OvaScienceSM, (NASDAQ:OVAS), a global life sciences company focused on the discovery, development and commercialization of new fertility treatments, today reported first quarter 2014 financial results, and highlighted recent accomplishments. “We are on track with the international launch of our first fertility treatment, AUGMENT, in select IVF clinics this year,” said Michelle Dipp, M.D., Ph.D., Chief Executive Officer of OvaScience. “Training is underway, and we are confident that we can meet our goal to achieve at least 40 AUGMENT cycles and generate initial revenue by year end. We are also on schedule to launch our second fertility treatment, OvaPrime, in 2015. We expect to meet a critical milestone this year for OvaTure, which is to demonstrate human preclinical proof of concept for egg precursor cells in vitro. This quarter, OvaScience was issued three new patents covering our EggPC technology and potential applications, and raised an additional $55.2 million to support these and other near term milestones.” First Quarter and Recent Highlights
- Commenced Launch of AUGMENTSMInitiated the AUGMENT access program, targeting high-quality IVF clinics in four international regions, and expect to transition these clinics to commercial centers by year end. AUGMENT is the Company’s first fertility treatment and is designed to improve egg quality by adding energy from a woman’s egg precursor cells (EggPC) to her eggs during standard in vitro fertilization (IVF). Initial training is underway and manufacturing and operational efficiencies are being optimized for the first regions where AUGMENT will be available. These steps have laid a strong foundation for OvaScience to meet its goal of at least 40 AUGMENT cycles in 2014.
- Continued Commercial Preparations for OvaPrimeSM Launch in 2015Additional proof-of-concept studies are progressing for OvaPrime to support a planned international market introduction in 2015. OvaPrime is the Company’s fertility treatment that uses a woman’s EggPCs to boost her ovarian reserve.
- Advanced Preclinical Research for OvaTureSMPreclinical studies of OvaTure are ongoing and are designed to demonstrate human proof of concept for EggPCs in vitro, an important milestone anticipated in 2014. OvaTure is a potential next generation and hormone-free IVF treatment.
- Established Research Programs for OvaXonInitiated preclinical research for OvaXon, the Company’s joint venture with Intrexon Corporation. OvaXon is exploring potential applications of the combined EggPC technology and synthetic biology platforms for the prevention of genetic diseases and opportunities in animal breeding.
- Expanded Leadership, Board of Directors and AdvisorsThis quarter, OvaScience added David Stern, former head of the global fertility franchise at EMD Serono, to the management team as EVP of Global Commercial Operations. Mr. Stern’s strong relationships with fertility experts throughout the world have contributed to a targeted strategy for OvaScience’s international launches for AUGMENT and OvaPrime in 2014 and 2015, respectively. OvaScience also appointed Marc Kozin, former President North America, L.E.K. Consulting, to the Company’s Board of Directors and fertility pioneer Jamie Grifo, M.D., Ph.D., to its Advisory Board.
- Broadened Intellectual PropertyBuilding on its core Composition of Matter patent for EggPCs, OvaScience was issued three new patents during the first quarter of 2014, which cover its EggPC technology platform and related applications. These patents involve methods for isolating and manufacturing EggPCs, and methods patents related to AUGMENT which extend protection through at least 2032.
- Strengthened Financial PositionDuring the quarter, OvaScience raised $55.2 million in gross proceeds from the sale of 5.5 million shares of common stock in a public offering.In April, OvaScience announced that scientific Co-Founder, David Sinclair, Ph.D., was chosen by TIME as one of the 100 Most Influential People in The World. His research on aging and the key role of mitochondria (the energy source for all cells) contributed to the development of OvaScience’s foundational EggPC technology platform and related applications. The Company continues to work with Dr. Sinclair to study the impact of aging on egg quality and develop new treatments for female infertility.
- Net loss for the three months ended March 31, 2014 was $7.8 million, or ($0.41) per share, as compared to net loss of $5.2 million, or ($0.39) per share, for the three months ended March 31, 2013. The increase for the quarter was primarily attributable to $1.0 million in license fees, higher personnel costs, greater development expenses, and stock-based compensation expense.
- Research and development expense for the three months ended March 31, 2014 was $4.7 million, compared to $2.7 million for the same period in 2013. The increase for the quarter is primarily attributable to $1.0 million in license fees to Massachusetts General Hospital as a result of the public offering, a net increase in stock-based compensation expense, and planned personnel and development costs related to the advancement of AUGMENT, OvaPrime and OvaTure.
- General and administrative expense for the three months ended March 31, 2014 was $3.0 million, as compared to $2.5 million for the same period in 2013. The increase for the quarter is primarily due to higher personnel costs, including new employees hired to support the launch of AUGMENT, offset by a net decline in stock-based compensation expense.As of March 31, 2014, OvaScience had cash, cash equivalents and short-term investments of $89.5 million.
- Deutsche Bank 39th Annual Health Care Conference, May 7-8, 2014 in Boston, MA
- Jefferies Global Healthcare Conference, June 2-5, 2014 in New York, NY
- Annual Shareholder Meeting, June 13, 2014 in Boston, MA
- JMP Healthcare Conference, June 24-25, 2014 in New York, NY
- Janney Investor 1x1 Day, June 26, 2014 in Boston, MA
- European Society of Human Reproduction and Embryology, June 29-July 2, 2014 in Munich, Germany
|(A development stage company)|
|Condensed Consolidated Balance Sheets|
|As of March 31,||As of December 31,|
|Cash and cash equivalents||$||56,134||$||18,078|
|Prepaid expenses and other current assets||605||650|
|Total current assets||90,070||45,077|
|Property and equipment, net||1,202||880|
|Investment in joint venture||1,403||1,500|
|Liabilities and stockholders’ equity|
|Total current liabilities||6,287||5,774|
|Other non-current liabilities||74||70|
|Total stockholders’ equity||86,402||41,701|
|Total liabilities and stockholders’ equity||$||92,763||$||47,545|
|(A development stage company)|
|Condensed Consolidated Statements of Operations|
|(In thousands, except per share data)|
|Three Months Ended|
|Research and development||$||4,652||$||2,680|
|General and administrative||2,998||2,495|
|Total operating expenses||7,650||5,175|
|Loss from operations||(7,650)||(5,175)|
|Interest (expense) / income, net||(57)||18|
|Other income / (expense), net||(10)||-|
|Loss from equity method investment||(97)||-|
|Net loss applicable to common stockholders||$||(7,814)||$||(5,157)|
|Net loss per share applicable to common stockholders—basicand diluted||$ (0.41)||$ (0.39)|
|Weighted average number of common shares used in net loss pershare applicable to common stockholders—basic and diluted||19,214||13,345|