”Initial sales of Buvidal® follows plan and we are expecting to see significant growth during the year”
Summary first quarter 2019
- Buvidal® launched as the first long-acting medicine for opioid dependence in the EU; with initial sales in Finland, the UK, Sweden, Germany and Denmark
- Net revenues amounted to MSEK 18.5 (14.6), of which MSEK 11.0 (3.0) were from product sales
- Enrollment completed in the DEBUT clinical study, comparing Buvidal® with daily treatment with sublingual buprenorphine/naloxone
- Last patient last visit in the Phase 3 long-term extension study of CAM2038 for treatment of chronic pain
- Phase 3 study protocol for CAM2029 in acromegaly finalized after alignment with the US FDA
- Completed rights issue of MSEK 403
Significant event after the period
- Camurus’ partner Braeburn initiated court proceedings to overturn a market exclusivity extending to 30 November 2020 and seek immediate market approval of Brixadi™ (the US trade name for Buvidal®) for the treatment of opioid use disorder in the US
Outlook for 2019
- Net revenues are expected to be in the region of MSEK 130–160*, with product sales of MSEK 70–90
* Forecast does not include possible milestone payments relating to Brixadi™ in the US
Financial summary first quarter 2019
- Net Revenue MSEK 18.5 (14.6)
- whereof product sales MSEK 11.0 (3.0)
- Operating result MSEK -84.4 (-46.4)
- Result for the period MSEK -67.6 (-36.3)
- Earnings per share SEK -1.50 (-0.97), before and after dilution
- Cash position MSEK 406.6 (266.6)
During the first quarter of 2019, we initiated the European launch of Buvidal®, our in-house developed, weekly and monthly depots for the treatment of opioid dependence. In our first launch market, Finland, an estimated 6% of patients with opioid dependence are receiving Buvidal® after its first 3 months of availability. Subsequently, we have launched Buvidal® in the UK, Sweden, Germany and Denmark, with a considerable interest in all markets and a positive response from healthcare providers and patients.
Positive start of EU launch
Following the launch of Buvidal®, patients in the EU have access to the first innovative long-acting medication for the treatment of opioid dependence, with individualized flexible weekly and monthly dosing. So far, around 500 patients have initiated treatment with Buvidal®, including new-to-treatment patients, and patients transferring from daily medication with sublingual buprenorphine and methadone. The majority of these patients are from Finland and Germany, while initial patient uptake in the UK, Sweden and Denmark, has, as expected, been less rapid due to the reimbursement and formulary listing processes. In Norway and Australia, we have submitted pricing and reimbursement applications and are expecting positive decisions and aim to start launches shortly thereafter. Initial sales of Buvidal® follows plan and with the positive feedback and engagement with stakeholders we are expecting to see significant growth during the year.
Large interest in Buvidal® in the criminal justice setting
Aside from very positive signals from healthcare providers, we have also seen a significant interest in our long-acting treatment solutions for use in custodial settings, where the unmet medical need of a safe and effective treatment alternative is significant. Several prisons in Germany have recently begun using Buvidal® for the treatment of patients with opioid dependence, with the expectation that our long-acting treatments will lead to improvement of outcomes and significant treatment efficiencies. Additionally, treatment with weekly and monthly Buvidal® may facilitate the transition to outpatient treatment protecting patients from the known risks of overdose and death during the first weeks of being released from prison. To further the understanding of the contribution Buvidal® can make in custodial settings a clinical UNLOC-T study comparing Buvidal® with methadone at eight prisons in New South Wales, Australia, is also progressing and initial results are expected in the fourth quarter of 2019. With a large unmet need and more than 100,000 individuals with opioid dependence in the EU and Australian prison systems combined, we see significant opportunities for Buvidal® in the criminal justice setting.
In the first quarter of 2019 we completed enrollment in the DEBUT outpatient clinical study comparing Buvidal® with daily standard-of-care with sublingual buprenorphine/naloxone. Results are expected during the fourth quarter.
A detailed subgroup analysis of fentanyl users in the pivotal Phase 3 study of Buvidal® compared to sublingual buprenorphine/naloxone was also conducted. The results, showing improved outcomes and less illicit opioid use in patients treated with Buvidal®, were presented by Professor Edward Nunes, Columbia Medical School at the American Society of Addiction Medicine 50th Annual Meeting in Orlando, and generated significant interest.
Court proceedings initiated in the US
After the first quarter, our partner Braeburn filed an action in federal district court for the District of Columbia, seeking to overturn the market exclusivity extending to 30 November 2020 granted by the US Food and Drug Administration (FDA) to Sublocade™, and seeking immediate approval of Brixadi™. A court decision is expected during the third quarter of 2019.
Continued investment in the product pipeline
The last patients in the 52-week Phase 3 long-term safety extension study of CAM2038 in patients with chronic pain completed their treatment during the first quarter of 2019. After closing of the database and compiling of results and the study report, we will meet with European regulatory authorities to discuss the regulatory submission for CAM2038 for the treatment of chronic pain. We plan to submit in the EU during the first half of 2020.
Another important milestone for us is the start of the Phase 3 program for our subcutaneous octreotide, CAM2029, being developed for the treatment of acromegaly and neuroendocrine tumors (NET). CAM2029 has been designed for easy self-administration and optimization of treatment effects for these chronic diseases. During the first quarter, we initiated manufacturing and finalized the pivotal Phase 3 study protocol after alignment of study details with the FDA. Clinical trial applications are submitted in the US and a number of national regulatory authorities in Europe. The goal is to start treatment in the Phase 3 study of CAM2029 at the beginning of the third quarter of 2019.
We also continued to work on the development of a Phase 2 study of CAM2043 (treprostinil), for the treatment of pulmonary arterial hypertension (PAH) and systemic sclerosis and aim to initiate Phase 2 clinical trials in patients towards the end of the year. Additionally, activities continued in other internal projects as well as in our partnerships, including with Braeburn, Rhythm and Solasia.
To secure financing of prioritized development projects and for the launch of Buvidal® in Europe and Australia, we completed a rights issue of SEK 403 million before issue costs towards the end of the quarter.
Focus on launches and growth
Our key objective for 2019 is to give patients in Europe and Australia rapid access to treatment with Buvidal®. Based on the high unmet medical need in opioid dependence and the positive feedback on treatment with Buvidal® from both patients and healthcare providers, we expect to see significant sales and growth over the year. This ambition is supported by a strong commercial organization with fully operational regional teams in Germany, the UK, the Nordics and Australia, and with local presence in France, Spain and Italy. With the significant opportunity presented by Buvidal® in opioid dependence, alongside expected development milestones in our pipeline of innovative products and our partnerships, I believe the 2019 outlook for Camurus is optimistic and will enable us to deliver strong growth and value for patients and shareholders.
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, 1.00 PM CET on 9 May 2019.