Q1 2021 Abbvie Inc Earnings Call

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Good morning, and thank you for standing by welcome to the Abbvie first quarter 2021 earnings conference call, all participants will be able to listen only until the question and answer portion of this call. You may ask a question by pressing star one on your phone I would now like to introduce MS. Liz Shea Vice President of the best.

Operator: Good morning, and thank you for standing by. Welcome to the AbbVie First Quarter 2021 Earnings Conference Call. All participants will be able to listen only to the question and answer portion of this call. You may ask a question by pressing star 1 on your phone. I would now like to introduce Ms. Liz Shea,

Liz Shea: President of Investor Relations. Good morning, and thanks for joining us.

Relations.

You may be good morning, and thanks for joining US also on the call with me today are Rick Gonzalez Chairman of the Board and Chief Executive Officer, Michael Severino, Vice Chairman and President, Rob, Michael Executive Vice President and Chief Financial Officer, and Jeff Stuart Executive Vice President commercial operations, joining us for the Q&A portion of the call is Laura.

Liz Shea: Also on the call with me today are Rick Gonzalez, Chairman of the Board and Chief Executive Officer, and Michael Severino, Vice Chairman and President.

Rick Gonzalez: Chairman, Rob Michael, Executive Vice President and Chief Financial Officer, and Geoff Stewart, Executive Vice President, Commercial Operations. Also joining us for the Q&A portion of the call is Laura Schumacher, Vice Chairman, External Affairs, Chief Legal Officer, and Corporate Secretary. Before we get started, I remind you that some statements we make today may be considered forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties. Additional information about these risks and uncertainties.

Marc or Vice Chairman external affairs, Chief legal officer, and corporate Secretary.

Before we get started I remind you that some statements. We make today may be considered forward looking statements for purposes of the private Securities Litigation Reform Act of 1995.

Abbvie cautions that these forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward looking statements.

Information about these risks and uncertainties is included in our SEC filings Abbvie undertakes no obligation to update these forward looking statements except as required by law.

Liz Shea: On today's conference call, non-GAAP financial measures will be used to help investors understand AbbVie's business performance. These non-GAAP financial measures are reconciled with comparable GAAP financial measures in our earnings release and regulatory filings from today, which can be found on our website.

On today's conference call non-GAAP financial measures will be used to help investors understand abbvie.

This performance. These non-GAAP financial measures are reconciled with comparable GAAP financial measures in our earnings release and regulatory filings from today, which can be found on our website.

Liz Shea: Unless otherwise noted, our comments are adjourned.

Unless otherwise noted our commentary on sales growth is on a comparable basis, which includes full current year and historical results for Allergan.

Liz Shea: Commentary on sales growth is on a comparable basis, which includes full current year and historical results for Allergan. For this comparison of underlying performance, all historically reported Allergan revenues have been adjusted

This comparison of underlying performance all historically reported Allergan revenues have been recast to conform to Abbvie is revenue recognition accounting policies and excluded the divestitures of <unk> and biotech references to operational growth further excludes the impact of exchange.

Liz Shea: Recast to conform to AbbVie's Revenue Recognition Accounting Policy and excluded the divestitures of ZENPAP and Biobank.

Liz Shea: and Biocase. References to operational growth further exclude the impact of exchange.

Rick Gonzalez: Following our prepared remarks, we'll take your questions. So with that, I'll now turn the call over to Rick.

Following our prepared remarks, we'll take your questions. So with that I'll now turn the call over to Rick.

Rick Gonzalez: Thank you, Liz, and good morning, everyone.

Thank you Liz good.

Everyone and thank you for joining us today I'll discuss our first quarter performance and outlook and then Jeff Mike and Rob will review, our business highlights pipeline progress and financial results in more detail.

Rick Gonzalez: Thank you for joining us today. I'll discuss our first quarter performance.

Rick Gonzalez: Outlook, and then Geoff, Mike, and Rob will review our business highlights, pipeline progress, and financial results in more detail. We're off to an excellent start this year, delivering strong top and bottom line first quarter performance. We reported adjusted earnings per share of $2.95, exceeding the midpoint of our guidance by 14 cents.

We're off to an excellent start this year delivering strong top and bottom line first quarter performance, we reported adjusted earnings per share of $2 95.

Exceeding the midpoint of our guidance by <unk> 14 cents.

Rick Gonzalez: Total adjusted net revenues of $12.9 billion were up 5.2% on a comparable operational basis, nearly $250 million ahead of our expectations. These results include strong performance across each of our core therapeutic areas, including double-digit comparable operational revenue growth from immunology, neuroscience, and aesthetics, as well as high single-digit operational growth from hematological oncology. Additionally, we continue to see robust sales from our key and newly launched products. Sky Rizzi and Renvo contributed nearly $900 million in combined revenues this quarter, more than double the sales versus the prior year, as both products continue to ramp up in their initial indications. Rubica and Ben Kleksta delivered combined sales of approximately $1.7 billion, reflecting continued leadership in CLL and other hematological malignancies. Baylor, which remains one of the fastest growing medicines in psychiatry, delivered more than 20% compared to

Adjusted net revenues of $12 $9 billion was up five 2% on a comparable operational basis nearly $250 million ahead of our expectations.

These results include strong performance across each of our core therapeutic areas, including double digit comparable operational revenue growth from immunology neuroscience and aesthetics as well as high single digit operational growth from our Hematological oncology.

Additionally, we continue to see robust sales from our key and newly launched products <unk> and <unk> contributed nearly $900 million and combined revenues this quarter more than double the sales versus the prior year as both products continue to ramp in their initial indications.

And we look at and then collect stuff delivered combined sales of approximately $1 7 billion.

Reflecting continued leadership in <unk> and other Hematological malignancies.

Baylor, which remains one of the fastest growing medicines in psychiatry and delivered more than 20% comparable operational growth.

Rick Gonzalez: and Comparable Operational Growth

<unk>, the leading oral <unk> for acute migraine generated revenue growth of approximately 25% on a sequential basis.

Rick Gonzalez: The leading oral CGRP for acute migraine generated revenue growth of approximately 25% on a sequential basis. And within our leading aesthetics portfolio, which is performing well above pre-COVID levels, Botox Cosmetics and Juvederm are demonstrating robust performance. Both of these brands grew more than 40% in a comparable operation.

And within our leading aesthetic portfolio, which is performing well above pre COVID-19 levels Botox cosmetics and juvederm are demonstrating robust performance. Both of these both of these brands grew more than 40% on a comparable operational basis.

Rick Gonzalez: Comparable Operational Base

The integration of Allergan also continues to go very well as illustrated by our balanced results. This quarter. We are clearly demonstrating that we have created a stronger and much more diverse company with the scale and flexibility to fully invest in the business for long term growth.

Rick Gonzalez: The integration of Allergan also continues to go very well. As illustrated by our balanced results this quarter, we are clearly demonstrating that we have created a stronger and much more diverse company. Scale and Flexibility to Fully Invest in the Business for Long-Term Growth. While the pandemic has categorically impacted our day-to-day lives, we are encouraged by the latest recovery trend. C.C.

While the pandemic is categorically impacted our day to day lives. We are encouraged by the latest recovery trends, we see market growth in new patient activity, increasing overall, especially in March although certain markets continue to remain below pre COVID-19 levels, including <unk>.

Rick Gonzalez: Market growth and new patient activity increased overall, especially in March, although certain markets continue to remain below pre-COVID levels, including CLL and HCV in particular. We expect the increasing vaccinations globally will continue to support a full recovery across our therapeutic areas as we progress through the remainder of this year. Based on a robust performance this quarter and the continued strong outlook for our business, we are raising our full-year 2021 EPX guide, and we now expect adjusted earnings per share between $12.37 and $12.57, reflecting growth of more than 18% at the mid-term.

<unk> and <unk> in particular.

We expect the increasing vaccinations globally, we will continue to support a full recovery across our therapeutic areas as we progress through the remainder of this year.

Based on our robust performance this quarter and the continued strong outlook for our business. We are raising our full year 2021, EPS guidance and we now expect adjusted earnings per share between $12 37.

And $12 57.

Reflecting growth of more than 18% at the midpoint.

I'm also extremely pleased with our R&D prospects, including the number and potential of the opportunities, especially within our late stage pipeline we.

Rick Gonzalez: I'm also extremely pleased with our R&D prospects, including the number and potential of the opportunities, especially within our late-stage pipeline. We're on the cusp of the potential commercial approval of more than a dozen new products or indications over the next two years, including five total expected approvals in 2021. This includes ToeJapan, a novel oral CGRP for episodic migraine, adding to our already attractive migraine portfolio.

We're on the cusp of the potential commercial approval of more than it does in new products or indications over the next two years, including five total expected approvals in 2021 is.

This includes a total Japan, a novel oral <unk> for episodic migraine, adding to our already attractive migraine portfolio.

Rick Gonzalez: A new eyedrop for the treatment of presbyopia, as well as expanded indications for RENVO and psoriatic arthritis, ankylosing spondylitis, and atopic dermatitis. And we expect more than half a dozen new product or indication launches in 2022, including Nevitaclax for myelofibrosis. ABBV 951 for advanced Parkinson's disease; Sky Rizzi for psoriatic arthritis and Crohn's disease. Renvo for Ulcerative Colitis, Velar for Major Depressive Disorder, and Additional Indications for Embruvica and Venclexa.

New eye drop for the treatment of presbyopia.

As well as expanded indications for <unk> in Psoriatic arthritis, ankylosing spondylitis and atopic dermatitis.

And we expect more than a half a dozen new product or indication launches in 2022, including <unk> for myelofibrosis ABV 95, one for advanced Parkinsons disease, <unk> for Psoriatic arthritis, and Crohn's disease RIN.

<unk> for ulcerative colitis.

Laura for major depressive disorder, and an additional indications for <unk> and then collect stuff.

Rick Gonzalez: With these collective new growth opportunities and the continued momentum of our underlying portfolio, our long-term outlook remains very strong. In closing, our focus remains on strong commercial and operational execution, as well as pipeline advancement. I'm pleased with the financial results for the quarter and the overall pace of the recovery across our portfolio. We're off to another excellent start in 2021. With that, I'll turn the call over to Bob.

With these collective new growth opportunities and the continued momentum of our underlying portfolio. Our long term outlook, our long term outlook remains very strong.

In closing our focus remains on strong commercial and operational execution as well as pipeline advancement.

I am pleased with the financial results for the quarter and the overall pace of the recovery across our portfolio.

We're off to another excellent start in 2021 with that I will turn the call over to Jeff for additional comments on our commercial highlights Jeff.

Rick Gonzalez: With that, I'll turn the call over to Geoff for additional comments and our commercial highlights. Thank you, Rick.

Thank you, Rick we demonstrated strong and balanced growth across our therapeutic portfolio. This quarter, a testament to our differentiated product profiles and commercial execution, our immunology portfolio delivered global revenues of more than $5 7 billion, reflecting growth of nearly 12% on an operational base.

Geoff Stewart: We demonstrated strong and balanced growth across our therapeutic portfolio this quarter, a testament to our differentiated product profiles. Commercial Execution Our immunology portfolio delivered global revenues of more than $5.7 billion, reflecting growth of nearly 12% on an operational basis. Humira sales were approximately $4.9 billion, up 2.6% on an operational basis, with continued high single-digit growth in the U.S. Offset by biosimilar competition across our international markets, where the unfavorable impact was more moderate than expected in the quarter.

This.

Humira sales were approximately $4 9 billion up two 6% on an operational basis with continued high single digit growth in the U S offset by Biosimilar competition across our international markets, where the unfavorable impact was more moderate than expected in the quarter.

Our new immunology agents <unk> and <unk> are both demonstrating robust prescription growth well above all comparable launches.

Geoff Stewart: Our new immunology agents, Skyrizzy, and RINVOC, are both demonstrating robust prescription growth, well above all comparable launches. Skyrizzy sales were $574 million, reflecting 34% in-play patient, which includes new and switching. This is more than double the share capture of the next nearest biologic competitor. Guy Rizzi's total prescription share in the U.S. psoriasis biologic market is now approximately 15%, second only to Humira. Additionally, we recently received approval for a single-dose pre-filled pen for Sky, which will reduce the number of injections per treatment. Guy Rizzi is now the only quarterly dose psoriasis treatment available in an auto-injector, further improving the patient experience.

<unk> sales were $574 million, reflecting 34% in play patient share, which includes new and switching patients. This is more than double the share capture of the next nearest biologic competitor.

<unk> total prescription share in the U S. Psoriasis biologic market is now approximately 15% second only to Humira.

Additionally, we recently received approval for a single dose Prefilled pen for <unk>, which will reduce the number of injections per treatment.

<unk> is now the only quarterly dose psoriasis treatment available in an auto injector further improving the patient experience.

<unk> sales were $303 million with strong in play patient share of approximately 15% in the U S or a market.

Geoff Stewart: Renvoke sales were $303 million, with strong in-play patient share of approximately 15% in the USRA market. Physician and patient feedback remained very positive on RINVO's level of efficacy, speed of response, and strong benefit-risk profile. Internationally, both of these new assets delivered strong double-digit sequential growth with ramping access and share.

Physician and patient feedback remains very positive on <unk> level of efficacy speed of response and strong benefit risk profile.

Internationally both of these new assets delivered strong double digit sequential growth with ramping accessing share.

Guy Ritchie has now also achieved in play patient share leadership in the EU five psoriasis market exceeding from fire and <unk> and at parity with pulse.

Geoff Stewart: Guy Rizzi has now also achieved in-play patient share leadership in the EU5 psoriasis market, exceeding FIAA and Cosentix and at parity with TALC. As Mike will discuss momentarily, we are also making considerable progress to expand the uses of Skyrizzian-Rinvoke in several immune-mediated diseases, with half a dozen additional indication approvals expected later this year and in 2020. In hematologic oncology, sales were approximately $1.7 billion, up 7.3% on an operational basis. And Rubica continues to perform well across multiple indications, including CLL, where it remains the clear market share leader across all lines of therapy.

As Mike will discuss momentarily. We are also making considerable progress to expand the uses of <unk> and <unk> in several immune mediated diseases with half a dozen additional indication approvals expected later this year and in 2022.

In hematologic oncology sales were approximately $1 7 billion up seven 3% on an operational basis <unk> continues to perform well across multiple indications, including CLO, where it remains the clear market share leader across all lines of therapy.

<unk> sales increased two 9% on an operational basis this quarter with performance impacted by lower new patient starts within CLO, where the market remains below pre COVID-19 levels in.

<unk> growth was also unfavorably impacted by the COVID-19 related stocking benefit that we saw in the first quarter of 2020.

Geoff Stewart: The Bruvica sales increased 2.9% on an operational basis this quarter, with performance impacted by lower new patient starts within CLL, where the market remains below pre-COVID, Rubica growth was also unfavorably impacted by the COVID-related stocking benefits, saw in the first quarter of, And Clexta sales were $405 million, up 24.5% on an operational basis, with increasing share in Frontline CLL and continued strong performance in AIM. Neuroscience.

<unk> sales were $405 million up 24, 5% on an operational basis with increasing share in frontline <unk> and continued strong performance in AML.

In neuroscience revenues were more than $1.2 billion up 10, 9% on a comparable operational basis <unk> once again delivered strong growth.

<unk> of $346 million were up 21, 2% on a comparable operational basis, reflecting a nearly two 5% total prescription share of the U S atypical antipsychotic market.

Within migraine the launch of your <unk> is exceeding our expectations with $81 million of revenue in the quarter feed.

Feedback from physicians has been very positive highlighting <unk> efficacy safety convenient dosing profile and overall commercial access.

Geoff Stewart: Revenues were more than $1.2 billion, up 10.9% on a comparable operational basis. Graylar once again delivered strong growth. Sales of $346 million were up 21.2% on a comparable operational basis, reflecting a nearly 2.5% total prescription share of the U.S. atypical anti-psychotic market. Within Migraine, the launch of Ubrelvi is exceeding our expectations, with $81 million of revenue in the quarter. Feedback from physicians has been very positive, highlighting Ubrelvi's efficacy, safety, convenient dosing profile, and overall commercial accuracy. Ubrelvi is the number one branded acute treatment for migraine based on both new patient share and prescription growth.

<unk> is the number one branded acute treatment for migraine based on both new patient share and prescription growth.

The oral <unk> therapies, including our leading <unk> now represent roughly 16% of new prescriptions and the large acute migraine market.

We believe there is substantial room for long term growth in this rapidly expanding segment based on unmet need and strong patient demand.

We also look forward to the expected commercial approval of a toll Japan, our oral <unk> for episodic migraine later this year.

Botox therapeutic is seeing a very nice recovery in chronic migraine as well as its other indications with total sales of $532 million up 7% on a comparable operational basis.

Lastly in our other key therapeutic areas we.

Geoff Stewart: The oral CGRP therapies, including our leading Ubrelvi, now represent roughly 16% of new prescriptions in the large acute migraine market. We believe there's substantial room for long-term growth in this rapidly expanding segment based on unmet need and strong... We also look forward to the expected commercial approval of ToeJapan, our oral CGRP therapy for episodic migraine, later this year. Botox Therapeutic is seeing a very nice recovery in chronic migraine, as well as other indicators. Total sales of $532 million, up 7% on a comparable operation.

We saw significant contribution from eyecare, which had revenues of $817 million Maverick sales were 415 million.

Down 28, 4% on an operational basis as treated patient volumes have remained below pre COVID-19 levels and.

And we also saw double digit comparable growth from Linzess, the leading branded prescription medicine in the U S for the treatment of adults with Ibs C or chronic idiopathic constipation.

Overall I'm extremely.

<unk> pleased with our execution across the therapeutic portfolio, including the progress, we're making with recent new product launches. We remain on track to deliver a very strong revenue growth in 2021, and with that I'll turn the call over to Mike for additional comments on our R&D programs Mike.

Geoff Stewart: Lastly, in our other key therapeutic areas, we saw significant contribution from iCare, which had revenues of $817 million. Maverick sales were $415 million.

Thank you Jeff.

I'll start with immunology, where we continue to make good progress with <unk> and <unk> in new disease areas as well as in our early and mid stage immunology programs.

We recently reported positive top line results from the second induction study for <unk> in ulcerative colitis.

Geoff Stewart: Down 28.4% on an, As treated patient volumes have remained below pre-COVID, and we also saw double-digit comparable growth from Linzess, the leading branded prescription medicine in the U.S. for the treatment of adults with IBSC or chronic idiopathic. Overall, Extremely pleased with our execution across the therapeutic portfolio, including the progress we are making with our recent new product. We remain on track to deliver very strong revenue With that, I'll turn the call over to Mike for additional comments on our R&D. Thank you, Geoff.

Similar to results from the first induction study in this phase III trial revoke demonstrated a very strong impact on disease activity as measured by clinical remission clinical response and endoscopic improvement.

The 45 milligram induction dose was well tolerated and the safety profile was consistent with previous <unk> studies.

In these induction trials, we saw no DVT PE mace events for malignancies in the RIN vote groups and the rates of serious adverse events were numerically lower than placebo.

We believe these induction data compare very favorably to other UC treatments on the market or in development and based on the data generated to date <unk> has the potential to become one of the most highly effective therapies for patients with moderate to severe ulcerative colitis.

Mike Severino: I'll start with immunology, where we continue to make good progress with Rinvoke and Skyrizzy in new disease areas, as well as in our early and mid-stage immunology programs. We recently reported positive top-line results from the second induction study for RINVOC and ulcerative colitis. Similar to results from the first induction study, in this Phase 3 trial, RINVOC demonstrated a very strong impact on disease activity, as measured by clinical remission, clinical response, and endoscopic improvement.

We expect to see results from the UC maintenance study this summer.

With regulatory submissions anticipated in the second half of the year.

The <unk> program in Crohn's disease is also progressing very well and we expect to see induction data from the first of two phase III trials in the fourth quarter, followed by induction data from our second phase III trial and maintenance data in the first half of 2022.

We're also nearing completion of our pivotal program for <unk> in Crohn's disease.

Mike Severino: The 45 mg induction dose was well tolerated, and the safety profile was consistent with previous RENVOGUE studies. In these induction trials, we saw no DBT, PE, MACE events, or malignancies in the RINVOTE groups, and the rates of serious adverse events were numerically lower than placebo.

Earlier this year, we reported positive results from the two Crohn's induction studies and we expect to see maintenance data this summer our.

Our regulatory submissions for <unk> in Crohn's disease remain on track for the second half of 2021.

Following completion of our Registrational program for <unk> in Psoriatic arthritis, we recently submitted our regulatory applications in the U S and Europe with approval decisions expected in the first half of 2022.

Mike Severino: We believe these induction data compare very favorably to other UC treatments on the market or in development, and based on the data generated to date, RINVOC has the potential to become one of the most highly effective treatments for patients with moderate to severe ulcerative colitis. We expect to see results from the UC maintenance study this summer. With regulatory submissions anticipated in the second half of the year. The RINVOKE program in Crohn's disease is also progressing very well, and we expect to see induction data from the first of two phase three trials in the fourth quarter, followed by induction data from a second phase three trial and maintenance data in the first half of 2022.

We're very pleased with the level of activity, we saw with Sky Rizzi on both joint disease, and skin clearance and our phase III program and look forward to providing this new treatment to patients suffering from Psoriatic arthritis.

Our regulatory submissions are currently under review for invoke in three new indications in the U S.

Ankylosing spondylitis, psoriatic arthritis, and atopic dermatitis.

As we previously announced the FDA recently extended the review periods for invoke in Psoriatic arthritis, and atopic dermatitis. Following our request for an updated assessment of the benefit risk profile for <unk> in these indications.

Mike Severino: We're also nearing completion of our pivotal program for Sky RISD in Crohn's. Earlier this year, we reported positive results from the two Crohn's induction studies, and we expect to see maintenance data this summer. Our regulatory submissions for Skyrizian for Crohn's disease remain on track for the second half of 2021. Following completion of our registrational program for SCIRIS-E in psoriatic arthritis, we recently submitted our regulatory applications in the U.S. and Europe, with approval decisions expected in the first half of 2022.

In response to the FDA request, we provided updated data from across invoke programs and RA psoriatic arthritis, and atopic dermatitis.

Based on the review extensions, we now expect approval decisions for Psoriatic arthritis in June and for atopic dermatitis in July.

The regulatory action date per invoke in ankylosing spondylitis is unchanged and remains on track for June.

We remain confident in the benefit risk profile of <unk> across all indications and we will work with the FDA to bring <unk> to market and these new disease areas.

Mike Severino: We're very pleased with the level of activity we saw with SCIRIS-E on both joint disease and skin clearance in our Phase 3 program and look forward to providing this new treatment to patients suffering from psoriatic arthritis. Our regulatory submissions are currently under review for RINVOC in three new indications in the U.S. for Ankylosing Spondylitis, Psoriatic Arthritis, and Atopic Dermatitis. As we previously announced, the FDA recently extended the review periods for RINVOC in psoriatic arthritis and atopic dermatitis following a request for an updated assessment of the benefit-risk profile for RINVOC in these indications.

Earlier this year, we received European approval for invoke in Psoriatic arthritis and SaaS.

Our European regulatory application for <unk> in atopic dermatitis is under review and we remain on track for the HMP opinion. This summer with an approval decision anticipated in the third quarter.

We also recently saw results from a four week phase <unk> study evaluating our novel small molecule ror Gamma T inverse agonist ABV $1 57 in patients with psoriasis.

By targeting Ror Gamma T with an inverse agonist rather than an antagonist. We believe we can more effectively inhibit IL 17 production, thus, resulting in a greater impact on skin inflammation.

Mike Severino: In response to the FDA request, we provided updated data from across the RINVOKE programs in RA, psoriatic arthritis, and atopic dermatitis. Based on the review extensions, we now expect approval decisions for psoriatic arthritis in June and for atopic dermatitis in July. The regulatory action date for RINVOC and ankylosing spondylitis is unchanged and remains on track for June.

In our phase <unk> study $105 seven showed promising activity as an oral psoriasis agent and we plan to move the asset forward to a larger phase <unk> dose ranging study in the second half of this year.

Moving now to our oncology portfolio.

Mike Severino: We remain confident in the benefit-risk profile of RINVOC across all indications and will work with the FDA to bring RINVOC to market in these new disease areas. Earlier this year, we received European approval for Renvokin's psoriatic arthritis product, NAS. Our European regulatory application for RINVOC in atopic dermatitis is under review, and we remain on track for a CHMP opinion this summer, with an approval decision anticipated in the third quarter. We also recently saw results from a four-week Phase 1B study evaluating our novel small molecule ROR gamma-T inverse agonist. ABDV 157 inpatients with psoriasis.

We continue to make very good progress with our late stage programs for <unk>, <unk> and <unk> as well as with our early stage oncology assets.

We remain on track for several key regulatory submissions data presentations and phase transitions this year.

At the upcoming <unk> and <unk> meetings, we will be presenting more than 40 abstracts, including results from the <unk> plots of <unk> debt captivate trial fixed duration cohort in treatment naive CLI patients.

The improved <unk> then collects the combination is an important element of our hemo on strategy to provide a differentiated fixed duration treatment that offers deeper levels of response.

Data from our <unk> and <unk> combination studies will support regulatory submissions in frontline CLO later this year.

Mike Severino: By targeting ROR gamma-T with an inverse agonist rather than an antagonist, we believe we can more effectively inhibit IL-17 production, thus resulting in a greater impact on skin inflammation. In our Phase 1b study, 157 showed promising activity as an oral psoriasis agent, and we plan to move the asset forward to a larger Phase 2b dose-ranging study in the second half of this year. Moving now to our oncology portfolio, we continue to make very good progress with our late-stage programs for embruvica, then clexta, and viticlax, as well as with our early-stage oncology assets.

We will also be presenting four year follow up data from the <unk> CLO 14 trial in frontline <unk>.

As well as updated efficacy and safety data from our phase <unk> study evaluating <unk> plus <unk> in treatment naive high risk Mds patients.

We expect this Mds study to complete in the second half of this year and if positive it could support a submission in the first half of 2022 to seek an accelerated approval.

In the area of solid tumors at the recent ACR meeting, we presented phase II results for <unk> in non squamous non small cell lung cancer.

Mike Severino: We remain on track for several key regulatory submissions, data presentations, and phase transitions this year. At the upcoming ASCO and EHA meetings, we will be presenting more than 40 abstracts, including results from the Imbruvica Placidin-Clextec Captivate Trial, a fixed-duration cohort, in treatment-naive CLL patients.

In this study <unk> demonstrated promising response rates in heavily pretreated patients, particularly in patients with highly express <unk>, where we saw a 54% objective response rate.

<unk> is an attractive target across multiple tumor types, particularly in non small cell lung cancer, where approximately 30% of patients have over express <unk>.

Mike Severino: The Imbruvica-venclexa combination is an important element of our HEMON strategy to provide a differentiated, fixed-duration treatment that offers deeper levels of response. Data from our Imbruvica-venclexa combination studies will support regulatory submissions in frontline CLL later this year. We will also be presenting four-year follow-up data from BenClexta's CLL14 trial in frontline CLL, as well as updated efficacy and safety data from a Phase 1B study evaluating BenClexta plus azacitidine in treatment-naive, high-risk MDS patients.

Approaches in this area have historically focused on small molecule kinase inhibitors and anti <unk> antibodies, both of which have shown only limited efficacy in this patient population that has not been sufficient for approval.

In contrast, our cement antibody drug conjugate is a novel approach that we believe will have broader applicability and will provide enhanced efficacy compared to previous approaches.

We recently began the second stage of our phase II study, which has the potential to support an accelerated approval in second line plus metastatic non squamous non small cell lung cancer.

Mike Severino: We expect this MDS study to complete in the second half of this year, and if positive, it could support a submission in the first half of 2022 to seek an accelerated approval in the area of solid tumors. At the recent AACR meeting, we presented Phase 2 results for TELUSO-V in non-squamous, non-small cell lung cancer.

We also plan to evaluate <unk> in the frontline setting, including in combination with other agents as well as in other <unk> positive tumor types.

We also have a next generation <unk> ADC program that will be entering the clinic later this year.

Our new C met ADC ABV 400 utilizes a telco isomerase inhibitor payload, which we believe will provide greater anti tumor efficacy against both amplified Matt and over expressed <unk> subtypes.

Mike Severino: In this study, TELUSO-B demonstrated promising response rates in heavily pre-treated patients, particularly in patients with highly expressed C-MET, where we saw a 54% objective response rate. CMET is an attractive target across multiple tumor types, particularly in non-small cell lung cancer, where approximately 30% of patients have overexpressed CMET.

Providing deeper responses with broader applicability than other anti <unk> targeting agents.

In neuroscience, we recently presented data from several key programs at the American Academy of Neurology annual meeting or.

Mike Severino: Approaches in this area have historically focused on small-molecule kinase inhibitors and anti-CMIT antibodies, both of which have shown only limited efficacy in this patient population and have not been sufficient for approval. In contrast, our CMET antibody drug conjugate is a novel approach that we believe will have broader applicability and will provide enhanced efficacy compared to previous approaches. We recently began the second stage of our Phase II study, which has the potential to support an accelerated approval in second-line plus, metastatic, non-squamous, non-small cell lung cancer.

A total of 33 abstracts were presented including.

Data from the Phase III advance study in episodic migraine prevention, showing that <unk> has the potential to be a highly effective safe and well tolerated oral treatment option with a rapid onset of action.

The FDA recently accepted our NDA for <unk> for the prevention of episodic migraine and an approval decision is expected in September of this year.

We also presented results from an open label Phase III study evaluating <unk> and Peri menstrual migraine.

Which showed that <unk> has potential as a safe and efficacious treatment of migraine attacks that occurred during or near menstruation.

Mike Severino: We also plan to evaluate TELUSO-V in the frontline setting, including in combination with other agents, as well as in other C-met positive tumor types. We also have a next generation CMET ADC program that will be entering the clinic later this year. Our new CMET ADC, ABBV400, utilizes a topoisomerase inhibitor payload, which we believe will provide greater antitumor efficacy against both amplifified MET and overexpressed CMET subtypes.

Menstrual related migraine attacks can be more difficult to treat because they are often longer in duration more severe and often resistant to treatment.

And we presented data from our phase one study demonstrating that <unk> 95, one subcutaneous infusion maintain an equivalent levodopa exposure to duopoly in advanced Parkinson's patients.

Results from the pivotal program for ABV 95, one are expected this summer with the regulatory submissions anticipated in the second half of this year.

We also remain on track to read out in the fourth quarter from two phase III studies for <unk> in adjunct and major depressive disorder, and if successful we would anticipate regulatory submissions in the first half of 2022.

Mike Severino: Thus providing deeper responses with broader applicability than other anti-CMAT targeting agencies. In neuroscience, we recently presented data from several key programs at the American Academy of Neurology annual meeting. A total of 33 abstracts were presented, including data from the Phase 3 ADVANCE Study in Episodic Migraine Prevention showing that Etojapant has the potential to be a highly effective, safe, and well-tolerated oral treatment option with a rapid onset of action. The FDA recently accepted our NDA for Itojipan for the prevention of episodic migraine, and an approval decision is expected in September of this year.

In eye care, we submitted our regulatory application in the U S for AGN 190584 for the treatment of symptoms associated with presbyopia.

<unk> four is a once daily eye drop being developed to help address symptoms that are often corrected through reading glasses.

This new technology represents a complementary product to reading glasses and would be a convenient on demand solution for patients with mild to moderate presbyopia.

An approval decision is expected in the fourth quarter of this year.

And in aesthetics.

Mike Severino: We also presented results from an open-label Phase III study evaluating Ubrella V in perimenstrual migraines, which showed that Ubrovi has potential as a safe and efficacious treatment for migraine attacks that occur during or near menstruation. Menstrual migraine attacks can be more difficult to treat because they are often longer in duration, more severe, and often resistant to treatment.

We're investing to accelerate key next generation toxins and filler programs.

By combining the aesthetic team's deep expertise with Abbvie is breadth and scale of resources, we'll be able to bring novel products to market significantly faster.

Looking across our portfolio, we've identified a number of programs to accelerate including our short acting and long acting toxins as well as our next generation bio stimulatory Triple elastin and collagen fillers.

Mike Severino: And we presented data from a phase one study demonstrating that ABBV951 subcutaneous infusions maintain an equivalent levodopa exposure to duopa in advanced Parkinson's patients. Results from the pivotal program for ABBV 951 are expected this summer, with regulatory submissions anticipated in the second half of this year. We also remain on track for readouts in the fourth quarter from two phase three studies for Braylor, an adjunctive treatment for major depressive disorder. If successful, we would anticipate regulatory submissions in the first half of 2022.

Acceleration of these programs is expected to drive significant long term growth for the aesthetics franchise.

So in summary, we've continued to make significant progress with our pipeline to start the year and we look forward to many more data readouts regulatory submissions and approvals throughout the remainder of 2021.

With that I'll turn the call over to Rob for additional comments on our first quarter performance and financial outlook, Rob. Thank you, Mike starting with first quarter results, we reported adjusted earnings per share of $2 95.

Up 21, 9% compared to prior year and above our guidance midpoint.

Mike Severino: In eye care, we submitted our regulatory application in the U.S. for AGN 190584 for the treatment of symptoms associated with presbyopia. 584 is a once daily eyedrop being developed to help address symptoms that are often corrected through reading glasses. This new technology represents a complementary product to reading glasses and would be a convenient, on-demand solution for patients with mild to moderate presbyopia.

Total adjusted net revenues were $12 $9 billion.

Up five 2% on a comparable operational basis, excluding a one 1% favorable impact from foreign exchange.

The adjusted operating margin ratio was 51% of sales an improvement of 120 basis points versus the prior year. This includes adjusted gross margin of 83, 9% of sales adjusted R&D investment of 11, 6% of sales and adjusted SG&A expense of 21, 2% of sales.

Mike Severino: An approval decision is expected in the fourth quarter of this year, and Anesthetics. We're investing to accelerate key next-generation toxins and filler programs. By combining the aesthetic team's deep expertise with AbbVie's breadth and scale of resources, we'll be able to bring novel products to market significantly faster. Looking across our portfolio, we've identified a number of programs to accelerate, including our short-acting and long-acting toxins, as well as our next-generation biostimulatory tropoelastin and collagen fillers.

Net interest expense was $622 million and the adjusted tax rate was 12, 3%.

As Rick previously mentioned, we are raising our full year adjusted earnings per share guidance to between $12 37 and.

And $12 57.

Reflecting growth of 18, 1% at the midpoint excluded from this guidance is $5.10 of.

Of known intangible amortization and specified items.

This guidance now contemplates full year revenue growth of nine 8% on a comparable operational basis at current rates. We continue to expect foreign exchange to have a 1% favorable impact on full year comparable sales growth.

Mike Severino: Acceleration of these programs is expected to drive significant long-term growth for the aesthetics franchise. So, in summary, we've continued to make significant progress with our pipeline to start the year, and we look forward to many more data readouts, regulatory submissions, and approvals throughout the remainder of 2021. With that, I'll turn the call over to Rob for additional comments on our first quarter performance and financial outlook. Rob, thank you, Mike.

This implies a full year revenue forecast of approximately $55 9 billion.

Included in this guidance are the following updated full year assumptions, we now expect international Humira revenue of approximately $3 1 billion.

Robert A. Michael: Starting with first quarter results, we reported adjusted earnings per share of $2.95, up 21.9% compared to the prior year and above our guidance midpoint. Total adjusted net revenues were $12.9 billion, up 5.2% on a comparable operational basis, excluding a 1.1% favorable impact from foreign exchange. The adjusted operating margin ratio was 51% of sales, an improvement of 120 basis points versus the prior year. This includes adjusted gross margin of 83.9% of sales, adjusted R&D investment of 11.6% of sales, and adjusted SG&A expense of 21.2% of sales.

And we now expect botox cosmetic sales of approximately $1 9 billion.

All other full year assumptions remain unchanged.

As we look ahead to the second quarter, we anticipate net revenue approaching $13 6 billion at current rates, we expect foreign exchange to have a one 6% favorable impact on comparable sales growth.

We expect adjusted earnings per share between $3 <unk>.

And $3 nine.

Excluding approximately $1 78.

Of known intangible amortization and specified items.

Finally, we continue to make great progress on our Allergan transaction commitments, we realized over $360 million of expense synergies in the first quarter and are on track to deliver synergies of approximately $1 7 billion in 2021 and greater than $2 billion in 2002.

92.

Robert A. Michael: Net interest expense was $622 million, and the adjusted tax rate was 12.3%. As Rick previously mentioned, we are raising our full-year adjusted earnings per share guidance to between $12.37 and $12.57, reflecting growth of 18.1% at the midpoint. Excluded from this guidance is $5.10 of known intangible amortization and specified items.

We have already paid down $10 $4 billion of combined company debt. We continue to expect cumulative debt paydown of $17 billion by the end of 2021 with further deleveraging through 2023. This will bring our net leverage ratio to two four times by the end of 2021 and approximately two.

Times by the end of 2022.

In closing we are off to an excellent start to the year with strong performance across the portfolio and financial results ahead of our expectations.

With that I'll turn the call back over to Liz.

Thanks, Rob we will now open the call for questions and the interest of hearing from as many analysts as possible over the remainder of the call. We ask that you. Please limit your questions to one or two.

Robert A. Michael: This guidance now contemplates full-year revenue growth of 9.8% on a comparable operational basis. At current rates, we continue to expect foreign exchange to have a 1% favorable impact on full-year comparable sales growth. This implies a full year revenue forecast of approximately $55.9 billion. Also included in this guidance are the following updated full year assumptions. We now expect international HUMERA revenue of approximately $3.1 billion, and we now expect Botox cosmetic sales of approximately $1.9 billion. All other FOIA assumptions remain unchanged.

Operator first question please.

Our first question comes from Chris Schott with Jpmorgan. Your line is open.

Great. Thanks, so much for the questions.

First one for me was on <unk> and dose.

If you think about F T I guess balancing low.

Effective dose versus incremental efficacy and safety risks I guess, what would the impact of only having a 15 milligram versus a 15 and 30 milligram approval have on your view on the atopic derm opportunity, which I think you've talked about it's about a $2 billion sales potential previously and then my second question was just a little bit more color on this.

So the dynamics I guess is there anything we're seeing with the results. We're seeing very very strong here is there any catch up type of event as the world Reopens that we're seeing with these results.

Robert A. Michael: As we look ahead to the second quarter, we anticipate net revenue approaching $13.6 billion. Additionally, at current rates, we expect foreign exchange to have a 1.6% favorable impact on comparable sales growth. We expect adjusted earnings per share between $3.05 and $3.09, excluding approximately $1.78 of known intangible amortization and specified items. Finally, we continue to make great progress on our Allergan transaction commitment. We realized over $360 million in expense synergies in the first quarter and are on track to deliver synergies of approximately $1.7 billion in 2021 and greater than $2 billion in 2022.

Or are these kind of sustainable underlying trends that are kind of coming in above expectations for that business to try to get a sense of just how to think about that progressing as we go through the rest of the year. Thanks, so much.

So thanks, Chris This is Mike I'll take the first question and then Rick will take the second question that you asked.

With respect to RIN book, we feel very confident in the benefit risk profile across indications and across the doses that we've study having said that both the 15 and 30 milligram doses have performed very well both from an efficacy and a safety perspective, and so if you look at the efficacy results that we drove with 15.

<unk> in atopic dermatitis, we drove high levels of response very rapid response and had a very prominent impact on itch, which is one of the most bothersome symptoms with 15 as well as with 30 and with the 15 milligram dose for example, we saw statistically.

Robert A. Michael: We have already paid down $10.4 billion of combined company debt. We continue to expect a cumulative debt paydown of $17 billion by the end of 2021, with further deleveraging through 2023. This will bring our net leverage ratio to 2.4 times by the end of 2021 and approximately two times by the end of 2022. In closing, we are off to an excellent start to the year, with strong performance across the portfolio and financial results ahead of our expectations. With that, I'll turn the call back over to Liz.

Statistically significant and clinically significant reduction in niche after only two days, which is really quite remarkable in this disease and again, that's really one of the most bothersome symptoms to patients. So we think we can be successful with either dose to answer your question specifically, but we also remain confident in the benefit risk of both doses.

So Chris this is Rick I'll cover the aesthetics, one for you as Mike said I think if you look at the underlying performance of these steady business in particular, the market growth in the U S and in China, It's driving the fundamental growth that we've seen through the business.

Certainly there is some impacts still from.

From COVID-19, so we're seeing some impact there, but I think the majority of it is when we took over.

Allergan, we made a decision to really invest in promotion at a much higher level than they were investing in a prior and they had an approach that was more of an episodic investment approach, where we have basically made a decision that will fund across the entire year at a relatively significant level to <unk>.

Liz Shea: Thanks, Rob. We will now open the call for questions. In the interest of hearing from as many analysts as possible over the remainder of the call, we ask that you please limit your questions to one or two. Operator, first question, please.

<unk> demand because the data clearly supports that you can grow this market.

I think the best comparisons start to look at what it looks like versus 2019, because you obviously have the COVID-19 impact in 2020.

Operator: Our first question comes from Chris Schott with J.P. Morgan. Your line is open.

But you take for example, botox Botox versus 2019 cosmetic botox versus 2019 is up about 27%.

Chris Schott: Great. Thanks so much for the questions. The first one for me was on RINVOC and dose.

The market is growing very robustly some of that is probably COVID-19 driven these are U S numbers I'm describing right now.

Chris Schott: As we think about FDA, I guess, balancing the lowest effective dose versus incremental efficacy and safety risks, I guess, what would the impact of only having a 15 milligram versus a 15 and 30 milligram approval have on your view of the atopic derm opportunity, which I think you talked about as about a $2 billion sales potential previously? And then my second question was just a little bit more color on the aesthetic dynamics. I guess, is there anything we're seeing with the results that seems very, very strong here? Is there any catch-up type event as the world reopens that we're seeing with these results?

Some of that is probably COVID-19, driven but I wouldn't say a lot of it at this point.

Revenue in the U S.

China continues to grow very well in fact, I'd say, China is back to the level of growth and we have expanded the sales force in China once about four or five months ago. We are in the process now of going through a second expansion in China I would expect that China will continue to drive significant growth going forward.

One area that still is being impacted in a in a fairly significant way from COVID-19 is the European market.

We still see it.

Starting we see it starting to emerge in areas like the U K, but there are other areas in Europe.

Still in Lockdown.

I would expect that Europe, and Brazil, as well will hopefully starting to see some recover as we get into the second half of this year and they can start to contribute which would add additional growth to the overall business, but I would tell you I'm very pleased with.

Chris Schott: Or are these kind of sustainable underlying trends that are kind of coming in above expectations for that business? Trying to get a sense of just how to think about that progressing as we go through the rest of the year. Thanks so much. So, Chris. This is Mike.

The decisions, we've made around driving more promotion and I'm pleased with the execution of this team. This team has done extremely well.

In executing and driving the kind of share position that we want and the growth that we want so I think it is sustainable going forward.

Mike Severino: I'll take the first question, and then Rick will take the second question that you asked. With respect to RINVOKE, we feel very confident in the benefit-risk profile across indications and across the doses that we've studied. Having said that, both the 15 and 30 milligram doses performed very well, both from an efficacy and safety perspective. And so if you look at the efficacy results that we drove with 15 in atopic dermatitis, we drove high levels of response, very rapid response, and had a very prominent impact on itch, which is one of the most bothersome symptoms with 15, as well as with 30.

Thanks, Chris Operator next question please.

Yes. Our next question comes from Geoffrey Porges with SBB Leerink. Your line is open thank.

Thank you very much I appreciate it a couple of questions.

First Rick something we don't talk about a lot, which is the neuroscience portfolio and you saw the reporting it.

I know this flow of product in there, but adding them up the long term guidance. You provided previously was about $8 3 billion I think Andrew.

We're already Annualizing at close to six so could you give us a sense of how much upside that.

Portfolio has given the trends that youre seeing and then sort of on a related question.

I hate to harp on the channel question, but obviously, there's a lot coming to us.

What this impact might be so if you work confined to the 15 milligram dose not because of any signal, but because of the regulators. This view of the safety of the class.

Mike Severino: And with a 15 milligram dose, for example, we saw a statistically significant and clinically significant reduction in itch after only two days, which is really quite remarkable. And again, that's really one of the most bothersome symptoms to patients. So we think we could be successful with either dose, to answer your question specifically. But we also remain confident in the benefit risk of both. So Chris, this is Rick.

How much impact would that have on the 8 billion long term guidance and do you have other levers that you could pull to fill or whatever shortfall that would cause.

On the neuroscience portfolio. It is an area that we're very excited about so maybe maybe Jeff and I will tag team here, but I think when you look at the two major growth franchises there.

The migraine franchise and Ami.

Anti psychotic franchise with Baylor both of those we think have significant opportunity to continue to grow I mean, you're obviously seeing revenue now.

Rick Gonzalez: I'll cover the aesthetics one for you. As Mike said, I think if you look at the underlying performance of the aesthetics business, in particular, market growth in the US and in China, it's driving the fundamental growth that we see through the. Certainly, there is some impact still.

Perform extremely well in the marketplace.

Jeff can give you probably a little more color on that and very low is continuing to perform very well as well.

I think if we are able to achieve.

One positive study on M. D. D. I think that will give us significant growth going forward. So this is a franchise that we're excited about I think it will be a meaningful franchise for us over the long term scenario, where you continue to look at assets that you could potentially add to it.

Rick Gonzalez: I think the majority of it was when we took over.

Rick Gonzalez: Alargan. We made a decision to really invest in promotion at a much higher level than they had invested in it prior, and they had an approach that was more

And I think it will be a nice growth driver for us Geoff Yes, I think just to reiterate as I mentioned in my comments the oral <unk> market is moving very nicely.

Rick Gonzalez: And I think the best comparisons are to start to look at what.

Hit I mentioned, 16% for the quarter, but now on the weekly that 17 or above on just the penetration of that segment and so we see a lot of runway.

Rick Gonzalez: What it looks like versus 2019, because you obviously have the COVID impact in 2020. But you take, for example, Botox; Botox versus 2019.

In that in that segment over our long range planning certainly the availability of of another oral <unk> in this case for episodic migraine allows us to compete in a in a much larger segment beyond the acute.

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Rick Gonzalez: The market's growing very robustly. Some of that is probably COVID-driven, these are U.S. numbers right now. Some of that is probably COVID-driven, but I wouldn't say a lot of it at this point is. China continues to grow very well; in fact, I'd say China's back to its level of growth.

And to Rick's point remember, we have the big anchor asset with botox therapeutic and migraine on the backend for chronic migraine and we have plans in place to expand that upstream also into episodic migraine and this is actually in some ways non overlapping because we have a big injector base for Botox and then we can have.

Rick Gonzalez: We expanded the sales force in China once, about four or five months ago. We're in the process now of going through a second expansion in China. I would expect that China will continue to drive significant growth going forward. One area that is still being impacted in a fairly significant way from COVID is

The neurologists and primary care base for tow, Japan, and so when you look basically really across the waterfront leading acute agents.

Unknown Speaker: [inaudible]

Rick Gonzalez: We expect that Europe and Brazil as well will hopefully start to see some recover as we get into the second half of this year, and they can start to contribute, which would add additional value to the overall business. But I would tell you, I'm very pleased with the decisions we've made around driving more promotion, and I'm pleased with the execution of this team. This team has done extremely well.

Oral very very potent and active oral agent in the middle with episodic and then on the backend with Botox, It's a very nice portfolio for us that will drive growth and as Rick mentioned.

We are encouraged on the potential for adjunctive mbd and that segment itself. When we do the market analysis is about as large the adjunctive MDT segment as bipolar depression and so this basically has the opportunity for us to really double the potential penetration over.

Rick Gonzalez: In executing and driving the kind of share of position that we want and the growth. So I think it is sustainable going forward.

Operator: Chris. Operator, next question, please.

Our long range plan. So we're very encouraged over this set of assets and Jeff. This is Robert I would just add if you take the pieces. We've given in terms of long term guidance for railcar, we've talked about approaching $4 billion with the current approved indications.

Operator: Yes, our next question comes from Jeffrey Porges with SVB Lyrinc. Your line is open.

Jeffrey Porges: Thank you very much. I have a couple of questions. First, Rick, something we don't talk about a lot, which is the neuroscience portfolio. You've started reporting it combined. I know there are four products in there, but adding them up, the long-term guidance you provided previously was about $8.3 billion, I think, and you're already annualizing it close to six. So could you give us a sense of how much upside there is

For migraine, both through relevant atone, Japan, we've talked about peak potential of greater than $1 billion for each of those assets and then we have duopoly plus we have 95, one in the pipeline that I think can drive significant growth. In addition to our early stage pipeline neuroscience I do see that as a therapeutic area that will drive long term growth for the company going forward.

Jeffrey Porges: That portfolio has given the trends that you're seeing. And then, sort of on a related question, I hate to harp on the Jack question, but obviously, there's a lot coming to us from what this impact might be. So if you were confined to the 15 milligram dose, not because of any signal, but because of the regulator's just view of the safety of the class, how much impact would that have on the 8 billion long-term guidance? And do you have other levers that you could pull to fill whatever shortfall that would cause?

Great. Thanks, Jack.

Jack.

On the Jack.

We've obviously evaluated carefully.

<unk> of the product I think if we look at where we are today one.

And the Idose.

That is a good risk benefit profile, but I would tell you it wouldn't change our guidance.

Going forward.

The assumptions that we have made in areas like atopic dermatitis.

Believe we can get to those assumptions without the high dose.

Doesn't mean that we don't want to idose, but at the end of the day I believe we can that we will maintain the guidance that we have based on that.

Net.

The other thing that I would point out is that we've had additional data on <unk> or invoke across a number of areas since that guidance, including IBD. So you've had the UC data that have come largely since that guidance and those have exceeded our expectations and so we remain confident overall in the performance of Rainbow.

Rick Gonzalez: On the neuroscience portfolio, it is an area that we're very excited about, so maybe Geoff and I will tag team here, but I think when you look at the two major growth franchises there, the migraine franchise.

Thanks, John.

Thanks, Geoffrey Operator next question please.

Thank you. Our next question comes from Andrew Baum with Citi. Your line is open.

Many thanks, a couple of questions. Please theres not much bipartisan agreements in the USA, but drug price reform, but that seems to be a lot. When it comes to antitrust in relation to the pharmaceutical industry. So perhaps you could comment following last Night's House Committee on the judiciary.

Rick Gonzalez: and the anti-psychotic franchise with Bailoff.

Rick Gonzalez: Both of those, we think, have significant opportunity to continue to grow. I mean, you're obviously seeing Ubrelvi now perform extremely well in the marketplace. I think Geoff can give you probably a little more color on that.

There was lots of.

Rick Gonzalez: And Velar is continuing to perform very well as well. I think if we are able to achieve one positive study on MDD, I think that will give us significant growth going forward. So this is a franchise that we're excited about. I think it will be a meaningful franchise for us over the long term. It's an area where we continue to look at assets that we could potentially add to it.

Pointed talk from both sides, focusing firstly on patent tickets.

On.

Having a presumption that of anti competitive behavior in terms of.

Assessments of large scale in particular M&A.

Meaning it would impact future business development for the industry. So that's the first question and then the second question.

Rather more positive in terms of the Jack when I look at consensus at the full cost per RIN bulk of about $6 billion. When you look at the size of the opportunity and already low less loan psoriatic arthritis, atopic dermatitis, you see it in the other indications you have.

Rick Gonzalez: and I think it'll be a nice growth driver. Geoff?

Geoff Stewart: Yeah, I think just to reiterate, as I mentioned in my comments, the oral CGRP market is moving very nicely. It hit, I mentioned, 16% for the quarter, but now on the weeklies it's 17% or above on just the penetration of that segment, and so we see a lot of runway in that segment over our long-range planning. And to Rick's point, remember, we have the big anchor asset with Botox Therapeutic and Migraine on the back end for chronic migraine.

Is it conceivable to you shortly.

Drug effect could be over Clos being heavily limits it will pull from the market that 6 billion looks like incredibly conservative estimates for what this drug could do.

Andrew This is Rick I'll, obviously comment maybe on your point of view around the antitrust discussions.

Geoff Stewart: And we have plans in place to expand that upstream also into epicenter. This is actually in some ways non-overlapping because we have a big injector base for Botox, and then we can have the neurologist and primary care base for Toja. And so when you look basically across the waterfront, you know, leading acute, oral, very, very potent and active oral agent in the middle with episodic and then on the back end.

Clearly I have accepted the invitation to be able to testify to the committee on May <unk>.

We certainly feel absolutely comfortable and confident in the way we operated in these markets is a highly competitive market.

Where humira competes and certainly as we look at that.

Patents that were issued for Humira. They went through a rigorous process in order to be issued they represent true innovation to the product.

They were challenged by competitors just like every competitor has a right to challenge the patent if they don't believe it's valid or appropriate and those patents were challenged in the vast majority of those patents.

Geoff Stewart: Botox, it's a very nice portfolio for us that will drive sales. And as Rick mentioned, we are, you know, encouraged by the potential for adjunctive MDD. And that segment itself, when we do the market analysis, is about as large as the adjunctive MDD segment as bipolar depression. And so this basically has the opportunity for us to really double the potential penetration over our long-range plan. So we're very encouraged by this set. And Jeff, this is Rob.

Survive that challenge and what I'd say is when we look at our behavior in this market I think our behavior was absolutely pro competitive we have patents to win all the way out to 2034 and that portfolio and yet we chose to license every single Biosimilar player in.

In 2023, literally 11 years before the last patent would have expired.

So I feel highly confident in the position that we have taken in this marketplace that we have operated totally appropriately.

Robert A. Michael: I would just add, if you take the pieces we've given in terms of long-term guidance, for Raylar, we've talked about approaching $4 billion with the current approved indications. For Migraine, both UbrellaVie and AtojoPant, we've talked about peak potential of greater than a billion for each of those assets. And then we have Duopa, plus we have 951 in the pipeline, that I think can drive significant growth, in addition to our early stage pipeline neuroscience. So I do see that as a therapeutic area that will drive long-term growth for the company. Thank you.

And then next question on Rainbow.

<unk>.

Yeah.

I'm, sorry, I was thinking about the first one so can you repeat your question.

I will I mean, you just.

Finishing on the first so you referenced your future.

It was more general rather than just abbvie centric, how it would impact BD.

The EBITDA.

The ability of the industry to operate if pricing comp GAAP results.

Moving on to the second question. So my question was whether consensus forecast.

<unk> written Volk look unrealistically conservative given the scale of the opportunities and given in Iran loans looking at the size of that market. It's a progressive disease that you don't actually need atopic dermatitis to get in excess of where consensus currently peg forecast, which when we look at.

Jeffrey Porges: Great, thanks.

Rick Gonzalez: You're on the jack. We've obviously evaluated it carefully.

Rick Gonzalez: I think if we look at where we are today, one, we're confident in the high dose that has a good risk-benefit profile, but I would tell you, it wouldn't change our guidance going forward. The assumptions that we have made in areas like atopic dermatitis, we believe we can get to those. Without the high dose, that doesn't mean that we don't want the high dose, but at the end of the day, I do. We will maintain the guidance that we have. The other thing that I would point out is that we've had additional data on hepatiocinib or RnVoC across a number of areas since that guidance, including IBD. So we have the UC data that have come out.

<unk> 6 billion.

Andrew This is Robert.

And then I'll hand, it over to Jeff I think we agree with you. We do think consensus conservative we've given that 2025 guidance of 8 billion for <unk> and we would expect it to grow beyond 2025, when I look at the current consensus obviously as you quoted it's a little bit just a little bit above $6 billion for the numbers I'm looking at.

And I look at the growth beyond 25, it's nowhere near what we're expecting so we feel very good about the opportunity. There I think what we've covered with you in December still holds as we've broken out the contribution by indication we still feel very good about that but we would agree that consensus is very conservative right now.

Rick Gonzalez: And those results have exceeded our expectations. And so we remain confident overall in the performance.

Operator: Thanks, Jeffrey. Operator, next question, please.

Yes, Thanks, Robert and as Jeff and agree. It's these are spectacular assets with incredibly dynamic market. So we see across the rheumatology markets. The atopic derm market, we see the IBD market, which with both assets. We think is underappreciated.

Operator: Thank you. Our next question comes from Andrew Baum with Citi. Your line is open.

Andrew Simon Baum: Many thanks. A couple of questions, please. There's not much bipartisan agreement in the U.S. for drug price reform, but there seems to be a lot when it comes to antitrust in relation to the pharmaceutical industry. So perhaps Rick could comment following last night's House Committee on the Judiciary, where there was lots of pointed talk from both sides, focusing firstly on patent thickets, second on having a presumption of anti-competitive behavior in terms of assessments of large scale, in particular M&A, meaning that it would impact future business development for the industry.

Even expansions in second and third lines as new assets come in that are really breakthrough assets with higher levels of efficacy and so we clearly believe that consensus is conservative here and just to comment on atopic Derm. This is this is an explosive market I mean, it is a significantly.

Underdeveloped in terms of in terms of the penetration so it's going to grow substantially and even if you look at conservative assumptions on where we source business. The growth of the second line, that's not to say that we're not going to be very competitive in frontline.

Andrew Simon Baum: So that's the first question. And then the second question, rather more positive, in terms of the JAC, when I look at the consensus, the forecast for RIMBOK is about $6 billion. When you look at the size of the opportunity in RA alone, let alone thoracic arthritis, atopic dermatitis, UCM, and the other indications you have, is it conceivable to you, short of this drug being effective or the class being heavily limited or pulled from the market, that $6 billion looks like an incredibly conservative estimate for what this drug could do?

It's a very very attractive space and again I think the performance that we've seen in the <unk>.

Clinical performance that we've seen right now primarily on the induction trials for <unk> and <unk> in Crohn's, where invoke in UC is very very encouraging and so we see that cascading over our long range plans. It well. So we are very very bullish.

Agree that consensus is conservative.

Many thanks.

Thank you Andrew Operator next question. Please yes.

Yes. Our next question comes from non mill demand with Mizuho Securities. Your line is open.

Okay, great. Thanks, so much for taking my questions a couple if I could on the migraine side. So first on <unk>.

Rick Gonzalez: Andrew, this is this is Rick. I mean, I'll obviously comment.

Rick Gonzalez: Maybe on your point of view around the antitrust discussion. You know, clearly, I've accepted the invitation to be able to testify before the committee on May 18th.

You mentioned it looks like a classic doing very well in <unk>.

And gaining share it helpful. Michael.

Last few weeks or so you've been gaining a little share within the class relative to <unk>.

Rick Gonzalez: You know, we certainly feel absolutely comfortable and confident in the way we operate in this market. This is a highly competitive market where Humira competes. And certainly, as we look at the patents that were issued for Humira, they went through a rigorous process in order to be issued, and they represent true innovation for the product. They were challenged by competitors, just like every competitor has a right to challenge a patent if they don't believe it's valid or appropriate. And those patents were challenged, and the vast majority of those patents were invalidated.

I'm just wondering if you can sort of share your perspective on what you think is driving that some of us thought it might be because of pricing and access but.

On our calculation it looks like your gross to net is actually lower than what James Trump the bio <unk> side. So any perspective would be helpful. And then on the tour, Japan, maybe just a little more if you could talk to your go to market strategy, assuming approval in September, especially again, given our tech will likely have an indication for both treatment and prevention.

Rick Gonzalez: I think our behavior in this market, I think our behavior was absolutely pro-competitiveness. We have patents.

So how do you see.

Coming in with two separate drugs could be to co pays to compete just a difference our message relative to what.

Rick Gonzalez: We went all the way out to 2034 in that portfolio, and yet we chose to...

A single drug so just any perspective on how you will continue.

Would that would be helpful as well.

Rick Gonzalez: [inaudible]

Yeah.

Yeah, Okay, perfect, it's Jeff and and in terms of the acute market as I mentioned the penetration of the overall segment is increasing very very nicely as I highlighted if you look at the mix between.

Rick Gonzalez: I feel highly confident in the position that we have taken in this marketplace and that we have operated totally appropriately.

Rick Gonzalez: And then your next question on Winvoke.

Rick Gonzalez: I'm sorry, I was thinking about the first one, so can you repeat your question? I will.

<unk> and <unk>.

We have gained a little bit over the last few weeks, but its very close I mean, we typically run at $51 50, 253% of the new prescription basis. I think you are quite perceptive over the value creation, that's taking place there and I clearly don't have.

Andrew Simon Baum: I will. I mean, just finishing on the first, so you can reference your future testimony.

Andrew Simon Baum: I guess it was more general rather than just AbbVie-centric, how it would impact BD and the ability of the industry to operate if pricing couldn't get resolved. But moving on to the second question. So my question was whether consensus forecasts for RIMVOC look unrealistically conservative, given the scale of the opportunities and given that RA alone, looking at the size of that market, it's a progressive disease, that you don't actually need atopic dermatitis to get in excess of where consensus currently pegs forecasts, which are, when we look, about $6 billion. Andrew, this is Rob.

Full insight into the bio Haven, all through but we've been quite disciplined we have over 90% commercial access. So we're quite comfortable where we are from an overall access perspective, and our team remains quite disciplined in terms of making sure that we both drive the right type of volume with our positioning.

But also the right type of profitability over time. So we're encouraged with our continued momentum with <unk> in terms of a toll Japan I think what <unk>.

Robert A. Michael: I'll start and then I'll hand it over to Geoff. I think we agree with you. We do think consensus is conservative. We've given 2025 guidance of $8 billion for RINVOKE, and we would expect it to grow beyond 2025. When I look at the current consensus, obviously, as you quoted, it's a little bit just a little bit above $6 billion for the numbers I'm looking at. And when I look at the growth beyond 25, it's nowhere near what we're expecting.

Quite impressive about our program. There is just the sheer level of efficacy that we have and I think this is very important in terms of sometimes the narrative over simple or easy versus look how do you think about the best drug for episodic prevention, particularly when you choose an oral so we are at the very very high end of the.

Migraine freedom or the days of migraine control with this new asset and we think that frankly, you need to take care of the migraine and <unk> will be very well positioned to do that we also think that we'll have nice synergies. Obviously, we have a fairly significant sales force that is promoting <unk> to both.

Robert A. Michael: So we feel very good about the opportunity there. I think what we covered with you in December still holds. As we've broken out the contribution by indication, we still feel very good about that. But we would agree that consensus is very conservative right now.

<unk> and high prescribing general practitioners and it will fit in very well as we put a toe Japan into that sales suites. So we're set up well we think for our go to market.

Okay. Thank you very much.

Geoff Stewart: Yeah, thanks, Rob and Geoff, and I agree that these are spectacular assets with incredibly dynamic markets. So we see across the rheumatology markets, the atopic derm market, we see the IBD market, which, with both assets, we think is underappreciated, and even expansions in second and third lines as new assets come in that are really breakthrough assets with higher levels of efficacy. And so we clearly believe that consensus is

Thanks, Rommel operator next question please.

Our next question comes from Tim Anderson with Wolfe Research Your line is open.

Thank you a couple of questions for you I Havent heard any drug company.

This reporting season talk about future potential austerity measures and ex U S geographies, meaning broad based price cuts.

Following from the impact of COVID-19. So as a company that was one of the few companies as Kevin detailed long term financial guidance I'm guessing you have been thinking about this and I'm wondering how you are currently viewing this in terms of its likelihood.

Geoff Stewart: And just to comment on Atopic Derm, this is an explosive market. I mean, it is significantly underdeveloped in terms of penetration, though it's going to grow substantially. And even if you look at conservative assumptions on where we source business, you know, the growth of the second line, that's not to say that we're not going to be very competitive in frontline. It's a very, very attractive market. Again, I think the performance that we've seen, the clinical performance that we've seen right now, primarily in the induction trials for SCIRIZI and RINVOC, SCIRIZI and CRONES, RINVOC and UC, is very, very encouraging, and so we see that cascading over our We are very, very bullish.

Occurring and what the magnitude could be and what the timing might be and then second question just on our early stage pipeline asset your TNF steroid antibody drug conjugate I believe you have in house, probably a fair amount of data that the markets havent seen yet.

I'm wondering when we might see additional human data and what your current level of enthusiasm is towards that platform.

So Tim this is Rick I'll cover the U S. Austerity measures I mean, certainly if we go back to 2008.

We saw that kind of an impact so as we're building out our long range plan. We have made some sets of assumptions around that I would expect that we will see some pressure.

Did the U S going forward.

Over the next couple of years, it's certainly manageable within the within the expectations that we have built for the business going forward.

Certainly based on that level of experience that we've seen historically.

Manageable so.

Operator: Thank you, Andrew. Operator, next question, please.

It is something that we've contemplated and.

Frankly, we expect to see some level of pressure going forward.

Operator: Yes, our next question comes from Vamil Divan with Vizio Securities. Your line is open.

So this is Mike I'll take the second question with respect to the TNF steroid conjugate program.

Vamil Kishore Divan: Great. Thanks so much for taking my questions. Maybe a couple if I could on the migraine side.

<unk>, obviously advancing ABV one four we have a large phase <unk> study that will start this quarter and then we are starting studies in additional immune mediated conditions as well over the course of the year with respect to publication of the of the data from three $3 73, which is the closely.

Vamil Kishore Divan: So first, on your Brelby, you mentioned that the class is doing very well in gaining share. It also looks like, over the last few weeks or so, you've been gaining a little share within the classroom relative to NeurTech. So I'm just wondering if you can sort of share your perspective on what you think is driving that. Some of us thought it might be due to pricing and access, but based on our calculations, it looks like your gross to net is actually lower than what it is on the BioAven side.

Related to.

Compound from the same platform that we our topline results. Some time ago. I think you can expect to see more detailed data over the course of the summer.

Thanks, Tim Operator next question please.

Vamil Kishore Divan: So any perspective would be helpful. And then on Total Japan, maybe just a little more if you could talk about your kind of go-to-market strategy, assuming approval in September, especially again, given NeurTech will likely have an indication for both treatment and prevention. So how do you see, you know, kind of coming in with two separate drugs? It could be two copays, it could be just a different message relative to what, you know, a single drug. So just any perspective on how you'll compete with that would be helpful as well. Thank you.

Thank you. Our next question comes from Steve Scala with Cowen Your line is open.

Many thanks first on <unk> I'm curious what additional safety data has FDA been provided that it did not have previously and has all of it been previously presented and if not what was the conclusion of what now has been submitted so that's the first question and secondly regarding <unk>.

To what extent can abbvie.

He's out COVID-19 impact on new patient starts versus competition from new frontline agents.

So this is Mike I'll take the first question and then Rick will handle the second with respect to <unk>. The additional safety data that were presented to the FDA or provided to the FDA or essentially a roll forward of the analysis that.

Geoff Stewart: Okay, perfect. It's Geoff.

Geoff Stewart: And in terms of the acute market, as I mentioned, the penetration of the overall segment is increasing very, very nicely, as I highlighted. If you look at the mix between Ubrelvi and NERTEC, we have gained a little bit over the last few weeks, but it's very close. I mean, we typically run at 51, 52, 53 percent of the new prescription base. I think you are quite perceptive about the value creation that's taking place there, and I clearly don't have full insight into the BioHaven fall through, but we've been quite disciplined.

Debt, we did at the time of the NDA submission obviously, our database continues to grow we accumulate patient years experienced and so there werent.

Fundamentally new analysis, but we did an updated assessment with the additional data that have accrued in the time between submission and when we submitted those responses and what I would say is the data that we reviewed have not changed our impression of benefit risk.

Anyway, I think theyre very consistent with all of the data that have been publicly presented obviously since they represent data that we're current up to the time that we submitted just a few weeks ago not all of these data.

Geoff Stewart: You know, we have over 90% commercial access, so we're quite comfortable where we are from an overall access perspective, and our team remains quite disciplined in terms of making sure that we both drive the right type of volume with our positioning, but also with Hugh Brelby. In terms of Etojopant, I think what's quite impressive about our program there is just the sheer level of efficacy that we have. And I think this is very important in terms of sometimes the narrative over simple or easy versus, look, what do you think about the best drug for episodic prevention, particularly when you choose an oral drug?

Have been presented in the public domain, but I would say that our response is very consistent with what we have described publicly in the past.

On your second question this is Rick.

We get data on new patient starts. So we have relatively I think accurate data. It is offset by a couple of months I'll have Jeff maybe talk about a little more detail. So we know any CLO patients when they start regardless of therapy, we can measure that and obviously, we can measure again, what type of therapy. They start on so.

I think the level of data integrity that we operate with.

From a market standpoint here is pretty good it's offset by a few months, maybe Jeff can speak to the time offset them.

Geoff Stewart: So we are at the very, very high end of migraine freedom or the days of migraine control with this new asset. And we think that, frankly, you need to take care of the migraine, and Etojopant will be very well positioned to do that. We also think that we'll have nice synergies. Obviously, we have a fairly significant sales force that is promoting Ubrelvi to both neurologists and high prescribing general practitioners. And it will fit in very well as we put ToeJapan into that sales sleeve. So we're set up well, we think, for our go-to-market.

Yes, Steve it's Jeff. So we can we have pretty good visibility to what what's happening from a share perspective versus the market start perspective, I'll give you some flavor with regard to <unk>. We can we can see the impact of the approvals in the front and second line <unk> and its largely consist.

<unk> with what our expectations were so theyre ramping in a similar fashion to what we saw in the mcl or NHL. So we know that there is some impact on and improve it to there the largest impact has been unfortunately into the market and unfortunately, I mean for the patient. So I'll give you a little bit of the numbers. So typically the CLO market, which is the.

Geoff Stewart: Okay, thank you very much.

Operator: Thanks, Vamil. Operator, next question, please.

Operator: Our next question comes from Tim Anderson with Wolf Research. Your line is open.

Timothy Minton Anderson: I haven't heard any drug company this reporting season talk about future potential austerity measures in ex-U.S. geographies, meaning, you know, broad-based price cuts following from the impact of COVID. So as a company, as one of the few companies that've given detailed long-term financial guidance, I'm guessing you have been thinking about this, and I'm wondering how you would respond to that.

The largest driver it grows sort of at a population level like 2% every year. If you look at the impact from COVID-19, we can see almost three different ways. We can see a wave where the new patient starts in the market were down in the high teens in the first part. Okay. Then it started to claw back a little bit into the single digits.

Down and then it got hit again into the into the teens in the August period, and we saw it down again in early January about 18%. So we can see what's happening and as I mentioned in my remark remarks. The biggest the biggest impact here has been on continued market suppression due to COVID-19 and Steve.

Timothy Minton Anderson: You are currently viewing this in terms of its likelihood. [inaudible]

Unknown Speaker: So, Tim, this is Rick. I'll cover the OUS austerity measures. I mean, certainly if we go back to

As Rob I would just remind you also in the first quarter that we had the stocking impact from COVID-19 last year. So if you adjust for that it's about a four point impact on <unk> growth year over year due to the prior year comp with the stocking impact.

Rick Gonzalez: Without our long-range plan, we have made some sets of assumptions around that.

Unknown Speaker: [inaudible]

Mike Severino: So, this is Mike. I'll take the second question.

Thank you.

Thanks, Steve Operator next question please.

Yes. Thank you.

Our next question comes from David Risinger with Morgan Stanley. Your line is open.

Mike Severino: With respect to the TNF steroid conjugate program, we're obviously advancing ABVV154. We have a large Phase IIb RA study that will start this quarter, and then we're starting studies in additional immune-mediated conditions as well over the course of the year. With respect to publication of the data from 3373, which is the closely related compound from the same platform that we received top-line results some time ago, I think you can expect to see more detailed data over the course of the summer.

Yes, thanks, very much and congrats on the results and updates I have two questions first just to follow on on that comment.

Could you just help us understand a little bit more about why <unk> is such an outlier in the cancer market why the pandemic is hitting in brewbaker very hard whereas the.

The pandemic is not hitting other cancer agents, so hard and then second.

Operator: Thanks, Tim. Operator, next question, please.

With respect to athletics, its obviously booming and.

Operator: Thank you. Our next question comes from Steve Scala with Cohen. Your line is open.

It is validating your acquisition of Allergan.

Steve Scala: Many thanks. First, on RINVOKE, I'm curious what additional safety data has FDA been provided that it did not have previously? And has all of it been previously presented? And if not, what was the conclusion of what has now been submitted?

But I think that you updated guidance for the year for Botox cosmetic to $1 9 billion and that implies flat.

Flat sequential sales from the 477 million net you booked in the first quarter. So if you could explain that please thank you.

Steve Scala: So that's the first question. And secondly, regarding Imbruvica, to what extent can AbbVie tease out COVID's impact on new patient starts versus competition from new frontline agents? Thank you. This is Mike. I'll take the first question, and then Rick will handle the second.

Yeah.

So this is Mike I'll take the first question and then others will comment on your second question with respect to improve our cash is being hit harder.

Mike Severino: With respect to RINVO, the additional safety data that were presented to the FDA, or provided to the FDA, are essentially a roll forward of the analysis that we did at the time of the NDA submission. Obviously, our database continues to grow, we accumulate patient years of experience, and so there weren't...

Then other anticancer agents in the pandemic I think it has to do with the underlying rate of progression of CLO.

While it is.

A very significant limiter of long term function and survival in the short term there is a sense that therapy can be delayed if necessary because the rate of progression is relatively slower than other forms of cancer. For example, certainly much slower than AML. Another indication that we are very active in.

Mike Severino: Fundamentally new analyses, but we did an updated assessment with the additional data that have accrued in the time between submission and when we submitted it, and what I would say is the data that we reviewed have not changed our impression of benefit-risk in any way. I think they're very consistent with all of the data that have been publicly presented. Obviously, since they represent data that were current up to the time that we submitted just a few weeks ago, not all of these data have been presented in the public domain, but I would say that our response is very consistent with what we have described.

In the in the Haemonchus space and so I think in the in the setting of the pandemic. That's why you are seeing more deferrals for startup therapy.

And in some cases longer time to switch of therapy, which would explain why in <unk>.

The dynamics are different than other anti cancer agents to treat other diseases.

And David This is Rob on your question regarding Botox cosmetic. So we did see in the first quarter. If you just look at toxins market growth, it's over 30% in the first quarter. There is some impact from pent up demand as we come out of the pandemic, but we feel very good about the long the forecast we put forward. We obviously took it up a 100 million so essentially pass through the beat in the quarter.

Rick Gonzalez: On your second question, this is Rick. We get data on new patient starts, so we have relatively

Rick Gonzalez: I think the accurate data is offset by a couple of months.

Rick Gonzalez: I'll have Geoff maybe talk about it in a little more detail, so we can understand any CLL patient.

I would say your math on flat sequentially I think it's up a little bit, but really if you consider that we did have some level of pent up demand coming through in the quarter you got to back that out to really understand the underlying demand dynamics.

Rick Gonzalez: C.L.L. patient, when they start, regardless of therapy, we can measure that, and obviously, we can measure, again, what type of therapy they start on. So I think the level of data integrity that we operate with from a market standpoint is pretty good. It's all set by a few months. Maybe Jeff. I'm offset. Yeah, so Steve, it's Jeff.

Thank you Steve.

Thanks, David Operator next question please.

Your next question comes from Ronny Gal with Bernstein. Your line is open.

Hi, everybody congratulations on a very nice quarter and thank you for fitting me in two.

Two questions if I may.

There was some data presented from Brexit or about negative symptom improvement using <unk> I was wondering what is your take on the data in terms of your ability to use it in the United States is it something that you're considering doing a trial on could this potentially be added to the label and so forth.

Geoff Stewart: So we can we have pretty good visibility into what's happening from the share perspective versus the market start perspective. I'll give you some flavor with regard to CalQuint. You know, we can see the impact of the approvals in the front and second line CLL, and it's largely consistent with what our expectations were. So they're ramping in a similar fashion to what we saw in the MCL or NHL.

And second the growth in Botox neurology is really impressive.

Seems relatively odd that there was such a big jump in the middle of it.

A wave of the epidemic in January February for a physician administered product could you just give us a flavor of what the underlying trends. There. They are just a lot more success that you're having in pushing price patients who failed at Citi European too into Botox, how should we think about this.

Geoff Stewart: So we know that there's some impact on Imbruvica there, but the largest impact has been, unfortunately, on the market. And unfortunately, I mean, for the patient.

So this is Mike I'll take the first question and then others can comment on your second question with respect to negative symptoms and the treatment of those negative symptoms in schizophrenia. Its a very challenging area. It's very important area because they are responsible for much of.

Geoff Stewart: So I'll give you a little bit of the numbers. So typically, the CLL market, which is the largest driver, grows sort of at a population level, like 2% every year. If you look at the impact of COVID, we can see almost three different ways; we can see a wave where a new patient starts on the market; we're down in the high teens in the first part, okay, then it started to claw back a little bit into the single digits.

The long term loss of function in patients who suffer from schizophrenia. It has been a very difficult area to approach in general and we believe <unk> has a good profile there and has a good overall impact on the disease, a very strong overall impact on the disease, but it's also one that's been very challenging from a labeling perspective in the U S. It's been a very difficult.

Claim to get in the U S. So it's not clear that there is a specific path to negative symptoms.

In the label, but I do think the overall profile of <unk> in schizophrenia, both with respect to symptom control and benefit risk are viewed.

Geoff Stewart: And then it got hit again into the into the teens in the August period. And we saw it down again in early January, about 18%. So we can see what's happening. And as I mentioned in my remark, remarks, the biggest the biggest impact here has been on continued market suppression. And Steve, this is Rob. I would just remind you also in the first quarter that we had the stocking impact from COVID last year. So if you if you adjust for that, it's about a four point impact on Imbruvica's growth year over year due to the prior year comp with the stocking impact. Thank

Very positively by treating physicians and I think the overall benefits are well understood by treating physicians and I think that.

As reflected in <unk> overall strong performance.

And it's Jeff in regard to Botox, it's insightful because we are seeing some robust activity, particularly in migraine.

And I think Theres, a couple of reasons for that.

One Rick highlighted the sales force dynamics in China, we've definitely focused our sales team.

On the on the migraine.

Robert A. Michael: Thanks, Steve. Operator, next question, please. Yes, thank you.

Component and the other thing Thats taken place is a little bit I think of an investment approach, we have more consistent consumer investment.

Operator: Our next question comes from David Risinger with Morgan Stanley. Your line is open.

We had the integration than previously the legacy Allergan. So I think the combination of the consumer investment new ways, where if patients access <unk> injector neurologists. They can get a sample of botox right at their first first appointment rather than wait for many months there are various commercial.

David Risinger: Yes, thanks very much. And congrats on the results and updates. I have two questions. First, just to follow on from that comment. Could you just help us understand a little bit more about why Imbruvica is such an outlier in the cancer market? Why is the pandemic hitting Imbruvica very hard, whereas the pandemic is not hitting other cancer agents so hard? And second, with respect to aesthetics, it's obviously booming.

Shall reasons, we think that gives us a lot of encouragement on the therapeutic botox performance again, specifically and particularly in migraine.

Thank you.

Thanks, Ronny operator next question please.

Our next question comes from Terence Flynn with Goldman Sachs. Your line is open.

David Risinger: And it is validating your acquisition of Allergan. But I think that you updated guidance for the year for Botox cosmetics to 1.9 billion. And that implies Thank you. This is Mike.

Great. Thanks for taking the question maybe two for me I recognize there is still a lot of unknowns here, but how are you thinking about the potential headwind from any changes to corporate tax rates and guilty.

Mike Severino: I'll take the first question and then others will comment on your second question. With respect to why Imbruvica is being hit harder than other anti-cancer agents in the pandemic, I think it has to do with the underlying rate of progression of CLA. So CLL, while it is... a very significant limiter of long-term function and survival. In the short term, there's a sense that therapy can be delayed if necessary because the rate of progression is relatively slower than other forms of therapy.

And then given the progress you outlined on debt Paydown.

You'll be back to you about a two times leverage ratio you mentioned how.

How are you thinking about capital allocation into the end of this year and into 2022, what types of assets are you focused on for BD and M&A. Thank you.

So this is Rick I'll cover the tax I mean, as you said, it's certainly early in the process and we obviously know what's being proposed but we don't necessarily know where we will end up I think one of the important things that.

Mike Severino: And so I think in the setting of the pandemic, that's why you are seeing more deferrals for start-up therapy and, in some cases, longer time to switch off therapy, which would explain why Bruvica dynamics are different than other anti-cancer agents that treat other, David, this is Rob. On your question regarding Botox Cosmetic.

<unk>.

We need to continue to think through.

If we go back to one of the reasons why back in 2017 tax reform was passed it was to make sure that two things happen one that U S. Based companies were competitive with our foreign competitors and to encourage companies like ours to invest in the United States.

Robert A. Michael: So we did see in the first quarter, if you just look at the toxins market growth, it's over 30% in the first quarter; there is some impact from pent-up demand as you come out of the pandemic. But we feel very good about the long-term forecast we put forward, and we obviously took it up by 100 million to essentially pass through the beat in the quarter. I'd say your math on flat sequential is up a little bit. But really, if you consider that we did have some level of pent-up demand come through in the quarter, you have to back that out to really understand the underlying demand dynamics.

Can certainly talk about the Abbvie example.

It's pretty compelling when you sit back and look at we were able to go out and acquire an Irish company re domicile of back to the United States Abbvie.

Abbvie today is 24000 jobs in the United States.

We've also increased investments significantly in the U S since tax reform.

Over the last three years, we've invested.

1 billion $5, we committed that we would do two $5 billion over time revenue exceed that commitment.

We've added about 500 jobs over that period of time, so companies like ours, clearly took the benefit of tax reform and that has allowed us to be able to be more competitive.

Operator: Thanks, David. Operator, next question, please.

Certainly in the acquisition of a company like Allergan I think that was clearly demonstrated but we also have invested much more aggressively in the U S. So I think going forward one of the things that's important.

Operator: Yes, our next question comes from Ronnie Gao with Bernstein. Your line is open.

Ronnie Gao: Hi everybody, congratulations on a very nice quarter and thank you for fitting me in. Two questions, if I may. First, there was data presented from Richter about negative symptoms.

For policymakers to balance is to make sure that we don't go back to where we were and that is where U S companies aren't as competitive against their foreign competitors. The current proposal would make.

U S had the highest rate of all developed countries I'm not sure that's the position you'd want to be in so hopefully as we go forward there'll be a balance that's looked at.

Ronnie Gao: I was wondering what your take on the data in terms of your ability to use it in the United States? Is it something that you're considering doing a trial on? Could this potentially be added to the label, and so forth? And second, the growth in VODOC's neurology is really impressive.

And raising taxes, but also making companies maintain and competitive position.

And continue to be incentive to invest in the U S.

Eric This is Robin your question regarding capital allocation I'll start then Michael add more color in terms of BD.

We've said all along is we continue we will continue to delever through 2023, so think about debt net leverage ratio getting to two times in 2002 and your balance sheet have been very good shape, but we want to continue to pay down the debt through 'twenty three during that period, we have allocated $2 billion of capital for business development, you've seen us do some very nice deals whether it's you look at Genmab.

Ronnie Gao: It seems relatively odd that there was such a big jump in the middle of a wave of

Ronnie Gao: A Wave of the Epidemic in January and February for a Physician-Administered Product. Can you just give us a flavor of what the underlining trends there are? There's just a lot more success that you're having in pushing patients who failed at C-GRP into Botox. What should we think about

Mike Severino: This is Mike. I'll take the first question, and then others will comment on your second question. With respect to negative symptoms and the treatment of those negative symptoms in schizophrenia, it's a very challenging area. It's a very important area because they're responsible for much of the long-term loss of function in patients who suffer from schizophrenia. It has been a very difficult area to approach in general, and we believe Braylor has a good profile there and has a good overall impact on the disease, a very strong overall impact on the disease.

Average number of nice transactions in this space with that amount of capital, but I'll, let Mike speak to future opportunities as well.

In terms of the areas in which we would expect to be active between now and the end of 2022, we will continue to be active in oncology both in Hematological oncology and in solid tumors that has been an area of focus for us and I see that continuing as an area of focus we would certainly like to add to the.

Aesthetics franchise, we've talked about how we will invest and continue to drive that franchise and from a business development perspective, I think there are a number of opportunities there that could present themselves in that timeframe and there are other areas that opportunistically, we would certainly like to add too I would point to neuroscience, if we could find the right opportunity.

Mike Severino: But it's also one that's been very challenging from a labeling perspective in the U.S. It's been a very difficult claim to get across in the U.S. So it's not clear that there is a specific path to negative symptoms in the label, but I do think the overall profile of Braylor in schizophrenia, both with respect to symptom control and benefit-risk, is viewed very positively by treating physicians, and I think the overall benefits are well understood by treating physicians, and I think that is reflected in Braylor's overall strength.

<unk>.

Eyecare as additional areas, where we could be investing.

Thanks, Terence operator next question please.

Our next question comes from Daniel <unk> with RBC capital markets. Your line is open.

Hi, good morning, I'd like to ask a follow up on aesthetics and your high single digit annual growth target for that business over the next decade broadly speaking how much of that growth is dependent on bringing new products to market such as long and short acting toxins versus driving continued growth from the aesthetics portfolio that you have today.

Geoff Stewart: And it's Jeff. Regarding Botox, it's insightful because we are seeing some robust activity, particularly in migraine, and I think there are a couple reasons for that. You know, one, Rick highlighted the Salesforce dynamics in China. We've definitely focused our sales team, you know, on the migraine component. And the other thing that's taken place is a little bit, I think, of an investment approach. We've had more consistent consumer investment. Since we had the integration then previously, the Legacy Allergan.

And second as we near the one year anniversary of your acquisition of Allergan can you provide updated thoughts on your appetite for potential divestitures of noncore products or therapeutic areas now that you've had about a year to digest that transaction. Thank you.

This is Rick I'll cover that and maybe.

Can.

Can tag team on here I think if you look at our overall estimate of high single digit growth on a steady it's not heavily reliant on a large number of new products, there will be new products that come in they are probably closer towards the back end of the long range plan.

Geoff Stewart: So I think the combination of consumer investment and new ways where if patients access an injector or neurologist, they can get a sample of Botox right at their first appointment rather than wait for many months. There are various commercial reasons we think that give us a lot of encouragement about the therapeutic performance of Botox, again, specifically and particularly in migraine.

So they don't have they don't have a significant impact on that overall growth rate. So I think we fundamentally believe that the market dynamics are such and the brands are our competitive.

Highly competitive in this market that we have the ability to grow the market and continue to maintain our share position in that market and that will allow us to be able to drive that level of growth or higher.

Operator: Thanks, Ronnie. Operator, next question, please.

Operator: Yes, our next question comes from Terence Flynn with Goldman Sachs. Your line is open.

Yes. This is Robert I'll, just add that if you look at the aesthetics business and we will see significant growth not just from toxins and fillers, but also in body contouring. So as we think about.

Terence Flynn: Great. Thanks for taking the question. Maybe two for me.

Terence Flynn: I recognize there's still a lot of unknowns here, but how are you thinking about the potential headwinds for many changes to corporate tax rates and GILTI? And then, given the progress you outlined on debt paydown, you'll be back to about a two times leverage ratio you mentioned. How are you thinking about capital allocation into the end of this year and into 2022? What types of assets are you focused on for BD and M&A? Thank you. So this is Rick. I'll cover the tax.

The potential for that leg of the stool. We think we've got really three key drivers of growth within within aesthetics that will help us get to that high single digit.

Our long term expectation and again as Rick mentioned, we are not counting on significant contribution from the pipeline. Although we will continue to drive innovation, particularly with toxins and fillers and of course.

As you've heard before it's important within body contouring to continue to drive innovation, there as well. So we feel very good about that outlook and we're not counting on a ton from the pipeline there.

And then your second question I would say even before the Allergan acquisition, we constantly looked at our portfolio and determine whether or not there were areas of our business that we ultimately thought we were interested in divesting I'd say, that's a process that we go through.

Rick Gonzalez: You said it's certainly early in the process, and we obviously know what's being proposed, but we don't necessarily know where we will end up. I think one of the important things that we need to continue to think through is if we go back to one of the reasons why, in 2017, tax reform was passed, to make sure that two things happen. One, that U.S.-based companies were competitive with their foreign competitors, and two, it encouraged companies like ours to invest in the United States.

On a fairly consistent basis to ensure that we're maximizing the value of the assets that we have within our portfolio and so.

We will continue to do that and when we find opportunities where we think.

That's the right strategy, and we will execute against that strategy.

Thanks, Daniel Operator next question please.

Our next question comes from Gary Nachman with BMO capital markets. Your line is open.

Thanks.

More from me on Rainbow.

Are you hearing anecdotally any physicians that may be switching patients from Belgium to invoke NRA. If there is a perceived safety benefit with <unk> as a more selective JAK are you able to take advantage of that at all.

Rick Gonzalez: I can certainly talk about the AbbVie exam. I mean, I think it's pretty compelling when you sit back and look at how we were able to go out and acquire an Irish company and re-domicile it back to the United States. You know, AbbVie today has 24,000 jobs in the United States. We've also increased investment significantly in the U.S. For the last three years, we've, (inaudible) I think that was clearly demonstrated, but we also have invested much more aggressively in the U.S.

And then secondly, if <unk> gets approved for atopic Derm, how will you look to build out your presence with dermatologists. When you leverage your current footprint on the aesthetic side or whether you have a completely different medical derm team.

Just talk about how you go after that opportunity and how you are preparing for it given your clear level of excitement there. Thank you.

Yes, Hi, it's Jeff and I'll take both of those so we are we're actually not hearing physicians.

Rick Gonzalez: So I think going forward, one of the things that's important for policymakers to balance is to make sure that we don't go back to where we were, and that is where U.S. companies aren't as competitive against their foreign counterparts. The current proposal would make the U.S. have the highest rate of all developed countries. I'm not sure that's the position.

From our intelligence from our field teams actively.

Thinking to switch patients from Xeljanz to <unk> I mean, that's a big decision for a physician.

We have heard is when we do some are of our research and our ear to the ground, we clearly see that or oral surveillance is perceived as a xeljanz issue. So typically what will happen is you may see people take their foot off the gas on some new starts.

Unknown Speaker: want to be in. So hopefully, as we go

Unknown Speaker: There'll be a balance that's looked at.

Rick Gonzalez: In raising taxes but also making companies maintain a competitive position.

But we don't we don't see or hear.

Rick Gonzalez: and continue to be incented to invest in

Certainly any widespread news of active switching so thats basically our intelligence on your first question.

Rick Gonzalez: to invest in the U.S.

Robert A. Michael: Terence, this is Robin. Your question regarding CEPA allocation. I'll start, and then Mike will add more color in terms of BD. We've said all along that as we continue, we will continue to delever through 2023. So, you know, think about that net leverage ratio getting to two times in 2022. I think our balance sheet would be in very good shape, but we want to continue to pay down the debt through 2023. During that period, we've allocated $2 billion of capital for business development.

In terms of your second question.

We will not be using the aesthetic sales force, we will basically leverage our existing infrastructure that we have with some expansion that we've taken place for <unk> in atopic dermatitis I think as you know that in terms of our our reputation amongst the medical derm is extremely strong.

We have the number one reputation because of the years of Humira in psoriasis and Psoriatic arthritis in Hs and obviously, we have a very very strong impression and launch from sky risky. So we basically designed a sales force that through our management, which has been connected to these terms for more than <unk>.

Mike Severino: You've seen us do some very nice deals, whether you look at GenMap or IMAP, we've done a number of nice transactions in the space with that amount of capital, but I'll let Mike speak about future opportunities. In terms of areas in which we would expect to be active between now and the end of 2022, we'll continue to be active in oncology, both in hematological oncology and in solitubers. That has been an area of focus for us, and I see that continuing to be an area of focus.

A decade and existing reps with some new reps in there. We are building we have built a sales force that will work seamlessly with our sky rizzi teams to give a very nice offering to those dermatologists and important fact is that basically the overlap of those dermatologists that drive basic.

The atopic derm market is about 90% between the atopic derm market in the psoriasis market. So we feel we're well positioned in terms of how we set up our go to market approach with this segment.

Mike Severino: We would certainly like to add to the aesthetics franchise. We've talked about how we will invest in and continue to drive that franchise, and from a business development perspective, I think there are a number of opportunities there that could present themselves in that timeframe. And there are other areas that, opportunistically, we would certainly like to add to. I would point to neuroscience, if we could find the right opportunities, and eye care as additional areas where we could do that.

Thanks, Gary Operator next question. Please yes.

Yes. Our next question comes from Gregg Gilbert with true with Securities. Your line is open.

Thank you Michael I was interested in your oral psoriasis commentary are you assuming that a new bar has been set baidu kravis sitting up in terms of efficacy versus low Tesla.

Net something we're very mindful of as you consider your own programs and secondly for Rick.

Operator: Thanks, Terence. Operator, next question, please. Yes.

I realised abbvie was born out of a company that had devices and pharma under one roof, but clearly you've embraced it.

Operator: Yes, our next question comes from Daniel Busby with RBC Capital Markets. Your line is open.

Fedex for example.

Good franchise building could involve drugs and devices or.

Drugs that need to be delivered by device does that apply as you think ahead about ophthalmology or other areas. When you consider long term BD. Thank you.

Daniel Busby: Good morning. I'd like to follow-up on aesthetics and your high single-digit annual growth target for that business over the next decade. Broadly speaking, how much of that growth is dependent on bringing new products to market, such as long and short-acting toxins, versus driving continued growth from the aesthetics portfolio that you have today? And second, as we near the one-year anniversary of your acquisition of Allergan, can you provide updated thoughts on your appetite for potential divestitures of non-core products or therapeutic areas now that you've had about a year to digest that transaction? Thank you. This is Rick.

So this is Mike I'll take the first question with respect to oral psoriasis agents, we would want to come in from an efficacy perspective with something that clearly exceeded the threshold that existed in the past without Tesla and I think coming in.

In a in a range that is humira like were better.

Would be our goal I think if you look at.

BMS is TIK two they sort of come in at that Humira like efficacy and so I think that is generally the range that we're talking about I think when when one talks about a direct comparison in terms of where the bar is set we have to look not only at efficacy, but its safety and its the totality of the data obviously is extremely early for for our <unk>.

Rick Gonzalez: I'll cover that and maybe... Tag team along here.

Unknown Executive: I think if you look at our old house,

Unknown Executive: Unknown Executive, Mohit Bansal, Carson Wong, Perry Siatis, Marcella Pinella, AbbVie Unknown Executive, Mohit Bansal, Carson Wong, Perry Siatis, Marcella Pinella, AbbVie Yeah, this is Rob. I would just add that if you look at the aesthetics business, we'll see significant growth, not just from toxins and fillers but also in body contouring So as we think about the potential for that leg of the stool, you know, we think we've got really three key drivers of growth within aesthetics that will help us get to that high single-digit long-term expectation.

Again, the T agent, but we think it is a molecule.

Does it impact is very well understood biology with with a good understanding of where to go from an efficacy perspective and a good understanding of safety that we can get in a range thats very competitive there. So I think we'd be looking for that humira like efficacy.

Or greater as something that we would like to use to enter this space with an oral obviously, coupled with with a strong safety profile.

So your second question. This is Rick I mean, I think the way we approach the markets that we operate in and as we look for areas, where there are significant unmet need and then we ultimately try to come up with solutions for those needs. Sometimes it's drug only embeds I'd say the majority of our historical experience as Abbvie has been able to draw the only.

Unknown Executive: And again, as Rick mentioned, we're not counting on significant contribution from the pipeline, although we will continue to drive innovation, particularly with toxins and fillers. And of course, as you've heard before, it's important within body contouring to continue to drive innovation there as well. So we feel very good about that outlook, and we're not counting on a ton from the pipeline. And then your second question, I would say, you know, even before the Allergan acquisition, we constantly looked at our portfolio and determined whether or not there were areas of our business that we ultimately thought we were interested in divesting.

But as an example, 95 one is a good example of where it's a combination product <unk> device and as Rod certainly as we look at ophthalmology, we have implantable devices.

They were part of the Allergan acquisition that are important therapeutic options that are available for physicians and patients.

So I'd say, we tend to go at it and we're certainly not opposed to.

Two devices being part of it if they can add to the ability to be able to provide for an advancement in the standard of care in aesthetics as Rob indicated a moment ago. We're looking at what is that big third leg on the stool and we believe that his body.

And I would say in the area of body devices are going to play a much more critical role and so that's an area, where I think youll see us embrace.

Unknown Executive: I'd say that's a process that we go through on a fairly consistent basis to ensure that we're maximizing the value of the assets that we have within our portfolio. And so, you know, we will continue to do that. And when we find opportunities where we think that's the right strategy, then we'll execute against that.

Even device only kinds of strategies because they provide the right solution for that particular.

That particular improvement so it's an area that we historically many of us know well because of our experience as you pointed out.

In our previous life, but I would say also the teams in the organization itself tend to look for broad based solutions that can meet the unmet need.

Robert A. Michael: and we'll execute against that strategy.

Thank you.

Thanks, Gregg operator, we have time for one final question.

Unknown Speaker: Thanks, Daniel. Operator, next question, please. Yes.

Thank you our last question comes from Navin Jacob with UBS. Your line is open.

Operator: Yes, our next question comes from Gary Nachman with BMO Capital Markets. Your line is open.

Hi, Thanks, so much for squeezing me in here a couple if I may if we have time, but I was just on the <unk>.

Gary Jay Nachman: Thanks. A couple more questions on RINVOKE. Are you hearing anecdotally from physicians that may be switching patients from ZellGen to RINVOKE in RA if there's a perceived safety benefit with RINVOKE as a more selective jack? Are you able to take advantage of that at all?

You have the.

<unk> long term guidance of $4 billion with just the existing indications but.

The script trends at least.

It seemed to have slowed down obviously in part because narrow has been weak.

Overall therapeutic area during the pandemic, but just wondering.

Just given that the quarter itself was a little bit weaker I think versus expectations can you talk about the broader neuro market.

Gary Jay Nachman: And then secondly, if Renvo gets approved for Atopic Derm, how will you look to build out your presence with dermatologists? Will you leverage your current footprint on the aesthetic side, or will you have a completely different medical derm team? So just talk about how you're going to pursue that opportunity and how you're preparing for it, given your clear level of excitement there. Thank you. Yeah, hi, it's Jeff, and I'll take both of those.

Is that weakness there because we do see strength with <unk> and with.

Botox therapeutics. So just wondering if there's something going on specifically with Brian <unk>.

As the bipolar depression opportunity Ben.

<unk> talked for some reason and what what can you what do you what can you would need to do to accelerate growth for radar with the existing.

Indications, that's number one and number two on <unk> book.

Geoff Stewart: So we aren't actually hearing physicians, you know, from our intelligence from our field teams actively thinking to switch patients from Xeljanz to RINVOC. I mean, that's a big decision for a physician. What we have heard is when we do some of our research and listen to the ground, we clearly see that oral surveillance is perceived as a Xeljanz issue. So typically, what will happen is you may see people take their foot off the gas on some new starts, but we don't see or hear, certainly, any widespread news of active switching. So that's basically our intelligence on your first.

I think everyone understands the rates around DVT P and mace, but if you could give a little bit more clarity on based on the updated data that you filed with the agency what the rate of malignancy is.

Across the indications and whether that's.

Any different between the strengths and how that compares to the background rate. Thank you so much.

Yeah, Hi, it's Jeff I'll take the the <unk> comment.

The macro.

Geoff Stewart: In terms of your second question, we will not be using the aesthetic sales force. We will basically leverage our existing infrastructure that we have with some expansion that we've taken place for RINVOC and atopic dermatitis. I think, as you know, our reputation amongst medical derms is extremely strong. We have the number one reputation because of the years of Humira and psoriasis and psoriatic arthritis and HS, and obviously, we have a very, very strong impression and launch from Skyrizzy.

Prescription market has been down a little bit versus historical trends.

But we really think it's simply a timing issue and I'll give you some some numbers that support that so.

Before before COVID-19 hit right in the first quarter of last year, the new to brand or the <unk> four per <unk> was about 3500, new to brand prescriptions, a week and what we saw is during COVID-19 that dropped down all the way to about 2700 that was the mid year and.

It's consistently come back up so towards the end of March we started to hit or recover that pre COVID-19 historical rates. So progresses, there and ultimately the way we see these markets functions as you recover your MBR ex momentum that <unk> will start to come. So we're encouraged on the latest trends, but youre <unk>.

Geoff Stewart: So we basically designed a sales force that, through our management, which has been connected to these derms for more than a decade and existing reps with some new reps in there, we are building, we have built a sales force that will work seamlessly with our Skyrizzy teams to give a very nice offering to those dermatologists. An important fact is that basically the overlap of those dermatologists that drive the atopic derm market is about 90% between the atopic derm market and the psoriasis market. So we feel we're well positioned in terms of how we have set up our go-to-market approach with this segment.

Is right it has been a little bit soft on the market and certainly as a brand dralon drop because of COVID-19, but is now really fully recovered and so we should see continued recovery of the momentum there so hopefully that helps.

Geoff Stewart: Thanks, Gary. Operator, next question, please.

So this is Mike I'll take your second question with respect to the right sub malignancies, excluding non melanoma skin cancer because that's the way. These rates are typically are reviewed.

Operator: Yes, our next question comes from Greg Gilbert with Truist Securities. Your line is open.

Operator: Thank you, Mike. I was interested in your oral psoriasis commentary. Are you assuming that a new bar has been set by Ducravis-Sitnab in terms of efficacy versus Otesla? And is that something you're very mindful of as you consider your own programs?

I recently described right across <unk>.

Studies with roughly 10000 patient years of experience of 0.8 events.

Per 100 patient years experience and that compared to an expected rate that was 0.9 or higher depending on the estimates. So we'll call. It in the range of about 0.9 events.

Greg Gilbert: And secondly, for Rick, I realize AbbVie was born out of a company that had devices and pharma under one roof, but clearly, you've embraced in aesthetics, for example, that good franchise building could involve drugs and devices or drugs that need to be delivered by device. Does that apply as you think ahead about ophthalmology or other areas when you consider long-term BD? Thank you. This is Mike.

No not different from that expected rate and without any difference between doses with no evidence of a dose response and nothing that we've seen in the recent work that we've done changes that that view in anyway.

Mike Severino: I'll take the first question. With respect to oral psoriasis agents, we would want to come in from an efficacy perspective with something that clearly exceeded the threshold that existed in the past with Otezola. And I think coming in at a range that is Humira-like or better would be our goal. I think if you look at, you know, BMS's TIK2, they sort of come in at that Humira-like efficacy. And so I think that is generally the range that we're talking about.

Thanks, Lee that concludes today's conference call, if you'd like to listen to a replay of the call. Please visit our website at investors Abbvie Dot com. Thanks again for joining us.

Yeah.

Thank you for your participation participants you may disconnect at this time.

Yeah.

Yes.

Okay.

Yes.

Yes.

Yes.

Okay.

Yeah.

Mike Severino: I think when one talks about, you know, a direct comparison in terms of where the bar is set, we have to look not only at efficacy but at safety and at the totality of the data. Obviously, it's extremely early for our RLR gamma T agent, but we think it is a molecule, because it impacts very well understood biology with a good understanding of where to go from an efficacy perspective and a good understanding of safety, that we can get in a range that's very competitive there.

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Right.

Okay.

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Yes.

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Yes.

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Yes.

[music].

Mike Severino: So I think we'd be looking for that Humira-like efficacy or greater as something that we would like to use to enter the space with an oral, obviously coupled with strong safety. Second question, this is Rick. I mean, I think the way we approach the markets that we operate in is we look for areas where there are significant unmet needs, and then we ultimately try to come up with solutions for those needs. Sometimes it's the drug only, is a good example of where it's a combination product, right? A device and a product.

Yeah.

Okay.

Yes.

Okay.

[music].

Okay.

Okay.

Thanks.

Okay.

Yes.

Okay.

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Yeah.

Okay.

Okay.

Thanks.

John.

Sure.

Yes.

Sure.

Okay.

Mike Severino: Robert R. Certainly, as we look at ophthalmology, we have implantable devices.

Yes.

John.

Unknown Speaker: www.larryweaver.com They're available for physicians and patients. So I'd say we tend to go for it, and we're certainly not opposed to devices being part of it, if they can add to the ability to be able to provide for an advancement in standard of care. In aesthetics, as Rob indicated,

Income.

Okay.

Yes.

Okay.

Yes.

Yeah.

Okay.

Unknown Speaker: Unidentified Speaker We're looking at what that big third is.

Unknown Speaker: [inaudible]

Okay.

Rick Gonzalez: So it's an area that, historically, many of us know well because of our experience, as you pointed out in our previous discussion.

Yes.

Yes.

Yes.

Sure.

Unknown Speaker: [inaudible]

Okay.

Operator: Thanks, Greg. Operator, we have time for one final question.

Operator: Thank you. Our last question comes from Naveen Jacob with UBS. Your line is open.

Okay.

Okay.

Yes.

Naveen Jacob: Hi, thanks so much for squeezing me in here. A couple, if I may, if we have time, but just on Braylor, you have strong long-term guidance of $4 billion with just the existing indications, but the script trends at least seem to have slowed down, obviously, in part because Nero has been weak as an overall therapeutic area during the pandemic.

Okay.

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Okay.

Naveen Jacob: But just wondering, and just given that the quarter itself was a little bit weaker, I think, versus expectations, can you talk about the broader neuromarket? Is there weakness there? Because we do see strength with Ubrella V.

Okay.

Okay.

Naveen Jacob: with Botox Therapeutics. So I was just wondering if there's something going on specifically with Braylor. Has the bipolar depression opportunity been tapped out for some reason?

Yes.

Okay.

Right.

Naveen Jacob: And what can you do...

Naveen Jacob: What do you think you would need to do to accelerate growth for rail with the existing indications? Indications, that's number one and number two on Rinvoke. I think everyone understands the rates around DVTP

Yes.

Okay.

Okay.

Okay.

Okay.

Brian.

Sure.

Naveen Jacob: and Mace. But if you could give a little bit more clarity on, based on the updated data that you've filed with the agency, what the rate of malignancy is across the indications and whether that's any different between the strengths and how that compares to the background rate. Thank you so much. Yeah, hi, it's Jeff. I'll take the Braylor comment. You know that the macro prescription market has been down a little bit versus historical trends.

Okay.

Okay.

Yes.

Okay.

Okay.

Okay.

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Okay.

Okay.

Naveen Jacob: But we really think it's simply a timing issue, and I'll give you some numbers that support that. So, Before COVID hit, right in the first quarter of last year, the new-to-brand or MBRX for Raylar was about 3,500 new-to-brand prescriptions a week. And what we saw is that during COVID, that dropped down all the way to about 2,700. That was mid-year, and then it's consistently come back up. So, towards the end of March, we started to hit or recover that pre-COVID historical rate.

Okay.

Eric.

Okay.

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Right.

Yes.

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[music].

Okay.

Naveen Jacob: So progress is there, and ultimately, the way we see these markets function, as you recover your MBRX momentum, the TRXs will start to come. So we're encouraged by the latest trends, but your point is right. It has been a little bit soft on the market, and certainly, as a brand, Braylor dropped because of COVID, but it's now really fully recovered, and so we should see continued recovery of the momentum there. So, hopefully, this is Mike.

Okay.

Okay.

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Thanks.

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Geoff Stewart: I'll take your second question. With respect to the rates of malignancies excluding non-melanoma, which is the way these rates are typically reviewed, I recently described a rate across RINVOC studies with roughly 10,000 patient years of experience of 0.8 events per 100 patient years of experience. And that compared to an expected rate that was 0.9 or higher, depending on the estimate. So we'll call it in the range.

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Chris.

Yes.

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Mike Severino: 0.9 events, so not different from that expected rate and without any difference between doses, so no evidence of a dose response. And nothing that we've seen in the recent work that we've done changes that view in any way.

John.

Okay.

Okay.

Operator: Thanks, Devine. That concludes today's conference call. If you'd like to listen to a replay of the call, please visit our website at investors.abbvie.com.

Okay.

Operator: www.abbvie.com. Thanks again for joining us. Thank you for your participation. Participants, you may disconnect at this time. ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? , , , , , , , , , , , , , ,

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Operator: Thank you for your participation. Participants, you may disconnect at this time. , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? , , , Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Good morning, and thank you for.

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Yeah.

Operator: Welcome to the AbbVie first quarter. All participants will be able to listen only until the question and answer portion of this call. May I ask a question by pressing star 1? I would now like... Vice President of Investor Relations.

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John.

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Operator: Good morning, and thank you for joining us.

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Operator: Thank you for joining us today. Our speakers on the call with me today are Rick Gonzalez, Chairman of the Board and Chief Executive Officer; Michael Severino, Vice Chairman and President; Rob Michaels, and

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Operator: Michael, Executive Vice President and Chief Financial Officer, and Geoff Stewart, Executive Vice President, Commercial Operations.

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James.

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John.

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John.

John.

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John.

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Operator: of the call is Laura Schumacher, Vice President

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Operator: Some statements we make today may be considered forward-looking.

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Operator: [inaudible] Additional information about these risks and uncertainties is included in our SEC filing. AbbVie undertakes no obligation to update these forward-looking statements except as required by law.

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Steve.

Operator: On today's conference call, non-GAAP financial measures will be used to help investors understand... Thank you all for joining us today, and we hope that these non-GAAP financial measures are reconciled with comparable GAAP financial measures in our earnings release and regulatory filings from today, which can be found on our website. Unless otherwise noted, our commentary on sales growth is on a comparable basis, which includes full current year and historical results for Allergan. For this comparison of underlying performance, all historically reported Allergan revenues have been recast to conform to AbbVie's revenue recognition accounting policy and excluded the divestitures of ZENPEP and

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Lisa.

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Steve.

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Operator: References to operational growth further exclude the impact of exchange. Following our prepared remarks, we'll take your questions. So with that, I'll now turn the call over to Rick. Thank you.

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Operator: Thank you, Liz. Good morning, everyone, and thank you for joining us today. I'll discuss our first quarter performance and outlook, and then Geoff, Mike, and Rob will review our business highlights, pipeline progress, and financial results in more detail.

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Operator: We're off to an excellent start this year, delivering strong results top and bottom.

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Unknown Speaker: [inaudible] We reported adjusted earnings per share of $2.95, saving the midpoint of our guidance by 14 cents. Total adjusted net revenues of $12.9 billion were up 5.2% on a comparable operational basis, nearly $250 million ahead of our expectations.

John.

Gary.

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Unknown Speaker: These results include strong performance across each of our core therapeutic areas, including double-digit comparable operational performance.

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Yes.

Unknown Speaker: Comparable Operational Revenue Growth from Immunology, Neuroscience, and Aesthetics, as well as High Single-Digit Operational Growth from Hematological Oncology. Additionally, we continue to see robust sales from our key and newly launched products. Sky Rizzi and Renvo contributed nearly $900 million in combined revenues this quarter, more than double the sales versus the prior year, as both products continue to ramp up in their initial indications. Rubica, and Ben Kleksta delivered combined sales of approximately $1.7 billion.

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Steve.

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Eric.

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Unknown Speaker: Reflecting Continued Leadership in CLL and Other Hematological Malignancies. Baylor, which remains one of the fastest growing medicines in psychiatry, delivered more than 20% comparable operational revenue. Ubrella. The leading oral CGRP for acute migraine generated revenue growth of approximately 25% on a sequential basis, and within our leading aesthetics portfolio, which is performing well above pre-COVID levels, Botox Cosmetics and Juvederm are demonstrating robust performance. Both of these brands grew more than 40% on a comparable basis.

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Steve.

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Steve.

Good morning, and thank you for standing by welcome to the Abbvie first quarter 2021 earnings Conference call. All participants will be able to listen only until the question and answer portion of this call. You may ask a question by pressing star one on your phone.

Unknown Speaker: on a comparable operational basis.

Unknown Speaker: The integration of Allergan also continues to go very well. As illustrated by our balanced results this quarter, we are clearly demonstrating that we have created a stronger and much more diverse company. Scale and Flexibility to Fully Invest in the Business for Long-Term Growth. While the pandemic has categorically impacted our day-to-day lives, we are encouraged by the latest recovery trends.

I would now like to introduce MS. Liz Shea Vice President of Investor Relations.

You may begin good morning, and thanks for joining US also on the call with me today are reconciling chairman of the board and Chief Executive Officer, Michael Severino, Vice Chairman and President, Rob, Michael Executive Vice President and Chief Financial Officer, and Jeff Stuart Executive Vice President commercial operation joining us for the Q&A portion of the call is Laura Schumacher.

Unknown Speaker: We see marked growth and new patient activity increasing overall.

Unknown Speaker: especially in March, although certain markets continue to remain below pre-COVID levels, including CLL and HCV in particular. We expect that increasing vaccinations globally will continue to support a full recovery across our therapeutic areas as we progress through the remainder of this year. Based on a robust performance this quarter and the continued strong outlook for our business, we are raising our full-year 2021 EPX guide, and we now expect adjusted earnings per share between $12.37 and $12.57, reflecting growth of more than 18%.

<unk> Vice Chairman external affairs, Chief legal officer, and corporate Secretary before we get started I remind you that some statements. We make today may be considered forward looking statements for purposes of the private Securities Litigation Reform Act of 1995 Abbvie.

Abbvie cautions that these forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward looking statements.

Information about these risks and uncertainties is included in our SEC filings Abbvie.

Undertakes no obligation to update these forward looking statements, except as required by law.

On today's conference call non-GAAP financial measures will be used to help investors understand abbvie.

This performance these non.

GAAP financial measures are reconciled with comparable GAAP financial measures in our earnings release and regulatory filings from today, which can be found on our website and Lee.

Yes, otherwise noted our commentary on sales growth is on a comparable basis, which includes full current year and historical results for Allergan for this comparison of underlying performance. All historically reported Allergan revenues have been recast to conform to Abbvie is revenue recognition accounting policy and excluded the divestitures of non top in biotech.

Unknown Speaker: 18% at the midpoint.

Unknown Speaker: I'm also extremely pleased with our R&D prospects, including the number and potential of the opportunities, especially within our late-stage pipeline. We're on the cusp of the potential commercial approval of more than a dozen new products or indications over the next two years, including five total expected approvals in 2021. This includes ToeJapan, a novel oral CGRP for epilepsy.

References to operational growth further excludes the impact of its James.

Following our prepared remarks, we'll take your questions. So with that I'll now turn the call over to Rick.

Thank you Liz and good morning, everyone and thank you for joining us today I'll discuss our first quarter performance and outlook and then Jeff Mike and Rob will review, our business highlights pipeline progress and financial results in more detail.

Unknown Speaker: for Episodic Migraine, adding to our already attractive migraine portfolio.

Unknown Speaker: A new eyedrop for the treatment of presbyopia, as well as expanded indications for RENVO and psoriatic arthritis, ankylosing spondylitis, and atopic dermatitis. And we expect more than half a dozen new product or indication launches in 2022, including Neviticlax for myelofibrosis. 951 for advanced Parkinson's disease, Sky Rizzi for psoriatic arthritis and Crohn's disease, and Renvo for Ulcerative Colitis. Velar for Major Depressive Disorder and Additional Indications for Embruvica and Venclexa.

We're off to an excellent start this year delivering strong top and bottom line first quarter performance, we reported adjusted earnings per share of $2 95.

Exceeding the midpoint of our guidance by <unk> 14.

Total adjusted net revenues of $12 $9 billion was up five 2% on a comparable operational basis nearly $250 million ahead of our expectations.

These results include strong performance across each of our core therapeutic areas, including double digit comparable operational revenue growth from immunology neuroscience and aesthetics as well as high single digit operational growth from Hematological oncology.

Unknown Speaker: With these collective new growth opportunities and the continued momentum of our underlying portfolio, our long-term outlook remains very strong. In closing, our focus remains on strong commercial and operational execution, as well as pipeline advancement. I'm pleased with the financial results for the quarter and the overall pace of the recovery across our portfolio. We're off to another excellent start in 2021. With that, I'll end the call.

Additionally, we continue to see robust sales from our key and newly launched products <unk> and <unk> contributed nearly $900 million in.

And combined revenues this quarter more than double the sales versus the prior year as both products continue to ramp in their initial indications.

Okay, and then collect stuff delivered combined sales of approximately $1 7 billion.

Unknown Speaker: With that, I'll turn the call over to Geoff for additional comments on our commercial highlights. Geoff?

Unknown Speaker: Thank you, Rick. We demonstrated strong and balanced growth across our therapeutic portfolio this quarter, a testament to our differentiated product profiles. Commercial Execution Our immunology portfolio delivered global revenues of more than $5.7 billion, reflecting growth of nearly 12% on an operational basis. Samara sales were approximately $4.9 billion, up 2.6% on an operational basis, with continued high single-digit growth in the U.S.

Reflecting continued leadership in <unk> and other Hematological malignancies.

Villard, which remains one of the fastest growing medicines in psychiatry and delivered more than 20% comparable operational growth.

<unk>.

Leading oral <unk> for acute migraine generated revenue growth of approximately 25% on a sequential basis.

And within our leading aesthetics portfolio, which is performing well above pre COVID-19 levels Botox cosmetics and juvederm are demonstrating robust performance. Both of these both of these brands grew more than 40% on a comparable operational basis.

Unknown Speaker: Offset by biosimilar competition across our international markets, where the unfavorable impact was more moderate than expected in the quarter. Our new immunology agents, Skyrizzy, and RINVOC, are both demonstrating robust prescription growth, well above all comparable launches. Skyrizzy sales were $574 million, reflecting 34% of in-play patients, which includes new and switching. This is more than double the share captured by the next nearest biologic competitor. Guy Rizzi's total prescription share in the U.S. psoriasis biologic market is now approximately 15 percent, second only to Humira.

The integration of Allergan also continues to go very well as illustrated by our balanced results. This quarter. We are clearly demonstrating that we have created a stronger and much more diverse company with the scale and flexibility to fully invest in the business for long term growth.

While the pandemic is categorically impacted our day to day lives. We are encouraged by the latest recovery trends, we see market growth in new patient activity, increasing overall, especially in March although certain markets continue to remain below pre COVID-19 levels, including <unk>.

<unk> and <unk> in particular.

We expect the increasing vaccinations globally, we will continue to support a full recovery across our therapeutic areas as we progress through the remainder of this year.

Unknown Speaker: Additionally, we recently received approval for a single-dose, pre-filled pen for Sky, which will reduce the number of injections per treatment. Guy Rizzi is now the only quarterly dose psoriasis treatment available in an auto-injector, further improving the patient experience.

Based on our robust performance this quarter and the continued strong outlook for our business. We are raising our full year 2021, EPS guidance and we now expect adjusted earnings per share between $12 37.

Unknown Speaker: Renvoke sales were $303 million, with strong in-play patient share of approximately 15% in the USRA market. Physician and patient feedback remained very positive on RINVO's level of efficacy, speed of response, and strong benefit-risk profile. Internationally, both of these new assets delivered strong double-digit sequential growth with ramping access and share.

And $12 57.

Reflecting growth of more than 18% at the midpoint.

I'm also extremely pleased with our R&D prospects, including the number and potential of the opportunities, especially within our late stage pipeline.

We're on the cusp of the potential commercial approval more than dozen new products or indications over the next two years, including five total expected approvals in 2021.

Unknown Speaker: Guy Rizzi has now also achieved in-play patient share leadership in the EU5 psoriasis market, exceeding FIAA and Cosentix and at parity with TALC. As Mike will discuss momentarily, we are also making considerable progress to expand the uses of Skyrizzian-Rinvoke in several immune-mediated diseases, with half a dozen additional indication approvals expected later this year and in 2020. In hematologic oncology, sales were approximately $1.7 billion, up 7.3% on an operational basis. And Rubica continues to perform well across multiple indications, including CLL, where it remains the clear market share leader across all lines of therapy.

This includes the total Japan, a novel oral <unk> for episodic migraine, adding to our already attractive migraine portfolio.

A new eye drop for the treatment of presbyopia.

As well as expanded indications for <unk> in Psoriatic arthritis, ankylosing spondylitis and atopic dermatitis.

And we expect more than a half a dozen new product or indication launches in 2022, including <unk> for myelofibrosis ABV 95, one for advanced Parkinson's disease, Skype for Psoriatic arthritis, and Crohn's disease RIN.

<unk> for ulcerative colitis.

Laura for major depressive disorder, and an additional indications for <unk> and <unk>.

Unknown Speaker: The Bruvica sales increased 2.9% on an operational basis this quarter, with performance impacted by lower new patient starts within CLL, where the market remains below pre-COVID, Rubica growth was also unfavorably impacted by the COVID-related stocking benefits, saw in the first quarter of, And Clexta sales were $405 million, up 24.5% on an operational basis, with increasing share in Frontline CLL and continued strong performance in AIM. Neuroscience.

With these collective new growth opportunities and the continued momentum of our underlying portfolio. Our long term outlook, our long term outlook remains very strong.

In closing our focus remains on strong commercial and operational execution as well as pipeline advancement.

I am pleased with the financial results for the quarter and the overall pace of the recovery across our portfolio.

We're off to another excellent start in 2021 with that I'll turn the call over to Jeff for additional comments on our commercial highlights Jeff.

Thank you, Rick we demonstrated strong and balanced growth across our therapeutic portfolio. This quarter, a testament to our differentiated product profiles and commercial execution, our immunology portfolio delivered global revenues of more than $5 7 billion.

Unknown Speaker: Revenues were more than $1.2 billion, up 10.9% on a comparable operational basis. Raylar once again delivered strong growth. Sales of $346 million were up 21.2% on a comparable operational basis, reflecting a nearly 2.5% total prescription share of the U.S. atypical antipsychotic market. Within Migraine, the launch of Ubrelvi is exceeding our expectations, with $81 million of revenue in the quarter. Feedback from physicians has been very positive, highlighting Ubrelvi's efficacy, safety, convenient dosing profile, and overall commercial accuracy. Abrelvi is the number one branded acute treatment for migraine, based on both new patient share and prescription growth.

Reflecting growth of nearly 12% on an operational basis.

Humira sales were approximately $4 9 billion up two 6% on an operational basis with continued high single digit growth in the U S.

Offset by Biosimilar competition across our international markets, where the unfavorable impact was more moderate than expected in the quarter.

Our new immunology agents <unk> and <unk> are both demonstrating robust prescription growth well above all comparable launches.

<unk> sales were $574 million, reflecting 34% in play patient share, which includes new and switching patients. This is more than double the share capture of the next nearest biologic competitor.

Unknown Speaker: The oral CGRP therapies, including our leading Ubrelvi, now represent roughly 16% of new prescriptions in the large acute migraine market. We believe there is substantial room for long-term growth in this rapidly expanding segment based on unmet need and strong... We also look forward to the expected commercial approval of ToeJapan, our oral CGRP therapy for episodic migraine, later this year. Botox Therapeutic is seeing a very nice recovery in chronic migraine, as well as other indicators. Total sales of $532 million, up 7% on a comparable operation.

<unk> total prescription share in the U S. Psoriasis biologic market is now approximately 15% second only to Humira.

Additionally, we recently received approval for a single dose Prefilled pen for Sky, Rizzi, which will reduce the number of injections per treatment.

<unk> is now the only quarterly dose psoriasis treatment available in an auto injector further improving the patient experience.

<unk> sales were $303 million with strong in play patient share of approximately 15% in the U S <unk> market physician and.

Unknown Speaker: Lastly, and our other key therapeutic areas. We saw significant contribution from iCare, which had revenues of $817 million. Maverick sales were $415 million.

Patient feedback remained very positive on rent bumps level of efficacy speed of response and strong benefit risk profile.

Unknown Speaker: Down 28.4% on an As treated patient volumes have remained below pre-COVID, we also saw double-digit comparable growth from Linzess, the leading branded prescription medicine in the U.S. for the treatment of adults with IBSC or chronic idiopathic. Overall, I am extremely pleased with our execution across the therapeutic portfolio, including the progress we are making with our recent new product. We remain on track to deliver very strong revenue growth. With that, I'll turn the call over to Mike for additional comments on our R&D. Thank you, Geoff.

Internationally both of these new assets delivered strong double digit sequential growth with ramping access and share.

Guy Ritchie has now also achieved in play patient share leadership in the EU five psoriasis market exceeding from fire and Concentrix and at parity with pulse.

As Mike will discuss momentarily. We are also making considerable progress to expand the uses of <unk> and <unk> in several immune mediated diseases with half a dozen additional indication approvals expected later this year and in 2022.

And.

<unk> oncology sales were approximately $1 7 billion up seven 3% on an operational basis improve OCA continues to perform well across multiple indications, including CLO, where it remains the clear market share leader across all lines of therapy.

Unknown Speaker: I'll start with immunology, where we continue to make good progress with RINVOC and SCIRIS-E in new disease areas, as well as in our early and mid-stage immunology programs. We recently reported positive top-line results from the second induction study for RINVOC and ulcerative colitis. Similar to results from the first induction study, in this Phase 3 trial, RINVOC demonstrated a very strong impact on disease activity as measured by clinical remission, clinical response, and endoscopic improvement. The 45 mg induction dose was well tolerated, and the safety profile was consistent with previous RENVOGUE studies. In these induction trials, we saw no DVT, PE, MACE events, or malignancies in the RINVOTE groups.

<unk> sales increased two 9% on an operational basis this quarter with performance impacted by lower new patient starts within CLO, where the market remains below pre COVID-19 levels in.

<unk> growth was also unfavorably impacted by the COVID-19 related stocking benefit that we saw in the first quarter of 2020.

<unk> sales were $405 million up 24, 5% on an operational basis with increasing share in frontline <unk> and continued strong performance in AML.

In neuroscience revenues were more than $1.2 billion up 10, 9% on a comparable operational basis <unk> once again delivered strong growth.

Unknown Speaker: And the rates of serious adverse events were numerically lower than placebo. We believe these induction data compare very favorably to other UC treatments on the market or in development, and based on the data generated to date, RINVOC has the potential to become one of the most highly effective treatments for patients with moderate to severe ulcerative colitis. We expect to see results from the UC maintenance study this summer, with regulatory submissions anticipated in the second half of the year.

<unk> of $346 million were up 21, 2% on a comparable operational basis.

<unk> and nearly two 5% total prescription share of the U S atypical antipsychotic market.

Within migraine the launch of your <unk> is exceeding our expectations with $81 million of revenue in the quarter feed.

Feedback from physicians has been very positive highlighting <unk> efficacy safety convenient dosing profile and overall commercial access.

Unknown Speaker: The RINVOKE program in Crohn's disease is also progressing very well, and we expect to see induction data from the first of two phase three trials in the fourth quarter, followed by induction data from a second phase three trial and maintenance data in the first half of 2022. We're also nearing completion of our pivotal program for Sky RISD in Cron. Earlier this year, we reported positive results from the two Crohn's induction studies, and we expect to see maintenance data this summer.

<unk> is the number one branded acute treatment for migraine based on both new patient share and prescription growth.

The oral <unk> therapies, including our leading <unk> now represent roughly 16% of new prescriptions and the large acute migraine market.

We believe there is substantial room for long term growth in this rapidly expanding segment based on unmet need and strong patient demand.

We also look forward to the expected commercial approval of a toll Japan, our oral <unk> for episodic migraine later this year.

Botox therapeutic is seeing a very nice recovery in chronic migraine as well as its other indications with total sales of $532 million up 7% on a comparable operational basis.

Unknown Speaker: Our regulatory submissions for Skyrizzian Crohn's disease remain on track for the second half of 2021. Following completion of our registrational program for SCIRIS-E in psoriatic arthritis, we recently submitted our regulatory applications in the U.S. and Europe, with approval decisions expected in the first half of 2022. We're very pleased with the level of activity we saw with SCIRIS-E on both joint disease and skin clearance in our Phase 3 program and look forward to providing this new treatment to patients suffering from psoriatic arthritis.

Lastly in our other key therapeutic areas we.

We saw significant contribution from eyecare, which had revenues of $817 million Maverick sales were 415 million.

Down 28, 4% on an operational basis as treated patient volumes have remained below pre COVID-19 levels and.

And we also saw double digit comparable growth from Linzess, the leading branded prescription medicine in the U S for the treatment of adults with Ibs C or chronic idiopathic constipation.

Overall, I am extremely pleased with our execution across the therapeutic portfolio, including the progress we're making with recent new product launches. We remain on track to deliver a very strong revenue growth in 2021, and with that I'll turn the call over to Mike for additional comments on our R&D programs Mike.

Unknown Speaker: Our regulatory submissions are currently under review for RINVOC in three new indications in the U.S., ankylosing spondylitis, psoriatic arthritis, and atopic dermatitis. As we previously announced, the FDA recently extended the review periods for RINVOC in psoriatic arthritis and atopic dermatitis following a request for an updated assessment of the benefit-risk profile for RI In response to the FDA request, we provided updated data from across RINVOC programs in RA, psoriatic arthritis, and atopic dermatitis.

Thank you Jeff.

I'll start with immunology, where we continue to make good progress with <unk> and Sky racing in new disease areas as well as in our early and mid stage immunology programs.

We recently reported positive top line results from the second induction study for <unk> in ulcerative colitis.

Similar to results from the first induction study in this phase III trial revoke demonstrated a very strong impact on disease activity as measured by clinical remission clinical response, and then Scopic improvement.

Unknown Speaker: Based on the review extensions, we now expect approval decisions for psoriatic arthritis in June and for atopic dermatitis in July. The regulatory action date for RINVOC and ankylosing spondylitis is unchanged and remains on track for June.

The 45 milligram induction dose was well tolerated and the safety profile was consistent with previous <unk> studies.

In these induction trials, we saw no DVT PE mace events for malignancies in the Rainbow groups and the rates of serious adverse events were numerically lower than placebo.

Unknown Speaker: We remain confident in the benefit-risk profile of RINVOC across all indications and will work with the FDA to bring RINVOC to market in these new disease areas. Earlier this year, we received European approval for Rinvokin's psoriatic arthritis product, NAS. Our European regulatory application for RINVOC and atopic dermatitis is under review, and we remain on track for a CHMP opinion this summer, with an approval decision anticipated in the third quarter. We also recently saw results from a four-week Phase 1B study evaluating our novel small molecule ROR-gamma-T inverse agonist. 157, Inpatients with psoriasis.

We believe these induction data compare very favorably to other UC treatments on the market or in development and based on the data generated to date <unk> has the potential to become one of the most highly effective therapies for patients with moderate to severe ulcerative colitis.

We expect to see results from the UC maintenance study this summer with.

With regulatory submissions anticipated in the second half of the year.

The <unk> program in Crohn's disease is also progressing very well and we expect to see induction data from the first of two phase III trials in the fourth quarter, followed by induction data from our second phase III trial and maintenance data in the first half of 2022.

Unknown Speaker: By targeting ROR gamma-T with an inverse agonist rather than an antagonist, we believe we can more effectively inhibit IL-17 production, thus resulting in a greater impact on skin inflammation. In our Phase 1B study, 157 showed promising activity as an oral psoriasis agent, and we plan to move the asset forward to a larger Phase 2B dose-ranging study in the second half of this year. Moving now to our oncology portfolio, we continue to make very good progress with our late-stage programs for imbruvica, then clexta, and nididoclax, as well as with our early-stage oncology assets. We remain on track for several key regulatory submissions, data presentations, and phase transitions this year. For example, at the upcoming ASCO and EHA meetings.

We're also nearing completion of our pivotal program for <unk> in Crohn's disease.

Earlier this year, we reported positive results from the two Crohn's induction studies, and we expect to see maintenance data this summer.

Our regulatory submissions for <unk> in Crohn's disease remain on track for the second half of 2021.

Following completion of our Registrational program for <unk> in Psoriatic arthritis, we recently submitted our regulatory applications in the U S and Europe with approval decisions expected in the first half of 2022.

Unknown Speaker: We will be presenting more than 40 abstracts, including results from the Imbruvica Plosvenklextecaptidae trial, a fixed-duration cohort in treatment-naive CLL patients. The Imbruvica-venclexa combination is an important element of our HEMON strategy to provide a differentiated, fixed-duration treatment that offers deeper levels of response. Data from our Imbruvica-venclexta combination studies will support regulatory submissions in frontline CLL later this year. We will also be presenting four-year follow-up data from Venclexta's CLL14 trial in frontline CLL, as well as updated efficacy and safety data from a Phase 1B study evaluating Venclexta plus azacitidine in treatment-naive, high-risk

We're very pleased with the level of activity, we saw with Sky Rizzi on both joint disease, and skin clearance and our phase III program and look forward to providing this new treatment to patients suffering from Psoriatic arthritis.

Our regulatory submissions are currently under review for invoke in three new indications in the U S.

Ankylosing spondylitis, psoriatic arthritis, and atopic dermatitis.

As we previously announced the FDA recently extended the review periods for invoke in Psoriatic arthritis, and atopic dermatitis. Following our request for an updated assessment of the benefit risk profile for <unk> in these indications.

In response to the FDA request, we provided updated data from across invoke programs and RA psoriatic arthritis, and atopic dermatitis.

Based on the review extensions, we now expect approval decisions for Psoriatic arthritis in June and for atopic dermatitis in July.

Unknown Speaker: We expect this MDS study to complete in the second half of this year, and if positive, it could support a submission in the first half of 2022 to seek an accelerated approval in the area of solid tumors. At the recent AACR meeting, we presented Phase 2 results for TELUSO-V in non-squamous, non-small cell lung cancer. In this study, TELUSO-B demonstrated promising response rates in heavily pre-treated patients. Particularly in patients with highly expressed C-MET, where we saw a 54% objective response, CMET is an attractive target across multiple tumor types, particularly in non-small cell lung cancer, where approximately 30% of patients have overexpressed CMET.

The regulatory action date for invoking ankylosing spondylitis is unchanged and remains on track for June.

We remain confident in the benefit risk profile of <unk> across all indications and we will work with the FDA to bring <unk> to market and these new disease areas.

Earlier this year, we received European approval for invoke in Psoriatic arthritis, and a S.

Our European regulatory application for <unk> in atopic dermatitis is under review and we remain on track for the HMP opinion. This summer with an approval decision anticipated in the third quarter.

We also recently saw results from a four week phase <unk> study evaluating our novel small molecule ror Gamma T inverse agonist.

Unknown Speaker: Approaches in this area have historically focused on small molecule kinase inhibitors and anti-SUMET antibodies, both of which have shown only limited efficacy in this patient population and have not been sufficient for approval. In contrast, our CMET antibody drug conjugate is a novel approach that we believe will have broader applicability and will provide enhanced efficacy compared to previous approaches. We recently began the second stage of our Phase II study, which has the potential to support an accelerated approval in second line plus, metastatic, non-squamous, non-small cell lung cancer.

<unk> 157 in patients with psoriasis.

By targeting Ror Gamma T with an inverse agonist rather than an antagonist. We believe we can more effectively inhibit IL 17 production, thus, resulting in a greater impact on skin inflammation.

In our phase <unk> study $105 seven showed promising activity as an oral psoriasis agent and we plan to move the asset forward to a larger phase <unk> dose ranging study in the second half of this year.

Moving now to our oncology portfolio.

We continue to make very good progress with our late stage programs for <unk>, <unk> and EBITDA <unk> as well as with our early stage oncology assets.

Unknown Speaker: We also plan to evaluate TELUSO-V in the frontline setting, including in combination with other agents, as well as in other C-met positive tumor types. We also have a next generation CMET ADC program that will be entering the clinic later this year. Our new CMET ADC, ABBV400, utilizes a topoisomerase inhibitor payload, which we believe will provide greater anti-tumor efficacy against both amplifified MET and overexpressed CMET subtypes.

We remain on track for several key regulatory submissions data presentations and phase transitions this year.

At the upcoming <unk> and <unk> meetings, we will be presenting more than 40 abstracts, including results from the <unk> plus a bank likes that captivate trial fixed duration cohort in treatment naive CLO patients.

The improve of kind of then collects the combination is an important element of our hemo on strategy to provide a differentiated fixed duration treatment that offers deeper levels of response.

Data from our <unk> and <unk> combination studies will support regulatory submissions in frontline <unk> later this year.

Unknown Speaker: Thus providing deeper responses with broader applicability than other anti-CMET targeting. In neuroscience, we recently presented data from several key programs at the American Academy of Neurology annual meeting. A total of 33 abstracts were presented, including Data from the Phase 3 ADVANCE Study in Episodic Migraine Prevention showing that Itojipan has the potential to be a highly effective, safe, and well-tolerated oral treatment option with a rapid onset of action. The FDA recently accepted our NDA for Itojipan for the prevention of episodic migraine, and an approval decision is expected in September of this year.

We will also be presenting four year follow up data from the <unk> CLO 14 trial in frontline CLO as well as updated efficacy and safety data from a phase <unk> study evaluating <unk> plus <unk> in treatment naive high risk Mds patients.

We expect this Mds study to complete in the second half of this year and if positive it could support a submission in the first half of 2022 to seek an accelerated approval.

In the area of solid tumors at the recent ACR meeting, we presented phase III results for <unk> in non squamous non small cell lung cancer.

Unknown Speaker: We also presented results from an open-label Phase III study evaluating Ubrella V in perimenstrual migraines, which showed that Uprovy has potential as a safe and efficacious treatment for migraine attacks that occur during or near menstruation. Menstrual migraine attacks can be more difficult to treat because they are often longer in duration, more severe, and often resistant to treatment.

In this study <unk> demonstrated promising response rates in heavily pretreated patients, particularly in patients with highly express <unk>, where we saw a 54% objective response rate.

<unk> is an attractive target across multiple tumor types, particularly in non small cell lung cancer, where approximately 30% of patients have over express <unk>.

Unknown Speaker: And we presented data from a phase one study demonstrating that ABBV951 subcutaneous infusions maintain an equivalent levodopa exposure to duopa in advanced Parkinson's patients. Results from the pivotal program for ABBV 951 are expected this summer, with regulatory submissions anticipated in the second half of this year. We also remain on track for readouts in the fourth quarter from two phase three studies for VRELAR, an adjunctive treatment for major depressive disorder, and if successful, we would anticipate regulatory submissions in the first half of 2022.

Approaches in this area have historically focused on small molecule kinase inhibitors and anti <unk> antibodies.

Both of which have shown only limited efficacy in this patient population that has not been sufficient for approval in.

In contrast, our cement antibody drug conjugate is a novel approach that we believe will have broader applicability and will provide enhanced efficacy compared to previous approaches.

We recently began the second stage of our phase II study, which has the potential to support an accelerated approval in second line plus metastatic non squamous non small cell lung cancer.

We also plan to evaluate <unk> in the frontline setting, including in combination with other agents as well as in other <unk> positive tumor types.

Unknown Speaker: In eye care, we submitted our regulatory application in the U.S. for AGN 190584 for the treatment of symptoms associated with presbyopia. 584 is a once daily eyedrop being developed to help address symptoms that are often corrected through reading glasses. This new technology represents a complementary product to reading glasses and would be a convenient on-demand solution for patients with mild to moderate presbyopia.

We also have a next generation <unk> ADC program that will be entering the clinic later this year.

Our new C met ADC ABV 400 utilizes a <unk> inhibitor payload, which we believe will provide greater anti tumor efficacy against both amplified Matt and over expressed <unk> subtypes. Thus.

Thus, providing deeper responses with broader applicability than other anti <unk> targeting agents.

Unknown Speaker: An approval decision is expected in the fourth quarter of this year, and Anesthetics. We're investing to accelerate key next-generation toxins and filler programs. By combining the aesthetic team's deep expertise with AbbVie's breadth and scale of resources, we'll be able to bring novel products to market significantly faster. Looking across our portfolio, we've identified a number of programs to accelerate, including our short-acting and long-acting toxins, as well as our next-generation biostimulatory tropoelastin and collagen fillers.

In neuroscience, we recently presented data from several key programs at the American Academy of Neurology annual meeting.

Total of 33 abstracts were presented including.

Data from the Phase III advance study in episodic migraine prevention, showing that until Japan has the potential to be a highly effective safe and well tolerated oral treatment option with a rapid onset of action.

The FDA recently accepted our NDA for Japan for the prevention of episodic migraine and an approval decision is expected in September of this year.

Unknown Speaker: Acceleration of these programs is expected to drive significant long-term growth for the aesthetics franchise. So, in summary, we've continued to make significant progress with our pipeline to start the year, and we look forward to many more data readouts, regulatory submissions, and approvals throughout the remainder of 2021. With that, I'll turn the call over to Rob for additional comments on our first quarter performance and financial outlook. Rob, thank you, Mike.

We also presented results from an open label Phase III study evaluating <unk> and Peri menstrual migraine.

It showed that <unk> has potential as a safe and efficacious treatment of migraine attacks that occurred during or near menstruation.

Menstrual related migraine attacks can be more difficult to treat because they are often longer in duration more severe and often resistant to treatment.

And we presented data from our phase one study demonstrating that ABB. The 95, one subcutaneous infusion maintain an equivalent levodopa exposure to duopoly in advanced Parkinson's patients.

Unknown Speaker: Starting with first quarter results, we reported adjusted earnings per share of $2.95, up 21.9% compared to the prior year and above our guidance midpoint. Total adjusted net revenues were $12.9 billion, up 5.2% on a comparable operational basis, excluding a 1.1% favorable impact from foreign exchange. The adjusted operating margin ratio was 51% of sales, an improvement of 120 basis points versus the prior year. This includes adjusted gross margin of 83.9% of sales, adjusted R&D investment of 11.6% of sales, and adjusted SG&A expense of 21.2% of sales.

<unk> from the pivotal program for ABB 95, one are expected this summer with the regulatory submission is anticipated in the second half of this year.

We also remain on track for Readouts in the fourth quarter from two phase III studies for <unk> in adjunct and major depressive disorder, and if successful we would anticipate regulatory submissions in the first half of 2022.

Yes.

In eye care, we submitted our regulatory application in the U S for AGN 190584 for the treatment of symptoms associated with presbyopia.

<unk> is a once daily eye drop being developed to help address symptoms that are often corrected through reading glasses.

This new technology represents a complementary product to reading glasses and would be a convenient on demand solution for patients with mild to moderate presbyopia.

Unknown Speaker: Net interest expense was $622 million, and the adjusted tax rate was 12.3%. As Rick previously mentioned, we are raising our full-year adjusted earnings per share guidance to between $12.37 and $12.57, reflecting growth of 18.1% at the midpoint. Excluded from this guidance is $5.10 of known intangible amortization and specified items.

An approval decision is expected in the fourth quarter of this year.

And in aesthetics, we are investing to accelerate key next generation toxins and filler programs.

By combining the aesthetic team's deep expertise with Abbvie is breadth and scale of resources, we'll be able to bring novel products to market significantly faster.

Looking across our portfolio, we've identified a number of programs to accelerate including our short acting and long acting toxins as well as our next generation bio stimulatory, Triple Elastin and college and fillers.

Unknown Speaker: This guidance now contemplates full-year revenue growth of 9.8% on a comparable operational basis. At current rates, we continue to expect foreign exchange to have a 1% favorable impact on full-year comparable sales growth. This implies a full-year revenue forecast of approximately $55.9 billion. Included in this guidance are the following updated failure assumptions. We now expect international HUMERA revenue of approximately $3.1 billion, and we now expect Botox cosmetic sales of approximately $1.9 billion. All other FOIA assumptions remain unchanged.

Acceleration of these programs is expected to drive significant long term growth for the aesthetics franchise.

So in summary, we've continued to make significant progress with our pipeline to start the year and we look forward to many more data readouts regulatory submissions and approvals throughout the remainder of 2021.

With that I'll turn the call over to Rob for additional comments on our first quarter performance and financial outlook, Rob. Thank you, Mike starting with first quarter results, we reported adjusted earnings per share of $2 95.

Unknown Speaker: As we look ahead to the second quarter, we anticipate net revenue approaching $13.6 billion. Additionally, at current rates, we expect foreign exchange to have a 1.6% favorable impact on comparable sales growth. We expect adjusted earnings per share between $3.05 and $3.09, excluding approximately $1.78 of known intangible amortization and specified items. Finally, we continue to make great progress on our Allergan Transaction Commitment. We realized over $360 million in expense synergies in the first quarter and are on track to deliver synergies of approximately $1.7 billion in 2021 and greater than $2 billion in 2022.

Up 21, 9% compared to prior year and above our guidance midpoint.

Total adjusted net revenues were $12 9 billion.

Five 2% on a comparable operational basis, excluding a one 1% favorable impact from foreign exchange.

The adjusted operating margin ratio was 51% of sales an improvement of 120 basis points versus the prior year. This includes adjusted gross margin of 83, 9% of sales adjusted R&D investment of 11, 6% of sales and adjusted SG&A expense of 21, 2% of sales.

Net interest expense was $622 million and the adjusted tax rate was 12, 3%.

As Rick previously mentioned, we are raising our full year adjusted earnings per share guidance to between $12 37.

And $12 57.

Unknown Speaker: We have already paid down $10.4 billion of combined company debt. We continue to expect a cumulative debt paydown of $17 billion by the end of 2021, with further deleveraging through 2023. This will bring our net leverage ratio to 2.4 times by the end of 2021 and approximately two times by the end of 2022. In closing, we are off to an excellent start to the year, with strong performance across the portfolio and financial results ahead of our expectations. With that, I'll turn the call back over to Liz.

Reflecting growth of 18, 1% at the midpoint.

Excluded from this guidance is $5.10 of.

Of known intangible amortization and specified items.

This guidance now contemplates full year revenue growth of nine 8% on a comparable operational basis at current rates. We continue to expect foreign exchange to have a 1% favorable impact on full year comparable sales growth.

This implies a full year revenue forecast of approximately $55 9 billion.

Included in this guidance are the following updated full year assumptions, we now expect international Humira revenue of approximately $3 1 billion.

And we now expect botox cosmetic sales of approximately $1 9 billion.

Unknown Speaker: Thanks, Rob. We will now open the call for questions. In the interest of hearing,

All other full year assumptions remain unchanged.

As we look ahead to the second quarter, we anticipate net revenue approaching $13 $6 billion at current rates, we expect foreign exchange to have a one 6% favorable impact on comparable sales growth.

Unknown Speaker: [inaudible]

Unknown Speaker: We ask that you please limit your questions to one or two. Operators, first question please.

Unknown Speaker: Our first question comes from Chris Schott with J.P. Morgan. Your line is open.

We expect adjusted earnings per share between $3, <unk> and $3 nine <unk>.

Unknown Speaker: Great, thanks so much.

Unknown Speaker: Thank you so much for the questions. The first one for me was on RINVOC and dose.

Excluding approximately $1 78.

Unknown Speaker: As we think about FDA, I guess, balancing the lowest effective dose versus incremental efficacy and safety risks, I guess, what would the impact of only having a 15 milligram versus a 15 and 30 milligram approval have on your view of the atopic derm opportunity, which I think you talked about as about a $2 billion sales potential previously? And then my second question was just a little bit more color on the aesthetic dynamics. I guess, is there anything we're seeing with the results we're seeing very, very strong here? Is there any catch-up type event as the world reopens that we're seeing with these results?

Known intangible amortization and specified items.

Finally, we continue to make great progress on our Allergan transaction commitments, we realized over $360 million of expense synergies in the first quarter and are on track to deliver synergies of approximately $1 7 billion in 2021 and greater than $2 billion in 2020.

Two.

We have already paid down $10 $4 billion of combined company debt. We continue to expect cumulative debt paydown of $17 billion by the end of 2021 with further deleveraging through 2023. This will bring our net leverage ratio to two four times by the end of 2021 and approximately.

Unknown Speaker: Or are these kind of sustainable underlying trends that are kind of coming in above expectations for that business? Trying to get a sense of just how to think about that progressing as we go through the rest of the year. Thanks so much. So, Chris. This is Mike.

Two times by the end of 2022.

In closing we are off to an excellent start to the year with strong performance across the portfolio and financial results ahead of our expectations.

With that I'll turn the call back over to Liz. Thanks, Rob We will now open the call for questions and the interest of hearing from as many analysts as possible over the remainder of the call. We ask that you. Please limit your questions to one or two.

Unknown Speaker: I'll take the first question, and then Rick will take the second question that you asked. With respect to RINVOC, we feel very confident in the benefit-risk profile across indications and across the doses that we've studied. Having said that, both the 15 and 30 milligram doses performed very well, both from an efficacy and safety perspective. And so if you look at the efficacy results that we drove with 15 in atopic dermatitis, we drove high levels of response, very rapid response, and had a very prominent impact on itch, which is one of the most bothersome symptoms with 15, as well as with 30.

Operator first question please.

Our first question comes from Chris Schott with Jpmorgan. Your line is open.

Great. Thanks, so much for the questions.

First one for me was on RIN Voake and dose.

If you think about F T I guess balancing low.

Effective dose versus incremental efficacy and safety risks I guess, what would the impact of only having a 15 milligram versus the 15 and 30 milligram approval half on your view on the atopic derm opportunity, which I think you've talked about is about a $2 billion sales potential previously and then my second question was just a little bit more color on this.

Unknown Speaker: And with a 15 milligram dose, for example, we saw a statistically significant and clinically significant reduction in itch after only two days, which is really quite remarkable in the And again, that's really one of the most bothersome symptoms to patients. So we think we could be successful with either dose, to answer your question specifically. But we also remain confident in the benefit-risk of both. So Chris, this is Rick, I'll cover the aesthetics one for you. As Mike said, I think if you look at the underlying performance of the aesthetics business, in particular, market growth in the US and in China, it's driving the fundamental growth that we see through the. Certainly, there is some impact still from COVID.

So the dynamics I guess is there anything we're seeing with the results. We're seeing very very strong here is there any catch up type event as the world Reopens that we're seeing with these results or are these kind of sustainable underlying trends that are kind of coming in above expectations for that business trying to get a sense of just how to think about that progressing as we go through the rest of the year. Thanks, so much.

So thanks, Chris This is Mike I'll take the first question and then Rick will take the second question that you asked with respect to <unk>, we feel very confident in the benefit risk profile across indications and across the doses that we've study having said that both of 15 and 30 milligram doses have performed very.

Unknown Speaker: So we're seeing some impact there, but I think the majority of it is that when we took over Allergan, we made a decision to really invest in promotion at a much higher level than they had been investing in it prior. And they had an approach that was more of an episodic investment approach where we...

Well, both from an efficacy and a safety perspective.

Unknown Speaker: We have basically made a decision that we'll fund it across the entire year at a relatively low cost.

And so if you look at the efficacy results that we drove with 15 in atopic dermatitis. We drove high levels of response very rapid response and had a very prominent impact on itch, which is one of the most bothersome symptoms with 15 as well as with <unk> and with the 15 milligram dose for example, we saw.

Unknown Speaker: [inaudible]

Unknown Speaker: at this point, the virus is COVID-driven in the U.S.

Unknown Speaker: China continues to grow very well. In fact, I'd say China is back to its level of growth. And we expanded the sales force in China once, about four or five months ago.

Unknown Speaker: continue to drive significant growth going forward.

Unknown Speaker: One area that is still being impacted in a fairly significant way by COVID is

Statistically significant and clinically significant reduction in H. After only two days, which is really quite remarkable in this disease and again, that's really one of the most bothersome symptoms to patients. So we think we can be successful with either dose to answer your question specifically, but we also remain confident in the benefit risk of both doses.

Unknown Speaker: [inaudible]

Unknown Speaker: Brazil as well, we'll hopefully start to see...

Unknown Speaker: [inaudible]

Unknown Speaker: I would tell you I'm very pleased with the decisions we've made around driving more promotion, and I'm pleased with the execution of this team. This team has done extremely well.

Unknown Speaker: This team has done extremely well in executing and driving the kind of share of position that we want and the growth that we want. I think it is sustainable going forward.

So Chris this is Rick I'll cover the aesthetics, one for you as Mike said I think if you look at the underlying performance of these steady business in particular, the market growth in the U S and in China, It's driving the fundamental growth that we see through the business.

Unknown Speaker: Chris. Operator, next question, please.

Unknown Speaker: Yes, our next question comes from Jeffrey Porges with SVB Lyrinc. Your line.

Unknown Speaker: Thank you very much. I have a couple of questions. First, Rick, something we don't talk about a lot, which is the neuroscience portfolio, and you've started reporting it combined. I know there are four products in there, but adding them up, the long-term guidance you provided previously was about $8.3 billion, I think, and you're already annualizing it close to six. So if you were confined to the 15 milligram dose, not because of any signal, but because of the regulators' view of the safety of the class, how much impact would that have on the $8 billion long-term guidance? And do you have other levers that you could pull to fill whatever shortfall that would cause?

Certainly there is some impacts still from.

From COVID-19, so we're seeing some impact there, but I think the majority of it is when we took over.

Allergan, we made a decision to really invest in promotion at a much higher level than they were investing in a prior and they had an approach that was more of an episodic investment approach, where we have basically made a decision that will fund across the entire year are at a relatively significant level to <unk>.

<unk> demand because the data clearly supports that you can grow this market.

I think the best comparisons start to look at what it looked like versus 2019, because you obviously have the COVID-19 impact in 2020.

But you take for example, botox botox versus 2019 and cosmetic botox versus in 2019 is up about 27%.

The market's growing very robustly some of that is probably COVID-19 driven these are U S numbers I'm describing right now.

Unknown Speaker: And on the neuroscience portfolio, it is an area that we're very excited about. So maybe, maybe Jeff and I will tag team here. But I think when you look at the two major growth franchises, they're being

Some of that is probably COVID-19, driven but I wouldn't say a lot of it at this point as COVID-19 driven in the U S.

China continues to grow very well back in say, China is back to the level of growth and we have expanded the sales force in China once about four or five months ago. We are in the process now of going through a second expansion in China I would expect that China will continue to drive significant growth going forward.

Unknown Speaker: The Migraine Franchise and the Antipsychotic Franchise

Unknown Speaker: Both of those, we think, have significant opportunity to continue to grow. I mean, you're obviously seeing Ubrelvi now perform extremely well in the marketplace. I think Geoff can give you probably a little more color on that.

One area that still is being impacted in a in a fairly significant way from COVID-19 is the European market.

We still see it.

Starting we see it starting to emerge in areas like the U K, but there are other areas in Europe that are still in a lockdown.

Unknown Speaker: And Baylor is continuing to perform very well as well. I think if we are able to achieve one positive study on MDD, I think that will give us significant growth going forward. So this is a franchise that we're excited about. I think it will be a meaningful franchise for us over the long term.

I would expect that Europe, and Brazil, as well will hopefully start to see some recover as we get into the second half of this year and they can start to contribute which would add additional growth to the.

Overall business, but I would tell you I'm very pleased with.

The decisions, we've made around driving more promotion and I am pleased with the execution of this team and this team has done extremely well.

Unknown Speaker: Geoff? Yeah, I think just to reiterate, as I mentioned in my comments, the oral CGRP market is moving very nicely. It's hit, I mentioned, 16% for the quarter, but now on the weeklies it's 17% or above on just the penetration of that segment, and so we see a lot of runway in that segment over our long-range planning. And to Rick's point, remember, we have the big anchor asset with Botox Therapeutic and Migraine on the back end for chronic migraine.

In executing.

Driving the kind of share position that we want and the growth that we want so I think it is sustainable going forward.

Thanks, Chris Operator next question please.

Yes. Our next question comes from Geoffrey Porges with SBB Leerink. Your line is open thank.

Thank you very much I appreciate it a couple of questions.

First Rick something we don't talk about a lot, which is the neuroscience portfolio and you've started reporting it.

I know this for a product in there, but adding them up the long term guidance. You provided previously was about $8 3 billion I think Andrew.

Unknown Speaker: And we have plans in place to expand that upstream also into epicenter. This is actually in some ways non-overlapping because we have a big injector base for Botox, and then we can have the neurologist and primary care base for Toja. And so when you look basically across the waterfront, you know, leading acute, oral, very, very potent and active oral agent in the middle with episodic and then on the back end.

We're already Annualizing at close to six so could you give us a sense of how much upside that.

Folio has given the trends that youre seeing and then sort of on a related question.

I hate to harp on the channel question, but obviously, there's a lot coming to us from this.

This impact might be so.

If you work confined to the 15 milligram dose not because of any signal, but because of the regulators. This view of the safety of the class.

How much impact would that have on the 8 billion long term guidance and do you have other levers that you could pull to fill or whatever shortfall that would cause.

Unknown Speaker: Botox, it's a very nice portfolio for us that will drive sales. And as Rick mentioned, we are, you know, encouraged by the potential for adjunctive MDD, and that segment itself, when we do the market analysis, is about as large an adjunctive MDD segment as bipolar depression. And so this basically has the opportunity for us to really double the potential penetration of our long-range plans. So we're very encouraged by this set of things. And Jeff, this is Rob.

Okay.

The neuroscience portfolio. It is an area that we're very excited about so maybe maybe Jeff and I will tag team here, but I think when you look at the two major growth franchises there.

In the migraine franchise and.

The anti psychotic franchise with Baylor both of those we think have significant opportunity to continue to grow I mean, you're obviously seeing revenue now perform extremely well in the marketplace.

Jeff can give you probably a little more color on that and very low is continuing to perform very well as well.

I think if we are able to achieve.

One positive study on M. D. D. I think that will give us significant growth going forward. So this is a franchise.

Unknown Speaker: I would just add, if you take the pieces we've given in terms of long-term guidance, for Raylar, we've talked about approaching $4 billion with the current approved indications. For Migraine, both through Releve and Itojipan, we've talked about peak potential of greater than a billion for each of those assets. And then we have Duopa, plus we have 951 in the pipeline, that I think can drive significant growth in addition to our early stage pipeline neuroscience. So I do see that as a therapeutic area that will drive long-term growth for the company. [inaudible] You're on the jack. We've obviously evaluated it carefully.

We're excited about I think it will be a meaningful franchise for us over the long term, it's an area, where we continue to look at assets that you could potentially add to it.

And I think it will be a nice growth driver for us Geoff Yes, I think just to reiterate as I mentioned in my comments.

The oral <unk> market is moving very nicely.

It has hit a I mentioned, 16% for the quarter, but now on the weekly is at 17 or above on just the penetration of that segment and so we see a lot of runway in that in that segment over our long range planning certainly the availability of of another oral <unk> in this case for episodic.

Unknown Speaker: the positioning of the product. I think if we look at where we are today, one

Migraine allows us to compete in a in a much larger segment beyond the acute.

Unknown Speaker: We're confident in the high dose that has a good risk-benefit profile, but I would tell you it wouldn't change our guidance going forward. The assumptions that we have made in areas like atopic dermatitis, we believe we can get to those assumptions. Without the high dose, that doesn't mean that we don't want the high dose, but at the end of the day, I would point out that we've had additional data on hepaticytinib or RINVOC across a number of areas since that guidance, including IBD. So we've had the UC data that has come largely since that guidance, and those have exceeded our expectations. And so we remain confident overall in the performance.

And to Rick's point remember, we have the big anchor asset with botox therapeutic and migraine on the backend for chronic migraine and we have plans in place to expand that upstream also into episodic migraine and this is actually in some ways non overlapping because we have a big injector base for Botox and then we can have.

The neurologists and primary care base for <unk>, Japan, and so when you look basically really across the waterfront, leading acute agents oral very very potent and active oral agent in the middle with episodic and then on the backend with Botox, It's a very nice portfolio for <unk>.

Unknown Speaker: Thanks, Jeffrey. Operator, next question, please.

That will drive growth and as Rick mentioned.

We are encouraged on the potential for adjunctive mbd and that segment itself. When we do the market analysis is about as large the adjunctive MDT segment as bipolar depression and so this basically has the opportunity for us to really double the potential penetration over.

Unknown Speaker: Thank you. Our next question comes from Andrew Baum with City. Your Line is open. Many thanks.

Unknown Speaker: Many thanks. A couple of questions, please. There's not much that has been bypassed in an agreement in the US over drug price reform, but there seems to be a lot when it comes to antitrust in relation to the pharmaceutical industry. So perhaps Rick could comment following last night's House Committee on the Judiciary, where there was lots of pointed talk from both sides, focusing firstly on patent tickets, and second on having a presumption of anti-competitive behavior in terms of assessments of large scale, in particular M&A, meaning that it would impact future business development for the industry.

Our long range plan. So we're very encouraged over this set of assets and Jeff. This is Rob I would just add if you take the pieces. We've given in terms of long term guidance for railcar we've talked about approaching $4 billion with the current approved indications for migraine both through relevant atone, Japan, we've talked about peak potential of greater than $1 billion for each of those assets and then we have.

<unk> plus we have 95, one in the pipeline and I think can drive significant growth. In addition to our early stage pipeline neuroscience I do see that as a therapeutic area that will drive long term growth of the company going forward.

Unknown Speaker: So that's the first question. And then the second question, rather more positive, in terms of the JAC, when I look at the consensus, the forecast for RIMBOK is about $6 billion. When you look at the size of the opportunity in RA alone, let alone thoracic arthritis, atopic dermatitis, UC, and the other indications you have, is it conceivable to you, short of this drug being effective or the class being heavily limited or pulled from the market, that $6 billion looks like an incredibly conservative estimate for what the...

Great. Thanks, Andrew.

Jack.

John on the Jack.

We've obviously evaluated carefully.

The positioning of the product I think if we look at where we are today one we're confident in the idose.

That is a good risk benefit profile, but I would tell you it wouldn't change our guidance.

Going forward.

The assumptions that we have made in areas like atopic dermatitis.

Believe we can get to those assumptions without the high dose.

Unknown Speaker: Andrew, this is this is Rick. I mean, I'll obviously comment.

Doesn't mean that we don't want to idose, but at the end of the day I believe we can map, we will maintain the guidance that we have based on that.

Yeah.

The other thing that I would point out is that we've had additional data on <unk> <unk> had a sit nib or invoke across a number of areas since that guidance, including IBD. So ive had the UC data that have come largely since that guidance and those have exceeded our expectations and so we remain confident overall in the performance of Rainbow.

Unknown Speaker: Maybe on your point of view around the antitrust discussion.

Unknown Speaker: You know, clearly, I've accepted the invitation to be able to testify before the committee on May 18th. We certainly feel absolutely comfortable and confident in the

Thanks, John.

Unknown Speaker: The way we operate in this market, this is a highly competitive market where Humira competes and certainly as we look at the patents that were issued for Humira, they went through a rigorous process in order to be issued, they represent true innovation to the product, they were challenged by competitors, just like every competitor has a right to challenge a patent if they don't believe it's valid or appropriate and those patents were challenged and the vast majority of those patents

Thanks, Geoffrey Operator next question please.

Thank you. Our next question comes from Andrew Baum with Citi. Your line is open.

Many thanks, a couple of questions treats theres not much bipartisan agreement is in the USA, but drug price reform, but that seems to be a lot. When it comes to antitrust in relation to the pharmaceutical industry. So perhaps you could comment following last Night's House Committee on the judiciary wet.

There was lots of.

Pointed talk for both sides, focusing firstly on patent tickets.

Second on.

Having a presumption that of anti competitive behavior in terms of.

Unknown Speaker: Unknown Speaker

Assessments of large scale in particular M&A.

Unknown Speaker: Look at our behavior in this market. I think our behavior was absolutely pro-competitive.

It would impact future business development for the industry.

The first question and then the second question.

Unknown Speaker: We have patents that go all the way out to 2034 in that portfolio, and yet we chose to let

Robert will positive in terms of the Jack when I look at consensus at the full cost per win bulk cut of about $6 billion.

Unknown Speaker: I've licensed every single Biosimilar player.

Unknown Speaker: in 2023, literally 11 years before the.

When you look at the size of the opportunity and already low less loan psoriatic arthritis, atopic dermatitis, you see it in the other indications you have.

Unknown Speaker: I feel highly confident in the position that we have taken in this marketplace and that we have operated totally appropriately.

Is it conceivable to you shortly.

<unk> effect could be on the Clos being heavily limited a pull from the market that that 6 billion looks like incredibly conservative estimates for what this drug could take.

Unknown Speaker: And then your next question on Winvoke.

Unknown Speaker: on windbow. Thank you.

Unknown Speaker: I'm sorry, I was thinking about the first one, so can you repeat your question? I will.

Andrew. This is this is Rick I mean, all obviously comment maybe on your point of view around the antitrust discussions.

Clearly I have accepted the invitation to be able to testify to the committee on May 18.

Unknown Speaker: I will. I mean, just finishing on the first, you referenced your future testimony, and I guess it was more general rather than just AbbVie-centric, how it would impact BD and the ability of the industry to operate if pricing couldn't get resolved. But moving on to the second question, so my question was whether consensus forecasts for RIMVOC look unrealistically conservative, given the scale of the opportunities and given, in our way alone, looking at the size of that market, it's a progressive disease, that you don't actually need atopic dermatitis to get in excess of where consensus currently pegs forecasts, which are, when we look, about $6 billion. Andrew, this is Rob

We certainly feel absolutely comfortable and confident in the way we operated in this market is a highly competitive market.

Where humira competes and certainly as we look at the <unk>.

<unk> that were issued for Humira. They went through a rigorous process in order to be issued they represent true innovation to the product.

Were challenged by competitors just like every competitor has a right to challenge the patent that they don't believe it's valid or appropriate and those patents were challenged in the vast majority of those patents.

Survive that challenge.

And what I'd say is when we look at our behavior in this market I think our behavior was absolutely pro competitive we have patents that went all the way out to 2034 and that portfolio and yet we chose to license every single Biosimilar player.

In 2023, literally 11 years before the last patent would have expired. So I feel highly confident in the position that debt. We have taken in this marketplace. We have operated totally appropriately.

Unknown Speaker: I'll start and then I'll hand it over to Geoff. I think we agree with you. We do think consensus is conservative. We've given the 2025 guidance of $8 billion for RINVOC, and we would expect it to grow beyond 2025. When I look at the current consensus, obviously, as you quoted, it's a little bit, just a little bit above $6 billion from the numbers I'm looking at. And when I look at the growth beyond 2025, it's nowhere near what we're expecting.

And then your next question on Rainbow.

Yeah.

I'm, sorry, I was thinking about the first one so can you repeat your question.

I will I mean, you.

Just finishing on the FERC reference your future tax I guess it was more general rather than just abbvie centric, how it would impact BD.

The EBITDA.

The ability of the industry to operate if pricing can't get resolved.

Moving on to the second question. So my question was whether consensus forecast for written book look unrealistically conservative given the scale of the opportunities and given in all ran low looking at the size of that market. It's a progressive disease that you didn't actually need atopic dermatitis to get.

Unknown Speaker: So we feel very good about the opportunity there. I think what we covered with you in December still holds. As we've broken out the contribution by indication, we still feel very good about that. But we would agree that consensus is very conservative right now.

<unk> in excess of where consensus currently pegs forecast, which when we look about $6 billion.

Unknown Speaker: Yeah, thanks, Rob and Geoff, and I agree that these are spectacular assets with incredibly dynamic markets. So we see across the rheumatology markets, the atopic derm market, we see the IBD market, which, with both assets, we think is underappreciated, and even expansions in second and third lines as new assets come in that are really breakthrough assets with higher levels of efficacy. And so we clearly believe that consensus is

Andrew This is Robert I'll start and then I'll hand, it over to Jeff I think we agree with you. We do think consensus conservative we've given that 2025 guidance of $8 billion for <unk> and we would expect it to grow beyond 2025, when I look at the current consensus obviously as you quoted it's a little bit just a little bit above 6 billion from the numbers Im looking at.

<unk>.

And I look at the growth beyond 25, it is nowhere near what we're expecting so we feel very good about the opportunity. There I think what we've covered with you in December still holds as we've broken out the contribution by indication we still feel very good about that but we would agree that consensus is very conservative right now.

Unknown Speaker: And just to comment on Atopic Derm, this is an explosive market. I mean, it is significantly underdeveloped in terms of penetration, though it's gonna grow substantially. And even if you look at conservative assumptions on where we source business, you know, the growth of the second line, that's not to say that we're not gonna be very competitive in frontline. It's a very, very attractive market. Again, I think the performance that we've seen, the clinical performance that we've seen right now, primarily in the induction trials for SCIRIZI and RINVOC, SCIRIZI and CRONES, RINVOC and UC, is very, very encouraging, and so we see that cascading over our We are very, very bullish, agreed.

Yes, Thanks, Robert and as Jeff had and agree. It's these are spectacular assets with incredibly dynamic market. So we see across the rheumatology markets. The atopic derm market, we see the IBD market, which with both assets. We think is underappreciated.

Even expansions in second and third lines as new assets come in that are really breakthrough assets with higher levels of efficacy and so we clearly believe that consensus is conservative here and just a comment on atopic derm. This is this is an explosive market I mean, it is significantly up.

Under developed in terms of in terms of the penetration so it's going to grow substantially and even if you look at conservative assumptions on where we source business. The growth of the second line, that's not to say that we're not going to be very competitive in frontline.

Unknown Speaker: Thank you, Andrew. Operator, next question, please.

A very very attractive space and again I think the performance that we've seen.

Unknown Speaker: Yes, our next question comes from Vamil Divan with Miseo Securities. Your line is open.

Clinical performance that we've seen right now primarily on the induction trials for Sky, Rosie and RIN folks got regime Crohns RIN Vulcan you see is very very encouraging and so we see that cascading over our long range plans that well. So we are very very bullish.

Unknown Speaker: Great. Thanks so much for taking my questions. Maybe a couple if I could on the migraine side.

Unknown Speaker: So first, on your BRELV, you mentioned that the class is doing very well in gaining share. It also looks like, over the last few weeks or so, you've been gaining a little share within the classroom relative to NERTC. So I'm just wondering if you can sort of share your perspective on what you think is driving that. Some of us thought it might be due to pricing and access, but based on our calculations, it looks like your gross to net is actually lower than what it is on the BioAid side.

Agreed that consensus is conservative.

Many thanks.

Thank you Andrew Operator next question please.

Yes. Our next question comes from non now demand with Mizuho Securities. Your line is open.

Okay, great. Thanks, so much for taking my questions I've got a couple if I could on the migraine side. So first on your <unk> you.

You mentioned it looks like the class is doing very well and gaining share. It also looks like over the last few weeks or so and you've been gaining a little share within the class relative to <unk>.

I'm just wondering if you can sort of share your perspective on what you think is driving that some of us thought it might be because of pricing and access but based on our calculation. It looks like your gross to net is actually lower than what it James Trump that BIOLASE zone.

Unknown Speaker: So any perspective would be helpful. And then on TotalJapan, maybe just a little more if you could talk about your kind of go-to-market strategy, assuming approval in September, especially again, given NERTC will likely have an indication for both treatment and prevention. So how do you see, you know, kind of coming in with two separate drugs, could be two copays, could be just a different message relative to your single drug? So just any perspective on how you'll compete with that would be helpful as well. Thank you. Yeah, okay, perfect.

Any perspective would be helpful. And then on towards Japan, maybe just a little more if you could talk to your go to market strategy assuming approval in September.

Especially again, given your tech will likely have an indication for both treatment and prevention sort of how do you see.

Kind of coming in with two separate drugs could be to co pays to complete just a difference our message relative to what youre seeing on trucks, just any perspective on how you will continue.

With that would be helpful as well thank you.

Unknown Speaker: Okay, perfect. It's Geoff.

Yeah, Okay, perfect, it's Jeff and in terms of the acute market as I mentioned the penetration of the overall segment is increasing very very nicely as I highlighted if you look at the mix between.

Unknown Speaker: And in terms of the acute market, as I mentioned, the penetration of the overall segment is increasing very, very nicely, as I highlighted. If you look at the mix between Ubrelvi and Nertec, we have gained a little bit over the last few weeks, but it's very close. I mean, we typically run at 51, 52, 53 percent of the new prescription base. I think you are quite perceptive about the value creation that's taking place there. And I clearly don't have full insight into the BioHaven call through, but we've been quite disciplined. You know, we have over 90 percent commercial access.

<unk> and <unk>.

We have gained a little bit over the last few weeks, but its very close I mean, we typically run at $51 50, 253% of the new prescription basis. I think you are quite perceptive over the value creation, that's taking place there and I clearly don't have.

Full insight into the bio Haven fall through but we've been quite disciplined we have over 90% commercial access. So we're quite comfortable where we are from an overall access perspective, and our team remains quite disciplined in terms of making sure that we both drive the right type of volume with our positioning.

Unknown Speaker: So we're quite comfortable where we are from an overall access perspective, and our team remains quite disciplined in terms of making sure that we both drive the right type of volume with our positioning but also achieve the right type of profitability over time. So we're encouraged by our continued momentum with Hugh Brelby. In terms of AtojaPant, I think what's quite impressive about our program there is just the sheer level of efficacy that we have.

But also the right type of profitability over time. So we're encouraged with our continued momentum with <unk> in terms of a toll Japan I think what <unk>.

Quite impressive about our program. There is just the sheer level of efficacy that we have and I think this is very important in terms of sometimes the narrative over simple or easy versus look how do you think about the best drug for episodic prevention, particularly when you choose an oral so we are at the very very high end of the.

Unknown Speaker: And I think this is very important in terms of sometimes the narrative over simple or easy versus, look, what do you think about the best drug for episodic prevention, particularly when you choose an oral? So we are at the very, very high end of migraine freedom or the days of migraine control with this new asset. And we think that, frankly, you need to take care of the migraine.

Migraine freedom or the days of migraine control with this new asset and we think that frankly, you need to take care of the migraine Anatol, Japan will be very well positioned to do that we also think that we'll have nice synergies. Obviously, we have a fairly significant sales force that is promoting <unk> to both.

Unknown Speaker: And AtojaPant will be very well positioned to do that. We also think that we'll have nice synergies. Obviously, we have a fairly significant sales force that is promoting Ubrelvi to both neurologists and high prescribing general practitioners. And it will fit in very well as we put ToeJapan into that sales fleet. So we're set up well, we think, for our go-to market.

<unk> and then high prescribing general practitioners and it will fit in very well as we put a toll japan into that sales suites. So we're set up well we think for our go to market.

Unknown Speaker: Thanks, Vamil. Operator, next question, please.

Okay. Thank you very much.

Thanks, Rommel operator next question please.

Unknown Speaker: Our next question comes from Tim Anderson with Wolf Research. Your line is open.

Our next question comes from Tim Anderson with Wolfe Research Your line is open.

Unknown Speaker: Thank you. A couple of questions, please.

Thank you a couple of questions places I haven't heard really any drug company.

Unknown Speaker: I haven't really heard any drug company this reporting season talk about future potential austerity measures.

This reporting season talk about future potential austerity measures and ex U S geographies, meaning broad based price cuts.

Unknown Speaker: In XUS geographies, meaning, you know, broad-based price cuts following from the impact of COVID. So as a company, as one of the few companies that've given detailed long-term financial guidance, I'm guessing you have been thinking about this. And I'm wondering how you are currently viewing this in terms of its likelihood, [inaudible]

Following from the impact of COVID-19. So as a company is one of the few companies as Kevin detailed long term financial guidance I'm guessing you have been thinking about this and I'm wondering how you are currently viewing this in terms of its likelihood.

Of occurring and what the magnitude could be and what the timing might be and then second question just on our early stage pipeline asset your TNF steroid antibody drug conjugate I believe you have in house, probably a fair amount of data that the markets havent seen yet.

Unknown Speaker: So, Tim, this is Rick. I'll cover the OUS austerity measures. I mean, certainly, if we go back to 2008, we saw that kind of an impact. So, as we're building out our long-range plan, we have made some assumptions around that. I would expect that we will see some pressure outside the U.S. going forward over the next couple of years, but it's certainly manageable within the expectations that we have built for the business going forward, based on that.

I'm wondering when we might see additional human data and what your current level of enthusiasm is towards that platform.

So Tim this is Rick I'll cover the O U S. Austerity measures I mean, certainly if we go back to 2008.

We saw that kind of an impact so as we're building out our long range plan. We have made some sets of assumptions around that I would expect that we will see some pressure.

Did the U S going forward.

Over the next couple of years, it's certainly manageable within the within the expectations that we have built for the business going forward.

Unknown Speaker: Certainly, based on that level of experience that we've seen historically, it's manageable. So it is something that we have contemplated, and I would frankly expect to see some level of pressure going forward.

Certainly based on that level of experience that we've seen historically.

Manageable so.

It is something that we have contemplated and I would.

We expect to see some level of pressure going forward.

So this is Mike I'll take the second question with respect to the TNF steroid conjugate program.

Unknown Speaker: With respect to the TNF steroid conjugate program, we're obviously advancing ABVV154. We have a large Phase IIb RA study that will start this quarter, and then we're starting studies in additional immune-mediated conditions as well over the course of the year. With respect to publication of the data from 3373, which is the closely related compound from the same platform that we received top-line results some time ago, I think you can expect to see more detailed data over the course of the summer.

<unk>, obviously advancing ABV one four we have a large phase <unk> study that will start this quarter and then we are starting studies in additional immune mediated conditions as well over the course of the year with respect to publication of the of the data.

From three $3 73, which is the closely related.

Compound from the same platform that we are top line results sometime ago. I think you can expect to see more detailed data over the course of the summer.

Unknown Speaker: Thanks, Tim. Operator, next question, please.

Thanks, Tim Operator next question please.

Unknown Speaker: Thank you. Our next question comes from Steve Scala with Cohen. Your line is open.

Thank you. Our next question comes from Steve Scala with Cowen Your line is open.

Unknown Speaker: Many thanks. First, on RINVOKE, I'm curious what additional safety data has FDA been provided that it did not have previously? And has all of it been previously presented? And if not, what was the conclusion of what has now been submitted?

Many thanks first on RIN book I'm curious what additional safety data has FDA been provided that it did not have previously and has all of its been previously presented and if not what was the conclusion of what now has been submitted so that's the first question and secondly regarding improved.

Unknown Speaker: So that's the first question. And secondly, regarding Imbruvica, to what extent can AbbVie tease out COVID's impact on new patient starts versus competition from new frontline agents? Thank you. This is Mike. I'll take the first question, and then Rick will handle the second.

To what extent can have the piece out COVID-19 impact on new patient starts versus competition from new frontline agents. Thank you.

So this is Mike I'll take the first question and then Rick will handle the second with respect to <unk>. The additional safety data that were presented to the FDA or provided to the FDA or essentially a roll forward of the analysis that we did at the time of the NDA submission, obviously our database <unk>.

Unknown Speaker: With respect to RINVOC, the additional safety data that were presented to the FDA or provided to the FDA are essentially a roll forward of the analysis that we did at the time of the NDA submission. Obviously, our database continues to grow, we accumulate patient years of experience, and so there weren't...

<unk> to grow we accumulate patient years experienced and so there werent.

Unknown Speaker: Fundamentally new analyses, but we did an updated assessment with the additional data that have accrued in the time between submission and when we submitted it, and what I would say is the data that we reviewed have not changed our impression of benefit-risk in any way. I think they're very consistent with all of the data that have been publicly presented. However, obviously, since they represent data that were current up to the time that we submitted just a few weeks ago, not all of these data have been presented in the public domain. But I would say that our response is very consistent with what we have described.

Fundamentally new analysis, but we did add an updated assessment with the additional data that have accrued in the time between submission and when we submitted those responses and what I would say is the data that we reviewed have not changed our impression of benefit risk in any way I think they are very <unk>.

Consistent with all of the data that have been publicly presented obviously since they represent data that we're current up to the time that we submitted just a few weeks ago not all of these data have been presented in the public domain, but I would say that our response is very consistent with what we have described publicly in the past.

On your second question this is Rick.

We get data on new patient starts so we have relatively.

I think accurate data.

Unknown Speaker: And on your second question, this is Rick. We get data on new patients starved. So we have...

Offset by a couple of months I'll have Jeff maybe talk about a little more detail. So we know any CLO patients when they start regardless of therapy, we can measure that and obviously, we can measure again.

Unknown Speaker: Steve Scala, Chris Schott, Geoff Meacham, Timothy Anderson, Jeffrey Holford, Christopher [inaudible] pretty good. It's all set by a few months. Maybe Jeff. I'm off. That's it. Yeah, so Steve, it's Jeff.

A therapy they start on so I think the level of data integrity that we operate with.

From a market standpoint.

It's pretty good it's offset by a few months, maybe Jeff can speak to the time offset that.

Yes, so Steve it's Jeff So we have pretty good visibility to what what's happening from the share perspective versus the market start perspective, I'll give you some flavor with regard to <unk>.

Unknown Speaker: So we can we have pretty good visibility to what's happening from the share perspective versus the market start perspective. I'll give you some flavor with regard to CalQuint. You know, we can see the impact of the approvals in the front and second line CLL, and it's largely consistent with what our expectations were. So they're ramping up in a similar fashion to what we saw in the MCL or NHL. So we know that there's some impact on Imbruvica there. The largest impact has been, unfortunately, on the market. And unfortunately, I mean, for the patient.

We can see the impact of the approvals in the front and second line <unk> and it's largely consistent with what our expectations were so theyre ramping in a similar fashion to what we saw in the mcl or NHL. So we know that there is some impact on an unimproved because they're the largest impact has been unfortunately into the <unk>.

Market and unfortunately, I mean for the patient so I'll give you a little bit of the numbers. So typically the CLO market, which is the largest driver. It grows sort of at a population level like 2% every year. If you look at the impact from COVID-19, we can see almost three different ways. We can see a wave where the new patient starts in the market were down.

Unknown Speaker: So I'll give you a little bit of the numbers. So typically, the CLL market, which is the largest driver, grows sort of at a population level, like 2% every year. If you look at the impact of COVID, we can see almost three different ways; we can see a wave where a new patient starts on the market; we're down in the high teens in the first part, okay, then it started to claw back a little bit into the single digits.

In the high teens in the first part. Okay. Then it started to claw back a little bit into the single digits down and then it got hit again into the into the teens in the August period, and we saw it down again in early January about 18%. So we can see what's happening and as I mentioned in my remark.

Unknown Speaker: And then it got hit again into the teens in the August period, and we saw it down again in early January, about 18%. So we can see what's happening, and as I mentioned in my remarks, the biggest, the biggest impact here has been continued market suppression. And Steve, this is Rob. I would just remind you also in the first quarter that we had the stocking impact from COVID last year. So if you adjust for that, it's about a four point impact on Imbruvica's growth year over year due to the prior year comp with the stocking impact. Thank you.

Remarks, the biggest the biggest impact here has been on continued market suppression due to COVID-19 and Steve. This is Rob I would just remind you also in the first quarter that we had the stocking impact from COVID-19 last year. So if you if you adjust for that it's about a four point impact on improved because growth year over year due to the prior year comp with the stocking impact.

Unknown Speaker: Thanks, Steve. Operator, next question, please. Yes, thank you.

Thank you.

Thanks, Steve Operator next question. Please yes.

Unknown Speaker: Our next question comes from David Risinger with Morgan Stanley. Your line is open.

Yes. Thank you.

Our next question comes from David Risinger with Morgan Stanley. Your line is open.

Unknown Speaker: Yes, thanks very much. And congrats on the results and updates. I have two questions.

Yes, thanks, very much and congrats on the results and updates I have two questions first just to follow on on that comment could you just help us understand a little bit more about why <unk> is such an outlier in the cancer market why the pandemic is hitting him.

Unknown Speaker: First, just to follow on from that comment, could you just help us understand a little bit more about why Imbruvica is such an outlier in the cancer market? Why is the pandemic hitting Imbruvica very hard, whereas the pandemic is not hitting other cancer agents so hard? And then second, with respect to aesthetics, it's obviously booming, and it is validating your acquisition of Allergan. But I think that you updated guidance for the year for Botox cosmetic to one point nine billion. And that implies a lot. Thank you. This is Mike.

<unk> very hard whereas the.

The pandemic is not hitting other cancer agents, so hard and then second.

With respect to ask Fedex, it's obviously booming and.

It is validating your acquisition of Allergan.

But I think that you updated guidance for the year for Botox cosmetic to $1 9 billion and that implies flat sequential sales from the 477 million net you booked in the first quarter. So if you could explain that please thank you.

Unknown Speaker: I'll take the first question and then others will comment on your second question. With respect to why Imbruvica is being hit harder than other anti-cancer agents in the pandemic, I think it has to do with the underlying rate of progression of CLI. So CLL, while it is a very significant limiter of long-term function and survival. In the short term, there's a sense that therapy can be delayed if necessary because the rate of progression is relatively slower than other forms of therapy, for example, certainly much slower than AML, another indication that we are very active.

So this is Mike I'll take the first question and then others will comment on your second question with respect to why <unk> is being hit harder.

Then other anticancer agents in the pandemic I think it has to do with the underlying rate of progression of CLO.

<unk>, while it is.

A very significant limiter of long term function and survival in the short term there is a sense that therapy can be delayed if necessary because the rate of progression is relatively slower than other forms of cancer. For example, certainly much slower than AML. Another indication that we are very active in.

Unknown Speaker: And so I think in the setting of the pandemic, that's why you are seeing more deferrals for startup therapy, and in some cases, longer times to switch up therapy, which would explain why Rubica dynamics is different than other anti-cancer agents that treat other, David, this is Rob. On your question regarding Botox Cosmetic.

In the in the Haemonchus space and so I think in the in the setting of the pandemic. That's why you are seeing more deferrals for startup therapy.

And in some cases longer time to switch of therapy, which would explain why in <unk>.

Dynamics are different than other anti cancer agents to treat other diseases.

And David This is Rob on your question regarding Botox cosmetic.

Unknown Speaker: So we did see in the first quarter, if you just look at the toxins market growth, it's over 30% in the first quarter; there is some impact from pent-up demand as you come out of the pandemic. But we feel very good about the long-term forecast we put forward, and we obviously took it up by 100 million to essentially pass through the beat in the quarter. I'd say your math on flat to quench is up a little bit. But really, if you consider that we did have some level of pent-up demand come through in the quarter, you have to back that out to really understand the underlying demand dynamics.

Did see in the first quarter. If you just look at toxins market growth, it's over 30% in the first quarter. There is some impact from pent up demand as we come out of the pandemic, but we feel very good about the long the forecast we put forward. We obviously took it up a $100 million essentially pass through the beat in the quarter I would say your math on flat sequential I think it's up a little bit but really.

If you consider that we did have some level of pent up demand coming through in the quarter you got to back that out to really understand the underlying demand dynamics.

Thank you thanks.

Unknown Speaker: Thanks, David. Operator, next question, please.

Thanks, David Operator next question please.

Unknown Speaker: Yes, our next question comes from Ronnie Gao with Bernstein. Your line is open.

And your next question comes from Ronny Gal with Bernstein. Your line is open.

Hi, everybody congratulations on a very nice quarter and thank you for fitting me in.

Unknown Speaker: Hi everybody, congratulations on a very nice quarter and thank you for fitting me in.

Two questions if I may.

There was a data presented from Brexit or about negative symptom improvement using Brian I was wondering what is your take on the data in terms of your ability to use it in the United States is this something that you're considering doing a trial on could this potentially be added to the label and so forth.

Unknown Speaker: I was wondering what your take on the data in terms of your ability to use it in the United States. Is it something that you're considering doing a trial on?

Unknown Speaker: Could this potentially be added to the label, and so forth? And second, the growth in Botox neurology is really impressive. It seems relatively odd that there was such a big jump in the middle of a wave of the epidemic in January and February for a physician-administered product. Can you just give us the flavor of what the underlining trends are there? There's just a lot more success that you're having pushing patients who failed at CGRP into Botox. How should we think about that?

And second I was yeah the growth in Botox neurology is really impressive.

Seems relatively odd that there was such a big jump in the middle.

A wave of the epidemic in January February for a physician administered product could you just give us a flavor of what the underlying trends. There. They are just a lot more success that youre, having in pushing price patients who fail that sit in your opinion to into botox, how should we think about this.

Unknown Speaker: This is Mike. I'll take the first question, and then others will comment on your second question. With respect to negative symptoms and the treatment of those negative symptoms in schizophrenia, it's a very challenging area. It's a very important area because they're responsible for much of the long-term loss of function in patients who suffer from schizophrenia. It has been a very difficult area to approach in general, and we believe Braylor has a good profile there and has a good overall impact on the disease, a very strong overall impact on the disease.

So this is Mike I'll take the first question and then others will comment on your second question with respect to negative symptoms and the treatment of those negative symptoms in schizophrenia. Its a very challenging area. It's very important area because they're responsible for much of.

The long term loss of function in patients who suffer from schizophrenia. It has been a very difficult area to approach in general and we believe <unk> has a good profile there and has a good overall impact on the disease very strong overall impact on the disease, but it's also one that's been very challenging from a labeling perspective in the U S. It's been a very difficult.

Unknown Speaker: But it's also one that's been very challenging from a labeling perspective in the U.S. It's been a very difficult claim to get across in the U.S. So it's not clear that there is a specific path to negative symptoms in the label, but I do think the overall profile of Braylor in schizophrenia, both with respect to symptom control and benefit-risk, is viewed very positively by treating physicians, and I think the overall benefits are well understood by treating physicians, and I think that is reflected in Braylor's overall strength.

Claim to get in the U S. So it's not clear that there is a specific path to negative symptoms.

In the label, but I do think the overall profile of railcar in schizophrenia, both with respect to symptom control and benefit risk are viewed.

Very positively by treating physicians and I think the overall benefits are well understood by treating physicians and I think that.

As reflected in very large overall strong performance.

Unknown Speaker: And it's Jeff. Regarding Botox, it's insightful because we are seeing some robust activity, particularly in migraine, and I think there are a couple reasons for that. You know, one, Rick highlighted the Salesforce dynamics in China. We've definitely focused our sales team, you know, on the migraine component. And the other thing that's taken place is a little bit, I think, of an investment approach. We've had more consistent consumer investment. Since we had the integration then previously, the Legacy Allergan, so I think the combination of consumer investment, new ways where if patients access an injector or neurologist, they can get a sample of Botox right at their first appointment rather than wait for many months. There are various commercial reasons, we think, that give us a lot of encouragement about the therapeutic Botox performance, again, specifically and particularly in migraines.

Yes.

And it's Jeff in regard to Botox, it's insightful because we are seeing some robust activity, particularly in migraine.

And I think Theres, a couple of reasons for that.

One Rick highlighted the sales force dynamics in China, we definitely focused our sales team.

On the on the migraine.

Component and the other thing Thats taken place is a little bit I think of it as an investment approach we'd have more consistent consumer investment.

We had the integration than previously the legacy Allergan. So I think the combination of the consumer investment new ways, where if patients access a injector neurologists. They can get a sample of botox right at their first first appointment rather than wait for many months there are various commercial.

Shall reasons, we think that gives us a lot of encouragement on the therapeutic botox performance again, specifically and particularly in migraine.

Unknown Speaker: Thanks, Ronnie. Operator, next question, please.

Thank you.

Thanks, Ronny operator next question please.

Unknown Speaker: Our next question comes from Terence Flynn with Goldman Sachs. Your line is open.

Our next question comes from Terence Flynn with Goldman Sachs. Your line is open.

Unknown Speaker: Great. Thanks for taking the question. Maybe two for me.

Great. Thanks for taking the question maybe two for me I recognize there is still a lot of unknowns here, but how are you thinking about the potential headwind from any changes to corporate tax rates and guilty.

Unknown Speaker: I recognize there's still a lot of unknowns here, but how are you thinking about the potential headwinds for many changes to corporate tax rates and GILTI? And then, given the progress you outlined on debt paydown, you'll be back to about a two times leverage ratio you mentioned. How are you thinking about capital allocation into the end of this year and into 2022? What types of assets are you focused on for BD and M&A?

And then given the progress you outlined on debt Paydown.

You'll be back to about a two times leverage ratio you mentioned how.

How are you thinking about capital allocation into the end of this year and into 2022, what types of assets are you focused on for BD and M&A. Thank you.

Unknown Speaker: Thank you. So this is Rick. I'll cover the tax.

So this is Eric I'll cover the tax I mean, as you said, it's certainly early in the process and we obviously know what's being proposed but we don't necessarily know where we will end up I think one of the important things that.

Unknown Speaker: I mean, as you said, it's certainly early in the

Unknown Speaker: [inaudible]

Unknown Speaker: to make sure that two things happened. One, that U.S.-based companies were competitive with their foreign competitors. And two, it encouraged companies like ours to invest in the United States. And I can certainly talk about the AbbVie example. I mean, I think it's pretty compelling when you sit back and look at how we were able to go out and acquire an Irish company, re-domicile it back to the United States. You know, AbbVie today has 24,000 jobs in the United States. We've also increased investment significantly in the U.S. since tax. Over the last three years, we've been... [inaudible] That was clearly demonstrated, but we also have the

<unk>.

We need to continue to think through it.

If we go back to one of the reasons why back in 2017 tax reform was passed it was to make sure that two things happen one that U S based companies where competitive for their foreign competitors and to encourage companies like ours to invest in the United States.

Can certainly talk about the Abbvie example.

It's pretty compelling when you sit back and look at we were able to go out and acquire an Irish company re domicile of back to the United States Abbvie.

Abbvie today is 24000 jobs in the United States.

We've also increased investments significantly in the U S since tax reform.

Over the last three years, we've invested.

1 billion $5, we committed that we would do two $5 billion over time revenue exceed that commitment.

Unknown Speaker: They invested much more aggressively. So I think going forward, one of the things that's important

We've added about 500 jobs over that period of time, so companies like ours, clearly took the benefit of tax reform and that has allowed us to be able to be more competitive.

Unknown Speaker: [inaudible]

Unknown Speaker: The current proposal would make the U.S. have the highest rate of all developed countries you'd want to be in. So hopefully, as we go forward, there'll be a balance that's looked at in raising taxes but also making companies maintain a competitive position.

Certainly in the acquisition of a company like Allergan I think that was clearly demonstrated but we also have invested much more aggressively in the U S. So I think going forward one of the things that's important.

For policymakers to balance is to make sure that we don't go back to where we were and that is where U S companies aren't as competitive against their foreign competitors. The current proposal would make the U S had the highest rate of all developed countries I'm not sure. That's the position you would want to be in so hopefully as we go forward there'll be a balance.

Unknown Speaker: and continue to be incented to invest in the U.S. Terence, this is Robin. Your question regarding cap allocation; I'll start, and then Mike will add more color in terms of BD.

Unknown Speaker: We've said all along that as we continue, we will continue to delever through 2023. So, you know, think about that net leverage ratio getting to two times in 2022. I think our balance sheet would be in very good shape, but we want to continue to pay down the debt through 2023. During that period, we've allocated $2 billion of capital for business development. You've seen us do some very nice deals; whether you look at GenMap or IMAP, we've done a number of nice transactions in this space with that amount of capital. But I'll let Mike speak about future opportunities.

<unk> looked at.

And raising taxes, but also making companies maintain and competitive position.

And continue to be incentive to invest in the U S.

Eric This is Robin your question regarding capital allocation I'll start then Michael add more color in terms of BD.

We've said all along is we continue we will continue to delever through 2023, so think about debt net leverage ratio getting to two times in 2002, and your balance sheet had been very good shape, but we want to continue to pay down the debt through 'twenty three during that period, we've allocated $2 billion of capital for business development, you've seen us do some very nice deals whether it's you look at Genmab.

Average number of nice transactions in this space with that amount of capital, but I'll, let Mike speak to future opportunities as well.

Unknown Speaker: In terms of areas in which we would expect to be active between now and the end of 2022, we'll continue to be active in oncology, both in hematological oncology and in solid tumors. That has been an area of focus for us, and I see that continuing to be an area of focus. We would certainly like to add to the aesthetics franchise. We've talked about how we will invest in and continue to drive that franchise, and from a business development perspective, I think there are a number of opportunities there that could present themselves in that timeframe. And there are other areas that, opportunistically, we would certainly like to add to. I would point to neuroscience, if we could find the right opportunities, and eye care as additional areas where we could do that.

In terms of the areas in which we would expect to be active between now and the end of 2022.

Continue to be active in oncology.

In Hematological oncology and in solid tumors that has been an area of focus for us and I see that continuing as an area of focus we would certainly like to add to the aesthetics franchise. We've talked about how we will invest and continue to drive that franchise and from a business development perspective, I think they are.

There are a number of opportunities there that could present themselves in that timeframe and there are other areas that opportunistically, we would certainly like to add too I would point to neuroscience, if we could find the right opportunities.

In eyecare as additional areas, where we could be investing.

Unknown Speaker: Thanks, Terence. Operator, next question, please. Yes, our next question comes from Daniel Busby.

Thanks, Terence operator next question please.

Our next question comes from Daniel <unk> with RBC capital markets. Your line is open.

Unknown Speaker: Yes, our next question comes from Daniel Busby with RBC Capital Markets. Your line is open. Hi, good morning.

Hi, good morning, I'd like to ask a follow up on aesthetics and your high single digit annual growth target for that business over the next decade broadly speaking how much of that growth is dependent on bringing new products to market such as long and short acting toxins versus driving continued growth from these thugs portfolio that you have today.

Unknown Speaker: , , , , , , , , , , , , , , , , This is Rick, I'll cover that and maybe Rob can... Tag team along here.

Unknown Speaker: I think if you look at our overall estimate of high single-digit growth...

Unknown Speaker: [inaudible] market and continue to maintain our share position in that market, and that will allow us to be able to drive that level of growth or higher.

And second as we near the one year anniversary of your acquisition of Allergan can you provide updated thoughts on your appetite for potential divestitures of non core products or therapeutic areas now that you've had about a year to digest that transaction. Thank you.

Unknown Speaker: Yeah, this is Rob. I would just add that if you look at the...

Unknown Speaker: We'll see significant growth, not just from toxins and fillers, but also in body contouring. So as we think about the potential for that leg of the stool, you know, we think we've got really three key drivers of growth within aesthetics that will help us get to that high single-digit long-term expectation. And again, as Rick mentioned, we're not counting on a significant contribution from the pipeline, although we will continue to drive innovation, particularly with toxins and fillers.

This is Rick I'll cover that and maybe.

King.

<unk> came along here I think if you look at our overall estimate of high single digit growth on a steady it's not heavily reliant on a large number of new products, there will be new products that come in they are probably closer towards the back end of the long range plan.

So they don't have they don't have a significant impact on that overall growth rate. So I think we fundamentally believe that the market dynamics are such and the brands are our competitive.

Really competitive in this market that we have the ability to grow the market and continue to maintain our share position in that market and that will allow us to be able to drive that level of growth or higher.

Unknown Speaker: And of course, as you've heard before, it's important within body contouring to continue to drive innovation there as well. So we feel very good about that outlook, and we're not counting on a ton from the pipeline.

Yes. This is Robert I'll, just add that if you look at the aesthetics business and we will see significant growth not just from toxins and fillers, but also in body contouring. So as we think about the potential for that leg of the stool. We think we've got really three key drivers of growth within within aesthetics that will help us get to that high single digit long term expectation and again, it's Rick.

Unknown Speaker: And then your second question, I would say, even before the Allergan acquisition, we constantly looked at our portfolio and determined whether or not there were areas of our business that we ultimately thought we were interested in divesting. I'd say that's a process that we go through on a fairly consistent basis to ensure that we're maximizing the value of the assets that we have within our portfolio. And so, you know, we will continue to do that. And when we find opportunities where we think that's the right strategy, then we'll implement it.

Mentioned, we're not counting on significant contribution from the pipeline, although we will continue to drive innovation, particularly with toxins and fillers and of course.

As you've heard before it's important within body contouring to continue to drive innovation, there as well. So we feel very good about that outlook and we're not counting on a ton from the pipeline there.

And then the second question I would say even before the Allergan acquisition, we constantly looked at our portfolio.

And determined whether or not there were areas of our business that we ultimately thought we were interested in divesting I'd say, that's a process that we go through.

On a fairly consistent basis to ensure that we're maximizing the value of the assets that we have within our portfolio and so.

Unknown Speaker: Thanks, Daniel. Operator, next question, please.

No.

We'll continue to do that and when we find opportunities where we think.

That's the right strategy, and we will execute against that strategy.

Unknown Speaker: Yes, our next question comes from Gary Nachman with BMO Capital Markets. Your line is open.

Thanks, Daniel Operator next question please.

Our next question comes from Gary Nachman with BMO capital markets. Your line is open.

Unknown Speaker: Thanks. A couple more questions on RINVOC. Are you hearing anecdotally from any physicians that may be switching patients from Zelgen to RINVOC in RA if there's a perceived safety benefit with RINVOC as a more selective jack? Are you able to take advantage of that at all?

Thanks, a couple more for me on Rainbow.

Are you hearing anecdotally any physicians that may be switching patients from xeljanz or invoke NRA, if theres a perceived safety benefit with <unk>.

We're selective JAK or you're able to take advantage of that at all.

Unknown Speaker: And then secondly, if Renvo gets approved for Atopic Derm, how will you look to build out your presence with dermatologists? Will you leverage your current footprint on the aesthetic side, or will you have a completely different medical derm team? So just talk about how you're going to pursue that opportunity and how you're preparing for it given your clear level of excitement there. Thank you. Yeah, hi, it's Jeff, and I'll take both of those.

And then secondly, if <unk> gets approved for atopic Derm, how would you look to build out your presence with dermatologists. When you leverage your current footprint on the aesthetic side or whether you have a completely different medical derm team. So just talk about how you go after that opportunity and how you are preparing for it given your clear level of excitement.

And then there thank you.

Yes, Hi, it's Jeff and I'll take both of those so we are we're actually not hearing.

Unknown Speaker: So we aren't actually hearing physicians, you know, from our intelligence from our field teams actively thinking to switch patients from Xeljanz to RINVOC. I mean, that's a big decision for a physician. What we have heard is when we do some of our research and listen to the ground, we clearly see that oral surveillance is perceived as a Xeljanz issue. So typically, what will happen is you may see people take their foot off the gas on some new starts, but we don't see or hear, certainly, any widespread news of active switching. So that's basically our intelligence on your first.

Physicians.

From our intelligence from our field teams actively.

Thinking to switch patients from Xeljanz to RIN book, I mean, that's a big decision for a physician.

While we have heard is when we do some are of our research and our ear to the ground. We clearly see that oral oral surveillance is perceived as a xeljanz issue. So typically what will happen is you may see people take their foot off the gas on some new starts, but we don't we don't see or hear.

Certainly any widespread news of active switching so that's basically our intelligence on your first question.

Unknown Speaker: In terms of your second question, we will not be using the aesthetic sales force. We will basically leverage our existing infrastructure that we have with some expansion that we've taken place for RINVOC and atopic dermatitis. I think, as you know, our reputation amongst medical derms is extremely strong. We have the number one reputation because of the years of Humira and psoriasis and psoriatic arthritis and HS, and obviously, we have a very, very strong impression and launch from Skyrizzy.

In terms of your second question.

We will not be using the aesthetic sales force, we will basically leverage our existing infrastructure that we have with some expansion that we've taken place for <unk> in atopic dermatitis I think as you know that in terms of our our reputation amongst the medical derm is extremely strong.

We have the number one reputation because of the years of Humira in psoriasis and Psoriatic arthritis in Hs and obviously, we have a very very strong impression and launch from sky risky. So we basically designed a sales force that through our management, which has been connected to these terms for more than <unk>.

Unknown Speaker: So we basically designed a sales force that, through our management, which has been connected to these derms for more than a decade and existing reps with some new reps in there, we are building, we have built a sales force that will work seamlessly with our Skyrizzy teams to give a very nice offering to those dermatologists. An important fact is that basically the overlap of those dermatologists that drive the atopic derm market is about 90% between the atopic derm market and the psoriasis market. So we feel we're well positioned in terms of how we have set up our go-to-market approach with this segment.

A decade and existing reps with some new reps in there. We are building we have built a sales force that will work seamlessly with our sky rizzi teams to give a very nice offering to those dermatologists and important fact is that basically the overlap of those dermatologists that drive basic.

The atopic derm market is about 90% between the atopic derm market in the psoriasis market. So we feel we're well positioned in terms of how we set up our go to market approach with this segment.

Unknown Speaker: Thanks, Gary. Operator, next question, please.

Thanks, Gary Operator next question please.

Unknown Speaker: Yes, our next question comes from Greg Gilbert with Truist Securities. Your line is open.

Yes. Our next question comes from Gregg Gilbert with true with Securities. Your line is open.

Unknown Speaker: Thank you, Mike. I was interested in your oral psoriasis commentary. Are you assuming that a new bar has been set by Ducravis-Sitnab in terms of efficacy versus Otesla? And is that something you're very mindful of as you consider your own programs?

Thank you Michael I was interested in your oral psoriasis commentary are you assuming that a new bar has been set baidu kravis sitting up in terms of efficacy versus low Tesla and is that something you're very mindful of as you consider your own programs and secondly for Rick.

Unknown Speaker: And secondly, for Rick, I realize AbbVie was born out of a company that had devices and pharma under one roof, but clearly, in aesthetics, for example, that good franchise building could involve drugs and devices or drugs that need to be delivered by device. Does that apply as you think ahead about ophthalmology or other areas when you consider long-term biotech? Thank you. This is Mike. I'll take the first question.

I realised abbvie was born out of a company that had devices and pharma under one roof, but clearly you've embraced.

Fedex for example that good franchise building could involve drugs and devices or.

Drugs that need to be delivered by device does that apply as you think ahead about ophthalmology or other areas. When you consider long term BD. Thank you.

So this is Michael I'll take the first question with respect to oral psoriasis agents, we would want to come in from an efficacy perspective with something that clearly exceeded the threshold that existed in the past without Tesla and I think coming in.

Unknown Speaker: With respect to oral psoriasis agents, we would want to come in from an efficacy perspective with something that clearly exceeded the threshold that existed in the past with Otesla, and I think coming in in a range that is Humira-like or better would be our goal. I think if you look at, you know, BMS's TIK2, they sort of come in at that Humira-like efficacy. And so I think that is generally the range that we're talking about.

In a in a range that is humira like were better.

It would be our goal I think if you look at.

BMS is TIK two they sort of come in at that Humira like efficacy and so I think that is generally the range that we're talking about I think when when one talks about a direct comparison in terms of where the bar is set we have to look not only at efficacy, but it's safety net that totality of the data obviously is extremely early for for our <unk>.

Unknown Speaker: I think when one talks about, you know, a direct comparison in terms of where the bar is set, we have to look not only at efficacy but at safety and at the totality of the data. Obviously, it's extremely early for our ROR gamma T agent, but we think it is a molecule, because it impacts very well understood biology with a good understanding of where to go from an efficacy perspective and a good understanding of safety, that we can get in a range that's very competitive there. So I think we'd be looking for that Humira-like efficacy or greater as something that we would like to use to enter the space with an oral, obviously coupled with a strong.

Again, the T agent, but we think it is a molecule.

Because it impacts very well understood biology with with a good understanding of where to go from an efficacy perspective and a good understanding of safety that we can get in a range thats very competitive there. So I think we'd be looking for that humira like efficacy.

Or greater as something that we would like to use to enter this space with an oral obviously, coupled with with a strong safety profile.

Unknown Speaker: This is Rick. I think the way we approach the markets that we operate in is we look for areas where there are significant unmet needs, and then we ultimately try to come up with solutions for those needs. Sometimes it's drugs-only. In fact, I'd say that

On your second question. This is Rick I mean, I think the way we approach the markets that we operate in and as we look for areas, where there are significant unmet needs and then we ultimately try to come up with solutions for those needs. Sometimes it's struggling on land that they share the majority of our historical experience as Abbvie has been able to draw the only.

But it is an example of 95 to one is a good example of where it's a combination product <unk> device and as Rod certainly as we look at ophthalmology, we have implantable devices.

Unknown Speaker: is a good example of where it's a combination product, right, a device and a drug.

Unknown Speaker: Certainly, as we look at ophthalmology, we have implantable devices.

Unknown Speaker: that were part of the Allergan acquisition and are important therapeutic options. They're available for physicians and patients.

Part of the Allergan acquisition that are important therapeutic options.

Available for physicians and patients.

Unknown Speaker: So I'd say we...

So I'd say, we tend to go at it and we're certainly not opposed to.

Unknown Speaker: We tend to go at it, and we're certainly not opposed to devices being part of it if they can add to the ability to be able to provide for an advancement in standard of care. In aesthetics, as Rob indicated a moment ago, you know, we're looking at what is that big third leg on the stool, and we believe that is the body. And I would say in the area of the body, devices are going to play a much more critical role.

Two devices being part of it if they can add to the ability to be able to provide for an advancement in the standard of care in aesthetics as as Rob indicated a moment ago. We're looking at what is that big third leg on the stool and we believe that his body.

And I would say in the area of body devices are going to play a much more critical role and so that's an area, where I think youll see us embrace.

Unknown Speaker: because they provide the right solution for that particular improvement.

Even device only kinds of strategies because they provide the right solution for that particular <unk>.

Unknown Speaker: So it's an area that historically, many of us know well because of our experience, as you pointed out in our previous life, but I'd also say the team.

Their improvement.

So it's an area that we historically many of us know well because of our experience as you pointed out.

Unknown Speaker: But I'd also say that the teams in the organization itself tend to look for broad-based solutions that can meet unmet needs.

In our previous life, but I would say also the teams in the organization itself tend to look for broad based solutions that can meet the unmet need.

Unknown Speaker: Thanks, Greg. Operator, we have time for one final question.

Thank you.

Thanks, Gregg operator, we have time for one final question.

Unknown Speaker: Thank you. Our last question comes from Naveen Jacob with UPS. Your line is open.

Thank you our last question comes from Navin Jacob with UBS. Your line is open.

Unknown Speaker: Hi, thanks so much for squeezing me in here. A couple, if I may, if we have time, but just on Braylor, you have strong long-term guidance of $4 billion with just the existing indications, but the script trends at least seem to have slowed down, obviously in part because Nero has been weak as an overall therapeutic area during the pandemic.

Hi, Thanks, so much for.

Squeezing me in here a couple if I may if we have time, but I just wanted to <unk>.

You have the strong long term guidance of $4 billion with just the existing indications but.

The script trends at least.

It seemed to have slowed down obviously in part because narrow has been weak.

Overall therapeutic area during the pandemic, but just wondering just given that the quarter itself was a little bit weaker I think versus expectations can you talk about the broader neuro market.

Unknown Speaker: But just wondering, and just given that the quarter itself was a little bit weaker, I think, versus expectations, can you talk about the broader neural market? Is there weakness there? Because we do see strength in

Is that weakness there because we do see strength with <unk> and with <unk>.

Unknown Speaker: with Ubrella V and with Botox Therapeutics. So I was just wondering if there's something going on specifically.

Botox therapeutics, so just wondering if theres something going on specifically with Brian <unk>.

The bipolar depression opportunity been tapped out for some reason and what what can you. What do you what can you would need to do to accelerate growth for radar with the existing.

Unknown Speaker: Specifically, Braylor has bipolar depression.

Unknown Speaker: [inaudible]

Unknown Speaker: Unknown Executive, Mohit Bansal, Carson Wong, Perry Siatis, Marcella Pinella, AbbVie

Indications, that's number one and number two on RIN book I.

I think everyone understands the rates around DVT P and mace, but if you could give a little bit more clarity on based on the updated data that you filed with the agency what the rate of malignancy is.

Unknown Speaker: across the indications and whether that's any different between the strengths and how that compares to the background rate. Thank you so much. Yeah, hi, it's Jeff.

Across the indications and whether that's.

Any different between the strengths and how that compares to the background rate. Thank you so much.

Unknown Speaker: I'll take the Braylor comment. You know, the macro prescription market has been down a little bit versus historical trends. But we really think it's simply a timing issue, and I'll give you some numbers that support that. So, Before COVID hit, right in the first quarter of last year, the new-to-brand, or the MBRX for Veralar, was about 3,500 new-to-brand prescriptions a week. And what we saw is that during COVID, that dropped down all the way to about 2700. That was the mid-year of 2007.

Yeah, Hi, it's Jeff I'll take the the <unk> comment.

The macro.

Prescription market has been down a little bit versus historical trends.

But we really think it's simply a timing issue and I'll give you some some numbers that support that so.

Before before COVID-19 hit right in the first quarter of last year, the new to brand or the <unk> four per <unk> was about 3500, new to brand prescriptions, a week and what we saw is during COVID-19 that dropped down all the way to about 2700 that was the midyear and.

Unknown Speaker: And then it's consistently come back up. So, towards the end of March, we started to hit or recover that pre-COVID historical rate. So progress is there, and ultimately, the way we see these markets function, as you recover your MBRX momentum, the TRXs will start to come. So we're encouraged by the latest trends, but your point is right. It has been a little bit soft on the market, and certainly, as a brand, Braylor dropped because of COVID, but it's now really fully recovered. And so we should see continued recovery. So hopefully, that will happen. This is Mike.

It's consistently come back up so towards the end of March we started to hit our recover that pre COVID-19 historical rates. So progresses, there and ultimately the way we see these markets functions as you recover your MBR ex momentum that <unk> will start to come. So we're encouraged on the latest trends, but your point.

Is right it has been a little bit soft on the market and certainly as a brand <unk> dropped because of COVID-19, but is now really fully recovered and so we should see continued recovery of the momentum there so hopefully that helps.

So this is Mike I'll take your second question with respect to the rates of malignancies, excluding non melanoma skin cancer because that's the way. These rates are typically are reviewed.

Unknown Speaker: I'll take your second question, regarding the rates of malignancies excluding non-melanoma. That's the way these rates are typically reviewed. I recently described a rate across RINVOC studies with roughly 10,000 patient years of experience of 0.8 events per 100 patient years of experience, and that compared to an expected rate that was 0.9 or higher, depending on the estimate, so we'll call it in the range of about 0.9. So, not different from that expected rate, and without any difference between doses, so no evidence, and nothing that we've seen in recent.

I recently described right across <unk>.

Studies with roughly 10000 patient years of experience of 0.8 events.

Per 100 patient years experienced and that compared to an expected rate that was 0.9 or higher depending on the estimates that we'll call. It in the range of about 0.9 events.

No not different from that expected rate and without any difference between doses. So no evidence of a dose response and nothing that we've seen in the recent work that we've done changes that that view in anyway.

Unknown Speaker: Thanks, Naveen. That concludes today's conference call. If you'd like to listen to a replay of the call, please visit our website at investors.abbvie.com.

Thanks, Lee that concludes today's conference call, if you'd like to listen to a replay of the call. Please visit our website at investors Abbvie Dot com. Thanks again for joining us.

.com. Thanks again for joining us.

Thank you for your participation. Please, participants, you may disconnect at this time.

Yeah.

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