Alkermes Plc (ALKS) Richard Pops on Q2 2016 Results - Earnings Call Transcript

| About: Alkermes plc (ALKS)

Alkermes plc (NASDAQ:ALKS)

Q2 2016 Earnings Conference Call

July 28, 2016 08:30 AM ET

Executives

Sandra Coombs - Director of Investor Relations

Richard Pops - Chairman and CEO

Jim Frates - SVP and CFO

Analysts

Jon Eckard - Barclays

Chris Shibutani - Cowen & Co.

Umer Raffat - Evercore ISI

Vamil Divan - Credit Suisse

Cory Kasimov - JPMorgan

Biren Amin - Jefferies & Company, Inc.

Operator

Good morning ladies and gentlemen, and thank you for standing by. Welcome to the Alkermes Conference Call to discuss the Company's Second Quarter Financial Results. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note that this conference is being recorded.

And I will now turn it over to Sandy Coombs, Director of Investor Relations at Alkermes. Sandy, you may begin.

Sandra Coombs

Welcome to the Alkermes Plc conference call to discuss our second quarter 2016 financial results. With me today are Richard Pops, our CEO; and Jim Frates, our CFO.

Before we begin, I encourage everyone to visit alkermes.com to find our press release and related financial tables, including a reconciliation of the GAAP to non-GAAP financial measures that we'll discuss today.

We believe the non-GAAP results better represent the ongoing economics of our business. Our discussions during this call will include forward-looking statements. Actual results could differ materially from these forward-looking statements. Please see our press release and 10-Q issued today and also our 10-K for the year ended December 31, 2015 for important risk factors that could cause our actual results to differ materially from those expressed or implied in the forward-looking statements. We undertake no obligation to update or revise the information provided on this call as a result of new information, future results or developments.

Today, Jim Frates will discuss our financial results; and Richard Pops will provide a brief update on the Company. After our remarks, we will open the call for Q&A.

Now, I'll turn the call over to Jim.

Jim Frates

Thanks Sandy. Good morning everyone. We're happy to report strong second quarter results, highlighted by the performance of our proprietary commercial products, VIVITROL and ARISTADA, as well as robust results from our royalty and manufacturing business.

Let me start with an overview of our financial highlights for the second quarter. We generated total revenues of $195.2 million, a 29% increase over the second quarter of 2015, a GAAP net loss of $47.2 million and a non-GAAP net loss of $1.6 million.

We are pleased with these solid results, which reflect the growth of end market sales of our diverse commercial portfolio, and also the timing of certain manufacturing shipments to partners.

Today we're increasing our financial expectations from 2016, driven by the performance of VIVITROL which continues to grow robustly and certain changes to our non-GAAP measures pursuant to guidelines recently issued by SEC.

In the quarter, VIVITROL net sales grew to $47.2 million compared to $37.2 million for the same period last year. We're continuing to see accelerating sales growth in both commercial sales and even more so in Medicaid sales driven by our focus on criminal justice programs and organic growth within the states. These programs broaden access to VIVITROL and expand our pool of patients and treatment providers, which we expect will ultimately lead to increased adoption of VIVITROL in both Medicaid and commercial settings.

VIVITROL is performing ahead of our projections and we now expect VIVITROL net sales to increase approximately 40% year-over-year for 2016, which is reflected in our updated financial expectations.

Turning to ARISTADA, our second-quarter net revenue of $10.3 million came in ahead of expectations. The launch is progressing as we work through the Medicare and Medicaid reimbursement cycle for a new product and ARISTADA is growing nicely in a long-acting injectable or LAI market that continues to grow at double-digit rates. That for us is the key at this stage.

The market is growing and our product attributes are becoming increasingly recognized in the field. Looking ahead, we expect the third-quarter ARISTADA net sales will be in the range of $13 million to $15 million.

Moving on to our royalty and manufacturing business. Overall, we recorded total revenue of $137 million, which included $69.6 million of revenue related to RISPERDAL CONSTA, INVEGA SUSTENNA and INVEGA TRINZA compared to $60.8 million in the same

During the quarter, we also recorded $40.8 million in revenue related to AMPYRA and FAMPYRA compared to $26.9 million for the same period last year. This higher-than-expected revenue was due to the timing of manufacturing shipments. And as a result, we expected our third-quarter revenues related to AMPYRA and FAMPYRA will be in the range of $15 million to $20 million. As we’ve seen before, while our manufacturing and royalty revenues for AMPYRA are lumpy in nature. The underlying growth trend in end market sales remained solid.

In terms of expenses, our total operating expenses for the second quarter of 2016 were $242.3 million compared to $203.9 million for the same period last year. This year-over-year increase in operating expenses was driven primarily by the launch of ARISTADA, including a full quarter of investment in the ARISTADA sales team, which was fully on boarded last year in June, as well as the growth of VIVITROL in the ongoing pivotal programs for ALKS 3831 and ALKS 8700.

With respect to our financial expectations for 2016, we're improving our guidance today to reflect the accelerating growth trend for VIVITROL and our increasing expectations for VIVITROL net sales by $10 million to a range of $190 million to $210 million and our expectation for total revenues to a range of $710 million to $760 million. This increase drives a $10 million improvement in our expectations for GAAP net loss, which we now expect to be in the range of $215 million to $245 million.

On a non-GAAP basis, our increased expectation from VIVITROL along with a $10 million adjustment related to the SEC's recent guidelines on non-GAAP measures, drives a $20 million improvement in our expectations for non-GAAP net loss, which we now expect to be in the range of $5 million to $35 million from our previous range of $25 million to $55 million. Our complete financial expectations for 2016 are outlined in our press release issued earlier this morning.

Taking a step back, our second quarter results demonstrate the ability of our business model to efficiently capture operating leverage as our topline growth. As we enter the second half of the year, we’re in a strong position financially to focus on accelerating the growth of VIVITROL and ARISTADA and advancing our proprietary pipeline of development candidates.

With that, I will turn the call over to Richard.

Richard Pops

That’s great. Thank you, Jim. Good morning everyone. Here at the midpoint of the year, Alkermes is strong, operating effectively, and according to our plans. Our commercial business is hitting its stride, generating significant revenues as VIVITROL and ARISTADA make exciting progress and our late stage pipeline continues to advance on multiple fronts.

We're building a company focused on addressing two of our country's major public health priorities, addiction and serious mental illness. These disease areas are characterized by stigmatized patient populations in broken treatment systems, further challenged by the reality that many of these patients are poorly positioned to advocate for themselves. These diseases have a disproportional impact on health care costs, on criminal justice system, and on long-term care.

This is where a biopharmaceutical company has the opportunity to shine and demonstrate the value that importantly medicines can bring to society. To address these challenges, we've evolved traditional pharmaceutical sales model into a dynamic, patient centric organization that incorporates policy, patient engagement, and economics into the daily execution of our strategy. These elements play a significant and increasingly important role in the treatment of mental illness and addiction. As an example, just last week President Obama signed into law a Comprehensive Addiction Recovery Act or CARA, following broad bipartisan support in Congress.

CARA is the first major piece of addiction legislation to pass in almost two decades, an emergence during an epidemic that has grown to claim a 129 lives a day in our country. CARA's passage is the culmination of efforts of a broad coalition of advocates that came together in support of the legislation and its implications are profound by empowering communities to respond and implement solutions and by strengthening the role the criminal justice systems will play.

CARA has the potential to radically change the way opioid dependence is addressed. In practice, this will be done through statutory changes complimented by funding initiatives. CARA includes provisions that reform opioid addiction treatment in several critically important ways. Office-based opioid treatment prescribers who are the buprenorphine prescribers are now required to be trained on and as lost states "provide directly or by referral, all drugs approved by the Food and Drug Administration for the treatment of opioid used disorder."

There are only three active agents approved by the FDA for the treatment of opioid dependence. As an opioid antagonist and the only medication approved for the prevention of relapse to opioid dependence, VIVITROL is uniquely positioned within this group of medicines.

The other key aspect of CARA is grant money. Grants will enable criminal justice organizations to implement treatment system in their communities, promote recovery, and help individuals lead drug-free lives. Against the backdrop of the current treatment landscape and a raging national epidemic, VIVITROL is beginning to experience robust growth. Yet still has only 1% to 2% market share in the treatment of opioid dependence.

VIVITROL was being incorporated into a rapidly growing number of state, counties, and municipality criminal justice system and healthcare systems. At last count, the number of programs in the states had expanded to more than 200, up from a 100 at the beginning of the year. These programs start small and they play an important role in broadening the utilization of VIVITROL in these communities.

Looking forward, you can see that the opportunity is significant, because the country is beginning to activate to address this serious epidemic. With this newly passed legislation, we are developing and implementing initiatives that build on CARA and have the potential to foster the long-term growth of VIVITROL ecosystems around the country.

Turning now to ARISTADA, during the second quarter, we made excellent progress in the ongoing nationwide launch. On a prescription basis, the LAI market grew 10% in the second quarter compared to last year. The aripiprazole share of the LAI market also continue to expand and ARISTADA contribute nearly half of the growth in the last quarter.

Importantly, our most recent data from the month of June showed that three quarters of ARISTADA starts came from patients on oral and psychotic medicines. This is what is fuelling the growth of the market. Converting patients from orals as physicians increasingly see the benefits of LAIs. Reimbursement and access are the focus of this launch year.

During the second quarter, we continue to make significant progress to secure parity access for ARISTADA on Medicare Part D and Medicaid formularies. As you’ve heard us say again and again over that past year, securing parity access for ARISTADA is a key priority for 2016.

In April, we reported that we’ve secured parity access for 3 of the top 10 Medicare Part D plans, 3 of the top 10 managed Medicaid plans and two thirds of state plans. I'm pleased to report that ARISTADA is now available at parity access at 5 of the top 10 Part D plans, 6 of the top 10 managed Medicaid plans and more than 80% of state plans.

Part D plans will also lock in their 2017 formularies over the summer and we expect to be well-positioned as those formularies are finalized and implemented next year. Our goal is to enter 2017 with ARISTADA essentially on the same playing field with the other long-acting injectable antipsychotics. Then we can compete on our merits which are explicit.

We are designing the ARISTADA product offering to be unique and characterized by its flexibility, providing options for patients, physicians and nurses. Beyond our current product offering for ARISTADA, which includes three doses and four and six week durations we're on track to submit the supplemental NDA in the second half of 2016 for the 1064 milligram two-month dose and we won't stop there. New product development continues and you will hear us describe other initiatives to expand the ARISTADA family.

Turning now to ALKS 3831, our novel, oral, broad-spectrum antipsychotic drug candidate for the treatment of schizophrenia. The pivotal program is well underway and will roll throughout 2016. As a reminder, the program consists of two core Phase 3 studies, ENLIGHTEN-1, evaluating the antipsychotic properties of ALKS 3831 placebo and ENLIGHTEN-2 evaluating weight gain compared to olanzapine.

In addition to the core pivotal study, we also plan to evaluate the metabolic parameters of ALKS 3831 in healthy volunteers. This study will build upon the exciting data we're generating preclinically, which are giving us greater insight into ALKS 3831 mechanism of action, both central and peripheral including its effect on mitigating the metabolic effects initiated or induced by olanzapine.

ALKS 8700 for the treatment of multiple sclerosis is also enrolling in its pivotal program. The pivotal program is straightforward. It consists of pharmacokinetic bridging data enabling a 505(b)(2) regulatory pathway referencing TECFIDERA and a two-year safety study. The PK bridging work is well underway and will include data from both fed and fasted studies.

The open-label safety study in approximately 600 patients with MS is on track enrolling as expected, because of the encouraging data we’ve observed in our early studies next year we also plan to begin an elective study to evaluate the GI tolerability of ALKS 8700 compared to TECFIDERA head-to-head in approximately 420 patients. We continue to complete -- expect to complete the studies required for registration and file the NDA in 2018.

Now onto 5461 for the treatment of depression. At the beginning of June, at the ASCP meeting, we shared with you and scientific community the full data set and study design details from FORWARD-3 and FORWARD-4. The totality of the data across studies show the consistent antidepressant profile of ALKS 5461, and also the challenge of controlling placebo response in depression studies. The replay of that webcast is available on our Web site.

Looking ahead, we're taking our learnings from FORWARD-3 and FORWARD-4 and made important adjustments to the third core efficacy study, FORWARD-5 for which we continue to expect topline data by year end. We also continue to advance our newer development candidates. We recently initiated the multiple ascending dose study for ALKS 7119 in Alzheimer’s agitation, based on encouraging data from the single ascending dose study. And ALKS 4230, our immuno-oncology candidate entered the clinic during the second quarter.

Let me close by saying that our business is operating in height year. Our teams are highly productive across an unprecedented number of pipeline programs and commercial activities. Our proprietary products VIVITROL and ARISTADA, are ramping up at a time when substance abuse and mental illness are in the public consciousness more than ever. Our pipeline of late stage product candidates is continuing to advance and we look ahead to important data readout in the coming months. We couldn't be more excited about the prospects ahead for Alkermes.

And with that, I will turn it back to Sandy for the Q&A.

Sandra Coombs

Great. Thank you. Brendan, we will now open the call for questions.

Question-and-Answer Session

Operator

Thank you. And we will now begin the question-and-answer session. [Operator Instructions] And from Barclays, we have Jon Eckard on line. Please go ahead.

Jon Eckard

Good morning. Thanks for taking the question. Congrats on the progress. I have a question on VIVITROL. So, you highlighted today 200 VIVITROL programs, Rich. If I’m not mistaken, the last update that you made was in the beginning of June, which was 150. This is a pretty meaningful jump in a short period of time. How are we supposed to -- how should we be looking at that number with regards to how it could play out with regards to growth of use of VIVITROL going forward?

Richard Pops

Good morning, Jon. I had a hunch you’d pick up on that number. Yes, it's quite remarkable, in fact, and I think a number of us as we prepared for the call is we went back to refresh that number, we’re surprised by how quickly that number has grown. And I think it's just indicative of a fact that there is a little bit of a propagation wave that's going across the country as Drug Courts, Criminal Justice Systems in particular adopt VIVITROL programs. As I said earlier, they start small as you know. But I think they’re just representative of fundamental tendency in the country now as embodies in CARA as well and as if people are getting upset with status quo. There is too many opioid death’s happening. When you hear 129 death’s a day in the country from opioid overdose. There’s a major problem here, and people are beginning to activate. So, I think that we’re going to continue to see that number grow. And I think those are basically -- we think of them as seeds that begin to bear fruit several quarters from now.

Jonathan Eckard

Okay. So with regards to, don’t look at this as a linear from a script perspective, but look at it as a beginning, and keep track of the growth of these …?

Richard Pops

Exactly. I think there is a true leading indicator of things that will trail some periods behind this. None of us really know precisely, how the correlation is. But we know that generally things are changing around the country in favor of the use of more VIVITROL.

Jonathan Eckard

A previously for VIVITROL you said I think it was either five or six states drove 50% of the -- of revenues for VIVITROL. Are you seeing a dilution or a spreading of that revenue? Or is that still fairly concentrated in those states?

Richard Pops

I’ll let Jim, give you more specifics, but it's still remarkably concentrated which also tells you we’re at the beginning of a more a general phenomenon. Jim, go you have any specifics?

Jim Frates

Yes. And the specific numbers actually are pretty much the same, Jon. They traded by basis points, not really by major percentages. So, five states are 48%, and six states are 52% or 53% of our growth. The one thing that is interesting too is, those states are -- our largest states are growing the fastest, and that to me just again reiterates how early we are in this growth curve. We have more states to expand into as the pilot programs extend. And even the states where VIVITROL is selling, where we’re selling the most VIVITROL are continuing to expand at the fastest rate. So again, we’re just early in the growth curve here as people figure out how to use, implement and adopt VIVITROL in their treatment paradigm.

Jonathan Eckard

Great. I’ll get back in the queue. Let other people ask questions. Thank you very much.

Jim Frates

You are welcome, Jon.

Operator

From Cowen & Company, we have Chris Shibutani on line. Please go ahead.

Chris Shibutani

Thank you. Congrats on the progress as well. Keeping the topic on VIVITROL which is guiding your raised guidance. And a little bit more granular, you talked about how the largest states are driving. You’ve talked previously about core providers. Can you update us on what you think that core provider number is? And also what you think the mix is in terms of institutional versus community? And then finally in terms of the core providers, what are you seeing in terms of the ability to extend the number of doses per patient, and the number of patients those core providers are treating? Those must be trends that I would imagine are helping contribute why your strong states are growing the fastest? Thank you.

Jim Frates

Yes, Chris, good question. And we do track those numbers. We obviously have to make some estimates about the exact number of injections that physicians are using per patient, that sort of a thing. But we’re focused now on, and we see about 1500 doctors which is an increase of core provider, and they’re using about 75% of our sales -- our scripts. And so that growth is positive and broadening that provider base is something that we are very focused on. We’re also beginning to see a change in improvement on duration of therapy. A year ago in March we talked about little over three months duration of therapy and that seems to be ticking up, the average might be around four months now. Again those numbers are done by surveys by us and we do that in debt kind of once a year. So we’ll update more clearly on that as we move through the year. But all the trends in VIVITROL as we see it are positive. We’re getting broader number of providers. We’re going deeper in the providers that are using VIVITROL. And we’re really seeing, as Rich has said before these are kind of one way valves. When people start using VIVITROL and they understand the right sort of patient to use it for, they tend not to stop using VIVITROL at least in our experience today.

Chris Shibutani

And with the co-providers can you give us a rough breakout between the community versus the institutional?

Jim Frates

Yes, I mean that's a harder number to come by I think -- and I think, just because it's such a disjointed treatment provider system. But I know of area of providers in both the large nationally known institutions are that, that are adopting VIVITROL more widely, but also the single individual programs that are associated with smaller community hospitals and community programs. So, I would say that growth is pretty even across the board and we’re seeing growth in each of those areas.

Chris Shibutani

Thank you.

Jim Frates

You are welcome.

Operator

From Evercore ISI we have Umer Raffat on line. Please go ahead.

Umer Raffat

Hi, guys. Thanks for taking my questions. I have a few here. First, Richard you said you’ve made important adjustments to FORWARD-5. Just wanted to understand, what exactly is this new updated statistical plan, and how will the endpoint be measured? Secondly, the 8700 head-to-head trial versus TECFIDERA, so that's delayed onto 2017. I just wanted to understand the thought process behind that. What happened to make you guys things have pushed down six months? Third, so the fumarate’s open-label trial is ongoing for 8700, and I just wanted to understand what are you seeing early on, on GI tolerability in that two year safety trials, because you presumably have a decent amount of patients enrolled and you’re getting a good amount of data open-label on that. And then finally, I noticed there was a PK trial for a 3831 initiated in June. I wasn’t quite sure of why that happened for a drug in Phase 3. So I just want to understand the rational there. Thank you.

Richard Pops

Good morning, Umer. Had the coffee this morning, didn’t we? So I’ll take those in sequence. So, FORWARD-5 as of -- and we’ve said it number of times, we will not disclose the specific statistical plan because of the fact that the study is ongoing and we don’t want to change placebo response but people understand the analytical method that we’re going to use. But you’ve heard us talk about before that, the reasons why we might have missed on FORWARD-3 and FORWARD-4, and how we can integrate other statistical methodologies to more accurately model the difference between the curves if it exists. So we’ll kind of stick with that. And so, like I’ve always said, just don’t try to anticipate FORWARD-5, let it play-out and see how it looks. And we shall be sceptical until such time as we get the data and we can look at it. 8700, the head-to-head comparison with tech because it wasn’t originally on the critical path for registration because we moved the safety study has always said that we’ll file this drug in 2018. I think we’re running something like 70 clinical trials at Alkermes this year. So it was one that we could shift as we had this thing stacking up in the regulatory and clinical operations queue. With that said though, the question you asked about the open-label is absolutely true. We are enrolling patients in the open-label study and without giving you specifics; I’ll just say we’re very pleased with the profile of 8700. It's quite consistent with what we’ve seen historically. So all systems are go on that and we’re quite excited to run the head-to-head comparison with TECFIDERA. And ultimately integrate that into the product profile, because we think it's an important part of the drug. The 3831 PK study, I’m not even really aware. We have a whole bunch of clinical pharm studies that’s running around the context of a pivotal program. So there’s nothing -- there’s nothing particularly exciting about that. Sandy, I don’t know if you have more detail on that?

Sandra Coombs

No, just that. That’s the standard.

Richard Pops

Okay. It's some PK -- we can look into it Umer, but it's anything particularly exciting.

Umer Raffat

Got it. But just to be clear, Richard. Do you still think 8700 is differentiated versus TECFIDERA on GI based on everything you’re seeing so far?

Richard Pops

I do -- I do. And again, we always said it was the caveat that we -- that’s why we run experiments. We want to make sure, but that's why the definitive study will be when we go head-to-head. But we’re really pleased with what we’re seeing so far. As we accumulate more data, our confidence in that continues to build. So that in a controlled study will give us the answer.

Umer Raffat

Got it. Thank you very much.

Richard Pops

You are welcome.

Operator

From Credit Suisse we have Vamil Divan on line. Please go ahead.

Vamil Divan

Great. Thanks so much for taking my questions. So, just two here. One on VIVITROL, go back to that one, obviously very good volume growth. Can you give a little more color around the pricing side of that and maybe sort of a level of net pricing you’re receiving for that product? And then my second one, just on 5461, have you had any further sort of direct discussions with the FDA since you gave us a lot of subject just back in the June timeframe. And any other thoughts that they have in terms of the changes you’ve made to FORWARD-5? Thanks.

Jim Frates

Sure. Just on VIVITROL -- Vamil, good morning. Gross to net did increase this quarter as we saw Medicaid growth year-over-year actually over a 150%, and commercial growth over -- well over 30%. So the product is growing very, very nicely. Our gross to net for VIVITROL are now in the high-40s up from 40% in Q1. And again we’re predicting that slow increase over time, but it is going to start to moderate that growth obviously as Medicaid becomes a larger proportion of overall sales. The impact on the pricing will diminish over time. And so, I think VIVITROL growth is going extremely well and we’re very, very pleased with where we’re headed there. Rich?

Richard Pops

On the 5461, we as I said before, we’ll submit the statistical plan to FDA before we unblind obviously, and we’ll have interactions with the FDA on the stat plan at that point. But we probably won't update on FDA interactions other than that.

Vamil Divan

Okay. Thank you.

Richard Pops

You are welcome.

Operator

From JPMorgan, we have Cory Kasimov on line. Please go ahead.

Cory Kasimov

Hi. Good morning, guys. Thanks for taking the questions. First of all, I wanted to follow-up on those core five or six states for VIVITROL, and learning’s that you can glean from them that can perhaps be applied to other states. Really kind of curious how their pilot programs evolved over time, and maybe how long it took to work through the process, which I assume is going to continue to gain momentum if there is more of a ground swell support for this initiative now? And then I have a follow-up.

Richard Pops

Yes, Corey, if you look at those leading states, leading edge is the Ohio and Massachusetts, in particular, it really is a story about building an ecosystem in the state on a county-by-county basis. Even Ohio for example with 80 some odd counties is still not firing on all counties. Right now, there’s probably 10 or so counties. Jim, will tell you that, that is driving 50% of the sales. So it's about local treatment systems and integrating with the Criminal Justice System and the Drug Courts along with state based appropriations and behavioral changes that lead to, linking in with detoxification capabilities, there’s just a lot of different elements. And if you could come here and walk into to the war room what you’d see is basically a profile of the entire nation of the states that are at that leading edge already. The ones that we think are on deck to become those next states. The ones that are a little bit behind that and the ones that are just getting out of the starting blocks, and so we have a whole staged approach to maturing these states. We don’t drive at all. Well I know a lot of it has to happen within the state itself. But we have a pretty good sense now of the activation level of various states across the country.

Cory Kasimov

Okay, great. And then, my second question is a follow-up to what Umer asked about the head-to-head with TECFIDERA being pushed out to 2017. How much of that has to do with just kind of waiting to see how the TECFIDERA IP situation plays out?

Richard Pops

Zero.

Cory Kasimov

Okay. All right, perfect. Thank you.

Richard Pops

This is just a question of, this place is so busy. I mean, even it takes 10 minutes for me to go through a summary of all the wastage pipeline programs. We have so many studies going on, and it's so active around here, and we just have to sometimes -- sometimes you just have to prioritize. And we try to -- we’ve had so much going on and that study is a relatively straight forward study, and so we pushed it out a bit.

Cory Kasimov

Got it. All right. Thanks, Rich.

Sandra Coombs

Okay. We have time for one more question.

Operator

And from Jefferies we have Biren Amin on line. Please go ahead.

Biren Amin

Yes. Thanks for fitting me in guys. Just on the VIVITROL guidance for the year. Are you assuming any price increases in the second half?

Jim Frates

No, we’re not Biren. We haven’t taken a price increase this year, and that's not part of the assumption at this stage.

Biren Amin

Okay. And then just on the CARA Act. What initiatives are you going to start that takes advantage of the CARA Act. And I guess I’m just trying to get some color around the Suboxone clinics. How many Suboxone clinics currently to your knowledge do not prescribe VIVITROL?

Richard Pops

I would say, for the purpose of this conversation, no Suboxone clinics prescribe VIVITROL, these what are called OBOTs, the Office Based Opioid Treatment, there are OBOT docs. There’s something like 30,000 certified OBOT docs, I wish, but I think probably about half are active about 15,000 OBOT docs, and they really are Suboxone providers. And so, I think post CARA you can think about it in two simple domains. One is, what are we going to do to make the law reality and that all treatment providers need to be trained on all FDA medicines. So that's one opportunity. Then the second major opportunity is within Criminal Justice itself, because CARA elevates the role of Criminal Justice providers in the treatment, in the community to be central on the treatment of this opioid epidemic. And VIVITROL is uniquely suited for use in the Criminal Justice system, because it's non-divertible and has no street value. So we have a particularly advantage position in the Criminal Justice world as well. So we’ll be working initiatives on both sides of that opportunity.

Biren Amin

So just a follow-up on the Suboxone clinics. Do you plan or do you think that you would need sales force expansion to cover these clinics adequately?

Richard Pops

At the moment, we don’t. But we are contemplating putting a kind of a new team of people into various communities where the ecosystem is mature to help drive a change like that post CARA. But we’ll keep you posted on that. We’re just evolving those, that thinking right now within the Company.

Biren Amin

Great. Thank you.

Richard Pops

You are welcome.

Sandra Coombs

Great. Thanks everyone for joining us on the call today. If you have any additional questions, don't hesitate to reach out to us at the Company. Thank you.

Operator

Thank you. And ladies and gentlemen, this concludes today's conference. Thank you for joining. You may now disconnect.

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