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

Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's first quarter 2025 financial results and business highlights. Leading the call today is Richard Daly, Catalyst's President and Chief Executive Officer. We are also joined by Jeff Del Carmen, our Chief Commercial Officer. Further for the Q&A session, Dr. Steve Miller, our Chief Operating Officer and Chief Scientific Officer will be available for questions. Before we begin, I would like to remind you that in our remarks this morning and in the Q&A session, we will make statements about expected future results, which may be forward-looking statements for purposes of federal securities laws. These statements relate to our current expectations, estimates and projections and are not guarantees of future performance. They involve risks, uncertainties and assumptions that are difficult to predict and may not prove to be accurate. Actual results may vary from the expectations contained in our forward-looking statements. These forward-looking statements should be considered only in conjunction with the detailed information contained in our SEC filings, including the risk factors described in our recent 2024 Annual Report on Form 10-K filed with the SEC on February 26, 2025, and our first quarter 2025 quarterly report on Form 10-Q, which was filed yesterday, May 7, 2025 with the SEC. At this time, I’ll turn the call over to Rich. Rich?

Thanks, Mike. Good morning, everyone, and thanks for joining us. Catalyst delivered an outstanding start to 2025 with continued excellent execution, strong demand for our rare disease therapies and continued progress on key strategic priorities. These results highlight our sustained momentum and growing impact in the patient communities we serve. Total net revenues grew 43.6% year-over-year to $141.4 million with meaningful contributions from each of our products. These results highlight the strength of our portfolio and the effectiveness of our commercial execution. With a strong cash position of $580.7 million and disciplined operational management, we are well-positioned to drive long-term growth while advancing our strategic priorities. Let’s turn to the specifics of our commercial performance beginning with FIRDAPSE. FIRDAPSE continues to demonstrate outstanding performance maintaining its position as the only evidence-based approved product in the U.S for the Lambert-Eaton myasthenic syndrome or LEMS. In the first quarter of 2025, the brand delivered another strong quarter of organic growth generating revenue of $83.7 million, an increase of 25.3% year-over-year. Performance was driven by continued adoption among newly diagnosed patients and a modest tailwind from normalized prescription activity following temporary disruptions related to the Change Healthcare cybersecurity incident in quarter one 2024. The effect of which we expect to level out in Q2 2025. Mike will discuss the impact of the Change Healthcare cybersecurity incident in more detail in his remarks. In addition, since the 100-milligram label expansion for FIRDAPSE approved in May 2024, we've seen an increase in the average daily dose of FIRDAPSE. The 100-milligram enhancement offers providers greater flexibility to individualize therapy based on patient needs. We expect the average daily dose to increase in the near term. As we've stated in the past, approximately half of all LEMS diagnoses are associated with cancer, in particular small cell lung cancer. We continue to work with the National Comprehensive Cancer Network to improve the understanding of the relationship between LEMS and cancer, the role of EGCC testing and the benefits of treating LEMS associated cancer patients with FIRDAPSE. These initiatives reflect our strategic approach to extending FIRDAPSE's market leadership and positioning the brand for durable long-term growth. This continued performance reinforces our confidence in delivering FIRDAPSE's 2025 net product revenue forecast of between $355 million and $360 million. Now turning to AGAMREE. AGAMREE delivered a solid performance in Q1 2025, marking its first full year of commercial availability following a March 13, 2024 U.S launch. Net product revenues totaled $22 million compared with $1.2 million in Q1 2024, reflecting the impact of a full quarter of sales compared to the prior year, sustained organic uptake and increased confidence in AGAMREE's potential as a differentiated corticosteroid treatment for Duchenne muscular dystrophy or DMD. AGAMREE continues to source patients from branded and generic competitors in a balanced manner as it has since launch and the patient retention rate remains robust. We believe these are indications of the market sensing AGAMREE's potential benefits. Prescriber engagement continues to build supported by the full deployment of our dedicated AGAMREE field team in April 2025. These early commercial indicators position AGAMREE for broader market reach as foundational complementary corticosteroid therapy within the evolving DMD treatment landscape. This momentum continues to support our full year 2025 net revenue forecast for AGAMREE between $100 million and $110 million. On the clinical front, we are advancing the SUMMIT Study, our 5-year real-world evidence-based study evaluating long-term outcomes in DMD patients treated with AGAMREE. During the first quarter of 2025, the SUMMIT Study advanced with the activation of additional sites and continued progress in patient enrollment. We hope that the results of the SUMMIT Study will provide long-term real-world evidence of the benefits of the treatment of AGAMREE. And finally, FYCOMPA. FYCOMPA delivered solid results in this quarter, driven by steady demand and disciplined execution to maximize near-term value ahead of the anticipated generic entry on or after May 23, 2025. Net product revenue for the period was $35.6 million, representing a year-over-year growth of 17.1%, driven by sustained performance, strong patient preference and the product's well-established clinical role in seizure control. As we approach the end of exclusivity, we remain focused on ensuring continuity of care and managing the brand's value through well-planned transitions. As discussed previously, we expect a measured revenue decline post-patent expiry. Our teams are fully prepared and executing against a defined strategy to manage this evolution effectively. We believe that FYCOMPA remains on track to deliver on our 2025 full year net product revenue forecast of between $90 million and $95 million as we continue to maximize near-term value. In parallel, we remain committed to expanding access to our rare disease therapies in markets outside the U.S. In January, our sub-licensee, DyDo Pharma, successfully launched FIRDAPSE in Japan, making it the first approved treatment for LEMS. This important milestone expands access for an estimated 1,200 LEMS patients and addresses an important unmet need in the Japanese rare disease patient community. In Canada, our sub-licensee, Kye Pharmaceuticals, which also markets FIRDAPSE in Canada, is advancing regulatory plans for AGAMREE. In April of 2025, Health Canada accepted the new drug submission under priority review with the potential of approval by year-end. If approved, AGAMREE would be the first authorized treatment for DMD in Canada, addressing a patient population of more than 800 individuals and making a meaningful advancement in care of this underserved DMD community. While these license agreements are not expected to contribute materially to revenue, they are aligned with our broader mission to advance health equity by expanding access to our therapies for underserved patient populations. We continue to take strategic action to safeguard the long-term value of the FIRDAPSE franchise. In January, we reached a favorable settlement with Teva restricting U.S. generic entry until February 25, 2035, subject to certain conditions. Litigation with the two remaining first filers remains ongoing and we remain confident in our strength of our intellectual property portfolio. However, there could be no assurances that we will prevail in this litigation. Business development continues to be a core growth lever for Catalyst. We remain disciplined in our approach, prioritizing opportunities with strategic synergy, clinical differentiation and the potential to drive long-term value. With a robust pipeline of evaluations underway, we believe that we are well-positioned to execute transactions that further enhance our leadership in rare disease. As we advance through 2025, we remain firmly focused on executing our strategic priorities and sustaining operational excellence with a strong foundation, high-performing team and a clear path to value creation. We believe that we are well-positioned to deliver durable growth while continuing to elevate care for patients living with rare diseases. We are reaffirming our full year total product revenue guidance of between $545 million to $565 million. We believe Catalyst is well-positioned to create a meaningful value for patients, health care providers and our stakeholders. With that, I’ll now turn the call over to Jeff Del Carmen, our Chief Commercial Officer.

Thanks, Rich. Good morning, everyone. Q1 marked another record quarter for our commercial organization, reflecting strong execution across the portfolio and continued demand for our innovative therapies. As Rich mentioned, Catalyst had an excellent start to 2025 driven by the combination of sustained organic growth of FIRDAPSE, stable revenues from FYCOMPA and the steady adoption of AGAMREE. Q1 total net revenues of $141.4 million positions Catalyst well to achieve our combined 2025 total revenue guidance of $545 million to $565 million. Also, I am pleased to report that we successfully completed the commercial field team restructuring, establishing dedicated sales teams for AGAMREE and FIRDAPSE. This realignment strengthens our focus within each therapeutic area and sets a strong foundation for future growth. Let me walk through key performance highlights by product. First, I will start with FIRDAPSE performance. Q1 FIRDAPSE net product revenue of $83.7 million represents a 25.3% increase quarter over the same quarter last year, a direct result of strong new patient starts and a low annual discontinuation rate of approximately 15%. Prescription approval rates were greater than 90% across all payers, government or private commercial insurers. We continue to see strong leading indicators in April, furthering our confidence in achieving FIRDAPSE full year net product revenue guidance of $355 million to $360 million in 2025. As we look ahead, our strategic growth initiatives remain a key driver for organic growth. We continue to maintain a pipeline of greater than 500 potential LEMS patients in various stages of their diagnostic journey who have not yet started treatment with FIRDAPSE, representing roughly 50% of our new patient enrollments each quarter. Furthermore, we're particularly excited about the opportunity in cancer-associated LEMS, where we are expanding our focus to the community oncology channel, which manages the majority of cancer care in the U.S. We are confident that potential BGCC antibody screening arrangements with GPOs in the second half of 2025 will help accelerate LEMS diagnosis rates in the approximately 90% of small cell lung cancer LEMS patients who are currently undiagnosed. Next, I would like to discuss AGAMREE. We are proud of the continued early market momentum of AGAMREE and its growing presence in the market as a breakthrough treatment for DMD as evidenced by Q1 net product revenue of $22 million. Since the commercial launch of AGAMREE in March 2024, 93% of the top 45 DMD centers of excellence and 224 unique healthcare providers have submitted an enrollment form for AGAMREE. We continue to see transitions to AGAMREE from both corticosteroid segments, 44% from prednisone and 44% from Emflaza. Approximately 85% of shipments are successfully reimbursed, which is aligned with our forecast. In addition, our dedicated AGAMREE sales force is actively executing targeted educational initiatives to reinforce AGAMREE's potential for differentiated value, driving durable patient uptake and strengthening our competitive position. AGAMREE's net product revenue for 2025 is expected to be between $100 million and $110 million, reflecting its continued market adoption and commercial momentum. Lastly, I would like to provide a brief overview of FYCOMPA. FYCOMPA delivered solid Q1 net product revenues of $35.6 million, further fortifying our revenue diversification. Looking ahead, we are closely managing the upcoming FYCOMPA loss of exclusivity. While we anticipate revenue impact in the second half, we have mitigation plans in place to appropriately minimize brand erosion. We remain confident in our full year 2025 net product revenue forecast for FYCOMPA of between $90 million and $95 million. To summarize, our commercial organization continues to execute with precision supported by a strong field force and focused strategies across our portfolio. Following a strong first quarter and sustained momentum across the business, we are confident in reaffirming our full year 2025 total revenue guidance. We believe that we are well-positioned to seize the growth opportunities ahead and we remain focused on driving operational excellence, enhancing patient access and scaling our commercial impact across our entire product portfolio. I will now turn the call back over to Mike.

Thanks, Jeff. Our performance during the first quarter of 2025 has set us on pace for another strong year driven by our solid financial performance, financial discipline and strong execution. With the continued success from the launch of AGAMREE in mid-March of 2024, along with the continued performance of FIRDAPSE and FYCOMPA, we have set the groundwork for what promises to be yet another strong year in 2025 and we reaffirm our 2025 full year total revenue guidance that we provided in February. We remain steadfast in our commitment to driving growth, leveraging strategic arrangements and expanding our portfolio to capitalize on emerging opportunities throughout the year. Our total revenues for the first quarter of 2025 were $141.4 million, a 43.6% increase when compared to total revenues of $98.5 million for the first quarter of 2024. Product revenue net for our lead product FIRDAPSE was $83.7 million, a 25.3% increase year-over-year compared to $66.8 million in Q1 2024, primarily driven by an increase in sales volumes, a portion of which is attributed to a delay in patient claims to certain non-Medicare payers in certain states resulting from the Change Healthcare cybersecurity incident that occurred in the first quarter of 2024 and was resolved in the second quarter of 2024. The first quarter of 2025 also reflects a small amount of revenue for shipments to sub-licensees outside of the U.S. Product revenue net for the first quarter of 2025 for AGAMREE was $22 million compared to $1.2 million in the first quarter of 2024. As mentioned earlier, AGAMREE was made commercially available in mid-March 2024. The results underscore continued growth and increasing prescriber engagement. Product revenue net for the first quarter of 2025 for FYCOMPA was $35.6 million compared to $30.4 million in the first quarter of 2024, which included a reduction in variable consideration or gross to net, resulting from a decrease in wholesaler distribution fees in 2025. We expect that product revenue net for FYCOMPA will likely decrease once the patent protection expires, which occurs on May 23, 2025 for the tablets and on December 15, 2025 for the oral suspension. Net income before income taxes for the first quarter of 2025 was $71.3 million, a 145% increase year-over-year compared to $29.1 million for the first quarter of 2024. We reported GAAP net income for the first quarter of 2025 of $56.7 million or $0.47 per basic and $0.45 per diluted share, an increase of 144% year-over-year compared to GAAP net income for the first quarter of 2024 of $23.3 million or $0.20 per basic and $0.19 per diluted share. As a reminder, in the first quarter of the calendar year, like many companies in our industry, we are impacted by the reset of patient insurance deductibles. Cost of sales expense was approximately $17.9 million in the first quarter of 2025 compared to $12.5 million in the first quarter of 2024 and consisted principally of royalties. AGAMREE royalties paid to the product licensor increased by 2% when AGAMREE's net product revenue exceeds $100 million in any calendar year. The company is also required to make a $12.5 million milestone payment once AGAMREE's net product revenue reaches $100 million, which will be capitalized once achieved and amortized as part of cost of goods sold over the remaining estimated useful life of the intangible asset. Non-GAAP net income for the first quarter of 2025 was $86.6 million or $0.71 per basic and $0.68 per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FYCOMPA, AGAMREE and other expenses of $9.3 million, stock-based compensation expense of $5.9 million, the income tax provision of $14.5 million and depreciation of $115 million. This compares to non-GAAP net income in the first quarter of 2024 of $46.8 million or $0.40 per basic and $0.38 per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FYCOMPA, AGAMREE and other expenses of $9.3 million, stock-based compensation expense of $8.2 million, the income tax provision of $5.8 million and depreciation of $86,000. Our effective tax rate for the first quarter of 2025 was 20.4% compared to 20% for the first quarter of 2024. We expect the 2025 annualized effective tax rate to be relatively consistent with the 2024 annual rate of 24.2%. For the first quarter of 2025, the difference to the statutory federal income tax rate of 21% was primarily driven by state income taxes, fluctuations in the value of investments and anticipated annual permanent differences. 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. Further, we are required to pay royalties based on net product revenue to the product licensor for FYCOMPA following the loss of exclusivity, which will occur later this month for tablets and in December 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. As a reminder, royalties for FIRDAPSE increased by 3% when net product sales exceed $100 million in any calendar year. As a result, we expect cost of sales to trend higher as the year progresses. Additionally, I would like to note that AGAMREE also carries the royalty in the range of low double-digit to mid-20% depending on sales achievements within a calendar year. Further details on our royalty obligations for AGAMREE are disclosed in our Q1 2025 Form 10-Q and are expanded upon within the MD&A section. Research and development expense was $3.9 million in the first quarter of 2025, up from $2.6 million in the first quarter of 2024. During the three months ended March 31, 2025, research and development expenses consisted of costs for company-sponsored research and development activities, support for selected investigator-sponsored research and support for our commercial activities. The company anticipates full year 2025 research and development expenses to range between $15 million and $20 million excluding the impact of any additional acquisitions, reflecting investments in the SUMMIT Study and the start of initiatives to investigate the potential for AGAMREE's label to be expanded in the future. SG&A expenses for the first quarter of 2025 totaled $46.9 million flat as compared to $46.9 million in Q1 2024. However, at this point, SG&A expenses are expected to increase modestly over the remainder of the year, reflecting personnel additions during 2024 and the strategic alignment of dedicated commercial teams supporting FIRDAPSE and AGAMREE, which became effective in the start of the 2025 second quarter. As reported, we ended the first quarter of 2025 with cash and cash equivalents of $580.7 million compared to $517.6 million at December 31, 2024. The increase in cash of $63.1 million was largely driven by $60 million in cash generated from operations of our business. We believe our current funds 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 first quarter 2025 financial performance may be found in our quarterly report on Form 10-Q, which was filed with the Securities and Exchange Commission yesterday, May 7, and can be found in our Investor Relations page on our website at www.catalystpharma.com. And with that, I will turn the call back over to Rich.

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

Thank you. Our first question will come from Joon Lee with Truist Securities. Please go ahead.

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

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

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

To summarize, even when factoring out the impact of Change Healthcare, you would still be within the 15% to 20% growth range, correct Jeff?

Absolutely.

Yes, Asim, is that clear?

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

Percent of tablet versus suspension.

It's probably about 98% tablet.

Okay. Thank you. Very helpful.

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

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

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

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

Thank you.

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

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

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

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

So when you say smaller scale, can you clarify?

Is this something you've been able to test in certain locations or in relation to antibody tests? Are we still early in these efforts? You've had significant success in marketing non-cancer associated LEMS, but this is a different approach. What makes you confident that you can achieve success in this area as well?

Great. Let me start and then I will hand it over to Jeff. In our discussions with the oncology community, we have definitely observed interest in this matter. We are engaging with larger oncology groups, many of which have consolidated their practices. These groups recognize that a significant percentage of patients with small cell lung cancer associated with LEMS are not receiving treatment. They understand the unmet clinical and medical need. When we discuss the potential for diagnosis and subsequent treatment, there is clear interest. Jeff, do you want to add to this?

There has been significant engagement with thought leaders over the past couple of years. As Rich mentioned, there is considerable interest among these key opinion leaders. Our aim is to facilitate seamless testing for patients so that the 90% who remain undiagnosed can receive testing and hopefully a diagnosis. In our discussions, physicians acknowledge the unmet need for patients with small cell lung cancer, indicating robust interest within the oncology community.

Okay. Thank you.

Joel, is that helpful?

Yes, it was.

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

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

Source of our conservatism, Charles?

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

Okay. Jeff, do want to take that?

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

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

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

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

Okay. Last question on business development, helpful insights so far. Given the market and the environment, it seems to align well with your approach and your cash position. Do you have specific goals for this year to finalize a transaction? Or is that something you prefer not to commit to at this moment?

I wouldn't say we have a specific goal to complete a transaction. Our goal is to secure the right transaction or the right transactions. As a company, we have done an excellent job of acquiring the appropriate assets, and we intend to maintain that trend. It's important for us to ensure that we bring in the right assets. We have evaluated many opportunities, but for various reasons, they haven't aligned with our needs or made sense for us. It would be unfortunate to pursue an opportunity that doesn’t fit us culturally, financially, or structurally. All of these factors need to align. We consider ourselves very selective buyers and acquirers of assets, and we aim to continue this practice because we believe it benefits our shareholders and the company. So, while I'm not trying to be evasive, our goal is to pursue the right deal.

Okay. Thanks for taking all my questions.

Thanks for your support too as well.

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

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

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

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

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

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

Thank you.

Thank you.

Thanks, Rohan.

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

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

Thank you, Jason. We will hand over the first part of your question to Mike, and then Jeff will address the second part.

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

If you exclude what occurred in the first quarter of '24, we are still projecting growth in the range of 15% to 20%. Does that clarify things?

Yes, definitely.

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

Yes. Just how Q1 may have been impacted at all like sort of the momentum you’re seeing on small cell lung LEMS pick up relative to I guess baseline or year-on-year comp?

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

Got it. Okay, thanks so much.

Thanks, Jason.

Thank you. Our last question will come from Sudan Loganathan with Stephens. Please go ahead.

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

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

As Rich mentioned, there is a significant opportunity in both segments of LEMS prevalence. We anticipate increased potential to assist small cell lung cancer LEMS patients moving forward. Currently, the penetration for idiopathic LEMS is strong, but there remains ample opportunity. Among the approximately 500 pipeline patients who are in various stages of their diagnostic journey, the majority are idiopathic LEMS patients. Therefore, we have plenty of short-term opportunities to support them as well. Both segments still present substantial opportunities.

Thanks, Jeff. Appreciate it. Any other questions?

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

Thank you.

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