ZEALAND PHARMA (=) : Survodutide falls flat at ADA, safety still an issue

Research evidence excerpt

ZEALAND PHARMA (=) : Survodutide falls flat at ADA, safety still an issue

in sema/tirzepatide trials), this was overshadowed by the poor

safety profile. There was also a large placebo effect, reflecting 16% of placebo patients using other prohibited weight

loss medications during the study. Discussants at pains to highlight the “rigidity” of the trial design with forced dose

titration schedules regardless of side effects and highlighted the late introduction of protocol amendments which meant

only 75% patients only had 3 months left in the trial when flexible dosing brought in. However, with plenty of alternatives

on the market and more in the near-term pipeline, we struggle to see how survo will be competitive in obesity with data

presented to-date. Continued execution of the buyback may mask some impact but ultimately we expect a negative

market reaction today.

We have long believed that MASH will be the primary opportunity for survodutide which justifies the majority of our

DKK2.0bn risk-adjusted peak sales (DKK3.0bn non-risk-adjusted). Registrational data from the LIVERAGE program is

not anticipated until 2027e, though data from a n=218 imaging study (SYNCHRONIZE-MASLD) was presented at ADA

showing ≥30% reductions in liver fat content in more than 80% of participants and 60% of participants in the trial

achieving normalised liver fat (≤5% fat content) at Week 48. While data promising, our ADA weekend takeaways also

highlights (i) GIP/Glucagon agonists being flagged as “the next big thing”, (ii) much anticipation for NOVO’s FGF21

MASH data and (iii) strong retatrutide liver data presented at the conference indicating an increasingly competitive

environment in MASH and a tall order for survo to deliver competitive data from the LIVERAGE program next year.