GALD: Manufacturing-related CRL adds further delay to Relfydess US approval

Research evidence excerpt

GALD: Manufacturing-related CRL adds further delay to Relfydess US approval

EQUITY RESEARCH QUICK TAKE

RBC Europe Limited

Natalia Webster, CFA (Analyst)

Charles Weston, CFA (Analyst)

July 1, 2026

Galderma Group AG

Manufacturing-related CRL adds further delay to Relfydess US approval

SWX: GALD | CHF 183.90 | Sector Perform | Price Target CHF 155.00

Sentiment: Negative

Our view: We view this as a further delay to US Relfydess approval rather than a fundamental issue. Galderma states that it is

implementing corrective and preventive actions and plans to respond "rapidly" to the CRL, with advancing Relfydess in the US

remaining a "top priority". However, the timeline to resolution remains uncertain and will depend on the nature of corrective

actions required (the FDA's comments in the CRL relate to observations made during manufacturing site inspection and analytical

method optimisation) and any subsequent re-inspection. While we expect limited impact to 2026, and that Dysport will continue

to drive neuromodulator growth in the interim, the mid-term margin impact is more relevant. We have previously highlighted

Relfydess as a key driver to mid-term margin expansion due to its superior economics to Dysport (with lower royalty burden and

internal manufacturing), and a further approval delay pushes back the point at which these benefits begin to accrue in the US.

What has happened? Galderma has received a Complete Response Letter (CRL) from the FDA regarding its Biologics License

Application for RelabotulinumtoxinA (Relfydess). This cites observations from a Pre-License Inspection of the manufacturing site

and requests related to analytical method optimisation. The company confirmed that all other aspects of the BLA, including safety