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Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced financial results for the year-ended December 31, 2014.
In February 2014, the successful completion of an initial public offering of Flexion common stock raised gross proceeds of approximately $75 million; and, in December 2014, a follow-on offering raised additional gross proceeds of approximately $98 million. At December 31, 2014, Flexion had cash, cash equivalents and marketable securities totaling $151.6 million compared to $16.4 million at December 31, 2013.
For 2014, the company reported a net loss of $27.3 million as compared to a net loss of $18.2 million for 2013. Research and development expenses were $17.9 million and $11.1 million for the years ended December 31, 2014 and 2013, respectively. The increase in research and development expenses of $6.8 million in 2014 as compared to 2013 was primarily a result of increased costs related to the company’s FX006 clinical development program and expenses associated with headcount additions throughout 2014. General and administrative expenses were $9.1 million and $6.7 million for the years ended December 31, 2014 and 2013, respectively. The increase in general and administrative expenses of $2.4 million in 2014 as compared to 2013 was primarily due to an increase in stock compensation expense, other employee-related costs due to increased headcount and expenses associated with being a publicly traded company.
Michael Clayman, M.D., President and Chief Executive Officer of Flexion, stated, “For Flexion Therapeutics, 2014 was a transformational year. We completed two public stock offerings that place the company in a strong position to execute on its business plan. To that end, the Flexion team has advanced FX006 into two pivotal clinical trials that we expect will form the basis for a regulatory submission for a product that has the potential to make a meaningful and durable difference for the many patients suffering from OA knee pain. In addition, we strengthened our board of directors and management team.”
Dr. Clayman continued, “We expect 2015 to be another important year for the company as the readout from our first pivotal trial will happen later this year along with completion of enrollment in our Phase 3 trial. With positive data from both trials we look forward to the prospect of filing a New Drug Application (NDA) thereafter.”
2014 and Recent Corporate Highlights
– In February 2014, completed a successful initial public offering of our common stock and raised gross proceeds of approximately $75 million; in December 2014, completed a follow-on financing, raising over $98 million. Total funds raised from both financings were more than $173 million
– Completed and reported positive data from the FX006 Phase 2a synovial fluid pharmacokinetic clinical trial
– Initiated and completed enrollment in a confirmatory, pivotal Phase 2b multi-center, randomized, double-blind, placebo-controlled study in 310 patients with OA of the knee. Results will address the safety, tolerability and efficacy of FX006
– Initiated a Phase 3 clinical trial of FX006 that will be the final step before submitting an NDA to the U.S. Food & Drug Administration
– Entered an exclusive worldwide licensing agreement with the SwRI® to use proprietary microsphere technology to produce Flexion’s sustained-release drug candidates, including FX006
– Received from the U.S. Patent and Trademark Office a composition of matter patent (No. 8828440), entitled “Corticosteroids for the Treatment of Joint Pain,” which provides coverage for FX006 into 2031
– Strengthened Flexion’s board of directors by adding Ann Merrifield, former President of Genzyme Biosurgery, Sandesh (Sandy) Mahatme, LLM, Senior Vice President, Chief Financial Officer at Sarepta Therapeutics, Inc. and Scott Canute, former President of Global Manufacturing and Corporate Operations at Genzyme Corporation
– Added several highly-skilled professionals with deep domain experience in Clinical Research, Regulatory Affairs, Quality Assurance, Commercial Operations and Legal Affairs
