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Jyala
Conference Operator
Good morning. My name is Jyala and I will be your conference operator today. At this time I'd like to welcome everyone to Merck's first quarter 2019 Sales and Earnance Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks there will be a question and answer session. If you would like to ask a question during this time simply press star then the number one on your telephone keypad. To withdraw your question press the pound key. Thank you. I'd now like to turn the call over to Terri Loxum, FCP Investor Relations and Global Communications. Please go ahead.
Terri Loxum
FCP Investor Relations and Global Communications
Thank you, darling. Good morning, everyone. Welcome to Merck's first quarter 2019 Conference Call. Today I'm joined by Ken Frazier, our Chairman and Chief Executive Officer, Rob Davis, our Chief Financial Officer, and Dr. Roger Perlmutter, President of Merck Research Labs, who will each have prepared remarks. In addition, I'm also joined by Mike Nowley, our Chief Marketing Officer, and Frank Clyburn, our Chief Commercial 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 have excluded these from our non-GAAP results and provide a reconciliation of these 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 would like to remind you that some of the statements that we made 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 the 2018 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. You can see our SEC filings as well as today's earnings released on Merck.com. Finally, similar to last quarter, we have posted a presentation to the investor section of Merck.com, which includes some of our highlights from the quarter. With that, I'd like to turn the call over to Ken.
Ken Frazier
Chairman and Chief Executive Officer
Thank you, Terri. Good morning and thank you all for joining us today. We had a very strong start to 2019 and we are seeing our fundamental strategy of investing thoughtfully in R&D and following the science payoff. Our current portfolio of assets continues to drive strong growth and we are working to ensure that we capture the near-term opportunities in front of us to maintain this momentum while planning for the next generation of treatments. Our first quarter performance with double-digit -over-year sales and EPS growth are the results of portfolio and operational strength driven by oncology, vaccines, and select hospital and specialty products. We are confident that products within these areas, including Ketruda, Limpriva, Lendema, Gardasil, Brideon, and others, together with our animal health franchise, will lead to strong growth over the coming years. Our performance in the first quarter also speaks to our success globally as we've received a number of additional approvals and launched new products in various markets around the world. Our international business, which represented nearly 60% of our sales this quarter, has strong momentum and we believe that we've only scratched the surface in terms of the opportunity in key markets, such as China, where we are seeing significant growth. We foresee a stream of additional approvals from our current portfolio products across markets globally, and we will look to maximize these opportunities powered by our commercial teams' proven ability to execute. In parallel, we are also focused on advancing our promising pipeline and continuing to augment our internal research and development efforts with external innovation. We are excited by the prospects of our pipeline, which include potential new treatments and vaccines on coliseum, HIV, and many other areas of significant and ongoing unmet needs. There is also impressive work underway at our discovery hubs in Cambridge, London, and South San Francisco, where we're incorporating some of the most scientifically advanced modalities and technologies in the world. Importantly, these hubs are located where many of the best biotech and scientific minds are gathered, and we're benefiting from the vibrant academic and biotech communities in each of our respective hubs. Finally, we're continuing to evolve in a rapidly changing industry environment to best position work for sustainable, profitable growth over the long term, while helping to drive positive outcomes for patients. The overall healthcare landscape remains dynamic as the industry grapples with complex issues, such as the rising cost of healthcare generally, pharmaceutical pricing and access, and the shift to more outcomes-based reimbursement systems. At the same time, we believe that demand for even better outcomes for more innovative medicines will continue around the world, given the vast and growing unmet need in cancer, Alzheimer's disease, and in so many other areas as the global population continues to grow, while countries, certain countries, age. As a result, we will remain steadfast in going where the science leads us in order to bring forward transformative medicines and vaccines. We are confident in our strategy, our growth prospects, and our ability to continue to deliver significant benefits for patients and value to shareholders in 2019 and beyond. We look forward to discussing these matters in more detail with you at our Investor Day in June, where we plan to give you a deeper understanding of our pipeline and company, and provide you with the opportunity to meet a broader spread of our scientists and business leaders. With that, I'll pass the call over to Rob to go through the details of our quarterly results. Rob?
Rob Davis
Chief Financial Officer
Thanks, Ken, and good morning, everyone. As Ken mentioned, Merck had one of its strongest quarters in recent history. Our first quarter results reflect broad-based strength across our portfolio and continued discipline in our resource allocation. We executed very well across our key growth pillars, and our updated guidance reflects confidence that we remain well-positioned to deliver strong growth this year and into the future. Turning to the top line, total company revenues were $10.8 billion, an increase of 8% year over year, for 11% excluding the negative impact from foreign currency. This quarter was led by our human health business, with growth of 12% excluding exchange. Animal health revenues grew 3% excluding exchange. The remainder of my comments pertaining to sales will be on an ex-exchange basis. The increase in human health revenues was led by key products in our oncology, vaccines, and hospital and specialty businesses. Growth was strong in both the US and international markets, and especially in China, where sales increased 67%, year over year, driven largely by newly launched products. In oncology, Catrutas sales were nearly $2.3 billion this quarter, an increase of 60% versus the first quarter of 2018. Growth was primarily driven by higher use and first-line non-small cell lung cancer, both as monotherapy and with the rollout of the chemo combo. In addition, utilization remains strong across the breadth of indications, including melanoma, head and neck, bladder, and MSI-high cancers. With our recent approvals in adjuvant melanoma and renal cell carcinoma in the United States, we are now approved in 18 indications across 11 different tumor types, plus a pan tumor approval in MSI-high patients. We are also very excited by recent approvals in Japan and China, and look forward to making additional indications available to patients in markets around the world. In the US, first-line lung cancer remains a key driver of growth, given further penetration of the chemo combo in both non-squamous and squamous non-small cell lung cancer. We also are encouraged by early feedback in adjuvant melanoma, which was our first approval in the adjuvant setting. First-line lung has also become a larger contributor in ex-US markets, with growth driven by further uptake of our monotherapy indications in PDL-1 high expressors, but also by the ramp of the chemo combo, following regulatory and reimbursement approvals in select EU markets in Japan. In Europe, the uptake of the chemo combo in non-squamous patients is strong in markets where we have gained reimbursement, and we look forward to potential additional reimbursement approvals later this year, as well as the introduction of the chemo combo in the squamous setting. In Japan, the true to growth accelerated this quarter, given the recent approvals across five indications, including lung, adjuvant melanoma, and MSI high cancers, with utilization of the chemo combo in first-line lung cancer as a particularly strong driver of growth. Finally, in China, we are seeing strong sales of Catruta, following our launch late last year in metastatic melanoma, and we are very excited by our recent approval in China in first-line lung cancer. Overall, we remain very confident in Catruta's benefit to patients and long-term growth potential, given its established immunolungology leadership and increased utilization across many indications, and in markets around the world, as well as our expectation for many additional approvals going forward. We also remain encouraged by the progress and potential of both Limparsa and Lenvima, which we are developing and marketing in collaboration with AstraZeneca and eSci, respectively. Limparsa sales doubled this quarter, driven by further uptake in ovarian cancer following the U.S. approval of Solo I in December, as well as uptake in new markets such as China and Japan. In the U.S., across all tumors, Limparsa continues to lead the PARP-inhibitor class with over 50% total patient share. We remain excited by the long-term potential of Limparsa, especially with the recent start of the initial Phase III Catruta combination studies. Lenvima is another important product for our oncology portfolio. Sales this quarter reflected continued strong performance in hepatocellular carcinoma, following recent launches around the world. The launch in China is still early, but we believe the opportunity there is large, given the high prevalence of HCC in that market. Now, turning to vaccines. Our vaccines business reflected strong demand for Gardasil, which achieved sales of over $800 million this quarter, representing growth of 31% compared to Q1 of 2018. -U.S. demand remains particularly robust with continued strong uptake in China, following the Gardasil 9 launch last May and increased general neutral vaccination in Europe. The decline in the U.S. reflects timing of public sector purchases, which were more than offset underlying demand. The strong growth demonstrating across our overall vaccines portfolio was also helped by the performance of certain pediatric products. Our hospital and specialty business was led by 30% growth in sales of Brideon. U.S. growth reflects Brideon's increased utilization in procedures where a neuromuscular reversal agent is used, including in robotic and minimally invasive surgeries. Animal health revenue increased 3% this quarter to just over $1 billion. Compaining animal sales grew 6%, primarily driven by strong demand globally for the Brevecto line of products. Livestock sales grew 1%, driven by volume growth, particularly from new poultry and swine vaccines. This was largely offset by lower rumen and product sales driven by distributor purchasing patterns and weather-related softness resulting in delayed movement of cattle into the feedlots in the United States. While animal health growth this quarter was light versus recent trends, we still expect our four-year performance to again outpace the overall market. Additionally, we are very excited by the recent closing of our acquisition of Antelic, which establishes Merck as a leader in animal identification and monitoring, one of the fastest growing parts of the animal health industry. Turning to the rest of our P&L, my comments will be on a non-GAAP basis. Gross margin was .9% in the quarter, an increase of 30 basis points versus the first quarter of 2018. Favorable benefits of product mixed in foreign currency were mostly offset by lower price, higher royalties, and amortization of milestone payments. Operating expenses of $4.4 billion increased 2% year over year, including a favorable 2% point impact from foreign exchange. Our investments in research and development grew 9%, driven by clinical development spending in oncology and vaccines, as well as our discovery and early development efforts. SG&A spending declined 3% year over year, as we continue to drive productivity and reallocate resources to our highest value growth opportunities. Other income and expense reflected $21 million of expense this quarter versus $259 million of income last year. The negative variance was primarily due to a litigation settlement gain in last year's first quarter, as well as lower income from certain investments in equity securities and higher net interest expense this year. Our tax rate of .5% for the quarter was 350 basis points lower year over year, largely due to favorable discrete items, primarily related to foreign tax credits and prior year mix of income adjustments booked this quarter. Taken together, our earnings per share increased 18%, excluding exchange to $1.22. Turning to our outlook for the year, we are narrowing and raising both our revenue and non-GAAP EPS guidance ranges for 2019, reflecting our strong and continued operational performance. We remain confident in both our near and long-term prospects for revenue growth, driven by expected demand for innovative products across key growth pillars, which more than overcome expected headwinds from price foreign currency and pressures on mature and LOE products. For 2019, we now expect revenues of $43.9 billion to $45.1 billion, which represents 4% to 7% growth versus 2018, driven by strength across our oncology, vaccines, hospital and specialty and animal health businesses. This range assumes a negative impact from foreign exchange of just over one percentage point using mid-April rates, which is slightly above our former assumption. We are also increasing our expected EPS range to be between $4.67 and $4.79, including a slightly positive impact from foreign exchange at mid-April rates, down from the one percentage point positive impact we had previously assumed. The new range represents growth of approximately 8% to 10% versus 2018. Other elements of our guidance remain unchanged, including our expectation for roughly flat gross margins, a low to mid single digit increase in operating expense, driven mostly by the meaningful investments we continue to make in R&D, which we expect to increase in the back after the year, an expectation for roughly $0 in other income and expense, and finally a four year tax rate of a range of 18.5 to 19.5%. In summary, we are very pleased by our first quarter performance. We expect our operational momentum to continue throughout the remainder of 2019 with continued strength across our key pillars of growth. Strong revenue growth, along with disciplined resource allocation, will allow us to make important investments in our pipeline while at the same time delivering a leveraged P&L and meaningful increases in earnings per share. We believe our ongoing efforts to develop and deliver innovative products that help meet unmet medical needs for patients worldwide and coupled with strong commercial execution and disciplined financial management position us very well to generate strong, short and long-term value to society and to our shareholders. With that, I'd like to turn the call over to Roger. Thanks, Rob.
Dr. Roger Perlmutter
President of Merck Research Labs
The first quarter saw continued progress across all aspects of the R&D portfolio. As has already been mentioned, early in the quarter we obtained US approval for Key Cruda when used as adjuvant therapy in the treatment of patients with malignant melanoma with lymph node involvement following definitive resection. More recently, we obtained approval for combined use of Key Cruda and Pfizer's X-Tintinib in the first line treatment of advanced renal cell carcinoma based on the results of our Keynote 426 trial. The strength of this study in which improved overall response rates, progression pre-survival and overall survival compared with traditional treatment with single-agency nitinib were observed led to a very rapid review with approval secured nearly two months prior to the PDUFA date. I should also note that the combination of Key Cruda plus X-Tintinib yielded consistently favorable results versus significant in all traditionally defined patients subgroups and irrespective of PDL-1 expression in the tumor. Key Cruda acts on a very broad range of malignancies. The current FDA label includes indications from salvage to ashen therapy applied in different settings and spanning 11 different tumor types with more indications currently under review. During the quarter, we also gained approval for Key Cruda in China when combined with platinum plus tematrexate chemotherapy in the first line treatment of non-small cell lung cancer. With this approval, we hope to bring the benefits of this combination regimen previously approved in the United States, the EU, Japan and other major jurisdictions with a very large population of patients in China suffering from pulmonary malignancy. We also obtained FDA approval for the use of Key Cruda monotherapy in patients with non-small cell lung cancer whose tumors expressed PDL-1 on 1% or more of tumor cells based on the results of our keynote 042 study. This indication broadens the use of Key Cruda monotherapy to a much larger set of patients. Previously, only those patients in whom 50% or more of tumor cells were shown to express PDL-1 were included in the monotherapy indication. This recent broader approval also includes stage three patients who are not candidates for surgical resection of their disease or for treatment by definitive chemo radiation. At this point, I should note at the end of the first quarter, we posted our 1000th Key Cruda study on clinicaltrials.gov. Unsurprisingly, the bulk of new studies examined combinations of Key Cruda with other regimens and at earlier stages of disease. Not all of these studies yield the results that we and our patients around the world hope for. As we have previously announced, both our keynote 240 study in patients with avicellular carcinoma and our keynote 062 study in the first line treatment of patients with gastric cancer did not meet our expectations. However, both of these studies, the results of which we expect to be discussed at the American Society for Clinical Oncology meeting in June, provided important information that will assist specialists in refining their treatment regimens. In addition, the aggregated results of our clinical programs inform the selection of novel agents. As an example, we have more than 20 new molecular entities currently under study in the early stage clinical trials. Beyond this, together with our colleagues at AstraZeneca, we made significant progress in advancing the use of our PARP inhibitor, Linparza, for the maintenance treatment of patients with malignancies that bear evidence of defective DNA repair. Just yesterday, we announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, has adopted a positive opinion recommending Linparza as first-line maintenance treatment for women with advanced BRCA mutated epithelial or ovarian phylocine tube or primary peritoneal cancer who have responded to traditional first-line platinum-based chemotherapy. This recommendation, for an indication that has already been achieved in the United States, was based on the SOLA-1 study showing that Linparza treatment reduced the risk of disease progression or death by 70% versus that observed with placebo treatment. The CHMP recommendation follows approval by the European Commission authorizing Linparza for the treatment of germline BRCA mutated HER2-negative advanced breast cancer based on the Olympiad trial. Also, in the first quarter, we announced that Linparza treatment improved progression through survival versus placebo in patients with germline BRCA mutated metastatic pancreatic cancer whose disease had not progressed on platinum-based chemotherapy. Pancreatic cancer is an exceedingly difficult disease to treat, and we were gratified to see both statistically significant and clinically meaningful improvement in patients with germline BRCA mutations. On the infectious disease front, earlier this month, we had the opportunity to describe the use of Zirvaxir to treat hospital-acquired and ventilator-associated pneumonia at the European Congress on Clinical Microbiology and Infectious Disease Meeting in Amsterdam. In this ASPECT-NP study, we evaluated an increased dose of Zirvaxir, three grams per day, which provided improved intra-pulmonary drug levels and infected lungs. The study met its primary and key secondary endpoints in this critically ill population, 92% of whom were accessed in intensive care units, including favorable efficacy in patients with key gram-negative pathogens. The results of ASPECT-NP are currently under priority review at the FDA as a qualified infectious disease product for the poducadate of June 3rd. The same indication is also under review by the CHMP in Europe. Looking ahead and beyond Zirvaxir, we have multiple FDA poducadates during the second quarter. In the infectious disease area, the first quarter saw acceptance with priority review for our new drug application detailing the activity of our novel beta-lactamase inhibitor, Rellabactam, to be used in combination with Imipenem and Silastatin for the treatment of susceptible gram-negative infection with the poducadate of July 16th. In the oncology space, FDA has granted priority review for Keytruda in the first-line treatment of patients with recurrent or metastatic -nex-flamous cell cancer, either as monotherapy or in combination with chemotherapy, based on the results of the Keynote 048 trial with the poducadate of June 10th. And for Keytruda in the third-line treatment of patients with advanced small cell lung cancer, based on results from the Keynote 158 and Keynote 028 trials with the poducadate of June 17th. We're also looking forward to a large set of Phase III results, including the first data from our registration enabling program for the 15-valent pneumococcal conjugate vaccine V114, which is intended to provide broad protection against invasive pneumococcal disease in susceptible populations. We will provide more information about this program and about our other areas of research at the Investor Day meeting on June 20th. Now my colleagues and I will take your questions.
Terri Loxum
FCP Investor Relations and Global Communications
Thanks, Roger. Darla, we'll move to the Q&A portion. We're sensitive to the rest of our peers reporting this morning, so we'll end our call just before 9 a.m. So I'd ask that you keep your questions to a maximum of one or two, so that we can get as many people on the call as possible. So Darla?
Jyala
Conference Operator
Just as a reminder, to ask a question, simply press star, then the number one on your telephone keypad. And your first question is from Jackson Garberry, Bank of America.
Jackson Garberry
Analyst at Bank of America
Oh hey, good morning. Thanks for taking my questions. Just two for me. First, can you talk, Ken, maybe a little bit about the future of Merck's role as a primary care company? I know a lot of investors perceive the company is largely pivoting post-Ginuvia LOE away from primary care and becoming more of a specialty company, but you also have programs like MK7264. So just, if you can provide a little bit of color in terms of the company's commitment and thought process regarding being a primary care player longer term. And then just, secondly, can you guys give a little bit of color the Kachruidong opportunity in China? A little bit more specifics there would be helpful, thanks.
Ken Frazier
Chairman and Chief Executive Officer
Well, let me start by just saying that as a company, we are focused on following the science and coming up with innovative products that make a big difference. We are not saying we're going to be totally a specialty company or a vaccines company or a primary care company. What we actually wanna do is to make sure that we take advantage of the best opportunities. Right now, in oncology, the current growth is largely driven by that. But if you look at our pipeline, things like, for example, the pneumococcal vaccines are things that are essentially primary care type products. So I would say we haven't committed ourselves to one area of medicine. It has always been helpful to us to follow the science and we're gonna continue to do that going forward.
Frank Clyburn
Chief Commercial Officer
And with regards to China, good morning, this is Frank. We're one, very excited about the overall opportunity in China as we demonstrated, as Rob mentioned, 67% growth versus prior year. Specifically with Catruda, last year we received our second-line melanoma indication in China and as Roger mentioned, we just received our first-line lung indication with the combination with chemotherapy. We're really excited about the opportunity in China. We'll be working through the NRDL listing process with the Chinese regulators and given the timing of our lung approval, we'll have to see if NRDL listing is a possibility this year. A listing would open up an exciting opportunity to expand volumes, but even without that, we feel as though we're very well positioned with Catruda in China. We're the only PD-1 that has a first-line lung cancer indication and we feel as though the breadth of our program, as you've seen in other markets, we plan to bring additional indications to China which we think positions us very well for future growth.
Terri Loxum
FCP Investor Relations and Global Communications
Great, thanks. Let's move to the next question, please.
Jyala
Conference Operator
This is from Emma Raffat with Evercore ISI.
Emma Raffat
Analyst at Evercore ISI
Hi, thanks so much for taking my question. I actually wanted to focus not on cancer today for a change and perhaps on HIV for a minute. I just wanted to gauge your expectations into the drive to simplify a phase two trial coming up this summer. I understand you have a tripla-like regimen and I guess my question really is, what is it that we can learn about MK-8591 in the context of the combination pill and what are you specifically looking for on deciding whether to take this program forward into larger phase three? Thank you.
Dr. Roger Perlmutter
President of Merck Research Labs
All right, Amar. 8591 has extraordinary properties, as you appreciate. Both in terms of its potency and in terms of the duration of its effect. We've had the opportunity to present some of those data in the past, but we're now getting, we'll have a chance to look at significant phase two studies of long duration. I'm quite optimistic, actually, that we're going to see very good responses in that setting and that that will lead to phase three programs. Over time, I think the real advantage of 8591 is its ability to be put into a long-term format as potentially an implantable that could provide enormous benefits from a pre-exposure prophylaxis point of view, but as well dramatically simplify the treatment regimen for patients who are already infected with HIV in order to achieve long-term viral suppression. So we're going to be looking at those results, phase two results very soon and have the opportunity to present them, and I think that will lead to much larger studies. And we're quite enthusiastic about 8591.
Terri Loxum
FCP Investor Relations and Global Communications
Great, thank you. We'll move on to the next question, please, Carla.
Jyala
Conference Operator
This is from Krisha, WJP Morgan.
Krisha
Analyst at WJP Morgan
Great, thanks very much for the questions. I guess there's two here. Maybe first, can you just elaborate a little bit more on Keytruda in frontline lung, as we think about Europe? Where are we at this point in terms of reimbursement and market share, and how should we be thinking about kind of the ramp in that first line lung business as we go through the rest of this year? My second question was just trying to get a better handle along longer-term margin dynamics. Can you elaborate a little bit more on expense trends over time? I know specifically you've talked about R&D investments this year and next, but we think longer-term. Can we think about expenses actually rolling over beyond 2020 and science decline, or is the longer-term margin opportunity more about expenses just growing at a slower rate than top line? Thanks so much.
Frank Clyburn
Chief Commercial Officer
So, good morning. With regards to Keytruda outside the US and Europe in particular, first, we're very pleased. We sold close to $985 million this quarter and had growth of almost 69% versus prior year outside the US. So, we're very pleased with our progress. In lung specifically, lung represents about 70% of our sales outside the US. We have access right now in Germany and many of the mid-European markets. We're still working on access in several of the other large European markets for reimbursements, which we expect will come online hopefully in the second half of this year. So, our overall momentum where we have first-line lung approval for monotherapy is very strong with a leader clearly in lung. In that setting, the chemo combination has helped us to ramp, as I mentioned, and we have market-leading shares in the markets in Europe there, and then look forward to the second half of the year where we'll see additional reimbursement, additional markets come on board for access. So, we're very pleased with where we are in Europe and outside the US with regards to lung.
Terri Loxum
FCP Investor Relations and Global Communications
Okay, and Rob, please come
Rob Davis
Chief Financial Officer
to the margins. Good morning, Chris. So, with your question on margin, maybe just an overall comment on the specifics on what's happening in the operating expense line. We have said and we continue to believe we do expect meaningful operating margin expansion over time driven by revenue growth, the changing mix of our business, our continued focus on efficiencies, and ultimately a moderation of our R&D growth over time. So, I just put that out there to set context, but specifically when you look at what will be driving the margin expansion into your question, we will continue to see R&D grow over the next couple of years, and we would expect that to be at a rate faster than sales, but after that, we do expect to see R&D moderate. It will still grow, and our overall OPEX, we believe, will continue to grow. It just will be growing at rates lower than sales that should allow for the margin expansion we've been talking about. So, it's not that we expect absolute reduction in spend, we're just a moderation of growth as we move through the bolus of investments in the really expansive and frankly impressive clinical program that our MRL colleagues have put together in the near term here.
Terri Loxum
FCP Investor Relations and Global Communications
Okay, let's move on to the next
Rob Davis
Chief Financial Officer
question, please.
Jyala
Conference Operator
This is from Nevin Jackett, will you be here?
Nevin Jackett
Analyst at Canaccord Genuity
Hi, thanks for taking my question. If I may, on Keytruda, the administration will be, or the OMB will be putting out regulations on, or draft guidance on IPI. Just wondering to the extent that you can share with us what the average net price is in Europe relative to the net price here in the US. Is the administration's characterization of EU to US pricing differential of, or US to EU pricing differential of 1.3 to 1, is that fair? And then number two, just on the China market, how large is Keytruda right now, roughly annualizing at, in China, that'd be very helpful to us, thank you.
Frank Clyburn
Chief Commercial Officer
Yeah, so on the first question, this is Frank, with regards to Keytruda, we're really focused on our overall strong underlying demand in the US and outside the US and our strong data. We haven't shared with regards to net pricing outside the US. With regards to China, we see the opportunity as very significant. If you look at the lung market in particular, you know, there's 600 to 700,000 lung cancer patients in China, half of them have a driver mutation and we think a couple hundred thousand of those patients are available for treatment with our overall Keynote 189 regimen, so we see China as a very significant opportunity of growth going forward and we're very pleased that we're rolling out our new lung cancer indication.
Terri Loxum
FCP Investor Relations and Global Communications
Thanks, Frank. We'll move on to the next question, please, Carla.
Jyala
Conference Operator
This one's from Vamal Devan, with credit, please.
Vamal Devan
Analyst at Credit Suisse
Hi, great, thanks for taking my question. So one, maybe just on the lung side, you mentioned the Keynote 04-2 approval. Can you maybe just quantify your expectations on the use of monotherapy in patients with PD-L1 between one to 15 and also the stage three opportunity, I think, maybe caused some people by surprise with that label expansion, just so you can talk about the commercial opportunity there and then maybe Ken, just building on the earlier question around primary care and business development priorities, can you maybe just comment broader on the size of deals? I know you said you wanna sort of focus on the science, but I think a lot of investors are also curious on just as you think about both on versus larger transactions or any changes in your priorities there.
Terri Loxum
FCP Investor Relations and Global Communications
Thanks. All right, let's start with Frank.
Frank Clyburn
Chief Commercial Officer
Yeah, so Keynote 04-2, we see as a very positive advancement for our position in non-small cell lung cancer. As Roger mentioned, our new indication is based on, for patients who are not candidates for surgical resection or definitive chemo radiation. So it gives us an entree in the stage three patients. It's a smaller subset of stage three patients based on our indication, but an important indication for us to expand into non-small cell lung cancer. The other aspect that 42 does allow us, it allows for now all PD-L1 positive patients in the metastatic setting that would look for a monotherapy option. And there are patients that look for monotherapy options maybe based off of their performance status or other comorbidities. We see this as an important opportunity as well. So we're very pleased that Keynote 42 helps to round out our overall lung story and positions us very strong for future growth in lung.
Ken Frazier
Chairman and Chief Executive Officer
Okay, and on the business development side, I would just say that, first of all, last year we were very active. We did about 60 transactions spanning licensing, technology deals, and clinical collaborations. As we said before, our goal is to find the best scientific opportunities that we can. Our balance sheet gives us the opportunity to look across the entire spectrum of opportunities. But we've also been very clear that while we look at everything, what's most appetizing to us are the bolt-on deals because we believe they're the least disruptive thing from an R&D standpoint. I would also comment that while at the end of last year we felt valuations were going in the right direction, with the first quarter of 2019 market recovery, assets seemed more fully valued. And as we look forward, we continue to say we have to be disciplined and look for those opportunities where we can create value going forward. Thank you.
Terri Loxum
FCP Investor Relations and Global Communications
Thanks, Ken. We'll move on to the next question.
Jyala
Conference Operator
This is from Andrew Baum with Citigroup.
Andrew Baum
Analyst at Citigroup
Thank you. A couple of questions, please. The first one for Roger on V114. Simplistically, one could say, well, your competitor is in market experience. It has a greater number of serotypes. There is pressures for replacement strains and so on. I might underline the word simplistically. But what is it that you believe Merck brings to the table, apart from speed to market, which you think is gonna make sure that Merck is a major participant both in the pediatric and adult segments? And then second, in relation to the IPI proposals, and this is addressed to Ken or Frank, what do you think is the ultimate impact of IPI, given the ability to negotiate in Europe and provide non-transparent discounts, the increased list, as well as the complexity of a Texas pricing, the 340 B hospitals? How does that all shake out? And do you think it's actually feasible to find the solution that works?
Terri Loxum
FCP Investor Relations and Global Communications
Let's start with, thanks, Andrew. We'll start with Roger on V114.
Dr. Roger Perlmutter
President of Merck Research Labs
Right, Andrew, thanks. So first of all, we're not inexperienced in the pneumococcal disease market. And we have had Pneumovax on the market for decades. This is an area that we know extremely well. The pneumococcal conjugate vaccines have been in development for more than 20 years in our laboratories. In fact, I started these programs during my first tour of duty a long time ago. And so we've learned a great deal about how to make these vaccines and make them very efficacious. In particular, we've learned about balancing stereotypes in order to provide the broadest possible response. Over time, our program, which includes not just V114, but others as well, will become an important contributor to human health and to protection from pneumococcal disease, invasive pneumococcal disease, both in adults and in the pediatric population. So you'll see that evolve over a period of years. It's going to be an important contributor, no doubt.
Ken Frazier
Chairman and Chief Executive Officer
On the international price index situation, so we have, first of all, we submitted our comments. We continue to see that it's not the best approach to dealing with the major problem that we have with patient -of-pocket costs. We think we're much better approaching. I think it's still early days. I don't know exactly how these kinds of things will be implemented. There are a number of proposals out there, as you know, involving healthcare reform in this country. I would say that we negotiate as much as we can in ex-US markets for the value that we believe that we can bring. And I don't think anyone's supposition that by doing that, it's gonna improve our ability to negotiate in Europe is really the right thing. Finally, I would say that we've looked at some of the calculations in the report about Keytruda. We're not sure they're actually the right ones, but I will tell you this, that we continue to focus on the strong data that makes Keytruda a unique product across many indications.
Terri Loxum
FCP Investor Relations and Global Communications
Great, thanks Ken. We'll move on to the next question.
Jyala
Conference Operator
This one's from Steve Scalick with CalWin.
Steve Scalick
Analyst at CalWin
Thank you, a couple questions. Keytruda numbers were impressive, but a touch below expectations. Just wondering if there were any one-time factors that impacted the Q1 number. And secondly on Jeffapixin, it looks like an effective drug and a safe drug, but I don't believe the phase two data in OA or OA pain ever was presented. Neither were other smaller studies that completed some time ago. So can you elaborate on the data set of supporting Jeffapixin? Thank you.
Terri Loxum
FCP Investor Relations and Global Communications
Right, let's start with Brian from Keytruda.
Frank Clyburn
Chief Commercial Officer
Yeah, so Keytruda sales, as we've mentioned, were $2.3 billion this quarter, up 60% growth year over year X exchange. And what I tend to look at is what's happening from an underlying demand perspective. And when you look both versus prior year and sequentially, we're seeing very good continued underlying demand. You will see quarter to quarter some fluctuations based on some inventory movements. But overall, I think that we feel very good about how we're seeing the demand ramp. And in particular, we're seeing strong overall demand with regards to our lung cancer indications, both in non-squamous and squamous cell carcinoma, non-small cell lung cancer. In fact, in squamous cell lung cancer, we're seeing our market shares exceed 75% for new patients. So we've become the standard of care in that subset of patients. We also are feeling very excited about the opportunities outside of lung. In the U.S., as Roger mentioned, we have our new indication now based off of Keynote 426 in renal cell carcinoma. We see that as a very significant opportunity for future growth. As well as Roger also highlighted Keynote 48 with the PDUFA date coming up in June for head and neck cancer. And we have market leadership position in head and neck in later lines of therapy, and we're very excited about Keynote 48. In addition, the last thing I'll mention is outside the U.S., as we've been saying, we see significant opportunities based on some of the continued rollouts in Japan, in China, and in Europe. So we're very confident about the Katrina ramp and future growth prospects going forward.
Terri Loxum
FCP Investor Relations and Global Communications
Thanks, Frank. We'll move to Roger. Right,
Dr. Roger Perlmutter
President of Merck Research Labs
Steve. On 7264, Jeff, I think that the underlying logic of this is the belief based on a variety of preclinical studies that the pyranoid receptors and particularly P2X3 contribute to a neuronal hypersensitivity syndrome. So in the setting of chronic stimulation, there's sort of a feed-forward phenomenon, and it contributes to allodynia and other sensitivity syndrome. That's true, we believe, in the first case, in the chronic cough setting, where an early stimulus, usually the result of inflammation, leads to a cough syndrome that does not resolve after eight weeks. And in that setting, as we've demonstrated in phase two studies, Jeff, a fixed hand has traumatic effects, but as well in some other chronic stimulation syndromes. And we're looking at a number of those, including ischemia and isometriosis. We believe there's a lot of preclinical data that supports the conjecture, but fundamentally we need better clinical data, and that's what we're gonna get.
Terri Loxum
FCP Investor Relations and Global Communications
Thanks, Roger. We'll move on to the next question.
Jyala
Conference Operator
It's from Jeff Machen with Barclays.
Jeff Machen
Analyst at Barclays
Morning, guys. Thanks for the question. Frank, I wanted to ask about lung trends in the US. When I look at brand impact data, it shows first-line share that's stable at around 60% in one queue. So the question is, are you seeing any moderation in sequential share gains in the US, and what do you think the ceiling share could be in first-line lung? And in the recent immune design deal, Roger, can you talk maybe more broadly about how you can leverage a technology optimally, and now that it's in-house, and how do you guys view a new engine and approach in NIO more broadly? Thank you.
Terri Loxum
FCP Investor Relations and Global Communications
All right, let's start with Frank.
Frank Clyburn
Chief Commercial Officer
Jeff, in the US and lung, what we're seeing is with regards to share, you have to take out patients that do not have an EGFRL, genomic tumor aberration. So we see our market shares somewhere in the low 70% share for the non-squamous, non-small cell lung cancer segment. So we see very strong penetration, Jeff, within PDL-1 positive patients, the 50 and above segment, we're pretty much getting all of those patients, in the 1 to 49s, we have penetrated very significantly. We still have opportunity for growth in the PDL-1 negative patient population, and that's a focus for the commercial team. So I do see that as being the opportunity we'll continue to educate, in particular the community physicians in the US with regards to lung. As I mentioned, with regards to the squamous, non-small cell lung cancer patient population, we have penetrated that very rapidly, over three-quarters of those patients are now being treated with a chemo combo regimen or with monotherapy. So we still see growth for squamous, but clearly we have penetrated that segment very rapidly. And as I mentioned before, we're very excited not only about lung, but all of the other indications that I spoke about, and that Roger spoke about, that are upcoming new launches for us in the US.
Terri Loxum
FCP Investor Relations and Global Communications
Thanks, Frank. We'll move to Roger on immune design.
Dr. Roger Perlmutter
President of Merck Research Labs
Right, Jeff, thanks for the question. So in immune design, there are two principal assets and both of high interest to us. I mean, the first is a molecular-defined adjuvant, GLA adjuvant, which we believe could be beneficial for some of our newer vaccines that require adjuvant, and as well for some of the older vaccines where there's a desire to get to less, a fewer, a smaller number of vaccinations. So we're looking at those things very carefully. The adjuvant has been in thousands of people, and so we already understand its safety profile quite well. So that's good. And the second thing is the lentivirus vaccine, which is unique from several perspectives. The first is its selective targeting of dendritic cells. The second is its high carrying capacity. And the third is that it has already a substantial amount of clinical exposure demonstrating that it actually stimulates an immune response. That can be applied to neoantigens, but it can also be applied as they have to more conventional cancer testis antigens, which are often forgotten about, but I think may someday have their day in the sun. So we're looking forward to pursuing those kinds of approaches in combination with other immune modulators that we've already developed.
Terri Loxum
FCP Investor Relations and Global Communications
Thanks, Roger. We'll move
Lelish Chen
Analyst at Canaccord Genuity
on.
Jyala
Conference Operator
Your next question is from Lelish Chen with Cancer.
Lelish Chen
Analyst at Canaccord Genuity
Hi, thanks for taking my questions. So my first question is on China, and do you think that individual drugs have blockbuster potential, and if so, what has to change in the market for this to happen? And then just a follow up question on V114. If it's approved, what is your -to-market strategy in light of competition that's in the market now and potentially coming? For example, will you target children first and then go after adults? And then what do you anticipate the ACEF recommendation may be? Thank you.
Terri Loxum
FCP Investor Relations and Global Communications
We'll start with Bryce in China.
Frank Clyburn
Chief Commercial Officer
So with regards to China, we see China as a very significant opportunity for us. As we mentioned, we're seeing very strong growth. And I think for us, what's important is we have pivoted to innovation in China, and this has always been a part of our overall strategy at Merck. So when you think about the launches right now in China, Gardiso, of Catruda, Limparsa, Lymvema, Gordian, Genuvia has just now received NRDL listing. We see significant opportunity for China across a number of products within our innovative portfolio.
Terri Loxum
FCP Investor Relations and Global Communications
Great, thanks. Move over to Mike Nowley for V114 Outlook.
Mike Nowley
Hi, Louise. When you think about V114 and the opportunity going forward, we think there's a great opportunity in both the pediatric and adult segments. Obviously, we've had a presence in the adult segment, as Roger noted, with Pneumovac23 for over 35 years. And as we think about the pediatric segment, clearly we're touching all pediatric offices basically around the world with our existing vaccines. And so when we look at the opportunity for V114, a lot of it comes down to really understanding the underlying epidemiology and how that's evolving over time. With V114 at a market level, that is different, but also across pediatric and the adult segments, the epidemiology is evolving quickly. So as we think about the ultimate recommendations, it's clear that customers want choice in this market. And with V114, we think we provide a really valid alternative, especially given the fact that we have a very balanced immune response across all 15 serotypes that we're covering in our vaccine. And what we've seen to date is that there's some serotypes that are inadequately covered, and we're seeing breakthrough with those from the existing vaccines.
Terri Loxum
FCP Investor Relations and Global Communications
Thanks, Mike. We'll move on to the next question, please.
Jyala
Conference Operator
This is from David Reisinger with Morgan Stanley.
David Reisinger
Analyst at Morgan Stanley
Thanks very much. I have a couple questions, and if I repeated anything, for repeating anything, I apologize. First, with respect to animal health, the constant currency growth was 3%, including 1% in livestock. Was the issue in livestock just at the end of the quarter in the US, I think that there were the Midwest floods and other weather issues at the end of the quarter, but I don't know if there were other things that held back the livestock business. And I think that you said that for the full year, you expect growth to be greater than the market for animal health. What is the market expected to grow in 2019? And then separately, could you just quantify the inventory swings for Keytruda in the first quarter and for Gardasil, if there were any for Gardasil? Thank you.
Terri Loxum
FCP Investor Relations and Global Communications
Thanks, we'll start with Rob on animal health.
Rob Davis
Chief Financial Officer
Good morning, David. Thanks for the question. Yeah, as you look at what happened with animal health in the first quarter, your numbers you're quoting are correct and really what we were seeing is an impact of the cold weather. It's not necessarily the flooding that went through the middle part of the country, it's really more due to the cold weather patterns, which caused the cattle to stay in the fields longer and not move into the feedlots as quickly. And given that a lot of our products are more focused to the feedlots, that mixed dynamic of just how it played out affected us in the quarter. So that was part of it. We also then did see some buyout from our distributor partners due to some consolidation going on in the distributor space. So it was really a combination of a change in channel and buy down to pull down inventory in the channel and the seasonality impact that affected the business in the first quarter. As we look to the full year, we do expect to grow above market. And if you look at where the animal health market has been over the last couple of years, it's in the roughly, we'll say low to mid single digits of growth. So we expect to outpace that. And after the four, we layer in the impact of the Antelic acquisition.
Terri Loxum
FCP Investor Relations and Global Communications
We'll pass over to Frank or we click on inventory. Yeah, and
Frank Clyburn
Chief Commercial Officer
Dave, with regards to Catruda, as I mentioned, with the brand that is now of this size, you're gonna see some slight movements with regards to channel quarter to quarter. We're focused, as I mentioned, really on the strong underlying demand that we're seeing in our major indications as well as the future indications we're prepared to launch.
Terri Loxum
FCP Investor Relations and Global Communications
Great, let's move on to the next question,
Jyala
Conference Operator
please. This is from Alex Arshad with BMO Capital Markets.
Alex Arshad
Analyst at BMO Capital Markets
Oh, great, thank you very much. Frank, a follow up by May on the key to the opportunity in China, given that it sounds like it's going to become increasingly important. As I'm sure you know, there are Chinese companies that are also working on PD-1s, some of them moving to late stage. And these could compete with you on price. So as you look at China longer term, what's the outlook from a competitive perspective in the mean oncology? And do you also see a future where these PD-1s compete with key to the in the US and develop markets? And if I may, could you provide your estimated key to the sales by indications in major markets? Thank you.
Frank Clyburn
Chief Commercial Officer
Yeah, so let me start with the estimated sales in the US by indication. We usually provide that. 65% of our sales in the US are lung, 10% are approximately melanoma. Head and neck represents about 5%. And as I mentioned, we're very excited about the opportunity we have upcoming in head and neck. The latter represents about 5%. MSI high has become a very important indication for us, represents about 5%. And all others, approximately 10%. Going back to your question on China, we believe oncology is really a data driven area, Alex, given the severity of the disease. If you look right now, what's been accomplished with the truiden, we've always said that this wall of data is going to be important. And I think it's going to be very important for us in China as well. When you think about 18 indications across 11 different tumor types, we believe that this continues to differentiate us in the marketplace. China will clearly be a competitive market, but our first mover advantage with a first line lung cancer approval, we think sets us up very well. And the local players in China do not have an approved indication right now in first line lung, nor have they conducted or achieved the results of a trial like Keynote 189. So our strategy as we've seen in the US right now, there are five additional competitors there. And we believe our clinical execution and commercial execution and our significant amount of data will help us to compete in China as well as any other market around the world.
Terri Loxum
FCP Investor Relations and Global Communications
Great, we're gonna try to get at least one more in if we can squeeze it in.
Jyala
Conference Operator
It's from Tim Anderson with Wolf Research.
Tim Anderson
Analyst at Wolf Research
Thank you. Just a broader question on China in general, big growth in the quarter, but they've implemented certain policy changes like this four plus seven tendering process that a lot of industry participants think is going to slow down overall Chinese growth for multinationals. What is your outlook for that for Merck's overall book of business? And then second question is Keturda, the triple negative breast 522 adjuvant trial, just an update, are we likely going to see data this year? Is that still possible? And if it is, is that just gonna be PCR or could we actually see clinical efficacy being reported out? Thank you.
Terri Loxum
FCP Investor Relations and Global Communications
All right, so we'll do Frank from the quickly in China and then Roger on 522.
Frank Clyburn
Chief Commercial Officer
So to mention in China for us, we have pivoted to more of the innovative products that are driving our growth, Gardasil, Keturda, Berdian, Limporza, Limpina. So we feel that we're very well positioned and that's gonna help us to continue to see growth. We will likely see some impact from some of the older products based on some of the pricing initiatives that are underway in China and some of the provinces. So while we may see some bumpiness along the way, we have shifted the majority of our portfolio, approximately 60 to 70% of it is now is focused on innovative products. So we feel as though that positions us very well, not only in the near term, but for the long term growth in China.
Terri Loxum
FCP Investor Relations and Global Communications
You know, click on 522. On 522,
Dr. Roger Perlmutter
President of Merck Research Labs
yeah. Of course, the study is supervised by an external data monitoring committee and they will be evaluating it. It's event driven. My expectation is that it is possible for sure that we could see some review from them. There was a previous interim, which led to the study continuing and our expectation is that there will be an opportunity to see additional data, but I can't speak to what those data will be. And soon as we know, we'll have the opportunity to announce it. That's basically, they're under their control.
Ken Frazier
Chairman and Chief Executive Officer
So thank you for joining the call today. We are executing well across our business and we remain confident in our performance for the year in the long term. We look forward to discussing our pipeline and business in more detail at our Invest Today in June. Thank you.
Jyala
Conference Operator
This concludes March 1st quarter 2019 Sales and Earns Conference Call. You may now disconnect.
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