Greetings and welcome to the Catalyst Pharmaceuticals Fourth Quarter and Full Year 2022 Financial Results Conference Call. At this time all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce one of your hosts, Ali Grande, Chief Financial Officer. Please go ahead.

Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's fourth quarter and full year 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 Jeffry Del Carmen, our Chief Commercial Officer. 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 our 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 and Form 10-Q. At this time, I will turn the floor over to Pat.

Thanks, Ali, and welcome everyone to our fourth quarter and full year 2022 results conference call. I'm pleased today to highlight the progress we've made across our business throughout 2022 and now into the start of 2023. As we did in yesterday's press release, let me highlight several key points. 2022 was a pivotal year for Catalyst as we delivered exceptional financial performance exceeding our 2022 total net revenue guidance projections driven by consecutive quarterly revenue growth and fiscal discipline. The robust results capped an important year of transformation as we successfully executed our strategic initiatives across all segments of the business. This included attaining a favorable resolution of the capital litigation relating to the RUZURGI, along with the U.S. rights, underscoring the strength of the FIRDAPSE intellectual property portfolio. The receipt of a positive U.S. court decision supporting FIRDAPSE orphan drug exclusivity, the approval of an expanded pediatric indication for FIRDAPSE, and the recent acquisition of FYCOMPA. With our sights set on further expansion, these accomplishments added considerable strength to our neuroscience presence and confidence that we can accelerate the company's long-term growth strategy. It's important to note, FIRDAPSE continues its strong performance and remains the cornerstone of our success. We are pleased with the strong demand and growth for FIRDAPSE, as we continue to see very positive trends across several of our key performance indicators, which Jeff will address shortly. Our full year 2022 total revenues were $214 million, representing a 52% year-over-year increase compared to $141 million in total revenue for 2021. Fourth quarter total net revenues were $61 million, a 59% increase compared to $38 million in 2021. We reported GAAP net income of $83 million for the full year of 2022 or $0.80 per basic share and $0.75 per diluted share, a 110% increase compared to $39 million or $0.38 per share basic and $0.37 per share diluted in 2021. Further non-GAAP net income for the full year 2022 was $114 million or $1.10 per basic and $1.02 per diluted share, a 93% increase compared to $59 million.

Ladies and gentlemen, please hold while we reconnect our speakers.

Okay. Our full year 2022 total net revenues were $214 million, representing a 52% year-over-year increase compared to $141 million in total net revenue for 2021. Fourth quarter total net revenues were $61 million, a 59% increase compared to $38 million in 2021. We reported GAAP net income of $83 million for the full year of 2022 or $0.80 per basic share and $0.75 per diluted share, a 110% increase compared to $39 million or $0.38 per basic share and $0.37 per diluted share in 2021. Further, non-GAAP net income for the full year 2022 was $114 million or $1.10 per basic share and $1.02 per diluted share, a 93% increase compared to $59 million or $0.57 per basic share and $0.55 per diluted share for the full year 2021. Additionally, we ended 2022 with $298 million in cash and cash equivalents. With another year of expected growth in front of us, we have recently provided the market with our forecast of full year 2023 total net revenues of between $375 million and $385 million, representing a 75% to 80% increase in total net revenue compared to 2022. We have also forecasted FIRDAPSE’s 2023 net revenues to be between $245 million and $255 million. Based on 11 months of sales projections, we expect FYCOMPA 2023 net revenues to be approximately $130 million. We are extremely pleased to have delivered on this important objective for 2022. We continue to expect that FYCOMPA will be accretive to our EBITDA and EPS for this year. Ali will provide further financial highlights and details during her remarks. During the current quarter, our focused and diligent process to pursue value-added transaction opportunities has come to fruition with the successful acquisition of the U.S. rights to FYCOMPA from Eisai Company Limited. FYCOMPA not only broadens our commercial product portfolio with the first and only noncompetitive AMPA receptor antagonist for epilepsy but also adds a growing revenue base, further augmenting our already strong revenue and earnings growth of FIRDAPSE. More importantly, the addition of FYCOMPA serves as a complementary growth driver and a strategic market adjacency within neuroscience that establishes a potential gateway to expand into rare epileptic diseases. We are already working closely and collaboratively with the Eisai FYCOMPA U.S. leadership and expect to complete the full transition of FYCOMPA activities by midyear 2023, and we look forward to the future onboarding into the Catalyst family many of the Eisai employees who have been responsible for the success of the FYCOMPA epilepsy program to date. During this quarter, although we did not enter into any new contracts to acquire additional products, we continue to make significant strides in our efforts to identify acquisition opportunities that align with our overarching growth strategy to build a diversified patient-centric portfolio. Our key priority on the strategy and business development front remains our intention to broaden and diversify our product portfolio through collaborative partnerships and acquisitions of commercial stage assets and/or companies. Currently, we are in advanced stages of due diligence on several commercial stage products and/or companies and strongly believe that a transformational expansion of our portfolio that offers the potential to further implement our near- and long-term growth strategy could occur in 2023. We remain optimistic about FIRDAPSE's long-term growth prospects. During 2022, we made significant advancements related to FIRDAPSE's intellectual property estate, which included the affirmation of the token drug market exclusivity. Additionally, we were granted three new patents and ended the year with six FDA Orange Book-listed patents that will remain valid until 2037, which we believe supports the product's long-term durability. We remain confident about the strength of FIRDAPSE's intellectual property estate, supported by the successful outcomes achieved in 2022. That said, we are limited in what we can say at this point about ongoing litigation other than to say that we intend to vigorously defend and prosecute any infringers of our intellectual property related to FIRDAPSE.

Thanks, Pat, and good morning, everyone. 2022 was a very successful year for Catalyst as well as the LEMS community. First, we are very proud to announce that over 1,000 unique patients have now received the FIRDAPSE enrollment from launch to date, which is a tremendous milestone for LEMS patients in the United States. We are very pleased with the full year FIRDAPSE net sales of $214 million, representing a 52% increase year-over-year, driven by consecutive quarterly FIRDAPSE net product sales growth. In Q4, net FIRDAPSE sales were $61 million, a 6% growth quarter-over-quarter. These achievements demonstrate the strength of our commercial strategy and capabilities, giving confidence for continued organic growth. The foundation of the FIRDAPSE business is solid. Operational excellence drove new patient starts, maintained favorable prescription approval rates of greater than 90% across all payers, government or private commercial insurers; continued high compliance of 90%; and lower discontinuations. Naive new enrollments in 2022, not including LEMS patients that transitioned from RUZURGI to FIRDAPSE were 25% greater year-over-year, while the annual discontinuation rate was 15%. The Q4 discontinuation rate was only 2.8%. Patients enrolled in Catalyst Pathways, including those who are covered by Medicare, in accessing foundation assistance have an average co-pay of less than $2 per month. As Pat mentioned, we have forecast FIRDAPSE's net revenues of $245 million to $255 million. In 2023 we are confident that our strategic growth initiatives will drive organic growth moving forward.

Thanks, Jeff. Our clinical development and regulatory strategy for FIRDAPSE continues to focus on expanding access to all LEMS patients, enhancing the FIRDAPSE patent estate to maximize its commercial potential, and to integrate the newly acquired FYCOMPA product into Catalyst's systems. First, I would like to discuss our development efforts to increase the indicated maximum dose of FIRDAPSE from 80 milligrams per day to 100 milligrams per day. We anticipate meeting with the FDA to outline our strategy in the second quarter, and assuming a positive outcome of that meeting, we plan to file a supplemental NDA in the third quarter of this year, seeking to increase the indicated maximum daily dosage of FIRDAPSE to 100 milligrams per day. A number of LEMS patients are already being treated at a 100 milligrams daily dosage of FIRDAPSE after their physicians worked with the pharmacy and insurance providers to justify the higher dose. Other patients on the current indicated maximum dose of 80 milligrams per day and their physicians have expressed a need to increase the indicated daily dosage to 100 milligrams to optimize therapy. This planned supplement, if approved, will help those patients. The previously acquired RUZURGI rights gave us access to safety and efficacy data for those patients treated at the 100 milligram daily dose, and that data has been incorporated into our strategy, along with our own data, including safety data for patients treated at a 100 milligram daily dose of FIRDAPSE. We believe that the combined data set provides an acceptable basis for seeking a 100 milligram maximum indicated daily dosage for FIRDAPSE. The investment community will be regularly updated on this project as it progresses. I would next like to comment on our previously approved supplemental new drug application for FIRDAPSE to treat pediatric LEMS patients. During the first quarter of 2022, we filed this supplemental NDA and it was approved by the FDA on September 29, 2022. With the approval of this supplemental NDA, all pediatric patients aged six and above and all adults now have access to FIRDAPSE as an FDA-approved product for LEMS in the United States. The pediatric LEMS patient population is a very small patient group, with an estimated size of less than 30 patients in the United States. This supplement highlights our commitment to ensure that all LEMS patients have access to FIRDAPSE. Regarding our global expansion, our sublicense partner, DyDo Pharma in Japan, has completed the enrollment in their FIRDAPSE Phase III clinical trial, which is required to seek approval for the Japanese market. The safety follow-up phase of that study to collect safety data in a Japanese patient population is ongoing. We continue to anticipate completion of that trial by the end of the year and assuming the trial is successful, a Japanese NDA submission in 2024. It is estimated that there are about 1,200 to 1,300 LEMS patients in Japan.

Thanks, Steve. We are very pleased with our financial results for the fourth quarter and full year 2022 and remain steady in our performance. We reported GAAP net income for 2022 of $83.1 million, or $0.80 per basic and $0.75 per diluted share, a 110% increase year-over-year, compared to a GAAP net income of $39.5 million or $0.38 per diluted share. Total net revenue for 2022, principally from FIRDAPSE's first revenue net, was $214.2 million, a 52% increase year-over-year when compared to total net revenue of $140.8 million for 2021. For the year 2022, our effective tax rate was 21% compared to 25% for the year 2021. The decrease in the effective tax rate for 2022 is due to an increase in stock option exercises during the year due to an increase in our stock price. We expect that our FX will fluctuate in future periods and remain higher in future periods than was for the year 2022. Non-GAAP net income for 2022 was $113.1 million or $1.10 per basic and $1.02 per diluted share, which excludes GAAP net income of $83.1 million, stock-based compensation expense of $7.9 million, depreciation of $141,000, amortization of $1.1 million, and an income tax provision of $21.6 million. This compares to non-GAAP net income for 2021 of $58.9 million or $0.57 per basic and $0.55 per diluted share, which excludes from GAAP net income of $39.5 million, stock-based compensation expense of $6.1 million, depreciation of $192,000 and an income tax provision of $13.2 million. The above represents an approximately 93% year-over-year increase of non-GAAP net income. Cost of sales of $34.4 million for 2022 increased when compared to $21.9 million for 2021. For both years, 2022 and 2021, cost of sales was approximately 16% of product revenue net and consisted principally of royalties due to our FIRDAPSE licenses. Research and development expenses were $19.8 million in 2022 compared to $16.9 million in 2021, an increase of $2.9 million in R&D was principally related to the acquisition of $4.1 million of RUZURGI inventory, fully recorded to expense in the third quarter of 2022, offset by an overall decrease in R&D expense. R&D expenses decreased as a percentage of total operating expenses to 18% for 2022 from 19% for 2021. SG&A expenses for 2022 totaled $58.2 million compared to $49.6 million for 2021. The increase of $8.6 million compared to the prior year is due to, among other changes, increases in compensation and benefit expenses as we continue to grow our business, additional charitable contributions to support LEMS patients, and amortization of intangibles acquired in connection with the RUZURGI acquisition in July of 2022. As a percentage of total operating expenses, SG&A expenses decreased to 52% for 2022 compared to 56% for 2021. As reported, we ended 2022 with cash and equivalents of $298 million. Our continued revenue growth and prudent expense management allowed us, in late January 2023, to use approximately $162 million of our cash to acquire FYCOMPA without any dilution to financials. We believe our strong cash position continues to allow us such financial flexibility to execute on our current programs and strategic initiatives.

Thanks, Ali. We entered 2023 focused on growing and diversifying our revenues, strengthening our position within the neuroscience space with our sights set on further expansion, and serving our patient communities. We have all the elements in place for another strong year. We are well positioned to drive sustainable growth that aligns with our core mission to deliver value to our patients, health care providers, and shareholders. Finally, I thank all of our employees for their continued dedication and commitment to positively impacting patients' lives. At this time, I'd like to turn the call over to the operator to open the line for questions.

Thank you. Our first question comes from Joe Catanzaro with Piper Sandler.

Thank you for taking my questions, and congratulations on the successful quarter. I have two quick questions regarding FIRDAPSE. You mentioned there are about 1,000 unique patients since the launch, which has been over approximately four years. What does this number indicate about the penetration into the total LEMS market? Additionally, Steve, I believe you mentioned that some patients are already on the 100 mg dose. Can you share what percentage that represents and what your expectations are for the percentage of patients currently on 80 mg who might increase to 100 mg if that label is updated in the future? Thank you.

Jeff, do you want to take the first question, please, and then I'll turn it over to Steve.

Sure. Hi Joe. The question about penetration of the total population, we feel the penetration is around 25% right now. There is significant opportunity remaining because if you look at the total population of about 3,000 patients and unfortunately some of these patients passed away and new patients are diagnosed. While there's about 25% penetration, like I mentioned, very optimistic and confident about the continued growth sustainability.

Steve, do you want to take the 100 milligram?

Yes. Joe, we haven't actually publicly disclosed the number of patients on the 100 milligram dose because it requires the physicians to work independently at Catalyst to get authorization to move to that dose. It's not a very large number, but there are some patients who are on the 100-milligram daily dose. With regard to the number of patients on the 80-milligram dose, I really don't want to speculate on that. All I can say to you is that about 40% of the patients are on 80. We believe a portion will move to 100. Some patients on 60 may move to 80 as well.

Okay, got it. That’s helpful. Thanks for taking my questions.

Thank you. Our next question comes from Charles Duncan with Cantor Fitzgerald.

Hi, this is Pete Stavropoulos on for Charles. Hi Pat team, congratulations on all the progress for the quarter. I just have a couple of questions that relate to FYCOMPA. The first is, can you discuss your strategy for reinvigorating the brand and how can or will Catalyst leverage the company's current infrastructure for the FYCOMPA franchise?

Great, thank you. Jeff, do you want to take the reinvigorating the brand?

Sure. First and foremost, our priority is to fully integrate the epilepsy franchise with the FYCOMPA personnel. That's what we hope to do by midyear. When we take over the sales and marketing on May 1st, we are going to focus on applying the resources to the physicians that are currently prescribing FYCOMPA, the ones that are new to brand. There are about 6,700 targets that we'll be focusing all of our resources on, and that's how we've surpassed our sales force. So hopefully, that gives you a little bit of insight into how we're going to do this. We'll be more prepared to share our business approach during our next conference call, our earnings call in May.

Yes, and as Jeff pointed out, there's about a 45% overlap between the call points for FIRDAPSE and FYCOMPA, and we don't want to confuse things out of the gate. But when the transition is completed, we expect in the second half of the year that the reps for FYCOMPA and FIRDAPSE will actually carry both products.

I just want to add one comment about the medical sales liaisons as well. I mentioned earlier in the call that we are adding up to six medical sales liaisons, who will be doing a lot of efforts to educate the physician community on FYCOMPA, particularly the safe use of FYCOMPA.

Alright, thanks. Second question I have is what's the potential for developing FYCOMPA in rare epilepsy indications?

Yes, this is Pat. Thank you for the question. We aren't quite ready to discuss that right now. We are still familiarizing ourselves with the program and the full potential for addressing rare epilepsies. There was a recent paper published in Epilepsia, which Steve mentioned, and it's available online. I recommend checking it out. However, we will have much more to share during our first quarter call in May regarding additional opportunities where FYCOMPA can be effectively utilized as a treatment for rare diseases.

One thing I also want to add is that FYCOMPA has a very broad label for the treatment of epilepsies, and many of the rare epilepsies fall into that category. Our MSL team will be educating the physicians on which specific types of genetic epilepsies that can be successfully treated with FYCOMPA.

Alright, thank you. Thank you for taking our questions.

Thank you. Our next question comes from Joon Lee with Truist Securities.

Good morning. This is Les on for Joon. Thank you for taking my questions. First question is for Jeff. Could you quantify how many antibody tests were provided and utilized by physicians, perhaps in Q4, and how has that trended? And then specifically in the small lung cancer patient population, what drivers would push for that additional testing?

Les, thanks for the question. I'll turn that over to Steve.

We haven't actually provided any specific numbers of patients treated with the antibody test. However, it is increasing significantly. We have visibility to how the test is being utilized, and it has been increasing significantly.

I'll add to that too. Starting in the fourth quarter of 2021, we saw a significant increase in the number of BGCC testing done, and then you saw that number carry through 2022. So we're seeing consistently high levels of the BGCC tests that are done compared to previous years. As for the small cell patients, our approach is to work with top small cell academic institutions and include the paraneoplastic panel in their protocols, so that when small cell lung cancer patients get diagnosed, it includes the BGCC antibodies. That's our approach and more of a top-down approach.

That is helpful, thank you for that. Perhaps with Steve, it appears the reasoning on the 100 milligram dose is primarily from patient feedback. Other than safety, what data do you plan to present to the regulators, and essentially, what does the higher dose impact your pricing strategy?

I'll let Jeff and Pat discuss pricing. Regarding our strategy, I want to remind you that when RUZURGI was available before the FDA pulled it, it was approved for doses up to 100 milligrams. We will utilize all the data within the NDA reserve as part of our supplemental NDA to potentially raise the maximum daily dose to 100 milligrams. As I mentioned earlier on the call, we have several patients currently using the 100 milligram strength of FIRDAPSE, and all of that safety data will also be incorporated. We believe that this data will provide enough evidence for the FDA to allow us to request an increased maximum daily dosage of FIRDAPSE.

And Les, regarding pricing, remember it is dose-related, and our typical adult patient is on about 60 milligrams per day. Our net price after discounts and rebates for that patient is around $375,000. You could extrapolate from there with regard to what the pricing might be.

Great, that's very helpful. And then last one for the team, I guess, on the regulatory process in Japan, could you go over that? And if all goes well, how soon can DyDo enter the market in Japan and what's the strategy for the peripheral countries? Thank you.

Yes, I'm limited by what I can say because our partners don't disclose much to the public markets. I'll just generally go over the process that happens in Japan. As I said during the call, they're collecting safety data from their ongoing safety follow-up phase. Upon completion and collection of that data, the next step is to file the NDA in Japan, which I mentioned will be in 2024. As an orphan drug, the review cycle time in Japan for an NDA is about six to eight months, so I would anticipate approval towards the end of 2024, provided, of course, their NDA is acceptable to Japanese authorities.

Thank you.

Thank you. Our next question comes from Scott Henry with ROTH Capital Partners.

Thank you and good morning. Congratulations on a strong year. I have a couple of questions. I understand you may not want to share too much, but regarding the three patent filings, do you know if there is a first filer among those three?

Steve, do you want to take that?

Sure. The short answer is, yes, that's public information. All three of them are first filers; they are all tied for first.

Okay, great. Thank you for that. A couple of other questions, with the shift from the 80 mg to the 100 mg dose, would you expect to see some revenue creep upward per patient? Higher doses often generate higher revenue per patient, just want to make sure that is correct?

Scott, I'll turn that over to Jeff.

Yes, Scott. We do anticipate that the average daily dose will increase for our patients. I've mentioned before, our average daily dose is about 61 milligrams right now. We do have feedback from health care providers and patients asking for the benefit of going above 80mg if that was within the label. With that, we anticipate the average daily dose to creep up over time.

Okay, thank you. And then FYCOMPA, I believe, $130 million in revenues in 2023 guidance. Should we just allocate that over 11 months or are there any trends we should expect there?

We're in the process of the transition, Scott, and we expect full integration to be completed by midyear. I would expect the run rate to increase sequentially over the year. Remember, it's a mature product that's been in the market for 9 to 10 years and has a very established base, and we're looking to grow the product.

Okay, thanks for that color. And Pat, if I break out the FYCOMPA revenue from your overall guidance, you get to $245 million to $255 million for FIRDAPSE. Q4 was $60 million, and it sounds like Q1 is better than Q4. So is it accurate to say you might be conservative or expecting a flattening?

For FIRDAPSE, you're talking about, Scott? Yes, I think the trend will be typical as it has been. Last year's first quarter was impacted by the resolution of the 11th Circuit Court when the approval for the RUZURGI pediatric indication was overturned. We think it's going to be a tough comparison for the first quarter. But as Jeff pointed out, we have continued to enroll new patients in Catalyst Pathways that are naive to either product, and just continuation rates are down. We want to continue to see that. So we think we'll have a typical year quarterly, sequentially up each quarter.

Okay, great. And then just a couple of clerical questions. First, the cash is significant. I guess, I don't want to get into predicting interest rates, but it sounds like you're probably generating around 4% on that for the interest income line, is that a reasonable assumption?

Your first question was about where we've invested our remaining cash, and we've been very conservative and typically invested in 90-day T-bills. You’re right; it's what a difference a year makes. Today, I would say our blended yield right now on our 90-day T-bills is somewhere between 4% and 5%. It's going to be hard to predict going forward. We believe we're in a good spot right now because we anticipate generating a lot of cash this year, again, with FIRDAPSE and FYCOMPA.

Yes, regarding the tax issue, as we mentioned, our effective tax rate for 2022 was 21%. We've fully utilized our federal net operating losses and state net operating losses. We do expect a more normalized 23% to 25% rate in future periods.

Yes. I would say that starting midyear last year, Scott, we guided that we anticipated a more normalized 25% tax rate going forward, and that's going to vary according to state taxes we pay and option exercises.

Okay, great. Thank you for taking the questions.

Thank you, Scott.

Thank you. It appears we have no further questions at this time. With that, I would now like to turn the floor back over to Patrick McEnany for closing comments.

Thanks, everyone, for joining our call. We look forward to our next corporate update and have a great day. Thank you.

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.