Relfydess - If At First You Don't Succeed

研报英文原文证据摘录

Relfydess - If At First You Don't Succeed

d2030Other2031Sales 2032 2033

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Source: Jefferies research

We see Relfydess FDA decision as more minor to Group near-term numbers than

perhaps expected: Our forecasts, which currently assume FDA approval of Galderma's

new neuromodulator Relfydess around July, see 2% upside to cons 2027 Group Net Sales

estimates, driven by higher Neuromodulators, Nemluvio & Derma Skincare. The delay to

Relfydess will likely only lower our Group Net Sales forecasts for 2027 by c.1%, which still

suggests current cons expectations would be reasonable. Whilst this second delay will likely

weigh on sentiment and drive near-term stock weakness (JEFe mid-s.d. %) we would view any

pullback as a more attractive buying opportunity, given no impact on the LT growth potential.

CMC issues dominate FDA CRLs broadly - neurotoxins are highly CMC-sensitive: Across

recent FDA data c3/4 of CRLs involve manufacturing/CMC deficiencies. These include

process validation gaps, stability data deficiencies, analytical method validation and facility/

GMP issues. Neurotoxins are highly complex biologics, are produced via fermentation and

sensitive to subtle process variation. In addition, potency measurement is uniquely challenging

as potency is assay dependent and not standardised across products (FDA requires tight

control of assay reproducibility). Receipt of multiple CRLs is not uncommon (e.g. DAXXIFY)

and the Relfydess CRL does not reflect negatively on the likelihood of approvability in our view.

This also does not shift the competitive landscape as the same applies to other products in Benjamin Jackson * | Equity Analyst

development. +44 (0)20 7548 5146 | bjackson@jefferies.com

Michael Leuchten * | Equity Analyst