Welcome to day two of the Jefferies conference. I'm Brian Balchin, Jefferies mid-cap biopharma analyst, and it's my pleasure to be hosting CEO of Camurus Fredrik Tiberg. Fredrik, thanks for being here.
Thank you so much. Thank you, Brian. It's great to be here today.
Let's try and keep this interactive, so if anyone from the audience has any questions, just raise your hand. I think we've got a microphone in the back, so yeah. Maybe just to, yeah, maybe just to kick off, if you could just give us high-level takes of, you know, how things have gone this year. You had a very good set of results last Thursday. You upgraded guidance on the 23rd of October. Maybe you can just talk a little bit about that.
Yeah.
I think your ambition for 2027 is still to 5x revenue growth, operating margin of 50%.
Yeah.
So you can just help talk about the moving parts there, please.
Yeah, thanks. Thanks. Yeah, I think, I mean, we're very happy with the performance this year so far, and I think what we have done very well is our operational performance has been excellent, both in the commercial setting as well as in R&D, and that's resulted in a very strong financial performance. We had a 60% growth in the quarter in revenues to SEK 384 million, and year to date we have about SEK 1.3 billion in revenue, so that's very strong from that standpoint. Our profit before taxes was SEK 110 million in the quarter, and I think we're up about SEK 500 million so far this year, so it's, it's, it's looking good. And I think the most important part is, of course, that our cash position is solid.
We have about SEK 1.1 billion in cash, no debt, and that in itself is not the most important, but we can actually execute on our strategy going forward, both the very interesting development programs we have ongoing in the company and the establishment of a U.S. commercial infrastructure, which is ongoing for our planned launch late next year of the next product, CAM2029. So that's some of the things.
Great. Fantastic. Maybe just talking a little bit about your key growth driver, Buvidal, in opioid use disorder. Can you just discuss the latest dynamics across all the geographies, Australia, what's going on there?
Yeah. So, I mean, Buvidal, we launched 2019, so it's been on the market, it's been growing steadily since then. We have had 19 quarters, I think now, of consecutive quarter-on-quarter growth with the product, so it's performing well. We are receiving really good feedback from the market overall, so that's important. We launched in Australia and Europe about the same time. And in Europe we have had, I mean, it's always the small countries have been growing really rapidly. We have countries like Finland where we have 70% of all patients are being treated with Buvidal, and we're still growing the market. So that's very interesting dynamic. We're starting to see in Europe the bigger countries coming in. I mean, U.K., we had good uptake in Scotland and Wales, but we were struggling in England, mainly because of financing.
But through, you know, efforts in the system, funding has been made available to UK physicians, and the UK is now one of our best performing markets. So it's good to see that we're going from the small countries to bigger. Australia has been growing very nicely since start. We have a strong position both in the open treatment settings, but also in the criminal justice system, where we basically, I think, now we have around 80% of all, 80% market share of all long-acting products in Australia, so we've got a really good position there. What has happened right now is that the Australian government has changed the payment system, you can say, from a one-payer system to multiple payers, much like we have in Europe here.
So there is some turbulence in terms of, you know, stock-ups and so forth right now, but we believe that it will be over before the end of this year, and becoming more kind of predictable. But it's doing very well in the Australian market, and one of the most important things that has happened is that the government also decreased the copay for patients, so we believe that that will result in an increased uptake of, sales in or patients coming into treatment in Australia going forward. So, so we think that we have continued strong growth ahead of us, and so far we don't see any decrease in the growth rates. On the contrary, I think we have bigger and bigger opportunities, so we foresee continued growth for many years, is my expectations.
Great. You launched in Italy, right, in the third year?
Yeah, well, actually, Italy is a special case because we didn't come to complete terms with AIFA, which is the pricing body there, so we did launch through a partner, Molteni, which is a very strong, experienced partner in Italy. They have been in this opioid dependence treatment market for ages, you could say, and they have a very strong infrastructure, so we chose to have them launching Buvidal in Italy instead.
Great, fantastic. Maybe on to Brixadi, which I think your partner, Braeburn, launched in September. You get mid, mid-teens royalties?
Yeah, yeah.
Can you just talk a little bit about what the latest developments are there?
Yeah, I mean, obviously we've been waiting for this launch for quite some time, and it started out the 5th of September, so in the quarter we had relatively short experience in the U.S. market. But so far we are very happy with what Braeburn has been doing. They have invested heavily into their commercial setup, so they have more than 100 people focused solely on this asset and developing the market. So I'm extremely pleased with that side of the story. Looking at the uptake, it looks very promising. I know they have good access both in Medicaid, increasingly also with private payers, so we are working on following that. Initially we got, I think, around $1 million or so in initial royalties, so sales have started.
It's too early to say how well it's going, but my predictions, and as I understand it, the access looks good.
Okay.
The pricing strategy, I think, was very wise, and hopefully, you know, this will be a success story. That's our ambition, joint ambition, I should say.
Great, and this has got to be a blockbuster opportunity, hasn't it?
Yeah, well, our estimates is that Brixadi peak sale should be about $1 billion, yes. We're, I mean, it's always, at this early stage, it's always difficult to say, but I think, I mean, that is our clear ambition to see that, and maybe above that as well.
Okay, thank you.
That means that it would be market penetration of maybe 6%-7%, which I think is lower than we have anywhere in the rest of the world.
That $1 billion assumes market penetration of 6%?
Maybe 7%. It depends, of course, but of existing patients, yeah.
Got it.
All patients that are in treatment for opioid use disorder, which is the U.S. indication, yeah.
Okay, got it. Maybe it's too early to tell, but can you talk a little bit about the switching dynamic maybe with Indivior's Sublocade and how you view differentiation?
I mean, from a differentiation standpoint, I think, I mean, there are many different aspects of that. Just as a product perspective, Buvidal offers much more flexibility. It's got both weekly and monthly dosing regimens, so you can initiate patients from day one on therapy with Buvidal, whereas with the current product you need to start with oral treatment. It's a much smaller dose volume, smaller needle, etc., but, and you can inject into different injection sites, which is convenient for patients and for physicians because, you don't have to, inject into the abdomen.
Yeah.
In addition to that, we have strong clinical data head-to-head against standard of care, so we have demonstrated both non-inferiority and superiority versus standard of care, so in that sense we have a strong clinical differentiation, and we know the performance in the markets where we are present today together, we have a very strong position. On the other hand, I think it's, you know, both Indivior and these two products are complementary, and I think, you know, building the market together will be a better thing than building it alone.
Great.
In terms of switching between products, it's too early to say. I think we know from Australia that we have switching in both directions.
Okay.
Yeah, I mean, we are all for patient choice, so that's a good thing for us.
Great, thanks. I think an additional, differentiating factor is that yours can be stored at room temperature throughout, whereas theirs needs refrigeration.
Yeah, that's true, and that makes a difference because, I mean, if you're out somewhere, just having a locked refrigerator is not something that every physician has available to them in the system, so that's a benefit, of course, yeah.
Great, thank you. Maybe now onto your pipeline, CAM2029, your octreotide long-acting. I think that seems to be quite a big label expansion opportunity. I think you've guided for three indications: acromegaly, GEP-NET, and PLD.
Yeah.
collectively over $2 billion peak, peak, I think, is it?
Yeah, that's our expectation.
Maybe just talk a little bit about just given positive phase 3 in acromegaly in June, what the latest there is in terms of submissions and.
Yeah. So, I mean, for this program, which is a long-acting octreotide for treatment of three rare disease indications, in the first case, acromegaly, we had positive phase 3 top-line results in a randomized controlled study against placebo, and that came out in end of June. And then we had the long-term study that we announced in July sometime, mid-July, I think. Both showed good control of biochemical markers, which is insulin-like growth factor 1. But most, more importantly, to some degree, I think, you know, connected to the profile we are developing, we had very positive feedback on quality of life of patients, where we saw clear improvements from standard of care at baseline in the trial. Also, patient treatment satisfaction was very, very high in the study and so forth. We had a meeting now with the U.S.
FDA or two meetings, pre-NDA meetings, 1 for chemistry manufacturing and controls, which was very positive, and then another positive meeting on the preclinical and clinical development program. So we have had discussed this with the agency, to my understanding, as I was in the meeting, you know, we're fully aligned on the program, so we are now just trying to complete all the documents and submit around the end of the year this year in acromegaly. In gastroenteropancreatic neuroendocrine tumors, which is slow-growing tumors in the gastrointestinal system, it's the biggest opportunity here. There we are conducting a phase 3, actually the biggest ever phase 3 trial with this type of mechanism of action to demonstrate superiority against standard of care, in terms of progression-free survival. So that's a very interesting program.
We have about almost 100 sites or 103 sites around the world from Canada to Australia participating in the trial. It's progressing very well, great response, and we are hoping to have the last patient enrolled here in; we're not hoping. We are going to have the last patient enrolled in Q4.
Okay.
In that trial, and of course then we have to follow the progression-free, or the progression events until we have enough events to be able to read out this study and have a, you know, a final endpoint ready.
Great, fantastic. Maybe before we get stuck into the specifics of GEP-NET in terms of how that study is designed, for the launch of acromegaly, how do you tend to go about that? Is the intention to partner out, or are you looking to establish your own U.S. commercial infrastructure?
So we are looking at the different markets. The first submission will be in the U.S., yeah, and anticipation with regards to review times and so forth, we could foresee a PDUFA in Q4, okay, next year, and we're now working setting up our commercial infrastructure in the U.S. We're going to have, you know, we have all functions operating now or preparing for the launch, and we are going to be fully launch-ready in Q4 next year.
Okay, great. So for Q24, okay.
So the focus now is on, you know, the distribution model, market access, market research, etc., and, that's going very well.
Fantastic. Some feedback that I've had are concerns on competitive risk there, specifically Crinetics, paltusotine. Just maybe thoughts there on.
Yeah, paltusotine is from Crinetics. It's an oral medication, for that, you know, once daily, taken at fasting conditions. I think paltusotine is more interesting than currently there is one product in the market called Mycapssa, which has not done very well, but I think paltusotine has a more interesting profile in the sense that it's not two times daily versus one times daily. Yeah, the strength of our profile is that we offer a very convenient administration, for a compound and an administration route that physicians are very comfortable with. I mean, basically all patients now are treated with long-term injectables, and we are offering this, but with much more convenience and with higher exposure and the potential for improved efficacy. So I think, you know, and then from an indication standpoint, their primary indication is acromegaly, as we are.
They don't, at this point, have a development program in tumor control in neuroendocrine tumors, which is by far the biggest opportunity here. So I think we are well positioned both from a product competitive standpoint and, you know, you can't expect to be the only person acting in a market. You have to make sure that you can compete in the market with strong enough product, and we believe we have that. But I think it's good to get more choice, so.
Okay, great, thanks. Maybe now onto the larger opportunity, GEP-NET. You've spoken about timelines. That's a study that's designed to show superiority, right? Correct, versus Novartis's Sandostatin long-acting, and Ipsen's Somatuline. So how confident are you, and how is the study designed such that, you know, you've got the confidence for positive?
Yeah, so when we did the powering of the study, which is obviously was a couple of years ago, you know, we, we reviewed all the available data for dose response, and exposure response, and we came up, we thought it would, you know, we should be able to conveniently with the hazard ratio of 0.65 that we are using in the trial. We are expecting to be able to demonstrate superiority. In reality, that means that if we can show a treatment difference of 25%, you know, we should be home with, with the trial, with the number of patients that we have. And, yeah, we, we, we don't feel less confident today than, than we did then. It's, it's, and the study is moving on very nicely.
We recruited 1.5 years, 340 patients before previous studies took up to, I think, 7 years to recruit this amount. So we've had really great feedback from the market and from our physicians. We have one really good investigator in Spain who has recruited over 25 patients in this trial in this difficult indication. So it's going very well, I would say.
Fantastic. I also note in the study, it's designed to dose once every two weeks versus once monthly. Is that to ensure you've got sufficient therapeutic plasma levels to sustain?
Yeah, I think.
And then show that superiority.
Yeah. Well, I mean, both yes and no. I mean, if because we have this very convenient dosing regimen, it gives us a window that, you know, with very high exposure throughout, and that's why we have biweekly dosing. And, you know, it gives, I think it gives us further advantages in this indication compared to acromegaly, where we can exploit the high exposure.
Great. What maybe to physicians who are less familiar with the study and the drug, they've said that, oh, their study is designed twice every two weeks. That's not convenient, you know, because of the clinic visits.
Well, the thing is that we don't need clinic visits because the product is designed for home administration. So it, I mean, it's like similar pen that is used for Wegovy for every weekly administration. So it's a simple automatic pen device that you just push against the subcutaneous tissue, and it administers those in six seconds or so. So it's very convenient for patients. So we are not, that's the important thing. We're not linked to the treatment or the clinic visits that previous products have been.
Great, fantastic. Maybe on then the third indication, PLD. What's the latest there?
So in polycystic liver disease, we have a combined phase two, three systemic study ongoing. This is an indication where there's currently no approved medication. Okay, so we are conducting that. We have, you know, we're closing in on completing the recruitment. It's a randomized trial, two doses of two dose regimens of CAM2029 versus placebo. And we are looking at liver volume and decrease in liver volume and also own developed patient-reported outcomes tool for symptoms, yeah, which we call PLDS. And that is under validation. So we believe that, you know, we're doing very well in terms of progress and we'll have all patients enrolled by first quarter, at least next year, maybe even earlier.
Okay, fantastic. So if we were to size all those three opportunities, it would go GEP-NET first, PLD, and then acromegaly in terms of that.
Yeah, I think, you know, acromegaly is about, you know, somewhere $250 million. GEP-NET is, you know, one point in the U.S., $1.2-$1.5 billion, according to the market research. We're actually updating that now. So we'll see how it comes. Then, PLD is somewhere in between those two opportunities.
Okay, great. Just before I go into the other pipeline assets, I'll just pause to see if there are any questions from the audience. I think we're good, but yeah. Maybe interesting is the asset you have, CAM4072, I think it's out licensed to Rhythm for genetic obesity disorders. Yeah, because I can just talk a little bit about that.
Well, I mean, I should say that that's Rhythm's program. Rhythm is the one, you know, owning the product. So they are, it's a licensed deal with us. And, and we're, so it's, it's a genetic obesity disease targeted product focused on various different, very small ultra-orphan indications, yeah, including Bardet-Biedl Syndrome. I mean, it's being expanded out to larger indications. The sales today are, I think they're somewhere going towards about $100 million so far, but I mean, it's being expanded into more indications as, and there seems to be a very positive view on, hypothalamic obesity indication, for instance, or not ophthalmic. Sorry, I missed out there on the, but I mean, overall, I think it's better to look at what the analysts are viewing, how they are viewing the opportunity, but it's, it's being expanded into several different indications.
Great. And then there's an asset, I don't think we've had an update on this yet, CAM2038, in chronic pain.
Yeah. No, so we're working on the lifecycle management for the whole Buvidal-Brixadi complex, especially with our, in our case, focused on Buvidal. And we are, that is part of that lifecycle management effort that we are doing. And we'll come back to that hopefully before the end of the year or sometime early next year.
Fantastic. Maybe just run out of the pipeline, CAM2043 in pulmonary arterial hypertension. I think last week we had was a phase 2 in April, that you presented. So what's the latest there? Just, just.
Yeah, well, that program right now, we are focusing completely on the phase three trials that we are up and ongoing. I think updates will also there come in the first quarter next year. We are focusing on the pulmonary arterial hypertension program. I think it's the less prioritized of the two developments that we're working on.
Got it. Yeah. I think, so I think I've covered hopefully most of the assets and the business, but in closing, was there anything you'd like to share with the audience?
No, I think we are going very well as our financial position is, of course, very strong at this point, but more importantly, our operational performance continues to be very positive. And we have multiple new opportunities coming forward here. We're submitting the NDA shortly. We'll have data coming up later on with the NET indication, and we have multiple partnerships ongoing. But hopefully we'll also provide news flow in, you know, the foreseeable future here. So we're looking very positive on all developments, and the commercial engine is going well as well. So happy with that.
Fantastic. Thank you, Fredrik, and thanks to all here. Thanks very much.
Thank you.