Lunes 20 de Agosto 2018

OvaScience Reports Third Quarter 2016 Financial Results

– Broadened Patient Access to AUGMENT with New Clinic Agreements in
Canada and Japan –

– Expanded AUGMENT Clinical Program with Institutional Review Board
(IRB) Approval for Company-Sponsored, Multi-Center Trial –

– Conference Call Today at 4:30 p.m. ET –

WALTHAM, Mass.–(BUSINESS WIRE)–OvaScienceSM (NASDAQ: OVAS), a global fertility company
focused on the discovery, development and commercialization of new
female infertility treatments, today reported its third quarter 2016
financial results and highlighted recent accomplishments.

“OvaScience is focused on laying the clinical and operational foundation
necessary to support the successful launch of AUGMENT in key
international regions,” said Harald Stock, Ph.D., President and Chief
Executive Officer of OvaScience. “To that end, we are working
expeditiously to further build clinical evidence supporting AUGMENT’s
use in a broader patient population, and to enter into additional
agreements in Canada and Japan. We also continue to progress our efforts
with OvaPrime and OvaTure, and look forward to providing updates on both
programs by year-end.”

Third Quarter and Recent Highlights

AUGMENTSM Treatment: The AUGMENT treatment
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
    OvaScience
    received 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. OvaScience expects 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 Controversies in 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.

    OvaScience continues to work
    with the IVI Group in 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. OvaScience
    remains 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 OvaScience entered 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, OvaScience expects the other clinics to become commercially
    active by the second quarter of 2017.

    OvaScience continues
    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 UAE continues to move forward and
    OvaScience intends 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, OvaScience together 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.

Corporate:

  • In September 2016, OvaScience announced the appointments of Christophe
    Couturier as Chief Financial Officer and Karen Long as Executive Vice
    President, Clinical and Regulatory Affairs and Quality Assurance, and
    the promotion of James Luterman to Executive Vice President, Research
    and Development.

Expected Milestones:

OvaScience remains on track to achieve the following milestones by
year-end:

  • Further expand patient access to AUGMENT in Canada and Japan, by
    partnering with additional clinics in those markets;
  • Begin enlisting sites for multi-center trial and progress IVI Group
    trial;
  • 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
    months ended September 30, 2016 was $532,000, compared to $120,000 for
    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,
    OvaScience recognized revenue related to 22 AUGMENT treatments for the
    full fiscal year.
  • Net loss for the quarter ended September 30, 2016 was $19.3 million,
    or ($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 million increase in
    employee compensation and related benefits driven by the hiring of
    additional research and development personnel, a $0.6 million increase
    in costs associated with certain ongoing research agreements, clinical
    studies, and other costs, partially offset by $0.5 million of
    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 million decrease in costs related to the establishment of certain
    legal entities as part of our international expansion during the third
    quarter of 2015, $0.8 million of 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 million increase 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 $126.7 million on
December 31, 2015. The increase reflects the net proceeds of $53.9
million received from the completion of OvaScience’s follow-on offering
in the second quarter of 2016.

Conference Call

OvaScience will host a conference call at 4:30 p.m. EDT today, Thursday,
November 3, 2016, to discuss these financial results and provide an
update on the Company. The conference call can be accessed by dialing
1-888-424-8151 (U.S.) or 1-847-585-4422 (International) five minutes
prior to the start of the call and providing the passcode 8448237.
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, November 3, 2016, through 11:59 p.m. EDT on Thursday, November
10, 2016, and may be accessed by visiting OvaScience’s website or by
dialing 1-888-843-7419 (U.S.) and 1-630-652-3042 (International). The
replay access code is 8448237.

About OvaScienceSM

OvaScience, Inc. (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 it believes 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 designed to
improve IVF success rates, is available in certain IVF clinics in select
international regions. 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. OvaScience treatments are not available in the U.S. For more
information, visit www.ovascience.com.

Forward-Looking Statements

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 Canada and Japan,
plans to develop further clinical evidence for AUGMENT (including
evidence in a broader population of patients), plans to begin enrolling
new patients in a new multicenter AUGMENT trial in the first quarter of
2017 and plans to read-out data on the trial by the end of 2017, plans
to broaden the use of AUGMENT, plans for a presentation on AUGMENT at
COGI in November 2017, plans to announce data from the IVI Group trial
in the second half of 2017, expected six to nine month on-board and
qualification time period between execution of commercial agreements
with clinics and when clinics begin offering the treatment commercially,
anticipated revenue by the second quarter of 2017 for certain clinics
that have signed commercial agreements, plans to provide an update on
the Company’s progress towards developing a U.S. market entry strategy
by year end, plans to provide an update by year-end on the future
clinical development path for OvaPrime based on an internal review of
preliminary data, and plans to provide an update on the path forward for
OvaTure 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 provide
or continue providing the AUGMENT treatment or OvaPrime treatment, or to
delay providing such treatments, or to limit the population of patients
receiving the treatment based on clinical efficacy, safety or
commercial, logistic, economic, available data, regulatory or other
reasons; the possibility that we may not succeed in signing new clinics
as expected, the possibility that it may take clinics longer than we
expect to generate revenue after execution of a commercial agreement,
challenges associated with enrolling and completing clinical trials, the
science underlying our treatments (including the AUGMENT, OvaPrime and
OvaTure treatments), which is unproven; our ability to obtain regulatory
approval or licenses where necessary for our treatments; our ability to
develop our treatments on the timelines we expect, if at all; our
ability to commercialize our treatments, 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 and Exhibit 99.3 to our current
report on Form 8-K filed with the Securities and Exchange Commission on
August 4, 2016. 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.

1 CDC
Assisted Reproductive Technology 2013 National Summary, page 5

 

OvaScience, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands, except share and per share data)

 
  As of September 30,   As of December 31,
2016 2015
Assets
Current assets:
Cash and cash equivalents $ 50,480 $ 43,224
Short-term investments 80,515 83,438
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  
Total assets $ 142,398   $ 138,613
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable $ 2,770 $ 3,352
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 liabilities 12,521 11,763
Total stockholders’ equity 129,877   126,850
Total liabilities and stockholders’ equity $ 142,398   $ 138,613
 
 

OvaScience, Inc.

Condensed Consolidated Statements of Operations and
Comprehensive Loss

(Unaudited)

(In thousands, except per share data)

 
  Three Months Ended
September 30,
  Nine Months Ended
September 30,
2016   2015 2016   2015
Revenues $ 197 $ 75 $ 532 $ 120
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 $ (19,291 ) $ (17,922 ) $ (59,617 ) $ (52,618 )
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
Net loss $ (19,291 ) $ (17,922 ) $ (59,617 ) $ (52,618 )
Other comprehensive loss:
Unrealized (losses) gains on available-for-sale securities   (31 )   22     148     (46 )
Comprehensive loss $ (19,322 ) $ (17,900 ) $ (59,469 ) $ (52,664 )
 

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Contacts

Media and Investor Contact:
OvaScience, Inc.
Jennifer
Viera, 617-420-8748
jviera@ovascience.com