Camurus Ab

Thank you so much Einar and good day, everyone, and welcome to Camuri's full year and fourth quarter earnings call. Before starting, please note our forward looking statements. So we will begin the presentation today with the short business highlights, then review the financial performance, followed by commercial and R&D updates. And of course, then Q&A. As previously, I'm joined in the call by John Garay, CFO and Richard Jameson Chief Commercial Officer. Camurus had a rewarding 2024 with good performances across the business. This resulted in high growth and profitability alongside advances of key pipeline programs. In parallel, we continued the geographic expansion with the establishment of Camurus Inc. in the US. Importantly, we remain on track to deliver our five-year vision of five-fold revenue growth from 2022 and an approximate 50% operating margin in 2027. As a reflection of the solid performance during the year, we delivered continued strong operating revenue growth, as well as you can see on the right-hand side here, sustainable high profitability. Our fourth quarter results exceeded previous estimates, with Bovidal growing at double digit rate in owned territories and Brixari finishing the first full year with strong fourth quarter. Additionally, we established a fully operational US commercial organization as prepared for the launch of Oaklace in Akromegaly. On the development side, regulatory reviews of CHEM 2029 continued in the US and the EU. with a temporary setback in the US in the form of a complete response letter from the FDA relating to an inspection of a third party manufacturing facility. I will come back to this later in the presentation. In parallel with the regulatory reviews, our clinical studies Sorrento and Positano continue to advance. And before the new year, we initiated a new clinical study of our once monthly semaglutide GLP-1 product. On the corporate side, we delivered solid financial performance, positioning the company for further expansion and growth in 2025. And with this short introduction, I'll leave the word over to John for a financial update.

Thanks a lot, Fredrik, and good afternoon, everyone. During the quarter, Camurus continued its development, delivering a strong growth and financial performance. Now, I would like to share the key financial highlights of this quarter. At the end of the quarter, Camurus achieved 553 million SEK total revenue, delivering a growth of 48% versus same period last year, with product sales of 469 million SEK growing 28% versus prior year and 11% versus prior quarter. Additionally, Bricsaddy sales in the United States represented an 83 million SEK royalty income, growing 43% versus prior quarter. Looking at full year results, Camoros reached 1,868 million SEG total revenue, representing a growth of 9% versus prior year. Excluding one-time revenues in 2023 related to BRICS-ADI approval in the U.S. by FDA, total revenue grew 42% versus prior year, and BRICS-ADI royalty represented 212 million SEG. During 2024, the company achieved an earning per share after dilution of 7.20 Swedish kroner, equivalent to a profit after tax of 429 million SEK. And company cash position progressed positively, ending at 2.85 billion SEK. Moving to next slide, we can see the main components of our profit before taxes. Company gross margin reached 94% in the quarter, representing an improvement of 267 basic points versus same period prior year, driven by three major factors. Firstly, supply chain efficiencies, driven by Boogitar volumes scale-up, represented 181 basic points. Secondly, 96 basic points are driven by Bricsady royalty. And thirdly, FX represented a negative impact of 10 basic points. Total OPEX reached 357 million SEC representing a 4% decrease versus same period prior year driven by following factors. Marketing and distribution investment to support market penetration in own territories. Expansion of UBIDAL into new markets and US operations grew 40% to 157 million SEC. Administrative expenses aligned with corporate evolution to substantiate company development grew 48% versus same period last year to 25 million SEK. R&D investment reached 167 million SEK, decreasing 27% versus same period prior year, driven by lower social security costs related to long-term safety plans and lower study costs in our clinical trials. On a full year basis, R&D investment reached 684 million SEC, equivalent to 37% of total company revenue. During the quarter, the company explored a potential transaction incurring in one-time expenses of 8 million SEC regarding advisory fees that are reported in other operating expense lines. Company profit before taxes reached 186 million SEC, growing 204 million SEC versus Q4 23. On a full year basis, company profit before taxes reached 553 million SEK, which excluding one-time master revenue impact represents an improvement by 409 million SEK, increasing 286% versus 2023. Company cash position at quarter end was 2.85 billion SEK. Camurus improved its cash position by 101 million SEK during the quarter, driven by following four factors. Firstly, company operations generated 166 million SEK. Secondly, third window of ESOP 21-24 program generated 18 million SEK. Thirdly, working capital consumed 63 million SEK. And fourthly, investing activities required 20 million SEK. At the end of quarter, Camurus has no debt. Moving now to 2025 guidance, company has considered the following factors when providing 2025 financial guidance. Market conditions, the current microeconomic environment, continued investments aligned with the strategic vision 2027, in which we imply R&D will continue approximately flat in the level of 0.65 billion sec, and incremental investment of approximately 0.35 billion sec to fully deploy U.S. operation, launch workplace globally, and support company growth. Social security costs regarding company long-term safety programs will vary with the shared evolution. And from a capital expenditure point of view, company will invest about 0.2 billion SEC in the next two years to develop a second manufacturer to enhance manufacturing capabilities and support new product launches. Camur's full year 2025 outlook is as follows. Total revenues in the range of 2.7 to 3 billion SEC, representing a growth of 45% to 61%. Profit before tax in the range of 0.9 to 1.2 billion SEC, representing an increase of 63% to 117%. All in all, Camurus closes 2024 with a strong financial position, solid operational performance, interesting growth opportunities, and remains on track to deliver 4.5 billion SEC total revenue at circa 50% operating margin by 2027. Having said that, I would like to pass the word to Richard. Thank you everyone for your attention.

Thank you, John. So I will start with the business in Europe, Australia and the Middle East region. In the fourth quarter, the year finished strongly with Buberdale sales of 469 million sec, which was 11% versus the previous quarter and 28% over the previous year. For the full year sales of Buberdale were 1.65 billion sec, a growth of 27% versus previous year. And at the end of the year, we estimate that 60,000 patients were currently being treated with Buberdale. In the EU, this was led by the large European markets with UK, France, Germany and Spain. The strong performance was a result of continued execution of key programmes that drive penetration and improve access to Buvidal, resulting in continued market share gain and new patient recruitment across all geographies. In Australia, Buvidal is now established as a first-line treatment. The market share of long-acting buprenorphine in Australia is now estimated at 32% of all patients, and Buvidal has clear leadership in this segment. This is supported by the efforts to improve capacity and access for patients, for example, with a growing number of pharmacies that now have been trained or are now administering Buvidal, which creates space for new patients at clinics. Our market expansion continued and in the quarter we had three new reimbursement approvals that were received in Switzerland, Portugal and Luxembourg and will launch Buvidal in early 2025 in those countries. Additionally, four other regulatory applications are under review. Now moving across to the US, first a reminder of the US market, where there are an estimated six to seven million people with opioid use disorder, of which an estimated 2.3 million seek treatment in a year, and 1.8 million of those are on buprenorphine. In the fourth quarter, Brookside has strong growth. Net sales grew 43% versus previous quarter, resulting in royalties of 83 million sec and 212 million sec for the full year. The launch continues to outperform previous product launches in this segment. Patient capture was primarily from the large sublingual buprenorphine segment, while the remainder are transfers from other long-acting products and direct initiations into treatment by Brixardi. So 15 months from the initial launch, Brixardi market share has reached approximately 25% of that long-acting segment. And the peak market share potential for Brixardi is estimated to be above $1 billion. Now, to support both Buvedal and Brixardi, the evidence base for effectiveness in different treatment settings and the economic outcomes continues to grow. In the quarter, we have three important publications. First was an exploration of treatment outcome by quantitative urine measures that shows emphasised treatment effect in patients using high level of opioids. Secondly, a naturalistic study showed a clear preference from patients for brixadi injection over other long-acting injectables. And finally, a paper that explored healthcare professional perceptions that showed high satisfaction for long-acting buprenorphine compared to both methadone and daily sublingual buprenorphine. And this growing evidence base continues being shared for our wide-ranging medical education programmes and at leading Congresses. And on that note, I'll hand back to Fredrik for an R&D update.