Catalyst Pharmaceuticals, Inc.

Ladies and gentlemen, and welcome to the Catalyst Pharmaceutical Incorporated Third Quarter 2022 Financial Results Conference Call. All lines have been placed on the listen-only mode, and the floor will be open for questions and comments following the presentation. If you should require assistance throughout the conference, please press star zero on your telephone keypad to reach a live operator. At this time, it is my pleasure to turn the floor over to your host, Ali Grande, Chief Financial Officer. Ma'am, the floor is yours.

Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's Third 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. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer, and Jeffrey Del Carmen, our Chief Commercial Officer. Further, for the Q&A session, we will also have Dr. Gary Ingenito, our 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 risks, uncertainties, and assumptions that are difficult to predict and may prove not to be accurate, especially in light of the continued effects of COVID-19. Actual results may vary from the expectations contained in our forward-looking statements. The 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 and will report on Form 10-K. At this time, I will turn over the call to Pat.

Thanks, Allie. Good morning, everyone, and thank you for joining us today on our third quarter 2022 financial results and corporate update call. We are incredibly proud to report our outstanding third quarter financial results, which marks another consecutive quarter of FERDAP's revenue growth in an all-time high recorded quarterly net product revenue of $57.2 million, representing a 59.3% increase over the third quarter of 2021. We reported GAAP net income of $22.7 million for the third quarter of 2022, or 22 cents per basic share and 20 cents per share per diluted share, which also reflects a $4.6 million charge in the third quarter related to the accounting treatment for the write-down of the Resurgy inventory and the amortization expense related to the acquisition of certain assets from Jacobus Pharmaceutical Company. Our non-GAAP net income for the third quarter was $28.6 million, or 28 cents per basic share and 26 cents per diluted share. Non-GAAP net income removes from our GAAP net income our non-cash stock-based compensation and depreciation and amortization and our income tax provision. Allie will have much more to say about the accounting treatment and the impact on our P&L as a result of the acquisition of certain Jacobus assets during her presentation. We enter the fourth quarter. with further confidence that we are on the right path to achieving our 2022 objectives and goals. In the month of October, we matched our best month for new enrollments in Catalyst Pathways, and as a result, we are revising upward our full-year 2022 FERDEP's revenue guidance to $205 to $210 million. Our 2022 financial guidance for cash OPTX of $65 to $70 million remains intact and will exclude the impact of any strategic acquisitions. Our cash position continues to grow as we enter the third quarter of 2022 with $256 million in cash and short-term investments. This is a $35.3 million increase in 2022 third quarter over the prior quarter amount and represents the largest quarterly increase in cash and short-term investments to date, which further demonstrates our continued fiscal discipline. Please keep in mind that this is after paying the $10 million initial payment to Jacobus for acquiring the rights to certain of their assets early in the third quarter. Also, our share repurchase program is currently on hold. as we are conserving cash for expected business development activities. As you know, approximately 50% of patients with limbs suffer with a comorbidity of small cell lung cancer. We've commenced a soft rollout of our new marketing initiative to reach and teach thoracic oncologists and others in the physician community to treat small cell lung cancer about limbs. These programs represent a large untapped opportunity for us to help oncologists identify limbs early and thus get their patients on drugs sooner for hopefully a better quality of life. Our new oncologist targeted programs will hit the ground full speed at the beginning of next year. Jeff will have more to say about these programs in a few minutes. Early in the third quarter, we achieved a global settlement of all U.S. litigation involving Jacobus Pharmaceuticals as part of the acquisition of certain Jacobus assets. With the acquisition of the Resurgy assets completed, our team is actively assessing the path forward for the product. In the meantime, we continue to provide the existing Resurgy inventory to patients receiving treatment for neuromuscular conditions other than limbs who were previously receiving the drug under existing investigator-sponsored INDs. The long-term prospects for Resurgy are being evaluated, which involve many complex issues related to manufacturing, regulatory, cost, and financial feasibility. As part of the acquisition, we added two more patents to our intellectual property portfolio. With an additional patent listed in the orange book, with an expiration date of February 2037, bringing the total number of U.S. patents listed in the orange book to six. We also announced the receipt in the third quarter of the U.S. approval of the supplemental new drug application for PRDAPs, expanding the indicated age range to include pediatric patients six years of age and older for the treatment of limbs. While this patient population is estimated to be less than 30 pediatric patients in the U.S., this milestone demonstrates our continued commitment to the LIMS patient community that we serve. During the third quarter, we made significant strides in our efforts to identify acquisition opportunities towards building a diversified patient-centric portfolio aligned with our overarching growth strategy. Our key priority on the strategy and business development front continues to remain our intention to broaden and diversify our product portfolio through collaborative partnerships, acquisition of commercial stage assets or companies. Currently, we are in advanced stages of due diligence to acquire commercial stage products and or companies. And while no agreements have been reached to date, We are hopeful that we will be in a position to announce a transaction later this year. We recently advanced our Environmental, Social, and Governance, or ESG, initiatives with the launch of the comprehensive assessment of key ESG topics to identify appreciable targets for our sustainability activities. These efforts will serve as the foundation for our initial sustainability report, which we anticipate will be published in the first half of 2023. Just this week, we announced the catalyst was named Company of the Year by Bio Florida. This recognition was for the achievement of significant milestones and to the growth of Florida's life science industry. We are honored to have been recognized for our many accomplishments, which is a testament to the entire Catalyst team for their dedication and hard work. In addition, we were recently ranked number 39 in Fortune Magazine's 2022 top 100 fastest-growing companies. This ranking is based on the company's growth in revenues, profits, and stock returns over the three-year period through June 30th of 2022. for which we achieved 176% growth during that period. On September 15th, we were added to the S&P Small Cap 600 Index. The S&P Small Cap 600 Index is a stock market index established by Standard & Poor's. It covers roughly the small cap range of U.S. listed stocks. using a capitalization weighted index. To be included in the index, a stock must have a total market cap that ranges from $850 million to $3.7 billion. As we entered the fourth quarter with sustained momentum, we are well positioned to continue to execute our strategic priorities to strengthen the business with opportunities that translate into added long-term value and growth for our stakeholders. We are excited by the direction in which we are headed and expect to close out the year on a high note. I'd like to thank all of our valued Catalyst team members, as well as the LHINs patients and physician community that we serve. I'll now turn the call over to Jeff Del Carmen, our Chief Commercial Officer, who will further highlight our commercial performance.