Catalyst Pharmaceuticals, Inc.

Hello, and welcome to the Catalyst Pharmaceuticals third quarter 2023 financial results conference call and webcast. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. You may be placed into question queue at any time by pressing star one on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Chief Financial Officer Ali Grande. Please go ahead, Ali.

Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's third quarter 2023 financial results and corporate highlights. Leading the call today is Patrick McEnany, Chairman and Chief Executive Officer. We are also joined on today's call 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 our remarks 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 risks, uncertainties, and assumptions that are difficult to predict and may prove not to be accurate. 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 2022 Annual Report on Form 10-K. At this time, I'll turn the call over to Pat.

Thanks, Sally. Good morning, and welcome, everyone, to our third quarter 2023 Financial Results Conference call. We are pleased to report another quarter marked by exceptional financial results and the completion of another significant acquisition further shaping the future of the company. First, I'd like to review key financial highlights from the third quarter of 2023. We achieved total product revenues of $102.6 million, representing a year-over-year increase of 79.5% driven by continued revenue growth for our FirdApps and FICOMPA franchises. We reported yet another new all-time high net revenue of FirdApps for $66.2 million, reflecting an increase of 15.8% year-over-year, and year-to-date through the third quarter, FirdApps revenues increased by 23.1%, over the same period last year. This strong performance underscores another quarter of outstanding organic growth for FredEPS. Our overall revenue performance was fortified by PICOMPA net product revenues of $36.4 million, establishing a favorable 5.3% third quarter increase compared to the second quarter of this year. underscoring an important contribution to our growing revenue base. This should serve as a testament to our exceptional execution across all business fronts and our ability to successfully integrate the acquisition of strategic products. As a result of our year-to-date progress, we are raising our 2023 total revenue guidance to between $390 million and $395 million, from our previous guidance of $380 to $390 million. Non-GAAP net income for the third quarter was $55.9 million, or 49 cents per share diluted. This excludes from GAAP net income, non-cash, stock-based compensation, depreciation, a non-recurring one-time in-process R&D expense of $81.5 million associated with the acquisition of the North American license for a GAMRI, better known, also chemically known as Remora Loan, and the amortization of intangible assets. GAAP net loss was $30.8 million, or 29 cents per diluted share, which again includes the non-recurring one-time expense of $81.5 million associated with the acquisition of the Egamery license. While these previously disclosed non-recurring in-process R&D expenses impacted on our overall GAAP earnings per share, our performance underscores our fiscal discipline and operational execution. We ended the quarter with cash or cash equivalents of $121 million and continue to have no funded debt on our balance sheet. Allie will provide you with more financial details during her presentation. Our recent acquisitions reinforce our confidence that we are on the right path towards realizing our near and longer term strategic and financial goals. Early in the third quarter, we acquired from Santera Pharmaceuticals the license for the North American rights tube from Oralone, again, brand name Agamri, which was pending an FDA approval for the treatment of Duchenne muscular dystrophy, or DMD. On October 26th of this year, we announced the FDA approval of Agamri, oral solution, a novel corticosteroid for the treatment of DMD. We believe that Agamri may offer the potential to increase the duration of ambulation and mobility in these patients, thereby significantly improving their overall quality of life, also providing a more favorable side effect profile compared to other traditional steroid treatments. Steve will have more to say about the Agamri approval and the potential benefits to DMD patients during his presentation. As most of you know, the current standard of care treatment for DMD involves corticosteroids, which often come with significant side effects. It is estimated that between 11,000 and 13,000 children in the U.S. are affected by DMD, with approximately 70% of the patients currently receiving corticosteroid treatment. We strongly believe that a gamma-rate has the transformational potential to reshape the treatment period for this debilitating rare disease and holds the prospect for future possibilities for other chronic inflammatory conditions. Agamri has orphan drug and rare pediatric disease designations status for DMD, qualifying it for seven years of U.S. market exclusivity, as well as a number of issued and pending patents that extend to 2040. Per our licensing agreement with Santera, the approval of the GAMRI triggers a $36 million milestone payment that, when paid this fourth quarter of this year, will be recorded as an intangible asset and amortized over its useful life of 10.5 years. We are excited about the commercial launch of the GAMRI. a highly synergistic product to our existing neuromuscular franchise, which is planned to occur in the first quarter of 2024. At that time, we will introduce our comprehensive financial assistance program aimed at helping to ensure access and affordability for all DMD patients through our white glove Catalyst Pathways platform. Jeff will address some of the questions that many of you are asking about the opportunity that Agamri represents for Catalyst. You will note in the fourth quarter, we anticipate incurring an additional $6 to $7 million in commercial and other expenses related to the Agamri launch preparations. In the third quarter, We announced that the SNDA seeking to increase the daily maximum dose of Ferdaps to 100 milligrams had been accepted for filing. We have been provided a PDUFA action date of June 4, 2024. This represents a meaningful milestone as we estimate that about 40% of patients currently on treatment are already at or approaching the current maximum daily dose of 80 milligrams. We also just recently announced the allowance of two new patents to further strengthen the Ferdapps intellectual property estate, which currently has patent protection until 2037. Plans are underway to list these patents in the FDA's Orange Book as soon as they are issued, bringing the total number of listed patents of Ferdapps to eight. With the second consecutive full quarter of FICOMPA under our belt, We are pleased with its positive growth trend. We attribute this success to our dedicated epilepsy franchise teams, who are actively engaged with healthcare providers in the efficacy communities. We expect a continued tailwind for Phi Kappa due to its unique status as the only non-competitive AMPA receptor antagonist, and that epilepsy patients tend to stay with the current treatment regimen once they achieve seizure-free status. As we enter the fourth quarter, we expect an NDA submission for FredApps to the PMDA in Japan by our partner, Dido Pharma, before the end of this year, which will trigger a $2 million regulatory milestone payment by Dido to Catalyst. Acceptance of the submission in Japan also triggers an expansion of our territorial rights for FRDAPs under our amended license agreement with CERB. We are developing plans to pursue opportunities to expand our global footprint through strategic partnerships with our current focus on the Asia Pacific and LATAM regions. Looking at the business development side of the company, where we are focused on pursuing adequately de-risked and value-added transaction opportunities. We continue to demonstrate progress with the recent closing of the acquisition of the North American rights to a GAMRI from Santera. We've advanced our portfolio expansion strategy search and evaluation efforts around two key pillars. focusing on broadening and diversifying our rare neuromuscular and epilepsy product portfolios with sufficiently de-risked innovative therapies that address critical unmet medical needs. And second, expanding the geographic footprint of our existing products. Overall during this quarter, we've gained significant ground in our portfolio expansion efforts. We are currently in the advanced stages of due diligence on additional commercial stage opportunities that could come to fruition over the next few quarters. After a robust and comprehensive search, I was very pleased to announce that Rich Daley was our candidate of choice as my successor as CEO. As reported, Rich has over three decades of biopharma experience with large multinationals as well as smaller, more entrepreneurial companies. Rich's background and core strength is on the commercial side of the business, an attribute that is key to our near-term and mid-term strategic plan. He has been on our board of directors for almost nine years and has been an integral part of the team that has helped design our current strategic plan and focus. Rich and I have been working together closely since the announcement to ensure a smooth transition come January 1st of next year. Looking ahead to next year, we are fully prepared for sustained progress fueled by our ability to execute, paving the path for further growth. With the collective capabilities of our Catalyst team, there is no doubt that we will continue to achieve noteworthy accomplishments and making a lasting impact on the lives of the patients that we serve. I'll now turn the call over to Jeff DelCarmen, our Chief Commercial Officer, who will update us on our commercial activities.