Earnings Labs

Regeneron Pharmaceuticals, Inc. (REGN)

Q2 2015 Earnings Call· Tue, Aug 4, 2015

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Transcript

Executives

Management

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations Leonard S. Schleifer, M.D., Ph.D. - Founder, President, Chief Executive Officer & Director George D. Yancopoulos, M.D., Ph.D. - Founding Scientist; President, Regeneron Laboratories and Chief Scientific Officer Robert J. Terifay - Senior Vice President, Commercial Robert E. Landry - Chief Financial Officer

Analysts

Management

Ying Huang - Bank of America Merrill Lynch Terence C. Flynn - Goldman Sachs & Co. Matthew K. Harrison - Morgan Stanley & Co. LLC Mohit Bansal - Deutsche Bank Securities, Inc. Geoffrey Craig Porges - Sanford C. Bernstein & Co. LLC Adnan S. Butt - RBC Capital Markets LLC John Newman - Canaccord Genuity, Inc. Colleen Hanley - Robert W. Baird & Co. Cory W. Kasimov - JPMorgan Chase & Co. Joseph P. Schwartz - Leerink Partners LLC Gbola Amusa - Chardan Capital Markets LLC Phil M. Nadeau - Cowen & Co. LLC Geoffrey Meacham - Barclays Capital, Inc. Biren Amin - Jefferies LLC Matthew M. Roden - UBS Securities LLC

Operator

Operator

Good day ladies and gentlemen, and welcome to the Regeneron Pharmaceuticals Q2 2015 Earnings Conference Call. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Dr. Michael Aberman, Senior Vice President of Strategy and Investor Relations for Regeneron. You may begin.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Thank you very much. Good morning, and welcome to Regeneron Pharmaceuticals' second quarter 2015 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; Dr. George Yancopoulos, Founding Scientist, President of Regeneron Laboratories and Chief Scientific Officer; Bob Terifay, Senior Vice President, Commercial; and Bob Landry, Chief Financial Officer. After our prepared remarks, we'll 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 forecasts, 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 filing with the United States Securities and Exchange Commission or SEC including its Form 10-K for the year ended December 31, 2014 and Form 10-Q for the quarter ended June 30, 2015, which was filed with the SEC this morning. 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 these 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, Bob Landry and the IR team will be…

Robert J. Terifay - Senior Vice President, Commercial

Management

Thank you, George, and good morning everyone. This is a very exciting time in the history of Regeneron. Almost four years after its initial US launch, EYLEA or our aflibercept injection continues to demonstrate strong sales growth. In addition just last month, Praluent or alirocumab received US regulatory approval for the lowering of poorly controlled low density lipoprotein cholesterol in specific high-risk patient groups, and was shortly thereafter made available to patients who need it. Praluent was also given a positive recommendation by the European regulators, with EU approval expected in September. Starting this with EYLEA. Second quarter US net sales grew 58% year-over-year. Net US EYLEA sales to distributors in the second quarter were $655 million. Underlying physician demand has continued to remain strong and grew sequentially quarter-over-quarter by 19%, representing the highest sequential quarter-over-quarter growth that we've experienced since the third quarter of 2012. Market research with retinal specialists indicates that a key driver of EYLEA growth in the second quarter is the continued positive impact of the results of the Protocol T study in patients with diabetic macular edema or DME. As a reminder, this independent NIH-sponsored study explored the comparative effectiveness of EYLEA with ranibizumab and off-label bevacizumab and demonstrated that EYLEA provided greater efficacy despite one fewer injection and fewer laser treatments. The efficacy differences were particularly pronounced in the pre-specified group of patients whose vision was worse at study initiation. This group represents about 50% of all DME patients. These data have been viewed very positively by physicians and payers and were one of the biggest drivers of strong EYLEA growth in the second quarter. According to a survey of 200 retinal specialists evaluating the reported usage of VEGF inhibitors in the second quarter of 2015 as well as a chart audit from 183…

Robert E. Landry - Chief Financial Officer

Management

Thanks, Bob, and good morning to everyone who has joined us today. Regeneron posted another strong financial performance in the second quarter of 2015 and we are very pleased with our financial results for the first half of the year. In the second quarter of 2015, we earned $2.89 per diluted share from non-GAAP net income of $338 million, which represents year-over-year growth in both non-GAAP diluted EPS and net income of 17%. Regeneron's second quarter 2015 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 the quarter and non-cash income taxes. Second quarter non-GAAP net income reflects cash income taxes expected to be paid or payable for 2015. A full reconciliation of GAAP to non-GAAP earnings is set forth in our earnings release. Total revenues in the second quarter of 2015 were $999 million, which represented year-over-year growth of 50%. Net product sales were $658 million in the second quarter of 2015 compared to $418 million in the second quarter of 2014. EYLEA net product sales in the United States were $655 million in the second quarter of 2015 compared to $415 million in the second quarter of 2014, which represents an increase of 58%. During the second quarter of 2015, EYLEA experienced a slight decrease in US distributor inventory levels as compared to the first quarter 2015 but remains within our normal one to two week targeted range. I also want to note that despite having launched almost four years ago, EYLEA experienced sequential dollar sales growth this past quarter of $114 million, the largest in the product's history. As Len mentioned earlier, we are raising our US EYLEA net sales growth guidance…

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Thank you, Bob. That concludes our prepared remarks. We'd now like to open the call to Q&A. As we'd like to give as many people a chance to ask questions as possible, we request you limit yourself to one question. Bob Landry and the IR team will be available after the call for follow-up questions. Thank you. Operator, you can please open the call for questions.

Operator

Operator

Thank you. Our first question comes from the line of Ying Huang with Bank of America. Your line is open. Please go ahead.

Ying Huang - Bank of America Merrill Lynch

Analyst

Hi. Good morning, guys. Congratulations for a great quarter. The first question on the strength of EYLEA in this quarter. Bob, maybe can you give us a little bit more color in terms of whether you also see more penetration in AMD rather than just in DME and where that share is coming from? And then secondly, just a question on Praluent. CVS' CEO just said on the earnings call this morning that they plan to employ a similar strategy to the so-called formulary exclusion strategy to manage their PCSK9. So, I was wondering what's your strategy if that happens actually from the payers. And then just a housekeeping question, are you going to block the IMS subscripts for Praluent or not? Thank you.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

That was three questions, Ying. So bad instruction following. Leonard S. Schleifer, M.D., Ph.D. - Founder, President, Chief Executive Officer & Director: All right. Bob Terifay, please.

Robert J. Terifay - Senior Vice President, Commercial

Management

Well in terms of EYLEA growth, the bulk of the growth is coming in DME, both in terms of growing the DME market overall for the anti-VEGF class, as well as taking market share from both Lucentis as well as bevacizumab. We do see some growth in RVO and some slight growth in wet AMD. But the majority of the growth that we're seeing is in DME. In terms of your questions on Praluent, it's too early to talk specifically about payers, but we've always expected that the payers are going to want patients to step through maximally tolerated statin therapy in order to get access to Praluent. And that is our labeling. And so, it's not a surprise that people are advocating for patients to have been on maximally tolerated statin therapy. The IMS data, yes, we intend to utilize IMS data. So, you will see the IMS data in the audits.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Okay. Next question. Thank you.

Operator

Operator

Thank you. Our next question comes from the line of Terence Flynn with Goldman Sachs. Your line is open. Please go ahead. Terence C. Flynn - Goldman Sachs & Co.: Hi. Thanks for taking the questions. Maybe just another one on EYLEA for DME. You mentioned you're seeing new prescribers there. Are those retinal specialists or is there a broader category here? And then do you have any insight on referral trends from either ophthalmologists or endos to retinal specialists of DME patients? Thanks.

Robert J. Terifay - Senior Vice President, Commercial

Management

So, the new practices are generally smaller ophthalmology practices that were rebuying Avastin because they were not familiar with all the reimbursement techniques in terms of buy and bill. But with the recent DME data, there's more interest in utilizing EYLEA. With regards to referrals, as we've talked about on the last couple of calls, we are actively working with ophthalmologists as well as optometrists to build awareness of the need for regular screening for eye exams and to get patients to retinal specialists as soon as DME is diagnosed. And we're hoping some of the is starting to pay off.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Next question?

Operator

Operator

Thank you. Our next question comes from the line of Matthew Harrison with Morgan Stanley. Your line is open. Matthew K. Harrison - Morgan Stanley & Co. LLC: Great. Thanks for taking the question. I wanted to ask about the bispecific in the PD-1. On the past two calls you've characterized responses that you seen with those patients. I don't know if you'd be willing to give us some more detail around that. And if you're not, could you tell us when we might see that data? Is it possible to see that data at ASH this year? Thanks. George D. Yancopoulos, M.D., Ph.D. - Founding Scientist; President, Regeneron Laboratories and Chief Scientific Officer: Yeah. We're waiting for the appropriate medical conference in which to provide more detail Thanks.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Next question.

Operator

Operator

Our next question comes from the line of Robyn Karnauskas with Deutsche Bank. Your line is open.

Mohit Bansal - Deutsche Bank Securities, Inc.

Analyst · Deutsche Bank. Your line is open.

Great. Thanks for taking my question. This is Mohit filling in for Robyn. Congratulations on a great quarter. So, turning a little bit on your RSV program, could your Phase 3 trial be a pivotal trial given the plan is to enroll 24 patient in this trial? And what is the baseline risk of developing RSV in the babies you are enrolling in this trial? Thank you.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

I think you're asking about the RSV pivotal trials, whether it's Phase 3 and the last one the risk of enrolling infants or?

Mohit Bansal - Deutsche Bank Securities, Inc.

Analyst · Deutsche Bank. Your line is open.

So, the baseline risk of developing RSV in these patients. So because I mean, it seems like a natural history kind of study. That's why I am asking. George D. Yancopoulos, M.D., Ph.D. - Founding Scientist; President, Regeneron Laboratories and Chief Scientific Officer: Right. No. These are considered to be pivotal studies and we've discussed very carefully with the FDA in terms of the infant population which is in fact intended to be a somewhat broader population of infants at risk. Thank you.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Next question.

Operator

Operator

Thank you. Our next question comes from the line of Geoffrey Porges with Bernstein. Your line is open. Geoffrey Craig Porges - Sanford C. Bernstein & Co. LLC: Thanks very much. Appreciate the chance to ask a question. George, can I just throw a couple of questions to, first, on the immuno-oncology side, you mentioned both that you have opted in and will be the commercialization partner for the PD-1, but also alluded to the fact that you may have a PD-L1. Could you give us a sense of your view of the relative merits of a PD-1 and a PD-L1, because superficially you might say that that was overkill. And then just on the RSV, again could you explain where you are in terms of having a final manufacturing process to take into pivotal trials? I mean, are you there yet? Can you scale up with the process you have? George D. Yancopoulos, M.D., Ph.D. - Founding Scientist; President, Regeneron Laboratories and Chief Scientific Officer: Yeah. On the first question, we certainly feel that the signs suggest and maybe the early clinical data suggest that if anything PD-1, if anything should have somewhat broader efficacy than PD-L1. On the other hand, there may be some patients who might be able to tolerate a PD-L1 better in settings where for example, they maybe getting some toxicity due to for example inhibition of PD-L2. So we think it might be useful to have both components, but certainly we think that PD-1 should be more likely the broader foundational therapy. On the second question, yeah, we're using our standard manufacturing approach, which we've used for all of our other clinical programs for RSV. So, we think it's certainly commercializable.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Great. Next question.

Operator

Operator

Thank you. Our next question comes from the line of Adnan Butt with RBC Capital Markets. Your line is open.

Adnan S. Butt - RBC Capital Markets LLC

Analyst · RBC Capital Markets. Your line is open.

Hey. Thanks. Congrats on the solid EYLEA number as well. So first, could you comment on the scale and scope of the sampling program? Will it require the same pre-authorization process that we would be expected of a paid script? And then is there a two-year follow-up of Protocol T data as well? And is that going to be as meaningful? Thanks.

Robert J. Terifay - Senior Vice President, Commercial

Management

So in terms of the sampling, we have to obviously obtain physicians' signatures to be able to get access to the samples, but then it is up to the physician to determine which patients get access to the therapy. George D. Yancopoulos, M.D., Ph.D. - Founding Scientist; President, Regeneron Laboratories and Chief Scientific Officer: In terms of Protocol T, yes, there will be two-year data and certainly we're very interested in seeing what that data will look like.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Great. Next question.

Operator

Operator

Next question comes from the line of John Newman with Canaccord. Your line is open, please go ahead.

John Newman - Canaccord Genuity, Inc.

Analyst · Canaccord. Your line is open, please go ahead.

Hi, guys. Thanks for taking the question and I'd like to add my congrats on the EYLEA number, very strong. My question is regarding the development strategy for both PD-1 and PD-L1. We've seen a few companies around the fringes running studies in combination with – or running studies where two investigational drugs are being tested at the same time. And I'm just curious if that might be a strategy that you would discuss with the agency that could allow you to sort of maybe leapfrog some of your competition in the PD-1 and the PD-L1 space. Thanks. George D. Yancopoulos, M.D., Ph.D. - Founding Scientist; President, Regeneron Laboratories and Chief Scientific Officer: Yeah. We are certainly exploring that opportunity. We agree with you that that is frankly going to be a necessary approach for the entire field to make appropriate progress in this very complex setting. So, I'm sure that we and a lot of other people are thinking and considering that approach.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Great. Next question.

Operator

Operator

Thank you. Our next question comes from the line of Joseph Schwartz with Leerink Partners. Your line is open.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

You may be on mute, Joe. Leonard S. Schleifer, M.D., Ph.D. - Founder, President, Chief Executive Officer & Director: Joe, you might be.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Or fell asleep. Leonard S. Schleifer, M.D., Ph.D. - Founder, President, Chief Executive Officer & Director: We'll come back to Joe.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Next question.

Operator

Operator

Our next question comes from the line of Mark Schoenebaum with Evercore ISI. Your line is open.

Unknown Speaker

Analyst · Evercore ISI. Your line is open.

Hi, guys. This is John (41:10) filling in for Mark. Congrats on the quarter. Just a quick one on the RSV program, if I may. So, I think you previously mentioned the half-life of the antibody could result in, so less frequent dosing. I was wondering if you've disclosed the dosing regimen of the antibody in Phase 3. Is it in fact less frequent than Synagis? Are you doing once per season dosing? And then really fast on IO. I'm trying to better understand how the logistics of alternating the lead programs work. So, is it by order of filed INDs, or is it by when Sanofi opts in to the collaboration? And how would that work for a combination regimen? Thanks. Leonard S. Schleifer, M.D., Ph.D. - Founder, President, Chief Executive Officer & Director: Michael can take the second one. Then we'll go back to.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Yeah, that will be alternating at the time of opting in. And there is a mechanism for how to deal with combinations where you're combining two different products either in the discovery program or the license side. I don't know if I want to get into that detail. Perhaps after the call. Leonard S. Schleifer, M.D., Ph.D. - Founder, President, Chief Executive Officer & Director: But this is a good time to say that. This is Len. Our relationship with Sanofi, as George said in his opening remarks, has really been quite spectacular and has been built on many, many years of closely collaborating on every aspect of what we do, from discovery, to early development, to full development through scale up, and through commercialization now with Praluent. So I think the partners know how to work together, and this will be handled rather straight forwardly. The basic concept from your vantage point is that on half the programs, we'll be taking the lead, on half the programs they'll be taking the lead. George D. Yancopoulos, M.D., Ph.D. - Founding Scientist; President, Regeneron Laboratories and Chief Scientific Officer: Yeah, just to elaborate on what Len says, I mean, we've done it before. We're going to just do what's right for the program. And we don't necessarily follow the contract because we have such a good relationship with Sanofi. If it makes sense not to alternate as per what's in the contract, we'll do what's right for the program. In terms of RSV, yeah, we are certainly exploring less frequent dosing regimens in the pivotal studies and we have reason to believe that they might work, so we're hoping that the data might support that.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Thanks, John (43:23). Next question?

Operator

Operator

Thank you. Our next question comes from the line of Brian Skorney with Robert W. Baird. Your line is open. Please go ahead. Colleen Hanley - Robert W. Baird & Co.: Hi. This is Colleen Hanley in for Brian Skorney. Thanks for taking my questions. Two quick ones for you on Praluent. How will Praluent be distributed? Will it be through retail distributor or special channel? And you touched on this a little bit before, but do you think IMS prescription data services will be good surrogates for sales or will distribution be so selective that you can't really offer a decent capture rate? Thanks.

Robert J. Terifay - Senior Vice President, Commercial

Management

So, I'll start with the IMS, it's going – as I said earlier, it's going to take several months for us to get to a sales reporting that is reliable based upon it taking some time to get reimbursement, patients being on samples, and patients being on free product. So when the IMS data comes out later this week, it's not going to be terribly reliable. It will improve over time. But again remember, not all of the specialty pharmacies report to IMS, so some of the data are projected. So obviously, ultimately it's going to be our actual sales data that are going to be more reliable. In terms of Praluent distribution, we are distributing through a network of specialty pharmacies. Colleen Hanley - Robert W. Baird & Co.: Okay. Thank you.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Great. Good questions, the next questions please?

Operator

Operator

Thank you. The next question comes from the line of Cory Kasimov with JPMorgan. Your line is open. Cory W. Kasimov - JPMorgan Chase & Co.: Hey. Good morning, guys. Thank you for taking the questions. I wanted to ask about the IO collaboration as well. So in addition to in-house combinations, will you also be looking outside of the Regeneron and Sanofi pipelines for potential combos? And do you have any residual concerns that IP potentially becomes an issue given the land grab that's currently going on in the field? Thanks.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

I'll – the first question, the answer is yes. We will be exploring all opportunities for combinations. So I don't have specifics, but there's no reason why we couldn't look outside the collaboration for novel combinations. That said, thankfully for us, we have George and his team and we have a plethora of things to do internally. And so those will probably definitely take precedence. In terms of IP, Len? Standard answer. Leonard S. Schleifer, M.D., Ph.D. - Founder, President, Chief Executive Officer & Director: Yeah. I don't think – we look at IP very carefully. We're pretty experienced and been in the antibody IP business for a long time. And we should just leave it at that. Cory W. Kasimov - JPMorgan Chase & Co.: Okay. Thanks guys.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Next question?

Operator

Operator

Thank you. Our next question comes from the line of Joseph Schwartz with Leerink Partners. Your line is open.

Joseph P. Schwartz - Leerink Partners LLC

Analyst · Leerink Partners. Your line is open.

Thanks for coming back to me. I was wondering if you could give us some insight into what is it about the IO antibodies that you're pursuing that makes you so enthusiastic about the potential to obtain better responsiveness or safety and tolerability? Yeah, you alluded to the response rates, that it sounds like you think you can improve upon it. Is it higher affinity for the target as was the case with dupilumab, other aspects of the technology that you can offer us some insight into your approach there? George D. Yancopoulos, M.D., Ph.D. - Founding Scientist; President, Regeneron Laboratories and Chief Scientific Officer: Well, I think what's going to be required for success here is a really comprehensive approach and bringing to bear many different antibody candidates in the right settings, in the right combinations. And we have not only some of the more carefully characterized targets covered, but we also have a large number of innovative and novel targets. And we think that there's going to be a little bit of magic and maybe a certain degree of luck and a lot of science involved in figuring how to best do this. And this is what we think that we're historically strong at. So this is why we think that this is a great opportunity, because it is so early in the game here and it's going to be a complex business and the complexity I think plays to our advantages.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Next question?

Operator

Operator

Thank you. Our next question comes from the line of Gbola Amusa with Chardan Capital. Your line is open.

Gbola Amusa - Chardan Capital Markets LLC

Analyst · Chardan Capital. Your line is open.

Hi. Thank you for taking my call. Gbola Amusa from Chardan Capital. On EYLEA, on the beat, could you just confirm where dosing has gone year-over-year? We've seen for the overall market for example, dosing has gone from four per year to five to six to seven. So could you confirm that there weren't major changes there? And then secondly on your economic interest in wet AMD through gene therapy with your Avalanche stake and partnership, could you give any thoughts on the recent Phase 2a data on wet AMD? Or if it's too early for that, would you give us a sense on when we may get more visibility on your intentions with that program? Leonard S. Schleifer, M.D., Ph.D. - Founder, President, Chief Executive Officer & Director: Right. So, in terms Avalanche, Mike, you might want to comment on that.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Yeah. My comment will be, we're not going to comment on that. We'll let the process go out and you'll hear from Avalanche. Leonard S. Schleifer, M.D., Ph.D. - Founder, President, Chief Executive Officer & Director: Well, I might just remind everybody that the prime mover of the Avalanche deal for us was to get a look into gene therapy for eye diseases where there is no standard of care already and where gene therapy would be uniquely positioned as a therapeutic choice. So therefore, the risks, rewards of the programs would be greater. Nevertheless as Michael says, we will look at and review this data as we expect to.

Robert J. Terifay - Senior Vice President, Commercial

Management

In terms of EYLEA dosing, we're trending very close to what we see in our prescribing information which is dosing every eight weeks. I'll remind you, if you look at the number of doses per year in the Protocol T trial, which had a different dosing regimen, they lined up pretty closely to what we saw in our own DME studies. So physicians are generally after an initial loading dose period, able to get patients out for at least eight weeks.

Gbola Amusa - Chardan Capital Markets LLC

Analyst · Chardan Capital. Your line is open.

Okay, so -

Robert J. Terifay - Senior Vice President, Commercial

Management

No year-over-year – apologies, no year-over-year change drove the beat effectively. It was - Leonard S. Schleifer, M.D., Ph.D. - Founder, President, Chief Executive Officer & Director: So you're asking the question do we have more doses, which is driving the increase. No, we're not seeing more doses drive, per year driving net sales.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Great. And our next question.

Gbola Amusa - Chardan Capital Markets LLC

Analyst · Chardan Capital. Your line is open.

Great. Thank you.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Thanks, Gbola. Next question.

Operator

Operator

Thank you. Our next question comes from the line of Phil Nadeau with Cowen & Company. Your line is open. Phil M. Nadeau - Cowen & Co. LLC: Good morning. Thanks for taking my question. Let me add my congratulations on all the progress. Just a question on dupilumab and atopic dermatitis. In the adult pivotal program, can you remind us what you need to file? Can you file on the 16-week data, or do you need to wait for the 52-week data? And then similarly on atopic dermatitis for kids, what is the update on the pediatric development plan, and when could you start pivotal trials there? Thanks. George D. Yancopoulos, M.D., Ph.D. - Founding Scientist; President, Regeneron Laboratories and Chief Scientific Officer: So in terms of the filing, we expect to have to do the 16-week data from two of the trials, but we'll expect to have one-year data from the longer-term trial for the initial filing. So we'll have thousands of patients in that initial filing.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

The other question is pediatrics. George D. Yancopoulos, M.D., Ph.D. - Founding Scientist; President, Regeneron Laboratories and Chief Scientific Officer: Oh, pediatrics. I'm sorry. Those pediatric PK and other preparatory studies as well as getting into actual efficacy studies is really ongoing. There was a panel, a conference on this and the idea was that we should be moving sooner rather than later and not waiting for the outcome of our Phase III data to move into what can be fairly devastating conditions for pediatric patients. So that program is ongoing.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

All right. Next question?

Operator

Operator

Thank you. Our next question comes from the line of Geoff Meacham with Barclays. Your line is open.

Geoffrey Meacham - Barclays Capital, Inc.

Analyst · Barclays. Your line is open.

Good morning, guys. Thanks for the question. A couple on Praluent. I know you guys don't want to give too much detail on launch strategies, but is relaxing payment terms as you do with EYLEA initially part of the plan? If you don't want to answer that, when you think about the economics, the payback economics to Sanofi for Praluent, are those flexible depending on the launch trajectory? In other words, can you tweak those in a material way depending on the trajectory? Thanks. George D. Yancopoulos, M.D., Ph.D. - Founding Scientist; President, Regeneron Laboratories and Chief Scientific Officer: The payback economics are based upon a percentage of profit, so it's already – it's all embedded in there and it's only based on the percentage. When the product turn profitable we pay a percentage, 10% of our profits back for repayment.

Robert J. Terifay - Senior Vice President, Commercial

Management

In terms of the payment terms and remember EYLEA is a buy-and-build product under very different circumstances from Praluent, so we don't have the same terms.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Next question, operator?

Geoffrey Meacham - Barclays Capital, Inc.

Analyst · Barclays. Your line is open.

Great. Thanks.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Thanks, Geoff.

Operator

Operator

Thank you. Our next question comes from the line of Biren Amin with Jefferies. Your line is open.

Biren Amin - Jefferies LLC

Analyst · Jefferies. Your line is open.

Yeah, thanks for taking my questions. Maybe just on EYLEA. Could you review the physician assessments program that you're providing with the DME launch, because I believe you had a pretty robust program at the time of the wet AMD launch? And second question is on PD-1 Phase 1 trial. What tumor types are being enrolled in? What's the rationale for combination with cyclophosphamide? Thanks.

Robert J. Terifay - Senior Vice President, Commercial

Management

So, our patient assistance program is consistent with all of our EYLEA indications. We have an income cutoff of $100,000 per patient in terms of income. And if they fall within that, they get access to the patient assistance.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

George, the question was on rationale for cyclophosphamide in PD-1. George D. Yancopoulos, M.D., Ph.D. - Founding Scientist; President, Regeneron Laboratories and Chief Scientific Officer: Yeah, the notion is that cyclophosphamide might be, in a certain way, not blocking T-cell effectiveness and response while activating a certain type of immune activation pathway, so that it might work well to go in combination with PD-1. In terms of in our first studies, we're going after a board group of diverse patients in terms of cancers.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Operator, we have time for one last question.

Operator

Operator

Thank you. Our final question comes from the line of Matt Roden with UBS. Your line is open.

Matthew M. Roden - UBS Securities LLC

Analyst

Great. Thanks very much for taking the question and congrats on really nice progress this quarter. I just want to go back to EYLEA. And, Bob, it seems like everything that you're describing here in terms of the gains that you've made commercially with EYLEA in really all settings should be practically sustainable, right? And yet this quarter, we've seen a 21% Q-on-Q growth that's a lot higher than we've seen in the recent three quarters or so, really the most we've seen in three years. So I guess what I'm getting at is, when you look at the guidance, it seems to imply reversion to single-digit growth for the remaining 3Q and 4Q this year. And I'm just trying to understand why shouldn't the gains that you've made be sort of sustainable? And it occurs to me that the guidance might just be conservative, but I'm just trying to understand if there are any other factors we need to consider that should drive a reversion in the growth. Thanks very much. Leonard S. Schleifer, M.D., Ph.D. - Founder, President, Chief Executive Officer & Director: Bob may want to comment beyond the usual factors, which are includes seasonality, there's effects on the pent up demand that maybe were satisfied after Protocol T came out. Bob, anything else?

Robert E. Landry - Chief Financial Officer

Management

Well, I think our guidance, we feel very confident in. But yeah, we do model based upon what happens in previous years and we do see in the third and fourth quarter that there is with vacations and holidays and the risk of snow, that sometimes there is some seasonality.

Michael Aberman, M.D. - Senior Vice President, Strategy and Investor Relations

Management

Great. Thank you everybody for participating in this call. As I mentioned earlier, the IR team as well as our CFO, Bob Landry, is going to be available if there's follow-up questions. We'll be in our office. Please shoot us an email or give us a call and we'll try to get back to you. Thank you very much. Operator, that concludes the call.

Operator

Operator

Ladies and gentlemen, thank you for participating in today's conference. This concludes today's program. You may all disconnect. Everyone, have a great day.