Catalyst Pharmaceuticals, Inc.

Greetings and welcome to the Catalyst Pharmaceuticals fourth quarter and full year 2021 results call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Allie Grandy, Chief Financial Officer for Catalyst Pharmaceuticals. Thank you. You may begin.

Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's first quarter and full year 2021 financial results and corporate highlights. In the call today, we have Patrick McEnany, Chairman and Chief Executive Officer. We are also joined by Dr. Stephen 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 from the expectations contained in our forward-looking statements. 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 2021 annual report in Form 10-2. At this time, I'll turn the call over to Beth.

Thanks, Allie. Good morning, everyone, and thank you for joining us today for Catalyst's fourth quarter and full year 2021 financial results and update call. 2021 was an extraordinary year for Catalyst as we attained several significant milestones and achieved strong financial performance, creating a substantial foundation to sustain our growth plans as we diligently pursue opportunities to diversify our commercial and development portfolio. To date, in 2022, we have continued to execute our business plan and operate the budget. Let's start with our commercial performance in the fourth quarter of 2021, where we achieved FERDAP's net product revenues of $38 million a 24% revenue increase versus the fourth quarter of 2020. Growth during the fourth quarter was driven by continued strong FERDAPS performance, despite not yet being back to optimal pre-pandemic conditions. Our full year 2021 total revenues were $141 million, representing an 18% increase year-over-year compared to $119 million in total revenue for 2020. Net income before income taxes for Q4 of 2021 was $12.8 million, a 47% increase compared to $8.7 million for Q4 of 2020. We reported GAAP net income of $9 million for Q4 of 2021, or 9 cents per basic and diluted share. We ended the year 2021 with $191 million in cash and short-term investments. We continue to judiciously repurchase shares of our common stock from the open market. During 2021, we repurchased 2.2 million shares at an average price of $5.47 per share for a total purchase price of $12.1 million. We have guided full-year 2022 total revenues to be between $195 million and $205 million, representing a 38% to 45% increase in total revenues compared to 2021. We also anticipate our cash op-ex to be between $65 and $70 million for the full year. Allie will provide you with more details during her financial report. Our 2022 guidance assumptions reflect the positive outcome from the U.S. courts reaffirming the orphan drug exclusivity for FERDAPs for the treatment of adult patients with Lambert-Eaton myasthenic syndrome. As we reported last month, the U.S. District Court ruled that the U.S. approval of Resurgy for the treatment of pediatric women's patients violated the U.S. orphan drug exclusivity for FERDAPs. As a result, the U.S. approval previously granted for Resurgy for pediatric patients has now been rescinded by the FDA. The reaffirmation of FERDAPS market exclusivity is a significant milestone, enabling us to advance treatment within the LIMS community, where FERDAPS has already been prescribed by 647 unique physicians to approximately 25% of the estimated 3,000 LIMS patients. Importantly, this outcome represents a pivotal point for additional new patient enrollment growth, as those patients on Resurgy seek to transition to Ferdaps. We estimate the number of patients recently on Resurgy to be about 125 patients, a significant majority of whom are adult LIMS patients, and we've already seen many of those patients transition to Ferdaps during this quarter. which aligns with our revenue forecast for the year. The transition of Resurgy patients to PRDAPs is proceeding seamlessly, thanks to our patient-first approach and our established Catalyst Pathways Access Programs, which are there to assist all patients seeking access to PRDAPs for limbs treatment. Similarly, we announced last week a victory in the Federal Court of Canada in the lawsuit by Catalyst and Kai Pharmaceuticals to require Health Canada to enforce the data protection for Ferdaps as an innovative drug. In that case, the judge agreed with our positions on the applicability of the data protection provisions and that Health Canada's approval of Resurgy did not comply with them. Resurgy has been removed from the market in Canada and the matter remanded to the Minister of Health for redetermination consistent with the judge's decision. Our other significant litigation is our pending patent suit against Jacobus and Panther Rx, Jacobus' specialty pharmacy for resurging. This suit is now in discovery and we'll continue to keep you advised as this case progresses. We entered 2022 with significant momentum and with a continued focus on sustained product growth as well as to the rare disease community we serve. We have enhanced our efforts to drive awareness and education to both patients and providers with an expanded focus on perineoplastic patients. Extending out to thoracic oncologists provides an important potential for reaching new lens patients as approximately 50% of lens patients have some form of cancer, most typically small cell lung cancer. We also expect to see continued growth with newly diagnosed LIMS patients who are not yet on PRDAPs, as well as acceleration of the process for definitive LIMS diagnosis. We have also made important advances in strengthening our intellectual property portfolio for PRDAPs. With the recent issuance of three new U.S. patents, These patents are directed to the treatment of patients suffering from LIMS and cover all amifampradine metabolizer types within the LIMS patient population. This milestone further fortifies our intellectual property of state, and we believe this provides us with lasting commercial durability for PRDAPs, which has U.S. patent protection until 2034. All of these newly issued patents will be listed in the FDA's Orange Book within the next few weeks, which will bring the total number of patents listed to five. We will continue to execute our key initiatives to further strengthen and protect the long-term durability of FERDEPs. Steve will provide more details later in this call. We're also pleased with the progress being made by our sub-licensing partner, Dido Pharma. In December 2021, GAIDO initiated a small phase three registration study in Japan to evaluate the efficacy and safety of FURDAPs for the treatment of limbs. The initiation of this trial marked an important milestone towards expanding our global footprint. Currently, there are no approved treatments for limbs in Japan, and we believe FURDAPs can provide a meaningful new therapy option to those living with this disease. Assuming the trial is successful, we expect VIRDAPs to be granted 10 years of market exclusivity upon approval in that market. Our goal to expand our portfolio and pipeline with differentiated products to treat rare diseases, which currently are without any approved therapy, remains a strategic priority for this year. We have a robust and enhanced process in place and identifying potential assets to pursue and have made considerable progress on this front. Our teams are actively engaged in extensive due diligence and we are encouraged about projects currently under review. We remain confident in our ability to advance on these initiatives this year. As part of our ongoing effort to help raise awareness and amplify the voices of patients with rare disease in need of approved therapies, we recently teamed up with the leading patient advocacy groups and our partners at NASDAQ for participating in the opening golf ceremony on February 28th to honor Global Rare Disease Day 2022. We thank all of our partners for coming together and allowing us to show our support the rare disease community as a result of the many accomplishments catalyst is named on forbes 2022 america's best small companies published list ranking 65 out of more than 1 000 companies screened it is an honor to be recognized by forbes as one of the country's best small companies as well as the acknowledgement of the value we are creating In saying that, we are excited about the path ahead of us. We continue to execute across all near and long-term priorities to drive substantial growth. We believe that we are well-positioned to build upon our success. We are optimistic about the future. Now I will turn the call over to Jeff DelCarmon, Chief Commercial Officer of who will provide further highlights on our commercial execution.