Catalyst Pharmaceutical Partners, Inc. (NASDAQ:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today reported financial results for the fourth quarter and year-ended December 31, 2014.
“2014 was a year of great progress for Catalyst, clearly highlighted by the positive results from our pivotal Phase 3 Firdapse™ trial in LEMS,” saidPatrick J. McEnany, Chief Executive Officer of Catalyst. “As we look towards the NDA submission for Firdapse™ this year, we continue to build our commercial infrastructure, along with looking for Firdapse™ expansion opportunities to help patients beyond the LEMS indication. We continue to advance the development of our pipeline with results from the CPP-115 Phase 1 trial and the Tourette disorder open label study expected in the second quarter of 2015.”
2014 and Recent Highlights
- Positive top-line results from the pivotal Phase 3 clinical trial of Firdapse™ for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS).
- David D. Muth promoted to Chief Commercial Officer to develop and execute the Company’s strategic plan, including planning for the commercial launch of Firdapse™.
- Notice of Allowance of U.S. Patent Application for the Reduction or Elimination of Visual Field Defects by treating patients with CPP-115, covers CPP-115 for neurological and psychological uses until 2032.
- Raised $34.7 million, net of expenses, in a public offering of shares of common stock during February 2015, resulting in pro-forma cash and investments as of December 31, 2014 of approximately $74 million.
- Orphan drug designation granted for Firdapse™ by the FDA for treatment of patients with Congenital Myasthenic Syndromes (CMS).
- Encouraging Pre-NDA meeting with the FDA conducted.
- Launched our Firdapse™ Expanded Access Program. Catalyst is currently enrolling physicians treating LEMS and CMS patients in the expanded access program, which will provide Firdapse™ at no charge to their patients who meet the inclusion/exclusion requirements.
- The Company plans to complete a full NDA submission during the 3rd quarter of 2015.
- Exploration of additional indications for Firdapse™. Catalyst plans to continue to explore additional indications including Myasthenia Gravis caused by antibodies to muscle-specific tyrosine kinase (MuSK MG).
- The Company is continuing to focus on pre-commercial activities as we plan for an estimated approval / launch of Firdapse™ in 1H 2016.
- CPP-109: Top-line results from Tourette disorder. An academic investigator sponsored study evaluating CPP-109 for the treatment of Tourette disorder is ongoing at Mt. Sinai and the Company expects to announce topline results in the second quarter of 2015.
- CPP-115: Catalyst expects to announce topline results from a Phase 1 multiple dose safety and tolerance study in the second quarter of 2015.
Fourth Quarter and Full-Year 2014 Financial Results
For the year ended December 31, 2014, Catalyst reported a GAAP net loss of $15,509,061, or $0.24 per basic and diluted share, compared to a GAAP net loss of $12,154,596, or $0.27 per basic and diluted share, for the 2013 fiscal year. Excluding non-cash expense of $993,866 attributable to the change in fair value of liability-classified warrants, Non-GAAP1 net loss was $14,515,195, or $0.23 per basic and diluted share for the year endedDecember 31, 2014. In comparison, Non-GAAP1 net loss for the year ended December 31, 2013 was $10,264,237, or $0.23 per basic and diluted share, which excludes non-cash expense of $1,890,359 attributable to the change in fair value of liability-classified warrants.
For the quarter ended December 31, 2014, Catalyst reported a GAAP net loss of $3,490,030, or $0.05 per basic and diluted share, compared to a GAAP net loss of $1,354,658, or $0.03 per basic and diluted share, for the 2013 fiscal year. Excluding non-cash income of $472,026 attributable to the change in fair value of liability-classified warrants, Non-GAAP1 net loss was $3,962,056 or $0.06 per basic and diluted share for the fourth quarter of 2014. In comparison, Non-GAAP1 net loss for the fourth quarter of 2013 was $2,684,813, or $0.05 per basic and diluted share, which excludes non-cash income of $1,330,155 attributable to the change in fair value of liability-classified warrants.
Research and development expenses for the year ended December 31, 2014 were $10,117,774, compared to $8,096,774 for the 2013 fiscal year. For the fourth quarter of 2014, research and development expenses were $2,384,241, compared to $2,068,083 in the fourth quarter of 2013. Research and development expenses increased when compared to the same period in 2013 as Catalyst continued to incur expenses related to the Phase 3 trial evaluating Firdapse™ for the treatment of LEMS, costs related to the pre-clinical and clinical testing of both Firdapse™ and CPP-115, costs related to the launch and operation of the Firdapse™ Expanded Access Program and our share of the joint studies being conducted with BioMarin. Catalyst expects research and development expenses will increase in 2015, as we continue our currently planned research and development activities, including the completion of all testing required to submit an NDA for Firdapse™, costs relating to our currently anticipated submission of an NDA for Firdapse™ in the third quarter of 2015, costs relating to the operation of the Firdapse™ Expanded Access Program and costs related to the Phase 1b trial for CPP-115.
General and administrative expenses for the year ended December 31, 2014 totaled $4,473,654, compared to $2,214,884 in the 2013 fiscal year. For the fourth quarter of 2014, general and administrative expenses totaled $1,599,620, compared to $638,840 in the same period in 2013. The increase in general and administrative expenses from prior year consists mainly of increases in headcount, consulting and marketing expenses, as a result of our pre-commercialization efforts during 2014.
Catalyst had no revenues in the year 2014 or 2013.
At December 31, 2014, Catalyst had cash and cash equivalents, certificates of deposit and short-term investments of $39.3 million and no debt. Catalyst believes that its existing capital resources will be sufficient to support its planned operations through 2016.
More detailed financial information and analysis may be found in the Company’s Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 13, 2015. (Original Source)
Shares of Catalyst closed last Friday at $4.18 . CPRX has a 1-year high of $4.25 and a 1-year low of $1.70. The stock’s 50-day moving average is $3.64 and it’s 200-day moving average is $3.05.
On the ratings front, Catalyst has been the subject of a number of recent research reports. In a report issued on February 17, Piper Jaffray analyst Charles Duncan reiterated a Buy rating on CPRX, with a price target of $7, which implies an upside of 67.5% from current levels. Separately, on February 2, Roth Capital’s Scott Henry reiterated a Buy rating on the stock and has a price target of $6.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Charles Duncan and Scott Henry has a total average return of 15.2% and 36.2% respectively. Duncan has a success rate of 62.8% and is ranked 472 out of 3516 while Henry has a success rate of 69.5% and is ranked 22
Catalyst Pharmaceutical Partners, Inc. is a biopharmaceutical Company. It develops and commercializes prescription drugs targeting diseases of the central nervous system with a focus on the treatment of drug addiction and epilepsy.