Sage Therapeutics Announces First Quarter 2018 Financial Results and Provides Update on Pipeline and Progress toward Launch Readiness
New Drug Application for intravenous (IV) formulation of brexanolone
as a treatment for postpartum depression submitted to
Significant progress achieved in launch readiness preparations in anticipation of potential 1H 2019 brexanolone IV launch
Broad pipeline of drug candidates to treat central nervous system disorders continues to advance, with at least 7 clinical trial programs expected to be ongoing in 2018
Conference call today at
“At Sage, we are focused on improving patient care through innovation.
In the first half of 2018, we made great progress toward achieving that
mission by accelerating launch preparation activities and R&D efforts
across our portfolio,” said
Launch Readiness Updates:
Sage has made significant recent progress in preparing for a potential
1H 2019 commercial launch of brexanolone IV for the treatment of PPD,
if the NDA is approved, including:
Expanding the commercial organization, including the addition of
senior leaders across Marketing, Sales, Market Access and
Patient Support Services; initiating the field team build with the addition of the national sales directors, and national and regional payer account directors;
- Advancing our strategy to deliver a family-centric support model with varied potential site of care options for patients with PPD, including progressing work towards the development of a national network intended to support home infusion;
Creating a robust patient support model, including plans for
in-house case management support, with headquarters expected to be
North Carolina; and
- Engaging in permitted discussions with payers to raise awareness of PPD and on the value proposition of the brexanolone IV product profile.
- Expanding the commercial organization, including the addition of senior leaders across Marketing, Sales, Market Access and
Sage is advancing a portfolio of novel 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 developing its proprietary IV formulation of brexanolone and a pipeline of novel, next-generation, positive allosteric GABA modulators, including SAGE-217 and SAGE-324.
Brexanolone IV in Postpartum Depression (PPD):
Sage recently submitted an NDA to the
U.S. Food and Drug Administration( FDA) for brexanolone for the treatment of PPD. Sage is preparing for a potential commercial launch of brexanolone IV in PPD in the U.S. in the first half of 2019, if the product is approved by the FDA.
Sage presented detailed clinical results from Phase 2 and Phase 3
programs of brexanolone IV in PPD at the
North American Society for Psychosocial Obstetrics and Gynecology(NASPOG) and American College of Obstetricians and Gynecologists(ACOG) 2018 annual meetings. Sage plans to also present these study results at upcoming medical meetings and through publication.
- Sage recently submitted an NDA to the
SAGE-217 in Major Depressive Disorder (MDD), Bipolar Depression, and
Earlier this year, the
FDAgranted Breakthrough Therapy designation to SAGE-217 for the treatment of MDD, offering the potential for an expedited development path that may include increased interaction and guidance from the agency. Sage anticipates meeting with the FDAto discuss the design of additional clinical trials of SAGE-217 in depression. Sage expects to initiate further MDD trials in 2018.
- Sage plans to further explore SAGE-217 as a potential treatment in sleep disorders with a Phase 2 clinical trial expected to begin later this year.
- Earlier this year, the
SAGE-217 in PPD:
- Sage is currently conducting a multi-center, double-blind, placebo-controlled, randomized Phase 2 clinical trial of SAGE-217 in 140 patients with PPD and expects to report top-line results in 4Q 2018.
SAGE-217 in Parkinson’s Disease:
- Sage plans to initiate a randomized, placebo-controlled Phase 2 clinical trial in Parkinson’s disease patients with residual tremor in 2H 2018.
- Sage expects to initiate a Phase 1 single-ascending dose study of SAGE-324 in 3Q 2018. SAGE-324 is being developed as a potential treatment for chronic conditions involving GABA hypofunction, such as essential tremor and epileptiform disorders.
GABA Discovery Programs:
- Sage is currently evaluating a series of novel GABAA receptor modulators in pre-clinical development, including SAGE-689, SAGE-105 and others.
Sage is developing novel, oral, first-in-class oxysterol-based positive allosteric modulators of the NMDA receptor, which may have potential in the treatment of a range of neurological disorders associated with a variety of cognitive, neurological and behavioral symptoms.
- Given the pharmacokinetics of SAGE-718 observed in a Phase 1 single ascending dose study, Sage expects to further evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of the compound in a Phase 1 multiple ascending dose trial in healthy volunteers that is expected to start in 2Q 2018.
- If the Phase 1 program is successful, Sage plans to advance SAGE-718 into clinical trials of certain CNS disorders characterized by NMDA receptor hypofunction.
- SAGE-904, Sage’s second NMDA positive allosteric modulator candidate, is currently in IND-enabling studies.
Disease Education Initiatives:
Sage has advanced a variety of efforts to increase awareness of PPD
and the need for screening, through initiatives led by Sage’s Medical
- Establishing support of digital and live medical education programs on screening and current management of PPD;
- Conducting ongoing broad multi-channel disease awareness efforts via digital women’s health apps, web-based adaptive education, and advocacy partnerships to reduce stigma of PPD and help patients and families discuss symptoms of PPD with healthcare providers; and
- Initiating ongoing collaborations on educational initiatives with top academic societies, including ACOG.
- Medical Meeting Presentations:
American Psychiatric Association(APA) 2018 Annual Meeting, May 5– May 9, 2018in New York, NY Society of Biological Psychiatry(SOBP) 73rd Annual Meeting, May 10– May 12, 2018in New York, NY International Society for Pharmacoeconomics and Outcomes Research(ISPOR) 2018 Annual International Meeting, May 19– May 23, 2018in Baltimore, MD American Society of Clinical Psychopharmacology(ASCP) 2018 Annual Meeting, May 29– June 1, 2018in Miami, FL Postpartum Support International(PSI) Annual Conference, July 13– July 15, 2018in Houston, TX
- Trial Initiations:
- Phase 1 multiple ascending dose trial for SAGE-718 (2Q 2018)
- Phase 1 single ascending dose trial for SAGE-324 (3Q 2018)
- Phase 2 clinical trial for SAGE-217 in Parkinson’s disease (2H 2018)
- SAGE-217 programs in MDD, bipolar depression, and sleep disorders (2018)
- Data Readouts:
- Results from Phase 2 trial of SAGE-217 in PPD (4Q 2018)
- Results from Phase 1 multiple ascending dose trial for SAGE-718 (2H 2018)
- Results from clinical trials of SAGE-217 in MDD, bipolar disorder, Parkinson’s disease and sleep disorders expected to be initiated in 2018 (2019)
- Regulatory and Commercial:
- Acceptance of NDA filing submission in U.S. for brexanolone IV in PPD (2Q 2018)
- EMA Scientific Advice for brexanolone IV in PPD (2H 2018)
- Brexanolone IV commercial launch in PPD, if approved (1H 2019)
Financial Results for the First Quarter of 2018
“We continue to be very strategic in the investments we make across the
organization to ensure our ability to maximize the potential of our
development-stage and pre-commercial assets,” said
- Cash Position: Cash, cash equivalents, and marketable
securities as of
March 31, 2018were $1.1 billion, compared with $518.8 millionat December 31, 2017. The increase was primarily due to net proceeds of $632.2 millionfrom Sage's follow-on public offering completed in February 2018.
- R&D Expenses: Research and development expenses were
$49.3 million, including $8.9 millionof non-cash stock-based compensation expense, in the first quarter of 2018, compared to $45.2 million, including $3.6 millionof non-cash stock-based compensation expense, for the same period of 2017. The increase in R&D expenses year-over-year was primarily due to increases in ongoing R&D programs and discovery efforts focused on identifying new clinical candidates and additional indications of interest and investments in R&D headcount to support the growth in Sage's pipeline and operations, offset by decreases in expenses due to the completion of Phase 3 clinical development of brexanolone IV, and completion of certain Phase 2 clinical trials of SAGE-217.
- G&A Expenses: General and administrative expenses were
$28.8 million, including $6.9 millionof non-cash stock-based compensation expense, in the first quarter of 2018, compared to $12.3 million, including $2.6 millionof non-cash stock-based compensation expense, for the same period of 2017. The increase in G&A expenses was primarily due to the increase in personnel-related expenses, professional fees to support expanding operations, costs related to continued preparations for a potential commercial launch, and facilities-related costs to support expanding operations.
- Net Loss: Net loss was
$74.6 millionfor the first quarter of 2018 compared to a net loss of $56.8 million, for the comparable period of 2017.
- Based on its current operating plan, Sage anticipates that its existing cash, cash equivalents and marketable securities will enable Sage to fund its operating expenses and capital expenditure requirements into 2020.
- Sage expects that its operating expenses will increase year over year in 2018 to support continued pipeline advancement and preparations for potential commercialization of brexanolone IV in PPD, if approved.
Conference Call Information
Sage will host a conference call and webcast today at
Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation: our expectations regarding acceptance by the
|Sage Therapeutics, Inc. and Subsidiaries|
|Condensed Consolidated Balance Sheets|
|March 31, 2018||December 31, 2017|
|Cash and cash equivalents||$||557,555||$||306,235|
|Prepaid expenses and other current assets||11,575||6,227|
|Total current assets||1,095,088||525,075|
|Property and equipment and other long-term assets||5,564||4,862|
|Liabilities and Stockholders' Equity|
|Total current liabilities||37,872||51,951|
|Total stockholders' equity||1,059,276||475,475|
|Total liabilities and stockholders' equity||$||1,100,652||$||529,937|
|Sage Therapeutics, Inc. and Subsidiaries|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended March 31,|
|Research and development||$||49,270||$||45,200|
|General and administrative||28,849||12,280|
|Total operating expenses||78,119||57,480|
|Loss from operations||(78,119||)||(57,480||)|
|Interest income, net||3,529||707|
|Other expense, net||(8||)||(5||)|
|Net loss per share - basic and diluted||$||(1.68||)||$||(1.52||)|
|Weighted average shares outstanding - basic and diluted||44,325,371||37,269,148|