Flexion Therapeutics Announces Preliminary First-Quarter 2021 Revenue and Provides Financial Guidance for 2021
- First-quarter ZILRETTA® net sales estimated to be approximately
- 2021 full-year ZILRETTA net sales anticipated to be in the range of $120 million to $130 million and total operating expenses expected between $195 million to $205 million
- Company to hold conference call today at
4:30 p.m. ET
“Overall, we were pleased with our commercial performance in the first quarter. ZILRETTA net sales were broadly in line with our expectations, in spite of facing some unexpected delays in intra-articular procedures associated with the rollout of the COVID-19 vaccines and the extended power outages that affected
Preliminary Q1 2021 Results and Financial Guidance
- ZILRETTA net sales for the first quarter of 2021 are estimated to be approximately
- Flexion anticipates full-year 2021 ZILRETTA net sales to be in the range of $120 million to $130 million.
- Full-year 2021 total operating expenses, including cost of sales, research and development expenses, and selling, general and administrative expenses, are anticipated in the range of $195 million to $205 million.
- As of
March 31, 2021, the company had approximately $154 million in cash, cash equivalents, and marketable securities.
ZILRETTA Commercial Metrics
Since the launch of ZILRETTA in
- 4,417 accounts had purchased ZILRETTA, reflecting growth of 169 new purchasing accounts versus
December 31, 2020, when 4,248 accounts had purchased product.
- 79% of purchasing accounts (3,470) had placed at least one reorder, up from 3,321 accounts that had reordered ZILRETTA as of
December 31, 2021.
- 1,358 accounts had made ZILRETTA purchases of more than 50 units; 1,186 accounts had purchased 11 to 50 units; and 1,873 accounts had purchased between 1 and 10 units.
- Accounts that had purchased more than 50 ZILRETTA units accounted for 360,209 of the total 398,786 ZILRETTA units purchased.
This financial information is preliminary and subject to adjustment. Flexion expects to report its complete first-quarter financial results in early May.
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, is the most common form of arthritis affecting more than 32.5 million adults living in
This press 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; potential sales growth of ZILRETTA; estimates regarding net sales for the quarter ended
Source: Flexion Therapeutics, Inc.