Catalyst Pharmaceuticals, Inc.

Greetings, and welcome to the Catalyst Pharmaceuticals Third Quarter 2025 Financial Results Conference Call and Webcast. At this time, all participants are in listen-only mode. A question-and-answer session will follow a formal presentation. You may be placed into question queue at any time by pressing star 1 on your telephone keypad. We ask that you please ask one question and one follow-up, then return to the queue. If anyone should require operator assistance, please press star 0. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Chief Financial Officer Mike Cowell.

Mike, please go ahead. Thank you. Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's third quarter 2025 financial results and business highlights. Richard Daly, President and CEO, will lead the call today, and Jeffrey Del Carmen, our Chief Commercial Officer, and I will also present. Additionally, Dr. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer, and Dr. Will Andrews, our Chief Medical Officer, will be available for the Q&A. Before we begin, I'd 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 reflect our current expectations, estimates and projections and do not guarantee 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 2024 annual report on Form 10-K, filed with the SEC on February 26, 2025, and in our subsequent filings with the SEC, including our third quarter 2025 quarterly report on Form 10-Q, which was filed yesterday, November 5, 2025, with the SEC. At this time, I'll turn the call over to Rich. Rich?

Thanks, Mike. Good morning, everyone, and thank you for joining us. Today's call will begin with an overview of our portfolio highlights and key strategic growth initiatives, followed by a detailed discussion of our commercial performance and financial results for the quarter. Catalyst delivered outstanding third quarter 2025 results with accelerating momentum, strong demand for our rare disease therapies, and continued progress on key strategic growth priorities. These results highlight our growing positive impact on the patient communities we serve and demonstrate our unwavering commitment to operational excellence and delivering long-term value. Catalyst reported another record quarter in Q3 2025, with total revenue reaching $148.4 million, an increase of 15.3% year-over-year. These results were driven primarily by outstanding performance of FerdApps and the growing success of Agamri, along with extended patient preference for Phycompa following generic entry. We ended the third quarter of 2025 with a cash position of $689.9 million and no debt, further reinforcing our ability to invest strategically for long-term growth. Last month, we announced that our board of directors authorized a new share buyback program to repurchase up to $200 million of shares of Catalyst's outstanding common stock between October 1st, 2025 and December 31st, 2026. As mentioned, we believe that we can execute this share repurchase program without impairing the advancement of our business development strategy. Further, We believe that this repurchase program will enable us to provide value to our shareholders, and we are increasingly confident in our long-term outlook. With our strong performance over the first three quarters of the year, we are raising our 2025 total revenue guidance to between $565 million and $585 million. Let's start with FerdApps. BirdApps continues to demonstrate outstanding performance, maintaining its position as the only evidence-based approved product in the U.S. for the treatment of Lambert-Eaton myasthenic syndrome. The brand delivered another strong quarter of sustained growth, generating revenue of $92.2 million, an increase of 16.2% year over year. We are confident that Ferdaps remains well-positioned for sustained organic growth across both idiopathic and cancer-associated LEMS markets. Supported by a robust pool of patients and individuals progressing through their diagnostic journey, this strong and visible demand underscores the durability of the franchise and reinforces our leadership in addressing the needs of the LEMS community. Jeff will go into more detail about our growth strategy in these distinct markets in his remarks. Since we believe that potentially 90% of cancer-associated LEMS patients remain undiagnosed, we see a meaningful opportunity to expand our reach in this high-potential, underserved population. We expect momentum to build in the months ahead, setting the stage for sustained growth in 2026 and beyond. We remain confident that we'll meet our full-year total net product revenue guidance for FRDAPs of between $355 million and $360 million. Jeff will cover the specifics in his section of the call. Moving on to Agamri. While FredApps continues to perform incredibly well, we're equally encouraged by the market potential and performance of Agamri. Agamri continues to outperform expectations, generating $32.4 million in net product revenue in Q3 2025. a 115.2% increase year-over-year from Q3 2024. These results are largely driven by steady conversion from both prednisone and influenza, a strong 90% patient retention rate, and growing adoption across virtually all of the DMD centers of excellence around the United States. Agamri's commercial execution continues to track well with strong patient retention and increasing prescriber engagement, further supported by recent full deployment of our dedicated field team back in April. Continued transitions from both branded and generic therapies along with growing market receptivity and payer alignment due to an increased appreciation for Agamri's potential differentiation from the current standard of care reinforce our confidence in raising full-year outlook to between $105 and $115 million. Catalyst continues to actively enroll patients in the summit study, an open-label, five-year follow-up study designed to evaluate the long-term clinical safety profile of a gamary, including potential benefits on behavior, stature, bone health, and cardiovascular health. Finally, let's take a look at Phycompa. Phycompa delivered higher than anticipated results in the third quarter of 2025 with revenue of $23.8 million, which reflects a year-over-year decrease of 25.8%. This performance was driven in part by patients electing to stay on their existing treatment plan following generic entry for Phycompa tablets in Q2 2025. Although we anticipate the impact of generic entry to increase going forward as other entrants eventually come to the market, we are raising our full year net product revenue guidance for this product to between $100 and $110 million. Now I'd like to reiterate what we believe sets us apart. Catalyst's competitive advantage is built on the strength of not only our field efforts from both our sales and medical teams, but also our patient engagement services that we offer through Catalyst Pathways for patients taking Ferdaps and Agamri. Catalyst Pathways is our personalized treatment support program for patients who are enrolled in the program and serves as a single source for personalized treatment support, education, and guidance to the dosing and titration regimen required to reach an effective therapeutic dose for each patient's therapy. We believe that navigating the healthcare system with this support is far better for patients needing treatment for their rare diseases and for the healthcare community in general. Finally, our strong relationship with healthcare and rare disease communities continues to drive meaningful stakeholder engagement. Together, our single source approach enables the patients we serve to streamline access, identify appropriate therapy, receive timely treatment, and remain compliant with their care. We believe these differentiating capabilities will enhance prospects for creating uncommon value for our current patients and for other rare disease patients in the future. Let's turn to business development. We remain highly disciplined in our business development strategy, and we continue to actively evaluate a broad range of opportunities, many of which are inbounds, reflecting growing awareness of the value we create for patients in need We also have an aggressive outreach initiative resulting in over 100 assessments since January. The support services that we have developed through Catalyst Pathways for patients who are taking Ferdax and Agamri are industry leading and can be applied to any rare therapeutic area. So we remain therapeutic area agnostic. We believe our integrated infrastructure with our sales teams identifying potential patients and Catalyst Pathways providing direct support to patients, getting the patients on therapy, keeping them on therapy, and ensuring the patient receives the optimum dose are important components of our continued success and our core capabilities that we see as not universally available through other companies serving patients living with rare diseases. Now for an update on IP. We continue to advance initiatives to protect long-term value for our portfolio. On August 26th, we announced the settlement of our pending 4DAPS patent litigation with Lupin As part of the settlement, Lupin received a license to market generic Ferdaps beginning in February of 2035 on the same market entry date as Teva Pharmaceuticals had previously agreed to in their settlement. This settlement leaves only one patent case still pending against Hetero USA Incorporated. The trial date has been set for March of 2026, which is prior to the expiration of the automatic 30-month stay set for May 26 of 2026. I'd like to reiterate my previous comment. As we have consistently stated, we will vigorously defend our IP for all of our products. With that, I'll turn the call over to Jeff, who can provide additional insights into our commercial performance. Jeff?

Thanks, Rich. Q3 2025 marked another record-setting quarter for our commercial organization. generating net product revenue of $148.4 million, a 17.4% increase compared to Q3 2024. These results highlight continued strong execution across our portfolio and sustained demand for our differentiated therapies. As Rich noted, Catalyst again delivered organic growth from Ferdaps, continued adoption of Agamri, and stronger than expected revenue from Phycompa. Our Q3 2025 net product revenue underscores the strength and resilience of our rare disease platform. Ferdapps continues to deliver sustained organic growth. Q3 2025 revenue results of 92.2 million reflect its robust growth trajectory. driven by durable demand and continued execution of our growth strategy, resulting in 16.2% growth in Q3 2025 compared to Q3 2024. New patient enrollments exceeded forecast. Prescription approval rates remained above 90% across both government and commercial payers, and discontinuation rates were in line with expectations tracking below an annualized rate of 20%. These indicators reflect strong patient adherence and reinforce the foundation for sustained performance. Leading indicators, including new patient starts and refill volumes through October, continue to trend positively, reinforcing our confidence in achieving our full-year 2025 FERDAPs net product revenue guidance of between $355 million and $360 million. Our next phase of growth for FERDFs will come from both idiopathic LEMS and cancer-associated LEMS. For idiopathic LEMS, we continue to advance our patient identification efforts by augmenting data sources, further expanding the pool of over 500 LEMS patients in active diagnostic stages. With a dedicated sales force of 16 regional account managers and enhanced lead optimization efforts that better target patients most likely to initiate Ferdapp's treatment, these patients now represent over 50% of new starts each quarter, strengthening our confidence in sustaining future organic growth. In addition, we have intensified efforts. to expand VGCC antibody testing among patients often misdiagnosed with myasthenia gravis, which remains the most common misdiagnosis for LEMS patients. We have seen sustained VGCC antibody testing growth of 9% quarter on quarter over the last two years. With only approximately 30% penetration on the idiopathic side of the LEMS market opportunity, we have clearly identified the potential sustainable growth. Our expansion strategy for cancer-associated limbs is sharply focused on multiple critical levers, broadening access to BGCC antibody testing and streamlining the diagnostic pathway, now further reinforced by the recent NCCN small cell lung cancer guideline update on July 25th, and our efforts to update the oncology care pathways and expanding HCP education on those updated pathways. As Rich mentioned, we are continuing to execute on those fronts. First, we have launched a frictionless testing model designed to remove referral bottlenecks and accelerate the time to diagnosis. Second, the updated NCCN guidelines now include VGCC antibody testing and recommend amifampradine the only evidence-based approved treatment for patients with LEMS, potentially providing a strong tailwind for market adoption. Third, we are pursuing new collaborations with leading oncology networks to integrate these updated NCCN guidelines into their care pathways. Lastly, we continue to expand our footprint across the community to educate those concentrated oncology centers on the updated care pathways. With over 90% of cancer LEMS patients still undiagnosed, the unmet need remains significant. We see a clear opportunity to drive awareness, increase access, and deliver meaningful impact across the LEMS community. As we move forward, we're executing with precision to accelerate diagnosis, increase adoption, and position FERDAPs for sustained momentum through 2026 and beyond. Turning to Agamri. Agamri continues to demonstrate strong market momentum as a differentiated therapy for Duchenne muscular dystrophy. In the third quarter of 2025, we generated net product revenue of $32.4 million, a 115.2% increase over the third quarter of 2024. Adoption is expanding steadily across key treatment centers. To date, Each of the top 45 DMD centers of excellence have enrolled at least one patient on a GAMRI, and 255 unique healthcare providers have submitted enrollment forms, reflecting broad and growing engagement across the community. Since launch, approximately 43% of patients being treated with a GAMRI transitioned from prednisone and 41% from influenza. highlighting Agamri's broad clinical relevance across established treatment segments. Reimbursement performance remains robust, with success rates above 85%, in line with our expectations. Our commercial team continues to execute effectively, driving targeted provider education and deepening payer engagement to support durable uptake and sustained market expansion. Given the continued strength of these trends, we are raising our full-year net product revenue guidance for Egamri to a range of between $105 million and $115 million. Finally, FICOMPA delivered Q3 2025 net product revenue of $23.8 million, reflecting continued demand following the first generic entry for tablets in late May. We remain cautiously optimistic on FICOMPA brand loyalty and based on stronger than expected performance in the first nine months, we are raising full year 2025 FICOMPA revenue guidance to between 100 and 110 million. As previously noted, we do expect continued revenue erosion from generic competition to impact FICOMPA performance in Q4 and beyond as more generics enter the market. In summary, our commercial team continues to execute with strong discipline and focus, delivering robust portfolio performance and advancing our next phase of growth. We are confident that our diversified portfolio, best in class commercial capabilities, and focused execution position us well to capture the significant growth opportunities ahead. As we look to close 2025, our priorities remain clear. driving commercial excellence, broadening patient access, and maximizing the value of our portfolio to deliver sustainable growth and long-term shareholder value. I would like to thank the entire Catalyst team for their continued dedication and commitment to performance, execution, and the patients we serve. At this time, I would like to turn the call back over to Mike.

Thank you, Jeff. Our performance during the third quarter of 2025 has kept us on pace for another strong year, driven by our solid financial performance, financial discipline, and strong execution. Our total revenues for the third quarter of 2025 were $148.4 million, an approximate 15.3% increase when compared to total revenues of $128.7 million for the third quarter of 2024. The third quarter of 2024 included approximately $2.3 million of license and other revenue, which consisted principally of a milestone payment that we earned from our sub-licensee, Daito Pharma, upon its receiving regulatory approval to commercialize Ferdaps for the treatment of patients with LEMS in Japan, compared to license and other revenue in the third quarter of 2025 of $27,000. Net income before income taxes for the third quarter of 2025 were $71.0 million, a 24.2% increase year over year, compared to $57.2 million for the third quarter of 2024. We reported gap net income for the third quarter of 2025 of $52.8 million, or 42 cents per diluted share. Gap net income increased by 20.3% year over year, compared to GAAP net income for the third quarter of 2024 of $43.9 million, or $0.35 per diluted share. Non-GAAP net income for the third quarter of 2025 was $86.1 million, or $0.68 per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FICOMPA, AGAMRI, and RESURGY of $9.3 million, stock-based compensation expense of $5.7 million, the income tax provision of $18.3 million, and depreciation of $100,000. This compares to non-GAAP net income for the third quarter of 2024 of $71.1 million, or 57 cents per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FICOMPA, AGAMRI, and RESURGY of $9.3 million, stock-based compensation expense of $4.4 million, the income tax provision of $13.3 million, and depreciation of $100,000. Our year-to-date effective tax rate through the first nine months of 2025 was 23.6 percent compared to 24.0 percent through the first nine months of 2024. The effective tax rate is affected by many factors, including the number of stock options exercised in any given period and is likely to fluctuate in future periods. Cost of sales expense was approximately $22.7 million in the third quarter of 2025 compared to $19.3 million in the third quarter of 2024 and consisted principally of royalties. As a reminder, the GAMRI royalties paid to the product licensor equal 5% of net sales up to $100 million for 2025 and 7% of net sales in excess of $100 million and up to $200 million, with additional increases as net sales increase. The company is also required to make a $12.5 million sales-based milestone payment once the GAMRI's net product revenue for a fiscal year reaches $100 million. When this occurs, this milestone payment will be capitalized and amortized over the estimated remaining useful life of the asset. Further details on our royalty obligations for GAMRI as well as Ferdaps and FICOMPA are disclosed in our third quarter form 10Q. Research and development expenses were $2.7 million in the third quarter of 2025 compared to $3.3 million in the third quarter of 2024. Our R&D spending in the third quarter of 2025 was comprised mainly of costs to support our two ongoing agamory studies. Selling general and administrative, or SG&A, expenses for the third quarter of 2025 totaled $47.5 million as compared to $45.9 million in Q3 2024, reflecting in part an increase in our cancer-associated LEMS activities. As reported, we ended the third quarter of 2025 with cash and cash equivalents of $689.9 million compared to $517.6 million at December 31st, 2024. This increase in cash of $172.3 million between the end of 24 and September 30th, 2025 was largely driven by $163.8 million in cash generated from operations of the business. This highlights our continued focus on profit optimization and cash flow generation. We believe our current funds along with our expected continued generation of cash from operations, continue to allow us the financial flexibility to fund our existing R&D programs, meet our potential contractual obligations, and support our strategic initiatives, business development, and portfolio expansion efforts, leading to long-term growth and value creation. More detailed information and analysis of our third quarter 2025 financial performance may be found in our quarterly report on Form 10Q, which was filed with the Securities and Exchange Commission yesterday, November 5th, and can be found on the investor relations web page of our website. At this time, I will turn the call back over to Rich. Rich? Thanks, Mike.

As you heard on today's call, Catalyst is closing 2025 with strong momentum and an unwavering commitment to deliver value for the patients we serve. This confidence is reflected in our updated guidance which we raised after careful consideration and with respect to market conditions. This quarter's exceptional results reflect the strength of our commercial execution, the resilience of our business model, and the depth of talent across our organization. I want to thank our employees, partners, and shareholders for their continued support and dedication. As we finish 2025 with ongoing momentum, we look forward to continued success. Thank you for joining us on today's call. and I'll now turn the call back over to the operator for questions.

Thank you. We'll now be conducting a question and answer session. If you'd like to be placed in the question queue, please press star 1 on your telephone keypad. As a reminder, we ask that you please limit yourselves to one question and one follow-up, then return to the queue. If you'd like to remove yourself from the queue, please press star 2. A confirmation tone will indicate your line is in the question queue when you press star 1. One moment, please, while we poll for questions. Our first question today is coming from Samantha Smenko from Citigroup, your line is now live.

Good morning. Thanks very much for taking our questions. And congratulations on the great quarter. First question is on third apps. I'm wondering as you start to penetrate and really put a lot of effort into the oncology portion of the LEMS business, are you able to share any anecdotes or data points that you have thus far that can really help us begin to quantify how those efforts are progressing. And then on Ficompa, do you have a sense of what proportion of the patients are expected to stay loyal to branded Ficompa? I'm just trying to figure out if these additional generics come to the market, how much erosion we're looking at for this fourth quarter. Thanks very much.

Thanks for the question, Sam. For the first one, I'll turn it over to Jeff. Jeff, you want to give us some update?

Hi, Sam. Good morning. As far as the cancer-associated labs and providing maybe some anecdotes or leading indicators on how performance is going, we will do that in future quarters. What we're continuing to do is, like we mentioned on the earnings call, our first goal was really to get that testing in place, which we were successful. Secondly, the updates to the NCCN guidelines, which, again, we were also very successful in doing that, last July, so very pleased with that. Currently what we're doing is we're educating and working on educating physicians and group practices and hopefully partnering with them to change their care pathways and also have screening arrangements put in place. Moving forward when we are successful with those discussions and those partnerships, we will share some of the leading indicators.

So to build on that as well, Oncology is a highly structured and complex marketplace. And so since the NCCN guidelines, which actually gives us the opportunity or license, if you will, to begin those discussions, we got that back at the end of July. And we're really excited about the conversations we're having with the decision makers in the oncology marketplace. It is a process. We are working through it. And we expect, as we've said in the past, that that will deliver results in 2026. I'm just going to move on to your next question, if that's okay. So, Jeff, the FICAPA stickiness, any thoughts on that?

Sure. So, as you see by the revenue numbers that we've reported, FICAPA continues to perform very well. And we do believe a lot of that is from brand loyalty and the stickiness. You know, as additional generics enter the market later this year, we do expect additional erosion to revenues. However, we do also expect some patients to remain loyal to the brand. As far as the specific percentage, we haven't really provided guidance on that. And, you know, we're very confident in our guidance that we did provide.

That's very helpful. Thanks for taking the questions.

Thanks, Sam. Thank you. Next question today is coming from June Lee from Truist Security. Your line is now live.

Congrats on a strong quarter and thanks for taking the questions. This is the last one for June, just a couple for mine. You know, just on the FICOMPA stickiness, you know, why are patients choosing to stay on FICOMPA longer? You know, what do you learn from them? And can you remind us how many generics are currently in the market and how many we could expect by year end? And then just on for that, you know, are you actively seeing oncology practices following the updated NCCN guidelines or would you say that's more of a 2026 story? Thank you.

I'm sorry, could you just repeat the second question? I just lost you for a second.

Yeah, just on Ferdaps, are you actively seeing oncology practices following the updated guidelines, or is that more of a 20-some-six story?

Thank you. Jeff, on the stickiness, obviously, Ficompa is a one-of-one in the marketplace, and then we have one generic in there, so do you want to speak to the potential stickiness?

Sure. So, you know, when you take a look at the generic competition right now for Ficompa, there's one and that's Teva. You know, Teva's generic is at about a 17 plus percent discount to Ficompa. So, you know, it's a relatively good market for us when competing against Teva's product. The stickiness, a lot of patients are afraid that to switch medications for anti-seizure medications. You know, what they don't want is something where a generic one month and then, you know, it's different so that they have a breakthrough seizure. So one of the things that they like to do is stay on the brand that they've been on for the last 10, 12 plus years. So that lends to the stickiness of the product. Also, we still have field personnel for Phi Kappa that are out there talking to many of the physicians that prescribe anti-seizure medications and financial resources to help patients that are on Phi Kappa. So I think all those things contribute to the stickiness, and that's what we've seen in the revenue that we reported. Does that answer your question about Phi Kappa? Yeah. Okay, great. And as far as the NCCN guidelines and, you know, the adoption of those, it is more of a 2026, you know, part of our 2026, that's when we'll see more of the adoption. But it is significant in our discussions with these group practices in getting the care pathways changed and to adopt the NCCN guidelines. So we're starting to see those, those discussions pay off. But again, our goal for 2025 and the remainder of this year is really to accelerate screening for these patients, which will turn into hopefully patients that will be diagnosed with small cell lung cancer limbs next year and then also transition to bird apps.

Thanks, Jeff.

Thank you. As a reminder, that's star one to be placed into question queue. Our next question is coming from Leland Griffith from Oppenheimer. Your line is now live.

Hey, guys. It's Rohan on for Leland. Congrats on another strong quarter. I wanted to ask on the GAMRI if you've seen any changes in the prescriber base. It's been talked about before how as people get more acquainted with longer-term data from the GAMRI and real-world data, more prescribers may be inclined to come on. give their patients a GAMRI? Have you seen any change in the breakdown? There are new prescribers and more so on a GAMRI. Just given the scope of what the differentiated steroid can do, are you exploring any other opportunities outside of Duchenne? And yeah, that's all for me.

Ron, thanks for the question. Jeff, do you want to handle first?

Sure. So for a GAMRI, we're extremely pleased with how the launch has gone thus far. over the last year and a half plus. And we have seen strong adoption. And like I mentioned, you know, the top 45 centers of excellence for Duchenne muscular dystrophy make up about 80% of the steroid prescriptions for boys living with DMD. And each of the top 45 have enrolled at least one patient on a gamma. So that's strong adoption there. When you take a look at the top 100 centers of excellence, We have over 95% penetration in those centers of excellence. So again, broad adoption. And then also we've talked about the adoption across both segments of Prevazone as well as Implaza. So very confident and pleased with that performance thus far. And also the 257 healthcare providers that have prescribed Agamri, at least one patient on Agamri. So again, strong adoption. Now what our focus is to continue to deepen that adoption so that we can get more and more patients within each center on a GAMRI as these physicians see the differentiation of a GAMRI versus the other steroids. So that's our goal moving forward.

On the second question regarding additional opportunities beyond Duchenne's, first we'll turn it over to Will Andrews, our Chief Medical Officer. Will?

Yes. Hello. Thank you, Rich. We are evaluating life cycle management opportunities for consideration of add-on indications for a gamary. And as an example, you can imagine we look at disorders that have muscle inflammation that significantly affect function in patients and even other inflammatory disorders. So we are actively evaluating life cycle management opportunities.

Thanks, Will. And I would just emphasize that our lifecycle opportunities are focused in the rare space, and we want to continue with the profile that we have with the product. So we're really excited about the things we're exploring right now, and we'll probably be addressing those on future calls. Thank you. Thank you.

Thank you. Next question today is coming from Pavan Patel from Bank of America. Your line is now live.

Hey, guys. Thanks for taking my questions. The first one is on a GAMRI. I believe you mentioned that you've reached nearly all of the DMD centers of excellence. So maybe if you can provide some more color on the depth of prescribing versus breadth, and what feedback are you getting from physicians and payers about the profile, and what do you see as the main hurdle to full conversion in this patient population? And then on FertApps, just the growth is pretty strong on a year-over-year basis. and you reaffirmed your full year guidance for that product rather than raising it. So that sort of implies a sequential slowdown. Just wondering if this reflects conservatism, or are you anticipating that true slowdown in 4Q? And can you elaborate on which growth driver, whether it's new patients, enhanced dosing, or persistence, is contributing the most to your year-over-year growth? Thank you.

Thanks, Bhavan. Yes, for adoption. So I'm sorry, we were just clarifying your second question, and we'll come back to that. Jeff, do you want to handle the first one on centers of excellence in depth and breadth?

Sure. So very good question. And it truly does vary across all the centers of excellence. What's very unique about Duchenne muscular dystrophy is one center of excellence is far different from the next one. So there's not one uniform way that they prescribe steroids. for their boys living with DMD. So we have many of these centers with multiple patients on it, like 10, 20, and in some cases, many more than that, or much more than that. And then we have other centers that only have a handful of patients. So that's what our goal is. We have to look at these as a unique center of excellence. One center, it means that you know one center of excellence. So we have to identify a variety of ways to help provide education on the differentiation for a GAMRI for that center that's pertinent to them. So hopefully that answers your question, but it varies across all top 45 and the top 100. And then as far as the payers, when we look at the payer reception for a GAMRI, I mentioned it on the call, over 85% of the patients are reimbursed and it's much more than that. It's a very strong reception by the payer and the payer landscape. We're very pleased with and we don't anticipate it changing here.

Your second question, we just want to clarify, was about the year-over-year strength And then what are the growth drivers that we anticipate? You mentioned new patients, dosing. I think there was a third one you mentioned as well.

The last one was persistence of patients. Persistence. Okay. Yeah. And then also on the sequential slowdown implied by the guidance, if you can explain that.

Okay. Just to make sure we're talking about Ferdaps, correct? Right. Okay. So, yeah. And what I want to talk about here is, you know, I did mention this, that The growth from FERDAPs will come from multiple segments, both idiopathic limbs as well as the cancer associated limbs. What we're seeing now is the 500 or so patients, the pool of patients that we have that are somewhere in their diagnostic journey for limbs. We are able to help these patients or convert these patients onto treatment appropriately much more quickly. And we're doing that by helping focus our field force our dedicated field force of 16 rams now on the right leads to help these patients get on therapy. So that's one thing. Another thing is we have many initiatives in place to get BGCC antibody testing added to panels. Like an example is myasthenia gravis. So once that's added, we'll also see a growth in the number of patients that are tested and hopefully diagnosed with LENS which we can then focus on and help these patients get on therapy. Another thing is we've identified additional data sources that are providing more LEMS, prospective LEMS patients to us, which will then turn into leads that increase our pool of patients. We also utilize machine learning that helps triangulate claims data So here's a quick example is we've noticed that patients that have a negative ACHR test as well as a positive VGCC, those patients are more likely to get on Ferdapp's treatment and get on treatment sooner. So then we provide those leads to our RAM team to help those patients accelerate their time to get on product. So that's been very beneficial. Couple of other things, a pharmacy intervention program. What we're doing is we noticed that in some cases it takes patients a little longer to titrate than the label to get onto their optimal appropriate optimal dose and our pharmacy outreach and the intervention program. We've seen benefits from that program that have accelerated that time to get on their appropriate optimal maintenance dose more efficiently. So a lot of those things are helping contribute to today's growth, and we are confident we'll continue to provide levers for us to grow in the future. And then in 2026, we expect CA LEMS to contribute more to the growth for LEMS.

Pavan, does that address your question?

Yeah, that addresses the question pretty well. And then I guess just like in terms of like the guidance, why not take it up on for it apps at the product level? Um, given the strength thus far, just what's the rationale behind that? Is that just conservatism or is there something that you expect, uh, in 4Q, whether there was a one-timer in 3Q or something like that?

So we know this product really, really well, um, for seven years it's been on the market. So we're, we're confident in our ability to forecast the product. Jeff, do you want to speak at a high level to the performance of new enrollees in the third quarter, just at a high level?

Sure. New enrollees were actually very strong and much higher than we had forecasted. So it was the highest month that we've had in two years. Yeah.

But those patients, obviously, we don't get a full year from. So we're looking forward to that growth continuing as we go into 2026. So we're seeing very positive trends. We like what we see. We like what we see on the testing growth as well. And there's a touch, I would say, a touch of seasonality in the fourth quarter. So we can look at sequentials or we can look at year over year, but we're confident in our continued growth.

Great. Thank you so much. Super helpful.

Thank you.

Thank you. Next question today is coming from Luke Herman from Robert W. Beggar. Why is it now live?

Hi, guys. Congrats on the quarter, and thanks for the question. First, on the GAMRI, given this week's outcome of confirmatory data from the approved PMOs, which is obviously just really unfortunate for the community, but do you think this can sort of emphasize the importance of an optimal steroid regimen for physicians and patients and their families?

That's a great question. You know, this is a community that's very, very tight. They know, they see everything, and they're really engaged with us and obviously all the companies. When we think about the use of a product like a GAMRI, it's obviously the first product that a patient gets on. It's recommended. It's foundational therapy. And these stories are unfortunate for the community, as we gain further and further strength and momentum in the market, we believe that we can fill the necessary gaps that might be coming out as a result of some of these conversations. Jeff, do you want to speak to what we might have heard so far about some of these issues surrounding the studies? Yeah. Sure.

I mean, I'll stick to the agamory and steroids. I think what Rich was mentioning, too, is that Steroids are the foundation of treatment for MD. And so that we know that having that is the biggest part of this. And regardless of what other products that come out, the steroids will always be the first thing that they will treat their patients with.

And I think our patient advocacy and then patient support really helps us to kind of weather those bumps in the market that don't necessarily affect us directly. And the support that we give to the patients through Catalyst Pathways is really a strong, strong opportunity for the patients to get past some of these situations. So we think we can continue to perform well.

Great. And then I just had one on the financials. In some commentary on payment timing in relation to the cash balance, I think you noted a lower gross than that expense. Is that material for growth tonight going forward, and was that a benefit in 3Q?

Sure. Thanks for the question. It's not insignificant. So, you know, from a materiality perspective, certainly we thought it was noteworthy. And then, sorry, what was the second part of that question?

So is this an impact on a go-forward basis, or did it affect 3Q as well?

It is in Q3 and impacts the future as well. This is a permanent change to our contract terms.

I just want to emphasize that it's a permanent change. We experienced this one-timer mostly because if you think about a shift, we renegotiated a very, very important, very large contract with a buyer, and they used to pay twice a month. Now they only pay once a month. So we received their payment October 1st.

October 2nd, we received approximately $24.9 million. That, under the old terms, would have been by September 30th.

So for this issue specifically, because you're asking about it, we don't expect this one to repeat. That's right. Yeah. So this is a one-timer, and that's why we called it out in the queue. We wanted to be sure that we were clear about how it might affect Q3, but we expect the customer to continue to pay once a month, and we think that's accommodated for or will be accommodated for on a go-forward basis.

All right. Thank you.

Thank you. Thank you. Thank you. Next question today is coming from Sudan. Logan from Steven's anchor line is now live.

Hey, uh, good morning catalyst team. This is a key salve on for Sudan. Um, congrats on the great quarter. Uh, my first question is just like, um, you know, roughly with the, the 17% off the whack when TVA came in, what's the expected discount on Phi Kappa after more tablet and, Suspension generics enter later this year and how does that discount curve look and then my second one is kind of just on third apps With hetero move into trial slated for March 2026 What was the general sentiment during the the Markman hearing considering that TV and Lupin kind of decided to settle?

Thank you Thanks So on the first part of the first question, what we see is a mixed shift, as you would expect. So when a generic enters the market, especially one that's so heavily influenced here by Medicaid, we're not affected in the Medicaid on our volume basis. So we have not given price, but as we forecasted, we would lose volume. And then there's a mixed shift. So there's, as a percentage, a higher percentage of Medicaid, a lower percentage of commercial. And so that's what causes the price to go down. So The volume changes, and it shifts, and then we have an impact on price. So does that answer your question?

Yeah, it does. Thank you.

Okay. Great. Now, your second question about hetero and where we stand, I'm going to turn it over to Steve Miller. Steve?

Thank you. With regard to the market hearing, it was relatively routine. There was a number of items that were simply pushed off to the trial. You said simply that's a matter for trial. There was no outcomes that dramatically changed the view of the enforceability of the patents for either side and the strength of their cases. We continue to remain confident that our intellectual property is strong and we're going to vigorously defend it. I also want to point out that like all the litigants of the past, we continue to have discussions with all of them, including Hetero and if this last litigant has something to say that we think is in the best interest of the shareholders.

Thank you. Thank you. Thank you. We reach the end of our question and answer session. I'd like to turn the floor back over for your further closing comments.

We're really appreciative of the support that we've received from the market, and we're really appreciative of the work that our employees have done in support of patients. And thank you again for your participation in the call today. Thank you. That does conclude today's teleconference and webcast.

You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.