OvaScience Provides Update on Corporate Goal for AUGMENT Treatment
CAMBRIDGE, Mass.–(BUSINESS WIRE)–OvaScienceSM (NASDAQ: OVAS), a global fertility company
focused on the discovery, development and commercialization of new
treatment options, today announced that the Company does not expect to
meet the 2015 goal of 1,000 AUGMENTSM treatment cycles. The
AUGMENT treatment patient experience has been positive and OvaScience
has built strong technical operations, quality and manufacturing;
however, the Company is continuing to enhance its commercial operations
and infrastructure to optimize for commercial success. In addition,
evolving market dynamics in the fertility space, including recent merger
and acquisition activities at the key commercial IVF clinics where the
AUGMENT treatment is offered, have hindered the Company’s ability to
drive major volume that was anticipated in the fourth quarter.
Michelle Dipp, M.D., Ph.D., Chief Executive Officer of OvaScience,
stated, “We are adapting our regional commercial operations and
infrastructure as well as addressing an even more dynamic global IVF
landscape. In addition, we recently became aware of M&A activities in
our key clinics. We believe these factors will prevent us from achieving
our goal as we had anticipated the majority of AUGMENT treatment cycles
would initiate in the fourth quarter. While disappointing in the
short-term, the expanding clinic networks may enable more patients to
have access to the AUGMENT treatment. With the positive patient
experience to date, including multiple healthy births, we remain
confident in the commercial potential of the AUGMENT treatment and our
future fertility treatments.”
The Company established 2015 as a build year and made significant
advances in key areas:
-
Achieved quality and scalability of its global manufacturing and
technical operations; -
Published positive patient experiences, including the birth of ten
healthy babies, and will continue to demonstrate the clinical benefit
of the AUGMENT treatment by capturing additional data in its
international patient registry; -
Formed new clinic partnerships, including with the IVI Group, the
largest IVF clinic network in the world; and -
Advanced plans to introduce the AUGMENT treatment in Japan and the
United Kingdom.
Goals for the OvaPrimeSM and OvaTureSM treatments
remain on track for 2015, with plans to introduce the OvaPrime treatment
in patients outside of the United States and to communicate the
Company’s development strategy for the OvaTure treatment.
Conference Call and Webcast
OvaScience management will host a call on Tuesday, September 29, 2015 at
8:30 am ET. The call can be accessed by dialing (877) 930-8299 (U.S.) or
(253) 336-8765 (international) five minutes prior to the start of the
call and providing the passcode 50513264. A replay will be available
approximately two hours after completion of the call and can be accessed
by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and
providing the passcode 50513264. The replay will be available for two
weeks from the date of the call. 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 webcast will be archived on the Company’s website for
two weeks following the call.
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 its two fertility
treatments in development, including statements relating to (i) our
expectations with respect to our AUGMENT cycle goals, (ii) the potential
for expanding clinic networks to enable more patients to have access to
the AUGMENT treatment, (iii) plans to introduce the OvaPrime treatment
in patients outside of the United States and (iv) plans to communicate
the Company’s development strategy for the OvaTure treatment. 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; 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.
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Contacts
OvaScience
Theresa McNeely, 617-299-7356
EVP, Chief
Communications Officer
tmcneely@ovascience.com
or
Media:
Cara
Mayfield, 617-714-9638
Director, Corporate Communications
cmayfield@ovascience.com
