OvaScienceSM, (NASDAQ: OVAS), a life sciences company focused on the discovery, development and commercialization of new treatments for infertility, today reported financial results for the quarter ended September 30, 2013, as well as recent highlights.
“We have continued to develop our EggPC SM technology platform and move forward with our planned international commercial activities for our first product candidate, AUGMENT SM,” said Michelle Dipp, M.D., Ph.D., Chief Executive Officer of OvaScience. “The team remains focused on a number of opportunities to make our products available to patients outside of the U.S., while research and development efforts are yielding enhancements to our EggPC processing capabilities and expanding our product pipeline. Additionally, we anticipate having further discussions with the FDA to determine next steps for AUGMENT in the U.S.”
Third Quarter and Recent Highlights
- Sponsored Continued Medical Education Program at the American Society of Reproductive Medicine/International Federation of Fertility Societies (ASRM/IFFS): Approximately 350 people attended the OvaScience sponsored symposium on “Strategies to Maximize Total Reproductive Potential: Emerging Concepts,” which featured presentations by leading reproductive endocrinologists, embryologists and fertility researchers.
- Appointed Hugh Taylor, M.D., world expert in endometriosis research at Yale School of Medicine, to Scientific Advisory Board. Also established a research agreement with Dr. Taylor to develop new treatments and diagnostic markers for endometriosis, a major cause of female infertility.
- Provided an update on AUGMENT: Chose to suspend enrollment in the AUGMENT Study in the U.S., pending further discussions with FDA. Plans for international commercial activities continue and the Company has expanded its manufacturing capabilities through a global supplier with expertise in cell therapy manufacturing.
- Participated in industry conferences and key advocacy events: CareFWD 2013 Healthcare Innovations Conference; Innovation Forum “Next 25 Years of Biotech” (Boston Chamber of Commerce), and the annual meetings of leading patient advocacy groups including the American Fertility Association (AFA), RESOLVE and RESOLVE New England.
Third Quarter 2013 Financial Results
- Net loss for the three months ended September 30, 2013 was $6.9 million, or ($0.40) per share, as compared to net loss of $3.1 million, or ($0.42) per share, for the three months ended September 30, 2012. The increase was primarily due to higher personnel costs including stock-based compensation expense due to significant organizational growth and AUGMENT development expenses.
- Research and development expense for the three months ended September 30, 2013 was $3.3 million, compared to $1.6 million for the same period in 2012. The increase was mostly due to higher personnel costs, including stock-based compensation expense, laboratory equipment impairment and greater AUGMENT contract research organization and consulting expenses.
- General and administrative expense for the three months ended September 30, 2013 was $3.7 million, as compared to $1.5 million for the same period in 2012. The increase was largely due to higher personnel costs, including stock-based compensation resulting from significant organizational growth, as well as additional consulting and commercial preparation expenses.
- As of September 30, 2013, OvaScience had cash, cash equivalents and investments of $49.6 million.
- Therapeutic Area Partnership Conference (Windover), November 18-20, Boston, MA
- Oppenheimer & Co. Healthcare Conference, December 10-11, 2013, New York, NY
|(A development stage company)|
|Condensed Consolidated Balance Sheets|
|September 30,||December 31,|
|Cash and cash equivalents||$||21,077||$||14,776|
|Prepaid expenses and other current assets||841||574|
|Total current assets||50,407||31,965|
|Property and equipment, net||730||756|
|Liabilities and stockholders’ equity|
|Total current liabilities||2,156||2,086|
|Other non-current liabilities||65||7|
|Total stockholders’ equity||49,004||30,721|
|Total liabilities and stockholders’ equity||$||51,225||$||32,814|
|(A development stage company)|
|Condensed Consolidated Statements of Operations|
|(In thousands, except per share data)|
|Three Months||Nine Months|
|September 30,||September 30,|
|Research and development||$||3,262||$||1,595||$||8,518||$||3,892|
|General and administrative||3,663||1,525||9,603||5,428|
|Total operating expenses||6,925||3,120||18,121||9,320|
|Loss from operations||(6,925)||(3,120)||(18,121)||(9,320)|
Net loss applicable to commonstockholders
Net loss per share applicable tocommon stockholders—basic anddiluted
|$ (0.40)||$ (0.42)||$ (1.14)||$ (2.69)|
Weighted average number of commonshares used in net loss per shareapplicable to common stockholders—basic and diluted