Q3 2025 Catalyst Pharmaceuticals Inc Earnings Call

November 6, 2025

[music].

Operator: Greetings, welcome to the Catalyst Pharmaceuticals Q3 2025 financial results conference call and webcast. At this time, all participants are in a listen-only mode. A question-and-answer session will follow a formal presentation. You may be placed into question queue at any time by pressing star 1 on your telephone keypad. We ask that you please ask 1 question, 1 follow-up, then return to the queue. If anyone should require operator assistance, please press star 0. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Chief Financial Officer Michael Kalb. Mike, please go ahead.

Greetings and welcome to the catalyst Pharmaceuticals third quarter 2025 financial results conference call and webcast at.

At this time all participants are in a listen only mode.

And answer session will follow the formal presentation.

Place into questions any time by pressing star one on your telephone keypad.

We ask you. Please ask one question and one follow up then return to the queue.

And once you require operator assistance. Please press Star Zero as a reminder, this conference is being recorded.

Pleasure to turn the call over to Chief Financial Officer, Mike <unk>, Mike. Please go ahead.

Michael Kalb: Thank you. Good morning, everyone. Thank you for joining our conference call to discuss Catalyst's Q3 2025 Financial Results and Business Highlights. Richard Daly, President and CEO, will lead the call today. Jeffrey Del Carmen, our Chief Commercial Officer, and I will also present. Additionally, Dr. Stephen 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. They do not guarantee future performance. They involve risks, uncertainties, and assumptions that are difficult to predict and may not prove to be accurate.

Thank you good morning, everyone and thank you for joining our conference call to discuss catalysts third 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, doctors Stephen Miller, our Chief operating Officer, and Chief Scientific Officer, and Doctor 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.

Michael Kalb: They 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 the 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 26 February 2025, and in our subsequent filings with the SEC, including our Q3 2025 quarterly report on Form 10-Q, which was filed yesterday, 5 November 2025, with the SEC. At this time, I'll turn the call over to Rich. Rich?

They involve risks uncertainties and assumptions that are difficult to predict and may not prove to be accurate.

Michael Kalb: Actual results may vary from the expectations contained in our forward-looking statements. These forward-looking statements should be considered only in conjunction with the detailed information contained in our SEC filings, including the risk factors described in our 2024 annual report on Form 10-K filed with the SEC on 26 February 2025, and in our subsequent filings with the SEC, including our Q3 2025 quarterly report on Form 10-Q, which was filed yesterday, 5 November 2025, with the SEC. At this time, I'll turn the call over to Rich. Rich?

Actual results may vary from the expectations contained in our forward looking statements.

These forward looking statements should be considered only in conjunction with the detailed information contained in our SEC filings, including the risk factors described in our 2024 annual report on Form 10-K filed with the SEC on February 26 2025.

And in our subsequent filings with the SEC, including our third quarter 2025 quarterly report on Form 10-Q, which was filed yesterday November November 5th 2025 with the SEC.

At this time I'll turn the call over to rich rich.

Richard Daly: Thanks, Michael Kalb. Good morning, everyone. Thank you for joining us. Today's call will begin with an overview of our portfolio highlights and key strategic growth initiatives, followed by a detailed discussion of our commercial performance and financial results for the quarter. Catalyst Pharmaceuticals delivered outstanding Q3 2025 results with accelerating momentum, strong demand for our rare disease therapies, and continued progress on key strategic growth priorities. These results highlight our growing positive impact on the patient communities we serve and demonstrate our unwavering commitment to operational excellence and delivering long-term value. Catalyst Pharmaceuticals reported another record quarter in Q3 2025, with total revenue reaching $148.4 million, an increase of 15.3% year-over-year. These results were driven primarily by outstanding performance of FIRDAPSE and the growing success of AGAMREE, along with extended patient preference for FYCOMPA following generic entry.

Thanks, Mike.

Good morning, everyone and thank you for joining us.

Today's call will begin with an overview of our portfolio highlights and key strategic growth initiatives, followed by a detailed discussion of our commercial performance and financial results for the quarter.

Catalysts delivered outstanding third quarter, 'twenty twenty-five results with accelerating momentum strong demand for our rare disease therapies and continued progress on key strategic growth priorities.

These results highlight our growing positive impact on the patient communities, we serve and demonstrate our unwavering commitment to operational excellence and delivering long term value.

Catalysts reported another record quarter in Q3, 2025, with total revenue, reaching $148 4 million.

An increase of 15, 3% year over year. These.

These results were driven primarily by outstanding performance at Ford apps, and the growing success of our Gambia.

Along with extended patient preference for Fi copper following generic entry.

Richard Daly: We ended Q3 2025 with a cash position of $689.9 million and no debt, further reinforcing our ability to invest strategically for long-term growth. Last month, we announced that our Board of Directors authorized a new share buyback program to repurchase up to $200 million of shares of Catalyst outstanding common stock between 1 October 2025 and 31 December 2026. As mentioned, we believe that we can execute this share repurchase program without impairing the advancement of our business development strategy. Further, we believe that this repurchase program will enable us to provide value to our shareholders, and we are increasingly confident in our long-term outlook. With our strong performance over the first three quarters of the year, we are raising our 2025 total revenue guidance to between $565 million and $585 million. Let's start with FIRDAPSE.

We ended the third quarter of 2025, with a cash position of $689 $9 million and no debt further reinforcing our ability to invest strategically for long term growth.

Last month, we announced that our board of directors authorized a new share buyback program to repurchase up to $200 million of shares of catalyst outstanding common stock between October 1st 2025, and December 31 2026.

As mentioned, we believe that we can execute this share repurchase program without impairing the advancement of our business development strategy.

Further we believe that this repurchase program will enable us to provide value to our shareholders and we are increasingly confident in our long term outlook.

With our strong performance over the first three quarters of the year, we are raising our 2025 total revenue guidance to between $565 million and $585 million.

Let's start with first apps.

Richard Daly: FIRDAPSE continues to demonstrate outstanding performance, maintaining its position as the only evidence-based approved product in the U.S. for the treatment of Lambert-Eaton myasthenic syndrome. The brand delivered another strong quarter of sustained growth, generating revenue of $92.2 million and an increase of 16.2% year-over-year. We are confident that FIRDAPSE remains well-positioned for sustained organic growth across both idiopathic and Cancer-Associated LEMS markets, supported by a robust pool of patients and individuals progressing through their diagnostic journey. This strong and visible demand underscores the durability of the franchise and reinforces our leadership in addressing the needs of the LEMS community. Jeff will go into more detail about our growth strategy in these distinct markets in his remarks. 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.

Bert apps continues to demonstrate outstanding performance, maintaining its position as the only evidence based approved product in the U S for the treatment of Lambert Eaton Myasthenic syndrome.

The brand delivered another strong quarter of sustained growth generating revenue of $92 $2 million, an increase of 16, 2% year over year.

We are confident that <unk> remains well positioned for sustained organic growth across both idiopathic and cancer associated lambs markets.

Supported by a robust pool of patients individuals' progressing through their diagnostic journey.

The strong and visible demand underscores the durability of the franchise and reinforces our leadership in addressing the needs of the lens community.

Jeff will go into more detail about our growth strategy in these.

Stink markets in his remarks.

Richard Daly: Since we believe that potentially 90% of Cancer-Associated LEMS patients remain undiagnosed, we see a meaningful opportunity to expand our reach in this high-potential underserved population.

Since we believe that potentially 90% of cancer associated lens patients remained on diagnosed we see a meaningful opportunity to expand our reach in this high potential underserved population.

Richard Daly: We expect momentum to build in the months ahead, setting the stage for sustained growth in 2026 and beyond. We remain confident that we will meet our full-year total net product revenue guidance for FIRDAPSE of between $355 million and $360 million. Jeff will cover the specifics in his section of the call. Moving on to AGAMREE. While FIRDAPSE continues to perform incredibly well, we're equally encouraged by the market potential and performance of AGAMREE. AGAMREE continues to outperform expectations, generating $32.4 million in net product revenue in Q3 2025, a 115.2% increase year-over-year from Q3 2024. These results are largely driven by steady conversion from both prednisone and EMFLAZA, a strong 90% patient retention rate, and growing adoption across virtually all of the DMD centers of excellence around the United States.

We expect momentum to build in the months ahead and setting the stage for sustained growth in 2026 and beyond.

We remain confident that we'll meet our full year total net product revenue guidance for Ford apps are between $355 million and $360 million.

Jeff will cover the specifics in his section of the call.

Moving onto a gamut.

Well first apps continues to perform incredibly well, we're equally encouraged by the market potential and performance of the gallery.

<unk> continues to outperform expectations generating $32 $4 million in net product revenue in Q3 2025.

A 115.2% increase year over year from Q3 2024.

These results are largely driven by steady conversion from both prednisone and in Florida.

Our strong 90% patient retention rate and growing adoption across virtually all of the D. M D centers of excellence around the United States.

Richard Daly: AGAMREE's commercial execution continues to track well with strong patient retention and increasing prescriber engagement, further supported by recent full deployment of our dedicated field team back in April. Continued transitions from both branded and generic therapies, along with growing market receptivity and payer alignment due to an increased appreciation for AGAMREE's potential differentiation from the current standard of care, reinforce our confidence in raising full-year outlook to between $105 million and $115 million. Catalyst continues to actively enroll patients in the SUMMIT study, an open-label five-year follow-up study designed to evaluate the long-term clinical safety profile of AGAMREE, including potential benefits on behavior, stature, bone health, and cardiovascular health. Finally, let's take a look at FYCOMPA. FYCOMPA delivered higher-than-anticipated results in Q3 2025 with revenue of $23.8 million, which reflects a year-over-year decrease of 25.8%.

Our Gam res commercial execution continues to track well with strong patient retention and increasing prescriber engagement.

Further supported by recent full deployment of our dedicated field team back in April.

Continued transitions from both branded and generic therapies, along with growing market receptivity and payer alignment due to an increased depreciation for a gary's potential differentiation from.

From the current standard of care reinforce our confidence in raising full year outlook to between 105 and $115 million.

Catalyst continues to actively enroll patients in the summit study an open label five year follow up study designed to evaluate the long term clinical safety profile of the Gary including potential benefits on behavior stature bone health and cardiovascular health.

Finally, let's take a look at Phi Kappa.

My comp of delivered higher than anticipated results in the third quarter of 2025 with revenue of $23 $8 million.

Which reflects a year over year decrease of 25, 8%.

Richard Daly: This performance was driven in part by patients electing to stay on their existing treatment plan following generic entry for FYCOMPA tablets in Q2 2025. Although we anticipate the impact of generic entry to increase going forward as other entrants eventually come to the market, we are raising our full-year net product revenue guidance for this product to between $100 million and $110 million. Now I'd like to reiterate what we believe sets us apart. Catalyst's competitive advantage is built on the strength of not only our field efforts from both our sales and medical teams, but also our patient engagement services that we offer through Catalyst Pathways for patients taking FIRDAPSE and AGAMREE.

This performance was driven in part by patients electing to stay on their existing treatment plan. Following generic entry for Fi copper tablets in Q2 2025.

Although we anticipate the impact of generic entry to increase going forward as other entrants eventually come to the market.

We are raising our full year net product revenue guidance for this product to between 101 hundred $10 million.

Now I'd like to reiterate what we believe sets us apart.

Catalysts competitive advantage is built on the strength of not only our field efforts from both our sales and medical teams, but also our patient engagement services that we offer through catalyst pathways for patients, taking <unk> and <unk>.

Richard Daly: Catalyst Pathways is our personalized treatment support program for patients who are enrolled in the program and serves as a single source for personalized treatment support, education, and guidance to the dosing and titration regimen required to reach an effective therapeutic dose for each patient's therapy. We believe that navigating the healthcare system with this support is far better for patients needing treatment for their rare diseases and for the healthcare community in general. Finally, our strong relationship with healthcare and rare disease communities continues to drive meaningful stakeholder engagement. Together, our single-source approach enables the patients we serve to streamline access, identify appropriate therapy, receive timely treatment, and remain compliant with their care. We believe these differentiating capabilities will enhance prospects for creating uncommon value for our current patients and for other rare disease patients in the future. Let's turn to business development.

Catalyst pathways is our personalized treatment support program for patients who are enrolled in the program and serves as a single source for personalized treatment support education and guidance, the dosing and titration regimen required to reach an effective therapeutic dose for each patient therapy.

We believe that navigating the health care system with this support is far better for patients needing treatment for their rare diseases and for the health care community in general.

Finally, our strong relationship with health care and rare disease communities continues to drive meaningful stakeholder engagement.

Together, our single source approach enables the patients we serve to streamline access identify appropriate therapy.

Receive timely treatment and remain compliant with their care.

We believe these differentiate Kate differentiating capabilities will enhance.

Prospects for creating uncommon value for our current patients and for other rare diseases patients in the future.

Richard Daly: Let's turn to business development. We remain highly disciplined in our business development strategy, we continue to actively evaluate a broad range of opportunities, many of which are inbounds, reflecting growing awareness of the value we create for patients in need. We also have an aggressive outreach initiative resulting in over 100 assessments since January. The support services that we have developed through Catalyst Pathways for patients who are taking FIRDAPSE and AGAMREE are industry-leading and can be applied to any rare therapeutic area, we remain therapeutic area agnostic.

Let's turn to business development.

Richard Daly: We remain highly disciplined in our business development strategy, we continue to actively evaluate a broad range of opportunities, many of which are inbounds, reflecting growing awareness of the value we create for patients in need. We also have an aggressive outreach initiative resulting in over 100 assessments since January. The support services that we have developed through Catalyst Pathways for patients who are taking FIRDAPSE and AGAMREE are industry-leading and can be applied to any rare therapeutic area, we remain therapeutic area agnostic. We believe our integrated infrastructure with our sales teams identifying potential patients and Catalyst Pathways providing direct support to patients, getting the patients on therapy, keeping them on therapy, and ensuring the patient receives the optimum dose are important components of our continued success and our core capabilities that we see as not universally available through other companies serving patients living with rare diseases.

We remain highly disciplined in our business development strategy and we continue to actively evaluate a broad range of opportunities many of which are inbounds.

Reflecting growing awareness of the value we create for patients in need.

We also have an aggressive outreach initiative, resulting in over 100 assessments since January.

The support services that we have developed through catalyst pathways for patients who are taking Fedex and a gallery are industry, leading and can be applied to any rare therapeutic area.

So we remain therapeutic area agnostic.

Richard Daly: We believe our integrated infrastructure with our sales teams identifying potential patients and Catalyst Pathways providing direct support to patients, getting the patients on therapy, keeping them on therapy, and ensuring the patient receives the optimum dose are important components of our continued success and our core capabilities that we see as not universally available through other companies serving patients living with rare diseases. Now for an update on IP.

We believe our integrated infrastructure with our sales teams identifying potential patients and catalyst pathways, providing direct support to patients.

Getting the patients on therapy, keeping them on therapy, and ensuring the patient receives the optimum dose are important components of our continued success and our core capabilities that we see is not universally available through other companies serving patients living with rare diseases.

Richard Daly: Now for an update on IP. We continue to advance initiatives to protect long-term value for our portfolio. On 26 August, we announced the settlement of our pending FIRDAPSE patent litigation with Lupin. As part of the settlement, Lupin received a license to market generic FIRDAPSE beginning in February 2035, on the same market entry date as Teva Pharmaceuticals had previously agreed to in their settlement. This settlement leaves only one patent case still pending against Hetero USA, Inc. The trial date has been set for March 2026, which is prior to the expiration of the automatic 30-month stay set for 26 May 2026. I'd like to reiterate my previous comment. As we have consistently stated, we will vigorously defend our IP for all of our products. With that, I'll turn the call over to Jeff, who can provide additional insights into our commercial performance. Jeff?

Now for an update on IP.

Richard Daly: We continue to advance initiatives to protect long-term value for our portfolio. On 26 August, we announced the settlement of our pending FIRDAPSE patent litigation with Lupin. As part of the settlement, Lupin received a license to market generic FIRDAPSE beginning in February 2035, on the same market entry date as Teva Pharmaceuticals had previously agreed to in their settlement. This settlement leaves only one patent case still pending against Hetero USA, Inc. The trial date has been set for March 2026, which is prior to the expiration of the automatic 30-month stay set for 26 May 2026. I'd like to reiterate my previous comment. As we have consistently stated, we will vigorously defend our IP for all of our products. With that, I'll turn the call over to Jeff, who can provide additional insights into our commercial performance. Jeff?

We continue we'll continue to advance initiatives to protect long term value for our portfolio.

On August 26th we announced the settlement of our pending for <unk> patent litigation with Lupin.

As part of the settlement Lupin received a license to market generic ferd apps beginning in February of 2035.

On the same market entry date as Teva pharmaceuticals.

Previously agreed to in their settlement.

This settlement leaves only one patent case still pending against Hetero USA incorporated.

The trial date has been set for March of 2026, which is prior to the expiration of the automatic 30 month stay.

Set for May 26 of 2026.

I'd like to reiterate my previous comment as we have consistently stated we will vigorously defend our IP for all of our products.

With that I'll turn the call over to Jeff can provide additional insights into our commercial performance Jeff.

Jeffrey Del Carmen: Thanks, Rich. Q3 2025 marked another record-setting quarter for our commercial organization, generating net product revenue of $148.4 million, a 17.4% increase compared to Q3 2024. These results highlight continued strong execution across our portfolio and sustained demand for our differentiated therapies. As Rich noted, Catalyst Pharmaceuticals again delivered organic growth from FIRDAPSE, continued adoption of AGAMREE, and stronger-than-expected revenue from FYCOMPA. Our Q3 2025 net product revenue underscores the strength and resilience of our rare disease platform. FIRDAPSE continues to deliver sustained organic growth. Q3 2025 revenue results of $92.2 million reflect its robust growth trajectory, driven by durable demand and continued execution of our growth strategy, resulting in 16.2% growth in Q3 2025 compared to Q3 2024. New patient enrollments exceeded forecast. 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%.

Thanks, Rich Q3, 2025 marked another record setting quarter for our commercial organization generating net product revenue of $148 4 million, a 17, 4% increase compared to Q3 2024.

These results highlight continued strong execution across our portfolio and sustained demand for our differentiated therapies.

As rich noted catalyst again delivered organic growth from bird apps continued adoption of our gamergate in stronger than expected revenue from by copper.

Our Q3 2025 net product revenue underscores the strength and resilience.

Our rare disease platform.

<unk> continues to deliver sustained organic growth Q3, 2025 revenue results of 92.2 million reflect its robust growth trajectory driven by durable demand and continued execution of our growth strategy, resulting in 16.

0.2% growth in Q3, 2025 compared to Q3 2024.

New patient enrollments exceeded forecast 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%.

Jeffrey Del Carmen: 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%.

Jeffrey Del Carmen: These indicators reflect strong patient adherence and reinforce the foundation for sustained performance. Leading indicators, including new patient starts and refill volumes through October, continue to trend positively, reinforcing our confidence in achieving our full-year 2025 FIRDAPSE net product revenue guidance of between $355 million and $360 million. Our next phase of growth for FIRDAPSE will come from both idiopathic LEMS and Cancer-Associated LEMS. For idiopathic LEMS, we continue to advance our patient identification efforts by augmenting data sources, further expanding the pool of over 500 LEMS patients in active diagnostic stages. With a dedicated sales force of 16 Regional Account Managers and enhanced lead optimization efforts that better target patients most likely to initiate FIRDAPSE treatment, these patients now represent over 50% of new starts each quarter, strengthening our confidence in sustaining future organic growth.

These indicators reflect strong patient adherence and reinforce the foundation for sustained performance.

Leading indicators, including new patient starts and refill volume through October continue to trend positively reinforcing our confidence in achieving our full year 2025 third apps net product revenue guidance of between $355 million and $360 million.

Our next phase of growth for <unk> will come from both idiopathic lens and cancer associated labs.

For idiopathic lens, we continued to advance our patient identification efforts by augmenting data sources further expanding the pool of over 500 lens patients and active diagnostic stages.

With a dedicated sales force of 16 regional account managers and enhance lead optimization efforts that better target patients most likely to initiate <unk> treatment.

These patients now represent over 50% of new starts each quarter strengthening our confidence in sustaining future organic growth.

Jeffrey Del Carmen: In addition, we have intensified efforts to expand VGCC antibody testing among patients often misdiagnosed with myasthenia gravis, which remains the most common misdiagnosis for LEMS patients. We have seen sustained VGCC antibody testing growth of 9% quarter-over-quarter over the last 2 years. With only approximately 30% penetration on the idiopathic side of the LEMS market opportunity, we have clearly identified the potential sustainable growth. Our expansion strategy for Cancer-Associated LEMS is sharply focused on multiple critical levers, broadening access to VGCC antibody testing and streamlining the diagnostic pathway, now further reinforced by the recent NCCN Small Cell Lung Cancer Guidelines update on 25 July, and our efforts to update the oncology care pathways and expanding HCP education on those updated pathways. As Rich mentioned, we are continuing to execute on those fronts.

In addition, we have intensified efforts to expand D. G. C. C antibody testing among patients often misdiagnosed with myasthenia gravis, which remains the most common misdiagnosis for lens patients. We have seen sustained D. G. C C antibody testing growth of 9%.

Quarter on quarter over the last two years with only approximately 30% penetration on the idiopathic side of the lens market opportunity, we have clearly identified the potential sustainable growth.

Our expansion strategy for cancer associated lens is sharply focused on multiple critical levers broadening access to BGC antibody testing and streamlining the diagnostic pathway now further reinforced by the recent N C. C N small cell lung cancer guideline.

On July 25th.

And our efforts to update the oncology care pathways and expanding H C. P education on those updated pathways as rich mentioned, we are continuing to execute on those fronts.

Jeffrey Del Carmen: First, we have launched a frictionless testing model designed to remove referral bottlenecks and accelerate the time to diagnosis. Second, the updated NCCN Guidelines now include VGCC antibody testing and recommend amifampridine, the only evidence-based approved treatment for patients with LEMS, potentially providing a strong tailwind for market adoption. Third, we are pursuing new collaborations with leading oncology networks to integrate these updated NCCN Guidelines into their care pathways. Lastly, we continue to expand our footprint across the community to educate those concentrated oncology centers on the updated care pathways. With over 90% of Cancer LEMS patients still undiagnosed, the unmet need remains significant. We see a clear opportunity to drive awareness, increase access, and deliver meaningful impact across the LEMS community. As we move forward, we're executing with precision to accelerate diagnosis, increase adoption, and position FIRDAPSE for sustained momentum through 2026 and beyond. Turning to AGAMREE.

First we have launched a frictionless testing model designed to remove referral bottlenecks and accelerate their time to diagnosis.

Second the updated and N C. C. N guidelines now include D. G. C C antibody testing and recommend and Sam pretty the only evidence based approved treatment for patients with lens potentially providing a strong tailwind for market adoption.

Third we are pursuing new collaborations with leading oncology networks to integrate these updated mtc and guidelines into their care pathways.

Lastly, we continue to expand our footprint across the community to educate those concentrated oncology centers on the updated care pathways.

With over 90% of cancer patients still on diagnosed the unmet need remains significant and we see a clear opportunity to drive awareness increase access and deliver meaningful impact across the lender community.

Jeffrey Del Carmen: As we move forward, we're executing with precision to accelerate diagnosis, increase adoption, and position FIRDAPSE for sustained momentum through 2026 and beyond. Turning to AGAMREE.

As we move forward, we're executing with precision to accelerate diagnosis increase adoption and position <unk> for sustained momentum through 2026 and beyond.

Turning to a gambling.

Jeffrey Del Carmen: AGAMREE continues to demonstrate strong market momentum as a differentiated therapy for Duchenne muscular dystrophy. In Q3 2025, we generated net product revenue of $32.4 million, a 115.2% increase over Q3 2024. Adoption is expanding steadily across key treatment centers. To date, each of the top 45 DMD centers of excellence have enrolled at least one patient on AGAMREE, and 255 unique healthcare providers have submitted enrollment forms, reflecting broad and growing engagement across the community. Since launch, approximately 43% of patients being treated with AGAMREE transitioned from prednisone and 41% from EMFLAZA, highlighting AGAMREE's broad clinical relevance across established treatment segments. Reimbursement performance remains robust, with success rates above 85%, in line with our expectations. Our commercial team continues to execute effectively, driving targeted provider education and deepening payer engagement to support durable uptake and sustained market expansion.

<unk> continues to demonstrate strong market momentum as a differentiated therapy for duchenne muscular dystrophy in.

In the third quarter of 2025, we generated net product revenue of $32 4 million, a 115, 2% increase over the third quarter of 2020 for adoption.

Adoption is expanding steadily across key treatment centers to date each of the top 45 DMD centers of excellence have enrolled at least one patient on a gallery and 255 unique health care providers have submitted enrollment forms, reflecting broad and growing engagement across the commute.

City.

Since launch approximately 43% of patients being treated with <unk> transitioned from prednisone and 41% from N Plaza, highlighting a gambler is broad clinical relevance across established treatment segments.

Reimbursement performance remains robust with success rates above 85% in line with our expectations. Our commercial team continues to execute effectively driving targeted provider education and deepening payer engagement to support durable uptake it's sustained market.

Spansion.

Jeffrey Del Carmen: Given the continued strength of these trends, we are raising our full-year net product revenue guidance for AGAMREE to a range of between $105 million and $115 million. Finally, FYCOMPA delivered Q3 2025 net product revenue of $23.8 million, reflecting continued demand following the first generic entry for tablets in late May. We remain cautiously optimistic on FYCOMPA brand loyalty and, based on stronger-than-expected performance in the first nine months, we are raising full-year 2025 FYCOMPA revenue guidance to between $100 million and $110 million. As previously noted, we do expect continued revenue erosion from generic competition to impact FYCOMPA performance in Q4 and beyond as more generics enter the market. In summary, our commercial team continues to execute with strong discipline and focus, delivering robust portfolio performance and advancing our next phase of growth.

Given the continued strength of these trends we are raising our full year net product revenue guidance for a gamergate to a range of between $105 million and $115 million.

Finally by Champa delivered Q3, 2025, net product revenue of $23 8 million.

Reflecting continued demand following the first generic entry for tablets in late May we.

We remain cautiously optimistic on buy copper brand loyalty and based on stronger than expected performance in the first nine months, we are raising full year 2025 by copper revenue guidance to between 101 hundred $10 million.

As previously noted we do expect continued revenue erosion from generic competition to impact by copper performance in Q4 and beyond as more generics enter the market.

In summary, our commercial team continues to execute with strong discipline and focus delivering robust portfolio performance and advancing our next phase of growth. We are confident that our diversified portfolio best in class commercial capabilities and focused execution position us well.

Jeffrey Del Carmen: We are confident that our diversified portfolio, best-in-class commercial capabilities, and focused execution position us well to capture the significant growth opportunities ahead. As we look to close 2025, our priorities remain clear: driving commercial excellence, broadening patient access, and maximizing the value of our portfolio to deliver sustainable growth and long-term shareholder value. I would like to thank the entire Catalyst team for their continued dedication and commitment to performance, execution, and the patients we serve. At this time, I would like to turn the call back over to Mike.

To capture the significant growth opportunities ahead.

As we look to close 2025, our priorities remain clear.

Driving commercial excellence.

Broadening patient access and maximizing the value of our portfolio to deliver sustainable growth and long term shareholder value.

I would like to thank the entire catalyst team for their continued dedication and commitment to performance execution and the patients we serve.

At this time I would like to turn the call back over to Mike.

Michael Kalb: Thank you, Jeff. Our performance during Q3 2025 has kept us on pace for another strong year, driven by our solid financial performance, financial discipline, and strong execution. Our total revenues for Q3 2025 were $148.4 million, an approximate 15.3% increase when compared to total revenues of $128.7 million for Q3 2024. Q3 2024 included approximately $2.3 million of license and other revenue, which consisted principally of a milestone payment that we earned from our sublicensee, DyDo Pharma, upon its receiving regulatory approval to commercialize FIRDAPSE for the treatment of patients with LEMS in Japan, compared to license and other revenue in Q3 2025 of $27,000.

Thank you, Jeff our performance during the third quarter of 2025 has kept us on pace for another strong year, driven by our solid financial performance financial discipline and strong execution.

Our total revenues for the third quarter of 2025 were $148 $4 million and approximately 15, 3% increase when compared to total revenues of $128 $7 million for the third quarter of 2024.

The third quarter of 2024 included approximately $2 $3 million of license and other revenue, which consisted principally of a milestone payment that we earned from our Sublicensee that'll pharma.

Upon receiving regulatory approval to commercialize <unk> for the treatment of patients with <unk> in Japan compared to license and other revenue in the third quarter of 2025 of $27000.

Michael Kalb: Net income before income taxes for Q3 2025 were $71.0 million, a 24.2% increase year-over-year compared to $57.2 million for Q3 2024. We reported GAAP net income for Q3 2025 of $52.8 million, or $0.42 per diluted share. GAAP net income increased by 20.3% year-over-year compared to GAAP net income for Q3 2024 of $43.9 million, or $0.35 per diluted share. Non-GAAP net income for Q3 2025 was $86.1 million, or $0.68 per diluted share, which excludes firm 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 $5.7 million, the income tax provision of $18.3 million, and depreciation of $100,000.

Net income before income taxes for the third quarter of 2025 or 71.0 million.

24, 2% increase year over year compared to $57 2 million for the third quarter of 2024.

We reported GAAP net income for the third quarter of 2025 of $52 8 million or <unk> 42 cents per diluted share.

GAAP net income increased by 23% year over year compared to GAAP net income for the third quarter of 2024 of.

$43 9 million or <unk> 35 per diluted share.

non-GAAP net income for the third quarter of 2025 was $86 $1 million or <unk> 68 per diluted share, which excludes from GAAP net income.

Amortization of intangible assets related to our acquisitions of copper a gallery and reserves.

Of $9 3 million stock based compensation expense of $5 $7 million, the income tax provision of $18 3 million and depreciation of $100000.

Michael Kalb: This compares to Non-GAAP net income for Q3 2024 of $71.1 million, or $0.57 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 $13.3 million, and depreciation of $100,000. Our year-to-date effective tax rate through the first nine months of 2025 was 23.6% compared to 24.0% through the first nine months 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 $22.7 million in Q3 2025 compared to $19.3 million in Q3 2024 and consisted principally of royalties.

This compares to non-GAAP net income for the third quarter of 2024 of $71 $1 million or <unk> 57 per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of <unk> and reserves of $9 3 million.

Stock based compensation expense of $4 $4 million, the income tax provision of $13 $3 million and.

<unk> of $100000.

Our year to date effective tax rate through the first nine months of 2025 was 23, 6% compared to 24.0% through the first nine months of 2024.

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 $22 $7 million in the third quarter of 2025 compared to $19 $3 million in the third quarter of 2024 and consisted principally of royalties.

Michael Kalb: As a reminder, AGAMREE royalties paid to the product licensor equal 5% of net sales up to $100 million for 2025 and 7% of net sales in excess of $100 million and up to $200 million, with additional increases as net sales increase. The company is also required to make a $12.5 million sales-based milestone payment once AGAMREE's net product revenue for a fiscal year reaches $100 million. When this occurs, this milestone payment will be capitalized and amortized over the estimated remaining useful life of the asset. Further details on our royalty obligations for AGAMREE, as well as FIRDAPSE and FYCOMPA, are disclosed in our Q3 Form 10-Q. Research and development expenses were $2.7 million in Q3 2025 compared to $3.3 million in Q3 2024.

As a reminder, our gammy royalties paid to the product license or equal 5% of net sales up to $100 million for 2025, and 7% of net sales in excess of $100 million and up to $200 million.

With additional increases as net sales increase.

The company is also required to make a $12 5 million dollar sales based milestone payment once the <unk> net product revenue for fiscal year reaches $100 million.

When this occurs this milestone payment will be capitalized and amortized over the estimated remaining useful life of the asset.

Further details on our royalty obligations for Gary as well as fair at ups and fund comp are disclosed in our <unk>.

Third quarter Form 10-Q.

Research and development expenses were $2 $7 million in the third quarter of 2025 compared to $3 $3 million in the third quarter of 2024.

Michael Kalb: Our R&D spending in Q3 2025 was comprised mainly of costs to support our two ongoing AGAMREE studies. Selling general and administrative, or SG&A, expenses for Q3 2025 totaled $47.5 million as compared to $45.9 million in Q3 2024, reflecting in part an increase in our Cancer-Associated LEMS activities. As reported, we ended Q3 2025 with cash and cash equivalents of $689.9 million compared to $517.6 million at 31 December 2024. This increase in cash of $172.3 million between the end of 2024 and 30 September 2025, was largely driven by $163.8 million in cash generated from operations of the business. This highlights our continued focus on profit optimization and cash flow generation.

Our R&D spending in the third quarter of 2025 was comprised mainly of costs to support our two ongoing <unk> studies.

Selling general and administrative or SG&A expenses for the third quarter of 2025 totaled $47 $5 million as compared to $45 $9 million in Q3 2024.

Reflecting in part an increase in our cancer associated lenses activities.

As reported we ended the third quarter of 2025 with cash and cash equivalents of $689 9 million.

Compared to $517 6 million at December 31, 2024.

This increase in cash of $172 $3 million between the end of 'twenty four and September 32025.

It was largely driven by $163 $8 million in cash generated from operations of the business.

This highlights our continued focus on profit optimization and cash flow generation.

Michael Kalb: We believe our current funds, along with our expected continued generation of cash from operations, continue to allow us the financial flexibility to fund our existing R&D programs, meet our potential contractual obligations, and support our strategic initiatives, business development, and portfolio expansion efforts leading to long-term growth and value creation. More detailed information and analysis of our Q3 2025 financial performance may be found in our quarterly report on Form 10-Q, which was filed with the Securities and Exchange Commission yesterday, 5 November, and can be found on the Investor Relations web page of our website. At this time, I'll turn the call back over to Rich. Rich?

We believe our current funds along with our expected continued generation of cash from operations continued to allow us the financial flexibility to fund our existing R&D programs meet our potential contractual obligations and support our strategic initiatives and business development.

And portfolio expansion efforts, leading to long term growth and value creation.

More detailed information and analysis of our third 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 November five and.

And can be found on the Investor relations page of our website.

At this time I will turn the call back over to rich rich. Thanks, Mike as you heard on today's call catalysts is closing 2025 with strong momentum momentum and an unwavering commitment to deliver value for the patients we serve.

Richard Daly: Thanks, Mike. As you heard on today's call, Catalyst is closing 2025 with strong momentum and an unwavering commitment to deliver value for the patients we serve. This confidence is reflected in our updated guidance, which we raised after careful consideration and with respect to market conditions. This quarter's exceptional results reflect the strength of our commercial execution, the resilience of our business model, and the depth of talent across our organization. I want to thank our employees, partners, and shareholders for their continued support and dedication. As we finish 2025 with ongoing momentum, we look forward to continued success. Thank you for joining us on today's call, and I'll now turn the call back over to the operator for questions.

This confidence is reflected in our updated guidance, which we raised after careful consideration and with respect to market conditions.

This quarter's exceptional results reflect the strength of our commercial execution, the resilience of our business model and the depth of talent across our organization.

I want to thank our employees partners and shareholders for their continued support and dedication.

As we finished 2025 with ongoing momentum we look forward to continued success.

Thank you for joining us on today's call and I'll now turn the call back over to the operator for questions.

Operator: Thank you. We'll now be conducting a question-and-answer session. If you'd like to be placed in the question queue, please press star one on your telephone keypad. As a reminder, we ask that you please limit yourselves to one question and one follow-up, then return to the queue. If you'd like to move yourself from the queue, please press star two. A confirmation tone will indicate your line is in the question queue when you press star one. One moment, please, while we pull for questions. Our first question today is coming from Samantha Semenkow from Citigroup. Your line is now live.

Thank you well now be conducting a question and answer session if you'd like to be placed in the question queue. Please press star one on your telephone keypad.

As a reminder, we ask you please limit yourself to one question and one follow up then return to the queue, if you'd like to remove yourself from the queue. Please press star two.

A confirmation tone will indicate lives in the question queue. When you press star one.

One moment, please while we poll for questions.

Our first question today is coming from Smith Smith from Citigroup. Your line is now live.

Samantha Semenkow: Hi. Good morning. Thanks very much for taking our questions, and congratulations on the great quarter. First question is on FIRDAPSE. I'm wondering, as you start to penetrate and really put a lot of effort into the oncology portion of the LEMS business, are you able to share any anecdotes or data points that you have thus far that can really help us begin to quantify how those efforts are progressing? Then on FYCOMPA, do you have a sense of what proportion of the patients are expected to stay loyal to branded FYCOMPA? I'd be just trying to figure out as these additional generics come to the market how much erosion we're looking at for this Q4. Thanks very much.

Hello, Good morning, Thanks, very much for taking our question.

And then congratulations on the great quarter.

First question is on fire it up I'm wondering as you start to penetrate and really a lot of effort into the oncology portion on the lens business.

Sure.

It's a data point that you have that's alright, I can really help us begin to quantify.

All those efforts are progressing and then in fact I cant do you have a sense of what proportion of the patients are expected to stay away all the brand if I caught that.

Just trying to figure out if these additional generics come to the market and how much erosion. We're looking at for this fourth quarter.

Sure.

Operator: Thanks for the question, Sam. For the first one, I'll turn it over to Jeff. Jeff, you want to give us some updates?

Richard Daly: Thanks for the question, Sam. For the first one, I'll turn it over to Jeff. Jeff, you want to give us some updates?

Thanks for the questions Sam for the first one and I'll turn it over to Jeff, Jeff I want to give us some update hi, Sam good morning.

Jeffrey Del Carmen: Sure. Hi, Sam. Good morning. As far as the Cancer-Associated LEMS and providing maybe some anecdotes or leading indicators on how performance is going, we will do that in future quarters. What we're continuing to do is, like we mentioned on the earnings call, our first goal was really to get that testing in place, which we were successful. Secondly, the updates to the NCCN guidelines, which again, we were also very successful in doing that last July. Very pleased with that. Currently, what we're doing is we're educating and working on educating physicians and group practices and hopefully partnering with them to change their care pathways and then also have screening arrangements put in place. Moving forward, when we are successful with those discussions and those partnerships, we will share some of the leading indicators.

Or is that cancer associated labs, and providing maybe some anecdotes or leading indicators on how performance is going we will do that in future quarters.

What we're continuing to do is like that like we mentioned on the earnings call.

The first goal was really to get that testing in place, which we were successful secondly, the updates to the <unk> guidelines, which again we were also very successful in doing that last July so very pleased with that currently what we're doing is we're educating and working on educating physicians and group practices.

Hopefully.

Partnering with them to change their care pathways and also have screening arrangements put in place moving forward. When we are successful with those discussions and those partnerships, we will share some of the leading indicators.

Operator: To build on that as well, oncology is a highly structured and complex marketplace. Since the NCCN guidelines, which actually gives us the opportunity or license, if you will, to begin those discussions, we got that back at the end of July. We're really excited about the conversations we're having with the decision-makers in the oncology marketplace. It is a process. We are working through it, and we expect, as we've said in the past, that that will deliver results in 2026. Sam, I'm just going to move on to your next question, if that's okay.

Richard Daly: To build on that as well, oncology is a highly structured and complex marketplace. Since the NCCN guidelines, which actually gives us the opportunity or license, if you will, to begin those discussions, we got that back at the end of July. We're really excited about the conversations we're having with the decision-makers in the oncology marketplace. It is a process. We are working through it, and we expect, as we've said in the past, that that will deliver results in 2026. Sam, I'm just going to move on to your next question, if that's okay.

So to build on that as well.

Oncology is a highly structured and complex marketplace and so since the <unk> guidelines, which would actually gives us the opportunity or license. If you will begin those discussions we got that back at the end of July.

And where.

We're really excited about the conversations we're having with the decision makers in the oncology marketplace. It is a process we're working through it and we expect as we've said in the past that that will deliver results in 2026.

I'm just going to what's your next question if that's okay.

Samantha Semenkow: Yes.

Yeah, So Jeff.

Operator: Jeff, the FYCOMPA stickiness, any thoughts on that?

Richard Daly: Jeff, the FYCOMPA stickiness, any thoughts on that?

Copper stickiness or any thoughts on that sure. So as you see by the the revenue numbers that we've reported by copper.

Jeffrey Del Carmen: Sure. As you see by the revenue numbers that we've reported, FYCOMPA continues to perform very well. We do believe a lot of that is from brand loyalty and the stickiness. As additional generics enter the market later this year, we do expect additional erosion to revenue. However, we do also expect some patients to remain loyal to the brand. As far as a specific percentage, we haven't really provided guidance on that. We're very confident in our guidance that we did provide for FYCOMPA.

Continues to perform better.

And we do believe a lot of that is from brand loyalty and the stickiness.

As additional generics enter the market later this year.

We do expect additional erosion to revenue.

However, we do also expect some patients to remain loyal to the brand.

As far as a specific percentage, we haven't really provided guidance on that.

And we're very confident in our guidance that we did provide for a lifetime.

Samantha Semenkow: That's very helpful. Thanks for taking the questions.

That's very helpful. Thanks for taking the questions.

Operator: Thanks, Sam.

Richard Daly: Thanks, Sam.

Thanks Sam.

Operator: Thank you. Next question today is coming from Joon Lee from Truist Securities. Your line is now live.

Thank you next question today is coming from Julian from truly Securities. Your line is now live.

Joon Lee: Congrats on a strong quarter. Thanks for taking the questions. This is an awesome one for June, just a couple from us. Just on the FYCOMPA stickiness, why are patients choosing to stay on FYCOMPA longer? What are you hearing from them? Can you remind us how many generics are currently in the market and how many we could expect by year-end? Just on FIRDAPSE, are you actively seeing oncology practices following the updated NCCN guidelines, or would you say that's more of a 2026 story? Thank you.

Congrats on a strong quarter and thanks for taking the question isn't last month in June just a couple of Vermont.

Just on the high complex stickiness.

Why are these patients choosing to stay on for a longer you know what are you hearing from them.

Remind us how many generics are currently on the market and how many you can expect by year end.

And then just on furnaces are you ought to be seeing oncology practices. Following the updated <unk> guidelines or do you see that monarch pessimistic story. Thank you.

I'm sorry could you just repeat the second question I just lost you for a second.

Operator: Sorry, could you just repeat the second question? I just lost you for a second.

Richard Daly: Sorry, could you just repeat the second question? I just lost you for a second.

Joon Lee: Yeah. Just on FIRDAPSE, are you actively seeing oncology practices following the updated guidelines, or is that more of a 2026 story?

Yeah, just on for it ops or your occupancy oncology practices. Following the updated guideline or is that more than twice that.

Sorry.

Operator: Thank you. Jeff, on the stickiness, obviously, FYCOMPA is a one-of-one in the marketplace. We have one generic in there. Do you want to speak to the potential stickiness?

Richard Daly: Thank you. Jeff, on the stickiness, obviously, FYCOMPA is a one-of-one in the marketplace. We have one generic in there. Do you want to speak to the potential stickiness?

Thank you Jeff on the on the stickiness.

Obviously.

<unk> is a one of one in the marketplace and then we have one generic in there. So do you want to speak to the potential stickiness sure. So.

Jeffrey Del Carmen: Sure. When you take a look at the generic competition right now for FYCOMPA, there's one, and that's Teva. Teva's generic is at about a 17+% discount to FYCOMPA. It's a relatively good market for us when competing against Teva's product. The stickiness, a lot of patients are afraid to switch medications for antiseizure medications. What they don't want is something where a generic one month, and then it's different so that they have a breakthrough seizure. One of the things that they like to do is stay on the branded that they've been on for the last 10, 12+ years. That lends to the stickiness of the product. Also, we still have field personnel for FYCOMPA that are out there talking to many of the physicians that prescribe antiseizure medications and financial resources to help patients that are on FYCOMPA.

When you take a look at the generic.

Competition right now for five comp, there's one and Thats Teva.

That tethers generic is at about a 17 plus percent discount to fight Tampa So.

It's a relatively.

Good market for us.

When competing against others product.

Stickiness a lot of patients.

Or are afraid that the switch medications for anti.

Anti seizure medications, what they don't want is something where a generic.

One month and then defer.

Different.

So that they have a breakthrough seizures. So one of the things that they like to do is stay on the branded that they've been on for the last 12 plus years, so that that that lends to the stickiness of the product also we still have field personnel per Fi copper that are out there talking to many of the.

Jeffrey Del Carmen: Also, we still have field personnel for FYCOMPA that are out there talking to many of the physicians that prescribe antiseizure medications and financial resources to help patients that are on FYCOMPA. I think all those things contribute to the stickiness, and that's what we've seen in the revenue that we reported. Does that answer your question about FYCOMPA?

<unk> that prescribed anti seizure medications and financial resources.

To help patients that are on by Tampa. So I think all of those things contribute to the stickiness and that's what we've seen in the revenue that we reported.

Jeffrey Del Carmen: I think all those things contribute to the stickiness, and that's what we've seen in the revenue that we reported. Does that answer your question about FYCOMPA?

Does that answer your question about by counsel.

Joon Lee: Yes.

Yeah.

Jeffrey Del Carmen: Okay, great. As far as the NCCN guidelines and the adoption of those, it is more of a 2026 part of our 2026. That's when we'll see more of the adoption. It is significant in our discussions with these group practices in getting the care pathways changed and to adopt the NCCN guidelines. We're starting to see those discussions pay off. Again, our goal for 2025 and the remainder of this year is really to accelerate screening for these patients, which will turn into, hopefully, patients that will be diagnosed with small cell lung cancer, LEMS, next year and then also transition to FYCOMPA or to FIRDAPSE.

Okay, great and as far as the <unk> guidelines and the adoption of those we it is more of a 2026.

You know.

Part of our 2020, that's when we'll see more of the adoption.

But it is significant in our discussions with these group practices in getting the care pathways changed and to adopt the <unk> guidelines. So we're starting to see those.

Those discussions pay off.

But again our goal for 2025 and the remainder of this year is really to accelerate screening.

For these patients, which will turn into hopefully patients that will be diagnosed with small cell lung cancer labs next year, and then also transitioned to <unk>. Thanks, Jeff.

Operator: Thanks, Jeff.

Richard Daly: Thanks, Jeff.

Operator: Thank you. As a reminder, that's star one to be placed in the question queue. Our next question is coming from Leland Gershell from Oppenheimer. Your line is now live.

As a reminder, that star one to be placed in the question queue.

Our next question is coming from Leland <unk> from Oppenheimer. Your line is now live.

Keith Savon: Hey, guys. It's Rohan on for Leland. Congrats on another strong quarter. I wanted to ask on AGAMREE if you've seen any changes in the prescriber base. It's been talked about before how as people get more acquainted with longer-term data from AGAMREE and real-world data, more prescribers may be inclined to come on and give their patients AGAMREE. Have you seen any change in the breakdown there or new prescribers? More so on AGAMREE, just given the scope of what the differentiated story can do, are you exploring any other opportunities outside of Duchenne? Yeah, that's all from me.

Rohan Mathur: Hey, guys. It's Rohan on for Leland. Congrats on another strong quarter. I wanted to ask on AGAMREE if you've seen any changes in the prescriber base. It's been talked about before how as people get more acquainted with longer-term data from AGAMREE and real-world data, more prescribers may be inclined to come on and give their patients AGAMREE. Have you seen any change in the breakdown there or new prescribers? More so on AGAMREE, just given the scope of what the differentiated story can do, are you exploring any other opportunities outside of Duchenne? Yeah, that's all from me.

Hey, guys, it's thrown on for Leland Congrats on another strong quarter I wanted to ask on again, if you've seen any changes in the prescriber base.

It's been talked about before.

People will get more acquainted with longer term data from a gallery and.

Real World data.

More prescribers, maybe and client too.

<unk> and <unk>.

Give their patients again.

Have you seen any change in the breakdown there are.

New prescribers and.

<unk>.

Given the scope of what the.

Differentiated story can do are you exploring any other opportunities outside of Duchenne.

And yeah, that's all for me.

Operator: Rohan, thanks for the question. Jeff, do you want to handle first?

Richard Daly: Rohan, thanks for the question. Jeff, do you want to handle first?

Brian Thanks for the question, Jeff do you want <unk> sure. So for our Gam rate, we're extremely pleased with how the launch has gone thus far over the last year and a half plus and we have seen strong adoption and like I mentioned, the top 45 centers of excellence for Duchenne muscular dystrophy makeup.

Jeffrey Del Carmen: Sure. For AGAMREE, we're extremely pleased with how the launch has gone thus far over the last year and a half plus. We have seen strong adoption. Like I mentioned, the top 45 centers of excellence for Duchenne muscular dystrophy make up about 80% of the steroid prescriptions for boys living with DMD. Each of the top 45 have enrolled at least one patient on AGAMREE. That's strong adoption there. When you take a look at the top 100 centers of excellence, we have over 95% penetration in those centers of excellence. Again, broad adoption. Then also, we've talked about the adoption across both segments of prednisone as well as EMFLAZA. Very confident and pleased with that performance thus far. Also the 257 healthcare providers that have prescribed AGAMREE, at least one patient on AGAMREE. Again, strong adoption.

80% of the steroid prescriptions for boys living with DMD.

And each of the top 45 have enrolled at least one patient on a gamut. So thats strong adoption there.

When you take a look at the top 100 centers of excellence.

We have over 95% penetration in those market and those centers of excellence. So again broad adoption and then also we've talked about the adoption across all segments of prednisone as well as in Plaza, So very confident and pleased with that performance. Thus far and also the 257 health care providers that help.

Prescribed.

<unk> at least one patient on <unk>. So it gets strong adoption now what our focus is to continue to deepen that adoption.

Jeffrey Del Carmen: Now what our focus is to continue to deepen that adoption so that we can get more and more patients within each center on AGAMREE as these physicians see the differentiation of AGAMREE versus the other steroids. That's our goal moving forward.

So that we can get more and more patients within each center on a gallery as these physicians see the differentiation of <unk> versus the other steroids. So that's our goal moving forward.

Operator: On the second question regarding additional opportunities beyond Duchenne, first, we'll turn it over to Will Andrews, our Chief Medical Officer. Will?

Richard Daly: On the second question regarding additional opportunities beyond Duchenne, first, we'll turn it over to Will Andrews, our Chief Medical Officer. Will?

On the second question regarding additional opportunities beyond Duchenne first we'll turn it over to Wil Andrews, our Chief Medical Officer will.

Operator: Yes. Hello. Thank you, Rich. We are evaluating lifecycle management opportunities for consideration of add-on indications for AGAMREE. As an example, you can imagine, we look at disorders that have muscle inflammation that significantly affect function in patients and even other inflammatory disorders. We are actively evaluating lifecycle management opportunities.

Will Andrews: Yes. Hello. Thank you, Rich. We are evaluating lifecycle management opportunities for consideration of add-on indications for AGAMREE. As an example, you can imagine, we look at disorders that have muscle inflammation that significantly affect function in patients and even other inflammatory disorders. We are actively evaluating lifecycle management opportunities.

Yes, Hello, Thank you rich.

We are evaluating lifecycle management opportunities.

For consideration of add on indications for <unk> and as an example, you can imagine we look at disorders that have.

Muscle inflammation that significantly affect function in patients.

And even other inflammatory disorders. So we are actively evaluating lifecycle management opportunities.

Operator: Thanks, Will. I would just emphasize that our lifecycle opportunities are focused in the rare space. We want to continue with the profile that we have with the product. We're really excited about the things we're exploring right now, and we'll probably be addressing those on future calls.

Richard Daly: Thanks, Will. I would just emphasize that our lifecycle opportunities are focused in the rare space. We want to continue with the profile that we have with the product. We're really excited about the things we're exploring right now, and we'll probably be addressing those on future calls.

Thanks will and I would just emphasize that our like our lifecycle opportunities are focused in the rare space. So we want to continue with the profile that we have with the product. So we're really excited about the things we're exploring right now.

And.

We'll probably be addressing those in future on future calls.

Operator: Thank you.

Rohan Mathur: Thank you.

Thank you.

Operator: Thank you.

Richard Daly: Thank you.

Thank you.

Okay.

Operator: Thank you. Next question today is coming from Pavan Patel from Bank of America. Your line is now live.

Thank you. Your next question today is coming from Pavan Patel from Bank of America. Your line is now live.

Jeffrey Del Carmen: Hey, guys. Thanks for taking my questions. The first one is on AGAMREE. I believe you mentioned that you've reached nearly all of the DMD centers of excellence. Maybe if you can provide some more color on the depth of prescribing versus breadth, and what feedback are you getting from physicians and payers about the profile, and what do you see as the main hurdle to full conversion in this patient population? On FIRDAPSE, just the growth is pretty strong on a year-over-year basis, and you reaffirmed your full-year guidance for that product rather than raising it. That sort of implies a sequential slowdown. Just wondering if this reflects conservatism, or are you anticipating that true slowdown in Q4? Can you elaborate on which growth driver, whether it's new patients, enhanced dosing, or persistence, is contributing the most to your year-over-year growth? Thank you.

Pavan Patel: Hey, guys. Thanks for taking my questions. The first one is on AGAMREE. I believe you mentioned that you've reached nearly all of the DMD centers of excellence. Maybe if you can provide some more color on the depth of prescribing versus breadth, and what feedback are you getting from physicians and payers about the profile, and what do you see as the main hurdle to full conversion in this patient population? On FIRDAPSE, just the growth is pretty strong on a year-over-year basis, and you reaffirmed your full-year guidance for that product rather than raising it. That sort of implies a sequential slowdown. Just wondering if this reflects conservatism, or are you anticipating that true slowdown in Q4? Can you elaborate on which growth driver, whether it's new patients, enhanced dosing, or persistence, is contributing the most to your year-over-year growth? Thank you.

Hey, guys. Thanks for taking my questions. The first one is on again.

I believe you mentioned that you've reached nearly all of the DMD centers of excellence. So maybe if you can provide some more color on the depth of prescribing versus breadth and what feedback are you getting from physicians and payers about the profile and what you see as the main hurdle to full conversion.

In this patient population.

And then on <unk>, just the growth is pretty strong on a year over year basis.

And you and you reaffirmed your full year guidance for that product rather than raising it so.

That sort of implies a sequential.

Slowdown just wondering if this reflects conservatism or are you anticipating that to slow down in <unk> and <unk>.

Can you elaborate on which growth driver, whether it's new patients enhanced dosing or persistence is contributing the most year year over year growth. Thank you.

Operator: Thanks, Pavan. Oh, yes. FIRDAPSE here. I'm sorry. We were just clarifying your second question, and we'll come back to that. Jeff, do you want to handle the first one on centers of excellence in depth and breadth?

Richard Daly: Thanks, Pavan. Oh, yes. FIRDAPSE here. I'm sorry. We were just clarifying your second question, and we'll come back to that. Jeff, do you want to handle the first one on centers of excellence in depth and breadth?

Thanks Savannah.

But yes for that yet so I'm sorry, just like we were just clarifying your second question and we'll come back to that Jeff you want to handle the first one on centers of excellence in depth and breath sure. So very good question and it truly does vary across all of the centers of excellence, what's very unique about duchenne muscular dystrophy is one center.

Jeffrey Del Carmen: Very good question. It truly does vary across all the centers of excellence. What's very unique about Duchenne muscular dystrophy is one center of excellence is far different from the next one. There's not one uniform way that they prescribe steroids for their boys living with DMD. We have many of these centers with multiple patients on it, like 10, 20, and in some cases, many more than that, or much more than that. We have other centers that only have a handful of patients. That's what our goal is. We have to look at these as a unique center of excellence. One center, it means that you know one center of excellence. We have to identify a variety of ways to help provide education on the differentiation for AGAMREE for that center that's pertinent to them.

Excellent.

Is.

Far different from the next one so there's not one uniform way that they prescribe steroids or their boys living with DMD. So we have many of these centers with multiple patients on at like 10, 20 and in some cases, many more than that are much more than that and then we have other centers.

That only have a handful of patients. So that's what our goal is we have to look at these as a unique center of excellence one.

Center. It means that you know one center of excellence, so we have to identify.

A variety of ways to help provide education on the differentiation for a gambling for that center, that's pertinent to them. So hopefully that answers your question, but it varies across all 40 top 45 in the top 100.

Jeffrey Del Carmen: Hopefully, that answers your question, but it varies across all top 45 and the top 100. Then as far as the payers, when we look at the payer reception for AGAMREE, I mentioned it on the call, over 85% of the patients are reimbursed, and it's much more than that. It's a very strong reception by the payer, and the payer landscape we're very pleased with, and we don't anticipate it changing here in the growth.

And then as far as the payers when we look at the payer reception for for our Gam rate.

I mentioned it on the call over 85% of the patients are reimbursed.

It's much more than that so it's a very strong reception by the payer and the payer landscape. We're very pleased with and we don't anticipate it changing here.

Yes.

Operator: Pavan, your second question, we just want to clarify, was about the year-over-year strength, and then what are the growth drivers that we anticipate? You mentioned new patients, dosing. I think there was a third one you mentioned as well.

Richard Daly: Pavan, your second question, we just want to clarify, was about the year-over-year strength, and then what are the growth drivers that we anticipate? You mentioned new patients, dosing. I think there was a third one you mentioned as well.

Your second question, we just want to clarify it was about the year.

Year over year strength, and then what are the growth drivers that we anticipate is that could you mentioned new patient dosing I think there was one third one you mentioned on the last one was persistence.

Jeffrey Del Carmen: The last one was persistence of patients.

Pavan Patel: The last one was persistence of patients.

Operator: Persistence. Okay.

Richard Daly: Persistence. Okay.

<unk> persistent okay. Yeah, and then also on the sequential slowdown implied by the guidance. If you can explain that.

Jeffrey Del Carmen: Yeah. Also on the sequential slowdown implied by the guidance, if you can explain that.

Pavan Patel: Yeah. Also on the sequential slowdown implied by the guidance, if you can explain that.

Operator: Okay.

Richard Daly: Okay.

Okay.

Jeffrey Del Carmen: Just to make sure we're talking about FIRDAPSE, correct?

To make sure we work on the <unk> correct.

Operator: Right.

Pavan Patel: Right.

Jeffrey Del Carmen: Okay. Yeah. What I want to talk about here is I did mention this, that the growth from FIRDAPSE will come from multiple segments, both idiopathic LEMS as well as the Cancer-Associated LEMS. What we're seeing now is the 500 or so patients, the pool of patients that we have that are somewhere in their diagnostic journey for LEMS, we are able to help these patients or convert these patients onto treatment appropriately much more quickly. We're doing that by helping focus our dedicated field force of 16 RAMs now on the right leads to help these patients get on therapy quicker. That's one thing. Another thing is we have many initiatives in place to get VGCC antibody testing added to panels. An example is myasthenia gravis.

Alright, okay. So.

Yes.

What I want to talk about here is I.

I did mentioned this that the growth from <unk> will come from multiple segments, both idiopathic lens and as well as the cancer associated lamps, what we're seeing now is the.

500, or so patients that the pool of patients that we have that are somewhere in the diagnostic journey for labs, we are able to help these patients or convert these patients onto treatment appropriately much more quickly and we're doing that by helping focus our field force our dedicated field force of 16 ramps.

Now on the right leads to help these patients get on therapy.

That's one thing another thing is.

Our we have many initiatives in place to get BGC antibody testing added two panels.

An example is.

<unk> gravis, so once that's.

Jeffrey Del Carmen: Once that's added, we'll also see a growth in the number of patients that are tested and hopefully diagnosed with LEMS, which we can then focus on and help these patients get on therapy. Another thing is we've identified additional data sources that are providing more prospective LEMS patients to us, which will then turn into leads that increase our pool of patients. We also utilize machine learning that helps triangulate claims data. Here's a quick example: we've noticed that patients that have a negative AChR test as well as a positive VGCC test, those patients are more likely to get on FIRDAPSE treatment and get on treatment sooner. We provide those leads to our RAM team to help those patients accelerate their time to get on product. That's been very beneficial. A couple of other things, a pharmacy intervention program.

Added we'll also see a growth in the number of patients that are tested and hopefully diagnosed with lens, which we can then focus on and help these patients get on therapy.

Another thing is we've identified additional data sources that are providing more lens.

<unk> lens patients.

To us, which will then turn into leads that.

And increase our pool of patients.

We also utilize machine learning that helps to triangulate claims data. So here's a quick example is we've noticed that patients that have a negative AC HR test as well as a positive the GCC.

Those patients are more likely to get on <unk> treatment and get on treatment sooner. So then we provide those leads to our Ram team to help those patients accelerate their time to get on product. So that's been very beneficial couple of other things a pharmacy intervention program.

Jeffrey Del Carmen: A couple of other things, a pharmacy intervention program. What we're doing is we noticed that in some cases, it takes patients a little longer to titrate than the label to get onto their appropriate optimal dose. Our pharmacy outreach and the intervention program, we've seen benefits from that program that have accelerated that time to get on their appropriate optimal maintenance dose more efficiently. A lot of those things are helping contribute to today's growth, and we are confident we'll continue to provide levers for us to grow in the future. In 2026, we expect CA-LEMS to contribute more to the growth of FIRDAPSE.

Jeffrey Del Carmen: What we're doing is we noticed that in some cases, it takes patients a little longer to titrate than the label to get onto their appropriate optimal dose. Our pharmacy outreach and the intervention program, we've seen benefits from that program that have accelerated that time to get on their appropriate optimal maintenance dose more efficiently. A lot of those things are helping contribute to today's growth, and we are confident we'll continue to provide levers for us to grow in the future. In 2026, we expect CA-LEMS to contribute more to the growth of FIRDAPSE.

What we're doing is we noticed that in some cases it takes patience a little longer to titrate in the label to get onto their optimal appropriate optimal dose and our pharmacy outreach and the intervention program. We've seen benefits from that program that has accelerated that time to get on there.

Their appropriate optimal maintenance dose more efficiently. So a lot of those things are helping contribute to today's growth and we are confident we will continue to provide.

The levers for us to grow in the future and then in 2026, we expect CA lens to.

More or contribute more to the growth Alberta.

Is that does that address your question.

Operator: Pavan, does that address your question?

Richard Daly: Pavan, does that address your question?

Jeffrey Del Carmen: Yeah. That addresses the question pretty well. I guess just in terms of the guidance, why not take it up on FIRDAPSE at the product level given the strength thus far? Just what's the rationale behind that? Is that just conservatism, or is there something that you expect in Q4, whether there was a one-timer in Q3 or something like that?

Pavan Patel: Yeah. That addresses the question pretty well. I guess just in terms of the guidance, why not take it up on FIRDAPSE at the product level given the strength thus far? Just what's the rationale behind that? Is that just conservatism, or is there something that you expect in Q4, whether there was a one-timer in Q3 or something like that?

Yeah that addresses the question pretty well and then I guess just like in terms of like the guidance why not taken up on furnaces at the product level.

Given the strength, thus far just what's the rationale behind that is that just conservatism or is there something that you expect in.

In <unk>, whether there was a one timer in <unk> or something like that.

Operator: We know this product really, really well. For seven years, it's been on the market. We're confident in our ability to forecast the product. Jeff, do you want to speak at a high level to the performance of new enrollees in the Q3? Just at a high level.

Richard Daly: We know this product really, really well. For seven years, it's been on the market. We're confident in our ability to forecast the product. Jeff, do you want to speak at a high level to the performance of new enrollees in the Q3? Just at a high level.

So we know this product really really well for <unk>.

Seven years, it's been on the market. So we're confident in our ability to forecast the product of Jeff do you want to speak at a high level to the performance of <unk>.

New enrollees in the third quarter, just at a high level sure New enrollees were.

Jeffrey Del Carmen: Sure. New enrollees were actually very strong and much higher than we had forecasted. It was the highest month that we've had in two years.

There is strong and much higher than we had forecasted.

So it was the the highest month that we've had in two years, yeah. So so but those patients obviously, we don't get a full year for those patients. So we're looking forward to that growth continuing as we go into 2026. So we are seeing very positive trends, we like what we see we like what we see on the testing growth as well.

Operator: Yeah. Those patients, obviously, we don't get a full year from those patients. We're looking forward to that growth continuing as we go into 2026. We're seeing very positive trends. We like what we see. We like what we see on the testing growth as well. There's a touch of, I would say, a touch of seasonality in the Q4. We can look at sequentials, or we can look at year-over-year, but we're confident in our continued growth.

Richard Daly: Yeah. Those patients, obviously, we don't get a full year from those patients. We're looking forward to that growth continuing as we go into 2026. We're seeing very positive trends. We like what we see. We like what we see on the testing growth as well. There's a touch of, I would say, a touch of seasonality in the Q4. We can look at sequentials, or we can look at year-over-year, but we're confident in our continued growth.

<unk>.

It touches I wouldn't say a touch of seasonality in the fourth quarter. So.

We can look at sequential so we can look at a year over year, but we're confident in our continued growth.

Jeffrey Del Carmen: Great. Thank you so much. Super helpful.

Pavan Patel: Great. Thank you so much. Super helpful.

Great. Thank you so much super helpful. Thank you.

Operator: Thank you.

Richard Daly: Thank you.

Operator: Thank you. Next question today is coming from Luke Herrmann from Robert W. Baird. Your line is now live.

Thank you. Your next question today is coming from Lou Herman from Robert W. Baird. Your line is Bella.

Joon Lee: Hi, guys. Congrats on the quarter, and thanks for the question. First, on AGAMREE, given this week's outcome of confirmatory data from the approved PMOs, which is obviously just really unfortunate for the community, but do you think this can sort of emphasize the importance of an optimal steroid regimen for physicians and patients and their families?

Luke Herrmann: Hi, guys. Congrats on the quarter, and thanks for the question. First, on AGAMREE, given this week's outcome of confirmatory data from the approved PMOs, which is obviously just really unfortunate for the community, but do you think this can sort of emphasize the importance of an optimal steroid regimen for physicians and patients and their families?

Hi, guys congrats on the quarter and thanks for the question first on the January given this week's outcome of confirmatory data from the approved PMO.

Which is obviously just really unfortunate for the community, but do you think this can sort of emphasize the importance of an optimal steroid regimen for physicians and patients and their families.

Operator: That's a great question. This is a community that's very, very tight. They see everything, they're really engaged with us and obviously all the companies. When we think about the use of a product like AGAMREE, it's obviously the first product that a patient gets on. It's recommended. It's foundational therapy. These stories are unfortunate for the community. As we gain further and further strength and momentum in the market, we believe that we can fill the necessary gaps that might be coming out as a result of some of these conversations. Jeff, do you want to speak to what we might have heard so far about some of these issues surrounding the studies? Yeah.

Richard Daly: That's a great question. This is a community that's very, very tight. They see everything, they're really engaged with us and obviously all the companies. When we think about the use of a product like AGAMREE, it's obviously the first product that a patient gets on. It's recommended. It's foundational therapy. These stories are unfortunate for the community. As we gain further and further strength and momentum in the market, we believe that we can fill the necessary gaps that might be coming out as a result of some of these conversations. Jeff, do you want to speak to what we might have heard so far about some of these issues surrounding the studies? Yeah.

That's a great question.

This is a community that is very very tight.

They know they see everything in there they are really engaged with with that with us and obviously all the all the companies and.

When we think about the use of a product like a gallery.

Sure.

It's obviously the first product that a patient gets on recommended it's foundational therapy.

These news stories are unfortunate for the community, but as we gain further and further strength and momentum in the market. We believe that we can fill the necessary.

Sorry gaps that that might be coming out about as a result of some of these conversations Jeff do you want to speak to what we might've heard so far about some of these issues.

Surrounding.

The studies yeah sure.

Jeffrey Del Carmen: Sure. I mean, I'll stick to the AGAMREE and steroids. I mean, I think what Rich was mentioning too is that steroids are the foundation of treatment for boys living with DMD. We know that having that is the biggest part of this. Regardless of what other products that come out, the steroids will always be the first thing that they will treat their patients with, so.

I'll stick to the big again.

Gambling and steroids.

I think what rich was mentioning two is that they are.

Those are the foundation of treatment.

And so that we know that having that is the biggest part of this and regardless of what other products that come out.

The steroids will always be the first thing that they will treat their patients with so yeah, and I think our patient advocacy and patient support really helps us to kind of weather that those those bumps in the market that don't necessarily affect us directly.

Operator: Yeah. I think our patient advocacy and then patient support really helps us to kind of weather those bumps in the market that don't necessarily affect us directly. The support that we give to the patients through Catalyst Pathways is really a strong opportunity for the patients to get past some of these situations. We think we can continue to perform well.

Richard Daly: Yeah. I think our patient advocacy and then patient support really helps us to kind of weather those bumps in the market that don't necessarily affect us directly. The support that we give to the patients through Catalyst Pathways is really a strong opportunity for the patients to get past some of these situations. We think we can continue to perform well.

The support that we give to the patients through catalyst pathways is really a strong strong.

Opportunity for the patients to get past some of these situations.

<unk>.

We think we can continue to perform well.

Joon Lee: Great. I just had one on the financials and some commentary on payment timing in relation to the cash balance. I think you noted a lower gross-to-net expense. Is that material for gross-to-net going forward, and was that a benefit in Q3?

Luke Herrmann: Great. I just had one on the financials and some commentary on payment timing in relation to the cash balance. I think you noted a lower gross-to-net expense. Is that material for gross-to-net going forward, and was that a benefit in Q3?

Great and then I just had one on the financials.

And some commentary on payment timing in relation to the cash balance I think you noted a lower gross to net expense is that is that material for gross to net going forward and was that a benefit in <unk>.

Operator: Sure. Thanks for the question. It's not insignificant. From a materiality perspective, certainly, we thought it was noteworthy. Sorry, what was the second part of that question?

Richard Daly: Sure. Thanks for the question. It's not insignificant. From a materiality perspective, certainly, we thought it was noteworthy. Sorry, what was the second part of that question?

Sure. Thanks for the question.

It's not insignificant.

So from a reality perspective, certainly we thought it was noteworthy.

And then I'm sorry, what was the second part of that question.

It is.

Joon Lee: Is this an impact on a go-forward basis, or did it affect Q3 as well?

Luke Herrmann: Is this an impact on a go-forward basis, or did it affect Q3 as well?

Is this an impact on a go forward basis or did it affect you as well.

Operator: Yes. It is in Q3 and impacts the future as well. This is a permanent change to our contract terms.

Richard Daly: Yes. It is in Q3 and impacts the future as well. This is a permanent change to our contract terms.

Well.

Uh huh.

It is in Q3 and impacts in the future as well this is a permanent change to our.

Our contract terms.

Jeffrey Del Carmen: Right. I just want to emphasize that it's a permanent change. We experienced this one-timer mostly because of a if you think about a shift, we renegotiate a very, very important, very large contract with a buyer. They used to pay twice a month. Now they only pay once a month. We received their payment October.

Emphasize that it's a permanent change we experienced this onetime or mostly because you think about a shift we renegotiated a very very important very large contract with a buyer and they used to pay twice a month now they only pay once a month. So we received their payment October Tober second we received 20 approximately $24 $9 million set under the.

Operator: 2 October, we received approximately $24.9 million. That under the old terms would have been by 30 September.

Richard Daly: 2 October, we received approximately $24.9 million. That under the old terms would have been by 30 September.

Old terms would've been by September 30th So for this issue specifically because you are asking about it we don't expect this one to repeat yes. So this is a one timer and that's why we called it out in the Q. We wanted to be sure that we're clear about how it might affect Q3, but we expect that.

Jeffrey Del Carmen: For this issue specifically, because you're asking about it, we don't expect this one to repeat.

Operator: That's right.

Richard Daly: That's right.

Jeffrey Del Carmen: Yeah. This is a one-timer, and that's why we called it out in the Q. We wanted to be sure that we were clear about how it might affect Q3. We expect the customer to continue to pay once a month. We think that's accommodated for it will be accommodated for it on a go-forward basis.

The customer to continue to pay once a month and we think thats accommodated for it will be accommodated for on a go forward basis.

Operator: Yes. All right. Thank you.

Richard Daly: Yes. All right. Thank you.

Alright, thank you.

Jeffrey Del Carmen: Thanks.

Luke Herrmann: Thanks.

Operator: Thank you.

Jeffrey Del Carmen: Thank you.

Thank you.

Joon Lee: Thank you. Next question today is coming from Sudan Loganathan from Stephens Inc. Your line is now live.

Thank you. Your next question today is coming from Sudan Wilkinson from Stephens, Inc. Your line is now live.

Keith Savon: Hey. Good morning, Catalyst team. This is Keith Savon for Sudan. Congrats on the great quarter. My first question is just roughly with the 17% off the WAC when Teva came in, what's the expected discount on FYCOMPA after more tablet and suspension generics enter later this year, and how does that discount curve look? Then my second one is kind of just on FIRDAPSE. With Hetero moving to trials slated for March 2026, what was the general sentiment during the Markman hearing considering that Teva and Lupin kind of decided to settle? Thank you.

Hey, good morning catalyst team. This is Keith on for Stan Congrats.

Congrats on the great quarter.

My first question is just like you.

Roughly with the 17% of the whack when television came in what is the expected discount onsite copper after more tablet and suspension generics enter later this year and how does that discount curve look and then my second one is kind of just sunbird apps.

With hetero moving to trials slated for March 2026, what was the general sentiment during the markman hearing considering that TVN lupin kind of decided to settle thank you.

Operator: Thanks. On the first part of the first question, what we see is a mix shift, as you would expect. When a generic enters the market, especially one that's so heavily influenced here by Medicaid, we're not affected in the Medicaid on our volume basis. We have not given price, but as we forecasted, we would lose volume. There's a mixed shift. There's, as a percentage, a higher percentage of Medicaid, a lower percentage of commercial, that's what causes the price to go down. The volume changes, and it shifts, we have an impact on price. Does that answer your question?

Richard Daly: Thanks. On the first part of the first question, what we see is a mix shift, as you would expect. When a generic enters the market, especially one that's so heavily influenced here by Medicaid, we're not affected in the Medicaid on our volume basis. We have not given price, but as we forecasted, we would lose volume. There's a mixed shift. There's, as a percentage, a higher percentage of Medicaid, a lower percentage of commercial, that's what causes the price to go down. The volume changes, and it shifts, we have an impact on price. Does that answer your question?

Thanks, So on the first part of the first question. What we see is the mix shift as you would expect so and when a generic enters the market, especially one that's so heavily influenced here by Medicaid were not affected in the Medicaid on a volume basis. So we did not we have not given price, but as as we forecasted we would lose volume and then theres a mixed.

Shifting so there's as.

As a percentage a higher percentage of Medicaid a lower percentage of commercial and so that's what causes the price to go down so the volume changes and it shifts and then we have an impact on price so.

Does that answer your question.

Keith Savon: Yeah, it does. Thank you.

Yes. It does thank you okay.

Operator: Okay. Great. Now, your second question about Hetero and where we stand, I'm going to turn it over to Steve Miller. Steve?

Richard Daly: Okay. Great. Now, your second question about Hetero and where we stand, I'm going to turn it over to Steve Miller. Steve?

Now your second question about hetero, and where we stand I'm going to turn it over to Steve Miller, Steve. Thank you.

Stephen Miller: Thank you. With regard to the Markman hearing, it was relatively routine. There was a number of items that were simply pushed off to trial. The judge said simply, That's a matter for trial. There were no outcomes that dramatically changed the view of the enforceability of the patents for either side and the strength of their cases. We continue to remain confident that our intellectual property is strong, and we're going to vigorously defend it. I also want to point out that, like all the litigants of the past, we continue to have discussions with all of them, including Hetero. If this last litigant has something to say that we think is in the best interest of the shareholders, we'll act on it.

Steven Miller: Thank you. With regard to the Markman hearing, it was relatively routine. There was a number of items that were simply pushed off to trial. The judge said simply, That's a matter for trial. There were no outcomes that dramatically changed the view of the enforceability of the patents for either side and the strength of their cases. We continue to remain confident that our intellectual property is strong, and we're going to vigorously defend it. I also want to point out that, like all the litigants of the past, we continue to have discussions with all of them, including Hetero. If this last litigant has something to say that we think is in the best interest of the shareholders, we'll act on it.

Sure.

Martin here.

Relative.

There was.

A number of items that were simply.

Pushed off too.

Said simply that's a matter for trial.

There was no.

Dramatic change the view.

Horses.

Sorry.

The strength of the cases we.

To remain confident.

Actual property is strong and we're going to vigorously defend them I also want to point out that like all the litigants through the past two years.

Have discussions with all of them.

If this last litigant have something to say that we think this is the best interest of the shelf.

Sure.

Joon Lee: Thank you.

Keith Savon: Thank you.

Thank you.

Jeffrey Del Carmen: Thank you.

Richard Daly: Thank you.

Thank you.

Joon Lee: Thank you. We reached the end of our question-and-answer session. I could turn the floor back over for any further or closing comments.

Operator: Thank you. We reached the end of our question-and-answer session. I could turn the floor back over for any further or closing comments.

Thank you we reached end of our question and answer session I like to turn the floor back over for any further or closing comments.

Jeffrey Del Carmen: We're really appreciative of the support that we've received from the market, and we're really appreciative of the work that our employees have done in support of patients. Thank you again for your participation in the call today.

Richard Daly: We're really appreciative of the support that we've received from the market, and we're really appreciative of the work that our employees have done in support of patients. Thank you again for your participation in the call today.

We're really appreciative of the support that we've received from the market and we're really appreciative of the work that our employees have done in support of patients and thank you again for your participation on the call today.

Joon Lee: Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.

Operator: Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.

Thank you that does conclude today's teleconference and webcast you may disconnect. Your lines at this time and have a wonderful day, we thank you for.

For your participation today.

Q3 2025 Catalyst Pharmaceuticals Inc Earnings Call

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