Operator
Operator
Indivior Pharmaceuticals Inc (INDV)
Q2 2017 Earnings Call· Sat, Jul 29, 2017
$34.23
-0.23%
Operator
Operator
Shaun Thaxter
Management
Okay, good morning, everybody, and welcome to our First Half Results for Indivior and very pleased to see you here today as you join us on our journey as we continue to strengthen our leadership in the treatment of addiction medicine. I'm Shaun Thaxter, the CEO, and I'm delighted to have the opportunity to share with you today some of the key drivers of future value creation in your investment. Before we start, I'll assume that you've read the forward-looking statement in the presentation, and now I'll introduce you to the agenda for today. I will cover some performance highlights briefly before introducing you to Mark Crossley, our CFO, who will take us through the first half financials and share the good news on the revised guidance for the year. Javier Rodriguez will then follow with the legal updates, and Christian will remind of the great progress that we're making in our pipeline before I wrap up at the end of the day. There will of course be time for questions and answers afterwards. So what a great first half it's been. We've very pleased with our performance across the board. Our financial performance has been ahead of plan, driven by 4% growth on the top line. Obviously the opioid epidemic is a very sad thing, it's a great tragedy and many people are in crisis. This is gaining a lot of awareness and attention around the world, particularly in our lead market in the U.S., but we can feel very positive about the fact that more people are finding access to treatment, and this is something that we are very focused on. That in turn of course results in revenue growth for us. So despite a little bit of share loss in the Managed Medicaid sector in the most…
Mark Crossley
Management
Thanks, Shaun, and good afternoon, everyone. I'm delighted to be here to share our first half results, which reflect the team's strong operational execution towards our strategic priorities for 2017. Namely these priorities were Suboxone Film Resilience in the United States, ensuring successful launch of our pipeline products, which are filing NDAs in 2017, expansion of global treatment, as well as continuing to manage our overhangs and pay down our debt. By now I'm sure you've read the release, so I'll take you through the financial results starting with the profit and loss account. We showed the profit and loss account on an adjusted basis, removing the exceptional items to reflect the underlying growth. The nature of these exceptionals are covered in the release, but include the $25million provision for the Amneal settlement in the second quarter that Shaun spoke to earlier. As well as in the base period, our adjustments for ANDA preparation, negative ANDA scenario preparation of $10 million in cost of sales, $4 million in SD&A and there's a $14 million in the exceptional tax impact. On an adjusted basis, what you then see is very solid, underlying year-over-year business performance, with the top line at 4% to $553 million, operating profit of $269 million and net income of $169 million, reflects 27% and 25% growth, respectively. We're expecting this momentum to largely carry through the remainder of 2017 leading to our guidance being raised for the full year 2017, which I'll provide more detail on at the end of the presentation. I'd like to spend a little bit of time on the net revenue trends of the business. Indivior's net revenue increased 4% in the first half, including second quarter growth of 5%. This marks the 6th quarter in a row of year-over-year net revenue growth.…
Javier Rodriguez
Management
Thank you, Mark. Good afternoon, everyone. So in terms of a report on our major legal proceedings as with past practice, I will provide an update on the key developments that have transpired since Q1 of 2017. For a more complete report on these legal proceedings I'll refer you to our annual or half year results announcement. So we have increased our provision for the government investigations and antitrust litigations directed at our U.S. operations by $25 million for a total reserve of $242 million. This increase of $25 million reflects a distinct and final settlement of the antitrust lawsuit brought by Amneal Pharmaceuticals, and in fact, a stipulation to dismiss the lawsuit with prejudice was filed with the court yesterday, and by with prejudice, I mean that the case is dismissed conclusively and cannot be re-filed. The previously recorded provision remains unchanged, as the outstanding legal proceedings remain ongoing. Our discussions with the DOJ continue regarding a possible resolution of their investigation. We're also continuing to cooperate with the states of Connecticut and California in their investigations. There has been no activity on the FTC front; coordinated discovery, however, in the antitrust litigation is continuing with the remaining plaintiffs. We can't predict if we can reach a resolution with any of these other parties although we are encouraged by the settlement that we reached with Amneal. Even if we're able to reach a resolution with these other parties in these open proceedings, we can't predict at this time what the ultimate cost of resolving those matters would be. It's possible that the cost of resolution could be materially higher than what we've recorded in our provision. Within our press release, we have also reminded investors of the risk factors associated with the mutual indemnity provisions in the merger agreement…
Christian Heidbreder
Management
Thank you, Javier, and good afternoon everyone. I will start by giving you an update on the pipeline and first an overview of the Buprenorphine Monthly Depot, RBP-6000. As you know, we filed the NDA successfully at the end of May as per plan. Assuming priority review, we would then launch the product in the first quarter of 2018, and we are waiting for the FDA to give us two key information. First of all, the designation either a priority review or standard review and ultimately the PDUFA date. For schizophrenia, RBP-7000, our monthly Risperidone product, we are completely on track to file the NDA in the fourth quarter of this year. Last but not least, Arbaclofen Placarbil, we are still completing the bioavailability studies as per plan as well, and I will give you a little bit more update on this following slide. So you may remember that we designed 2017 as a series of go/no go milestones based on a reformulation of the product and then a series of characterizations of the pharmacokinetics profile of these new formulations versus the original formulation that we inherited from XenoPort. The first part of the study was to really characterize two new formulations versus the original formulation, that is the pharmacokinetic study in healthy volunteers, and very importantly assessing the interaction of these formulations with alcohol per se. This had been successfully completed and allowed us to move to the second part of the study, which was an optimization of 1 chosen new formulation and determine the full interaction of that chosen formulation versus the original formulation, this as well have been successfully achieved. Last but not least, we took 1 of the chosen new formulations and we are currently preparing a higher dosage strength. We are currently dealing with 15-milligram…
Shaun Thaxter
Management
Thank you, Christian. So just to remind ourselves of what our priorities are for the rest of the year, we will add a bigger picture level of course. We continue to pursue our vision to make sure that patients all around the world can access high-quality treatment. It's important to recognize that as we do that we continue to review and upgrade our operating model, particularly in the area of compliance to make sure that we're able to maintain the right standards and best practice to meet this growth of our business. So if we think sort of narrowly and immediately, clearly we've got key legal risks that we need to resolve that really unlock the real future potential for the company. While those things are going on and in parallel, of course, there is a very, very impressive operational performance across the board. Mark has referred to the passion, the commitment, the dedication and the engagement of everybody in the U.S. business. That's why despite 10 competitors in the market, we still retain 57% market share for the Film, and we believe that Film share will remain resilient as we move forward. We need to make sure that we get it right in terms of our pre-launch preparation and then commercial success for our two once-a-month injectable technologies. Our progress is going very well, and as Mark said, that we are making the relevant investments to make sure that we get this right. As we have said previously, when we do launch there will be a fairly slow build as we get started. Don't look at the tablet-to-film conversion analogs and put that into your models. This is a transformational change. This technology is going to help change the way that doctors practice medicine. So it is a very…
Operator
Operator
We have two questions today.
James Vane Tempest
Management
James Vane Tempest from Jefferies. Just three, if I can, please. I was just wondering from memory, I think in Q1, there was some destocking following the restocking in December ahead of the price increase. Have you seen much changes in the stocking levels in 2Q? That's my first question. Secondly, the termination of the cocaine esterase, whether any costs associated with that and have they being booked in the quarter? And then my third question is just on legal. Can you remind me, is there any link between your sort of position in the DOJ investigation with Reckitt, because earlier this week, they took 318 million pound provision. So I was wondering given that it's a little larger than what you've done, whether there are any nuances we should be aware of that?
Shaun Thaxter
Management
Yes, I'll take the last question and then hand the other two over to Mark. With respect to Reckitt Benckiser, they run their business, we run ours, they're in dialogue with the government. We are in dialogue with the government. The sort of similarity ends there. Really there is no connectivity between these two discussions. The comments that they've made about their provision is what they think is appropriate and relevant to their business and we obviously have our own litigation matters. So I'm not able to comment beyond that, no more than I would litigation in any business. So, Mark, would you like to pick up those first two questions please?
Mark Crossley
Management
Sure. James, with regard to the destocking, the vast majority that destocking happened within the first quarter. I think if you think through kind of the revenue and think about the low-double digit market growth we saw in the U.S. offset with the share loss and the balance is primarily that destocking as the pricing was virtually neutral with regards the price increase and the tactical rebates that we had. And then costs with regard to cocaine esterase, there is a de minimis amount of cost with regards to transferring the asset back to the originator, but it's not impactful to the results.
Shaun Thaxter
Management
Max?
Max Herrmann
Management
Max Herrmann from Stifel; four questions, if I may. Firstly, just a little bit of an update on Europe and the plans for RBP-6000 in the European markets, I know I think previously you had said having expected it to be - take more time, I think last time you mentioned perhaps being able to file by the end of this year. Clearly now, Canada is the focus, so update on that? Also just what's happening with Suboxone in Europe? I believe Generix [ph] last year were able to launch and I wonder what - obviously the market dynamics looked stronger than I was expecting. So, I'd be interested to know what's going on in the market? And then another question just on the pipeline. Given the size of business, there is given RBP-6000 and RBP-7000 are now through and your news on the cocaine esterase program today, was Arbaclofen pretty much your main product in development? There seems to be quite lot of scope for either reducing R&D spend or and launching projects in the pipeline. I wonder what your strategy as any plans there? And just finally, I have asked this before, but methadone, I mean, is that a market opportunity in terms of with expected once monthly has significant advantages over a patient who is going to be chosen to take program by methadone?
Shaun Thaxter
Management
Okay, so let's talk about Europe first. I mean, the European opportunity has always been a challenge you see, takes sort of a couple of steps forward on volume. We've kept more patients in the treatment and a couple of steps on pricing. There are government austerity measures imposed price cut. So although we've got a good profitable business in Europe, the growth is not very interesting at the moment and that position remains. We are encouraged by the conversations that we had with the regulators with respect to the once-a-month buprenorphine depot and the next phase is really to look at European pricing and what the opportunity will be there. Can you just remind me of the last question, please? Oh yes, methadone, right. So we believe very strongly that it's very important that patients have access to a choice of treatment, because our vision is to ensure that patients have got access to care and they get access to treatment. So patients should have a choice and we're not interested in sort of bashing their choice to try and promote our choice. Doctors must make the decision based on what they believe is the right medication for patients. So methadone will continue to be an important choice for doctors to use in the armamentarium and we do believe that patients who are looking for another step towards recovery, patients who are looking for a method of treatment where they won't have to go to the clinic every day to receive a dosing, but can just visit the doctor once a month rather than visit the clinic every day, clearly we would hope that our once-a-month depot product would be a very attractive option for those patients, particularly as we know that it is very effective at maintaining plasma levels above 2 nammograms per milliliter and is the only technology that we are aware of from all the publicly available information that actually sustains those plasma levels across the whole month. And those of you who are well informed which will of course be all of you or most of you, you will have seen what the clinical significance is about plasma concentration from the R&D presentations that Christian has made previously. If you want to remind yourselves they are of course available on the website for you to have a look at. So we think that it is a very positive proposition for physicians and patients. Christian, would you like to speak to the Arbaclofen and pipeline question?
Christian Heidbreder
Management
Yes. So the Arbaclofen Placarbil is moving according to our plan. That said, with regards to new pipeline opportunities, yes, we are actively looking for opportunities currently in the alcohol use disorder to have backup plans, so to speak. But also as I indicated, the opportunities in stimulant use disorder, there is a targeting of patients suffering from cocaine addiction and methamphetamine addiction. As you know, however, there are no advanced opportunities in these areas. So that means that currently the most interesting targets in the non clinical stage and this is why we also very carefully access what the potential and clinical development plans will look like.
Shaun Thaxter
Management
Jason, do we have any questions from online?
Operator
Operator
The first online question which I think is Patrick Chen.
Patrick Chen
Management
Can you hear me guys?
Shaun Thaxter
Management
Hi, Patrick.
Patrick Chen
Management
Hi, thanks for taking my questions. I just have two if I may. First is on the growth rates. So in terms of the market growth a low-double digit, what in your view would you need for this market growth to accelerate any faster? And also secondly, on R&D, could you give us more color in terms of what are you going to, what spend are you going to have on R&D over H2, and why should we see an increase here? Thanks a lot.
Shaun Thaxter
Management
Okay, well I'll speak to the first point. I think what we would like to see, continue to see is that patients have access to treatment. So I think there's a tremendous amount of good work going on across the board from government, from the medical societies. We are doing what we can as a company to provide an appropriate and compliant level support to that whole effort. So we would like more patients to come in for treatment, because that's very good for the patients, it's good for that families and it's good for society. At the same time we want the quality of treatment to be high and appropriate, though this needs to happen at a pace that sustains the quality and the integrity of the treatment model and doesn't create any issues there. Mark, do you want to speak to the second question?
Mark Crossley
Management
Sure. I think just on Christian's presentation, there is still a significant amount of activity going on, on the two primary Phase 3 assets with regards to RBP-6000 and RBP-7000. There is the continued HEOR work. There's the RECOVER study and then there's a lot of teasing and cross-sections of data with regards to where are we going to go with this asset next, as we start to explore lifecycle management and very similar sort of thing with regards to RBP-7000 as we prepare for that. So we expect in the back half to have a higher rate of R&D spend when combined with AP versus the first half, but moderately down year-over-year, $10 million to $15 million or so down in the period with regards to that R&D line.
Patrick Chen
Management
That's great, thanks guys.
Operator
Operator
We have another…
Shaun Thaxter
Management
Next question? Jamie Zimmerman, would you like to go ahead? Thank you.
Unidentified Analyst
Management
Yes, hi good morning.
Shaun Thaxter
Management
Good morning, Jamie.
Unidentified Analyst
Management
So, you know on the one…Good morning, how is everybody. On the once a month depot which we're so excited about and it's so wonderful that it will actually be on the market by the end of this year because I do think it's going to have a huge impact on the opioid problem that we have in this country and we're very excited about - we're very excited about it getting fast tracked. But in the event that it does get fast tracked, it's such a new treatment, it's such a great treatment for patients just in terms of not worrying about compliance, not worrying about abuse, don't you think these patent disputes all disappear? I mean, who will be using this film once the once-a-month depot shows up. It seems to me that the entire market will switch to the once-a-month depot and all this talk about patent infringement overhang is going to be completely mute.
Shaun Thaxter
Management
Well, certainly, we are very encouraged as you are by the new potential of the once-a-month depot has for patients and we very much hope that doctors and patients will see this as a huge step forward. So of course, what the impact is on the total market in terms of the choices that doctors exercise for patients remains to be seen, but like you we are certainly very optimistic that this will bring, it will be a very material advancement and a big step forward for patients.
Unidentified Analyst
Management
And probably totally replace the film. But my other question is merely when you guys separated from Reckitt Benckiser, I believe that there was some sort of separation agreement with a sharing of I gather some sort of responsibilities when it came to anything that went before when you were part of Reckitt. So I understand that you are both separate companies and you might have separate, there might be separate increase from justice, but it's the same harm. So I don't understand at the end when there will be some determination as to what is owed if anything to the U.S. Government? How the amounts can be - there has to be some relationship between what you pay in my estimation and what they pay. You can't get tagged twice for the same wrong. So I'm curious why you think there are separate investigations?
Shaun Thaxter
Management
Well, they are separate, because we're now two separate legal entities and separate companies, so they are separate. There also was not any agreement at the demerger of any sharing of any issues. What we have done, just to be responsible and to make sure that people haven't forgotten, we have reminded people of what the language actually was at the demerger and in the prospectus in this year's, this quarter's earnings statement, we've included that in the risk factors section. I mean without getting into all the nuances, it's a sort of high level mutual indemnification provision. So there is no indication that this event at RB, if there's any intent there, certainly we wouldn't expect anything, but there isn't a mutual sharing of any sort of future liabilities and that's not the language. Is there anything that you would wish to add to that, Javier, or add further clarification?
Javier Rodriguez
Management
Sure. So Jamie, I think what you are referring to is the demerger agreement that we executed to become a standalone entity, and in that agreement there is a mutual indemnity. But because RB hasn't really provided any guidance on the direction the discussions are going or what they may entail, any assessment on our part about the scope and coverage of the indemnity or whether they're going to make a claim for indemnity or whether there are legal grounds to challenge an indemnity is hypothetical and difficult for us to opine on at this point in time.
Unidentified Analyst
Management
But the Justice Department is inquiring about activity that happened when you were actually owned by and part of Reckitt?
Javier Rodriguez
Management
That's correct.
Unidentified Analyst
Management
So it's not something that happened when you were two separate companies, it's not about a future liability, it's about the specific behavior that happened through 2012 and 2013, right? When you were part of Reckitt. So they can't - you can't really fine two people twice, you can't fine, if you get paid once, you don't get paid twice.
Javier Rodriguez
Management
Is that a question or a statement? So, yes, no I think we've...
Unidentified Analyst
Management
[Inaudible] usually you don’t get fined twice, right? So you get fined once.
Javier Rodriguez
Management
Yes, I mean, these are two separate investigations, Jamie, and the situation is that RB have a dialogue with the government, and we have a dialog with the government. And the two discussions happen entirely separately. So we all have a view on the nuances of all of this, but to try and speculate, it is all very hypothetical. So we just don't see any value in speculating on things that are totally unknown. Not trying to be difficult, but you know that is the reality of the situation.
Unidentified Analyst
Management
All right, well [indiscernible] Yes, well I am hoping that they pick up the fine, that's what I'm hoping and congratulations on a great quarter.
Shaun Thaxter
Management
Any further questions online? No? Well, thank you very much indeed everyone for your attention and interest. We look forward to seeing you again in the near future. Thank you.
Operator
Operator
Q - A -