How will the CE marking of Contivue with Susvimo affect Roche's upcoming quarterly earnings and revenue forecasts?

The EU‑wide CE mark for Contivue + Susvimo is a clear “regulatory win” for Roche and removes a major hurdle for a next‑generation, long‑acting ranibizumab platform in Europe. Because the drug component (ranibizumab) is still pending EMA approval, the first‑quarter impact on revenues will be modest – essentially the incremental contribution of the implantation kit and any early‑access sales, which analysts estimate to be in the low‑single‑digit‑million‑euro range. However, the approval unlocks a $2‑3 bn market for neovascular AMD in the EU and positions Roche to capture a sizable share of the anticipated shift from monthly injections to quarterly or longer‑duration delivery. When the EMA decision arrives (likely in Q4‑2025), Roche can begin to book the full device‑plus‑drug revenue stream, which management has hinted could lift the 2025‑2026 outlook by 3‑5 % (≈ €1.2‑€1.5 bn of incremental sales).

From a technical standpoint, RO shares have been trading in a tight range between €280‑€295 since the earnings beat in Q2, with the 50‑day SMA around €285 acting as support. The CE‑mark news sparked a brief rally to €298 before profit‑taking, suggesting the market has already priced in a “regulatory tailwind” but remains cautious about near‑term earnings materiality. For traders, the pattern points to a potential breakout above the €300 resistance on any EMA approval or early commercial data, which could trigger a short‑term upside run. Conversely, a delayed EMA decision or weaker‑than‑expected uptake would likely see the stock revert to its 200‑day SMA (~€275). Actionable take‑away: maintain a neutral stance now, with a small long position targeting a break above €300 on EMA approval, while protecting downside with a stop at €275. This positioning captures upside from the upcoming revenue lift without over‑leveraging on a catalyst that may not affect Q3 earnings.