Sandra Coombs - Director of Investor Relations Richard Pops - Chairman and CEO Jim Frates - SVP and CFO.

Cory Kasimov - JPMorgan Chris Shibutani - Cowen & Company Umer Raffat - Evercore ISI Biren Amin - Jefferies Terence Flynn - Goldman Sachs.

Good morning and welcome to the Alkermes Plc Third Quarter 2016 Financial Results. 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 this conference is being recorded. And I will now turn it over to Sandra Coombs.

You may begin..

Welcome to the Alkermes Plc conference call to discuss our financial results for the quarter ended September 30, 2016. With me today are Richard Pops, our CEO; and Jim Frates, our CFO.

Before we begin, I encourage everyone to go to the Investors section of 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.

In conjunction with our GAAP results, we believe the non-GAAP financial 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 revise the information provided on this call as a result of new information or future results or developments. Today, Jim Frates will discuss our financial results, and Richard Pops will provide an update on the company. After our remarks, we’ll open the call for Q&A. Now, I’ll turn the call over to Jim..

Thanks, Sandy. Good morning everyone. The positive results for ALKS 5461 have dominated our recent news and we're excited to be back on track with that program. The strength of our business model is its diversity and opportunity for operating leverage and we're seeing that play out in our results.

We're on plan with our revenues growing and our non-GAAP net loss narrowing year-over-year. In the third quarter, we generated total revenues of $180.2 million, an 18% increase over the third quarter of 2015. And we reported a GAAP net loss of $62.7 million and a non-GAAP net loss of $14.1 million.

These solid results were driven by the growth of our proprietary commercial products and notably the continued emergence of VIVITROL as it begins to make an impact in the treatment of opioid dependence.

On that point, as most of you know, at the end of September we hosted an investor event focused on VIVITROL to provide new information that is useful in understanding the complexities and opportunities in the addiction treatment landscape, and the recent growth trends for VIVITROL.

During the quarter, VIVITROL net sales grew to $55.8 million, compared to $37.9 million for the same period last year. These results reflect 47% growth in net sales and 66% growth in unit’s year-over-year. Gross to nets improved slightly versus last quarter, mainly reflecting quarter to quarter fluctuation of the timing of State Medicaid rebates.

We continue to see strong growth in both Medicaid and Commercial segment. During the third quarter, Medicaid accounted for approximately 45% of our total VIVITROL units sold, reflecting organic growth within the states and criminal justice program. VIVITROL net sales have grown at a compounded annual growth rate of 39% in recent years.

Even with this robust growth VIVITROL's market share is only 1% to 2% of the drug treated opioid dependence market and there remain significant opportunity ahead.

With the opioid epidemic worsening, and the passage of the Comprehensive Addiction and Recovery Act or CARA, this summer, there are many reasons to believe that the growth of VIVITROL will remain strong. Let's turn to ARISTADA which we see joining VIVITROL as another major driver of our long-term growth.

The launch is progressing as planned and in the third quarter we generated net sales of $14 million, the midpoint of the expectation that we provided on our Q2 call in July. On a prescription basis the overall atypical LAI market grew 10.2%.

The aripiprazole share of the atypical LAI market also continued to expand with ARISTADA contributing 42% of growth in the last quarter. Looking ahead, we expect that fourth quarter ARISTADA net sales will be in the range of $16 million to $19 million. Moving on to our royalty and manufacturing business.

Overall, we recorded total revenue of $110.2 million which included $73.3 million of revenues related to RISPERDAL CONSTA, INVEGA SUSTENNA and INVEGA TRINZA, compared to $67.6 million for the same period last year, driven by strong growth of INVEGA SUSTENNA and INVEGA TRINZA.

During the quarter we also recorded $12.9 million in revenue related to AMPYRA and FAMPYRA compared to $22.1 million for the same period last year, reflecting the timing of manufacturing shipments. While our manufacturing and royalty revenues for AMPYRA are lumpy quarter-to-quarter the underlying growth trend in and end market sales remained solid.

So during the third-quarter revenue grew by 18% year-over-year and with disciplined cost management operating expenses grew by only 5% to $241.4 million. This solid results demonstrate our operating leverage as we grow our proprietary commercial portfolio.

Based on these results we are reiterating our financial expectations for 2016 which we provided on July 28th. Turning to our balance sheet we're in a strong position and into the third quarter with $624.6 million of cash in total investments.

In September we repaid $60 million of our debt at its maturity and in October we extended the maturities of our remaining $286 million of debt by two years to September 2021 at the same interest rate the underlying trends of our business are strong and evident in our results.

We continue to capture important operating leverage as our top line grows and we take advantage of our efficient operating structure. As we approach year-end we're in a strong financial position as our commercial business accelerates driven by the growth of VIVITROL and ARISTADA.

Our pipeline of late stage product candidates is advancing, and we're preparing for our next commercial opportunities. With that, I'll turn the call over to Richard..

That's great. Thank you, Jim. Good morning everyone. While this was an excellent quarter in an exciting past couple weeks and as we approach the end of 2016 the future potential of Alkermes is coming more clearly into focus, VIVITROL and ARISTADA are continuing on their growth trajectories.

ALKS 8700 and ALKS 3831 are well into their pivotal studies and following the positive results from forward five study two weeks ago we're already preparing for a meeting with FDA and our planned NDA submission for ALKS 5461, we are building a major biopharmaceutical company here.

Let me start briefly with VIVITROL, which as Jim mentioned was a subject of a deep dive presentation in late September.

I recommend you take a look at the archived webcast if you're interested in learning more about this remarkable medicine, which is getting its legs at last and growing into a really significant medicine for this company and ultimately we believe for the country.

The addiction treatment ecosystem in which we operate is unique and incredibly fragmented. In order to foster adoption of VIVITROL, you've head us describe the three critical elements.

First, a broad provider network capable of addressing local patient needs that incorporates detox and medications to treatment and that fosters continuity of care in the community.

Second, favorable access and reimbursement, by that we mean not only will payers reimbursed for the patrol but barrier such as prior authorization and fail first requirements are eliminated and third favorable policy environment where government officials are focused on the opioid epidemic with funding available for treatment and a criminal justice system that’s motivated to move from incarceration to treatment.

In order to address these unique and complex challenges, we've established equally unique commercial approach and organization, and the trends speak for themselves.

Looking ahead to further support the increasing use of VIVITROL, we continue to develop new tools to assist physicians in transitioning their patients from opioid dependence to initiation of treatment of VIVITROL.

Our phase 3 study of ALKS 6428 is has completed enrollment and we continue to expect data in the first half of 2017 Turning now to ARISTADA. During the third quarter we made excellent progress in the ongoing nationwide launch.

Our key priority for the ARISTADA launch in 2016 was working through the process to secure favorable access and reimbursement on a state-by-state and plan-by-plan basis. We are carefully and successfully executing that plan.

ARISTADA is now available at parity access on six of the 10 - of the top 10 Medicare Part D plan, six of the top 10 managed Medicaid plans and 80% of state plans. We expect to pick up a few more Part D plans this quarter as we finalize contracts for the 2017 formularies.

These successes we've had in terms of access and reimbursement will take full effect in 2017, when we expect to be essentially at parity access with the other long acting atypicals.

This will mark the beginning of the second stage of the ARISTADA launch, where access and reimbursement are better established and ARISTADA can compete in a marketplace on its merits which are quite clear. Beyond our current offering, our work to expand the ARISTADA products family continues.

We submitted the sNDA for the two-month 1064 dose of ARISTADA in August and it was recently accepted for filing by FDA with a PDUFA in June 2017. And we look forward to bringing this additional option to market, expanding ARISTADA offering of doses in durations to allow physicians to provide highly individualized treatment plans for their patients.

We've also made important progress in the development pipeline. Two weeks ago we announced positive Phase 3 results from FORWARD-5 for ALKS 5461 for the adjunctive treatment of major depressive disorder.

ALKS 5461 represents a new mechanism of action in a treatment landscape dominate by SSRIs and SNRIs which fail to provide a relief to more than 5 million patients in the US with major depressive disorder, a disease that can be fatal without effective treatment.

FORWARD-5 was a double-blind placebo-controlled study that evaluated the safety, tolerability and efficacy of two dose levels of ALKS 5461 in 407 subjects. The efficacy results from FORWARD-5 were clear and positive. The safety results were equally important.

With potential use in millions of patients, we believe the safety profile ALKS 5461 will be one of its most meaningful attributes. In FORWARD-5 we had a very high completion rate of 83%. 5461 was generally well tolerated and the most common adverse events were nausea, dizziness and fatigue.

These events are generally mild, transient and typically occurred around the time of treatment initiation. So, the results from FORWARD-5 are clear and robust. And importantly, the study does not stand alone.

We've amassed an extensive data set that encompasses more than 14 clinical trials, data for more than 1,500 subjects who participated in the 5461 clinical efficacy program and 1,500 patients who've enrolled in the long-term safety study nearly 600 of whom have already completed 12 months of treatment.

But perhaps most striking about ALKS 5461 is the consistency and the totality of the data in terms of antidepressive effects as well as its safety profile.

So we believe that the positive FORWARD-5 study taken together with the confirmatory results from our randomized control Phase II study, the support of data from the FORWARD-4 study that we reported earlier this year and data from the collective 5461 clinical program provides substantial evidence of efficacy in support of a regulatory submission.

With the results of FORWARD-5 now in hand we are preparing our NDA submission for this fast-track designate medicine and we've request a meeting with FDA to review the data from the entire FORWARD program. We expect that meeting to occur in the first quarter of 2017.

So turning out to ALKS 3831, our novel, oral broad-spectrum, antipsychotic drug candidate for the treatment of schizophrenia. The pivotal program is up and running with most trial sites now online and several months of enrollment experience under our belt.

ENLIGHTEN-1, the four-week Phase III study evaluating the antipsychotic properties of ALKS 3831 versus placebo and ENLIGHTEN-2, the six-month Phase III study evaluating weight gain compared to olanzapine are both well underway. We will provide an update on expected timing for the studies as we get a bit more resolution early in 2017.

During the third quarter, we initiated a metabolic study that will give us a greater insight into ALKS 3831's mechanism of action, including its effect on mitigating the metabolic effects induced by olanzapine. We expect data from this study in the first half of 2017.

ALKS 8700 for the treatment of multiple sclerosis is also enrolling in its pivotal program. The pivotal program consists of pharmacokinetic bridging data enabling a 505(b)(2) regulatory pathway referencing TECFIDERA and a two-year safety study. We expect to complete the PK bridging work by year end.

The open label safety study in approximately 600 patients with MS is on track and rolling as expected.

The preliminary data from the open label study are encouraging and we look forward to initiating an elective study in the first half of next year to evaluate the GI tolerability of ALKS 8700 compared to TECFIDERA head-to-head in approximately 420 patients.

We continue to expect to complete the studies required for registration and file the NDA in 2018. Moving now to ALKS 7119, which reminds us that not everything always goes according to plan. Just in the past few days we made a decision to terminate further development, about 7119.

Following the positive results from the single ascending dose study earlier this year, we initiated the multiple ascending dose study in healthy volunteers in that study, we began to see unacceptable side effects.

These were mild in nature and result in a small number of patients that were affected they were not observed in the single ascending dose study nor predicted based on preclinical, however initial analysis does suggest their drug-related and dose-dependent.

Given the elderly population affected by Alzheimer's agitation, we establish at the outset that excellent, tolerability was a critical performance factor 7119 is not living up to that standard. So were done.

I want to thank the teams that work so hard on this program and the clinical researchers and volunteers who participated in the studies okay to finish up.

We are at an unprecedented place in Alkermes evolution, with two proprietary products growing in the market, a potential blockbuster product in ALKS 5461 advancing again at full speed and two additional late stage candidates well into their pivotal programs.

We're right where we want to be well-positioned for near and long-term growth and well on our way to building a major biopharmaceutical company With that, I'll turn it back over to Sandy for the Q&A..

Thanks we'll open the call for Q&A now..

Thank you. We will now begin the question-and-answer session. [Operator Instruction] And from JPMorgan we have Cory Kasimov. Please go ahead, sir..

Hey. Good morning, guys and thanks for taking the questions. One on VIVITROL, another on Maintaina [ph] or maintain ARISTADA competition.

So VIVITROL first, just regarding utilization on the state level, can you talk about the progress that's been made on getting beyond those five or six core states that you've referenced in the past and kind of when we can expect to see others moving into that group. And then I have the others ARISTADA..

Hey, Cory. It’s Rich. I won't give you absolute specifics on because I really don't want to track this on the quarter by quarter basis, state-by-state because some of this actually pretty confidential information.

But with that said, we're just reviewing some additional states yesterday as a matter fact and yes, there are those that are moving left or right on that graph we showed you and beginning to move into the category of a highly developed ecosystem where we expect to drive more utilization.

So just suffice to say that, it’s progressing and I think it’s going to continue to progress quarter by quarter..

Okay.

And then, with regards to ARISTADA and given your kind of poise to be operating now at parity with the competition, how do you look at the share - the kind of the study climate maintain or share that I now believe is up to like 16% or 17% of the overall LAI market? Does that kind of give you added confidence in the potential of ARISTADA given that I believe you said in your prepared comments that that product contributed, I think it was 42% of the overall aripiprazole growth in the quarter?.

So I think that there's a real opportunity in the marketplace for a long acting aripiprazole formulation and Maintaina being the first has the opportunity to kind of get there and demonstrate that. But I think with the features that we have with ARISTADA we're incredibly well-positioned for the long-term.

So I think the two fundamental things are happening. Number one, you've seen it from the charts that you've generated and we've provided. The overall growth in the LAO market is continuing to grow. And from a public policy point of view, we can - we really see that that's a trend that should continue in the U.S.

The treatment of schizophrenia is so fragmented and so poor that there's a real opportunity for more utilization of long-acting injectables in general. Within that, I think that the aripiprazole itself has a very favorable profile, particularly for early initiation of patients and earlier in their disease.

And within the aripiprazole formulations you’ve heard us say of course that we think that ARISTADA has the market-leading features. So we've been working for years to get to the point where we can compete equally. We’ll move into 2017 essentially at parity with the other LAIs.

And as I said earlier that marks the beginning of Phase 2 of the launch, really..

Okay.

And then, just as a follow-up to that, when you look - what are you learning from the TRINZA launch in terms of the markets desire for even longer acting therapies?.

Well, it's a great question and again it’s really underscores our excitement about the June PDUFA date for the two-month that we have. I think that you've heard us said along that the existence of TRINZA or the existence of our two-month is not that the whole market is shifting to longer durations.

And we're still trying to get the world to shift to the use of LAIs in general. But when you're choosing among LAIs, it gives you an additional level of flexibility for your patient if you're a physician. Because you can say, should my patient do well on this medication and be adherent, we can minimize the number of injections per year.

So we think that this flexibility in dosing is really important advantage on the competitive basis..

Okay. Appreciate the color. Thank you..

You’re welcome..

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

Yes. Thank you. Two questions. One related to VIVITROL, Jim, I believe you provide some metrics which has helped us to model, talking about average duration of use and average net pricing. If you could perhaps provide some update on what the trends are during the quarter that will be helpful, and then I have a follow-up on 5461..

Yes. Hi, Chris. Good morning. Yeah, we really have - obviously we gave the deep dive in September at our analysts call with both, the Analyst Day which both Rich and I mentioned. And I think from a duration perspective we are still seeing that in the four-month range for VIVITROL.

I think we are seeing positive trends there as we continue to grow that that divesting steady. But not a whole lot of update here 30 days later there. On the price side, we actually had a relatively good quarter.

It was slightly more positive than the previous quarter with our average net selling price of little bit over $700 this month, and I think that really just relates to the fluctuation we talked about is the timing of various State Medicaid rebates come through.

You know I think the modeling exercise that we did in September had us using prices between $600 and $700 for the long-term, so an average its $650. You know, we just saw a quarter slightly above $700. So I think we are very comfortable with those averages long-term.

And I think it underscores really what's happening with VIVITROL as that growth in units is accelerating. We are still very low market penetration, again, as both Rich and I mentioned and unfortunately this problem is only getting worse in the country as we see day-to-day continued headlines about the opioid crisis getting worse.

And VIVITROL's knowledge and people's experience with it is growing and so we're looking forward to protracted period of growth here with VIVITROL..

Thanks. And on 5461, so the statistical analysis that you did was a revised in FORWARD-5. When we will be able to see that data and in particular you commented that when you apply that form analysis to FORWARD-4 that you were able to also get capable type of results.

Can you give us a sense for when we will be able to see the details on that statistical analysis? And then also with 5461, I believe the combination of the buprenorphine with the samidorphan has the potential quality of addressing the addictive properties of buprenorphine.

Can you give us some sense for when we will be able to get a better understanding of that aspect of 5461's profile? Thank you..

Sure Chris. We're looking right now at what the most appropriate meeting for presentation would be, it's likely not to be until the spring. But we're working on that real-time. Our probably most important - most immediate audience is obviously with FDA as we start putting together the plans for filing the NDA.

Indeed when we - when you look at the statistical analysis planned that it was changed for FORWARD-5 it's actually fairly straightforward and I think most of you had predicted it which is instead of relying on a single time point for the analysis of the change from placebo, we've looked at an average of multiple time points to give us a more correct description of the separation of two curves.

And when you apply that same analysis to FORWARD-5 to FORWARD-4 it very easily become a very positive study. The other thing is interesting and I think it's a separate point but because FORWARD-4 and FORWARD-5 are essentially designed to denigrate we can pool the results of those two studies.

And that's where you start see even larger ample sizes in each of the analytics cell and you start getting even stronger statistical significance, albeit it’s as a post-doc but pre-specified pooling that we put in place.

So as I said earlier, I think the robustness of the data, the consistency of the data is what so striking any single study can be informative, but when you put them altogether that’s where I think the power of the 56461 dataset lies.

I think that the buprenorphine, samidorphan in combination its original design intent was to do just what you suggest, it’s too ablate or remove the addictive potential of buprenorphine, buprenorphine at 2 milligrams is not a drug with pace, physicians would feel comfortable administering to patients for the treatment of depression because of its addictive potential.

In fact buprenorphine widespread use in the community is something that we were living with as we as we deal with VIVITROL and the opioid. So it's an essential component of 546 on to the samidorphan component that ternate the addictive potential of the opioid.

So we have data that support that and it comes in a number different ways, one is the more directly we look at that will become human abuse potential or HAP study, which we completed last year, we gave the top line data on that, we're not yet presented that, I we will.

The other thing is just in the context of testing 1500 patients, you look at things like withdrawal, if there is any withdrawal indication where people come off of 5461 series not, we look at whether there is any AAE associated to you for your other opioid like effects which are not.

We also look for even more subtle or maybe less subtle, explicitly like to patients refused to return their drug at the end of the study, the drug get diverted within the context of the study.

These are all part of what FDA called their eight factor analysis that helps them determine the scheduling liability or potential of a particular medicine all those things now this isn’t theoretical anymore, we have a lot of data over a lot of patients over a lot of time and so we're really excited about that aspect of this medicine..

Thanks. We'll be watching for the up spring meeting. Thank you..

You're welcome..

From Leerink Partners we have Paul Matteis. Please go ahead..

Hi. This is Jeffery Lays, on for Paul Matteis. Thanks for taking my question and congratulation with the future growth in third quarter.

So on 5461 as you prepare you’re your FDA meeting, could you perhaps give us a little bit of - I guess, as you go into the meeting, what are your expectations in regards to the - what do you expect to receive from the FDA in terms of the approvability of your data package? And would you consider running another current Phase 3 as you are preparing for your NDA filing? And a follow-up question after this..

Yeah. Our presumption right now is we're going to go ahead and file the NDA for 5461 based on a substantial amount of evidence that we develop through multiple clinical trials. So, really our meeting with FDA is to review the data from the entire forward package and talk about our regulatory approach. It is a fast track designating medicine.

We've had multiple conversations with FDA about this medicine along the way. And we really consider it to be part of an ongoing update on our registration pathway for ALKS 5461. As it relate to another study, I think that we believe that 5461 is going to be a really important product.

And so we’re starting the adjuvant setting in patients with inadequate clinical response to SSRIs or SNRIs. But I don't think it stops there. And so, we certainly will be running additional studies overtime in different indications and different patient subsets.

But I think for the purpose of initial registration we feel like we have an adequate data set. But, right now, we're actually planning next studies of 5461 as we think about it becoming an important product over the next many years..

Okay. Thanks for the color.

And also I know it wasn't mentioned on this call, but could you possibly give us a little bit of insight on the status of your IL-2 program and when do you expect to see data from it?.

Yeah. That's 4230 and we're enrolling in the dose escalation phase, so the first phase of our first program. So we'll escalate for the next several months and then we’ll move into an expansion phase if we see the type of profile that we expect to see and hope to see. So it's still early days..

All right. Thank you very much..

You're welcome..

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

Hi, guys. Thank you for taking my question. Richard, would you initiate a new trial on 5461 while the FDA review is ongoing? Sort of like what Shire did with Xiidra when it wasn't clear if they will get an approval based on their existing data, but the drug appeared to be active.

And then also, perhaps just to ask, perhaps to Elliot, so FORWARD-5, is it [indiscernible] at week five as in the same endpoint as - as in if it were to be the same primarily endpoint as FORWARD-4.

And then finally on 8700, I'm just curious any feedback from the open-label to your safety trial as well as, we noticed you guys added some European sites in there, so just wanted to understand the thought process. Thank you..

Good morning. We are actually discussing whether we will initiate additional studies on 5461 while we are going and part of it is just bandwidth. We have a lot to do on 5461. We're really excited about it.

We think it's going to be really important drug that has potential to be used in a range of different patients other than patient simply adjunctive in major depressive disorder. So we're kind of digesting the data right now and figuring our next moves.

I wouldn't look to us to initiate a study as an insurance policy because we are not confident in the data - from the program as we currently have it configured. But will try to ask and answer probably a different question scientifically because we felt we've really done a pretty good job of interrogating the use of it in the first approval setting.

The 8700, yes, it's an open label study with 600 patients, so we need a lot of sites and we want to include sites from all over and we’re actually reviewing the AE data on open label basis, so it’s quite encouraging.

So the weakness of that observation, of courses, is that there is no comparator, so we're looking forward to stating that head-to-head comparison. But nothing we've seen so far has diminished our original hypothesis that we have opportunity to differentiate, so we look forward to doing that in 2017..

And the FORWARD-5 on week-five?.

We haven't disclosed anything other than we disclosed in the press release in terms of the further analyses of the efficacy. But I think you can pick and join time points and see significance.

But I think our whole point is that individual time points aren’t really the most correct way to look at this, because of the week-to-week fluctuations that you see. So we’re really convinced that the most appropriate analytical method is to look at the separation occurred by averaging multiple points..

Thank you very much..

You're very welcome..

From Jefferies, we have Biren Amin on line. Please go ahead..

Yeah. Thanks guys for taking my questions. Just maybe just start with VIVITROL. The guidance - I guess full year guidance when you back out everything that you've reported suggest a slightly down Q4.

Is that just the company being conservative or do you expect Q4 to be impacted by rebates or I guess will holidays impact administration schedules? Just like to get a….

Yeah. Hi, Biren. No, we don’t expect a down Q4. I mean, if you look at the totality of guidance which was 190 to 210 and denied that we could've raised the bottom end of the guidance is to make that clear.

But you were definitely expecting growth of VIVITROL in the next quarter and rather than updating the bottom end of one part of our guidance we decided, we let people look at the trends of VIVITROL and make that conclusion. So now were definitely expecting continued growth,.

Got it. And then just on ARISTADA, I think Richard you mention in the second stage of launch in 2017 with reimbursement and access coming online.

Do you expect to anticipate increase in sales force numbers in '17 or do you feel that your fully staffed?.

I think we're good about where we are on the commercial side. So I think the other element of the second stage of the launch of course would be to approval for two-month in the summertime. So I think we've got not only the access selling itself out.

We've got a good team in place and we also have the adrenaline shot of another dosage form coming to market, so I think we're feeling real good about it..

Great. Thanks for taking my call..

You're welcome..

I think we have time for one more question..

Thank you. And from Goldman Sachs, we have Terence Flynn on line. Please go ahead..

Hi, Thanks for taking the questions. Maybe just two from me.

Rich is wondering if you can confirm if you had any communication with FDA yet following the FORWARD-5 data and then Jim as we think about R&D heading into 2017, just given the completion of the 5461 phase 3 program now is it fair to assume there's some downward pressure on this line that is on the first of as the normal metaphors.

So Terence on the first - as a normal amount of course we send FDA that the press release on the day of the announcement primarily beforehand and will be following up with a formal meeting request in the next couple weeks or so. So that's that the itinerary actions right..

Good morning, Terence and on the R&D spend, your right 5461 is winding down this year you know, I think the opportunity for us is that actually three 831 or 8700 or moving into a broader phase 3 program.

So you know, think that we will guide right today for '17, we're doing our budgets now, but as we wind down one phase 3 program were winding up two and I think the value of our pipeline is evident to a lot of folks and next year you'll see a lot of focus I think on 3831 and 8700 as well, even as we success in our commercial business and with 5461.

So we feel like were fitting on all cylinders and we certainly have the financial resources to manage all those programs. So we'll give you more guidance when we update for next year, but at least some trends to think about..

Okay. Thanks a lot..

You're welcome..

Thank you. We will not it back to Sandy Coombs for closing remarks..

Thanks everyone for joining us on the call this morning and if you have any follow up questions we'll be available at the company for the rest of the day. Thank you..

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