For the quarter ended December 31, 2018, Catalyst reported a GAAP net loss of $14,499,609, or $0.14 per basic and diluted share, compared to a GAAP net loss of $5,387,698, or $0.06 per basic and diluted share, for the 2017 fiscal year. For the fourth quarter of 2018 and 2017,non-GAAP1 net loss was the same as GAAP net loss as there were nonon-GAAP1 adjustments.
Research and development expenses for the year ended December 31, 2018 were $19,919,204, compared to $11,375,237 for the 2017 fiscal year. For the fourth quarter of 2018, research and development expenses were $8,416,969, compared to $3,404,634 for the fourth quarter of 2017. The increase in research and development for 2018 when compared to 2017 is primarily due to increases in consulting expenses as Catalyst prepared to submit its NDA for Firdapse during the first quarter of 2018, milestone expenses relating to the acceptance and approval of Catalyst’s NDA submission, expenses from Catalyst’s medical affairs program, and compensation and related personnel costs as Catalyst expanded its headcount to support its currently ongoing trials and programs. Catalyst expects that costs related to research and development activities will continue to be substantial in 2019 as Catalyst works towards completing trials evaluating Firdapse for the treatment of CMS,MuSK-MG and SMA Type 3, continues its Expanded Access Program for Firdapse, and begins development of a sustained release formulation for Firdapse.
General and administrative expenses for the year ended December 31, 2018 totaled $15,875,961, compared to $7,304,399 in the 2017 fiscal year. For the fourth quarter of 2018, general and administrative expenses totaled $6,926,298, compared to $2,107,152 in the same period in 2017.Pre-commercialization costs of $6,897,483 and $809,584, respectively, were included in general and administrative expense in 2018 and 2017. The increase when compared to 2017 is primarily due to increases inpre-commercialization expenses, and headcount and corporate expenses as Catalyst built up its infrastructure and commercial programs in preparation for the launch of Firdapse in the first quarter 2019. Catalyst expects that going forward general and administrative expenses, excluding commercialization expenses, will be reported as selling expenses, and will continue to increase in 2019 as Catalyst continues to expand its operations to support the launch of Firdapse.
During the fourth quarter and year 2018, Catalyst had revenues of $500,000 from its collaboration with Endo for generic Sabril that began during December 2018. Catalyst had no revenues for the fourth quarter or year 2017.
At December 31, 2018, Catalyst had cash and investments of $58.5 million and no debt. Based on its current financial position and its forecasts of available cash, Catalyst believes that it has sufficient funds to support its operations for at least the next 12 months.
More detailed financial information and analysis can be found in Catalyst’s Annual Report on Form10-K for the fiscal year ended December 31, 2018, which was filed with the Securities and Exchange Commission earlier today.
| 1 | Statements made in this press release include anon-GAAP financial measure. Such information is provided as additional information and not as an alternative to Catalyst’s financial statements presented in accordance with U.S. generally accepted accounting principles (GAAP). Thisnon-GAAP financial measure is intended to enhance an overall understanding of Catalyst’s current financial performance. Catalyst believes that thenon-GAAP financial measure presented in this press release provides investors and prospective investors with an alternative method for assessing Catalyst’s operating results in a manner that Catalyst believes is focused on the performance of ongoing operations and provides a more consistent basis for comparison between periods. Thenon-GAAP financial measure in this press release excludes from the calculation of net loss the expense (or the income) associated with the change in fair value of the liability-classifiedwarrants. Non-GAAP net loss per share is calculated by dividingnon-GAAP net loss by the weighted average common shares outstanding. |
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