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Analyst Comment

Gubra: Q1 2026 trading statement, pipeline momentum offsets softer CRO outlook

By Michael FriisHead of Equities
Gubra

Summary

  • Gubra's Q1 2026 rapport viser betydelig fremgang i bioteknologi, med to Gubra-opdagede lægemidler, der går ind i fase 2 forsøg i år, hvilket kan øge sandsynligheden for markedsintroduktion.
  • Biotek-indtægterne steg til DKK 28 mio. i Q1 2026, drevet af en Amylyx-milestone, mens CRO-indtægterne faldt 6% år-til-år, hvilket førte til en nedjustering af 2026 guidance.
  • Ledelsen bekræftede en milepælspotentiale på USD 1,9 mia. for ABBV-295 og ~EUR 240 mio. for BI triple agonist, med fase 2 start som potentielle milepælsudløsende begivenheder.
  • UCN2-programmet oplever forsinkelser på grund af kompleksitet i forsøgsdesign, men der er ingen sikkerhedsproblemer, og det positioneres som et supplement til eksisterende GLP-1 behandlinger.

Dette indhold er genereret af AI. Du kan give feedback om det på Inderes forum.

Gubra delivered its Q1 2026 trading statement yesterday, and the headlines are dominated by Biotech progress: AbbVie's ABBV-295 MAD data (~10% weight loss in 12-13 weeks, with comparable efficacy on every-other-week and monthly dosing) and the BI 3034701 triple agonist are both confirmed for Phase 2 entry in 2026, Q3 and mid-year, respectively. 

Beyond obesity, partner Amylyx selected AMX0318 (a long-acting GLP-1 receptor antagonist) as development candidate for post-bariatric hypoglycemia and other rare diseases, with IND targeted for 2027. The internal UCN2 program had its CTA submitted in Germany in February for a comprehensive Phase 1/2a trial of ~188 participants, though first patient first visit (FPFV) has been pushed from H1 to H2 2026, and the previously planned 30 June Capital Markets Day has been rescheduled to follow FPFV. Gubra also formally launched its Ventures unit during the quarter.

Financially, Q1 2026 Biotech revenue came in at DKK 28m (vs. DKK 7m in Q1 2025), driven by an Amylyx milestone, with EBIT improving to DKK -39m (vs. DKK -54m). CRO external revenue was DKK 47.7m, up 26% sequentially from a soft Q4 2025 but down 6% year-on-year, with EBIT essentially at break-even (DKK 0.2m vs. DKK 10.8m in Q1 2025).

The weaker-than-expected development in CRO meant that 2026 guidance was cut. Revenue growth is lowered to 0-10% (from 5-15%) and EBIT margin to 10-15% (from 20-25%).

Biotech cost guidance is unchanged at DKK 330-360m.

On the following conference call there were several read-across important to our investment case.

The most material confirmation is that two Gubra-discovered assets are now headed into Phase 2 this year. The most important takeaway is that two Gubra-discovered drugs are now moving into Phase 2 trials this year. This is in line with what we already assumed in our valuation model, but it confirms the timeline. For ABBV-295 specifically, reaching Phase 2 matters because obesity peptide drugs at that stage have a much higher historical chance of eventually reaching the market, around 46%, compared to roughly 26% for obesity drugs at Phase 1. Transition into Phase II may therefore see the market price in a greater Probability of Success via valuation appreciation to reflect this higher historical benchmark.

Management reiterated the USD 1.9bn remaining milestone potential on ABBV-295 and ~EUR 240m on the BI triple agonist, both with development and sales components plus royalties - meaning the Phase 2 starts are themselves likely milestone-triggering events, though individual values are not disclosed.

A useful point from the Q&A: the ongoing AbbVie Phase 1b study is designed to test ABBV-295 in the patient group that matters most for the obesity market. The just-reported MAD trial was run in a mostly male, non-obese group, which has made it harder to compare ABBV-295 directly to Lilly's eloralintide. The new Phase 1b enrolls patients with a BMI of 30-45 and more women i.e., a population that better reflects real-world obesity patients. This helps answer one of the key open questions in our investment case: whether ABBV-295's strong ~10% weight loss over 12-13 weeks holds up in heavier patients.

On UCN2, management was clear that the delay to first patient dosing is driven by the complexity of the trial design, which measures both muscle volume and muscle function, and ongoing dialogue with the German regulator and ethics committee on the protocol and patient consent forms. Importantly, there are no safety or preclinical concerns behind the delay. Management also gave a sharper description of where UCN2 fits commercially: it is not positioned as a standalone obesity drug, but as an add-on to existing GLP-1 treatments to help preserve muscle and physical function during weight loss, with potential to expand into metabolic and heart/kidney indications longer term. This positioning aligns well with the post-CagriSema market view that future obesity assets need to offer something genuinely differentiated, not just more weight loss.

On the CRO cut, management pointed to soft demand among smaller biotechs in the US and longer decision cycles, while flagging early signs of pickup among large pharma in obesity and MASH.

Net-net, Q1 2026 reinforces our view that the equity story remains pipeline-driven, with two Phase 2 transitions in 2026 as the primary value-inflection events, UCN2 FPFV slipping into H2 as a watch-item, and the CRO segment now delivering a smaller cushion than previously assumed. The investment thesis is intact; the catalyst calendar has tightened toward H2 2026.

On Tuesday 12 May at 13:00 CEST the management will present the results followed by a Q&A session. Sign up and submit your questions. 

https://www.inderes.dk/videos/gubra-praesentation-af-q1-2026-handelsopdatering

Disclaimer: HC Andersen Capital receives payment from Gubra for a Digital IR/Corporate Visibility subscription agreement. /Michael Friis 11:03 07/05-2026

 

Gubra is a pharmaceutical company. The company's operations are focused on the early stages of drug development. They primarily conduct research and development in the area of metabolic and fibrotic diseases. The company's product portfolio includes several brands and drugs, and the operations are conducted on a global level, with the largest presence in North America and the Nordic region. The headquarters are located in Hørsholm, Denmark.

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