Camurus had a robust third quarter with increased revenues and high profitability. Royalties from the sales of Brixadi®* in the US contributed to growth, while the performance in Europe was weaker. Oczyesa® received a second regulatory approval for the treatment of acromegaly, and was recently launched in Germany as the first market in Europe. The NDA for Oclaiz™** in the US is ready for resubmission to the FDA, pending completion of an ongoing inspection at the contract manufacturer. Within our development portfolio, the Phase 3 study SORENTO of CAM2029 progressed in patients with neuroendocrine tumors alongside a Phase 1b study of CAM2056, semaglutide monthly depot, in participants with overweight or obesity. Topline results for CAM2056 are expected shortly.

Full-year 2025 revenue guidance adjusted

Third quarter revenues increased by 18 percent year-on-year to SEK 567 million, driven by higher royalty income from Brixadi in the US. The profit before tax rose to SEK 245 million, an increase of 48 percent. Operating expenses remained unchanged at SEK 298 million, demonstrating continued cost discipline and alignment with updated timelines for the planned launch of Oclaiz in the US.

During the first nine months, revenues increased by 37 percent to SEK 1,801 million. Despite the strong growth, this is slightly below expectations, mainly due to a temporary slowdown for Buvidal® in the third quarter and overall lower than forecasted revenues from the sales of Brixadi in the US. Operating expenses were maintained at the same level as in Q3 2024, and profit before tax increased by 120 percent to SEK 806 million. The profit margin year to date is 45 percent, and the cash position grew to SEK 3.5 billion.

Given the lower-than-expected revenue performance relative to our full-year outlook and the potential delay of a milestone payment associated with the sales of Brixadi in the US, the company has revised its revenue forecast to a range of SEK 2.3 to 2.6 billion. The guidance for profit before tax remains at SEK 0.9 to 1.2 billion.

We continue working and remain committed to achieving the objectives outlined in Camurus’ Vision 2027. 

Slower quarter for Buvidal in Europe

Buvidal sales in Europe, MENA, and Australia amounted to SEK 455 million this quarter, reflecting 8 percent year-over-year growth (15 percent at CER), though down 3 percent from the previous quarter. The decline mainly results from ongoing delays in allocation of committed Government funding1 to UK clinics, which also affects distributor inventories. Nonetheless, in-market growth remained positive at approximately 3 percent across our regions. Growth was modest in Germany but robust in Australia, Norway, Spain, and France.

There is a significant demand for Buvidal among patients and treatment providers, with many people waiting for treatment, and we see an increased stakeholder interest and engagement in providing patients with improved access to long-acting therapies for opioid dependence. Our teams are actively driving several initiatives to improve access to treatment, including raising awareness of the key benefits of treatment for individuals, healthcare providers, and society at large, as well as developing strategies to address funding issues and delays in the allocation of funds to treatment centers.

The evidence base for Buvidal continues to expand, and economic models indicate that Buvidal can contribute to significant cost savings in health and correctional care and society at large. We are optimistic about renewed short- and medium-term growth based on ongoing discussions.

Positive trend for Brixadi in the US

In the US, our royalty income from Braeburn’s sales of Brixadi for the treatment of opioid use disorder (OUD) increased by 91 percent (100 percent at CER) on an annual basis to SEK 111 million. Compared to the previous quarter, there was a 25 percent increase (20 percent at CER). The sustained growth in the third quarter reflects the competitive product profile of Brixadi and Braeburn’s progress in navigating operational challenges.

The long-acting injectable OUD market has grown 25 percent this year compared to the same time period last year2, and now accounts for approximately 8 percent of total buprenorphine patients. In this segment, Brixadi is now estimated to have reached a patient share of close to 30 percent. Nevertheless, the primary opportunity for market expansion remains the conversion of patients from daily sublingual buprenorphine products.

Sales growth is expected to continue in the fourth quarter; however, total revenues for 2025 are projected to fall short of our full-year prognosis due to lower than expected royalty income and the possible postponement of an anticipated milestone payment to 2026. Overall, we remain optimistic about the prospects for Brixadi in the US and the potential for significant growth in the coming years.

Preparations for Oczyesa (CAM2029) launches following regulatory approvals for acromegaly

During the quarter, the development of the octreotide subcutaneous depot (CAM2029) continued for the treatment of three chronic diseases: acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD).

Acromegaly: Following the approval of Oczyesa for the treatment of acromegaly in the EU and the UK, the focus has been on market preparation efforts. Oczyesa is now launched in Germany, with an estimated 2,000 to 3,000 patients in medical treatment for acromegaly, of which about two thirds are potential candidates for treatment with Oczyesa. After Germany, further launches are planned in the coming quarters. Oczyesa is the first monthly subcutaneous treatment with octreotide that can be easily administered by the patient using a pre-filled autoinjector pen, and feedback on the product profile, including clinical efficacy and safety data, is consistently positive.

Alongside our European efforts, the NDA for Oclaiz in the US has been updated and will be resubmitted after satisfactory completion of the ongoing inspection at the contract manufacturer. We anticipate an approval decision during the first half of 2026, and US market preparations are well underway to support a timely launch of Oclaiz in acromegaly following FDA approval.

GEP-NET: During the period, SORENTO, the largest randomized phase 3 study to date in GEP-NET, continued, including a total of 332 enrolled patients with metastatic or locally advanced disease of grade 1–3. Unlike previous Phase 3 studies, CLARINET3 and PROMID4, SORENTO has an active control arm and more patients with advanced disease (grade 2 and 3). The study is designed to demonstrate a 35 percent treatment difference in progression-free survival (PFS) in favor of CAM2029 compared to standard treatment with first-generation long-acting somatostatin receptor ligands, lanreotide and octreotide. The primary results from SORENTO are evaluated after 194 PFS (tumor progression or death) events have been verified via blind, independent assessment (BIRC). We currently expect to reach the target number of events to read out the primary results mid to late 2026, depending on the continued accrual rate.

We are pleased with how SORENTO is progressing and the positive indications we have for the treated study population. SORENTO was recently discussed at a scientific symposium at the North American Neuroendocrine Tumor Society (NANETS) with very encouraging reception from treaters of neuroendocrine disease as well as patient advocacy representatives. Positive outcomes from the SORENTO study are anticipated to change the treatment paradigm and establish CAM2029 as the standard of care for many patients with GEP-NET.

PLD: The 30-month extension part of the Phase 2b study POSITANO is now underway, following the positive primary outcomes announced earlier in the year. In parallel, preparations are underway for an advisory End-of-Phase 2 meeting with the FDA to review the ongoing development strategy for CAM2029 in PLD. During the period, CAM2029 also received orphan drug designation for the treatment of an additional indication, polycystic kidney disease, from both the FDA and the European Commission.

Advances in the early research portfolio of long-acting incretin drugs

The randomized Phase 1b study comparing our semaglutide monthly depot (CAM2056) to the current weekly formulation in participants with overweight or obesity, has been completed during the period. Topline results are expected shortly.

During the quarter we also initiated our strategic collaboration with Eli Lilly, which we entered into at the end of Q2, regarding the development of other long-acting incretin drugs, specifically dual GLP-1 and GIP receptor agonists and triple agonists for GLP-1, GIP and glucagon receptors based on the FluidCrystal® technology. In addition, Lilly has an option for amylin receptor agonists.

Sustainability and organizational development

Camurus has made considerable progress in its sustainability efforts, as evidenced by improved ratings in external ESG assessments. In the quarter, Sustainalytics revised Camurus’ risk classification from medium to low in relation to the financial impact of ESG factors. Additionally, we submitted our first report to the Carbon Disclosure Project (CDP) and continued the certification process of our laboratories under the My Green Lab standard.

During the period, our regular employee survey was also conducted with highly positive outcomes. The Employee Net Promoter Score (eNPS) reached 69, positioning Camurus within the top five percent of highest-ranked companies in the pharmaceutical sector.

Positive outlook on Camurus’ continued development and value creation for patients

Camurus reported a stable third quarter, characterized by strong financial results, increased revenues, and the approval of a new product. In the opioid dependence treatment segment, Brixadi sales in the US demonstrated recovery after a slow start earlier this year. For Buvidal, our commercial teams are actively implementing strategies to address market challenges in Europe resulting from funding delays and healthcare austerity measures. Despite these obstacles, underlying demand for our treatments remains positive, and we maintain a positive outlook for sustained growth. Additionally, we remain optimistic regarding the forthcoming launches of Oczyesa/Oclaiz in Europe and the US over the next several quarters. Our pipeline continues to advance, with topline results anticipated for CAM2056 semaglutide monthly depot in November, and for CAM2029 in GEP-NET in 2026.

These developments support our ongoing efforts to develop innovative therapies aimed at addressing unmet medical needs and improving outcomes for patients with severe and chronic diseases.

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