Flexion Therapeutics Reports Fourth-Quarter and Full-Year 2019 Financial Results
- Company reported ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) net sales of $73.0 million for full-year 2019, representing more than 220% growth over 2018
- Analysis of Phase 3b trial investigating ZILRETTA in patients with knee OA and synovitis indicates treatment resulted in a significant reduction (>50%) in synovial tissue volume at Week 6 (primary endpoint) along with improvements in pain and function scores
- Conference call scheduled for today at
4:30 p.m. ET
“2019 marked an exciting period of growth for both Flexion and ZILRETTA,” said
2019 Financial Highlights
The Company reported a net loss of
Research and development expenses were
Selling, general and administrative expenses were
Interest expense was
ZILRETTA Commercial Metrics
Since the commercial launch of ZILRETTA in
- 3,488 of Flexion’s approximately 4,972 target accounts had purchased ZILRETTA. This compares to the 3,130 purchasing accounts over the period from launch through
September 30, 2019.
- 76% (2,642) of purchasing accounts had placed at least one reorder.
- 794 accounts had made ZILRETTA purchases of more than 50 units; 1,028 accounts had purchased 11 to 50 units; and 1,666 accounts had purchased between 1 and 10 units.
- Accounts purchasing more than 50 ZILRETTA units have been responsible for 81% of total ZILRETTA purchases (142,789 units).
March 2020, the Company announced the appointment of Melissa Laymanas Chief Commercial Officer. Ms. Laymanhas more than 25 years of commercial experience within the life science industry, most recently with Lantheus Medical Imagingwhere she served as Vice President for Global Sales and Marketing.
- Also in
March 2020, the first two patients were treated in a Phase 1 clinical trial evaluating the safety and tolerability of FX201 in patients with osteoarthritis (OA) of the knee. The open-label, dose-escalation study is expected to enroll 15 to 24 patients, 30-80 years of age, with symptomatic knee OA (Kellgren-Lawrence Grade 2 or 3). The Company anticipates data from the study will be available in 2021.
FX201 is a gene therapy product candidate designed to stimulate the production of an anti-inflammatory protein, interleukin-1 receptor antagonist (IL-1Ra), whenever inflammation is present within the joint. Based on preclinical data, the Company believes FX201 holds the potential to provide OA pain relief for a year or more and may slow disease progression.
- Flexion completed the primary endpoint analysis of its open-label, single-arm, Phase 3b trial assessing the effect of a single administration of ZILRETTA on synovitis in patients with knee OA. The data indicate that treatment with ZILRETTA resulted in a significant reduction (>50%) in synovial tissue volume at Week 6 compared to baseline (N=89 patients). These patients also reported improvements in pain and function scores over this time period. Patients continue to be followed in the trial to capture additional, longer-term exploratory measures as synovitis, or inflammation of the synovial membrane, is believed to play an important role in the progression of OA.
December 2019, Flexion announced that the FDA approved its supplemental New Drug Application (sNDA) for ZILRETTA. The revised product label removed language which previously stated that ZILRETTA was “not intended for repeat administration” and replaced it with new language stating that “the efficacy and safety of repeat administration of ZILRETTA have not been demonstrated.”
- Also in December, Flexion announced the enrollment of the first three patients in a clinical trial to evaluate the efficacy of ZILRETTA in patients with either shoulder OA or adhesive capsulitis (AC), also known as frozen shoulder. The Phase 2 double-blind, placebo-controlled, study is expected to enroll up to 250 patients – approximately 135 with shoulder OA and 115 with shoulder AC. The data are anticipated in 2021.
- In September, Flexion entered into a definitive agreement with Xenon Pharmaceuticals that provides the Company with the global rights to develop and commercialize XEN402, a NaV1.7 inhibitor, known as funapide, for control of post-operative pain. The new preclinical product candidate, known as FX301, consists of XEN402 formulated for extended release from a thermosensitive hydrogel for administration as a peripheral nerve block for control of post-operative pain. Flexion held a pre-IND meeting with FDA in January and remains on track to initiate FX301 clinical trials in 2021.
August 2019, the Company entered into an Amended and Restated Credit and Security Agreement with Silicon Valley Bank, MidCap Financial Trust, and Flexpoint MCLS Holdings, LLC, for a term loan of $40.0 millionand a revolving credit facility up to $20.0 million, both of which mature on January 1, 2024. The revolving credit facility is secured by a portion of the Company’s accounts receivable balance. The Company drew down the term loan of $40 millionin August and in February 2020drew down $20 millionfrom the revolving credit facility.
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 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.
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.
About Osteoarthritis (OA) of the Knee
OA, also known as degenerative joint disease, affects more than 30 million adults living in the
FX201 is a locally administered gene therapy product candidate which utilizes a helper-dependent adenovirus (HDAd) vector, designed to stimulate the production of an anti-inflammatory protein, interleukin-1 receptor antagonist (IL-1Ra), whenever inflammation is present within the joint. Inflammation is a known cause of pain, and chronic inflammation is thought to play a major role in the progression of osteoarthritis (OA). By persistently suppressing inflammation, Flexion believes FX201 holds the potential to both reduce OA pain and modify the disease.
FX301 is a locally administered NaV1.7 inhibitor product candidate, known as funapide formulated for extended release in a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. Flexion believes FX301 has the potential to provide effective pain relief while preserving motor function and anticipates initiating clinical trials in 2021.
About Flexion Therapeutics
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; our expectations regarding revenues for the year ended
STATEMENTS OF OPERATIONS
(in thousands, except for per share information)
|Cost of sales||9,960||7,336|
|Research and development||69,559||53,079|
|Selling, general and administrative||129,709||121,311|
|Total operating expenses||209,228||181,726|
|Loss from operations||(136,271)||(159,202)|
|Interest income (expense), net||(13,854)||(11,145)|
|Loss from operations before income tax||(149,773)||(169,659)|
|Basic and diluted net loss per share||$||(3.93)||$||(4.49)|
|Basic and diluted weighted|
|average number of common shares outstanding||38,086||37,751|
|FLEXION THERAPEUTICS SELECTED BALANCE SHEET DATA
|Cash and cash equivalents||$||82,253||$||87,299|
|Total current assets||195,675||285,042|
|Total notes payable||40,176||13,607|
|Total convertible notes||153,413||144,879|
|Total stockholders' (deficit) equity||(20,108)||110,079|
Source: Flexion Therapeutics, Inc.