Earnings Labs

Indivior Pharmaceuticals Inc (INDV)

Q4 2017 Earnings Call· Thu, Feb 15, 2018

$34.23

-0.23%

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Transcript

Shaun Thaxter

Management

Okay. Good morning, everybody. And I can't tell you how pleased and proud I am to be here once again to give you our fourth full year results presentation. I think as our performance has shown, we have really earned the title for the leader in the global treatment of addiction. As most of you know, my name is Shaun Thaxter. I'm the CEO of Indivior and I'm very pleased to be here with you all today. I'll assume that you've read the forward-looking statements, and so, let's look up the agenda for the morning. I will make some opening remarks. And then Mark Crossley, the CFO, will take us through last year's financials. We'll have a legal review from Javier and an R&D update from Christian Heidbreder, our Chief R&D Officer. So we made tremendous progress in the last three years towards our vision to ensure that patients all around the world have access to evidence-based treatments for the chronic relapsing conditions of addiction. We really have made a lot of progress, not only in the U.S., but in Canada and Australia, and in other markets. Let's just focus on some of the key strategic highlights, some of the priorities that we set for ourselves and some of the progress made. The Suboxone Film resilience has been extremely robust in the U.S., well over 50% market share. In fact, average market share of 57% across the year. This is an outstanding achievement in the context of the competitor price pressure that we are now experiencing in the U.S. This reflects not only of the value in the Suboxone Film technology, but also the quality of the relationships that our field force have with treatment providers. We made tremendous progress in our pipeline, not only did we get SUBLOCADE approved,…

Mark Crossley

Management

Thanks, Shaun. Good morning and good afternoon to everyone. Pleased to be here to share Indivior's 2017 financial performance. As you know one of our key strength, our operational excellence and an ability to control the controllables, and as we execute on our growth thesis moving forward. At the start of the year, we shared our strategic priorities for 2017 maintaining SUBOXONE Film's resilience, ensuring the launch - successful launch of our products, expanding global treatment, and continuing the manage our overhangs, pay down the debt and manage the balance sheet. Our full year results demonstrate our delivery on these commitments to you. We grew both the top and bottom line for the second year in a row in the phase of competitive market. Overall results are in line with guidance, which was materially raised at the half year. We generated strong cash flow and exited 2017 with $376 million of net cash. Lastly, we refinanced our debt with three year extension to 2022, a 150 basis point reduction on the coupon and more favorable covenants. Looking forward in 2018, we expect another good year, our guidance reflects the confidence we have in our ability to execute and generate long-term shareholder value. Let's move on to the financial results and start with the income statement. As per normal, we shared our income statement on an adjusted basis to give a clear snapshot on our underlying progress. The nature of the exceptionals are covered in the release, but as expected the vast majority related to the legal provision that Shaun spoke to earlier, and the tax reform which we disclosed a couple of weeks ago. What you see here is another year of good underlying performance, despite intense competition, we delivered the top line at 3%, and with 4% operating profit…

Javier Rodriguez

Management

Thank you, Mark. Good afternoon, everyone. As previously mentioned, we have increased our legal provision for the DOJ investigation and various other legal proceedings to US$438 million in line with accounting rules. As stated in the provision, we are not presently able to predict with any certainty what the ultimate resolution, cost or timing of these proceedings maybe and it's possible that the final aggregate settlement amount could be materially different than what's in the provision. I'm sure that some of you may have questions about the status of the negotiations and the change in the provision, but as I'm sure you can all appreciate given that these legal proceedings are active and ongoing there isn't much more we can say beyond what was disclosed in the full-year press release. Moving onto the ANDA litigation on SUBOXONE Film, we continue to strengthen our IP portfolio. And since the initiation of the original Paragraph IV lawsuits, we have added two additional Orange Book-listed patents to our SUBOXONE Film portfolio. Both of which have been asserted against the ANDA filers. The first of these two patents, the 454 patent was granted to Indivior on June 27, 2017 and asserted against the ANDA filers in September. The expiration date of the 454 patent is August 7, 2029. The second patent, the 221 patent was granted to Aquestive Therapeutics, formerly known as MonoSol Rx on January 2, 2018. Indivior is exclusive licensee of that patent in the field. And that patent was asserted against the ANDA filers on February 7, 2018. The 221 patent has an expiration date of February 14, 2022. Aquestive Therapeutics has received a notice of allowance of yet another third Orange Book-listable patent for SUBOXONE Film. We anticipate that that third patent will grant in early - or late Q1, early Q2 of this year. In terms of the appeal of the August 31, 2017 DRL District Court Ruling, opening briefs in that case were filed by DRL, Watson and Par in mid-January. Our reply to those briefs is now due mid-March. And briefing in the appeals should conclude by the end of May and we anticipate that a ruling by the Federal Circuit will come sometime in Q4 of this year. So that concludes my brief update. I'd like to thank you for your time and attention. And I'll turn it over to Christian for an R&D update.

Christian Heidbreder

Management

Thank you, Javier, and good morning or good afternoon, everyone. Let me start with a little update on SUBLOCADE, with the post-marketing requirement studies and post-marketing commitment studies. So in terms of post-marketing requirement studies, as clearly defined by the FDA in 2011, we have four non-clinical studies. These studies are aiming at understanding the effect of NMP, which is the co-polymer in the ATRIGEL SUBLOCADE formulation, on embryo fetal pre and postnatal development. Two clinical studies that are very important, as they will allow us to better understand how SUBLOCADE actually behaves. The first one is to identify patient populations that may benefit from the higher maintenance dose of SUBLOCADE of 300 milligram. Now, you may remember that during the advisory committee, we already shared data clearly demonstrating that the highest maintenance dose might be beneficial to injector versus non-injector users. So the FDA would like us to elaborate a little bit more that and perhaps even identify additional patients that may benefit again from that higher maintenance dose. The second study is to explore SUBLOCADE, whether SUBLOCADE can be safely initiated without a period of sublingual buprenorphine titration, which is another important question to be addressed. Post-marketing studies are right now translated into two pharmacokinetic modeling and simulation studies on existing data that we collected throughout the clinical development plan. The first one is to identify whether patients may benefit of SUBLOCADE given at a longer inter-dose interval than the monthly dosing that is currently in the label. The second one is to evaluate the transition of patients with long-term stability on sublingual buprenorphine. As you know, this is a very different patient population than the patients that we studied in the Phase III trial. So whether or not we can transition very stable patients on to SUBLOCADE…

Shaun Thaxter

Management

Thank you very much indeed, Christian. I think we've got a lot of interesting things to look forward to in the near future. So just to pull things back together, you can see that all the things that we can control are being controlled very well. We're very well justified based on our performance to claim a leadership position in addiction. In the year ahead, we'll continue to focus on building our SUBOXONE Film resilience, not only do we have two patents asserted, but there is a third on its way, as Javier said, that we anticipate will grant in the near future. We've made the right level of investment. We've got the right capability to make sure that we have two very successful product launches this year. Not only of our once-a-month transformational product for the treatment of opioid use disorder, but also our once-a-month risperidone injection that brings a technology to market that doctors don't have today that they've told us that they would really like to have. We'll continue to expand access to treatment around the world, not only in the U.S., but Canada, Australia and European countries, where there is a real need for our treatments. We'll continue to focus on capital allocation. We'll manage our risks and we will start to prepare for further business development and M&A. So in summary, we're very upbeat. We're very confident. We're ready for the future. We have a lot of known risks that we've managed very well and we look forward to creating future shareholder value with all of you here today. So thank you very much for your attention. And I look forward to helping answer your questions. Max?

Q - Max Stephen Herrmann

Management

Max Herrmann from Stifel. Just a couple of questions. One on SUBLOCADE and just a get feel for, you talked about the sort of pharmacy benefit manager profile. And obviously, you've priced the molecule on approval. What sort of a coverage here you're expecting from the get-go, and then sort of during the course of the year what are you targeting in terms of pharmacy coverage?

Shaun Thaxter

Management

We think we're going to have very good quality coverage. Obviously, the way that coverage, it builds through the year. It's never the case that you go out on day-one and you have full-on formulary access everywhere. Some health plans are able to list very quickly. Some health plans have a mandatory period before they go on to formulary. But we have built a very sort of strong and assertive build of payout coverage across the year. And from the feedback we're getting at the moment, we anticipate we're going to meet those objectives.

Max Stephen Herrmann

Management

Okay. And the second question was just in terms of ex-U.S. for SUBLOCADE. What's the - you've talked before about filing in Europe and filing in Canada. And we've not seen those timeframes. So I just wondered whether you got more clarity on when you will submit.

Shaun Thaxter

Management

We're anticipating submitting this year.

Max Stephen Herrmann

Management

For Australia, Canada and the EU. Is that central filing in Europe, EMA?

Shaun Thaxter

Management

Christian, do you want to…?

Christian Heidbreder

Management

We didn't define our regulatory filing strategy yet.

Matthew Cook

Management

Hi, thanks for taking my questions. It's Matthew Cook for Bank of America. I think you've been very clear that you're expecting the SUBLOCADE launch to build in terms of sales. But could you give us a perspective of what looks like a successful launch for you at the end of 2018? And what sort of metrics we should look at? And then, touching again on the pharmacy benefit managers' side of it, can you explain the relevancy of it being reimbursed more as a medical benefit rather than a pharmacy benefit? And then, one on SUBOXONE Film, in terms of the market share declines that you saw last year, they were heavily weighted towards the first half. You flagged that you could see potential further declines next year. Should we expect a similar sort of seasonality or is there any key contracting decisions that we should expect?

Shaun Thaxter

Management

Okay, so just remind me of the first question. I'm sorry.

Matthew Cook

Management

What are the key metrics you're looking for in the SUBLOCADE…?

Shaun Thaxter

Management

All right, okay. Well, obviously, we've set our financial metrics for the total business. We have a lot of metrics that we're going to be looking at as we go along month-by-month in terms of the progress that we are making. We will be sharing some of those metrics as we move forward. I think we're just sort of thinking what would be the most useful to know that couldn't be misinterpreted. It does in different way. So we're looking at metrics like the number of doctors that have treated at least one patient in the quarter, the number of doctors that have treated five or more patients in the quarter. And we are taking a look at the moment, because we appreciate you need to be able to see how the launch is going. We also know, of course, that the data that go through the specialty pharmacy channel are not publically available. So we are very mindful of that and I look forward to being as helpful as we can. The second question was - sorry?

Matthew Cook

Management

Relevance of medical benefit.

Shaun Thaxter

Management

All right, relevance of medical benefit. Well, the medical benefit tends not to be managed as closely as the pharmacy benefit. But this is something that varies from plan to plan. So we think that we will get the coverage that we're looking for irrespective of whether the plan decides to go down the medical benefit or the pharmacy benefit. Obviously, as this product is administered by the doctor and is injected by the doctor, the doctor also gets an administration fee for administering this into the patient. Mark, did you want to speak to the third question with respect to Film revenues?

Mark Crossley

Management

Matthew, with regards to the phasing of that, I think a reasonable analogue is how things progressed last year. So we'll have the annualization plus we'll have a very similar phasing in the year ahead. The plans are pretty well spread out on the same profile this year. So...

Shaun Thaxter

Management

James?

James Vane-Tempest

Management

Yes, hi, thanks. It's James from Jefferies. Thanks for taking my questions. Just two if I can. With the - I think it's for Mark actually. I think with increasing Medicaid patients driving growth. I notice receivable days have gone up. I'm just curious how long it takes to get paid and this is a trend we should expect to continue. And then last year, you mentioned sort of $40 million to $60 million incremental investments, saying growing a bit this year. How should we think about incremental spend this year, related to SUBLOCADE. Thanks.

Mark Crossley

Management

Certainly. So, James, the way I think about the receivables that you see that are on the balance sheet that are up a bit year-over-year, there is kind of two elements to it, right. One is just a natural increase in the actual volume growth that drives some of that. And then the other is just the phasing of stocking at yearend. We have kind of a consistent level of stocking that the wholesalers do at yearend. It's just that's happened more in December this year, so that the terms haven't come due on those. So that's - nothing on there. We're still very focused on our networking capital. I think we do a very, very strong job there, nothing uncertain there. So with regards to the $40 million to $60 million, we're not talking about an incremental spend year-over-year. But what we have talked about is, we will have this annualization of cost on SUBLOCADE with regards to the FRS, the medical sales liaisons, the hub cost that we'll all carryover and annualize into 2018. We will have the incremental spend as we ramp up the business unit and the sales force associated with RBP-7000. We do not want to distract from the SUBLOCADE launch, so that will be a separate small business unit with regards to that that will have some incremental cost. But those costs are captured within the P&L. And I think if you think about R&D costs, with all the activity Christian has is relatively flat year over year. You can kind back into those, I think in your modeling.

Unidentified Analyst

Management

Thank you. Can I just start off with the proposed changes to Part D in the U.S. for Medicare cover, essentially the incremental gap that's going to have to be covered by the companies? How do you see this impacting the SUBOXONE Film franchise, but also the SUBLOCADE launch as well and the profitability of those products?

Shaun Thaxter

Management

We've done some top-line analysis on that as that's filed. We don't see a hugely material amount there with regards to either franchise going forward. So I wouldn't think of that as anything that's going to be a material focus. It's relatively when Obamacare was put in and some of those changed, but it was relatively modest. I mean, it was - it's a relatively modest change now with regards to what we're expecting.

Unidentified Analyst

Management

Okay. And then, just on the - thinking about the Film franchise going into next year, the exit run rate, just to confirm, was 57%, when you exited for the year. You obviously got the Orexo CVS impact coming through. And then, I'm quite keen to understand what the - if we're thinking about modeling out the film franchise, you've got price up obviously. You got discounting increasing. You got some market share loss. So would you assume that franchise would be flat at best for 2018 and then essentially the variance is essentially is going to be the - how well the SUBLOCADE launch does. And then, on top of that, we see the range of the revenue guide. It's actually quite narrow. And I'm wondering is the delta there, what are the moving parts in your forecast assumptions with that small delta?

Mark Crossley

Management

Actually, we've increased the range on the revenue guidance. Typically, we've been at 30 and we went to 40 to show that there is a little bit more range in there with the launch and with some of the dynamics on the base film. But with regards to the base film, we exited not at 57, 57 was the average share, 57.5. So we actually exited at 55 share-point standpoint. As we think through kind of the general dynamics, I think they're in line with kind of what I talked in the guidance section. We're talking about a high single to low double digits sort of growth as we annualize the legal sort of interventions that happened that opened up access. We'll have more share loss just as a dynamic we have carryover annualization of that share loss we just spoke to, of the 2.5 points. And then, if we expect a similar sort of rate in the next year, you get another average 2.5 that could come out of there. And you take into account the price mix and the pricing situation and our coupon investment, flat to slightly down in the base. If that's what you're working in your modeling, I think is in the ballpark, with the balance being SUBLOCADE.