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 FOURTH QUARTER AND FULL YEAR 2020

Positive sales and pipeline development
despite Covid-19 headwind


CEO STATEMENT

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



Camurus continued to deliver strong results in the fourth quarter of 2020. Net sales increased by 201%, and product sales by 243% compared to Q4 2019. The expansion of the Buvidal® market continued with price and reimbursement approvals in Spain, regulatory approval in Switzerland, regulatory approval applications in Kuwait, the UAE and Saudi Arabia, while at the end of the quarter, the anticipated approval of Brixadi™ in the US was delayed when Braeburn received a Complete Response Letter from the FDA. Our product development for other chronic conditions intensified, with Phase 3 programs for CAM2029 in acromegaly and neuroendocrine tumors advancing according to plan, and the initiation of treatment of patients in new clinical studies of CAM2029 and CAM2043.


During the fourth quarter of 2020, we continued to deliver significant sales growth in line with our upgraded guidance from June and advanced our priority development programs and late-phase clinical studies. This is despite the ongoing Covid-19 pandemic that has presented significant challenges for our teams, customers, and partners. Sales of Buvidal were SEK 104 million, an increase of 243% compared to the corresponding quarter of 2019. Compared to the previous quarter, product sales increased by 10%, while the actual growth in our markets in Europe and Australia was 33%. This difference was due to quarterly shifts between invoiced and in-market sales, which on a full year basis were aligned.

Buvidal is now available in 15 countries with more than 15,000 patients in treatment, and over 200,000 administered doses, which is a solid basis for continued growth in 2021. All markets in Europe and Australia exhibited double-digit quarterly sales growth for Buvidal. Sales in the Nordic region, Australia and the UK continued to impress, and positive trends with accelerating growth were seen on other markets, as we continued to improve the access to treatment with Buvidal. In 2021, new markets will start to contribute to the growth, including Spain, where price and reimbursement approval for Buvidal was granted in December 2020.

In addition, we are seeing an interest in Buvidal among patients, healthcare providers and decision makers, reinforced by the attention Buvidal has received in regional and national media1-4. However, Covid-19 continues to limit our ability to interact and provide education to different stakeholders, which in some countries also hampers the recruitment of new patients and the prescription of Buvidal.

In MENA, Buvidal is available in three countries through so-called early access programs and we currently have some hundred patients in treatment through these programs. In order to expand the availability of treatment, we, together with our partners, are applying for regulatory approvals in the region. During the fourth quarter, market authorization applications have been submitted in Kuwait, the UAE and Saudi Arabia, where we also received priority review status from the Saudi Medicines Agency, which means a shortened processing time. Additional applications in MENA are planned in 2021.

In Switzerland we received approval for Buvidal for treatment of opioid dependence by Swissmedic, while the final assessment is ongoing in New Zealand after positive preliminary recommendation. Furthermore, life-cycle management applications are under review in both the EU and Australia with the aim to expand the label and use of Buvidal in the treatment of opioid dependency. Approval decisions are expected during the second quarter 2021. In parallel, preparations for the registration of Buvidal/CAM2038 for the treatment of patients with severe chronic pain continue. In addition to progress on the regulatory side, several investigator-initiated studies of Buvidal in Europe, Australia and the US are underway and the protocols for two of these were published during the quarter5-6. The publication of the positive results for the DEBUT and UNLOC-T studies are expected in the first half of 2021.

Approval process for Brixadi™ in the US
In the US, we had looked forward to a final approval of Brixadi on December 1, 2020, but instead received the unexpected news from our partner Braeburn that FDA had issued a Complete Response Letter in respects of quality-related observations made during a pre-market inspection of Braeburn’s third-party manufacturer. Based on the information received from Braeburn and the FDA, our experts’ assessment is that the observations should be manageable and that a new approval decision may come in the second half of 2021. During the fourth quarter, we also received a ruling from the Arbitration Tribunal from the accelerated arbitration process initiated by Braeburn over the summer of 2020.
The Tribunal ruled that Braeburn was not in material breach of the license agreement at the time of Camurus notice. Therefore, the parties’ respective rights and obligations under the License Agreement continue be in full force, including Braeburn’s obligation to develop, register and commercialize CAM2038 in North America, as well as related financial terms.

Phase 3 studies of CAM2029 in acromegaly and NET
During the quarter, we continued to advance the registration programs for CAM2029, long-acting octreotide, for the treatment of acromegaly and neuroendocrine tumors (NET). The recruitment of patients in the ongoing Phase 3 studies of CAM2029 for the treatment of acromegaly is proceeding according to plan. To ensure that the Covid-19 pandemic does not affect the running of the studies, our clinical teams, in collaboration with the clinics concerned, have developed and implemented a range of measures to facilitate the participation of patients and clinical staff. The ability for patients to easily dose CAM2029 themselves is in this context a clear advantage over currently available treatments. This will be further strengthened when the new autoinjector is fully validated and included in the Phase 3 long-term study around mid-2021. During the quarter, the dosing of participants was initiated in a Phase 1 clinical study of CAM2029 administered with autoinjector and prefilled syringe, respectively. In addition, we performed a formative user study (human factor engineering trial) with the autoinjector in patients and caregivers for upcoming submissions for regulatory approvals of CAM2029 in acromegaly, planned for H2 2022. Preparations for the start of the Phase 3 study of CAM2029 for the treatment of NET have also advanced during the quarter after discussing and agreeging the study design with the FDA in a Type B meeting. The study, which is an international, multicenter study evaluating treatment efficacy with CAM2029 and the current standard treatment, is scheduled to begin in the first half of 2021, and will include a total of approximately 350 patients. In addition to acromegaly and the NET programs, preparations are also underway for meetings with regulatory authorities regarding the development of CAM2029 for the treatment of polycystic liver disease.

Progress of extended release treprostinil and setmelanotide clinical programs
In the fourth quarter of 2020 we started a Phase 2 study of the subcutaneous weekly depot of treprostinil, CAM2043, for the treatment of Raynaud’s phenomenon. Due to the worsening situation with Covid-19 in the UK, recruitment of new patients in the study has temporarily stalled and will resume as soon as the situation has improved, and new patients can be included. Even with this delay, we expect the study to be completed and results reported in 2021.
Our partner Rhythm received US approval for Imcivree™ (setmelanotid) for three genetically conditioned states of severe obesity during the fourth quarter7. Following positive Phase 2 results for our weekly formulation of setmelanotide, Rhythm has continued preparations for start of registration studies for the weekly product in the second half of 20218.
All in all, this means that we can have four registration programs for drug candidates based on FluidCrystal® technology up and running in 2021, which is very positive and a strong validation of our technology platform and development portfolio.

Strong development of Camurus’ results and pipeline
Despite Covid-19 challenges, Camurus continued to deliver strong results in the fourth quarter, with increasing market shares for Buvidal, expansion into new markets, and advances in the R&D pipeline. We ended 2020 with a strong cash position and foresee a positive development of our business in 2021, as we continue to strengthen our leading position in opioid dependence treatment, develop our late-stage drug candidates towards the market, and work actively with business development to expand our portfolio of innovative medicines for serious and chronic diseases.
I would like to extend my warm gratitude to our employees, collaborations, clinicians, and study participants who in different ways have contributed to Camurus’ success during a year with significant challenges.

Fredrik Tiberg
President and CEO

References
1. https://www.walesonline.co.uk/news/politics/ game-changing-new-drug-being-19178350
2. https://www.bbc.co.uk/news/uk-scotland54433312
3. https://yle.fi/uutiset/3-11719162
4. https://www.smh.com.au/lifestyle/life-andrelationships/marianne-taught-me-everyonematters-the-doctor-who-broke-a-drug-user-s-25- year-addiction-20201020-p566rr.html
5. Winhusen T, Lofwall M, Jones HE, Wilder C, Lindblad R, Schiff DM, Wexelblatt S, Merhar S, Murphy SM, Greenfield SF, Terplan M, Wachman EM, Kropp F, Theobald J, Lewis M, Matthews AG, Guille C, Silverstein M, Rosa C. Contemp Clin Trials. 2020; Online ahead of print https://doi.org/10.1016/j. cct.2020.106014
6. Schulte B, Lehmann K, Sybille Schmidt C, Rühling E, Weber B, Schäfer I, Reimer J, Verthein U. Front Psychiatry 2020; Online ahead of print https:// doi.org/10.3389/fpsyt.2020.580863
7. https://ir.rhythmtx.com/news-releases/newsrelease-details/rhythm-pharmaceuticalsannounces-fda-approval-imcivreetm
8. https://ir.rhythmtx.com/static-files/a80f3f4c55ec-45e2-ac68-9605deb5e63b

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