Camurus Ab

Hello, everyone, and welcome to our third quarter earnings call. I'm pleased to present another productive and financially strong quarter for Camerus. Before starting the presentation, please note our forward-looking statements. So here is today's agenda, which includes a short introduction with third quarter highlights, followed by financial, commercial, and R&D updates. With me on today's call is our CFO, John Garay, and our Chief Commercial Officer, Richard Jameson. As I mentioned, we had a good third quarter. Financially, it was our best to date, where we delivered positive operation results for the third quarter in a row. And strong cash flow contribution of 90 million SEC. Based on the development, we raised our guidance for full-year operations result by 45 million SEC in the interval midpoint. Privadol continued to gain market share. We reinforced our leadership position in the opioid dependence market in Europe and Australia and continued our market expansion efforts with new regulatory and pricing approvals. On the R&D side, we continued to progress our late-stage pipeline programs including variation applications to expand the indication for Bovidal to include chronic pain. We reached a significant milestone of finalizing recruitment in our ongoing phase 3 trial in acromegaly, and we also started dosing of patients in a phase 2b study in polycystic liver disease. Finally, we held our capital markets and R&D day in Stockholm, and presented our five-year vision for growth and innovation for cameras. And here I want to thank you, everybody who participated in this meeting and made it such a great event. So with this very brief introduction, I'll hand over to John for a financial update.

Thanks a lot, Fredrik, 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 241 million SEK in the quarter, delivering a growth of 57% versus same period last year and with product sales of 241 million SEK growing at 58% versus prior year and 7% versus prior quarter. Operating result for the quarter was positive and reached 41 million SEK meaning a 48 million SEK improvement versus third quarter last year. And the trend, displayed by the chart, shows our commitment to profitability. Company achieved an earning per share in the quarter before dilution of 0.63 kronor, equivalent to a profit-added tax of 35 million SEK in the quarter. On a year-to-date basis, company revenue was 688 million SEK growing 65% versus prior year, delivering a 53 million sec operating result and a 42 million sec positive profit after taxes. If we now move to next slide, we can see the main components of our operating result this quarter once revenue has already been covered. Gross margin reached 217 million sec, improving 360 basic points versus same period prior year. and delivering at 89.1% year-to-date. Three factors explain our gross margin improvement. Firstly, 200 basic points driven by efficiencies in our manufacturing and supply chain operations. Secondly, 85 basic points driven by better country and price mix. And finally, 79 basic points driven by FX. On the OPEC side, company reached 184 million SEC which is a 32% increase versus same period prior year, driven by following three factors. Firstly, marketing and distribution investment to support our market penetration in own territories and expansion of Boobidal into new markets. Secondly, administrative expenses driven by corporate functions development. And thirdly, R&D progress in the three indications of our CAN 2029 programme. Company operating results became positive by 41 million SEK in the quarter and 53 million SEK GR to date, mainly driven by sales growth and gross margin improvement. As we continue our investment in our pipeline to bring product candidates to market, it may still take a couple of quarters to see our profitability stabilizing. At this point, Frederick and I want to communicate to you all an improvement in our operating result full GR guidance. from revised guidance range of minus 20 million SEK to plus 40 million SEK to an improved range of plus 40 million SEK to plus 70 million SEK. If we now move to next slide, our cash position at quarter end was 520 million SEK, delivering a 22% growth versus same period prior year. Camurus generated 90 million SEK cash in the quarter, mainly driven by strong operations, generating 55 million SEK cash, and warrant program exercised by our employees, generating 37 million SEK. As you may see in the graph, our business growth has almost required no investment in working capital. And as end of quarter, Camurus has no debt. Our guiding principles for capital allocation continue being, firstly, reinvest in our business with two clear objectives. On one hand, to accelerate booby-dung market penetration and geographical expansion, and on the other hand, bring CAN 2029 program to market as planned. And our second guiding principle is to support our company strategy in the area of synergistic M&A opportunities, enhancing our company value. Thanks a lot, everyone, for your attention. And now I would like to pass the word to Richard.

Thank you, John. As already mentioned, Boverdale sales grew 58% year on year and 7% versus the previous quarter. As expected, growth was impacted by the vacation period in some markets in Europe, with fewer patients initiating treatment, but then picked up again in September. Notable growth was seen in the UK, where a new funding started to become available after the government's decision to invest in improving the treatment system. In numbers, we passed the milestone of having sold more than 1 million Buvedal units since launch and now have more than 32,000 patients in treatment at the end of the quarter. Our market expansion success continued with new regulatory approvals in Egypt and Saudi Arabia, where Buvedal became the first approved maintenance treatment for opioid dependence. and launches are planned in Q4 in those markets. We also expanded our reimbursement in Belgium, taking away hurdles and opening up for distribution by our community pharmacies, and announcing a very high interest among prescribers in that country. In addition to granted approvals, we have five additional regulatory applications under review with expected approvals in 2023. We remain committed to share the growing evidence for treatment with Buvedal at international meetings and congresses, And as you can see, our medical teams are very active across our geographies. In addition, we see continued flow of publications describing use and treatment outcomes with Buvidal, and we have several new publications underway. Moving to the next slide and an update on information about the market expansion process in the US, where our latest news from Rayburn is that The FDA inspections of Braeburn's third-party manufacturer are about to be completed after various interruptions, including COVID and other external factors. We're now waiting for information about the inspection outcomes and time for resubmission of the Bruxardi NDA to the FDA. As we've mentioned previously, the nominal time for resubmission to approval is two or six months, depending on the FDA's classification. In waiting for the treatment to come available in the U.S., we are pleased that more than 2,000 patients have or will receive Brixardi in ongoing investigator-initiated trials, generating more experience and building the evidence base across the clinical settings in the US. On that brief update, I'll hand back to Fredrik for the R&D.