Catalyst Pharmaceuticals Announces Third Quarter 2018 Financial Results and Provides Corporate Update
Company to Host Quarterly Conference Call at
“We are extremely focused on executing on our launch-readiness plan as we prepare for the potential commercial launch of Firdapse® for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) early next year,” said
Q3-18 and Other Recent Highlights
- Continued progress with pre-commercialization activities for a potential launch of Firdapse in early 2019
- Appointed Dr.
Stanley Iyadurai as VP of Clinical Development - Recently added three additional medical science liaisons to our medical affairs team
- Number of current FTEs is 37 as compared to 18 at the beginning of this year
- FDA Acceptance of NDA and Priority Review Status for Firdapse for LEMS
- Ended the third quarter with
$66.7 million in cash and investments and no debt
Upcoming Milestones
- Prescription Drug User Fee Act (PDUFA) goal date of
November 28, 2018 for Firdapse for LEMS - Potential launch of Firdapse for LEMS in early 2019
- Enroll first patients in SMA Type 3 proof of concept study
- Complete enrollment in CMS Phase 3 trial
- Expect top-line results from Phase 3 CMS (CMS-001) trial in the second half of 2019
- Expect top-line results from Phase 3 trial for MuSK-MG in the second half of 2019
Financial Results
For the quarter ended
For the nine months ended
Research and development expenses for the third quarter of 2018 were
General and administrative expenses for the third quarter of 2018 totaled
As a development-stage biopharmaceutical company, Catalyst had no revenues in either the third quarter of 2018 and 2017 or the first nine months of 2018 and 2017.
At
More detailed financial information and analysis may be found in the Company's Quarterly Report on Form 10-Q, which was filed with the
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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.
Conference Call
Catalyst management will host an investment-community conference call and webcast at
About
Catalyst is also developing a generic version of Sabril® (vigabatrin).
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 Firdapse will ever be approved for commercialization, (ii) whether, even if Firdapse is approved for commercialization, Catalyst will be successful in commercializing Firdapse, (iii) whether Catalyst will be the first company to receive an approval for amifampridine (3,4-DAP), giving it 5-year marketing exclusivity for its product, and (iv) those other factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2017 and its other filings with the
CATALYST PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) |
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For the Three Months Ended September 30, |
For the Nine Months Ended September 30, |
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2018 | 2017 | 2018 | 2017 | ||||||||||||
Operating costs and expenses: | |||||||||||||||
Research and development | $ | 4,538,369 | $ | 2,704,923 | $ | 11,502,235 | $ | 7,970,603 | |||||||
General and administrative | 3,644,234 | 1,601,785 | 8,949,663 | 5,197,247 | |||||||||||
Total operating costs and expenses | 8,182,603 | 4,306,708 | 20,451,898 | 13,167,850 | |||||||||||
Loss from operations | (8,182,603 | ) | (4,306,708 | ) | (20,451,898 | ) | (13,167,850 | ) | |||||||
Other income, net | 343,730 | 129,059 | 947,993 | 330,075 | |||||||||||
Change in fair value of warrants liability | -- | -- | -- | (186,904 | ) | ||||||||||
Loss before income taxes | (7,838,873 | ) | (4,177,649 | ) | (19,503,905 | ) | (13,024,679 | ) | |||||||
Provision for income taxes | -- | -- | -- | -- | |||||||||||
Net loss | $ | (7,838,873 | ) | $ | (4,177,649 | ) | $ | (19,503,905 | ) | $ | (13,024,679 | ) | |||
Net loss per share – basic and diluted | $ | (0.08 | ) | $ | (0.05 | ) | $ | (0.19 | ) | $ | (0.16 | ) | |||
Weighted average shares outstanding – basic and diluted | 102,641,504 | 84,797,969 | 102,598,740 | 83,898,724 | |||||||||||
CATALYST PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS |
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September 30, | December 31, | ||||
2018 | 2017 | ||||
ASSETS | (unaudited) | ||||
Current Assets: | |||||
Cash and cash equivalents | $ | 10,616,313 | $ | 57,496,702 | |
Short-term investments | 51,047,842 | 26,516,711 | |||
Prepaid expenses and other current assets | 816,820 | 1,173,744 | |||
Total current assets | 62,480,975 | 85,187,157 | |||
Investments | 5,018,857 | -- | |||
Property and equipment, net | 201,093 | 191,385 | |||
Deposits | 8,888 | 8,888 | |||
Total assets | $ | 67,709,813 | $ | 85,387,430 | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
Current Liabilities: | |||||
Accounts payable | $ | 1,340,984 | $ | 1,945,575 | |
Accrued expenses and other liabilities | 2,127,450 | 2,320,587 | |||
Total current liabilities | 3,468,434 | 4,266,162 | |||
Accrued expenses and other liabilities, non-current | 164,781 | 157,456 | |||
Total liabilities | 3,633,215 | 4,423,618 | |||
Total stockholders’ equity | 64,076,598 | 80,963,812 | |||
Total liabilities and stockholders’ equity | $ | 67,709,813 | $ | 85,387,430 |
Investor ContactBrian Korb Solebury Trout (646) 378-2923 bkorb@troutgroup.com Company ContactPatrick J. McEnany Catalyst Pharmaceuticals Chief Executive Officer (305) 420-3200 pmcenany@catalystpharma.com Media ContactDavid Schull Russo Partners (212) 845-4271 david.schull@russopartnersllc.com
Source: Catalyst Pharmaceuticals, Inc.