Flexion Therapeutics Reports Second-Quarter 2021 Financial Results and Recent Business Highlights
- ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) net sales were
$28.2 million in Q2 2021, reflecting growth of 15% over the previous quarter
- Net loss in Q2 2021 decreased by
$10.4 million (32%), as compared to Q2 2020, during the height of the COVID-19 impact on ZILRETTA sales
- Company extends estimated cash runway into 2023 by refinancing term loan
- Flexion reiterates full-year 2021 ZILRETTA net sales guidance in the range of $120 million to $130 million
- Data for FX301 bunionectomy study and FX201 single ascending dose/expansion knee osteoarthritis (OA) study anticipated by year-end
- Conference call to be held today at
“We are encouraged by the growth of ZILRETTA sales in the second quarter of 2021, and today we are reiterating our full-year net sales guidance in the range of $120 million to $130 million,” said
Second-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
Net sales in the second quarter (
July 30, 2021, the Company entered into a second amendment to its Amended and Restated Credit and Security Agreement with Silicon Valley Bank, MidCap Financial Trust, MidCap Funding XIII Trust, and other lenders, providing for a term loan of up to $55.0 million available at closing and a revolving credit facility of up to $25.0 million. The Company concurrently borrowed the $55.0 million term loan and drew down $20.0 million from the revolver, bringing the total balance to $25.0 million, and used $48.1 million of the proceeds to repay the outstanding 2019 term loan and revolving loans under the existing credit agreement.
The applicable interest rate for the term loan under the amended credit facility is the greater of the prime rate plus 2.75% or 6.00%, and the interest rate for the revolving loan is the greater of the prime rate plus 1.75% or 5.00%. Under the credit facility, following an interest-only period ending on
August 1, 2023, principal is due in equal monthly installments through February 1, 2024, which may be extended to July 1, 2026, upon satisfaction of certain conditions. The Company estimates that the amended credit facility will result in an approximately $59.0 million improvement to cash flow through 2023, net of the term loan proceeds, payment of the outstanding 2019 term loan balance, and deferring principal payments.
July 2021, the Company fully enrolled the SAD portion of the Phase 1b proof-of-concept trial evaluating the safety and tolerability of FX301 administered as a single-dose, popliteal fossa block (a commonly used nerve block in foot and ankle-related surgeries) in patients undergoing bunionectomy. Based on the data, a decision will be made whether to expand a selected dose and volume cohort by another 36 patients. Results from this trial are expected by late 2021.
June 2021, the SAD part of the open-label, Phase 1 trial investigating FX201, an intra-articular gene therapy product candidate for OA knee pain, was fully enrolled. As of August 1, 40 patients had been treated across all cohorts, including the expansion groups of the low and mid doses. The most commonly observed treatment-related adverse events (AEs) in the trial have been pain, swelling, and effusion in the injected knee. In the second quarter, the Company made the strategic decision to investigate pretreatment with an intra-articular immediate release steroid prior to FX201 administration in up to 38 patients in expansion groups, as a means to mitigate potential AEs. Enrollment under the amended protocol has commenced, and additional data readouts are anticipated by the end of 2021.
July 12, 2021, Flexion announced the appointment of Utpal Koppikarto its Board of Directors.
June 9, 2021, the Company announced the appointment of William T. Andrews, M.D., as Chief Medical Officer.
May 12, 2021, Flexion announced that Fred Driscollwould rejoin the Company as Chief Financial Officer effective June 1, 2021.
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.
FX201 is an investigational gene therapy that utilizes a helper-dependent adenovirus (HDAd) vector devoid of all viral genes that carries a coding sequence for an anti-inflammatory protein called interleukin-1 receptor antagonist (IL-1Ra) under the control of an inflammation-responsive promoter. FX201 is injected directly into the joint space (also termed the intra-articular space) and is intended to deliver as-needed anti-inflammatory activity to joint tissues, with the goal of providing at least 6 to 12 months of meaningful pain relief and functional improvement following a single injection with the possibility of slowing disease progression.
FX301 is an investigational locally administered NaV1.7 inhibitor known as funapide, formulated for extended release in a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral analgesic nerve block for control of post-operative pain. Flexion believes FX301 has the potential to provide effective pain relief for at least three to five days while preserving motor function.
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; expectations regarding full-year 2021 net sales and operating expenses; projected cash runway and impacts from Flexion’s term loan refinancing; expected timing of clinical trials; expected increases in the rate of individuals with OA of the knee; and the potential therapeutic and other benefits of ZILRETTA and Flexion’s product candidates, 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, risk that Flexion may not achieve net sales and operating expense expectations for 2021; the potential future impacts of the COVID-19 pandemic and actions taken in response to the pandemic; the risk that we may not achieve anticipated growth or advancements in our development programs; the risk that we may not be able to successfully maintain an effective sales force to commercialize ZILRETTA; competition from alternative therapies; risks associated with clinical trials, including potential delays in enrollment or negative results; 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 key employees, markets, economic conditions, health care reform, prices, and reimbursement rates; and other risks and uncertainties described in our filings with the
STATEMENTS OF OPERATIONS
|(in thousands, except for per share information)|
|Three Months Ended
|Cost of sales||4,979||5,481|
|Research and development||12,669||12,507|
|Selling, general and administrative||27,409||24,730|
|Total operating expenses||45,057||42,718|
|Loss from operations||(16,882||)||(27,267||)|
|Interest expense, net||(5,003||)||(4,907||)|
|Loss from operations before income tax||(22,208||)||(32,371||)|
|Income tax expense||-||248|
|Basic and diluted net loss per share||$||(0.44||)||$||(0.76||)|
|Basic and diluted weighted average number of common shares outstanding||49,968||42,776|
STATEMENTS OF OPERATIONS
|(in thousands, except for per share information)|
|Six Months Ended
|Cost of sales||11,064||7,757|
|Research and development||26,716||33,641|
|Selling, general and administrative||55,007||54,029|
|Total operating expenses||92,787||95,427|
|Loss from operations||(40,023||)||(59,849||)|
|Interest expense, net||(9,892||)||(9,201||)|
|Loss from operations before income tax||(50,764||)||(69,173||)|
|Income tax expense||-||248|
|Basic and diluted net loss per share||$||(1.02||)||$||(1.71||)|
|Basic and diluted weighted average number of common shares outstanding||49,905||40,664|
|FLEXION THERAPEUTICS SELECTED BALANCE SHEET DATA
|Cash and cash equivalents||$||107,629||$||107,704|
|Total current assets||184,121||225,811|
|Total notes payable||53,735||60,920|
|Total convertible notes||167,814||162,786|
|Total stockholders' deficit||(56,171||)||(16,660||)|
Source: Flexion Therapeutics, Inc.