Earnings call transcript: Catalyst Pharmaceuticals Q2 2025 beats EPS forecast

Catalyst Pharmaceuticals reported its Q2 2025 earnings, showcasing a significant earnings per share (EPS) beat with actual EPS of $0.68 compared to the forecasted $0.39, representing a 74.36% surprise. The company also surpassed revenue expectations, reporting $146.54 million against a forecast of $140.22 million. With an impressive gross margin of 83.5% and an excellent InvestingPro Financial Health score of 4.08 out of 5, the company demonstrates robust operational efficiency. Despite these positive earnings results, Catalyst’s stock experienced a decline of 7.66% in the latest trading session, closing at $21.79, down from a last close value.

Key Takeaways

• Catalyst Pharmaceuticals exceeded EPS and revenue forecasts for Q2 2025.
• The stock price fell by 7.66% despite strong earnings.
• Year-over-year revenue increased by 19.4%.
• Significant growth in GammaRy product sales, up 213% YoY.
• Full-year revenue guidance set between $545 million and $565 million.

Company Performance

Catalyst Pharmaceuticals demonstrated robust performance in Q2 2025 with a total revenue of $146.6 million, marking a 19.4% increase from the same period last year. The company’s year-to-date revenue reached $288 million, reflecting a 30.2% growth. With a strong current ratio of 6.71 and minimal debt, Catalyst maintains excellent financial flexibility for future growth. This performance highlights Catalyst’s strategic focus on expanding its product offerings and market reach. InvestingPro subscribers have access to over 30 additional financial metrics and insights that provide a comprehensive view of Catalyst’s financial strength and market position.

Financial Highlights

• Revenue: $146.6 million, up 19.4% YoY
• Non-GAAP EPS: $0.68, exceeding forecast by 74.36%
• GAAP net income: $52.1 million, up 27.7% YoY
• Cash position: $652.8 million
• Effective tax rate: 22.6%, down from 24.5% in 2024

Earnings vs. Forecast

Catalyst Pharmaceuticals reported an EPS of $0.68, significantly higher than the forecasted $0.39, resulting in a 74.36% surprise. The company’s revenue also exceeded expectations, with a 4.51% surprise over the projected $140.22 million. This performance marks a strong quarter for Catalyst, continuing its trend of exceeding market expectations.

Market Reaction

Despite the earnings beat, Catalyst Pharmaceuticals’ stock fell by 7.66% to $21.79, a movement that contrasts with the positive financial results. Trading at a P/E ratio of 12.4 and EV/EBITDA of 6.34, InvestingPro analysis suggests the stock is currently undervalued, with multiple ProTips indicating strong financial health and growth potential. This decline may reflect investor concerns or profit-taking following a recent high. The stock’s price remains within its 52-week range, with a high of $26.58 and a low of $17.23. Investors seeking deeper insights can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers, which provides detailed analysis of Catalyst’s valuation and growth prospects.

Outlook & Guidance

Catalyst Pharmaceuticals has set its full-year revenue guidance between $545 million and $565 million. The company remains focused on expanding its oncology market for Firdapse and exploring further business development opportunities. Additionally, the full-year revenue guidance for Firdapse is $355-360 million, while Fycompa’s is $90-95 million.

Executive Commentary

CEO Richard Daley emphasized the company’s strong momentum and strategic growth focus, stating, "We are entering 2025 with strong momentum, clearly defined growth drivers, and a focused strategy to deliver long-term value and impact for patients." Chief Commercial Officer Jeffrey Del Carmen added, "We expect momentum to build in the months ahead, setting the stage for sustained growth in 2026 and beyond."

Risks and Challenges

• Potential impact from competitor treatments could affect market share.
• Increased personnel costs and R&D expenses may pressure margins.
• Market saturation in key product areas could limit growth.
• Macroeconomic pressures and potential tariffs could impact manufacturing strategy.
• Undiagnosed patient populations present both opportunities and challenges for market expansion.

Q&A

During the earnings call, analysts inquired about the impact of updated NCCN guidelines on the oncology market and the company’s manufacturing strategy to mitigate potential tariffs. Catalyst also addressed concerns about competitor treatments and detailed its strategy for expanding LEMS patient diagnosis.

Full transcript - Catalyst Pharmaceuticals Inc (CPRX) Q2 2025:

Conference Operator: Greetings, and welcome to the Catalyst Pharmaceuticals Second Quarter twenty twenty five Financial Results Conference Call. At this time, all participants are in listen only mode. A question and answer session will follow the formal presentation. 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.

Mike Kalb, Chief Financial Officer, Catalyst Pharmaceuticals: Thank you. Good morning, everyone, and thank you for joining our conference call to discuss Catalyst’s second quarter twenty twenty five financial results and business highlights. Richard Daley, President and CEO, will lead the call today and Jeffrey Del Carmen, our Chief Commercial Officer, and I will also present. Additionally, Doctor. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer and Doctor.

Will Andrews, our Chief Medical Officer, will be available for the Q and A. Before we begin, I would like to remind you that in our remarks this morning and in the Q and A session, we will make statements about expected future results, which may be forward looking statements for purposes of federal securities laws. These statements 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 ks filed with the SEC on 02/26/2025, and in our second quarter twenty twenty five quarterly report on Form 10 Q, which was filed yesterday, 08/06/2025 with the SEC. At this time, I’ll turn the call over to Rich. Rich?

Richard Daley, President and CEO, Catalyst Pharmaceuticals: Thanks, Mike. Good morning, everyone, and thank you for joining us. Catalyst delivered another record setting quarter in Q2 twenty twenty five with total revenue reaching $146,600,000 an increase of 19.4% year over year. For the 2025, total revenue grew 30.2% to $288,000,000 reflecting strong execution and sustained demand for our differentiated portfolio. We ended the 2025 with a cash position of $652,800,000 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 $545,000,000 to $565,000,000 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 $84,800,000 in Q2 twenty twenty five, a growth of $7,500,000 versus Q2 twenty twenty four. As we discussed in our Q1 twenty twenty five 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 twenty twenty four to Q2 twenty twenty four was fully resolved by the June 2024.

As a result, we believe that comparing Firdapse first half twenty twenty five 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 $168,600,000 in net product revenue, representing a 16.9% increase over the 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 $355,000,000 to $360,000,000 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 ninety percent 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 a 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 a GammaRy.

GammaRy continues to outperform expectations generating $27,400,000 in net product revenue in Q2 twenty twenty five, a new post launch high and a two thirteen percent increase year over year from Q2 twenty twenty four. First half net revenues reached $49,400,000 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. Agamarin’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, Agamemi is well positioned to continue momentum.

We are reaffirming Agamemi’s full year 2025 net product revenue guidance of $100,000,000 to $110,000,000 Let’s switch to Fycompa. Fycompa delivered solid results in the 2025 with revenue of $34,300,000 reflecting a year over year decrease of 6%. First half twenty twenty five revenue reached $70,000,000 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 90,000,000 to $95,000,000 for Fycompa remains unchanged. We recently strengthened our corporate and board leadership.

I’d like to formally welcome Doctor. Will Andrews as our new Chief Medical Officer. Will joined Catalyst on 06/02/2025. 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 a GammaRy within the Duchenne’s 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 a gamma ray, Will is leading the SUMMIT study, which aims to generate real world evidence in support of the appropriate use of the gamma ray. 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 a gamma ray, prednisone and deflazacort to determine the potential switching algorithms.

Additionally, we are working to assess the immunosuppressive effects of a gamma ray that could help us define the lifecycle management potential of a gamma ray. Initial results are expected by the 2025 to early twenty twenty six. 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 Doctor. Dan Curran joined our Board of Directors.

We are pleased to welcome Doctor. 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 align 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 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 twenty twenty five or Q1 twenty twenty six. We expect more clarity on this issue on or after our Markman hearing, which is scheduled for 10/07/2025. 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 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’ll provide additional insights into our commercial performance.

Jeffrey Del Carmen, Chief Commercial Officer, Catalyst Pharmaceuticals: 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 VYKAMBA and accelerating adoption of a GammaRay, Q2 net product revenue of $146,500,000 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 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 sites. 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 $1,000,000,000 addressable market opportunity. As we advance these priorities, we are implementing a three step program of targeted initiatives designed to enhance diagnostic access in 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 25, 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 ninety percent 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 Agamry.

Agamry continues to demonstrate strong early market momentum as a differentiated treatment for Duchenne muscular dystrophy. Q2 twenty twenty five net product revenue was $27,400,000 Adoption continues to expand across key centers. To date, 93% of the top 45 DMD centers of excellence and two thirty one unique healthcare providers have submitted enrollment forms. In Q2, approximately forty three percent of patients transitioned from prednisone and forty two percent from Emflaza, underscoring Agamry’s broad clinical relevance across standard treatment segments. Reimbursement success remains high at approximately eighty five percent 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. VYKAMPa delivered Q2 twenty twenty five net product revenue of 34,300,000.0 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 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 VICampa 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 twenty twenty five. With that, I’ll turn the call back over to Mike.

Mike Kalb, Chief Financial Officer, Catalyst Pharmaceuticals: Thank you, Jeff. Our performance during the 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 Agamry, which we launched in 2024 and the solid performance of Fycompa, which currently has only one generic competitor for the tablets following patent expiry in May 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 2025 were $146,600,000 an approximate 19.4% increase when compared to total revenues of $122,700,000 for the 2024. Product revenue net for our lead product Firdapse was $84,800,000 a 9.7% increase year over year compared to $77,400,000 As a reminder, the 2024 benefited from the Change Healthcare cybersecurity incident that occurred in the 2024, which is evidenced by the fact that our growth in net product revenue preferred apps for the 2025 compared to the 2024 was 16.9%. Product revenue net for the 2025 for Fycompa was $34,300,000 compared to $36,500,000 in the 2024. Product revenue net in the 2025 for GammaRy was $27,400,000 as compared to $8,700,000 in the 2024, representing a year over year increase of approximately 213%. Net income before income taxes for the 2025 was $69,300,000 a 24.2% increase year over year compared to $55,800,000 for the 2024.

We reported GAAP net income for the second quarter of twenty twenty five of fifty two point one million dollars or $0.41 per diluted share. GAAP net income increased by 27.7% year over year compared to GAAP net income for the 2024 of $40,800,000 or $0.33 per diluted share. Non GAAP net income for the 2025 was $86,400,000 or $0.68 per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of Vicompa, Agamry and Resurgi of $9,300,000 stock based compensation expense of $7,600,000 income tax provision of $17,200,000 and depreciation of $100,000 This compares to non GAAP net income for the 2024 of $69,600,000 or $0.56 per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of Fycompa, Agamry and Resurgi of $9,300,000 stock based compensation expense of $4,400,000 the income tax provision of $15,000,000 and depreciation of $100,000 Our year to date effective income tax rate through the 2025 was 22.6% compared to 24.5% through the 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 $20,600,000 in the 2025 compared to $15,400,000 in the 2024 and consisted principally of royalties. As a reminder, Agamry royalties paid to the product licensor equal 5% of net sales up to $100,000,000 7% of net sales in excess of $100,000,000 and up to $200,000,000 with additional increases as net sales increase beyond $200,000,000 The company is also required to make a $12,500,000 sales based milestone payment once Agamry’s net product revenue reaches $100,000,000 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 Gamri are disclosed in our Q2 twenty twenty five Form 10 Q. Research and development expenses were $4,400,000 in the 2025, up 46% from $3,000,000 in the 2024. Our R and D spending in the 2025 was comprised mainly of costs to support our ongoing GAMRI studies.

Selling, general and administrative or SG and A expenses for the 2025 totaled $45,900,000 compared to $40,700,000 in the 2024. The increase in SG and A expenses for the 2025 was primarily driven by increased personnel costs, including the implementation of two dedicated sales forces for Firdapse and GammaRy, which became effective on 04/01/2025. As reported, at 06/30/2025, we had cash and cash equivalents of $652,800,000 compared to $517,600,000 at 12/31/2024. The increase in cash of $135,200,000 was primarily driven by $131,300,000 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 and 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 twenty twenty five financial performance may be found in our quarterly report on Form 10 Q, which was filed with the Securities and Exchange Commission yesterday, 08/06/2025 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 Daley, President and CEO, Catalyst Pharmaceuticals: 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 2025. I’ll now turn the call back over to the operator. Thank you.

Conference Operator: Thank you, sir. Ladies and gentlemen, we will now be conducting a question and answer session. First question that we have comes from Samantha Ciminico of Citibank. Please go ahead.

Samantha Ciminico, Analyst, Citibank: 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? 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. Thank you.

Richard Daley, President and CEO, Catalyst Pharmaceuticals: Thanks Samantha. Appreciate the question. I’m going to turn that to Jeff. Jeff, do want to take on? Sure.

Will Andrews, Chief Medical Officer, Catalyst Pharmaceuticals: Hi Sam. Good to hear from you.

Jeffrey Del Carmen, Chief Commercial Officer, Catalyst Pharmaceuticals: As we noted in the script, I think the our approach to oncology in the addressable market there for cancer associated LEMS. The first thing we really wanted to do was, you know, increase the provide frictionless testing for these patients. And we were able to make that happen where oncologists and all HCPs could order our no cost VGCC antibody tests within their office. So that shortened the time to diagnostic. Secondly, the NCCN guideline changes.

So you heard that in July 25 that those changes happened. So those were the first two steps. And now we’re working on working with the group practices and trying to put together some arrangements with them to for screening. So that’s the third step. How are we gonna educate these physicians?

We’re focused on digital marketing. We’re also doing congresses and conferences and 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 gonna 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. Ninety percent 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 Ciminico, Analyst, Citibank: 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 Edflaza to a gamma ray. I’m wondering how do you plan to leverage this data as you commercialize a gamma ray or is it for additional studies that you’re planning?

Just any context you could share there would be very helpful. Thank you.

Richard Daley, President and CEO, Catalyst Pharmaceuticals: 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. So obviously, the study is ongoing. So I think it becomes a little challenging to answer your question directly.

But Will, do you want take that?

Will Andrews, Chief Medical Officer, Catalyst Pharmaceuticals: 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 then early into 2026. And that data will describe be descriptive and will help indicate whether we need to do future studies to further delineate potential switching etcetera.

Samantha Ciminico, Analyst, Citibank: Understood. Thanks very much for the question.

Richard Daley, President and CEO, Catalyst Pharmaceuticals: Thank you, Sam.

Conference Operator: Thank you. Thank you. The next question we have comes from Joon Lee of Truist Securities. Please go ahead.

Jeffrey Del Carmen, Chief Commercial Officer, Catalyst Pharmaceuticals: Congrats on the quarter and thanks for taking the questions. This is Asim on for June. Just a couple from us. So what impact are you seeing on Firdapse and a GAMRE uptake following the increase in sales force size that became effective on April 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?

Thank you.

Richard Daley, President and CEO, Catalyst Pharmaceuticals: Thanks, Asha. I think again, Jeff is going answer that question. So thanks for the question. Jeff?

Jeffrey Del Carmen, Chief Commercial Officer, Catalyst Pharmaceuticals: Thanks for the question. Like you said, we deployed dedicated sales forces for both a GammaRee 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 the GammaRay two, we’ve seen the two thirty one 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 indicator. So we do believe in our business and the foundation of our business for Firdapse. So we expect continued growth.

Richard Daley, President and CEO, Catalyst Pharmaceuticals: Thanks, Jeff.

Jeffrey Del Carmen, Chief Commercial Officer, Catalyst Pharmaceuticals: Thank you.

Conference Operator: Thank you. The next question we have comes from Jason Playsenberry of Bank of America. Please go ahead.

Jason Playsenberry, Analyst, Bank of America: Hey guys, thanks for taking my questions. A couple for me. Just given all that’s going on with Elevitus 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 gamma ray uptake, if at all? And then 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.

Richard Daley, President and CEO, Catalyst Pharmaceuticals: Jason, thanks so much. So from a commercial perspective, we’ll take the Elevator’s 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, you want to take that one first? Thanks for

Jeffrey Del Carmen, Chief Commercial Officer, Catalyst Pharmaceuticals: the question, Jason. And with the gamma ray and steroids specifically, they are the foundation of treatment for these boys living with DMD. So the impact of the unfortunate news about Alevitus it really hasn’t impacted much the use of steroids. And we do strongly believe that a gamma ray is steroid of choice.

Richard Daley, President and CEO, Catalyst Pharmaceuticals: Will, do you want to jump in there on the clinical?

Will Andrews, Chief Medical Officer, Catalyst Pharmaceuticals: Happy to Rich. Thank you. We see the new additions to the NCCN guidelines as critical to help you.

Richard Daley, President and CEO, Catalyst Pharmaceuticals: Is this for Alevides? For DMD?

Will Andrews, Chief Medical Officer, Catalyst Pharmaceuticals: Yes, I’m sorry. And the second question was NCCN. Yes. Alevitus, would add medically that I agree with Jeff from the perspective of that being an entirely different modality of treatment. And as Jeff said, it’s unfortunate as to what’s happened, but we still see of course corticosteroids and vimolaron as foundational treatment for these kids that is unaffected, we believe by what’s happened with Alevitas.

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 and that amifampridine is a critical option for them in the treatment.

Richard Daley, President and CEO, Catalyst Pharmaceuticals: 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, 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. 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, Chief Commercial Officer, Catalyst Pharmaceuticals: Thanks Rich. And Jason to your question, when do we expect this to hit commercial 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 converting some of these diagnosed patients onto Firdapse therapy. Hopefully

Richard Daley, President and CEO, Catalyst Pharmaceuticals: Thanks that Jason. Yes. Thank you. Thanks Jason.

Conference Operator: Thank you. The next question we have comes from Leland Gershell of Oppenheimer and Co. Please go ahead.

Leland Gershell, Analyst, Oppenheimer and Co: Great. Good morning and thanks for taking our questions. Just one from us, just on OpEx, maybe for Michael. Just wondering, given the realignment in the sales for Firdapse and Agamry affected a few months ago, just wondering how you see SG and 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, any increase into the second half? Thank you.

Mike Kalb, Chief Financial Officer, Catalyst Pharmaceuticals: Thanks, Leland. Hope all is well. So as you know, we did not quantify SG and A guidance. 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.

Leland Gershell, Analyst, Oppenheimer and Co: Okay, great. Thanks for taking the question.

Jeffrey Del Carmen, Chief Commercial Officer, Catalyst Pharmaceuticals: Thanks, Leo.

Conference Operator: Thank you. The next question we have comes from Luke Hellman of Baird. Please go ahead.

Luke Hellman, Analyst, Baird: Hi, 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. 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 in The US and Canada, and I think you’ve had a process underway to consider addition of third party manufacturers for a GAMRI. I guess has there been any recent evolution in thinking around the manufacturing strategy?

Richard Daley, President and CEO, Catalyst Pharmaceuticals: Thanks Luke. Thanks for the questions. So 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 2024. We believe and we see it the natural cadence of Firdapse returning post June 2024. And now we believe that effect is washed through the system.

So 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, we mentioned that we saw it the day it began to happen. So we were able to take rapid action. So 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. And we feel really well protected there. And you are also correct on working with third party manufacturers for a GammaRium transitioning that to The U. S. And we were working on that well before this current administration came into play.

So 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 plant. But we feel really good about the opportunity to shield that from tariffs as well mid in to long term because of the ability to move it to The U. S.

Leland Gershell, Analyst, Oppenheimer and Co: Great. Thank you.

Richard Daley, President and CEO, Catalyst Pharmaceuticals: Thanks Luke.

Conference Operator: Thank you. The next question we have comes from Jennifer Kim of Cantor. Please go ahead.

Jennifer Kim, Analyst, Cantor: Hi, good morning. Thanks for taking my question. Maybe to start with Firdapse. Are there any or 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? Then anything you can say about discontinuation rates for the quarter?

Richard Daley, President and CEO, Catalyst Pharmaceuticals: Jeff, do want take that?

Jeffrey Del Carmen, Chief Commercial Officer, Catalyst Pharmaceuticals: Sure. Thanks, Rich. And yes, the first I’ll answer the discontinuation rates. Discontinuation rates were below 20%, the annual discontinuation rate 20% for Firdapse. So, hopefully, were you asking about, Jennifer, were you asking about Firdapse specifically on discontinuation?

Jennifer Kim, Analyst, Cantor: Yeah.

Jeffrey Del Carmen, Chief Commercial Officer, Catalyst Pharmaceuticals: Okay. So less than 20% annual discontinue And what was your first question again? Dose. The dose. So since the label expansion in June, we have seen significant increase to the average daily dose, approximately about four milligrams, which is what we had expected.

So we the dose is performing according to what we had expected.

Jennifer Kim, Analyst, Cantor: 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 one hundred day exclusivity? And I asked because I wonder whether guidance could prove to be on the conservative side for that product.

Richard Daley, President and CEO, Catalyst Pharmaceuticals: Teva is the only player in the space right now for generic. They have one hundred and eighty day exclusivity. As to whether or not the guidance is too conservative, So far as we mentioned in the call, we’ve booked $70,000,000 in sales. Our guidance is 90,000,000 to $95,000,000 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 they have we have not seen them yet.

And so we’re taking what we believe is a prudent position for the balance of the year. And we will expect generic additional generic competitors by mid December. And as you know Jennifer sometimes they can load the channel into November and so that could affect our ex factory sales. So we believe this is a prudent approach to the forecast.

Jennifer Kim, Analyst, Cantor: Okay. That’s helpful. All Thanks guys.

Richard Daley, President and CEO, Catalyst Pharmaceuticals: Sure. Thank you.

Conference Operator: Thank you. The next question we have comes from Saddam Loguchan of Stephens Inc. Please go ahead.

Mike Kalb, Chief Financial Officer, Catalyst Pharmaceuticals0: Thanks. Good morning, Catalyst Pharma 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 PTCTs Translarna FDA approval for DMD treatment to affect how EXOMRI 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 Fycompos LOE? Are there any ongoing discussions with potential partners regarding a commercial stage asset or a late stage pipeline asset?

Richard Daley, President and CEO, Catalyst Pharmaceuticals: Think appropriate to turn that to Jeff for the first part.

Jeffrey Del Carmen, Chief Commercial Officer, Catalyst Pharmaceuticals: Yes, Soudan. Just like similar to Elevitus, the way we look at this is a gamma ray and steroids are the

Richard Daley, President and CEO, Catalyst Pharmaceuticals: foundation of

Jeffrey Del Carmen, Chief Commercial Officer, Catalyst Pharmaceuticals: treatment. Translarna does not impact that at all. So we just continue to feel strongly about a gamma ray’s potential moving forward because we do believe it is the best and differentiated steroid out there for boys living with DMD. And as far as Well, I’m sorry, Sudhak, could you

Richard Daley, President and CEO, Catalyst Pharmaceuticals: just repeat your question? I lost you for a second. Repeat your second question.

Mike Kalb, Chief Financial Officer, Catalyst Pharmaceuticals0: Yes. So the second one was just on your current stance on the near term strategic initiatives to offset the FiComp LOE. If there’s any ongoing discussions with the other 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 Daley, President and CEO, Catalyst Pharmaceuticals: Thanks for clarifying. So 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 fifteen or twenty years.

And our team is assessing multiple opportunities at any point in time. And as mentioned on previous calls, we continue to see 80% of the opportunities coming to us inbound. So other companies will approach us or other parties will approach us about opportunities. So we’re really excited about building continuing to build a portfolio. In addition to that, a second pillar of our business is lifecycle management.

And when we talk about the opportunity around a gamma ray 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. And 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.

Mike Kalb, Chief Financial Officer, Catalyst Pharmaceuticals0: I appreciate that. Thank you.

Richard Daley, President and CEO, Catalyst Pharmaceuticals: Thank you.

Conference 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.

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