Greetings and welcome to the Catalyst Pharmaceuticals Incorporated Third Quarter 2015 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. I’ll now turn the conference over to Ms. Ali Grande, Vice President, Chief Financial Officer and Treasurer. Thank you Ms. Grande, you may now begin.

Good morning and thank you for joining our conference call. To begin, on today's call, we have 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 2014 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.

Thanks, Ali. Good morning everyone and thank you for joining us today. I would like to welcome everyone to our third quarter results and update call. On today's call, I will give you an update on our activities and progress so far this year, including our recent NDA submission for Firdapse, as well as our pre-commercialization activities and infrastructure preparedness ahead of the potential FDA approval. Steve Miller will provide a status report of our pipeline and give scientific updates. Following, Ali will give a brief review of our financial results for the quarter. Lastly, we will take your questions. In July, we announced the initiation of a rolling submission of a new drug application to the FDA for Firdapse for the treatment of Lambert-Eaton myasthenic syndrome. We expect to complete the submission of the NDA during this quarter and will also be requesting a priority review of our application at that time. Given this time line, we hope to receive approval of our NDA in the third quarter of 2016. As part of our commitment to eligible patients we are providing access to Firdapse through our expanded access program. We also continue to maintain and expand positive relationship with important patient efficacy groups, including the Muscular Dystrophy Association, the National Organization of Rare Diseases and Global Genes. We recently announced the appointment of Paul J. Merrigan as Chief Commercial Officer. Mr. Merrigan is responsible for leading Catalyst marketing sales and commercial operations. Paul has extensive knowledge in the commercialization of novel therapeutics for orphan indications and specific knowledge in the commercialization of therapeutics per rare and neuromuscular disorders. Paul shares our passion to provide safe and effective therapies to patients suffering from rare diseases. With the addition of Paul to our management team, we are increasing efforts to build…

Thanks, Pat, and good morning everyone. As Pat previously stated, we are well underway with a project to develop a generic equivalent of Sabril or vigabatrin by its generic name. Sabril is marketed by Lundbeck in the United States for the treatment of infantile spasms and complex partial seizures. We have substantial previous experience with our version of vigabatrin, which we believe will contribute to the rapid development of a generic equivalent of Sabril. Over the last two years, we have already taken key steps that will contribute to the development of this project by developing and validating the manufacturing process, quality control procedures and stability test procedures, preparing commercial scale of batches and successfully conducting a bioequivalent study. We are nearing the completion of our Firdapse NDA submission and are also exploring additional indications, including congenital myasthenic syndromes or CMS and a sub group of Myasthenia Gravis patients that are zero positive for the MuSK antibodies. With regard to our development plans for CMS in addition to an investor sponsored IND, we have recently initiated a small blinded clinical trial in the pediatric CMS population ages 2 to 17. CMS is a rare neuromuscular disease comprising a spectrum of genetic defects and it is characterized by fatigable weakness of skeletal muscles with onset at or shortly after birth or early childhood, which in rare cases symptoms may not manifest themselves until later in childhood. CMS has estimated that one-tenth out of the Myasthenia Gravis population and we estimate that there are between 1000 and 1500 CMS patients in the United States. When the data from this new study is available we intend to amend our NDA filing with these data. We expect to complete this study by April of next year and at that time participants in the study may continue to receive Firdapse through our expanded access program. In this quarter, we also expect to announce top line results from a Phase 1b multiple dose safety and tolerance study for CPP-115. CPP-115 is being developed to treat infantile spasms, epilepsy and potentially Tourette's Disorder, as well as other neurological conditions associated with reduced GABAergic signaling. This Phase 1b trial is designed in two parts to evaluate the safety and tolerability of single and multiple doses of CPP-115, including CMS side effects and respiratory and cardiovascular safety. I will now turn the call over to Ali to review our financial results.

Thanks, Steve. For the quarter ended September 30, 2015 Catalyst reported a GAAP net loss of approximately $4.5 million or $0.05 per basic undiluted share, compared to a GAAP net loss for approximately $5 million or $0.07 per basic undiluted share for the same period in 2014. Excluding a non-cash gain of approximately $522,000 attributable to a change in fair value of liability-classified warrants, non-GAAP net loss was approximately $5 million or $0.06 per basic and diluted share for the third quarter of 2015. In comparison, the non-GAAP net loss for the third quarter of 2014 was approximately $4 million or $0.06 per basic and diluted share, which excludes non-cash expense of approximately $907,000 attributable to the change in fair value of liability-classified warrants. Research and development expenses for the third quarter of 2015 was approximately $3 million compared to an R&D spend of approximately $2.9 million in the third quarter of 2014. Research and development expenses increased when compared to the same period in 2014, as we increased activities related to our NDA filing for Firdapse and ongoing studies and trials and decreased activities related to our completed Phase 3 trial for Firdapse. We expect that our R&D spend for the rest of the year will increase as we prepare for and submit our NDA for Firdapse and as we increased activities in other ongoing studies and trials. General and administrative expenses for the third quarter of 2015 totaled approximately $2 million compared to approximately $1.2 million in the third quarter of 2014. The increase from period-to-period is primarily due to ramping up of our pre-commercial expenses and headcount as we prepare for the commercialization of Firdapse. As a development-stage biopharmaceutical company, Catalyst had no revenues in either the third quarter of 2015 or the third quarter of 2014. At September 30, 2015, Catalyst cash, cash equivalents, CVs and short-term investments of about approximately 63 million and no debt. This includes proceeds from our February 2015 offering in which we sold 11.5 million shares of common stock and raised net proceeds of approximately 34.9 million and the proceeds of warrants and stock option exercises during 2015. We believe that these resources should give us sufficient runway through our approval and subsequent product launch of Firdapse assuming these occur in 2016. More detailed financial information and analysis may be found in the company’s quarterly report on Form 10-Q which was filed with the Securities and Exchange Commission yesterday November 09, 2015 and can be found in the Investors Relations page of our website at www.catalystpharma.com. I’d now like to turn the call back to Pat.

Thanks, Ali. Before we answer your questions, I’m going to summarize our major goals and potential milestones looking at the coming months. Firdapse has demonstrated that it provides an important therapeutic benefit to LEMS patients along with potentially several other indications. We have initiated our rolling NDA submission to the FDA and we are continuing to work on a pathway that we hope will include certain types of CMS in the initial label Firdapse. We expect to complete the submission of the NDA this quarter and we’ll be requesting a priority review at that time. We continue to build out our commercial capabilities under the leadership of Paul Merrigan, our new Chief Commercial Officer who is advancing strategic, commercial development and preparing for the launch of Firdapse looking forward a potential NDA approval in the third quarter of 2016. Coming out of the recent AANEM meeting, I continue to be enthused about the support we are receiving from the physician community about the work that we are doing here at Catalyst to help serve the patient communities where LEMS, CMS and other unmet medical needs. We continue to expand and progress our pipeline by exploring additional indications for Firdapse and CPP-115 and also investigating new molecules for development within our area of expertise. Adding to our pipeline and portfolio remains a key focus for us while we advance Firdapse NDA submission. With that, I’d like to thank all of you for participation today and open up the call for questions.

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Our first question is from Charles Duncan of Piper Jaffray. Please go ahead.

Good morning, Pat and team. Thanks for taking my question and congratulations on a good quarter of progress.

Thank you, Charles.

I had a question about Firdapse in terms of that expanded access program. I’m wondering if you could share with us either the number of patients or if not the actual number of patients if participation is growing and if that’s in for patients without LEMS as well as CMS?

Charles, thanks for the question. As you know, we don’t talk about specific numbers for the expanded access program. We don’t want to have to continually update that every time we have a call with an investor or an analyst. So we – to have that policy in place since we started the program, we are pleased with the progress we are seeing. It is advancing nicely. We are seeing a pretty good mix of CMS patients compared to LEMS patients. So generally I think we are pleased with the program and I think more importantly the discussions that we are having with docs and meetings with patient organizations and actual patients, they are very pleased with the approach that we are taking and how easy it is for them to enroll in our program.

Okay. That’s helpful. And then I guess kind of a corollary to that is if Firdapse is approved, do you plan to have a patient access program in place or patience assistance program when the drug is approved?

The answer is, yes. We expect to have a patient assistance program. We are already and we’ve mentioned this previously, we are working with the patient organizations as well as NORD and we expect that all patients regardless of the economic status, we will have access to this drug.

Okay. That’s helpful. And then if I could transition over to CMS, I know that you have study ongoing. Can you provide us any additional insights on when you would anticipate timing of the - from this study?

Yes, let me turn that over to Steve.

Hello, Charles. With regard to the timing, we anticipate that we will have data in April which will be in time for the 120 day update for NDA.

Okay, good. Thanks for the added color.

Thank you. The next question is from Edward Nash with SunTrust Robinson Humphrey. Please go ahead.

Hi, good morning. Thanks for taking my question. I wanted to first ask now that you have achieved Commercial Officer on board, may be you could talk a little bit about what the plans are I guess from the size of the sales force standpoint that you are planning? And then I guess just for purposes of modeling just will you expect those first hirers to start occurring?

Okay. Edward, good morning.

Good morning.

As we had mentioned, with bringing Paul on board, we have started the build out of the infrastructure of the commercial side. We brought on David Caponera about a year ago. Dave came over from another rare disease company where he was VP of Patient Advocacy and in charge of Reimbursement. So a lot of those initiatives are underway on the efficacy, dealing and talking to payers. And your question about the size of the sales force, we are doing our sales force sizing work right now but we are modeling 15 to 20 sales reps with a five or so [indiscernible]. There are about 900 neuromuscular specialist and we feel though we can reach that - effectively reach that market with these 15 to 20 sales reps in [indiscernible] P7 (3:48). And those will be brought on, the playing right now is to bring those on in two ways, the sales reps will come on about half of those will come on in Q1 and the other half will come on in Q2 as we approach anticipated launch.

Great, that’s helpful. And then I just had one other question with Steve. He mentioned that roughly about 1,000 to 1,500 CMS patients in the U.S. Are those patients that – is that a calculated epidemiologic number or are these patients already identified that are actually maybe some type of registry out there that we know that those patients are out there and eligible for treatment?

There is not a registry for these patients. That number is an estimate based on the opinions and observations of a large number of key opinion leaders and based on quite a bit of literature that’s been published on the disease.

Great. Thanks so much guys. Appreciate it.

Thank you, Ed.

Thank you. The next question is from Scott Henry of ROTH Capital. Please go ahead.

Thank you and good morning. Just a couple of question.

Good morning, Scott.

Starting on the income statement, you’ve spent G&A and selling in third quarter of 15, where there any selling costs or material amount that took place pre-selling or anything you could classify in that category?

Yes. As Ali pointed out, the expenses on G&A moved from $1.2 million to $2 million for SG&A and about $800,000 of that was related to pre-commercialization activities. And as you can imagine, Scott, those numbers are going to accelerate as we move towards launch.

Okay. Thank you. That’s helpful. And then shifting gears over to the generic vigabatrin, when would you expect that you could possibly file an ANDA. You may not want to give a lot of color on that but is it unreasonable to think that this could be a 2016 event?

You are right. We don’t want to add any color to that and as you probably know, most generic drug companies are very stealth with regard to joints that are being developed and anticipated approval dates. So Scott, we are going to remain pretty silent on that. The word out of us hopefully will be an approved ANDA. And so…

Okay. So you will not disclose when you file it? You will just disclose when it’s approved.

Correct. Yes.

Perfect. Okay certainly fair enough. And then I guess just a final question, I wanted to make sure I have this correct. The pediatric trial with CMS, we should get data in second quarter of 2016?

Correct.

Okay. And will you just press release that data or how should we expect that?

Yes. We will certainly advise in public on the results of that study.

Okay. Perfect. Thank you for taking the questions.

Okay, Scott. Thank you.

Thank you.

Thank you. The next question is from Charles Duncan of Piper Jaffray. Please go ahead.

Thanks guys for taking the follow-up. I have a question regarding the regulatory process for Firdapse. Understand that it’s been granted Breakthrough Therapy Designation, can you let us know if you’ve been having regular or have had regulatory input on the process recently. And then I think you also mentioned that you would request priority review upon the completion of the NDA filing. Could you tell us what you think would be the trigger for that being given as well.

We’ve been advised by our regulatory council that most all of the Breakthrough Therapy Designations have gotten a priority review and I know why this would be any different. And actually Breakthrough Therapy Designations are actually getting approved in the little over five months and I think maybe that’s an internal thing of the FDA. So you have to request it and we hope it will get that, Charles.

Okay. And then you have had some pretty regular interactions with the agency?

Yes. We continue to have dialogue either telephonically or via e-mail. So that’s one of the major advantages I think a breakthrough is access to senior people within the division.

In addition to that because we are doing a rolling submission, each module that gets submitted has a cover letter that goes in with not only information about the presumable unit but any issues that we want to according to the FDA submission.

And then if you could just clarify, is the entire NDA reviewed for administration or administratively reviewed at the end or is each module reviewed as you submit it in terms of reviewability if you will?

The FDA has the opportunity to review each reviewable unit as it is submitted, there is no way of knowing whether or not that review has actually taken place. The FDA will not communicate comments regarding the NDA to an applicant until after the full NDA has been received regardless of whether they are reviewing it early or not. When we complete the last module submission this quarter, the NDA undergoes a review for acceptance and within 60 days will then notify our acceptance of the NDA and that’s when all of the formal communication starts between the FDA and the applicant.

Okay, that’s helpful. And then one additional question in terms of Myasthenia Gravis, perhaps I’m wondering what your thinking is now on that potential use of Firdapse if anything?

We are in the process of initiating a trial to evaluate those patients as I pointed out in our earlier discussion and we will provide additional details once that study is underway.

Okay. Thanks for the added color.

Thank you, Charles.

Thank you. And with that, I’d like to turn the conference back over to management for additional comments.

Okay. Thanks again for tuning into today’s call. I’m clearly excited about the progress we’ve made on both the clinical front advancing our pipeline as well as our regulatory and market preparing the steps that we’ve taken with Firdapse, they have the potential launch next year and we thank you for your support. Have a nice day.

Thank you. Ladies and gentlemen, this does conclude today’s teleconference. You may disconnect your lines at this time and thank you for your participation.