Camurus had an excellent start to the year with strong sales growth, significantly increased result, and continued progress in our pivotal clinical programs. Product sales of Buvidal for the treatment of opioid dependence increased by 40 percent compared to last year, and we achieved approvals in new markets. In our pivotal Phase 3 study of CAM2029, the final doses were administered to patients with acromegaly, and topline results are expected late June.
Strong improvement of earnings in the first quarter
During the period, revenues increased to SEK 284 million, an increase of 29 percent compared to a strong first quarter of 2022 in which Camurus had significant one-off revenues including a milestone payment from our partner Rhythm and sales of clinical study materials. Operating result for the quarter increased to SEK 74 million compared to SEK 5 million in the first quarter of 2022, which is partly explained by lower costs for clinical studies in the first quarter of this year. Operating costs are expected to increase in the coming quarters as several milestones are expected to be reached in the ongoing Phase 3 studies.
This is the fourth consecutive quarter with profit; SEK 59 million, an increase of SEK 60 million compared to first quarter of 2022. The cash position at the end of the period was SEK 586 million,
and Camurus had no debt.
Net product sales of Buvidal were SEK 282 million, an increase of 40 percent compared to the first quarter of 2022, and 6 percent compared to the fourth quarter of 2022. The sales development shows the quality of our growth and the strong position of Buvidal in the market for the treatment of opioid dependence. Compared to the previous quarter, we had no significant one-off orders from e.g. the Middle East and Sweden. The number of patients in treatment with Buvidal at the end of this quarter is estimated to be above 39,000 based on in-market sales in March.
Australia and the Nordic countries continued to grow from a high baseline. In Norway, Finland, Denmark, Sweden and Germany, the number of patients on Buvidal continued to increase, and we saw an increased interest and use of Buvidal in criminal justice settings. New treatment guidelines for the prison service were issued in Sweden identifying Buvidal as first-line treatment for opioid dependence. In the UK, we exceeded 5 percent market share of treated patients and approaching 20 percent share of the buprenorphine segment. More than 80 percent of the clinics in England now have the possibility to prescribe Buvidal. In Spain, the last barriers to treatment were removed in key regions such as Andalusia and Catalonia, and we saw uptake of Buvidal.
The work to expand the market for Buvidal to new countries resulted in new market authorization approval in the United Arab Emirates (UAE) and price approval in UAE and Greece. To take advantage of the opportunities in Italy, a distribution agreement was signed with Molteni Farmaceutici, which has an established organization in place throughout Italy and significant resources in the therapy area for the treatment of opioid dependence. Initially, the launch will be outside national pricing approval and will be targeted to access regional funding.
We continue to be active in our scientific communication with four presentations about the improved outcomes with Buvidal given at four international conferences in Spain, France and Australia. In addition to other activities, Camurus supported a scientific symposium at the IMiA conference on 17-19 February in Melbourne, Australia and at the APSEP congress on 23-24 March in Toulon, France.
A decision on market authorization approval of
Brixadi™* in the US is expected shortly
In the US, we expect a decision from the US Food and Drug Administration (FDA) on Braeburn’s updated New Drug Application (NDA) for Brixadi for the treatment of opioid use disorder on or before 23 May, the target date for the approval decision (PDUFA date). We look positively at the prospect of an imminent approval of Brixadi in the US.
Braeburn has informed us that they are well prepared for an expected launch of Brixadi in the third quarter. Based on the high unmet medical need, together with several recent positive changes in the legislation for the treatment of opioid dependence in the US and the documented strong profile of Buvidal/ Brixadi, we have an optimistic view on the prospects for a successful launch of Brixadi in the US, if approved. We estimate that the market potential for Brixadi in a positive scenario exceeds USD 1 billion in annual sales.
Phase 3 study of CAM2029 in acromegaly under
completion and results expected end June 2023
Our pivotal clinical program for CAM2029 for the treatment of three rare, chronic diseases – acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD) – progressed well during the quarter.
In the acromegaly program, the focus was on completing the pivotal Phase 3 study, ACROINNOVA 1, to demonstrate treatment efficacy and safety of CAM2029. The study is progressing according to plan and the last treatment dose was administered in the Phase 3 study of CAM2029 in acromegaly. The last patient has now completed the study and transitioned to the long-term study, ACROINNNOVA 2. Our clinical team is working intensively to complete and close the first pivotal trial. We look forward to announcing topline study results towards the end of June. In parallel, preparations are ongoing for the readout of the first results from the Phase 3 long-term safety study, which are expected to be announced during the third quarter and to be included in the application for market approval (NDA), which we plan to submit to the FDA around year end 2023/24.
Alongside the work in our clinical studies, during the quarter we had a first meeting with our US advisory committee of leading clinical experts in acromegaly regarding the CAM2029 product profile and the ongoing clinical program. The response was positive, and we look forward to continued meetings and discussions ahead of the planned NDA submission and approval of CAM2029 for the treatment of acromegaly in 2024.
In the second Phase 3 program of CAM2029 for the treatment of patients with GEP-NET, recruitment of patients to the randomized, active-controlled Phase 3 study, SORENTO, progressed. The main objective of the study is to show significantly improved progression-free survival with CAM2029 compared to standard medical treatment. During the quarter, we reached approximately 50 percent randomized participants of the total target of 302 patients. Furthermore, we activated new clinical centers and added Australia to the list of countries where the study is being conducted. Our focus now is to recruit the remaining patients as quickly as possible in 2023 and then accumulate the 194 progression events required for read out of the primary endpoint. During the quarter, an investigator meeting was held in connection with the conference of the European Neuroendocrine Tumor Society held 22-24 March in Vienna, Austria. Interest in the study and CAM2029 was evident, both among study investigators and at the conference.
In the third CAM2029 clinical program targeting the treatment of PLD, for which there is currently no approved medical treatment, 25 percent of the randomization target of 69 patients was reached in the placebo-controlled Phase 2/3 study. The primary and first secondary endpoints of the study are stabilization and reduction of liver volume and reduction of disease symptoms. To expand the recruitment base, we increased the number of participating clinics during the quarter and added the UK with the aim of completing recruitment in the second half of 2023.
We see great opportunities for CAM2029 in these different treatment areas and anticipate significant commercial potential, with more than USD 2 billion in annual sales across the three indications.
In addition to clinical and regulatory activities, we are also preparing to establish our own tailormade, specialist commercial organization in the US and expand our existing infrastructure in Europe and Australia. We will build the commercial organization stepwise first focusing on the acromegaly launch.
Collaborations and organizational development
During the first quarter, progress was also made in other programs. Rhythm Pharmaceuticals completed the recruitment of patients in the Phase 3 study of our weekly formulation of setmelanotide, CAM4072, for the treatment of patients with genetic obesity disorders, primarily Bardet-Biedl’s syndrome. Topline PK results are expected in the second half of 2023. In parallel, preparations are ongoing for the start of a new clinical Phase 3 study in patients who have not previously received treatment with setmelanotide. The study is planned to start in the second half of 2023.
We also continued our efforts to strengthen Camurus as a company during the quarter. This included the recruitment of Alberto M. Pedroncelli as the new Chief Medical Officer (CMO) and member of Camurus’ executive management team. Alberto will be an important addition to our organization when he assumes his role on 1 June this year – he has extensive expertise in our future key clinical areas and is a recognized leader in acromegaly and GEP-NET. He replaces Peter Hjelmström who has left as CMO after seven productive years with the company. We would like to thank Peter for all his great work over this time.
In the area of sustainability, Iris Rehnström joined Camurus as our Director Sustainability on 1 February this year. She has already made an impression on the business, for example by contributing to improving our sustainability reporting and initiating a full mapping of our value chain. During the quarter, we presented our sustainability report as part of Camurus’ Annual Report 2022. See the report and read more about our sustainability work at camurus.com/sustainability.
Strong quarterly development and outlook for continued value creation
Camurus has delivered another strong quarter with solid organic growth, both top and bottom line, in parallel with continued investments in our clinical development programs. Buvidal continues to grow, resulting in more and more patients gaining access to an effective and often life-changing long-term treatment alternative for opioid dependence.
During the quarter, we also made important progress in our clinical programs. Next in line are topline results from our randomized, double-blind, placebo-controlled Phase 3 study of CAM2029 in patients with acromegaly in June, followed by a significant news flow during the second half of 2023.
Overall, we had an excellent first quarter with good progress towards our full year targets and long-term vision for Camurus.
President and CEO
* Brixadi™ is the US brand name for Camurus’ product Buvidal®