Sage Therapeutics Announces Fourth Quarter and Full Year 2018 Financial Results and Highlights Pipeline and Business Progress
Planned U.S. commercial launch of ZULRESSO™ (brexanolone) injection,
if approved, on track for
Topline data from Phase 3 trial of SAGE-217 in MDD expected in Q4 2019 or 1Q 2020
Neurology and neuropsychiatry franchises continue to progress with positive Phase 1 data
Conference call today at
“Eight years ago, Sage was founded to address the innovation void in CNS
drug development. Today we are establishing Sage as a CNS leader by
building multiple franchise opportunities - in depression, neurology and
neuropsychiatry, with the potential to treat millions of patients. Our
focused execution across these three franchises has led to a pipeline of
four clinical candidates across several indications, all using novel
mechanisms and approaches,” said
Led by ZULRESSO™ (brexanolone) injection, which has been designated
as a breakthrough therapy by the
ZULRESSO: Prescription Drug User Fee Act (PDUFA) goal date is
March 19, 2019.
If approved, Sage plans to launch ZULRESSO in the U.S. in
June 2019, following expected scheduling by the Drug Enforcement Administration(DEA), which is to occur within 90 days of approval. The Company’s commercial infrastructure build is complete and the sales organization is launch ready, pending approval and scheduling.
- If approved, Sage plans to launch ZULRESSO in the U.S. in
SAGE-217: Multiple studies are underway across the pivotal program
studying SAGE-217 as a short-course oral treatment for depression,
which includes two completed positive pivotal trials in MDD and PPD.
Based on enrollment progress in the ongoing Phase 3
placebo-controlled MOUNTAIN Study in patients with MDD, topline
results are now expected in Q4 2019 or Q1 2020.
- The MOUNTAIN Study is evaluating two weeks of 20mg or 30mg SAGE-217 treatment compared to placebo and four weeks of follow-up in approximately 450 patients with MDD.
- As a separate observational protocol, the Company will continue to follow patients from the MOUNTAIN Study after completion for up to 6 months.
Topline readouts from Phase 3 RAINFOREST and SHORELINE studies
anticipated in 2020. Additional MDD-302 Study planned.
- The RAINFOREST Study is evaluating two weeks of 30mg SAGE-217 treatment compared to placebo in patients with MDD and co-morbid insomnia.
- The SHORELINE Study will evaluate 30mg SAGE-217 open-label treatment, treatment-free intervals and as-needed retreatment for return of major depressive episodes over the course of up to a year.
Based on the positive results of the ROBIN Study in PPD and
the ongoing Breakthrough dialog with the
FDA, the SAGE-217 depression program will be expanded to generate monotherapy maintenance data through an additional study, MDD-302. This placebo-controlled trial will evaluate fixed interval SAGE-217 monotherapy (treatment without traditional antidepressants) for up to a year, and, if positive, would generate data that the Company believes will maximize value, help fulfill FDAregistration requirements, and offer more treatment options to clinicians, if SAGE-217 is successfully developed and approved.
- Sage believes that these studies will provide support for Sage’s vision to transform the treatment paradigm for MDD.
The open-label Phase 2 ARCHWAY Study is evaluating SAGE-217 as a
treatment for bipolar depression, with topline results expected in
the first half of 2019.
- The ARCHWAY Study is evaluating open-label SAGE-217 treatment in up to 30 patients with bipolar I/II disorder with a current major depressive episode. Primary endpoints are safety and tolerability; secondary endpoints will measure improvements in depressive symptoms and sleep.
- Based on enrollment progress in the ongoing Phase 3 placebo-controlled MOUNTAIN Study in patients with MDD, topline results are now expected in Q4 2019 or Q1 2020.
Led by SAGE-324, a next-generation positive allosteric modulator (PAM) of GABAA receptors in development as a potential therapy for neurological conditions, such as essential tremor and epileptiform disorders.
- SAGE-324: Results from a Phase 1 single ascending dose study demonstrated that the profile of SAGE-324 includes good oral bioavailability and a pharmacokinetic profile consistent with once-daily dosing. SAGE-324 demonstrated clear target engagement in the brain using pharmaco-EEG (β-band power) as a functional biomarker.
- SAGE-324 was generally well-tolerated with no serious adverse events and with a safety profile consistent with GABAA positive allosteric modulation.
- The Phase 1 multiple ascending dose study is ongoing and a Phase 1 study to determine the safety, tolerability and pharmacokinetics of SAGE-324 in patients with essential tremor has been initiated.
Led by first-in-class NMDA receptor PAM, SAGE-718, which is in development as a potential therapy for certain cognition-related disorders impacted by NMDA receptor dysfunction.
- SAGE-718: Results from Phase 1 studies demonstrated that the profile of SAGE-718 includes good oral bioavailability and a pharmacokinetic profile consistent with once-daily dosing.
- SAGE-718 was generally well-tolerated with no serious adverse events reported.
- Results from target engagement biomarker studies in healthy volunteers, focusing on electrophysiology and imaging, are ongoing with results expected later in 1H 2019.
- Initiated a Phase 1 study to determine the safety, tolerability and pharmacokinetics of SAGE-718 in patients with early manifest Huntington’s disease.
- Data readouts:
- SAGE-217 Phase 2 ARCHWAY Study in bipolar depression (1H 2019)
- SAGE-718 Phase 1 biomarker data (1H 2019)
- SAGE-324 Phase 1 MAD study (2H 2019)
- SAGE-324 essential tremor Phase 1 cohort data (2H 2019)
- SAGE-718 Huntington’s Disease Phase 1 cohort data (2H 2019)
- SAGE-217 MDD Phase 3 MOUNTAIN Study (Q4 2019/Q1 2020)
- SAGE-217 MDD Phase 3 RAINFOREST and SHORELINE studies (2020)
- Regulatory and commercial:
ZULRESSO in PPD PDUFA target date (
March 19, 2019)
ZULRESSO in PPD commercial launch, if approved (
- ZULRESSO in PPD PDUFA target date (
Financial Results for the Fourth Quarter and Full Year 2018
- Cash Position: Cash, cash equivalents, and marketable
securities as of
December 31, 2018were $922.8 million, compared with $518.8 millionat December 31, 2017. The increase was primarily due to net proceeds of $631.2 millionfrom Sage's follow-on public offering completed in February 2018, and an upfront milestone payment from Shionogi & Co., Ltd.related to the strategic collaboration on SAGE-217 in Japan, Taiwanand South Koreathat we entered into in June 2018.
- R&D Expenses: Research and development expenses were
$88.8 million, including $15.9 millionof non-cash stock-based compensation expense, in the fourth quarter of 2018, compared to $50.9 million, including $5.7 millionof non-cash stock-based compensation expense, for the same period of 2017. For the year ended December 31, 2018, research and development expenses were $282.1 million, including $50.9 millionof non-cash stock-based compensation expense, compared to $210.3 million, including $19.9 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 Phase 3 clinical development of SAGE-217 in PPD and MDD; the continuation of Phase 1 studies of SAGE-324 and SAGE-718 and supporting clinical activities; ongoing early-stage R&D programs and discovery efforts focused on identifying new development candidates and additional indications of interest; and investments in R&D headcount to support the growth in Sage's pipeline and operations. These expenses were offset by a decrease in expense related to the ZULRESSO clinical development program.
- G&A Expenses: General and administrative expenses
$75.7 million, including $15.8 millionof non-cash stock-based compensation expense, in the fourth quarter of 2018, compared to $19.6 million, including $4.6 millionof non-cash stock-based compensation expense, for the same period of 2017. For the year ended December 31, 2018, G&A expenses were $201.4 million, including $51.1 millionof non-cash stock-based compensation expense, compared to $62.9 million, including $15.6 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
$158.4 millionfor the fourth quarter of 2018 and $372.9 millionfor the year ended December 31, 2018, compared to a net loss of $69.4 millionand $270.1 million, respectively, for the comparable periods of 2017.
- Based upon its current operating plan, Sage now anticipates that its existing cash, cash equivalents and marketable securities, and estimated product sales of ZULRESSO, if the product is approved, will enable Sage to fund its operating expenses and capital expenditure requirements into 2H 2020.
- Sage expects that its operating expenses will increase year over year in 2019 to support continued pipeline advancement and anticipated commercialization of ZULRESSO in PPD.
Conference Call Information
Sage will host a conference call and webcast today at
About Sage Therapeutics
Various statements in this release concern Sage's future
expectations, plans and prospects, including without limitation: our
expectations regarding approval of our new drug application (NDA) for
ZULRESSO in the treatment of PPD, including the target timing of a
decision by the
|Sage Therapeutics, Inc. and Subsidiaries|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended December 31,||Year Ended December 31,|
|Research and development||88,805||50,890||282,107||210,277|
|General and administrative||75,695||19,558||201,404||62,878|
|Total operating expenses||164,500||70,448||483,511||273,155|
|Loss from operations||(164,227||)||(70,448||)||(393,238||)||(273,155||)|
|Interest income, net||5,851||1,042||20,334||3,099|
|Other income (expense), net||(12||)||(15||)||22||(64||)|
|Net loss per share - basic and diluted||$||(3.38||)||$||(1.75||)||$||(8.08||)||$||(7.09||)|
|Weighted average shares outstanding - basic and diluted||46,876,452||39,583,004||46,121,194||38,113,678|
|Sage Therapeutics, Inc. and Subsidiaries|
|Condensed Consolidated Balance Sheets|
|December 31, 2018||December 31, 2017|
|Cash and cash equivalents||$||190,943||$||306,235|
|Prepaid expenses and other current assets||21,919||6,227|
|Total current assets||944,695||525,075|
|Property and equipment and other long-term assets||8,010||4,862|
|Liabilities and Stockholders' Equity|
|Total current liabilities||86,030||51,951|
|Total stockholders' equity||862,971||475,475|
|Total liabilities and stockholders' equity||$||952,705||$||529,937|
Maureen L. Suda