Earnings Labs

Enact Holdings, Inc. (ACT)

Q4 2014 Earnings Call· Sat, Feb 21, 2015

$43.93

+0.00%

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Transcript

Lisa DeFrancesco

Operator

Good morning everyone, my name is Lisa DeFrancesco, Vice President of Investor Relations for Actavis and I'd like to welcome you to our Fourth quarter 2014 Earnings and Business Meeting in New York City. I'd also like to extend the warm welcome to those of you joining us remotely via Webcast. During today's presentation and Q&A, management will make projections or the forward-looking statements, which are dependant up on future matters or events. I'd like to direct you to the forward-looking statements regarding our projections in our presentation as well as in our earnings release and business update press release was issued earlier this morning including our important information for shareholders. Turning now to slide, 3 the agenda. I'd like to take a moment to review today's agenda for you. First, Brent Saunders our CEO and President and Tessa Hilado, our new Chief Financial Officer will review our fourth quarter and full year 2014 business performance. Bob Stewart, our Chief Operating Officer and Future Head of our Global Generics Business and Hafrun Fridriksdottir, our Senior Vice President of Global R&D for Actavis Generics and International will provide an overview of North American Generics and International and Global Operations and our Generics pipeline. Bill Meury, our Executive Vice President of Global Brands and David Nicholson, Senior Vice President of R&D for North American Brands will provide an updated overview of our North American brands commercial business and brands pipeline. Brent will conclude the meeting with the discussion on Growth Pharma and a review of our combined company following the close of the Allergan acquisition. At the conclusion of the meeting we'll take Q&A from the audience and I'd now like to turn it over to Brent, to open up the meeting. Brent?

Brent Saunders

Analyst

Good morning everyone, thank you for joining us today for our Investor Day, where we'll spend a good portion of today focused on our R&D pipeline. It's a little different than we first had anticipated doing obviously when we first set the dates for this meeting, it was prior to our acquisition of Allergan and so that causes to change the course a bit and make the meeting slightly different than it would have been because obviously we will have a full portfolio of review. So today's meeting just to keep in perspective will be Actavis standalone, this will be an Actavis standalone financials, Actavis standalone business review and Actavis standalone R&D pipeline review. I'd also like to welcome all of our shareholders, all of the analyst, cell side analyst that are here, our members of management that have joined us as well and in particular I'd like to welcome a few selected dignitaries that have joined us from our Board our Executive Chairman, Paul Bisaro is here, I think many of you know Paul. Cathy Klema, our lead Director over here and then we've three Allergan Board members who have joined us Peter McDonnell over here, Russ Ray, and of course, very pleased to announce that also joining us is the founder of Allergan, Gavin Herbert. Gavin, thank you for joining us. So I'm going to move to the highlights for the meeting. I think you've already seen the numbers. 2014 was an exceptional year for Actavis. We saw extraordinary growth across our base business, and transformational business development including the proposed acquisition of Allergan which will create a leading company in Growth Pharma. I'd like to touch briefly on the highlights of our performance and then Tessa will come up and provide more details on the strong financial…

Tessa Hilado

Analyst

Good morning, everyone. I am Tessa Hilado, the Chief Financial Officer. I joined two months ago, so my only request to all of you mild-mannered investors, bankers, and shareholders is to remember what your mothers told you when you were little, be kind and gentle to the new kid in the room. My son, who is a teenager, like any other smart aleck teenager, said to me one day that basically my 26 career in finance has spanned many industries. Since we were having breakfast one day and he was buttering his toast slowly with a butter knife he basically said to me, Mom, you have moved from cars to drugs to soda and chips and back to drugs again. And I looked at him and I said, son, my only correction at Actavis our CEO would say it's not drugs, it's not pharma, it's growth pharma. So moving on to more serious matters, I couldn't have joined the Actavis team at a better time. I would like to walk you through my presentation. I promise it will be brief since you have already the earnings release. One is our exceptional performance for the quarter and the year; two, drill down through the business segments that contributed to this exceptional performance; and lastly, walk us through our cash flow and say a little bit about our planned financing for the Allergan acquisition. I would like to focus your attention to the non-GAAP earnings per share of $3.91, up 23% from the prior year period. This is really largely driven by strong sales of about $4 billion, up 44%, driven by our base business. And in addition to that, if you will recall, this is the second quarter of which we have included sales for Forest. Both Bob Stewart and Bill…

Brent Saunders

Analyst

Great, so on a standalone basis let me talk about our situation. As you saw, clearly 2014 was exceptional and as a standalone company we are convinced that 2015 will be another very strong year for Actavis . So today we are pleased to increase our standalone forecast for 2015. We are increasing our 2015 Actavis standalone full-year forecast for non-GAAP EPS to $16.30 to $17.30. Our previous forecast was $15.60 to $16.80 on a non-GAAP EPS basis. We expect total net revenue to be approximately $15 billion following adjustments for the Durata and Auden Mckenzie acquisitions and the respiratory Doryx and Pharmatech divestitures. We expect that our non-GAAP R&D investment will be approximately $1.1 billion and SG&A as a percent of revenues will be approximately 19% by year-end. So as we continued to deliver on our financial commitments, we also believe we have many levers for future growth. We are a highly diversified company. We have a strong commitment, as you will see in just a few moments, to R&D and driving both our generic and branded pipelines. You will see that we have a pipeline on our brand business that could have sales over $6 billion in the coming years. You will see that our leading generic R&D productivity has created many opportunities for future growth, really leading the industry, not just by a little bit, but by truly blowing our competitors away. We tend to stay very focused on our core therapeutic areas in the brand side and we continue to invest strategically in our supply chain, making sure that we can deliver high-quality medicines around the world. We also are very opportunistic in business development and perhaps this year there was just a lot of opportunity, but we also look at every deal from a strategic…

Bob Stewart

Analyst

Good morning. It's great to be back here with all of you and it is exciting for me to talk, not only about operations, but also about our generics business. Our generics business is really the DNA of the company and our operations group is really the chassis of this company this company. It enables us to do all the things that we’ve been able to do and execute over the last several years. So my presentation is going to focus on our 2014 results in both our generic business as well as global operations. Then I'm going to turn the mic over to Hafrun, who will walk through a bit about our R&D programs. And then I will come back up and finish it up with 2015 outlook and some of the strategic drivers for us in the years to come. So I think when you think about our business a couple of things come to mind. The first is that we really operate our business in three different segments when I think about our generics business. The first is we've got a commercial organization that’s very diversified. We have the ability to commercialize products and OTC products, hospital segments, as well as generics and branded generics. And I'll talk through that a little bit more as I go through my slides later in the presentation. But also we've got an integrated model with our Medis business as well as our Anda Distribution business. Our Medis business allows us to participate in markets around the world that where we don't have our own commercial presence, so it allows us to get better returns on our investment, and I will talk through that a little bit in the presentation as well. And Anda is just an incredible asset that we…

Hafrun Fridriksdottir

Analyst

Good morning. Happy to be here and give you an update on the generic R& D. So it’s not only about development, it’s about the people which are doing the work. It’s about the people in all functions. We need to have the right people in portfolio to select the right product on the right time. We need to be able to design the right legal strategy around our products. We need to have the right API and then, of course, we need to develop the right formulation, analytical methods, and then, of course, we need to have the right clinical strategy. As Bob mentioned, quality is extremely important. Then manufacturing and regulatory. All those functions are equally important when we are developing a generic product. So where are we located? We are located all around the world. All-in-all we have around 1,800 people in generic R&D, 600 here in U.S. 600 in India, and then 600 in Europe. Most of our R& D sites, they are co-located with a manufacturing site and some of them are also in low-cost countries like India and other -- Romania and Italy. So, with doing that we get the most out of our R& D dollars. So what can we do? We can basically do whatever is out there. It sometimes scares my brand colleagues when I say that, but we can basically develop whatever formulation is out there. We have an extremely strong capability in solid oral dosage forms. Probably some of you don’t even know what solid oral dosage form means, but that’s all kinds of tablets and capsules. We have an extreme capability in semisolid and liquids, cream, ointment, foams, and basically in all area; in injectables, inhalations. And if we cannot do it ourselves, then we complement that with…

Bob Stewart

Analyst

So, I think you can see in those results it's just a phenomenal team. It starts with portfolio, making sure that you pick the right products, and then you execute flawlessly. And this team has just done it year-after-year and I am incredibly proud of their results. This is what's going to drive us value in the outlying years as we monetize these first-to-file opportunities. We’ve proven that we have the ability to do this. We’ve done it for years previously and we’ll continue to do it going forward. So prioritizing our opportunities is really the message here in 2015 and beyond. It's focusing where we’re strong and making sure that we continue to move ourselves up the scale and being a leader in the markets and in the therapeutic areas that we're going to compete in. Markets with significant growth potential, that’s where we’re going to focus our efforts. And what we’re going to look at is getting out of markets that, frankly, don't look like they’re going to be markets that are going to fit our profile going forward. Businesses that offer -- our business offers potential revenue synergies. None of those are dialed into our assumptions here, but as we think about cross selling opportunities in certain markets, because of the breadth of our portfolio and the breadth of the Allergan portfolio, we’re going to find opportunities to create revenue synergies. We’re focusing on the right segments; so INN generics, where it's profitable. We are not going to focus on being an INN generic company for commodity type products. We want to make sure that we’re investing in the right products with the right technologies to build durable assets that are going to offer value for the long-term. We are building an OTC business quite nicely, as…

Bill Meury

Analyst

Good morning, everyone. I always watch Bob's presentation very closely to make sure that none of my products are on his list. So what is the best way to think about our branded business? What are the things that will drive growth in 2015 and beyond? And what is the pipeline worth? I will cover some of those questions now and others later in the session. What we have at Actavis is a fully-integrated primary care specialty operation that's perhaps has the best new product launch capabilities in the industry. Very few companies have the depth and diversity of products and capabilities that we have. And right here are the core components of our operation. We have product line depth in seven therapeutic areas which we think gives us a strategic advantage, which I will cover shortly. Our business, from a provider perspective, is balanced between primary care and specialty. And from a payer perspective, it is balanced between commercial and Part D. In other words, we are not overly dependent on one market segment or customer. In other words, we are diverse but we are not too diverse. The fundamentals of our business are strong. Market share, growth rates, physicians' attitudes towards our products, usage patterns, formulary coverage, pricing are all, generally speaking, where we want them to be or headed in the right direction. Next we have one of the top performing sales and marketing teams in the industry and a great deal of organizational momentum right now and what do I mean by organizational momentum? I mean we have buying. The employees and commercial operations believe that they are part of something important and that they are part of building something that will last. Right now there is a great deal of energy being directed towards customers…

David Nicholson

Analyst

Good morning, everyone. It's a great pleasure to be here today and to have the opportunity to discuss with you the brands R&D pipeline. What is our R&D strategy? As a standalone company, Actavis focuses energy on four key therapeutic areas: gastrointestinal disorders, CNS, infectious disease and women's health. And we are opportunistic in urology, dermatology and cardiology. Of course, this is Actavis as a standalone company. We are all looking forward to bolting onto this the Allergan areas of expertise in ophthalmology, dermatology and aesthetics as well as their core research group in areas of ophthalmology and select agents. Actavis as a standalone company has built and we continue to build our pipeline through collaborations and in-licensing. Before I leave this slide, I do just want to come back to something that Hafrun pointed out and that is the ability of Actavis, the rather unique ability within Actavis to work collaboratively across the generics R&D organization and the brand's R&D organization. Something that in my experience in the industry is indeed unique. When I look in particular at the expertise that they possess in performing Phase 1 trials in process chemistry and in pharmaceutical technology that is a real strength that we are utilizing within brands R&D. It's not just a theoretical example. I can think of at least one example in the second half of last year where we had a major issue with the formulation of one of our brands development projects which was solved by the colleagues in our generics organization. To use Tessa's analogy, the brands R&D organization and the generics R&D organization are very capable of using the same butter knife. Let me come back -- let me now talk about our pipeline. Don't worry, I'm not going to go through all the boxes…

Bill Meury

Analyst

All right, morning again, from a commercial point of view, here is a way to think about our pipeline. David just reviewed nine mid- to late-stage assets in seven therapeutic areas. As I said earlier, we're entering categories with these compounds that we know very, very well. Customers know us; we know them. Next, we estimate that this product line pipeline could throw off $6 billion in sales, with four products having the potential to reach a blockbuster status. The compounds in the pipeline are novel, but not too novel; so that the probability of scientific and regulatory success is medium to high. We have a mix of products in primary care and specialty markets where there is an unmet need which in our view means the pricing and reimbursement dynamics around this pipeline in the future are positive. And then finally we have good IP, which means every strategic decision that we make around development and promotion and pricing will be made in the context of an extended exclusivity period. I'll touch on some of the key compounds right now. Eluxadoline is the flip side of Linzess: it's the perfect complement from a commercial standpoint. IBS is a continuum. You have IBS-C on one end, constipation; IBS-D on the other end, diarrhea. The fact is, there is not a bright white line between these two conditions, and with two products we'll be the only company that can talk about both ends of the continuum. We believe that's a competitive advantage. What you see on this slide are marketing attributes, and there are several. David talked about them. Pain relief on multiple measures at multiple thresholds, unlike any over-the-counter medication; sustained efficacy over six months, again unlike any over-the-counter medication. I think the most marketable attribute here relates to urgency-free…

Brent Saunders

Analyst

Thanks, Bill. So really I'd like to congratulate my colleagues for providing a lot of detailed information in a fairly compact period of time. What I thought I would do is bring the meeting to conclusion just by going through a couple thoughts as we think about our combination with Allergan that's coming and then open it up to Q&A quickly. So when you look at Actavis's performance over the last few quarters, you can see the momentum in the business. We continue to maintain strong momentum in our brand business, strong momentum in our generic business, strong momentum in each of our R&D organizations and maintain a best-in-class supply chain. When you look at Allergan and their reported results for the fourth quarter, you can see that that business, under David Pyott's leadership, has also experienced great momentum. And I believe their fourth quarter was their best quarter in their company's history. So we're taking two businesses that are firing on all cylinders, and we're putting them together. And as we do that, I think we have created a great strength in creating what we hope to call Growth Pharma. You've seen this slide before, we used it when we announced the combination of Actavis and Allergan. We do believe that we have a unique opportunity in the combination of Actavis and Allergan to create a special company that's focused on high growth, that's focused on innovation, that's focused on providing high-quality, reliably-supplied, low-cost medicines to patients around the world. And we think we can do this differently and better than anybody in our industry. And as you know we have an aspiration or target to grow our top line 10% in our branded business and after you back out generics and our Anda Distribution business, where revenue is…

Chris Schott

Analyst

Great, thanks. It's Chris Schott at JP Morgan. I had two questions. The first, just elaborating on those last comments on business development, can you just put a little bit more color around the priorities as we think about that $8 billion of free cash flow? When we think about the pipeline you just laid out, the launches over the next few years, the rate of change the organization experienced in 2014: really what are the priorities? What verticals do you see the most white space? Would you add verticals? I think we are trying to understand that element of the story. The second question was on the biosimilar opportunity. Obviously a lot more focus on that. Can you elaborate a little bit more on the commercial opportunity you see here? How are you thinking about price? How quickly can these products gain traction? And when do we see biosimilars as being a relevant contributor to the Actavis or Allergan P&L as we think about the longer-term profile?

Brent Saunders

Analyst

Yes, sure. On business development and the use of cash, clearly in the short term our top priority is to delever. We are absolutely committed to our investment-grade rating. We want to make sure that we act very responsibly. That doesn't take us out of the game in terms of doing tuck-in deals like the Auden Mckenzie deal that we did just recently. We are evaluating dozens of those types of deals all the time. But in terms of transformational deals, we are going to take a pause and certainly delever and allow our organization to focus on this combination for some time. I think in terms of areas of focus, they're really the areas that we are in. So it's those seven or eight therapeutic areas I just had on one of the previous slides. The idea there is to either look for complementary marketed product that can be sold through the same channel that already exists. It will be looking for pipeline opportunities, higher -- climbing the innovation curve, looking for complementary pipeline opportunities to support the therapeutic areas that we're already in. Or it will be geographic expansion or strengthening type of tuck-ins like the Auden Mckenzie deal.

Chris Schott

Analyst

Can I just ask one follow-up on that? Just when you say transformational, is there a threshold at which you’re defining that? Given how large the company now is, is a $10 billion -- is that a transformational deal for you guys at this point?

Brent Saunders

Analyst

Yes, I think transformational for me is less about dollar size; it’s more about doing something that we don’t currently do today. So moving into another therapeutic area, for instance; or a different -- perhaps -- I’m not suggesting we're going to do this, but into devices or something like that would be transformational. Certainly there are some deals purely on scale that you could argue would be transformational, even if they were complementary. But I think on all fronts we’re not going to be doing those in the short term until we have delevered. I think on biosimilars, I don’t know if Bill or David want to chime in here as well, but I have a view that investing in biosimilars today is critical to the future. It’s a longer-term bet. I think you're not really going to see the biosimilar market develop probably into the early 2020s. I think it will take some time. Ultimately, these will be big markets. The payer pressure and the cost pressures in healthcare will force these to be very robust markets. So I always analogize this to back in the Internet boom back in 1999 or before 2000. People had some really great ideas, but they just timed them wrong. And the same -- you have to be thoughtful about this with biosimilars as well. You have to make these investments; they take a while to develop; but you want to have these things launching towards the end of this decade, ‘18, ‘19, ‘20, so that you keep that momentum and can capitalize on the market when it really I think matures or develops in the early 2020s. I don’t know, Bill or David, do you have another view?

David Nicholson

Analyst

I certainly don’t have another view. Completely agree with what you’re saying, Brent. Perhaps just a couple of additional remarks biosimilars have been out in Europe for a while, and they are just starting to get into the U.S. market. First approval for a biosimilar in the U.S. very recently. The fact that we now have guidelines is going to help. But it’s also apparent that it’s turned out to be harder to develop biosimilars than many people thought a few years ago. I think we are seeing a smaller number of companies now working on biosimilars, which is going to increase the size of the opportunity for companies that do have the stamina and the technical expertise to stay in the area to really do things. But biosimilars are going to be a significant presence on the market also here in the U.S. eventually.

Mike Faerm

Analyst

Mike Faerm with Wells Fargo. My question is about potential divestitures and portfolio rationalization. We’ve seen you divest, for example, from respiratory. Not too surprising given the scale of that business relative to some of your others. So as we look at the seven or eight therapeutic areas that you laid out, should we be surprised to see potential further rationalization in some of those areas that maybe are a bit smaller in sales or number of products now? Such as cardiovascular or urology, for example.

Brent Saunders

Analyst

Yes, I think it’s unlikely. We’ll never say never. One of the things that I think we want to be evaluated as is good capital allocators. And that doesn’t just include buying good things; it also means divesting things when appropriate. I think the flip side of that is to maintaining the Growth Pharma concept. You also manage things differently. You don’t necessarily just keep things to milk them; if you’re not going to invest behind them, then you have to evaluate: should you be the owner of them? That’s a continuous process that we’ll go through. I think as we sit today and we look at the portfolio of our products, we are very satisfied that we have the right mix. On the margin, could something change and would we look to divest it? That’s certainly possible, but nothing else is in the works.

Mike Faerm

Analyst

Just one follow-up on the Namenda/Aricept combination. A lot of the conversation there has been about the opportunity from Namenda. Could you talk a little bit about to the extent to which you see there being an opportunity from the generic Aricept pool and the ability to tap into that?

Brent Saunders

Analyst

Yes. Bill, you want to -- you don’t need that microphone; you’re mic.

Bill Meury

Analyst

Yes, Mike, could you repeat the question?

Mike Faerm

Analyst

Sure. A lot of the talk on the opportunity for Namenda/Aricept has been potential from converting Namenda. Could you talk about the extent that you see an opportunity from the generic Aricept Rx population?

Bill Meury

Analyst

Yes, I think I understand your question. Our market share right now with Namenda or Namenda XR trades somewhere just north of 30%. For 10 years, the combination therapy market has been pretty stable. My sense is with a fixed-dose combination, the number of patients with moderate to severe Alzheimer’s who are taking two products as opposed to one could increase. We treat that as upside right now. Our focus is on simply moving IR to XR. But it wouldn’t take much of a movement in the frequency of combination therapy to add 10% or 15% to sales in 2015 and 2016.

Ronny Gal

Analyst

Good morning. Ronny Gal, Sanford Bernstein. I had two questions. It looks like in 2016 you’ll be generating $0.35 of free cash flow for every $1 of revenue you create. That is a fabulous free cash flow yield from revenue. The question is, Allergan is already paying, I guess, a small dividend. As you compete with other big pharma companies, some of them are growing quickly; would you be thinking about increasing the dividend to compete for the same -- with dividend news as well? There seems to be just enough money there. Second, you've discussed, Bill, the issue of the Massachusetts Model and the less access you now have for the doctor and more formulary restriction. Can you discuss this a little bit further? What will happen? Has this become a more popular model around the country? I guess one of the arguments is that a broad-based U.S. company is inherently more exposed to those pressures than a company with a lot of emerging market exposure or orphan drugs. So I guess it's a two-part question. First of all, are you as profitable in markets like Massachusetts as you are in Texas? And second, is Actavis considering expanding from a U.S. broad-based primary care market focus to orphan drugs, to emerging markets, and so forth?

Brent Saunders

Analyst

You want to take that one part of the question first?

Bill Meury

Analyst

Sure. We are as profitable, for example, in New England as we are in the South. We may get there differently, but part of managing these businesses is simply managing the level of investment relative to the sales return. My sense about consolidation is that it's going to happen at a very, very slow pace. Integrated health systems are still trying to figure out how they want to run their business, much less how they are going to interact with pharmaceutical companies. Our access rates -- and we've launched perhaps more new products over the past year and will launch as many in the next year as any Company -- are still in the 80%, 85% range. It's true that some regions of the country we have more access than in others. But at the end of the day, the only way the healthcare community -- providers and payers -- find out about new products is through sales and marketing. It's going to look a little bit different, but fundamentally it will be the same. I believe a company that wants to be a serious player is going to need a primary care and a specialty component, which we'll have. We may adjust the size of it over time, or redistribute it; but I would say for the foreseeable future, no radical change in how we do our business.

Brent Saunders

Analyst

Just to answer your other two questions, in terms of focus, clearly one of the things the Allergan deal does or the combination does is give us a very strong global footprint. So I think you'll see us continue to use that as a source of potential revenue synergies. Take a market like Latin America, where Allergan enjoys in many countries a number-one position in eye care. We have lots of dossiers and products that we could bring into Latin America, but we didn't have an infrastructure. Yes, we may have to build a different sales force, but that's very different than getting a legal entity, renting an office space, putting an IT person, an HR person, a general manager and so on. So I see that as one of our biggest revenue synergy opportunities, is to really complete the globalization of the new combined Company. Then finally with respect to a dividend, I think in terms of our policy of capital allocation, right now we have been focused on investing our money in growth assets, long-duration growth assets, and I think we've done that fairly effectively. That will remain our priority after we delever. So to the extent that we can't do that or we don't see many opportunities, our Board is very thoughtful and will continue to evaluate other ways to return money to shareholders, whether that be a dividend or a share repurchase, depending on the situation. But those are clearly priorities number two and three.

Liav Abraham

Analyst

Good morning. Liav Abraham from Citi. First question on Namzaric. Can you talk a little bit about pricing and market access dynamics of this compound as you head into a rollout? And any comments you can make on net pricing versus Namenda XR would be helpful. And then second question is on biosimilars. How do you think about potentially launching at risk in this space, given that the regulatory environment is evolving probably quicker than the IP environment? Or is this up to your partner, Amgen, for those products that are being there?

Brent Saunders

Analyst

Yes, maybe I'll answer that question and then ask Bill to talk about Namzaric. I think launching at risk is probably unlikely or unnecessary, particularly for the biologics that we are going after. As I said, I think most of these have patent issues that go up to about 2018. These markets really will develop till 2019, 2020, 2021, or beyond. So I think the idea of launching at risk given the slow adoption of biosimilars probably just doesn't make a lot of sense. But each one will have to be evaluated on a case-by-case, situation-by-situation analysis.

Bill Meury

Analyst

In terms of Namzaric, we believe that there is a price/volume point that we can obtain over the next 6 to 12 months that is going to make sense for health plans and is going to be acceptable to us. These are very popular products. One of our priorities is to make sure that patients and physicians have access to them. Our view is mid- to-long-term as it relates to both XR and Namzaric. Our plan is to essentially give Aricept away, and the combination will likely be at a discount to XR; but again, not an unacceptable discount. And as I said earlier, we're in open dialog right now, and we know where we need to be and how to get there. I think I'm encouraged by what we see.

Jason Gerberry

Analyst

Hi. Jason Gerberry, Leerink Partners. First, thanks, Brent and team for the detailed presentation. Just a couple questions; first on pricing trends for specialty brands, that 10% CAGR. Maybe, Bill, if you can just talk about your operating assumptions regarding any downward pressure on gross-to-net both for base business products and for the pipeline? And then my second question, just on eluxadoline: a pretty wide gap just in terms of peak sales guidance. So just kind of curious what you think are the key variables. Is it DTC in creating awareness in that market or is it really some of the labelling variables that are out there, either be it the DEA's control or the pancreatitis? Thanks.

Bill Meury

Analyst

In terms of pricing dynamics, they're largely built into our plan certainly for 2015 and beyond. What every company is experiencing right now are lower price points, and less frequent and smaller price increases. Most of our contracts, like most companies, have price protection. We have a mix of primary care and specialty products. I will tell you our customers I think in general consider us a predictable pricing company in terms of where we set our price and then the way we increase our price over time. Generally, we're at the midpoint, and our price increases are in the mid to high single-digits. And that's because most of our products have strong patents and long exclusivity periods. So it's a play for the long-term. As it relates to some of the specialty products in our pipeline, I would think about them differently than our marketed products. These are products for populations where there is a high unmet medical need. Gastroparesis is an excellent example; uterine fibroids is an excellent example. Avycaz is an example where there are no other alternatives; There are certainly no generic alternatives. And so, our price point for a chronic therapy is usually several dollars a day. Those products are of course going to be at a higher level than that. And we’re pretty conservative when it comes to building major price assumptions into our, let's call it, five-year plan, simply because the market is shifting and there is a great deal of pressure on payers to control costs. And we understand that and our pricing approach has to reflect that.

Louise Chen

Analyst

Louise Chen from Guggenheim. Thanks for taking my question. First question I had was that -- do you think that sales and earnings growth that we saw from Allergan in 2014 is sustainable? And if so, what gives you confidence that it is? The second question I had was; what keeps you interested in the generics business? You talked about 50% growth, could you provide more color behind that? Thanks.

Brent Saunders

Analyst

Yes, my view of Allergan's performance is that it is sustainable. I think where you saw a lot of the growth was in the expansion of Botox therapeutic, particularly migraine. You saw in one of the areas I know quite well, the eye health category, particularly Restasis, Lumigan, other products grow very nicely. And those are large and growing markets still. The filler launch, the Voluma, Juvederm Voluma experienced the best launch in aesthetic history because it's a great product and there is great demand. So, I think as long as we can continue to focus on driving those brands, to continue to drive innovation to support the product flow, those businesses should maintain or even experience more robust growth. Take a drug like DARPin that they have in early Phase 2. If we can get the profile we want for DARPin that may be the biggest drug in the pipeline of the combined companies in terms of sales potential. So there are lots of aspects to this very dynamic Allergan business and I think David Pyott and Doug Ingram and the management team there is just first-class. These guys have really built something very special there. And we, I think, have demonstrated a willingness to bring their very special and talented people into the combined leadership of the new company at a very high success rate and that continues to flow down as we’re building out the proposed organization in layer two and three and four and beyond. So, we’re very excited about it. And obviously, we'll know more when we close; but I have no reason to believe anything but strong performance.

Dave Risinger

Analyst

Dave Risinger from Morgan Stanley. Thank you for the details on the pipeline today. I have a few questions. First, one is regarding an opportunity on the generics side. So with respect to methylphenidate, there is a mid-May deadline for Mallinckrodt and Kudco to demonstrate bioequivalence. If they fail to do so -- and since the FDA has done the tests and seems to believe that they have or will be failing -- but if they fail to demonstrate the bioequivalence, how will Actavis respond from a commercial standpoint? And also, how can Actavis get the DEA to change over the allocation of scheduled drugs from competitors to Actavis ? That seems like a constraint, since the allocations are made annually, Bob. And then my second question is on Namenda franchise, whatever the run rate is in X dollars, let's say, in July, obviously if we put aside the twice-daily Namenda -- which will go off a cliff when the generics hit -- how should we think about the branded portion that remains in the form of the XR plus the combination? Meaning should we think about that declining in the future, because you have to give much greater rebates on the Namenda XR; and also some providers that are already giving patients multiple drugs twice a day will push volume to the twice-daily? Or should we think of that branded line that remains growing because of the combo? Just trying to understand how to think about where that remaining branded line will go over time. Thank you.

Brent Saunders

Analyst

Yes, maybe we will take the Namenda question and then I'll pass the [Audio Gap] the IR generics enter the market, the franchise will go into decline. So I think you have to -- and we model and I think you have to think about Namenda going into decline; and it's just a question of the rate of decline that it goes at. The higher the conversion rate, the better that picture is. The more we drive people to fixed-dose combination, the better that is. And as we expand the market with the DTC, the better that is. So there are some levers to be pulled in terms of slowing or retarding some of that decline, but it will never be enough to stop the decline. So I think you do have to think about it as a declining franchise. Is that fair, Bill?

Bill Meury

Analyst

That's exactly right. Just think about the rate at which it happens. If we are successful with XR and the fixed-dose combination, and we can manage price and volume, the rate will be [Audio Gap]

Brent Saunders

Analyst

Our model assumes that we will go through the conversion voluntarily, that we will reach somewhere between 60% and 70% on our own. Obviously, we have a court potential decision in March that could change that. That's now become Plan B versus the original Plan A; so that could change things quite a bit. But that's not how we're modeling it at this point. In terms of the generic, before I pass it to Bob to answer on Concerta -- I didn't answer the previous question. We love our generics business. The reason we like our generics business is because we are the best in the world at it. It is a source of growth, sustainable, long-term growth. And it also, I think, has the added advantage of being very strategic. It helps us think of our own portfolio in a sharper way. It helps us do business development in a sharper way. And the expertise in the R&D group is incredibly complementary and beneficiary to the R&D group. So there's -- we like all businesses that we are the best at, and we're the best at global generics.

Bob Stewart

Analyst

On methylphenidate, there are a number of things that we are doing. Right now today we are notifying physicians that there is an AB-rated generic out there, and it is ours; and making it clear that the other two competitors out there have been flipped to a BX rating. I personally think it's irresponsible to continue to market that product given that it was driven by adverse events and it was driven for lack of efficacy. So we're making physicians aware of that as well as practitioners. The other thing we're doing is we're working with J&J as well as with DEA to build up enough inventories in anticipation of the May 11 date. And we are making the assumption that they are not going to be able to continue to stay in the market. So we will have the inventory. We actually have the inventory now, where we can start converting the entire patient population over. DEA and FDA have really done, I think, and incredibly good job at working collaboratively to try and deal with drug shortage issues, in particular around ADHD medications. If you recall there was a couple years ago where there was shortages of Adderall in the market, shortages of Concerta in the market because of the fact that they were not responsive in terms of quota allocation. What they've now done is they've built enough aggregate quota that gives them now more flexibility to award quota as needed. And we're taking advantage of that with J&J to be able to ramp up our inventory levels to support the market.

Umer Raffat

Analyst

Thanks for taking my question. Umer Raffat from Evercore ISI. Maybe a couple of quick ones. Number one, on the 2017 $25 aspirational earnings target, is there any management compensation tied to that? Then separately on product side maybe, on eluxadoline, are we having any discussions with FDA yet on labeling? And also on relamorelin, the ongoing Phase 2b if it does confirm the vomiting effect that was seen in the last trial, would that potentially qualify for an FDA Breakthrough designation? Thank you.

Brent Saunders

Analyst

Yes. On the first question, on the $25 aspiration compensation, it's something our Comp Committee of our Board is evaluating and is possible. Management would like that, though. We will see. Our Board lead director's over there, so I'm looking at her. But I think that we'd put in a plan to tie our compensation to it. But obviously, the Comp Committee has the final say. You want to take the other two questions?

David Nicholson

Analyst

Yes. Eluxadoline, yes, we're talking to the agency about our submission, so we are in dialog with them, absolutely. And regarding relamorelin, yes, we have Fast Track designation from the FDA. Bill, you wanted to add?

Bill Meury

Analyst

There was a question asked earlier which I forgot to answer about the sales range on eluxadoline. It's basically a function of our ability to convert the over-the-counter market. And of course labeling always comes into play.

Randall Stanicky

Analyst

It's Randall Stanicky, RBC Capital Markets. Bob, one for you, bigger picture. You and I were both at GPhA last week. We talked or saw the FDA Target Action Date Initiative of 1,000 for this year on top of GDUFA timeline. So how do you think about -- given the size of your guys' ANDA portfolio, which is the biggest, how do you think about the volume opportunity for this year against what could be perhaps for the first time in a couple years some new variable in the pricing dynamic?

Bob Stewart

Analyst

Well, I think it's going to be interesting how that plays out company to company because when you look at the breadth of our portfolio, the number of exclusive first-to-files, the volume dynamic of more competitors coming in versus the exclusive first-to-files that we are going to start driving through, the net effect of that is still positive for us. So I look at it in the context that our portfolio, being as diverse as it is and how much of it is driven by first-to-files, the net effect I think is favoring us. But the FDA has made some pretty lofty promises at GPhA, and we've heard some of these promises before. We are seeing some definite improvement with the agency in terms of its acceptance rates. We filed the product on February 9 and we got an acceptance for file today, this morning. It just shows that FDA is clearly getting more efficient in how they are processing these. What they're doing in terms of the backlog, if they're going to get 1,000 applications through, I'm cautiously optimistic on that. But one of the benefits that we have this year is all -- the majority of the launches that we had planned for this year have already been approved and already are out in the market. So for us I'm looking at it as a positive for 2015.

Randall Stanicky

Analyst

The follow-up to that, Brent, on the one hand you have the brand business; on the other you have the generic business. How do you think about the middle, the 505(b)(2) opportunity, given that you've got these -- the capabilities from a delivery perspective; you've got the compound know-how. Is that something that, as you think about the next three to five years, it could be a big opportunity as you think about the hospital space, injectables, and others?

Brent Saunders

Analyst

It is. I think it's something that certainly excites me, not just in the hospital injectables where it's pretty intuitive that 505(b)(2) strategy would make a lot of sense. But I think as you think about the other therapeutic categories where we're in, where we have strong commercial capabilities, supporting those businesses also with select 505(b)(2) programs could make a lot of sense. We have a few that we are working on. Hafrun knows the one that I'm most interested in that, if it works, would be terrific. But absolutely, it's a core capability of putting a generics -- or strategic rationale for putting a generic and branded business together and operating it as one company, which no one else does.

Jami Rubin

Analyst

Right over here. Jami Rubin with Goldman Sachs. Tessa, a question for you; I promise I'll be nice.

Tessa Hilado

Analyst

I know you're nice, Jami.

Brent Saunders

Analyst

If not, I'll hit her with her butter knife.

Jami Rubin

Analyst

Last year there was obviously furor over potential tax inversion plays; and that came to a halt with the changes in the Treasury rules. Are you confident that any potential discussion about earnings stripping is now over and if not, can you quantify what the exposure would be to your tax rate should that come into play again? Not saying I'm hearing anything, but just what you're hearing. Also, just as the combined Company with Allergan, how should we think about the tax rate going forward? Is there an opportunity to bring it even lower than 15% as some of that IP is moved to Ireland?

Tessa Hilado

Analyst

Let me try to figure out all the questions. The first one was with regards to income stripping. I think the Obama announcement fairly recently has made it certain that any ruling on inversions would have to be dealt with at Congress; so we don't think that's going to happen in the foreseeable future at this point in time. With regards to the inversion and our tax structure, I think we're in compliance. We're in pretty good stead. That inversion has now been through like about two years.

Brent Saunders

Analyst

October will be two years.

Tessa Hilado

Analyst

October will be two years. So we don't feel there is any risk. So at this point it's going to be very difficult for us to quantify what that actually means. With regards to Allergan, at this point in time, they also have products that are sold in low-tax jurisdictions. So our best estimate at the moment is really the tax rate we provided to you, which is 15% post-close. Did I answer everything, Jami? Great.

Brent Saunders

Analyst

Have to get you with the knife.

Hima Inguva

Analyst

Hima Inguva from Bank of America. Thanks for all the color and taking my question. For Brent, thinking about future, looking at five, seven years out years from now, do you see Actavis as a standalone Company, especially given the high growth rates, low tax structure from inversions, IF there were to be a big pharma company that was interested in joining forces, will you be receptive to the idea?

Brent Saunders

Analyst

Yes, so I think as you think five, seven years out, we're in such a dynamic industry it's hard to predict what will happen. I do believe -- I've said this before -- this industry still has a lot of consolidation to go through. There's just too much inefficiency in the commercial capabilities of this industry, in the R& D capabilities and targeting and focus of this industry. So I think you'll see a continued consolidation over the next several years. That being said, when you look at the chart that's on this slide I think we've become, in my opinion -- and obviously I have a bias -- the most dynamic Company in the industry. So will we continue to be an acquirer, or will we -- will people look at buying us? I can't predict what others will do. But I think it would take an awful large premium to acquire a Company this special. I'd just leave it at that.

Sumant Kulkarni

Analyst

Sumant Kulkarni from Bank of America Merrill Lynch. I have three quick questions. The first one is on biosimilars. Does your agreement with Amgen at least conceptually allow for authorized biosimilars or ABs, as I think we should call them at some point? Secondly, on injectables we've seen a lot of moves in the markets including M& A activity. How specifically does Actavis plan to target that or get bigger? And finally, on Restasis, how is the Company thinking about the timing of potential generic competition, given that standalone Actavis may have been a filer there?

Brent Saunders

Analyst

Yes, maybe I'll take Restasis first. Obviously that was something that we were targeting, to try to create a generic Restasis before we did the deal. Obviously, we're not doing that anymore. And, look, I mean, the FDA changed the guidance. Our belief is that that probably knocked most of the people out that are going after it today. That's our intelligence; it's not perfect vision, but I think we believe that to be the case. But we also think there is a pathway forward for a company to do it. So our view is that Restasis has something on the order of magnitude of a four- to six-year life ahead of it. Very hard to predict exactly when. We have good intelligence, so we will keep our ear to the ground. But enough time for us to implement a lot of the plans the Allergan team had for product improvement and product extension, whether that be Restasis X or other dry eye molecules. So upon close we will be absolutely focused on making sure that the duration of the dry eye leadership at Allergan remains intact. And there are multiple levers to pull on that. To your other questions on the Amgen agreement with respect to authorized biosimilars, I actually don't know. I don't know, Paul, if you…

Paul Bisaro

Analyst

We actually do have.

Brent Saunders

Analyst

We do. Yes, we do have that in the agreement. I'm not sure that means a whole lot, in my humble opinion; I think we'll see how these things ultimately get commercialized and sold. We have some flexibility in our agreement depending on how that actually plays out. But my sense is what you'll see as biosimilars enter the market is the brands just drop the price to compete with the biosimilars. They will probably stay at a small premium for those patients and doctors who want the original drug. But the distribution channel may not look entirely different.

Corey Davis

Analyst

It's Corey Davis at Canaccord. I have two questions. The first one: now with nine products in mid- to late-stage development and still a lot of products that are still in launch phase, probably a luxury of riches. But can you really keep that SG&A margin at 24%, not add sales reps? Or do you need to add sales reps, not have the problem that Forest had a while ago, and launch these products effectively over the next couple years, and keep that SG& A margin intact and launch them properly? Question number two for David, back to relamorelin. If you only get an indication in DB for patients with severe vomiting, can this really be a billion-dollar drug? Yes, it would be great to have a pro-motility agent; but if you only get -- if it only really works in those patients, because that's what the Phase 2a data showed, would you need an indication in, like, dyspepsia to get it to be a billion-dollar product?

Brent Saunders

Analyst

Bill, you want to take the first?

Bill Meury

Analyst

Yes, I mean, Corey, the issue raised about the field force is one that we manage every day. It requires constant calibration. I will say that if the nine products we reviewed today were in completely different categories, then we would have SG&A problem to solve. As products move through their lifecycle from year one to year two to year three, we have to have the ability to moderate our investment so that we can increase it on new products. Given the overlap between the nine and our marketed products, I think we're going to be manage our SG&A in a way that would be very different if we were entering nine completely new categories. We still operate by the principle that we should be, in share of voice, number one when we launch a product. I think we still have the capacity to do that. But if we don't, I think it's just like R& D: if we need to make an investment to support creating long-term value for an asset, then we do that.

T essa Hilado

Analyst

I guess from an SG&A perspective, if you recall in 2014, we already ended the year at roughly 21%. So we have room in the forecast in terms of spending the money even to get up to 24%. So we think that's manageable, as Bill pointed out.

David Nicholson

Analyst

Regarding relamorelin, what I tried to do during the course of my presentation was to describe how for all of our products we aim to build a brand by ultimately going for multiple indications. I really do like to see during the course of development efficacy in a well-defined subgroup, because that's something that -- it obviously makes the whole development program much easier if you are looking at a well-defined subgroup where you get a clear indication of efficacy and safety early on.That was the point about my presentation for relamorelin. That's what really drove it; but we do seepotential for relamorelin in a broader range of the larger patient population.

David Amsellem

Analyst

David Amsellem from Piper Jaffray. Just a couple of questions. First on linaclotide, you talked about expansion opportunities, particularly the low-dose version. Is this something that could eventually become an OTC available product, similar to how the low-dose proton pump inhibitors eventually went to OTC? That's number one. Then secondly, on the OTC business, what's your appetite for growing this segment via further acquisitions? And would that contemplate acquisition activity in the US? Thanks.

Brent Saunders

Analyst

Yes, I think on the OTC business, we do like the business. It does have a really good, sustainable profile. I think the one thing you should recognize, too, in the combination of Allergan we do pick up a very nice US OTC business in the Refresh tear business, which is the market leader or among the market leaders in the OTC market. So I think we're going to continue to evaluate how do we gain strength both globally and domestically in OTC. I think you'll see us maneuver very strategically and opportunistically around OTC assets in the marketplace. Want to talk about Linzess OTC?

Bill Meury

Analyst

Yes. I mean the aim with a low dose, one, is to provide physicians with some dosing flexibility; but it's really designed to access a more mild, moderate, intermittent OTC category, which is really where the volume is. In terms of introducing an OTC version of Linzess, that is an option that we would consider if it made good economic sense, and especially if we are successful with developing a next-generation Linzess, which is the [colonic] delivery concept that David talked about.

David Nicholson

Analyst

Just to help you out, Bill, you said mild to moderate OTC. You meant mild to moderate chronic idiopathic constipation, CIC, right? Yes. Just to help you out. All these abbreviations.

Brent Saunders

Analyst

I just say butter knife.

Shibani Malhotra

Analyst

Hi, Shibani Malhotra from Sterne Agee. Quick question for David and Bill on eluxadoline. One, are you expecting a panel, given this is a new product? And then, commercially how do you expect this product to be used, given that IBS-D is multifactorial? Would you expect this to be the first line? How do you think doctors are going to differentiate between patients that have bacterial overgrowth versus not? Then second, a question for Bob. You've mentioned Advair many, many times now and you haven't given us much around timelines, etc., for when you think you could be on the market if you think you are first in the market. So if you could give us an update on that, that would be great. And if Brent could tell us which products he is excited about, that would be great as well.

Bill Meury

Analyst

Let me --

Brent Saunders

Analyst

Yes, you want to start?

Bill Meury

Analyst

Yes, I can start on the commercial question about eluxadoline, and I think Dave will take the other one. We don't really know how Xifaxan is going to be used relative to eluxadoline. What we do know is there is a real absence of treatment options. We know that the consensus, frankly, on bacterial overgrowth and the link to IBS is not completely clear, nor is there consensus on the prevalence. Xifaxan, don't get me wrong, is a very effective product. Our sense is we'll position eluxadoline, given its effect on transit, as a first-line therapy -- or I would say a firstline therapy after patients have tried OTC medications, which virtually all of them have. But again there is plenty of room for both of these products. We may find out at some point in the future that they can be used in combination alongside each other. But of course, those data don't exist right now.

David Nicholson

Analyst

And what was the first part of your eluxadoline question? Sorry.

Shibani Malhotra

Analyst

Are you expecting a panel?

Brent Saunders

Analyst

Panel?

David Nicholson

Analyst

Oh, a panel? Actually, we don't believe so, but the FDA can of course change their minds.

Brent Saunders

Analyst

So, Bob, you get to answer your Advair question.

Bob Stewart

Analyst

So on Advair, what I'll say is that we are becoming increasingly more confident in our application process. We're not going to be the company that's going to go out and do a press release when we enroll in clinical studies. If we did that, Charlie would have to triple the size of his organization, because you can see how productive Hefrun's organization is. But as I said before, that -- with Advair there's three things that have to come together. It's the device; it's passing a PK study; and ultimately performing a clinical endpoint study. The clinical endpoint is the easiest of the three and you need to have all three of those things come together before you ultimately can have an AB-rated substitutable product in the marketplace and that is what our goal is. It's not to go down the 505(b)(2) route, it's to go down the AB substitutability route. And so, all I'll say is that we're becoming increasingly more confident.

Brent Saunders

Analyst

Timeline? That's what he's confident about.

Bob Stewart

Analyst

That's why I'm confident.

Elliot Wilbur

Analyst

Elliot Wilbur from Needham & Company. I have two questions, the first is for Bob. As you think about rounding out your generic book of business, moving back into injectables and then rearming in topicals and I guess entering ophthalmics, are you confident that you have the internal capabilities or the partner relationships to become a meaningful supplier to the trade without making a strategic move in those areas? And then second question is for Tessa. Would it be possible at this point to get some sense of the level of interest expense expected in 2015 and embedded in your earnings per share guidance?

Bob Stewart

Analyst

Yes, I'll absolutely -- I'll answer the first part of your question, in terms of confidence, no question about it. I'm absolutely confident that that we've got the team in place that's ultimately going to be able to deliver value to the different segments, both in hospital as well as in other -- in topicals and the like, so no question about it. We've built up an infrastructure. We've invested in it. We've got good sales teams that are ready and have already launched these businesses. The other thing I'd say is that we are really focusing on being disciplined on the type of portfolios we're going to bring to this business as well. So we're going to differentiate ourselves on the portfolio side of things and be relevant to our customers based on what that offering's going to be versus trying to convince ourselves that we need to have the full breadth of products. So it's going to be really more opportunistic in terms of how we approach the business and really competing on more of a portfolio approach as opposed to trying to have the full breadth of portfolio, if you will.

Tessa Hilado

Analyst

So on your question given that we will be filing our S-3 in the next couple of days, we're really restricted from talking about the offering at this point in time. So, just stay tuned in the next couple of days. Obviously, given the fact that rates have moved lower since November 17, spreads have widened a little bit, so there's puts and takes there. And I talked about the two developments as well relative to the equity offer, which is better than expected earnings and cash flow both Allergan and Actavis reported for Q4 and then obviously the stock price has run up a little bit since the announcement itself. But stay tuned in the next couple of days.

Saba Hekmat

Analyst

Saba Hekmat from New York Life. A question for Tessa. Tessa, as you look at -- as you join this Company, it's much larger in size now and comparable to some of the big pharma companies out there. What's the appropriate capital structure that we should think about leverage and credit ratings for the intermediate and long term?

Tessa Hilado

Analyst

So we're basically committed to the investment-grade rating as we look at various acquisitions I mean obviously we always have a plan to delever rapidly in order to obtain that. In case in point, we were very disciplined when we announced the Allergan acquisition. From a leverage perspective, we've indicated that we believe post-close we would be down to 3.5 times and we would continue to maintain our investment-grade rating.

Lisa DeFrancesco

Operator

Okay. That's all we have time for today. I'd like to turn it back over to Brent for maybe some closing remarks.

Brent Saunders

Analyst

Yes and so I would just like to first thank everyone who attended live here in person in New York and those listening in on the webcast, thank you for your time and attention. I hope you see our enthusiasm for our Company and our future and our combination with Allergan. And we look forward to keeping you updated as we progress both on the offering as well as the close of the combination in the coming weeks and months. Thank you.