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Exhibit 99.1

 

News Release

 

For Immediate Release

 

OvaScience Reports Third Quarter 2015 Financial Results

 

CAMBRIDGE, Mass., November 5, 2015 – OvaScienceSM (NASDAQ: OVAS), a global fertility company focused on the discovery, development and commercialization of new treatment options, today reported third quarter 2015 financial results and highlighted recent accomplishments.

 

“The recent publication of the AUGMENT patient experiences highlighted the clinical benefit of the treatment in patients with poor fertility prognoses,” said Michelle Dipp, M.D., Ph.D., Chief Executive Officer of OvaScience. “We continue to adapt our commercial operations to reflect rapid changes in the fertility market. Our high-quality, scalable manufacturing and technical operations give us confidence in our ability to expand into new territories, such as Europe and Japan, while building a strong foundation for introducing our other treatments. We remain on track to introduce our OvaPrime treatment this year through a preceptorship program in at least one international region to evaluate its potential in women with too few or no eggs. We also continue to expect to communicate by year end a development pathway for OvaTure, our next-generation, hormone-free approach to IVF.”

 

Third Quarter and Recent Highlights

 

·                  AUGMENTSM Treatment Peer-Reviewed Publication Showed Statistically Significant Improvements in Embryo Selection and Transfer Compared to Standard IVF

 

First published analysis comparing the AUGMENT treatment to standard IVF using an egg allocation method demonstrated statistically significant higher rates of embryo selection and transfer with the AUGMENT treatment based on standard embryo quality measures, including preimplantation genetic diagnosis/screening. Improved pregnancy rates with the AUGMENT treatment were also reported in the publication. These positive results were published in the Journal of Fertilization: In Vitro– IVF-Worldwide and presented at a recent scientific symposium. Additionally, physicians offering the AUGMENT treatment reported 22 babies born with the treatment to date. The AUGMENT treatment is not available in the United States.

 

·                  Hosted Scientific Symposium for Healthcare Providers on Advances in Egg Health

 

Participated in the American Society for Reproductive Medicine (ASRM) Annual Meeting and held a scientific symposium focused on educating clinicians on the importance of egg health and new advances in fertility. The event featured experts on the role of mitochondria for healthy embryogenesis and the potential of egg precursor (EggPCSM) cells for developing novel fertility treatments. In addition, a summary of the first published AUGMENT treatment patient experience was presented.

 



 

·                  On Track to Introduce the OvaPrimeSM Treatment Through Preceptorship Program

 

Company expects to meet goal of introducing the OvaPrime treatment to patients through a preceptorship program in at least one international region outside the United States by year end. This initial preceptorship program is a non-commercial training period in which physicians gain clinical experience using the OvaPrime treatment to replenish the ovarian reserve in women who make too few or no eggs. The Company expects physicians will share their initial patient experiences as clinically meaningful insights become available.

 

·                  Advanced Development Plans for the OvaTureSM Treatment

 

Finalizing plans for the further development of the OvaTure treatment, a next-generation fertility treatment designed to grow fresh, healthy eggs without the need for hormone injections. OvaScience still anticipates that by year end the Company will define its strategy for developing the OvaTure treatment outside the United States.

 

Third Quarter Financial Results

 

·                  Net loss for the three months ended September 30, 2015 was $17.9 million, or ($0.66) per share, as compared to net loss of $12.9 million, or ($0.54) per share, for the three months ended September 30, 2014. This included non-cash stock-based compensation expense of $3.7 million. The increase in net loss is primarily attributable to planned higher personnel costs, stock-based compensation, and costs associated with the launch of the AUGMENT treatment in certain international IVF clinics. Launch costs include legal and consulting services and establishment of lab-based operations, which will also support introductions of future fertility treatments.

 

·                  Research and development expense for the three months ended September 30, 2015 was $4.0 million, compared to $5.3 million for the same period in 2014. This decrease is primarily driven by a decrease of $0.8 million related to the stock-based compensation expense recorded in the prior year, including $1.1 million for Founders’ stock, which was fully expensed in the first quarter of 2015 and will not recur, and $0.4 million in certain collaboration agreements and research grants, which expired prior to the current period.

 

·                  Selling, general and administrative expense for the three months ended September 30, 2015 was $12.9 million, as compared to $7.1 million for the same period in 2014. This increase was primarily a result of $2.6 million for employee compensation and related benefits, including stock-based compensation expense driven by the hiring of additional personnel, $2.6 million of costs associated with the launch of the AUGMENT treatment and international growth, $0.4 million in facilities expenses, and $0.2 million in accounting, tax and other expenses.

 

At September 30, 2015, OvaScience had cash, cash equivalents and short-term investments of $141.7 million.

 

Upcoming Events and Presentations

 

·                  OvaScience Investor Day, December 17 in New York, NY

 



 

About OvaScience

 

OvaScience (NASDAQ: OVAS) is a global fertility company dedicated to improving treatment options for women around the world. OvaScience is discovering, developing and commercializing new fertility treatments because we believe women deserve more options. Each OvaScience treatment is based on the Company’s proprietary technology platform that leverages the breakthrough discovery of egg precursor (EggPCSM) cells – immature egg cells found inside the protective ovarian lining. The AUGMENTSM treatment, a fertility option specifically designed to improve egg health, is available in certain IVF clinics in select international regions outside of the United States. OvaScience is developing the OvaPrimeSM treatment, which could increase a woman’s egg reserve, and the OvaTureSM treatment, a potential next-generation IVF treatment that could help a woman produce healthy, young, fertilizable eggs without hormone injections. For more information, please visit www.ovascience.com and www.augmenttreatment.com and connect with us on Twitter and Facebook.

 

Forward-Looking Statements

 

This press release includes forward-looking statements about the Company’s plans for the AUGMENT treatment and two fertility treatments in development, including statements relating to our confidence in our ability to expand into new territories, including Europe and Japan, our plans to introduce the OvaPrime treatment this year through a preceptorship program, and our plans to communicate a development pathway for the OvaTure treatment by year end. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: the possibility that international IVF clinics that we work with may determine not to begin or continue providing the AUGMENT treatment for commercial or other reasons; our expectation that the AUGMENT treatment and OvaPrime treatment meet the requirements of a class of products exempt from premarket review and approval under applicable regulations in those countries where we have launched or plan to introduce the AUGMENT treatment and plan to introduce the OvaPrime treatment; the commercial ramp up of the AUGMENT treatment, which we expect will depend upon continued use of the AUGMENT treatment in our partner clinics in new and existing regions, significant uptake in the UAE as a result of the recent coverage, and other programs that include driving first-line use of the AUGMENT treatment, and further results from ACE clinic experience as they become available; the science underlying our treatment and treatments in development (including the AUGMENT, OvaPrime and OvaTure treatments), which is unproven; our ability to obtain regulatory approval where necessary for our potential treatments; our ability to develop our potential treatments, including the OvaPrime and OvaTure treatments, on the timelines we expect, if at all; our ability to commercialize the AUGMENT treatment and our potential treatments, including the OvaPrime treatment, on the timelines we expect, if at all; as well as those risks more fully discussed in the “Risk Factors” section of our most recently filed Quarterly Report on Form 10-Q and/or Annual Report on Form 10-K. The forward-looking statements contained in this press release reflect our current views with respect to future events. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our view as of any date subsequent to the date hereof.

 

- Financial Tables to Follow –

 



 

OvaScience, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands)

 

 

 

As of

 

 

 

September 30,
2015

 

December 31,
2014

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

50,842

 

$

6,414

 

Short-term investments

 

90,830

 

53,817

 

Prepaid expenses and other current assets

 

3,650

 

1,647

 

Total current assets

 

145,322

 

61,878

 

Property and equipment, net

 

6,717

 

3,367

 

Investment in joint venture

 

241

 

 

Restricted cash

 

527

 

197

 

Other long-term assets

 

 

130

 

Total assets

 

$

152,807

 

$

65,572

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

4,156

 

$

2,520

 

Accrued expenses and other current liabilities

 

5,707

 

7,654

 

Total current liabilities

 

9,863

 

10,174

 

Other non-current liabilities

 

358

 

73

 

Total liabilities

 

10,221

 

10,247

 

Total stockholders’ equity

 

142,586

 

55,325

 

Total liabilities and stockholders’ equity

 

$

152,807

 

$

65,572

 

 



 

OvaScience, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except per share data)

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2015

 

2014

 

2015

 

2014

 

Revenues

 

$

75

 

$

 

$

120

 

$

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Costs of revenues

 

940

 

 

1,091

 

 

Research and development

 

3,998

 

5,325

 

13,766

 

14,511

 

Selling, general and administrative

 

12,909

 

7,074

 

37,022

 

15,133

 

Total costs and expenses

 

17,847

 

12,399

 

51,879

 

29,644

 

Loss from operations

 

(17,772

)

(12,399

)

(51,759

)

(29,644

)

Interest income (expense), net

 

141

 

(25

)

286

 

(109

)

Other income, net

 

25

 

24

 

31

 

38

 

Loss from equity method investment

 

(316

)

(523

)

(1,176

)

(915

)

Net loss

 

$

(17,922

)

$

(12,923

)

$

(52,618

)

$

(30,630

)

Net loss per share—basic and diluted

 

$

(0.66

)

$

(0.54

)

$

(1.95

)

$

(1.38

)

Weighted average number of shares used in net loss per share—basic and diluted

 

27,267

 

23,766

 

27,020

 

22,192

 

 

Contacts:

 

Investors
Theresa McNeely

EVP, Chief Communications Officer

tmcneely@ovascience.com

617-299-7356

 

Media
Cara Mayfield

Director, Corporate Communications

cmayfield@ovascience.com

617-714-9638

 

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