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Alkermes, Inc. (NASDAQ:ALKS)

F1Q13 Earnings Conference Call

July 26, 2012 08:30 AM ET

Executives

Richard F. Pops - Chairman and CEO

James M. Frates - SVP and CFO

Rebecca Peterson - SVP of Corporate Communications

Analysts

William Tanner - Lazard Capital Markets

Anant Padmanabhan - Cowen & Company

Thomas Russo - Robert W. Baird & Company, Inc.

Karen Jay – J.P. Morgan Securities LLC

Steve Byrne - Bank of America/Merrill Lynch

Graig Suvannavejh - Jefferies & Company, Inc.

Ami Fadia - UBS Investment Bank, Research Division

Mario Corso - Caris & Company

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Alkermes Conference Call to discuss the Company's First 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’d like to introduce your host for today’s call, Ms. Rebecca Peterson, Vice President of Corporate Communications at Alkermes. Please go ahead.

Rebecca Peterson

Thanks, John. Welcome to the Alkermes PLC conference call to discuss our financial results for the first quarter of the fiscal year 2013, which ended on June 30, 2012. With me today are Richard Pops, our CEO; Shane Cooke, our President; and Jim Frates, our CFO.

Before we begin, let me remind you that during the call today, we will make forward-looking statements relating to among other things, our expectations concerning the commercialization of RISPERDAL CONSTA, INVEGA SUSTENNA, AMPYRA/FAMPYRA, BYDUREON and VIVITROL, our future financial expectations and business performance, and our expectations concerning the therapeutic value and clinical development of our products.

Listeners are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to a high degree of uncertainty and risk. Our press release issued today, our annual report on Form 10-K filed 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 first quarter financial results and Richard Pops will provide a brief update on the Company. After our remarks, we will open up the call for Q&A.

Now I'd like to turn over the call to Jim.

James M. Frates

Thanks, Rebecca. Good morning, everyone. Very pleased to report a solid quarter for Alkermes. The business is performing as we expected and Alkermes financial profile has never been stronger. We’re on track to near expectation of over a half a billion dollars in revenue and non-GAAP net income in the range of $85 million to a $105 million for fiscal year 2013.

Now let me walk through the results. We recorded total revenues of $152.2 million, which is a 146% increase over the first quarter of last year, driven by the growth of our key commercial products, strong performance for some of our legacy products and license revenue.

I will start my review by highlighting the contributions from our five key commercial products. First, revenues related to our long acting atypical franchise RISPERDAL CONSTA, and INVEGA SUSTENNA, were once again the most significant contributors to our top line during the first quarter. End market sales for RISPERDAL CONSTA and INVEGA SUSTENNA during the quarter were approximately $550 million.

The combined franchise grew more than 14% on a dollar basis and nearly 20% on an operational basis year-over-year, due to an increase in combined market share. For the quarter, Alkermes recorded manufacturing and royalty revenues of $47.9 million for this product franchise compared to $48.5 million RISPERDAL CONSTA revenue in the first quarter of 2012.

This comparison is not indicative of the strong underlying growth of the franchise. As last years quarter included unusually high RISPERDAL CONSTA manufacturing revenues due to the timing of our shipments to Johnson & Johnson. What’s most important to our financials is that this franchise is growing and doing very well with 5% sequential quarterly end market sales growth.

Next, manufacturing and royalty revenues for AMPYRA and FAMPYRA were $17.1 million during the first quarter. Outside the United States, Biogen continues to launch FAMPYRA on a country-by-country basis and reported net sales of approximately $20 million for the quarter. Acorda is scheduled to report U.S. sales of AMPYRA next week.

Turning to VIVITROL, net sales for the first quarter of fiscal 2013 were $12.4 million, representing the 12th consecutive quarter of growth. This reflects more than 12% growth sequentially and approximately 28% growth over the same quarter last year.

During the first quarter of fiscal 2013, which was the first full quarter of the BYDUREON launch, Alkermes recorded BYDUREON royalty revenues of $3 million. This reflects our 8% royalty on an estimated $40 million in end market net sales during the quarter. Clearly this product is off to a great start and we’re excited about its future prospects.

In addition to our five key commercial products, during the first quarter of fiscal 2013, Alkermes earned revenues from legacy products, the most significant of which were $12 million from TRICOR 145 and $10.9 million from the combined RITALIN LA, FOCALIN XR franchise. For these products our financial expectations for fiscal 2013 anticipate revenue erosion from generic competition, assuming generic entry in mid calendar year 2012 with revenues declining by roughly half each quarter starting in the September quarter.

During the first quarter, we also recorded $20 million of intellectual property license revenue unrelated to our key clinical development candidates. This is recorded as manufacturing and royalty revenue. As we mentioned in our earnings call in May, we continue to expect total milestone in license revenue in the range of $20 million to $30 million for the full fiscal year, which was also included in our expectations for total revenue.

Switching to expenses, we continue to keep a short focus on managing the business. As a result, total operating expenses were in line with our expectations, at $120.1 million for the first quarter of fiscal 2013, which included non-cash charges of $26.2 million. This compared to total operating expenses of $75.8 million for the same period and fiscal 2012 for Alkermes, Inc which included merger related expenses of $9.5 million and non-cash charges of $7.6 million.

Our non-GAAP net income for the quarter was a positive $53 million, compared to non-GAAP net income of $3.6 million for the same period last year. These results included the $20 million in IP license revenue and no generic competition for TRICOR and FOCALIN, which we expect will change in the quarters ahead.

Nonetheless this quarter illustrates the transformative nature of the EDT deal and its effect on our bottom line. For reconciliation of Alkermes non-GAAP earnings to GAAP, please see our press release issued earlier today. From a balance sheet perspective, we ended the first quarter with $231.9 of cash in total investments compared to $246.1 million at March 31, 2012. This change was primarily driven by changes in working capital and we continue to expect to generate free cash flow in the range of $60 million to $80 million for fiscal 2013.

This is a very solid first quarter, with the business performing as we expected. We are off to a great start. With that said, since we’re only one quarter into the fiscal year, we’re maintaining our financial expectations for the year.

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

Richard F. Pops

Thank you, Jim. That’s excellent. Good morning, everybody. Let me start by asking to join me in congratulating Rebecca Peterson on her promotion to Senior Vice President of Corporate Communications at Alkermes. She plays a huge role here in the Company and I know for many of you on the phone, so richly deserved and congratulations.

Let’s turn to the business, we had a good quarter. To start off, I think its going to be a very good year. With each quarter the benefits of this diversified portfolio become more clear. We find ourselves in this fortunate position of having multiple commercial products in diverse markets with different commercial strategies and competitive dynamics. But let’s step back for a moment and look at the big picture, how we got here and where we’re going.

On a macro level, the ongoing global fiscal crisis and its resolution will have a long lasting impact on governments, countries, states, and on the pharmaceutical industry. Pharmaceutical companies will need to become even more innovative in order to compete and bring important new medicines to patients who need them. Safety and efficacy are not enough. Our industry will have to be incredibly focused on articulating all the benefits the medicines are offering, both medical and economic.

One of the ways to do this is to come up with cures for previously untreatable diseases. This is a laudable goal, but one that carries a lot of risk requires massive investment and a lot of time. The other way is to do what we’re doing, which is to take as a starting point drugs with a track record of safety and efficacy and build off that to create new medications to demonstrate both clinical and economic utility.

So what sets us apart at Alkermes is our approach to making new medicines. We apply our technologies and our expertise to create better products. We really think about how a medicine can be used over time in a chronic disease setting, with better outcomes for the patient as well as pharmacoeconomic benefits that are compelling to providers who increasingly play a role in determining whether a patient is able to get the medication that they need.

So our tag line patient inspired is very reflective of the treatments we’ve in the market and in our pipeline. RISPERDAL CONSTA, INVEGA SUSTENNA, BYDUREON, AMPYRA, FAMPYRA and VIVITROL represent these types of medicines. Unique in the classes, and offering compelling benefits to patients and payors, these medicines seem to us to be indicative of the direction the pharmaceutical industry is going.

Take our long acting antipsychotic franchise comprised of RISPERDAL CONSTA, INVEGA SUSTENNA known as XEPLION outside of the U.S. This business is growing rapidly and it has been for years. It has the potential to continue to grow for many more years because of the increasing awareness of the economic benefits of treating patients in the earlier stages of their disease with long acting medications with a goal preventing relapse.

Physicians and payors around the world, particularly outside the U.S., have figured out that if they can prevent relapse in patients with schizophrenia they not only improve the medical outcome for these patients, but they also save money from reduced re-hospitalization and slowing disease progression over time.

So Alkermes technology did not reveal a new pathway for the treatment of schizophrenia. What we did was create new medicines that enabled a fuller realization of the efficacy of the modern atypical antipsychotic. And this has led to a $2 billion franchise for our partners at J&J.

The same points are true for BYDUREON, which is the only once a week medicine of any type for the treatment of type 2 diabetes. BYDUREON is not characterized by its active moiety exendin-4, which is the same molecule as BYETTA. It’s distinguished by its tolerability, its efficacy, and its once a week dosing and how that fits into the lifestyle of a patient with type 2 diabetes, leading to take medicines for years and years.

The big news here of course was the announcement last month that Amylin will be acquired by Bristol-Myers Squibb, in collaboration with AstraZeneca. We view this as an extremely positive development for the future of BYDUREON. BMS and AZ will bring significant scale to BYDUREON by deploying additional primary care resources and leveraging their international footprint and experience in markets outside the U.S.

We are excited by the prospect that these two global companies will be communicating the benefits of BYDUREON to patients, physicians and payors. BYDUREON is very early in its commercial life. It has a long patent life, new dosage forms based on our technology under development, and a compelling profile. We look forward to working with our new partners to maximize the opportunity for this game changing medicine.

VIVITROL is like CONSTA, SUSTENNA, and BYDUREON. Proven medicine in a dosage form that has a profound impact on its potential for long-term economic and medical benefit. Here we continue to make steady progress in the opioid dependence indication and there has been increasing interest in VIVITROL by opinion leaders across the country. VIVITROL now has a track record of safety and efficacy in the real world to build from.

We are also just starting to see the results of some initial pilot studies being conducted by third parties in State Criminal Justice systems. We see this field as a major potential growth opportunity over time because of the increasing abuse of prescription pain killers and heroin, and a need for alternatives to incarceration and frequent recidivism.

AMPYRA is another one of a kind product. Our partners at Acorda continue to roll out new marketing initiatives and early feedback has been positive. Acorda’s partner Biogen also continues to make progress with the ex-U.S. launch of AMPYRA and now have launched the product in eight markets with planned launches in the remaining EU market. So those are the five major commercial products. The late stage pipeline is also advancing well and builds on the same themes.

ALKS 9070 is our long acting prodrug of aripiprazole, which is currently sold as once daily ABILIFY. The Phase 3 study of ALKS 9070 is on track for an enrollment goal of nearly 700 patients and we continue to expect top line data in mid calendar 2013. The medical and market forces propelling this program are the same ones driving CONSTA and SUSTENNA, which I described earlier.

The growing body of evidence of long-term efficacy and the pharmacoeconomic benefits of long acting atypical, underscores the importance of new long acting treatments for schizophrenia. Today there is only one sales force educating physicians on the benefits and clinical utility of long acting atypical and that’s J&J. We see new entrants to the market having a significant impact on growing the class. Otsuka has a new long acting atypical that could be the next entrant in this class and we look forward to hearing news on their product from the FDA very soon.

So where do we see ALKS 9070 fitting into this growing market? We see two differentiating features in 9070, the range of doses that we can deliver and the product presentation itself. Based on our clinical data, we believe we can offer 9070 dosage strength to cover the full range of oral ABILIFY doses, including the highest does that is commonly used to treat schizophrenia. This is an important attribute as it would allow clinicians to easily transition a patient from any daily oral dose of ABILIFY to a corresponding monthly dose of ALKS 9070.

In addition, we learned through our experience with CONSTA and SUSTENNA that product presentation matters in the real world. We’re designing ALKS 9070 to be a ready to use prefilled syringe.

For ALKS 5461, an opioid receptor modulator for treatment-resistant depression. A Phase 2 study is under way enrolling 130 patients. We expect to have data enhanced in the first half of calendar 2013. If these data confirm what we saw in our first proof-of-concept study, we will have drug candidate with some incredibly attractive features namely a well-tolerated oral treatment for a larger refractory condition based on the new mechanism.

Again, along with the medical benefits come potential economic benefits, as treatment refractory patients represent a complicated and potentially expensive group requiring more intensive medical and pharmacologic intervention.

So, finally I should mention that our partners continue to advance other late stage programs. J&J has initiated a Phase 3 program for a three month formulation of INVEGA SUSTENNA using our proprietary nanoparticle technology. Two Phase 3 studies are expected to enroll approximately 1,800 patients and are expected to be completed in the second half of calendar 2014.

Earlier this month, the new drug application for Zohydro ER, an extended release formulation of hydrocodone without acetaminophen was formally accepted by FDA and assigned a PDUFA date of March 1, 2013. If approved, Alkermes will receive manufacturing fees in royalties of approximately 20% on net sales of Zohydro ER.

So, we are firing on all cylinders here at Alkermes, both from a development standpoint and financially. We are advancing our proprietary pipeline candidate, actively collaborating with our partners to maximize the opportunities for our licensed revenue drivers, and managing the business deliver value for our shareholders. This was a great quarter for us and look forward to updating you on our progress over the rest of the year.

And with that, I will turn the call back over to Rebecca.

Rebecca Peterson

Thanks, Richard. With that, we will now open-up the call for Q&A. John?

Question-and-Answer Session

Operator

Thank you. (Operator Instructions) And our first question comes from Bill Tanner from Lazard Capital. Please go ahead.

William Tanner - Lazard Capital Markets

Thanks very much for taking the question. Jim, a couple maybe for you, just on the revenue guidance reiteration, I guess if you just look at it being flat going forward, you handily beat the high end. So, curious if there are some seasonality that we should contemplate or as Rich mentioned, I think maybe some macro issues or is the company just being a little bit more conservative at this point of time? And then secondly, is it relates to the EDT legacy products? Just curious if Alkermes would have any visibility on perhaps there being a longer tail for some of them, I guess, specifically TRICOR? Thanks.

James M. Frates

Yeah, you will – hi, Bill. Well, I think certainly you can look at our revenues and multiply the quarter by four and obviously we’re off to a good start this year. I’d first start by saying we’re only one quarter in and it’s early in the year to start predicting that the trends are going to stay the same exactly.

And there are two things that I’d point it to, one is, we’ve talked about, and your second question relates to this, the absolute expectation that we’ve had from the very beginning that TRICOR would see generic competition. As I mentioned in the notes, we’ve built into our plan that we see it in this – starting in the September quarter. And the FOCALIN franchise is going to see generic competition from certain dosages as well.

So, the longer that goes without generic competition, obviously, that’s going to improve our revenue outlook for the year. And at this stage, really just like Abbott we’re going to take the lead from our partner and wait and see, but plan conservatively.

Second, I’d say just as Biogen talked about yesterday on their conference call a couple of days ago, they’re making certain assumptions about FAMPYRA pricing in Europe going forward. They’re taking a conservative outlook at the lowest point they think the price will be. So, our revenues will be affected by that until the true up occurs and we know the true price in January. So we’re also reflecting that in the next nine months of planning.

I think that answers both the questions.

William Tanner - Lazard Capital Markets

Okay.

Rebecca Peterson

Bill, you had a follow-up?

William Tanner - Lazard Capital Markets

No, that was – just those two. Thank you.

Rebecca Peterson

Great, thanks. Operator, we’ll take the next question.

Operator

Our next question comes from Anant Padmanabhan from Cowen & Company. Please go ahead.

Anant Padmanabhan - Cowen & Company

Yeah, thanks for taking my question, and good morning and good afternoon. So I wanted to ask about the 9070 program, so on clinical trials you’ve the ongoing Phase 3 for acute schizophrenia and then a couple of other studies I believe, PK study, long-term study in stable schizophrenia. So could you talk about your regulatory strategy here, your discussions with the FDA and maybe contrast it with Otsuka’s Phase 3 design?

So that’s one, and then, could you also discuss any potential rationale for licensing this product ex-U.S. before the Phase 3 results? Thanks.

Richard F. Pops

Hi, Anant, it’s Rich. I’ll answer those. 9070 program, we talked about with you all before in terms of interactions with FDA, because we’re able to leverage the existing clinical information on oral ABILIFY we’ve an agreement that a single efficacy study will be sufficient for license here in the U.S. and that’s the study you refer to uncontrolled outcome, which is the 690 patients efficacy study that’s currently underway in acute schizophrenia. That will be sufficient for registration on the efficacy basis. We also have -- we’ve ongoing multi dose PK study as well, just to continue to roundup the file, but the rate limiting study is the study that I mentioned.

OUS, I think that one of the striking things about the atypical franchise that has been build by J&J is the amount of commercial sales of the products in markets outside the U.S, we’ve said before CONSTA sold in, I think in 92 countries around the world now. So I think it’s imperative for us to have an OUS strategy and that OUS strategy almost by necessity will include partnering.

And those discussions, we’ve kind of felt like we’ll be in a stronger position always to partner the product post Phase 3 data, but we’re in those discussions now familiarizing pharma potential partners with the program, and we’ll do a deal when it’s time to do a deal, but we’ve got – we’ve no expectations on when.

Anant Padmanabhan - Cowen & Company

Okay, thank you. Actually just a quick clarification on BYDUREON as well, so on the pen suspension and once-monthly formulation, could you clarify the royalty rate for those versions, is that also 8%?

Richard F. Pops

That’s right. It’s – you should model at this point, it’s part of that same base 8% on the first 40 million doses that drops down to 5% -- about 5.5% after the 40 million dose each year and then if we said each year.

Anant Padmanabhan - Cowen & Company

Okay, thank you.

Richard F. Pops

You’re welcome.

Operator

Our next question comes from Tom Russo from Baird. Please go ahead.

Thomas Russo - Robert W. Baird & Company, Inc.

Good morning, good afternoon and congratulations on the strong quarter.

Richard F. Pops

Thank you.

James M. Frates

Thanks, Tom.

Thomas Russo - Robert W. Baird & Company, Inc.

Just to clarify, Jim, your earlier comments on guidance, the $20 million for the IP license revenue, can you just confirm that was always included in the guidance framework for this year and that was not included in the milestones, $20 million to $30 million so that $20 million to $30 million milestones would be incremental?

James M. Frates

Well, Tom I think you’ve asked the question, it’s actually included, it’s always been included in our revenue guidance and it’s exactly in the 20 to 30 actually. So, part of that license and milestone guidance is the $20 million and we had 10 more to deliver this year to hit the $30 million, does that make sense?

Thomas Russo - Robert W. Baird & Company, Inc.

Okay, that does make sense. And then, maintaining the R&D and SG&A I think for the first quarter you’re running below the low end for both of those, is there – just in terms of the pacing going forward, is there certain timeframe where we should expect those to start to step up?

James M. Frates

Yeah, I think if you combine R&D and SG&A expenses, you get $120 million, if you multiply that by four, you get 480, our guidance was 485 to 520.

I think on the SG&A side, as you see VIVITROL sales continue to move, obviously we may decide to spend more in that area.

And on the R&D side, as we continue to enroll that with very large worldwide Phase 2 study for schizophrenia you’re going to see some expenses increase there through the year, but I think we’re comfortable with our guidance. We’ve always try to be conservative with it. And as I said earlier, it’s really hard to predict being only 25%, end of the year.

Thomas Russo - Robert W. Baird & Company, Inc.

Okay. And then last question, I’ll just try you on this, the Bristol/Amylin merger documents included some net revenue forecast that were up in the $4.5 billion to $5.5 billion range in the mid-20’s and presumably most of the line share that would have been BYDUREON, I’m just curious do you’ve any sort of comments as a company on that, that sort of outlook for BYDUREON or for the franchise dominated by BYDUREON?

Richard F. Pops

Hey, Tom, it’s Rich. I’ll answer it, and obviously we won’t comment on Bristol and its forecast because we don’t have them yet, but I was just simply thrilled to see the valuation placed on Amylin in this competitive process with multiple parties there and the valuation core that is you refer to is BYDUREON.

So with the application of this new scale to the commercial efforts for BYDUREON around the world and with our royalty participation everywhere, I think it’s really favorable for us. I was – you can almost back calculate based on the valuation where at least the minimum where they think these new products are going to go and I think that’s all very favorable for us.

Thomas Russo - Robert W. Baird & Company, Inc.

Okay. Thanks very much.

Richard F. Pops

You’re welcome.

Operator

And our next question comes from Cory Kasimov from J. P. Morgan. Please go ahead.

Karen Jay – J.P. Morgan Securities LLC

Good morning. This is Karen Jay in for Cory Kasimov. Thanks for taking the questions. I just have two. The first is on the long-acting atypical franchise and I wonder if you could comment a bit on market dynamics and share trends, it seems like RC is still holding and really well, so is that really – it’s still an underestimation of they’re of market size or is their share being taking some other products?

And then relative to CONSTA, are you expecting it to hold on to its market share for a meaningful amount of time going forward?

James M. Frates

Yeah, Karen, I’ll take a shot at that. I think the – we don’t have the particulars of J&J’s results in terms of where they’re gaining share. On each of the last many, many conference calls they’ve talked about the growth as increasing market share. So we’re not exactly sure where that’s coming from. Some quarter, it grows more in the United States, some quarter, it grows more ex-U.S. and they both seem to be doing very well overall.

In terms of the long-term success of RISPERDAL CONSTA, I think our view continues to be that RISPERDAL CONSTA is a product that has a lot of value, and we’ll continue to hang in there much more than people I think on the outside have given us credit for.

That being said, INVEGA SUSTENNA is also launching very well around the world. So that’s where you’re seeing the accelerating growth and we were certainly pleased to see the 5% sequential growth from last quarter.

Another no is the change in currency, the euro as we know has been under a lot of pressure year-to-year. So that affects RISPERDAL CONSTA more than it affects INVEGA because INVEGA has more relative sales in the United States, and CONSTA has more relative sales just because INVEGA is just launching in Europe.

So there is a little bit of that going on in the numbers as well, but overall with the $2.2 billion franchise right now, if you annualize the run rate and it doesn’t look like growth is slowing down. We’re just thrilled to be a part of it and to have 9070 coming in the wings.

Karen Jay – J.P. Morgan Securities LLC

Okay, sure. And my second question is kind of a follow-up on, and what we touched on about BYDUREON, you had any interactions with Bristol and AstraZeneca and maybe to the best that you can, have you walked away from those feeling they’re about their commercial strategy and a potential acceleration for the suspension formulation?

Richard F. Pops

This is Richard. I’ll take that one. I think until the deal closes, it’s not appropriate for BMS and AZ to have those interactions. We know both of those companies, so we’ll be ready to go as soon as that transaction closes and we able to download our points of view and our assistance and anything we can do, but I think that just reading what you guys have read, the public information about the way that the auction was conducted and the number of people that showed up the interest in the product is consistent with what our view would have been and that underscores our optimism.

Karen Jay – J.P. Morgan Securities LLC

Okay, great. Thanks.

Rebecca Peterson

Thanks, KJ. We’ll take the next question.

Operator

Our next question comes from Steve Byrne from Bank of America. Please go ahead.

Steve Byrne - Bank of America/Merrill Lynch

Hi. I wanted to ask a little bit about the $20 million in IP licensing, when you realize that is your partner here at the stages of just conceptualizing molecules with some long-acting functionality or are they at the point of putting something in the clinic?

Richard F. Pops

Hey, Steve, it’s Rich. We won’t comment anymore on the technology and even its specific applications or its basic nature. We’ve – as you know, we’ve about 1000 patents around here and we’re actively always kind of looking for ways to value and gain value from our IP, particularly idle IP that we’re not using in our lead candidates. So, hopefully this will be kind of an ongoing part of our business over the years as this IP franchise matures.

Steve Byrne - Bank of America/Merrill Lynch

But conceptually could these leave to a royalty generating stream like some of the other…?

Richard F. Pops

In this case you should think about this as a one-time payment, not with the tail on it. That won’t always be the case in each deal. Each deal we’ll have its own flavor, but this one just happened to be negotiated in a way that it’s a one-time payment.

Steve Byrne - Bank of America/Merrill Lynch

And Rich, you indicated that you’re in discussions with perspective partners on 9070, is that been your initiative or has that been more driven by the perspective partners?

Richard F. Pops

I think the fair way to say is we try to kick those off because this was a product that wasn’t really well known in pharma because we move from Phase 1b right to Phase 3 so quickly, but as you know, there is a big scarcity value for late stage products. So -- particularly with the Otsuka product coming along I think it’s going to attract the crowd.

Steve Byrne - Bank of America/Merrill Lynch

Okay. And then just one for you Jim, any update on your plans to buyback some debts?

James M. Frates

Thanks, Steve, for that. Well in another word, we’re continuing to expect that we’re going to generate $60 million to $80 million in free cash flow. You can expect to see more news on that through the course of the year. And I’ll just remind you that we’re obligated to do about half of the free cash flow under our term loan agreements. So, we’re watching the markets and we’ll be active on that before the end of the year, I’m sure.

Steve Byrne - Bank of America/Merrill Lynch

Okay, thank you.

James M. Frates

You’re welcome.

Operator

Our next question comes from Graig Suvannavejh from Jefferies. Please go ahead.

Graig Suvannavejh - Jefferies & Company, Inc.

Yeah, thank you, and I want to add my congratulations to a very nice quarter. I’ve got two questions, in particular, my both – I guess one relates mainly to the pipeline and certainly we’ve got 9070 and 5461 right now kind of in mid to late stage clinical trials. How are you guys thinking about perhaps the earlier stage pipeline in any desire to advance things there? And the reason I bring this up is, well, I thought the data for the compression asset was encouraging, it is a space that I’ve seen a lot of attrition rates and so just thinking about that next wave of products?

And then my second question just has to deal with a little housekeeping, I was just wondering if you could breakout in terms of the revenue from CONSTA and SUSTENNA just for modeling purposes? Thank you.

Richard F. Pops

Hey, Graig, this is Richard. I’ll take the first one and I’ll have Jim answer the second one. So part of the reason I say, what I said in my opening remarks, we put some context around the type of R&D that we do here and one of the other features of that type of R&D, which tends to build on non-pharmacology, but really view it through the patients lens and try to come up with drugs that have medical and economic benefit that we don’t do a lot of blue sky discovery or research here, a lot of what we do is fairly applied, we can actually think about what these molecules seem to look like on the whiteboard before we even begin designing. And as a result, we can actually do quite a bit fairly cost effectively. When you look at the R&D spent in this company, the vast majority is driven by those late stage programs. That’s why we tend to focus our public comments on those.

That said, we have a very focused and rich earlier stage exploratory work going on. This stuff tends to incubate for certain periods of time and when things are ready we will elevate them to the point where we’ll tell you that you should be concerned about them, so we’ll continue to do that within our R&D guidance of certain – something near to $160 million bucks, we feel like we’ve got plenty of room in there to continue to replenish the pipeline and as big Phase 3 study cycle through that freezes up budget and for the next generation of products. So that’s why we’ve always felt comfortable. Post EDT saying that we think the revenues can grow faster than the expenses, because we think we can manage new R&D within those parameters. Jim, you want to add?

James M. Frates

Yeah, sure. Greg this CONSTA SUSTENNA breakout and as J&J mentioned on their call, I guess last week; total sales for the quarter were $550 million, CONSTA sales were at $355 million around the world and INVEGA, SUSTENNA sales were $194 million, $195 million in that range. And then in terms of our revenue we had about $37 million in CONSTA revenue and a little over $11 million in SUSTENNA revenue, and that will be in our Q actually broken down in the MD&A and it was filed this morning. So if you want more detail you can look there.

Graig Suvannavejh - Jefferies & Company, Inc.

Okay, great. Just one last question if I could follow-up just, I think today is the PDUFA for ABILIFY depo and just any updated thoughts on how you’re thinking about – the Otsuka and Lundbeck opportunity and how that might impact the way you guys think about the opportunity?

Richard F. Pops

I am an unabashed fan of their success. I am like a broken record I’ll try to just – the same thing I used to say about Victoza’s role in the GLP-1 market that Victoza needed to be a big product to provide the milestones or the pathway for BYDUREON to become a big product.

And one of the big problems with the long-acting atypical business in schizophrenia is that there is a dearth of other sales forces and policy people advocating the use of these medicines. They’ve so clearly demonstrated benefits for patients and payors.

So with market share in U.S. under 5%, this market should grow and it can grow through new entry in more education and more pressure on payment systems to take a more enlightened view of the overall holistic cause of these patients in the better medical outcome. So I would like that drug to do well. We think our drug it was designed with features that should differentiate it from that product, but we want more players at this party.

Graig Suvannavejh - Jefferies & Company, Inc.

Okay. Thank you very much and congrats on the quarter again.

Richard F. Pops

Thanks.

Rebecca Peterson

Thanks.

Operator

Our next question comes from Ami Fadia from UBS. Please go ahead.

Ami Fadia - UBS Investment Bank, Research Division

Thank you. Can you hear me?

James M. Frates

Sure.

Rebecca Peterson

Hi, Ami.

Ami Fadia - UBS Investment Bank, Research Division

Okay, great. Couple of questions. First of all for Jim; with the nice cash flows coming out of the business besides paying back debt, are you thinking about anything in the lines of business development maybe in licensing other technologies? Any color you can provide there would be great.

Secondly on RISPERDAL CONSTA, based on sort of orders that you received from J&J these kind of got us a good start for the year with about $37 million in revenues. How should we think about modeling that going forward? Should we see some sort of seasonality or a dip going forward or not, if you could sort of help us get a sense there?

And – just the last question; there was an adjustment for deferred revenue. Could you offer about $3 million in the quarter? Could you give us a sense of what that was and how should we think about modeling that going forward? Thanks.

James M. Frates

Sure, Ami. Let me start with the deferred revenue, I’ll go backwards because maybe that’s the most technical. So, as we started to layout our adjusted net income procedures we looked around the industry obviously and we wanted to try and get as close to cash earnings as we could. So those small milestones essentially or what they are, are ones where we have ongoing work, ongoing with the partner what might use Zohydro as an example where we’re continuing to formulate and manufacture, and so the accounting rules say when you get a $1 million or $2.00 milestone in the door that you should spread that over the life of the work that you still have to do with the partner.

And rather than spreading that over what we've decided to do is take the milestones in our adjusted net income when they come in the door as cash and so what will happen now, so we’ve recognized that in the future we’ll actually be backing out those small amounts of deferred revenue that you would see running through our balance sheet and going forward. We’ll be backing those out of adjusted net income in the future.

So this year and next year as we've planned those should help us, and then it will depend on how the milestones go with the rest of our business is to whether that cash on the door will be more than the deferred revenue. But again you can look at our balance sheet and the deferred revenue. We have some deferred revenue from milestones that J&J has paid us for Russia sales in VIVITROL, for Zohydro and for some other small programs. So that’s the deferred revenue piece.

The CONSTA piece, again CONSTA has been doing very well and I think ahead of where Consensus would have it. This quarter there was 2% drop compared to last quarter and I think we've seen quarters where it’s flat, we’ve seen quarters where it’s grown. So I think as you look forward we’re seeing a flat-to-slow decline in RISPERDAL CONSTA, more than offset by the growth in INVEGA SUSTENNA. So again let me remind you is that franchise grows 14% on a dollar basis, 20% operationally compared to last year for J&J and 5% sequentially. I should also point out, we’re disclosing in our Q for the first time because the SUSTENNA numbers are getting bigger, the exact break points for the INVEGA SUSTENNA royalty. So again that royalty goes between 5% and 9% and up to $250 million every calendar quarter we get, so 0 to $250 million we get 5% on sales, $250 million to $500 million we get 7% and then on sales in a calendar year over $500 million we get 9%. So as you compare that to our net take on RISPERDAL CONSTA of around 7.5% the most SUSTENNA that gets sold actually the better-off we do economically. So economically we’re really indifferent and the growing franchise is the key. And at $2.2 billion run rate right now we’re pretty pleased with that franchise in general.

And then in terms of the cash flows, I mean, we look all the time at potential in-licensing, certainly at both end things that are accretive which is we’re obviously focused on driving our earnings right now. I think we have a deep pipeline of things on many products but we’re always looking at other potential deals, we’ve done that for years, and we’ll continue to do that. I think it’s very clear that repaying debt can be accretive to us financially. We’ll look at repurchasing shares; we’ve done that in the past. And obviously we’ll have to do the valuation work on whether new technologies are going to be more accretive than those alternatives. But that’s something we do all the time and we’ll continue to update you on that when we make decisions obviously.

Richard F. Pops

Ami its Rich, let me just make one additional point on that and keying off your – this specific question you asked which was, are we interested in licensing other technologies? We are actually less interested in licensing technologies per say, i.e. formulation of our delivery technologies. We have evolved the business now to where the proprietary products are driven by product. So we’re actually interested in always looking at product development opportunities where we can bring our particular expertise to bear, but I think the days of our licensing platform technologies for the purpose of partnering with others, those days are probably over.

Rebecca Peterson

I think we have time for two more questions. Thanks, Ami.

Operator

Our next question comes from Mario Corso from Caris & Company. Please go ahead.

Mario Corso - Caris & Company

Yes, thank you. Congratulations on a nice quarter. I wanted to ask a little bit on gross margin and taxes, any updated thoughts there. It looks like gross margins are a little bit ahead of last quarter and then in terms of CONSTA and SUSTENNA; what kind of forecast or what kind of plans even directionally do you think we should be thinking about in terms of the franchise growth, I mean, an acceleration or continuation or slight deceleration over time? Thanks very much.

James M. Frates

Sure Mario. On the margins, we did have a good quarter. I think some of that goes with the vicissitudes and timing of manufacturing shipments. But I would also point out though as BYDUREON and SUSTENNA continued to grow those are a 100% margin products. And as AMPYRA and VIVITROL continued to grow those are products that we manufacture. Our margins will get better as we push more. The fixed costs don’t change. We’re in a very good position there and as we push more products through our margins should get better in general. So we’re looking forward to hopefully expanding manufacturing margins as we go.

From the tax rate as well; again as our products that are based in Ireland including BYDUREON and SUSTENNA do better, and we still have some substantial NOLs we can take advantage of. Long-term, I think structurally we’re very, very pleased with where our tax rate will be, so we should continue to see benefits from that going well. And then the last question, could you repeat your last question, Mario?

Mario Corso - Caris & Company

Yeah, in terms of the CONSTA SUSTENNA franchise, just wondering how you guys are thinking about it or how you think we should think about the franchise growth over time. Acceleration and maintaining the current growth are, really decelerating over time?

Richard F. Pops

This is Rich; maybe I’ll take that one Mario. I think in terms of – if you just look at the J&J franchise I think the trend line is looking backwards is what we would extrapolate from. I think the dynamic in the marketplace is interesting given and the potential new entrance. If Otsuka comes into the market and increases the noise and brings more data and is pushing access in particular with Medicaid and outside of the U.S. as well, I think the market can grow. So I think to be conservative, we would just model at some trajectory extrapolating from where we've been, but with some hope and expectations that the market based on merits could grow.

Rebecca Peterson

Okay, John, we’ll take one more question and then we’ll wrap it up before the market opens.

Operator

Okay. Our last question comes from Bill Tanner from Lazard Capital. Please go ahead.

William Tanner - Lazard Capital Markets

Yeah, thanks. Rich, I just had a question on the three month SUSTENNA. I’m just curious, if you could remind us what the all in royalties for SUSTENNA versus CONSTA, but then as it relates to the three month, I mean is the contemplation if this would then replace the one month, I mean, do you have a view point as to whether this could potentially expand SUSTENNA and whether potentially it could erode CONSTA, just some color around that will be great. Thanks.

Richard F. Pops

Yeah Bill. I think that in my view that, that each of these dosage forms kind of opens up a new shell of doctors and patients that might not have been available to the first generation Q2 week RISPERDAL CONSTA product. So what we've seen in the numbers is that SUSTENNA didn’t cannibalize CONSTA, it took over some of its growth, but it opened up the market to franchise. Remember when it was CONSTA alone was about $1.5 billion growing and now its $2.2 billion growing. And I think the three months again, it won't be winner take all on any of these things. I think that will just allow certain patients that are stable to segue to a longer dosing interval, but these patients have schizophrenia, right. So they’re not going to be left on their own ideally I think for three months at a time. They need more frequent interactions with care-givers. So I guess, I would be optimistic that it’s just part of this growing utilization long-acting atypical in general. Jim before had reiterated the split and I’ll have him do that again just so you might not have heard on the CONSTA versus SUSTENNA economics.

James M. Frates

Yeah. So the structure Bill would be the same for our license for the monthly SUSTENNA. The three months would be the same which is that tiered annual sales based royalty that goes 5%, 7%, 9% and puts us right in the same ballpark as the 10% net 7.5% that we get out of RISPERDAL CONSTA.

William Tanner - Lazard Capital Markets

Okay, perfect. All right, thanks very much.

James M. Frates

You’re very welcome.

Richard F. Pops

Welcome.

Rebecca Peterson

Great. Everyone thanks for dialing in and if there are any other follow-up questions please don’t hesitate to contact with us here at the company. Have a great day.

Operator

Thank you, ladies and gentlemen. This concludes today’s conference. Thank you for participating. You may now disconnect.

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