Catalyst Pharmaceuticals, Inc.

Hello, and welcome to the Catalyst Pharmaceuticals third quarter 2021 earnings call and webcast. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Ali Grandi, CFO. Please go ahead.

Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's Third Quarter, 2021 Financial Results and Corporate Highlights. Leading the call today, we have Patrick McEnany, Chairman and Chief Executive Officer. We are also 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'll 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 may be 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 risk, 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. Before-looking statements should be considered only in conjunction with the detailed information containing our SEC filings, including the risk factors described in our 2020 Annual Report No. Form 10-K. At this time, I'd like to turn the call over to Patrick.

Thanks, Allie. Good morning, everyone, and thank you for joining us today for Catalyst's third quarter results and update call. I'm very pleased to report that we delivered record FERDAPS revenue results for the third quarter ending September 30th. We generated net FERDAPS revenues of $35.9 million, an increase of 23% versus the third quarter of 2020. Burnout revenues for the nine-month period were $99.7 million as compared to $87.9 million for the nine months last year, which represents a 13% increase year over year. At this time, I anticipate continued organic growth through the end of this year and for the foreseeable future. Net income before income taxes for Q3 2021 was $14.1 million, a 20 percent increase when compared to $11.7 million for the third quarter of last year. We reported GAAP net income of $10.3 million for the third quarter of this year, or 10 cents per basic and diluted share. We entered the quarter with $174.8 million in cash and short-term investments, further supporting our long-term growth strategy to diversify through reinvestments in our business or external growth opportunities. These results also highlight the strength of our commercial capabilities and resilience as we continue to execute throughout the current environment. Allie will have more to provide during her financial presentation. Our share purchase program continues with 949,746 shares purchased in the open market during the third quarter. And since inception in March of this year, through the end of the third quarter, we have purchased 1,749,746 shares at an average price of $5.15 per share. Notwithstanding our success in treating many Lynch patients, As of now, we have only reached about 25% of the estimated 3,000 U.S. LEMS patients. We remain confident of the progress of our commercial team is making in evolving the market for the PERDAPS brand. We continue to make substantial investments in PERDAPS, focusing on expanding reach to targeted healthcare specialists, most recently to oncologists and general neurologists. providing resources to help shorten the diagnostic journey for LIMS patients, and support through patient and healthcare provider education programs. Our focus on commercial execution excellence remains a top priority to us, as well as to the patients we serve. Jeff will provide additional information on our commercial progress shortly. Importantly, we've made substantial advancements related to Ferdapp's exclusivity and commercial potential in the U.S. Most notable was the receipt of a positive decision from the 11th Circuit Court of Appeals supporting the orphan drug exclusivity for Ferdapp's tablets, 10 milligram, for treating limbs patients in the U.S. We are currently extremely pleased with the court's decision While there is a 45-day period for which an in-block hearing request can be submitted to the court related to the court's decision, we remain confident in our position and look forward to when we can fully recognize our exclusivity. Our priority has always been and will continue to be on addressing patients' needs first. We are well prepared to do everything we can to ensure that all LIMS patients will have uninterrupted access to amifapidine for treating their condition. We also continue to make important progress in bolstering our intellectual property for PRDAPs. Currently, two patents have been issued that extend the life of our intellectual property portfolio to 2034, both of which are listed in the Archbook. We have additional patents pending to further strengthen the IP portfolio, adding to our commitment to protect the innovation and the product's commercial potential. As we continue to execute our commercial-related initiatives, we are taking a very targeted approach towards our clinical development programs. We are working on expanding the label for FerdEvs as we plan to see U.S. approval to include pediatric limbs patients. which we believe numbers are 10 to 15 children. This program further underscores our continued commitment to providing an important treatment option for LIMS patients of all ages. We're also continuing our efforts to expand the global footprint for PROTEPs beyond the U.S., Canada, and Japan. Steve will have more to add shortly regarding activities outside the U.S. In addition, having objectively and thoroughly evaluated the clinical development timeline, regulatory path, and commercial viability for MuskMG, we have elected to end the program and concentrate our R&D efforts in other areas. We believe having a more focused approach towards our development programs will drive the greatest value for the company and enable us to better utilize our resources to pursue value-creating opportunities to expand our focus beyond FNFs. During the quarter, we made considerable progress in our efforts to build a more diversified portfolio that aligns our growth strategy and priorities, including the potential to expand the breadth and depth of our pipeline. With a robust process in place during the third quarter of 2021, we engage in extensive due diligence activities on a potential acquisition that fit our strategic objectives. However, after a thorough and extensive assessment of the acquisition candidate, we elected not to further pursue this opportunity. Coupled with our strong balance sheet, we are in an excellent position to take advantage of opportunities that meet our specified criteria and commitment to pursue rare disease opportunities and are very encouraged about projects that are currently under review. Our quarterly achievements demonstrate continued performance excellence, supported by several key strategic decisions that have positioned Catalyst firmly for the future. In saying that, we are excited about the path ahead as we continue to execute across all priorities to drive sustainable growth for the long term. Finally, there are a couple of other points worth noting. First, we achieved these results during a period when Catalyst and most of our peers were affected to some degree by the Delta variant of COVID-19. As this variant is abating, we are beginning to see a more normalized pattern of practices with healthcare providers and patients. Lastly, while addressing the COVID-19 effects, I want to reiterate that as we have previously stated, our supply chain is rock solid with qualified redundancies throughout our supply chain. Now I will turn the call over to Jeff DelCarmen, our Chief Commercial Officer, who will provide further highlights of our commercial execution for the quarter.