OvaScience Reports Second Quarter 2017 Financial Results
– Fertilization of Bovine EggPC Cell-Derived Egg in OvaTure Program on Track for Year-End –
– Completed Target Enrollment in OvaPrime Clinical Safety Study; Expect to Announce Initial Safety Data in First 20 Patients by Year-End –
– Sufficiently Funded to Support Operations into 1Q 2020, Enabling Key Milestones –
– Conference Call Today at
Second Quarter and Recent Business Highlights:
OvaTureSM Treatment: OvaTure is a potential next-generation in vitro fertilization (IVF) treatment that could help a woman produce healthy, young, fertilizable eggs without hormone injections by maturing egg precursor (EggPCSM) cells into eggs in vitro.
Midwest Reproductive Symposium International(MRSi) in June 2017, and the 50th Annual Meeting of the Society for the Study of Reproduction(SSR) in July 2017, OvaSciencepresented pre-clinical data which it believes demonstrate that bovine and human EggPC cell-derived eggs are similar to endogenous eggs with respect to key morphologic, genetic and functional criteria indicative of developmental competence. This suggests that bovine and human EggPC cells can be developed in vitro into eggs that exhibit key hallmarks of maturation.
OvaScienceand Intrexon® (NYSE:XON) continue to progress fertilization studies for bovine EggPC-cell derived eggs. Starting in August 2017, Intrexonwill perform pre-clinical bovine EggPC work for OvaScienceunder the OvaTure collaboration rather than under the OvaXonSM joint venture. Based on project plans provided by Intrexon, OvaSciencecontinues to expect to fertilize a bovine EggPC cell-derived egg by the end of 2017 and is in discussions with Intrexonregarding the future of the OvaXon joint venture.
OvaSciencecontinues to work with its clinical partners toward its goals of developing a repeatable and robust process for the maturation of human EggPC cells. The Company is also working toward securing authorization to fertilize human EggPC cell-derived eggs and characterizing the resulting embryos by the end of the first half of 2018.
OvaPrimeSM Treatment: OvaPrime is a potential fertility treatment that could enable a woman who makes too few or no eggs to increase her egg reserve, by transferring her EggPC cells to her own ovary, where they may mature into fertilizable eggs.
June 2017, OvaScienceannounced that it has completed target enrollment of 70 patients in its ongoing prospective, controlled, blinded and randomized study of OvaPrime, which is designed to assess the treatment’s safety in women with either primary ovarian insufficiency (POI) or poor ovarian response (POR). Secondary endpoints include OvaPrime’s effect on patients’ anti-mullerian (AMH), follicle stimulating (FSH), and estradiol (E2) hormone levels, as well as follicular development, as measured by ultrasound. OvaScienceexpects to complete biopsies in 70 patients and to announce initial safety data from the first 20 patients by year-end.
AUGMENTSM Treatment: AUGMENT is a fertility treatment designed to improve egg health and with that, IVF success rates, by using mitochondria from a woman’s own EggPC cells during IVF.
June 2017, OvaScienceannounced that it will continue to pursue business development opportunities for AUGMENT, while discontinuing its ongoing operations related to the AUGMENT treatment outside of North America. The Company is committed to minimizing the impact of this decision on women and families in affected areas.
June 2017, OvaScienceannounced the appointment of Christopher Kroeger, M.D., M.B.A., as Chief Executive Officer, effective September 1, 2017. Dr. Kroeger brings substantial experience driving drug development and innovation in the life sciences and medical industries, and a strong clinical and research background as a physician and scientist. Upon Dr. Kroeger’s transition to OvaScience, Michelle Dipp, M.D., Ph.D., Co-Founder and Executive Chairman, will step down from the Board of Directors and serve in an advisory role. Richard Aldrich, Co-Founder of OvaScienceand Partner of Longwood Fund, will continue to serve as lead independent director of the Board of Directors.
June 2017, OvaScienceundertook a corporate restructuring to align with its strategic focus on advancing OvaTure and OvaPrime and to extend its cash position into the first quarter of 2020. In conjunction with this restructuring, OvaSciencereduced its workforce by approximately 50 percent.
Upcoming 2017 Milestones:
The Company expects to achieve the following milestones by year-end 2017:
- Fertilize a bovine EggPC cell-derived egg
- Complete biopsies in 70 patients in the ongoing Canadian study
- Provide initial data readout, including six months of post-EggPC reintroduction safety data from 20 patients
Second Quarter 2017 Financial Results:
Revenue for the quarter ended
June 30, 2017was $84,000, compared to $189,000for the same period in 2016.
Research and development expense for the quarter ended
June 30, 2017, excluding restructuring charges, was $5.0 million, compared to $6.0 millionfor the same period in 2016. This decrease was primarily driven by a $0.5 milliondecrease in employee related costs and stock-based compensation and a $0.5 milliondecrease in certain research agreements, both resulting from restructuring activities.
Selling, general and administrative expense for the quarter ended
June 30, 2017, excluding restructuring charges, was $10.8 million, compared to $11.2 millionfor the same period in 2016. The decrease was driven by decreases of $1.4 millionin employee related costs due to the Company’s reduced headcount, a $1.2 milliondecrease in marketing and commercial related costs, a $0.8 milliondecrease in travel, facilities and other costs primarily resulting from the Company’s restructuring activities. These decreases were offset by a $2.9 millionincrease in non-cash stock-based compensation, primarily driven by the modification of awards granted to an executive resulting in accelerated compensation expense. Of the $2.9 millionincrease, $2.3 millionrelated to the June 2014and December 2014option grants. The Advisory Agreement has subsequently been amended to permit the accelerated vesting of those grants prior to December 31, 2018only in the event of a future termination “without cause” or resignation for “good reason.”
Net loss for the quarter ended
June 30, 2017was $18.2 million, or ($0.51)per share, compared to a net loss of $18.6 million, or ($0.62)per share, for the same period in 2016. The net loss for the quarter ended June 30, 2017includes restructuring charges of $2.0 million.
This press release includes forward-looking statements about the Company’s plans for the OvaPrimeSM treatment, OvaTureSM treatment and AUGMENTSM treatment, including statements relating to the Company’s (i) belief that it is sufficiently funded, without additional financing, to support operations into the first quarter of 2020, (ii) discussions with
-- Financial Tables to Follow --
|Condensed Consolidated Balance Sheets|
|Cash and cash equivalents||$||22,937||$||43,930|
|Prepaid expenses and other current assets||2,535||2,056|
|Total current assets||89,094||116,444|
|Property and equipment, net||3,956||5,572|
|Investment in joint venture||-||65|
|Other long-term assets||23||23|
|Liabilities and stockholders’ equity|
|Accrued expenses and other current liabilities||8,544||11,026|
|Total current liabilities||11,819||13,209|
|Other non-current liabilities||925||1,116|
|Total stockholders’ equity||81,141||108,218|
|Total liabilities and stockholders’ equity||$||93,885||$||122,543|
|Condensed Consolidated Statements of Operations|
|(In thousands, except per share data)|
Three Months Ended
Six Months Ended
|Costs and expenses:|
|Costs of revenues||274||1,233||543||2,409|
|Research and development||4,997||5,987||10,761||11,942|
|Selling, general and administrative||10,751||11,210||18,371||25,664|
|Total costs and expenses||18,014||18,430||33,155||40,015|
|Loss from operations||(17,930||)||(18,241||)||(33,008||)||(39,680||)|
|Interest income, net||186||161||368||335|
|Other income, net||25||(22||)||(35||)||(49||)|
|Loss from equity method investment||(454||)||(416||)||(875||)||(807||)|
|Loss before income taxes||$||(18,173||)||$||(18,518||)||(33,550||)||$||(40,201||)|
|Income tax expense||13||50||22||125|
|Net loss per share—basic and diluted||$||(0.51||)||$||(0.62||)||$||(0.94||)||$||(1.41||)|
|Weighted average number of shares used in net loss per share—basic and diluted||35,664||30,036||35,653||28,668|
Media and Investor Contact
Jennifer Viera, 617-420-8728