Earnings Call Transcript - CPRX Q2 2025

Operator, Operator

Greetings, and welcome to the Catalyst Pharmaceuticals Second Quarter 2025 Financial Results Conference Call. 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.

Michael W. Kalb, CFO

Thank you. Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's 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 the 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. At this time, I'll turn the call over to Rich. Rich?

Richard John Daly, CEO

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 timing 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 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 healthcare providers 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 the 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 EMFLAZA, a strong 90% patient retention rate, and growing adoption across Duchenne's 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 I study comparing AGAMREE, prednisone, and deflazacort to determine the potential switching algorithms. Additionally, we are working to assess the immunosuppressive effects of AGAMREE that could help us define the life cycle 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 in 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 Catalyst's 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.

Jeffrey Del Carmen, CFO

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 3-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, particularly oncologists, to order BGCC 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 BGCC 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 health care providers have submitted enrollment forms. In Q2, approximately 43% of patients transitioned from prednisone and 42% from EMFLAZA, 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 and 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.

Michael W. Kalb, CFO

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 the 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, 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. 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 2 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.

Richard John Daly, CEO

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.

Operator, Operator

First question that we have comes from Samantha Semenkow of Citibank.

Samantha Lynn Semenkow, Analyst

A couple first on FIRDAPSE. Can you speak more about your strategy for educating oncologists on the LEMS opportunity? And I'm curious what metrics are you using to track the success of the campaign? And then 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.

Richard John Daly, CEO

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

Jeffrey Del Carmen, CFO

Sure. Sam, good to hear from you. As we noted in the script, I think our approach to oncology and the addressable market there for cancer-associated LEMS, the first thing we really wanted to do was increase the provide frictionless testing for these patients. And we were able to make that happen where oncologists and all healthcare providers could order our no-cost VGCC antibody test within their office. So that shortened the time to the diagnostic. Secondly, the NCCN guideline changes. So you heard that in July 25, that those changes happen. So those were the first two steps. And now we're working with the group practices and trying to put together some arrangements with them for screening. So 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 a publication plan, working with our medical team on that to do abstracts as well. So 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. So if we can help these patients get diagnosed, then we anticipate a larger addressable market that we should start seeing an increase in that percentage in 2026 and beyond. So that's how we're looking at this, Sam.

Samantha Lynn Semenkow, Analyst

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 EMFLAZA 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.

Richard John Daly, CEO

Thanks, Sam. I'm going to hand it over to Bill Andrews, our Chief Medical Officer. We're definitely waiting for the data, which will guide how we use it. Since the study is still ongoing, it's a bit difficult to answer your question directly. Will, do you want to address that?

William T. Andrews, Chief Medical Officer

Yes. Thank you, Rich, and hello, Sam. The study is an exploratory trial, and 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 conduct future studies to further explore potential switching and related aspects.

Operator, Operator

The next question we have comes from Joon Lee of Truist Securities.

Asim Rana, Analyst

Congrats on the quarter. This is Asim on for Joon. Just a couple from us. So what impact are you seeing on FIRDAPSE and AGAMREE uptake following the increase in sales force size that became effective on April 1? And then 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?

Richard John Daly, CEO

Thanks for the question, Asim. Jeff will address that question now.

Jeffrey Del Carmen, CFO

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 exceeding or meeting and exceeding the enrollments thus far in July. So 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. So that also increased from the second quarter. So 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. So we do believe in our business and the foundation of our business for FIRDAPSE, so we expect continued growth.

Operator, Operator

The next question we have comes from Jason Gerberry of Bank of America.

Jason Matthew Gerberry, Analyst

A couple for me. Just given all that's going on with ELEVIDYS in the, I guess, nonambulatory 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? And then with FIRDAPSE, I'm 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.

Richard John Daly, CEO

Jason, thanks so much. So from a commercial perspective, we'll take the ELEVIDYS question. We'll turn it over to Jeff. And if they're more of a clinical, we'll have Will jump in on that. But Jeff, do you want to take that one first?

Jeffrey Del Carmen, CFO

Thanks for the question, Jason. And with AGAMREE and steroids specifically, they are the foundation of treatment for these boys living with DMD. So the impact of the unfortunate news about ELEVIDYS really hasn't impacted much the use of steroids. And we do strongly believe that AGAMREE is the steroid of choice.

Richard John Daly, CEO

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

William T. Andrews, Chief Medical Officer

Happy to, Rich. Thank you. We see the new additions to the NCCN guidelines as critical to help educate oncologists. Very importantly, on how to better diagnose the disease, and that amifampridine is a critical option for them in the treatment.

Richard John Daly, CEO

And 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 is the first step. So that 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. So that's the first step. The NCCN guideline really is the bridge to care pathways within the practice. So 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 and get these 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. And then 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?

Jeffrey Del Carmen, CFO

Thanks, Rich. And 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 then that can help with the treatment with FIRDAPSE. So 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.

Operator, Operator

The next question we have comes from Leland Gershell of Oppenheimer & Co.

Leland James Gershell, Analyst

Just one from us, just on OpEx, maybe for Michael. Just wondering, 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 looks like it was pretty flattish from Q1 to Q2. Just wondering if we should see a bit of a bump and the increase into the second half.

Michael W. Kalb, CFO

Thanks, Leland, and I hope all is well. So 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. So I think the flat is a little bit to what we'd expect. But to your point, with the acceleration of the NCCN guidelines, I do think that we will see a little bit of an uptick in the second half.

Operator, Operator

The next question we have comes from Luke Herrmann of Baird.

Luke P. Herrmann, Analyst

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. And then 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 addition of third-party manufacturers for AGAMREE. I guess, has there been any recent evolution in thinking around the manufacturing strategy?

Richard John Daly, CEO

Thank you for your questions, Luke. Regarding the Change Healthcare issue, the disruption we experienced was essentially a push into the second quarter of 2024. We anticipate that the natural rhythm of FIRDAPSE will return after June 2024, and we believe that the impact has now been fully absorbed. We are confident in this outlook due to our detailed insights from our specialty pharmacy relationship. You might recall that during our first-quarter call in May last year, we detected the issue as it began, allowing us to act quickly. Having that specialty pharmacy has been a significant advantage for us. On the tariff front, you are correct that about 66% of our sales are related to FIRDAPSE according to our guidance for the year, and we feel well protected in that regard. Additionally, we are indeed working with third-party manufacturers for AGAMREE and began this process before the current administration took office. We are optimistic about completing this transition in the near future, although it will take time to validate the plant. Nevertheless, we are hopeful about minimizing the impact of tariffs in the mid- to long-term by moving production to the U.S.

Operator, Operator

The next question we have comes from Jennifer Kim of Cantor.

Jennifer M. Kim, Analyst

Maybe to start with FIRDAPSE. Can you provide any insights on the average dose you achieved for the quarter and your expectations for growth for the remainder of the year? Additionally, can you share anything about the discontinuation rates for the quarter?

Richard John Daly, CEO

Jeff, do you want to take that?

Jeffrey Del Carmen, CFO

Sure. Thanks, Rich. I'll address the discontinuation rates first. The annual discontinuation rate for FIRDAPSE was below 20%. Jennifer, were you specifically inquiring about FIRDAPSE's discontinuation? Yes, it is under 20% annually. Could you remind me what your first question was?

Richard John Daly, CEO

Dose.

Jeffrey Del Carmen, CFO

Since the label expansion in June of last year, we have observed a significant increase in the average daily dose, which is now approximately 4 milligrams, aligning with our expectations. The dose is performing as we anticipated.

Jennifer M. Kim, Analyst

Okay. That's helpful. And 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? And I asked because I wonder whether guidance could prove to be on the conservative side for that product.

Richard John Daly, CEO

Teva is currently the only company with a generic in this market. They have exclusive rights for 180 days. As for whether our guidance is too cautious, we have recorded $70 million in sales so far, while our guidance is between $90 million to $95 million. We believe it's wise to be careful because there is a significant risk of new competitors entering the market, although we have not seen any yet. Therefore, we are adopting a cautious stance for the remainder of the year, anticipating additional generic competitors by mid-December. Additionally, as you know, there are times when they can stock the channel by November, which might impact our ex-factory sales. So, we feel this approach to forecasting is sensible.

Operator, Operator

The next question we have comes from Sudan Loganathan of Stephens Inc.

Sudan Naveen Loganathan, Analyst

Catalyst Pharma team, congrats on another strong quarter. First one, I want to ask how you view the potential for PTCT's Translarna FDA approval for DMD treatment to affect how AGAMREE will continue to fit in, retain market share and continue to grow in this space? And then 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?

Richard John Daly, CEO

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

Jeffrey Del Carmen, CFO

Yes, Sudan. Similar to ELEVIDYS, we view AGAMREE and steroids as the foundation of treatment. Translarna does not impact that at all. We continue to feel strongly about AGAMREE's potential moving forward because we believe it is the best and most differentiated steroid for boys living with DMD.

Richard John Daly, CEO

Well, sorry, Sudan, could you just repeat your question? I lost you for a second. Repeat the second question.

Sudan Naveen Loganathan, Analyst

Yes. The second one was just on your current stance on the near-term strategic initiatives to offset the FYCOMPA LOE, if there's any ongoing discussions with either commercial stage asset or late-stage pipeline asset that you're kind of leaning towards in this market environment? Or how you're viewing that going forward?

Richard John Daly, CEO

Thanks for clarifying. On the business development front, we view our operations in two key aspects. First, we are focused on bringing in new assets and are currently very active. We believe this is one of the best buying environments we've encountered in the last 15 to 20 years. Our team is evaluating multiple opportunities constantly, and as noted in prior calls, around 80% of these opportunities are inbound, meaning other companies and parties are approaching us. We are excited about continuing to expand our portfolio. The second aspect of our business is lifecycle management. Regarding AGAMREE, we are seeking ways to better understand the molecule and its potential in the orphan and rare disease space, and we are diligently working on that. Additionally, in terms of diversifying our commercial opportunities with FIRDAPSE, we believe that the oncology sector and our dedicated sales force can effectively help mitigate the impact of the FYCOMPA loss.

Operator, Operator

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.