Earnings Labs

Indivior Pharmaceuticals Inc (INDV)

Q2 2018 Earnings Call· Wed, Jul 25, 2018

$34.23

-0.23%

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Transcript

Shaun Thaxter

Management

Okay. Good morning, everybody, and welcome to our first-half results presentation at Indivior, where I am pleased to share with you the progress we are making and our next steps as we continue to strengthen our global leadership position in the treatment of addictions. I will assume that you’ve all read the forward-looking statements. Today, I am going to give an overview of our performance and talk about SUBLOCADE, where we’re at with the launch, understanding some of the dynamics in the market and a look at what comes next. And Javier will give us a legal update. Obviously, we’ve been very busy with the litigation matters in the last few weeks. So we will get a clear update from Javier. Then Mark will take us through the financial review, before I summarize at the end. So let’s first look at the first-half and our position on guidance for the year. Well, clearly, we have a tremendously intense number of competitor pressures bearing on our base business at the moment. And this is reflected in our net revenue, which is 5% down over prior year. The market growth in the U.S. continues, and this is happening at a very healthy rate. But the shape and the mix of this growth is predominately coming from the Medicaid channel. And this channel is of course the lower margin channel for our business that carries the highest number of rebates. So the growth that we’re seeing is in the lower margin business. And we’ve also seen a loss of some film share. So while we’re very pleased that the film share is very resilient, there is inevitability about some of these competitor pressures, and further enhanced by the fact that the generic tablet pricing has now reached the top-end of the commodity price…

Javier Rodriguez

Management

Thank you, Shaun, and good day, everyone. As Shaun stated in his introduction we’ve adjusted our legal provision related to major litigation. Based on facts available to us at this time, the provision, the revised provision is reflected on this slide and also in our half year results release. Moving on to ANDA. We are continuing to vigorously defend our patent rights to SUBOXONE Film, which were again recently tested following FDA’s approval of Dr. Reddy’s Laboratories generic buprenorphine/naloxone SUBOXONE Film product and DRL’s subsequent launch of this product at risk. The subsequent events beginning with DRL’s product approval and at risk launch are summarized on this slide and described in further detail on our half year results release. The two key takeaways, however, from these events that I want to highlight for you are: one, we reacted immediately to DRL’s launch, and we’re successful in reestablishing the status quo for our SUBOXONE Film patent exclusivity through a court ordered, temporary restraining order and subsequent preliminary injunction; and two, that DRL is aggressively continuing to challenge the status quo. DRL has appealed the PI ruling, and they have also filed emergency motions seeking to expedite the appeal on the PI, and to stay the PI pending a ruling on appeal. We have opposed these motions and are continuing to vigorously pursue the broader appeal of the District Court’s ‘514 patent non-infringement ruling and the recently filed litigation asserting the ‘305 patent. Of course, in parallel with this pursuit, we will also continue to explore the possibility of settling these outstanding litigations as we have previously done with Mylan and Par. In terms of our current understanding as to how the estimated timing of these proceedings are likely or may play out, I’d like to draw your attention to this slide,…

Mark Crossley

Management

Thanks, Javier. Good morning, everybody. As always, we appreciate your time and your attention to the Indivior story. I’ll take you through the first half financial performance as well as then review the overall financial position. Starting with an overview of the profit and loss account on an adjusted basis, which eliminates the effects of exceptional items. As always, we’ve provided a full reconciliation of the impacts of these exceptional items in the appendix of our published slides for your convenience. Overall, looking at the performance for both the first half of 2018 and the most recent quarter, you see the year-over-year impact to operating profit and margin from the lower sales and our higher level of investment in the SUBLOCADE launch. I’ll provide more detail on the drivers for each key line item in a moment. What I will note at the start of this, is that the year-over-year comparison was always likely to be more difficult in the first half given the back-end loading of our infrastructure and organizational investments in the late-stage assets in 2017, combined with the half-2 ramp-up of the SUBLOCADE net revenues in 2018. You’ll recall we added $40 million to $60 million in incremental investments in 2017 to support the launch of SUBLOCADE and to a lesser extent, investment behind RBP-7000. These investments were naturally phased to the back half of last year, given approval and launch timing of SUBLOCADE. In the most recent period, we’ve seen an annualization of a portion of these investments, chiefly, the in-support hub for SUBLOCADE, field reimbursement specialists as well as the medical science liaisons. All of these investments are actively engaged with the physician, the patient and the prescription journeys that Shaun spoke to you earlier. Further there’s also incremental investment behind the organizational start-up of…

Shaun Thaxter

Management

Okay. Thank you, Mark. So clearly, we have plenty going on at the moment. The fundamentals of the business, I think, it remains strong and encouraging. Our existing film business is obviously being impacted by sort of known risks. And you sort of have a feeling, well, all these risks seem to be arriving at once, but obviously, they’re outside our control. Our job is to respond to those risks and vision forward the pathway to deal with those as effectively as we can. I think, we’ve seen from our legal function that we are running a capable campaign there, with key successes under our belt. And I think if you, once again, look at the presentation Javier has tried to vision forwards, what are the moments in time, when some of the cards turn on these generic risks to help you, as you think through your models and think about the future of the business, I can see some of those milestones as well. We are pleased with many elements of the start to SUBLOCADE. But clearly, we have to be self-effacing and recognize, we’ve got a lot of work to do, and we have to do a lot of that work better. So we will remain focused on that. Our first quarter’s focus has been primarily on the prescription journey. Now that we start crossing those issues off the list, we will be spending the next two quarters focusing intensely on the physician and the patient and generating more trial as we also optimize the conversion of trial into actual treatment. We’re also very excited and hopeful of RBP-7000. The FDA is due to give us the decision on Saturday. So they may do it Friday. They may do it Monday. Obviously, we’re very close to the end…

Q - Christian Glennie

Management

Hi, it’s Christian Glennie with Stifel. Just firstly on the treatment adherence rates, and the chart you’ve got, obviously, it’s early days in terms of the numbers there. But just on the March patients, what was the actual number of patients in that cohort? And then, secondly, just for context as well on the – what you would typically see on a two and a three month adherence or retention rate for SUBOXONE Film.

Shaun Thaxter

Management

Okay. I have the numbers on the top of my head for March. In terms of the film, these are similar or slightly better than we would expect to see for the film. But again, it’s very early days, very difficult to draw direct comparisons.

Christian Glennie

Management

Okay. And then on – you talked a lot about the – one of the issues, pretreatment or some anxiety around how they’re going to cope on it without having something to reach on a daily basis. We’ve heard that there are people, as part of dealing with that, would give them a SUBOXONE Film prescription potentially alongside of SUBLOCADE, just as a safety net if you like or slightly a psychological thing maybe. Is that something you’ve observed? And is it something that anybody – any patients are ever having to reach for that daily med as well?

Shaun Thaxter

Management

Well, I can’t guarantee or now what happens with every single patient. So – but what I can say is that the data that we’ve had from the clinical studies certainly do not suggest any need for daily supplementation. We certainly wouldn’t be recommending it, and we’re certainly not hearing of that as an issue or a problem. Now always, there may be a patient and a doctor or more than that that wants that reassurance. But I think that as the technology plays out, doctors will have greater confidence, because they’re saying, you know what, in all my other patients I’m not seeing that. So that will inform. But until you’ve actually got that experience and got that confidence under your belt, then doctors are going to approach this differently. But certainly, we are not advocating that there’s a need for supplemental daily dosing. In fact, we believe the strength of the technology is that that’s not required. But obviously, individual doctors will have to get comfortable with the experience of that. Next question?

Harry Sephton

Management

Hi, there, Harry Sephton from Jefferies. Thank you for taking my questions. So on R&D, for the first half of the year, we saw spend fall by about $10 million compared to last year. I just wanted to get some idea on whether there are specific savings, potentially contingency savings in there or – and whether that’s just a lower degree of studies going on in 2018?

Mark Crossley

Management

Yes, for the first half of the year, the reduction in R&D spend is just phasing in activity based on where we were and coming out of the approval, lining up the Phase 4s, in the balance to go, as we start to look towards the $25 million, we’ll have R&D and the overarching costs kind of in our strategic choices, so.

Harry Sephton

Management

Yeah, that’s helpful. Thanks. And on R&D, you’ve got one of the post-marketing studies to determine whether SUBLOCADE requires initiation of the buprenorphine for the week prior to treatment. When can we probably expect the outcome of that study? And also have you had feedback from any of the physicians as to whether the initiation on the film is actually maybe a barrier to treatment for SUBLOCADE?

Mark Crossley

Management

Yeah, so for that, I mean, that’s discussions that are going on with the FDA. Once we agree on the study protocol, then we can guide you a bit more on the timings with regards to that. From a barrier standpoint, we have not heard that the film is a journey. As we’ve talked through with regards to the prescription journey, almost every patient has to go through that initial prescription journey, where they have to get their prior auth and things like that. And so, no matter what dose you have or whether your indication, there’s going to be a period of time, where you need to enter treatment and be on a sublingual until you can actually get the medication.

Harry Sephton

Management

Okay. Thank you.

Mark Crossley

Management

Next question? Tom, down at the front.

Paul Cuddon

Management

Hey, guys. Thank you. Paul Cuddon from Numis. Can you elaborate possibly on the types of physicians or indeed patients that are completing the journey? I mean, is there a profile of patient that you are specifically targeting? Are you finding that the 275 waived physicians are having more success? And then…

Shaun Thaxter

Management

Yeah, I think there are a number of factors. So we don’t have absolute clarity on exact precision on a number of those questions. In terms of who are the patients we’re targeting, it’s very clear. Anyone with a diagnosis of moderate to severe opioid use disorder is a, call it, eligible candidate for treatment with this medication. In terms of our focus, we focus on the new patients predominantly who are coming in because that’s who we studied in our Phase 3 trials. But any patient is eligible. And one of the things that we’re obviously going to be getting close to over the coming weeks is, well, who are those patients as the physicians are choosing, how do we start to segment out the physicians, the profile, and where they’re at in their adoption journey of the new technology, so that we really optimize our understanding.

Paul Cuddon

Management

And, secondly, Javier, the timing wasn’t quite clear to me as to whether you were saying that, in several days' time we’ll have a decision on the motion to stay the injunction of the decision on the expedited appeal. So perhaps you could just clarify that.

Javier Rodriguez

Management

Right, so what – yesterday, we filed our opposition to those two emergency motions that DRL filed. And so, we expect that the Federal Circuit Court will issue a ruling on those emergency motions, both whether to expedite the appeal and whether to stay the PI pending the appeal.

Shaun Thaxter

Management

So we should hear on both within days. Okay.

Operator

Operator

We will now commence in our audio questions. Our first question is from Nick Nieland from Citi. Please go ahead.

Nick Nieland

Analyst

Hi, I hope you can hear me. Three questions, please. So you’ve reiterated your confidence in SUBLOCADE peak sales. I wonder if you changed your view internally on how long it will take to get to this $1 billion number. And secondly, a quick question on RBP-7000 guidance. Given that this market is $2.5 billion and growing at nearly 20%, do you think that your guidance of $200 million to $300 million in sales is conservative? I wonder if you could remind us of the differentiation of this product and why you think it will get less than 10% of this market in terms of sales. And then finally, for Mark, you’ve guided to high-teens tax rate for the full year. You mentioned tax planning and U.S. tax reform. I wondered how sustainable the lower tax rate seen in the second quarter might be going forward. Thank you.

Shaun Thaxter

Management

Okay. Just remind me the first question again, sorry.

Nick Nieland

Analyst

The first question was about SUBLOCADE peak sales and whether you’ve changed your internal view.

Shaun Thaxter

Management

Well, we have never given a clear view on timing to actually reach the peak. But clearly, we’ve been very transparent that the $2 million in the first half was less than we had forecasted. It’s too early to say whether that impacts the time to peak. We have to see what we learn over the next two or three quarters and see how things develop there. So the second question was relative to RBP-7000. And this is again built on the ATRIGEL platform. This is also a once-a-month treatment. Here, it is for schizophrenia. And one of the key attributes here is that it does not require on-top dosing. So, again, we see that the ATRIGEL platform delivers a consistent plasma concentration across the whole month, so that’s something that we think is important to patients and physicians. With respect to our peak sales guidance of $200 million to $300 million, that is our guidance and that’s what we believe at the moment. When you get into the market and we see how things go, clearly, we will have more data points to guide us. But we don’t want to get ahead of ourselves, because we don’t actually have the approval yet. So, we will continue to work on that technology and, obviously, to try and make it as successful as we possibly can. And our first priority will always be on SUBLOCADE. So as we move forward, no matter how the sort of upsides and downsides of risks play out, we will always give all of our first efforts to SUBLOCADE. And then, there was a question for Mark.

Mark Crossley

Management

Certainly. Nick, on the tax rate, we have seen the 15% through the first half, guided towards high-teens. We think that the revenue mix that’s in the back-half, we still stand behind the 17%. So I don’t expect it to stay with the lower Q2 sort of tax rate.

Nick Nieland

Analyst

Okay. Thank you.

James Vane-Tempest

Analyst

Hi, it’s James Vane-Tempest from Jefferies, just a couple on SUBLOCADE. Just curious, is SUBLOCADE is going to be the main product for the sales force. When you consider the sales force allocation today, how much of it is on SUBLOCADE versus the film? Just curious in terms of the efforts there. And then secondly, just – and I appreciate it’s very early days, but initial feedback from physicians. Are you finding that SUBLOCADE has been more beneficial in stable patients or less stable patients?

Shaun Thaxter

Management

Okay. In terms of sales force allocation time, obviously, the vast majority of the time is spent on SUBLOCADE. But we’re also – they’re really answering questions that our physicians may have on film. So they are serving both the products, but clearly physicians are more hungry for new information, education with respect to SUBLOCADE. So that’s where the vast majority of their time is focused. In terms of the success and which patient profile does better on SUBLOCADE, it’s too early to have a clear view of that at the moment. And as we go through the next weeks and months, we’re looking to understand that.

James Vane-Tempest

Analyst

Thanks.