Flexion Therapeutics Announces Preliminary, Unaudited Fourth-Quarter and Full-Year 2019 Revenue and Initial Revenue Guidance...
January 09 2020 - 4:01PM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced
preliminary and unaudited revenue for the fourth-quarter and
full-year ended December 31, 2019 and provided initial revenue
guidance for 2020.
“We are very pleased with ZILRETTA’s performance
in the market, as our full-year 2019 sales of approximately $73
million represent strong year-over-year growth of more than 220%,”
said Michael Clayman, M.D., President and Chief Executive Officer.
“With our growing customer base and clinical utilization,
compelling patient feedback and a newly approved label, we are
increasingly excited about ZILRETTA’s potential to become the
leading intra-articular treatment for osteoarthritis knee pain.
This year marks another important step in that journey, and our
2020 revenue guidance reflects our expectation for continued
substantial ZILRETTA sales growth.”
Preliminary 2019 Results and Revenue
Guidance for 2020
- Unaudited revenue for the fourth quarter of 2019 is estimated
to be $23.7 million
- Total revenue for the full-year 2019 is estimated to be $73
million
- Flexion anticipates 2020 ZILRETTA® product revenue to be in the
range of $120 million to $135 million
This financial information is unaudited and
subject to adjustment. Flexion expects to report its complete 2019
financial results on its fourth-quarter and full-year earnings call
which will be held later in the first quarter of 2020.
Indication and Select Important Safety
Information for ZILRETTA (triamcinolone acetonide
extended-release injectable suspension)
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 ZILRETTA On 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 knee pain for 12 weeks, with some people experiencing pain
relief through Week 16.
About Osteoarthritis (OA) of the
Knee OA, also known as degenerative joint disease, affects
more than 30 million adults living in the U.S. 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, approximately five
million OA patients receive either an immediate-release
corticosteroid or hyaluronic acid intra-articular injection to
manage their knee pain.
About Flexion Therapeutics
Flexion Therapeutics (Nasdaq:FLXN) is a biopharmaceutical
company focused on the development and commercialization of novel,
local therapies for the treatment of patients with musculoskeletal
conditions, beginning with osteoarthritis, the most common form of
arthritis. The company's core values are focus, ingenuity,
tenacity, transparency and fun.
Visit flexiontherapeutics.com.
Forward-Looking Statements:
This 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; our expectations regarding revenues for the quarter and
full-year ended December 31, 2019 and the year ending December 31,
2020; expected sales growth of ZILRETTA; 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, risks that our actual
revenue for the fourth quarter and year ended December 31, 2019 may
differ materially from our estimated results for these periods as a
result of the completion of year-end closing procedures or the
audit of our financial statements; risk that we may not achieve
revenue expectations for 2020; 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,
including as a result of limitations in ZILRETTA's label and
package insert information; 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 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,
2019 filed with the SEC on November 7, 2019 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 RelationsFlexion Therapeutics, Inc.T:
781-305-7194syoung@flexiontherapeutics.com
Julie DownsSenior Manager, Corporate
Communications & Investor RelationsFlexion Therapeutics, Inc.T:
781-305-7137jdowns@flexiontherapeutics.com
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