Good morning. My name is Carlo and I will be your conference operator today. At this time, I would like to welcome everyone to the Merck & Company Quarter Four 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 now like to turn the call over to Peter Dannenbaum, VP of Investor Relations. Please go ahead.

Thank you, Carlo, and good morning. Welcome to Merck's fourth quarter 2019 conference call. Today, I'm joined by Ken Frazier, our Chairman and Chief Executive Officer; Rob Davis, our Chief Financial Officer; Dr. Roger Perlmutter, President of Merck Research Labs; and Kevin Ali, who will be named Chief Executive Officer of the new company we've announced today, each will have prepared remarks. In addition, I'm also joined by Frank Clyburn, our Chief Commercial Officer; and Mike Nally, our Chief Marketing Officer, who will be available for the Q&A portion of the call. Before I turn the call over to Ken, 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've excluded these from our non-GAAP results and provide a reconciliation in our press release. We have also provided a table in our press release to help you understand the sales in the quarter for the business units and products. I'd like to remind you that some of the statements that we make during today's call may be considered forward-looking statements within the meaning of the safe harbor provision of the U.S. Private 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 2018 10-K 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. You can see our SEC filings as well as today's earnings release on merck.com. We have also posted a presentation to the Investors section of merck.com, which includes some of the highlights from our results and announcements. With that, I'd like to turn the call over to Ken.

Thank you, Peter. We're very pleased to speak with you this morning as we close out what we consider to be an exceptional year for Merck. And we're excited to announce our intention to create two leading growth companies through the spinoff of our Women’s Health, Legacy Brands and Biosimilar Products into a new company. As you can see from our results and our 2020 guidance, Merck had an extraordinary year and is in a position of operational and financial strength, driven by strong execution of our strategy and focus on our key growth drivers and innovative pipeline. It is this position of strength, born of that focus that gives us the confidence to do what we believe will best position us to deliver even greater value to patients and shareholders. Throughout my entire tenure as CEO, we have consistently focused on science as core to our strategy to not only benefit the most patients, but also as a means of creating the most value. As you’ve seen, Merck's portfolio has evolved from one focus largely on primary care products to one focus on oncology, vaccines, hospital and animal health. It is this purposeful shift, coupled with greater prioritization and focus on key growth drivers that has led to the unprecedented growth that we are now experiencing. Going forward, we see even greater opportunities to invest behind our innovative growth drivers. In placing greater focus and prioritization behind these products, we must also think carefully about how to make the best possible use of the remainder of our expansive Human Health portfolio, which is comprised of more than 160 products in total. Our responsibility to patients and shareholders has led us to think about how we can maximize the impact of this vast array of Human Health products. Therefore, after…

Thanks, Ken, and good morning, everyone. I'm excited to speak to you this morning about our 2019 results, as well as our decision to spin off a portion of our Human Health business, a decision that will enhance the value of both Merck and NewCo. 2019 was a year of exceptional growth for our business with revenues increasing 13% and non-GAAP EPS increasing 21%, excluding the impact of foreign exchange. Our strong performance reflects the continued execution of our science-led strategy, and we expect our business momentum to continue, particularly as we enhance our focus on our key growth drivers through the spinoff. I'll start by highlighting our strong fourth quarter results before providing more details on the transaction and 2020 guidance. Total Company revenues were $11.9 billion in the quarter, an increase of 8% year-over-year, or 9% excluding the negative impact from foreign currency. Both our Human Health and Animal Health divisions contributed to the growth this quarter. The remainder of my comments pertaining to sales will be on an ex-exchange basis. Our Human Health revenues grew 8%, led by products in oncology and hospital. In oncology, KEYTRUDA fourth quarter sales were $3.1 billion and for the full year sales exceeded $11 billion, representing 58% growth versus 2018. In the U.S., growth was driven by strong demand across all indications. KEYTRUDA continues to lead across many indications, including lung, bladder, and head and neck cancers with strong momentum in adjuvant melanoma and renal cell carcinoma where we're seeing strong uptake across all patient subgroups. Outside the U.S., KEYTRUDA sales in the quarter grew 15%, driven by lung globally was reimbursement for KEYNOTE-189 now secured across all major markets in the EU, and strong uptake in lung, following approvals in Japan and China. We're also seeing positive uptake from early…

Thanks, Rob. Looking back on 2019 and in particular on our fourth quarter results, there is much to celebrate. In December, our KEYNOTE-057 data were reviewed at an FDA Oncologic Drugs Advisory Committee meeting, which was followed three weeks later by FDA approval of KEYTRUDA as monotherapy for the treatment of certain patients with high risk, non-muscle invasive bladder cancer. This represents the 23rd FDA-approved indication for KEYTRUDA, broadening still further the benefit that can be expected from the use of KEYTRUDA in the urologic setting. KEYTRUDA also gained three new approvals in Japan during the fourth quarter as combination therapy and the first line treatment of advanced renal cell carcinoma based on the KEYNOTE-426 study and for the first line treatment of metastatic squamous cell carcinoma of the head and neck, either as monotherapy or when combined with chemotherapy, based on results of the KEYNOTE-048 trial. The KEYNOTE-048 data also permitted approval of KEYTRUDA in Europe with the similar indication. Finally, we gained approval of KEYTRUDA in China for the treatment of metastatic squamous cell carcinoma of the lung in combination with chemotherapy, based on data obtained in the KEYNOTE-407 study. Substantial progress was also made in the registration of Lynparza, our leading PARP inhibitor that we are developing in collaboration with colleagues at AstraZeneca. At the December FDA Oncologic Drugs Advisory Committee, a majority of committee members supported the use of Lynparza as first line maintenance therapy for patients with germline BRCA-mutated metastatic pancreatic cancer whose disease had not progress after at least 16 weeks of first line platinum-based chemotherapy, all based on data from the Phase 3 POLO trial, which demonstrated a 47% reduction in the risk of disease progression or death in the Lynparza treatment arm. FDA granted approval for Lynparza in this setting at the…

Thank you, Roger. And before turning the call over to Kevin, I'd like to take a few minutes to share with you some details on his background. Kevin brings a wealth of knowledge to NewCo, based on three decades of pharmaceutical and commercial experience at Merck. His experience ranges from leading different regions including our entire international Human Health business, and the emerging markets region to leading markets such as Germany and Turkey. Most recently, Kevin has been instrumental in evaluating Merck's options to optimize the entire Human Health portfolio and in envisioning what success looks like for NewCo, while providing invaluable counsel to me and the rest of the senior management team. I'm confident that under Kevin's leadership, NewCo will reach its full potential and drive great value for patients, shareholders and employees. And with that, I'd like to turn the call over to Kevin.

Thanks, Ken, and good morning. I'm excited to share with you today the creation of our new company, which we believe has a remarkable opportunity to unleash the potential of a leading portfolio of assets in women's health, a rapidly growing biosimilars business and a portfolio of trusted and medically important legacy brands. NewCo revenue was expected to be flat to declining through 2024 within Merck due to limited investment focus. However, we believe that by allocating the appropriate resources and by focusing management's attention, NewCo will achieve sustainable growth and create value outside of Merck. Although revenues are expected to decline in 2021 versus 2020 to a base of approximately $6 billion to $6.5 billion, largely due to the loss of exclusivities of Zetia in Japan, and NuvaRing in the U.S. The new company will be well-positioned to achieve low-single-digit revenue growth off of that base. As no new LOEs loom and we have identified lifecycle management and commercial investment opportunities, some already underway. NewCo will have a strong global scale and geographic diversification and as a standalone entity will be better positioned to capitalize on attractive opportunities across this portfolio. NewCo will pursue global leadership and sustainable growth in women's health to its growing contraceptive and fertility business including Nexplanon, which grew 14% in 2019, and is the leading implantable long-acting reversible contraceptive worldwide with U.S. patent protection through 2027. In fact, we expect Nexplanon to be our first billion-dollar women's health product. The growing $40 billion women's health market is highly fragmented, with over 400 products in development industry-wide. NewCo will be well-positioned to capitalize on this attractive market opportunity to become an industry leader through investments in both organic growth and business development opportunities, and to deliver better and more innovative and holistic care to women.…

Thank you, Kevin. We recognize today's upfront comments ran longer than normal. So, we're prepared to extend the call beyond 9 a.m. if necessary. So, Carlo, will you please line up the queue for Q&A?

Thank you, sir. [Operator Instructions] Our first question is from Chris Schott from J.P. Morgan. Please go ahead.

Great. Thanks very much for the questions. Obviously, a lot of news there today. I just had two really, both related to the spin. I guess, first on this. You mentioned you've been considering a deal like this or some structure for these assets for quite some time. I guess, why now on the timing? Is there something that’s either happened with the business or the pipeline that made this -- make particular sense now versus I guess when you've worked at this in the past? And my second question is, I just want to make sure I'm understanding the $1.5 billion operating synergies correctly. Should we think about that as a net reduction in OpEx relative to what the combined Company would have spent or is that savings that goes to RemainCo and should be balanced against some of the stand-up costs that you're referring do with the NewCo? Thanks very much.

This is Ken Frazier. Let me start with the why now. The reason why we're doing this now is that our fundamental and financial strength, which is being driven by the focus on our best opportunities for growth, allows us now to do what’s strategically correct for the company in the long term. This is about taking actions today that will assure the long-term growth and viability of Merck, as well as allowing products that no longer fit into our strategic framework to prosper in a new organizational structure. So, from our standpoint, this is the right time. A few years ago, when we were looking at this, we saw the opportunity, but for example, the cash flow generation of our legacy product was being employed at that time and standing up our oncology business from which we grew from the ground up, and as you know, have been extremely successful. That success has been due to our ability to allocate capital to a business that we didn't have before and getting the entire organization focused and aligned around an opportunity that we had around KEYTRUDA and other compounds behind KEYTRUDA. So, that is why we can do it now. And I said before, we are confident about our long-term growth prospects. And one of the ways in which we try to manifest that is by saying we will maintain and grow the dividend on the Merck side, irrespective of losing these brands.

Okay. Rob on the efficiencies?

Good morning, Chris. On your question, so the way you should think about is the $1.5 trillion of operating efficiencies, our incremental cost savings in Merck after the spin-off is completed, the stand up costs that are required to support the new companies are really contemplated -- if you take the fact that we commented that there's 45% operating margin for the new company within Merck and it goes to 35%, roughly mid-30s after the stand up. That 10 percentage point delta is really the stand up costs. So, those are not -- those are separate independent from the $1.5 billion of net benefits, net synergies that will be joined by Merck going forward in its operating results.

Next question, please, Carlo?

Next question is from Tim Anderson from Wolfe Research. Go ahead, please.

Thank you. A couple of questions on spin and then a science question. On the new company to be spun out, will that be doing real R&D and have its own R&D engine? When you talk about sustainable growth, I'm just wondering if part of that’s going to come from genuine R&D? And then, on RemainCo, updated views on Animal Health. Should we assume that this new split means that the remaining parent Merck company is even more likely than ever to keep Animal Health in perpetuity? And then, last question is on the adjuvant IO opportunity. Roger, in my past discussions with you, you've been highly confident the PD-1s will work in adjutant setting. Recently, we saw Roche failed in bladder. There's been some timeline slippage, we haven't seen any adjuvant trial timelines pulled forward, no trial stopped at an interim, unlike we have with metastatic disease in the PD-1. So, my question to you is, are you still highly confident that PD-1s are going to work broadly across tumor types and adjuvant?

Thanks. Kevin, on the research and development capabilities of NewCo.

Thanks. Good morning, Tim. Yes. NewCo will have a high quality development capability, and is really well-positioned as a partner of choice for other biopharmaceutical innovators who are looking to realize commercial growth through our global scale and presence in selected international market to increase patient access. Over time, NewCo will build a research capability in selected therapeutic areas starting with women's health as a core pillar of its business development strategy, and then will move further from there.

Tim, on your question about Animal Health, I'll start by saying, we never say what's going to happen in perpetuity, because we regularly review our entire portfolio and make decisions about which parts of that portfolio belong in our portfolio and which ones would be better off. As we look at our Animal Health, we believe, if you look at its growth, if you look at its profitability, we continue to believe that we are in effect advantaged owners of that business going forward. We also believe that that is an important key growth pillar that actually helps us in the long run. As you know, there are ups and downs in the pharmaceutical business. And having a business like vaccines, having a business like Animal Health gives us the long-term stability that actually allows us to confidently pursue our R&D mission.

Okay. Roger, on adjuvant?

Tim, on the question of the immuno-oncology in the adjuvant setting, I can't speak generally about PD-L1 and PD1 antagonists, but I can talk about KEYTRUDA. First of all, of course KEYTRUDA is already effective in the adjuvant setting as we’ve shown in melanoma. And we also showed the effects in the neoadjuvant setting in breast cancer in the I-SPY 2 study and as well in the 522 study most recently, and that is a combined neoadjuvant, adjuvant study and we'll be seeing the adjuvant data in not too long time. And you shouldn't really expect adjuvant data to be pulled forward, because by definition, patients who are receiving adjuvant therapy are patients who have better overall survival over a longer period of time. So, one expects to see those adjuvant results roll out with a more defined cadence. And I think that's exactly what we'll see. And based on our success in two prior settings, I would think KEYTRUDA should be successful in these settings as well, in general. It works better when used earlier.

Next question is from Steve Scala of Cowen. Go ahead, please.

One of the concerns investors have with Merck is the view that its outlook is heavily dependent on KEYTRUDA, and formation of NewCo would seem to increase this risk and concern. So, Merck appears to not agree that this is a concern, and I'm wondering if you can elaborate on why. And then, second, what was the rationale for leaving Januvia within Merck as opposed to NewCo? It seems placing Januvia within NewCo would have made Merck’s outlook appreciably clear going forward. Thank you very much.

Well, let me start on Januvia question. We continue to believe that our diabetes franchise is going to be an important contributor to Merck now and into the future. We're also continuing to do significant research in the whole cardiometabolic area. So, that's an area of focus for us going forward. In terms of the issue around KEYTRUDA concentration risk, we are mindful of that. We think KEYTRUDA revenues as a proportion of total revenues only increase by a small amount, because of this. I think, the most important thing that I would say about KEYTRUDA is that right now we continue to see the benefits of our focus both in terms of R&D and commercial execution going forward. We see it as driving more growth going forward for the Company. But we also see the benefits of our other opportunities in oncology. We have more than KEYTRUDA, we have Lenvima and Lynparza. We also have 20 molecules behind that. We also have our vaccines business, our hospital and specialty business. So, we're looking to optimize our entire portfolio and augment our pipeline through business development. That's how we see our future growth, not so much these brands, which as Kevin said, left to their own, would probably decline more steeply than they are in the NewCo.

Great. Rob, anything to add?

Yes. Steve, just to kind of build on your point about why Januvia in Merck as opposed to NewCo. As we look at it, clearly, we continue to benefit from the fundamental cash flow and strength that that business gives. While it’s not a growing business, it still is generating a lot of cash flow. But, in the near term, as we approach LOE, it will continue to be important for Merck. This is an important brand for us. And frankly, if you look at the NewCo company, while the loss of exclusive to Merck frankly does not affect our ability to deliver growth, as we've already commented, even through the loss of exclusivity in 2023, 2024, we grow each and every year through that period. So, we're able to absorb the loss of exclusivity, benefit from the cash now, that type of clip would be insurmountable to the new company. And then, finally, and Roger can comment on it in more detail. But, we continue to do some pretty interesting science in the cardiometabolic area. And so, exciting opportunities are there. So, continue to see from a scientific perspective fit as well. For all of those reasons, we felt keeping it within Merck made more sense than moving that over to the NewCo.

Next question is from Andrew Baum of Citi. Go ahead, please.

Couple of questions, please. Firstly, you initiated your islatravir dual oral combination trials. Is there any possibility within that? And being able to differentiate your combination versus Victoza on the back of less weight gain, given the absence of an integrase inhibitor? And whilst you’re waiting for the long-acting trials to complete, does that provide any kind of commercial advantage? And the second question relates to Tigit. One of your competitors Roche has indicated they are opening a Phase 3 program. They've already run a head to head data in combination with that PD-L1 and non-small cell lung. I know that you have a program ongoing and have had for some time. Could you talk to your relative levels of excitement with the molecule and perhaps give us some timelines, and when it may be able to enter registration trials? Thank you.

Roger?

First of all, with respect to the islatravir combination, in realty, we really have to wait for the data. I think that we're very confident in the behavior of islatravir, which we demonstrated through our reasonably large Phase 2 studies and also the work that we’ve done with impactable person. [Ph] It's a terrific molecule and behaves extremely well. How it will behave with this in combination study? We have pretty good evidence that indicates to us that it will be a leading combination, and especially valuable in treatment. We also know islatravir either by itself or potential combination is a good preventive regimen. But, we need to see the data from all of those. And that's what we'll be getting. And with regard to what I call Tigit, but you can call Tigit. We do have a program. We have been working on this for some time. We have studies going on where we had tried to ask a question of whether this molecule in combination with KEYTRUDA behaves better than KEYTRUDA alone, and is there any circumstance under which it can be used? We recognized that KEYTRUDA is a very impressive compound in a whole variety of different settings. And we have to find the right place in which to use it. So, we're enthusiastic about it, and we're moving forward.

Our next question is from Louise Chen of Cantor. Go ahead, please.

Hi. Thanks for taking my question. So, my first question to you is that you noted in the call that you're more confident than consensus on every metric through 2024. Just wondering if you could elaborate more on what you think the street is missing here. And then, second question is just on KEYTRUDA in Japan. Curious what kind of impact do you assume for price cuts this year for KEYTRUDA in Japan? And is there another potential price cut coming? Thank you.

Rob?

Yes. Louise, this is Rob. Thanks for the question. Really, if you look at the comments that Ken made, he said we feel confident that the Street under-appreciates our revenue, our operating margins and our EPS growth as we look forward through time. And if you look at in the components, clearly on revenue, we continue to believe all of our growth pillars have meaningful growth opportunity, and in most cases, continue to be underappreciated across oncology platform, within the vaccines platform, given GARDASIL and Animal Health, just to name a few. So that story, which we've been talking to you about over the last several quarters, continues. And then, as you look beyond that, clearly with the spinoff, getting up to 1 percentage point improvement in our growth rate as a result the spin itself, that's even further growth that’s not appreciated, not to mention the fact that we think through core focus and really directed efforts by our leadership team, we can run at an even faster growth. So, that is an important part as well. And then, as you look an operating margin, today, we've indicated that by 2024 or in 2024, we expect operating margins now as a result of what this spin enables, which enabling $1.5 billion dollars of incremental cost efficiency on top of the already improving natural mix we've been benefiting from in our business, we're going to achieve an operating margin of greater than 40% in 2024. And if you take that acceleration in operating margin, combined it with potentially accelerated EPS, when you think about us deploying $8 billion to $9 billion of proceeds from this transaction, if you put that share repurchase for instance, you even get further acceleration. So, as you look out to 2024, that's why across those select factors, we believe this under-appreciates revenue under-appreciates operating margin, under-appreciates EPS growth.

And Frank on the Japanese price cuts?

Hi Louise, it's Frank. In Japan, we did see or we will be seeing, I should say, in February of this year, a huge sales re-pricing of 17.5%. We’ve seen significant strong performance based off of our lung cancer indications in Japan. And because of the sales projection, February will see the price reduced 17.5%. It's also important to note that we will face another significant reduction in April. That significant reduction is going to be within the same range as the first cut in February. Important to note that will have an impact likely on our Q1 results in Japan, but also as we take a step back, when you look at the rollout of renal cell carcinoma and our other indications in Japan, we do believe despite the price cuts, over time, we will be able to grow in Japan. And I want to reinforce that if we elevate outside of Japan, we still see very significant growth in 2020 and beyond as we continue to roll out many indications globally, very strong uptake continuing to see in Europe. And as Roger mentioned, we now have 23 indications in the U.S. So, we feel very good about our outlook for KEYTRUDA. Clearly, the Japan re-pricing will have the near-term impact in Japan, we’re confident, as we go forward.

Next one is from Umer Raffat of Evercore.

Hi. Thanks so much for taking my questions and I’d appreciate you bearing with me a little bit on it. I guess, let me start with this, a simple one, which is, can you confirm that the standalone EPS goes down by about $1? That's first. Second, if I add up Women's Health, cardiology and diversified, that's about $6 billion, which is roughly what you're saying is what's being divested to the NewCo. But, if the goal is to focus on the innovative and pharma in the RemainCo, I noticed there's a $5 billion line for your other pharma, which is not being included. And I'm curious why that is. And finally, I think it's very interesting that you're not doing a split, you're doing a spin, very specifically. And I also noticed when you talk about the proceeds, you're mentioning BizDev, before you mentioned share repurchase. So, it almost seems to me that they might possibly be interested in replacing that last dollar. So, my question is, are you looking at a company which is more on the pipeline side or is the focus more on a accretive deal, which gets to that dollar EPS back immediately? Thank you very much.

Yes. Thanks for the question, Umer. So, as you look at thinking about what is the subtraction, if you will, away from Merck by pulling out this business, and I know the math you're doing to get to roughly the dollar. The only thing I would advise you on is I don't think you're giving any credit for the operating efficiencies, the $1.5 billion which we said, we will give relatively. So, that's $500 million, even in 2021, the first year, which is I think where your math is coming from, and you're not giving any credit to what we're doing with $8 billion to $9 billion of cash proceeds. But, if you deploy that to share repurchase, in reality, that dollar you're quoting, then goes down to $0.60 to $0.70 in the range. So, thinking of in terms of percentage, you're closer to 15%. And we believe the answer is probably closer to 10%.

Great. And Umer asked as well, what's included in NewCo?

Yes. So, if you look at the other line, the other pharma line picks up a lot of our hospital and specialty products and picks up our products like ZERBAXA, which is still early in its launch, but a product, which we are very excited about. So, as we look at the portfolio, those products that are sitting in the hospital's specialty space are ones that we continue to believe long-term create value for us, and we want it to maintain. And then, there's other to be launched revenue numbers sitting in their or products that are smaller in there as well. So, it really is the profile of products different than what we put into the NewCo and are really aligned with the core growth drivers that we've already identified.

And then, I think, Umer’s last question was capital allocation priorities combined with the question about what our interest in BD might be. So, let's start with Rob and then turn it over to Ken.

So, if you look at the capital allocation priorities, they really remain unchanged. First and foremost, we're going to ensure we appropriately fund research and development. We're going to fund the opportunity to launch new products. And we're going to fund the capacity expansion that we have underway to ensure we have the capacity to meet what is very strong demand across all of our growth pillars in vaccines, oncology and animal health. We remain committed to the dividend. We talked about that. You heard today, very importantly. We are not lowering the dividends as a result of the spin-off of NewCo. We're going to hold our dividend at $2.44, which is in 2020, and they grow it off of that base with the goal to get to 47% to 50% as a payout ratio. So, you're actually going to see a maintained dividend growing over time. And then, you have the benefit of the incremental dividend that NewCo is going to have. So, all-in-all, you should have overall more dividend, if you hold those stocks that we do today. And then, finally, as we've always said, our goal is to use excess cash flow first and foremost for value-creating business development. To the extent though we can’t find those or we don't find ones that bring us a combination of strategy and value, we will return excess cash to shareholders moving forward. And specifically, as you look at the $8 billion to $9 billion of special dividend we're going to receive from NewCo as result of this transaction, as we said in the comments, it will be deployed either to business development or to share repurchase and will not be used for debt pay-down. That's why we believe it’ll be accretive over time.

Umer, this is Ken. I think, you also asked about spin versus split. We chose spin, because we thought that was the quickest path and a tax efficient way of doing this for our shareholders. As it relates to business development, I'll just say, as we’ve always said, it's an important priority. And first and foremost, we are always looking for the best science and innovation that will drive long-term growth and value for shareholders. So, we're still very much focused on those deals right augment our pipeline. And you saw last year, we did a number of deals, about 80 transactions spanning licensing, technology deals and clinical collaborations. We’ll continue to look for those opportunities to augment our pipeline with the best science.

Next one is Geoff Meacham of Bank of America.

Just have a few. Rob, on the spin, I get the operating margin benefit to Merck longer term, but did I hear you right that op margins to be lower this year and post spin initially? And then, with freed up capital, does the spin effect where you guys have previously discussed on the moderation of R&D investments, looking to 2021, 2022? And then, Frank, real quick, you talked about the growth strategy in China for IO at this point with the NRDL decision in first line lung. I know you guys just got approval in this indication in November.

So, on your question about operating margin, if you look at what NewCo is within Merck today, it's about 45%. So, it's obviously higher than the Merck's operating margin. So, it will be initially normally dilutive, when we pull it out in the first year. But, importantly, because of the fact we are getting the operating efficiencies, starting even in the first year of $500 million and then growing with an additional $500 million year two, another $500 million year three, so cumulative $1.5 billion. That offsets a lot of that dilution. And from that when you look at it, it's only about 1 percentage point of dilution to our op margin in the first year. And then, very quickly, you're going to see our operating margins continue to grow. And by the time we get to over 40% by 2024, we will be at a rate higher than we would have achieved as a combined company, largely as a result of that $1.5 billion operating efficiency. And so, that was I think first question. The second one was what's happening with I think R&D as we look at going forward. So, we have never been capital constrained in what we're doing in R&D. What's driving the inflection point we talked about, which was the slowdown of growth in R&D in 2021 as a percent sales. It's still going to grow, it's going to grow, it’s just going to grow slower than sales in 2021. That inflection point is driven more by where we see the clinical programs at this is time. If we find opportunities to invest and I'm confident given the productivity that we’ve seen from the labs thus far that they very well might do that. We will obviously increase our investment as those opportunities present themselves. But as of right now, our expectation is that inflection point continues to happen in 2021.

Frank?

Geoff, in your question on China, I first wanted to make sure that we do mention that our primary focus is on ensuring the safety of our employees’ families and supporting the people of China. I think, that's on all of our minds and also the continuity of supply of our Human Health medicines and vaccines and products. And we're going to have to see how China evolves, will likely see some impact in Q1 to really to quantify. As far as your specific question on IO, our overall strategy, as we discussed, in particular, as we rollout in the self-pay market, we still feel very confident on our position. We are still the only IO therapy that's approved in non-small cell lung cancer. We recently got approval for KEYNOTE-407 in the squamous cell carcinoma population. And we feel as though we have a very significant opportunity in the self-pay market. And we've also adjusted our patient assistance programs in China to increase the affordability for patients that we're trying to provide access to as we move forward. So, we feel confident going forward in our growth prospects for KEYTRUDA in China.

Next one is Seamus Fernandez of Guggenheim. Your question, please?

Thanks for the question. So, maybe just a follow-up on one of Steve's questions. The concentration of the business -- Merck's business to KEYTRUDA going forward. Can you just talk a little bit about the competitive pressure points that could emerge going forward, to talk a little bit about China. But, there also are potential Chinese assets that could be introduced into the U.S. following successful lung cancer clinical program. Just trying to get a better sense of the growth opportunity for KEYTRUDA and where you see potential pressure points? And if you could also comment on some of the administration's efforts around international pricing, again, a potential risk point for KEYTRUDA that would be helpful. And then, just as a follow-up on for Roger. Roger, how quickly the Company emphasized a lot of vaccines, opportunities for the business going forward. But most of them were Phase 1. How quickly could we see some of those programs advancing and potentially coming to market? And maybe you could just tell us, which one or two you're most excited to see in the near term? Thanks.

Thanks. So, first, Frank, kind of the performance and outlook for KEYTRUDA.

Yes. So, on KEYTRUDA, as far as -- if we look back at 2019, we're, one, very pleased with our growth of 58% excluding exchange and almost $4 billion and eclipsing $11 billion in sales. We feel very well positioned as we've been saying with regards to KEYTRUDA, not only with regards to our significant penetration in non-small cell lung cancer within the U.S., but also the significant impact that we're having for patients with renal cell carcinoma, adjuvant melanoma, head and neck, as you heard Roger mention are recent approval non-muscle invasive bladder cancer. So, the breadth of our indications and the strength of our data, gives us a lot of confidence to continue to grow, in particular, not only in the U.S., but ex-U.S. and especially as we roll out our broader indications in non-small cell lung cancer. And we're now reimbursed in Europe in all markets for lung, which I see is an important aspect of our growth in 2020. The other thing I would add on the concentration piece too. I think, we tried to highlight that it’s not just about KEYTRUDA, it's Lynparza, it's Lenvima, it's our pipeline in oncology that we've discussed. We also feel very good about our vaccine performance this year. GARDASIL this year grew 21%, as well as our hospital and specialty products. We continue to see good growth with BRIDION. So, from a concentration perspective, we feel very confident on the portfolio, not only KEYTRUDA, but the breadth of opportunities that we have going forward.

Right. Ken, on pricing?

Okay. So, on that question specifically, we understand the administration's concerned that certain countries don't pay their fair share of the cost of innovation. We do keep continuing to make the point that incorporating additional price control is not the solution to the problem. We continue to work with the administration, the Congress and other stakeholders to provide a perspective. I think, patient groups are also providing very strong perspectives on these issues as it relates to that. But, if you take a step back and think about what we announced today, the reason why we're taking these kinds of proactive steps now is because we want to make sure that we position the Company for long-term growth and viability in the future environment. That's about being much more focused on innovation and it's about driving efficiency within our operating model. So, this is about staying ahead of the curve, rather than waiting until something happens in the pricing environment that we have to react to.

And Roger on vaccines?

Right. Seamus, thanks for the question. On vaccines, first of all, as you recognize, we have an enormously large program in pneumococcal conjugate vaccines with V114 program having 15 Phase 3 studies that are rolling out over the next 18, 24 months. We're going to see a lot of those studies coming this year in fact. And so, you’ll be hearing a lot of data from those studies, which will ultimately permit filing. So, that's a very near-term opportunity. We have a lot of enthusiasm about our dengue virus vaccine. That vaccine incidentally is -- we are collaborating with colleagues at Butantan, where they have a registration-enabling study ongoing. And that study will deliver results at some point. So, that's pretty exciting as well. In addition, of course, we have our CMV vaccine. We have a lot of interesting things going on, respiratory syncytial virus. And those programs are actually fairly advanced. So, things are moving along quite well. I can't fail to mention the fact that the demand for GARDASIL, GARDASIL 9 remains enormous. And we have invested a huge amount of capital together with our manufacturing colleagues in building the additional capability to meet that demand and that will be rolling out in not too longer time and it will be very important obviously for the Company.

Great. We have several more questioners in queue. We're going to have a hard stop at 9.15, but we're going to keep going. Next question, please?

Next one is from Daina Graybosch of SVB Leerink. Go ahead, please?

Thanks for the question. Two of them, first on NewCo. What do you see as the long-term relationship between NewCo and Merck? And then, the next question for Roger. As you reflect on all the internal and external immuno-oncology data that came out in 2019, what novel mechanisms are you most excited about, to add on top of KEYTRUDA to provide further benefit for patients?

Well, in terms of long-term relationship, that's to be decided as both companies look to their future and decide how they want to make sure that they optimize their best opportunities. So, I can't say anything other than what we've announced today in terms of the products that are going over. But, obviously what I would say about NewCo that makes me excited is I think they will have many of the same standards and values that Merck has going forward.

Roger?

Yes. Thanks for the question, Daina. In many respects, so things we're most excited about, you can tell by looking at the things that we're investing in. You can see that quite remarkably, the Lenvima and as it's been demonstrated in the endometrial cancer registration combination with KEYTRUDA most recently, but we've also seen really spectacular data in renal cell carcinoma, we presented those Phase 2 data, and we have ongoing Phase 3 data, demonstrate that the protein tyrosine kinase inhibitors with special characteristics can combine very effectively with KEYTRUDA. We also have data which we presented in combination with Lynparza that are very impressive. Let me have this very large set of new molecules, which -- some of which we referred to already that include antibodies directed against other potential checkpoints Lag-3, Tigit and a whole bunch of other things. And there really are quite provocative data available now already in those settings. We're hopeful that we'll begin to tease out how best to use those things in combination. So, lots of exciting things going on here.

Next one is from David Risinger of Morgan Stanley. Go ahead, please.

David, are you on the line?

Sorry. Yes. Can you hear me now?

Yes.

Great. So, I have a few questions. First, could you provide an update on where GARDASIL manufacturing supply stands and the GARDASIL revenue growth prospects in 2020? And then, Roger, could you discuss potential proof of concept results for Merck's early to mid stage pipeline to watch in 2020? And in addition, could you provide a framework for the timeline for the second pneumococcal vaccine that Merck is developing for infants, which would be added to V114 to offer broader coverage longer term? Thank you.

Great. I think, the first question is on GARDASIL supply and outlook. So, Frank?

Yes, Dave. So, with regard to GARDASIL, we do continue to see very strong demand around the world. Currently, our supply is not able to meet that demand. As we mentioned, we saw a growth of 21% this year. The growth we do believe will continue in 2020 will be slightly tempered from the rates you've seen in 2019 and 2018. And we're focused with our manufacturing colleagues to do everything we can with contract manufacturers in the near-term to try to help our supply. And then ultimately in 2023, as we've been mentioning, we'll be bringing on two new bulk manufacturing facilities that will really allow us to ramp our supply up to meet the strong demand that we're seeing globally.

Roger?

David, on the early to mid stage pipeline, well, we've already discussed that in a lot of programs in oncology in combination with KEYTRUDA, but we have a lot of other areas as well that are moving forward. Of course, building on the results of vericiguat in heart failure, the Phase 3 data which will be presented in the results for the near future and which are quite interesting. We actually have a lot of other interesting things going on in soluble guanylate cyclase activators. So, that's an important area for us and something that we expect to see quite a lot of data on. And we're going to be seeing a lot of data on of course our vaccine programs that I mentioned just a few minutes ago. So, there will be a lot of data coming forward in 2020. And speaking of vaccines, you mentioned the additional vaccine program. I think, you were referring to V117 in the pediatric context, which is not an add-on, but a separate and independent vaccine, all by itself. And that program, which we’ve just given the name to, will be moving forward shortly. I’d reemphasize that the V11 core program is very far advanced with lots of Phase 3 data coming forward this year and next year and will be a leading program in both adult and pediatric settings, ultimately V116 and V117 will provide further coverage. So, more to discuss there.

Next one is from Terence Flynn of Goldman Sachs. Go ahead, please.

Just maybe a couple on the spin as well. Does this change at all how you approach M&A and business development from a timing perspective? Just wondering, if we shouldn't expect any sizable bolt-ons until after the spin's completed. And then, are there any tax rate implications that we need to consider? And then, any update on the path forward for KEYTRUDA in neoadjuvant breast cancer regarding discussions with FDA? And then, when can we expect your Phase 3 frontline data in metastatic triple-negative breast. And is that important in terms of the conversations with the regulators? Thank you.

Okay. I think, we'll start with Ken and the timing of BD and our strategy around that.

I expect to see no change in our approach to BD from a timing or strategy standpoint, as a result of the spin. We still see the need to augment our pipeline going forward, and we see opportunities and we're going to be very focused on that.

Yes. And I would add to that point, and then I'll address the tax question. As I said in the prepared remarks, but it's worth reemphasizing, we will have ample capital to do anything we want to do. So, this also in a way constraints us from a capital perspective. But, with regards to the tax rate, generally speaking, you should not see any meaningful change to our tax rate as a result of this transaction.

Right. And Terence, with respect to neoadjuvant breast cancer, triple-negative breast cancer, of course the 522 data we presented at ESMO, the effective neoadjuvant in that setting, in terms of pathologic complete response is very clear. And we also had very provocative event-free survival data that we discussed. There is more data that will be coming forward in that. And we continue to have conversations with regulatory agencies about that study. And you're right, as we have an ongoing Phase 3 study in triple-negative breast cancer 355 that could yield data in principal, that would have an impact on thinking with regard to the neoadjuvant study, but of course we have to wait to see the data. So, that should be coming forward sometime relatively soon as well. It's event-driven, of course. I don't know exactly when.

Great. We're going to squeeze in one last question please, Carlo.

Last one is Mara Goldstein from Mizuho. Go ahead, please.

Great. Thanks very much. Just a quick question on NewCo spin-off and the targets around achieving an R&D organization and how should we think about that from a metric perspective? And then, just quickly on China, I know we've covered it, but Merck has spoken to China as a component of growth strategy on a go-forward basis. And understanding that KEYTRUDA has been a part of that but Merck has other portfolio of products in China, so I'm wondering how much of NewCo's business is responsible for the growth in that region and how RemainCo will be able to advance its growth initiative in the absence of NRDL listing, which didn't occur as expected?

So, the first question I believe was on R&D metrics around NewCo. Rob or Kevin, I don't think we have much to add there at this point.

No. And clearly, I would just say that as we think about the 35% operating margin growing over time that contemplates investments in research and development in the business. And so, it is fully covered. There is an assumption that they will be doing R&D moving forward. And we feel like it's been adequately covered in a way we resource the investments in the business. And, I don’t if Kevin wanted to add anything about the R&D other than what he said earlier.

I think just to recap what we said earlier that over time we'll build more of the research and development capabilities as we start to do meaningful business development and start to see opportunities to start to do development.

Great. And the second question?

China growth.

China growth. Yes.

This is Frank. With China, as we’ve discussed, we're very pleased with the growth this year of 58%. And our growth, to your point, is very broad based, it's KEYTRUDA, it's GARDASIL, it's Lynparza, it's Lenvima, it's our innovative portfolio has done very well, Januvia is on the NRDL, Zepatier, Zepatier was recently placed on the NRDL. So, we see our growth going forward in China and we see significant opportunities. Obviously, as I mentioned, we're all thinking about the coronavirus, we'll have to see how that unfolds, but nothing has changed in the mid to long-term about our opportunities in China.

Thank you all for joining us today. As I said in our third quarter call, we are confident but we're not complacent, and this separation is evidence of just that. We are convinced that the decision is the right one for the business and we believe that now is the right time to capitalize on a position of strength to secure even stronger future for Merck. As a more focused research-intensive biopharmaceutical company, we'll be better positioned to carry out our mission of inventing to save and improve lives and drive lasting value for the patients and shareholders we exist to serve. Thank you very much.

Thank you all.

Thank you. This concludes today's conference call. Thank you all for attending. You may now disconnect.