We began 2025 with enhanced profitability and significant progress in our core business and R&D programs. Buvidal® sales and patient numbers continued to increase in Europe and Australia. Royalties from Braeburn’s net sales of Brixadi® in the US grew significantly versus the prior year, however, were flat versus the prior quarter. The EU regulatory review of CAM2029 advanced and led, after the quarter, to a positive CHMP opinion for marketing authorization of Oczyesa® for the treatment of acromegaly in the EU, alongside the progress of clinical programs for CAM2029 in polycystic liver disease and neuroendocrine tumors. In the early pipeline, treatment was initiated in the Phase 1 study of a monthly semaglutide (CAM2056) depot in participants with overweight or obesity.

Strong financial performance and record-high profitability

Camurus had a positive first quarter with solid growth and strong profitability. Total revenues increased by 43 percent to SEK 558 million, while operating expenses remained steady at SEK 289 million compared to the previous year. The operating result in the quarter increased by 204 percent to SEK 239 million. The profit before tax amounted to SEK 254 million, Camurus’ best result to date from ongoing operations. The cash position at the end of the quarter was SEK 2.9 billion.

Robust Buvidal sales growth in Europe and Australia

During the quarter, we continued to strengthen our market-leading position within the long-acting injectable (LAI) buprenorphine segment across our markets in Europe, Australia, and the MENA region. Buvidal achieved product sales of SEK 485 million, 33 percent year-on-year and 3 percent (6 percent at constant exchange rates) versus a strong Q4 2024. The estimated total number of patients in treatment with Buvidal increased net 3,000 to 63,000. The growth was led by the UK, Australia, Germany, and the Nordics.

In addition to growth in established markets, we continued our efforts to expand the market and increase access to treatment with Buvidal. Launch processes and treatment of patients began during the quarter in Switzerland and Luxembourg, alongside preparations for a planned sales start in Portugal in May. Additionally, a new marketing authorization approval for Buvidal was obtained in Serbia.

First quarter challenges in the US opioid use disorder market

First quarter royalties on Braeburn’s net sales of Brixadi* for opioid use disorder (OUD) in the US grew 185 percent year-on-year to SEK 74 million. Compared to the previous quarter, reported royalties decreased by 11 percent due to currency effects, but were flat at constant exchange rate (+1 percent). At the same time, the overall US buprenorphine market decreased by 13 percent compared to the previous quarter.¹ Both new patient initiations and the number of patients in treatment were affected.

In the first quarter, headwinds in the US OUD market includes seasonal renewals of prescription authorizations, unwinding of the Medicaid continuous enrollment condition, and federal bud get cuts that have reduced access to treatment in parts of the correctional system. Growth in other segments has not yet offset these impacts.^2-5 These circumstances are viewed as transient and resumed growth is expected later in the year, driven by a high unmet medical need for effective OUD treatments alongside positive market dynamics in the commercial segment. Our licensee, Braeburn, expects renewed growth of Brixadi in the coming quarters.

This should be seen in the light of a recently announced potential pricing reform communicated in the form of an executive order by the President of the United States. Possible timelines and consequences of this reform remain unclear.

CAM2029 progress with CHMP recommendation for market approval for Oczyesa® in the EU

In the late-stage development portfolio, the regulatory review and clinical studies of our octreotide subcutaneous depot (CAM2029) progressed across indications: acromegaly, gastroenteropan creatic neuroendocrine tumors (GEP-NET), and polycystic liver disease (PLD).

The review process of our regulatory application for CAM2029 for the treatment of acromegaly progressed, and a positive opinion from the European Medicines Agency’s Scientific Committee for Medicinal Products for Human Use (CHMP) was adopted after the period, recommending marketing authorization for Oczyesa® (CAM2029) for maintenance treatment of adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues. We are very pleased with the outcome of the CHMP’s review and look forward to a final decision from the European Commission in the coming months. The launch of Oczyesa® in the first markets in the EU is planned for the second half of this year. An updated filing with the US Food and Drug Administration (FDA) is planned after the completion of an inde pendent audit of a third-party manufacturer scheduled at the end of the second quarter.

In parallel with these processes, our large randomized, active controlled Phase 3 study of CAM2029 for the treatment of GEP-NET, SORENTO, advanced, in line with previously updated timelines.
The randomized part of the study is expected to be completed in the early part of 2026. The study has progressed well with continued positive feedback from our clinical investigators and participants in the study. Aside from the clinical study, preparations are also under way for the commercialization of CAM2029 in GEP-NET.

In the PLD program, the treatment of the last patients in the ran domized, placebo-controlled, double-blind phase of the POSITANO study was completed. The study compares efficacy and safety of treatment with CAM2029 versus placebo in patients with symptomatic PLD and primary results are expected in the current quarter.

Following the completion of the randomized part of the POSITANO study, patients have entered an open-label extension phase for monitoring long-term safety and efficacy. PLD is a rare and serious chronic medical condition without approved medical treatments.

Clinical study assessing once-monthly semaglutide depot

During the quarter, significant progress was made in the randomized, active-controlled Phase 1 study of semaglutide monthly depot (CAM2056) in participants with overweight or obesity who are otherwise healthy. The study characterizes pharmacokinetics and pharmacodynamics, including weight loss and safety, of repeated dosing of CAM2056 compared to semaglutide weekly injection (Wegovy). Most of the study participants have now been included in the study, and results are anticipated in the latter half of the year.

Other long-acting incretins progressed alongside CAM2056 during the quarter.

Organization and improved ESG rankings

In the quarter, we announced that Jon Garay Alonso will leave the position as our CFO in August. After a successful recruitment process, I was pleased to announce Anders Vadsholt as Camurus’ next CFO and member of the executive management team, effective 1 July 2025. With his extensive financial and M&A expertise from executive roles in the biotech and pharmaceutical sector, Anders is an excellent successor as CFO, and Jon will ensure a smooth transition of responsibilities before departing.I want to take the opportunity to thank Jon for his significant contributions to Camurus and wish him the best in the future. During the period, we continued our efforts to further develop and strengthen Camurus’ sustainability profile and performance across the organization. It was gratifying to receive information that Camurus was awarded the EthiFinance ESG Platinum Medal this quarter. This highlights our commitment to creating value for patients, caregivers, and society, while minimizing sustainability-related risks and reducing our environmental footprint across the entire value chain. Camurus consistently ranks highly among pharmaceutical companies in well-known sustainability rankings. To learn more, please refer to our Sustainability Report included in our Annual Report 2024, published after the period.⁶

Camurus had a productive and highly profitable start of 2025

The first quarter has been productive with good growth, high profitability, and progress in the development portfolio. Our strong balance sheet gives us the flexibility to invest in the expansion and diversification of our development portfolio, expected CAM2029 launches in acromegaly, GEP-NET and PLD, as well as in ongoing business development and additional manufacturing capacity in line with our long-term strategy.

Upcoming catalysts include results from the POSITANO study of CAM2029 in PLD, EU marketing approval for Oczyesa® for the treatment of patients with acromegaly, and resubmission of a New Drug Application for CAM2029 to the FDA. Our commercial preparations for CAM2029 are progressing in the EU and the US to be ready for launch shortly after market approval. Additionally, our important work continues to improve access to treatment for patients with opioid dependence and to ensure continued positive sales development in our own markets and the US.

Fredrik Tiberg

President and CEO

* Brixadi® is the US brand name for Camurus’ product Buvidal®