Q2 2024 Catalyst Pharmaceuticals Inc Earnings Call

August 8, 2024

Cell phone keypad. As a reminder, the conference is being recorded.

As a reminder, this conference is being recorded.

Michael Kalb: It is now my pleasure to introduce your host, Michael Kalb, CFO.

It is now my pleasure to introduce your host Michael Kalb CFO. Thank you Michael you may begin.

Michael Kalb: You may begin. Thank you.

Unknown Executive: Thank you. Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's second quarter 2024 financial results and business highlights. Richard Daly, President and CEO, will lead the call today, and Jeffrey Del Carmen, our Chief Commercial Officer, and I will also be present. Additionally, Dr. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer, will be available for the Q&A. At this time, I'll turn the call over to you.

Unknown Executive: Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's second quarter 2024 financial results and business highlights. Richard Daly, President and CEO, will lead the call today, and Jeffrey Del Carmen, our Chief Commercial Officer, and I will also be present. Additionally, Dr. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer, will be available for the Q&A.

Michael Kalb: Thank you good morning, everyone and thank you for joining our conference call to discuss catalysts second quarter 2024 financial results and business highlights.

Michael Kalb: Good morning, everyone. And thank you for joining our conference call to discuss Catalyst's second quarter 2024 financial results and business highlights. Richard Daly, President and CEO, will leave the call today, and Jeffrey Del Carmen, our Chief Commercial Officer, and I will also present.

Speaker Change: Daly, President and CEO will lead the call today, and Jeffrey del Carmen, Our Chief Commercial officer, and I will also present. Additionally, doctors Stephen Miller, our Chief operating Officer, and Chief Scientific officer will be available for the Q&A.

Michael Kalb: Additionally, Dr. Steven Miller, our Chief Operating Officer and Chief Scientific Officer, will be available for the Q&A. Before we begin, I would like to remind you that in our remarks this morning and in the Q&A session, we will make statements about expected future results, which may be forward-looking statements for purposes of federal securities laws. These statements relate to our current expectations, estimates, and projections and do not guarantee future performance. They involve risks, uncertainties, and assumptions that are difficult to predict and may not prove to be accurate. Actual results may vary from the expectations contained in our forward-looking statements.

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 future results, which may be forward looking statements for purposes of federal Securities laws.

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 laws. These statements relate to our current expectations, estimates, and projections, and do not guarantee future performance. They involve risks, uncertainties, and assumptions that are difficult to predict and may not prove to be accurate. Therefore, actual results may vary from the expectations contained in our forward-looking statements.

Speaker Change: These statements relate to our current expectations estimates and projections and do not guarantee future performance.

Speaker Change: Risks uncertainties and assumptions that are difficult to predict and may not prove 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 2023 annual report on Form 10-K filed with the.

Michael Kalb: 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 filed with the SEC.

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 2023 annual report on Form 10-K filed with the SEC on February 28, 2024, and in our second quarter 2024 quarterly report on Form 10-Q, which was filed yesterday, August 7, 2024, with the SEC. At this time, I'll turn the call over to

Speaker Change: C C.

Michael Kalb: On February 28, 2024, and in our second quarter, 2024 quarterly report on Form 10-Q, which was filed yesterday, August 7, 2024, with the SEC.

Speaker Change: 28, 2024 and in our second quarter 2024 quarterly report on Form 10-Q, which was filed yesterday August 7th 2024 with the SEC.

Richard Daly: At this time, I'll turn the call over to Rich. Thanks, Mike, and thank you all for joining today's call. Today we'll review our second quarter, 2024 corporate performance, provide an update on our regulatory and strategic growth initiatives, dive deeper into individual product performance and conclude with a comprehensive overview of our financial results. In the second quarter of 2024, we achieved outstanding results across our commercial portfolio with total revenues of $122.7 million, a 23.2% increase over quarter to 2023, underscored by a record organic revenue growth from FedEx. The successful ongoing commercialization of a GAMRI for Duchenne's muscular dystrophy and the continued solid performance of FedCompah.

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

Richard Daly: Thanks, Mike, and thank you all for joining today's call. Today, we'll review our second quarter 2024 corporate performance, provide an update on our regulatory and strategic growth initiatives, dive deeper into individual product performance, and conclude with a comprehensive overview of our financial results. In the second quarter of 2024, we achieved outstanding results across our commercial portfolio with total revenues of $122.7 million, a 23.2% increase over the second quarter of 2023, underscored by record organic revenue growth from FRDAP, successful ongoing commercialization of Agamery for Duchenne's muscular dystrophy, and the continued solid performance of Phycompa.

Rich: Thanks, Mike and thank you all for joining today's call.

Richard Daly: We are reiterating our full year 2024 net product guidance for both Firdeps and Ficompa. Agamery continues to deliver strong performance, and we are updating our Agamery Full Year 2024 Net Product Revenue Guidance from the $25 to $30 million range we provided earlier this year to $35 to $40 million. As a result of our strong performance, we are also updating our full year 2024 total revenue financial guidance. Previously, we guided to a full year total revenue range of between $455 to $475 million.

Rich: Today, We'll review our second quarter 2020 for corporate performance provide an update on our regulatory and strategic growth initiatives dive deeper into individual product performance and conclude with a comprehensive overview of our financial results.

Rich: In the second quarter of 'twenty 'twenty four we achieved outstanding results across our commercial portfolio with total revenues of $122 $7 million or 23, 2% increase over quarter two 2023 under.

Rich: I underscored by our record organic revenue growth from preferred apps.

Rich: The successful ongoing commercialization of our Gammy for Duchenne muscular dystrophy, and the continued solid performance of five compounds.

Richard Daly: We are reiterating our full year 2024 net product guidance for both FedEx and FedCompah. A GAMRI continues to deliver strong performance, and we are updating our GAMRI full year 2024 net product revenue guidance from the $25 to $30 million range we provided early this year to $35 to $40 million. As a result of our strong performance, we are also updating our full year 2024 total revenue financial guidance. Previously, we guided to a full year total revenue range of between $455 to $475 million. Due to the solid performance of both FedEx and FedCompah and the outstanding uptake of a GAMRI, we now believe that we will achieve total revenue at the end of the range.

Rich: We are reiterating our full year 2024, net product guidance for both <unk> and <unk>.

Rich: Agamic continues to deliver strong performance and we are updating our a gummy full year 'twenty 'twenty four net product revenue guidance for the $25 million to $30 million range. We provided early this year to the $35 million to $40 million.

Unknown Executive: Agamery continues to deliver strong performance, and we are updating our Agamery Full Year 2024 Net Product Revenue Guidance from the $25 to $30 million range we provided earlier this year to $35 to $40 million. As a result of our strong performance, we are also updating our full year 2024 total revenue financial guidance. Jeff will provide further details about our commercial performance during this discussion, and Mike will give a deeper dive into the financials later in this call.

Rich: As a result of our strong performance. We are also updating our full year 2024 total revenue financial guidance.

Rich: Previously, we guided to a full year total revenue range of between $455 million to $475 million.

Richard Daly: Due to the solid performance of both Firdaps and Phycompa and the outstanding uptake of Agamery, we now believe that we will achieve total revenue at the upper end of the range. Jeff will provide further details about our commercial performance during this discussion, and Mike will give a deeper dive into the financials later in this call. Now let's review our regulatory, clinical, and business development milestones. First up, regulatory. In May, we received U.S. approval for Firdap's expanded maximum daily dose of 100 milligrams for treating LEMS, up from the previous 80 milligrams.

Rich: Due to the solid performance of both <unk> and Fad copper any outstanding uptake of the Camry. We now believe that we will achieve total revenue E upper end of the range.

Richard Daly: Jeff will provide further details about our commercial performance during this discussion, and Mike will give a deeper dive into the financials later in this call.

Rich: Jeff will provide further details about our commercial performance during this discussion and Mike will give a deeper dive into the financial financials later in this call.

Richard Daly: Now let's review our regulatory, clinical, and business development milestones. First up regulatory. In May, we received U.S. approval for FURDAPS' expanded maximum daily dose of 100 milligrams of treating LEMS, up from the previous 80 milligrams. This milestone enhances treatment flexibility for healthcare professionals, aligning with our mission to address the evolving patient needs and optimize outcomes for the LEMS patient community. As awareness of this new dosing option grows among patients and physicians, we anticipate a gradual increase in FURDAPS daily dosing over the coming quarters. In parallel, we continued to actively collaborate with our partner in Japan, Daito Farma, as we await the next regulatory milestones for FURDAPS, the NDA decision from Japanese regulatory authorities, which is expected at the end of Q3 or the beginning of Q4 this year.

Speaker Change: Now, let's review, our regulatory clinical and business development milestones.

Richard Daly: This milestone enhances treatment flexibility for health care professionals, aligning with our mission to address evolving patient needs and optimize outcomes for the LIMS patient community. As awareness of this new dosing option grows among patients and physicians, we anticipate a gradual increase in Firdop's daily doses over the coming quarters. In parallel, we continue to actively collaborate with our partner in Japan, Dido Pharma, as we await the next regulatory milestones for Firdat. The NDA decision from Japanese regulatory authorities, which is expected at the end of Q3 or the beginning of Q4 this year.

Unknown Executive: First up, regulatory. In May, we received U.S. approval for Firdap's expanded maximum daily dose of 100 milligrams for treating LEMs, up from the previous 80 milligrams. As awareness of this new dosing option grows among patients and physicians, we anticipate a gradual increase in Firdapse daily doses over the coming quarters. This study, once initiated, will gather long-term patient safety and quality of life data, offering a deeper understanding of the product's potential benefit for patients. Site identification and initiation are on track. As you know, CHI already holds commercial rights for Firdaps in Canada. CHI expects to submit an application to Health Canada for regulatory approval of the GAMRI in early 2025.

Jeff: First up regulatory.

Speaker Change: In May we received U S approval for Ferd apps has expanded maximum daily dose of 100 milligrams for cheating lens up from the previous 80 milligrams. This milestone enhances treatment flexibility for health care professionals aligning.

Jeff: Aligning with our mission to address the evolving patient needs and optimize outcomes for <unk> patient community.

Jeff: As awareness of this new dosing option grows among patients and physicians, we anticipate a gradual increase in for adaption daily dosing over the coming quarters.

Jeff: In parallel we continue to actively collaborate with our partner in Japan, Dido pharma as we await the next regulatory milestones preferred apps.

Jeff: NDA decision from Japanese regulatory authorities, which is expected at the end of Q3 or the beginning of Q4 this year.

Richard Daly: In clinical, the summer study, a five-year initiative to collect long-term safety and quality of life data for a gallery continues to advance. The study, once initiated, will gather long-term patient safety and quality of life data, offering a deeper understanding of the product's potential benefit for patients. Site identification and initiation are on track. Annual analyses of patient data is planned, potentially leading to future FDA submissions for updated product labeling, furthering our commitment to enhancing patient care and providing the latest safety information.

Jeff: In clinical the summit study a five year initiative to collect long term safety and quality of life data for a gallery continues to advance.

Richard Daly: In clinical, the summit study, a five-year initiative to collect long-term safety and quality-of-life data for GammaRay continues to advance. This study, once initiated, will gather long-term patient safety and quality of life data, offering a deeper understanding of the product's potential benefit for patients. Site identification and initiation are on track. Annual analysis of patient data is planned, potentially leading to future FDA submissions for updated product labeling, furthering our commitment to enhancing patient care and providing the latest safety information.

Jeff: The study once initiated will gather long term patient safety and quality of life data offering a deeper understanding of the product's potential benefit for patients.

Jeff: Site identification and initiation are on track.

Jeff: Annual analysis of patient data is planned potentially leading to future FDA submissions for updated product labeling furthering our commitment to enhancing patient care and providing the latest safety information.

Richard Daly: Moving to business development, subsequent to the end of Q2, in July 2024, we entered into a license agreement with Kai Farma for them to commercialize a key already holds commercial rights for FURDAPS in Canada. Kai expects to submit an application to Health Canada for regulatory approval of a GAMRI in early 2025. Our growing partnership with Kai is a great example of our commitment to improving access for patients in targeted XUS markets.

Speaker Change: Moving to business development.

Richard Daly: Moving to business development, subsequent to the end of Q2, in July 2024, we entered into a license agreement with CHI Pharma for them to commercialize a Gamma rank candidate. As you know, CHI already holds commercial rights for FRT apps in Canada. CHI expects to submit an application to Health Canada for regulatory approval of a GammaRain in early 2025.

Jeff: Subsequent to the end of Q2 and July 2024, we entered into a license agreement with kite pharma for them to.

Speaker Change: Commercialized <unk> in Canada.

Speaker Change: As you know Kai already holds commercial rights for <unk> in Canada.

Speaker Change: <unk> expects to submit an application to health, Canada for regulatory approval of a gamine early 2025.

Speaker Change: Our growing partnership with Kai It's a great example of our commitment to improving access for patients in targeted ex U S markets.

Richard Daly: Our growing partnership with CHI is a great example of our commitment to improving access for patients in targeted ex-US markets. In our efforts to build our portfolio, we hear consistent feedback from potential partners. First, our strong commercial execution across a diverse portfolio makes us an excellent partner for companies looking for a U.S. partner. Second, our launch capabilities engender trust with potential partners and are an attractive selling point. Third, our strong balance sheet makes us a formidable negotiator when acquiring new assets.

Richard Daly: In our efforts to build our portfolio, we hear consistent feedback from potential partners. First, our strong commercial execution across a diverse portfolio makes us an excellent partner for companies looking for a US partner. Second, our launch capabilities engender trust with potential partners and our attractive selling point. Third, our strong balance sheet makes us a formidable negotiator in acquiring new assets. Our strategy remains focused on delivering value for stakeholders by continuing to execute our buy-and-build plan. With the ongoing commercialization of a GAMRI, we continue to prove our capabilities in identifying, integrating, and launching products that deliver value for patients, providers, and payers.

Jeff: In our efforts to build our portfolio, we hear consistent feedback from potential partners.

Unknown Executive: First, our strong commercial execution across a diverse portfolio makes us an excellent partner for companies looking for a US partner. With the ongoing commercialization of Agamery, we continue to prove our capabilities in identifying, integrating, and launching products that deliver value for patients, providers, and payers. We are confident in our ability to leverage the focused execution of our strategic initiatives while maintaining our commitment to advancing patient care. Unlocking growth potential and delivering value for stakeholders

Speaker Change: First our strong commercial execution across a diverse portfolio makes us an excellent partner for companies looking for a U S partner.

Speaker Change: Second our launch capabilities Engender trust with potential partners and are at attractive selling point.

Speaker Change: Third our strong balance sheet makes us a formidable negotiator and acquiring new assets.

Richard Daly: Our strategy remains focused on delivering value for stakeholders by continuing to execute our buy and build plan. With the ongoing commercialization of Agamery, we continue to improve our capabilities in identifying, integrating, and launching products that deliver value for patients, providers, and payers. We are confident in our ability to leverage the focused execution of our strategic initiatives while maintaining our commitment to advancing patient care.

Jeff: Our strategy remains focused on delivering value for our stakeholders by continuing to execute our buy and build plan.

Jeff: With the ongoing commercialization of the Gambia, we continue to prove our capabilities in identifying and integrating and launching products that deliver value for patients providers and payers.

Richard Daly: We are confident in our ability to leverage the focused execution of our strategic initiatives while maintaining our commitment to advancing patient care, unlocking growth potential, and delivering value for stakeholders. Underpin by our exemplary track record and dedicated team, we believe that we are a dearly positioned to drive further growth and achieve sustained success.

Jeff: We are confident in our ability to leverage the focused execution of our strategic initiatives, while maintaining our commitment to advancing patient care and <unk>.

Jeff: <unk> growth potential and delivering value for stakeholders.

Richard Daly: Underpinned by our exemplary track record and dedicated team, we believe that we are ideally positioned to drive further growth and achieve sustained success. To summarize, we remain focused on our threefold growth strategy, outstanding execution, portfolio diversification, and ex-U.S. expansion through partnership. First, let's focus on outstanding execution. Our consistent performance continues to demonstrate our commitment to improving the lives of patients we serve and delivering on the promise of growing the company.

Jeff: Underpinned by exemplary track record and dedicated team. We believe that we are ideally positioned to drive further growth and achieve sustained success.

Richard Daly: To summarize, we remain focused on our three-fold growth strategy. Outstanding execution, portfolio diversification, and XUS expansion through partnership.

Jeff: To summarize we remain focused on our three fold growth strategy outstanding execution portfolio diversification and ex U S expansion through partnerships.

Unknown Executive: To summarize, we remain focused on our threefold growth strategy, outstanding execution, portfolio diversification, and ex-U.S. expansion through partnership. First, let's focus on outstanding execution. Our consistent performance continues to demonstrate our commitment to improving the lives of patients we serve and delivering on the promise of growing the company. Second, portfolio diversification. Our expanded focus on orphan therapeutics and adjacent orphan assets has yielded increased opportunities, and our team is rigorously evaluating each for fit and value. We will continue to work for the remainder of the year to deliver on our strategy. Executing and delivering our plan, diversifying our portfolio, and expanding our ex-U.S. partnership

Richard Daly: tips. First, let's focus on outstanding execution. Our consistent performance continues to demonstrate our commitment to improving the lives of patients we served and delivering on the promise of growing the company.

Jeff: First let's focus on outstanding execution.

Jeff: Our consistent performance continues to demonstrate our commitment to improving the lives of patients we serve and delivering on the promise of growing the company.

cell phone keypad.

Unknown Executive: As a reminder, the conference is being recorded.

Michael Kalb: It is now my pleasure to introduce your host, Michael Kalb, CFO. Thank you, Michael. You may begin. Thank you. Good morning, everyone. And thank you for joining our conference call to discuss Catalyst's second quarter, 2024 financial results and business highlights. Richard Daly, President and CEO will leave the call today and Jeffrey Del Carmen, our Chief Commercial Officer and I will also present. Additionally, Dr. Steven Miller, our Chief Operating Officer and Chief Scientific Officer will be available for the Q&A.

Jeff: Second portfolio.

Richard Daly: Second, portfolio diversification. Our expanded focus in orphan therapeutics and adjacent orphan assets has yielded increased opportunities, and our team is rigorously evaluating each for fit and value. We continue in our tireless efforts to bring on new products, and we are excited about our prospects. We remain opportunistic in pursuing the right deals at the right time, and we are well positioned to leverage our strong balance sheet to capitalize on a creative or near creative opportunities.

Jeff: Diversification.

Richard Daly: Portfolio Diversification, Our expanded focus on orphan therapeutics and adjacent orphan assets has yielded increased opportunities, and our team is rigorously evaluating each for fit and value. We continue in our tireless efforts to bring on new products, and we are excited about our prospects. We remain opportunistic in pursuing the right deals at the right time, and we are well positioned to leverage our strong balance sheet to capitalize on accretive or near-

Jeff: Our expanded focus on orphan therapeutics in adjacent orphan assets has yielded increased opportunities and our team is rigorously evaluating each for fit and value.

Jeff: We continue on our tireless efforts to bring on new products and we are excited about our prospects.

Jeff: We remain opportunistic in pursuing the right deals at the right time, and we are well positioned to leverage our strong balance sheet to capitalize on accretive or near accretive opportunities.

Richard Daly: Third, targeted XUS partnerships. We are building alliances with companies that can leverage our portfolio outside the US in high-value markets to bring improved care options to patients and providers. As we add to our portfolio, we expect to build our global presence through these cost-effective partnerships. In the second quarter, we successfully navigated an increasingly dynamic business environment, delivered on our top line across the portfolio, successfully drove the commercialization of the gamma, and expanded our commercial footprint. We will continue to work for the remainder of the year to deliver on our strategy, executing and delivering our plan, diversifying our portfolio, and expanding our XUS partnerships.

Richard Daly: Third, Targeted External Partnerships. We are building alliances with companies that can leverage our portfolio outside the U.S. in high-value markets to bring improved care options to patients and providers. As we add to our portfolio, we expect to build our global presence through these cost-effective partnerships. In the second quarter, we successfully navigated an increasingly dynamic business environment, delivered on our top line across the portfolio, successfully drove the commercialization of the GAMRI, and expanded our commercial footprint.

Jeff: Third targeted ex U S partnerships.

Michael Kalb: 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 do not guarantee future performance. They involve risks, uncertainties and assumptions that are difficult to predict and may not prove to be accurate. Actual results may vary from the expectations contained in our forward looking statements.

Jeff: We are building alliances with companies that can leverage our portfolio outside the U S and high value markets to bring improved care options for patients and providers.

Jeff: As we add to our portfolio, we expect to build our global presence through these cost effective partnerships.

Jeff: In the second quarter, we successfully navigating an increasingly dynamic business environment delivered on our top line across the portfolio successfully drove the commercialization of the Gamley and expanded our commercial footprint.

Jeff: We will continue to work for the remainder of the year to deliver on our strategy.

Richard Daly: We will continue to work for the remainder of the year to deliver on our strategy, executing and delivering our plan, diversifying our portfolio, and expanding our ex-U.S. partnership. Now, I'll turn the call over to Jeff, who will provide a commercial update.

Michael Kalb: 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 10K filed with the SEC. On February 28, 2024 and in our second quarter, 2024 quarterly report on form 10Q, which was filed yesterday, August 7, 2024 with the SEC.

Jeff: Executing and delivering our plan diversifying our portfolio and expanding our ex U S partnerships.

Jeffrey Carmen: Now, I'll turn the call to Jeff, who will provide a commercial update. Thanks, Rich, and good morning, everyone. We are incredibly pleased to report the tremendous quarterly performance across our entire commercial portfolio. These results showcase our strategic focus and operational excellence that drive our commercial success. As Rich mentioned, Catalyst had an excellent Q2 driven by the combination of sustained organic growth of Ferdaps, stable revenues from Piconpa, and the strong commercial launch of a gamma.

Jeff: Now I'll turn the call to Jeff who will provide a commercial update.

Jeffrey Del Carmen: Thanks Rich, and good morning everyone. We are incredibly pleased to report the tremendous quarterly performance across our entire commercial portfolio. I will now provide a breakdown of Q2 Net Revenues by product. Q2 net sales of $77.4 million represent a 19.2% increase over the same quarter last year.

Jeffrey Del Carmen: Thanks Rich, and good morning everyone. We are incredibly pleased to report the tremendous quarterly performance across our entire commercial portfolio. These results showcase our strategic focus and operational excellence that drive our commercial success. As Rich mentioned, Catalyst had an excellent Q2, driven by the combination of sustained organic growth of FertABS. Stable revenues from FICOMPA and the strong commercial launch of Agamri. Q2 total net revenues of $122.7 million, a 23.2% growth versus the same quarter last year, positions Catalyst well to achieve the upper end of our previously provided combined 2024 total revenue guidance of between $455 million and $475 million. I will now provide a breakdown of Q2 Net Revenues by product. But first, let me start with Firdat's performance.

Jeff: Thanks, Rich and good morning, everyone. We are incredibly pleased to report that tremendous quarterly performance across our entire commercial portfolio.

Jeff: These results showcase our strategic focus and operational excellence that drive our commercial success.

Jeff: As rich mentioned catalyst had an excellent Q2, driven by the combination of sustained organic growth a third apps stable revenues from <unk> and the strong commercial launch of the gallery.

Richard Daly: At this time, I'll turn the call over to Rich. Thanks Mike, and thank you all for joining today's call.

Richard Daly: Today we'll review our second quarter, 2024 corporate performance, provide an update on our regulatory and strategic growth initiatives, die deeper into individual product performance and conclude with a comprehensive overview of our financial results. In the second quarter of 2024, we achieved outstanding results across our commercial portfolio with total revenues of $122.7 million, a 23.2% increase over quarter to 2023, underscored by a record organic revenue growth from FedEx. The successful ongoing commercialization of a GAMRI for Duchenne's muscular dystrophy and the continued solid performance of FedCompah.

Jeffrey Carmen: Q2, total net revenues of 122.7 million, a 23.2 percent growth versus the same quarter last year, positions Catalyst well to achieve the upper end of our previously provided combined 2024 total revenue guidance of between 455 million to 475 million.

Speaker Change: Q2, total net revenues of $122 7 million, a 23, 2% growth versus the same quarter last year positions catalyst well to achieve the upper end of our previously provided combined 2024 total revenue guidance of between 404.

Jeff: 5 million to $475 million.

Jeffrey Carmen: I will now provide a breakdown of Q2 net revenues by product. First, let me start with Ferdap's performance. Q2 net sales of 77.4 million represent a 19.2 percent increase over the same quarter last year, a direct result of steady new patient enrollments and an annual discontinuation rate below the forecasted 20 percent and a high refill rate. Net new patients in Q2 were above our forecast and the highest quarterly total since Q1 2022. Prescription approval rates were greater than 90 percent across all payers, government or private commercial insurers. Ordering patterns and refill rates of 95 percent in Q2 were greater than historical norms of 90 percent.

Speaker Change: I will now provide a breakdown of Q2 net revenues by product first let me start with Fedex performance Q2, net sales of $77 4 million represent a 19, 2% increase over the same quarter last year a direct.

Jeffrey Del Carmen: Q2 net sales of $77.4 million represent a 19.2% increase over the same quarter last year. This is the direct result of studying new patient enrollments, an annual discontinuation rate below the forecasted 20 percent, and a high refill rate. Net new patients in Q2 were above our forecast and the highest quarterly total since Q1 2022. Prescription approval rates were greater than 90% across all payers, government or private commercial insurers, ordering patterns, and refill rates of 95% in Q2, or greater than historical norms of 90%.

Richard Daly: We are reiterating our full year 2024 net product guidance for both FedEx and FedCompah. A GAMRI continues to deliver strong performance and we are updating our GAMRI full year 2024 net product revenue guidance from the $25 to $30 million range we provided early this year to $35 to $40 million. As a result of our strong performance, we are also updating our full year 2024 total revenue financial guidance. Previously, we guided to a full year total revenue range of between $455 to $475 million. Due to the solid performance of both FedEx and FedCompah and the outstanding uptake of a GAMRI, we now believe that we will achieve total revenue at the end of the range.

Speaker Change: Salt steady new patient enrollments and annual discontinuation rate below the forecasted 20%.

Unknown Executive: As a direct result of studying new patient enrollments, an annual discontinuation rate below the forecasted 20 percent. Net new patients in Q2 were above our forecast. Prescription approval rates were greater than 90% across all payers, government or private commercial insurers. Our demonstrated strategic growth initiatives continue to drive organic growth.

Jeff: And a high refill rate.

Jeff: Net new patients in Q2 were above our forecast and the highest quarterly total since Q1 2022.

Jeff: Prescription approval rates were greater than 90% across all payers government or private commercial insurers.

Jeff: Ordering patterns and refill rates of 95% in Q2 were greater than historical norms of 90%.

Unknown Executive: Jeff will provide further details about our commercial performance during this discussion and Mike will give a deeper dive into the financials later in this call.

Jeffrey Carmen: We expect to return to 90% refill rates in Q3 and Q4, and the resulting 15% or greater growth quarter versus the same quarter in 2023.

Jeffrey Del Carmen: We expect to return to 90% refill rates in Q3 and Q4 and the resulting 15% or greater growth quarter versus the same quarter in 2023. We remain confident in achieving Firdap's full year 2024 guidance of between $295 million and $310 million.

Jeff: We expect to return to 90% refill rates in Q3, and Q4, and the resulting 15% or greater growth quarter versus the same quarter in 2023.

Richard Daly: Now let's review our regulatory, clinical, and business development milestones. First up regulatory. In May, we received U.S, approval for FURDAPS' expanded maximum daily dose of 100 milligrams of treating LEMS, up from the previous 80 milligrams. This milestone enhances treatment flexibility for healthcare professionals, aligning with our mission to address the evolving patient needs and optimize outcomes for the LEMS patient community. As awareness of this new dosing option grows among patients and physicians, we anticipate a gradual increase in FURDAPS daily dosing over the coming quarters.

Jeffrey Carmen: We remain confident in achieving FERTAP's full year 2024 guidance of between 295 million and 310 million. Our demonstrated strategic growth initiatives continue to drive organic growth. We maintain a pipeline of about 500 diagnosed LEMS patients in various stages of their diagnostic journey, not yet on FERTAP's. Half of our new patient enrollments typically come from this group, a prime reason for ability to consistently deliver 15 to 20% annual growth. Furthermore, LEMS education programs targeting health care providers and potential LEMS patients continue to yield a high level of voltage-gated calcium channel antibody testing, shortening the diagnostic journey for LEMS patients and leading to more patients being eligible for treatment with FERTAPs.

Jeff: We remain confident in achieving <unk> full year 2024 guidance of between $295 million and $310 million.

Jeff: Our demonstrated strategic growth initiatives continue to drive organic growth, we maintain a pipeline of about 500 diagnosed <unk> patients in various stages of their diagnostic journey not yet on first apps.

Jeffrey Del Carmen: Our demonstrated strategic growth initiatives continue to drive organic growth. We maintain a pipeline of about 500 diagnosed LEMS patients in various stages of their diagnostic journey, not yet on FertAZ. Half of our new patient enrollments typically come from this, a prime reason for our ability to consistently deliver 15 to 20% annual growth. Furthermore, LEMS education programs targeting healthcare providers and potential LEMS patients continue to yield a high level of voltage-gated calcium channel antibody testing, shortening the diagnostic journey for LEMS patients and leading to more patients being eligible for treatment with FertEx.

Unknown Executive: We maintain a pipeline of about 500 diagnosed LEMS patients in various stages of their diagnostic journey, not yet on FertAZ. Furthermore, LEMS education programs targeting healthcare providers and potential LEMS patients continue to yield a high level of voltage-gated calcium channel antibody testing, shortening the diagnostic journey for LEMS patients and leading to more patients being eligible for treatment with FertEx. Lastly, as we have mentioned before, more than 90% of small cell lung cancer LEMS patients are undiagnosed, resulting in a greater number of diagnoses for small cell lung cancer LEMS patients. As I mentioned last quarter, epilepsy regional account managers are enhancing FRTAPS' share of voice by conducting secondary FRTAPS calls with health care providers. Let's shift our focus to a gambler.

Jeff: Half of our new patient enrollments typically come from this group a prime reason for our ability to consistently deliver 15% to 20% annual growth.

Richard Daly: In parallel, we continued to actively collaborate with our partner in Japan, Daito Farma, as we await the next regulatory milestones for FURDAPS, the NDA decision from Japanese regulatory authorities, which is expected at the end of Q3 or the beginning of Q4 this year. In clinical, the summer study, a five-year initiative to collect long-term safety and quality of life data for a gallery continues to advance. The study, once initiated, will gather long-term patient safety and quality of life data, offering a deeper understanding of the product's potential benefit for patients. Site identification and initiation are on track. Annual analyses of patient data is planned, potentially leading to future FDA submissions for updated product labeling, furthering our commitment to enhancing patient, care and providing the latest safety information.

Jeff: Furthermore, lens education programs targeting healthcare providers and potential lens patients continue to yield a high level of voltage gated calcium channel antibody testing.

Jeff: Shortly the diagnostic journey for <unk> patients and leading to more patients being eligible for treatment with fared apps.

Jeffrey Carmen: Lastly, as we have mentioned before, more than 90% of small cell lung cancer LEMS patients are undiagnosed. Therefore, we are working with key thoracic oncology institutions to institute screening for newly diagnosed small cell lung cancer patients, resulting in a greater diagnosis of small cell lung cancer LEMS patients.

Jeff: Lastly, as we have mentioned before more than 90% of small cell lung cancer lamps patients are undiagnosed.

Jeffrey Del Carmen: Lastly, as we have mentioned before, more than 90% of small cell lung cancer LEMS patients are undiagnosed. Therefore, we are working with key thoracic oncology institutions to institute screening for newly diagnosed small cell lung cancer patients, resulting in a greater diagnosis of small cell lung cancer LEMS patients.

Jeff: Therefore, we are working with key thoracic oncology institutions since two screening for newly diagnosed small cell lung cancer patients, resulting in a greater diagnosis of small cell lung cancer lung patients.

Jeffrey Carmen: Now let me provide an update on FICAMPA. Q2 net revenues of 36.5 million further fortifies our revenue diversification. We expect continued stable net revenues in the second half of 2024, in line with the full year 2024 net revenue guidance of between 130 million and 135 million. As I mentioned last quarter, epilepsy regional account managers are enhancing FERTAPs' share of voice by conducting secondary FERTAPs calls with health care providers. This strategy leverages the 45% overlap in physician call points between FICAMPA and FERTAPs, boosting FERTAPs' visibility. We have seen early indicators that this tactic is working, as several patient Romans have been a direct result of this initiative.

Jeffrey Del Carmen: Now, let me provide an update on FICOM. Q2 net revenues of $36.5 million further reinforce our revenue diversification. We expect continued stable net revenues in the second half of 2024, in line with the full year 2024 net revenue guidance of between $130 million and $135 million. As I mentioned last quarter, epilepsy regional account managers are enhancing FRTAPS' share of voice by conducting secondary FRTAPS calls with health care providers. This strategy leverages the 45% overlap in physician call points between FICOMPA and Firdapse, boosting Firdapse's visibility. We have seen early indicators that this tactic is working, as several patient enrollments have been a direct result of this initiative. Let's shift our focus to a gambler.

Jeff: Now, let me provide an update on <unk>.

Speaker Change: Q2, net revenues of $36 5 million further fortifies our revenue diversification. We expect continued stable net revenues in the second half of 2024 in line with our full year 2024, net revenue guidance of between 100 and.

Richard Daly: Moving to business development, subsequent to the end of Q2, in July 2024, we entered into a license agreement with Kai Farma for them to commercialize a key already holds commercial rights for FURDAPS in Canada. Kai expects to submit an application to health Canada for regulatory approval of a GAMRI in early 2025. Our growing partnership with Kai is a great example of our commitment to improving access for patients in targeted XUS markets.

Jeff: $30 million and $135 million.

Speaker Change: As I mentioned last quarter epilepsy regional account managers are enhancing <unk> share of voice by conducting secondary <unk> calls with health care providers. This strategy Leverages, a 45% overlap and physician call points between by comp inferred apps boosting <unk> visibility.

Jeff: We are seeing early indicators that this tactic is working at several patient enrollment has been a direct result of this initiative.

Jeffrey Carmen: Let's shift our focus to gambling. Q2 product net revenues were 8.7 million. Thanks to our dedicated efforts leading up to the March 13, 2024, product launch, we successfully exceeded our initial launch expectations. Thus far, 46% of new enrollments are transitions from influenza, while 42% are switches from prednisone, which we believe is a positive sign for the acceptance of a gamma. In addition, approximately 80% of the top MD centers of excellence and greater than 140 health care providers have submitted at least one gamma in enrollment form. Around 89% of our current patients are reimbursed patients in average less than 30 days to approve. We expect the time to approval to decrease as payers finalize their policies over the next couple months.

Speaker Change: Let's shift our focus to a gambling.

Jeffrey Del Carmen: Q2 product net revenues were $8.7 million. Thanks to our dedicated efforts leading up to the March 13th, 2024 product launch, we successfully exceeded our initial launch expectations. Thus far, 46% of new enrollments are transitions from MFLAZA, while 42% are switches from prednisone, which we believe is a positive sign for the acceptance of a gambler. In addition, approximately 80% of the top MD centers of excellence and greater than 140 healthcare providers have submitted at least one Gamma Ray enrollment. Around 89% of our current patients are reimbursed patients and average less than 30 days to approval, we expect. The time to approval is expected to decrease as payers finalize their policies over the next couple, based on the promising demand trend and encouraging payer landscape.

Jeff: Q2 product net revenues were $8 7 million. Thanks to our dedicated efforts leading up to the March 13th 2024 product launch we successfully exceeded our initial launch expectations. Thus far 46% of new enrollments are transitions from <unk> Plaza.

Richard Daly: With the ongoing commercialization of a GAMRI, we continue to prove our capabilities in identifying, integrating, and launching products that deliver value for patients, providers, and payers. We are confident in our ability to leverage the focused execution of our strategic initiatives while maintaining our commitment to advancing patient care, unlocking growth potential, and delivering value for stakeholders. Underpin by our exemplary track record and dedicated team, we believe that we are a dearly positioned to drive further growth and achieve sustained success.

Jeff: While 42% are switches from prednisone, which we believe is a positive sign for the acceptance of a gambling.

Jeff: In addition, approximately 80% of the top DMD centers of excellence.

Jeff: And greater than 140 health care providers have submitted at least one gamergate enrollment form.

Jeff: Around 89% of our current patients are reimbursed patients and average less than 30 days to approval. We expect the time to approval to decrease as payers finalize their policies over the next couple of months.

Richard Daly: To summarize, we remain focused on our three-fold growth strategy. Outstanding execution, portfolio diversification, and XUS expansion through partnership, tips. First, let's focus on outstanding execution. Our consistent performance continues to demonstrate our commitment to improving the lives of patients we served and delivering on the promise of growing the company. Second, portfolio diversification. Our expanded focus in orphan therapeutics and adjacent orphan assets has yielded increased opportunities and our team is rigorously evaluating each for fit and value.

Unknown Executive: The time to approval is expected to decrease as payers finalize their policies over the next couple of years. We are revising our GAMRI full year 2024 guidance to between $35 million and $40 million of net product revenue. In summary, we are confident in our ability to continue the significant strides we are making with Firdat, reflecting our commitment to sustained organic growth. We continue to achieve stable net revenues with Vicompa and are surpassing our revenue projections for gamma. I want to thank the entire team at Catalyst for their unwavering commitment to patients and look forward to a successful second half of 2020.

Jeffrey Carmen: Based on the promising demand trend and encouraging payer landscape, we are revising our Agamery full year 2024 guidance to between 35 million to 40 million of net product revenue. In summary, we are confident in our ability to continue the significant strides we are making with FIRDFs, reflecting our commitment to sustained organic growth. We continue to achieve stable net revenues with FICAMPA and are surpassing our revenue projections for Agamery. Our emphasis remains on maintaining excellence in commercial execution, while strategically leveraging our capabilities to optimize our performance.

Jeff: Based on the promising demand trend and encouraging payer landscape. We are revising our <unk> full year 2024 guidance to between 35 million to $40 million of net product revenue.

Jeffrey Del Carmen: We are revising our GAMRI full year 2024 guidance to between $35 million and $40 million of net product revenue. In summary, we are confident in our ability to continue the significant strides we are making with Firdat, reflecting our commitment to sustained organic growth. We continue to achieve stable net revenues with Vicompa and are surpassing our revenue projections for gamma. Our emphasis remains on maintaining excellence in commercial execution while strategically leveraging our capabilities to optimize our performance. I want to thank the entire team at Catalyst for their unwavering commitment to patients and look forward to a successful second half of 2020.

Jeff: In summary, we are confident in our ability to continue the significant strides we are making with Fedex reflecting.

Jeff: Our commitment to sustained organic growth.

Speaker Change: We continue to achieve stable net revenues with by copper and are surpassing our revenue projections for gambling.

Richard Daly: We continue in our tireless efforts to bring on new products and we are excited about our prospects. We remain opportunistic in pursuing the right deals at the right time and we are well positioned to leverage our strong balance sheet to capitalize on a creative or near creative opportunities.

Speaker Change: Our emphasis remains on maintaining excellence in commercial execution, while strategically leveraging our capabilities to optimize our performance.

Michael Kalb: I want to thank the entire team at Catalyst for their unwavering commitment to patients and look forward to a successful second half of 2020.

Speaker Change: I want to thank the entire team at catalyst for their unwavering commitment to patients and look forward to a successful second half of 2012.

Michael Kalb: I will now turn the call back over to Matt. Thanks, Jeff. Our performance during the second quarter of 2024 has set us on pace for another strong year, driven by our solid financial performance and strong institution. With the successful launch of Agamery in mid March, along with the continued performance of FIRDFs and FICAMPA, we have established the foundation to achieve another revenue record-breaking year in 2024. As you heard from Jeff, we had an outstanding quarter in product revenue performance. In the second quarter of 2024, net income before income taxes was $55.8 million, a 15% increase compared to $48.5 million for the second quarter of 2023.

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

Unknown Executive: Thanks, Jeff. Our performance during the second quarter of 2024 has set us on pace for another strong year, driven by our solid financial performance and strong execution. With the successful launch of EGAMRI in mid-March, along with the continued performance of Firdapse and FICOMPA, we have established the foundation to achieve another revenue record-breaking year in 2024. As you heard from Jeff, we had an outstanding quarter in product revenue performance.

Unknown Executive: Thanks, Jeff. Our performance during the second quarter of 2024 has set us on pace for another strong year, driven by our solid financial performance and strong execution. With the successful launch of Agamri in mid-March, along with the continued performance of Firdapse and Ficompa, we have established the foundation to achieve another revenue record-breaking year in 2024. As you heard from Jeff, we had an outstanding quarter in product revenue performance.

Mike: Thanks, Jeff our performance during the second quarter of 2024 has set us on pace for another strong year, driven by our solid financial performance and strong execution.

Richard Daly: In the second quarter, we successfully navigated an increasingly dynamic business environment delivered on our top line across the portfolio, successfully drove the commercialization of the gamma and expanded our commercial footprint. We will continue to work for the remainder of the year to deliver on our strategy, executing and delivering our plan, diversifying our portfolio and expanding our XUS partnerships.

Mike: With the successful launch of <unk> in mid March along with the continued performance of <unk>. We have established the foundation to achieve another revenue record breaking year in 2024.

Mike: As you heard from Jeff, we had an outstanding quarter and product revenue performance.

Unknown Executive: In the second quarter of 2024, net income before income taxes was $55.8 million, a 15% increase compared to $48.5 million for the second quarter of 2023. We reported a gap net income of $40.8 million, or 33 cents per diluted share, an increase of 8% year over year compared to Q2 of 2023 of $37.8 million or 33 cents per diluted share. Coupled with our disciplined approach to cost management, this increase in net income is driven by organic growth of Firdaps and Ficompa and the addition of Agamma.

Speaker Change: In the second quarter of 2024 net income before income taxes was $55 $8 million, a 15% increase compared to $48 $5 million for the second quarter of 2023.

Jeffrey Carmen: Now, I'll turn the call to Jeff who will provide a commercial update. Thanks Rich and good morning everyone. We are incredibly pleased to report the tremendous quarterly performance across our entire commercial portfolio. These results showcase our strategic focus and operational excellence that drive our commercial success. As Rich mentioned, Catalyst had an excellent Q2 driven by the combination of sustained organic growth of Ferdaps, stable revenues from Piconpa and the strong commercial launch of a gamma.

Michael Kalb: We reported gap net income of $40.8 million or $0.33 per diluted share, an increase of 8% year over year compared to Q2 of 2023, of $37.8 million or $0.33 per diluted share. Coupled with our disciplined approach to cost management, this increase in net income was driven by organic growth of FIRDFs and FICAMPA and the addition of Agamery. Non-GAAP net income for the second quarter of 2024 was $69.6 million or 56 cents per diluted share, which excludes from GAAP net income, amortization of inter-tangible assets related to our acquisitions of FICAMPA, Agamery and reserve of $9.3 million.

Jeff: We reported GAAP net income of $48 million or 33 cents per diluted share an increase of 8% year over year compared to Q2 of 2023 of $37 $8 million or 33 cents per diluted share.

Mike: Coupled with our disciplined approach to cost management, this increase in net income is driven by organic growth of Firdaps and Ficompa and the addition of Agamery. Non-Gap Net Income for the second quarter of 2024 was $69.6 million, or 56 cents per diluted share, which excludes from Gap Net Income the amortization of intangible assets related to our acquisitions of Ficompa, Agamri, and Stock-based compensation expense of $3.3 million, the income tax provision of $10.8 million, and depreciation of $82,000.

Speaker Change: Coupled with our disciplined approach to cost management. This increase in net income was driven by organic growth of <unk> and the addition of <unk>.

Speaker Change: non-GAAP net income for the second quarter of 2024 was $69 6 million or 56 cents per diluted share, which excludes from GAAP net income amortization of entergy tangible assets related to our acquisitions of.

Unknown Executive: Non-Gap Net Income for the second quarter of 2024 was $69.6 million, or $0.56 per diluted share, which excludes from Gap Net Income the amortization of intangible assets related to our acquisitions of Ficompa, Agamri, and Reserji of $9.3 million, stock-based compensation expense of $4.4 million, the income tax provision of $15 million, and depreciation of $91,000. This compares to non-GAAP net income in the second quarter of 2023 of $60.4 million, or $0.53 per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FICOMPA and Resurgi of $8.5 million.

Jeff: <unk> and <unk> of $9 $3 million.

Michael Kalb: Stock-based compensation expense of $4.4 million, the income tax provision of $15 million, and depreciation of $91,000. This compares to non-GAAP net income in the second quarter of 2023, of $60.4 million or 53 cents per diluted share, which excludes from GAAP net income, amortization of intangible assets related to our acquisitions of FICAMPA and reserve of $8.5 million. Stock-based compensation expense of $3.3 million, the income tax provision of $10.8 million, and depreciation of $82,000. Our effective tax rate through the first half of 2024 was 24.5%, compared to 21.5% through the first half of 2023. The effective tax rate is affected by many factors, including the number of stock options exercised in any given period, and is likely to fluctuate in future periods.

Jeffrey Carmen: I will now provide a breakdown of Q2 net revenues by product. First, let me start with Ferdaps performance. Q2 net sales of 77.4 million represent a 19.2 percent increase over the same quarter last year, a direct result of steady new patient enrollments and annual discontinuation rate below the forecasted 20 percent and a high refill rate. Net new patients in Q2 were above our forecast and the highest quarterly total since Q1 2022.

Jeff: Stock based compensation expense of $4 $4 million, the income tax provision of $15 million and depreciation of $91000. This compares to non-GAAP net income in the second quarter of 2023 of $64 million or <unk> 53 cents per diluted share, which excluded from GAAP net income.

Jeff: Amortization of intangible assets related to our acquisitions of <unk> and reserves of $8 5 million stock based compensation expense of $3 3 million the income tax provision of $10 8 million and depreciation of $82000.

Unknown Executive: Stock-based compensation expense of $3.3 million, the income tax provision of $10.8 million, and depreciation of $82,000. Our effective tax rate through the first half of 2024 was 24.5% compared to 21.5% through the first half of 2023. The effective tax rate is affected by many factors, including the number of stock options exercised in any given period and is likely to fluctuate in future periods.

Mike: Our effective tax rate through the first half of 'twenty 'twenty four was 24, 5% compared to 21, 5% through the first half of 2023.

Jeffrey Carmen: Prescription approval rates were greater than 90 percent across all payers, government or private commercial insurers. Ordering patterns and refill rates of 95 percent in Q2 were greater than historical norms of 90 percent. We expect to return to 90% refill rates in Q3 and Q4 and the resulting 15% or greater growth quarter versus the same quarter in 2023. We remain confident in achieving FERTAP's full year 2024 guidance of between 295 million and 310 million.

Effective tax rate is affected by many factors, including the number of stock options exercised in any given period and is likely to fluctuate in future periods.

Mike: Cost of sales expense was approximately $15 $4 million in the second quarter of 2024 compared to $12 million in the second quarter of 2023 and consisted principally of royalties.

Michael Kalb: Cost of sales expense was approximately $15.4 million in the second quarter of 2024 compared to $12 million in the second quarter of 2023 and consisted principally of royalties. As a reminder, royalties for FERDAPs increased by 3% when net product sales exceed $100 million in any calendar year, which was surpassed during the second quarter of 2024. As a result, we expect cost of sales to trend higher as the year progresses. Additionally, a gamma-carzy royalty in the range of low double digits to mid-twenties as a percent of net revenue, depending on sales achievements within a calendar year.

Unknown Executive: Cost of sales expense was approximately $15.4 million in the second quarter of 2024, compared to $12 million in the second quarter of 2023, and consisted principally of royalties. As a reminder, royalties for Firdaps increased by 3% when net product sales exceeded $100 million in any calendar year, which was surpassed during the second quarter of 2024. As a result, we expect cost of sales to trend higher as the year progresses. Additionally, GAMRI carries a royalty in the range of low double digits to mid-twenties as a percent of net revenue, depending on sales achievements within a calendar year. Further details on our royalty obligations for GAMRI are disclosed in our Q2 2024 Form 10-Q and are expanded upon within the MD&A section.

Mike: As a reminder, royalties for Firdaps increased by 3% when net product sales exceeded $100 million in any calendar year, which was surpassed during the second quarter of 2024. As a result, we expect costs of sales to trend higher as the year progresses. SG&A expenses for the second quarter of 2024 totaled $40.7 million compared to $28.4 million in Q2 2023. This underscores our strategic and effective capital utilization, driving incremental cash flows for the company's benefit.

Jeff: As a reminder, royalties preferred apps increased by 3% when net product sales exceed $100 million in any calendar year, which would surpass during the second quarter of 2024.

Jeffrey Carmen: Our demonstrated strategic growth initiatives continue to drive organic growth. We maintain a pipeline of about 500 diagnosed LEMS patients in various stages of their diagnostic journey, not yet on FERTAP's. Half of our new patient enrollments typically come from this group, a prime reason for ability to consistently deliver 15 to 20% annual growth. Furthermore, LEMS education programs targeting health care providers and potential LEMS patients continue to yield a high level of voltage-gated calcium channel antibody testing, shortening the diagnostic journey for LEMS patients and leading to more patients being eligible for treatment with FERTAPs.

Mike: As a result, we expect cost of sales to trend higher as the year progresses.

Speaker Change: Additionally, the ameren cares the royalty in the range of low double digits to mid Twenty's as a percent of net revenue depending on sales achievements within a calendar year.

Michael Kalb: Further details on our royalty obligations for Gamary are disclosed in our Q2 2020-24 Form 10-Q and are expanded upon within the MD&A section. Research and development expenses were $3 million in the second quarter of 2024, slightly down from $4 million in the second quarter of 2023. SG&A expenses for the second quarter of 2024 totaled $40.7 million compared to $28.4 million in Q2 2023. The overall difference in SGNA expenses in the second quarter of 2024 was principally due to incremental operating expenses in support of the launch of a Gamary. As reported, we ended the second quarter of 2024 with cash and cash equivalents of $375.7 million compared to $137.6 million at December 31st, 2023.

Mike: Further details on our royalty obligations for January are disclosed in our Q2 2020 for Form 10-Q, and our expanded upon within the MD&A section.

Mike: Research and development expenses were $3 million in the second quarter of 2024 slightly down from $4 million in the second quarter of 2023.

Unknown Executive: Research and development expenses were $3 million in the second quarter of 2024, slightly down from $4 million in the second quarter of 2023. SG&A expenses for the second quarter of 2024 totaled $40.7 million compared to $28.4 million in Q2 2023. The overall difference in SG&A expenses in the second quarter of 2024 was principally due to incremental operating expenses in support of the launch of the GAMRI.

Mike: SG&A expenses for the second quarter of 2024 totaled $40 7 million compared to $28 $4 million in Q2 2023.

Jeffrey Carmen: Lastly, as we have mentioned before, more than 90% of small cell lung cancer LEMS patients are undiagnosed. Therefore, we are working with key thoracic oncology institutions to institute screening for newly diagnosed small cell lung cancer patients resulting in a greater diagnosis of small cell lung cancer LEMS patients.

Mike: The overall difference in SG&A expenses in the second quarter of 2024 was principally due to incremental operating expenses in support of the launch of the gallery.

Mike: As reported we ended the second quarter of 2024 with cash and cash equivalents of $375 7 million compared to $137 $6 million at December 31, 2023.

Unknown Executive: As reported, we ended the second quarter of 2024 with cash and cash equivalents of $375.7 million compared to $137.6 million at December 31st, 2023. The increase in cash of $238.1 million was driven in part by the January 9th, 2024 capital raise that resulted in $140.7 million in net cash proceeds. The remaining increase in cash is driven primarily by $96.1 million generated from operations of the business. I'd like to note that we generated approximately $53.2 million more in cash from operations for the first half of 2024 than we did for the first half of 2023.

Jeffrey Carmen: Now let me provide an update on FICAMPA. Q2 net revenues of 36.5 million further fortifies our revenue diversification. We expect continued stable net revenues in the second half of 2024, in line with the full year 2024 net revenue guidance of between 130 million and 135 million. As I mentioned last quarter, epilepsy regional account managers are enhancing FERTAPs' share of voice by conducting secondary FERTAPs calls with health care providers. This strategy leverages the 45% overlap in physician call points between FICAMPA and FERTAPs boosting FERTAPs' visibility. We have seen early indicators that this tactic is working as several patient Romans have been a direct result of this initiative.

Michael Kalb: The increase in cash of $238.1 million was driven in part by the January 9th, 2024, capillaries that resulted in $140.7 million in net cash proceeds. The remaining increase in cash is driven primarily by $96.1 million generated from operations of the business. I'd like to note that we generated approximately $53.2 million more in cash from operations in the first half of 2024 than we did for the first half of 2023. This underscores our strategic and effective capital utilization, driving incremental cash flows for the company's benefit.

Speaker Change: The increase in cash of $238 $1 million was driven in part by the January nine 2020 for a capital raise that resulted in $147 million and net cash proceeds.

Mike: The remaining increase in cash was driven primarily by $96 $1 million generated from operations of the business.

Mike: I would like to note that we generated approximately $53 $2 million more in cash from operations for the first half of 2024 than we did for the first half of 2023.

Unknown Executive: This underscores our strategic and effective capital utilization, driving incremental cash flows for the company's benefit. We believe our current funds continue to provide the financial flexibility to support our strategic initiatives, including business development and portfolio expansion, meet our potential contractual obligations, and sustain our commercial and R&D programs. More detailed information and analysis of our second quarter 2024 financial performance may be found in our quarterly report on Form 10-Q, which was filed with the Securities and Exchange Commission yesterday, August 7, and can be found on the Investor Relations page on our website at www.catalystpharma.com. At this time, I will turn the call back over to Rich. Rich?

Mike: This underscores our strategic and effective capital utilization driving incremental cash flows for the Companys benefit.

Michael Kalb: We believe our current funds continue to provide the financial flexibility to support our strategic initiatives, including business development and portfolio expansion, meet our potential contractual obligations, and sustain our commercial and R&D programs. More detailed information analysis of our second quarter 2024 financial performance may be found in our quarterly report on Form 10-Q, which was filed with the Securities and Exchange Commission yesterday, August 7th, and can be found on the Investor Relations page on our website at www.catalystforma.com.

Mike: We believe our current funds continue to provide the financial flexibility to support our strategic initiatives, including business development and portfolio expansion meet our potential contractual obligations and sustain our commercial and R&D programs.

Jeffrey Carmen: Let's shift our focus to a gambling. Q2 product net revenues were 8.7 million.

Mike: More detailed information analysis of our second quarter 2024 financial performance may be found in our quarterly report on Form 10-Q, which was filed with the Securities and Exchange Commission yesterday August seven and can be found on the Investor Relations page on our website at Www Dot catalyst farm.

Jeffrey Carmen: Thanks to our dedicated efforts leading up to the March 13, 2024 product launch, we successfully exceeded our initial launch expectations. Thus far, 46% of new enrollments are transitions from influenza, while 42% are switches from prednisone, which we believe is a positive sign for the acceptance of a gamma. In addition, approximately 80% of the top MD centers of excellence and greater than 140 health care providers have submitted at least one gamma in enrollment form. Around 89% of our current patients are reimbursed patients in average less than 30 days to approve We expect the time to approval to decrease as payers finalize their policies over the next couple months.

Mike: Dot com at this time I will turn.

Richard Daly: At this time, I will turn the call back over to Rich. Rich? Thanks, Mike. The momentum in our portfolio is exciting. Ferdatz continues to grow as predicted due to the incredible focus of our field team. Again, we're off to a great launch to this strong partnership between our medical, commercial, and patient advocacy teams. And Phycoma continues to deliver in the highly competitive market because of the relentless focus of our epilepsy team. We had a robust up to this year, and we look forward to a strong second half in 2024.

Speaker Change: Turn the call back over to rich rich.

Unknown Executive: Thanks, Mike. The momentum in our portfolio is exciting. FertApps continues to grow as predicted due to the incredible focus of our field team. AGAMRI is off to a great launch due to the strong partnership between our medical, commercial, and patient advocacy teams. We are confident in our ability to capitalize on the opportunities ahead, and our unwavering commitment to advancing patient care, unlocking growth potential, and delivering value to our stakeholders remains at the forefront of our effort.

Richard Daly: Thanks, Mike. The momentum in our portfolio is exciting. Firdapps continues to grow as predicted due to the incredible focus of our field team. AGAMI is off to a great launch due to the strong partnership between our medical, commercial, and patient advocacy teams, and Phi Kappa continues to deliver in the highly competitive market because of the relentless focus of our epilepsy team.

Speaker Change: Thanks, Mike good momentum in our portfolio is exciting for <unk> continues to grow as predicted due to the incredible focus of our field teams.

Unknown Executive: <unk> is off to a great launch due to the strong partnership between our medical commercial and patient advocacy teams.

Unknown Executive: <unk> continues to deliver in the highly competitive market because of the relentless focus of our epilepsy team.

Unknown Executive: We had a robust start to this year and we look forward to a strong second half of 2024.

Richard Daly: We had a robust start to this year, and we look forward to a strong second half in 2024. We are confident in our ability to capitalize on the opportunities ahead, and our unwavering commitment to advancing patient care, unlocking growth potential, and delivering value to our stakeholders remains at the forefront of our effort. Supported by our exemplary track record and our dedicated team, we are ideally positioned to drive further growth and achieve sustained success.

Unknown Executive: We are confident in our ability to capitalize on the opportunities ahead.

Jeffrey Carmen: Based on the promising demand trend and encouraging payer landscape, we are revising our agamery full year 2024 guidance to between 35 million to 40 million of net product revenue.

Unknown Executive: Our unwavering commitment to advancing patient care unlocking growth potential and delivering value to our stakeholders remains at the forefront of our efforts.

Richard Daly: We look forward to our stakeholders remain to the forefront of our efforts. Supported by our exemplary track record and our dedicated team, we are ideally positioned to drive further growth and achieve sustained success.

Unknown Executive: Supported by our exemplary track record and our dedicated team, we are ideally positioned to drive further growth and achieve sustained success. At Catalyst, our mission is resolute: to pioneer innovative medicines for patients with rare orphan diseases. We look forward to providing updates on our progress, and we thank our Catalyst team for their commitment and all of you for your continued support. I now turn the call back over to our operator. We look forward to answering your questions. Thank you.

Unknown Executive: Supported by our exemplary track record and our dedicated team we are ideally positioned to drive further growth and achieve sustained success.

Jeffrey Carmen: In summary, we are confident in our ability to continue the significant strides we are making with FIRDFs, reflecting our commitment to sustained organic growth. We continue to achieve stable net revenues with FICAMPA and are surpassing our revenue projections for agamery. Our emphasis remains on maintaining excellence in commercial execution, while strategically leveraging our capabilities to optimize our performance.

Richard Daly: At Catalyst, our mission is resolute, to pioneer innovative medicines for patients with rare orphan diseases. We look forward to providing updates on our progress, and we thank our Catalyst team for their commitment and all of you for your continued support. We now turn the call back over to our operator. We look forward to answering your questions. Thank you.

Richard Daly: At Catalyst, our mission is resolute to pioneer innovative medicines for patients with rare orphan diseases. We look forward to providing updates on our progress, and we thank our Catalyst team for their commitment and all of you for your continued support.

Unknown Executive: At catalyst our mission is resolute.

Unknown Executive: To pioneer innovative medicines for patients with rare orphan diseases.

Unknown Executive: We look forward to providing updates on our progress and we think our catalyst team for their commitment and all of you for your continued support.

Unknown Executive: We now turn the call back over to our operator. We look forward to answering your questions. Thank you.

Unknown Executive: We now turn the call back over to our operator, we look forward to answer your questions. Thank you.

Unknown Executive: Okay.

Operator: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question key. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

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

Unknown Executive: We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions.

Michael Kalb: I want to thank the entire team at Catalyst for their unwavering commitment to patients and look forward to a successful second half of 2020. I will now turn the call back over to Matt.

Operator: You May press star two if you'd like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.

Michael Kalb: Thanks, Jeff. Our performance during the second quarter of 2024 has set us on pace for another strong year, driven by our solid financial performance and strong institution. With the successful launch of agamery in mid March, along with the continued performance of FIRDFs and FICAMPA, we have established the foundation to achieve another revenue record breaking year in 2024.

Operator: One moment, please, while we poll for questions. Thank you. Our first question is from Charles Duncan with Cantor Fitzgerald. Please proceed with your question.

Charles Duncan: Thank you. Our first question is from Charles Duncan with Cantor Fitzgerald. Please proceed with your question. Hey, good morning, Rick, Jeff, and team. Congratulations on a really nice 2Q. And thanks for taking our questions.

Operator: Thank you. Our first question is from Charles Duncan with Cantor Fitzgerald. Please proceed with your question.

Charles Duncan: Hey, good morning, Rick, Jeff, and team. Congratulations on a really nice 2Q. And thanks for taking our questions. I had a couple. First of all, on GAMRI, do you believe that there was any bolus in the first quarter of sales because patients or caregivers were waiting for the drug to be approved and launched? And then, secondarily, I know you don't have any experience with this yet in this market, but what would you anticipate for summer in terms of, you know, patient and prescriber attention?

Charles Duncan: Hey, good morning, Rick Jeff and team congratulations on a really nice Q.

Charles Duncan: And thanks for taking our questions I had a couple first of all on a camry.

Michael Kalb: As you heard from Jeff, we had an outstanding quarter in product revenue performance. In the second quarter of 2024, net income before income taxes was $55.8 million, a 15% increase compared to $48.5 million for the second quarter of 2023. We reported gap net income of $40.8 million or $0.33 per diluted share, an increase of 8% year over year compared to Q2 of 2023, of $0.37.8 million or $0.33 per diluted share. Coupled with our disciplined approach to cost management, this increase in net income was driven by organic growth of FIRDFs and FICAMPA and the addition of agamery.

Charles Duncan: I had a couple first of all on a gallery.

Richard Daly: Do you believe that there was any boldness in the first quarter of sales because patients or caregivers were waiting for the drug to be approved and launched? And then secondarily, I know you don't have any experience with this yet in this market. But what would you anticipate for summer in terms of, you know, patient and prescriber attendance, if you will? Charles, thanks for the question. This is something we've thought a lot about, especially as we queued up the patients in beginning in December of last year.

Charles Duncan: Do you do you believe that there was any bolus in the first quarter of sales because patients or caregivers, we're waiting for the drug to be to be approved and launched.

Charles Duncan: And then secondarily I know you don't have any experience with this yet in this market, but what would you anticipate for summer in terms of.

Speaker Change: Uh huh.

Speaker Change: <unk> and prescriber attendance, if you will.

Richard Daly: Charles, thanks for the question. This is something we thought a lot about, especially as we queued up the patients at the beginning of December of last year. I'm going to turn it to Jeff. Jeff, he will give you the answer. Thanks.

Speaker Change: Charles Thanks for the question.

Speaker Change: It's something we've thought a lot about it, especially as we queued up the patients.

Jeff: Beginning in December of last year, I'm going to turn it to Jeff Jeff It will give you the answer thanks.

Jeffrey Carmen: I'm going to turn it to Jeff. Jeff, it will give you the answer. Thanks. Hi, Charles. And thanks for your question. There was significant pent-up demand leading up to the commercial launch that we had in March. So yes, to answer your first question, we did see significant interest prior to that, which helped the late launch, the late part of Q1, but also it helped Q2. So again, strong pent-up demand there. We are seeing, again, significant demand and interest moving forward. What we see is a lot of the sites; I mentioned it on the call. 80% of our, the high volume centers of excellence for D&D have enrolled at least one patient.

Michael Kalb: Non-gap net income for the second quarter of 2024 was $69.6 million or 56 cents per diluted share, which excludes from gap net income, amortization of inter-tangible assets related to our acquisitions of FICAMPA, agamery and reserve of $9.3 million. Stock-based compensation expense of $4.4 million, the income tax provision of $15 million and depreciation of $91,000. This compares to non-gap net income in the second quarter of 2023, of $60.4 million or 53 cents per diluted share, which excludes from gap net income, amortization of intangible assets related to our acquisitions of FICAMPA and reserve of $8.5 million.

Speaker Change: Hi, Charles and Thanks for your question there is significant pent up demand leading up to the commercial launch that we had in March so yes to answer. Your first question, we did see significant interest prior to that which helps.

Unknown Executive: Hi Charles, and thanks for your question. There was significant pent-up demand leading up to the commercial launch that we had in March. So yes, to answer your first question, we did see significant interest prior to that, which helped the late launch, the late part of Q1, but it also helped Q2. So again, there was strong pent-up demand there. We are seeing, again, demand and interest moving forward. What we see is a lot of the sites, I mentioned it on the call, 80% of the high volume Centers of Excellence for DMD have enrolled at So, and we've seen greater than 140 healthcare providers prescribe or submit an enrollment for a GAMRI.

Jeffrey Del Carmen: Hi Charles, and thanks for your question. There was significant pent-up demand leading up to the commercial launch that we had in March. So yes, to answer your first question, we did see significant interest prior to that, which helped the late launch, the late part of Q1, but it also helped Q2. So again, there was strong pent-up demand there. We are seeing, again, demand and interest moving forward. What we see is a lot of the sites, I mentioned it on the call, 80% of the high volume Centers of Excellence for DMD have enrolled at So, and we've seen greater than 140 healthcare providers prescribe or submit an enrollment for a GAMRI.

Unknown Executive: Eight launch.

Unknown Executive: The late part of Q1, but also it helped.

Unknown Executive: Q2.

Unknown Executive: So again strong pent up demand there.

Speaker Change: We are seeing.

Unknown Executive: Say.

Unknown Executive: Again significant demand and interest moving forward, what we see is a lot of the sites I mentioned it on the call 80% of our.

Unknown Executive: The high volume centers of excellence for DND have enrolled at least on patient.

Jeffrey Carmen: So, and we've seen greater than 140 healthcare providers, prescribers have been enrollment for a gamery. Now what we expect moving forward are the increase in the depth of interest from those physicians in the centers. As we move into Q3 and Q4. So we are excited about the demand so far, and we expect that to continue.

Unknown Executive: And we've seen greater than a 140 healthcare providers prescribe our submitted enrollment for a gallery.

Michael Kalb: Stock-based compensation expense of $3.3 million, the income tax provision of $10.8 million and depreciation of $82,000. Our effective tax rate through the first half of 2024 was 24.5%, compared to 21.5% through the first half of 2023. The effective tax rate is affected by many factors including the number of stock options exercised in any given period and is likely to fluctuate in future periods. Cost of sales expense was approximately $15.4 million in the second quarter of 2024 compared to $12 million in the second quarter of 2023 and consisted principally of royalties.

Unknown Executive: Now, what we expect moving forward is an increase in the depth of interest from those physicians in the centers as we move into Q3 and Q4. So yeah, we are excited about the demand so far, and we expect that to continue. So Jeff, as far as Charles's question regarding the summer, do you see any cyclicity so far in the summer? Any downward trend or upward? We see continued strong interest, Charles, so we expect the launch trajectory to stay the same.

Jeffrey Del Carmen: Now, what we expect moving forward is an increase in the depth of interest from those physicians in the centers as we move into Q3 and Q4. So yeah, we are excited about the demand so far, and we expect that to continue. So Jeff, as far as Charles's question regarding the summer, do you see any cyclicity so far in the summer? Any downward trend or upward? We see continued strong interest, Charles, so we expect the launch trajectory to stay the same.

Speaker Change: Now what we expect moving forward.

Speaker Change: The increase in the depth of interest from those physicians in the centers as as we move into Q3 and Q4. So we are excited about the demand so far and we expect that to continue so Geoff as far as Charles's question regarding this summer do you see any any cyclicality so far.

Richard Daly: So Jeff, as far as Charles's question regarding the summer, do you see any sequestivity so far in the summer? Any downward trend or upward trend? We see continued strong interest, Charles, so we expect the launch trajectory to stay the same. And then Charles, through the first part of your question, you know, this bolus we saw, so we, I think we referred to this in the first quarter call was as a step up. So we had a, you know, very light first quarter, because we only had two weeks. We expected to have this nice step up and then we say it's a continued traditional curve.

Jeff: Part of the summer.

Speaker Change: Any any downward downward trend or upwards, we see continued strong interest Charles So we expect the launch trajectory to stay the same and then Charles through the first part of your question. This bolus. We saw so I think we've referred to this in the first quarter call was as a step up so we had a very light first quarter, because we only had two weeks.

Jeffrey Del Carmen: And then Charles, to the first part of your question, you know, this bolus we saw, so we, I think we referred to this in the first quarter call as a step up. So we had a, you know, very light first quarter because we only had two weeks. We expected to have this nice step up. And then what we see is a continued traditional curve. And that's what I think we're experiencing. Thanks.

Unknown Executive: And then Charles, in the first part of your question, you know, this bolus we saw, so we, I think we referred to this in the first quarter call as a step up. So we had a, you know, very light first quarter because we only had two weeks. We expected to have this nice step up. And then what we say is a continued traditional curve. And that's what I think we're experiencing. Thanks for the question.

Michael Kalb: As a reminder, royalties for FERDAPs increased by 3% when net product sales exceed $100 million in any calendar year which was surpassed during the second quarter of 2024. As a result, we expect cost of sales to trend higher as the year progresses. Additionally, a gamma-carzy royalty in the range of low double digits to mid-twenties as a percent of net revenue, depending on sales achievements within a calendar year. Further details on our royalty obligations for Gamary are disclosed in our Q2 2020-24 Form 10Q and are expanded upon within the MDNA section.

Unknown Executive: We expect it to have this nice step up and then what is.

Unknown Executive: A continued traditional curve and that's what I think we were experiencing.

Charles Duncan: And that's how I think we're experiencing. Thanks for the question. That's helpful.

Unknown Executive: Thanks for the question.

Damps: That's helpful. A quick question for Damps, congratulations on the approval of the new higher dose.

Charles Duncan: That's helpful. A quick question on Firdaps.

Richard Daly: That's helpful. A quick question on Firdaps.

Charles Duncan: Quick question on fur daps.

Charles Duncan: Congratulations on the approval of the new higher dose.

Unknown Executive: Congratulations on the approval of the new higher dose. I had a question about that in terms of future adoption and persistency, if you will, for patients. Will the new dose impact discontinuations, either fewer discontinuations due to increased efficacy or satisfaction, or will it perhaps..., result in more discontinuations due to less tolerability? What's your sense of how the adoption of that higher dose will go for continued use?

Charles Duncan: Congratulations on the approval of the new higher dose. I had a question about that in terms of future adoption and persistency, if you will, for patients. Will the new dose impact discontinuations, either fewer discontinuations due to increased efficacy or satisfaction, or will it perhaps..., result in more discontinuations due to less tolerability? What's your sense of how the adoption of that higher dose will go for continued use?

Richard Daly: I had a question about that in terms of the future adoption and persistency, if you will, for patients. Will the new dose impact discontinuations, either fewer discontinuations due to increased efficacy or satisfaction, or will it perhaps result in more discontinuations due to less tolerability? What's your sense of how that adoption of that higher dose will go for continued use? Good question, Charles. And what I can tell you is, again, our annual discontinuation rate is under 20%. And within that, we see the majority of the discontinuations happen within six months of prescribing or initiating therapy on Fur Daps.

Speaker Change: I had a question about that in terms of the future adoption.

Unknown Executive: And persistency, if you will for patients.

Unknown Executive: Will the new dose impact is continuations, either fewer discontinuation due to increased efficacy or satisfaction or will it perhaps.

Michael Kalb: Research and development expenses were $3 million in the second quarter of 2024 slightly down from $4 million in the second quarter of 2023. SGNA expenses for the second quarter of 2024 totaled $40.7 million compared to $28.4 million in Q2 2023. The overall difference in SGNA expenses in the second quarter of 2024 was principally due to incremental operating expenses in support of the launch of a Gamary.

Speaker Change: The result in more discontinuation due to less tolerability, what's your sense of how that adoption of that higher dose. We'll go for it for continued use.

Speaker Change: Good question, Charles and what I can tell you is.

Jeffrey Del Carmen: Good question, Charles. And what I can tell you is, again, our annual discontinuation rate is under 20%. And within that, we see the majority of discontinuations happen within six months of prescribing or initiating therapy on Firdaps. So at this time, we don't expect the discontinuation rate to change or increase because of the more flexibility in the dose going up to 100 milliliters.

Unknown Executive: Good question, Charles. And what I can tell you is, again, our annual discontinuation rate is under 20%. And within that, we see the majority of discontinuations happen within six months of prescribing or initiating therapy on Firdapse. So at this time, we don't expect the discontinuation rate to change or increase because of the more flexibility in the dose going up to 100 milliliters.

Unknown Executive: Again, our annual discontinuation rate is under 20% and within that we see the majority of the discontinuation has happened.

Michael Kalb: As reported, we ended the second quarter of 2024 with cash and cash equivalents of $375.7 million compared to $137.6 million at December 31st, 2023. The increase in cash of $238.1 million was driven in part by the January 9th, 2024 capillaries that resulted in $140.7 million in net cash proceeds. The remaining increase in cash is driven primarily by $96.1 million generated from operations of the business. I'd like to note that we generated approximately $53.2 million more in cash from operations to the first half of 2024 than we did for the first half of 2023. This underscores our strategic and effective capital utilization driving incremental cash flows for the company's benefit.

Unknown Executive: Within six months of prescribing or initiating therapy on <unk>.

Unknown Executive: At this time, we don't expect the discontinuation to change or.

Unknown Executive: The increase because of that more flexibility in the dose going up to 100 milligrams.

Speaker Change: Okay last quick question for rich bigger picture strategy thinking about.

Richard Daly: Okay, last quick question for Rich. Bigger picture strategy, thinking about some of what you have to bring to the party in terms of in-licensing. Do you have a goal for this year? And are you focused more on neuromuscular or perhaps rare epilepsy or other areas of, you know, call it neuro-innovation?

Charles Duncan: Okay, last quick question for Rich. Bigger picture strategy, thinking about some of what you have to bring to the party in terms of in-licensing. Do you have a goal for this year? And are you focused more on neuromuscular or perhaps rare epilepsy or other areas of, you know, call it neuro-innovation?

Speaker Change: Some of.

Richard Daly: What you have to bring to the party in terms of in licensing do you have a goal for yet this year.

Richard Daly: Do you have a goal for yet this year?

Richard Daly: And are you focused more on neuromuscular or perhaps rare epilepsy or other areas of, you know, call it neuroinnovation? Thanks. Great question, Charles. So our business development strategy remains the same. We're looking at orphan and differentiated orphan. We're looking at things that are accretive or nearly accretive. And we want to bring in income diversity. So we like the opportunities in neuro because we feel like we have a great footprint there, but we're not stopping. We're not just isolating ourselves to neuro because we believe that the infrastructure that we have behind the outward facing organization, the sales organization, the patient advocacy organization really supports just about any orphan condition that we would have.

Richard Daly: Are you focused more on neuro muscular or perhaps rare epilepsy or other areas of <unk>.

Richard Daly: Call It neuro innovation.

Rich: Great question, Charles So our business development strategy remains the same we're looking at orphan differentiated orphan, we're looking at things that are accretive or nearly accretive.

Richard Daly: Great question, Charles. So our business development strategy remains the same. We're looking at orphan and differentiated orphans. We're looking at things that are accretive or nearly accretive, and we want to bring in income diversity. So we like the opportunities in Nuro because we feel like we have a great footprint there, but we're not stopping. We're not just isolating ourselves from Nuro because we believe that the infrastructure that we have behind the outward-facing organization, the sales organization, the patient advocacy organization, really supports just about any orphan condition that we would have.

Michael Kalb: We believe our current funds continue to provide the financial flexibility to support our strategic initiatives, including business development and portfolio expansion, meet our potential contractual obligations, and sustain our commercial and R&D programs. More detailed information analysis of our second quarter 2024 financial performance may be found in our quarterly report on Form 10Q, which was filed with the Securities and Exchange Commission yesterday, August 7th, and can be found on the Investor Relations page on our website at www.catalystforma.com.

Richard Daly: We want to bring an income diversity. So we like the opportunities in neuro because we feel like we have a great footprint there, but we're not stopping we're not just isolating ourselves to narrow because we believe that the infrastructure that we have behind the outward facing organization the sales organization that patient advocacy organization.

Richard Daly: It really supports just about any.

Richard Daly: So we really feel like we can bring that strength to anything. So we like the Nuro space, but we really want to move within the Nuro space if the opportunity presents itself, when it does present itself, or outside. So we're looking very broadly. We want to take advantage of those opportunities that come our way.

Richard Daly: Orphan condition that we would have so we really feel like we can bring that that strength to anything. So we we like the neuro space, but we really want to move.

Richard Daly: So we really feel like we can bring that, that, that strength to anything. So we were we like the neuro space, but we really want to move within your the neuro space if the opportunity presents itself when it does present itself or outside. So we're looking very broadly. We want to take advantage of those opportunities that come our way.

Richard Daly: At this time, I will turn the call back over to Rich. Rich? Thanks, Mike.

Richard Daly: The momentum in our portfolio is exciting. Ferdatz continues to grow as predicted due to the incredible focus of our field team. Again, we're off to a great launch to this strong partnership between our medical, commercial, and patient advocacy teams. And Phycoma continues to deliver in the highly competitive market because of the relentless focus of our epilepsy team. We had a robust up to this year, and we look forward to a strong second half in 2024.

Richard Daly: Within Europe, the neurosis, if the opportunity presents itself when it does present itself or outside so we're looking very broadly we want to take advantage of those opportunities that come our way.

Charles Duncan: Thanks, Rich. Nice quarter. Thank you very much, Charles. We really appreciate your support.

Rich: Thanks, Rich nice quarter.

Unknown Executive: Thanks, Rich. A nice quarter. Thank you very much.

Richard Daly: Thanks, Rich. A nice quarter. Thank you very much.

Operator: Thank you very much, Charles. We really appreciate your support.

Unknown Executive: Thank you very much Charles we really appreciate your support.

Unknown Executive: Thank you.

Speaker Change: Thank you. Our next question is from Samantha somehow with Citibank.

Operator: Thank you. Our next question is from Samantha Semichal with Citibank. Please proceed with your question.

Samantha Semenkow: Our next question is from Samantha Semenkow with City Black Bank. Please proceed with your question. Hi, good morning, and thanks for taking the question. And we'll meet my congratulations on a really nice and strong quarter. So, while still really early in the launch for a damn rate, I wonder how you think about the patient mix. We'll evolve over the next several quarters. It seems the percentages that are coming from Enthlota and prednisone thus far are really holding steady from what you shared on the first quarter. And I'm wondering how generic Enthlota is sitting into the overall star landscape as well.

Speaker Change: Please proceed with your question.

Speaker Change: Hi, good morning, and thanks for taking my question and let me add my congratulations on a really nice and strong quarter.

Samantha Semichal: Hi, good morning, and thanks for taking the question. And let me add my congratulations on a really nice and strong quarter.

Richard Daly: We look forward to our stakeholders remain to the forefront of our efforts, supported by our exemplary track record and our dedicated team, we are ideally positioned to drive further growth and achieve sustained success.

Samantha Semichal: So while it's still really early in the launch for GammaRay, I'm wondering how you think about the patient mix will evolve over the next several quarters. It seems the percentages that are coming from Enflava and Prednisone thus far are really holding steady from what you shared in the first quarter. And I'm wondering how generic Enflava is fitting into the overall steroid landscape as well. And then I have a follow up

Unknown Executive: So while it's still really early in the launch we're damn right I am wondering how you think about the patient mix will evolve over the next several quarters it seems the.

Speaker Change: Percentages that are coming for mental health and thus far.

Speaker Change: Steady from what you shared on the first quarter and I'm wondering how generic lovaza is fitting into the overall landscape as well and then I have a follow up.

Samantha Semenkow: And then I have a follow up.

Unknown Executive: Thanks, Samantha. Those are great questions. I'll turn it right over to Jeff for that.

Jeffrey Del Carmen: Thanks, Samantha. Those are great questions. I'll turn it right over to Jeff for that.

Jeffrey Carmen: Thanks, Samantha. Those are great questions answered right over to Jeff for that. Hi, Samantha. As far as the the next moving forward, we expect it to remain the same. Like you said, it's pretty flat and similar to what we saw early on in the launch, and it's carried forward. We're very excited about that because it shows the strong interest in the adoption of a gallery across all patients that are that were on steroids, not just a specific segment. So excited about that as far as the generic entrance for influenza coming over, and we have not seen an impact so far on adoption of a gallery for those patients.

Jeff: Thanks, Samantha those are great questions I'll turn it right over to Jeff for that ice Samantha.

Unknown Executive: We now turn the call back over to our operator. We look forward to answering your questions. Thank you.

Jeff: Hi Samantha. As far as the mix going forward is concerned, we expect it to remain the same. Like you said, it's pretty flat and similar to what we saw early on in the launch, and it's carried forward. We're very excited about that because it shows the strong interest in the adoption of a GAMRI across all patients that are on steroids, not just a specific segment. So excited about that. As far as the generic entrance for inflaza coming over, and we have not seen an impact so far on adoption of a GAMRI for those patients. So it has no impact.

Jeffrey Del Carmen: Hi Samantha. As far as the mix going forward is concerned, we expect it to remain the same. Like you said, it's pretty flat and similar to what we saw early on in the launch, and it's carried forward. We're very excited about that because it shows the strong interest in the adoption of a GAMRI across all patients that are on steroids, not just a specific segment. So excited about that. As far as the generic entrance for inflaza coming over, and we have not seen an impact so far on adoption of a GAMRI for those patients. So it has no impact.

Jeff: As far as the the next moving forward, we expect it to remain the same like you said, it's it's pretty flattened and similar to what we saw early on in the launch and its carry forward.

Unknown Executive: Thank you.

Jeff: We're very excited about that because it shows the strong interest in the adoption of <unk> across all patients that are that were on steroids not just the specific segment. So excited about that as far as the generic entrants for in Plaza.

Charles Duncan: Our first question is from Charles Duncan with Cantor Fitzgerald. Please proceed with your question. Hey, good morning, Rick Jeff and team. Congratulations on a really nice 2Q. And thanks for taking our questions. I had a couple first of all on a gallery.

Jeff: And over and we have not seen an impact so far.

Samantha Semenkow: So no impact early on. Got it.

Jeff: No impact.

Jeff: Okay.

Speaker Change: Got it great and then just on <unk> I Wonder if you could share just any updates on the process or the timing.

Samantha Semenkow: Great.

Steven Miller: And then just on third apps, I wonder if you could share just any updates on the process or the timing of the ongoing third apps paragraph for litigation. And thank you.

Unknown Executive: Got it, great. And then just on Firdaps, I wonder if you could share just any updates on the process or the timing of the ongoing Firdaps Paragraph 4 litigation. And thank you. Well, Samantha, as you know, the it's

Jeffrey Del Carmen: Got it, great. And then just on Firdaps, I wonder if you could share just any updates on the process or the timing of the ongoing Firdaps Paragraph 4 litigation. And thank you. Steve, do you want to take that? Well, Samantha, as you know, it's generally bad practice to comment on ongoing litigation. But I can tell you that we are

Steve: The paragraph four litigation and thank you Steve.

Steven Miller: Steve, do you want to take that? Sure. Well, Samantha, as you know, it's generally bad practice to comment on ongoing litigation. I can tell you that we are working diligently to bring the cases to a favorable manner as possible for Catalyst. Understand.

Steven Miller: Steve, do you want to take that? Well, Samantha, as you know...

Unknown Executive: Steve you want to take that sure.

Steven Miller: I understand. Thanks so much for taking the questions.

Speaker Change: Well <unk> as you know the.

Speaker Change: Generally bad practice to comment on ongoing litigation I can tell you that we are working diligently to bring.

Jeffrey Carmen: Jeff, it will give you the answer. Thanks.

Speaker Change: Cases too.

Unknown Executive: Yes.

Speaker Change: Favorable a manner as possible for catalyst.

Unknown Executive: Okay.

Speaker Change: Understood. Thanks, so much for taking the question.

Samantha Semenkow: Thanks so much for taking the questions. Thank you.

Jeffrey Carmen: Hi, Charles. And thanks for your question. There was significant pent up demand leading up to the commercial launch that we had in March. So yes, to answer your first question, we did see significant interest prior to that, which helped the late launch, the late part of Q1, but also it helped Q2. So again, strong pent up demand there. We are seeing, again, significant demand and interest moving forward. What we see is a lot of the sites, I mentioned it on the call, 80% of our, the high volume centers of excellence for D&D have enrolled at least one patient.

Samantha: Thank you.

Unknown Executive: Yeah.

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

Jason Gerberry: Thank you. Our next question is from Jason Gerberry with Bank of America. Please proceed with your question.

Jason Gerber: Our next question is from Jason Gerber with Bank of America. Please proceed with your question. Hey, good morning. Thank you for my questions. Maybe just first on biz dev.

Jason Gerberry: Hey, good morning. Thanks for taking my questions. Maybe just first, on BizDev, are you generally inclined to do more deals funded with cash and back-end success-based milestones or talk about maybe an appetite to take on some leverage to go after some larger targets that could be more transformational?

Unknown Executive: Hey, good morning. Thanks for taking my questions. Maybe just first, on BizDev, are you generally inclined to do more deals funded with cash and back-end success-based milestones or talk about maybe an appetite to take on some leverage to go after some larger targets that could be more transformational?

Speaker Change: Hey, good morning, Thanks for taking my question maybe.

Unknown Executive: Maybe just first on Biz Dev or you generally inclined to do more deals funded with cash and backend success based milestones or talking about maybe appetite to take on some leverage to go after some larger targets that could be more transformational.

Richard Daly: Are you generally inclined to do more deals funded with cash and backend success-based milestones, or talk about maybe appetite to take on some leverage to go after some larger targets that could be more transformational. Great question, Jason. So we would be looking for opportunities to add to the income statement right now and look for that opportunity. I think we could handle a deal or two with the cash that we have. And then I think we would probably look to dip into the leverage opportunity. After that, I think we would be looking to look for more of a transformational opportunity.

Unknown Executive: Yeah.

Richard Daly: Great question, Jason. So we would be looking for opportunities to add to the income statement right now and look for that opportunity. I think we could handle a deal or two with the cash that we have, and then I think we would probably look to dip into a leveraged opportunity. After that, I think we would be looking for more of a transformational opportunity. We like the building of income diversity as a stepwise function for the company.

Speaker Change: A great question, Jason So we would be looking for opportunities to add to the income statement rates right now and look for that opportunity I think we could handle a deal or two with the cash that we have and then I think we would probably look to dip into the.

Speaker Change: Our leverage opportunity.

Speaker Change: After that I think we would be looking to.

Speaker Change: Look for more of a transformational opportunity we like the building of the income diversity.

Richard Daly: We like the building of the income diversity as a stepwise function for the company. We think that's the best path forward for us. We like our product mix at this point in time. And we want to build up that strength of the income statement and continue to build the balance sheet.

Speaker Change: As a step wise function for the company, we think that's the best path forward for us.

Richard Daly: We think that's the best path forward for us. We like our product mix at this point in time, and we want to build up that strength of the income statement and continue to build a balance sheet. And at that point, I think we are looking at more of a transformational opportunity. Mike, any comments?

Speaker Change: We like our product mix at this point in time, and we want to build up that strength of the income statement and continue to build the balance sheet.

Unknown Executive: And at that point, I think looking at more of a transformational opportunity Mike any comments.

Richard Daly: And at that point, I think looking at more of a transformational opportunity might any comments. So it sounds like maybe more of a sequencing of deals where or something that involved leverage would be after other deals that maybe improve your profitability and your cash flow base, then you consider larger transformational deals. That's the right way to think about it. I think so. Yeah, it looked when you think about what we're trying to do is build up the strength of the company. We feel like we're really in a great position right now. We feel like we're strong.

Jeffrey Carmen: Any downward trend or upward trend? We see continued strong interest, Charles, so we expect the launch trajectory to stay the same. And then Charles, through the first part of your question, you know, this bolus we saw, so we, I think we referred to this in the first quarter call was as a step up. So we had a, you know, very light first quarter, because we only had two weeks, we expected to have this nice step up and then we say it's a continued traditional curve. And that's how I think we're experiencing. Thanks for the question. That's helpful.

Unknown Executive: I think you covered it. We have a strong balance sheet. We're ready.

Speaker Change: I think you covered it well.

Unknown Executive: Balance sheet.

Unknown Executive: Yes.

Jason Gerberry: So it sounds like maybe more of a sequencing of deals, or something that involved leverage, would be after other deals that maybe improve your profitability in your cash flow base, then you consider larger transformational deals that

Speaker Change: So it sounds like maybe more of a sequencing of deals where or something that involve leverage would be after other deals that maybe improve your profitability and your cash flow base. Then you would consider larger transformational deals.

Speaker Change: The right way to think about it.

Richard Daly: I think so, yeah. When you think about what we're trying to do is build up the strength of the company. We feel like we're really in a great position right now. We feel like we're strong. We know we're strong, and then as we think about the long-term of the company, we want to work our way back into the pipeline. So as we build that future orientation of the company, we want to have that strong cashflow and a strong balance sheet to be able to take on that transformational opportunity.

Speaker Change: So yes.

Speaker Change: When you think about what we're trying to do is build up the strength of the company. We feel like we're really in a great position right. Now we feel like were strong. We know were strong and then as we think about the long term of the company we want to work our way back on the pipeline. So as we rebuild that future orientation of the company, we want to have that strong cash flow strong balance sheet.

Richard Daly: We know we're strong, and then as we think about the long term of the company, we want to work our way back in the pipeline. So as we build that future orientation of the company, we want to have that strong cash flow, strong balance to be able to take on that transformational opportunity.

Charles Duncan: Quick question on fur daps.

Richard Daly: Congratulations on the approval of the new higher dose. I had a question about that in terms of the future adoption and persistency if you will, for patients, will the new dose impact discontinuations either fewer discontinuations due to increased efficacy or satisfaction, or will it perhaps result in more discontinuations due to less tolerability? What's your sense of how that adoption of that higher dose will, go for continued use? Good question, Charles. And what I can tell you is, again, our annual discontinuation rate is under 20%. And within that, we see the majority of the discontinuations happen within six months of prescribing or initiating therapy on fur daps.

Speaker Change: To be able to take on that transformational opportunity.

Jason Gerberry: Okay, and then if I can ask a question about Firdapps, just the growth that you're seeing, it looks like maybe it's two-thirds volume, maybe a third price mix. I assume that that volume is mostly patients that don't have small cell lung as a component of their disease. So is that kind of what you're seeing in terms of the mix and what's driving this kind of 15 to 20 percent growth

Jeffrey Carmen: Okay, and then if I can ask a question about bird apps, just the growth that you're seeing, it looks like maybe it's two thirds volume, maybe a third price mix. I assume that that volume is mostly patients that don't have small cell lung as a component of their disease. So is that kind of what you're seeing in terms of the mix and what's driving this kind of 15 to 20% growth? It's pretty accurate there. We are seeing, you know, from the non-small cell lung cancer, LEMS patients, we've seen steady about a low 20% as far as our mix goes of our total LEMS patients that have small cell.

Speaker Change: Okay, and then if I can ask a question about bird apps.

Unknown Executive: The growth that Youre seeing.

Speaker Change: It looks like maybe two thirds volume and maybe a third price mix I assume that that volume is most of the patients that don't have small cell lung.

Speaker Change: As a <unk>.

Unknown Executive: component of their disease. So is that kind of what you're seeing in terms of the mix and what's driving this kind of 15 to 20% growth?

Speaker Change: Component of their disease. So is that kind of what youre seeing in terms of the mix and what's driving this kind of 15% to 20% growth.

Speaker Change: It's a pretty accurate there we are seeing from us.

Jeffrey Del Carmen: It's pretty accurate there. We are seeing, you know, from, you know, the non-small cell lung cancer LEMS patients, we've seen steady, about a low 20% as far as our mix goes of our total LEMS patients that have small cells. So, you know, we expect that it's our opportunity moving forward to help increase that share. As I mentioned on the call, about 90% of those patients, small cell lung cancer LEMS patients, are undiagnosed there or are undiagnosed at this time.

Speaker Change: On the non small cell lung cancer lung patients.

Speaker Change: We've seen steady about low 20% as far as our mix goes of arc <unk> patients.

Speaker Change: That have small cell.

Jeffrey Carmen: So, you know, we expect that it's our opportunity moving forward to help include that share. As I mentioned on the call, about 90% of those patients, small cell lung cancer LEMS patients, are undiagnosed; there are undiagnosed at this time. So we're applying a lot of resources towards helping those patients get diagnosed sooner. So that's where our growth will be coming from. But, as far as today, you're accurate about how you described the dividing up that growth. Got it. Thanks so much, guys.

Speaker Change: So we expect that as our as our opportunity moving forward to help in that share.

Richard Daly: This time, we don't expect the discontinuation to change or increase because of that more flexibility in the dose going up to 100 millivirams. Okay, last quick question for Rich, bigger picture, strategy, thinking about some of, you know, what you have to bring to the party in terms of in licensing. Do you have a goal for yet this year? And are you focused more on neuromuscular or perhaps rare epilepsy or other areas of, you know, call it neuroinnovation?

Speaker Change: As I mentioned on the call about 90% of those patients in small cell lung cancer landscape <unk> are undiagnosed there are on diagnosed at this time. So we are applying a lot of resources towards helping those patients get diagnosed sooner. So that's where our growth will be coming from that as far as today Youre accurate about how you described.

Jason Gerberry: So we're applying a lot of resources towards helping those patients get diagnosed sooner. So that's where our growth will be coming from. But as far as today, you're accurate about how you described dividing up that growth. Got it. Thanks.

Speaker Change: The dividing up that growth.

Unknown Executive: Got it. Thanks so much, guys.

Jason Gerberry: Got it. Thanks so much, guys.

Speaker Change: Got it thanks, so much guys.

Unknown Executive: Got it. Thanks.

Speaker Change: Thank you.

Jason Gerber: Thank you.

Speaker Change: Thank you. Our next question is from Joon Lee with true Securities. Please proceed with your question.

Joon Lee: Thank you. Our next question is from Joon Lee with True Securities. Please proceed with your question.

June Late: Our next question is from June late with true securities. Please proceed with your question. Good morning. This is awesome. One for June, congrats on the quarter, and thanks for taking questions. It was mentioned in the prepared remarks that refill rates were higher than historical norm for FedEx. Can you explain what led to that and why you expected to return back to 90% of the fallen quarters. And then also FedEx. How soon after approval of 100 milligrams dose, did you start some patients which should hire those and how much of an impact you think they had in the quarter.

Joon Lee: Good morning, this is Asimov with Joon, congrats on the quarter, and thanks for taking the question. It was mentioned in the prepared remarks that refill rates were higher than the historical norm for Firdaps. Can you explain what led to that and why you expect to return back to 90% in the following quarters? And then also, on Firdaps, how soon after approval of the 100 mg dose did you start seeing patients switch to the higher dose? and how much of an impact you think they'll have in the quarter. Thank you.

Unknown Executive: Good morning, this is Asimone for June. Congratulations on the quarter, and thank you for taking the question. And how much of an impact do you think they'll have in the quarter? Thank you.

Unknown Executive: Good morning, this is often lumpy Jim congrats on the quarter.

Unknown Executive: And thank you for taking my questions.

Richard Daly: Thanks. Great question, Charles. So our business development strategy remains the same. We're looking at orphan and differentiated orphan. We're looking at things that are accretive or nearly accretive. And we want to bring in income diversity. So we like the opportunities in neuro because we feel like we have a great footprint there, but we're not stopping. We're not just isolating ourselves to neuro because we believe that the infrastructure that we have behind the outward facing organization, the sales organization, the patient advocacy organization really supports just about any orphan condition that we would have.

Speaker Change: It was mentioned in the prepared remarks that we fill rates were higher than historical norms for for that can you explain what led to that in light.

Speaker Change: And back to 90%.

Unknown Executive: Fallen quarters and then.

Speaker Change: Also unfair thats how soon after approval of the 100 milligram dose did you start seeing patients switching to <unk>.

Richard Daly: So we really feel like we can bring that that that strength to anything. So we we're we like the neuro space, but we really want to move within your the neuro space if the opportunity presents itself when it does present itself or outside. So we're looking very broadly. We want to take advantage of those opportunities that come our way.

Unknown Executive: And how much of an impact you can perhaps on the quarter. Thank you.

June Late: Thank you. Thanks, June. And thanks for your support as well.

Jeff: Thanks, Joon, and thanks for your support as well. Jeff, do you want to take that? Sure. As I had mentioned in Q1.

Jeffrey Del Carmen: Thanks, Joon, and thanks for your support as well. Jeff, do you want to take that? Sure. As I had mentioned in Q1.

Unknown Executive: Thanks, Joon and thanks for your support as well and Jeff will take that.

Jeffrey Carmen: Jeff, do you want to take that? Sure. As I had mentioned on the Q1 earnings call, we saw some impact from the Change Healthcare that impacted the refill rate in February. Overall, for the quarter and Q1, we were at about 86%. And so traditionally, our historical norms are 90%. In April and May, we saw recovery there, and we saw higher than the 90% historical norm refill rate, and it actually went up to 95% because of that. So patients that were impacted by that in Q1 filled their rates, filled their prescriptions more in Q2. We expect that to normalize and return to the 90% for Q3 and Q4, instilled delivering the 15% or greater growth for FedEx.

Jeff: Sure. As I had mentioned on the Q1 earnings call, we saw some impact from the healthcare changes that impacted the refill rate in February. Overall, for the quarter in Q1, we were at about 86%. And so, traditionally, our historical norms are 90%.

Jeffrey Del Carmen: Sure. As I had mentioned on the Q1 earnings call, we saw some impact from the healthcare changes that impacted the refill rate in February. Overall, for the quarter in Q1, we were at about 86%. And so, traditionally, our historical norms are 90%.

Jeff: Sure.

Jeff: I had mentioned on the Q1 earnings call.

Jeff: We saw some impact from the change healthcare that impacted the refill rate.

Jeff: February overall for the quarter in Q1, we were at about 86% and so traditional or historical norms are 90%.

Jeff: In April and May we saw we saw a recovery there and we saw higher than the 90% historical norm refill rate and that actually went up to 95% because of that so patients that were impacted by that in Q1.

Jeff: In April and May, we saw a recovery there, and we saw higher than the 90% historical norm refill rate, and it actually went up to 95% because of that. So patients that were impacted by that in Q1 filled their prescriptions more in Q2. We expect that to normalize and return to 90% for Q3 and Q4, and still deliver 15% or greater growth for Firdat. As far as the 100 milligram expansion, you know, it's a great thing for patients and healthcare providers.

Jeffrey Del Carmen: In April and May, we saw a recovery there, and we saw higher than the 90% historical norm refill rate, and it actually went up to 95% because of that. So patients that were impacted by that in Q1 filled their prescriptions more in Q2. We expect that to normalize and return to 90% for Q3 and Q4, and still deliver 15% or greater growth for Firdat. As far as the 100 milligram expansion, you know, it's a great thing for patients and healthcare providers.

Charles Duncan: Thanks, Rich. Nice quarter. Thank you very much, Charles. We really appreciate your support. Thank you.

Jeff: Their rates fill their prescriptions more in Q2.

Samantha Semenkow: Our next question is from Samantha Semenkow with City Black Bank. Please proceed with your question. Hi, good morning, and thanks for taking the question.

Jeff: Beth that to normalize and return to the 90% for Q3, and Q4 and still delivering the 15% or greater growth preferred apps.

Samantha Semenkow: And we'll meet my congratulations on a really nice and strong quarter. So while still really early in the launch for a damn rate, I wonder how you think about the patient mix. We'll evolve over the next several quarters. It seems the percentages that are coming from Enthlota and prednisone thus far really holding steady from what you shared on the first quarter. And I'm wondering how generic Enthlota is sitting into the overall star landscape as well.

Jeffrey Carmen: As far as the 100 milligram expansion, it's a great thing for patients and healthcare providers. It really does give them the flexibility to manage and treat their LEM symptoms. Also, just a quick step back, 40% of LEM patients prior to the label expansion were on 80 milligrams. And those patients, the average daily dose went up by about a milligram, 1.1 milligram, since that label expansion. We did not expect or do not expect that bolus to just happen immediately. We expect that increase in the average daily dose to reach its full impact in the subsequent quarters.

Jeff: As far as the 100 milligram expansion.

Speaker Change: Great. It's a great thing for patients and health care providers. It really does give them the flexibility to manage and treat.

Jeff: It really does give them the flexibility to manage and treat their LEMS symptoms. For LEMS patients prior to the label expansion, the average daily dose was 80 milligrams, and those patients, the average daily dose went up by about a milligram, 1.1 milligram since that label expansion. We did not expect, or do not expect, that bolus to just happen immediately. We expect that increase in the average daily dose to reach its full impact in the subsequent quarter.

Jeffrey Del Carmen: It really does give them the flexibility to manage and treat their LEMS symptoms. And also, just a quick step back, 40% of LEMS patients prior to the label expansion were on 80 milligrams. And those patients, the average daily dose went up by about a milligram, 1.1 milligram since that label expansion. We did not expect, or do not expect, that bolus to just happen immediately. We expect that the increase in the average daily dose to reach its full impact in the subsequent quarter.

Speaker Change: They're less symptoms.

Speaker Change: Also just a quick step back 40%.

Jeff: Lens patients prior to the label expansion.

Jeffrey Carmen: And then I have a follow up. Thanks, Samantha. Those are great questions answered right over to Jeff for that. Hi, Samantha. As far as the the next moving forward, we expect it to remain the same. Like you said, it's it's pretty flatten and similar to what we saw early on in the launch and it's carried forward. We're very excited about that because it shows the strong interest in the adoption of a gallery across all patients that are that were on steroids, not just a specific segment.

Jeff: On 80 milligrams and those patients the average daily dose went up.

Jeff: By about one milligram one one milligram.

Jeff: Since that label expansion.

Jeff: We did not expect or do not expect that bolus to just happen immediately we expect that increase of the average daily dose can reach its full impact in the subsequent quarters.

Jeff: Okay.

Jeffrey Carmen: So excited about that as far as the generic entrance for influenza coming over and we have not seen an impact so far on adoption of a gallery for those patients. So no impact early on. Got it.

Speaker Change: Thank you.

Speaker Change: So I just want to clarify David Jeff made 50% growth is 15% growth over Q2 2023.

Jeffrey Carmen: So I just want to clarify, David Jeff made 50% growth is 15% growth over Q to 2023, just to clarify. So we've turned to that growth as we can do a comparison. It's, we look at Q3, 2024, the 15% growth will see us versus Q2, sorry, Q3 versus Q3, 2023.

Jeffrey Del Carmen: So I just want to clarify a statement Jeff made, 15% growth is 15% growth over Q2 2023. Just to clarify. So we've turned to that growth as we do a comparison. It's, when we look at Q3 2024, the 15% growth we'll see is versus Q3, Q2 20, oh sorry, Q3, versus Q3 2023. Thanks.

Unknown Executive: Just to clarify. So we've turned to that growth as we do a comparison. It's, we look at Q3 2024, the 15% growth we'll see is versus Q3, Q2 20, sorry, Q3, versus Q3 2023. Thanks.

Jeff: Just to clarify.

Samantha Semenkow: Great.

Unknown Executive: So we turn to that growth as we kind of do a comparison as we look at Q3, 2024% to 50% growth will cease versus Q3 Q2 Q3.

Steven Miller: And then just on third apps, I wonder if you could share just any updates on the process or the timing of the ongoing third apps paragraph for litigation. And thank you.

Unknown Executive: Versus Q3 2023.

Leland Gershell: Thanks. Thank you.

Unknown Executive: Okay.

Steven Miller: Steve, do you want to take that? Sure. Well, Samantha, as you know, the it's generally bad practice to comment on ongoing litigation. I can tell you that we are working diligently to bring the cases to a favorable manner as possible for catalyst. Understand.

Samantha Semenkow: Thanks so much for taking the questions. Thank you.

Speaker Change: Thank you. Our next question is from Leland <unk> with Oppenheimer and company. Please proceed with your question.

Leland Gershell: Thank you. Our next question is from Leland Gershell with Oppenheimer & Company. Please proceed with your question.

Leland Gershell: Now our next question is from Leland Gershield with Oppenheimer and Company. Please proceed with your question. Good morning, my congrats on the strong quarter as well. And thanks for taking the question. Just a question again on a Gamri: you know, these patients, if you stand up and are not seeing their specialists that frequently, if they're medically stable, you know, maybe once or three months, sometimes once every six months. I'm just wondering. If you've been seeing patients coming in to switch to a Gamri, be it now available, or they sort of waiting for their next visual deployment to change steroids, just sort of an observational question, if you have any perspective there.

Leland Gershell: Hi, good morning. Mike, congrats on the strong quarter as well.

Unknown Executive: Hi, good morning. Mike, congrats on the strong quarter as well.

Unknown Executive: Okay.

Unknown Executive: Morning.

Speaker Change: My congrats on the strong quarter as well and thanks for taking the question.

Unknown Executive: And thanks for taking the question. Just a question again on a GAMRI, you know, these patients with Duchenne often are not seeing their specialists that frequently if they're medically stable, you know, maybe once every three months, sometimes once every six months. I'm just wondering if you've seen patients coming in to switch to a GAMRI because it's now available, or are they sort of waiting for their next special deployment? to change steroids?

Leland Gershell: And thanks for taking the question. Just a question again on GAMRI, you know, these patients with Duchenne often are not seeing their specialists that frequently if they're medically stable, you know, maybe once every three months, sometimes once every six months. I'm just wondering if you've seen patients coming in to switch to Agamri. Are these now available, or are they sort of waiting for their next special deployment? to change steroids?

Speaker Change: Just a question again on a gallery.

Unknown Executive: These patients with duchenne opt in or not seeing their specialists that frequently for medically stable maybe once every three months, sometimes once every six months I'm just wondering if.

Speaker Change: If you have been seeing patients coming in to switch.

Speaker Change: So again, we think that's now available or are they.

Jason Gerber: Our next question is from Jason Gerber with Bank of America. Please proceed with your question. Hey, good morning. Thank you for my questions. Maybe just first on biz dev. Are you generally inclined to do more deals funded with cash and backend success based milestones or talk about maybe appetite to take on some leverage to go after some larger targets that could be more transformational. Great question, Jason. So we would be looking for opportunities to add to the income statement right now and look for that opportunity.

Speaker Change: Waiting for their next scheduled the appointment.

Speaker Change: <unk> changed steroids, just sort of an observational question do you have.

Speaker Change: Any perspective, there. Thank you.

Leland Gershell: Thank you.

Jeffrey Carmen: Hi, Leland. It's really Center of Excellence specific. They have some; some sites had that pent-up demand, like I mentioned earlier, where they were ready to go as soon as it became commercially available. And then, over time, they are, we'll wait for other patients to come in and have that discussion. And in other cases, there's outreach going on to the boys living with DMD and their caregivers about switching. So it really is specific. It's dependent on the staff and the physician, how they want to go, the process that they put in place. Okay, thanks very much.

Leland: Hi, Leland, it's really center of excellent specific.

Unknown Executive: Just sort of an observational question. If you have any perspective, Hi Leland, it's really a center of excellence.

Jeffrey Del Carmen: Just sort of an observational question. If you have any perspective, Hi Leland, it's really a center of excellence.

Unknown Executive: Hi Leland, it's really Center of Excellence specific. Some sites had that pent-up demand, like I mentioned earlier, where they were ready to go as soon as it became commercially available. And then, over time, they will wait for other patients to come in and have that discussion. And in other cases, there is outreach going on to the boys living with DMD and their caregivers about switching. So it really is specific. It's dependent on the staff and the physicians, how they want to go, and the process that they put in place.

Jeffrey Del Carmen: Hi Leland, it's really Center of Excellence specific. Some sites had that pent-up demand, like I mentioned earlier, where they were ready to go as soon as it became commercially available.

Unknown Executive: There's some some sites had that pent up demand like I mentioned earlier, where they were ready to go as soon as it became commercially available and then over time. They they are we'll wait for other patients to come in and have that discussion.

Jeffrey Del Carmen: And then over time, they will wait for other patients to come in and have that discussion. And in other cases, there's outreach going on to the boys living with DMD and their caregivers about switching. So it really is specific. It's dependent on the staff and the physicians, how they want to go, and the process that they put in place.

Unknown Executive: And then other cases their outreach going onto the boys living with DMD and their caregivers about switching so it really is specific it's dependent on the staff and the physician.

Jason Gerber: I think we could handle a deal or two with the cash that we have. And then I think we would probably look to dip into the leverage opportunity. After that, I think we would be looking to look for more of a transformational opportunity. We like the building of the income diversity as a stepwise function for the company. We think that's the best path forward for us. We like our product mix at this point in time.

Unknown Executive: How they wanted the process that they put in place.

Leland: Okay. Thanks very much.

Joe Katanzaro: Thank you. Our next question is from Joe Katanzaro with Piper Sandler. Please proceed with your question. Great, everybody. Thanks for taking my questions. Maybe first one, honing in on, on sort of a bit more curious.

Unknown Executive: Thank you. Our next question is from Joe Catanzaro with Piper Sandler. Please proceed with your question.

Operator: Thank you. Our next question is from Joe Catanzaro with Piper Sadler. Please proceed with your question.

Joe Catanzaro: Thank you. Our next question is from Joe Catanzaro with Piper Sadler. Please proceed with your question.

Joe Catanzaro: Great. Hey everybody.

Unknown Executive: Great. Hey everybody.

Joe Catanzaro: Great and everybody. Thanks for taking my questions, maybe first one honing in on <unk> a bit more.

Jason Gerber: And we want to build up that that strength of the income statement and continue to build the balance sheet. And at that point, I think looking at more of a transformational opportunity might any comments. So it sounds like maybe more of a sequencing of deals where or something that involved leverage would be after other deals that maybe improve your profitability and your cash flow base, then you consider larger transformational deals. That's the right way to think about it.

Joe Catanzaro: Thanks for taking my questions. Maybe the first one, honing in on per depth a bit more. I'm curious, Jeff, what do you attribute the sort of highest level of new patient starts in the quarter to? I know you cited a couple of things. Maybe you could just speak to that, which of those you expect to sort of continue and maybe which factors might fade, if at all. That'd be super helpful. And then I have one quick follow-up. Thanks.

Unknown Executive: Thanks for taking my questions. Maybe the first one, honing in on Firdef a bit more. Curious, Jeff, what do you attribute the sort of highest level of new patient starts in the quarter to? I know you cited a couple of things. Maybe you could just speak to that. Which of those do you expect to sort of continue, and maybe which factors will maybe fade, if at all? That'd be super helpful. And then I have one quick follow-up. Thanks.

Joe Catanzaro: Curious, Jeff what do you attribute the sort of highest level of new patient starts.

Joe Katanzaro: Jeff, what do you attribute the sort of highest level of new patients starts in the quarter two? I know you cited a couple of things. Maybe you could just speak to that, which of those you expect to sort of continue and maybe which factors maybe fade, if at all. That'd be super helpful. And then I have one quick follow-up. Thanks.

Unknown Executive: In the quarter or two I know you cited a couple of things maybe you could just speak to that which of those you expect to sort of continue and maybe which.

Unknown Executive: Factors, maybe fade if at all.

Unknown Executive: It'd be Super helpful. And then I have one quick follow up thanks.

Jeffrey Carmen: Sure, hey, Jo. As we constantly mention, and I think it's very important and ultra-orphine disease, is to maintain that pipeline that we always do. And that's over 500 patients that are in various stages of their lens journey. And, you know, so we have ongoing conversations between the field and the healthcare providers with those patients. Because that's where we have the most success, and about 40 to 50 percent of our new enrollment comes from those leads. So, as a team, what we constantly focus on are increasing the voltage-gated antibody testing, the VGCC antibody testing. And then when those patients are tested and if they are positive, we usually can identify where those patients are through our lead sources.

Jeff: Sure. Hey Joe.

Jeffrey Del Carmen: Sure. Hey Joe.

Jeff: Sure Hey, Joe.

Speaker Change: As we constantly mentioned and I think it's very important in ultra orphan disease.

Jeff: As we constantly mention, and I think it's very important in ultra-orphan diseases, to maintain that pipeline that we always do. And that's over 500 patients that are in various stages of their LEMS journey. And so we have ongoing conversations between the field and the healthcare providers with those patients. That's where we have the most success, and about 40 to 50% of our new enrollments come from those leads. So as a team, what we constantly focus on is increasing voltage-gated antibody testing, VGCC antibody testing, and then when those patients are tested, and if they are positive, we usually can identify where those patients are through our lead sources, and then we try to help those patients by giving those leads to our RANDs. But that's how we ensure that we always have a robust pipeline for future enrollment, and we will continue to do that, and we're always on the search for additional sources of news.

Jeffrey Del Carmen: As we constantly mention, and I think it's very important in ultra-orphan diseases, to maintain that pipeline that we always do. And that's over 500 patients that are in various stages of their LEMS journey. And so we have ongoing conversations between the field and the healthcare providers with those patients. That's where we have the most success, and about 40 to 50% of our new enrollments come from those leads. So as a team, what we constantly focus on is increasing voltage-gated antibody testing, VGCC antibody testing, and then when those patients are tested, and if they are positive, we usually can identify where those patients are through our lead sources, and then we try to help those patients by giving those leads to our RANDs. But that's how we ensure that we always have a robust pipeline for future enrollment, and we will continue to do that, and we're always on the search for additional sources of news.

Jason Gerber: I think so. Yeah, it looked when you think about what we're trying to do is build up the strength of the company. We feel like we're really in a great position right now. We feel like we're strong. We know we're strong and then as we think about the long term of the company, we want to work our way back in the pipeline. So as we build that future orientation of the company, we want to have that strong cash flow, strong balance to be able to take on that transformational opportunity.

Jeff: Is to maintain that pipeline.

Jeff: That we always do and that's over 500 patients that are in various stages of their lens journey.

Jeff: And so we have ongoing conversations between the field and the health care providers with those patients that's where we have the most success and about 40% to 50% of our new enrollments come from those leads.

Jason Gerber: Okay, and then if I can ask a question about bird apps, just the growth that you're seeing, it looks like maybe it's two thirds volume, maybe a third price mix. I assume that that volume is mostly patients that don't have small cell lung as a component of their disease. So is that kind of what you're seeing in terms of the mix and what's driving this kind of 15 to 20% growth. It's pretty accurate there.

Jeff: So as a team what we constantly focus on our.

Jeff: Increasing the voltage gated antibody testing the V GCC antibody testing and then when those patients are tested and if they are positive we usually can identify where those patients are through our lead sources and then we try to help those patients and by giving those leads to our ramp.

Jeffrey Carmen: And then we try to help those patients by giving those leads to our ramps. But that's how we ensure that we always have a robust pipeline for future enrollments. And we will continue to do that.

Jeff: We that's how we ensure that we always have a robust.

Jason Gerber: We are seeing, you know, from the non small cell lung cancer, LEMS patients, we've seen steady about a low 20% as far as our mix goes of our total LEMS patients that have small cell. So, you know, we expect that it's our opportunity moving forward to help include that share. As I mentioned on the call about 90% of those patients, small cell lung cancer LEMS patients are undiagnosed there are undiagnosed at this time.

Jeff: Pipeline for future enrollments.

Jeff: And we will continue to do that and we're always on the search to find additional sources of new leads.

Joe Katanzaro: And we're always on the search to find additional sources of new leads. Great. That's helpful.

Jeff: Okay.

Speaker Change: Great. That's helpful. And then my quick follow up I guess on portfolio expansion, Richard I've read into maybe some of your comments.

Richard Daly: Great, that's helpful. And then my quick follow-up, I guess, on portfolio expansion, Rich, I've read into maybe some of your comments as they're sort of inbound inquiries to you guys. Wondering if you could characterize the current project that you're diligence, you know, how many of those, what percent originated as inbound inquiries versus outbound inquiries? Thanks.

Joe Catanzaro: Great, that's helpful. And then my quick follow-up, I guess, on portfolio expansion, Rich, I've read into maybe some of your comments as they're sort of inbound inquiries to you guys. Wondering if you could characterize the current project that you're diligence, you know, how many of those, what percent originated as inbound inquiries versus outbound inquiries? Thanks.

Richard Daly: And then my quick follow-up, I guess, on portfolio expansion. Richard, I've read in some, maybe some of your comments as they're being sort of inbound inquiries to you guys. I wonder if you could characterize the current projects that your diligence thing. You know, how many of those, what percent originated as inbound inquiries versus outbound inquiries? Thanks.

Richard Daly: They're being sort of inbound inquiries to you guys I'm wondering if you could characterize the current.

Richard Daly: Projects that you're diligent thing how many of those what percent originated at inbound inquiries versus outbound inquiries.

Jason Gerber: So we're applying a lot of resources towards helping those patients get diagnosed sooner. So that's where our growth will be coming from. But as far as today, you're accurate about how you described the dividing up that growth. Got it. Thanks so much, guys. Thank you.

Richard Daly: That's a great question, Joe. Really, I think what we've seen now is an uptick in inbound inquiries because of the performance that we see. We're seeing, I guess the best way I can characterize it is that we are looking at the performance of the company. And now the execution; we're getting these inquiries because we're a place that people want to place their products. So I would say we're probably at a 30%, 35% of the inquiries, I'm sorry, of the products that we're talking about are inbound where people are calling us and saying, "Hey, we'd like to talk to you about an opportunity."

Rich: I'd say, that's a great question Joe.

Richard Daly: That's a great question, Joe. Really, I think what we've seen now is an uptick in inbound inquiries because of the performance that we see where we are. I guess the best way I could characterize it is that we are looking at the performance of the company and now these inquiries because we're a place that people want to place their products. So I would say we're probably at 30%, 35% of the inquiries for the products that we're talking about are inbound, where people are calling us and saying, hey, we'd like to talk to you about an opportunity.

Richard Daly: That's a great question, Joe. Really, I think what we've seen now is an uptick in inbound inquiries because of the performance that we see where we are. I guess the best way I could characterize it is that we are, we're looking at the performance of the company and now the execution. We're getting these inquiries because we're a place that people want to place their products. So I would say we're probably at 30%, 35% of the inquiries for the products that we're talking about are inbound, where people are calling us and saying, hey, we'd like to talk to you about an opportunity.

Richard Daly: I think what we see now is an uptick in inbound inquiries because of.

Richard Daly: The performance that we see we're seeing.

Richard Daly: I guess, the best way I could characterize it is that we are.

June Late: Our next question is from June late with true securities. Please proceed with your question.

Richard Daly: We're looking at.

Richard Daly: The performance of the company and now.

Jeffrey Carmen: Good morning. This is awesome. One for June, congrats on the quarter and thanks for taking questions. It was mentioned in the prepared remarks that refill rates were higher than historical norm for FedEx. Can you explain what led to that and why you expected to return back to 90% of the fallen quarters. And then also FedEx. How soon after approval of 100 milligrams dose, did you start some patients which should hire those and how much of an impact you think they had in the quarter.

Richard Daly: The execution.

Richard Daly: Getting.

Richard Daly: These inquiries.

Richard Daly: Because we're a place that people want to place their products. So I would say, we're probably at a 30% to 30% 35% of the inquiries.

Richard Daly: All of the products that we're talking about our inbound where people are calling us and saying hey, we'd like to talk to you about an opportunity.

Richard Daly: <unk>.

Richard Daly: And I think that's really exciting. You know, you can go from one product to three products in the space of about 18 months, and you're really hustling for products. And we continue to hustle for products. I want to emphasize that we are working diligently to bring on new products that fit who we are and are differentiated, which is critical for us, to have companies approach us with products that are in our space and fit. We're excited about that. So I'd say about 30-35%.

Richard Daly: And I think that's really exciting. You know, you can go from one product to three products in the space of about 18 months, and you're really hustling for products, and we continue to hustle for products. I want to emphasize that we are working diligently to bring on new products that fit who we are and are differentiated, which is critical for us to have companies approach us with products that are in our space and fit. We're excited about that. So I'd say about 30%, 35%. Okay, great. That's helpful and interesting.

Richard Daly: And I think that's really exciting.

Richard Daly: You can go from one product to three products in the space of about 18 months.

Jeffrey Carmen: Thank you. Thanks, June. And thanks for your support as well. Jeff, do you want to take that? Sure. As I had mentioned on the Q1 earnings call, we saw some impact from the change healthcare that impacted the refill rate in February. Overall, for the quarter and Q1, we were at about 86%. And so traditionally, our historical norms are 90%. In April and May, we saw recovery there and we saw higher than the 90% historical norm refill rate and it actually went up to 95% because of that.

Richard Daly: Youre really hustling for products and we continue to hustle for products I want to emphasize that we are working diligently to bring on new products that fit who we are and are differentiated which is critical for us.

Jeffrey Carmen: So patients that were impacted by that in Q1, filled their rates, filled their prescriptions more in Q2. We expect that to normalize and return to the 90% for Q3 and Q4, instilled delivering the 15% or greater growth for FedEx. As far as the 100 milligram expansion, it's a great thing for patients and healthcare providers. It really does give them the flexibility to manage and treat their LEM symptoms. Also, just a quick step back, 40% of LEM patients prior to the label expansion were on 80 milligrams.

Richard Daly: Do you have companies approach us with products that are.

Richard Daly: In our space and fit.

Richard Daly: We're excited about that so I would say about 30, 35%.

Speaker Change: Okay, Great that's helpful and interesting thanks for taking my question.

Unknown Executive: Okay, great. That's helpful and interesting. Thanks for taking my question. Thank you.

Joe Catanzaro: Okay, great. That's helpful and interesting. Thanks for taking my question. Thank you.

Joe Katanzaro: Thanks for taking my question. Thank you. Thanks for your support as well.

Unknown Executive: Thank you. Thanks for your support as well.

Operator: Thank you. Thanks for your support as well.

Speaker Change: Thanks for your support as well.

Unknown Executive: Thank you. There are no further questions at this time.

Speaker Change: Thank you there are no further questions at this time. This does conclude today's conference you may disconnect. Your lines at this time. Thank you for your participation.

Operator: Thank you. There are no further questions at this time. This does conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.

Operator: Thank you. There are no further questions at this time. This does conclude today's conference.

Unknown Executive: This does conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.

Operator: Okay.

Jeffrey Carmen: And those patients the average daily dose went up by about a milligram, 1.1 milligram, since that label expansion. We did not expect or do not expect that bolus to just happen immediately. We expect that increase in the average daily dose to reach its full impact in the subsequent quarters. So I just want to clarify, David Jeff made 50% growth is 15% growth over Q to 2023, just to clarify. So we've turned to that growth as we can do a comparison. It's, we look at Q3, 2024, the 15% growth will see us versus Q2, sorry, Q3 versus Q3, 2023. Thanks. Thank you.

Jeffrey Carmen: If you've been seeing patients coming in to switch to a Gamri, be it now available, or they sort of waiting for their next visual deployment to change steroids, just sort of an observational question, if you have any perspective there. Thank you. Hi, Leland. It's really center of excellence specific. They have some, some sites had that pent up demand, like I mentioned earlier where they were ready to go as soon as it became commercially available.

Jeffrey Carmen: And then over time, they are, we'll wait for other patients to come in and have that discussion. And in other cases, there's outreach going on to the boys living with DMD and their caregivers about switching. So it really is specific. It's dependent on the staff and the physician, how they want to go, the process that they put in place. Okay, thanks very much. Thank you.

Joseph Catanzaro: Our next question is from Joe Katanzaro with Piper Sandler. Please proceed with your question. Great, everybody. Thanks for taking my questions. Maybe first one, honing in on, on sort of a bit more curious.

Jeffrey Carmen: Jeff, what do you attribute the sort of highest level of new patients starts in the quarter two? I know you cited a couple things. Maybe you could just speak to that, which of those you expect to sort of continue and maybe which factors maybe fade if at all. That'd be super helpful. And then I have one quick follow up. Thanks. Sure, hey, Jo. As we constantly mention, and I think it's very important and ultra-orphine disease, is to maintain that pipeline that we always do.

Jeffrey Carmen: And that's over 500 patients that are in various stages of their lens journey. And, you know, so we have ongoing conversations between the field and the healthcare providers with those patients. Because that's where we have the most success, and about 40 to 50 percent of our new enrollment come from those leads. So, as a team, what we constantly focus on are increasing the voltage-gated antibody testing, the VGCC antibody testing. And then when those patients are tested and if they are positive, we usually can identify where those patients are through our lead sources.

Richard Daly: Great. That's helpful.

Richard Daly: And then my quick follow-up, I guess, on portfolio expansion. Richard, I've read in some maybe some of your comments as they're being sort of inbound inquiries to you guys. I wonder if you could characterize the current projects that your diligence thing. You know, how many of those, what percent originated as inbound inquiries versus outbound inquiries? Thanks. That's a great question, Joe. Really, I think what we've seen now is an uptick inbound inquiries because of the performance that we see.

Richard Daly: We're seeing, I guess the best way I can characterize it is that we are looking at the performance of the company. And now the execution, we're getting these inquiries because we're a place that people want to place their products. So I would say we're probably at a 30%, 35% of the inquiries, I'm sorry, of the products that we're talking about are inbound where people are calling us and saying, hey, we'd like to talk to you about an opportunity.

Richard Daly: And I think that's really exciting. You know, you can go from one product to three products in the space of about 18 months and you're really hustling for products and we continue to hustle for products. I want to emphasize that we are working diligently to bring on new products that fit who we are and are differentiated, which is critical for us to have companies approach us with products that are in our space and fit. We're excited about that. So I'd say about 30%, 35%. Okay, great. That's helpful and interesting. Thanks for taking my question. Thank you. Thanks for your support as well. Thank you.

Unknown Executive: There are no further questions at this time. This does conclude today's conference. You may disconnect your lines at this time.

Unknown Executive: Thank you for your participation.

Q2 2024 Catalyst Pharmaceuticals Inc Earnings Call

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