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8-K - FORM 8-K - CATALYST PHARMACEUTICALS, INC. | d540103d8k.htm |
NEWS RELEASE | FOR IMMEDIATE RELEASE | |
For Further Information Contact: | ||
Patrick J. McEnany | Melody Carey | |
Catalyst Pharmaceutical Partners | Rx Communications Group | |
Chief Executive Officer | Co-President | |
(305) 529-2522 | (917) 322-2571 | |
pmcenany@catalystpharma.com | mcarey@rxir.com |
Catalyst Pharmaceutical Partners Reports First Quarter 2013 Financial Results
CORAL GABLES, FL, May 16, 2013 Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX), a specialty pharmaceutical company focused on the development and commercialization of novel prescription drugs targeting rare (orphan) neuromuscular and neurological diseases, today announced financial results for the three month period ended March 31, 2013.
Patrick J. McEnany, Catalysts Chief Executive Officer, Since the beginning of 2013, we have made solid progress towards completion of our 2013 corporate goals. We have completed the transfer of the Firdapse program from BioMarin and have started to add additional patients into the LMS-002 clinical trial for Firdapse to treat Lambert-Eaton Myasthenic Syndrome (LEMS). We have also made progress towards the opening of additional clinical trial sites in the U.S. and Europe. In that regard, we intend to regularly update the market regarding the status of our development efforts for Firdapse as these matters progress.
Financial Results
Catalyst reported a GAAP net loss of $1,744,289, or $0.04 per basic and diluted share, compared to a GAAP net loss of $1,089,186, or $0.04 per basic and diluted share, for the same period in 2012. Excluding non-cash expense of $45,326 attributable to the change in fair value of liability-classified warrants, Non-GAAP1 net loss was $1,698,963, or $0.04 per share for the first quarter of 2013. In
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 Catalysts financial statements presented in accordance with generally accepted accounting principles (GAAP). This non-GAAP financial measure is intended to enhance an overall understanding of Catalysts 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 Catalysts 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. |
comparison, Non-GAAP1 net loss for the first quarter of 2012 was $1,363,393, or $0.06 per share, which excludes non-cash income of $274,207 attributable to the change in fair value of liability-classified warrants.
Research and development expenses for the first quarter of 2013 were $1,092,301, compared to $727,327 in the first quarter of 2012. Research and development expenses increased when compared to the same period in 2012 as Catalyst expanded its activities associated with the currently ongoing phase III trial evaluating Firdapse for the treatment of LEMS. Catalyst expects that research and development expenses will increase during 2013 as a result of the ongoing development projects for Firdapse.
General and administrative expenses for the first quarter of 2013 totaled $613,129, compared to $637,383 in the first quarter of 2012.
As a development-stage specialty pharmaceutical company, Catalyst had no revenues in either the first quarter of 2013 or the first quarter of 2012.
At March 31, 2013, Catalyst had cash and cash equivalents, certificates of deposit and short-term investments of $13.2 million and no debt. Catalyst believes that its existing cash and investments will be sufficient to meet its projected operating requirements through the first quarter of 2014.
About Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners, Inc. is a specialty pharmaceutical company focused on the development and commercialization of novel prescription drugs targeting rare (orphan) neuromuscular and neurological diseases, including Lambert-Eaton Myasthenic Syndrome (LEMS), infantile spasms, and Tourette Syndrome. Catalysts lead candidate, Firdapse for the treatment of LEMS, is currently undergoing testing in a global, multi-center, pivotal phase III trial. Catalyst is also developing a potentially safer and more potent vigabatrin analog (designated CPP-115) to treat infantile spasms, and epilepsy, as well as other neurological conditions associated with reduced GABAergic signaling, like post-traumatic stress disorder, Tourette Syndrome, and movement disorders associated with the treatment of Parkinsons Disease.
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalysts actual results in future periods to differ materially from forecasted results. A number of factors, including whether the Phase III trial evaluating Firdapse for the treatment of LEMS will be successful, whether the Phase III trial will be completed on the expected timeline, whether Catalyst has sufficient resources to meet its projected operating requirements through the first quarter of 2014, as well as those factors described in Catalysts Annual Report on Form 10-K for the fiscal year 2012 and other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalysts filings with the SEC are available from the SEC, may be found on Catalysts website or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.
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CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
CONDENSED STATEMENTS OF OPERATIONS (unaudited)
For the Three Months
Ended March 31, |
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2013 | 2012 | |||||||
Revenues government grant |
$ | | $ | | ||||
Operating costs and expenses: |
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Research and development |
1,092,301 | 727,327 | ||||||
General and administrative |
613,129 | 637,383 | ||||||
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Total operating costs and expenses |
1,705,430 | 1,364,710 | ||||||
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Loss from operations |
(1,705,430 | ) | (1,364,710 | ) | ||||
Interest income |
6,467 | 1,317 | ||||||
Change in fair value of warrants liability |
(45,326 | ) | 274,207 | |||||
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Loss before income taxes |
(1,744,289 | ) | (1,089,186 | ) | ||||
Provision for income taxes |
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Net loss |
$ | (1,744,289 | ) | $ | (1,089,186 | ) | ||
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Net loss per share basic and diluted |
$ | (0.04 | ) | $ | (0.04 | ) | ||
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Weighted average shares outstanding basic and diluted |
41,420,687 | 24,710,362 | ||||||
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CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
CONDENSED BALANCE SHEETS
March 31, 2013 |
December 31, 2012 |
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(unaudited) | ||||||||
ASSETS |
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Current Assets: |
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Cash and cash equivalents |
$ | 646,045 | $ | 1,409,939 | ||||
Certificates of deposit |
5,005,380 | 6,502,825 | ||||||
Short-term investments |
7,507,146 | 7,504,444 | ||||||
Prepaid expenses |
1,242,785 | 1,309,470 | ||||||
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Total current assets |
14,401,356 | 16,726,678 | ||||||
Property and equipment, net |
57,747 | 53,679 | ||||||
Deposits |
8,888 | 8,888 | ||||||
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Total assets |
$ | 14,467,991 | $ | 16,789,245 | ||||
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current Liabilities: |
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Accounts payable |
$ | 567,185 | $ | 1,365,663 | ||||
Accrued expenses and other liabilities |
416,050 | 281,002 | ||||||
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Total current liabilities |
983,235 | 1,646,665 | ||||||
Accrued expenses and other liabilities, non-current |
21,265 | 21,878 | ||||||
Warrants liability, at fair value |
543,913 | 498,587 | ||||||
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Total liabilities |
1,548,413 | 2,167,130 | ||||||
Total stockholders equity |
12,919,578 | 14,622,115 | ||||||
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Total liabilities and stockholders equity |
$ | 14,467,991 | $ | 16,789,245 | ||||
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