Camurus ended 2024 with a very solid fourth quarter, growing 48 percent year on year, driven by increasing Buvidal® sales and royalty revenues from Brixadi® in the US. Due to strong financial performance, results for the quarter and full year exceeded previous estimates. In the development pipeline, a Complete Response Letter (CRL) was issued by the FDA for the CAM2029 New Drug Application for acromegaly in the US, solely related to observations during a cGMP inspection at a third-party manufacturer. The Marketing Authorization Application for CAM2029 in the EU progressed according to plan during the quarter, alongside pivotal clinical studies of CAM2029 in neuroendocrine tumors and polycystic liver disease. In the early pipeline, a clinical study of our monthly semaglutide depot (CAM2056) was initiated in participants with overweight or obesity.

Increased growth and continued trend in positive results

In the fourth quarter, we continued to deliver on our strategic objectives and our 2027 vision, with strong growth and record result from ongoing operations. Total revenues during the quarter amounted to SEK 553 (375) million, corresponding to 48 percent growth on an annual basis and 15 percent over the quarter. Operating expenses for the period were SEK 357 million with savings relating to postponement of the launch of Oclaiz™* in the US and decreased social security costs for the company’s long-term incentive program. Profit before tax for the quarter increased SEK 204 million to SEK 186 (-18) million.

For the full year, Camurus’ total revenues amounted to SEK 1,868 million, in the top range of the raised financial outlook from 7 November 2024. Operating expenses were SEK 1,257 (1,069) million. Research and development costs amounted to SEK 684 million, in line with previous estimates plus incremental expenses of SEK 20 million for the development and preparation for the start of a Phase 1 clinical study of CAM2056. Profit before tax for the full year was SEK 553 million and exceeded previously communicated estimates, driven by robust revenue generation combined with controlled operating expenses. Cash flow from operating activities for the full year was SEK 593 million, and cash at year end amounted to SEK 2.9 billion, with no debt. All in all, we continue to strengthen our financial position to execute on our strategy for continued growth and value creation through increased sales, investments in our pipeline, and business development.

Accelerated sales of Buvidal and increased royalty revenues from Brixadi in the US

Sales of Buvidal, for the treatment of opioid dependence, amounted to 469 million in the quarter, a growth of 28 percent year-on-year and 11 percent compared to previous quarter. The number of patients treated with Buvidal increased by over 4,000 in the quarter to an estimated 60,000 at the end of the year. For the full year 2024, sales were SEK 1,654 million, an increase of 27 percent compared to last year.

Growth during the quarter was strong in Europe, where Buvidal continued to gain market share in major markets such as the UK, Germany, Spain and France. In addition to continued market penetration, market access was expanded with new price and reimbursement approvals in Switzerland, Portugal and Luxembourg. Launches in these markets are scheduled for early 2025. Buvidal continued to grow in Australia and is now first choice for treatment of opioid dependence with more than one quarter of total patients and a market share in the long-acting buprenorphine segment of over 80 percent. An important initiative in improving access to Buvidal for patients has been the development of a pharmacy administration model to complement administration at specialty clinics and relieve their workload. At the end of 2024, there were already more than 200 pharmacies around Australia that offered administration of Buvidal. In addition to giving patients greater flexibility, this has contributed to increased treatment capacity and more patients in treatment.

In the US, royalty revenues from the sales of Brixadi** amounted to SEK 83 million in the quarter, which corresponds to a sales increase of 43 percent compared to previous quarter. Overall, Brixadi had a strong first full year on the US market in 2024, far surpassing previous product launches in this segment. Total royalty revenues for the year were SEK 212 million, an increase of SEK 203 million. The equalized monthly prescriptions share of Brixadi at the end of the fourth quarter approached 25 percent of the US buprenorphine long-acting prescription market.¹

In parallel with the strong commercial performance, we continued growing the evidence base for Buvidal and Brixadi with new results presented at scientific meetings and in journal publications, including new quantitative data on illicit opioid use indicating enhanced treatment efficacy with Buvidal compared to daily administered sublingual buprenorphine in patients with high levels of illicit opioids.² In 2025, we look forward to results from several ongoing clinical studies, including large Investigator Sponsored Studies being completed in the US and Europe.

Regulatory applications for CAM2029 in acromegaly and advanced clinical studies in NET and PLD

Long-acting octreotide (CAM2029) is being developed for the treatment of rare, severe, and chronic conditions, including acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD).

Acromegaly. In the quarter, a Complete Response Letter (CRL) was received from the FDA for the New Drug Application (NDA) for CAM2029 for the treatment of acromegaly. The CRL solely related to observations during a cGMP inspection at a third-party contract manufacturer, which the manufacturer responded to during the period. The manufacturer is awaiting an establishment inspection report to assess any need for further remediations following a recent official action indicated (OAI) classification for the site. This will inform the timing of the resubmission of the CAM2029 NDA to the FDA, currently estimated to the first half of 2025. In parallel with activities in the US, the corresponding Marketing Authorization Application (MAA) in the EU progressed according to plan and a recommendation for market approval is expected around mid-2025. In addition to the regulatory procedures, launch preparations have been continuing, including advisory meetings with healthcare providers, payers and patients, in-depth market research, and further development of the supply chain. Thus, we are well prepared for upcoming launches, with key commercial functions in place in both the US and the EU.

Additionally, key results from our Phase 3 ACROINNOVA 1 study were published in the Journal of Clinical Endocrinology & Metabolism (JCEM) during the quarter.³

GEP-NET. Treatment of patients progressed in the pivotal, global, Phase 3 study SORENTO, evaluating increased progression-free survival (PFS) with CAM2029 compared to standard of care treatment in patients with GEP-NET. During the quarter, the estimated study timeline to end the randomized part of the study was updated to late 2025 or early 2026, based on a lower rate of PFS events, i.e. death or tumor progression, than estimated for the patient population in SORENTO, of whom the majority had advanced disease of grade 2 or 3 at study entry. Overall, SORENTO continued to progress well thanks to our many engaged and dedicated investigators, clinical team members, contract research staff, and most importantly all the patients participating in the study. The feedback from SORENTO continues to be very positive and we look forward to the continued development and outcome of the study.

PLD. During the quarter, the POSITANO study of CAM2029 in patients with symptomatic PLD has progressed, and most patients have now completed the randomized, double-blind treatment period of the study and moved into the extension phase. The last patients are expected to complete the core phase of the study in the first quarter of 2025 and primary results are expected the following quarter. PLD is a rare and serious chronic disease with no approved medical treatments. Alongside the progress of POSITANO, CAM2029 was granted Orphan Drug Designation for the treatment of autosomal dominant PLD by the European Commission in the quarter.

Start of new clinical study of semaglutide monthly depot

During the quarter, we received clinical trial authorization for the start of a randomized, active-controlled Phase 1 study of semaglutide monthly depot (CAM2056) in participants with overweight or obesity, who are otherwise healthy. The study, evaluating pharmacokinetics, pharmacodynamics – including weight loss – and safety of repeated dosing of CAM2056 compared to semaglutide weekly injection (Wegovy), was initiated during the period. Treatment of the first randomized cohorts is ongoing and study results are expected in the second half of 2025.

In addition to CAM2056, we have advanced several other promising product candidates through early development and assessments in preclinical studies, including different long-acting incretins.

Company expansion and new headquarters with laboratory in Lund

During the quarter, our new headquarters and laboratory were completed in Science Village in Lund, in between the Max IV synchrotron and the European Spallation Source neutron facilities. In addition to enabling further expansion of our business, the move is a major boost to our research activities, with efficient, state-ofthe-art laboratories designed for our development operations. In parallel, we have completed our Camurus Inc. office at Carnegie Center, Princeton, New Jersey, where we continue to establish our commercial organization and prepare for the planned launch of Oclaiz™ and other innovative products designed to improve the lives of patients with severe and chronic disease.

Strong end to the year lays the foundation for Camurus’ expansion in 2025

Camurus had an excellent finish to the year with strong growth and high profitability. Sales of Buvidal grew by double digits over the quarter, as did royalty revenues from the sales of Brixadi in the US. Overall, during the year, we delivered a strong performance and a result before tax well above previous estimates. Our cash position was strengthened to SEK 2.9 billion, supporting future investments in planned launches, acquisitions or in-licensing, as well as expansion of our manufacturing capacity and product portfolio.

The financial outlook for 2025 includes a revenue growth of 45 – 61 percent to between SEK 2.7 and 3 billion, primarily driven by Buvidal and Brixadi with a small revenue contribution from the anticipated launch of Oclaiz™ in acromegaly and partnerships. Profit before tax for 2025 is expected in the range of SEK 0.9 – 1.2 billion. Investments in research and development remain unchanged at the 2024 level. We continue to deliver in accordance with our five-year vision including the targets of five-fold revenue growth compared to 2022 and reaching an operating margin of around 50 percent in 2027.

In 2025, we look forward to anticipated market approvals for CAM2029 in the US and EU in acromegaly and clinical results from CAM2029 in PLD, POSITANO, and from our recently started clinical study of CAM2056 in participants with overweight or obesity. Additional opportunities include reaching the target for the readout of primary data for the SORENTO study in GEP-NET and business development.

Lastly, I would like to thank our employees, board members and collaborators for your efforts and excellent performances during the year and our shareholders for your continued support.

Fredrik Tiberg

President and CEO

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