Laura Sutcliffe

Laura Sutcliffe asked about the timeline for disclosing safety data for 591 (ProstACT Global part one) and the process for FDA submission, inquiring whether the company is awaiting FDA action or if the next steps are internal.

Answer

CEO Christian Behrenbruch explained that an independent data safety review board has already approved progression to randomization ex-U.S. for part two. The company is currently completing clinical case report forms and validating data internally. Public disclosure and FDA submission will occur simultaneously once this internal process is complete, with no delays expected from the FDA.

Laura Sutcliffe asked about the timeline for releasing safety data from the ProstACT Global study part one and the subsequent steps for FDA submission.

Answer

Christian Behrenbruch, CEO and Managing Director of Telix Pharmaceuticals, explained that the independent data safety review board has already reviewed the data, allowing ex-US randomization. He noted that the company is finalizing clinical case report forms and quality control for public disclosure and FDA submission, which is entirely on Telix's side and expected soon.

Laura Sutcliffe inquired about the stages of the patient funnel where ResMed has made the most impact in recent years and where further work is still needed.

Answer

CEO Mick Farrell identified the top of the funnel, driven by increased awareness from Big Pharma and Big Tech, as the area with the most progress. He highlighted ResMed's focus on expanding home sleep apnea testing (Virtuox, Ectosense) and improving clinic efficiency (Somnoware) as key areas for continued work.

Laura Sutcliffe inquired about which stages of the patient funnel, from initial PCP visit to first night with a ResMed device, have seen the most impact and where more work is needed.

Answer

CEO Mick Farrell stated that the most progress has been at the top of the funnel, driven by big pharma GLP-1s and big tech wearables increasing awareness. He identified challenges and ongoing work in scaling home sleep apnea testing through acquisitions like Ectosense (NightOwl), VirtuOx, and Somnoware, and partnering with HME customers via Brightree.

Laura Sutcliffe from UBS inquired about ResMed's ability to scale home sleep testing and remote setup to accommodate a potential influx of new patients, given that sleep physician capacity is constrained.

Answer

Executive Michael Farrell affirmed that scaling home sleep apnea testing (HSAT) is the key to flexing capacity for new patient demand. He explained that ResMed's strategy is to partner with sleep labs and HSAT companies to triage the majority of new patients to home testing, reserving in-lab capacity for more complex cases like central sleep apnea or overlap syndrome. He mentioned products like NightOwl and ApneaLink Air as part of the infrastructure to support this scaling.

Laura Sutcliffe inquired about any available data on preorders or initial demand for ResMed's new AirTouch N30i mask ahead of its launch.

Answer

CEO Michael Farrell explained that while it is too early for material financial data, there is "incredible excitement" from the commercial teams. He emphasized that the fabric-based technology is a potential "game changer" resulting from over a decade of development and represents a significant innovation in patient comfort.