Q4 2020 Amgen Inc Earnings Call

All lines have been placed on mute to prevent any background noise. It will be a question and answer session at the conclusion of the last speaker's prepared remarks in order to ensure that everyone has a chance to participate we would like to request that you limit yourself to asking one question during the Q&A session to ask a question.

Unknown Executive: Speakers have been placed on mute to prevent any background noise. There will be a question and answer session at the conclusion of the last speaker's prepared remarks in order to ensure that everyone has a chance to ask questions. We would like to request that you limit yourself to asking one question during the Q&A session. To ask a question, please press star and then the number 1 on your telephone. To withdraw your question, press the. I would now like to introduce Arvind Sood, Vice President of Investor Relations. Sooth, you may now.

<unk> Press Star then the number one on your telephone keypad to withdraw your question press the pound key I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr. Sood, you may now begin.

Arvind Sood: Okay, thank you, Erica. Good afternoon, everybody. Welcome to our call to review our Q4 and full year financial results for 2020. I would say the strong execution despite the pandemic and pipeline advancement are two themes that were pervasive. So let's get after it. We'll stick to an efficient format of limited prepared comments, or the one question rule, as Erika pointed out, and the overall duration of the call to one hour.

Okay. Thank you Eric and good afternoon, everybody welcome to our call to review, our Q4 and full year financial results for 2020.

I would say the strong execution, despite the pandemic and pipeline advancement are two themes that are pervasive so let's get after it.

Well stick to an efficient format of limited prepared comments are one question Gordon as Eric pointed out and the overall duration of the call to one hour.

Unknown Executive: The slides have been posted. Just a quick reminder that we'll use non-GAAP financial measures in our presentation, and some of the statements will be forward-looking. Our SEC filings identify factors that could cause our actual results to differ materially. So with that, I would like to turn the call over to our chairman and CEO, Bob Bradway.

Like us have been posted just a quick reminder, that we use non-GAAP financial measures in our presentation.

Some other statements will be forward looking.

Our SEC filings identify factors that could cause our actual results to differ materially.

So, but I would like to turn the call over to our chairman and CEO and Bob <unk> Bob.

Bob Bradway: Thank you, Arvind. I thank all of you for joining our call. We'll start today by discussing Amgen's performance in 2020 and then provide some perspective on our priorities for 2021. By any measure, 2020 was a very successful year.

Great. Thank you Arvind and thank.

Thank all of you for joining our call.

I'll start today by discussing Amgen's performance in 2020, and then provide some perspective on our priorities for 2021.

Any measure 2020 was a very successful year for us.

Bob Bradway: Despite the disruption of COVID-19, we delivered strong sales and earnings. [inaudible] We advanced our innovative pipeline, most notably Sotiracib and Tezepelumab, both of which have received breakthrough therapy designation from the FDA. We successfully integrated Otesla, strengthening our decades-long leadership in inflammation with a $2 billion-plus product that we believe has runway for further global growth. We grew our sales outside the U.S. to more than $6 billion. [inaudible] by expanding our presence in China and Japan.

Quite the disruption of COVID-19, we delivered strong sales and earnings driven by volume growth of 15% for our product.

We advanced our innovative pipeline, most notably sooner rather than as Italian mab, both of which have received breakthrough therapy designation from the FDA.

We successfully integrated our Tesla strengthening our decades long leadership in inflammation with a $2 billion plus product that we believe has runway for further global growth.

We grew our sales outside the us to more than $6 billion.

Moving on delivering on long term goals by.

By expanding our presence in China and Japan.

Bob Bradway: We did all this while staying focused on the health and safety of our 24,000 employees around the world. To all of them, I want to say thank you for a job well done. As we look to 2021, we're embracing three realities. First, COVID-19 is leading to some lasting changes in how we do business. For example, we expect to continue leveraging digital capabilities to call on customers and run clinical trials around the world with improved speed, efficiency, and effectiveness. Additionally, we expect ongoing pressure on drug prices across the industry.

Successful transactions in both markets.

We did all this while staying focused on the health and safety of our 24000 employees around the world.

All of them I want to say, thank you for a job well done.

As we look to 2021, we're embracing three realities first COVID-19 is leading to some lasting changes in how we do business. For example, we expect to continue leveraging digital capabilities call on customers and run clinical trials around the world with improved speed efficiency.

Effectiveness.

We expect ongoing pressure.

On drug prices across the industry.

Bob Bradway: We are fortunate to have products like Repatha, Prolia, and Aimovig that meet the needs of millions of patients and can grow through increased penetration of the appropriate patient population. Our industry-leading portfolio of biosimilars is also well positioned for the future. Third, capital continues to flow into our sector. We've entered a time of intense competition where speed of execution is paramount. We've built a track record.

We are fortunate to have products like for past Prolia and Amazon that meet the needs of millions of patients.

Can grow through increased penetration of the appropriate patient populations.

Our industry, leading portfolio of Biosimilars is also well positioned huge.

Third as capital continues to flow into our sector. We've entered a time of intense competition, where speed of execution is paramount.

We've built a track record.

Bob Bradway: [inaudible] We've shown that with innovative first-in-class medicines like Repatha, the first approved PCSK9 inhibitor, and Amavig, the first approved CGRP inhibitor. We've shown it also with biosimilars like Mvasi and Congenti, the first approved biosimilars to Avastin and Herceptin here in the U.S., and we're doing it right now with the rest. [inaudible] We expect to do it again later in the year with Tezapelumab as the first TSLP inhibitor. We're excited about our pipeline and plan on increasing our R&D investment in 2021.

Shrink quality and speed.

Shown that with innovative first in class medicines like for Pasha. The first approved <unk> inhibitor the name of the.

The first approved <unk> inhibitor with <unk>.

It also with Biosimilars like <unk>, the first approved Biosimilar to Avastin and Herceptin here in the U S.

And we're doing it right now sort of acid. The first <unk> inhibitor to be filed for approval just 28 months. After we dosed our first patient.

And we expect to do it again later in the year anticipating your map is the first <unk> inhibitor.

We're excited about our pipeline and plan on increasing our R&D investment in 2021 day.

Bob Bradway: Dave will speak in a moment about some of our promising mid-stage pipeline candidates. But since this is the time of year when I like to address our long-term investors, I want to focus for a moment on a couple of areas central to our early research strategy. These are areas where we are building differentiated capabilities. First, in human genetics, where we have industry-leading capabilities, we are adding to our database approximately a million subjects from the U.S. and the U.K. for whom we will have extensive phenotypic and genotypic information. This will augment the data we already have on in excess of a million and a half.

David will speak in a moment about some of our promising mid stage pipeline candidates.

Since this is the time of year when I'd like to address our long term investments I want to focus for a moment a couple of areas central to our early research strategy.

These are areas, where we are building differentiated capabilities.

First in human genetics, where we have industry, leading capabilities, we are adding to our database of approximately a 1 million subjects from the us and the UK for whom we will have extensive certificate genotypic information.

Augment the data we already have on an excess of $1 million five individuals.

In addition, we're pioneering the use of large scale proteomics to measure the relative levels of some 5000 different proteins in the blood.

Bob Bradway: In addition, we're pioneering the use of large-scale proteomics to measure the relative levels of some 5,000 different proteins in the blood. We're excited about the insights we're generating from this genomic proteomic work. I expect to benefit in the selection of new drug targets and clinical trial design. However, we believe the opportunity is broader than that, and our efforts are not just limited to degrading proteins.

We're excited about the insights we are generating from this genomic and Proteomic work.

Spec to benefit in the selection of new drug targets and clinical trial design.

There is growing interest in our industry in the area of targeted protein degradation.

We believe the opportunity is broader than that and our efforts are not just limited to degrading proteins.

We're looking at integrating other biologic molecules as well.

Bob Bradway: We're looking at degrading other biological molecules as well. We're designing molecules to have multi-specific activity through a principle we call induced. The idea is to use this platform to dramatically expand the universe of druggable targets. It's still early days in the field, but I wanted to flag it as an area where we want to immerse ourselves in time as an industry leader. All of our work is taking place at a time when more is expected of companies than ever before, and we are advancing an ambitious ESG agenda that includes providing medicines at no cost to low-income patients and funding world-class STEM education programs.

We're designing molecules to have multi specific activity through a principle, we call induced proximity.

The idea is to use this platform to dramatically expand the universe of <unk> targets.

Still early days in the field, but I wanted to flag it as an area, where we want to emerge through time as an industry leader.

All of our work is taking place at a time when more is expected of companies than ever before.

Amgen is advancing an ambitious ESG agenda that includes providing medicines at no cost low income patients and funding world class stem education programs.

Respect to the environment, we're committed to achieving carbon neutrality by 2027, along with a 40% reduction in water use and 75% reduction in waste.

Bob Bradway: With respect to the environment, we're committed to achieving carbon neutrality by 2027, along with a 40% reduction in water use. [Inaudible] In summary, our success in 2020 gives me great confidence in our ability to deliver in 2021 and beyond. The world needs more innovation, not less, and we've proven ourselves ready, willing, and able to provide it. I look forward to your questions a little later on in the call. Right now, I want to turn over to Dave Reese, our head of R&D. Thanks, Bob.

In summary, our success in 2020, it gives me great confidence in our ability to deliver in 2021 and beyond.

The world needs more innovation, not less and we've proven ourselves ready willing and able to provide us.

Look forward to your questions a little later on in the call right now, let me turn it over to Dave Reese, our head of R&D.

Thanks, Bob and good afternoon, everyone I'll begin today with <unk>, our first in class <unk> inhibitor.

Date more than 700 patients have been treated across five continents, and we are accelerating this groundbreaking program into new indications and earlier lines of therapy.

Few days ago, we presented the first pivotal data for our <unk> inhibitor at the World Conference on lung cancer, where we reported on 126 patients with second line plus non small cell lung cancer.

David M. Reese: Good afternoon, everyone. I'll begin today with photoracet, a first-in-class KRAS G12C inhibitor. To date, more than 700 patients have been treated across five continents, and we are accelerating this groundbreaking program into new indications and earlier lines of therapy. A few days ago, we presented the first pivotal data for a KRAS T12C inhibitor at the World Conference on Lung Cancer, where we reported on 126 patients with second-line plus non-small cell lung cancer. Photoracid drove rapid, deep, and durable responses across a broad range of mutational profiles and subgroups with poor prognosis.

So to our asset drove rapid deep and durable responses across a broad range of mutational profiles and subgroups with poor prognoses and.

And a centrally adjudicated intent to treat analysis. The objective response rate was 37%, including three complete remissions progression free survival was six eight months in duration of response was 10 months importantly, <unk> demonstrated a very tolerable and differentiated clinical profile and.

Based on these data we completed regulatory submissions in the United States and EU in December or recently, we submitted files in Canada, U K, Brazil, and Australia with additional global submissions anticipated in the coming weeks and months and launch preparations are well advance.

The phase III non small cell lung cancer monotherapy study versus Docetaxel continues to advance nicely as do our 10 combination cohorts and phase III colorectal study with data expected from these latter two beginning in the first half of this year.

David M. Reese: In a centrally adjudicated, intent-to-treat analysis, the objective response rate was 37%, including three complete remissions, progression-free survival was 6.8 months, and duration of response was 10 months. Importantly, SOTARASAV demonstrated a very tolerable and differentiated clinical profile, and based on these data, we completed regulatory submissions in the United States and EU in December. More recently, we submitted files in Canada, the UK, Brazil, and Australia, with additional global submissions anticipated in the coming weeks and months, and launch preparations are well advanced.

We will initiate a phase II study in first line non small cell lung cancer in the second quarter, wherein we will investigate sooner as a mono therapy in patients most likely to benefit based on tumor profiling for example, those tumors harboring SDK 11.

Patients.

Finally, we recently cleared the safety hurdle at the full soda rasset dose and our <unk> inhibitor combination study and have completed enrollment in an expansion cohort.

In inflammation, along with our partner Astrazeneca, we look forward to presenting the results from the phase III Navigator study at the American Academy of allergy asthma and immunology virtual annual meeting also known as Quad AI at the end of February.

You may have seen the abstract posting yesterday with results from the primary and key secondary endpoints data pack in our view provides a compelling rationale for the potential utility of <unk> in a broad population of patients with severe uncontrolled asthma, including those with low eosinophil counts or we have.

David M. Reese: The Phase 3 non-small cell lung cancer monotherapy study versus docetaxel continues to advance nicely, as do our 10 combination cohorts and Phase 2 colorectal study. Data from these latter two is expected from these latter two beginning in the first half of this year.

Breakthrough therapy designation in the United States.

We are working closely with Astrazeneca on our U S and EU filing packages, which we expect to submit in the first half.

David M. Reese: We will initiate a Phase 2 study in first-line non-small cell lung cancer in the second quarter where we will investigate soduracid monotherapy in patients most likely to benefit based on tumor profiling, for example, those tumors harboring STK-11 mutations. Finally, we recently cleared the safety hurdle at the full sodoracid dose in our MEK inhibitor combination study and have completed enrollment in an expansion cohort. Inflammation, along with our partner AstraZeneca, we look forward to presenting the results from the Phase 3 Navigator Study at the American Academy of Allergy, Asthma, and Immunology Virtual Annual Meeting, also known as Quad AI, at the end of February. You may have seen the abstract posting yesterday with results from the primary and key secondary end points.

Turning to our bite platform, we are particularly excited about the rapid progress we are making with two solid tumor programs AMG 160, <unk> targeting prostate specific membrane antigen PSM for.

For castrate resistant prostate cancer, and AMG 757 targeting DLL three for small cell lung cancer.

AMG 160 is currently in dose expansion and we expect to advance AMG 757 into dose expansion in the coming months.

Quite pleased with the clinical profiles, we are seeing with both of these molecules.

And as you will see in our press release, we also continue to actively prioritize our oncology portfolio.

And migraine <unk> continues to demonstrate important benefits for patients as our colleagues at Novartis announced positive phase <unk> results, showing superior efficacy and safety of AME, a big over to pyramid in the migraine prevention setting.

Finally, our Biosimilars portfolio continues to advance and we have completed enrollment in our phase III study of ABP $905 nine our Biosimilar soliris.

In closing I'd like to thank our staff for their ongoing efforts to deliver our portfolio for patients Murdo.

David M. Reese: Data, in our view, provide a compelling rationale for the potential utility of tezapelumab in a broad population of patients with severe uncontrolled asthma. [Inaudible] We are working closely with AstraZeneca on our US and EU filing packages, which we expect to submit in the first half. Turning to our BITE platform, we're particularly excited about the rapid progress we are making with two solid tumor programs, AMG-160 targeting prostate-specific membrane antigen, or PSMA, for castrate-resistant prostate cancer, and AMG-757 targeting DLL-3 for small cell lung cancer.

Thanks, Dave 2020 product sales grew 9% year over year, driven by 15% volume growth with roughly equal growth rates in the U S and internationally stock.

Starting with our innovative portfolio of Prolia grew year over year, despite significant impacts from the pandemic and of energy sales increased 85% year over year, driven by strong volume growth.

<unk> is now annualizing at over $1 billion in revenues with 67% year over year volume growth in the first full year since acquisition, we have seamlessly integrated with Tesla growing total prescriptions by 13% year over year, and finally, our biosimilars portfolio totaled $1 seven.

David M. Reese: Amg 160 is currently in dose expansion, and we expect to advance Amg 757 into dose expansion in the coming months. We're quite pleased with the clinical profiles we are seeing with both of these. And, as you will see in our press release, we also continue to actively prioritize our oncology portfolio. In migraine, Amavig continues to demonstrate important benefits for patients, as our colleagues at Novartis announced positive Phase IV results showing superior efficacy and safety of Amavig over Topiramate in the migraine prevention setting.

In sales.

Moving to fourth quarter performance product sales grew 8% year over year, driven by 13% volume growth.

In our bone franchise, we remain focused on ensuring patient continuity by yearend osteoporosis diagnoses reached approximately 80% of pre COVID-19 levels, leading to a positive trend in new patient starts entering 2021.

In Q4, Prolia as repeat patient numbers were lower than historical trends as a result of the echo effect of Covid disruption in Q2.

David M. Reese: Finally, our biosimilars portfolio continues to advance, and we have completed enrollment in our Phase III study of ABP959, our biosimilar cilirus. In closing, I'd like to thank our staff for their ongoing efforts to deliver our portfolio for patients.

<unk> sales grew quarter over quarter, we believe us entities unique bone building profile will continue to drive growth in our franchise US physicians appreciate its benefit risk profile for treating their high risk post fracture patients.

In cardiovascular with pathway remains the global <unk> leader.

Net sales in Q4 were $253 million driven by sequential volume growth and stable U S. Net price as we enter 2021, we expect continued momentum for this brand globally driven by growth from international markets improved U S. Pbms formulary.

Murdo Gordon: Murdo?

Murdo Gordon: Thanks, Dave. 2020 product sales grew 9% year over year driven by 15% volume growth, with roughly equal growth rates in the US and internationally. Starting with our innovative portfolio, Prolia grew year-over-year despite significant impacts from the pandemic, and Avenity sales increased 85% year-over-year driven by strong volume growth. Repatha is now annualizing at over $1 billion in revenues, with 67% year-over-year volume

<unk> and relatively stable net price in the U S.

Moving on to <unk>, which is the market leader in the highly competitive cgmp class volumes grew 21% year over year in the fourth quarter, but remained flat quarter over quarter as the pandemic negatively impacted new patient starts.

Next to parse a bit.

Q4 sales declined 8% quarter over quarter in the us as some customers decreased utilization, while others built inventory in advance of the January reimbursement change with partial <unk> inclusion in the end stage renal disease bundle, we expect sales to decline by approximately 40 to 50.

Murdo Gordon: In the first full year since acquisition, we've seamlessly integrated Otesla, growing total prescriptions by 13% year-over-year. And finally, our biosimilars portfolio totaled $1.7 billion in sales. Moving to fourth-quarter performance, product sales grew 8% year over year, driven by 13% volume growth. In our bone franchise, we remained focused on ensuring patient continuity. By year end, osteoporosis diagnoses reached approximately 80% of pre-COVID levels, leading to a positive trend in new patient starts entering 2021. However, in Q4, Prolia's repeat patient numbers were lower than historical trends as a result of the echo effect of COVID disruption in Q2.

80% in 2021 as U S dialysis centers update their treatment protocols to accommodate generic forms of cinacalcet.

We also expect sales in Q1 to be the lowest of the year us customers deplete $40 million of inventory build in the second half of 2020.

For patients on hemodialysis possible as the only IV administered casselman ethic that lowers and maintain key secondary hyperparathyroidism lab values also partially both offers providers control over kauffmann metic delivery and the opportunity to reduce patient Bill pill.

Murdo Gordon: Evenity sales grew quarter over quarter. We believe Evenity's unique bone-building profile will continue to drive growth in our franchise as physicians appreciate its benefit-risk profile for treating their high-risk post-fracture patients. In cardiovascular, Repatha remains the global PCSK9 leader.

<unk>.

Transitioning to our inflammation portfolio with Tesla sales were $617 million in Q4, driven by a 13% year over year increase in total U S prescriptions, we see attractive future growth opportunities through global launches and our planned submission for the mild to moderate psoriasis indication.

Murdo Gordon: Net sales in Q4 were $253 million, driven by sequential volume growth and stable U.S. net price. As we enter 2021, we expect continued momentum for this brand globally, driven by growth from international markets, improved US PBM formulary position, and relatively stable net price in the US. Moving on to Imovig, which is the market leader in the highly competitive CGRP class.

Asian in the us in the coming weeks.

With Enbrel fourth quarter sales declined 5% year over year volumes declined from gradual share loss, coupled with slower growth in the rheumatology segment, which we attribute in part to the pandemic.

For 2020 net price declined in the low single digits, and we expect volume and net price trends to persist in 2021 and.

Enbrel has an established record of safety and efficacy and we will continue to invest in innovative solutions to enhance the patient experience.

Switching to Biosimilars Q4 sales were $541 million driven by volume growth, which was partially offset by declines in net selling price.

Murdo Gordon: Volumes grew 21% year over year in the fourth quarter, but remained flat quarter over quarter as the pandemic negatively impacted new patient enrollment. [inaudible] Q4 sales declined 8% quarter over quarter in the U.S. as some customers decreased utilization while others built inventory in advance of the January reimbursement change. With Parsipov's inclusion in the end-stage renal disease bundle, we expect sales to decline by approximately 40-50% in 2021 as U.S. dialysis centers update their treatment protocols to accommodate generic forms of Sinocalceps.

We are leading in Biosimilar share in Europe for Amgen Vita and in the U S for <unk> with respect to 48% and 41% average share in Q4.

We recently launched our fifth Biosimilar rehab any biosimilar to Rituxan.

For 2021, we expect Biosimilar volume growth to be partially offset by a decline in net selling prices due to increased competition.

And oncology Neulasta on Pearl remains the preferred long acting G CSF with 54% share of volume in the quarter on parole continues to demonstrate the value of innovation, allowing patients to treat to receive their G. CSF treatment without having to return to their doctor's office or other sites of care.

Administration.

Overall, neulasta sales decreased 19% year over year, driven by declines in volume and net selling price and the most recent published average selling price for Neulasta in the U S declined 28% year over year.

Murdo Gordon: We also expect sales in Q1 to be the lowest of the year as customers deplete $40 million of inventory billed in the second half of 2020. For patients on hemodialysis, Parsibiv is the only IV-administered calcium emetic that lowers and maintains key secondary hyperparathyroidism lab values.

Going forward, we expect the price and volume trends to persist as Biosimilar competition increases.

Looking ahead, we're excited about new opportunities across our business internationally. We recently received national reimbursement drug list thing for Prolia, which will accelerate growth in China and.

Murdo Gordon: Also, Parsibhv offers providers control over calcium emetic delivery and the opportunity to reduce patient pill burden. Transitioning to our inflammation portfolio, Otesla sales were $617 million in Q4, driven by a 13% year-over-year increase in total U.S. prescriptions. We see attractive future growth opportunities through global launches and our planned submission for the mild to moderate psoriasis indication in the U.S. in the coming weeks. With Enbrel, fourth quarter sales declined 5% year over year, volumes declined from gradual share loss coupled with slower growth in the rheumatology segment, which we attribute in part to the pandemic. For 2020, net price declined in the low single digits, and we expect volume and net price trends to persist in 2021.

In Japan, we are preparing for the launch of <unk> and we're planning for the launch of our Biosimilar brands across multiple markets in 2021.

Finally, our team is ready to launch so to us of upon approval and we're excited to establish it as a foundational therapy for patients with advanced lung cancer.

We're also preparing for the launch of <unk> Italian map with our partner Astrazeneca and are enthusiastic about the prospect of having a therapy that can help treat the $2 5 million people in the world living with severe uncontrolled asthma overall.

Overall, I'm pleased with our Q4 and full year performance and look forward to Amgen, serving more patients in 2021, now I'll turn it over to Peter.

Thank you Murdo good afternoon, and good evening everyone.

We are pleased with our strong execution and performance in the fourth quarter and for the full year 2020.

In Q4, we delivered 7% revenue and 5% non-GAAP EPS year over year growth.

For the full year, we delivered 9% revenue at 12% non-GAAP EPS year over year growth.

Murdo Gordon: Enbrel has an established record of safety and efficacy, and we will continue to invest in innovative solutions to enhance the patient experience. Switching to biosimilars, Q4 sales were $541 million, driven by volume growth, which was partially offset by declines in net selling price. We are leading in biosimilar share in Europe for Amgevita and in the US for Mvasi and Canginti, with a respective 48% and 41% average share in Q4. We recently launched our fifth biosimilar, Reabni, a biosimilar to Rituximab.

As Murdo mentioned, both Q4 and the full year benefited from volume driven sales growth of 13% and 15% respectively.

Non-GAAP operating expenses increased 9% year over year in the fourth quarter its been accelerated to advance our innovative pipeline drive volume growth for much of our portfolio around the globe and prepare for future launches, particularly for solder asset intensity value map.

Operating expense grew 7% for the full year, including a full year about Tesla related activities and expenses.

Free cash flow for the fourth quarter and the full year with 2.0 at $9 9 billion respectively.

Now turning to the outlook for the business for 2021 on page 37.

We look forward to investing in innovation in 2021, and then launching new products. We will also continue to execute on our volume driven growth strategy due.

Murdo Gordon: For 2021, we expect biosimilar volume growth to be partially offset by a decline in net selling prices due to increased competition. In oncology, Nelasta OnPro remains the preferred long-acting GCSF with 54% share of volume in the quarter. OnPro continues to demonstrate the value of innovation, allowing patients to receive their GCSF treatment without having to return to their doctor's office or other site of care for administration. Overall, Nelasta sales decreased 19% year-over-year driven by declines in volume and net selling price, and the most recent published average selling price for Nelasta in the U.S. declined 28% year-over-year.

Due to Covid, we also anticipate some uncertainty and quarter to quarter variability in revenue and earnings throughout 2021 with potential recovery later in the year contingent upon the speed and effectiveness of global vaccination.

Our 2021 revenue guidance is 25, 8% to $26 6 billion and our non-GAAP earnings per share guidance of $16 to $17 per share.

GAAP earnings per share guidance is $12 12 per share to $13 17 per share.

Now, let me mention several key assumptions embedded in our guidance.

Our revenue range reflects volume growth from Prolia of Tesla for Panther entity, a moving and our Biosimilars portfolio and importantly, our innovative oncology portfolio at.

At the same time, we expect continued competition against our Filgrastim and Esa franchises as well as accelerating erosion in the us parts of us sales as Murdo highlighted.

We experienced a 6% decline in net selling prices globally in 2020 for 2021, we again expect mid single digit price declines.

Murdo Gordon: Going forward, we expect the price and volume trends to persist as biosimilar competition increases. Looking ahead, we're excited about new opportunities across our business. Internationally, we recently received national reimbursement drug listing for prolia, which will accelerate growth in China. In Japan, we're preparing for the launch of Amavig, and we're planning for the launch of our biosimilar brands across multiple markets in 2021. Finally, our team is ready to launch Sotiracib upon approval, and we're excited to establish it as a foundational therapy for patients with advanced lung cancer.

A couple of points to recall when considering Q1 of 2021.

Historically, the first quarter represents the lowest product sales quarter of the year with planned changes insurance re verifications and higher co pay expenses as U S patients work through deductibles, especially for products, including Enbrel.

<unk> and <unk>.

Additionally, I want to remind everyone that in Q1 2020, enbrel benefited from approximately $115 a favorable changes to estimated sales deductions and the entire portfolio is roughly $100 million in inventory build due to COVID-19.

So as a proportion of our full year sales, we expect Q1 2021 to be a slightly lower percentage than the 24%. It was in Q1 2020.

Murdo Gordon: We're also preparing for the launch of Tezapelimab with our partner AstraZeneca and are enthusiastic about the prospect of having a therapy that can help treat the 2.5 million people in the world living with severe uncontrolled asthma. Overall, I'm pleased with our Q4 and full year performance and look forward to Amgen serving more patients in 2021.

We expect other revenue to be in the range of approximately one four to $1 5 billion for the full year 2021.

This includes revenues from COVID-19, antibody manufacturing and profit share agreement with Lilly under which we expect to begin shipping in the second quarter.

We expect 2021 total non-GAAP operating expenses to grow at a rate similar to the 7% 2020 non-GAAP operating expense growth as we continue to invest in innovation launches, a new product and Digitization efforts.

Peter H. Griffith: Thank you, Murdo. Good afternoon and good evening, everyone.

Peter H. Griffith: We are pleased with our strong execution and performance in the fourth quarter and for the full year 2020. In Q4, we delivered 7% revenue and 5% non-GAAP EPS year-over-year growth. For the full year, we delivered 9% revenue and 12% non-GAAP EPS year-over-year growth. As Murdo mentioned, both Q4 and the full year benefited from volume-driven sales growth of 13 and 15 percent, respectively. Non-GAAP operating expenses increased 9% year-over-year.

We have created an industry, leading cost structure and expect an operating margin of roughly 50% in 2021.

Cost of sales as a percentage of product sales will increase to a range of 16% to 17% due to an evolving product mix and higher royalties and profit share payments additional.

Additionally cost of sales will increase in connection with our manufacturing agreement with Lilly.

As I mentioned previously the revenues and profit share will be included in other revenue.

Research and development expenses will increase as our pipeline advances with year over year increases in early and late stage investments.

And SG&A will decline primarily due to changes in our commercial model, including an increased focus on digital efforts.

Peter H. Griffith: Accelerated, to advance our innovative pipeline, drive volume growth for much of our portfolio around the globe, and prepare for future launches, particularly for soda acid and tezepelumab. Operating expense grew 7% for the full year, including a full year of Tesla-related activities and expenses. Free cash flow for the fourth quarter and the full year was $2.0 and $9.9 billion, respectively.

Now, let me take a moment to explain an update we are making to our non-GAAP policy.

Effective January 2021, our non-GAAP results will no longer include fair value adjustments to equity investments.

These adjustments to equity investments have historically been recorded in other income and expenses and were positive in our 2020 non-GAAP results.

This change will not apply to our strategic investment in Beijing, which is included in our non-GAAP results and is accounted for under the equity method of accounting.

The press release contains the pro forma 2020 results by quarter under our updated policy.

We will also now US updated adjusted 2020 amounts that conform to this policy for comparison purposes going forward.

Peter H. Griffith: Now turning to the outlook for the business for 2021 on page 37, we look forward to investing in innovation in 2021 and in launching new products. We will also continue to execute on our volume-driven growth strategy. Due to COVID, we also anticipate some uncertainty and quarter-to-quarter variability in revenue and earnings throughout 2021, with potential recovery later in the year contingent upon the speed and effectiveness of global vaccination.

Under our updated non-GAAP policy that I, just explained here's our guidance for other income and expense.

We anticipate non-GAAP other income expense in the range of one three to one 5 billion of expense. This 2021 guidance reflects incorporation up four quarters at Beijing results versus three quarters in 2020, which are recorded on a one quarter lag.

Recall that we only use the limited publicly available consensus estimates for Beijing in connection with our guidance and thus may experience additional variability depending on Beijing actual results.

Our basis in Beijing as at December 31, 2020 was approximately $2 9 billion.

Peter H. Griffith: Our 2021 revenue guidance is $25.8 to $26.6 billion, and our non-GAAP earnings per share guidance is $16 to $17 per share. GAAP earnings per share guidance is $12.12 per share to $13.17 per share. Now, let me mention several key assumptions embedded in our guidance.

And this long term investment is valued at approximately $6 billion today based upon the current U S market price.

Our non-GAAP.

Tax rate guidance is 13% to 14% and we expect capital expenditures of approximately 900 million this year, including investments in additional manufacturing and other capacity to support our volume driven growth strategy.

As well as an environmental environmental sustainability initiatives that will enable our global operations to achieve carbon neutrality by 2027 and also in our Digitization efforts to continue to scale up and integrate data and analytics and everything we do at Amgen.

Peter H. Griffith: First, our revenue range reflects volume growth from Prolea, Otesla, Repatha, Avenidae, Amavig, and our biosimilars portfolio, and importantly, our innovative oncology portfolio. At the same time, we expect continued competition from our Philgrastom and ESA franchises. As well as accelerating erosion in U.S. parsnip sales, as Murdo highlighted, we experienced a 6% decline in net selling prices globally in 2020. For 2021, we again expect a mid-single-digit price decline. Here are a couple of points to recall when considering Q1 of 2021. Historically, the first quarter represents the lowest product sales quarter of the year, with plan changes, insurance re-verifications, and higher copay expenses as U.S. patients work through deductions, especially for products including Embrl, Otezla, and Amovig.

And finally, our capital allocation hierarchy remains unchanged.

After both internal and external innovation and then investing in our capital expenditures, we remain committed to returning capital to shareholders in the form of growing dividend.

Including the 10% increase in the first quarter of 2021 to $1 76 per share.

We anticipate opportunistic share repurchases in the range of three to 4 billion subject to our board's authorization.

So in summary, we delivered for patients every patient every time and for our investors in a challenging year that included the greatest public health crisis in 100 years and the greatest economic disruptions since the great Depression.

And we are confident in the outlook for Amgen success in 2021 and beyond.

This concludes the financial update I will now turn the call back over to Bob.

Okay. Thank you Peter and Eric Let me invite you to remind our callers.

For Q&A and let's begin the <unk>.

A question and session.

Yes.

Reminder, to ask a question you will need to press star one on your telephone.

Paul Your question press the pound key please standby, while we compile the Q&A roster.

Your first question in queue is from Alethia young with Cantor with Cantor Fitzgerald.

Peter H. Griffith: Additionally, I want to remind everyone that in Q1 2020, Embrill benefited from approximately $115 of favorable changes to estimated sales deductions, and the entire portfolio saw roughly $100 million in inventory write-down due to COVID. So, as a proportion of our full-year sales, we expect Q1 2021 to be a slightly lower percentage than the 24% it was in Q1 2020. We expect other revenue to be in the range of approximately $1.4 to $1.5 billion for the full year 2021.

Hey, guys. Thanks for taking my question and congrats on the solid guide and great quarter.

Maybe if you guys could talk a little bit about obviously.

Okay, Ras program and the combinations and maybe perhaps kind of I know, they're probably early phase one study, but what you're kind of looking at the green from some of these different combinations I know you get asked a lot about this but just kind of as we're getting closer and closer like how do you think about unpacking that with different indications. Thanks.

Hi, Alicia Thanks for the question, Yes, we do get this one quite a bit about the combinations.

What I will say us theres no generic answer here.

It's going to depend on line of therapy and indication non.

Non small cell lung cancer of course, but colorectal cancer and then some of the other indications.

Beyond that typically youre looking for 15 20, 30% increment on any given endpoint beyond our standard of care, but also looking at the totality of the data I think in many of these settings in particular progression free survival.

Peter H. Griffith: This includes revenues from COVID-19 antibody manufacturing and a profit share agreement with Lilly, under which we expect to begin shipping in the second quarter. We expect 2021 total non-GAAP operating expenses to grow at a rate similar to the 7% 2020 non-GAAP operating expense growth as we continue to invest in innovation, launches of new products, and digitization. We have created an industry-leading cost structure and expect an operating margin of roughly 50% in 2021. However, cost of sales as a percent of product sales will increase to a range of 16 to 17% due to an evolving

And ultimately overall survival so.

Given the safety profile, we've demonstrated to date.

Those are the sort of efficacy metrics that will probably take a look at.

Your next question is from Michael Yee with Jefferies.

Hi, Thanks.

I bet Youre going at a lot of combo K Roger question, Sean I'm, just going to ask us well.

The Mac expansion cohort, David I thought thats really exciting that you've actually completed enrollment and are now I guess that was mentioned at the conference as well.

That could be potentially pivotal can you talk about whether you would actually be able to announce data on that at some point. This year. Its pivotal do you want the whole thing to be done before you report out on it could you have piecemeal data and then maybe make a comment on the ship to combo as well. Thank you so much.

Peter H. Griffith: [inaudible] Additionally, cost of sales will increase in connection with our manufacturing agreement. As I mentioned previously, the revenues and profit share will be included in other revenue. Research and Development Expenses Will Increase As Our Pipeline Advances With Year-over-Year Increases

Yeah. Thanks, Mike Yeah, No. We're very pleased with the rapidity of enrollment in the <unk>.

Mick safety cohort as we noted we've moved beyond that to the expansion cohort, it's quite possible, we'll have data from that over the course of this year will depend on.

Just as the data come in and as we.

See those results in us.

Again, it's too early to speculate on whether this could be pivotal or not as I've mentioned the master protocol.

Peter H. Griffith: And SG&A will decline primarily due to changes in our commercial model, including an increased focus on digital efforts. Now, let me take a moment to explain an update we are making to our non-GAAP policy. Effective January 2021, our non-GAAP results will no longer include fair value adjustments to equity investments. These adjustments to equity investments have historically been recorded in other income and expenses and were positive in our 2020 non-GAAP results. This change will not apply to our strategic investment in Beijing, which is included in our non-GAAP results and is accounted for under the equity method of accounting.

From which these data are derived is essentially designed so that any given arm can be blown up into.

Pretty rigorous phase II trial, and depending on indication in line of therapy of course, we would make any sort of decisions regarding regulatory intent in that context, so more to come as those data unfold, but.

We're quite happy with what we're seeing in terms of enrollment.

And ship to.

I'm chip two is moving along I think biologically that is.

Very interesting combination and again potentially more to come over the course of the year on that combination as well.

Thank you.

Your next question is from Karen Flynn with Goldman Sachs.

Hi, Thanks for taking the questions maybe just a two part for me.

Maybe for Peter I was just wondering as you look out the sustainability of that 50% operating margin. How you think about some of the puts and takes and then any visibility into your Biosimilar franchise margins. There I know that's a question we get frequently and then.

Peter H. Griffith: The press release contains the pro forma 2020 results by quarter under our updated policy. We will also now use updated adjusted 2020 amounts that conform to this policy for comparison purposes going forward. Under our updated non-GAAP policy that I just explained, here's our guidance for other income and expenses. We anticipate non-GAAP other income and expense in the range of $1.3 to $1.5 billion. This 2021 guidance reflects incorporation of four quarters of Beijing's results versus three quarters in 2020, which are recorded on a one quarter lag.

Again, a higher level and maybe for Bob you mentioned protein degradation is an interesting platform on the forward that you guys are spending a lot of time building out.

Do you expect to do that all internally or is that an area where you can also look externally for opportunities. Thank you very much.

Alright. Thank you great question on the operating margin as you know we don't go out on a long term basis on that but you also know that we intend to continue to be a top performing biopharma firm. When you look at any number of financial metrics and importantly operating margin.

Do want to make sure.

That I mentioned and confirmed we will remain flexible and adaptable as attractive internal and our external investment opportunities arise we have the underlying objective to grow our volumes and after tax cash flow. So that's really important to us we are committed to lean on our permanent productivity commitments.

Peter H. Griffith: Recall that we only use the limited publicly available consensus estimates for Beijing in connection with our guidance and thus may experience additional variability depending on Beijing's actual results. Our basis in Beijing as of December 31, 2020, was approximately $2.9 billion. And this long-term investment is valued at approximately $6 billion today based upon the current U.S. market price, our non-GAF tax rate guidance is 13-14%, and we expect capital expenditures of approximately $900 million, including investments in additional manufacturing and other capacity to support our volume-driven growth strategy.

As I mentioned, we're investing in and working on Digitization and automation. So we will continue to exercise all of that muscle to make sure that we do remain a top performing biopharma firm in operating margin.

On the Biosimilars.

Fair question, we continue to see Biosimilars as an extremely strong allocation of capital for us.

The margins continue to be very competitive and we're very confident.

In terms of allocating capital to that category and we will continue to do that.

And we think we've got some strong expertise there I like to quote murdo.

Says that we've played a lot of defense in Biosimilars and now as we're on offense, we're able to have a <unk>.

Peter H. Griffith: As well as in environmental sustainability initiatives that will enable our global operations to achieve carbon neutrality by 2027. And also in our digitization efforts to continue to scale up and integrate data and analytics into everything we do at AMP. And finally, our capital allocation hierarchy remains unchanged. After both internal and external innovation, and then investing in our capital expenditures, we remain committed to returning capital to shareholders in the form of growing dividends, including the 10% increase in the first quarter of 2021 to $1.76 per share.

High quality of execution level.

Good questions in that and I'll flip it over to Bob.

Thanks for your question as I said in my remarks.

Other than calling it targeted protein degradation, we're describing it as our induced proximity platform.

Pension there is as I said, it's just too.

Be clear that we think the technology that we're building can be used not just us to create proteins, but other molecules as well. So we're excited about it.

And again in my remarks.

Long term research strategy, and David and his team and I.

A lot of time with each other I'm trying to think about how to position for the long term and in this area will be both internal and external I'd remind you that we acquired new evolution now two years ago for the purpose of helping to build out the set of capabilities.

And I would imagine we'll continue to look for as I said, both internally and externally David field.

Free to jump in and add two thoughts, yes, I think that covers it pretty well Bob.

I would say that we view this multi specificity and drugs as part of the future.

Peter H. Griffith: We anticipate opportunistic share repurchases in the range of $3 to $4 billion, subject to our board's authorization. In summary, we deliver for patients, every patient, every time, and for our investors in a challenging year that included the greatest public health crisis in 100 years and the greatest economic disruption since the Great Depression, and we are confident in the outlook for Amgen's success in 2021 and beyond.

Many of you know that 80% to 85% of the currently desirable targets are currently Undruggable. We think this is going to be a very important.

Technology, and making many of those targets tractable and as Bob mentioned, we are investing for the long haul we expect that to be a combination of both internal and external innovation.

Your next question is from Matthew Harrison with Morgan Stanley.

Great. Good afternoon. Thanks for taking the question Dave I was wondering if you could just comment a little bit more on the on the bite programs and some of the safety issues that have happened and just what's your confidence in those programs, especially as it seems to relate to some of these extended half life programs. Thanks.

Bob Bradway: This concludes the financial update. I will now turn the call back over to Bob. Okay, thank you, Peter. And Erica, let me invite you to remind our callers of our process for Q&A. And we will begin the question session. As a reminder, to ask a question, you will need to press star 1.

Yes, Thanks, Matt.

Thank you for this question I would say overall I feel very bullish on the bite program as we mentioned AMG 160, and AMG 757 are advancing quite rapidly.

Cytokine release syndrome is clearly the single challenge that.

Unknown Attendee: Hey guys, thanks for taking my questions.

Since before the entire field and we're making.

Unknown Attendee: Srinivasan. And congrats on always being a solid guide and a great quarter. I just wondered maybe if you guys could talk a little bit about, obviously, the K-Rest program and the combinations and maybe perhaps kind of, you know, they're probably early phase one studies, but, you know, what you're kind of looking to glean from some of these different combinations. I know you get asked a lot about this, but just kind of, as we're getting closer and closer, like, how do you think about Hi Leithian.

Adjustments in the 701 program to handle that I'm quite confident that we can come up with a.

Clinically important profile for that molecule or there are many be CMA molecules in development and of course, we'll shape our investments. According to whether we can really fulfill an unmet medical need.

I would say.

In closing that.

I am quite optimistic about the halfway of extended bite platform.

A few of the positives such as Ams G 673.

Our acute myelogenous leukemia.

John on purpose, because we selected the first generation molecule, which we are investigating in the minimal residual disease.

Unknown Attendee: Thanks for the question. Yeah, we do get this one quite a bit about the combinations. You know, what I will say is there's no generic answer here. It's going to depend on the line of therapy and indication, you know, non-small cell lung cancer, of course, but colorectal cancer and then some of the other indications beyond that. You know, typically, you're looking for, you know, 15, 20, 30 percent increment on any given endpoint beyond standard of care, but also looking at the totality of the data. I think in many of these settings, in particular, progression-free survival and ultimately overall survival. So, you know, given the safety profile we've demonstrated to date, you know, those are the sort of efficacy, Hi, thanks.

Heading.

Where that technology is well suited this was done in close concert with our investigators.

Many of these choices were part of our strategy, we anticipated making these choices.

As part of <unk>.

Prudent shaping of our portfolio going forward. So overall I feel quite good about where we are and how that platform is evolving.

Your next question is from Yaron Werber with Cowen.

Hi team.

Good afternoon, David.

<unk> for you if you don't mind.

Quick follow up on so tourists.

Can you give us a sense, obviously, it's encouraging that the MC combo, you were able to get the full dose of <unk> any comments on Keytruda ship to orbit talks and then until the pillow Mab the late breaker looks really good.

David on the steroid refractory was surprising and im not sure if it's potentially trial design differences from the other biologics.

Unknown Attendee: I'm looking at a lot of KRAS questions, so I'm just going to ask them as well.

Given how robust the responses otherwise would you consider repeating that study with a more similar trial design for the other ones. Thank you.

Unknown Attendee: as well. The MEC expansion cohort, David, I thought it was really exciting that you've actually completed enrollment, and I guess that was mentioned at the conference as well. That could be potentially pivotal. Can you talk about whether you would actually be able to announce data on that at some point this year? It's pivotal. Do you want the whole thing to be done before you report out on it?

Yes. Thanks for the question in regards to the combinations.

Ones you mentioned are all actively in dose escalation looking at either different doses or in some cases, even scheduling depending on the agent side. This is standard phase one b oncology drug development I feel good about how quickly we're moving and we will provide guidance as we expect those.

Data to emerge.

<unk> as you mentioned the abstract is out now we feel the data are very strong.

We feel more competitive with the best in the high eosinophil population and in many ways Standalone in the low eosinophil population. The steroid sparing study as you alluded. We think there were potentially trial design issues and we're going through that with our invest.

Unknown Attendee: Could you have piecemeal data? And then maybe make a comment on the SHIP-2 combo as well? Thank you so much.

Unknown Attendee: Thanks, Mike. Yeah, no. We're very pleased with the rapidity of enrollment in the MEC safety cohort. As we noted, we've moved beyond that to the expansion cohort. It's quite possible we'll have data from that over the course of this year, but it will depend on, you know, just as the data come in. And as we see those results, you know, and again, it's too early to speculate on whether this could be, you know, pivotal or not.

The Gators anticipate presenting those data a little later this spring and we're discussing with our partners whether.

A differently designed follow on study would be appropriate I would point out that that trial is not necessary for filing.

And we are moving ahead with all deliberate speed as we announce.

Global submissions of <unk> based on the current data.

Your next question is from Geoff Meacham with Bank of America.

Unknown Attendee: As I've mentioned, the master protocol, from which these data are derived, is essentially designed so that any given arm can be blown up into a pretty rigorous phase two trial. And depending on indication and line of therapy, of course, we would make any sort of decisions regarding regulatory intent in that context. So, you know, more to come as these data unfold, but we're quite happy with what we're seeing in terms of enrollment, and ShipQ on ship two is moving along. I think biologically, that is a very interesting combination. And again, potentially more to come over the course of the year on that combination as well.

Afternoon, guys. Thanks, so much for the question.

Peter I may have missed missed this but looking to 2021 revenue guidance can you speak at a higher level what contribution if any you assume.

From so tourists have been because it would probably amount for this year and are there any COVID-19 COVID-19 headwinds still factored in.

When you look at product sales or do you assume 2021 is a more normalized demand curve all year. Thank you.

Yes, Thanks for the question, Jeff and I'll invite Murdo here, just a moment to jump in on several in Tennessee.

And look we expect continued COVID-19 impacts throughout 2021.

Revenue potential recovery in the latter part of the year and just on the vaccination rollout as I mentioned that will be.

Unknown Attendee: Thank you. Your next question is from Terrence Flynn with, Hi, thanks for taking the questions. Maybe just a two part from me, for Peter. I was just wondering as you look out for the sustainability of that 50% operating margin, how you think about some of the puts and takes. Any visibility into your biosimilar franchise, the margins there? I know that's a question we get frequently. And then, again, a higher level one, maybe for Bob, you mentioned protein degradation. Nathaniel, Daniel Lundquist, David Reese, Arvind Sood, Yaron Werber, Salveen Richter, Parents, thank you. Great question on the off...

Closely monitoring that as you can imagine and with respect to Soto Anthony Let me, let me turn that over to Murdo.

Look it's very exciting time for us and we've been.

And a lot of money getting preparing the launches for those and so forth. So murdo.

Thanks, Peter and thanks for the question, Jeff Obviously, we're quite excited about Sutter asset then.

I want a couple then David and his team that has fast they've moved in developing this product and also just a number of regulatory submissions they've been able to affect in a very compressed timeframe. So we are we are optimistic and hopeful that we'll get a fairly quick review.

In multiple markets around the world and so we would expect solar asset to contribute to revenue, we don't give product specific guidance, but.

This is a very large.

Population of high unmet medical need there's not a lot of choice for these advanced non small cell lung cancer patients. So we do anticipate that there'll be a.

Unknown Attendee: We don't go out on a long-term basis on that, but you also know that, you know, we intend to continue to be a top-performing biopharmaceutical company. I do want to make sure that I mention and confirm that we will remain flexible and adaptable as attractive internal and or external investment opportunities arise. We have the underlined objective to grow our volumes and after-tax cash flows. So that's really important.

Potential market with a high need there the one caution that I'll put out is just that.

The actual percentage of advanced non small cell lung cancer patients that have a K Ras <unk> status result in their file and their medical record right now we ascertain that to be at about 50%. So we've got work to do to grow that number and obviously, we've seen with other targeted therapies. When you have an actionable mutation.

Unknown Attendee: We are committed to leaning on our permanent productivity commitment. As I mentioned, we're investing in and working on digitization and automation. So we'll continue to exercise all that muscle to make sure that we do remain a top-performing biopharmaceutical firm and operating. On biosimilars, that's a fair question. We continue to see biosimilars as an extremely strong allocation of capital for us, and the margins continue to be very competitive

The testing rate rises fairly rapidly. So we would expect upon approval to be able to do that but.

But nonetheless, we think so.

<unk> will be a meaningful contribution to at lease revenue in the US and then <unk>, we will we will see what the regulatory authorities.

Due with the filing obviously given that we had breakthrough designation and obviously given the the pen eosinophilic results that we've seen and now you guys can see the breakdown in that in the abstract. We think this is an important medicine to get to market very quickly.

Unknown Attendee: We're very confident. Nathaniel, Daniel Lundquist, David Reese, Arvind Sood, Yaron Werber, Salveen Richter, David Reese, Arvind Sood, Yaron Werber, Justin Murray, Vikram Karnani, David Reese says that we've played a lot of defense in biosimilars, and now as we're on offense So, good questions on that, and I'll flip it over to, I think, Bob. But, Terence, thanks for your question.

The last question you asked about Covid impact Jeff was just I think we actually anticipate COVID-19 will have a fairly significant impact on the market.

Through the better part of <unk>.

The year beyond the mid point of the year.

I hope were wrong and I hope that vaccination programs will improve but right now we think that COVID-19 will be with us for the majority of 2021.

Okay. Thanks, guys.

Your next question is from Evan <unk> with credit Suisse.

Hey, guys. Thank you so much for taking the question. So I wanted to ask one on business development and capital allocation priorities. So it seems that theres a growing need for more mid stage assets, noting several pipeline pause as reported in this quarter with 80% of free cash flow is going to dividends and repurchases. How do you think about bringing in larger scale assets.

Unknown Attendee: As I said in my remarks, rather than calling it targeted protein degradation, we're describing it as our induced proximity platform. And the intention there, as I said, is just to... We're excited about it. This is a long-term research strategy, and Dave and his team and I spent a lot of time with each other trying to think about how to position ourselves for the long term. In this area, it will be both internal and external.

And would you lever up beyond your current.

Leverage levels, if there was an attractive opportunity.

I think we've been pretty consistent in saying that our focus is on investing in the business.

We said in our prepared remarks, we are planning to increase our investment in R&D. This year. So.

Unknown Attendee: I'd remind you that we acquired New Evolution now two years ago for the purpose of helping to build out this set of capabilities. I would imagine we'll continue to look, as I said, both internally and externally.

Spending internally to continue to allocate capital.

R&D opportunities, we'll continue to look externally.

Look at smaller and larger opportunities.

<unk>.

<unk> business development.

We are very active in the <unk>.

Bob Bradway: Dave

Areas, where we have demonstrated expertise therapeutically.

David M. Reese: Yeah, I think that covers it pretty well, Bob. You know, I would say that we view this multi-specificity in drugs as part of the future. Many of you know that 80 to 85 percent of the currently desirable targets are currently undruggable. We think this is going to be a very important technology in making many of those targets tractable. And as Bob mentioned, we are investing for the long haul. We expect that to be a combination of both internal and external innovation from Amman. Great, good afternoon, thanks for taking the question. Dave, I was wondering if you could just comment a little bit more on

That's what our focus is very likely.

A tale.

Yes.

Opportunities that fit well with areas that we have demonstrated expertise.

The balance sheet, rather than engage in a hypothetical.

We maintain a strong balance sheet, so that we have strategic flexibility.

And we.

We will consider individual opportunities as they arise.

Alright, Thank you for the color I appreciate it.

Your next question is from Dane Leone with Raymond James.

Alright, Thank you for taking the questions congratulations on the update and outlook for 2021.

So the question for me it focuses a bit on <unk>, but there's a little bit different than what's been discussed previously.

Allergy.

Asthma, specifically in this case.

It would be a new vertical for Amgen, how are you thinking about building out that vertical.

Unknown Attendee: Jyothi Kulkarni, Aniruddha Mukherjee, Aniruddha Mukherjee, Aniruddha Mukherjee

Around expected commercial launch of <unk>, but also thinking about other indications or assets behind that internally or externally.

David M. Reese: [inaudible] Yeah, thanks, Matt. Thank you for this question. I would say overall, I feel very bullish on the BITE program. As we mentioned, AMG 160 and AMG 757 are advancing quite rapidly. You know, cytokine release syndrome is clearly the single challenge that sits before the entire field, and we're making adjustments in the 701 program to handle that. I'm quite confident that we can come up with a, you know, clinically important profile for that molecule. There are many BCMA molecules in development, and we will shape our investments according to whether we can really fulfill an unmet medical need.

That you could point to.

To make it more of a broader vertical going forward.

Same vein.

Maybe touch a little bit more on oncology.

Obviously in the solid tumor space Hasnt been an area that <unk> been heavily invested and.

Historically, but obviously with the tourists approval coming in the first half this year.

You are kind of arresting on the bi program behind that are there other assets outside of the <unk> program.

You could highlight internally that might expand your presence there and or.

Should we be thinking about something more differentiated that you might do externally.

Around the solid tumor space. Thank you.

There's a lot there day in and your question Murdo and I'll, just double team, but very quickly let me remind you what we.

David M. Reese: I would say in, you know, in closing that I'm quite optimistic about the Half-Life Extended BITE platform. You know, a few of the positives, such as AMG 673 for acute myelogenous leukemia, were done on purpose because we selected the first-generation molecule, which we are investigating in a minimal residual disease setting where that technology is well-suited. This was done in close concert with our investigators. Many of these choices were part of our strategy. We anticipated making these choices as part of, you know, prudent shaping of our portfolio going forward. So, overall, I feel quite good about where we are and how that platform has evolved. Hi team, good afternoon.

We pointed out when we entered into a partnership with Astrazeneca in particular.

On the respiratory opportunity, which.

Which was that you pointed out it is a new area for US we felt that we could deliver more for our shareholders and for patients by collaborating with us.

Groups that have demonstrated expertise in respiratory medicine, and so we chose to partner with us.

We're pleased with that collaboration and look forward to taking the molecule to market with them.

And I would just point out that.

We came to us through our commitment to anti inflammation.

In decades.

Decades of experience.

Biology of information that we've been able to capitalize on this program and hopefully others over time.

But murdo jump in and in particular share your thoughts also on the solid tumor.

Yes sure. Thanks, Bob we are building out our teams as we speak.

And Amgen will help commercialized as Italian mob in the Americas region. So U S and Canada, we will be focused on an allergist, while astrazeneca will play a broader role beyond just allergists, including.

Unknown Attendee: David, I have a question for you, if you don't mind, and a quick follow-up. On Satorisib, can you give us a sense of, obviously, it's encouraging that with the MEK combo, you were able to get the full dose of Satorisib. Any comments on Keytruda, SHIP2, or Erbitux?

John.

The respiratory specialty so.

This is as you mentioned, it's a new area, but it's not that different from what we've done as Bob mentioned and other inflammatory disease processes. The other thing that's worth mentioning is we will be taking a leading role in.

David M. Reese: And then on Tezapelumab, the late breaker looks really good. The data on the steroid refractory was surprising, and I'm not sure if it's potentially trial-designed differences from the other biologics, just given how robust the response is otherwise. Would you consider repeating that study with a more similar trial design to the other ones? Thank you. Yeah, thanks for the questions.

Establishing access for Tessa Italian that with payers and again, our extensive biologics contracting experience in part D and the government programs will help us secure broad access for Tessa value for a broad range of patients.

As you saw we have a nice product profile here that will benefit a lot of patients regardless of their iOS and affiliate status.

David M. Reese: You know, in regards to the combinations, the ones you mentioned are all actively in dose escalation, looking at either different doses or, in some cases, even scheduling, depending on the agents. This is standard phase 1b oncology drug development, and I feel good about how quickly we're moving. And, you know, we'll provide guidance as we expect those data to emerge. For tezapelumab, as you mentioned, the abstract is out now, and we feel the data are very strong. You know, we feel we're competitive with the best in the high eosinophil population and, in many ways, stand alone in the low eosinophil population.

And then Dave Reese his team is obviously building our medical capabilities for the same customer facing group.

So we're excited about it's a focused effort.

The beauty of focusing on allergists as they're very productive.

Prescribers, but theyre a relatively small audience size, so we will be quite focused and addressing that.

When it comes to.

Kind of how we're <unk>.

Looking at our oncology portfolio, we've got a very strong base right now that oncology between our hematology business are solid tumor therapeutics, we have now are.

Overall, biosimilar portfolio and our supportive care.

Basically one five oncology patients today receive an amgen therapy, and so bringing solar assets into that mix.

David M. Reese: The steroid sparing study, as you alluded to, we think there were potentially trial design issues. And, you know, we're going through that with our investigators, and we anticipate presenting those data a little later this spring. And we're discussing with our partners whether a differently designed follow-on study would be appropriate. I would point out that that trial is not necessary for filing.

And then the potential of AMG $160 and $75 seven and 701 I think is a fairly action packed next few years in oncology that we can build on the current strength that we have and we're excited about that.

I'm always asking Dave Reese to deliver more and his team have a lot of other earlier assets to put into the clinic I'll turn it over to day for day shutdown that exactly.

Unknown Attendee: And we are moving ahead with all deliberate speed, as we announced with global submissions of tezapelumab based on the current data. Afternoon, guys. Thanks.

Exactly we have got a couple of gastric cancer by ex of course also a solid tumor indication and we've got some other molecules in late preclinical or just entering the clinic that will target solid tumor indications more on those.

Unknown Attendee: Thanks so much.

Unknown Attendee: Peter, I may have missed this, but looking at the 2021 revenue guidance, can you speak at a higher level about what contribution, if any, you assume from Sotoriceb and Tezepelima for this year, and are there any COVID headwinds still factored in when you look at product sales, or do you assume 2021 is a more normalized demand curve all year? Thank you.

Speak about them going along so I think it's going to be quite a broad portfolio.

Still up quite a few people in the line. So just a request if you can please limit yourself to one question Eric how that's probably the next question.

Our next question is from Robin Cornwell Smith with <unk> Securities.

Hi, Hi.

Hi, Thanks for taking my question.

I have a question for Murdo I was just looking at them, Nevada strength on that.

Peter H. Griffith: Thanks for the question, Geoff, and I'll invite Murdo here in just a moment to jump in on Soto and Tezi. And, look, we expect continued COVID impacts throughout 2021. Ravid, Potential recovery in the latter part of the year contingent on the vaccination rollout, as I mentioned. We'll be closely monitoring that, as you can imagine. And with respect to Soto and Tezi, let me turn that over to Murdo. And look, it's a very exciting time for us. You've invested a lot of money preparing the launches for those and so forth, so Murdo?

That Kent Ginty decline in Neulasta price decline with significant putting all of these trends together can you just help us think now what you think of how to model the tail.

For Biosimilars and if there's differences between some of your oncology drugs like the strength in the lawsuit is really impressive versus the decline of Neulasta just to get a sense of how we should think about that and help us model that thank you.

Yeah.

Thanks for the question Robyn.

As we look at 2021, I would say that the majority of our growth will come from additional international launches of our Biosimilar portfolio and obviously, some additional revenue from that Sola and Ray Abney two relatively reese.

Murdo Gordon: Thanks, Peter. And thanks for the question, Geoff. Obviously, we're quite excited about SodaRacib. And, you know, I want to compliment Dave and his team on how fast they've moved in developing this product and also just the number of regulatory submissions they've been able to make in a very compressed timeframe. So we are optimistic and hopeful that we'll get a fairly quick review in multiple markets around the world, and so we would expect SodaRacib to contribute to revenue. We don't give product-specific guidance. But, you know, this is a very large population with high unmet medical need. There's not a lot of choice for these advanced non-small cell lung cancer patients.

Our recent biosimilar launches in the U S.

Specifically, if you think about <unk> and <unk>, they are a little bit different.

And the differences are twofold, theres more than that but let's stick to the two major ones bevacizumab as a molecule is actually growing.

Whereas trastuzumab as a molecule is is flat to declining so.

One thing that we're seeing in <unk> is actually the number of cycles of Bevacizumab overall is growing and so even holding share in that molecule actually holds up quite well. We also have less competition. That's the other factor.

So theres less competition for now in the Bevacizumab.

Murdo Gordon: So we do anticipate that there'll be a potential market with a high need there. The one caution that I'll put out is just the actual percentage of advanced non-small cell lung cancer patients that have a KRAS G12C status result in their file, in their medical record. Right now, we ascertain that to be at about 50%. So we've got work to do to grow that number. And obviously, as we've seen with other targeted therapies, when you have an actionable mutation, the testing rate rises fairly rapidly. So we would expect, upon approval, to be able to do that.

Molecule, whereas with Trastuzumab, we have more competitors and so I think going forward you would see competitive dynamics shaping those two brands a little bit differently.

Your next question is from Mohit bansal with taking place.

Great. Thanks for taking my question and congrats on all the progress maybe one question on the balance sheet.

Seems like you had been able to go with this product.

And what gets us moving well.

And this has been a difficult market.

Got it so.

So could you please help us by the group in terms of whether youre, taking share from existing antibiotics on the expanding the market.

And then do you expect any chatter than that from the media comes to market.

This product thank you.

Yes, I was picking up a little bit of static. So I think the question is on <unk> entity.

The first part of the question I understood was how are we sourcing or the entity growth is it from existing anabolic patients. So are we expanding and treating new patients I didn't catch the second part of the question, but let me address the first part overall, we're pleased with other than it is evolved.

Murdo Gordon: But nonetheless, we think SodaRacib will make a meaningful contribution to at least revenue in the U.S. And then TESI, we'll see what the regulatory authorities do with the filing, obviously, given that we had breakthrough designation. And obviously, given the pan-eosinophilic results that we've seen, and now you guys can see the breakdown and that in the abstract, we think this is an important medicine to get to market The last question you asked about COVID's impact, Geoff, was just, I think we actually anticipate COVID will have a fairly significant impact on the market through the better part of the year beyond the midpoint of the year. I hope we're wrong. And I hope that vaccination programs will improve. But right now, we think that COVID will be with us for the majority of 2021.

We've got nice evolution in our Japan business.

And Japan is obviously, we've been in the market a little bit longer. So one thing that we're seeing with <unk> patients are on the product for a 12 month duration of treatment and so you have to replenish those new patients you do have to source those new patients and so I think the team in Japan is quite experienced now at sourcing new patients and not necessarily where we are.

Got our early growth was from which was switching from other anabolic.

And there are unfortunately, there are a lot of aging patients in these markets, where osteoporosis goes unchecked and patients suffer fractures in these high risk patients need us.

Solid bone builder.

<unk> entity to be able to improve their clinical outcomes. So I think in Japan, we're sourcing more de novo growth than we were perhaps six to 12 months ago, whereas in the US is much more of a mix of de Novo and switch.

Unknown Attendee: Okay, thanks guys. Your next question is from Evan Seigerman, with, Hey guys, thank you so much for taking the question.

Unknown Attendee: So I want to ask one on business development capital allocation priorities. So it seems that there is a growing need for more mid-stage assets, noting several pipeline pauses reported in this quarter, with 80% of free cash flows going to dividends and repurchases. How do you think about, you know, bringing in larger-scale assets?

The other thing Thats, helping us in the US is of course, having both prolia and <unk> entity.

For the customer a lot of the time when a patient will come in and have a fracture. Despite their prolia treatment. There are really good candidate for us entity. So we're often getting patients on both treatments and sometimes after the 12 months.

Other than any treatment are up they will roll back onto Prolia. So it's a nice franchise to have and have both.

Unknown Attendee: And would you lever up beyond your current leverage levels if there was an attractive opportunity?

An anti reserved Havana bone building agent.

For our customers. So I think the future growth looks very good obviously our partners at UCB are just getting going in Europe.

Unknown Attendee: Evan, I think we've been pretty consistent in saying that our focus is on investing in the business, so as we said in our prepared remarks, we're planning to increase our investment in R&D this year, so committing internally to continue to allocate capital to R&D opportunities. We'll continue to look externally.

As they established reimbursement for the product, but I'm quite excited about what if entity could become for these.

Bone building for these very high risk post fracture patients.

Your next question is from Omar <unk> with Evercore ISI.

Hi, Thanks for taking my question I'll take the one Murdo you recently mentioned 25000 as the target population for kiosks and that sounded for other high to me at least for US. So I was curious whether that was for us only a worldwide and the if you were assuming a around 14% prevalence rate for <unk>.

Unknown Attendee: We'll look at small and larger opportunities like licensing and business development. We're very active in the areas where we have demonstrated expertise therapeutically, and that's what our focus is very likely to be. Opportunities that sit well with the areas that we have demonstrated expertise in. In terms of the balance sheet, you know, rather than engage in hypotheticals, we maintain a strong balance sheet so that we have strategic flexibility. And, you know, we'll consider individual opportunities as they arise.

LC and whether you were doing this analysis on non squamous only for this math. Thank you so much.

Yes, thanks for the question over the.

25000 was a U S number we actually estimate the non small cell lung cancer incidence globally at 120000 patients now obviously there is some reduction from first line to second line lung cancer, because unfortunately, we lose patients in frontline the second line and beyond is obviously our target population.

Unknown Attendee: All right. Thank you for the call. I appreciate it.

Unknown Attendee: Your next question is from Dane Leone with Raymond. Thank you for taking the questions.

Unknown Attendee: Srinivas Jain, Anirudh Singh, Anirudh Singh, Anirudh Singh, Anirudh Singh, Anirudh Singh,

At launch and we assume that 13% incidence of <unk>.

Unknown Attendee: [inaudible]

Unknown Attendee: would be a new vertical for Amgen. How are you thinking about

In the broad non small cell lung cancer patient population.

Unknown Attendee: Abhishek Thakur, Anirudh Thakur, Anirudh Thakur, Anirudh Thakur

Right. So murdo, if we just go down that track, 13% and 120 K I was just confused the 25 K.

Unknown Attendee: [inaudible] Maybe touch a little bit more on oncology.

Unknown Attendee: Obviously, the solid tumor space hasn't been an area that you've been heavily invested in historically, but obviously, it was the Toraceb approval company in the first half of this year. You're kind of resting on the BITE program behind that. Are there other assets outside of the BITE program that you could highlight internally that might expand your presence there?

Yes, so that's the US only number for incidence of non small cell lung cancer that had progressed into second line and beyond.

Okay.

You very much.

Thanks.

Your next question is from Kennan Mackay with RBC capital markets.

Hi, Thanks for taking the question and it's wonderful to speak with everyone.

Soon after the Friday Night conference call. Thanks for doing this.

Maybe for Dave maybe it's the bites that you spoke to previously but I always love asking this question within the early stage phase one or.

Unknown Attendee: Nair, and or should we be thinking about something more differentiated?

Unknown Attendee: [inaudible]

States do pipeline what are you most excited about in 2021 whats going to be the next door. Thank you.

Bob Bradway: Thank you. There's a lot there, Dane, in your question.

Murdo Gordon: Murdo and I will just double team. But very quickly, let me remind you what we were thinking, which was that, you know, this, as you point out, is a new area for us. We felt that we could deliver more for our shareholders and more for patients by collaborating with a group that had demonstrated expertise in respiratory medicine. And so we chose to partner with AstraZeneca. And we're pleased with that collaboration and look forward to taking the molecule to market with them.

Yes, Thanks, and I think we were able to just rejoined in time for that question.

Again, I can hear us.

I think in terms of the.

Early pipeline AMG 160, and AMG 757, as I highlighted in my prepared remarks are ones that were really looking at 160 <unk> advanced into the expansion cohort and if we continue to generate data as we have recently.

Through a larger number of patients that's a program that we would.

Probably be discussing potential registration paths sooner rather than later I think AMG 757 is just one step behind us.

Murdo Gordon: And I would just point out that, you know, we came to this through our commitment to anti-inflammation, and have decades of experience in the biology of information that we've been able to capitalize on Murdo, jump in, and in particular share your thoughts also on the solid tumor question.

That's another one that we're keeping a very close eye on and then in our inflammation portfolio, we've got a variety of.

These two assets in autoimmune indications as we've previously indicated and those programs are ones that I'm quite interested in as we move forward. So thanks for the question.

Your next question is from Geoffrey Porges with SBB Leerink.

Bob Bradway: Yeah, sure. Thanks, Bob.

Murdo Gordon: We are building out our teams as we speak, and Amgen will help commercialize tezapelimab in the Americas region, so the US and Canada. We will be focused on allergists, while AstraZeneca will play a broader role beyond just allergists, including respiratory. So this is, as you mentioned, a new area, but it's not that different from what we've done, as Bob mentioned, in other inflammatory disease processes.

Very much I appreciate the question.

Got a question about about your commercial model you mentioned in the prepared remarks, a couple of times that you are shifting.

More of a digital approach.

Just wondering we've heard that there have been significant reductions in your commercial field organizations can you give us a sense of what the magnitude of the efficiency and head count Youre seeing on your average sales force by moving towards digital.

Could you talk about how you think that might play out in a post COVID-19 world wouldn't you expect to have to ramp back up once we eliminate.

Murdo Gordon: The other thing that's worth mentioning is we'll be taking a leading role in establishing access to tezapelimab with payers, and again, our extensive biologics contracting experience in Part D and government programs will help us secure broad access to tezapelimab for a broad range of patients. As you saw, we have a nice product profile here that will benefit a lot of patients, regardless of their And then Dave Reese's team is obviously building out medical capabilities for the same customer-facing group, so we're excited about that. It's a focused effort. The beauty of focusing on allergists is that they're very productive prescribers, but they're a relatively small audience size.

Eliminate social distancing.

Thanks, Geoffrey for the question there are a couple of factors that went into our.

The recent reorganization of our field force one is just portfolio evolution.

Creating capacity for the new.

Launches and then reallocating from the older side of the portfolio and depending on which region you were talking about in the world with Amgen. We're in very different stages of development. So for example, we're placing large investments in field force in Japan and in China.

Even in Russia, and some other markets that are emerging for us as being important growth drivers and in the U S.

We're really paying close attention to the forces in the market beyond Covid, we're looking at potential negative net price effects and ore price reform as Bob mentioned in his opening remarks as being a bit of a prevailing wind here and so what we're doing us looking at our overall commercial model and to Europe.

Murdo Gordon: So we'll be quite focused on addressing that. When it comes to, you know, kind of how we're looking at our oncology portfolio, we've got a very strong base right now in oncology between our hematology business, our solid tumor therapeutics that we have now, our overall biosimilar portfolio, and our supportive care. Basically, one in five oncology patients today receives an Amgen therapy. And so bringing Sotiracib into that mix, and then the potential of AMG-160 and 757 and 701, I think it is a fairly action-packed next few years in oncology that we can build on the current strength that we have, and we're excited about that.

Your point, making it more productive and making it more efficient.

So we're.

We're largely on track with that.

That plan, we were able to move very rapidly last year and build out our digital capabilities to an even greater extent than we had historically.

We are seeing customers willing to engage in those channels and we think some of those engagements will be persistent beyond COVID-19 quite frankly, and it's that persistency that we're betting on what we haven't done is compromised the ability to have competitive share of voice in our field facing interactions both on the medical side both on the commercial.

Site in front of the customer.

Murdo Gordon: I'm always asking Dave Reese to deliver more, and I know his team has a lot of other earlier assets to put into the clinic. I'll turn it over to Dave for additional comments. Exactly. We've got a couple gastric cancer bites, of course, also a solid tumor indication. We've got some other molecules in late preclinical stage.

So we think we will continue to be able to compete effectively in the categories. We're in as well as augment that with highly efficient digital channels of communication.

Thanks very much.

Eric and I know, we're approaching the top of the hour and some of our callers might need to drop off but the.

Management teams available I know, we still have several questions in the queue. So for those who have questions that you'd like to ask will go beyond the top of the hour.

I apologize to those of you who have other plants that need to drop off here.

Here in two minutes.

Eric if you can take us to the next caller.

Yes. Our next question is from Carter Gould with Barclays.

David M. Reese: We're just entering the clinic that will target solid tumor indications; more on those as we're ready to speak about them going along. So I think it's going to be quite a broad portfolio.

Thanks, guys and congrats on this other asset day to day impressive execution, I guess, murdo and Bob coming back to Tesla at the time of the acquisition.

You guys seem to other oriented us that the majority of the growth would come from the us and yet I guess your comments today seem to be teeing up really I guess, the global nature of the growth going forward I guess, just your level of confidence around Oh Tesla growth in the us through the mid 2025 timeframe I guess given the competition in.

David M. Reese: We still have quite a few people on the line, so just a request if you can please limit yourself to one question. Erika, let's go to the next question. Your next question is from Robyn Karnauskas. Erika, are you there?

What have you. Thank you.

Maybe I'll just take the first two and then Murdo you can augment however, you'd like but what I'd say is that when we acquired it. We said we felt we could achieve double digit growth.

Through the first several years of ownership and we continue to feel confident in that.

Unknown Attendee: Thank you. Thank you. Thank you.

And that's a function of both potential for increased label.

Murdo Gordon: Hi, thanks for taking my question. So I have a question for Murdo. I was just looking at the Mavasi strengths, Jinty declined, and the Nu'elasta price decline was significant; putting all these trends together, can you just help us think now about how to model the tail for biosimilars, and if there are differences between some of your oncology drugs, like the strength of Mimosa is really impressive versus the decline of Nu'elasta, just get a sense of how we should think about Thank you.

Arrange in the us as well.

Turning to the launch of international markets, but murdo.

Maybe you want to elaborate on the opportunity that mild moderate.

Sure.

Yeah. Thanks, Bob.

We do we do see some of the international expansion maturing now we've got a good business for Tesla in Japan.

We're pursuing registration in China, and we recently secured reimbursement in Australia.

So we're evolving the global footprint of a Tesla beyond where the legacy Celgene effort has had it.

So that is one source of growth, but as Bob mentioned, we're also pursuing in the U S mild to moderate approval on the basis of the positive data set we have there and that will that will allow us to move or Tesla into a patient population that really is still an unmet need these are patients who have.

Murdo Gordon: Thanks for the question, Robyn. As we look at 2021, I would say that the majority of our growth will come from additional international launches of our biosimilar portfolio and, obviously, some additional revenue from Avsola and Reabni to relatively recent biosimilar launches in the US. Specifically, if you think about Embasi and Kangenti, they are a little bit different, and the differences are twofold. There's more than that, but let's stick to the two major ones.

Skin surface area that they might be seeking.

On alternative too messy and inconvenient topical agents and I think Tesla can play a very important role there and helping treat those patients were also in making investments in hotels led by expanding the promotional footprint of the product to include primary care promotion something that Celgene had not done historic.

Murdo Gordon: Bevacizumab as a molecule is actually growing, whereas Trastuzumab as a molecule is flat to declining. So one thing that we're seeing in Embasi is actually the number of cycles of Bevacizumab overall growing. And so even holding a share in that molecule actually holds up quite well. We also have less competition, that's the other factor. So there's less competition for now in the Bevacizumab molecule, whereas with Trastuzumab we have more competitors. And so I think going forward, you will see competitive dynamics shaping those two brands a little bit differently.

So we're doing that both for the moderate to severe patient, but as well for that mild to moderate indication in anticipation of that.

Potential approval.

And then the only other thing I would say is.

While we are seeing a little bit of softness in psoriasis and broader rheumatology.

For the category due to Covid, Oh, Tesla being an oral has held up quite well and the execution has been strong I also think that the.

Stablish safety and efficacy profile of Oh Tesla is highly appreciated given recent news.

Murdo Gordon: Jay, thanks for taking my question and congrats on all the progress. Maybe one question on the vanity.

In the broader rheumatology category of other oracle's, where perhaps that that risk benefit equation is different than it is.

Unknown Attendee: It seems like you have been able to grow this product, not just in the US, but globally as well. And this has been a difficult market historically. So could you please help us characterize this growth in terms of whether you are taking shares from existing anabolics or are you expanding the market? And then do you expect any challenge when the pads from the US come to market for this product?

Where it is very strong with Oh Tesla. So we think we've got a good opportunity for growth. We also said when we gave that guidance that assumed a successful.

Competitive program from.

They take two asset and of course that was confirmed today.

Your next question is from Jay Olson with Oppenheimer.

Murdo Gordon: Thank you.

Oh, Hey, congrats on all the progress and thank you for taking the question. Since you received breakthrough therapy designation source of tourists have been China can you comment on how fast you consume it us filing and gain regulatory approval and what percentage of Asian, non small cell lung cancer patients have <unk>.

Murdo Gordon: Yeah, I was picking up a little bit of static. So I think the questions on event ID, the first part of the question I understood was, how are we sourcing our event ID growth? Is it from existing anabolic patients? Or are we expanding and treating new patients? I didn't catch the second part of the question, but let me address the first part.

Mutation and how large that commercial opportunities for us the tours have been China. Thank you.

Thanks Jay.

We're very pleased to get breakthrough therapy designation in China as our filing.

Murdo Gordon: Overall, we're pleased with how event ID has evolved. We've got a nice evolution in our Japan business. In Japan, it's all obviously obvious that we've been in the market a little bit longer.

Plans to move forward with our colleagues at Beijing will provide guidance about what those timelines might look like guide us a little bit different implications in China, then it does potentially.

Murdo Gordon: So one thing that we're seeing with event ID is patients are on the product for a 12 month duration of treatment, and so you have to replenish those new patients; you do have to source those new patients. And so I think the team in Japan is quite experienced now at sourcing new patients and not necessarily where we got our early growth, which was switching from other anabolics. You know, and unfortunately, there are a lot of aging patients in these markets where osteoporosis goes unchecked, and patients suffer fractures, and these high-risk patients need a solid bone builder like event ID to be able to improve their clinical outcomes. So I think in Japan, we're now sourcing more de novo growth than we were perhaps six to 12 months ago, whereas in the US, it's much more of a mix of de novo and switch.

In the United States and then one thing that we're looking at quite carefully as the epidemiology of G <unk> mutations.

There is a suggestion that it may be a little lower and prevalence in Asian populations, probably because they are mutually exclusive with mutations in egfr, which are quite high in these populations up to 40%.

In.

China and Japan for example, so that'll be an important question.

We address we've got active research collaborations now looking at just that and Murdo I don't know if you want to add anything.

About the commercial side in China.

Yeah.

Yes, I think we're obviously very excited about what we can do with the product huge unmet medical need we're seeing that China is an attractive market for specialty products and the fact that.

<unk> is an oral makes it very accessible so we will pursue.

Commercialization of <unk> in China, and our affiliate.

Murdo Gordon: The other thing that's helping us in the US is, of course, having both prolia and event ID for the customer. A lot of the time when a patient will come in and have a fracture, despite their prolia treatment, they're a really good candidate for event ID. So we're often getting patients on both treatments, and sometimes after the 12 months of event ID treatment are up, they'll roll back on to prolia. So it's a nice franchise to have and have both an anti-resorptive and a bone building agent for our customers.

<unk> is very excited about that.

Great. Thank you.

Your next question is from Colin Bristow with UBS.

Hey, Thanks for taking the question.

Obviously, you're seeing the abstract data participating map the less the 150.

Pretty impressive I was just curious what your level of conferences and getting a broad label.

Didn't test for statistical significance.

Is that something that you've discussed with the FDA previously.

Murdo Gordon: So I think, you know, future growth looks very good. Obviously, our partners at UCB are just getting going in Europe as they establish reimbursement for the product, but I'm quite excited about what event ID could become for these for bone building for these very high-risk post-fracture patients.

I don't keep us shortly.

Yes. Thank you Paul this is a question we get frequently.

We demonstrated efficacy across a broad range of patients regardless of eosinophil count I think that's what clinicians will pay attention to.

We will provide guidance as regulatory discussions proceed I think it's too early.

Course prior to submitting to debate what a potential label would look like but our view is that overall. These are very very strong data pointing to a differentiated project product.

Unknown Attendee: from Umer Raffat with Evercore Eye Hi, thanks for taking my question. I'll stick to one. Murdo, you recently mentioned 25,000 as the target population for KRAS.

And I think this is just going to be a really important medicine for patients with severe uncontrolled asthma.

Murdo Gordon: And that sounded rather high to me, at least for the U.S. So I was curious, A, whether that was for the U.S. only or worldwide, and B, if you were assuming a around 14% prevalence rate for G12c, and whether you were doing this analysis on non-SQUAMES only for this mass.

Great. Thanks.

Your next question is from Ronny Gal with Bernstein.

Thank you for squeezing me in here just.

Biosimilars are you spoke a.

A little bit talking about increased competition pressure.

Is the is it sufficiently in 2021, the kind of the price decrease in oncology will exit that 10% to 15%.

Murdo Gordon: This announcement is on non-SQUAMS only for this mass. Thank you so much.

Decline rate is there any reason to expect that the players coming in and making changes.

Murdo Gordon: Thanks for the question, Umer. The 25,000 was a U.S. number. We actually estimate the non-small cell lung cancer incidence globally at 120,000 patients. Now, obviously, there's some reduction from first line to second line in lung cancer because, unfortunately, we lose patients in the front line. The second line and beyond is obviously our target population at launch, and we assume a 13% incidence of KRAS G12C in the broad non-small cell lung cancer patient population.

Or is this just an issue.

So the market is going to be hard to get 100%.

Yeah, Ronny I think.

You definitely see a diminishing.

Ray to return our gain in terms of volume share you see that in the shape of our uptake curves for both our oncology biosimilars in the U S.

I think that.

The way of course these products are used they are largely used in the community setting about 80% of the usage of both Bevacizumab and trust us in labs in our community oncology setting.

Those businesses tend to contract on a network by network basis.

By now most of those contracts are set in motion there is still some incremental opportunity to to add too.

Murdo Gordon: Right, so Murdo, if we just go down that track...

To our overall revenue base, but.

Murdo Gordon: 13% and

Murdo Gordon: I was just confused with the 25K.

Yes, I think the gains on volume will be incremental and then price trends as I mentioned in my scripted remarks.

Murdo Gordon: [inaudible]

Murdo Gordon: Yes, so that's the US only number for incidents of non-small cell lung cancer that have progressed into second line and beyond.

We will continue to evolve the way we've seen them.

Okay. Thank you.

Your next question is from Michael Schmidt with Guggenheim Securities.

Murdo Gordon: Your next question is from Kenan McKay with RBC Capital. Hi, thanks for taking the question. And it's wonderful to speak with everyone so soon after the Friday night conference call. Maybe for Dave, maybe it's the bytes that you spoke to previously.

Hey, guys good afternoon.

None of us interesting to hear about some of the early stage R&D efforts and the comments that remained around day induced proximity platform.

Along those lines I was wondering if you could provide.

Bit more insight into progress that may have been made within your human genetics admission to us and when or how it. This initiative may translate into new pipeline product. Thanks, so much.

Unknown Attendee: But I always love asking this question within the early stage phase one or stage two pipeline: What are you most excited about in 2021? What's going to be the next fedora set? Yeah, thanks. And I think we were able to just rejoin in time for that question.

Yes, Thanks, Michael.

Human genetics.

As Bob mentioned and as we've previously announced we have collaborations with Intermountain, how thought and UK biobank will add up to 1 million participants. We think will have the largest database on earth as these projects move towards completion.

David M. Reese: You know, again, I can hear you. I think in terms of the Early Pipeline, AMG 160 and AMG 757, as I highlighted in my prepared remarks, are ones that we're really looking at. 160 patients have advanced into the expansion cohort, and if we continue to generate data, as we have recently, through a larger number of patients, that's a program that we would, you know, probably be discussing potential registration paths sooner rather than later.

And we have broadened our focus on human data to include other ohmic technologies, such as transcriptome mix in proteomics.

And the belief in the long term.

It will be human data such as fees that are most important for drug discovery and development.

Current time, a majority of our non oncology portfolio.

Have genetic support that's either primary or secondary and we expect over time that that percentage will simply increase because there is no clear evidence that targets for which there is genetic validation programs based on them have a higher rate of success so more to come.

David M. Reese: I think AMG 757 is just one step behind, and, you know, that's another one that we're keeping a very close eye on. And then in our inflammation portfolio, we've got the variety of these two assets in autoimmune indications, as we previously indicated, and those programs are ones that I'm quite interested in as we move forward. So thanks for the question. Thank you very much. I appreciate the question. Another question about your commercial model; you mentioned in the prepared remarks a couple of times that you were shifting to more of a digital approach. And I'm

But we firmly believe that the euro have human data is upon us and we believe our collection of capabilities is almost unique in the industry and we intend to push that forward.

Thank you.

Your next question is from Salim Syed with Mizuho Securities.

Great. Good evening, guys and thanks for the question.

One for me strategically.

High level here guys.

When you think about Amgen here is it is it a correct interpretation to say that.

Kristin Haemonchus gone significantly down in interest in solid tumors has gone significantly up and I'm just curious.

Just curious of Kyprolis.

Murdo Gordon: I'm just wondering, you know, we've heard that there have been significant reductions in your commercial field organizations. Can you give us a sense of the magnitude of the efficiency in headcount you're seeing on your average sales force by moving towards digital? And could you talk about how you think that might play out?

To deal with that if that's if that's the correct interpretation. Thank you.

I don't think it is something.

David.

Yes fulfilling.

You can pull us I think has nothing to do with that what youre seeing us the natural evolution of our portfolio.

Based on emerging data and we will expect that to.

B shaped going forward based on emerging data of course, and some other changes we announced today our strategic choices that we had teed up that we had anticipated making.

Murdo Gordon: [inaudible]

Murdo Gordon: Social Distance. Thanks, Geoffrey, for the question. There were a couple of factors that went into our recent reorganization of our field force. One was just portfolio evolution and creating capacity for the new product launches and then reallocating from the older side of the portfolio. And depending on which region you're talking about in the world with Amgen, we're in very different stages of development.

And we think it's a prudent portfolio management to make those choices, let me call out the mcl one programs in particular, where we have elected to move forward with the IV formulation again, we had anticipated we would choose among those molecules and given our ability to more precisely control exposures.

A therapeutic window in collaboration with our investigators are we made that decision and we're moving through dose escalation. After re initiation of that program. So no specific conscious choices based on hematology versus solid tumors and more shaping to come.

Murdo Gordon: So, for example, we're placing large investments in field forces in Japan and in China, even in Russia and some other markets that are emerging for us as being important growth drivers. And in the US, we're really paying close attention to the forces in the market beyond COVID. We're looking at potential negative net price effects and or price reform, as Bob mentioned in his opening remarks, as being a bit of a prevailing wind here.

As data emerges.

Okay, great. Thanks, so much.

So I would just jump in and say, we had a strong quarter on kyprolis in the fourth quarter given the.

The approval of <unk> in our first full quarter promoting it and.

We expect to be able to do.

Murdo Gordon: And so what we're doing is looking at our overall commercial model and, to your point, making it more productive and more efficient. So we're largely on track with that plan. We were able to move very rapidly last year and build out our digital capabilities to an even greater extent than we had historically. We are seeing customers willing to engage in those channels, and we think some of those engagements will be persistent beyond COVID, quite frankly.

A nice job of making.

He Marc specialists around the world are aware of those data in combination with darton that so more growth to come on Kyprolis and <unk>.

A good story now.

Great. Thank you.

Your final question is from Tim Anderson with Wolfe Research.

Hi, This is Andrew gala on for Tim. Thanks for taking my question, just thinking about said or I said in Europe, given the EMA typically has a higher threshold for approval for a single arm studies could you describe your degree of confidence you'll be able to get approved on this 37% response rate in 10 months Dr.

Murdo Gordon: And it's that perseverance that we're betting on. What we haven't done is compromise the ability to have competitive share of voice in our field-facing interactions, both on the medical side and on the commercial side, in front of the customer. And so we think we'll continue to be able to compete effectively in the categories we're in, as well as augment that with highly efficient digital channels of communication.

Yes, sure let me take that question.

We filed in the EU, obviously, we've got ongoing discussions we will provide guidance at the appropriate time, we don't speculate on likely timelines or probabilities in terms of regulatory approvals, but I think it is fair to say the regulators around the world do recognize the large unmet medical need in <unk>.

<unk> with <unk> mutations.

Unknown Executive: Eric, I know we're approaching the top of the hour, and some of our callers might need to drop off, but the management team is available.

After first line therapy.

And that certainly will be the focus of the discussion going forward.

Thank you.

Unknown Executive: I know we still have several questions in the queue. So for those who have questions that they'd like to ask, we'll go beyond the top of the hour and apologize to those of you who have other plans that need to drop off here in two minutes. So, Eric, if you can take us to the next caller. Our next question is from Carter Gould with BART. Thanks, guys. And congrats on the photoraptive data and the impressive execution.

Okay well. Thank you again my apologies for the fact that we went about 12 months over Tonight, but we did want to control of your questions. So thank you for your interest your support of the company and we look forward to seeing you or being back together with you. After the end of the first quarter. Thank you. Thanks everybody.

Ladies and gentlemen, this concludes amgen's fourth quarter 2020 financial results Conference call you may now disconnect.

Okay.

Yes.

Unknown Executive: I guess, Murdo and Bob, coming back to Otesla, at the time of the acquisition, you guys seemed to have told us that the majority of the growth would come from the U.S. And yet, I guess, your comments today seem to be tying up, really, the global nature of the growth going forward. I guess just your level of confidence around Tesla growth in the U.S. through the mid-2025 timeframe, given, you know, the competition and what has happened.

[music].

Yes.

[music].

Okay.

Yes.

Okay.

Moving forward.

[music].

Unknown Executive: Thank you. Maybe I'll just take the first sentence or two and then Murdo, you can embellish them however you'd like. But Carter, what I'd say is that when we acquired it, we said we felt we could achieve double-digit growth through the first several years of ownership, and we continue to feel confident.

Robert.

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Sure.

Yes.

Okay.

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Sure.

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Sure.

Yes.

Okay.

Thanks, John.

John.

John.

[music].

Bob Bradway: Nath, and that's a function of both the potential for increased label range in the U.S. as well as the opportunity to launch an international, or maybe you want to elaborate.

Murdo Gordon: Thanks, Bob. We do see some of the international expansion maturing now. We've got a good business for Otesla in Japan. We're pursuing registration in China, and we recently secured reimbursement in Australia. So we're evolving the global footprint of Otesla beyond where the legacy cell gene efforts had it. So that is one source of growth.

Paul.

[music].

Yes.

[music].

Murdo Gordon: But, as Bob mentioned, we're also pursuing mild to moderate approval in the U.S. on the basis of the positive data set we have there. And that will allow us to move Otesla into a patient population that really is still an unmet need. These are patients who have enough skin surface area that they might be seeking an alternative to messy and inconvenient topical agents.

Yes.

Okay.

Yes.

Okay.

Moving forward.

Yes.

[music].

Murdo Gordon: And I think Otesla can play a very important role there in helping treat those patients. We're also making investments in Otesla by expanding the promotional footprint of the product to include primary care promotion, something that cell gene has not done historically. So we're doing that both for the moderate to severe patient but as well for that mild to moderate indication in anticipation of that potential approval. And then the only other thing I would say is that while we are seeing a little bit of softness in psoriasis and broader rheumatology in the category due to COVID.

Sure.

[music].

Sure.

Murdo Gordon: Otesla being an oral has held up quite well, and the execution has been strong. I also think that the established safety and efficacy profile of Otesla is highly appreciated given recent news in the broader rheumatology category of other orals where perhaps that risk benefit equation is different than it is with Otesla. It's very strong with Otesla. So we think we've got a good opportunity for growth. We also said when we gave that guidance that it assumed a successful competitive program from the TIC2 asset, and of course, that was confirmed today.

Yes.

Okay.

[music].

Yes.

[music].

David M. Reese: Our next question is from Jay Oh, hey, congrats on all the progress. And thank you for taking the question. Since you received breakthrough therapy designations for Sitorusib in China, can you comment on how fast you could submit a filing and gain regulatory approval? And what percent of Asian non-small cell lung cancer patients have the KRAS-P12C mutation and how large?

Jay Olson: [inaudible]

David M. Reese: Thank you. Thanks, Jay.

David M. Reese: We're very pleased to get Breakthrough Therapy designation in China. You know, as our filing plans move forward with our colleagues in Beijing, we'll provide guidance about what those timelines might look like. It has a little bit different implications in China than it does potentially in the United States, and then one thing that we're looking at quite carefully is the epidemiology of G12C mutations. There is a suggestion that it may be a little lower in prevalence in Asian populations, probably because they are mutually exclusive with mutations in EGFR, which are quite high in these populations, up to 40% in, you know, China and Japan, for example. So that would be an important question that we address. We've got active research collaborations now looking at just that. And Myrto, I don't know if you want to add anything about the commercial side in China.

Okay.

Yes.

Yes.

[music].

Murdo Gordon: Yeah, I think, you know, we're obviously very excited about what we can do with the product because there is a huge unmet medical need.

Murdo Gordon: We're seeing, you know, that China is an attractive market for specialty products, and the fact that soduracib is oral makes it very accessible. So we'll pursue commercialization of soduracib in China, and our affiliate is very excited about that.

Colin Nigel Bristow: Great, thank you. Your next question is from Colin Bristow. Hey, thanks for taking the question. Obviously, seeing the abstract data for testopenumab, the less than 150 group looks pretty impressive. I was just curious what your level of confidence is in getting a broad label in light of the fact that you didn't test it for statistical significance. Is that something you've discussed with the FDA previously? And I'll keep it short. Yeah, thanks Colin. This is a question we get frequently.

David M. Reese: You know, we demonstrated efficacy across a broad range of patients, regardless of the eosinophil count. I think that's what clinicians will pay attention to. You know, we'll provide guidance as regulatory discussions proceed. But I think it's too early, of course, prior to submitting, to debate what a potential label would look like.

Yeah.

[music].

Yes.

[music].

Yes.

Michael J. Yee: But, you know, our view is that overall, these are very, very strong data pointing to a differentiated product, and I think this is just going to be a really important medicine for patients with severe uncontrolled Thank you for squeezing me in here.

[music].

Umer Raffat: Just about our similarity, you spiked my ear a little bit talking about the increased competition pressure. Is the anticipation that, in 2021, the price decrease in oncology will exit that 10-15% decline rate? Is there any reason to expect that? Are the payers coming in and making changes? Or is this just an issue of, you know, you're at 550% of the market, it's going to be hard to get a

Moving.

David.

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Yes.

Yes.

Yes.

[music].

Yes.

Unknown Attendee: Yeah, Ronnie, I think we definitely see a diminishing rate of return or gain in terms of volume share; you see that in the shape of our uptake curves for both our oncology biosimilars in the US. You know, I think that, you know, the way these products are used, they're largely used in the community setting, about 80% of the usage of both Bevacizumab and Trastuzumab in a community oncology setting.

Paul.

Paul.

[music].

David.

Yes.

Unknown Attendee: And those businesses tend to contract on a network by network basis. And, you know, by now, most of those contracts are set in motion; there's still some incremental opportunity to add to our overall revenue base. But yeah, I think the gains on volume will be incremental. And then price trends, as I mentioned in my script, the remarks will continue to evolve the way we've seen them. Thank you.

[music].

Yes.

Yes.

[music].

Unknown Attendee: Hey guys, good afternoon. I thought it was interesting to hear about some of the early stage R&D efforts and comments that were made around the induced proximity platform. Along those lines, I was wondering if you could provide a little bit more insight into progress that may have been made within your human genetics initiative and when or how this initiative may translate into new pipeline products. Thanks so much.

Yes.

John.

[music].

David M. Reese: Yeah, thanks, Michael. Within human genetics, as Bob mentioned, and as we previously announced, we have collaborations with Intermountain Health and the UK Biobank that will add up to a million participants. We think we'll have the largest database on earth as these projects move towards completion. And we have broadened our focus on human data to include other omics technologies such as transcriptomics and proteomics, really in the belief that, in the long term, it will be human data such as these that are most important for drug discovery and development.

Yes.

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David M. Reese: You know, at the current time, a majority of our non-oncology portfolio assets have genetic support that's either primary or secondary. And we expect over time that that percentage will simply increase because there is now clear evidence that targets for which there is genetic validation and programs based on them have a higher rate of success. So, more to come, but we firmly believe that the era of human data is upon us, and we believe our collection of capabilities is almost unique in the industry.

Hum.

David M. Reese: We intend to push that forward. Thanks. Great. Good evening, guys. And thanks for the question. Just one for me, at a strategically high level here, guys. When you think about Amgen here, is it a correct interpretation to say that the interest in

Ooh.

Okay.

Paul.

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Salveen Richter: Srinivas Jyothibodhanamayya, Anirudha Mukherjee, Anirudha Mukherjee, Anirudha Mukherjee,

Robert.

Okay.

Okay.

Yes.

Okay.

Paul.

Okay.

Paul.

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Okay.

Yeah.

Okay.

Okay.

Yes.

[music].

David M. Reese: I was curious if Kai Perlis has anything to do with that, if that's the correct interpretation.

Salveen Richter: I don't think it is, Salveen, but I'll invite Dave to... Yes, so Salveen, yeah, you know, Kapollos, I think, has nothing to do with that. What you're seeing is the natural evolution of a portfolio based on emerging data, and we will expect that to, you know, be shaped going forward based on emerging data, of course. And some of the changes we announced today are strategic choices that we had teed up, and we anticipated making, and we think it's prudent portfolio management to make those choices.

Yes.

Salveen Richter: Let me call out the MCL-1 programs in particular where we have elected to move forward with the IV formulation. Again, we had anticipated we would choose among those molecules, and given our ability to more precisely control exposures and achieve a therapeutic window in collaboration with our investigators, we made that decision, and we're moving through dose escalation after reinitiation of that program. So no specific conscious choices based on hematology versus solid tumors, and more shaping up to come as data emerges.

Okay.

[music].

Okay.

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Okay.

Yes.

Murdo Gordon: Okay, great. Thanks so much.

Yes.

Sure.

Unknown Attendee: So Liam, I would just jump in and say, you know, we had a strong quarter on Kyprolis in the fourth quarter, given the approval of CANDOR in our first full quarter promoting it. And we expect to be able to do a nice job of making HIEM-ONC specialists around the world aware of these data in combination with DirectMap. So there is more growth to come on Kyprolis, and it's a good story. Great, thank you.

[music].

Yes.

Okay.

Okay.

Yes.

Yes.

John.

Okay.

John.

[music].

John.

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Yes.

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Yes.

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John.

[music].

Unknown Attendee: Hi, this is Andrew Galler on behalf of Tim. Thanks for taking my question. Just thinking about Thetaracid in Europe, given the EMA typically has a higher threshold for approval for single-arm studies, can you describe your degree of confidence that you'll be able to get approved on this 37% response rate in a 10 month DOR? Yeah, sure. Let me take that question. You know, we filed in the EU.

Yes.

David M. Reese: Obviously, we have ongoing discussions. We'll provide guidance at the appropriate time. We don't speculate on likely timelines or probabilities in terms of regulatory approvals, but I think it is fair to say that regulators around the world do recognize the large unmet medical need in patients with G12C mutations after first-line therapy, and that certainly will be the focus of discussion going forward.

[music].

David M. Reese: Well, thank you again. Apologies for the fact that we went over by about 12 minutes tonight, but we did want to get to all of your questions. So thank you for your interest, your support of the company, and we look forward to seeing you or being back together with you after the end of the first quarter. Thank you. Thank you, everybody.

Unknown Executive: BF-WATCH TV 2021 (inaudible)

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