Q4 2023 Catalyst Pharmaceuticals Inc Earnings Call

Operator: Hello and welcome to the Catalyst Pharmaceuticals Inc. fourth quarter and full year 2023 Financial Results Conference calling webcast. If anyone should require operator assistance, please press star zero on your telephone. A question and answer session will follow the formal presentation. You can enter the question queue at any time by pressing star 1 on your television.

Hello, and welcome to the catalyst Pharmaceuticals, Inc, fourth quarter and full year 20, twenty-three financial results conference call and webcast. If anyone should require operator assistance. Please press stars zero on your telephone keypad.

Question and answer session will follow the formal presentation. He may be placed into question cute any time by pressing star one on your telephone keypad. We ask you. Please ask one question and one follow up then returned to the queue. As a reminder, this conference is being recorded it's now my pleasure to turn the call over to CFO My Cal, but please go ahead.

Operator: We ask that you please ask one question and one follow-up, then return. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to you. Go ahead.

Unknown Executive: Thank you. Good morning, everyone. And thank you for joining our conference call to discuss Catalyst's fourth quarter and full year 2023 financial results and business highlights. Leading the call today is Richard Daly, CEO. We are also joined by Dr. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer, and Jeffrey Del Carmen, our Chief Commercial Officer. Additionally, for the Q&A session, Dr. Gary Ingenito, our Chief Medical and Regulatory Officer, will be available for questions. Before we begin, I would like to remind you that in our remarks this morning and in the Q&A session, we will make statements about expected future results, which may be forward-looking statements for purposes of federal securities laws. These statements 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.

Mike.

Thank you good morning, everyone and thank you for joining our conference call to discuss catalyst fourth quarter and full year of 2023 financial results in business highlights.

He didn't call today is Richard Daley C E O.

We're also joined by Doctor Steven Miller, our Chief operating Officer, and Chief Scientific Officer in Jeopardy del Carmen are cheap commercial officer further for the Q&A assertion Doctor, Gary and tomato, our chief medical and regulatory officer will be available for questions.

Before we begin I would like to remind you that in our remarks. This morning and in the Q&A assertion, we will make statements about expected future results, which may be forward looking statements for purposes of federal Securities laws.

These statements really to our current expectations estimates and projections and are not guarantee of future performance. They involve risks uncertainties and assumptions that are difficult to predict and may proved not to be accurate.

Richard John Daly: Accurate 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 2023 Annual Report on Form 10-K. At this time, I'll turn the call over to Richard. Thanks, Mike, and welcome everyone to the call. First, I'd like to say that our entire team is proud of the work that we do on behalf of the orphan and rare disease communities that we serve, and we're especially excited to be speaking to you today on Rare Disease Day. 2023 was an outstanding year for Catalyst, and we are proud of all that the team achieved.

Actual results may vary from the expectations contained an hour 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 twenties twenty-three annual report on Form 10-K at this time I'll turn the call over to rich.

Right and walked every once of the call.

First I'd like to say that our entire team is proud of the work that we do on behalf of the orphan and rare disease communities that we serve and we're especially excited these speaking you to today on rare disease day.

2023, with an outstanding year for catalyst.

Of all that the team has achieved.

Richard John Daly: We are pleased to highlight the progress we have made during this transformational year that we have just completed, and we are proud to provide insight into the year ahead. But before the team dives into that, I'd like to offer some high-level comments. We operate our business around four key pillars. First, commercial execution with a supreme focus on patient care and access. Second, Portfolio Expansion through Business Development. Third, Lifecycle Management and Partnership. And finally, financial discipline.

We are pleased to highlight the progress we have made during this transformation of the year that we just completed.

Proud to provide insight into the year ahead.

But before the team size into this [laughter] like the office of high level of comments.

Got buried or business around four key pillars.

First commercial execution with Supreme focus on patient care and access.

Second portfolio expansion two business development.

Third lifecycle management and partnerships.

And finally financial discipline.

Our discussion today will provide you with updates on each of these areas.

Richard John Daly: Our discussion today will provide you with updates on each of these areas. 2023 was a transformational year for Catalyst. Let's start with our first pillar, our commercial execution. The core of Firdat's business remains strong, as evidenced by our sustained organic growth.

2023 was a transformational year for catalyst.

Let's start with our first teller or commercial execution.

The core Firdapse business remains strong evidenced by our sustained organic growth.

Richard John Daly: We continue to reach more patients in this market by working diligently to increase awareness of VirDAPS and the disease it treats. Lab, further enhance our business. In 2023, we expanded our commercial portfolio with our acquisition of Phi Kappa. Seamless integration of the Phi Kappa franchise into our company has yielded promising results.

You need to reach more patients in this market by working diligently to increase awareness of Firdapse and the disease. It treats.

Lamps.

To further enhance our business in 2023, we expanded our commercial portfolio with our acquisition of fly copper seamlessly.

Seamless integration of the Phi Kappa franchise into our company has yielded promising results were pleased with the products performance.

Richard John Daly: We're pleased with the product's performance. This edition enriches our portfolio by enhancing income diversity, fostering stable revenue streams, and fortifying our balance sheet in preparation for future acquisitions. Our second pillar, portfolio expansion. In addition to FICOMPA, in the third quarter of 2023, we licensed the North American rights to a GAMRI, a U.S. NDA-filed asset for Duchenne's muscular dystrophy. Agamery was approved in the fourth quarter, and we remain on track for the launch of Agamery before the end of the first quarter of 2024. We're excited to have this innovative product in our portfolio. More importantly, we know through our outreach to patients, caregivers, and providers that the Duchenne community is excited as well.

This edition and wishes enriches our portfolio by enhancing income diversity, fostering stable revenue streams, and fortifying our balance sheet and preparation for future acquisitions.

Our second pillar portfolio expansion.

In addition to vie copper in the third quarter of 2023, we licensed in North American rights to a gallery.

U S NDA filed asset for Duchenne muscular dystrophy.

<unk> was approved in the fourth quarter and we remain on track for the launch of a camry before the end of the first quarter 2024.

We're excited to have this innovative product in our portfolio more importantly, we know through our outreach to patients caregivers and providers that the duchenne community as excited as well.

We are well prepared prepared for the successful launch of a gammy, providing further revenue growth and diversification, while addressing a significant unmet need for improved therapeutic options for patients.

Richard John Daly: We are well prepared for the successful launch of a GAMRI, providing further revenue growth and diversification while addressing a significant unmet need for improved therapeutic options for inpatients. The future potential for Agamri represents an opportunity for incremental growth that can continue to propel the company forward. We are committed to our buy and build strategy, and our results bear testament to its success. In 2023 alone, we allocated approximately $300 million toward acquiring assets without debt, bolstering the company's commercial position.

The future potential for a gambler. He represents an opportunity for incremental growth that can continue to propel the company forward.

We are committed to buy and build strategy and our results Bear Testament to its success.

And 2000 twenty-three alone be allocated approximately $300 million toward acquiring assets without that.

During the company's commercial position.

Furthermore, our recent common stock offering combined with a robust balance sheet underscores our ability to persistently pursue strategic investments aimed at expanding and diversifying our portfolio.

Richard John Daly: Furthermore, our recent common stock offering combined with our robust balance sheet underscores our ability to persistently pursue strategic investments aimed at expanding and diversifying our portfolio. Jeff will provide an overview of our performance in 2020-23 with respect to commercializing FertApps and FICOMPA and our plans for our portfolio in 2024, including GAMRI, in his section this morning. Pillar number three.

Jeff will provide an overview of our performance in 2000 2023 with respect to commercializing Firdapse and <unk> and our plans for our portfolio of 2024, including Camry and his section this morning.

The teller number three.

Richard John Daly: Lifecycle Management and Partnerships. We await the FDA's decision on the expansion of Firdaf's label to include 100 milligram dosing, which is expected in the second quarter of 2024. We believe this has the potential to provide an important option for patients who live with LEMD. We are also making great strides in our Ex-U.S. partnerships. Japanese regulatory authorities have accepted Dido's NDA for FertApps, and we expect a decision on their application later this year. This also bodes well for expanding our ex-U.S. opportunities as the Japanese NDA acceptance triggers the expansion of our territorial rights for FRTAPs in certain APAC and LATAM markets. Finally, pillar number four.

Lifecycle management and partnerships.

We await the Fda's decision on the expansion of the Firdapse label to include 100 milligram doses, which is expected in the second quarter of 2024.

We believe this has the potential to provide an important option for patients who live with lamps.

We are also making great strides in R X U S partnerships.

Japanese regulatory authorities have accepted Dinos NDA preferred apps and we expect a decision on their application later this year.

This also bodes well for our expanding for expanding our X U S opportunities as the Japanese NDA acceptance triggers the expansion of our territorial rights for Firdapse in certain APAC and Latam markets.

Finally tell her number four.

Richard John Daly: We are well known for our financial discipline, and we plan to continue to deliver the rigor you have come to expect. Mike will go into great detail in his section of the call. Now to our 2022 results. We delivered outstanding performance in 2023, exceeding our guidance for the year, delivering record total revenues, both organically and through the expansion of our product portfolio. These results will continue to drive our momentum as we move through 2024. Our full-year total revenue for 2023 was $398.2 million, an 85.9% increase year over year compared to $214.2 million in 2022. Additionally, we achieved record fourth quarter total revenues of $110.6 million, representing an 82% increase compared to $60.8 million in quarter four of 2022. We achieved our results by delivering 21% revenue growth for the full year of 2023 for FertApps to sales of $258.4 million and delivering $138.1 million in sales for FICOMP. We are proud of these results, and we thank our team for delivering such a strong performance.

We are well known for our financial discipline, and we plan to continue to deliver the rigor you have come to expect.

We'll go into great detail and his section of the call.

Natural of 2023 results.

We delivered outstanding performance in 2023 exceeding our guidance of the year delivering record total revenues, both organically and through expansion of our product portfolio.

These results will continue to drive our momentum as we move through 2024.

Our full year total revenue for 2023 or $398 million too.

A million dollars and 85.9% increase year over year compared to $214.2 million in 2022.

Additionally, we achieved record fourth quarter total revenues of $110.6 million, representing 82% increase compared to $68 million in quarter four of 2022.

We achieved our results by delivering 20, 21% revenue growth for the full year of 2023 referred apps.

Sales of $258.4 million and delivering $138.1 million in sales reflect comma.

We are proud of these results and we thank our team for delivering such a strong performance.

Looking ahead to 2024 are full year 2024 guidance reflects our confidence outlook protecting of sustained growth and strategic advancements in line with our long term objectives.

Richard John Daly: Looking ahead to 2024, our full year 2024 guidance reflects our confident outlook, projecting sustained growth and strategic advancements in line with our long-term objectives. We believe that 2024 will provide opportunities for continued growth of our portfolio, and we are forecasting full year total net revenues of between $455 and $475 million, representing a 14 to 19% increase in our total net revenues compared to 2023. To provide you with more color on each of these pillars, I'll turn the presentation over to the team. Let's begin with Jeff Del Carmen, our Chief Commercial Officer. Jaffa.

We believe that 2024 will provide opportunities for continued growth of our portfolio and we are forecasting full year total net revenues of between 455 and $475 million, representing a 14 to 19 per cent increase in our total net revenues compared to 2023.

To provide you with more color on each of these pillars I will turn the presentation over to the team.

Let's begin with Jeff Delcarmen, our Chief commercial Officer, Jeff.

Thanks, Rich and good morning, everyone first I wanted.

Jeffrey Del Carmen: Thanks, Rich, and good morning, everyone. First, I want to commemorate Rarity's Day and all the people touched by Rarity's Day. We are pleased with the outstanding performance delivered in 2023, highlighted by full-year combined total revenues of $398.2 million, exceeding the upper end of guidance of $395 million. This remarkable performance was fueled by Firdap reaching an all-time high of $258.4 million, and the consistent strong contribution from Phi Kappa, which generated $138.1 million in net revenue. Let's start by reviewing our advancements with Firdapse, the only evidence-based, FDA-approved treatment for Lambert-Eaton myasthenic syndrome.

These day and all the people touched by rare diseases.

We are pleased with the outstanding performance delivered in 2000 twenty-three highlighted by full year combined total revenues of $398 $2 million exceeding the upper end of guidance of $395 million.

This remarkable performance was fueled by Firdapse, reaching an all time high of $258.4 million in.

In the consistent strong contribution from by comma, which generated $138 $1 million in net revenues.

Let's start by reviewing our advancements with perhaps the only evidence based F. D. A approved treatment for Lambert eaten Myasthenic syndrome.

In the fourth quarter net revenues amounted to 69 $8 million showcasing a remarkable year on year growth 15%.

Jeffrey Del Carmen: In the fourth quarter, net revenues amounted to $69.8 million, showcasing a remarkable year-on-year growth of 15%. Moreover, the overall net revenues of 2023 displayed a robust 20.8% growth compared to the previous year, propelled by consistent initiation of new patients and an annual low discontinuation rate trending below 20%, consistent with previous years and Internal Expectations. Prescription approval rates exceeded 90% for all types of payers, including government and private commercial insurers.

Moreover, the overall net revenues of 2023 displayed a robust 20.8% growth compared to the previous year propelled by consistent initiation of new patients and an annual low discontinuation rate trending below 20%.

System with previous years and internal expectations.

Prescription approval rates exceeded 90 per cent for all types of payers, including government and private commercial insurers.

Jeffrey Del Carmen: Patients enrolled in Catalyst Pathways, including those with Medicare coverage and accessing third-party foundation assistance, experienced an average monthly co-pay of less than $2.00. We are confident that Firdat's organic growth in 2024 will be between 15% and 20%, building upon the momentum from 2023. This growth will primarily be fueled by several key factors.

Patients enrolled in catalyst pathways, including those with Medicare coverage accessing third Party Foundation assistance experienced an average monthly co pay of less than $2.

We are confident in the continued firdapse organic growth in 2024 will be between 15% and 20% building upon the momentum from 2023.

This growth will primarily be fueled by several key factors.

Jeffrey Del Carmen: Conversely, the conversion of a portion of the 500 identified LEMS patients to Firdaps treatment will play a significant role. Additionally, the anticipated approval of the 100 mg expanded label in June 2024 should help contribute to this growth trajectory, providing patients the opportunity for a higher daily dose when appropriate. Furthermore, the expansion of educational programs targeting small cell lung cancer LEMS healthcare providers is poised to accelerate LEMS diagnosis.

Firstly the conversion of a portion of the 500 identified lens patients to Firdapse treatment will play a significant role.

Additionally, the anticipated approval of the 100 milligram expanded label in June 2024 should help contribute to this growth trajectory, providing patients the opportunity for a higher daily dose when appropriate.

Furthermore, the expansion of educational programs targeting small cell lung cancer lens health care providers is poised to accelerate lamps diagnosis rates <unk>.

Jeffrey Del Carmen: Lastly, our efforts to broaden the addressable LEMS market through increased BGCC antibody testing will further bolster growth prospects. As a reminder, we shared an abstract at the World Conference on Lung Cancer in September, which projected that the prevalence of LEMS in the United States is at least 3,600. Data suggest it could potentially reach 5,400 individuals. This figure marks a notable rise from the previously estimated prevalence of 3,000. Our estimate stems from a thorough analysis of real-world data, particularly emphasizing the prevalence of LEMS diagnosis among patients with small cell lung cancer. Presently, we gauge that over 80% of small cell lung cancer lens patients remain undiagnosed, indicating a substantial growth opportunity.

Lastly, our efforts to broaden the addressable lands market through increased Bgc's antibody testing.

Further bolster growth prospects.

As a reminder, we shared an abstract at the World conference on lung cancer in September which projected that the prevalence of lambs in the United States is at least 3600.

Data suggests it could potentially reach 5400 individuals.

This figure marks a notable arise from the previously estimated prevalence of 3000.

Our estimate stems from a thorough analysis of real world data, particularly emphasizing the prevalence of lands diagnosis among patients with small cell lung cancer.

Presently we gauge that over 80% of small cell lung cancer lens patients remain on diagnosed.

Indicating a substantial growth opportunity.

Now I'd like to share some key updates regarding our progress with <unk>. The commercialization of fight Champa has surpassed our initial expectations in May 2023, we seamlessly integrated by Champa into our product offerings as a strategic and highly accretive product.

Jeffrey Del Carmen: Now I'd like to share some key updates regarding our progress with FICOMPA. The commercialization of FICOMPA has surpassed our initial expectations. In May 2023, we seamlessly integrated Vycompa into our product offerings as a strategic and highly accretive product. We actively engage with health care providers and key opinion leaders, expanded our outreach to establish vital partnerships with patient advocacy groups to increase awareness and further our mission, and fostered valuable relationships that have played a significant role in PhyCOMPA's success. FICOMPA's net revenues have exceeded the anticipated full-year estimate of $130 million, reaching a total product revenue of $138.1 million, surpassing expectations by 6%.

We actively engaged with healthcare Provider's name T opinion leaders expanded our outreach to establish vital partyless partnerships with patient advocacy groups to increase awareness and further our mission.

And fostered valuable relationships that have played a significant role in <unk> success.

By <unk> net revenues have exceeded the anticipated full year estimate of 130 million, reaching a total product revenue of $138.1 million, surpassing expectations by 6%.

Jeffrey Del Carmen: This achievement was propelled by a robust end to the year, with revenues for Q4 2023 reaching $39.3 million. We forecast 2024 FICOMPA net revenues will be approximately $130 million to $135 million based on changes in gross to net. When products transition to companies with a smaller portfolio, like we experienced with Ficompa, you typically encounter higher fees from service providers such as Wholesale.

This achievement was propelled by robust and to the year with revenues for Q4, 2023, reaching $39.3 million.

We forecast 2024 by common net revenues will be approximately $130 million to $135 million based on changes in gross Tonight.

When products transition to companies with a smaller portfolio like we experienced with <unk> you typically encounter higher fees from service providers such as wholesalers.

Jeffrey Del Carmen: Let's turn to Agamri, a promising novel anti-inflammatory corticosteroid aimed at addressing a significant gap in treatment for the estimated 11,000 to 13,000 boys living with Duchenne muscular dystrophy or DMD. As previously disclosed, we are on track for a commercial launch in the first quarter of 2024. Agamri will be integrated into our neuromuscular franchise, capitalizing on the team's proven capabilities, commercial expertise, and experience. We have finalized the recruitment of 10 commercial personnel to bolster the impending launch, primarily focusing on marketing and patient service. Our existing neuromuscular sales force, comprising 16 regional account managers and two area business directors, will assume responsibility for both FertApps and Agamri.

Let's turn to a gambling a promising novel anti inflammatory corticosteroid aimed at addressing a significant gap in treatment for the estimated 11000 to 13000 boy living with Duchenne muscular dystrophy or D. M D.

As previously disclosed we are on track for a commercial launch in the first quarter of 2024.

<unk> will be integrated into a neuro muscular franchise capitalizing on the teams proven capabilities commercial expertise and experience.

We have finalized of recruitment of 10 commercial personnel to bolster the impending launch primarily focusing on marketing inpatient services.

Our existing neuro muscular salesforce, comprising 16 regional account managers and to area business directors will assume responsibility for both firdapse in a gambling.

Jeffrey Del Carmen: Furthermore, a GAMRI will benefit from the support of our top-notch Catalyst Pathways program, ensuring that all eligible patients have access to the product. Based on the feedback from our constituents and analysis of the DMD market, the wholesale acquisition cost of a GAMRI will be at a slight discount to Enplaza. We will implement the same financial programs as we have for Firdeps with the goal to ensure that the average out-of-pocket cost per patient will be less than $2 per month.

Furthermore, a gambling will benefit from the support of our top notch catalyst pathways program, ensuring that all eligible patients have access to the product.

Based on the feedback from our constituents and analysis of the D. M. D market. The wholesale acquisition cost of a gallery will be at a slight discount two n's Plaza, we will implement the same financial programs as we have preferred apps with a goal to ensure the average <unk>.

Kit cost per patient will be less than $2 per month.

More details on the commercial launch will be available in the coming weeks.

Jeffrey Del Carmen: More details on the commercial launch will be available in the coming weeks. We began accepting pre-commercial, launched new patient enrollments on December 1st, 2023, based on the volume of new patient enrollments and observed pent-up demand. Our 2024 Net Revenue Guidance for Agamri is between $25 million and $30 million. In conclusion, we are extremely proud of our achievements in 2023 and maintain strong confidence in meeting our targets for 2024. As we prepare for the launch of a GAMRI, we will leverage our established commercial proficiency. I express sincere appreciation to the entire Catalyst team for their unwavering dedication to patients, and I eagerly look forward to a prosperous 2024. I will now turn the call over to Dr. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer, for an update on R&D activities. Thank you, Jeff.

We began accepting pre commercial.

Launch new patient enrollments on December 1st 2023.

Based on the volume of new patient enrollments and observed pent up demand.

2024, net revenue guidance for a camry is between $25 million and $30 million.

In conclusion, we are extremely proud of our achievements in 2023 and maintain strong confidence in meeting our targets for 2024 as we prepare for the launch of a <unk>, we will leverage our established commercial proficiency.

I express sincere appreciation to the entire catalyst T for their unwavering desert dedication to patients and I eagerly look forward to a prosperous 2024 ahead.

I will now turn the call over to Dr. Steven Miller, our Chief operating Officer, and Chief Scientific Officer for an update on R&D activities.

Thank you Jeff.

Steven Miller: I would first like to discuss our development efforts to increase the indicated maximum dose of Firdeps, as previously reported in October of 2020. The FDA accepted for review the company's supplemental new drug application to increase the indicated maximum 80mg daily dosage of Firdeps to 100mg for the treatment of Lambert-Eaton Mycinic Syndrome (LAM). Catalyst continues to anticipate approval of the application on or about June 4, 2023, which is the PDUFA action date granted by the FDA. Additionally, about 40% of patients are on the current indicated maximum dose of 80 mg per day, and their physicians would like the option to increase the daily dosage above 80 mg per day based upon disease progression.

I would first like to discuss our development efforts to increase the indicated maximum dose of photos as previously reported in October of 2023.

<unk> accepted for review the company's supplemental the new drug application to increase the indicated maximum 80 milligram daily dosage referred us to 100 milligrams for the treatment of <unk> syndrome for lunch.

Artless continues to anticipate approval of the application on or about June 4th 2023.

To produce a extra biggs granted by the FDA.

About 40% of patients are on the current indicated maximum dose of 80 milligrams per day and their physicians would like the option to increase the daily dosage above 80 milligrams per day based upon disease progression catalyst believes that this expensive of deferred ups label, if approved would address an important opportunity for coaches and their health care provider.

Steven Miller: Catalyst believes that this expansion of the Firdeps label, if approved, would address an important opportunity for patients and their health care providers and may lead to about a 5-10% increase in the prescribed average daily dose of Firdeps over time. In 2023, we focused on expanding our intellectual property portfolio. Resulting in the granting of two additional patents for Firdat. These patents were issued in 2023 and 2024, bringing the total number of patents protecting Firdaps to. This further strengthens our intellectual property estate for Firdeps, which has patent protection until 2036.

<unk> and may lead to about a 5% to 10% increase prescribed average daily dose of Firdapse overtime.

2023, we focused on expanding our intellectual property portfolio preferred apps, resulting in the granting of two additional times referred US. These patents were issued a 2023 and 2002 won't before bringing the total number of patents protecting <unk>.

This further strengthens our intellectual property estate for <unk>, which has patent protection to 2037.

Steven Miller: Catalyst expansion to global markets is continuing to progress. Our partner in Japan, Daito Pharma, achieved a notable milestone in December of 2023, having successfully submitted their NDA for Firdaps to the Japanese PM. We anticipate a priority review cycle time of nine months, and if approved, a potential launch in early 2025, with 10 years of market exclusivity in Japan following.

Carlos expansion to global markets.

Going to progress our partner in Japan go to a form of a cheap and notable milestone in December of 2023, having successfully submitted their M. B a preferred us to the Japanese P M Dear.

We anticipate a priority review cycle time of nine months and if approved a potential launched in early 2025 or 10 years of market exclusivity in Japan after.

Steven Miller: Next, I'll move on to our newest approved product, Agamri, for the treatment of Duchenne muscular dystrophy, or DMD. GAMRI was approved on October 26 of last year and was granted new chemical entity exclusivity and orphan drug exclusivity, conferring market exclusivity to October 2027 and 2030, respectively. This FDA-granted exclusivity is augmented by six orange book-listed patents that provide protection to 2040 for As part of our ongoing effort to maximize value, we continue to seek opportunities to strengthen GAMRI's patent protection and explore new indications for labeling. Gamre or Vomorla in clinical studies has shown efficacy for the treatment of DMD patients while holding the potential for a reduction in the burden of steroid-associated side effects compared to steroids.

Next I'll move onto our newest approved product of January for the treatment of Duchenne muscular dystrophy or dam D.

<unk> was approved October 26th of last year, and was granted new chemical entity exclusivity ad or for drug exclusivity conferring market exclusivity to October 2077 at 2030, respectively.

Does this FDA granted exclusivity is augmented by six Orange book was the Titans to provide protection to 2040 for again.

As part of our ongoing effort to maximize violence.

We will continue to seek opportunities to strengthen the grammars protection and explore new indications for labor.

Memory over moral and clinical studies have shown efficacy for treatment of the empty patients were holding the potential for a reduction in the burden of steroid associated side effects compare.

This includes the potential for notable benefits for bone health growth and behavioral outcomes based on preliminary data out of your estimated 11000 to 13000 D. M D patients in the U S roughly 90% have undergone corticosteroid treatment at some stage.

Steven Miller: This includes the potential for notable benefits for bone health, growth, and behavioral outcomes based on preliminary data. Of the estimated 11,000 to 13,000 DMD patients in the U.S., roughly 90 percent have undergone corticosteroid treatment at some stage. Presently, it is estimated that about 70% of DMD patients currently under treatment receive steroids. Steroids serve as the cornerstone of DMD therapy, highlighting the pressing demand for a more tolerable steroid. The short-term safety and efficacy of Amoralone were demonstrated in a 24-week randomized double-blind placebo and active-controlled study, and it was well tolerated and was associated with maintenance of muscle strength and function.

Presently it is estimated that about 70% of the empty patients currently under treatment received stewards steward serve as the cornerstone of the empty therapy, highlighting the pressing demand for a more tolerable spirit.

The short term safety and efficacy of a moral loan was demonstrated in a 24 week.

Double blind placebo and access control study and it is well tolerated and was associated with maintenance of muscle strength and function.

Steven Miller: To determine what specific safety benefits a GAMRI may have, if any, relative to other approved corticosteroids, Catalyst is investing in a registry to study the long-term safety and quality of life in males with DMD that are treated. As this data is collected and analyzed, Catalyst will periodically seek to update the IGAMRI prescribing information with the latest information regarding the safety of the drug based upon FDA Education and information on new and unique products is the focus of Catalyst's medical science liaisons for our company. Critical support to the medical community by providing information that is in the public domain to the medical community in order to educate them on these rare disease states and on the academic research that may have been published about these medications. This assists healthcare providers in selecting the best treatment for their patients. Memorial Law has generated a high level of interest within the healthcare community. The Neuromuscular MSL team has been engaging with the DMD medical community since GAMRI's approval in October of last year. There are numerous publications on Glamoriland's pharmacology and effect in BMD patient populations.

Determine what specific safety benefits of January may have relatives.

Relative to other approved corticosteroids Cabalist is investing in a registry to study the long term safety and quality of life and males with the empty that are treated with a girl.

As this data is collected and analyzed catalysts will periodically seek to update for your camry prescribing information with the latest information regarding the safety of the drug based upon FTA guidance documents from real World data.

Education and information on <unk> and the big products is the focus of catalyst medical science <unk> for our conference.

Critical support to the medical community by providing information that is in the public domain to the medical community in order to educate them on these rare disease states and on the academic research that may have been published about these medications.

This assess healthcare providers in selecting the best treatment for their patients Memorial has generated a high level of interest within the healthcare community.

Neuromuscular MSL team <unk> with the BNP medical generative since exam or his approval in October of last year.

There are numerous publications uncle Marlins pharmacology in effect at the empty patient population.

Michael W. Kalb: I'll now turn the call over to Mike Howe, our Chief Financial Officer. Thank you, Steve. Catalyst's fourth quarter and full year 2023 financial performance resulted in another record-breaking year, driven by exceptional execution by all facets of our business. In addition to our outstanding results, the company successfully closed two transactions in 2023. The acquisition of the U.S. rights to Pycompa and the North American license for Gamma.

Now turn the call over to Martel, our Chief Financial Officer.

Thank you, Steve Cuddles fourth quarter and full year of 2023 financial performance resulted in another record breaking year.

Driven by exceptional execution by all facets of our business.

In addition to our outstanding results. The company has successfully closed to transactions from 2023, the acquisition of the U S rights to pry Champa and the North American license for gambling.

Both transactions provide the company with additional opportunity to continue to create incremental net positive cash flow through disciplined execution.

Michael W. Kalb: Both transactions provide the company with additional opportunities to continue to create incremental net positive cash flow through disciplined execution. I'd like to take a moment to reiterate some of the key accounting implications and accounting treatment of the GammaRay transaction. As a result of the FDA approval of Agamri on October 26, 2023, we made a $36 million milestone payment to Santera in the fourth quarter of 2023, which was capitalized on the balance sheet as an intangible asset and will be amortized on a straight line basis over its estimated useful life of 10 and a half years. I would like to reinforce that, based on the timing of the IGAMRI approval, amortization Catalyst also made a strategic equity investment in Fenthera, which was recorded at an initial fair value of $13.5 million and will be marked to market value on a quarterly basis using the observable market price. Now on to 2023 results.

I'd like to take a moment to reiterate some of the key accounting applications in accounting treatment of the gallery transaction.

As a result of the F D. A approval of gambling on October 26th 2023, we made a 36 million dollar milestone payment to same terror in the fourth quarter of 2023, which was capitalized on the balance sheet is an intangible asset and will be amortized on a straight line basis over it's estimated useful life of 10 and a half.

<unk>.

I would like to reinforce that based on the timing of the a gammy approval amortization expense was prorated in the fourth quarter of 2023.

Kudlow Stuff's made a strategic equity investment in center, which was recorded with an initial fair value of $13.5 million will be mark to market value on a quarterly basis, using the observable market price.

Now onto 2023 results.

Michael W. Kalb: Our total net revenue for 2023, sorry, for 2023 was $398.2 million, a 95.9% increase when compared to total net revenue of $214.2 million for 2022. Product revenue net for 2023 for Firdapps was $258.4 million, a 20.8% increase year-over-year compared to $213.9 million for 2022. Product revenue net for FICOMPA was $138.1 million for 2013.

Our total net revenue for 2023.

Sorry, 2023 was 39 $398 $2 million, 85.9% increase when compared to total net revenue of $214 $2 million for 2022.

Product revenue for 2023 preferred apps was $258.4 million, a 20.8 increase per cent increase year over year compared to $213.9 million for 22.

Product revenue met perfect comparable which $138.1 million for 2003.

Michael W. Kalb: As mentioned in our press release, 2024 FICOMP and Net Product Revenue will be adversely affected by the gross to net adjustment. In 2023, our gross net for FICOMPA was booked under a size arrangement with distributors and government agencies. However, starting in 2024, all such costs will be tied to arrangements between us and those distributors and government agencies. Since our costs under these arrangements are likely to be higher than the size cost, We expect to be impacted by an increase in gross to net deductions for FICOMPA, thereby causing a corresponding decrease in FICOMPA net product revenue. As Jeff mentioned, this is typical for smaller companies with smaller product portfolios. Net income before income taxes for 23 was $94.5 million, a 9.7% decrease year over year compared to $104.7 million for 22.

As mentioned in our press release Twenty-twenty forefront complement predator Avenue will be adversely affected by gross commit adjustments.

In 2023 hour gross connect perfect compost booked under size arrangements with distributors and government agencies. However, starting in 2024, all such costs are tied to arrangements between us and those distributors and government agencies.

Since our costs under these arrangements are likely to be higher than the size cost.

<unk> to be impacted by an increase in gross domestic deductions for <expletive> Harper, thereby causing a corresponding decrease in pie competent product revenue.

As Jeff mentioned this typical for smaller companies with smaller product portfolios.

Net income before income taxes for 23 was $94.5 million, a 9.7% decrease year over year compared to $104.7 million for 22.

I didn't come for 2023 was adversely impacted by the 81.5 million dollar charge for improv since R&D, resulting from the Gangrel license acquisition.

Michael W. Kalb: Net income for 2023 was adversely impacted by the $81.5 million charge for in-process R&D resulting from the GAMRI license acquisition. We reported U.S. gap net income for 2023 of $71.4 million, or 67 cents per basic share and 63 cents per diluted share, a decrease of 14% year over year compared to gap net income for 22 of $83.1 million, or 80 cents per basic and 75 cents per The decrease in net income is attributed to the one-time IGAMI-related IPR&D expense recorded during the third quarter of 2023.

We reported us GAAP net income for 2023 of $71.4 million or 67 cents per basic share and 63 cents per diluted share.

Decreased some 14% year over year compared to GAAP net income for 22 of $83.1 million or 80 cents per basic and 75 cents per diluted share.

The decrease in net income is attributed to the one time of gambling related IP R&D expense recorded during the third quarter of 23.

non-GAAP net income for twenty-three was $223.2 million or $2.10 per basic and $1.96 per diluted share, which excludes the IP R&D expense, but the income tax provision of $23.1 million amortization of intangible assets related to our acquisitions different surgery comp and again I'm ready.

Michael W. Kalb: Non-Gap Net Income for 203 was $223.2 million, or $2.10 per basic and $1.96 per diluted share, which includes the IPR and the expense, the income tax provision of $23.1 million, amortization of intangible assets related to our acquisitions of Resurgi, Ficomp, and Agamri of $32.6 million, grant-based compensation expense of $14.3 million, and depreciation expense of $316,000 from Ga This compares to non-GAAP net income for 2022 of $113.9 million, or $1.10 per basic and $1.02 per diluted share, which excludes from GAAP net income the income tax provision of $21.6 million, stock-based compensation of $7.9 million, amortization expense for surgery and tangible assets of $1.1 million, and depreciation expense of $141,000. The above represents an approximate 96% increase in non-GAAP net income year over year. Without consideration for potential M&A activity, we expect amortization expense for our acquired licenses and intangible assets to be approximately $9.3 million beginning in the first quarter of 2024 and continuing until the depletion of the intangibles related to FICOMPA in 2027. Our effective tax rate for 2023 is 24.4%.

Of $32.6 million stock based compensation expensive $14.3 million and depreciation expense of $316000 from GAAP net income.

This compares to non-GAAP net income for 2022 of $113.9 million or one dollar and 10 cents per basic and one dollar two cents per diluted share, which excludes from GAAP net income the income tax provision of $21.6 million stock based compensation of $7.9 million amortization.

Some expensive or surgery intangible assets of $1.1 million and depreciation expense of $141000. The.

The above represents an approximate 96% increase of non-GAAP net income year over year.

Without consideration for potential M&A activity, we expect amortization expense for a required licenses and intangible assets to be approximately $9.3 million beginning with the first quarter of 2024 and continuing until the depletion of the intangibles related to fight carpet in 2027.

Are effective tax rate for 2023 was 24.4%. We anticipate are effective tax rate to increase slightly for 2024 hour tax rate is affected by many factors and therefore may fluctuate quarterly.

Cause a sales where approximately $52 million 20, twenty-three compared to $34 $4 million and 22 and consisted principally of royalties as a reminder, royalties for firdapse paid for a license for that product and.

Increased by 3% once net product sales exceed $100 million in any calendar year.

Michael W. Kalb: We anticipate our effective tax rate to increase slightly in 2024. However, our tax rate is affected by many factors and therefore may fluctuate quarterly. Cost of sales was approximately $52 million in 2023 compared to $34.4 million in 22 and consisted principally of royalties. As a reminder, royalties for FirdApps paid to our licensor for that product increase by 3% once net product sales exceed $100 million in any calendar year. Research and development expenses were $93.2 million in 2023. This compares to $19.8 million in 2022.

Research and development expenses were $93.2 million in 2023. This compares to $19.8 million in 2022.

Previously mentioned the driver behind the increase in research and development expenses relates to the one time, a gammy IPR R&D expense during the third quarter of 23.

Relative to normal course of business absent another acquisition, we expect R&D cause in 2024 to try and similarly to R&D cause in 2022.

SG&A expenses for 2000, twenty-three totaled $133.7 million compared to $57.1 million and 22.

The increase in SG&A year over year is principally due to expenses related to the integration a fight champa, including commercial expenses incurred under the transaction service agreement.

Michael W. Kalb: As previously mentioned, the driver behind the increase in research and development expenses relates to the one-time-a-GAMRI IP R&D expense during the third quarter of 23. Relative to the normal course of business, absent another acquisition, we expect R&D costs in 2024 to trend similarly to R&D costs in 2022. SG&A expenses for 2023 totaled $133.7 million compared to $57.1 million in 2022.

And an increase in the head count principally in sales and marketing as well as certain increases in corporate head count required to support the company's growth.

During the fourth quarter of 23, the company incurred significant selling and marketing expenses for the preparation of the gambling launch with regard to the first quarter of 2024, we anticipate a significant increase in 2024 SG&A expenses compared to Q1 of 2023 cause of the upcoming a gammy launched and the accompanying support.

Three commercial products compared to two and Q1 23.

Michael W. Kalb: The increase in SG&A year over year is principally due to expenses related to the integration of FICOMPA, including commercial expenses incurred under the Transaction Service Agreement, and an increase in headcount principally in sales and marketing as well as certain increases in corporate headcount required to support the company's growth. During the fourth quarter of 2023, the company incurred significant selling and marketing expenses for the preparation of the EGAMRI launch. With regard to the first quarter of 2024, we anticipate a significant increase in 2024 SG&A expenses compared to Q1 of 2023 due to the upcoming EGAMRI launch and the accompanying support of three commercial products compared to two in Q1'23. Additionally, I would like to note that consistent with prior years, as a result of U.S. GAAP requirements, the company expects an increase in SG&A expense in the As reported, we ended 2023 with cash and cash equivalents of $137.6 million compared to $298.4 million at December 31st, 22. The decrease in cash of $160.8 million was largely driven by approximately $293.3 million in payments in connection with acquisitions, including equity securities, which was offset by net positive cash flows generated from operations of $141.4 million.

Further I would like to note that consistent with prior years as a result of U S gap requirements. The company expects an increase in SG&A expense in the first quarter of 2024 as compared to other quarters due to its 501 C. Three donations.

As reported we ended 2023 with cash and cash equivalents of $137.6 million compared to $298.4 million at December 31, 22.

The decrease in cash of $160.8 million was largely driven by approximately nine $293.3 million in payments in connection with acquisitions, including equity Securities, which was offset by met positive cash flow was generated from operations of $141.4 million unrelated note I would like to mention that.

On January 9th 2024.

The company issued 10 million shares of common stock for total net cash proceeds of approximately $140.1 million.

Intended to fund the potential acquisition of new product candidates as well as for general corporate purposes.

We believe our current funds continue to allow us a financial flexibility to fund our existing R&D programs made out potential contractual obligations as part of our strategic initiatives business development and portfolio of sponge expansion efforts, leading to longterm growth and value creation.

More detailed information analysis of Fourthquarter and for your 2023 financial performance May be found in our annual report on Form 10-K, which was filed with the Securities and Exchange Commission yesterday February 28th and can be found on the Investor Relations page of our website at www Dot catalyst pharma dot com.

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

Michael W. Kalb: On a related note, I would like to mention that on January 9th, 2024, the company issued 10 million shares of common stock for total net cash proceeds of approximately $140.1 million, which was intended to fund the potential acquisition of new product candidates, as well as for general corporate purposes. We believe our current funds continue to allow us the financial flexibility to fund our existing R&D programs, meet our potential contractual obligations, and support our strategic initiatives, business development, and portfolio expansion efforts, leading to long-term growth and value creation. More detailed information and analysis of fourth quarter and full year 2023 financial performance may be found in our annual report on Form 10-K, which was filed with the Securities and Exchange Commission yesterday, February 28th, and can be found on the Investor Relations page of our website at www.catalystpharma.com. And with that, I'll turn the call back over to Rich.

I would like to thank the leadership team in all of our employees a catalyst for the effort they put forth to deliver such outstanding results in 2023.

We're off to a strong start in 24 with continued momentum to sustain a longterm durable growth.

We continue to be committed to excellent execution.

We are focused on increasing the scope and scale of our business through our disciplined approach and identifying derisked innovative therapies that address critical unmet medical needs and the rare orphan euro and adjacent rare orphan therapeutic areas.

We also hope to increase our geographic footprint through X U S partnerships.

In short we are prepared to investment opportunities that add value catalysts further grow a portfolio and provide improved care for patients.

Our team [noise] excuse me our team is dedicated to improving the lives of more patients by working on key lifecycle management projects that have the potential to expand the use of the products we offer.

We believe our financial rigour strength of our financial results and our cash flow physician us.

To advance are critical initiatives.

In summary, we are focused on our strategic priorities for 2024.

Number one continued to deliver double digit growth for our portfolio number to successfully launch and commercialize at gambling.

Richard John Daly: Thanks, Mike. I'd like to thank the leadership team and all our employees at Catalyst for the effort they put forth to deliver such outstanding results in 2023. We're off to a strong start in 2024 with continued momentum to sustain our long-term, durable growth. We continue to be committed to excellent execution. We are focused on increasing the scope and scale of our business through our disciplined approach to identifying de-risked, innovative therapies that address critical unmet medical needs in the rare orphan, neuro, and adjacent rare orphan therapeutic areas. We also hope to increase our geographic footprint through ex-U.S. partnerships.

Number three expansion of our product portfolio and our geographic partnerships in the CNS orphan and orphaned adjacent therapeutic spaces and.

And we look forward to providing you with updates on our progress.

At this time I will turn it back turn the call back over to our operator Kevin.

Kenneth.

Thank you and that will be conducting a question and answer session.

That can be placed into question Q. Please press star one on your telephone keypad as a reminder, we ask you. Please ask one question. One follow up then returned to the queue and then star one.

Question Q. Our first question is coming from Charles Duncan from Cantor Fitzgerald. Your line is now bye.

Yeah, good morning, rich and team congratulations on a transformative year and I appreciate the guidance going forward.

Richard John Daly: In short, we are prepared to invest in opportunities that add value to Catalysts, further grow our portfolio, and provide improved care for patients. Our team is, excuse me, our team is dedicated to improving the lives of more patients by working on key lifecycle management projects that have the potential to expand the use of the products we offer. We believe our financial rigor, the strength of our financial results, and our cash flow position us to advance our critical initiatives. In summary, we are focused on our strategic priorities for 2024. Number one, continue to deliver double-digit growth for our portfolio. Number two, successfully launch and commercialize at GAMRI. 3.

Had a quick question Firdapse with regard to that label expansion, Steve did a great job, helping us understand.

The percentage of patients really that are looking for a higher dose, but I'm wondering what is the driver of that we would there be anticipated.

Short term efficacy are long term durability.

Charles we believe that it will be long term durability, there's really two driving forces behind the.

The first is disease progression as these patients age and so big Raspberry gradually made a higher dose. The other thing also is that there are a handful of SaaS metabolized yours out there who have higher rates that also would be the higher dose and so we'll be able to support those patients.

When the F. D. A approved this 100 milligram maximum daily dose.

Operator: Expansion of our Product Portfolio and our Geographic Partnerships in the CNS Orphan and Orphan Adjacent Therapeutic Spaces, and we look forward to providing you with updates on our progress. At this time, we'll turn the call back over to our operator, Kevin.

Got it and then with jumping over to a camry one quick question for Jeff or others on the team I guess I'm wondering if you could provide a little bit more color on the registry I think you mentioned that you would be Saturday night and.

Operator: Thank you. We will now be conducting a question and answer session. If you would like to be placed in the question queue, please press star 1 on your telephone. As a reminder, we ask you please ask one question, one follow-up, then return. And that's Star Wars.

Hated size and timing any updates from that that you anticipate that could drive awareness of tomorrow loans value proposition versus other standard of care. Thanks.

[noise] Charles.

The registering the size is going to depend on how many patients.

Charles Cliff Duncan: Our first question is coming from Charles Duncan. Sheryl, your line is now live. Hey, good morning, Rich and team.

Agreed to join the registry. It is voluntary we anticipate that a significant number of patients will join the registry N b track for as long as they.

Charles Cliff Duncan: Congratulations on a transformative year and appreciate the guidance going forward. Had a quick question on PURDAPS with regard to that label expansion. Steve did a great job helping us understand, you know, the percentage of patients really that are looking for a higher dose. But I'm wondering, what is the driver of that?

And the patient registry.

In terms of duration that will be carried on for many years as we collect data for long term safety evaluation of the gallery, Gary do you want to make any commentary about the number of sites excuse me a number of sites as well.

So we will.

Looking at all of the sites that potentially enroll in commercial or to have commercial again, Murray patients and evaluate them for their ability to collect data rigorously in the registry. So at the present time, we haven't set.

Steven Miller: Would there be anticipated, you know, short-term efficacy or long-term durability? Charles, we believe that it will be long-term durability. There are really two driving forces behind this.

Steven Miller: The first is disease progression as these patients age, and so they gradually need a higher dose. The other thing also is that there are a handful of fast metabolizers out there who have higher weights that also need a higher dose. Those patients will be if and when the FDA approves this 100 mg maximum daily dose. Got it. And then, jumping over to GAMRI, one quick question for Jeff or others on the team. I guess I'm wondering if you could provide a little bit more color on the registry.

A specific number but will again <unk> said look at how many patients are prescribed oh, let the locations are in order to determine site in patient numbers.

But you would say just a sense of it's a pretty broad that we're looking at a pretty broad based approach that would that be safe to say.

Yes.

Right Okay. So.

I'll follow as helpful as.

I'm Claire Charles.

Got it. Thanks, thanks, so much for the Yankees.

Thank you next question is coming from.

Steven Miller: I think you mentioned that you would be starting that and anticipated its size and timing. Any updates from that that you anticipate that could drive awareness of the More Loans value proposition versus other standards of care? Thank you. Charles, the registry's size is going to depend on how many patients agree to join the registry. It is voluntary.

Security of your line is my life.

Alright forgotten on another strong quarter and thanks for taking my questions.

I'm really impressed that you are able to provide guidance on at a marine which has yet to launch I can only imagine that you must be getting a lot of inbound interest to be able to provide guidance.

Is this why do you think just 10 additional sales force will be sufficient to launch into a 10000, plus the empty kitchen space and.

Gary Ingenito: We anticipate that a significant number of patients will join the registry and be tracked for as long as, In terms of duration, it will be carried on for many years as we collect data for long-term safety evaluation. Gary, do you want to make any commentary about the number of sites, sorry, the number of sites as well? So we will be looking at all of the sites that potentially enroll and commercial or have commercial agamery patients and evaluate them for their ability to collect data rigorously in the registry. So at the present time, we haven't set a specific number, but we'll again, as Steve said, look at how many patients are prescribed and where the locations are in order to determine site and patient numbers.

But it'd be more word of mouth awareness or do you have any D. T cfr's in mind and have a quick follow up.

Sure. So thanks for the question June we with D. M. D. It's a very defined market. There are owning primarily 250 prescribers that prescribe 95 per cent of the corticosteroids for voice living with the M D.

Those 250 prescribers are housed in about 92 100 centers of excellence. So it's a focus call point that our team has the capacity that team that was selling firdapse had the capacity to handle and handle effectively.

Gary Ingenito: But you'd say, just the sense of, it's a pretty broad, we're looking at a pretty broad-based approach, so would that be safe to say? Yes. Right. So we'll follow up as... Clear, Charles. Got it.

Charles Cliff Duncan: Thanks. Thanks, Rich, for the attitude. The next question is coming from... I'm Patrick Miller.

And these are very experienced and tenured people. So we're very confident in that structure now as far as the pent up demand that you had mentioned and it sounds like as I mentioned on the call we'd been accepting pre commercial launch enrollments since December and based on those enrollments and the number of enrollments that we've.

Joon So Lee: Great. Congratulations on another strong quarter and thanks for taking the question. I'm really impressed that you're able to provide guidance on Agamri, which has, you know, yet to launch. I can only imagine that you must be getting a lot of inbound ventures to be able to provide it back. Is this why you think just 10 additional Salesforces would be sufficient to launch into a 10,000? And will it be more word of mouth awareness, or do you have any DTC efforts in mind? Sure.

<unk> and also the the other stakeholders that I've talked about their interest in going on <unk>.

We do believe we're confident and the number that we have provided so that's one thing as far as DTC, we have nonpersonal promotion, along with our sales force efforts to help.

Jeffrey Del Carmen: So thanks for the question, Joon. With DMD, it's a very defined market. There are only primarily 250 prescribers that prescribe 95% of the corticosteroids for boys living with DMD.

Provide education on <unk> as well as DMD that'll be focused on not only the physicians, but also to other stakeholders like patients and caregivers.

Jeffrey Del Carmen: Those 250 prescribers are housed in about 90 to 100 centers of excellence. So it's a focused call point that our team has the capacity, the team that was selling Firdeps, had the capacity to handle and handle effectively. And these are very experienced and tenured people, so we're very confident in that structure. Now as far as the pent-up demand that you had mentioned, and it sounds like, as I mentioned on the call, we've been accepting pre-commercial launch enrollments since December. And based on those enrollments and the number of enrollments that we've seen, and also the other stakeholders that have talked about their interest in going on a GAMRI, we do believe we're confident in the number that we provided. So that's one thing: provide education on Agamery as well as DMD that will be focused on not only physicians but also other stakeholders like patients and caregivers. Great, thanks for the color.

Great. Thanks to my color and on the continued strength that you're <unk> franchise, you mention conversion 500 original months patients that use my pen aside and the anticipated approval of the higher hundred milligram dose, but how does a small cell lung cancer patients factor into that guidance is that.

Not really in the guidance or is there more upside or help us navigate that that that component of that population. Thank you.

So June great question about that and it is factored in a small cell lung cancer <unk> opportunity is factored in into the growth potential, but we also see it as upside from there to you know like I mentioned about 80% of these small cell lung cancer lamb's patients are on for.

<unk> on diagnosed at this point so our efforts to accelerate that diagnosis of the diagnosis for these patients will increase the addressable market over time, which will help with our growth too.

Jeffrey Del Carmen: And on the continued strength of your For Depth franchise, you mentioned the conversion of 500 additional LEM space that you've identified. [inaudible] So, Joon, great question about that. And that is factored in; the small cell lung cancer LEMS opportunity is factored in into the growth potential, but we also see it as upside from there, too. You know, like I mentioned, about 80% of these small cell lung cancer LEMS patients are unfortunately undiagnosed at this point. So our efforts to accelerate that diagnosis, the diagnosis for these patients, will increase the addressable market over time, which will help with our growth. Congratulations again on the strong quarter. Thank you. Thank you very much. Your next question is coming from Joe Catanzaro on Piper Sandler. Your line is on.

Great. Congrats again on the strong quarter. Thank you.

Thank you thanks very much too.

Thank you next question is coming from <unk> from Piper Sandler Your line is that why.

Yeah, Hi, guys I appreciate you, taking my question and congrats and all the great progress there. So Steve I think you mentioned the percent of patients that around the current maximum dose of her depth, but I think you've previously said that you would expect even patient some on lower doses to be taken to higher doses I wonder if.

If that's still your expectation that's sort of factored into the Firdapse guidance for 2024, Thanks, and I have one quick follow up.

I'll I'll, let Jeff address the factored into the gardens, but with regard to your question about patience, beating on doses below 80 milligram.

Joseph Michael Catanzaro: Yeah. Hi, guys. I appreciate you taking the time to answer my question. Congratulations.

Yes, there are patients on that the neural <unk>.

Steven Miller: [inaudible] Thanks, and I have one quick follow-up. I'll let Jeff address the factors that went into the guidance, but with regard to your question about patients being on doses below 80 milligrams, yes, there are patients on that. The neuromuscular physician community is somewhat conservative. It's a go slow, start low, and go slow mentality.

Neural muscular physician community is somewhat conservative it's <unk> start low and go slow mentality with regard to your medical history.

Many of them like to revoke wholesome headspace in terms of the dose that patients are receiving so that if the patient gets worse. They can increase the dose with the increase in the daily maximum dosage, we would expect some of those conservative physicians, who have been concerned about the overall efficacy of 16.

Steven Miller: Many of them like to leave what I'll call some head room in terms of the dose that patients are receiving so that if the patient gets worse, they can increase the dose. With the increase in the daily maximum dosage, we would expect some of those conservative physicians who have been concerned about the overall efficacy of, say, a 60 milligram dose that a patient may have been receiving may be more likely to increase the dose, knowing that they still have more room to further increase the dose for those patients. So that is, you are correct that some of those patients at below 80 milligrams may need to increase the dose. Jeff, did you want to address factored into this? Sure, Joe.

60 milligram dose that a patient had been receiving maybe more likely to increase the dose knowing that they still have more room to further increase the dose for those patients. So that that is you're correct that some of those patients below 80 milligrams my increases.

Did you want to address factored into share job before I get into that question. Just wanted to reiterate the percentages that 40 per cent of our patients are currently on 80 milligrams. Then there's an incremental three per cent of patients are on greater than 80 milligrams currently.

Over time, we do expect the average daily dose to increase and that increase the gradual increase is factored in to the forecasts, but keep in mind with the <unk> date for this June.

Jeffrey Del Carmen: Before I get into that question, I just wanted to reiterate the percentages that 40% of our patients are currently on 80 milligrams. Then there's an incremental 3% of patients that are currently on greater than 80 milligrams. Over time, we do expect the average daily dose to increase, and that increase, that gradual increase, is factored in to the forecast, but keep in mind that with the PDUFA date for this June, it's over time, so it's just the impact from June through December of this year.

It's you know over time, so it's just the the impact from June through December of this year.

Okay. That's helpful. And then maybe my follow up question on sort of future cadence.

Jeffrey Del Carmen: Okay, thanks, that's helpful. And then maybe my follow-up question: Business Development.

Business development and maybe one for you rich as we as we look back it's sort of a historical approach to business development. How are you thinking about.

Richard John Daly: Rich, as we look back at sort of the historical approach to business development, how are you thinking about potential opportunities? So, great question. So, obviously, we feel that our balance sheet is prime right now and we're really confident and Preeti and her team are continuing to look, and we have a very wide aperture. So, we consider ourselves an orphan company, obviously, in the CNS space, so that would include epilepsy as well. And we're looking at those opportunities that are not just in CNS because we believe our infrastructure is one that supports getting the patient on and keeping the patient on. It's critical.

Central opportunities are moving forward.

So great question. So obviously, we feel that our balance sheet as prime right now and we really confident and <unk> and her team are continuing to look and we have a very wide aperture. So we consider ourselves enforcing company obviously in the CNS space. So that would include epilepsy as well and we're looking at those opportunities.

That are not only just in CNS, because we believe our infrastructure is one that supports getting the patient on and keeping the patient on that's critical we see that as a foundational element of who we are as a company. We believe that infrastructure is trends is transferable to other orphans states outside of CNS metabolic cardiovascular et cetera.

Richard John Daly: We see that as a foundational element of who we are as a company. We believe that the infrastructure is transferable to other orphan states outside of CNS, metabolic, cardiovascular, etc. So, our aperture is quite wide.

So our aperture is quite wide. So we believe our opportunities are very very broad. So we continued to scan. The landscape. We have a number of opportunities that were evaluating at a very deep level and we're we're continuing there and where where I would say appropriately aggressive.

Richard John Daly: So, we believe our opportunities are very, very broad. So, we continue to scan the landscape. We have a number of opportunities that we're evaluating at a very deep level, and we're continuing there, and we're, I would say, appropriately aggressive in our search for new opportunities that we believe fit with who we are and our ability to serve the patient. Okay, great. Thanks again. Our next question is coming from Leland Gershell from Oppenheimer. Oh, yes. Good morning, everyone.

In our search for a new opportunities that we believe fit with who we are and our ability to serve the patient community.

Okay, great. Thanks, again I appreciate you taking the question.

Thank you.

The next question is coming from.

[noise] Heimer your line is in Iowa.

Yes, good morning, everyone's thanks for taking my questions and going to see the the flunk Lightning sounds camry.

I'll spell was overall just a few questions for me accident like Tampa. It looks like you know with regarding lets me have you been more flattish you're on your 24, then I think previous to the company indicated maybe set up a <unk> single digits <unk>.

Leland James Gershell: Thanks for taking my questions. And great to see the strong guidance from CAMRI, as well as overall. Just a few questions for me. Actually, it's by Compa.

<unk> just wondering.

Leland James Gershell: Looks like, you know, with your guidance, looks maybe a bit more flattish year on year and 24 than I think previously the company indicated maybe sort of a mid to high single digit growth. Just wondering if, [inaudible] Sure Leland, so Mike will take the first part and Steve will take the second part. Sure. Morning, Leland.

Any dynamics here, we should be aware and then second <unk> is there any update with respect to I P. Specifically I think that <unk>.

We have this protected until all spring of 25, and then essentials. That's that's December 26th is wondering if there's any updates on the I T that thank you.

Currently line so Michael take the first part and Steve will take the second part.

Sure.

Morning, William and Thanks for the question <unk> as we mentioned in the press release as well as on the call.

Michael W. Kalb: Thanks for the question. Regarding FICOMPA, as we mentioned in the press release, as well as on the call, our arrangements now with wholesalers and distributors and government agencies are through us, as opposed to in 2023, when they were through ASAI. And as it is common for companies of our size, smaller companies, and smaller product portfolios, those rates are going to be slightly higher. With regard to intellectual property, we have completed our, expiration date of May of 2025. However, we are still evaluating whether or not to enforce the Polymorph patents, and we hope to conclude that evaluation soon.

Our arrangements now with wholesalers and distributors and government agencies are through us as opposed to for 2023. They were through aside and as is common for companies <unk> smaller companies smaller pop product portfolios. Those those rates are are are gonna be slightly.

[noise] higher.

With regard to the intellectual property, we have completed our.

We're.

The expiration date in May of 2025 is the.

T V and.

Kind of exclusivity for that.

Sure.

For composition of matter.

However, we are still evaluating whether or not to enforce the probably more and I hope I hope to conclude that he would argue regime.

Steven Miller: I just want to make a final comment about Psycompa. One of the reasons why we like this asset a lot is for the financial opportunity. We believe that this compound has life, significant life, beyond its patent expiry. Patients with epilepsy do not like to change drugs, even post-patent expiry, so there is a great willingness for the patient to continue on their branded medication. This is a really good, smart financial play and a good play for patients. All right, thanks. That's very helpful. Then just one question on Firdevs, if I may.

And I just want to make a final comment about psi.

<unk> one of the reasons why we we liked this asset a lot is for the financial opportunity. We believe that this <unk> has life significant life beyond its patent expiry because of the stickiness of epilepsy drugs patients with epilepsy do not like to change drugs, even posts Pat next.

<unk>. So there is a great.

Willingness for the patient to continue on their branded medication.

So.

A significant opportunity for this compound hosts expiry to continue to deliver good return for the company and that was baked into our calculus. When we bought the product. So we continued to see this is a very good opportunity to serve patients.

And to build the balance sheet and again help us to build our portfolio as we go forward. So we see this is a really good smart financial play in a good place for patients as well.

Leland James Gershell: I think they mentioned about 500 remaining diagnosed but untreated patients, if I understand that correctly. Just wondering if you could point to any particular hurdles that you may face in converting those untreated but diagnosed patients onto products. Leland.

Alright. Thanks, that's very helpful than just one question on Uhm Firdapse, if I may I think a dimension of about 500 remaining diagnose but I'm treated patients if I if I got that correctly, just wondering if you need <unk>.

But you may face and converting is untreated diagnose patients symptoms for the appointment.

Jeffrey Del Carmen: 50%, about 50% of our new enrollments each month or any given quarter come from these leads, these patients that are diagnosed but have never been treated with Firdat. We use a variety of sources to continually backfill those patients. So as one patient gets converted on to Firdeps, we find new leads to backfill those patients. So we always try to maintain those 500 or so patient leads. As far as hurdles to get on, you know, a lot of times it's just a matter of these patients waiting to get in to see their physicians. You know, whether it's a three-month or six-month time frame that they're waiting to get in. That's primarily it. There are some patients within these 500 that have been on a patient lead for over a year. But most of these, the newer leads, can be converted within 30 days. That's how we see it.

So leyland.

50% about 50% of our new enrollments each month or any given quarter come from these leads these patients that are diagnosed but never had been treated with firdapse. We use a variety of sources to continually backfill those patients so as one patient get.

Converted on to third apps, we find new leads to backfill those patient. So we always try to maintain those 500 or so patient leads as far as hurdles to get on you know a lot of times. It's just it's a matter of these patients waiting to get in to see their physicians, whether it's a three month or six month time frame that.

They are waiting to get in that that's primarily it there are some patients within these 500 that have been on the R. I a patient lead for over a year, but most of these the the newer lead can be converted within 30 days, that's how we see it but again, we backfill those pay.

Richard John Daly: But again, we backfill those patients converted with new leads over time. I think, Leland, it's all part of what we would call, you know this, the patient journey. And so it's really dependent upon the physician and the patient and where they come in and how aggressive they want to be with their own therapy. And so once we identify them, we keep calling on the physician and working with the physician to expedite therapy if it's appropriate, but it really comes down to the physician. But once we identify the physician who has the patient, we can then begin to help the physician understand the disease state and then the patient journey and how Firdavs can help that.

<unk> converted with new leads over time.

Leland, it's all part of the what we would call. You know this is the patient journey and so it's really dependent upon the physician and the patient and where they come in and and how aggressive they wanna be with around therapy and so once we identify them, we keep calling on the physician and working with a physician to expedite therapy, if it's appropriate but it really comes down the physician, but once we identify the physician who has the patient we can.

Then begin to help the physician to understand the disease State and then the patient journey and how we how firdapse can help that patient.

Okay I appreciate.

Richard John Daly: I appreciate the color. Thank you. We've reached the end of our question and answer session. And, ladies and gentlemen, that does conclude today's teleconference and webcast. Thank you.

<unk>. Thank you.

Thank you.

Thank you.

Question and answer session and ladies and gentlemen that does conclude today's teleconference and webcast.

We do thank you for your participation you may have a nice day.

Thank you.