OvaScience Reports Fourth Quarter and Year End 2014 Financial Results
“This past year was transformational for
2014 and Recent Highlights
Launched the AUGMENTSM Fertility Treatment
in Select International IVF Clinics
Offered the AUGMENT treatment to select international IVF clinics (see www.augmenttreatment.com).
OvaScienceanticipates expanding the availability of the AUGMENT treatment and expects 1,000 AUGMENT treatment cycles will be in process by the end of 2015. The Company set this target to ensure that it is building a high quality and scalable operating process to support OvaScience’s future fertility treatments.
The AUGMENT treatment is specifically designed to improve egg health by using mitochondria from a patient’s own egg precursor (EggPCSM) cells during IVF. Improved egg health is essential for fertilization and embryo development. The AUGMENT treatment is not available in
the United States.
Completed Preclinical Work that Supports Introduction of the
OvaPrimeSM Treatment in Patients by the End
Reported additional, preclinical proof-of-concept work ahead of a planned introduction of the OvaPrime treatment outside
the United Statesby the end of this year. The OvaPrime treatment is a potential new fertility treatment option for women who make too few or no eggs, which utilizes a woman’s own EggPC cells to increase her egg reserve for IVF.
Progressed OvaTureSM Treatment, a
Potential Hormone-Free Fertility Option, to Development
Demonstrated human preclinical proof-of-concept with the OvaTure treatment, showing for the first time that human EggPC cells can be matured into eggs outside of the body. In 2015,
OvaScienceplans to optimize the OvaTure process and define a development pathway. The OvaTure treatment is a potential next-generation IVF treatment that could help a woman produce healthy, young, fertilizable eggs without hormone injections.
Strengthened Financial Position
January 2015, the Company completed a public offering and received net proceeds of $124.1 million, which will primarily be used for the expanded international launch of the AUGMENT treatment, the planned international introduction of the OvaPrime treatment and the development of the OvaTure treatment.
Fourth Quarter and Full Year 2014 Financial Results
Net loss for the three months ended
December 31, 2014was $18.9 million, or ($0.79)per share, as compared to net loss of $11.0 million, or ($0.64)per share, for the three months ended December 31, 2013. This included non-cash stock-based compensation expense of $6.4 milliondue in large part to accounting of certain Founders’ stock. Net loss for the year ended December 31, 2014was $49.5 million, or ($2.19)per share, as compared to net loss of $29.0 million, or ($1.80)per share, for the year ended December 31, 2013. The year ended December 31, 2014included non-cash stock-based compensation expense of $12.4 million. The annual increase is primarily attributable to stock-based compensation, planned higher personnel costs, and costs associated with the launch of the AUGMENT treatment in select international regions. Launch costs include legal and consulting services and establishment of lab-based operations, which will also support introductions of future fertility treatments.
Research and development expense for the three months ended
December 31, 2014was $7.3 million, compared to $7.3 millionfor the same period in 2013. This included non-cash stock-based compensation expense of $3.8 million. Research and development expense for the year ended December 31, 2014was $21.8 million, compared to $15.8 millionfor the year ended December 31, 2013. The year ended December 31, 2014included non-cash stock-based compensation expense of $7.6 million. The annual increase is primarily attributable to increased stock-based compensation expense, due in large part to mark-to-market accounting of certain Founders’ stock, additional planned employee compensation, a license fee due as a result of our March 2014public offering. These were partially offset by 2013 technology access fees that did not recur in 2014.
Selling, general and administrative expense for the three months ended
December 31, 2014was $11.0 million, as compared to $3.7 millionfor the same period in 2013. This included non-cash stock-based compensation expense of $2.6 million. Selling, general and administrative expense for the year ended December 31, 2014was $26.1 million, as compared to $13.3 millionfor the year ended December 31, 2013. The year ended December 31, 2014included non-cash stock-based compensation expense of $4.8 million. The annual increase is primarily attributable to additional planned employee compensation, costs associated with the launch of the AUGMENT treatment in select international regions, professional fees including consulting and marketing, and stock-based compensation, due in large part to mark-to-market accounting for certain Founders’ stock.
2015 AUGMENT Revenue
This press release includes forward-looking statements about the Company’s plans for the AUGMENT treatment and its two fertility treatments in development, including statements relating to our plans to introduce the OvaPrime treatment in at least one international region by the end of 2015, our plans to expand the availability of the AUGMENT treatment, and our expectation that we will have 1,000 AUGMENT cycles in process by the end of 2015. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: the possibility that international IVF clinics that we work with may determine not to begin or continue providing the AUGMENT treatment for commercial or other reasons; our expectation that the AUGMENT treatment and OvaPrime treatment meet the requirements of a class of products exempt from premarket review and approval under applicable regulations in those countries where we have launched or plan to introduce the AUGMENT treatment and plan to introduce the OvaPrime treatment; the commercial ramp up of the AUGMENT treatment, which we expect will depend upon the successful transition of ACE clinics to commercial operations, the addition of new ACE clinics, and the results from ACE clinic experience as they become available; the science underlying our treatment and treatments in development (including the AUGMENT, OvaPrime and OvaTure treatments), which is unproven; our ability to obtain regulatory approval where necessary for our potential treatments; our ability to develop our potential treatments, including the OvaPrime and OvaTure treatments, on the timelines we expect, if at all; our ability to commercialize the AUGMENT treatment and our potential treatments, including the OvaPrime treatment, on the timelines we expect, if at all; as well as those risks more fully discussed in the “Risk Factors” section of our most recently filed Quarterly Report on Form 10-Q and/or Annual Report on Form 10-K. The forward-looking statements contained in this press release reflect our current views with respect to future events. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our view as of any date subsequent to the date hereof.
– Financial Tables to Follow –
|Condensed Consolidated Balance Sheets|
|As of December 31,|
|Cash and cash equivalents||$||6,414||$||18,078|
|Prepaid expenses and other current assets||1,647||650|
|Total current assets||61,878||45,077|
|Property and equipment, net||3,367||880|
|Investment in joint venture||-||1,500|
|Other long-term assets||130||-|
|Liabilities and stockholders’ equity|
|Total current liabilities||10,174||5,774|
|Other non-current liabilities||73||70|
|Total stockholders’ equity||55,325||41,701|
|Total liabilities and stockholders’ equity||$||65,572||$||47,545|
|Condensed Consolidated Statements of Operations|
|(In thousands, except per share data)|
Quarter Ended December 31,
|Year Ended December 31,|
Selling, general and
|Total operating expenses||18,289||11,013||
|Loss from operations||(18,289)||(11,013)||(47,933)||(29,134)|
Interest (expense) / income,
Other income / (expense),
Loss from equity method
Net loss per share—basic
Weighted average number