Mike Ulz

Mike Ulz asked for clarification on IMCIVREE sales trends, specifically how to interpret the potential dampening of sales in Q1 due to a pull-forward effect from Q4, inquiring if it would result in slower growth or a flattish performance.

Answer

Hunter Smith, Chief Financial Officer, declined to comment on external estimates but noted that the company experienced negative growth from Q4 2024 to Q1 2025. He explained that the Q4 inventory buildup represents a pull-forward of sales from Q1 and highlighted typical Q1 challenges such as plan renewals and patient transitions to bridge programs.

Mike Ulz asked for clarification on IMCIVREE sales trends, specifically regarding the potential dampening effect on Q1 sales due to a pull-forward in Q4, inquiring whether to expect slowing growth or a flattish trajectory.

Answer

Hunter Smith, Chief Financial Officer, explained that while he wouldn't comment on external estimates, the company experienced negative growth from Q4 2024 to Q1 2025 due to inventory dynamics. He noted that the current inventory buildup is less in absolute terms but still represents a pull-forward of sales. Smith also highlighted typical Q1 challenges like plan renewals and patient rotations onto and off bridge programs.

Mike Ulz asked about market share trends for AMVUTTRA in cardiomyopathy, particularly regarding the continuation of share gains in the second-line setting and positive trends in the front line, and if these front-line share trends are expected to increase throughout the year.

Answer

Chief Commercial Officer Tolga Tanguler noted that AMVUTTRA is approaching parity with tafamidis in new-to-brand dynamics. He stated that the confidence in the 2026 guidance is driven by continuous progress in first-line access, increasing physician and patient preference, and healthy category growth, all of which have strengthened. CEO Yvonne Greenstreet also mentioned an upcoming TTR webinar in March to discuss future franchise building.

Mike Ulz asked about cardiomyopathy market share trends, particularly the strong gains in the second-line setting and positive trends in the front line, and whether these front-line share trends are expected to continue increasing throughout 2026.

Answer

Tolga Tanguler, Chief Commercial Officer, expressed satisfaction with the broad and balanced access, noting AMVUTTRA is approaching parity with tafamidis in new-to-brand dynamics. He affirmed confidence in the 2026 guidance, driven by continuous progress in first-line access, rising physician and patient preference, and healthy category growth. Yvonne Greenstreet, CEO, mentioned an upcoming TTR webinar in March to discuss building the franchise.

Mike Ulz asked for a breakdown of Redemplo patient categories (expanded access, naive, and switch) and the key reasons for patient switching, including any impact from coverage and pricing.

Answer

Andy Davis, SVP and Head of Global Cardiometabolic Franchise, stated that the vast majority of patient originations were from the APOC3 naive segment, with the remainder split evenly between switch patients and those transitioning from the expanded access program. He noted that efficacy and safety were the principal drivers for physicians considering Redemplo as an alternative for switch patients.

Mike Ulz asked about the patient breakdown for REDEMPLO prescriptions, specifically inquiring about the proportion of patients transitioning from expanded access, those naive to the APOC3 class, and switch patients. He also sought reasons for patient switching, including potential impacts of coverage and pricing.

Answer

Andy Davis, SVP and Head of Global Cardiometabolic Franchise, explained that the majority of REDEMPLO prescriptions are from APOC3 naive patients, with the remainder split evenly between expanded access and switch patients. He noted that efficacy and safety are the primary drivers for patients switching to REDEMPLO.

Mike Ulz with Morgan Stanley followed up on the SHASTA III and IV studies, asking if Arrowhead is considering any adjustments or fine-tuning to the study designs, beyond adopting the modified Atlanta criteria, after reviewing more detailed core study data.

Answer

James Hamilton, Chief Medical Officer and Head of R&D for Arrowhead Pharmaceuticals, confirmed that other than adopting the modified Atlanta criteria, the company feels confident in the current study design, which was negotiated with the FDA. He stated that nothing observed in the core studies indicated a need for further changes to the SHASTA III and IV protocols.

Mike Ulz asked if Arrowhead is considering any adjustments or fine-tuning to the SHASTA III and IV studies, beyond adopting the modified Atlanta criteria, after reviewing more details from the core studies.

Answer

James Hamilton, Chief Medical Officer and Head of R&D, confirmed that no other changes are being considered beyond adopting the modified Atlanta criteria. He stated that the study design was negotiated with the FDA, and nothing from the core studies indicated a need for further modifications.

Mike Ulz asked for updated thoughts on olzarsen pricing for sHTG, acknowledging ongoing work and seeking clarity on when more information might be available.

Answer

Kyle Jenne, Chief Global Product Strategy Officer, Ionis, explained that pricing work is ongoing, incorporating CORE and CORE2 data, including hospitalization rates and number needed to treat (NNT) data to be released at AHA. He noted that payers would consider the market of over 3 million patients and their total exposure. Final pricing will be announced upon sHTG indication approval, similar to previous launches.

Mike Ulz asked for updated thoughts on the pricing strategy for Olzarsen in SHTG, and when more clarity on pricing might be expected.

Answer

Kyle Jenne, Chief Global Product Strategy Officer, indicated that pricing work is ongoing, incorporating CORE and CORE 2 data, hospitalization rates, and Number Needed to Treat (NNT). He expects more information next year and noted that payers would consider the total exposure in a market of over 3 million patients. The final price will be announced upon SHTG approval.

Representing Mike Ulz, Rohit asked for a breakdown of the Q3 DANYELZA sales decline, attributing it to seasonality, competition, and clinical trials, and requested more detail on the change in estimate for Medicaid claims.

Answer

Chief Financial Officer Pete Pfreundschuh clarified that the number of sites with higher Medicaid populations is increasing, leading to a $1.5 million downward adjustment in Q3. He also noted a $700,000 shipment timing issue that pushed sales into Q4. Chief Commercial Officer Sue Smith added that despite headwinds, key performance indicators like physician and patient starts are growing, particularly in high-volume centers, driven by a new competitive campaign focused on DANYELZA's value proposition.