OvaScience Reports First Quarter 2014 Financial Results
-- Company Commenced International Launch of AUGMENTSM --
“We are on track with the international launch of our first fertility
treatment, AUGMENT, in select IVF clinics this year,” said
First Quarter and Recent Highlights
Commenced Launch of AUGMENTSM
Initiated 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
OvaScienceto meet its goal of at least 40 AUGMENT cycles in 2014.
Continued Commercial Preparations for OvaPrimeSM
Launch in 2015
Additional 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 Researchfor OvaTureSM
Preclinical 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 OvaXon
Initiated 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 Advisors
OvaScienceadded 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. OvaSciencealso 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 Property
Building on its core Composition of Matter patent for EggPCs,
OvaSciencewas 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 Position
During the quarter,
OvaScienceraised $55.2 millionin gross proceeds from the sale of 5.5 million shares of common stock in a public offering.
OvaScienceannounced 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.
First Quarter 2014 Financial Results
Net loss for the three months ended
March 31, 2014was $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 millionin license fees, higher personnel costs, greater development expenses, and stock-based compensation expense.
Research and development expense for the three months ended
March 31, 2014was $4.7 million, compared to $2.7 millionfor the same period in 2013. The increase for the quarter is primarily attributable to $1.0 millionin license fees to Massachusetts General Hospitalas 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, 2014was $3.0 million, as compared to $2.5 millionfor 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.
March 31, 2014, OvaSciencehad cash, cash equivalents and short-term investments of $89.5 million.
Upcoming Events and Presentations
Deutsche Bank39th Annual Health Care Conference, May 7-8, 2014 in Boston, MA
Jefferies Global Healthcare Conference, June 2-5, 2014in New York, NY
Annual Shareholder Meeting,
June 13, 2014in Boston, MA
JMP Healthcare Conference, June 24-25, 2014in New York, NY
Janney Investor 1x1 Day,
June 26, 2014in Boston, MA
European Society of Human Reproduction and Embryology, June 29-July 2, 2014in Munich, Germany
This press release includes forward-looking statements about the
prospects for the Company’s technology in addressing female infertility,
the Company’s strategy, future plans and prospects, and the development
and commercialization of the Company’s product candidates, including
statement relating to the Company’s planned international launch of
AUGMENT, the Company’s plans to generate initial AUGMENT revenue by the
end of 2014, the Company’s planned development and 2015 launch of
OvaPrime, the Company’s expectations of completing at least 40 cycles of
AUGMENT in 2014, the Company’s plan to demonstrate preclinical human
proof of concept for OvaTure in 2014, and the Company’s plans for its
joint venture with
– Financial Tables to Follow –
|(A development stage company)|
|Condensed Consolidated Balance Sheets|
|As of March 31,||As of December 31,|
|Cash and cash equivalents||$||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)||$||(5,157)|
Net loss per share applicable to common stockholders—basic
|$ (0.41)||$ (0.39)|
Weighted average number of common shares used in net loss per
Theresa McNeely, 617-299-7356
EVP, Strategic Corporate Communications