Q3 2021 Abbvie Inc Earnings Call

Good morning.

Operator: Thank you for standing by. Welcome to the AbbVie third quarter 2021 earnings conference call. All participants will be on a listen-only basis until the question and answer portion of the call. You may ask a question by pressing star 1 on your phone. I would now like to introduce Ms. Liz Shea, Vice President of Investor Relations. Ma'am, you may proceed.

Thank you for standing by welcome to the Abbvie third quarter 2021 earnings conference call.

All participants will be on a listen only until the question and answer portion of the call you.

You May ask a question by pressing star one on your phone.

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

Ma'am you May proceed.

Liz Shea: 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 Geoff Stewart, Executive Vice President, Commercial Operations. Before we get started, some of the statements we make today may be considered forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995.

Good morning, and thanks for joining us.

Also on the call with me today are Rick in Dallas, 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 before we get.

Started some statements we make today may be considered forward looking statements for purposes of the private Securities Litigation Reform Act of 1995.

Liz Shea: 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 statement. Additional 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'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.

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 additional 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 abbey'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.

Liz Shea: 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 policies and exclude the divestitures of ZENPEP and Biocased. References to operational growth further exclude the impact of, Following our prepared remarks, we'll take your questions. So with that, I'll now turn the call over to you. Thank you, Liz.

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

Where this comparison of underlying performance all historically reported Allergan revenues have been recast to conform to Abbvie is revenue recognition accounting policies and exclude the divestitures of <unk> and bio case references to operational growth further exclude the impact of exchange.

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

Rick Gonzalez: Good morning, everyone. And thank you for joining us today. I'll discuss our third quarter performance and outlook, and then Geoff, Mike, and Rob will review our business highlights, pipeline progress, and financial results in more detail. AbbVie continues to perform very well. We once again delivered an outstanding quarter with adjusted earnings per share of $3.33, exceeding the midpoint of our guidance by $0.13. Total adjusted net revenues of more than $14.3 billion were up 10.8% on an operational basis, with balanced growth across each of the major growth platforms.

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

Abbvie continues to perform very well, we once again delivered an outstanding quarter with adjusted earnings per share of $3.33 exceeding the midpoint of our guidance by <unk> 13 cents.

Total adjusted net revenues of more than $14 3 billion.

It was up 10, 8% on an operational basis with balanced growth across each of the major growth platforms.

Yes.

Rick Gonzalez: We continue to see double-digit revenue growth in immunology, where Skyrizzy and Renvoke have established very strong launch trajectories. These two assets are either approved under regulatory review or in late-stage development across all of Humira's major indications, and we remain confident that they will both be significant contributors to AbbVie's long-term growth. Aesthetics is also demonstrating impressive double-digit operational sales growth

We continue to see double digit revenue growth in immunology, where sky Ritchie and Randgold have established very strong launch trajectories used.

These two assets are either approved under regulatory review or in late stage development across all of Humira as major indications and we remain confident that they will both be significant contributors to these long term growth.

Our strategy is also demonstrating impressive double digit operational sales growth.

Rick Gonzalez: ,,,,, Our dedicated global aesthetic structure and increased investment are driving accelerated category growth across both toxins and fillers, where there is substantial room for additional market penetration. Our strategic investments and targeted field force expansions have improved overall customer retention rates and significantly increased the number of first-time patients to our leading brand. We are once again raising our full-year guidance for aesthetics this quarter, and we view this portfolio as an extremely attractive growth opportunity over the long term, with high single-digit compounded annual growth rates expected through the end of the decade.

Our dedicated global aesthetic structure and increased investment are driving accelerating category growth across both toxins and pillars, where there is substantial room for additional market penetration.

Our strategic investments and targeted field force expansions have improved overall customer retention rates and significantly increased the number of close time patients to our leading brands.

We are once again, raising our full year guidance for <unk> This quarter and we view. This portfolio is an extremely attractive growth opportunity over the long term with high single digit compounded annual growth rates expected through the end a good decade.

Rick Gonzalez: Our neuroscience business drove robust double-digit revenue performance again this quarter, and we added a compelling new product to our migraine portfolio with the approval of Qlipta, a once-daily oral medication for the preventative treatment of episodic migraines. Our hemozoological oncology portfolio delivered operational sales growth of approximately 8% this quarter, despite a protracted market recovery in CLL, which remains below pre-COVID levels. Beyond the significant contributions of Imbruvica and Venclexta, we have an exciting oncology pipeline with several promising programs in development for blood cancers and solid tumors to support sustainable long-term growth. These include Nabitoclax for myelofibrosis, and Epicritimab for B-cell malignancy. 383 for multiple myeloma, Limsoparlamab for AML and MDS, as well as Talisov for non-squamous, non-small cell lung cancer.

Our neuroscience business drove robust double digit revenue performance again, this quarter and we added a compelling new product to a migraine portfolio with the approval of tulip.

A once daily oral medication for the preventative treatment of episodic migraine.

Our hematological oncology portfolio delivered operational sales growth of approximately 8% this quarter, despite a protracted market recovery and C O L.

Which remains below pre COVID-19 levels.

Beyond the significant contributions of improve again Ben collection.

We have an exciting oncology pipeline with several promising programs in development for blood cancers, and solid tumors to support sustainable long term growth. These include Nevada clacks for myelofibrosis.

Mad for B cell malignancies, ABVD 383 for multiple myeloma, Lemzo Parliament for AML, and Mds as well as police Ob for non squamous non small cell lung cancer.

Rick Gonzalez: Lastly, we continue to make excellent progress with the integration of Allergan. Our financial results show that we have created a stronger and much more diverse company, with numerous products across our newly combined portfolio, delivering robust growth. Overall, I'm extremely pleased with our momentum, and we are once again raising our full year 2021 EPS guidance. We now expect adjusted earnings per share of $12.63 to $12.67, reflecting growth of nearly 20% at the midpoint.

Lastly, we continue to make excellent progress with the integration of Allergan and our financial results show that we have created a stronger and much more diverse company with numerous products across our newly combined portfolio delivering robust growth.

Overall I'm extremely pleased with our momentum and we're once again raising our full year 2021, EPS guidance. We now expect adjusted earnings per share of $12 63 to.

To $12.67, reflecting growth of nearly 20% at the midpoint.

Rick Gonzalez: Additionally, as noted in our news release, today we're announcing an 8.5% increase in our quarterly cash dividend from $1.30 per share to $1.41 per share, beginning with the dividend payable in February 2022. Since our inception, we've grown our quarterly dividend by more than 250%. In summary, we're demonstrating strong execution across our portfolio. We've assembled an impressive set of diversified assets with significant growth potential, giving us a high degree of confidence in the long-term outlook for our business. With that, I'll turn the call over to Jeff.

Additionally, as noted in our news release today, we're announcing an eight 5% increase in our quarterly cash dividend from $1 30 per share to $1 41 per share beginning with the dividend payable in February 2022.

Since our inception, we have grown our quarterly dividend by more than 250%.

In summary, we are demonstrating strong execution across our portfolio. We've assembled an impressive set of diversified assets with significant growth potential, giving us a high degree of confidence in the long term outlook for our business with that I'll turn the call over to Jeff Jeff. Thank you Rick.

Jeffrey Ryan Stewart: Thank you, Rick. We continue to demonstrate strong and balanced growth across our therapeutic portfolio. I'll start with immunology, where we remain well-positioned for sustained leadership with a portfolio of best-in-class medicine. Total immunology revenues were approximately $6.7 billion, up 14.9% on an operational basis. Global Humira sales were more than $5.4 billion, up 5.2% on an operational basis, with 10.1% revenue growth in the U.S., offset by biosimilar competition across the international markets, where revenues were down 16.7% on an operational basis. Guy Rizzi is performing extremely well.

And we continue to demonstrate strong and balanced growth across our therapeutic portfolio.

I'll start with immunology, where we remain well positioned for sustained leadership with a portfolio of best in class medicines.

Total immunology revenues were approximately $6 $7 billion up 14, 9% on an operational basis.

Global Humira sales were more than $5 4 billion up five 2% on an operational basis with 10, 1% revenue growth in the U S offset by Biosimilar competition across the international markets, where revenues were down 16, 7% on an operational basis.

<unk> is performing extremely well global.

Jeffrey Ryan Stewart: Global sales of nearly $800 million were up 18.1% on a sequential basis, reflecting Continued Market Share Gains. In the U.S., Skyrizzy's leading in-play psoriasis patient share, which includes both new and switching patients, is now roughly 36 percent, more than double the share captured by the next nearest biologic competitor. Sky Rizzy's total prescription share in the U.S. psoriasis biologic market is now nearly 20 percent, second only to Humira. Internationally, Sky RISD continues to ramp nicely, having also achieved in-play patient share leadership in more than a dozen key markets.

Global sales of nearly $800 million were up 18, 1% on a sequential basis, reflecting continued market share gains.

In the U S Guy really Sky Ridge. These leading in play psoriasis patient share, which includes both new and switching patients is now roughly 36% more than double the share capture of the next nearest biologic competitor sky.

<unk> total prescription share in the U S. Psoriasis biologic market is now nearly 20% second only to Humira.

Internationally Sky Rajiv continues to ramp nicely, having also achieved in play patient share leadership in more than a dozen key markets.

Jeffrey Ryan Stewart: This compelling share performance will be further supported by two important near-term enhancements, the availability of more simple delivery forms for SCIRIS-E, as well as the potential indication expansion in psoriatic arthritis. First, we recently launched the new and convenient Skyrizzy single-dose, 150-milligram self-injectable pen and syringe in major territories around the world.

This compelling share performance will be further supported by two important near term enhancements the availability of more simple delivery forms for sky rizzi as well as the potential indication expansion in Psoriatic arthritis.

First we recently launched the new and convenient Sky Rizzi single dose 150 milligrams self injectable pennant syringe and major territories around the world. The market response has been very favorable and the approval now make sky Rajiv the only quarterly dose brand that is available in a single <unk>.

Jeffrey Ryan Stewart: The market response has been very favorable, and the approval now makes Skyrizzy the only quarterly dose brand that is available in a single self-injectable pen for patients. Second, we are preparing for the global launch of Skyrizzy in psoriatic arthritis as we near approval decisions in both the U.S. and Europe. We received a CHMP positive opinion earlier this month, with anticipated approval in Europe by year end.

Self injectable pen for patients.

Second we are preparing for the global launch of <unk> in Psoriatic arthritis, as we near approval decisions in both the U S and Europe.

We received a see HMP positive opinion earlier this month with anticipated approval in Europe by year end and we continue to expect FDA approval early next year.

Jeffrey Ryan Stewart: And we continue to expect FDA approval early next year. The addition of this indication, once approved, will round out Skyrizzy's dermatology label and give patients with PSA access to a new, compelling therapeutic option. We are also making excellent progress with Skyrizzy's development in Crohn's disease, which was recently submitted for U.S. regulatory review with commercialization expected next. Renvoke also continues to demonstrate robust growth. Global sales of more than $450 million were up nearly 20% on a sequential basis.

The addition of this indication once approved will round out <unk> dermatology label and give patients with PSA access to a new compelling therapeutic option.

We are also making excellent progress with Sky receipt development in Crohn's disease, which was recently submitted for U S regulatory review with commercialization expected next year.

<unk> also continues to demonstrate robust growth.

Sales of more than $450 million were up nearly 20% on a sequential basis total in play <unk> share remained strong and now reflects approximately 17% patient share in the U S as well as leadership and a half a dozen key countries around the world.

Jeffrey Ryan Stewart: Total in-play RA share remains strong and now reflects approximately 17% patient share in the U.S., as well as leadership in a half-dozen key countries around the world. Internationally, Renvoke Share continues to ramp up in RA, and we are making excellent progress with the recent commercial launches of PSA, AS, and atopic dermatitis, where we have secured strong labels for each of these indications. As many of you are aware, the FDA issued a safety communication regarding new and updated warnings for JAK inhibitors, including RINVOC, in early September.

Internationally, we're invoke share continues to ramp in RA, and we are making excellent progress with the recent commercial launches of PSA.

<unk> and atopic dermatitis, where we have secured strong labels for each of these indications.

As many of you are aware the FDA issued a safety communication regarding new and updated warnings for JAK inhibitors, including <unk> in early September.

Jeffrey Ryan Stewart: While we do not yet have an updated label, we are closely monitoring prescription trends and feedback from the field, and we have not observed a significant impact on Renvoke's utilization at this time. That said, should the updated label restrict use to TNF-inadequate responders, we would certainly expect a near-term impact on new patient starts in RA. Based on the robust data we have generated across our development program against multiple biologics and later lines of RA therapy, we do expect that RINVOC will ultimately obtain higher share growth in the second-line plus setting, as most patients ultimately fail TNF therapies over. Overall, we continue to feel very good about the performance and profile of Renvoke and remain confident this asset will be a major contributor to AbbVie's long-term growth.

While we do not yet have an updated label we are closely monitoring prescription trends and feedback from the field and we have not observed a significant impact to <unk> utilization at this time.

That said should be updated label restrict use the TNF inadequate responders, we would certainly expect a near term impact to new patient starts and raw.

Based on the robust data we've generated across our development program against multiple biologics and later lines of therapy, we do expect that <unk> will ultimately obtain higher share growth in the second line plus setting as most patients ultimately fail TNF therapies over time.

Overall, we continue to feel very good about the performance and profile of <unk> and remain confident this asset will be a major contributor to add these long term growth.

In hematologic oncology global revenues were nearly $1 9 billion up eight 1% on an operational basis in.

<unk> have a strong position across multiple heme indications, including CLO, where add these combined portfolio remains the clear market share leader across all lines of therapy.

Jeffrey Ryan Stewart: In hematologic oncology, global revenues were nearly $1.9 billion, up 8.1% on an operational basis. Ambruvica and Venklexta have a strong position across multiple HEIM indications, including CLL, where AbbVie's combined portfolio remains the clear market share leader across all lines of therapy. Global Imbruvica revenues were approximately $1.4 billion, up 0.3%. In the US, performance continues to be primarily impacted by a slower than expected market recovery in CLL, as well as some modest share erosion from newer therapies, including Venclexta and other BTK inhibitors. New patient starts in CLL remain below pre-COVID levels, and it is difficult to predict when this dynamic may fully recover.

Global <unk> revenues were approximately $1 $4 billion up 0.3% in the U S performance continues to be primarily impacted by a slower than expected market recovery in <unk> as well as some modest share erosion from newer therapies, including <unk> and other <unk> inhibitors.

<unk>.

New patient starts and CLO remain below pre COVID-19 levels and it is difficult to predict when this dynamic may fully recover.

<unk> sales were up 38, 7% on an operational basis with increasing momentum across all indications, including a strong AML launch trajectory and the international markets.

And neuroscience revenues were nearly $1 6 billion up 25% on an operational basis I am, particularly pleased with the results and the outlook for our emerging migraine portfolio, where we are now the only company to have a portfolio of distinctive therapies to address the spectrum of this common comp.

Jeffrey Ryan Stewart: BenClexa sales were up 38.7% on an operational basis, with increasing momentum across all indications, including a strong AML launch trajectory in the international market. In neuroscience, revenues were nearly $1.6 billion, up 25% on an operational basis. I'm particularly pleased with the results and outlook for our Emerging Migraine Portfolio, where we are now the only company to have a portfolio of distinctive therapies to address the spectrum of this common, complex, and debilitating disease, including... Botox Therapeutic, a unique foundational treatment for the prevention of chronic migraine, which is performing very well.

Flex and debilitating disease include.

Including Botox therapeutic a unique foundational treatment for the prevention of chronic migraine, which is performing very well total sales of $645 million for all of the therapeutic botox users were up 22, 5% on an operational basis.

<unk>, our leading oral <unk> treatment for acute migraine is also demonstrating rapid growth total sales of $162 million were up nearly 30% on a sequential basis.

Just on your <unk> competitive profile continued strong new patient starts and a rapidly expanding market. We remain confident that you broadly represents a $1 billion plus peak sales opportunity.

Jeffrey Ryan Stewart: Total sales of $6 hundred and forty five million dollars for all the therapeutic Botox uses were up twenty-two point five percent on an operational basis. Brelby, our leading oral CGRP treatment for acute migraine, is also demonstrating rapid growth. Total sales of $162 million were up nearly 30 percent on a sequential basis.

And now we are just launching to lift up the only oral <unk> specifically developed for the preventative treatment of migraine, which is already off to an excellent start.

Early feedback from our physicians has been very positive given <unk> strong efficacy safety and convenient dosing profile relative to the current standards of care.

Jeffrey Ryan Stewart: Based on Ubrelvi's competitive profile, continued strong new patient starts, and a rapidly expanding market, we remain confident that Ubrelvi represents a $1 billion plus peak sales opportunity. And now we are just launching Qlipta, the only oral CGRP specifically developed for the preventative treatment of migraine, which is already off to an excellent start. Early feedback from our physicians has been very positive, giving Q-LIFT a strong efficacy, safety, and convenient dosing profile relative to the current standards. The Q-LIFT launch is being supported by our existing migraine sales force, with commercial access expected to ramp strongly through the first half of 2022. Tulipta also represents a $1 billion plus peak sales opportunity.

For Q lift the launch is being supported by our existing migraine salesforce with commercial access expected to ramp strongly through the first half of 2022 to lift to also represents a $1 billion plus peak sales opportunity now.

Now, we believe having three distinct and competitively positioned therapies across the spectrum of migraine conditions with botox therapeutic you broadly and COO lifter, which each have been optimized for a specific migraine indication enables physicians to tailor treatment for the broadest range of patients our.

Folio of migraine therapy puts us in a very strong position to capture growth in this dynamic market.

Turning to psychiatry, we also see robust performance with railcar, which remains the fastest growing atypical anti psychotic total revenues of $461 million were up 29% on an operational basis with continued strong demand across schizophrenia bipolar one disorder.

Jeffrey Ryan Stewart: Now we believe having three distinct and competitively positioned therapies across the spectrum of migraine conditions with Botox Therapeutic, Ubrella, and Q-Lypta, which each have been optimized for a specific migraine indication, enables physicians to tailor treatment for the broadest range of patients. Our portfolio of migraine therapy puts us in a very strong position to capture growth in this dynamic market. According to Psychiatry, we also see robust performance with RALAR, which remains the fastest growing atypical antipsychotic. Total revenues of $461 million were up 29% on an operational basis, with continued strong demand across schizophrenia, bipolar 1 disorder, and bipolar depression.

In bipolar depression.

Lastly in our other key therapeutic areas, we saw a significant contribution from eyecare, which had revenues of $871 million.

Up two 9% on an operational basis.

Maverick sales were $426 million up two 9% on an operational basis as treated patient volumes still remain suppressed compared to pre COVID-19 levels.

And we saw double digit growth.

Operationally, both creon and Lupron.

So overall I'm pleased with our continued execution across the therapeutic portfolio, which is demonstrating strong revenue growth and with that I'll turn the call over to Mike for additional comments on our R&D programs, Mike. Thank you Jeff.

I'll start with immunology.

We had several regulatory updates and data readouts for both the <unk> and sky receipt across therapeutic areas.

Jeffrey Ryan Stewart: Lastly, in our other key therapeutic areas, we saw a significant contribution from eye care, which had revenues of $871 million, up 2.9% on an operational basis. Maverick sales were $426 million, up 2.9% on an operational basis, as treated patient volumes still remain suppressed compared to pre-COVID levels, and we saw double-digit growth operationally for both Creon and Lupron. So overall, I'm pleased with our continued execution across the therapeutic portfolio, which is demonstrating strong revenue growth. And with that, I'll turn the call over to Mike for additional comments on our R&D programs. Mike?

Following successful completion of the Registrational programs for <unk> in ulcerative colitis, and Sky <unk> in Crohn's disease, we submitted our regulatory applications for each asset in their respective indications.

We saw very strong data for both <unk> and sky rosy as induction and maintenance treatments in UC and Crohn's respectively.

And based on these results we believe both drugs have the potential to become a highly effective differentiated therapies in these indications.

We anticipate approval decisions for both in 2022.

Earlier this month, we announced positive topline results from our phase III select access two program for <unk> in axial spa.

Which included data from two Standalone studies.

One for ankylosing spondylitis patients, who had an inadequate response to biologics and another for patients with non radiographic axial spa.

Michael Severino: Thank you, Geoff. I'll start with immunology, where we had several regulatory updates and data readouts for both the RINVOK and SkyRISI across therapeutic areas. Following the successful completion of the registrational programs for RINVOC in ulcerative colitis and SCIRISI in Crohn's disease, we submitted our regulatory applications for each asset in their respective indications. We saw very strong data for both RINVOC and SCIRISI as induction and maintenance treatments for UC and Crohn's, respectively.

And the ankylosing spondylitis bio refractory study RIN broke performed very well demonstrating significantly greater improvements in signs and symptoms as well as physical function and imaging endpoints compared to placebo.

We saw levels of efficacy in this difficult to treat refractory population similar to those more typically observed in bio naive patients.

These results will be added to our submission package for <unk>, which is currently under review by the FDA.

And the non radiographic axial Spa study <unk> also performed very well meeting the primary and key secondary endpoints.

Michael Severino: Based on these results, we believe both drugs have the potential to become highly effective differentiated therapies in these indications. We anticipate approval decisions for both in 2022. Earlier this month, we announced positive top-line results from our Phase 3 Select Access 2 program for Renvoke and AxialSpot, which included data from two standalone studies, one for ankylosing spondylitis patients who had an inadequate response to biological therapy and another for patients with non-radiographic axial spas. In the ankylosing spondylitis biorefractory study, Rynbroke performed very well, demonstrating significantly greater improvement in signs and symptoms, as well as physical function and imaging endpoints compared to placebo.

We plan to submit our regulatory applications in this indication later this quarter as well.

<unk> safety profile in these axial spa trials was consistent with previous studies and there was no evidence for increase risk of DVT PE mace events or malignancies in either study.

Based on the data generated in the select access program. We believe <unk> has the potential to improve care for patients suffering from axial spondylarthritis by providing sustained disease control and rapid and durable pain reduction as well as improving function.

As youre likely aware in September the FDA communicated that they will require new warnings for JAK inhibitors, including <unk> bulk and their use will be limited to certain patients who have not responded to or cannot tolerate anti TNF.

Michael Severino: We saw levels of efficacy in this difficult-to-treat refractory population, similar to those more typically observed in bio-naive patients. These results will be added to our submission package for RINVOC and AS, which is currently under review by the FDA. In the non-radiographic axial spas study, Rynvilk also performed very well, meeting the primary and key secondary endpoints. We plan to submit our regulatory applications in this indication later this quarter as well. ReInvoke's safety profile in these axial spa trials was consistent with previous studies, and there was no evidence of increased risk of DVT, PE, MACE events, or malignancies in either study.

We continue to work with the FDA regarding updated labeling language for the <unk> indication.

While simultaneously engaging with the agency on our files for atopic dermatitis, Psoriatic arthritis, and ankylosing spondylitis.

We remain confident in our submission packages for these three new indications and continue to expect approvals following completion of the <unk> label update.

In the area of oncology, we continue to make good progress advancing all stages of our pipeline.

We're nearing completion of several indication expansion programs for <unk>.

In our study in previously untreated higher risk Mds patients, which recently received a breakthrough therapy designation we.

We expect to make a data cut early next year to include six month follow up data for duration of response.

Michael Severino: Based on the data generated in the Select Access Program, we believe RINVOC has the potential to improve care for patients suffering from axial spondyloarthritis by providing sustained disease control and rapid and durable pain reduction, as well as improving function. As you're likely aware, in September, the FDA communicated that it would require new warnings for JAK inhibitors, including RINVOC, and their use will be limited to certain patients who have not responded to or cannot tolerate anti-TNF.

Based on this data cut we plan to submit our regulatory application to the FDA in the first half of 2022 for an accelerated approval.

We continue to make good progress with <unk> in the Canova trial, which is evaluating <unk> in relapsed refractory multiple myeloma patients with a T 11 14 mutation.

<unk> has shown strong anti myeloma activity in this biomarker defined population and if successful has an opportunity to play an important role in the treatment paradigm for multiple myeloma.

Michael Severino: We continue to work with the FDA regarding updated labeling language for the RA indication while simultaneously engaging with the agency on our files for atopic dermatitis, psoriatic arthritis, and ankylosing spondylitis. We remain confident in our submission packages for these three new indications and continue to expect approvals following completion of the RA label update. In the area of oncology, we continue to make good progress advancing all stages of our pipeline. We're nearing completion of several Indication Expansion Programs, including our study in previously untreated higher-risk MDS patients, which recently received a breakthrough therapy designation. We expect to make a data cut early next year to include six-month follow-up data for duration of response.

We expect the data readout from this event driven trial next year.

And our early to mid stage <unk> pipeline.

We continue to expand the cohorts in the up credit Mab phase one two studies in diffuse large b cell lymphoma, and Follicular lymphoma, and we are evaluating <unk> as both a monotherapy and in combinations.

We expect to see data from both the monotherapy and combo studies next year, and we will discuss the monotherapy data with regulators regarding a file for accelerated approval.

We also recently began the dose escalation stage of the phase <unk> studies for Lemzo Parliament, and AML Mds and multiple myeloma.

And ABV 383, or <unk> by specific antibody is currently in the expansion stage of its phase one study in multiple myeloma patients and we expect to begin Registrational phase III studies next year.

Michael Severino: Based on this data cut, we plan to submit our regulatory application to the FDA in the first half of 2022 for an accelerated approval. We continue to make good progress with BenClexta in the CANOVA trial, which is evaluating BenClexta in relapsed refractory multiple myeloma patients with a T11-14 mutation. VanClexta has shown strong anti-myeloma activity in this biomarker-defined population and, if successful, has an opportunity to play an important role in the treatment paradigm for multiple myeloma.

Moving to neuroscience, where we had several notable pipeline events since our last earnings call.

In September we received FDA approval for <unk>.

The only oral <unk>, specifically designed as a preventative treatment for migraine.

We're very pleased with the label, which reflects <unk> strong benefit risk profile and is supported by a robust clinical development program.

Michael Severino: We expect a data readout from this event-driven trial next year, in our early to mid-stage HEMON pipeline. We continue to expand the cohorts in the EPCRIT and MAB Phase 1-2 studies in diffuse large B-cell lymphoma and follicular lymphoma, and we're evaluating f-carinamide as both monotherapy and in combination.

And our Registrational program, which evaluated <unk> in nearly 2000 patient suffering from episodic migraine treatment with <unk> resulted in a significant reduction in mean monthly migraine days compared to placebo in approximately 60% of patients achieved at least a 50% reduction in <unk>.

Michael Severino: We expect to see data from both the monotherapy and combo studies next year, and we will discuss the monotherapy data with regulators regarding a file for accelerated approval. We have also recently begun the dose escalation stage of the Phase 1b studies for Lems of Parlimat in AML, MDS, and multiple myeloma, and ABBV383, our BCMA CD3 bispecific antibody, is currently in the expansion stage of its phase one study in multiple myeloma patients, and we expect to begin registrational phase three studies next year. Moving to neuroscience, where we have had several notable pipeline events since our last earnings call. In September, we received FDA approval for QLIPDA. The only oral CGRP specifically designed as a preventative treatment for migraines.

Grand days.

We think these data compare favorably to other preventative migraine treatments on the market and believe our new oral treatment option will be competitively positioned in the prevention market.

Our migraine portfolio now includes <unk> for acute treatment of migraine Q lifter for preventative treatment of episodic migraine and botox for preventative treatment of chronic migraine with.

This distinct portfolio Abbvie is uniquely positioned to address the full spectrum of this complex and debilitating disease.

This morning, we announced topline results from two phase III studies evaluating <unk> as an adjunctive treatment in major depressive disorder.

In the 301 study the one five milligram bid for a large dose met the primary endpoint demonstrating a clinically meaningful improvement in total noninterest score compared to placebo at week six with a highly statistically significant P value of 0.005.

Michael Severino: We're very pleased with the label, which reflects QLIP's strong benefit-risk profile and is supported by a robust clinical development program. In our registrational program, which evaluated QLIPTA in nearly 2,000 patients suffering from episodic migraine, treatment with QLIPTA resulted in a significant reduction in mean monthly migraine days compared to placebo, and approximately 60% of patients achieved at least a 50% reduction in mean migraine days. We think these data compare favorably to other preventative migraine treatments on the market and believe our new oral treatment option will be competitively positioned in the prevention market.

In this study the three milligram <unk> dose did not reach statistical significance, but it did show a clear trend toward improvement with a nominal P value of approximately 0.073 at week six.

In the second phase III trial, the 302 study neither <unk> dose met the primary endpoint of change in total micro score at week six but both the one five and three milligram doses demonstrated clear trends toward a clinically meaningful benefit in weeks, two and four with nominal P value.

Michael Severino: Our migraine portfolio now includes Ubrelvi for the acute treatment of migraine, Q-Lypta for the preventative treatment of episodic migraine, and Botox for the preventative treatment of chronic migraine. With this distinct portfolio, AbbVie is uniquely positioned to address the full spectrum of this complex and debilitating disease. This morning, we announced top-line results from two Phase 3 studies evaluating Braylor as an adjunctive treatment for major depressants. In the 301 study, the 1.5 milligram Braylor dose met the primary endpoint, demonstrating a clinically meaningful improvement in total Madras score compared to placebo at week six with a highly statistically significant p-value of 0.005. In this study, the 3 mg Braylar dose did not reach statistical significance.

I use less standpoint zero five for a number of comparisons.

Additionally, as a reminder, we had one prior positive Registrational phase <unk> study, where <unk> demonstrated efficacy in <unk> when added to ongoing antidepressant trades.

Based on precedent in the field and the totality of the data. We believe we have a viable regulatory pathway for <unk> as an adjunct treatment in major depressive disorder.

We plan to engage with regulatory agencies to discuss these results and expect to submit our regulatory application to the FDA in the first half of next year.

We also recently announced positive top line results from our Phase III study comparing our novel subcutaneous Levodopa Carbo dopa delivery system, a BBB 90, 512, oral levodopa carbo dopa in patients with advanced Parkinson's disease.

Michael Severino: But it did show a clear trend toward improvement with a nominal p-value of approximately 0.073 at week six. In the second phase 3 trial, the 302 study, neither Veralar dose met the primary endpoint of change in total Madras score at week 6, but both the 1.5 and 3 milligram doses demonstrated clear trends toward a clinically meaningful benefit at weeks 2 and 4, with nominal p-values less than 0.05 for a number of comparisons.

In this pivotal study treatment with 95, one resulted in clinically meaningful improvement in on time without troublesome dyskinesia as well as similar improvements normalized off time compared to oral levodopa carbon notebook.

We're very pleased with these results, which we believe supports our view that 95, one has the potential to become a transformative improvement to current treatment options for patients with advanced Parkinson's disease.

We plan to submit our regulatory application next year with approval decisions anticipated in the U S and Europe in early 2023.

And in Eyecare.

Michael Severino: Additionally, as a reminder, we had one prior positive registration of a phase 2B study where Raylar demonstrated efficacy in MDD when added to ongoing antidepressants. Based on precedent in the field and the totality of the data, we believe we have a viable regulatory pathway for Braylor as an adjunctive treatment for major depressive disorder.

We announced a partnership with <unk> to develop and commercialize our gx $3 14, a potential gene therapy for the treatment of wet AMD diabetic retinopathy and other chronic retinal diseases.

<unk> hundred 14 is a very attractive addition to our pipeline and complements our eye care portfolio with a potential flagship product and retinal disease.

<unk> bio recently presented initial data from two phase II studies evaluating <unk> 314 in wet AMD and diabetic retinopathy using inoffice Super choroidal delivering.

Michael Severino: We plan to engage with regulatory agencies to discuss these results and expect to submit our regulatory application to the FDA in the first half of next year. We also recently announced positive top-line results from a Phase 3 study comparing our novel subcutaneous levodopa-carbidopa delivery system, ABVB-951, to oral levodopa-carbidopa in patients with advanced Parkinson's, In this pivotal study, treatment with 9-5-1 resulted in clinically meaningful improvement in on-time, without troublesome dyskinesia, as well as similar improvement in normalized off-time compared to oral levodopa carbidopa.

While early these results are encouraging with <unk> 314, demonstrating efficacy at the lowest dose and the study showing that the drug and delivery method, both appear to be well tolerated.

Also in eye care, we continue to expect approval for beauty shortly formerly known as AGN 190584 for the treatment of symptoms associated with presbyopia.

This once daily eye drop was developed to help address the presbyopia that is often corrected through reading glasses and once approved would be a convenient on demand solution for patients with mild to moderate presbyopia, who may not want to wear reading glasses.

Michael Severino: We're very pleased with these results, which we believe support our view that 951 has the potential to become a transformative improvement to current treatment options for patients with advanced Parkinson's. We plan to submit our regulatory application next year, with approval decisions anticipated in the U.S. and Europe in early 2023. And at iCare, we announced a partnership with Regenexx Bio to develop and commercialize RGX 314. Potential gene therapy for the treatment of wet AMD, diabetic retinopathy, and other chronic retinal diseases

This has been a very productive year, thus far for our R&D organization and we anticipate several additional milestones in the coming months.

We expect this momentum to continue into next year, which is looking to be a milestone filled year for abbvie as well.

With that I'll turn the call over to Rob for additional comments on our third quarter performance and financial outlook, Rob. Thank you Mike as you have heard from Rick Jeff and Mike. We once again delivered outstanding performance. This quarter, while also advancing our strategic priorities our results demonstrate the strong momentum of the business and support these long.

Michael Severino: RGX 314 is a very attractive addition to our pipeline and complements our eye care portfolio with a potential flagship product in retinal disease. Regenexx Bio recently presented initial data from two Phase II studies evaluating RGX314 in wet AMD and diabetic retinopathy using in-office supracaroidal delivery. While early, these results are encouraging, with RGX314 demonstrating efficacy at the lowest dose, and studies showing that the drug and delivery method both appear to be well-tolerated.

Term financial outlook.

Turning to third quarter results, we reported adjusted earnings per share of $3 33.

Up 17, 7% compared to prior year and 13 above our guidance midpoint. This includes <unk> from accelerated synergies and three from mark to market equity gains.

Total adjusted net revenues were $14 3 billion.

Up 10, 8% on operational basis, excluding a 0.5% favorable impact from foreign exchange.

Michael Severino: Also in eye care, we continue to expect approval for VUITY, formerly known as AGN 190584, for the treatment of symptoms associated with presbyopia. This once-daily eyedrop was developed to help address the presbyopia that is often corrected through reading glasses and, once approved, would be a convenient, on-demand solution for patients with mild to moderate presbyopia who may not want to wear reading glasses.

The adjusted operating margin ratio was 51, 1% of sales an improvement of 230 basis points versus the prior year. This includes adjusted gross margin of 83, 2% of sales adjusted R&D investment of 11, 4% of sales and adjusted SG&A expense of 26%.

Sales net interest expense was $585 million and the adjusted tax rate was 12, 6%.

As Rick previously mentioned, we are raising our full year adjusted earnings per share guidance to between $12 63.

Robert A. Michael: This has been a very productive year thus far for our R&D organization, and we anticipate several additional milestones in the coming months. We expect this momentum to continue into next year, which is looking to be a milestone-filled year for AbbVie as well. With that, I'll turn the call over to Rob for additional comments on our third quarter performance and financial outlook.

And $12 67.

Collecting growth of 19, 8% at the midpoint.

Excluded from this guidance is $6 34.

Of known intangible amortization and specified items.

This guidance continues to contemplate full year revenue growth of 10, 7% on a comparable operational basis.

At current rates, we now expect foreign exchange had a 0.7% favorable impact on full year comparable sales growth. This implies a full year revenue forecast of approximately $56 $2 billion.

Robert A. Michael: Thank you, Mike. As you have heard from Rick, Geoff, and Mike, we once again delivered outstanding performance this quarter while also advancing our strategic priorities. Our results demonstrate the strong momentum of the business and support AbbVie's long-term financial outlook. Turning to third-quarter results, we reported adjusted earnings per share of $3.33, up 17.7% compared to the prior year and $0.13 above our guidance midpoint. This includes $0.05 from accelerated synergies and $0.03 from mark-to-market equity gains.

Included in this guidance are the following updated full year assumptions, we now expect aesthetics global revenue of approximately $5 $1 billion. We now expect international Humira sales of approximately $3 3 billion from <unk>. We now expect global revenue of approximately $5 5 billion.

Reflecting slower recovery of the CLO market.

For Maverick, we now expect global sales of approximately $1 7 billion.

And we now expect Allergan expense synergies of approximately $1 8 billion.

As we look ahead to the fourth quarter, we anticipate net revenue approaching $15 billion at current rates, we expect foreign exchange had a modest unfavorable impact on sales growth.

Robert A. Michael: Total adjusted net revenues were $14.3 billion, up 10.8% on an operational basis, excluding a 0.5% favorable impact from foreign exchange. The adjusted operating margin ratio was 51.1% of sales, an improvement of 230 basis points versus the prior year. This includes an adjusted gross margin of 83.2% of sales, adjusted R&D investment of 11.4% of sales, and adjusted SG&A expense of 20.6% of sales. Net interest expense was $585 million, and the adjusted tax rate was 12.6%.

We expect adjusted earnings per share between $3 24 and.

And $3 28.

Excluding approximately $1 14.

Of known intangible amortization and specified items.

Finally, <unk> strong business performance continues to support our capital allocation priorities, we generated $17 billion of free cash flow in the first nine months of the year and our cash balance at the end of September was $12 billion.

Underscoring our confidence in <unk> long term outlook today, we announced an eight 5% increase in our quarterly cash dividend beginning with the dividend payable in February 2022, and we remain on track to achieve $17 billion of cumulative debt paydown by the end of this year with further deleveraging through 2023 this will be.

Robert A. Michael: As Rick previously mentioned, we are raising our full-year adjusted earnings per share guidance to between $12.63 and $12.67, reflecting growth of 19.8% at the midpoint. Excluded from this guidance is $6.34 of known intangible amortization and specified items.

Our net leverage ratio to two three times by the end of 2021 and approximately two times by the end of 2022.

Robert A. Michael: This guidance continues to contemplate full-year revenue growth of 10.7% on a comparable operational basis. At current rates, we now expect foreign exchange at a 0.7% favorable impact on full-year comparable sales growth. This implies a full-year revenue forecast of approximately $56.2 billion. Also included in this guidance are the following updated FOIA assumptions.

In closing Abbvie has once again delivered outstanding results and our financial outlook remains very strong 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 operator, we'll take the first question.

Thank you Ms. Shang. Our first question comes from Geoffrey Porges with Leerink. Your line is open Sir.

Thank you very much.

Robert A. Michael: We now expect aesthetics global revenue of approximately $5.1 billion. Additionally, we now expect international Humira sales of approximately $3.3 billion. From Bruvica, we now expect global revenue of approximately $5.5 billion, reflecting a slower recovery of the CLL market. For Maverette, we now expect global sales of approximately $1.7 billion. And we now expect Allergan expense synergies of approximately $1.8 billion. As we look ahead to the fourth quarter, we anticipate net revenue approaching $15 billion. At current rates, we expect foreign exchange to have a modest, unfavorable impact on sales growth.

I guess I'll jump in with the Big one that I think is still the overhang for the stock which is the <unk> outlook.

You have 15 billion out there for 2025 and combined <unk> <unk> four.

Our cost guidance.

I'm just wondering if you could give us a sense of the puts and takes Scott really doing really well, but some overhangs for embark.

Is that $15 billion still achievable or do you think youre trending above that or do you have to make up a shortfall.

Yeah. Jeffrey this is Rick it's a great question.

Say is the following if I look at Sky with the.

I would tell you that <unk> performance is very very impressive.

Jeff outlined with the in play share is and what the total TR actions are and it's very close to passing Humira now.

Which in this short period of time is frankly, a surprise how quickly. It is ramp. So I think that's very positive case, if I look at Rainbow actually the <unk> looks very good.

Robert A. Michael: We expect adjusted earnings per share between $3.24 and $3.28, excluding approximately $1.14 of known intangible amortization and specified items. Finally, AbbVie's strong business performance continues to support our capital allocation priorities. We generated $17 billion of free cash flow in the first nine months of the year, and our cash balance at the end of September was $12 billion.

Now, we would expect if a label change and restricts restricts.

Restricts the label.

Behind.

CNS that that will have some impact on the on the frontline patients.

<unk> that were capturing now and.

So we will see that impact having said that I would say that when I look at <unk> performance overall, how durable it has been throughout this.

The situation.

Robert A. Michael: Underscoring our confidence in AbbVie's long-term outlook, today we announced an 8.5% increase in our quarterly cash dividend, beginning with the dividend payable in February 2022, and we remain on track to achieve $17 billion of cumulative debt paydown by the end of this year, with further deleveraging through 2023. This will bring our net leverage ratio to 2.3 times by the end of 2021 and approximately two times by the end of 2022. In closing, AbbVie has once again delivered outstanding results, and our financial outlook remains very strong.

We will obviously shift more towards.

Second line patients and beyond which was originally in the plan, but the emphasis would've occurred a year or two later than this where we would have driven that we have very good data to be able to support that the other thing I'd say is if you look at.

At the indications that we have coming out for these two assets.

We have a D, which is a very significant opportunity for us we have TSA.

<unk> is a very significant opportunity, but next year, we have the IBD indications that are coming out and I'd say there when we gave the $15 million for gas.

Performance that was in our TPP or our target product profile that we had assumed we have outperformed that in the clinical trials that we've submitted and so I think thats, a very significant opportunity for us and a significant opportunity for us to outperform having said all of that we don't want a weakened.

Robert A. Michael: With that, I'll turn the call back over to Liz. Thanks, Rob. We will now open the call to 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. Operators will take the first question.

Pulling the guidance yet we wanted to see what the final label looks like from the from the agency.

And then we'll be in a position I think to come out and until the investor community exactly what you're saying.

The only other thing I'd say is yes.

I think if you go back five six years ago, what we were trying to accomplish with the campaign, we were basically drilling more problems with the company build a set of assets that could ultimately significantly.

Operator: Thank you, Ms. Shea. Our first question comes from Jeffrey Porges with Lee Ring. Your line is open, sir.

Jeffrey Porges: Thank you very much. Rick, I guess I'll jump in with the big one that I think is still the overhang for the stock, which is the RINVOC Outlook. You have $15 billion out there for 2025 in combined SCORESIA RINVOC forecast guidance, and I'm just wondering if you could give us a sense of the puts and takes. SCORESIA is doing really well, but there are some overhangs for RINVOC. Is that $15 billion still achievable? Do you think you're trending above that? Or do you have to make up a shortfall? Thanks. Yeah, I mean, Jeffrey, this is Rick.

<unk> humira in the marketplace and be superior to Humira and these two assets already are at $5 billion and growing very rapidly.

So I think everything I know about these two assets there'll be able to do exactly what we expected of them.

Even in the most.

Negative outcome from a label standpoint that we would expect second opinions, we build a significant.

<unk> portfolio that when I look at the pipeline behind them <unk> I think there's a significant opportunity.

Drive.

Significant growth in that portfolio, and then with the Allergan acquisition I couldnt be more pleased and aesthetics franchise is performing outstanding level. The neuroscience franchise is performing outstanding level I think migraine.

Rick Gonzalez: It's a great question. What I'd say is the following. If I look at Sky Rizzi, I would tell you that Sky Rizzi's performance is very, very impressive. You know, Geoff outlined what the in-play share is and what the total TRXs are, and it's very close to passing the Marin, which in this short period of time is, frankly, a surprise how quickly it has rammed. So I think that's a very positive case. If I look at RENVO, the implant share actually looks very good.

It is a very significant opportunity for us to be able to drive and here's another one and so we now have multiple assets and multiple portfolios to be able to drive the growth. Our goal is still what we've described to the analysts.

Early on we.

We expect.

To see the impact of <unk> on Humira in 2003, and immediately be able to grow beyond that starting in 'twenty four returned to growth sales growth at that point and regardless of what happens with the <unk> label.

Rick Gonzalez: Now, we would expect if the label gets changed and restricts the label to behind TNFs, that that will have some impact on the frontline patients, the IA patients that we're capturing now. And so we will see that impact. Having said that, I would say that when I look at RENVO's performance overall and how durable it has been throughout this situation, it will obviously shift more towards second-line patients and beyond, which was originally in the plan, but the emphasis would have occurred a year or two later than this, when we would have driven that.

I have a high level of confidence we can continue to do that.

Rob anything you'd add.

I would just I would just add that obviously with the confidence we have in the dividend increase we announced today, we feel very strong about the long term outlook, we havent backed off on the high single digit growth on 25 and beyond when you look at the portfolio. We've assembled if you look at the assets. We have today you look at our pipeline you look at the BD work, we've been doing over the last couple of years.

<unk> had some nice licensing deals and we still feel very confident outlook for this business.

Alright, thank you.

Thanks, Geoffrey Operator next question please.

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

Rick Gonzalez: We have very good data to be able to support that. The other thing I'd say is if you look at the indications that we have coming out for these two assets, we have AD, which is a very significant opportunity for us. We have PSA, and it's a very significant opportunity. But next year, we have the IBD indications that are coming out.

Yes. Thank you could you flip back to the other side of it.

<unk> just took to Humira could you talk to your comfort level with where consensus currently has humira pegged and the anticipated scale and scope of the erosion and then secondly MLS.

In relation to your ongoing alphatec.

Rick Gonzalez: And I'd say there, when we gave the $15 billion forecast, the performance that was in our TPP or our target product profile that we had assumed, we have outperformed that in the clinical trials that we've submitted. And so I think that's a very significant opportunity for us and a significant opportunity for us to outperform. Having said all of that, we don't want to reconfirm the guidance yet.

Pending court case could you just confirm whether if they prevail that would effectively in panel date, we signed settlements with the other Biosimilar class meeting that you would have a number of clients cutting that much quicker onto the market with anticipated price and volume impacts.

Okay. Andrew This is Rick so I'll cover the second one the Alphatec, one I'm going to have Rob.

Cover the first one yes, we've seen movement in terms of consensus numbers since we've given to some.

The direction on how to model. It I think right now consensus in 'twenty three sell side consensus is about 41% erosion.

Rick Gonzalez: We want to see what the final label looks like from the agency. And then we'll be in a position, I think, to come out and tell the investor community exactly what. The only other thing I'd say is... You know, I think if you go back five, six years ago, what we were trying to accomplish with the company, we were basically trying to accomplish with the company, build a set of assets that could ultimately significantly replace Humira in the marketplace and be superior to Humira.

In the U S and 23, and we've said.

Think about it in terms of 45% based on what we saw in Europe in year, one plus or minus 10% given the differences in the.

Payer landscape.

In the U S versus other markets. So we have seen the humira consensus move today, it's at 41%. So it's a lot closer than it was a year ago.

Okay. Andrew This is Rick I'll cover the Alphatec situation. So as you know we're in litigation with Alphatec.

I think it is important to understand the.

Rick Gonzalez: These two assets are already at $5 billion and growing very rapidly, so I think everything I know about these two assets, they'll be able to do exactly what we expected. Even in the most negative outcome from the labels, which we would expect. Second thing is we built a significant... Heemant Portfolio, that when I look at the pipeline behind Imbruvica and then Clutched, I think there's a significant opportunity. [inaudible] I think we're performing at an outstanding level. I think migraine is a very significant opportunity for us to be able to drive, and Eye Care is another one.

The nuances behind that litigation. So in this first set of litigation. This first wave of litigation we are.

We are basically applying 10 patents and Humira and as you know we have a very robust patent portfolio around humira, but these 10 patents are both formulation patents and indication patents. Many of these patents that were challenged through the IPR the IPR process and upheld by the patent office. So did you see.

Idea of the strength of these patents. So the first thing I'd say to you is we have a high level of confidence.

We will prevail in this litigation there will be a second wave of litigation that occurs after that which will.

Which will bring into the portfolio the rest of the patents that we think Alphatec infringes.

Rick Gonzalez: And so we now have multiple assets and multiple portfolios to be able to drive growth, and our goal is still what we described to the analysts early on. We expect to see the impact of the LOE on Humira in 23 and immediately be able to grow beyond that starting in 24, returning to growth and sales growth at that point. [inaudible] I would just add that, obviously, with the confidence we have and the dividend increase we announced today, we feel very strong about the long-term outlook.

So there could be another phase of litigation that occurs after this one but I can tell you. We're highly confident that we will prevail in this first settled litigation based on the strength of those patents to specifically answer your question.

If they were to prevail, which I don't believe they will.

Then it would accelerate the other patent settlements, yes that is correct.

Thank you Andrew Operator next question please.

It comes from Chris Schott with J P. Morgan Your line is open Sir.

Alright, great. Thanks, so much just one quick follow up on <unk> and the upcoming indications I guess do you see a scenario where you're unable to get the drug approved in this pending indications, particularly a D. Over the next few months or is your view based on all the interactions et cetera that this is largely I guess a label and may.

Rick Gonzalez: We haven't backed off on the high single-digit growth for 25 and beyond. You look at the portfolio we've assembled, you look at the assets we have today, you look at our pipeline, you look at the BD work we've been doing over the last couple of years with some nice licensing deals, and we still feel very confident in the outlook.

Your line of therapy kind of discussion and decision with the agency and.

And then my second question was on Botox aesthetics.

Rick Gonzalez: Thanks, Jeffrey. Operator, next question, please. Thank you. Our next question is from Andrew Baum with Citi. Your line is open, sir.

<unk> healthy growth Youre seeing here, we're now coming up against even some more normalized comps and you're still seeing the growth rate.

Andrew Simon Baum: Could you talk to me about your comfort level with where consensus currently has Humira pegged and the anticipated scale and scope of the erosion? And then second, in relation to your ongoing Albatec pending court case, could you just confirm whether, if they prevail, that would effectively invalidate the signed settlement with the other bi-similar players, meaning that you would have a number of players coming that much quicker onto the market with anticipated price and volume impacts? Thank you.

Very very healthy just are we still seeing catch up usage in this or is this just really underlying demand at this point and just a little bit more color, but just how youre thinking about kind of the near term growth trajectory. I know you talked about high single digits over time, but just asking me to look out to 'twenty two 'twenty three could this remains kind of a.

Mid teens type of growth rate product over over that window. Thanks, so much.

Okay. Thanks, Chris This is Mike I'll take the first one and then Rick will take the second part of your question with respect to <unk> and the three new indications psoriatic arthritis atopic dermatitis.

Rick Gonzalez: Okay, Andrew, this is Rick. So I'll cover the second one, the Albatek one; I'm going to have Rob cover the first one. Yeah, we've seen movement in terms of consensus numbers since we've given just some... Direction on how to model it.

In ankylosing spondylitis, we remain very confident in those files and we remain very confident in approval decisions. The gaining factor here is really getting to the specifics of the language around <unk>, which is a process that is well underway and.

Rick Gonzalez: I think right now, consensus in 23, and Southside consensus has about 41% erosion in the US in 23. And we've said, you know, think about it in terms of, you know, 45% based on what we saw in Europe in year one, plus or minus 10% given the differences in the pair landscape in the U.S. versus other markets. So, we have seen the American census move. Today, it's at 41%, so it's a lot closer than it was a year ago.

And we would expect to be in a position.

To gain approvals.

After that is completed and again, we hope that's completed.

Many of our future certainly certainly this year.

The psoriatic arthritis, and atopic dermatitis filings, we would expect to follow fairly closely on the heels of that or a decision for ankylosing spondylitis as I mentioned in my prepared remarks, we rolled in a new study, which is a positive study in a very strong study in ankylosing spondylitis into that submission and so that one might be on a slightly different timeframe, but we are.

Robert A. Michael: Okay Andrew, this is Rick. I'll cover the Alvitek situation. So, as you know, we're in litigation with Alvitek. I think it's important to understand the nuances behind that litigation. So in this first set of litigation, this first wave of litigation, we are basically applying 10 patents in NUMERA, and as you know, we have a very robust patent portfolio around. But these 10 patents are both formulation patents and indication patents.

Main very confident in that approval as well.

Okay.

As Rick on Botox.

I think one of the things when we first went through the integration process that was compelling to US was the amount of penetration in these markets and allergens ability to be able to reach out and touch consumers and activate those consumers.

And that's part of what drove our decision globally to go with this fully integrated.

Totally dedicated aesthetics organization because in many other markets around the world. Although the data is not quite as good as it is here in the U S or in China. As an example, you see very similar kinds of dynamics and so focusing that team purely on aesthetics was was part of the effort here to be able to drive accelerated growth.

Robert A. Michael: Many of these patents were challenged through the IPR process and upheld by the Patent Office, so it gives you some idea of the strength of these patents. So the first thing I'd say to you is that we have a high level of confidence that we will prevail in this election. There will be a second wave of litigation that occurs after that, which will bring into the portfolio the rest of the patents that we think ALBATEK infringes.

It was when we looked at the ability to be able to.

Use various methods to be able to activate consumers.

We believe that the business was being underfunded.

In a way.

Both in the way it was being funded in the total amount that was being funded and so we did some early work to determine whether or not that funding could drive incremental market growth and it showed a positive result, and then when we saw that we applied significantly greater funding to it.

Robert A. Michael: So there could be another phase of litigation that occurs after this one, but I can tell you we're highly confident that we will prevail in this first set of litigation, specifically to answer your question. You know, if they were to prevail, which I don't believe they will, then it would accelerate the other patents settling.

And what Youre actually seeing now I think is we are driving the market, we're bringing more patients into the category and obviously because we have the leadership position from a market share standpoint, we get.

The vast majority of those patients.

Rick Gonzalez: Thank you, Andrew. Operator, next question, please. Thank you. This call comes from Chris Schott with J.P. Morgan. Your line is open, sir. Good.

Is there still some.

Pent up demand I would tell you it's hard to believe at this point that there can be a lot of it but there has to be some of it right. As you remember those practices reopened in the U S. In the summer of 2020. So that's a long time that pent up demand, but it's impossible to tell one way or another so I would say that.

Chris Schott: All right, great. Thanks so much.

Chris Schott: Just one quick follow-up on RINVOC and the upcoming indications. I guess, do you see a scenario where you are unable to get the drug approved in these pending indications, particularly AD, over the next few months? Or is your view, based on all the interactions, et cetera, that this is largely, I guess, a label and maybe line of therapy kind of discussion and decision with the agency?

Majority of it is certainly being driven by us activating patients.

And retaining more patients one of the other things we saw was that.

Retention rate was relatively low once you activated a patient and so we spent some time working with the team to figure out how could you retain those patients at a higher rate, meaning the rupee.

Procedures. They don't just do it once and then disappear, but they come back for a second procedure or costs.

Chris Schott: And my second question was on Botox aesthetics. Very healthy growth you're seeing here. We're now coming up against some more normalized comps, and you're still seeing the growth rate very, very healthy. Are we still seeing catch-up usage in this, or is this just really underlying demand at this point? And just a little bit more color about just how you're thinking about the nearer term growth trajectory. I know you talked about high single digits over time, but just as we may look out to 22, 23, could this remain kind of a mid-teens type of growth rate product over that window? Thanks so much.

Go into pillars as an example.

So the data is very clear if you look at the U S. As an example, toxins and pillars of growing a high 30 percents the markets were growing at about the same rate.

Maybe a little bit lower on pillars, but about that rate on <unk> when we look at globally.

The overall brands are growing at about that rate and so I think this is a business that is sustainable over the long term when we say across the decade high single digits. Obviously, if we keep this growth rate the business is getting bigger and bigger.

So therefore, the percentage will come down a bit but I would tell you I'm very optimistic about this in this market.

And our ability to be able to bring new assets into this market. They can change the standard of care going forward and us being able to drive market growth at the same time, it's a very good business.

Mike: Mike. Okay, thanks, Chris. This is Mike. I'll, I'll take the first one.

Thank you Chris Operator, we'll take the next question. Please.

Rick Gonzalez: And then Rick will take the second part of your question. With respect to RINVOC and the three new indications, so psoriatic arthritis, atopic dermatitis, and ankylosing spondylitis, we remain very confident in those files, and we remain very confident in approval decisions. The gaining factor here is really getting to the specifics of the language around RA, which is a process that is well underway, and we would expect to be in a position to gain approvals after that is completed. And again, we hope that it is completed in the near future, certainly this year.

Thank you that comes from Tim Anderson with Wolfe Research. Your line is open Sir.

Thank you I wanted to ask a question on Humira in 2023.

And just really trying to nail down what's in that.

Erosion guidance of 45% plus or minus 10, that's sales erosion not volume correct.

I'm trying to think through what happens to the U S rebate stream and.

In 2023, which is likely in the billions of dollars do you think youll retain favorable formulary positioning even with Biosimilars in which case you keep paying that repaid but you also would have less volume loss.

Or do you think it becomes disadvantage on formulary.

In which case you pulled back those billions of dollars in rebates.

Rick Gonzalez: The psoriatic arthritis and atopic dermatitis findings, we would expect to follow fairly closely on the heels of that RA decision. For ankylosing spondylitis, as I mentioned in my prepared remarks, we've rolled in a new study, which is a positive study and a very strong study in ankylosing spondylitis, into that submission, and so that one might be on a slightly This is Rick on Botox.

And that flows through to the bottom line.

I just wonder if your guidance on erosion.

It was frankly too conservative or too.

Aggressive because those rebate dynamics in the U S.

Make us a more durable market ex U S for those rebate dynamics don't exist okay.

So Tim this is Rick maybe Rob and I will tag team. This one.

I'll start.

I think the guidance, we laid out of 45 or 48% whichever is the latest number plus or minus 10% is still a guidance that we feel pretty comfortable with to your point about is the bulk of it price. It is.

Rick Gonzalez: I think one of the things when we first went through the integration process that was compelling to us was the amount of penetration in these markets and Allergan's ability to reach out and touch consumers and activate those. And that's part of what drove our decision globally to go with this fully integrated, you know, totally dedicated aesthetics organization because in many other markets around the world, although the data is not quite as good as it is here in the US, but in China, as an example, you see very similar kinds of dynamics. And so focusing that team purely on aesthetics was part of the effort here to be able to accelerate the process.

Is even.

Even if you look at the international markets. It's about one third two thirds and maybe slightly higher than that.

I mean, two thirds of its probably one third of it is volume and I would expect that we will maintain a significant part of the volume.

Obviously, we don't talk publicly about what our managed care strategy is but what I would tell you is we're close enough now into that 'twenty three time frame that you would expect us to be starting the work to ensure formulary access on all of our products and certainly.

Humira is one of those.

2023 and.

I think it is logical to assume that we will maintain that formulary position.

And we've been pretty effective at doing that historically, so I believe we'll be pretty effective at doing that again.

Rick Gonzalez: The second was when we looked at the ability to be able to use various methods to be able to activate consumers; we believe that the business was being underfunded in a way, both in the way it was being funded and the total amount that it was. And so we did some early work to determine whether or not that funding could drive incremental market growth, and it showed a positive result. And then when we saw that, we applied for significantly greater funding.

Rob anything you want to add just as a reminder, I mean, so we gave that we were using Europe as an analog but keep in mind that the U S system is very very different. This is why we gave you a range and so as we get closer to 23, obviously, we'll give more specific guidance on the U S. But we are communicating is more directional information based on the experience we saw with the ERP from mine there were four.

Our Biosimilars I came in market that time there'll be more biosimilars come in the U S markets Theres, a different level of competitive intensity.

Rick Gonzalez: And what you're actually seeing now, I think, is we are driving the market. We're bringing more patients into the category, and obviously because we have the leadership position from a market share standpoint. We get the vast majority of those pages; is there still some pent-up demand? I would tell you it's hard to believe at this point that there can be a lot of it, but there has to be some of it, right?

But also it's a very different payer landscape. So it's something to keep in mind.

Okay. Thank you.

Thank you Tim.

Operator next question please.

Thank you it comes from Gary Nachman with BMO capital markets. Your line is open Sir.

Thanks, Good morning, a couple on neuro that had some recent wins so first on the <unk> phase.

Phase III studies in MDT.

<unk> study you hit on the one and a half milligram dose, but not the three milligram dose it was close but not statistically significant.

Rick Gonzalez: Because remember, those practices will reopen in the US in the summer of 2020. So that's a long time to have pent-up demand, but it's impossible to tell one way or another. So I would say the majority of it is certainly being driven by us activating patients and retaining more patients. One of the other things we saw was the retention rate was relatively low once you activated a patient.

Will that matter to the FDA, maybe you could remind us what doses taken in the previous phase three.

And now that you have the full data set how do you think for AOR will stack up competitively in the <unk> space.

And then just quickly on migraine and a little bit more how the initial launch has gone for she left.

Is that the rolled into the Botox can you brought the offering.

Rick Gonzalez: And so we spent some time working with the team to figure out how you could retain those patients at a higher rate, meaning they come back. Unknown Speaker.......

Just your confidence about the reimbursement you said going into the first half of next year. Thanks.

Okay. This is Mike I'll take the first part of your question and then Jeff will take the second part of it.

Rick Gonzalez: So the data is very clear. If you look at the U.S. as an example, toxins and fillers are growing at a high rate of 30% of the market. We're growing at about the same rate, maybe a little bit lower on fillers, but about that rate on toxins.

Your question with respect to <unk> M D D.

In the study.

That you described the one five milligram dose.

<unk> met its endpoint and embed it with a highly statistically significant P value of <unk>.

Rick Gonzalez: When we look globally, the overall brands are growing at about that rate, and so I think this is a business that is sustainable over the long term. When we say across the decade, high single digits, obviously, if we keep this growth rate, the business is getting bigger and bigger. So, therefore, the percentage will come down a bit. But I tell you, I'm very optimistic about this market and our ability to be able to bring new assets into this market that can change the standard of care going forward as being able to drive market growth. It's very good.

005, so double-o five.

That's important and in terms of strength of evidence overall and weight of evidence overall and then as you point out.

In the three milligram arm and that same study.

Didn't hit significance, but we had a P value that was very small the nominal P value was zero seven.

Three.

If we round so when you look at that overall study.

Two our eye it clearly shows in effect an M D D now.

Now the second phase III study that we just ran out.

Did not reach statistical significance for either dose group, but there were favorable trends.

Chris: Thank you, Chris. Operator, we'll take the next question, please. Thank you. That comes from Tim Anderson with Wolf Research. Your line is open, sir. Thank you.

And across a number of comparisons that were nominal P values that were quite small and many of them were lower than.

Timothy Minton Anderson: Thank you. I wanted to ask a question on Humira in 2023, and I'm just really trying to nail down what's in that. Erosion Guidance of 45% plus or minus. That's sail erosion, not volume. I'm trying to think through what happened.

Zero five.

Uh huh.

I'll just remind the listeners that it's very common.

<unk> in depression studies, even with classes of medicines that have firmly established efficacy to have some studies that read out positive and some studies that are negative and so we think that overall package that we announced today is very strong and it's also important to keep in mind that we did have a prior study.

Timothy Minton Anderson: U.S. rebates, 2023, which is likely in the billions of dollars. Do you think you'll retain favorable formulary positioning even with Bossemler's, in which case, paying that rebate, but you also would have less volume? Do you think it becomes disadvantaged on formulary, in which case you pull back those billions of dollars? and that flows through to the bottom line. Me, I just wonder if your guidance on erosion is frankly [inaudible]. So Tim, this is Rick.

That was conducted several years ago.

That was also positive that demonstrated a statistically significant effect in that study looked at slightly different dosing there were dose ranges.

That were studied.

In that trial with titration. It was the upper two of the dose ranges that was significant but it did show both clinically meaningful and significant benefits. We had two positive studies and that's important because the way. These studies are typically looked at as an overall weight of evidence.

Timothy Minton Anderson: Maybe Rob and I will tag team this one. I'll start. I think the guidance we laid out of 45% or 48%, whichever is the latest number, plus or minus 10%, is still guidance that we feel pretty comfortable with. To your point about whether the bulk of it is price, it is.

Do you have a convincingly positive phase III study and is there other evidence with within the overall data package that is supportive and we feel comfortable that that is the case here.

Rick Gonzalez: Even if you look at the international markets, it's about one third, two-thirds, maybe slightly higher than, I mean, two-thirds of its price, one-third of its volume, and I would expect that we will maintain a significant part of the volume. Obviously, you know, we don't talk publicly about what our managed care strategy is. But what I would tell you is we're close enough now to that 23 timeframe that you would expect us to be starting the work to ensure formulary access for all of our products, and certainly Humira is one of those, for 2023.

And.

Lastly, what I'd say is if you look at the precedent and you look at other approvals findings like the ones that we described are not at all uncommon in fact, I think they're very common amongst approved agents in this space, including some of the more recent approvals in adjunct at M. D D like Brooks salted.

So overall, we think it is.

A strong package.

That has a viable regulatory pathway and we will stack up very.

Very nicely to competitors and we're going to begin those regulatory discussions shortly so with that I'll turn it over to Jeff. Yes. Thank you Mike look it's a meaningful opportunity for sure. When we look at the market sizes are about $60 million total prescriptions for the adjunctive MTBE market and that's very similar to the bipolar.

Rick Gonzalez: And, you know, I think it is logical to assume that we want to maintain that formulary position. And we've been pretty effective at doing that historically. So I believe we'll be pretty effective at doing it. Rob, anything you want to add?

Market that we operate in now so it's.

It's a very meaningful opportunity for us. So if you think about the what Mike was saying in terms of the competitive profile.

Robert A. Michael: Just as a reminder, I mean, we gave you that, we were using Europe as an analog, but keep in mind that, you know, the U.S. system is very, very different, which is why we gave you a range. And so, you know, as we get closer to 23, obviously, we'll give more specific guidance on the U.S., but what we were communicating was more, you know, directional information based on the experience we saw with Europe. Keep in mind, there were four biosimilars that came to the market at that time. There'll be more biosimilars coming to the U.S. market, so there will be a different level of competitive intensity.

I think we have to remember that while it's got a fairly low share.

<unk>, a very large very attractive which is why it's the fastest growing agents. So the efficacy is viewed very very nicely overall and I think that.

If approved this also has competitive efficacy a very gentle metabolic profile minimal weight gain very tolerable and also very simple dosing for the psychiatrist in the in the primary care doctors that look at this so when you start to see the potential for an <unk>.

<unk> like <unk>, that's got the full spectrum across bipolar disease.

A mania mixed episodes in depression, and then the adjunctive depression indication.

Jim: Thank you, Jim. Operator, next question, please. Thank you. This comes from Gary Nachman with BMO Capital Market. Your line is open, sir.

If approved it will be very attractive. So we anticipate a nice catalyst here and certainly a nice add to <unk> overall profile.

Gary Jay Nachman: Thanks, good morning. A couple on neuro that had some recent wins.

Jeff you want to cover the second question, Yes, perfect. The second question you had was.

Was <unk> and <unk>.

Gary Jay Nachman: So first on VRELAR, the phase three studies in MDD, in one study, you hit on the one and a half milligram dose but not the three milligram dose. It was close, but not statistically significant. So will that matter to the FDA? Maybe, you know, you could remind us what doses hit in the previous phase three? And now that you have the full data set, how do you think VRELAR will stack up competitively in the MDD space?

Very early we just introduced the product with our full commercial promotion as I mentioned in my prepared remarks, we have now as of this quarter a dedicated migraine salesforce, which shows you how important we think that this franchise is and what we can do with this franchise. So we have an entire sales team out.

There that is launching <unk> and now also focused on <unk> and the early feedback has been very strong what we hear qualitatively from our field and certainly from our research in the first few weeks of launch is first the simplicity and strength of Q Lipton for prevention.

Gary Jay Nachman: And then just quickly on migraine, you know, a little bit more about how the initial launch went for Tulipta and how that has been rolled into the Botox and Ubrelvi offering and just your confidence about the reimbursement you said going into the first half of next year. Thanks. Okay, this is Mike.

We see very very nice response to our efficacy data, which as Mike has said before and Ive said before is on the very high end of preventative performance. So 60% of patients in our trials achieved a greater than 50% reduction in migraine days, which is viewed as very significant and almost <unk>.

Mike: I'll take the first part of your question, and then Geoff will take the second part of your question. With respect to Braylor MDD, in the study that you described, the 1.5 milligram dose met its endpoint, and it met it with a highly statistically significant p-value of.005, so.005. And that's important in terms of the strength of the evidence overall and the weight of the evidence overall. And then, as you point out, in the 3 milligram arm of that same study, we didn't hit significance, but we had a p-value that was very small. The nominal p-value was.073, if we round it off.

30%.

We control, 100% decrease in their migraine days. So that's a very compelling in terms of this Q lifted power also physicians like the simple everyday dosing once a day and so things are are.

Are quite strong in terms of our early qualitative feedback. So we do obviously anticipate that the majority of our of our prescriptions will be.

Bridge prescriptions until our we get the full ramp of our market access, which as I mentioned, we're quite confident by the first half of the year, we should ramp similar to you broadly where ultimately as you remember we achieved about a 90% access in the U S. So quite good early feedback on the launch.

Mike: So when you look at that overall study, it clearly shows an effect in MDD. Now, the second phase 3 study that we just read out did not reach statistical significance for either dose group, but there were favorable trends, and across a number of comparisons, there were nominal p-values that were quite small, and many of them were lower than.05. And I'll just remind the listeners that it's very common in depression studies, even with classes of medicines that have firmly established efficacy, to have some studies that read out positive, and some studies that are negative.

And again, we think that the three assets together are a unique competitive positioning for abbvie.

Thank you Gary Operator next question please.

Our next question is from Matthew Harrison with Morgan Stanley. Your line is open Sir.

Great. Good morning, Thanks for taking the questions I guess two for me so I wonder if I could just follow up on.

<unk> I'm curious, obviously you have a different strategy than your competitor when it comes to the prophylactic market I'm. Just wondering how you think where your sources of patients are going to come from are you expecting more transitions from injectable or do you think theyre going to be more de novo patients and if you could just talk about the.

Mike: And so we think that the overall package that we announced today is very strong. And it's also important to keep in mind that we did have a prior study that was conducted several years ago that was also positive, that demonstrated a statistically significant effect. And that study looked at slightly different doses. There were dose ranges that were studied in that trial with titration.

A little better than that.

On <unk> could you just talk about.

Your confidence in the data there obviously there was some inflammation there, though it did seem self limiting I'm just curious how you think about that and how you think about that impacting the profile because obviously in other gene therapy products in the eye inflammation.

Mike: It was the upper two of the dose ranges that was significant, but they did show both a clinically meaningful and significant benefit. So we had two positive studies, and that's important because the way these studies are typically looked at is by an overall weight of evidence. Do you have a convincingly positive phase 3 study, and is there other evidence within the overall data package that is supportive? And we feel comfortable that that is the case here.

It has sometimes a proven to be pretty significant as a long term supply. Thanks.

Yes, I'll take the first one thanks, so in terms of the source of business, we think that <unk>.

Is going to source business from from two primary areas first is.

The big headache specialists, the big Neurologists, we think absolutely from a research and feedback that youll start to see an early trade off of the injectable maps in favor of the oracles and certainly in favor of <unk> I think that this is this is viewed as very attractive in many in many cases some <unk>.

Mike: And lastly, what I'd say is, if you look at the precedent and you look at other approvals, findings like the ones that we described are, So, overall, we think it is a strong package that has a viable regulatory pathway, and we'll stack up, you know, very nicely to competitors, and we're going to begin those regulatory discussions shortly. With that, I'll turn it over to Geoff.

We'll have spontaneously highlighted while it looks like a very strong mab and in a single oral pill. So that's a source of business in terms of market share trade off I think the others. Other insight that we have from the market is that we are going to a calling on a substantial amount of high prescribing.

Mike: Look, it's a meaningful opportunity for sure. When we look at the market sizes, about 60 million total prescriptions for the adjunctive MDD market, and that's very similar to the bipolar market that we operate in now. So, it's a very meaningful opportunity for us. If you think about what Mike was saying in terms of the competitive profile, I think we have to remember that while it's got a fairly low share, Braylor is very attractive, which is why it's the fastest growing agent.

Primary care physicians, who don't write a lot of maps, but they certainly right a lot of generic <unk>.

<unk> and some other older agents and so we also see that we have a unique opportunity and in a wider audience to source from physicians that really don't lean towards the maps because of the injectable nature of those et cetera. So we think we're going to have a good balance between those two sources of business and and that's quite attractive for us right now.

Yeah.

So this is Mike I'll take the question regarding Regenesis, we're very encouraged by the recent data if we take a step back and look at the program overall they have.

Mike: So, the efficacy is viewed very, very favorably overall, and I think that, you know, if approved, this also has competitive efficacy, a very gentle metabolic profile, minimal weight gain, very tolerable, and also very simple dosing for the psychiatrists and the primary care doctors that look at this. So, when you start to see the potential for an agent like Braylor that's got the full spectrum across bipolar disease in terms of mania, mixed episodes, and depression, and if approved, it will be very attractive. So we anticipate a nice catalyst here and certainly a nice add to Raylar's overall. If you want to cover the second question, Yeah, perfect.

Very strong efficacy data already demonstrated with sub retinal delivery now that's an AR or procedure, but it gives clear.

Proof of concept.

For the approach and shows that we can get durable control and.

In that component of the program is already in phase III and then the more recent data that were presented.

Just about a month ago.

Several weeks ago looked at Super Choroidal deliveries. So that is a delivery method that can be done in office.

It's a specialized form of injection, but it is a form of injection.

And that is also showing very good promise, we're already seeing signs of efficacy in the first cohort.

Which is the lowest dose cohort, which quite frankly is sooner than we expected to see them.

Geoff: The second question you had was, uh, QLIPDA. And QLIPDA, it's very early. We just introduced the product with our full commercial promotion. As I mentioned in my prepared remarks, we now, as of this quarter, have a dedicated migraine sales force, which shows you how important we think that this franchise is and what we can do with this franchise. So we have an entire sales team out there that is launching QLIPDA and is now also focused on Ubrelvi.

Before that study.

Had started to deliver results in the Tolerability.

Is very good.

If one looks at the inflammation.

As reported in the Regenesis trials, it's very different in its nature and its severity than that that has been seen with other agents, it's principally anterior chamber exclusively anterior chamber Theres no vasculitis no.

More significant inflammation.

It is readily treated.

With topical steroids.

Geoff: And the early feedback has been very strong. What we hear qualitatively from our field and certainly from our research in the first few weeks of launch is, first, the simplicity and strength of QLIPDA for prevention. We see a very, very nice response to our efficacy data, which is, Mike has said before and I've said before, on the very high end of preventative performance. So 60 percent of patients in our trials achieved a greater than 50 percent reduction in migraine days, which is viewed as very significant.

And.

Generally resolves without.

Without any difficulty in and in fact quite rapidly.

Also important to remember that there's no prophylactic steroids being used here other approaches have required that so these are patients who have no prophylaxis upfront and are responding to.

That's often a brief course of <unk>.

Topical steroids and the reason why there's no prophylactic steroids, given us or Theyre, just not felt to be needed given the very <unk>.

<unk>.

Nature of the inflammation is being observed so we're very confident with it and again, we feel it is qualitative qualitatively very different.

Geoff: And almost 30 percent have complete control, a 100 percent decrease in their migraine days. So that's very compelling in terms of this QLIPDA power. Also, physicians like the simple, everyday dosing once a day, and so things are quite strong in terms of our early qualitative feedback. So we do obviously anticipate that the majority of our prescriptions will be bridge prescriptions until we get the fuller ramp of our market access, which, as I mentioned, we're quite confident by the first half of the year, we should ramp up similar to Ubrelvi where, as you remember, we achieved about 90 percent. So, quite good early feedback on the launch. And again, we think that the three assets together are a unique competitive position.

Then what has been seen in other agents in and we've obviously talked to retinal specialists as well who are quite familiar with the program.

The views we've heard from them are supportive of what I just described.

Thank you Matthew Operator next question please.

Yes.

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

Thank you I have a few questions a couple of follow ups, but how would you describe the nature and the tone of conversations with FDA regarding <unk> New label NRA would you say youre pleased with how things are going is the outcome unclear to abbvie at this juncture or is the outcome obvious sent in.

Align with what the FDA had in its statement in September. So that's the first question second question to my knowledge <unk> has shown superiority to placebo, but not generics in M. D. D. So how would abbvie establish it as a leading MDT agent given the presence of lower cost alternatives.

Geoff: Thank you, Gary. Operator, next question, please. Our next question is from Matthew Harrison with Morgan Stanley. Your line is open. Uh, great. Good morning. Thanks for taking the questions. I guess there are two for me. So one, if I could just follow.

And then lastly, any thoughts on the solid tonne.

Matthew Harrison: Great. Good morning.

Matthew Harrison: Thanks for taking the questions. I guess two for me. So one, if I could just follow up on CGRP. I'm curious. Obviously, you have a different strategy than your competitor when it comes to the prophylactic market. I'm just wondering where your sources of patients are going to come from. Are you expecting more transitions from injectables? Or do you think they're going to be more de novo patients? And if you could just talk about that a little bit.

Acquisition relative to its closing thank you.

Okay. This is Mike I'll start and then Rick will take the question regarding solar time.

With respect to the tone of conversations with the FDA for <unk> I would describe them as productive with respect to your <unk>.

Question, specifically about the <unk> label those those those discussions are productive as well.

I would assume the base case is is what they announced.

Matthew Harrison: And then, secondly, on Regenexx, could you just talk about your confidence in the data there? Obviously, there was some inflammation there, though it did seem self-limiting. I'm just curious how you think about that and how you think about that impacting the profile, because obviously, in other gene therapy products in the eye, inflammation has sometimes proven to be pretty significant as a long-term sequelae. Thanks. Yeah, I'll take the first one.

And separately.

Back in early September, but we are working through the specifics of how that translates.

Into labeling language and I would characterize the discussions around the other indications as being a <unk>.

Very productive and very positive as well and so.

As I mentioned earlier in this call we remain very confident in the files for those.

Mike: Thanks. So in terms of the source of business, we think that Q-Lypta is going to get business from two primary areas. First is, you know, the big headache specialist, the big neurologist. We think, absolutely, from our research and feedback, that you'll start to see an early trade-off from the injectable MABs in favor of the orals and certainly in favor of Q-Lypta. I think that this is viewed as very attractive.

For those new indications for all three of them.

With respect of railcar.

<unk> superiority studies are not typically done in this space Theyre very challenging it is challenging to show an impact even with established classes period in major depressive disorder, and particularly in this space because.

This is the adjunct treatment of major depressive disorder. So these are patients who aren't responding to.

Two the current therapies and require an add on and atypical anti psychotics with pharmacology similar to <unk> or one of the most commonly used agents in this space. So we think the very strong data that we have.

Mike: In many cases, some people have spontaneously highlighted, wow, it looks like a very strong MAB in a single oral pill. So that's a source of business in terms of market share trade-off. I think the other insight that we have from the market is that, you know, we are going to call on a substantial amount of high prescribing primary care physicians who don't write a lot of MABs, but they certainly write a lot of generic topiramate and some other older agents.

From the study that we described and the fact that we have prior supportive evidence as well from from the earlier study will position it very well to be got to be competitive in that marketplace and Steve. It's Jeff just that just to build on Mike's point I mean, if you think about the size of rail are now approaching $1 $8 billion as it is a two and a half share in.

Mike: And so we also see that we have a unique opportunity to reach a wider audience to source from physicians that really don't lean towards MABs because of the injectable nature of those, etc. So we think we're going to have a good balance between those two sources of business, and that's quite attractive. So, this is Mike.

Of the antipsychotic market. So it's a low share high value and growth area. So when you think about.

Most of our most of our business is already stepped through in some cases, one or two of the generics. The problem is that these patients are so fragile. They just they just don't respond well so we would still anticipate that.

Mike: I'll take the question regarding Regenexx. We're very encouraged by the recent data. If we take a step back and look at the program overall, they have very strong efficacy data already demonstrated with subretinal delivery. Now, that's an OR procedure, but it gives clear proof of concept for the approach and shows that we can get durable control.

With the approval with new approval for AMD, you are still going to have step therapy and other approaches in the marketplace, but that there is still a very very.

Very nice commercial opportunity there that's just the way the markets work today.

Alright. Thanks.

So this is Rick.

Steve unsold of time as you know we obviously.

Mike: And that component of the program is already in phase three. Unknown Executive, Mohit Bansal, Carson Wong, Perry Siatis, Marcella Pinella, AbbVie. It is readily treated with topical steroids and, you know, generally resolves without any difficulty and, in fact, quite rapidly. And it's also important to remember that there are no prophylactic steroids being used here, although other approaches have required them. So these are patients who have received no prophylaxis up front and are responding to what's often a brief course of topical steroids.

Once the our intention to acquire the company and submitted for approval, we did receive a second request.

Maybe just to frame a bit.

Why were interested in this area.

Turning to look at this market, where the third major leg of the stool in aesthetics is body contouring and this is a good fit with Kohl's faulting.

And Paul tone, obviously cool sculpting is focused more on reduction of fat in targeted areas.

Coal tones more focus on the area of enhancing muscle tone.

Mike: And the reason why there are no prophylactic steroids given is that they're just not felt to be needed given the very mild nature of the inflammation that's being observed. So we're very confident with that. And again, we feel it's qualitatively very different from what has been seen in other agents. And we've obviously talked to retinal specialists as well, who are quite familiar with the program. And the views we've heard from them are supportive of what I.

And specific areas.

This particular asset is designed to reduce cellulite, we don't have a position in cellulite now.

So theres not any kind of competitive overlap in that area, having said that we are responding to the FTC's inquiry, we believe that's going reasonably well. So we would expect this to be resolved at some point here in the future I can't tell you a specific date, but I would expect it to.

A positive outcome.

Matthew: Thank you, Matthew. Operator, next question, please. Thank you. Our next question is from Steve Scala with Cowan. Your line is open, sir. Thank you.

Over a period of time here.

Thank you Keith operator next.

Next question please.

Thank you. Our next question is from the mill Divan with Mizuho Securities. Your line is open.

Great. Thanks, so much for taking my question. So just.

Steve Scala: Thank you. I have a few questions, a couple of follow-ups, but how would you describe the nature and the tone of the conversations with FDA regarding Renvoke's new label, NRA? Would you say you're pleased with how things are going?

One more just on <unk> following up on the other comment I think before you talked about it as being as maybe it's a multibillion dollar opportunity and MDT.

Is that still sort of the lines, you're thinking now that you're you've seen the data.

Steve Scala: Is the outcome unclear to AbbVie at this juncture, or is the outcome obvious and in line with what the FDA said in its statement in September? So that's the first question. Second question, to my knowledge, Raylar has shown superiority to placebo but not generics in MDD. So how would AbbVie establish it as a leading MDD agent, given the presence of lower-cost alternatives? And, lastly, any thoughts on the Soliton acquisition relative to its closing? Thank you. Okay, this is Mike. I'll start.

Today, and then the second one just going back to <unk>.

It sounds like you're still pretty confident on.

On the products outlook, but im just curious if thats changed any of your sort of priorities as you think about business development specifically in immunology. So the need for you to maybe look at other oral agents that might be in development there.

Are you thinking about the broader PD.

BD landscape there. Thank you.

Yes, I think if you look at the as I highlighted.

That.

The market sizes are roughly the same however, the competitive context is quite a bit different than the competitive set is a little bit different. So we view it again as a as an important an important incremental opportunity that even with with low incremental share that we can we can drive railcar to that multibillion dollar.

Mike: And then Rick will take the question regarding Soliton. You know, with respect to the tone of conversations with the FDA from Randolph, I would describe them as productive. With respect to your question specifically about the RA label, those those discussions are productive as well. You know, I would assume the base case is what they announced conceptually back in early September.

Guidance that we look at it we do think it's an incremental catalyst and <unk>.

Exciting approach if it were to be approved.

So this is Mike I'll take the Rainbow question.

Mike: But we are working through the specifics of how that translates into labeling language. And I would characterize the discussions around the other indications as being very productive and very positive as well. Because of RALAR, head-to-head superiority studies are not typically done in this space. They're very challenging.

So as you point out yes, we are very confident in <unk> as a molecule overall, we've talked about.

The progress on the <unk> indication and our confidence in the new indications both those that are under review.

And indications, where we have data, but have not yet submitted like the IBD indications and so we feel that it's going to be an important part of our portfolio.

Mike: It is challenging to show an impact even with established classes, period, in major depressive disorder, and particularly in this space because this is an adjunctive treatment for major depressive disorder. So these are patients who aren't responding to the current therapies and require an add-on, and atypical antipsychotics with pharmacology similar to RALAR are one of the most commonly used agents in this space. So we think the very strong data that we have from the study that we described and the fact that we have prior supportive evidence as well from the earlier study will position it very well to be competitive in that. And Steve, it's Geoff.

The treatment armamentarium going forward.

Having said that immunology is always an area, where we are scouring the landscape to look to look for the best opportunities. So I wouldn't say, it's changed our focus in any way or changed our approach.

But we will continue to look for novel therapies that can raise the bar on the standard of care across a number of areas. The current indications, where we are already planning and new indications.

Geoff: Just to build on Mike's point, I mean, if you think about the size of Raylar now, approaching $1.8 billion, it has a two and a half share in terms of the antipsychotic market. So it's a low share, you know, high value and growth area. So when you think about most of our business, most of our business is already stepping through, in some cases, one or two of the generics. The problem is that these patients are so fragile; they just don't respond well.

That have fewer treatment options areas like lupus and scleroderma so.

The <unk> situation has not changed that strategy in any way.

Thanks, Shlomo operator, we'll take the next question please.

Thank you Ms from Ronny Gal with Bernstein. Your line is open Sir.

Hi, Good morning, and thank you for taking my questions I've got a clarification and then a couple of questions.

First Rick you kind of mentioned regarding alphatec about the acceleration clauses and I just wanted to clarify if this is on district court decision. Our appeal given the timing is actually mix quite a bit of difference there.

The two questions I have first our interchange ability for Humira do you think this will matter in the marketplace. We are hearing different things from the large payers.

Geoff: So we would still anticipate that, you know, with the new approval for AMD, you're still going to have step therapy and other approaches in the marketplace, but that there's still a very, very, very nice commercial opportunity. That's just the way the markets work today. So this is Rick, Steve.

What is your take here and what it's been like Abbvie position about that and the second question is the loss of dress, we've seen from D. C regarding the.

The infrastructure Bill does not include a reduction of the out of pocket costs in Medicare we're still hearing from context still might be the case that these are still included if you can comment on this issue do you expect it to be included and the impact it might have on average business.

Rick Gonzalez: On Soliton, you know, as you know, we obviously announced the intention to acquire the company and submitted it for approval. However, we did receive a second request. Maybe just to frame a bit why we're interested in this area. You know, we tend to look at this market where the third major leg of the stool in aesthetics is body contact. And this is a good fit with Cool Sculpting and Cool Tone. Obviously, Cool Sculpting is focused more on the reduction of fat in targeted areas. And Cool Tone's more focused on the area of enhancing muscle tone. This particular asset is designed to reduce cellulite.

Okay.

So Ronny this is Rick.

Obviously these agreements that we have with the other biosimilar players are confidential, so I'm not going to I'm not going to delve into some of the specifics around those what I would tell you is what I've said before I mean, we are highly confident in our position with this IP. This I've been challenged multiple times.

And we have a high degree of confidence that we will prevail.

So I think it's it's obviously a hypothetical scenario.

But I don't.

I wouldn't give it a lot of merit.

Second one interchangeable humira is as we've discussed previously.

Rick Gonzalez: We don't have a position in cellulite now, so there's not any kind of competitive overlap in that area. Having said that, we are responding to the FTC's inquiry. We believe that's going reasonably well, so we would expect this to be resolved at some point here in the future. I can't tell you a specific date, but I would expect to have a positive outcome over a period of time here.

When we built the erosion model that we described a couple of years ago, or certainly a year and a half or so ago. We did assume at that point that they were going to be two interchangeable biosimilars.

It does matter from a pricing standpoint to some extent so I think it will have an impact, but it's consistent with what we had assumed.

And so we've essentially taken that into consideration in the forecast that we provided you in the estimates that we provided you.

<unk>.

On drug pricing in the U S.

Look I would say, it's a very fluid situation, it's a little difficult to.

Steve: Thank you, Steve. Operator, next question, please. Thank you. Our next question is from Vamil Divan with Mizzou.

Who truly understand exactly where we are.

You are correct. If you look at this framework that came out yesterday.

Vamil Kishore Divan: With Mizzou Securities, your line is open. Great, thanks so much for taking my question. So just maybe one more, just on Raylar, following up on the other comments. I think before you talked about this being maybe a sort of multi-billion dollar type opportunity in MDD, is that still sort of the lines you're thinking now that you've seen the data that you disclosed today? And then the second one, just going back to Renvoke, obviously sounds like you're still pretty confident about that product's outlook.

Essentially talked about repeal of the rebate.

Rule.

Being eliminated.

And it didn't talk about much else.

So.

The things that we're focused on and things that we think would make a difference our out of pocket cost for patients.

And.

Making them lower for Medicare patients, making them something that they can spread over a period of time 12 months period of time to make their cash flow.

Easier to deal with.

And as we've said before we think industry could play a role in that.

As one of the participants and we would hope that we will get back to that because I think we think that is the most fundamental issue is reducing the out of pocket cost for these patients.

Thank you Ronny operator next question please.

Vamil Kishore Divan: But I'm just curious if that's changed any of your sort of priorities as you think about business development, specifically in immunology, sort of the need for, you know, maybe look at other oral agents that might be in development there, just sort of how you're thinking about the broader BD landscape there. Jeff?

Thank you. Our next question is from Geoff Meacham with Bank of America. Your line is open Sir.

Great Hey, guys. Thanks, so much for the question.

I just have two quick ones probably for Mike the.

To follow up on <unk> I know, it's been asked a lot, but you have a number of labeling scenarios that could play out just with respect to dose or TNF requirement or language on black box or any maybe any limit on duration is there one of those items that has more of an impact than the others I'm just trying to think about what informs your assumptions.

Jeff: Yeah, I think if you if you look at the, as I highlighted, that, you know, the market sizes are roughly the same. However, the competitive context is quite a bit different, and the competitive set is a little bit different. So we view it again as an important, important incremental opportunity that even with a low incremental share that we can drive Raylar to that multi billion dollar guidance that we looked at. We do think it's an incremental catalyst and an exciting approach if it were to be approved. So this is Mike.

And the second question on cystic fibrosis, when you look to the upcoming.

Roof of concept data readout is there a minimal effect size or sort of profile that youre looking for that would justify moving to a larger scale phase III. Thanks, so much.

So I'll take the RIN vote question first and then make some comments on CF, what I would say about <unk>.

Is our assumptions around.

The labeling at a base case are based on what the agency announced in their safety communication in September so that's principally updates.

Mike: I'll take the RINVOQ question. So, as you point out, yes, we are very confident in RINVOQ as a molecule overall. We've talked about the progress on the RA indication and our confidence in the new indications, both those that are under review and indications where we have data but have not yet submitted, like IBD. And so we feel that it's going to be an important part of our portfolio and the treatment armamentarium going forward.

To the black box.

Earnings that all of these agents have and in fact.

All agents in immunology have some degree of this that treats similar conditions to Rainbow for example, the TNF some of the same but not all of the same warnings so updating.

You know that that section of the label as part of our base case and then the restriction.

And that the agency described for certain patients around TNF inadequate response forms our base case and those are the two factors that we're considering.

Mike: You know, having said that, immunology is always an area where we are scouring the landscape to look for the best opportunities. So I wouldn't say it's changed our focus in any way or changed our approach, but we will continue to look for novel therapies that can raise the bar on the standard of care in a number of areas. Current indications where we are already playing and new indications, you know, that have fewer treatment options, areas like lupus and scleroderma. So the RINVO situation has not changed that strategy in any way.

We would not anticipate any limit in duration of therapy for example.

And.

The question dose principally.

Applies to the atopic dermatitis filed because we have just a single dose in the other files in the files.

That are in the rheumatology space and we feel confident about both doses in terms of the benefit risk that we've demonstrated in that <unk> atopic dermatitis program. So it's really those two dimensions.

Vamil: Thanks, Vamil. Operator, we'll take the next question, please. Thank you. It was from Ronnie Gall with Bernstein. Your line is open, sir.

And how those translate into specific language in Iraq, and then of course, how they translate to the other indications because tnf's or notwithstanding of care and all indications are not used in atopic dermatitis. So then it's how do those concepts get get.

Ronnie Gall: Good morning, and thank you for taking my questions. I have a clarification question and then a couple of questions. First, Rick, you kind of mentioned regarding Alba Tech the acceleration clauses, and I just want to clarify if this is a district court decision or appeal. Given the timing, it actually makes quite a bit of difference. Then the two questions I have first are about interchangeability for Humara.

Translated into the label in other indications those are the principal dimensions that we're looking at when we think about.

About those programs and again, we feel very confident in the files that we've put forward and feel very good about how discussions have have gone to date.

Ronnie Gall: Do you think this will matter in the marketplace? We are hearing different things from the large payers. What is your take here, and what is it going to add to this position? And the second question is that the last address we've seen from D.C. regarding the infrastructure bill does not include a reduction of out-of-pocket costs in Medicare. We're still hearing from context.

With respect to see App and what we're looking for we're looking for something that has.

Demonstrated.

Benefit compared to.

Sure.

What's already out there or what will be out there at the time, our agents come to market, obviously, the principal competitor the only.

Group with a marketed product.

Right now in this space is for tax and so that's what we would be benchmarking ourselves against I would say and at an absolute minimum you'd have to have efficacy that was just as good with other meaningful advantages, but what we're striving for is something that has an efficacy advantage.

Ronnie Gall: This might still be the case that it's still included. If you can comment on this issue, do you expect it to be included and the impact it might have on AbbVie? So Ronnie, this is Rick.

Rick Gonzalez: On Allotech, obviously, these agreements that we have with the other biosimilar players are confidential, so I'm not going to delve into some of the specifics around those. But what I would tell you is what I said before. I mean, we are highly confident in our position with this IP. This IP has been challenged multiple times, and we have a high degree of confidence that we will prevail. So I think it's. It's obviously a hypothetical scenario, but I wouldn't give it a lot of merit.

A small number of absolute F&B one points.

A small number of absolute FCB wants might not sound like much but it can translate into real benefit for patients in this disease.

Thank you Jeff Operator next question please.

Thank you. Our next question is from Luisa Hector with Brian Burke. Your line is open ma'am.

Rick Gonzalez: Second, on interchangeable humeras, as we discussed previously, when we built the erosion model that we described a couple of years ago, or certainly a year and a half or so ago, we did assume at that point that there were going to be two interchangeable biosimilars. It does matter from a pricing standpoint to some extent, so I think it will have an impact on drug pricing in the U.S. Look, I would say it's a very fluid situation.

Thank you good morning, Im sorry, yes, I still have a couple more on wind.

I just wanted to understand whether the <unk>.

Enable update.

Hey.

And then the approvals and the new indications.

Unfortunately, what happened on the same day or at school.

Alright update.

And then there's still a bit more what you've done for the new indications.

And then looking on to the U E filing.

Rick Gonzalez: It's a little difficult to truly understand exactly where we are. You are correct. If you look at this framework that came out yesterday, it essentially talked about repealing the rebate rule being eliminated, and it didn't talk about much else.

The acceptance of that filing.

In any way dependent on the.

Enable thing results fast or.

To be accepted as asylum Walgreens.

Both are still outstanding.

This is Mike I'll take those two questions so with respect.

Rick Gonzalez: So, look, the things that we're focused on and things that we think would make a difference are out-of-pocket costs for patients and making them lower for Medicare patients, making them something that they can spread over a period of time, a 12-month period of time, to make their cash flow easier to deal with. And as we said before, we think the industry could play a role in that as one of the participants. And we would hope that we will get back to that because I think we think that is the most fundamental issue, reducing the out-of-pocket cost of

To the ongoing reviews, what I would say is the discussions around the <unk> label update and the new indications that are under review are going on simultaneously.

And.

There is some level of interdependence in other words, we need to understand where the <unk> label will land because some of those elements like the warnings and precautions will translate over to the other indications because in the U S. You get one label for the molecule.

Ronnie: Thank you, Ronnie. Operator, next question, please. Thank you. Our next question is from Geoff Meacham with Bank of America. Your line is open, sir.

That applies across all of the indications.

So theres some interdependency.

Thats why getting the <unk> label.

Label update resolved as is a gating factor whether it can happen on the same day or in close succession I think it's too early to call what that find level of detail, but we would expect.

Geoff Meacham: Great, hey guys, thanks so much for the questions. I just have two quick ones, and probably for Mike.

Geoff Meacham: The follow-up on RINVOC, I know it's been asked a lot, but you have a number of labeling scenarios that could play out just with respect to dose or TNF requirement or language on the black box or any limit on duration. Is there one of those items that has more of an impact than the others? I'm just trying to think about what informs your. And the second question on cystic fibrosis, when you look at the upcoming proof-of-concept data readout, is there a minimal effect size or sort of profile that you're looking for that would justify moving to a larger scale phase 3?

The psoriatic arthritis, and atopic dermatitis filings to do follow in a in a very reasonable timeframe. After that label update as I mentioned, we are adding new data to the ankylosing spondylitis submission, which is the smallest of the three indications and so that one.

It might be on a slightly different timeframe as the agency reviews, those new data with respect to the USEC filing the <unk> label update is not on critical path to file acceptance.

Geoff Meacham: So I'll take the RINVOQ question first and then make some comments on CF. You know, what I would say about RINVOQ is, you know, our assumptions around the labeling at a base case are based on what the agency announced in their safety communication in September. So that's principally updates to the black box warnings that all of these agents have.

But what the agency looks at when they look at file acceptance is happy provided sufficient data for them to evaluate the file is it in an appropriate format that they can review are there any significant deficiencies and of course, we're very confident.

Mike: And in fact, all agents in immunology have some degree of this that treats similar conditions to RINVO, have some of the same, but not all of the same. So, updating that section of the label is part of our base case, and then the restriction that the agency described for certain patients around TNF and adequate response forms our base case, and those are the two factors that we're considering. You know, we would not anticipate any limit in duration of therapy, for example, and, you know, the question of dose principally applies to the atopic dermatitis file because we have just a single dose in the other files, in the files that are in the rheumatology space, and we feel confident about both doses in terms of the benefit-risk that we've demonstrated in that atopic dermatitis program.

In the file that we've submitted so we would not in any way anticipate any challenges there and they are a safety label update is not a gating factor for that filing.

While acceptance.

Thank you Lisa Operator next question please.

Thank you. Our next question is from Chris Raymond with Piper Sandler Your line is open.

Hi, Good morning. This is Alex <unk> on for Chris Thanks for taking the question.

No.

The 95, one in Parkinson's.

Just hoping you could put some of that safety findings from the phase III trial in context.

Particularly the imbalanced and hallucination psychosis.

22% I think treatment discontinuation rate.

Basically just how did that safety profile stack up against your expectations.

Mike: So, it's really those two dimensions and how those translate into specific language in RA, and then, of course, how they translate to other indications. Because TNFs are not the standard of care in all indications. They're not used in atopic dermatitis, for example.

How does this translate into real world use of like Taiwan.

So this is Mike I'll take that question with respect to the data for 95 one.

Pleased with the data Theres very strong efficacy and the safety is within our expectations. It matches, our expectations across essentially all important areas.

Mike: So, then it's, you know, how do those concepts get translated into the label in other indications? Those are the principal dimensions that we're looking at when we think about those programs, and again, we feel very confident in the dossiers that we've put forward and feel very good about how discussions have gone so far. With respect to CF and what we're looking for, we're looking for something that has demonstrated, you know, benefit compared to CF. What's already out there or what will be out there at the time our agents go to market. Obviously, the principal competitor, the only group with a marketed product right now in this space, is Vertex.

What's important to keep in mind is this agent.

It delivers transformative benefit to patients who have extremely difficult to control Parkinson's disease.

Through through other measures and to have a very very difficult time controlling their disease for example, with oral or with other approaches and so the overall picture has to be looked at in that context with respect to treatment discontinuation, what I would say is the treatment discontinuation.

The rate of that overall is very similar to what you see with similar devices with insulin pump like devices used across a range of conditions. Most of these were driven by either.

Geoff: And so that's what we would be benchmarking ourselves against. I would say at an absolute minimum, you'd have to have efficacy that was just as good with other meaningful advantages. But what we're striving for is something that has an efficacy advantage of a small number of absolute FEV1 points. A small number of absolute FEV1 points might not sound like much, but it can translate into real benefit for patients in this disease.

Local tolerability issues like injection site reactions, which were principally erythema.

<unk> technical usability issues because these are older patient populations with limited mobility and dexterity in many cases, and there's always a subset of patients who find that they have difficulty using any device under those circumstances, but again those rates of discontinuation of <unk>.

Luisa Caroline Hector: Thank you, Geoff. Operator, next question, please. Thank you. Our next question is from Luisa Hector with Barenburg. Your line is open, ma'am.

Similar to what you see.

With with similar insulin pump like devices and keep in mind. This is a very very large population. This advanced Parkinson's population only a very small proportion of which currently get advanced treatments because it is so limited in how they can be delivered we think theres a big opportunity here.

Mike: This is Mike. I'll take those two questions. So with respect to the ongoing reviews, what I would say is the discussions around the RA label update and the new indications that are under review are going on simultaneously, and there is some level of interdependence. In other words, we need to understand where the RA label will land because some of those elements, like the warnings and precautions, will translate over to the other indications because in the US, you get one label for the molecule.

And that treatment discontinuation rate doesn't change than it is in line with our expectations.

With respect to hallucinations.

No that that has on mechanism.

Levodopa and carbon delta and its essentially evidenced that we are delivering levodopa and carbon delta in a way that is more effective.

Mike: That applies across all of the indications, so there's some interdependency. That's why getting the RA label update resolved is a gating factor. Whether it could happen on the same day or in close succession, I think it's too early to call at that fine level of detail.

Then can be done through other methods and it's something that can be titrated and something that can be managed and what I would point to is in the other direction. The oral group the control group that got oral levodopa and carbon Delta had more falls.

Mike: But we would expect the psoriatic arthritis and atopic dermatitis filings to follow in a very reasonable timeframe after that label update. As I mentioned, we're adding new data to the ankylosing spondylitis submission, which is the smallest of the three indications. And so that one might be on a slightly different timeframe as the agency reviews those new data.

And that.

Two our eye shows.

A lower degree of control, which matches the clinical efficacy data because we know falls are common.

<unk> in Parkinson's disease patients so.

We need to keep that in mind and with the efficacy that we've delivered.

These are all.

Very attractive profiles and ones that will translate into significant real world use when we look at how this will impact your old use again and keep in mind that that it's a very broad population only a very small segment of which can access the kinds of therapies that they that they need to control their disease therapies like <unk>.

Mike: With respect to the UC filing, the RA label update is not on the critical path to file acceptance. What the agency looks at when they look at file acceptance is whether you have provided sufficient data for them to evaluate the file. Is it in an appropriate format that they can review? Are there any significant deficiencies? And, of course, we're very confident in the file that we've submitted. So we would not, in any way, anticipate any challenges there. And the RA safety label update is not a gating factor for file acceptance.

<unk>, which is transformative, but takes us surgical gastric tubes actually threaded into the small doll to get deep brain stimulation and other types of measures. So this is a much less invasive.

Approach that delivers very strong efficacy and we think that will translate very very effectively until into the real world.

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

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

That will come from Josh humor, with Evercore Evercore ISI. Your line is open Sir.

Christopher Joseph Raymond: Thank you. Our next question is from Chris Raymond with Piper Sandler. Your line is open. Hi, good morning. This is Allie Bratzelon for Chris.

Alright. Thanks for squeezing me in can you talk about the current contracting season with payers for Humira and whether you think you'll be able to lock in multiyear contracts either now to extend it to 2023 or next year to extend to 2024.

Christopher Joseph Raymond: Thanks for taking the question. So on ABBV951 in Parkinson's, we're just hoping you could put some of the safety findings from the phase three trial in context, particularly the imbalance in hallucinations and psychosis and the 22%, I think, treatment discontinuation rate. Basically, just how did that safety profile stack up against your expectations? And how could this translate into real-world use of 951? Thanks.

Suppressor number a bullish with your guidance for the for the migraine franchise, given the strong trajectory of tomo ready any reason to think there's going to be a significant plateau in the years ahead. Thank you.

Yeah, Hi, it's Jeff so typically.

When we start to negotiate with the payers in the spring of the year for the following year.

Mike: So this is Mike. I'll take that question. With respect to the data for 951, we're very pleased with the data. There is very strong efficacy, and the safety is within our expectations. It matches our expectations across essentially all important areas.

And typically those contracts can be multi year contracts maybe.

Two year contracts, so really that's sort of the season, where we will have as Rob and Rick said, we will have probably some more guidance over how things are shaping up for 'twenty, three and possibly 24, depending on the posture of the payers and how those things work out. So we're we're not quite there yet.

Mike: What's important to keep in mind is this agent delivers transformative benefit to patients who have extremely difficult, and so the overall picture has to be looked at in that context. With respect to treatment discontinuations, what I would say is the treatment discontinuations rate overall is very similar to what you see with similar devices, with insulin pump-like devices used across a range of conditions. Most of these were driven by either local tolerability issues like injection site reactions, which were principally erythema, or technical usability issues because, you know, these are older patient populations with limited mobility and dexterity in many cases.

I think that what I can say is we're quite confident based on the timing that I described in terms of general cycles in terms of where we're going to be for our portfolio.

Certainly in 'twenty two.

In terms of <unk>.

Look we are off to a very good start I can I can I can tell you that <unk> continues to run at pace that total oral <unk> market is upwards of maybe 18% of new prescriptions and it's still early in that that would be us and <unk> in the acute segment and at a theoretical peak level you can.

Mike: And, you know, there's always a subset of patients who find that they have difficulty using any device under those circumstances. But again, those rates of discontinuation are very similar to what you see with similar insulin pump-like devices. And keep in mind, this is a very, very large population, this advanced Parkinson's population, only a very small proportion of which currently get advanced treatments because it's so limited in how they can be delivered. We think there's a big opportunity here.

See maybe 30 or 40% based on cardiovascular issues with triptans or some other issue. So we still have clear clearly some runway to go.

It's probably a little early to sort of determine how that preventative segment will really grow because you've only seen really the maps. So far they certainly tripled the market size, how will both of these oracle's and particularly in oral like you lift in terms of the market development run a pace.

Mike: And that treatment discontinuation rate doesn't change that and is in line with our expectation. With respect to hallucinations, we know that that is on mechanism. [inaudible] you know, to our eye, shows a lower degree of control, which matches the clinical efficacy data because we know falls are common in Parkinson's disease patients. So we need to keep that in mind. And with the efficacy that we've delivered, we think these are all, you know, [inaudible] Gastric tube, it's actually threaded into the small bowel to get deep brain stimulation and other types of measures. So this is a much less invasive approach that delivers very strong efficacy, and we think that will translate very, very effectively into the real world.

It's encouraging for sure, particularly if you have all three of these.

Three of these agents in the market and the investment behind it right now, though we feel quite comfortable with the with the $1 billion opportunity for both of the oral <unk>.

Thanks, Josh and that concludes today's conference call. If you would like to listen to a replay of the call. Please visit our website at investors not abbvie dot com. Thanks again for joining us.

This does conclude today's conference call. We thank you all for participating you may now disconnect and have a great rest of your day.

Ali: Thanks, Ali. Operator, we have time for one more.

Operator: Is it time for one final question?

Operator: That will come from Josh Schumer with Evercore ISI. Your line is open, sir.

Josh Schumer: Alright, thanks for squeezing me in. Can you talk about the current contracting season with payers for Humira and whether you think you'll be able to lock in multi-year contracts either now to extend to 2023 or next year to extend to 2024? And then I'm surprised you're not more bullish with your guidance for the migraine franchise given the strong trajectory it's on already. Any reason to think there's going to be a significant plateau in the years ahead? Thank you. Yeah, hi, it's it's Jeff.

Jeff: So typically, you know, when we start to negotiate with the payers in the spring of the year for the following year, and typically, those contracts can be multi-year contracts, maybe, you know, two-year contracts. So really, that's sort of the season where, as Rob and Rick said, we'll probably have some more guidance over how things are shaping up for 23, and possibly 24, depending on the posture of the payers and how those things work out. So we're not quite there yet.

[music].

Jeff: You know, I think that what I can say is we're quite confident based on the timing that I described in terms of general cycles, in terms of where we're going to be for our portfolio, certainly in 22. In terms of QLIPDA, look, we are off to a very good start; I can, I can, I can tell you that Ubrelvi continues to run apace, and the total oral CGRP market is upwards of maybe 18% of new prescriptions, and it's still early.

Jeff: And that that would be us and NURTEC in the acute segment. And at a theoretical peak level, you could see, you know, maybe 30 or 40%, based on cardiovascular issues with tryptams or some other issues. So we still have clear, clearly some runway to go.

Jeff: It's probably a little early to sort of determine how that preventative segment will really grow because you've only seen the MABs so far; they certainly tripled the market size. You know, how will both of these orals and, particularly, an oral like QLIPDA fare in terms of market development? It's, it's encouraging, for sure, particularly if you have all three of these agents in the market and the investment behind them. Right now, though, we feel quite comfortable with the billion-dollar opportunity for both of the orals.

Josh: Thanks, Josh. And that concludes today's conference call. If you would like to listen to a replay of the call, please visit our website at investors.abbvie.com. Thanks again for joining us.

Operator: So that does conclude today's conference call. We thank you all for participating. You may now disconnect and have a great rest of your day. ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? , , , , , , , , , , , , , , , , ??? ??? ??? ??? ??? ??? ??? Thank you for standing by.

Operator: Welcome to the AbbVie third quarter 2021 earnings conference call. All participants will be on a listen only until the question and answer portion of the call. You may ask a question by pressing star 1 on your phone. I would now like to introduce Ms. Liz Shea, Vice President of Investor Relations. May I please, 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 Stewart, Executive Vice President, Commercial Operations.

Operator: Before we get started, 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 statement. Additional information about these risks and uncertainties is included in our SEC file. We undertake no obligation to update these forward-looking statements except as required by law.

Operator: 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. Unless otherwise noted, our commentary on sales growth is on a comparable basis, which includes full current year and historical results for allergies. For this comparison of underlying performance, all historically reported Allergan revenues have been recast to conform to AbbVie's revenue recognition accounting policies and exclude the divestitures of ZENPEP and Biocase. References to operational growth further exclude the impact of the following. Following our prepared remarks, we'll take your questions.

Liz Shea: So with that, I'll now turn the call over to you. Thank you, Liz. Good morning, everyone. And thank you for joining us today. I'll discuss our third quarter performance and outlook, and then Geoff, Mike, and Rob will review our business highlights, pipeline progress, and financial results in more detail. AbbVie continues to perform very well. We once again delivered an outstanding quarter with adjusted earnings per share of $3.33, exceeding the midpoint of our guidance by $0.13. Total adjusted net revenues of more than $14.3 billion were up 10.8% on an operational basis, with balanced growth across each of the major growth platforms.

Rick Gonzalez: We continue to see double-digit revenue growth in immunology, where Skyrizzy and Renvoke have established very strong launch trajectories. These two assets are either approved under regulatory review or in late-stage development across all of Humira's major indications, and we remain confident that they will both be significant contributors to AbbVie's long-term growth. Aesthetics is also demonstrating impressive double-digit operational sales growth

[music].

Rick Gonzalez: , , , , , , , , Our dedicated global aesthetic structure and increased investment are driving accelerated category growth across both toxins and fillers, where there is substantial room for additional market penetration. Our strategic investments and targeted field force expansions have improved overall customer retention rates and significantly increased the number of first-time patients to our leading brand. We are once again raising our full year guidance for aesthetics this quarter, and we view this portfolio as an extremely attractive growth opportunity over the long term, with high single-digit compounded annual growth rates expected through the end of the decade.

Rick Gonzalez: Our neuroscience business drove robust double-digit revenue performance again this quarter, and we added a compelling new product to our migraine portfolio with the approval of Qlipta, a once-daily oral medication for the preventative treatment of episodic migraines. Our hematological oncology portfolio delivered operational sales growth of approximately 8% this quarter, despite a protracted market recovery in CLL, which remains below pre-COVID levels. Beyond the significant contributions of Imbruvica and Venclexta, we have an exciting oncology pipeline with several promising programs in development for blood cancers and solid tumors to support sustainable long-term growth. These include Nabitoclax for myelofibrosis, and Epicritimab for B-cell malignancy. 383 for multiple myeloma, Limsoparlimab for AML and MDS, as well as Talisov for non-squamous, non-small cell lung cancer.

Rick Gonzalez: Lastly, we continue to make excellent progress with the integration of Allergan. Our financial results show that we have created a stronger and much more diverse company, with numerous products across our newly combined portfolio, delivering robust growth. Overall, I'm extremely pleased with our momentum, and we are once again raising our full year 2021 EPS guidance. We now expect adjusted earnings per share of $12.63 to $12.67, reflecting growth of nearly 20% at the midpoint.

Thank you for standing by welcome to the Abbvie third quarter 2021 earnings conference call all participants.

The fence will be on a listen only until the question and answer portion of the call you.

You May ask a question by pressing star one on your phone.

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

Ma'am you May proceed.

Good morning, and thanks for joining US also on the call with me today are Rick and solid 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 before we get started some statements we make today may be <unk>.

Rick Gonzalez: Additionally, as noted in our news release, today we're announcing an eight and a half percent increase in our quarterly cash dividend from $1.30 per share to $1.41 per share, beginning with the dividend payable in February 2022. Since our inception, we've grown our quarterly dividend by more than 250%. In summary, we're demonstrating strong execution across our portfolio. We've assembled an impressive set of diversified assets with significant growth potential, giving us a high degree of confidence in the long-term outlook for our business. With that, I'll turn the call over to Jeff.

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 additional 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.

Jeffrey Ryan Stewart: Thank you, Rick. We continue to demonstrate strong and balanced growth across our therapeutic portfolio. I'll start with immunology, where we remain well-positioned for sustained leadership with a portfolio of best-in-class medicine. Total immunology revenues were approximately $6.7 billion, up 14.9% on an operational basis. Global Humira sales were more than $5.4 billion, up 5.2% on an operational basis. With 10.1% revenue growth in the U.S., offset by biosimilar competition across the international markets, where revenues were down 16.7% on an operational basis. Guy Rizzi is performing extremely well.

Conference call non-GAAP financial measures will be used to help investors understand abbey'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 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 is revenue recognition accounting policies and exclude the divestitures of <unk> and bio cases references to operational growth further exclude the impact of exchange.

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

Jeffrey Ryan Stewart: Global sales of nearly $800 million were up 18.1% on a sequential basis, reflecting Continued Market Share Gains. In the U.S., Skyrizzy's leading in-play psoriasis patient share, which includes both new and switching patients, is now roughly 36 percent, more than double the share captured by the next nearest biologic competitor. Sky Rizzi's Total Prescription Share in the U.S. psoriasis biologic market is now nearly 20%, second only to Humira. Internationally, Skyrizzy continues to ramp nicely, having also achieved in-play patient share leadership in more than a dozen key markets.

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

Abbvie continues to perform very well, we once again delivered an outstanding quarter with adjusted earnings per share of $3 33.

Exceeding the midpoint of our guidance by <unk> 13 cents.

Total adjusted net revenues of more than $14 3 billion.

Jeffrey Ryan Stewart: This compelling share performance will be further supported by two important near-term enhancements, the availability of more simple delivery forms for SCIRIS-E, as well as the potential indication expansion in psoriatic arthritis. First, we recently launched the new and convenient Skyrizzy single-dose, 150-milligram self-injectable pen and syringe in major territories around the world.

It was up 10, 8% on an operational basis with balanced growth across each of the major growth platforms.

Yes.

We continue to see double digit revenue growth in immunology, where sky Ritchie and Randgold have established very strong launch trajectories. These.

These two assets are either approved under regulatory review or in late stage development across all of Humira as major indications and we remain confident that they will both be significant contributors to add these long term growth.

Jeffrey Ryan Stewart: The market response has been very favorable, and the approval now makes Skyrizzy the only quarterly dose brand that is available in a single self-injectable pen for patients. Additionally, we are preparing for the global launch of Skyrizzy in psoriatic arthritis as we near approval decisions in both the U.S. and Europe. We received a CHMP positive opinion earlier this month with anticipated approval in Europe by year-end, and we continue to expect FDA approval early next year.

Our strategy is also demonstrating impressive double digit operational sales growth.

Our dedicated global aesthetic structure and increased investment are driving accelerated category growth across both toxins and pillars, where there is substantial room for additional market penetration.

Our strategic investments and targeted field force expansions have improved overall customer retention rates and significantly increased the number of first time patients to our leading brands.

Jeffrey Ryan Stewart: The addition of this indication, once approved, will round out Skyrizzy's dermatology label and give patients with PSA access to a new, compelling therapeutic option. We are also making excellent progress with Skyriz's development in Crohn's disease, which was recently submitted for U.S. regulatory review with commercialization expected next. Renvoke also continues to demonstrate robust growth. Global sales of more than $450 million were up nearly 20% on a sequential basis.

We are once again, raising our full year guidance for steady this quarter and we view. This portfolio is an extremely attractive growth opportunity over the long term with high single digit compounded annual growth rates expected through the end of the decade.

Our neuroscience business drove robust double digit revenue performance again, this quarter and we added a compelling new product to our migraine portfolio with the approval of <unk> or.

Jeffrey Ryan Stewart: Total in-play RA share remains strong and now reflects approximately 17% patient share in the U.S., as well as leadership in a half-dozen key countries around the world. Internationally, Renvoke Share continues to ramp up in RA, and we are making excellent progress with the recent commercial launches of PSA, AS, and atopic dermatitis, where we have secured strong labels for each of these indications. As many of you are aware, the FDA issued a safety communication regarding new and updated warnings for JAK inhibitors, including RINVOC, in early September.

A once daily oral medication for the preventative treatment of episodic migraine.

Our hematological oncology portfolio delivered operational sales growth of approximately 8% this quarter, despite a protracted market recovery and C O L.

Which remains below pre COVID-19 levels.

Beyond the significant contributions of improve again, Ben collect stuff.

We have an exciting oncology pipeline with several promising programs in development for blood cancers, and solid tumors to support sustainable long term growth. These include Nevada Clacks for Myelofibrosis Epicritic Mad for B cell malignancies, ABVD 383 for multiple myeloma.

Jeffrey Ryan Stewart: While we do not yet have an updated label, we are closely monitoring prescription trends and feedback from the field, and we have not observed a significant impact on Renvo's utilization at this time. That said, should the updated label restrict use to TNF-inadequate responders, we would certainly expect a near-term impact on new patient starts in RA. Based on the robust data we have generated across our development program against multiple biologics and later lines of RA therapy, we do expect that RINVOC will ultimately obtain higher share growth in the second line plus setting, as most patients ultimately fail TNF therapies over. Overall, we continue to feel very good about the performance and profile of Renvoke and remain confident this asset will be a major contributor to AbbVie's long-term growth.

Lemzo Parliament for AML, and Mds as well as police Aviv for non squamous non small cell lung cancer.

Lastly.

We continue to make excellent progress with the integration of Allergan.

Financial results show that we have created a stronger and much more diverse company with numerous products across our newly combined portfolio delivering robust growth.

Overall I'm extremely pleased with our momentum and we are once again, raising our full year 2021, EPS guidance. We now expect adjusted earnings per share of $12 63 to.

To $12 67.

Reflecting growth of nearly 20% at the midpoint.

Additionally, as noted in our news release today, we are announcing an eight 5% increase in our quarterly cash dividend from $1 30 per share to $1 41 per share beginning with the dividend payable in February 2022.

Jeffrey Ryan Stewart: In hematologic oncology, global revenues were nearly $1.9 billion, up 8.1% on an operational basis. Ambruvica and Venklexta have a strong position across multiple HEIM indications, including CLL, where AbbVie's combined portfolio remains the clear market share leader across all lines of therapy. Global Imbruvica revenues were approximately $1.4 billion, up 0.3%.

Since our inception, we've grown our quarterly dividend by more than 250%.

In summary, we are demonstrating strong execution across our portfolio. We've assembled an impressive set of diversified assets with significant growth potential, giving us a high degree of confidence in the long term outlook for our business with that I'll turn the call over to Jeff Jeff. Thank you Rick.

Jeffrey Ryan Stewart: In the U.S., performance continues to be primarily impacted by a slower-than-expected market recovery in CLL, as well as some modest share erosion from newer therapies, including Venclexta and other BTK inhibitors. New patient starts in CLL remain below pre-COVID levels, and it is difficult to predict when this dynamic may fully recover. BenClexa sales were up 38.7% on an operational basis, with increasing momentum across all indications, including a strong AML launch trajectory in the international market.

And we continue to demonstrate strong and balanced growth across our therapeutic portfolio.

I'll start with immunology, where we remain well positioned for sustained leadership with a portfolio of best in class medicines total.

Total immunology revenues were approximately $6 $7 billion up 14, 9% on an operational basis.

Global Humira sales were more than $5 4 billion up five 2% on an operational basis with 10, 1% revenue growth in the U S offset by Biosimilar competition across the international markets, where revenues were down 16, 7% on an operational basis.

Jeffrey Ryan Stewart: In neuroscience, revenues were nearly $1.6 billion, up 25% on an operational basis. I'm particularly pleased with the results and outlook for our Emerging Migraine Portfolio, where we are now the only company to have a portfolio of distinctive therapies to address the spectrum of this common, complex, and debilitating disease, including... Botox Therapeutic, a unique foundational treatment for the prevention of chronic migraine, which is performing very well. Total sales of $645 million for all the therapeutic Botox uses were up 22.5% on an operational basis. Brelvie.

<unk> is performing extremely well.

Global sales of nearly $800 million were up 18, 1% on a sequential basis, reflecting continued market share gains.

In the U S Guy really sky <unk>, leading in play psoriasis patient share, which includes both new and switching patients is now roughly 36% more than double the share capture of the next nearest biologic competitor sky.

<unk> total prescription share in the U S. Psoriasis biologic market is now nearly 20% second only to Humira.

Internationally Sky Rajiv continues to ramp nicely, having also achieved in play patient share leadership in more than a dozen key markets.

Jeffrey Ryan Stewart: Our leading oral CGRP treatment for acute migraine is also demonstrating rapid growth. Total sales of $162 million were up nearly 30% on a sequential basis. Based on Ubrelvi's competitive profile, continued strong new patient starts, and a rapidly expanding market, we remain confident that Ubrelvi represents a $1 billion plus peak sales opportunity. And now we are just launching Qlipta, the only oral CGRP specifically developed for the preventative treatment of migraine, which is already off to an excellent start.

This compelling share performance will be further supported by two important near term enhancements the availability of more simple delivery forms for sky rizzi as well as the potential indication expansion in Psoriatic arthritis.

First we recently launched the new and convenient Sky Rizzi single dose 150 milligram self injectable pennant syringe and major territories around the world. The market response has been very favorable and the approval now makes <unk>. The only quarterly dose brand that is available in a single <unk>.

Jeffrey Ryan Stewart: Early feedback from our physicians has been very positive, giving Q-LIFT a strong efficacy, safety, and convenient dosing profile relative to the current standards. The Tulip to Launch is being supported by our existing migraine sales force, with commercial access expected to ramp strongly through the first half of 2022. Tulipta also represents a $1 billion plus peak sales opportunity.

Self injectable pen for patients.

Second we are preparing for the global launch of <unk> in Psoriatic arthritis, as we near approval decisions in both the U S and Europe.

We received a see HMP positive opinion earlier this month with anticipated approval in Europe by year end and we continue to expect FDA approval early next year.

The addition of this indication once approved will round out <unk> dermatology label and give patients with PSA access to a new compelling therapeutic option.

Jeffrey Ryan Stewart: Now we believe having three distinct and competitively positioned therapies across the spectrum of migraine conditions with Botox Therapeutic, Ubrella, and Q-Lypta, which each have been optimized for a specific migraine indication, enables physicians to tailor treatment for the broadest range of patients. Our portfolio of migraine therapy puts us in a very strong position to capture growth in this dynamic market. Turning to psychiatry, we also see robust performance with RALAR, which remains the fastest growing atypical antipsychotic. Total revenues of $461 million were up 29% on an operational basis, with continued strong demand across schizophrenia, bipolar 1 disorder, and bipolar depression.

We are also making excellent progress with <unk> development in Crohn's disease, which was recently submitted for U S regulatory review with commercialization expected next year.

RIN book also continues to demonstrate robust growth.

Sales of more than $450 million were up nearly 20% on a sequential basis total in play share remained strong and now reflects approximately 17% patient share in the U S as well as leadership and a half a dozen key countries around the world.

Internationally were invoked share continues to ramp in RA and we are making excellent progress with the recent commercial launches of PSA Aaas and atopic dermatitis, where we have secured strong labels for each of these indications.

As many of you are aware the FDA issued a safety communication regarding new and updated warnings for JAK inhibitors, including <unk> in early September.

Jeffrey Ryan Stewart: Lastly, in our other key therapeutic areas, we saw a significant contribution from eye care, which had revenues of $871 million, up 2.9% on an operational basis. Maverick sales were $426 million, up 2.9% on an operational basis, as treated patient volumes still remain suppressed compared to pre-COVID levels, and we saw double-digit growth operationally for both Creon and Lupron. So overall, I'm pleased with our continued execution across the therapeutic portfolio, which is demonstrating strong revenue growth. And with that, I'll turn the call over to Mike for additional comments on our R&D programs. Mike.

While we do not yet have an updated label we are closely monitoring prescription trends and feedback from the field and we have not observed a significant impact to <unk> utilization at this time.

That said should the updated label restrict use the TNF inadequate responders, we would certainly expect a near term impact to new patient starts NRA.

Based on the robust data we've generated across our development program against multiple biologics and later lines of therapy, we do expect that <unk> will ultimately obtain higher share growth in the second line plus setting as most patients ultimately fail TNF therapies over time.

Overall, we continue to feel very good about the performance and profile of Rainbow and remain confident this asset will be a major contributor to add these long term growth.

Michael Severino: Thank you, Geoff. I'll start with immunology, where we had several regulatory updates and data readouts for both the RINVOC and SkyRISI across therapeutic areas. Following the successful completion of the registrational programs for RINVOC in ulcerative colitis and SCIRISI in Crohn's disease, we submitted our regulatory applications for each asset in their respective indications. We saw very strong data for both RINVOC and SCIRISI as induction and maintenance treatments for UC and Crohn's, respectively.

In hematologic oncology global revenues were nearly $1 9 billion up eight 1% on an operational basis.

And <unk> that have a strong position across multiple heme indications, including CLO, where add these combined portfolio remains the clear market share leader across all lines of therapy.

Global <unk> revenues were approximately $1 4 billion up <unk>, 3% in the U S performance continues to be primarily impacted by a slower than expected market recovery in CLO as well as some modest share erosion from newer therapies, including <unk> and other <unk> inhibitors.

Michael Severino: Based on these results, we believe both drugs have the potential to become highly effective differentiated therapies in these indications. We anticipate approval decisions for both in 2022. Earlier this month, we announced positive top-line results from our Phase 3 Select Access 2 program for Renvoke and AxialSpot, which included data from two standalone studies, one for ankylosing spondylitis patients who had an inadequate response to biological therapy and another for patients with non-radiographic axial spas. In the ankylosing spondylitis biorefractory study, Rynbroke performed very well, demonstrating significantly greater improvement in signs and symptoms, as well as physical function and imaging endpoints compared to placebo.

Yeah.

New patient starts and CLO remain below pre COVID-19 levels and it is difficult to predict when this dynamic may fully recover.

<unk> sales were up 38, 7% on an operational basis with increasing momentum across all indications, including a strong AML launch trajectory and the international markets.

In neuroscience revenues were nearly $1 6 billion up 25% on an operational basis, I am, particularly pleased with the results and outlook for our emerging migraine portfolio, where we are now the only company to have a portfolio of distinctive therapies to address the spectrum of this common complex in <unk>.

<unk> disease include.

Including Botox therapeutic a unique foundational treatment for the prevention of chronic migraine, which is performing very well total sales of $645 million for all of the therapeutic botox users were up 22, 5% on an operational basis.

Michael Severino: We saw levels of efficacy in this difficult-to-treat refractory population, similar to those more typically observed in bio-naive patients. These results will be added to our submission package for RINVOC and AS, which is currently under review by the FDA. In the non-radiographic axial spot study, Rynvelk also performed very well, meeting the primary and key secondary endpoints. We plan to submit our regulatory applications in this indication later this quarter as well. Rynvoke's safety profile in these axial spa trials was consistent with previous studies, and there was no evidence of increased risk of DVT, PE, MACE events, or malignancies in either study.

<unk>, our leading oral <unk> treatment for acute migraine is also demonstrating rapid growth total sales of $162 million were up nearly 30% on a sequential basis.

<unk> competitive profile continued strong new patient starts and a rapidly expanding market. We remain confident that <unk> represents a $1 billion plus peak sales opportunity.

And now we are just launching to lift up the only oral <unk> specifically developed for the preventative treatment of migraine, which is already off to an excellent start.

Michael Severino: Based on the data generated in the Select AXIS program, we believe Renvogue has the potential to improve care for patients suffering from axial spondyloarthritis by providing sustained disease control and rapid and durable pain reduction, as well as improving function. As you're likely aware, in September, the FDA communicated that it would require new warnings for JAK inhibitors, including RINVOC, and their use will be limited to certain patients who have not responded to or cannot tolerate anti-TNF.

Early feedback from our physicians has been very positive given <unk> lift is strong efficacy safety and convenient dosing profile relative to the current standards of care.

For Q lift the launch is being supported by our existing migraine salesforce with commercial access expected to ramp strongly through the first half of 2022.

To lift to also represents a $1 billion plus peak sales opportunity.

Now, we believe having three distinct and competitively positioned therapies across the spectrum of migraine conditions with botox therapeutic <unk>, which each have been optimized for a specific migraine indication enable physicians to tailor treatment for the broadest range of patients our portfolio of migraine therapy puts us in a.

Michael Severino: We continue to work with the FDA regarding updated labeling language for the RA indication while simultaneously engaging with the agency on our files for atopic dermatitis, psoriatic arthritis, and ankylosing spondylitis. We remain confident in our submission packages for these three new indications and continue to expect approvals following completion of the RA label update. In the area of oncology, we continue to make good progress advancing all stages of our pipeline. We're nearing completion of several indication expansion programs, such as our study in previously untreated higher-risk MDS patients, which recently received a breakthrough therapy designation. We expect to make a data cut early next year to include six-month follow-up data for duration of response.

A very strong position to capture growth in this dynamic market.

Turning to psychiatry, we also see robust performance with <unk>, which remains the fastest growing atypical anti psychotic total revenues of $461 million were up 29% on an operational basis with continued strong demand across schizophrenia bipolar one disorder.

<unk> in bipolar depression.

Lastly in our other key therapeutic areas, we saw a significant contribution from eyecare, which had revenues of $871 million up two 9% on an operational basis.

Michael Severino: Based on this data cut, we plan to submit our regulatory application to the FDA in the first half of 2022 for an accelerated approval. We continue to make good progress with BenClexta in the CANOVA trial, which is evaluating BenClexta in relapsed refractory multiple myeloma patients with a T11-14 mutation. VanClexta has shown strong anti-myeloma activity in this biomarker-defined population and, if successful, has an opportunity to play an important role in the treatment paradigm for multiple myeloma.

Maverick sales were $426 million up two 9% on an operational basis as treated patient volumes still remain suppressed compared to pre COVID-19 levels.

And we saw double digit growth.

Operationally, both creon and Lupron.

So overall I'm pleased with our continued execution across the therapeutic portfolio, which is demonstrating strong revenue growth and with that I'll turn the call over to Mike for additional comments on our R&D programs, Mike. Thank you Jeff.

Michael Severino: We expect a data readout from this event-driven trial next year, in our early to mid-stage HEMON pipeline. We continue to expand the cohorts in the EPCRIT and MAB Phase 1-2 studies in diffuse large B-cell lymphoma and follicular lymphoma, and we're evaluating F-carinumab as both monotherapy and in combination.

I'll start with immunology.

Where we had several regulatory updates and data readouts for both the <unk> and sky rizzi across therapeutic areas.

Following successful completion of the Registrational programs for <unk> in ulcerative colitis, and Sky <unk> in Crohn's disease, we submitted our regulatory applications for each asset in their respective indications.

Michael Severino: We expect to see data from both the monotherapy and combo studies next year, and we will discuss the monotherapy data with regulators regarding a file for accelerated approval. We have also recently begun the dose escalation stage of the Phase 1B studies for Lems of Parlimen in AML, MDS, and multiple myeloma, and ABBV383, our BCMA CD3 bispecific antibody, is currently in the expansion stage of And we expect to begin registrational phase three studies next year. Moving to neuroscience, where we have had several notable pipeline events since our last earnings call. In September, we received FDA approval for QLIPDA, the only oral CGRP specifically designed as a preventative treatment for migraines.

We saw very strong data for both the <unk> and sky rosy as induction and maintenance treatments in UC and Crohn's respectively.

And based on these results we believe both drugs have the potential to become a highly effective differentiated therapies in these indications.

We anticipate approval decisions for both in 2022.

Earlier this month, we announced positive topline results from our phase III select access to program for invoke an axial spa.

Which included data from two Standalone studies.

One for ankylosing spondylitis patients, who had an inadequate response to biologics and another for patients with non radiographic axial spa.

Michael Severino: We're very pleased with the label, which reflects QLiPT's strong benefit-risk profile and is supported by a robust clinical development program. And our registrational program, which evaluated Q-Lypta in nearly 2,000 patients suffering from episodic migraine, showed that treatment with Q-Lypta resulted in a significant reduction in mean monthly migraine days compared to placebo.

And the ankylosing spondylitis bio refractory study RIN broke performed very well demonstrating significantly greater improvements in signs and symptoms as well as physical function and imaging endpoints compared to placebo.

We saw levels of efficacy in this difficult to treat refractory population similar to those more typically observed in bio naive patients.

These results will be added to our submission package for Rainbow can Aaas, which is currently under review by the FDA.

Michael Severino: And approximately 60% of patients achieved at least a 50% reduction in mean migraine days. We think these data compare favorably to other preventative migraine treatments on the market and believe our new oral treatment option will be competitively positioned in the prevention market. Our migraine portfolio now includes Ubrelvi for the acute treatment of migraine, Q-Lypta for the preventative treatment of episodic migraine, and Botox for the preventative treatment of chronic migraine.

And the non radiographic axial Spa study <unk> also performed very well meeting the primary and key secondary endpoints.

We plan to submit our regulatory applications in this indication later this quarter as well.

<unk> safety profile in these axial spa trials was consistent with previous studies and there was no evidence for increased risk of DVT PE mace events or malignancies in either study.

Based on the data generated in the select access program. We believe <unk> has the potential to improve care for patients suffering from axial spondylarthritis by providing sustained disease control and rapid and durable pain reduction as well as improving function.

Michael Severino: With this distinct portfolio, AbbVie is uniquely positioned to address the full spectrum of this complex and debilitating disease. This morning, we announced top-line results from two Phase 3 studies evaluating Braylor as an adjunctive treatment for major depressive disorders. In the 301 study, the 1.5 milligram Braylor dose met the primary endpoint, demonstrating a clinically meaningful improvement in total MATRA score compared to placebo at week six with a highly statistically significant p-value of 0.005. In this study, the 3 mg Braylar dose did not reach statistical significance.

As youre likely aware in September the <unk>.

<unk> communicated that they will require new warnings for JAK inhibitors, including <unk> Belk and their use will be limited to certain patients who have not responded to or cannot tolerate anti TNF.

We continue to work with the FDA regarding updated labeling language for the <unk> indication.

While simultaneously engaging with the agency on our files for atopic dermatitis, Psoriatic arthritis, and ankylosing spondylitis.

Michael Severino: But it did show a clear trend toward improvement with a nominal p-value of approximately 0.073 at week six. In the second phase 3 trial, the 302 study, neither Braylor dose met the primary endpoint of change in total Madras score at week 6, but both the 1.5 and 3 milligram doses demonstrated clear trends toward a clinically meaningful benefit at weeks 2 and 4, with nominal p-values less than 0.05 for a number of comparisons.

We remain confident in our submission packages for these three new indications and continue to expect approvals following completion of the <unk> label update.

In the area of oncology, we continue to make good progress advancing all stages of our pipeline.

We're nearing completion of several indication expansion programs for <unk>.

In our study in previously untreated higher risk Mds patients, which recently received a breakthrough therapy designation we.

Michael Severino: Additionally, as a reminder, we have one prior positive registration of a phase 2B study where Raylard demonstrated efficacy in MDD when added to ongoing antidepressants. Based on precedent in the field and the totality of the data, we believe we have a viable regulatory pathway for Graylar as an adjunctive treatment for major depressive disorders.

We expect to make a datacom early next year to include six month follow up data for duration of response.

Based on this data cut we plan to submit our regulatory application to the FDA in the first half of 2022 for an accelerated approval.

We continue to make good progress with <unk> in the Canova trial, which is evaluating <unk> in relapsed refractory multiple myeloma patients with a T 11 14 mutation.

Michael Severino: We plan to engage with regulatory agencies to discuss these results and expect to submit our regulatory application to the FDA in the first half of next year. We also recently announced positive top-line results from a Phase 3 study comparing our novel subcutaneous levodopa-carbidopa delivery system, ABBB951, to oral levodopa-carbidopa in patients with advanced Parkinson's, In this pivotal study, treatment with 9-5-1 resulted in clinically meaningful improvement in on-time, without troublesome dyskinesia, as well as similar improvement in normalized off-time compared to oral levodopa carbidopa.

<unk> has shown strong anti myeloma activity in this biomarker defined population and if successful has an opportunity to play an important role in the treatment paradigm for multiple myeloma.

We expect the data readout from this event driven trial next year.

And our early to mid stage him on pipeline.

We continue to expand the cohorts in the <unk> phase <unk> studies in diffuse large b cell lymphoma, and Follicular lymphoma, and we are evaluating <unk> as both a monotherapy and in combinations.

Michael Severino: We're very pleased with these results, which we believe support our view that 951 has the potential to become a transformative improvement to current treatment options for patients with advanced Parkinson's. We plan to submit our regulatory application next year, with approval decisions anticipated in the U.S. and Europe in early 2023. And at iCare, we announced a partnership with Regenexx Bio to develop and commercialize RGX 314. Potential gene therapy for the treatment of wet AMD, diabetic retinopathy, and other chronic retinal diseases

We expect to see data from both the monotherapy and combo studies next year, and we will discuss the monotherapy data with regulators regarding a file for accelerated approval.

We also recently began the dose escalation stage of the phase <unk> studies for lemons of Parliament in AML, Mds and multiple myeloma.

And a BBB <unk> III or <unk> bi specific antibody is currently in the expansion stage of its phase one study in multiple myeloma patients and we expect to begin Registrational phase III studies next year.

Michael Severino: RGX 314 is a very attractive addition to our pipeline and complements our eye care portfolio with a potential flagship product in retinal disease. Regenexx Bio recently presented initial data from two Phase II studies evaluating RGX314 in wet AMD and diabetic retinopathy using in-office supracaroidal delivery. While early, these results are encouraging, with RGX 314 demonstrating efficacy at the lowest dose, and studies showing that the drug and delivery method both appear to be well-tolerated.

Moving to neuroscience, where we had several notable pipeline events since our last earnings call.

In September we received FDA approval for <unk>.

The only oral <unk>, specifically designed as a preventative treatment for migraine.

We're very pleased with the label, which reflects <unk> strong benefit risk profile and is supported by a robust clinical development program.

And our Registrational program, which evaluated <unk> in nearly 2000 patients suffering from episodic migraine treatment with <unk> resulted in a significant reduction in mean monthly migraine days compared to placebo in approximately 60% of patients achieved at least a 50% reduction in <unk>.

Michael Severino: Also in ICARE, we continue to expect approval for VUITY, formerly known as AGN 190584, for the treatment of symptoms associated with presbyopia. This once-daily eyedrop was developed to help address the presbyopia that is often corrected through reading glasses and, once approved, would be a convenient, on-demand solution for patients with mild to moderate presbyopia who may not want to wear reading glasses.

<unk> days.

We think these data compare favorably to other preventative migraine treatments on the market and believe our new oral treatment option will be competitively positioned in the prevention market.

Our migraine portfolio now includes <unk> for acute treatment of migraine Q lifter for preventative treatment of episodic migraine and botox for preventative treatment of chronic migraine.

Michael Severino: This has been a very productive year thus far for our R&D organization, and we anticipate several additional milestones in the coming months. We expect this momentum to continue into next year, which is looking to be a milestone-filled year for AbbVie as well. With that, I'll turn the call over to Rob for additional comments on our third quarter performance and financial outlook.

With this distinct portfolio Abbvie is uniquely positioned to address the full spectrum of this complex and debilitating disease.

This morning, we announced topline results from two phase III studies evaluating <unk> as an adjunctive treatment in major depressive disorder.

Robert A. Michael: Thank you, Mike. As you have heard from Rick, Geoff, and Mike, we once again delivered outstanding performance this quarter while also advancing our strategic priorities. Our results demonstrate the strong momentum of the business and support AbbVie's long-term financial outlook. Turning to third-quarter results, we reported adjusted earnings per share of $3.33, up 17.7% compared to the prior year and $0.13 above our guidance midpoint. This includes $0.05 from accelerated synergies and $0.03 from mark-to-market equity gains.

In the 301 study the one five milligram bid for a large dose met the primary endpoint demonstrating a clinically meaningful improvement in total noninterest score.

Impaired to placebo at week, six with a highly statistically significant P value of 0.005.

In this study the three milligram <unk> dose did not reach statistical significance, but it did show a clear trend toward improvement with a nominal P value of approximately 0.073 at week six.

In the second phase III trial, the 302 study neither alar dose met the primary endpoint of change in total noninterest score at week six but both the one five and three milligram doses demonstrated clear trends toward a clinically meaningful benefit in weeks, two and four with nominal P.

Robert A. Michael: Total adjusted net revenues were $14.3 billion, up 10.8% on an operational basis, excluding a 0.5% favorable impact from foreign exchange. The adjusted operating margin ratio was 51.1% of sales, an improvement of 230 basis points versus the prior year. This includes an adjusted gross margin of 83.2% of sales, adjusted R&D investment of 11.4% of sales, and adjusted SG&A expense of 20.6% of sales. Net interest expense was $585 million, and the adjusted tax rate was 12.6%.

Values less standpoint zero five for N number of comparisons.

<unk> as a reminder, we had one prior positive Registrational phase <unk> study, where <unk> demonstrated efficacy in <unk> when added to ongoing antidepressant trains.

Based on precedent in the field and the totality of the data. We believe we have a viable regulatory pathway for <unk> as an adjunct treatment in major depressive disorder.

We plan to engage with regulatory agencies to discuss these results and expect to submit our regulatory application to the FDA in the first half of next year.

We also recently announced positive top line results from a phase III study comparing our novel subcutaneous Levodopa Carbo Dopa delivery system, ABB 90, 512, oral levodopa carbo dopa in patients with advanced Parkinson's disease.

Robert A. Michael: As Rick previously mentioned, we are raising our fully-adjusted earnings per share guidance to between $12.63 and $12.67, reflecting growth of 19.8% at the midpoint. Excluded from this guidance is $6.34 of known intangible amortization and specified items.

In this pivotal study treatment with 95, one resulted in clinically meaningful improvement in on time without troublesome dyskinesia as well as similar improvement in normalized off time compared to oral levodopa carboplatin.

Robert A. Michael: This guidance continues to contemplate full-year revenue growth of 10.7% on a comparable operational basis. At current rates, we now expect foreign exchange to have a 0.7% favorable impact on full-year comparable sales growth. This implies a full-year revenue forecast of approximately $56.2 billion. Also included in this guidance are the following updated FOIA assumptions.

We're very pleased with these results, which we believe supports our view that 95, one has the potential to become a transformative improvement to current treatment options for patients with advanced Parkinson's disease.

We plan to submit our regulatory application next year with approval decisions anticipated in the U S and Europe in early 2023.

Yes.

And in Eyecare.

We announced a partnership with <unk> to develop and commercialize our gx $3 14, a potential gene therapy for the treatment of wet AMD diabetic retinopathy and other chronic retinal diseases.

Robert A. Michael: We now expect aesthetics global revenue of approximately $5.1 billion. We now expect international humerus sales of approximately $3.3 billion. For Imbruvica, we now expect global revenue of approximately $5.5 billion, reflecting a slower recovery of the CLL market. For Maverette, we now expect global sales of approximately $1.7 billion, and we now expect Allergan expense synergies of approximately $1.8 billion. As we look ahead to the fourth quarter, we anticipate net revenue approaching $15 billion. At current rates, we expect foreign exchange to have a modest, unfavorable impact on sales growth.

<unk> hundred 14 is a very attractive addition to our pipeline and complements our eye care portfolio with a potential flagship product and retinal disease.

<unk> bio recently presented initial data from two phase II studies evaluating <unk> 314 in wet AMD and diabetic retinopathy using in office Super Choroidal delivering.

While early these results are encouraging with <unk> 314, demonstrating efficacy at the lowest dose and the study is showing that the drug and delivery method, both appear to be well tolerated.

Robert A. Michael: We expect adjusted earnings per share between $3.24 and $3.28, excluding approximately $1.14 of known intangible amortization and specified items. Finally, AbbVie's strong business performance continues to support our capital allocation priorities. We generated $17 billion of free cash flow in the first nine months of the year, and our cash balance at the end of September was $12 billion.

Also in eye care, we continue to expect approval for beauty shortly formerly known as AGN 190584 for the treatment of symptoms associated with presbyopia.

This once daily eye drop was developed to help address the presbyopia that is often corrected through reading glasses and once approved would be a convenient on demand solution for patients with mild to moderate presbyopia, who may not want to wear reading glasses.

Robert A. Michael: Underscoring our confidence in AbbVie's long-term outlook, today we announce an 8.5% increase in our quarterly cash dividend, beginning with the dividend payable in February 2022, and we remain on track to achieve $17 billion of cumulative debt paydown by the end of this year, with further deleveraging through 2023. This will bring our net leverage ratio to 2.3 times by the end of 2021 and approximately two times by the end of 2022. In closing, AbbVie has once again delivered outstanding results, and our financial outlook remains very strong.

This has been a very productive year, thus far for our R&D organization and we anticipate several additional milestones in the coming months.

We expect this momentum to continue into next year, which is looking to be a milestone filled year for abbvie as well.

With that I'll turn the call over to Rob for additional comments on our third quarter performance and financial outlook, Rob. Thank you Mike as you have heard from Rick Jeff and Mike. We once again delivered outstanding performance. This quarter, while also advancing our strategic priorities our results demonstrate the strong momentum in the business and support Abbvie is long.

Robert A. Michael: With that, I'll turn the call back over to Liz. Thanks, Rob. We will now open the call to 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. Operators will take the first question.

Term financial outlook.

Turning to third quarter results, we reported adjusted earnings per share of $3 33.

Up 17, 7% compared to prior year and 13 above our guidance midpoint. This includes <unk> centrum accelerated synergies and three central Mark to market equity gains.

Liz Shea: Thank you, Ms. Shea. Our first question comes from Jeffrey Porges on behalf of Leroy.

Jeffrey Porges: Jeffrey Porges, with Lee Ring, your line is open. Thank you very much.

Total adjusted net revenues were $14 3 billion up.

Rick Gonzalez: Rick, I guess I'll jump in with the big one that I think is still the overhang for the stock, which is the RINVOC Outlook. You have $15 billion out there for 2025 in combined SCARISI RINVOC forecast guidance. And I'm just wondering if you could give us a sense of the puts and takes. SCARISI is doing really well, but there are some overhangs for RINVOC. Is that $15 billion still achievable? Do you think you're trending above that? Or do you have to make up the shortfall? Thanks. Yeah, I mean, Jeffrey, this is Rick.

Up 10, 8% on operational basis, excluding a 0.5% favorable impact from foreign exchange.

The adjusted operating margin ratio was 51, 1% of sales an improvement of 230 basis points versus the prior year. This includes adjusted gross margin of 83, 2% of sales adjusted R&D investment of 11, 4% of sales and adjusted SG&A expense up 26% of <unk>.

Sales net interest expense was $585 million and the adjusted tax rate was 12, 6%.

Rick Gonzalez: It's a great question. What I'd say is the following. If I look at Sky Rizzi, I would tell you that Sky Rizzi's performance is very, very impressive. You know, Geoff outlined what the in-play share is and what the total TRXs are, and it's very close to passing the marina, which in this short period of time, it's frankly a surprise how quickly it has rammed. So I think that's a very positive case. If I look at RENVO, the implant share actually looks very good.

As Rick previously mentioned, we are raising our full year adjusted earnings per share guidance to between $12 63.

And $12 67.

Reflecting growth of 19, 8% at the midpoint.

Excluded from this guidance is $6 34.

Known intangible amortization and specified items.

This guidance continues to contemplate full year revenue growth of 10, 7% on a comparable operational basis at current rates. We now expect foreign exchange had a 0.7% favorable impact on full year comparable sales growth. This implies a full year revenue forecast of approximately $56 2 billion.

Rick Gonzalez: Now, we would expect if the label gets changed and restricts the label to behind TNFs, that that will have some impact on the frontline patients, the naive patients that we're capturing now. And so we will see that impact. Having said that, I would say that when I look at RENVO's performance overall and how durable it has been throughout this situation, it will obviously shift more towards second-line patients and beyond, which was originally in the plan, but the emphasis would have occurred a year or two later than this, where we would have driven that.

<unk>.

Included in this guidance are the following updated full year assumptions, we now expect aesthetics global revenue of approximately $5 $1 billion. We now expect international Humira sales of approximately $3 3 billion from.

For <unk>, we now expect global revenue of approximately $5 $5 billion, reflecting slower recovery of the CLO market.

For Maverick, we now expect global sales of approximately $1 7 billion.

And we now expect Allergan expense synergies of approximately $1 8 billion.

Rick Gonzalez: We have very good data to be able to support that. The other thing I'd say is, if you look at the indications that we have coming out for these two assets, we have AD, which is a very significant opportunity for us. We have PSA, and it's a very significant opportunity. But next year we have the IBD indications that are coming out.

As we look ahead to the fourth quarter, we anticipate net revenue approaching $15 billion at current rates, we expect foreign exchange had a modest unfavorable impact on sales growth.

We expect adjusted earnings per share between $3 24.

And $3 28.

Excluding approximately $1 14.

Rick Gonzalez: And I'd say there, when we gave the $15 million forecast, the performance that was in our QPP or our target product profile, that we had assumed, we have outperformed that in the clinical trials that we've submitted. And so I think that's a very significant opportunity for us and a significant opportunity for us to outperform. Having said all of that, we don't want to reconfirm the guidance yet.

Of known intangible amortization and specified items.

Finally, abbvie strong business performance continues to support our capital allocation priorities, we generated $17 billion of free cash flow in the first nine months of the year and our cash balance at the end of September was $12 billion.

Underscoring our confidence in <unk> long term outlook today, we announced an eight 5% increase in our quarterly cash dividend beginning with the dividend payable in February 2022, and we remain on track to achieve $17 billion of cumulative debt paydown by the end of this year with further deleveraging through 2023.

Rick Gonzalez: We want to see what the final label looks like from the agency. And then we'll be in a position, I think, to come out and tell the investor community exactly what. The only other thing I'd say is... You know, I think if you go back five, six years ago, what we were trying to accomplish with the company, we were basically trying to accomplish with the company, build a set of assets that could ultimately significantly replace Humira in the marketplace and be superior to Humira.

Bring our net leverage ratio to two three times by the end of 2021 and approximately two times by the end of 2022.

In closing Abbvie has once again delivered outstanding results and our financial outlook remains very strong with that I'll turn the call back over to Liz.

Rick Gonzalez: These two assets are already at $5 billion and growing very rapidly, so I think everything I know about these two assets, they'll be able to do exactly what we expected. Even in the most negative outcome from a label, which we would expect. The second thing is we built a significant... Heemant Portfolio, that when I look at the pipeline behind Imbruvica and Ben Klecht, I think there's a significant opportunity, [inaudible] And I think we're performing at an outstanding level. I think migraine is a very significant opportunity for us to be able to drive. And I care is another one.

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 operator, we'll take the first question.

Thank you Michelle on your first question comes from Geoffrey Porges with Leerink. Your line is open Sir.

You very much Rick I guess I'll jump in with the Big one that I think is still the overhang for the stock which is the <unk> outlook.

You have 15 billion out there for 2025 and combined Sky <unk>.

Forecast guidance.

Just wondering if you could give us a sense of the puts and takes Scott really doing really well, but some overhangs for limbach.

Rick Gonzalez: And so we now have multiple assets and multiple portfolios to be able to drive growth, and our goal is still what we described to the analysts early on. We expect to see the impact of the LOE on Humira in 23 and immediately be able to grow beyond that starting in 24, returning to growth and sales growth at that point. [inaudible] I would just add that, obviously, with the confidence we have and the dividend increase we announced today, we feel very strong about the long-term outlook.

Is that $15 billion still achievable do you think youre trending above that or do you have to make up a shortfall.

Yeah Jeffrey this is Rick.

Question.

Say is the following if I look at Skywest.

I would tell you that <unk> performance is very very impressive.

Jeff outlined with the in play share is and what the total <unk> Zara and it's very close to passing Humira now.

Which in this short period of time is frankly, a surprise how quickly. It has ramped. So I think that's very positive case, if I look at Rainbow actually the <unk> looks very good right.

Rick Gonzalez: We haven't backed off on the high single-digit growth for 25 and beyond. You look at the portfolio we've assembled, you look at the assets we have today, you look at our pipeline, you look at the BD work we've been doing over the last couple of years with some nice licensing deals, and we still feel very confident about the outlook for this business.

Now we would expect if the label change and restricts a.

The label.

Behind.

T N S.

That will have some impact on the on the frontline patients.

Actions that were capturing now Ed.

And.

And so we will see that impact having said that I would say that when I look at <unk> performance overall, how durable it has been throughout this.

The situation.

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

Well, obviously shift more towards.

Andrew Simon Baum: Thank you. Our next question is from Andrew Baum with Citi. Your line is open, sir. Yeah, thank you. Can you flip back to the other side of Rainbow Sky RISD and just talk to Humira?

Second line patients and beyond which was originally in the plan, but the emphasis would've occurred a year or two later than this well.

We would have driven that we have very good data to be able to support that.

I'd say is if you look at it.

At the indications that we have coming out for these two assets.

Andrew Simon Baum: Could you talk to me about your comfort level with where consensus currently has Humira pegged and the anticipated scale and scope of the erosion? And then second, in relation to your ongoing Arditech pending court case, could you just confirm whether, if they prevail, that would effectively invalidate the signed settlement with the other biosimilar players, meaning that you would have a number of players coming much quicker onto the market with anticipated price and volume impacts? Thank you.

Which is a very significant opportunity for us we have TSA.

<unk> is a very significant opportunity, but next year, we have the IBD indications that are coming out and I'd say there when we gave the $15 million for gas.

The performance that was in our <unk> target product profile that we had assumed we have outperformed that in the clinical trials that we've submitted and so I think that's a that's a very significant opportunity for us and a significant opportunity for us to outperform having said all of that we don't want to.

Reconfirm the guidance, yet we want to see what the final label looks like from the from the agency.

Rick Gonzalez: Okay, Andrew, this is Rick. So I'll cover the second one, the ALADEC one. I'm going to have Rob cover the first one.

And then we'll be in a position I think to come out and.

Until the Investor community exactly what you're saying.

The only other thing I'd say is.

I think if you go back five six years ago, what we were trying to accomplish with the campaign, we were basically driving the problems with the company build a set of assets that could ultimately significantly.

Rick Gonzalez: Yeah, we've seen movement in terms of consensus numbers since we've given just some... Direction of how to model it. I think right now, consensus in 23, Celsite consensus has about 41% erosion in the U.S. in 23. And we've said, you know, think about it in terms of, you know, 45% based on what we saw in Europe in year one, plus or minus 10%, given the differences in the pair landscape in the US versus other markets. So we have seen the American census move. Today, it's at 41%.

Replace humira in the marketplace and be superior to Humira and these two assets already are at $5 billion and growing very rapidly.

So I think everything I know about these two assets there'll be able to do exactly what we expected of them.

Even in the most.

Negative outcome from a label standpoint that we would expect second opinions, we built a significant.

He Ma portfolio that when I look at the pipeline behind them <unk> I think there's a significant opportunity.

Drive.

Significant growth in that portfolio, and then with the Allergan acquisition I couldnt be more pleased and aesthetics franchise is performing outstanding level. The neuroscience franchise is performing outstanding level I think migraine.

Rick Gonzalez: So it's a lot closer than it was the year before. Okay, Andrew, this is Rick. I'll cover the Alvitek situation. So, as you know, we're in litigation with Alvitek. I think it's important to understand the nuances behind that litigation. So in this first set of litigation, this first wave of litigation, we are basically applying 10 patents in Numera. And as you know, we have a very robust patent portfolio around, but these 10 patents are both formulation patents and indication patents.

Is a very significant opportunity for us to be able to drive and here's another one and so we now have multiple assets and multiple portfolios to be able to drive the growth. Our goal is still what we've described to the animals.

Early on we.

We expect.

To see the impact of yellow on Humira in 'twenty, three and immediately be able to grow beyond that starting in 'twenty four returned to growth sales growth at that point and regardless of what happens with <unk> label.

Rick Gonzalez: Many of these patents were challenged through the IPR process and upheld by the Patent Office, so it gives you some idea of the strength of these patents. So the first thing I'd say to you is that we have a high level of confidence that we will prevail in this election. There will be a second wave of litigation that occurs after that, which will bring into the portfolio the rest of the patents that we think ALBATEK infringes.

I have a high level of confidence we can continue to do that.

Rob anything you'd add.

I would just I would just add that obviously with the confidence we have in the dividend increase we announced today, we feel very strongly about the long term outlook, we havent backed off on the high single digit growth 25, and beyond when you look at the portfolio. We've assembled if you look at the assets. We have today you look at our pipeline. We look at the BD work, we've been doing over the last couple of years.

Rick Gonzalez: So there could be another phase of litigation that occurs after this one. But I can tell you we're highly confident that we will prevail in this first set of litigation, to specifically answer your question. If they were to prevail, which I don't believe they will, then it would accelerate the other patent settlement.

<unk> had some nice licensing deals and we still feel very confident outlook for this business.

Chris Schott: Thank you, Andrew. Operator, next question, please. Thank you. This call comes from Chris Schott with J.P. Morgan. Your line is open, sir.

Alright, thank you.

Thanks, Geoffrey Operator next question please.

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

Chris Schott: All right, great. Thanks so much.

Yes. Thank you could you flip back to the other side to really focus kind of risky and just took that humira could you talk to your comfort level with where consensus currently has humira pegged and the anticipated scale and scope of the erosion and then second.

Chris Schott: Just one quick follow-up on RINVOC and the upcoming indications. Do you see a scenario where you are unable to get the drug approved in these pending indications, particularly AD, over the next few months? Or is your view, based on all the interactions, et cetera, that this is largely, I guess, a label and maybe line of therapy kind of discussion and decision with the agency?

In relation to your ongoing alphatec.

Pending court case could you just confirm whether if they prevail that would effectively empower today, we signed settlements with the other biosimilar players, meaning that you would have a number of clients cutting that much quicker onto the market with anticipated price and volume impacts.

Chris Schott: And my second question was on Botox aesthetics. Very healthy growth you're seeing here. We're now coming up against some more normalized comps, and you're still seeing the growth rate very, very healthy. Are we still seeing catch-up usage in this, or is this just really underlying demand at this point? And just a little bit more color about just how you're thinking about the nearer term growth trajectory. I know you talked about high single digits over time, but just as we may look out to 22, 23, could this remain kind of a mid-teens type of growth rate product over that window? Thanks so much.

Okay. Andrew This is Rick so I'll cover the second one on the Alphatec, one I'm going to have Rob.

Cover the first one yes, we've seen movement in terms of consensus numbers since we've given just some.

The direction of how to model. It I think right now consensus in 'twenty three sell side consensus is about 41% erosion.

In the U S and 23, and we've said.

Mike: Mike. Okay, thanks, Chris. This is Mike. I'll, I'll take the first one.

Think about it in terms of 45% based on what we saw in Europe in year, one plus or minus 10% given the differences in.

Rick Gonzalez: And then Rick will take the second part of your question. With respect to RINVOKE and the three new indications, so psoriatic arthritis, atopic dermatitis, and ankylosing spondylitis, we remain very confident in those files, and we remain very confident in approval decisions. The gaining factor here is really getting to the specifics of the language around RA, which is a process that is well underway. And we would expect to be in a position to gain approvals after that is completed, and again, we hope that it is completed in the near future, certainly this year. The psoriatic arthritis and atopic dermatitis findings will follow, you know, fairly closely on the heels of that RA decision for ankylosing spondylitis.

The payer landscape.

In the U S versus other markets. So we have seen the humira consensus move today, it's at 41%. So it's a lot closer than it was a year ago.

Andrew This is Rick I'll cover the Alphatec situation. So as you know we're in litigation with Alphatec.

I think it is important to understand the.

The nuances behind that litigation. So in this first set of litigation. This first wave of litigation we are.

We are basically applying 10 patents and Humira and as you know we have a very robust patent portfolio around humira.

Rick Gonzalez: As I mentioned in my prepared remarks, we've rolled in a new study, which is a positive study and a very strong study in ankylosing spondylitis, into that submission. And so that one might be on a slightly different timeframe, but we remain very confident in that approach. This is Rick on Botox.

But these 10 patents are both formulation patents and indication patents. Many of these patents at were challenged through the IPR the IPR process and upheld by the patent office. So it gives you some idea of the strength of these patents. So the first thing I'd say to you is we have a high level of confidence.

Rick Gonzalez: Yeah, I think one of the things when we first went through the integration process that was compelling to us was the amount of penetration in these markets and Allergan's ability to reach out and touch consumers and activate those. And that's part of what drove our decision globally to go with this fully integrated, you know, totally dedicated aesthetics organization because in many other markets around the world, although the data is not quite as good as it is here in the US, but in China, as an example, you see very similar kinds of dynamics. And so focusing that team purely on aesthetics was part of the effort here to be able to accelerate the process.

That we will prevail in this litigation there will be a second wave of litigation that occurs after that which will.

Which will bring into the portfolio the rest of the patents that we think Alphatec infringes.

So there could be another phase of litigation that occurs after this one but I can tell you. We're highly confident that we will prevail in this first settled litigation based on the strength of those patents to specifically answer your question.

If they were to prevail, which I don't believe they will.

Then it would accelerate the other patent settlements, yes that is correct.

Thank you Andrew Operator next question please.

Thank you it comes from Chris Schott with Jpmorgan. Your line is open Sir alright.

Alright, great. Thanks, so much just one quick follow up on <unk> and the upcoming indications.

Rick Gonzalez: The second was when we looked at the ability to be able to use various methods to be able to activate consumers; we believe that the business was being underfunded in a way, both in the way it was being funded and the total amount that it was. And so we did some early work to determine whether or not that funding could drive incremental market growth, and it showed a positive result. And then when we saw that, we applied for significantly greater funding.

Do you see a scenario, where you are unable to get the drug approved and these pending indications, particularly a D. Over the next few months or is your view based on all of the interactions et cetera that this is largely because our label and maybe line of therapy kind of discussion and decision with the agency.

And then my second question was on Botox aesthetics, very healthy growth Youre seeing here, we're now coming up against even some more normalized comps and youre still seeing the growth rate.

Rick Gonzalez: And what you're actually seeing now, I think, is that we are driving the market. We're bringing more patients into the category. And obviously, because we have the leadership position from a market share standpoint, and we get the vast majority of those pages, is there still some pent up demand? I would tell you it's hard to believe at this point that there can be a lot of it, but there has to be some of it, right?

Very very healthy.

Are we still seeing catch up usage in this or is this just really underlying demand at this point and just a little bit more color, but just how youre thinking about kind of the near term growth trajectory. I know you talked about high single digits over time, but just asking me to look out to 'twenty two 'twenty three could this remain kind of a you know.

Rick Gonzalez: Because remember, those practices will reopen in the US in the summer of 2020. So that's a long time to have pent-up demand, but it's impossible to tell one way or another. So I would say the majority of it is certainly being driven by us activating patients and retaining more patients. One of the other things we saw was that the retention rate was relatively low once you activated a patient. And so we spent some time working with the team to figure out how you could retain those patients at a higher rate, meaning they repeat their procedures. They don't just do it once and then disappear, but they come back for second procedures or cross go into fillers, as an example.

Mid teens type of growth rate product over over that window. Thanks, so much.

Okay. Thanks, Chris This is Mike <unk>.

I'll take the first one and then Rick will take the second part of your question with respect to <unk> and the three new indications psoriatic arthritis, atopic dermatitis and ankylosing spondylitis, we remain very confident in those files and we remain very confident in approval decisions.

The gating factor here is really getting to the specifics of the language around <unk>, which is a process that is well underway and.

Rick Gonzalez: So the data is very clear. If you look at the U.S. as an example, toxins and fillers are growing at a high rate of 30% of the market. We're growing at about the same rate, maybe a little bit lower on fillers, but about that rate on toxins.

And we would expect to be in a position.

To gain approvals.

After that is completed and again, we hope that's completed.

The near future certainly certainly this year.

The psoriatic arthritis, and atopic dermatitis filings, we would expect to follow fairly closely on the heels of that or a decision for ankylosing spondylitis as I mentioned in my prepared remarks, we've rolled in a new study, which is a positive study in a very strong study in ankylosing spondylitis into that submission and so that one might be on a slightly different timeframe, but we.

Rick Gonzalez: When we look globally, the overall brands are growing at about that rate, and so I think this is a business that is sustainable over the long term. When we say across the decade, high single digits, obviously, if we keep this growth rate, the business is getting bigger and bigger. So, therefore, the percentage will come down a bit. But I tell you, I'm very optimistic about this market and our ability to be able to bring new assets into this market that can change the standard of care going forward as being able to drive market growth. It's very good.

Remain very confident in that approval as well.

Okay.

As Rick on Botox.

I think one of the things when we first went through the integration process that was compelling to US was the amount of penetration in these markets and allergens ability to be able to reach out and touch consumers and activate those consumers.

Chris: Chris. Operator, we'll take the next question, please. Thank you. That comes from Tim Anderson with Wolf Research. Your line is open, sir. Thank you.

And that's part of what drove our decision globally to go with this fully integrated.

Totally dedicated aesthetics organization because in many other markets around the world. Although the data is not quite as good as it is here in the U S or in China. As an example, you see very similar kinds of dynamics and so focusing that team purely on aesthetics was was part of the effort here to be able to drive accelerated growth the circa.

Timothy Minton Anderson: Thank you. I wanted to ask a question on Humira in 2023. I'm just really trying to nail down what's in that. Erosion Guidance of 45% plus or minus. That's sail erosion, not volume. I'm trying to think through what happened.

It was when we looked at the ability to be able to.

Use various methods to be able to activate consumers.

We believe that the business was being underfunded.

In a way.

Both in the way it was being funded in the total amount that was being funded and so we did some early work to determine whether or not that funding could drive incremental market growth and it showed a positive result, and then when we saw that we applied significantly greater funding to it.

Timothy Minton Anderson: 2023, which is likely in the billions of dollars. Do you think you'll retain favorable formulary positioning even with biosimilars? In which case, you would pay that rebate, but you also would have less volume.

And what Youre actually seeing now I think is we are driving the market, we're bringing more patients into the category and obviously because we have the leadership position from a market share standpoint, we get.

The vast majority of those patients.

Timothy Minton Anderson: Do you think it becomes disadvantaged on formulary, in which case you pull back those billions of dollars? And that flows through to the bottom line. Me, I just wonder if your guidance on erosion is frank. [inaudible] So Tim, this is Rick.

Is there still some.

Pent up demand I would tell you it's hard to believe at this point that there can be a lot of it but there has to be some of it right. As you remember those practices reopened in the U S. In the summer of 2020. So that's a long time to have pent up demand, but it's impossible to tell one way or another so I would say that.

Rick Gonzalez: Maybe Rob and I will tag team this one. I'll start. I think the guidance we laid out of 45% or 48%, whichever is the latest number, plus or minus 10%, is still guidance that we feel pretty confident about. To your point about whether the bulk of it is price, it is.

A majority of it is certainly being driven by us activating patients.

And retaining more patients one of the other things we saw was the <unk>.

Retention rate was relatively low once you activated a patient and so we spent some time working with the team to figure out how could you retain those patients at a higher rate, meaning the rupee.

Rick Gonzalez: Even if you look at the international markets, it's about one third, two-thirds, and maybe slightly higher than, I mean, two-thirds of its price; one-third of it is buy-in. And I would expect that we will maintain a significant part of the volume. Obviously, you know, we don't talk publicly about what our managed care strategy is. But what I would tell you is we're close enough now to that 23 timeframe that you would expect us to be starting the work to ensure formulary access for all of our products, and certainly Humira is one of those, for 2023.

Procedures. They don't just do it once and then disappear, but they come back for a second procedure or cross.

Go into pillars as an example.

So the data is very clear if you look at the U S. As an example, toxins and pillars of growing a high 30% of the market.

We're growing at about the same rate.

Maybe a little bit lower on pillars, but about that rate on <unk> when we look at globally.

The overall brands are growing at about that rate and so I think this is a business that is sustainable over the long term when we say across the decade high single digits. Obviously, if we keep this growth rate the business is getting bigger and bigger.

So therefore, the percentage will come down a bit but I'd tell you I'm very optimistic about this market.

And our ability to be able to bring new assets into this market. They can change the standard of care going forward as being able to drive market growth at the same time, it's a very good business.

Rick Gonzalez: You know, I think it is logical to assume that we want to maintain that formulary position. And we've been pretty effective at doing that historically. So I believe we'll be pretty effective at doing it. Rob, anything you want to add?

Thank you Chris Operator, we'll take the next question. Please.

Thank you that comes from Tim Anderson with Wolfe Research. Your line is open Sir.

Thank you I wanted to ask a question on Humira in 2023.

Robert A. Michael: Just as a reminder, I mean, we gave you that, we were using Europe as an analog, but keep in mind that, you know, the U.S. system is very, very different, which is why we gave you a range. And so, as we get closer to 23, obviously, we'll give you more specific guidance on the U.S., but we were communicating as more, you know, directional information based on the experience we saw with Keep in mind, there were four biosimilars that came into the market at that time; there'll be more biosimilars coming into the U.S. markets; there's a different level of competitive intensity.

And just really trying to nail down what's in that.

Erosion guidance of 45% plus or minus 10, that's sales erosion not volume correct.

I'm trying to think through what happens to the U S rebate stream and.

In 2023, which is likely in the billions of dollars do you think youll retain favorable formulary positioning even with Biosimilars in which case you keep paying that rebate, but you also would have less volume loss.

Or do you think that becomes disadvantage on formulary.

In which case you pulled back those billions of dollars in rebates.

And that flows through to the bottom line to me I just wonder if your guidance on erosion.

Just frankly, too conservative or too aggressive because those rebate dynamics in the U S. They make us a more durable market ex U S for those rebate dynamics.

Jim: Thank you, Jim. Operator, next question, please. Thank you. This comes from Gary Nachman with BMO Capital Market. Your line is open, sir.

Okay.

Tim This is Rick maybe Rob and I will tag team. This one.

I'll start.

Gary Jay Nachman: Thanks. Good morning. A couple on neuro that had some recent wins.

I think the guidance, we laid out of 45 or 48% whichever is the latest number plus or minus 10% is still a guidance that we feel pretty comfortable with to your point about is the bulk of it price. It is.

Gary Jay Nachman: So first on VRELAR and the phase three studies in MDD. In one study, you hit on the one and a half milligram dose but not the three milligram dose. It was close, but not statistically significant. So will that matter to the FDA? Maybe, you know, you could remind us what doses hit in the previous phase three. And now that you have the full data set, how do you think VRELAR will stack up competitively in the MDD space?

Even if you look at the international markets. It's about one third two thirds and maybe slightly higher than that.

Two thirds of it surprise one third of it is volume and I would expect that we will maintain a significant part of the volume.

Obviously, we don't talk publicly about what our managed care strategy is but what I would tell you is we're close enough now in to that 'twenty. Three time frame that you would expect us to be starting the work to ensure formulary access on all of our products and certainly.

Gary Jay Nachman: And then just quickly on migraine, you know, a little bit more about how the initial launch went for Tulipta and how that has been rolled into the Botox and Ubrelvi offering, and just your confidence about the reimbursement you said going into the first half of next year. Thanks. Okay, this is Mike.

There's one of those fleets.

For 2023 and.

I think it is logical to assume that we will maintain that formulary position.

And we've been pretty effective at doing that historically, so I believe we will be putting your effective at doing that again.

Mike: I'll take the first part of your question, and then Geoff will take the second part of your question. With respect to Braylor MDD, in the study that you described, the 1.5 milligram dose met its end point, and it met it with a highly statistically significant p-value of.005, so.005. And that's important in terms of the strength of the evidence overall and the weight of the evidence overall. And then, as you point out, in the 3-milligram arm of that same study, we didn't reach significance, but we had a p-value that was very small.

Rob anything you want to add just as a reminder, I mean, so we gave that we were using Europe as an analog but keep in mind that the U S system is very very different. This is why we gave you a range and so as we get closer to 23, obviously, we'll give more specific guidance on the U S. But we are communicating is more directional information based on the experience we saw with the ERP mind there were four.

Our biosimilars that came to market that time there'll be more biosimilars come into U S markets, there's a different level of competitive intensity.

But also it's a very different payer landscape. So it's something to keep in mind.

Okay. Thank you.

Thank you Tim.

Operator next question please.

It comes from Gary Nachman with BMO capital markets. Your line is open Sir.

Mike: The nominal p-value was.073, if we round. So, when you look at that overall study, to our eye, it clearly shows an effect of MDD. Now, the second phase 3 study that we just read out did not reach statistical significance for either dose group, but there were favorable trends, and across a number of comparisons, there were nominal p-values that were quite small, and many of them were lower than.05. And I'll just remind the listeners that it's very common in depression studies, even with classes of medicines that have firmly established efficacy, to have some studies that read out positive, and some studies that are negative.

Thanks, Good morning, a couple on there that had some recent wins so first on <unk> the phase III studies in MTBE.

One study you hit on the one and a half milligram dose, but not the three milligram dose there was close but not statistically significant.

Will that matter to the FDA, maybe you could remind us what those is hitting the previous phase three.

Now that you have the full data set how do you think rail or will stack up competitively in the <unk> space.

And then just quickly on migraine.

Little bit more how the initial launch has gone for it she left.

How has that rolled into the bowtie can you brought the offering.

Mike: And so, we think that the overall package that we announced today is very strong. And it's also important to keep in mind that we did have a prior study that was conducted several years ago that was also positive and demonstrated a statistically significant effect. Now, that study looked at slightly different doses. There were dose ranges that were studied in that trial with titration.

And just your confidence about the reimbursement you said going into the first half of next year. Thanks.

Okay. This is Mike I'll take the first part of your question and then Jeff will take the second part of your question.

With respect to <unk>.

In the study.

That you described the one five milligram dose.

<unk> 10 point and embed it with a highly statistically significant P value of <unk>.

Mike: It was the upper two of the dose ranges that was significant, but they did show both a clinically meaningful and significant benefit. So, we had two positive studies, and that's important because the way these studies are typically looked at is by an overall weight of evidence. Do you have a convincingly positive phase 3 study, and is there other evidence within the overall data package that is supportive, and do we feel comfortable that that is the case here?

0.005, so double-o five.

And that's important.

In terms of strength of evidence overall and weight of evidence overall and then as you point out.

In the three milligram arm and that same study we didn't hit significance, but we had a P value that was very small with a nominal P value was <unk> seven.

Three.

If we round so when you look at that overall study.

Mike: And lastly, what I'd say is if you look at the precedent and you look at other approvals, findings like the ones that we described are not at all uncommon. In fact, I think they're very common amongst approved agents in this space, including some of the more recent approvals in adjunct at MDD. So, overall, we think it is a strong package that has a viable regulatory pathway, and we'll stack up, you know, very nicely to competitors, and we're going to begin those regulatory discussions shortly. So, with that, I'll turn it over to Geoff. Yeah. Thank you, Mike.

It clearly shows and in fact, an M D D.

Now the second phase III study that we just read out.

Did not reach statistical significance for either dose group, but there were favorable trends.

And across a number of comparisons that were nominal P values that were quite small and many of them were lower than points.

Zero five.

And I'll just remind the listeners that it's very common.

In depression studies, even with classes of medicines that have firmly established efficacy to have some studies that read out positive and some studies that are negative and so we think that overall package that we announced today is very strong and it's also important to keep in mind that we did have a prior study.

Mike: Look, it's a meaningful opportunity for sure. When we look at the market sizes, about 60 million total prescriptions for the adjunctive MDD market, and that's very similar to the bipolar market that we operate in now. So, it's a very meaningful opportunity for us. If you think about what Mike was saying in terms of the competitive profile, I think we have to remember that while it's got a fairly low share, Braylor is very attractive, which is why it's the fastest growing agent.

That was conducted several years ago.

That was also positive that demonstrated a statistically significant effect and that study looked at slightly different dosing there were dose ranges.

That were studied.

In that trial with titration. It was the upper two of the dose ranges.

It was significant but it did show both at clinically meaningful insignificant benefits. So we had two positive studies and that's important because the way. These studies are typically looked at as an overall weight of evidence do.

Do you have a convincingly positive phase III study and is there other evidence with within the overall data package that is supportive and we feel comfortable that that is the case here.

Mike: So, the efficacy is viewed very, very favorably overall, and I think that, you know, if approved, this also has competitive efficacy, a very gentle metabolic profile, minimal weight gain, very tolerable, and also very simple dosing for the psychiatrists and the primary care doctors that look at this. So, when you start to see the potential for an agent like Braylor that's got the full spectrum across bipolar disease in terms of mania, mixed episodes, and depression, and if approved, it will be very attractive. So we anticipate a nice catalyst here and certainly a nice add to Raylar's overall. If you want to cover the second question, Yeah, perfect.

And.

Lastly, what I'd say is if you look at the precedent and you look at other approvals findings like the ones that we described are not at all uncommon in fact, I think they're very common amongst approved agents in this space, including some of the more recent approvals in adjunct at M. D D like Brooks halting.

So overall, we think it is.

A strong package.

That has a viable regulatory pathway and will stack up.

Very nicely to competitors and we're going to begin those regulatory discussions shortly so with that I'll turn it over to Jeff Yes. Thank you Mike look it's a it's a meaningful opportunity for sure when we look at the market sizes.

$60 million in total prescriptions for the adjunctive MTBE market and that's very similar to the bipolar market that we operate in now so it's it's it's a very meaningful opportunity for us. If you think about the what Mike was saying in terms of the competitive profile.

Geoff: The second question you had was about QLIPDA. And QLIPDA, it's very early. We just introduced the product with our full commercial promotion. As I mentioned in my prepared remarks, we now, as of this quarter, have a dedicated migraine sales force, which shows you how important we think that this franchise is and what we can do with this franchise. So we have an entire sales team out there that is launching QLIPDA and is now also focused on Ubrelvi.

I think we have to remember that while it's got a fairly low share.

<unk>, a very large very attractive which is why it's the fastest growing agents. So the efficacy is viewed very very nicely overall and I think that.

If approved this also has competitive efficacy a very gentle metabolic profile minimal weight gain very tolerable and also very simple dosing for the psychiatrist in the in the primary care doctors that look at this so when you start to see the potential for an <unk>.

Geoff: And the early feedback has been very strong. What we hear qualitatively from our field and certainly from our research in the first few weeks of launch is, first, the simplicity and strength of QLIPDA for prevention. We see a very, very nice response to our efficacy data, which, as Mike has said before and I've said before, is on the very high end of preventative performance. So 60% of patients in our trials achieved a greater than 50% reduction in migraine days, which is viewed as very significant.

<unk> like <unk>, that's got the full spectrum across bipolar disease.

A mania mixed episodes in depression, and then the adjunctive depression indication.

If approved it will be very attractive. So we anticipate a nice catalyst here and certainly a nice add to <unk> overall profile.

If you want to cover the second question, Yes, perfect. The second question you had was.

Was Q lifter and COO lift.

Very early we just introduced the product with our full commercial promotion as I mentioned in my prepared remarks, we have now as of this quarter a dedicated migraine salesforce, which shows you how important we think that this franchise is and what we can do with this franchise. So we have an entire sales team out.

Geoff: And almost 30% have complete control, a 100% decrease in their migraine days. So that's very compelling in terms of this QLIPDA power. Also, physicians like the simple, everyday dosing once a day, and so things are quite strong in terms of our early qualitative feedback. So we do obviously anticipate that the majority of our prescriptions will be bridge prescriptions until we get the fuller ramp of our market access, which, as I mentioned, we're quite confident by the first half of the year, we should ramp up similar to Ubrelvi where, ultimately, as you remember, we achieved about 90% accuracy. So, quite good early feedback on the launch. And again, we think that the three assets together are a unique competitive position.

There that is launching Q lifter and now also focused on <unk> and the early feedback has been very strong what we hear qualitatively from our field and certainly from our research in the first few weeks of launch is first the simplicity and strength of Q Liptak for prevention.

We see very very nice response to our efficacy data, which as Mike has said before and Ive said before is on the very high end of preventative performance. So 60% of patients in our trials achieved a greater than 50% reduction in migraine days, which is viewed as very significant and almost <unk>.

Gary: Thank you, Gary. Operator, next question, please. Our next question is from Matthew Harrison with Morgan Stanley. Your line is open, sir.

30%.

<unk> control, 100% decrease in their migraine days. So that's a very compelling in terms of this Q lift power also physicians like the simple everyday dosing once a day and so things are are.

Matthew Harrison: Great. Good morning.

Matthew Harrison: Thanks for taking the questions. I guess two for me. So one, if I could just follow up on CGRP. I'm curious. Obviously, you have a different strategy than your competitor when it comes to the prophylactic market. I'm just wondering where your sources of patients are going to come from. Are you expecting more transitions from injectables? Or do you think they're going to be more de novo patients? And if you could just talk about that a little bit.

Are quite strong in terms of our early qualitative feedback. So we do obviously anticipate that the majority of our of our prescriptions will be.

<unk> prescriptions until our we get the full ramp of our market access, which as I mentioned, we're quite confident by the first half of the year, we should ramp similar to <unk>, where ultimately as you remember we achieved about a 90% access in the U S. So quite good early feedback on the launch.

And again, we think that the three assets together, our unique competitive positioning for Abbvie.

Matthew Harrison: And then, secondly, on Regenexx, could you just talk about your confidence in the data there? Obviously, there was some inflammation there, though it did seem self-limiting. I'm just curious how you think about that and how you think about that impacting the profile, because obviously, in other gene therapy products in the eye, inflammation has sometimes proven to be pretty significant as a long-term sequelae. Thanks. Yeah, I'll take the first one.

Thank you Gary Operator next question please.

Our next question is from Matthew Harrison with Morgan Stanley. Your line is open Sir.

Great. Good morning, Thanks for taking the questions I guess two for me so I wonder if I could just follow up on <unk>.

<unk> I'm curious, obviously you have a different strategy than your competitor when it comes to the prophylactic market I'm. Just wondering how you think where your sources of patients are going to come from are you expecting more transitions from injectable or do you think theyre going to be more de novo patients and if you could just talk about that.

A little bit and then <unk>.

On <unk> could you just talk about.

Your confidence in the data there obviously there was some inflammation there, though it did seem self limiting I'm just curious how you think about that and how you think about that.

Mike: Thanks. So in terms of the source of business, we think that QLIPDA is going to get business from two primary areas. First is, you know, the big headache specialist, the big neurologist. We think, absolutely, from our research and feedback, that you'll start to see an early trade-off of the injectable MABS in favor of the orals and certainly in favor of QLIPDA. I think that this is viewed as very

Impacting the profile because obviously in other gene therapy products in the eye inflammation.

It has sometimes a proven to be pretty significant as a long term supply.

Yes, I'll take the first one thanks, so in terms of the source of business, we think that <unk>.

Is going to source business from from two primary areas first is.

The big headache specialists, the big Neurologists, we think absolutely from a research and feedback that youll start to see an early trade off of the injectable maps in favor of the oracles and certainly in favor of <unk> I think that this is this is viewed as very attractive in many in many cases some <unk>.

Mike: In many cases, some people have spontaneously highlighted, wow, it looks like a very strong MAB in a single oral pill. So that's a source of business in terms of market share trade-off. I think the other insight that we have from the market is that, you know, we are going to call on a substantial amount of high prescribing primary care physicians who don't write a lot of MABs, but they certainly write a lot of generic topiramate and some other older agents.

We'll have spontaneously highlighted while it looks like a very strong mab and in a single oral pill. So that's a source of business in terms of market share trade off I think the others. Other insight that we have from the market is that we are going to a calling on a substantial amount of high prescribing.

Primary care physicians, who don't write a lot of maps, but they certainly right a lot of generic topiramate and some other older agents and so we also see that we have a unique opportunity in a wider audience to source from physicians that really don't lean towards the maps because of the injectable nature of those et cetera. So.

Mike: And so we also see that we have a unique opportunity to reach a wider audience to source from physicians that really don't lean towards MABs because of the injectable nature of those, etc. So we think we're going to have a good balance between those two sources of business, and that's quite attractive. So, this is Mike.

We think we're going to have a good balance between those two sources of business and and that's quite attractive for us right now.

So this is Mike I'll take the question regarding Regenesis, we're very encouraged by the recent data if we take a step back and look at the program overall they have.

Mike: I'll take the question regarding Regenexx. We're very encouraged by the recent data. If we take a step back and look at the program overall, they have very strong efficacy data already demonstrated with subretinal delivery. Now, that's an OR procedure, but it gives clear proof of concept for the approach and shows that we can get durable control.

Very strong efficacy data already demonstrated with sub retinal delivery now that's in <unk>.

Or procedure, but it gives clear.

Proof of concept.

For the approach and shows that we can get durable control.

Mike: And that component of the program is already in Phase 3. And then the more recent data that were presented just about a month ago, several weeks ago, looked at supracaroidal delivery. So, that is a delivery method that can be done in the office.

In that component of the program is already in phase III and then the more recent data that were presented.

Just about a month ago.

Several weeks ago looked at Super Choroidal deliveries. So that is a delivery method that can be done in office.

Mike: It's a specialized form of injection, but it is an injection. And that is also showing very good promise. We're already seeing signs of efficacy in the first cohort, which is the lowest dose cohort, which, you know, quite frankly, is sooner than we expected to see them before that study had started to deliver results. And the tolerability is very good. If one looks at the inflammation that is reported in the Regenexx trials, it's very different in its nature and its severity than that that has been seen with other agents. It's principally an anterior chamber or exclusively an anterior chamber.

It's a specialized form of injection, but it is a form of injection and that is also showing very good promise, we're already seeing signs of efficacy in the first cohort.

Is the lowest dose cohort, which quite frankly is sooner than we expected to see them.

Before that study.

Had started to deliver results in the Tolerability.

<unk> is very good.

If one looks at the inflammation that is reported in the Regenesis trials, it's very different in its nature and its severity than that that has been seen with other agents, it's principally anterior chamber exclusively anterior chamber Theres no vasculitis no.

Mike: There's no vasculitis, no more significant inflammation. It is readily treated with topical steroids and generally resolves without any difficulty and, in fact, quite rapidly. And it's also important to remember that there are no prophylactic steroids being used here, although other approaches have required them. So these are patients who have no prophylaxis up front and are responding to what's often a brief course of topical steroids. And the reason why there are no prophylactic steroids given is that they're just not felt to be needed given the very mild nature of the inflammation that's being observed.

More significant inflammation.

It is readily treated.

With topical steroids.

And.

Generally resolves without.

Without any difficulty and in fact quite rapidly.

Also important to remember that there's no prophylactic steroids being used here other approaches have required that so these are patients who have no prophylaxis upfront and are responding to.

That's often a brief course of <unk>.

Topical steroids.

And the reason why there's no prophylactic steroids, given us or Theyre, just not felt to be needed given the very.

Mild.

The nature of the inflammation that is being observed so we're very confident with it and again, we feel it's qualitative qualitatively very different.

Mike: So we're very confident in it, and again, we feel it's qualitatively very different from what has been seen in other agents. And we've obviously talked to retinal specialists as well, who are quite familiar with the program. And the views we've heard from them are supportive of what I just said.

And then what has been seen in other agents in and we've obviously talked to retinal specialists as well who are quite familiar with the program.

And the views we've heard from them are supportive of what I just described.

Matthew: Thank you, Matthew. Operator, next question, please. Thank you. Our next question is from Steve Scala with Cowan. Your line is open, sir. Thank you.

Thank you Matthew Operator next question please.

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

Steve Scala: Thank you. I have a few questions, a couple of follow-ups, but how would you describe the nature and the tone of the conversations with FDA regarding Renvoke's new label, NRA? Would you say you're pleased with how things are going?

Thank you I have a few questions a couple of follow ups, but how would you describe the nature and the tone of conversations with FDA regarding <unk> New label NRA would you say youre pleased with how things are going is the outcome unclear to abbvie at this juncture or is the outcome obvious sent in.

Steve Scala: Is the outcome unclear to AbbVie at this juncture, or is the outcome obvious and in line with what the FDA said in its statement in September? So that's the first question. Second question, to my knowledge, Raylar has shown superiority to placebo but not generics in MDD. So how would AbbVie establish it as a leading MDD agent, given the presence of lower-cost alternatives? And, lastly, any thoughts on the Soliton acquisition relative to its closing? Thank you. Okay, this is Mike. I'll start.

Align with what the FDA had in its statement in September. So that's the first question second question to my knowledge <unk> has shown superiority to placebo, but not generics in M. D. D. So how would abbvie establish it as a leading MDT agent given the presence of lower cost alternatives.

And then lastly, any thoughts on the solid tonne.

Acquisition relative to its closing thank you.

Okay. This is Mike I'll start and then Rick will take the question regarding solar time.

Mike: And then Rick will take the question regarding Soliton. You know, with respect to the tone of conversations with the FDA on Randolph's behalf, I would describe them as productive. With respect to your question specifically about the RA label, those those those discussions are productive as well. You know, I would assume the base case is what they announced conceptually back in early September. But We are working through the specifics of how that translates into labeling language.

With respect to the tone of conversations with the FDA for Rainbow I would describe them as productive with respect to your <unk>.

Question, specifically about the <unk> label those those those discussions are productive as well.

I would assume the base case is is what they announced.

And separately.

Back in early September, but we are working through the specifics of how that translates.

Two labeling language and I would characterize the discussions around the other indications as being <unk>.

Mike: And I would characterize the discussions around the other indications as being very productive and very positive as well. And so, you know, as I mentioned earlier in this call, we remain very confident in the files for those new indications for all three of them. With respect to RALAR, head-to-head superiority studies are not typically done in this space, and they're very challenging.

Very productive and very positive as well and so.

As I mentioned earlier in this call we remain very confident in the files for those.

For those new indications for all three of them.

With respect of railcar.

<unk> superiority studies are not typically done in this space Theyre very challenging it is challenging to show an impact even with established classes period in major depressive disorder, and particularly in this space because.

Mike: It is challenging to show an impact even with established classes, period, in major depressive disorder, and particularly in this space, because this is adjunctive treatment for major depressive disorder. So these are patients who aren't responding to the current therapies and require an add-on, and atypical antipsychotics with pharmacology similar to RALAR are one of the most commonly used agents in this space. So we think the very strong data that we have from the study that we described and the fact that we have prior supportive evidence as well from the earlier study will position it very well to be competitive in that. And Steve, it's Geoff.

This is the adjunct treatment of major depressive disorder. So these are patients who aren't responding to.

The current therapies and require an add on and atypical anti psychotics with pharmacology similar to <unk> or one of the most commonly used agents in this space. So we think the very strong data that we have.

From the study that we described and the fact that we have prior supportive evidence as well from from the earlier study will position it very well to be got to be competitive in that marketplace and Steve. It's Jeff just that just to build on Mike's point I mean, if you think about the size of radar now approaching $1 $8 billion as it is a two and a half share in.

Geoff: Just to build on Mike's point, I mean, if you think about the size of Raylar now, approaching $1.8 billion, it has a two and a half share in terms of the antipsychotic market. So it's a low share, you know, high value and growth area. So when you think about most of our business, most of our business is already stepping through, in some cases, one or two of the generics. The problem is that these patients are so fragile; they just don't respond well.

Of the antipsychotic market, so it's low share high value and growth area. So when you think about.

Most of our most of our business is already stepped through in some cases, one or two of the generics. The problem is that these patients are so fragile. They just they just don't respond well so we would still anticipate that.

Geoff: So we would still anticipate that, you know, with the new approval for AMD, you're still going to have step therapy and other approaches in the marketplace, but that there's still a very, very, very nice commercial opportunity. That's just the way the markets work today. So this is Rick, Steve.

With the approval with new approval for AMD, you are still going to have step therapy and other approaches in the marketplace, but that there is still a very very.

Very nice commercial opportunity there that's just the way the markets work today.

Alright. Thanks.

So this is Rick.

Rick Gonzalez: On Soliton, you know, as you know, we obviously announced our intention to acquire the company and submitted it for approval. We did receive a second request, maybe just to explain a bit why we're interested in this area. You know, we tend to look at this market where the third major leg of the stool in aesthetics is the body tonic. And this is a good fit with Cool Sculpting and Cool Tone. Obviously, Cool Sculpting is focused more on the reduction of fat in targeted areas, and Cool Tone's more focused on the area of enhancing muscle tone. This particular asset is designed to reduce cellulite.

Steve unsold of time as you know, we obviously announced the our intention to acquire the company and submitted for approval. We did receive a second request.

Maybe just to frame a bit why we're interested in this area.

Then we'll look at this market, where the third major leg of the stool and aesthetics as body contouring and this is a good fit with co sculpting.

And Paul tone, obviously cool sculpting is focused more on reduction of fat in targeted areas.

Cool tones more focus on the area.

Enhancing muscle tone.

And.

Pacific areas.

This particular asset is designed to reduce cellulite, we don't have a position in cellulite now.

Rick Gonzalez: We don't have a position in cellulite now, so there's not any kind of competitive overlap in that area. Having said that, we are responding to the FTC's inquiry. We believe that's going reasonably well, so we would expect this to be resolved at some point here in the future. I can't tell you a specific date, but I would expect to have a positive outcome over a period of time here.

So theres not any kind of competitive overlap in that area, having said that we are responding to the FTC's inquiry, we believe that's going reasonably well. So we would expect this to be resolved at some point here in the future I can't tell you a specific date, but I would expect it to have.

A positive outcome.

Steve: Thank you, Steve. Operator, next question, please. Thank you. Our next question is from Vamil Divan.

Over a period of time here.

Thank you Keith Operator next question please.

Thank you. Our next question is from the mill Divan with Mizuho Securities. Your line is open.

Vamil Kishore Divan: Mizzou Securities, your line is open. Great, thanks so much for taking my question. So just maybe one more on Ray Lahr following up on the other comments. I think before you talked about this being maybe a sort of multi-billion dollar type opportunity in MDD, is that still sort of the lines you're thinking now that you've seen the data that you disclosed today? And then the second one, just going

Great. Thanks, so much for taking my question. So just.

Maybe one more just on <unk> following up on the other comment I think before you had talked about as being as maybe it's a multibillion dollar opportunity and MDT.

Is that still sort of the lines you're thinking now that you have seen the data that you disclosed today and then the second one just going back to <unk>.

Jeff: Dr. Renvoke, and it sounds like you're still pretty confident about that.

They are still pretty confident on our products outlook.

Unknown Speaker: Unknown Speaker I'm just curious if that's changed any of your priorities as you think about business development, specifically in immunology, so the need for, you know, maybe look at other oral agents that might be in development there, just so how you're thinking about the broader, you know, BD landscape there. Jeff?

Just curious if thats changed any of your sort of priorities as you think about business development, specifically in immunology sort of a need for maybe look at other oral agents that might be in development. There just sort of how you're thinking about the broader.

BD landscape there. Thank you.

Jeff: Yeah, I think if you if you look at the, as I highlighted, that, you know, the market sizes are roughly the same. However, the competitive context is quite a bit different, and the competitive set is a little bit different. So we view it again as an important, important incremental opportunity that even with a low incremental share that we can drive Raylar to that multi billion dollar guidance that we looked at. We do think it's an incremental catalyst and an exciting approach if it were to be approved. So this is Mike. I'll take the RINVOQ question.

Yeah, Jeff Yeah, I think if you look at the as I highlighted.

That you know.

The market sizes are roughly the same however, the competitive context is quite a bit different than the competitive set is a little bit different. So we view it again as a as an important.

<unk> incremental opportunity that even with with low incremental share that we can we can drive railcar to that multibillion dollar guidance that we looked at it we do think it's an incremental catalyst.

And our next.

Exciting approach if it were to be approved.

So this is Mike I'll take the Rainbow question.

Mike: So, as you point out, yes, we are very confident in RINVOQ as a molecule. Overall, we've talked about the progress on the R.A. indication and our confidence in the new indications, both those that are under review and indications where we have data that have not yet been submitted, like IBD. And so we feel that it's going to be an important part of our portfolio and the treatment arsenal going forward. You know, so having said that, immunology is always an area where we are scouring the landscape to look for the best opportunities.

So as you point out yes, we are very confident in <unk> as a molecule overall, we've talked about.

The progress on the indication and our confidence in the new indications both those that are under review.

And indications, where we have data, but have not yet submitted like the IBD indications and so we feel that it's going to be an important part of our portfolio.

The treatment armamentarium going forward.

Having said that immunology is always an area, where we are scouring the landscape to look to look for the best opportunities. So I wouldn't say, it's changed our focus in any way or changed our approach.

Mike: So I wouldn't say it's changed our focus in any way or changed our approach, but we will continue to look for novel therapies that can raise the bar on the standard of care in a number of areas, current indications where we are already playing and new indications, you know, that have fewer treatment options, areas like lupus and scleroderma. So the RINVO situation has not changed that strategy in any way.

But we will continue to look for novel therapies that can raise the bar on the standard of care across a number of areas. The current indications, where we are already planning and new indications.

That have fewer treatment options areas like lupus and scleroderma so.

The <unk> situation has not changed that strategy in any way.

Vamil: Thanks, Vamil. Operator, we'll take the next question, please.

Thanks, Shlomo operator, we'll take the next question please.

Ronnie Gall: Thank you. It was from Ronnie Gall with Bernstein. Your line is open, sir.

Thank you Ms from Ronny Gal with Bernstein. Your line is open Sir.

Ronnie Gall: Good morning, and thank you for taking my questions. I got a clarification and then a couple of questions. First, Rick, you kind of mentioned regarding Alba Tech the acceleration clauses. And I just want to clarify if this is a district court decision or appeal. Given the timing, it actually makes quite a bit of difference.

Hi, Good morning, and thank you for taking my questions I've got a clarification and then a couple of questions.

First Rick you kind of mentioned regarding alphatec about the acceleration clauses and I just wanted to clarify if this is on district court decision or our appeal given the timing it actually makes quite a bit of difference there.

Ronnie Gall: Then the two questions I have first are interchangeability for Humara. Do you think this will matter in the marketplace? We are hearing different things from the large payers. What is your take here and what is AbbVie's position on this? And the second question is that the last draft we've seen from D.C. regarding the infrastructure bill does not include a reduction of out-of-pocket costs in Medicare.

The two questions I have first our interchange ability for Humira do you think this will matter in the marketplace. We are hearing different things from the large payers.

What is your take here and what it's been like Abbvie position about that and the second question is the loss of dress, we've seen from D. C regarding the.

The infrastructure Bill does not include a reduction of out of pocket costs in Medicare we're still hearing from context still might be the case that it's still included if you can comment on this issue do you expect it to be included and the impact it might have on average business.

Ronnie Gall: We're still hearing from context that this might still be the case that it's still included. If you can comment on this issue, do you expect it to be included and the impact it might have on AbbVie? So, Ronnie, this is Rick.

Okay.

So Ronny this is Rick.

Ronnie Gall: On Alistec, obviously, these agreements that we have with the other biosimilar players are confidential, so I'm not going to delve into some of the specifics around those. But what I would tell you is what I said before. I mean, we are highly confident in our position with this IP. This IP has been challenged multiple times, and we have a high degree of confidence that we will prevail. So I think it's. It's obviously a hypothetical scenario, but I wouldn't give it a lot of merit.

Obviously these agreements that we have with the other biosimilar players are confidential, so I'm not going to I'm not going to delve into some of the specifics around those what I would tell you is what I've said before I mean, we are highly confident in our position with this IP. This IPO been challenged multiple times.

And.

We have a high degree of confidence that we will prevail.

So I think it's it's obviously a hypothetical scenario.

But I don't.

Wouldn't give it a lot of merit.

Rick Gonzalez: Second, on interchangeable humeras, as we discussed previously, when we built the erosion model that we described a couple of years ago, or certainly a year and a half or so ago, we did assume at that point that there were going to be two interchangeable biosimilars. It does matter from a pricing standpoint to some extent, so I think it will have an impact, and it's consistent with what we had assumed. And so, you know, we've essentially taken that into consideration in the forecast that we've provided you and the estimates that we've provided on drug pricing in the U.S. Look, I would say it's a very fluid situation.

Second one interchangeable humira is as we've discussed previously.

When we built the erosion model that we described a couple of years ago, or certainly a year and a half or so ago.

We did assume at that point that they were going to be two interchangeable biosimilars.

It does matter from a pricing standpoint to some extent so I think it will have an impact, but it's consistent with what we had assumed.

And so we've essentially taken that into consideration in the forecast that we provided you in the estimates that we provided you.

On.

On drug pricing in the U S.

Look I would say, it's a very fluid situation, it's a little difficult to do.

Rick Gonzalez: It's a little difficult to truly understand exactly where we are. You are correct. If you look at this framework that came out yesterday, you know, it essentially talked about repealing the rebate rule being eliminated. And it didn't talk about much else.

To truly understand exactly where we are.

You are correct. If you look at this framework that came out yesterday.

Essentially talked about repeal of the rebate.

Rule.

Being eliminated.

And it didn't talk about much else.

Rick Gonzalez: So, look, the things that we're focused on and things that we think would make a difference are out-of-pocket costs for patients and making them lower for Medicare patients, making them something that they can spread over a period of time, a 12-month period of time, to make the cash flow easier to deal with. And as we said before, we think the industry could play a role in that as one of the participants. And we would hope that we will get back to that because I think we think that is the most fundamental issue, reducing the out-of-pocket cost for patients.

So.

The things that we're focused on and things that we think would make a difference our out of pocket cost for patients.

And.

Making them lower for Medicare patients, making them something that they can spread over a period of time 12 months period of time to make their cash flow.

To deal with.

And as we've said before we think industry could play a role in that.

As one of the participants and we would hope that we will get back to that because I think we think that is the most fundamental issue is reducing the out of pocket cost for these patients.

Ronnie: Thank you, Ronnie. Operator, next question, please. Thank you. Our next question is from Geoff Meacham with Bank of America. Your line is open, sir.

Thank you Ronny operator next question please.

Thank you. Our next question is from Geoff Meacham with Bank of America. Your line is open Sir.

Geoff Meacham: Great, hey guys, thanks so much for the questions. I just have two quick ones, probably for Mike. The follow-up to RINVOC, I know it's been asked a lot, but you have a number of labeling scenarios that could play out just with respect to dose or TNF requirement or language on the black box or any limit on duration. Is there one of those items that has more of an impact than the others?

Great Hey, guys. Thanks, so much for the question.

Just have two quick ones probably for Mike.

The follow up on <unk> I know, it's been asked a lot, but you have a number of labeling scenarios that could play out just with respect to dose or TNF requirement or language on black box or any maybe any limit on duration is there one of those items that has more of an impact.

Geoff Meacham: I'm just trying to think about what informs your assessment. And the second question on cystic fibrosis, when you look at the upcoming proof of concept data readout, is there a minimal effect size or sort of profile that you're looking for that would justify moving to a larger scale phase three? Thanks.

The others I'm, just trying to think about what informs your assumptions.

And the second question on cystic fibrosis, when you look to the upcoming.

Proof of concept data readout is there a minimal effect size or sort of profile that youre looking for that would justify moving to a larger scale phase III. Thanks, so much.

Mike: So I'll take the RINVOQ question first and then make some comments on CF. You know, what I would say about RINVOQ is, you know, our assumptions around the labeling at a base case are based on what the agency announced in their safety communication in September. So that's principally updates to the black box warnings that all of these agents have.

So I'll take the RIN vote question first and then make some comments on CF, what I would say about revoke.

Is our.

<unk> around the labeling at a base case are based on what the agency announced in their safety communication in September so that's principally updates.

To the black box.

Warnings that all of these agents have and in fact.

Mike: And in fact, all agents in immunology have some degree of this that treats similar conditions to RINVO, have some of the same, but not all of the same. So, updating that section of the label is part of our base case, and then the restriction that the agency described for certain patients around TNF and adequate response forms our base case, and those are the two factors that we're considering. You know, we would not anticipate any limit in duration of therapy, for example, and, you know, the question of dose principally applies to the atopic dermatitis file because we have just a single dose in the other files, in the files that are in the rheumatology space, and we feel confident about both doses in terms of the benefit risk that we've demonstrated in that atopic dermatitis program.

All agents in immunology have some degree of this that treats similar conditions to Rainbow for example, the TNF some of the same but not all of the same warnings so updating.

That that section of the label as part of our base case and then the restriction.

The agency described for certain patients.

Around TNF inadequate response forms our base case and those are the two factors that we're considering.

We would not anticipate any limit in duration of therapy for example.

And the question dose principally applies.

Applies to the atopic dermatitis filed because we have just a single dose in the other files in the files.

That are in the rheumatology space and we feel confident about both doses in terms of the benefit risk that we've demonstrated in that <unk> atopic dermatitis program. So it's really those two dimensions.

Mike: So, it's really those two dimensions and how those translate into specific language in RA, and then, of course, how they translate to other indications. Because TNFs are not the standard of care in all indications. They're not used in atopic dermatitis, for example.

And how those translate into specific language in our raw and then of course, how they translate to the other indications because tnf's or notwithstanding of care and all indications are not used in atopic dermatitis. So then it's how do those concepts get get.

Mike: So, then it's, you know, how do those concepts get translated into the label in other indications. Those are the principal dimensions that we're looking at when we think about those programs, and again, we feel very confident in the dossiers that we've put forward and feel very good about how discussions have gone so far. With respect to CF and what we're looking for, we're looking for something that has demonstrated, you know, benefit compared to what's already out there or what will be out there at the time our agents come to market. Obviously, the principal competitor, the only group with a marketed product right now in this space, is Vertex.

Translated into the label in other indications those are the principal dimensions that we're looking at when we think about.

About those programs and again, we feel very confident in the files that we've put forward and feel very good about.

How discussions have gone to date.

With respect to CF and what we're looking for we're looking for something that has.

Demonstrated.

Benefit compared to.

<unk>.

What's already out there or what will be out there at the time of our agents come to market, obviously, the principal competitor the only.

Group with a marketed product <unk>.

Right now in this space is for tax and so that's what we would be benchmark ourselves against.

I would say and at an absolute minimum you'd have to have efficacy that was just as good with other meaningful advantages, but what we're striving for is something that has an efficacy advantage.

Mike: And so that's what we would be benchmarking ourselves against. I would say, at an absolute minimum, you'd have to have efficacy that was just as good with other meaningful advantages. But what we're striving for is something that has an efficacy advantage of a small number of absolute FEB1 points. A small number of absolute FEB1 points might not sound like much, but it can translate into real benefit for patients in this disease.

A small number of absolute.

F&B one points.

A small number of absolute FCB wants might not sound like much but it can translate into real benefit for patients in this disease.

Thank you Jeff Operator next question please.

Thank you. Our next question is from Luisa Hector with Brian Burke. Your line is open ma'am.

Thank you good morning, Im sorry, yes, I still have a couple more on wind.

I just wanted to understand whether the <unk>.

Enable update.

Hey.

And then the approvals and the new indications.

Oh, what happened on the same day or it.

Geoff: Thank you, Geoff. Operator, next question, please. Thank you. Our next question is from Luisa Hector with Barenburg. Your line is open, ma'am.

Jason I can be R&D update.

That's still a bit more what <unk> done for the new indications.

And then looking on to the <unk>.

Hi alone.

Subsequent to that filing.

In any way dependent on the.

Label thing results Oh, Yeah, that's free to be exactly this asylum Walgreens.

Late last time.

Mike: This is Mike. I'll take those two questions. So with respect to the ongoing reviews, what I would say is the discussions around the RA label update and the new indications that are under review are going on simultaneously, and there is some level of interdependence. In other words, we need to understand where the RA label will land because some of those elements, like the warnings and precautions, will translate over to the other indications because in the U.S., you get one label for the molecule. That applies across all of the indications, so there's some interdependency.

This is Mike I'll take those two questions so with respect.

To the ongoing reviews.

What I would say is the discussions around the <unk> label update and the new indications that are under review are going on simultaneously.

And.

There is some level of interdependence in other words, we need to understand where the <unk> label will land because some of those elements like the warnings and precautions will translate over to the other indications because in the U S. You get one label for the molecule.

That applies across all of the indications.

So theres some interdependency.

Mike: That's why getting the RA label update resolved is a gating factor. Whether it could happen on the same day or in close succession, I think it's too early to call at that fine level of detail, but we would expect the psoriatic arthritis and atopic dermatitis filings to follow in a very reasonable timeframe after that label update. As I mentioned, we're adding new data to the ankylosing spondylitis submission, which is the smallest of the three indications. And so that one might be on a slightly different timeframe as the agency reviews those new data.

Thats why getting the <unk> label.

Label update resolved is a gating factor whether it could happen on the same day or in close succession I think it's too early to call what that find level of detail, but we would expect.

The psoriatic arthritis, and atopic dermatitis filings to do follow in a very reasonable timeframe. After that label update as I mentioned, we are adding new data to the ankylosing spondylitis submission, which is the smallest of the three indications and so that one might.

Might be honest slightly different timeframe as the agency reviews, those new data with respect to the USEC filing we are a label update is not on critical path to file acceptance what what the agency looks at when they look at final acceptance is have you provided sufficient data for them to evaluate the file is it in an appropriate format that they can review.

Mike: With respect to the UC filing, the RA label update is not on the critical path to file acceptance. What the agency looks at when they look at file acceptance is whether you have provided sufficient data for them to evaluate the file. Is it in an appropriate format that they can review? Are there any significant deficiencies? And of course, we're very confident in the file that we've submitted, so we would not, in any way, anticipate any challenges there. And the RA safety label update is not a gating factor for file acceptance.

Are there any significant deficiencies and of course, we're very confident in.

In the file that we've submitted so we would not in any way anticipate any challenges there and the already safety label update is not a gating factor for that.

<unk> acceptance.

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

Thank you Luisa operator next question please.

Christopher Joseph Raymond: Thank you. Our next question is from Chris Raymond with Piper Sandler. Your line is open. Hi, good morning. This is Allie Bratzelon for Chris.

Thank you. Our next question is from Chris Raymond with Piper Sandler Your line is open.

Hi, Good morning. This is Alex <unk> on for Chris Thanks for taking the question.

Christopher Joseph Raymond: Thanks for taking the question. So on ABBV 951 in Parkinson's, we're just hoping you could put some of the safety findings from the phase three trial in context, particularly the imbalance in hallucinations and psychosis and the 22%, I think, treatment discontinuation rate. Basically, just how did that safety profile stack up against your expectations? And how could this translate into real-world use of 951? Thanks.

No.

The 95, one in Parkinson's.

We're just hoping you could put some of those safety findings from the phase III trial in context.

Particularly the imbalanced and hallucination psychosis.

22% I think treatment discontinuation rate.

Basically just how did that safety profile stack up against your expectations.

How does this translate into real world use of mine Taiwan. Thanks.

Mike: So this is Mike. I'll take that question. With respect to the data for 951, we're very pleased with the data. There is very strong efficacy, and the safety is within our expectations. It matches our expectations across essentially all important areas.

So this is Mike I'll take that question with respect to the data for 95 one.

Pleased with the data Theres very strong efficacy and the safety is within our expectations. It matches, our expectations across essentially all important areas.

Mike: What's important to keep in mind is this agent delivers transformative benefit to patients who have extremely difficult to control Parkinson's disease through other measures and who have a very, very difficult time controlling their disease, for example, with orals or with other approaches. And so the overall picture has to be looked at in that context. With respect to treatment discontinuations, what I would say is the treatment discontinuations, you know, the rate of that overall is very similar to what you see with similar devices, with insulin pump-like devices used across a range of conditions.

What's important to keep in mind is this agent.

It delivers transformative benefit to patients who have extremely difficult to control Parkinson's disease.

Through through other measures and to have a very very difficult time controlling their disease for example, with oracles or with other approaches and so the overall picture has to be looked at in that context with respect to treatment discontinuation, what I would say is the treatment discontinuation.

The rate of that overall is very similar to what you see with similar devices with insulin pump like devices used across a range of conditions. Most of these were driven by either.

Mike: Most of these were driven by either local tolerability issues like injection site reactions, which were principally erythema, or technical usability issues because, you know, these are older patient populations with limited mobility and dexterity in many cases. And, you know, there's always a subset of patients who find that they have difficulty using any device under those circumstances.

Local tolerability issues like injection site reactions, which were principally erythema.

<unk> technical usability issues because these are older patient populations with limited mobility and dexterity in many cases, and there's always a subset of patients who find that they have difficulty using any device under those circumstances, but again those rates of discontinuation of <unk>.

Mike: But again, those rates of discontinuation are very similar to what you see with similar insulin pump-like devices. And keep in mind, this is a very, very large population, this advanced Parkinson's population, only a very small proportion of which currently get advanced treatments because it's so limited in how they can be delivered. We think there's a big opportunity here and that the treatment discontinuation rate doesn't change that and is in line with our expectation.

Similar to what you see.

With with similar insulin pump like devices and keep in mind. This is a very very large population. This advanced Parkinson's population only a very small proportion of which currently get advanced treatments because it is so limited in how they can be delivered we think theres a big opportunity here.

And that treatment discontinuation rate doesn't change than it is in line with our expectations.

Mike: With respect to hallucinations, we know that that is on mechanism involving levofopa and carbidopa, and it's essentially evidence that we are delivering levofopa and carbidopa in a way that's more effective than can be done through other methods. And it's something that can be titrated and something that can be managed. And what I would point out is in the other direction, the oral group, the control group that got oral Levodopa and Carbidopa had more falls, which to our eye shows a lower degree of control, which matches the clinical efficacy data because we know falls are common in Parkinson's disease patients.

With respect to hallucinations.

No that that has on mechanism.

Levodopa and carbon delta and its essentially evidenced that we are delivering levodopa and carbon delta in a way and it's more effective than <unk>.

Can be done through other methods and it's something that can be titrated and something that can be managed and what I would point to is in the other direction. The oral group the control group that got oral levodopa and carbon Delta had more falls.

And that.

Two our eye shows.

A lower degree of control, which matches the clinical efficacy data because we know falls are common.

In Parkinson's disease patients, so we need to keep that in mind and with the efficacy that we've delivered we think these are all.

Mike: So we need to keep that in mind. And with the efficacy that we've delivered, we think these are all, you know, the Gastric Tube. It's actually threaded into the small bowel to get deep brain stimulation and other types of measures. So this is a much less invasive approach that delivers very strong efficacy, and we think that will translate very, very effectively into the real world.

Very attractive profiles and ones that will translate into significant real world use when we look at how this will impact your old use again and keep in mind that that it's a very broad population only a very small segment of which can access kind of therapies that they that they need to control their disease therapies like <unk>, which.

As transformative, but takes us surgical gastric tubes actually threaded into the small doll to get deep brain stimulation and other types of measures. So this is a much less invasive.

Ali: Thanks, Ali. Operator, we have time for one final question. That will come from Josh Schumer with Evercore ISI. Your line is open, sir.

Approach that delivers very strong efficacy and we think that will translate very very effectively enter into the real world.

Operator: Alright, thanks for squeezing me in. Can you talk about the current contracting season with payers for Humira and whether you think you'll be able to lock in multi-year contracts either now to extend to 2023 or next year to extend to 2024? And then I'm surprised you're not more bullish with your guidance for the migraine franchise given the strong trajectory it's on already. Any reason to think there's going to be a significant plateau in the years ahead? Thank you. Yeah, hi, it's it's Jeff.

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

That will come from Josh humor, with Evercore Evercore ISI. Your line is open Sir.

Alright. Thanks for squeezing me in can you talk about the current contracting season with payers for Humira and whether you think you'll be able to lock in multiyear contracts either now to extend it to 2023 or next year to extend to 2024.

I'm surprised you're not more bullish with your guidance for the for the migraine franchise, given the strong trajectory of tomo ready.

Recently, I think theres going to be a significant plateau in the years ahead. Thank you.

Yeah, Hi, it's Jeff so typically.

Jeff: So typically, you know, when we start to negotiate with the payers in the spring of the year for the following year, and typically, those contracts can be multi-year contracts, maybe, you know, two-year contracts. So really, that's sort of the season where, as Rob and Rick said, we'll probably have some more guidance over how things are shaping up for 23, and possibly 24, depending on the posture of the payers and how those things work out. So we're not quite there yet.

When we start to negotiate with the payers in the spring of the year for the following year.

And typically those contracts can be multi year contracts maybe.

Two year contracts, so really that's sort of the season, where we will have as Rob and Rick said, we will have probably some more guidance over how things are shaping up for 'twenty, three and possibly 24, depending on the posture of the payers and how those things work out so we're not quite there yet.

Jeff: You know, I think that what I can say is we're quite confident based on the timing that I described in terms of general cycles, in terms of where we're going to be for our portfolio, certainly in 22. In terms of QLIPDA, look, we are off to a very good start; I can, I can, I can tell you that Ubrelvi continues to run apace, and the total oral CGRP market is upwards of maybe 18% of new prescriptions, and it's still early. And that that would be us and NURTEC in the acute segment. And at a theoretical peak level, you could see, you know, maybe 30 or 40%, based on cardiovascular issues with tryptams or some other issues.

I think that what I can say is we're quite confident based on the timing that I described in terms of general cycles in terms of where we're going to be for our portfolio certainly in 'twenty two.

In terms of <unk>.

Look we are off to a very good start I can I can I can tell you that <unk> continues to run a pace that total oral <unk> market is upwards of maybe 18% of new prescriptions and it's still early in that that would be us and <unk> in the acute segment and at a theoretical peak level you.

Could see maybe 30 or 40% based on cardiovascular issues with triptans or some other issue. So we still have clear clearly some runway to go.

Jeff: So we still have clear, clearly some runway to go. It's probably a little early to sort of determine how that preventative segment will really grow, because you've only seen the MABs so far. They certainly tripled the market size. You know, how will both of these orals and, particularly, an oral like QLIPDA, in terms of market development, run apace? It's, it's encouraging, for sure, particularly if you have all three of these agents in the market and the investment behind them. Right now, though, we feel quite comfortable with the billion dollar opportunity for both of the orals.

It's probably a little early to sort of determine how that preventative segment will really grow because you've only seen really the maps. So far they certainly tripled the market size, how will both of these oracle's and particularly in oral like you lift in terms of the market development run at pace.

It's encouraging for sure, particularly if you have all three of these.

Three of these agents in the market and the investment behind it right now, though we feel quite comfortable with the with the $1 billion opportunity for both of the oral <unk>.

Josh: Thanks, Josh. And that concludes today's conference call. If you would like to listen to a replay of the call, please visit our website at investors.abbvie.com. Thanks again for joining us.

Thanks, Josh and that concludes today's conference call. If you would like to listen to a replay of the call. Please visit our website at investors that Abbvie dot com. Thanks again for joining us.

This does conclude today's conference call. We thank you all for participating. You may now disconnect and have a great rest of your day.

Okay.

This does conclude today's conference call. We thank you all for participating you may now disconnect and have a great rest of your day.