Camurus had a successful second quarter with strong financial results and progress in our development portfolio. Total revenues increased by 52 percent to a record turnover of SEK 676 million, and operating profit amounted to SEK 292 million. Oczyesa® (CAM2029) received a positive CHMP opinion, which was followed by an approval in the EU for the treatment of acromegaly. Positive results were obtained from the POSITANO study of CAM2029 in patients with polycystic liver disease. Furthermore, we entered into a collaboration and license agreement with Lilly for the development and commercialization of long-acting incretins based on our FluidCrystal® technology platform.

Positive financial development and strong cash flow

In the second quarter, total revenues increased by 52 percent to SEK 676 million, including an initial license revenue from the partnership with Lilly of USD 12 million. Operating expenses amounted to SEK 343 million, of which research and development expenses accounted for SEK 151 million. Profit before tax was SEK 307 million, representing a 195 percent increase compared with the previous year. Cash flow for the quarter was strong at SEK 470 million. At the end of the period, cash and cash equivalents totaled SEK 3.3 billion, further strengthening our position for continued expansion, business development, and investments in the development portfolio.

Total revenues in the first half year were SEK 1,234 million, up 48 percent versus last year. The profit before tax amounted to SEK 561 million, aligned with our full-year financial outlook.

Increased market share for Buvidal® in Europe and Australia

Sales of Buvidal in our markets in Europe, Australia, and the MENA region totaled SEK 470 million, representing a 17 percent increase compared to last year (26 percent at CER). Compared to the previous quarter, growth was 3 percent at CER; -3 percent at the reported rate due to currency exchange headwinds. Australia, Spain, and the Nordics led the growth. Buvidal sales for the first half of the year totaled SEK 954 million, representing a 25 percent increase compared to last year (28 percent at CER). At the end of the period, the number of patients treated with Buvidal was estimated at around 65,000.

Alongside existing markets, the launch of Buvidal in Portugal was commenced during the quarter.

Renewed growth for Brixadi® in the US

In the US, our license partner Braeburn reported increased sales of Brixadi*, resulting in a royalty payment of SEK 89 million for the second quarter. This corresponds to a net sales growth of 100 percent (131 percent at CER) on an annual basis and 21 percent compared with last quarter (32 percent at CER). Meanwhile, the oral buprenorphine market for the treatment of opioid use disorder declined by 5 percent.¹ The renewed growth indicates that the impact of federal budget cuts and seasonal renewals of prescription authorizations, along with the unwinding of Medicaid’s continuous enrollment condition in the first quarter, has subsided. Braeburn expects continued growth of Brixadi sales in the second half of the year. This positive trajectory forms the basis for Camurus’ financial outlook for the full year 2025.

Additionally, we continued to strengthen the scientific evidence base for Buvidal and Brixadi. New results from England highlight the benefits of long-acting buprenorphine, such as greater autonomy, reduced stigmatization, and improved treatment adherence.² A study in Australia shows reduced withdrawal symptoms when discontinuing Buvidal compared with daily medication³, and a study in Scotland shows high patient satisfaction, improved adherence, and reduced use of healthcare resources in the criminal justice system.⁴ New data for Buvidal and Brixadi were also presented at several international conferences during the period.

EU approval for Oczyesa in patients with acromegaly and positive Phase 2b results from POSITANO

During the quarter, significant progress was made for octreotide subcutaneous depot (CAM2029) in the target indications: acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD).

In the acromegaly program, a positive opinion was received from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), followed by an approval by the European Commission for Oczyesa (CAM2029) for maintenance treatment of adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogs.⁵ Oczyesa is the first subcutaneous monthly treatment with octreotide for the treatment of acromegaly. It is designed for convenient self- administration by patients using a pre-filled autoinjector pen.

The approval of Oczyesa is based on results from an extensive clinical program comprising seven clinical studies, including two Phase 3 studies within the ACROINNOVA program. The studies have shown that CAM2029 provides effective biochemical control and contributes to long-term improvement in symptoms and increased quality of life compared with the current standard treat- ment with first-generation somatostatin analogs. The safety profile of CAM2029 was comparable to standard treatment with no new or unexpected findings.

During the period, we also received positive results from an extension study to ACROINNOVA 2, showing sustained and improved treatment efficacy with CAM2029 versus standard of care at baseline. Reinvited patients also showed improvements in biochemical control when switching from an intermittent period on standard of care to CAM2029.

Launch preparations for Oczyesa and stakeholder engagement in the first EU markets are well underway, and the product will be available to patients early in the fourth quarter.
An updated new drug application (NDA) is ready to be submitted to the US FDA in the third quarter, awaiting the conduct of a recently announced routine GMP inspection at the contract manufacturer’s site.

In the PLD program, we received positive primary results from the Phase 2b POSITANO study, which randomized 71 patients with symptomatic PLD to treatment with CAM2029 in two different dose groups or to placebo.

POSITANO met its primary endpoint, showing that CAM2029 reduces the growth of liver and cysts compared to placebo.

Furthermore, CAM2029 resulted in improvements in disease symptoms and other patient- and clinician-reported outcome measures during the treatment period. CAM2029 demonstrated a safety profile comparable to the established safety profile of first-generation somatostatin analogs (octreotide or lanreotide) for injection. The most common adverse events reported were gastrointestinal effects and injection site reactions of mild or moderate intensity. Based on the results from POSITANO, Camurus plans to meet with the FDA to discuss the design of a confirmatory Phase 3 study.⁶

Following completion of the randomized phase of POSITANO, treatment of remaining patients with CAM2029 will continue in an open-label 2.5-year extension phase to evaluate long-term safety and efficacy.

In the GEP-NET program, treatment progressed in the global randomized, active-controlled Phase 3 study, SORENTO, evaluating progression-free survival with CAM2029 compared to current standard of care. The study is progressing according to plan, and the randomized part of the study is expected to be completed in the early part of 2026.

In addition, we progressed the work to establish a US manufacturer for CAM2029 and expect to commence GMP manufacturing in the second half of this year.

Clinical study of semaglutide monthly depot and new agreement with Lilly for long-acting incretins

During the quarter, we also advanced the randomized, active- controlled Phase 1 study of semaglutide monthly depot (CAM2056) in participants with overweight or obesity. A total of 80 participants, divided into five dose groups with CAM2056 and one dose group with active control (Wegovy®), have been included in the study. Overall results from the study are expected in the fourth quarter.

A new collaboration and license agreement with Lilly was announced for the development and commercialization of long-acting incretin medicines based on our FluidCrystal tech- nology platform and up to four of Lilly’s active pharmaceutical ingredients. The partnership strengthens our presence in rapidly growing disease areas such as obesity and type 2 diabetes, while maintaining our commercial focus on rare and CNS diseases. The license agreement covers long-acting formulations of dual GIP and GLP-1 receptor agonists, triple GIP, glucagon, and GLP-1 receptor agonists, as well as an option for amylin receptor agonists based on FluidCrystal. Under the agreement, Camurus is entitled to payments of up to USD 870 million in development and sales-related milestones. In addition, the company is entitled to mid-single-digit percentage royalties on product sales under the agreement.

New members of Camurus’ board and management team

At the annual general meeting in May, Elisabeth Björk and Robert McQuade were welcomed as new members of Camurus’ board of directors. They bring extensive international expertise and experience in drug development and business development.

In the management team, Anders Vadsholt has been named as our new Chief Financial Officer (CFO), succeeding Jon Garay Alonso. Additionally, Susanne Lagerlund was appointed Vice President, Technical Operations, taking over the responsibility for process development, manufacturing, and quality from Torsten Malmström.

Good prospects for a successful second half of the year

Camurus delivered a solid second quarter marked by continued growth, strong cash flow, and progress in both the development portfolio and within business development. Sales of Brixadi gained new momentum in the US, Oczyesa was approved in the EU, and we received positive clinical results from the POSITANO study in patients with PLD. The agreement with Lilly for the development and commercialization of long-acting incretin medicines for cardiometabolic diseases was another strategically important milestone with significant future revenue potential for Camurus.

In summary, we had an excellent first half of the year, achieving important milestones. We look forward to new highlights in the second half and continued progress towards our 5-year vision for 2027.

Finally, I want to thank our employees and teams for significant achievements during the quarter.

Wishing everyone a nice summer.

Fredrik Tiberg

President and CEO

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