”The approval of Buvidal is a major milestone for Camurus and an important validation of our innovative FluidCrystal® technology.”
Business highlights fourth quarter 2018
- Buvidal approved by the European Commission as the first long-acting treatment for opioid dependence in the EU
- Buvidal Weekly and Buvidal Monthly approved in Australia as the first long-acting treatment of opioid dependence
- US FDA issues a tentative approval of Brixadi for treatment of opioid use disorder
- Camurus Capital Markets and R&D Day held at IVA conference center in Stockholm
- Publications of positive: CAM2029 Phase 2 results in acromegaly and neuroendocrine tumor patients in Cancer Chemotherapy and Pharmacology; episil® Phase 3 results in Onco Targets and Therapy
- Clinical results for CAM2038 presented at International Society for Addiction Medicine (ISAM) in Busan Korea; Society for the Study of Addiction (SSA) in Newcastle UK; American Academy of Addiction Society (AAAP) in Bonita Springs, Florida; Australasian Professional Society on Alcohol and other Drugs (APSAD) in Auckland New Zealand
Financial summary fourth quarter 2018
- Net Revenue MSEK 7.8 (5.5).
- Operating result MSEK -103.2 (-66.1).
- Result for the period MSEK -87.1 (-55.2).
- Earnings per share SEK -2.27 (-1.40), before and after dilution.
- Cash position MSEK 134.4 (314.5).
Financial summary full year 2018
- Net Revenue MSEK 49.3 (54.3).
- Operating result MSEK -287.2 (-243.5).
- Result for the period MSEK -234.7 (-190.6).
- Earnings per share SEK -6.20 (-5.11), before and after dilution.
- Cash position MSEK 134.4 (314.5).
2018 was a breakthrough year for Camurus. Buvidal was approved as the first long-acting depot treatment of opioid dependence in the EU and Australia. With distribution, marketing and sales in place, the European launch was quickly initiated with the first patients receiving treatment already by mid-January 2019. Physician and patient feedback has been positive, which is encouraging as we continue the roll-out of Buvidal on new markets. Also gratifying during the year was the positive Phase 3 results for CAM2038 in chronic pain.
In November 2018, we announced that the European commission and Therapeutic Goods Administration had approved Buvidal as the first long-acting injection treatment for opioid dependence in the EU and Australia.
To bring an innovative drug candidate from idea to approved medicine is a challenging process and the approvals are monumental milestones in our company’s history. We are proud to be able to give patients with opioid dependence access to a much-needed new treatment paradigm with a demonstrated potential to improve treatment outcomes and quality of life of patients by reducing the significant burdens and risks associated with current daily medications.
The approval of Buvidal is a major milestone for Camurus and an important validation of our innovative FluidCrystal® technology.
Science-led commercial-stage pharmaceutical company
During 2018, we have continued the transformation of Camurus from an R&D focused company to an integrated, science-led commercial company. We grew our organization and are now one hundred employees and twenty fulltime consultants working from our Lund headquarter and regional offices in Cambridge, Mannheim, Paris and Sydney. Half of our people are in the commercial organization working with market access, medical education, marketing and sales and receiving cross-functional support from our strong teams in R&D, manufacturing and supplies, HR and finance. Together we are working passionately to make Buvidal available to patients around the world.
Of the estimated 1.5 million high-risk heroin and opioid users in Europe and Australia, less than half receive opioid dependence treatment today. Based on our current estimates, approximately 740,000 persons with opioid dependence could benefit from treatment of opioid dependence with long-acting medications and at least 100,000 patients could be in treatment with Buvidal in five years.
By providing weekly and monthly dosing options, Buvidal can improve adherence, without the requirement of frequent, often daily, visits to treatment clinics which can be burdensome and socially stigmatizing.
Buvidal launched in Finland, Sweden and the UK
In January 2019, Buvidal was launched in Finland, Sweden and the UK. The initial feedback from treating physicians and patients has been very positive, which is encouraging as we continue to roll-out Buvidal in Europe and Australia.
Alongside our commercial activities, we are expanding the comprehensive clinical evidence-base for Buvidal. During the period, recruitment of patients was started in a clinical study in the custodial setting. The study, sponsored by the Government of New South Wales, is conducted in seven prisons and evaluates the treatment with Buvidal versus methadone. We also have a study of Buvidal versus sublingual buprenorphine in the outpatient setting ongoing with focus on patient satisfaction and quality of life outcomes. Both studies are recruiting well and expected to deliver topline results late 2019.
After announcing positive Phase 3 efficacy results in chronic pain during the third quarter, the clinical development of Buvidal (CAM2038) in this indication continued with the long-term safety extension study. Results are expected in the second quarter 2019 and will be followed by discussions with health authorities before submission of market authorization applications.
Tentative US approval of Brixadi™
In the US, our partner Braeburn received a tentative approval of Brixadi (the US trade name for Buvidal), signifying that all regulatory requirements for approval were fulfilled. However, final approval of the monthly product was blocked by a market exclusivity granted extending to November 2020. The unexpected broad scope of the market exclusivity was decided by the FDA at the time of the tentative approval of Brixadi. Given the magnitude of the opioid crisis in the US, it is imperative that Brixadi is available as soon as possible to allow patients access to a new treatment which fulfils critical unmet medical needs. Several paths to address the current situation and being pursued by Braeburn.
Fully underwritten rights issue
From a financial perspective, the tentative approval meant that the USD 35 million milestone payment expected from Braeburn after market approval of Brixadi in 2018 is delayed. In view of this, our Board of Directors has resolved to, subject to Extraordinary General Meeting approval, carry out a new share issue with preferential rights for the company’s shareholders to raise gross proceeds of approximately SEK 400 million.
The proceeds from the rights issue will be used to finance the launch and marketing of Buvidal in Europe and Australia, progress the clinical development of key pipeline programs, including Phase 3 studies of CAM2029 in acromegaly and neuroendocrine tumors, and other prioritized programs, such as a Phase 2 study of CAM2043 for treatment of pulmonary hypertension.
The rights issue is fully committed and underwritten by current shareholders and external guarantors. We are of course thankful to all our shareholders for their support and commitment.
We look forward to a productive 2019 as we continue to launch Buvidal in key markets and progress the development of our innovative therapies.
President and CEO
For more information:
Fredrik Tiberg, CEO and Head of Research
Tel. +46 (0)46 286 46 92
Fredrik Joabsson, Chief Business Development Officer
Tel. +46 (0)70 776 17 37
This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Swedish Securities Markets Act. The information was submitted for publication, through the agency of the chief executive officer, 07.00 AM CET on 6 February 2019.