Catalyst Pharmaceuticals, Inc.

Greetings and welcome to the Catalyst Pharmaceuticals fourth quarter and full year 2024 financial results conference call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Cowan. Thank you, and you may begin.

Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's fourth quarter and full year 2024 financial results and business highlights. Leading the call today is Richard Daley, Catalyst's President and Chief Executive Officer. We're also joined by Jeff Del Carmen, our Chief Commercial Officer. Further, for the Q&A session, Dr. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer, and Dr. Gary Ingenito, our Chief Medical and Regulatory 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 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 2024 Annual Report on Form 10-K. At this time, I'll turn the call over to Rich. Thanks, Mike.

Good morning, everyone, and thank you for joining us today. 2024 was an exceptional year marked by record revenue growth and a strong fourth quarter that showcased our scalability and financial strength, reinforcing the success of our strategy. For the full year 2024, total revenues grew by 23.5% year-over-year to $491.7 million, exceeding the upper end of our previous guidance and highlighting our ability to capitalize on market opportunities while maintaining operational excellence. Full year net product revenue for 2024 reached $489.3 million, an exceptional 23.4% increase over 2023, fueled in part by our continued successful launch of Agamri, which began on March 13, 2024. In Q4 2024, total revenues and net product revenues reached a record $141.8 million, an increase of 28.3% and 30% over Q4 2023, respectively. The increase was driven by the continued organic growth of FirdApps, steady contributions of FICOMPA, and new revenue from Agamri, which accounted for a portion of the year-over-year increase. Looking ahead, we expect this momentum to continue with 2025 total revenue forecasted to be between $545 million and $565 million. We ended the year with a robust cash position of $517.6 million and no debt, providing an enhanced capacity to invest in strategic growth opportunities. Catalyst's competitive advantage is built on the commitment of our outstanding team and the strength of our patient engagement services, such as Catalyst Pathways. Additionally, our strong relationship with healthcare and rare disease communities drives meaningful stakeholder engagement. Together, our holistic approach enables the patients we serve to streamline access, identify appropriate therapy, receive timely treatment, and remain compliant with their care. Ferdaps' sustained momentum reflects the strength of this approach, delivering 14 consecutive quarters of 15% or more growth year over year. As the only evidence-based treatment for LEMS in the U.S., we believe that Ferdaps is well-positioned to maintain this trajectory for the foreseeable future. Given the incredible benefits Ferdaps offers to patients and the opportunity for continued growth, we remain committed to building this therapy. Jeff will discuss this in greater detail later in the call. In January 2025, we secured a favorable resolution to the TEVA patent litigation, prohibiting TEVA's generic entry until February 2035, absent other occurrences, and reinforcing FRDAP's intellectual property strength. The litigation between the remaining two generic first filers is ongoing, and we remain fully committed to doing everything we can to protect the long-term value of our franchise. Turning to Agamri. Since its launch in March 2024, Agamri has gained significant traction, securing share from both branded and generic sides of the market. This is a true testament to the market's recognition of Agamri's potential differentiation. We've had great success and broad acceptance in many DMV centers of excellence, and we now turn our efforts to going deeper into the COEs to help more patients experience the potential benefits of this unique steroid. As Agamri enters its second year, we expect the adoption momentum to evolve to a sustained growth trajectory, reinforcing confidence in the long-term growth potential. The summit study is up and running, Enrolling Patients. This is a key long-term initiative to provide insight into Agamri's unique therapeutic profile and strengthen its market position. This five-year open-label study aims to provide real-world data versus historic control on the potential long-term benefits of a gamma, including improvements in behavior, stature, bone health, and cardiovascular health. We look forward to working with the participating centers on enrollment and future data analyses. Phi Kappa has established strong patient preference due to its proven efficacy and benefits in seizure control. We are proactively implementing targeted strategies to manage FICOMPA's lifecycle ahead of its expected patent expiry in May of 2025. We anticipate a gradual revenue decline in the second half of 2025 as physicians and patients prioritize clinical civility with a continued decline in 2026 and beyond as payer-driven transitions accelerate. Jeff will provide an overview of our commercial performance, followed by Mike's financial update later in the call. As we execute our strategic priorities, our buy and build approach remains a core pillar of our long-term growth, driven by disciplined business development. We are actively evaluating several accretive and near-accretive rare disease opportunities, prioritizing strong clinical differentiation and a clear commercialization potential. While we have not yet found the right opportunity, we continue to make significant progress on this front, leveraging our rigorous due diligence process in an effort to secure the right assets at the right time to drive sustainable success. Our international strategy has two core elements. First, we are building a sustainable network of out-licensing partners with whom we can rapidly transact in the future, a plug and play strategy. Second, as with our approach in the U.S., we seek markets where our products can make a difference, ones in which our products would represent a differentiated offering, enhance access to care, and improve health equity. In January 2025, our sub-licensee, Dido Pharma, successfully launched FirdEPS in Japan, expanding access for LEMS patients in this key market. Meanwhile, CHI Pharmaceuticals, our licensee in Canada, remains on track to submit a new drug submission for GAMRI to Health Canada in early 2025. As part of our strategic focus, we remain vigilant in navigating market and regulatory challenges, including evolving healthcare policies and a shifting competitive landscape. By staying agile and adapting to industry changes, we are well positioned to manage risks and drive growth. Leveraging our rare disease expertise and operational excellence, we believe that we are well positioned to drive sustained growth and capitalize on emerging opportunities for long-term value. Now, I'd like to turn the call over to Jeff DelCarmen, our Chief Commercial Officer. Jeff?

Thanks, Rich, and good morning, everyone. We are thrilled with our exceptional performance in 2024, marked by full-year net product revenue of $489.3 million and total revenues of $491.7 million. surpassing the upper end of our 2024 full-year total revenue guidance of $475 to $485 million. This outstanding achievement was driven by Ferdaps' full-year revenue, reaching a record high of $306 million, the successful U.S. commercial launch of Agamri, and the continued strong contribution from FICOMPA. Let's start by reviewing our advancements with Ferdaps. the only evidence-based FDA-approved treatment for Lambert-Eaton myasthenic syndrome. In the fourth quarter, net product revenue amounted to $82.5 million, showcasing a remarkable 18.3% year-over-year growth. Furthermore, Ferdaps' net product revenue for 2024 showed strong 18% growth year-over-year, driven by a steady influx of new patient initiations and a low annual discontinuation rate of under 15 percent, exceeding internal expectations. Prescription approval rates exceeded 90 percent for all types of payers, including government and private commercial insurers. Patients enrolled in Catalyst pathways, including those with Medicare coverage accessing third-party foundation assistance, experienced an average monthly copay of less than $2. Now I'd like to turn to Agamri. We are proud of Agamri's successful commercial launch and its growing recognition as a breakthrough treatment for Duchenne muscular dystrophy. Full year 2024 net product revenue reached 46 million, surpassing the revised guidance of 40 million to 45 million. In Q4, 2024, Agamri delivered strong net sales of 21.1 million, driven by increasing adoption. Adoption has been robust, with 93% of the top 45 DMD centers of excellence and 209 unique healthcare providers submitting enrollments for Agamri. We continue to see strong transitions from both corticosteroid segments with 44% coming from Prednisone and 43% coming from Enflaza. Additionally, 85% of shipments were reimbursed with an average approval time of approximately nine business days after we received a completed enrollment form. We anticipate further reductions in approval time as payers finalize their policies in the coming months. Lastly, I would like to provide a brief overview of FICOMPA. For the fourth quarter of 2024, FICOMPA delivered strong results supported by steady demand that reinforced its market position. Q4 2024 net product revenue of $38.2 million further strengthened our revenue diversification. FICOMPA's full-year 2024 net product revenue reached $137.3 million, surpassing our guidance range of $130 million to $135 million. To enhance our focus on the markets for FERDAPs and the GAMRI, we have made a strategic decision to divide our commercial field-based team into two dedicated units. The FERDAPs field force will consist of 16 regional account managers. while the Agamri field force will include 12 regional account managers. We anticipate implementing this focused approach by early Q2 with most of the additional headcount filled by internal personnel. We are confident that FERDAPS's organic growth in 2025 will exceed 15%, driven by several key factors. the continued conversion of a portion of the 500-plus identified LEMS patients to FERDEP's treatment will be a significant contributor. Additionally, the approval of the expanded 100-milligram label in June 2024 enables patients to access a higher daily dose when appropriate, further supporting growth. Furthermore, we are well positioned to capitalize on the cancer-associated LEMS opportunity by shifting our focus toward community-based oncology physicians, who we estimate treat approximately 85% of all cancer patients. We expect that this strategic pivot will allow us to more effectively target the approximately 90% of small cell lung cancer LEMS patients who remain undiagnosed. Our efforts will center on implementing BGCC antibody screening programs with major GPOs, accelerating LEMS diagnosis rates. In 2025, the dedicated field force will create deeper adoption of a GAMRI in the approximately 100 DMD COEs, allowing for continued growth following the initial surge of early adopters. The crowded DMD landscape has created a competition for share of voice within these institutions. In addition, we believe there is a cueing effect for patients as they are evaluated for treatment of new therapies, delaying initiation of Agamri for some patients. However, we remain confident that our dedicated Agamri field force will continue to expand Agamri's adoption across both prednisone and influenza segments. Finally, as we mentioned by Compalooza's exclusivity in May 2025, we will continue to leverage personal promotion through LOE due to the promotional sensitivity with anti-seizure medications. In summary, our exceptional performance in 2024 reflects the strength of our product portfolio and our ability to meet the needs of diverse patient populations. Strategic investments in marketing, education, and patient support have been pivotal to this success, and we are committed to building on this momentum. We look forward to driving sustained commercial execution and making a meaningful impact on the patient communities we serve. I express sincere appreciation to the entire Catalyst team for their unwavering dedication to patients. I eagerly look forward to a prosperous year ahead. I will now turn the call back over to Mike.

Thank you, Jeff. As Rich and Jeff mentioned, Catalyst's fourth quarter and full year 2024 financial performance resulted in another record-breaking year, driven by exceptional execution by all facets of our business. In addition to our outstanding results, I would like to highlight the incredible work done by the Catalyst team with the commercial launch of Agamri in March of 2024. Now on to 2024 results. Our total revenues for 2024 were $491.7 million, a 23.5% increase when compared to total revenues of $398.2 million for 2023. Product revenue net for 2024 from our lead product, FirdApps, was $306 million, an 18.4% increase year over year compared to $258.4 million for 2023. Product revenue net for GAMRI was $46 million for the period from the commercial launch on March 13th, 2024 through year end. Product revenue net for FICOMPA was $137.3 million compared to $138.1 million for 2023. As mentioned previously, 2024 FICOMPA net product revenue was adversely affected by gross-to-net changes compared to 2023 when our gross-to-net for FICOMPA was booked under a size more favorable arrangements with distributors and government agencies. Starting in 2024, all such costs have been tied to arrangements between us and those distributors and government agencies. Since our costs under these arrangements are higher than the size costs, we were impacted by an increase in gross-to-net deductions for phycompa therapy, causing a corresponding decrease in phycompa net product revenue. During 2024, we recognized approximately $2.4 million in license and other revenue, which consisted primarily of a $2.1 million milestone payment earned upon Dido receiving product approval to commercialize Ferdaps for the treatment of patients with LEMS in Japan. 2023 license and other revenue was approximately $1.7 million, which included a $1.4 million milestone earned as a result of Datto submitting a Japan NDA for FerdApps to the Pharmaceutical and Medical Devices Agency in Japan. For 2025, we are forecasting FerdApps net product revenue to be between $355 million and $360 million. which also reflects an increase in the U.S. gross-to-net driven by the Inflation Reduction Act, or IRA, impact on our Medicare Part D for that sales. We expect that the IRA impact will continue to increase annually. We are forecasting a GAMRI 2025 in net product revenue to be between $100 and $110 million, and we are forecasting FICOMPA 2025 net product revenue to be between $90 and $95 million. In 2025, FICOMPA net product revenue will be impacted by the loss of exclusivity and the anticipated generic entrance into the FICOMPA market. Finally, based on Dido's commercialization of FerdApps in Japan, we expect to record some revenue which is included in the FerdApps guidance based on the sale of FerdApps to Dido in lieu of receiving royalties. While we do not expect our 2025 revenue from sales to data to be material, we believe that our global expansion to make our product available to LEMS patients and other jurisdictions to be an important element of our business plan. We reported US GAAP net income for 2024 of $163.9 million, or $1.38 per basic and $1.31 per diluted share. an increase of 130 percent year-over-year compared to GAAP net income for 2023 of $71.4 million, or $0.67 per basic and $0.63 per diluted share. The increase in net income year-over-year is attributable to growth in FERDAPS' net product revenue and the addition of net product revenue resulting from the launch of the GAMRI. Additionally, in 2023, we recorded the one-time Montgomery-related $81.5 million acquisition-related IP R&D expense. Non-GAAP net income for 2024 was $276.3 million, or $2.33 per basic and $2.21 per diluted share, which excludes the income tax provision of $52.4 million, amortization of intangible assets related to our acquisitions of Resurgy, FICOMP, and GAMRI of $37.4 million, stock-based compensation expense of $22.3 million, and depreciation of $397,000 from GAAP net income. This compares to non-GAAP net income for 2023 of $141.6 million, or $1.33 per basic, and $1.25 per diluted share, which excludes the income tax provision of $23.1 million, amortization of intangible assets of $32.6 million, stock-based compensation expense of $14.3 million, and depreciation of $316,000 from GAAP net income. These non-GAAP results represent an approximate 95% increase of non-GAAP net income year over year. As a reminder, in Q3 2023, we acquired Agamri Commercial Rights in advance of U.S. FDA approval, which required that the company expense the acquired IPR&D at the time of the acquisition. Our cost of sales in 2024 was approximately $68.8 million, compared to $52 million in 2023, and consisted principally of royalties. GAMRI royalties paid to the product licensor increase based on different net sales criteria. For 2025, we expect the GAMRI royalties to increase as a percentage of net sales compared to 2024 based on our net product revenue guidance of $100 to $110 million. The company is also required to make a $12.5 million milestone payment to our product licensor once the GAMRI's net product revenue in a calendar year reaches $100 million. Further, we are required to pay royalties based on net product revenue to the product licensor for FICOMPA following the loss of exclusivity which will occur in May 2025 for the tablets and in November 2025 for the oral suspension. The royalty rates are higher if there is no generic entry following loss of patent exclusivity than they are once generics enter the market. Research and development expenses were $12.6 million in 2024 compared to $93.2 million in 2023. As previously mentioned, the driver behind the decrease in research and development expenses relates to a one-time agamory IP R&D expense of approximately $81.5 million during the third quarter of 2023. Relative to the normal course of business, absent another acquisition, we are forecasting research and development costs in 2025 to be between $15 million and $20 million. We anticipate that our R&D expenses in future years may become more significant if we seek to execute on the development of additional indications for FERDAPs and a GAMRI, or if we acquire additional products still in development. SG&A expenses for 2024 totaled $177.7 million, compared to $133.7 million in 2023. The increase in SG&A year over year is principally due to expenses related to a GAMRI. including commercial support expenses, selling and marketing expenses, and an increase in corporate headcount required to support the expanding company infrastructure. We anticipate 2025 SG&A expenses to increase compared to 2024, primarily driven by increased headcount, including full year costs for individuals hired throughout 2024 in certain functional areas to support the growth of our business and our overall strategy, as we focus on expanding our product portfolio, and the launch of separate commercial and medical field forces for Ferdaps and Agamri, which is scheduled to commence at the beginning of the second quarter. Our effective tax rate for 2024 was 24.2% compared to 24.4% for 2023. 2024, the difference to the statutory federal income tax rate of 21% was primarily driven by state income taxes and anticipated annual permanent differences. We anticipate that our effective tax rate for 2025 will be relatively consistent with our 2024 and 2023 tax rates. It is important to note that our tax rate is affected by many factors, including the number of stock options exercised, State tax rates impacting our business and other items in any given period and is likely to fluctuate in future periods. I would like to emphasize that this is an annualized effective tax rate, which is not directly correlated to quarterly net income before income taxes and may be higher or lower on a quarter to quarter basis, depending on how the company is trending against annualized net income before income taxes. As we reported, we ended 2024 with cash and cash equivalents of $517.6 million, compared to $137.6 million at December 31st, 2023. The increase in cash of approximately $380 million was largely driven by approximately $240 million in cash provided by operating activities, as well as approximately $141 million raised in the January 2024 capital raise. We believe that our current funds continue to allow us the financial flexibility to fund our existing R&D activities, 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 full year 2024 financial performance may be found in our annual report on Form 10-K which was filed with the Securities and Exchange Commission yesterday, February 26th, 2025, and can be found on the investor relations page of our website at www.catalystpharma.com. And with that, I will turn the call back over to Rich.

As we embark on 2025, we are energized by the opportunities ahead and remain focused on delivering meaningful advancements for patients with rare diseases. Our passion, expertise, and unwavering commitment will continue to drive us forward as we execute our strategic priorities and expand our impact. I want to extend my gratitude to our employees, partners, and stakeholders for their dedication and support. Your contributions are instrumental in our success, and I look forward to what we will accomplish together in a year ahead. I'd like to turn the call back to the operator. Thank you.

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star key. One moment, please, while we pose for questions. Our first question comes from the line of Charles Duncan with Cantor Fitzgerald. Please proceed with your questions.

Thank you. Morning, Rich and team. Congrats on a great year of progress. And thanks for taking our question. I had a question about FERDAPs and really the guidance. I'm wondering if Jeff can provide a little bit more color on the new patient ads as well as the low discontinuation rate that you're seeing. And then with regard to guidance for FURDAPs, it's fairly narrow, 355 to 360 versus, for example, a GAMRI, which is broader. And I'm kind of wondering why you have so much precision on the guidance at this stage with regard to FURDAPs. Thanks.

Thanks for the question. Obviously, you know, we have a lot more experience with with bird apps. And I think Jeff, I'll turn the call over to Jeff, but the pool of patients that we have, and the continued confidence that we have in the brand and the uptake, I think, Jeff, to that more, more clearly than I can.

So Jeff, thanks, Rich. And good morning, Charles. As we've mentioned, we have over the 500 plus pipeline leads. And those are those patients that are diagnosed with LEMS, but not yet on FERDAPs. Those patients typically contribute about 50% to our new enrollments each month or any given quarter. So we have a good handle on that, what we have in front of us, and when we can help those patients transition onto therapy. So that gives us confidence in that sense. Also, the discontinuation rate has been very steady since we launched this back in 2019. And actually in 2024 full year, the annual discontinuation rate was 15%. So that was very strong. So we're very confident about that. And as Rich mentioned, our experience with this product and what we've seen, it's what you see typically with rare disease products in this sense, is that you have a For a while, you get a steady state of enrollments. You know how many enrollments you're going to get every given month. So that allows us and gives us confidence as to how we project or forecast 2025. Is that helpful, Charles?

Yeah, it is helpful. And I had just one follow-up. And this is more of a strategy question with regard to the deployment of cash. You're building cash nicely in the last year. And I guess I'm thinking about Phycompa and perhaps revenue being reduced in 26. Is it your plan to try to replace that revenue with another effort in epilepsy, or are you not so concerned about epilepsy specifically and investing further in that? But what would you like to do in terms of the Phycompa revs in 26? Thanks.

So from a business development standpoint, we remain open to orphan and differentiated products that we think can make a difference for patients. If it's epilepsy, we stand behind the Phi Kappa acquisition as something that helped us build our war chest, if you will. But we want to stay in the orphan space. Retail is not a place we want to spend a lot more time in the future. If it's epilepsy and it's orphan, we would be interested in that. But we have a very wide aperture for acquisitions or partnerships for products. That's helpful.

Thank you.

Thank you.

Thank you. Our next question comes from the line of Jason Gerberry with Bank of America. Please proceed with your question.

Hey, guys. This is Bobbin on for Jason. Congrats on the quarter. First question, I wanted to ask you guys what the new indication that you're pursuing with the GAMRI is, which we noted on the PR. And then the second question may be on M&A. Is the company looking at gene therapy, which has proven challenging for others in biopharma? And just wanted to get your thoughts on continued efforts towards revenue diversification. Thank you.

Thanks for the question. Regarding the new indications, so in the 10-K, we did speak to some of the work that we're doing to further classify how we might go forward with a GAMRI. I'll turn that over to Gary, our chief medical officer. Gary, do you want to address the work that we're doing there?

Sure. Thank you. Yes, you know, of course, our focus has been on the successful launch of Agamri, and we continue to look at rare diseases which can benefit from a unique corticosteroid in that. And in terms of that, we're further characterizing Agamri in terms of its ability to provide immunosuppression and look at the characteristics of the product. that will allow us to better assess it for all the potential possibilities in the rare disease space.

And to your question about gene therapy, obviously when we look at the opportunity within the orphan space, we see the vast majority of orphan conditions have a gene component. So this is something we track very, very closely. We think about it. in very similar ways that we think about our other opportunities, non-gene therapy opportunities. However, we look at it with a little bit, maybe a little bit more closely in a couple of components. Obviously, the opportunity has to be close to market. It has to be immediately accretive or nearly immediately accretive. The CMC has to be very, very clean because we think this is incredibly challenging. I think you all know I come from a cell therapy background, obviously different from gene, closely aligned on the CMC component. So we look at that and we really want to be sure that we truly understand the CMC component of it. And there has to be a clear need. We've seen the uptake of gene therapy products be incredibly challenged. So we really want to understand the differentiated nature of the product for the therapy. and we want to understand what's going on in the market space. So we would consider it. However, we want to be really careful in understanding how the product might perform given the performance of past gene therapy products. Is that helpful?

Yep, that was great. Thank you, guys. I really appreciate the help. Sure.

Thank you. Our next question comes from the line of June Lee with Truett Securities. Please proceed with your question.

Congrats on the quarter, and thanks for taking the questions. This is Asim Ranul on for June Lee. Just a question on the gross net. So you mentioned a gross net change for Ferdows in 2025. How much of a change should we expect from 24? And then what proportion of Ferdows patients are currently on the 100 milligram dose? Thank you.

Thanks. First question, we'll turn it over to Mike, and then the second question we'll turn it over to Jeff. Mike, do you want to take that one?

Sure. Thanks, Rich. 2024, we saw a very small impact from the IRA. Less than 1%, if you look at the gross net. We're thinking that based on the book of business, that could be in the 3% to 3.5% range for 2025.

And we'll continue to increase. As a reminder, we're under the small manufacturer, so there's a phased-in approach.

Over years, right?

Over the coming years, yes. And I'll answer the question about the dosing. What I can give you right now is our average daily dose has increased. We saw since the label expansion in June, the average daily dose increased about two milligrams. And we have forecasted for 2025, because of the increased availability or flexibility to physicians to optimize treatment for these patients, an additional two milligrams built into the forecast for that. At this time also, there are about 20% of our patients that are at about 100 milligrams.

Thank you.

Thanks. Thank you. Our next question comes from the line of Samantha Simcoe with Citi. Please proceed with your question.

Hello. This is Benjamin Pellucci on for Sam. Thanks for taking our questions. Maybe starting with the GAMRI, can you speak to the factors that you expect to drive demand for in 2025 and that support your 2025 guidance of 100 to 110 million? How should we think about the cadence of the launch throughout the year?

Thanks, Benjamin. I'll turn it over to Jeff for the demand question.

Thanks for the question. And regarding Agamri, we mentioned the percent mix of the transition, so the boys living with DMD, 44% coming from the prednisone segment and about 43% coming from Enflaza. And that gives us extreme confidence in the continued growth because we're seeing transitions across both segments. Initially, when we launched, we expected more of our transitions to come from Enflaza for a variety of reasons. So having that, again, gives us confidence. We continue to expect transitions from both segments moving forward at a steady pace. I did mention the competitive landscape that we're seeing. So what we expect is over time, over this year, we'll see some of that effect of the queuing effect that I mentioned will be playing itself through, so probably in the middle of the year, and we'll start seeing more acceleration in enrollments, which is built into the forecast that we provided. Does that help at all?

Yeah, that's helpful. Thank you so much. And then maybe moving over to deferred apps. Can you speak to your expectations for revenue contribution from small cell lung cancer patients over 2025? How much growth are you expecting from this segment over the next several quarters? Yeah, Jeff will take that one as well.

At this time, we see about 20% of our revenue or our patients are from the small cell lung cancer lens or cancer associated lens segment. And we expect in 25 to really focus on initiating or getting screening programs implemented. So it's really about helping those 90% of undiagnosed small cell lung cancer lens patients get diagnosed. So that's where our focus. So as far as contributions this year or growth from the small cell lung cancer lens segment, it's going to be very minimal in 2025, but we expect that to grow in out years.

Yes, I'll just add to that. We've had a really thoughtful approach here in developing the KOL community around this in academic institutions. Jeff and the team have done a really, really good job making sure we work closely with the KOLs to get the opportunity for understanding of how this would work. And now pivoting that effort now to the community where, as Jeff said, the vast majority of small cell lung cancer is treated. The KOLs are in position. I think our messaging is in position, and so we could pivot now and begin to work with those physicians in the community. So we're really excited about this opportunity.

Great. Thank you so much.

Thanks. Thank you. Our next question comes from the line of Joe with Piper Sandler. Please proceed with your question.

Great. Hey, everybody. Thanks for taking my questions. Maybe first one, following up on those recent comments you made, Jeff, on the cueing effect you're seeing in DMD. I'm wondering if you could elaborate a little bit more on what you mean by the cueing effect and anything you guys can do to shorten the time a patient spends in that cue and maybe somewhat relatedly what you've seen or heard that has sort of led you to make the decision to separate the Salesforce I prefer DAPS than a GAMRI later this year. Thanks, and I have maybe a quick follow-up.

Sure. Thanks for the question. And, you know, first thing is a competitive landscape within the Duchenne space is a great thing for the patients, and we want to acknowledge that. In June of last year, Alevitas, as you know, had an expansion of their label, so that allowed for boys four years of age and older regardless of ambulatory status, to be eligible or considered for a Levitas treatment. When that happened, a lot of patients and their families and the healthcare providers wanted to see if they could be evaluated or are they a fit for a Levitas treatment. So this is just an example. So when that happens, these patients in this treatment team, they do not want to change their treatment. their steroid if they're on prednisone. They stay on prednisone until they're evaluated and either treated or decided that it's not the right fit for them. If they are treated, then typically what they'll do is they'll wait about 60 days post-alevitis treatment before they will consider switching their steroid. So it's that type of cueing effect. It's not just those patients that are on a new product. It's as they're being evaluated for treatment on any of these new products. So that's why it may delay, just delay, the initiation of a GAMRI. But this happened in June, and we've seen it playing through, and we expect it to work its way through probably by the middle of this year. So we don't anticipate this being a long-term challenge for a GAMRI. We just see it as a slight delay for initiation to a GAMRI for some patients.

Is that helpful, Jeff?

Yeah, that's helpful.

Maybe my follow-up on phycompa, I know historically you guys have said that the epilepsy market could be resilient to generics. Wondering if your guidance for 2025 factors some of that resiliency in. And I think you alluded to this a little bit, but any new efforts that you'll employ to maybe slow that erosion trajectory? Thanks.

So, we see the resiliency there. Obviously, we have the opportunity to sell the product under the patent through the end of May, the solid dose, and then the suspension through the end of November. So, we're excited about that, and we'll continue to make those efforts. The resiliency is there in the fact that there's that stickiness that we continually talk about. However, once the generics come on the market, we will see price erosion and volume erosion. So we expect to have that opportunity to continue to work with the payers, and we are working with the payers right now to continue to get favorable position in the marketplace and hold it. We do expect the patients to want the brand, a significant portion of them want the brand, and the payers to want to work with us to hold that favorable position. Unlike traditional products, traditional retail products that lose the majority of their volume in eight weeks post-patent expiry, we expect to hold on to a considerable amount of our volume throughout the year.

Great, and I wanted to respond. I forgot to, Joe, I forgot to respond to your message about splitting up the sales force. So what we're doing by having a dedicated sales force, it's allowing us more of a focused approach. I mentioned earlier the really crowded competitive landscape for Duchenne specifically. And when you look at that, a dedicated sales force for a GAMRI will allow us to optimize engagement with the treating HCP team, so that team across any center of excellence, and support the continued growth. So that's why we made that decision. Now, also, for FERDAPs, when you evaluate the LEMS opportunity with FERDAPs, we've talked about this. We see significant opportunity for organic growth into the future. And by allowing this dedicated or specialized approach for a GAMRI or for FERDAPs, also, that will allow us for those deeper relationships to help find these patients and help these patients get diagnosed and transition to treatment.

Great. Thank you. Appreciate you circling back on that. Thanks for taking my question.

Thanks, Joe. Thank you. Our next question comes from the line of Joel Beattie with Bayer. Please proceed with your question.

Hi. Thanks for taking the question. The first one is related to a gamma ray. In the competitive DMD marketplace, what are you seeing in terms of generic erosion for EMPLASA, and how much could that impact the opportunity for a gamma-ray to grow?

Thanks for your question. We have not seen much generic conversion from and branded EMPLASA at this point, from what we've seen. We haven't seen much, and we don't see that impacting a GAMRI, and we have not really factored that into or made assumptions based on that into our forecast for a GAMRI in 2025. We haven't seen any changes to payers and how they've reacted to a GAMRI because of generic implausa, so that's what gives us confidence that we'll have minimal impact to a GAMRI in 2025.

So, Joel, remember, Inflaza has been on market for a couple of years. Patients, if they are doing step therapy, they've tried prednisone, they've tried branded inflaza, making them step back through a generic inflaza, not likely to happen. So right now and for the foreseeable future with the steadiness of the patient population, it's not likely to happen, not likely to have a large effect on the ability to take that patient who's already been on prednisone or a version of inflaza, it's just not likely to happen. at this time and again for the foreseeable future. Does that make sense?

Yeah, that does make sense. Thank you. And then maybe one last question related to SG&A in 2025. In the prepared remarks, you mentioned an increase this coming year. Could you quantify that at all?

No, thanks. We haven't quantified. If you recall, we did not quantify last year either. We are expecting the increase as we laid out, and we'll give a little bit more clarity as the year progresses. In part, you know, how long does it take to fill up the positions, et cetera.

Thanks, Josh. Thank you.

Thank you.

Thank you. Our next question comes from the line of Levin Dershowitz with Oppenheimer. Please proceed with your question.

Hey, Leland. Hey, this is Rowan on for Leland. Thanks for the question. How you doing? Good, how are you? Just a couple questions for me. Now that we have greater clarity on the Firdapps IP protections moving forward, how does that shape further investment into the franchise? And also, how do you think about the extended commercial runway and how it changes the approach to business development when evaluating different size and structure deals.

Great question. Thank you for the questions. So remember, there are still two other litigants out there, right? So we're still working to defend the entire estate, and we want to be sure that we're doing that. But the question's a really good one. As we look at the opportunity, should we end up with a full 10-year opportunity we would look at it as if it's a brand that's going to be on the market for 10 years, and you would continue to look and seek opportunities to invest. And as we talked about with an earlier question, you can see us working a bit more aggressively on the oncology side, because if there's an opportunity to build that part of the business, which is about 50% of the business, we would continue to do that. We may go back and look at some other research opportunities as well. There may be opportunities there. We have to fully vet those opportunities as well. But we'll continue to look at the opportunities and see if there's a way to continue to build a business. Life cycle management has many forms. It could be through research or development of a product, I should say. or it could be through further commercialization efforts as well. So we're going to consider all avenues to fully optimize the value of the asset.

Got it. And we saw that the guidance for FICOMPA reflects some expectations of possible generic erosion. I mean, patients in this space tend to see greater brand adherence than in others. And can you speak to maybe what you're seeing commercially that is driving the lower guidance

So what will happen, so we'll drive the lower guidance, is we'll be able to maintain the trend that we're on. The product is, my standard comment is it's like the mailman. It delivers. It just keeps delivering. It'll deliver through the end of May. Should a generic come on the market in June, it'll be fine. But once it goes off patent, some patients are price sensitive. That's the nature of patients. Some patients are brand sensitive. They'll want to maintain, and that's especially true in the epilepsy market. There will be some contracting we'll do with payers to maintain our position. That will be an erosion of price. And we will lose some volume. So there will be a mix of price and volume. But as I said in response to an earlier question, it will be much more sustainable than you would see with a typical retail product. That is the nature of epilepsy products. So that's our expectation at this point in time, and we will continue to give updated guidance as the market evolves.

Thank you. Congrats on another great quarter. Oh, thanks.

Thank you.

Thank you. Our next question comes from the line of Sudan Logan Undone with Steven. Please proceed with your question.

Congrats on the call. This is Felix. I'm from for Sudan Logan Undone. I have two questions, one on FedEx. Given the fact that the product has done very well in the marketplace, how well have you penetrated the LEMS market? If you can give color on the percent, that would be very helpful. And then one other question is on the summit trial for Agyemure. If you can give us potential labor expansion opportunities that you can put out there. That would be helpful for us to model the company very well. So the second part of the question was Summit?

Was it Summit? Okay. Yes. So in January at J.P. Morgan, we gave a market valuation for LEMS at over, and this is, I just want to be really clear, this is at today's prices. today's prices, and a conservative view of the market, assuming there are 3,600 patients in the market, and the addressable size of the market, not the total 100% of the market. Addressable patients within the market. The market is valued at over a billion dollars. The LEMS market is valued at over a billion dollars. So to just give a very simple answer, what's our market penetration? Last year we sold $306 million, so our market penetration would be about 30%. We believe there's tremendous upside in this market. And given the settlement with Teva, should we prevail in the other two suits, we have a runway, prevail in a similar way with the other two suits, we have a runway of 10 years and we're all alone. So, we think there's tremendous upside in this market. And we intend to invest appropriately to see that upside come to fruition. On Summit, We intend to use the summit study to see if we can make it clarify the differentiation of the gamary from other steroids in the market. We believe it's a unique steroid, and we will invest appropriately in that study. Whether or not that can result in a label change, I'll let Gary address that. But there's obviously opportunities to publish, whether it's through posters or publications in journals or not. But Gary, do you want to take the question?

Sure, thank you. As Rich said, we really are looking to get the long-term safety information that we expect to generate with Summit out into the public. The fastest way to do that is through posters, presentations, abstracts, publications, Label expansion depends upon the overall strength and amount of data. We certainly have planned and look forward to the study having that potential the way it is designed, but will depend upon what we see as we go along. However, I believe that the information to be generated on the different parameters of bone health, growth velocity, cardiac safety, fractures, cataract formation, will all be very important data to make available as soon as it is ready to the prescribing population.

Thank you.

Thank you very much.

Thank you.

Thank you. We have reached the end of the question and answer session, and this also concludes today's conference. You may disconnect your lines at this time. We do thank you for your participation.