7/15/2022

speaker
Fredrik Thyberg
Chief Executive Officer

Thank you so much and hello everybody. Thank you for taking the time to joining us this Friday afternoon for our second quarter earnings call. It's a pleasure to update you on the continued progress of cameras. Please note our forward-looking statements. And this is today's Agenda. With me on the call is John Garay, our chief financial officer, and on the phone from Cambridge, UK, is Richard Jameson, our chief commercial officer. Before going to highlights, here is a snapshot of cameras three years after the approval and launch of our first transformative medicine, Bovidal. We have Canfar. proven our commercial execution ability and emerged as a leader in the opioid dependence treatment field, advanced our late-stage pipeline of innovative, long-acting treatments targeting high unmet needs, CNS, and rare disease areas with potential blockbuster status, and are showing strong revenue growth towards our goal of sustained profitability. with further potential upside in our late stage pipeline and partner programs. In the second quarter, following a solid first quarter, we entered profitability for the first time as a publicly listed company. We continued to deliver high double-digit year-on-year revenue growth, reinforced our cash position and financial flexibility, and raised our guidance for full year 2022 results, from loss to profit at the interval midpoint. We continued commercial execution, resulting in increased patient shares and expanded markets, and strengthened our leadership in the opioid dependence area. On the R&D side, we progressed our pipeline, including variation applications for Buvidal in EU and Australia, to extend the indication to include chronic pain. Phase 3 programs of CAM-2029 in acromegaly and neuroendocrine tumors were further progressed, and we started a clinical phase 2b study of CAM-2029 in a third indication, polycystic liver disease. We also caught up on the operational clinical study milestones from the previous period. Overall, it was a productive, successful quarter, thanks to our great teams and collaborations. With these introductory words, I hand over to John for a review of our financial performance in the period.

speaker
John Garay
Chief Financial Officer

Thanks a lot, Fredrik, and good afternoon, everyone. Hope you are doing well. We would like to share with you now the main highlights of our financial performance this quarter. From a total revenue point of view, Camurius achieved 227 million SEC in the quarter, delivering a growth of 64% versus same period last year, with product sales of 225 million SEC growing at 65% versus prior year and 11% versus prior quarter. Operating results for the quarter was positive and reached 7 million SEC meaning a 67-million-sec improvement versus second quarter last year. And the trend, as displayed by the chart, shows our commitment to profitability. As Fredrik has mentioned, this quarter settles the historical milestone for Camulus as it was the first profitable quarter for the company delivering a positive earning per share of 0.5 kroner, equivalent to a profit after tax of 8 million SEK. On a year-to-day basis, company review was 447 million SEK, growing 69% versus prior year, delivering a 12 million SEK positive operating result. Our cash position at quarter end was 428 million SEK, which is a 1% growth versus same period prior year. As you may have seen in our cash flow statement published this morning, our cash flow from operations, including working capital change, has been positive by 10 million SEK. And as a faint of quarter, Camoros has no debt. If we move now to the next slide, we can see the main components of our operating result once revenue has already been covered. Gross margin reached 202 million SEC, improving 388 basic points as reported versus same period prior year and delivering an 88.5% year-to-date. Total OPEX reached 196 million SEC, a 10% increase versus same period prior year driven by following three factors. Sales and marketing investment to support market penetration in our own territories and expansion of Boobies and into new markets. Secondly, corporate functions development. And firstly, catch up in our operational R&D milestones from prior quarter this year. As a result, our operating results became positive by 7 million SEC in the quarter and 12 million SEC year 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 take a couple of quarters to see our profitability stabilizing. At this point, Frederic and I would like to communicate you all an improvement in our operating result 22 full year guidance and raise it by approximately 35 million seconds. from initial guidance range of minus 60 million sec to plus 10 million sec to an improved range of minus 20 million sec to plus 40 million sec with no change in top line guidance. Thanks a lot everyone for your attention. And now I would like to pass the word to Richard.

speaker
Richard Jameson
Chief Commercial Officer

Thank you, John. Hello everyone. I will start with the continued progress with Boverdale. In Q2, we achieved the 12 consecutive double digit quarter on quarter growth, reaching 225 million sec, a growth of 65% over the same quarter last year. We've estimated we are close to now having 30,000 patients in treatment at the end of Q2. We achieved this through continuing to build our market leadership in the Nordics, for example, where we had strong growth across all the markets. In the UK, we had positive market share development in Wales and Scotland. And importantly, as we see the impact of new government funding becoming available, we've seen strong acceleration in England, which has grown more than 100% in the first half of this year versus the second half of last year. 60% of the municipalities in England now have patient access to Boobadal. In Australia, we're maintaining our leadership in the long-acting buprenorphine segment and improved our label for Buvidal with reimbursement of 160mg dose and direct initiation onto Buvidal, which is unique for the long-acting buprenorphine products. Furthermore, we improved access in our future growth markets, including Spain and France and the MENA region. As a notable example, in Spain, over 90% of eligible patients live in a region that now has access to Buvidal. We're also expanding access in all treatment segments, including criminal justice settings across all of the markets. So going forward, we will continue to focus on the commercial execution on our markets to accelerate patient access and uptake. For markets where we have full access, we focus on facilitating patient uptake through medical education and informed choice, ensuring Buvedal is offered as a first line treatment option. In countries where there is some restriction on access, we're addressing the barriers through communicating the compelling value proposition and addressing funding. And finally, we're planning launches in those markets where we're awaiting the pricing and reimbursement approvals, having submitted dossiers that clearly demonstrate the value Buvedal brings to health economies, physicians, and of course, patients. We remain on track to realize our goal of having 100,000 patients on Buvedal by the end of 2026. As we build our business, there's also a significant additional upside in the outcomes of ongoing regulatory and market expansion processes. In the US, the news from Braeburn is that the FDA has initiated inspections of Braeburn's third-party manufacturer. Depending on the outcome, Braeburn will resubmit the Brexadi NDA as soon as practicable, with a two- or six-month review period to a new PDUFA date. And with the history of the past, we see this as positive news for Buber now. In addition, we're progressing the market authorization applications in seven additional countries in MENA region with the expectations of approval decisions in Q3 and the coming quarters. And for chronic pain, we've made variation applications in Europe and Australia. And according to the procedure, we're preparing responses to CHMP requests for supplementary information. And we anticipate a CHMP opinion in Q4 this year and a TGA approval decision in the first half of next year. We also have had high visibility and a significant presence at scientific conferences with a number of presentations in Q2 at both international and national level. They've included many presentations on physician and patient experience with Buvidal and the positive impact this innovation is having on those suffering with opioid dependence. Our medical affairs team will continue this high-level activity with presence at the up-and-coming conferences and through building our robust clinical data, the real-world experience and evidence with Buberdar. Key congresses in H2 include ISAM, the International Society of Addiction, meeting in Malta in October, and Lisbon Addictions, the European Conference on Addictive Behaviours and Dependencies in November. So that completes the commercial update on a strong quarter, and I now hand back to Fredrik.

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