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

Our next presentation is from Camurus.

Thank you for attending the European Biotech Investor Day hosted by Solebury Trout, Goodwin, Deutsche Bank and NASDAQ. My name is Thomas Hoffmann, a Managing Director here at Solebury Trout. Before I introduce the next speaker, I would like to remind you to please feel free to submit your questions throughout the presentation via the web platform. If the company does not have time to answer them during the presentation, they will follow up individually. With that, it is my pleasure to introduce the next speaker, Fredrik Tiberg, CEO of Camurus. Fredrik, please go ahead.

Thank you so much, Thomas. It's a pleasure to present Camurus here and give you an update on our progress of the business. Before doing so, I just want to alert you to the fact that we do have forward-looking statements in this presentation, so please read them and at your leisure afterwards as well. It's available at our home page. So just to introduce our business, Camurus is developing long-acting medications addressing key health care challenges. And we're targeting chronic -- severe chronic indications with a focus on improved treatment outcomes and quality of life of patients. I hope to illustrate this by some product examples further on in the presentation. But first, some company highlights. Camurus, we're a Swedish-based company, rapidly growing commercial stage with a fully operational infrastructure in Europe and Australia. We have a broad late-stage pipeline, recent market approvals. And our development engine is our unique FluidCrystal nanotechnologies, which are used for long-acting depot injectables and has been validated in more than 20 clinical trials and by approved products. In addition to our own developments and commercialization, we also have a number of R&D collaborations as well as commercial collaborations for our approved products. We are listed on NASDAQ, have a market cap of around SEK 7.5 billion and have 130 employees. Our headquarter is in Lund with regional larger offices in Cambridge, U.K., Mannheim and Sydney. Our financial outlook for this year was recently revised in the right direction and we are predicting revenues -- net revenues in the interval of SEK 340 million to SEK 380 million, approximately EUR 34 million to EUR 38 million. And similarly, most of that is sales of our recently launched product, Buvidal. Next, going -- before going into the -- our products and commercial developments, just want to quickly highlight our technology. We have a specific unique technology, which we refer to as the FluidCrystal technology, long-acting release system. And the advantages with this technology is that this does not require any modification of the active ingredient because it is a simple solution that actually transforms in the body to a gel phase, nanostructure gel phase. It is easy and convenient to administer as well as manufacture. It's compatible with a range of drug substances, including small molecules, peptides and proteins. And it's also adaptable to more advanced delivery devices such as prefilled syringes and autoinjectors. We do have -- have originated this technology and have strong intellectual properties around it as well as around the products developed by this means. To illustrate the technology, we have just taken one example here of some clinical data for a peptide called pasireotide. It's a somatostatin analog. And as you can see on the left-hand side, if this peptide is injected in an immediate-release form in an aqueous solution, the plasma concentrations are very rapidly decaying down to subtherapeutic levels from a high peak. If you take the same peptide and put it into the liquid crystalline system, you can see that you go from a very high peak and quick trough to a continuous infusion-like profile. So this is basically the -- an illustration of the performance of this system. I will just jump very radically from this to talking about a very important current health care problem in -- around the world and where we are active, and that is opioid dependence. Opioid dependency is an escalating global health crisis. It's the largest society burden of all drugs. And as you can see on the right-hand side, it has a very significant mortality rate due to, in principle, mostly overdoses. And this -- and we have seen a very negative trend in these numbers across many of the geographies around the world and where Scotland and the U.S. sticks out as particularly exposed regions. In the U.S., it's with almost 50,000 deaths. It's the #1 cause of death for people under 50 years of age. For this purpose and with this in mind, we have developed Buvidal, which is based on our liquid crystalline FluidCrystal technology, which is a flexible, long-acting treatment of patients with opioid dependence. We have developed 2 dosage forms: 1 once weekly and 1 once monthly to address the different needs of patients in their recovery from dependence and during maintenance treatment. Our label in Europe is indicated here. It's for treatment of opioid dependence within the framework of medical, social and psychological treatment in adults and adolescents from 16 years and over. This product was launched in 2019, and I will just illustrate some of the progress that we have done since launching that in Europe and Australia. But before doing so, I just want to refer to some very important features of this product. Buvidal provides significant benefits both to patients and society, and these have been demonstrated in a number of clinical trials. I'll come back to this in the presentation. But among the features that we have shown is that the product improves treatment outcomes and patient satisfaction compared to standard of care. And in this case, we are referring to buprenorphine standard of care, which is daily sublingual medication. It reduces treatment burden and stigma for patients, diminishes diversion because this is administered by health care professionals, so there is no risk of diversion. Sublingual medications, for instance, in Sweden are significantly diverted and ending up, for instance, on the black market. It also, as we will show, has been demonstrating reduced treatment costs in the criminal justice system. One of the most important things for us working with Buvidal is the very positive feedback we get from patients and health care providers. And I think that has been a very positive help for us in the initial launch of the product. So with that, I will move up to our -- describe our initial launch, and the product was first launched in Finland here in Europe in first quarter of 2019. And since then, we have expanded the launch into 7 European countries and Australia. And as you can see, after 5 quarters on the market, varying times, we already had 7,500 patients in treatment with Buvidal at the end of last quarter. Within 12 months, the product has become the market leader in Finland, both in number of patients and in terms of sales, and also market leader in Norway. We have seen rapid uptake in Australia and also seeing accelerated uptake in Sweden, Germany, U.K. and Denmark as market access limitations are continuously addressed. In this, we can also comment on COVID-19 that has been, I think, quite clearly, initially, it was -- it triggered or catalyzed and enhanced uptake. And overall, the effect has been very limited. We are also seeing expanded use of Buvidal in the criminal justice system. So we are continuing our launch and have done very clear advances in terms of addressing access limitations across Europe with new reimbursement approvals in Sweden. We have addressed the remuneration system in Germany for different treatment modalities. We have seen a law change allowing injectable treatments recently here in Austria and allowing buprenorphine or Buvidal onto that market. And we have also expanded the market in Australia from originally only specialists to now also including general practitioners. And the list goes on. So going forward -- let me start here. We are now working to expand into our Wave 2 countries in Europe, and that includes Benelux. Austria, we have just recently launched in. And then we are advancing towards launches in Spain, Italy, and subsequently, France. We don't have a regional strategy for Buvidal. We do have a global strategy. And as I have spoken about, EU, we are launching and driving the commercialization ourselves. It's a big market with approximately 1.3 million high-risk opioid users with a peak market potential of somewhere around -- in the region of EUR 300 million is our estimate. In the U.S., in North America, we have partnered the product with a company called Braeburn Pharmaceuticals from Philadelphia area, and they have the responsibility at this stage. There are approximately 2 million diagnosed patients with opioid use disorder, and the market is estimated to between $0.6 billion and $1.2 billion. In the Middle East and North Africa, we are also working with partners. We have a company called NewBridge Pharmaceuticals. There, we estimate that there are roughly around 300,000 opioid-dependent patients in that region that are addressable with a market potential of between EUR 25 million and EUR 75 million. So we are progressing with the regulatory process with Buvidal, expanding the market. We have submitted new regulatory applications to Switzerland as well as New Zealand and have our first patient treated in the Middle East region and are also working to support our partner, preparing for the U.S. launch. In the U.S., there is a clear path for final approval of Buvidal after FDA granted citizens petitions (sic) [ Citizen Petition ] in November 2019. And there is now a PDUFA date set for Buvidal on 1st of December 2020. Since our last update, we have, however, initiated an arbitration process. There has been an arbitration process initiated, I should say, in England, with regards to the launch of Buvidal and that -- I have it. That -- we -- that is due to a material breach notice that Camurus has issued on our partner Braeburn. We are -- if -- by the FDA's approval, expected to obtain one -- a $35 million milestone payment from our partner. So I think the most important thing to note is that we are also working hard with the evidence base for Buvidal. We're working with a lot of activity in the conferences and scientific publications. We are actually this week at the CPDD meeting with 2 very important presentations about clinical studies that we have recently completed. One very important study that we've presented at that meeting is the DEBUT, Depot Evaluation Buprenorphine Utilization Trial, which is a randomized, multi-site, open-label, active-controlled study of Buvidal versus standard of care in 120 adult outpatients with opioid dependence. The primary end point of this study is patient global satisfaction. And secondary end points were treatment burden, quality of life and opioid-related behaviors as well as general health outcomes. As you can see, this is also a relatively small study, 120 patients. And as you can see on the right-hand side here in the table, we achieved the primary end point and delivered significant superior patient satisfaction compared to standard of care in the study. We also showed significant improvements in terms of convenience and effectiveness of treatment. And further down in our secondary end points, we were able to show improvements in terms of treatment burden and quality of life. A second study that was presented -- the second study that was presented in this meeting was UNLOC-T. It is a study in the custodial setting, prospective, nonrandomized, open-label study in 129 patients. This is one of the first studies done in the criminal justice system of an opioid dependence treatment and also delivered strong results, both in terms of the feasibility of using long-acting injectables in the prison environment. We showed strong data on treatment retention. We also demonstrated that treatment costs with Buvidal was significantly reduced compared to daily methadone as well as sublingual buprenorphine treatments. Following this study, we have seen a very strong uptake for buprenorphine in New South Wales prisons. And this is also being transferred over to other geographies such as Europe and other territories. To finalize here around Buvidal, I would just like to say that we are -- the product is very well differentiated. It's a long-acting treatment -- the only long-acting treatment with both weekly and monthly dosing regimens. It allows for different injection sites, uses small needles and low-dose volumes. It allows for room temperature storage, and we have strong clinical data versus active control. Camurus is -- has a big, broad and diversified pipeline. We are also working with Buvidal and CAM2038 in the chronic pain area and are preparing for a regulatory submission in chronic pain in Europe later this year. We are also having interesting Phase III developments of a long-acting octreotide product called CAM2029 for treatment of acromegaly and neuroendocrine tumors. And I will move over to that in the next slide. So CAM2029 has been designed for enhanced efficacy and patient convenience, and this is illustrated on the next slide here, Slide 21, where you see the current products on the market, Sandostatin LAR and Somatuline Autogel, they both represent approximately 95% of the somatostatin market. However, they have significant limitations in terms of handling and administration and also in some instances, suboptimal treatment outcomes in terms of delivering low plasma concentrations of the active ingredients. To address these limitations, we have developed CAM2029, which offers a simplified dosing and possibility of self-administration. It's developed in 2 versions, both as a prefilled syringe and as an autoinjector. And the autoinjector is a simple subcutaneous that activates by pressure. In addition to the design features, this product also produces significantly higher exposures with a bioavailability that is in the range of 500% higher than Sandostatin. If you look at the market estimates for 2029, these have been sized according to the different features of the product, that is the administration and design features and the clinical possibility of delivering clinical superiority. So for both acromegaly and NET, we estimate the market being in the range of $800 million -- total market is being in the range of $800 million to $1.2 billion. Currently, we have 2 Phase III studies ongoing in acromegaly. The first is an efficacy trial of CAM2029 versus placebo. It's a 6-month study, which has been ongoing since mid last year. And then we also have a long-term safety study called 6 -- the 647 study, recruiting also partial responders, so all-comers, and studying the biomarker levels and safety -- efficacy and safety over 52 weeks. Both these studies are progressing, have had some delays, of course, due to COVID-19, but we are now seeing that patients and clinics are starting to screen and recruit patients again. The overall program for 2029 is quite comprehensive. So we have 2 Phase III studies in -- ongoing in acromegaly. We are in the final preparations of a Phase III study in neuroendocrine tumors and are also in the progress of starting a Phase II study in a new indication. In addition to that, we are performing bridging pharmacokinetic studies of the autoinjector versus prefilled syringe formats. And that is expected to be completed before starting the neuroendocrine tumor trial. To finish off, I think it's also worth noting that we have a number of very interesting partnerships, one with -- which we just delivered new data with, Rhythm Pharmaceuticals in the U.S., where we are working with them to develop a long-acting setmelanotide for treatment of genetic obesity disorders. This active ingredient has shown positive Phase III data and is -- the first NDA has been submitted to the FDA. For the long-acting formulation, we have presented earlier positive Phase Ib data, showing an appropriate plasma half-life of 120 hours and good tolerability. And yesterday, we had the pleasure to see positive data from Rhythm's Phase II study and announced them. And the next step in this collaboration is discussions between Rhythm and FDA about the continued registration of the long-acting setmelanotide. We also have an exciting collaboration with Ra Pharma, another U.S. company, about the long-acting zilucoplan for treatment of complement C5 mediated disorders and have recently also started a number of other collaborations with pharma and biotech companies. So we are anticipating a strong news flow going forward. We have already delivered, as we say, new data just yesterday on the setmelanotide formulation, but we have a number of important milestones ahead of us, including, of course, the U.S. approval of Brixadi for treatment of opioid use disorder. So I think to conclude with, Camurus has multiple levers for growth and value creation. Buvidal and Brixadi, they are -- give us a pathway for establishing leadership in opioid dependence treatment in Europe and Australia. We are waiting for U.S. market approval and launch of Brixadi. And looking at the pipeline, we have a lot of exciting things coming forward, including the completion of the Phase III studies in acromegaly and start of a Phase III study in neuroendocrine tumors. On the corporate side, we are building our -- continuing to build our commercial infrastructure and adding new products. And finally, we are now targeting to reach sustained profitability in the year to come through own sales, partnerships and business development. So with that, thank you so much for listening, and feel free to ask any questions.

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