Flexion Therapeutics Announces Preliminary Third-Quarter 2020 ZILRETTA® Net Sales of Approximately $23.6 Million
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced
preliminary ZILRETTA (triamcinolone acetonide extended-release
injectable suspension) net sales of $23.6 million for the quarter
ended September 30, 2020.
“We are very pleased with our commercial performance in the
third quarter, which reflects strong quarter-over-quarter growth.
While it remains impossible to fully predict how COVID-19 might
impact our business over the coming months, it is highly
encouraging to see sales that are more in line with our
pre-pandemic expectations,” said Michael Clayman, M.D., President
and Chief Executive Officer of Flexion Therapeutics. “Each year,
healthcare providers administer approximately eight million
intra-articular injections to help patients manage osteoarthritis
knee pain. As clinicians gain more and more experience with
ZILRETTA, we firmly believe it will come to be recognized as a
best-in-class treatment option for those patients, and we will work
tirelessly to achieve its full potential.”
Commercial MetricsSince the
launch of ZILRETTA in November 2017 through September 30, 2020:
- 4,072 of 5,400
target accounts had purchased ZILRETTA, reflecting growth of 214
new purchasing accounts vs June 30, 2020 when 3,858 accounts
had purchased product.
- 77% of
purchasing accounts (3,153) placed at least one reorder up from
2,983 accounts that had reordered ZILRETTA as of June 30,
- 1,137 accounts
had made ZILRETTA purchases of more than 50 units; 1,143 accounts
had purchased 11 to 50 units; and 1,792 accounts had purchased
between 1 and 10 units.
- Accounts that
had purchased more than 50 ZILRETTA units accounted for 258,562 of
the total 295,641 ZILRETTA units purchased.
This financial information is preliminary and subject to
adjustment. Flexion expects to report its complete third-quarter
financial results in early November.
Conference CallFlexion’s management will host a
conference call today at 8:30 a.m. ET. A live webcast of the
conference call can be accessed through the “Investors” tab on the
Flexion Therapeutics website, and a replay will be available online
after the call. For those planning to ask a question, 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 #1222469. Please dial in at least 15 minutes in
advance to ensure a timely connection to the call.
Indication and Select Important Safety Information for
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.
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.
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
Adverse Reactions: The most commonly
reported adverse reactions (incidence ≥1%) in clinical studies
included sinusitis, cough, and contusions.
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.
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;
the long-term potential of ZILRETTA; expected increases in the rate
of individuals with OA of the knee; the potential for recognition
of ZILRETTA as a best-in-class treatment option; 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 June 30, 2020
filed with the SEC on August 5, 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.
Scott YoungVice President, Corporate Communications &
Investor RelationsT: firstname.lastname@example.org
Julie DownsAssociate Director, Corporate Communications &
Investor RelationsT: email@example.com
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