Catalyst Pharmaceuticals - Earnings Call - Q2 2025

Transcript

Speaker 6

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, Michael Kalb. Please go ahead, sir.

Speaker 3

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?

Speaker 0

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 to $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 to $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 to $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 to $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 2, 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 one 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 7, 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 Pharmaceuticals 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.

Speaker 7

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 anti-GAD65 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 anti-GAD65 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 25, which now include anti-GAD65 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 Pharmaceuticals 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.

Speaker 3

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 Resurgi 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 Resurgi 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 1, 2025. As reported, at June 30, 2025, we had cash and cash equivalents of $652.8 million compared to $517.6 million at December 31, 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.

Speaker 0

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.

Speaker 6

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 to 25% of revenues come from oncology patients. Thank you.

Speaker 0

Thanks, Samantha. I appreciate the question. I'm going to turn that to Jeff. Jeff, do you want to take it on?

Speaker 7

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 anti-GAD65 antibody test within their office. That shortened the time to the diagnostic. Secondly, the NCCN guideline changes. You heard that on July 25, 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 anti-GAD65 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 one 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.

Speaker 0

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?

Speaker 2

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.

Speaker 0

Thank you, Sam.

Speaker 6

Thank you. Thank you. The next question we have comes from June Lee of Truist Securities. Please go ahead.

Congrats on the quarter, and thanks for taking the questions. This is Asuman for June, 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.

Speaker 0

Thanks, Asha. I think, again, it's Jeff's going to answer that question, so thanks for the question. Jeff?

Speaker 7

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.

Speaker 0

Thanks, Jeff. Thank you.

Speaker 6

Thank you. The next question we have comes from Jason Gowry 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 levitus 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.

Speaker 0

Jason, thanks so much. From a commercial perspective, we'll take the levitus 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?

Speaker 7

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 alevitus really hasn't impacted much the use of steroids. We do strongly believe that Agamree is the steroid of choice.

Speaker 0

Will, do you want to jump in there on a clinical?

Speaker 2

Happy to, Rich. Thank you. We see the new additions to the NCCN guidelines as critical to helping for levitus.

Speaker 0

For DMD?

Speaker 2

Yes, I'm sorry. The second question was NCCN.

Speaker 0

Yes.

Speaker 2

On levitus, 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 levitus. 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.

Speaker 0

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?

Speaker 7

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.

Speaker 0

Thanks, Jeff. Thank you.

Speaker 2

Thanks, Jason.

Speaker 6

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 Gershall 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.

Speaker 3

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.

Speaker 0

Thanks, Leland.

Speaker 6

Thank you. The next question we have comes from Luke Hellman of BED. 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?

Speaker 2

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.

Speaker 6

Thank you. The next question we have comes from Jennifer Kim of Cowen. 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?

Speaker 2

Jeff, do you want to take that?

Speaker 7

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?

Speaker 6

Yes.

Speaker 7

Okay, less than 20% annual discontinuation. What was your first question again?

Speaker 2

Dose.

Speaker 7

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.

Speaker 2

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 to $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.

Speaker 6

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 Sudhan 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?

Speaker 2

I think appropriate to turn that to Jeff for the first part.

Speaker 7

Yeah, Sudan, just like similar to a levitus, you know, the way we look at this is Agamree and steroids are the balance of treatment. TransLarina 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.

Speaker 2

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.

Speaker 6

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.