OvaScience Reports Third Quarter 2016 Financial Results
– Broadened Patient Access to AUGMENT with New Clinic Agreements in
– Expanded AUGMENT Clinical Program with
– Conference Call Today at
“OvaScience is focused on laying the clinical and operational foundation
necessary to support the successful launch of AUGMENT in key
international regions,” said
Third Quarter and Recent Highlights
AUGMENTSM Treatment: The AUGMENTtreatment is designed to improve egg health and with that, in vitro fertilization (IVF) success rates, by using mitochondria from a woman’s own egg precursor (EggPCSM) cells during IVF. Improved egg health is essential for fertilization and embryo development.
Continued developing robust clinical dataset for AUGMENT
OvaSciencereceived central Institutional Review Board(IRB) approval for a Company-sponsored, multi-center, controlled, double-blind, prospective, randomized, egg allocation trial to evaluate the efficacy of AUGMENT in a broad patient population. OvaScienceexpects to begin enrolling patients in the first quarter of 2017 and to announce initial data in the second half of 2017.
At the 24th
World Congress on Controversiesin Obstetrics, Gynecology & Infertility (COGI) in Amsterdam, Netherlands, taking place on November 10-13, 2016, a poster, “Live Birth Rates Following a Single Cycle of the AUGMENT Treatment,” will be presented. The poster includes a retrospective data analysis of live birth rates and safety profile following a single cycle of the AUGMENT treatment in women with one to five prior failed IVF cycles. OvaSciencecontinues to work with the IVI Groupin Valencia, Spain, to progress the ongoing, investigator-initiated, egg allocation trial of AUGMENT in poor prognosis women, defined by at least one prior failed IVF cycle with embryo transfer and no pregnancy due to low embryo quality. OvaScienceremains on track to announce data from this adaptive, controlled, double-blind, prospective and randomized trial in the second half of 2017.
Expanded commercial infrastructure to prepare for comprehensive
launches in key international regions
Supporting the Company’s deep and narrow regional expansion strategy, in the third quarter
OvaScienceentered into agreements with two new Canadian clinics, Victory and OriginElle, and finalized its agreement with the IVF Japan Group, a network that includes three clinics. New clinics will join existing clinics in offering the AUGMENT treatment following the completion of on-boarding and qualification activities, such as obtaining IRB or preceptorship approval and completing preceptorship training programs, which currently take approximately six to nine months. This quarter, four clinics offered the AUGMENT treatment on a commercial scale, two of which completed on-boarding and qualification activities in late September. Given the necessary required ramp-up time, OvaScienceexpects the other clinics to become commercially active by the second quarter of 2017. OvaSciencecontinues to work diligently to determine the necessary conditions that will enable the marketing of AUGMENT in the United States(U.S.), and has engaged with the U.S. Food and Drug Administration( FDA). The Company remains on track to provide an update on progress toward determining a U.S. market entry strategy by year-end.
OvaPrimeSM Treatment: Diminished ovarian reserve affects approximately 30% of those seeking fertility treatment.1 OvaPrime, a potential fertility treatment that could enable a woman who makes too few or no eggs to increase her egg reserve, is designed to transfer a woman’s EggPC cells to her own ovary, where they may mature into fertilizable eggs, as shown in preclinical studies.
Progressed OvaPrime clinical program
Patients are being enrolled in the second clinical trial of OvaPrime conducted at TRIO Fertility in
Ontario, Canada. The trial is designed to evaluate the safety of OvaPrime and changes in a patient’s hormone levels and follicular development as measured by ultrasound.
The OvaPrime clinical trial in the
UAEcontinues to move forward and OvaScienceintends to make a go/no-go decision on the future clinical development path for OvaPrime by year-end, based on an internal review of preliminary data.
OvaTureSM Treatment: The OvaTure treatment, a potential next-generation IVF treatment that could help a woman produce healthy, young, fertilizable eggs without hormone injections by maturing EggPC cells into eggs in-vitro, may be an option for women with compromised eggs, who are unable to make eggs or may be unwilling or unable to undergo hormone treatment.
Advanced preclinical development of OvaTure
In the third quarter,
OvaSciencetogether with its development partner Intrexon, identified a preferred media that supports early EggPC to oocyte maturation. The Company is now focused on furthering the culture process for late-stage oocyte maturation.
September 2016, OvaScienceannounced the appointments of Christophe Couturieras Chief Financial Officer and Karen Longas Executive Vice President, Clinical and Regulatory Affairs and Quality Assurance, and the promotion of James Lutermanto Executive Vice President, Research and Development.
Further expand patient access to AUGMENT in
Canadaand Japan, by partnering with additional clinics in those markets;
Begin enlisting sites for multi-center trial and progress
- Provide an update on path forward for OvaPrime and OvaTure; and
- Provide an update on progress toward determining a U.S. market entry strategy for AUGMENT.
Third Quarter Financial Results
Revenue for the quarter ended September 30, 2016 was $197,000,
compared to $75,000 for the same period in 2015. Revenue for the nine
September 30, 2016was $532,000, compared to $120,000for the same period in 2015. The Company recognized revenue related to 33 AUGMENT treatments in the third quarter of 2016, and related to 91 AUGMENT treatments in the first nine months of 2016. In 2015, OvaSciencerecognized revenue related to 22 AUGMENT treatments for the full fiscal year.
Net loss for the quarter ended September 30, 2016 was $19.3 million,
$0.54) per share, compared to net loss of $17.9 million or ($0.66) per share, for the same period in 2015. The increase in net loss was primarily attributable to planned higher personnel costs and costs associated with the commercial expansion of the AUGMENT treatment in certain international IVF clinics.
Research and development expense for the quarter ended September 30,
2016 was $5.0 million, compared to $4.0 million for the same period in
2015. This increase was primarily driven by a
$0.9 millionincrease in employee compensation and related benefits driven by the hiring of additional research and development personnel, a $0.6 millionincrease in costs associated with certain ongoing research agreements, clinical studies, and other costs, partially offset by $0.5 millionof stock-based compensation expense for certain senior executives that did not recur in 2016 as a results of executive leadership changes since the third quarter of 2015.
Selling, general and administrative expense for the quarter
ended September 30, 2016, was $12.6 million, compared to $12.9 million
for the same period in 2015. This decrease was mainly the result of a
$0.9 milliondecrease in costs related to the establishment of certain legal entities as part of our international expansion during the third quarter of 2015, $0.8 millionof stock-based compensation expense for certain senior executives that did not recur in 2016 as a result of executive leadership changes since the third quarter of 2015, partially offset by a $1.4 millionincrease in employee compensation and related benefits driven by the hiring of additional selling, general and administrative personnel.
As of September 30, 2016, OvaScience had cash, cash equivalents, and
short-term investments of $131.0 million, compared to
OvaScience will host a conference call at
This press release includes forward-looking statements about the
Company's plans for the AUGMENT treatment, OvaPrime treatment and
OvaTure treatment, including statements relating to the Company’s plans
to support a successful launch of AUGMENT in key regions, plans to enter
into additional commercial agreements for AUGMENT in
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
|As of September 30,||As of December 31,|
|Cash and cash equivalents||$||50,480||$||43,224|
|Prepaid expenses and other current assets||2,459||3,002|
|Short-term restricted cash||—||197|
|Total current assets||133,454||129,861|
|Property and equipment, net||8,047||8,313|
|Investment in joint venture||435||—|
|Long-term restricted cash||439||439|
|Other long-term assets||23||—|
|Liabilities and stockholders’ equity|
|Accrued expenses and other current liabilities||8,496||7,891|
|Total current liabilities||11,266||11,243|
|Deferred rent and other non-current liabilities||1,255||520|
|Total stockholders’ equity||129,877||126,850|
|Total liabilities and stockholders’ equity||$||142,398||$||138,613|
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share data)
Three Months Ended
Nine Months Ended
|Costs and expenses:|
|Costs of revenues||1,559||940||3,968||1,091|
|Research and development||4,990||3,998||16,932||13,766|
|Selling, general and administrative||12,612||12,909||38,276||37,022|
|Total costs and expenses||19,161||17,847||59,176||51,879|
|Loss from operations||(18,964||)||(17,772||)||(58,644||)||(51,759||)|
|Interest income, net||162||141||497||286|
|Other (expense) income, net||(33||)||25||(82||)||31|
|Loss from equity method investment||(364||)||(316||)||(1,171||)||(1,176||)|
|Loss before income taxes||(19,199||)||(17,922||)||(59,400||)||(52,618||)|
|Income tax expense||92||—||217||—|
|Net loss per share—basic and diluted||$||(0.54||)||$||(0.66||)||$||(1.92||)||$||(1.95||)|
|Weighted average number of shares used in net loss per share—basic and diluted||35,568||27,267||30,985||27,020|
|Other comprehensive loss:|
|Unrealized (losses) gains on available-for-sale securities||(31||)||22||148||(46||)|
Media and Investor Contact:
Jennifer Viera, 617-420-8748