OvaScience Reports Second Quarter 2016 Financial Results
— AUGMENT revenues increased 30% in 2Q16 compared to 1Q16 —
— Strong financial position enables execution of corporate strategy —
— Conference call today at
“Following our equity offering in June, which raised net proceeds of
Second Quarter and Recent Highlights
AUGMENT Treatment: The AUGMENTSM treatment is designed to improve egg health by using mitochondria from a woman’s own egg precursor (EggPCSM) cells during in vitro fertilization (IVF). Improved egg health is essential for fertilization and embryo development.
Progressed narrow and deep commercial efforts
OvaScienceentered into agreements with two new clinics in Canada. Both will join existing partners in offering the AUGMENT treatment commercially, following the completion of a preceptorship training program. With these additions, there are now six clinics offering AUGMENT in Canada, four of which signed on in the past six months.
During the second quarter, the Company continued to work closely with IVF Japan and
Yoshiharu Morimoto, M.D., Ph.D., to prepare for the anticipated commercialization of the AUGMENT treatment in Japan. In May 2016, OvaSciencesigned a letter of intent with IVF Japan. The Company is in the process of finalizing a commercial agreement with the clinic group.
As part of its geographic strategy,
OvaSciencediscontinued the availability of the AUGMENT treatment at partner clinics in Panamaand Turkey. OvaScienceis committed to minimizing the impact of this change to women and families in these regions.
Advanced ongoing egg allocation study
OvaSciencecontinues to work in tandem with the IVI Groupto progress its ongoing adaptive, controlled, double-blind, prospective and randomized egg allocation study. The study is designed to evaluate the safety and efficacy of AUGMENT in poor prognosis women, defined as those with at least one prior failed IVF cycle with embryo transfer and no pregnancy due to low embryo quality. OvaScienceexpects to announce data in the second half of 2017.
OvaPrimeSM Treatment: The OvaPrime treatment is a potential fertility treatment that could enable a woman who makes too few or no eggs to increase her egg reserve. Poor egg reserve affects approximately 25% of those seeking fertility treatment. The OvaPrime treatment is designed to transfer a woman’s EggPC cells to her own ovary, where they may mature into fertilizable eggs during a standard IVF process. In preclinical studies, OvaPrime was shown to result in a mature, fertilizable egg.
Expanded OvaPrime clinical program
OvaSciencebroadened its clinical program evaluating the OvaPrime treatment. OvaSciencerecently received approval from an Independent Review Board(IRB) to begin a study in Canadaled by Principal Investigator Robert Casper, M.D., FRCSC, Medical Director of TRIO Fertility based in Ontario. This study, like the one currently ongoing in the United Arab Emirates, will evaluate the safety of OvaPrime and changes in a patient’s hormone levels and follicular development as measured by ultrasound. OvaScienceintends to provide an update on the path forward with OvaPrime by year-end based on an internal review of preliminary data from these studies.
Presented preclinical data supporting the safety of the OvaPrime
European Society of Human Reproduction(ESHRE) Annual Meeting in July 2016, OvaSciencepresented preclinical data demonstrating the safety of EggPC cell repositioning in Cynomologus monkey ovaries using the OvaPrime method. In the six months post-treatment, no morbidity, mortality or treatment-related abnormalities were observed and no significant pre-to-post within-animal changes were found for body weight, hematology, serum chemistry or urinalysis parameters.
OvaTureSM Treatment: The OvaTure treatment is 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 outside the body. It may be an option for women with compromised eggs, who are unable to make eggs or may be unwilling or unable to undergo hormone hyperstimulation.
Continued to advance process for the OvaTure treatment
OvaScience continues to advance the OvaTure treatment and made progress in maturing and characterizing EggPC-derived eggs.
June 2016, OvaSciencesold 8,222,500 shares of its common stock at a price of $7.00per share. The Company received net proceeds from the offering of $53.9 million.
Further expand patient access to AUGMENT in clinics across
Work with IVF Japan to prepare for the commercialization of AUGMENT in
Progressenrollment in egg allocation study of AUGMENT;
- Provide an update on the path forward for OvaPrime; and
Provide an update on progress towards determining a
United Statesmarket entry strategy for AUGMENT.
Second Quarter Financial Results
Revenue for the quarter ended June 30, 2016 was $189,000, compared
to $30,000 for the same period in 2015. Revenue for the six months
June 30, 2016was $335,000, compared to $45,000for the same period in 2015. The Company recognized revenue related to 34 AUGMENT treatments in the second quarter of 2016, and related to 58 AUGMENT treatments in the first half of 2016, including treatments offered under various pricing programs. In 2015, OvaSciencerecognized revenue from 22 AUGMENT treatments for the full fiscal year.
Net loss for the quarter ended June 30, 2016 was $18.6 million,
$0.62) per share, compared to net loss of $17.5 million, or ( $0.64) per share, for the same period in 2015. Net loss for the quarter ended June 30, 2016included non-cash stock-based compensation expense of $2.2 million. 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 June 30,
2016 was $6.0 million, compared to $4.0 million for the same period in
2015. This increase was primarily driven by a $1.2 million increase in
employee compensation and related benefits driven by the hiring of
additional research and development personnel, a $0.5 million increase
in lab supplies and patient-related costs associated with our ongoing
clinical study being conducted by the
IVI Groupand a $0.3 million increase in facilities, consulting and other costs.
Selling, general and administrative expense for the quarter ended June
30, 2016, was $11.2 million, compared to $13.1 million for the same
period in 2015. This decrease was primarily a result of a
$2.4 milliondecrease in stock-based compensation expense, including $1.3 millionof pre-vest forfeitures as a result of the resignation of a senior executive in the current period and a decrease of $1.1 millionof stock-based compensation expense for senior executives that did not recur in 2016 as a result of executive leadership changes since the second quarter of 2015, which was partially offset by a $0.7 million increase in employee compensation and related benefits driven by the hiring of additional selling, general and administrative personnel.
As of June 30, 2016, OvaScience had cash, cash equivalents, and
short-term investments of $147.7 million, compared to
OvaScience will host a conference call at 4:30 p.m. EDT today, Thursday, August 4, 2016, to discuss these financial results and provide an update on the Company. The conference call can be accessed by dialing (888) 424-8151 (U.S.) or (847) 585-4422 (International) five minutes prior to the start of the call and providing the passcode 9515417. Additionally, the live, listen-only webcast of the conference call can be accessed by visiting the Investors section of the Company’s website at www.ovascience.com. A replay of the conference call will be available from 7:00 p.m. EDT on Thursday, August 4, 2016, through 11:59 p.m. EDT on Thursday, August 11, 2016, and may be accessed by visiting OvaScience’s website or by dialing (888) 843-7419 (U.S.) and (630) 652-3042 (International). The replay access code is 9515417.
This press release includes forward-looking statements about the
Company's plans for the AUGMENT treatment, OvaPrime treatment and
OvaTure treatment, including statements relating to the anticipated
commercialization of the AUGMENT treatment in
|Condensed Consolidated Balance Sheets|
|Cash and cash equivalents||$||95,894||$||43,224|
|Prepaid expenses and other current assets||2,458||3,199|
|Total current assets||150,111||129,861|
|Property and equipment, net||8,149||8,313|
|Other long-term assets||23||-|
|Liabilities and stockholders’ equity|
|Accrued expenses and other current liabilities||8,274||7,891|
|Total current liabilities||10,740||11,243|
|Deferred rent and other non-current liabilities||1,425||520|
|Total stockholders’ equity||146,557||126,850|
|Total liabilities and stockholders’ equity||$||158,722||$||138,613|
|Condensed Consolidated Statements of Operations|
|(In thousands, except per share data)|
Three Months Ended
Six Months Ended
|Costs and expenses:|
|Costs of revenues||1,233||116||2,409||151|
|Research and development||5,987||4,021||11,942||9,768|
|Selling, general and administrative||11,210||13,067||25,664||24,113|
|Total costs and expenses||18,430||17,204||40,015||34,032|
|Loss from operations||(18,241)||(17,174)||(39,680)||(33,987)|
|Interest income, net||161||101||335||145|
|Other (expense) income, net||(22)||(28)||(49)||6|
|Loss from equity method investment||(416)||(389)||(807)||(860)|
|Loss before income taxes||(18,518)||(17,490)||(40,201)||(34,696)|
|Income tax expense||50||-||125||-|
|Net loss per share—basic and diluted||$||(0.62)||$||(0.64)||$||(1.41)||$||(1.29)|
|Weighted average number of shares used in net loss per share—basic and diluted||30,036||27,198||28,668||26,894|
Media and Investor Contact:
Jennifer Viera, 617-420-8748