Camurus Ab

good day everyone and thank you for taking the time to joining our second quarter earnings call today which i'm happy to note was our strongest quarter yet before starting the presentation please note our forward-looking statements here so the agenda for today's earning call includes a summary of second quarter highlights Then we'll go through the financial results, followed by commercial and pipeline updates. And as usual, then finish off with a Q&A. And with me on today's call is John Garay, our chief financial officer, Richard Jameson, chief commercial officer, and also Alberto Pedroncelli, our chief medical officer. The second quarter was really strong across the board for the company and transformative. We continued the commercial execution building on our leadership in opioid dependence treatment market with Buvidal. Net sales increased to 305 million SEK in the quarter, an increase of 36% against last year. In parallel, we continued market expansion with regulatory and market access processes and approvals. And on the pipeline development side, we achieved several major milestones in the form of the long-awaited FDA approval of Brasile in the US, and positive top-line phase three results for CAMP 2029 in Acromegaly, the ACRI NOVA 1 study. We reached two-thirds recruitment in our GetNet trial to Sorrento. And after the period, we announced positive phase three data from the second phase three trial of CAMP 2029, AcroInnova 2. On the corporate development side, we note record revenue and results. Six consecutive quarters now with positive operating results. We recognized the $35 million milestone for the approval of Bricsadi and got our US subsidiary, Cameras Inc., operational. So in summary, it was really an exceptional quarter for cameras where we delivered above our own expectations. And with that said, let's move over to the financial review. Please, John.

Thanks a lot, Fredrik. And good afternoon, everyone. We would like to share with you now the key highlights of our financial performance this quarter. In the second quarter, Camurus achieved 674 million SEG total revenues, delivering a growth of 197% versus same period last year, with product sales of 305 million SEG, growing 36% versus prior year, and 8% versus prior quarter. Bixadi approval by FDA triggered a one-off $35 million milestone revenue, which was recognized as income in the quarter. Operating result for the quarter was 376 million SEK, which means a 369 million SEK improvement versus the same period last year. Company has achieved an earning per share after dilution of 5.24 Swedish kronor equivalent to a profit after tax of 301 million SEC in the quarter. Finally, our cash position at quarter end was 654 million SEC, which is a 53% improvement versus same period prior year. In this slide, we can see the main components of our operating results. Gross margin reached 95.7% in the quarter, driven by $35 million milestone, approval of BRICSADY in the U.S. Excluding this one-off milestone, company gross margin reached 90.5% in the quarter, representing an improvement of 157 basic points versus same period prior year, driven by supply chain efficiencies as well as volumes scaled up. On a year-to-date basis, and excluding BRICSADY one-time Company gross margin was 90.2%, representing 167 basic points improvement versus the first six months of prior year. Total OPEX reached 270 million SEC, representing a 38% increase versus same period prior year, driven by following four factors. Marketing and distribution investment to support market penetration in owned territories and expansion of UBIDAN into new markets grew 32%. Administrative expenses aligned with corporate evolution to substantiate company development grew 38%. R&D investment reached 161 million SEG, our highest ever R&D investment growing 39% versus same period prior year, driven by progress in our ongoing three phase three trials, mainly AccroInnova One, Tom Blake results, readout, and recruitment progress in net. Finally, other OPECs were minus 3 million SEK driven by valuation of currency hedging contracts at quarter end. Company operating result became positive by 376 million SEK in the quarter. Excluding Brixadi 1 of Milestone, Camurus reached a positive 8 million SEK operating result with the highest ever investment in R&D. If we now move to next slide, Our cash position at quarter end was 654 million SEC, delivering a 53% growth versus same period prior year. Brick study milestone will be realized in cash in the third quarter. So, as it is neutral from cash flow point of view, in this quarter, we are excluding it in the waterfall we are showing for transparency purposes. Camurus generated 68 million SEC cash in the quarter, driven by following four factors. Firstly, company operations generated 38 million SEC. Secondly, working capital improved by 29 million SEC. Thirdly, exercise of warrants programs delivered 6 million SEC in cash. And finally, company invested 5 million SEC in technological activities. As end of quarter, Camurus has no debt. All in all, Camurus closes second quarter 2023 with a solid financial and operational position, having achieved the first two milestones of 2023 and continue showing interesting growth opportunities. Camurus reiterates its 2023 financial outlook, expecting total revenues and profit before taxes in the mid to high end of current guidance, and is on track to deliver the long-range plan vision shared at Capital Market Day celebrated in September last year. Having said that, I would like to pass the word to Richard. Thank you, everyone, for your attention.

Thank you, John. So I'll start with an update on Europe and Australia. We're pleased to share the continued positive momentum with Buvedal in Q2, built on the organic growth across our markets. As already mentioned by John, sales per quarter were 305 million sec, up 36% year-on-year, and 8% quarter-on-quarter. The estimated number of patients grew from about 39,000 patients to about 42,000, a net increase of 3,000 patients spread across our different markets. We saw continued good revenue growth in the Scandinavia, Finland, UK, Spain, and Australia, and in Australia, where the growth has offset the recent government price decrease. There was a positive trend shift also in Germany, which grew over 30% versus Q2 last year. We continue our market expansion and have four HTA and four regulatory submissions under review. And in Austria, we've received a new reimbursement status that allows improved patient access to treatment with Buvedal. Additionally, we saw continued strong momentum in the criminal justice system with new guidelines published in Sweden and Belgium recommending Buvedal as a first-line treatment in prisons and expanded use in this setting in the UK. And moving across to the US, As you already know, on the 23rd of May, we received the positive news that the FDA had approved Brixardi for the treatment of opioid use disorder in the U.S., with a positive statement from the FDA recognizing the expansion of dosing options to help patients sustain a long-term recovery. Brixardi is well differentiated in the long-acting injectable market and is expected to play a role in addressing the significant unmet needs of patients with OUD in the U.S., It's unique in having both weekly and monthly formulations and flexible dosing aligned with current practice and can be given through multiple injection sites. It's easy to switch to or from current daily buprenorphine treatments through a dose equivalence table. Rixardi is the only long-acting injectable that can be initiated from day one for those coming into treatment. And with small volume, small needle, and room temperature storage, it's simple to use and easy to store. So we're now looking forward to the upcoming launch in the U.S. of Bixardi. This is planned for September and will be conducted by our U.S. licensee, Braeburn. Braeburn has informed us they are well prepared with the commercial organization, including having a sales force in place. And from a market dynamics perspective, the launch is well-timed, as there's increasing funding becoming available for OUD treatment and new legislation introduced to expand patient access to treatment to help address the issue around the opioid crisis. Based on this positioning, we believe Bruxardi has the peak potential of above $1 billion. Cameras has a significant part of the financials, and we're looking forward to this successful commercialization by Vraburn. So on this note, I will hand back to Frederick for an update on the pipeline.