Good day everyone, and welcome to the Catalyst Pharmaceuticals First Quarter 2025 Financial Results Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] Please note, this call is being recorded and I will be standing by, should you need any assistance. It is now my pleasure to turn today's program over to Mike Kalb, CFO. Please begin.

Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's first quarter 2025 financial results and business highlights. Leading the call today is Richard Daly, Catalyst's President and Chief Executive Officer. We are also joined by Jeff Del Carmen, our Chief Commercial Officer. Further for the Q&A session, Dr. Steve Miller, our Chief Operating Officer and Chief Scientific Officer will be available for questions. 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 not prove 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 recent 2024, Annual Report on Form 10-K filed with the SEC on February 26, 2025, and our first quarter 2025 quarterly report on Form 10-Q, which was filed yesterday, May 7, 2025 with the SEC. At this time, I’ll turn the call over to Rich. Rich?

Thanks, Mike. Good morning, everyone, and thanks for joining us. Catalyst delivered an outstanding start to 2025 with continued excellent execution, strong demand for our rare disease therapies and continued progress on key strategic priorities. These results highlight our sustained momentum and growing impact in the patient communities we serve. Total net revenues grew 43.6% year-over-year to $141.4 million with meaningful contributions from each of our products. These results highlight the strength of our portfolio and the effectiveness of our commercial execution. With a strong cash position of $580.7 million and disciplined operational management, we are well-positioned to drive long-term growth while advancing our strategic priorities. Let’s turn to the specifics of our commercial performance beginning with FIRDAPSE. FIRDAPSE continues to demonstrate outstanding performance maintaining its position as the only evidence based approved product in the U.S for the Lambert-Eaton myasthenic syndrome or LEMS. In the first quarter of 2025, the brand delivered another strong quarter of organic growth generating revenue of $83.7 million, an increase of 25.3% year-over-year. Performance was driven by continued adoption among newly diagnosed patients and a modest tailwind from normalized prescription activity following temporary disruptions related to the Change Healthcare cybersecurity incident in quarter one 2024. The effect of which we expect to level out in Q2 2025. Mike will discuss the impact of Change Health cybersecurity incident in more detail in his remarks. In addition, since the 100 milligram label expansion for FIRDAPSE approved in May 2024, we've seen an increase in the average daily dose of FIRDAPSE. The 100 milligram enhancement offers providers greater flexibility to individualized therapy based on patient needs. We expect the average daily dose to increase in the near-term. As we've stated in the past, approximately half of all LEMS diagnoses are associated with cancer, in particular small cell…

Thanks, Rich. Good morning, everyone. Q1 marked another record quarter for our commercial organization, reflecting strong execution across the portfolio and continued demand for our innovative therapies. As Rich mentioned, Catalyst had an excellent start to 2025 driven by the combination of sustained organic growth of FIRDAPSE, stable revenues from FYCOMPA and the steady adoption of AGAMREE. Q1 total net revenues of $141.4 million positions Catalyst well to achieve our combined 2025 total revenue guidance of $545 million and $565 million. Also, I am pleased to report that we successfully completed the commercial field team restructuring, establishing dedicated sales teams for AGAMREE and FIRDAPSE. This realignment strengthens our focus within each therapeutic area and sets a strong foundation for future growth. Let me walk through key performance highlights by product. First, I will start with FIRDAPSE performance. Q1 FIRDAPSE net product revenue of $83.7 million represents a 25.3% increase quarter over the same quarter last year, a direct result of strong new patient starts and a low annual discontinuation rate of approximately 15%. Prescription approval rates were greater than 90% across all payers, government or private commercial insurers. We continue to see strong leading indicators in April, furthering our confidence in achieving FIRDAPSE full year net product revenue guidance of $355 million and $360 million in 2025. As we look ahead, our strategic growth initiatives remain a key driver for organic growth. We continue to maintain a pipeline of greater than 500 potential LEMS patients in various stages of their diagnostic journey who have not yet started treatment with FIRDAPSE, representing roughly 50% of our new patient enrollments each quarter. Furthermore, we're particularly excited about the opportunity in cancer associated LEMS, where we are expanding our focus to the community oncology channel, which manages the majority of cancer care in…

Thanks, Jeff. Our performance during the first quarter of 2025 has set us on pace for another strong year driven by our solid financial performance, financial discipline and strong execution. With the continued success from the launch of AGAMREE in mid March of 2024, along with the continued performance of FIRDAPSE and FYCOMPA, we have set the groundwork for what promises to be yet another strong year in 2025 and we reaffirm our 2025 full year total revenue guidance that we provided in February. We remain steadfast in our commitment to driving growth, leveraging strategic arrangements and expanding our portfolio to capitalize on emerging opportunities throughout the year. Our total revenues for the first quarter of 2025 were $141.4 million, a 43.6% increase when compared to total revenues of $98.5 million for the first quarter of 2024. Product revenue net for our lead product FIRDAPSE was $83.7 million, a 25.3% increase year-over-year compared to $66.8 million in Q1 2024, primarily driven by an increase in sales volumes, a portion of which is attributed to a delay in patient claims to certain non Medicare payers in certain states resulting from the Change Healthcare cybersecurity incident that occurred in the first quarter of 2024 and was resolved in the second quarter of 2024. The first quarter of 2025 also reflects a small amount of revenue for shipments to sub-licensees outside of the U.S. Product revenue net for the first quarter of 2025 for AGAMREE was $22 million compared to $1.2 million in the first quarter of 2024. As mentioned earlier, AGAMREE was made commercially available in mid March 2024. The results underscore continued growth and increasing prescriber engagement. Product revenue net for the first quarter of 2025 for FYCOMPA was $35.6 million compared to $30.4 million in the first quarter of 2024,…

Thanks, Mike. As you heard throughout today’s call, Catalyst enters the remainder of 2025 with strong momentum, strategic focus and a clear commitment to delivering value across the rare disease portfolio. We are executing with discipline, advancing initiatives that support near-term performance, taking steps to create long-term value and growth. The quarter's results reflect the strength of our execution, the resilience of our model and the depth of the talent across the organization. I want to thank our employees, partners and stakeholders for their continued dedication. As we look ahead, I'm confident in our abilities to drive meaningful impact and sustain value. Thank you for joining us today. I will now turn the call back over to the operator for questions. Thank you.

Thank you. [Operator Instructions] And our first question will come from Joon Lee with Truist Securities. Please go ahead.

Congrats on the quarter and the beat. This is Asim Rana on for Joon. Thanks for taking the question. Just a couple from us. So FIRDAPSE saw a 25% growth from last year. How much of that would you say strengthened this quarter versus weakness in last year's 1Q due to the Change Healthcare impact? And then as a follow-up, can remind us what proportion of FYCOMPA patients are on the tab formulation versus the oral suspension formulation? Thank you.

Asim, thanks for the question. As we alluded to, there was some shift in the business due to the Change Healthcare. I’m going turn it to Jeff to address the question and then Jeff will also address the FYCOMPA question as well.

Sure. Asim, regarding the strength of the business, we always say 15% to 20% growth is what we aim for FIRDAPSE and that’s the range that we fell in Q1. So it's about 15% to 20%. We saw strong enrollments though discontinuation rates and we continue to see great leading indicators in April.

So -- yes, so just to really put a bow on that, if you were to back out the effect of Change Healthcare, you would still be in that 15% to 20% range. Is that right, Jeff?

Absolutely.

Yes. Asim, is that clear?

Very clear. Thank you. And then just on the proportion of FYCOMPA patients that are on the tablets, the oral suspension formulation?

Percent of tablet versus suspension.

It's probably about -- I'm sorry. It’s about 15 -- I'm sorry. It’s about 98% tablet.

Okay. Thank you. Very helpful.

You're welcome.

Thank you. Our next question will come from Samantha Semenkow with Citi. Please go ahead.

Hello. This is Benjamin Paluch on for Sam. Thanks for taking the questions. How is the uptake of FIRDAPSE among small cell lung cancer patients trending? Are you seeing an impact from your patient screening efforts in this population? And how should we think about growth from small cell lung cancer versus idiopathic patients over the next several quarters?

Thanks for the question, Benjamin. I’m going turn it over to Jeff.

So our current mix for all our LEMS patients currently on FIRDAPSE about 20% to 25% are cancer associated LEMS patients. Our goal for this year is to really focus on our VGCC antibody screening arrangements with GPOs and community oncologists. So with that, again, we want to focus on screening and helping these patients that about 90% of small cell lung cancer patients with LEMS are currently undiagnosed. So our goal is to help them get diagnosed. And in 2026 is that’s when we will be able to help patients transition onto therapy. So that's our goal. In the long-term, we expect that 20% to 25% to grow to potentially 30%, 35%.

Thank you.

Thank you.

Is that helpful, Ben? Okay, great.

Our next question will come from Joel Beatty with Baird. Please go ahead.

Hi, congrats on the quarter and thanks for taking the questions. The first one is on business development activities. In the past, you've put a lot of focus on that. I guess, we're currently in what a lot of people are describing as a rapidly changing macro environment. And so what are your current thoughts on business development? Are there any recent impacts on that?

Thanks for the question Joel. So we remain focused on our strategy which is looking at immediately accretive or nearly immediately accretive opportunities. So the dynamics in the market are many fold as we point out. We see this as a really beneficial opportunity for us. We continue to see inbounds at about 80%. So the opportunities that come to us or the opportunities we are assessing, 80% of them are coming to us, de novo. So we like that. The capital markets, while they are in turmoil, we think present an opportunity for us, which we like as well. And then because of our strategy looking at opportunities that are near the finish line and going commercial, we think this remains relatively unaffected by the regulatory environment and changes in the regulatory environment. So we see this again as beneficial for us in the strategy that we have. So while it's unsettling, think in general, for our strategy, I think it reinforces our strategy. So we feel good about where we stand as a company and the strategy that we have.

Great. That's helpful to hear. And then as a follow-up on FIRDAPSE, for cancer associated LEMS, any anecdotes or things that you've seen working at a smaller scale perhaps that helps give you confidence and the strategy that you are taking to increase the diagnosis rates with the antibody and see that lead to treatment?

So when you say smaller scale, can you clarify?

I mean, is this something that you've maybe been able to kind of test in certain locations or trying to get into the antibody tests? Are we still kind of early in these efforts? But just anything, right, this is a -- or maybe another way to ask is that you've had a lot of success in non cancer associated LEMS marketing, but this is a different approach. So what kind of gives you confidence that you can be successful in this setting as well?

Great. Okay. So I think let me start and then I will turn it over to Jeff. So I think what you are asking is, have we -- in our dialogue with the oncology community, have we seen interest in this? And the answer is a definite yes. We are talking to these larger groups and there's been a consolidation of these oncology practices in larger groups and our dialogue with these oncology groups we are seeing, a definite interest in this because they realize that as Jeff has alluded to in previous discussions, 90% of the patients with small cell lung cancer associated LEMS are not getting treated. And so they see the dynamic, they see the unmet clinical and medical need. And so when we talk to them about it and the ability to diagnose and then thus treat with a definitive treatment, there is a definite interest. But Jeff, you’re closer to the subject. Do you want to address it?

Absolutely. There have been significant ad boards that have been done with these thought leaders over the last year or 2 years. So like Rich mentioned, significant interest among these key opinion leaders. And also, our goal is to help provide frictionless testing for these patients so that these 90% of patients that are undiagnosed can get tested and hopefully diagnosed. And in our -- in those discussions, these physicians, again, they see the unmet need for these small cell lung cancer patients. So there's significant interest out there in the oncology community.

Okay. Thank you.

Joel, is that helpful.

Yes, it was.

I just want to correct one thing. I believe I misspoke before when the question came up about the split between oral and solid tablets. It’s actually 85%. So I apologize. So it’s 85% are tablets and 15% is oral solution on FYCOMPA. So my apologies to the group.

Thank you. Our next question will come from Charles Duncan with Cantor Fitzgerald. Please go ahead.

Hey, good morning, Rich and team. First of all, congratulations on the first quarter performance. Secondly, thanks for taking our question. I had a question on FIRDAPSE. And in the guidance that you’ve given, it’s uncommonly tight. And I guess I'm wondering, you’ve been tracking like 500 patients for several years and about half of them or I guess the new to brand or new patient starts come from that pool. I'm wondering if you could give us some color on how you’re setting that guidance. If I look at, call it a 15% growth thus far this year, that’s closing in on 390 not 360. So I’m wondering what is the source of your conservatism with regard to FIRDAPSE guide?

Source of our conservatism, Charles?

Yes. I mean in terms of new patient adds or persistence or growth in average daily dosing, where do you stand on what the most important trigger there is?

Okay. Jeff, do want to take that?

Yes. Hey, Charles. Good morning. As far as what I can talk about are the leading indicators for us in our core business. And we've seen it over the last 15 quarters now that 15% growth. And like you mentioned the 500 patients or so that are pipeline patients that are somewhere in their diagnostic journey for LEMS, We have significant resources or sources to find continue to backfill the patients after they get on therapy to find new leads so that we always have about 500. Our discontinuation rates remain low at 15%. Over time we see what our trend is for our net new patients each month, any given quarter. So that’s what helps inform us about where our growth is and our confidence. So this is our sixth year out. So we kind of understand where the trend is and where we are headed. So that’s what gives us the confidence. Hopefully that helps Charles. I don’t know if there’s any a follow-up question that you can ask that can point me in the direction that you want me to go.

No, I think that that's good. I understand the confidence, but I definitely think it's conservative my perspective. Maybe we’ll move on to FYCOMPA and that is you mentioned measured revenue decline and that makes sense for an epilepsy indication. You said that this year you have measures in place. Could those measures also apply to next year? I know you are not guiding to next year, but is it inherent in the use of FYCOMPA that use may continue for those patients into next year?

Charles, there tends to be a stickiness for lack of better terms for anti seizure medications. So there is an opportunity there for patients to or to minimize brand erosion over time. We haven't given that guidance as you mentioned for next year. But yes, I mean there is an opportunity to minimize brand erosion continuing into next year.

I think the challenge with that Charles is that the 6-month exclusivity period ends at the end of this year and then we probably don't know, we would expect additional generics to enter the market. And at that point, while we haven't, as Jeff has alluded to, we haven't given guidance for 2026. We all know the way that prices inversely proportional to the number of players in the generic market. So, I think it just becomes tougher to control.

Okay .Last question on biz dev [ph], helpful color so far. But in terms of the market and the environment, it does seem like it favors your approach and your cash position. I'm wondering if you have specific goals for this year to get a transaction done? Or is that something you don’t want to commit to at this point?

I would -- wouldn't say we have a specific goal to get a transaction done. We have a specific goal to get the right transaction done or right transactions done. I think we've been very, very good as a company in bringing in the appropriate assets and we want to continue that trend. We want to make sure we bring in the right assets. We've looked at a lot of opportunities and for a number of reasons they don't fit us and they don't make sense for us. It would be unfortunate for us to bring in an opportunity that didn't fit us culturally, financially, structurally. And so all of those things have to fit. And we are, I think, a very discriminating buyer of assets and acquirer of assets. And we want to continue that because we think that's beneficial for shareholders and beneficial for us as a company. And so I'm not trying to parse words, but we have a goal to do the right deal.

Okay. Thanks for taking all my questions.

Thanks for your support too as well.

Thank you. Our next question will come from Rohan Matur with Oppenheimer. Please go ahead.

Hey, this is Rohan on for Leland Gershell. Thanks for taking the question and congrats on another really strong quarter. Just one for me on the AGAMREE. As you see the SUMMIT Study progress, what aspects of the AGAMREE's profile do you think will resonate most with prescribers, especially those who have yet to incorporate it into their own practice? Thank you.

Thanks, Rohan. Gary, we have Gary Ingenito, our Chief Medical Officer on line. Gary, do you want to take that question?

Thank you, Rich. Yes, Rohan. I think that the demonstration of bone health, bone density and the effects on cardiac will be some of the key findings that confirm the differentiation of AGAMREE, which we see based upon our preliminary data and we will do it again in the long-term with the real world evidence.

Got it. And just a follow-up, how do you sort of plan to quantify that in SUMMIT?

So in SUMMIT, we will be looking at fracture rates, bone age, bone density and development or prevention of cardiomyopathy.

Thank you.

Thank you.

Thanks, Rohan.

Our next question will come from Jason Gerberry with Bank of America. Please go ahead.

Hey, guys. Sorry, I joined late and missed everything so far on the call. So apologies if this has been addressed. But just can you remind me with the strength of the FIRDAPSE quarter, just wondering if there’s any pull forward at all. Just trying to think through the quarterly progression of sales. And furthermore, if you can speak to, whether you are starting to see strength in performance of the small cell lung adoption on the LEMS side there? Thanks.

Jason, thanks. So Mike -- we will turn that first part of the question over to Mike and then we will turn the second part of the question over to Jeff.

Yes. Hey, Jason, thanks for the questions. Thanks for the support. On FIRDAPSE Q1 and we did note it, I would look at it as let’s start with we've said consistently 15% to 20% growth and we maintain that notwithstanding the strong growth in Q1. Some of the Q1 '25 compared to Q1 '24 is actually the Q1 '24 Change Healthcare cybersecurity incident and that impact timing into Q2.

So if you back that out, Jason -- just to clarify, if you back out what happened in 2020 -- Q1 '24 we are still in the range of a growth of 15% to 20%. Is that helpful?

Yes, definitely.

Great. And then, you just ask the second question so we are all clear on where we stand for your second question?

Yes. Just how 1Q may have been impacted at all like sort of the momentum you’re seeing on small cell lung LEMS pick up relative to I guess baseline or year-on-year comp?

Sure. So Jason, let me get you baseline where we are at. It’s about 20% to 25% of our current FIRDAPSE patients are cancer associated LEMS patients. Our main focus this year is to get BGCC antibody screening arrangements in place with community oncologists, GPOs and where we expect to see growth in the percentage of our patients to be cancer associated LEMS patients will be in 2026 and beyond. So that's where we expect the opportunity to be realized more. So again, this year we are hopeful that we can help those 90% of patients that are currently undiagnosed, the small cell lung cancer LEMS patients that are undiagnosed, we want to help them get tested and diagnosed.

Got it. Okay. Thanks so much.

Thanks, Jason.

Thank you. Our last question will come from Sudan Loganathan with Stephens. Please go ahead. Sudan, please make sure that you are not muted.

I'm sorry. Congrats on the call. This is Felix for Sudan Loganathan. I have a quick question on FIRDAPSE. Given the high percentage of the undiagnosed LEMS patients, can you please give us color in terms of the proportion of the penetration that you have so far on FIRDAPSE? And what will contribute the percent penetration to increase given that you have initiative to increase diagnosis?

Thanks for the questions. So we've said recently at JPMorgan in our conference, we said we believe that size of the market is about $1.2 billion, in today’s prices, so no price increases, et cetera. If you just look at our sales last year about 300 [technical difficulty] that would mean we have about a 25% market penetration across the board. So we believe there's significant upside in this market for us. And this consistent growth that Jeff alluded to the 15% to 20% we've experienced for some time, we believe that we can sustain that. And given this cancer associated LEMS initiative and continuing to push on the idiopathic side or non cancer associated LEMS, we believe that there is a significant opportunity to continue to grow this market and we are really excited about it. Jeff, any comments?

So like Rich mentioned, I mean significant opportunity on both -- in both segments of the LEMS prevalence. We expect to see more opportunity to help the small cell lung cancer LEMS patients moving forward. Right now the idiopathic LEMS, the penetration is strong. However, there's still plenty of opportunity. The 500 or so pipeline patients, those patients that are somewhere in their diagnostic journey, the vast majority of those patients are idiopathic LEMS patients. So we have plenty of opportunity to help them in the short-term as well. So both segments significant opportunity remaining.

Thanks, Jeff. Appreciate it. Any other questions?

Thank you. No questions from my side. Thank you very much.

Thank you. Thank you.

Ladies and gentlemen, this does conclude today’s program, and we appreciate your participation. You may disconnect at any time.