Flexion Therapeutics Announces Preliminary Second-Quarter 2020 ZILRETTA® Net Sales
- Company reported ZILRETTA (triamcinolone acetonide extended-release injectable suspension) preliminary net sales of $15.4 million in the second quarter
- Demand for ZILRETTA from healthcare providers increased month-over-month throughout the second quarter with total demand in line with the first quarter
- Company plans to recommence ZILRETTA manufacturing in the fourth quarter following voluntary pause due to impacts from COVID-19
- Conference call scheduled for today at
8:30 a.m. ET
“Considering the unprecedented impacts of the COVID-19 pandemic, we are very pleased with our sales performance in the second quarter,” said
ZILRETTA Cumulative Commercial Metrics
Since the launch of ZILRETTA in
- 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.
Flexion’s management will host a conference call today at
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 Osteoarthritis (OA) of the Knee
OA, also known as degenerative joint disease, affects more than 30 million Americans and accounts for more than
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
Source: Flexion Therapeutics, Inc.