Alkermes Plc. (NASDAQ:ALKS) Q1 2016 Results Earnings Conference Call April 28, 2016 8:30 AM ET
Sandra Coombs - Director of Investor Relations
Richard Pops - Chairman and Chief Executive Officer
Jim Frates - Senior Vice President and Chief Financial Officer
Vamil Divan - Credit Suisse
Cory Kasimov - JPMorgan
Jon Eckard - Barclays
Paul Matteis - Leerink
Biren Amin - Jefferies
Good morning and welcome to the Alkermes Plc First Quarter 2016 Financial Results Conference. My name is Brandon, and I'll be your operator for today. 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 Sandra Coombs, Director of Investor Relations at Alkermes. Please go ahead.
Good morning. Welcome to the Alkermes Plc conference call to discuss our financial first quarter 2016 financial results. With me today are Richard Pops, our Chief Executive Officer; and Jim Frates, our Chief Financial Officer.
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 conference 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 to revise the information provided on this call as a result of new information, future results or developments.
Today, Jim Frates will then 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.
Thanks Sandy. Good morning everyone. We're happy to report solid first quarter results. Our base royalty and manufacturing business performed well and as we expected.
On top of that foundation, our commercial products VIVITROL and ARISTADA are in phases of significant growth and will be the key drivers of top-line in the coming years.
This quarter results was also marked by steady investment in our late stage pipeline and reflects launch spending on ARISTADA, where you can begin to see as the opportunity ahead.
As our proprietary products grow our topline significantly and we leverage our efficient infrastructure. As our commercial products grow and our late stage pipeline comes to market. We had significant operating leverage in our business in the years ahead.
Let me start with an overview of our key financial highlights for the first quarter. We generated total revenues of a $156.8 million, the 10% increase over last year when we exclude our divested Gainesville business.
For the quarter we recorded a $24.6 million non-GAAP net loss, these results are also inline with our financial expectations for 2016 and reflect the investments we're making this year in Phase 3 portfolio and the launch of ARISTADA.
The key driver of our financial performance during the quarter was VIVITROL, our novel once monthly injectable product for the treatment of opioid and alcohol dependence.
In the quarter, VIVITROL had net sales of $43.8 million, compared to $31.1 million for the same period last year, demonstrating growth of 41%. On a sequential quarter basis net sales grew 15%. We're seeing growth in both the commercial business and in the Medicaid business.
Over the last 12 months the contribution of Medicaid sales to our VIVITROL revenues doubled to approximately 30% and continues to grow. We think this is great news because the majority of patients with addiction are not covered by commercial health plans, and the expansion to Medicaid and other state programs is beginning to contribute more significantly to VIVITROL's growth.
This growth in our Medicaid sales has been fuelled by policy advances and criminal justice programs design to address opioid addiction. In the last few quarters we've began to experienced organic growth in state and federal programs, as the positive results being generated in pilot programs in one area are recognized and replicated in others.
We saw another prime example of this organic growth last month when the results of a VIVITROL criminal justice study were featured in the New England Journal of Medicine. Also notable is that this large study in more than 300 individuals in the crime justice system was independently conceived and funded by NIDA and conducted by third party addiction expertise, a leading academic medical centers in the country.
We believe the recognition of the opioid crisis and VIVITROL's results in one of the prominent medical journals is assigned that our product is facilitating an important medial need in the unique and complying way.
We see the growth of VIVITROL in the criminal justice system is a leading indicator of VIVITROL's potential in communities nation-wide. As these programs continue to product complying results the network of VIVITROL providers in these communities is expanding. We believe we are just at the beginning of this growth curve.
To give you a sense of how early we are 50% of our VIVITROL net sales in 2015 came from only six states. As experience with VIVITROL expanse to the country it's clear that we have a significant opportunity ahead of us.
Turning to ARISTADA, we're now in our six month post-launch an ARISTADA continues to perform as planned. We're off to a solid start with $5.5 million of net sales during the first quarter.
Looking ahead, we expect the Q2 net sales will be in the range of $7 million to $9 million. We'll provide more specific net sales guidance for the full year as we gain further experience with the launch.
As we've said before, this market is Medicare and Medicaid market and it will take full calendar year for us to gain broad access. Rich will provide some more color on the launch, but we're well on our way.
Moving on to our key partner products, we saw overall revenues of $93.4 million in first quarter compared to $93.2 million in the first quarter of last year. This included manufacturing of royalty revenues of $54.7 million related to RISPERDALCONSTA, INVEGA SUSTENNA and INVEGA TRINZA compared to $46.9 million for the same period last year.
In terms of expenses, our total operating expenses for the first quarter of 2016 were $233.7 million compared to approximately $188.5 million for the same period last year.
This increase year-over-year on operating expenses was driven primarily by ongoing pivotal programs for ALKS 3831 and ALKS 8700 and ALKS 5461, as well as the investment in the launch of ARISTADA and in the growth of VIVITROL.
As note, during the quarter we entered into collaboration with reset therapeutics related to that novel orexin modulators which may have utility in a variety of CNS disorders.
Alkermes has made an upfront payment of $10 million that we recorded as R&D expense and the reset we'll use to fund their clinical development through initial Phase 2 studies.
We also made $15 million preferred equity investment in reset. This collaboration with the company that had deep expertise in orexin modulators enhances our development portfolio and provides the new long term opportunity for us in CNS.
Turning to our balance sheet, we're in a strong position and ended the first quarter of 2016 with $719.4 million in cash in total investments. Our cash used during the quarter included the $25 million investment in our collaboration with reset and capital expenditures of approximately $12 million related to investment in our manufacturing capabilities to prepare for commercialization of our late stage pipeline candidates.
As of March 31, we had $348.5 million of debt, roughly $60 million of which is due in September of this year with the reaming balance due in 2019. Operationally with three pivotal development programs underway and the ongoing launch of ARISTADA 2016 is the year of investment. However our topline is poised for significant growth.
Going forward is VIVITROL continues to accelerate and as the launch of ARISTADA progresses. We will have significant operating leverage positioning the company for return to profitability and earnings growth.
The financial underpinnings of our business are strong as ever and we look forward to building Alkermes into a premier growing in profitable leader in CNS medicines.
With that, I'll turn the call back over to Richard.
That's great. Thank you, Jim. The strength and resilience of the business we build became very evident this past quarter. The here and now of the business, the foundational base of manufacturing and royalty revenues coupled with VIVITROL and ARISTADA represents an unusual and compelling growth story from products that received FDA approval and are growing as key players in important markets.
When you add on top of that are highly diversified pipeline of CNS candidate, anyone of which could gap our evaluation significantly, the upside of this company is as clear as ever been.
As we move into the remainder of the year, we'll be entering a catalyst rich period for the pipeline and we expect to see exciting growth of VIVITROL and the launch of ARISTADA continue to build momentum.
Jim cover the existing progress of VIVITROL earlier, but I just want to give you a sense of how we see the grounds as well as support for VIVITROL building through some of the statistics regarding media coverage throughout the country during just the first quarter.
400 media pieces, print articles, broadcast segments and radio segments on VIVITROL have appeared in 39 states so far in 2016. This is more than three times the number of stories and nearly double the number of states compared to Q1 of last year.
We exceeded 1 billion estimate media impressions in Q1, a fourfold increase from Q1, 2015. The absolute numbers and the growth rates well, they speak for themselves. They are important because the ultimate size of VIVITROL opportunity will be determine to a great extent by public awareness of the existence of a different criminal alternative for a serious epidemic. This is beginning to happen around the country and it's exciting to absorb.
Turning to ARISTADA, the nation-wide launch is in full swing, and we're encouraged by our early results in schizophrenia market. The long-acting injectable or LAI market continues to grow at double-digit rate.
On a prescription basis, the overall LAI class grew 14% in the first quarter compared to last year, importantly the aripiprazole share of the LAI market also continue to expand, with ARISTADA contributing nearly half of the growth in the last quarter.
Our team with 175 territory business managers is targeting a well-defined group of physicians who have the history of prescribing LAI's for the treatment of schizophrenia.
We've distributed more than 14,500 samples since launch to help physicians gain experience with ARISTADA and to encourage early use while accessing reimbursement established around the country.
We're beginning to see the returns on this investment as 100s of physicians who have initiated treatment with samples are converting now to prescribers. Regarding the reimbursement you'll recall that approximately 90% of our business will be with government payers namely Medicare and Medicaid.
During the first quarter we conducted dozens of reimbursement meetings and we're pleased with the progress that we're making. ARISTADA is now available on most Medicare Part D and managed Medicaid formularies including the Top 10 in both categories.
Initially, in almost all these cases this access is subject to pre-authorizations which requires providers to seek approval prior to the prescription being covered. Our next priority is to improve access to parity with other LAI and we're well in our way.
To-date three of the Top 10 Medicare Part D plans and three of the Top 10 managed Medicaid plans and about two-thirds of state plans have grant ARISTADA parity access and we expect several more decisions in the next couple of months.
Overall, this process is advancing and we will continue to work through the formulary process of each individual plans throughout the remainder of the year. As more plans get turned on our expectation is that growth will accelerate into the backend of the year.
ARISTADA embodies key attributes, important to patients and healthcare providers, efficacy, flexibility with a range of doses and durations and a simply ready-to-use format. Physician’s feedback has been consistent with this and it's encouraging.
Interestingly in the very early weeks of the launch, while many of the ARISTADA new starts came from oral antipsychotics as expected, we also saw a significant fraction coming from other long-acting atypical products and were for 882 milligram dose, which indicated some unsatisfied needs in the market.
In the past few weeks, this has evolved to a nearly two-thirds of ARISTADA starts are coming from patients on orals and approximately half of the prescriptions are at 882 milligrams. As the launch continues and the clinicians gained more experience with ARISTADA, we expect that the percentage of scripts coming from orals will continue to increase, which further expands the LAI market and the distribution among the range of ARISTADA doses will become more evenly weighted.
Beyond the currently approved doses, durations and indications, earlier this year we announced positive results of a potential two-month dosing regimen of ARISTADA and based on these results, we plan to submit a supplemental NDA in the second half of 2016 for a 1,064 milligram dose which will expand our current offering to four doses and three dosing intervals, four week, six weeks and eight weeks. And we are going to stop there.
We will continue to invest in ARISTADA and we are building the product to be the market leader with an unprecedented range of doses durations and multiple indications. It’s an important medicine in a rapidly growing U.S. market and we look forward to updating you on our progress forward.
When we turn to our news this morning, we continue to develop compelling new medicines from our R&D engine. ALKS 7119, our novel chemical entity for the treatment of Alzheimer’s agitation and other psychiatric indications entered the clinic in January. While still early in development, we are excited about the potential of this candidate in a disease area with a compelling unmet medical need in the growing area of Alzheimer’s disease.
In our market research, we found physician response overwhelming, indicating that agitation and psychiatric symptoms that can accompany Alzheimer’s disease with a leading source of morbidity and caregiver burden. We are pleased to report today that based on the preliminary findings for the single ascending dose study of 7119, we’ve accelerated the decision to advance into a multiple ascending dose study.
The early results of the single ascending study demonstrate a favorable tolerability profile and pharmacokinetic properties consistent with the potential for once a day dosing. The study is still underway and full data is expected in the second half of this year. We are excited to be advancing 7119 forward and plan to begin the multiple ascending dose study in volunteers in the third quarter and expect results from that study around year end.
Okay, now onto 5461 in depression. As most of you know by now, we are proceeding with the Phase 3 program and we are building a strong foundation knowledge of the clinical activity of ALKS 5461. We are looking forward to sharing the data from FORWARD-3 and FORWARD-4 with you and the scientific community at the ASCP or American Society of Clinical Psychopharmacology meeting at the beginning of June. And we will host a webcast conference call for investors to discuss the data. We’ve taken all of our learnings from FORWARD-3 and FORWARD-4 and made important adjustments to FORWARD-5 to increase the probability of a positive outcome. With that said the people I have told you since January. While we are confident in the antidepressant properties of 5461, we’ve learned that the outcome of any single study is difficult to predict due to the variability of placebo response.
To be clear though if FORWARD-5 is positive, we will meet with FDA and discuss the plan to file the NDA for this fast track medicine. In the scenario, our robust data package would include a positive FORWARD-5 along with positive results from the randomized placebo controlled Phase 2 study, together with support of evidence from FORWARD-4, data from FORWARD-3 and FORWARD-1 and other clinical pharmacology studies from pivotal program.
So, operationally, we’ve not changed our approach. That’s the plan. We will have a much better sense of our next steps after FORWARD-5 reads out, which we continue to expect in the fourth quarter of 2016.
Turning now to ALKS 3831, our novel, oral, broad-spectrum antipsychotic drug candidate for the treatment of schizophrenia. Both of the core studies in the Phase 3 program are now underway. In ENLIGHTEN-1, a four week efficacy study, evaluating the antipsychotic properties of ALKS 3831 in approximately 390 patients with acute schizophrenia and in ENLIGHTEN-2, evaluating weight gain compared to olanzapine in approximately 540 patients over six months.
Size initiation is well underway and enrollment will continue through 2016. As we did with the FORWARD program, we will update you on our progress and our estimated completion window as we get further runway and gain more experience with the enrollment trends. In addition to the core pivotal studies, we will begin the study evaluating metabolic parameters of ALKS 3831 later in the year. This is an area of deep interest and we are conducting extensive preclinical work and getting an understanding of ALKS 3831’s role in mitigating olanzapine metabolic effects.
Also enrolling in a pivotal program is ALKS 8700 for the treatment of multiple sclerosis. ALKS 8700 is an oral molecule that’s designed to rapidly and efficiently convert to monomethyl fumarate or MMF in the body and offer differentiated features as compared to TECFIDERA, a drug generating approximately $4 billion a year in annual revenues.
In the fourth quarter of 2015, we announced that initial data demonstrated that ALKS 8700 met the pharmacokinetic criteria for bridging to TECFIDERA, enabling a 505(b)(2) regulatory pathway referencing TECFIDERA. We are now completing the pharmacokinetic bridging work, which will include both fed and fasted studies and we will announce the data from those studies in the coming months.
In addition to the PK bridging data, the pivotal program will include a two-year safety study in approximately 600 patients with MS, which is currently underway. This is a substantial study that we would enroll across 135 sites in the U.S. and abroad. We are on track with our expectations at bringing those sites on board and we currently have 30 sites open for enrollment.
From a commercial perspective, we are very interested in determining the competitive profile of ALKS 8700, so we are electing to conduct that randomized head-to-head gastrointestinal tolerability study of ALKS 8700 compared to TECFIDERA in approximately 420 patients that we plan to begin in mid 2016.
Lastly, for our immuno-oncology candidate, we submitted the IND application in March and we plan to initiate a dose escalation study in multiple tumor types in the coming weeks. So, in summary, with VIVITROL, ARISTADA, three drug candidates in pivotal studies and two new candidates beginning clinical trials, the medical importance and potential economic value of our business has never been stronger.
We should have an exciting remainder of the year and we will look forward to updating you. And with that I will turn it back over to Sandy for questions.
Thank you. Brendon, will you please open the line for questions.
Thank you, Sandy. [Operator Instructions] And from Credit Suisse we have Vamil Divan. Please go ahead.
Yeah. Great. Thanks so much for taking the questions. I have one question on 5461. You mentioned the ASCP meeting in June and I’m just curious the decision to present that data before FORWARD-5 is completed and maybe you can just talk through why getting it up with that in anyway, maybe risk impacts and the placebo effect you might see in FORWARD-5? So if you could just discuss why presenting the numbers later would be helpful?
Good morning, Vamil. No, it’s a good question. As you know, mitigating placebo response is a central design feature of this study. We made the decision really for two reasons. One is that we feel like the enrollment and much of it in lies phase of FORWARD-5 will be substantially complete by that time.
And we don’t expect a lot of media coverage of that particular meeting. The second is that FDA attends that meeting and has historically and it’s a really good venue for the community to get together and review data. And we’ve heard from our key opinion leaders that it is quite important that we keep educating the committee as to the viability of 5461 because as you know, we feel very strongly of this drug is advancing in development and we want to make sure that the community understands the progress that we are making.
Okay. So, you know with the fast track designation, I guess more they get in the community will help with their discussion with the FDA on that front because I’m afraid with fast track you are having the discussions with the FDA without having to present the data publically.
Well, I think that it’s a very small community actually, particularly those involved in the clinical research we are in, in our antidepressant products. And we have a lot to do with this drug over time and we really believe this whole new area, this mechanism of opioid modulation for the treatment of new disorders is a different way of treating the disease and we need to continue to build the kind of the scientific, academic foundation of support for this approach. So this is a major program. It’s been ongoing for years. We’ve been updating this community consistently over the years and it is business as usual so we are going to keep going.
Okay. And then just one more on ARISTADA if I could and then I will drop off. Just, I guess the comments you made around uptick so far on the payer side, is there any more color you can just provide on the success you’ve had and you said you will kind of keep updating as for the course of the year but we get a lot of questions on sort of anymore details you could provide where you have had wins and kind of when we could expect more from that? Thanks.
Well, let me try to give you some sense of where we stand with respect to Medicare Part D, management acada [ph], whatnot and so it’s important. Think of it in two stages. First stage is getting access at all, which we’ve been quite successful in the first quarter as I mentioned. Many of that first stage of access is still subject to prior authorizations.
So then in stage 2, then is to move into parity access with other LAIs and we read about 3 of 10 of the major programs and many of the plans are preparing for the 2017 formulary by submissions that happen in the next few weeks. So there is a lot going on as we move into the early part of the summer to kind of prepare the index for 2017.
So, even as we get wins in 2016, sometimes it doesn’t drive formulary behaviour until as we move into 2017. That’s why we’ve always set along. It takes about a year to get on but I’d say it’s just steady progress and each month, we will turn over more cards and we expect to exit the year in a very good position.
Okay. Thank you.
From JPMorgan we have Cory Kasimov. Please go ahead.
Hey. Good morning, guys. Thanks for taking the questions. So, Rich, first on VIVITROL, just curious how much are you able to do on your end to help further accelerate the adoption of state programs, or is this something that you kind of sit there and support and enable but kind of needs to kind of play out by itself?
Good morning, Cory. We are so fast and of course in 10 years to be an overnight success with VIVITROL. We’ve been doing the step for six years now on the opioid side and lay the foundation for that. So, we can do a lot. So, when we actually makes the plane take off the runway after lumbering down for long time is the fact that as Jim mentioned in his remarks, it starts to become a little bit organic that other jurisdictions see what’s happening and they begin to start pushing for implementation of VIVITROL programs on their own without our help.
As you further say, we are in 100 programs in 30 states but Jim will correct me. I think there is something on the other 3,100 counties in America. So, when you think of the denominator being at 3,100 and the numerator being a 100, we are just getting going. So there is no way we can from a personal point of view, blank at 3,100 counties in America, what happens is that it becomes self propagating. So that’s what exciting. So to answer your question is we can do a lot but in doing a lot the ideas that is actually there is a multiplier effect.
Okay. All right. That’s interesting. And then just one other big picture question. We’ve been talking about your relatively big balance sheet and potential BD opportunities for while you had the deal you talked about a little bit, a little update this morning. Are you starting to see more opportunities though in the emerging CNS space and do you think that the opportunities in maybe 2016 are better than they have been for you in the last couple of years? Obviously, you’ve had the downtick in valuations but just more on the emerging platform and new candidate side?
I think there is more activity in the earlier development of CNS compounds that would be of interest to us. But I wouldn’t go so far to say is that it’s a target rich environment. It’s still selective. A lot of stuff that we see is the derivative of prior development programs and we really don’t have any interest in repurpose molecules or things that are shades of the same color what already exist. So, I think to gain reimbursement and access and pricing and all of things you’ve heard us talk about over the years, as we think about our business through the perspective of the four pillars, we really need highly differentiated medicines. And I think there is a growth in those opportunities but it’s always going to be very selective.
Okay. All right. Makes sense. Crazy earning days. So, I will stop there and hop back in the queue. Thanks a lot, Rich.
From Barclays, we have Jon Eckard. Please go ahead.
Good morning. Thanks for taking my questions. So on ARISTADA, I think you made a comment that you are seeing a lot of diversions from other allied long-acting injectables and you also said that you are seeing more conversions of physicians who converting patients from samples to -- from samples to commercial products. And I think the number of samples went up at least 4,000, I think from the last update. Going forward, what metrics can we look for on an ongoing basis maybe to there could be an indication that you are getting more of these conversions from commercial to from a commercial to you know from free product to commercial products. And then I have a question on VIVITROL.
Good morning, John. I think the simplest thing is just wash his grips and so we are doing this for a reason. And obviously the sampling intensity will decline as we gain more and more access. This is really a way to get physician’s experience with the drug and while access is still difficult across the country. And the sampling program has -- it’s not a one to one. Every sample we give does not convert into prescriptioners, inherent kind of uncertainty in the whole thing.
But so far we are really pleased with what we’ve done and to put that number into perspective, I think we said 14, 500 samples is against the backdrop of selling on the order of 500 or so samples a week. So we’ve put a lot of product out there for people and we think that people getting experience with the product hands on, the flexibility, the ease of use and what not is really, really playing a strong foundation for accelerated growth on the back end of the year.
But ultimately the only thing that matters is the prescription trends as the plane takes off the runway.
Great. And then on VIVITROL if I heard it right, I thought it was a really interesting statistic that 50% of sales from [Indiscernible] if I heard it right. And again I’ve been monitoring a lot of these -- the vast number of VIVITROL related news events and you know programs that are up in coming. Is there also an effective way that we can track overtime between quarters on how or new VIVITROL programs is there some kind of centralized place for you where people are -- where these are being announced or we can follow them, so we can track them….
There really isn’t o -- unfortunately John there really isn’t and the most prudent way of doing is just by attracting in Google alerts or whatever you are looking at VIVITROL and what you’ll see is just an amazing amount of coverage about the price, some of that coverage includes activities in state and county jurisdiction where they will be funding more other measures to facilitate the use or fund the use of VIVITROL, but we haven’t put together a central repository of it yet.
And then in Washington you know President Obama has been quite vocal about the need to increase treatment, [Indiscernible] treatment for opioid addiction. What about on the congressional front? I believe there’s been something that a bill had passed through the Senate but still waiting for Congress, I mean, can you give us an update on anything that might be in the works done in Washington to help improve access for these products.
Yes there’s two major -- two or three different legislative routes that VIVITROL is deeply embedded in. The one you referred to the comprehensive addiction recovery act is a piece of bipartisan, by camera [ph] legislation focussed on a number of different approaches addressing the opioid epidemic in the country. And there is some provisions in there, they are very favourable to VIVITROL, that depending on the existence of floor time over the next few weeks, we think there is a high probability that, that because of the broad support that that bill to get passed.
In the judiciary side, of course the criminal adjusted system we have interest in facilitating more programs that focused on non addictive medications like VIVITROL being the central one in the Criminal Justice System which has not been historically got amendable to the use of methadone or Suboxone.
And the third and just in basic -- the basic blocking attack on your appropriations and on those funding each year, we saw last year the first funding that directly applied to VIVITROL and we expect that continue going forward. So it’s really -- it’s a dual pronged approached from a policy point of view. At the federal level as you know that really augments what’s happening at the state level, but ultimately the federal allocations get pulled through in the form of grants to states. So it’s important that the states be prepared and ready to implement VIVITROL programs and to tap into that funding. So we’ve been working at both levels from multiple years.
Perfect. I’ll get back in the queue [Indiscernible] other questions. Thank you. Good luck.
Thank you, John.
From Leerink, we have Paul Matteis on line, please go ahead.
Great. Thanks guys, appreciate it. I have a couple of questions, my first is on ALKS 3831, I was wondering if you could run through a little bit more detail on the two Phase 3 designs I know one of these has a co-primary endpoint. It seems clinical trials.gov and then based on that what kind of labelling language you are hoping to attain relative to Zyprexa.
Morning, Paul. Yes, the two studies, the first study which is the acute study versus the primary comparison is ALKS 3831 versus placebo in a four and five week acute setting looking and demonstrating its clear antipsychotic properties, and of course that's a fairly straightforward, 130 patients per ARM, we're running a olanzapine arm in that as well, just although we not powered for non-inferiority just to have that data point because payers will be interested in that as well.
And as you know, we've shown non-inferiority olanzapine in our previous large Randomize Phase 2 study. That's call Enlightened 1. So that's up and running. Enlightened 2 is the weight study and Enlighten 2 as you say has co-primary endpoint but they co-vary that's why it's not that really different. We're looking at what we showed in phase 2 which is A, a change in median weight change from baseline compare of ALKS 3831 versus the control arm which is olanzapine in this case.
And the second is been as you shift that curb to percentage of patients who the categorical cut of patients who have greater than 10% body weight. And we, as you saw, we saw a strong correlation between those two statistical parameters in Phase 2 and I think both are important, like both were in terms of labelling, because as you know some of the early responses to our Phase 2 that where you saw mean change of the certain number of pounds or certain percent people will say, what's the trivial amount, even though they doesn't -- without recognizing it represent, it’s a profound shift in a curb, as you shift the curb, those tails go down significantly, so that categorical cut at 10% which you could say is really clinically meaningful cut is also really important. And we expect both of those to be in the label, because they are the primary endpoint of one of the pivotal studies.
Okay. Thanks. That's helpful. And maybe a follow-up on that, Rich, shat doses of a olanzapine are you comparing 3831 to. And maybe to put in a context, how does that compare to the dose that was use in the KD study?
We have flux dosing on the olanzapine, so we're co-formulating multiple olanzapine doses with 10 milligrams of samidorphan.
Okay. And for olanzapine arm in the trial?
Yes. So the [Indiscernible] dose is high there were and we expect to median dosing to be between I'm guessing 10 and 20 milligrams, and I think will compared favourable to what we saw in KD [ph].
Okay. Got it. And then maybe just one follow-up on the BD deal for the orexin modulators. There's been others in development. I think J&J has one. Maybe can you speak to just what about this technology stuck out here and what's interesting and what indications you plan on positioning this mechanism and going forward?
Yes. We like the biology. We like the company really, really scientifically excellent and working on both positive, negative allosteric modulators of the orexin receptors. We have probably the most proximate clinical utility of that you would think immediately with respect to orexin is in narcolepsy, but there is a range of things not all which we're going to disclose. But we've got some time. We're doing chemistry. We're working on lead identification, but it’s a fine group of scientists and we're excited about the collaboration.
Okay, great. And I hope you don't mind, I just want one quick follow-up on 3831, I realized I miss one of my questions. On these two main studies what are you looking at with respect to metabolic syndrome, I know you're doing a separate study for that, but in the two lead studies what are you examining there?
I'm not exactly sure of all of those various chemistries. We look at the – basically the rule we're looking lipids and probably glucose and simple things like that. Although in a long six months study in patients who has schizophrenia, that's not the right setting if we're looking at metabolic parameters that's why we're going to go, drill down in a much more intense way doing what we're doing in the animals and try to replicate in the human, because we're finding some really, really important finding with respect to what olanzapine is doing to trigger metabolic changes in the periphery and also help 3831 or samidorphan component of 3831 is a nearly rating and mitigating those effects.
So, we're quite excited about that and as I've mentioned we'll ask together its probably one of the largest preclinical scientific programs within the company, because we think the story of 3831 is far more than just about an ameliorating weight, its effect on weight is derivative of a more fundamental effect on metabolic changes in the organism.
Okay. Do you plan to presenting preclinical data some times?
Absolutely. We're publishing and we're presenting, although I wouldn't expect anything on that until the fall at least.
Okay. Great. Thanks Rich.
I think we have time for one more question.
From Jefferies we have Biren Amin on the line. Please go ahead.
Yes. Thanks for taking my question. Rich maybe I'll just start with FORWARD-5, have you discuss the changes in the study design with FDA? And also would you think company needs to hit in terms of P value. Would you need to like less than 0.01 to support a strong case for FDA approval?
No, not at all, so FORWARD-5 will present the data and ASCP as I mentioned were from FORWARD-3 and FORWARD-4, we'll submit the statistical analysis plan to FDA for FORWARD-5 normal course sometime before we unblind. But the operational changes that we may or making within the program really don't required FDA interaction. They are quite straightforward and they're just based on learning and adapting from what we saw in FORWARD-3 and FORWARD-4.
With respect to P value I think [Indiscernible] is the ticket into this discussion, because what you'll see is that -- remember when we're talking about statistical separation for placebo in these types of clinical trials its against the backdrop of placebo response is quite powerful even in study designs where you mitigate placebo response. So, statistical separation from placebo is the most important thing.
Then of course you go into the various sub-group analysis in teasing a part where you see more accentuated evidence of efficacy. But I think that it's not just a question of P value per say, it's about robustness and consistency of the data. For example, if you want to achieve a P value based on a single time point that you happened to chose as your primary endpoint, but the rest of the time points were not significant has much difference than seeing continuous drug effect over an extended phase of the clinical trial. So I think it's too simplistic to focus simply on P value but just know the [Indiscernible] is what you need.
Okay. And then question on 6428 when we get data from this trial and do you expect the data would be label enabling for VIVITROL? And would you expect that this data would give you some leverage with especially the government's effort in tackle opioid addiction?
So 6428 is for those who don't know, it’s a very kind of elegant taper kit based on very small doses of naltrexone to enable people to transition from opioid agonist treatment to VIVITROL recognizing the people need to be detoxified from opioid before you can initiate with VIVITROL. So it's basically think of like Z pack [ph], it’s a series of daily dose of increasing levels and decreasing levels of naltrexone and opioids.
We expect data from the first study in Q1 of 2017, Sandy Tells me. And we think this is just part of as VIVITROL gets more and traction around the country. We start expanding the shelves of physicians who are interested in using VIVITROL. In the beginning we didn't need a taper kit, because the only doctors that are using VIVITROL quite expertise in detoxifying patients.
As more and more doctors get trained and more and more people interested in VIVITROL a simple you would have though that there is an established protocol for transition from opioid in the communities but there really isn't.
And so, 6428 is part of the tool kit to help more and physicians to be able to transfer transition patients offer low opioids on the VIVITROL. So we think we'll have a good effect but part of another brick in the wall as we build the foundations for VIVITROL.
Great. Thanks for taking my question.
Thank you, Biren.
Great. Thank you everyone for joining us on the call today. If you have any questions, please don't hesitate to call [Indiscernible] company. Thank you.
Ladies and gentlemen, this concludes today's conference. Thank you for joining. You may now disconnect.
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