Q1 2022 Abbvie Inc Earnings Call

Good morning, and thank you for standing by.

Good morning, and thank you for standing by and welcome to the Abbvie first quarter 2022 earnings Conference call. All participants will be able to listen only until the question and answer portion of this call. You may ask a question by pressing star one on your phone today's conference is being recorded.

Welcome to the AbbVie first quarter 2022 earnings conference call.

All participants will be able to listen only until the question and answer portion of this call.

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

Today's conference is being recorded.

If you have any objections, you may disconnect at this time.

I would now like to introduce Ms. Liz Shea, Vice President, Head of Investor Relations.

If you have any objections you may disconnect at this time I would now like to introduce MS. Liz Shea Vice President head of Investor Relations.

Good morning, and thanks for joining US also on the call with me today are Rick <unk> Chairman of the Board and Chief Executive Officer, Rob, Michael Vice Chairman financing commercial operations, and Chief Financial Officer, Jeff Stuart Executive Vice President Chief Commercial Officer, and Tom Hudson Senior Vice President R&D and.

Chief Scientific officer.

Joining us for the Q&A portion of the call are Carrie Strom Senior Vice President and President Global get global Allergan aesthetic Neil.

Neil Gallagher, Vice President and Chief Medical Officer, and Ruble Tucker Vice President Global regulatory Affairs.

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 statements. Additional information about these risks and uncertainties is included in our SEC filings.

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 $19 95, 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.

AbbVie undertakes no obligation to update these forward-looking statements except as required by law.

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

On today's conference call, non-GAAP financial measures will be used to help investors understand AbbVie's business performance.

Thank you Liz good morning, everyone and thank you for joining us today I'll.

I'll briefly comment on our overall performance then Jeff Tom and Rob will review, our first quarter business highlights.

Progress and financial results in more detail.

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 their website.

I'm pleased with the excellent start to 2022.

Further reinforces our confidence in the long term fundamentals of the business.

We reported adjusted earnings per share of $3 16.

Exceeding our expectations.

Total net revenue of more than $13 $5 billion was up five 4% on an operational basis also above our expectations.

These results demonstrate strong momentum across several key products and portfolio <unk>.

Including robust double digit operational revenue growth from Sky, Rajiv Rainbow neuroscience and aesthetics.

<unk> is performing exceptionally well, we are achieving impressive market share gains in psoriasis, which remains a significant market opportunity.

<unk> recent launch in Psoriatic arthritis, as well as the anticipated regulatory approval in Crohn's disease should also serve as important growth drivers over the long term.

Greenville is also contributing compelling sales growth for <unk>.

<unk> trends have recently stabilized as we expected and we were making excellent progress repositioning the brand.

The leading second line agent based on the robust data generated across our broad development program.

Following our prepared remarks, we'll take your questions.

The early launch trends for Rainbow in both atopic dermatitis and Psoriatic arthritis are highly encouraging.

So, with that, I'll now turn the call over to Rick.

With commercial access and paid prescriptions expected to ramp significantly over the coming months.

We anticipate that these two new indications along with the recent U S approval and ulcerative colitis.

To add substantial revenue growth for Rainbow over the long term.

Neuroscience remains an exciting opportunity for our company.

<unk> continues to have strong momentum across our currently approved indications and the pending regulatory approval and major depressive disorder represents a significant upside to current projections.

In migraine or portfolio of distinct therapies with <unk>, <unk> and botox therapeutic is demonstrating robust double digit sales growth.

With the migraine market anticipated roughly double in size over the next several years. There is significant headroom for continued revenue growth with these compelling therapy.

Our steady is once again exceeding expectations. The category continues to grow robust double digits, especially in toxins and filler where there is substantial opportunity for further market penetration.

Our commercial team is executing at a high level with targeted promotion and enhanced digital services, including our Alley loyalty program driving strong market share performance across our major brands.

Thank you, Liz.

In summary.

This is an exciting time for Abbvie and I'm extremely pleased with the evolution and momentum of our diverse portfolio.

Good morning, everyone, and thank you for joining us today.

I'll briefly comment on our overall performance, then Jeff, Tom, and Rob will review our first quarter business highlights, pipeline progress, and financial results in more detail.

We're making excellent progress with the launches of several new products and indications, which will collectively add meaningful revenue for abbvie as commercial access ramps for each of these opportunities over the remainder of this year.

I'm pleased with the excellent start to 2022.

We're off to another exceptional start and our long term growth prospects remain strong.

It further reinforces our confidence in the long-term fundamentals of the business.

I'd now like to take a brief moment to.

Mike Severino, Bruce contributions to the success of Abbvie over the last eight years.

As you know Mike has decided to leave Abbvie at the end of May to pursue another career opportunity and we wish him all the best.

I'd also like to take this opportunity to formally introduce to you Tom Hudson.

I am joined Abbvie back in 2016, as the head of discovery and early development.

In 2018, Tom undertook responsibilities for Abbvie as entire discovery organization.

In 2019 was promoted to the head of Abbvie, R&D and Chief Scientific Officer, where he assumed responsibility for all of <unk> R&D.

Tom has an impressive background as a clinical scientists mehdi.

Medical specialties in clinical immunology and allergy.

Tom played a critical role in the human genome project, while working at both the Whitehead Institute and M. I T, where Tom led the team that map the human genome.

Tom was also instrumental in the international Hapmap project.

<unk> the genetic architecture of the human genome.

Tom went on to further lead the Ontario Institute for cancer Research.

Which included discovery and translational cancer research with a clinical network of more than 1000 investigators.

Tom will be providing an update on our continued pipeline progress to you later in the call, but first I'll turn the call over to Jeff for additional comments on our commercial highlights yep.

Thank you Rick we continue to demonstrate strong commercial execution across our therapeutic portfolio.

We reported adjusted earnings per share of $3.16, exceeding our expectations. Total net revenue of more than $13.5 billion was up 5.4 percent on an operational basis, also above our expectations. These results demonstrate strong momentum across several key products and portfolios, including robust double-digit operational revenue growth from Skyrizzy, Renvoke, Neuroscience, and Aesthetics.

I'll start with immunology, which delivered global revenues of more than $6 1 billion, reflecting growth of eight 1% on an operational basis.

Humira global sales were approximately $4 7 billion down one 8% on an operational basis with low single digit revenue growth in the U S.

Offset by Biosimilar competition across international markets, where revenues were down 17, 9% operationally.

Skyrizzy is performing exceptionally well.

<unk> global revenues were $940 million, reflecting positive momentum in both approved indications.

We are achieving impressive market share gains in psoriasis, which remains a significant market opportunity.

In psoriasis <unk> is demonstrating impressive market share gains globally now.

<unk> now accounts for approximately 23% of the total prescription share in the U S biologic market.

<unk> in play psoriasis share, which includes both new and switching patients also remains very very strong and now reflects roughly 40% patient share in the U S and a clear number one leadership position.

<unk> is performing exceptionally well internationally, where we have now achieved approximately 10% psoriasis share across our top 12 markets as well as in play share leadership and more than 20 key countries.

Skyrizzy's recent launch in psoriatic arthritis, as well as the anticipated regulatory approval in Crohn's disease, should also serve as important growth drivers over the long term.

While we were early in our launch and Psoriatic arthritis, we are encouraged by the uptake in this indication in the dermatology segment <unk> has already achieved in play patient share of more than 10% in the U S.

Internationally <unk> is now approved in 45 countries with reimbursement expected to increase throughout the year.

Importantly, we are also preparing for the launch of <unk> in Crohn's disease, which which represents another important long term growth driver with approval decisions anticipated this year.

Renvoke is also contributing compelling sales growth.

Turning now to <unk>, which delivered global sales of $465 million demonstrating continued strong growth as anticipated we have seen an impact to new patient starts following the label update and RIN book prescriptions have now stabilized in the U S with in play market share currently 12%.

Prescription trends in RA have recently stabilized, as we expected, and we are making excellent progress repositioning the brand as the leading second-line agent based on the robust data generated across our broad development program.

In our AG.

We expect growth in the second line plus our <unk> setting going forward, where our field force is now focused on leveraging compelling data from two important phase III trials first select choice, which demonstrated <unk> superiority versus <unk> across key efficacy parameters, including clinical remission in previous.

<unk> treated patients.

And second the open label extension of select compare which demonstrated that many patients with an inadequate response to humira are able to achieve remission after switching to rent growth.

Early feedback suggests this updated revoke our messaging is resonating very well with healthcare practitioners.

Internationally <unk> share continues to ramp and our array with a total market share of approximately five 5% across key geography.

The early launch trends for RINVOC in both atopic dermatitis and psoriatic arthritis are, highly encouraging, with commercial access and paid prescriptions expected to ramp significantly over the coming months.

We are also making excellent progress with <unk> newly launched indications, including atopic dermatitis, psoriatic arthritis, and ulcerative colitis.

We anticipate that these two new indications, along with the recent U.S. approval in ulcerative, colitis, should add substantial revenue growth for RINVOC over the long term.

Managed care access is expected to ramp strongly for each of these indications over the coming months as we build access initial prescriptions are covered by our bridge program, which provides three patients are free goods to patients until formulary coverage is established as a reminder, the volume from our bridge program is not captured.

Third party prescription data.

I'll start with atopic dermatitis, we are seeing new patient starts accelerating as we build access when.

When you include prescriptions from our bridge program <unk> total in play a D share is already in the mid teens. So we are pleased with the early adoption and repeating prescribed per <unk>.

Scriber.

As an oral option that provides significant skin clearance in itch relief. We believe were invoke has a strong differentiated position in this highly underpenetrated market.

And PSA we are seeing a nice uptake in <unk> in play share, especially in the room segment, where the severity of joint our skin manifestations of the disease and very significantly by patient.

And importantly, we have also launched <unk> in the room PSA segment this quarter, giving us two very compelling therapies to address the wide range of PSA patient types, regardless of how their symptoms present.

We have also launched our first indication in the IBD segment RIN Vogue for ulcerative colitis, where we are seeing a significant long term opportunity in the second line plus setting nearer.

Nearly 50% of UC patients are currently on or have used TNF therapy. So the addressable patient population is substantial.

Given the strong benefit risk in this indication we believe <unk> will be a welcome therapeutic option for UC patients and physicians.

Okay.

Turning now to hematologic oncology global revenues were more than $1 $6 billion down 6% on an operational basis.

<unk> global revenues were approximately $1 2 billion down seven 4%.

There are two factors impacting our <unk> results first we are seeing greater market share erosion and new patient starts than originally anticipated from newer therapy.

Including other PTK inhibitors, as well as our own <unk>.

Second we continue to see higher than expected COVID-19 suppression on new patient starts and CLO.

Which as a treat to progression therapy has impacted the total DTA treated patient market.

Our guidance assumes a market recovery over the course of this year, but it's too early to determine exactly how this may play out given the continued impact from recent Covid Barry.

Despite these dynamics and <unk> remains the market leading therapy for total patients across DLL and several other major blood cancers.

Based on the magnitude of clinical data and real world evidence generated from <unk>, showing sustained disease control as well as overall patient survival. We are confident it will continue to be a meaningful product for abbvie over the long term.

And <unk> is helping to offset some of the headwinds facing <unk> global sales were $473 million up 21, 1% on an operational basis.

In the U S and.

<unk> is the clear market share leader in frontline AML among patients who are ineligible for intensive induction chemotherapy and recently achieved leading new patient share in second line plus B L.

We are also seeing robust momentum internationally with strong performance across all approved indications.

Additionally, we continue to make excellent progress building out our heme <unk> portfolio with several compelling late stage assets, such as <unk> for B cell malignancies, <unk> for myelofibrosis in Adv $3 83 for multiple myeloma expected support is expected to support sustainable.

Long term growth.

Neuroscience remains an exciting opportunity for our company.

Turning now to neuroscience, where revenues were approximately $1 5 billion up more than 20% on an operational basis, including robust double digit growth from railcar Botox therapeutics and <unk>.

VALAR continues to have strong momentum across our currently approved indications, and the pending, regulatory approval in major depressive disorder represents a significant upside to current projections.

In migraine, our portfolio of distinct therapies, with Urelvi, Q-Lypta, and Botox Therapeutics, is, demonstrating robust double-digit sales growth. With the migraine market anticipated to roughly double in size over the next several years, there, is significant headroom for continued revenue growth with these compelling therapies.

Aesthetics is once again exceeding expectations.

The category continues to grow robust double-digits, especially in toxins and fillers, where there is, substantial opportunity for further market penetration.

<unk> is performing very well and continues to be the market, leading oral <unk> treatment for acute migraine with sequential demand growth observed.

Our commercial team is executing at a high level, with targeted promotion and enhanced digital, services, including our Alley Loyalty Program, driving strong market share performance across our major brands.

<unk> is also demonstrating exceptional uptake in migraine prevention.

With recent total prescriptions performing ahead of comparable branded launch at <unk>.

<unk> is now capturing nearly 25% of the new to brand share in the U S. Preventative <unk> clapped, when we consider both paid and bridge volume we expect.

Commercial access to continue to ramp strongly over the remainder of the year.

<unk> has also recently demonstrated positive results from a registration enabling study for the preventative treatment of chronic migraine, which we plan to submit to the agency for potential expanded use in the U S as well as to support regulatory applications across the international markets.

Syndication if approved will provide added differentiation for <unk> as the only oral <unk> therapy for the preventative treatment of both episodic and chronic migraine.

In our other notable therapeutics eyecare.

<unk> revenues of $771 million were down two 8% on an operational basis with recent generic competition for Restasis unfavorably impacting our result.

<unk> sales were $380 million down four 6% on an operational basis.

<unk> treated patient volumes remain depressed compared to pre COVID-19 levels.

In summary, this is an exciting time for AbbVie, and I'm extremely pleased with the evolution and, momentum of our diverse portfolio.

So overall I'm extremely pleased with our execution across the therapeutic portfolio, including the progress, we're making with recent new product launches.

We're making excellent progress with the launches of several new products and indications, which, will collectively add meaningful revenue for AbbVie as commercial access ramps for each of these opportunities over the remainder of this year.

We're off to another exceptional start, and our long-term growth prospects remain strong.

We remain on track to deliver strong revenue growth once again in 2022.

And with that I'll turn the call over to Tom for additional comments on our R&D program.

I'd now like to take a brief moment to thank Mike Severino for his contributions to the success of, AbbVie over the last eight years.

As you know, Mike has decided to leave AbbVie at the end of May to pursue another career, opportunity, and we wish him all the best.

Tom has an impressive background as a clinical scientist. His medical specialty is in clinical immunology and allergy.

Thank you Jeff.

I'd also like to take this opportunity to formally introduce to you Tom Hudson.

Tom played a critical role in the Human Genome Project while working at both the Whitehead, Institute and MIT, where Tom led the team that mapped the human genome. Tom was also instrumental in the international HapMap project to refine the genetic architecture, of the human genome.

I'll start with immunology.

Tom joined AbbVie back in 2016 as the head of discovery and early development. In 2018, Tom undertook responsibilities for AbbVie's entire discovery organization. Then in 2019, he was promoted to the head of AbbVie R&D and chief scientific officer, where, he assumed responsibility for all of AbbVie's R&D.

Tom went on to further lead the Ontario Institute for Cancer Research, which included discovery, and translational cancer research with a clinical network of more than 1,000 investigators.

Tom will be providing an update on our continued pipeline progress to you later in the call.

We recently received FDA approval for in bulk in ulcerative colitis, a disease, where there continues to be a significant unmet need for therapies that can provide high response rates and durable remission.

But first, I'll turn the call over to Jeff for additional comments or commercial highlights.

Jeff?

In our U C development program.

<unk> demonstrated some of the highest rates of remission and endoscopic improvement seen in phase III studies.

Importantly, Rainbow Corso provided durable responses.

<unk> through one year of treatment.

Given the strong benefit risk profile, we believe <unk> will be an important new medicine for patients.

Our regulatory applications for Rainbow and UC remain under review in Europe and Japan.

With approval decisions expected in the second half of this year.

Also in the area of inflammatory bowel disease, we recently reported positive top line results.

So on the second phase III industrial induction study for invoke and Crohn's disease.

Similar to results from the first induction trial in this induction study <unk> demonstrated a very strong impact on the disease.

As measured by clinical remission and endoscopic response.

We expect to see results from the phase III maintenance study later in the quarter with our regulatory submissions for invoke in Crohn's disease.

Expected into third quarter and approval decisions anticipated in 2023.

Rounding out the inbox development programs in Rheumatology, we also have regular regulatory applications under review.

<unk> spondylitis.

In non radiographic axial spa.

We expect an FDA approval decision in the second quarter for <unk>.

And decisions in the fourth quarter for non radiographic axial spa.

Thank you, Rick.

Moving to <unk>, where in the quarter, we announced an update regarding our regulatory application for Crohn's disease in the U S.

We continue to demonstrate strong commercial execution across our therapeutic portfolio.

I'll start with immunology, which delivered global revenues of more than $6.1 billion, reflecting growth of 8.1% on an operational basis.

Following an FDA request for additional information primarily related to the on body injection device used for maintenance dosing. We provided additional data for the device from an ongoing real life use study, which showed that patients can safely and effectively use the on body device to self administer.

Humeric global sales were approximately $4.7 billion, down 1.8% on an operational basis, with low single-digit revenue growth in the U.S., offset by biosimilar competition across international markets, where revenues were down 17.9% operationally.

SkyRIZI global revenues were $940 million, reflecting positive momentum in both approved, indications. In psoriasis, SkyRIZI is demonstrating impressive market share gains globally.

SkyRIZI now accounts for approximately 23% of the total prescription share in the U.S, biologic market.

SkyRIZI's in-play psoriasis share, which includes both new and switching patients, also remains, very, very strong, and now reflects roughly 40% patient share in the U.S., and a clear number one leadership position.

SkyRIZI is performing exceptionally well internationally, where we have now achieved approximately 10% psoriasis share across our top 12 markets, as well as in-play share leadership in more than 20 key countries.

While we were early in our launch in psoriatic arthritis, we are encouraged by the uptake, in this indication.

In the dermatology segment, SkyRIZI has already achieved in-play patient share of more than, 10% in the U.S.

Internationally, SkyRIZI PSA is now approved in 45 countries, with reimbursement expected, to increase throughout the year.

Importantly, we are also preparing for the launch of SkyRIZI in Crohn's disease, which, represents another important long-term growth driver, with approval decisions anticipated this year.

Turning now to RINVOC, which delivered global sales of $465 million, demonstrating continued, strong growth.

As anticipated, we have seen an impact in new patient starts following the label update, and RINVOC prescriptions have now stabilized in the U.S., with in-play market share currently, 12% in RA.

<unk>.

We expect growth in the second-line plus RA setting going forward, where our field force, is now focused on leveraging compelling data from two important phase three trials.

First, SelectChoice, which demonstrated RINVOC's superiority versus Orenthia across key efficacy, And second, the open label extension of Select Compare, which demonstrated that many RA patients with an inadequate response to Humira are able to achieve remission after switching to RINVOKE.

After responding to the agency's request.

We received a three month extension of our sky resist submission and cause disease.

We remain confident in a strong benefit risk profile for <unk> in Crohn's disease.

And we now expect a decision in June .

Moving now to oncology portfolio, where we continue to make excellent progress.

Across all stages of our heme and solid tumor pipeline.

We recently announced positive top line results.

From the first expansion cohort of the phase II study evaluating <unk> in patients with aggressive B cell lymphoma, who have received at least two prior lines of therapy.

At <unk> performed extremely well as a monotherapy in these heavily pretreated and high risk patients demonstrating an overall response rate of 63% with a median duration of response of 12 months.

These results are particularly encouraging given that nearly 40% of patients had failed car T therapy.

We plan to discuss these results with regulatory agencies about the potential to support submission for accelerated approval in the second half of this year.

We continue to make good progress with the indication expansion programs Corbin collector and remain on track to see results from the phase III Canova trial in relapsed refractory multiple myeloma patients with a T 11, and 14 mutation.

In the second half of this year.

And I think <unk> Mds program based on feedback from the FDA.

We have recently modified our regulatory strategy and now intend to submit data from our ongoing phase III program.

<unk> remains under breakthrough therapy designation for Mds.

And we continue to have a high degree of enthusiasm prevent <unk> in this indication.

We expect data readout from the phase III study and our regulatory submission for Mds.

In 2024.

Early feedback suggests this updated RINVOKE RA messaging is resonating very well with, healthcare practitioners.

In neuroscience, the FDA recently accepted our application for <unk> as an adjunctive treatment for major depressive disorder.

Internationally, RINVOKE share continues to ramp in RA, with a total market share of approximately, 5.5% across key geographies.

We are also making excellent progress with RINVOKE's newly launched indications, including, atopic dermatitis, psoriatic arthritis, and ulcerative colitis.

Managed care access is expected to ramp strongly for each of these indications over the coming, months. As we build access, initial prescriptions are covered by our bridge program, which provides, free patients or free goods to patients until formulary coverage is established. As a reminder, the volume from our bridge program is not captured in third-party prescription, data.

I'll start with atopic dermatitis.

We are seeing new patient starts accelerating as we build access.

When you include prescriptions from our bridge program, RINVOKE's total in-play AD share, is already in the mid-teens, so we are pleased with the early adoption and repeating prescribers.

Based on the strong benefit risk profile demonstrated in our clinical program. We believe <unk> will be an important new therapy in this patient population and we look forward to bringing this new treatment option to patients suffering from major depressive disorder.

As an oral option that provides significant skin clearance and itch relief, we believe, RINVOKE has a strong differentiated position in this highly underpenetrated AD market.

In PSA, we are seeing a nice uptake in RINVOKE's in-play share, especially in the room segment, where the severity of joint or skin manifestations of the disease can vary significantly by patient.

And importantly, we have also launched SCIRIZI in the room PSA segment this quarter, giving, us two very compelling therapies to address the wide range of PSA patient types, regardless of how their symptoms present.

We have also launched our first indication in the IBD segment, RINVOKE for ulcerative, colitis, where we are seeing a significant long-term opportunity in the second line plus setting. Nearly 50 percent of UCT patients are currently on or have used TNF therapy, so the addressable, patient population is substantial. Given the strong benefit-risk in this indication, we believe RINVOKE will be a welcome therapeutic, option for UCT patients and physicians.

Turning now to hematologic oncology, global revenues were more than $1.6 billion, down, 0.6 percent on an operational basis. Imbruvica global revenues were approximately $1.2 billion, down 7.4 percent. There are two factors impacting our Imbruvica results. First, we are seeing greater market share erosion in new patient starts than originally, anticipated from newer therapy, including other BTK inhibitors, as well as our own Venclexa.

Second, we continue to see higher-than-expected COVID suppression on new patient starts in, CLL, which, as a treat-to-progression therapy, has impacted the total BTK-treated patient market.

Our guidance assumes a market recovery over the course of this year, but it's too early, to determine exactly how this may play out, given the continued impact.

Impact from recent COVID variants.

Despite these dynamics, Imbruvica remains the market-leading therapy for total patients, across DLL and several other major blood cancers.

Based on the magnitude of clinical data and real-world evidence generated from Imbruvica, showing sustained disease control as well as overall patient survival, we are confident it will continue to be a meaningful product for AbbVie over the long term.

BenClexa, however, is helping to offset some of the headwinds facing Imbruvica.

Global sales were $473 million, up 21.1% on an operational basis.

In the U.S., BenClexa is the clear market share leader in frontline AML among patients, who are ineligible for intensive induction chemotherapy and recently achieved leading new patient share in second-line plus DLL.

We are also seeing robust momentum internationally, with strong performance across all approved, indications.

Additionally, we continue to make excellent progress building out our Heme Onc portfolio, with several compelling late-stage assets, such as EpiCorritamab for B-cell malignancies, Nividoclax for myelofibrosis, and ADV383 for multiple myeloma, expected to support sustainable, long-term growth.

Turning now to neuroscience, where revenues were approximately $1.5 billion, up more than, 20% on an operational basis, including robust double-digit growth from Raylar, Botox Therapeutic, and Ubrelvi. Ubrelvi is performing very well and continues to be the market-leading oral CGRP treatment, for acute migraine, with sequential demand growth observed.

In the area of migraine, we recently reported positive top line results from our phase III study evaluating <unk> alimta.

Q-Lypta is also demonstrating exceptional uptake in migraine prevention, with recent, total prescriptions performing ahead of comparable branded launches.

The prevention of chronic migraine.

Q-Lypta is now capturing nearly 25% of the new-to-brand share in the U.S. preventatives, DGRP class, when we consider both paid and bridge volume. We expect commercial access to continue to ramp strongly over the remainder of the year.

To lift up performed very well in this study with both doses meeting the primary and all secondary endpoints.

Demonstrating <unk> ability to significantly reduce migraine days.

For patients suffering from chronic migraine.

Q-Lypta has also recently demonstrated positive results from a registration-enabling study, for the preventative treatment of chronic migraine, which we plan to submit to the agency for potential expanded use in the U.S., as well as to support regulatory applications across the international markets. This indication, if approved, will provide added differentiation for Q-Lypta as the only, oral CGRP therapy for the preventative treatment of both episodic and chronic migraine.

This number.

We plan to submit our regulatory application to the FDA for <unk> in chronic migraine.

And also plan to submit data from our phase III studies in both chronic migraine and episodic migraine.

Support regulatory applications in markets outside the U S.

In our cystic fibrosis program. We recently completed an interim analysis of our phase II proof of concept study evaluating our triple combination therapy.

The results.

You can see results from this interim analysis did not meet our pre specified criteria for advancing this triple therapy in development.

The study was designed with a 28 day run in treatment period with a dual combination therapy containing our SKU, one corrector and potentiate or followed by a 28 day treatment period.

With a triple combination, which included the addition of our CTO character ABV one nine.

In our other notable therapeutics, eye care revenues of $771 million were down 2.8% on, an operational basis, with recent generic competition for Restasis unfavorably impacting our results.

Maverick sales were $380 million, down 4.6% on an operational basis, as treated patient, volumes remain suppressed compared to pre-COVID levels.

This allowed us to independently assess the therapeutic potential of our situ collector.

The results showed that the addition of 109 did not provide a meaningful improvement in F&B, one or reduction in sweat chloride concentration.

Over our dual combination therapy.

During the run in treatment period.

We were able to again assess the efficacy of our dual therapy.

Which performed well.

Providing efficacy consistent with results for the existing dual combination therapy.

So based on the performance of our dual therapy, we plan to continue our CF program.

We have an additional situ collector ABV $5 76 in phase one studies that we plan to advance into a new triple therapy with our existing tier one corrector and potentiate or.

576 is structurally distinct from our previous 60 to correct, a 109 and has a better PK profile and provides higher drug exposure.

Which has the potential to deliver a better efficacy.

Our plan is to begin a phase two study for this new triple combo by early next year.

And in aesthetics.

We began the phase III program for our short acting toxin, Inc. Live better lives.

<unk> novel toxin is designed to provide rapid onset of action and a short duration of effect.

Which would lower the barrier for adoption for certain segments of consumers.

We expect to see data from this program next year with regulatory applications also anticipated in 2023.

So overall, I'm extremely pleased with our execution across the therapeutic portfolio, including the progress we're making with recent new product launches.

So in summary.

We've continued to make significant progress with our pipeline to start the year.

And we look forward to many more data readouts regulatory submissions and approvals throughout the remainder of 2022.

We remain on track to deliver strong revenue growth once again in 2022.

With that I'll turn the call over to Rob for additional comments on our first quarter performance.

<unk> financial outlook Rob.

And with that, I'll turn the call over to Tom for additional comments on our R&D program.

Thank you Tom <unk> first quarter results demonstrate the strength of our broad portfolio, including double digit growth from Sky Rizzi, RIN Vogue in Clarksdale neuroscience and aesthetics.

Tom?

Thank you, Jeff.

We also continued to deliver strong P&L performance with another quarter of robust operating margin expansion, while fully funding the business for long term growth.

We reported adjusted earnings per share of $3 16.

Reflecting growth of nine 3% compared to prior year and <unk> <unk> above our guidance midpoint.

This includes an 8% unfavorable impact from acquired IP R&D expense that was not factored into our original guidance.

Total net revenues were more than $13 5 billion.

Up five 4% on operational basis, excluding a one 3% unfavorable impact from foreign exchange.

Net revenues came in above our guidance despite the entry of generic competition for Restasis.

The adjusted operating margin ratio was 51, 4% of sales an improvement of 150 basis points versus the prior year.

This includes adjusted gross margin of 84, 5% of sales adjusted R&D investment of 10, 9% of sales acquired IP R&D expense of one 1% of sales and adjusted SG&A expense of 21, 1% of sales.

Net interest expense was $539 million and the adjusted tax rate was 12, 1%.

Turning to our financial outlook, we are updating our full year adjusted earnings per share guidance to include the eight for acquired IP R&D expense that was incurred during the first quarter. As a result, we now expect full year adjusted earnings per share between $13 92 and $14.

<unk>.

This earnings per share guidance does not include an estimate for acquired IP R&D expense that may be incurred beyond the first quarter.

We now expect net revenues of approximately $59 4 billion at current rates, we expect foreign exchange had a one 4% unfavorable impact on full year sales growth.

This revenue guidance includes updated restasis sales of approximately $400 million.

Moving to the P&L, we now expect adjusted gross margin of 84, 5% of sales.

Adjusted SG&A expense of $12 5 billion.

And an adjusted operating margin ratio of 51, 8% of sales.

Turning to the second quarter, we anticipate net revenues of approximately $14 6 billion at current rates, we expect foreign exchange had a one 5% unfavorable impact on sales growth.

We expect adjusted earnings per share between $3 38, and $3 42.

This guidance does not include acquired IP R&D expense that may be incurred in the quarter.

I'll start with immunology.

In closing we are off to an excellent start to the year with strong performance across multiple areas, we are making significant progress with new product launches and the pipeline.

We recently received FDA approval for RINVOC and ulcerative colitis, a disease where there, continues to be a significant unmet need for therapies that can provide high response rate and durable remission. In our UC development program, RINVOC demonstrated some of the highest rates of remission and, endoscopic improvements seen in phase three studies. Importantly, RINVOC also provided durable responses sustained through one year of treatment. Given a strong benefit-risk profile, we believe RINVOC will be an important new medicine for, patients.

Our regulatory applications for RINVOC in UC remain under review in Europe and Japan, with approval decisions expected in the second half of this year. Also in the area of inflammatory bowel disease, we recently reported positive top-line results, from the second phase three induction study for RINVOC in Crohn's disease. Similar to results from the first induction trial, in this induction study, RINVOC demonstrated, a very strong impact on the disease, as measured by clinical remission and endoscopic response.

We expect to see results from the phase three maintenance study later in the quarter, with, our regulatory submissions for RINVOC in Crohn's disease expected in the third quarter and approval decisions anticipated in 2023.

<unk>, our confidence in <unk> long term growth outlook with that I'll turn the call back over to Liz.

Rounding out RINVOC's development programs in rheumatology, we also have regulatory applications, under review in ankylosing spondylitis and non-radiographic axial spas.

We expect an FDA approval decision in the second quarter for AS, and decisions in the, fourth quarter for non-radiographic axial spas.

Moving to SCIRISI, where in the quarter we announced an update regarding our regulatory, application for Crohn's disease in the U.S. Following an FDA request for additional information primarily related to the on-body injection, device used for maintenance dosing, we provided additional data for the device from an ongoing real-life use study, which showed that patients can safely and effectively use the on-body device to self-administer SCIRISI. After responding to the agency's request, we received a three-month extension of our, SCIRISI submission in Crohn's disease. We remain confident in a strong benefit-risk profile for SCIRISI in Crohn's disease, and, we now expect a decision in June.

Moving to our oncology portfolio, where we continue to make excellent progress across, all stages of our heme and solid tumor pipeline. We recently announced positive top-line results from the first expansions cohort of the Phase, II study, evaluating epiritumab in patients with aggressive B-cell lymphoma who have received at least two prior lines of therapy. F-Caritamide performed extremely well as a monotherapy in these heavily pre-treated and, high-risk patients, demonstrating an overall response rate of 63% with a median duration of response of 12 months.

These results are particularly encouraging given that nearly 40% of patients had failed, CAR-T therapy. We plan to discuss these results with regulatory agencies about the potential to support submission, for accelerated approval in the second half of this year.

We continue to make good progress with the indication expansion programs for Venclexa, and remain on track to see results from the Phase III Canova trial in relapsed refractory multiple myeloma patients with a T1114 mutation in the second half of this year.

In our Cystic Fibrosis Program, we recently completed an interim analysis of a Phase II, proof-of-concept study evaluating our triple-combination therapy. The efficacy results from this interim analysis did not meet our pre-specified criteria for, advancing this triple therapy in development. The study was designed with a 28-day run-in treatment period with a dual-combination therapy, containing our C1 corrector and potentiator, followed by a 28-day treatment period with a triple combination, which included the addition of our C2 corrector, ABBV119.

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. Please.

In our Venclexa MDS program, based on feedback from the FDA, we have recently modified our, regulatory strategy and now intend to submit data from our ongoing Phase III program.

Venclexa remains under breakthrough therapy designation for MDS, and we continue to have, a high degree of enthusiasm for Venclexa in this indication. We expect data readout from the Phase III study and our regulatory submission for MDS, in 2024.

In neuroscience, the FDA recently accepted our application for RAIL-R as an adjunctive, treatment for major depressive disorder. Based on the strong benefit-risk profile demonstrated in our clinical program, we believe RAIL-R, will be an important new therapy in this patient population, and we look forward to bringing this new treatment option to patients suffering from major depressive disorder.

In the area of migraine, we recently reported positive top-line results from a Phase III, study evaluating QLIPTA for the prevention of chronic migraine. QLIPTA performed very well in this study, with both doses meeting the primary and all, secondary endpoints, demonstrating QLIPTA's ability to significantly reduce migraine days for patients suffering from chronic migraine.

This summer, we plan to submit our regulatory application to the FDA for QLIPTA in chronic, migraine and also plan to submit data from our Phase III studies in both chronic migraine and episodic migraine to support regulatory applications in markets outside the U.S.

This allowed us to independently assess the therapeutic potential of our C2 corrector.

Thank you our first question comes from Mohit Bansal.

The results showed that the addition of 119 did not provide a meaningful improvement in, FEB1 or reduction in sweat chloride concentration over our dual combination therapy.

From Wells Fargo. Your line is now open.

During the run-in treatment period, we were able to again assess the efficacy of our dual, therapy, which performed well, providing efficacy consistent with results for the existing dual combination therapy. So based on the performance of our dual therapy, we plan to continue our CF program.

We have an additional C2 corrector, ABBV576, in Phase I studies that we plan to advance, into a new triple therapy with our existing C1 corrector and potentiator. 576 is structurally distinct from our previous C2 corrector 119 and has a better PK profile, and provides higher drug exposure, which has the potential to deliver better efficacy.

Our plan is to begin a Phase II study for this new triple combo by early next year.

And in aesthetics, we recently began the Phase III program for our short-acting toxin, in glabellar lines. This novel toxin is designed to provide rapid onset of action and a short duration of effect, which would lower the barrier for adoption for certain segments of consumers. We expect to see data from this program next year with regulatory applications also anticipated, in 2023.

Great. Thanks for taking my question.

Maybe maybe to begin with.

<unk>.

I mean, the script trends are down.

And you mentioned that you have.

Putting us Todd.

You are losing some share to the competition.

I think can you. Please characterize how much share you are losing in beauty to stabilize over time and when you look at and really kind of the nickel combined do you think the franchise can grow going forward. Thank you.

Yes. Thank you for the question so as I mentioned in my comments, we are seeing greater share erosion in <unk> continues to be the.

So in summary, we've continued to make significant progress with our pipeline to start the year, and we look forward to many more data readouts, regulatory submissions, and approvals throughout the remainder of 2022.

The leading share in the later lines, although we have lost.

Our frontline share position to calculate and obviously then <unk> also moving there. So we see a couple of things that are taking place. So we have that that share erosion, that's putting some pressure on the brand and then clearly we see the continued suppression of the market. So it's kind of like a double hit if we think of our if we.

Of this over the short mid and longer term, what I would say would be this so in the short term, meaning this year.

We projected the share decline and that includes some stabilization, but we still think the brand is under some pressure from other <unk> and Ben cluster.

And basically we have flat guidance this year and some of that includes a recovery of the market back to sort of more normal levels and we'll have to see how that progresses over the year.

I think more about the midterm I think what's important context, there is new patient starts essentially make up roughly 13% to 15% of improve outcomes. So it's got a very very large installed base about 85%, maybe a little bit more in terms of what that's going to happen.

Not seeing any changes in persistency or items like that so we think that we have.

A very good sense of stability for the brand over over time in terms of what this may mean, so that's basically how we think about it.

To answer your other question. If you look at the combined share Abbvie has a has quite a strong position we have roughly 33% of total share in the frontline and.

And we have between 42% and 46% of second line plus so clearly <unk> is able to offset as I commented in my remarks, some of those pressures. So it's very important for for Abbvie, it's going to be a very big brand over the long term in the short term here in midterm the growth is going to be more challenge.

Moving forward.

With that, I'll turn the call over to Rob for additional comments on our first quarter, performance and financial outlook.

Thank you.

Rob?

Thanks, Bill Hait operator next question please.

Thank you, Tom.

Robby's first quarter results demonstrate the strength of our broad portfolio, including, double-digit growth from Skyrizzy, Renvoke, BenClexta, Neuroscience, and Aesthetics.

We reported adjusted earnings per share of $3.16, reflecting growth of 9.3 percent compared, to prior year, and 4 cents above our guidance midpoint. This includes an 8-cent unfavorable impact from acquired IPRD expense that was not factored, into our original guidance.

We also continue to deliver strong P&L performance with another quarter of robust operating margin, expansion while fully funding the business for long-term growth.

Thank you. Our next question comes from Terence Flynn from Morgan Stanley . Your line is now open.

Hi, Thanks for taking the questions.

I was just wondering obviously you guys have been speaking with payers about the humira positioning for 2023.

Are you willing to give us any update in terms of how youre thinking about that the guidance figure that you put out a couple of years ago any change in thinking there and then.

Are you able to disclose the CR rate for the recent period, a mab phase two trial, just wondering how that factors into the decision about whether to seek accelerated approval here. Thank you.

Total net revenues were more than $13.5 billion, up 5.4 percent on an operational basis, excluding, a 1.3 percent unfavorable impact from foreign exchange.

Sure This is Rick.

Net revenues came in above our guidance, despite the entry of generic competition for, risk basis.

I'll take that.

The adjusted operating margin ratio was 51.4 percent of sales, an improvement of 150 basis, points versus the prior year.

This guidance does not include acquired IPRD expense that may be incurred in the quarter.

This includes adjusted gross margin of 84.5 percent of sales, adjusted R&D investment, of 10.9 percent of sales, acquired IPRD expense of 1.1 percent of sales, and adjusted SG&A, That interest expense was $539 million, and the adjusted tax rate was 12.1%.

In closing, we are off to an excellent start to the year with strong performance across, multiple areas.

Terence This is Rick I'll take the first question.

Turning to our financial outlook, we are updating our full-year adjusted earnings per share, guidance to include the $0.08 for acquired IPRD expense that was incurred during the first quarter. As a result, we now expect full-year adjusted earnings per share between $13.92 and $14.12.

We are making significant progress with new product launches and the pipeline, underscoring, our confidence in AVI's long-term growth outlook.

This earnings per share guidance does not include an estimate for acquired IPRD expense, that may be incurred beyond the first quarter. We now expect net revenues of approximately $59.4 billion.

At current rates, we expect foreign exchange to have a 1.4% unfavorable impact on full-year, sales growth.

For Ya.

This revenue guidance includes updated restated sales of approximately $400 million. According to the P&L, we now expect adjusted gross margin of 84.5% of sales, adjusted SG&A, expense of $12.5 billion, and an adjusted operating margin ratio of 51.8% of sales.

Turning to the second quarter, we anticipate net revenues of approximately $14.6 billion. At current rates, we expect foreign exchange to have a 1.5% unfavorable impact on sales, growth. We expect adjusted earnings per share between $3.38 and $3.42.

I'm, probably going to answer or broader because I think it is important I understand the interest in trying to understand how to model 2023, It's obviously important to us to model 2023 as accurately as possible.

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

Thanks, Rob.

And I think if you step back obviously contracting is one portion of our variable that will impact the speed at which.

Biosimilars are able to adopt be adopted in the market.

Step back and look Theres, probably four key variables that will impact what that adoption rate looks like.

One of them is obviously what will Humira is.

<unk>.

Post biosimilars entering in the marketplace.

And this is the period, where you would normally be doing the contracting around that I think will do well.

And being able to be co position versus biosimilars.

And the vast majority of.

I've covered lives here in the United States, but that process isn't done and we're not in a position to be able to ultimately give you any further update until we're a little further along in that process.

Second variable that will impact what 2023, it looks like is how will the biosimilars price. We don't know that obviously we have seen.

In markets outside the U S. But there is no market exactly like the U S.

Internationally and so that's a variable we're making some some projections of what we believe that pricing will look like but thats ultimately something we're going to have to see how it plays out.

I'd say the third variable is our competitive movies biosimilars be theres going to be by the summer of 2023, there's going to be a lot of biosimilars in the U S market, but they're not all the same and how competitive will they be against what is humira today and what are the bulk of patients to use.

As it relates to Humira and what I mean by that is interchange ability and a number of other factors are going to play into the competitiveness of those biosimilars and I would say the fourth variable and it's not something that people think about.

That much and that is the ability of a biosimilar to be able to supply the U S market Theres no market like the United States for Humira anywhere around the world United States is significantly larger than any other market around the world. There are certainly biosimilar players that are like and Abbvie.

And I would expect them to have manufacturing capacity.

And Eric players that could have sufficient manufacturing capacity and then they are a very small companies.

But I think anybody any payer or there is going to want at Pittsburgh.

Any significant way to our biosimilar, they're gonna want confidence that they can have a reliability of supply of that Biosimilar and we've spent years building. The network that we have we have full redundancy.

Every aspect of the manufacturing process on Humira.

And we've never had a problem supply in the U S market.

So I think we can be viewed as kind of the gold standards. So those are the variables that are going to impact what this with us.

Transition looks like.

The guidance, we've given so far is this 45% plus or minus 10% I think at this point that's still the best the.

The best information that we can provide.

Later this year I think some of these variables will be clearer.

And we may be in a position to be able to provide some more information to investors and we would do that some will not pricing will not be clear at that point, we're not going to know how they're going to price until we actually get into the they actually get into the marketplace. So I think that's the way to think about these variables.

Rob anything you'd add yes. So this is Rob I'll, just I would just add that we've been trying to give investors. Some directional guidance on how to think about 'twenty three beyond just the humira, 45% plus or minus 10%.

We've talked about aesthetics growing high single digits annually over the next decade, you can get a sense based on Jeff's response today in a way to think about improve our costs in terms of operating margin I've talked about pulling back to the <unk>, 46% to 47% range with no cuts investment because we are going to return to growth very quickly. So we're going continue to invest in this business and as I look at street consensus.

Modeling of cuts in SG&A.

Not necessarily reflecting the appropriate operating margin levels, that's something just to keep in mind and then even we've talked about the tax rate growing at one point per year on average obviously you saw this year. It only grow two points other years. It may go higher so we've tried to give the street some ideas of the way to think about 'twenty three model it in advance of our formal guidance.

We will now open the call for questions.

Okay remember too Neil Hi, This is Neil John here I'll take the question regarding a grid them up so we recently reported data.

Data from the from the expansion cohorts of relapsed refractory <unk> patients.

We reported an overall response rate of 63% with the median duration of response of 12 months. One thing that's really important to bear in mind is that.

Pretty refractory patient population with.

Median number of prior therapies of three five in a range of 211.

At the upper end and importantly, just under 40% of these patients have failed prior therapy with a car T. Overall, the safety profile remains manageable with the vast majority of cases of C or asset class.

A class effect with these agents being grade one and two.

To directly address your question, we are not yet ready to reveal additional detail about the data that they will be revealed.

At a forthcoming medical meeting and in fact I was just in contact with the team yesterday and I know that they are working very diligently.

To get those data on a podium.

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.

In a meeting in the very near future.

Okay. Thank you Karen operator, we'll take the next question. Please.

Operator, we'll take the first question, please.

Thank you. Our next question is from Tim Anderson from Wolfe Research. Your line is open.

Thank you.

Hello, Thanks for taking our question. This is Alex on for Tim Anderson.

Our first question comes from Mohit Bansal from Wells Fargo.

A question on <unk>.

In today's market.

Okay.

Daniel.

And are you seeing any switching away from two pits into tool.

Your line is open.

Okay.

Yes. Thank you. Thank you for the question I'll give you some some context I mentioned that we we see roughly in the mid teens now after about three months, which we're very pleased and some more flavor on that if you think about.

Great.

Thanks for taking my question.

Maybe to begin with, on Imruvika, the script rents are down.

The HCP and the doctors that prescribed in the U S. Now.

You've got about 9000 those are the those are the dermatologists and some allergists. There's about 3000 of those physicians that are the big prescribers, they're very productive. Those 3000 are the ones that are driving sky Rizzi for example, or other other big brands in psoriasis. So we see.

After just about three months, we see almost 1000 doctors that had prescribed RIN book and so that's driving that 15%.

You mentioned that for new start, you are losing some share to the competition.

Some of it depends in terms of where the in play share ends up how many of the competitors come in we're not really sure that <unk> will come into the market.

We'll have to see we havent seen much Pfizer activity, yet to give you some sort of international perspective.

Can you please characterize how much share you are losing and do you think it will stabilize, over time?

When you look at Imruvika and Venetoclast combined, do you think the franchise can grow going, forward from here?

In the Canadian market, we're seeing where theres really just do P and RIN book at this point after couple of quarters, we're seeing a 30% in place here in Canada.

So we are as I mentioned very very encouraged with the early adoption in particular my comment around how fast once you see the first prescription take place with some of those productive doctors how fast they go to the second or third.

To give you some flavor of what we see in the U S and again the data is early we see as expected the majority of of our used so far in that dynamic market or are not not not switches necessarily we see about let's say a third believe it or not that are not even.

To dupee and the doctors are saying look I've already given another oral systemic for example.

But the itch and the and the skin is so severe that theyre going to go I'm going to go right and get the relief with Rainbow and then maybe the other two thirds you see dupee partial responders, particularly related to the <unk> just isn't suppressed as much and they still have some skin involvement or.

There is as we've highlighted before a warehouse of dupee non responders that has been built up over the last four years. So that's the behavior that we see again I'm very encouraged on the early results not just in the U S. But around the world <unk> is going to be a real player in this underserved market.

Thank you.

Yeah.

Thank you Alex Operator next question please.

Thank you for the question.

So, as I mentioned in my comments, we are seeing greater share erosion.

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

Imruvika continues to be the leading share in the later lines, although we have lost, our front-line share position to Kalkwins, and, obviously, then Klexta is also moving there. So, we see a couple things that are taking place.

Thank you two questions first on <unk> the data looks great.

So, we have that share erosion that's putting some pressure on the brand, and then, clearly, we see the continued suppression of the market. So, it's kind of like a double-hit.

This molecule immediately start taking share from car T or do you think physicians will want to see durability data before selecting a bi specific ahead of a cell therapy. So that's the first question. The second question is I'm trying to sift through the answer to the Humira question in just a moment ago.

If we think of this over the short, mid, and longer term, what I would say would be this.

So, in the short term, meaning this year, we projected the share decline, and that includes, some stabilization, but we still think the brand is under some pressure from other BTKs and then Klexta.

And basically, we have flat guidance this year, and some of that includes a recovery, of the market back to sort of more normal levels.

And we'll have to see how that progresses over the year.

If I think more about the midterm, I think what's important context there is new patient, starts essentially make up roughly 13 to 15% of Imbruvita.

So it's got a very, very large installed base, about 85%, maybe a little bit more in terms, of what that's going to happen.

We're not seeing any changes in persistency or items like that, so we think that we have, you know, a very good sense of stability for the brand over time in terms of what this may mean.

On the one hand, it seems we need to consider that humira could be more resilient in 2023 than expected.

On the other hand, the street needs to raise spending assumptions. So would you object to either of those conclusions based on what was stated thank you.

So that's basically how we think about it.

Thanks.

To answer your other question, if you look at the combined share, AbbVie has quite a, strong position.

Steve This is Neil I'll take the first question on that grid them out.

We have roughly 33% of total share in the front line, and we have between 42% and 46% of second line plus.

So clearly, then Clexa is able to offset, as I commented in my remarks, some of those, pressures.

So it's very important for AbbVie.

Thank you.

It's going to be a very big brand over the long term.

The fact that we saw such remarkable.

In the short term here in midterm, the growth is going to be more challenged moving forward.

<unk> in a patient population that had failed car T does not imply that the medicine should be positioned after failure of car T. I think there are two very different classes of <unk>.

Medicines as you know.

Car T has significant challenges with respect to the need for.

The merits of it prior.

Prior to administration.

The safety profile with <unk> is extremely manageable.

And again I don't want to repeat what I said earlier on around Crs, but overall, we see a very.

Strong benefit risk profile emerging for the medicine, and therefore, our intention is to move the medicine into earlier lines of therapy and SD gain an approval.

With respect to gain approval in <unk> refractory <unk>.

And after that move be moved to medicine into earlier lines of therapy.

Thanks, Mohit.

Steve This is Rick I think Robyn I'll handle the second question for you.

Yes look I think it's a great question and we've gotten that question a lot. What's the Roes are going to be in 'twenty, three and is it going to be lighter in 'twenty, three and therefore fell more than the 24 and I think that's a reasonable question too.

To start to think through.

I'd say as I step back and look at it I would tell you. The best look at the end of the day it could be later in 'twenty three.

That would force more of it out into 'twenty four.

I look at the business. That's a good thing and will give us higher cash flows in 'twenty three than what we would be projecting now.

Ultimately I think there will be a settling out between 23 and 24, we will still get to the levels that we have we.

We have described or at least that we're modeling.

And I think the important thing is like Humira is going to play out over these two two year period of time, what's important to Abbvie, though is what's that underlying growth is.

Driving the business and it is going to sustain the growth on the other side of the yellow that's the critical aspect of it.

<unk> the RIN votes, our neuroscience pipeline is Fedex, it's all of those major growth drivers that we have because that growth.

Is going to be suppressed in 'twenty three 'twenty four.

But as soon as that pressure is off that's going to reemerge.

And be able to deliver growth on the other side of it and so what we're focused on is obviously, we're going to try to manage the $23. One important dynamic to the extent that we're able to but that's not the most critical part for the business. Most critical part is driving the growth brands.

Delivering on the pipeline.

So this is Robert I would add Steve just to clarify I mean, we are a business that can deliver high single digit growth starting 2025, it doesn't makes sense to be cutting investment in 'twenty three and that's what the street consensus is modeling currently so we expect it to invest in this business invest in R&D invest in SG&A to drive that long term growth and given how quickly it will return to that growth I wouldn't expect us to be cutting <unk>.

<unk> and 'twenty three.

Thank you.

Thanks, Steve Operator next question please.

Operator, next question, please.

Thank you.

Our next question comes from Terrence Flynn from Morgan Stanley.

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

Your line is open.

Hi.

Thank you question for Jack.

Thanks for taking the questions.

I was just wondering, obviously, you guys have been speaking with payers about the Humira, positioning for 2023.

Comment on the.

The impact of the buyouts that one until the topic dermatitis, placing.

Placing additional places.

Which obviously won't have the.

Late lag associated with that how you think it could impact the market.

The blank the until the JAK therapy and then.

Neil could you talk to how launched into the commercial potential.

Okay.

11, 40, myeloma, which should teach reported phase III this year.

Yes, Thank you Andrew.

Are you willing to give us any update in terms of how you're thinking about that guidance, figure that you put out a couple years ago?

Important question, so the way that we see the market.

Any change in thinking there?

For the other the other ILS I do think I do think that there will be a segment of conservative dermatologists that will.

Attempt to sequence and I think that largely that there'll be disappointed.

Because it seems the newer agents.

Very very difficult to distinguish from from <unk> I think certainly there could be market access dynamics that start to appear with subsequent ILS I think thats something that that we will watch and you would want to watch.

Whats again, maybe not appreciated as we watched the early quarters of performance in Europe in the first quarter of performance here in the U S is that there is significant amount of early adopters and dermatologists that will go right to a JAK inhibitor.

As I mentioned theyre, not theyre, not always sequencing through duty and it's because of the.

The severity of some of these patients and the level of the clinical involvement is very very significant and so we do see what you would call a significant amount of naive use based on the profile of the JAK inhibitor. Now. These are early adopters. These are people that are already contemplated the risk benefit and I think that's important and so the way that we.

See the market developing is that when physicians would start with <unk>, which will be in a significant proportion of the patient.

It's not clear at all of that their next step will be another IL that is that has been approved or will be approved in fact, we think it's more likely that they will they will move towards the best Jack that can get to these high levels of skin clearance you know the easy 90, plus almost no perceived pitch and I think that's the endpoint that this market is going to move.

<unk> and <unk> is the drug that clearly can deliver on that promise and so that's how we see the market developing and that's why we remain encouraged on the early results around the world from what we're seeing with the agent.

And then, are you able to disclose the CR rate for the recent EpiRitamab Phase 2 trial?

This is neal with respect to the question on <unk>.

Thanks to another clients come over so the Canova study is a study of <unk> in multiple myeloma patients with a particular translocation 11th 2014.

Just wondering how that factors into the decision about whether to seek accelerated approval, here.

Thank you.

We're making extremely good progress with the study and we fully anticipate having a phase III data from this study during the course of 2022.

Terrence, this is Rick.

We know from this particular patient population that were included in earlier earlier studies with some Texas up there because of the sensitive to treatment with the medicine in various combinations.

I'll take the first question for you.

The prevalence of this population is around 20% of multiple myeloma multiple myeloma as you know that the communists hematologic malignancy. So this is a very significant proportion of the multiple myeloma population that could gain benefit from something like I've.

I've mentioned, we're looking forward to being able to communicate the phase III data.

During the course of 2022, thanks for the question.

Thank you Andrew Operator next question. Please thank.

And I'm probably going to answer it a little broader because I think it is important.

Thank you. Our next question comes from Chris Schott from Jpmorgan. Your line is open.

I understand the interest in trying to understand how to model 2023.

Great. Thanks, very much for the questions.

First one from me is just can you elaborate a bit more on rainbow coverage, both in a D and you see I guess I'm trying to get sense of where we are today and what's the outlook for the next few quarters.

As part of that it seems like Youre seeing some nice uptake in your bridge programs can you just comment when you expect we should start to think about.

Those translating over to third party Rx is and that would be maybe more visible to the outside world in terms of how that uptake Youre seeing and then my second question was just on Q1 itself was there any notable either payer adjustments or gross to net issues I guess Humira. For example, it seems like the low single digit growth was a departure.

From recent trends I'm trying to send a little bit better what happened in the quarter is there anything we should just be kind of keeping in mind as we consider the Q1 results.

It's obviously important to us to model 2023 as accurately as possible.

Yes. Thank you Chris it's Jeff So with your first question is we are very confident that we are going to get to high levels of paid access for.

<unk> and sky resist new indications so typically what we'll see based on the approval timeline will be ramping up into the by the middle of the year up into the up into the high nineties in terms of our access for commercial access. So I think that everyone should be confident that that's where you're going to start to.

See this bridge program start to fully convert as the months go by into the paid prescription. So typically thats. The timing, we're looking at Youre going to see very strong momentum on paid access by.

Towards the end of the end of next quarter is what we've guided towards.

And I think if you step back, obviously, contracting is one portion of a variable that will impact, the speed at which biosimilars are able to be adopted in the market.

No.

That's the answer to your first question.

If you think about and maybe just to frame. The Humira question. The Humira fundamentals are.

If you step back and look, there's probably four key variables that will impact what that, adoption rate looks like. One of them is, obviously, what will Humira's access be post-biosimilars entering the marketplace?

And the market fundamentals are quite strong you see.

The markets are performing nicely our market share growth trends, we havent seen any trend shift they have been largely stable. There is some sequential decline based on the size of the market than actually our own brands <unk> and <unk> that are playing very strongly into these markets. What I would say is that in some cases Q1 can be quite unique over the years you've got.

And this is the period where you would normally be doing the contracting around that.

The issue with the the plans resetting their deductibles you've got issues with.

Doctors that have to put in another prior authorization for the year and so you do see some co pay and sort of deductible dynamic, but we think thats really a first quarter type of event and it's largely been very consistent with what we expected. So maybe I don't know Rob if you want to want to build on that a little bit yes, I would just add.

I think we'll do well in being able to be co-positioned versus biosimilars in the vast, majority of covered lives here in the United States.

As you look at back to our guidance for the quarter and we gave guidance in a therapeutic area level, we pretty much came in line with that guidance and so we expected. This dynamic and we're also we're not changing our full year outlook for U S. Humira at 8% growth and that again will be driven by.

Market driving volume growth and so.

It's in line with our expectations I understand street consensus had a different point of view, but we werent surprised by that.

Thanks, Chris.

Operator next question please.

Thank you. Our next question comes from Chris <unk> from Goldman Sachs. Your line is open.

Thank you and good morning, if I could ask on Braemar.

The product I think you'd comment expectations for E MDT approval and yet still frame it as potential for upside can you help us understand perhaps some of the potential there just thinking back to some of the scale of the peak sales opportunity that that drug was characterized previously MDT certainly seems as if it's a potential <unk>.

<unk> opportunity thanks.

Yes. Thank you for the question. It is a significant opportunity so as as we highlighted and Tom highlighted the NDA has been accepted and we're we're confident in the approval I think what we said in the past is that.

But that process isn't done, and we're not in a position to be able to ultimately give, you any further update until we're a little further along in that process.

The second variable that will impact what 2023 looks like is, how will the biosimilars, price?

We don't know that.

Unknown Executive, Perry Siatis, Geoff Stewart, Marcela Pinilla, AbbVie Unknown Executive, [inaudible] Stewart, AbbVie Unknown Executive, Perry Siatis, Geoff Stewart, AbbVie Unknown Executive, Perry, AbbVie Unknown Executive, Perry Siatis, Geoff Stewart, AbbVie Unknown Executive, Perry State Okay, number two, Neal.

Just with the base indications so before we get that approval I mean, the FDA has to still improve it towards the end of the year.

We believe that we can.

Ramp towards a $4 billion opportunity so that would mean our share just in the base indications of.

Our unique profile with the mania, the mixed mania and depression in the bipolar depression.

We'd move somewhere up.

Sort of doubling our share penetration so right now we're at about two 7% <unk> share. So we would really get close to doubling that based on the momentum and then mgd would would build on top of that.

And so it's <unk> it's.

It's significant.

Physicians that we've talked to when we showed them. The profile are very pleased first day no rail are they like Frailer.

They like the the strong efficacy they highlight.

Non sedating a highlight at least verbally a brightening affected the agent minimal weight gain metabolic effects and so as they think about that how that would translate to adjunctive M. D D.

They like that profile. The other piece that we hear is they like the starting dose they liked that starting dose of the one five milligram dose, which is what we believe that ultimately will be approved we will have to see so easy to start easy to take well tolerated and so to your point.

We believe that <unk> will offer some upside and acceleration to the brand's momentum when we achieve it.

Hi, this is Neal Gallagher.

Thanks, Chris Operator next question please.

I'll take the question regarding, efgaritumab.

Thank you. Our next question comes from Bob <unk> from Mizuho Securities. Your line is open.

So we recently reported data from the expansion cohorts of relapsed refractory DLDCL patients. We reported an overall response rate of 63% with a median duration of response, of 12 months.

One thing that's really important to bear in mind is that this is a pretty refractory patient population with a median number of prior therapies of 3.5 and a range of 2.11 at the upper end.

Alright, great. Thanks for taking my question, so let's make it back to him. When we were just talking about around the pricing in <unk>.

And importantly, just under 40% of these patients have failed prior therapy with the CAR T. Overall, the safety profile remains manageable with the vast majority of cases of CRS, a class effect with these agents being grade one and two.

Couple of questions regarding the migraine franchise, so the Bellevue scripts from what we can see publicly.

Third party data it looks like the gross connect.

So net net pricing is back to where we were in <unk> 'twenty one.

Just trying to understand.

This.

It is just the seasonality has changed.

Dynamic or maybe there might be something broader.

Pricing for these products is going down and then tied to that would you look to as you mentioned, let's say the prescription numbers look pretty good as it builds up you're I'm curious now the answer to product in the market.

Does that impact how you're thinking about the opportunity, especially from a pricing side or sort of payer negotiations.

<unk> side any thoughts on sort of.

Link the two together in any way.

I want to get even better at what you have right now.

My thoughts you could share there would be helpful. Thank you.

To directly address your question, we are not yet ready to reveal additional detail about the data.

And in fact, I was just in contact with the team yesterday, and I know that they're working very diligently to get those data on a podium in a meeting in the very near future.

They will be revealed at a forthcoming medical meeting.

<unk>. This is Rob I'll take your first question. So when you look at that there is seasonality in this market in the U S. And so you do see a shift from Q4 to Q1, if you look at year over year you'd see that in Q4 as you mentioned Q1 year over year is relatively flat I would think about it that way for the full year as well. So you do tend to see a super.

In Q1, because of plans resetting that dynamic we see in the U S market, but then over the course of the rest of the year you do see higher pricing. So on average the way to think about it as prices relatively stable.

Okay, thank you, Karen.

And bundle, it's Jeff now so I think look we are pleased with the <unk> momentum I mean actually since we launched <unk> has accelerated so if we have to because we can't see the competitor because you can see the whole thing, but when we factor <unk> bye.

Eight versus 16, and we try to understand the acute dynamic we can see that we're clearly the market leading acute <unk> and that's that's that's nice to see that physicians really like you've <unk>. The markets are robust I think what youre seeing is what Rob highlighted in terms of the overall performance.

It didn't really fully appreciate your second question in terms of the in terms of the access I can give you a broad overview, obviously, where.

We're seeing great momentum with the brand.

Much of the brand is still because the access is ramping is still bridge just like we discussed there with the with the immunology agent. So we think again by the middle of the year, we're going to see commercial access really start to ramp and you'll see the conversion start to take place. What's nice is that we're confident in that we think that our price.

Points, and net price or negotiations are going well and because of its unique profile.

As a as an agent basically the strength of the drug is really significant in terms of its performance against our episodic migraine.

We feel like we're in good shape, and we're going to build on top of that basically 25% in play share which is right now at the top of the league table. So that's that's how we see it we're confident in the access ramp.

Maybe just to clarify the second question then just thank you for all that just is there any advantage is another strategy might have now because you have two approved migraine oral therapies are or is it pretty much similar to what it would be on one for example.

Yeah, it's pretty it's pretty it's pretty similar based on the way that the pricing in the different dynamics work on the other <unk>.

It's not.

It's just sort of a straight it's a straight play on the access there.

Okay. Thank you so much.

Operator, we'll take the next question, please.

Thanks, Operator next question please.

Thank you.

Our next question comes from Geoff Meacham from Bank of America. Your line is open.

Our next question is from Tim Anderson from Wolf Research.

Hey, guys. Good morning. Thanks for the question I just had another one on the ini landscape Rick when you look at the market disruption that youll see in 'twenty, three and 'twenty four.

Your line is open.

Hello.

That's gonna have an indirect effect on on Sky resilient and Rainbow you know when you think pricing and share.

Thanks for taking our question.

What would you guys view as a win.

This is, Alice Nettleton.

Over this period from a new start or switch perspective, or a growth perspective is the first question on the <unk>.

I'm with Tim Anderson.

Second part of it is you know what gives you guys confidence in the market really normalizing after a 24 period. Thank you.

A question on RingVoc, where could in-play market share in a topic eventually get to in your view?

I think as we look at our long range plan.

Don't see or anticipate a dramatic impact.

And are you seeing any switching away from Dupitzent at all?

Provided that 2025 guidance.

And I think it's reflective of the significant growth of <unk> Rainbow.

If you look at those assets and you look at their clinical performance.

You know they really stand out and that's what's driving the kind of volume growth that we're seeing.

<unk>.

You will see obvious price disruption in the humira market from Biosimilars, but I don't anticipate that youre going to see that bleed over in a significant way to those other assets, Jeff do you see any differently I don't see.

Jeff much difference I mean, if you think of it in some ways even on let's take rent book for example, I mean, you could say Wow and prior prior viewpoints, maybe everyone will step behind.

Step behind a.

A biosimilar at some point in the future well, one we didn't think that that would happen wide scale and as the market develops anyway, but even if it did our label is already behind a TNF and so.

When you look at the level of efficacy that <unk>, bringing in those later lines I mean, it's we're really quite insulated from that I would I would put forth and second Sky really is just is a phenomenal asset I mean, the level of performance and what it's doing to transform certainly psoriasis today.

<unk> right now and what we think will happen with with Crohn's and ultimately IBD. When you look at the level of healing and sort of restating that standard of care. We think the assets themselves are quite well positioned for the middle part of the middle part of the decade and that sort of goes to the elements of the planning that Rick talked.

Yeah.

Thanks, Jeff.

Sure.

Next question please.

Thank you.

Thank you. Our next question comes from Gary Nachman from BMO capital markets. Your line is now open.

Yeah, thank you.

Hi, Thanks.

Just following on that last response.

Can you talk more broadly about how you see the expansion of <unk> into the IBD indications. So how is the initial launch for invoke in ulcerative colitis going I know, it's early days, but whats the outlook there given physician receptivity around the product.

<unk>.

Our physicians, saying they are excited to have been vote for crohn's as well.

And also how do you see <unk> fitting in with Crohn's versus bring boat.

And then secondly on aesthetics. It was strong in the first quarter, but did you see any impact in the early part of <unk> from <unk>.

The trend has been more recently in March and April and aesthetics.

Thank you for the question.

Yeah. Thank you. Thank you for the question. It's Jeff again, so we are very very encouraged by the IBD.

I'll give you some context.

Momentum that we can build and we're right on the cusp of it and to give some sense as basically this market the marketed crohn's and you see that it actually has fairly high biologic penetration when we do our research and our engagement with the physicians.

I mentioned that we see roughly in the mid-teens now after about three months, which we're very pleased in, and some more flavor on that.

If you think about the HCPs and the doctors that prescribe in the U.S. now, you've got about 9,000.

Those are the dermatologists and some allergists.

What they typically have done for more than a decade.

Since the since the availability of Remicade and Humira, they really hang on as much as possible to their first line use they try to intensify they do all sorts of things because it's quite scary for the physicians and the patients because no one set a different standard of care. So when you start to look at the healing rates that we start to see.

There's about 3,000 of those physicians that are the big prescribers. They're very productive. Those 3,000 are the ones that are driving Skyrizzy, for example, or other big brands in, psoriasis.

With RIN book and you see the healing of the bowel the remission rates the combination of what we can see this market looks very very good to have both of those assets come in with higher standards of care. So we're very very encouraged and we think that the IBD market is probably underappreciated in terms of what that law.

Looks like and the patients are so challenged with with their disease, because it's quite severe with the with a bowel perforations. The hospitalizations all of these things having to assets is is a great thing to bring to the market certainly in the U S. It's likely we see that with you see today that youre going to have <unk>.

Your line use based on the labeling Sky <unk> is not going to have that limitation. So you can imagine that you have an ability to co position to sequence appropriately to think about how you bring that whole portfolio around the world.

And Thats, how we see it we're quite encouraged that we would have.

Both RIN Volk for Crohn's and RIN, both for <unk> in the market and it's kind of very similar to my comments I made on what's happening with PSA today in in Rheumatology, where both both of those assets RIN vote for PSA and <unk> are in the market together working as the portfolio.

So we see, you know, after just about three months, we see almost 1,000 doctors that have prescribed RingVoc, and so that's driving that 15%.

Some of it depends in terms of where the in-play share ends up, how many of the competitors come in.

We're not really sure that baricitinib will come into the market. You know, we'll have to see.

To get to your first point.

It's been only a month or so with our UC launch, but the physicians gastro is are very encouraged with the profile. They have not seen the level of remission or the level of healing before in any asset so theres quite a wow reaction to the to the efficacy profile.

They realize that they have to think about I've got to think through my patients that are not doing well on TNF or have cycled through a TNF and are struggling and I mentioned thats a pretty large addressable population is at least 50% of the market.

Today, So early qualitative reserve results are quite strong.

The bridge results were also quite strong so we're pleased with the with the gastro launches thus far.

We haven't seen much Pfizer activity yet.

Hey, Gary This is Carrie Strom President at global Allergy Anesthetics and I'll take your question about the aesthetics market and in Q1, we did see U S toxin seller market both growing in the mid 20% and we expect that sort of growth to continue for the rest of 2022 and the way to think.

To give you some sort of international perspective, in the Canadian market, we're seeing where there's really just Dupy and RingVoc at this point after a couple of quarters, we're seeing a 30% in-play share in Canada.

About it is similar amount of absolute volume growth as 'twenty, one but of course off a larger base.

So we are, as I mentioned, very, very encouraged with the early adoption, in particular my comment around how fast, once you see the first prescription take place with some of those productive doctors, how fast they go to the second or third.

And in terms of what's driving that market growth and we're seeing very strong demand trends supported by our increased commercial investments for example.

To give you some flavor of what we see in the U.S., and again, the date is early, we see, as expected, the majority of our use so far in that dynamic market are not switches, necessarily.

We see about, let's say, a third, believe it or not, that are not even exposed to Dupy.

And the doctors are saying, look, I've already given another oral systemic, for example, but the itch and the skin is so severe that they're going to go, I'm going to go right and get the relief.

And then maybe the other two-thirds, you see DUPI partial responders, particularly related, to the itch just isn't suppressed as much and they still have some skin involvement, or there is, as we've highlighted before, a warehouse of DUPI non-responders that has been built up over the last four years.

Kris consumer activation for acquisition and retention field force expansions in key markets and we see these trends also supported just by fundamentals and aesthetics that will.

And the long term people think about the Fedex more like health and wellness.

It's been much more just taking mackay and we'd see factors like social media and word of mouth, continuing to drive aesthetics and the future of your question around the pandemic I would say that we are seeing an impact right now in China, and we anticipate that this recent surge as COVID-19 cases in China.

So that's the behavior that we see.

Which has resulted in lockdowns across several major cities has reduced patient traffic into aesthetic offices in China, and China is a top market for aesthetic. So we expect this to impact our near term international performance for both toxins and failures I should also mention that Russia.

<unk> is a key market for sellers globally.

And as the tragic events in the Ukraine has unfolded, we have suspended operations as far as Fedex business in Russia. So.

Though absolute athletic sales in Russia are modest like I said, Russia is among one of the largest markets in the world. So we expect to see an impact on our stellar performance in coming quarters.

These dynamics, we do not need to change our total guidance for aesthetics. So we see our continued robust toxin performance in the U S.

Again, I'm very encouraged on the early results, not just in the U.S., but around the world.

RINVOKE is going to be a real player in this underserved market.

To offset that anticipate a transitory impact in both China and Russia.

Thank you, Alex.

Thanks, Gary.

Operator, next question, please.

Next question please.

Thank you.

Thank you. Our next question comes from Robyn Karnofsky from Jewish Securities. Your line is open.

Our next question is from Steve Scala from Cowan.

Your line is open.

Thank you.

Great. Thanks for taking my question so for FERC.

Two questions.

At current a map.

I just have a question on accelerated approval given the recent FCA.

And discussion around the <unk> kinase class and sort of hinting that they want control data for accelerated approval. How do you view that in light of that panel.

We have accelerated approval.

And then second just.

A little bit more questions around the bridge program. I think you said that you can expect more payment reimbursement come in line middle of the year.

To me how long people stay in the bridge program and how you expect that program to continue and how many people might confuse me is that after payers come online.

First on epiridomab, the data looks great.

Hey, Robyn, it's Neil I'll start off with the question around at Griffith amount, but maybe just a comment generally come to an accelerated improvement.

Could this molecule immediately start taking share from CAR-T, or do you think physicians, will want to see durability data before selecting a bispecific ahead of a cell therapy?

So that's the first question.

The second question is, I'm trying to sift through the answer to the Humira question, just a moment ago.

Overall, I think because we're all aware prompted your question that the agencies in the course of in the process of updating its guidance with respect to accelerated approval.

On the one hand, it seems we need to consider that Humira could be more resilient in 2023, than expected.

We haven't seen the titles, we give that guidance, but we anticipate hearing more from them during the course of 2022.

As I alluded to and I'm not going to repeat what I said earlier on it but if you have good data, but we are extremely pleased with kind of the molecule is performing and it is our intent to engage with the agency based on the data that we've topline recently it is our intent to engage with the agency in a conversation to explore a path to accelerated approval and likewise.

With some of our other programs. We recently got a b to D designation for <unk>. For example earlier this year with a 54% response rate in C met high non small cell lung cancer.

Again, it is our intent when we have data that are these the strong to continue to engage with the with the agency.

On those programs to explore potential constructs.

On the other hand, the street needs to raise spending assumptions.

So thanks for the question, Okay, Hi, it's Jeff just a comment on that Youre Bridge question. Thank you for that so the bridge transition will be very efficient. So what I mean by that is because of the.

So would you object to either of those conclusions based on what was stated?

Thank you.

Connections that we have with the payers and our specialty pharmacy network.

We're able to two once access is achieved rapidly and appropriately transition patients from the bridge to basically there.

Paid a pharmacy and their prescription so theres not going to be lingering bridge effects, particularly in the immunology space. So once it starts to move in that access ramps. The bridge transition is quite fast and that can be within weeks or a month and we know that that's the case because we have the models from.

Our.

Earlier launches from Sky resilient revoke so ultimately once you start to achieve those high levels of access bridge bridge programs dropped very very fast and the vast majority of the very vast majority is paid prescriptions. So it's very efficient and I hope that helps.

Thanks, Steve.

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

This is Neil.

Thank you. Our final question comes from Josh <unk> from Evercore ISI. Your line is open.

I'll take the first question on epiridomab.

The fact that we saw such remarkable activity in a patient population that had failed CAR-T, does not imply that the medicine should be positioned after failure of CAR-T.

Great. Thanks for fitting me in and congrats my concern for service seats at your long term outlook improve again or am I misunderstanding the contingent consideration line that line item. Thanks, so much.

I think they're two very different classes of medicines, as you know.

CAR-T has significant challenges with respect to the need for the maritime prior to administration.

So Josh it's Rob So if you look at the contingent consideration actually.

I think Rob and I will handle the second question for you.

Whereas the safety profile with epiridomab is extremely manageable.

And again, I don't want to repeat what I said earlier on around CRS.

But overall, we see a very strong benefit-risk profile emerging for the medicine.

And therefore, our intention is to move the medicine into earlier lines of therapy, initially, gain an approval with respect to gain approval in RAS, refractory DL-BCL, and after that, move the medicine into earlier lines of therapy.

Steve, this is Rick.

It's a fair value liability it went down this quarter because of discount rates. So we have always have to you have to pay attention to discount rate movement. So we saw the average discount rate increased by about 130 basis points Youre seeing obviously as rising interest rates are taking hold the market. That's something we have to take into account because we got the mark to market every quarter.

Yeah, look, I think it's a great question.

And we've gotten that question a lot.

You know, what's the erosion going to be in 23?

And is it going to be lighter in 23 and therefore spill more into 24?

And I think that's a reasonable question to start to think through.

I'd say as I step back and look at it, I would tell you this.

That would force more of it out into 24.

Look, at the end of the day, it could be lighter in 23.

If I look at the business, that's a good thing. It would give us higher cash flows in 23 than what we would be projecting now.

Ultimately, I think there will be a settling out between 23 and 24, where it will still, get to the levels that we have described, or at least that we're modeling.

And I think the important thing is, look, Chimera is going to play out over these two-year period of time.

That's the critical aspect of it.

What's important to AbbVie, though, is what's that underlying growth that's driving the business, and is going to sustain the growth on the other side of the LOE?

The SkyRizzies, the RenVokes, our neuroscience pipeline, aesthetics, it's all of those major growth drivers that we have because that growth is going to be suppressed in 23 and somewhat maybe in 24.

But as soon as that pressure is off, that's when it will reemerge and be able to deliver growth on the other side of it.

And so what we're focused on is obviously we're going to try to manage the 23-24 dynamic to the extent that we're able to.

But that's not the most critical part for the business.

Operator, next question, please.

The most critical part is driving these growth brands and delivering on the pipeline.

Look at our release, we had a similar we had a decrease last year as well.

This is Rob.

What I would add, Steve, just to clarify, I mean, we have a business that's going to deliver high single-digit growth starting in 2025.

It doesn't make sense to be cutting investment in 23, and that's what the street consensus is modeling currently. So we expect to invest in this business, invest in R&D, invest in SG&A to drive that long-term growth. And given how quickly we'll return to that growth, I wouldn't expect us to be cutting investment in 23.

Thank you.

Thank you.

Our next question comes from Andrew Baum from Citi.

We had discount rate increase in Q1 of last year, albeit to a lesser extent so.

Thanks, Steve.

Your line is open.

So thats what Youre seeing is just really the discount rate movement no other real fundamental changes to the valuation of that liability.

Got it thanks for clarifying.

Thank you.

A question for Jack.

Well, thank you Josh.

Perhaps you could comment on the impact of IL-31 inhibitors in atopic dermatitis where we're expecting additional data, which obviously don't have the JAK labeling associated with it, how you think it's going to impact the market in terms of delaying the onset of JAK therapy.

And then second, for Neil, could you talk to how large you see the commercial potential for inflexa in T11-14 myeloma, which is due to report its phase three this year?

The first one for me is just, can you elaborate, a bit more on RINVOC coverage, both in AD and UC?

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

Yeah, thank you, Andrew.

I guess showing a sense of where we are today and what's the outlook for the next few quarters.

And then my second question was just on Q1 itself.

So important question.

And maybe as part of that, it seems like you're seeing some nice uptake in your BRIDGE programs.

So the way that we see the market for the other ILs, I do think that there will be a segment of conservative dermatologists that will attempt to sequence.

Can you just comment when you expect we should start to think about those translating over to third-party Rx's and that will be maybe more visible to the outside world in terms of how, you know, that uptake you're seeing?

And I think that largely that they'll be disappointed, because it seems the newer agents are very, very difficult to distinguish from dupixent.

I think certainly there could be market access dynamics that start to appear with subsequent ILs.

I think that's something that we will watch and you would want to watch.

I think what's, again, maybe not appreciated as we watch the early quarters of performance in Europe and the first quarter of performance here in the U.S, is that there's significant amount of early adopters and dermatologists that will go right to a JAK inhibitor.

Were there any notable either payer adjustments or growth to net issues?

As I mentioned, they're not always sequencing through dupixent.

I guess Humira, for example, it seems like the low single-digit growth was a departure from recent trends.

Thank you, Chris.

And it's because the severity of some of these patients, and the level of the clinical involvement is very, very significant.

I'm just trying to understand a little bit better what happened in the quarters and anything we should just be kind of keeping in mind as we consider the Q1 results.

It's Jeff.

That concludes today's conference call.

And so we do see what you would call a significant amount of naive use, based on the profile of the JAK inhibitor.

Okay.

Thanks.

So with your first question is, we're very confident that we are going to get to high levels of paid access for RINVOKE and Sky RISD's new indications.

If you'd like to listen to a replay of the call, please visit our website at investors.appy.com.

Thank you.

Now, these are early adopters.

Yeah.

So typically what we'll see based on the approval timeline, you know, we'll be ramping up into the by the middle of the year up into the up in the high 90s in terms of our access for commercial access.

Thanks again for joining us.

That concludes today's conference call.

You may disconnect at this time.

Thank you that concludes today's conference call. Thank you for your participation you may disconnect at this time.

These are people that have already contemplated the risk-benefit, and I think that's important.

So I think that everyone should be confident that that's where you're going to start to, see this BRIDGE program start to fully convert as the months go by into the paid prescription.

Thank you for your participation.

And so the way that we see the market developing is that when physicians would start with dupi, which will be in a significant proportion of the patients, it's not clear at all that their next step will be another IL that has been approved or will be approved.

So typically that's the timing we're looking at. You're going to see very strong momentum, on paid access by towards the end of the end of next quarter is what we've guided towards.

In fact, we think it's more likely that they will move towards the best JAK, that can get to these high levels of skin clearance, you know, the easy 90 plus almost no perceived itch.

So that's that's the answer to your first question.

And I think that's the end point that this market's going to move towards.

I think if you think about maybe, just to frame the Humira question, the Humira fundamentals are in the market.

And Rinvoke is the drug that clearly can deliver on that promise.

Fundamentals are quite strong.

And so that's how we see the market developing, and that's why we remain encouraged on the early results around the world from what we're seeing with the agents.

You see, you know, the markets are performing nicely.

This is Neil.

Our market share growth remains.

With respect to the question on Xenotoclax Canova. So the Canova study, is a study of Xenotoclax in multiple myeloma patients with a particular translocation C11-14.

We haven't seen any trend shift.

We're making extremely good progress with the study, and we fully anticipate having, a phase 3 data from the study during the course of 2022.

They've been largely stable.

We know from this particular patient population that were included in earlier studies with Xenotoclax that they are explicitly sensitive to treatment with the medicine in various combinations.

There's some sequential decline based on the size of the markets and actually our own brand Sky RISD and RINVOKE that are playing very strongly.

The prevalence of this population is around 20% of multiple myeloma, and multiple myeloma, as you know, is the common etymologic malignancy. So this is a very significant proportion of the multiple myeloma population that could gain benefits from Xenotoclax.

What I would say is that in some cases, Q1 can be quite unique over the years.

As mentioned, we're looking forward to being able to communicate the phase 3 data during the course of 2022.

You've got the issue with the plans resetting their deductibles.

Thanks for the question.

You've got issues with doctors that have to put in another prior authorization for the, year, and so you do see some copay and sort of deductible dynamic, but we think that's really a first quarter type of event, and it's largely been very consistent with what we expected.

Thank you.

So maybe, I don't know, Rob, if you want to build on that a little bit.

Andrew, Operator, next question please.

Yes, I would just add that if you look back to our guidance for the quarter, and we gave, guidance at a therapeutic area level, we pretty much came in line with that guidance, and so we expected this dynamic, and we're also, you know, we're not changing our full-year outlook for U.S. humanity at 8% growth, and that again will be driven by, you know, market driving volume growth, and so it's in line with our expectations.

Thank you.

I understand street consensus had a different point of view, but we weren't surprised by, that.

Our next question comes from Chris Schott from J.P. Morgan.

Thanks, Chris.

Your line is open.

Operator, next question, please.

Great.

Thank you.

Thanks very much for the questions.

Our next question comes from Chris Shibutani from Goldman Sachs.

Your line is open.

Thank you.

Good morning.

If I could ask on Braylor, the product, I think you comment expectations for a MDD approval, and yet still frame it as potential for upside.

Can you help us understand, perhaps, some of the potential there, just thinking back, to some of the scale of the peak sales opportunity that that drug was characterized previously, MDD certainly seems as if it's a potential significant opportunity.

Thanks.

Yeah, thank you for the question, and it is a significant opportunity.

So, as we highlighted and Tom highlighted, you know, the NDA has been accepted, and we're, confident in the approval.

I think what we've said in the past is that just with the base indication, so before we, get that approval, I mean, the FDA has to still approve it towards the end of the year, we believe that we can ramp towards, you know, a $4 billion opportunity.

So that would mean our share, just in the base indications of a unique profile with, the mania, the mixed mania and depression, the bipolar depression, you know, we'd move somewhere up, you know, sort of doubling our share penetration.

So, you know, right now we're at about 2.7% TRX share, so we'd really get close to doubling, that based on the momentum, and then MDD would build on top of that.

And so it's significant.

I mean, the physicians that we've talked to when we show them the profile are very pleased.

First, they know RALAR, they like RALAR.

They like the strong efficacy, they highlight, you know, non-sedating, they highlight at, least verbally a brightening effect of the agent, minimal weight gain, metabolic effects, and so as they think about that, how that would translate to adjunctive MDD, they like that profile.

The other piece that we hear is they like the starting dose.

They like that starting dose of the 1.5 milligram dose, which is what we believe that ultimately, will be approved, we'll have to see.

So easy to start, easy to take, well-tolerated, and so to your point, we believe that MDD, will offer some upside and acceleration to the brand's momentum when we achieve it.

Thanks, Chris.

Operator, next question, please.

Thank you.

Our next question comes from Vamil Divan from Mizuho Securities.

Your line is open.

Hi, great.

Thanks for taking my question.

So this may get back to some of what we were just talking about around the pricing in 1Q.

But I had a couple of questions regarding the migraine franchise.

So the Ubrella v. Scripps, from what we can see publicly out there, third party data, it looks like the growth to net pricing is back to where we were in 1Q21.

I'm just trying to understand if this is just a seasonality of things or 4Q to 1Q dynamic, or maybe there might be something broader, you know, where net pricing for these products is going down.

And then tied to that, which you looked at, as you mentioned, looked at the prescription numbers are pretty good as it builds up here.

I'm curious, now that you have sort of two products in this market, does that impact how you're thinking about the opportunity, especially from a pricing side or sort of payer negotiation side?

Is there any thoughts on sort of bundling the two together in any way?

To potentially get even better access than what you have right now?

So any thoughts you could share there would be helpful as well.

Thank you.

So, Vamal, this is Rob.

I'll take your first question.

So when you look at, you know, there is seasonality in this market in the U.S. And so you do see a shift from Q4 to Q1.

If you look at year over year, you'd see that in Q4, as you mentioned, Q1 year over year is relatively flat.

I would think about it that way for the full year as well.

So you do tend to see a suppression in Q1 because of, you know, plans resetting that dynamic we see in the U.S. market.

But then, you know, over the course of the rest of the year, you do see higher pricing.

So on average, the way to think about it is, you know, price is relatively stable.

And Vamal, it's Jeff now.

So I think, look, we are pleased with the Ubrelvi momentum. I mean, actually, since we launched QLIPTA, Ubrelvi has accelerated.

So if we have to, because we can't see the competitor, because you can see the whole thing.

But when we factor NERTEC by, you know, eight versus 16, and we try to understand the acute dynamic, we can see that we're clearly the market leading acute CGRP.

And that's nice to see.

The positions really like Ubrelvi.

The markets are robust.

I think what you're seeing is what Rob highlighted in terms of the overall performance.

I didn't really fully appreciate your second question in terms of the access.

I can give you a broad overview.

Obviously, we're seeing great momentum with the brand.

You know, much of the brand is still because the access is ramping is still bridge, just like we discussed there with the immunology agent.

So we think, again, by the middle of the year, we're going to see commercial access really start to ramp.

And you'll see the conversion start to take place.

What's nice is that we're confident in that.

We think that our price points and net price or negotiations are going well.

And because of its unique profile as an agent, basically, the strength of the drug is really significant in terms of its performance against episodic migraine.

We feel like we're in good shape.

And we're going to build on top of that, basically, 25% in-place share, which is right now at the top of the lead table.

So that's how we see it.

We're confident in the access ramp.

Maybe just to clarify the second question then, just thank you for all that.

Is there any advantages or other strategies you might have now, because you have two approved migraine oral therapies or is it pretty much similar to what it would be if you had one or the other?

Yeah, it's pretty, it's pretty, it's pretty similar based on the way that the the pricing, and the different dynamics work on the other CGRP.

It's, it's, it's not, it's just sort of a straight, it's a straight play on the access there.

Okay, thank you so much.

Thank you, Vamil.

Thanks, Vamil.

Operator, next question, please.

Thank you.

Our next question comes from Geoff Meacham from Bank of America.

Your line is, open.

Hey, guys.

Morning.

Thanks for the question.

I just had another one on the I&I landscape.

You know, Rick, when you look at the market disruption that you'll see in 23 and 24, you, know, presumably that's going to have an indirect effect on Sky RISD and Renvoke, you know, when you think pricing and share.

What would you guys view as a win, you know, over this period from a new start or switch perspective or growth perspective is the first question.

The second part of it is, you know, what gives you guys confidence in the market really normalizing, after a 2024 period?

Thank you.

I think as we look at our long range plan, we don't see or anticipate a dramatic impact.

We've provided that 2025 guidance.

And I think it's reflective of significant growth of Sky, RISD and Renvoke.

You know, if you look at those assets, and you look at their clinical performance, you know, they really stand out.

And that's what's driving the kind of volume and growth that we're seeing.

And I think you will see obvious price disruption in the Humera market from biosimilars.

But I don't anticipate that you're going to see that bleed over in a significant way to those other assets.

Jeff, do you see anything differently?

Yeah, I don't see, Jeff, much difference.

I mean, if you think of it in some ways, even, on let's take Renvoke, for example, I mean, you could say, wow, you know, in prior, prior viewpoints, maybe everyone will step behind a step behind a, you know, a biosimilar at some point in the future.

Well, one, we didn't think that that would happen wide scale in as the market develops anyway.

But even if it did, our label is already behind a TNF.

And so when you look at the level of efficacy that Renvoke's bringing in those later lines, I mean, it's really quite insulated from that, I would put forth.

And second, Skyrizzy is just is a phenomenal asset.

I mean, the level of performance and what it's doing to transform certainly psoriasis today, PSA right now, and what we think will happen with Crohn's and ultimately IBD, when you look at the level of healing, and sort of restating that standard of care, we think the assets themselves are quite well positioned for the middle part of the middle part of the decade.

And that sort of goes to the elements of the planning that Rick talked about.

Thanks, Jeff.

Operator, next question, please.

Thank you.

Our next question comes from Gary Nachman from BMO Capital Markets.

Your line, is open.

Hi, thanks.

First, just following on that last response, just, you know, can you talk, more broadly about how you see the expansion of Renvoke and Skyrizzy into the IBD indication?

So, how is the initial launch for Renvoke and ulcerative colitis going?

I know it's, early days, but, you know, what's the outlook there, given physician receptivity around the product?

Our physicians saying they're excited to have RINVOC for Crohn's as well.

And also, how do you see SCARIZI fitting in with Crohn's versus RINVOC?

And then secondly, on aesthetics, it was strong in the first quarter, but did you see any impact in the early part of, 1Q from Omicron?

And what have the trends been more recently in March and April in the aesthetics?

Yeah, thank you.

Thank you for the question.

It's Jeff again.

So you know, we are, very, very encouraged by the IBD momentum that we can build.

And we're right on the cusp of it.

And to give some sense is basically this market, the market of Crohn's and UC, it actually has fairly high biologic penetration.

When we do our research and our engagement with the physician, what they typically have done for more than a decade, since the availability of, you know, Remicade and then Humira, they really hang on as much as possible to their first-line use.

They try to intensify, they do all sorts of things, because it's quite scary for the physicians and the patients because no one set a different standard of care.

So when you start to look at the healing rates that we start to see with RINVOC and UC, the healing of the bowel, the remission rate, the combination of what we can see, this market looks very, very good to have both of those assets come in with higher standards of care.

So we're very, very encouraged, and we think that the IBD market is probably underappreciated in terms of what that looks like. And the patients are so challenged with their disease because it's quite severe with the, bowel perforations, the hospitalizations, all of these things.

Having two assets is a great thing to bring to the market.

Certainly in the U.S., it's likely, we see that with UC today, that you're going to have later line use based on the labeling.

Sky RISD is not going to have that limitation.

So you can imagine that you have an ability to co-position, to sequence appropriately, to think, about how you bring that whole portfolio around the world, and that's how we see it.

We're quite encouraged that we would have both RINVOC for Crohn's and RINVOC for Sky RISD in the market, and it's kind of very similar to my comments I made on what's happening with PSA today in rheumatology, where both of those assets, RINVOC for PSA and Sky RISD PSA, are in the market together working as a portfolio.

To get to your first point, you know, it's been only, you know, a month or so with our UC launch, but the physicians, the gastros, are very encouraged with the profile. They've not seen the level of remission or the level of healing before in any asset, so there's quite a wow reaction to the efficacy profile.

They realize that they have to think about, I've got to think through my patients that are not doing well on TNF or have cycled through a TNF and are struggling, and I mentioned that's a pretty large addressable population.

It's at least 50% of the market today, so early qualitative results are quite strong, and the bridge results are also quite strong, so we're pleased with the gastro launches thus far.

Hi, Gary.

This is Kari Strom, President of Global Allergan Aesthetics, and I'll take your question about the aesthetics market, and in Q1, we did see U.S. toxin filler markets both growing in the mid-20s percent, and we expect that sort of growth to continue for the rest of 2022, and the way to think about it is similar amount of absolute volume growth as 21, but of course off of a larger And in terms of what's driving that market growth, we're seeing very strong demand trends, supported by our increased commercial investments, for example, increased consumer activation for acquisition and retention, field force expansions in key markets.

And we see these trends also supported just by fundamentals and aesthetics that will continue, in the long term.

People think about aesthetics more like health and wellness.

It's been much more destigmatized, and we see factors like social media and word of, mouth continuing to drive aesthetics in the future.

Your question around the pandemic, I would say that we are seeing an impact right now, in China, and we anticipate that this recent surge of COVID cases in China, which has resulted in lockdowns across several major cities, has reduced patient traffic into aesthetic offices in China.

And China is a top market for aesthetics, so we expect this to impact our near-term, international performance for both toxins and fillers.

I should also mention that Russia is a key market for fillers globally, and as the tragic, events in the Ukraine have unfolded, we have suspended operations for our aesthetics business in Russia.

So although absolute aesthetics sales in Russia are modest, like I said, Russia is among one, of the largest filler markets in the world, so we expect to see an impact on our filler performance in coming quarters.

But despite these dynamics, we do not need to change our total guidance for aesthetics.

We see our continued robust toxin performance in the U.S. to offset this anticipated transitory, impact in both China and Russia.

Thanks, Gary.

Great.

Thank you.

Operator, next question, please.

Thank you.

This question comes from Robin Karnoskis from Truist Securities.

Your line is open.

Great.

Thanks for taking my question.

So for hep caritamap, I just have a question on accelerated approval.

Given the recent FDA discussion around the PI3 kinase class and sort of hinting that, they want controlled data for accelerated approval, how do you view that in light of that panel, the likelihood of accelerated approval?

And then second, just a little bit more questions around the BRIDGE program.

You think you said that you're going to expect more payment reimbursement coming online in, the middle of the year.

Could you talk to me how long people stay in the BRIDGE program and how you expect that, BRIDGE program to continue and how many people might continue to use it after payers come online?

Thanks.

Hey, Robin.

It's Neil.

I'll start off with the question around hep caritamap, but maybe just a general comment, on accelerated approval overall, I think, because we're all aware, and this prompted your question, that the agency is in the course of, in the process of updating its guidance with respect to accelerated approval.

We haven't seen the totality of that guidance, but we anticipate hearing more from them during, the course of 2022.

As I alluded to, I'm not going to repeat what I said earlier on about the FCO data, but, we are extremely pleased with how the molecule is performing, and it is our intent to engage with the agency. Based on the data that we've top-lined recently, it is our intent to engage with the agency, in a conversation to explore a path to accelerated approval.

And likewise, with some of our other programs, we recently got a BTD designation for TELISA-V, for example, earlier this year with a 54 percent response rate in C-met high non-small-cell lung cancer.

Again, it is our intent, when we have data that are this strong, to continue to engage, with the agency on those programs to explore.

Hi, it's Jeff, just a comment on your bridge question, thank you for that.

So the bridge transition will be very efficient, so what I mean by that is because of the connections, that we have with the payers and our specialty pharmacy network, we're able to, once access is achieved, rapidly and appropriately transition patients from the bridge to basically their paid pharmacy and their prescriptions, so there's not going to be lingering bridge effects, particularly in the immunology space, so once it starts to move and that access ramps, the bridge transition is quite fast, and that can be within weeks or a month, and we know that that's the case because we have the models from our earlier launches from Skyrizzy and Rinvoke, so ultimately once you start to achieve those high levels of access, bridge programs, drop very, very fast, and the vast majority, the very vast majority is paid prescriptions, so it's very efficient, and I hope that helps.

Thanks, Robin.

Operator, we have time for one final question.

Thank you.

Our final question comes from Josh Schimmer from Evercore ISI.

Your line is open.

Great, thanks for fitting me in, and congrats to both Mike and Tom.

First, Skyrizzy, did your long-term outlook improve again, or am I misunderstanding the, contingent consideration line item?

Thanks so much.

So, Josh, it's Rob.

So, if you look at the contingent consideration, actually, it's a fair value liability.

It went down this quarter because of discount rates, so we always have to pay attention, to discount rate movement, so we saw the average discount rate increase by about 130 basis points.

You're seeing, obviously, as rising interest rates are taking hold of the market, that's, something we have to take into account because we have to mark this to market every quarter, If you look at our release, we had a similar-we had a decrease last year as well.

Again, we had discount rates increase in Q1 of last year, albeit to a lesser extent, so, that's what you're seeing is just really the discount rate movement, no other real fundamental changes to the valuation of that liability.

Got it.

Thanks for clarifying.

Well, thank you, Josh.