Sadia Rahman

Sadia Rahman asked about the current penetration of the U.S. IgAN market for FILSPARI, its potential for further growth, and whether its expansion potential might be underappreciated given new competition.

Answer

Peter Heerma (Chief Commercial Officer) stated that FILSPARI's cumulative patient start forms don't even hit 10% of the addressable patient population, indicating substantial growth opportunity. He identified three categories for continued growth: replacing generic RAS inhibition, expanding the market by treating patients earlier, and increased combination therapies. Eric Dube (President and CEO) reiterated that IgA nephropathy alone for FILSPARI has a peak potential well above $1 billion.

Sadia Rahman asked about the current penetration of the U.S. IgA nephropathy market and FILSPARI's potential for further growth, considering street expectations imply a doubling of penetration from current levels.

Answer

Eric Dube, President and CEO, and Peter Heerma, Chief Commercial Officer, indicated that cumulative patient start forms for FILSPARI are less than 10% of the addressable IgAN population, suggesting significant growth opportunity. Peter outlined three growth categories: replacing generic RAS inhibition, expanding the market by treating earlier, and increased combination therapies. Eric reiterated FILSPARI's peak potential in IgAN alone is well above $1 billion.

Sadia Rahman from Wells Fargo inquired about the competitive landscape in FSGS, specifically regarding Dimerix's partnered asset, its potential benefits versus FILSPARI, and its development timeline.

Answer

Chief Medical Officer Dr. Jula Inrig responded that while it is positive to see FDA alignment on proteinuria as an endpoint, there is limited data on the competitor asset. She noted it will be 'many years' before its pivotal data is available as the trial is still enrolling. Dr. Inrig also suggested its mechanism could be complementary to FILSPARI in the future.

Sadia Rahman of Wells Fargo & Company questioned whether payers are reimbursing FILSPARI for IgAN patients with proteinuria below 1 gram/gram, given the pivotal trial's enrollment criteria, and if there has been any payer resistance.

Answer

Chief Commercial Officer Peter Heerma explained that the company educates payers on the progression risk even at lower proteinuria levels. He noted that while some payers are already updating their criteria, the majority of changes are expected in early 2025. He confirmed that they are beginning to see patients with lower proteinuria levels being treated with FILSPARI.

Sadia Rahman, on for Mohit Bansal at Wells Fargo, asked about trial design differences between LAUNCH-HTN and BAX HTN, whether pharmacokinetics or trial design would drive safety differences, and plans for releasing open-label extension data.

Answer

CEO Jon Congleton noted that while LAUNCH-HTN is the most comparable study, key design elements of BAX HTN are unknown. He emphasized that lorunderstat's distinct pharmacokinetics, including higher selectivity and a shorter half-life, are key differentiators. He confirmed plans to publish long-term efficacy and safety data from the TRANSFORM-HDN open-label study in due course, without giving a specific timeline.

Sadia Rahman, on for Mohit Bansal, asked about Amgen's confidence in the TEZSPIRE COPD program following a competitor's Phase 3 failure and questioned which patient profile, based on eosinophil levels, is most likely to benefit.

Answer

James Bradner, EVP of R&D, expressed high confidence, differentiating TEZSPIRE's TSLP pathway from the competitor's ST2 pathway. He stated the mechanism is strong, and response is likely linked to TH2 immunity, with blood eosinophil count as a potential biomarker.

Sadia Rahman of Wells Fargo Securities asked for an update on the expected timeline for the Post-Grant Review (PGR) decisions in the Merck IP case and what actions Halozyme might take if the outcome is unfavorable. She also questioned if the PGR case and the patent infringement lawsuit could be linked.

Answer

Dr. Helen Torley, President and CEO, stated that the initial PGR institution decision is expected in early June. She characterized the PGR as a "side show," expressing confidence in Halozyme's position and noting that even an unfavorable PGR outcome would not impact the separate, more critical infringement lawsuit, which is based on additional claims not subject to the PGR.