Camurus Ab

Go ahead. Thank you so much. And good day, everyone. Thank you for joining. It's a pleasure to report on Canberra's second quarter earnings today. Before starting, please note our forward looking statements. So the agenda for today's call will be a short summary of second quarter highlights, followed by a review of financial performance. We will then move to commercial and R&D pipeline updates. and finish off with Q&A. And with me in the call today, it's like previously, is John Garay, our CFO and Richard Jameson, Chief Commercial Officer. So we had a solid second quarter with strong operational performance across the business. This resulted in a positive financial development. Our revenues in the quarter were 445 million SEK. representing a 46% year-on-year growth, excluding a one-time revenue from the US approval of Bricsaddy in 2023. Profit before tax in the quarter was 104 million SEK and 201 million for the first half year. Our cash position at the end of the quarter grew to 2.6 billion SEK with no debt in the company. Commercially, we continued advancing our global leading position in the opioid dependence treatment area. Moving on, sales grew to 400 million SEK in the quarter. In the US, the adoption of Brixadi continued to be strong and royalties increased by 73% quarter on quarter to 45 million SEK. In R&D, we progressed our pipeline according to plan. EMA issued an acceptance for review of our market authorization application for CAM2029 in Acromegaly. And in parallel, FDA's review of the corresponding new drug application for CAM2029 advanced towards the PDUFA date in October. On the clinical side, the core phase of the Acrinova2 study was completed. I'll present some of the results later here. with final results announced yesterday. We also completed our preclinical studies for once monthly semaglutide and are preparing for a planned start of clinical study by the end of the year. So overall, we had a very productive second quarter with significant progress across our business. And with this positive initial remark, I leave the word to John for a financial review.

Thanks a lot, Frederic, and good afternoon, everyone. During the quarter, Camurus continued its development, delivering a strong profitability and remains on track to achieve 2027 vision. I would like to share now key highlights of our financial performance this quarter. At the end of the quarter, Camurus achieved 445 million SEG total revenue compared to 674 million SEG in the same period prior year. Excluding 369 million SEC one-time revenues driven by Brixadi FDA approval in 2023, company revenues grew by 139 million SEC, delivering a growth of 46% versus same period last year. Boobidal sales reached 400 million SEC, growing 31% versus prior year and 10% versus prior quarter. Swedish kronor depreciation has impacted positively reported figures by 3% year-on-year basis and 4% versus prior quarter. Brixari sales in the US represented a 45 million SEK royalty income in the quarter, representing a 19 million SEK improvement versus prior quarter. Company profit before tax was 104 million SEK, achieving an earning per share after the illusion of 1.25 Schroeder-Schruner equivalent to a profit after tax of 74 million SEK in the quarter. Moving to next slide, we can see the main components of our profit before tax. Company gross margin reached 92.9% in the quarter. Excluding one-time revenues impact, it represents an improvement of 233 basic points versus same period prior year, driven by three major factors. Firstly, supply chain efficiencies driven by Buvidal volumes scale-up represented 171 basic points. Secondly, 83 basic points are driven by Briggs-Addy royalty. And thirdly, FX represented a negative impact of 21 basic points. Total OPEX reached 331 million SEC, representing a 23% increase versus same period prior year, driven by following factors. Marketing and distribution investment to support market penetration in own territories, expansion of Boveda into new markets and US operations grew 39% to 131 million SEC. Administrative expenses aligned with corporate evolution to substantiate company development grew 97% versus same period last year to 24 million SEC. R&D investment reached 174 million SEC, growing 8% versus same period prior year, driven by progress in our preclinical and clinical pipelines. Company profit before tax reached 104 million SEC. Excluding one time revenues impact, it represents an improvement by 92 million SEC, increasing 763% versus same period prior year. Company cash position at quarter end was 2.6 billion SEC. Camurus improved its cash position by 293 million SEC in the quarter, driven by following four factors. Firstly, company operations generated 155 million SEC. Secondly, working capital increased by 56 million SEC, driven by receivables growth mainly. Thirdly, financing activities mainly driven by exercise of stock option program by our employees delivered 196 million SEK. And finally, company invested 2 million SEK in technological activities. As end of quarter, Camurus has no debt. All in all, Camurus closes second quarter with a strong operational performance and solid financial position. Camurus reiterates its 2024 financial outlook and expects to finalize in the mid to high end of current guidance. Having said that, I would like to pass the word to Richard. Thank you everyone for your attention.

Thank you, John. So as usual, I will start with an update on Cameras Markets and then progress to the progress with Brixadi in the US. So starting with Cameras Markets, in Q2, the positive long-term growth trajectory for Buvedal continued with sales of Buvedal during the quarter of 400 million sec, a 31% increase versus same period last year and 10% versus the previous quarter. Strong performances were seen across all our major markets, notably in the UK, where funding continues to reach clinics and the criminal justice settings as we anticipated. In Australia, we saw ordering patterns normalize after the recent changes in the reimbursement system, alongside continued growth of the long-acting buprenorphine segment, where we maintain a share of 80%. In Australia, we have year-on-year growth above 20%. In Germany, growth was also strong, notably in the community setting, as a result of strong sales force execution and new market initiatives. France continues to make headway in the specialist center setting, and the French government recently acknowledged the utility of long-acting injectable buprenorphine with the release of additional funding for the coming year. And finally, in Spain, where buprenorphine is growing well, we have high and growing penetration in the buprenorphine segment and seeing patient capture now from methadone. At the end of the quarter, we estimate we have well above 53,000 patients in treatment with Buvidal. We also continue to seek and to expand the geographical reach for Buvidal and have reimbursement applications expected to finalize in Key 3 and additional regulatory applications in progress. So now moving to the US. Considering the launch just nine months ago, the results for Q2 were impressive, with growing patient capture resulting in a continued positive picture for our royalty stream, with revenue for the quarter of 45 million sec, a 73% increase versus Q1. Braeburn have continued to execute on their plans. Support continues to improve. And remember, Brixardi payer coverage after six months was already aligned with other long-acting medications in OUD. Other leading indicators are positive, including continuing high interest in the medical education, high levels of filling of prescriptions in all channels, and the broad and expanding fully functioning distribution network. The positive dynamics on the execution is also resulting in a high patient and healthcare professional satisfaction rate. The high adoption of Brixadi alongside a significant unmet medical need and interest from patients and treatment providers has reinforced our positive view on the market potential for Brixadi in the US. During the quarter, we also continue to grow and share the growing evidence base for Buvidal and Brixardi. Key papers were published this quarter with two in JAMA Open Network. The first indicates that Buvidal may be favorable to sublingual buprenorphine in reducing fentanyl use, and the second from investigators at Yale University highlighted the potential of weekly Buvidal to initiate treatment for patients presenting in the emergency room setting, for instance, after an overdose event, and that facilitates the transition to longer-term treatment. In Q2, we've had significant presence at many of the scientific congresses across our markets with presentations on the experience in patients with multiple psychiatric comorbidities, healthcare professionals' positive perspective on the treatment of the long-acting buprenorphine, patient experiences from start of treatment with buprenorphine in France, and treatment dynamics in Australia confirming the utility of different doses and the importance of a product with individualized and flexible dosing. So on that point, I will hand back to Fredrik.