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CBO Ray Jordt expressed satisfaction with the trial's discontinuation rates and highlighted that weight loss is a key differentiator, benchmarking it against semaglutide's results adjusted for a 24-week timeline. CEO Dr. Vipin Garg confirmed they are strongly considering using the higher 2.4mg dose in Phase 3 to maximize weight loss and are also considering a 6-month endpoint to potentially accelerate the development timeline, pending FDA discussions.

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CEO Dr. Vipin Garg stated that the focus remains on the NASH Phase III program, with the new indications being relatively inexpensive options. CMO Dr. Scott Harris differentiated pemvidutide from competitors by highlighting its superior glucagon activity, liver defatting, and tolerability profile, noting the FDA did not require a cardiovascular safety trial. CBO Raymond Jordt mentioned progress on the oral formulation, stating they are nearing a commercially viable bioavailability.

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CMO Dr. Scott Harris firmly stated that cardiac issues are not a class effect, noting pemvidutide has shown no such signals across its trials and that the FDA agreed with this assessment, concluding the issue is likely compound-specific to survodutide. He confirmed the first new indication trial will launch in H1 2025, with the exact timing relative to the MASH readout to be determined. CEO Dr. Vipin Garg reinforced that no additional safety studies are required for pemvidutide.

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CEO William Lewis clarified that the addressable market figures are based on ICD-10 codes. He stated there are approximately 500,000 patients in the U.S. with a definitive diagnosis of bronchiectasis via CT scan. Of those, an estimated half, or around 250,000, have had two or more exacerbations in the last 12 months, representing the initial target population.

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CEO William Lewis clarified that the company's figures are derived from ICD-10 codes for patients with a definitive diagnosis and documented exacerbations. He stated there are roughly 500,000 diagnosed bronchiectasis patients in the U.S., and of those, about half have had two or more exacerbations in the last 12 months, representing the initial target population.

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CEO Will Lewis explained that the company's market access strategy is designed to prevent such requirements. By engaging in minor discounting and contracting, Insmed aims to establish a reauthorization process based on a physician's verbal attestation rather than specific clinical markers. He expressed confidence in this approach due to brensocatib's position as a first-in-disease, novel mechanism therapy.

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CEO Will Lewis characterized the chance of accelerated approval based on ARISE data as a "long shot" with a low probability (less than 25%), though it remains a prudent discussion to have with the FDA. CFO Sara Bonstein addressed the Japan performance, explaining that flat sequential revenue was due to working down favorable inventory from Q2, while underlying fundamentals remain strong with over 30% year-over-year growth.

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CFO Sara Bonstein explained that Japan's Q3 revenue was impacted by inventory dynamics after a strong Q2, but year-over-year growth was over 30% and fundamentals remain strong. CEO Will Lewis characterized the U.S. accelerated approval attempt as a 'long shot' with a low probability (<25%), but a prudent step to take with the FDA, acknowledging the most likely path to label expansion remains the full ENCORE data.

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CEO Emil Kakkis explained that cleaning and locking the international Phase III database is a lengthy process, estimating it takes around 8 weeks before analysis. He emphasized that because the full database is being prepared for a potential BLA, the time to see top-line data will be much faster than after the first interim. He left open whether the top-line announcement and subsequent data release would be simultaneous.

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CEO Emil Kakkis noted that their Phase II data showed a wide range of baseline fracture rates, from less than one to as high as seven per year, with younger patients tending to have more fractures. He emphasized that after treatment in Phase II, the majority of patients stopped having fractures completely, demonstrating a strong treatment effect despite the baseline variability.

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CFO Charlie Wagner explained that it was too early to provide specific gross-to-net details for JOURNAVX, as it is heavily impacted by patient assistance programs during the initial launch. He expects it to normalize as payer coverage expands through 2025 and into 2026. CEO Reshma Kewalramani described the initial 60,000-patient T1D population as the most severe cases with brittle diabetes, with plans to expand to broader populations later.

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CEO Reshma Kewalramani stated the goal is for JOURNAVX to be a first-line therapy for moderate to severe acute pain. COO Stuart Arbuckle added that they are seeking broad stocking in both retail and hospital channels. CFO Charlie Wagner noted that initial volumes will likely outpace revenue due to patient assistance programs during the access-building phase.

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COO Stuart Arbuckle cited policy efforts like the Alternatives to PAIN Act and direct payer engagement as key strategies. He acknowledged that some form of prior authorization may exist initially but emphasized that the goal is to prevent restrictive measures, such as requiring patients to first fail on an opioid, to make access as seamless as possible.

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Chief Commercial Officer Charlie Gayer expressed high confidence that the paid rate is 'very sustainable,' calling the current 84% a 'new floor' due to compelling real-world evidence influencing payers. He stated that out of about 10,000 U.S. HAE patients, 3,000 had tried ORLADEYO by the end of 2024, leaving a substantial pool of 7,000 patients for future growth. CEO Jon Stonehouse added that capturing one-third of the market already puts them firmly on the path to their $1 billion peak sales target.

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Chief Commercial Officer Charlie Gayer projected reaching the 85% paid rate over the next three years, identifying the impact of the IRA on Medicare patients as a 'big wild card.' He noted that their best-in-class patient services team is a key factor under their control. CEO Jon Stonehouse added that while the speed of improvement is unknown, the trend for Medicare patients is positive due to decreasing out-of-pocket costs.

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Chief Commercial Officer Peter Heerma explained that while a specific breakdown was not provided, the median proteinuria level at initiation is trending down and is now 'well below 1.5 gram per gram.' Regarding competition, he reiterated that FILSPARI's demand growth continued through April, and more market participants help raise awareness of the need to treat.

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CFO Chris Cline projected a gross-to-net in the high teens to low 20s for 2025, with the greatest impact in Q1. CCO Peter Heerma stated they have not seen issues with renewals and that payers are adopting the broader label. Regarding combinations, Heerma expressed confidence, citing FILSPARI's strong head-to-head data and value-based pricing, which positions it as a foundational therapy that payers are likely to accept in combination regimens.

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CEO William Sibold estimated that 25% of Rezdiffra patients are on a GLP-1, with 50% having prior exposure. CFO Mardi Dier addressed GTN, stating Q1 was favorable but is expected to increase throughout 2025 as payer contracting begins, remaining within the typical range for specialty drugs. Both executives emphasized a disciplined, long-term approach to GTN management.

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CEO William Sibold positioned Rezdiffra as having a superior profile for MASH due to its liver-directed mechanism, ease of use, and tolerability, suggesting semaglutide would expand the market, benefiting Madrigal as the leader. Dr. Michael Charlton explained that a 25% reduction in liver stiffness is highly predictive of a one-stage or greater improvement in fibrosis.

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CEO William Sibold addressed Europe, stating its market size is comparable to the U.S. and that it is more prepared for a launch. He also noted it's early for discontinuation data, but signs point to strong persistency. CFO Mardi Dier explained that gross-to-net was favorable due to low co-pay assistance use but expects it to increase in Q1 2025, while remaining within a typical range for specialty drugs, even with new competition.

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CEO John Leonard explained that while the relationship isn't strictly linear, attack rates drop sharply with significant kallikrein reduction. He noted that longer observation periods, as planned for Phase III, tend to show attack rates falling to very low levels as patients gain confidence. CMO David Lebwohl added that the longer follow-up in Phase III should also support better results.

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CFO Mark Ragosa stated the year-to-date gross-to-net was 9.8%. CCO Ross Moat noted the average therapy duration increased to 27 months and that approximately 45% of patients who stop therapy eventually restart. CEO Sanj K. Patel added that the sales force size is continuously evaluated using data-driven analytics and will be adjusted as needed to optimize market penetration.

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