Catalyst Pharmaceuticals, Inc.

Greetings and welcome to Catalyst Pharmaceutical CPRx First Quarter, our 2022 Financial Results Conference Call. At this time, all participants are in listening mode. A brief question and answer session will follow the formal presentation. If anyone should require assistance during the conference, you're welcome to press star then zero on your telephone keypad. As a reminder, This conference is being recorded. It is now our pleasure to introduce your host, Ali Grande, CFO of Catalyst Pharmaceuticals. Please go ahead, ma'am.

Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's first quarter 2022 financial results and corporate highlights. Leading the call today is Patrick McEnany, Chairman and Chief Executive Officer. We are also joined by Dr. Steven Miller, our Chief Operating Officer and Chief Scientific Officer, and Jeffrey Del Carmen, our Chief Commercial Officer. Further, for the Q&A session, we'll have Dr. Gary Ingenito, our Chief Medical and Regulatory Officer, and Brian Elsburn, our Chief Legal and Compliance Officer. Before we begin, I would like to remind you that in our presentations this morning 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 on Form 10-K. At this time, I'll turn the call over to Pat.

Thanks, Sally. Good morning, everyone, and thank you for joining us today for Catalyst's first quarter 2022 financial results and update call. As you can see, we had a remarkable first quarter as we delivered record net product revenue of $43 million, a 42.5% increase compared to Q1 of 2021, and ended the quarter with $198 million in cash and short-term investments. Net income before income taxes for Q1 of 2022 was $17.5 million, a 76.7% increase compared to 9.9 million for Q1 of 2021. We reported GAAP net income of $13.2 million for Q1 of 2022, or 13 cents per basic share and 12 cents per diluted share. During Q1 of this year, we repurchased 400,000 shares of our common stock from the open market. at an average price of $6.38. Since we started the program in March of last year, we have repurchased a total of 2.6 million shares at an average price of $5.61. We continue to make purchases at times when we feel it is prudent and beneficial to our shareholders. As a result of the outstanding performance for the quarter, we are reiterating our full year 2022 total revenue guidance of $195 million to $205 million, representing a 38% to 45% increase in total revenues compared to 2021. We also anticipate our cash OPEX, that is research and development and SG&A expenses, to be between $65 and $70 million for the full year. I'd like to begin today's discussion with a brief overview of our commercial performance and execution for the quarter. Our robust growth was attributed in part to the positive outcome from the 11th Circuit decision reaffirming our orphan drug exclusivity for FERDAPs for the treatment of Lambert-Eaton myasthenic syndrome, or LEMS. The removal of Resurgy from the market in February of this year, following our favorable court ruling, was a defining inflection point for additional new patient enrollment growth, as those patients previously prescribed Resurgy sought to transition to herd apps. We anticipate the number of those patients to be about 125, almost all of which are adult LIMS patients. As of the end of April, most all of those patients have transitioned to Ferdaps from their prior treatment. We anticipate the conversion of the remaining patients to be completed by the end of this quarter. We believe the success rate is attributed to the exceptional competencies of our patient assistance teams and programs that were ready and prepared to help ensure these patients with a seamless transition. We also continue to achieve high organic new patient growth for FERDAPs, attributed to the successful execution of our commercial plan. We benefited from the several key initiatives that have been underway, including enhanced awareness and education of patients, caregivers, healthcare professionals, and expanded focus on perineoplastic patients, lens patients, and thoracic oncologists, that treat those pyreneoplastic patients, and access to a diagnostic test to help accelerate the process for definitive diagnosis. We're extremely pleased with the performance of our commercial organization. As we enter the second quarter with continued momentum, we expect to sustain the organic growth rate driven by newly diagnosed patients and the considerable number of patients diagnosed with limbs who are not yet on Ferdapse. We estimate that there are approximately 3,000 LIMS patients in the US, of which, based on insurance claims data, half are without a diagnosis or are misdiagnosed. Of the approximately 1,500 patients that have received a definitive diagnosis for LIMS, we've only reached slightly over 800 patients, leaving much work to be done to assist the remaining patients to a definitive diagnosis and to find their way to an FDA-approved therapy to treat their LIMS condition. We've also fortified our intellectual property estate with the issuance of three new patents, which are now listed in the Orange Book. These patents are directed to the treatment of patients suffering from LIMS and covering all amifampranine metabolizer types within the LIMS patient population. We believe that these new patents will enhance the commercial durability of FirdEPS, which has US patent protection until 2034. During the quarter, we've made considerable progress in our effort to build a more diversified portfolio that aligns with our growth strategy and revised acquisition criteria. Our key priority on the strategy and business development front remains to broaden and diversify our product portfolio through collaborative partnerships, acquisition of commercial stage assets, or companies with FDA-approved rare disease therapies. To accomplish these objectives, our chief strategy officer, Dr. Preeti Sundaram, is tasked with spearheading a stringent and disciplined approach to evaluating assets for portfolio expansion. At this time, we are actively engaged in evaluating several potential opportunities to acquire products and or companies with drug products in commercial stage. However, no agreements have been entered into to date. On April 8, 2022, Jacobus Pharmaceutical filed a petition of writ of cert with the U.S. Supreme Court to appeal Catalyst's favorable decision from the 11th Circuit Court of Appeals. Now that the petition is filed, they are waiting for a decision as to whether the High Court will grant the request for cert. With only about 1% of all such petitions typically granted by the court for review, we have been prepared for the prospect of this filing. This appeal process could take several months, during which time resurgi status remains not approved in the US. We have submitted and SNDA for pediatric label expansion to the FDA is part of our commitment to provide the very few pediatric LEMS patients with access to an approved therapy. In the meantime, we continue to make FirdEPS available to any pediatric LEMS patients through our expanded access program at no cost. In March of 2022, We also received a favorable Canadian federal court ruling enforcing Ferdep's innovative drug data protection. This resulted in the setting aside of the approval of Resurgy, and it has been removed from the market in Canada. The matter has been remanded to the Minister of Health for redetermination. Our other litigation is the patent infringement case against Jacobus and Panther Rx. the specialty pharmacy for Resurgy. This suit is in the early stages of discovery. We'll continue to keep you advised as this case progresses. On Global Rare Disease Day at the end of February, we are proud to partner with several national patient organizations to increase awareness about rare diseases, focusing on important health messages about limbs diagnosis, treatment, and quality of life issues. The goal included raising awareness of rare diseases and helping amplify the voices of those patients in need of innovative new therapies. I'll now turn the call over to Jeff DelCarmen, our Chief Commercial Officer, who will provide you further highlights on our commercial execution.