Camurus Ab

good day everyone and thank you for taking the time to join our first earnings call for 2024. so before starting the presentation please notice our forward local statements so the agenda for today's call includes first quarter highlights financial results we will then move to commercial and pipeline updates and finish off with a q a And with me on the call today, as previously, are John Garay, our chief financial officer, and Richard Jameson, our chief commercial officer. So starting out with our highlights in the quarter, cameras had a productive first quarter with strong profitability and pipeline progress. Total revenues grew by 37% year-on-year to 390 million SEC, which is the midpoint of our provided guidance. with profit before tax in the quarter of close to 100 million SEK. Our financial position was further strengthened by a successful directed share issue to support inorganic growth opportunities, accelerate U.S. commercial preparations for CAM 2029 in neuroendocrine tumors and polycystic liver disease, and enhance our manufacturing capabilities. From a commercial perspective, we continued strengthening our leading position in opioid dependence treatment across geographies. Buvidal sales increased by 29% year-on-year to 364 million SEC at reported rates. In the U.S., Brixadi showed strong and accelerating growth, resulting in an approximate threefold increase in sales and royalty in the first quarter versus Q4 2023. So on the R&D side, we received FDA acceptance for the review of MDA for Oclase in acromegaly with a PDUFA date in October this year. A corresponding application has now been submitted to the EMA. And outside the acromegaly area, we progressed the Sorento study of CAM-2029 in neuroendocrine tumors and completed patient recruitment in the Positano trial in polycystic liver disease. Importantly, we also advanced several early development programs, including completing preclinical assessments of a novel monthly formulation of semaglutide. Based on the data received, we are preparing for a first clinical study, planned to be started towards the end of this year. And with this short introduction, I will hand over to John for the finances.

Thanks a lot, Fredrik, and good afternoon, everyone. During this quarter, Camurus continued its development, delivering a strong profitability and remaining on track to meet 2024 market guidance and 2027 vision. I would like to share now key highlights of our financial performance this quarter. Camurus achieved 390 million SEG total revenue in the quarter, delivering a growth of 37% versus same period last year with product sales of 364 million SEC growing 29% versus prior year and basically aligned with prior quarter. Swedish Kronor appreciation has impacted negatively reported figures by 1% year-on-year basis and 3% versus prior quarter. Bricsaddy sales in the U.S. represented a 26 million SEC royalty income in the quarter following its commercial launch of September last year. Company profit before taxes was 97 million sec, achieving an earning per share after dilution of 1.32 Swedish kronor, equivalent to a profit after tax of 78 million sec in the quarter. Finally, our cash position progressed positively during the quarter, ending at 2.3 billion sec, including 1,026 million sec obtained via a directed share issue carried out in January in the size of 2 million shares. Moving to next slide, we can see the main components of our profit before taxes. Company gross margin reached 92.1% in the quarter, representing an improvement of 222 basic points versus same period prior year. The improvement was driven by three major factors. Supply chain efficiencies, driven by Boobidal volumes scale-up, represented 200 basic points. Secondly, 60 basic points are driven by Brixa deroyality. And thirdly, FX represented a negative impact of minus 45 basic points. Total OPEX reached 289 million SEC, representing a 57% increase versus same period prior year, driven by following factors. Marketing and distribution investment to support marketing penetration in owned territories, expansion of Boobidal into new markets, and U.S. operations grew 23% to 93 million SEC. Administrative expenses aligned with corporate evolution to substantiate company development grew 73% versus same period Asia to 16 million SEC. R&D investment reached 180 million SEC Growing 81% versus same period prior year, driven by recruitment completion, and progress in our preclinical and clinical pipeline. Company profit before taxes reached 97 million SEG, growing 26% versus prior year. Company cash position at quarter end was 2.3 billion SEG. Camorus improved its cash position by 1,084 million SEC in the quarter, driven by following factors. Firstly, company operations generated 139 million SEC. Secondly, working capital increased by 102 million SEC, driven mainly by inventory and receivables growth. Thirdly, company carried out a direct share issue, providing net proceeds of 1,026 million SEC after transaction cost. And finally, the company executed AGM 2021 authorization to hedge employee stock option social security costs, obtaining 22 million SEK. As end of quarter, TAMURUS has no debt. All in all, TAMURUS closes first quarter 2024 with a strengthened financial position interesting growth opportunities, and is on track to deliver 2024 market guidance. Having said that, I would like to pass the word to Richard. Thank you, everyone, for your attention. Thank you, John.

So, we move over to a commercialization update. I'll start in the cameras markets, and then I will give an update on Brixardi in the U.S. So, in quarter one, invoice sales for Buvedal grew at plus 29% versus previous year at 30% at constant exchange rate. and plus 3% versus Q4, a constant exchange rate. After a strong Q4, we saw softer sales in January and February. However, as expected, in March, we exited the quarter strongly. Importantly, though, underlying in-market demand remained strong and grew at 5% quarter-and-quarter, which more accurately reflects performance in the countries. Sharpened execution on our strategies and plans by the team across countries is driving both access to Buvidal and penetration in clinics and criminal justice settings. And we continue to hear of the positive impact that Buvidal is having on treatment outcomes for patients with opioid dependence. To give some more granularity, we had good progress in the UK, where in market we continue to grow to high single digit and recruit new patients alongside accelerating access in criminal justice settings as NHS funding comes through. But that said, this was tempered slightly by delays in that NHS funding due to the NHS year end that finished in March. In Australia, the recent government changes have reduced co-pay for patients, and we see both numbers in treatment and the numbers on long-acting injectable buprenorphine growing, and we maintain our strong leadership in the long-acting buprenorphine segment with patient share above 80%. Also in the Nordics, France, Spain, and the MENA region all grew well in the quarter, and we remain on track for our market guidance for product sales. We now estimate we have more than 50,000 patients being treated with Buvidal at the which is approaching 30% of the Buprenorphine segment where we have access, though, of course, with an estimated 750,000 patients in treatment in Europe and Australia, there remains a large opportunity for Buvidal in the region. We also continue to expand geographically, and in Q1 achieved reimbursement approval in Ireland, which will allow us to expand Buvidal use in treatment clinics across the country, and we have ongoing processes for both reimbursement and market authorizations in other countries. Now moving to the U.S. with the launch phase of Brixardi. Performance in the quarter in the U.S. saw accelerated penetration as shown by the large increase in our royalty stream from partner Braeburn. Royalty for the quarter was 26 million sec and based on information from Braeburn, after about six months since launch there we already have an estimated 7,000 patients on treatment with Brixardi. This excellent early progress reflects the acceptance of the strong product profile and demand for Brixardi in the country with a high unmet medical need. The compelling messaging around Brixardi is clearly resonating with U.S. healthcare professionals, and Braeburn continue to focus on the launch strategy and execution with a commercial team of more than 100 people. And they have strong payer coverage already on par with other long-acting injectable products in OUD and a channel development that provides quick and reliable access to Brixardi. And based on the strong performance of Brixardi in the U.S., our expectations of reaching peak sales above 1 billion has been reinforced. We also continue to build and share the evidence base to highlight the advantage Buvidal brings for those seeking treatment for opioid dependence and data that supports a differentiated product profile. Firstly, a recent publication on opioid blockade affirms the need to individualize treatment and titrate doses for optimal treatment outcomes and demonstrated blockade across the dose range for Buvidal and Bruxardi. Other publications from Australia show how long-acting buprenorphine is individualized in the country with broad utilization of all treatment doses in real clinical practice. So on that note, I will hand back to Fredrik for an update on the pipeline.