Good morning. My name is Grace Lakra and I'll be your conference operator today. At this time, I would like to welcome everyone to the Merck & Co. Q3 Sales and Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. [Operator Instructions] Thank you. I would like to turn the call over to Peter Dannenbaum, Vice President of Investor Relations. Sir?

Thank you, Grace. Good morning. Welcome to Merck's third quarter 2021 conference call. Speaking on today's call, we will be Rob Davis, Chief Executive Officer. Frank labor and president of human health. Caroline Litchfield and Chief Financial Officer. And Dr. Dean Li, President of Merck Research Labs. Before we get started, I'd like to point out a few items. You will see that we have items in our GAAP results such as acquisition-related charges, restructuring costs, and certain other items. You should note that we have excluded these from our non-GAAP results and provide a reconciliation in our press release. I would like to remind you that some of the statements that we make today may be considered forward-looking statements within the meaning of the Safe Harbor provision of the U.S. Securities Litigation Reform Act of 1995. Such statements are made based on the current beliefs of Merck's management and are subject to significant risks and uncertainties. If our underlying assumptions prove inaccurate or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Our SEC filings, including Item 1A in the 2020, 10K identify certain risk factors and cautionary statements that could cause the Company's actual results to differ materially from those projected in any of our forward-looking statements made this morning, Merck undertakes no obligation to publicly update any forward-looking statements. During today's call, a slide presentation will accompany our speakers prepared remarks. The presentation today's earnings release, as well as our SEC filings are all posted to the Investor Relations section of Merck's website. With that, I'd like to turn the call over to Rob.

Thanks, Peter. Good morning, everyone, and thank you for joining today's call. I'm very pleased to report significant progress across our key growth and strategic priorities in Merck's first full quarter as a more agile and focused science-driven Company. We have strong momentum in our business. We've achieved notable clinical milestones, acted on a significant business development opportunity consistent with our strategy, and executed commercially to drive strong performance this quarter. We're also working with diligence and urgency, which is reflected in the speed with which we were able to bring forward our investigational COVID-19 antiviral Molnupiravir and to rapidly file for emergency use authorization with the FDA. It's an exciting time at Merck, and we are determined to build on our recent successes as we pursue our mission to deliver innovations that save and improve lives and as we seek to create long-term value for both our patients and our shareholders. Dean will speak to the significant pipeline advancements we are making in a minute. But I first want to congratulate him and our research colleagues, as well as our partners at Ridgeback Biotherapeutics on the meaningful clinical results we recently reported regarding the development of Molnupiravir. From the onset of the pandemic, Merck has sought out opportunities to apply its scientific expertise in the global fight against COVID-19, and we are very pleased to now be in a position to make a meaningful difference. As you are aware, at a planned interim analysis of our Phase 3 trial in at-risk, non-hospitalized adult patients with mild to moderate COVID-19, Molnupiravir reduced the risk of hospitalization or death by approximately 50% compared with placebo. Based on these results, and in consultation with the FDA, we stopped our trial early. We're now working with the FDA as the agency reviews our…

Thanks, Rob. Good morning. As Rob highlighted, the momentum in our Human Health business continued in the third quarter and we achieved 17% growth excluding the impact of foreign exchange. We have continued to invest with urgency and patient activation programs that improve patient awareness and encourage more normal levels of physician office visits, oncology screenings, and vaccination rates. These actions while aimed at benefiting patient health also meaningfully benefited our largely physician administered portfolio in the quarter. In U.S., we are encouraged that wellness visits and surgical procedures remain at mostly normal levels. In oncology, while screening rates and diagnosis continued to improve, they are unfortunately still below pre - COVID levels. And this is impacting new patient starts. Outside of the U.S., our business performance remains strong despite lingering impacts from the pandemic in certain markets. Now turning to the Third quarter performance of our key brands, my comments will be on an ex-exchange basis. In oncology, KEYTRUDA sales grew 21% to $4.5 billion, reflecting continued robust global demand. In the U.S., KEYTRUDA continues to demonstrate durable momentum across all key tumors, including growth from our recent launches, such as KEYNOTE-522, in neo adjuvant - adjuvant triple-negative breast cancer. KEYTRUDA is continuing to extend its very strong overall IO class leadership, improving new and total patient market share. KEYTRUDA continues to maintain its leadership position in lung cancer, capturing 8 out of 10 eligible new patients despite continued competition. Outside of lung, key tumors contributing to growth include renal cell carcinoma, triple-negative breast, MSI High, esophageal, and head and neck. We're also excited by the recent approval, an upcoming launch of Keynote 826, which is a first anti PD-1 combination approved as a first-line treatment of cervical cancer. Outside of the U.S., KEYTRUDA growth continues to be driven…

Thank you, Frank. Good morning. Our team drove exceptional financial performance in the third quarter. The investments we are making in our strong portfolio and pipeline, as well as in business development, are helping us deliver outstanding near-term performance, while also positioning us to continue to deliver important innovations and long-term value to patients and shareholders. Now turning to our third-quarter results. Tesla Company revenues was $13.2 billion, an increase of 20% or 19%, excluding the positive impact of foreign exchange. The remainder of my comments will be on an ex-exchange basis. As Frank highlighted, as Human Health business achieved improving momentum, growing 17%. Our animal health business also delivered robust growth with sales increasing 14% driven by strong global demand across both companion animal and livestock. Companion animal sales increased 18% driven by global demand in parasiticides, including the BRAVECTO line of product, as well as companion animal vaccine. Livestock sales increased 12%, reflecting strong global demand for ruminant and poultry products, including our animal health intelligence products. I will now walk you through the remainder of our P&L, and my comments will be on a non-GAAP basis. Gross margin was 76.8%, an increase of 0.3 percentage points, reflecting the favorable effect of product mix, partially offset by higher manufacturing costs. Operating expenses increased 11% to $4.7 billion. This was driven by investments in our key growth pillars, particularly in supportive returns care activities and in our early and late-stage pipeline, including Molnupiravir. Other expense increased by approximately $200 million, reflecting higher pension settlement costs. The effective tax rate was 13%, a decrease of 1.4 percentage points driven by discrete items. Taken together, we earned $1.75 per share, an increase of 26%. Turning now to our 2021 non-GAAP guidance. While the pandemic continued to impact many regions around the…

Thank you, Caroline. Good morning, everyone. It is a pleasure to be here to provide a summary of progress made since our last quarter call. I will provide an update on our oral anti-viral candidate Molnupiravir, highlight the proposed Acceleron acquisition, spotlight some recent progress with [Indiscernible] and finish with this synopsis of notable regulatory milestones and clinical updates from across the pipe block. The need for additional treatment options remains key and combating the COVID-19 pandemic. Interim analysis from MOVe-OUT, our Phase 3 study evaluating Molnupiravir and at-risk, non-hospitalized patients with mild-to-moderate COVID-19 showed an approximately 50% reduction in the risk of hospitalization or death compared to placebo. [Indiscernible] grew day 29, no deaths were reported and patients who received Molnupiravir compared to 8 deaths on placebo. This is the first oral antiviral for respiratory virus to demonstrate benefit based on robust clinical outcome and the first to show a meaningful five-day window for therapeutic intervention after symptom onset. Based on these positive results and as the recommendation of the independent data monitoring committee and in consultation with the FDA, recruitment into the study was stopped early. In light of these findings and given the urgency to address the pandemic, our teams work tirelessly to submit a robust package to the FDA for EUA within 10 days of receiving data. We look forward to discussing the EUA submission at an upcoming meeting of the Antimicrobial Drugs Advisory Committees scheduled for November 30th and [Indiscernible] Korlym, we continue to engage with the FDA to support its review. Applications have also been submitted to multiple regulatory agencies around the world. I do wish to take a moment to thank the investigators, patients, and their families for their participation in the move-out study. I'm also grateful to our collaborators at Emory University…

Thank you, Dean. Grace, can you please start the Q&A portion of the call?

Absolutely.

And I'd like to ask the questioners to limit themselves to one question today in order to get to as many different questions as possible.

[Operator Instructions] Your first question comes from the line of Umer Raffat of Evercore ISI. Your line is open, sir.

So, I will just ask on KEYTRUDA and adjuvant lung instead. Have you had an interim and does the stat plan allow for hierarchy where PD - L1 positives is first, and do you expect the benefit to show in patients that did and did not get adjuvant chemo? Thank you very much.

Yes, thank you very much. I appreciate the question. First, I get want to elevate for just a second, we are excited by the emerging data, the role of PD-1 and PD - L1 in the early treatment in adjuvant space. For us, we are gratified that in renal melanoma, breast cancer is just [Indiscernible], there appears to be great effect and these are cancers where there are frequently employed methods for early screening. In relationship to lung specifically, we enjoy a dominant position in lung cancer and in lung cancer, the treatment of latter stage cancer is the predominant stage. As the data and you somewhat alluded to from other companies indicate that in lung cancer, the PD-1, PD - L1 class could be effective in early and adjuvant. In specific and relationship to, then we have a number of early and adjuvant stage lung cancers, and it was a [numerated then applied] (ph). KEYNOTE-091 is also known as the PEARLS trial. KEYNOTE-091 PEARLS is a collaborative study with the European Organization for Research and Treatment of Cancer, and Merck is a collaborator on this trial. This is an event-driven study and we are in active communication with EORTC, and together, we are awaiting data from the [Indiscernible] before the end of the year. And I would hazard a guess that any public announcement from Merck would be announced at the beginning of the New Year.

Great. Thank you. Umer. Next question, please.

Thank you. Next up we have Daina Graybosch from SVB Leerink, your line is open.

Hi, kind of maybe a 2-part question on Molnupiravir and how you're moving forward. The first is there's been some concerns publicly about the genotoxicity and I wonder if you could address the data you have that makes you not concerned about that and then the second concern is maybe with resistance and I wonder how you're thinking about the future and combinations and whether that will be needed to prevent any resistance, maybe from low compliance to Molnupiravir?

Yes. Thank you for that question. This is Dean. I would just emphasize we are very confident in the safety profile of Molnupiravir based on our pre -clinical and clinical data. In relationship to the clinical data, I think most people recognize that in the interim analysis, we had a profound reduction in hospitalization and death -- or death compared to placebo. It was stopped early in -- by the guidance of the DSMB and in consultation with the FDA. In that interim analysis, the inter -- the incidents of any adverse effect was comparable in both Molnupiravir and placebo. And actually, if you look, there were fewer subjects in the Molnupiravir group who discontinue therapy due to an adverse event compared with the placebo group. In relationship to our confidence in the safety profile based on our extensive pre -clinical evaluation I think it's important to recognize that Molnupiravir is a nucleoside analogue that functions by creating [errors] (ph) in the genetic material of RNA viruses. These nucleoside analogue are often used in many other antiviral treatments, including HIV and hepatitis. And we have done a comprehensive non-clinical program to characterize the safety profile of Molnupiravir. It's been written by other people. It's actually been written into scientific journals as well, and we will be presenting all of this data I believe in the AdCom that the FDA will be holding. But, probably the most important pieces of information is that 2 distinct in vivo rodent mutagenicity assays, commonly called the Big Blue and the Big A, which are well-characterized and considered to provide a robust measure of the ability of a drug or chemical to induce mutations in vivo, in these studies we're administering Molnupiravir for longer and higher doses than those employed in the human clinical trial, and the totality of the data from these studies indicate that Molnupiravir is not mutagenic or genotoxic in these in vivo mammalian systems. Now, we have shared these results throughout with the regulatory agencies worldwide, and will continue to provide additional data as this process continues.

Great. Thank you, Daina. Next question, please.

Thank you. Next up, we have Andrew Baum from Citi. Your line is open.

Questions for Frank on Molnupiravir. Just in relation to supply, it strikes me given some of the published improvements in manufacturing and full gram per patient dose. The 20 million looks like a very conservative estimate, given particularly the inclusion of third parties, what could be achieved given the dosing and the API. I'd like a comment, please, on where you think the 2022 real supply could be and second, perhaps you could just comment on the appetite of Merck to use direct-to-consumer advertising or other promotion on Molnupiravir. I understand that promotion and advertising is allowed under an EUA, if you could confirm or deny that would be great. Thank you.

Hey, Andrew, this is Frank. So, a couple of things that I want to highlight is first, we have a line-of-sight and we will produce 10 million of course this year, Andrew, in 2021. And as we have mentioned that we have line of sight and we will at a minimum double that in 2022. So, to your question, no, we're going to do everything we can to increase the supply for this product. In addition, we have voluntary license partners, you have seen, and we also have a number of partners that we're working with to provide global supply. So, rest assured, Andrew, we're going to try to do everything on the supply front. On direct-to-consumer -- I think it's a little bit early for us on that. We have not made a decision around that. We are really focused on doing everything we can to sign up agreements with governments, get the product available globally. And we'll be providing additional information as we go forward, on Molnupiravir, but this is our number 1 priority for the Company and it's something that we're really looking forward to trying to help address the pandemic going forward.

Andrew, this is Rob and I just want to make sure because as I listen to your question, I think Frank hit it but just to emphasize in case others on the phone aren't catching this, the 20 million [Indiscernible] more than doubling what we can do next year. That is Merck's production. We are not including in any of those numbers the 8 voluntary licensed partners in India, nor anyone who the Medicines Patent Pool signs up. So obviously, global production of Molnupiravir will be significantly more next year, we were just speaking to what volumes we will produce within Merck.

Let me just add one thing because I recognize that this question is also somewhat linked to the other question that -- and it relates to how we think about Molnupiravir scientifically in the pandemic's phase, and there's going to be an endemic phase. And potentially, there could be other phases after that. But for the pandemic phase, I just want to emphasize we have the move out trial, and then we'll have to see the potential in the move ahead to see whether we both have a treatment and a prophylaxis. In the endemic phase, when the pandemic and what received, it's highly likely that SARS-CoV-2 will become an endemic infection, and we all have to recognize and that's related to the previous question during this phase, there will be a large reservoir of individual across the globe, with high copy numbers of virus -- viruses in many of these individuals that may lead to a constant brewing of variants. So, this question of resistance becomes very important. It is important to emphasize that Molnupiravir has an extremely high barrier to resistance. It has broad efficacy across all SARS-CoV-2 variants to-date and in our pre -clinical study and pre -clinical studies of others, it not only has a broad efficacy across SARS-CoV-2 variants, but a broad variety of RNA viruses. And probably the broadest than other -- than all other current mechanisms that we know being developed. I should emphasize, this high barrier to resistance is critically important, both in the pandemic and the endemic phase, as has been highlighted. And I need to emphasize, for this reason, we prioritized Molnupiravir over other programs, including an internal protease inhibitor given the paramount importance we place on ensuring the highest barrier to resistance, given where we are in the world right now.

Great. Thank you, Andrew. Next question, please, Operator.

Thank you. First -- next we have Carter Gould from Barclays. Your line is open.

Hey, guys. I -- good morning. Thanks for taking the question. Unsurprisingly, I'm going to focus on Molnupiravir too. I guess maybe for Frank and Caroline. I'm just trying to understand exactly kind of what's baked into that guidance in terms of what's being distributed for next year between your supply crossing that with the -- to your point, the supplying sort of low and middle-income countries with through the MPP. I acknowledge that there's going to be tiered pricing, but it seems like you'd still becoming far short of distributing your full capacity. So, any color on that front would be helpful.

Yeah Carter, this is Frank. I'll start and see if Caroline wants to add anything. So, in our assumptions and in -- appreciate this is a very fluid situation. We do assume an early use authorization in December this year, and we are including the contracts that we already have in place as well as those that are underway. So, we are comfortable with that $5 to $7 billion range through '22. And just to reemphasize, the number's based on the agreements we've signed, those in line of sight, and others that have high probability of execution. Couple of other things is we've mentioned, and Rob reiterated, we will produce 10 million courses of therapy by the end of '21 and are committed to at least doubling that in '22. Our focus initially for important that it's on treatment with COVID-19. You mentioned the broad global access which does come with global tiered pricing around the world. That's an important aspect, that the pricing will be tiered based on affordability measures. If our post-exposure prophylactic trial is successful as Dean was highlighting with an expected readout in spring, there is potential outside to these estimates. Furthermore, throughout 2022, we do not assume to your question in all of the suppliers use. As such, we have the ability to fulfill additional demand. We also do assume that there will be other oral anti - viral in the market and we'll have to see how that unfolds and we'll look forward to providing you some additional detail and clarity is we want to earn more over the next couple of months.

Great. Thank you, Carter, next question, please, Grace.

Thank you. Next, we have Steve Scala from Cowen. Your line is open.

Thank you. Merck views its competitive position in Pneumococcal vaccines as strong, but ACIP did not appear to agree, viewing the cost benefit of the 20 valent as superior, even when assuming it was ineffective against 0-type 3. So where does Merck think ACIP errored, and how does Merck change that narrative? Thank you.

First, we're very confident of our V1 for maximum events. There’re 2 places that we're advancing. It's in adult and pediatric. As you know, the pediatric market and I'll let Frank speak to it is quite robust market and we're advancing our program. We have submitted to the FDA, and we hope to hear back from them in short order so we're very focused in the pediatric. In relationship to the adult, the critical issue for us in relationship to GARDASIL is that we -- as I said in the prepared comments, I think it's very important to give the best coverage in terms of serotypes, but not just by immunogenicity, by actually studying clinical events, especially in those patients who are compromised or at risk or have some other condition that might increase their susceptibility to have invasive pneumococcal disease. And we think that clinical data and the way that we've studied it in these patient populations directly, we have not extrapolated from immunogenicity. We've actually studied it. It's something that's critically important as one looks at the true efficacy about vaccine. Frank, did you want to answer?

The only thing I'll add is actually we were very pleased that it was unanimous approval for the sequence of that events and PNEUMOVAX.A nd we need to feel as though that the sequence offers patients really with the broadest coverage with strong immune responses against several types that are responsible for 2/3 of Pneumococcal disease in adults, as well as the ACIP did highlight that the regimen was both cost effective as well as cost saving in the 65+ patient population. And then as Dean mentioned, we're also really excited about the opportunity for VAC events in the pediatric segment, which we believe is the larger market opportunity. So overall from our perspective, we feel really good about the ACIP recommendation.

Thank you, Steve. Next question, please Operator.

Thank you. Next, we have Geoff Meacham from Bank of America. Your line is open.

Morning, guys. Thank s for the question. You touched on a little bit with Molnupiravir during the first oral, but how do you expect play out commercially versus the booster strategy for vaccines? Would you expect any more formal guidelines from CDC or other [Indiscernible] about how Molnupiravir fits into the algorithm? Thank you.

I'll maybe try this. Geoff, I apologize. You were kind of garbled. I'll repeat what I think your question was, and then you can clarify if I got it wrong. I think your question was, this is the first oral antiviral. But obviously, we continue to have out there vaccines that are important as really the first line, and do we think there is any discussion on how this will fit into the regimen. I don't think we can really comment on how advisory committees, the FDA or others, and the CDC would look at that. But what I will tell you from our perspective, that first and foremost, people should be vaccinated. That it continues to believe what we think is the right answer. We see our therapy as something that is an important addition to the armamentarium. And obviously, there are places where people cannot get the vaccine or unfortunately as people get vaccinated and have breakthrough virus. So, there's definitely a need for this, but it is in collaboration as a complement to the vaccine and not in place of it. That's our perspective. We'll let the government speak to their own.

Great. Thank you, Geoff. Next question, please, Grace.

Thank you. Next, we have Chris Schott from JP Morgan. Your line is open.

Great. Thanks so much for the question. I'm just trying to get my hands around GARDASIL and the results in the quarter. So, can you clarify or quantify a little bit how much of the $2 billion in sales this quarter was stocking versus underlying demand? And maybe more broadly, are we still in a position where demand is exceeding supply, I guess on a global basis as we think about the recent capacity expansion? And I guess I'm trying to get my hands around, will there be another step-up in sales for this franchise as we look out to 2023 and beyond with the new facility coming online or is the capacity efforts you've made so far addressing most of the demand that's out there? Thanks so much.

So, Chris this is Caroline. I'll start and I'll hand over to Frank. So, in the quarter, as you note, we've had an exceptional quarter and that's driven by strong global demand and the step-up we have in supply. We also did benefit from CDC timing, and that was approximately 125 million of buy-in in the third quarter of this year. And that can trough to a buyout actually, in the third quarter of 2020. So, year-over-year, we feel we've benefited by approximately a 180 million to the results. Now in terms of how we see this going forward, we're very excited about the opportunity, We see opportunity for increased supply through '22 and beyond as we see the other capacity come online, but let me hand over to Frank to talk about the demand that we have.

Yeah, Chris, thanks for the question. A couple of other things that I do want to highlight as you think about GARDASIL, and this is something we've been discussing for a while, is that both the near-term results, as you mentioned, with the long-term prospects. First, I want to highlight that only 9% of the -- we see the eligible cohort globally has been vaccinated. So, Chris, I'll start there and say this, we still have significant opportunity. And if you think about markets such as China, if you think about the approval in Japan, if you think about the gender-neutral opportunities that we have in Europe, as well as other age cohorts in adult, mid-adult in the U.S. because we feel that there is significant opportunity for continued GARDASIL growth. As you saw, a step-up in our supply, we will continue to see that. It'll be a little bit more modest pace in next year, but rest assured as we bring on the 2 new bulk manufacturing facilities in '23. This is why we feel that the long-term growth prospects for GARDASIL, are very significantly. It'll to be a key growth driver for the Company going forward.

Thank you, Chris, next question, please. Grace.

Thank you. Next up, we have Tim Anderson from Wolfe Research. Your line is open.

Thank you. Question on additional M&A. So maybe for Rob. On the Acceleron Investor Clay you held, I asked whether Merck would do more M&A even if it meant taking a rating debt downgrade. And you were very frank in your answer and you said yes. But the Company has not been willing to quantify what debt, additional debt that would potentially be that would trigger downgrade. My understanding is that another $10 billion cash deal would be enough to trigger a one notch downgrade. And if there's something like a $30 billion cash deal, that could be a two-notch downgrade. So, my new question here is, would Merck actually do the deal big enough to cause a two-notch rating downgrade? Thank you.

I appreciate the question. I would start more high level. Do we continue to pursue additional business development? The answer is yes. It will be driven as it has always been, based on what we see as a compelling scientific opportunity, where we see science addressing an unmet need that is strategically aligned with us and where we can bring value. So that is unchanged. As we look at capacity, I would just say, we believe we have the firepower to do, and frankly, any deal that's out there that we would have strategic interest in doing. The balance sheet will not be a brake limiter for us; we have very strong balance sheet capacity. I don't think we want to get into trying to get specifics. Some of your numbers frankly, we're quite a bit off actually, but I don't want to start getting into those kinds specifically because it depends on rating agencies that depends on the target. Cash flow is coming from the target. So, with that, I think the important messages, Balance Sheet capacity is not going to build it 100 for us.

Thank you, Tim, next question, please Grace.

Next up we have Seamus Fernandez from Guggenheim. Your line is open.

Great. Thanks for the question. So just a quick one on the earlier stage pipeline, I'm a little surprised you guys are presenting your first oral PCSK9 inhibitor in a late breaker at AHA in 2 weeks. But it isn't included in your pipeline summary. Could you just help us understand why not? And just as a follow-up to that. When might we hear more about the earlier stage pipeline? Will it be at an R&D day in 2022? What's the right time to start showing a little bit more of the earlier stage pipeline that Merck's been building over the last 3 to 4 years via acquisition and then internally? Thanks.

This is Rob. Maybe I'll let Dean just comment specifically on the oral CPF, the oral PCSK9 than I can give a comment on the additional transparency question-and-answer.

Specifically in relationship to the PCSK9, it is going to American Heart Association. It is slipping into Phase 2 and that's why we opening our pipeline leave it at Phase 2, but we're trying to demonstrate increased transparency by showing something that's about to enter that, the presentation at the American Heart Association, I think will be well attended. I think trying to create an oral PCSK9 has been a holy grail in the Cardiovascular field for some time and has not been achieved, and we believe we have achieved it. It is about that product, but it's also about the ability of Merck to do things that other people can't do. And when one looks at how we created that molecule, one can immediately ask yourself, wow, what is their capacity? What's that technology that allows them to do that for PCSK9? What other targets could they be doing as well? Rob?

Thank you, and as Dean highlighted, we turned our views as things move from Phase 1 into Phase 2. That's when we will start discussing it. So, this is just in that process and I would highlight what Dean did get into, but there's a lot of -- we've other assets and Cardiovascular space that are also either have moved or are moving into Phase 2. That's why we really see our Cardiovascular pipeline as a growing area of excitement and strength and why we were so excited about the complementary nature that Acceleron is to that pipeline. And as you asked about the transparency, our intention, the next area we'd like to highlight is Cardiovascular, because I can tell you I'm excited about what we have. We've got a lot going on, but I don't think it's appreciated. Obviously, we would like to wait to see the Acceleron deal completed so we can include their assets in that discussion. And that'll come as soon as we can figure out when that will happen, either later this year or early next year. Beyond that, I was very pleased with what we did when we gave added visibility to our HIV pipeline, the excitement we have around [Indiscernible]. That's a foundational drug. oncology continues to have just multiple shots on goal, both with KEYTRUDA and a growing number of new mechanisms. We've highlighted that. And once we get past the Cardiovascular, I assume we will start to talk about our CNS portfolio because we also have a lot in the neurology space. I think it's pretty exciting. So, our view is to do it area by area as things start to move into the space to a realm. And we'll bring it forward as quickly as I can with the Cardiovascular being first once Acceleron has done.

Thank you, Seamus. It's a little past 9. I think we have time for 1 more question. Next question, please. Grace.

All right. Your last question comes from the line of Louise Chen from Cantor. Your line is open.

Hi, thanks for taking my question here. So, there are several players trying to bring lower-price checkpoint inhibitors to the market. Do you believe that these discounted pricing strategies will have any traction, why or why not? Thank you.

Hey Louise, this is Frank. I'll take that from a couple of different angles. I know there's been discussion there and I first want to make sure that we really continue to emphasize that oncology we see, is really data-driven, and the importance of strong clinical data, and I think you have seen that position as well, and also the wall of data that we've established with a product like KEYTRUDA, with 33 indications right now, and just the familiarity and the growth that we're seeing across so many different cancer types that I was highlighting, we feel we're very well-positioned. We also think that the regulatory hurdle for new entrants increases with additional KEYTRUDA approval., And is positioned to contain you to gain experience. We think that also you would have to have a broader structural change would be required in the U.S. to adopt broadly. So, our view is we'll continue to monitor the competitive landscape as we always do, but we feel very confident in contributed and our growth prospects going forward.

Great, thanks, Louise. Rob, any final points?

Maybe just a couple of points. First, I want to thank and recognize our Merck employees across the globe for their hard work and dedication. With the pandemic the way we've been able to execute that really. I think shows the best of who we are and I couldn't be more proud across all elements of our business, clinically, commercially, manufacturing, it's really phenomenal, so I do want to first recognize them because I think that's important. And hopefully what you took from the call is this is an exciting time at Merck. We really have growing momentum and I can tell you growing confidence that we have the ability to grow not only in the near-term, but a growing portfolio of assets that set us up to sustainably be an important contributor to human health and to continue to deliver significant value for our shareholders. We're more focused Company or a faster growing Company. We're working with urgency to achieve our mission and over for patients and shareholders. So hopefully that came through. And I'm also quite pleased with the amount of progress we've made in a short period of time. You've heard today good developments across businesses, but development, good developments in delivering an incredibly strong quarter, moving fast with what we're doing with Molnupiravir. Great results coming with Islatravir and our broader oncology portfolio. So, we're firing on all cylinders and I am confident and proud of where we are and I thank you for your time

Thank you, presenters.

Thank you very much.

Thank you, this concludes today's conference call. Thank you all for joining. You may now all disconnect.