Amgen Inc (AMGN)

“As a result and consistent with 2025, we expect a meaningful sequential increase in operating expenses in the third quarter.”

“This outlook also includes a business development transaction, resulting in a $100 million upfront payment that will increase our non-GAAP R&D expense in the third quarter.”

“And we'll learn more about the impact of this medicine in that disease in H2 of this year.”

“We'll learn more about dazodalibep in H2 of this year.”

“Our Phase III study in eosinophilic esophagitis or EoE, is expected to complete in the second half of the year.”

“Results are expected later this year.”

“TEPEZZA is now launched in 13 countries around the world with an additional 6 planned in the coming months.”

“We believe UPLIZNA is well positioned to establish market leadership in this category.”

“We expect additional indications to deliver continued catalysts for growth in the future, and Jay will share more about those in a moment.”

“We continue to expect capital expenditures of approximately $2.6 billion in 2026, reflecting significant investment in our business to scale manufacturing capacity for volume growth, including for MariTide's launch.”

“We expect share repurchases not to exceed $3 billion.”

“We expect a non-GAAP tax rate in the range of 15.0% to 16.5%.”

“We continue to expect the full year non-GAAP operating margin as a percentage of product sales to be roughly 45% to 46%.”

“We now anticipate non-GAAP other income and expense to be in the range of $2.1 billion to $2.2 billion of expense in 2026.”

“We expect full year non-GAAP R&D expense to grow high single digits year-over-year, which includes 9 ongoing global Phase III clinical trials for MariTide.”

“For the full year, we now expect other revenue to be approximately $1.9 billion.”

“We now expect 2026 total revenues in the range of $38.2 billion to $39.4 billion and non-GAAP earnings per share between $22.30 and $23.50.”

“We're pleased with the momentum across our business and expect to reach more patients with our innovative medicines and biosimilars in the second half of the year than ever before as volume demand for our products continues to grow strongly.”

“We expect to be able to open these studies back for enrollment shortly.”

“We further expect second quarter operating margin to be in line with the first quarter operating margin.”

“These ranges reflect our confidence that the emerging growth drivers will more than offset the outgoing legacy brands.”

“I would not expect the cash-paying component of patients going through Amgen Now to be substantial.”

“We expect to be launching in the second-line indication across multiple markets this year.”

“We expect share repurchases not to exceed $3 billion.”

“We continue to expect the full-year non-GAAP operating margin as a percentage of product sales to be roughly 45% to 46%.”

“We now expect a non-GAAP tax rate in the range of 15% to 16.5%.”

“We now anticipate non-GAAP OI&E to be in the range of $2.2 billion to $2.3 billion of expense in 2026.”

“For the full year, we now expect other revenue to be in the range of $1.7 billion to $1.8 billion.”

“non-GAAP earnings per share to be between $21.70 and $23.10.”

“We expect 2026 total revenues in the range of $37.1 billion to $38.5 billion and non-GAAP earnings per share to be between $21.70 and $23.10.”

“We continue to expect capital expenditures of approximately $2.6 billion in 2026, reflecting significant investment in our business to scale manufacturing capacity for volume growth, including for Meritide’s launch.”

“We expect these factors will continue to negatively impact the cost of sales in future quarters.”

“Dazodalibet, our first-in-class CD40 ligand-targeting fusion protein, continues to progress with two Phase III studies in Sjogren’s disease now fully enrolled. These studies address both systemic and symptomatic disease, and both are expected to complete later this year.”

“Supported by a strong biological rationale, we expect to initiate two pivotal Phase III studies of aplisna in autoimmune hepatitis and chronic inflammatory demyelinating by the second half of this year.”

“Following our launch in Japan in 2025, we expect additional global launches of TEPEZZA in 2026 and beyond.”

“Erosion since loss of exclusivity remains in line with our expectations; we anticipate accelerated sales erosion over the remainder of 2026 driven by increased competition from multiple biosimilars.”

“With steady execution through the rest of the year, we expect once again to demonstrate that we can grow through a period of patent expiration, and deliver attractive performance for our shareholders with a strong portfolio of innovative medicines and biosimilars that meet the needs of patients with serious diseases.”

“we expect our rapidly growing products to offset the financial impact of patent expirations and increased competition while our next generation of molecules progress through the R&D pipeline, setting the stage for sustained long-term growth.”

“In line with lower product sales in the first quarter, we expect Q1 non-GAAP operating margin to be the lowest of the year and roughly the same as 2025.”

“We also expect Otezla and Enbrel to follow their historical pattern of lower sales in the first quarter relative to subsequent quarters and expect additional impact from denosumab biosimilar competition in Q1.”

“As you model the 2026, consistent with historical trends, tied to the annual United States health insurance cycle we expect a seasonal headwind to sales driven by benefit plan changes, insurance reverifications, and higher patient co-pay obligations.”

“But also our international launches, our launch in Japan has gone extremely well... TEPEZZA will be a a good growth driver for us this year.”

“and we expect completion of the trials later this year, and we'll inform later about our plan to communicate this information.”

“We have an ongoing subcutaneous Phase III clinical study in moderate to severe active TED. Fully enrolled, as we have shared and we expect to complete this study in the second half of this year.”

“In inflammation, the test by our Phase III program continues to advance, with ongoing studies in chronic obstructive pulmonary disease and eosinophilic esophagitis. Where we expect study completion in the second half of this year.”

“We are also advancing desodoliveb, our CD40 ligand targeting biotherapeutic with both Phase III studies in Sjogren's disease now fully enrolled and study completion expected in 2026.”

“and I expect that momentum to continue.”

“Increased investment has helped accelerate this growth which we expect to continue.”

“We plan to launch TEPEZZA in additional markets in 2026, expanding access to this important therapy globally.”

“We expect sales erosion driven by unfavorable pricing in The U.S., and generic launches particularly in The EU.”

“In 2026, we expect accelerated sales erosion driven by increased competition as multiple biosimilars have launched globally.”

“We expect capital expenditures of about $2.6 billion in 2026.”

“We expect share repurchases not to exceed $3 billion in 2026.”

“We expect non-GAAP R&D expense to grow low single digits excluding the roughly $300 million of business development in 2025.”

“we project the full-year non-GAAP operating margin as a percentage of product sales to be roughly 45% to 46%.”

“We expect this growth in 2026 to more than offset anticipated declines from increased denote biosimilar competition. Price declines for certain other products in 2026, and continued increases in 340B program utilization.”

“Additionally, note that we saw roughly $250 million of inventory build in 2025, that could potentially impact first-quarter sales.”

“I would imagine that that will increase and grow over time.”

“We are pleased to report that we have returned to our pre-Horizon capital structure ahead of plan, and we will achieve greater than $500 million in pretax cost synergies in 2025 in connection with the acquisition.”

“We look forward to the anticipated full confirmatory approval later this year.”

“In future quarters, we expect increased competition to negatively impact Prolia sales.”

“We continue to expect the full year non-GAAP operating margin as a percentage of product sales to be roughly 45%.”

“for WEZLANA in the United States, we continue to expect quarterly sales to fluctuate and do not expect any sales in the fourth quarter.”

“We now expect a non-GAAP tax rate in the range of 15.0% to 16.5%.”

“We now anticipate non-GAAP OI&E to be in the range of $2.1 billion to $2.2 billion in 2025.”

“For the full year, we now expect other revenue to be approximately $1.5 billion.”

“non-GAAP earnings per share between $20.60 and $21.40.”

“We are raising our 2025 guidance ranges for both revenue and non-GAAP earnings per share. We expect 2025 total revenues in the range of $35.8 billion to $36.6 billion and non-GAAP earnings per share between $20.60 and $21.40.”

“We expect our projects to continue to be on budget and on time.”

“It continues to be a strong product for us. We think it will continue to be that.”

“We don't anticipate an incremental step change going forward.”

“We expect this product to remain a growth driver throughout its life cycle.”

“we remain on track to initiate a potentially registration-enabling study in both adults and adolescents later this year.”

“triplet study that importantly adds checkpoint therapy to this pairing of bemarituzumab and chemotherapy will read out in the second half of this year or the first half of next year.”

“We expect share repurchases not to exceed $500 million in 2025.”

“We expect a non-GAAP tax rate of 14.5% to 16.0%.”

“For the full year, we continue to expect other revenue to be approximately $1.4 billion.”

“For WEZLANA and AMJEVITA sales in the United States, we continue to expect quarterly sales to fluctuate and do not expect any sales in the third quarter.”

“For 2025, we continue to expect capital expenditures of $2.3 billion to expand network capacity for our products across the portfolio and our innovative pipeline, including MariTide.”

“We look forward to the upcoming December 14 PDUFA date for generalized myasthenia gravis, recognizing ever more the significant unmet need for durable, convenient therapies consistently highlighted to us by treating physicians.”

“Beyond MariTide, in general medicine, we remain excited about data from the Repatha VESALIUS Phase III primary prevention study expected later this year.”

“With four Phase III studies underway and obstructive sleep apnea set to initiate this year, we are well positioned to deliver a robust and comprehensive clinical knowledge base.”

“On pricing, we expect less net price erosion than we've experienced historically.”

“we’re right on target with getting back to our pre-Horizon capital structure by the end of this year.”

“We are reaffirming our 2025 total revenue guidance in the range of $34.3 billion to $35.7 billion and also reaffirming our non-GAAP earnings per share guidance between $20 and $21.20.”

“I would anticipate both being able to grow prior to the availability of a subcutaneous form and then being able to accelerate that thereafter.”

“We anticipate launching there in the back half of the year.”

“So we are growing nicely. We continue to promote the primary care. We've invested in direct-to-consumer advertising now, and we expect a strong growth trajectory to come.”

“Free cash flow in the second quarter will be impacted by the shift in 2024 tax payments to Q2 '25 and the final $1.8 billion repatriation tax payment.”

“We continue to expect 2025 free cash flow performance to be roughly comparable to 2023.”

“We expect share repurchases not to exceed $500 million in 2025.”

“We continue to project that full year non-GAAP operating margin as a percentage of product sales to be roughly 46%.”

“For the full year, we continue to expect other revenue to be approximately $1.4 billion.”

“And for WEZLANA in the United States, we now expect quarterly sales to fluctuate and do not expect any sales in the second quarter following a large sales ordered in the first quarter.”

“For 2025, we expect no change in our capital expenditures outlook of $2.3 billion, which will support our products across the portfolio and our innovative pipeline, including MariTide.”

“The Horizon integration has progressed well, and we expect to reach the previously announced $500 million in pretax cost synergies by the end of this year.”

“In the second half of 2025, we expect data from FORTITUDE-102, the Phase III study of bemarituzumab combined with chemotherapy and nivolumab versus chemotherapy nivolumab alone.”

“We expect data this quarter from FORTITUDE-101, a Phase III study of bemarituzumab combined with mFOLFOX6 chemotherapy versus chemotherapy alone.”

“We look forward to additional data from the ROCKET program in the second half of 2025.”

“Beyond MariTide, in General Medicine, we look forward to data from the Repatha Vesalius Phase III primary prevention study in the second half of this year.”

“Looking ahead to the second half of 2025, we expect key data for MariTide, including both the ongoing Phase II type 2 diabetes study, which has completed enrollment as well as end of treatment period data from Part II of the ongoing Phase II chronic weight management study.”

“Beyond these first 2 studies, we anticipate initiating additional MariTide Phase III studies later this year, evaluating MariTide in specific obesity-related conditions.”

“We expect these recent launches will further enhance the robust growth and attractive returns from our biosimilar portfolio.”

“We do not expect similar reductions in inventory levels for the remainder of the year.”

“This guidance includes the estimated impact of implemented tariffs, but does not account for any tariffs that could be implemented in the future including potential sector-specific tariffs.”

“We're confident we can continue to grow that portfolio going forward.”

“I would agree that the slope of the biosimilar erosion is going to be, by definition of the timing, more towards the back end.”

“it does follow the pattern we see in some other products in our portfolio where that first quarter this year will be a little bit lower than the other 3 quarters, mostly a function of people having their insurance reverified and/or purchasing patterns in the market.”

“So Japan will be a very good source of growth for TEPEZZA internationally.”

“We have, as you know, an ongoing part 2 of our Phase II study in chronic weight management. That is a 52-week study, and we expect data readout late this year.”

“We have an event-driven readout expected in the second half of this year.”

“So we expect Repatha to continue to be a strong medicine going forward.”

“And we expect to see that continue.”

“Free cash flow in the first half of 2025 will be impacted by strong 2024 year-end collections timing, the shift in 2024 tax payments to the second quarter of 2025 and also the final $1.8 billion repatriation tax payment in the second quarter of 2025.”

“Similar to 2024, we expect share repurchases not to exceed $500 million in 2025, and we expect the share count in the first quarter of 2025 to be flat to the fourth quarter of 2024.”

“we expect the 2025 full year amount as a percentage of product sales to decline by approximately 1 to 2 percentage points year-over-year as we continue to drive efficiencies and prioritize resources”

“We project non-GAAP cost of sales to be in the range of 18% to 19% as a percentage of product sales for 2025.”

“we expect Q1 AMGEVITA sales in the U.S. to be in line with Q3 2024.”

“we expect Otezla and Enbrel to follow their typical pattern of lower sales in the first quarter relative to subsequent quarters.”

“For total company revenues, we expect each quarter of 2025 to have a relatively similar year-over-year growth rate.”

“This growth will more than offset declines due to the upcoming denosumab patent expiration as well as continued price declines across our portfolio in 2025.”

“We eagerly anticipate the 52-week data later this year, which will provide further insight into response and long-term durability.”

“we expect to initiate an additional Phase III outcome study in patients with elevated Lp(a) and at high risk for a first cardiovascular event late this year or in the first half of 2026.”

“The next wave of biosimilar launches continues in 2025.”

“In 2025, we expect to launch TEPEZZA in 7 additional countries.”

“We're moving quickly in international markets to secure regulatory approval for TEPEZZA, which will drive additional growth.”

“Moving forward, we expect less price erosion for Repatha with 2025 net price expected to decline by mid-single digits or less.”

“2025 promises to be another milestone year for our rapidly advancing pipeline with important Phase III data readouts for programs including across our general medicine, rare disease, inflammation and oncology portfolios.”

“In rare diseases, 2025 will be an exciting year. We look forward to regulatory approvals for TEPEZZA internationally and launches in new indications for UPLIZNA, further strengthening the growth trajectory of our rare disease business.”

“The Horizon integration is progressing well, and we expect to reach the previously announced $500 million in pretax cost synergies by year 3 post acquisition.”

“we're on track to double 2021 sales to over $4 billion by the end of the decade.”

“the olpasiran Phase III program, which as you heard is -- it has an event-driven outcome, expected a readout in the second half of next year.”

“We hope to initiate this study -- intend to initiate this study in the second half of this year or in the first half of next year.”

“Yes, as you picked up, Enbrel was impacted by 2 negative trends in the quarter... we are expecting continued net price declines going forward.”

“we do expect the momentum to play out here in the next several quarters.”

“We now expect OI&E to be approximately $2.4 billion to $2.5 billion, which includes the interest expense related to the $28 billion of debt raised for the Horizon acquisition.”

“For the full year, our total non-GAAP operating expenses are expected to grow approximately 25% year-over-year, including from the addition of Horizon.”

“Consistent with prior years, we expect Q4 non-GAAP operating expenses to be the highest of the year and expect approximately 28% of our full year operating expenses to be in the fourth quarter.”

“We now project full year new asset sales at approximately $400 million and other revenue at approximately $1.4 billion.”

“We do expect Q4 non-GAAP EPS to be lower than Q3 non-GAAP EPS, because of planned investment increases in our business, including key assets in our innovative pipeline beginning with MariTide and olpasiran and other strategic business investments.”

“We expect this optimized focus to gain traction over the next few quarters as physicians become more experienced identifying the right patients for treatment and navigating the reimbursement process to enable access to TEPEZZA.”

“Going forward, we expect continued declining net selling price, relatively stable volume, providing strong cash flow for our business.”

“we expect Repatha and Prolia alone will help over 11 million patients in 2024.”

“Our ongoing Phase II study is progressing well, and we look forward to sharing results later this year.”

“We remain on track to deleverage with line of sight to retiring greater than $10 billion of debt by the end of 2025.”

“As you nicely identified later this year, we will initiate an additional dedicated Phase II study that will characterize MariTide from the treatment of diabetes in patients with and without obesity.”

“These results won't be available until the second half of this year.”

“We expect OI&E to be approximately $2.5 billion, which includes the interest expense related to the $28 billion of debt raised for the Horizon acquisition.”

“Total non-GAAP operating expenses for the third quarter are expected to grow at a similar rate to the first two quarters of this year.”

“On revenues, we expect mid-single-digit growth quarter-over-quarter in the fourth quarter compared to Q3.”

“The Horizon integration is progressing well, and we expect to reach $500 million in pretax synergies by year three post acquisition, with roughly 50% to be realized by the end of this year.”

“We look forward to data readout in the second half of 2024.”

“The Phase III HORIZON study, part of this ROCKET program evaluates rocatinlimab monotherapy versus placebo in adults with moderate to severe atopic dermatitis. And it is ongoing with data readout anticipated in H2.”

“Beyond COPD, we continue to explore TEZSPIRE in separate Phase III studies in eosinophilic esophagitis and in chronic rhinosinusitis with nasal polyps, where top line data are expected later this year.”

“We are actively planning and expect to initiate a broad Phase III program in obesity, obesity-related conditions and diabetes, along with a Phase II trial investigating MariTide for the treatment of diabetes in patients with and without obesity.”

“We remain on track and look forward to top line 52-week data from the ongoing MariTide Phase II study in late 2024.”

“We expect to continue this momentum throughout 2024.”

“We see future growth opportunities for LUMAKRAS coming from launches in new markets and additional indications.”

“WEZLANA, a biosimilar to Stelara and BEKEMV, a biosimilar to Soliris, are both expected to launch in the U.S. in Q1 of 2025.”

“Going forward, we expect continued declining net selling price and relatively flat volumes.”

“The readout of the Phase I is on track for the first half of 2024.”

“We are totally on track for the readout.”

“Closing on our rare disease efforts, we're excited about Fipaxalparant, an LPAR1 antagonist being studied in idiopathic pulmonary fibrosis, on track for a Phase II proof-of-concept data readout in the second half of 2024.”

“Similar to 2023, we expect share repurchases not to exceed $500 million in 2024 we expect that we will continue to increase our dividend.”

“We anticipate non-GAAP OI&E to be in the range of $2.6 billion to $2.7 billion.”

“And for non-GAAP SG&A spend, we expect 2024 full year amounts as a percentage of product sales to be between 21% and 22%.”

“We project non-GAAP cost of sales to be in the range of 17% to 18% as a percentage of product sales for the 2024 year.”

“I would reiterate that we expect operating margin growth to accelerate in each of the quarters following the first quarter.”

“Note that we expect non-GAAP operating margin growth to accelerate in each of the quarters following the first quarter.”

“For the full year, we expect other revenue to be in the range of approximately $1.3 billion to $1.4 billion.”

“We will record a full year of legacy Horizon product sales, and we expect continued volume-driven growth in our priority products Repatha, TEZSPIRE, EVENITY, Prolia and BLINCYTO consistent with industry trends in our recent history, we expect mid single-digit price decline for our portfolio in 2024.”

“With UPLIZNA, we anticipate important Phase III data readouts this year in myasthenia gravis and IgG4-related disease.”

“Our expansion into both Japan and Europe is a high priority with regulatory review underway in Japan and filings in the EU throughout the year.”

“Given positive leading indicators and high unmet need, we see a long-term growth opportunity for TEPEZZA in the U.S., while also recognizing there is some time lag between our execution efforts and the realization of increased patient numbers.”

“Additionally, thanks to our efforts, we've been able to generate favorable medical policy changes for greater than 50% of U.S. covered lives, and we expect to continue this momentum throughout 2024.”

“Over time, we expect long-term growth in our biosimilars business to be driven by the addition of new molecules and additional launches.”

“Going forward, we expect net selling price to continue to decline year-over-year driven by higher rebates to maintain broad first-line payer coverage and changes in patient mix.”

“We see future growth opportunities for LUMAKRAS coming from launches in new markets and additional indications.”

“And in rare disease, we'll have Phase III data for UPLIZNA and myasthenia gravis and IgG4-related disease.”

“Our innovative drug substance plan under construction in North Carolina is expected to be operational by 2026.”

“I do think we've reached a tipping point in cardiology and I do think we've reached a tipping point with payers.”

“But we almost certainly expect the impact of the free goods program to continue to reduce and that will help us grow Otezla.”

“Given our confidence in these data, we are rapidly advancing tarlatamab into earlier lines of treatment with multiple Phase 3 studies underway or planned.”

“So we expect that at a full run rate, capitalizing on our in-place infrastructure internationally and manufacturing and process development that the margins in that business would be attractive in our hands.”

“What we think will happen and we're already seeing the very early signals of this is that we will continue to source our new growth from the topical patients, bio-naive patients.”

“With UPLIZNA it is the fastest-growing biologics in neuromyelitis optica spectrum disorders or NMOSD, and we see that momentum continue both in the U.S. as well as outside the U.S.”

“We've talked about the results for KRYSTEXXA and UPLIZNA, both those medicines performed really, really well. We have immunomodulation with KRYSTEXXA being a major driver since the label update last year. That has continued to drive uptake since that time. We see that continuing into the future.”

“We're looking forward to data from the Phase 2 trial next year which will really inform the breadth of the Phase 3 trial that we're contemplating, which could be quite large.”

“Our 2023 capital expenditures are now projected to be approximately $950 million, up from our prior guidance of $925 million.”

“We expect approximately 540 million shares to be outstanding in Q4.”

“For the full year, we anticipate a non-GAAP tax rate of 16.5% to 17%, down from prior guidance of 17.5% to 18.5%.”

“We expect to end 2023 with approximately $65 billion of long-term debt, including the current portion of it, and $11 billion of cash and cash equivalents.”

“And as you begin to model 2024, note that we expect 2024 OI&E to be consistent with this Q4 run rate.”

“We expect Q4 OI&E to be about $700 million, reflecting interest expense related to the Horizon financing, which will be included in our non-GAAP results effective October 6.”

“We now expect non-GAAP OI&E expenses to be in the range of $1.4 billion to $1.5 billion, up from our prior guidance of $1.1 billion to $1.2 billion.”

“We continue to expect non-GAAP SG&A to be down year-over-year as a percentage of product sales slightly.”

“We now expect our non-GAAP R&D expenses to increase from our prior guidance of 5% to about 10% year-over-year.”

“We continue to expect non-GAAP cost of sales as a percentage of product sales to be between 16% and 17%.”

“We continue to expect the full year 2023 operating margin as a percentage of product sales to be roughly 50%.”

“With the Horizon acquisition, we now anticipate full year non-GAAP operating expense for 2023 to increase from our previous estimate of 3% (ph) to approximately 10% versus last year.”

“We now expect other revenue for 2023 to be in the range of $1.2 billion to $1.3 billion versus our prior range of $1.1 billion to $1.3 billion.”

“And in addition, Q4 non-GAAP EPS will begin to include the recognition of interest expense related to the Horizon financing as a non-GAAP expense, important additional points to consider as you model the remainder of 2023.”

“However, we do expect Q4 non-GAAP EPS to be lower than Q3 non-GAAP EPS because of planned investment increases in our business, including key assets in our innovative pipeline, beginning with mari, Olpasiran and AMG 193, and other strategic business investments, including Generative AI use cases in all parts of our business.”

“We will add Horizon's business into Q4 without material non-GAAP EPS dilution.”

“For 2023 non-GAAP earnings per share, we are narrowing the range to $18.20 to $18.80 versus previous guidance of $17.80 to $18.80.”

“We are raising our 2023 revenue guidance to$28.0 billion to $28.4 billion versus previous guidance of $26.6 billion to $27.4 billion.”

“However, Q4 cash flow will be lower than historical patterns due to the timing of tax payments and Horizon transaction-related expenses.”

“We will continue to generate strong cash flows.”

“We expect Xaluritamig dose expansion cohorts to be fully enrolled by the end of the year, and are planning to initiate additional studies in patients with earlier-stage prostate cancer.”

“We see future growth in BLINCYTO from advancements into earlier lines of therapy and subcutaneous administration.”

“We see an opportunity for this basket of products to continue to generate robust sales.”

“In the fourth quarter, we expect to fulfill an additional $62 million order for Nplate by the U.S. government.”

“Looking forward, we expect to bring Tavneos to even more patients with ANCA-associated vasculitis.”

“For the remainder of 2023, we expect our improved coverage will lead to continued growth in new patients and declining net selling price.”

“With these increased investments, we expect to drive a return to growth for Otezla.”

“We expect volumes for Prolia to grow supported by real-world evidence data presented earlier this year that demonstrate Prolia's superiority in reducing fracture risk when compared to alendronate in treatment-naive patients with post-menopausal osteoporosis.”

“We see continued upside potential for BLINCYTO as it is increasingly used in earlier lines of therapy and as practice guidelines are updated to reflect the role this medicine can play in treating a broad range of patients with acute lymphoblastic leukemia.”

“The Horizon acquisition, coupled with our purchase of ChemoCentryx, which we acquired a little more than a year ago, gives Amgen a significant rare disease business that fits squarely within our overall strategy and will be additive to the growth we expect from our base business.”

“This drives our confidence in delivering against our 2023 objectives and keeps us in position to meet or beat our longer term commitments.”

“In terms of the oral obesity program, it’s moving through, it’s Phase 1, which includes, single dose and short-term multiple dose. We expect probably now to have data in the first half of next year.”

“So we’re – we see stability in Enbrel going forward.”

“we think that that will support sustained volume through the course of the year.”

“Our capital expenditure guidance remains unchanged at approximately $925 million in 2023.”

“For the full year, we anticipate a non-GAAP tax rate of 17.5% to 18.5% down from prior guidance of 18.0% to 19.0%.”

“We now expect non-GAAP other income and expenses to be in the range of $1.1 billion to $1.2 billion down from the prior guidance of $1.2 billion to $1.3 billion.”

“We continue to expect non-GAAP SG&A spend to be slightly down year-over-year as a percentage of product sales.”

“We now expect our non-GAAP R&D expenses in 2023 to increase about 5% year-over-year, which is higher than our prior guidance of 3% to 4%.”

“We continue to expect non-GAAP cost to sales as the percentage of product sales will be between 16% and 17%.”

“We continue to expect a full year 2023 operating margin as a percentage of product sales to be roughly 50%, although will vary in each of the remaining two quarters.”

“We now expect other revenue for 2023 to be in the range of $1.1 billion to $1.3 billion versus our prior range of $1.2 billion to $1.5 billion.”

“we now project full year Neulasta sales of approximately $800 million and full year combined KANJINT and MVASI sales of approximately $900 million.”

“we expect third quarter non-GAAP EPS to be lower compared to the second quarter, resulting from the expected Q3 sales and our investments in the business.”

“Although our results give us confidence to raise our full year guidance, we expect the third quarter sales maybe lower compared to the second quarter, due to the impact of the Medicare donut hole, which is more pronounced in the second half of the year, and also to certain favorable changes to estimated sales deductions in the second quarter.”

“We expect strong cash flow for the remainder of the year, consistent with our full year 2023 financial outlook and includes a non-GAAP operating margin of roughly 50%.”

“We expect our annual capital expenditures to begin to decline starting in 2024 with the completion and licensing of our Ohio plant and capital expenditures will then begin to return closer to historical levels over the coming years.”

“Global regulatory submissions are on track for E1910”

“Recently presented data from the SCARLET study provide the rationale to initiate a Phase 3 trial of LUMAKRAS combined with chemotherapy in first-line non-small cell lung cancer patients with PD-L1 negative tumors and Phase 1b data in combination with Vectibix and chemotherapy support the initiation of a Phase 3 study of LUMAKRAS with Vectibix and FOLFIRI in first-line G12C mutated colorectal cancer.”

“We also expect declining net selling price on a full year basis.”

“Our U.S. Otezla business has been impacted by free drug programs for newly launched topical and systemic competitors. And we expect new patient demand will continue to be affected by these programs for the remainder of 2023.”

“we are increasing investment to intensify our engagement with healthcare providers, bring our message directly to patients through direct-to-consumer media and drive urgency around LDLC testing and adherence to treatment guidelines.”

“We look forward to additional readouts from our pipeline in the second half of the year.”

“We think we've established good contractual commitments for this year. And we'll continue to battle with competitors if they come to market with a different device than is currently available. But we expect some continued pricing pressure there, as we've indicated.”

“And we would expect that, that will strengthen our new patient capture over the course of the year, and we expect to see good growth FOR OTEZLA for many years to come.”

“But we expect some continued pricing pressure there, as we've indicated.”

“We expect that to be a lower impact throughout the course of the year as well.”

“And as Murdo said, we're looking for a slowing year-over-year price erosion on that too.”

“Our capital expenditure guidance remains unchanged at approximately 925 million in 2023.”

“We continue to expect share repurchases not to exceed $500 million in 2023.”

“We expect a non-GAAP tax rate of 18% to 19%.”

“Non-GAAP spend is a percentage of product sales to slightly decrease year-over-year, driven by our ongoing digitalization, continuous improvement and productivity imperatives.”

“Non-GAAP R&D expenses in 2023 to remain unchanged and estimated to increase 3% to 4% year over year.”

“And we also expect cost of sales as a percentage of product sales to be between 16% and 17%.”

“We expect the 2023 operating margin as a percent of product sales to be roughly 50% and expect our second quarter operating margin to also be roughly 50%.”

“We expect a mid-single digit price decline for our portfolio in 2023.”

“For product sales, we project solid volume growth at a portfolio level and consistent with the first quarter.”

“We expect sequential growth in our free cash flow in the second quarter, although there may be an impact to Q2 and free cash flow from the expected closing of the Horizon acquisition due to the accounting treatment of certain items that were all expected in our Horizon acquisition financing and estimated deal costs as well as our previously announced restructuring in the first quarter.”

“We expect strong cash flow for the remainder of the year consistent with our full year 2023 financial outlook that includes a non-GAAP operating margin of roughly 50%.”

“We expect our annual capital expenditures to decline starting in 2024 with the completion and licensing of our Ohio plant.”

“We look forward to sharing initial data in the second half of 2023.”

“We'll have top line data from a potentially registrational Phase 2 study of tarlatamab and heavily pretreated patients with small cell lung cancer in the second half of 2023, potential milestone for patients with small cell lung cancer.”

“In oncology. global regulatory submissions are planned in the second half of 2023 for E1910, a Phase three trial led by the ECOG ACRIN Cooperative Group”

“Over time we expect long-term growth in our biosimilars business to be driven by the addition of new molecules and additional launches.”

“We expect continued net selling price deterioration and accelerating volume declines driven by increased competition.”

“We look forward to several data readouts from our pipeline, mainly in the second half of the year.”

“We do feel strongly that we will continue to be able to deliver on our 2x '21 sales by the end of the decade in our biosimilars business, so more than double our 2021 revenues.”

“Yes, I think we remain quite confident in our long-term growth of Otezla.”

“I think maybe to go back to the question Jay asked, too, we expect strong volume growth outside the United States in 2023.”

“And so we look forward to a year in 2023 with strong growth in our priority products, since of, Repatha, Prolia, TAVNEOS.”

“I wouldn't say we expect it to get larger but we will continue to see a decline in that business which is a function of the average selling price decline that we've seen thus far.”

“not only the Phase II potentially registrational trial readout in the second half of the year but also initiation of a Phase III trial in second-line disease.”

“I think it's fair to say that as additional entrants come into the market, net prices usually go down. We've seen that in our other biosimilars business but we would expect that to happen here.”

“We expect that insurance coverage to continue throughout the course of 2023.”

“So these revenue patterns, along with the timing of expenses, are expected to translate into our Q1 non-GAAP operating margin being below 50% as a percentage of product sales, although we continue to expect operating margin as a percentage of product sales to be roughly 50% for all of 2023.”

“The total of all these items creates greater than $400 million of headwinds versus the first quarter 2022.”

“We anticipate about $80 million of foreign exchange headwinds in Q1 2023 compared to Q1 2022.”

“And after we complete those facilities, we expect our capital expenditures to return to their historical levels.”

“We expect capital expenditures of approximately $925 million in 2023, consistent with our capital allocation priority to invest in our business, including in our new environmentally-friendly facilities in Ohio, North Carolina.”

“And for non-GAAP SG&A spend, we expect 2023 amounts as a percentage of product sales to slightly decrease year-over-year, driven by productivity improvements.”

“Note, however, there will be a negative impact in 2023 of approximately $125 million related to the amount of the PRET that is currently capitalized in inventory that will be charged to cost of goods sold in the first half of 2023, with most of the charge recognized in the first quarter without a corresponding tax benefit.”

“We have said we think this will be gradually slope on this launch and I'm going have to keep you apprised as we go forward.”