Strong growth and finish to 2021
Camurus had a successful fourth quarter in 2021 with record sales of SEK 181 million and increased growth of 19 percent compared to the previous quarter. We submitted a regulatory application to the European Medicines Agency for extended approval of Buvidal® to include the treatment of chronic pain, initiated dosing of CAM2029 in a Phase 3 study in patients with neuroendocrine tumors, and continued to advance two Phase 3 studies in acromegaly. An otherwise positive year ended with the news in December that our US licensee Braeburn had received a new Complete Response Letter for Brixadi™ from the FDA.

Strong growth and result improvement during the fourth quarter
Total revenues during the fourth quarter were SEK 183 million, and SEK 601 million for the full year, an increase of 79 percent compared to 2020. Operating profit was SEK -18 million for the fourth quarter, up 78 percent, and SEK -111 million for the full year.

With growing revenues, several products in late stage development and a healthy cash position of SEK 412 million, we have excellent conditions to deliver on our strategy for continued growth and value creation through development and commercialization of innovative medicines for the treatment of severe conditions in opioid dependence, chronic pain and rare diseases.

Product sales during the quarter were SEK 181 million, an increase of 74 percent compared with the previous year and 19 percent over the last quarter. Full year sales ended at SEK 594 million, an increase of 84 percent compared with the previous year. We saw strong growth in the UK, Sweden, Finland and Australia, while sales in Norway and Germany continued to be impacted by the ongoing pandemic. Progress also continued in our newer markets, including France and Spain, where we experienced high growth from relatively low levels. The strong sales during the fourth quarter are credit to our teams and a growing awareness of Buvidal among decision makers, healthcare providers and patients. The weaning impact of the Covid-19 pandemic on our markets has also enabled us to increase our engagement with stakeholders. In light of the significant challenge we faced during the year, I am pleased with the sales development and that we have delivered double-digit sales growth ten quarters in a row. By the end of the year, Buvidal was available in 17 countries with close to 25,000 patients in treatment.

New funding initiatives for opioid dependence treatment
In 2022, we will continue strengthening the position of Buvidal in the opioid dependence treatment landscape. This is based on the positive feedback we continue to receive from patients and healthcare providers, new scientific publications demonstrating the value of Buvidal to patients and society, government reports and new funding initiatives, and reimbursement and regulatory approvals. We expect to see improved access to treatment in key markets along with continued geographical expansion.

As an example, the UK government recently published a 10-year drug strategy “From Harm to Hope” with the goal of creating a world-class treatment system. To achieve this, GBP 780 million has been allocated in additional funding for drug dependence treatment in England ¹, and in Scotland the government has allocated GBP 250 million to address the growing overdose crisis.² In both cases, long-acting buprenorphine is mentioned as part of the strategy to improve care for patients with opioid dependence. New funding for Buvidal has also been allocated in Wales, Denmark and France.

During the quarter, we also received a positive reimbursement decision in Belgium, where we are now broadening our operations, after having previously been focused on the criminal justice system. In 2022, additional price and regulatory approvals are expected, further increasing the availability of Buvidal in Europe, the Middle East and North Africa.

Overall, we expect continued solid growth in 2022 with annual sales of Buvidal of between SEK 875 and 925 million.

Brixadi in the US
To our disappointment, our US licensee Braeburn informed us that they had received a new Complete Response Letter (CRL) on 15 December 2021 for their updated New Drug Application (NDA) for Brixadi™ for the treatment of opioid use disorder. The CRL was the result of continued quality-related deficiencies at Braeburn’s contract manufacturer in the US.

Since learning of the CRL, we have been seeking information from Braeburn about the CRL, how this is being addressed, and the estimated time to resubmission of the NDA. We will provide an update as soon as new substantive information is made available and can be communicated.

EMA acceptance of chronic pain submission for Buvidal
In our own markets, our work continued to expand approval of Buvidal to include treatment of chronic pain. A regulatory application was submitted to the European Medicines Agency (EMA) and accepted for review on 27 November 2021. Review is ongoing and an opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected in the second half of 2022.

Treatment of chronic pain is considered one of the biggest challenges in healthcare.^3,4 Opioids provide effective pain relief, but long-term use is associated with an increased risk of dependence.^3,5 The medical need in chronic pain is significant, especially among people who are dependent on opioids, of whom 33-55 percent are estimated to suffer from chronic pain.^6,7

With extended approval, Buvidal could become an important treatment option for patients with chronic pain in addition to the current indication for the treatment of opioid dependence. With weekly and monthly doses and a long-lasting effect the need for daily medication can be reduced, which can improve treatment adherence and minimizes the risk of medication diversion and misuse.

Continued progress in the development pipeline
During the period, we have continued to advance our latestage pipeline. Patient recruitment progressed in the two Phase 3 studies of our subcutaneous octreotide depot (CAM2029) for the treatment of acromegaly. Our clinical teams have successfully handled the significant challenges of Covid-19 and now randomized more than one hundred patients in the studies. The goal is to complete recruitment during the spring and the pivotal efficacy study in the second half of 2022.

We initiated dosing in a third Phase 3 study of CAM2029 in patients with neuroendocrine tumors in the gastrointestinal tract or pancreas (GEP-NET). The SORENTO study is a randomized, active-controlled, multi-center study with the primary objective to demonstrating superior treatment efficacy with CAM2029 compared with current standard of care. The study aims to include over 300 patients in more than ninety clinical centers, mainly in the US, Canada and Europe. Topline results are expected towards the end of 2024.

Furthermore, we received positive pharmacokinetic results from our Phase 1 bridging study of CAM2029 with our new injection pen. The study demonstrated that the octreotide plasma concentration for the two product devices, injection pen and pre-filled syringe, were comparable. Moreover, the pen met our requirements and specifications for ease of handling and injection time and is now being introduced in all clinical programs, after also have concluded necessary human factor studies.

In addition to the acromegaly and GEP-NET Phase 3 programs, preparations are underway for the start of a Phase 2/3 study of CAM2029 for treatment of polycystic liver disease (PLD), for which there is currently no approved medical treatment available in Europe or the US. The development of a new patient reported outcomes questionnaire was completed and aligned with the FDA. This will now be implemented in the clinical study, which is expected to start within the next few months.

Start of Phase 3 studies of setmelanotide weekly depot in patients with genetic obesity diseases
During the fourth quarter, our licensing partner Rhythm initiated a randomized, double-blind, Phase 3 study of weekly depot setmelanotide for the treatment of obesity linked to rare genetic deficiency diseases, including Bardet-Biedl’s (BBS) syndrome. The product is based on Camurus’ FluidCrystal® injection depot and is being developed to offer patients a simpler and more comfortable dosing regimen with the possibility of improved treatment adherence. The first patients were randomized and dosed after the new year. The study will include 30 patients previously enrolled in Rhythm’s long-term, open-label extension trial. The primary effecacy measure in the study is the proportion of patients with no weight gain after switching from daily medication.

In addition to this switch study, Rhythm plans to initiate a second Phase 3 study of the weekly setmelanotide product in patients with BBS who have not previously received treatment.

Aside from the significant progress with our Phase 3 programs, treatment was completed in our Phase 2 pilot study of weekly treprostinil in Reynaud’s phenomenon, with results expected in Q2 2022.

A positive fourth quarter sets the tone for 2022
Camurus had a strong fourth quarter, with increased sales growth, improved result, new long-term funding initiatives for treatment in our markets and progress in our research portfolio and partnerships. This gives us a solid foundation to execute on our long-term strategy and reach profitability during 2022. We will continue to invest in our organization, infrastructure, technology, and a growing product portfolio of innovative product candidates for the treatment of severe and chronic diseases. Including the partnership with Rhythm, we expect to have at least five ongoing Phase 3 studies in 2022.

The company’s most important asset is our employees and culture. During the year we have had the pleasure of welcoming many new talented employees to Camurus as we continue to grow and strengthen our organization.

To enhance our status as an attractive employer and inspiring workplace, we have during the quarter launched new initiatives to evaluate, discuss and further develop our organization, processes and corporate culture.

We have also completed a comprehensive review and implemented a plan that will form the basis of a focused investment in sustainability in 2022.

In summary, we are well prepared as we now enter a new phase with a focus on growth and international expansion, business development, new approvals and product launches in chronic pain and rare diseases.

Buvidal - Buprenorphine Injection