Mike Ulz

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 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 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.