ABOUT CAMURUS

Delivering better treatments


Camurus is committed to developing and commercializing innovative and long-acting medicines for the treatment of severe and chronic conditions, including opioid dependence, pain, cancer and endocrine disorders. New drug products are based on our proprietary FluidCrystal® drug delivery technologies with the purpose to deliver improved quality of life, treatment outcomes and resource utilization. The company’s share is listed on Nasdaq Stockholm under the ticker “CAMX”.

 

ABOUT CAMURUS

Delivering better treatments


Camurus is committed to developing and commercializing innovative and long-acting medicines for the treatment of severe and chronic conditions, including opioid dependence, pain, cancer and endocrine disorders. New drug products are based on our proprietary FluidCrystal® drug delivery technologies with the purpose to deliver improved quality of life, treatment outcomes and resource utilization. The company’s share is listed on Nasdaq Stockholm under the ticker “CAMX”.

CEO STATEMENT THIRD QUARTER 2020

Continued strong growth and business progress


CEO STATEMENT

Phase 3 long-term study confirms safety and continuous treatment efficacy



During the third quarter, we continued to make excellent progress with Buvidal® for the treatment of opioid dependence despite the challenge of Covid-19. Product sales in the quarter grew by 383%, net revenue by 150%, and operating costs were unchanged compared to the third quarter of 2019. New, compelling real-world evidence in support of treatment with Buvidal was presented in scientific publications, at conferences and featured in international media. After a temporary stall due to Covid-19, recruitment to our Phase 3 studies of CAM2029 for the treatment of acromegaly was reinitiated. We held an advisory meeting with the US FDA aligning the design for the pivotal Phase 3 study of CAM2029 in neuroendocrine tumors (NET). In addition, we completed the development of an autoinjector for CAM2029 for use in clinical studies and received approvals for the start of two new clinical trials.


Buvidal growth journey continues
Product sales in the third quarter amounted to SEK 94.3 million, an increase of 383% compared to the third quarter 2019 and 24% (26% at CER) compared to the previous quarter. Good performances were seen across markets and we are on track to deliver on our revenue guidance from June this year, despite a slowing down of new patient initiations during the summer months in Europe. Also, we had some challenges resulting from the Covid-19 pandemic; particularly with Austrian prescription authorizations, lock downs in parts of Australia, and delays of pricing processes in new launch markets. However, we started to regain growth momentum after the summer and we now look forward to new launches of Buvidal during the coming months.

In our largest markets – Australia, Finland and Norway – we continued to capture market share with Buvidal during the quarter. Also, we saw significant growth in other markets, including the UK, Germany and Sweden as funding and infrastructure hurdles have been addressed. Including Austria, Belgium and the Middle East, where treatment is provided through early access programs, Buvidal is now accessible in 11 countries with an estimated 12,000 patients in treatment. As part of our lifecycle management strategy, we have submitted applications for label enhancements in the EU and Australia and in addition we are awaiting market authorization approval decisions in Switzerland and New Zealand.

Positive real-world experience of Buvidal
Alongside the expanding use of Buvidal, the scientific evidence-base has continued to grow. The medical need for long-acting opioid dependence treatments has been high-lighted by the Covid-19 epidemic, as underscored by recent scientific publications1,2 about the usefulness of Buvidal in outpatient and prison treatment settings. Buvidal was also prominently featured at the Improving Outcomes in Opioid Dependence (IOTOD) conference held virtually in late September. Four oral talks and seven scientific posters featured results from clinical studies of Buvidal, including compelling real-world experience how Buvidal has positively impacted on treatment outcomes and the lives of patients with opioid dependence.

Developments in the US
In the US, we have supported our partner Braeburn with data and information for the expected final approval of weekly and monthly Brixadi™ (the US trade name for Buvidal), which is expected on 1 December 2020. Based on the positive real-world experience of Buvidal in Europe and Australia, we believe Brixadi has the potential to become an important new treatment option that could contribute to lessening the detrimental impacts of the ongoing opioid crisis in the US. Brixadi is uniquely positioned to address the medical needs of patients, while also effectively addressing issues of diversion and misuse associated with current daily medications. In parallel with the FDA review of Brixadi, Braeburn initiated arbitration proceedings in England to seek a deter-mination by the arbitral tribunal of whether the company is in material breach of the license agreement with Camurus3. During the expedited process, the parties’ respective rights and obligations under the license agreement remain in full force and effect, including Braeburn’s obligation to develop, register and commercialize Brixadi™, as well as associated financial terms. Camurus will report on the outcome of the process as soon as the tribunal’s award has been received.

Progress of pivotal clinical studies of CAM2029
During the third quarter, additional clinical sites have been established and recruitment is progressing in both the pivotal Phase 3 efficacy and the open-label long-term safety studies of long-acting octreotide (CAM2029) for the treatment of acromegaly. This following a temporary recruitment stall during the second quarter due to Covid-19. We are expecting to complete the efficacy study in 2021 followed by the long-term safety study in the first half of 2022.
In parallel, we are preparing the start of the Phase 3 program of CAM2029 for the treatment of neuroendocrine tumors (NET), which was discussed and aligned with the US FDA in an advisory meeting in August. Additionally, we completed the customization of the CAM2029 autoinjector for the start of a bridging clinical study of pharmacokinetics and pharmacodynamics. Finally, we moved forward with our plans to start clinical development in new indications, including polycystic liver disease (PLD), where the study program is being designed in collaboration with leading experts in the US and Europe.

Early pipeline and R&D developments
Preparations for a Phase 2 study of our weekly treprostinil injection, CAM2043, for the treatment of Reynaud’s phenomenon, were completed in the third quarter. The study will begin before year-end, unless our plans are further impacted by Covid-19.
Following the announcement of positive Phase 2 results for weekly setmelanotide for the treatment of rare obesity disorders, our partner Rhythm is preparing discussions with the US FDA about the registration path for this product.
In addition to these projects, we had interesting break-throughs in our early development pipeline during the quarter and we are looking forward to announce the start of at least one new clinical program in 2021. To strengthen our medical function and further accelerate our clinical development programs, we appointed Peter Hjelmström as Chief Medical Officer and member of Camurus’ Management team. Peter holds degrees as medical doctor, PhD and lecturer from Karolinska Institute and has extensive industrial experience from positions at Biovitrum (now Sobi), Orexo and Alexion.

Strong third quarter results
In the third quarter, we continued to deliver strong growth, result and business development. Operating expenses remained stable and we completed a directed share issue of SEK 300 million, allowing us to exit the quarter with a healthy cash position. Full year operating expenses, disregarding the potential outcomes of the ongoing arbitration process, are expected to be lower than previous guidance, mainly due to adjustments of clinical study timelines, including manufacturing, and reduced costs for travel, congresses and marketing following the Covid-19 pandemic.
In summary, we have had a productive third quarter with positive financial development and significant progress in the pipeline. We now look forward to a strong finish of the year and that Brixadi finally will become available to US patients after an expected FDA approval on 1 December 2020.

Fredrik Tiberg
President and CEO

References
1. Straub A et al. The development and implementation of a rapid-access long-acting injectable buprenorphine clinic in metropolitan Melbourne during the COVID-19 pandemic. Drug Alcohol Rev. 2020; Online ahead of print.
2. Roberts J et al. Rapid upscale of depot buprenorphine (CAM2038) in custodial settings during the early COVID-19 pandemic in New South Wales, Australia. Addiction. 2020; Online ahead of print
3. Camurus press release 15 June, 2020, Braeburn and Camurus enter arbitration proceedings in England

We had a busy and productive first quarter with five ongoing clinical trials and several studies under initiation. The last patients completed treatment in the Phase 3 long-term safety study of CAM2038, weekly and monthly buprenorphine depots. New top-line Phase 3 results support the long-term safety and efficacy of CAM2038 in patients with opioid dependence. Having concluded pre-submission meetings with EMA and FDA, market approval applications for CAM2038 are now being finalized.


During the first quarter, we completed treatment of all patients in the open-label, long-term safety Phase 3 study of our weekly and monthly depots of buprenorphine together with our US partner Braeburn Pharmaceuticals. 228 patients in Europe, the U.S. and Australia were randomized in the study. Topline results demonstrated that the CAM2038 weekly and monthly depots were well tolerated and provided continuous treatment effect across the 48-week treatment period. Study retention was high, with 71% of patients completing the 48-week study treatment period.

After positive pre-submission meetings with the regulatory authorities (EMA and FDA), we are together with Braeburn Pharmaceuticals finalizing our market marketing authorization application and new drug applications (MAA and NDA) for submissions in mid-2017. The preparations for our anticipated 2018 launch of CAM2038 in Europe is well on-track, with the aim to provide patients rapid access to a new treatment alternative with the potential to improve both treatment outcomes and quality of life.

We are also working to expand the future indications for CAM2038 to treatment of chronic pain and expect to complete the ongoing pivotal Phase 3-study in patients with chronic low-back pain before the end of the year. During the period, a meeting was held with FDA regarding the product registration for chronic pain. There is a significant unmet medical need for new therapeutic options for treating chronic pain, highlighted by the current opioid crisis and issues of diversion, misuse, dependence and overdoses relating to the use of prescription opioids. CAM2038 may effectively address these problems and become an important treatment alternative, including for patients in need for higher doses of opioid analgesics and risks of dependence, and may also provide effective and long-acting pain relief.

In our collaboration with Novartis for our long-acting octreotide depot, CAM2029, for treatment of acromegaly and neuroendocrine tumours, GMP-manufacturing was performed during the period for Novartis’ planned start of Phase 3 studies later this year. Results from our previous Phase 2 study of CAM2029 in acromegaly and NET patients were presented at two scientific conferences; ENETS 2017 in Barcelona and ENDO 2017 in Orlando.

In the early clinical pipeline, treatment of the last cohorts is ongoing in the Phase 1 study of CAM2047 for treatment of chemotherapy-induced nausea and vomiting (CINV), and CAM2048 and CAM2058 for treatment of pain, nausea and vomiting. Study results are expected third quarter 2017. We are also preparing the start of the first clinical trial of our subcutaneous treprostinil depot, CAM2043, aiming at the development of a new treatment alternative for pulmonary arterial hypertension (PAH); a rare, serious and life-threatening condition affecting the lungs and heart.

Camurus is expanding with good prospects of further growth and continued value creation. This is reflected by an increasing interest from both pharmaceutical companies and the international investor community, for instance, in connection with our presentations and at J.P. Morgan and Cowen and Co. Annual Health Care Conferences earlier in the year.

In parallel with the advances in our product pipeline, we are also building our commercial organization for the anticipated launch of CAM2038 in 2018. To support the business expansion, we have strengthened the management team and organization with new functions and expertise. Urban Paulsson, with broad and international expertise from the pharmaceutical industry, was recently appointed as VP Corporate Development & General Counsel, and Cecilia Callmer, previously at Novo Nordisk and Ferring Pharmaceuticals, has taken the position as VP Human Resources.

We have had a good start of the year, with the recent announcement of positive Phase 3 results, and are now about to enter the registration phase with CAM2038. We are also having good progress in other clinical programs and look forward to a continued positive news flow during the year.

Fredrik Tiberg
President and CEO

Management team


Board of directors


Code of conduct


 

Career


At Camurus, we value diversity, equality, and responsibility. We are an agile organization with a shared ambition for growth and an innovative and collaborative culture. Our operations are conducted from the modern, state-of-the-art laboratories and offices at our headquarters in Lund, Sweden.

Camurus is a knowledge-based company, and the know-how, innovation, and expertise of our employees is an essential part of our continued success. Passion, knowledge, and creativity are vital for attaining our goal: to offer patients and society new and improved treatments for serious and chronic diseases. The vast majority of Camurus’ employees work in research and development and many of them hold advanced university degrees. Our business and comprehensive expertise are continually developed through an active transfer of knowledge throughout our international network and through intense collaborations with academia and industrial partners. Camurus is a dynamic and exciting workplace, populated by devoted experts with outstanding skills in many fields of research.

Vacant positions

Camurus AB Ideon Science Park. SE-223 70 Lund, Sweden. Visiting address Ideongatan 1A. 223 62 Lund, Sweden.
Phone: +46 46 286 57 30 Fax: +46 46 286 57 39 Email Addresses General enquiries: info@camurus.com
Business Development: busdev@camurus.com Media: media@camurus.com Investor Relations ir@camurus.com