Camurus has had another good quarter with strong financial performance and positive operational development. Sales of Buvidal and Brixadi continued to grow, resulting in our best result to date, excluding one-time revenues. Our pipeline progressed well with positive Phase 3 results from the ACROINNOVA 2 study, confirming the long-term safety profile and efficacy of CAM2029 in patients with acromegaly. In parallel, our clinical studies of CAM2029 for the treatment of neuroendocrine tumors and polycystic liver disease advanced. In the US, the FDA continued its review of our new drug application for CAM2029 in acromegaly. After the quarter, a Complete Response Letter was received from the Agency, solely relating to a cGMP-inspection at a third-party manufacturing site and pending issuance of an inspection classification.

Increased revenues and strong financial results

In the third quarter, total revenues increased by 25 percent (26 percent at CER) to SEK 480 million compared to last year. Excluding one-time revenues in 2023, the increase was 38 percent (41 percent at CER). Operating expenses during the period were SEK 304 million, of which SEK 163 million were investments in research and development. Profit before tax was SEK 165 million; Camurus’ best result to date from operating activities, excluding one-time revenues.

For the first nine months of 2024, total revenues were SEK 1,314 million, an annual increase of 40 percent excluding one-time revenues related to the approval of Brixadi in 2023. Profit before tax was SEK 366 million, an increase of 127 percent compared to the same period of the previous year, excluding one-time revenues. R&D investments during the same period were SEK 516 million.

Based on the positive development and expectations for the fourth quarter, we have raised our full year 2024 outlook for total revenues to SEK 1,810–1,880 million and profit before tax to SEK 450–510 million, see page 16.

Cash flow from operating activities was SEK 133 million in the third quarter and SEK 427 million in the first three quarters of the year. At the end of the third quarter, Camurus’ cash position was SEK 2.75 billion and the company had no debt.

Globally leading position in long-acting treatment of opioid dependence with Buvidal and Brixadi

Sales of Buvidal in Europe, Australia and MENA increased by 22 percent (24 percent at CER) on an annual basis to SEK 421 million. Compared with the previous quarter, the increase was 5 percent (6 percent at CER), which, when adjusted for currency, is the same growth as in the second quarter. An estimated 56,000 patients were on treatment with Buvidal at the end of the quarter, which corresponds to a net increase of over 3,000 patients.

Buvidal sales growth was evenly distributed across Europe, MENA and Australia, with no contribution from significant one-off revenues. In Europe, the positive development from the previous quarter continued in Germany and the UK, both of which are important markets with significant growth potential. In the Nordics, Spain and France, growth was softened due to reduced patient recruitment during the holiday season. In Australia, the implementation of previously communicated changes to distribution, payment and reimbursement systems caused some variations in stock levels and reported sales in the quarter, which have now stabilized.  The implemented changes are overall positive for Australian patients with opioid dependence, who now have increased access to treatment and reduced costs for medication administration.

In the US, sales of Brixadi* for the treatment of opioid use disorder (OUD) grew by 39 percent at CER (30 percent at reported rate) compared to the previous quarter, resulting in SEK 58 million in royalty to Camurus. The majority of new patients have come from previous treatment with sublingual buprenorphine products, which represents about 90 percent of the current OUD patient population in treatment.¹ New prescriptions increased in September, and we expect robust sales growth in the fourth quarter. Braeburn has established broad access to treatment with Brixadi. With more than 6 million people with OUD in the US, of whom about 2 million are estimated to be on treatment for OUD^2-4, there are clear opportunities to meaningfully contribute to reducing the consequences of this major public health crisis in the US.

Several publications on the use of Buvidal and Brixadi were published during the quarter. This includes the evaluation of long-acting buprenorphine in emergency care units and a study comparing depot treatment with sublingual buprenorphine upon release from prison.5,6 In addition, Camurus participated in presentations at several national and international scientific conferences. We continue to receive positive feedback from the market, exemplified by recent reports in British media featuring patients and decision makers that show how Buvidal can contribute to improved quality of life for patients and potential significant cost-savings for society.⁷

Continued clinical progress with octreotide subcutaneous depot (CAM2029)

We continued to advance our octreotide subcutaneous depot (CAM2029) development in acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD) during the quarter.

Positive Phase 3 data for CAM2029, followed by a Complete Response Letter from the FDA

In July, we received positive Phase 3 results from the ACROINNOVA 2 study in 135 patients with acromegaly.⁸ The results confirmed previous data regarding the safety profile and long-term efficacy on the disease marker insulin-like growth factor-1 (IGF-1). The proportion of patients with controlled IGF-1 levels increased significantly with CAM2029 compared to treatment with previous standard of care. In the total population, the increase was 12.7 percent (95%CI: 5.5; 19.9) and in the group of new patients it was 22.8 percent (95%CI: 11.6; 33.9). In addition, reduced disease symptoms, increased treatment satisfaction, and improved quality of life were observed after treatment with CAM2029 compared to standard treatment at the start of the study.

In parallel, the US Food and Drug Administration (FDA) review of our new drug application (NDA) of CAM2029 in acromegaly progressed. Following late-stage labeling discussion, Camurus received a Complete response Letter (CRL) on the 21 October PDUFA action date. This exclusively referred to observations made during a recent good manufacturing practice (cGMP) inspection at a third-party manufacturer’s facility. The manufacturer has responded to all observations and is awaiting an inspection classification by early December 2024. Assuming a positive outcome. Camurus will then resubmit the NDA to the FDA for review. Depending on if it is assessed as a Class 1 or Class 2 resubmission, a two or six months review period is expected. In parallel with the NDA process, a market authorization application (MAA) for CAM2029 has progressed in the EU, with a final recommendation from the European Medicines Agency (EMA) expected in mid-2025.

Interactions with payers and other stakeholders, as well as various medical activities, have also been ongoing during the quarter. Data from the ACROINNOVA program has been presented at ENEA 2024 in Seville, Spain, and the Phase 3 results from ACROINNOVA 1 have recently been published in the Journal of Clinical Endocrinology & Metabolism (JCEM).⁹

In the GEP-NET program, the randomized, active-controlled Phase 3 study SORENTO has progressed towards the goal of demonstrating whether treatment with CAM2029 leads to increased progression-free survival (PFS) compared to current standard treatment with first-generation somatostatin receptor ligands.^10,11 Since the start of the study in November 2021, the independent safety committee for SORENTO have held six data review meetings, which all have confirmed that CAM2029 has an acceptable safety profile comparable to current standard of care and with no new or unexpected observations. Recently, we have also performed an updated analysis of tumor progression events and deaths in SORENTO, indicating a longer progression free survival (PFS) and a lower event rate than expected in the study population, a majority of whom had advanced disease, GEP-NET grade 2 to 3 at the start of the study. Based on a better than expected tumor control in the study, the estimated timing for reaching the number of PFS events required for read out of primary results, has been updated from first half of 2025 to late 2025, or early 2026.

In the PLD program, POSITANO, our randomized, placebo-controlled Phase 2/3 study of CAM2029 in patients with symptomatic PLD continued to progress. Just over half of the 71 randomized patients in the study have now completed the 52-week main part of the trial and entered the extension phase. Remaining patients will have completed the main study in March 2025 and topline results are expected in the first half of 2025. During the period, the EMA issued a recommendation of orphan drug designation for CAM2029 for the treatment of patients with autosomal dominant PLD.

Clinical study of semaglutide monthly depot

During the period, preparations continued for the start of a clinical study of an internally developed semaglutide monthly depot (CAM2056). This included manufacturing of clinical trial material and the completion of study protocols. The study is a randomized, dose-escalating, multiple-dose Phase 1 study evaluating the pharmacokinetics, pharmacodynamics, and safety of CAM2056 versus weekly active comparator in participants who are overweight or obese and otherwise healthy. The study is planned to start around the turn of the year 2024/25. Development of other long-acting incretins were also progressed in formulation and non-clinical studies.

Organizational development and improved sustainability rankings

The engagement and well-being of our employees are key to Camurus’ success as a fast-growing innovative company. During the period, a new employee survey was performed with high ratings across all categories. Our employee Net Promoter Score (eNPS) was 65, which represents a further improvement compared to the previous year and is multiple times higher than the industry benchmark. This is pleasing considering the rapid international expansion of Camurus’ workforce.

The work to establish our commercial organization in the US has continued and we are well prepared for the launch of Oclaiz™** subject to FDA approval. Based on the expectations of the continued NDA process, a new PDUFA date is anticipated in the first half of 2025.

In addition, we made progress in our systematic sustainability work during the quarter, which was reflected by improved sustainability ratings from two international sustainability rankings: from A to AA (leadership position) in MSCI’s global sustainability ranking, placing Camurus among the top 20 percent of companies in the healthcare segment with the highest sustainability performance, and from 73/100 to 83/100 in the EthiFinance ranking.¹²

Excellent performance during the third quarter raised the outlook for the full year 2024

Camurus had a positive third quarter with growing revenues and profit whilst making meaningful investments in our development portfolio and commercial organization in the US. Based on the results for the first three quarters of 2024, we raised our financial outlook for revenues and profit before tax for the full year 2024. We ended the quarter with a cash position of SEK 2.75 billion for investments in upcoming launches, potential acquisitions or in-licensing of programs and strengthened of our manufacturing capacity.

The CRL from the FDA for the CAM2029 NDA for the treatment of patients with acromegaly was unexpected. However, we are optimistic that the contract manufacturer has responded satisfactorily to the CRL, and that the NDA for CAM2029 for treatment of patients with acromegaly can be resubmitted as soon as possible to the FDA for final approval. In parallel, the SORENTO and POSITANO studies in GEP-NET and PLD have progressed together with preparations for the start of a clinical study of a semaglutide monthly depot.

With continued progress and exciting developments underway, we look forward to a strong end to the year and the start of 2025, as we continue delivering on our strategic plan and 2027 vision.

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