Burlington, Massachusetts-based Flexion Therapeutics, Inc. reported that sales of its extended-release corticosteroid to treat OA knee pain jumped 82% to $28 million for the three months ended June 2021. In addition, in its report to shareholders, Flexion’s management noted that it is sitting on approximately $131.2 million total in cash, cash equivalent, and marketable securities as of June 30, 2021.
In short, strong sales and plenty of dry powder.
Net sales of the company’s flagship product ZILRETTA (triamcinolone acetonide extended-release injectable suspension) hit $28.2 million in the second quarter, up 82% from the prior year and 15% than the immediately preceding March quarter.
Flexion’s investment in marketing and R&D, which has been the basis for its growing market share and exceptional sales growth, was well managed in the quarter which, in turn, reduced net Q2 loss by $10.4 million (32%) compared to the same quarter in 2020, during the height of the COVID-19 impacted sales of ZILRETTA. Flexion also reiterated to its institutional investors and the Wall Street analyst cabal that full-year 2021 ZILRETTA net sales will probably come in somewhere between $120 million to $130 million.
FDA-approved in 2017, ZILRETTA is Flexion’s innovative intra-articular injection for osteoarthritis (OA) knee pain management. ZILRETTA is the first extended-release intra-articular treatment for OA knee pain. ZILRETTA total demand from healthcare providers in the second quarter grew by 7%.
OTW spoke with Flexion President and CEO Michael Clayman, M.D., about the company’s recent news. “We were pleased by ZILRETTA sales, $28 million (15% growth quarter over quarter) and we are confident enough to reiterate our guidance for the year of $120 to $130 million,” he said. Now used only in OA knee treatment, Flexion will additionally begin a ZILRETTA shoulder OA study before the end of the year, he added.
Also underway are clinical studies of product candidates FX201 and FX301. Flexion has stated that initial data from a FX201 single ascending dose/expansion knee OA study in approximately 70 patients, which is substantial for a gene therapy clinical trial, as well as full data for a FX301 bunionectomy study are expected by this year’s end. FX201 is an intra-articular gene therapy candidate for OA knee pain. FX301 is a 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. “The vision for FX301 is that it would provide greater duration of pain relief in addition to preservation of motor function in comparison to current peripheral nerve blockers,” Dr. Clayman said.
“At the end of the day, if you do drug development, what you are particularly thrilled about is defining things with clinical data and that’s what we’re doing in the coming months for two of our potentially transformative pipeline assets,” Dr. Clayman continued.
In July, Flexion entered into a second amendment to its Restated Credit and Security Agreement with Silicon Valley Bank, MidCap Financial Trust, Silicon Valley Bank, MidCap Funding XIII Trust, and other lenders. The company estimated that an amended credit facility will lead to roughly $59.0 million improvement to cash flow through 2023, in part due to payment of the outstanding 2019 loan balance and deferment of principal payments. “We’re also quite pleased to have financed our debt in a fashion that extends our estimated cash runway into 2023, which is important for us,” Dr. Clayman told OTW. “That refinancing…in essence saves us, in the near term, almost $60 million.”
Flexion has had much news to report in recent months, including the May announcement that Fred Driscoll would return to Flexion as Chief Financial Officer effective June 1, 2021, a June announcement of the appointment of William T. Andrews, M.D., as the new Chief Medical Officer, and the announcement of Utpal Koppikar’s appointment to its Board of Directors in July.
