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Forest Laboratories, Inc. (NYSE:FRX)

Citi 2013 Global Healthcare Conference

February 27, 2013 10:20 am ET

Executives

Francis I. Perier - Chief Financial Officer, Executive Vice President of Finance & Administration and Member of Disclosure, Legal Compliance & Risk Management Committee

Elaine Hochberg - Chief Commercial Officer, Executive Vice President of Marketing and Member of Disclosure, Legal Compliance & Risk Management Committee

Frank J. Murdolo - Vice President of Investor Relations

Analysts

Liav Abraham - Citigroup Inc, Research Division

Liav Abraham - Citigroup Inc, Research Division

I am very excited to be hosting Forest Laboratories this morning, and we're very fortunate to have Elaine Hochberg with us. Elaine is Chief Commercial Officer of Forest; and Frank Perier, who's the CFO; and we're also joined by Frank Murdolo, Head of IR. Thanks, guys, for joining us. I don't know, Frank, do you want to start off with the Safe Harbor statement.

Francis I. Perier

Yes. Just a quick opener that some of the comments that you may hear this morning may have forward-looking information as defined by the Private Securities Litigation Reform Act and actual feature results may vary. Please see our complete disclaimer on our website, www.frx.com. Thank you. Keep the lawyers happy.

Question-and-Answer Session

Liav Abraham - Citigroup Inc, Research Division

Great. Let's start off with Elaine. There's a lot going on at Forest at the moment in terms of -- both in terms of your end-market product portfolio, as well as your launches. And for those of you who don't know, Forest, is in the process of launching -- or have recently launched 2 very interesting compounds, one called Linzess, the other called Tudorza. So perhaps you can just start off by giving us your thoughts on the Linzess launch. These are 2 very different launches, but perhaps we'll start with Linzess. We've been following the script trends versus some of the other drugs that are on the market, or if it were in the same class if it were on the market, looking very, very promising. What are you guys seeing on the ground? And what are you -- how are the marketing efforts going? And what is the feedback that you're getting from doctors, from patients, from your sales reps?

Elaine Hochberg

Thank you, Liav. Good morning, everyone. It's lovely to be here. It's the first time I'm actually addressing a group in a public forum like this, so bear with me. A macro question about both of the launches -- a macro statement, I guess, is that as we all know we launched right around the holiday season. So in a certain way, we're looking at these launches really in what we consider the first real 5 to 6 weeks since the beginning of January. And with that in mind, Linzess is performing very, very well, as is Tudorza. And we have lots of qualitative, as well as metrics. To be fair, it's still very early. But nevertheless, when we look at that early performance in the last 4 weeks, Linzess, in fact, it's prescriptions have grown 100%. In the last 4 weeks on Tudorza, prescriptions have grown 50%. When we look at prescriber universe, which is a key metric for us and any launch that we have done in 15, 16 years I've been at Forest, we are getting, in the last week, for both of those drugs over 2,000 prescribers actively writing. Now why do I identify a specific number? One of our benchmarks, particularly in drugs that serve both the primary care audience and the specialty audience, we like to see somewhere within the first 3 months of launch about 1,500 prescribers coming onboard on a weekly basis. Usually, what that predicts is by the end of the year, you'll have tens of thousands of physicians prescribing which usually for primary care specialty-based type of products, you need to get to somewhere between 60,000 to 70,000 to 80,000 prescribers within 18 months. Tudorza, specifically had 2,400 last week against Linzess -- 2,400 versus Linzess 2,000. So very early on, really only 5 real weeks on the marketplace. We've seen prescription drugs and prescriber growth in a way that would suggest that we will meet our goals for the drugs in the first year.

Liav Abraham - Citigroup Inc, Research Division

So just to be clear, because actual prescriptions, this is apart from the sampling?

Elaine Hochberg

Yes. It has nothing to do with sampling. It's IMS reported prescription. And I know that there's always a lot of questions about sampling. And let me just tell you Forest's philosophy on sampling. It's not just a philosophy, but it's one that we measure to death. We strongly believe that the market has to experience the drug; that practitioners, when they're working with patients, particularly with new drugs, want to sample that product and evaluate that patient. And it usually takes them a significant portion in the first year of trying it on all types of patients. The traditional pattern is they give it to the worst patients first, the infamous Weber Effect, and slowly bring it out to more and more parts of the population. In our first year of launches on any drug, we almost sample as much as we sell. But what is the point of that sample? Giving that practitioner that experience, usually aids year 2 and year 3 and beyond, because they have been able to experience the drug as richly as possible. Now there's another element to sampling, particularly with what we call early adopters, selling traditional, fashionable launch somewhere between 80,000 to 90,000 physicians, of which may be 1/3 -- 25% to 1/3 could be our early adopters. And we know from days of launch of Celexa, Lexapro, Namenda, Bystolic, drug after drug, that if you get to those early adopters with what we call our early sample program, basically it's a month's worth of sample, they, in essence, are able to do their own mini trial amongst their patients. And those doctors who do that, they have high potential, they can be early adopters; at every time point, post launch, tend to be somewhere between 5% to 10% ahead of the highest prescribers that are not treating that way. So we have a very rigorous way to measure the responsiveness, as well as the return. And so we really consider samples a fundamental tools to help the physician audience understand the drug and adopt it. So when I give you a prescription, part of that, we firmly believe and know from our measurements are being generated by doctors experience in the drugs, and the support we give in all of our programs that include the sample.

Liav Abraham - Citigroup Inc, Research Division

And what is the early feedback that you've been receiving from doctors? And again it's only been a couple of months since you've launched, but what is the early feedback that you're getting both on Linzess and on Tudorza?

Elaine Hochberg

Okay. That's a very good question. It is very early. We do have informal networks with doctors and, of course, we have a lot of access to our field about what they're hearing, and we're very pleased with what we're hearing on both drugs. The drugs are performing pretty much in line with what our clinical trials were. What doctors are seeing are a meaningful clinical effect. And we're also getting feedback that size tech [ph] profiles are operating exactly the way they were described, and they are manageable by the physician practicing audience. So right now, it sounds from the early feedback, very, very good.

Liav Abraham - Citigroup Inc, Research Division

So that obviously bodes well for repeat prescriptions.

Elaine Hochberg

Yes, it does.

Liav Abraham - Citigroup Inc, Research Division

Great. Focusing a little bit on Tudorza, I'd be interested if you could help us contrast this launch to the Linzess launch because looking at script trends, people may bucket them together, 2 new launches, kind of look at them side by side, but they are very different in terms of the needs that they address. And perhaps you can talk about that a little bit.

Elaine Hochberg

It's a good question. And I'll tell you how we actually think about it. First of all, they are different disease phase, different scale, different sizes. So what we have done -- and I'll give you what our benchmarks are and the way to look at it. When we think of Linzess, we think of Zelnorm. When we think of Tudorza, we think of how did Symbicort compete against Advair, a low entrenched competitor. And those are our relevant markers because they calibrate category disease state and uptake.

Liav Abraham - Citigroup Inc, Research Division

And it's important to note that Zelnorm was a first-to-market -- when it was launched about 10 years ago, it was a first-to-market drug for treating constipation whereas Symbicort, the researcher [ph] drug, was the second-to-market drug for treating COPD. So it's important to bear that in mind, perhaps you want to elaborate on that.

Elaine Hochberg

So I'll go one step further. So as we look at that and we modeled our own coming to market with Linzess, a category that we believe has a lot of unmet needs. OTCs are used. You know that there are other drugs like the PEG laxatives, as well as Amitiza. None of them work exactly the way Linzess does. Linzess deals not only with constipation but also additional symptomatology, particularly pain and the IBS-C market. So when we look at that constellation, which is probably even superior to Zelnorm, but Zelnorm was 10 years ago and the market was different at that time. And because of some of the concerns about Zelnorm and a lot of OTC usage, when we modeled it, we did expect that within the first year, we would be somewhere in the high, what, 80% to 90% penetration of Zelnorm, and we're performing exactly as that. So when I say it's our relevant marker, we had identified it before, now we're in market and we're watching our drug perform relative to our expectations according to the Zelnorm model, given 10 years later and a different construct somewhat. If you think of Tudorza and the second-to-market phenomenon against a well-entrenched competitor, we are actually performing at more to lined [ph] time period better than Symbicort did against Advair. That makes us, again, very encouraged about how the market in these early stages, even before managed care was fully developed and even before our field force had done much of the frequency that they need to really penetrate the doctors' understanding of the drug and how to apply it, it's a very good harbinger of what we think is yet to come.

Liav Abraham - Citigroup Inc, Research Division

And just focusing on Tudorza a little bit further, the prescribing community there is -- they're both pulmonologists and primary care physicians. Can you talk a little bit about how you're penetrating the market? The primary care physicians comprise a much larger prescribing group. Where are you seeing traction at the moment? How -- who are the early adopters and how do you plan on increasing penetration in the broader primary care of prescribing group?

Elaine Hochberg

So of course, we build our launch plans to take into account both primary care and specialty. What I'll tell you in terms of performance right now is, obviously, our share with pulmonologists, a smaller audience, is very high. It's a multiple of the national. And primary care is normally -- falls behind it, but both are robust. If I look at volume of prescriptions, it's about 50-50. So it's -- actual prescriptions are being generated by both cohorts, so it says to me that the market is behaving exactly as we would identify. Specialists, pulmonologists they're only a small cadre we're talking about, less than 5,000. Primary care, we're talking somewhere about, in terms of our call plan, somewhere between 65,000 and 75,000 physicians or more. We probably haven't done as much frequency yet with all of those primary care physicians, albeit the highest performing ones are probably on par with the gastroenterologist. So it looks like we're covering them well, but we are performing against plan appropriate. And when I looked at those volumes and share penetration it's exactly where it should be.

Liav Abraham - Citigroup Inc, Research Division

Great. Perhaps looping Frank into the conversation, all of this great marketing activity leads us to perhaps talk about sales force and about costs, so SG&A expenses. Perhaps you want to talk a little bit about how your sales force is configured, and how you -- that translates into cost and how you think about SG&A expenses as these launches progress?

Francis I. Perier

Yes. It's a great question. This is like a high-class problem to have in that, we've got a very large, now, portfolio of very young-in-the-life-cycle products. We've been talking about Tudorza and Linzess, but let's not forget that we just, 12 months ago, launched Viibryd and Daliresp as well as Teflaro in the market. And we continue to drive Bystolic at 20% growth rate a year, 5 years on the market. So again, all those products require a significant commercial effort to drive them towards their potential. And that's really what we're trying to do. So I think the thing to keep in mind is that in our current fiscal year, we've guided to the fact where it's ended at $1.6 billion on SG&A. And that fiscal year will encompass really 1 quarter of launch costs for Tudorza and Linzess. And as we look out to fiscal '14, I'm not giving guidance, I'm just giving people something to think about, you've got to annualize that. We have likely, at least, 2 products -- 2 more products to launch in fiscal '14. And we've talked about the fact that we're considering whether we need to add some incremental field sales reps as well in kind of that 200 to 300 range.

Liav Abraham - Citigroup Inc, Research Division

And that would be on a contract basis?

Elaine Hochberg

To be determined.

Francis I. Perier

To be determined, whether -- they may be contract or they may just bring them onboard. So those are kind of the dynamics that we're dealing with from a planning standpoint as we've got all the products to the market. We're commercially pushing on it. They are performing very well in the market and so we need to invest appropriately behind those products.

Elaine Hochberg

Can I just add something to that?

Liav Abraham - Citigroup Inc, Research Division

Yes, sure.

Elaine Hochberg

I think it's important, since this is one of the first times I'm in front of such a forum, to talk about our philosophy about field forces. I came to Forest maybe about 15, 16 years ago from big pharma. And I came from a generation where more is always better: add on more reps, get more voice, share of voice for share of market. I will tell you that's not exactly where we are or where we have been evolving to over the last 10 years. Data in the industry is better, about what doctors' respond. There's been a lot of consolidation, doctors into group practices, looking at that, looking at the payer. We have a fairly sophisticated data management and analytics group that allows us, now, to launch to primary care not with field forces of 2,500, 2,700, but 1,200, 1,300. In fact, the launches that I am doing right now, that have got that remarkable 2,000 doctors a week, is done with half the size of a sales force that we used to have in the old days. And I also believe that our focus on franchises is also a key to efficiency while still believing, still believing in a personal promotion model. The same way I'm -- though I can't see your eyes, I'm looking at you today and you're hearing from me in person, I still believe that to transmit messages to doctors about medicines requires a combination of in person, as well as remotely personal type of techniques. So when we talk about field forces, there's a great deal of sophistication and a tremendous amount of management that goes in to nimbly apply it and move it. And in these franchises, just imagine the efficiency of being able to talk about a disease state and offering to a physician within that disease state, not 1 option but 2, maybe even 3. Think of my respiratory franchise. I now go in and talk about COPD and I could talk about moderate to severe disease when you're looking for bronchodilation. I can talk about severe disease and you really are worried about exacerbation and need to add to it. And that will only be augmented when I get a combination drug. So when we say to you, "What's the evolution of the field force and what are the numbers of the expansion?" It's not such straightforward an answer as it was in the old days where more was better. This is surgically applied, adeptly managed, it's a function of your product line and what kind of efficiencies you can get there and there are untold efficiencies. If you look at, right now, what's happening with Tudorza and Daliresp, the fact that Daliresp didn't plummet during the launch of a new product, which historically was the old model, but more or less stayed stable in the period says that there is equity in this concept, particularly when the new things is getting most of the dialogue. And you could imagine, a LAMA, a new device is almost the only thing a doctor would like to talk about. Yet our ability to talk about it, our franchise still allows Daliresp to get its due, and as we go forward, only more so because it will help doctors truly identify the patient type that they struggle so often to do in their practice. So that's the philosophical point of view. I figured I'd give it to you. Do with it what you will but it's an important, I think, concept because that's how we work.

Liav Abraham - Citigroup Inc, Research Division

And you mentioned in your comment, you did bring up an important pipeline drug and an additional -- in addition to your -- or potential addition to your researchee franchise. And that is the LABA/LAMA where we expect a Phase III data in calendar Q2, so some time within the next few months or so. Can you just talk a little bit about that? Where you stand? What your thoughts are? It's just -- there are some other players in the space that just came about. How you feel towards the -- how you feel with those positioned in the space and perhaps about the LABA/LAMA state as a whole, as a new therapeutic area for the treatment of COPD?

Elaine Hochberg

Sure. Some of you may have heard me talk about this before. I'm actually very excited about what's happening in the category. And I think the fact that there are other players bodes very well for several things. One, I think it bodes well for the medical paradigm moving. For those of you that have probably done research in the space, you well know that there is a thought about LAMA's becoming the mainstay of fundamental therapy in COPD. And potentially, the combinations of LABA/LAMAs becoming then the second add-on product, which would push out the current paradigm, which has been defined for a number of years, really, by a very good drug, Advair, as the equity, to maybe possibly later in the disease state. I think more companies coming on with those kinds of drugs and educating the medical community about the benefits of this new mechanism, alone or in combination, will change paradigm and possibly also help us penetrate earlier parts of the disease state. Right now, there are about 12 million, slightly growing 2% a year, people with COPD. About 6 million people are driving most of the utilization, and they tend to be more at the back end of the disease state, very typical. We know this even from Alzheimer's, where earlier disease is less identified and less treated, so I do believe that with more drugs in the space, more people talking about it in the space, doctors will not only identify more patients, but they'll identify them sooner, which will also lift the word of line to everyone. And I think we're well positioned. I think our product is lovely. It seems to be doing exactly what we thought it would do in marketplace. And when we get our combination, very much like with Benicar and Benicar HCTZ, having both will let more doctors start on the singleton and go to the doubleton as that paradigm moves. And I think it will compete very appropriately for the right types of patients even with the competitive set. I came out of companies that had launched anti-depressants before I came to Forest, and it was very interesting watching over the 20 years or so that, that was happening, that as more drugs piled on, it actually increased utilization. And I believe much of it appropriately so in helping doctors identify patients and how to appropriately use. And when that armamentarium is rich it allows, I think, the full manifestation, the depth of pharmaceutical therapy and medical practice treatment.

Liav Abraham - Citigroup Inc, Research Division

And in terms of catalysts and timelines, we're going to see the sort of Phase III at least headline data as we did Q2 this year -- your calendar Q2 this year. What are your timelines in terms of filing and getting that drug to market and augmenting your researchee portfolio?

Francis I. Perier

The plan is, Liav, that we'll release the Phase III top line results probably around the mid-calendar year. That puts us in a position to file the NDA for the combination program for Tudorza and formoterol right around probably the beginning of next calendar year. And you've got basically a 12-month review cycle so that would put us into the market in calendar -- beginning of calendar '16. And I think competitively that we are in a pretty good spot. We like our program. And as we look at the other programs that are under development, one of the things that I think we bring is that we're probably the only program that I am aware of that is using 2 approved drugs at their approved doses, in an approved way.

Liav Abraham - Citigroup Inc, Research Division

That's an important point because one of the -- some of the feedback that we've been receiving -- early feedback we've been receiving on this device that you're talking about and the device is being used with Tudorza is that patients love it. Perhaps you want to say a few words about that Elaine or Frank.

Elaine Hochberg

Well, I think the danger here is that Tudorza story isn't only about the device. But of course, the device is lovely. And I have father, actually, whose a COPD-er and has been on the other product for a long time. And it's interesting, he's very frail. He has a hard time loading, he gets it wrong. He needs a caregiver to come in. And I told him that this drug was coming and it's the first thing he should talk to his doctor about. So in terms of being an eyewitness, watching someone who wasn't able to self medicate, really to be able to begin to do that is really very heartwarming. And I think that, that will be relevant to a certain segment of the population. Of course, like anything, anybody whose bought a piece of furniture from Ikea knows that the instructions aren't always the most easily understood by everyone. But I think what we have with doctors and the individuals in their office who are teaching patients it's going very, very well. And I think it helps, that aids and abets that conversation with patients.

Francis I. Perier

And I think that, first and foremost, we have a drug that's very effective.

Elaine Hochberg

Right. That's correct.

Francis I. Perier

Very well tolerated and the anecdotal feedback that we're getting from the sales force and some physicians is that the BID dosing is not an issue. There is -- in fact, there is a certain element coming out and you kind of heard this that the Advisory Committee meeting, when the drug was reviewed by the FDA that, that second nighttime dose, they actually benefit patients not these traction for compliance.

Elaine Hochberg

Did that answer your question?

Liav Abraham - Citigroup Inc, Research Division

It did. Speaking of -- I would -- just taking the conversation again back to costs and to cash generation and to your balance sheet. I'd be interested, Frank, in your thoughts as you're spending on SG&A, as you're spending on R&D, you're thoughts on you still have a large amount of cash on your balance sheet. Your thoughts around capital allocation and your priorities for capital allocation given where the business is going and given your -- the strategy that you have laid out, what are your thoughts on that over the next 12 to 24 months?

Francis I. Perier

Sure. It's a great question. And historically, we were generating $1 billion of free cash flow a year. We did that for many years and that's where our capital has come from. We've also reinvested a significant portion of that cash flow back into the business over the last 5- to 6-year time frame. And we also returned a significant amount of that capital back to shareholders through share repurchase. In the current year, we've really pulled back on the share repurchase program as we go through the readjustment period of fiscal '13. And as we're going through the planning for fiscal '14 and forward, again, we think we're in a pretty good spot where we've got very good products. They're performing well with, hopefully, at least 2 more coming next year, maybe 3. And so as we're going through the capital allocation process, we really largely directed everything towards business development and we invested back into the business in the current year. I think you'll see us start to evolve more back to -- business development will probably still be the first priority, but we'll get back to taking care of our shareholders as the #2 priority.

Liav Abraham - Citigroup Inc, Research Division

What are your thoughts around business development and what are your -- you have done a lot in-licensing in the past, you've done acquisitions as well. What are your target criteria or your criteria for target acquisitions or deals that you're look at?

Francis I. Perier

Yes. I think that we still see a very vibrant market for business opportunities. I mean, our business development group, it's relatively small but it's very productive. And they look at, on any -- just this past year, they probably looked at 500 different individual opportunities. And in any given year, that will cull down to maybe the 2 to 3 kind of deals that we do a year. And we continue to look for, obviously, products that will fit into our therapeutic franchises because we get great commercial leverage out of that as Elaine just alluded to. And we're in 6 therapeutic written categories, so that gives us kind of a wide range of opportunities to look at. We're also very interested in a controlled manner, expanding our international presence as well. And I'd say that in Europe, we're not trying to replicate the U.S. primary care kind of focus model that we have because that model doesn't really play so well with European players today. We're more focused on kind of specialty products. We've started to build a specialty business around a cystic fibrosis franchise that we had for many years in the U.K. and Ireland and we expanded that to Northern Europe with a small acquisition we'd been brewing [ph] for a couple of years ago. And then building that on the back of Colobreathe, which is a DPI inhaler we just got approved in Europe. So European models, very different but we're looking at extending that as well, as well as the Canadian and as well as the American model. So we're trying to expand our footprint internationally, but not losing sight on still what is arguably -- will always be the largest, most productive and highest-valued market in the world, that being the U.S. pharmaceutical market.

Liav Abraham - Citigroup Inc, Research Division

We just have a few minutes left before I open it up to questions. Elaine, we spoke a lot about Linzess and Tudorza, your 2 main launches, but perhaps you want to address some of the other products in your portfolio and how they -- what you've been seeing there in terms of recent script trends following Q3, which perhaps is a little lower than expectations? What are you seeing in terms of the pickup there in the last quarter?

Elaine Hochberg

Well, as I mentioned a little bit earlier, when we launch drugs, we always expect the in-line products that come behind those drugs to go through a little bit of a flattening period, if not a -- sometimes a fall back and then fall forward. And so we're very pleased actually when we look at Bystolic, we look at even Viibryd. I know there has been some consternation in the market about it being relatively flat. But frankly, it wasn't unanticipated for them to launch with the new drugs; Viibryd behind the Linzess launch, Bystolic is behind the respiratory launch. The fact that we set out to try to keep them as stable as possible this period for us, was built in to the philosophy so that we weren't necessarily taking 3 steps back trying to go 3 steps forward. So when we look at the overall portfolio, heavy in the early launch period, we're actually pretty pleased with what we're seeing. And we do believe that as the sales force gains the experience of managing the new products alongside of the established products, that you'll begin to see that full robust effect of the full portfolio at play. So right now, we believe we're on target across the board. And the mend up [ph], of course, this is a question, I guess, last year when you look into the most recent weeks and retail remained stable and long-term care is coming back, even with the changes in that environment relative to short-cycle prescribing, which was really connected to decrease waste and therefore limit sale, whether you look at it on a prescription basis, which of course is a multiplier, but then you look at it on a capita basis, we're going in the right direction.

Liav Abraham - Citigroup Inc, Research Division

Any questions from the audience?

Unknown Analyst

You discussed the aclidinium/formoterol combo, obviously, there's a lot of investor interest there. Can you highlight 1 or 2 aspects that you think either the market under-appreciates as it's further along in their sort of development cycle or the commercial potential is misunderstood in CPA [ph] ?

Francis I. Perier

Well, I would say that I think there's 2 franchise that people should -- could think a little bit more broadly about. I think both of them involve life cycle management program. In the respiratory franchise, I mean, if you think about the respiratory franchise and treating the disease state of COPD, with Tudorza on the market with, hopefully, the potential approval of the Tudorza/formoterol combination and Daliresp, I mean, we have a portfolio of products that treat COPD disease state basically from beginning to end. And that, collectively, that is a very big high potential franchise for our company, and all 3 of those products being essentially as promoted by the same field force to the same position. You also -- I'm not sure that everybody kind of -- and again, I put out the point about BID versus QD for Tudorza and Tudodrza/formoterol in that all the information we are getting back from the field right now is that there is no disadvantage in there and they see the potential for advantage. So I think that the respiratory space is certainly underappreciated. And I am not sure that everybody is focused on hypertension either, in that Bystolic -- it's a $450 million a year product [ph], year 5 in the market. It's the only promoted beta blocker in an enormous category of hypertensions. And with the Bystolic/valsartan program, which we'll report out right about mid-year -- mid-calendar year this year as well, we will poise to file a very unique and novel combination program with the FDA, hopefully, right at the beginning of next calendar year as well. So that -- and again, if you think about that just like with Benicar and Benicar HCT, we had hydrochlothiazide for the program, it didn't cannibalize -- the HCT didn't cannibalize the base franchise, it actually expanded the base franchise because, as Elaine said, doctors they'll go to you because then they know they have treatment alternatives that if they need a new combination they can add on. So there's a big expansion opportunity for that hypertension category as well. And I have to mention Linzess because, again, everybody -- I think there's a high appreciation for Linzess, but I think we're very pleased with where we are on our launch and the trajectory of this product is off the blocks.

Liav Abraham - Citigroup Inc, Research Division

Perhaps we just have about 30 seconds left. You've mentioned some of the catalysts over the next -- of the immediate future, perhaps, Frank, you want to summarize some of the main data points and catalysts for Forest for the next 12 months.

Francis I. Perier

Yes. So we have -- as we were just talking, the 2 combination trials are coming up in this coming quarter. So that's the Tudorza/formoterol trial, along with the Bystolic and valsartan trial.

Francis I. Perier

Well, next quarter.

Frank J. Murdolo

Well, it's coming -- this coming, yes, the second calendar quarter. And then later in the year, we have the PDUFA date coming up for both the cariprazine filing and the levomilnacipran. So those are your basic 4 catalytic events coming up this calendar year.

Liav Abraham - Citigroup Inc, Research Division

And you mentioned Namenda XR.

Frank J. Murdolo

And Namenda XR, of course, absolutely.

Liav Abraham - Citigroup Inc, Research Division

Great. Well this has been fantastic. Thanks so much for joining us and we appreciate your comments and your thoughts.

Francis I. Perier

Thank you. Have a good day, everyone.

Frank J. Murdolo

Thank you, Liav.

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