Question · Q4 2025
Mike Nedelcovych inquired about the status and impact of the FDA's draft guidance limiting comparative efficacy studies for biosimilars on Organon's business, and sought more detail on Nexplanon's contribution to 2026 sales guidance, particularly if the five-year implant launch would be accretive.
Answer
Joe Morrissey, Organon's Interim Chief Executive Officer, indicated that the biosimilar guidance would likely have an incremental impact. Matt Walsh, Organon's Chief Financial Officer, explained that Nexplanon sales are expected to be roughly flat year-on-year in 2026 due to offsetting factors, with a temporary dip from reinsertions due to the five-year label, but long-term optimism remains.
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