Camurus Ab

Thank you so much and good day, everyone. Welcome to our last earnings call for 2022. It's a great pleasure today to be able to present strong fourth quarter and full year results, along with significant progress of our business. I will assume you have read our forward looking statements. And with this note of caution, let's move into today's agenda. We'll start with a summary of our achievements in 2022 and the fourth quarter, then go over to the financial results and the 2023 outlook, followed by commercial and R&D pipeline developments. We'll then finish off with a summary of the quarter, upcoming milestones in 2023 before going to Q&A. So in previous calls with me today is our Chief Financial Officer John Garay and Chief Commercial Officer Richard Jameson. So as I already alluded to, 2029 was a very successful year for Camrys where we, for the first time and ahead of plan, entered profitability. driven by growing revenues and gross margin improvements. Our total net revenue increased by 59% to 156 million and the operating results increased from a minus of 112 million SEK to a positive result of 72 million SEK. This while also investing around half a billion in the R&D pipeline and future growth of the company. We continued strengthening our leadership in long-acting opioid dependence treatment across Europe, Australia and the MENA. I received three new regulatory approvals and five pricing and market access approvals during the year. Bibidol is now available in 20 countries. and the geographic expansion continues. On the R&D pipeline side, four phase three trials progressed during the year, and we also started a new clinical program in polycystic liver disease. I'll go in more about this in a few slides, but let's first zoom in on the fourth quarter highlights. So in the quarter, we delivered double-digit revenue growth versus previous quarter. It was our fourth consecutive quarter with positive operating results and the third with profits. We received the first biblical orders from Egypt and Saudi Arabia after Q3 approvals. And on the other side of the Atlantic, our U.S. licensee, Braeburn, resubmitted the MDA for Brixadi, which shortly thereafter was accepted for review by the FDA. with the PDUFA dates coming up later here in May. So moving in then to R&D, we completed recruitment in our pivotal phase three trial of CAM 2029 in ACRO and passed the milestone of 100 patients randomized in the Sorrento phase three trials in gastroenteropancreatic neuroendocrine tumors. As presented in our Capital Markets Day in September, we also worked diligently to strengthen our sustainability framework. Here we worked with implementing an updated sustainability strategy, covering ESG aspects throughout our business processes. We strengthened our management with a new experienced head of corporate compliance, Jonas Duborn. and the director of sustainability, Edith Rehnström, as well as new members of Canberra's team. Examples of more specific activities in the quarter were medical education efforts for healthcare professionals in Ukraine to support treatment with Duvidal, which was donated at the request of the Ministry of Health. And the first patients are now starting treatment or have started treatment. We also supported several disease awareness campaigns, worked with ESG monitoring and reporting in the supply chain, and introduced the whistleblowing digital platform. Going forward, we will continue to drive new initiatives in our sustainability focus areas, as you can see here on the right hand side. So with this brief intro, I will hand over to John to give an update on the financial performance and outlook for 2023.

Thanks a lot, Fredrik, and good afternoon, everyone. We would like to share with you now the main highlights of our financial performance this quarter. If we move to the next slide, we can see the main components of our operating result, once revenue has already been covered by Fredrik. Gross margin improved 496 basic points in the quarter, driven by, firstly, scrap reduction in our operations, delivering 260 basic points, and secondly, better country price mix and efficiencies of higher volumes delivered in the rest. In total, gross margin delivered 240 million SEC in the quarter, where full year gross margin reached 89.2%. Total OPEX reached 223 million SEK, a 28% increase versus same period prior year, driven by following three factors. Marketing and distribution investment to support market penetration in own territories and expansion of Wubidal into new markets. Administrative expenses aligned with corporate evolution to substantiate company development. And thirdly, R&D progress in the three indications of our CAN 2029 program, where acromegaly patient recruitment was completed during early Q422. On a full year basis, R&D investment has been 474 million sec, aligned with half a billion sec range indicated earlier this year. Company operating result became positive by 19 million sec in the quarter and 72 million sec full year. This was mainly driven by sales growth and gross margin improvement. Profitability may fluctuate between quarters as we continue investment in our pipeline to bring product candidates to market as soon as possible. If we now move to next slide, our cash position at quarter end was 566 million SEC delivered in a 37% growth versus same period prior year. Camurus generated 46 million SEC cash in the quarter, mainly driven by company operations generating 32 million SEC Improvement in working capital generating 14 million SEK and warrants program exercise by employees generating 4 million SEK. As end of quarter and year, Camurus has no debt. Our guiding principles for capital allocation continue being reinvesting in our business to accelerate movable market penetration and geographical expansion, as well as bringing Can2029 to market as planned, And secondly, support our company strategy in the area of inorganic growth opportunities enhancing our company value. If we now move to 2023 financial guidance, we expect company revenues in the range of 1,530 million SEC to 1,650 million SEC, including anticipated milestone payment following BRICSAD's NDA approval in the United States by a value of $35 million. and profit before taxes in the range of 425 million SEK to 525 million SEK. Company guidance is taking following considerations into account. From a total revenue point of view, potential downward pressures due to austerity measures implemented by some governments are at risk, and we are planning to address certain market access hurdles. From a strategic investment point of view, While Camurus is ahead of profitability when compared to our long-range plan 2027, company will continue to invest during 2023 somewhat more than during 2022 to support our strategic vision in following areas. Incremental R&D investment to bring CAM 2029 to market the sooner the better in the range of 0.1 billion SEC versus prior year, and new proprietary development relating to fluid crystal technology, U.S. organization development, systems upgrade, and structural development to support company growth in the range of 0.1 billion SEC versus prior year. All in all, Camurus closes 2022 with a solid financial position, interesting growth opportunities, and is on track to continue its growth in line with the long-range plan vision shared at September Capital Markets Day. Having said that, I would like to pass the word to Richard. Thank you, everyone, for your attention.

Thank you, John. So move up to a commercial development update. We ended the year with record Buberdale sales in the quarter of 267 million sec, which corresponds to an increase of 57% year over year and 11% versus the previous quarter. Quarterly growth returned to double-digit growth after a slowing in Q3 due to the holiday period. In Asia-Oceania, we saw growth of 22% and Europe 4%. However, this was mainly driven by stock levels at wholesaler year end. And it's important to note that the underlying in-market Bufordale growth in Europe was 16% versus the previous quarter. Growth was seen across markets with large contributions in revenue from our established markets. Notably growth in the UK and specifically England accelerated as the anticipated new funding to improve the treatment system started to become available at clinic level. Also the newer markets saw good growth, particularly Belgium after we extended the reimbursement conditions and Spain as we have addressed the majority of the access hurdles at a regional level. And our market expansion also continued. As Frederick said earlier, Buvidal is now available in 20 countries across Europe, Australia and MENA. And in the quarter, we finalized the first two orders for two major MENA markets in Egypt and Saudi Arabia, where Buvidal is the first approved maintenance treatment for opioid dependence. So we finished the year with more than 36,000 patients currently being treated with Buvidal and we continue to receive very positive feedback from all our markets and the impact Buvidal is making to improving patient outcomes. And looking ahead, we expect several new markets to open in 2023 to further our expansion with five market authorization applications under review and six PMA submissions. We also updated yesterday on the withdrawal of the variation application to extend our current label opioid dependence label to include chronic pain after the CHMP request for additional data and internal analysis. The withdrawal, as we said, is not expected to affect CAMRAS financial results in 2023 or to a significant extent impact the company's long-range financial plan. CAMRAS is evaluating further clinical development of count 2038 in the treatment of chronic pain, taking into consideration the positive phase three results and the fact that this patient population of the variation that we apply for already has access to Bufadil for the treatment of their opioid dependence. Finally, importantly, we look forward to the approval decision for Brixardi in the US later in the year. As we communicated previously, Braeburn has an FDA acceptance of the Brixardi resubmission and a PDUFA date of the 23rd of May, with potential launch soon thereafter. The opportunity in the U.S. is, of course, substantial with around 1.4 million patients currently treated with buprenorphine. And whilst long-acting injectable products are growing fast with a market size in excess of $800 million, they still have low penetration with less than 5% of patients on a long-acting treatment. Additionally, the market environment is improving as measures are taken to further address the opioid crisis. There's been recent increased funding in state grants alongside an important change in legislation This led firstly to the elimination of data waiver for the prescribing of buprenorphine and the removal of the restriction on the number of patients a physician can treat with OUD. These changes will increase the availability of buprenorphine for treatment and remove a key barrier for prescribing a potentially life-saving medication. Brixardi and Bovedal in Europe is clearly differentiated and well-positioned in the long-acting injectable segment with some clear advantages over other formulations, including initiation of treatment, individualized dosing, both weekly and monthly formulations, and multiple injection sites. And you can see this outlined on the table on the right. So we look forward to BRICS-RDB becoming available to U.S. patients. And on that, I will hand back to Frederick for the R&D pipeline update.