Camurus finished the year with an excellent fourth quarter with significant growth and pipeline progress. In the US, sales of Brixadi started to take off after the launch in September, driven by a large unmet medical need for the treatment of opioid use disorder. We completed and submitted a New Drug Application to the US FDA for Oclaiz™ (CAM2029) for the treatment of acromegaly and finalized patient recruitment in the SORENTO study of CAM2029 in patients with neuroendocrine tumors. After the period, Camurus executed a directed share issue of SEK 1.1 billion to further strengthen our growth through business development and expanded launch preparations.

Strong finish resulted in record revenue for the full year 2023

During the fourth quarter Camurus’ positive development continued in our different business areas and key markets. Total revenues increased by 40 percent to SEK 375 million in the quarter, mainly driven by Buvidal® product sales and a high unmet medical need in the treatment of opioid dependence. Operating expenses increased by 67 percent to SEK 371 million in the quarter, primarily due to progress of our Phase 3 programs and completion of patient recruitment in the SORENTO study, the establishment of our US commercial organization, and accrued social security costs for employee long term incentive programs of 51 million SEK relating to the strong performance of the Camurus share during the period (+73 percent). Operating result for the fourth quarter was SEK -29 million, and cash flow, which was not affected by the social security cost accrual, was SEK 36 million.

For the full year, total revenues increased by 80 percent to SEK 1,717 million – at the high end of the range of our full-year 2023 outlook raised in October. This includes one-time milestone payments of SEK 406 million related to the Brixadi approval. Operating expenses increased by 36 percent to SEK 1,070 million, of which SEK 638 million (64 percent) represents investments in our development pipeline of innovative drug candidates. Operating result for the full year was SEK 526 million, corresponding to an operating margin of 31 percent. Profit before taxes was SEK 549 million. Camurus’ cash position at the end of the year was SEK 1 190 million, which represents an increase of SEK 624 million compared to last year.

At the beginning of 2024, our financial position was further strengthened through a successful directed share issue with gross proceeds of SEK 1 090 million. The issue was performed to expand Camurus’ ability to diversify the product portfolio through potential acquisitions of commercial products or late-stage development candidates that are complementary to our current products and pipeline. Additionally, the financing will support the advancement of the commercial preparations for CAM2029 in neuroendocrine tumors and polycystic liver disease in the US, and globally, as well as strengthen our manufacturing capabilities and secure a sustainable supply of future products. The directed share issue was conducted with strong support of new high-quality, international, specialist investors and existing shareholders.

Increased market share and improved patient access to Buvidal

People with opioid dependence are a vulnerable and stigmatized population with significant medical needs. Providing access to innovative, evidence-based treatments that can improve treatment outcomes and quality of life for people with substance use disorders is a high priority for Camurus. Through the development of Buvidal and Brixadi, weekly and monthly buprenorphine depots, Camurus has established a leading position within long-acting treatment of opioid dependence with global reach.

During the quarter, Buvidal net product sales increased by 37 percent to SEK 366 million, an increase of 6 percent compared to the previous quarter (7 percent at constant exchange rate). For the full year, net product sales of Buvidal were SEK 1 299 million, increasing 39 percent compared to 2022. We continue to see strong sales performance in key markets such as the UK, Australia and the Nordics, together with other markets such as Germany, Spain and France, growing from a lower base. The use of Buvidal has continued to increase across community and criminal justice settings, and experiences with Buvidal highlights stable efficacy, high retention, treatment satisfaction, and cost-effectiveness. In addition, Buvidal received regulatory approval in Kuwait and Buvidal 160 mg was approved in New Zealand. At the end of the quarter, about 48,000 patients were estimated to receive treatment with Buvidal.

Accelerating sales of Brixadi* in the US

Brixadi was launched in the US on 5 September 2023 for the treatment of opioid use disorder (OUD) by our licensee Braeburn. The Brixadi launch gained momentum in the fourth quarter as evidenced by the growing royalty income of SEK 8.3 million to Camurus.

The positive start is a result of the strong product profile of Brixadi, a high medical need in the US, and Braeburn’s launch strategy and execution. The messaging about Brixadi is resonating with US healthcare professionals and highlighting its’ unique product advantages. Braeburn’s market access team has achieved a wide payor coverage, which only four months into the launch is on par with another long-acting product in the segment. To provide quick and reliable access to Brixadi for patients and prescribers, a dedicated network of specialty pharmacies and specialty distributors has been established. Braeburn has a targeted approach to the launch and has identified and segmented treatment providers based on the probability that Brixadi reaches patients who benefit from the treatment early in the launch process. This has resulted in a significant uptake, enabling more patients to receive treatment for their OUD. Based on the positive start, Braeburn is optimistic that Brixadi will achieve peak year sales well over USD 1 billion. This corresponds to a market share below the one Buvidal today holds in most markets in the EU and Australia. We look forward to working with Braeburn to maximize the availability of Brixadi for patients who suffer the devastating effects of opioid use disorder.

In the quarter, we continued to grow the evidence base for Buvidal and Brixadi with several new supportive publications accepted and published during the period.^1-4 In addition, several investigator-led clinical studies of Buvidal and Brixadi are ongoing in different treatment settings and may provide further support for the use in for example emergency care after overdose events and within the correctional justice system in the US.

Oclaiz™** (CAM2029) on track for market approval

CAM2029, octreotide subcutaneous depot, is being developed for the treatment of three rare diseases: acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NET), and polycystic liver disease (PLD).

Acromegaly. Following pre-NDA meetings with the US FDA, the new drug application (NDA) forCAM2029 in acromegaly was finalized and submitted to the FDA on 21 December 2023. A response from the FDA with a target date for approval decision (PDUFA) is expected shortly.

The NDA is based on results from a 24-week, randomized, double-blind, placebo-controlled, multi-center Phase 3 study (ACRO[1]INNOVA 1) of patients with acromegaly switched to CAM2029 or placebo from a stable dose of standard treatment with octreotide or lanreotide. The NDA is further supported by interim results from a 52-week, open-label Phase 3 study (ACROINNOVA 2) of long-term safety and treatment efficacy with CAM2029 in patients with acromegaly, as well as one Phase 2 study and four Phase 1 studies.

The results from the ACROINNOVA program suggest that CAM2029, if approved, can be a significant new treatment option for patients with acromegaly that contributes to effective control of both the disease marker insulin-like growth factor 1 (IGF-1) and acromegaly symptoms. In addition, the studies indicated that patients experienced increased treatment satisfaction and quality of life after switching from current standard treatment to CAM2029. The safety profile of CAM2029 was comparable to that of approved first-generation somatostatin receptor ligands for intramuscular or deep subcutaneous injection, with no new or unexpected observations.

GEP-NET. Patient recruitment in the Phase 3 SORENTO study was completed during the quarter. A strong interest in the study resulted in rapid patient enrollment and the number of randomized study participants reached 332, exceeding the target of 302 patients. We are deeply grateful to the study participants and clinical investigators for their important contributions to SORENTO, which involves nearly 100 clinical centers in 12 countries in North America, Europe, Asia and Australia and is the largest randomized, controlled trial of its kind in GEP-NET.⁵

The study is designed to demonstrate statistically significant increased progression-free survival of patients with unresectable, metastatic GEP-NET in treatment with CAM2029 compared to current standard of care. The main results from SORENTO will be analyzed when 194 events of disease progression or death have been documented in the study. In addition to assessment of improved efficacy including tumor control and overall survival, other measures being evaluated include self-administration, treatment satisfaction and various quality of life measures.

Based on current information, interim results from SORENTO are expected towards the end of 2024 or in the first half of 2025.

PLD. Patient recruitment in the randomized, placebo-controlled Phase 2/3 POSITANO study, progressed during the quarter and was finalized after the end of the year after 71 patients had been enrolled. The study's primary outcome measure is reduced liver volume followed by patient-reported disease symptoms. Overall results are expected in the first half of 2025.

Preparations for the launch of Oclaiz™. The market potential for CAM2029 is estimated to exceed USD 2 billion across the three indications for which the drug candidate is being developed. During the quarter, the process continued to establish our own commercial organization in the US and prepare for a planned NDA approval of Oclaiz™ for the treatment of acromegaly in the US towards the end of 2024. Our activities have been focused on medical affairs, market access and designing the distribution model and been performed within the framework of our ongoing collaboration with our external US commercial advisors and consultants. In parallel, we have worked on the organizational development and getting Camurus Inc. fully operational and ready for then planned launch of Oclaiz™ in the US.

Broadening and deepening our pipeline and our sustainability work

During the year, we have invested more than SEK 600 million in research and development and have deepened and broadened our development pipeline. We also made significant progress in early programs focused on endocrinology, metabolism, and CNS, as well as with life cycle management activities for Buvidal. Based on these developments, we anticipate starting at least one new clinical program in 2024 targeting disease areas with significant unmet patient needs and market potential. Together with the anticipated CAM2029 catalysts and our improved finances, we continue expanding our opportunities to develop innovative medicines that can contribute to improved lives of patients with serious and chronic diseases. During the period Camurus signed an option to license agreement for a novel compound for potential application for the treatment of serious substance abuse and other CNS indications.

Furthermore, we continued to progress our sustainability work to reduce Camurus’ environmental footprint, further mitigate risks in our supply chains, and ensure a nice and safe working environment for our employees and partners. Notably, during the quarter, Camurus sustainability ratings by the independent research organization Sustainalytics were improved two levels to a risk level below the average of our peers in the pharmaceutical industry.

Positive ending to the year and outlook for 2024

Camurus finished 2023 with a strong and productive fourth quarter with revenues at the high end of our raised financial guidance from October. We significantly progressed the development pipeline, and the establishment of an own organization in the US ahead of an expected approval of Oclaiz™ in the US in Q4 2024. Our US operations will be headed by Behshad Sheldon, well known to us through her significant contributions as part of Camurus’ Board of Directors and experience from leading roles in the pharmaceutical industry during her time at BMS, Otsuka, Braeburn and most recently at Bio[1]tech Value Advisors. In these roles, Behshad has successfully led the commercialization of several market-transforming drugs with billion-dollar sales in the US and internationally. I am delighted that Behshad has accepted the role as President of Camurus Inc., based out of Princeton, New Jersey, and we look forward to a successful launch of our US business. Behshad will also join the Executive Management Team and will be leaving Camurus’ Board of Directors after the Annual General Meeting in May.

The financial outlook for the full year 2024 points to significant revenue growth of 33-42 percent, excluding one-time items in 2023. Investments in research and development are expected at a similar level as in 2023 while the investment in the US organization and preparing for launch of Oclaiz™ are anticipated to increase to about SEK 300 million in 2024. Despite investments of around SEK 900 million in development projects and the US establishment, Camurus is expected to deliver a strong result before tax of SEK 330 to 450 million in 2024.

In summary, we made excellent progress during the fourth quarter and remain on track for the vision for 2027 with further opportunities in the early pipeline and through business development. The continued success is the result of strong performance and contributions of highly engaged employees and partners, with support of shareholders, healthcare professionals, and not the least our patients, who make our work so meaningful.

Fredrik Tiberg
President and CEO

* Brixadi™ is the US brand name for Camurus’ product Buvidal®
**Oclaiz™ is the trade name for CAM2029 in acromegaly in the US