Camurus Ab

Thank you so much. Good day everyone and thank you very much for taking the time to joining our results call today. Before starting the presentation, please note our forward looking statements. So here is the agenda for our earnings call today. We will start with the first quarter highlights, followed by a financial update by John Garay, our new CFO. Then Richard, our chief commercial officer, We'll give a commercial overview before we move over to the pipeline and an update on our late stage R&D programs. As usual, we will finish off with some key takeaways followed by Q&A. As you may have seen already in the report today, cameras had a really good start of the year with strong performances across company functions. Notably, we achieved an important financial milestone in the reporting of positive operational results in the quarter. This was driven by continued strong top line growth and an effective use of operational and R&D resources. Consequently, we maintained our stable cash position and are on track to reach profitability during the second half of the year. This while also investing approximately half a billion SEC in the development of our promising late-stage pipeline. On the commercial side, we continue to execute according to plan and are achieving high double-digit year-on-year sales growth. We strengthened our leadership in established markets in EU and Australia, accelerated sales of Bovidal in important growth markets, and improved market access through new approvals and funding streams. On the R&D side, we submitted a variation application for buvidal in chronic pain in Australia, which is now under review alongside a corresponding application in the EU. Our phase 3 programs of CAMP 2029 in acromegaly and neuroendocrine tumors continue to progress. And we completed preparations for the start of a clinical phase 2b study in a third indication polycystic liver disease. Finally, we achieved a phase 3 milestone in the partnership with Rhythm Pharmaceuticals. So with these positive highlights, I will hand over to John for a financial update.

Thanks a lot, Fredrik. Good afternoon, everyone, and wish you are all doing well. Our Q1 interim report has been published this morning and we would like to share with you now the main highlights of our financial performance in Q1 2022. From a total revenue point of view, we achieved 220.3 million SEK in Q1, delivering a growth of 75% versus same period last year. Our total revenue this quarter is made up of product sales, 202 million SEK, growing at 63% versus prior year, which means a growth of 56% at constant exchange rates. Order revenue was 18 million SEK in the quarter, including 9 million Swedish kronor milestone received from Riden Pharmaceuticals. Overall, compared to Q1 2021, our total revenue grew by 21%. Our operating result for the quarter was positive and reached 4.8 million Swedish kronor. This means a 31 million kronor improvement versus Q1 2021. And the trend displayed by the chart shows our commitment to profitability. As Frederik mentioned earlier, it is the first quarter we have achieved a positive result since the listing of our company. Our cash position at quarter end was 400 million Swedish kronor, which is a 7% reduction versus Q1 prior year. As you may have seen in our cash flow statement published this morning, our cash flow from operations before working capital has been positive by 21.5 million Swedish kronor, while working capital has increased in the amount of 29 million kronor. Accounts receivables and inventory explain that increase in working capital, which is driven by our company growth. If we now move to the next slide, we can see the main components of our operating result and its evolution, both as reported and at constant rates. Our gross margin improved by 59 basic points as reported versus the same period prior year. Our marketing and distribution expenses grew 28%, to support market penetration and expansion of bubidal in owned territories. R&D expenses increased by 42%, mainly driven by continued progress in the three ongoing Phase III studies of CAMP 2029 for the treatment of acromegaly, neuroendocrine tumors, and polycystic liver disease. The decline shown in general and administrative expenses is mainly driven by the high legal expenses in 2021 Our operating result became positive by 5 million Swedish kronor thanks to priorly explained profitable growth plus a delay in the CAM 2029 R&D milestone cost that will be achieved later this year. As we continue investing in our pipeline, it will take a few more quarters to see our profitability stabilizing. Finally, we maintain our full year guidance for 2022 as communicated by mid-February. No change at the moment. Please remember our guidance does not take account of potential $35 million development milestone on US approval of BRICSAD. Thanks a lot for your attention today. And I would like now pass the word to Richard, who will take us through the commercial update. Thank you, John.

Good afternoon, everyone. So in Q1, we continue to make good progress with Buvidal, with sales above 200 million sec for the quarter, 63% up on the same period last year, and 12% above a strong Q4 2021. We now estimate we have more than 27,000 patients in treatment, with an additional net 2,000 patients starting treatment in the quarter. The Nordics and Australia continue to be high performers. In both markets, we've had excellent penetration and gained significant share. In the Nordics, we now have an estimated 50% of the buprenorphine patients and overall more than 20% of all patients in treatment are now on buprenorphine. In Australia, we have 35% of the buprenorphine segment and 80% share of the long-acting treatments and a similar penetration to the Nordics of 20% of all patients in treatment. Alongside these successes, we've also seen good momentum in other future growth markets with growth above 15% versus previous quarter in UK, Germany and in France. We're also establishing the utility of Buvidal across treatment settings with continued growth in community treatment and further success in criminal justice settings, including a first line recommendation in Australia. So we maintain our positive outlook for Buvedal as we continue to work across markets, addressing the hurdles to ensure patient access and the patient receive an informed choice of treatment options. Following the significant progress in Scotland and Wales, England is now accelerating as the government funding and focus to build a world-class treatment system begins to take effect. The 2022 allocation of the 780 million funding announced earlier has now been allocated to the top 50 regions with the highest unmet need. Novel, long-acting opioid medication is now on the menu of options in the indicative planning material that commissioners should consider when assessing where to make an investment. In France and Spain, we continue to work on accessing funds and made significant progress. In Spain, 88% of patients in treatment now live in a region where access to Buvidal is now approved. In France, we've initiated treatment in both criminal justice and community settings with very positive feedback. Furthermore, the importance of continuity of care and access to innovative treatments in opioid dependence led to the publishing of a public interest article in Le Monde, the leading national newspaper. The article was co-signed by both physicians and members of parliament calling for funding for innovative treatments such as long-acting buprenorphine. In Germany we also had a strong Q1 as we've seen some promising market development as experience and awareness of Buberdao grows. We also continue our work to expand into new geographies with ongoing pricing and reimbursement processes with expected outcomes in a number of countries allowing us for additional launches in the next two quarters. We're also planning launches in large MENA markets in 2022 and three of those and have other regulatory submissions underway in the region. Our progress is aligned with our long-term goal that more than 100,000 patients will be in treatment with Buvidal by 2026. We continued, as I said, to make progress on the regulatory side with Buvidal. In the quarter, we received market approval in the Lebanon, adding to early approvals in Europe, Australia, UK, Switzerland, New Zealand and Israel. We are progressing market authorisation applications in five additional countries in the Middle East, including two new submissions made during Q1. In the US, following the issuing of the CRL to Braeburn in December, Braeburn have been working on the remediation plan and we expect clarity on the Brixardi NDA resubmission timeline in Q2 2022. So on that, I'll hand back to Frederick.