Financial Results
For the quarter ended June 30, 2018, Catalyst reported a GAAP net loss of $5,965,140, or $0.06 per basic and diluted share, compared to a GAAP net loss of $3,879,901, or $0.05 per basic and diluted share, for the same period in 2017. For the second quarter of 2018,Non-GAAP1 net loss was the same as GAAP net loss, as there were noNon-GAAP1 adjustments. In comparison,Non-GAAP1 net loss for the second quarter of 2017 was $4,090,232 or $0.05 per basic and diluted share, which excludesnon-cash gain of $210,331 attributable to the change in fair value of liability-classified warrants.
For the six months ended June 30, 2018, Catalyst reported a GAAP net loss of $11,665,032, or $0.11 per basic and diluted share, as compared to a GAAP net loss of $8,847,030, or $0.11 per basic and diluted share, for the same period in 2017. For the six months ended June 30, 2018,Non-GAAP1 net loss was the same as GAAP net loss, as there were noNon-GAAP1 adjustments. In comparison,Non-GAAP1net loss for the first six months of 2017 was $8,660,126, or $0.10 per basic and diluted share, which excludesnon-cash loss of $186,904 attributable to the change in fair value of liability-classified warrants.
Research and development expenses for the second quarter of 2018 were $3,704,824 compared to $2,451,751 in the second quarter of 2017. For the six months ended June 30, 2018, research and development expenses were $6,963,866 as compared to $5,265,680 in the same period in 2017. The increase in research and development expenses for the first six months of 2018 was primarily due to increases in consulting expenses as Catalyst prepared to submit its NDA for Firdapse during the first quarter of 2018, milestone expenses in connection with the acceptance of Catalyst’s NDA submission in May 2018, expenses from Catalyst’s medical affairs program, and compensation and related personnel costs, as Catalyst’s expands its headcount to support currently ongoing trials and programs. Catalyst expects that costs related to research and development activities will continue to be substantial throughout 2018 as it continues itson-going clinical studies and Expanded Access Program for Firdapse.
General and administrative expenses for the second quarter of 2018 totaled $2,631,031 as compared to $1,729,520 in the second quarter of 2017. For the six months ended June 30, 2018, general and administrative expenses were $5,305,429 as compared to $3,595,462 in the same period in 2017. The increase when compared to the same period in 2017 is primarily due to increases inpre-commercialization expenses, headcount and corporate expenses as Catalyst builds up its infrastructure and commercial programs in preparation for a potential launch of Firdapse in 2019. Catalyst expects general and administrative expenses, includingpre-commercialization expenses, to continue to increase in 2018 as Catalyst continues to expand its operations in preparation for a potential launch of Firdapse in 2019.
As a development-stage biopharmaceutical company, Catalyst had no revenues in either the second quarter of 2018 and 2017 or the first six months of 2018 and 2017.
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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