Camurus AB (publ) (CAMX) Earnings Call Transcript & Summary

[Audio Gap] In-market sales were up 19% versus the same period last year and 6% quarter-on-quarter, which reflects strong underlying demand. Growth was broad-based across geographies, including the Nordics, Germany, Spain and France, and U.K. saw improving sales as new NHS funding starts to become available. Australia was steady with prescribing capacity in parts of the market, a limiting factor that we're addressing with clinics and providers. Ubeda remains the clear leader there with over 80% of the LA IB segment and an overall market share of patients above 30%. In Australia, at the end of the quarter, it was announced that the other long-acting buprenorphine product is being withdrawn from the market by the end of 2026. The product has a minority share of the long-acting injectable buprenorphine segment and our priority in this regard will be to ensure continuity of care for patients working with clinics as we've done similar transitions in Sweden, Finland and Germany. We ended the quarter with an estimated 77,000 patients in treatment, up a net 4,000 and we're on track towards the 100,000 patient ambition by the end of 2027. [Audio Gap]

Clearly, the ACRINova-3 program is completed, and it's being communicated at various medical conferences and elsewhere. [Audio Gap] Oxia is approved in the U.K. and EU and the European launch is underway. In the U.S., the FDA issued a complete response letter for Atlas in June. Importantly, this relates to observations during a previous GMP manufacturing inspection at a third-party site and not to the efficacy or safety or otherwise for CAM2029. Those observations have now been addressed and new PDUFA target action date is the next important regulatory milestone for the program. Our view of the clinical profile and commercial opportunity for CAM2029 remains unchanged. Our largest near-term opportunity, though is gastroenteropancreatic neuroendocrine tumors, a substantial and growing market with considerable unmet medical needs. Sorento is the largest randomized study of somatostatin receptor ligand in Gap net to date and is our most important pipeline catalysts this year. The study has been fully enrolled since the end of 2023. And based on current event accrual, we expect to reach the target of 194 progression-free survival events in the fourth quarter followed by the readout of primary results. A positive outcome for CAM2029 that would support the compound as a new first-line treatment option opening a very meaningful new growth avenue for cameras. Finally, in polycystic liver disease, the positive Positano Phase II results were presented and recognized at this year EASL conference in Barcelona, a leading hepatology event. We hold orphan drug designations in the U.S. and EU for PLD and ADPKD and have completed the FDA end of Phase II meeting this year, and the extension study is currently ongoing, which together with the feedback will form the basis for the decision around the continued Phase III program. Beyond CAM2029, our earlier-stage pipeline gives us additional exposure to large therapeutic areas while allowing us to leverage the same long-acting delivery experience that underpins our commercial portfolio. CAM2056 is our once-monthly semaglutide depot based on the fluid crystal technology. During the quarter, we completed a Type B meeting with the FDA and the regulatory submission package for the Phase IIb clinical trial has been prepared. The study remains on track to start in the second half of the year, building on the positive Phase Ib data reported in November. Product design work is also ongoing in parallel, including the validation of auto-injector pen to support simple once-monthly dosing. We see a meaningful opportunity for once monthly incretin therapies overall, particularly given the adherence challenge seen for current weekly and daily treatments. Our collaboration with Eli Lilly is progressing to plan. During the quarter, Lilly exercised its option to include amylin agonists and expanding the scope of the partnerships beyond the dual and triple incretin agonist that we had already started. We view this as a further external validation of the fluid costal technology and its potential in the long-acting metabolic medicine space. With Gubra, we have selected the lead compound for our long-acting parathyroid hormone and analog program and are advancing into further development. Taken together, these programs provide several independent opportunities to create value across large and underserved therapeutic areas, supported by our own development capabilities and 2 well-resourced partners. Let me close with some brief quarterly summary and priorities ahead. Our strategy rests on four clear priorities: first, commercial execution, extending our leadership in the opioid dependence area with Burra and Brixadi and advancing the Oxia launch in Europe strengthening the revenues and broadening the CAM2029 commercial efforts. Second, advancing our pipeline with multiple near-term catalysts, with a rental readout in GAAP net the start of the CAM2056 Phase IIb and the U.S. resubmission pathway for Okla, alongside progress in the broader portfolio. Third, partnerships and business development. We are progressing our collaborations with Lilly and Gubra and we remain active in evaluating opportunities that can broaden our pipeline and add long-term value for the company. And fourth, financial strength, we have been sustainably profitable since 2022 and ended the quarter with SEK 4.1 billion in net cash giving us the means to invest behind our launches, pipeline, business development opportunities while maintaining strategic flexibility. The second quarter showed our model is working with record product sales, strong profitability, disciplined investment and a robust balance sheet. We now enter a catalyst rich second half with clear priorities, commercial execution, pipeline advancement and selective capital deployment. With strong momentum across the business, we are well positioned to continue creating value for patients and, of course, also for shareholders. Ana, with that said, we are ready for the first question.

Thanks, Kenric. The first question is from Gonzalo Atia from Danske Bank.

Congrats on good quarter. And my first question is on Buvidal. You mentioned in the report strong performance in Nordics, Germany, in France. Just to get some clarity here, is the growth this quarter in any part driven by stocking in any of these regions that we should account for future estimates. And how should we look at these regions forward? And I'll continue with another question after.

Okay. I'll leave it to Richard to respond.

No, it was underlying demand. The growth was broad, as we said, across the countries. You mentioned Nordics, Germany, Spain and France and all considered alongside U.K. growing as well. There were no one-off effects in the quarter.

Great. One question on Q3. I mean Q3 tends to not be the best quarter for Buvidal in Europe due to the holiday season. How much are you guys expecting this to affect Q3 is the second half of this year, especially back end loaded in your estimate? Or how should we see this?

I think it's difficult to give any predictions about Q3. We don't expect to see I mean, generally speaking, we have seen in the past years, we have seen relatively okay Q3 developments. And I think it's too early for us to give any other indications.

Okay. Perfect. And 1 last question. It's on the CRL in the U.S. Could you clarify what is the status of the contract manufacturer you are starting in the U.S. right now. And I know you cannot give much details right now, but what would be the reasons to remain in the contra factor you have in Europe on the back of the 2 CRLs, you have got and not moving straight to the U.S. line with your other partners there?

Well, I think that, to be frank, our current manufacturer has been capable and able to deliver. Unfortunately, we have this CRL, so that's something we are accounting for. But strategically, we have decided to build out and make sure that we are not sitting with 1 single manufacturing unit, so we need to have broader capabilities and that's the reason. But I don't think we can say anything further on that. If you're looking at the commercial supply performance and also the regulatory discussions with other authorities, we have not seen any issues with current supply.

The next question is from Roni Kolomela.

This is Sai on for Romi. So I have 2 questions. You noted that the outstanding FDA comments have been addressed and that a further regulatory update is soon for the OkrayU.S. -- approval. Can you maybe help us understand what still needs to happen before this resubmission? And if you still think this is going to be a 2026 resubmission or if it's more likely for 2027?

So from our standpoint, remediations have been completed, and that means remediations in relation to the CRL we received on the tenth of June this year. As you know, these were, as we say, third-party related. On the other hand, there was a small point also on this oxygen scavenger and that has been also addressed so we are hopeful that we will have a resubmission confirmation as soon as possible that we are not giving any further details at this moment. But I think 2026 is clearly an opportunity.

Okay. And my second question is, are you able to outline the differences between the 2 CRLs that you received?

Not really because, I mean, essentially, they were very similar in the sense that there had not been an inspection and therefore, you can say that the earlier remained. So that's the situation. We believe the manufacturer has been in contact with the agency, and we believe that this communication and also provided inspection readiness declaration. So we are expecting the agency and most likely, we'll do an inspection at some point but it's obviously FDA on the table of FDA and not us.

Yes. Next question is from Shan Ham from Jefferies.

I've got 3, if I may. Just to continue on the Orkla CRL. Has the manufacturer communicated that they expect an inspection to definitely happen this time around? Or is that still uncertain?

I would say that considering circumstances, it's highly likely that there will be an inspection of the manufacturer.

Understood. And then my second question, please. Is that a ballpark figure you could provide us with on the size of the Brabant sales force in the U.S.? And what kind of commercial investments are being made there?

Well, I think not aside from what we have said earlier. I can't say that they have made a significant addition to both its commercial customer-facing sales force and medical in the last quarter and on a size wise, they are on par with -- currently on par with with other companies in the space.

Understood. And then my final question, if I may. At what point during the year, will you get sort of further visibility into supply for Buvidal to the U.K. should we be expecting an acceleration in the second half of this year based on your current visibility?

I think, as Richard said, I mean, I think right now, we have a process where we have a lot of contributors behind our growth, and we are expecting the U.K. to develop in a positive direction. I mean it's difficult to give you any direct indications of when is -- but we are already seeing some positive trends. So overall, we think that, that will be helpful. And obviously, there are also other discussions and processes ongoing. So we will see how it evolves but so far, it's looking positive. And I think the most important thing is that we see stable growth across European markets at this point, as Richard already alluded to.

[indiscernible] compared to securities. Please go ahead, Philip.

I've got a couple of questions on Australia here where you seem to have had a bit of a cautious tone in the report. So firstly, just on the competitor here that we're drawing towards the end of this year. So we now have 80% market share approximately. So do you anticipate capturing those last 20% sale quickly during 2027? Or how should we think about the dynamics there? Or do you think some patients will switch back to orals, for instance?