Zealand Pharma
Gubra amylin data impresses, but we remain bullish Petre [rsch.baml.com]
Maintain Rating: BUY
PO:1,000 DKK | Price:491.00 DKK
Equity | 01 April 2025
Key takeaways
· Gubra first multi dose data for its amylin demonstrates impressive 8% weightloss at 6 weeks (directionally stronger vs Petre)
· But key potential differentiator for amylins in obesity is a very clean tolerability profile, with Petre PIb data a high bar
· We continue to see Petre as a potentially best in class amylin with most complete/consistent data and 1.5-2y ahead of Gubra
First Gubra MAD data impressive, but we still like Petre
Today Gubra press released first interim MAD data for its amylin GUBamy (recently licensed to AbbVie, covered by Tim Anderson), demonstrating c8% weightloss on day 43 (c10% placebo adjusted), which looks impressive for the amylin class, and directionally stronger than Zealand's Petre (c5% in a similar trial). However we think the key potential differentiator for amylins in obesity is the improved tolerability profile, with limited colour from the GUBamy data today, and we think Petre's impressive PIb data (see details [rsch.baml.com]) sets a high hurdle for competition. At this stage, we continue to see Zealand's Petre as a potentially best-in-class amylin, with the most complete and consistent dataset across trials and c1.5-2y ahead of Gubra/ABBV. The Cagri data (very similar molecule structure to Petre) also supports our Petre confidence, vs Gubra's less-validated adrenomedullin backbone. As a reminder, Zealand signed a partnering agreement with Roche in March, which we saw as a best-case scenario for Zealand (see our feedback [rsch.baml.com]). Reiterate Buy (see our deep dive [rsch.baml.com]) for a best-in-class amylin now with a clear path to market and a very strong commercialisation partner. Zealand is on our "What's big in SMID" list of top ideas. See overleaf for debates on recent stock weakness
Gubra's first MAD data looks impressive (8% weightloss)
Gubra presented its first interim MAD data for its amylin (dual amylin/calcitonin agonist), demonstrating an impressive 7.77% weightloss on day 43 (vs placebo 1.99% weight gain) - almost 10% placebo adjusted. Release suggested AE's predominantly GI, mild and consistent with the SAD study. In its SAD trial, GUBamy 2.0mg looked fairly tolerable, with 17% GI AEs, and directionally better than the 3.5-6.0mg doses. Beyond data today, Gubra is assessing 3 further doses (we assume the 3.5, 4.75 and 6.0mg doses assessed in its SAD trial) in part B of its MAD over 12 weeks of treatment, with expected completed dosing 4Q25E. Although headline data looks impressive, we caveat: 1) this is headline weightloss data for one dose across 6 patients (and 2 patients in the placebo arm); 2) limited details on tolerability profile, which is our focus as detailed below; 3) surprising GUBamy SAD weightloss curves (maintained weightloss to 43 days, despite an 11 day half-life) are still debated (and 2.0mg saw limited 1 dose efficacy).
Key differentiator for Petre is its tolerability profile
The Petre weight loss (c8-9% at 16-weeks) is sufficient to support its PIII target 15-20% weightloss (and the majority of obese patients who need 10-20% weightloss), in our view, but the key differentiator for us for Petre is its very clean tolerability and safety profile. As a reminder, in its 16-week PIb trial, across the highest two doses, PIb data demonstrated very low tolerability (17% nausea, c4% vomiting) for a PI trial with rapid dose escalations. Additionally it saw: 1) a low portion of moderate events, with c10% of GI events moderate (vs approved GLP1's c20-30%), and often higher for pipeline GLP1's; 2) very clean safety profile, with 2.4/4.8mg doses almost in line placebo, and 9.0mg only slightly worse; 3) ease of titration/ compliance, with only 1 patient discontinuing due to AE's, and only 1 patient delaying dose escalation by 1 week.