Greetings and welcome to the Catalyst Pharmaceuticals Incorporated Second Quarter 2021 Results. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Ms. Ali Grande, Chief Financial Officer. Thank you. You may begin.

Good morning, everyone and thank you for joining our conference call to discuss Catalyst’s second quarter 2021 financial results and corporate highlights. Leading the call today, we have Patrick McEnany, Chairman and Chief Executive Officer. We are joined by Dr. Steven Miller, Chief Operating Officer and Chief Scientific Officer and Jeffrey Del Carmen, Chief Commercial Officer. For the Q&A session, we will also have Dr. Gary Ingenito, Chief Medical and Regulatory Officer. Before we begin, I would like to remind you that in the following comments and in the Q&A session, we will make statements about expected future results which maybe forward-looking statements for purposes of federal securities laws. These statements relate to our current expectations, estimates and projections and are not guarantees of future performance. They involve risks, uncertainties and assumptions that are difficult to predict and may prove not to be accurate, especially in light of the effects of COVID-19. Actual results may vary. These forward-looking statements should be considered only in conjunction with the detailed information contained in our SEC filings, including the risk factors described in our 2020 Annual Report on the Form 10-K. At this time, I will turn the call over to Pat.

Thank you, Ali and thanks, everyone for joining us this morning for our second quarter 2021 results in corporate update call. I hope that everyone is doing well and staying safe and healthy during these unusual times. We are very proud of the results that we achieved during this past quarter. Total net revenues were $36.4 million, up 23% over the same quarter last year. During the second quarter, we completed the agreement with DyDo Pharma for the rights to develop and commercialize Firdapse in Japan, which contributed $2.7 million in revenue. Further, net Firdapse product revenues for 2021 second quarter were $33.6 million, up 14% from net product revenues of $29.6 million for the second quarter of 2020. GAAP net income before income taxes for the past quarter was $15.9 million compared to $10.4 million in the same quarter last year. GAAP net income after taxes was $12.2 million or $0.12 per share or $0.11 per share fully diluted compared to $9.8 million or $0.09 per basic and diluted share in the second quarter of 2020. Additionally, we ended the second quarter of this year with $155.3 million in cash and short-term investments. Reported cash and short-term investments this quarter was impacted by $3.7 million invested in our open market share repurchase program. As you may recall, very late in the first quarter of this year, our Board of Directors approved a share repurchase program of up to $40 million of Catalyst shares from the open market. And as of today, the company has repurchased in the open market approximately 1 million shares of common stock at an average purchase price of $5.06 per share for a total of $5.1 million. We continue to believe that rationale purchases of our shares in the open market is prudent and increasing…

Thanks, Pat and good morning, everyone. We are very pleased with Q2 net Firdapse sales of $33.6 million, which represents 14% growth for the quarter versus the same quarter last year and 11% growth versus Q1 2021. I want to take this opportunity to thank the entire Catalyst organization for their resilience and continued focus on helping all adult LEMS stations. Strong net revenue in Q2 was driven primarily by steady new patient enrollments, continued favorable reimbursement dynamics, and stable discontinuation rates. Q2 new patient enrollments were 111% higher for the quarter versus the same quarter last year. In the first half of 2021, new naïve to 3,4-DAP patient enrollments were 42% higher than the first half of 2020. Our strong patient persistency resulted in continued low 90-day discontinuation rates of less than 15%. Through the first half of 2021, discontinuations were 25% lower than the first half of 2020. We continue to see a gradual recovery from the impacts of the COVID-19 pandemic in Q2 when compared to Q1 2021. Patient visits and lab test procedure trends continue to improve, but remained below pre-COVID-19 levels. Through June, IQVIA COVID-19 market impact data suggests that diagnostic visits specific to neurology are 15% less than pre-pandemic levels. However, we have a robust pipeline of patient leads that are already diagnosed with LEMS, but not yet on therapy. Many of these patients are waiting to visit with their physician. I am extremely pleased with our Q2 execution. Given the sustained impact of COVID-19 on our business, commercial field activity remains strong. Combined efforts between our commercial field force, non-personal promotion and inside sales enabled efficient coverage of approximately 20,000 healthcare providers. In-person interactions accounted for 50% of activity, which represents a twofold increase quarter-over-quarter. We will continue to closely monitor the course…

Thanks for the commercial update, Jeff. I’ll now provide an update on our clinical pipeline and our development efforts for Firdapse. As you know, we are developing a long-acting formulation of amifampridine phosphate in order to provide patients with a more convenient dosing regimen and a more consistent therapeutic effect. A number of candidate formulations have been prepared, and three of the most promising formulations were evaluated in a pharmacokinetic called PK study completed in the fourth quarter of 2020. The results of this first PK study are being used to inform the design and refinement of additional product formulations now under development and an additional PK study will be conducted later this year. We have also completed a number of advisory panel meetings with both patients and physicians in order to establish the optimum target characteristics of the long-acting formulation of amifampridine phosphate that are desired by the LEMS patient community and treating physicians. As previously announced, Catalyst submitted our plans, including the protocol for a new clinical trial for the symptomatic treatment of MuSK Myasthenia Gravis, or MuSK-MG, to the FDA for their review and comment. The FDA provided written comments that question suitability of both the revised study design and the ability of the initial MuSK-MG pilot study to be supportive. Therefore, we can’t rule out the possibility that a single study similar in design to MSK-002 would not be sufficient for potential approval of the MuSK indication. Based on the positive reports from physicians and patients that participated in our previous studies, we are planning to convene an expert panel to discuss the options and review a likelihood of success for a MuSK-MG indication for Firdapse. Upon completion of this expert review, Catalyst will update the investment community on our determination as to whether to continue…

Thanks, Steve. Yesterday, we filed 2021 Form 10-Q to the SEC and reported our second quarter financial reports in our press release. We are very pleased with our financial results for the second quarter. Let me highlight a few of those results now. As reported, we ended the quarter with cash and investments of $155.3 million and no funded debt, which we believe will enable us to advance our R&D programs and support our strategic initiatives of acquiring earlier stage opportunities and innovative technologies to enable growth and value creation. Total net revenues for the second quarter of 2021 was $36.4 million, a 23% increase when compared to total revenue of $29.6 million for the second quarter of 2020. 2021 total revenues included $2.7 million of proxies related to our license agreement with DyDo for Japanese development and commercialization rights. Our second quarter sales continued to be impacted by the pandemic although, as Jeff mentioned, we continue to see rail recoveries. Despite these challenges, total Firdapse product revenue net were $33.6 million for the second quarter of 2021, 14% higher than net product revenue was 29.6% for the second quarter in 2020. As Steven just mentioned, we are optimistic about our revenue growth in 2021 as hopefully the effect of the COVID-19 pandemic subsides. We reported GAAP net income of $12.2 million for Q2 2021 or $0.12 per basic $0.11 per diluted share, 24% increase when compared to GAAP net income of $9.8 million or $0.09 per basic and diluted share for Q2 2020. Before I continue, let me take a moment to provide more color on our second quarter tax rate. Our effective tax rate in the second quarter of 2021 on an underlying basis was 22% as compared to 5.7% in the second quarter of 2020. The tax…

Jeff, Steve, Ali, thank you for your reports. I’d like to close on our prepared remarks by making this segment to the entire Catalyst team in thanking them for dedication and continued patient focus version during these challenging times to ensure that all LEMS patients have affordable access to Firdapse. I’ll now turn the call over to the operator, so that we may take your questions.

Thank you. Our first question comes from Charles Duncan with Cantor Fitzgerald. Please proceed.

Yes. Hi, Pat and team, congratulations on a good quarter. And thank you for taking question. First question is on Firdapse commercial, second is on pipeline and third is on strategy. And so regarding the first question, I guess I’m wondering if Jeff could provide some additional color on the effectiveness of the patient resources to shorten the diagnostic journey that he mentioned, particularly interested in the diagnosed versus prevalence assumptions that you’re making? How are you shortening this diagnostic journey? And then also be interested in whether or not you want to provide Firdapse revenue guidance. I’m not sure if Ali said that, I got to tell you, there’s a lot of background noise. And so I’m not sure if I heard all of our comments on guidance?

Yes, Charles. Yes, they are – we are not providing any guidance yet. Thank you for your questions, by the way. We still think that we need to monitor what’s happening with COVID before we are able to provide any guidance at this point. So, you know that our policy is, at this point, no guidance. And with regard to our shortening the diagnostic journey, I will let Jeff answer that versus the prevalence as we both mentioned in our remarks, it is a little bit more difficult these days. We have tools in place to shorten that journey. But the real issue is at the physician’s offices were alarmed, they were not fully functional at this point or they were not checking new patients, or they are requiring several in-person visits, before they will prescribe a new medication. So, those are some of the dynamics that we are dealing with and one of the reasons why we are at this point, unwilling to provide a revenue guidance. So, Jeff, do you want to talk about the diagnostic journey and the tools we are using.

Sure, and thanks for the question, Charles. First and foremost, we are very confident in the prevalence. We always stated that about 3,000 patients, adults with LEMS. And we – I strongly believe that it is our responsibility is manufacturing at ultra-rare disease, to provide patient educational resources and also educate our other potential stakeholders, physicians. With that, we are providing educational resources that are – it’s about LEMS, about some of the symptoms that these patients may be having, as well as pointing these patients to a free test that we have for LEMS reads VGCC test. But it’s a lot of information that they can take, discuss with their caregiver, and also bring into the physicians. So, that’s an extremely helpful for these patients. As a reference, we have 1,900 patients or caregivers that have opted. And with that – those options, we are allowed to engage with the stakeholders and provide the information that they request, and then have ongoing conversations with these patients. So, hopefully that helps address your question as to what we are doing with these patients, Charles.

Yes. I wanted to add to Jeff, to that Charles. We have an effort on the healthcare providers side, and education of – as Steve pointed out, we have two programs that are ongoing as we speak. One is continuing medical education credits that are available to docs, which we are hosting through Medscape. And I believe that we have about 1,500 unique docs who have signed up for this review. And I think 400 or 500 at this point have actually received credits for studying about LEMS, the disease and the – some of the therapies that were used to treat this particular disease. So, we have a – and then we have our Ambassadors Program, which is for neuromuscular specialists or fellows rather, at various academic institutions around the country, who we educate about LEMS. And they go back to their institutions. And they are supposed to go back and hold meetings with about another 15 or so of their colleagues at their institution to further spread the knowledge base around the disease, Lambert-Eaton Myasthenic Syndrome. So, there is not only the program for patients, but we do have programs for healthcare providers to educate them and we think that all of these combined really will help shorten the journey for patients to a definitive diagnosis and ultimately to affect the treatment.

Correct and another thing is, we have already seen Charles, patients that have reported that they bring up LEMS to the physician, to their physician is something that they may have based on the information that they are provided. So, we have seen traction there, from the patient and physician engagement. And the last thing I am going to add to this is we have both branded and unbranded videos that are offered on our websites that are maybe helpful to patients and caregivers as well. So, a lot of resources out there to help these patients.

Okay. It seems value added for the community. And I appreciate all the color. My next question was pipeline, sorry for taking so much time. And that is, perhaps for Steve, regarding the long acting form. I am wondering, it sounds like you are doing or did some PK studies and doing another one? Can you provide any additional color on the timing, because it seems like you are getting traction in the market with the non-long acting form of Firdapse. And I am wondering how much is this needed or if so, is this a nice to have or a need to have in terms of the franchise?

Thanks for the question. We actually have had a number of patients tell us that this is really a need to have. Many patients really don’t like the inconvenience of having to stop what they are doing and time when they are going to take their doses of amifampridine throughout the day. And so they really want this drug. Now, as you pointed out, we have done very well with sales, and it’s growing. And that basically points to the overall effectiveness of the message itself. And so it’s only going to get better for the patients when the sustain released version of the product becomes available.

Any thoughts on timing? I know there is a reason, perhaps competitive or whatever, to not give all that disclosed. But on the broad…?

From a broad point of view, we have about another year or so formulation work to do. At which point we basically will start appropriate clinical trials to support the enhanced efficacy of this product relative to the IR version of the product. We anticipate bringing this product to market before our orphan drug exclusivity expires.

Okay, great and that’s helpful. And then last question on strategy. Pat, you mentioned some hires, and going into a transformative period for the company in terms of executing strategy with regard to acquisition of products, platforms, or companies. And I guess I am wondering, what do you favor, is this kind of acquisition that you are looking for something that can tuck in within a very effective commercial sales effort at this point or does it take it in a different direction? Are you focused more on leveraging your experience within orphan neurology? Can you provide additional updates or additional color on your strategy there?

Sure Charles, yes, ideally, we would love to be able to leverage or sales force with another neuromuscular product in the bag. And we have tried that most of last year. We had a couple of attempts, which unfortunately, did not work out. And I think it’s a bit restrictive, we are going to grow our business. And it may not be in neuromuscular. And I think we described on our last call that we would – we are interested in expanding the spectrum to include just about any therapeutic category outside of oncology, which is very crowded, and a very difficult space to work in. So, I knew it’s going to be something that we think has a high likelihood of success and something that is affordable to us. We – let me use an example of endocrinology, which we looked at a potential asset about a year ago. That’s certainly not a product that would be carried in the bag by our neuromuscular sales team. We really think that we have done such a great job and our sales and marketing team has done a great job in bringing products to market that we can replicate that in other therapeutic categories like endocrinology for example. And put together a 15 to 20 person sales force or regional account managers to bring a product outside of neuromuscular to market. But we also think that clearly we want to stay in the rare disease space. And so again, the only thing that we are avoiding is obviously something that is too big a bite for us. And something that is an oncology, so it’s fairly broad approach. Ideally, with an acquisition, we would like to think that a validated technology platform came with that that may or may not be the case. There are some interesting small molecules out there, biologics as well as cell and gene therapy projects. So, we have got a fairly broad spectrum to look at, in various stages of development.

That’s helpful. What do you think about financing it in terms of debt versus equity? What kind of transaction are you contemplating?

Well, we think that our equity is awfully cheap. And I guess what a CEO doesn’t think that. But so, we – as we have pointed out, we have $155 million in cash, as of 6/30, that cash is growing by $10 million to $15 million per quarter. We know that we have access to probably at least $100 million in debt, term loans, a number of large banks, as well as some of the more takes have come to us and talk to us about taking on debt. We have been reluctant in the past, but it may be a good instrument to use to, to make an acquisition with it.

Maybe cheap money. Appreciate you providing all the additional detail. Thank you.

Sure. Thank you, Charles.

Thank you. At this time, I would like to turn the call back over to management for closing comments.

Thank you for joining us today. And I look forward to future calls. Have a great day.

Thank you. This concludes today’s teleconference. You may disconnect your lines at this time. And thank you for your participation and have a great day.