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

Ladies and gentlemen, welcome to the Camurus Q4 Report 2020. Today, I am pleased to present President and CEO, Fredrik Tiberg. [Operator Instructions] Speakers, please begin.

Thank you so much, and good afternoon, everyone, from a wintry south of Sweden, and welcome to Camurus' Fourth Quarter and Full Year Results Presentation. Next slide, please. Before we start, please note our forward-looking statements on this slide, Slide 3. So in today's call, we will give a brief presentation of our fourth quarter and full year 2020 financial and operational results, provide an update about the commercialization of Buvidal and progress of key pipeline programs, and then we will finish off with an outlook for 2029 -- 2021, followed up by a question-and-answer session. With me in today's call is our Chief Financial Officer, Eva Pinotti-Lindqvist; and Chief Commercial Officer, Richard Jameson. So let's move to Slide 4 and the summary of our achievements in 2020. So we had a successful 2020 with strong revenue growth and advancement of key pipeline programs. Our full year net revenue was SEK 336 million, of which product sales were SEK 323 million, which is in line with our upgraded guidance for 2020. Our full year operational expenses were SEK 508 million, including legal costs for the arbitration process with Braeburn. Despite the significant challenges associated with the COVID-19 pandemic we have been quite successful in our developments, continued the commercialization of Buvidal and expanded into new markets. We established the significant value that Buvidal brings to patients, the health care system and the wider society through clinical studies and real-world experience. And on the R&D side, we continue to advance our Phase III studies of CAM2029 in acromegaly and prepared for start of registration studies in neuroendocrine tumors. Our partner, Rhythm, announced positive Phase II results for long-acting setmelanotide for treatment of rare genetic obesity diseases. And we also progressed our early pipeline, laying the ground for new value-adding clinical programs. Moving over to Slide 5, and this is then the highlights in the fourth quarter. We continued to deliver a solid financial performance with increasing revenues and Buvidal sales exceeding SEK 100 million. And we ended the year with a healthy cash position of SEK 462 million. The number of patients in treatment with Buvidal increased to over 15,000 in the fourth quarter, with more than 200,000 doses administered during 2020. On the regulatory and legal side, we received a market approval for Buvidal in Switzerland, Spain, while, unfortunately, in the U.S., the approval of Brixadi was delayed when Braeburn received a Complete Response Letter from the FDA on the 1st of December 2020. Further, through this, we received a ruling from the arbitration process, where the tribunal concluded that Braeburn was not in material breach of the license agreement at the time of our notice in April 2020. This means that the license agreement continues as previously, including their obligations to develop and commercialize Brixadi in North America. Moving over to the clinical development side. We started dosing in the quarter in 2 studies of our long acting -- well, one study of our long-acting treprostinil CAM2043 in patients with Raynaud's phenomenon, and in a pharmacokinetic study of CAM2029 with a new autoinjector. Finally, we strengthened our IP position for Buvidal and Brixadi with additional patents granted in the U.S. and Europe. And with that short introduction, it is time for me to leave the word to Richard for an update on the commercial side.

Thank you, Fredrik. So we're now on Slide 6, please, just so we are all aligned. As Fredrik just said, we now have more than 15,000 patients receiving Buvidal across our launch markets. And we continue to hear the positive impact the product is having on patients like Sophie in the slide here, who continue to do well with treatment. Treatment centers are sharing the impact Buvidal is having on the treatment of opioid dependence, and there's growing dialogue through both camera-supported and independent medical education programs that highlight the benefit that Buvidal brings to patients and wider society. So if we look at the progress specifically with Buvidal, I'm going to Slide 7, please. In Q4, we continued the progress with Buvidal with invoice sales of 10% over the previous quarter. But with underlying strong in-market sales, we're actually up 33% versus previous quarter. The difference is due to variations in ordering and stockholding in a few markets where Buvidal is purchased directly by wholesalers. Double-digit growth was achieved in the quarter in all our markets with Australia, Finland, Norway and the U.K., representing the largest markets for us. COVID-19 remains ever present and continues to be a catalyst for Buvidal in some countries, with the benefits of stabilizing patients in supporting self-isolation for this vulnerable patient group. The other side of the coin, though, is that the pandemic continues to create some headwind for us due to understandable pressures in ministries of health that have resulted in some delays to pricing and reimbursement approvals. And alongside this, access to health care professionals has been challenging and the prescription journey in some countries impacted by staff shortages. We continue to work closely with a broad group of stakeholders to mitigate these challenges and create new pathways in the patient journey and clearly defined patient profiles to accelerate access to Buvidal. Despite these challenges, we continued to expand in 2020. And with the recent launch and first patients treated in Spain, Buvidal is now available in 15 countries, 11 in Europe with Australia and 3 pre-licensed sales programs ongoing in the MENA region. We're also progressing our wave 3 country launches and have submitted 7 new dossiers for pricing and market -- pricing and reimbursement approvals across the EU and new applications for market authorization submitted during the quarters with others planned in 2021. So if we can go on to the next slide, please, Slide 8. The success of Buvidal has been built on a solid foundation of a strong evidence base, which has demonstrated efficacy and safety versus current standard of care, which has supported the claims that we can make about superior treatment outcomes, which reflects that individualized treatments leads to improved patient satisfaction. And these outcomes are produced in profound case histories that are increasingly being recognized through independent reports across media channels, and there's a few examples from this activity on the slide for both national and local media sources from various countries. Governments are also developing a clear understanding of the value Buvidal brings to wider society. And as an example, you can see a clip on the slide here from the First Minister, Scotland's Nicola Sturgeon, who confirmed last month that long-acting treatments were one of the pillars for them to address the growing tragedy of increasing drug-related deaths in Scotland. If we can move now to Slide 9, please. So now we turn to the regulatory progress in the fourth quarter. We obtained in December new market approval in Switzerland, and we plan to launch in Switzerland in Q2 once the pricing approval has been obtained. We progressed line extension applications in EU and Australia as part of our life cycle management plans, and our application for market authorization in New Zealand is under final review. We've also initiated a regulatory process in the MENA region, where several new MAAs were filed and where priority review status was achieved in Saudi Arabia. We already have a significant number of patients in treatment in MENA, as I said earlier, on early access programs. In the U.S., however, as Fredrik already mentioned, we were expecting approval of Brixadi on the 1st of December, but our license partner, Braeburn disappointingly received a Complete Response Letter resulting from quality deficiencies at the manufacturer. Based on the information we have, we expect a new PDUFA date in the second half of this year. We continue to advance plans for CAM2038 in pain in EU. And following a positive meeting with the EU Rapporteurs, we are preparing a regulatory submission in 2021. So with this, I guess, we move on to Slide 10. I will hand back to Fredrik for an update on the progress on the development pipeline. Fredrik?

Thank you, Richard. And back in Sweden, as you know, Camurus has a broad and diversified pipeline. We are now on Slide 10 here, with an ongoing -- with ongoing development programs from Phase I to registration phase. And today, I will give a brief update on the registration programs for CAM2029, which is one of our most advanced programs. Going to Slide 11 here. CAM2029 is our subcutaneous depot of octreotide, which we have designed specifically with the aim to improve both efficacy and treatment convenience for patients with rare endocrine diseases and neuroendocrine tumors. Slide 12, please. And for those of you who are new to this development, this product addresses key unmet medical needs in the somatostatin analog markets. Somatostatin analogs are first-line medical therapy for acromegaly and neuroendocrine tumors. And the annual sales of the current market leaders, Sandostatin LAR and Somatuline Autogel, alone are currently close to USD 3 billion per year. Despite being recognized as safe and effective, these products are also associated with significant limitations, including inadequate treatment response rates and a very complex handling and administration. CAM2029 addresses these limitations by offering improved treatment exposures, exposures to medication that is, over time, and will be available for self-administration with a state-of-the-art autoinjector. We believe CAM2029 has best-in-class potential in this market as well as significant opportunities also in other indication areas. Slide 13, please. So as you can see on this slide, we do have an extensive late-stage program ongoing with 2029 across 3 rare disease indications. And on the next slide, Slide 14, we show the current status and progress in these different programs. In acromegaly, we have 2 ongoing Phase III studies and are on track for regulatory submissions in late 2022. Moving down to neuroendocrine tumors. We recently got an IND Safe to Proceed letter from the FDA after having aligned the product -- the study design with both the FDA and the EMA and are in the process to start up this Phase III study. In the polycystic liver disease area, we are in the midst of developing a patient-reported outcome questionnaire to be used in a Phase III and Phase II program to be started in the middle of this year according to plans. Finally, we started the pharmacokinetic study of CAM2029 to bridge between the current prefilled syringe format and our new autoinjector, and we will be able to introduce that into Phase III studies after the summer. Next slide, please. So to finish off, we exited 2020 with a strong foundation and are looking forward to positive news flow during 2021 and 2022 as we achieve our various milestones. This includes starting out the Phase III study of CAM2029 in neuroendocrine tumors, obtaining line extension approvals in the EU and Australia and starting registration studies of weekly setmelanotide by Rhythm, and not the least, completing the efficacy trial of CAM2029 in acromegaly. And not to forget, we also, of course, look forward to the potential of the U.S. approval for Brixadi in the second half of the year. So it's an exciting year ahead of us. And moving over to the next slide, please. We can conclude that we continue to deliver on Camurus' strategy by establishing leadership in opioid dependence with Buvidal and launch in new markets. We're advancing and growing our pipeline of innovative medicines towards new regulatory approvals in major markets. And on the corporate level, we are continuing to build our commercial capability to develop and develop sustainable profitability through own sales, partnerships and business development. Next slide, please. So finally, I just want to say a few words about the financial outlook for 2021. Our net revenues are guided in the interval SEK 680 million to SEK 750 million. This excludes any potential milestone or the potential milestone triggered by Brixadi approval in the U.S. We are expecting product sales in the range of SEK 620 million to SEK 680 million. And here, we have also considered the situation with the COVID-19. Our full year operational result is expected between minus SEK 120 million and breakeven. Of course, we are in uncertain times, but we feel comfortable about these numbers at this moment, and we foresee a positive development of our business in 2021. And so with that said, I'm looking forward to any questions in the Q&A. Thank you all, and back to our operator.

[Operator Instructions] Our first question is from Peter Sehested of Handelsbanken.

Yes, it's Peter here. Can you hear me?

Yes.

Okay. Congratulations on the nice outlook for fiscal '21, and I have some questions to that, if I may, please. Fredrik, you said that you are comfortable with the outlook despite the fact that these are uncertain times to me suggests that these times become less uncertain that there could be some upside to your current outlook. Or secondly, that you might have opted to take a conservative view, given that we are in uncertain times. So I just wonder, could you add -- give us some flavor on what kind of market-level optics, et cetera, you have also for the new market in the new guidance, if possible. And just to stay on that tune, you mentioned Spain as a new market coming on stream. Could you add some flavor on more markets coming on stream? And with respect to the 15,000 patients that you say currently have had experience with Buvidal, could you cast some flavor on how much of this is in Continental Europe and how much of this is outside please?

Okay. Thank you, Peter. Well, I think that when it comes to our revenue and product sales estimates, we have tried to incorporate the uncertainties of the COVID-19 epidemic. But I do think that we are also looking at the upside here. Of course, there are possibilities in terms of getting earlier pricing and marketing approvals than expected that may drive sales beyond the limit that we have indicated. But I think we have quite a realistic view on this. And so I would have that as the baseline, at least. When it comes to the growth potential, I think I would like to leave the question over to Richard and talk about the different markets. Continental Europe, of course, is just starting out. Spain, we launched very recently. But Richard, would you like to give any more flavor about the sales in the different regions?

Yes, I can do. I mean, certainly, Spain is our latest market. I mean, we get a very positive response from Spain. It's early days, of course. We are just launching. But certainly, the regional and national drug plans are very supportive of Buvidal and see the benefits it will bring. For new markets, you can imagine the other markets in Europe, we'll be looking at, so the ones we're not in now. So that includes Itlay, Switzerland, Belgium, Greece, Croatia, example. So we're looking at those and have pricing applications in there. I think you had a question about the split between Europe and the other regions. I think Europe is the biggest. The other regions are developing markets, should we say. They don't have big, large treatment systems yet, but the fact they're open to regulatory approvals means that they're looking at this seriously as a needed treatment in those markets. So they will come in over time. Did that answer all your questions?

Yes, I was -- so even taking Australia into account, Europe is still the largest part?

Yes.

Yes, certainly. Yes, Australia is still a large country for us, of course, and it's an important part of the business.

So I think yes, I think what I'm trying to fish out was sort of the patient split between Australia and South West.

I think at this moment, I mean, we have a significant number of patients in Australia. It is absolutely in the range of 1/4 to 1/3 of the total patients. So it's a considerable size -- slice of our overall markets.

Okay. Can I just throw in a follow-up, if I may, on, of course, the U.S. Brixadi and the opportunities, not only in opioid dependency treatment but also in pain and your collaboration with Braeburn. I don't know how much you can say whether you have signed sort of an agreement not to say anything at all. But are you still comfortable with the way that Braeburn is handling things? Are there any options for you to sort of do something yourself on the other side of your clients process with pain, et cetera? Is there anything at all that you can cast some flavor on your respect to what you might be able to do with the U.S.? I guess, Braeburn's preparation for a launch, please?

Yes. I think -- I mean, the important thing is, of course, that we think it was very unfortunate that the NDA was not approved at the PDUFA date. And of course, that's -- to us, it's a big disappointment and also a big disappointment to a lot of the physicians and patients in the U.S. that don't get access to this treatment. At the moment, we are doing everything we can to support in the development and help resolving any issues that we can contribute to. When it comes to Braeburn, I mean, I think there's a good opportunity to contact them, but I think we would give an update as soon as we have a clear understanding of the situation in terms of the exact time lines towards a new approval. And I think I will leave that to them.

Our next question is from Harry Sephton of Jefferies.

My first one is on the expected timing of the CAM2038 submission for chronic pain in Europe. I do understand that that's been slightly delayed from previous expectations, given around this time last year. Can you maybe comment on why that's been pushed out a bit and the likely timing for a launch in that indication? And then my second question is on the European market. Clearly, we've seen a lot of reports in the U.S. about the impact the pandemic is having on the opioid crisis over there. What are you seeing in terms of numbers of patients coming into treatment in Europe and also Australia? That would also be helpful.

Yes. So if we're talking about the chronic pain program, the final studies were completed last year, and we also had a positive discussion with the Rapporteurs about the registration program. What has been a delay, you could say, or conscious one is that we have been looking at the market access strategy for the product and the best way and best timing for a submission. So from a practical perspective, we have everything in place. But from a tactical perspective, we have been looking at the optimal time points for moving in there and also looking at the opportunity of, what should I say, getting the optimal indication for the product, also in the light of the fact that Buvidal is on the market for opioid dependence. So that has been the consideration, and we are working through that -- those strategic aspects right now. So in terms of timing, our current plan is most likely in the second half of this year. And then, Harry, can you repeat the other question about...

Yes. No, absolutely. So it was more on the number of patients coming into treatment for opioid dependence in Europe and Australia and whether you're seeing the pandemic was a spike in the number of patients coming into treatment as we've seen in the U.S.?

Yes. In the U.S., I mean, it is very clear, and there has been recent reports, I think even yesterday, coming in about how the situation is worsening. We don't have any statistical data. At least, I don't have that in Europe, except that we see overdoses are escalating in Scotland, for instance, have continued to do so and are continuing, unfortunately, to do so. We're also seeing an increased tendency of overdoses in some Scandinavian countries. And I do believe that in general, physicians are very concerned about the current situation and that the opioid use is increasing as a function of people being isolated and -- in this situation. Richard, do you have anything further to that?