CATALYST PHARMACEUTICALS, INC. — Call Transcript 2025

Meetings. Welcome to the Catalyst Pharmaceuticals' second quarter 2025 financial results conference call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star then zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to the Chief Financial Officer, Mike Kalb. Please go ahead, sir. Thank you. Good morning, everyone, and thank you for joining our conference call to discuss Catalyst Pharmaceuticals' second quarter 2025 financial results and business highlights. Richard Daly, President and CEO, will lead the call today, and Jeffrey Del Carmen, our Chief Commercial Officer, and I will also present. Additionally, Dr. Steven Miller, our Chief Operating Officer and Chief Scientific Officer, and Dr. Will Andrews, our Chief Medical Officer, will be available for the Q&A. Before we begin, I 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 reflect our current expectations, estimates, and projections, and do not guarantee future performance. They involve risks, uncertainties, and assumptions that are difficult to predict and may not prove to be accurate. Actual results may vary from the expectations contained in our forward-looking statements. These forward-looking statements should be considered only in conjunction with our detailed information contained in our SEC filings, including the risk factors described in our 2024 annual report on Form 10-K filed with the SEC on February 26, 2025, and in our second quarter 2025 quarterly report on Form 10-Q, which was filed yesterday, August 6, 2025, with the SEC. At this time, I'll turn the call over to Rich. Rich? Thanks, Mike. Good morning, everyone, and thank you for joining us. Catalyst delivered another record-setting quarter in Q2 2025, with total revenue reaching $146.6 million, an increase of 19.4% year-over-year. For the first half of 2025, total revenue grew 30.2% to $288 million, reflecting strong execution and sustained demand for our differentiated portfolio. We ended the second quarter of 2025 with a cash position of $652.8 million, reinforcing our ability to invest strategically for long-term growth. Based on strong leading indicators, we remain confident in our trajectory and believe that we are on track to achieve our full-year 2025 revenue guidance of $545 million - $565 million. Our outstanding progress is underpinned by the balanced performance of our commercial portfolio, which continues to deliver consistent growth and a positive impact on patients. Let's dive deeper and start with FIRDAPSE. FIRDAPSE generated net product revenue of $84.8 million in Q2 2025, a growth of $7.5 million versus Q2 2024. As we discussed in our Q1 2025 earnings call, last year's second quarter results reflect the timely impact of the February 2024 Change Healthcare Cybersecurity Breach on our year-over-year growth rate. The temporary impact of the Change Healthcare Security Breach, which shifted volume from Q1 2024 to Q2 2024, was fully resolved by the end of June 2024. As a result, we believe that comparing FIRDAPSE's first half 2025 performance to the same period in 2024 provides the most accurate view of the franchise's continued strength. Importantly, the underlying demand remains strong, consistent, and durable. Year to date, FIRDAPSE has delivered $168.6 million in net product revenue, representing a 16.9% increase over the first half of 2024. In 2025, our sales of FIRDAPSE have returned to their expected cadence, and we reaffirm our full-year 2025 net product revenue guidance of $355 million - $360 million. We are confident that FIRDAPSE remains well-positioned for sustained organic growth, supported by consistently high prescription approval rates and a robust pool of patients progressing through their diagnostic journey. This strong and visible demand underscores the durability of our franchise and reinforces our leadership in addressing the needs of the LEMS patient community. To unlock the next phase of growth for FIRDAPSE, we are actively advancing a focused expansion strategy centered on education of HCPs supported by the recent updated NCCN guidelines. Since we believe that potentially 90% of cancer-associated LEMS patients remain undiagnosed, we see a meaningful opportunity to expand our reach in this high-potential underserved population. We expect momentum to build in the months ahead, setting a stage for sustained growth in 2026 and beyond. Jeff will cover the specifics in his section of the call. While FIRDAPSE continues to perform well, we are equally encouraged by the accelerating adoption and performance of AGAMREE. AGAMREE continues to outperform expectations, generating $27.4 million in net product revenue in Q2 2025, a new post-launch high and a 213% increase year-over -year from Q2 2024. First half net revenues reached $49.4 million, up 398% from the prior year, driven by steady conversion from both prednisone and deflazacort, a strong 90% patient retention rate, and growing adoption across the Duchenne Centers of Excellence. AGAMREE's commercial execution is tracking well, with strong patient retention and increasing prescriber engagement, further supported by our full deployment of our dedicated field team. Continued transitions from both branded and generic therapies, along with growing market receptivity and payer alignment, reinforce our confidence in meeting our full-year outlook. Backed by focused commercial strategy, AGAMREE is well-positioned to continue momentum. We are reaffirming AGAMREE's full-year 2025 net product revenue guidance of $100 million - $110 million. Let's switch to FYCOMPA. FYCOMPA delivered solid results in the second quarter of 2025, with revenue of $34.3 million, reflecting a year-over-year decrease of 6%. First half 2025 revenue reached $70 million, up 4.5% from the same period last year. We anticipate the impact of generic competition going forward, and our full-year net product revenue guidance of $90 million - $95 million for FYCOMPA remains unchanged. We recently strengthened our corporate and board leadership. I'd like to formally welcome Dr. Will Andrews as our new Chief Medical Officer. Will joined Catalyst on June 2nd, 2025. Will brings deep pharmaceutical expertise in rare diseases, spanning clinical development, medical affairs, business development, and portfolio strategy. His leadership will ensure scientific rigor and operational excellence as we continue to differentiate AGAMREE within the Duchenne treatment landscape and further solidify our position in the LEMS community. Will's role in leading our medical function is foundational to ensuring the long-term success of our portfolio. For AGAMREE, Will is leading the Summit study, which aims to generate real-world evidence in support of the appropriate use of AGAMREE. To date, the study has initiated 19 sites, with patient enrollment progressing. As the study progresses, we will provide updates when the interim data becomes available. In parallel, Will is overseeing the execution of our phase I study, comparing AGAMREE, prednisone, and deflazacort to determine a potential switching algorithm. Additionally, we are working to assess the immunosuppressive effects of AGAMREE that could help us define the lifecycle management potential for AGAMREE. Initial results are expected by the end of 2025 to early 2026. Will's expertise and insights also enhance our strategic perspective as we advance growth initiatives aligned with our long-term vision. This past Monday, we announced that Dr. Dan Curran joined our Board of Directors. We are pleased to welcome Dr. Curran to our Board of Directors. He brings deep experience in rare disease and a strong track record in business development and strategic growth. His experience advancing transformative therapies and building value across the development continuum aligns well with our mission and growth strategy. On the business development and IP front, we remain highly disciplined in employing our business development strategy, actively evaluating a broad range of opportunities that align both strategically and financially with our long-range plan. Our commitment to value-driven growth is unwavering, and we are confident that our focused and deliberate approach will position us to capitalize on the right opportunities. In parallel, we are advancing on our initiatives to protect and enhance the long-term value of our portfolio. We are still awaiting a trial date in our ongoing patent litigation for FIRDAPSE with our remaining first filers, but anticipate it to be in Q4 2025 or Q1 2026. We expect more clarity on this issue on or after our Markman hearing, which is scheduled for October 7th, 2025. We remain committed to updating our performance related to environmental, social, and governance reporting. In June, we published our 2024 ESG report, underscoring our commitment to sustainable growth and responsible innovation. This report is available on the Catalyst website. In summary, we are entering the second half of 2025 with strong momentum, clearly defined growth drivers, and a focused strategy to deliver long-term value and impact for patients. With that, I'll turn it over to Jeff, who will provide additional insights into our commercial performance. Thanks, Rich. Q2 marked another record-setting quarter for our commercial organization, underscoring continued strong execution across the portfolio and sustained demand for our differentiated therapies. As Rich noted, Catalyst delivered sustained organic growth from FIRDAPSE, strong revenues from FYCOMPA, and accelerating adoption of AGAMREE. Q2 net product revenue of $146.5 million puts us firmly on track to meet our 2025 guidance, reflecting the strength of our neuroscience business. FIRDAPSE remains the only evidence-based FDA-approved treatment for Lambert-Eaton myasthenic syndrome. The brand continues to perform well across both neurology and our emerging oncology segments. FIRDAPSE continues its strong multi-quarter growth trajectory, driven by durable demand and consistent execution. Prescription approval rates remained above 90% across both government and commercial payers, and discontinuation rates were in line with expectations, tracking below an annualized rate of 20%. These indicators reflect strong patient adherence and reinforce the foundation for sustained performance. Leading indicators, including steady growth in new patient starts and refill volumes through July, continue to trend positively, reinforcing our confidence in achieving full-year 2025 FIRDAPSE revenue guidance. We continue to advance our patient identification efforts and continue to have a pool of over 500 LEMS patients in active diagnostic stages. These patients consistently account for approximately half of new starts each quarter, giving us confidence in driving sustained organic growth. To further unlock the next phase of growth for FIRDAPSE, we are actively advancing a focused expansion strategy centered on HCP education, which is supported by the recently updated NCCN guidelines for small cell lung cancer, broadening access to VGCC antibody testing, streamlining the diagnostic journey, and accelerating adoption across oncology and neurology settings. By improving diagnosis, particularly in small cell lung cancer patients, and increasing recognition of patients often misdiagnosed with myasthenia gravis, we hope to meaningfully expand the addressable population and drive sustained growth within what we believe is a more than $1 billion addressable market opportunity. As we advance these priorities, we are implementing a three-step program of targeted initiatives designed to enhance diagnostic access and clinical recognition across key market segments. First, we are deploying a frictionless testing model that makes it easier for physicians and particularly oncologists to order VGCC antibody screening directly within their practices, eliminating referral delays and helping to significantly reduce time to diagnosis. These efforts represent progress in advancing important diagnostic initiatives to help improve LEMS patient outcomes and accelerate the adoption of FIRDAPSE. Second, we are pleased to share that ahead of schedule, the NCCN published updated guidelines for small cell lung cancer on July 25th, which now include VGCC antibody testing and recommend that amifampridine should be considered as a treatment for cancer patients with LEMS. This milestone strengthens our ability to expand access, accelerate diagnosis, and help drive FIRDAPSE adoption in oncology. Most importantly, it represents meaningful progress in improving care for cancer patients living with LEMS. Our third step involves forging strategic partnerships with leading oncology practices to update care pathways, which are generally structured plans that outline the steps and interventions required for patient care, ensuring standardized and efficient treatment for specific conditions. We plan to execute comprehensive education and promotion programs to ensure broad understanding and integration of the care pathways. Due to the early updating of the NCCN guidelines, we are accelerating our investment in educating HCPs on the new guidelines and working to incorporate diagnostic and treatment recommendations into the care pathways in targeted large group oncology practices. Since we believe that potentially 90% of cancer-associated LEMS patients remain undiagnosed, we see a meaningful opportunity to expand our reach in this high-potential underserved population. We expect momentum to build in the months ahead, setting the stage for sustained growth in 2026 and beyond. Turning to AGAMREE, AGAMREE continues to demonstrate strong early market momentum as a differentiated treatment for Duchenne muscular dystrophy. Q2 2025 net product revenue was $27.4 million. Adoption continues to expand across key centers. To date, 93% of the top 45 DMD Centers of Excellence and 231 unique healthcare providers have submitted enrollment forms. In Q2, approximately 43% of patients transitioned from prednisone and 42% from deflazacort, underscoring AGAMREE's broad clinical relevance across standard treatment segments. Reimbursement success remains high at approximately 85%, consistent with our expectations. Our commercial and medical teams continue to drive targeted provider education and payer engagement, supporting durable uptake and sustained market expansion. FYCOMPA delivered Q2 2025 net product revenue of $34.3 million, reflecting continued demand despite the first generic approval for tablets following loss of exclusivity in late May. As previously noted, we do expect revenue erosion from generic competition to impact FYCOMPA performance in the second half of the year and beyond. That said, based on a strong first-half performance in the execution of our mitigation strategies, we are reaffirming our full-year 2025 FYCOMPA revenue guidance. In summary, our commercial and medical teams continue to execute with discipline and focus, delivering strong portfolio performance while advancing the next wave of our growth, led by FIRDAPSE's expansion into oncology. We believe that we are well-positioned to seize the growth opportunities ahead, and we remain focused on driving commercial execution excellence, enhancing patient access, and scaling our commercial impact across our entire product portfolio. I want to thank the entire team at Catalyst for their unwavering commitment to the patients we serve and look forward to a successful second half of 2025. With that, I'll turn the call back over to Mike. Thank you, Jeff. Our performance during the second quarter of 2025 has kept us on pace for another strong year, driven by our solid financial performance, financial discipline, and strong execution. With the continued success of our flagship product, FIRDAPSE, as well as the strong growth of AGAMREE, which we launched in mid-March of 2024, and the solid performance of FYCOMPA, which currently has only one generic competitor for the tablets following patent expiry in May of 2025, we have set the groundwork for what promises to be yet another unparalleled year in 2025. We are reaffirming our 2025 full-year total revenue guidance as initially provided in February and reaffirmed in May. We remain steadfast in our commitment to driving growth and expanding our portfolio to capitalize on emerging opportunities throughout the year. Our total revenues for the second quarter of 2025 were $146.6 million and an approximate 19.4% increase when compared to total revenues of $122.7 million for the second quarter of 2024. Product revenue net for our lead product, FIRDAPSE, was $84.8 million, a 9.7% increase year-over -year compared to $77.4 million. As a reminder, the second quarter of 2024 benefited from the Change Healthcare Cybersecurity Incident that occurred in the first quarter of 2024, which is evidenced by the fact that our growth in net product revenue for FIRDAPSE for the first half of 2025 compared to the first half of 2024 was 16.9%. Product revenue net for the second quarter of 2025 for FYCOMPA was $34.3 million compared to $36.5 million in the second quarter of 2024. Product revenue net in the second quarter of 2025 for AGAMREE was $27.4 million as compared to $8.7 million in the second quarter of 2024, representing a year-over-year increase of approximately 213%. Net income before income taxes for the second quarter of 2025 was $69.3 million, a 24.2% increase year-over-year compared to $55.8 million for the second quarter of 2024. We reported GAAP net income for the second quarter of 2025 of $52.1 million or $0.41 per diluted share. GAAP net income increased by 27.7% year-over-year compared to GAAP net income for the second quarter of 2024 of $40.8 million or $0.33 per diluted share. Non-GAAP net income for the second quarter of 2025 was $86.4 million or $0.68 per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FYCOMPA, AGAMREE, and Ruzurgi of $9.3 million, stock-based compensation expense of $7.6 million, income tax provision of $17.2 million, and depreciation of $100,000. This compares to non-GAAP net income for the second quarter of 2024 of $69.6 million or $0.56 per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FYCOMPA, AGAMREE, and Ruzurgi of $9.3 million, stock-based compensation expense of $4.4 million, the income tax provision of $15.0 million, and depreciation of $100,000. Our year-to-date effective income tax rate through the first half of 2025 was 22.6% compared to 24.5% through the first half of 2024. The effective tax rate is affected by many factors, including the number of stock options exercised in any given period and is likely to fluctuate in future periods. Cost of sales expense was approximately $20.6 million in the second quarter of 2025 compared to $15.4 million in the second quarter of 2024 and consisted principally of royalties. As a reminder, AGAMREE royalties paid to the product licensor equal 5% of net sales up to $100 million, 7% of net sales in excess of $100 million, and up to $200 million, with additional increases as net sales increase beyond $200 million. The company is also required to make a $12.5 million sales-based milestone payment once AGAMREE's net product revenue reaches $100 million. This milestone payment, when earned, will be capitalized and amortized over the estimated remaining useful life of the asset. For further details on our royalty obligations for AGAMREE, are disclosed in our Q2 2025 Form 10-Q. Research and development expenses were $4.4 million in the second quarter of 2025, up 46% from $3.0 million in the second quarter of 2024. Our R&D spending in the second quarter of 2025 was comprised mainly of costs to support our ongoing AGAMREE studies. Selling, general and administrative or SG&A expenses for the second quarter of 2025 totaled $45.9 million compared to $40.7 million in the second quarter of 2024. The increase in SG&A expenses for the second quarter of 2025 was primarily driven by increased personnel costs, including the implementation of two dedicated sales forces for FIRDAPSE and AGAMREE, which became effective on April 1st, 2025. As reported, at June 30, 2025, we had cash and cash equivalents of $652.8 million compared to $517.6 million at December 31st, 2024. The increase in cash of $135.2 million was primarily driven by $131.3 million in cash generated from operations of the business, underscoring our continued focus on profit optimization and strong cash flow generation. We believe our current funds, along with our anticipated continued generation of cash from operations, continue to provide us with 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 second 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, August 6, 2025, and can be found on the Investor Relations page on our website. At this time, I will turn the call back over to Rich. Thanks, Mike. As we look ahead, Catalyst remains focused on and confident in our ability to drive sustained growth and long-term value. We are executing a clear strategy rooted in a strong commercial foundation. Our focus and execution will continue to drive our performance and enable us to deliver on our commitments while making a meaningful difference for patients. Our teams are energized by the opportunities ahead, and we remain committed to delivering differentiated therapies with operational excellence and responsible growth. Thank you to our Catalyst teams for their unwavering dedication to patients and to all of you for your continued support. We look forward to continuing to execute our growth initiatives as we advance into the second half of 2025. I'll now turn the call back over to the operator. Thank you. Thank you, Sam. Ladies and gentlemen, we will now be conducting a question and answer session. If you would like to ask a question, please press star, then one. The confirmation tone will indicate your line is in the question queue. You may press star and then two if you would like to remove your question from the queue. Again, if you would like to ask a question, please press star and then one now. The first question that we have comes from Samantha Simonico of Citibank. Please go ahead. Hi, good morning, and thanks very much for taking the questions. A couple first on FIRDAPSE. Can you speak more about your strategy for educating oncologists on the LEMS opportunity? I'm curious, what metrics are you using to track the success of the campaign? As you continue to focus on the oncology opportunity, when do you expect that segment of the business to begin representing a greater proportion of revenues versus historical experience? I believe in the past you said it's about 20% - 25% of revenues come from oncology patients. Thank you. Thanks, Samantha. I appreciate the question. I'm going to turn that to Jeff. Jeff, do you want to take it on? Sure. Hi, Sam. Good to hear from you. As we noted in the script, I think our approach to oncology in the addressable market there for cancer-associated LEMS, the first thing we really wanted to do was increase, provide frictionless testing for these patients. We were able to make that happen where oncologists and all HCPs could order our no-cost VGCC antibody test within their office. That shortened the time to the diagnostic. Secondly, the NCCN guideline changes. You heard that on July 25th, those changes happened. Those were the first two steps. Now we're working on working with the group practices and trying to put together some arrangements with them for screening. That's the third step. How are we going to educate these physicians? We're focused on digital marketing and media. We're also doing congresses and conferences and publication plans, working with our medical team on that to do abstracts as well. Those are the things that we're doing to help educate physicians about this important opportunity to diagnose LEMS patients. How we're going to track it is through increased VGCC antibody testing from oncologists. We're also tracking it, like you said, we anticipate an increase over time of our mix of patients that are cancer-associated LEMS patients. This year, our primary goal is to increase screening for cancer-associated LEMS patients. 90% of these patients are undiagnosed. If we can help these patients get diagnosed, then we anticipate a larger market that we should start seeing an increase in that percentage in 2026 and beyond. That's how we're looking at this, Sam. Thanks very much. That's super helpful. Just one follow-up for me. You mentioned on the prepared remarks that there's a phase I DMD switching study from prednisone or from deflazacort to AGAMREE. I'm wondering, how do you plan to leverage this data as you commercialize AGAMREE, or is it for additional studies that you're planning? Just any context you could share there would be very helpful. Thank you. Thanks, Sam. I'm going to turn that over to Will Andrews, our Chief Medical Officer. Obviously, we're looking at the, we'll be looking for the data, and I think a lot of that will determine how we leverage it. The study is ongoing, so I think it becomes a little challenging to answer your question directly. Will, do you want to take that? Thank you, Rich, and hello, Sam. The study is an exploratory trial. We are looking forward to seeing data later this year and early into 2026. That data will be descriptive and will help indicate whether we need to do future studies to further delineate potential switching, et cetera. Understood. Thanks very much for the question. Thank you, Sam. Thank you. Thank you. The next question we have comes from Joon Lee of Truist Securities. Please go ahead. Congrats on the quarter, and thanks for taking the questions. This is Asuman for Joon, just a couple from us. What impact are you seeing on FIRDAPSE and AGAMREE in uptake following the increase in sales force size that became effective on April 1st? As a follow-up on FIRDAPSE, just help us think about this growth over the next few quarters. Should we still be expecting a mid-teens growth rate on a year-over-year basis? Thank you. Thanks, Asha. I think, again, it's Jeff's going to answer that question, so thanks for the question. Jeff? Thanks for the question. Like you said, we deployed dedicated sales forces for both AGAMREE and FIRDAPSE in April, so beginning in the second quarter. What we've seen, it's still too early to tell, but based on performance, you can see that there are increased engagements that have taken place. We are also deeper relationships now within these accounts and also more frequent interactions with many of the healthcare providers and our targeted physicians. We're also seeing it from our leading indicators. As I mentioned on the call, with FIRDAPSE, we're meeting and exceeding the enrollments thus far in July. Very strong, and we also have a strong pipeline there. With AGAMREE too, we've seen the 231 unique physicians that have enrolled since launch. That also increased from the second quarter. Very, very satisfied with the results thus far, and we'll continue to track that moving forward. As far as performance for FIRDAPSE and what you should expect, we reiterated guidance for the balance of this year and also, like I just mentioned, the strong leading indicators. We do believe in our business and the foundation of our business for FIRDAPSE, so we expect continued growth. Thanks, Jeff. Thank you. Thank you. The next question we have comes from Jason Gerberry of Bank of America. Please go ahead. Hey guys, thanks for taking my questions. A couple for me. Just given all that's going on with a Elevidys in the, I guess, non-ambulatory group of patients and some of the commentary earlier in the year around queuing, I'm just kind of wondering how that impacts the quarterly kinetics of AGAMREE uptake, if at all. With FIRDAPSE, wondering if you could just maybe comment on sort of the time lag for the NCCN recommendation to have more of an impactful commercial impact. Thanks. Jason, thanks so much. From a commercial perspective, we'll take the Elevidys question. We'll turn it over to Jeff, and if there's more of a clinical, we'll have Will jump in on that. Jeff, you want to take that one first? Thanks for the question, Jason. With AGAMREE and steroids specifically, they are the foundation of treatment for these boys living with DMD. The impact of the unfortunate news about Elevidys really hasn't impacted much the use of steroids. We do strongly believe that AGAMREE is the steroid of choice. Will, do you want to jump in there on a clinical? Happy to, Rich. Thank you. We see the new additions to the NCCN guidelines as critical to helping for Elevidys. For DMD? Yes, I'm sorry. The second question was NCCN. Yes. On lElevidys, I would add medically that I agree with Jeff from the perspective of that being an entirely different modality of treatment. As Jeff said, it's unfortunate as to what's happened, but we still see, of course, corticosteroids and AGAMREE as foundational treatment for these kids that are unaffected, we believe, by what's happened with the Elevidys. To answer your second question on the NCCN guidelines, we see that as critical to helping educate oncologists, clinical oncologists on the disease, and very importantly, on how to better diagnose the disease. FIRDAPSE is a critical option for them in the treatment. I'll just add, the way we see the cadence working out, Jeff and the team have done a really good job of getting this frictionless testing in there, which we believe was the first step. The physician can order the test, and the report will come to their office. Prior to this, the patient had to actually go to a remote site, get a test, and then get the test results themselves. That's the first step. The NCCN guideline really is the bridge to care pathways within the practice. As we get this out there, and it was just released, obviously, last week, we get this out there, the opportunity then is to work through those oncology practices, get the NCCN guidelines embedded as the standard, and NCCN is the true standard within oncology, get that embedded, and then begin talking to the group practices about how they want to use it and how we can be supportive. As Jeff mentioned earlier, on an earlier question, those educational efforts working hand in hand with the GPOs and then beyond the GPOs as well become important. Jeff? Thanks, Rich. Jason, to your question, when do we expect this to hit commercial and increase some of the net revenue? The way we look at this, again, is increased screening this year, and then next year with more patients, thankfully, being diagnosed, the addressable market increases, and that can help with the treatment with FIRDAPSE. We expect that to take place probably in the second half of next year and beyond is when we start seeing converting some of these diagnosed patients onto FIRDAPSE therapy. Hopefully, that helps. Thanks, Jeff. Thank you. Thanks, Jason. Thank you. Ladies and gentlemen, just a reminder, if you would like to ask a question, please press star and then one. The next question we have comes from Leland Gershell of Oppenheimer & Co. Please go ahead. Oh, great. Good morning, and thanks for taking our questions. Just one from us, just on optics, maybe for Michael. Just wondering, you know, given the realignment in the sales for FIRDAPSE and AGAMREE affected a few months ago, just wondering how you see SG&A expense rolling forward. It looked like it was pretty flattish from Q1 to Q2. Just wondering if we should see a bit of a bump, you know, any increase into the second half. Thank you. Thanks, Leland. Hope all is well. As you know, we did not quantify SG&A guidance. We did talk qualitatively at the beginning of the year. Some of the folks that we had hired were in, obviously, a little before April 1. I think the flat is a little bit to what we'd expect. With the acceleration of the NCCN guidelines, I do think that we will see a little bit of an uptick in the second half. Okay, great. Thanks for taking the question. Thanks, Leland. Thank you. The next question we have comes from Luke Herrmann of Baird. Please go ahead. Hey guys, thanks for taking the question. Two from me. First, on the Change Health disruption, I was wondering if you could share your thoughts on whether all the loose ends have been closed here or if there's potential for any future anomalies. Second, recent language from the administration on pharma tariffs, which has obviously been sort of constantly evolving. I see that FIRDAPSE is manufactured in the U.S. and Canada, and I think you've had a process underway to consider the addition of third-party manufacturers for AGAMREE. I guess, has there been any recent evolution in thinking around the manufacturing strategy? Thanks, Luke. Thanks for the questions. The Change Healthcare issue, the disruption we saw there really was, as we mentioned in the script, really was a pull, sort of a push into the second quarter of 2024. We believe, and we see it, the natural cadence of FIRDAPSE returning post-June of 2024, and now we believe that effect is washed through the system. We're very confident about that because we can see, because of our specialty pharmacy relationship, we can see what's happening there at a very granular level. You may remember in our second first quarter call in May last year, we mentioned that we saw it the day it began to happen, so we were able to take rapid action. Having that specialty pharmacy is a real benefit for us. On the tariff side, you are correct. When you think about the volume of sales based on our guidance, about 66% of sales come from FIRDAPSE as it relates to our guidance for the year. We feel really well protected there. You are also correct on working with third-party manufacturers for AGAMREE and transitioning that to the U.S. We were working on that well before this current administration came into play. We're confident we'll be able to do that in the near term, but it's still going to take a while to actually validate the plan. We feel really good about the opportunity to shield that from tariffs as well in the mid to long term because of the ability to move it to the U.S. Great, thank you. Thanks, Luke. Thank you. The next question we have comes from Jennifer Kim of Cantor. Please go ahead. Hi, good morning. Thanks for taking my question. Maybe to start with FIRDAPSE, is there any color you can give around the average dose you've reached for the quarter and maybe expectations on that growth for the rest of the year? Anything you can say about discontinuation rates for the quarter? Jeff, do you want to take that? Sure, thanks, Rich. Yes, first I'll answer the discontinuation rates. Discontinuation rates were below 20%, the annual discontinuation rate of 20% for FIRDAPSE. Hopefully, were you asking about, Jennifer, were you asking about FIRDAPSE specifically on discontinuation? Yes. Okay, less than 20% annual discontinuation. What was your first question again? Dose. Since the label expansion in June of last year, we have seen a significant increase to the average daily dose, approximately about 4 milligrams, which is what we had expected. The dose is performing according to what we had expected. Okay, that's helpful. Maybe a question on FYCOMPA. I think right now, Teva is the only generic for the oral tablet that's launched. I just want to clarify, do they have a 100-day exclusivity? I ask because I wonder whether guidance could prove to be on the conservative side for that product. Teva is the only player in the space right now for a generic. They have a 180-day exclusivity. As to whether or not the guidance is too conservative, as we mentioned in the call, we've booked $70 million in sales. Our guidance is $90 million - $95 million. However, we think that there's an opportunity to be cautious here because this is a significant risk. If there is another generic player that could come into the market, and we have not seen them yet, we're taking what we believe is a prudent position for the balance of the year, and we will expect additional generic competitors by mid-December. As you know, Jennifer, sometimes they can load the channel into November. That could affect our X Factory sales. We believe this is a prudent approach to the forecast. Okay, that's helpful. All right, thanks, guys. Sure, thank you. Thank you. Ladies and gentlemen, just a final reminder. If you would like to ask a question, please press star and then one now. The next question we have comes from Sudan Loganathan of Stephens Inc. Please go ahead. Thanks. Good morning, Catalyst Pharmaceuticals team, and congrats on another strong quarter, and thank you for taking my questions. The first one, I want to ask how you view the potential for PTC's Translarna FDA approval for a DMD treatment to affect how AGAMREE will continue to fit in, retain market share, and continue to grow in this space. Secondly, what is your current stance on near-term strategic initiatives to offset FYCOMPA's LOE? Are there any ongoing discussions with potential partners regarding a commercial stage asset or a late-stage pipeline asset? I think appropriate to turn that to Jeff for the first part. Yeah, Sudan, just like similar to a Elevidys, you know, the way we look at this is AGAMREE and steroids are the balance of treatment. Translarna does not impact that at all. We just continue to feel strongly about AGAMREE's potential moving forward because we do believe it is the best and differentiated steroid out there for boys living with DMD. As far as. I'm sorry, Sudan, could you just repeat your question? I lost you for a second. Repeat the second question. Yeah, so the second one was just your current stance on the near-term strategic initiatives to offset the FYCOMPA LOE. If there's any ongoing discussions with either a commercial stage asset or a late-stage pipeline asset that you're kind of leaning towards in this market environment, or, you know, how you're viewing that going forward. Thanks for clarifying. On our business development front, as we look to offset, we think of our business in two elements, right? The business development front, bringing in new assets. We are incredibly busy. We believe this is probably one of the best buying environments we've seen in the last 15 or 20 years. Our team is assessing multiple opportunities at any point in time. As mentioned on previous calls, we continue to see 80% of the opportunities coming to us inbound. Other companies will approach us or other parties will approach us about opportunities. We're really excited about building, continuing to build a portfolio. In addition to that, a second pillar of our business is lifecycle management. When we talk about the opportunity around AGAMREE, looking for opportunities to better understand the molecule and how it might play in the orphan and rare space, we continue to do that work. On the commercial front, in diversifying our opportunities with FIRDAPSE, we believe the oncology play and the dedicated sales force can continue to work to offset the loss of FYCOMPA. I appreciate that. Thank you. Thank you. Thank you. Ladies and gentlemen, that then brings an end to our question and answer session. Thank you for joining today's conference. You may now disconnect your lines.

Speaker 8: Meetings. Welcome to the Catalyst Pharmaceuticals' second quarter 2025 financial results conference call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star then zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to the Chief Financial Officer, Mike Kalb. Please go ahead, sir. Meetings. meetings Welcome to the Catalyst Pharmaceuticals' second quarter 2025 financial results conference call. welcome to the catalyst pharmaceuticals' second quarter 2025 financial results conference call At this time, all participants are in listen-only mode. at this time all participants are in listen-only mode A question and answer session will follow the formal presentation. a question and answer session will follow the formal presentation If anyone should require operator assistance during the conference, please press star then zero on your telephone keypad. if anyone should require operator assistance during the conference please press star then zero on your telephone keypad As a reminder, this conference is being recorded. as a reminder this conference is being recorded I would now like to turn the conference over to the Chief Financial Officer, Mike Kalb. i would now like to turn the conference over to the chief financial officer mike kalb Please go ahead, sir. please go ahead sir

Speaker 11: Thank you. Good morning, everyone, and thank you for joining our conference call to discuss Catalyst Pharmaceuticals' second quarter 2025 financial results and business highlights. Richard Daly, President and CEO, will lead the call today, and Jeffrey Del Carmen, our Chief Commercial Officer, and I will also present. Additionally, Dr. Steven Miller, our Chief Operating Officer and Chief Scientific Officer, and Dr. Will Andrews, our Chief Medical Officer, will be available for the Q&A. Before we begin, I 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 reflect our current expectations, estimates, and projections, and do not guarantee future performance. They involve risks, uncertainties, and assumptions that are difficult to predict and may not prove to be accurate. Thank you. thank you Good morning, everyone, and thank you for joining our conference call to discuss Catalyst Pharmaceuticals' second quarter 2025 financial results and business highlights. good morning everyone and thank you for joining our conference call to discuss catalyst pharmaceuticals' second quarter 2025 financial results and business highlights Richard Daly, President and CEO, will lead the call today, and Jeffrey Del Carmen, our Chief Commercial Officer, and I will also present. richard daly president and ceo will lead the call today and jeffrey del carmen our chief commercial officer and i will also present Additionally, Dr. Steven Miller, our Chief Operating Officer and Chief Scientific Officer, and Dr. Will Andrews, our Chief Medical Officer, will be available for the Q&A. additionally dr steven miller our chief operating officer and chief scientific officer and dr will andrews our chief medical officer will be available for the q&a Before we begin, I 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. 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 reflect our current expectations, estimates, and projections, and do not guarantee future performance. these statements reflect our current expectations estimates and projections and do not guarantee future performance They involve risks, uncertainties, and assumptions that are difficult to predict and may not prove to be accurate. 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 our detailed information contained in our SEC filings, including the risk factors described in our 2024 annual report on Form 10-K filed with the SEC on February 26, 2025, and in our second quarter 2025 quarterly report on Form 10-Q, which was filed yesterday, August 6, 2025, with the SEC. At this time, I'll turn the call over to Rich. Rich? Actual results may vary from the expectations contained in our forward-looking statements. actual results may vary from the expectations contained in our forward-looking statements These forward-looking statements should be considered only in conjunction with our detailed information contained in our SEC filings, including the risk factors described in our 2024 annual report on Form 10-K filed with the SEC on February 26, 2025, and in our second quarter 2025 quarterly report on Form 10-Q, which was filed yesterday, August 6, 2025, with the SEC. these forward-looking statements should be considered only in conjunction with our detailed information contained in our sec filings including the risk factors described in our 2024 annual report on form 10-k filed with the sec on february 26 2025 and in our second quarter 2025 quarterly report on form 10-q which was filed yesterday august 6 2025 with the sec At this time, I'll turn the call over to Rich. at this time i'll turn the call over to rich Rich? rich

Speaker 5: Thanks, Mike. Good morning, everyone, and thank you for joining us. Catalyst delivered another record-setting quarter in Q2 2025, with total revenue reaching $146.6 million, an increase of 19.4% year-over-year. For the first half of 2025, total revenue grew 30.2% to $288 million, reflecting strong execution and sustained demand for our differentiated portfolio. We ended the second quarter of 2025 with a cash position of $652.8 million, reinforcing our ability to invest strategically for long-term growth. Based on strong leading indicators, we remain confident in our trajectory and believe that we are on track to achieve our full-year 2025 revenue guidance of $545 million - $565 million. Our outstanding progress is underpinned by the balanced performance of our commercial portfolio, which continues to deliver consistent growth and a positive impact on patients. Let's dive deeper and start with FIRDAPSE. Thanks, Mike. thanks mike Good morning, everyone, and thank you for joining us. good morning everyone and thank you for joining us Catalyst delivered another record-setting quarter in Q2 2025, with total revenue reaching $146.6 million, an increase of 19.4% year- over- year. catalyst delivered another record-setting quarter in q2 2025 with total revenue reaching $146.6 million an increase of 19.4% year- over- year For the first half of 2025, total revenue grew 30.2% to $288 million, reflecting strong execution and sustained demand for our differentiated portfolio. for the first half of 2025 total revenue grew 30.2% to $288 million reflecting strong execution and sustained demand for our differentiated portfolio We ended the second quarter of 2025 with a cash position of $652.8 million, reinforcing our ability to invest strategically for long-term growth. we ended the second quarter of 2025 with a cash position of $652.8 million reinforcing our ability to invest strategically for long-term growth Based on strong leading indicators, we remain confident in our trajectory and believe that we are on track to achieve our full-year 2025 revenue guidance of $545 million - $565 million. based on strong leading indicators we remain confident in our trajectory and believe that we are on track to achieve our full-year 2025 revenue guidance of $545 million - $565 million Our outstanding progress is underpinned by the balanced performance of our commercial portfolio, which continues to deliver consistent growth and a positive impact on patients. our outstanding progress is underpinned by the balanced performance of our commercial portfolio which continues to deliver consistent growth and a positive impact on patients Let's dive deeper and start with FIRDAPSE. let's dive deeper and start with firdapse FIRDAPSE generated net product revenue of $84.8 million in Q2 2025, a growth of $7.5 million versus Q2 2024. As we discussed in our Q1 2025 earnings call, last year's second quarter results reflect the timely impact of the February 2024 Change Healthcare Cybersecurity Breach on our year-over-year growth rate. The temporary impact of the Change Healthcare Security Breach, which shifted volume from Q1 2024 to Q2 2024, was fully resolved by the end of June 2024. As a result, we believe that comparing FIRDAPSE's first half 2025 performance to the same period in 2024 provides the most accurate view of the franchise's continued strength. Importantly, the underlying demand remains strong, consistent, and durable. Year to date, FIRDAPSE has delivered $168.6 million in net product revenue, representing a 16.9% increase over the first half of 2024. FIRDAPSE generated net product revenue of $84.8 million in Q2 2025, a growth of $7.5 million versus Q2 2024. firdapse generated net product revenue of $84.8 million in q2 2025 a growth of $7.5 million versus q2 2024 As we discussed in our Q1 2025 earnings call, last year's second quarter results reflect the timely impact of the February 2024 Change Healthcare Cybersecurity Breach on our year-over-year growth rate. as we discussed in our q1 2025 earnings call last year's second quarter results reflect the timely impact of the february 2024 change healthcare cybersecurity breach on our year-over-year growth rate The temporary impact of the Change Healthcare Security Breach, which shifted volume from Q1 2024 to Q2 2024, was fully resolved by the end of June 2024. the temporary impact of the change healthcare security breach which shifted volume from q1 2024 to q2 2024 was fully resolved by the end of june 2024 As a result, we believe that comparing FIRDAPSE's first half 2025 performance to the same period in 2024 provides the most accurate view of the franchise's continued strength. as a result we believe that comparing firdapse's first half 2025 performance to the same period in 2024 provides the most accurate view of the franchise's continued strength Importantly, the underlying demand remains strong, consistent, and durable. importantly the underlying demand remains strong consistent and durable Year to date, FIRDAPSE has delivered $168.6 million in net product revenue, representing a 16.9% increase over the first half of 2024. year to date firdapse has delivered $168.6 million in net product revenue representing a 16.9% increase over the first half of 2024 In 2025, our sales of FIRDAPSE have returned to their expected cadence, and we reaffirm our full-year 2025 net product revenue guidance of $355 million - $360 million. We are confident that FIRDAPSE remains well-positioned for sustained organic growth, supported by consistently high prescription approval rates and a robust pool of patients progressing through their diagnostic journey. This strong and visible demand underscores the durability of our franchise and reinforces our leadership in addressing the needs of the LEMS patient community. To unlock the next phase of growth for FIRDAPSE, we are actively advancing a focused expansion strategy centered on education of HCPs supported by the recent updated NCCN guidelines. Since we believe that potentially 90% of cancer-associated LEMS patients remain undiagnosed, we see a meaningful opportunity to expand our reach in this high-potential underserved population. In 2025, our sales of FIRDAPSE have returned to their expected cadence, and we reaffirm our full-year 2025 net product revenue guidance of $355 million - $360 million. in 2025 our sales of firdapse have returned to their expected cadence and we reaffirm our full-year 2025 net product revenue guidance of $355 million - $360 million We are confident that FIRDAPSE remains well-positioned for sustained organic growth, supported by consistently high prescription approval rates and a robust pool of patients progressing through their diagnostic journey. we are confident that firdapse remains well-positioned for sustained organic growth supported by consistently high prescription approval rates and a robust pool of patients progressing through their diagnostic journey This strong and visible demand underscores the durability of our franchise and reinforces our leadership in addressing the needs of the LEMS patient community. this strong and visible demand underscores the durability of our franchise and reinforces our leadership in addressing the needs of the lems patient community To unlock the next phase of growth for FIRDAPSE, we are actively advancing a focused expansion strategy centered on education of HCPs supported by the recent updated NCCN guidelines. to unlock the next phase of growth for firdapse we are actively advancing a focused expansion strategy centered on education of hcps supported by the recent updated nccn guidelines Since we believe that potentially 90% of cancer-associated LEMS patients remain undiagnosed, we see a meaningful opportunity to expand our reach in this high-potential underserved population. since we believe that potentially 90% of cancer-associated lems patients remain undiagnosed we see a meaningful opportunity to expand our reach in this high-potential underserved population We expect momentum to build in the months ahead, setting a stage for sustained growth in 2026 and beyond. Jeff will cover the specifics in his section of the call. While FIRDAPSE continues to perform well, we are equally encouraged by the accelerating adoption and performance of AGAMREE. AGAMREE continues to outperform expectations, generating $27.4 million in net product revenue in Q2 2025, a new post-launch high and a 213% increase year-over -year from Q2 2024. First half net revenues reached $49.4 million, up 398% from the prior year, driven by steady conversion from both prednisone and deflazacort, a strong 90% patient retention rate, and growing adoption across the Duchenne Centers of Excellence. AGAMREE's commercial execution is tracking well, with strong patient retention and increasing prescriber engagement, further supported by our full deployment of our dedicated field team. We expect momentum to build in the months ahead, setting a stage for sustained growth in 2026 and beyond. we expect momentum to build in the months ahead setting a stage for sustained growth in 2026 and beyond Jeff will cover the specifics in his section of the call. jeff will cover the specifics in his section of the call While FIRDAPSE continues to perform well, we are equally encouraged by the accelerating adoption and performance of AGAMREE. while firdapse continues to perform well we are equally encouraged by the accelerating adoption and performance of agamree AGAMREE continues to outperform expectations, generating $27.4 million in net product revenue in Q2 2025, a new post-launch high and a 213% increase year- over -year from Q2 2024. agamree continues to outperform expectations generating $27.4 million in net product revenue in q2 2025 a new post-launch high and a 213% increase year- over -year from q2 2024 First half net revenues reached $49.4 million, up 398% from the prior year, driven by steady conversion from both prednisone and deflazacort, a strong 90% patient retention rate, and growing adoption across the Duchenne Centers of Excellence. first half net revenues reached $49.4 million up 398% from the prior year driven by steady conversion from both prednisone and deflazacort a strong 90% patient retention rate and growing adoption across the duchenne centers of excellence AGAMREE's commercial execution is tracking well, with strong patient retention and increasing prescriber engagement, further supported by our full deployment of our dedicated field team. agamree's commercial execution is tracking well with strong patient retention and increasing prescriber engagement further supported by our full deployment of our dedicated field team Continued transitions from both branded and generic therapies, along with growing market receptivity and payer alignment, reinforce our confidence in meeting our full-year outlook. Backed by focused commercial strategy, AGAMREE is well-positioned to continue momentum. We are reaffirming AGAMREE's full-year 2025 net product revenue guidance of $100 million - $110 million. Let's switch to FYCOMPA. FYCOMPA delivered solid results in the second quarter of 2025, with revenue of $34.3 million, reflecting a year-over-year decrease of 6%. First half 2025 revenue reached $70 million, up 4.5% from the same period last year. We anticipate the impact of generic competition going forward, and our full-year net product revenue guidance of $90 million - $95 million for FYCOMPA remains unchanged. We recently strengthened our corporate and board leadership. I'd like to formally welcome Dr. Will Andrews as our new Chief Medical Officer. Will joined Catalyst on June 2nd, 2025. Continued transitions from both branded and generic therapies, along with growing market receptivity and payer alignment, reinforce our confidence in meeting our full-year outlook. continued transitions from both branded and generic therapies along with growing market receptivity and payer alignment reinforce our confidence in meeting our full-year outlook Backed by focused commercial strategy, AGAMREE is well-positioned to continue momentum. backed by focused commercial strategy agamree is well-positioned to continue momentum We are reaffirming AGAMREE's full-year 2025 net product revenue guidance of $100 million - $110 million. we are reaffirming agamree's full-year 2025 net product revenue guidance of $100 million - $110 million Let's switch to FYCOMPA. let's switch to fycompa FYCOMPA delivered solid results in the second quarter of 2025, with revenue of $34.3 million, reflecting a year-over-year decrease of 6%. fycompa delivered solid results in the second quarter of 2025 with revenue of $34.3 million reflecting a year-over-year decrease of 6% First half 2025 revenue reached $70 million, up 4.5% from the same period last year. first half 2025 revenue reached $70 million up 4.5% from the same period last year We anticipate the impact of generic competition going forward, and our full-year net product revenue guidance of $90 million - $95 million for FYCOMPA remains unchanged. we anticipate the impact of generic competition going forward and our full-year net product revenue guidance of $90 million - $95 million for fycompa remains unchanged We recently strengthened our corporate and board leadership. we recently strengthened our corporate and board leadership I'd like to formally welcome Dr. Will Andrews as our new Chief Medical Officer. i'd like to formally welcome dr will andrews as our new chief medical officer Will joined Catalyst on June 2nd, 2025. will joined catalyst on june 2nd 2025 Will brings deep pharmaceutical expertise in rare diseases, spanning clinical development, medical affairs, business development, and portfolio strategy. His leadership will ensure scientific rigor and operational excellence as we continue to differentiate AGAMREE within the Duchenne treatment landscape and further solidify our position in the LEMS community. Will's role in leading our medical function is foundational to ensuring the long-term success of our portfolio. For AGAMREE, Will is leading the Summit study, which aims to generate real-world evidence in support of the appropriate use of AGAMREE. To date, the study has initiated 19 sites, with patient enrollment progressing. As the study progresses, we will provide updates when the interim data becomes available. In parallel, Will is overseeing the execution of our phase I study, comparing AGAMREE, prednisone, and deflazacort to determine a potential switching algorithm. Will brings deep pharmaceutical expertise in rare diseases, spanning clinical development, medical affairs, business development, and portfolio strategy. will brings deep pharmaceutical expertise in rare diseases spanning clinical development medical affairs business development and portfolio strategy His leadership will ensure scientific rigor and operational excellence as we continue to differentiate AGAMREE within the Duchenne treatment landscape and further solidify our position in the LEMS community. his leadership will ensure scientific rigor and operational excellence as we continue to differentiate agamree within the duchenne treatment landscape and further solidify our position in the lems community Will's role in leading our medical function is foundational to ensuring the long-term success of our portfolio. will's role in leading our medical function is foundational to ensuring the long-term success of our portfolio For AGAMREE, Will is leading the Summit study, which aims to generate real-world evidence in support of the appropriate use of AGAMREE. for agamree will is leading the summit study which aims to generate real-world evidence in support of the appropriate use of agamree To date, the study has initiated 19 sites, with patient enrollment progressing. to date the study has initiated 19 sites with patient enrollment progressing As the study progresses, we will provide updates when the interim data becomes available. as the study progresses we will provide updates when the interim data becomes available In parallel, Will is overseeing the execution of our phase I study, comparing AGAMREE, prednisone, and deflazacort to determine a potential switching algorithm. in parallel will is overseeing the execution of our phase i study comparing agamree prednisone and deflazacort to determine a potential switching algorithm Additionally, we are working to assess the immunosuppressive effects of AGAMREE that could help us define the lifecycle management potential for AGAMREE. Initial results are expected by the end of 2025 to early 2026. Will's expertise and insights also enhance our strategic perspective as we advance growth initiatives aligned with our long-term vision. This past Monday, we announced that Dr. Dan Curran joined our Board of Directors. We are pleased to welcome Dr. Curran to our Board of Directors. He brings deep experience in rare disease and a strong track record in business development and strategic growth. His experience advancing transformative therapies and building value across the development continuum aligns well with our mission and growth strategy. Additionally, we are working to assess the immunosuppressive effects of AGAMREE that could help us define the lifecycle management potential for AGAMREE. additionally we are working to assess the immunosuppressive effects of agamree that could help us define the lifecycle management potential for agamree Initial results are expected by the end of 2025 to early 2026. initial results are expected by the end of 2025 to early 2026 Will's expertise and insights also enhance our strategic perspective as we advance growth initiatives aligned with our long-term vision. will's expertise and insights also enhance our strategic perspective as we advance growth initiatives aligned with our long-term vision This past Monday, we announced that Dr. Dan Curran joined our Board of Directors. this past monday we announced that dr dan curran joined our board of directors We are pleased to welcome Dr. Curran to our Board of Directors. we are pleased to welcome dr curran to our board of directors He brings deep experience in rare disease and a strong track record in business development and strategic growth. he brings deep experience in rare disease and a strong track record in business development and strategic growth His experience advancing transformative therapies and building value across the development continuum aligns well with our mission and growth strategy. his experience advancing transformative therapies and building value across the development continuum aligns well with our mission and growth strategy On the business development and IP front, we remain highly disciplined in employing our business development strategy, actively evaluating a broad range of opportunities that align both strategically and financially with our long-range plan. Our commitment to value-driven growth is unwavering, and we are confident that our focused and deliberate approach will position us to capitalize on the right opportunities. In parallel, we are advancing on our initiatives to protect and enhance the long-term value of our portfolio. We are still awaiting a trial date in our ongoing patent litigation for FIRDAPSE with our remaining first filers, but anticipate it to be in Q4 2025 or Q1 2026. We expect more clarity on this issue on or after our Markman hearing, which is scheduled for October 7th, 2025. We remain committed to updating our performance related to environmental, social, and governance reporting. On the business development and IP front, we remain highly disciplined in employing our business development strategy, actively evaluating a broad range of opportunities that align both strategically and financially with our long-range plan. on the business development and ip front we remain highly disciplined in employing our business development strategy actively evaluating a broad range of opportunities that align both strategically and financially with our long-range plan Our commitment to value-driven growth is unwavering, and we are confident that our focused and deliberate approach will position us to capitalize on the right opportunities. our commitment to value-driven growth is unwavering and we are confident that our focused and deliberate approach will position us to capitalize on the right opportunities In parallel, we are advancing on our initiatives to protect and enhance the long-term value of our portfolio. in parallel we are advancing on our initiatives to protect and enhance the long-term value of our portfolio We are still awaiting a trial date in our ongoing patent litigation for FIRDAPSE with our remaining first filers, but anticipate it to be in Q4 2025 or Q1 2026. we are still awaiting a trial date in our ongoing patent litigation for firdapse with our remaining first filers but anticipate it to be in q4 2025 or q1 2026 We expect more clarity on this issue on or after our Markman hearing, which is scheduled for October 7th, 2025. we expect more clarity on this issue on or after our markman hearing which is scheduled for october 7th 2025 We remain committed to updating our performance related to environmental, social, and governance reporting. we remain committed to updating our performance related to environmental social and governance reporting In June, we published our 2024 ESG report, underscoring our commitment to sustainable growth and responsible innovation. This report is available on the Catalyst website. In summary, we are entering the second half of 2025 with strong momentum, clearly defined growth drivers, and a focused strategy to deliver long-term value and impact for patients. With that, I'll turn it over to Jeff, who will provide additional insights into our commercial performance. In June, we published our 2024 ESG report, underscoring our commitment to sustainable growth and responsible innovation. in june we published our 2024 esg report underscoring our commitment to sustainable growth and responsible innovation This report is available on the Catalyst website. this report is available on the catalyst website In summary, we are entering the second half of 2025 with strong momentum, clearly defined growth drivers, and a focused strategy to deliver long-term value and impact for patients. in summary we are entering the second half of 2025 with strong momentum clearly defined growth drivers and a focused strategy to deliver long-term value and impact for patients With that, I'll turn it over to Jeff, who will provide additional insights into our commercial performance. with that i'll turn it over to jeff who will provide additional insights into our commercial performance

Speaker 10: Thanks, Rich. Q2 marked another record-setting quarter for our commercial organization, underscoring continued strong execution across the portfolio and sustained demand for our differentiated therapies. As Rich noted, Catalyst delivered sustained organic growth from FIRDAPSE, strong revenues from FYCOMPA, and accelerating adoption of AGAMREE. Q2 net product revenue of $146.5 million puts us firmly on track to meet our 2025 guidance, reflecting the strength of our neuroscience business. FIRDAPSE remains the only evidence-based FDA-approved treatment for Lambert-Eaton myasthenic syndrome. The brand continues to perform well across both neurology and our emerging oncology segments. FIRDAPSE continues its strong multi-quarter growth trajectory, driven by durable demand and consistent execution. Prescription approval rates remained above 90% across both government and commercial payers, and discontinuation rates were in line with expectations, tracking below an annualized rate of 20%. These indicators reflect strong patient adherence and reinforce the foundation for sustained performance. Thanks, Rich. thanks rich Q2 marked another record-setting quarter for our commercial organization, underscoring continued strong execution across the portfolio and sustained demand for our differentiated therapies. q2 marked another record-setting quarter for our commercial organization underscoring continued strong execution across the portfolio and sustained demand for our differentiated therapies As Rich noted, Catalyst delivered sustained organic growth from FIRDAPSE, strong revenues from FYCOMPA, and accelerating adoption of AGAMREE. as rich noted catalyst delivered sustained organic growth from firdapse strong revenues from fycompa and accelerating adoption of agamree Q2 net product revenue of $146.5 million puts us firmly on track to meet our 2025 guidance, reflecting the strength of our neuroscience business. q2 net product revenue of $146.5 million puts us firmly on track to meet our 2025 guidance reflecting the strength of our neuroscience business FIRDAPSE remains the only evidence-based FDA-approved treatment for Lambert-Eaton myasthenic syndrome. firdapse remains the only evidence-based fda-approved treatment for lambert-eaton myasthenic syndrome The brand continues to perform well across both neurology and our emerging oncology segments. the brand continues to perform well across both neurology and our emerging oncology segments FIRDAPSE continues its strong multi-quarter growth trajectory, driven by durable demand and consistent execution. firdapse continues its strong multi-quarter growth trajectory driven by durable demand and consistent execution Prescription approval rates remained above 90% across both government and commercial payers, and discontinuation rates were in line with expectations, tracking below an annualized rate of 20%. prescription approval rates remained above 90% across both government and commercial payers and discontinuation rates were in line with expectations tracking below an annualized rate of 20% These indicators reflect strong patient adherence and reinforce the foundation for sustained performance. these indicators reflect strong patient adherence and reinforce the foundation for sustained performance Leading indicators, including steady growth in new patient starts and refill volumes through July, continue to trend positively, reinforcing our confidence in achieving full-year 2025 FIRDAPSE revenue guidance. We continue to advance our patient identification efforts and continue to have a pool of over 500 LEMS patients in active diagnostic stages. These patients consistently account for approximately half of new starts each quarter, giving us confidence in driving sustained organic growth. To further unlock the next phase of growth for FIRDAPSE, we are actively advancing a focused expansion strategy centered on HCP education, which is supported by the recently updated NCCN guidelines for small cell lung cancer, broadening access to VGCC antibody testing, streamlining the diagnostic journey, and accelerating adoption across oncology and neurology settings. Leading indicators, including steady growth in new patient starts and refill volumes through July, continue to trend positively, reinforcing our confidence in achieving full-year 2025 FIRDAPSE revenue guidance. leading indicators including steady growth in new patient starts and refill volumes through july continue to trend positively reinforcing our confidence in achieving full-year 2025 firdapse revenue guidance We continue to advance our patient identification efforts and continue to have a pool of over 500 LEMS patients in active diagnostic stages. we continue to advance our patient identification efforts and continue to have a pool of over 500 lems patients in active diagnostic stages These patients consistently account for approximately half of new starts each quarter, giving us confidence in driving sustained organic growth. these patients consistently account for approximately half of new starts each quarter giving us confidence in driving sustained organic growth To further unlock the next phase of growth for FIRDAPSE, we are actively advancing a focused expansion strategy centered on HCP education, which is supported by the recently updated NCCN guidelines for small cell lung cancer, broadening access to VGCC antibody testing, streamlining the diagnostic journey, and accelerating adoption across oncology and neurology settings. to further unlock the next phase of growth for firdapse we are actively advancing a focused expansion strategy centered on hcp education which is supported by the recently updated nccn guidelines for small cell lung cancer broadening access to vgcc antibody testing streamlining the diagnostic journey and accelerating adoption across oncology and neurology settings By improving diagnosis, particularly in small cell lung cancer patients, and increasing recognition of patients often misdiagnosed with myasthenia gravis, we hope to meaningfully expand the addressable population and drive sustained growth within what we believe is a more than $1 billion addressable market opportunity. As we advance these priorities, we are implementing a three-step program of targeted initiatives designed to enhance diagnostic access and clinical recognition across key market segments. First, we are deploying a frictionless testing model that makes it easier for physicians and particularly oncologists to order VGCC antibody screening directly within their practices, eliminating referral delays and helping to significantly reduce time to diagnosis. These efforts represent progress in advancing important diagnostic initiatives to help improve LEMS patient outcomes and accelerate the adoption of FIRDAPSE. By improving diagnosis, particularly in small cell lung cancer patients, and increasing recognition of patients often misdiagnosed with myasthenia gravis, we hope to meaningfully expand the addressable population and drive sustained growth within what we believe is a more than $1 billion addressable market opportunity. by improving diagnosis particularly in small cell lung cancer patients and increasing recognition of patients often misdiagnosed with myasthenia gravis we hope to meaningfully expand the addressable population and drive sustained growth within what we believe is a more than $1 billion addressable market opportunity As we advance these priorities, we are implementing a three-step program of targeted initiatives designed to enhance diagnostic access and clinical recognition across key market segments. as we advance these priorities we are implementing a three-step program of targeted initiatives designed to enhance diagnostic access and clinical recognition across key market segments First, we are deploying a frictionless testing model that makes it easier for physicians and particularly oncologists to order VGCC antibody screening directly within their practices, eliminating referral delays and helping to significantly reduce time to diagnosis. first we are deploying a frictionless testing model that makes it easier for physicians and particularly oncologists to order vgcc antibody screening directly within their practices eliminating referral delays and helping to significantly reduce time to diagnosis These efforts represent progress in advancing important diagnostic initiatives to help improve LEMS patient outcomes and accelerate the adoption of FIRDAPSE. these efforts represent progress in advancing important diagnostic initiatives to help improve lems patient outcomes and accelerate the adoption of firdapse Second, we are pleased to share that ahead of schedule, the NCCN published updated guidelines for small cell lung cancer on July 25th, which now include VGCC antibody testing and recommend that amifampridine should be considered as a treatment for cancer patients with LEMS. This milestone strengthens our ability to expand access, accelerate diagnosis, and help drive FIRDAPSE adoption in oncology. Most importantly, it represents meaningful progress in improving care for cancer patients living with LEMS. Our third step involves forging strategic partnerships with leading oncology practices to update care pathways, which are generally structured plans that outline the steps and interventions required for patient care, ensuring standardized and efficient treatment for specific conditions. We plan to execute comprehensive education and promotion programs to ensure broad understanding and integration of the care pathways. Second, we are pleased to share that ahead of schedule, the NCCN published updated guidelines for small cell lung cancer on July 25th, which now include VGCC antibody testing and recommend that amifampridine should be considered as a treatment for cancer patients with LEMS. second we are pleased to share that ahead of schedule the nccn published updated guidelines for small cell lung cancer on july 25th which now include vgcc antibody testing and recommend that amifampridine should be considered as a treatment for cancer patients with lems This milestone strengthens our ability to expand access, accelerate diagnosis, and help drive FIRDAPSE adoption in oncology. this milestone strengthens our ability to expand access accelerate diagnosis and help drive firdapse adoption in oncology Most importantly, it represents meaningful progress in improving care for cancer patients living with LEMS. most importantly it represents meaningful progress in improving care for cancer patients living with lems Our third step involves forging strategic partnerships with leading oncology practices to update care pathways, which are generally structured plans that outline the steps and interventions required for patient care, ensuring standardized and efficient treatment for specific conditions. our third step involves forging strategic partnerships with leading oncology practices to update care pathways which are generally structured plans that outline the steps and interventions required for patient care ensuring standardized and efficient treatment for specific conditions We plan to execute comprehensive education and promotion programs to ensure broad understanding and integration of the care pathways. we plan to execute comprehensive education and promotion programs to ensure broad understanding and integration of the care pathways Due to the early updating of the NCCN guidelines, we are accelerating our investment in educating HCPs on the new guidelines and working to incorporate diagnostic and treatment recommendations into the care pathways in targeted large group oncology practices. Since we believe that potentially 90% of cancer-associated LEMS patients remain undiagnosed, we see a meaningful opportunity to expand our reach in this high-potential underserved population. We expect momentum to build in the months ahead, setting the stage for sustained growth in 2026 and beyond. Turning to AGAMREE, AGAMREE continues to demonstrate strong early market momentum as a differentiated treatment for Duchenne muscular dystrophy. Q2 2025 net product revenue was $27.4 million. Adoption continues to expand across key centers. To date, 93% of the top 45 DMD Centers of Excellence and 231 unique healthcare providers have submitted enrollment forms. Due to the early updating of the NCCN guidelines, we are accelerating our investment in educating HCPs on the new guidelines and working to incorporate diagnostic and treatment recommendations into the care pathways in targeted large group oncology practices. due to the early updating of the nccn guidelines we are accelerating our investment in educating hcps on the new guidelines and working to incorporate diagnostic and treatment recommendations into the care pathways in targeted large group oncology practices Since we believe that potentially 90% of cancer-associated LEMS patients remain undiagnosed, we see a meaningful opportunity to expand our reach in this high-potential underserved population. since we believe that potentially 90% of cancer-associated lems patients remain undiagnosed we see a meaningful opportunity to expand our reach in this high-potential underserved population We expect momentum to build in the months ahead, setting the stage for sustained growth in 2026 and beyond. we expect momentum to build in the months ahead setting the stage for sustained growth in 2026 and beyond Turning to AGAMREE, AGAMREE continues to demonstrate strong early market momentum as a differentiated treatment for Duchenne muscular dystrophy. turning to agamree agamree continues to demonstrate strong early market momentum as a differentiated treatment for duchenne muscular dystrophy Q2 2025 net product revenue was $27.4 million. q2 2025 net product revenue was $27.4 million Adoption continues to expand across key centers. adoption continues to expand across key centers To date, 93% of the top 45 DMD Centers of Excellence and 231 unique healthcare providers have submitted enrollment forms. to date 93% of the top 45 dmd centers of excellence and 231 unique healthcare providers have submitted enrollment forms In Q2, approximately 43% of patients transitioned from prednisone and 42% from deflazacort, underscoring AGAMREE's broad clinical relevance across standard treatment segments. Reimbursement success remains high at approximately 85%, consistent with our expectations. Our commercial and medical teams continue to drive targeted provider education and payer engagement, supporting durable uptake and sustained market expansion. FYCOMPA delivered Q2 2025 net product revenue of $34.3 million, reflecting continued demand despite the first generic approval for tablets following loss of exclusivity in late May. As previously noted, we do expect revenue erosion from generic competition to impact FYCOMPA performance in the second half of the year and beyond. That said, based on a strong first-half performance in the execution of our mitigation strategies, we are reaffirming our full-year 2025 FYCOMPA revenue guidance. In Q2, approximately 43% of patients transitioned from prednisone and 42% from deflazacort, underscoring AGAMREE's broad clinical relevance across standard treatment segments. in q2 approximately 43% of patients transitioned from prednisone and 42% from deflazacort underscoring agamree's broad clinical relevance across standard treatment segments Reimbursement success remains high at approximately 85%, consistent with our expectations. reimbursement success remains high at approximately 85% consistent with our expectations Our commercial and medical teams continue to drive targeted provider education and payer engagement, supporting durable uptake and sustained market expansion. our commercial and medical teams continue to drive targeted provider education and payer engagement supporting durable uptake and sustained market expansion FYCOMPA delivered Q2 2025 net product revenue of $34.3 million, reflecting continued demand despite the first generic approval for tablets following loss of exclusivity in late May. fycompa delivered q2 2025 net product revenue of $34.3 million reflecting continued demand despite the first generic approval for tablets following loss of exclusivity in late may As previously noted, we do expect revenue erosion from generic competition to impact FYCOMPA performance in the second half of the year and beyond. as previously noted we do expect revenue erosion from generic competition to impact fycompa performance in the second half of the year and beyond That said, based on a strong first-half performance in the execution of our mitigation strategies, we are reaffirming our full-year 2025 FYCOMPA revenue guidance. that said based on a strong first-half performance in the execution of our mitigation strategies we are reaffirming our full-year 2025 fycompa revenue guidance In summary, our commercial and medical teams continue to execute with discipline and focus, delivering strong portfolio performance while advancing the next wave of our growth, led by FIRDAPSE's expansion into oncology. We believe that we are well-positioned to seize the growth opportunities ahead, and we remain focused on driving commercial execution excellence, enhancing patient access, and scaling our commercial impact across our entire product portfolio. I want to thank the entire team at Catalyst for their unwavering commitment to the patients we serve and look forward to a successful second half of 2025. With that, I'll turn the call back over to Mike. In summary, our commercial and medical teams continue to execute with discipline and focus, delivering strong portfolio performance while advancing the next wave of our growth, led by FIRDAPSE's expansion into oncology. in summary our commercial and medical teams continue to execute with discipline and focus delivering strong portfolio performance while advancing the next wave of our growth led by firdapse's expansion into oncology We believe that we are well-positioned to seize the growth opportunities ahead, and we remain focused on driving commercial execution excellence, enhancing patient access, and scaling our commercial impact across our entire product portfolio. we believe that we are well-positioned to seize the growth opportunities ahead and we remain focused on driving commercial execution excellence enhancing patient access and scaling our commercial impact across our entire product portfolio I want to thank the entire team at Catalyst for their unwavering commitment to the patients we serve and look forward to a successful second half of 2025. i want to thank the entire team at catalyst for their unwavering commitment to the patients we serve and look forward to a successful second half of 2025 With that, I'll turn the call back over to Mike. with that i'll turn the call back over to mike

Speaker 11: Thank you, Jeff. Our performance during the second quarter of 2025 has kept us on pace for another strong year, driven by our solid financial performance, financial discipline, and strong execution. With the continued success of our flagship product, FIRDAPSE, as well as the strong growth of AGAMREE, which we launched in mid-March of 2024, and the solid performance of FYCOMPA, which currently has only one generic competitor for the tablets following patent expiry in May of 2025, we have set the groundwork for what promises to be yet another unparalleled year in 2025. We are reaffirming our 2025 full-year total revenue guidance as initially provided in February and reaffirmed in May. We remain steadfast in our commitment to driving growth and expanding our portfolio to capitalize on emerging opportunities throughout the year. Thank you, Jeff. thank you jeff Our performance during the second quarter of 2025 has kept us on pace for another strong year, driven by our solid financial performance, financial discipline, and strong execution. our performance during the second quarter of 2025 has kept us on pace for another strong year driven by our solid financial performance financial discipline and strong execution With the continued success of our flagship product, FIRDAPSE, as well as the strong growth of AGAMREE, which we launched in mid-March of 2024, and the solid performance of FYCOMPA, which currently has only one generic competitor for the tablets following patent expiry in May of 2025, we have set the groundwork for what promises to be yet another unparalleled year in 2025. with the continued success of our flagship product firdapse as well as the strong growth of agamree which we launched in mid-march of 2024 and the solid performance of fycompa which currently has only one generic competitor for the tablets following patent expiry in may of 2025 we have set the groundwork for what promises to be yet another unparalleled year in 2025 We are reaffirming our 2025 full-year total revenue guidance as initially provided in February and reaffirmed in May. we are reaffirming our 2025 full-year total revenue guidance as initially provided in february and reaffirmed in may We remain steadfast in our commitment to driving growth and expanding our portfolio to capitalize on emerging opportunities throughout the year. we remain steadfast in our commitment to driving growth and expanding our portfolio to capitalize on emerging opportunities throughout the year Our total revenues for the second quarter of 2025 were $146.6 million and an approximate 19.4% increase when compared to total revenues of $122.7 million for the second quarter of 2024. Product revenue net for our lead product, FIRDAPSE, was $84.8 million, a 9.7% increase year-over -year compared to $77.4 million. As a reminder, the second quarter of 2024 benefited from the Change Healthcare Cybersecurity Incident that occurred in the first quarter of 2024, which is evidenced by the fact that our growth in net product revenue for FIRDAPSE for the first half of 2025 compared to the first half of 2024 was 16.9%. Product revenue net for the second quarter of 2025 for FYCOMPA was $34.3 million compared to $36.5 million in the second quarter of 2024. Our total revenues for the second quarter of 2025 were $146.6 million and an approximate 19.4% increase when compared to total revenues of $122.7 million for the second quarter of 2024. our total revenues for the second quarter of 2025 were $146.6 million and an approximate 19.4% increase when compared to total revenues of $122.7 million for the second quarter of 2024 Product revenue net for our lead product, FIRDAPSE, was $84.8 million, a 9.7% increase year- over -year compared to $77.4 million. product revenue net for our lead product firdapse was $84.8 million a 9.7% increase year- over -year compared to $77.4 million As a reminder, the second quarter of 2024 benefited from the Change Healthcare Cybersecurity Incident that occurred in the first quarter of 2024, which is evidenced by the fact that our growth in net product revenue for FIRDAPSE for the first half of 2025 compared to the first half of 2024 was 16.9%. as a reminder the second quarter of 2024 benefited from the change healthcare cybersecurity incident that occurred in the first quarter of 2024 which is evidenced by the fact that our growth in net product revenue for firdapse for the first half of 2025 compared to the first half of 2024 was 16.9% Product revenue net for the second quarter of 2025 for FYCOMPA was $34.3 million compared to $36.5 million in the second quarter of 2024. product revenue net for the second quarter of 2025 for fycompa was $34.3 million compared to $36.5 million in the second quarter of 2024 Product revenue net in the second quarter of 2025 for AGAMREE was $27.4 million as compared to $8.7 million in the second quarter of 2024, representing a year-over-year increase of approximately 213%. Net income before income taxes for the second quarter of 2025 was $69.3 million, a 24.2% increase year-over-year compared to $55.8 million for the second quarter of 2024. We reported GAAP net income for the second quarter of 2025 of $52.1 million or $0.41 per diluted share. GAAP net income increased by 27.7% year-over-year compared to GAAP net income for the second quarter of 2024 of $40.8 million or $0.33 per diluted share. Product revenue net in the second quarter of 2025 for AGAMREE was $27.4 million as compared to $8.7 million in the second quarter of 2024, representing a year-over-year increase of approximately 213%. product revenue net in the second quarter of 2025 for agamree was $27.4 million as compared to $8.7 million in the second quarter of 2024 representing a year-over-year increase of approximately 213% Net income before income taxes for the second quarter of 2025 was $69.3 million, a 24.2% increase year- over- year compared to $55.8 million for the second quarter of 2024. net income before income taxes for the second quarter of 2025 was $69.3 million a 24.2% increase year- over- year compared to $55.8 million for the second quarter of 2024 We reported GAAP net income for the second quarter of 2025 of $52.1 million or $0.41 per diluted share. we reported gaap net income for the second quarter of 2025 of $52.1 million or $0.41 per diluted share GAAP net income increased by 27.7% year- over- year compared to GAAP net income for the second quarter of 2024 of $40.8 million or $0.33 per diluted share. gaap net income increased by 27.7% year- over- year compared to gaap net income for the second quarter of 2024 of $40.8 million or $0.33 per diluted share Non-GAAP net income for the second quarter of 2025 was $86.4 million or $0.68 per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FYCOMPA, AGAMREE, and Ruzurgi of $9.3 million, stock-based compensation expense of $7.6 million, income tax provision of $17.2 million, and depreciation of $100,000. This compares to non-GAAP net income for the second quarter of 2024 of $69.6 million or $0.56 per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FYCOMPA, AGAMREE, and Ruzurgi of $9.3 million, stock-based compensation expense of $4.4 million, the income tax provision of $15.0 million, and depreciation of $100,000. Our year-to-date effective income tax rate through the first half of 2025 was 22.6% compared to 24.5% through the first half of 2024. Non-GAAP net income for the second quarter of 2025 was $86.4 million or $0.68 per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FYCOMPA, AGAMREE, and Ruzurgi of $9.3 million, stock-based compensation expense of $7.6 million, income tax provision of $17.2 million, and depreciation of $100,000. non-gaap net income for the second quarter of 2025 was $86.4 million or $0.68 per diluted share which excludes from gaap net income amortization of intangible assets related to our acquisitions of fycompa agamree and ruzurgi of $9.3 million stock-based compensation expense of $7.6 million income tax provision of $17.2 million and depreciation of $100,000 This compares to non-GAAP net income for the second quarter of 2024 of $69.6 million or $0.56 per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FYCOMPA, AGAMREE, and Ruzurgi of $9.3 million, stock-based compensation expense of $4.4 million, the income tax provision of $15.0 million, and depreciation of $100,000. this compares to non-gaap net income for the second quarter of 2024 of $69.6 million or $0.56 per diluted share which excludes from gaap net income amortization of intangible assets related to our acquisitions of fycompa agamree and ruzurgi of $9.3 million stock-based compensation expense of $4.4 million the income tax provision of $15.0 million and depreciation of $100,000 Our year-to-date effective income tax rate through the first half of 2025 was 22.6% compared to 24.5% through the first half of 2024. our year-to-date effective income tax rate through the first half of 2025 was 22.6% compared to 24.5% through the first half of 2024 The effective tax rate is affected by many factors, including the number of stock options exercised in any given period and is likely to fluctuate in future periods. Cost of sales expense was approximately $20.6 million in the second quarter of 2025 compared to $15.4 million in the second quarter of 2024 and consisted principally of royalties. As a reminder, AGAMREE royalties paid to the product licensor equal 5% of net sales up to $100 million, 7% of net sales in excess of $100 million, and up to $200 million, with additional increases as net sales increase beyond $200 million. The company is also required to make a $12.5 million sales-based milestone payment once AGAMREE's net product revenue reaches $100 million. This milestone payment, when earned, will be capitalized and amortized over the estimated remaining useful life of the asset. 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. the effective tax rate is affected by many factors including the number of stock options exercised in any given period and is likely to fluctuate in future periods Cost of sales expense was approximately $20.6 million in the second quarter of 2025 compared to $15.4 million in the second quarter of 2024 and consisted principally of royalties. cost of sales expense was approximately $20.6 million in the second quarter of 2025 compared to $15.4 million in the second quarter of 2024 and consisted principally of royalties As a reminder, AGAMREE royalties paid to the product licensor equal 5% of net sales up to $100 million, 7% of net sales in excess of $100 million, and up to $200 million, with additional increases as net sales increase beyond $200 million. as a reminder agamree royalties paid to the product licensor equal 5% of net sales up to $100 million 7% of net sales in excess of $100 million and up to $200 million with additional increases as net sales increase beyond $200 million The company is also required to make a $12.5 million sales-based milestone payment once AGAMREE's net product revenue reaches $100 million. the company is also required to make a $12.5 million sales-based milestone payment once agamree's net product revenue reaches $100 million This milestone payment, when earned, will be capitalized and amortized over the estimated remaining useful life of the asset. this milestone payment when earned will be capitalized and amortized over the estimated remaining useful life of the asset For further details on our royalty obligations for AGAMREE, are disclosed in our Q2 2025 Form 10-Q. Research and development expenses were $4.4 million in the second quarter of 2025, up 46% from $3.0 million in the second quarter of 2024. Our R&D spending in the second quarter of 2025 was comprised mainly of costs to support our ongoing AGAMREE studies. Selling, general and administrative or SG&A expenses for the second quarter of 2025 totaled $45.9 million compared to $40.7 million in the second quarter of 2024. The increase in SG&A expenses for the second quarter of 2025 was primarily driven by increased personnel costs, including the implementation of two dedicated sales forces for FIRDAPSE and AGAMREE, which became effective on April 1st, 2025. As reported, at June 30, 2025, we had cash and cash equivalents of $652.8 million compared to $517.6 million at December 31st, 2024. For further details on our royalty obligations for AGAMREE, are disclosed in our Q2 2025 Form 10-Q. for further details on our royalty obligations for agamree are disclosed in our q2 2025 form 10-q Research and development expenses were $4.4 million in the second quarter of 2025, up 46% from $3.0 million in the second quarter of 2024. research and development expenses were $4.4 million in the second quarter of 2025 up 46% from $3.0 million in the second quarter of 2024 Our R&D spending in the second quarter of 2025 was comprised mainly of costs to support our ongoing AGAMREE studies. our r&d spending in the second quarter of 2025 was comprised mainly of costs to support our ongoing agamree studies Selling, general and administrative or SG&A expenses for the second quarter of 2025 totaled $45.9 million compared to $40.7 million in the second quarter of 2024. selling general and administrative or sg&a expenses for the second quarter of 2025 totaled $45.9 million compared to $40.7 million in the second quarter of 2024 The increase in SG&A expenses for the second quarter of 2025 was primarily driven by increased personnel costs, including the implementation of two dedicated sales forces for FIRDAPSE and AGAMREE, which became effective on April 1st, 2025. the increase in sg&a expenses for the second quarter of 2025 was primarily driven by increased personnel costs including the implementation of two dedicated sales forces for firdapse and agamree which became effective on april 1st 2025 As reported, at June 30, 2025, we had cash and cash equivalents of $652.8 million compared to $517.6 million at December 31st, 2024. as reported at june 30 2025 we had cash and cash equivalents of $652.8 million compared to $517.6 million at december 31st 2024 The increase in cash of $135.2 million was primarily driven by $131.3 million in cash generated from operations of the business, underscoring our continued focus on profit optimization and strong cash flow generation. We believe our current funds, along with our anticipated continued generation of cash from operations, continue to provide us with 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 second 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, August 6, 2025, and can be found on the Investor Relations page on our website. At this time, I will turn the call back over to Rich. The increase in cash of $135.2 million was primarily driven by $131.3 million in cash generated from operations of the business, underscoring our continued focus on profit optimization and strong cash flow generation. the increase in cash of $135.2 million was primarily driven by $131.3 million in cash generated from operations of the business underscoring our continued focus on profit optimization and strong cash flow generation We believe our current funds, along with our anticipated continued generation of cash from operations, continue to provide us with 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. we believe our current funds along with our anticipated continued generation of cash from operations continue to provide us with 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 second 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, August 6, 2025, and can be found on the Investor Relations page on our website. more detailed information and analysis of our second 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 august 6 2025 and can be found on the investor relations page on our website At this time, I will turn the call back over to Rich. at this time i will turn the call back over to rich

Speaker 5: Thanks, Mike. As we look ahead, Catalyst remains focused on and confident in our ability to drive sustained growth and long-term value. We are executing a clear strategy rooted in a strong commercial foundation. Our focus and execution will continue to drive our performance and enable us to deliver on our commitments while making a meaningful difference for patients. Our teams are energized by the opportunities ahead, and we remain committed to delivering differentiated therapies with operational excellence and responsible growth. Thank you to our Catalyst teams for their unwavering dedication to patients and to all of you for your continued support. We look forward to continuing to execute our growth initiatives as we advance into the second half of 2025. I'll now turn the call back over to the operator. Thank you. Thanks, Mike. thanks mike As we look ahead, Catalyst remains focused on and confident in our ability to drive sustained growth and long-term value. as we look ahead catalyst remains focused on and confident in our ability to drive sustained growth and long-term value We are executing a clear strategy rooted in a strong commercial foundation. we are executing a clear strategy rooted in a strong commercial foundation Our focus and execution will continue to drive our performance and enable us to deliver on our commitments while making a meaningful difference for patients. our focus and execution will continue to drive our performance and enable us to deliver on our commitments while making a meaningful difference for patients Our teams are energized by the opportunities ahead, and we remain committed to delivering differentiated therapies with operational excellence and responsible growth. our teams are energized by the opportunities ahead and we remain committed to delivering differentiated therapies with operational excellence and responsible growth Thank you to our Catalyst teams for their unwavering dedication to patients and to all of you for your continued support. thank you to our catalyst teams for their unwavering dedication to patients and to all of you for your continued support We look forward to continuing to execute our growth initiatives as we advance into the second half of 2025. we look forward to continuing to execute our growth initiatives as we advance into the second half of 2025 I'll now turn the call back over to the operator. i'll now turn the call back over to the operator Thank you. thank you

Speaker 8: Thank you, Sam. Ladies and gentlemen, we will now be conducting a question and answer session. If you would like to ask a question, please press star, then one. The confirmation tone will indicate your line is in the question queue. You may press star and then two if you would like to remove your question from the queue. Again, if you would like to ask a question, please press star and then one now. The first question that we have comes from Samantha Simonico of Citibank. Please go ahead. Thank you, Sam. thank you sam Ladies and gentlemen, we will now be conducting a question and answer session. ladies and gentlemen we will now be conducting a question and answer session If you would like to ask a question, please press star, then one. if you would like to ask a question please press star then one The confirmation tone will indicate your line is in the question queue. the confirmation tone will indicate your line is in the question queue You may press star and then two if you would like to remove your question from the queue. you may press star and then two if you would like to remove your question from the queue Again, if you would like to ask a question, please press star and then one now. The first question that we have comes from Samantha Simonico of Citibank. again if you would like to ask a question please press star and then one now. the first question that we have comes from samantha simonico of citibank Please go ahead. please go ahead Hi, good morning, and thanks very much for taking the questions. A couple first on FIRDAPSE. Can you speak more about your strategy for educating oncologists on the LEMS opportunity? I'm curious, what metrics are you using to track the success of the campaign? As you continue to focus on the oncology opportunity, when do you expect that segment of the business to begin representing a greater proportion of revenues versus historical experience? I believe in the past you said it's about 20% - 25% of revenues come from oncology patients. Thank you. Hi, good morning, and thanks very much for taking the questions. hi good morning and thanks very much for taking the questions A couple first on FIRDAPSE. a couple first on firdapse Can you speak more about your strategy for educating oncologists on the LEMS opportunity? can you speak more about your strategy for educating oncologists on the lems opportunity I'm curious, what metrics are you using to track the success of the campaign? i'm curious what metrics are you using to track the success of the campaign As you continue to focus on the oncology opportunity, when do you expect that segment of the business to begin representing a greater proportion of revenues versus historical experience? as you continue to focus on the oncology opportunity when do you expect that segment of the business to begin representing a greater proportion of revenues versus historical experience I believe in the past you said it's about 20% - 25% of revenues come from oncology patients. i believe in the past you said it's about 20% - 25% of revenues come from oncology patients Thank you. thank you

Speaker 5: Thanks, Samantha. I appreciate the question. I'm going to turn that to Jeff. Jeff, do you want to take it on? Thanks, Samantha. thanks samantha I appreciate the question. i appreciate the question I'm going to turn that to Jeff. i'm going to turn that to jeff Jeff, do you want to take it on? jeff do you want to take it on

Speaker 10: Sure. Hi, Sam. Good to hear from you. As we noted in the script, I think our approach to oncology in the addressable market there for cancer-associated LEMS, the first thing we really wanted to do was increase, provide frictionless testing for these patients. We were able to make that happen where oncologists and all HCPs could order our no-cost VGCC antibody test within their office. That shortened the time to the diagnostic. Secondly, the NCCN guideline changes. You heard that on July 25th, those changes happened. Those were the first two steps. Now we're working on working with the group practices and trying to put together some arrangements with them for screening. That's the third step. How are we going to educate these physicians? We're focused on digital marketing and media. Sure. sure Hi, Sam. hi sam Good to hear from you. good to hear from you As we noted in the script, I think our approach to oncology in the addressable market there for cancer-associated LEMS, the first thing we really wanted to do was increase, provide frictionless testing for these patients. as we noted in the script i think our approach to oncology in the addressable market there for cancer-associated lems the first thing we really wanted to do was increase provide frictionless testing for these patients We were able to make that happen where oncologists and all HCPs could order our no-cost VGCC antibody test within their office. we were able to make that happen where oncologists and all hcps could order our no-cost vgcc antibody test within their office That shortened the time to the diagnostic. that shortened the time to the diagnostic Secondly, the NCCN guideline changes. secondly the nccn guideline changes You heard that on July 25th, those changes happened. you heard that on july 25th those changes happened Those were the first two steps. those were the first two steps Now we're working on working with the group practices and trying to put together some arrangements with them for screening. now we're working on working with the group practices and trying to put together some arrangements with them for screening That's the third step. that's the third step How are we going to educate these physicians? how are we going to educate these physicians We're focused on digital marketing and media. we're focused on digital marketing and media We're also doing congresses and conferences and publication plans, working with our medical team on that to do abstracts as well. Those are the things that we're doing to help educate physicians about this important opportunity to diagnose LEMS patients. How we're going to track it is through increased VGCC antibody testing from oncologists. We're also tracking it, like you said, we anticipate an increase over time of our mix of patients that are cancer-associated LEMS patients. This year, our primary goal is to increase screening for cancer-associated LEMS patients. 90% of these patients are undiagnosed. If we can help these patients get diagnosed, then we anticipate a larger market that we should start seeing an increase in that percentage in 2026 and beyond. That's how we're looking at this, Sam. We're also doing congresses and conferences and publication plans, working with our medical team on that to do abstracts as well. we're also doing congresses and conferences and publication plans working with our medical team on that to do abstracts as well Those are the things that we're doing to help educate physicians about this important opportunity to diagnose LEMS patients. those are the things that we're doing to help educate physicians about this important opportunity to diagnose lems patients How we're going to track it is through increased VGCC antibody testing from oncologists. how we're going to track it is through increased vgcc antibody testing from oncologists We're also tracking it, like you said, we anticipate an increase over time of our mix of patients that are cancer-associated LEMS patients. we're also tracking it like you said we anticipate an increase over time of our mix of patients that are cancer-associated lems patients This year, our primary goal is to increase screening for cancer-associated LEMS patients. 90% of these patients are undiagnosed. this year our primary goal is to increase screening for cancer-associated lems patients 90% of these patients are undiagnosed If we can help these patients get diagnosed, then we anticipate a larger market that we should start seeing an increase in that percentage in 2026 and beyond. if we can help these patients get diagnosed then we anticipate a larger market that we should start seeing an increase in that percentage in 2026 and beyond That's how we're looking at this, Sam. that's how we're looking at this sam Thanks very much. That's super helpful. Just one follow-up for me. You mentioned on the prepared remarks that there's a phase I DMD switching study from prednisone or from deflazacort to AGAMREE. I'm wondering, how do you plan to leverage this data as you commercialize AGAMREE, or is it for additional studies that you're planning? Just any context you could share there would be very helpful. Thank you. Thanks very much. thanks very much That's super helpful. that's super helpful Just one follow-up for me. just one follow-up for me You mentioned on the prepared remarks that there's a phase I DMD switching study from prednisone or from deflazacort to AGAMREE. you mentioned on the prepared remarks that there's a phase i dmd switching study from prednisone or from deflazacort to agamree I'm wondering, how do you plan to leverage this data as you commercialize AGAMREE, or is it for additional studies that you're planning? i'm wondering how do you plan to leverage this data as you commercialize agamree or is it for additional studies that you're planning Just any context you could share there would be very helpful. just any context you could share there would be very helpful Thank you. thank you

Speaker 5: Thanks, Sam. I'm going to turn that over to Will Andrews, our Chief Medical Officer. Obviously, we're looking at the, we'll be looking for the data, and I think a lot of that will determine how we leverage it. The study is ongoing, so I think it becomes a little challenging to answer your question directly. Will, do you want to take that? Thanks, Sam. thanks sam I'm going to turn that over to Will Andrews, our Chief Medical Officer. i'm going to turn that over to will andrews our chief medical officer Obviously, we're looking at the, we'll be looking for the data, and I think a lot of that will determine how we leverage it. obviously we're looking at the we'll be looking for the data and i think a lot of that will determine how we leverage it The study is ongoing, so I think it becomes a little challenging to answer your question directly. the study is ongoing so i think it becomes a little challenging to answer your question directly Will, do you want to take that? will do you want to take that

Speaker 3: Thank you, Rich, and hello, Sam. The study is an exploratory trial. We are looking forward to seeing data later this year and early into 2026. That data will be descriptive and will help indicate whether we need to do future studies to further delineate potential switching, et cetera. Thank you, Rich, and hello, Sam. thank you rich and hello sam The study is an exploratory trial. the study is an exploratory trial We are looking forward to seeing data later this year and early into 2026. we are looking forward to seeing data later this year and early into 2026 That data will be descriptive and will help indicate whether we need to do future studies to further delineate potential switching, et cetera. that data will be descriptive and will help indicate whether we need to do future studies to further delineate potential switching et cetera Understood. Thanks very much for the question. Understood. understood Thanks very much for the question. thanks very much for the question

Speaker 5: Thank you, Sam. Thank you, Sam. thank you sam

Speaker 8: Thank you. Thank you. The next question we have comes from Joon Lee of Truist Securities. Please go ahead. Thank you. thank you Thank you. thank you The next question we have comes from Joon Lee of Truist Securities. the next question we have comes from joon lee of truist securities Please go ahead. please go ahead Congrats on the quarter, and thanks for taking the questions. This is Asuman for Joon, just a couple from us. What impact are you seeing on FIRDAPSE and AGAMREE in uptake following the increase in sales force size that became effective on April 1st? As a follow-up on FIRDAPSE, just help us think about this growth over the next few quarters. Should we still be expecting a mid-teens growth rate on a year-over-year basis? Thank you. Congrats on the quarter, and thanks for taking the questions. congrats on the quarter and thanks for taking the questions This is Asuman for Joon, just a couple from us. this is asuman for joon just a couple from us What impact are you seeing on FIRDAPSE and AGAMREE in uptake following the increase in sales force size that became effective on April 1st? what impact are you seeing on firdapse and agamree in uptake following the increase in sales force size that became effective on april 1st As a follow-up on FIRDAPSE, just help us think about this growth over the next few quarters. as a follow-up on firdapse just help us think about this growth over the next few quarters Should we still be expecting a mid-teens growth rate on a year-over-year basis? should we still be expecting a mid-teens growth rate on a year-over-year basis Thank you. thank you

Speaker 5: Thanks, Asha. I think, again, it's Jeff's going to answer that question, so thanks for the question. Jeff? Thanks, Asha. thanks asha I think, again, it's Jeff's going to answer that question, so thanks for the question. i think again it's jeff's going to answer that question so thanks for the question Jeff? jeff

Speaker 10: Thanks for the question. Like you said, we deployed dedicated sales forces for both AGAMREE and FIRDAPSE in April, so beginning in the second quarter. What we've seen, it's still too early to tell, but based on performance, you can see that there are increased engagements that have taken place. We are also deeper relationships now within these accounts and also more frequent interactions with many of the healthcare providers and our targeted physicians. We're also seeing it from our leading indicators. As I mentioned on the call, with FIRDAPSE, we're meeting and exceeding the enrollments thus far in July. Very strong, and we also have a strong pipeline there. With AGAMREE too, we've seen the 231 unique physicians that have enrolled since launch. That also increased from the second quarter. Very, very satisfied with the results thus far, and we'll continue to track that moving forward. Thanks for the question. thanks for the question Like you said, we deployed dedicated sales forces for both AGAMREE and FIRDAPSE in April, so beginning in the second quarter. like you said we deployed dedicated sales forces for both agamree and firdapse in april so beginning in the second quarter What we've seen, it's still too early to tell, but based on performance, you can see that there are increased engagements that have taken place. what we've seen it's still too early to tell but based on performance you can see that there are increased engagements that have taken place We are also deeper relationships now within these accounts and also more frequent interactions with many of the healthcare providers and our targeted physicians. we are also deeper relationships now within these accounts and also more frequent interactions with many of the healthcare providers and our targeted physicians We're also seeing it from our leading indicators. we're also seeing it from our leading indicators As I mentioned on the call, with FIRDAPSE, we're meeting and exceeding the enrollments thus far in July. as i mentioned on the call with firdapse we're meeting and exceeding the enrollments thus far in july Very strong, and we also have a strong pipeline there. very strong and we also have a strong pipeline there With AGAMREE too, we've seen the 231 unique physicians that have enrolled since launch. with agamree too we've seen the 231 unique physicians that have enrolled since launch That also increased from the second quarter. that also increased from the second quarter Very, very satisfied with the results thus far, and we'll continue to track that moving forward. very very satisfied with the results thus far and we'll continue to track that moving forward As far as performance for FIRDAPSE and what you should expect, we reiterated guidance for the balance of this year and also, like I just mentioned, the strong leading indicators. We do believe in our business and the foundation of our business for FIRDAPSE, so we expect continued growth. As far as performance for FIRDAPSE and what you should expect, we reiterated guidance for the balance of this year and also, like I just mentioned, the strong leading indicators. as far as performance for firdapse and what you should expect we reiterated guidance for the balance of this year and also like i just mentioned the strong leading indicators We do believe in our business and the foundation of our business for FIRDAPSE, so we expect continued growth. we do believe in our business and the foundation of our business for firdapse so we expect continued growth

Speaker 5: Thanks, Jeff. Thank you. Thanks, Jeff. thanks jeff Thank you. thank you

Speaker 8: Thank you. The next question we have comes from Jason Gerberry of Bank of America. Please go ahead. Thank you. thank you The next question we have comes from Jason Gerberry of Bank of America. the next question we have comes from jason gerberry of bank of america Please go ahead. please go ahead

Speaker 6: Hey guys, thanks for taking my questions. A couple for me. Just given all that's going on with a Elevidys in the, I guess, non-ambulatory group of patients and some of the commentary earlier in the year around queuing, I'm just kind of wondering how that impacts the quarterly kinetics of AGAMREE uptake, if at all. With FIRDAPSE, wondering if you could just maybe comment on sort of the time lag for the NCCN recommendation to have more of an impactful commercial impact. Thanks. Hey guys, thanks for taking my questions. hey guys thanks for taking my questions A couple for me. a couple for me Just given all that's going on with a Elevidys in the, I guess, non-ambulatory group of patients and some of the commentary earlier in the year around queuing, I'm just kind of wondering how that impacts the quarterly kinetics of AGAMREE uptake, if at all. just given all that's going on with a elevidys in the i guess non-ambulatory group of patients and some of the commentary earlier in the year around queuing i'm just kind of wondering how that impacts the quarterly kinetics of agamree uptake if at all With FIRDAPSE, wondering if you could just maybe comment on sort of the time lag for the NCCN recommendation to have more of an impactful commercial impact. with firdapse wondering if you could just maybe comment on sort of the time lag for the nccn recommendation to have more of an impactful commercial impact Thanks. thanks

Speaker 5: Jason, thanks so much. From a commercial perspective, we'll take the Elevidys question. We'll turn it over to Jeff, and if there's more of a clinical, we'll have Will jump in on that. Jeff, you want to take that one first? Jason, thanks so much. jason thanks so much From a commercial perspective, we'll take the Elevidys question. from a commercial perspective we'll take the elevidys question We'll turn it over to Jeff, and if there's more of a clinical, we'll have Will jump in on that. we'll turn it over to jeff and if there's more of a clinical we'll have will jump in on that Jeff, you want to take that one first? jeff you want to take that one first

Speaker 10: Thanks for the question, Jason. With AGAMREE and steroids specifically, they are the foundation of treatment for these boys living with DMD. The impact of the unfortunate news about Elevidys really hasn't impacted much the use of steroids. We do strongly believe that AGAMREE is the steroid of choice. Thanks for the question, Jason. thanks for the question jason With AGAMREE and steroids specifically, they are the foundation of treatment for these boys living with DMD. with agamree and steroids specifically they are the foundation of treatment for these boys living with dmd The impact of the unfortunate news about Elevidys really hasn't impacted much the use of steroids. the impact of the unfortunate news about elevidys really hasn't impacted much the use of steroids We do strongly believe that AGAMREE is the steroid of choice. we do strongly believe that agamree is the steroid of choice

Speaker 5: Will, do you want to jump in there on a clinical? Will, do you want to jump in there on a clinical? will do you want to jump in there on a clinical

Speaker 3: Happy to, Rich. Thank you. We see the new additions to the NCCN guidelines as critical to helping for Elevidys. Happy to, Rich. happy to rich Thank you. thank you We see the new additions to the NCCN guidelines as critical to helping for Elevidys . we see the new additions to the nccn guidelines as critical to helping for elevidys

Speaker 5: For DMD? For DMD? for dmd

Speaker 3: Yes, I'm sorry. The second question was NCCN. Yes, I'm sorry. yes i'm sorry The second question was NCCN. the second question was nccn

Speaker 5: Yes. Yes. yes

Speaker 3: On lElevidys, I would add medically that I agree with Jeff from the perspective of that being an entirely different modality of treatment. As Jeff said, it's unfortunate as to what's happened, but we still see, of course, corticosteroids and AGAMREE as foundational treatment for these kids that are unaffected, we believe, by what's happened with the Elevidys. To answer your second question on the NCCN guidelines, we see that as critical to helping educate oncologists, clinical oncologists on the disease, and very importantly, on how to better diagnose the disease. FIRDAPSE is a critical option for them in the treatment. On lElevidys, I would add medically that I agree with Jeff from the perspective of that being an entirely different modality of treatment. on lelevidys i would add medically that i agree with jeff from the perspective of that being an entirely different modality of treatment As Jeff said, it's unfortunate as to what's happened, but we still see, of course, corticosteroids and AGAMREE as foundational treatment for these kids that are unaffected, we believe, by what's happened with the Elevidys. as jeff said it's unfortunate as to what's happened but we still see of course corticosteroids and agamree as foundational treatment for these kids that are unaffected we believe by what's happened with the elevidys To answer your second question on the NCCN guidelines, we see that as critical to helping educate oncologists, clinical oncologists on the disease, and very importantly, on how to better diagnose the disease. to answer your second question on the nccn guidelines we see that as critical to helping educate oncologists clinical oncologists on the disease and very importantly on how to better diagnose the disease FIRDAPSE is a critical option for them in the treatment. firdapse is a critical option for them in the treatment

Speaker 5: I'll just add, the way we see the cadence working out, Jeff and the team have done a really good job of getting this frictionless testing in there, which we believe was the first step. The physician can order the test, and the report will come to their office. Prior to this, the patient had to actually go to a remote site, get a test, and then get the test results themselves. That's the first step. The NCCN guideline really is the bridge to care pathways within the practice. I'll just add, the way we see the cadence working out, Jeff and the team have done a really good job of getting this frictionless testing in there, which we believe was the first step. i'll just add the way we see the cadence working out jeff and the team have done a really good job of getting this frictionless testing in there which we believe was the first step The physician can order the test, and the report will come to their office. the physician can order the test and the report will come to their office Prior to this, the patient had to actually go to a remote site, get a test, and then get the test results themselves. prior to this the patient had to actually go to a remote site get a test and then get the test results themselves That's the first step. that's the first step The NCCN guideline really is the bridge to care pathways within the practice. the nccn guideline really is the bridge to care pathways within the practice As we get this out there, and it was just released, obviously, last week, we get this out there, the opportunity then is to work through those oncology practices, get the NCCN guidelines embedded as the standard, and NCCN is the true standard within oncology, get that embedded, and then begin talking to the group practices about how they want to use it and how we can be supportive. As Jeff mentioned earlier, on an earlier question, those educational efforts working hand in hand with the GPOs and then beyond the GPOs as well become important. Jeff? As we get this out there, and it was just released, obviously, last week, we get this out there, the opportunity then is to work through those oncology practices, get the NCCN guidelines embedded as the standard, and NCCN is the true standard within oncology, get that embedded, and then begin talking to the group practices about how they want to use it and how we can be supportive. as we get this out there and it was just released obviously last week we get this out there the opportunity then is to work through those oncology practices get the nccn guidelines embedded as the standard and nccn is the true standard within oncology get that embedded and then begin talking to the group practices about how they want to use it and how we can be supportive As Jeff mentioned earlier, on an earlier question, those educational efforts working hand in hand with the GPOs and then beyond the GPOs as well become important. as jeff mentioned earlier on an earlier question those educational efforts working hand in hand with the gpos and then beyond the gpos as well become important Jeff? jeff

Speaker 10: Thanks, Rich. Jason, to your question, when do we expect this to hit commercial and increase some of the net revenue? The way we look at this, again, is increased screening this year, and then next year with more patients, thankfully, being diagnosed, the addressable market increases, and that can help with the treatment with FIRDAPSE. We expect that to take place probably in the second half of next year and beyond is when we start seeing converting some of these diagnosed patients onto FIRDAPSE therapy. Hopefully, that helps. Thanks, Rich. thanks rich Jason, to your question, when do we expect this to hit commercial and increase some of the net revenue? jason to your question when do we expect this to hit commercial and increase some of the net revenue The way we look at this, again, is increased screening this year, and then next year with more patients, thankfully, being diagnosed, the addressable market increases, and that can help with the treatment with FIRDAPSE. the way we look at this again is increased screening this year and then next year with more patients thankfully being diagnosed the addressable market increases and that can help with the treatment with firdapse We expect that to take place probably in the second half of next year and beyond is when we start seeing converting some of these diagnosed patients onto FIRDAPSE therapy. we expect that to take place probably in the second half of next year and beyond is when we start seeing converting some of these diagnosed patients onto firdapse therapy Hopefully, that helps. hopefully that helps

Speaker 6: Thanks, Jeff. Thank you. Thanks, Jeff. thanks jeff Thank you. thank you

Speaker 3: Thanks, Jason. Thanks, Jason. thanks jason

Speaker 8: Thank you. Ladies and gentlemen, just a reminder, if you would like to ask a question, please press star and then one. The next question we have comes from Leland Gershell of Oppenheimer & Co. Please go ahead. Thank you. thank you Ladies and gentlemen, just a reminder, if you would like to ask a question, please press star and then one. ladies and gentlemen just a reminder if you would like to ask a question please press star and then one The next question we have comes from Leland Gershell of Oppenheimer & Co. Please go ahead. the next question we have comes from leland gershell of oppenheimer & co please go ahead

Speaker 2: Oh, great. Good morning, and thanks for taking our questions. Just one from us, just on optics, maybe for Michael. Just wondering, you know, given the realignment in the sales for FIRDAPSE and AGAMREE affected a few months ago, just wondering how you see SG&A expense rolling forward. It looked like it was pretty flattish from Q1 to Q2. Just wondering if we should see a bit of a bump, you know, any increase into the second half. Thank you. Oh, great. oh great Good morning, and thanks for taking our questions. good morning and thanks for taking our questions Just one from us, just on optics, maybe for Michael. just one from us just on optics maybe for michael Just wondering, you know, given the realignment in the sales for FIRDAPSE and AGAMREE affected a few months ago, just wondering how you see SG&A expense rolling forward. just wondering you know given the realignment in the sales for firdapse and agamree affected a few months ago just wondering how you see sg&a expense rolling forward It looked like it was pretty flattish from Q1 to Q2. it looked like it was pretty flattish from q1 to q2 Just wondering if we should see a bit of a bump, you know, any increase into the second half. just wondering if we should see a bit of a bump you know any increase into the second half Thank you. thank you

Speaker 11: Thanks, Leland. Hope all is well. As you know, we did not quantify SG&A guidance. We did talk qualitatively at the beginning of the year. Some of the folks that we had hired were in, obviously, a little before April 1. I think the flat is a little bit to what we'd expect. With the acceleration of the NCCN guidelines, I do think that we will see a little bit of an uptick in the second half. Thanks, Leland. thanks leland Hope all is well. hope all is well As you know, we did not quantify SG&A guidance. as you know we did not quantify sg&a guidance We did talk qualitatively at the beginning of the year. we did talk qualitatively at the beginning of the year Some of the folks that we had hired were in, obviously, a little before April 1. some of the folks that we had hired were in obviously a little before april 1 I think the flat is a little bit to what we'd expect. i think the flat is a little bit to what we'd expect With the acceleration of the NCCN guidelines, I do think that we will see a little bit of an uptick in the second half. with the acceleration of the nccn guidelines i do think that we will see a little bit of an uptick in the second half

Speaker 2: Okay, great. Thanks for taking the question. Okay, great. okay great Thanks for taking the question. thanks for taking the question

Speaker 5: Thanks, Leland. Thanks, Leland. thanks leland

Speaker 8: Thank you. The next question we have comes from Luke Herrmann of Baird. Please go ahead. Thank you. thank you The next question we have comes from Luke Herrmann of Baird. the next question we have comes from luke herrmann of baird Please go ahead. please go ahead

Speaker 12: Hey guys, thanks for taking the question. Two from me. First, on the Change Health disruption, I was wondering if you could share your thoughts on whether all the loose ends have been closed here or if there's potential for any future anomalies. Second, recent language from the administration on pharma tariffs, which has obviously been sort of constantly evolving. I see that FIRDAPSE is manufactured in the U.S. and Canada, and I think you've had a process underway to consider the addition of third-party manufacturers for AGAMREE. I guess, has there been any recent evolution in thinking around the manufacturing strategy? Hey guys, thanks for taking the question. hey guys thanks for taking the question Two from me. two from me First, on the Change Health disruption, I was wondering if you could share your thoughts on whether all the loose ends have been closed here or if there's potential for any future anomalies. first on the change health disruption i was wondering if you could share your thoughts on whether all the loose ends have been closed here or if there's potential for any future anomalies Second, recent language from the administration on pharma tariffs, which has obviously been sort of constantly evolving. second recent language from the administration on pharma tariffs which has obviously been sort of constantly evolving I see that FIRDAPSE is manufactured in the U.S. and Canada, and I think you've had a process underway to consider the addition of third-party manufacturers for AGAMREE. i see that firdapse is manufactured in the u.s and canada and i think you've had a process underway to consider the addition of third-party manufacturers for agamree I guess, has there been any recent evolution in thinking around the manufacturing strategy? i guess has there been any recent evolution in thinking around the manufacturing strategy

Speaker 5: Thanks, Luke. Thanks for the questions. The Change Healthcare issue, the disruption we saw there really was, as we mentioned in the script, really was a pull, sort of a push into the second quarter of 2024. We believe, and we see it, the natural cadence of FIRDAPSE returning post-June of 2024, and now we believe that effect is washed through the system. We're very confident about that because we can see, because of our specialty pharmacy relationship, we can see what's happening there at a very granular level. You may remember in our second first quarter call in May last year, we mentioned that we saw it the day it began to happen, so we were able to take rapid action. Having that specialty pharmacy is a real benefit for us. On the tariff side, you are correct. Thanks, Luke. thanks luke Thanks for the questions. thanks for the questions The Change Healthcare issue, the disruption we saw there really was, as we mentioned in the script, really was a pull, sort of a push into the second quarter of 2024. the change healthcare issue the disruption we saw there really was as we mentioned in the script really was a pull sort of a push into the second quarter of 2024 We believe, and we see it, the natural cadence of FIRDAPSE returning post-June of 2024, and now we believe that effect is washed through the system. we believe and we see it the natural cadence of firdapse returning post-june of 2024 and now we believe that effect is washed through the system We're very confident about that because we can see, because of our specialty pharmacy relationship, we can see what's happening there at a very granular level. we're very confident about that because we can see because of our specialty pharmacy relationship we can see what's happening there at a very granular level You may remember in our second first quarter call in May last year, we mentioned that we saw it the day it began to happen, so we were able to take rapid action. you may remember in our second first quarter call in may last year we mentioned that we saw it the day it began to happen so we were able to take rapid action Having that specialty pharmacy is a real benefit for us. having that specialty pharmacy is a real benefit for us On the tariff side, you are correct. on the tariff side you are correct When you think about the volume of sales based on our guidance, about 66% of sales come from FIRDAPSE as it relates to our guidance for the year. We feel really well protected there. You are also correct on working with third-party manufacturers for AGAMREE and transitioning that to the U.S. We were working on that well before this current administration came into play. We're confident we'll be able to do that in the near term, but it's still going to take a while to actually validate the plan. We feel really good about the opportunity to shield that from tariffs as well in the mid to long term because of the ability to move it to the U.S. When you think about the volume of sales based on our guidance, about 66% of sales come from FIRDAPSE as it relates to our guidance for the year. when you think about the volume of sales based on our guidance about 66% of sales come from firdapse as it relates to our guidance for the year We feel really well protected there. we feel really well protected there You are also correct on working with third-party manufacturers for AGAMREE and transitioning that to the U.S. you are also correct on working with third-party manufacturers for agamree and transitioning that to the u.s We were working on that well before this current administration came into play. we were working on that well before this current administration came into play We're confident we'll be able to do that in the near term, but it's still going to take a while to actually validate the plan. we're confident we'll be able to do that in the near term but it's still going to take a while to actually validate the plan We feel really good about the opportunity to shield that from tariffs as well in the mid to long term because of the ability to move it to the U.S. we feel really good about the opportunity to shield that from tariffs as well in the mid to long term because of the ability to move it to the u.s

Speaker 12: Great, thank you. Great, thank you. great thank you

Speaker 3: Thanks, Luke. Thanks, Luke. thanks luke

Speaker 8: Thank you. The next question we have comes from Jennifer Kim of Cantor. Please go ahead. Thank you. thank you The next question we have comes from Jennifer Kim of Cantor. the next question we have comes from jennifer kim of cantor Please go ahead. please go ahead

Speaker 9: Hi, good morning. Thanks for taking my question. Maybe to start with FIRDAPSE, is there any color you can give around the average dose you've reached for the quarter and maybe expectations on that growth for the rest of the year? Anything you can say about discontinuation rates for the quarter? Hi, good morning. hi good morning Thanks for taking my question. thanks for taking my question Maybe to start with FIRDAPSE, is there any color you can give around the average dose you've reached for the quarter and maybe expectations on that growth for the rest of the year? maybe to start with firdapse is there any color you can give around the average dose you've reached for the quarter and maybe expectations on that growth for the rest of the year Anything you can say about discontinuation rates for the quarter? anything you can say about discontinuation rates for the quarter

Speaker 5: Jeff, do you want to take that? Jeff, do you want to take that? jeff do you want to take that

Speaker 10: Sure, thanks, Rich. Yes, first I'll answer the discontinuation rates. Discontinuation rates were below 20%, the annual discontinuation rate of 20% for FIRDAPSE. Hopefully, were you asking about, Jennifer, were you asking about FIRDAPSE specifically on discontinuation? Sure, thanks, Rich. sure thanks rich Yes, first I'll answer the discontinuation rates. yes first i'll answer the discontinuation rates Discontinuation rates were below 20%, the annual discontinuation rate of 20% for FIRDAPSE. discontinuation rates were below 20% the annual discontinuation rate of 20% for firdapse Hopefully, were you asking about, Jennifer, were you asking about FIRDAPSE specifically on discontinuation? hopefully were you asking about jennifer were you asking about firdapse specifically on discontinuation

Speaker 9: Yes. Yes. yes

Speaker 10: Okay, less than 20% annual discontinuation. What was your first question again? Okay, less than 20% annual discontinuation. okay less than 20% annual discontinuation What was your first question again? what was your first question again

Speaker 5: Dose. Dose. dose

Speaker 10: Since the label expansion in June of last year, we have seen a significant increase to the average daily dose, approximately about 4 milligrams, which is what we had expected. The dose is performing according to what we had expected. Since the label expansion in June of last year, we have seen a significant increase to the average daily dose, approximately about 4 milligrams, which is what we had expected. since the label expansion in june of last year we have seen a significant increase to the average daily dose approximately about 4 milligrams which is what we had expected The dose is performing according to what we had expected. the dose is performing according to what we had expected

Speaker 9: Okay, that's helpful. Maybe a question on FYCOMPA. I think right now, Teva is the only generic for the oral tablet that's launched. I just want to clarify, do they have a 100-day exclusivity? I ask because I wonder whether guidance could prove to be on the conservative side for that product. Okay, that's helpful. okay that's helpful Maybe a question on FYCOMPA. maybe a question on fycompa I think right now, Teva is the only generic for the oral tablet that's launched. i think right now teva is the only generic for the oral tablet that's launched I just want to clarify, do they have a 100-day exclusivity? i just want to clarify do they have a 100-day exclusivity I ask because I wonder whether guidance could prove to be on the conservative side for that product. i ask because i wonder whether guidance could prove to be on the conservative side for that product

Speaker 5: Teva is the only player in the space right now for a generic. They have a 180-day exclusivity. As to whether or not the guidance is too conservative, as we mentioned in the call, we've booked $70 million in sales. Our guidance is $90 million - $95 million. However, we think that there's an opportunity to be cautious here because this is a significant risk. If there is another generic player that could come into the market, and we have not seen them yet, we're taking what we believe is a prudent position for the balance of the year, and we will expect additional generic competitors by mid-December. As you know, Jennifer, sometimes they can load the channel into November. That could affect our X Factory sales. We believe this is a prudent approach to the forecast. Teva is the only player in the space right now for a generic. teva is the only player in the space right now for a generic They have a 180-day exclusivity. they have a 180-day exclusivity As to whether or not the guidance is too conservative, as we mentioned in the call, we've booked $70 million in sales. as to whether or not the guidance is too conservative as we mentioned in the call we've booked $70 million in sales Our guidance is $90 million - $95 million. our guidance is $90 million - $95 million However, we think that there's an opportunity to be cautious here because this is a significant risk. however we think that there's an opportunity to be cautious here because this is a significant risk If there is another generic player that could come into the market, and we have not seen them yet, we're taking what we believe is a prudent position for the balance of the year, and we will expect additional generic competitors by mid-December. if there is another generic player that could come into the market and we have not seen them yet we're taking what we believe is a prudent position for the balance of the year and we will expect additional generic competitors by mid-december As you know, Jennifer, sometimes they can load the channel into November. as you know jennifer sometimes they can load the channel into november That could affect our X Factory sales. that could affect our x factory sales We believe this is a prudent approach to the forecast. we believe this is a prudent approach to the forecast

Speaker 9: Okay, that's helpful. All right, thanks, guys. Okay, that's helpful. okay that's helpful All right, thanks, guys. all right thanks guys

Speaker 5: Sure, thank you. Sure, thank you. sure thank you

Speaker 8: Thank you. Ladies and gentlemen, just a final reminder. If you would like to ask a question, please press star and then one now. The next question we have comes from Sudan Loganathan of Stephens Inc. Please go ahead. Thank you. thank you Ladies and gentlemen, just a final reminder. ladies and gentlemen just a final reminder If you would like to ask a question, please press star and then one now. if you would like to ask a question please press star and then one now The next question we have comes from Sudan Loganathan of Stephens Inc. Please go ahead. the next question we have comes from sudan loganathan of stephens inc please go ahead

Speaker 7: Thanks. Good morning, Catalyst Pharmaceuticals team, and congrats on another strong quarter, and thank you for taking my questions. The first one, I want to ask how you view the potential for PTC's Translarna FDA approval for a DMD treatment to affect how AGAMREE will continue to fit in, retain market share, and continue to grow in this space. Secondly, what is your current stance on near-term strategic initiatives to offset FYCOMPA's LOE? Are there any ongoing discussions with potential partners regarding a commercial stage asset or a late-stage pipeline asset? Thanks. thanks Good morning, Catalyst Pharmaceuticals team, and congrats on another strong quarter, and thank you for taking my questions. good morning catalyst pharmaceuticals team and congrats on another strong quarter and thank you for taking my questions The first one, I want to ask how you view the potential for PTC's Translarna FDA approval for a DMD treatment to affect how AGAMREE will continue to fit in, retain market share, and continue to grow in this space. the first one i want to ask how you view the potential for ptc's translarna fda approval for a dmd treatment to affect how agamree will continue to fit in retain market share and continue to grow in this space Secondly, what is your current stance on near-term strategic initiatives to offset FYCOMPA's LOE? secondly what is your current stance on near-term strategic initiatives to offset fycompa's loe Are there any ongoing discussions with potential partners regarding a commercial stage asset or a late-stage pipeline asset? are there any ongoing discussions with potential partners regarding a commercial stage asset or a late-stage pipeline asset

Speaker 5: I think appropriate to turn that to Jeff for the first part. I think appropriate to turn that to Jeff for the first part. i think appropriate to turn that to jeff for the first part

Speaker 10: Yeah, Sudan, just like similar to a Elevidys, you know, the way we look at this is AGAMREE and steroids are the balance of treatment. Translarna does not impact that at all. We just continue to feel strongly about AGAMREE's potential moving forward because we do believe it is the best and differentiated steroid out there for boys living with DMD. As far as. Yeah, Sudan, just like similar to a Elevidys, you know, the way we look at this is AGAMREE and steroids are the balance of treatment. yeah sudan just like similar to a elevidys you know the way we look at this is agamree and steroids are the balance of treatment Translarna does not impact that at all. translarna does not impact that at all We just continue to feel strongly about AGAMREE's potential moving forward because we do believe it is the best and differentiated steroid out there for boys living with DMD. we just continue to feel strongly about agamree's potential moving forward because we do believe it is the best and differentiated steroid out there for boys living with dmd As far as. as far as

Speaker 5: I'm sorry, Sudan, could you just repeat your question? I lost you for a second. Repeat the second question. I'm sorry, Sudan, could you just repeat your question? i'm sorry sudan could you just repeat your question I lost you for a second. i lost you for a second Repeat the second question. repeat the second question

Speaker 7: Yeah, so the second one was just your current stance on the near-term strategic initiatives to offset the FYCOMPA LOE. If there's any ongoing discussions with either a commercial stage asset or a late-stage pipeline asset that you're kind of leaning towards in this market environment, or, you know, how you're viewing that going forward. Yeah, so the second one was just your current stance on the near-term strategic initiatives to offset the FYCOMPA LOE. yeah so the second one was just your current stance on the near-term strategic initiatives to offset the fycompa loe If there's any ongoing discussions with either a commercial stage asset or a late-stage pipeline asset that you're kind of leaning towards in this market environment, or, you know, how you're viewing that going forward. if there's any ongoing discussions with either a commercial stage asset or a late-stage pipeline asset that you're kind of leaning towards in this market environment or you know how you're viewing that going forward

Speaker 5: Thanks for clarifying. On our business development front, as we look to offset, we think of our business in two elements, right? The business development front, bringing in new assets. We are incredibly busy. We believe this is probably one of the best buying environments we've seen in the last 15 or 20 years. Our team is assessing multiple opportunities at any point in time. As mentioned on previous calls, we continue to see 80% of the opportunities coming to us inbound. Other companies will approach us or other parties will approach us about opportunities. We're really excited about building, continuing to build a portfolio. In addition to that, a second pillar of our business is lifecycle management. Thanks for clarifying. thanks for clarifying On our business development front, as we look to offset, we think of our business in two elements, right? on our business development front as we look to offset we think of our business in two elements right The business development front, bringing in new assets. the business development front bringing in new assets We are incredibly busy. we are incredibly busy We believe this is probably one of the best buying environments we've seen in the last 15 or 20 years. we believe this is probably one of the best buying environments we've seen in the last 15 or 20 years Our team is assessing multiple opportunities at any point in time. our team is assessing multiple opportunities at any point in time As mentioned on previous calls, we continue to see 80% of the opportunities coming to us inbound. as mentioned on previous calls we continue to see 80% of the opportunities coming to us inbound Other companies will approach us or other parties will approach us about opportunities. other companies will approach us or other parties will approach us about opportunities We're really excited about building, continuing to build a portfolio. we're really excited about building continuing to build a portfolio In addition to that, a second pillar of our business is lifecycle management. in addition to that a second pillar of our business is lifecycle management When we talk about the opportunity around AGAMREE, looking for opportunities to better understand the molecule and how it might play in the orphan and rare space, we continue to do that work. On the commercial front, in diversifying our opportunities with FIRDAPSE, we believe the oncology play and the dedicated sales force can continue to work to offset the loss of FYCOMPA. When we talk about the opportunity around AGAMREE, looking for opportunities to better understand the molecule and how it might play in the orphan and rare space, we continue to do that work. when we talk about the opportunity around agamree looking for opportunities to better understand the molecule and how it might play in the orphan and rare space we continue to do that work On the commercial front, in diversifying our opportunities with FIRDAPSE, we believe the oncology play and the dedicated sales force can continue to work to offset the loss of FYCOMPA. on the commercial front in diversifying our opportunities with firdapse we believe the oncology play and the dedicated sales force can continue to work to offset the loss of fycompa

Speaker 7: I appreciate that. Thank you. I appreciate that. i appreciate that Thank you. thank you

Speaker 5: Thank you. Thank you. thank you

Speaker 8: Thank you. Ladies and gentlemen, that then brings an end to our question and answer session. Thank you for joining today's conference. You may now disconnect your lines. Thank you. thank you Ladies and gentlemen, that then brings an end to our question and answer session. ladies and gentlemen that then brings an end to our question and answer session Thank you for joining today's conference. thank you for joining today's conference You may now disconnect your lines. you may now disconnect your lines