Welcome to the Regeneron Pharmaceuticals First Quarter 2020 Earnings Conference Call. My name is Crystal and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session. Please note that this conference is being recorded.I would now like to turn the conference over to Justin Holko, Vice President of Investor Relations. You may begin.

Thank you, Crystal. Good morning, good afternoon and good evening to everyone listening around the world. Thank you for your interest in Regeneron Pharmaceuticals and welcome to the first quarter 2020 conference call. An archive of this webcast will be available on our website.Joining me on the call today are Dr. Leonard Schleifer, Founder, President and Chief Executive Officer; Dr. George Yancopoulos, Co-Founder, President and Chief Scientific Officer; Marion McCourt, Senior Vice President and Head of Commercial; and Bob Landry, Executive Vice President and 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 today's 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, financial forecast and guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement issues, intellectual property, pending litigation and other proceedings 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 that statement. 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, including its Form 10-Q for the quarterly period ended March 31, 2020, which has been filed with the SEC today.Regeneron does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. In addition, please note that GAAP and non-GAAP measures will be discussed in today's call. Information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP is available in our financial results press release, which can be accessed on our website. Additional information about those measures is also available on the investor and media section of our website. Once our call concludes, Bob Landry and 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. Len?

Thank you, Justin. And thank you to everyone for joining the call. I hope all of you are staying safe and well during this difficult time. We're living in a new reality, the reality of COVID-19. I am incredibly proud of the leadership role Regeneron is taking in the fight against COVID-19.Clearly, this pandemic is unprecedented in our lifetime, for our company, our country and the world and the world economies. Regeneron has spent decades and billions of dollars developing proprietary technologies that have created medical breakthroughs, such as Dupixent and our novel antibody cocktail for Ebola, which is now under FDA review.These same technologies are now well purposed for finding a treatment against the SARS-CoV-2 virus. We are making rapid progress and scaling up supply of our novel antibody cocktail, which we expect to be in clinical trials this June. We are optimistic about this approach, which George will describe in greater detail.Also we are working swiftly with our collaborator Sanofi to find a definitive answer on whether there is a role for Kevzara in helping to alleviate the devastating inflammation that affects patients who are critically afflicted with this virus. We are grateful for the tremendous partnership across industries, governments and agencies such as the FDA and BARDA, as we unite in the common cause to eradicate this disease.Beyond our therapeutic efforts we continue to respond to other urgent COVID-related needs. We recently produced and donated viral transport media to New York State for use in 500,000 test kits and have provided financial support to non-profits at the heart of the pandemic response, in New York and beyond.Furthermore, we are sensitive to the rapidly evolving marketplace and working with customers to ensure that patients are able to receive the treatments they need to preserve vision, as well as…

Thank you, Len. And since the devastating COVID-19 crisis is foremost on everyone's mind I will first discuss our efforts in this area. As you all know, our state of the art and proprietary VelociSuite technologies, which we have built over the last few decades. It can be very powerful for responding to new targets and pathogens, as we recently proved by rapidly creating an antiviral antibody cocktail as an effective treatment for Ebola.Recall, the FDA recently granted priority review to this treatment for Ebola with the target action date of October 25, 2020 based on the results of the Phase 3 PALM clinical trial conducted in the Congo, which was stopped early because of our Regeneron EB3 antibody cocktail proving superior and preventing death compared to the previous standard of care the so-called ZMapp antibody as well as to Remdesivir.In terms of COVID-19, while society is awaiting an effective vaccine that could still be a year or two away, we are employing a two-pronged approach that could serve as a useful bridge and/or as an alternative to a vaccine. First and most importantly, we are developing a novel antiviral antibody cocktail just as we did for Ebola. We have already announced that we have utilized our VelociSuite technologies to rapidly generate and select thousands of potent antiviral fully human antibodies from both our genetically humanized Velocimmune mice as well as from convalescencing human volunteers, creating what we believe is the largest and deepest collection of potent antiviral antibodies to choose from.We have selected two distinct antibody cocktails from this collection, our initial cocktail as well as the backup. And we have already begun large-scale manufacturing and anticipate initiating clinical trials with elite cocktail in June. With Ebola, we set the record of nine months from initiating the project to…

Thank you, George. Our business performance in the first quarter reflects continued healthy demand driven growth of our core brands, EYLEA, Libtayo and DUPIXENT. While COVID-19 began to impact our business in the latter half of March, our first quarter results were strong.I'm going to begin with EYLEA performance. EYLEA had an impressive start to the quarter with continued share gains. Global net sales grew 6% year-over-year to more than $1.85 billion and U.S. net sales grew 9% to $1.17 billion versus the prior year. COVID-19 began to negatively impact EYLEA sales with a greater impact from the pandemic on patients with diabetic eye disease than on patients with wet AMD. There was a sharp decline in overall demand in the last two weeks of March and first two weeks of April, followed by a sharp rebound in the most recent two weeks.Overall, in the month of April, demand was approximately 15% lower than the same time last year. We're encouraged by the recent rebound, although it is difficult to predict future COVID-19 impact. Despite these circumstances, we've been extremely impressed with retina specialists' efforts to ensure continuity of patient care. Physicians use EYLEA to preserve the patient's vision because of its breadth of indications, dosing flexibility, convenience and safety. EYLEA dosing can be extended up to 12 weeks in appropriate patients and the recently launched Pre-filled Syringe offers additional efficiency of care.Additionally, we've evolved our efforts to support the retinal community through virtual engagement, as well as providing patient ads to self-monitor vision. We have plans in place to support customers and meeting anticipated higher demand for EYLEA once social distancing measures are relaxed. In summary we're confident that EYLEA can navigate through and grow beyond COVID-19.Turning to Libtayo. First quarter global net sales were $75 million. In the…

Thanks Marion. For the first quarter of 2020, Regeneron delivered solid results on both the top and bottom line, despite COVID-19 beginning to impact our business operations in the latter half of March.Today, I will first briefly discuss the first quarter results and then conclude with our 2020 guidance, effective January 1, 2020 we implemented changes to our accounting presentation related to certain reimbursements and other payments from collaborators. As such our first quarter 2020 and comparable 2019 financial statements have been prepared under the new accounting presentation.We made these changes to better reflect the nature of the company's revenues earned and costs incurred pursuant to arrangements with collaborators. Importantly, these changes provide a simplified presentation of our financial results. They do not impact income from operations, income taxes, net income or net income per share. For more information regarding these changes please refer to the slide presentation in FAQ on the Regeneron Investor Relations website.Turning now to the results. First quarter 2020 revenues grew 33% year-over-year to $1.83 billion driven by continued growth of both EYLEA and Libtayo, as well as higher Sanofi collaboration revenues as a result of strong performance from our DUPIXENT franchise. Non-GAAP diluted net income per share grew 48% year-over-year to $6.60 on non-GAAP net income of $771 million.Since Marion discussed our U.S. EYLEA results, I will start with our Bayer and Sanofi collaborations. Starting with the Bayer collaboration. Ex U.S. EYLEA net product sales which are reported to us by Bayer were $682 million representing growth of 2% on a reported basis compared to the prior year.Total Bayer collaboration revenue was $281 million, an increase of 7%. We recorded $254 million for our share of net profits from EYLEA sales outside the U.S.. Total Sanofi collaboration revenue which under the new accounting presentation consists…

Thank you Bob. Crystal that concludes our prepared remarks, we'd now like to open the call for Q&A. Just a word that, we have more than 20 callers in the queue, so to ensure that we are able to address as many as possible, we will answer one question from each caller before moving to the next. Please go ahead, Crystal.

[Operator Instructions] Your first question comes from the line of Evan Seigerman from Credit Suisse.

Hi, all. Thank you for taking my question, and congrats on the progress this quarter. Thank you also for your efforts in combating the pandemic. So with data from both the frontline lung trial last week and basal cell carcinoma today, can you expand as to what's next for your oncology franchise? How do you plan on competing with the standard of care in the front line lung setting and more broadly across tumor types amenable to IO therapy?

So, George?

And I guess that most importantly, as we noted, the lung field is dominated by leading antibody that has produced the most impressive data. We are very excited that our monotherapy trial has delivered data that looks very impressive in terms of the overall survival endpoint. And we have an ongoing combination trial with chemotherapy as well that we're excited about having it read out over the coming year or so.And so I think that this is going to position us well in such a large opportunity, where physicians and patients are looking for alternatives to have an agent that has such profound activity as a monotherapy. But in addition, we have all these combination programs that I was referring to. We have we believe one of the most exciting homegrown pipelines of additional agents that we could combine to not only enhance the activity in these settings where the PD-1 monotherapies are already active, but also to extend to new settings and new indications, such as I mentioned, whether it be prostate cancer or ovarian cancer or others where right now the activity is not what we would want.So I think that we've put ourselves into a pretty exciting position, where we have some of the most exciting agents with identified profound clinical activity as monotherapies, but we now have the opportunity to mix and match these as is appropriate to enhance and extend the activity. So we're very excited about the oncology situation.

Yes. And just to add on the commercial side, it's Len and maybe Marion can chime in. You know obviously we collaborate with Sanofi where we take the lead in the United States. They take the lead outside the United States, but we work together with them. And this disease is dominated by lung cancer, maybe Marion a little bit about the numbers the incidence prevalence what kind of marketplace we're going into?

Yes. So lung cancer is a disease with a very large incident population of more than 200,000 newly diagnosed patients each year. So, we do think that there's tremendous opportunity and know that oncologists prefer having a choice in determining treatment for their patients.So we're excited about the data and we'll work carefully with Sanofi on launch preparedness, and certainly have built a commercial team that has extensive experience in competitive launches. We look forward to this opportunity if in fact we have an approval for lung and for basal cell.

Thanks, Evan. Next question?

Your next question comes from the line of Geoffrey Porges with SVB Leerink.

Thank you very much and congratulations on both the surprisingly strong quarter, but also all the progress on the pipeline. George, we haven't had a lot of access to talk to you about the COVID programs. But could you just expand a little bit on the backup program what its nature is? And the related question of what do you view as the risk of both ADE and also of the antibodies in some way contributing adversely to the inflammatory syndrome in the tail end of this disease?

Yes. Those are great questions. So what we were able to generate, because we have these very robust platforms both the ability to get fully human antibodies from our genetically humanized mouse model, as well as from recovering humans. We generated a collection of thousands and thousands of antibodies.Getting many antibodies that really were at the top end historically at the best level of binders and blockers and antiviral neutralizers that you've ever seen based on the literature and the history. And so what we did was, we simply selected several cocktails of the best antibodies where we put them together, and we created our initial cocktail and a backup cocktail just in case for some reason something goes wrong with the initial cocktail. So they're actually quite similar. It's just a different collection of antibodies for the backup as well as for the primary.Now we think that based on the history of treating infectious disease and viral diseases with highly potent neutralizing antibodies, the risks of things such as antibody-dependent enhancement and so forth are actually quite limited. You actually see these, for example, in certain classes of viruses, the Flaviviruses, the dengue type viruses and so forth in particular, but that's because of the biology of the viruses there.With most other viruses when you have highly potent neutralizing antibodies these risks are mitigated. We do have -- in addition to our backup collection of antibodies, we do also have our antibody cocktails made with what we call Uber-stealth constant [ph] regions, which would completely mitigate against that possibility. But for the current approaches that we're taking, we're going to be going forward with the fully armed antibodies, because we think the risks of ADE with very potent neutralizing antibodies is actually quite low.So I think that the history of antiviral antibodies, our experience the way they work our own antibodies and other programs most notably in Ebola, we think that there's a very significant chance that these specifically designed, very potent neutralizing antibodies will have a significant impact on the disease. We think that there's a great chance that they can be very powerful prophylactic and preventive agents. But we also think that they can treat patients who are already symptomatic with disease.And we don't think that right now there's any evidence that suggests that the antibody response is what's contributing to the inflammatory responses in the lung. And as, of course, as has already been seen and described in the disease, the majority of patients do recover and their recovery is coincident with their producing viral responses.So altogether I think there's a lot of reason to have a lot of hope that this approach really has a chance to make a difference as we said both in prophylactic treatment, but also in treating symptomatic patients.

Thanks, Geoff.

Thanks for taking my question.

Your next question comes from the line of Cory Kasimov from JPMorgan.

Hey, good morning, Leonard. Thanks for taking the questions. Just to follow-up on Geoff's question on the COVID-19 front. George, how you're thinking about the clinical trial designs for your antibody cocktail both from a prophylactic standpoint, as well as a therapeutic? And on the latter, do you plan to either go head-to-head or on top of remdesivir if you run initial studies in a hospital setting? Thank you.

Well, we're planning on doing three sets of trials in the prophylactic or prevention setting in people who are at high-risk in early treatment that is patients who are not at the level that they would be normally hospitalized. But patients who are identified they're symptomatic. If they do go to an ER, they are sent home, but they don't need oxygen support.However, significant number of them do develop more serious disease and then have to return to the hospital. So the idea would be to stop the disease in those individuals and stop the progression and the need from them going back to the hospital. And then we're also going to go to the hospitalized setting very similar to what we're doing with KEVZARA and where the Remdesivir data has read out.So certainly, the only setting where it would be on top of an existing standard-of-care potentially would be in the late treatment setting, we would certainly be going on top of standard- f care there whether it be Remdesivir or maybe we'll see whether there's data from other agents by that time as well.In the prophylactic setting, there is no need and there's also no other standard of care and in the same thing in the early treatment. And I would remind you once again that based as I said on our experience in other programs and most notably a good example is the Ebola program, the earlier that one treats, the better one does.I remind you early in the disease for Ebola, which is obviously a much more lethal disease with much higher levels of severe disease and death we were able to save more than 90% of the patients when we went with early treatment. So I think that there's a lot of reason to think that in this setting these sorts of antibodies both in the prophylactic setting and in the early treatment setting can have really profound benefits on their own.

Thank you for the question, Cory. Next.

Your next question comes from the line of Tim Anderson from Wolfe Research.

Thank you very much. On your antibody cocktail. I'm wondering, if you think Gilead's actions with Remdesivir essentially set the bar for other companies in terms of what they may be expected to do specifically in terms of giving away some portion of initial therapy free at the outset? Thank you.

Len, you want to take that? Len?

Yes, hi. Sorry. It's Len. We've spent all of our energy right now focused on getting the technical success that George described and that we hope to see. And in parallel, we have been working to clear manufacturing capacity in our New York plant so that we can make it at large scale. We hope to be able to have a couple hundred thousand doses by the end of the summer and then continue to manufacture from there. In terms of pricing, donations, and fair values and all that sort of stuff that's just got to come down the road a little bit.

Thank you.

Next question.

Your next question comes from the line of Ronny Gal from Bernstein.

Good morning, and thank you for taking my questions. I want to go back to Libtayo non-small cell lung cancer. I hear you about physicians wanting to have a choice in monotherapy between KEYTRUDA and a second product. The question is why should they choose Libtayo, the KEYTRUDA? I think you've got a product here, which is just to make the point a few years is the standard of care used extensively.Can you just share with us in your data, is there other elements of the data you're seeing from the trial would suggest that there is any group of patients where physicians should prefer Libtayo over KEYTRUDA what is your marketing argument here? And before I stopped there, I just want to thank you for all the efforts you're making against COVID-19 just adding to my peers here.

Thanks, Ronny. It's Len. It's way too early for us to be making any comparative statements. We literally, just recently got the, good news from the data monitoring committee that we met with highly statistical significance, as George described survival.We've got a lot more data to go. We've got a lot more studies to look at. It's not just one study. It's not just the cross-study comparison. There's going to be a lot more that goes into this. And we'll just have to see how this evolves.But the history of the industry typically is that, if there's just a couple of competitors, you have to remember that the size of this market. Last year it was about $22 billion of which about 70% or 75% was lung cancer. And that was largely driven by Keytruda sales. So there's a pretty big opportunity to have some important alternatives. And you just have to wait, I'm sorry Ronny to see how this all evolves when we roll this out.

Sure. Thanks, Ronny. Next question.

Your next question comes from the line of Chris Raymond from Piper Sandler.

Yeah. Thanks. Just back to the antibody cocktail, I guess. So George, a lot of folks, I guess close to the FDA and maybe some with a fairly loud voice on these COVID matters, just keep talking about at least one of the therapies one of the antibody therapies, that's in development being available, as early as this fall.So I guess, maybe just talk about how is that possible, from a clinical development standpoint? And especially in light of the program you just described, George with the three different settings. Obviously, when there's something that's even under an emergency use authorization available, how do you conduct that? Thanks.

Well, yeah. I think that, these are all great questions. We're in unprecedented times. I think that, the urgency and the collaborative spirit between regulators, between medical institutions, between companies, it has never been seen before. And also our commitment to this is something we've sort of done it before. But now we're trying to take it to the next level.So we are planning, as we said in June to simultaneously initiate trials, in the three settings that we're actually talking about. We are thinking of ways to synergize between the three classes of trials that we're talking about. And we are hoping -- I mean this is going to depend on a lot of factors. And there's obviously a lot of risk and concerns, whether this can be done, since it hasn't ever been done before.But we are really hoping that, we'll be able to not only initiate these studies, but able within a month or two to perhaps if these agents are working as well as we might hope they would work, as well as for example some of the precedents set by Ebola suggest that they might work, that we might within that month or two be getting data.If we were to get data, within those sort of timeframes as Len describes we have already committed at risk to manufacturing the drug supply this could be providing by the end of the summer, hundreds and hundreds of thousands of doses, of these antibodies. So, you're right. It's never been done before.On the other hand, I don't think we ever had quite a pandemic like this before. And I think that, some companies like ours have really put themselves in a position with the technologies, the commitments, the investments that we've made to put ourselves in a position, to maybe help out and make a difference here.And regulators like the FDA, BARDA everybody is coming together to try to help us in this situation to meet the urgency and meet the dire need that we might have here. And so the hope is yes, it might be possible by the end of the summer or the fall that, our antibody treatment could be available. A lot of risks, a lot of concerns, but we are working as hard as we can with so many collaborators to try to turn that into a reality.

So we still have several callers – sorry, we have several callers still in the queue. So we'll extend for a few more minutes, if we can.

Let me just put a finer point on that. But just in a second. I completely agree with what George said. And I think if you listen carefully to what he was saying is that, because we're doing three different types of studies, the timing on the different studies might be quite different.If you're dealing with people, who already have the disease, then you're not waiting for that long period to occur, when you're trying to prevent the disease. And people who already have the disease, the cause of the disease sort of declares itself, over a several week to month period.And so you could imagine, depending upon what's going on. How many people are actually showing up at the hospital? How many people are hospitalized, in the ICU that that part could go a lot faster? But of course, you can imagine that George and the team have got a lot of great strategies, for the early part, to try and find people at high enough risk, which is the hard part in a preventative setting. Sorry next question.

Your next question comes from the line of Terence Flynn from Goldman Sachs.

Hi. Thanks as well from me for your efforts on the COVID front. Maybe another one for George on, bispecifics, I was just wondering if you've already generated data from your PSMA bispecific antibody as monotherapy. And if that's what led to your decision to initiate a combo trial with Libtayo?And then the second part of the question relates to your comment George about, seeing continuing promising activity. I was wondering if that was only on the BCMA bispecific, or has that also covered the MUC16 bispecific? Thank you.

Yes, great questions. I guess, first of all, basically, we think that, the bispecific costims. We've described these in the literature. We have a lot of data on them. On their own they are designed to essentially have very little or no activity. And only when combined with either a CD3 bispecific or with a PD-1 agent do they then essentially synergize and amplify the benefit or activate the benefit of the other agent.And we've done a lot of work on that. Quite a bit of published work has already been shown on that. And the early data in the clinic are supporting that in that the monotherapy costim was not intended and did not show single-agent activity. We are now in the combination program, where we are hoping to now activate activity by adding the costim to the PD-1.That's how they were designed, that's what we're hoping to see and that is what we are hoping to be able to generate data that we will be giving you information on in the future. In terms of the promising activity, I think that yes, we have seen robust activity with the BCMA. We have not really reported anything on the MUC16. I can say that we are seeing evidence of activity and we'll give you more details on that in future times.

Thank you, Terence. Next question?

One second, Terence if I may. We appreciate all the comments from the analyst community thanking us for what we're doing. We just want to say. we find your notes very useful and very helpful. The coverage of this pandemic, the useful information that all of you provide and what's going on and what the rates are of this and that and what to be expected we really appreciate that as well.

Next question?

Your next question comes from the line of Josh Schimmer from Evercore ISI.

Great. Thanks for taking the question. Another one COVID-19. How do you determine the optimal dose for passive immunization, especially if you have to adjust for different levels of exposure? How long do you think a single dose will confer protection? And then what are realistic goal in terms of the number of people you can support beyond August with prophylactic use considering potential supply constraints? Thank you.

Okay. Well, basically we have accumulated over many years now, a lot of understanding about the doses that one needs to block viral infection particularly of respiratory and other diseases. So we actually know both in animal models and in humans the blood levels to block respiratory infection. And so we are targeting to be significantly above those blood levels for a minimum of at least a month for the prophylactic setting.So there's no guarantees. Once again these are all predictions based on experience in other programs with other viruses but including for example, the MERS coronavirus. And so we believe we have a good target blood level that we need to meet and achieve and stay above on for at least a month for the prophylaxis setting.And so the prophylaxis dosing is intended to last for at least a month. For example in our RSV program – for one of our programs there, we were able to have protection for several months. So minimum of a month is our current target based on maintaining blood levels that we believe you have to maintain above for preventing infection by respiratory viruses. What was the rest of the question?

In terms of supply – yes I'll take that George. Thanks. In terms of supply, we've going as fast as we can. We have an amazing capability in technology that allows us to get high producing cell lines very rapidly. We know how to make antibodies. We are one of the companies that can do this from end-to-end seamlessly. And so I'm optimistic that we can expand from the initial numbers we talked about and continue to manufacture.We have had inquiries from multiple other companies about perhaps wanting to manufacture a cocktail when we have good data and we suspect maybe the government may want that to happen as well, where we can expand through collaborative efforts and sort of take the unprecedented step of letting some of our technology outside the company for this purpose as well, because that's what probably will need to be done.

Thanks, John. Next question.

Your next question comes from the line of Yaron Werber from Cowen.

Hey, good morning. Thanks for asking quick question. I'm going to shift a little bit George and maybe fasinumab, just so we don't lose track of that program. It sounds like that data is coming up pretty soon the Phase III osteoarthritis data. Any thoughts? And any thoughts on Pfizer-filed fasinumab for approval? So this is totally overlooked but I want to know what's kind of coming down as you can share? Thank you.

Yes. Our viewpoint with fasinumab is that for a long time now as obviously, I think most people appreciate is that in many ways, this is a very risky program in that. There are – there is a now well-defined adverse event that we are trying to tighter around with the dose. And I think the major question for this program is whether we have been able to find a dose that threads the needle between the safety concern and between providing sufficient benefit to patients.I think if you see other competitors' data here, it's been a little difficult for others to thread the needle. So this is what we're going to see, especially when we see the data that comes out from our ongoing program that we'll be getting by the middle of this year, how well we've done to actually find a magic spot on the dose response curve, where we have sufficient safety but sufficient benefit and how that might compare to what others have achieved.So we are as anxious and excited as you are to see whether we may have threaded this needle in a way that really provides an important alternative for patients as we know there is a crying, literally a crying need here for new pain medications and particularly for the osteoarthritis population and we are hoping that we may have threaded that needle.

Thanks, Yaron. We're going to try to cut the call about quarter to the hour that leaves us with time for one to two more questions. Next question, Crystal.

Your next question comes from the line of Carter Gould from Barclays.

Great. Good morning. Thanks for taking the questions. I pass on my congrats on the Libtayo data sets and thank you for all the COVID efforts. Maybe just focusing back on Libtayo for a second. It sounds like most of the commentary is, sort of, reaffirmation of the development strategy here and, sort of, validation of the efforts to-date. I guess -- but with this data in hand particularly the lung data does this, sort of, either accelerate your focus on broad -- further broadening out of the novel-novel combinations or potentially a shift to bringing in outside agents maybe a shift in, sort of, that partnership strategy? Thank you.

Right. I think that this is really a landmark for the field, but also for us. Keytruda has stood really unchallenged now particularly in lung cancer, which is driving most of the sales for this entire field. Because others haven't actually been able to show that they've had a Keytruda-like agent. I think that I understand the concerns about people talking about how are you going to compete?But having something that's already showing this profound clinical activity that we're now seeing as a monotherapy with also, having also identified this is another thing that people have to appreciate new first-in-class indications that have been missed by the rest of the field. First with cutaneous squamous cell carcinoma now with basal cell, I think are establishing Libtayo as a legitimate monotherapy alternative.And as Len said, when you have opportunities such as $8 billion opportunities in first line history shows that bona fide competitors with profound clinical activity they are going to get significant shares. But I think, it's exactly as you said, we believe we are now in a position where we can compete in these monotherapy situations, but it only amplifies our excitement and our commitment to the combination approach. And of course, as you say we are working hard to find the right outside collaborators. And I think we've already announced quite a few of them that we're very excited about, that we're already starting combination studies on and so forth, but we are just as excited about our internal homegrown pipeline.We have been preparing, a series of combination assets just for this moment now where we will have this potent powerful PD-1 antibody of our own. Our entire strategy depended on it and now that the molecule has come through and proved that it really is a bona…

Crystal, we have time for two, three quick questions.

You can be sure we're getting together with our collaborator Sanofi on this and going to look carefully about how to move this forward and how to compete well with the data, we have and other data we want to get.

Crystal, this is time for two more quick ones.

Thank you. Your next question comes from the line of Geoff Meacham from Bank of America.

Hey, guys. Thanks for the question and for squeezing me in. I want to ask another one on COVID cocktail. Just to follow-up George on some of your earlier comments about rolling out efficacy studies next month. I'm assuming that or can I infer that you're bypassing traditional Phase I safety studies and healthies and then when you think about manufacturing scale up what's the opportunity to outsource or to partner should you have much higher demand and success obviously in the pivotal study? Thank you very much.

Yes. I think that we have been already in active conversation with regulators exactly on the points that you talk about. And I think these are unprecedented times and I think also when you have the history with these types of agents, it does allow you and it does allow the comfort of the regulators that one could be moving forward very quickly. And so as you might imagine along the lines of the things that you proposed these are exactly the sorts of things that we're talking about with regulators. And we're trying to employ into our designs.In terms of your second part of your question, I think, Len already started talking about this point, which is we have made a huge commitment to enable our entire upstate New York manufacturing facility to be devoted to this effort, which on its own could supply hundreds of thousands if not over the course of time maybe even on the order of a million or so doses per month. However, even that might not be sufficient depending on the demand, depending on whether there's a second wave, depending on what happens with vaccines and so forth. So we are actively talking about collaborations with others who are very interested in bringing their resources to the table here too.As we said, there's enormous collaborative spirit that I think we haven't seen before between companies to come together, to help each other out, to really make a difference here in this pandemic. And so that opportunity is really out there. We're actively talking with people. And of course it all depends on whether these antibodies deliver. But if they deliver and depending on the state of the pandemic if there's more need I am sure that there will be ways that either we on our own or with major collaborations will be able to supply more to more patients.

Okay. Crystal, last question. Unfortunately, we have a lot of people still in the queue but this will be our last question

And your question comes from the line of Yatin Suneja with Guggenheim.

Good morning, everyone. And I also appreciate all the effort on the COVID front. I also would like to complement Bob for simplifying the accounting, really appreciating a much cleaner guidance that you provided today. So the question is on the EYLEA front. I think Marion, pre-COVID you were anticipating total market supply for prefilled syringe by March. Could you comment where you are in terms of the supply of PFS? And any impact you saw of PFS an idea performance in 1Q? And also, I'm not sure if there was any inventory dynamic that you commented on earlier today. Thanks.

Okay. So sure. Let me take those. I'll start with your last. So in terms of inventory, we have stayed at normal levels. So we're not seeing anything unusual in terms of inventory. Your next question on prefilled syringe, we do think prefilled syringe is a very attractive alternative in the marketplace. And the use of the prefilled syringe has gone up to about 75% of total use of EYLEA. We have, as you know, introduced prefilled syringe in a staggered way starting towards the end of last year. But it's been very well received and we do intend to have not only prefilled syringe, which of course is growing in popularity, but we'll also maintain vials in the marketplace.And then I believe the other item that you were commenting on was in terms of the COVID impact, and as I shared certainly in the first quarter we had very robust performance with EYLEA, and saw our sales grow in the U.S. marketplace 9% in net sales over the prior year. We did see, as I mentioned, a decline in overall demand in the last two weeks of March and that continued into the first two weeks of April, then we saw a sharp rebound in the most -- meaning a positive trend in the last two weeks. So that when you put all that together and all those factors together, demand in the month of April was approximately 15% lower than in the same period last year.But I go on to say, it's hard to predict what will happen with the COVID impact going forward. But we remain very confident in EYLEA's profile, our commitment to the retinal specialist community, and the -- obviously, the very attractive profile we have, both clinically and from a safety standpoint with EYLEA. We're supporting our offices through appropriate promotion and support so that when patients flow -- returns in a more robust fashion, we certainly look forward to the opportunity to help those patients with EYLEA and support our prescribers.

Thank you everyone. That's going to conclude our call. We appreciate everybody hanging on a little longer today, given all the things that we had to speak to and all the great questions that came in. Bob Landry and the IR team will be available following the call to answer further questions. Thank you.

Stay safe.

Ladies and gentlemen, this concludes today's conference. Thank you for your participation, and have a wonderful day. You may all disconnect.