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. |
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Condensed Consolidated Balance Sheets |
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(Unaudited) |
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(In thousands, except share and per share data) |
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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. |
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Condensed Consolidated Statements of Operations and |
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(Unaudited) |
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(In thousands, except per share data) |
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Three Months Ended September 30, |
Nine Months Ended September 30, |
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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