Camurus demonstrated solid performance in the fourth quarter, marked by increased patient uptake of Buvidal® and Brixadi® and the launch of Oczyesa® in Germany. Total revenues and profit were at the low end of forecasts, mainly due to a change to the UK distribution model and FX headwinds. In the R&D pipeline, the New Drug Application for Oclaiz™ for the treatment of acromegaly was resubmitted to the US FDA. The SORENTO study advanced in neuroendocrine tumors, and our Phase 1b study showed that monthly semaglutide (CAM2056) resulted in faster and greater body weight and blood glucose reductions compared to currently marketed weekly product, Wegovy®, with a similar safety and tolerability profile. Additionally, a new partnership was entered with Gubra for the development of long-acting parathyroid hormone analogues.

Fourth quarter results impacted by FX rates and change to the UK distributor model

Total revenues in the quarter amounted to SEK 464 million, a decrease of 16 percent (3 percent at CER) versus the same quarter previous year. The decrease was due to impact of exchange rates and a one-time repurchase of inventory of SEK 93 milion following a change in the UK distribution model at the end of the period.

Excluding these effects, total revenues were SEK 580 million, an increase of 14 percent at CER. Operating expenses were reduced by 12 percent to SEK 316 million, resulting in a fourth quarter oper-ating result of SEK 113 million.

For the full year 2025, Camurus’ total revenues increased by 21 percent (30 percent at CER) to SEK 2,265 million, while operating expenses remained steady at SEK 1,237 million. The operating result increased by 86 percent to SEK 874 million. The company’s profit before tax increased by 69 percent (98 percent at CER) to SEK 933 million, which is at the lower end of our full year 2025 guidance. An anticipated sales milestone payment from Braeburn for Brixadi has been deferred to 2026. The profit margin before tax reached 41 percent.

Camurus continued delivering sustainable profitability, concluding the year with a net cash of SEK 3.7 billion. With this solid financial foundation, we are well positioned to advance strategic R&D programs towards regulatory approvals, support upcoming product launches, pursue M&A opportunities, and expand our portfolio of therapies for serious and chronic diseases, while maintaining high and sustainable profitability.

For the full year 2026, Camurus anticipates product revenues in the range of SEK 2.6 to 2.9 billion, and an operating result between SEK 0.9 and 1.2 billion. These estimates do not account for revenues from license agreements for new or ongoing development programs.

Strong finish for Brixadi in the US and continued growth of Buvidal in own markets

Buvidal and Brixadi* continued to gain share across key markets. Royalties from Brixadi sales in the US increased by 47 percent (82 percent at CER) compared to the same quarter previous year and 10 percent (14 percent at CER) compared to the previous quarter. By the end of 2025, Brixadi is estimated to have captured over 30 percent of the long-acting injectable (LAI) buprenorphine segment, based on manufacturer-reported data and syndicated market estimates.¹ Furthermore, LAI formulations represent only about 10 percent of total US buprenorphine patients, suggesting substantial opportunity for broader adoption of Brixadi.

Full year Brixadi royalties grew 87 percent (113 percent at CER) to SEK 396 million compared to the prior year. Based on the strong market performance we anticipate continued robust growth in 2026.

Reported sales of Buvidal declined in the fourth quarter, primarily due to FX rates and a repurchase of inventory. This impact was further compounded by ongoing funding delays of opioid depen-dence treatment in England. Aside from this, underlying growth remained robust across all our markets, with 3,000 new Buvidal patients added during the quarter. By year-end, an estimated 70,000 individuals were receiving Buvidal treatment across markets. Aside from the UK, major markets such as Australia, Germany and the Nordics grew about 20 percent in the fourth quarter year-over-year, and we are optimistic about the prospects for continued robust double-digit growth in 2026 and beyond, driven by continued market penetration and expansion. The vision is 100,000 patients in treatment with Buvidal by the end of 2027. To achieve this, our teams are collaborating with stake-holders in healthcare, criminal justice and governments. Based on the growing evidence base and positive socioeconomic analyses supporting the utilization of Buvidal, we note large interest amongst key stakeholders to establish sustainable funding solutions to significantly enhance patient access to treatment with LAI buprenorphine. Discussions in this regard are currently ongoing in the UK and France.

Promising start of the launch of Oczyesa

Following market approvals of Oczyesa in Europe, the commercial launch was initiated in Germany in November 2025. The product has been well received, with significant interest from both prescribers and patients in switching from current standard of care to Oczyesa. Initial sales reached one million SEK, and at year-end approximately 20 patients were receiving treatment with Oczyesa, representing about one percent of patients treated with a somatostatin analogue for acromegaly in Germany. Given the positive start, we expect this to grow to a double-digit market share in Germany by the end of 2026.

The strong initial performance of Oczyesa indicates good prospects for further expansion in Europe, and a successful launch in the US later this year. Preparations for forthcoming launches in the UK, Sweden and Norway are well underway. It is expected that pricing approvals and product access will be secured in the coming months. Beyond acromegaly, there exists a sizable market potential for Oczyesa and Oclaiz in gastroenteropancreatic neuro-endocrine tumors (GEP-NET).

NDA for Oclaiz under review by the US FDA and SORENTO advancing in GEP-NET

Alongside the marketing progress, we continued to advance our R&D development programs for the octreotide subcutaneous depot (CAM2029) targeted at treating acromegaly, GEP-NET, and polycystic liver disease (PLD).

Acromegaly: Following market approvals of Oczyesa for the treatment of acromegaly in the EU and the UK, an updated New Drug Application (NDA) for Oclaiz** was finalized and submitted to the US FDA on 10 December, 2025. The Agency accepted the application as a Class 2 resubmission with a PDUFA action date set for 10 June, 2026, and the review is ongoing. Meanwhile, our medical and commercial teams are gearing up for an anticipated US launch shortly thereafter. Activities include evidence sharing through presentations and symposia at key scientific and medical endocrinology conferences, including AACE in Las Vegas in April, ECE in Prague in May, and ENDO in Chicago in June.

GEP-NET: SORENTO, the largest randomized Phase 3 study to date in GEP-NET, continued to progress according to plan during the quarter. The study is designed to demonstrate superior progression free survival (PFS) for GEP-NET patients treated with CAM2029 compared with standard-of-care long-acting somatostatin analogues. Key secondary endpoints include overall survival, use of rescue medication for symptoms, and multiple patient-reported outcome measures. The core phase of the study is expected to be completed in the second half of the year.

Based on the progress to date, we are optimistic about achieving the primary endpoint. The scientific rationale for SORENTO was also recently discussed in a dedicated scientific symposium at the North American Neuroendocrine Tumor Society (NANETS) meeting in October 2025.

PLD: After the randomized part of the POSITANO study was completed, with positive topline results, eligible participants continued treatment with CAM2029 in a 2.5-year long extension study, with the first participant now having completed the full study period. In parallel, preparations progressed for an advisory End-of-Phase 2 meeting with the FDA to discuss the design of a Phase 3 registrational study for CAM2029 in PLD. The meeting has been scheduled for March 2026.

Promising clinical results with monthly semaglutide and progress in strategic partnerships

In the fourth quarter, we made significant progress in the early-stage R&D pipeline, including advancement of a proprietary monthly formulation of GLP-1 receptor agonist semaglutide (CAM2056). A Phase 1b study was completed evaluating CAM2056 head-to-head against the currently available weekly formulation, Wegovy. The study enrolled a total of 80 participants with overweight or obesity who were otherwise healthy. Topline study results were announced in November and exceeded expectations, showing that CAM2056 achieved more rapid and greater reductions in body weight and blood glucose than Wegovy, with a similar tolerability and safety profile. Based on the encouraging Phase 1b results, we are preparing for the start of a clinical Phase 2b study of CAM2056 later this year. In parallel, we are developing the final product presentation, including a new auto-injector pen, for the start of a planned Phase 3 study.

In addition to CAM2056, our partnership with Eli Lilly is pro-gressing as planned to develop new long-acting incretin therapies. The programs focus on dual receptor agonists that target GLP-1 and glucose-dependent insulinotropic polypeptide (GIP), as well as triple agonists that affect GLP-1, GIP, and glucagon, all utilizing our FluidCrystal® technology. Eli Lilly also has an option to extend the collaboration to include amylin receptor agonists.

During the fourth quarter we also entered a collaboration and license agreement with Gubra to develop a long-acting treatment for hypoparathyroidism, where Gubra’s proprietary parathyroid hormone (PTH) analogues, developed using the company’s pro-prietary streaMLine peptide discovery platform, are combined with Camurus’ FluidCrystal drug delivery technology to enable extended, patient-friendly dosing. Preclinical collaboration data are promising, and we look forward to advancing this opportunity with Gubra. Camurus will develop and commercialize the product, and Gubra has an option to co-finance development.

Sustainability and organizational development

We continue our efforts to enhance the sustainability framework across the value chain. In November, Camurus achieved the highest certification level, Green, from My Green Lab. This initiative is widely regarded as the gold standard for sustainable laboratory practices and the accomplishment underscores our commitment to reducing environmental impact and promoting sustainable science within our daily operations.

Solid foundation for a potentially transformative 2026

Camurus made meaningful progress in the fourth quarter. More patients were treated with Buvidal and Brixadi, Oczyesa was launched in Germany, Oclaiz is under FDA review, and major clinical development programs advanced. The SORENTO study of CAM2029 continued to progress in GEP-NET, and CAM2056 demonstrated compelling Phase 1b results in individuals with overweight or obesity. In addition, Camurus entered a licensing partnership with Gubra for long-acting PTH agonists for the treat-ment of hypothyroidism, leveraging the FluidCrystal technology platform.

Financial results were mixed, with strong full-year growth but a dip in quarterly revenues due to currency effects and a change in the UK distribution model. We also launched a new product and expanded our R&D pipeline. Importantly, we continued strength-ening our financial position and have established a robust founda-tion for what could become a transformative 2026.

We look forward to continued growth of our core business, new regulatory approvals and launches of Oclaiz and Oczyesa in acromegaly, completion of SORENTO in GEP-NET, and initiation of a Phase 2b study with CAM2056 in obesity and overweight, along-side progress in our strategic partnerships. Business development and targeted M&A initiatives may further strengthen and diversify our product portfolio.

The progress shows Camurus ’ commitment to advancing innovative therapies that address unmet medical needs and improve outcomes for people living with serious and chronic diseases. Based on the positive development and the drive and dedication of our employees, I look forward to a productive 2026.

Fredrik Tiberg

President and CEO

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