Q1 2021 Amgen Inc Earnings Call

You're asking one question during the Q&A session.

Arvind Sood: Arvind Sood, Arvind Sood, Arvind Sood,

Great question. Please 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: Erica, thank you. Good afternoon, everybody.

Eric Thank you and good afternoon, everybody welcome to our Q1 call.

Arvind Sood: Welcome to our Q1 call. I think the two key themes for this quarter are continued focus on volume-driven growth and pipeline advancement. Lots to cover, but we'll do our best to stick to an efficient format of limited prepared comments and addressing your one best question. 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 statements. 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. Okay, Bob?

I think the two key themes for this quarter. Our continued focus on volume driven growth and pipeline advancement lots to cover but we'll do our best to stick to inefficient format of limited prepared comments and addressing your one best question.

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 statements are 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, Bob day. Thank you Arvind.

Bob Bradway: Okay. Thank you, Arvind. And hello, everyone, and thank you for joining our call. We've had a busy start to 2021 and a first quarter that's something of a mirror image to what we experienced a year ago. Last year, if you recall, we came out of the gate with a very strong January and February and then started to really feel the impact of the pandemic in March. This year, especially in the U.S., it was almost the reverse.

Hello, everyone and thank you for joining our call.

We've had a busy start to 2021.

And our first quarter Thats something of a mirror image to what we experienced a year ago.

Last year, if you recall, we came out of the gate with a very strong January and February and then started to really feel the impact of the pandemic in March.

This year, especially in the US it was almost the reverse we felt the impact of the pandemic in January and February and we began to see a recovery in March a trend that seems to be holding in April as well.

Bob Bradway: We felt the impact of the pandemic in January and February, and we began to see a recovery in March, a trend that seems to be holding in April as well. Setting aside the pandemic, we executed effectively in the first quarter, and this is reflected in the strong competitive performance of our brands globally, our strong biosimilars showing, the rapid progress of our lead pipeline molecules, and the addition of an attractive phase three ready molecule in oncology.

Setting aside the pandemic, we executed effectively in the first quarter and this is reflected in the strong competitive performance of our brands globally.

Strong biosimilar showing.

Rapid progress of our lead pipeline molecules and the addition of an attractive phase III ready molecule in oncology.

Altogether, we remain confident in our full year outlook for.

Bob Bradway: Altogether, we remain confident in our full-year outlook. We're fortunate to have a diverse portfolio of newer products that continue to show strong volume growth. Repatha, for example, delivered 36% volume growth in the first quarter. It remains the clear leader of the PCSK9 market globally and will soon reach the milestone of 1 million patients served. We're also the global leader in bone health, with Prolia and Avenidae generating double-digit volume in the quarter.

We're fortunate to have a diverse portfolio of newer products that continue to show strong volume growth.

For example delivered 36% volume growth in the first quarter.

It remains the clear leader of the PCF canine market globally and will soon reach the milestone of 1 million patients served.

We're also the global leader in bone health with Prolia, and <unk> entity generating double digit volume in the quarter.

Our industry, leading portfolio of Biosimilars is annualized above the $2 billion, Marc and I would remind you that we have three additional biosimilars in phase III development and look forward to a flow of new launch opportunities for these and Amgen Peter over the next few years.

Bob Bradway: Our industry-leading portfolio of biosimilars is annualizing above the $2 billion mark, and I would remind you that we have three additional biosimilars in Phase 3 development and look forward to a flow of new launch opportunities for these and Amgevita over the next few years. As we've shared with you many times in the past, we're active in business development, looking to complement our internally developed innovation with compelling external opportunities. And our recent acquisition of Five Prime Therapeutics is a good example of that.

As we've shared with you many times in the past we're active in business development looking to complement our internally developed innovation with compelling external opportunities and our recent acquisition of five Prime Therapeutics is a good example of that.

As you know one of the molecules we acquired in that deal <unk> was granted breakthrough therapy designation by the FDA as a first line therapy for a subset of patients with gastric cancer.

Bob Bradway: As you know, one of the molecules we acquired in that deal, femorituzumab, was granted breakthrough therapy designation by the FDA as a first-line therapy for a subset of patients with gastric cancer. More than 1 million new gastric cancer cases are diagnosed annually, and the disease is particularly prevalent in the Asia-Pacific region, which we've said previously will account for approximately 25% of our growth over the next decade. Femortuzumab is now our third late-stage clinical medicine to be granted breakthrough therapy status, joining sodoracib, for which the trade name Lumicrous has now been provisionally approved for use in the U.S., and tezapelimab also has earned that breakthrough therapy distinction. With a strong balance sheet, healthy cash flows, and a proven ability to integrate,

More than 1 million new gastric cancer cases are diagnosed annually in the disease is particularly prevalent in the Asia Pacific region, which we've said previously we will account for approximately 25% of our growth over the next decade.

<unk> is now our third late stage clinical medicine to be granted breakthrough therapy status, joining sooner acid for which the trade name <unk> has now been provisionally approved for use in the us and <unk>.

Also as urns that breakthrough therapy distinction.

With a strong balance sheet healthy cash flows and our proven ability to integrate we will continue to look for external opportunities that strengthen us in our stated areas of focus.

unknown: [inaudible]

Bob Bradway: Before I turn things over to our CFO, Peter Griffith, I want to thank my Amgen colleagues for their continued commitment to serving patients around the world and delivering results for our stakeholders. I look forward to our Q&A session a little later on in our call. For now, over to you, Peter. Thank you, Bob. I would like to take a few moments to reflect on the strong fundamentals of the business and further to reaffirm our full-year revenue and non-GAAP ETS guidance. But first, I want to confirm our predictability.

Before I turn things over to our CFO Peter Griffith.

Thank my Amgen colleagues for their continued commitment to serving patients around the world and delivering results for our stakeholders.

Look forward to our Q&A session a little later in our call, but for now over to you Peter.

Thank you Bob I would like to take a few moments to reflect on the strong fundamentals of the business and further to reaffirm our full year revenue and non-GAAP EPS guidance.

Let me first confirm our predictable consistent capital allocation hierarchy as seen in our Q1 activity.

unknown: Nathaniel, Daniel Lundquist, David Reese, Arvind Sood, Yaron Werber, Salveen Richter. It always begins with investing in

It always begins with investing in internal innovation.

Democrats and heavy Kelly map, both internally discovered and each granted breakthrough therapy designation are excellent examples of this.

unknown: [inaudible]

unknown: are excellent examples of this. We also patiently pursue external business development opportunities that clear our hurdle rate and that are consistent with our areas of therapeutic focus, which we are confident of integrating into Amgen efficiently and effectively on a timely basis.

We also patiently pursue external business development opportunities that clear our hurdle rate and that are consistent with our areas of therapeutic focus and which we are confident of integrating into amgen efficiently and effectively on a timely basis, we allocated $2 billion of our shareholders' capital to the five prime acquisition eight in the second quarter.

unknown: [inaudible]

unknown: Nathaniel, Daniel Lundquist, David Reese, Arvind Sood, Yaron Werber, Salveen Richter

And if committed additional R&D funding to pursue other indications for the lead molecule <unk>.

Our capital expenditures remain a high priority, including investments in our industry leading protein manufacturing.

unknown: Lead Molecule, BEMA. Our capital expenditures remain a high priority, including investment.

Our ESG initiatives, including enabling carbon neutrality by 2027 and Digitization imperative.

unknown: [inaudible] We continue to return capital to our shareholders. First, we pay dividends of $1.76 per share in the quarter, representing a 10% increase from 2020. This year marks our 11th year of dividends, with meaningful increases in each of those years. Second, we repurchased 3.7 million shares in the first quarter at a cost of roughly $865 million. Finally, our capital allocation hierarchy always builds on our efficiency.

We continue to return capital to our shareholders first we paid dividends of $1 76 per share in the quarter, representing a 10% increase from 2020.

This year marks our 11th year of dividends with meaningful increases in each of those years.

Second we repurchased three 7 million shares in the first quarter net cost of roughly $865 million.

Finally, our capital allocation hierarchy always builds on our efficient capital structure, which results in an optimal weighted average cost of capital.

unknown: Ramanan Laxminarayanan, Anirudh Agarwal, Anirudh Agarwal, Anirudh Agarwal, Now I will briefly walk through our first quarter financial results.

Now I will briefly walk through our first quarter financial results.

Recall that in 2021, we are now comparing to a recast 2020 results that exclude the impact of fair value adjustments to equity investments.

unknown: Recall that in 2021, we are now comparing to our recast 2020 results that exclude the impact of fair value adjustments to equity investments that were historically included in non-GAP OI and E. In Q1, revenues decreased 4%. Historically, first quarter sales have been the lowest quarter as a percentage of the full year.

Net where historically included in non-GAAP <unk>.

In Q1 revenue decreased 4%.

Historically first quarter sales have been the lowest quarter as a percentage of the full year.

unknown: As we entered 2021, we knew that COVID would likely introduce some variability. And as the quarter progressed, and we saw a continuing cumulative effect of COVID cases on prescribing patterns, we anticipated that Q1 would be more negatively impacted, which led us to disclose in March that it would be moderately below the 2020 percentage of the full year. First quarter sales benefited from 4% volume growth.

As we entered 2021, we knew that COVID-19 would likely introduce the variability and as the quarter progressed and we saw that continuing cumulative effect of COVID-19 cases on prescribing patterns, we anticipated that Q1 would be more negatively impacted which led us to disclose in March that it would be moderately below 2020.

Percentage of the full year.

First quarter sales benefited from 4% volume growth.

unknown: Looking back to Q1 of 2020, we recorded approximately $150 million of favorable changes to estimated sales deductions, creating a negative impact on year-over-year growth comparisons in Q1 2021. As we get underway with the second quarter, we expect there to be some continuing cumulative COVID impact. While we expect to see improvements in the rate of recovery, that recovery will be more heavily weighted in the second half of the year.

Back to Q1 of 2020, we recorded approximately $150 million of favorable changes to estimated sales deductions, creating a negative impact on year over year growth comparison in Q1 2021.

As we get underway with the second quarter, we expect there to be some continuing cumulative COVID-19 impact while we expect to see improvements in the rate of recovery that recovery will be more heavily weighted to the second half of the year.

Total non-GAAP operating expenses for the quarter increased 2% year over year.

unknown: Total non-GAAP operating expenses for the quarter increased 2% year-over-year. For the full year, we continue to expect cost of sales as a percent of product sales to be 16 to 17 percent. Effective Q2 2021, cost of sales will increase as a percent of product sales in connection with our first shipments of antibodies to Lilly. Recall that revenue from shipments of these antibodies will be recorded in other revenues. For the full year, we expect R&D spend to increase as our innovative pipeline continues to progress, which now includes FEMA from the Five Prime acquisition as well as the Rodeo acquisition. And for the full year, we expect SG&A to spend

For the full year, we continue to expect cost of sales as a percent of product sales to be 16% to 17%.

Effective Q2, 2021 cost of sales will increase as a percent of product sales in connection with our first shipments of antibody for Lilly.

Recall that revenue from shipments of these antibodies will be recorded in other revenue.

For the full year, we expect R&D spend will increase as our innovative pipeline continues to progress, which now includes bema five prime acquisition as well as the rodeo acquisition.

And for the full year, we expect SG&A spend to decline we continue our focus on Digitization imperative.

Non-GAAP <unk> was a net $375 million expense in Q1.

This is unfavorable by $79 million on a year over year basis due.

unknown: and A spend decline. We continue our focus on digitization imperatives.

Due to the recording of our portion of Beijing block this quarter.

Recall the recognition of Beijing results did not start until Q2 2020.

The effects year over year of the adjustments in sales deduction combined with the recognition of the Beijing results totaled about 29 and decrease EPS on a comparison basis for Q1, 'twenty one and.

unknown: Non-GAAP OI&E was a net $375 million expense in Q1. This is unfavorable by $79 million on a year-over-year basis. Due to the recording of our portion of Beijing's loss this quarter. However, please recall that the recognition of Beijing's results did not start until Q2 2020. The effects year-over-year of the adjustments and sales deductions, combined with the recognition of the Beijing results, totaled about $0.29 and decreased EPS on a comparison basis for Q1'21 and explain a large portion of the 12% decline in EPS year over year.

And explain a large portion of the 12% decline in EPS year over year.

Now turning to the outlook for the business for 2021.

Based on underlying market dynamics and our investment plan, we are reaffirming our 2021 guidance with a revenue range of 25 eight to $26 6 billion.

And a non-GAAP EPS range of 16 to $17.

Important additional points to consider as you model the remainder of 2021.

We are providing more specific quarter over quarter guidance given the unprecedented.

Continuing cumulative COVID-19 impacts on the operating environment, but.

But we do not expect to provide such guidance on an ongoing basis.

We see the recovery from COVID-19, more heavily weighted to the second half of the year.

unknown: Now turning to the outlook for the business for 2021. Based on underlying market dynamics and our investment plan, we are reaffirming our 2021 guidance with a revenue range of $25.8 to $26.6 billion and a non-GAAP EPS range of $16 to $17. Important additional points to consider as you model the remainder of 2021. We are providing more specific quarter-over-quarter guidance given the unprecedented continuing cumulative COVID impacts on the operating environment.

And for the second quarter, we expect total revenue to grow between 7% and 10% sequentially from the first quarter.

We continue to expect full year non-GAAP operating expenses to increase by about 7% over last year.

With an operating margin of roughly 50%, which includes operating expenses for five prime and rodeo.

Historically.

The Q2 quarter over quarter operating expense increase is about 10%.

But in the second quarter. This year, we expect quarter over quarter operating expenses to increase in the mid teens percentage range, reflecting the impact of our Lilly COVID-19 antibody manufacturing agreement invest.

Investments for growth, including the five prime acquisition, as well as increasing activity levels, including launch preparation.

For the full year, we continue to anticipate non-GAAP <unk> to be a net expense in the range of one three to $1 5 billion.

Our capital expenditure guidance remains unchanged at $900 million.

unknown: But we do not expect to provide such guidance on an ongoing basis.

unknown: We see the recovery from COVID-19 more heavily weighted to the second half of the year, and for the second quarter, we expect total revenues to grow between 7% and 10% sequentially from the first quarter. We continue to expect full-year non-gap operating expenses to increase by about 7% over last year, with an operating margin of roughly 50%, which includes operating expenses for Five Prime and Rodeo. Historically,

And based on our confidence in the long range outlook of the business. We are raising the upper end of our share repurchase range to $5 billion for 2021 versus prior guidance of $4 billion.

So our range for share repurchases in 2021 is now $3 billion to $5 billion.

Additionally, we are updating our non-GAAP tax rate guidance to 13, five to 14, 5% versus prior guidance of 13% to 14%.

My confidence is strong in the long term outlook for Amgen, given the strength of the business.

And the strength of our outstanding and dedicated team of 23000, plus colleagues that deliver every day to patients and also deliver long term growth to our shareholders.

unknown: The Q2 quarter-over-quarter operating expense increase was about 10%. But in the second quarter of this year, we expect quarterly-over-quarter operating expenses to increase in the mid-teens percentage range, reflecting the impact of our Lilly COVID-19 antibody manufacturing agreement, investments for growth, including the five-prime acquisition, as well as increasing activity levels, including launch preparation. For the full year, we continue to anticipate non-GAAP OI&E to be a net expense in the range of $1.3 to $1.5 billion

This concludes the financial update I will turn it over to Murdo murdo.

Murdo.

Peter first quarter product sales declined 5% year over year volumes grew 4% driven by double digit growth for a number of products, including Prolia, <unk> and vaccines and Tianjin.

Net selling price declined 7% in the year over year comparison was negatively affected by 2% due to a benefit in Q1 2020 from approximately $150 million of changes to estimated sales deductions.

That did not reoccur to the same magnitude in Q1 of 2021.

In the first quarter of the cumulative effect of the COVID-19 pandemic on missed patient visits and diagnoses impacted our business January and February were clearly affected by post holiday COVID-19 spikes in March showed demand improvement across most brands, which has continued into April.

unknown: Our capital expenditures guidance remains unchanged at $900 million. Additionally, based on our confidence in the long-range outlook of the business, we are raising the upper end of our share repurchase range to $5 billion for 2021 versus prior guidance of $4 billion. So our range for share repurchases in 2021 is now $3 to $5 billion. Additionally, we're updating our non-GAAP tax rate guidance to 13.5% to 14.5% versus prior guidance of 13% to 14%. My confidence is strong in the long-term outlook for Amgen, given the strength of the business and the strength of our outstanding.

Despite the impact of the pandemic our teams a sense solutions to address the continuity of care stabilizing our continuing patient volume.

We also saw improvement in customer facing execution throughout the quarter across all communication channels, including face to face and virtual activities.

We expect some COVID-19 related disruptions still in the second quarter with steady recovery thereafter.

I'll now review some product details beginning with our innovative portfolio.

unknown: Nathaniel, Daniel Lundquist, David Reese, Arvind Sood, Yaron Werber, Salveen Richter

In bone health Prolia grew 16% year over year recording over $500 million of us sales in the us for the first time.

unknown: and also deliver long-term growth to our shareholders. This concludes the financial update. I'll turn it over to Murdo. Murdo?

As the majority of osteoporosis patients in the U S has been vaccinated and diagnoses rates are at approximately 90% to pre COVID-19 levels. We're confident in Prolia as continued growth in 2021.

Murdo: Thanks, Peter. The first quarter of product sales declined 5% year-over-year. Volumes grew 4% driven by double-digit growth for a number of products, including Prolia, Repatha, Invassi, and Kanjinji. However, net selling price declined 7%, and the year-over-year comparison was negatively affected by 2% due to a benefit in Q1, 2020, from approximately 100%. $150 million in changes to estimated sales deductions that did not reoccur to the same magnitude in Q1 of 2021.

<unk> sales increased 7% year over year, driven by strong volume growth.

Given the severe impact of fractures on the lives of post menopausal women US entity provides an excellent therapy to build bone first which should then be followed by treatment with prolia.

<unk> sales increased 25% year over year to a quarterly sales record of $286 million.

Driven by 36% volume growth and we maintained global leadership in the Pcs canine class sales.

Sales outside the us grew by 40% driven by strong patient demand in.

In the US we continue to see strength in new patient starts with new to brand prescriptions growing 54% quarter over quarter helped by favorable pharmacy benefit manager formulary changes.

Murdo: In the first quarter, the cumulative effect of the COVID pandemic on missed patient visits and diagnoses impacted our business. January and February were clearly affected by post-holiday COVID spikes, and March showed demand improvement across most brands, which has continued into April. Despite the impact of the pandemic, our teams found solutions to address the continuity of care, stabilizing our continuing patient volume. We also saw improvement in customer-facing execution throughout the quarter across all communication channels, including face-to-face and virtual activity.

U S volume growth demonstrates that we've made good progress against our strategy to provide reports I don't know affordable price to patients, particularly those with Medicare part D coverage.

This acceleration in Medicare part D growth has increased our exposure to the so called donut hole, which create some negative impact on overall net price.

We remain confident in our ability to grow our path of globally to address the significant unmet medical need in treating high risk cardiovascular patients.

Next to aim a day, which remains the market leader in the highly competitive <unk> class <unk> volumes grew 20% year over year in the first quarter with a 45% average total prescription share and 38% average new to brand prescription share.

Murdo: We expect some COVID-19-related disruptions in the second quarter, with steady recovery thereafter. I'll now review some product details, beginning with our innovative portfolio. In bone health, Prolia grew 16% year over year, recording over $500 million in US sales for the first time. As a majority of osteoporosis patients in the U.S. have been vaccinated and diagnosis rates are at approximately 90% of pre-COVID-19 levels, we're confident in Prolia's continued growth in 2021.

Year over year net selling price declined primarily driven by increased rebates to maintain patient access.

Unfortunately millions of patients suffering from migraine or sub optimally treated with older less effective therapies.

Given the head to head data, we've generated showing <unk> superiority against Topiramate. We're confident we can help many more patients suffering from chronic migraine.

Turning to our inflammation portfolio, whereas Tesla has demonstrated a robust safety and efficacy profile with over six years of real world experience in market with more than 500000 patients treated globally Enbrel. Similarly has millions of patients globally since 1998.

Murdo: Evenity sales increased 7% year-over-year driven by strong volume growth. Given the severe impact of fractures on the lives of post-menopausal women, Evenity provides an excellent therapy to build bone first, which should then be followed by treatment with proliac.

But tesla sales were $476 million in the quarter volume growth was 9% driven primarily by 11% total prescription growth in the us.

<unk> remains the market, leading branded systemic medication for psoriasis with an approximately 30% share of first line treatment. However.

However, new to brand prescription volume remained flat as COVID-19 continues to suppress the diagnosis and treatment of psoriasis patients year over year growth was also negatively impacted given pandemic related inventory stocking in Q1 of 2020.

Murdo: Repatha Sales increased 25% year-over-year to a quarterly sales record of $286 million, driven by 36% volume growth, and we maintain global leadership in the PCSK9 class. Sales outside the U.S. grew by 40 percent, driven by strong patient demand. In the U.S., we continue to see strength in new patient starts, with new-to-brand prescriptions growing 54% quarter-over-quarter, helped by favorable Pharmacy Benefit Manager formulary changes. Volume growth in the U.S. demonstrates that we've made good progress against our strategy to provide Repatha at an affordable price to patients, particularly those with Medicare Part D coverage. This acceleration in Medicare Part D growth has increased our exposure to the so-called donut hole, which creates some negative impact on overall net price.

Tesla has more than 90% commercial payer coverage in the us without requiring a biological step and us and affordable safe and efficacious option for psoriasis and Psoriatic arthritis patients.

We see attractive growth opportunities for Tesla as the pandemic recovery progresses. In addition, geographic expansion and the anticipated approval later this year of the mild to moderate psoriasis indication will contribute to future Oh Tesla growth.

In 2021 year over year comparisons for Enbrel are adversely impacted by $255 million of favorable estimated sales deductions that were recorded in 2021.

$115 million of which were in Q1 of 2020.

In the quarter Enbrel sales decreased 20% year over year with declines in both unit volume and net selling price.

Moving forward, we expect volume and net price trends to continue.

Murdo: We remain confident in our ability to grow Repatha globally to address the significant unmet medical need for treating high-risk cardiovascular patients, next to Amavig, which remains the market leader in the highly competitive CGRP class. Amavig volumes grew 20% year-over-year in the first quarter, with a 45% average total prescription share and 38% average new-to-brand prescription share. However, year-over-year net selling price declines were primarily driven by increased rebates to maintain patient access. Unfortunately, millions of patients suffering from migraine are suboptimally treated with older, less effective treatments.

Possible sales decreased 55% year over year, driven by 65% volume declines with partial <unk> inclusion in the end stage renal disease bundle in the U S. We have seen dialysis clinics quickly implement new treatment protocols switching patients from <unk> to generic cinacalcet.

Switching to Biosimilars Q1 sales were $570 million driven by strong volume growth.

Which was partially offset by declines in net selling price. We continue to hold leading biosimilar shares in Europe for Amgen Vita and in the U S for <unk> and <unk>, where we saw average shares of 50% and 43% respectively in Q1.

For the remainder of the year, we expect biosimilar volume growth to be offset by declines in net selling price due to increased competition.

Murdo: Given the head-to-head data we've generated showing Amovig's superiority against topiramate, we're confident we can help many more patients suffering from chronic migraines. Turning to our inflammation portfolio, where Otesla has demonstrated a robust safety and efficacy profile with over six years of real-world experience in the market, with more than 500,000 patients treated globally. Enbrel, similarly, has served millions of patients globally since 1998. But Tesla's sales were $476 million in the quarter.

Longer term growth for Biosimilars will come from expansion of existing products to new markets and launches of additional biosimilar molecules, such as <unk> davita in the us and Biosimilars for Solaris still Lara.

Yes.

In oncology.

<unk> Neulasta on growth remains the preferred long acting G CSF with 54% share of volume in the quarter.

In Q1, we surpassed 1 million patients who with the help us on pro we're able to receive their G. CSF treatment, while reducing the need to return to their doctor's office or other site of care for administration.

System with recent trends in Alaska as U S average selling price declined 30% on a year over year basis, and we expect this trend to continue throughout 2021, driven by intensifying competition.

Murdo: Volume growth was 9%, driven primarily by 11% total prescription growth in the US. Otesla remains the market-leading branded systemic medication for psoriasis with an approximately 30% share of first-line treatment. However, new-to-brand prescription volume remained flat as COVID-19 continued to suppress the diagnosis and treatment of psoriasis patients. Year-over-year growth was also negatively impacted given the pandemic-related inventory stocking in Q1 of 2020.

Ex Java sales decreased 3% year over year for the first quarter as volume growth in Asia was offset by lower net selling price in that region.

Unit volumes declined year over year, driven by demand impacts in January and February with recovery beginning in March and into April.

Kyprolis sales decreased 10% year over year for the first quarter as the pandemic has suppressed the number of new patients starting treatment for multiple myeloma.

Moving forward, we expect promotion to drive growth in second line and beyond as a result of our launch of the combination indication of Kyprolis and <unk> ex plus dexamethasone or <unk>.

Murdo: Otesla has more than 90% commercial pair coverage in the U.S. without requiring a biological step and is an affordable, safe, and efficacious option for psoriasis and psoriatic arthritis patients. We see attractive growth opportunities for Otesla as the pandemic recovery progresses. In addition, geographic expansion and the anticipated approval later this year of the mild to moderate psoriasis indication will contribute to future Otesla growth. In 2021, year-over-year comparisons for Enbrel are adversely impacted by $255 million of favorable estimated sales deductions that were recorded in 2020, 115 million of which were in Q1 of 2020.

The combination of Kyprolis with <unk> and dexamethasone or <unk> was also approved in the quarter.

As Bob mentioned, our team is ready to launch <unk> acid or <unk> upon approval and we are excited to establish it as a foundational therapy for patients with advanced lung cancer, we've already launched our biomarker assist program, which removes access barriers to testing and helps appropriate patients without us.

Market costs.

And 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 more than $2 5 million people in the world living with severe uncontrolled asthma.

Overall, I'm pleased with our Q1 execution, given the pandemic related disruption of new patient diagnoses and treatment and we will continue our focused execution during Q2 and are projecting recovery over the second half of the year with that I'll turn it to Dave.

Murdo: In the quarter, Embraille sales decreased 20% year over year with declines in both unit volume and net selling price. Moving forward, we expect volume and net price trends to continue. Parsibeth sales decreased 55% year-over-year, driven by 65% volume declines.

Thanks, Murdo and good afternoon, everyone I'll begin with two new programs that are strong strategic fits within our portfolio.

First we are excited to welcome our new colleagues from five Prime Therapeutics and begin work on <unk>. The integration is going well and we have hit the ground running with phase III planning activities as Bob mentioned, we received breakthrough therapy designation from FDA and look forward to discussions with regulators on the development program.

Murdo: With Parsibeth's inclusion in the end-stage renal disease bundle, in the U.S., we have seen dialysis clinics quickly implement new treatment protocols, switching patients from Parsibeth to generic Sinocalcet. Moving to biosimilars, Q1 sales were $570 million, driven by strong volume growth, which was partially offset by declines in net selling price. We continue to hold leading biosimilar shares in Europe for Amgevita and in the U.S. for Imvasi and Kanjinti, where we saw average shares of 50% and 43%, respectively, in Q1. For the remainder of the year, we expect biosimilar volume growth to be offset by declines in net selling price due to increased competition.

Including phase III in the near future.

We will also investigate <unk> in other indications, where <unk> may play a role, including squamous non small cell lung cancer and we'll have more to say on the entire development program as those plans are finalized.

In inflammation I would like to highlight our acquisition of <unk> therapeutics and their 15 prostaglandin dehydrogenase program, which was motivated by compelling preclinical data from rodeo and valuable insights from day code. This is a nice illustration of our use of human genetic data to inform drug discovery.

And development.

The <unk> program continues to advance with several regulatory milestones in the first quarter, including global submissions for advanced non small cell lung cancer and a priority review from FDA with a regulatory action date of August 16.

Murdo: Longer term, growth for biosimilars will come from expansion of existing products to new markets and launches of additional biosimilar molecules, such as Amgevita in the U.S. and biosimilars for Solaris, Stellara, and ILEA. In oncology, Neulasta Onpro remains the preferred long-acting GCSF with 54% share of volume in the core. In Q1, we surpassed 1 million patients who, with the help of OnPro, were able to receive their GCSF treatment while reducing the need to return to their doctor's office or other site of care for administration.

We're having productive interactions with the FDA and multiple other regulatory agents agencies that will include Japan with today's anticipated submission and we look forward to making <unk> available to patients as soon as possible.

We're also pleased to receive temporary authorization for us status in France. This designation is to promote fast access to innovative medicines before marketing authorization and conventional access and we have received a large number of requests.

And the clinical development program, we completed enrollment in the phase III study versus Docetaxel in advanced non small cell lung cancer.

Based on the overall efficacy and safety profile of <unk>, Kras and discussions with regulators, we reduce the sample size in this study while maintaining appropriate statistical power to assess the progression free survival primary endpoint.

Murdo: Consistent with recent trends, Nelasta's US average selling price declined 30% on a year-over-year basis, and we expect this trend to continue throughout 2021, driven by intensifying competition. Xgeva sales decreased 3% year-over-year for the first quarter as volume growth in Asia was offset by lower net selling prices in that region. U.S. unit volumes declined year-over-year, driven by demand impacts in January and February, with recovery beginning in March and into April.

The timelines of the study have not changed as the primary endpoint remains event driven.

We have demonstrated that the 960 milligram dose is safe and efficacious in advanced non small cell lung cancer, we continue to explore different doses and regimens as is common in oncology drug development.

As part of this effort, we are initiating a new cohort to determine whether a once daily oral dose of 240 milligrams maintains the safety and efficacy profile of the 960 milligram dose in patients with advanced non small cell lung cancer.

Murdo: Kyprolis sales decreased 10% year over year for the first quarter as the pandemic suppressed the number of new patients starting treatment for multiple myeloma. Moving forward, we expect promotion to drive growth in the second line and beyond as a result of our launch of the combination indication of Kyprolis and Darzalex plus dexamethasone or DKD. The combination of Kyprolis with Sarcleza and dexamethasone, or ESA-KD, was also approved in the court. As Bob mentioned, our team is ready to launch Sotiracib or Lumicraz upon approval, and we're excited to establish it as a foundational therapy for patients with advanced lung cancer. We've already launched our Biomarker Assist program, which removes access barriers to testing and helps appropriate patients without a pocket cost.

Should a lower dose is safe and efficacious as 960 milligrams. It may further enhance the patient experience with once daily Luma Kras.

We expect the results from this study in late 2022 or early 2023, and do not expect any impact on the timelines of our ongoing priority review.

We also continue to make good progress in evaluating combination regiments efficacy cohorts are underway for our mechanism bitter egfr antibody and oral egfr inhibitor combinations and we expect to present updates on these regimens at medical meetings in the second half of the year we can.

To evaluate doses and regimens to find the optimal options for patients in our other combinations, including PD, one and ship to.

Finally, we are initiating triplet cohorts in colorectal cancer, <unk> kras with standard of care chemotherapy, and either an anti egfr or anti VEGF antibody.

Murdo: And 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 more than 2.5 million people in the world living with severe uncontrolled asthma. Overall, I'm pleased with our Q1 execution given the pandemic-related disruption of new patient diagnoses and treatment, and we'll continue our focused execution during Q2 and are projecting recovery over the second half of the year. With that, I'll turn it to Dave.

In our bite programs, we've initiated several new studies, including new indications for AMG 160, <unk> targeting <unk> in non small cell lung cancer and AMG 700, <unk> seven targeting DLL three now also being investigated in neuroendocrine prostate cancer <unk>.

<unk> on these and other development programs, including small molecules can be found in our press release.

Turning to <unk> Mab developed in collaboration with Astrazeneca, our phase III navigator data were well received by clinicians and additional analyses will be presented at the American Thoracic Society meeting in May we remain on track to submit regulatory filings this quarter and believe the data support <unk>.

Dave: Thanks, Murdo, and good afternoon, everyone. I'll begin with two new programs that are strong strategic fits within our portfolio. First, we are excited to welcome our new colleagues from Five Prime Therapeutics and begin work on bumerituzumab. The integration is going well, and we have hit the ground running with Phase 3 planning activities. As Bob mentioned, we received breakthrough therapy designation from FDA and look forward to discussions with regulators on the development program, including Phase 3, in the near future.

<unk> as a first line biologic therapy for a broad population of patients with severe uncontrolled asthma.

We're also investigating other indications with phase III studies in COPD and chronic spontaneous urticaria and most recently a phase III study for chronic rhinosinusitis with nasal polyps.

Finally on a Tesla, we submitted a supplemental new drug application to FDA based on the phase III advanced study in mild to moderate psoriasis. The positive results from advance were presented at the American Academy of dermatology or AAD meeting.

Dave: We will also investigate pomerituzumab in other indications where FGFR2B may play a role, including squamous non-small cell lung cancer, and we'll have more to say on the entire development program as those plans are finalized. In inflammation, I would like to highlight our acquisition of Rodeo Therapeutics and their 15-prostaglandin dehydrogenase program, which was motivated by compelling preclin This is a nice illustration of our use of human genetic data to inform drug discovery and development.

Few days ago and.

In closing I'd like to thank our staff for continuing to deliver for patients.

Okay.

Okay, Eric Thank you, let's turn now to Q&A and perhaps you could reminder.

And our callers of the procedure for asking questions.

As a 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 is from Geoff Meacham with Bank of America.

Hey, guys. Thanks for the question.

I had a question on our Tesla the head to head against the crab is sitting up.

Dave: The LumaCrafts program continues to advance with several regulatory milestones in the first quarter, including global submissions for advanced non-small cell lung cancer and a priority review from FDA with a regulatory action date of August 16. We are having productive interactions with the FDA and multiple other regulatory agencies, which will include Japan with today's anticipated submission, and we look forward to making LumaCrafts available to patients as soon as possible. We are also pleased to receive temporary authorization for use status in France. This designation is to promote fast access to innovative medicines before marketing authorization and conventional access. And we have received a large number of requests.

At AAD showed some pretty meaningful differentiation I just wanted to ask from a maybe a commercial perspective, how does that data set along with the advanced state of change you're thinking about the positioning of hotels on the marketplace with respect to psoriasis. Thank you.

Murdo, yes.

Yes, Thanks, Jeff for the question.

The first thing I would just reiterate is that we anticipated.

The Duke data would indeed show what they did show and we assume that in the model that we put together for the transaction and we've assumed that for the balance of this year.

What I would say is that we continue to believe that hotez, let us really ideally positioned in the.

First line pre biologic psoriasis market as I mentioned in my prepared remarks, we've been on the market for six years now we have in market cumulative patient experience with over 500000 individuals globally.

Dave: In the clinical development program, we completed enrollment in the phase 3 study versus dosotaxel in advanced non-small cell lung cancer. Based on the overall efficacy and safety profile of LumaCRAS and discussions with regulators, we reduced the sample size in this study while maintaining appropriate statistical power to assess the progression-free survival primary endpoint. The timelines of the study have not changed as the primary endpoint remains event-driven.

We have excellent.

Commercial and.

Payer coverage at over 90% of covered lives.

We continue to make really good progress holding a 30% share in the market with really outstanding.

Customer facing capabilities. The other thing that we of course look at us positioning in the market and how that holds up against not just duker, but other competitors and we think that we really are the first kind of option pre biologic post topical.

Dave: While we have demonstrated that the 960 mg dose is safe and efficacious in advanced non-small cell lung cancer, we continue to explore different doses and regimens, as is common in oncology drug development. As part of this effort, we are initiating a new cohort to determine whether a once-daily oral dose of 240 mg maintains the safety and efficacy profile of the 960 mg dose in patients with advanced non-small cell lung Should a lower dose be as safe and efficacious as 960 mg, it may further enhance the patient's experience with once-daily Lumicrat.

And dermatologists have become very comfortable using Oh, Tesla that way payer coverage is consistent with that position in the market.

And.

With the mile to pending mild to moderate indication.

Data, which were presented at the same AAD meeting, which look quite compelling.

We expect to be able to expand our utilization of those.

<unk> psoriasis population and the milder patient type so.

Overall, we like our position in the market.

The way I see it as are we.

We still have to.

See how the full detailed safety data look.

Dave: We expect the results from this study in late 2022 or early 2023 and do not expect any impact on the timelines of our ongoing priority review. We also continue to make good progress in evaluating combination regimens. Efficacy cohorts are underway for our MEK inhibitor, EGFR antibody, and oral EGFR inhibitor combinations, and we expect to present updates on these regimens at medical meetings in the second half of the year. We continue to evaluate doses and regimens to find the optimal options for patients in our other combinations, including PD-1 and SHIP-2. Finally, we are initiating triplet cohorts in colorectal cancer of the lumacrass with standard-of-care chemotherapy and either an anti-EGFR or anti-VEGF antibody.

For the TIK two product given that it is part of the Jack family and.

It took six years and over 200000 patients for us to understand the Xeljanz safety profile. So I think there's a lot still to be understood here, but but not necessarily the safety and efficacy of Oh Tesla.

Okay, great. Thank you.

Your next question is from Michael Yee with Jefferies.

I had a question maybe for David.

You had a nice update and comments, Sean K rash, maybe you could just.

Put some context around the timing of data now for the second half around Mac, maybe talk about what drives the timing of that and disclosure and then the comment around $2 40 versus 960, I think there'd be different ways to interpret that maybe you can make a comment about that because I thought 960 was pretty well tolerated profile Sean.

Dave: In our BITE programs, we have initiated several new studies, including new indications for AMG-160, targeting PSMA in non-small cell lung cancer, and AMG-757, targeting DLL-3, now also being investigated in neuroendocrine prostate cancer. Details on these and other development programs, including small molecules, can be found in our press release. Turning to tezapelumab, developed in collaboration with AstraZeneca, the phase 3 navigator data were well received by clinicians, and additional analyses will be presented at the American Thoracic Society meeting in May.

Let me make some comments on that that would be great. Thanks, David.

Yes, Thanks, Mike are both great questions I think.

Our anticipation is that at meetings right after the second half.

Right into the start of the second half of the year, we'll start to see.

Some of the cohort data that we outlined Mac.

Both egfr antibody or small molecule inhibitor combinations.

You can probably see those come out sequentially over the second half of the year as we accumulate data I would say that the combination therapy programs are moving along quite rapidly.

Dave: We remain on track to submit regulatory filings this quarter and believe the data support tezapelumab as a first-line biologic therapy for a broad population of patients with severe uncontrolled asthma. We are also investigating other indications with phase 2 studies in COPD and chronic spontaneous urticaria, and most recently, a phase 3 study for chronic rhinosinusitis with nasal polyps. Finally, on Tesla, we submitted a supplemental new drug application to FDA based on the phase three advanced study in mild to moderate psoriasis.

As we mentioned we've opened some new triplet combination so I feel very good.

Where we are in the status of combination regimens are in terms of the dose comparison study.

Now got long term data from both our phase one trial.

As well as the phase II trial.

Our updated target coverage information pharmacokinetics.

As well as of course efficacy and safety data and based on modeling.

We wandered off could we achieve adequate target coverage at $2 50, and preserve potentially the same efficacy profile.

Dave: The positive results from ADVANCE were presented at the American Academy of Dermatology, or AAD, meeting a few days ago. In closing, I'd like to thank our staff for continuing to deliver for patients. Bob? Okay, Erica. Thank you. Now we turn now to Q&A, and perhaps you could remind our

Okay.

That we've seen at 960 milligrams.

And so that's just a question that we're going to ask us quite common to continue.

Dose.

Exploration.

Erica: Callers of the procedure for asking questions. Thanks.

<unk> molecules.

Murdo: As a reminder, to ask a question, you will need to press star one on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Your first question is from Geoff Meacham with Bank of America.

And I would view this as a par for the course, we are very pleased with the Tolerability profile and as you pointed out at 960 milligrams.

We've had an outstanding experience in fact this is one of the best tolerated drugs that I've been involved with <unk>.

30 years in oncology drug development.

Murdo: Murdo? Yeah, thanks, Geoff, for the question. The first thing I would just reiterate is that we anticipated that the DUCRA data would indeed show what they did show, and we assumed that in the model that we put together for the transaction, and we've assumed that for the balance of this year. What I would say is that we continue to believe that OTESLA is really ideally positioned in the first-line prebiologic psori

And that's not really what.

The driver is here, but can we potentially get by with efficacy at a lower 240 milligram dose.

And.

Enhance the patient experience.

Yes. Thank you.

Your next question is from Jay Olson with Oppenheimer.

Oh, Hey, thanks for taking the question.

Curious about the phase two data for oil patch that you expect in the first half of next year can you just talk about what sort of signals youll be looking for in that data in terms of your plans to design a phase III study and any potential points of differentiation from pellet Carson.

Murdo: As I mentioned in my prepared remarks, we've been on the market for six years now, and we have in-market cumulative patient experience with over 500,000 individuals globally. We have excellent commercial and payer coverage at over 90% of covered lives. And we continue to make really good progress, holding a 30% share in the market with really outstanding customer-facing capabilities. The other thing that we, of course, look at is positioning in the market and how that holds up against not just Duker but other competitors.

Thank you.

Yes, Thanks, Jay and for those who may not know off the top of their heads what will pass around US. This was formerly AMG 890, it's small interfering RNA.

Combined to lower LIFO protein levels in patients.

With asos chronic cardiovascular disease, where April elevated LP little a may be a driver.

As we noted we completed enrollment in a what's a robust phase II trial that actually completed enrollment ahead of schedule.

Murdo: And we think that, you know, we really are the first kind of option pre-biologic post-topical. And dermatologists have become very comfortable using O Tesla that way. payer coverage is consistent with that position in the market. And with the pending mild to moderate indication data, which were presented at the same AAD meeting and looked quite compelling, we expect to be able to expand our utilization of OTesla and the psoriasis population in the milder patient type.

And what we'll be looking for as we unveil those data.

Jay are first of all longer term.

Follow up meaning sufficient long term suppression of LP little a levels.

Our targets would be in the range of the phase one data that we presented last November at the American Heart Association meeting and then of course saw additional.

Safety data and of course, we are exploring different dose levels as us.

Murdo: So overall, we like our position in the market. But the way I see it is we still have to see how the full detailed safety data look for the TIC2 product given that it is part of the Jack family. And, you know, it took six years and over 200,000 patients for us to understand the ZELGAN safety profile. So I think there's a lot still to be done. understood here but not necessarily the safety and efficacy of OTesla.

Pretty much standard.

In a program like this and so this would be in part for dose selection for phase III going forward. We are very actively engaged already in phase III planning and what the design of that sort of trial may look like based on the data that we've seen to date.

One of our goals may be relatively infrequent dosing given the duration of effect that we have.

unknown: Okay, great.

David: Your next question is from Michael Yee with Jeffreys.

Observed in the phase one trial and Thats, one thing that we'll be taking a close look at us well in phase II.

David: I had a question, maybe for David. You had a nice update and comments on KRAS. Maybe you could just put some context around the timing of data now for the second half around MEC, maybe talk about what drives the timing of that and disclosure. And then the comment about 240 versus 960. I think there'd be different ways to interpret that. Maybe you could make a comment about that, because I thought 960 was pretty well tolerated. It's got a good profile.

Alright, great. Thank you.

Our next question is from Matthew Harrison with Morgan Stanley.

Okay.

Great. Good afternoon, thanks for taking us.

I was wondering if you could.

More detail on the trends it looks like.

We're really starting to see the product breakout a little bit here and not seeing some of those first quarter gross to net issues that you've sort of experience.

A couple of years.

Do you think youre at a point now where youre going to get us substantial part D penetration and also see rest of world penetration, maybe you could just comment on your outlook there.

Yes. Thank you Matthew we are pleased obviously with the quarter for a path on.

David: So maybe you could make some comments on that. That would be great. Thanks, David. Yeah, thanks, Mike. Both great questions.

It's been a bit of a journey getting here and trying to ensure that patients have affordable access to a path of particularly in Medicare part D. As you point out.

David: You know, I think, you know, our anticipation is that at meetings, right after the second half, you know, right into the start of the second half of the year, we'll start to see some, So, I just wanted to share with you some of the cohort data that we outlined for MEK and then both EGFR antibody and small molecule inhibitor combinations. And, you know, you can probably see those come out sequentially over the second half of the year as we accumulate data.

I would say that we are anticipating with one exception, we are anticipating relatively stable net price for the remainder of the year and the exception that.

Pointing out is that as we expand our penetration of Medicare part D. We will have.

Some drag on our net price as a function of patients entering and staying in the donut hole for a period of time so.

David: I would say that the combination therapy programs are moving along quite rapidly. And, as we mentioned, we've opened some new triplet combinations, so I feel very good about combination regimens. In terms of the dose comparison study, we now have long-term data from both our phase one trial and the phase two trial, updated target coverage information, pharmacokinetics, as well as, of course, efficacy and safety data, and based on modeling, we wondered, could we achieve adequate target coverage at 250 and preserve potentially the same efficacy profile?

The one downside of helping patients in Medicare part D. There is still a coverage gap in that benefit.

And of course.

The given the durability of treatment in the chronic nature of your path as they can be in net.

Coverage gap for quite a bit so we do have more exposure to the donut hole overtime, but as you could tell from the first quarter, we were more than able to offset that that small drag on <unk>.

Net price and we anticipate that we will continue to penetrate that patient population given the very strong payer coverage, we have there with between commercial and Medicare We've got over 80% covered lives for this important product and there are still millions of patients out there who are sub optimally treated for their hyperlipidemia.

Given that they are at very high risk of cardiovascular events, so and globally, we're seeing some really strong performance in Europe and the Americas.

David: That we've seen at 960 milligrams, you know, and so, you know, that's just a question that we're going to ask. It's quite common to continue dose exploration in oncology molecules, and I would view this as par for the course. We are very pleased with the tolerability profile, and as you pointed out, at 960 milligrams, we had, you know, an outstanding experience. In fact, this is one of the best-tolerated drugs that I've been involved with, you know, in 30 years of oncology drug development, and that's not really, you know, what a driver here, but, you know, can we potentially get by with efficacy at a lower 240-milligram dose and, you know, enhance the patient experience?

In China.

Is doing quite well.

<unk> not having an <unk> listing and we continued to make inroads in Japan, where we are the only <unk> on the market.

Your next question is from urine <unk> with Cowen <unk> company.

Great. David If you don't mind I just have a follow up question as well about the loom across relating to PD. One combo, specifically I think you've said in the past that you haven't gotten to the MPD on both.

Both drugs Hudson.

Combination it sounds like you're continuing to explore dose and schedule. You've also recently talked about sequential therapy. So we're just trying to say are we actually going to get data in the second half and why are you testing sequential therapy. What are you trying to say thank you.

Thanks Sharon.

We're continuing to look at a variety of.

Approaches in combination with PD ones, whether that's in combination or sequentially.

Sequentially.

It's fair to say.

Jay Olson: Your next question is from Jay Olson with Oppenheimer.

A number of small molecules Egfr inhibitors, BRAF inhibitors, mec inhibitors have challenges combining with.

unknown: Oh, hey, thanks for taking the question. I'm curious about the Phase 2 data for Opasaran that you expect in the first half of next year. Can you just talk about what sort of signals you'll be looking for in that data in terms of your plans to design a Phase 3 study and any potential points of differentiation from Pelicarcin? Thank you.

PD ones.

And I think there's a fair amount of work out here we are all.

We will provide updates I don't know if we'll have data that's robust enough to share in the second half of the year, that's possible, but I don't want to promise that but certainly we will provide guidance on as those <unk>.

Different regimens move along and sequential therapy.

David: As we noted, we completed enrollment in what's a robust Phase 2 trial that actually completed enrollment ahead of schedule. And what we'll be looking for as we unveil those data, Jay, are first of all, you know, longer term, Follow-up, meaning sufficient long-term suppression of LP little a levels and you know our targets would be in the range of the phase one data that we presented last November at the American Heart Association meeting and then of course additional safety data and of course we are exploring different dose levels as is pretty much standard in a program like this and so this would be in part for dose selection for phase three going forward.

Actually a preferred approach here.

Your next question is from Terence Flynn with Goldman Sachs.

Hi, Thanks for taking the question, maybe just just one follow up on that.

Dave I was just wondering does the 940 Meg dose exploration have to do with this question on.

How to best combine <unk> with a PD one and then my other question I just was wondering Bob or Peter if you could comment on the tax proposals coming out of D C and any implications for your Puerto Rico.

Some of the tax benefits you get out of Puerto Rico on the manufacturing side. Thank you.

Thanks, Terence I'll take the first part of that question yes.

David: We are very actively engaged already in phase three planning and what the design of that sort of trial may look like. Based on the data that we've seen to date, one of our goals may be relatively infrequent dosing given the duration of effect that we observed in the phase one trial, and that's one thing that we'll be taking a close look at as well in phase three.

Yes.

240 milligram dose comparison study.

It doesn't have really anything to do with the combinations.

Dosing as Youre aware.

In combination regimens in oncology, one typically explores a range of doses.

Potentially.

All of the members of that combination regimen, depending on what the backbone may be but this is really a mono therapy exploration.

Matthew Harrison: Great, thank you. Your next question is from Matthew Harrison with Morgan Stanley.

And again determined to see whether we can preserve efficacy at a lower dose at this lower 240 milligram dose.

unknown: Great. Good afternoon. Thanks for taking the question, giving a little more detail on the rough, and it looks like we're really starting to see the product.

On the tax front, Peter once you share thoughts.

Very good question there.

Look I think it's premature to speculate on where.

unknown: Nathaniel, Daniel Lundquist, David Reese, Arvind Sood, Yaron Werber, Salveen Richter

We expect the administration's proposals.

Subject I think as everybody does too significant debate within Congress and other stakeholders.

Murdo: Yeah, thank you, Matthew. We are pleased, obviously, with the quarter for Repatha. And, you know, it's been a bit of a journey getting here and trying to ensure that patients have affordable access to Repatha, particularly in Medicare Part D, as you point out. I would say that, with one exception, we are anticipating a relatively stable net price for the remainder of the year. And the exception that I'm pointing out is that as we grow up quite a bit, so we do have more exposure to the donut hole over time.

Rest assured we are active in Washington to ensure that our position that our taxes you should continue to be competitive.

And should we continue to really encourage innovation in the United States as well heard and understood.

And.

We are very supportive and you can imagine us incentives to encourage manufacturing in the United States in the U S territory in Puerto Rico.

And I would just let you know that our tax liter Jackie growth.

With much expertise in the area of Puerto Rico, not just around taxes, but just overall into how the economy down there functions and so forth, which is called upon regularly by the legislature.

Murdo: But as you can see from the first quarter, we were more than able to offset that small drag on net price. And we anticipate that we'll continue to penetrate that patient population, given the very strong payer coverage we have there with, you know, between commercial and Medicare, we've got over 80% covered lives for this important product. And there are still millions of patients out there who are suboptimally treated for their hyperlipidemia, given that they're at very high risk of cardiovascular events.

Advisory Council.

Thanks again for the questions.

Your next question is from Nomura asset with Evercore ISI.

Hi, Thanks, so much for taking my question, David I have a two part question on <unk>.

First perhaps if you could just walk us through your thought process on why 240 in particular, why not 180 or 360, and I say that in the context of having seen responses as low as 180, perhaps you could even give us a flavor for the PK curves look like around the $2 40 doses above and below.

I recall back when the phase III was initiated per K Ras the powering math was really directed at OFC not PFS, even though the primary endpoints of PFS.

Murdo: So globally, we're seeing some really strong performance in Europe and the Americas. China is doing quite well, despite not having an NRDL listing. And we continue to make inroads in Japan, where we are the only PCSK9 on the market.

I realize the conversations with FDA have moved towards PFS and it looks like the new powering is more than reasonable for PFS, but I do want to understand the evolution and thought process away from Oss and what we can reasonably expect on P values around OS with data as it emerges. Thank you.

Yaron Werber: Your next question is from Yaron Werber with Calum Great. David, if you don't mind, I just have a follow-up question as well about

David: David, if you don't mind, I just have a follow-up question as well about LumaCrest, relating to PD-1 combo specifically. I think you've said in the past that you haven't gotten to the MTD on both drugs as you tested them in combination, and it sounds like you're continuing to explore dose and schedule. You've also recently talked about sequential therapy, so we're just trying to say, are we actually going to get data in the second half, and why are you testing sequential therapy? What are you trying to say? Thank you.

Thanks.

Good questions.

240 milligram dose was chosen based on modeling that we've done.

And that really takes account of all of the dose levels pharmacokinetic data target coverage data our accumulated preclinical data regarding.

Efficacy at different target coverage levels.

And this was really chosen as a lower bound where we thought we would potentially preserve or could preserve the efficacy that we're seeing at 960 milligrams.

David: Yeah, thanks, your own, we're continuing to look at a variety of approaches in combination with PD ones, whether that's in combination or sequentially. I think it's fair to say that a number of small molecules, EGFR inhibitors, BRAF inhibitors, MEK inhibitors, had challenges combining with PD-1s, and I think there's a fair amount of work out here. We are, you know, we I don't know if we'll have data that's robust enough to share in the second half of the year. That's possible, but I don't want to promise that, but certainly we'll provide guidance as those different regimens move along, and sequential therapy may actually be a preferred approach here.

In regards to the phase III trial as you note, we changed the powering to really.

We have good power on the progression free survival endpoint that was done in concert with regulators.

We'll be able to take a look at overall survival.

The power will be somewhat reduced.

In terms of the overall survival.

Endpoint, but I think we will still have.

Pretty good sense of what the drug is producing in terms of overall survival are part of the thinking here as well as to minimize exposure.

All patients to the Docetaxel control arm.

Thank you.

Your next question is from Mohit Bansal with Citi.

Unknown Executive: Your next question is from Terrence Flynn with Goldman Sachs.

David: Hi. Thanks for taking the question. Maybe just one follow-up on that, Dave. I was just wondering, does the 940 mg dose exploration have to do with this question on, you know, how to best combine KRAS with PD-1? And then my other question, I just was wondering, Bob or Peter, if you could comment on the tax proposals coming out of D.C. and any implications for your Puerto Rico, you know, some of the tax benefits you get out of Puerto Rico on the manufacturing side. Thank you.

Question and maybe one question for Murdo.

So.

Umpqua has done really well.

Pandemic could.

Could you please remind us how often these contracts that are negotiated and should we expect any reversal in entre trends, you're seeing anything there as dependent except site. Thank you.

Thanks Mohit.

The contracts aren't necessarily on a schedule, we have some large networks where we.

We negotiate annually, but we have a lot of smaller what we call value based accounts, where we contract on a much more.

David: Thanks, Terence. I'll take the first part of that question. Yeah, the 240-milligram dose comparison study doesn't really have anything to do with the combination dosing. As you're aware, in combination regimens in oncology, one typically explores a range of doses, you know, potentially of all of the members of that combination regimen, depending on what the backbone may be. But this is really a monotherapy exploration and, again, determined to see whether we can preserve efficacy at a lower dose, at this lower 240-milligram dose.

Non calendar is basis, so they're happening throughout the course of the year.

And as your question with respect to reversal.

Are you asking me about price trends volume trends can you clarify that question I mean, the trends I mean, because there was a trend towards using more on core versus the PFS given it is particularly in the at home products. So do you think there could be some kind of reversal there as the pandemic subsides, because then patients can come in and they'll get there.

Yes. Thank you for the clarification, obviously, we're watching that clearly the pandemic was stimulus for many oncologists to think more carefully about the G. CSF.

Peter H. Griffith: On the tax front, Peter, why don't you share our thoughts? I would. Terrence, a very good question there. And look, I think it's premature to speculate on this.

Treatment that they were going to us in order to help minimize the amount of provider interaction that patients would incur what we have been doing in the meantime, though is reinforcing that you actually can improve outcomes by using long acting G CSF and using on pro in particular, so we have a promotional effort.

Peter H. Griffith: I'm not sure to speculate on this. We expect the administration's proposals to be subject, I think, as everybody does, to significant debate within Congress and other states.

unknown: Nathaniel, Daniel Lundquist, David Reese, Arvind Sood, Yaron Werber, Salveen Richter, Daniel Lundquist, Jamie Shen, Robert Bradway, Murdo Gordon, David Reese, Arvind Sood, Yaron Werber

That I think is helping strengthen the volume demand curve. The only thing I will continue to point out though is with competition come some price erosion and we have a new competitor entrant in that category in the long acting G. CSF category. So we anticipate more net price.

unknown: and should continue to really encourage innovation in the United States is well heard and understood. And we are very supportive, as you can imagine, of incentives to encourage manufacturing in the United States and the U.S. territory of Puerto Rico.

Evolution negative evolution through the remainder of the year.

Got it thank you very much.

Your next question is from Geoffrey Porges with SBB Larry.

Alright, Thank you very much for the question.

unknown: Pagano, and Terrence, I would just let you know that our tax leader, Jackie Krause, has much expertise in the area of Puerto Rico, not just around taxes, but just overall into how

Could you just discuss the issue of price.

Pretty significant negative price effect first of all could you tell us whether that's all in the us whether it's U S and ex U S. And then secondly in the US took significant price increases at the end of the year.

unknown: She's called upon regularly by the legislatures for advice and counsel. Thanks again for the question.

Umer Raffat: Your next question is from Umer Raffat with Evercore ISI.

David: Hi, thanks so much for taking my question.

But still have negative price Q on Q.

David: David, I have a two-part question on CARAS. First, perhaps, if you could just walk us through your thought process on why 240 in particular? Why not 180 or 360?

Looks like eight or 9%.

Is this going to be a trend that persist throughout the year and then perhaps you could comment on what we should be modeling in terms of legislative or executive order changes to pricing going forward.

David: and I say that in the context of having seen responses as low as 180, perhaps you could even give us a flavor for what the peak hikers look like around the 240 doses above and below. And secondly, I recall back when phase three was initiated for KRAS, the powering map was really directed at OS, not PFS, even though the primary endpoints were PFS. I realize the conversations with FDA have moved towards PFS and that it looks like the new powering is more than reasonable for PFS, but I do want to understand the evolution and thought process away from OS and what we can reasonably expect on P values around OS with data as it emerges.

You usually have your finger on the pulse in Washington.

Sure Alright. Thanks, Thanks, Jeff Let me go first on the overall price evolution in the portfolio. We continue to believe that mid single.

Single digit net negative price for the portfolio for the years the right number that's what we continue to see what what you know and what we experienced probably more than some of our peer companies in the first quarter given the nature of our portfolio is more net negative price evolution because of patients renewing in their <unk>.

Assets and going through benefit verification and hitting their kind of out of pocket resets and so our co pay assistance programs have more drag we did activate more payer access at the end of last year into this so we did have on some brands some increased pay.

David: Yeah, thanks, Umer. Good.

David: Thanks, Umer. Good questions.

David: The 240 milligram dose was chosen, you know, based on modeling that we've done that really takes account of all of the dose levels, pharmacokinetic data, target coverage data, or accumulated preclinical data regarding efficacy at different target coverage levels. And, you know, this was really chosen as a lower bound where we thought we would potentially preserve or could preserve the efficacy that we're seeing at 960 milligrams You know, in regards to the Phase 2 trial, you know, as you note, we changed the powering to really have good power on the progression-free survival endpoint.

Coverage at the cost of some net price negative evolution, but we do anticipate Q1 being the lowest compare Q2, a little better and then Q3 and Q4 being better thereafter.

Great. Thank you and Jeff on Washington, Im not sure whether executive orders.

The concern these days.

Whether it's something that's attached to reconciliation if I had to guess I'd say the greater risk is something being attached to reconciliation, but it is still not very clear how this administration and members of the Democratic Party General wanted to try to tackle the question of drug pricing.

David: That was done, you know, in concert with regulators. We will be able to take a look at overall survival. You know, the power will be somewhat reduced in terms of the overall survival endpoint, but, you know, I think we'll still have a pretty good sense of what the drug is producing in terms of overall survival. Part of the thinking here as well is to minimize exposure of patients to the docetaxel control arm.

This year. So we're continuing to stay very involved as you would expect.

We have a benefit I think us being able to demonstrate.

Just how important innovation is with <unk>.

Progress you see being made against the pandemic.

And.

So we'll continue to stay active and focused on the things that can be done to improve patient access to medicines.

The other thing Jeff is to continue to shine a light on the on the role of the middlemen and how much of the pharmaceutical dollars now lined up in the hands of the middlemen, which was which.

Mohit Bansal: Your next question is from Mohit Bansal with Citi.

Mohit Bansal: Question, and maybe one question for Murdo. So, ANTRO has done really well during this pandemic. Could you please remind us how often these contracts are negotiated? And should we expect any reversal in ANTRO trends? Are we seeing anything there as the pandemic subsides? Thank you.

Across the country is just in excess of 50% I think it actually is at 51% now so we will continue to draw attention to that as well right.

Alright, thank you.

Your next question is from Alethia young with Cantor Fitzgerald.

Hey, guys. Thanks for taking my question I. Just wanted you guys talked a little bit more about the moderate to severe psoriasis.

How you plan on kind of penetrating with commercial sales force you have especially in light of potential competition that may emerge over time with Bristol and then just also with US to program is that still underway of the combinations that you guys. Thanks.

unknown: Mohit, the contracts aren't necessarily on a schedule. We have some large networks where we negotiate annually, but we have a lot of smaller, what we call value-based accounts where we contract on a much more non-calendarized basis. So they're happening throughout the course of the year. And with respect to your question about reversal, are you asking me about price trends, or volume trends? Can you clarify that question? I mean, the trends. I mean, because there was a trend towards using more on-pro versus the PFS, given it is an at-home product. So do you think there could be some kind of reversal there as the pandemic subsides?

Maybe I'll just start very quickly.

Ship to yes, that's underway.

And we're continuing to work on that combination are more to come.

Murdo, yes annually.

I know they see us as I mentioned earlier in response to the question.

On the.

<unk>.

Two data that were recently presented.

We as I've mentioned in the past we have begun primary care promotion.

Four Oh Tesla in the currently labeled mild to moderate patient population.

<unk> has seen good response, there in terms of uptake with 11% tier ex year on year performance.

unknown: [inaudible]

<unk> for the quarter.

Murdo: Yeah, thank you for the clarification. Obviously, we're watching that. Clearly, the pandemic was stimulus for many oncologists to think more carefully about the GCSF treatment that they were going to use in order to help minimize the amount of provider interaction that patients would incur. What we have been doing in the meantime, though, is reinforcing that you actually can improve outcomes by using Long Acting GCSF and using OnPro in particular, so we have a promotional effort that I think is helping strengthen the volume demand curve.

We're pretty pleased with that evolution, what we are seeing us a slowdown in the psoriasis patient population in the newly diagnosed patient population in particular.

And we think this has a direct impact of COVID-19, causing patients with psoriasis us not to see their dermatologist, starting really at the beginning of the pandemic, but what's happened is the cumulative effect of this is starting to impact.

The patients that have passed through some of the topical options and.

We depend on bio naive patients for our growth. So we are definitely pre biologic option for dermatologists. So so we are watching that closely and we think that that could continue to create some softness in the pre biologic psoriasis patient market opportunity into <unk>.

Murdo: The only thing I will continue to point out, though, is that with competition comes some price erosion, and we have a new competitor entrant in that category in the Long Acting GCSF category, so we anticipate more net price negative evolution through the remainder of the year.

Geoffrey Christopher Meacham: Your next question is from Geoffrey Porges with SVB Leary.

Q2 with recovery thereafter, because we are seeing much more per.

Murdo: Thank you very much for the question. Murdo, could you discuss the issue of price? A pretty significant negative price effect. First of all, could you tell us whether that's all in the U.S. or whether it's U.S. and ex-U.S.

<unk> volume in dermatology offices in March and into April. So we think that things are recovering, but it will take a while for that cumulative effect of new patient softness to work its way through the market.

Murdo: And then secondly, since you, in the U.S., took significant price increases at the end of the year but still have negative price queues on queue, it looks like 8 or 9 percent, is this going to be a trend that persists throughout the year? And then, Bob, perhaps you could comment on what we should be modeling in terms of legislative or executive order changes to pricing going forward. Usually, you have your finger on the pulse in Washington. All right. Thanks, Geoff.

In terms of overall positioning in the market. We continue to think that our safety and efficacy profile as a very attractive option for patients and dermatologists as that first systemic agent pre biologic.

And I think really these days in rheumatology and dermatology physicians are much more aware of the different categories of options that they have in the different profiles of the different classes of drugs and I think that with recent data in the JAK category there'll be some.

Bob Bradway: Let me go first on the overall price evolution in the portfolio. We continue to believe that a mid-single-digit net negative price for the portfolio for the year is the right number. That's what we continue to see. What you know and what we experience probably more than some of our peer companies in the first quarter, given the nature of our portfolio, is more net negative price evolution because of patients renewing their benefits and going through benefit re-verification and hitting their kind of out-of-pocket resets.

Some speculation in some hesitancy to us a product like that take to as a first bio naive option to treat patients.

Hey, Eric Thanks, Let's go to the next question.

Our next question is from Dane Leon with Raymond James.

Okay.

Alright, Thank you for taking the questions and congrats on the update and the start to the year.

So the question for me just as a follow up to some of the tariff questions.

And really maybe since people have been asking about fairly specific things I think.

What everyone's trying to analyze and some of the updates if we're really only getting.

Bob Bradway: And so our co-pay assistance programs have more drag. We did activate more payer access at the end of last year for this. So we did have on some brands some increased payer coverage at the cost of some net price negative evolution. But we do anticipate Q1 being the lowest comparator, Q2 being a little better, and then Q3 and Q4 being better thereafter.

A longer term follow up on your pivot.

Pivotal data set at <unk>.

What's the team's view right now of the ability to move <unk> into the frontline setting in lung.

A lot of US had thought that you would need a combination successful combination with PD one to move into the frontline setting obviously, we havent seen you guys start a pivotal data set and you just said it might take longer to figure out that algorithm.

unknown: And Geoff, on Washington, I'm not sure whether executive order is the concern these days or whether it's something that's attached to reconciliation. If I had to guess, I'd say there's a greater risk of something being attached to reconciliation.

Alternatively, you go down the ship two pathway do you have a timeline for showing us ship two combination data.

And two is.

Is there an alternative path for getting us the tourists have been to the frontline lung setting that we should be thinking about that we might be missing on this call right now.

Thank you.

Thanks Dean.

unknown: Sharma, Jay Chowdhury, Anjum Rajan, Anjum Rajan, Anjum Rajan, Anjum Rajan,

In terms of potential frontline combinations I think a number of them that are being examined in the master protocol.

If we can enhance efficacy by multiple hits on the pathway could be feasible for example, the net combination.

unknown: [inaudible] Great, thank you. Your next question is from Alethea Young with Canter Fitch. Hey guys, thanks for taking my question. I just wanted you guys

The Egfr inhibitor combinations.

Unknown Attendee: Your next question is from Alethea Young with Canter Fitzgerald. Hey guys, thanks for joining us on the microphone.

And then as well as you've mentioned.

PD, one whether that is in combination or sequentially.

Unknown Attendee: Maybe I'll just start very quickly, Alethea, SHIP2, yeah, that's underway, and, you know, we're continuing to work on that combination. More to come, Murdo. Yeah, and Alethea, as I mentioned earlier in response to the question on the TIC2 data that were recently presented, we, as I've mentioned in the past, have begun primary care promotion for Otesla in the currently labelled mild to moderate patient population and have seen a good response there in terms of uptake, with 11% TRX year-on-year performance for the quarter, and we're pretty pleased with that evolution.

Yes.

For example to rely on the priming effect is a question that we're trying to answer.

Two I would also consider an additional hit on the pathway.

And would also fall into that grouping so.

I think we'll be guided by emerging data, but all of those would be potential avenues into earlier lines of therapy.

In addition.

Also potentially avenues into other indications such as colorectal cancer and some of the other solid tumors, where <unk> mutations occur.

Your next question is from Ronny Gal with Bernstein.

Unknown Attendee: What we are seeing is a slowdown in the psoriasis patient population, in the newly diagnosed patient population in particular, and we think this is a direct impact of COVID causing patients with psoriasis not to see their dermatologist, starting, you know, really at the beginning of the pandemic, but what's happened is the cumulative effect of this is starting now to impact the patients that have passed through some of the topical options, and, you know, we depend on bio-naive patients for our growth, so we are definitely a pre-biologic option for dermatologists, so we are watching that closely, and we think that that could continue to create some softness in the pre-biologic psoriasis patient market opportunity into Q2 with recovery thereafter, because we are seeing much more patient volume in dermatology offices in March and into April, so we think that things are recovering, but it will take a while for that cumulative effect of new patient softness to work its way through the market. In terms of overall positioning in the market, we continue to think that our safety and efficacy profile is a very attractive option for patients and dermatologists as that first systemic agent pre-biologic, and I think really, you know, these days in rheumatology and dermatology, physicians are much more aware of the different categories of options that they have and the different profiles of the different classes of drug, and I think that with recent data in the JAK category, there will be some speculation and some hesitancy to use a product like the

Good afternoon, and thank you for fitting me in two if I may 1st just.

Traditional sort of asking the question.

I guess, we saw some data at ACR by patient, having multiple escape mutations from the first one being when treated with a K rescue 12 day inhibitor and <unk>.

Was wondering if does that concern you that patient escapes so quickly with multiple mechanism.

That suggests that maybe two agents will not be not for us that part for the course.

What is expected.

Second we have seen some of your peers license, China developed and tested product to bring to the developed market.

Especially in oncology and I was wondering if you consider this strategy, especially as the Biosimilar players it seems to be a natural complementary strategy and if so where did you come out of that.

Maybe I'll start with the first part and then.

Have murdo address the second part yes.

Yes in terms of the mutational patterns that were recently reported.

I would say that biologically nothing that we thought surprised us based on everything we've learned about these pathways in the last 30 to 40 years and the potential mechanisms of resistance. This also points the way I think too specific.

Combinations that may in fact help to ameliorate those resistance patterns I will point out that we will be presenting.

In short order here also.

David comprehensive biomarker data, including mutational data and I think youll find that of.

Interest and that is certainly helping to guide our own thinking about the development program as well and Murdo you want to take the second half of the question. Yes, Ronny. We we continue to look globally for product opportunities to license and per boat.

Dane Vincent Leone: Your next question is from Dane Leone with Raymond James.

unknown: I thank you for taking the questions and congrats on the update and the start to the year. So the question for me, which is a follow up to some of those Tara Sib questions, is really, maybe since people have been asking about fairly specific things, I think what everyone's trying to analyze in some of the updates, if we're really only getting longer term follow up on your pivotal data set at ASCO, is, you know, what's the team's view right now of the ability to move Satorisib into the frontline setting and long?

The World and I think in oncology in particular, there have been some interesting deals done lately.

We obviously have a strong partnership already with a company based in China through Beijing.

And we continue to enjoy that partnership and co development that we have I would also say that given our global footprint Amgen really is an excellent.

Partner choice with our global capabilities in oncology and general Medicine. So.

So we are open to do business with Chinese companies Japanese companies global companies absolutely.

unknown: A lot of us had thought that you would need a combination, a successful combination with PD-1, to move into the frontline setting. Obviously, we haven't seen you guys start a pivotal data set, and you just said, you know, it might take longer to figure out that algorithm. Alternatively, you go down the SHIP-2 pathway. Do you, one, have a timeline for showing us SHIP-2 combination data?

Okay, Eric we're pushing up against the top of the hour. So we'll try to get to all of our questions, but when we bring on the next caller.

Our next question is from Carter Gould with Barclays.

Great. Good afternoon. Thanks for all the color today, maybe just.

Switching gears, a bit and moving to.

<unk>. It sounds like you are about to go back into the clinic can you maybe just give us some color on sort of the.

Changes to the protocol or dose escalation any any read through to the <unk>.

unknown: [inaudible]

The broader platform and just I guess.

David: Yeah, thanks, Dane. You know, in terms of potential frontline combinations, I think a number of them that are being examined in the master protocol, if we can enhance efficacy by multiple hits on the pathway, could be feasible. For example, the MEK combination, you know, the EGFR inhibitor combination, And then, as well, as you mentioned, PD-1, whether that is in combination or sequentially, for example, to rely on a priming effect, is a question that we're trying to answer.

Focus more specifically on day CMA with those changes comment on sort of your competitiveness in a increasingly competitive space. Thank you.

Yes Carter. Thanks for the question. So we do expect to begin dosing again, hopefully in the next few weeks or so.

As you intuitive this wood.

Just some of the <unk>.

Intra patient dose escalation that is typical with the use of bite molecules.

So.

We will be pushing pushing that forward.

David: SHIP-2, I would also consider an additional hit on the pathway and would also fall into that grouping. So I think, you know, we'll be guided by emerging data, but all of those would be potential avenues into earlier lines of therapy. In addition, they could also potentially be avenues into other indications, such as colorectal cancer and some of the other solid tumors where G12C mutations occur.

More broadly, obviously, we want to be able to deliver.

A program here that can offer something to patients and physicians that they otherwise might not have.

And we will continually assess the program.

Against that.

Trick more.

More broadly I'm.

I'm quite pleased with the progress we made on AMG 160, <unk> and AMG 757.

Unknown Attendee: Your next question is from Ronnie Gale with Bernstein.

And.

As always we're always.

David: Good afternoon, and thank you for fitting me in. To you, first, just the traditional sort of question. I guess we saw some data in ACR about a patient having multiple escape mutations from the first when treated with a KRS-C12C inhibitor. And I was wondering, does that concern you that the patient escapes so quickly with multiple mechanisms? Does that suggest that maybe two agents will not be enough? Or is that not par for the course? And you know, this is what was expected.

I'll provide a cautionary note about extrapolating extensively across programs because much of what we witness in the clinic is target.

And so all of these programs will have their idiosyncrasies that needed to be worked through as part of the development program.

Your next question is from Colin Bristow with UBS equities.

Hi, Good evening. Thank you. Thank you and then just a quick update from you guys on the business development priorities. What are your current areas of interest how are you thinking about deal size and just some overall commentary on how youre thinking about valuations in the space.

David: And so, second, we have seen some of your peers license Chinese-developed and tested products to bring to the developed market, especially in oncology. And I was wondering if you consider this strategy, especially as a similar player, this seems to be a natural complementary strategy. And if so, where do you come out on that?

Well Colin as you know.

Transacted two acquisitions in the first quarter one of the preclinical stage one of the phase III ready and I think that reflects the breadth of interest that we have we're continuing to look at acquisitions and licensing opportunities in our standard and areas of focus so.

In particular immunology inflammatory diseases cardiovascular diseases cancer are attracted to US and then we have very strong franchises and a few other therapeutic areas as you know in.

David: And maybe I'll start with the first part and then have Murdo address the second part. Yeah, in terms of the mutational patterns that were recently reported, I would say that biologically, nothing that we saw surprised us based on everything we've learned about these pathways in the last 30 to 40 years and the potential mechanisms of resistance. This also points the way, I think, to specific combinations that may, in fact, help to ameliorate those resistance patterns.

Migraine bone health in nephrology, so we look for commercial opportunities there as well.

That's helpful. Maybe just one quick question in terms of inflation degradation, obviously, you have a platform somewhere early yes.

Any interest in expanding your positioning in that space.

Murdo: I will point out that we will also be presenting, in short order, here also updated comprehensive biomarker data, including mutational data. And I think you'll find that of interest, and that is certainly helping to guide our own thinking about the development program as well.

Yes, as we've said before I think going forward, we would expect the.

Development of what we call the induced proximity platform to depend both on internal innovation and external partnerships and potentially acquisitions. So we're open to both we're making a lot of progress there and we will provide more detail a bit later.

Eric I think together, we have a couple more questions lined up so we'll take those remaining questions with apologies to to the audience that we're going over the allotted hour, let's skip the next question.

Our next question is from Robin Cornwell Smith with true.

Murdo: Yes, Ronnie, we continue to look globally for product opportunities to license and promote around the world. And I think in oncology, in particular, there's been some interesting deals done lately. We obviously have a strong partnership already with a company based in China through Beijing, and we continue to enjoy that partnership and the co-development that we have. I would also say that given our global footprint, Amgen really is an excellent partner choice with our global capabilities in oncology and general medicine. So, we're open to doing business with Chinese companies, Japanese companies, and global companies. Absolutely not.

Thanks, guys. So you addressed a little bit of the moderate severe pressure on the competition for Tesla could you again addressed a little bit more now that we have more granular data from <unk> and others.

On the topical do you think the topical being cheaper might push out some of the uptake in the biologics for Tesla and then if you want to answer that one throat went out here. Your wanted US first did you Artur application for oncology with all of the FCA controversy development can you just tell us like how that's going is it is it we're seeing us.

Normalizing.

I was wondering how that how that application process will go because that could be the faster way to market for a lot of new trials.

Erica: Okay, Erica, we're pushing up against the top of the hour, so we'll try to get to all of our questions, but why don't we bring on the next caller?

I'm trying to get them both quickly alright Robin look we.

Carter Gould: Okay, our next question is from Carter Gould with Barclays.

We think that there's obviously a role for topical us to play for patients with low body surface area involvement of their disease when it starts to become.

David: Great, good afternoon, thanks for all the color today. Maybe just switching gears a bit and moving to BCMA, it sounds like you're about to go back into the clinic. Can you maybe just give us some color on sort of the changes to the protocol or dose escalation, any read-through to the broader platform, and just, I guess, focus more specifically on BCMA with those changes, and comment on sort of your competitiveness in an increasingly competitive space? Thank you.

Broader surface area or an awkward places on the patient's body, then theyre looking for a systemic agent and Theyre looking for a safe and effective one and that's really where we think the mild to moderate opportunity is for <unk>.

We're not even considering.

The millions of patients out there with mild to moderate we're looking at about 40% to 50% addressable patient population. So we're giving at least half the market as a topical market assuming the other half would be addressable with Anoro day.

David: Yeah, Carter, thanks for the question. We do expect to begin dosing again, hopefully, in the next few weeks or so. You know, as you intuited, this would adjust some of the, you know, intrapatient dose escalation that is typical with the use of bite molecules. And so, you know, we'll be pushing, you know, pushing that forward. You know, more broadly, obviously, we want to be able to deliver a program here that can offer something to patients and physicians that they otherwise might not have.

Yep.

In terms of our tour or real time oncology review, what that does us permit submission of tranches of data.

As you move through the submission process as opposed to waiting.

Submitting either a complete file all at once or very large chunks of a file we've had very productive interactions with the FDA and in our view.

<unk> process has worked quite nicely here in the longer term quite frankly, I think that this is the way of the future not only in oncology, but across therapeutic areas for more real time submission of data probably from the inception of development programs.

David: And, you know, we'll continually assess the program against that metric. But, more broadly, I'm quite pleased with the progress we made on AMG 160 and AMG 757. And I, as always, would always provide a cautionary note about extrapolating extensively across programs because much of what we witness in the clinic is target dependent. And so all of these programs will have their idiosyncrasies that need to be worked through as part of the development.

Eric kind of uptick two last questions. Please.

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

Hey, Thanks for squeezing me in a question on pathology Mab recently heard from our K well, some thoughts with us actually could be a competitive some of.

The other biologics.

In the high Eosinophil group not just competitive in.

High unmet needs.

Colin Nigel Bristow: Your next question is from Colin Bristow with UBS Equities.

Clinical market I was just wondering when that data does come out that full publication does come out really what.

unknown: Just a quick update from you guys on the business development priorities, what are your current areas of interest, how are you thinking about deal size, and just some overall thoughts.

We should be looking for in these high voltage <unk> for funds of competitiveness there. Thank you.

Yeah.

Thanks, Kevin.

As we've reported as you saw and we will be providing some data updates on additional analyses on the navigator phase III trial at the American Thoracic Society meeting.

unknown: [inaudible] Well, Colin, as you know, we've

In a few weeks now.

unknown: Well, Colin, as you know, we've transacted two acquisitions in the first quarter, one at the preclinical stage, and one at the phase three ready stage, and I think that reflects, you know, the breadth of interest that we have. We're continuing to look at acquisitions and licensing opportunities in our stated areas of focus. So, you know, in particular, immunology, inflammatory diseases, cardiovascular diseases, cancer, are attractive to us. And then we have very strong franchises in a few other therapeutic areas, as you know, and in migraine, bone health, and nephrology. So we look for commercial opportunities.

Across the board.

We saw.

Efficacy that we think is consistent with first line use saw its important to understand that.

There are many patients with severe uncontrolled asthma or who have disease.

That is seeking another treatment right now, meaning they are not controlled with currently available therapies and so regardless of eosinophil count.

We think that the the clinical profile of this molecule is quite attractive and my view continues to be that this is just going to be a really important medicine in asthma for <unk> patients.

Eric Let's take one last question.

And your final question comes from Cory <unk>.

unknown: Yeah, as we've said before, you know, I think going forward, we would expect the development of what we call the induced proximity platform to depend both on internal innovation and external partnerships and, potentially, acquisition. So we're, you know, we're open to both. We're making a lot of progress there, and we'll provide more detail a bit later. Eric, I gather we have a couple more questions lined up. So we'll take those remaining questions with apologies to the audience that we went over the allotted hour. Let's get the next question.

With J P. Morgan.

Updated <unk> ability to penetrate the blood brain barrier and do you see this as a potential future source of differentiation, one way or the other in the K rescue.

Yes, Cory. Thanks, So quickly. So we are actually studying specifically Ah lunar kras in patients with brain metastases I think the clinical data will be definitive here and once we have them.

<unk>, a large enough dataset will present that but.

It's full speed ahead to answer that question.

Okay well. Thank you all for your for your patience and for dialing into the call today.

Robyn Kay Shelton Karnauskas: Your next question is from Robyn Karnauskas with Truist.

Mind, you as always that Arvind and his team will be around for several hours still if you had other questions as you didn't get answered, but we appreciate your support and look forward to getting back with you in July.

unknown: Thanks, guys. You addressed a little bit of the moderate to severe pressure on the competition for Tesla. Could you, again, address a little bit more now that we have more granular data from Tepeneroff and others on the topicals? Do you think the topicals, being cheaper, might push out some of the uptake of the biologics for Tesla? And then, if you want to answer that one, just throw one out here.

Thank you everybody.

This concludes amgen's first quarter 2021 financial results Conference call you may now disconnect.

Okay.

[music].

unknown: You're one of the first to do our tour application for oncology with all the FDA controversy development. Can you just tell us how that's going? Is it proceeding as normal? We're all wondering how that application process will go, because that could be the faster way to market for a lot of new drugs. Thanks. I'll try to get them both quickly.

unknown: Let's try to get them both quickly. All right, Robyn, look, we think that there's obviously a role for topicals to play for patients with low body surface area involvement in their disease. When it starts to become, you know, a broader surface area or in awkward places on the patient's body, then they're looking for a systemic agent, and they're looking for a safe and effective one. And that's really where we think the mild to moderate opportunity is for Otesla.

Yes.

Okay.

Okay.

[music].

unknown: And we, you know, we're not even considering the millions of patients out there with mild to moderate conditions. We're looking at about a 40 to 50% addressable patient population. So we're giving at least half the market as a topical market, assuming the other half would be addressable with an oral. Yeah, and in terms of RTOR or real-time oncology review, what that does is permit submission of tranches of data as you move through the submission process, as opposed to waiting and submitting either a complete file all at once or very large chunks of a file.

unknown: We've had very productive interactions with the FDA, and in our view, the RTOR process has worked quite nicely here in the longer term, quite frankly. You know, I think that this is the way of the future, not only in oncology but across therapeutic areas for more real-time submission of data, probably from the inception of development programs. Erika, we have two last questions.

Geoffrey Christopher Meacham: Your next question is from Kenan McKay with RBC Capital Markets.

unknown: that this actually could be as competitive as some of the other biologics in asthma in the high eosanafil group, not just competitive in the high I'm at need, low eosinifil market. Just wondering when that data does come out, that full publication does come out, really what we should be looking for in these high Eosinephal patients for signs of competitiveness there. Thank you. Yeah. No, thanks, Kenon

unknown: And, you know, as we've reported, as you saw, and we'll be providing some data updates, additional analyses on the Navigator, Phase 3 trial at the American Therathic Society meeting in a few weeks now, across the board, we saw efficacy that we think is consistent with first-line use. It's important to understand that there are many patients with severe uncontrolled asthma who have a disease that is seeking another treatment right now, meaning they are not controlled with currently available therapies.

unknown: And so regardless of the acinophil count, you know, we think that the clinical profile of this molecule is quite attractive. And, you know, my view continues to be that this is just going to be a really important medicine in asthma for patients. Erika, we have one last question. Your final question comes from Corey Kasimow with J.P. Morgan.

[music].

Operator: Operator, your final question comes from Corey Kasimov with J.P. Morgan.

unknown: Yeah, Corey, thanks. Quickly, you know, so we're actually studying specifically lumacrasts in patients with brain metastases. I think the clinical data will be definitive here. And once we've amassed a large enough data set, we'll present that, but it's full speed ahead to answer that question.

Bob Bradway: Okay, well, thank you all for your patience and for dialing in to the call today. I'll remind you, as always, that Arvind and his team will be around for several hours still if you have other questions that you didn't get answered. But we appreciate your support and look forward to being back with you in July. Thanks.

unknown: Jalali. Thanks. Thank you, everybody.

unknown: This concludes Amgen's first quarter 2021 financial results conference call. You may now disconnect.

unknown: I'm A Big Man I Love You So Much More Than You Can Ever Think Of I Can I Have A Big Man And He Likes Me So Much More Than You Can Ever Think Of I Can I Have A Big Man And He Likes Me So Much More Than You Can Ever Think Of I Can I Have A Big Man And He Likes Me So Much More Than You Can Ever Think Of I Can I Have A Big Man And He Likes Me ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? and so on the way. Thank you. Thank you.

Erica: My name is Erica, and I will be your conference facilitator today for Amgen's first quarter 2021 financial results conference call. All lines have been placed on mute to prevent any background noise.

Arvind Sood: 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 participate, we would like to request that you limit yourself to asking one question during the Q&A session. To ask a question, please press the star and 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: Erica, thank you. Good afternoon, everybody.

Arvind Sood: Welcome to our Q1 call. I think the two key themes for this quarter are continued focus on volume-driven growth and pipeline advancement. Lots to cover, but we'll do our best to stick to an efficient format of limited prepared comments and addressing your one best question. 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 statements. 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. Okay, Bob?

Bob Bradway: Okay. Thank you, Arvind. And hello, everyone, and thank you for joining our call. We've had a busy start to 2021 and a first quarter that's something of a mirror image to what we experienced a year ago. Last year, if you recall, we came out of the gate with a very strong January and February and then started to really feel the impact of the pandemic in March. This year, especially in the U.S., it was almost the reverse.

Bob Bradway: We felt the impact of the pandemic in January and February, and we began to see a recovery in March, a trend that seems to be holding in April as well. Setting aside the pandemic, we executed effectively in the first quarter, and this is reflected in the strong competitive performance of our brands globally, our strong biosimilars showing, the rapid progress of our lead pipeline molecules, and the addition of an attractive phase three ready molecule in oncology.

[music].

Bob Bradway: All together, we remain confident in our full year outlook. We're fortunate to have a diverse portfolio of newer products that continue to show strong volume growth. PAPA, for example, delivered thirty-six percent volume growth in the first quarter. It remains the clear leader of the PCSK9 market globally and will serve as a strong

unknown: Choudhury, and we'll soon reach the milestone of one million patients.

Bob Bradway: We are also the global leader in bone health, with Prolia and Avenidae generating double-digit volume in the quarter. Our industry-leading portfolio of biosimilars is annualizing above the $2 billion mark, and I would remind you that we have three additional biosimilars in Phase III development and look forward to a flow of new launch opportunities for these and Amgevita over the next few years. As we've shared with you many times in the past, we're active in business development, looking to complement our internally developed innovation.

unknown: [inaudible]

Bob Bradway: As you know, one of the molecules we acquired in that deal, memrituzumab, was granted breakthrough therapy designation by the FDA.

Bob Bradway: More than 1 million new gastric cancer cases are diagnosed annually, and the disease is particularly prevalent in the Asia-Pacific region, which we've said previously will account for approximately 25% of our growth over the next decade.

My name is Erica and I will be your conference facilitator today for Amgen's first quarter 2021 financial results Conference call. All lines 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.

Bob Bradway: Femortuzumab is now our third late-stage clinical medicine to be granted breakthrough therapy status.

Everyone has a chance to participate we would like to request that you limit yourself to asking one question during the Q&A session.

Bob Bradway: Sotiracib, for which the trade name Lumicrous has now been provisionally approved for use in the U.S.

unknown: U.S., and Teza Pelliamab also has earned that breakthrough therapy distinction. With a strong balance sheet, healthy cash flows, and a proven ability to integrate, we'll continue to...

Ask a question. Please 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.

Eric. Thank you good afternoon, everybody welcome to our Q1 call I think the two key themes for this quarter. Our continued focus on volume driven growth and pipeline advancement lots to cover but we will do our best to stick to inefficient format of limited prepared comments and addressing your one best question.

unknown: Bansal. Thank you. Thank you. Thank you.

Bob Bradway: [inaudible] Before I turn things over to our CFO, Peter Griffith, I want to thank my Amgen colleagues for their continued commitment to serving patients around the world and delivering results for our stakeholders. I look forward to our Q&A session a little later on in our call. But for now, over to you, Peter. Thank you, Bob. I would like to take a few moments to reflect on the strong fundamentals of the business and further reaffirm our full commitment.

The slides have been posted and just a quick reminder, that we'll use non-GAAP financial measures in our presentation and some of the statements will be forward looking statements are 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, Bob day. Thank you Arvind.

Peter H. Griffith: Our Full Year Revenue and Non-GAAP EPS Guide. Let me first confirm our predictable consistent capital allocation hierarchy as seen in our Q1 activity.

And Hello, everyone and thank you for joining our call.

We've had a busy start to 2021.

And our first quarter Thats something of a mirror image to what we experienced a year ago.

Peter H. Griffith: It always begins with investing in internal innovation. LumaCraft and TeziTeleMap, both internally discovered, and each granted a grant and breakthrough therapy designation, are excellent examples of this. We also patiently pursue external business development opportunities that clear our hurdle rate and that are consistent with our areas of therapeutic focus, which we are confident of integrating into Amgen efficiently and effectively on a timely basis. We allocated $2 billion of our shareholders' capital to the 5 Prime acquisition, paid in the second quarter, and have committed additional R&D funding to pursue other indications.

Last year, if you recall, we came out of the gate with a very strong January and February and then started to really feel the impact of the pandemic in March.

This year, especially in the US it was almost the reverse we felt the impact of the pandemic in January and February and we began to see a recovery in March a trend that seems to be holding in April as well.

Setting aside the pandemic, we executed effectively in the first quarter and this is reflected in the strong competitive performance of our brands globally.

Our strong biosimilar showing.

The rapid progress of our lead pipeline molecules and the addition of an attractive phase III ready molecule in oncology.

unknown: for the lead molecule, BMO. However, our capital expenditures remain

Together, we remain confident in our full year outlook.

unknown: Srinivas Jain, Anirudh Singh, Anirudh Singh, Anirudh Singh, Anirudh Singh, Anirudh Singh,

We're fortunate to have a diverse portfolio of newer products that continue to show strong volume growth for <unk>.

unknown: Assisting with the Enabling Carbon Neutrality by 2020.

For example delivered 36% volume growth in the first quarter.

unknown: Ramanathan, and the Digitization Imperative. We continue to return capital to our shareholders. First, we pay dividends of $1.76 per share in the quarter, representing a 10% increase from 2020. This year marks our 11th year of dividends, with meaningful increases in each of those years. Second, we repurchased 3.7 million shares in the first quarter at a cost of roughly $865 million. Finally, our capital allocation hierarchy always builds on our efficient capital structure, which results in an optimal weighted average cost of capital.

It remains the clear leader of the PCF canine market globally and will soon reach the milestone of 1 million patients served.

We're also the global leader in bone health with Prolia, and <unk> entity generating double digit volume in the quarter.

Our industry, leading portfolio of Biosimilars is annualizing above the $2 billion, Marc and I would remind you that we have three additional biosimilars in phase III development and look forward to a flow of new launch opportunities for these and Amgen Peter over the next few years.

As we've shared with you many times in the past we're active in business development looking to complement our internally developed innovation with compelling external opportunities and our recent acquisition of five Prime Therapeutics is a good example of that.

Peter H. Griffith: Now I will briefly walk through our first quarter financial results. Recall that in 2021, we are now comparing to our recast 2020 results that exclude the impact of fair value adjustments to equity investments that were historically included in non-GAF OI&E. In Q1, revenues decreased 4%. Historically, first quarter sales have been the lowest as a percentage of the full year. As we entered 2021, we knew that COVID would likely introduce some variability.

As you know one of the molecules we acquired in that deal <unk> was granted breakthrough therapy designation by the FDA as a first line therapy for a subset of patients with gastric cancer.

More than 1 million new gastric cancer cases are diagnosed annually in the disease is particularly prevalent in the Asia Pacific region, which we've said previously we will account for approximately 25% of our growth over the next decade.

Peter H. Griffith: And as the quarter progressed, and we saw a continuing cumulative effect of COVID cases on prescribing patterns, we anticipated that Q1 would be more negatively impacted, which led us to disclose in March that it would be moderately below the 2020 percentage of the full year. First quarter sales benefited from 4% volume growth. Looking back to Q1 of 2020, we recorded approximately $150 million of favorable changes to estimated sales deductions, creating a negative impact on year-over-year growth.

<unk> is now our third late stage clinical medicine to be granted breakthrough therapy status, joining sooner acid for which the trade name <unk> has now been provisionally approved for use in the us and tend to tell you mab.

Also as urns that breakthrough therapy distinction.

With a strong balance sheet healthy cash flows and our proven ability to integrate we will continue to look for external opportunities that strengthen us in our stated areas of focus.

Before I turn things over to our CFO, Peter Griffith I want to thank my Amgen colleagues for their continued commitment to serving patients around the world and delivering results for our stakeholders I look forward to our Q&A session. A little later in our call but for now over to you Peter.

Peter H. Griffith: Anderson, and Q1 2021. As we get underway with the second quarter, we expect there to be some continuing cumulative COVID impacts. While we expect to see improvements in the rate of recovery, that recovery will be more heavily weighted than in the second half of the year. Total non-GAAP operating expenses for the quarter increased 2% year-over-year. For the full year, we continue to expect cost of sales as a percent of product sales to be 16 to 17 percent.

Thank you Bob I would like to take a few moments to reflect on the strong fundamentals of the business and further to reaffirm our full year revenue and non-GAAP EPS guidance.

First confirm our predictable consistent capital allocation hierarchy as seen in our Q1 activity.

It always begins with investing in internal innovation Pneumograph impaired vitale map, both internally discovered and each granted breakthrough therapy designation.

Peter H. Griffith: Effective Q2 2021, cost of sales will increase as a percent of product sales in connection with our first shipments of antibodies to Lily. Recall that revenue from shipments of these antibodies will be recorded in other revenues.

Excellent examples of this.

We also patiently pursue external business development opportunities that clear our hurdle rate and that are consistent with our areas of therapeutic focus and which we are confident of integrating into amgen efficiently and effectively on a timely basis, we allocated $2 billion of our shareholders' capital to the five prime acquisition.

Peter H. Griffith: For the full year, we expect R&D spend to increase as our innovative pipeline continues to progress, which now includes FEMA from the Five Prime acquisition as well as the Rodeo acquisition. And for the full year, we expect SG&A spend to decline as we continue our focus on the digitization imperative.

The second quarter and have committed additional R&D funding to pursue other indications, but the lead molecule <unk>.

Our capital expenditures remain a high priority, including investments in our industry leading protein manufacturing.

Peter H. Griffith: Non-GAAP OI&E was a net $375 million expense in Q1. This is unfavorable by $79 million on a year-over-year basis. Due to the recording of our portion of Beijing's loss this quarter. However, please recall that the recognition of Beijing's results did not start until Q2 2020. The effects year-over-year of the adjustments and sales deductions, combined with the recognition of the Beijing results, totaled about 29 cents in decreased EPS on a comparison basis for Q1'21 and explain a large portion of the 12% decline in EPS year over year.

Our ESG initiatives, including enabling carbon neutrality by 2027 and Digitization imperative.

We continue to return capital to our shareholders first we paid dividends of $1 76 per share in the quarter, representing a 10% increase from 2020.

This year marks our 11th year of dividends with meaningful increases in each of those years.

Second we repurchased three 7 million shares in the first quarter net cost of roughly $865 million.

Finally, our capital allocation hierarchy always builds on our efficient capital structure, which results in an optimal weighted average cost of capital.

Now I will briefly walk through our first quarter financial results.

Recall that in 2021, we are now comparing to a recast 2020 results that exclude the impact of fair value adjustments to equity investments.

Peter H. Griffith: Now turning to the outlook for the business for 2021. Based on underlying market dynamics and our investment plan, we are reaffirming our 2021 guidance with a revenue range of $25.8 to $26.6 billion and a non-GAAP EPS range of $16 to $17. Important additional points to consider as you model the remainder of 2021. We are providing more specific quarter-over-quarter guidance given the unprecedented continuing cumulative COVID impacts on the operating environment.

Were historically included in non-GAAP <unk>.

In Q1 revenue decreased 4%.

Historically first quarter sales have been the lowest quarter as a percentage of the full year. As we entered 2021, we knew that COVID-19 would likely introduce some variability and as the quarter progressed and we saw a continuing cumulative effects of COVID-19 cases on prescribing pattern, we anticipated that Q1 would be <unk>.

More negatively impacted which led us to disclose in March that it would be moderately below 2000, twenty's percentage of the full year.

First quarter sales benefited from 4% volume growth looking back to Q1 of 2020, we recorded approximately $150 million of favorable changes to estimated sales production, creating a negative impact on year over year growth comparison in Q1 2021 as.

unknown: But we do not expect to provide such guidance on an ongoing basis.

As we get underway with the second quarter, we expect there to be some continuing cumulative COVID-19 impact while we expect to see improvements in the rate of recovery that recovery will be more heavily weighted to the second half of the year.

unknown: We see the recovery from COVID-19 more heavily weighted to the second half of the year, and for the second quarter, we expect total revenues to grow between 7% and 10% sequentially from the first quarter. We continue to expect full-year non-GAAP operating expenses to increase by about 7% over last year. With an operating margin of roughly 50%, which includes operating expenses for Five Prime and Rodeo. Historically The Q2 quarter-over-quarter operating expense increase was about 10%.

Total non-GAAP operating expenses for the quarter increased 2% year over year.

For the full year, we continue to expect cost of sales as a percent of product sales to be 16% to 17%.

Effective Q2, 2021 cost of sales will increase as a percent of product sales in connection with our first shipments of antibodies to Lilly.

Recall that revenue from shipments of these antibodies will be recorded in other revenue.

For the full year, we expect R&D spend will increase as our innovative pipeline continues to progress, which now includes bema five prime acquisition as well as the rodeo acquisition.

unknown: But in the second quarter this year, we expect quarter-over-quarter operating expenses to increase in the mid-

And for the full year, we expect SG&A spend to decline we continue our focus on Digitization imperative.

unknown: For the full year, we continue to anticipate non-GAFO I&E to be a net expense in the range of $1.3 to $1.5 billion. Our capital expenditures guidance remains unchanged at $900 million. And based on our confidence in the long-range outlook of the business, we are raising the upper end of our share repurchase range to $5 billion for 2021 versus prior guidance of $4 billion. So our range for share repurchases in 2021 is now $3 to $5 billion.

Non-GAAP <unk> was a net $375 million expense in Q1.

This is unfavorable by $79 million on a year over year basis due.

Due to the recording of our portion of Beijing block this quarter.

Recall the recognition of Beijing results did not start until Q2 2020.

The effects year over year of the adjustments in sales production combined with the recognition of the Beijing results totaled about 29 and decreased EPS on a comparison basis for Q1, 'twenty one and.

And explain a large portion of the 12% decline in EPS year over year.

Now turning to the outlook for the business for 2021.

Based on underlying market dynamics and our investment plan, we are reaffirming our 2021 guidance with a revenue range of 25 eight to $26 6 billion.

unknown: Additionally, we're updating our non-GAAP tax rate guidance to 13.5 to 14.5 percent versus prior guidance of 13 percent to 14 percent. My confidence is strong in the long-term outlook for Amgen, given the strength of the business.

And our non-GAAP EPS range of 16 to $17.

Important additional points to consider as you model the remainder of 2021.

We are providing more specific quarter over quarter guidance given the unprecedented.

Peter H. Griffith: Shukla, and the strength of our outstanding and dedicated team of 23,000 plus colleagues that deliver care every day to patients and all

Continuing cumulative COVID-19 impacts on the operating environment, but.

But we do not expect to provide such guidance on an ongoing basis.

unknown: and also deliver long-term growth to our shareholders. This concludes the financial update. I'll turn it over to Murdo. Murdo?

We see the recovery from COVID-19, more heavily weighted to the second half of the year.

And for the second quarter, we expect total revenue to grow between 7% and 10% sequentially from the first quarter.

Murdo: Thanks, Peter. First quarter product sales declined 5% year-over-year. Volumes grew 4%, driven by double-digit growth for a number of products, including Prolia, Repatha, Invasi, and Kenjinji. However, net selling price declined 7%, and the year-over-year comparison was negatively affected by 2% due to a benefit in Q1 2020 from approximately $150 million of changes to estimated sales deductions that did not reoccur to the same magnitude in Q1 of 2021. In the first quarter, the cumulative effect of the COVID pandemic on missed patient visits and diagnoses impacted our business.

We continue to expect full year non-GAAP operating expenses to increase by about 7% over last year.

With an operating margin of roughly 50%, which includes operating expenses for five prime and rodeo <unk>.

Historically.

The Q2 quarter over quarter operating expense increase is about 10%.

But in the second quarter. This year, we expect quarter over quarter operating expenses to increase in the mid teen percentage range, reflecting the impact of our Lilly COVID-19 antibody manufacturing agreement.

Investments for growth, including the five prime acquisition, as well as increasing activity level, including launch preparation.

For the full year, we continue to anticipate non-GAAP <unk> to be a net expense in the range of one three to $1 5 billion.

Our capital expenditures guidance remains unchanged at $900 million.

And based on our confidence in the long range outlook of the business. We are raising the upper end of our share repurchase range to $5 billion for 2021 versus prior guidance of $4 billion.

So our range for share repurchases in 2021 is now $3 billion to $5 billion.

Murdo: January and February were clearly affected by post-holiday COVID spikes, and March showed demand improvement across most brands, which has continued into April. Despite the impact of the pandemic, our teams have found solutions to address the continuity of care, stabilizing our continuing patient volume. We also saw improvement in customer-facing execution throughout the quarter across all communication channels, including face-to-face and virtual activities.

Additionally, we are updating our non-GAAP tax rate guidance to 13, five to 14, 5% versus prior guidance of 13% to 14%.

My confidence is strong in the long term outlook for Amgen, given the strength of the business.

And the strength of our outstanding and dedicated team of 23000, plus colleagues that deliver every day to patients and also deliver long term growth to our shareholders.

This concludes the financial update I will turn it over to Murdo murdo.

<unk>.

Murdo: We expect some COVID-19-related disruptions still in the second quarter, but a steady recovery thereafter. I'll now review some product details, beginning with our innovative portfolio. In bone health, Prolia grew 16% year-over-year, recording over $500 million in U.S. sales for the first time. As a majority of osteoporosis patients in the U.S. have been vaccinated and diagnosis rates are at approximately 90% of pre-COVID-19 levels, we're confident in Prolia's continued growth in 2021.

Thanks, Peter first quarter net product sales declined 5% year over year volumes grew 4% driven by double digit growth for a number of products, including Prolia, <unk> and vaccines and Tianjin.

Net selling price declined 7% in the year over year comparison was negatively affected by 2% due to a benefit in Q1 2020 from approximately $150 million of changes to estimated sales deductions.

That did not reoccur to the same magnitude in Q1 of 2021.

In the first quarter of the cumulative effect of the COVID-19 pandemic on missed patient visits and diagnoses impacted our business January and February were clearly affected by post holiday COVID-19 spikes in March showed demand improvement across most brands, which has continued into April.

Murdo: Evenity sales increased 7% year-over-year driven by strong volume growth. Given the severe impact of fractures on the lives of post-menopausal women, Ivanity provides an excellent therapy to build bone first, which should then be followed by treatment with prolio.

Despite the impact of the pandemic our teams of science solutions to address the continuity of care stabilizing our continuing patient volume.

We also saw improvement in customer facing execution throughout the quarter across all communication channels, including face to face and virtual activities.

Murdo: Repatha Sales increased 25% year-over-year to a quarterly sales record of $286 million, driven by 36% volume growth, and we maintain global leadership in the PCS K-9 class. Sales outside the U.S. grew by 40 percent, driven by strong patient demand. In the U.S., we continue to see strength in new patient starts, with new-to-brand prescriptions growing 54% quarter-over-quarter, helped by favorable Pharmacy Benefit Manager formulary changes. Volume growth in the U.S. demonstrates that we've made good progress against our strategy to provide Repatha at an affordable price to patients, particularly those with Medicare Part D coverage. This acceleration in Medicare Part D growth has increased our exposure to the so-called donut hole, which creates some negative impact on overall net price.

We expect some COVID-19 related disruptions still in the second quarter with steady recovery thereafter.

I'll now review some product details beginning with our innovative portfolio.

In bone health Prolia grew 16% year over year recording over $500 million of U S sales in the us for the first time.

As the majority of osteoporosis patients in the U S have been vaccinated in diagnosis rates are at approximately 90% of pre COVID-19 levels. We're confident in Prolia as continued growth in 2021.

<unk> sales increased 7% year over year, driven by strong volume growth.

Given the severe impact of fractures on the lives of post menopausal women US entity provides an excellent therapy to build bone first which should then be followed by treatment with prolia.

Murdo: We remain confident in our ability to grow Repatha globally to address the significant unmet medical need for treating high-risk cardiovascular patients, next to Amavig, which remains the market leader in the highly competitive CGRP class. Amavig volumes grew 20% year-over-year in the first quarter, with a 45% average total prescription share and 38% average new-to-brand prescription share. However, year-over-year net selling price declines were primarily driven by increased rebates to maintain patient access. Unfortunately, millions of patients suffering from migraine are suboptimally treated with older, less effective treatments.

<unk> sales increased 25% year over year to a quarterly sales record of $286 million driven by 36% volume growth and we maintained global leadership in the Pcs canine class sales.

Sales outside the us grew by 40% driven by strong patient demand in.

In the US we continue to see strength in new patient starts with new to brand prescriptions growing 54% quarter over quarter helped by favorable pharmacy benefit manager formulary changes.

U S volume growth demonstrates that we've made good progress against our strategy to provide repass I don't know affordable price to patients, particularly those with Medicare part D coverage.

Murdo: Given the head-to-head data we've generated showing Amovig's superiority against topiramate, we're confident we can help many more patients suffering from chronic migraines. Returning to our inflammation portfolio, where Otesla has demonstrated a robust safety and efficacy profile with over six years of real-world experience in the market, with more than 500,000 patients treated globally. Enbrel, similarly, has served millions of patients globally since 1998. But Tesla's sales were $476 million in the quarter.

This acceleration in Medicare part D growth has increased our exposure to the so called donut hole, which create some negative impact on overall net price.

We remain confident in our ability to grow <unk> globally to address the significant unmet medical need in treating high risk cardiovascular patients.

Next to aim a day, which remains the market leader in the highly competitive <unk> class <unk> volumes grew 20% year over year in the first quarter with a 45% average total prescription share and 38% average new to brand prescription share.

Murdo: Volume growth was 9%, driven primarily by 11% total prescription growth in the US. Otesla remains the market-leading branded systemic medication for psoriasis with an approximately 30% share of first-line treatment. However, new-to-brand prescription volume remained flat as COVID-19 continued to suppress the diagnosis and treatment of psoriasis patients. Year-over-year growth was also negatively impacted given the pandemic-related inventory stocking in Q1 of 2020.

Year over year net selling price declined primarily driven by increased rebates to maintain patient access.

Unfortunately millions of patients suffering from migraine or sub optimally treated with older less effective therapies.

Given the head to head data, we've generated showing analytic superiority against Topiramate. We're confident we can help many more patients suffering from chronic migraine.

Turning to our inflammation portfolio, whereas Tesla has demonstrated a robust safety and efficacy profile with over six years of real world experience in market with more than 500000 patients treated globally. Enbrel. Similarly has served us millions of patients globally since 1998.

Murdo: Otesla has more than 90% commercial pair coverage in the U.S. without requiring a biological step and is an affordable, safe, and efficacious option for psoriasis and psoriatic arthritis patients. We see attractive growth opportunities for OTESLA as the pandemic recovery progresses. In addition, geographic expansion and the anticipated approval later this year of the mild to moderate psoriasis indication will contribute to future OTESLA growth. In 2021, year-over-year comparisons for Enbrel are adversely impacted by $255 million of favorable estimated sales deductions that were recorded in 2020, 115 million of which were in Q1 of 2020.

But tesla sales were $476 million in the quarter volume growth was 9% driven primarily by 11% total prescription growth in the U S.

Oh Tesla remains the market, leading branded systemic medication for psoriasis with an approximately 30% share of first line treatment. However.

However, new to brand prescription volume remained flat as COVID-19 continues to suppress the diagnosis and treatment of psoriasis patients.

Year over year growth was also negatively impacted given pandemic related inventory stocking in Q1 of 2020.

So Tesla has more than 90% commercial payer coverage in the us without requiring a biological step and us and affordable safe and efficacious options for psoriasis and Psoriatic arthritis patients.

We see attractive growth opportunities for Tesla as the pandemic recovery progresses. In addition, geographic expansion and the anticipated approval later this year of the mild to moderate psoriasis indication will contribute to future Oh Tesla growth.

Murdo: In the quarter, Embraille sales decreased 20% year over year with declines in both unit volume and net selling price. Moving forward, we expect volume and net price trends to continue. Parsibeth sales decreased 55% year-over-year, driven by 65% volume declines.

In 2021 year over year comparisons for Enbrel are adversely impacted by $255 million of favorable estimated sales deductions that were recorded in 2020 $115 million of which were in Q1 of 2020.

In the quarter Enbrel sales decreased 20% year over year with declines in both unit volume and net selling price.

Moving forward, we expect volume and net price trends to continue.

Part of the sales decreased 55% year over year, driven by 65% volume declines with partial <unk> inclusion in the end stage renal disease bundle in the U S. We have seen dialysis clinics quickly implement new treatment protocols switching patients from <unk> to generic cinacalcet.

Murdo: With Parsibeth's inclusion in the end-stage renal disease bundle, in the U.S., we have seen dialysis clinics quickly implement new treatment protocols, switching patients from Parsibeth to generic Sinocalcet. Moving to biosimilars, Q1 sales were $570 million, driven by strong volume growth, which was partially offset by declines in net selling price. We continue to hold leading biosimilar shares in Europe for Amgevita and in the US for Imvasi and Kanjinti, where we saw average shares of 50% and 43%, respectively, in Q1. For the remainder of the year, we expect biosimilar volume growth to be offset by declines in net selling prices due to increased competition.

Switching to Biosimilars Q1 sales were $570 million driven by strong volume growth.

Which was partially offset by declines in net selling price. We continue to hold leading biosimilar shares in Europe for Amgen Vita and in the U S friends ICM Tien Tsin T, where we saw average shares of 50% and 43% respectively in Q1.

For the remainder of the year, we expect biosimilar volume growth to be offset by declines in net selling price due to increased competition.

Murdo: Longer term, growth for biosimilars will come from expansion of existing products to new markets and launches of additional biosimilar molecules, such as Amgevita in the U.S. and biosimilars for Solaris, Stellara, and ILEA. In Oncology, Neulasta Onpro remains the preferred long-acting GCSF with 54% share of volume in the core. In Q1, we surpassed 1 million patients who, with the help of OnPro, were able to receive their GCSF treatment while reducing the need to return to their doctor's office or other site of care for administration.

Longer term growth for Biosimilars will come from expansion of existing products to new markets and launches of additional biosimilar molecules, such as <unk> and Davita in the U S and Biosimilars for Soliris still Lara NIH.

In oncology Neulasta on growth remains the preferred long acting G CSF with 54% share of volume in the quarter in Q1, we surpassed 1 million patients who with the help us on pro we're able to receive their G. CSF treatment, while reducing the need to return to their doctor's office or other site of.

Care for administration.

Murdo: Consistent with recent trends, Nelasta's U.S. average selling price declined 30% on a year-over-year basis, and we expect this trend to continue throughout 2021, driven by intensifying competition. Xgeva sales decreased 3% year-over-year for the first quarter as volume growth in Asia was offset by lower net selling prices in that region. U.S. unit volumes declined year-over-year driven by demand impacts in January and February, with recovery beginning in March and into April.

Consistent with recent trends and the last is U S average selling price declined 30% on a year over year basis, and we expect this trend to continue throughout 2021, driven by intensifying competition.

Ex Java sales decreased 3% year over year for the first quarter as volume growth in Asia was offset by lower net selling price in that region U S unit volumes declined year over year, driven by demand impacts in January and February with recovery beginning in March and into April.

Murdo: Kyprolis sales decreased 10% year over year for the first quarter as the pandemic suppressed the number of new patients starting treatment for multiple myeloma. Moving forward, we expect promotion to drive growth in the second line and beyond as a result of our launch of the combination indication of Kyprolis and Darzalex plus dexamethasone or DKD. The combination of Kyprolis with Sarcleza and dexamethasone, or ESA-KD, was also approved in court. As Bob mentioned, our team is ready to launch Sotiracib, or Lumacraz, upon approval, and we are excited to establish it as a foundational therapy for patients with advanced lung cancer. We've already launched our Biomarker Assist program, which removes access barriers to testing and helps appropriate patients without a pocket cost.

Kyprolis sales decreased 10% year over year for the first quarter as the pandemic has suppressed the number of new patients starting treatment for multiple myeloma moves.

Moving forward, we expect promotion to drive growth in second line and beyond as a result of our launch of the combination indication of Kyprolis and <unk>, plus dexamethasone or D. J D.

The combination of Kyprolis with <unk> and dexamethasone or <unk> KD was also approved in the quarter.

As Bob mentioned, our team is ready to launch <unk> acid or <unk> upon approval and we're excited to establish it as a foundational therapy for patients with advanced lung cancer, we've already launched our biomarker assist program, which removes access barriers to testing and helps appropriate patients without us.

Pocket costs.

Murdo: And 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 more than 2.5 million people in the world living with severe uncontrolled asthma. Overall, I'm pleased with our Q1 execution given the pandemic-related disruption of new patient diagnoses and treatment, and we'll continue our focused execution during Q2 and are projecting recovery over the second half of the year. With that, I'll turn it to Dave.

And 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 more than $2 5 million people in the world living with severe uncontrolled asthma.

Overall, I'm pleased with our Q1 execution, given the pandemic related disruption of new patient diagnoses and treatment and we will continue our focused execution during Q2 and are projecting recovery over the second half of the year with that I'll turn it to Dave.

Dave: Thanks, Murdo, and good afternoon, everyone. I'll begin with two new programs that are strong strategic fits within our portfolio. First, we are excited to welcome our new colleagues from Five Prime Therapeutics and begin work on Bumerituzumab. The integration is going well, and we have hit the ground running with Phase III planning activities. As Bob mentioned, we received breakthrough therapy designation from FDA and look forward to discussions with regulators on the development program, including Phase III, in the near future.

Thanks, Murdo and good afternoon, everyone I'll begin with two new programs that are strong strategic fits within our portfolio.

First we are excited to welcome our new colleagues from five Prime Therapeutics and begin work on <unk>. The integration is going well and we have hit the ground running with phase III planning activities as Bob mentioned, we received breakthrough therapy designation from FDA and look forward to discussions with regulators on the development program.

Including phase III in the near future.

Dave: We will also investigate pomerituzumab in other indications where FGFR2B may play a role, including squamous non-small cell lung cancer, and we'll have more to say on the entire development program as those plans are finalized. In inflammation, I would like to highlight our acquisition of Rodeo Therapeutics and their 15-prostaglandin dehydrogenase program, which was motivated by compelling preclin This is a nice illustration of our use of human genetic data to inform drug discovery and development.

We will also investigate <unk> in other indications, where <unk> may play a role, including squamous non small cell lung cancer and we'll have more to say on the entire development program as those plans are finalized.

In inflammation I would like to highlight our acquisition of <unk> therapeutics and their 15 prostaglandin dehydrogenase program, which was motivated by compelling preclinical data from rodeo and valuable insights from D. Code. This is a nice illustration of our use of human genetic data to inform drug discovery.

And development.

Dave: The LUMACRAST program continues to advance with several regulatory milestones in the first quarter, including global submissions for advanced non-small cell lung cancer and a priority review from FDA with a regulatory action date of August 16. We are having productive interactions with the FBA and multiple other regulatory agencies that will include Japan with today's anticipated submission, and we look forward to making LumaCrafts available to patients as soon as possible. We are also pleased to receive temporary authorization for youth status in France. This designation is to promote fast access to innovative medicines before marketing authorization and conventional access. And we have received a large number of requests.

The <unk> program continues to advance with several regulatory milestones in the first quarter, including global submissions for advanced non small cell lung cancer and the priority review from FDA with a regulatory action date of August 16.

We're having productive interactions with the FDA and multiple other regulatory agents agencies that will include Japan with today's anticipated submission and we look forward to making room across available to patients as soon as possible.

We're also pleased to receive temporary authorization for us status in France. This designation is to promote fast access to innovative medicines before marketing authorization and conventional access and we have received a large number of requests.

Dave: In the clinical development program, we completed enrollment in the phase 3 study versus dosotaxel in advanced non-small cell lung cancer. Based on the overall efficacy and safety profile of LumaCRAS and discussions with regulators, we reduced the sample size in this study while maintaining appropriate statistical power to assess the progression-free survival primary endpoint. The timelines of the study have not changed as the primary endpoint remains event-driven.

And the clinical development program, we completed enrollment in the phase III study versus Docetaxel in advanced non small cell lung cancer.

Based on the overall efficacy and safety profile of <unk>, Kras and discussions with regulators, we reduce the sample size in this study while maintaining appropriate statistical power to assess the progression free survival primary endpoint.

The timelines of the study have not changed as the primary endpoint remains event driven.

Dave: While we have demonstrated that the 960 mg dose is safe and efficacious in advanced non-small cell lung cancer, we continue to explore different doses and regimens, as is common in oncology drug development. As part of this effort, we are initiating a new cohort to determine whether a once-daily oral dose of 240 mg maintains the safety and efficacy profile of the 960 mg dose in patients with advanced non-small cell lung Should a lower dose be as safe and efficacious as 960 mg, it may further enhance the patient's experience with once-daily Lumicrat.

We have demonstrated that the 960 milligram dose is safe and efficacious in advanced non small cell lung cancer, we continue to explore different doses and regimens as is common in oncology drug development as part of this effort, we are initiating a new cohort to determine whether a once daily <unk>.

Oral dose of 240 milligrams maintains the safety and efficacy profile of the 960 milligram dose in patients with advanced non small cell lung cancer.

Should a lower dose is safe and efficacious as 960 milligrams. It may further enhance the patient experience with once daily <unk> Kras.

Dave: We expect the results from this study in late 2022 or early 2023 and do not expect any impact on the timelines of our ongoing priority review. We also continue to make good progress in evaluating combination regimens. Efficacy cohorts are underway for our MEK inhibitor, EGFR antibody, and oral EGFR inhibitor combinations, and we expect to present updates on these regimens at medical meetings in the second half of the year. We continue to evaluate doses and regimens to find the optimal options for patients in our other combinations, including PD-1 and SHIP-2. Finally, we are initiating triplet cohorts in colorectal cancer of the lumacrass with standard-of-care chemotherapy and either an anti-EGFR or anti-VEGF antibody.

We expect the results from this study in late 2022 or early 2023, and do not expect any impact on the timelines of our ongoing priority review.

We also continue to make good progress in evaluating combination regimens.

You can see cohorts are underway for our mechanism better Egfr antibody and oral Egfr inhibitor combinations and we expect to present updates on these regimens at medical meetings in the second half of the year.

We continue to evaluate doses and regimens to find the optimal options for patients in our other combinations, including PD, one and shipped to <unk>.

Finally, we are initiating triplet cohorts in colorectal cancer, <unk> kras with standard of care chemotherapy, and either an anti egfr or anti VEGF antibody.

Dave: In our BITE programs, we have initiated several new studies, including new indications for AMG-160, targeting PSMA in non-small cell lung cancer, and AMG-757, targeting DLL-3, now also being investigated in neuroendocrine prostate cancer. Details on these and other development programs, including small molecules, can be found in our press release. Turning to tezapelumab, developed in collaboration with AstraZeneca, the phase three navigator data were well received by clinicians, and additional analyses will be presented at the American Thoracic Society meeting in May.

In our bite programs, we've initiated several new studies, including new indications for AMG 160, <unk> targeting <unk> in non small cell lung cancer and AMG 757 targeting DLL three now also being investigated in neuroendocrine prostate cancer <unk>.

<unk> on these and other development programs, including small molecules can be found in our press release.

Turning to <unk> Mab developed in collaboration with Astrazeneca, our phase III navigator data were well received by clinicians and additional analyses will be presented at the American Thoracic Society meeting in May we remain on track to submit regulatory filings this quarter and believe the data support <unk>.

Dave: We remain on track to submit regulatory filings this quarter and believe the data support tezapelumab as a first-line biologic therapy for a broad population of patients with severe uncontrolled asthma. We are also investigating other indications with phase two studies in COPD and chronic spontaneous urticaria, and most recently, a phase three study for chronic rhinosinusitis with nasal polyps. Finally, on Otezla, we submitted a supplemental new drug application to FDA based on the Phase III Advanced Study in mild to moderate psoriasis. The positive results from ADVANCE were presented at the American Academy of Dermatology, or AAD, meeting a few days ago. In closing, I'd like to thank our staff for continuing to deliver medicine for patients.

<unk> as a first line biologic therapy for a broad population of patients with severe uncontrolled asthma.

We're also investigating other indications with phase II studies in COPD and chronic spontaneous urticaria and most recently a phase III study for chronic rhinosinusitis with nasal polyps.

Finally on a Tesla, we submitted a supplemental new drug application to FDA based on the phase III advanced study in mild to moderate psoriasis. The positive results from advance were presented at the American Academy of dermatology or AAD meeting.

Few days ago.

In closing I'd like to thank our staff for continuing to deliver for patients.

Erica: Okay, Erica, thank you. Let's turn now to Q&A, and perhaps you could remind our callers of the procedure for asking questions. Thanks.

Okay. Erica. Thank you, let's turn now to Q&A and perhaps you could reminder.

And our callers of the procedure for asking questions. Thanks.

As a reminder to ask a question you will need to press star one on your telephone you withdraw your question press the pound key please standby, while we compile the Q&A roster.

unknown: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Your first question is from Geoff Meacham with Bank of America.

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

Hey, guys. Thanks for the question.

I had a question on our Tesla the head to head against the crab is sitting up.

At AAD showed some pretty meaningful differentiation I just wanted to ask from a maybe a commercial perspective, how does that data set along with the advanced state of change you're thinking about the positioning of hotels on the marketplace with respect to psoriasis. Thank you.

Murdo: Murdo? Yeah, thanks, Geoff, for the question. The first thing I would just reiterate is that we anticipated that the DUCRA data would indeed show what they did show, and we assumed that in the model that we put together for the transaction, and we've assumed that for the balance of this year. What I would say is that we continue to believe that OTESLA is really ideally positioned in the first-line prebiologic psori

Murdo, yes.

Yes, Thanks, Jeff for the question.

The first thing I would just reiterate is that we anticipated.

The <unk> data would indeed show what they did show and we assume that in the model that we put together for the transaction and we've assumed that for the balance of this year.

What I would say is that we continue to believe that it will Tesla is really ideally positioned in the.

First line pre biologic psoriasis market as I mentioned in my prepared remarks, we've been on the market for six years now we have in market cumulative patient experiences over 500000 individuals globally.

Murdo: As I mentioned in my prepared remarks, we've been on the market for six years now. We have in-market cumulative patient experience with over 500,000 individuals globally. We have excellent commercial and payer coverage at over 90% of covered lives, and we continue to make really good progress, holding a 30% share in the market with really outstanding customer facing capabilities. The other thing that we, of course, look at is positioning in the market and how that holds up against not just Duker but other competitors, and we think that, you know, we really are the first kind of option pre-biologic post-topical, and dermatologists have become very comfortable using Otezla that way.

We have excellent.

Commercial and.

Payer coverage at over 90% of covered lives.

And we continue to make really good progress holding a 30% share in the market with really outstanding.

Customer facing capabilities. The other thing that we of course look at us positioning in the market and how does that holds up against not just duker, but other competitors and we think that we really are the first kind of option pre biologic post topical.

And dermatologists have become very comfortable using <unk> that way payer coverage is consistent with that position in the market.

Murdo: Payer coverage is consistent with that position in the market, and with the pending mild to moderate indication data which were presented at the same AAD meeting, which looked quite compelling, we expect to be able to expand our utilization of Otezla and the psoriasis population in the milder patient type. So overall, we like our position in the market; you know, the way I see it is we still have to see how the full detailed safety data look for the TIK2 product given that it is part of the JAK family, and you know, it took six years and over 200,000 patients for us to understand the Zeljan safety profile, so I think there's a lot still to be understood here, but not necessarily the safety and efficacy of O Okay.

And.

With the mile to pending mild to moderate indication.

Data, which were presented at the same AAD meeting, which will be quite compelling.

We expect to be able to expand our utilization of us.

<unk> psoriasis population and the milder patient type so.

Overall, we like our position in the market.

The way I see it as are we.

We still have to.

See how the full detailed safety data look.

For the TIK two product given that it is part of the Jack family and.

It took six years and over 200000 patients for us to understand the Xeljanz safety profile. So I think there's a lot still to be understood here, but but not necessarily the safety and efficacy of Oh Tesla.

Okay, great. Thank you.

David: Your next question is from Michael Yee with Jeffreys.

Your next question is from Michael <unk> with Jefferies.

unknown: I had a question, maybe for David. You had a nice update and comments on KRAS. Maybe you could just put some context around the timing of data now for the second half around MECC. Maybe talk about what drives the timing of that and disclosure. And then the comment around 240 versus 960.

I had a question maybe for David.

You had a nice update and comments, Sean K rash.

Maybe you could just put some context around the timing of data now for the second half.

Around Mac, maybe talk about what drives the timing of that and disclosure and then the comment around $2 40 versus 960, I think there'll be different ways to interpret that and maybe you can make a comment about that because I thought 960 was pretty well tolerated profile sure Richard.

unknown: I think there'd be different ways.

unknown: Srinivas Jyothibodhanamayi, Aniruddha Mukherjee, Aniruddha Mukherjee,

unknown: Profile. So, Ben Rich and Colin.

Rents on that that'd be great. Thanks, David.

David: Yeah, thanks, Mike. Both great questions.

Thanks, Mike both great questions I think.

David: You know, I think, you know, our anticipation is that at meetings right after the second half, you know, right into the start of the second half of the year, we'll start to see some of the cohort data that we outlined, you know, MEK, and then both EGFR antibody and small molecule inhibitor combinations. And, you know, you can probably see those come out sequentially over the second half of the year as we accumulate data.

Our anticipation is that at meetings right after the second half.

Right into the start of the second half of the year, we'll start to see.

Some of the cohort data that we outlined Mac.

Then both Egfr antibody small molecule inhibitor combinations.

You can probably see those come out sequentially over the second half of the year as we accumulate data I would say that the combination therapy programs are moving along quite rapidly.

David: I would say that the combination therapy programs are moving along quite rapidly, and as we mentioned, we've opened some new triplet combinations. So I feel very good about where we are in the status of combination regimens. In terms of the dose comparison study, we now have long-term data from both our phase one trial as well as the phase two trial, updated target coverage information, pharmacokinetics, as well as, of course, efficacy and safety data.

As we mentioned we've opened some new triplet combination so I feel very good.

Where we are in the status of combination regimens are in terms of the dose comparison study.

We've now got long term data from both our phase one trial.

As well as the phase II trial.

Updated target coverage information pharmacokinetics.

As well as of course efficacy and safety data and based on modeling.

David: Based on modeling, we wondered if we could achieve adequate target coverage at 250 and preserve potentially the same efficacy profile that we've seen at 960 milligrams. You know, and so, you know, that's just a question that we're going to ask.

We wandered off could we achieve adequate target coverage at $2 50, and preserve potentially all of the same efficacy profile.

Okay.

We've seen at 960 milligrams.

And so that's just a question that we're going to ask us quite common to continue.

David: It's quite common to continue dose exploration in oncology molecules, and I would view this as par for the course. We are very pleased with the tolerability profile. And as you pointed out, at 960 milligrams, we had, you know, an outstanding experience. In fact, this is one of the best tolerated drugs that I've been involved with, you know, in 30 years of oncology drug development. And that's not really, you know, what a driver this is. But, you know, can we potentially get by with efficacy at a lower 240 milligram dose and, you know, enhance the patient experience?

<unk>.

Exploration in oncology molecules.

I'll review this is par for the course, we are very pleased with the Tolerability profile and as you pointed out at 960 milligrams.

We've had an outstanding experience in fact this is one of the best tolerated drugs.

I've been involved with <unk>.

30 years in oncology drug development.

And that's not really what.

The driver is here, but can we potentially get by with efficacy at a lower 240 milligram dose.

And.

Enhanced patient experience.

David: Your next question is from Jay Olson with Oppenheimer.

Yes. Thank you.

Your next question is from Jay Olson with Oppenheimer.

Jay Olson: Oh, hey, thanks for taking the question. I'm curious about the phase two data for Opasaran that you expect in the first half of next year. Can you just talk about what sort of signals you'll be looking for in that data in terms of your plans to design a phase three study and any potential points of differentiation from Pelican?

Oh, Hey, thanks for taking the question.

Curious about the phase III data for all paths around that you expect in the first half of next year can you just talk about what sort of signals youll be looking for in that data in terms of your plans to design a phase III study and any potential points of differentiation from pellet Carson.

unknown: Pellicarson. Thank you. Yeah, thanks.

Thank you.

Yes, Thanks, Jay and for those who may not know off the top of our heads what the old passerine US. This was formerly AMG 890, it's small interfering RNA.

David: Yeah. Thanks, Jay. And for those who may not know off the top of their heads what Opasaran is, this was formerly AMG-890. It's a small interfering RNA designed to lower lipoprotein A levels in patients with atherosclerotic cardiovascular disease where elevated LP-a may be a driver. As we noted, we completed enrollment in what's a robust phase two trial that actually completed enrollment ahead of schedule. And what we'll be looking for as we unveil those data, Jay, are, first of all, you know, longer term.

Combined to lower LIFO protein levels.

Paul levels in patients.

With asos chronic cardiovascular disease, where April elevated LP little a may be a driver.

As we noted we completed enrollment in a robust phase II trial that actually completed enrollment ahead of schedule.

We'll be looking for.

As we unveil those data.

Jay are first of all longer term.

David: Follow-up, meaning sufficient long-term suppression of LP little a levels, and you know our targets would be in the range of the phase one data that we presented last November at the American Heart Association meeting and then, of course, additional safety data, and of course, we are exploring different dose levels, as is pretty much standard in a program like this, and so this would be in part for dose selection for phase three going forward. We are very actively engaged already in phase three planning and what the design of that sort of trial may look like based on the data that we've seen to date. One of our goals may be relatively infrequent dosing given the duration of effect that we observed in the phase one trial, and that's one thing that we'll be taking a close look at as well in phase two. Great, thank you.

Follow up meaning sufficient long term suppression of LP little a levels.

Our targets would be in the range of the phase one data that we presented last November at the American Heart Association meeting and then of course saw additional.

Safety data and of course, we are exploring different dose levels as us.

Pretty much standard.

In a program like this and so this would be in part for dose selection for phase III going forward. We are very actively engaged already in phase III planning and what the design of that sort of trial may look like based on the data that we've seen to date.

One of our goals may be relatively infrequent dosing given the duration of effect that we have.

<unk> in the phase one trial and Thats, one thing that we'll be taking a close look at us well in phase II.

Alright, great. Thank you.

Matthew Harrison: Your next question is from Matthew Harrison with Morgan Stanley. Great. Good afternoon. Thanks for taking the question.

Your next question is from Matthew Harrison with Morgan Stanley.

Great. Good afternoon. Thanks, Richard.

I was wondering if you could just.

unknown: Comment in a little more detail on the Raffat trend. It looks like we're really starting to see the product break out a little bit here and not seeing some of those first quarter gross to net issues that you've sort of experienced in the past couple years. Do you think you're at a point now where you're going to get substantial Part D penetration and also see rest of world penetration? Maybe you could just comment on your outlook there.

I'm, a little more detail on the breakdown.

It looks like we're really starting to see the product breakout a little bit here and not seeing some of those first quarter gross to net issues that you've sort of experienced.

A couple of years.

Do you think youre at a point now where youre going to get the substantial part D penetration and also see rest of world penetration, maybe you could just comment on your outlook there.

Murdo: Yeah, thank you, Matthew. We are pleased, obviously, with the quarter for Repatha. And, you know, it's been a bit of a journey getting here and trying to ensure that patients have affordable access to Repatha, particularly in Medicare Part D, as you point out. I would say that, with one exception, we are anticipating a relatively stable net price for the remainder of the year. And the exception that I'm pointing out is that as we grow up quite a bit, so we do have more exposure to the doughnut hole over time.

Yes. Thank you Matthew we are pleased obviously with the quarter for a pass on.

<unk>.

A bit of a journey getting here and trying to ensure that patients have affordable access to a path of particularly in Medicare part D. As you point out.

I would say that we are anticipating with one exception we are anticipating relatively stable net price for the remainder of the year and the exception then.

Pointing out is that as we expand our penetration of Medicare part D. We will have.

Some drag on our net price as a function of patients entering and staying in the donut hole for a period of time so.

Murdo: But as you can see from the first quarter, we were more than able to offset that small drag on net price. And we anticipate that we'll continue to penetrate that patient population, given the very strong payer coverage we have there with, you know, between commercial and Medicare, we've got over 80% covered lives for this important product. And there are still millions of patients out there who are suboptimally treated for their hyperlipidemia, given that they're at very high risk of cardiovascular events.

That's the one downside of helping patients in Medicare part D. There is still a coverage gap in that benefit.

And of course.

The given the durability of treatment in the chronic nature of <unk>. They can be in coverage gap for quite a bit. So we do have more exposure to the donut hole over time, but as you could tell from the first quarter, we were more than able to offset that that small drag on net.

Net price and we anticipate that will continue to penetrate that patient population given the very strong payer coverage, we have there with between commercial and Medicare We've got over 80% covered lives for this important product and there are still millions of patients out there who are sub optimally treated for their hyperlipidemia.

Given that they are at very high risk of cardiovascular events, so and globally, we're seeing some really strong performance in Europe and the Americas.

Murdo: So globally, we're seeing some really strong performance in Europe and the Americas. China is doing quite well, despite not having an NRDL listing. And we continue to make inroads in Japan, where we are the only PCSK9 on the market.

China.

<unk> is doing quite well.

<unk> not having <unk> listing and we continue to make inroads in Japan, where we are.

We are the only <unk> on the market.

Yaron Werber: Your next question is from Yaron Werber with Talon & Company.

Your next question is from our yarn Warburg with Cowen <unk> company.

David: Great. David, if you don't mind, I just have a follow-up question as well about LumaCrest relating to the PD-1 combo specifically. I think you've said in the past that you haven't gotten to the MTD on both drugs as you tested them in combination, and it sounds like you're continuing to explore dose and schedule. You've also recently talked about sequential therapy, so we're just trying to say, are we actually going to get data in the second half, and why are you testing sequential therapy? What are you trying to say? Thank you.

Great. David If you don't mind I just have a follow up question as well about <unk> related to PD. One combo, specifically I think you've said in the past that you haven't gotten to the MTT on both.

Both drugs as you test it in combination it sounds like you're continuing to explore dose and schedule. You've also recently talked about sequential therapy. So we're just trying to say are we actually going to get David on the second half and why are you testing sequential therapy or what are you trying to say thank you.

David: Yeah, thanks, your own, we're continuing to look at a variety of approaches in combination with PD ones, whether that's in combination or sequentially. I think it's fair to say that a number of small molecules, EGFR inhibitors, BRAF inhibitors, MEK inhibitors, have challenges combining with PD-1s, and I think there's a fair amount of work out here. We are, you know, we I don't know if we'll have data that's robust enough to share in the second half of the year. That's possible, but I don't want to promise that, but certainly we'll provide guidance as those different regimens move along, and sequential therapy may actually be a preferred approach here.

Yes, Thanks Sharon.

We're continuing to look at a variety of.

Approaches in combination with PD ones, whether that's in combination or sequentially.

I think it's fair to us.

<unk>.

A number of small molecules Egfr inhibitors, BRAF inhibitors, mec inhibitors have challenges combining with <unk>.

PD ones.

And I think there's a fair amount of work out here we are.

We will provide updates I don't know if we'll have data that's robust enough to share in the second half of the year, that's possible, but I don't want to promise that but certainly we will provide guidance on as those <unk>.

<unk> regimens move along and sequential therapy.

Actually a preferred approach here.

Unknown Executive: Your next question is from Terrence Flynn with Goldman Sachs.

Your next question is from Terence Flynn with Goldman Sachs.

David: Hi, thanks for taking the question. Maybe just one follow-up on that. Dave was just wondering, does the 940 mg dose exploration have to do with this question on how to best combine KRAS with a PD-1? And then my other question, I just wanted to ask Bob or Peter, if you could comment on the tax proposals coming out of D.C. and any implications for your Puerto Rico, some of the tax benefits you get out of Puerto Rico on the manufacturing side. Thank you.

Hi, Thanks for taking the question, maybe just just one follow up on that day.

Dave I was just wondering does the 940 Meg dose exploration have to do with this question on.

To best combine <unk> with a PD one and then my other question I just was wondering Bob or Peter if you could comment on the tax proposals coming out of D C and any implications for your Puerto Rico.

Some of the tax benefits you get out of Puerto Rico on the manufacturing side. Thank you.

David: Thanks, Terence. I'll take the first part of that question. Yeah, the 240 milligram dose comparison study doesn't really have anything to do with the combination dosing. As you're aware, in combination regimens and oncology, one typically explores a range of doses that, you know, potentially include all of the members of that combination regimen, depending on what the backbone may be. But this is really a monotherapy exploration, and again, to see whether we can preserve efficacy at a lower dose, at this lower 240 milligram dose.

Yeah. Thanks, Terence I'll take the first part of that question.

Yes, the 240 milligram dose comparison study.

It doesn't have really anything to do with the combinations.

Dosing as Youre aware.

In combination regimens in oncology, one typically explores a range of doses.

Potentially.

All of the members of that combination regimen, depending on what the backbone may be but this is really a mono therapy exploration.

And again determined to see whether we can preserve efficacy at a lower dose at this lower 240 milligram dose.

Peter H. Griffith: On the tax front, Peter, why don't you share our thoughts? I would. Terrence, very good question there. And look, I think it's premature to speculate on this. We expect the administration.

On the tax front, Peter once you share thoughts.

Terence the very good question there.

And look I think it's premature to speculate on.

We expect the administration's proposal to be subs.

Peter H. Griffith: We expect the administration's proposal to be subject, I think, as everybody does, to significant debate within Congress.

Subject I think as everybody does too significant debate within Congress and other stakeholders.

Rest assured we are active in Washington to ensure that our position that our taxes should continue to be competitive.

unknown: Washington to ensure that our position, that our tax system should continue to be competitive.

Continue to really encourage innovation in the United States as well heard and understood.

<unk>.

We are very supportive and you can imagine of incentives to encourage manufacturing in the United States in the U S territory in Puerto Rico, and as Terrence I would just let you know that our tax liter Jackie growth as.

unknown: And we are very supportive, as you can imagine, of incentives to encourage manufacturing in the United States and U.S. territories.

As much expertise in the area of Puerto Rico, not just around taxes, but just overall.

unknown: I just want to let you know that our tax leader, Jackie Kraus, has much expertise in the area of Puerto Rico, not just around taxes but just overall on how the economy is developing.

Into how the economy down there functions and so forth species, followed upon regularly by the legislature.

Or advice and counsel.

Again for the questions.

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

Hi, Thanks, so much for taking my question, David I have a two part question on care asked.

unknown: She's called upon regularly by legislatures for advice and counsel. Thanks again for the question.

First perhaps if you could just walk us through your thought process on why 240 in particular, why not 180 or 360, and I say that in the context of having seen responses as low as 180, <unk>, perhaps you could even give us a flavor for the PK curves look like around the 240 doses above and below.

Umer Raffat: Your next question is from Umer Raffat with Evercore ISI.

David: Thanks so much for taking my question. David, I have a two-part question on KRAS.

unknown: First, perhaps, if you could just walk us through your thought process on why 240 in particular? Why not 180 or 360? And I say that in

Secondly, I recall back when the phase III was initiated per K Ras the powering math was really directed at OFC not PFS, even though the primary endpoints of PFS.

unknown: [inaudible] I learned the evolution and thought process away from OS and what we can reasonably expect on p-values around OS with data as it emerges. Thanks, Umer. Good questions.

I realize the conversations with FDA have moved towards PFS and it looks like the new powering is more than reasonable for PFS, but I do want to understand the evolution and thought process away from O S and what we can reasonably expect on P values around OS with data as it emerges. Thank you.

David: Yeah, the 240 milligram dose was chosen, you know, based on modeling that we've done that really takes account of all of the dose levels, pharmacokinetic data, target coverage data, or accumulated preclinical data regarding efficacy at different target coverage levels. And, you know, this was really chosen as a lower bound where we thought we would potentially preserve or could preserve the efficacy that we're seeing at 960 milli You know, in regards to the phase 3 trial, you know, as you note, we changed the powering to really have good power on the progression-free survival endpoint.

Thanks.

Good questions.

240 milligram dose was chosen based on modeling that we've done.

That really takes account of all of the dose levels pharmacokinetic data target coverage data our accumulated preclinical data regarding efficacy at different target coverage levels.

And this was really chosen as a lower bound where we thought we would potentially preserve or could preserve the efficacy that we're seeing at 960 milligrams.

In regards to the phase III trial as you note.

We changed the powering to really.

We have good power on the progression free survival endpoint that was done in concert with regulators.

David: That was done, you know, in concert with regulators. We will be able to take a look at overall survival. You know, the power will be somewhat reduced in terms of the overall survival endpoint, but, you know, I think we'll still have a pretty good sense of what the drug is producing in terms of overall survival. Part of the thinking here as well is to minimize exposure of patients to the docetaxel control arm. Thank you. Your next question is from Mohit Bansal with Citi.

We will be able to take a look at overall survival.

The power will be somewhat reduced.

In terms of the overall survival.

Endpoint, but I think we'll still have.

Pretty good sense of what the drug is producing in terms of overall survival all part of the thinking here as well as to minimize exposure.

All patients to the Docetaxel control arm.

Thank you.

Your next question is from Mohit Bansal with Citi.

Question and maybe one question for Murdo.

<unk>.

<unk> has done really well.

Due to pandemic.

Mohit Bansal: Question and

unknown: [inaudible] Mohit, the contracts aren't necessarily on a schedule. We have some large networks where we negotiate annually, but we have a lot of smaller, what we call value-based accounts where we contract on a much more non-calendarized basis. So they're happening throughout the course of the year. And with respect to your question about reversal, are you asking me about price trends, or volume trends? Can you clarify that question? I mean, the trends. I mean, because there was a trend towards using more on-pro versus the PFS, given it is an at-home product. So do you think there could be some kind of reversal there as the pandemic subsides?

Could you please remind us how often these contracts that are negotiated and should we expect any reversal in entre trends you see.

Anything there as dependent except site. Thank you.

Thanks Mohit.

The contracts aren't necessarily on a schedule we have some large networks, where we we negotiate annually, but we have a lot of smaller what we call value based accounts, where we contract on a much more.

Sean calendar is basis, so they're happening throughout the course of the year.

And as your question with respect to reversal.

Asking me about price trends volume trends can you clarify that question.

Because there was a trend towards using more on accrual versus the PFS given it is to take him at home products. So do you think there could be some kind of reversal there as the pandemic subsides.

Then patients can come in and then get their shops.

unknown: [inaudible]

Murdo: Yeah, thank you for the clarification. Obviously, we're watching that. Clearly, the pandemic was stimulus for many oncologists to think more carefully about the GCSF treatment that they were going to use in order to help minimize the amount of provider interaction that patients would incur. What we have been doing in the meantime, though, is reinforcing that you actually can improve outcomes by using Long Acting GCSF and using OnPro in particular, so we have a promotional effort that I think is helping strengthen the volume demand curve.

For the clarification, obviously, we're watching that clearly the pandemic was stimulus for many oncologists to think more carefully about the G. CSF.

Treatment that they were going to us in order to help minimize the amount of provider interaction that patients would incur what we have been doing in the meantime, though is reinforcing that you actually can improve outcomes by using a long acting G CSF and using on pro in particular, so we have a promotional effort that.

I think is helping strengthen the volume demand curve. The only thing I will continue to point out though is with competition come some price erosion and we have a new competitor entrant in that category in the long acting G. CSF category. So we anticipate.

Murdo: The only thing I will continue to point out though is that with competition comes some price erosion, and we have a new competitor entrant in that category in the Long Acting GCSF category. So we anticipate more net price negative evolution through the remainder of the year.

More net price.

Evolution negative evolution through the remainder of the year.

Geoffrey Christopher Meacham: Your next question is from Geoffrey Porges with SVB Larynx.

Got it thank you very much.

Your next question is from Geoffrey Porges with SBB Leerink.

Murdo: Thank you very much for the question. Murdo, could you just discuss the issue of price, the pretty significant negative price effect. First of all, could you tell us whether that's all in the U.S. or whether it's U.S. and ex-U.S.

Alright, Thank you very much for the question.

Could you just discuss the issue of price.

Pretty significant negative price effect first of all could you tell us whether that's all in the us whether it's U S and ex U S. And then secondly, since you're in the US took significant price increases at the end of the year.

Murdo: And then secondly, since you in the U.S. took significant price increases at the end of the year but still have a negative price queue on queue, it looks like eight or nine percent. Is this going to be a trend that persists throughout the year? And then, Bob, perhaps you could comment on what we should be modeling in terms of legislative or executive order changes to pricing going forward. You usually have your finger on the pulse in Washington. All right. Thanks, Geoff.

But still have negative price Q on Q.

Looks like eight or 9%.

Is this going to be a trend that persists throughout the year and then perhaps you could comment on what we should be modeling in terms of legislative or executive order changes to pricing going forward.

Usually you have your finger on the pulse in Washington.

Sure Alright. Thanks, Thanks, Jeff Let me go first on the overall price evolution in the portfolio. We continue to believe that mid single digit net negative price for the portfolio for the year is the right number that's what we continue to see what what you know and what we experienced probably more than some.

Bob Bradway: Let me go first on the overall price evolution in the portfolio. We continue to believe that a mid-single-digit net negative price for the portfolio for the year is the right number. That's what we continue to see. What you know and what we experience, probably more than some of our peer companies in the first quarter, given the nature of our portfolio, is more net negative price evolution because of patients renewing their benefits and going through benefit re-verification and hitting their kind of out-of-pocket resets.

Of our peer companies and in the first quarter given the nature of our portfolio is more net negative price evolution because of patients renewing in their benefits and going through benefit re verification and hitting their kind of out of pocket resets and so our co pay assistance programs have more drag.

Bob Bradway: And so our co-pay assistance programs have more drag. We did activate more payer access at the end of last year to address this. So we did have, on some brands, some increased payer coverage at the cost of some net price negative evolution. But we do anticipate Q1 being the lowest comparator, Q2 a little better, and then Q3 and Q4 being better thereafter. Great, thank you. And Geoff, on Washington, I'm not sure whether executive order is the concern these days or whether it's something that's attached to reconciliation. If I had to guess, I'd say there's a greater risk of something being attached to reconciliation. But it's still not very clear how this administration and members of the Democratic Party will work together.

We did activate more payer access at the end of last year into this so we did have on some brands some increased payer coverage at the cost of some net price negative evolution, but we do anticipate.

Q1, being the lowest compare Q2, a little better and then Q3 and Q4 being better thereafter.

Great. Thank you and Jeff on Washington, I am not sure whether executive orders.

The concern these days or whether its something thats attached to reconciliation if I had to guess I'd say the greater risk is something being attached to reconciliation, but it is still not very clear how this administration and members of the Democratic Party and general wanted to try to tackle the question of drug pricing.

This year. So we're continuing to stay very involved as you would expect.

We've benefited I think us being able to demonstrate.

Just how important innovation is with us.

Roger Susi being made against the.

The pandemic.

And so we'll continue to stay active and focus on the things that can be done to improve patient access to medicines.

I think the other thing Jeff is to continue to shine a light on the.

unknown: [inaudible] Right, thank you. Your next question is from Alethea Young with Canter Fitch. Hey guys, thanks for taking my question. I just wanted you guys to

On the role of the middlemen and how much of the pharmaceutical.

No wind up in the hands of the middlemen, which is which I think now.

Cross the country is just in excess of 50% I think it actually is at 51% now so we'll continue to draw attention to that as well.

Alright, thank you.

Your next question is from Alethia young with Cantor Fitzgerald.

Hey, guys. Thanks for taking my question I. Just wanted you guys to talk a little bit more about the moderate to severe psoriasis market and how you plan on kind of penetrating what they call a commercial sales force you have especially in light of potential competition that may emerge overtime with Bristol and then just also with US up two program is that still underway of the combo.

Unknown Attendee: Your next question is from Alethea Young with Cantor Fitzgerald. Hey guys, thanks for joining me.

Nations and you guys. Thanks.

Unknown Attendee: Maybe I'll just start very quickly, Alethea, SHIP2, yeah, that's underway. And, you know, we're continuing to work on that combination, Mordico, Murdo. Yeah, and Alethea, as I mentioned earlier in response to the question on the TIC-2 data that were recently presented, we, as I've mentioned in the past, have begun primary care promotion for Otesla in the currently labeled mild to moderate patient population and have seen a good response there in terms of uptake, with an 11 percent TRX year on year performance for the quarter. We're pretty pleased with that evolution.

Maybe I'll just start very quickly.

<unk> shipped two yes, that's underway.

We're continuing to work on that combination of more to come and.

Murdo, yes I.

I know they see us as I mentioned earlier in response to the question.

On the.

<unk>.

Two data that were recently presented.

We as I've mentioned in the past we have begun primary care promotion.

Four Oh Tesla in the currently labeled mild to moderate patient population.

<unk> has seen good response, there in terms of uptake with 11% <unk> ex year on year performance.

<unk> for the quarter.

We're pretty pleased with that evolution, what we are seeing us a slowdown in the psoriasis patient population in the newly diagnosed patient population in particular.

Murdo: What we are seeing is a slowdown in the psoriasis patient population, in the newly diagnosed patient population, in particular. And we think this is a direct impact of COVID causing patients with psoriasis not to see their dermatologist starting, you know, really at the beginning of the pandemic. But what's happened is that the cumulative effect of this is starting now to impact the patients that have passed through some of the topical options. And, you know, we depend on bio naive patients for our growth. So we are definitely a pre biologic option for dermatologists. So we are watching that closely.

We think this has a direct impact of COVID-19, causing patients with psoriasis us not to see their dermatologist.

<unk> really at the beginning of the pandemic, but what's happened is the cumulative effect of this is starting to impact the.

The patients that have passed through some of the topical options and <unk>.

We depend on bio naive patients for our growth. So we are definitely a pre biologic option for dermatologists. So so we are watching that closely and we think that that could continue to create some softness in the pre biologic psoriasis patient market opportunity into Q.

Murdo: And we think that that could continue to create some softness in the pre-biologic psoriasis patient market opportunity into Q2, with recovery thereafter, because we are seeing much more patient volume in dermatology offices in March and into April. So we think that things are recovering, but it'll take a while for that cumulative effect of new patient softness to work its way through the market. In terms of overall positioning in the market, we continue to think that our safety and efficacy profile is a very attractive option for patients and dermatologists as that first systemic agent pre-biologic.

Two with recovery thereafter, because we are seeing much more.

Patient volume in dermatology offices in March and into April. So we think that things are recovering, but it will take a while for that cumulative effect of new patient softness to work its way through the market.

In terms of overall positioning in the market. We continue to think that our safety and efficacy profile as a very attractive option for patients and dermatologists as that first systemic agent pre biologic.

Murdo: And I think really, you know, these days in rheumatology and dermatology, physicians are much more aware of the different categories of options that they have and the different profiles of the different classes of drug. And I think that with recent data in the Jack category, there'll be some speculation and some hesitancy to use a product like the tick as a first biological option to treat patients.

And I think really these days in rheumatology and dermatology physicians are much more aware of the different categories of options that they have in the different profiles of the different classes of drugs and I think that with recent data in the JAK category there'll be some.

Some speculation in some hesitancy to us a product like that take to as a first bio naive option to treat patients.

Hey, Eric Thanks, Let's go to the next question.

Dane Vincent Leone: Your next question is from Dane Leone with Raymond James.

Your next question is from Dane Leon with Raymond James.

unknown: Hi, thank you for taking the questions and congrats on the update and the start to the year. So the question for me, which is a follow up to some of the Tara Sibb questions, is really, maybe since people have been asking about fairly specific things, I think what everyone's trying to analyze in some of the updates, if we're really only getting longer term follow up on your pivotal data set at ASCO, is, you know, what's the team's view right now of the ability to move Satoru Cib into the frontline setting and long?

Alright, Thank you for taking the questions and congrats on the update on the start to the year.

So the question for me just as a follow up to some of those terrorists or questions is.

Really maybe since people have been asking about fairly specific things.

I think.

What everyone's trying to analyze and in some of the updates if we're really only getting.

Longer term follow up on your.

Pivotal data set at <unk>.

What's the team's view right now of the ability to move tourists into the frontline setting in lung.

unknown: A lot of us had thought that you would need a combination, a successful combination with PD1, to move into the frontline setting. Obviously, we haven't seen you guys start a pivotal data set, and you just said, you know, it might take longer to figure out that algorithm. Alternatively, you go down the SHIP-2 pathway. Do you, one, have a timeline for showing us SHIP-2 combination data?

A lot of US had thought that you would need a combination successful combination with PD one to move into frontline setting. Obviously, we havent seen you guys start a pivotal data set and you just said it might take longer to figure out that algorithm.

Alternatively, you go down the ship two pathway do you one have a timeline for showing us ship two combination data.

And to us.

Is there an alternative paths for getting us the tourists that are into the frontline lung setting that we should be thinking about that we might be missing on this call right now.

David: [inaudible]

David: Yeah, thanks, Dane. You know, in terms of potential frontline combinations, I think a number of them that are being examined in the master protocol, if we can enhance efficacy by multiple hits on the pathway, could be feasible. For example, the MEK combination, you know, the EGFR inhibitor combination, And then, as well, as you mentioned, PD-1, whether that is in combination or sequentially, for example, to rely on a priming effect is a question that we're trying to answer.

Thank you.

Thanks Dean.

In terms of potential frontline combinations I think a number of them that are being examined in the master protocol.

If we can enhance efficacy by multiple hits on the pathway could be feasible for example, the net combination.

The Egfr inhibitor combinations.

And then as well as you've mentioned.

PD, one whether that is in combination or sequentially.

For example to rely on a priming effect is a question that we're trying to answer our ship too I would also consider an.

David: SHIP-2, I would also consider an additional hit on the pathway and would also fall into that grouping. So I think, you know, we'll be guided by emerging data, but all of those would be potential avenues into earlier lines of therapy. In addition, they could also potentially be avenues into other indications, such as colorectal cancer and some of the other solid tumors where G12C mutations occur.

An additional hit on the pathway and would also fall into that grouping so.

I think we'll be guided by emerging data, but all of those.

Would be potential avenues into earlier lines of therapy in.

In addition, also potentially avenues into other indications such as colorectal cancer and some of the other solid tumors, where <unk> mutations occur.

Unknown Attendee: Your next question is from Ronnie Gale with Bernstein.

Your next question is from Ronny Gal with Bernstein.

David: Good afternoon, and thank you for fitting me in. To you, first, just the traditional sort of asking questions.

Good afternoon, and thank you for fitting me in two if I may 1st just the traditional sort of asking the question.

David: I guess we saw some data in ACR about patients having multiple escape mutations from the first, from being when treated with a KRS-U12C inhibitor. And I was wondering, does that concern you that the patient escapes so quickly with multiple mechanisms? Does that suggest that maybe two agents will not be enough, or is that kind of par for the course? And, you know, this is what was expected. And second, we have seen some of your peers license Chinese-developed and tested products to bring to the developed market, especially in oncology.

I guess, we saw some data at ACR by patient, having multiple escape mutations from the first from being treated with a K rescue <unk> inhibitor and <unk>.

Was wondering if does that concern you that patient escapes so quickly with multiple mechanism.

That suggests that maybe two agents will not be enough for us that cannot parts with of course and this is what was expected and second we have seen some of your peers license, China developed and tested product to bring to the developed market.

Especially in oncology and I was wondering if you consider the strategy, especially as the Biosimilar player. It just seems to be a natural complementary strategy and if so where did you come out of that.

David: And I was wondering if you'd consider this strategy, especially as a similar.

unknown: And maybe I'll start with the first part and then have Murdo address the second part. Yeah, in terms of the mutational patterns that were recently reported, I would say that biologically, nothing that we saw surprised us based on everything we've learned about these pathways in the last 30 to 40 years and the potential mechanisms of resistance. This also points the way, I think, to specific combinations that may, in fact, help to ameliorate those resistance patterns.

Maybe I'll start with the first part and then.

Have murdo address the second part yes.

Yes in terms of the mutational patterns that were recently reported.

I would say that biologically nothing that we saw surprised us based on everything we've learned about these pathways in the last 30 to 40 years and the potential mechanisms of resistance. This also points the way I think too specific.

Combinations that may in fact help to ameliorate those resistance patterns I will point out that we will be presenting.

unknown: I will point out that we will also be presenting, in short order, updated comprehensive biomarker data, including mutational data, and I think you'll find that of interest. And that is certainly helping to guide our own thinking about the development program as well. Umer, do you want to take the second half of the question? Yes, Ronnie.

In short order here also.

David comprehensive biomarker data, including mutational data and I think you'll find that of <unk>.

Interest and that is certainly helping to guide our own thinking about the development program as well Murdo you want to take the second half of the question, Yes, Ronny we.

Murdo: We continue to look globally for product opportunities to license and promote around the world. And I think in oncology, in particular, there have been some interesting deals done lately. We obviously have a strong partnership already with a company based in China through Beijing, and we continue to enjoy that partnership and the co-development that we have. I would also say that given our global footprint, Amgen really is an excellent partner choice with our global capabilities in oncology and general medicine. So we're open to doing business with Chinese companies, Japanese companies, global companies. Absolutely.

We continue to look globally for product opportunities to license and promote.

In the World and I think in oncology in particular, there have been some interesting deals done lately.

We obviously have a strong partnership already with a company based in China through Beijing.

And we continue to enjoy that partnership and the co development that we have I would also say that given our global footprint Amgen really is an excellent.

Partner choice with our global capabilities in oncology and general Medicine. So.

So we're open to do business with Chinese companies Japanese companies global companies absolutely.

Erica: Okay, Erica, we're pushing up against the top of the hour, so we'll try to get to all of our questions, but why don't we bring on the next caller?

Okay, Eric we're pushing up against the top of the hour. So we'll try to get to all of our questions but.

When we bring it onto the next caller.

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

Our next question is from Carter Gould with Barclays.

unknown: Great. Good afternoon. Thanks for all the color today.

Yes.

Good afternoon, and thanks for all the color today, maybe just.

David: Maybe just switching gears a bit and moving to BCMA. It sounds like you're about to go back into the clinic. Can you maybe just give us some color on sort of the changes to the protocol or dose escalation, any read through to the broader platform, and just, I guess, focus more specifically on BCMA with those changes, and comment on sort of your competitiveness in an increasingly competitive space? Thank you.

Switching gears, a bit and moving to.

<unk>. It sounds like you are about to go back into the clinic can you maybe just give us some color on sort of the.

Changes to the protocol or dose escalation any any read through to the us.

The broader platform and just I guess.

Focus more specifically on day CMA with those changes comment on sort of your competitiveness in an increasingly competitive space. Thank you.

David: Yeah, Carter, thanks for the question. We do expect to begin dosing again, hopefully, in the next few weeks or so. You know, as you intuited, this would adjust some of the, you know, intrapatient dose escalation that is typical with the use of bite molecules. And so, you know, we'll be pushing, you know, pushing that forward. You know, more broadly, obviously, we want to be able to deliver a program here that can offer something to patients and physicians that they otherwise might not have.

Yes Carter. Thanks for the question. So we do expect to begin dosing again, hopefully in the next few weeks or so.

As you intuitive this wood.

Just some of the <unk>.

Intra patient dose escalation that is typical with the.

Use of bite molecules.

So.

We will be pushing pushing that forward.

More broadly, obviously, we want to be able to deliver.

A program here that can offer something to patients and physicians.

That they otherwise might not have and we will continually assess the program against that.

David: And, you know, we'll continually assess the program against that metric. But, more broadly, I'm quite pleased with the progress we made on AMG 160 and AMG 757. And I, as always, would always provide a cautionary note about extrapolating extensively across programs because much of what we witness in the clinic is target dependent. And so all of these programs will have their idiosyncrasies that need to be worked through as part of the development program.

<unk>.

More broadly.

I'm quite pleased with the progress we made on AMG 160, <unk> and AMG 757.

And as always we're always.

Provide a cautionary note about extrapolating extensively across programs because much of what we witness in the clinic is target dependent and so all of these programs will have their idiosyncrasies that needs to be worked through as part of the development program.

Colin Nigel Bristow: Your next question is from Colin Bristow with UBS.

Your next question is from Colin Bristow with UBS equities.

unknown: And just a quick update from you guys on the business development priorities. What are your current areas of interest? How are you thinking about deal size? And just some overall, I guess, commentary on how you're thinking about valuations in this space. Thanks.

Hi, Good evening. Thank you. Thank you and just a quick update from you guys on the business development priorities. What are your current areas of interest how you're thinking about deal size and just the move will I guess commentary on how youre thinking about valuations in the space.

unknown: Well, Colin, as you know, we've transacted two acquisitions in the first quarter, one at the preclinical stage, and one at the phase three ready stage, and I think that reflects, you know, the breadth of interest that we have. We're continuing to look at acquisitions and licensing opportunities in our stated areas of focus. So, you know, in particular, immunology, inflammatory diseases, cardiovascular diseases, cancer, are attractive to us. And then we have very strong franchises in a few other therapeutic areas, as you know, and in migraine, bone health, and nephrology. So we look for commercial opportunities there.

Well Colin as you know.

Transacted two acquisitions in the first quarter one at the preclinical stage one is a phase III ready and I think that reflects the breadth of interest that we have we're continuing to look at acquisitions and licensing opportunities in our standard areas of focus so.

In particular immunology inflammatory diseases cardiovascular diseases cancer are attractive to us and then we have very strong franchises and a few other therapeutic areas as you know.

And migraine bone health in nephrology, So we look for commercial opportunities there as well.

unknown: Hello, thank you for the question. In terms of protein degradation, obviously, you have a platform that's somewhat early, you know. Any interest in expanding your positioning in that space? Yeah, as we've said before, you know, I think going forward, we would expect the development of what we call the induced proximity platform to depend both on internal innovation and external partnerships and, potentially, acquisition. So we're open to both. We're making a lot of progress there, and we'll provide more detail a bit later. Eric, I gather we have a couple more questions lined up. So we'll take those remaining questions with apologies to the audience that we went over the allotted hour. But let's get the next question.

That's helpful. Maybe just one quick question in contemplation degradation, obviously, you have a platform somewhat early.

Yes.

Any interest in expanding your positioning in that space.

Yes, as we've said before I think going forward, we would expect.

Development of what we call the induced proximity platform to depend both on internal innovation and external partnerships and potential acquisitions. So we're open to both we're making a lot of progress there and we will provide more detail a bit later.

Eric.

Rather we have a couple more questions lined up so we'll take those remaining questions with apologies to the audience that we're going over the allotted hour, let's skip to the next question.

Robyn Kay Shelton Karnauskas: Your next question is from Robyn Karnauskas with Truist.

Your next question is from Robin Cornwell Smith with true.

unknown: Thanks, guys. You addressed a little bit of the moderate severe pressure on the competition for Tesla. Could you, again, address a little bit more now that we have more granular data from Tepenroff and others on the topicals? Do you think the topicals being cheaper might push out some of the uptake of the biologics for Tesla? And then if you want to answer that one, just throw one out here.

Thanks, guys. So you addressed a little bit of the moderate severe.

Pressure on the competition for Tesla could you us.

Again addressed a little bit more now that we have more granular data from compare off and others.

The topical do you think the topical being cheaper might push out some of the uptake in the biologics charge Hezbollah.

Then if you want to answer that one throat went out here you're wanting US first did you Artur application for oncology with all of the FCA.

unknown: You're one of the first to do our tour application for oncology with all the FDA controversy at the moment. Can you just tell us how that's going? Is it proceeding as normal? We're all wondering how that application process will go, because that could be the faster way to market for a lot of new drugs. Thanks. I'll try to get them both quickly.

Diversity Department can you just tell us like.

How that's going is it is it proceeding as normal I think we're all wondering how that how that application process will go because that could be the faster way to market for a lot of new trucks.

I'm trying to get them, both quickly alright, Robin look weak.

unknown: I'll try to get them both quickly. All right, Robyn, look, we think that there's obviously a role for topicals to play for patients with low body surface area involvement in their disease. When it starts to become, you know, a broader surface area or in awkward places on the patient's body, then they're looking for a systemic agent, and they're looking for a safe and effective one. And that's really where we think the mild to moderate opportunity is for OTESLA.

We think that there's obviously a role for topical us to play for patients with low body surface area involvement of their disease when it starts to become.

Broader surface area or an awkward places on the patient's body, then theyre looking for a systemic agent and Theyre looking for a safe and effective one and that's really where we think the mild to moderate opportunity is for <unk>.

unknown: And we, you know, we're not even considering the millions of patients out there with mild to moderate conditions. We're looking at about a 40 to 50% addressable patient population. So we're giving at least half the market as a topical market, assuming the other half would be addressable with an oral. Yeah, and in terms of RTOR or real-time oncology review, what that does is permit submission of tranches of data as you move through the submission process, as opposed to waiting and submitting either a complete file all at once or very large chunks of a file.

We're not even considering.

The millions of patients out there with mild to moderate we're looking at about a 40% to 50% addressable patient population. So we're giving at least half the market as a topical market assuming the other half would be addressable with anoro.

Yeah and in terms of our tour or real time oncology review, what that does us permit submission of tranches of data.

As you move through the submission process as opposed to waiting and submitting either a complete file all at once or very large chunks of a file.

unknown: We've had very productive interactions with the FDA, and in our view, the RTOR process has worked quite nicely here in the longer term, quite frankly. You know, I think that this is the way of the future, not only in oncology but across therapeutic areas for more real-time submission of data, probably from the inception of development programs. Erika, I'd like to take two last questions, please.

We've had very productive interactions with the FDA and in our view.

Our process has worked quite nicely here in the longer term quite frankly, I think that this is the way of the future not only in oncology, but across therapeutic areas for more real time submission of data probably from the inception of development programs.

Eric Let's take two last questions. Please.

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

Hey, Thanks for squeezing me in.

On <unk> recently heard from our K, well, some thoughts with us actually could be a competitive some of your other biologics.

In the high Eosinophil group not just competitive in the.

High unmet need.

Physical market.

Wondering when that data does come out that full publication does come out really what.

We should be looking for in these high voltage <unk> for funds the competitiveness there. Thank you.

Erica: Your next question is from Kenan McKay with RBC Capital Markets.

Yeah.

Thanks, Kevin.

As we've reported as you saw and we will be providing some data updates on additional analyses on the navigators phase III trial at the American Thoracic Society meeting.

Geoffrey Christopher Meacham: Bansal. We'll be providing some data updates and additional analyses on the Navigator Phase 3 trial at the American Thoracic Society meeting in a few weeks now. You know, across the board, we saw efficacy that we think is consistent with first-line use. It's important to understand that there are many patients with severe uncontrolled asthma who have disease that is seeking another treatment right now, meaning they are not controlled with currently available therapies. And so regardless of the acinophil count, you know, we think that the clinical profile of this molecule is quite attractive, and my view continues to be that this is just going to be a really important medicine in asthma for patients. Erika, I've got one last question. Your final question comes from Corey Kasamo with J.P. Morgan.

In a few weeks now.

Across the board we saw.

Efficacy that we think is consistent with first line use saw its important to understand that.

There are many patients with severe uncontrolled asthma or who have disease.

That is seeking another treatment right now, meaning they are not controlled with currently available therapies and so regardless of eosinophil count.

We think that the the clinical profile of this molecule is quite attractive and my view continues to be that this is just going to be a really important medicine in asthma for patients.

Eric Let's take one last question.

Your final question comes from Cory CASM ex.

With J P. Morgan.

Updated <unk> ability to penetrate the blood brain barrier and do you see this as a potential future source of differentiation, one way or the other in the K Russell. Thank you.

Operator: Operator, your final question comes from Corey Kasamo with J.P. Morgan.

unknown: Yeah, Corey, thanks quickly. We're actually, you know, studying specifically lumacrasts in patients with brain metastases. I think the clinical data will be definitive here. And once we've amassed a large enough data set, we'll present that, but it's full speed ahead to answer that question.

Yes, Cory thanks quickly. So we are actually studying specifically <unk> in patients with brain metastases I think the clinical data will be definitive here and once we've.

Massed a large enough dataset will present that but.

It's full speed ahead to answer that question.

Bob Bradway: Okay, well, thank you all for your patience and for dialing into the call today. I'll remind you, as always, that Arvind and his team will be around for several hours still if you have other questions that you didn't get answered, but we appreciate your support and look forward to being back with you in July. Thanks. Thank you, everybody.

Okay, well. Thank you all for your patience and for dialing into the call today.

Mind, you as always that Arvind and his team will be around for several hours still if you net other questions as you didn't get answered.

We appreciate your support and look forward to getting back with you in July.

Thank you everybody.

unknown: This concludes Amgen's first quarter 2021 financial results conference call. You may now disconnect.

This concludes amgen's first quarter 2021 financial results Conference call you may now disconnect.