Catalyst Pharmaceuticals Announces First Quarter 2018 Financial Results and Provides Corporate Update
“We are pleased to continue to deliver on our key objectives for 2018, recently marked with the resubmission of our New Drug Application of Firdapse® for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS),” said
Q1-18 and Recent Highlights
- Resubmitted NDA for Firdapse for the treatment of LEMS
- Initiated sites and enrolled the first patient in the Phase 3 trial for MuSK-MG
- Continued progress with pre-commercialization activities for a potential launch of Firdapse
- Held positive Type C meeting with the
FDAto discuss Firdapse NDA submission for LEMS
- Ended March 31, 2018 with $77.9 million in cash and investments and no debt
- Expect the FDA’s decision regarding acceptance of the NDA for Firdapse in the second quarter of 2018
- Complete enrollment in the Phase 3 CMS (CMS-001) trial in second half of 2018
- Expect top-line results from Phase 3 CMS (CMS-001) trial in the first quarter of 2019
- Enroll first patient in SMA Type 3 proof of concept trial conducted in
For the quarter ended March 31, 2018, Catalyst reported a GAAP net loss of $5,699,892, or $0.06 per basic and diluted share, compared to a GAAP net loss of $4,967,129, or $0.06 per basic and diluted share, for the same period in 2017. For the first quarter of 2018, Non-GAAP1 net loss was the same as GAAP net loss as there were no Non-GAAP1 adjustments. Non-GAAP1 net loss for the first quarter of 2017 was $4,569,894, or $0.06 per basic and diluted share, which excludes non-cash loss of $397,235 attributable to the change in fair value of liability-classified warrants.
Research and development expenses for the first quarter of 2018 were $3,259,042 compared to $2,813,929 in the first quarter of 2017. The increase in research and development expenses for the first three months of 2018 was primarily due to consulting expenses as we prepared to submit our NDA for Firdapse for the treatment of LEMS during
General and administrative expenses for the first quarter of 2018 totaled $2,674,398 as compared to $1,865,942 in the first quarter of 2017. The increase when compared to the same period in 2017 is primarily due to increased pre-commercialization expenses. The Company expects general and administrative expenses, including pre-commercialization expenses, to increase in 2018 as we expand our operations and headcount to build up our infrastructure and commercial programs in preparation for a potential Firdapse launch in 2019.
As a development-stage biopharmaceutical company, Catalyst had no revenues in either the first quarter of 2018 and 2017.
At March 31, 2018, Catalyst had cash and cash equivalents and short-term investments of $77.9 million and no debt. Catalyst believes that its existing capital resources will be sufficient to support its planned operations through 2019 (without considering revenues and cash receipts that may be received in 2019 if Catalyst is successful in obtaining and approval of Firdapse and launching the product in 2019, of which there can be no assurance).
More detailed financial information and analysis may be found in the Company's Quarterly Report on Form 10-Q, which was filed with the Securities and Exchange Commission (
1 Statements made in this press release include a non-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). This non-GAAP financial measure is intended to enhance an overall understanding of Catalyst's current financial performance. Catalyst believes that the non-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. The non-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-classified warrants. Non-GAAP net loss per share is calculated by dividing non-GAAP net loss by the weighted average common shares outstanding.
Catalyst management will host an investment-community conference call and webcast at 8:30 a.m. ET, tomorrow,
Catalyst is also developing CPP-115 to treat refractory infantile spasms. CPP-115 has been granted U.S. Orphan Drug Designation for the treatment of infantile spasms by the
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 results of the LMS-003 trial, combined with the results of the Company's previous Phase 3 trial, will be acceptable to the
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
|For the Three Months Ended
|Operating costs and expenses:|
|Research and development||3,259,042||2,813,929|
|General and administrative||2,674,398||1,865,942|
|Total operating costs and expenses||5,933,440||4,679,871|
|Loss from operations||(5,933,440||)||(4,679,871||)|
|Other income, net||233,548||109,977|
|Change in fair value of warrants liability||--||(397,235||)|
|Loss before income taxes||(5,699,892||)||(4,967,129||)|
|Provision for income taxes||--||--|
|Net loss per share – basic and diluted||$||(0.06||)||$||(0.06||)|
|Weighted average shares outstanding – basic and diluted||102,557,350||82,972,316|
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||19,600,591||$||57,496,702|
|Prepaid expenses and other current assets||992,828||1,173,744|
|Total current assets||78,935,997||85,187,157|
|Property and equipment, net||183,370||191,385|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other liabilities||1,926,371||2,320,587|
|Total current liabilities||2,731,394||4,266,162|
|Accrued expenses and other liabilities, non-current||150,395||157,456|
|Total stockholders’ equity||76,246,466||80,963,812|
|Total liabilities and stockholders’ equity||$||79,128,255||$||85,387,430|
Brian KorbSolebury Trout (646) 378-2923 firstname.lastname@example.org Company Contact Patrick J. McEnany Catalyst PharmaceuticalsChief Executive Officer (305) 420-3200 email@example.com Media Contact David Schull Russo Partners(212) 845-4271 firstname.lastname@example.org
Source: Catalyst Pharmaceuticals, Inc.