Flexion Therapeutics Reports First-Quarter 2019 Financial Results and Recent Business Highlights
- Company reported ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) net sales of $10.6 million in first quarter 2019
- Preliminary ZILRETTA net sales for
April 2019were approximately $5.1 million
- Flexion reaffirms full-year 2019 revenue guidance of
- Conference call scheduled for today at
4:30 p.m. ET
“Flexion delivered solid ZILRETTA sales performance in the first quarter of 2019,” said
First-Quarter Results & Financial Highlights
The Company reported a net loss of
Research and development expenses were
Selling, general and administrative expenses were
Interest income was
ZILRETTA Commercial Metrics
Since the launch of ZILRETTA in
- 2,247 of Flexion’s 4,100 target accounts had purchased ZILRETTA. This reflects growth of 22% over the period from launch through
December 31, 2018when 1,837 accounts had purchased product.
- 71% of purchasing accounts (1,601) had placed at least one reorder.
- More than 310 accounts had made ZILRETTA purchases of more than 50 units; approximately 700 accounts had purchased 11 to 50 units; and in excess of 1,200 accounts had purchased between 1 and 10 units.
- Accounts purchasing more than 50 ZILRETTA units have been responsible for more than 60% of total ZILRETTA purchases (approximately 38,000 units).
In addition, sampling of ZILRETTA equaled approximately 10% of the total ZILRETTA units purchased in the first quarter of 2019.
- Results from an “Awareness, Trial and Usage” (ATU) survey conducted in early
April 2019indicated 74% of the 120 orthopedic surgeons sampled had awareness of ZILRETTA and 32% had administered the product. By comparison, an ATU conducted in February 2018indicated that 42% of 118 orthopedic surgeons sampled were aware of ZILRETTA and only 9% had administered the product.
- At the 2019
Osteoarthritis Research Society International World Congress(OARSI) held in May, the Company presented positive results from the Phase 2 pharmacokinetic (PK) study evaluating ZILRETTA in patients with hip osteoarthritis (OA). The data show PK profiles consistent with previous studies in the knee. The Company also presented a poster on the previously published Phase 3b data indicating repeat administration of ZILRETTA resulted in substantial improvements in OA knee pain and had no deleterious impact on cartilage or joint structure. Additionally, the Company gave an encore poster presentation of data from an in vitro study, which suggests that triamcinolone acetonide can have dose-dependent chondroprotective effects on inflamed and injured cartilage.
April 2019, the Company announced that results from a post-hoc analysis of data from the pivotal Phase 3 trial of ZILRETTA were published in Advances in Therapy. The findings indicated that patients with unilateral OA knee pain experienced significant and durable pain relief with a single intra-articular injection of ZILRETTA compared to triamcinolone acetonide in crystalline suspension as measured by Average Daily Pain intensity scores. These results suggest that bilateral knee pain may have been a confounding factor in the pivotal trial, which assessed the impact of ZILRETTA treatment in only one knee.
- Also in April, an independent evaluation of clinical data for ZILRETTA conducted by Adis Drug Review, was published in the journal Drugs. Their assessment included data from six clinical trials conducted over the past seven years, which evaluated 1,347 patients, 613 of whom were treated with ZILRETTA. The evidence-based evaluation concluded that ZILRETTA provided effective pain relief, while being generally well-tolerated as demonstrated in clinical studies, and it expands the treatment options for OA knee pain.
- The Company has recently been made aware of a non-safety issue in the Phase 3 trial of ZILRETTA in hip OA pain, which resulted in the inability to deliver a full dose in a small number of trial participants. As a result, Flexion has temporarily paused enrollment and dosing as it works with investigators to identify and address the root cause of the issue.
- During the first quarter of 2019, the Company advanced Good Laboratory Practice toxicology studies for its preclinical gene therapy program, FX201, and pending successful results, anticipates filing an Investigational New Drug application and initiating first-in-human clinical trials in the second half of the year.
Flexion’s management will host a conference call today at
Indication and Select Important Safety Information for ZILRETTA® (triamcinolone acetonide extended-release injectable suspension)
Indication: ZILRETTA (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. It is not intended for repeat administration.
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 future financial and operating results; potential growth of ZILRETTA net sales; our estimates regarding revenues and net sales for
STATEMENTS OF OPERATIONS
|(in thousands, except for per share information)|
|Three Months Ended March 31,|
|Cost of sales||1,762||2,698|
|Research and development||15,424||11,551|
|Selling, general and administrative||32,222||26,899|
|Total operating expenses||49,408||41,148|
|Loss from operations||(38,844||)||(38,954||)|
|Interest income (expense), net||(2,925||)||(2,758||)|
|Other income (expense)||231||143|
|Loss from operations before income tax||(41,538||)||(41,569||)|
|Basic and diluted net loss per share||$||(1.09||)||$||(1.10||)|
|Basic and diluted weighted
average number of common shares outstanding
|FLEXION THERAPEUTICS SELECTED BALANCE SHEET DATA
|March 31,||December 31,|
|Cash and cash equivalents||$||87,935||$||87,299|
|Marketable securities (current and non-current)||129,913||171,555|
|Total current assets||247,958||285,042|
|Total notes payable||11,280||13,607|
|Total convertible notes||146,939||144,879|
|Total stockholders' equity||72,576||110,079|
Source: Flexion Therapeutics, Inc.