2/15/2024

speaker
Operator

Welcome to Comuros Q4 report 2023. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answer session, participants are able to ask questions by dialing pound key five on the telephone keypad. Now I will hand the conference over to CEO Fredrik Thibald. Please go ahead.

speaker
Fredrik Thibald
CEO

Thank you so much and good day, everyone. Thank you for joining our earnings call today. where we will report on the progress made by CAMRS during the fourth quarter and full year 2023. Please be aware of our forward-looking statements. The agenda for today's presentation is as follows. We'll start with a summary of the full year and Q4 highlights. Then we will move into financial results and the guidance for 2024, followed by commercial development and R&D pipeline updates. We'll finish off, as usual, with key takeaways and a Q&A. With me on the call today is John Garay, our CFO, and Richard Jameson, Chief Commercial Officer. So, 2023 has been a very successful and transformative year for cameras, with solid performance across the business. We continue to strengthen our leadership position in the treatment of opioid dependence across our markets. And we're pleased to see the US launch of Brigsadi gaining momentum with a strong uptake of patients in the fourth quarter. Our pipeline continued to advance with several important milestones achieved, including positive results from two phase three trials in the AcroInnova program. Following this, we submitted an MDA for Oclase in Acromegaly to the US FDA and are awaiting their acceptance letter. Aside from the operational progress, we delivered a strong financial performance in the year. This is reflected in a strong growth of both revenues and results in 2023, continuing the trend seen from the first Vuvida launch in 2019. We expect this positive development to continue during the coming years, as outlined in our five-year vision from 2022. In this slide, we have summarized the progress in the four pillars of our 2027 vision. Firstly, on the fivefold revenue increase target, we reached 1.7 billion SEK and are on track to deliver on our goal of 4.5 billion. Patients in treatment with Duvidal reached nearly 50,000 and Brixali was launched in the U.S. with expected peak sales beyond 1 billion U.S. dollars. We also progressed our work to establish an own commercial infrastructure in the U.S. As you may have seen in the press release earlier this week, Birshad Sheldon has been appointed president for our Camurus U.S. operations with responsibility for the launch of Oclays. thirdly we advanced the r d pipeline towards the goal of four new approvals firstly with the approval of excited in may and then the mda submission for oclays in december finally we also have an ambitious ambition to reach around 50 operating margin in 2027. we achieved 31 percent And going forward, we will continue focusing on our operational excellence and disciplined capital allocation. As you know, we additionally continued evaluating synergistic inorganic growth opportunities. To strengthen our transaction capability and flexibility, we recently raised 1.1 billion SEC in a directed share issue. So all in all, we are on track to deliver on our 2027 vision. And with this, I will leave over the world to John for a financial update.

speaker
John Garay
CFO

Thanks a lot, Frederick, and good afternoon, everyone. As Frederick mentioned, Camorus continued its growth journey during 2023. And now we will share with you the main highlights of our financial performance in the quarter and in the year. Camurus achieved 375 million SEK total revenue in the quarter, delivering a growth of 40% versus same period last year, with product sales of 366 million SEK, growing 37% versus prior year and 6% versus prior quarter. Additionally, Bricsaddy sales in the US represented an 8 million SEK royalty income in the quarter following its commercial launch on September last year. Looking at full year results, Camurus reached 1,717 million SEK total revenue, representing a growth of 80% versus prior year. This amount included 406 million SEK one-time milestone unlicensed revenues, mainly related to Bricsady approval in the U.S. Bricsavi Royalty represented 9.5 million SEK in 2023. Company achieved an EPS after dilution of 7.5 Swedish kronor, equivalent to a profit after tax of 431 million SEK during 2023. Finally, company cash position progressed positively during the year, ending at 1.2 billion SEK representing a 110% improvement versus prior year. If we now move to next slide, we can see the main components of our profit before taxes. Company gross margin reached 91.3% in the quarter, representing an improvement of 175 basic points versus same period prior year. The improvement was driven by three major factors. Supply chain efficiencies driven by VU with our volumes Scala represented 120 basic points. Secondly, 20 basic points are driven by Brixady Royalty. And thirdly, FX represented 35 basic points. On a full year basis, company gross margin reached 92.9%, with product gross margin at 90.7%, representing 146 basic points improvement versus prior year. Total OPEX reached 371 million SEC, representing a 67% increase versus same period prior year, driven by following factors. Marketing and distribution investment to support market penetration in own territories, expansion of Boobidal into new markets, and our recent U.S. operations grew 43%. Administrative expenses aligned with corporate evolution to substantiate company development grew 82% versus same period last year. R&D investment reached 230 million sec, growing 70% versus same period prior year, driven by recruitment completion in net, PLD progress, and AcroInnova last site closing and CSR finalization. Our OPECs were impacted in the quarter by a material 51 million SEK accrual related to social security costs of company long-term inceptive programs as a consequence of 73% share appreciation. Finally, Swedish Kronor appreciation in the quarter provoked an unrealized loss of 12 million SEK. On a full year basis, company profit before taxes reached 549 million SEK growing 476 million SEC versus prior year. If we move to next slide, company cash position at quarter end was 1.2 billion SEC. Camurus generated 36 million SEC cash in the quarter, driven by following factors. Firstly, company operations generated 38 million SEC, a proof of the strong operational performance in the quarter. secondly working capital increased by 8 million sec driven by sales growth and thirdly exercise of warrants program delivered 14 million sec cash finally other factors including translation required 8 million sec cash ascent of quarter camurus has no debt after the closing and in january Company raised 1.1 billion SEG via a directed share issue subscribed by a group of high quality international and local institutional investors. The subscription price was determined through an accelerated book building procedure. Let's now move to 2024 financial guidance. From a top line point of view, company has considered the following factors when providing 2024 revenue guidance. One-time milestone revenues of 406 million SEC in 2023, driven by BRICSAD's FDA approval and Camurus' regained rights to certain Asian territories for CAM 2038, will not repeat in 2024. Market conditions in current macroeconomic environment based on partner bank analysis include a negative FX impact of around 3% driven by anticipated Swedish kronor appreciation during 2024. As a consequence, we expect company revenues in the range of 1,740 to 1,860 million SEX equivalent to a growth excluding 2023 one-time master revenues of 33% to 42%. Importantly, we continue our double-digit business growth during 2024. From a bottom line point of view, company has considered continued investments to support the strategic vision 2027, including R&D will stay approximately flat versus 2023 in the level of 600 million SEC, incremental commercial investment of approximately 300 million SEG to establish our own U.S. operation, global launch preparations for CAM 2029 in Acromegaly, and commercial preparations for NET. Finally, social security costs regarding company long-term in-safety programs may temporarily fluctuate and could be material during the first half of 2024. As a consequence, we expect company profit before taxes in the range of 330 million SEC to 450 million SEC, equivalent to 131% to 215% growth versus 2023, excluding one-time milestone revenues. All in all, Camurus closes 2023 with a strong financial position, solid operational performance, interesting growth opportunities, and is on track to deliver the long-range plan vision. Having said that, I would like to pass the word to Richard. Thank you, everyone, for your attention.

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