Greetings and welcome to the Catalyst Pharmaceuticals First Quarter 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 pleasure to introduce your host Ali Grande, Vice President, CFO and Treasurer. Please go ahead, Ms. Grande.

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 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.

Thanks Ali. Good morning, everyone and thank you for joining us today. I'd like to welcome everyone to our first quarter results and update call. On today's call, I will give you a report on our activities and progress so far this year, including the regulatory status Firdapse, and rest of our development pipeline. Steve Miller will provide a more detailed status report on our pipeline and next steps for Firdapse. Following, Ali will give a brief review of our financial results for the quarter. Lastly, we will take your questions. We recently provided an update on the content of the planned resubmission of the New Drug Application for Firdapse, which currently has Breakthrough Therapy and Orphan Drug designations for Lambert-Eaton myasthenic syndrome. We have obtained clarity from the FDA on what will be required for the agency to accept the Firdapse NDA for filing. The FDA has stated that in addition to the positive results of the submitted multi-center, randomized, placebo-controlled, Phase 3 LMS-002 trial, that we successfully completed in 2014, Catalyst will need to submit positive results from an additional adequate and well-controlled study in patients with LEMS. The FDA has also stated that it is open to discuss a study design that could efficiently accomplish the requirement with a small, short-term study and we are currently in discussions with the FDA and with our clinical experts regarding the protocol and logistics for this confirmatory study. Additionally, there is a requirement for several more short-term toxicology studies, which are expected to start soon. While we are disappointed by this new request from the FDA for an additional Phase 3 study, we are encouraged that we have clarity on the regulatory pathway moving towards bringing Firdapse to market for patients suffering with LEMS and congenital myasthenic syndrome. Catalyst is committed to working with the FDA on developing a clinical study designed that will meet the requirements for approval. Once we've agreed on the study design with the FDA, we will provide an update on our regulatory path. We believe that this regulatory requirement from the NDA – from the FDA establishes a higher standard that will have to be met for a successful NDA submission. As always, we remain committed to LEMS and CMS patients with our continued research and our expanded access program, which continues to enroll new patients and provide Firdapse at no charge to eligible patients. While we have delay on Firdapse reaching the market, we continue to advance our pipeline of other drugs for unmet medical needs. Our overall goal for becoming a rare disease focused commercial stage bio pharmaceutical company remains in place. I'll now turn the call over to Dr. Steve Miller, who will provide updates on our pipeline and scientific developments.

Thanks, Pat and good morning, everyone. As Pat previously stated, we are currently working with the FDA to resolve issues with our NDA submission of Firdapse for the treatment Lambert-Eaton myasthenic syndrome and congenital myasthenic syndromes. Both of these diseases are ultra rare with prevalences in the United States believed to be approximately 3,000 and 1,000 to 1,500 patients respectively. We believe that the agency is open an efficient small, short term study design for a confirmatory clinical study for Firdapse and we are currently in discussions with the FDA and our clinical experts on a suitable study design. We are also continuing the development of Firdapse for additional indications and recently announced the initiation of an investigator sponsored study of Firdapse in patients with the MuSK-Antibody Positive Myasthenia Gravis. Furthermore we also continue to enroll patients in our ongoing CMS trial. Well, so our focus remains on clarifying our pathway for Firdapse, Catalyst is maintaining its development of other products in our pipeline and subject to the availability of funding CPP-115 is moving towards Phase 2 readiness, including a Phase 1 dose ranging study evaluating CPP-115 at lower doses. We also continue to make progress with the development of our generic equivalent of Sabril. I will now turn the call over Ali, to review our financial results.

Thanks, Steve. For both the quarter ended March 31, 2016 and the quarter ended March 31, 2015, Catalyst reported a GAAP net loss of $5.4 million or $0.07 per basic and diluted share, excluding non-cash gain of 733,000 attributable to the change in fair value of liability-classified warrants. Non-GAAP net loss was $6.1 million or $0.07 per basic and diluted share for the first quarter of 2016. In comparison, non-GAAP net loss for the first quarter of 2015 was $4.2 million or $0.06 per basic and diluted share, which excludes a non-cash expense of $1.2 million attributable to the change in fair value of liability-classified warrants. Research and development expenses for the first quarter of 2016 were $3.5 million compared to $2.3 million in the first quarter of 2015. This increase in research and development expenses is primarily due to consulting on regulatory matters, activities related to our Firdapse expanded access program, including manufacturing of the related drug, and increased activities in other ongoing studies and trials. General and administrative expenses for the first quarter of 2016 totaled $2.7 million compared to $1.9 million in the first quarter of 2015. The increase when compared to the same quarter in 2015 is primarily due to an increase in pre-commercialization expenses, payroll and benefit expenses. As a development-stage specialty pharmaceutical company, Catalyst had no revenues in either the first quarter of 2016 or the first quarter of 2015. As of March 31, 2016, Catalyst had cash and investments of approximately $52.5 million and no debt. We believe that these resources give us sufficient runway for at least the next year. However, until the details and logistics of the required confirmatory study evaluating Firdapse for the treatment of LEMS are finalized, we cannot provide more details regarding how far our existing resources will take us. Notwithstanding, and while there can be no assurance, we continue to believe that our currently available resources will be sufficient to complete the development of Firdapse and refile an NDA for Firdapse. More detailed financial information and analysis may be found in the company's quarterly report on Form 10-Q, which was filed yesterday May 10, 2016 with the Securities and Exchange Commission and can be found on the Investors Relation page of our website at www.catalystpharma.com. Now, I would like to turn the call back to Pat.

Thanks, Ali. Firdapse has demonstrated that it provides an important therapeutic benefit to LEMS and CMS patients and possibly for several other neuromuscular indications. And we remain confident in its potential approval and future launch. While we are disappointed with the requirement for an additional Phase 3 trial, we are focused on working with the FDA to develop a new study design and initiate the study as soon as possible. We appreciate the working relationship with the FDA and hope to complete all required studies efficiently and swiftly in order to complete our Firdapse NDA submission in a timely manner. As we have worked with the LEMS patient communities and physicians treating them, we have only become more convinced of the need for Firdapse and the hope it can bring to many. We expect to advance our scientific pipeline and continue our work with rare disease organizations to help increase awareness of LEMS and CMS and to provide support and education for the physicians and the patients that they treat. We are currently reevaluating our operational plan to ensure as best as possible that we have sufficient financial resources to complete the additional studies required and completing our filing in NDA without the need for additional financing. With that, I'd like to thank all of you for participating today and open up the call for questions.

Thank you. [Operator Instructions] Our first question today is coming from Charles Duncan from Piper Jaffray. Please proceed with your question. Charles Duncan Good morning. This is Sarah on for Charles. I just had two questions. So for the second LEMS trial, I know you are still nearly to offer [ph] design, but do you think the second Phase 3 could look similar to the first one and are you fairly certain that will start in the second half? Pat McEnany Hi, Sarah, good morning. Thanks for your question. It’s a great question. We are not prepared to talk about what the study design and the endpoints will look like at this point. And so we have final understanding or agreement with the agency and so when we have that we'll certainly be prepared to come forward and present more of the details and we hope to have that sometime before the end of this quarter. And yes, we feel confident that we'll start the study - to your question, in the second half of this year. Charles Duncan Okay. Thanks. And then my second question is just about the CMS pilot, so when you say that trial is still enrolling, is that - I think it was 10 patients cohort? Pat McEnany Right. Charles Duncan Okay. Are you considering expanding that trial at all, or should we still expect results at some point in the next couple of months? Pat McEnany That’s a good question, and we've had discussions with the agency and that was in fact - and that we refuse to file letter, there were some points to be made there. And we believe that we have clarity, but until we have finalized the study design for LEMS, we're not really prepared to talk more about CMS, other than we continue to enroll new patients and we're not sure yet what the final end may look like, but for the moment the plan is still to have an amount of 10, around 10. Charles Duncan Great. Thanks so much. Pat McEnany Thank you.

Thank you. Our next question today is coming from Scott Henry from ROTH Capital. Please proceed with your question. Scott Henry Thank you. And good morning, gentlemen. Pat McEnany Morning, Scott. Scott Henry Couple of questions, for starters, what would you estimate the selling expenses were and kind of pre-marketing in Q1 and more importantly should we expect those – will they go to zero, or will – what will be your base pre-marketing expenses going forward, as they try to get a handle on the G&A line? Pat McEnany Yes. Scott, we're - again, we're not prepared to talk about that today. We are evaluating our operational plan, it’s a very good question. We are looking at all of our cost centers in addition to commercial, we're looking at R&D and we're looking at G&A. And we'll be fine tuning that over the next year and we will – once we have a better understanding of what our operational plan going forward looks like, which by the way will be tied to a great extent by what are the endpoints and the protocol for the LEMS Phase 3 study looks like. So, we're evaluating our entire business model, and I think we can add a greater clarity over the next four to six weeks. Scott Henry Okay. Fair enough. And then another question, just with regards to the profess of moving forward with the second Firdapse trial, approximately when should we expect an update, is there an FDA meeting or is there any clarity on what the next step that we will hear about will be? Pat McEnany Yes, I think Scott, once we come to agreement on what the design and the protocol look like, which we hope that it will happen before the end of this quarter, at that time we will probably have an analyst call and or a shareholders call to discuss our path forward. It’s just a little premature. There is ongoing dialogue with the agency and I think that it will be premature at this point to talk about it. Scott Henry Okay. Fair enough. Pat, thank you for taking the questions. Pat McEnany Thank you.

Thank you. [Operator Instructions] Our next question today is coming from Edward Nash from SunTrust. Please proceed with your question. Yun Zhong Hi. This is Yun for Edward. Good morning. Thank you for taking the questions. A couple of questions, and the first one is, I wonder if you are able to comment on what was the most important piece of information missing from the original NDA submission that led the FDA wanted another second Phase 3 study. And related to that question, and how much information from the post-marketing data from BioMarin did you include in the original NDA package? Pat McEnany Good morning, Yun. Your first question with regard to what was the most significant missing piece, I am not sure that we can answer that. But there was a significant piece that was not provided. It became very clear after the receipt of the RTF that the FDA was going to hold us to the statutory standards which are to adequate and well-controlled studies. And so there is a lot of speculation as to why and I am not going to get into that, but we thought that when we filed the NDA we thought that we had a very complete package based on historical discussions and we were blown over when we got the RTF letter as you know. So I can't comment, I am not sure I can answer your question about it, what particular piece might have been missing. Yun Zhong Okay. And about the post-marketing data? Pat McEnany Well, there was a registry in Europe which we referred to and is part of our NDA and I am not sure there is more that I can add, other than - and that was included in the NDA and I think clearly, based on…

Thank you. We've reached end of our question-and-answer session. I could turn the floor back over to management for any further closing comments.

Thanks again for participation on this call. I'd once again, like to thank all our stakeholders for their support in helping Catalyst deliver on its promise to advance the treatments for patients suffering from rare unmet needs. We look forward to seeing some of you at upcoming investor conferences and we hope to provide more guidance as additional facts become available. We certainly appreciate your patience and promise you we will work tirelessly to move forward with our shared vision. Thank you.

Thank you. That does conclude today's teleconference. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.