Catalyst Pharmaceuticals, Inc. Price & Performance (CPRX)

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 President and Chief Executive Officer. We are also joined by Jeff Del Carmen, our Chief Commercial Officer.

Further, the Q and A session, Doctor. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer Doctor. 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 and 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. [indiscernible] 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 ks. 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 $491,700,000 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 hundred and $89,300,000 an exceptional 23.4% increase over 2023. Fueled in part by our continued successful launch of AGAMRI, which began on 03/13/2024, In Q4 twenty twenty four, total revenues and net product revenues reached a record $141,800,000 an increase of 28.330% Over Q4 twenty twenty three respectively, The increase was driven by the continued organic growth of Firdapse steady contributions of FICampA 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 $545,000,000 and $565,000,000 We ended the year with a robust cash position of $517,600,000 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 community drives meaningful stakeholder engagement Together, our holistic approach enables the patients we serve to streamline access, identify appropriate therapy receives timely treatment and remain compliant with their care.

Firdapse's sustained momentum reflects strength of this approach delivering 14 consecutive quarters of As the only evidence based treatment for LEMS in The U. S, we believe that Firdapse is well positioned to maintain this trajectory for the foreseeable future. Given the incredible benefits Firdapse 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 reinforcing Firdapse's intellectual property strength, The litigation between the remaining two generic first filers is ongoing and we remain fully committed 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 differentiation. We've had great success and broad acceptance in many DMD centers [indiscernible] 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 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 AGAMAI including improvements in behavior, stature, bone health and cardiovascular health. We look forward to working with the participating centers of on enrollment and future data analyses. FICOMPA has established strong patient preference due to its proven efficacy and benefits in seizure control. [indiscernible] are proactively implementing targeted strategies to manage We anticipate a gradual revenue decline in the second half of twenty twenty five as physicians and patients prioritize clinical stability, 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 prioritizing strong clinical differentiation and a clear commercialization [indiscernible] While we have not yet found the right opportunity, we continue to make significant 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 DidoPharma successfully launched Firdapse in Japan. Expanding access for LEMS patients in this key market. Meanwhile, Cai Pharmaceuticals, our licensee in Canada, remains on track to submit a new drug submission [indiscernible] to help Canada in early twenty twenty five. [indiscernible] As part of our strategic focus, we remain vigilant in navigating market 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 Del Carmen, our Chief Jeff?

Thanks, Rich, and good morning, everyone. We are thrilled with our exceptional performance in 2024.

Marked by full year net product revenue of $489,300,000 and total revenues of $491,700,000 surpassing the upper end of our 2024 full year total revenue guidance of $475,000,000 to $485,000,000 This outstanding achievement was driven by Firdapse's full year revenue reaching a record high of $3.00 $6,000,000,000 the successful U. S. Commercial launch of AGAMRI and the continued strong contribution from FICampA. Let's start by reviewing our advancements with Firdapse. The only evidence based FDA approved treatment for Lambert Eaton myasthenic syndrome. In the fourth quarter, net product revenue amounted to 82,500,000.0 showcasing a remarkable 18.3% year over year growth, Furthermore, Firdapse's net product revenue 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% exceeding internal expectations. Prescription approval rates exceeded 90% 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 a gamma rate. 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 $46,000,000 surpassing the revised guidance of $40,000,000 to $45,000,000 In Q4, twenty twenty four, Agamri delivered strong net sales of 21,100,000.0 driven by increasing adoption. Adoption has been robust.

With 93% of the top 45 DMD centers of excellence and two zero nine unique healthcare providers enrollments for a gamma ray. We continue to see strong transitions from both corticosteroid segments with forty four percent coming from prednisone and forty three percent coming from Enflaza.

Additionally, eighty five percent of shipments were reimbursed with an average approval time of approximately 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 Fycampo. For the fourth quarter of twenty twenty four, FICIMPA delivered strong results supported by steady demand, that reinforced its market position. Q4 twenty twenty four net product revenue of $38,200,000 further strengthened our revenue diversification. VICOMPA's full year 2024 net product revenue reached $137,300,000 surpassing our guidance range of $130,000,000 to $135,000,000 To enhance our focus on the markets for Firdapse and Agamemri, we have made a strategic decision to divide our commercial field based team into two dedicated units. The Firdapse 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 Firdapse 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 Firdapse treatment will be a significant contributor.

Additionally, the approval of the expanded one hundred 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 eighty five percent of all cancer patients.

We expect that this strategic pivot will allow us to more effectively target the approximately ninety percent of small cell lung cancer LEMS patients who remain undiagnosed. Our efforts will center on implementing BG antibody screening programs with major GPOs, accelerating lens diagnosis rates.

In 2025, the dedicated field force will create deeper adoption of 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 for patients as they are evaluated for treatment of new therapies delaying initiation of a GAMRI for some patients. However, we remain confident that our dedicated AGAMRI field force will continue to expand Agamri's adoption across both prednisone and Enflaza segments. Finally, as we mentioned, by compolusis [indiscernible] We will continue to leverage personal promotion through LOE due to the promotional sensitivity with anti seizure medications. [indiscernible] 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'd like to highlight the incredible work done by the Catalyst team with the commercial launch of AGAMRI in March of twenty twenty four.

Now on to 2024 results.

Our total revenues for 2024 were $491,700,000 a 23.5% increase when compared to total revenues of $398,200,000 for 2023. Was $3.00 $6,000,000 an to $258,400,000 for 2023. [indiscernible] Product revenue net for GAMRI was $46,000,000 for the 2024 through year end. Product revenue net for FICOMPA was $137,300,000 compared to $138,100,000 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 Since our costs under these arrangements are higher than the size costs, we were impacted by an increase in gross net deductions for FICOMPA therapy causing a corresponding decrease in FICOMPA net product revenue. During 2024, we recognized a product which consisted primarily of a $2,100,000 milestone payment earned upon Dido receiving product approval to commercialize Firdapse for the treatment of patients with LEMS in Japan. 2023 license and other revenue was approximately $1,700,000 as a result of Dato submitting a Japan NDA for Firdapse to the Pharmaceutical and Medical Devices Agency in Japan.

For 2025, we are forecasting Firdapse net product to be between $355,000,000 and $360,000,000 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 Firdapse sales.

We expect that the IRA impact will continue to increase annually. We are forecasting a GAMRE twenty twenty five in net product revenue to be between $100,000,000 and $110,000,000 and we are forecasting VICOMPA twenty twenty five net product revenue to be between $90,000,000 and $95,000,000 In 2025, FICOMPA net product revenue will be impacted by the loss of exclusivity in the anticipated generic entrance into the Ficampza market. Finally, based on Daido's commercialization of Firdapse in Japan, we expect to record some revenue, which is included in the Firdapse guidance based on the sale of Firdapse to Dido in lieu of receiving royalties. [indiscernible] While we do not expect our 2025 revenue from sales to Dido to be material, we believe that our global expansion to make our product available to LEMS patients in other jurisdictions to be an important element of our business plan. We reported U. S. GAAP net income for 2024 of $163,900,000 or $1.38 per basic and $1.31 per diluted share. An increase of 130% year over year compared to GAAP net income for 2023 of $71,400,000 or $0.67 per basic and $0.63 per diluted share. The increase in net income year over year is attributable to growth in Firdapse's net product revenue and the addition of net product revenue resulting from the launch of AGAMRI.

Additionally, in 2023, we recorded the one time Agamri related $81,500,000 acquisition related IP R and D expense. Non GAAP net income for 2024 was $276,300,000 or $2.33 per basic and $2.21 per diluted share. Which excludes the income tax provision of $52,400,000 amortization of intangible assets related to our acquisitions of Resurgi, Vicompe and Agamri of $37,400,000 stock based compensation expense of $22,300,000 and depreciation of $397,000 from GAAP net income. This compares to non GAAP net income for 2023 of $141,600,000 or $1.33 per basic and $1.25 per diluted share which excludes the income tax provision of $23,100,000 amortization of intangible assets of $32,600,000 stock based compensation expense of $14,300,000 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 twenty twenty three, we acquired Agamemri commercial rights in advance of U. S. FDA approval which required that the company expense the acquired IPR and D at the time of the acquisition. Our cost of sales in 2024 was $9,000,000 $8,000,000 compared to $52,000,000 in 2023 and consisted principally of royalties. GAMRI royalties paid to the product licensure increased based on different net sales criteria.

For 2025, we expect the GammaRay royalties increase as a percentage of net sales compared to 2024 based on our net product revenue guidance of $100,000,000 to $110,000,000 Company is also required to make a $12,500,000 milestone payment to our product licensor once the Gamari's net product revenue in a calendar year reaches $100,000,000 Further, we are required to pay royalties based on net product revenue to the product licensor for FICOMP. Following the loss of exclusivity which will occur in May twenty twenty five 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 $12,600,000 in 2024 compared to $93,200,000 in 2023. As previously mentioned, the driver behind the decrease in research and development expenses relates to a one time Agamri IP R and D expense of approximately $81,500,000 during the third quarter of twenty twenty three. Relative to the normal course of business, absent another acquisition, we are forecasting research and development costs in 2025 to be between 15,000,000 and $20,000,000 We anticipate that our R and D expenses in future years may become more significant if we seek to for Firdapse and Agamemri or if we acquire additional products still in development.

SG and A expenses for 2024 totaled $177,700,000 compared to $133,700,000 in 2023. [indiscernible] increase in SG and A year over year is principally due to expenses related to Agamem. 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 and A expenses to increase primarily driven by increased headcount including full year costs individuals hired throughout 2024 in certain functional areas to support the growth of our business and our overall strategy, we focus on expanding our product portfolio. And the launch of separate commercial and medical field forces for Firdapse and Agamari, 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 We anticipate that our effective tax rate for 2025 will be relatively consistent with our 2024 and 2023 tax rates. [indiscernible] 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.

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, ended 2024 with cash and cash equivalents of $517,600,000 compared to $137,600,000 at 12/30/2023. The increase in cash of approximately $380,000,000 was largely driven by approximately $240,000,000 in cash provided by operating activities as well as approximately $141,000,000 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 and 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 ks which was filed with the Securities and Exchange Commission yesterday 02/26/2025, 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 I look forward to what we will accomplish together in the 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. Our first question comes from the line Charles Duncan with Cantor Fitzgerald. Please proceed with your questions. Congrats on a a great year of progress. I had a question about Firdapse and really the guidance I'm wondering if Jeff can provide a little bit more color on the new patient adds as well as the low discontinuation rate that you're seeing And then with regard to guidance for Firdapse, it's fairly narrow, $355,000,000 to $360,000,000 versus for example a gamma ray is broader and I'm kind of wondering why you have so much precision on the guidance at this at this stage with regard to Firdapse?

Charles, thanks for the question. Obviously, we have a lot more experience with Firdapse and I think Jeff I'll turn the call over to Jeff. But the pool of patients that we have and the confidence that we have in the brand and the uptake, I think Jeff can speak 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 Firdapse. Those patients typically contribute about fifty percent 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 how when we can help those patients transition on to 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 fifteen percent.

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 what how many enrollments you're going to get every given month. So that allows us and gives us confidence is to how we project or forecast 2025. Is that helpful, Charles?

Yes, it is helpful. And I had just one follow-up. In 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 FICAPA and perhaps revenue being reduced in 2026. Is it your plan to try to replace that revenue with another effort in epilepsy or are you [indiscernible] to do in terms of the FICA REVs in 2026? Thanks.

So from a business development standpoint, we remain open to orphan and differentiated products that we think can make a difference. So for patients, if it's epilepsy, we would stand behind the FICA 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 spend a lot more time in the future. If it's epilepsy and it's orphan, we would be interested in that. But we spent we have a very wide aperture for acquisitions or partnerships [indiscernible] 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 Bhavan 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 Maybe on M and A, 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.

Well, thanks for the question. Regarding the new indications so in the 10 ks, we did speak to some of the work that we're doing to further classify how we might go forward with Agamemri. 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, of course, our focus has been on the success of the launch of the Gamray 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.

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. This is something we track very, very closely We think about it in very similar ways that we think about our other opportunity 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, but 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 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?

Yes. That was great. Thank you guys. Really appreciate the help. Thank you. Our next question comes from the line of June Lee with Truist Securities. Please proceed with your question.

Congrats on the quarter and thanks for taking the questions. This is Assam Ronald on for June Lee. Just a question on the gross net you mentioned a gross net change referred to us in 2025. How much of a change will we expect from 2024?

And then what proportion of Firdapse patients are currently on the one hundred milligram dose? Thanks. First question, I will turn over to Mike and then the second Sure. Thanks, Rich. 2024, we saw a very small impact from the IRA. Less than one percent if you look at the gross commit. Thinking that based on the book of business that could be in the three percent to three point five percent range for 2025. And we'll continue to increase as a reminder we're under the small manufacturer so there's phased in approach. Over the 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. Patients, an additional two milligrams built in to the forecast for Fermas. At this time also, there are about twenty percent of our patients that are at about one hundred milligrams.

Thanks.

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

Hello. This is Benjamin Paolut on for Sam.

Thanks for taking our questions. Maybe starting with the GAMREIT can you speak to the factors that you expect to drive demand forward in twenty twenty five and that support your 2025 guidance of $100,000,000 to $110,000,000 How should we think about the cadence of the launch throughout the year?

Demand question?

Thanks for the question. And regarding a GAMRI, we mentioned the percent mix of the transition. So the boys living with DMD forty four percent coming from the prednisone segment and about forty three percent 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 come from Enflaza for a variety of reasons. So having that gives again gives us confidence. We continue to expect transitions from both segments moving forward at a steady pace. I did mention competitive landscape that we're seeing. So what we expect [indiscernible] 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 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? Yes, that's helpful. Thank you so much. And then maybe moving over to Firdapse. 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.

Yes, 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 LEMS or cancer associated LEMS. Segment. And we expect in 2025 to really focus on initiating or getting screening programs in implemented. So it's really about helping those ninety percent of undiagnosed small cell lung cancer LEMS 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. So I'll just add to that. We've done a 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 of 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 majority, 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 can 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 Pantazaro with Piper Sandler. Please proceed with your question. Great. Hey, everybody. Thanks for taking my questions. Maybe first one following up up on those recent comments you made, Jeff, on the queuing effect you're seeing in DMD. Wondering if you could elaborate a little bit more on what you mean by the queuing effect and anything you guys can do to shorten the time a patient spends in that queue and maybe somewhat relatedly what you've seen or heard that is led you to make the decision to separate the sales force preferred apps and Agamri later this year. Thanks. And I have [indiscernible] Thanks for the question. And first thing, 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 and of age and older regardless of ambulatory status to be eligible or considered for a levidis treatment. When that happened, a lot of patients and their families and healthcare providers wanted to see if they could be evaluated or are they a fit for levidis treatment?

So this is just an example So when that happens, these patients and 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 sixty days post ELEVADIS treatment before they will consider switching their steroid. So it's that type of queuing 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 Agamri We just see it as a slight delay for initiation to a gamma ray for some patients. Is that helpful, Jeff?

Yes, that's helpful. Follow-up on FICampza. I know historically you guys have said that the epilepsy market could be resilient to generic wondering if your guidance for twenty twenty five factors some of that resiliency in. And I think you alluded to this a little bit, but any new efforts You'll employ to maybe slow that erosion trajectory? Thanks. Yes.

So we see the resiliency there. Obviously, we have the opportunity to sell the products with under the patent through the May. On the solid dose and then the suspension through the November. So we're excited about that and 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 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. So 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, forgot to respond to your 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 focus to 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 Firdapse, when you evaluate the LEMS opportunity with Firdapse, 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 preferred apps Also, that will allow us for those deeper relationships to help find these patients and help these patients get diagnosed and transition to Great. Thank you. Appreciate you circling back on that. Thanks for taking my questions. Thanks, Joe. Thank you. Our next question comes from the line of Joel Beatty with Baird. Please proceed with your question. Thanks for taking the questions. The first one is related to OGMRI.

In the competitive DMD marketplace, what are you seeing in terms of generic erosion for Emflaza And how much could that impact the opportunity for a gamma ray to grow? [indiscernible] your question. We have not seen much generic entrant into this or conversion from branded at this point from what we've seen. We haven't seen much and we don't see that impacting Reacted to a gamma ray because of generic in Plaza. So that's what gives us confidence that we'll have minimal impact to a gamma rate in 20 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 Emflaza, making them step back to a generic Emflaza not likely to happen. So right now and for the foreseeable future with this 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 Plaza it's just not likely to happen at this time and again for the foreseeable future. Does that make sense? Yes, that does make sense. Thank you. And then maybe one last last question related to SG and A. Into twenty twenty five.

In the prepared remarks, you mentioned an increase this coming year. Could you quantify that at all?

We haven't quantified. If you recall, we did not quantify last year either. Are expecting the increase as we laid out and we'll give a little bit more clarity as the year progresses. In part, how long does it take to fill up in positions, etcetera?

Thank you.

Thank you. Our next question comes from the line of Levin Durschl with Oppenheimer. Please proceed with your question. Hey, Leila.

Hey, this is Rowan on for Leeland.

Thanks for taking my question. How are you doing?

Just a How are you? Just a couple of questions from me. Now that we have greater clarity on the Firdapse 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 structured 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 is a really good one. As we look at the opportunity, should we end up with a full ten year opportunity we would look at it as if it's a brand that's going to be on the market for ten 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 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 the business Lifecycle management has many forms. It could be through research, it could 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 The States tend to see greater brand adherence than in others.

And could you speak to the maybe what you're seeing commercially that is driving the lower guidance?

So what will happen, 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 will deliver through the May, a generic come on the market in June? But once it goes off patent, some patients are price sensitive. Some patients are brand sensitive that want to maintain and that's a special epilepsy market.

There will be some contracting we'll do with payers to to maintain our position that will be an erosion of price and we will lose some volume. So there'll be a mix of price and volume. But as I said in response to 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. Our next question comes from the line of Sudan Loganandaan with Stephens.

Please proceed with your question.

Congrats on the call. This is [indiscernible] Sudan LUKINETAN [indiscernible] Given the fact that the products have done very well in the marketplace, How well have you penetrated the [indiscernible] If you can give color on the percent that will be very helpful. And then one other question is on the SUMMIT trial for AGAMRI. If you can give us a potential legal expansion opportunity it's out there, that would be helpful for us to model the company very well. Sorry, the second part of the question was Summit, was that Summit?

Okay.

Yes.

So in January at JPMorgan, we gave a a market valuation for LEMS at over 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 $1,000,000,000 The lens market is valued at over $1,000,000,000 So to just give a very simple answer, what's our market penetration, last year we sold $3.00 $6,000,000 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 any other two suits, we have a runway is prevail in a similar way with the other two suits. We have a runway of ten years and we're all [indiscernible] 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 OGMRI 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 are not 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 into the public. The fastest way to do that is through posters, presentations, abstracts, [indiscernible] label expansion, depends upon the overall strength and amount of data We certainly have planned and look forward to the study, but 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.

Thanks, Gary. 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. May disconnect your lines at this time. We do thank you for your participation.