Flexion Therapeutics Reports Third-Quarter 2020 Financial Results and Recent Business Highlights
- Company reported ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) net sales of
$23 .7 million in third quarter 2020
“Throughout the third quarter, we saw strong execution across all areas of our business, and we were particularly pleased to achieve
Third-Quarter Results & Financial Highlights
The Company reported a net loss of
Cost of sales was
Research and development expenses were
Selling, general and administrative expenses were
Flexion expects full-year 2020 total operating expenses (including cost of sales, research and development, and selling, general and administrative) will be in the range of $172 million to $182 million.
Interest income was
As of
Recent News & Business Updates
- On
October 13, 2020 , Flexion pre-announced preliminary ZILRETTA net sales for the third quarter and provided updated Commercial metrics. - In
September 2020 , the first patient was treated in the mid-dose cohort of 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 and test three doses (low, mid and high dose) of FX201 in cohorts of five to eight patients. Following the completion of the first cohort in which five patients (Kellgren-Lawrence Grade 2 or 3) were treated with the low dose of FX201, safety data were collected and reviewed by an independent Drug Monitoring Committee (DMC). After evaluating the first cohort safety data, the DMC supported continuing the trial and initiating treatment in the next dosing cohort, which will include KL Grade 4 patients. The Company anticipates data from the study will be available in H2 2021. - Also in September, the Company announced the podium presentation of previously presented preclinical efficacy and pharmacokinetic data for FX301, its locally administered peripheral nerve block candidate for control of post-operative pain at the virtual ANESTHESIOLOGY 2020 meeting.
Indication and Select Important Safety Information for ZILRETTA
Indication: ZILRETTA is indicated as an intra-articular injection for the management of OA 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 (triamcinolone acetonide extended-release injectable suspension)
On
About FX201 (humantakinogene hadenovec)
FX201 is a novel, intra-articular gene therapy product candidate that utilizes a helper-dependent adenovirus [HDAd] vector based on human serotype 5 (Ad5) that is designed to transfer a gene to cells in the joint to produce an anti-inflammatory protein, interleukin-1 receptor antagonist (IL-1Ra), under the control of an inflammation-sensitive promoter. Inflammation is a known cause of pain, and chronic inflammation is thought to play a major role in the progression of OA. By persistently suppressing inflammation, Flexion believes FX201 holds the potential to provide long-term pain relief and functional improvement, and to modify the disease.
About FX301 (funapide formulated in a proprietary thermosensitive hydrogel)
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 and durable pain relief while preserving motor function and anticipates initiating clinical trials in 2021.
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 2017, approximately 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, approximately five million OA patients receive either a corticosteroid (immediate-release or extended-release) or hyaluronic acid intra-articular injection to manage their knee pain.
About
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 are forward looking statements, including, but not limited to, statements relating to the future of Flexion; expectations related to Flexion’s expenses for the year ended
CONDENSED CONSOLIDATED |
|||||||
STATEMENTS OF OPERATIONS | |||||||
(in thousands, except for per share information) | |||||||
Three Months Ended September 30, | |||||||
2020 | 2019 | ||||||
Revenue | $ | 23,664 | $ | 21,786 | |||
Operating expenses: | |||||||
Cost of sales | 5,130 | 2,872 | |||||
Research and development | 10,092 | 20,938 | |||||
Selling, general and administrative | 27,312 | 32,136 | |||||
Total operating expenses | 42,534 | 55,946 | |||||
Loss from operations | (18,870 | ) | (34,160 | ) | |||
Interest income (expense), net | (5,063 | ) | (3,931 | ) | |||
Other expense | (457 | ) | (141 | ) | |||
Loss from operations before income tax | (24,390 | ) | (38,232 | ) | |||
Income tax expense | 248 | - | |||||
Net loss | (24,638 | ) | (38,232 | ) | |||
Basic and diluted net loss per share | $ | (0.50 | ) | $ | (1.00 | ) | |
Basic and diluted weighted | |||||||
average number of common shares outstanding | 49,298 | 38,125 | |||||
CONDENSED CONSOLIDATED | |||||||
STATEMENTS OF OPERATIONS | |||||||
(in thousands, except for per share information) | |||||||
Nine Months Ended September 30, | |||||||
2020 | 2019 | ||||||
Revenue | $ | 59,242 | $ | 49,303 | |||
Operating expenses: | |||||||
Cost of sales | 12,887 | 6,032 | |||||
Research and development | 43,733 | 52,488 | |||||
Selling, general and administrative | 81,341 | 97,461 | |||||
Total operating expenses | 137,961 | 155,981 | |||||
Loss from operations | (78,719 | ) | (106,678 | ) | |||
Interest income (expense), net | (14,264 | ) | (9,974 | ) | |||
Other (expense) income | (581 | ) | 395 | ||||
Loss from operations before income tax | (93,564 | ) | (116,257 | ) | |||
Income tax expense | 495 | - | |||||
Net loss | (94,059 | ) | (116,257 | ) | |||
Basic and diluted net loss per share | $ | (2.16 | ) | $ | (3.06 | ) | |
Basic and diluted weighted | |||||||
average number of common shares outstanding | 43,563 | 38,043 | |||||
FLEXION THERAPEUTICS SELECTED BALANCE SHEET DATA | |||||||
(in thousands) |
|||||||
September 30, | |||||||
2020 | 2019 | ||||||
Cash and cash equivalents | $ | 128,637 | $ | 82,253 | |||
Marketable securities | 56,709 | 54,407 | |||||
Total current assets | 237,065 | 195,675 | |||||
Working capital | 186,187 | 159,456 | |||||
Total assets | 263,367 | 217,560 | |||||
Total notes payable | 60,694 | 40,176 | |||||
Total convertible notes | 160,360 | 153,413 | |||||
Total stockholders' deficit | (3,095 | ) | (20,108 | ) | |||
Contact:
Vice President,
T: 781-305-7194
syoung@flexiontherapeutics.com
Associate Director,
T: 781-305-7137
jdowns@flexiontherapeutics.com
Source: Flexion Therapeutics, Inc.