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Catalyst Pharmaceuticals Announces Third Quarter 2014 Financial Results

Key Takeaway: Catalyst Pharmaceuticals Announces Third Quarter 2014 Financial Results CORAL GABLES, FL, November 14, 2014 Catalyst Pharmaceutical Partners, Inc. (Catalyst Pharmaceuticals) (Nasdaq: CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapi

Full Press Release Details

Catalyst Pharmaceuticals Announces Third Quarter 2014 Financial Results
CORAL GABLES, FL, November 14, 2014 Catalyst Pharmaceutical Partners, Inc. (Catalyst Pharmaceuticals) (Nasdaq: CPRX), a biopharmaceutical
company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today reported financial results for the third quarter and nine months ended September 30, 2014.
With the announcement of the positive results from our pivotal Phase 3 trial of Firdapse in LEMS, the third quarter was truly
transformative for Catalyst as it puts us on a pathway to initiate our NDA filing next year, said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst. We are committed to the LEMS patient community, currently suffering
with this debilitating disease, and will be launching our expanded access program shortly. With our recent Industry Forum at the AANEM conference, we ve seen enthusiastic support from the physician KOL s, as we continue to expand our
pre-commercial activities, raising awareness of LEMS and Firdapse .
For the quarter ended
September 30, 2014, Catalyst reported a GAAP net loss of $5,009,892, or $0.07 per basic and diluted share, compared to a GAAP net loss of $5,912,059, or $0.13 per basic and diluted share, for the same period in 2013. Excluding non-cash expense
of $906,787 attributable
to the change in fair value of liability-classified warrants, Non-GAAP1 net loss was $4,103,105 or $0.06 per share for the third quarter of
2014. In comparison, Non-GAAP1 net loss for the third quarter of 2013 was $3,235,458, or $0.07 per share, which excludes non-cash expense of $2,676,601 attributable to the change in fair value of
liability-classified warrants.
For the nine months ended September 30, 2014, Catalyst reported a GAAP net loss of $12,019,031, or $0.19 per basic
and diluted share, compared to a GAAP net loss of $10,799,938, or $0.25 per basic and diluted share, for the same period in 2013. Excluding non-cash expense of $1,465,892 attributable to the change in fair value of liability-classified warrants,
Non-GAAP1 net loss was $10,553,139 or $0.17 per share for the nine months ended September 30, 2014. In comparison, Non-GAAP1 net loss for
the nine months ended September 30, 2013 was $7,579,424, or $0.18 per share, which excludes non-cash expense of $3,220,514 attributable to the change in fair value of liability-classified warrants.
Research and development expenses for the third quarter of 2014 were $2,885,892, compared to $2,804,352 in the third quarter of 2013. For the nine months
ended September 30, 2014, research and development expenses were $7,733,533, compared to $6,028,691 in the comparable period of 2013. Research and development expenses for the nine months ended September 30, 2014 increased when compared to
the same period in 2013 as Catalyst continued its ongoing Phase 3 trial evaluating Firdapse for the treatment of LEMS and its other clinical trials and studies of Firdapse . Catalyst expects that research and development expenses will
continue to be substantial during 2014 as a result of ongoing development projects for both Firdapse and CPP-115.
General and administrative
expenses for the third quarter of 2014 totaled $1,223,137, compared to $441,424 in the third quarter of 2013. For the nine months ended September 30, 2014, general and administrative expenses totaled $2,874,034, compared to $1,576,044 in the
same period in 2013. The increase in general and administrative expenses is primarily due to an increase in non-cash stock based compensation due to timing of option awards, and consulting and marketing fees incurred in connection with the early
stages of pre-commercial activities for Firdapse .
As a development-stage biopharmaceutical company, Catalyst had no revenues in either the third
quarter of 2014 or the first nine months of 2014.
At September 30, 2014, Catalyst had cash and cash equivalents, certificates of deposit and
short-term investments of $41.4 million and no debt. Catalyst believes that its existing resources will be sufficient to support its currently anticipated operations through 2015.
Upcoming Investor Conferences
Catalyst s CEO, Patrick J. McEnany and COO/CSO, Dr. Steven Miller, will present at the following upcoming investor conferences:
Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people
with rare debilitating diseases, including Lambert-Eaton Myasthenic Syndrome (LEMS), infantile spasms, and Tourette Syndrome. Catalyst s lead candidate, Firdapse for the treatment of LEMS, is currently undergoing testing in a global,
multi-center, pivotal Phase 3 trial and has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). Firdapse is the first and only European approved drug for symptomatic treatment in adults with LEMS.
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 and Tourette Syndrome. CPP-115 has been granted U.S. orphan drug designation for the treatment of infantile spasms by the FDA and has been
granted E.U. orphan medicinal product designation for the treatment of West Syndrome by the European Commission.
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 whether the receipt of breakthrough therapy designation for Firdapse will expedite the development and review
of Firdapse by the FDA or the likelihood that the product will be found to be safe and effective, whether an NDA for Firdapse will ever be accepted for filing by the FDA, the timing of any such NDA filing or acceptance, whether Catalyst
will be the first company to receive approval for amifampridine (3,4-DAP), giving it 7-year marketing exclusivity for its product, whether any of Catalyst s product candidates will ever be approved for commercialization or successfully
commercialized, and those other factors described in Catalyst s Annual Report on Form 10-K for the fiscal year 2013 and its other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of
Catalyst s filings with the SEC are available from the SEC, may be found on Catalyst s 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.
Investor Contact Company Contact
Brian Korb Patrick J. McEnany
The Trout Group LLC Catalyst Pharmaceuticals
(646) 378-2923 Chief Executive Officer
bkorb@troutgroup.com (305) 529-2522
pmcenany@catalystpharma.com
Matt Middleman, M.D.
CATALYST PHARMACEUTICAL PARTNERS, INC.
CONDENSED STATEMENTS OF OPERATIONS (unaudited)
For the Three Months Ended September 30, For the Nine Months Ended September 30,
2014 2013 2014 2013
Operating costs and expenses:
Research and development $ 2,885,892 $ 2,804,352 $ 7,733,533 $ 6,028,691
General and administrative 1,223,137 441,424 2,874,034 1,576,044
Total operating costs and expenses 4,109,029 3,245,776 10,607,567 7,604,735
Loss from operations (4,109,029 ) (3,245,776 ) (10,607,567 ) (7,604,735 )
Interest income 5,924 10,318 54,428 25,311
Change in fair value of warrants liability (906,787 ) (2,676,601 ) (1,465,892 ) (3,220,514 )
Loss before income taxes (5,009,892 ) (5,912,059 ) (12,019,031 ) (10,799,938 )
Provision for income taxes
Net loss $ (5,009,892 ) $ (5,912,059 ) $ (12,019,031 ) $ (10,799,938 )
Net loss per share basic and diluted $ (0.07 ) $ (0.13 ) $ (0.19 ) $ (0.25 )
Weighted average shares outstanding basic and diluted 67,169,383 44,686,310 62,539,571 42,529,432
CATALYST PHARMACEUTICAL PARTNERS, INC.
CONDENSED BALANCE SHEETS
September 30, 2014 December 31, 2013
(unaudited)
ASSETS
Current Assets:
Cash and cash equivalents $ 11,263,677 $ 2,215,958
Certificates of deposit 3,714,634 4,011,576
Short-term investments 26,468,664 17,483,062
Prepaid expenses and other current assets 4,317,358 1,609,442
Total current assets 45,764,333 25,320,038
Property and equipment, net 71,280 40,628
Deposits 8,888 8,888
Total assets $ 45,844,501 $ 25,369,554
LIABILITIES AND STOCKHOLDERS EQUITY
Current Liabilities:
Accounts payable $ 524,795 $ 850,789
Accrued expenses and other liabilities 5,414,301 1,288,820
Total current liabilities 5,939,096 2,139,609
Accrued expenses and other liabilities, non-current 15,770 19,131
Warrants liability, at fair value 3,266,917 1,819,562
Total liabilities 9,221,783 3,978,302
Total stockholders equity 36,622,718 21,391,252
Total liabilities and stockholders equity $ 45,844,501 $ 25,369,554
Last updated: Nov 14, 2014