Q4 2024 Catalyst Pharmaceuticals Inc Earnings Call

Operator: Greetings and welcome to the Catalyst Pharmaceuticals fourth quarter in full year 2024 financial At this time, all participants are on a listen-only mode. A question-and-answer session will follow the formal... If anyone should require operator assistance, please press star zero on your telephone.

Greetings and welcome to the catalyst pharmaceuticals fourth quarter and full year 'twenty 'twenty four financial results conference call. At this time, all participants are in a listen only mode.

A question and answer session will follow the formal presentation. If anyone should require operator assistance. Please press star zero on your telephone keypad.

Operator: As a reminder, this conference is being recorded.

As a reminder, this conference is being recorded it is now my pleasure to introduce your host Mike out.

Michael: It is now my pleasure to introduce Michael Good morning, everyone. And thank you for joining our conference call to discuss Catalyst's fourth quarter and full year 2024 financial results and business highlights.

You may begin.

Speaker Change: Good morning, everyone and thank you for joining our conference call to discuss catalysts fourth quarter and full year 'twenty 'twenty four financial results and business highlights.

Unknown Executive: Leading the call today is Richard Daly, Catalyst's President and Chief Executive Officer. We're also joined by Jeff Del Carmen, our Chief Commercial Officer. Further, for the Q&A session, Dr. Steven Miller, our Chief Operating Officer and Chief Scientific Officer, and Dr. Gary Ingenito, our Chief Medical and Regulatory Officer, will be available for questions.

Speaker Change: Leading the call today is Richard Daley catalysts, President and Chief Executive Officer.

Speaker Change: We're also joined by Jeff del Carmen, Our Chief Commercial officer further for the Q&A session. Dr. Steven Miller, our Chief operating Officer, and Chief Scientific Officer, and Dr. Gary Ingenito, our chief Medical and regulatory officer will be available for questions.

Unknown Executive: 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 law. These statements relate to our current expectations, estimates, and projections, and are not guarantees of future performance. They involve risks, uncertainties, and assumptions that are difficult to predict and may prove not to be accurate. Actual results may vary from the expectations contained in our forward-looking statement.

Speaker Change: 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.

Speaker Change: Future results, which may be forward looking statements for purposes of federal Securities laws.

Speaker Change: These statements relate to our current expectations estimates and projections and are not guarantees of future performance.

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

Speaker Change: 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.

Unknown Executive: 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.

Richard Daly: At this time, I'll turn the call over to Rick. Thanks, Mike. Good morning, everyone, and thank you for joining us today.

Speaker Change: Kay.

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

Rich: Thanks, Mike Good morning, everyone and thank you for joining us today.

Richard Daly: 2024 was an exceptional year marked by record revenue growth and a strong fourth quarter that showcased our scalability and financial strength reinforcing the success of our strategy. For the full year 2024, total revenues grew by 23.5% year over year to $491.7 million, exceeding the upper end of our previous guidance and highlighting our ability to capitalize on market opportunities while maintaining operational excellence. Full year net product revenue for 2024 reached $489.3 million, an exceptional 23.4% increase over 2023. fueled in part by our continued successful launch of Agamery, which began on March 13th, 2024. In Q4 2024, total revenues and net product revenues reached a record $141.8 million, an increase of 28.3% and 30% over Q4 2023 respectively.

Rich: 'twenty 'twenty four was an exceptional year marked by record revenue growth and a strong fourth quarter that showcased our scalability and financial strength reinforcing the success of our strategy.

Rich: For the full year 2024, total revenues grew by 23, 5% year over year to $491 $7 million exceeding the upper end of our previous guidance and highlighting our ability to capitalize on market opportunities, while maintaining operational excellence.

Rich: Full year net product revenue for 2024 reached $489 $3 million.

Rich: An exceptional 23, 4% increase over 2023.

Rich: Fueled in part by our continued successful launch of a gallery, which began on March 13th 2024.

Rich: In Q4 2020 for total revenues and net product revenues reached a record $141.8 million, an increase of 28, 3% and 30% over Q4 2023, respectively.

Richard Daly: The increase was driven by the continued organic growth of Firdaps, steady contributions of Ficompa, and new revenue from Agamri, which accounted for a portion of the year-over-year increase.

Rich: The increase was driven by the continued organic growth of deferred apps steady contributions of five copper and new revenue from our Gambari, which accounted for a portion of the year over year increase.

Richard Daly: Looking ahead, we expect this momentum to continue with 2025 total revenue forecasted to be between $545 million and $565 million.

Rich: Looking ahead, we expect this momentum to continue with 2025 total revenue forecasted to be between $545 million and $565 million.

Richard Daly: We ended the year with a robust cash position of $517.6 million and no debt, providing an enhanced capacity to invest in strategic growth opportunities. Catalyst's competitive advantage is built on the commitment of our outstanding team and the strength of our patient engagement services, such as Catalyst Pathways. Additionally, our strong relationship with healthcare and rare disease communities drives meaningful stakeholder engagement. Together, our holistic approach enables the patients we serve to streamline access. Identify appropriate therapy, receive timely treatment, and remain compliant with their care. Firdaf's sustained momentum reflects the strength of this approach, delivering 14 consecutive quarters of 15% or more growth year over year.

Rich: We ended the year with a robust cash position of $517 $6 million and no debt, providing enhanced capacity to invest in strategic growth opportunities.

Rich: Catalysts competitive advantage adult on the commitment of our outstanding team and the strength of our patient engagement services such as catalyst pathways. Additionally.

Additionally, our strong relationship.

Rich: And chip with health care and rare disease communities drives meaningful stakeholder engagement.

Rich: Together, our holistic approach enables the patients we serve to streamline access.

Rich: Identify appropriate therapy received timely treatment and remain compliant with their care.

Rich: <unk> sustained momentum reflects the strength of this approach delivering 14 consecutive quarters at 15% or more growth year over year.

Richard Daly: As the only evidence-based treatment for LEMS in the U.S., we believe that Firdapse is well positioned to maintain this trajectory for the foreseeable future. Given the incredible benefits Firdaps offers to patients and the opportunity for continued growth, we remain committed to building this therapy.

Rich: As the only evidence based treatment for labs in the U S. We believe that ferd apps is well positioned to maintain this trajectory for the foreseeable future.

Rich: Given the incredible benefits for <unk> offers to patients and the opportunity for continued growth we remain committed to building this therapy.

Richard Daly: Jeff will discuss this in greater detail later in the call. In January 2025, we secured a favorable resolution to the Teva patent litigation, prohibiting Teva's generic entry until February 2035, absent other occurrences and reinforcing Firdap's intellectual property strength. The litigation between the remaining two generic first filers is ongoing, and we remain fully committed to doing everything we can to protect the long-term value of our franchise.

Rich: Jeff will discuss this in greater detail later in the call.

Speaker Change: In January 2025, we secured a favorable resolution to the Teva patent litigation.

Speaker Change: Prohibiting Teva generic entry until February 2035, absent other occurrences and reinforcing ferd apps as intellectual property strength.

Speaker Change: The litigation between the remaining two generic first filers is ongoing and.

Speaker Change: And we remain fully committed to doing everything we can to protect the long term value of our franchise.

Richard Daly: Turning to a gamma ray. Since its launch in March 2024, GAMI has gained significant traction, securing share from both branded and generic sides of the market. This is a true testament to the market's recognition of Agamri's potential differentiation. We've had great success and broad acceptance in many DMV centers of excellence, and we now turn our efforts to going deeper into the COEs to help more patients experience the potential benefits of this unique steroid. As the GAMRI enters its second year, we expect the adoption momentum to evolve to a sustained growth trajectory, reinforcing confidence in the long-term growth potential.

Speaker Change: Turning to a gamut.

Speaker Change: Since its launch in March 2024, Gam has gained significant traction securing share from both branded and generic sides of the market.

Speaker Change: This is a true testament to the market's recognition of the gamba is potential differentiation.

Speaker Change: We've had great success in broad acceptance in many DMD centers of excellence and we now turn our efforts to going deeper into the coes to help more patients experienced the potential benefits of this unique steroid.

Speaker Change: As a gallery enters its second year, we expect the adoption momentum to evolve to a sustained growth trajectory reinforcing confidence in our long term growth potential.

Richard Daly: Summit Study is up and running, enrolling patients. This is a key long-term initiative to provide insight into a GAMRI's unique therapeutic profile and strengthen its market position. This five-year open-label study aims to provide real-world data versus historic control. on the potential long-term benefits of a gamma, including improvements in behavior, stature, bone health, and cardiovascular health. We look forward to working with the Participating Centers on Enrollment and Future Data Analysis. Tricompa has established strong patient preference due to its proven efficacy and benefits in seizure control. We are proactively implementing targeted strategies to manage FICOMPA's lifecycle ahead of its expected patent expiry in May of 2025.

Speaker Change: The summit study is up and running enrolling patients.

Speaker Change: This is a key long term initiatives to provide insight into our galleries unique therapeutic profile and strengthen its market position.

Speaker Change: This five year open label study aims to provide real world data versus historic controls.

Speaker Change: Oh on the potential long term benefits of the gamma including improvements in behavior.

Speaker Change: Stature bone health and cardiovascular health.

Speaker Change: We look forward to working with the participating centers on enrollment and future data analyses.

Speaker Change: Copper has established strong patient preference due to its proven efficacy and benefits in seizure control.

Speaker Change: We are proactively implementing targeted strategies to manage by Cabos lifecycle ahead of its expected patent expiry in may of 2025.

Richard Daly: We anticipate a gradual revenue decline in the second half of 2025 as physicians and patients prioritize clinical stability, with a continued decline in 2026 and beyond as payer-driven transitions accelerate.

Speaker Change: We anticipate a gradual revenue decline in the second half of 2025 as physicians and patients prioritize clinical stability with a continued decline in 2020 six and beyond as payer driven transitions accelerate.

Richard Daly: Jeff will provide an overview of our commercial performance, followed by Mike's financial update later in the call. As we execute our strategic priorities, our buy and build approach remains a core pillar of our long term growth, driven by disciplined business development. We are actively evaluating several accretive and near-accretive rare disease opportunities, prioritizing strong clinical differentiation and a clear commercialization potential. While we have not yet found the right opportunity, we continue to make significant progress on this front, leveraging our rigorous due diligence process in an effort to secure the right assets at the right time to drive sustainable success.

Speaker Change: Jeff will provide an overview of our commercial performance followed by Mike's financial update later in the call.

Speaker Change: As we execute our strategic priorities, our buy and build approach remains a core pillar of our long term growth driven by disciplined business development.

Speaker Change: We are actively evaluating several accretive and near accretive rare disease opportunities prioritizing strong clinical differentiation and a clear commercialization potential.

Speaker Change: While we have not yet found the right opportunity we continue to make significant progress on this front leveraging a rigorous due diligence process in an effort to secure the right assets at the right time to drive sustainable success.

Richard Daly: Our international strategy has two core elements. First, we are building a sustainable network of outlicensing partners with whom we can rapidly transact in the future, a plug and play strategy. Second, As with our approach in the US, we seek markets where our products can make a difference. ones in which our products would represent a differentiated offering. Enhance access to care and improve health equity.

Speaker Change: Our international strategy has two core elements first we are building a sustainable network of out licensing partners with whom we can rapidly transact in the future.

Speaker Change: Our plug and play strategy.

Speaker Change: Second.

Speaker Change: As with our approach in the U S. We seek markets, where our products can make a difference ones in which our products would represent a differentiated offering.

Speaker Change: The enhanced access to care and improve health equity.

Richard Daly: In January 2025, our sub-licensee, Daito Pharma, successfully launched Firdeps in Japan, expanding access for LEMS patients in this key market. Meanwhile, CHI Pharmaceuticals, our licensee in Canada, remains on track to submit a new drug submission for GAMRI to Health Canada early 2025. As part of our strategic focus, we remain vigilant in navigating market and regulatory challenges. including Evolving Healthcare Policies and a Shifting Competitive Landscape. By staying agile and adapting to industry changes, we are well positioned to manage risks and drive growth. Leveraging our rare disease expertise and operational excellence, we believe that we are well positioned to drive sustained growth and capitalize on emerging opportunities for long-term value.

Speaker Change: In January 2025 are Sublicensee Dido pharma successfully launched <unk> in Japan, expanding access for <unk> patients in this key market.

Speaker Change: Meanwhile, Kai pharmaceuticals, our licensee in Canada remains on track to submit our new drug submission for Gary to Health, Canada early 2025.

Speaker Change: As part of our strategic focus we remain vigilant and navigating market and regulatory challenges.

Speaker Change: Including evolving health care policies, and a shifting competitive landscape.

Speaker Change: By staying agile and adapting to industry changes, we are well positioned to manage risks and drive growth.

Speaker Change: Leveraging our rare disease expertise and operational excellence, we believe that we are well positioned to drive sustained growth and capitalize on emerging opportunities for long term value.

Jeff Del Carmen: Now I'd like to turn the call over to Jeff Del Carmen, our Chief Commercial Officer. Jeff. Thanks, Rich, and good morning, everyone. We are thrilled with our exceptional performance in 2024, marked by full-year net product revenue of $489.3 million and total revenues of $491.7 million, surpassing the upper end of our 2024 full-year total revenue guidance of $475 to $485 million. This outstanding achievement was driven by Firdap's full-year revenue, reaching a record high of $306 million, the successful U.S. commercial launch of Agamery, and the continued strong contribution from FICOM.

Speaker Change: Now I'd like to turn the call over to Jeff del Carmen, Our Chief Commercial Officer, Jeff.

Speaker Change: Thanks, Rich and good morning, everyone. We are thrilled with our exceptional performance in 2024 marked by full year net product revenue of $489 3 million in total revenues up $491 7 million, surpassing the upper end of our 2024 full.

Speaker Change: All year total revenue guidance of $475 million to $485 million.

Speaker Change: This outstanding achievement was driven by <unk> with full year revenue, reaching a record high of 306 billion. The successful U S commercial launch of a gambling.

Speaker Change: And the continued strong contribution from Phi compound.

Jeff Del Carmen: Let's start by reviewing our advancements with Firdapse, the only evidence-based FDA-approved treatment for Lambert-Eaton myasthenic syndrome. In the fourth quarter, net product revenue amounted to $82.5 million, showcasing a remarkable 18.3% year-over-year growth. Furthermore, Firdaft's net product revenue for 2024 showed strong 18% growth year over year, driven by a steady influx of new patient initiations and a low annual discontinuation rate of under 15%, exceeding internal expectations. Prescription approval rates exceeded 90% for all types of payers, including government and private commercial insurers. Patients enrolled in Catalyst Pathways, including those with Medicare coverage, accessing third-party foundation assistance. experienced an average monthly copay of less than $2.

Speaker Change: Let's start by reviewing our advancements with <unk>. The only evidence based FDA approved treatment for Lambert Eaton Myasthenic syndrome in the fourth quarter net product revenue amounted to $82 5 million showcasing a remarkable 18, 3% year over year growth.

Speaker Change: Furthermore, bird apps as net product revenue for 2024 showed strong 18% growth year over year, driven by a steady influx of new patient initiations.

Speaker Change: And a low annual discontinuation rate of under 15% exceeding internal expectations.

Speaker Change: Prescription approval rates exceeded 90% for all types of payers, including government and private commercial insurers patients enrolled in catalyst pathways, including those with Medicare coverage accessing third Party Foundation assistance.

Speaker Change: <unk> and average monthly co pay of less than $2.

Jeff Del Carmen: Now I'd like to turn to a game. We are proud of Agamri's successful commercial launch and its growing recognition as a breakthrough treatment for Duchenne muscular dystrophy. full year 2024 net product revenue reached 46 million surpassing the revised guidance of 40 million to 45 million. In Q4 2024, Agamri delivered strong net sales of $21.1 million, driven by increasing adoption. Adoption has been robust, with 93% of the top 45 DMD Centers of Excellence and 209 unique healthcare providers submitting enrollments for IGAMI. We continue to see strong transitions from both corticosteroid segments, with 44% coming from prednisone and 43% coming from enfloss.

Speaker Change: Now I'd like to turn to a game right. We are proud of our Gam really successful commercial launch and its growing recognition as a breakthrough treatment for duchenne muscular dystrophy.

Speaker Change: Full year 2024, net product revenue reached 46 million, surpassing the revised guidance of 40 million to 45 million.

Speaker Change: In Q4, 2024, our Gam read delivered strong net sales of $21 1 million driven by increasing adoption.

Speaker Change: Adoption has been robust with 93% of the top 45 D. M. D centers of excellence and 209 unique health care providers submitting enrollments for again right.

Speaker Change: We continue to see strong transitions from both corticosteroids segments with 44% coming from prednisone, and 43% coming from N Plaza.

Jeff Del Carmen: Additionally, 85% of shipments were reimbursed with an average approval time of approximately nine business days after we received a completed enrollment. We anticipate further reductions in approval time as payers finalize their policies in the coming month.

Speaker Change: Additionally, 85% of shipments were reimbursed with an average approval time of approximately nine business days. After we received they completed enrollment for them.

Speaker Change: We anticipate further reductions in approval time as payers finalized or policies in the coming months.

Jeff Del Carmen: Lastly, I would like to provide a brief overview of FICOMPA. For the fourth quarter of 2024, FICOMPA delivered strong results supported by steady demand that reinforced its market position. Q4 2024 net product revenue of $38.2 million. further strengthened our revenue diversification. FICOMPA's full year 2024 net product revenue reached $137.3 million, surpassing our guidance range of $130 million to $135 million.

Speaker Change: Lastly, I would like to provide a brief overview of <unk> for the fourth quarter of 2024, five comp have delivered strong results supported by steady demand that reinforced its market position.

Speaker Change: Q4, 2024, net product revenue of $38 2 million.

Speaker Change: Further strengthened our revenue diversification.

Speaker Change: By campus full year 2024, net product revenue reached $137 3 million, surpassing our guidance range of $130 million to $135 million.

Jeff Del Carmen: To enhance our focus on the markets for Firdapse and Engamery, we have made a strategic decision to divide our commercial field-based team into two dedicated units. The Firdeps Field Force will consist of 16 regional account managers. while the InGAMRI Field Force will include 12 regional accountants. We anticipate implementing this focused approach by early Q2 with most of the additional headcount filled by internal personnel.

Speaker Change: To enhance our focus on the market's preferred outstanding Camry, we have made a strategic decision to divide our commercial field based team into two dedicated units.

Speaker Change: The <unk> field force will consist of 16 regional account managers.

Speaker Change: While the <unk> field Force will include 12 regional account managers.

Speaker Change: We anticipate implementing this focused approach by early Q2 with most of the additional head count filled by internal personnel.

Jeff Del Carmen: We are confident that Firdapse's organic growth in 2025 will exceed 15%, driven by several key factors. The continued conversion of a portion of the 500-plus identified lens patients to Firdeft's treatment will be a significant contributor. Additionally, the approval of the expanded 100 milligram label in June 2024 enables patients to access a higher daily dose when appropriate, further supporting growth. Furthermore, we are well positioned to capitalize on the Cancer Associated LEMS opportunity by shifting our focus. toward community-based oncology physicians. who we estimate treat approximately 85% of all cancer patients. We expect that this strategic pivot will allow us to more effectively target the approximately 90% of small cell lung cancer LEMS patients who remain undiagnosed.

Speaker Change: We are confident that ferd apps as organic growth in 2025 will exceed 15% driven by several key factors.

Speaker Change: The continued conversion of a portion of the 500 plus identified lens patients to <unk> treatment will be a significant contributor.

Speaker Change: Additionally, the approval of the expanded 100 milligram label in June 2024 enables patients to access a higher daily dose when appropriate further support supporting growth.

Speaker Change: Furthermore, we are well positioned to capitalize on the cancer associated lens opportunity by shifting our focus toward community based oncology physicians, who we estimate treat approximately 85% of all cancer patients.

Speaker Change: We expect that this strategic pivot will allow us to more effectively target the approximately 90% of small cell lung cancer patients who remain on diagnosed our efforts will center on implementing B G. C. C antibody screening programs with major G. P OS.

Jeff Del Carmen: Our efforts will center on implementing BGCC antibody screening programs with major GPOs, accelerating LEMS diagnosis.

Speaker Change: Accelerating lens diagnosis rates.

Jeff Del Carmen: In 2025, the dedicated field force will create deeper adoption of Agamri in the approximately 100 DMD COEs, allowing for continued growth following the initial surge of early adoption. The crowded DMD landscape has created a competition for share of voice within these institutions. In addition, we believe there is a cuing effect for patients as they are evaluated for treatment of new therapies, delaying initiation of a Gamma-ray for some patients. However, we remain confident that our dedicated Agamery field force will continue to expand Agamery's adoption across both prednisone and emphysema sectors.

Speaker Change: In 2025, the dedicated field force will create deeper adoption of a gambari EMEA approximately 100 D. M D C O, allowing.

Speaker Change: Allowing for continued growth following the initial surge of early adopters the.

Speaker Change: The crowded DMD landscape has created a competition for share of voice within these institutions. In addition, we believe there was a killing effect for patients is they are evaluated for treatment of new therapies delaying initiation of a gamley for some patients.

Speaker Change: However, we remain confident that our dedicated a gambling field force will continue to expand and gamergate adoption across both prednisone and employs a segments.

Jeff Del Carmen: Finally, as we mentioned, FICOMPA loses exclusivity in May 2022. We will continue to leverage personal promotion through LOE due to the promotional sensitivity with anti-seizure medication.

Speaker Change: Finally, as we mentioned by comp loses exclusivity in May 2025, we will continue to leverage personal promotion through low.

Speaker Change: Due to the promotional sensitivity with anti seizure medications.

Jeff Del Carmen: In summary, our exceptional performance in 2024 reflects the strength of our product portfolio and our ability to meet the needs of diverse patient populations. Strategic Investments in Marketing, Education, and Patient Support have been pivotal to this success, and we are committed to building on this momentum. We look forward to driving sustained commercial execution and making a meaningful impact on the patient communities we serve.

Speaker Change: In summary, our exceptional performance in 2024 reflects the strength of our product portfolio and our ability to meet the needs of diverse patient populations strategic investments in marketing education and patient support had been pivotal to the success. We are committed to building on.

Speaker Change: This momentum.

Speaker Change: We look forward to driving sustained commercial execution, and making a meaningful impact on the patient communities we serve IX.

Jeff Del Carmen: I express sincere appreciation to the entire Catalyst team for their unwavering dedication to patients. I eagerly look forward to a prosperous year ahead.

Speaker Change: I express sincere appreciation to the entire catalyst team for their unwavering dedication to patient I eagerly look forward to a prosperous year ahead.

Michael: I will now turn the call back over to Mike.

Mike Out: I will now turn the call back over to Mike.

Michael: Thank you, Jeff. As Rich and Jeff mentioned, Catalyst's fourth quarter and full year 2024 financial performance resulted in another record breaking year, driven by exceptional execution by all facets of our business. In addition to our outstanding I'd like to highlight the incredible work done by the Catalyst team with the commercial launch of Agamri in March of 2024.

Mike Out: Thank you Jeff.

Speaker Change: As rich and Jeff mentioned catalysts fourth quarter and full year 2024 financial performance resulted in another record breaking year, driven by exceptional execution by all facets of our business and.

Speaker Change: In addition to our outstanding results I would like to highlight the incredible work done by the catalyst team with the commercial launch of a gallery in March of 2024.

Michael: Now on to 2024 results. Our total revenues for 2024 were $491.7 million, a 23.5% increase when compared to total revenues of $398.2 million for 2023. Product revenue net for 2024 from our lead product, Firdaps, was $306 million, an 18.4% increase year over year, compared to $258.4 million for 2023. Product revenue net for GAMRI was $46 million for the period from the commercial launch on March 13, 2024 through year end. Product revenue net for FICOMPO was $137.3 million compared to $138.1 million for 2023. As mentioned previously, 2024 FICOMPA net product revenue was adversely affected by growth to net changes compared to 2023 when our growth to net for FICOMPA was booked under a size more favorable arrangements with distributors and government agencies.

Speaker Change: Now on to 'twenty 'twenty four results.

Speaker Change: Our total revenues for 2024 were $491 7 million, a 23, 5% increase when compared to total revenues of $398 $2 million for 2023.

Speaker Change: Product revenue net for 2024 from our lead product first ups was $306 million and 18, 4% increase year over year compared to $258 $4 million for 2023.

Speaker Change: Product revenue net for Gary was $46 million for the period from the commercial launch on March 13th 2024 through year end.

Speaker Change: Product revenue for <unk> was $137 $3 million compared to $138 $1 million for 2023.

Speaker Change: As mentioned previously 2024 or five comp in net product revenue was adversely affected by gross to net changes compared to 2023, when our gross to net for <unk> was booked under a size more favorable arrangements with distributors and government agencies.

Michael: Starting in 2024, all such costs have been tied to arrangements between us and those distributors and government agencies. Since our costs under these arrangements are higher than the size costs, we were impacted by an increase in gross to net deductions for phycompa therapy, causing a corresponding decrease in phycompa net product revenue. During 2024, we recognized approximately $2.4 million in license and other revenue, which consisted primarily of a $2.1 million milestone payment earned upon Dido receiving product approval to commercialize Firdapse for the treatment of patients with LEMS in Japan. 2023 license and other revenue was approximately $1.7 million, which included a $1.4 million milestone earned as a result of DADO submitting a Japan NDA for Fert Apps to the Pharmaceutical and Medical Devices Agency in Japan.

Speaker Change: Starting in 2024, all such costs have been tied to arrangements between us and those distributors and government agencies.

Speaker Change: Since our cost under these arrangements are higher than the science costs, we were impacted by an increase in gross to net deductions for Fi combo therapy, causing a corresponding decrease in <unk> net product revenue.

Speaker Change: During 2024, we recognized approximately $2 $4 million in license and other revenue, which consisted primarily of a $2 1 million dollar milestone payment earned upon Dino receiving product approval to commercialize <unk> for the treatment of patients with <unk> in Japan.

Speaker Change: 2023 license and other revenue was approximately $1 7 million, which included a $1 $4 million milestone earned as a result of data submitting the Japan NDA preferred apps to the pharmaceutical and medical devices agency in Japan.

Michael: For 2025, we are forecasting Firdap's net product revenue to be between $355 million and $360 million, which also reflects an increase in the U.S. gross net driven by the Inflation Reduction Act, or IRA, impact on our Medicare Part D Firdap sale. We expect that the IRA impact will continue to increase annually. We are forecasting a GAMRI 2025 net product revenue to be between $100 and $110 million and we are forecasting FICOMPA 2025 net product revenue to be between $90 and $95 million. In 2025, FICOMPA net product revenue will be impacted by the loss of exclusivity and the anticipated generic entrance into the FICOMPA market.

Speaker Change: For 2025, we are forecasting <unk> net product revenue to be between $355 million and $360 million, which also reflects an increase in the U S. Gross to net driven by the inflation reduction act or IRA <unk>.

Speaker Change: Impact on our Medicare part D for it ourselves.

Speaker Change: We expect that the IRA impact will continue to increase annually.

Speaker Change: We are forecasting a gamba 2025, and net product revenue to be between 101 hundred $10 million and we're forecasting five comp of 2025 net product revenue.

Speaker Change: To be between 90 and $95 million in.

Speaker Change: In 2025 by Comping net product revenue will be impacted by the loss of exclusivity in the anticipated generic entrants into the copper market.

Michael: Finally, based on Dido's commercialization of Firdapps in Japan, we expect to record some revenue, which is included in the Firdapps guidance, based on the sale of Firdapps to Dido in lieu of receiving royalties. While we do not expect our 2025 revenue from sales to Dido to be material, we believe that our global expansion to make our product available to LEMS patients and other jurisdictions to be an important element of our business plan.

Speaker Change: Finally based on <unk> commercialization of <unk> in Japan, we expect to record some revenue which is included in the <unk> guidance based on the sale of Fedex to Dino and Lou of receiving royalties.

Speaker Change: While we do not expect our 2025 revenue from sales to data to be immaterial, we believe that our global expansion to make our product available to <unk> patients in other jurisdictions to be an important element of our business plan.

Michael: We reported U.S. GAAP net income for 2024 of $163.9 million, or $1.38 per basic and $1.31 per diluted share, an increase of 130% year-over-year compared to GAAP net income for 2023 of $71.4 million. or 67 cents per basic and 63 cents per diluted share. The increase in net income year over year is attributable to growth in Firdap's net product revenue and the addition of net product revenue resulting from the launch of the GAMR. Additionally, in 2023, we recorded the one-time McGamery-related $81.5 million acquisition-related IP R&D experience. Non-GAAP net income for 2024 was $276.3 million, or $2.33 per basic and $2.21 per diluted share.

Speaker Change: We reported U S. GAAP net income for 2024 of $163 $9 million or $1.38 per basic and $1.31 per diluted share an increase of 130% year over year compared to GAAP net income for 2023.

Speaker Change: Of $71 $4 million or <unk> 67 per basic and <unk> 63 per diluted share.

Speaker Change: The increase in net income year over year is attributable to growth in <unk> net product revenue and the addition of net product revenue, resulting from the launch of the gallery.

Speaker Change: Additionally, in 2023, we recorded the onetime or Gam related $81 5 million dollar acquisition related IP R&D expense.

Speaker Change: non-GAAP net income for 2024 was $276 $3 million or $2 33 per basic and $2 21.

Speaker Change: Our diluted share.

Michael: which excludes the income tax provision of $52.4 million, amortization of intangible assets related to our acquisitions of Resurgi, Ficomp, and Agamri of $37.4 million. Stock Base Compensation Expense of $22.3 million and Depreciation of $397,000 from Gap Net Income. This compares to non-GAAP net income for 2023 of $141.6 million, or $1.33 per basic and $1.25 per diluted share, which excludes the income tax provision of $23.1 million. amortization of intangible assets of $32.6 million. Stock-based compensation expense of $14.3 million. and depreciation of $316,000 from Gap Net Income. These non-GAAP results represent an approximate 95% increase of non-GAAP net income year-over-year.

Speaker Change: Which excludes the income tax provision of $52 4 million amortization of intangible assets related to our acquisitions of reserves <unk> comp in a gallery of $37 $4 million.

Speaker Change: Stock based compensation expense of $22 3 million.

Speaker Change: And depreciation of $397000 from GAAP net income.

Speaker Change: This compares to non-GAAP net income for 2023 of $141 6 million or $1 33 per basic and $1.20 per diluted share, which excludes the income tax provision of $23 $1 million.

Speaker Change: Amortization of intangible assets of $32 $6 million stock.

Speaker Change: Stock based compensation expense of $14 $3 million.

Speaker Change: And depreciation of $316000 from GAAP net income.

Speaker Change: These non-GAAP results, representing approximately 95% increase of non-GAAP net income year over year.

Michael: As a reminder, in Q3 2023, we acquired Agamri commercial rights in advance of U.S. FDA approval, which required that the company expense the acquired IP R&D at the time of the acquisition. Our cost of sales in 2024 was approximately $68.8 million compared to $52 million in 2023 and consisted principally of royalties. GAMRI royalties paid to the product license are increased based on different net sales criteria. For 2025, we expect the GAMRI royalties to increase as a percentage of net sales compared to 2024 based on our net product revenue guidance of $100 to $110 million. The company is also required to make a $12.5 million milestone payment to our product licensor once the GAMRI's net product revenue in a calendar year reaches $100 million.

Speaker Change: As a reminder, in Q3 2023, we acquired <unk> commercial rights in advance of U S. FDA approval, which requires that the company expense the acquired IP R&D at the time of the acquisition.

Speaker Change: Our cost of sales in 2024 was approximately $68 $8 million compared to $52 million in 2023 and consisted principally of royalties.

Speaker Change: Gambari royalties paid to the product licenses or increase based on different net sales criteria.

Speaker Change: For 2025, we expect the <unk> royalties to increase as a percentage of net sales compared to 2024 based on our net product revenue guidance of $100 million to $110 million.

Speaker Change: The company is also required to make a $12 $5 million milestone payment to our product license or once the gamut as net product revenue in a calendar year reaches $100 million.

Michael: Further, we are required to pay royalties based on net product revenue to the product licensor for FICOMP, following the loss of exclusivity, which will occur in May 2025 for the tablets and in November 2025 for the oral suspension. The royalty rates are higher if there is no generic entry following loss of patent exclusivity than they are once generics enter the market. Research and development expenses were $12.6 million in 2024 compared to $93.2 million in 2023. As previously mentioned, the driver behind the decrease in research and development expenses relates to a one-time-a-gammery IP R&D expense of approximately $81.5 million during the third quarter of 2023.

Speaker Change: Further we are required to pay royalties based on net product revenue to the product license store for five comp.

Speaker Change: Knowing the loss of exclusivity, which will occur in May 2025 for the tablets and in November 2025 for the oral suspension.

The royalty rates are higher if there is no generic entry following loss of patent exclusivity than they are once generics enter the market.

Speaker Change: Okay.

Speaker Change: Research and development expenses were $12 $6 million in 2024 compared to $93 2 million in 2023.

Speaker Change: As previously mentioned the driver behind the decrease in research and development expenses related to a onetime a gallery IP R&D expense of approximately $81 $5 million during the third quarter of 2023.

Michael: Relative to the normal course of business, absent another acquisition, we are forecasting research and development costs in 2025 to be between $15 million and $20 million. We anticipate that our R&D expenses in future years may become more significant if we seek to execute on the development of additional indications for Firdapse and Agamery or if we acquire additional products still in development. SG&A expenses for 2024 totaled $177.7 million. compared to $133.7 million in 2023. The increase in SG&A year over year is principally due to expenses related to a GAMRI, including commercial support expenses, selling and marketing expenses, and an increase in corporate head count required to support the expanding company infrastructure.

Speaker Change: Relative to the normal course of business absent. Another acquisition, we are forecasting research and development costs in 2025 to be between $15 million and $20 million.

Speaker Change: We anticipate that our R&D expenses in future years may become more significant if we seek to execute on the development of additional indications for <unk> or if we acquire additional products still in development.

Speaker Change: SG&A expenses for 2024 totaled $177 7 million.

Speaker Change: Compared to $133 $7 million in 2023.

Speaker Change: The increase in SG&A year over year is principally due to expenses related to again reign, including commercial support expenses, selling and marketing expenses and an increase in corporate head count required to support the expanding company infrastructure.

Michael: We anticipate 2025 SG&A expenses to increase compared to 2024, primarily driven by increased headcount, including full-year costs for individuals hired throughout 2024 in certain functional areas to support the growth of our business and our overall strategy as we focus on expanding our product portfolio, and the launch of separate commercial and medical field forces for Firdapse and Agamery, which are scheduled to commence at the beginning of the second quarter. Our effective tax rate for 2024 was 24.2%, compared to 24.4% for 2023. 2024, the difference to the statutory federal income tax rate of 21% was primarily driven by state income taxes and anticipated annual permanent difference.

Speaker Change: We anticipate 2025 SG&A expenses to increase compared to 2024.

Speaker Change: Primarily driven by increased head count, including full year cost for individuals hired throughout 2024 and certain functional areas to support the growth of our business and our overall strategy as we focus on expanding our product portfolio.

Speaker Change: And the launch of separate commercial and medical field forces preferred apps in a gallery, which is scheduled to commence at the beginning of the second quarter.

Speaker Change: Our effective tax rate for 2024 was 24, 2% compared to 24, 4% for 2023.

Speaker Change: 2024, the difference to the statutory federal income tax rate of 21% was primarily driven by state income taxes and anticipated annual permanent differences.

Michael: We anticipate that our effective tax rate for 2025 will be relatively consistent with our 2024 and 2023 tax rates. It is important to note that our tax rate is affected by many factors, including the number of stock options exercised. State tax rates impacting our business and other items in any given period and is likely to fluctuate in future periods. I would like to emphasize that this is an annualized effective tax rate, which is not directly correlated to quarterly net income before income taxes, and may be higher or lower on a quarter-to-quarter basis, depending on how the company is trending against annualized net income before income taxes.

Speaker Change: Anticipate that our effective tax rate for 2025 will be relatively consistent with our 2024 and 2023 tax rates.

Speaker Change: It is important to note that our tax rate is affected by many factors, including the number of stock options exercised.

Speaker Change: The tax rates impacting our business and other items in any given period and is likely to fluctuate in future periods.

Speaker Change: I would like to emphasize that this is an annualized effective tax rate, which does not directly correlated to quarterly net income before income taxes and may be higher or lower on a quarter to quarter basis, depending on how the company is trending against annualized net income before income taxes.

Speaker Change: Yeah.

Michael: As we reported, we ended 2024 with cash and cash equivalents of $517.6 million compared to $137.6 million at December 31, 2023. The increase in cash of approximately $380 million was largely driven by approximately $240 million in cash provided by operating activities, as well as approximately $141 million raised in the January 2024 capital raise. We believe that our current funds continue to allow us the financial flexibility to fund our existing R&D activities. meet our potential contractual obligations. and support our strategic initiatives, business development and portfolio expansion efforts leading to long-term growth and value creation.

Speaker Change: As we reported we ended 2024 with cash and cash equivalents of $517 $6 million.

Speaker Change: <unk> to $137 $6 million at December 31, 2023.

Speaker Change: The increase in cash of approximately $380 million was largely driven by approximately $240 million in cash provided by operating activities as well as approximately $141 million raised in the January 2024 capital raise.

Speaker Change: We believe that our current funds continue to allow us the financial flexibility to fund our existing R&D activities.

Speaker Change: Our potential contractual obligations.

Speaker Change: And support our strategic initiatives business development and portfolio expansion efforts, leading to long term growth and value creation.

Michael: More detailed information and analysis of our full year 2024 financial performance may be found in our annual report on Form 10-K, which was filed with the Securities and Exchange Commission yesterday, February 26, 2025, and can be found on the Investor Relations page of our website at www.catalystpharma.com.

Speaker Change: More detailed information and analysis of our full year 2024 financial performance may be found in our annual report on Form 10-K, which was filed with the Securities and Exchange Commission Yesterday February 26, 2025, and can be found on the Investor Relations page of our website at <unk>.

Speaker Change: Ww dot catalyst pharma dot com.

Richard Daly: And with that, I will turn the call back over to Rick. As we embark on 2025, we are energized by the opportunities ahead and remain focused on delivering meaningful advancements for patients with rare diseases. Our passion, expertise, and unwavering commitment will continue to drive us forward as we execute our strategic priorities and expand our impact.

Rich: And with that I will turn the call back over to rich.

Mike Out: As we embark on 2025, we are energized by the opportunities ahead and remain focused on delivering meaningful advances for patients with rare diseases, our passion expertise and unwavering commitment.

Mike Out: We will continue to drive us forward as we execute our strategic priorities and expand our impact.

Richard Daly: I want to extend my gratitude to our employees, partners, and stakeholders for their dedication and support. Your contributions are instrumental in our success, and I look forward to what we will accomplish together in the year ahead.

Mike Out: To extend my gratitude to our employees partners and stakeholders for their dedication and support <unk>.

Mike Out: Contributions are instrumental in our success and I look forward to what we will accomplish together in your head.

Operator: I'd like to turn the call back to the operator. Thank you.

Mike Out: To turn the call back to the operator, thank you.

Mike Out: Okay.

Speaker Change: Thank you we will now be conducting a question and answer session if.

Operator: We will now be conducting a question... If you would like to ask a question, please press star 1 on your telephone. A confirmation tone will indicate your line is in the question.

Speaker Change: If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two to remove yourself from the queue co participants using speaker equipment. It may be necessary to pick up your handset before pressing the star.

Operator: You may press start to remove. Participants Using Speaker Equipment.

Charles Duncan: It may be necessary to pick up the handset before pressing the start One moment, please, while we pose for Our first question comes from the line of Charles Duncan with Canterfield Journal. Please proceed with your Thank you. Morning, Rich and team. Congrats on a great year of progress and thanks for taking our question. I had a question about Firdaps and really the guidance. I'm wondering if Jeff can provide a little bit more color on the new patient ads as well as the low discontinuation rate that you're seeing. And then with regard to guidance for Firdaps, it's fairly narrow, 355 to 360 versus, for example, a Gamery, which is broader.

Speaker Change: One moment, please while we poll for questions.

Speaker Change: Okay.

Speaker Change: Okay.

Charles Duncan: Our first question comes from the line of Charles Duncan with Cantor Fitzgerald.

Speaker Change: Please proceed with your question.

Speaker Change: Thank you good morning, rich and team congrats on a great year.

Speaker Change: And thanks for taking our question I had a question about <unk> and really the guidance.

Speaker Change: I'm wondering if Jeff can provide a little bit more color on the new patient adds.

Speaker Change: As well as the low discontinuation rate that Youre seeing and then with regard to guidance for <unk>, it's fairly narrow narrow $3 55 to $3 60 versus for example, a gallery, which is brighter.

Charles Duncan: And I'm kind of wondering why you have so much precision on the guidance at this stage with regard to Firdaps.

Speaker Change: I'm kind of wondering why you have so much precision on the guidance at this at this stage with regard to <unk>.

Jeff Del Carmen: Thanks for the question. Obviously, you know, we have a lot more experience with, with BirdApps.

Speaker Change: Thanks for the question.

Speaker Change: Obviously you know.

Speaker Change: We have a lot more experience with with bird apps, and I think Jeff I'll turn the call over to Jeff, but the pool of patients that we have and the continued confidence that we have in the in the brand and the uptake I think Jeff can speak to that more.

Jeff Del Carmen: And I think Jeff, I'll turn the call over to Jeff, but the pool of patients that we have and the continued confidence that we have in the brand and the uptake, I think Jeff can speak to that more, more clearly than I can. So Jeff, thanks, Rich. And good morning, Charles. As we've mentioned, we have over the 500 plus pipeline leads, and those are those patients that are diagnosed with LEMS, but not yet on FertABS. Those patients typically contribute about 50% to our new enrollments each month or any given quarter. So we have a good handle on that, what we have in front of us, and when we can help those patients transition on to therapy.

Jeff: Clearly the ICANN, so Jeff Thanks, Rich and good morning Charles.

Jeff: As we've mentioned we have over 500 plus pipeline Lee and those are those patients that are diagnosed with lens.

Speaker Change: But not yet on <unk> those patients typically contribute about 50% to our new enrollments each month or any given quarter. So we have a good handle on that but what we have in front of us and how when we can help those patients transition onto therapy, so that gives us confidence in.

Jeff Del Carmen: So that gives us confidence in that sense. Also, the discontinuation rate has been very steady since we launched this back in 2019. And actually, in 2024 full year, the annual discontinuation rate was 15%. So that was very strong. So we're very confident about that. And as Rich mentioned, our experience with this product and what we've seen, it's what you see typically with rare disease products in this sense is that you have a, for a while you get a steady state of enrollments. You know how many enrollments you're going to get every given month. So that allows us and gives us confidence as to how we project or forecast.

Jeff: That.

Jeff: Also the discontinuation rate has been very steady since we launched this back in 2019 and actually in 2020 for full year. The annual discontinuation rate was 15%. So that was very strong. So we're very confident about that and as rich mentioned our.

Jeff: Experience with this product and what we've seen is it's what you see typically with rare disease products in this sense.

Jeff: Is that you have a.

Jeff: For a while you get a steady state of enrollments you know what how many enrollments youre going to get every given month. So that allows us and gives us confidence as to how we project our forecast 2025.

Charles Duncan: Is that helpful, Charles? Yeah, it is helpful.

Charles Duncan: Helpful. Charles.

Charles Duncan: Yes. It is a helpful and I had just one follow up and this is more of a strategy question with regard to the deployment of cash Youre building cash nicely in the last year, and I guess I'm thinking about like comp.

Charles Duncan: And I had just one follow-up. And this is more of a strategy question with regard to the deployment of cash. You're building cash nicely in the last year. And I guess I'm thinking about FICOMPA and perhaps revenue being reduced in 26. Is it your plan to try to replace that revenue with another effort in epilepsy? Or are you not so concerned about epilepsy specifically and investing further in that? But what would you like to do in terms of the FICOMPA revs in 26? So, from a business development standpoint, we remain open to orphan and differentiated products that we think can make a difference for patients.

Charles Duncan: And perhaps revenue being reduced in 'twenty six.

Charles Duncan: Our plan too.

Charles Duncan: Tried to replace that revenue with not there.

Charles Duncan: In epilepsy or are you not so concerned about absolute Hep C, specifically and investing further in that but what would you like to do in terms of the bi compound Reds in 20 states.

Charles Duncan: So from a business development standpoint, we remain open to orphan and differentiated products that we think can make a difference for patients.

Jeff Del Carmen: If it's epilepsy, we stand behind the Phi Kappa acquisition as something that helped us build our war chest, if you will. But we want to stay in the orphan space. Retail is not a place we want to spend a lot more time in the future. If it's epilepsy and it's orphan, we would be interested in that. But we have a very wide aperture for acquisitions or partnerships for products. It's helpful.

Charles Duncan: It's epilepsy, we would.

Charles Duncan: We stand behind that the <unk> acquisition is something that helped us build our war chest. If you will but we want to we want to stay in the orphan space retail is not a place we want to spend a lot more time in the future.

Charles Duncan: If it's epilepsy and its orphan we would be interested in that but we spend we have a very wide aperture for acquisitions or partnerships for our products.

Jeff Del Carmen: Thank you.

Charles Duncan: That's helpful. Thank you.

Speaker Change: Thank you. Our next question comes from the line of Jason <unk> with Bank of America. Please proceed with your question.

Jason Gerberry: Our next Gerberry with Bank of America.

Jason Gerberry: Please proceed with your Hey guys, this is Bhavan on for Jason congrats on First question, I wanted to ask you guys what the new indication that you're pursuing with the GammaRay is, which we noted on the PR, and then the second question may be on M&A, is the company looking at gene therapy, which has proven challenging for others in biopharma, and just wanted to get your thoughts. efforts towards revenue diversification. Thank you. Well, thanks for the question. Regarding the new indications. So in the 10k, we did speak to some of the work that we're doing to further classify how we might go forward with, with a GAMRI.

Jason: Hey, guys. This is bothering on for Jason Congrats on the quarter.

Jason: First question I wanted to ask you guys, what the new indication that you are pursuing with <unk>.

Jason: Which you can read on the PR and then the second question maybe on M&A.

Jason: Is the company looking at gene therapy, which has to be challenging for others in biopharma.

Jason: And just wanted to get your thoughts on continued efforts towards revenue diversification. Thank you.

Jason: Well thanks for the question regarding the new indications. So in the 10-K, we did speak to some of the work that we're doing to further classify how we might go forward with.

Gary Ingenito: I'll turn that over to Gary, our Chief Medical Officer.

Jason: With Ah, Gary I'll turn that over to Gary.

Gary Ingenito: Gary, do you want to address the the work that we're doing there? Sure. Yes, you know, of course, our focus has been on the successful launch of Agamery, and we continue to look at rare diseases which can benefit from a unique corticosteroid in that. And in terms of that, we're further characterizing Agamery in terms of its ability to provide immunosuppression and look at the characteristics of the product. That will allow us to better assess it for all the potential possibilities in the rare disease. And to your question about gene therapy, obviously, when we look at the opportunity within the orphan space, we see the vast majority of orphan conditions have a gene component.

Speaker Change: Our Chief Medical Officer, Gary do you want to address the <unk>.

Jason: That we're doing there.

Gary: Sure. Thank you.

Gary: Yes, you know of course, our focus has been on the successful launch of a gambling and we continue to look at rare diseases, which can benefit from a unique critical steroid in that and in terms of that we're further characterizing our gam re in terms.

Gary: Its ability to provide immuno suppression and look at the characteristics of the product that will allow us to better assess it for all the potential possibilities in the rare disease space.

Gary: And to your question about gene therapy, obviously.

Gary: When we look at the opportunity within the orphan space, we see the vast majority of orphan conditions have a gene component. So this is something we track very very closely.

Gary Ingenito: So this is something we track very, very closely. We think about it in very similar ways that we think about our other opportunities on non gene therapy opportunities. However, we look at it with a little bit maybe a little bit more closely in a couple of components. Obviously, the opportunity has to be close to market, has to be immediately accretive or nearly immediately accretive. The CMC has to be very, very clean because we think this is incredibly challenging. I think you all know I come from a cell therapy background, obviously different from Gene, but closely aligned on the CMC component.

Gary: We think about it in very similar ways that we think about our other opportunity on non gene therapy opportunities. However, we look at it with a little bit.

Gary: Maybe a little bit more closely at a couple of components. Obviously the opportunity has to be close to market has to be immediately accretive or nearly immediately accretive.

Gary: The CMC has to be very very clean because we think this is incredibly challenging I think you all know I come from a cell therapy background, obviously different from gene, but closely aligned on the CMC component. So we will look at that we really want to be sure that we truly understand the CMC component of it and there has to be a clear need.

Gary Ingenito: So we look at that and we really want to be sure that we truly understand the CMC component of it. And there has to be a clear need. We've seen the uptake of gene therapy products be incredibly challenged. So we really want to understand the differentiated nature of the product for the therapy. And we want to understand what's going on in the market space. So we would consider it. However, we want to be really careful in understanding how the product might perform given the performance of past gene therapy products. Is that helpful?

Gary: We've seen the uptake of gene therapy products be incredibly challenged so we really want to understand the differentiation differentiated nature of the product for the therapy and we want to understand what's going on in the market space. So we would consider it however, we want to be really careful in understanding how the product might perform given the.

Gary: Performance of past gene therapy products.

Is that helpful.

Unknown Executive: Yep, that was great. Thank you guys. I really appreciate the help. Sure.

Speaker Change: Yes that was great. Thank you guys I really appreciate the help.

Gary: Sure.

Unknown Executive: Thank you.

Gary: Thank you.

Austin Ronald: Our next question comes from... Thank you. Congrats on the quarter and thanks for taking the questions. This is Austin Ronald on for Joon Lee. Just a question on the gross net. So you mentioned a gross net change for Firdaus in 2025. How much of a change should we expect from 24? And then what proportion of Firdaus patients are currently on the 100 milligram dose? Thank you. Thanks.

Speaker Change: Our next question comes from the line of John Lee withdrew its securities. Please proceed with your question.

Ronald: Congrats on the quarter and thanks for taking the questions. This is an awesome Ronald <unk> on for Joon Lee I.

Ronald: Just a question on the gross to net so you mentioned the gross net change refer to us in 2025.

Ronald: How much of a change should we expect from 24 and then what proportion of <unk> patients are currently on the 100 milligram dose.

Ronald: Sure.

Michael: First question, we'll turn over to Mike. And then the second question, we'll turn over to Jeff. Mike, do you want to take that one? Sure. Thanks. 2024, we saw a very small impact from the IRA, less than 1%. If you look at the gross net, we're thinking that based on the book of business, that could be in the three to three and a half percent range for 2025. And we'll continue to increase. As a reminder, we're under the small manufacturer. So there's a phased in approach over the coming years.

Rich: Thanks first question I will turn over to Mike and then the second question I will turn it over to Jeff Mike you want to take that one sure. Thanks rich.

Ronald: 24, we saw a very small impact from the IRA.

Less than 1% if you look at the gross connect were thinking that based on the book of business that could be in the three to three 5% range for 2025, and we will continue to increase as a reminder, we are under the small manufacturers. So theres a phased in approach.

Ronald: Three years.

Ronald: For the coming years, yes.

Jeff Del Carmen: And I'll answer the question about the dosing. What I can give you right now is our average daily dose has increased. We saw since the label expansion in June, the average daily dose increased about two milligrams. And we have forecasted for 2025, because of the increased availability or flexibility to physicians to optimize treatment for these patients, an additional two milligrams built into the forecast for. At this time, also, there are about 20% of our patients that are at about 100 milligrams. Thank you. Thank you.

Ronald: And I'll answer the question about the dosing what I can give you right now is our average daily dose has increased we saw since the label expansion in June.

Ronald: The average daily dose increased not two milligrams and we have forecasted for 2025 because of the increased availability of flexibility to physicians to optimize treatment for these patients.

An additional two milligrams built into.

Ronald: The forecast for us.

Ronald: At this time also there are about 20% of our patients that are at about 100 milligrams.

Ronald: Thank you.

Ronald: Thanks.

Ronald: Thank you.

Benjamin Palut: Our next question comes from the line of... Welcome to Seversons Northern California. Welcome to Seversons Southern California. Thank you for your patience. Hello, this is Benjamin Palut, Jonathan Sam. Thanks for taking our questions. Maybe starting with a GAMRI, can you speak to the factors that you expect to drive demand forward in 2025? And that support your 2025 guidance of 100 to 110 million? How should we think about the cadence of the launch throughout the year? Thanks Benjamin. I'll turn it over to Jeff for the demand question. Thanks for the question. And regarding a GAMRI, we mentioned the percent mix of the transition.

Ronald: Our next question comes from the line of Samantha.

Speaker Change: <unk> with Citi. Please proceed with your question.

Benjamin: Hello. This is Benjamin <unk>, John for Sam Thanks for taking our questions.

Speaker Change: Starting with <unk> can you speak to the factors that you expect to drive demand board in 2025 and that support your 2025 guidance of $100 million to $110 million, how should we think about the cadence of the launch throughout the year.

Speaker Change: Thanks, Benjamin I'll turn it over to Jeff for the.

Speaker Change: The demand question.

Speaker Change: Thanks for the question and regarding of Gambro, We mentioned the the percent mix of the transition so the boys living with DMD.

Jeff Del Carmen: So the boys living with DMD, 44% coming from the prednisone segment, and about 43% coming from emphysema. And that gives us extreme confidence in the continued growth, because we're seeing transitions across both sectors. Initially, when we launched, we expected more of our transitions to come from NPLASA for a variety of reasons. So having that gives, again, gives us confidence. We continue to expect transitions from both segments moving forward at a steady pace. I did mention the competitive landscape that we're seeing. So what we expect is over time, over this year, we'll see some of that effect of the queuing effect that I mentioned will be playing itself through.

Speaker Change: 44% coming from the prednisone segment, and about 43% coming from and Plaza.

Speaker Change: And that gives us <unk>.

Speaker Change: Extreme confidence in the continued growth because we're seeing transitions across both segments.

Speaker Change: Initially when we launched we expected more of our transitions to come from and Plaza for a variety of reasons. So having that gives again gives us confidence we continue to expect transitions from both segments moving forward at a steady pace I did mentioned the.

Speaker Change: Competitive landscape that we're seeing.

Speaker Change: So what we expect is over time over this year, we will see some of that effect.

Speaker Change: The killing effect that I mentioned will be playing itself through so probably in the middle of the year and we'll start seeing more acceleration in enrollments, which is built into the forecast that we provided does that help at all.

Jeff Del Carmen: So probably in the middle of the year, and we'll start seeing more acceleration in enrollments, which is built into the forecast that we provided. Does that help at all? Yeah, that's helpful. Thank you so much.

Speaker Change: Yeah. That's helpful. Thank you so much and then maybe moving over and referred apps can you speak to your expectations for revenue contribution from small cell lung cancer patients over 2025, how.

Jeff Del Carmen: And then maybe moving over to FertABS, can you speak to your expectations for revenue contribution from small cell lung cancer patients over 2025? How much growth are you expecting from this segment over the next several quarters? Yeah, Jeff will take that one as well. At this time, we see about 20% of our revenue or our patients are from the small cell lung cancer lens or cancer-associated lens segment. And we expect in 2025 to really focus on initiating or getting screening programs implemented. So it's really about helping those 90% of undiagnosed small cell lung cancer lens patients get diagnosed.

Speaker Change: How much growth are you expecting from this segment over the next several quarters.

Speaker Change: Yeah.

Jeff: Yeah, Jeff I'll take that one as well at this time, we see about 20% of our revenue or our patients.

Jeff: Our from the small cell lung cancer landstar cancer associated loans.

Jeff: Segment, and we expect in 'twenty five to really focus on initiating our getting screening programs implemented. So it's really about helping those 90% of undiagnosed small cell lung cancer Lance patients get diagnosed so that's where our focus so as far as contributions this year of growth.

Jeff Del Carmen: So that's where our focus. So as far as contributions this year or growth from the small cell lung cancer lens segment, it's going to be very minimal in 2025, but we expect that to grow and out. Yes, I'll just add to that. We've had a really thoughtful approach here in developing the KOL community around this in academic institutions. Jeff and the team have done a really, really good job of making sure we work closely with the KOLs to get the opportunity for understanding of how this would work, and now pivoting that effort now to the community where, as Jeff said, the vast majority of small cell lung cancer is treated.

Jeff: From the small cell lung cancer lengths.

Speaker Change: <unk> is going to be very minimal in 2025, but we expect that to grow in out years, yes, I'll just add to that.

Jeff: Done.

Jeff: Really thoughtful approach here in developing the KOL community around this and academic institutions, Jeff and the team have done a really really good job, making sure. We were work we work closely with the Kols to get the the opportunity for understanding of how this would work and now pivoting that effort now to the community where as Jeff said the majority of the vast majority.

Jeff: 30 of small cell lung cancer is treated.

Richard Daly: The KOLs are in position. I think our messaging is in position, and so we could pivot now and begin to work with those physicians in the community. So we're really excited about this opportunity.

Jeff: Wells are in a position I think our messaging is in position and so we can pivot now and begin to work with those physicians in the community. So we're really excited about this opportunity.

Unknown Executive: Great, thank you so much. Thanks.

Speaker Change: Great. Thank you so much.

Jeff: Thanks.

Jeff: Yes.

Unknown Executive: Thank you. Our next question comes from the line. Unknown Speaker 0 with. Please proceed. Great. Hey, everybody, thanks for taking my questions. Maybe first one following up on comments you made, Jeff, on the queuing effect you're seeing in DMD.

Jeff: Thank you.

Speaker Change: Our next question comes from the line of Joe Kansas Zero with Piper Sandler. Please proceed with your question.

Speaker Change: Great Hey, everybody. Thanks for taking my questions. Maybe first one following up on those recent comments you made Jeff on the queuing effect Youre seeing in DMD I am wondering if you could elaborate a little bit more on what you mean by the queuing effect than anything you guys can do to shorten the time, a patient spends in that Q and maybe somewhat relatedly what.

Jeff Del Carmen: I wonder if you could elaborate a little bit more on what you mean by the queuing effect and anything you guys can do to shorten the time a patient spends in that queue, and maybe somewhat relatedly what you've seen or heard that has sort of led you to make the decision to separate the sales force. I prefer DAPS than a GammaRay later this year. Thanks, and I have maybe a quick follow-up. Sure, thanks for the question. And, you know, first thing is... competitive landscape within the Duchenne space is a great thing for the patients. And we want to acknowledge In June of last year, Elevitus, as you know, had an expansion of their label so that allowed for boys four years of age and older, regardless of ambulatory status, to be eligible or considered for Elevitus treatment.

Speaker Change: <unk> seen or heard that has sort of led you did make the decision to separate the sales force.

Speaker Change: Preferred absent a gallery.

Speaker Change: Later this year, Thanks, and then I have maybe a quick follow up.

Speaker Change: Yes.

Speaker Change: Sure. Thanks for the question and first thing is.

Speaker Change: A competitive landscape within the Duchenne space is a great thing for the patient and we want to acknowledge that.

Speaker Change: In June of last year allowed us as you know had an expansion in their label. So that allowed for boys four years of age and older regardless of ambulatory status.

Speaker Change: To be eligible or considered for <unk> as treatment.

Jeff Del Carmen: When that happened, a lot of patients and their families and healthcare providers wanted to see if they could be evaluated or are they a fit for a Levitas treatment. So this is just an example. So when that happens, these patients in this treatment team, they do not want to change their treatment, their steroid, if they're on prednisone. They stay on prednisone until they're evaluated and either treated or decided that it's not the right fit for them. If they are treated, then typically what they'll do is they'll wait about 60 days post a Levitas treatment before they will consider switching their steroid.

Speaker Change: When that happened.

Speaker Change: A lot of patients and their families and health care providers wanted to see if they could be evaluated or are they a fit for <unk> as treatment. So this is just as an example, so when that happens these patients in this treatment team they do not want to change their treatment.

Speaker Change: Their steroids, if theyre on prednisone, they stay on prednisone until there are evaluated and either treated or decided that that's not the right fit for them. If they are treated.

Speaker Change: Then typically what they'll do is they'll wait about 60 days post <unk> treatment before they will consider switching their their steroid. So it's that type of killing effect. It's not just those patients that are on a new product is as they are being evaluated for treatment on any of these new products.

Jeff Del Carmen: So it's that type of cuing effect. It's not just those patients that are on a new product. It's as they're being evaluated for treatment on any of these new products. So that's why it may delay, just delay the initiation of a GammaRay. But this happened in June and we've seen it playing through and we expect it to work its way through probably by the middle of this year. So we don't anticipate this being a long-term challenge for a GammaRay. We just see it as a slight delay for initiation to a GammaRay for some time. Is that helpful, Jeff?

Speaker Change: That's why it may delay just delay the initiation of a gambling.

Speaker Change: This happened in June and we've seen it playing through and we expect it to work its way through probably by the middle of this year. So we don't anticipate this being a long term challenge for our Gambari. We just see is a slight delay for initiation to <unk> for some patients.

Jeff: Is that helpful. Jeff.

Jeff Del Carmen: Yeah. That.

Jeff: Yes, yes.

Jeff Del Carmen: So, maybe my follow-up on Phi Kappa, I know historically you guys have said that the epilepsy I've factored some of that. I think you alluded to this a little bit, but any new efforts that you'll employ to maybe slow that erosion trajectory? Yeah, so we see the resiliency there. Obviously, we we have the opportunity to sell the products with under the patent through the end of May, the solid dose, and then the suspension through the end of November. So we're excited about that. And we'll continue to make those efforts. The resiliency is there, in the fact that there's that stickiness that we continually talk about.

Speaker Change: Helpful. Maybe.

Speaker Change: Maybe my follow up on <unk> I know historically, you guys have said that the epilepsy market could be resilient to generics I'm wondering if your guidance for 2025 factor some of that resiliency and I think you alluded to this a little bit, but any any new effort efforts that youll employ to maybe.

Speaker Change: Slow that that erosion trajectory. Thanks.

Speaker Change: Okay.

Yes, so we see the resiliency there obviously, we have the opportunity to sell the products with under the patent through the end of May.

Speaker Change: The solid dose and then the.

Speaker Change: The suspension through the end of November.

Speaker Change: So we're excited about that and we'll continue to make those efforts.

Speaker Change: The resiliency is there.

Speaker Change: And the fact that theres that stickiness that we continually talk about however, once the generics come on the market.

Jeff Del Carmen: However, once the generics come on the market, We will see price erosion and volume erosion. So, we expect to have that opportunity to continue to work with the payers, and we are working with the payers right now, to continue to get favorable position in the marketplace and hold it. We do expect the patients to want the brand, a significant portion of them want the brand, and the payers to want to work with us to hold that favorable position. So, unlike traditional products, traditional retail products that lose the majority of their volume in eight weeks post-patent expiry, we expect to hold on to a considerable amount of our volume throughout the year.

Speaker Change: We will see.

Speaker Change: Price erosion and volume erosion. So we expect to have that opportunity to continue to work with the payers and we are working with the payers right now to continue to get favorable position in the marketplace and hold it we do expect the patients to want the brand as a significant portion of them want the brand and the payers to want to work with us.

Speaker Change: Favorable position.

Speaker Change: Unlike traditional products traditional retail products that lose the majority of their volume in eight weeks post patent expiry, we expect to hold onto a considerable amount of our volume throughout the year.

Speaker Change: Okay.

Jeff Del Carmen: Great, and I wanted to respond. I forgot to, Joe, forgot to respond to your message about splitting up the sales force. So, what we're doing by having a dedicated sales force, it's allowing us more of a focused approach. I mentioned earlier the really crowded competitive landscape for Duchenne, specifically. And when you look at that, a dedicated sales force for Agamri will allow us to optimize engagement with the treating HCP team, so that team across any center of excellence, and support the continued growth. So, that's why we made that decision. Now, also, for Firdapse, when you evaluate the LEMS opportunity with Firdapse, we've talked about this.

Speaker Change: Great and I wanted to respond I forgot to Joe where I got to respond to your your message about the splitting up the sales force.

Speaker Change: So what we're doing by having a dedicated sales force, it's allowing us more of a focused approach.

Speaker Change: I mentioned earlier, the really crowded competitive landscape for Duchenne, specifically and when you look at that a dedicated sales force for our Gam Ray will allow us to optimize engagement with the trading HCP team so that team across to any center of excellence and support to continue.

Speaker Change: Food growth. So that's why we made that decision now also preferred apps when you evaluate the lens opportunity with <unk>. We've talked about this we see significant opportunity for organic growth into the future and by allowing this dedicated or special specialized approach for a gambler or further.

Unknown Executive: We see significant opportunity for organic growth into the future. And by allowing this dedicated or specialized approach for Agamri or for Firdapse, also, that will allow us for those deeper relationships to help find these patients and help these patients get diagnosed and transition Great, thank you. Appreciate you circling back on that. Thanks for taking my question. Thanks, Joe.

Speaker Change: Our preferred apps also that will allow us for those deeper relationships to help find these patients and help these patients get diagnosed and transition to treatment.

Speaker Change: Great. Thank you I appreciate you're circling back on that thanks for taking my question.

Speaker Change: Thanks, Jim.

Speaker Change: Thank you.

Joe Beatty: Our next question comes Joe Beatty with Baird, please proceed with Hi, thanks for taking the questions. The first one is related to a GammaRay. In a competitive DMD marketplace, what are you seeing in terms of generic erosion for MFLAZA? And how much could that impact the opportunity for a GammaRay to grow?

Speaker Change: Our next question comes from the line of Joel Beatty with Baird. Please proceed with your question.

Joel Beatty: Hi, Thanks for taking the questions. The first one is related to a gallery.

Joel Beatty: And the competitive BMD marketplace. What are you seeing in terms of generic erosion for.

Joel Beatty: <unk>.

Joel Beatty: And how much could that impact the opportunity for again ready to grow.

Jeff Del Carmen: Thanks for your question. We have not seen much generic entrant into this, or conversion from, and branded in Plaza at this point. From what we've seen, we haven't seen much. And we don't see that impacting a GAMRI, and we have not really factored that into, or made assumptions based on that, into our forecast for a GAMRI in 2025. We haven't seen any changes to payers, and how they've reacted to a GAMRI because of generic in Plaza. So, that's what gives us confidence that we'll have minimal impact to a GAMRI in 2025. So, Joel, remember, and Plaza's been on market for a couple of years.

Joel Beatty: Thanks for your question, we have not seen much generic.

Joel Beatty: Entrant into this our conversion from and branded and Plaza at this point from what we've seen.

Joel Beatty: Haven't seen much and we don't see that impacting our gallery and we have not really factor that into our made assumptions based on that into our forecast for <unk> in 2025, we haven't seen any changes too.

Joel Beatty: Payers and how they reacted to a gambling because of generic and plaza. So that's what gives us confidence that we.

Joel Beatty: We will have minimal impact to our gam rate in 2020, So Joel remember.

Joel Beatty: And for US has been on market for a couple of years patients. If they are doing step therapy.

Jeff Del Carmen: Patients, if they are doing step therapy, they've tried prednisone, they've tried branded in Plaza, making them step back to a generic in Plaza. not likely to happen. So right now and for the foreseeable future with the steadiness of the patient population. It's not likely to happen, not likely to have a large effect on the ability to take that patient who's already been on prednisone or a version of emplaza, it's just not likely to happen at this time and again for the foreseeable future. Does that make sense? Yeah, that does make sense.

Joel Beatty: Try prednisone, they've tried branded and plaza, making them step back toward generic and plaza.

Joel Beatty: Not likely to happen so right now and for the foreseeable future with the steadiness of that patient population.

Joel Beatty: It's not likely to happen not likely to have a large effect on the ability to take that patient who has already been on prednisone or a version of <unk>, that's not likely to happen at this time and again for the foreseeable future.

Joel Beatty: Does that makes sense.

Speaker Change: That does it makes sense. Thank you and then maybe one last question related to SG&A and <unk>.

Unknown Executive: Thank you.

Unknown Executive: And then maybe one last question related to SG&A in 2025. In the prepared remarks, you mentioned an increase this coming year. Could you quantify that at all? Oh, thanks. We haven't quantified. If you recall, we did not quantify last year either, are expecting the increase as we laid out. And we'll give a little bit more clarity as the year progresses. In part, you know, how long does it take to fill up the positions, etc.

Joel Beatty: 2025, and the prepared remarks, you mentioned an increase.

Speaker Change: Coming here could you quantify that at all.

Speaker Change: Okay.

Speaker Change: Thanks.

Speaker Change: Okay.

Speaker Change: We havent quantified if you recall, we did not quantify last year either.

Speaker Change: We're expecting the increases as we laid out.

Speaker Change: We will give a little bit more clarity as the year progresses.

Speaker Change: How long does it take to fill open positions et cetera.

Unknown Executive: Thanks, Charles.

Unknown Executive: Thank you.

Speaker Change: Makes sense. Thank you.

Speaker Change: Thank you.

Speaker Change: Thank you.

Rohan: Our next question comes from... Leland Gershell. Please proceed with Hey, Leland. Hey, this is Rohan on for Lehman. Thanks for your question. How you doing? Good. How are you? Just a couple questions for me.

Speaker Change: Our next question comes from the line of Marshall with Oppenheimer. Please proceed with your question.

Speaker Change: Hey.

Speaker Change: Hey, this is rolling on for Leland, Thanks payroll question.

You're doing.

Speaker Change: Good how are you just a couple of questions for me.

Richard Daly: Now that we have greater clarity on the Firdep's IP protections moving forward, how does that shape further investment into the franchise? And also, how do you think about the extended commercial runway and how it changes the approach to business development when evaluating different size and structured Great question. Thank you for the questions. So remember, there are still two other litigants out there, right? So we're still working to defend the entire state. And we want to be sure that we're doing that. But the question is a really good one. As we look at the opportunity, should we end up with a full 10 year opportunity or should we end up with a full 10 year opportunity?

Speaker Change: Now that we have greater clarity on the depth IP protections moving forward.

Speaker Change: How does that shape further investment into the franchise and also how do you think about.

Speaker Change: The extended commercial runway and how it changes the approach to business development, when evaluating different sized and structured deals.

Speaker Change: Great question. Thank you for the questions.

Speaker Change: Remember there are still two other.

Speaker Change: Let against out there right so.

Speaker Change: Still working to defend the entire estate and we want to be sure that we're doing that but the questions are really good one as we look at the opportunity should we end up with a full 10 year.

Speaker Change: Opportunity.

Richard Daly: We would look at it as if it's a brand that's going to be on the market for 10 years and you would continue to look and seek opportunities to invest. And as we talked about with an earlier question, you can see us working a bit more aggressively on the oncology side because if there's an opportunity to build that part of the business, which is about 50% of the business, we would continue to do that. We may go back and look at some other research opportunities as well, there may be opportunities there. We have to fully vet those opportunities as well.

Speaker Change: We would look at it as if it's a brand that's going to be on the market for 10 years and you will continue to look and seek opportunities to invest and as we talk to talk about with an earlier question you can see us working a bit more aggressively on the oncology side, because if there is an opportunity to build that part of the business, which is about 50% of the business. We will continue to do.

Speaker Change: Do that.

Speaker Change: One of them.

Speaker Change: We may go back and look at some other research opportunities as well there may be opportunities. There we have to fully vet those opportunities as well, but we'll continue to look at the opportunities and see if there is a way to continue to build the business lifecycle management has many forms it could be through research it could.

Richard Daly: But we'll continue to look at the opportunities and see if there's a way to continue to build a business. Lifecycle management has many forms. It could be through research or development of a product, I should say, or it could be through further commercialization efforts as well. We're going to consider all avenues to fully optimize the value of the asset. Got it. And we saw that the guidance for phicompa reflects some expectations of possible generic erosion. I mean, patients in this space tend to see greater brand adherence than in others. And could you speak to maybe what you're seeing commercially that is driving the lower guidance?

Speaker Change: Development of a product I should say or it could be through further commercialization efforts as well. So we're going to consider all avenues to fully optimize the value of the asset.

Speaker Change: Got it and we thought that the guidance for flat comp.

Speaker Change: Reflects some expectations as possible generic erosion.

Speaker Change: I mean in patients in this phase tend to see greater brand adherence than in others and could you speak to maybe what you're seeing commercially that is.

Speaker Change: Driving the lower guidance.

Richard Daly: So what will happen, so we'll drive below guidance, is we'll be able to maintain the trend that we're on. The product is, my standard comment is, it's like the mailman, it delivers. It just keeps delivering. It'll deliver through the end of May. Should a generic come on the market in June, it'll be fine. But once it goes off patent, some patients are price sensitive, that's the nature of patients. Some patients are brand sensitive, they'll want to maintain, and that's especially true in the, I'm sorry, in the epilepsy market. There will be some contracting we'll do with payers to to maintain our position, that will be an erosion of price, and we will lose some volume.

Speaker Change: So what will happen so we'll drive the lower guidance as well it will be able to maintain the trend that we're on the product is.

Speaker Change: Mike My standard comment is it's like the mailman at deliver so it just keeps delivering it will deliver through the end of May should.

Speaker Change: Should a generic on the market in June it'll be fine.

Speaker Change: But once it goes off patent some patients are price sensitive thats the nature of patients. Some patients are brand sensitive they'll want to maintain and that's especially true in the generic im sorry in the epilepsy market.

Speaker Change: <unk>.

Speaker Change: There will be some contracting will do with <unk>.

Speaker Change: <unk> two.

Speaker Change: To maintain our position that will be an erosion of price and we will lose some volume so there'll be a mix of price and volume, but as I said in response to an earlier question.

Felix Ampma: So there'll be a mix of price and volume. But as I said, in response to an earlier question, It will be much more sustainable than you would see with a typical retail product. That is the nature of epilepsy products. So that's our expectation at this point in time, and we will continue to give updated guidance as the market evolves. Thank you. Congrats on another great quarter. Thanks. Thank you. Our next question comes from the line. Logan Undyne with Steven. Please proceed with your Congrats on the call. This is Felix Ampma, Inc. for Sudan Luganathan.

Speaker Change: It will be much more sustainable than you would see with a typical retail product that is the nature of epilepsy products.

Speaker Change: So that's our expectation at this point in time, and we will continue to give updated guidance as the market evolves.

Speaker Change: Thank you congrats on another great quarter.

Speaker Change: Thank you.

Speaker Change: Okay.

Speaker Change: Thank you.

Speaker Change: Our next question comes from the line of Sudan.

Speaker Change: With Stephens. Please proceed with your question.

Speaker Change: Congrats on the call. This is bill.

Speaker Change: Each for Sudan Luca Nathan.

Richard Daly: I have two questions, one on Fairdata. Given the fact that the product has done very well in the marketplace, how well have you penetrated the LEMS market? If you can give color on the percent, that would be very helpful. And then one other question is... Summit Trial for Agami Rae. If you can give us potential legal expansion opportunities that you can, it's out there, that would be helpful for us to model the company very well. Sorry, the second part of the question was Summit. Was it Summit? Okay, yeah. So in January at J.P. Morgan, we gave a market valuation for LEMS at over, and this is, I just want to be really clear.

Speaker Change: <unk>.

Speaker Change: Two questions one on bad debts.

Speaker Change: Given the fact that the product has done very well in the marketplace.

Speaker Change: Well have you penetrated.

Speaker Change: <unk> market.

Speaker Change: You can give color on the percent.

Speaker Change: That would be very helpful.

Speaker Change: And then one about question it's on the.

Speaker Change: Summit trial, so again Murray.

Speaker Change: If you can give us potentially new exploration opportunities that you can.

Speaker Change: It's out there that would be helpful for us to model the company very well.

Speaker Change: So the second part of your question was summit was it some it okay.

Speaker Change: So in January at Jpmorgan, we gave a market valuation for lemons at over and this is I just want to be really clear. This is at today's prices today's prices and a conservative view of the market. Assuming there are 3600 patients in the market and the addressable size of the market not the total 100%.

Richard Daly: This is at today's prices, today's prices and a conservative view of the market, assuming there are 3,600 patients in the market and the addressable size of the market, not the total 100% of the market. Addressable patients within the market. The market is valued at over a billion dollars. The LEMS market is valued over a billion dollars. So to just give a very simple answer, what's our market penetration? Last year we sold $306 million. So our market penetration would be about 30%. We believe there's tremendous upside in this market. And given the settlement with Teva, should we prevail in the other two suits, we have a runway, is prevail in a similar way with the other two suits, we have a runway of 10 years and we're all alone.

Speaker Change: Of the market addressable patients within the market the market is valued at over $1 billion.

Speaker Change: The lens market is valued over $1 billion.

Speaker Change: So to just give a very simple answer once our market penetration last year, we sold $306 million.

Speaker Change: So our market penetration would be about 30%.

Speaker Change: We believe there is tremendous upside in this market and given the settlement with Teva should we prevail in the other two suits we have a runway.

Speaker Change: Prevail in a similar way with the other two suits, we have a runway of 10 years and we're all alone.

Gary Ingenito: So we think there's tremendous upside in this market. And we intend to invest appropriately to see that upside come to fruition. I'm on summit. We intend to use the summit study to see if we can make it, clarify the differentiation of GAMRI from other steroids in the market. We believe it's a unique steroid, and we will invest appropriately in that study. Whether or not that can result in a label change, I'll let Gary address that, but there's obviously opportunities to publish, whether it's through posters or publications and in journals or not. But Gary, do you want to take the question?

Speaker Change: So we think there's tremendous upside in this market and we intend to invest appropriately to see that upside come to fruition.

Speaker Change: On summit.

Speaker Change: We intend to use.

Speaker Change: The summit study to see if we can make it a clarify the differentiation of the gamut from other steroids in the market. We believe it's a unique steroid.

Speaker Change: And we will invest appropriately in that study whether or not that can result in a label change I'll, let Gary address that but there is obviously opportunities to publish whether it's pulp posters or publications in.

Speaker Change: And journals or not but Gary do you want to take the question.

Gary Ingenito: Sure. Thank you. As Rich said, we really are looking to get the long-term safety information that we expect to generate with Summit out into the public. The fastest way to do that is through posters, presentations, abstracts, publications. Label expansion depends upon the overall We certainly have planned and look forward to the study, but having that potential, the way it is designed, but will depend upon what we see as we go along. However, I believe that the information to be generated on the different parameters of, you know, bone health, growth velocity, cardiac safety, fractures, cataract formation will all be very important data to make available as soon as it is ready to the prescribing population.

Speaker Change: Sure. Thank you.

As rich said, we really are looking to get the long term safety information that we expect to generate with summit out into the public.

Speaker Change: Fastest way to do that is through poster.

Speaker Change: Posters presentations abstracts.

Speaker Change: Publications.

Speaker Change: Label expansion depends upon the.

Speaker Change: Overall.

Speaker Change: Strength in the mountain data.

Speaker Change: We certainly have planned and look forward to the study, but having that potential the way it is designed.

Speaker Change: But it will depend upon.

Speaker Change: What we see as we go along however, I believe that the information to be generated on the different parameters of bone health growth velocity cardiac safety fractures cataract formation will all be very important data.

Speaker Change: To may.

Speaker Change: We make available as soon as it is ready to the prescribing population.

Gary Ingenito: Thank you. Thank you very much. Thank you. We have reached the end of the question and answer session and this also concludes today's You may disconnect your lines at this time. We do thank you for your participation.

Kerry: Thanks Kerry Thank you thank.

Speaker Change: Thank you very much.

Speaker Change: Thank you.

Speaker Change: Okay.

Speaker Change: Thank you.

Speaker Change: <unk> reached the end of the question and answer session and this also concludes today's call.

Speaker Change: You may disconnect your lines at this time, we do thank you for your participation.

Speaker Change: Okay.

Speaker Change: Okay.

Speaker Change: [music].