Flexion Therapeutics, Inc. (Nasdaq:FLXN) today reported financial
results for the year-ended December 31, 2016 and provided an update
on the Company’s plans for a potential launch of Zilretta in Q4
2017. In February 2017, the Company announced that the U.S. Food
and Drug Administration (FDA) accepted its New Drug Application
(NDA) for Zilretta in osteoarthritis (OA) of the knee. Under the
Prescription Drug User Fee Act (PDUFA), the agency has established
a user fee goal date of October 6, 2017.
For 2016, the Company reported a net loss of $71.9 million as
compared to a net loss of $46.3 million for 2015. Research and
development expenses were $41.3 million and $32.7 million for the
years ended December 31, 2016 and 2015, respectively. The increase
in research and development expenses of $8.6 million in 2016, as
compared to 2015 was primarily a result of increased costs related
to the Company’s clinical development program for Zilretta and
expenses associated with the filing of an NDA for Zilretta in
December 2016. General and administrative expenses were $28.5
million and $13.4 million for the years ended December 31, 2016 and
2015, respectively. The increase in general and administrative
expenses of $15.1 million in 2016, as compared to 2015 was
primarily due to the development of corporate and commercial
infrastructure to support the potential launch of Zilretta.
As of December 31, 2016, the Company had $210.3 million in cash,
cash equivalents and marketable securities compared to $118.6
million as of December 31, 2015.
“The previous 12 months marked a period of remarkable progress
for Flexion Therapeutics,” said Michael Clayman, M.D., President
and Chief Executive Officer of Flexion. “We achieved many key
milestones, most notably, the successful filing of the NDA for
Zilretta. As a result, we have moved significantly closer to our
goal of commercializing medicines that can potentially have a
meaningful impact on patients, and we eagerly await the FDA’s
decision on Zilretta.”
Additional Corporate Highlights from 2016 and Recent
Months
- Presented Pivotal Phase 2b and Phase 3 trial result for
Zilretta at Osteoarthritis Research Society International (OARSI)
2016 World Congress
- Reported data from a 33 patient Phase 2 study which assessed
the effects of Zilretta on blood glucose levels in adults with OA
of the knee who also have Type 2 diabetes
- data showed that Zilretta was associated with a statistically
significant and clinically relevant reduction in the rise of blood
glucose compared to immediate-release triamcinolone acetonide (TA)
injection over 72 hours post dosing
- Conducted two highly successful public offerings raising
gross proceeds of approximately $147.9 million
- Initiated a clinical trial to investigate the safety of repeat
administration of Zilretta
- Announced key commercial leadership appointments of John Magee,
VP, Sales; Mark Fraga, VP, Marketing; and Dan Thornton, VP, Market
Access, in preparation for potential launch of Zilretta
- Appointed Scott Kelley, M.D., as VP, Medical Affairs
- Added Mark Stejbach, Senior Vice President and Chief Commercial
Officer at Alkermes plc, to the Board of Directors
Anticipated Events in 2017
- Potential approval of Zilretta NDA - PDUFA action date of
October 6, 2017
- Potential launch of Zilretta
- Complete enrollment of Zilretta repeat administration clinical
trial
- Ramp up of field sales force and other key positions, bringing
anticipated head count to ~250 by Q4
- Opening of Flexion’s Innovation Lab in Woburn, MA
Flexion also announced that Mr. Frederick Driscoll, Chief
Financial Officer, intends to retire effective March 31, 2017, due
to a personal family matter. To ensure a smooth transition, Mr.
Driscoll will continue with the Company in an advisory capacity
until his successor has been named.
Dr. Clayman added, “Working with Fred these past several years
has been one of the real highlights of my professional career. Fred
brought deep commitment, strategic insight and great goodwill to
the CFO position and has helped us build strong relationships with
investors and the banking community. His contributions to Flexion’s
success have been extraordinary. We wish him the very best in
retirement and are pleased that he will be available to consult
with us and assist in the identification of his successor.”
Conference CallFlexion’s management will host a
conference call today at 4:30 p.m. ET. The dial-in number for the
conference call is (855) 770-0022 for domestic participants and
(908) 982-4677 for international participants, with Conference ID #
77592180. A live webcast of the conference call can also be
accessed through the “Investors” tab on the Flexion Therapeutics
website. A webcast replay will be available online after the
call.
About Osteoarthritis of the Knee While OA is
being diagnosed at increasingly younger ages, prevalence rises
after age 45. In 2015, more than 14 million Americans were
diagnosed with OA of the knee. OA represents an enormous burden on
the U.S. healthcare system, affecting approximately 31 million
individuals and accounting for more than $185 billion in annual
expenditures. About 13 percent of women and 10 percent of men aged
60 years and older have symptomatic OA of the knee, with rates
likely to increase due to the aging of the population and the rate
of obesity or overweight individuals in the general population.
Each year, more than five million OA patients in the United
States receive either an immediate-release corticosteroid or
hyaluronic acid intra-articular injection for knee pain.
About Zilretta Zilretta is being investigated
as the first intra-articular, extended-release treatment for
patients with OA related knee pain. Zilretta employs proprietary
microsphere technology combining triamcinolone acetonide – a
commonly administered, short-acting corticosteroid – with a poly
lactic-co-glycolic acid (PLGA) matrix. To date, nearly 700 patients
have been treated with Zilretta in clinical trials.
About Flexion Therapeutics Flexion is a
specialty pharmaceutical company focused on the development and
commercialization of novel, local therapies for the treatment of
patients with musculoskeletal conditions, beginning with OA. The
company's lead product candidate, Zilretta, is being investigated
for its potential to provide improved analgesia for the millions of
U.S. patients who receive intra-articular injections for OA related
knee pain annually.
Forward-Looking StatementsStatements in this
press release regarding matters that are not historical facts,
including, but not limited to, statements relating to the future of
Flexion; our ongoing development of Zilretta and our other product
candidates; our interpretation of the data and results from our
Zilretta clinical trials, including our belief that we will not
need to conduct any additional clinical trials prior to submitting
an NDA, or receiving regulatory approval, for Zilretta; our plans
for, and the expected timing of, our Zilretta NDA submission with
the FDA; our plans to commercialize Zilretta and its market
potential; the potential benefits of the FDA’s Fast Track
designation for Zilretta, including the potential for an expedited
NDA review process; and the potential therapeutic and other
benefits of Zilretta and our other product candidates, are
forward-looking statements. These forward-looking statements are
based on management's expectations and assumptions as of the date
of this press release and are subject to numerous risks and
uncertainties, which could cause actual results to differ
materially from those expressed or implied by such statements.
These risks and uncertainties include, without limitation, risks
associated with the process of discovering, developing,
manufacturing and obtaining regulatory approval for drugs that are
safe and effective for use as human therapeutics; the fact that
results of past clinical trials may not be predictive of subsequent
trials; our reliance on third parties to manufacture and conduct
clinical trials of Zilretta and our other product candidates, which
could delay or limit their future development or regulatory
approval; our ability to meet anticipated clinical trial
commencement, enrollment and completion dates and regulatory filing
dates for Zilretta; the fact that we will require additional
capital, including prior to commercializing Zilretta or any of our
other product candidates, and may be unable to obtain such
additional capital in sufficient amounts or on terms acceptable to
us; the risk that we may not be able to maintain and enforce our
intellectual property, including intellectual property related to
Zilretta and our other product candidates; competition from
alternative therapies; regulatory developments and safety issues,
including difficulties or delays in obtaining regulatory approvals
to market Zilretta or our other product candidates; the risk that
the FDA and foreign regulatory authorities may not agree with our
interpretation of the data from our clinical trials of Zilretta and
may require us to conduct additional clinical trials prior to
filing applications for regulatory approval or granting regulatory
approval; Zilretta may not receive regulatory approval or be
successfully commercialized, including as a result of the FDA’s or
other regulatory authorities’ decisions regarding labeling and
other matters that could affect its availability or commercial
potential; risks related to key employees, markets, economic
conditions, health care reform, prices and reimbursement rates; and
other risks and uncertainties described in our filings with the
Securities and Exchange Commission (SEC), including under the
heading "Risk Factors" in our most recent Annual Report on Form
10-K and subsequent filings with the SEC. The forward-looking
statements in this press release speak only as of the date of this
press release, and we undertake no obligation to update or revise
any of the statements. We caution investors not to place
considerable reliance on the forward-looking statements contained
in this press release.
FLEXION THERAPEUTICS |
CONSOLIDATED STATEMENT OF
OPERATIONS |
(in thousands, except for per share
information) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
|
|
|
|
|
2016 |
|
|
2015 |
|
|
|
Revenue |
|
|
$ |
- |
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
Research and development |
|
|
|
41,314 |
|
|
32,691 |
|
|
|
General and administrative |
|
|
|
28,466 |
|
|
13,372 |
|
|
|
Total expenses |
|
|
|
69,780 |
|
|
46,063 |
|
|
|
Loss from
operations |
|
|
|
(69,780 |
) |
|
(46,063 |
) |
|
|
Interest
income (expense), net |
|
|
|
(226 |
) |
|
675 |
|
|
|
Other
income (expense) |
|
|
|
(1,887 |
) |
|
(927 |
) |
|
|
Loss from
operations before income tax |
|
|
|
(71,894 |
) |
|
(46,315 |
) |
|
|
Net
loss |
|
|
|
(71,894 |
) |
|
(46,315 |
) |
|
|
|
|
|
|
|
|
Basic and
diluted net loss per share |
|
|
$ |
(2.84 |
) |
$ |
(2.15 |
) |
|
|
Basic and
diluted weighted |
|
|
|
|
|
|
average
number of common shares outstanding |
|
|
|
25,296 |
|
|
21,497 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FLEXION THERAPEUTICS |
SELECTED BALANCE SHEET DATA |
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
December 31, |
|
|
|
|
|
|
2016 |
|
2015 |
|
|
|
|
|
|
|
Cash and cash
equivalents |
|
|
|
|
$ |
30,915 |
$ |
62,944 |
Marketable
securities |
|
|
|
|
|
179,413 |
|
55,660 |
Total current
assets |
|
|
|
|
|
209,394 |
|
112,103 |
Working capital |
|
|
|
|
|
191,853 |
|
104,044 |
Total assets |
|
|
|
|
|
226,262 |
|
127,139 |
Total notes
payable |
|
|
|
|
|
30,533 |
|
15,002 |
|
|
|
|
|
|
|
|
|
Total stockholders'
equity (deficit) |
|
|
|
|
|
187,032 |
|
103,986 |
|
|
|
|
|
|
|
|
|
Corporate Contacts:
Fred Driscoll
Chief Financial Officer
Flexion Therapeutics, Inc.
T: 781-305-7763
fdriscoll@flexiontherapeutics.com
Scott Young
Sr. Director, Corporate Communications & Investor Relations
Flexion Therapeutics, Inc.
T: 781-305-7194
syoung@flexiontherapeutics.com
Media Contact:
Danielle Lewis
Lazar Partners
T: 212-867-1768
flexionpr@lazarpartners.com
Investor Contact:
David Carey
Lazar Partners
T: 212-867-1768
dcarey@lazarpartners.com
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