Camurus Ab

Good day, everyone. It's been a pleasure. It's a pleasure to have the opportunity to share our third quarter performance and results with you today. Certainly been a good quarter for cameras. Before starting the presentation, please note our forward looking statements. The agenda for the call today is a third quarter highlight overview, followed by financial results, commercial and pipeline updates, and then we will finish off with Q&A. In today's call, I'm joined by John Garay, our Chief Financial Officer, and Richard Jameson, our Chief Commercial Officer. As you may already have seen in this morning's report, CAMRS delivered a strong third quarter performance. resulting in very positive financial development with high double-digit revenue growth to 384 million SEK in the quarter and 1.3 billion SEK year-to-date. Our operating result was 104 million SEK in the quarter and 554 million SEK year-to-date, including also costs for three extensive phase three programs. Our cash position increased to 1.15 billion SEK, including a 35 million US dollar payment received from Braeburn. As a result of the strong financial performance in the quarter, we have recently raised our guidance for 2023. We continued our commercial execution in the opioid dependence area and saw bubidol sales grow by 44% year-on-year to $346 million set in the quarter. In the US, our licensee Braeburn launched Bricsadi for treatment of opioid use disorder, which was, of course, an important highlight. And this also resulted in the first royalty payments in the quarter. In addition, we had good progress in our R&D programs with positive top line phase three results in acromegaly, pre-NDA meetings with the US FDA, and accelerated recruitment in our large Sorento study. All in all, our teams delivered excellent performance in the quarter, and we are well positioned to deliver on our ambitious plans and strategy going forward. And with this, I'll leave over to John for a financial update.

Thanks a lot, Frederik, and good afternoon, everyone. We would like to share key highlights of our financial performance this quarter. Camulus achieved 384 million SEK total revenue in the quarter, delivering a growth of 59% versus same period last year, with product sales of 346 million SEK, growing 44% versus prior year, and 13% versus prior quarter. Additionally, in product sales, Camurius recognized 25 million SEC revenue related to the expiration of Breborn's option period for Buvidal in China, Japan, Korea, and Taiwan. And by first time, Bricsaddy sales in the U.S. represented a 1 million SEC royalty income following its commercial launch on September the 5th. Company achieved an earning per share after dilution of 1.5 Swedish kronor, equivalent to a profit after tax of 86 million SEK in the quarter. Finally, company cash position at quarter end was 1.15 billion SEK, representing a 122% improvement versus same period prior year. If we now move to next slide, we can see the main components of our operating result. Company gross margin reached 91.7% in the quarter, with product sales gross margin at 90.8%, representing an improvement of 80 basic points versus same period prior year, which is driven by supply chain efficiencies as volume is scaled up. On a year-to-day basis, product gross margin was 90.4%, representing 135 basic points improvement versus the first nine months of prior year. Total OPEX reached 253 million SEG, representing a 37% increase versus same period prior year, driven by following three factors. Marketing and distribution investment to support market penetration in owned territories and expansion of bubidal into new markets grew 41%, Administrative expenses aligned with corporate evolution to substantiate company development were flat versus same period last year, and R&D investment reached 148 million SEG, growing 39% versus same period prior year, driven, on one hand, by progress in our ongoing three phase three trials, mainly recruitment progress in NET and PLD, and on the other hand, breakout of AcroInnova 2 top-line results. Company operating result as a consequence became positive by 104 million SEC in the quarter. If we now move to next slide, company cash position at quarter end was 1.15 billion SEC. TAMURUS generated half a billion SEC cash in the quarter driven by following three factors. Firstly, company operations generated 121 million SEC. Secondly, working capital improvement drove 365 million SEC, driven by collection of Rizadi milestone following FDA approval in Q2. And thirdly, exercise of warrants program delivered 17 million SEC cash. As end of quarter, Camurus has no debt. All in all, Camurus closed third quarter with a strong financial position, solid operational performance, and interesting growth opportunities. As a consequence of such a strong performance year to date and due for expectations, Camurro's guidance for total revenue was increased to the range of 1,640 to 1,720 million SEK from prior range of 1,530 to 1,650 million SEK. With profit before taxes estimated in the updated range of 525 to 600 million SEK, from prior range of 425 to 525 million SEK, and company 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 will give a brief update on the strong progress in cameras markets and an update for the US following the first three weeks of the launch of Brixadi. So if we start with the cameras markets, Q3 was another strong quarter for our teams in Europe, Australia and the MENA region. Our net sales reached for 346 million sec, which is 44% up against the same period last year and 13% ahead of Q2. We had underlying strong in-market performance with additional positive contributions from current exchange rates and also some stocking from distributor markets. We now have an estimated 45,000 patients being treated with Buvidal in the quarter. We saw good growth across our markets, notably UK, Nordics, Germany, Austria and Spain, and highlights include further acceleration in the UK, as recent funding from government reached treatment clinics. 6% of the patients across the UK are now in treatment with Buvidal. And additionally, the UK Health Select Committee, who review the progress on the government's drug strategy, reinforced the value that long-acting buprenorphine can bring to patients. In Germany, we saw good expansion into the prison setting with five new prisons initiating treatment with Buvidal in the quarter. And in Australia, we maintain our leadership position in the long-acting Brupenorphine segment and continue to see growing patients on Buvidal. There has also been structural changes in the treatment system in Australia, with one positive result being a reduction in the co-pay for many patients, and this has the potential to see more patients enter treatment. Bouverdard was also launched in Italy in Q3 by Montaigne, our distribution partner, who have wide experience in the addiction space with a space with an already established commercial team. We continue to expand into other markets and have four regulatory and four pricing submissions under review, and other markets are under assessment. Now moving to the U.S. As already mentioned, Brixardi was launched into the U.S. market in September by our licensee Braeburn. and already progress has been made and leading indicators are positive. Braeburn have a sizeable and focused commercial team in field at launch with more than 100 people across sales, marketing, market access, and alongside the medical affairs team. All 50 states have access to Buvedal as of the beginning of October with good prospects for obtaining unrestricted access with both Medicaid and private payers. I'd already mentioned in Q3 we received our first royalty payment of 1.2 million SEC for the first three weeks of sales. And to remind you, the market opportunity in the US is significant with an estimated 6 million people suffering from opioid use disorder, of which 1.8 million are in treatment. The market dynamics are positive with increasing funding, improved and improved legislation to make treatment more accessible to patients. Brixardi has a unique position in the U.S. market. It's the only product with weekly and monthly formulations, has flexible dosing aligned to clinical protocols, and an indication for initiation of treatment after a single test dose of sublingual buprenorphine. Additionally, the product attributes of low-volume injections, small needle, multiple sites for injection, and root temperature storage are other advantages. So in summary, with a strong product profile and a sizable commercial team in place, the prospects for a successful launch are good. And on that, I'll hand back to Fredrik.