Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced
preliminary ZILRETTA net sales of $15.4 million for the quarter
ended June 30, 2020. Demand for ZILRETTA increased month-over-month
throughout the second quarter with purchases by healthcare
providers reaching 4,863 units, 13,547 units and 18,287 units in
April, May and June, respectively. The total ZILRETTA purchases by
healthcare providers in the second quarter (approximately 36,700
units) was in line with the first quarter (36,540 units). In
addition, the Company also announced plans to recommence ZILRETTA
manufacturing in the fourth quarter to help ensure adequate and
uninterrupted supply to meet future demand.
“Considering the unprecedented impacts of the COVID-19 pandemic,
we are very pleased with our sales performance in the second
quarter,” said Michael Clayman, M.D., President and Chief Executive
Officer of Flexion Therapeutics. “While the future impacts of the
pandemic remain impossible to predict, our confidence in both the
near and long-term prospects for ZILRETTA remains
undiminished.”
Dr. Clayman added, “ZILRETTA is an important treatment option
for millions of people seeking durable pain relief from OA knee
pain, including those whose who have had knee replacement surgeries
deferred due to COVID-19. We believe this creates a new entry point
for prescribers to gain product experience in different patient
types and supports the broader incorporation of ZILRETTA into their
practices moving forward.”
ZILRETTA Cumulative Commercial Metrics Since
the launch of ZILRETTA in November 2017 through June 30, 2020:
- 3,858 of our approximately 5,000 target accounts had purchased
ZILRETTA. This reflects growth of 186 accounts since March 31,
2020 when 3,672 accounts had purchased product.
- 77% of purchasing accounts (2,983) placed at least one reorder
up from 2,832 accounts that had reordered ZILRETTA as of March 31,
2020.
- 1,023 accounts had made ZILRETTA purchases of more than 50
units; 1,102 accounts had purchased 11 to 50 units; and 1,733
accounts had purchased between 1 and 10 units.
- Accounts that had purchased more than 50 ZILRETTA units
accounted for 213,721 of the total 249,024 ZILRETTA units
purchased.
This financial information is preliminary and subject to
adjustment. Flexion expects to report its complete second-quarter
financial results in August.
Conference Call Flexion’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 #2618419. Please dial in at least 15 minutes in
advance to ensure a timely connection to the call.
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 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. Learn more at www.zilretta.com.
About Osteoarthritis (OA) of the Knee OA, 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 Therapeutics Flexion
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.
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;
expected impacts from COVID-19 and the timing and duration of such
impacts; expected timing of manufacturing activities and Flexion’s
ability to maintain commercial supply of ZILRETTA; the long-term
potential of ZILRETTA, including following the COVID-19 pandemic;
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 year ended March 31, 2020
filed with the SEC on May 7, 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
Flexion Therapeutics (NASDAQ:FLXN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Flexion Therapeutics (NASDAQ:FLXN)
Historical Stock Chart
From Sep 2023 to Sep 2024