executive officer at Sage. "Today, our first compound is now our first commercially launched drug and our track record of success is a direct result of our unique approach to R&D and clinical development programs. Sage's deliberate decision-making approach around pipeline management has allowed us to build what I think is a leading multi-franchise company focused on getting patients better, sooner."
Portfolio Updates:
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:
Led by ZULRESSO™ (brexanolone) injection CIV, approved by the U.S. Food and Drug Administration (FDA) in March 2019 as the first treatment specifically indicated for postpartum depression (PPD), and 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. SAGE-217 has received breakthrough therapy designation from the U.S. FDA for the treatment of major depressive disorder (MDD).
Neurology Franchise:
SAGE-324, a next-generation PAM of GABAA receptors, is in development as a potential therapy for neurological conditions, such as essential tremor (ET), epilepsy and Parkinson's disease.
Neuropsychiatry Franchise:
SAGE-718, a first-in-class NMDA receptor PAM, is in development as a potential therapy for cognitive disorders associated with NMDA receptor dysfunction.
Anticipated Upcoming Milestones
Financial Results for the Second Quarter of 2019
Financial Guidance
Conference Call Information
Sage will host a conference call and webcast today at 8:00 a.m. EDT to discuss its second 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, including the potential timing of availability of sites capable of administering ZULRESSO, the potential timing of revenue momentum and the potential for 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 earlier stage 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; 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) | ||||||||||||
(unaudited) | ||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||
Product revenue, net |
$ |
519 |
$ |
- |
$ |
519 |
$ |
- |
||||
Collaboration revenue |
354 |
90,000 |
819 |
90,000 |
||||||||
Total revenue |
873 |
90,000 |
1,338 |
90,000 |
||||||||
Operating costs and expenses: | ||||||||||||
Cost of goods sold |
44 |
- |
44 |
- |
||||||||
Research and development |
89,059 |
68,980 |
175,457 |
118,250 |
||||||||
Selling, general and administrative |
88,227 |
43,167 |
172,146 |
72,016 |
||||||||
Total operating costs and expenses |
177,330 |
112,147 |
347,647 |
190,266 |
||||||||
Loss from operations |
(176,457) |
(22,147) |
(346,309) |
(100,266) |
||||||||
Interest income, net |
8,220 |
5,137 |
14,662 |
8,666 |
||||||||
Other income, net |
16 |
32 |
20 |
24 |
||||||||
Net loss |
$ |
(168,221) |
$ |
(16,978) |
$ |
(331,627) |
$ |
(91,576) |
||||
Net loss per share - basic and diluted |
$ |
(3.28) |
$ |
(0.36) |
$ |
(6.65) |
$ |
(2.02) |
||||
Weighted average shares outstanding - basic and diluted |
51,257,640 |
46,541,716 |
49,882,377 |
45,439,666 |
Sage Therapeutics, Inc. and Subsidiaries | |||||||
Condensed Consolidated Balance Sheets | |||||||
(in thousands) | |||||||
(unaudited) | |||||||
June 30, 2019 |
December 31, 2018 |
||||||
Cash, cash equivalents, restricted cash and investments |
$ |
1,238,916 |
$ |
925,143 |
|||
Total assets |
$ |
1,315,547 |
$ |
952,705 |
|||
Total liabilities |
$ |
112,672 |
$ |
89,734 |
|||
Total stockholders' equity |
$ |
1,202,875 |
$ |
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.
What is ZULRESSO?
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:
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 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?
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?
Tell your 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.
Call your 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190806005258/en/
Source: Sage Therapeutics
Investor Contact:
Maren Killackey, 617-949-4113
maren.killackey@sagerx.com
Media Contact:
Alexis Smith, 617-588-3740
alexis.smith@sagerx.com