Camurus had a productive first quarter with increased revenues, improved results, and progress in our development portfolio. Sales of Brixadi® in the US grew strongly and royalty revenues from Braeburn tripled compared to the previous quarter. The New Drug Application (NDA) for Oclaiz™ (CAM2029) for acromegaly was accepted for review by the US FDA with a target approval (PDUFA) date of 21 October this year. Furthermore, we completed recruitment in the POSITANO study of CAM2029 in patients with polycystic liver disease. In the early project portfolio, promising results were obtained for a new monthly depot of semaglutide heading into clinical development.

Strong financial performance

Compared to the corresponding period last year, total revenues in the first quarter increased by 37 percent to SEK 390 (284) million, in the midpoint of market guidance, driven by sales of Buvidal® and growing royalty revenues from Brixadi in the US. Operating expenses increased by 57 percent to SEK 289 (184) million, of which SEK 180 (99) million represented investments in research and development (R&D). Despite the increased R&D costs of just over SEK 80 million, profit before tax during the period increased to SEK 97 (77) million.

Cash position at the end of the first quarter was SEK 2.3 (0.6) billion, an increase of SEK 1.7 billion compared to the same quarter in 2023, including proceeds from a directed share issue of just over SEK 1 billion successfully performed in January. Cash flow from operating activities amounted to SEK 139 million. Hence, we have further strengthened Camurus’ financial position and ability  to successfully deliver on our long-term strategy and bring new innovative medicines to market, expand operations in the US, and acquire or license complementary products and product candidates.

Towards a globally leading position in the treatment of opioid dependence

Through the development of Buvidal and Brixadi weekly and monthly buprenorphine depots, Camurus has established a strong position in the treatment of opioid dependence with sales on four continents. Buvidal product sales during the first quarter amounted to SEK 364 (282) million, corresponding to an increase of 29 percent compared to the same quarter in 2023 (30 percent at CER).

After a strong finish to 2023, a soft start was noted in January and February followed by a recovery in March. This was mainly due to seasonal variation in inventory levels in Australia, the UK, and Germany, delays in the availability of funding for healthcare providers in the UK and negative currency effects. In countries such as Sweden and Finland, growth remained stable. At constant exchange rates, sales of Buvidal increased by 3 percent compared to the fourth quarter, while in-market sales grew by about 5 percent. At the end of the quarter, more than 50,000 patients were estimated to be in treatment with Buvidal. Our efforts to increase access to treatment for patients with opioid dependence continued, resulting in a new price and reimbursement approval for Buvidal in Ireland, widening access to all key treatment clinics.

In the US, sales of Brixadi* accelerated during the quarter. Royalty revenues from our licensee Braeburn increased from SEK 8 to 26 million, corresponding to a substantial increase in net sales compared to the previous quarter. Based on prescribing data, more than 7,000¹ patients were estimated to be on treatment with Brixadi six months after launch, and an already strong payor support has continued to improve in the quarter. The excellent market performance reflects the strong launch execution by Braeburn, competitive profile of Brixadi, and a high unmet medical need exacerbated by the ongoing US opioid and fentanyl crisis. In this regard, we look forward to upcoming data on the use of Brixadi/Buvidal in opioid use disorder patients who used fentanyl.

In addition to commercial successes, investigator-initiated clinical studies of Buvidal and Brixadi are ongoing in various treatment settings and patient populations around the world. Results from several of the studies are expected throughout the coming year and will contribute to the growing evidence base for this treatment. Several new scientific publications on Buvidal and Brixadi were published during the quarter^2-8 and additional key publications are expected near-term.

We look forward to Buvidal/Brixadi being established as the leading long-acting treatment for opioid dependence, globally, already this year.

NDA application for Oclaiz™ accepted for FDA review

During the first quarter, important progress was made in our ongoing development programs for CAM2029, octreotide subcutaneous depot, for the treatment of acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD):

In the acromegaly program, the FDA announced that the NDA application for Oclaiz™** had been accepted for review with PDUFA date 21 October this year. The review is underway and we look forward to working closely with the Agency during the continued process. In parallel, we have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) after discussing and aligning with EMA representatives on key submission topics.

On the clinical side, the last patient received treatment in the main part of ACROINNOVA 2, and remaining patients are now in the extension period. Having previously announced positive interim results from ACROINNOVA 2, we look forward to updated results for the complete study population towards the end of the second quarter of this year.

Several abstracts with key results from the ACROINNOVA 1 & 2 studies have been accepted for presentation (oral or poster) at the leading endocrinology conferences during the spring, including AACE in New Orleans, ECE in Stockholm and ENDO in Boston. Camurus will also be present at these meetings with our medical affairs and commercial teams and at ECE we are also organizing a satellite symposium.

In the GEP-NET program, treatment of patients progressed in our pivotal Phase 3 study, SORENTO. In the study, 332 patients with unresectable metastatic GEP-NET are randomized to treatment with CAM2029 or current standard treatment with lanreotide ATG or octreotide LAR. The primary endpoint is increased progression-free survival in patients treated with CAM2029 compared to those receiving current standard treatment. The main results from SORENTO will be assessed after 194 events of disease progression or death and topline results are currently estimated to come in the first half of 2025.

In the PLD program, patient recruitment was completed in the randomized, placebo-controlled Phase 2/3 study, POSITANO, of CAM2029 in patients with PLD. The study’s primary outcome measures are decreased liver volume and patient-reported disease symptoms. Overall results are expected in the first half of 2025.

Promising results in the early development portfolio

We advanced several early projects during the quarter. One such program is a monthly FluidCrystal® formulation of the glucagonlike peptide-1 (GLP-1) receptor agonist semaglutide, which is developed and marketed by Novo Nordisk for the treatment of patients with type 2 diabetes and obesity. Semaglutide is available as a solution for weekly dosing or daily oral administration. A subcutaneous formulation for monthly administration could potentially improve convenience and treatment compliance, simplify titration, and enhance the treatment experience of patients.

During the quarter we received positive data from preclinical assessments of monthly FluidCrystal semaglutide formulations, which met the target product profile for pharmacokinetics and tolerability. The next steps include the preparation and initiation of a clinical study to evaluate pharmacokinetics, pharmacodynamics and safety of FluidCrystal semaglutide in an escalated, single and repeated dose Phase 1 study in healthy study participants. In parallel, we have progressed additional product candidates, including GLP-1 analogues, with positive initial results that warrant further development and evaluation, including potentially clinical investigations.

Organizational development and sustainability

At the start of the quarter, Camurus was moved to the Large Cap segment on Nasdaq Stockholm – a confirmation of our performance since our listing in 2015. In this context, we would like to take the opportunity to thank outgoing Board members Kerstin Valinder Strinnholm, Ole Vahlgren and Behshad Sheldon for their significant contributions during their years as members of Camurus’ Board of Directors. Behshad Sheldon has now assumed the role as President of Camurus Inc. with responsibility for the US organization and preparations for the planned launch of Oclaiz™. Several key positions in Camurus Inc. have now been onboarded and during the period we have signed for our US office, located at the Carnegie Center, Princeton, NJ.

In the area of sustainability, our Sustainability Report 2023 was published at the end of March. The report is partially aligned with the new Corporate Sustainability Reporting Directive (CSRD), which Camurus is to fully comply with starting 2025. We have also updated our materiality analysis, conducted a climate-scenario analysis, and presented our long-term goals and action plan for renewable energy and transition to climate neutrality by 2045. Furthermore, we conducted a project aimed at improving access to innovative medical treatments for individuals in particularly vulnerable groups, such as women with opioid dependence.

Positive start to a year with large opportunities

Camurus had a promising start to 2024 with increased profitability, strong operational performance and continued progress in our development programs. The financial outlook for the full year 2024 is reiterated with revenues of SEK 1,740 – 1,860 million and a profit before tax of SEK 330 – 450 million.

We look ahead to another successful year for Camurus as we grow our revenues, strengthen our commercial platform, prepare for launch of Oclaiz™ in the US, develop new partnerships, and continue advancing our innovative therapeutic candidates for the benefit of patients with severe and chronic disease conditions.

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