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29 Sep 2025
Moonlake the red herring we thought it would be. Time to focus on galvo

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Moonlake the red herring we thought it would be. Time to focus on galvo
What happened?
The much-awaited Moonlake Ph III 16-week data for sonelokimab in HS (IL17A/F nanobody; hidradenitis suppurativa) has materially underwhelmed, consistent with our expectations (see Thesis galvo-nised; bull-bear EUR373-130). Moonlake was perceived by some to be a significant threat to UCB''s key growth driver Bimzelx (see IQVIA data in US/EU worth flagging). We anticipate a wave of investors to step into the stock, based on incoming over the past few weeks, and in light of the $10bn peak sales potential for galvokimig. Both UCB and Moonlake are holding analyst calls today to discuss Ph II galvokimig and Ph III sonelokimab data. Finally, we note Merck KGaA has a 4% equity stake in Moonlake but has passed on the potential 10-15% royalty stream, which is now set to be materially delayed, and de minimis in our view.
BNPP Exane View:
. Why did we think Moonlake data was a red herring? - We have consistently argued the perceived competitive threat from Moonlake''s solenokimab to Bimzelx as overdone, arguing there was little biologic rationale that a nanobody construct targeting IL-17 A/F would result in materially higher efficacy than Bimzelx, a bispecific antibody targeting IL-17 A/F. Furthermore, Bimzelx has just posted highly encouraging 3-year data in HS, is approved across five indications (Ps/HS/PsA/AS/nr-axSpA) and across every major region (US/EU/Japan/China). Lastly biologic penetration in HS remains modest with recent data suggesting the prevalence could be as high as 1% of the population.
. HS market sizing likely to increase - UCB recently estimated peak biologics penetration at least 50% by the end of the decade (equating to 200k patients in the US, EU5 and JP alone) as well as highlighting efforts to improve time to diagnosis which stands 7 years in the Europe and the US. There are an estimated 80k HS patients currently treated with Bimzelx with US dynamic patient share in April 2025 reaching 26% and Rx trends showing no signs...