Galderma (AO) | Buy | Relfydess US CRL: delay, not a thesis change

研报英文原文证据摘录

Galderma (AO) | Buy | Relfydess US CRL: delay, not a thesis change

News comment

Release date: 01 July 2026

Justine Telliez

Equity Research Analyst

+33 1 53 65 35 94

jtelliez@keplercheuvreux.com

BuyGalderma

Switzerland | Pharma & biotech Beta Profile: MCap: CHF43.2bn

Target Price: CHF167.00 Bloomberg: GALD SW Reuters: GALD.S

Current Price: CHF183.90 Free float 65%

Up/downside: -9.2% Avg. daily volume (CHFm) 120.7

YTD abs performance 13.4% Market data: 30 June 2026

52-week high/low (CHF) 185.80/115.50

Relfydess US CRL: delay, not a thesis change

Key points:

Galderma has received a Complete Response Letter from the FDA for Relfydess in the US, with comments related to

manufacturing site inspection observations and analytical method optimisation. Importantly, the company states that all other

parts of the BLA, including safety and efficacy, did not solicit deficiencies to be addressed.

We expect headline pressure on the stock, as US approval was an anticipated catalyst. However, we would view any material

weakness as an attractive entry point, as this looks like a timing issue rather than a structural setback.

This does not change our investment case. US Relfydess approval was upside to Galderma’s current Neuromodulators trajectory,

not a prerequisite for the 2023-27E Injectables framework of +10-12% CAGR.

The key point is no longer whether Relfydess can become a relevant global neuromodulator, but when it reaches the US market.

The product is already approved in 33 markets and launched in more than 20, with encouraging early feedback from healthcare

professionals. The CRL does not affect approvals, launches or regulatory reviews outside the US, and the manufacturing site has

completed 10 inspections from key regulatory authorities since 2022.