Merck & Company Inc (MRK)

“We're seeing very high interest from physicians and patients based on the approval announcement and ordering has begun last week, and we expect to be able to have it to pharmacies here shortly.”

“Third quarter sales will be impacted by the unwind of specialty pharmacy purchases in the second quarter.”

“We're excited about the opportunity. And as you know, in our MFN agreement, we did commit to putting LIPFENDRA on TrumpRx.”

“So as we sit here today, we feel that the LOE period is more of a hill than a cliff.”

“So we are expecting to see the pace not be as fast out of the gate, but with long term, continue to expect to see this to be definitely a blockbuster opportunity as we move forward.”

“What we have said all along is that we plan to launch in 2029.”

“I should emphasize that we do not have a cardiovascular outcomes trial right now, and we have an ongoing trial that will read out in 2029.”

“I do think you're going to see a shallow dip with a fast return back to growth.”

“Based on these results, we plan to advance ISL/ULO into Phase III studies for people living with HIV who are previously untreated and those with prior treatment experience.”

“We remain on track for potential approval in 2029.”

“We also continue to evaluate our monthly oral HIV prep option, alimatravir, in two Phase III studies anticipated to read out next year.”

“We are on pace for approximately $3 billion in share repurchases this year, as previously communicated.”

“We remain committed to the dividend with the goal of increasing it over time.”

“Finally, other revenue in the second half of 2026 is expected to be significantly higher than the second half of 2025.”

“For BRIDION, U.S. sales are anticipated to decline at a slower pace than previously expected due to lower-than-anticipated generic competition.”

“Next, we anticipate that total U.S. KEYTRUDA year-over-year growth will moderate as we increasingly reach peak penetration across several key indications.”

“We expect these actions to lead to accelerated growth in 2027.”

“Taken together, we expect EPS of $2.66 to $2.76 with a midpoint of $2.71, including a positive impact from foreign exchange of approximately $0.15 using mid-July rates.”

“We now expect a full year tax rate between 35% and 36%, which reflects the non-tax-deductible one-time charge for Terns.”

“Other expense, which now includes the financing costs for Terns, is expected to be approximately $1.4 billion.”

“Operating expenses are expected to be between $42 billion and $42.7 billion.”

“Gross margin is now assumed to be approximately 81%, reflecting higher inventory reserves.”

“We have raised and narrowed our full year revenue guidance range to be between $66.3 billion and $67.3 billion, representing growth of 2% to 4%, including a positive impact from foreign exchange of approximately 1 percentage point using mid-July rates.”

“Earlier this year, we provided insight into greater than $70 billion of commercial opportunity we have from over 20 new products that we expect will transform our portfolio and, in many cases, the practice of medicine as well as fuel growth well into the next decade.”

“We are hoping that with rosuvastatin, we would provide all the doses. But with that combination, we think that we could get up to 80%.”

“And candidly, if we look at it on a non-risk-adjusted basis, we still aspire to grow through it.”

“For KEYTRUDA, recall that while growth benefited from the timing of wholesaler purchases in the first quarter, we will face a corresponding headwind in the third quarter.”

“For ENFLONSIA, consistent with the first quarter, we expect minimal sales in the second quarter, given the seasonal nature of the product and continued high levels of RSV monoclonal antibody inventory in the market.”

“I would imagine that our estimation that we could get an approval at the second half of this year I see no reason to doubt that at this moment in time.”

“As the data evolved and we were looking at very specific patient-level data we believe that the MMR will be north of 50%.”

“We are on pace for approximately $3 billion of share repurchases this year, as previously communicated.”

“Lastly, we expect SG&A expenses to increase over the remainder of the year as we invest to maximize the impact of our recent and upcoming launches.”

“We are actively engaging customers in advance of the RSV season and remain focused on educating health care professionals and parents on the importance of protecting infants from this potentially serious disease and expect shipments to increase in the second half of the year.”

“In addition, ongoing investment to advance TERN-701 and the assumed cost of financing will negatively impact EPS by approximately $0.12 this year.”

“We expect the transaction will result in a onetime charge that will increase research and development expense by approximately $5.8 billion or approximately $2.35 per share.”

“Taken together, we expect EPS of $5.04 to $5.16, including a positive impact from foreign exchange of approximately $0.10 using mid-April rates.”

“We assume a full year tax rate between 23.5% and 24.5%, which reflects the nontax deductible onetime charge for Cidara.”

“Other expense is expected to be approximately $1.3 billion.”

“Operating expenses are assumed to be between $36 billion and $36.8 billion.”

“Our gross margin assumption remains approximately 82%.”

“We now expect revenue to be between $65.8 billion and $67 billion, representing growth of 1% to 3%, including a positive impact from foreign exchange of approximately 1 percentage point using mid-April rates.”

“Consistent with our strategy to maximize OHTUVAYRE's strong potential, we are making investments to reach more patients and physicians, which we expect will accelerate growth in the second half of the year and beyond.”

“Looking ahead, we continue to expect a particularly robust period of Phase III data readouts from novel candidates over the next 18 months.”

“if you look at the $70 billion, we are going to derisk substantially all of that by the time we get to 2027.”

“we actually are giving guidance of growth in, I think, the 4% to 7% or roughly 5% to 8% range over time, which actually is pretty strong growth.”

“we expect our animal health business, which we expect to more than double out to the mid-2030s”

“As we think about the QLEX adoption, we continue to think we are going to see 30% to 40% adopted as you get out to 2028, and we will drive that as high as we can.”

“Our guidance assumes approximately $3 billion of share repurchases, and we remain committed to not having excess cash build on the balance sheet.”

“We also expect significantly lower sales of Ligevrio due to continued soft demand.”

“We expect to deliver growth in 2026 driven by increasing contributions from our new launches, as well as continued strength in oncology and animal health.”

“We assume approximately 2.48 billion shares outstanding.”

“We assume a full-year tax rate between 23.5% and 24.5%, which reflects the non-tax-deductible one-time charge for Sidera.”

“Other expense of approximately $1.3 billion includes financing costs for Sidera and Verona.”

“Our gross margin assumption is approximately 82%.”

“For planning purposes, we continue to assume 2028 because I think that is a conservative assumption.”

“We do not think that a transformative acquisition, a synergy-driven deal is something that we need to do nor aligns with our future”

“I believe that we will be putting out a top line once we know it as well.”

“we also expect the headwind of IRA price setting on the JANUVIA family and the generic entrant for JANUVIA midway through next year.”

“We expect that to be utilized during the fourth quarter.”

“We are maintaining our increased pace of share repurchases and expect approximately $5 billion for the full year.”

“For KEYTRUDA, as previously communicated, year-over-year growth in the U.S. in the fourth quarter is expected to be negatively impacted by approximately $200 million due to the timing of wholesaler purchases.”

“Relative to 2024, this range includes a negative impact from foreign exchange of approximately $0.15, using mid-October rates.”

“Taken together, our EPS guidance is $8.93 to $8.98.”

“We assume approximately 2.51 billion shares outstanding.”

“We now assume a full year tax rate between 14% and 15%.”

“Other expense is now expected to be between $400 million and $500 million.”

“Operating expenses are now assumed to be between $25.9 billion and $26.4 billion.”

“Our gross margin assumption remains approximately 82%, including an updated estimate of less than $100 million in costs related to the impact of tariffs.”

“This range represents growth of 1% to 2%, excluding a negative impact from foreign exchange of approximately 0.5% using mid-October rates.”

“We expect full year revenue to be between $64.5 billion and $65 billion.”

“as we think about deal size, we continue to be focused in that $1 billion to $15 billion range as the primary area.”

“Based on these data, we plan to initiate late-stage trials in 2026.”

“We continue to expect that we're going to achieve 30% to 40% patient adoption and that, that will take us out to 18 to 24 months to achieve that.”

“Overall, we expect modest growth for GARDASIL in the near term.”

“The other headwinds that we will face will be related to loss of exclusivity and generic entrants. And that really is DIFICID that's seen generic entrant halfway through 2025 in the U.S., BRIDION, which will have its LOE partway through 2026.”

“And we do expect continued growth in KEYTRUDA, albeit at a slightly slower pace than we've seen as we are getting to peak penetration in some of the indications, and we do expect some headwind from price in our ex-U.S. markets.”

“WELIREG, has strong growth with greater potential ahead of it as we get into other successful studies and treat a broader range of patients.”

“We also have the expectation of continued growth in oncology.”

“So we're expecting continued patient impact and revenue growth from WINREVAIR.”

“So as we go into 2026, we are expecting solid top line growth for our company, and that growth will increasingly be fueled by the number of new launches that we have.”

“We have not given specific targets, but we see it growing as a percent overall of total sales, and it's over half of our growth.”

“We have initiated more than 15 Phase III trials this year and expect to have an increasing number in 2026.”

“as we look to 2026, we expect an acceleration in underlying operating expense growth driven by investments in both R&D and SG&A to fuel our pipeline and new launches, including more than $0.5 billion of investment to maximize the potential of OHTUVAYRE.”

“And when you exclude the impact of the headwind of China's GARDASIL, we have underlying growth of between 6% and 8%.”

“All of that said, we are confident in our ability to drive growth in our business this year of between 1% and 2%.”

“We remain confident in the outlook for our launch products and continued growth across oncology and Animal Health as well as our return to growth in the second half of the year.”

“We expect to return to growth in the second half of 2025 and remain confident in our outlook for the remainder of the year.”

“But what I would tell you is as we look at -- and I don't want to give '26 guidance because we're not giving forward guidance. But as you look at '25, I would tell you, if this was implemented immediately, it would be minimal impact based on all the work we've done around inventory management and moving our manufacturing to the U.S.”

“In relationship to the Hansoh GLP-1, we said that moving to clinic this year and everything is on schedule.”

“As we've been pretty consistently adding 400 to 500 patients per month. So I wouldn't read that the 1,600 in the quarter relative to some shift. It has been actually pretty steady, and we do continue to expect to see that kind of steady growth going forward as we move through the rest of the year.”

“We're not counting on it for growth. We are counting on our new products, the excellent execution we have in our existing products to drive growth for our company in the second half of this year and into the future.”

“As we look at our opportunities for GARDASIL, we do expect growth in 2025 and beyond, but that does not contemplate any change in the dosing schedule for the United States.”

“The other half is Europe and Japan. And we expect -- we, I think, recently got approval in Japan. So that's coming in the back half of the year, and then we expect broader reimbursement through Europe.”

“But as we look forward, we do continue to see a strong opportunity for growth.”

“We expect to maintain a similar level of repurchases in each of the third and fourth quarters of 2025, given our strong balance sheet.”

“Finally, we expect operating expenses to be roughly evenly split between the third and fourth quarters, excluding business development expenses.”

“While we actively manage the impact from foreign exchange through our revenue hedging program, based on mid-July rates, we expect to see a negative impact from our hedges, which is reflected in other revenue.”

“Next, we expect other revenue to be significantly lower in the second half of the year.”

“Overall, we expect full year growth for GARDASIL, excluding China.”

“As we look to the balance of the year for GARDASIL, Japan will be a more significant headwind to growth in the second half of the year as we lap the increase in vaccinations from the catch-up cohort in 2024.”

“In China, GARDASIL channel inventories remain elevated and demand continues to be soft. As a result, we will not resume shipments to China through at least the end of this year.”

“This range includes a negative impact from foreign exchange of approximately $0.15 using mid-July rates.”

“Other expense is expected to be between $300 million and $400 million.”

“Operating expenses are now assumed to be between $25.6 billion and $26.4 billion.”

“Our guidance of $200 million of costs related to the impact of tariffs is unchanged, pending the outcome of additional potential government actions.”

“Our gross margin assumption remains approximately 82%.”

“This range represents growth of 1% to 2%, excluding a negative impact from foreign exchange of approximately 0.5% using mid-July rates.”

“This business is going to be a fast-growing business for this company throughout our long-range plan period and is really based on a new product story very much like the Human Health business.”

“So you're going to see other oncology grow spend as KEYTRUDA is pulled back.”

“That said, we will reinvest all of that $3 billion plus further investments, especially in R&D, given the strength of our pipeline as well as in SG&A over time as we launch the new products and look to excel in the marketplace with those launches in order to drive long-term growth for our company.”

“I feel very good that as we sit here today with as I mentioned, the fact that we have, basically on-hand inventory in The United States to protect us through all of 2025.”

“So as you look at 2025, we're well-positioned with inventory to be able to mitigate anything we could see in the short term.”

“As we look forward, we remain confident in our outlook for improved growth in the second half of the year.”

“All of that said, we do expect strong growth excluding China, strong double-digit we've achieved in the first quarter and we expect continued strong growth as we go through the remainder of the year.”

“However, expect given the current dynamics in China, that is it is not so likely that we will ship further products in China, and that is actually an outcome that is incorporated into the midpoint of our guidance.”

“We are not using and do not really see price at the lever. For tariffs.”

“The PDUFA date is June 23.”

“The FDA has set up PDUFA date of September 23 and the European Medicines Agency is reviewing the application.”

“the phase two CADANCE study exploring the potential in pulmonary hypertension due to left heart disease a specific segment within WHO group two, has completed recruitment and is on track for completion later this year.”

“We expect the pace of repurchase to continue at this level given our strong balance sheet.”

“As a result, we expect higher net sales for these products in 2025.”

“As a result, global Gardasil growth excluding China while still strong, is anticipated to slow going forward.”

“Following the successful HPV catch-up vaccination program in Japan, we expect uptake to moderate as future sales will predominantly reflect the primary age cohort.”

“We assume approximately 2.51 billion shares outstanding.”

“Other expense is expected to be between $300 million and $400 million.”

“Our gross margin assumption is now approximately 82%.”

“With respect to potential additional tariffs by the US, specifically on pharmaceuticals, our global supply chain and current inventory levels put us in a good position to navigate potential near-term impacts.”

“Considering the current environment, we are maintaining our full-year revenue and EPS guidance excluding business development charges which Caroline will speak to in more detail.”

“As we sit here today, as we mentioned between the $12 billion we've done plus the $9 billion plus we have underway. So we're gonna be looking at, you know, north of $21 billion since 2018 as we look over the next few years. I actually think over time, you're gonna see that grow.”

“I expect, frankly, that number is gonna grow. Going forward.”

“And over the next few years, expect many of these programs to advance to Phase two and to become visible to you.”

“Wind rebar and CapVaxin represent the initial launches from this robust pipeline of 20 promising potential new growth drivers we expect to come to the market over the next few years almost all of which have blockbuster potential.”

“And as we look at 2025, we do actually see this as a strong growth contributor, and all of the fundamentals we see support that.”

“So, we'd expect a very immaterial impact from tariffs that were proposed over the weekend for those countries.”

“And it will still be in that zero to $15 billion range is our sweet spot, but obviously, open to looking at deals.”

“The lower list price will reduce the rebate amount Merck pays to Medicaid and as a result, we expect higher net sales for these products in 2025.”

“We expect Medicare Part D redesign to have a negative impact to sales of approximately $400 million, primarily affecting WINREVAIR and our portfolio of small molecule oncology products, including WELIREG, Lynparza, and Lenvima.”

“During the first half of the year, we expect roughly flat year-over-year revenues as the headwind in China is offset by high single digit growth across the rest of our business.”

“We assume approximately 2.53 billion shares outstanding.”

“We feel very good about that $25-plus billion number.”

“Our growth expectations outside of China for this important vaccine remain unchanged, and we are well-positioned to protect more lives and drive strong growth beyond 2025.”

“In fact, irrespective of the performance of GARDASIL in China, we expect the Company to deliver strong growth in the second half of this year, as well as in both 2026 and 2027.”

“We think if we can put the inventory situation behind us, we can get to a more normal market dynamic, one where with the underlying demand and the fact you have the male indication coming, it can come back to growth.”

“But we will not take our eye off the short term where we are equally confident in the guidance, we raised revenue today.”

“we tend to look in that $1 billion to $15 billion, is a good indication of where we would most likely play.”

“So because of the fact you're going to see increasing access, you're going to see the fact that we have increasing number of physicians, and we're continuing to see the breadth of patients grow, I think you're going to see continued trend for growth upward.”

“We are continuing to look at all global markets. And I would point out, as Dean points out, we're looking at the '25, '26 RSV season, so next year. And then beyond that, we will go globally thereafter.”

“Our plan is to file such that it would be available, not for this season, but for the next season within the United States.”

“the current contracted doses with Zhifei for 2025 are less than what the contract is for 2024 as we would expect to participate in that market but understand a competitor would likely gain share in that market.”

“We will continue to execute a modest level of share repurchases.”

“We remain committed to our dividend, and plan to increase it over time.”

“Given its compelling clinical profile, we expect that CAPVAXIVE will achieve a majority market share in the adult setting.”

“This range includes a negative impact from foreign exchange of more than $0.30, using mid-July rates.”

“Our gross margin assumption remains approximately 81%.”

“continue to believe we will achieve sales of over $11 billion by 2030.”

“As we look at it, we do expect you will see a flattening of the curve as we see the female indication, be more fully penetrated. Obviously, more to go there, given what we believe is still the addressable population. And then it will ramp back to growth as the male population comes on in full.”

“So Chris, in terms of our guidance, we've assumed a range of scenarios from providing the fully contracted 2024 doses during this year to providing something less than that.”

“we're confident in our ability to continue to drive growth during 2024. And in 2025, we will see our manufacturing capacity unconstrained so enabling us to further supply and support the market.”

“It's obviously early. But everything so far looks quite good. So our confidence in a successful launch has not changed. We continue to see this consistent with our expectations.”

“That D770, we will be sharing that data by early 2025.”

“The clinical trials are anticipated to start enrolling in the fourth quarter.”

“First-in-human studies are scheduled to start in the fourth quarter of this year.”

“WINREVAIR is currently being reviewed by the European Medicines Agency with a decision anticipated in the second half of this year.”

“We will continue to execute a modest level of share repurchases.”

“We remain committed to our dividend and plan to increase it over time.”

“So we continue to anticipate full year sales to be lower than last year.”

“This year, we expect more evenly distributed quarterly shipments to China.”

“Our full year tax rate is unchanged between 14.5% and 15.5%.”

“Our gross margin assumption is now expected to be approximately 81%.”

“We now expect revenue to be between $63.1 million and $64.3 billion, reflecting strong year-over-year revenue growth of 5% to 7%, including the negative impact from foreign exchange.”

“Obviously, if you look at then the size of the patient population where it could be, just to give you a sense, by 2028, if we look at the patients who are on monotherapy with KEYTRUDA who are using combinations with orals and those who are moving into earlier stages of disease through some of our adjuvant and neoadjuvant areas with KEYTRUDA, that represents about 50% of the patient population at that time.”

“We are hopeful that we will be announcing the opening of the Phase III and patients coming in for the Crohn's disease over the next few months.”

“And we remain very confident that V116 will both have a majority share and be a meaningful contributor.”

“As we go beyond 2024, we still point to an operating margin of greater than 43% in 2025.”

“As we look to 2024, we expect operating margin to improve.”

“So, we will price our subcu to drive for volume and to do for conversion, which means we will be looking at prices really more in line with where you would see the generic version at a premium that history has shown is very manageable and expected and covered by payers today when you look at the different delivery for them.”

“I think as you look in that zero to kind of $15 billion, $1 billion to $15 billion, it continues to be where we will look for.”

“For sotatercept, given the significant clinical data we have and the understanding that there are many patients that have already been identified who can benefit for sotatercept on top of the treatments they have, we are expecting a strong launch.”

“As a result of the increasing depth and breadth of our pipeline, we are planning to initiate an even greater number of Phase 3 trials in 2024.”

“We will continue to execute a modest level of share repurchases.”

“We remain committed to our dividend and plan to increase it over time.”

“In 2024, we will increase this investment, including the initiation of more late-stage clinical trials across multiple novel candidates, each of which has significant potential to address important unmet medical needs.”

“The headwind is primarily due to the devaluation of the Argentine peso, which we expect will largely be offset by inflation-related price increases, consistent with market practice.”

“We expect another year of strong growth driven by key marketed products and we will begin to benefit from the anticipated launches of impactful new products, such as sotatercept and V116.”

“I am pleased to share that we expect continued strong growth in 2024 driven by demand for our key products, which Caroline will speak to momentarily.”

“We are confident that we will close out 2023 with continued strong performance, which is reflected in the updated full year outlook that Caroline will speak to in a few minutes.”

“the demand for this will be quite high. So our expectation, as you will see a strong launch with this drug”

“So, altogether, we still do point to an operating margin of greater than 43% in the year 2025.”

“where we have noticed we expect about a $0.25 impact as a result of investing predominantly in the research and development of a wide range of programs”

“knowing that we have the royalty on global KEYTRUDA sales going from 6.5% to 2.5% at the start of next year and our royalty on GARDASIL going from 7% to zero percent on our global sales, again, at the start of next year will drive significant gross margin improvement.”

“as we look-forward, we expect continued margin expansion and that margin expansion really comes from the product mix on the revenue line, it also comes from the roll-off of royalties”

“We think this year we will have 20% of our KEYTRUDA business coming from the earlier stage cancer setting.”

“We remain committed to our dividend and plan to increase it over time.”

“This range includes a negative impact from foreign exchange of approximately 6 percentage points versus 2022 using mid-October rates.”

“Taken together, we expect EPS of $1.33 to $1.38.”

“We assume approximately 2.55 billion shares outstanding.”

“Our full year tax rate is expected to be between 39% and 40%, which includes an approximate 24.5-percentage-point impact related to our business development activity.”

“We now assume other expense of approximately $200 million, which reflects updated foreign exchange expectations given recent dollar strengthening and higher net interest expense related to Daiichi.”

“We now estimate operating expenses to be between $39.8 billion and $40.4 billion.”

“Our gross margin assumption is unchanged at approximately 77%.”

“We now expect revenue to be between $59.7 and $60.2 billion, an increase of approximately $900 million at the midpoint.”

“we look forward to the potential approval and launch in early 2024.”

“our confidence that we will achieve that $10 plus billion is higher today than it was when we made the original comment.”

“we have been commenting that we expect 50% of our growth to come from movement into the earlier stages of disease in oncology, as we look forward to ultimately get to a global percent with it being about 25% of our total revenues.”

“we hope to see those internal programs carrying its clinical head in the next couple of years.”

“So I'm quite confident we'll be prepared for our launch, both in the U.S. and outside the U.S.”

“As we look forward, we do see that those pricing headwinds sustain, but we are confident in the continued growth that we will drive for KEYTRUDA.”

“So I think you could expect a pretty fast uptake of the drug, especially in the United States.”

“I think given the general sense, we thought that we would be launching, at least within the U.S., in the earlier part of 2024.”

“If you look at lung cancer, we continue to expect growth. In fact, we're growing in lung cancer now, both internationally and in the U.S.”

“That will slow into next year in the U.S., but we're seeing it picking up outside the United States because we're at an earlier phase in the launch across the world.”

“That being said, we continue to have a priority to do business development. So you should not necessarily expect a slowdown.”

“That said, we continue to expect strong growth from KEYTRUDA given the current indications we have as well as new launches to come.”

“One of the distributors who has brought in has indicated that they expect to buy out in the third quarter. And the quantum of that buyout has been indicated to be $150 million.”

“As we think about the second half of the year though, we do expect shipments to China to be less than they were in the first half of the year and therefore expect the second half of the year growth to be slower than what we've achieved in the first half.”

“We continue to expect to execute a modest level of share repurchases this year.”

“And as a reminder, while we expect the pace of growth of GARDASIL to be higher in 2023 than 2022, the rate of second half growth is anticipated to be below the first half, due in part to the timing of shipments to China.”

“As we look out to 2024 and beyond, we continue to expect strong growth including the impact of additional approvals.”

“In addition, there was a small benefit from wholesaler purchase timing in the U.S. in the second quarter, which we expect to reverse in the third quarter.”

“We continue to expect strong year-over-year growth of KEYTRUDA, but not quite at the levels experienced in recent quarters, as a result of lapping launches and the impact of continued pricing headwinds, particularly as we launch new indications in key European markets.”

“We continue to assume approximately 2.55 billion shares outstanding.”

“Our full year tax rate is expected to be between 30.5% and 31.5%, reflecting an increase due to the Prometheus transaction of approximately 15 percentage points.”

“We now assume other expense of approximately $100 million, which includes incremental financing costs related to Prometheus.”

“Our gross margin assumption is unchanged at approximately 77%.”

“We're driving significant scientific, commercial and operational momentum which we expect will enable strong full-year growth.”

“What I do think is highly likely is that we will be able to see this resolved by the time we get into the 2026 time frame.”

“Finally, we are confident in our ability to drive strong growth of GARDASIL, particularly in international markets.”

“Taken together, we are increasing and narrowing our expected EPS range to $6.88 to $7.00.”

“I would not interpret that as implying a decline in GARDASIL in China over the coming years.”

“As we look at the subcutaneous formulation and where that can be utilized... Based on what we see, as we look out, we would expect about half of what we have as KEYTRUDA would be addressable through the subcutaneous route based on that definition of those areas.”

“We are initiating multiple Phase 3 studies including in secondary prevention; intermediate to high-risk primary prevention; and for patients with heterozygous familial hypercholesterolemia.”

“We are planning to initiate Phase 3 studies of MK-5684, a novel oral, nonsteroidal inhibitor of CYP-11A1, from our collaboration with Orion, by the end of this year.”

“Planning is underway for an expansive global clinical development program and we look forward to initiating Phase 3 trials for MK-2870, our TROP-2 targeting ADC, as both monotherapy and in combination with KEYTRUDA.”

“Merck and Moderna plan to initiate a Phase 3 study in adjuvant melanoma this year, and rapidly expand to additional tumor types, including non-small cell lung cancer.”

“We will continue to execute a modest level of share repurchases this year.”

“We remain committed to our dividend, and plan to increase it over time.”

“given the strong global demand for the vaccine, we see an acceleration of growth for GARDASIL in the full year 2023 relative to 2022, though not quite at the same level of growth achieved this quarter.”

“Outside the U.S., we continue to expect strong volume growth for KEYTRUDA; however, pricing is an increasing headwind, particularly as we launch new indications in key European markets, which will temper ex-U.S. growth.”

“While we continue to anticipate growth from these earlier stage indications, the year-over-year growth rate is expected to moderate as we anniversary their very strong initial uptake.”

“In addition, ongoing investment to advance the pipeline assets as well as the cost of financing will negatively impact EPS by approximately $0.25 in the first 12 months following close.”

“This range includes a negative impact from foreign exchange of approximately 4 percentage points, using mid-April rates.”

“We continue to assume a full year tax rate between 17% and 18% and approximately 2.55 billion shares outstanding.”

“Other income is anticipated to be approximately $250 million.”

“Our gross margin is still expected to be approximately 77%.”

“We expect strong underlying revenue growth of 8% to 10%, offset by the decline in LAGEVRIO and an approximate 2 percentage point negative impact from foreign exchange using mid-April rates.”

“In summary, we've begun 2023 with scientific, commercial and operational momentum and expect strong full year growth across both our Human and Animal Health businesses.”

“We see greater than $10 billion of opportunity from those assets in that same time frame.”

“On revenues, we are confident in our ability to drive strong growth of GARDASIL, particularly in international markets.”

“We begin the year with confidence that we will maintain this strong underlying growth, after taking into account the significant impact LAGEVRIO had during the height of the pandemic last year and are pleased to reflect this in our 2023 initial guidance.”

“For GARDASIL, we ... have two new facilities coming online over the course of 2023, 2024. So it will be a progressive ramp, but I will reiterate we are expecting an acceleration in our growth during 2023.”

“We will maintain an appropriate leverage for our company. We are very comfortable operating at the credit rating we are at and we would expect to sustain that kind of level as we go forward.”

“As you look at 2023, we expect the underlying impact of foreign exchange to be around 1 percentage point on the top and the bottomline.”

“There are some headwinds against that that we have talked about with LAGEVRIO with foreign exchange and with an increased level of pricing expected, especially in Europe with the changes we have seen in U.K. and also in Germany.”

“And we expect continued growth strong growth in our Animal Health business.”

“Vaccines, as you rightly note, driven by an acceleration expected in the growth of GARDASIL as we have new supply coming on line, as well as an acceleration in our VAXNEUVANCE performance, especially given the strong data we have for the pediatric setting.”

“It’s on -- we will be -- when we talk about starting 10 to 15 Phase 3 clinical trials, just in Oncology, this subcu program is a critical component to that and we will be starting those Phase 3 this year.”

“We plan to discuss the results with regulators and initiate Phase 3 trials in multiple tumors this year.”

“Given the strength of our business and balance sheet, we plan to resume share repurchases, while ensuring we maintain ample capacity to pursue additional business development, which is the higher priority.”

“This benefit is more than offset by an increase in the estimated tax rate due to the unfavorable impact of the R&D capitalization provision, as well as an approximate 1 percentage point impact related to Imago.”

“Other Revenue is projected to decline significantly, primarily reflecting a smaller planned benefit from revenue hedges following the U.S. dollar strength last year, which resulted in an approximate $800 million benefit in 2022.”

“Other Income is anticipated to be approximately $250 million.”

“Our gross margin is expected to be approximately 77%.”

“Finally, through our business development efforts, we brought in four programs which will have phase three trial starts in 2023 and which have the opportunity to contribute meaningful growth during the latter half of this decade and into the next.”

“KEYTRUDA and our expectation will lose exclusivity in the United States in 2028 and in China in 2028. It leaves it in Europe in 2030 and in Japan in 2032.”

“We are very confident that the 0.25 milligrams will be effective. We are confident that the effects on lymphocytes and CD4 T-cells will be comparable to any standard antiviral.”

“As we look at our opportunity to satisfy the global demand and protect as many lives as we can going forward, we will be supported by the increased supply and capacity that we have coming online commencing 2023. And we expect that, that additional supply will come online over the course of ‘23, ‘24 and ‘25.”

“We continue to demonstrate strong momentum and expect durable underlying demand across our key pillars, including KEYTRUDA, GARDASIL and Animal Health.”

“We have increased and narrowed our expected EPS range to $7.32 to $7.37, an increase of $0.05 at the midpoint.”

“We expect our full year tax rate to be approximately 14%.”

“We continue to assume other expense of approximately $500 million.”

“We are increasing and narrowing our operating expense projection to $21.3 billion to $21.7 billion, principally driven by a $250 million payment related to the recent exercise of our option to jointly develop a personalized cancer vaccine as part of our ongoing collaboration with Moderna.”

“We are maintaining our gross margin expectation of between 74% and 74.5%.”

“Excluding foreign exchange and LAGEVRIO, we expect growth of approximately 16%.”

“The projected impact from foreign exchange includes an incremental headwind of nearly 1% using mid-October rates, resulting in a full year negative impact of approximately 4%.”

“We now expect revenue to be between $58.5 billion and $59 billion, including LAGEVRIO sales of $5.2 billion to $5.4 billion.”

“We remain very confident in our ability to protect more lives, to drive growth long into the future, including doubling the revenue of GARDASIL in the year 2030 compared to where we were in 2021.”

“Should meaningful business development not materialize and depending on the pipeline of potential transactions, we will opportunistically buyback shares.”

“Overall, that guidance reflects our confidence that the strong underlying momentum of our business will continue into the second half of the year.”

“And so as we look at this, and you think of a relative to the guidance we've given in the past of expectations for strong growth through our long-range period. That continues and includes the assumptions around this.”

“Finally, to the extent we have extra cash, we will return it to shareholders through share repurchases.”

“We remain committed to our dividend, which we expect to increase through the time.”

“Finally, we continue to expect to look at full year sales of $5 billion to $5.5 billion, with second half sales weighted to the fourth quarter.”

“With respect to our products, for [indiscernible], we continue to expect a negative impact to U.S. sales, given the shift towards new adults pneumococcal vaccine.”

“In total, we expect other revenue to be higher in the second half versus first half of 2022.”

“We continue to assume a full year tax rate between 13.5% and 14.5%.”

“We are maintaining our gross margin expectation of between 74% and 74.5%.”

“We expect to have well more than double that between 2022 and 2028.”

“So, we remain really confident in our ability to drive strong growth for GARDASIL both in 2022 and the years to come.”

“We initially shared that we expected 50% of our growth to come from adjuvant, representing 30% of the U.S. business. We have now extended that to say 50% of the growth will come from adjuvant, representing 25% of our global business in the year 2025.”

“Specific then to this year, we will see a continuation of the supply into the market as we did in 2021, albeit not quite at the same step-up that we achieved in 2021.”

“In order to achieve that opportunity, we are building new facilities that will be coming online from 2023, 2024 and 2025.”

“So we're, therefore, not anticipating a significant impact to our GARDASIL performance in China as a result of what we're seeing in Shanghai at this moment in time.”

“Specific to China, we saw strong performance in the quarter, and we expect continued strong performance as we go through this year.”

“To the extent, we have excess cash, we will return it to shareholders through share repurchases.”

“Indeed, we've stated that we expect the revenue in year 2030 to be double the $5.7 billion we achieved in 2021.”