Alkermes, plc (NASDAQ:ALKS)
F3Q 2013 Earnings Call
January 31, 2013 8:30 am ET
Rebecca Peterson - SVP, Corporate Communications
Richard Pops - CEO
Shane Cooke - President
Jim Frates - CFO
Cory Kasimov - JPMorgan
Steve Byrne - Bank of America
David Risinger - Morgan Stanley
Catherine Arnold - Credit Suisse
Jon Eckard - Citi
Anant Padmanabhan - Cowen & Company
Ami Fadia - UBS
Mario Corso - Mizuho USA
Corey Davis - Jefferies
Terence Flynn - Goldman Sachs
Ladies and gentlemen, thank you for standing by. Welcome to the Alkermes plc Conference Call to discuss the company's Third Quarter Fiscal 2013 Financial Results. At this time, all participants are in a listen-only mode. There will be a question-and-answer session to follow. Please be advised that this call is being recorded at Alkermes request.
At this time, I would like to introduce your host for today's call Ms. Rebecca Peterson, Senior Vice President of Corporate Communications at Alkermes. Please go ahead.
Good morning. Welcome to the Alkermes plc conference call to discuss our financial results for the third quarter of fiscal year 2013, which ended on December 31st, 2012. With me today are Richard Pops, our CEO; Shane Cooke, our President; and Jim Frates, our CFO.
Before we begin today, let me remind you that we will make forward-looking statements relating to, among other things, our expectations concerning the commercialization of our products, our future financial expectations and business performance, and our expectations concerning the therapeutic value of our clinical development products. Listeners are cautioned that these forward-looking statements are neither promises nor guarantee and are subject to a high degree of risk and uncertainty.
Our press release issued today, our Annual Report on Form 10-K with the SEC and our other filings with the SEC identify risk factors that could cause our actual performance to differ materially from those projected or suggested 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.
This morning, Jim Frates will discuss our third quarter financial results, and Richard Pops will provide a brief update on the company. After our remarks, we'll open up the call for Q&A.
Now I'd like to turn over the call to Jim.
Thanks, Rebecca. Good morning, everyone. We are pleased to report another quarter of strong financial results, driven by robust operational performance across the business. From a broader perspective it's now been more than a year since the merger. This is the first quarter we can see the true organic growth that this business can generate. We're very optimistic about the future and today we're improving our financial expectations for fiscal 2013.
First, let me start with a review of the results for our fiscal third quarter. We recorded total revenues of $135.9 million representing an increase of 8.2% over the third quarter of last fiscal year. This growth was given primarily by our key commercial products, which together grew 33% year-over-year. The revenues from our key commercial products accounted for nearly 70% of total revenues during the quarter compared to 55% during the third quarter of last year. This increasing percentage is exactly what we predicted as our key commercial products continue to ramp and the legacy product revenues diminish.
Now, let me highlight the performance of the key products driving our growth. Our long-acting atypical franchise, RISPERDAL CONSTA and INVEGA SUSTENNA, continue to be the most significant contributor to our results during the quarter. End-market sales for RISPERDAL CONSTA and INVEGA SUSTENNA were approximately $586 million. Year-over-year, the combined franchise grew approximately 13% on a dollar basis and, as Johnson & Johnson reported last week, achieved operational growth of nearly 15% due to an increase in combined market share.
Alkermes reported manufacturing and royalty revenues of $52.5 million for the quarter for this product franchise compared to $47.6 million of revenues in the third quarter of fiscal 2012. For modeling purposes, I want to remind you that INVEGA SUSTENNA's royalty rate is tiered between 5% and 9%. On January 1st, the royalty is reset to 5% and will tier up through the calendar year as certain sales levels are achieved.
For AMPYRA and FAMPYRA manufacturing and royalty revenues were $18.4 million during our third quarter. In the United States, the quarter reported an unaudited AMPYRA quarterly net sales of approximately $73 million and guided to AMPRYA U.S. net sales of $285 million to $315 million for calendar 2013. Outside the United States, Biogen reported FAMPYRA quarterly net sales of approximately $10.5 million and total FAMPYRA revenues of $57.4 million for calendar 2012.
Turning to VIVITROL, net sales for the third quarter of fiscal 2013 were $15.9 million marking the 14th consecutive quarter of growth for the product. VIVITROL continues to show momentum with revenues that grew approximately 5% quarter over quarter. The actual growth is even better than that. If you recall last quarter, we changed our revenue designation model to a sales in model, which resulted in a one-time recognition of $1.7 million in sales. Excluding that, the net sales growth was 18% quarter over quarter. Year-over-year sales are approximately 50%. VIVITROL is beginning to perform and we're pleased to see it becoming a more meaningful part of our business.
During the third quarter, Alkermes recognized BYDUREON royalty revenues of $5.3 million based on estimated worldwide end-market sales of approximately $65 million, which is a 41% increase compared to estimated end-market sales of BYDUREON during the prior quarter.
Our third quarter was the first full quarter following Amylin's acquisition by Bristol-Myers, and their worldwide commercial office in partnership with AstraZeneca are still only just beginning.
In addition to the strong competition from our key commercial product portfolio during the quarter, Alkermes earned revenues from legacy products. The most significant of which was $9.8 million from the combined RITALIN LA/FOCALIN XR franchise and $6.8 million from TRICOR 145.
As expected and planned for during the third quarter, there was a generic entrant for TRICOR 145. Going forward, we continue to expect revenues from legacy product portfolio to decline. For the rest of this fiscal year, you should expect to see this revenue transition continue, with growth from our key commercial products offsetting these legacy product declines.
Now turning to expenses, operating expenses were $110.6 million for the quarter. This compared to total operating expenses of $130.6 million for the same period in fiscal 2012. This reduction was due primarily to the timing of clinical trial expenses and the inclusion of certain merger related expenses in fiscal 2012.
In addition, following the debt financing we completed in September, net interest expense during the third quarter was reduced by approximately $5.6 million to $4.5 million compared to the same period last fiscal year.
With strong performance across the business, we achieved non-GAAP net income of $46.5 million for the quarter, a significant increase compared to non-GAAP net income of $12.8 million for the same period last year. For reconciliation of our non-GAAP earnings to GAAP, I refer to our press release issued earlier today.
We ended the third quarter with $239 million of cash and total investments compared to $208 million at September 30th, 2012.
Now, let me turn to our financial expectations. As we enter the final quarter of our fiscal and gain more precision around VIVITROL sales and R&D expenditures, we are improving our financial expectations for fiscal 2013. The following line items are changing. We're increasing VIVITROL net sales guidance to a range of $55 million to $60 million, and consequently, we're increasing total revenue guidance to a range of $520 million to $545 million. We're reducing R&D expense to a range of $140 million to $150 million, and we are reducing our capital expenditures expectation to $20 million. As a result of these changes, we're increasing our non-GAAP net income guidance to a range of $135 million to $155 million or approximately $0.99 to $1.13 per diluted share. We're also increasing our expectations for GAAP net income to a range of breakeven to $15 million.
Finally, we expect free cash flow increase to a range of $115 million to $135 million for fiscal 2013. To generate this much cash, while investing in an exciting pipeline, shows us that the business model is working.
This was yet another strong quarter for Alkermes. The company's financial strength and the benefit of the company's portfolio business model continue to play out enabling us to improve our fiscal 2013 expectations again. With more than a year's solid results behind us, as Alkermes plc., we're pleased with the company's performance and look forward to delivering on our newly revised fiscal 2013 financial expectations provided today.
With that, I'll turn the call over to Richard.
Sounds great. Thank you, Jim. Good morning everyone. So, we're on a path to build out Alkermes into one of the next big biotechnology company. And to fully appreciate what we've created is to recognize that the company is characterized by two distinct portfolios. One is our commercial portfolio and the other is our emerging pipeline. The commercial portfolio, as Jim just discussed, is comprised of key products that are approved by the FDA and other regulatory authorities outside the U.S. They have long patent lives, and they're launching or in the midst of growing around the world.
This revenue generating commercial portfolio has been what most investors have focused on for the last 12 months. But at the same time that we've been building the commercial portfolio, we've building the development portfolio. And what's so gratifying as we move into 2013, is how exciting this late-stage pipeline is beginning to look, and how populated it is with a number of important new medicines with blockbuster potential.
I'll spend few more time on the pipeline in a second, but I want to take a minute to reflect on here and now, which is the commercial portfolio. If you look at this group of products, it's quite remarkable because of its diversity and the lack of covariance between the products and their importance to our strategic partners. We've good reasons to believe in the future growth of these products.
You've heard Jim talk about RISPERDAL CONSTA and INVEGA SUSTENNA our long-acting antipsychotic franchise; it's growing and providing benefits to payors and patients around the world. This is J&J's second largest pharmaceutical franchise and they're continuing to expand the product line with a three month INVEGA SUSTENNA now in Phase III.
VIVITROL is gained momentum with a variety of new initiatives happening around the country. Acorda is guiding to increasing net sales for AMPRYA and expects data from studies in post-stroke deficit and cerebral palsy this year.
Lastly, BYDUREON is just getting going with strong partners dedicated to a successful introduction around the world and with a submission for the first line extension expected this year. This commercial portfolio by itself would represent a very exciting biotechnology company, but we're using it as a foundation to build something much bigger. Superimposed on top of our commercial products is an exciting development portfolio with a potential to yield blockbuster medicines. Each one of our pipeline candidates has its own risks and potential liabilities, but the probability of one or more of these drugs achieving break out success is good.
I'll start with ALKS 3831, which we first disclosed at the beginning of the month. ALKS 3831 is our oral antipsychotic new molecular entity that is designed to compete with the best-in-class oral antipsychotic agents. The rationale is to create a novel drug with the efficacy of ZYPREXA without the metabolic side effects. ZYPREXA or Olanzapine is one of the most efficacious antipsychotic, but its efficacy comes at a high price, and that is a significant amount of weight gain. Over 50% of patients gain more than 7% of bodyweight on Olanzapine within the first year. Weight gain of this magnitude has serious clinical consequences including increased risk for type 2 diabetes.
So for many years the neuroscience community has sought to determine whether Olanzapine's efficacy could be achieved without the associated metabolic side effects. We had a hypothesis that opioid modulators, something we're quite familiar with, could play a role in attaining weight gain in patient receiving Olanzapine. So far I have our hypothesis it's proving to be correct.
We saw clear signals in preclinical studies that lead us to a human proof-of-concept study in a 106 healthy volunteers. Data from this study show that subjects receiving ALKS 3831 experienced significantly less weight gain compared to subjects taken Olanzapine. With this positive result in hand, we're moving to a Phase II study in mid calendar 2013 in patients with schizophrenia. This study will help us to determine the actual medical and commercial potential of ALKS 3831, as we will be measuring its safety, tolerability, and efficacy as determined by its antipsychotic activity and to a certain weight gain in the patient population of interest.
Moving on to Aripiprazole Lauroxil, our Phase III long-acting antipsychotic. Previously referred to ALKS 9070, Aripiprazole Lauroxil is our proprietary prodrug of Aripiprazole, which is a $7 billion drug sold around the world in an oral form as ABILIFY. Aripiprazole Lauroxil is a new molecular entity designed specifically to be administered via injection into a muscle and provide therapeutic effects for a month. Our drug is designed to build on the established clinical benefits of Aripiprazole, with a once monthly injection.
In addition to its expected safety and efficacy profile, we also expect to have competitive advantages based on two important attributes. First the product presentation itself, its storage and it's handling. It's a prefilled syringe of a stable suspension that is stored at room temperature and is ready for injection in the clinic. The second is the range of doses that we expect to be able to cover meaning that for patients taking oral Aripiprazole we expect to have injectable depot doses that cover any of those oral doses giving physicians flexibility in administering and choosing Aripiprazole Lauroxil over directly competitive products.
The Phase III 690 patient registration study is underway both in the U.S. and overseas. As we move ahead in 2013, we'll focus on completing the study, which if successful, will provide the basis for our U.S. NDA submission, and we're preparing for the marketing of this drug with the commercial plan to launch it ourselves in the U.S. and partner for markets outside the U.S. Enrollment is underway and we expect to have data in hand in late calendar 2013.
Turning to the third key development program ALKS 5461 is in development for treatment-resistant depression. The question we're seeking to answer with this candidate is can we decouple the anti-depressive properties of an opioid from its addictive properties. Again, our expertise in opioid modulation positioned us for innovation. And so far in animals and in our human work the theory has been confirmed.
In December, we completed enrollment in our 130 patient Phase II study comparing treatment with ALKS 5461 to placebo in patients with treatment-resistant depression. As we told you in the past, data from this study will be important in confirming the results seen in the first study, and we're on track with data in the second quarter of this calendar year.
The opportunity for new agent for treatment-resistant depression is huge because of the large number of patients. Nearly 10 million people receive treatment for major depressive disorder in the U.S. and over 6 million people require a second medication, and of those 4 million require third medication, and their treatment alternatives are very limited. Most antidepressants are based on conventional serotonin and norepinephrine based mechanism. When these approaches fail, there is a real treatment gap, and therein lies an opportunity for safe, well tolerated oral medicines with an alternative mechanism.
So 2013 is going to be exciting year for the pipeline. We have very important drug candidates advancing based on a strong foundation of data. With that said, our standards are high. We will advance only those programs that meet our criteria both medical and commercial. We've shown this discipline in the past and we will continue to do so. By the end of the year, we'll have a much better sense of what our next generation proprietary commercial portfolio will look like.
So, in summary, this is a company defined by these two portfolios. The development pipeline is advancing with key data readouts to 2013. The commercial portfolio is strong and growing. It's going to be an important year for us. We're right where we want to be and we couldn't more excited for it.
So, with that, I'll finish and turn it back to Rebecca for questions.
Thanks, Richard. We'll now open up the call for Q&A. Operator?
Thank you. We will now begin the question-and-answer session. (Operator Instructions) And the first question is from Cory Kasimov from JPMorgan. Please go ahead.
Cory Kasimov - JPMorgan
I've one on the pipeline and one on the commercial portfolio. So, first on the pipeline with regards to 5461 do you anticipate that the upcoming Phase II data in depression would be enough to enable you to make a go, no go decision for Phase III or do you -- are you anticipating you have to do additional Phase II work first if wanted? And then the commercial question is for Jim, I guess. Just wondering with the tiered SUSTENNA royalty can you tell us what the blended average turned out to be for calendar 2012? Thanks.
Hey, Cory, it's Rich I'll take the first question and the answer would be, we'll wait and see what the 130 patient study tells us so, it's too early to predict. What we hope is that we'll see a very clear signal like we saw in the first study. But we've a lot more data to work with in this study compared to the first one and we'll make a call on our next steps when we see those data. So, I don't need to be evasive about it just literally the way we're approaching it as we move into unbinding the study.
Yeah. Sure Cory and the blended rate, as you know, our tire from 5% to 7% to 9% and the blended rate for the year was around 6.5%.
Thank you. And the next question is from Steve Byrne from Bank of America. Please go ahead.
Steve Byrne - Bank of America
With just one quarter left in the fiscal year, Jim, what would you say are the key drivers to the range that that remains in your forecast? Is it the RITALIN TRICOR decline that is still quite uncertain?
Hey Steve, good question. I think we've driven our revenue forecast increase for our new expectation this morning really focused on VIVITROL and the VIVITROL increase, so that's what's providing the increase for us. And as you look at the sales for the year coming in around $44 million we clearly think $55 million to $60 million is a logical range for VIVITROL.
The rest of the spread really is going to come through in the portfolio around the 20 plus products that we have. So I wouldn't say there's any specific one and we are just to be clear too, we haven't seen generic competition for FOCALIN yet. We did see generic competition for TRICOR start in November.
Thank you. And the next question is from David Risinger from Morgan Stanley. Please go ahead.
David Risinger - Morgan Stanley
I've a question for Richard and then a few for Jim. Richard, could you just provide a little bit more color on the 5461 Phase II trial design including the unique aspects of it, and also comment on the criteria that you will be assessing in Phase II, i.e. the efficacy in depression, but also the combined mechanism and how you'll be assessing the combined mechanism?
Sure. Good morning David. The 5461 Phase II design is a 130 patient study that's randomized between doses of 5461 and placebo. And it's a sequential design that I won't go into here, but essentially give us a number of different ways of looking at efficacy of the drug as patients are randomized and then re-randomized throughout the course of the study. The statistical power of the study well actually what people talk based on the response rates that we've but the idea was to try to minimize the placebo effect during the clinical trials, so we can see the true effect of the drug.
In many ways I think the primary comparison, is just going to be that that principle comparison between the treated group and the placebo group and we're looking at any standard measures in that regard using HAMD as well as MADRS scores. But it's important to understand that this is a group of patients that are treatment resistant, so they would be -- would have a non-sufficient or insufficient clinical response to SSRI's or SNRI's, but they will maintain that background therapy in the course of the study towards an injunctive study if you will in this Phase II study. So we think we'll have a fair amount of end to work with and we've a look and we'll do all kinds of looks to try to convince ourselves of the true signal that we're seeing with 5461.
Thank you. And the next question is Catherine Arnold from Credit Suisse. Please go ahead.
Catherine Arnold - Credit Suisse
I have two questions. One is related to your revenue guidance and the other is sort of a longer-term pipeline question. On the revenue guidance could you just clarify what is now assumes to in regards to generic entry for FOCALIN XR, and then on the pipeline, obviously if you step back and think about positive surprise from your Phase I data for ALKS 3831, I think it sort of increases the markets curiosity about what else you guys have cooking from a platform on therapeutic perspective. And I'm wondering if you could give us a little bit of peak behind the curtain on some of the programs that you may have on a platform basis or on a therapeutic basis. Now I'm not sure we know the status of the ETD working nanotechnology for instance just on the other long acting applications that you might be doing. But do you think particularly interesting, I know you've a lot, I know its early stuff, but can you just give us a little bit of a peak of some kind things that we might wake up and be pleasantly surprised on the future?
Sure Catherine. I'll start on the FOCALIN side. We certainly are keeping our eye on FOCALIN and generic competition may come at any time. Given our manufacturing relationship there with Novartis, it won't affect us this fiscal year from a revenue perspective since we only have two or three months left and we haven't seen it yet. So we've a long enough lead time there to cover us from a revenue perspective this year. But going forward, that's one of the benefits of the portfolio as well, and that's why we give a range of guidance because we think we can, we can hit those numbers no matter what happens with FOCALIN for the rest of this fiscal year. So Rich you probably should take the portfolio question.
Good morning Catherine. So try the most important thing we needed this year is to get some value in this company for the current pipeline that we have. So I won't use today as a platform to announce other things that are simmering in the background. Other than to let you know of course we do. We've a company now that's developed 20 commercial products and we've got five key products that are growing and we've a technical capability and a manufacturing capability and certain insights that we continue to deploy in new developing programs.
Our strength of course is working in areas of precedent biology. We're not doing lot of blue sky research here. But we see often really important opportunities to improve the efficacy, safety, pharmacoeconomics, utilization of drugs or building on known pharmacology. One thing I didn't talk about that I should is it relates to things in the pipeline are that we do have some important things going in our collaboration, namely the three month INVEGA SUSTENNA in Phase III, the BYDUREON line extensions, that are in development, nice to AstraZeneca and Bristol-Myers pickup the baton on those, and see those as an important part of future for the BYDUREON franchise, as well as the clinical work that Amylin has ongoing with AMPYRA, which is obviously interesting molecule that we have applications outside of simply walking in and out. So, it is quite likely that you are on the R&D side that we're going to keep investors focused on the ones that laid enough that they should be worried about them.
Thank you. And the next question is from Jon Eckard from Citi. Please go ahead.
Jon Eckard - Citi
My first question has to do with the Phase III designs for 9070. Could you outline any similarities or differences in the patient enrolment criteria between your trial Lundbeck and Otsuka's Phase III trial for their depot ABILIFY product, the main reason for is just try to identify any potential risk for a higher placebo effect in your trial, which was not -- did not appear to be a problem in the Lundbckback trial?
Yeah, Jon, it is Richard. I won't go into go into the whole detail, I'd be happy to take you through it offline, but fundamentally it is a completely different study than the one in Otsuka. They ran study in maintenance stable patients can being maintained in schizophrenia. We are running an acute study versus placebo. And so, they are quite different and we are going to kind of extraordinary measures to make sure that we minimize placebo effect and enroll the right patients, which is why we are being so deliberate in the way that we chose sites and the way we monitor the sites and the way we enroll patients. So, that is why we chose that route because a single study will suffice for NDA submission in the U.S. and we really want to study to work.
Jon Eckard - Citi
And then, with regards to the SUSTENNA, I am not sure if you are able to comment on any kind of trends or updates for regional or country guidance regarding the use of long-acting agents. Have you seen a study up take in the use in ex-US regions in the European launch?
Yeah, Jon, we are not really a liberty to disclose J&J's country-by-country performance but as a broader conclusion, I think we have seen. And by looking at the IMS data around the world and the last group that we've purchased is through September. By comparing that to a year ago, the worldwide market share in the antipsychotic market for INVEGA SUSTENNA and RISPERDAL CONSTA has grown to almost just under 10%, and that's up pretty significantly from 6.5% to 6.7% range that we were looking at even just year, year and a half ago. So, we do see continued up take in the products.
J&J reported, the worldwide franchise grew 4% on a dollar basis, and as I said in my remarks, 15% year-over-year. So, I think they're very committed to that franchise as a whole. It is their second largest pharmaceutical franchise after Johnson & Johnson, and we certainly believe the new entrants with the long-acting form of aripiprazole will help continue that growth.
Thank you. And the next question is from Anant Padmanabhan from Cowen & Company. Please go ahead.
Anant Padmanabhan - Cowen & Company
I have a few. One on 9070 you briefly discussed the trials. Could you give us a sense of how the enrollment is going in the acute study? And then, any update on ex-U.S. partnering discussions?
And then on VIVITROL, it seems like some good underlying trends here, seems like the product is still going through the criminal justice system. So, could you talk about what is driving some of this near-term growth in VIVITROL? Thank you.
Anant, it's Rich, I'll take those. So the enrollment 9070 is an international study, and that study is being enrolled in the U.S. and in countries around the world. So the enrolment is going fine, and we're -- we expect to have data at the end of this year. So we've got a year ahead of us. So we'll keep updating you guys along the year as we go. But the underlying directive for the folks within the company is because we've such a strong belief that 9070 works, Aripiprazole Lauroxil works and metabolizes into aripiprazole, it's really important to run the study carefully and make sure we get the right result, because we're going to file off on this off this one study.
Ex-US, we're in discussion with folks, but we're not in any urgent hurry to do that deal that we do see, as Jim just mentioned in response to Jon's question, this is a global product, and we need to find a way to market for this on a global basis.
VIVITROL it's interesting because the growth from VIVITROL is not coming from these criminal justice initiatives that you're hearing about. It's coming from really our directed personal promotion in the commercial business that we've been focused on for the last several years, doing that better and smarter and more efficiently, and as wins begin to shift in further of more use of VIVITROL. Its part of the reason why we're so excited without a particular timeline associated with, with this criminal justice groundswell that's beginning to occur. Now with 21 programs happening in states and around the country it's not yet contributing a significant amount of direct carton sales of VIVITROL but it's certainly laying the groundwork and providing experience base that could lead to significant growth in VIVITROL in the future. So that's why we're so cautiously optimistic about letting those programs play out and then to seeing them translate into commercial sales
Thank you. The next question is from Ami Fadia from UBS. Please go ahead.
Ami Fadia - UBS
I think I have got three questions. Firstly, just a follow-up on VIVITROL. Could you give us some more color on when you expect some of these programs to conclude? And what would be the next step with respect to really getting that uptake in the criminal justice system, and maybe some color on the timeline around that?
The second question is, what should we look for in the 5461 study when it reads out and depending on kind of what that total is, I mean, what are you looking for in terms of the hurdles to start a Phase III study there?
And then, thirdly, could you give us some more color on the decrease in the R&D guidance? Was it just timing of trials or was there some sort of rationalization in the pipeline? Thank you.
Good morning, Ami. I'll take those. It's Rich. VIVITROL it's interesting on the timing of these programs because what we are learning is that it's very different than the world of biotech and science and completing randomized clinical trials and presenting data and having it peer reviewed. It’s a completely different ecosystem there. So, these programs are completing kind of continuously now as we go and they also -- they are not blinded so they’re pulling down data on a real time basis seen in many of this jurisdictions, and what we find that it's very viral. So, a sheriff in Barnstable County, Massachusetts wound up talking to a sheriff in Middlesex County, and then they'll go ahead and start with our pilot program as well. And these are ends of 10 people or 20 people or 30 people. That's why I say it's still so small; you're not seeing any numbers. But these aren’t folks that are waiting for randomized control data with p values off of less than 0.5 and so on. So, it's very hard to describe a timeline to it like wherever are used to working with. So, we are just going to let it play out.
On the macro trends, we see 7 states doing it a year ago, 21 states doing it now and more, more coming to the table. We see press, spontaneously generated about outcomes in communities with VIVITROL, where they interview judges or sheriffs or police officers or thing and patients. So, it's beginning to become much more of a viral phenomenon. But again, don't misinterpret that as saying if you're going to see a spike in VIVITROL sales next quarter because we'll know it when we see it and we'll be the first to share it with you when we see it.
On 5461, we are really looking forward, without giving a quantitative answer to the question; we are looking for a clear repeat of the efficacy that we saw on the first study. The first study was 31 patients, and we saw a p value in terms of reducing depression scores in patients that were previously nonresistant to treatment. So, we would like to see that if we see it -- if we see it that attenuate significantly. What we don’t want is chase a faint signal into larger studies. So, our internal view right now is that we wouldn’t launch a Phase III program unless we felt like we have the, a drug that was sufficiently powerful and an analytical method for detecting that power at a sufficiently high resolution to make sure that we would be more likely to succeed in Phase III than to fail. You saw another failed major depression study today where I just read the top line but 40% of the placebo patients responded compared to make 40% of the drug patients responding. That's the game we don't want to play. So, we're looking for an more enriched treatment set in patients that are already treatment resistant rather than frontline. And we're looking for a signal that we and you all can believe in.
On the guidance, I'll answer the question for guidance so Jim doesn’t have to, which is we got $160 million R&D spend and as we come in at the end of the year here with more precision, we’re just, there's no one element that drives all that. And actually Jim, you should try to answer the question.
Yeah, and Ami, it really does relate to the timing. We've got a number of clinical studies going on and as the studies one or two months out it’s a lot easier to predict than 12 months out. So it's really just precision around the timing.
Thank you, and the next question is from Mario Corso from Mizuho USA. Please go ahead.
Mario Corso - Mizuho USA
A few financially oriented things. On CONSTA, were shipments a little bit below what you would normally expect from the quarter? And on gross margin, seems to bounce around a bit from quarter to quarter, but looked particularly strong in 3Q. I'm wondering how we should best think about that in the near term and even longer term somewhere you were thinking at the time of the merger, are you still kind of thinking about a mid 70s kind of longer term goal? And then Q3 to Q4, anything in particular we should be thinking about that stands out in spending terms either in SG&A or R&D? Thanks a lot.
Sure Mario, no problem. Yes, on CONSTA, as you know, the manufacturing avenues are really based on J&J shipments. You might say it’s a little lighter than normal this quarter. They tend to take less in the month of December because they don’t want -- because of customs they don't want shipments hanging around getting cleared by customs around the world in the second half of December, but it’s a pretty -- it's still on the trend and we'll go up and down each quarter as we've talked about in the past.
On the margin side, it is really a similar thing. It really depends on product mix, US batches of AMPYRA versus ex-US batches of FAMPYRA; same is true with Consta and other products around the world. As you look at the margins as a whole, I think this was a good quarter. I still think for the year, you should think of gross margins in the high 60s area. And over time, I think the key drivers for our margins there are going to be the contributions from pure royalty products like BYDUREON and SUSTENNA. The bigger they get the better our overall company gross margins are going to be. The more VIVITROL we sell obviously the better our gross margins are going to be. So that's going to be a product mix change, which we will guide year to year, but that should evolve and improved over a time. And certainly, as we get our own proprietary products in the future, if you are talking about an Aripiprazole, Relaxol or a 5461 those margins can improve quite dramatically as we go.
And then in terms of guidance for the fourth quarter, I think there is a couple of things that you need to note on the revenue line. We talked about the resetting of the Risperdal -- excuse me of the INVEGA SUSTENNA royalty back down to 5% until we have $250 million in sales and it bounces up to 7% and then to 9% after that at $500 million and beyond. So, that's important.
The TRICOR generic entry will hurt us in revenues a little bit. Again that's included in our guidance, but that occurred in November with the TRICOR generic entry.
And then on the spending side, we do think that you know SG&A and COGS and R&D can be slightly higher in the fourth quarter, which we just to our guidance for the full fiscal year itself.
So, again the business is going well. No one quarter is a great representation of the business because the mix can change, but I think if you look at a couple of quarters or certainly the whole year, we certainly feel like we are moving in the right direction with growth and margin expansion.
So operator, I think we've time for two more questions.
Thank you. And the next question will be from Corey Davis from Jefferies. Please go ahead.
Corey Davis - Jefferies
Couple of questions. First on 9070, I think you referred to it as an NME, but that's not the thing you would expect to get NCE status on and then for five year exclusivity?
Corey, its Rich. Yeah, we expect it to be an NCE, but we actually expect it to have such substantial patent protection. The primary basis of exclusivity would be patent protection. So we expect that the actual designation of exclusivity be a subset of the (inaudible) exclusivity and I think we have patent now on Lauroxil now into the 30s.
Corey Davis - Jefferies
But you do expect the five years of exclusivity?
Corey Davis - Jefferies
And secondly, putting altogether all your comments about expenses and margins over the next five years should we think of Alkermes as a operating margin expansions story or would you manage your R&D especially to be more as a constant percentage of sales?
Yeah, I think Corey five years for sure. I mean, I think we are actually looking at both. We feel like we -- and we have set out some R&D targets, we have said in the $150 million to $180 million rage. We think we can get a lot of high quality generally clinical trials with an R&D because we do not have -- as Rich mentioned, we do not have buildings of scientist looking for new targets and new cures, which is -- it's wonderfully that people do that but that is not an R&D that we do here at Alkermes. We try and more purposeful clinical trial related R&D.
So, I think we will continue to keep R&D a focus of our spend. And as I think it is our product and exchanges to products like BYDUREON and SUSTENNA that are pure royalties and our impropriety products, certainly over that five year time we hope if we're successful than we do see margin expansion. More utilization of our manufacturing facilities as products grow is going to help. And more profitability from VIVITROL, VIVITROL is still right away on breakeven and as we start to see some net margin gain from VIVITROL and sales grow that is certainly going to help us as well. So, we think we are moving in the right direction.
Corey Davis - Jefferies
And last question on 3831. Would it make sense to also pursue a bipolar claim on that one or are you just going to stick with schizophrenia? And secondly, at some point did you have to do one of those typical combination studies, where you to show the combination beat each individual component because that would be kind of weird because each component does a different thing?
Yeah, that is right. I think right now we are going to stay focused in a step wise manner in the following way. We will stay in the schizophrenia indication, where the use of Olanzapine has such high efficacy and the weight gain can be so problematic and we are going to try to determine the full extent of the metabolic profile of the combination in the patient population of interest. And we will meet FDA this year on this product. We do not expect to have to do a single agent 33 component of that schizophrenia for reasons you allude to, and also, we do not expect there to be single agent of 33 available to patient. So, our current idea of embodiment of this technology is a tablet co-formulated with 33 and Olanzapine.
Thanks Corey. We will take one more question.
Thank you. And the last question will be from Terence Flynn from Goldman Sachs. Please go ahead.
Terence Flynn - Goldman Sachs
Just was wondering in terms of the out coming PDUFA decision for the long-acting depot from Otsuka and Lundbeck, I was just wondering how you think about the two potential outcomes of either approval or delaying and how that might impact 9070 from a commercial front? Thanks.
Hi, Terence, it's Rich. We are big fans of the approval of the Otsuka Lundbeck products because we really believe that long-acting injectable antipsychotic should deserve a larger share of the market, and that's going to require a larger share of voice. What we understand is that the delay in the first round of PDUFA dealt with something on the CMC side that was -- that looks to be easily dealt with sterile water for injection. And so, we're hopeful that they will get approval on that date and they bring the commercial intensity and educational intensity into the markets.
We expect to compete against that product based on the merits of our products, which are the product presentation as I mentioned in the dose range, but I think more importantly is understanding not just individual doctors but payment systems like they do in Europe, understanding that long-acting injectables are both good medicine and also good economics.
All right, everyone thanks for dialing in today, and if there is any additional questions please don't hesitate to call us here at the company. Take care.
Thank you, ladies and gentlemen, this concludes today's conference. Thank you for participating. You may now disconnect.
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