Q1 2024 Catalyst Pharmaceuticals Inc Earnings Call
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Operator: Greetings and welcome to the Catalyst Pharmaceuticals first quarter 2024 financial results conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Kalb. Chief Financial Officer. Thank you, sir. You may begin.
Speaker Change: Greetings and welcome to the catalyst Pharmaceuticals first quarter 2024 financial results Conference call.
Speaker Change: At this time all participants are in a listen only mode.
Speaker Change: A brief question and answer session will follow the formal presentation.
Speaker Change: If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
Speaker Change: As a reminder, this conference is being recorded.
Speaker Change: It is now my pleasure to introduce your host Mike Com.
Michael W. Kalb: Chief Financial Officer.
Michael W. Kalb: Sir you may begin.
Michael W. Kalb: Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's First Quarter 2024 Financial Results and Business Highlights. Richard Daly, President and CEO, will be leading the call today, and Jeffrey Del Carmen, our Chief Commercial Officer, and I will also be presenting. Additionally, Dr. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer, will be available for the Q&A.
Michael W. Kalb: Thank you good morning, everyone and thank you for joining our conference call to discuss catalysts first quarter 'twenty 'twenty four financial results and business highlights.
Michael W. Kalb: Richard Daly, President and CEO will be leading the call today are Jeffrey adult Carman, our chief commercial officer, and I will also be presenting.
Michael W. Kalb: Additionally, Dr. Steven Miller, our Chief operating Officer, and Chief Scientific Officer will be available for the Q&A.
Michael W. 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 are not guarantees of 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.
Michael W. 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.
Michael W. Kalb: These statements relate to our current expectations estimates and projections and are not guarantees of future performance.
Michael W. Kalb: They involve risks uncertainties and assumptions that are difficult to predict and may not prove to be accurate.
Michael W. Kalb: Actual results may vary from the expectations contained in our forward looking statements.
Michael W. 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 filed with the SEC on February 28, 2024, and in our first quarter, 2024 quarterly report on Form 10Q, which was filed yesterday with the SEC. At this time, I'll turn the call over to Rick.
Michael W. 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 on February 28, 2024, and then our first quarter 'twenty 'twenty four quarterly report on form.
Michael W. Kalb: <unk> 10-Q, which was filed yesterday with the C C.
Michael W. Kalb: At this time I'll turn the call over to rich.
Rich: Thanks, Mike.
Richard John Daly: Welcome to the Catalyst Q1, 2024 Financial Results Call. Today we will discuss our excellent performance in the first quarter, as well as our continued focus on execution, provide an update on clinical and regulatory milestones, delve into our portfolio diversification approach, and finally, provide insight into our continued delivery on financial discipline. In Q124, we delivered another quarter of strong performance with total revenues of $98.5 million.
Rich: Welcome to the catalyst Q1, 2024 financial results call.
Richard John Daly: This performance, along with our January equity raise, enhanced our substantial cash position, which totaled $310.4 million as of March 31st, 2024. During the quarter, our agility and focus on execution enabled our team to respond to opportunities in the market and drive continued growth in Firdat, successfully launch a GAMRI, and deliver on consistent performance for Phi Kappa. I want to congratulate our team for continuing to meet the challenging targets we set for them.
Rich: Today, we will discuss our excellent performance in the first quarter as well as our continued focus on execution provide an update on clinical and regulatory milestones.
Rich: Delving into our portfolio diversification approach and finally provide insight into our continued delivery on financial discipline.
Rich: In Q1, 'twenty four we delivered another quarter of strong performance with total revenues of $98 $5 million.
Rich: This performance along with our January equity raise enhanced our substantial cash position.
Rich: Which totaled $310 $4 million as of March 31st 2024.
Rich: During the quarter, our agility and focus on execution enabled our team to respond to opportunities in the market and drive continued growth in <unk> success.
Rich: Successfully launch of Gambari.
Rich: And deliver on consistent performance for five copper.
Speaker Change: I want to congratulate our team for continuing to meet the challenging targets, we set for them.
Richard John Daly: We are poised for promising growth as demonstrated by the significant milestones achieved. Firdaus continues to deliver strong, double-digit growth, a tremendous testament to our ability to drive the sustained success of the brand for more than five years.
Speaker Change: We are poised for promising growth as demonstrated by the significant milestones achieved.
Speaker Change: <unk> continues to deliver strong double digit growth a tremendous testament to our ability to drive the sustained success of the brand for more than five years.
Richard John Daly: Additionally, we successfully launched the GAMRI for Duchenne's muscular dystrophy, or DMD, on March 13th. While just over two weeks of launch performance are included in our Q1 financials, we are very excited by a Gammary's performance and potential when reviewing a Gammery's uptake trend, based on physician and patient response. We are experiencing a great deal of momentum, and this speaks to the tremendous market conditioning we did prior to the launch, as well as our ability to successfully integrate Agamery into our Catalyst Pathways patient services infrastructure. Although it's early in the launch, we believe Agamri is positioned for a significant step-up in Q2 and beyond. Jeff will provide further details about product performance during his discussion.
Speaker Change: Additionally, we successfully launched the gallery for Duchenne muscular dystrophy or DMD on March 13th.
Speaker Change: Oh, just over two weeks of launch performance are included in our Q1 financials. We are very excited by a guarantee of performance and potential when reviewing cameras uptake trends.
Speaker Change: Yeah.
Speaker Change: Based on physician and patient response.
Speaker Change: We are experiencing a great deal of momentum and this speaks to the tremendous market conditioning, we did prior to the launch as well as our ability to successfully integrate a gallery into our catalyst pathways patient services infrastructure.
Speaker Change: Although it's early in the launch we believe a gamma is positioned for significant step up in Q2 and beyond.
Speaker Change: Jeff will provide further details about product performance during his discussion.
Richard John Daly: Let's transition to Product Development and Regulatory. For IGAMRI, we are preparing to launch our previously reported long-term registry study of IGAMRI, which we have rebranded as the Summit Study. This study aims to gather long-term patient safety and quality-of-life data, offering a deeper understanding of the product's potential long-term benefits for patients. We recognize that a fundamental challenge in traditional steroid use in treating MD is the safety impact of the long-term use of these steroids. Long-term effects can cause doctors and patients to, number one, delay initiation of steroids and, number two, dose them too low to accrue the therapeutic benefits of steroids. And number three, discontinue steroid use too early.
Jeff: Let's transition to product development and regulatory.
Speaker Change: For a gambler, who we are preparing to launch our previously reported long term registry study of the gamma <unk>, which we have rebranded as the summit study.
Speaker Change: This study aims together long term patient safety and quality of life data offering a deeper understanding of the product's potential long term benefits for patients.
Speaker Change: Okay.
Speaker Change: We recognize that a fundamental challenge in the traditional steroid use in treating DMD is in the safety impact for the long term use of the steroids.
Speaker Change: Long term effects can cause doctors and patients to number one delay initiation of steroids.
Speaker Change: Number two dose to load accrued the therapeutic benefits of steroids and number three discontinue steroid use too early.
Richard John Daly: We have initiated the summit study, designed in accordance with FDA guidance for the use of real-world data to evaluate the long-term safety and quality-of-life benefits of the GAMRI. The IGAMI profile may offer patients and physicians the opportunity to start therapy sooner, optimize the effective dose, and stay on therapy longer, with the goal of potentially improving the care of patients with DMD. Moving on to FertApps.
Speaker Change: We have initiated the summit study designed in accordance with FDA guidance for the use of real world data to evaluate the long term safety and quality of life benefits of the Gambari.
Speaker Change: The a gummy profile may offer patients and physicians the opportunity to start therapy sooner.
Speaker Change: Optimize the effective dose and stay on therapy longer.
Speaker Change: With the goal of potentially improving the care of patients with DMD.
Speaker Change: Moving onto Ferd apps.
Richard John Daly: We are eagerly awaiting the June 4th, 2024 PDUFA date for our supplemental new drug application seeking to increase Firdap's maximum daily dose from 80 milligrams to 100 milligrams. If our SNDA is approved, we believe that it has the potential to provide increased therapeutic flexibility for patients and the physicians who treat them. Internationally, we continue to work with our partner in Japan, Daito Pharma, as they await word from Japanese regulatory authorities on the Firdeps Japan NDA that they filed late last year and with a decision expected around the end of Q3, beginning of Q4, this year. Next, regarding business development and portfolio diversification.
Speaker Change: We are eagerly awaiting the June 4th 'twenty 'twenty four Paducah date of our supplemental new drug application seeking to increase the first apps maximum daily dose from 80 milligrams to 100 milligrams.
Speaker Change: If our S. NDA is approved we believe that it creates the potential to provide increased therapeutic flexibility for patients and the physicians who treat them.
Speaker Change: Internationally, we continue to work with our partner in Japan, Dido pharma as they await word from Japanese regulatory authorities on the first absent Japan NDA.
Speaker Change: That they filed late last year.
Speaker Change: With the decision expected around the end of Q3 beginning of Q4 this year.
Speaker Change: Next regarding business development and portfolio diversification.
Richard John Daly: We are working on three fronts to increase our business development opportunities. First, expanding our portfolio. We are aggressively exploring opportunities to expand our portfolio in this orphaned CNS and orphan adjacent space. We are taking a comprehensive approach to decision-making, ensuring alignment with our overarching strategy for optimal success and our long-term vision. Second, we are working to expand our partnership. We are actively pursuing opportunities to expand the partnership for Firdaps in the APAC region beyond Japan and looking to enter agreements in LATAM. There is a recognized need for LEMS treatment options like Firdapse in both regions.
Speaker Change: We are working on three fronts to increase our BD opportunities first expanding our portfolio.
Speaker Change: We are aggressively exploring opportunities to expand our portfolio in this orphan CNS and orphan adjacent spaces.
Speaker Change: We are taking a comprehensive approach to approach the decision, making ensuring alignment with our overarching strategy for optimal success and our long term vision.
Speaker Change: Second we are working to expand our partnerships.
Speaker Change: We are actively pursuing opportunities to expand the partnerships for ferd apps in the APAC region beyond Japan, and looking to enter agreements in Latam.
Speaker Change: There is a recognized need for lambs treatment options like Ford apps in both regions.
Richard John Daly: Additionally, we are pursuing partnerships for a Gammary with ex-US partners in North America. Third, we are exploring opportunities to diversify and expand the use of our existing products through lifecycle management. Our teams are fully immersed in developing a GAMI lifecycle plan seeking to open up new avenues for growth for this product, and we expect to provide an update on this project during the second half of this year. Our accomplishments in the first quarter reflect our strong performance, with steady product revenue contributions and a promising product launch, further adding to our financial strength and driving our growth.
Speaker Change: Additionally, we are pursuing partnerships for a gallery with ex U S partners in North America.
Speaker Change: Third we are exploring opportunities to diversify and expand the use of our existing products lifecycle management.
Speaker Change: Our teams are fully immersed in developing in a guaranteed lifecycle plan.
Speaker Change: Seeking to open up new avenues for growth for this product and we expect to provide an update on this project during the second half of this year.
Speaker Change: Our accomplishments in the first quarter reflect our strong performance with steady product revenue contributions and a promising product launch further adding to our financial strength and driving our growth.
Richard John Daly: We are grateful to our team for delivering excellent results this quarter, which gives us further confidence as we reaffirm our full year 2024 total revenue guidance in the range of $455 million to $475 million. Mike will provide additional details on our financial performance during his discussion today. Since the outset of 2024, we have surged forward with formidable momentum, laying down solid groundwork to drive short and long-term value. We remain excited about the journey ahead. I'll now turn over the call to Jeff Del Carmen, who will provide an overview of our commercial performance.
Speaker Change: We are grateful to our team for delivering excellent results this quarter, which gives us further confidence as we reaffirm our full year 2024 total revenue guidance in the range of 455 million to $475 million.
Speaker Change: Mike will provide additional details on our financial performance during his discussion today.
Speaker Change: Since the outset of 'twenty 'twenty four we have surge forward with formidable momentum laying down solid groundwork to drive short and long term value.
Speaker Change: We remain excited about the journey ahead.
Speaker Change: I'll now turn over the call to Geoff del Carmen, who will provide an overview of our commercial performance.
Speaker Change: Jeff.
Jeffrey Del Carmen: Thanks, Rich. And good morning, everyone. Fueled by the successful execution of our strategic growth initiatives across our entire commercial portfolio, we are exceedingly pleased with our first quarter 2024 performance. As Rich mentioned, Catalyst had an excellent start to 2024, driven by the combination of sustained organic growth of FertABS, stable revenues from Ficampa, and the strong initial commercial launch of gamory. Q1 total net product revenues of $98.4 million position Catalyst well to achieve our 2024 full year total revenue guidance. First, let me start with Firdat.
Speaker Change: Thanks, Rich and good morning, everyone fueled by the successful execution of our strategic growth initiatives across our entire commercial portfolio.
Speaker Change: We are exceedingly pleased with our first quarter 2020 for performance.
Speaker Change: As rich mentioned catalyst had an excellent start to 2024, driven by the combination of sustained organic growth a third apps.
Speaker Change: Stable revenues from by copper and the strong initial commercial launch of a gambling.
Speaker Change: Q1, total net product revenues of $98 $4 million positions catalyst well to achieve our 2020 for full year total revenue guidance.
Speaker Change: First let me start with Fedex.
Jeffrey Del Carmen: Q1 2024 net sales were $66.8 million, representing a 16% increase over the same quarter last year. This is in line with our forecasted growth projections, and a direct result of a sustained cadence of new patient starts, high compliance, and consistent low discontinuation. Net new patients in Q1 2024 were the highest total since Q1 2022. We believe that these facts demonstrate that our underlying Furdap business is solid. Prescription approval rates were greater than 90% across all payers, government, or private commercial insurers.
Speaker Change: Q1, 2024, net sales were $66 8 million, representing a six 2% increase over the same quarter last year in line with our forecasted growth projections, a direct result of the sustained cadence of new patient starts I can.
Speaker Change: Clients and consistent low discontinuation rates.
Speaker Change: Net new patients in Q1 2024 were the highest total since Q1 2022.
Speaker Change: We believe that these facts demonstrate that our underlying <unk> business is solid.
Speaker Change: Prescription approval rates were greater than 90% across all payers government or private commercial insurers.
Jeffrey Del Carmen: As expected, net product revenues in the first quarter reflected the typical Q1 seasonality and the reset of deductibles and co-pays at the beginning of the year. In addition, some new patient and refill prescription adjudications were temporarily impacted by the change healthcare cyber, particularly in February.
Speaker Change: As expected net product revenues in the first quarter reflected the typical Q1 seasonality.
Speaker Change: And the reset of deductibles and co pays at the beginning of the year.
Speaker Change: In addition, some new patient and refill prescription adjudication.
Speaker Change: Were temporarily impacted by the change healthcare cyber attack, particularly in February.
Jeffrey Del Carmen: Given the intensely symptomatic nature of LEMS, we exercise Catalyst's no patient left behind approach and provided five days of free medication to any Firdeps patient who could not fill their prescription. It is our mission to ensure continuity of care for the patients we serve, and we believe that what we did supports that commitment. I am also glad to report that at the end of the day, we subsequently received reimbursement for all the five-day bridge prescriptions provided. The Firdap's refill rate was temporarily affected in February, but we saw a rapid rebound in filled prescriptions in March back to the historic norm. Our strategic growth initiatives will continue to drive organic growth moving forward.
Speaker Change: Given the intensely symptomatic nature of lens, we exercised catalyst no patient left behind approach and provided five days of free drug to any <unk> patient who could not fill their prescription.
Speaker Change: It is our mission to ensure continuity of care.
Speaker Change: Patients, we serve and we believe that what we did supports that to loopnet.
Speaker Change: I am also glad to report that at the end of the day. We subsequently received reimbursement for all the five day bridge prescriptions provided.
Speaker Change: The third Fs refill rate was temporarily affected in February but we saw a rapid rebound in filled prescriptions in March back to historic norms.
Speaker Change: Our strategic growth initiatives will continue to drive organic growth moving forward, we maintain a pipeline of approximately 500 lantus patients in various stages of their diagnostic journey that are not yet on fairness.
Jeffrey Del Carmen: We maintain a pipeline of approximately 500 LEMS patients in various stages of their diagnostic journey that are not yet on FertEx. Tracking these LEMS patients is a prime reason for our ability to consistently deliver 15 to 20 percent annual growth, as half our new patient enrollments typically come from this group. Furthermore, LEMS education programs targeting healthcare providers have already resulted in consistently higher voltage-gated calcium channel antibody testing rates, which will shorten the diagnostic journey for LEMS patients and lead to more patients being eligible for treatment with Virta.
Speaker Change: Tracking these lens patients and it is a prime reason for our ability to consistently deliver 15% to 20% annual growth.
Speaker Change: As have our new patient enrollments typically come from this group.
Speaker Change: The more lenders education programs targeting health care providers have already resulted in consistently higher voltage gated calcium channel antibody testing rates, which will shorten the diagnostic journey for lantus patients and lead to more patients being eligible for treatment with <unk>.
Jeffrey Del Carmen: Now, let me provide an update on FICOMP. We achieved solid Q1 net revenues of $30.4 million, further fortifying our revenue diversification. We expect continued stable net revenues for the rest of 2024. Furthermore, all Epilepsy Regional Account Managers have been trained on FRTAPs and LEMs, and moving forward, these RAMs will conduct secondary calls with health care providers that account for the 45% overlap in FICompa and Ferdap's position call point, further increasing Firdap's share of voice in the ability to identify new LEMS patients. Let's turn to a gammery.
Speaker Change: Now, let me provide an update on Phi compound.
Speaker Change: We achieved solid Q1 net revenues of $30 4 million further fortifying our revenue diversification.
Speaker Change: We expect continued stable net revenues for the rest of 2024.
Speaker Change: Further all epilepsy regional account managers have been trained on <unk> and lambs and moving forward. These ramps will conduct secondary calls with health care providers that account for 45% overlap and fight copper in ferd apps physician call points.
Speaker Change: Other increasing fared apps as share of voice and the ability to identify new land as patients.
Speaker Change: Let's turn to a gambling we.
Jeffrey Del Carmen: We successfully commercially launched a GAMRI on March 13, and early indicators of new patient enrollments show strong interest, exceeding initial expectations. This is primarily due to penetration of both the emplaza and the prednisone patient segment. Payer approval rates are greater than 90%, averaging less than 30 days to approval. Based on our experience with FURD apps, we expect this to improve over time. For further, to date, 63% of the DMD Centers of Excellence have enrolled at least one patient on a gamma ray since most of the prescriptions for DMD patients are written by doctors who practice in these centers of excellence.
Speaker Change: We successfully commercially launched a gambari on March 13th.
Speaker Change: Early indicators of new patient enrollments show strong interest exceeding initial expectations.
Speaker Change: This is primarily due to penetration of both the plaza and the prednisone patient segments.
Speaker Change: Payer approval rates are greater than 90%, averaging less than 30 days to approval.
Speaker Change: Based on our experience with <unk>, we expect this to improve overtime.
Speaker Change: For further to date, 63% of the DMD centers of excellence.
Speaker Change: Enrolled at least one patient on a gambling.
Speaker Change: Since most of the prescriptions for DMD patients are written by doctors, who practice in these centers of excellence. We believe this is a very positive sign for the acceptance of a gambling.
Jeffrey Del Carmen: We believe this is a very positive sign for the acceptance of Ferdafs again. In summary, we believe that we are making meaningful progress on sustained organic growth for Ferdafs, continuing to generate stable net revenues for FICOMPA, and exceeding our expectations for our revenues from a GAMRI. We are highly focused on continued commercial execution excellence and leveraging our strategies to maximize our demonstrated capability. I want to thank the entire team at Catalyst for their unwavering commitment to patients and look forward to continuing with a successful 2021. I will now turn the call back over to you.
Speaker Change: In summary, we believe that we are making meaningful progress on sustained organic growth preferred apps continuing to generate stable net revenues for five copper.
Speaker Change: In exceeding our expectations for our revenues for a gallery.
Speaker Change: We are highly focused on continued commercial execution excellence and leveraging our strategies to maximize our demonstrated capabilities.
Speaker Change: I want to thank the entire team are catalysts for their unwavering commitment to patients and look forward to continuing with the successful 2024, I will now turn the call back over to Mike.
Michael W. Kalb: Thank you, Jeff. As Virch noted, our performance during the first quarter of 2024 has set us on pace for another strong year, driven by our solid financial performance, financial discipline, and strong execution. We remain steadfast in our commitment to driving growth, leveraging strategic partnerships, and expanding our portfolio to capitalize on emerging opportunities throughout the year. We intend to continue our commitment to grow through strategic partnerships and portfolio expansion in 2024.
Michael W. Kalb: Thank you Jeff.
Michael W. Kalb: As rich noted our performance during the first quarter of 'twenty 'twenty four has set us on pace for another strong year, driven by our solid financial performance financial discipline and strong execution.
Michael W. Kalb: We remain steadfast in our commitment to driving growth leveraging strategic partnerships and expanding our portfolio to capitalize on emerging opportunities throughout the year.
Michael W. Kalb: We intend to continue our commitment to grow through strategic partnerships and portfolio expansion in 'twenty 'twenty four.
Michael W. Kalb: To support this objective, in January 2024, Catalyst sold 10 million shares of its authorized but unissued common stock to raise net proceeds of approximately $140.7 million for the purposes of funding potential future acquisitions and for general corporate purposes. Our total revenues for the first quarter of 2024 were $98.5 million, an approximate 15% increase when compared to total revenues of $85.4 million for the first quarter of 2023. Product revenue net for our lead product, FertApps, was $66.8 million, a 16% increase year-over-year compared to $57.5 million in Q1 2023.
Michael W. Kalb: To support this objective in January of 'twenty 'twenty, four catalysts sold 10 million shares of its authorized but unissued common stock tourists net proceeds of approximately $147 million for.
Michael W. Kalb: For the purposes of funding potential future acquisitions and for general corporate purposes.
Michael W. Kalb: Product revenue net for the first quarter of 2024 for FICOMPA increased to $30.4 million compared to $27.8 million for the portion of the first quarter of 2023 in which we recognized revenue following our acquisition of the product rights in late January of 2023. As a reminder, we anticipate that 2024 revenue for FICOMPA will be affected by differences in variable consideration compared to 2023 when revenues were booked under assized cost arrangements with distributors and government agencies.
Michael W. Kalb: Our total revenues for the first quarter of 'twenty, 'twenty, four or $98 $5 million, an approximate 15% increase when compared to total revenues of $85 $4 million for the first quarter of 2023.
Michael W. Kalb: Product revenue in that for our lead product first apps were $66 $8 million, a 16% increase year over year compared to $57 $5 million in Q1 2023.
Michael W. Kalb: Product revenue for the first quarter of 2024 for probably Champa increased to $34 million compared to $27.8 million for the portion of the first quarter of 2023, and which we recognized revenue following our acquisition of the product rights in late January of 'twenty to 'twenty three.
Michael W. Kalb: As a reminder, we anticipate the 'twenty 'twenty four revenue for Fi combo will be affected by differences in variable consideration to parents 'twenty twenty-three when revenues were booked under assange cost arrangements with distributors and government agencies.
Michael W. Kalb: Effective January 1st of this year, these costs are tied to arrangements between the company and those distributors and agencies, which are higher. Finally, we launched the GAMRI in mid-March, and for the short time during the first quarter that the product was commercially available, product revenue was $1.2 million. In the first quarter of the calendar year, like many companies in our industry, we are impacted by the reset of patient insurance deductibles.
Michael W. Kalb: Effective January 1st of this year. These costs costs are tied to arrangements between the company and those distributors and agencies, which are higher.
Michael W. Kalb: Finally, we launched a gamma in mid March and for the short time during the first quarter that the product was commercially available product revenue and that was $1.2 million.
Michael W. Kalb: In the first quarter of the calendar year like many companies in our industry. We are impacted by the reset of patient insurance deductibles.
Michael W. Kalb: Furthermore, in the first quarter of 2024, we reported expenses related to our annual commitment to make charitable contributions to foundations that fund LEMS patient support programs throughout the year. Cost of sales was approximately $12.5 million in the first quarter of 2024, compared to $9.9 million in the first quarter of 2023, and consisted principally of royalty. As a reminder, royalties for Ferdapps increase by 3% when net product sales exceed $100 million in any calendar year.
Michael W. Kalb: Further in the first quarter of 'twenty 'twenty four we reported expenses related to our annual commitment to make charitable contributions to foundations that fund less patient support programs throughout the year.
Michael W. Kalb: Cost of sales was approximately $12 $5 million in the first quarter of 2024 compared to $9 $9 million in the first quarter of 2023 and consisted principally of royalties as a reminder, royalties preferred apps increased by 3% when that product sells exceed $100 million in any calendar year.
Michael W. Kalb: As a result, we expect cost of sales to trend higher as this year progresses. Additionally, I would like to note that Agamri also carries a royalty in the range of low double digits to mid-20%, depending on sales achievements within a calendar. Further details on our royalty obligations for Gamery are reported in our Q-124, Form 10Q.
Michael W. Kalb: As a result, we expect cost of sales to trend higher as this year progresses.
Michael W. Kalb: Additionally, I would like to note that a gallery also carries a royalty in the range of low double digits to mid 20% depending on sales achievements within a calendar year.
Michael W. Kalb: Further details on our royalty obligations for gamma are reported in our Q1 'twenty four Form 10-Q.
Michael W. Kalb: Research and development expense was $2.6 million in the first quarter of 2024, slightly down from $3.6 million in the first quarter of 2023. At this point, as noted in the 2024 guidance we provided earlier this year, we believe that R&D expense for 2024 will be similar to 2022. SG&A expenses for the first quarter of 2024 totaled $46.9 million, compared to $29.7 million in Q1 2023, as G&A expenses moderately increased as a percentage of total operating expenses to 66% for Q1 2024 compared to 60% for Q1 2023.
Michael W. Kalb: Research and development expense was $2 $6 million in the first quarter of 'twenty 'twenty four slightly down from $3.6 million in the first quarter of 2023.
Michael W. Kalb: At this point as noted in the 'twenty 'twenty four guidance. We provided earlier this year, we believe that R&D expense for 'twenty 'twenty four will be similar to 2022.
Michael W. Kalb: SG&A expenses for the first quarter of 'twenty, 'twenty, four totaled $46 $9 million compared to $29 $7 million in Q1, 2023.
Michael W. Kalb: SG&A expenses moderately increased as a percentage of total operating expenses to 66% for Q1, 'twenty 'twenty four compared to 60% for Q1 2023.
Michael W. Kalb: The overall difference in SG&A expenses in the first quarter of 2024 was principally due to the incremental selling and marketing expenses to support the launch of the GAMRI and operating expenses for FICOMPA being present for a full quarter in Q1, 2024 when compared to approximately two-thirds of Q1, 2023, as well as the non-cash stock-based compensation charges of $3.9 million relating to the retirement of the company's former CEO and Our effective tax rate for the first quarter of 2024 was 20%, compared to 20.8% for the first quarter of 2023.
Michael W. Kalb: The overall difference in SG&A expenses in the first quarter of 'twenty 'twenty four was principally due to the incremental selling and marketing expenses to support the launch of a gallery and operating expenses for fun copper being present for a full quarter in Q1, 'twenty 'twenty four when compared to approximately two thirds of Q1 2023.
Michael W. Kalb: Well, it's the noncash stock based compensation charges of $3 $9 million relating to the retirement of the company's former CEO and CFO Vince on the terms of their respective separation agreements with the company.
Michael W. Kalb: Our effective tax rate for the first quarter of 'twenty 'twenty four it was 20% compared to 28% for the first quarter of 2023.
Michael W. Kalb: Although lower in the first quarter of 2024, we still expect our annualized effective tax rate to be slightly higher than the annual effective tax rate for full year 2023 of 24.4%. In 2024, the difference to the statutory federal income tax rate of 21% was primarily driven by state income taxes and anticipated annual permanent differences. 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.
Michael W. Kalb: Although lower in the first quarter of 'twenty 'twenty four we saw.
Michael W. Kalb: Still expect our annualized effective tax rate to be slightly higher than the annual effective tax rate in full year 2023 of 24, 4%.
Michael W. Kalb: For 'twenty 'twenty four the difference to the statutory federal income tax rate of 21%.
Michael W. Kalb: It's driven primarily was primarily driven by the state by state income taxes and anticipated annual permanent differences.
Michael W. Kalb: 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.
Michael W. Kalb: Net income before income taxes for the first quarter of 2024 was $29.1 million, a 22% decrease year over year compared to $37.3 million for the first quarter of 2023. We reported gap net income for the first quarter of 2024 of $23.3 million, or 20 cents per basic and 19 cents per diluted share, a decrease of 21% year-over-year compared to gap net income for the first quarter of 2023 of $29.6 million, or $0.28 per basic and $0.26 per diluted share.
Michael W. Kalb: Net income before income taxes for the first quarter of 'twenty 'twenty four was 21 $29 $1 million, a 22% decrease year over year compared to $37 $3 million for the first quarter of 2023.
Michael W. Kalb: We reported GAAP net income for the first quarter of 'twenty 'twenty four of $23 $3 million or 20 cents per basic and <unk> 19 cents per diluted share.
Michael W. Kalb: A decrease of 21% year over year compared to GAAP net income for the first quarter of 2023 of $29.6 million or 28 cents per basic and 26 cents per diluted share.
Michael W. Kalb: The decrease in both net income, before income taxes, and gap net income reflects a full quarter of operating expenses pertaining to FICOMPA, as well as substantial incremental operating expenses to prepare for the launch of GAMMA. It also includes one-time non-cash stock-based compensation expense that I mentioned earlier. Non-GAAP net income for the first quarter of 2024 was $46.8 million, or $0.40 per basic and $0.38 per diluted share, which excludes from GAAP net income the amortization of intangible assets related to our acquisitions of Ficampa, Agamri, and Resurgy of $9.3 million.
Michael W. Kalb: The decrease in both net income before income taxes, and GAAP net income reflects a full quarter of operating expenses pertaining to <expletive> Tampa as well as substantial incremental operating expenses to prepare for the launch of a guarantee at.
Michael W. Kalb: Stock-based compensation expense of $8.2 million, the income tax provision of $5.8 million, and depreciation of $86,000. This compares to non-GAAP net income in the first quarter of 2023 of $46.8 million, or 44 cents per basic and 41 cents per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FICOMP and Resurgi of $6.5 million Stock Base Compensation Expense of $2.9 million, the Income Tax Provision of $7.7 million, and Depreciation of $69,000.
Michael W. Kalb: Sense of $2.9 million, the income tax provision of $7.7 million and depreciation of $69000.
Michael W. Kalb: As previously reported, we ended the first quarter of 2024 with cash and cash equivalence of $310.4 million, compared to $137.6 million at December 31, 2020. The increasing cash of $172.8 million was largely driven by our January 2024 capital raise, which added approximately $140.7 million in net cash proceeds. The remaining increase in cash is driven primarily by $31.9 million in cash generated from business operations. We believe our current funds continue to allow us the financial flexibility to fund our existing R&D programs, meet our potential contractual obligations, and support our strategic initiatives, business development, and portfolio expansion efforts, leading to long-term growth and value creation.
Michael W. Kalb: As previously reported we ended the first quarter of 2024 with cash and cash equivalents of $310.4 million compared to $137.6 million at December 31st 2023 the.
Michael W. Kalb: Increasing cache of $172.8 million was largely driven by our January 2024 capital raised.
Michael W. Kalb: Chad at approximately $140.7 million in net cash proceeds the remaining increasing cash is driven primarily by $31.9 million and.
Michael W. Kalb: <unk> cash generated from business operations.
Michael W. Kalb: We believe our current funds continued to allow us the financial flexibility to fund our existing R&D programs made our potential contractual obligations and support our strategic initiatives business development and portfolio expansion efforts, leading to long term growth and value creation.
Michael W. Kalb: More detailed information and analysis of our first quarter 2024 financial performance may be found in our quarterly report on Form 10Q, which was filed with the Securities and Exchange Commission yesterday, May 8th, and can be found on our investor relations page on our website at www.catholicifarma.com. And with that, I will turn the call back over to Richard.
Michael W. Kalb: More detailed information and analysis of our first 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 may 8th and can be found in our Investor Relations page on our website at Www dot.
Michael W. Kalb: Catalyst pharma dotcom.
Richard: And with that I will turn the call back over to rich.
Richard: Thanks, Mike.
Richard John Daly: At Catalyst, our mission is resolute to pioneer first-in-class innovative medicines for patients with rare and difficult-to-treat diseases. With an expanding portfolio of commercial products and a track record of operational excellence, we are primed for ongoing success in delivering transformative therapies to the market. We look forward to providing updates on our continued progress. At this time, we'll turn the call back over to the operator, and we look forward to answering your questions. Thank you.
Richard: Catalyst our mission is resolute <unk>.
Richard John Daly: Pioneer first in class innovative medicines for patients with rare and difficult to treat diseases.
Richard John Daly: With an expanding portfolio of commercial products and a track record of operational excellence, we are prime for ongoing success in delivering transformative therapies to the market.
Richard John Daly: We look forward to providing updates on our continued progress.
Richard John Daly: At this time will turn the call back over to the operator, and we look forward to answering your questions. Thank you.
Operator: Thank you. We will now be conducting a question and answer session. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tool will indicate that your line is in the question queue, and 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 key.
Speaker Change: Thank you we will now be conducting a question and answer session.
Operator: If you would like to ask a question. Please press star one on your telephone keypad confirmation color indicate that you're lying as in the question can.
Operator: And you May press start till if you'd like to move your question for the account.
Operator: Participants using speaker equipment may be necessary to pick up your handset before pressing the star Keith one moment, please while I pull for questions.
Operator: One moment, please, while we pull for questions. Thank you. Our first question comes from the line of Joon Lee with Truist Securities. Please proceed with your question.
Joon So Lee: Thank you.
Joon So Lee: Our first question comes from the line of June Lee with tourists Securities. Please proceed with your question.
Operator: Hi, This is Jamie on Virginia, and thanks for taking my questions can you just share any specific documentation feedback on the camry experience and then any further updates on your B D plans, how long it far along are you in that search and is there a specific.
Joon So Lee: Civic therapeutic area, you are targeting such as epilepsy. Thanks.
Jeffrey Del Carmen: Thanks for the question. Jeff, do you want to handle the first part?
Joon So Lee: Thanks for the question <unk>, you Wanna handle first part sure. It it's a little early to to get some specific feedback about physicians and the efficacy that their patients are seeing with a gam ray what we can tell you is the physicians and the patients are extremely happy with the process to get on.
Jeffrey Del Carmen: Sure, but it's a little early to get some specific feedback about physicians and the efficacy that their patients are seeing with a GammaRay. What we can tell you is the physicians and the patients are extremely happy with the process to get on a GammaRay and to get the treatment. So that's first and foremost. But we do anticipate feedback about their patients here shortly. Great And that's the second part of the question. So we are aggressively
Jeffrey Del Carmen: A gambling and to get a drug so that that's first and foremost, but we do anticipate feedback about their patients here shortly.
Jeffrey Del Carmen: And that's the second part of the question. So, we are aggressively pursuing opportunities, as we mentioned on the call, in the orphan space and what we call the orphan adjacent. So we believe our infrastructure is one that really supports patient care. So when you think about what we did in the quarter and really make sure that our patients had uninterrupted care, I think it really speaks to the strategic advantage we have as a company.
Jeffrey Del Carmen: At the second part of the questions. So we are aggressively pursuing opportunities as we mentioned on the call an orphan space and what we call. The orphanage, Jason. So we believe our infrastructure is one that really supports patient care. So when you think about what we did in the quarter and really making sure that our patients had onion on it.
Jeffrey Del Carmen: Corrupt and care I think it really speaks to this strategic advantage. We have is a company. So we believe that our infrastructure supports uhm essentially any orphan opportunity and so we are out aggressively seeking opportunities across the orphan space. We believe what we are seeing our success or continued success are on.
Jeffrey Del Carmen: So we believe that our infrastructure supports essentially any orphan opportunity, and so we are out aggressively seeking opportunities across the orphan space. And we believe what we're seeing, our success, our continued success, our ongoing success with FRT apps, and our burgeoning success with the GammaRay really supports that. So we are looking pretty far and wide in the orphan space. So I would say we're pretty essentially agnostic because we believe that our infrastructure would support just about any orphan opportunity.
Jeffrey Del Carmen: Going success with Firdapse in our burgeoning success with a camry really supports that so we are looking pretty far and wide on your in the orphan space, So where I would I would say, we're pretty essentially agnostic because we believe that our infrastructure would support just about any orphan opportunity.
Jeffrey Del Carmen: You can't.
Jeffrey Del Carmen: Thanks.
Operator: Their next question comes on the line from Charles Duncan with Cantor Fitzgerald. Please proceed with your questions.
Jeffrey Del Carmen: And our next question comes from the line of Charles Duncan with Cantor Fitzgerald. Please proceed with your question.
Richard John Daly: Hey, good morning, Rich and team. Thanks for taking the question and congratulations on a nice quarter start to the year. I had a couple of them, one on a GammaRay, one on Firdapse, and then one on BD. So on the GammaRay, you mentioned new patient enrollments. Very good to hear. Can you give us some color on where you're taking patients from? Is it more Inflaza, or is it more Prednisone, and any color on that as well as the pacing of information from the new summit study? Thanks.
Charles Cliff Duncan: Hey, good morning, Rich and team. Thanks for taking the question and congratulations on a on a nice corner start the year I had a couple of them one on a camry one on for a dash and then one b D. So on a camry <unk>.
Richard John Daly: You mentioned, new patient enrollment very good to here can you give us some color on where you're taking patients from is it is it more <unk> more pregnant, it's own and any any color on that as well as your pacing up the information from the new stomach study. Thanks.
Jeffrey Del Carmen: Great, so Charles, great, thanks for the questions. And Jeff, do you want to handle the first part of the question, and we'll have Steve handle the second part?
Speaker Change: Great. So uhm Charles Great. Thanks for the questions and <unk> you Wanna handle the first part of the question is and will have Steve handle the second part.
Jeff: Sure Good morning Charles.
Jeffrey Del Carmen: When we look at the enrollments that we're getting so far for a GAMRI, 47% of our new enrollments are from patients that are currently on influenza; 43% of our patients are coming from patients that are on prednisone, and there are just a handful or a smaller percentage that were naive patients to any corticosteroids.
Jeff: When we look at the enrollments that we're getting so far for a camry 47 per cent of our new enrollments are from patients that were currently on in Plaza.
Jeffrey Del Carmen: 43 per cent of our patients were coming from patients that were on prednisone and there are just a handful or a smaller percentage that were naive patients to any corticosteroid.
Richard John Daly: And then, Charles, your second question: I believe you said the pacing of information from the summit study. Is that correct? Yes, Steve. Do you want to handle that?
Jeffrey Del Carmen: And then Charles your second question I believe you said the pacing of information from the summit study is that correct.
Richard John Daly: Yes.
Richard John Daly: Yes, Steve do you Wanna Wanna handle that.
Richard John Daly: Sure. Thank you, Rich, and thank you, Charles.
Steve: Sure. Thank you <unk>. Thank you Charles.
Steve: The stomach study is scheduled to be a five year study, we anticipate doing analyses approximately once a year, but it would depend on the nature and significance of findings that we observed during the course of the study.
Steven Miller: The summit study is scheduled to be a five-year study. We anticipate doing analyses approximately once a year, but it would depend on the nature and significance of findings that we observe during the course of the study. At the very least, the information will be published and made available to medical information staff, and, at the most, it will be submitted to the FDA under the FDA's guidance for real-world data and its use for updating product labels.
Steven Miller: At the very least the information will be published and made available to the medical information stuff in it. The most of it will be submitted to the F. D. A under the F. D. A guidance for real world data added to use for upgrading product labeling.
Steven Miller: Okay, that's helpful. And then quickly, Firdaps, yeah, looking forward to the PDUFA date, possible dose expansion. Could you remind us of, you know, roughly what percentage of patients are at maximum dose and how that decision, if it is positive to expand dosing, might impact demand for Firdaps?
Speaker Change: Okay. That's helpful. And then quickly uhm firdapse, yeah, I'm looking forward to that <unk> date.
Speaker Change: Spelled dose expansion could you remind us of you know call. It roughly what percentage of patients are at maximum dose and and how that decision. If if it is positive to expand dosing might impact the name for for a day.
Jeffrey Del Carmen: So Charles, currently 40% of active Firdeps patients are on a daily dose of 80 milligrams, which is the maximum. There are another 4% of patients that are on a dose greater than 80 milligrams, and they work directly with the specialty pharmacy to get that approved. So we do think that there's significant upside there for patients to find their optimal dose, and over time, we expect the average daily dose, which is currently at around 61 milligrams a day, to go up to approximately 65 milligrams or 66 milligrams. That is, over time. We expect for maybe the next 12 months post-expansion of the label to get to that average daily dose increase.
Speaker Change: So Charles currently 40 per cent of Firdapse patience active firdapse patients are on a daily dose of 80 milligrams, which is the maximum.
Jeffrey Del Carmen: There there are another four per cent of patients that are on a dos greater than 80 milligrams, which they work directly with the specialty pharmacy to get that approved.
Jeffrey Del Carmen: So we do think that there's a significant upside there for patients to find their optimal dose and over time, we expect the average daily dose, which is currently at around 61 milligrams a day to go up to approximately 65 milligrams or 66 milligrams.
Jeffrey Del Carmen: That is over time, we expect for for maybe the next the following 12 months post expansion on the label to get to that average daily dose increase.
Jeffrey Del Carmen: Got it. Final question, BD. Yeah, going back to the prior question. It seems like you're busy with a Gamery launch, I guess, despite the interest in additional assets, is there a goal for doing that in 24 hours, or is that really dependent on the opportunity?
Speaker Change: <unk> final question B D, yeah going back to the prior question it.
BD: It seems like you're busy with a camry launch I guess is you know despite the interest in additional assets is there a goal for doing that and 24 or or is that really dependent on the opportunity Sir okay.
Richard John Daly: It's a great question, Charles. You know, we will continue under Preeti's leadership to consider a number of opportunities. I would say the primary is to get GAMRI off the launch pad, which I think we're doing a great job getting it off the launch pad.
BD: Oh, that's a great question Charles Yeah, we will we continue under.
Richard John Daly: Under previous leadership to.
Richard John Daly: Consider a number of opportunities.
Richard John Daly: I would say primary is to get <unk> off the launch pad, which I think we're doing a great job getting it off the launch pad, but we want to be sure. We have the right opportunity, we wanna build onto C. N. S franchise, we want it to look and see where the opportunities are in the marketplace and do the right deal at the right time and we.
Richard John Daly: But we want to be sure we have the right opportunity. We want to build on the CNS franchise. We want to. John B.
Richard John Daly: .. .. .. .. ....
Richard John Daly: Wanted to be sure that we take advantage of those opportunities that come our way I think we can do additional deals, but the timing and the and the right deal has to be right for us. So we're gonna we're gonna play it play it smart to benefit the patients take advantage of the talent in the organization and obvious.
Richard John Daly: The benefit to shareholders.
Richard John Daly: Got it. Thanks, Rich, for the added color. That's helpful. Thanks, Charles. Thank you.
Speaker Change: Got it thanks rich for the added color that's helpful. Thanks, Charles Thank you.
Richard John Daly: Thank you, Charles. Thank you.
Operator: And our next question comes from the line of Jason Gerberi with Bank of America. Please proceed with your question.
Richard John Daly: And our next question comes from the line of Jason Carberry with Bank of America. Please proceed with your question.
Operator: Hey guys, thanks for taking my question. There is one BD question for me and then one a GAMRI question just on the BD front. I'm just curious, if there is a general profile range in terms of the size of the on-stage development that you look at, would you be willing to bring in an asset that wouldn't deliver sales and profit in the short term and how Firdap's litigation outcomes sort of shape your M
Jason Gerberi: Hey, guys. Thanks for taking my question one B D question for me and then one of the Camry question just on on BT front.
Operator: I'm just curious if there's a general profile range in terms of size of deals on stage development.
Operator: That you look at would you be willing to bring in an asset that wouldn't deliver sales and profit in the short term and and how Firdapse litigation outcomes sort of shape. Your your M&A aperture.
Operator: And then on gamry, maybe a little surprised just to hear, you know, lifecycle management discussion this early in the launch. Is this something that you update in the second half that could be beneficial within, you know, the IP window of a gamory or the regulatory exclusivity window of a gamory, or something that's kind of a longer-term IP-extending approach? If you can comment on that, that'd be great. Thanks.
Operator: And then on a <unk>, maybe a little surprised to hear you know lifecycle management discussion. This early in the launch is this something that you update in the second half that could be beneficial within you know the the I P window of a camry or are the regulatory exclusivity window of a <unk>.
Operator: Emery or something that's kind of a longer term I P. Extending approach if you can comment on that that'd be great. Thanks.
Richard John Daly: Thank you. Thanks for the questions.
Speaker Change: Thank you thanks for the for the questions. So on BT size and opportunity. So we would look for things at this point in our company's lifecycle for things that are immediately accretive or nearly immediately accretive we would want to take advantage of the balance sheet that Mike talked about in the call.
Richard John Daly: So on the BD size and opportunity, we would look for things at this point in our company's lifecycle for things that are immediately accretive or nearly immediately accretive. We would want to take advantage of the balance sheet that Mike talked about in the call. So when we think about size and opportunity, we would want to be really thoughtful. You know, we want to look at things that could add to the company's balance sheet immediately. So I think we would, you know, stay within ourselves, if you will. I don't want to commit to a size at this point in time.
Richard John Daly: So when we think about the size and opportunity we.
Richard John Daly: We would want to be really thoughtful you know we'd want to look at things that we could add to the to the company's balance sheet immediately. So I think we would you know.
Richard John Daly: Stay within our within ourselves if you will <unk> I don't want to commit to a size at this point in time I I I think we would again assess but really looking at those things that are very close to market or you know are are on market and again to continue to build the the the the breath of our of our capable.
Richard John Daly: I think we should, again, assess. But really looking at those things that are very close to the market or, you know, are already on the market. And again, to continue to build the breadth of our capabilities so that we can continue to build and look at larger opportunities in the future as a buy and build company. That's what we want to do. We want to build our presence in the market, and how the Firdapps litigation colors our thought on that right now, Steve can speak to the timing of that, but we assume that we're going to have a significant runway with Firdapps and Firdapps sales, and so we have an opportunity to build our portfolio, and we're going to take full advantage of that as we can do that for the time being.
Richard John Daly: <unk>, so that we can continue to build and and look at larger opportunities in the future as a a buy and build company. That's what we Wanna do we want to build our presence in the market.
Richard John Daly:
Richard John Daly: On the.
Richard John Daly: How the Firdapse litigation colors are thought on that right now Steve can speak to the timing of that but we assume that we're gonna have a significant runway with with firdapse in for an app sales and so we can we have an opportunity to build our portfolio.
Richard John Daly: We're gonna take full advantage of that as as we we can do that for the time being.
Richard John Daly: Regarding lifecycle management, we believe now is the time to be looking at opportunities for GAMRI to build a portfolio of applications for the product in rare and orphan conditions that require a steroid. We want to be that steroid of choice, and in the companies I've worked in in the past, companies typically wait too long to think about those things. And so to your point about whether it's going to be something that's applicable within the window of IP for a GAMRI, that's exactly the point.
Richard John Daly: Regarding lifecycle management.
Richard John Daly: We believe now is the time to be looking at opportunities for <unk> to build a portfolio of applications for the product and rare an orphan conditions that require a steroid we wanna be that steroid of choice and and the companies I've worked into the past typically.
Richard John Daly: <unk> companies wait too long to think about those things.
Richard John Daly: And so to your point about is it gotta be something that's applicable within the window of I P. For a camry that's exactly the point that's what we're trying to do is make sure that we can get this study's done identify those opportunities get this study's done and then take advantage of it and create value for patients and and create value for.
Richard John Daly: That's what we're trying to do is make sure that we can get the studies done, identify those opportunities, get the studies done, and then take advantage of them and create value for patients and create value for shareholders as well. Is that helpful, Jason? Yes, thank you. Thank you. Our next question comes from the line of Samantha Semenko with Citi. Please proceed with your question.
Samantha Semenko: Shareholders as well.
Samantha Semenko: This application yeah.
Samantha Semenko: Yeah. Thank you. Thanks. Thanks.
Samantha Semenko: Our next question comes from the line of Samantha cement call with city. Please proceed with your question.
Operator: Good morning, this is Eric on behalf of Sam. Thanks for taking our questions. What do you think?
Richard John Daly: Good morning. This is Eric on for Sam Thanks for taking my questions.
Speaker Change: What do you think is driving the high percentage of patients switching from prednisone and your early launch and how do you see that evolving as with progressive.
Jeffrey Del Carmen: Thanks for your question. We do think that the conversion from prednisone over to Gamry is basically because of the safety profile. And many of these patients have been on prednisone for a significant amount of time and have seen or experienced those side effects, and they're looking to transition over to GAMRI to benefit from the more positive safety profile. So over time, we do expect this mix to be about what it is today, which is very encouraging.
Speaker Change: Thanks for your question, we we do think that the conversion from private his own over to a gam rate is basically because of the safety profile and many of these patients have been on prednisone for a significant amount of time and have seen or experienced those side effects.
Jeffrey Del Carmen: And they're looking to trade they transitioned over to <unk> to benefit from the <unk>.
Jeffrey Del Carmen: More positive safety profile. So over time, we do expect this this next to be about what it is today, which is very encouraging initially during planning and forecasting we expected the initial launch to be primarily for.
Jeffrey Del Carmen: Initially, during planning and forecasting, we expected the initial launch to be primarily from the MFLAZA patients, or those patients that were used to being on a branded corticosteroid. We are encouraged by this because now we're open to the entire corticosteroid market for boys living with DMD, and that's what we're seeing and that's what we expect moving forward.
Jeffrey Del Carmen: The plaza patients or those patients that we're used to being on a branded corticosteroid. We are encouraged by this because now we're we're now opened up to the entire corticosteroid market for boys living with the M D and that's what we're saying and that's what we expect moving forward.
Operator: Our next question comes from the line of Joe Cananzaro with Piper Sandler. Please proceed with your question.
Speaker Change: Thank you.
Jeffrey Del Carmen: Our next question comes from the line of gel can Sarah with Piper Sandler. Please proceed with your question.
Operator: Everybody, thanks so much for taking my questions. I have a few on Agamri.
Joseph Michael Catanzaro: Everybody. Thanks, so much for taking my question a few on on a non Marie if I recall correctly. I think you had said there were about 28 patients in the EAP program I'm wondering if you could just sort of speak to what percent of those patients have been able to transition to commercial reimbursed drug and then maybe.
Jeffrey Del Carmen: If I recall correctly, I think you had said there were about 28 patients in the EAP program. I'm wondering if you could just sort of speak to what percent of those patients have been able to transition to commercially reimbursed drugs, and then maybe if you could also sort of speak to the current cadence of intake forms, maybe how the current rate compares to your pre-launch experience, where you indicated there was a sort of indication of significant pent-up demand. I am wondering if the current cadence of intake forms continues to point to that pent-up demand. Thanks, and I have maybe one follow-up question.
Jeffrey Del Carmen: You could also sorta speak to the current cadence of intake form maybe how the current rate compares to your prelaunch experience.
Jeffrey Del Carmen: You indicated you know there was a sort of indication of significant pent up demand. So I'm wondering if current cadence of intake form continues to point to that pent up demand. Thanks, and I have maybe one follow up.
Jeffrey Del Carmen: Jeff, do you want to take this?
Jeffrey Del Carmen: Sure.
Jeffrey Del Carmen: Sure, so I can point to first the cadence of the enrollments. We started accepting pre-commercial launch enrollments in December, and we saw significant pent-up demand. We also knew at that time that there were centers of excellence that were waiting for an announcement of the official commercial launch date, so they were holding some enrollments until that announcement. Post announcement, we started releasing volume increases that validated our confidence in the launch.
Jeffrey Del Carmen: I think that <unk>.
Jeff: Sure. So I can point to first about the the cadence of the enrollments.
Jeffrey Del Carmen: And since the commercial launch, we continue to see steady enrollments that are steady at a high level, higher than what we had forecasted, which is very encouraged. And Joe, can you remind me of your first question?
Jeffrey Del Carmen: We we started accepting pre commercial launch enrollments in December and we saw significant pent up demand.
Jeffrey Del Carmen: We also knew at that time that there were the centres of excellence that were waiting for an announcement of the official commercial launch date. So they were holding some enrollments until that announcement.
Jeffrey Del Carmen: Post announcements, we started releasing volume increase.
Jeffrey Del Carmen: That that validated our confidence in the launch and since the commercial launch we continue to see steady enrollments that key that are hot steady at a high level higher than what we had forecasted which is very encouraging.
Jeffrey Del Carmen: <unk> can you remind me of your first question about.
Jeffrey Del Carmen: If you could share with us about the EAP patients, what percent have been able to transition to commercially reimbursed drugs?
Joe: Yeah, I'm really curious about that.
Jeffrey Del Carmen: Patient sort of what percent have been able to transition to a commercial reimburse drug.
Jeffrey Del Carmen: Correct, of the 28, over half of those patients are on reimbursed shipments right now, and the rest are still in process.
Joe: Correct up to 28 over half of those patients are on reimbursed.
Joe: Shipments right now and the rest are still in process.
Richard John Daly: Okay, great, and it made me my follow-up question, still on Agomery. You guys had mentioned a step up in 2Q that you're expecting. Maybe you could just help contextualize that a little bit, how much of that will be driven by patients already on drugs seeing a full three months of treatment versus expectations around new patients starting. Thanks again for taking my questions.
Speaker Change: Okay, great and it and it made me my follow up on still on a comrade you guys had mentioned a step up in two Q that you're expecting maybe you could just help contextualize that a little bit how much of that will be driven by patients already on drugs being a full three months of treatment versus expectations around new patients starts.
Richard John Daly: Thanks again for taking my question.
Richard John Daly: Sure. So just to start off, as Jeff mentioned, we saw this nice curve of patients enrolling prior to launch, and physicians were waiting. And then with the announcement of the launch, we did see an increased enrollment, which was great. So we expect this rollover to happen. And as Jeff mentioned in his comments, it takes about, currently takes about four weeks to convert these patients from enrollment to reimbursement.
Speaker Change: Sure. So just to start off as Jeff mentioned, we saw this nice curve of patients enrolling prior to launch an physicians were waiting and then with the announcement of the launch we did see it.
Richard John Daly: Increased enrollment, which was great. So we expect this rollover to happen.
Richard John Daly: And as Jeff mentioned in his comments it takes about currently taking about four weeks to convert these patients from enrollment too reimbursed. So that's gonna roll over into the second quarter. So we're really excited about that and you know these physicians waiting too.
Richard John Daly: So that's going to roll over into the second quarter. So we're really excited about that. And, you know, these physicians are waiting for the launch. Obviously, now we're going to see that impact in the second quarter. But Jeff, do you want to take the rest of it?
Richard John Daly: Launch, obviously now we're gonna see that impact in the second quarter, but Jeff do you want to take the rest of them, well said and well stated rich and just.
Jeffrey Del Carmen: Well said and well stated, Rich. And just to add to that, we do expect the current positive payer landscape to improve even more over time. So that four weeks that Rich mentioned, we expect that to reduce. Within six months, we could potentially see it fall to about one to two weeks from time of complete enrollment to reimbursement shipment. That's our expectation, and then the other part is balanced by a significant volume of enrollments that we continue to see. So on both ends is where we are, why we have confidence in that step up in Q2. Okay, great.
Jeffrey Del Carmen: Add onto that we do expect that the current positive hair landscape to improve even more overtime. So that four weeks that rich mentioned, we expect that to reduce within six months, we do potentially see it to about one to two weeks.
Jeffrey Del Carmen: From time of completed enrollment to reimburse shipment, that's our expectation and then the other part is balanced by a significant volume of enrollments that we continue to see so on both ends is where are we.
Jeffrey Del Carmen: Why we have confidence in that step up in Q2.
Jeffrey Del Carmen: Okay, great. Thanks again. Thank you. Thank you. As a reminder, if you would like to ask a question...
Speaker Change: Okay, great. Thanks again.
Speaker Change: Thank you.
Operator: Thank you. As a reminder, if you would like to ask a question, please press star one on your telephone keypad. One moment, please, while we pull for questions. Thank you. We have reached the end of our question and answer session, and with that, this concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
Speaker Change: Thank you as a reminder, if you would like to ask a question. Please press star one on your telephone keypad one moment, please while we pull for questions.
Operator: Thank you.
Operator: We have reached the end of our question and answer session and with that this concludes today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation.
Operator: [music].
Operator: Copyright © 2020 Mooji Media Ltd. All Rights Reserved. No part of this recording may be reproduced without Mooji Media Ltd.'s express consent. ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music
Operator: Mmm.
Operator: [noise].
Operator: [noise] mm.
Operator: [music].