OvaScienceSM, (NASDAQ: OVAS), a global life sciences company focused on the discovery, development and commercialization of new fertility treatments, today reported fourth quarter and year end 2013 financial results, and highlighted recent accomplishments.
“In 2013, we laid the foundation for the planned international launch of AUGMENT SM, advanced development of new fertility treatments and strengthened our management team,” said Michelle Dipp, M.D., Ph.D., Chief Executive Officer of OvaScience. “We are confident in our ability to deliver AUGMENT to patients in select international IVF clinics in 2014, and prepare for the launch of our newest potential fertility treatment, OvaPrime SM, in 2015. Research continues on OvaTure SM, a potential hormone-free approach to in vitro fertilization (IVF), and preclinical results which demonstrate that human egg precursor cells can be matured into fertilizable eggs are expected later this year.”
2013 and Recent Highlights
- Prepared for AUGMENT LaunchDeveloped AUGMENT Centers of Excellence (ACE) program to bring AUGMENT to patients in IVF clinics in at least four international regions in 2014. The Company expects to provide at least 40 to 60 AUGMENT cycles and to begin transitioning ACE clinics to commercial centers by year end.
- Broadened Spectrum of Potential Fertility TreatmentsAnnounced a new product, OvaPrime, which is being developed to boost a woman’s ovarian egg reserve. OvaPrime involves isolating a woman’s egg precursor cells (EggPC SM) and delivering them back into her ovaries prior to the standard IVF procedure. Additional development and product optimization are underway in anticipation of a commercial launch in 2015.
- Advanced OvaTure ResearchPartnered with Intrexon to accelerate preclinical development of OvaTure. By applying its industrialized high throughput screening, cell biology, cGMP and regulatory capabilities, Intrexon aims to deliver a preclinical data package to OvaScience within two years.
- Enhanced Leadership, Board of Directors and AdvisorsArthur Tzianabos, former head of research and early development at Shire, joined OvaScience as Chief Scientific Officer, while David Stern who was head of the global fertility franchise at EMD Serono, became Executive Vice President of Global Commercial Operations. New appointees to the OvaScience Board of Directors included Harald Stock, Ph.D., of the Getinge Group, Mary Fisher, President/CEO of Colorescience, and Marc Kozin, former President North America, L.E.K. Consulting. OvaScience also expanded its network of scientific and clinical advisors.
- Strengthened and Leveraged Intellectual PropertyBuilding on its core Composition of Matter patent for EggPCs, OvaScience was issued three new patents covering its technology platform and related products. On February 18, 2014, the Company was issued a U.S. patent covering methods for isolating EggPCs, and together with two other recently issued U.S. patents related to AUGMENT, patent protection is extended through at least 2032.Formed a Joint Venture with Intrexon, called OvaXon, to leverage intellectual property related to OvaScience’s EggPC technology platform. By applying Intrexon’s gene editing capabilities to EggPCs, OvaXon aims to prevent inherited diseases in humans and explore nearer term opportunities in animal health.
Fourth Quarter and Full Year 2013 Financial Results
- Net loss for the three months ended December 31, 2013 was $11.0 million, or ($0.64) per share, as compared to net loss of $4.2 million, or ($0.33) per share, for the three months ended December 31, 2012. Net loss for the year ended December 31, 2013 was $29.0 million, or ($1.80) per share, as compared to net loss of $13.5 million, or ($2.33) per share, for the year ended December 31, 2012. The increase for the quarter and the year was due to a one-time charge of $4.7 million for a technology access fee related to the Company’s collaboration with Intrexon, as well as higher personnel costs, including stock-based compensation. Under the collaboration agreement, the Company issued $2.5 million of common stock to Intrexon in December 2013, and will pay the remainder in cash in December 2014.
- Research and development expense for the three months ended December 31, 2013 was $7.3 million, compared to $2.4 million for the same period in 2012. Research and development expense for the year ended December 31, 2013 was $15.8 million, compared to $6.3 million for the same period in 2012. The increase for the quarter and the year was due to the $4.7 million technology access fee upon entering into a collaboration agreement with Intrexon, as well as higher personnel costs, including stock-based compensation expense.
- General and administrative expense for the three months ended December 31, 2013 was $3.7 million, as compared to $1.8 million for the same period in 2012. General and administrative expense for the year ended December 31, 2013 was $13.3 million, as compared to $7.2 million for the same period in 2012. The increase for the quarter and the year was primarily due to higher personnel costs, including stock-based compensation.