Michael Aberman - Vice President of Strategy & Investor Relations Leonard S. Schleifer - Co-Founder, Chief Executive Officer, President, Executive Director and Ex Officio Member of Technology Committee George D. Yancopoulos - Chief Scientific Officer, Executive Vice President, Director, Ex Officio Member of Technology Committee and President of Regeneron Research Laboratories Robert J. Terifay - Senior Vice President of Commercial Robert E. Landry - Chief Financial Officer and Senior Vice President of Finance

Ying Huang - BofA Merrill Lynch, Research Division Matthew Roden - UBS Investment Bank, Research Division Jeremiah Shepard - Crédit Suisse AG, Research Division Robyn S. Karnauskas - Deutsche Bank AG, Research Division Matthew Kelsey Harrison - Morgan Stanley, Research Division Christopher J. Raymond - Robert W. Baird & Co. Incorporated, Research Division Adnan S. Butt - RBC Capital Markets, LLC, Research Division Yaron Werber - Citigroup Inc, Research Division Terence C. Flynn - Goldman Sachs Group Inc., Research Division Cory William Kasimov - JP Morgan Chase & Co, Research Division Geoffrey C. Meacham - Barclays Capital, Research Division Philip Nadeau - Cowen and Company, LLC, Research Division James William Birchenough - BMO Capital Markets U.S. John L. Newman - Canaccord Genuity, Research Division

Good day, ladies and gentlemen. Welcome to the Regeneron Pharmaceuticals Q4 2014 Earnings Conference Call. [Operator Instructions] As a reminder, today's conference is being recorded. I would now like to introduce your host for this conference call, Dr. Michael Aberman, Senior Vice President of Strategy and Investor Relations. You may begin.

Thank you, operator. Good morning, and welcome to Regeneron Pharmaceuticals Fourth Quarter and Year End 2014 Conference Call. An archive of this webcast will be available on our website under Events and Presentations for 30 days. Joining me on the call today are Dr. Leonard Schleifer, Founder, President and Chief Executive Officer; George Yancopoulos, Founding Scientist, President of Regeneron Laboratories and Chief Scientific Officer; Bob Terifay, Senior Vice President of Commercial; and Bob Landry, Chief Financial Officer. After our prepared remarks, we will open the call for Q&A. I would also like to remind you that remarks made on this call include forward-looking statements about Regeneron. Such statements may include, but are not limited to, those related to Regeneron and its products and business, sales and expense forecast, financial forecast, development programs, collaborations, finances, regulatory matters, intellectual property and competition. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in such statements. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission or SEC, including its Form 10-Q for the quarter ended September 30, 2014 and Form 10-K for the year ended December 31, 2014, which is expected to be filed with the SEC later this week. Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events or otherwise. In addition, please note that GAAP and non-GAAP measures will be discussed on today's call. Information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP are available in our financial results press release, which can be accessed on our website at www.regeneron.com. Once our call concludes, the IR team will be available to answer further questions. With that, let me turn the call over to our President and Chief Executive Officer, Dr. Len Schleifer.

Thanks, Michael. And although as a small part, it was a part the way you read that forward-looking statements did contribute to Michael's recent promotion to Senior Vice President. So Michael, congratulations. Anyway, very good morning to everyone who has joined us on the call and webcast today. 2014 was another great year for Regeneron. As many of you know, we founded this company more than 25 years ago with a simple but challenging goal, to build a company that can consistently and repeatedly bring important new medicines to patients in need. With the potential approval of PRALUENT or PCSK9 antibody later this year, maturation of our antibody pipeline and continued growth of our flagship product, EYLEA, we believe now is the time where our vision increasingly becomes reality. Regeneron is evolving into a company with the potential for multiple significant revenue streams across a variety of therapeutic areas. To that end, last month, Regeneron and Sanofi announced that our regulatory applications for PRALUENT were accepted for review by the U.S. and EU authorities. We have been granted a Priority Review in the U.S. with a PDUFA date of July 24 of this year. Pending FDA review, we look forward to potentially being the first to bring the promise of this exciting new class of therapy to people with hypercholesterolemia. We are working very closely with Sanofi to prepare for a successful launch in the second half of this year. In addition to a very exciting year for our PRALUENT program, we also anticipate reporting new Phase III results for sarilumab, our IL-6 receptor antibody for rheumatoid arthritis and submitting a U.S. regulatory application later this year. We also continue to make strong progress with dupilumab, our IL-4/IL-13 blocking antibody in a number of serious allergic diseases. We have an…

Thank you, Len, and a very good morning to everyone who has joined us today. I echo Len's sentiments that we are at a transformational stage in our company's history. From an R&D perspective, we had a landmark year of pipeline progress. We are poised to make significant strides in a variety of therapeutic areas. I'd like to begin with EYLEA and our retinal franchise. In March, we look forward to U.S. FDA action on our supplementary BLA for EYLEA in diabetic retinopathy in patients with DME. As you'll recall, we're received Breakthrough status and Priority Review for this indication, given the strong prospective results seen in a subset of patients with diabetic retinopathy in our VIVID and VISTA Phase III DME trials. Len mentioned the results from an NIH-sponsored DME study called Protocol T, that looked at the comparative safety and efficacy of EYLEA versus ranibizumab and bevacizumab. We are very encouraged by the data. In this study, EYLEA showed significant gains in efficacy when compared to both alternative therapies. We look forward to the full data publication and presentation by the DRCR, which we anticipate in the near future. We continue to invest in R&D that can bolster and protect our retinal disease franchise. The initial Phase I data for EYLEA, combined with our PDGF receptor antibody, were presented for the first time just this past weekend and demonstrated our ability to safely combine the 2 compounds in a single, well-tolerated intravitreal injection. We expect to begin Phase II trials in the first half of this year. Our combination study of EYLEA co-formulated with our Ang2 antibody in a single intravitreal injection, entered Phase I development for ophthalmologic indications late last year. On PRALUENT, our PCSK9 antibody for lowering LDL-cholesterol in people with hypercholesterolemia, we submitted the BLA…

Thanks, George, and good morning, everyone. It's been a very busy time for the Regeneron commercial team. As we build on our leadership position for EYLEA injection, which recently became the #1 FDA-approved anti-VEGF therapy for retinal disease in terms of dollar sales in the United States and as we prepare for potential launch of PRALUENT or alirocumab, I'd like to begin my comments with EYLEA. Fourth quarter U.S. EYLEA net sales to distributors were $518 million, which represent a 29% increase over the fourth quarter of 2013. According to a survey of 201 retinal specialists conducted in December of 2014, the market share for EYLEA in wet AMD in the United States is higher than that for ranibizumab. FDA-approved therapies currently hold about 56% of the overall wet AMD market. EYLEA was approved by the FDA in July of 2014 for the treatment of DME. We estimate that approximately 600,000 eyes are diagnosed with essentially involved diabetic macular edema in the United States, a similar number to those with wet AMD. Of these eyes diagnosed, only a minority are currently treated with anti-VEGF therapy. Because EYLEA has been approved using the same single strength 2 milligram dose per injection for all indications, it is difficult to give you an estimate of the proportion of our sales coming specifically from DME versus wet AMD. We've made significant progress with coverage and paid claim confirmation across the payer space for EYLEA in wet AMD -- or in DME. Currently, all Medicare jurisdictions have coverage and evidence of paid claims for EYLEA in DME, and 98% of commercialize have coverage for EYLEA for DME. Market dynamics in DME could be favorably impacted when the data from the NIH DRCR Protocol T comparative safety and efficacy study of the VEGF inhibitors are publicly…

Thanks, Bob, and good morning to everyone who has joined us today. Overall, we are pleased with both our fourth quarter and full year 2014 performance. In the fourth quarter 2014, we earned $2.79 per diluted share from non-GAAP net income of $328 million. And for the full year 2014, we earned $10 per diluted share from non-GAAP net income of $1.18 billion. This represents growth in non-GAAP diluted EPS and net income of 25% and 27%, respectively, for the fourth quarter and 22% and 26%, respectively, for the full year of 2014 compared to the same periods of 2013. Regeneron's 2014 non-GAAP net income excludes noncash share-based compensation expense, noncash interest expense related to our senior convertible notes, loss on extinguishment of debt in connection with conversions of a portion of our convertible notes during 2014, a third quarter incremental charge related to our branded prescription drug fee and income tax expense. A full reconciliation of GAAP to non-GAAP earnings is set out in our earnings release. Total revenue in the fourth quarter were $802 million and $2.82 billion for the full year of 2014, which represented growth of 31% for the 3 months and 34% for the full year. Net product sales were $522 million in the fourth quarter and $1.75 billion for the full year of 2014 compared to $406 million in the fourth quarter and $1.43 billion for the full year of 2013. EYLEA net product sales in the United States were $518 million in the fourth quarter and $1.74 billion for the full year of 2014 compared to $402 million in the fourth quarter and $1.41 billion for the full year 2013, which represented an increase of 29% and 23%, respectively. There was a modest increase in U.S. EYLEA distributory inventory levels as compared to…

Thank you, Bob. That concludes our prepared remarks. We now like to open the call to Q&A. As we like to give as many people a chance to ask questions as possible, we request that you limit yourself to one question. Our IR team, which is now back to full strength, as Manisha is back, and includes Colleen Mackey, will be available in our office after the call for follow-up questions. Thank you, and operator, please, open the call for questions.

[Operator Instructions] Our first question comes from Ying Huang with Bank of America.

So first of all, can you share little bit thought behind your 2015 guidance. It seems that, finally, the branded Lucentis and EYLEA have now more than 50% share of patients with AMD, and also you have achieved higher share than Lucentis. So shall we expect EYLEA to grow more than the market in AMD segment? And then, for DME segment this year, are you providing any patient assistance, given that there is a bigger component for commercial insurance here? And do you think Protocol T will be the drivers for 2015 DME growth?

How many questions you got, Ying?

Anymore, you -- we want to get them all before we don't answer them. Bob, maybe you can start with the assistance with DME.

Yes. So in terms of patient assistance, if someone is a commercial patient, we do offer assistance to patients for -- if they have no insurance, we offer free goods. And if they have insurance, but they have a co-pay that they cannot afford, we do offer co-pay assistance. In terms of government-pay patients, we do provide a funding to foundations, who can help patients with their co-pay if there are government-paid patients.

Okay, great. And as far as our forecast, Ying, our forecast is what it is. As you know, the science of forecasting is not the strongest science in the world. Just look what's been going on with the storm of the century that was supposed to hit New York but hit Boston. Forecasting is a tough business, but our growth forecast of 25% to 30% represent our best estimates as of today. Next question, Mike.

Our next question comes from Matt Roden with UBS.

I think Yogi Berra has said that he hates to make predictions, especially about the future. And so, with that, I want to also ask about the guidance, just put a little bit more meat on the bone. So the top end of the range, we calculated, that represents about 9% growth over the annualized 4Q sales of $518 million, where you say that the inventory range is normal. This implies also sequential growth at the top end of the range throughout 2015 of about 3.5% per quarter, and that's obviously, a slowdown from the 7% average last year. And now you have the full year DME and you have the Protocol T data behind you, so I'm just trying to understand why, philosophically, there should be a slowdown? I think that we, in consensus, might have thought that it's going to go the other way. So any additional color you can add would be helpful.

Yes. So a couple of things. First of all, the actual growth rate is going to be higher this year over last year versus last year over the year before. We grew at 22% in 2014, and we expect to grow between 25% to 30% this year. We recognize that some of those points you mentioned are forks in the road and we're going to stick with what Yogi said when you get to those forks, you should take them. And we're going to onto the next question.

Our next question comes from Jason Kantor with Crédit Suisse. Jeremiah Shepard - Crédit Suisse AG, Research Division: This is Jeremiah in for Jason. In kind of -- in going to the trajectory for DME, how do you see that shaping up for 2015? Do you expect more slow and steady growth rate? Or is it more -- do you kind of see more a step up at some point? And also regarding the Protocol T study, besides the direct comparison with Avastin and Lucentis, will you be able to speak to new patient subsets? Any marketing efforts that warrant adequate study than previous studies?

Bob, do you want to handle it?

Well, starting with the Protocol T, obviously, that is not going to be in our labeling. So from a promotion perspective, my sales reps are not going to be able to speak to specifics subsets. As you know in the retinal community, however, there are a number of presentations each year at medical meetings, and so there will be medically relevant discussions of Protocol T. But right now, we can't talk about anything specific to Protocol T until it's presented publicly. In terms of the DME growth, as we pointed out last quarter, the DME market is a little different than the wet AMD market. It's not a market where there is an urgency to immediately treat patients with the most aggressive therapy, given that the threat to vision is slower. So we do expect the DME growth to be very gradual over time. And we continue to educate on the need for dilated eye exams, the need to get to a retinal specialist and results of our clinical studies are very encouraging. We do expect to see growth in DME, but it's going to be gradual.

Next question?

Our next question comes from Robyn Karnauskas with Deutsche Bank.

With all the debate, I hate asking this question because I'm nervous about your response that -- no comment, but with all the debate around pricing -- and I know you won't comment on PCSK9 pricing, but a lot of the discussions happen well ahead of the launch of Sovaldi and Harvoni, and I was wondering if you could just give some -- any color you can give us like how aggressive payers are being in those negotiations and general thoughts? And then my second one, if you want to answer it is, so dupilumab, the new PCSK9, what will be the new dupilumab? Like what's hot in the pipeline that you'd like us to focus on underneath not being talked about right now?

Okay. So in terms of pricing, Robyn, of course, we're not going to get into what discussions we have or haven't had and what pricing thoughts are in terms of any specific terms, but what we've had -- what I have said and we've all said publicly is that our goals are really not that different than the PBMs. Our goals are to try and get our product, if it's approved, to patients who could benefit from it and get it to them in a way that they can afford and have access to it. The way we get to that point may be a little bit different, perhaps, little -- incentives are a little bit different for the PBMs, whether they are looking for revenue stream purely on a discount or something like that, I don't know. That's really their business. Our business is that we would like to come up with a fair price and we would like that price to be the price that would allow patients who could benefit from our drug to get access from it. In terms of the pipeline, George, you want to comment on the price you want to point, Robyn is paying attention [ph]?

Well, we like to not focus on any one thing, but on the depth and numerous opportunities that we have -- just today, I guess, we talked about the fact that we could be into 2 additional pivotal programs by the end of the year. That's very exciting to us. Either one of those could turn out to be very, very important to patients and to us. And we would also point to our emerging effort in immuno-oncology, which has a lot of depth and is very comprehensive. And you mentioned that dupilumab could be the next PRALUENT. Yes, we are very excited by that because we see this incredible growth opportunity there, both within indications and amongst additional indications. We think that this could really be an important drug for very different assortments of allergic-related disease. And certainly the asthma data that we just announced the top line results, which was very well received at our end of Phase II meeting with the FDA, there's a lot of reason for excitement. And the fact that we'll be able to go forward with the single Phase III trial is very exciting to us.

Next question?

Our next question comes from Matthew Harrison with Morgan Stanley.

I want to ask one on the pipeline. Obviously, we saw the PDGF combo data over the weekend. You've highlighted Ang2 as an interesting compound in the past. And now that that's in the clinic and we have some sort of clinical bar in terms of the PDGF combo to look at, what sort of clinical differentiation do you think we should be looking for in terms of that Ang2 combo? And any thoughts on timing around when we might be able to see first clinical data out of that program?

George?

I guess, you are asking for differentiation between the Ang and the PDGF or versus EYLEA. I think in all of these settings, what we're looking for is either increased durability and/or some sort of functional benefit supplied by the additional agent. And so these have different biologies. There's been very interesting preclinical work with both of them. So we're looking forward to both of these. In terms of the timing of the programs, I don't think we give you too many specifics on that.

Next question, operator?

Our next question comes from Chris Raymond with Robert Baird. Christopher J. Raymond - Robert W. Baird & Co. Incorporated, Research Division: Guys, I do have a pipeline question and maybe more of a leading question since it -- yes, I think someone asked if you could highlight what you think is most exciting. There's Regeneron 1033 (sic) [ REGN1033 ], I think you talk about in your regulatory filings, but I don't think you've really talked about it too much on your calls. But as I see in -- on ClinicalTrials.gov, looks like there's a Phase II trial that should wrap up next month in sarcopenia. Could you talk a little bit about this opportunity? How should we be thinking about it? And maybe since it is sort of mid-stage, why it's not something that you guys highlight in this venue?

Well, as I said -- I mean, it's very hard to highlight 15 different programs. We have -- as you said, we have proof-of-concept data coming out with this GDF8 antibody that you refer to that could be important for overcoming muscle atrophy in a variety of settings. And I guess we're going to wait for the proof-of-concept data to decide next steps and how exciting it will be. But I think what we're really excited about is the depth and the breadth of all of our programs having 15 antibodies and the fact that so many of them are addressing important unmet needs and could be making such important differences in patients' lives.

Yes, just a add to that -- I mean, even though there is individual programs, 15 different ones, some of them go across multiple disease areas, obviously. And some of those potentially, as George has talked about in other forms, represent franchise opportunities. So, for example, the Bispecifics that George and team have now realized in terms of making them and putting them into clinical trials, if we can get that franchise going, there's some real opportunity for us to become real leaders in the field of immuno-oncology because, obviously, you can use a plug-and-play strategy there, where the first one maybe targeting CD20, but the others could target whatever target you might be interested in. And some of that will be part of work we do with Sanofi. So we're actually pretty excited about -- just one of these represent another whole order of magnitude or franchise behind it.

Next question?

Our next question comes from Adnan Butt with RBC Capital Markets.

So the one question I'd like to ask is that in terms of Regeneron's participation in the commercial infrastructure, would you be breaking out details? And in terms of deciding which projects to participate in, is that a project by project decision? Or will you be in sarilumab and dupilumab as well?

So we actually make a project by project decision, and we have not announced our decision for sarilumab and dupilumab at the current time. Michael?

Next question?

Our next question comes from Yaron Werber with Citi.

Quick question on your 222 (sic) [ 2222 ] antibody, the anti-RSV, give us a little bit of a sense. Is this going -- is this ready to move into kids? And is this looking at prevention? And how is it differentiated from synergies?

Well, as we said, we're talking about moving into a pivotal trial this year here for this program. And that, of course, will be in children. And we think that it could be quite differentiated from the existing treatments out there. In terms of the -- which populations are actually targeted, the number of treatments that might have to be given to cover the individuals and also potentially the extent of the efficacy. So we're quite excited about this program.

I mean, usually, when you move into kids, you got to do sort of a challenge first, but this is an antibody. So it sounds to me like you don't feel like you need to do a challenge, whereas you can go right and do a pivotal for kids.

Well, we of course have been discussing and dealing with the FDA on all of this. And when we move forward, it's all with the -- with all these communications and discussions with the FDA.

Thank you, Yaron. Next question?

Our next question comes from Terence Flynn with Goldman Sachs.

Maybe just one clarification and one question. So with respect to Matt's question on the EYLEA guidance. Can you just clarify if favorable Protocol T data is actually factored into your guidance? Or if that's something that you would consider once we see the full data? And then on dupilumab, I was just wondering if you can share any more details on the pediatric programs for atopic dermatitis, if that would actually be a registration-enabling trial or if you're talking more of kind of a PK/PD program first before you go into a registration trial.

So in terms of Protocol T and our guidance, everything we know that kind of went into the mix and what came out was our best guess. But obviously, until we see how -- we're very excited about Protocol T, but till we see how it gets received and how quickly might or might not influence behavior, we hope it will, things could change. So it's our best information, I guess, on the future that we have as of the moment. The second question, I don't think that the first trial in pediatric atopic dermatitis will be a pivotal trial. But of course, we are in a full blown pivotal program right now with multiple Phase III trials going on in parallel and rolling well in atopic dermatitis. We're very, very pleased with how that program is getting kicked off. It's just a recent start. And obviously, we are going into pediatrics with the hope of eventually getting a label in that age group as well because there are a lot of kids there that are -- could potentially benefit.

Don't forget we have Breakthrough status. So obviously, we're going to work closely with the FDA and take full advantage of what that affords us. Next question?

Our next question comes from Cory Kasimov with JPMorgan. Cory William Kasimov - JP Morgan Chase & Co, Research Division: I wanted to follow-up on dupilumab. For that program in asthma, so now that the FDA considers the Phase IIb sufficient to be a pivotal study, is it safe to assume that the single Phase III trial will be designed in a very similar fashion, just more centers and more patients?

George?

Yes. I guess -- as you said, everything you said, makes sense.

We won't go into specifics, but I'll...

We try not to take additional risk, obviously, in these programs. Next question?

Our next question comes from Geoff Meacham with Barclays.

I know you're, obviously, not getting specifics for DME for guidance, but I just want to get some color from you all on market dynamics since the launch in DME and things like treatment experience of new starts? And then on the R&D side, there are a lot of disruptive therapies on the horizon and retinal that are frequent intravitreal injection like gene therapies, subcu, things like that. How are you guys thinking about these approaches when you prioritize your pipeline in retinal?

Right. So to answer the question, Geoff -- I am glad to hear you at your new forum, good luck. In terms of -- Bob, you want to take the first question?

Yes. As I said, Geoff, it's hard to tease out the DME portion of our business relative to the AMD business. We are seeing a pickup in reported usage in DME, but I can't give a precise market share right now.

And so -- and in terms of, Geoff, your question about R&D, there is a lot going on in the R&D world. We are obviously in it. You've heard about -- George talk about our PDGF program. You've heard him talk about our Ang2 program. There are other things internally that we haven't talked about? We also have a collaboration with Avalanche in gene therapy. We've looked at some of the systemic programs that you talk about. Obviously, systemic inhibition of VEGF, we've known from the very earliest of early days that it's likely to be something that could work, but the question is, can it work with the right therapeutic index? We, in fact -- George, do you want to add anything to that?

Right. Our -- some of our first studies actually in the AMD field were done systemically using systemic approaches. And of course, the concern is the benefit risk with more widespread blockade. And certainly, most of us have decided that that's not going to lead to a satisfactory benefit risk. But as Len said, we are very active in this area. We consider ourselves leaders in this area. We certainly see a lot of excitement here that we don't see that any of these approaches are really going to be widespread approaches that are going to be replacing the current standard of cares. They're going to -- for at least the initial periods of time, it's going to be, we think it's including some of the areas that we're going to -- into -- addressing perhaps more niche areas that maybe perhaps over time could grow.

Great. And next question, operator?

Our next question comes from Phil Nadeau with Cowen and Company.

My question is on the Amgen lawsuit with probably -- what's the update there? What has happened over the last few months? And then looking forward, I believe Amgen has asked for you guys to be barred from the market? How is that going to be decided over the next 5 months? Is there a public hearing? Or what can we look for to see the preliminary injunction be determined?

Yes. We're not going to comment on the ongoing lawsuit, but I'm unaware that Amgen has asked for us to be barred from the market with a preliminary injunction.

Okay. Next question?

Our next question comes from Jim Birchenough, BMO Capital Markets.

Notwithstanding your comments about Yogi Berra. Can you give us some sense of how to think about the PRALUENT launch and benchmark it against other biologics launches? We've got the example of Prolia into the osteoporosis base. We've got cancer drug launches you're familiar with. How do we think about it just qualitatively, your expectations for the launch?

Qualitatively, we're hoping for a good launch. Is -- I don't know if that's going to be helpful to you, Jim, but it's really...

Well, I guess, benchmarking it, Len, against some -- probably a launch versus something that goes a little steeper like an oncology drug launch. How should we think about that?

So, Jim, I think, obviously, you've hit the nail on the head. This is a unique marketplace. We are entering a primary care type market for biologics. So I think what you can expect is that the reimbursements will go slowly and it will be a gradual build. But as Len has always said, I was wrong on EYLEA. I don't know where we're going to go with PRALUENT. And I hope I'm wrong on PRALUENT. I mean, for us, we've got our eye on the long-term, and the potential that this product has to make a difference for people who really can't get their cholesterol down and need to get their cholesterol down. If these -- if this class of product gets approved, I think it could provide a real additional -- an important addition to the therapeutic armamentarium, and that's sort of what we're focused on. And overall the long-term, if you can bring a product to market that can really makes a difference to patients, I think you have an advantage. I do believe there will be 2 parts to this launch. The first part of the launch will be what we anticipate will be the rapid adapters, people who -- whose doctors want to get in early on a new type of approach for patients who really need it, perhaps, the familial hypercholesterolemia, who -- who've had cholesterol all their lives. I think there was an interesting article that just came out in circulation that suggests that having high cholesterol is not the only thing, it's how long you've had a high cholesterol seems to really matter. It's sort of like area under the curve or pack years of smoking that seems to be driving this. And there are people out there who've had a lifetime, decades of high cholesterol for genetic reasons and no matter what they do, can't get it down. I expect there'll be early adopters in that area. There'll be others who want to wait until we outcome studies come out. And then I think you'll see a relaunch of the product. So I think this has a possibility to be a nice study, initially driven by the early adopters and the really high need. And then the outcome studies will perhaps drive another leg up. Michael, we have time for anymore?

We have one more -- we've time for one last question.

Our next question comes from John Newman with Canaccord.

I promise to only ask one. Given the -- seems like almost daily attempts to read through on the pricing situation with HPV [ph] drugs to many others products that are launching -- excuse me, is it reasonable to think that payers are going to think differently about a product with a price tag at the Harvoni level and the Sovaldi level versus a product that could have a much lower price tag?

Yes. You had more to that question or am I missing something?

And also, do you think that payers are more concerned about the individual drug cost? Or do you think that they're more concerned about just the total potential long-term cost? And that's how they're going to be thinking?

It's interesting. Not all payers are the same and not -- even within a payer, they're -- the financial incentives are not always the same in terms of which book of business that you look at. There's some big books of business where they are at risk, a payer for example or PBM. And when they're at risk, they really care about total cost because they're taking the risk and they have to bear the risk of the total expenditures. On other books of business or other PBMs, they are simply there to be a good negotiator. And actually, they are somewhat from their own bottom line, they may have a societal interest, but from their own bottom line, they have less of a concern about the absolute price than -- other than getting a discount from whatever the price may be. All that, as I said, is their business. Our business is to try and get the drug out at a fair price. And clearly, we have to take into consideration what the payers think is a fair price, but as importantly, what the doctors and the patients can believe is a fair price, what they can afford with co-pays and we want it -- we don't want to get in a situation where these products are commoditized because we think there are differences between the products. And we want to get in a situation where doctors and patients can make choices. Remember what President Obama and Dr. Yancopoulos discussed last week at the White House was precision in individualized medicine. And if you -- you can't have individualized medicine if you don't have doctors making choices for individual patients. So fundamentally, we think that's a good thing and that's where we would like to wind up. Okay, Mike?

Great. Well, thank you, everybody. This is going to conclude our call for today, and we appreciate everybody. And as I mentioned, the IR team is available for follow-up. Just send us an email or drop us a line, and we'll get [Audio Gap]

Ladies and gentlemen, that concludes today's presentation. You may now disconnect, and have a wonderful day.