FYI.. Indivior PLC (INVVY) CEO Shaun Thaxter on Q4 2018 Results - Earnings Call Transcript Feb. 18, 2019 5:19 PM•INVVY Indivior PLC (OTCPK:INVVY) Q4 2018 Earnings Conference Call February 14, 2019 6:30 AM ET Company Participants Shaun Thaxter - CEO Mark Crossley - CFO Javier Rodriguez - Chief Legal Officer Christian Heidbreder - Chief Scientific Officer Conference Call Participants Graham Parry - Bank of America Merrill Lynch Max Herrmann - Stifel Paul Cuddon - Numis Nick Nieland - Citi James Vane-Tempest - Jefferies Shaun Thaxter Okay. Good morning everybody. And welcome to the Full Year Results for 2018 for Indivior. My name is Shaun Thaxter, I'm the Chief Executive Officer. And I'm looking forward today with my colleagues Mark Crossley, Chief Financial Officer; Javier Rodriguez, Chief Legal Officer; and Christian Heidbreder; Chief Scientific Officer to sharing with you the results from last year. Our plans for this year as we continue to pursue our journey towards our vision to ensure that patients all around the world have unrestricted access to evidence based treatments for the chronic relapsing conditions and the co-occurring disorders of addiction. I will assume that you've read the forward-looking statements and our agenda today is I will give an overview then Mark will give a financial report. We'll have a legal update and then we'll look at some new exciting scientific data and progress that's been made in our R&D and medical function last year. Well, clearly, 2018 was a challenging year with net revenues dropping from the prior year. This is reflecting two key drivers. First of all, the intensity of pressure on our SUBOXONE Film franchise in the U.S. from both the tablet sector which had a very downward effect on pricing and rebasing and from the film sector where we had a pulse of entry of generic product from Dr. Reddy's in the middle of last year. The second impact was obviously the SUBLOCADE got off to a slower than expected start, and I look forward to sharing with you the progress and the momentum that we're building on the SUBLOCADE. It is a tragedy that so many people continue to die from opioid overdose. The opioid epidemic continues to rage in America, but the silver lining for the cloud is that the environment, society's attitude, government legislation, regulation, the whole atmospherics and the environment are starting to shift towards being more supportive of treatment. Treatment is now seen as an important part of addressing the opioid crisis. This means that we saw across last year double-digit growth in the volume of buprenorphine medication-assisted treatment, and we believe that this growth will continue. This is a long-term problem. It is going to require a long-term solution and it means that there's a very important role for Indivior to play in the years ahead. Across last year, we were very disciplined and very prudent with our cash. We managed to pay off almost half of our outstanding debt and we continue to put the other cash into investment behind our growth drivers and into -- onto the balance sheet, ending the year with $924 million of cash. We made great progress in our pipeline line, not only did we start last year with the approval of SUBLOCADE we also had to service approved, we have SUBOXONE tablets in China are approved and that we managed to start to implement new studies that would pioneer the disease space, as R&D shifted its focus from Phase III implementation of regulatory approval into post-marketing studies, life cycle studies that will start to drive forwards our understanding of this disease states and create new science that will pave the way for further market development and further expansion of the number of patients that will be able to treat with SUBLOCADE. And Christian has some exciting data to share with you later in the presentation. We have divested our rights to SUBOXONE tables in China to help us focus on our core growth markets in the U.S. And I also have to share with you that two of our early phase assets in the pipeline were just continued. Early phase assets are always very high risk, low probability of success. It's always very important to know when to quit on those assets and when to look at other assets. And Christian will share more about that later. So where does this leave us for 2019 moving forward? Well, clearly, we have a lot of uncertainty about what will the true impact of generic film be on our business. We are still fighting. We're still asserting our intellectual property rights. We're going to the Supreme Court this week to see if we can continue to push on the potential generic entry, next week. Beyond that, we will continue to fight and assert our intellectual property no matter what happens on Monday. If there is generic entry on Monday, it's very hard for us to actually predict what the erosion curves will look like. We've given you the building blocks and some analogs to help guide you and to how you should think about your model and Mark will talk a little bit more about that later. So, we're not able to provide full your guidance for this year. We are, however, very pleased to share that we are issuing guidance of 50 to 70 million on SUBLOCADE, and that we have done a lot of work on our cost space to make sure that it fit for purpose as we enter a potential phase of generic entry with an OpEx of 440 million to 460 million. So there's two real key themes from 2018, we have to get ready for potential generic entry, we have to make sure that we have the right cost base, the right shape of investments, we had to make some choices, and we have to give priority to those things that will drive the greatest value. So from a growth point of view, we conserved our cash, we put it behind SUBLOCADE, we put it behind PERSERIS in the U.S. markets. In the short term, those are the major growth driving opportunities. The Rest of World does have potential, we have progressed our SUBLOCADE filings in some target markets. But for now, the key strategic financial role of Rest of World is to continue to generate that cash flow and to support the rest of the business as we move forward. I've already said, we've voluntarily paid down our debt, we've reduced our operating expenses and we are ready to launch our authorized generic, if required. So that will be done through our partner Sandoz and we are ready and fully prepared for launch. So I'm very proud to be able to say that we’ve started the diversification of risk within our business. The fact that we have a lot of work to do on SUBLOCADE is not prevent us from also launching PERSERIS. Clearly, the main focus of our efforts and our investment and the weight of supporters that is disproportionately behind SUBLOCADE rather than PERSERIS, but we still have enough investment in PERSERIS to be able to drive the success of that product. So, we now have not only a clear vision and a strong presence in with our addiction sciences, we now also have a behavioral health sciences group. And what this means this is diversification, is additional revenue growth as well as a broader scope for our business development in the future. I'm not sure whether everyone is aware because sometimes you say, well, why -- what's the link between schizophrenia and substance abuse? Well, 50% not quite 50%, almost 50% of all schizophrenic patients are also diagnosed with a substance use disorder. So, if you look holistically at the patient, you actually see that there is a tremendous deal of overlap, not something we can leverage in the short term, but as we move forward and expand our understanding of these two patients and the relationships between those two diseases, an important growth opportunity. Geographically, we know that we are focused in our big priority growth market which is the U.S., but we haven't overlooked the opportunity to continue to expand our geographical global footprint, and as you know, we have sold the rights to our products in China. The idea is to shift the whole commercial enterprise and the risk to the Chinese company. It will take us probably till the end of the year, before that deal is fully executed. And I also want to make you aware that it is subject to a number of closing conditions. 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Here's the full transcript: Edited Transcript of INDV.L earnings conference call or presentation 14-Feb-19 11:30am GMT How can the company maintain the current headcount with generics launching this week? Second, we will launch an authorized generic to gain share of the generic market and preserve cash. With the potential for 3 or more generics launching, analogs indicate 78% to 80% off-branded price and 25% to 35% share of the generic market.
https://www.google.com/amp/s/www.bloomberg.com/amp/news/articles/2019-02-19/supreme-court-justice-refuses-to-block-generic-suboxone-film
It was lots of things, but today's news makes me really glad I left a few weeks ago. Losing Film is not good, especially with Sublocade continuing to struggle.
It was lots of things, but today's news makes me really glad I left a few weeks ago. Losing Film is not good, especially with Sublocade continuing to struggle.
It was lots of things, but today's news makes me really glad I left a few weeks ago. Losing Film is not good, especially with Sublocade continuing to struggle.
Whoever posted that transcript is dumb as dirt. Think it helps our situation for you to put company plans and goals out for all to see? Perhaps a lobotomy and shock treatment might do you some good, but I doubt it. I think you forgot..paybacks a bitch, numb skull.
OMG. The transcript is of a public call because you’re a public company. You, too, can read it. You have a college degree?
That transcript is public you moron....where do you think the poster got it from?? Almost all publicly traded companies do this.
I am not the poster but the transcripts are public information for investors...... the company purposely tells their plans. What a moron.
You are an absolute moron... This is all public information. Are you one of those CLs who does not have a single injection?
If its all so public, then what did you feel the need to post it here for, MORON? You idiots have way too much time on your hands. Quit and leave those who want to work behind. You're exactly the losers we're weeding out.
It's called transparency. Everyone is a stakeholder and should know what's going on..... Now go back into the field and try and get your first injection
12 million for Sublocade in 2018, are you kidding me! The Indians are coming to take your film market share, you should just get out of branded sales and be a generic company and have zero reps when you only sell $12 million. Company could probably do as well just having a mail-in sample request and e-mail promotion vs. paying rep over $100k to sell nothing, last one left please turn out the lights.
