Selling, general and administrative expenses for the third quarter of 2019 totaled $8,067,792 as compared to $3,644,234 in the third quarter of 2018. For the nine months ended September 30, 2019, selling, general and administrative expenses were $25,471,974 as compared to $8,949,663 in the same period in 2018.The increase when compared to the same period in 2018 is primarily due to increased selling expenses, including costs of commercial system implementation, expansion of the Company’s sales force and supporting personnel, product launch expenses, market access and market research expenses, and professional fees associated with Catalyst’s lawsuit against the FDA. The Company expects selling, general and administrative expenses to increase in 2019 and into 2020, as the Company continues to build its infrastructure and commercial and patient programs in support of Firdapse sales activities and pursues its lawsuit against the FDA.
At September 30, 2019, Catalyst had cash and cash equivalents and investments of $81.6 million and no funded debt. Catalyst believes that its existing capital resources will be sufficient to support its planned operations for at least the next 12 months.
More detailed financial information and analysis may be found in the Company’s Quarterly Report on Form10-Q, which was filed with the Securities and Exchange Commission (SEC) on November 12, 2019.
Conference Call
Catalyst management will host an investment-community conference call and webcast at 8:30 a.m. ET, tomorrow, Wednesday, November 13, 2019 to discuss the financial results and provide a corporate update. Investors who wish to participate in the conference call may do so by dialing (877)407-8912 for domestic and Canadian callers or (201)689-8059 for international callers. Those interested in listening to the conference call live via the internet may do so by visiting the Investors page of the company’s website atwww.catalystpharma.com and clicking on the webcast link on the Investors home page. A webcast replay will be available on the Catalyst website for 30 days following the call by visiting the Investor page of the company’s website atwww.catalystpharma.com.
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), anti-MuSK antibody positive myasthenia gravis(MuSK-MG), congenital myasthenic syndromes (CMS), and spinal muscular atrophy (SMA) Type 3. Catalyst’s new drug application for Firdapse® (amifampridine) 10 mg tablets for the treatment of adults with LEMS was approved in November 2018 by the U.S. Food & Drug Administration (“FDA”), and Firdapse is now commercially available in the United States as a treatment for adults (age 17 and up) with LEMS.
Firdapse is being evaluated in clinical trials for the treatment ofMuSK-MG and SMA Type 3 and has received Orphan Drug Designation from the FDA for CMS and myasthenia gravis. Firdapse (amifampridine) 10 mg tablets is the first and only approved drug in Europe for the symptomatic treatment in adults with LEMS.
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst’s actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether the Company’s forecast for net revenue in full year 2019 and full year 2020 will prove correct, (ii) whether Catalyst can successfully increase sales of Firdapse through expansion of its sales personnel from current levels, (iii) whether, even if Catalyst achieves its forecasted net revenue targets, it will remain profitable, (iv) whether Catalyst will be able to compete successfully for adult LEMS patients againstoff-label use of Ruzurgi® (which is priced lower than
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