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Alkermes, Inc. (NASDAQ:ALKS)

F2Q13 Earnings Call

November 1, 2012 8:30 AM ET

Executives

Rebecca Peterson - SVP, Corporate Communications

Jim Frates - CFO

Richard Pops - CEO

Analysts

Anant Padmanabhan - Cowen & Company

Karen Jay - JPMorgan

Steve Byrne - Bank of America

Jonathan Eckard - Citibank

Bill Tanner - Lazard Capital Markets

Terence Flynn - Goldman Sachs

Ami Fadia - UBS

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Alkermes PLC Conference Call to discuss the Company's Second 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.

Rebecca Peterson

Thank you. And welcome to the Alkermes PLC conference call to discuss our financial results for the second quarter of fiscal year 2013, which ended on September 30, 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 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 risk and uncertainty.

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 and results 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 second 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.

Jim Frates

Thanks, Rebecca. Good morning, everyone. I am very pleased to report yet another strong financial quarter for Alkermes. The business has been performing well and our results for the second fiscal quarter came in at the high end of our expectations, driven by strong top line performance by our commercial product portfolio and lower costs.

In September, we were able to take advantage of favourable market conditions to reduce our debt and improve our financial structure with the refinancing of the term loans used to complete the merger with EDT last year. This will result in a significant reduction in our cash interest expense going forward.

Move over, based on the solid performance we’ve seen during the first six months of our fiscal year, today we are further improving our financial expectations for fiscal 2013, which I will go into in a few moments.

First let me start with the review from our results for the quarter. We recorded total revenues of $124 million, representing a 72% increase over the second quarter of last year, during which we completed the merger with EDT. This growth was driven by our key commercial products and strong performance from certain legacy products.

Let me now highlight the contributions from our five key commercial products. First, revenues related to our long acting atypical franchise RISPERDAL CONSTA and INVEGA SUSTENNA, which is sold as XEPLION outside the U.S. were once again the most significant contributors to our top line during the second quarter.

End market sales for RISPERDAL CONSTA and INVEGA SUSTENNA during the quarter were approximately $564 million. Year-over-year, the combined franchise grew approximately 15% on a dollar basis and as J&J reported, achieved operational growth of nearly 20% due to an increase in combined market share. For the quarter, Alkermes recorded manufacturing and royalty revenues of $50.3 million for this product franchise, compared to $44.9 million of revenues in the second quarter of fiscal 2012.

For AMPYRA and FAMPYRA, manufacturing and royalty revenues were $5 million during the second quarter, reflecting the timing of manufacturing shipments and lighter royalty contributions from FAMPYRA based on the $12.2 million in net sales reported by Biogen outside the United States.

Regarding ex-U.S. sales, recall that Biogen is booking the sales conservatively for the second half of calendar 2012 until final pricing negotiations in Germany are concluded in early 2013. In the U.S., Acorda reported net sales of AMPYRA that increased to approximately $69.8 million for the quarter and reiterated their guidance of $255 million to $275 million in AMPYRA sales for calendar 2012.

Turning to VIVITROL, net sales for the second quarter of fiscal 2013 were $15.2 million. As we mentioned in today’s press release, during the quarter we adopted a new revenue recognition policy for VIVITROL which resulted in a onetime increase of $1.7 million in net sales.

Excluding this adjustment, VIVITROL net sales were $13.5 million, marking the 13th consecutive quarter of growth for the product. VIVITROL revenues grew approximately 9% quarter-over-quarter and were up 36% year-over-year, net of the effect of the new accounting treatment.

During the second quarter Alkermes recognized BYDUREON royalty revenues of $3.3 million, based on estimated end market sales of approximately $46 million for the quarter. These end market BYDUREON sales represented a 33% increase compared to the first quarter and this in a quarter where ownership of Amylin changed and Bristol-Myers’ and AstraZeneca’s combined commercial efforts are only now just beginning.

In addition to a strong contribution from our key commercial product portfolio during the quarter, Alkermes earned revenues from legacy products, the most significant of which were $12.5 million from TRICOR 145 and $9.1 million from the combined RITALIN LA/FOCALIN XR franchise.

When we set forth our financial expectations for fiscal 2013 in May, we assumed that both TRICOR and FOCALIN would face generic competition, starting in our second fiscal quarter. To date, we have not seen a generic entrant for either of these products; but we do expect this to occur at any time. This scenario is one which we have long expected, planned for and communicated; and as we have said, we expect growth from our key commercial products to more than offset these legacy product declines going forward.

Now turning to expenses, operating expenses were toward the lower end of our expectations at $118.6 million for the quarter, which included non-cash charges of $29.3 million. This compared to total operating expenses of $83.7 million for the same period in fiscal 2012. With respect to interest expense, you should note that there is a onetime, mostly non-cash charge of $12.1 million relating to the refinancing as we previously disclosed in September.

Our non-GAAP net income for the quarter was $23.7 million, compared to non-GAAP net income of $7.1 million for the same period last year. For a reconciliation of our non-GAAP earnings to GAAP, I refer you to our Press Release issued earlier today.

As I mentioned at the start of the call, we believe that one of the key events of last quarter was the successful refinancing of our previous term loans in September. With a year of strong financial performance in cash generation is Alkermes PLC, our credit ratings were upgraded by both Moody's and S&P and this together with favorable market conditions enabled us to secure significantly more favorable terms on our new loans. Going forward we expect to save approximately $18 million in cash interest annually.

As part of this refinancing, we also applied approximately $83 million of our cash on hand toward reducing our debt and paying associated expenses. As a result, we ended the quarter with $208.2 million of cash in total investments, compared to $231.9 million at June 30, 2012.

Driven by our solid financial performance this year, strong revenues from our key commercial products and certain legacy products, and our continued positive outlook, we are improving our financial expectations for fiscal 2013.

The following line items are changing. We are increasing our total revenue guidance to a range of $510 million to $540 million. We are reducing our cost of goods sold expectations to be in the range of $160 million to $170 million. We are reducing our R&D expense expectations to a range of $150 million to $160million and net income tax expense is now expected to be in a range of $5 million to $10 million.

As a result of these changes our GAAP net loss is decreasing and is expected to be between breakeven and $15 million. We are also increasing our non-GAAP net income guidance by $25 million to a range of $120 million to $140 million, with approximately $0.88 to a $1.02 per share diluted.

Finally, we now expect an increase in free cash flow, to the range of $95 million to $115 million for fiscal 2013. Complete details of this improved guidance can be found in our Press Release issued earlier today.

This is a great quarter for Alkermes. We modeled and predicted the financial strength of the new company at Alkermes PLC's inception over a year ago and that strength is been borne out each quarter. We have confidence in the power of our product portfolio and are well on our way to achieving the improved financial guidance for fiscal ‘13 that we have set forth today.

With that, I'll turn the call over to you Richard.

Richard Pops

That’s great. Thank you, Jim. Good morning everybody. So as Jim just highlighted, this was a great quarter for us and we are positioned for a great year. It’s something that I’ve said before but it’s something that warrants repeating. With each quarter the benefits of our diversified portfolio become more clear.

Alkermes has this remarkable combination of financial strength and ramping growth, coupled with a late stage pipeline with tremendous potential. These two elements are not common in the bio-pharmaceutical industry, particularly for a company of our size.

So, we're actively managing this business not only from a financial perspective but across all fronts, including our development pipeline. So, spending a second on the financial here and now, we have the portfolio of five major commercial products contributing to top line; RISPERDAL CONSTA, INVEGA SUSTENNA, AMPYRA/FAMPYRA, BYDUREON and VIVITROL and during the second quarter we saw robust double digit percentage growth from three of them, INVEGA SUSTENA, BYDUREON and VIVITROL.

We've consistently talked about how each of our key product franchises early in commercial life with long patent protection extending predominantly into the 2020s. This quarter was a clear example of how our products can deliver substantially growing revenues to us and create a strong and vibrant base of growth for our business but the beauty of the business is it’s comprised of this portfolio of revenue sources and not all of these individual revenue sources have to show growth from one quarter to the next in as part of the portfolio and for the business as a whole to perform brilliantly.

We're also keenly focused on laying the foundation for our future growth by investing in innovative product candidates that can make an impact in important diseases that affect millions of patients. We have two late stage development programs that I’d like to give you an update on. First, its ALKS 9070. 9070 is our own long acting injectable aripiprazole for the treatment of schizophrenia and we believe there is a strong rational and large market opportunity for this product candidate.

The Phase III study for 9070 began in December last year and is on-going. The multinational study includes sites in the U.S. as well as in Eastern Europe, Russia and other countries. When we started this study last year, we said that we would plan for top line data in mid calendar 2013 and would update you on that timing as we gained experience with the study. We can do that today and we’ll say now that we anticipate data in hand in late calendar 2013. The is still an estimate but is based on our current enrolment experience in the U.S. which is ahead of schedule and a longer start up time in some of the Eastern European countries, which shift the enrolment out a few months.

Once we exit start-up phase in countries outside the U.S., we expect the enrolment rates in the U.S. (ph) site to occur as we originally modeled. So, we are focused on running the single pivotal study correctly and getting the most robust data set possible to position ourselves for a strong NDA filing. We are very excited about the prospects for this program and we believe it is a real opportunity for us.

The second proprietary candidate I want to discuss briefly is 5461. What we and others in the field found to be so impressive about this compound was that 5461 showed rapid and significant improvement in depressions scores in our first study. We are currently conducting a Phase II study of ALKS 5461 in 130 patients with major depressive disorder, who have an inadequate response to standard therapy.

This is a multicenter U.S. based study. Enrolment is progressing very well and we continue to expect to see data in the first half of calendar 2013. We’re focused on executing the clinical programs for 5461 and 9070 to the highest standard for success. These products candidates are important to our business and we’ll continue to keep you posted.

Finally, complementing our propriety development programs, we have partnered programs at our late stage. We have partnered with Zogenix for an acetaminophen-free hydrocodone pain reliever called Zohydro ER, which is currently in the FDA review and has a PDUFA date in March 2013 and our long standing partner J&J, recently provided an update on three months in INVEGA SUSTENNA saying on their earnings call that they’re planning for an NDA submission in 2014.

In addition, plans for BYDUREON line extensions continue to advance including the dual chamber pen and the ready to use dosage forms (ph) and we’re engaged with our new partners at BMS and AZ to actively support these programs. Our partners at Acorda are also running clinical studies to evaluate additional indications for AMPYRA and they expect to have data from the cerebral palsy study and data from the post-stroke deficit study in 2013.

So we’re seeing progress on multiple frontiers; financially, developmentally and from our partners. The business is performing even better then we planned for a year ago and we have been steadily building momentum. This was a great quarter for us and I look forward to updating you on our progress over the remainder of the year.

So with that I’ll return the call back now to Rebecca.

Rebecca Peterson

Thanks Rich. Okay. We’ll now open up the call for Q&A.

Question-and-Answer Session

Operator

(Operator Instructions). Our first question comes from Anant Padmanabhan from Cowen & Company, please go ahead.

Anant Padmanabhan - Cowen & Company

Just a couple of questions; first just wanted to get some clarity on the AMPYRA royalties. So if you look at the 18%, it seems like AMPYRA had a good quarter as you mentioned. So if you are getting about 18% royalties then excluding the Biogen contribution, it should be about a $12 million to $13 million. So I’m just trying to get a sense of how lumpy this is and how this affects the next couple of quarters of royalties?

Jim Frates

Sure, Anant. Good morning, it’s Jim. It’s a great question because it relates entirely to the fact that for AMPYRA in the U.S., we get paid on shipment of product. So we get all of our royalty on the shipment of product which is obviously very good for us because we get our cash flow a little earlier, than on sales. But our manufacturing revenues won’t be directly related to the AMPYRA sales and I think if you look over the course of the broader year, two quarters ago we were $13.8 million, last quarter we were $17.1 million, this quarter we’re at $5 million. If you look over the course of the broader year and you look at the AMPYRA guidance, a quarter’s guidance on $255 million to $275 million, we are going to be right in there at that 18% range over the course of the year.

The other thing too I would note is, I think this shows the power of our portfolio. So even in a quarter where we are very light, we only had one shipment of manufacturing over the course of the summer, September. It shows just how powerful the portfolio is with the rest of our products. We were able to have a very good quarter in the whole business.

Anant Padmanabhan - Cowen & Company

Okay. So Q1 AMPYRA royalties seem to reflect the sales at that time and I understand may be some product was shipped ahead of time, but Q1 seemed fairly in line. So Q2 had some lumpiness. So are you suggesting that Q3 and Q4 could be higher than projected sales, than the royalties from projected sales?

Jim Frates

No, I’m not saying that. I think again you have to look at a longer period of time to relate your sales rather than just three months, relate our shipments to the fact that the sales are going to be happening later on. So, I think if you look out over the course of a full year and you look at the AMPYRA guidance, I would say that our revenue from that is going to be very close to 18% of the sales that a quarter makes. It should be growing a little bit obviously as sales grow, because we will have to order product before those sales are growing, if you see what I mean.

Anant Padmanabhan - Cowen & Company

Okay. And then one more question on business development. Are you looking to acquire products and if so what sort of areas are you looking at and then besides the debt pay down, the requirement for debt pay down, is there anything else in your covenants that would restrict the opportunity set or flexibility to pursue opportunities?

Richard Pops

It’s Rich. I will take that one. We are actually always looking at business development opportunities for the acquisition of products. Also for the little out-licensing of products, we were very healthy activity at all times. I think that on the in-licensing side, it’s always a project of do things by exception, because there is a few really good efforts (ph) out there. Ours power ally is in the CNS and we tend to look at things that are in kind of Phase II and beyond in the CNS area and we really don’t feel constrained from a financial point of view to make the type of bolt on or like sized acquisitions in products that we will be looking to make.

Operator

Thank you. Our next question comes from Karen Jay from JPMorgan. Please go ahead.

Karen Jay -- JPMorgan

This is K. J. in for Cory Kasimov. My first question is on 9070. Assuming good data and drivers on the market, I’m just wondering if you would comment on how you see market dynamics playing out. Are you expecting share to mainly come from the short-acting product or from other drugs, potentially your current franchise and how much additional growth do you see from that entrant?

Richard Pops

It’s Rich. I think there’s two key dynamics to keep in mind as 9070 comes to market. One is the phenomenon that we have seen in the GLP-1 market which is the idea that more entrants are going to grow in the overall size of the long acting injectable market. The long acting injectable market, notwithstanding the efficacy and pharmacoeconomic benefit, in the U.S., is still remarkably small. It’s still on the order of 5% or so of the market; despite the fact that as we move to even more tightly managed costs and healthcare systems that these long acting injectables are valuable. So number one, we think that our entry as well as Otsuka’s and J&J’s continued presence will only grow in that market raising all the shifts. Number two, I think there's a very clear embedded base of aripiprazole oral patients in schizophrenia who are less than 100% compliant.

So, the long hanging fruit you would say would be the all oral aripiprazole patients in which they are several hundred thousand in U.S. in schizophrenia and coupled with this overall value proposition for long acting injectable markets. So for this reason, we're actually quite supportive of the idea of additional entrants coming into the market and do not see it as some game between our current product portfolio which is actually the dominant player in the field. It is a $2 billion product portfolio for us. We see that being actually enhanced as we and others come in the market.

Karen Jay - JPMorgan

And then just a quick second question on VIVITROL, is the growth in the sales primarily coming from the opioid indication and any updates on policy or strategy changes?

Richard Pops

Yes. I think the growth for now, is opioid indication. There's clearly a lot of interest in the opioid indications and major public health issue and VIVITROL is really differentiated unique product in that space. On the public policy, criminal justice initiatives, we won’t update on this call in detail but I'll just say that there's a whole host of individual programs bubbling up around the country and some of these are getting real momentum. It’s still too early for us to say that we can foresee the major hockey stick coming from VIVITROL, failed as a result of that, but overtime given the singular profile of this product and this patent line, we’re actually quite encouraged that this is going to be a fundamental field and it will continue to evolve over the next several years.

Operator

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

Steve Byrne - Bank of America

Jim, did you remove any of those debt pay down covenants when you refinanced the debt and if so, do you have plans for the $100 million in free cash flow?

Jim Frates

Our covenants are very similar to the covenants that we had on the previous debt. It is a covenant light deal which means there are no operating covenants that we have to hit or maintain. We do have amortization of debt. That’s required every year, and it’s roughly the same calculation which is 50% of our free cash flow each year. We will require to pay down debt or if we sell certain assets we have to use that money to pay down debt. So you will continue to see us paying down debt. I think when it comes to using our cash in the near term; we’re going to be focused on increasing shareholder value and as you saw last quarter we used, almost, 30% of our cash to pay down debt. A few years ago when we got our payment from our stake in Reliant, we did a large share buyback on that. So, we’re going to be focused on trying to get the best shareholder values we can and you’ll be seeing us doing all those things going forward I think.

Steve Byrne - Bank of America

And can you comment on what would be driving the increase in tax expanse in the second half and it appears from your guidance that the R&D expense will also go up in the second half?

Jim Frates

Yes. I think in reverse order, R&D expense is going to going up in the second half as we continue to enroll and broaden the enrolment in 9070 and some of the other programs that we have going on. That’s offset really by some of the lack of spend on beginning the Phase III on 37, which we had anticipated when we did our budgeting back in February and March.

In terms of tax, the tax is really related to the fact that in the United States this year actually where we’re generating more income than we thought we were going to generating in the beginning part of the year and so that’s where our estimate, going from a negligible tax and then we felt like we’re going to paying a small amount of cash taxes this year. So, that change is driven by improved profits in the United States, which is actually a good thing.

Steve Byrne - Bank of America

And just lastly, are you expecting an add comp for the Zohydro ahead of this Zohydro PDUFA ?

Richard Pops

Its Rich, yes, we are and I think Zogenix has said that as well, although I don’t think the date has been announced or scheduled yet in the federal register.

Operator

Thank you. Our next question comes from Jonathan Eckard from Citibank. Please go ahead.

Jonathan Eckard - Citibank

A quick question on 9070. When you talk about the market share for this product, could you compare what the market share for RISPERDAL was prior to the introduction of CONSTA, the long acting and how does this compare to market share that (inaudible) has today?

Richard Pops

In RISPERDAL oral tablets, were something anywhere of a $4 billion product and RISPERDAL CONSTA became something, about a $1.5 billion product. So it differs in the U.S. versus the O.U.S., but those are the base numbers of how the sales of long acting related to the sales of the oral tablet.

Jonathan Eckard - Citibank

And is there any reason to think that there could be a higher conversion rate with (inaudible) versus the RISPERDAL?

Richard Pops

I think there is an argument that it could be higher. There is also an argument that it could be lower in the aggregate. So I think it’s a more dynamic model than a simple answer on a call like this because you have to look at the spread of the U.S and the O.U.S. sales in schizophrenia and in bipolar and make kind of a dynamic modeling assumption about where the long acting injectable market is in general, what conversion rates by indication and by territory. So we think it’s a very substantial opportunity but I’d be happy to talk to you in more detail about how one might go about modeling, but I would just advise you, it’s not a simple model in our head.

Jonathan Eckard - Citibank

And then last question on 9070, with regards yours filing approach, is it quite similar to that of Lundbeck and Otsuka and that if we see a positive outcome from this, from their filing that we should assume that you guys are following a very similar approach, regulatory approach?

Richard Pops

Actually we define a sudden different regulatory approach in that we are developing a new chemical entity which is pro drug of aripiprazole. We’re running a single phase III clinical trial in acute schizophrenia with expectations of label for the treatment of acute schizophrenia in general will file in U.S., based on that single study. So it’s the same active (inaudible) if you were being tested in some of our patient population but a different trial design and a slightly different filing strategy, which has been by the way and I should repeat, embedded with FDA and we have a great amount of clarity over that regulatory path.

Jonathan Eckard - Citibank

All right. And then one quick question on BYDUREON. I’m not sure if you have any clarity into the dynamics into the quarter. Was most of the growth from the quarter from demand as far as you know or was there some stocking of drug that went into that sales (inaudible) in the quarter?

Richard Pops

This is Rich again. I don’t have a whole lot of visibility. I’m looking around the table, Jim or Rebecca whether you guys do as well. Our presumption is primarily demand driven, but Jim do you have any more queries on it?

Jim Frates

No, I don’t. The transition again; remember the deal closed in August. So the transition is one that was very real in the middle of the quarter, but we don’t know of anything odd. So our expectation would be the mostly it was demand growth but we’re not deep into those details.

Operator

Thank you. Our next question comes from Bill Tanner from Lazard Capital Markets. Please go ahead.

Bill Tanner - Lazard Capital Markets

Rich, just wondered if you could provide us with your contemporary thinking on commercializing 9070 and then is there any relationship I guess to the thinking there or the strategy depending on the readout on 5461?

Richard Pops

Yes. Hey, Bill, good question. I think as time passes, we’d probably get more and more excited about the idea of commercializing 9070 in the U.S. ourselves. You have heard us say this now for several months and that’s based on deep understanding of the market and of the potential attributes of our formulation, our product compared to, what the competition might look like. Recall that selling 9070 in the U.S. is not deploying a primary care or even a broad side sales for us. It’s a very concentrated group of physicians, something in the order of 5000 physicians and so, who like these long-acting injectables. So it’s a very manageable thing and it also leverages the mindset that we have been developing as we sell VIVITROL which is very focused on access realization of the injection ultimately into the patient and more than just detailing the benefits of the product.

So, it really doesn’t correlate a whole lot with 5461. It would be wonderful if 5461 plays through as well. The 5461 call point will be broader and slightly different than the 9071. And I have said before if 5461 reads out the way that it has the potential to, we think that’s a very, very substantial opportunity. That oral medication, it’s a new mechanism of action for the treatment of major depressive disorder and treatment of resistant depression. I think that’s going to be big news and we won’t thump the table about it yet until we get the data from this next study but if we do we’re preparing to consider that to be a global major product that’s going to require a fair amount of commercial support.

Bill Tanner - Lazard Capital Markets

But in the end Rich, it sounds like that might be something you’d being inclined to partner. So then if you had 9070 that you would take forward on your own. Is it fair to say that sometime between now and commercialization of 9070, Alkermes would be looking for additional assets to put into the portfolio?

Richard Pops

It’s possible, that’s right. Recognizing that 9070 is a kind of idiosyncratic asset, it’s a special injectable drug being sold into a fairly constitute group of physicians that absolutely once you make that commitment, it’s only logical to leverage infrastructure. Likewise that the incremental commitment to the commercialize 9070 is greatly facilitated by the fact that we’re in the market with VIVITROL, not that this is a similar call point in all cases, just if you’ve got all the commercial infrastructure necessary to responsibly and legally sell drugs in the U.S., it’s much easier to build on that than to create it from whole cost (ph).

Operator

Thank you. Our next question comes from Terence Flynn from Goldman Sachs. Please go ahead.

Terence Flynn - Goldman Sachs

I was just wondering if you could comment on the top line guidance increase, if it was primarily driven by your new expectations for TRICOR and RITALIN in generics as well as the VIVITROL revenue recognition policy and maybe how much of those goes into each component? And then the second question is just any insight in terms of why there might not be a generic for TRICOR RITALIN as of yet?

Richard Pops

Sure. Well, I would say the increase in revenue guidance is actually, first it has nothing to do with the change in VIVITROL revenue recognition. That’s really a onetime thing as we recognize the inventory that’s in the channel. So you will see that this quarter and then it’s really just a bliss and we’ll go back to really recognizing straight sales of VIVITROL. So that won’t impact it.

There is an impact of the delay in generic competition for TRICOR. I would say that’s roughly half of the increase in revenues, the other half being stronger growth in INVEGA SUSTENNA and other products in the portfolio including the other four of the big five products.

So, as to why there is not generic competition for TRICOR, I think I would only say that it’s probably very hard to replace as we have said all along, a lot of these drug delivery products, both oral and certainly injectable are very, very hard to duplicate and the company that had opportunity to sale the generic TRICOR has been unable to get it approved and that’s why we have seen a delay, although we expect that to change come January with TRICOR, but again the revenue growth is really driven partly by that legacy product but also by our continued positive outlook in our big five products.

Operator

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

Ami Fadia - UBS

A couple of follow up from previous questions. On 9070, what is your current thinking with respect to partnership and it looks like you intend to partner it only in Europe. Would you consider doing that before we get read out of the Phase III data? And secondly with respect to the earlier pipeline, besides the two lead products, is there anything else that you would highlight in your pipeline that we should focus on?

Richard Pops

9070 will maintain the position we’ve for the last several months which is, we are interested potentially in partnering the product in markets outside the U.S. and we are in discussions with various companies about that. We haven’t put it on a calendar because we don’t need partnership to advance the program the way we want to advance it and it only gets stronger as Otsuka moves to the regulatory process and as we move through our development process.

But given the fact that CONSTA is sold in 92 countries around the world, that SUSTENNA is launching around the world, these are global products and that makes them for us to have access in the markets outside the U.S. The earlier pipeline, there are some interesting things in the earlier pipeline. We’ve intentionally asked you not to focus on those because we haven’t disclosed them yet. We’ll probably disclose more about some of the next things stepping up in the coming calendar year.

Rebecca Peterson

Okay. Operator, we will take the next question if there is one.

Operator

(Operator Instructions) At this time, I am showing no further questions.

Rebecca Peterson

Okay. Everyone, thanks for dialing in this morning and as always, if you have any additional questions please don’t hesitate to reach out to us at the company. Thanks and 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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