Flexion Therapeutics Announces Preliminary, Unaudited Fourth-Quarter and Full-Year 2020 Results
January 13 2021 - 7:00AM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced
preliminary and unaudited net sales for the fourth quarter and full
year ended December 31, 2020.
“We are very pleased to report preliminary full-year 2020
ZILRETTA net sales of approximately $85.5 million,” said
Michael Clayman, M.D., President and Chief Executive Officer. “Our
strong sales reflect the expanding role ZILRETTA is taking in the
osteoarthritis knee pain treatment paradigm. We are encouraged by
our commercial performance despite the impacts of the pandemic, and
our confidence in ZILRETTA’s long-term prospects continues to
grow.”
Dr. Clayman added, “While ensuring the successful
commercialization of ZILRETTA is our highest priority, we remain
committed to building a pipeline of transformative medicines to
fuel our future growth, and we are pleased to announce that Adam
Muzikant, Ph.D. has been promoted to Chief Business Officer. Adam
was instrumental in the transactions that led to the FX201 and
FX301 programs and has been a driving force in the development of
our pipeline. His extensive experience and vision make him the
ideal person to assume this critical new role, and I look forward
to his continued contributions in the years ahead.”
Preliminary Unaudited 2020 Results
- Net sales for the fourth quarter of
2020 are estimated to be $26.3 million.
- Net sales for the full year 2020 are estimated to be
$85.5 million.
- As of December 31, 2020, the company had approximately
$175 million in cash, cash equivalents, and marketable
securities.
ZILRETTA Commercial Metrics
Since the launch of ZILRETTA in November 2017 through
December 31, 2020:
- 4,248 accounts had purchased ZILRETTA,
reflecting growth of 176 new purchasing accounts vs
September 30, 2020, when 4,072 accounts had purchased
product.
- 78% of purchasing accounts (3,321) placed at least one reorder,
up from 3,153 accounts that had reordered ZILRETTA as of
September 30, 2020.
- 1,242 accounts had made ZILRETTA purchases of more than 50
units; 1,170 accounts had purchased 11 to 50 units; and 1,836
accounts had purchased between 1 and 10 units.
- Accounts that had purchased more than 50 ZILRETTA units
accounted for 307,988 of the total 345,697 ZILRETTA units
purchased.
As a result of specialty distributor purchases in response to
growing customer demand and a modest distributor buy-in at a small
discount, the ZILRETTA inventory held by specialty distributors at
year-end was slightly above the 1 to 3 weeks the company
targets.
This financial information is preliminary and subject to
adjustment. Flexion expects to report its complete 2020 financial
results on its fourth-quarter and full-year earnings call, which
will be held later in the first quarter of 2021.
Indication and Select Important Safety Information for
ZILRETTA
Indication: ZILRETTA is indicated as an
intra-articular injection for the management of osteoarthritis pain
of the knee.
Limitation of Use: The efficacy and safety of repeat
administration of ZILRETTA have not been demonstrated.
Contraindication: ZILRETTA is
contraindicated in patients who are hypersensitive to triamcinolone
acetonide, corticosteroids or any components of the product.
Warnings and Precautions:
- Intra-articular Use
Only: ZILRETTA has not been evaluated and should not
be administered by epidural, intrathecal, intravenous, intraocular,
intramuscular, intradermal, or subcutaneous routes. ZILRETTA should
not be considered safe for epidural or intrathecal
administration.
- Serious Neurologic Adverse
Reactions with Epidural and Intrathecal
Administration: Serious neurologic events have been
reported following epidural or intrathecal corticosteroid
administration. Corticosteroids are not approved for this use.
- Hypersensitivity
reactions: Serious reactions have been reported with
triamcinolone acetonide injection. Institute appropriate care if an
anaphylactic reaction occurs.
- Joint infection and
damage: A marked increase in joint pain, joint
swelling, restricted motion, fever and malaise may suggest septic
arthritis. If this occurs, conduct appropriate evaluation and if
confirmed, institute appropriate antimicrobial treatment.
Adverse Reactions: The most commonly
reported adverse reactions (incidence ≥1%) in clinical studies
included sinusitis, cough, and contusions.
Please see ZilrettaLabel.com
for full Prescribing Information.
About ZILRETTAOn October 6, 2017, ZILRETTA was
approved by the U.S. FDA as the first and only extended-release
intra-articular therapy for patients confronting
osteoarthritis-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 provide extended pain
relief. The pivotal Phase 3 trial on which the approval of ZILRETTA
was based showed that ZILRETTA significantly reduced OA knee pain
for 12 weeks, with some people experiencing pain relief through
Week 16. Learn more at www.zilretta.com.
About Osteoarthritis (OA) of the KneeOA, also
known as degenerative joint disease, affects more than
30 million Americans and accounts for more than
$185 billion in annual expenditures. In 2016, more than
15 million Americans were diagnosed with OA of the knee, and
the average age of physician-diagnosed knee OA has fallen by 16
years, from 72 in the 1990s to 56 in the 2010s. The prevalence of
OA is expected to continue to increase as a result of aging,
obesity, and sports injuries. Each year, more than 15 million
Americans are treated for OA-related knee pain, and approximately
five million OA patients receive either an immediate-release
corticosteroid or hyaluronic acid intra-articular injection to
manage their knee pain.
About Flexion TherapeuticsFlexion Therapeutics
(Nasdaq:FLXN) is a biopharmaceutical company focused on the
development and commercialization of novel, local therapies for the
treatment of people with musculoskeletal conditions, beginning with
osteoarthritis, the most common form of arthritis. The Company's
core values are focus, ingenuity, tenacity, transparency, and fun.
Please visit www.flexiontherapeutics.com.
Forward-Looking StatementsThis release contains
forward-looking statements that are based on the current
expectations and beliefs of Flexion. Statements in this press
release regarding matters that are not historical facts, including,
but not limited to, statements relating to the future of Flexion;
the long-term potential of ZILRETTA; Flexion’s business strategy
and expectations with respect to its pipeline; estimated financial
and operating results; expected increases in the rate of
individuals with OA of the knee; and the potential therapeutic and
other benefits of ZILRETTA, 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, the fact that the impacts and expected duration of the
COVID-19 pandemic are uncertain and rapidly changing; the risk that
we may not be able to successfully maintain an effective sales
force to commercialize ZILRETTA; competition from alternative
therapies; the risk that we may not be able to maintain and enforce
our intellectual property, including intellectual property related
to ZILRETTA; the risk that ZILRETTA may not be successfully
commercialized or adopted; risks regarding our ability to obtain
adequate reimbursement from payers for ZILRETTA; risks related to
the manufacture and distribution of ZILRETTA, including our
reliance on sole sources of supply and distribution; risks related
to clinical trials, including potential delays, safety issues, or
negative results; 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 Quarterly Report on Form 10-Q
for the quarter ended September 30, 2020, filed with the SEC
on November 4, 2020, 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.
Contact:
Scott YoungVice President, Corporate Communications &
Investor RelationsT: 781-305-7194syoung@flexiontherapeutics.com
Julie DownsAssociate Director, Corporate Communications &
Investor RelationsT: 781-305-7137jdowns@flexiontherapeutics.com
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