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Catalyst Pharmaceuticals, Inc. (CPRX)

Q4 2016 Earnings Call· Thu, Mar 16, 2017

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Transcript

Operator

Operator

Greetings and welcome to the Catalyst Pharmaceutical Partners, Inc. Fourth Quarter and Fiscal Year end 2016 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host Ms. Ali Grande, Chief Financial Officer with Catalyst. Thank you. You may begin.

Alicia Grande

Analyst

Good morning and thank you for joining our conference call. To begin, on today’s call we’ve Pat McEnany, Chairman and Chief Executive Officer; and Dr. Steven Miller, Chief Operating Officer and Chief Scientific Officer. On this call, we will be making forward-looking statements involving 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 those described in Catalyst's Annual Report on Form 10-K for the fiscal year 2015 and its other filings with the U.S. Securities and Exchange Commission could adversely affect Catalyst. All forward-looking statements are qualified in their entirety by these cautionary statements and Catalyst undertakes no obligation to revise or update this presentation to reflect events or circumstances after the date hereof. At this time, it is my pleasure to turn the call over to Pat McEnany, our Chief Executive Officer.

Patrick McEnany

Analyst

Thanks, Ali, and good morning, everybody. Thank you all for joining the call today. I'd like to welcome everyone to our fourth quarter and year end results call. On today's call, I’ll discuss our 2016 performance and will also report on the status and progress of our current activities. Steve Miller will provide a more detailed status report on our pipeline and next steps for Firdapse. Following, Ali will give you a brief review of our financial results for the quarter. At the conclusion of our prepared remarks, we will open the call for questions. Also joining us on today’s call is Dr. Gary Ingenito, our Chief Medical Officer. Gary will be available to address questions on the clinical and regulatory front. Gary will be an integral part of all of our future conference calls. As we embark on 2017, we do with the excitement and intense focus. This is a year that we expect to achieve many of our clinical and regulatory milestones and move a step closer to launching our first medicine with the completion of our pivotal studies for LEMS and CMS and the planned submission of our NDA for Firdapse. As we’ve previously stated, our new NDA submission will incorporate a substantial body of data that not only will include two Phase 3 clinical trials, and several other clinical safety studies, but many other non-clinical studies totaling more than 65 trials or studies that have been conducted by Catalyst for BioMarin. This will be a robust filing package, especially for an orphan drug program. In December 2016, we are pleased to enroll the first patient into our second Phase 3 clinical trial designated as LMS-003 to evaluate the efficacy and safety of Firdapse, amifampridine phosphate in patients with Lambert-Eaton Myasthenic syndrome. After working with the FDA…

Steven Miller

Analyst

Thanks, Pat, and good morning, everyone. As Pat previously stated, we announced yesterday the positive results of the investigator sponsored proof-of-concept trial for the symptomatic treatment of MuSK-Myasthenia Gravis, which is a subtype of myasthenia gravis the affects about 4,500 patients in the U.S. Statistical significance was achieved from both of the co-primary endpoints quantitative myasthenia gravis or QMG and myasthenia gravis activities of daily living or MG-ADL with P values of 0.0003 and 0.0006, respectively. Most importantly, a large benefit -- beneficial clinical effect was also observed during treatment with amifampridine phosphate and the treatment was well-tolerated by the patients. Dr. Mantegazza or other key members of his research team are planning on presenting the outcome data from this trial at upcoming medical conferences initially with a possible presentation of a hot topic short talk at the 13th International Conference on myasthenia gravis and related disorders in May, as well as also publishing these results in the near future. They will present the primary endpoint results as well as the results of a number of other secondary clinical endpoints that were also assessed in this clinical trial including the myasthenia gravis composite score, the myasthenia gravis quality-of-life score, the fatigability severity score, the Neurological Institute Carlo Besta Myasthenia Gravis Score and two responder analysis. Statistical significance was reached for most of these secondary endpoints as well, Catalyst provided funding, test drug, and matching placebo for this clinical trial. Additionally, Catalyst funding included the use of a CRO to provide a technical writing, monitoring, statistical services, blinded randomization and oversight of the trial so that it could be conducted as a well-controlled clinical trial suitable for use in regulatory submissions. This form of myasthenia gravis is caused by an antibody to the MuSK protein, which is responsible for maintenance of…

Alicia Grande

Analyst

Thanks, Steve. Yesterday we reported a GAAP net loss of $18.1 million or $0.22 per basic and diluted share for the 12 months ended December 31, 2016, which compared to a GAAP net loss of $20.2 million or $0.25 per basic and diluted share for the period -- for the same period in 2015. Excluding non-cash gain of $886,000 attributable to the change in fair value of liability-classified warrants, Non-GAAP1 net loss was $19 million or $0.23 per basic and diluted share for the year 2016. In comparison, 2015 non-GAAP net loss was $20.3 million, or $0.25 per basic and diluted share, which excludes a non-cash gain of $65,000 attributable to the change in fair value of liability-classified warrants. For the first quarter of 2016, we reported a GAAP net loss of $4.2 million, or $0.05 per basic and diluted share compared to a GAAP net loss of $5.8 million or $0.07 per basic and diluted share for the same period in 2015. Excluding non-GAAP gain of $107,000 for the change in fair value of a liability-classified warrants, non-GAAP net loss was $4.3 million or $0.05 per basic and diluted share for the fourth quarter of 2016 in comparison to non-GAAP net loss for the fourth quarter of 2015 was $6.2 million or $0.07 per basic and diluted share and excluded non-cash gains of $300,000 attributable to this change in fair value of liability-classified warrants. Research and development expenses were $2.8 million, and $11.4 million for the fourth quarter and full-year 2016, respectively compared to an R&D spend of $3.8 million and $11.8 million in the fourth quarter and full-year of 2015. Research and development expenses decreased when compared to the same period in 2015, primarily due to our continued activities related to ongoing studies and trials for Firdapse, including…

Patrick McEnany

Analyst

Thanks, Ali. We are encouraged by our recent progress and pleased to have recently initiated our second Phase 3 trial for Firdapse in LEMS patients. We believe we now have the clear path for towards an approval and look forward to updating everyone as the trial progresses and reporting data later this year. With that, I’d like to thank all of you for participating today and open-up the call for questions.

Operator

Operator

Q - A -

Patrick McEnany

Analyst

I’d like to thank you for joining us on today’s call. We look forward to keeping you advised on our progress. Thank you.

Operator

Operator

Ladies and gentlemen, today’s conference has concluded. You may disconnect your lines at this time, and have a wonderful day.