Q1 2024 Madrigal Pharmaceuticals Inc Earnings Call
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Operator: Good day. Thank you for standing by. Welcome to Madrigal Pharmaceuticals' first quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode.
Speaker Change: Good day, and thank you for standing by welcome to medical.
Speaker Change: Pharmaceutical first quarter 2024 earnings conference call at this time, all participants on a listen only mode. After the speaker's presentation there'll be a question and answer session. As a reminder, today's conference is being recorded I would now like to what to do with T that mature Chief Investor Relations Officer. Please go ahead.
Operator: After the speaker's presentation, there will be a question and answer session. As a reminder, today's conference is being recorded. I would now like to introduce Ms. Tina Ventura, Chief Investor Relations Officer.
Tina E. Ventura: Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you, Liisa. Good morning, everyone.
Thank you Lisa good morning, everyone and thank you for joining us to discuss <unk> first quarter 2024 earnings call. We issued a press release. This morning. There's also a supplementary slide deck that accompanies this webcast that we'll post immediately following the call on the Investor Relations section of our website.
Tina E. Ventura: And thank you for joining us to discuss Madrigal's first quarter 2024 earnings call. We issued a press release this morning. There's also a supplementary slide deck that accompanies this webcast that we'll post immediately following the call on the investor relations section of our website. On the call with me today are Bill Sibold, Chief Executive Officer, and Marty Deer, Chief Financial Officer. They'll provide prepared remarks, and then we'll take your questions. We're shooting to keep today's call to about 45 minutes. Please note, we'll be making certain forward-looking statements today. We refer you to our SEC filings for a discussion of the risks that may cause actual results to differ from the forward-looking statement. With that, I will now turn the call over to Bill. Well, thanks, Tina.
Speaker Change: On the call with me today is the civil Chief Executive Officer, and Mardi Dier, Chief Financial Officer.
Speaker Change: They'll provide prepared remarks, and then we'll take your questions. We're shooting to keep todays call to about 45 minutes.
Speaker Change: Please note, we'll be making certain forward looking statements today, we refer you to our SEC filings for a discussion of the risks that may cause actual results to differ from the forward looking statements with that I will now turn the call over to Bill well. Thanks, Dana Good morning, and thanks to everyone for joining the call today.
William J. Sibold: Good morning, and thanks to everyone for joining the call today. Before we begin, I wanted to take a moment to acknowledge Dr. Stephen Harrison, who passed away at the end of April. Becky and I attended his Celebration of Life last week.
Bill: Before we begin I wanted to take a moment to acknowledge Dr. Stephen Harrison, who passed away at the end of April.
Bill: Becky and I attended his celebration of life like last week.
William J. Sibold: Stephen was a leader in the field and a great partner with Madrigal as our principal investigator for the Maestro Nash trial. He worked closely with Becky and had the same tenacity and determination to bring Res Diffra through clinical development and ultimately FDA approval as the first medicine approved for Nash's disease. We're grateful for his years of dedication in this field, and our thoughts go out to his family, friends, and colleagues. I know that many of you listening to our call today knew Stephen well.
Bill: One was the leader in the field and a great partner with magical as our principal investigator for the Maestro Nash trial. He worked closely with Becky and had the same tenacity and determination to bring rates differ through clinical development and ultimately FDA approval is the first medicine approved for Nash.
Bill: We're grateful for his years of dedication that advance this field and our thoughts go out to his family friends and colleagues I know that many of you listening to our call today and as Stephen well.
William J. Sibold: I'll now move to our earnings call and an update on the business. We're off to a terrific start in 2024 and have made substantial progress against our goal to establish Madrigal as the clear leader in that. We achieved U.S. FDA approval on March 14. This followed the landmark publication of our Phase III trial in the New England Journal of Medicine. Following approval, our field teams were deployed, and Madrigal's patient support program was up and running. In April, we started shipping product to our specialty pharmacy network, and most importantly, patients started receiving this differently. From a supply perspective, we are confident in our ability to fully meet demand.
Bill: I'll now move to our earnings call and an update on the business.
Bill: We're off to a terrific start in 2024 and have made substantial progress against our goal to establish magical as the clear leader in Nash, we achieved U S. FDA approval on March 14.
Bill: This followed the landmark publication of our Phase III trial in the New England Journal of Medicine.
Bill: Following approval our field teams were deployed and magical patient support program was up and running in April we started shipping product to our specialty pharmacy network and most importantly patients started receiving is different.
Bill: From a supply perspective, we are confident in our ability to fully meet demand.
William J. Sibold: As we work to expand our leading position in NASH, we're also focused on maximizing the value and future growth of RISDFRA. To that end, so far this year, we submitted RISDFRA for approval in Europe, our MAA was validated, and we expect a decision in the first half of 2025. We continue to advance the Meister and Ash outcomes trial in F2-F3 patients, and we have the potential to provide first-in-disease outcomes data years ahead of others.
Bill: As we work to expand our leading position in Nash. We're also focused on maximizing the value and future growth of breath differ.
Bill: To that end so far this year, we submitted <unk> for approval in Europe, Our MAA was validated and we expect a decision in the first half of 2025.
Bill: We continued to advance the maestro Nash outcomes trial in up to three patients and we have the potential to provide first in disease outcomes data years ahead of others.
William J. Sibold: We continue to enroll our outcomes trial in NASH patients with cirrhosis to expand the eligible patient population, which has the potential to double the resdiffer opportunity. And finally, we raised $690 million in gross proceeds from our public offering. As of March 31, we had $1.1 billion in cash on our balance sheet, enabling us to fully fund the lot.
Bill: We continue to enroll our outcomes trial in Nash patients with cirrhosis to expand the eligible patient population, which has the potential to double the rent defer opportunity and.
Bill: And finally, we raised $690 million in gross proceeds from our public offering.
Bill: As of March 31, we had $1 $1 billion in cash on our balance sheet, enabling us to fully resource the launch so.
William J. Sibold: So, we've accomplished a great deal through the first quarter of this year and are laser-focused on a successful U.S. launch of RISDIPRA. You've heard my enthusiasm since I joined Madrigal about this opportunity, the clear unmet need, the product profile, and the strong label. And my reason to believe has only been reinforced by the launch.
Bill: We've accomplished a great deal through the first quarter of this year and are laser focused on a successful U S launch of <unk> is different.
Bill: You've heard my enthusiasm since I joined magical about this opportunity the clear unmet need the product profile and the strong label.
Bill: And my reason to believe has only been reinforced with the launch I've been out in the field since approval engaging with the community and the feedback has been overwhelmingly positive my sample sizes and small I've met with more than 100 prescribers at their offices in the field with our reps at our speaker training and.
William J. Sibold: I've been out in the field since approval, engaging with the community, and the feedback has been overwhelmingly positive. My sample size isn't small. I've met with more than 100 prescribers at their offices, in the field with our reps, at our speaker trainings, and at conferences. And as I think back on the launches that I've led in my career, I haven't seen this level of anticipation for any new drug launch that I've been part of. I'm more confident today that Resdipra will be a significant success for Madrigal and especially for the patients that have been waiting for this therapy. Much of the positive feedback has been about the ResDiffer product profile.
Bill: Conferences and as I think back on the launches that I bled in my career I haven't seen this level of anticipated anticipation for any new drug launch that had been part of I am more confident today that red <unk> will be a significant success for madrigal and especially for the patients that have been waiting for this therapy.
Bill: Much of the positive feedback has been about the Reds different product profile on slide four as we discussed on our approval call Red differ has the best case label that positions <unk> as a foundational therapy in Nash.
William J. Sibold: On slide four, as we discussed on our approval call, ResDiffer has a best case label that positions it as a foundational therapy in NASH. We have a great indication statement: Resdifra is indicated in NASH patients with moderate to advanced fibrosis, exactly the patients we studied in our trials. There is no biopsy requirement.
Bill: We have a great indication statement, rather defer as indicated in Nash patients with moderate to advanced fibrosis exactly the patients. We studied in our trials. There is no biopsy requirement. Its a liver directed oral once daily pill with simple weight based dosing.
William J. Sibold: It's a liver directed oral once daily pill with simple weight-based dosage. And there are no contraindications, no box warning, and no monitoring requirements beyond standard of care. We have the enviable position of being the first to market in NASH, which we believe will give us a strong and sustainable competitive advantage. First-to-market medicines usually achieve and maintain higher market share versus subsequent entry. We intend to take full advantage of this opportunity, positioning ourselves for long-term leadership.
Bill: And there are no contra indications no box warning and no monitoring requirements beyond the standard of care.
Bill: We have the enviable position of being the first to market in Nash, which we believe will give us a strong and sustainable competitive advantage first to market medicines, usually achieve and maintain higher market share versus subsequent entrants, we intend to take full advantage of this opportunity positioning ourselves for long term leadership.
William J. Sibold: As we're first to market with a product profile that's incredibly strong, as you can see on slide five, it's a liver-directed medicine that has set a high bar for efficacy, the only medicine to achieve statistically significant results on both endpoints in phase three, NAS resolution and fibrosis improvement. Importantly, Resdifra stops or improves fibrosis in more than 80% of patients after only 52 weeks or one year of therapy.
Bill: As were first to market with the product profile that is incredibly strong as you can see.
Bill: On slide five it's a liver directed medicine that has set a high bar for efficacy the only medicine to achieve statistically significant results on both endpoints in phase III Nash resolution and fibrosis improvement.
Bill: Importantly, reds different stops or improves fibrosis and more than 80% of patients. After only 52 weeks or one year of therapy, it's well tolerated tolerated with safety data in more than 2000 patients.
William J. Sibold: It's well tolerated, with safety data in more than 2,000 patients, and we've resourced to launch the right way to build toward our aspirations for peak sales. So while Madrigal, the company, might be launching its first ever medicine, our commercial and medical leaders are veterans. Each has more than 25 years of industry experience and has launched dozens of blockbuster medicines. Our field team averages nearly 20 years of experience with strong hepatologists and gastroenterologists, pardon me. relationships.
Bill: And we have resource to launch the right way to build toward our aspiration for peak sales.
Bill: While magical the company might be launching its first ever medicine, our commercial and medical leaders are veterans. Each has more than 25 years of industry experience and have launched dozens of blockbuster medicines, our field team averages nearly 20 years of experience with strong Herpetologist and Gastroenterologists.
Bill: The relationships, we have the team the talent and the resources to make this launch a success.
William J. Sibold: We have the team, the talent, and the resources to make this launch a success. With this product profile and first-market advantage, as seen on slide six, we believe Resdifra will be positioned as the foundational therapy for NASH patients with F2F3 fibrosis, now as the only FDA-approved medicine for NASH and for many years to come. The unmet need is significant, and it's urgent. There are 315,000 F2F3 patients diagnosed today under the care of the specialists we are calling on who need a liver-directed, well-tolerated therapy like Resdifra that will stop or reverse their disease.
Bill: With this product profile and first to market advantage as seen on slide six we believe Reds defer it will be positioned as the foundational therapy for Nash patients with <unk> fibrosis now as the only FDA approved medicine for Nash and for many years to come.
Bill: Unmet need is significant and it's urgent there are 315000 F. Two F. Three patients diagnosed today under care of the specialists, we are calling on who need a liver directed well tolerated therapy like that risk differ that will stop or reverse their disease. These patients are on the cusp of cirrhosis.
William J. Sibold: These patients are on the cusp of cirrhosis, are at a 10 to 17 times higher risk of liver-related mortality, and don't have time to wait. Our trial in F4 patients with well-compensated cirrhosis is underway to expand res different indication to even more severe patients.
Bill: Or at a 10% to 17 times higher risk of liver related mortality and don't have time to wait.
Bill: Our trial in that for patients with well compensated cirrhosis is underway to expand <unk> indications to even more severe patients.
William J. Sibold: Let's move to the RISDFRA launch progress on slide seven. As we discussed on our approval call in March, over the first 12 months of launch, we are focused on wiring the system. With a first in disease medicine, it's about spending the necessary time up front with physicians and their office staff to create the care pathways for patients.
Bill: Let's move to the rent different launch progress on slide seven as we discussed on our approval call in March over the first 12 months of launch we are focused on wiring the system with a first in disease medicine, it's about spending the necessary time upfront with physicians and their office staff.
Bill: To create the care pathways for patients.
William J. Sibold: This work builds the strong foundation needed to support the future volume of prescriptions we expect. We are making great progress. ResDiffer has been added to the compendia and subsequently to many electronic medical record systems so that it can be more efficiently prescribed.
This work builds the strong foundation needed to support the future volume of prescriptions. We expect we are making great progress, whereas differ has been added to the compendium and subsequently to many electronic medical record systems. So that it can be more efficiently prescribed.
William J. Sibold: Our field team was trained on the Red Differ label post-approval, enabling them to start calling on their target position. Our teams are educating providers on the disease and red ziphyra, as well as the operational aspects of prescribing and ensuring access for patients. This often takes additional calls up front to familiarize all key staff at the practice with these details and address their questions.
Bill: Our field team was trained on the different label post approval.
Bill: Billing them to start calling on their target physicians. Our teams are educating providers on the disease under its there for us as well as the operational aspects of prescribing and ensuring access for patients. This often takes additional calls upfront to familiarize all key staff that the practice with these details and address their questions.
William J. Sibold: This process will become more and more established as we progress through the year, particularly as commercial payers continue to make different coverage decisions and as physician offices become educated on those payer requirements. And we expect full Medicare coverage in place beginning early next year, which is another step towards having patients flow more efficiently through the office. So to evaluate our early progress, we are measuring a number of leading indicators, as seen on slide 8.
Bill: This process will become more and more established as we progress through the year, particularly as commercial payers continue to make really differ coverage decisions and as physician offices become educated on those payer requirements and we expect full Medicare coverage in place beginning early next year, which.
Bill: As another steps to step towards having patients flow more efficiently through the offices.
Bill: So to evaluate our early progress we are measuring a number of leading indicators as seen on slide eight it's about targeting the right doctors with the right level of frequency to build the breadth and depth of prescribers needed to achieve our aspiration.
William J. Sibold: It's about targeting the right doctors with the right level of frequency to build the breadth and depth of prescribers needed to achieve our aspiration. The metrics so far are very encouraging, especially since we're less than a month out from when the product was shipped. We are driving breadth and depth. Our sales team has already reached more than 80% of their top position target.
Bill: The metrics so far are very encouraging, especially since we're less than a month out from when product was shipped.
Bill: We are driving breadth and depth. Our sales teams has already reached more than 80% of their top physician targets. There is remarkable interest and our reps are getting access to efficient to physicians that typically don't see reps. They are engaging with our staff to ensure that many of those wiring the system activity.
William J. Sibold: There is remarkable interest, and our reps are getting access to physicians that typically don't see reps. They are engaging with the staff to ensure that many of those wiring-the-system activities I just discussed are completed to allow an office to more efficiently prescribe Resdifra. And as payers increase their coverage of Resdifra, and physician offices build their understanding of the coverage requirements, the volume and pace of prescriptions will increase.
Bill: <unk> I just discussed are completed to allow an office to more efficiently prescriber is different.
Bill: And as Payors increase their coverage of rent deferral and physician offices build their understanding of the coverage requirements the volume and pace of prescriptions will increase.
William J. Sibold: We are targeting the right physicians. 75% of prescriptions to date are coming from our top targets. We are driving our efforts from the top down as well as from the bottom up. Wiring the system extends beyond individual practices to the large health systems, the IDNs, GI supergroups, the really big systems across the country. We have an experienced team that has strong relationships across these key accounts, and they are all interested in establishing care pathways for NASH patients that are at various stages of implementation. This means that a physician, through their EMR system, has a clear guideline to identify, diagnose, and treat their NASH patients with moderate to advanced fibrosis. Importantly, these pathways filter down to the associated individual practices.
Bill: We are targeting the right physicians, 75% of prescriptions to date are coming from our top targets.
Bill: We are driving our efforts from the top down as well as from the bottom up wire.
Wiring the system extends beyond individual practices to the large health systems, the Ibms Gi Super groups, the really large systems across the country. We have an experienced team that has strong relationships across these key accounts and they are all interested in establishing care pathways for Nash patients that are at various stage.
Bill: <unk> of implementation.
Bill: That this means that a physician through their EMR system has a clear guideline to identify diagnose and treat their nash patients with moderate to advanced fibrosis.
Bill: Importantly, these pathways filter down to the associated individual practices. Another proof point that not just that a practice level, but at a system level. The launch is progressing well.
William J. Sibold: Another proof point that not just at a practice level but at a system level, the launch is progressing well. We are educating healthcare providers on Resdiffra to drive clinical conviction for the medicine. We've held speaker training meetings, national broadcasts, symposia at conferences, and local programs across the country.
Bill: We are educating healthcare providers on res different to drive clinical conviction for the medicine, we felt speaker training meetings national broadcast symposia at conferences and local programs across the country. There is phenomenal interest to attend these meetings more than 1200 prescribers attended the national broadcast are very high.
William J. Sibold: There is phenomenal interest in attending these meetings. More than 1200 prescribers attended the national broadcast, a very high turnout compared to the industry.
Bill: Turn out compared to industry benchmarks.
William J. Sibold: We are engaging with payers. To that end, coverage is in place for 30% of commercial lives, tracking right in line with our goal to achieve 80% by year end. Our reimbursement team continues to have active dialogue with payers with a focus on the comprehensive risk different clinical data set and the use of noninvasive tests or NITs as a means for patient identification and monitoring. We expect many of the larger plans to begin to cover Residris in the months ahead as they work through the typical P&T committee processes and determine prior authorization criteria.
Bill: We are engaging with payers to that end coverage is in place for 30% of commercial lives tracking right in line with our goal to achieve 80% by year end. Our reimbursement team continues to have active dialogue with payers with a focus on the comprehensive British different clinical dataset and the use of noninvasive tests or <unk>.
Bill: As a means for patient identification and monitoring.
Bill: We expect many of the larger plans to begin to cover Red is different in the months ahead as they worked through the typical PMT committee processes and determined prior authorization criteria. The criteria, we are discussing with payers and what we are seeing in early coverage are generally aligned with our label. We also expect medical society.
William J. Sibold: The criteria we're discussing with payers and what we are seeing in early coverage are generally aligned with our label. We also expect medical societies, such as the AASLD, to publish updated NASH treatment guidelines that will include Res Dipra and help reinforce for both physicians and payers how and when to use the medicine.
Bill: Such as the <unk> to publish updated Nash treatment guidelines that will include rents Debra and help reinforce for both physicians and payers, how and when to use the medicine.
William J. Sibold: Of course, we know you're interested in patient numbers, and we'll share more details on patients on our next quarterly call. What we've seen to date is really encouraging. Patient growth is accelerating, which correlates well with the leading indicators we just described and the progress our team is making as we continue to call on more prescribers, spend time with the staff, and activate more. The positive momentum we're seeing is also confirmed by market research, as noted on slide nine. 90% of physicians familiar with Resdipra believe it offers high clinical utility.
Bill: Of course, we know you're interested in patient numbers and we will share more details on patients on our next quarterly call. What we've seen to date is really encouraging patient growth is accelerating which correlates well with the leading indicators. We just described and the progress our team is making as we continue to call on more prescribers spend time with the staff and activate.
Bill: More accounts.
Bill: The positive momentum. We're seeing is also confirmed by market research as noted on slide nine.
Bill: 90% of physicians familiar with brands different believe it offers high clinical utility.
William J. Sibold: More than 80% are enthusiastic about ResDiffer's final label and cited its efficacy, no biopsy requirement, and simple dosage as the top three reasons. And in our most recent wave of research with our top physician targets, 78% of respondents said they have prescribed or intend to prescribe Resdifra within the next one to two months. Spherix, an independent market research firm, reported similar findings, with more than 75% of providers expecting to prescribe resdifra within six months of loss.
Bill: More than 80% are enthusiastic about risk difference final label and cited its efficacy no biopsy requirement and simple dosing has the top three reasons and in our most recent wave of research with our top physician targets, 78% of respondents said they have prescribed or intend to prescribe <unk> differ.
Bill: Within the next one to two months.
Bill: <unk>, an independent market research firm reported similar findings with more than 75% of providers expecting to prescribed risks differ within six months of launch.
William J. Sibold: We're engaging diagnosed patients in a very targeted way as well. Our direct-to-patient disease education campaign on slide 10 has been underway for a little over a year now to provide patients with NASH information and resources. Post-approval, the team is now focused on activating those patients to ask their doctors about Red Dipper. Patients are engaged, and 50% of those who registered on the site have downloaded a doctor discussion. In addition to the US launch of Red Dipper, we are making progress in other areas that will extend our leadership, including maintaining our scientific presence at key medical meetings.
Bill: We're engaging diagnosed patients in a very targeted way as well our direct to patient disease education campaign on slide 10 has been underway for a little over a year now to provide patients with Nash information and resources post approval. The team is now focused on activating those patients to ask there.
Bill: Doctor about read different patients are engaged and 50% of those who registered on the site have downloaded a doctor discussion guide.
Bill: In addition to the U S launch of Red Deborah we're making progress in other areas that will extend our leadership, including maintaining our scientific presence at key medical meetings.
William J. Sibold: On slide 11, you can see we are building on our strong HEOR foundation with additional publication. At the recent AMCP scientific meeting, we received recognition for our abstract that showed NASH patients were progressing even more rapidly than we thought to advanced liver states like cirrhosis, liver cancer, liver transplantation, and death. In fact, of those that progressed, 80% progressed directly to decompensated cirrhosis instead of cirrhosis, as one would expect.
Bill: On Slide 11, you can see we are building on our strong AQR Foundation with additional publications at.
Bill: At the recent AMC <unk> scientific meeting we received recognition for our abstract that showed Nash patients were progressing even more rapidly than we thought to advanced liver states like cirrhosis liver cancer liver transplant and death.
Bill: In fact of those that progressed, 80% progress directly to D. Compensated cirrhosis instead of cirrhosis as one would expect the.
William J. Sibold: The results are particularly impactful because this data is from an Optum database, which includes commercially insured patients that are likely receiving better care and are of higher socioeconomic status compared to NASH patients and other care. The annual cost per patient that progressed was two-fold higher when compared to those that didn't, with the cost gap increasing over time. In conclusion, therapies like resdifra that help stop or improve fibrosis may help alleviate the financial burden of, We will also have a strong presence at the upcoming DDW meeting in DC later this month and at the EASL Congress in Milan in June, where 11 abstracts have been accepted.
Bill: The results are particularly impactful because this data is from an Optum database, which includes commercially insured patients that are likely receiving better care and are of higher socioeconomic status compared to Nash patients and other care settings.
Bill: The annual cost per patient.
Bill: Progressed was twofold higher when compared to those that didn't with the cost gap increasing over time, but.
Bill: The conclusion therapies like Brent differ that helps stop or improved fibrosis may help alleviate the financial burden of Nash.
Bill: We will also have a strong presence at the upcoming BBW meeting in DC later this month.
Bill: The easel Congress in Milan in June were 11 abstracts have been accepted.
William J. Sibold: As I referenced at the start of the call, we look to further differentiate and expand the ResDiffer label with data from the outcomes portion of our Pivotal Phase III Maestro NASH trial and our Maestro NASH outcomes trial in well-compensated cirrhosis or at 4-pH. As noted on slide 12, these studies will allow us to generate outcomes data years in advance of any potential competitor outcomes data, expand our indication, and further extend our leadership in that.
Bill: As I referenced at the start of the call we look to further differentiate and expand.
Bill: As different label with data from the outcomes portion of our pivotal phase III Maestro Nash trial, and our Maestro Nash outcomes trial in well compensated cirrhosis or at for patients.
Bill: As noted on slide 12. These studies will allow us to generate outcomes data years in advance of any potential competitor outcomes data expand our indication and further extend our leadership in Nash.
William J. Sibold: Maestro Nash Outcomes is an event-driven trial enrolling approximately 700 F4 patients with a composite primary endpoint that assesses conversion to decompensated cirrhosis. There is an even higher urgency to treat F4 patients because of their elevated risk of developing serious and costly liver-related complications. Data from this study is anticipated in the 2026-2027 timeframe, and an indication in the F4 patient population could double the opportunity for red dipper in the US. The Potential for Maestro NASH Outcomes trial is supported by data we've shown to date in 180 patients with compensated NASH cirrhosis studied in the Phase 3 Maestro NAFLD-1 and Maestro NAFLD-OLE trials.
Bill: Maestro Nash outcomes is an event driven trial enrolling approximately $700 for patients with a composite primary endpoint that assesses conversion to D. Compensated cirrhosis. There is an even higher urgency to treat at for patients because of their elevated risk of developing serious and costly liver related.
Bill: Complications.
Bill: Data from this study is anticipated in the 2026, 2000, 2007 timeframe and an indication in the F. Four patient population could double the opportunity for Reg differ in the U S. The potential for Maestro Nash outcomes.
Bill: Trial is supported by data we've shown today.
Bill: Date, and 180 patients with compensated Nash cirrhosis studied in the phase III Maestro Napoli, one and maestro Naphthyl OLED trials.
William J. Sibold: Before passing it over to Marty to cover the financials, let me wrap up with a brief summary of the launch. It's really remarkable how much we've accomplished in such a short period of time. We were able to achieve FDA approval in March with a best case label and a first-to-market medicine. We had product in the channel in April, and our teams are out in the field executing. The feedback we're hearing from our customers is overwhelmingly positive.
Bill: Before passing it over to Marty to cover the financials, let me wrap up with a brief summary of the launch it's really remarkable how much we've accomplished in such a short period of time.
Bill: We were able to achieve FDA approval in March with a best case label and a first to market medicine.
Marty: We had product in the channel in April and our teams are out in the field executing the feedback we're hearing from our customers is overwhelmingly positive. There is high interest they have the patients and their prescribing rates differ I'm really encouraged by the early progress so far and even more confident today in the blockbuster potential of this medicine.
Marty Deer: There is high interest, they have the patients, and they are prescribing Resdifera. I'm really encouraged by the early progress so far and even more confident today in the blockbuster potential of this medicine. I'll now turn the call over to Marty. Thank you, Bill.
Marty: I'll now turn the call over to Marty.
Marty Deer: So I'll provide a few highlights for the first quarter of 2020. As we discussed on the launch call, initial redifference shipments to our specialty distribution network began in, so we recorded no risk differentiated revenue. As Bill discussed, there is good momentum with the launch, and given the need to wire the system early on and our expectation for it to take 60 days on average to fill a prescription through the first six months of launch, we expect revenue to be weighted to the back half of the year, with modest sales in the second quarter.
Thank you Bill the press release, we issued earlier today contains our full financial results I'll provide a few highlights for the first quarter of 2024.
Marty: As we discussed on the lines call initial with different shipments to our specialty distribution network began in April that we recorded no in deferred revenue for the first quarter.
Marty: As Bill discussed it didn't mention with the lines and given the need to wired system early on and our expectation.
Marty: 60 days on average.
Marty: A prescription to the first six months of lines, we expect revenue to be weighted to the back half of the year with modest sales in the second quarter. We are still in the early days.
Marty Deer: We are still in the early days of the ReCIFRA launch, and we look forward to sharing more about our progress. R&D expenses for the first quarter of 2024 were $71 million compared to $62 million for the first quarter of 2020. This increase was related to the timing of manufacturing, headcount growth, activities in our medical affairs group, and stock compensation; we would anticipate a relatively steady level of R&D expense. SG&A expenses were $81 million compared to $16 million for the first quarter of 2023, and an increase sequentially from $47 million in the fourth quarter.
Marty: Different lines, and we look forward to sharing more about our progress in the coming quarter.
Marty: R&D expenses for the first quarter of 2024, it was $71 million compared to $62 million for the first quarter of 2023.
Marty: This increase was related to timing of manufacturing head count growth activities in our medical Affairs group and stock compensation expense.
Marty: We would anticipate a relatively steady level of R&D expense for the rest of the year.
Marty: SG&A expenses were $81 million compared to 16 million.
Marty: First quarter of 2023, and an increase sequentially from $47 million.
Marty: Fourth quarter of 2023.
Marty Deer: This significant increase is due to the scale up of our commercial operations in anticipation of the March FDA approval of Rosetta. We hired the field team in January and February, so the second quarter will be more. Moving to our balance sheet, we announce an oversubscribed public offering that grossed $690 million for the company to further strengthen our financial are net cash found as of March 31, 2024, so that $1.1 billion. Note that the green shoot from the offering was executed in early April, and therefore an additional $86 million in net cash will be recognized in the second quarter.
Marty: This significant increase.
Marty: We expect it.
Marty: The scale up of our commercial operations in anticipation of the March FDA approval.
Marty: We hired the sales team in January and February of the second quarter will be more reflective of a full quarter of spend.
Marty: Moving to our balance sheet, we announced.
Marty: Oversubscribed public offering that growth $690 million for the company and further strengthen our financial position our net cash balance as at March 31st 2024 at $1 1 billion note that the green shoot from the offering was executed in early April and therefore, an additional $86 million in net cash.
Marty: That will be recognized in the second quarter, we are fully resource to support it.
Tina E. Ventura: We are fully resourced to support a successful, multi-year launch of our, Now, I'll turn the call back. Thanks, Marty. Let's move into the Q&A portion of the call. We'd ask that you limit your questions to one as our goal is to wrap up the call by 8:45. So Lisa, please provide instructions for the q&A session. Thank you. If you would like to ask a question, please press star 11 on your telephone; you will then hear an automated message advising that your hand has been raised. We also ask that you please wait for your name and company to be announced before you proceed with your question. One moment while I pop up a Q&A box.
Marty: Multiyear launch.
Speaker Change: Is that right.
Speaker Change: Now I'll turn the call back over to Tina Thanks, Marty, let's move into the Q&A portion of the call. We'd ask that you limit your questions to one as our goal is to wrap up the call by age 45. So Lisa please provide instructions for the Q&A session.
Lisa: Thank you.
Speaker Change: If you would like to ask a question. Please press star one on your telephone.
Speaker Change: We'll then hear an automated message our buys and Thats Youre Hamilton Lane.
Lisa: We also ask that you. Please wait for your name and company to be announced before you proceed with your question one moment, while compile the Q&A roster.
Operator: Our first question today will be coming from Yasmin Tamani of Piper Sandler. Your line is open. Good morning, team.
Lisa: Our first question, probably coming from Jasmine Hemani.
Piper Sandler: Piper Sandler your line is open.
Yasmeen Rahimi: Thank you for the updates. And maybe before I go, before I go with my question, I want to express my sincere condolences to you and the entire team of Madrigal for Dr. Stephen Harrison. He will be greatly missed for what he has done for the space. On my question, I guess, team, it would be wonderful if you could maybe highlight whether there is heterogeneity in the pair discussions or if it seems that the majority of the pairs are aligned in terms of their requirements for just simple blood tests, and you could just talk about how many pairs you have spoken to with heterogeneity, etc. And I'll move back into the queue.
Jasmine Hemani: Good morning team. Thank you for the update to maybe forego quango with my question want to express my sincere condolences to you and the entire team of macrocarpa, Dr. Stephen Harrison here will be greatly missed.
Jasmine Hemani: What have you done for the space.
Speaker Change: On my question I guess.
Speaker Change: <unk> would be wonderful if you could maybe highlight.
Speaker Change: Whether there is heterogeneity in the Paris discussions or is it seems that majority of the pairs are aligned in terms of their requirement.
Speaker Change: Simple block.
Speaker Change: So if you could just talk about how many payers you have spoken with the heterogeneity et cetera, and I'll move back into the queue.
William J. Sibold: Thanks, yes. Thanks for the question. Thanks for the comments about Stephen.
Speaker Change: Thanks, Ken Thanks, Jeff Thanks for the question and thanks for the comments about Stephen.
Speaker Change: Regarding the payer discussions.
Speaker Change: First of all I think it's still really early were out having conversations I remember we've been having conversations for a year with the Payors and I can tell you some of the themes. Some of the themes are first of all from a clinical perspective.
Speaker Change: Tremendous interest in red differ in Nash people are aware of the unmet need there were very aware of the payers are the costs that Nash patients have two down.
William J. Sibold: Regarding the payer discussions, first of all, you know, I think it's still really early. We're out having conversations. Remember, we've been having conversations for a year with the payers, and I can tell you some of the themes.
Speaker Change: So great interest in learning about the product learning about our outcomes.
Speaker Change: Learning about our approach and the reason why I say the approach.
Speaker Change: Resonated very well with payers is the fact that we're focusing on 315000 patients. We are focused on those that are diagnosed that are in the office.
William J. Sibold: Some of the themes are, first of all, from a clinical perspective, there is tremendous interest in res different in Nash; people are aware of the unmet need, they're very aware of the payers and the cost that Nash patients have to them. So there is great interest in learning about the product, learning about our outcomes, just learning about our approach. And the reason why I say the approach, which resonated very well with payers, is that we're focusing on 315,000 patients.
William J. Sibold: We are focused on those that are diagnosed and in the Office of Specialists, which is also important for them. So that has been the starting point of all of our conversations. And, you know, whether it be a regional or national player, we're out meeting with them. P&T committee meetings have been scheduled.
Speaker Change: <unk>, which is also important.
Speaker Change: Them.
Speaker Change: That has been the starting point of all of our conversations and whether it be a regional or national player.
Speaker Change: Meeting with them PMT Committee meetings have been scheduled we're getting some reads early on as you as you heard in the prepared remarks, we're at about 30% of covered lives now commercial covered lives.
William J. Sibold: We're getting some reads early on, as you heard in the prepared remarks. We're at about 30% of covered lives now, commercially covered lives. Well, on the way to our target of 80% by the year end. And I would say that at this point, there are no real surprises that we're having in these conversations, especially with the bigger plans. You know, we expect to get this resolved. Patients are still getting drugs. That's really the great thing.
Speaker Change: Well on the way to our target of 80% by the year end.
Speaker Change: And I would say that at this point.
Speaker Change: No real surprises.
Speaker Change: We are having in these conversations, especially with the bigger with the bigger plans. We expect to get this resolved patients are still getting drug. That's that's really the great thing. While this is going on patients are moving through we're getting prescriptions.
William J. Sibold: While this is going on, patients are moving through. We're getting prescriptions. Prior authorizations are required, a medical necessity in some cases.
William J. Sibold: So, you know, right where we are right now is where I would expect to be. I'm happy with 30%. We're well on the way to 80%. There are always going to be some old liars that I talked about even before we launched.
Speaker Change: Higher authorizations are required medical necessity in some cases, so right, where we are right now is where I would expect the debate I'm happy with 30%, we're well on the way to the 80%.
Speaker Change: Theres always going to be some outliers.
Speaker Change: I talked about even before we launched.
William J. Sibold: We're seeing a little bit of that, but that's certainly by no means... Thanks, yes. Lisa, next question, please. Thank you. And our next question is coming from Ellie Merle of UBS. Your line is open.
Speaker Change: Seeing a little bit of that but that's certainly by no means the trend great. Thanks, Yes, Lisa next question. Please.
Lisa: Thank you.
Lisa: And our next question is coming from Ellie Merle of UBS. Your line is open.
Eliana Rachel Merle: Hey guys, thanks for taking the question. You mentioned that 75% of prescriptions have been written by top targets. Can you give us any color on what proportion of your top physician targets have written a prescription? And then, just in terms of the prescriptions that have been written, can you give us any color on physician feedback on the medical exception process? And are most physicians going through medical exceptions at this point when they prescribe rosdifra?
Eliana Rachel Merle: Hey, guys. Thanks for taking the question.
Eliana Rachel Merle: 75% of prescriptions have been written by top targets.
Eliana Rachel Merle: Can you give us any color on what quick question on your top physician targets have written a prescription.
Eliana Rachel Merle: And then just in terms of our prescriptions have been.
Eliana Rachel Merle: Written can you give us any color on physician feedback on the medical exception process, most physicians going through the medical exceptions at this point, let me first of all thanks.
William J. Sibold: Thanks, Ellie. So on the latter, I would say that most are going through medical exception at this point. That's completely what we would expect.
Eliana Rachel Merle: Okay.
Speaker Change: So on the latter.
Speaker Change: I would say that most are going through medical exception at this point that's completely what we would expect in fact, if any are going through medical exception that would be more of a surprise because there just isn't the established pathways yet.
William J. Sibold: In fact, if any aren't going through medical exception, that would be more of a surprise because, you know, there just aren't the established pathways. So just to give you the layout, the prescribers, and where we're seeing, where we're focusing, and where we are, The Universe of Physicians is about 14,000. Our target physicians are about 6,000. And that's where we say that we've seen, we've had great success in seeing those physicians; the reps have been out and had interactions, sometimes, you know, a couple or three interactions with those high prescribers.
Speaker Change: So just to give you the layout the prescribers.
Speaker Change: We are seeing.
Speaker Change: We're focusing on what we're seeing.
Descriptions so the universe of physicians is about 14000.
Speaker Change: Our target for.
Speaker Change: Physicians are about 6000 of that and Thats, where we've said that we've seen.
Speaker Change: <unk> had great success in seeing those physicians the reps have been out and.
Speaker Change: <unk> had interactions sometimes.
William J. Sibold: We, and this is exactly what you'd expect in any launch, is that those target physicians should drive the majority of your prescriptions. And in this case, you know, we're really encouraged by 75% of the prescriptions from that group. You know, we haven't said how many have prescribed them or anything yet, but you know, these are all some stats as we get further along into the launch. I mean, again, we've only had the product out in the market for less than a month.
Speaker Change: A couple or three interactions with those high prescribers.
Speaker Change: We.
Speaker Change: And this is exactly what you'd expect in any launch is that those target physicians should drive the majority of your prescription in this case, we're really encouraged by the 75% of the prescriptions coming from that from that group.
We haven't said, how many have prescribed or anything yet, but these are all some stats as we get further along into the launch I mean again, we've only had product out in the market for less than a month, it's still really really early and difficult to project from such a short period of time, but all leading indicators and that's why we went with the leading <unk>.
William J. Sibold: It's still really, really early and difficult to project from, you know, such a short period of time, but all the leading indicators, and that's why we went with the leading indicators, are very supportive of things going really, really well. Great. Thanks, Ellie.
Speaker Change: Indicators are very supportive of things going really really well for us.
Liisa Ann Bayko: Liisa, next question, please. Thank you. And our next question will be coming from Liisa Bayko of Overcore. Your line is open.
Speaker Change: Great.
Speaker Change: Thanks Ali at least the next question. Please thank you.
Speaker Change: And our next question will be coming from Lisa Banco <unk>. Your line is open.
Liisa Ann Bayko: Hi, thanks for taking the question. I wanted to ask about the VA along the lines of an earlier question about heterogeneity and wanted to understand their requirement for a liver biopsy. Can you talk about how you interpret that, what you can do to improve that, and also what percentage of the 315,000 patients are part of the VA? Thank you so much.
Lisa Banco: Hi, Thanks for taking the question.
Lisa Banco: I wanted to ask about.
Lisa Banco: The VA along the lines up on an earlier question about heterogeneity.
Lisa Banco: I wanted to understand their requirement for a liver biopsy and can you talk about.
Lisa Banco: How do you interpret that what you can do to lift that and also what percentage of the 315000 patients are part of the VA. Thank you so much.
William J. Sibold: Thanks for the question, Liisa. And you know, look, the VA is pretty particular, right? In that if you're going to launch a product inside of a budget year, it's difficult because they have a fixed budget. And that requires congressional approval every year.
Speaker Change: Thanks for the question Lisa look the VA is pretty particular, right and that if youre going to launch a product.
Lisa Banco: Inside of a budget year its difficult because they have a fixed budget and that requires congressional approval every year, so any changes to the budget.
William J. Sibold: So any changes to the budget are actually kind of problematic. So, you know, look, we are disappointed in the decision. It certainly isn't great for patients.
Lisa Banco: Actually kind of problematic for them. So look we are disappointed in the decision.
Lisa Banco: Certainly isn't great for patients.
William J. Sibold: It certainly is counter to any guideline that's been written anywhere that says the use of NITs is adequate. And that's certainly what we believe in the field. So, however, you know, the facts are the facts. That's where we are at this point. Now, as we look forward to twenty five and it's a new budget year, you know, we're going to be working with the VA to have that corrected. You know, we think that certainly the guidelines, and the medical community, and certainly the patient community are on our side to have that happen. But you know, this is just one of those things, as I said, during the 12 months that you're wiring the system, sometimes you have to rewire portions of it.
Lisa Banco: It certainly is countered any guideline thats been written anywhere that says the use of <unk>. It is adequate and that's certainly what we believe the field is so however.
Lisa Banco: The facts are the fact that that's where we are at this point now as we look forward to 'twenty five and that's a new budget year, we're going to be working with.
William J. Sibold: And in this case, this is one of those examples where, based on the number of those reasons, where we find that that's the decision that they make sense of the. Sorry, Lisa, just jumping in terms of the number of patients that the VA covers, it's very small. So when we do a product mix, and we have that 10% that's Medicaid and VA patients. Okay. Thanks, Lisa.
Lisa Banco: The VA to have that.
Lisa Banco: Corrected.
Lisa Banco: We think that certainly be guidelines.
Lisa Banco: And the medical community and certainly the patient community is on our side to have that happen. But this is just one of those things as I said for the 12 months that youre wiring. The system, sometimes you have to rewire portions of it and in this case. This is one of those examples where just based on the number of those reasons.
Lisa Banco: We find.
Lisa Banco: That's the decision that they made.
Speaker Change: Yes, it makes sense.
Speaker Change: Okay.
Speaker Change: It's interesting in the terms of the number of patients that may be a temporary thing.
Speaker Change: All right perfect that when we do a product mix that we have that 10% that's Medicaid Anda cases.
Speaker Change: It's in the single digits.
Speaker Change: Not a large impact.
Speaker Change: Exited 24, okay. Thanks.
Speaker Change: Thanks Lisa.
Speaker Change: Tom.
Operator: Lisa, next question, please. Thank you. And our next question is coming from J. Oppenheimer. Your line is open.
Speaker Change: Lisa next question. Please thank you.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: And our next question is coming from Jay Olson of Oppenheimer. Your line is open.
Jay Olson: Oh, hey, congratulations on the launch progress. And thanks for taking the question. Can you just talk about some of the work you're doing to prepare for launch in the EU? And also, what your strategy is for launching in the EU, and how that may impact your operating expenses?
Jay Olson: Oh, Hey, congrats on the launch progress and thanks for taking the question.
Jay Olson: Can you just talked about some of the work you're doing to prepare for launch in the EU.
Jay Olson: And also how would your.
Jay Olson: <unk> is launching in the EU and how that May impact your operating expenses. Thank you.
William J. Sibold: Thank you. Okay, Jay, thanks for the question. You know, we're really excited.
Jay Olson: Okay. Jay Thanks for the question, we're really excited.
Speaker Change: In the call about.
Jay Olson: The opportunity to expand geographically and the EU is certainly a very interesting market for us.
William J. Sibold: We said in the call about the opportunity to expand geographically, and the EU is certainly a very interesting market for us. We're, you know, we announced in the first quarter, obviously, that we had filed, and we're now working through the strategy for the EU. And, you know, what we're looking at, and this is the way we make all decisions in the company, we're looking at one, three, five years from now. And where do we want to be? Where are we today?
Jay Olson: We announced in.
Jay Olson: The first quarter, obviously that we had filed we're now working through the strategy for the EU and what we're looking and this is the way we're making all decisions in the company. We're looking at 135 years from now and where do we want to be where are we today. The realities of where we are today versus what we think we're going to grow and become.
William J. Sibold: The realities of where we are today versus what we think we're going to grow and become. We want to be the leading company in that. We think that's achievable. And we think that, obviously, that's going to come not only through RISDFRA, but we'll develop a pipeline, and that's going to be geographic. Transcripts provided by Transcription Outsourcing, LLC. The only comment I would make, Jay, is that we are early in our decision making there and mapping out the expenses. The investment that we would make the payback on would be within one to two years.
Jay Olson: We want to be the leading company in Nash period, we think Thats achievable and we think that obviously, that's going to come not only through red differ but we will develop a pipeline and that's going to be geographic.
Jay Olson: Expansion as well so we're working through those details a little early for US to report out on them will come back to you on a later call.
Jay Olson: Be more specific about what we're doing in Europe, but it's exciting moment for us to be able to expand globally and we look forward to reporting out to you on it.
Speaker Change: Yes, the only comment I would make take because we are early in our decision, making there and mapping out the expenses that the investment that we would make that payback.
William J. Sibold: That's how we look at, you know, our strategic plan. So there would be an impact, likely if we get approval on 25, that and that's just looking at your. Clearly, the U.S. launch will cover a lot of the spend there in the, Great. Thanks, Jay. Liisa, next question, please. Thank you. And our next question is coming from Ritu Baral of TD Collins. Your line is open.
Speaker Change: It would be within that one to two years, that's how we look at our strategic decision, making so it would be an impact likely if we get approval in 'twenty five.
Speaker Change: Great. Thanks.
Speaker Change: Okay.
Speaker Change: Just looking at you specifically the U S launch will cover a lot of that.
Speaker Change: Great. Thanks, Jay.
Speaker Change: Next question. Please thank you.
Speaker Change: And our next question is coming from Richard Ball.
Richard Ball: Tom Your line is open.
Ritu Subhalaksmi Baral: Good morning, guys. I want to dig in a little further about the non-invasive algorithm for pre-authorization that may be coming together in your insurance discussion. You know, per Yasmeen's question, are you finding that things are mostly blood-based?
Richard Ball: Good morning, guys.
Richard Ball: Can you dig in a little further about the noninvasive algorithms for Preauthorization that may be coming together insurance discussion.
William J. Sibold: Are you finding that there's a blood base plus imaging, and which imaging is being preferred? And then how could that ultimately affect time to fill, or how could that be affected by ASLB guidelines? Thank you. Ritu, thank you very much for the question. I really appreciate it.
Richard Ball: Yes.
Richard Ball: <unk> question are you finding Bob things are mostly blood based are you finding that.
Richard Ball: There was a blood based plus in imaging.
Richard Ball: Which imaging, it's being preferred and then how could that ultimately affect time to fill or how could these be affected by a healthy pipeline. Thank you.
William J. Sibold: And look, I, you know, it's still early in the process. Generally, payers are evaluating a menu of the NIH. There isn't 100% consistency across, and I think, you know, you've heard me mention the community is still working through what's the best sequence, what's the best combination of NITs. I think that the guidelines, you know, have started to help with that. I think, you know, the pending guidelines will hopefully again provide additional comments on NITs.
Speaker Change: We do thank you very much.
Speaker Change: For the question really.
Speaker Change: I appreciate it and look.
Speaker Change: It's still early in the process.
Speaker Change: Generally payors are evaluating a menu of the entities.
Speaker Change: There isn't 100% consistency across and I think you've heard me mentioned, even the community is still working through what's the best.
Speaker Change: Sequence, what's the best combination of Ni.
Speaker Change: The guidelines have started to help with that I think pending.
Speaker Change: Pending guidelines will hopefully again provide.
William J. Sibold: Regarding the availability, and I think you kind of hinted at that, we don't see that as a limitation at the moment. Certainly, any of the decisions that we've seen, the physicians in the area certainly seem to have access to those types of NITs. Between blood and imaging, you know, I would say it's typically a combination of blood and imaging.
Speaker Change: Additional.
Speaker Change: Comments on <unk>.
Speaker Change: Regarding the availability and I think you've kind of hinted to that we don't see that as a limitation at the moment.
Speaker Change: Any of the decisions that we've seen.
Speaker Change: Physicians in the area certainly seem to have access.
Speaker Change: To those types of entities between blood and imaging.
Speaker Change: <unk>.
Speaker Change: I'd say its typically a combination.
Speaker Change: Blood and imaging.
Speaker Change: But as we have more final decisions and have trends, we will be able to report out to you what that looks like.
William J. Sibold: But, you know, as we have more final decisions and we have trends, we'll be able to report out to you what that looks like. We're really excited about updated guidelines. We know the community is working on them. You know, I think one of the things we have to remember is that the guidelines are pretty set. What you need to do now is put ResDiffra into those.
Speaker Change: We're really excited about updated guide.
Speaker Change: <unk>.
Speaker Change: Though the community is working on them.
Speaker Change: I think one of the things we have to remember.
Speaker Change: The guidelines are pretty set what you need to do now is put different into those guidelines. So we're not expecting while differences, where just a they've been void of a treatment before now youll be able to put risk different in there but.
William J. Sibold: So we're not expecting wild differences. We're just a, they've been void of treatment before. Now you'll be able to put RISDiffer in there.
William J. Sibold: But, you know, so I guess the conclusion is still early. We're seeing the gamut, if you will, of NITs, and it doesn't, Barrier, to access to these where the decisions have been made, so physicians can test them. And this will be a continued to evolve field as I think the community kind of really, now that they have a product, thanks for giving them ideas about how to use NITs, how to sequence
Speaker Change: So I guess conclusion is still early.
Speaker Change: We're seeing.
Speaker Change: The gamut, if you will of NIH.
Speaker Change: And it doesn't appear.
Speaker Change: Year to be any kind of.
Speaker Change: Barrier.
Speaker Change: To access fees in that where the decisions have been made so physicians can test them and this will be a continued to evolve field as I think the community kind of really now that they have a product.
Speaker Change: Thinks about how to use and it had a sequencing combined great. Thanks, you too Lisa next question. Please.
William J. Sibold: Thanks, Ritu. Liisa, next question, please. Thank you. And our next question will be coming from Thomas Smith of Levery Partners. Your line is open. Hey, guys. Good morning.
Speaker Change: Thank you.
Lisa Banco: And our next question will be coming from Thomas Smith of Leerink Partners. Your line is open.
Thomas Jonathan Smith: Thanks for taking the questions and congrats on the early launch progress. I wanted to follow up on some of the early payer coverage and specifically on the VA decision. Do you expect this will have any read-through to how any other commercial or government plans are likely to cover res difra, at least with their initial coverage policy decisions? And then how important are updates to the treatment guidelines with respect to payer discussions?
Thomas Jonathan Smith: Hey, guys. Good morning, Thanks for taking the questions and congrats on the early launch progress I wanted to follow up on some of the early payer coverage and.
Thomas Jonathan Smith: Specifically on the VA decision.
Thomas Jonathan Smith: We expect this will have any read through to any other commercial organic plans are likely to cover what's different at least with their initial coverage policy decisions and then.
Thomas Jonathan Smith: How important are updates to the treatment guidelines with respect to the payer discussions have you received any feedback from payers, suggesting that this could help drive either more favorable coverage or less restrictive prior off coverage. Thanks.
Thomas Jonathan Smith: Have you received any feedback from payers suggesting that this could help drive either more favorable coverage or less restrictive prior auth coverage? Thanks. Right, Thomas, thanks for the question. You know, first of all, don't think there's a read through there.
William J. Sibold: You know, we're having independent conversations with each payer. And as I said, with the payers, especially the larger players that we're that we're speaking with, there is a true, true acceptance of Unknown Executive, Remy Sukhija, Madrigal Pharmaceuticals Inc. And the second question was... The guidelines.
Speaker Change: Great Thomas Thanks for the thanks.
Speaker Change: Thanks for the question.
Speaker Change: First of all.
Speaker Change: Think there's read through there.
Thomas Jonathan Smith: Having independent conversations with each payer and as I said with the payers, especially the larger players that were there that were speaking with there is a true true.
Speaker Change: Acceptance of the seriousness of the disease.
Speaker Change: And appreciation for the clinical data and an appreciation for how we're approaching the launch so I think that there that they are independent decisions I mean people.
Speaker Change: Payors.
Speaker Change: All make their own independent decisions. So we don't we don't see the read through and the second question was you guys. The guidelines, but I think the guidelines are important.
William J. Sibold: Look, I think the guidelines are important. And, you know, as I said in the previous question, the guidelines that are in place are already being referred to. I think it would be helpful for the physician community and the payer community, though, to have updated guidelines that do contemplate res diffra and provide a little bit more direction about, you know, how you would use it, when you would use it, etc. So, you know, we know that the various bodies are working on it, and we're hopeful that we'll see at least a draft in the not too distant future. Great. Thanks, Tom.
Speaker Change: I said in the previous question. The guidelines that are in place are already being referred to I think it will be helpful for the physician community and the payer community, though to have updated guidelines that do contemplate red differ and provide a little bit more direction about how you would use it when you would use it.
Speaker Change: Et cetera, So we are and we know that the various bodies are working on it.
Speaker Change: We're hopeful that we will see at least something draft.
Speaker Change: Not too distant future.
William J. Sibold: Next question, please, Liisa. Thank you. And our next question will be coming from Akash Tiwari of Jefferies. Your line is open. Hey, thanks so much.
Speaker Change: Great. Thanks, Tim next question. Please Lisa Thank you and our next question.
Lisa Banco: We will be coming from a cash to Raleigh of Jefferies. Your line is open.
Akash Tewari: So do we have any early color on the patient enrollment forms? Are they exceeding your internal expectations? And when we think about rewiring the system, Phil, you previously indicated we should not expect to see any significant revenues for Res Diffra in 2024. Is that still the case?
Cash: Hey, thanks, so much but do you have any early color on the patient enrollment.
Lisa Banco: Formed are they exceeding your internal expectations and when we think about rewiring of the system.
Raleigh: We indicated we should not expect to see any significant revenues to resume in 2024 is that still the case I just wanted to make sure. We're clear on what expectations are going to be and then maybe if I could sneak this in some of the tight shows a fibrosis benefit that's in line with Brett Roth and its upcoming Phase III trial do you expect you hope you wanted.
William J. Sibold: I just want to make sure we're clear on what expectations are going to be. And then, maybe if I could sneak this in, if semaglutide shows a fibrosis benefit that's in line with res diffra and its upcoming phase three trial, do you expect ULP to be step added by payers ahead of your product? And would that affect your internal launch projections for next year? Thank you. Okay, thank you. Thank you for the questions. Let me see if I can get through them all here.
Raleigh: To be step added by payers ahead of your product and would that affect your internal projections for next year. Thank you.
Speaker Change: Okay. Thank you. Thank you for the question, let me see if I could if I can get through them all here.
William J. Sibold: Look, we aren't providing anything with patient numbers or Initiations or anything at this point. This is just too early. You know, I think I was pretty clear in the call that I'm really pleased with the way things are progressing with the launch. Our focus right now is really wired the system. If we don't build a strong foundation.
Raleigh: Look.
Speaker Change: We arent, providing anything with patient numbers or.
Speaker Change: Initiations or anything at this point, it's just it's just it's just too early.
Speaker Change: I think it's pretty clear in the call that I'm really pleased with the way things are progressing with the launch our focus is right now is really this wiring the system. If we don't build a strong foundation.
William J. Sibold: We will not be able to push through high volumes of patients. A lot of companies make the mistake that they just try to chase, you know, getting patients on drugs without preparing the practice. Payers and the whole system for being able to handle the flow, and we're focusing on that. However, we are still having patients come through, which is really great. So I'm very pleased where we are. I'm looking forward to, as we get through the next quarters, being able to further wire and also to give you a report on just how things are going. Your next question was about the expectation for revenue. Oh, the expectation for revenue. Marty, do you want to take this one?
Speaker Change: We will not be able to push through high volumes of patients in the future a lot of companies make the mistake that they just try to chase getting patients on drug without preparing the practice.
Speaker Change: Payers and the whole system for being able to handle the flow and we're focusing on that however, we are still having patients come through which is really great. So I'm very pleased where we are.
Speaker Change: Looking forward to as we get through the next quarters of being able to further wire and also to give US a report out on just how things are going.
Speaker Change: Your next question was about the expectation for revenue no expectation for Evian, Marty you want to take that one.
Marty Deer: So, Akash, just to be really clear what we said, said because of the time to wire the system and the time for https://www.globalonenessproject.org that the Q sale will be and that the sales for the year will really be back and loaded for Q3. We haven't given a number for that. We haven't given guidance on that, but we are, we have validated the data, and where the streak is as an average or consensus that we feel. So that's the message regarding
Marty: So okay.
Marty: Let's be really clear, what we said, we said because of the time to wire it system and the time for.
Marty: Prescriptions to be filled.
Marty: Six months, which we estimate on average 60 days, we think that comes down to 30 days after six months that two cube payout will be modest.
Marty: And that.
Speaker Change: Sales for the year will really be backend loaded for Q3 and Q4, we haven't given the numbers that we haven't given guidance on that but we are.
Speaker Change: We have validated that.
Speaker Change: <unk> is as an average of consensus that we feel confident with that.
Speaker Change: That's the message regarding revenues for 2024.
William J. Sibold: I think, look, you know, I guess we'll find out more this year about if anyone manages to show the same impressive efficacy results that we have by hitting on both primary and secondary. You know, let's see. So, looking ahead to the future, regardless of what happens, what they show, I think you have to go back to the facts. The facts are, first of all, that there is an incredibly high impact.
Speaker Change: With the.
Speaker Change: I mean look.
Speaker Change: I guess, we'll find out more this year, but if anyone.
Speaker Change: Manages to show the same.
Speaker Change: <unk> efficacy results that we have by hitting on both primary endpoints.
Speaker Change: Let's see so looking ahead to the future.
Speaker Change: Regardless of what happens what they show I think you have to come back to come back to the facts.
Speaker Change: The facts are first of all that there is an incredibly high unmet need there's 315000 patients. So there's a lot of patients.
William J. Sibold: 315,000 patients, so there are a lot of patients. And up until March 14th, there was not an approved therapy. Now, what was the therapy that was approved? Res Diffra, and look at that profile. Efficacy, hit on both endpoints, greater than 80% of patients. Stop or reverse fibrosis.
Speaker Change: And up until March four I think there was not an approved therapy now what was the therapy that was approved <unk> different and look at that profile efficacy hit on both endpoints greater than 80% of patients have a.
Speaker Change: Stop or reverse fibrosis. So the response is deep.
William J. Sibold: So the response is D, and the responses. So we have an effective product that happens to be a once-a-day pill that has been shown to be well-tolerated and safe. So we've got a profile which is really a fantastic profile. I mean, it's every kind of drug maker's dream to have a once-a-day pill for a serious disease. And, you know, I'll take that profile, and we will compete against anyone, especially since we're at the beginning of a market. We're not talking about a zero-sum game here where market shares are all locked in place, and one person's going to lose share; one person's going to gain it.
Speaker Change: And the response is wide.
Speaker Change: So we have.
Speaker Change: Effective product.
Speaker Change: That happens to be a once a day pill that.
Speaker Change: Has been shown to be well tolerated and safe.
Speaker Change: We've got a profile, which is really a fantastic profile I mean, it's every day.
Speaker Change: Drug makers dream is to have a once a day pill for a serious disease and.
Speaker Change: I'll take that profile and we will compete against anyone especially since we're at the beginning of a market. We're not talking about a zero sum game here where market shares are all locked in place and one person is going to lose share one person is going to gain it.
William J. Sibold: You know, we're hopeful that there are going to be other products in NASH because it helps to grow the market, and we think that with our approach, which is still emerging. Look, we only had, we got approved on 52 week data, and we saw this as a 54 month study. We think, you know, some of our best days are ahead of us in showing what this product can do. But will they force a product, force a patient to go through GLP-1? I don't know.
Speaker Change: We're hopeful that theres going to be other products in Nash because it helps to grow the market and we think that with our profile, which is still emerging look we only have we got to prove the 52 week data and we saw this is a 54 month study we think some of the our best days are ahead actually in showing what this product can do so will be forced a product.
Speaker Change: First the patient to go through a <unk> one.
Speaker Change: I don't know.
William J. Sibold: You know, we'll see what they do, but I think that on our profile alone, there is a very compelling reason for patients to be on. So we're extremely confident under any scenario of what any. Thanks, Aakash. Liisa, next question, please.
Speaker Change: We'll see what they do but I think that on our profile alone.
Speaker Change: There is a very compelling reason.
Speaker Change: For patients to be on rent is different so we're extremely confident under any scenario of what anyone else Jones data great. Thanks for cash at least the next question. Please thank you.
Operator: Thank you. And our next question will be coming from John Walleman of Citizen. Your line is open.
Speaker Change: And our next question will be coming from John Walden.
John Walden: Citizens Your line is open.
Jonathan Patrick Wolleben: Hey, thanks for taking the question. I was wondering if you talked about the patient services you're providing and if you're expecting patients to start on paid therapy after that 60 to 30 days or if there's going to be a lot of free drugs in the system. Okay, so John, thanks for the question. Do you mean the types of services that we're going to offer, or do you want more specifically how we see that mix of patients? I guess the latter is more informative, but it would be good if you could speak to the former as well.
John Walden: Hey, Thanks for taking my question I'm wondering if you could talk about the patient services, you are providing and if youre expecting patients to start on therapy. After that 6% to 30 days or if theres going to be a lot of free drug.
Speaker Change: In the system.
Speaker Change: Okay. So.
Speaker Change: John Thanks for the question you mean, the types of services that we're going to offer already won more specifically, how we see that mix of.
John Walden: Mix of patients.
Speaker Change: I guess, the ladders more informative, but if you could speak to the first part of the former as well.
William J. Sibold: Yeah, look, we've put together a very comprehensive patient support group. We think that's really important. We think it's important that the first interaction that they have with the product through patient support is important and establishes kind of a long-term relationship, hopefully helps them navigate any challenges they may have along the way. Through Madrigal patient support, they get co-pay assistance, etc.
John Walden: Yes look so we've put together a very comprehensive.
Speaker Change: Patient support.
Speaker Change: Group.
Speaker Change: We think that's really important.
Speaker Change: We think it's important that the first interaction that they have with the product through patient support is an important and establish as kind of a long term relationship hopefully helps them navigate any challenges they may have along the way.
Speaker Change: Through magical patient support they get co pay assistance et cetera.
Speaker Change: If they are underinsured or have no insurance they can qualify potentially for our patient assistance program to receive free drug et cetera. So.
William J. Sibold: If they are underinsured or have no insurance, they can potentially qualify for our patient assistance program to receive free drugs, etc. So it's important not only on the front end but also as you look over the long term, establishing that long-term relationship and, you know, helping through any kind of adherence challenges. So we fundamentally believe that a strong patient support services group is important, and we think that we've got a really great one that we've started.
Speaker Change: It is important not only on the front end, but also as you look over the long term establishing that long term relationship and.
Speaker Change: Helping through any kind of adherence challenges somebody may have so we fundamentally believe that a strong patient support.
Speaker Change: Services group is important and we think that we've got really a great one.
Speaker Change: We started rigs.
William J. Sibold: Regarding kind of free drugs and so forth, you know, look, you've heard me say before that as you look through kind of that first year, you've got patients that are some are going to be on free drugs will have a big bridging program, etc. So it's a little bit choppy if you're thinking of it from a gross to net perspective for that first year. But what we've committed to the community is this whole notion of equitable access. We don't want to, we want to be able to provide this product to patients who need it. So we've focused on affordability for patients. If you're a commercial patient, you can have a $10 copay.
Speaker Change: Regarding kind of.
Speaker Change: Free drug and so forth.
Speaker Change: Sure.
Speaker Change: You've heard me say before that as you look through kind of that first year you have got.
Speaker Change: Patients that are some are going to be on free drug will have a big bridging program et cetera. So it's a little bit choppy, if youre thinking of it from a gross to net perspective for that first for that first year.
Speaker Change: What we've committed to the community is this whole notion of equitable access.
Speaker Change: We don't want to.
Speaker Change: We want to be able to provide products to patients who need it. So we've focused on affordability for patients if you're a commercial patient you can have a $10 co pay.
William J. Sibold: You know, the challenge right now is with Medicare; since we missed the window for 24, we're now talking about what will happen in 25. So those Medicare patients are either going to have an opportunity through their own plan if they've made a mid-year decision, or some of them are going to have to wait for 2025. So we're going to try to help those patients; we'll look to see if there are alternatives for them, such as charitable foundations, etc.
Speaker Change: The challenge right now is with Medicare since we missed the window for 'twenty four we're now talking about what will happen in 'twenty five.
Speaker Change: So those Medicare patients are either going to have a opportunity through their own plan, if they've made a midyear decision.
Speaker Change: Some of them are going to have to wait for.
Speaker Change: 2025, so we're going to try to help those patients we will look to see if there is.
Speaker Change: Alternatives for them, such as charitable foundations et cetera, and in the end if they can get it through other means and they have a high unmet need we will provide free product. So we will have three patients, but that's not where we are to date, we have patients that are coming through the system and they are paid.
William J. Sibold: And in the end, if they can't get it through other means, and they have a high unmet need, you know, we'll provide a free product. So we will have free patients, but, you know, that's not where we are today. We have patients that are coming through the system, and they're paid for their prescriptions.
William J. Sibold: So we feel like we're in a really good place, but we're always going to have this balance of some patients, for structural reasons, won't be able to get drugs through that means we're going to help those patients. But we're going to try to keep things very much in sync between the various types of patients, whether you're insured, uninsured, commercial, or Medicare. So that kind of is a little bit of more flavor around it rather than a really specific number that I'm giving you. But, you know, expect all those components, especially as you'll see in this first kind of 12.
Speaker Change: So we feel like we're in a really good place, but we're always going to have this balance of some patients for.
Speaker Change: Structural reasons won't be able to get drugs through that means we're going to help those patients, but we're going to try to keep things in very much in sync between the various types of patients whether youre ensured uninsured commercial Medicare so.
Speaker Change: It kind of is a little bit more flavor around it rather than a real specific.
Speaker Change: Number that I'm, giving you, but expect all those components, especially youll see in this first 12 month period alright, Thanks, John at least it looks like we have time for one more question. Please okay one moment.
William J. Sibold: Thanks, Jen. Lisa, it looks like we have time for one more. Okay, one moment.
Operator: Our next question is coming from Andrea Tan of Goldman Sachs. Your line is open. Thanks for squeezing us in. Maybe one question here on the prescriptions that have come through. Just wondering if you're able to speak about the dynamics that you're seeing to date. Is that generally one prescription per specialist or maybe multiple prescriptions per specialist?
Speaker Change: Our next question coming from Andrea <unk> of Goldman Sachs. Your line is open.
Andrea: For squeezing us in maybe one question here on the prescriptions that have come through I'm, just wondering if youre able to speak about the dynamics that youre seeing today is that generally one prescription per specialist or maybe multiple prescriptions professionally. Thanks. So much.
Andrea R. Tan: Thanks so much. Thanks, Andrea. It varies, right?
Speaker Change: Thanks Andrea.
Speaker Change: It varies I mean, everyone starts with one so to speak or actually some of them started with more than that but.
Speaker Change: One of the things, we expect to see us in the top 6000 or this target 6000 is it's going to go beyond one and Theyre going to go pretty deep actually because we know they have the patients and we know that.
William J. Sibold: I mean, everyone starts with one, so to speak, or actually, some have started with more than that. But, you know, one of the things we expect to see in this top 6,000, or this target 6,000, is that it's going to go beyond one, and they're going to go pretty deep, actually, because we know they have the patient, that there's a lot of favorable belief about res difera. So over time, you know, we're gonna see again this notion of breadth and depth, and it's gonna be concentrated in that top 6,000. So it's still pretty early.
Speaker Change: There is a lot of.
Speaker Change: Favorable belief about rates differ.
Speaker Change: Over time, we're going to see again, this notion of breadth and depth and its going to be concentrated in that in that top 6000, So still pretty early I mean look again.
William J. Sibold: I mean, look, again, you know, with just, you know, what we found is that physicians, until drugs became available, weren't giving a lot of thought to how they were going to process all their patients, right? Now that drugs are available, they're making it part of their pathway in their practice. And that takes a little bit of time to think about how they're right, but we're really encouraged patients are being prescribed drugs patients are getting on drugs.
Speaker Change: With just what we've what we found.
Speaker Change: Is that the physicians until drugs available.
Speaker Change: We're giving a lot of thought to how theyre going to process all of their patients right now that drugs available theyre, making it part of their pathway in their practice and that takes a little bit of time to think how theyre going to do it right, but we're really encouraged patients are being prescribed patients are getting on drug.
William J. Sibold: So, you know, we're kind of fulfilling our promise. We're trying to change lives here. And it's really exciting. And, you know, maybe I'll just end on that and say, This is a really great and exciting opportunity. As you heard me say, I'm more excited about the opportunity now than I was six months ago or three months ago. And it's just, I can't tell you how much fun it is to be out there with a product that's so meaningful in a disease that has had absolutely nothing.
Speaker Change: No.
Speaker Change: We're kind of fulfilling our promise for trying to change lives here and it's really exciting and maybe I'll just.
Speaker Change: And on that and say.
Speaker Change: This is a really great and exciting opportunity as you heard me say im more excited about the opportunity now than I was six months ago or three months ago.
Speaker Change: It's just I can't tell you how much fun it is to be out there with a product that is so meaningful in a disease that has had absolutely nothing and we get to set the bar for all others that come.
William J. Sibold: And we get to set the bar for all others that. There's, you know, it's rare that you get an opportunity to be the first one to establish how you engage with companies. What's the expectation you set for patient services and everything along the way?
William J. Sibold: We have that opportunity as leaders, and our intent is to go out there and lead like leaders. You know, this is our first launch, but we have a really experienced team. We know what we're doing. We have the resources, we have the product, the opportunity is there. It just takes time to get it right, build the foundation as we wire the system, and we'll put ourselves in a great position to win and be the leader.
Speaker Change: It's rare that you get an opportunity to be the first one to establish how do you engage with companies. What's the expectations you set for patient services and everything along the way we have that opportunity at the leader and our intent is to go out there and we are leading like leaders.
Speaker Change: First launch, but we have a really experienced team we know what we're doing we have the resource we have the product the opportunity is there.
Speaker Change: Just takes time to get it right build the foundation as we wire the system.
William J. Sibold: And we will put ourselves in a great position to win and be the leader in this space.
Tina E. Ventura: Thanks, Andrea. And thanks, Liisa. And thank you all for your time and interest today. This concludes our call. A replay of the webcast will be available on our website in approximately two hours.
Speaker Change: Thanks Andrea.
Speaker Change: Thanks, Lisa and thank you all for your time and interest today. This concludes our call a replay of the webcast will be available on our website in approximately two hours. So thank you so much for joining us.
Operator: So thank you so much for joining us. Ladies and gentlemen, thank you for your participation in today's conference. You may now all disconnect. Have a wonderful day. Thomas Smith, Eliana Merle, Ritu Baral, Andrea Tan, Eliana Merle, Thomas Smith, Rebecca Taub, Alex Howarth, Unknown Executive, Remy Sukhija, Madrigal Pharmaceuticals Inc Thomas Smith, Eliana Merle, Rebecca Taub, Alex Howarth, Unknown Executive, Remy Sukhija, Madrigal Pharmaceuticals Inc, ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Thomas Smith, Rebecca Taub, Andrea Tan, Eliana Merle, Thomas Smith, Rebecca Taub, Alex Howarth, Unknown Executive, Remy Sukhija, Madrigal Pharmaceuticals Inc, Thomas Smith, Ritu Baral, Andrea Tan, Eliana Merle, Thomas Smith, Rebecca Taub, Alex Howarth, [inaudible] Thomas Smith, Eliana Merle, Ritu Baral, Andrea Tan, Eliana Merle, Thomas Smith, Rebecca Taub, Alex Howarth, Unknown Executive, Remy Sukhija, Madrigal Pharmaceuticals Inc, ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ??
Speaker Change: Ladies and gentlemen, thank you for your participation in today's conference you May now all disconnect have a wonderful day.
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