Catalyst Pharmaceuticals, Inc.

Greetings, and welcome to the Catalyst Pharmaceuticals second quarter 2022 earnings conference 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. Please note, this conference is being recorded. I'll now turn the conference over to your host, Ali Grandin. You may begin.

Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's second quarter 2022 financial results and corporate highlights. Leading the call today is Patrick McEnany, Chairman and Chief Executive Officer. We're also joined by Dr. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer, and Jeffrey Del Carmen, our Chief Commercial 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 law. 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 annual report on Form 10-K. At this time, I'll turn the call over to Pat.

Thanks, Allie. Good morning, everyone, and thank you for joining us today on our second quarter 2022 financial results and corporate update call. We are very pleased to report that we delivered exceptional financial performance again for the second quarter of 2022, having achieved an all-time high in total FERDAPS net revenue of $53 million, representing an increase of 57.7% compared to the same period last year. Net income before income taxes for Q2 of 2022 was $28.2 million, a 77.6% increase compared to $15.9 million for Q2 of 2021. We reported GAAP net income of $21.6 million for Q2 of 2022, or 21 cents per basic share and 20 cents per diluted share. We continue to bolster our cash position as we ended the second quarter of 2022 with $220.8 million in cash and investments and no funded debt. Our second quarter results reinforced the strength of our strategy, and we are maintaining our full year 2022 guidance of total revenues to be between $195 million to $205 million. And as of now, we are guiding to the upper end of that total revenue range. We continue to expect operating expenses of $65 to $70 million for the full year. Our success is directly attributable to the continued exemplary execution by all of our employees in every functional area. Their continued dedication to ensuring the patients come first and all of our daily activities at Catalyst leads to our successful execution and progress as individuals and as a company. Our confidence in our strong cash flow enabled us to opportunistically take advantage of the market conditions by repurchasing 600,000 shares of our common stock in the open market during the second quarter at an average price of $7.26 per share, or about $4.4 million. Since the start of our share repurchase program in March of 2021, we have repurchased approximately 3.2 million shares for an aggregate price of an average price of $5.92 per share or about $19 million in the aggregate. We'll continue to be disciplined in executing share repurchases when we feel it is prudent and beneficial to our shareholders. Allie will provide more financial details in her presentation. We are pleased to have resolved our issues with Jacobus Pharmaceuticals by reaching a mutually agreeable settlement to the patent litigation and the litigation challenging the resurgi approval. As part of the settlement agreement, we acquired certain intellectual property rights, including the U.S. and Mexico rights to resurgi, and its U.S. NDAs. We also received the license of use for their know-how related to the manufacturing of the product. We believe the data included in the agreement may be useful, in addition to our existing data, to assist in optimizing FERDEP's approved labeling. We are pleased to report that the transition of assets is underway and occurring efficiently. As of now, we plan to use the limited supply of Resurgy that we repurchased from Jacobus to supply those patients with neuromuscular conditions other than limbs who are without access to an approved drug and who are being treated with Resurgy at the time of the settlement under investigator-sponsored INDs. At the same time, we will continue to concentrate our focus and resources on addressing the full needs of the LIMS patient community. Having completed this transaction just several weeks ago, we are continuing to evaluate the complexities and the issues related to our path forward for Resurgy in the U.S. and Mexico. With that said, our supplemental new drug application to support the approved use of VERDAPs for pediatric LIMS patients has been accepted by the FDA for review. If approved, this would likely expand the use of FERDAPs for this age group later this year. While the U.S. limbs pediatric population is a minimal number of patients, this initiative is part of our commitment to ensure that all patients have access to FERDAPs for the treatment of limbs. During this quarter, we also made significant progress in our efforts to identify acquisition opportunities towards building a diversified patient-centered portfolio aligned with our overarching growth strategy. Our key priority on that strategy and business development front continues to remain broadening and diversifying our product portfolio through collaborative partnerships, acquisition of commercial stage assets, or acquisitions of companies with 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're actively engaged in advanced stages of due diligence and evaluating several opportunities to acquire products and or companies with commercial stage products. While no agreements have been entered into at this time, we believe we are on a path to accomplish this objective in the second half of this year. We look forward to providing updates on our progress as permissible. We've also made significant progress in building the foundation of our formal Environmental, Social, and Governance, or ESG, program. We recently published our inaugural set of industry-specific disclosures recommended by the Sustainability Accounting Standards Board, or SASB, which is now available on the Catalyst website. This initiative constitutes the first stage of our ESD journey, and we look forward to advancing our efforts on this front. In summary, our exceptional performance was driven by the achievement of several important milestones, resulting in the financial accomplishments for the quarter and increasingly strong cash position. We are optimistic about our future and believe we are well positioned to continue to execute our growth strategy to deliver long-term value for stakeholders. I'll now turn the call over to Jeff Del Carmen, our Chief Commercial Officer, who will provide further highlights on our commercial performance.