Camurus Ab

Thank you so much and good day, everyone. Thank you for taking the time to join our first quarter earnings call today. I'm pleased to report on a strong quarter. But first, before starting, please note our forward-looking statements. We will begin today's call with a summary of first quarter highlights, then go to financial results, followed by commercial and R&D pipeline updates, and finish off with Q&A. With me on today's call, as previously, is John Garay, our Chief Financial Officer, and Richard Jameson, our Chief Commercial Officer. So, let me first start with the first quarter highlights. We had an excellent start of the year with good top and bottom line growth. Bipedal net sales grew by 40% year-on-year to 282 million SEK. We received new markets and pricing approvals in the Middle East and Europe. And in the U.S., the FDA review of BRICSIDY-NDA continued, with the PDUFA date coming up in just two weeks' time. In the R&D pipeline, four Phase III trials and one Phase IIb trial progressed in different indications, where, importantly, the pivotal Phase III trial of CAMP2029 in Acromegaly is now being completed. In the Sorento trial, that is clinically, I should say, in the Sorento trial, we reached 50% randomization out of a target of 302 GetNet patients. And then we can also mention that our partner, Rhythm, completed the enrollment in their phase three trial of weekly set melanotide for treatment of genetic obesity disease. On the corporate side, we delivered profitability for the fourth consecutive quarter, in this case of 59 million SEC, an increase of 60 million versus Q1 2022. And we strengthened our cash flow. We continued growing the company with new talent, including appointing Alberto Padroncelli, MD, PhD, as our new chief medical officer and member of the executive management team. And we started the build-up of our US commercial infrastructure for CAM 2029. So with this brief introduction, I'll hand over to John for a financial update.

Thanks a lot, Frederick, and good afternoon, everyone. We would like to share with you now the main highlights of our financial performance this quarter. From a total revenue point of view, Camurus achieved 284 million SEK in the quarter, delivering a growth of 29% versus same period last year and with product sales of 282 million SEK growing 40% versus prior year and 6% versus prior quarter. Product sales grew materially higher than our total revenue as Q1 last year recognized all the revenues by an amount of 18 million SEK including milestone by Riden Pharmaceuticals. Operating result for the quarter was 74 million SEK which means a 69 million SEK improvement versus same period last year. Company has achieved an earning per share after dilution in the quarter of 1.02 Swedish kronor, equivalent to a profit after tax of 59 million SEK in the quarter. And finally, Camoru's cash position at quarter end was 586 million SEK, which represents a 47% improvement versus same period prior year. If we now move to next slide, we can see the main components of our operating result. Gross margin improved 175 basic points in the quarter, driven by production efficiencies reducing scrap by 139 basic points, and FX favorability driving 36 basic points. In total, gross margin delivered 255 million sec in the quarter, and year-to-date gross margin reached 89.9%. Total OPEX reached 184 million SEC, which is a 3% decrease versus same period prior year, driven by following four factors. Firstly, marketing and distribution investment to support market penetration in own territories and expansion of Gubidal into new markets grew by 32%. Secondly, administrative expenses aligned with corporate evolution to substantiate company development grew by 37%. Thirdly, R&D investment declined 15% versus same period prior year, driven by timing of milestones in our three ongoing phase three studies and clinical trial product generation. And finally, gain for hedging contracts was positive by 3 million sec in the quarter, while prior year same quarter was negative by 9 million sec. Company operating result became positive by 74 million SEC in the quarter. Profitability may fluctuate between quarters as we continue our investment in our pipeline to bring product candidates to market as soon as possible. If we now move to the next slide, our cash position at quarter end was 586 million SEC, delivering a 47% growth versus same period prior year. Camurus generated 80 million SEC cash in the quarter, mainly driven by company operations, generating 86 million SEC, compensated by 61 million SEC investment in working capital, mainly customer receivables following sales growth. Other small drivers drove 4 million SEC cash reduction, mainly these liabilities. As end of quarter, Camurus has no debt. Our guiding principles for capital allocation continue being Reinvest in our business to accelerate booby-doll market penetration and geographical expansion. Secondly, bring Can2029 to market as planned. And lastly, support our company's strategy in the area of organic growth opportunities, enhancing our company value. All in all, Camurus closes first quarter with a solid financial position, interesting growth opportunities, and is on track to deliver 2023 market guidance. Having said that, I would like to pass the word to Richard. Thank you, everyone, for your attention.

Thank you, John. Good afternoon, everybody. So we'll move to a commercial update, and I'll start in Europe, with Bufordale's progress in Australia, Europe, and MENA. Bufordale continued to grow, and sales for the quarter were 282 million sec, up 40% year-on-year, and 6% quarter-on-quarter. And this increase comes on the back of a strong Q4 where we had large one-time orders from the MENA region following the pricing and reimbursement approvals. We saw good growth across markets, most notably in the UK, where Buvidal exceeded 5% total patient share as new funding became available and was allocated to the treatment clinics. Similarly, the interest of using Buvidal in criminal justice settings is increasing in several countries and still constitutes a substantial opportunity for further growth. Based on the in-market sales in March, we had about 39,000 patients in treatment at the end of the quarter, a net increase of 3,000 patients since December. Our market expansion efforts also continued during the quarter, resulting in market approval in the UAE and pricing approvals in both UAE and Greece. In addition, we have four regulatory applications and four pricing submissions under review. Finally, as presented earlier, we withdrew our variation application for Buvedal in chronic pain and we'll come back to this development after the summer. So now moving over to the US. The US approval decision for Brixardi is imminent with a PDUFA date in less than two weeks. We see a significant market opportunity for Brixardi in the US and based on the large medical need and the treatment gap shown on the right-hand side of the slide, There are new government initiatives to increase access to treatment, it's a growing market, and there's a clear differentiation and positioning of Brixadi. So if we take each of those in turn, because of the severity of the opioid crisis, several important measures were recently taken by the US government to lower the bar to treatment. These include an increase in funding with over $6 billion, removal of data waivers so physicians can treat more patients, and new guidance to support expansion of treatment in the criminal justice setting. The U.S. opioid use disorder market is expected to grow significantly in the coming years to over 3.5 billion U.S. dollars. Long-acting injectable buprenorphine is forecasted to be a major growth driver of this expansion. And currently, only an estimated 3% to 5% of patients receive long-acting injectable treatment. In addition to these positive market dynamics, Brixadi and, of course, Buvidal in Canberra's rest of the world markets is well differentiated with flexible dosing and pathology, both weekly and the monthly formulations. It's easy to switch from current daily treatments through dose equivalent table. It's the only long-acting injectable that can be initiated from day one, and it's simple to use and easy to store. With all these factors, we look forward to seeing Braeburn successfully launch Bixadi in the US and making it available to patients. On that, I'll hand back to Frederick.