- Brexanolone IV in Postpartum Depression (PPD):
- Following a pre-NDA meeting with the U.S. Food and Drug Administration (FDA), Sage remains on track to file a New Drug Application (NDA) with the FDA in 1H 2018.
- Sage anticipates presenting detailed study results from the Phase 3 program of brexanolone IV in PPD at upcoming medical meetings and through publication.
- SAGE-217 in Major Depressive Disorder (MDD):
- The FDA recently granted Breakthrough Therapy designation to SAGE-217 for the treatment of MDD based on the positive results from the Phase 2, placebo-controlled trial of SAGE-217 in 89 adult patients with moderate to severe MDD.
- Sage plans to initiate additional clinical trials of SAGE-217 in MDD in 2018.
- SAGE-217 in Postpartum Depression:
- Sage is currently conducting a multi-center, double-blind, placebo-controlled, randomized Phase 2 clinical trial of SAGE-217 in severe PPD.
- Sage believes the positive Phase 2 trial of SAGE-217 in MDD and positive Phase 3 trials of brexanolone in PPD support maximizing the utility of the ongoing Phase 2 trial of SAGE-217 in PPD. Sage increased the size of the ongoing trial and expects top-line results in 4Q 2018.
- SAGE-217 in Bipolar Depression, Parkinson's Disease and Insomnia:
- Sage plans to initiate clinical development of SAGE-217 in bipolar depression and continue further clinical development of SAGE-217 in Parkinson's disease and disorders of sleep in 2018. Sage believes that available data from studies of MDD, Parkinson's disease and a healthy volunteer insomnia model support further exploration in these indications.
- SAGE-324 is currently in IND-enabling studies and is intended to be developed with a focus on indications involving GABA hypofunction, such as essential tremor and epileptiform disorders.
- Sage expects to initiate a Phase 1 trial of SAGE-324 in 1H 2018.
- GABA Discovery Programs:
- Sage is currently evaluating a series of novel GABA A receptor modulators in pre-clinical development, including SAGE-689, SAGE-105, and others.
- Sage previously announced it completed a Phase 1 single-ascending dose study of SAGE-718 in healthy volunteers. SAGE-718 was generally well-tolerated with no severe adverse events. The pharmacokinetics of SAGE-718 were highly predictable with low variability.
- Sage expects to initiate a Phase 1 multiple ascending dose program of SAGE-718 in 1H 2018.
- Sage recently announced it selected SAGE-904 as its second NMDA receptor positive allosteric modulator product candidate for development. SAGE-904 has a differentiated pharmacologic and pharmacokinetic profile from SAGE-718.
- SAGE-904 is currently in IND-enabling studies.
- Trial Initiations:
- Phase 1 program for SAGE-324 (1H 2018)
- Phase 1 multiple ascending dose program of SAGE-718 (1H 2018)
- Trials of SAGE-217 in MDD, bipolar depression, Parkinson's disease, and sleep disorders (2018)
- Data Readouts:
- Results from Phase 1 multiple ascending dose program of SAGE-718 (2H 2018)
- Results from recently expanded Phase 2 trial of SAGE-217 in PPD (4Q 2018)
- Results from trials of SAGE-217 in MDD, bipolar depression, Parkinson's disease, and sleep disorders (2018-2019)
- Regulatory and Commercial:
- NDA filing in U.S. for brexanolone in PPD (1H 2018)
- Brexanolone commercial launch in PPD, if approved (1H 2019)
- Cash Position: Cash, cash equivalents, and marketable securities as of December 31, 2017 were $518.8 million, compared with $397.5 million at December 31, 2016. The increase was primarily due to net proceeds of $325.8 million from Sage's follow-on public offering completed in November 2017. In February 2018, Sage completed an underwritten public offering, which included the full exercise of the underwriters' option to purchase additional shares, resulting in net proceeds of approximately $631.1 million.
- R&D Expenses: Research and development expenses were $50.9 million, including $5.7 million of non-cash stock-based compensation expense, in the fourth quarter of 2017, compared to $42.0 million, including $5.0 million of non-cash stock-based compensation expense, for the same period of 2016. For the year ended December 31, 2017, research and development expenses were $210.3 million, including $19.9 million of non-cash stock-based compensation expense, compared to $120.8 million, including $11.2 million of non-cash stock-based compensation expense, for the same period of 2016. The increase in R&D expenses year-over-year was primarily due to Phase 3 clinical development of brexanolone and CMC work in preparation for a potential filing for regulatory approval; the ongoing Phase 2 development of SAGE-217; 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.
- G&A Expenses: General and administrative expenses were $19.6 million, including $4.6 million of non-cash stock-based compensation expense, in the fourth quarter of 2017, compared to $14.4 million, including $5.1 million of non-cash stock-based compensation expense, for the same period of 2016. For the year ended December 31, 2017, G&A expenses were $62.9 million, including $15.6 million of non-cash stock-based compensation expense, compared to $39.4 million, including $11.8 million of non-cash stock-based compensation expense, for the same period of 2016. 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 $69.4 million for the fourth quarter of 2017 and $270.1 million for the year ended December 31, 2017, compared to a net loss of $55.9 million and $159.0 million, respectively, for the comparable periods of 2016.
- Based upon its current operating plan, Sage anticipates that its existing cash, cash equivalents and marketable securities, and estimated brexanolone product sales, if the product is approved, will enable Sage to fund its operating expenses and capital expenditure requirements into 2020.
- Sage expects that its operating expenses will increase year over year in 2018 to support continued pipeline advancement and potential product commercialization of brexanolone in PPD.
|Sage Therapeutics, Inc. and Subsidiaries Condensed Consolidated Balance Sheets(in thousands) (Unaudited)|
|December 31, 2017||December 31, 2016|
|Cash and cash equivalents||$||306,235||$||168,517|
|Prepaid expenses and other current assets||6,227||5,100|
|Total current assets||525,075||402,579|
|Property and equipment and other long-term assets||4,862||1,952|
|Liabilities and Stockholders' Equity|
|Total current liabilities||51,951||35,169|
|Total stockholders' equity||475,475||368,517|
|Total liabilities and stockholders' equity||$||529,937||$||404,531|
|Sage Therapeutics, Inc. and Subsidiaries Condensed Consolidated Statements of Operations(in thousands, except share and per share data) (Unaudited)|
|Three Months Ended December 31,||Year Ended December 31,|
|Research and development||$||50,890||$||42,004||$||210,277||$||120,756|
|General and administrative||19,558||14,375||62,878||39,407|
|Total operating expenses||70,448||56,379||273,155||160,163|
|Loss from operations||(70,448||)||(56,379||)||(273,155||)||(160,163||)|
|Interest income, net||1,042||494||3,099||1,211|
|Other expense, net||(15||)||(16||)||(64||)||(35||)|
|Net loss per share - basic and diluted||$||(1.75||)||$||(1.50||)||$||(7.09||)||$||(4.75||)|
|Weighted average shares outstanding - basic and diluted||39,583,004||37,198,631||38,113,678||33,492,795|