Camurus’ first quarter 2026 results were in line with our expectations and full-year guidance. Following changes to the distribution model in the UK in Q4 2025, sales revenues recovered, while our R&D pipeline continued to advance. We are expecting the approval decision for Oclaiz™ in the US on 10 June and thereafter look forward to completing the randomized part of the SORENTO study in GEP-NET and sharing the primary Phase 3 results.

The company’s total revenues for the quarter amounted to SEK 533 million, up 15 percent sequentially from Q4 2025. The year-on-year decline of 5 percent (increase of 3 percent at CER) versus Q1 2025 primarily reflects currency effects alongside modest sales in January. The operating result amouted to SEK 168 million, corresponding to a margin of 32 percent. We ended the quarter with a strengthened net cash of SEK 3.9 billion, an increase of 35 percent, and our full-year financial outlook is reiterated.

Buvidal® growing with improving market access

Reported Buvidal sales in Q1 were down 13 percent year-on-year, but increased 24 percent compared to the previous quarter. Sales were impacted by the UK distributor model transition in 2025, which included a one-time inventory repurchase of SEK 93 million in Q4 2025 and elevated channel sales in Q1 2025, creating a high comparison base.

In-market Buvidal sales grew 17 percent year-on-year, with solid performances in the Nordics, Germany, France, and Spain. In Portugal, early commercial momentum is encouraging following a new funding decision for Buvidal late last year. In Australia, a seasonal softness from summer vacations was noted, and funding constraints from 2025 continued to affect patient access in the UK. On the positive side, a new budget and three-year funding alloca-tions were announced for the new NHS financial year, beginning 1 April, 2026. This is expected to support improved patient access to treatment in the UK throughout the remainder of the year and beyond. At the end of Q1, approximately 73,000 patients were estimated to be in treatment with Buvidal. With the new multi-year framework for funding in the UK and positive signals on access developments in other markets, we continue to work towards our vision, communicated autumn 2022, of 100,000 patients in treatment at the end of 2027.

Brixadi® building market share in the US

Royalty income from Braeburn’s net sales of Brixadi* grew 44 percent year-on-year (59 percent at CER) to SEK 106 million in the quarter. Brixadi continued to gain share in the US LAI buprenorphine segment, reaching approximately 32 percent of equivalized units in Q1 2026 compared with 26 percent a year earlier.1 The performance reflected the occurrence of seasonal prior authorization renewals and payor mix pressure in Q1. These effects will normalize as the year progresses. Braeburn continues to invest significantly in growing the Brixadi franchise, including expanded patient-facing commercial activities. To date, sales in the US are on track and expected to accelerate as Brixadi gains share in the large and still underpenetrated US market for opioid use disorder.

Oczyesa® momentum in Europe and US approval decision for Oclaiz in sight

Oczyesa delivered its first full quarter with sales of SEK 4 million, underpinned by early positive momentum in Germany and ongoing launch preparations in the UK and the Nordics. In the US, the FDA accepted the NDA for Oclaiz** for review with a PDUFA action date of 10 June, 2026. Based on previously available information, no outstanding issues remain with respect to CAM2029 or its clinical efficacy and safety. We understand the review to be primarily focused on the status of corrective and preventive actions implemented by the contract manufacturer as per the complete response letter received by Camurus in October 2024. Meanwhile, our commercial and medical teams are gearing up for the US launch. Camurus will have a significant presence at the ENDO 2026 conference in Chicago 13-16 June, an important platform for evidence dissemination shortly after the FDA decision. In addition to the US, two regulatory reviews are currently ongoing.

Pipeline progress and key R&D milestones

During the quarter, the pivotal Phase 3 SORENTO study of CAM2029 continued to progress in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NET). We are looking forward to completing the randomized part of the trial in the second half of the year and thereafter read out primary results regarding superiority of CAM2029 compared to first-line standard of care. A successful outcome would represent a major milestone for Camurus and for patients with GEP-NET. In addition to GEP-NET, during the quarter we completed an End-of-Phase 2 meeting with the FDA regarding the further development of CAM2029 for the treatment of patients with polycystic liver disease (PLD). Next steps will be informed by the Agency’s Phase 3 guidance alongside new expected data from the ongoing POSITANO extension study.

For CAM2056, our monthly semaglutide depot, regulatory feedback was received by the FDA and study preparations are advancing towards study initiation of a planned Phase 2 study in the second half of 2026. In parallel, our R&D teams are proceeding with the development of the final product format, including a new autoinjector pen intended for Phase 3.

Alongside these developments, our collaborations with Eli Lilly on other long-acting incretins, and with Gubra for long-acting PTH-agonists progressed.

Strengthening corporate development

We were pleased to welcome Jane Buus Laursen as Chief Corporate Development Officer during the quarter, strengthening our leader-ship team as Camurus enters a pivotal phase of growth.

First quarter on track; 2026 guidance reaffirmed

All in all, Camurus’ first quarter performance in 2026 was in line with our expectations, delivering robust cash flow and further strengthening our financial position. We are projecting accele-rated commercial performance during the remainder of the year as new market access initiatives to improve patients’ access to effective treatment options are coming into effect. With two marketed products gaining share, a potentially transformative Phase 3 readout in GEP-NET, a differentiated GLP-1 asset, and strategic partnerships with leading pharma companies, Camurus offers profitable growth and pipeline catalysts, and is well positioned to deliver on its 2026 objectives – ultimately improving the lives of patients with severe and chronic conditions. 

Fredrik Tiberg

President and CEO

* Brixadi® is the US brand name for Camurus’ product Buvidal®
** Oclaiz™ is the proposed US brand name for CAM2029 for the treatment of acromegaly.