Camurus had a successful second quarter with increased growth for Buvidal® in Europe and Australia and positive development for Brixadi® in the US. The evidence base for these treatments was expanded with several new publications, including data on treatment efficacy in opioid dependent patients using fentanyl. Our product portfolio continued to advance with two regulatory applications under review for CAM2029 for the treatment of acromegaly, with expected approval decision by the FDA in October 2024 and by the EMA around the middle of next year. In parallel, pre-launch activities for Oclaiz™ and the establishment of our commercial organization in the US progressed according to plan. After the period, positive topline results from ACROINNOVA 2 were announced, confirming the safety profile and long-term efficacy of CAM2029 for the treatment of acromegaly.

Solid operational performance and fiancial results

Camurus’ operations and revenues developed well during the quarter, resulting in organic growth of 46 percent (41 percent at CER) compared to the previous year, excluding a one-time milestone of SEK 369 million on FDA approval of Brixadi in the US in 2023. Total revenues during the period were SEK 445 million, mainly attributable to sales of Buvidal in Europe, the Middle East and Australia, and royalties from the sales of Brixadi in the US. Operating expenses during the period were SEK 331 million, of which SEK 174 million represented R&D investments in our advancing pipeline. Profit before tax was SEK 104 million.

Excluding the one-time milestone, total revenues in the first half of the year increased by 42 percent to SEK 835 million and profit before tax by 129 percent to SEK 201 million. Based on the robust operational performance, we expect to finalize in the mid to high range of provided full year 2024 guidance. Cash flow during the period was SEK 293 million resulting in a cash position at the end of the period of SEK 2,6 billion.

Strong sales growth for Buvidal and Brixadi

The positive long-term growth trajectory for Buvidal continued during the quarter as we addressed barriers to reimbursement and funding, which has increased access to evidence-based treatment for patients with opioid dependence. Sales of Buvidal during the quarter were SEK 400 (305) million, a 31 percent increase versus same period last year (28 percent at CER), and 10 percent (6 percent at CER) versus previous quarter. The market development and response from patients and healthcare providers in Europe and Australia continues to be very positive.

In Germany, sales increased significantly as a result of strong execution by our German team and implementation of new market initiatives. In England and France, as well as other markets, an increasing interest in Buvidal is noted among key stakeholders within the healthcare system and new funding has become available at clinics. Inventory levels in the UK and Australia have normalized compared to the first quarter, resulting in reported results better reflecting in-market sales. In Australia, the market share of long-acting injectable buprenorphine is estimated to exceed 30 percent of the total number of patients in treatment for opioid dependence and Buvidal has about 80 percent share of this segment. Growth in Finland continues from an already very strong position for Buvidal with a high double-digit market share. In total, more than 53,000 patients were estimated to be in treatment with Buvidal at the end of the period, a net increase of more than 3,000 patients.

In the US, the market uptake for Brixadi* continued to impress. Compared to the previous quarter, sales increased by about 75 percent, resulting in royalty revenue from our license partner Braeburn of SEK 45 million compared to SEK 26 million previous quarter. Coverage rates among US payers (Medicaid, commercial, correctional, and federal) continued to increase from an already high level and the distribution chain was strengthened to increase access to Brixadi for patients in need in the US.

The adoption rate of Brixadi, alongside a significant unmet medical need and high interest from treatment providers and patients, strengthens our positive view on the market potential of Brixadi in the US.

Expanded scientific evidence base for Buvidal and Brixadi

During the period, more than 15 scientific articles were published on Buvidal (Brixadi) expanding the evidence base in the treatment of opioid dependence. This included new data from a post hoc analysis of our previous Phase 3 study, supporting the use of Buvidal/Brixadi in opioid dependent patients using fentanyl, published in JAMA Network Open¹. Furthermore, we had significant presence at leading international conferences, including ASAM in Dallas, CPDD in Montreal, ALBATROS in Paris and EUROPAD in Lisbon, where important new findings and results regarding the use of Buvidal and Brixadi were presented. Additionally, 12 investigator-initiated studies with Buvidal and Brixadi in various clinical applications progressed.

Registration applications for CAM2029 under review in the EU and US

During the quarter, we continued to advance our three CAM2029 development programs for the treatment of acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD):

In the acromegaly program, our Marketing Authorization Application (MAA) for CAM2029 for the treatment of acromegaly was accepted for review by the European Medicines Agency (EMA). A decision on market approval in the EU is expected around mid-2025. In parallel, the review process of our New Drug Application (NDA) for CAM2029 (Oclaiz™**) by the US Food and Drug Administration continued to advance towards the PDUFA action date 21 October 2024.

In addition to the regulatory progress, we participated at all leading endocrinology conferences. Several presentations and posters with topline results from ACROINNOVA 1 and interim results from ACROINNOVA 2 were presented at AACE in New Orleans, ENDO 2024 in Boston and ECE 2024 in Stockholm, where we also had a well-received satellite symposium on new and upcoming treatments for acromegaly.

After the end of the quarter, we reported positive final topline results from the 52-week Phase 3 ACROINNOVA 2 study, confirming previously communicated interim results.² The study included a total of 135 patients with acromegaly of which 81 were new recruited patients, the majority of whom were not biochemically controlled on standard of care (SoC) at baseline (IGF-1<2xULN). The remaining 54 patients were transferred to ACROINNOVA 2 after six months of treatment with CAM2029 or placebo in ACROINNOVA 1 and were generally controlled on SoC at baseline (IGF-1≤1xULN). The results from ACROINNOVA 2 showed that CAM2029 is well tolerated with a safety profile consistent with SoC with first-generation somatostatin receptor ligands (SRL). There was a significant improvement in treatment response from SoC at baseline to the end of the study of 12.7 percent (95%CI: 11.6, 33.9).  For new recruited patients the increase was 22.8 percent (95%CI:11.6, 33.9), while controlled patients on SoC remained controlled after treatment with CAM2029. In addition, reduced disease symptoms and improved treatment satisfaction and quality of life were reported after treatment with CAM2029 compared to SoC at baseline. If approved, CAM2029 has the potential to become an important new treatment option for patients living with acromegaly.

In the GEP-NET program, the Phase 3 SORENTO study progressed. The goal is to demonstrate increased progression-free survival when treated with CAM2029 compared to current SoC for GEP-NET with first generation somatostatin receptor ligands^3,4. The primary endpoint of the study will be read out after 194 events of tumor progressions or deaths have been observed. Based on available information, topline results are expected in the first half of 2025.

Finally, our Phase 2/3, randomized, placebo-controlled study POSITANO, which is evaluating treatment efficacy and safety of CAM2029 in patients with symptomatic PLD, progressed according to plan. Topline results from the study are expected in the first half of 2025.

Preparations for a clinical study of a semaglutide monthly depot

During the quarter, an additional preclinical study of a FluidCrystal® monthly depot of the GLP-1 receptor agonist semaglutide (CAM2056) was completed. Data from the study show that repeated escalated dosing of CAM2056 was well tolerated, resulting in continued significant dose-dependent weight reduction compared to placebo. Based on the results, Camurus is preparing for a clinical study to evaluate the pharmacokinetics, pharmacodynamics and safety of repeated dosing of CAM2056. The study is planned to start around the turn of the year 2024/25. In parallel, preclinical evaluations of other product candidates, including GLP-1 analogues, continued with promising initial results.

Sustainability and organizational development

During the quarter, we completed and submitted our first Communication on Progress to the United Nations Global Compact,⁵ and participated in the accelerator programs Human Rights and Climate Ambition. Furthermore, we renewed our certificate as a Nasdaq Transparency Partner, strengthened our compliance framework, and supported and participated in activities to decrease stigma and improve patients’ access to treatment.

Sustainability was also on the agenda at our internal global meeting held in May. In addition to reviewing and planning sustainability work across business areas, the meeting was a great opportunity for all of us, including the new team in the US, to meet and celebrate our achievements, discuss the implementation of company goals and strategy, and share and develop our corporate culture and values.

The establishment of our US organization continues under the leadership of Behshad Sheldon. In the second quarter, key functions were onboarded with enthusiastic and dedicated new employees with extensive experience of successful product launches and commercialization of specialty and rare disease medicines in the US market. The recruitment of regional sales managers and pharmaceutical representatives was also initiated with the goal of having a full team in place during the fourth quarter of 2024, ready for the launch of Oclaiz™. During the quarter we appointed Bo Tarras-Wahlberg as VP Legal & Group General Counsel and member of the company’s executive management team, starting early fall 2024. Bo has extensive international experience from senior legal roles in the pharamceutical industry. He joins Camurus from a position as Associate General Counsel, Western Europe Infusion Therapies & Technologies and Pharma at Baxter Healthcare.

Strong performance in the first half of the year bodes well for 2024

Camurus delivered high sales growth and profitability in the second quarter while also making significant investments in our pipeline and our US operations. Sales of Buvidal and Brixadi were strong and the scientific evidence base continued to expand. At the same time, we are approaching the PDUFA action date for a potential FDA approval of CAM2029 and preparing for a commercial launch of Oclaiz™ in the US. New Phase 3 data show that CAM2029, if approved, could become an important new treatment option for patients with acromegaly. Assuming positive results from the ongoing SORENTO study, CAM2029 also has potential as a new first-line treatment for patients with GEP-NET.

Based on our strong financial position and continued profitability, Camurus is well prepared for bringing CAM2029 to patients across our markets and target indications. At the same time, we continue expanding and progressing our early pipeline of preclinical and clinical programs.

Furthermore, we are active in business development, including the evaluation of products and product candidates with commercial or pipeline synergies.

Camurus’ commitment to make new innovative medicines available to patients with serious and chronic diseases continues. We have an exciting period ahead of us with continued focus on commercial growth and advancement of our pipeline, and we look forward to reaching new significant milestones over the coming quarters.

Lastly, thank you all coworkers and collaborators for your contributions to Camurus’ progress this quarter.

Fredrik Tiberg

President and CEO

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