Q4 2019 Earnings Call

Good morning, and thank you for standing by welcome to the L. before.

Quarter 2019 earnings conference call.

Rick Gonzalez: We delivered another strong quarter with adjusted earnings per share exceeding the midpoint of our guidance. Our adjusted EPS of $2.21 represents growth of more than 16% versus the fourth quarter of 2018. Total Adjusted Operational Sales Growth of 5.3% was also ahead of our expectations for the quarter, driven by continued strong performance in both immunology and hematological oncology. Our performance this quarter tops off another strong year for AbbVie. For the full year 2019, we delivered adjusted earnings per share growth of 13%.

Participants will be able to listen only until the question and answer portion of the call and you may ask a question by pressing star one on your Touchtone phone I would now like to introduce misled shape, Vice president of Investor Relations.

Good morning, and thanks for joining.

Also in the call with me today I reconcile instrument the board and she can Chief Executive Officer, Michael Severino, Vice Chairman and President and Rob Michael Executive Vice President and Chief Financial Officer before we get started I remind you that some statements. We make today maybe considered forward looking statements for purposes of the private Securities Litigation Reform Act at night.

95.

He 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.

Rick Gonzalez: We have driven strong commercial, operational, and R&D execution, which has allowed us to substantially grow despite the impact of international biosimilar competition. We saw excellent performance in our hematological oncology business, which drove operational growth of more than 39 percent in the year. We have built a substantial franchise with Imbruvica and Venclexta, which combined for nearly five and a half billion dollars in combined revenue with strong double-digit growth expected once again in 2020. Additionally, Embruvica remains the clear market share leader across all lines of therapy in CLL.

Additional information about these risks and uncertainties is included in our 2018 annual report on form 10-K and in our other I see see filings Abby undertakes no obligation to.

Update these forward looking statements, except as required by law on today's conference call. That's in the past non-GAAP financial measures will be used to help investors understand at these ongoing business performance. These non-GAAP financial measures are reconciled the comparable GAAP financial measures and our earnings release and regulatory filings from today, which can be found on their website. Please note.

We have also posted slides to our website to supplement some of the content will be covering this morning. Following our prepared remarks, we'll take your questions. So with that I'll now turn call over Tourette. Thank you Liz.

Rick Gonzalez: With the largest body of clinical evidence, a robust survival benefit, and the highest category rating and treatment guidelines today, we remain confident that Embruvica will be a significant growth contributor for many years to come, and Clexa will also contribute substantially to our growth in 2020, with continued share expansion expected in both the broad relapsed refractory and frontline CLL segments, as well as continued penetration in frontline AML. In our immunology business, the launches of Skyrizzy and RINVOC are going exceptionally well. Both Skyrizzy and RINVOC have demonstrated strong differentiated efficacy in their initial indications, and we are making considerable progress to expand their uses in several additional immune-mediated diseases. Skyrizzy is already having an impact on AbbVie's growth, with sales of approximately $215 million in the fourth quarter, which already equates to an annualized run rate approaching $900 million, and we expect robust growth in 2020. The launch execution has been nothing short of exceptional.

Good morning, everyone and thank you for joining us today, I'll discuss our fourth quarter and full year 2019 of the.

Payments as well as our 2020 expectations for Abbvie on a standalone basis, we will provide combined dabir now again guidance. After the close of the plan transaction. Mike will then provide an update on recent advancements across R&D programs and Rob will discuss.

Sure its performance and our 2020 guidance in more detail following our remarks, we will take two questions.

We delivered another strong quarter with adjusted earnings per share exceeding the midpoint of our guidance our adjusted EPS of two hours and 21 cents represents growth of more than.

<unk> said this is the fourth quarter of 2018.

Total adjusted operational sales growth of 5.3% was also ahead of our expectations for the quarter.

Driven by continued strong performance in both immunology and humans logical oncology.

Performance this quarter tops off another.

Well I'm here for Abbvie.

For the full year 2019, we delivered adjusted earnings per share growth of 13%.

Rick Gonzalez: In a very short time frame, Sky RISD has established the leading in play, psoriasis patient share, which includes both new and switching patients at roughly 25 percent. Sky Rizzi is redefining the standard for efficacy and safety in the psoriasis market, where it has not only demonstrated superiority to Chimera, the gold standard of care, but also outperformed other novel agents, including Cosentic Sky Rizzi's commercial access is now at parity to Chimera and above 95%. While still early in the launch, we're also seeing robust demand trends for Renvo, which is performing well ahead of comparable analogs in the RA segment. In its first full quarter, RIMBOK was on the market.

We have you ever been strong commercial operational and R&D execution, which has allowed us to substantially grow through the impact of international Biosimilar.

Petition.

We saw excellent performance at our Hematological oncology business, which drove operational growth of more than 39% in the year.

And build a substantial franchise with imbruvica and Venclexta, which combine nearly five and a half billion dollars and combined revenue was.

Tom double digit growth expected once again in 2020.

Imbruvica remains the clear market share leader across all lines of therapy in CLL.

The largest body of clinical evidence a robust survival benefit and the highest category rating in treatment guidelines today, we remain.

Incompetent imbruvica will be a significant growth contributor for many years to come.

Rick Gonzalez: We estimate more than 7,600 prescriptions were filled, including both paid prescriptions and those who received RINVOC through our Bridge Access Program. Based on this level of prescription volume, RINVOC is currently capturing approximately 9% of in-play RA patients and has surpassed the in-play share for several other established brands. The cannibalization of Chimera market share in this segment remains very low thus far.

Flex don't will also contribute substantially door growth in 2020, we continued share expansion expected in both the broad relapsed refractory and frontline CLL segments.

As well as continued penetration in front line I know.

And our immune oncology business the launches of sky raising rents are going exceptionally well most got rosy in remote have demonstrated strong differentiated African C and their initial indications and we are making considerable.

Rick Gonzalez: Feedback from prescribing physicians has been very positive, and the strong benefit-risk profile RINVOKE has demonstrated across our registrational trials has supported very rapid and broad formulary coverage for RINVOKE. Commercial access to RINVOKE is now at more than 95%, and we expect paid prescription volume to increase significantly throughout 2020 as a result. Humira in the U.S. continues to generate strong revenue, driving more than a billion dollars of growth in 2019 and will remain a significant contributor to growth again in 2020. The international human error dynamics remain consistent with our expectations, with 2019 revenues down roughly 28% on an operational basis.

A little more progress to expand their uses in several additional immune mediated diseases.

[noise] Sky raising is already having an impact on abbey's growth with sales of approximately $215 million in the fourth quarter.

It's already equates to an annualized run rate.

Approaching $900 million and we expect robust growth in 2020.

The launch execution has been nothing short of exceptional in a very short timeframe Scott raise he has established the leading in play psoriasis patients here, which includes both new.

Okay and switching patients at roughly 25%.

Scott Rizzi is redefining the standard for efficacy and safety and this rise this market where it is not only demonstrated superiority shoot mirror the gold standard of care, but also outperformed other novel agents, including.

Rick Gonzalez: Overall, I'm extremely pleased with the performance and the outlook for our immunology franchise. We had previously commented that Skyrizzy and Wimboke would deliver more than a billion dollars of revenue combined in 2020. Our 2020 guidance now contemplates that these two products will contribute approximately 1.7 billion dollars in revenue together this year. Since our inception, we have focused on building a robust pipeline and adding growth platforms that would allow AbbVie to absorb the eventual impact of biosimilar competition in the U.S. and maintain a strong and growing business. We continue to make excellent progress toward that objective.

Cosentyx.

I was east commercial access is now at parity to Humira and above 95%.

Well, it's still early in the launch we're also seeing robust demand trends for rent dog, which is performing well.

I had a comparable analogs and they are a segment.

In the first full quarter remote was on the market, we estimate more than 7600 prescriptions were filled.

[noise], including both paid prescriptions and those who received Brembo walbridge access program.

Rick Gonzalez: As I just highlighted, the better-than-expected launch trajectories of SkyRISE and WINVOX and the continued strong performance of our hematological oncology franchise have further increased our level of confidence that these platforms will drive significant growth over the long term. Our R&D productivity over the past seven years has resulted in numerous new products, which collectively contributed approximately $9 billion in revenue in 2019. And our R&D pipeline continues to develop nicely, with multiple programs well underway to expand the breadth of indications for SCIRISI and RENVO, as well as the advancement of a significant number of early and mid-stage programs, six of which will have proof-of-concept data readouts in 2020. AbbVie's R&D pipeline has been phased-gated from the time we launched as an independent company back in 2013. Our initial priority was to develop next-generation assets that would be superior to Humira and other competitive alternatives within our key immunology disease areas. And as you have seen, SCIRISI and RIMVO have demonstrated that type of performance across multiple clinical trials.

Based on this level of this.

It's in volume.

Tim Gokey is currently capturing approximately 9% of in play or a patients and its surpass the in place chair for several other established brands the cannibalization of Humira Marketshare and this segment remains very low thus far.

[noise].

Back from prescribing physicians, who has been very positive in the strong benefit risk profile window, because demonstrated across our registrational trials has supported very rapid and broad formulary coverage for rent a commercial access for Red dog is now more than 90.

5% and we expect a prescription volume to increase significantly throughout 2020 as a result.

[noise] Humira in the U.S. continues to generate strong revenue driving more than $10 billion or growth in 2019 and will remain a significant.

Maybe due to growth again in 2000 <unk> 2020.

International and get married dynamics remain consistent with our expectations with 2019 revenues down roughly 28% on an operational basis overall I'm extremely pleased with the performance and the.

Outlook for immunology franchise.

I had previously commented this guy Reggie in limbo, when deliver more than a billion dollars of revenue combined in 2020 or 2020 guidance now contemplates that these two products will contribute approximately $1.7 billion in revenue together.

Rick Gonzalez: Their successful launch trajectories demonstrate the value of these assets in two very large segments of immunology, which together represent approximately 40% of U.S. humeral revenues today. We continue to rapidly progress the development of these assets in the remaining key humeral disease areas, as well as new indications such as atopic dermatitis. Our second priority was to build our hematological oncology franchise into a major growth engine for the company. Imbruvica and Venclexta have become roughly a $5.5 billion franchise and growing rapidly.

This year.

[noise] since our inception, we have focused on building a robust pipeline and adding wrote platforms that will allow abbvie to absorb the eventual him back a biosimilar competition, U.S. and maintaining a strong and growing business we continue.

You to make excellent progress against that objective.

As I just highlighted the better than expected launch trajectory of Scott Rizzi in Windows and the continued strong performance over Hematological oncology franchise has further increased our level of confidence at these platforms will drive.

Rick Gonzalez: And we continue to expand these medicines into important new disease areas, such as multiple myeloma with Venclexta in the T1114 biomarker-defined patient population and combination therapy with Imbruvica and Venclexta, which have the potential to provide even deeper and more durable responses. The third priority was the development of a robust early and mid-stage pipeline, which now has nearly 40 clinical programs ongoing, including novel new mechanisms developed by AbbVie scientists as well as assets we are advancing across our many collaborations, such as Calico. The most advanced programs in our mid- to late-stage pipeline, which we expect to be approved by 2022, include Neviticlax for myelofibrosis. ABBV 951 for the treatment of advanced Parkinson's disease and Voliparib for the treatment of ovarian cancer and BRCA breast cancer.

If again growth over the long term.

Oh R&D productivity over the past seven years has resulted in numerous new products, which collectively contributed approximately $9 billion in revenue in 2019, and R&D pipeline continues to develop nicely with.

Multiple programs are well underway to expand the breadth of indications for Scott rizzi in remote areas.

As well is the advancement of a significant number of early and mid stage programs six of which will have proof of concept data readouts in 2020.

[noise] Cabbies R&D pipeline has been days gated from the time, we launched as an independent company back in 2013.

Our initial priority was to develop next generation assets that would be superior to humira and other competitive alternatives within our key immunology disease areas.

Rick Gonzalez: These approvals are on top of the numerous new opportunities expected for Renvo, Skyrizzy, and BenClexta. Additionally, over this same period of time, we anticipate approximately 30 proof-of-concept readouts from novel programs in our early-stage pipeline, which Mike will discuss momentarily. It is truly an exciting time for AbbVie Science. Another exciting aspect of our business is the planned acquisition of Allagan, which has significant strategic and financial merit. Allergan will provide AbbVie with highly valuable on-market assets with leadership positions across additional attractive growth segments, including new growth platforms in aesthetics and CNS neuroscience. The acquisition will further diversify AbbVie's revenue and payer mix, and immediately accelerates the standalone scale of our non-Humera business, the AbbVie growth platform, which is expected to drive high single-digit annual growth revenue over the next decade and beyond. The proposed acquisition is proceeding well. We recently received conditional approval from the European Commission. The FTC review continues to advance following the divestiture announcements for both Zempap and Allergan's IL-23, and we have completed the integration planning process, including confirmation of our synergy objectives.

And as you have seen sky resume limbo have demonstrated that type of performance across multiple clinical trials.

They're successful launch trajectory is demonstrate the value of these assets in two very large segments of immunology, which combined represent a proxy.

Similarly, 40% of U.S. Humira revenues today.

We continue to rapidly progress the development of these assets in the remaining T. humira disease areas as well as new indications such as a topic dermatitis.

Our second priority was to build our human geological.

On College, you franchise into a major growth engine for the company.

Imbruvica and Venclexta have become roughly a 5 billion dollar franchise and growing rapidly and we continue to expand these medicines into important new disease areas, such as multiple myeloma within collect stuff in the t.

In 14 biomarker defined patient population and.

In combination therapy, with Imbruvica, and Venclexta, which have the potential to provide even deeper and more durable responses.

The third priority was the development of a robust early and mid stage pipeline, which now has.

Nearly 40 clinical programs ongoing.

Including novel, New mechanisms developed by Abbvie scientists as well as assets. We are advancing across there are many collaborations such as calico.

Rick Gonzalez: We remain on track for closing the Allergan transaction as expected in the first quarter of 2020. We've entered 2020 with very strong momentum, and we're committed to delivering strong results, which is reflected in our guidance. We expect full-year 2020 adjusted earnings per share of $9.61 to $9.71, representing growth of 8.1% at the midpoint.

The most advanced programs, our mid to late stage pipeline, which we expect to be approved by two.

2022, including the Venetoclax were Milo fibrosis.

Hey, BBB 951 for the treatment of advanced Parkinson's disease, and bullet BREP for the treatment of ovarian cancer and Braca breast cancer.

These approvals are on top of the numerous new opportunities.

Rick Gonzalez: As I mentioned earlier, this guidance reflects AbbVie on a stand-alone basis. We will provide pro forma guidance for 2020 following the close of the Allergan transaction. So, in summary, as you can see from our 2019 results and our 2020 guidance, the performance of AbbVie's business remains very strong. That performance, combined with a late-stage pipeline that includes more than 20 new medicines and major new disease indications, as well as a robust early-stage pipeline, gives us significant confidence in the future outlook of our company. The AbbVie business will be even stronger and more diverse with the Allergan transaction. We look forward to another successful year and to welcoming our Allergan colleagues to the new AbbVie in the near future. With that, I'll turn the call over to Mike for additional comments on our R&D programs. Mike? Thank you, Rick.

Respected rindo sky Rizzi and things like stuff.

Over the same period of time, we anticipate approximately 30 proof of concept readouts from novel programs, our early stage pipeline, which Mike will discuss momentarily.

Is truly an exciting time for.

Abbvie science.

[noise] another exciting aspect of our business is the planned acquisition of our again, which has significant strategic and financial Merit.

Allegan will provide abbvie with highly valuable on market assets with leadership positions across additional attractive gross.

Segments, including new growth platforms aesthetics, and CNS neuroscience.

The acquisition will further diversify add these revenue and payer mix.

And immediately accelerates the standalone scale of our non Humira business, yeah, I'd be growth platform was.

Mike: When we set out as an independent company, we knew that building a productive R&D engine was an essential part of our success, and we're proud of the progress we've made over the past seven years. We built one of the strongest late-stage pipelines in our industry and brought to market six new assets, Rinvoke, Skyrizzy, Imbruvica, VanClexta, Maveritt, and Oralisa, which collectively delivered approximately $9 billion in sales in 2019. These assets are performing very well in their lead indications and will drive significant growth for AbbVie over the long term as we continue to build the body of evidence supporting their differentiated clinical profiles. In immunology, both RINBOK and SCIRISI are off to a very strong start in rheumatoid arthritis and psoriasis, respectively, and we continue to generate clinical data sets that set them apart from competitive offerings.

And to drive high single digit annual growth rather than over the next decade and beyond.

The proposed acquisition is proceeding well, we recently received conditional approval from the European Commission. The FTC review continues to advance following the divestiture announcements for Mozambique.

And now again I all 23.

And we have completed the integration planning process, including confirmation of our synergy objectives. We remain on track for closing the Allergan transaction as expected in the first quarter outweighs warning.

We've entered 2020.

With very strong momentum and we're committed to delivering strong results, which is reflected in our guidance.

We expect full year 2020, adjusted earnings per share of $9.61 and $9.71 representing growth.

Mike: For example, we recently announced positive top-line results from a Phase 3 head-to-head trial comparing Skyrizzy to Cosentyx in psoriasis. In this study, Sky RISD demonstrated superiority to Cosentix at week 52, with 87% of Sky RISD patients achieving POSI 90, compared to 57% for Cosentix. Sky Rizzi also demonstrated superiority to Cosentix on all ranked secondary endpoints, including Posse 100, Posse 75, and SPGA clear or almost clear at week 52. These results underscore two critical components of Sky RISD's profile.

They 0.1% at the midpoint.

As I mentioned earlier.

This guidance reflects add the on a standalone basis, we will provide pro forma guidance for pointing joining following the close of the Allergan transaction.

So in summary, as you can see from our 2000.

In the 19 results and our 2020 guidance the performance of bad These business remains very strong.

Net performance combined with the late stage pipeline, which includes more than 20, new medicines and major new disease indications as well as a robust early stage pipeline gives.

Significant competence in the future outlook of our company.

Mike: The ability to drive high levels of response and the durability of that response at long-term endpoints. In oncology, we will also continue to support our HEMONC franchise with important regulatory milestones and additional phase three data readouts for our approved indications in 2020. We recently received a positive CHMP opinion for Venclexta in previously untreated CLL, and we expect to receive an important label update for Imbruvica in the first half of this year based on results from the ECOG study, which demonstrated the superiority of Imbruvica to FCR in frontline fit patients with CLL. When we think about sources of growth beyond the current indications for our recently approved assets, it's important to consider two components of our late-stage pipeline. The FIRST is a large number of programs that will allow us to drive our core assets into important new disease areas that represent large and attractive markets. And the second is a set of new assets that will help support additional growth in the future.

The abbvie business will be even stronger and more diverse with the allergan transaction.

We look forward to another successful year and two welcoming our allergan colleagues to the new abbvie in the near future with that I'll turn the call over to Mike.

For additional comments on our R&D progress Mike.

[noise]. Thank you Rick.

When we set out as an independent company, we knew that building a productive R&D engine wasn't an essential part of our success. We're proud of the progress we've made over the past seven years.

We've built one of the strongest late stage pipeline in our industry.

And brought to market six new assets revoke Skype busy imbruvica and Venclexta, Navarrette and wireless which collectively delivered approximately 9 billion in sales in 2019.

These assets are performing very well in their lead indications and will drive significant growth for adding over the long term.

Her as we continue to build the body of evidence supporting their differentiated clinical profiles.

[noise] in immunology, both Rainbow can sky rizzi are off to a very strong start in rheumatoid arthritis and psoriasis respectively.

Mike: If we look first at our opportunity to move into new disease areas with our existing therapies, we see a number of commercially attractive programs that have been de-risked based on strong data. For example, we recently announced top-line results from the second phase three study for RINVOC in psoriatic arthritis, which compared RINVOC to both placebo and Humira in patients who had an inadequate response to at least one non-biologic In this study, both doses of RINVOC met all primary and key secondary endpoints, demonstrating a significant impact on both joint and skin endpoints, as well as radiographic inhibition of damage to joint structure.

We continue to generate clinical datasets that sets them apart from the competitive.

Thanks.

For example, we recently announced positive top line results from a phase three head to head trial, comparing the sky Rizzi, two cosentyx and psoriasis.

[noise] in this study sky really demonstrated superiority to Cosentyx at week 52 with.

87% of Sky Rizzi patients, achieving pasi 90, compared to 57% for Cosentyx.

Skyros. He also demonstrated superiority to cosentyx on all ranked secondary endpoints.

Including Pasi 100, Pasi, 75, and SPG, a clear or almost square at.

Mike: Rinvoke also demonstrated superiority to Chimera on ACR 20 response at week 12 with the high dose and non-inferiority with the low dose. These data follow positive results from our first registrational trial, reported late last year. Detailed data from both pivotal studies will be presented at an upcoming medical meeting, and we expect to submit our regulatory applications for RINVOC and psoriatic arthritis in the second quarter, with commercialization expected in 2021. Following discussions with global regulators, our approval submissions for ankylosing spondylitis are planned for the second half of 2020, based on positive data already presented at ACR last November. In this study, RINVOKE demonstrated significantly greater improvements in signs and symptoms, as well as physical function and imaging endpoints, compared to placebo. Together, psoriatic arthritis and ankylosing spondylitis make up an important segment of the rheumatology market, with global market sales of approximately $14 billion. The dermatology segment will also be an important area of growth for RINPO.

Week 52.

These results underscore two critical components subscribers these profile.

The ability to drive high levels of response and the durability of that response at long term endpoints.

In oncology, we will also continue to support our Hmong franchise within.

Important regulatory milestones and additional phase three data readouts for our approved indications and 2020.

We recently received a positive CHF <unk> opinion for Venclexta and previously untreated CLL and.

We expect to receive an important label update for Imbruvica in the first half of this year based on results from the.

He Cogs study, which demonstrated the superiority of imbruvica to fcr and frontline fit patients with CLL.

When we think about sources of growth beyond the current indications for our recently approved assets. It's important to consider two components of our late stage pipeline.

The first as a large number of programs that will allow us to drive our core assets into important new disease areas that represent large and attractive markets.

And the second is a set of new assets that will help support additional growth in the future.

Mike: Moderate to severe atopic dermatitis is a large market that we do not participate in today, and in the middle of this year, we expect to see phase three data for RINVOC in this indication. In our Phase 2B study, RINVOKE demonstrated a very strong effect on the easy composite endpoint and had a prominent impact on itch, which is one of the most troublesome symptoms of this disease. Following the pivotal data readouts, we plan to submit global regulatory submissions later this year.

If we look first at our opportunity to move into.

New disease areas with our existing therapies, we see a number of commercially attractive programs that have been de risk based on strong data.

For example, we recently announced topline results from the second Phase three study for rent vote in Psoriatic arthritis, which compare green folks to both placebo and Humira.

In patients who had an inadequate response to at least one non biologic DMR.

And this study both doses of invoke met all primary and key secondary endpoints demonstrating significant impact on both joint and skin endpoints as well as radiographic inhibition of damage to join structure.

Mike: We are also nearing completion of the registrational programs for SCIRIS-E in several new disease areas. In the second half of this year, we expect to see data from phase 3 studies in both psoriatic arthritis and Crohn's disease, with regulatory submissions for both indications expected in 2021. The IBD segment, including both Crohn's disease and ulcerative colitis, represents a significant opportunity with global market sales of approximately $18 billion. IBD is a growing segment where there continues to be significant unmet need, and, based on the efficacy demonstrated in our mid-stage studies, we believe both SCIRIS-E and RINVOC have the potential to drive higher levels of performance than other therapeutic alternatives. Together, we expect Skyrizia and RINVO to have full coverage across the major disease areas for which Humira is currently approved, plus new areas such as atopic dermatitis. With these two new medicines, AbbVie is well positioned to maintain its strong leadership in the $70 billion global immunology market. Another growth asset that we expect to expand into important new areas is Venklexta.

Rainbow also demonstrated superiority to Humira on HCR 20 response at week 12, with the high dose and Noninferiority with the low dose.

These data follow the positive results from our first Registrational trial reported late last year.

Detailed data from both the pivotal studies will be presented.

An upcoming medical meeting and we expect to submit our regulatory applications for rentals and Soriana arthritis in the second quarter with commercialization expected in 2021.

Following discussions with global regulators are approval submissions in the ankle listing spondylitis our plan for the second half of.

Many 20 based on positive data already presented at HCR last November.

And this study rent bump demonstrated significantly greater improvements in signs and symptoms as well as physical function and imaging endpoints compared to placebo.

[noise] together Psoriatic arthritis.

That's an ankle hosting spondylitis makeup and important segment of the rheumatology market with global market sales of approximately $14 billion.

Mike: Canova, our phase 3 study in relapsed refractory multiple myeloma patients with the T1114 genetic mutation, is now well underway, and towards the end of this year, we plan to initiate a second phase 3 study in the relapsed refractory T1114 population. VanClexta has the potential to become an important biomarker-driven treatment option in multiple myeloma. The transformed cells in T11-14 patients have a B-cell-like phenotype and express high levels of Bcl-2.

The dermatology segment will also be an important area of growth for invoke.

Moderate to severe a topic dermatitis, it's a large.

We do not participating today.

And in the middle of this year, we expect to see phase three data for rent bulk in this indication.

And our phase Twob study when both demonstrated a very strong effect on the easy.

Composite endpoint and had a prominent impact on hedge which is one of the most.

Mike: We've seen very promising results in this population, in early and mid-stage trials, with Venclexta showing high overall response rates and prolonged progression pre-survival. The level of efficacy that we've seen suggests that T11-14 patients may be particularly responsive to venclexin. This biomarker-defined population makes up approximately 20% of the $18 billion multiple myeloma market, representing an important new opportunity for Venclexta. In addition to multiple myeloma, we will begin Phase 3 studies in two additional BCL-2 driven diseases in 2020. The first is AML.

Some symptoms of this disease.

Following the pivotal data read outs, we plan to submit global regulatory submissions later this year.

We're also nearing completion of the Registrational programs for Sky Rizzi, and several several new disease areas.

And the second half of this.

This year, we expect to see data from phase three studies in both Psoriatic arthritis, and Crohns disease with regulatory submissions for both indications expected in 2021.

[noise], the IB de segment, including both Crohns disease, and ulcerative colitis represents a significant opportunity with.

Mobile market sales approximately $18 billion.

Mike: Building on our experience in the transplant ineligible population, we are initiating a study in fit patients with AML who have received a stem cell transplant but remain at high risk for recurrence. The second is higher-risk myelodysplastic syndrome or MDS. MDS is a malignant disease of bone marrow stem cells that is associated with significant morbidity and mortality due to the risk of bleeding, infection, and transformation to acute leukemia. Some patients with MDS undergo a stem cell transplant, but many cannot. And these patients have very few treatment options.

I'd is a growing segment, where there continues to be significant unmet need and.

Based on the efficacy demonstrated in our mid stage studies, we believe both Sky Rizzi, Andrew invoke have the potential to drive higher levels of performance than other therapeutic.

Turn it is.

Together, we expect sky resin resolved to have full coverage across the major disease areas for which Humira is currently approved plus new areas such as a topic dermatitis.

With these two new medicines, Abby is well positioned to maintain its strong leadership in the.

70 billion dollar local immunology market.

Mike: Preclinical and early clinical studies support a role for BCL-2 inhibition in these patients, and our phase three studies with Venclexta will begin later this year. The second component of value in our late-stage pipeline includes important new therapies that we expect to launch in 2021 and 2022, including Nividoclax, Voliparib, and ABBV951. Nebidoclax will be entering phase 3 studies in the first half of this year in front line and second line myelofibrosis. Myelofibrosis is a malignant disease in which the bone marrow is replaced with fibrotic tissue, leading to bone marrow failure.

Another growth asset that we expect to expand into important new areas Venclexta.

Canova, our phase three study in relapsed refractory multiple myeloma patients with a t. 11, 14 genetic mutation is now well under way.

And towards the end of this year, we plan to initiate a second phase three study and the relapse refractory CLL and 14 population.

Thanks, Flextor has the potential to become an important biomarker driven treatment option in multiple myeloma.

The transform sells into 11 14 patients at the B.

Well like phenotype and expressed high levels of Bcl two.

We've seen very promising results in this population in early and mid stage trials with things like still showing high overall response rate and prolongs progression free survival.

Mike: Currently, JAK2 inhibition is the only approved therapeutic option. However, despite treatment, many patients progress and experience significant morbidity and mortality. Nividoclax is a first-in-class BCLXL inhibitor with the potential to transform the treatment of myelofibrosis by deleting the clone that causes the disease. At ASH last year, we presented encouraging data from a Phase II study that demonstrated that up to 43% of patients who had failed JAK2 inhibition responded to Novitaclax based on a 35% reduction in spleen volume. In addition, responses deepened over time, and we continue to follow these patients.

The level of up to see that we've seen suggests that T 11, 14 patients maybe.

Fairly responsive to Venclexta.

This biomarker defined population makes up approximately 20% of the $18 billion multiple myeloma market revpas, representing an important new opportunity for Venclexta.

In addition to multiple myeloma, we will begin phase three studies.

In two additional bcl two driven diseases in 2020.

The first is AML.

Building on our experience in the transplant eligible population we are initiating a study in patients with an now who have received stem cell transplant, but remain at high risk for recurrence.

Mike: Nevidoclax-treated patients also showed reductions in the number of malignant cells and decreases in bone marrow fibrosis, supporting the potential for disease modification. In the area of solid tumors, we previously presented positive phase 3 data from two veliparib studies in front-line ovarian cancer and BRCA breast cancer. Data from these two studies demonstrated significant prolongation of progression-free survival and support the use of PARP inhibition in combination with chemotherapy earlier in the course of treatment. In ovarian cancer, Bolivarab will be the only PARP inhibitor to combine with front-line chemotherapy and treat a broader population that is not restricted to biomarker status or chemo-responsiveness. In BRCA-positive breast cancer, Bolivarib will also be the only PARP inhibitor to combine with platinum-based chemotherapy, giving these patients a valuable new treatment option. Based on feedback from global regulatory authorities, we plan to submit our applications for BulletBridge in the first half of this year.

The.

Second is higher risk myelodysplastic syndrome or Mds.

Mds is a malignant disease, a bone marrow stem cells that is associated with significant morbidity and mortality due to the risk of bleeding infection and transformation to acute leukemia.

[noise] some patients with MD.

Yes undergo stem cell transplant, but many cannot and these patients had very few treatment options.

Preclinical and early clinical studies support a role for Bcl two inhibition in these patients and our phase three studies with Venclexta will again later this year.

[noise].

The second component of value in our late stage pipeline includes important new therapies that we expect to launch in 2021, and 2022, including the bid a class deliberate and Abbvie nine five want.

Net debt of KLAX will be entering phase three studies in the first half of this year.

In frontline and second line myelofibrosis.

Mike: Bolivar will be an important new treatment option for women with ovarian cancer and brachybreast cancer, offering the potential to provide better outcomes. And in our late-stage neuroscience pipeline, we are making good progress with the Phase III program for ABBV951, our innovative approach to delivering DUOPA-like efficacy to our subcutaneous delivery system for advanced Parkinson's disease. This approach is enabled by novel levodopa and carbidopa prodrugs and would be a transformative improvement to current treatment options. With a less invasive non-surgical delivery system, 951 has the potential to significantly expand the patient population currently addressed by DUOPA or other more invasive therapies for advanced Parkinson's, such as deep brain stimulation.

Myelofibrosis malignant disease in which the bone marrow is replaced with fiber optic tissue leading to bone marrow failure.

Currently Jack to inhibition is the only approved therapeutic option.

But despite treatment many patients progress and.

Significant morbidity and mortality.

The Middle class is a first in class Bcl XL inhibitor with the potential to transform the treatment of myelofibrosis buys a leading the clone that causes the disease.

At Ash last year, we presented encouraging data from the phase two.

Study, which demonstrated that up to 43% of patients with sales Jack to inhibition responded to that of KLAX based on that 35% reduction in spleen volume.

In addition responses deepened overtime and we continue to follow these patients.

Mike: We'll see data from the Pivotal program in 2021, with commercialization anticipated in 2022. In addition to advancing our late-stage programs, we've also made tremendous progress building our early-stage pipeline. Following several years of investment, we're beginning to see these efforts pay off.

In the Middle class treated patients also showed.

Actions in the number of malignant cells and decreases in bone marrow fibrosis supporting the potential for disease modification.

In the area of solid tumors. We previously presented positive phase three data from two different studies in frontline ovarian cancer and bracket breast cancer.

Mike: And over the next three years, we're planning for proof-of-concept data readouts in approximately 30 programs. Our early pipeline is designed to include a mix of highly novel targets supported by strong underlying science and clinically validated targets where we think an opportunity exists to improve on current agents. In the area of immunology, I'll highlight our TNF steroid conjugate, ABBV3373, which is a novel technology that delivers a proprietary, high-potency steroid directly to activated immune cells by TNF-mediated uptake. We've shown in model systems that this approach has the potential to drive transformational, and early clinical work has demonstrated that we can deliver 3,3,7,3 at its anticipated therapeutic dose without systemic We will see efficacy data from this study later this year.

Data from these two studies demonstrated significant prolongation of progression free survival and support the use of PARP inhibition in combination with chemotherapy earlier in the course of treatment.

In ovarian cancer deliverable will be the only PARP inhibitor to combine with frontline.

You know therapy and treat a broader population that is not restricted to biomarker status or chemo responsiveness.

In Braca positive breast cancer Bulletproof will also be the only PARP inhibitor to combine with platinum based chemotherapy, giving these patients of valuable new treatment option.

Based on feedback.

Back from global regulatory authorities, we plan to submit our applications for bullet breadth in the first half of this year.

Well, let rik will be an important new treatment option for women with ovarian cancer and braca breast cancer offering the potential to provide better outcomes.

Mike: If our clinical data reproduce what we have seen preclinically, our steroid conjugate technology has the potential to serve as a platform across a wide range of diseases, including RA, IBD, and lupus. We will also see proof-of-concept data this year from several other early-stage assets in our immunology portfolio, including data for ABBV-599, our JAK-BTK program, and ABBV-323, our CD40 antagonist program, which are both targeting multiple pathogenic nodes that are thought to play important roles in diseases such as RA, IBD, lupus, and scleroderma, allowing us to rest In oncology, we are building on what we have learned with venetoclax and nebitoclax to advance a number of promising apoptosis programs.

And in our late stage neuroscience pipeline we are.

Making good progress with the phase three program for HBV 951, our innovative approach to delivering to open like efficacy towards subcutaneous delivery system for advanced Parkinson's disease.

This approach has enabled by novel lever dopa and carbon Carbidopa pro drugs and would be a transformative improvement.

To current treatment options.

With a less invasive nonsurgical delivery system nine fiberlan has the potential to significantly expand the patient population currently addressed by Duodopa or other more invasive therapies for advanced Parkinson's such as deep brain stimulation.

We'll see.

See data from the pivotal program in 2021 with commercialization anticipated in 2022.

In addition to advancing our late stage programs. We've also made tremendous progress building our early stage pipeline.

Following several years of investment we're beginning to see these efforts pay.

Mike: The most advanced of these are ABBV155, which uses a B7H3 targeting antibody to deliver a novel, high-potency BCLXL warhead to solid tumors, and ABBV621, which is designed to induce apoptosis by clustering a trail and apoptosis-inducing ligand on the surface of cancer cells. We will see monotherapy data for ABBV 155 in 2020 We expect to see proof of concept data for ABBV 621 in 2021 as well. ImmunoOncologist, We have a number of very promising T-cell redirecting specifics in the clinic and several more in preclinical development.

And over the next three years, we're planning for proof of concept data read outs and approximately 30 programs.

Our early pipeline is designed to include a mix of highly novel targets supported by strong underlying science and clinically validated targets, where we think an opportunity exists to.

Proof on current agents.

In the area the immunology I'll highlight our TNF steroids conjugate HBV Threethree seven three which is novel technology that delivers a proprietary high potency steroids directly to activated immune cells by TNF mediated uptake.

We've shown any model systems that this approach has the potential to drive transformational efficacy and our early clinical work has demonstrated that we can deliver 3373 and its anticipated therapeutic dose without systemic steroids effects.

Mike: The most advanced of these are BCMA bispecifics in multiple myeloma, PNB338B and HPN217. These programs allow us to explore different epitope specificities and binding affinities to optimize benefit-risk of our candidates in this very promising area. We are also pursuing several novel approaches designed to modify the tumor immunosuppressive environment.

We will see efficacy data from this study later this year.

If our clinical data reproduce what we've seen preclinically, our steroids conjugate technology has the potential to serve as a platform across a wide range of diseases, including our AG Ivy D and lupus.

Mike: Here, I would highlight ABBV 151, our monoclonal antibody targeting GARP. Through its effect on GARP, ABBV151 reduces TGF-beta-mediated signaling within tumors. TGF-beta signaling is thought to be an important driver of tumor immune evasion, and TGF-beta signaling is correlated with a lack of tumor immune infiltrate and PD-1 unresponsiveness

We will also see proof of concept data this year from several.

Other early stage assets in our immunology portfolio.

Including data for HBV 599, our Jack BTK program and Abbvie three to three RCD 40 antagonist program.

Which are both targeting multiple pathogenic nodes that are thought to play important roles and diseases, such as our AG IB.

Lupus and scleroderma.

Mike: In addition, I would highlight our CD39 inhibitor, TTX030. Recently, emerging data suggest that CD39 plays an important role in tumor immune evasion by converting pro-inflammatory ATP to anti-inflammatory ADP and adenosine in the extracellular environment. TTX030 is designed to restore this important pro-inflammatory signal and reduce tumor immunosuppression. Lastly, in our early neuroscience pipeline, we have several promising disease-modifying candidates in the clinic for Alzheimer's and Parkinson's. In addition to our Cal-directed programs, we have programs aimed at important regulators of the neuroinflammatory response, TREM-2 and CD33, as well as a core driver of pathology in Parkinson's.

Allowing us to restate standard of care and our core disease areas and move into new ones, where no effect effective therapy exist today.

In oncology, we are building on what we have learned within added clocks and the Vidic KLAX to advance a number of promising a pop.

Doses programs.

The most advanced of these are a BBB 155, which uses a b seven age three targeting antibody to deliver a novel high potency Bcl XL warhead to solid tumors.

And ADB six to one which is designed to induce apoptosis by clustering.

Well and apoptosis inducing ligand on the surface of cancer cells.

We will see monotherapy data for a BBB 155 in 2020 and combination data in 2021.

Mike: Alpha Synuclein, So, in summary, we've continued to see significant evolution of our early and late-stage development programs. We have a late-stage pipeline that includes more than 20 programs in registrational studies and have nearly 40 programs in early to mid-stage development that will mature over the next few years. With that, I'll turn the call over to Rob for additional comments on our 2019 performance and our 2020 guidance.

We expect to see proof of concept data for ABB six to one in 2021 as well.

In immuno oncology, we have a number of very promising T cell redirecting bi specifics in the clinic and several more in preclinical development.

Most advanced disease, RBC I'm, a bi specifics in multiple myeloma.

Dnbi, three 380, and HP N 217.

Rob: Thank you, Mike. Today, I'll review our performance for the fourth quarter and full year 2019, and then walk through our 2020 outlook. We had another year of strong execution. We reported adjusted earnings per share of eight dollars and ninety four cents, reflecting growth of 13 percent compared to the prior year and beating our initial guidance midpoint by 24 cents. For the full year, net revenues were $33.3 billion, up 2.7% on an operational basis, excluding a 1.1% unfavorable impact from foreign exchange. Strong growth from several key products and newly launched assets more than offset the impact of international biosimilar competition.

These programs allow us to explore different epitope specificities and binding affinity to optimize benefit risk of our candidates in this very promising area.

We're also pursuing several novel approaches designed to modify the tumor immunosuppressive environment.

Here I would highlight.

ABVD Onefive, one our monoclonal antibody targeting GARP.

So its effect on GARP HDTV 151, it reduces TGF beta mediated signaling within tumors.

TGF beta is thought to be an important driver of tumor immune evasion and TGF beta signaling is correlated.

Got it with a lack of tumor immune infiltrate and PD one on responsiveness.

In addition, I would highlight our CD 39 inhibitor TTX zero three zero.

Rob: For the fourth quarter, net revenues were $8.7 billion, up 5.3% on an operational basis, excluding a 0.5% unfavorable impact from foreign exchange. U.S. Humira sales were $4 billion, up 9.8% compared to the prior year, reflecting high single-digit volume growth plus price. Wholesaler inventory levels remained below half a month in the quarter.

Recently emerging data suggest that CD 39 plays an important role in tumor immune evasion by converting proinflammatory.

<unk> to anti inflammatory ATP and adenosine in the extra cellular environment.

TTX zero three zero is designed to restore this important pro inflammatory signal and reduce tumor immuno suppression.

Rob: Full year sales of Humira in the U.S. were $14.9 billion, up 8.6% versus the prior year. International Humerus sales were approximately $950 million in the quarter, down 25.4% operationally, reflecting biosimilar competition across Europe and other international markets and in line with our expectations. Sky Rizzi continues to perform extremely well, with global sales of $216 million in the quarter.

Lastly, and our early neuroscience pipeline, we have several promising disease.

Fine candidates in the clinic for Alzheimer's and Parkinson's disease.

In addition to our town directed programs, we have programs aimed at important regulators of the narrow inflammatory response trend to and Cdthirty three as well as a core driver pathology in Parkinson's disease Alpha Synuclein.

So in summary, we've continued to see significant evolution of our early and late stage development programs. We have a late stage pipeline that includes more than 20 programs in Registrational studies and have nearly 40 programs in early to mid stage development that will mature over the next few years.

Rob: Ren Voke is also demonstrating strong uptake, with sales of $33 million in the first full quarter following the U.S. launch in late August. For the full year, the combined revenues of Sky RISD and RINVOC were $402 million, above our initial expectation. Hematologic Oncology Global Sales were more than $1.5 billion in the quarter, up 37.2% on an operational basis, driven by the continued strong performance of both Imbruvica and Venclexta, and Bhruvika Global Net Revenues were approximately $1.3 billion in the quarter, up 28.9% driven by strong share in all lines of therapy and CLL. Bank Collector revenues were $251 million in the quarter, driven by continued share gains across all approved indications.

With that I'll turn the call.

Over to Rob for additional comments on our 2019 performance and our 2020 guidance Rob. Thank you Mike Today I'll review, our performance for the fourth quarter and full year 2019, and then walk through our 2020 outlook.

We had another year of strong execution.

We reported adjusted earnings per share.

Sure of $8, a 94 cents, reflecting growth of 13% compared to prior year and beating our initial guidance midpoint by 24 cents.

For the full year net revenues were $33.3 billion up 2.7% on an operational basis, excluding a 1.1.

Percent unfavorable impact from foreign exchange strong growth from several key products and newly launched assets more than offset the impact of international Biosimilar competition.

Rob: For the full year, our HEMA global revenues were $5.5 billion, up 39.3% on an operational basis. Global HCV sales were $632 million in the quarter. For the full year, HCV sales were $2.9 billion, down 17.7% on an operational basis, driven by lower treated patient volumes in select international markets and increased competition within the U.S.-managed Medicaid segment.

For the fourth quarter net revenues were $8.7 billion up 5.3% on operational basis excluding.

Being a 0.5% unfavorable impact from foreign exchange.

Yes, Humira sales were $4 billion up 9.8% compare to prior year, reflecting high single digit volume growth plus price.

Rob: We also saw continued strong operational sales growth for Creon and Duodopa. Turning now to the P&L profile for the fourth quarter, adjusted gross margin was 81.6 percent of sales, up 180 basis points compared to the prior year, including the year-over-year benefit related to the expiration of Humira royalties. Adjusted R&D investment was 15.3% of sales, supporting our pipeline programs in oncology, immunology, and other areas. Adjusted SG&A expense was 21.6% of sales, reflecting continued investment in our on-market products and newly launched assets. The adjusted operating margin ratio was 44.6% of sales, an improvement of 290 basis points versus the prior year. Adjusted net interest expense was $282 million, and the adjusted tax rate was 8.8%.

Wholesaler inventory levels remain below half a month in the quarter.

Full year sales of.

Humira and U.S. were $14.9 billion up 8.6% versus prior year.

[noise] International Humira sales were approximately $950 million in the quarter down, 25.4% operationally, reflecting biosimilar competition across Europe and other international.

In markets and in line with our expectations.

Sky Rizzi continues to perform extremely well with global sales of $260 million in the quarter.

RIN bulk is also demonstrating strong uptake with sales of $33 million in the first full quarter following the U.S. launch in.

Late August.

For the full year, the combined revenues of Sky Rizzi, and Renvela were $402 million and above our initial expectations.

Rob: Fourth quarter adjusted earnings per share, excluding specified items, was $2.21, up 16.3% versus the prior year. As we look ahead to 2020, our fully-adjusted earnings-per-share guidance is between $9.61 to $9.71, reflecting growth of 8.1% at the midpoint. Excluded from this guidance is $1.95 of known intangible amortization and specified items.

Hematologic oncology global sales were more than $1.5 billion in the quarter up 37.2% on an operational basis.

Driven by the continued strong performance of both Imbruvica and Venclexta.

Imbruvica Global net revenues were approximately $1.3 billion in the quarter up 28.9% driven by strong share and all lines of therapy in CLL.

Cluster revenues were 200.

The $1 million in the quarter driven by continued share gains across all approved indications.

Rob: On the top line, in 2020, we expect revenue growth approaching 8% on an operational basis. At current rates, we expect foreign exchange to have a minimal impact on reported sales growth. This forecast includes the following assumptions for a key product. In 2020, we expect US Humira to deliver revenue growth of approximately 9%. We expect International Humira sales to approach $3.4 billion at current exchange rates. Additionally, as Rick noted, we expect global sales of our newly launched immunology products to reach approximately $1.7 billion in 2020. This includes Skyrizzy global revenues of approximately $1.2 billion, and Renvo global revenues of approximately $500 million.

For the full year, our HMI global revenues were $5.5 billion up 39.3% on operational basis.

Global HCV sales were $632 million in the quarter for.

The full year HCV sales were $2.9 billion down 17.7% on an operational basis, driven by lower treated patient volumes and select international markets and increased competition within the U.S. managed Medicaid segment.

We also saw continued strong operational sales growth.

Our creon and Duodopa.

Turning now to the piano profile for the fourth quarter. Adjusted gross margin was 81.6% of sales up 180 basis points compared to the prior year, including the year over year benefit related to the exploration Acumera royalties.

Rob: We expect our HEMOC franchise to grow 24% on an operational basis, with Imbruvica Global revenues of approximately $5.5 billion and VanCleck's Global Sales of approximately $1.3 billion. We expect HCV global sales of approximately $2.5 billion. For Creon, we expect revenue growth of approximately 10%. For Duodopa, we expect sales of approximately $500 million. For Lupron, Synthroid, and Synergis, we expect sales to be roughly flat year over year.

Adjusted.

R&D investment was 15.3% of sales supporting our pipeline programs on oncology immunology and other areas.

Adjusted <unk> expense was 21.6% of sales, reflecting continued investment in our on market products and newly launched assets.

The adjusted operating margin ratio was.

44.6% of sales and improvement of 290 basis points versus the prior year.

Adjusted net interest expense was $282 million and the adjusted tax rate was 8.8%.

Rob: And we expect approximately $200 million in combined revenue from oralisa and endometriosis, elegolics, and uterine fibroids. Looking at the P&L for 2020, we are forecasting an adjusted gross margin of approximately 81.5% of sales. We are forecasting adjusted R&D expense just above 14% of sales, reflecting continued investment across all stages of our pipeline. We are forecasting adjusted SG&A expense to be just above 19% of sales, including funding to maximize the sales potential of new products. We are forecasting an adjusted operating margin ratio of approximately 48% of sales, an improvement of roughly 70 basis points versus 2019. We expect adjusted net interest expense of approximately $1.2 billion, and we model a non-gap tax rate of approximately 10%. Finally, our share count for 2020 will be roughly flat. Regarding our first quarter outlook, we expect adjusted earnings per share between $2.28 and $2.30, excluding approximately $0.53 of known intangible amortization and specified items. We anticipate first-quarter operational sales growth of approximately 7%. Additionally, at current rates, we expect a modest, unfavorable foreign exchange impact.

Fourth quarter adjusted earnings per share excluding specified items was $2.21.

Up 16.3% versus prior year.

[noise] [noise] as we look ahead to 2020, our full year adjusted earnings per share guidance as between $9.61 to $9.71, reflecting growth of 8.1% at the midpoint.

[noise] excluded from this guidance is $1.95 cents of known intangible amortization and specified items.

On the topline in 2020, we expect revenue growth approaching 8% operational basis at current rates, we expect foreign exchange had a minimal impact on reported sales growth.

This forecast comprehends the following assumptions for our key products in 2020, we expect us jumeirah to deliver revenue growth of approximately 9%.

We expect international Humira to approached $3.4 billion at current exchange rates.

As Rick noted, we expect global sales of our.

Early launch immunology products to reach approximately $1.7 billion in 2020.

This includes Sky Rizzi global revenues of approximately $1.2 billion and RIN, both global revenues of approximately $500 million.

Rob: For US Humira, we expect sales of approximately $3.5 billion. We expect international HUMEIRA sales of approximately $900 million, assuming current exchange rates. For Sky RISD, we expect global sales of approximately $250 million, and for Forum Bruvica, we expect global sales approaching $1.2 billion. Moving now to the P&L for the first quarter, we are forecasting an adjusted operating margin ratio of approximately 48.5% of sales. As a reminder, the 2020 guidance provided today reflects AbbVie on a standalone basis. We will provide combined AbbVie and Allergan guidance after the close of the transaction. In closing, AbbVie has once again delivered outstanding results, and with our strong track record, combined with the momentum of our business, we are well positioned for strong growth in 2020. With that, I'll turn the call back over to Liz. Thanks, Rob. We will now open the call for questions. Operator, first question, please. And as a reminder, if you would like to ask a question, please press star 1. Our first question today is from Jeffrey Porges from SVB Lear, Inc.

We expect our hemlock franchise to grow 24% on.

Well basis.

Imbruvica global revenues of approximately $5.5 billion and Venclexta global sales of approximately $1.3 billion.

We expect HCV global sales of approximately $2.5 billion.

For a Korean we expect revenue growth of approximately 10%.

Or duodopa, we expect sales of approximately $500 million.

For Lupron, Synthroid and Synagis, we expect sales to be roughly flat year over year.

And we expect approximately $200 million in combined revenue from oral lessor in endometriosis and Elagolix in uterine fibroids.

So looking at the piano for 2020, we are forecasting adjusted gross margin of approximately 81.5% of sales.

We are forecasting adjusted R&D expense, just about 14% of sales, reflecting continued investment across all stages of our pipeline.

We are forecasting adjusted EPS generics.

Tends to be just above 19% of sales, including funding to maximize the sales potential of new products.

Rick Gonzalez: Thank you very much for the question and congratulations on the quarter. Rick, I just want to ask you, it's been a while since you gave the kind of initial overview of the basis for the Allagan transaction.

We are forecasting an adjusted operating margin ratio of approximately 48% of sales and improvement of roughly 70 basis points versus 2019.

We expect adjusted net interest expense.

Rick Gonzalez: Could you talk about how the business performance of AbbVie and, frankly, also Allagan has been trending compared to the assumptions that you had going into the transaction? And then, as you get close to closing, how confident are you about the two billion in synergies and how soon they might be? Hey Geoff, um... You know, I think you've obviously seen the stand-alone AbbVie performance, and we're coming off of another very good year, and our projection, our guidance, obviously, is projected from a stand-alone basis. Another strong year for the company, and I think, in particular, we're very impressed with what we're seeing out of our immunology franchise and what we're seeing out of our We've been watching the Allergan performance.

<unk> of approximately $1.2 billion, and we model and non-GAAP tax rate of approximately 10%.

Finally, our share count for 2020 will be roughly flat.

Regarding our first quarter outlook, we expect adjusted earnings per share between $2.28.

Sense and $2.30, excluding approximately 53 cents of known intangible amortization and specified items.

We anticipate first quarter operational sales growth of approximately 7% at current rates, we expect a modest unfavorable foreign exchange impacts.

For U.S. Humira.

We expect sales of approximately $3.5 billion.

We expect international Humira sales of approximately $900 million, assuming current exchange rates.

Rick Gonzalez: They've reported two quarters that we've seen. They'll be reporting another quarter here soon, probably sometime early next week, and I would say, at least for the two that have been reported, overall, the business is tracking, I'd say, slightly ahead of what our deal model had projected. As I mentioned a number of times, our deal model that we put together was a fairly conservative deal model, so that's not too surprising, but I think as you look at the key products that are, you know, critical products for their business, they're all performing in line or ahead of what our projections were. As it relates to synergies, as I mentioned in my formal comments, we have gone through the entire integration planning process with Allergan.

For Sky ready, we expect global sales of approximately $250 million.

And for Rubicon, we expect global sales approaching 1.2 billion.

Dollars.

Yes.

Moving now the piano for the first quarter, we are forecasting an adjusted operating margin ratio of approximately 48.5% of sales.

As a reminder, the 2020 guidance provided today reflect abbvie on a standalone basis, we will provide.

Combined abbvie and Allergan guidance after the close of the transaction.

In closing Abbvie has once again delivered outstanding results and with our strong track record combined with the momentum of our business, we are well positioned for strong growth in 2020.

Rick Gonzalez: Part of that process is to validate the synergies, and so we're comfortable that the synergy target that we had communicated, which was $2 billion or greater than $2 billion, is an achievable number. Obviously, any time you do a transaction like this, you're trying to maximize the synergies and obviously maintain the business to perform at the level that you would expect it to perform, so I feel good about the synergies projection We'll provide final gatekeeping for those projections when we do the combined pro forma guidance, but I feel good about the overall target over the first three years meeting or exceeding what we had projected. The timing closed, everything is progressing as we had planned, and we still anticipate that we will see closure by the end of the first quarter.

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

Thanks, Rob we will now open the call for questions Operator first question.

And as a reminder, if he would like to ask a question. Please press star one our first question today is from Jefferies purchase from SPP Leerink.

Thank you very much for the question congratulations on the quarter.

Rick I just wanted to ask you.

While since since you guys kind of initial overview of of the basis for the Oregon transaction could you talk about how the business performance of Abbvie and frankly also allegan has been trending.

Compared to the assumptions that you had going into the transaction and then as you get close to closing how confident you about.

The 2 billion in synergies and how soon might they be realized thanks.

Hey, Jeff.

Yes, I think you've obviously seen the standalone abbvie performance and we're coming off of another very good year and our projection our guidance, obviously is projecting from a standalone basis.

Rick Gonzalez: The other thing I'd say is, as we step back and we look at what we were trying to accomplish with the Allergan transaction, it was basically to try to build a business that, over the long term, would be even stronger than the AbbVie business. Over the long term, and I think one of the things as investors start to think about the business, it's important to sort of put that in perspective. We want a business that's more diversified, both from a revenue standpoint as well as from a payer mix standpoint. We want a business that has durable positions. You know, this business, the combined business, will have durable growth positions in eight different franchises and be able to drive strong growth. There will be four franchises for the new company that will be the major growth franchises for us. Obviously, immunology, hematology, oncology, medical aesthetics, and CNS Neuro will be the four franchises.

Another strong year for their company a in particular were very impressed with what we're seeing over immunology franchise in what we're seeing out of our human franchise and so we feel good we've been watching the allergy and performance.

For the two quarters that we've seen there will be reporting another quarter here soon.

Probably sometime early next week.

I would say at least for the two that had been reported.

Overall, the business is tracking I'd say slightly ahead of what our deal model had projected as I mentioned I think a number of time their deal model that we put together was a fairly conservative deal model.

So that's not too surprising but are they going to look at the key products that are critical products for their business.

There are all performing in line or ahead of what our projections were as it relates to the synergies as I mentioned in my formal comments, we have gone through all of the.

Rick Gonzalez: This is a business that will have excellent payer diversity and payer mix. If you look at it as a percent of the global revenues, Medicare Part B will be about 2%. Medicare Part D will be about 16%. Medicaid will be about 3%. And cash pay will be about 10%. So, nice balance and security along the payer base. It'll be a business that's driven by volume, not by price. And so that's important.

And planning process with Allergan.

Part of that process is to validate the synergies and so we're comfortable that the synergy target that we had communicated which was $2 billion are greater than $2 billion.

Isn't achievable number obviously.

Yes, I mean do a transaction like this you're trying to maximize the synergies.

Rick Gonzalez: It'll be a company that has a strong growing dividend that's underpinned by tremendous cash flow, which provides security to deliver a growing dividend over the long term and through the loss of exclusivity in 2023 in the U.S. It'll also have a number of recently launched products and growth products. In fact, there'll be six of them, if you think about it.

And obviously maintain the business to perform at the level that you would expect it to perform so I feel good about the synergy projections will provide the final gating for those projections when we do the combined pro forma guidance.

And but I feel good about the overall the overall target.

Over the first three years meeting or exceeding what we had projected the timing close everything is progressing as we had planned.

Rick Gonzalez: You look at Skyrizzy, Renvo, Benclexta, and Bruvica. Those all have significant growth opportunities ahead of them on the AbbVie side. And then you look at the Allergan side. You have Valarm.

And we still anticipate that we will see closure by the end of the.

Rick Gonzalez: This is a product that has a, it's about an $850 million product. I think the last numbers I saw showed it was growing about 70%. And you have their recently launched OralCGRP that we haven't seen any data on yet, as far as their revenue performance is concerned because they just launched it. But I think that will be an important product over the long term. So, and then that's underpinned by our late-stage pipeline that has, you know, 20 new drugs and new major indications, and an early-stage pipeline that Mike outlined in his remarks. That's a pretty impressive profile of a company in our industry, and that's the kind of company we were trying to build by combining these two companies together. So, I think that's how we think about it. Right? Thanks very much.

Of the first quarter.

Thing I'd say is as we step back and when you look at what will we tried to accomplish with the Allergan transaction.

It was basically to try to build a business that ultimately would be even stronger than the abbvie business over the long term and I think one of the things as as in.

Best through start to think about the business, it's important to sort of put that in perspective, we want to businesses more diversified.

Both from a revenue standpoint, as well as a payer mix standpoint, we weren't business. It has durable positions you know this business. The combined business will have durable growth positions in a different.

As is and be able to drive strong growth there will be four franchises for the new company that will be the major growth franchises for us obviously in immunology Hematological oncology.

Rick Gonzalez: Thanks, Jeffrey. Operator, next question, please. Thank you. Our next question is from Steve Scala from Cohen.

Medical aesthetics, and and CNS neuro will be the four franchises. This is a business that will have excellent.

Rick Gonzalez: Thank you, and let me add my congratulations on another well-executed quarter. I have two questions. First, Skyrizzy and Rynvoke are obviously off to great starts, and the raised guidance for them in 2020 is impressive. Previously, AbbVie had provided 2025 guidance of $10 billion.

Payer diversity and payer mix, if you look at it as a percent of the global revenues Medicare part B will be about 2% Medicare part D will be about 16% Medicaid will be about 3% and cash pay will be about 10% So nice balance.

Rick Gonzalez: , , , , ,

Rick Gonzalez: In 2015, of $37 billion, and then in 2017 said that that would be exceeded. I realize that in complicated businesses, there are always pushes and pulls.

Once insecurity along.

The payer base it will be a businesses driven by volume not by price and so that's that's important.

It would be a company that has a strong and growing dividend its underpinned by tremendous cash flow, which provides security.

Rick Gonzalez: But it appears today...

To deliver a growing dividends.

Rick Gonzalez: 2020 Revenue Guidance Implies a

Then over the long term and through the loss of exclusivity in 2023 in the U.S.

Rick Gonzalez: 36.

Rick Gonzalez: Billion Dollar Revenue Number in 2020. So I'm just curious about the reason for the delta.

It also have a number of recently launched products and growth products and back there will be six of them and you think about it you look at Sky Rizzi when vote Venclexta Imbruvica those all have significant growth opportunities ahead.

Rick Gonzalez: for the reason for the Delta. Thank you very much.

Rick Gonzalez: Well, I mean, if you look at Skyrizzy and Rinvoke, obviously, they're off to a very strong start. But when you look at the $10 billion guidance that we had, that still had some level of risk adjustment for the follow-on indications associated with it. And obviously, as we move along, then those risk adjustments will come down, and the probability of success will go up. So by definition, the way we look at things, you would expect Skyrizzy and Rinvoke to be able to exceed that level of performance, assuming all those follow-on indications perform at the level that we would expect, and everything that we know would clearly indicate that that is the case. We're not in a position where we're going to change the guidance.

Them on the Abbvie side, and then you look at the Allergan side, Yes, Velardo. This is a product that has as a it's about $850 million product I think the last numbers I saw showed it was growing about 70% and you have there recently launched oral CDR be that we haven't seen any data on yet as far.

Or is there the revenue performance because that just launched it but I think that will be an important product over the long term. So and then that's underpinned by our late stage pipeline that has 20, new drugs and new major indications and an early stage pipeline that that.

Outlined in his remarks, that's a pretty impressive profile of a company in our industry and that's the kind of company. We were trying to build by combining these two companies together. So I think that that's how we think about it.

Rick Gonzalez: Now, in any complicated business like ours at $37 billion, obviously, there are things like Skyrizzy and Rinvoke that are ultimately performing better. Certainly, when you look at our hematological oncology business, that's performing at a level that we would expect to deliver at least what we had expected back at that point in time, probably a little bit higher. Now, you also have puts and takes, right?

Right, Thanks, very much right.

Thanks, Jeffrey Operator next question please.

Thank you. Our next question is from Steve Scala from Cowen.

Thank you and let me add my congratulations on another well executed quarter I have two questions first scarcity and RIN Voake are obviously off two great starts and the raised guidance for them. In 2020 is impressive previously Abbvie had provided 2000.

Rick Gonzalez: International biosimilars was more aggressive than we had anticipated. But net-net, I think we're comfortable with that level of performance, and more importantly, we're comfortable with being able to deliver the kind of earnings that we would expect. And so I think we feel very good about how the company is performing and our ability to deliver on those long-term expectations. The other thing I'd say is, as you look at biosimilars, obviously, biosimilars are an important aspect of our particular business. And, you know, we're now at a point where we're basically lapping the first year of biosimilar experience in the international markets. And it gives us the ability to be able to look back and say, did our strategy work that we had put in place?

In 2005 guidance of 10 billion for these two products and I'm just wondering how youre thinking about that number now and then secondly, the company had given 2020 revenue guidance in 2015 of 37 billion and then in 2017 said that that would be exceeded I realize that.

In complicated businesses, there are always pushes and pulls but it appears today's 2020 revenue guidance implies a 36 billion dollar revenue number in 2020.

So I'm just curious for the reason for the Delta. Thank you very much.

Well I mean, if you look at.

Rick Gonzalez: And I think we've obviously been able to learn from what that strategy has been able to do. In general, I would tell you that I'm feeling pretty good about how the strategy played out. On the aggressive side, obviously, the biosimilar competitors, before they entered the market, priced their products more aggressively than we had seen with the analogs. And so the shape of the curve was different, which we've talked about a number of different times. Having said that, our strategy was to make sure that we could maintain as much share as possible of Humira and keep it as profitable as possible. And we can now step back and look at what that looks like.

Sky, Rosie and Rune Voake, obviously, they're off to a very strong start.

When you look at the $10 billion guidance that we had that still had some level of risk adjustment for the follow on indications associated with it.

And obviously as we move along then those risk adjustments.

Will will come down probability of success will go up so by definition by the way. We look at things you would expect Sky resident were in both to be able to exceed that level of performance assuming all of those follow on indications.

Perform at the level that we would expect.

Rick Gonzalez: Well, what it basically looks like is we have maintained about two-thirds of the volume. If you look specifically at the countries that went biosimilar and you look at what the erosion level is in those countries, it's about 44, 45% within those countries. So what that means is we've obviously maintained a tail of about 55% of the Humira volume, which is a pretty significant tail when you think about a product of the size of Humira. So I think overall, we feel good about how our strategy played out, despite the fact that biosimilar players were more aggressive. I think as we look at the U.S., there are some things that we can translate from that experience, and it gives us some feel for how the U.S. will evolve as we enter that biosimilar phase in 2023.

And everything that we know would clearly indicated that that is that is the case, we're not in a position where we're going to up the guidance now and any complicated business like ours on the on the.

On the $37 billion, obviously, there are things like sky resume remote that are ultimately performing better.

Sure.

Certainly when you look at our Hematological oncology business, that's performing at a level that we would expect.

To deliver at least what we had expected back in that point in time, probably a little bit higher yeah. You also puts and takes right international bio Similars a were more aggressively than we had anticipated but.

No I think you know, we're comfortable with that level of performance and more importantly, we're comfortable with being able to deliver the kind of Ah earnings that we would expect.

And so I think we feel very good about how the company's performing and our ability to deliver on those long term expectations. The other thing I'd say is as you.

Look at the bio some obviously biosimilar very important aspect of our of our particular business.

And you know we're now at a point, where we're basically lapping the first year of bio similar experience a in the international markets and it gives us the ability to be able to look back and.

Rick Gonzalez: Obviously, we have products like Renvoke and Skyrizzy that are growing rapidly. We have a number of years to be able to drive that, and we're making very good progress on the follow-on indications, and therefore, we should have a broad set of indications, approved indications for those assets, which should drive very significant growth leading into that LOE event. The strategy that we'll put in place is the exact same strategy that we used in the international markets. Our goal is to maintain as much market share as we can in as profitable a way as we can. There is no market exactly like the U.S. market outside the U.S., but what I would say is we would expect it to be competitive, like the international markets.

They did our strategy work that we had put in place.

And I think we've obviously been able to learn from what that strategy.

He has been able to do in general I would tell you that I'm feeling pretty good about how the strategy played out.

On the.

On the aggressive side, obviously the biosimilar.

Our competitors before the entered the market price more aggressively than we had seen with the analogs and so the shape of the curve was different which we've talked about a number of different times, having said that our strategy was to make sure that we could maintain as much share as possible acumera and maintain.

Rick Gonzalez: We'll have more competitors entering the U.S. market, so I think the shape of the curve will be similar to what we saw in the international markets. But I'd say as far as our ability to maintain share, we certainly in the U.S. have at least the same competitive position that we have in the international markets, and, in all likelihood, we have a stronger competitive position in the U.S. market, so I would say we would expect to fare at least as well or better from the standpoint of maintaining that tail over time. And so we're feeling better about where we stand, both the progress that we're making on the assets that will allow us to be able to drive growth over the long term and the experience that we're getting with dealing with biosimilar competition in these markets.

As profitable as possible and we can now step back and look at what does that looked like well basically looks at it looks like as we have maintained about two thirds of the volume.

If you look specifically at the countries the went biosimilar and.

And you look at what the erosion level is in those countries. It's about 40, 445%.

Within those countries so.

So what that means is we've obviously maintained a tail.

Of about 55% of the Humira volume, which is a which is a pretty.

Our revenue, which is a pretty significant tail. When you think about a product of the size.

Of Acumera. So I think overall, we feel good about how our strategy played out.

Rick Gonzalez: Thank you, Steve. Operator, next question, please.

Rick Gonzalez: Thank you. Our next question is from Naven Jacob from UBS. Hello, thanks for taking my question.

Despite the fact that.

The Biosimilar players were more aggressive I think as we look at the U.S. There are some things that we.

Rick Gonzalez: A couple on RINVOC and SCIRESI. Number one on SCIRESI, wondering what the feedback from physicians and patients is regarding, I realize it's very early, but regarding average duration of therapy. How should we be thinking about that relative to your experience with Humira?

In a weekend translate out of that experience and and it gives us some feel for how the us will will evolve as we enter that biosimilar phase in 2023.

Obviously, we have products like when vogan, Scott Rizzi that are growing rapidly we have a number of years.

Rick Gonzalez: And then on RINVOC, wondering about the Q4 sales number, which came a little bit lighter relative to how we were thinking about it based on the scripts. Wondering what the dynamic is from a dollar per prescription standpoint, and how couponing and sampling are affecting that. There was some commentary from Pfizer on Zelgen's pricing that raised some questions about pricing in this space, obviously very early on, but I would love any color there. And as a corollary to that, with regard to the differences in the channel mix for RINVOC versus SCIRESI, any kind of color there would be appreciated, particularly as you said that you have very good access in the commercial setting for RINVOC, wondering about Thank you so much.

To be able to drive that we're making very good progress on the follow on indications and therefore, we should have a broad set of indications approved indications for those assets, which should drive very significant growth leading into that Oh, we have that the strategy that will put in place is the exact same strategy.

We did in the international markets. Our goal is to maintain as much shares we can and as profitable away as we can.

There is no market exactly like the U.S. market outside the U.S., but what I would say is high.

Expected to be competitive like the international markets will happen, we'll have more.

Competitors entering the U.S. market. So I think the shape of the per will be similar to what we saw in the international markets.

But I'd say as far as our ability to maintain share a we're certainly in the U.S. have at least.

Rick Gonzalez: Okay, so... On the first question, this is Rick. Average duration of therapy. Obviously, Skyrizzy is a quarterly dose product. It has a loading dose that occurs in the first phase.

The same competitive.

And that we have an irrational markets and in all likelihood we have a stronger competitive position in the U.S. marcon. So I would say, we would expect a fair at least as well or better.

Rick Gonzalez: So we don't have a tremendous amount of experience yet, but I'd say the experience that we have thus far is consistent with what our original launch assumptions would be, and that is that the duration of therapy would be very long at Chimera levels or above. But obviously, it's more convenient to have quarterly dosing. And so we're not seeing anything there that is different than what we would have anticipated, albeit it's early on, right? As far as Renvoke is concerned in the fourth quarter, I'd say Renvoke is tracking well.

From a standpoint of maintaining that tail.

Overtime, and so we're feeling better about where we stand both.

The progress that we're making against the assets that will allow us to be able to drive growth over the long term and new experience, we're getting with dealing with biosimilar competition a in these markets.

Thanks Keith.

Operator next question please.

Thank you. Our next question is from Dave.

Jacob from you'd be yes.

Rick Gonzalez: You know, it's continuing to gain market share. But it didn't get its significant uptick in market access until January. There was a fairly significant jump from December to January, so there was still a fair amount of prescriptions that were being driven through our access program, where we provide patients with free products if they don't have access. But now, as I mentioned, we're over 95%. And our policy is, once we've achieved access to an account, we no longer allow bridge access for those products. In other words, from a compliance standpoint. And so you should start to see those paid prescriptions ramping up in line with what we would expect the access to be. Skyrizzy has very similar kinds of access. As far as the channel mix is concerned, I'm going to have Rob cover that.

Hello, Thanks for taking my question a couple on RIN Vulcan's Clerisy number one on scar easy a wondering what the feedback from physicians and patients are regarding I realize it's very early but regarding average duration of therapy.

How should we be thinking about that relative to your experience with humira.

And then on a written folk a wondering about the Q4 sales some of which came a little bit lighter relative to how we're thinking about it based on the scripts wondering what the dynamic is from a.

A dollar per.

Prescription standpoint, how the couponing and sampling or is affecting that there was some commentary from Pfizer on xeljanz pricing.

That's a that's brought up some questions about pricing in this space, obviously very early on but would love any color there and as a corollary to that.

With.

Regardless to the differences in the channel mix for written Voc versus Clerisy any kind of color there would be appreciated.

Rob: Hi Naveen, it's Rob. So if you think about the difference in the patient profile with RA versus psoriasis, you obviously have an older patient population, so you'd expect RINVOC to be higher in terms of Medicare Part D. To give you just a range, it's around 20% of the RINVOC channel mix is Part D, whereas with SCIRIS-E, it's closer to 10%.

Particularly as you said that you know you've you have very good access and the commercial setting for rent Voc wondering about the access and the other parts of the channel as well. Thank you so much.

Okay.

So.

So.

On the first question. This is Rick average duration of therapy, obviously sky rosy as a quarterly dose product as a loading dose that occurs in the first phase.

Rob: The only other thing I'd mention is the one thing that is very encouraging to us is that if you take Skyrizzy, about half, 49% of the patients are naive patients, and the other 51% are obviously second line and beyond. If we look at Renvoke, about 40%, 38%, 39% are naive patients, which at this phase of the launch is higher than what we had originally modeled, and the remaining patients are second line and beyond. The other thing I'd say is that we obviously track how we're doing against various competitors. Renvoke now has an in-place share that's the equivalent of about 70% of Zeljans and is obviously growing at a pretty rapid pace, and so I think that's an encouraging sign as well.

So we don't have a tremendous amount of experience yet.

But I'd say the experience that we have the thus far.

And with what our original launch assumptions would be and that is that the duration of therapy would be very high and chimera levels or above obviously, it's a more convenient.

To have quarterly dosing and so we're not seeing anything there that that is different than what we would have anticipated, albeit it's early on.

Right.

As far as when vote in the fourth quarter I'd say remote is tracking well you know, it's continuing to gain in place share.

Now I Didnt get.

It's a significant uptick in the market access until January.

There was a fairly significant jump from December to January. So there was still a fair amount of prescriptions that were being driven through the.

Rick Gonzalez: Thank you, Naveen. Operator, next question, please. Thank you. Our next question is from Terence Flynn from Goldman Sachs. Hi. Thanks for taking the questions. Congratulations on the quarter for me as well.

Our access program.

Where we provide patients if they don't have actually as we provide them with the.

Rick Gonzalez: One more on the guidance front. When you do give the pro forma guidance post-deal close, I was just wondering if we should expect new longer-term guidance on that front as well. And then, again, I appreciate all the detail on the pipeline. In the slides, you list six proof-of-concept readouts this year. Just wondering, of those assets, which do you view as most transformational? Thank you.

Fleet product.

Through our bridge program, but now as I as I mentioned were over 95%. Our policy is once we've achieved to access into an account we no longer allow a bridge access for those products in other words from a compliance standpoint, and so you should start to see.

Mike: Okay. On the pro forma guidance, we haven't made a final decision. Obviously, we'll be providing for calendar year 20. But we haven't made a decision whether we'll go out any further than that. So I'd say that's a decision that we'll make as we get closer to the close and ultimately announce what the combined guidance is. Mike, do you want to cover number two?

Those paid prescriptions ramping inline with what we would expect the access to be Sky Rizzi has very similar kinds of access.

As far as the channel mix is concerned I mean have Rob cover that.

Venus, Rob So if you think about the difference in the patient profile with our.

For psoriasis, obviously, the older patient populations you'd expect renvela to be higher in terms of Medicare part D to give it just a range it's around 20% of the Renvela channel mix is part D, whereas with Sky Rizzi, it's closer to 10.

Mike: Sure. So, as you mentioned, we have six proof-of-concept readouts this year in our early-to-mid-stage pipeline, and if I wanted to, you know, pick some examples that would be most transformational, I think I would point to ABBV3373, our TNF steroid conjugate. If you look at the basic biology, the ability to deliver this very, very high-potency steroid directly to the activated immune cells that are doing the damage in these diseases really has tremendous potential. In our preclinical work and in our model systems, we see results that are really unlike anything we've ever seen with other sorts of agents, and we can deliver that kind of impact in those systems without systemic steroid effects. So, if that plays out in the clinic in the same way it has in those model systems, that would really be transformational across a wide range of diseases, across a range of TNF-mediated diseases like RA, other rheumatologic conditions, you know, inflammatory bowel diseases, and many others. And you could also use that same technology with different targeting warheads to get into areas where there really aren't effective therapies today, So, that really has transformational potential. You know, maybe I would point to one other program on the ONC side.

The only other thing I'd mentioned is the one thing that is very encouraging to us is.

If you take Sky rosy.

About half 49% of the patients are naive patients and the in the other 51% or obviously second line and beyond.

If we look at written vote, it's a it's about 40% 30, 839% our naive patients.

Ones, which at this stage, we will launch is higher than what we had originally modeled and the remaining or second line and beyond.

Thing I'd say is we obviously track how we're doing against various competitors. It's now a remote now has an in place share that's the equivalent of about 70% of.

Xeljanz and obviously growing at a pretty rapid pace and so I think thats, an encouraging sign as well.

Thank you mean, operator next question please.

Thank you. Our next question is from Terence Flynn from Goldman Sachs.

Hi, Thanks for taking the questions congrats on the quarter for me as well.

One more on the guidance front when you do give the pro forma guidance post deal close was just wondering if we should expect new longer term guidance on that front as well and then again appreciate all the detail on the pipeline on the slides you with six proof of concept for Readouts. This year, just wondering of those assets.

Mike: If you look at our work in apoptosis, there really is a tremendous opportunity, I believe, in the future, to get into solid tumors with our apoptosis programs. And one program that I'll have a readout for, at least from the monotherapy component this year, is probably B.1.5.5, our B7H3-targeted Excel delivery. Thank you, Terence. Operator, next question, please. Thank you. The next question is from Vamil Divan from Muzuho. Hi, great. Thanks for taking my questions. I just want to actually follow up on the comments Rick made regarding Humira's US erosion interface when biosimilars arrive. And I think you said the overall shape of the curve you think will be similar to what we've seen outside the US.

Which do you view as most transformational thank you.

Okay on the pro forma guidance, we haven't made a final decision, obviously, we'll be providing for calendar year 20.

We have made a decision whether we'll go out any further than that.

So I.

I'd say, that's a day.

Vision that will make as we get closer to.

To the clothes and ultimately.

Announcing what the combined guidance is Mike do you want to cover remember too sure. So as you mentioned, we have six proof of concept read out this year.

Rick Gonzalez: And I think you also previously mentioned that part of the reason for the Allegan deal was to kind of give you the ability to address the various scenarios of human error erosion. So I'm just trying to get a sense that you think about the scenarios and how this might evolve in 2023 or 2024. Do you expect that you'll be continuing to grow sales and earnings right through those years? Or do you think that if it is a somewhat rapid erosion, there might still be a little bit of a decline during that time period? And then my second question is just around pricing, and it sounds like you got maybe one or two percentage points of pricing growth for AMERA this year. Just wondering if that's sort of a reasonable expectation for 2020 for AMERA, and also maybe just for the next couple of years, do you think you'll still be able to get sort of a low single-digit amount of price growth? Thanks.

In our early to mid stage pipeline and if I wanted.

To pick some examples of we most transformational I think I would point to ADB 3373, our TNF steroid conch again, if you look at the basic biology, the ability to drive to deliver this very very high phone to start directly to the activated immune cells that are doing the damage in these diseases.

Really has tremendous potential.

In our preclinical work in our model systems, we see results that are really unlike anything we've ever seen with other sorts of agents and we can deliver that kind of impacting those systems without systemic star effects. So that plays out in.

Rick Gonzalez: Okay, Vamil, this is Rick. So I'll take the first question, and then Rob will cover the second question for you. You know, we're obviously not in a position where we're going to give 2023 guidance at this point. But what I was referring to is, if you look at the consensus today, what it shows for Humira is that it basically is a stair step down over the course of three or four years. I would say our experience in international markets, by the way, multiple biosimilar competitors coming into the market simultaneously created a sharper decline, a deeper decline in year one, and then it's pretty much stabilized at that level. There might be some slight erosion after that, but relatively minor or moderate after that.

In the clinic in the same way it has in those model systems that would really be transformational across a wide range diseases.

Just a range of mediated diseases.

Like our ray or other rheumatologic conditions.

Yes, inflammatory bowel diseases, and many others have any could.

So use that same technology with different targeting warheads to get into areas, where there really aren't effective therapies today like lupus for example, so that really has a transformation potential.

I would point to one other program on the young side. If you look at our work in a pop ptosis, there really is a tremendous opportunity.

I believe in the future to get into solid tumors with our a pop doses programs and one program that will have a readout or at least from the monotherapy component this year.

155, AR Vseven age three targeted XL delivery.

Rick Gonzalez: When I describe the shape of the curve, I think that's a more reasonable shape of the curve that we would expect in the U.S. market, based on the fact that there will probably be seven competitors that enter the marketplace in 2023. So as far as growth is concerned, it is our obvious objective to make sure that we're in a position that we can grow over the long term. That's an important objective for us. It's certainly an objective that we have been able to deliver on throughout our history as a company, and it's an important goal for us. Now, that doesn't mean that in 2023 there couldn't be some step down in 2023 and then a quick return to growth thereafter. But ultimately, as we get closer, I think we can provide more accurate guidance.

Thank you Karen.

Operator next question please.

Thank you. Our next question is from Vamil Divan from losing Hall.

Hi, great. Thanks for taking my questions I just wanted to follow up on the comments Rick made.

Regarding humira U.S. erosion and face when Biosimilars arrive and I think you said the overall shape of the curve you think will be similar low.

We've seen outside the us.

He also previously mentioned that part of the reason for the Allegan deal as to kind of give you the ability to address the various scenarios of generic erosion. So I'm just trying to get a sense that you think about the scenarios and how this might evolve in 2023 2024 do you expect to you'll be continuing to grow sales and earnings right.

Through those years or do you think debt if it is still a rapid erosion. So there might still be a little bit of a decline during that time period and then my second question is just around pricing.

Rick Gonzalez: But I have a high level of confidence that we are building an engine that will allow us to be able to grow through it over a long period of time. Allergan plays an important part in making sure that we can maintain the investment profile that we want to maintain in R&D and SG&A to make sure that we have the levels of cash flow to continue to support the dividend and grow the dividend. It plays a very important role in a number of aspects of how we manage the business over the long term. Bye.

Sounds like you've got maybe one or two percentage points of pricing growth Premier. This year. Just wondering on is that sort of recently expectation for 2024.

Right and also maybe just for the next couple of years do you still get sort of low single digit amount of price. Thanks.

Okay bundled this is Rick so I'll take the first question and then Rob will cover the second question for you.

We're obviously not in a position where we're going to give a 2023 guidance at this point.

Right.

What I was referring to is a if you look at consensus today, what it shows for Humira is basically is a stair step down over the course of three or four years I would say our experience in international markets by the way multiple biosimilar competitors.

Rob: I'm sorry, Rob. So, I'll take your question on U.S. Humerus. So, of the approximate 9% growth we've guided, volume is going to be mid-single digits, and price will be low-single digits. I think for modeling purposes, it's fair to model low-single digits going forward. We'll obviously provide that guidance at the appropriate time, but that's the best way to think about it. Thank you, Vamil. Operator, next question, please. Thank you. Our next question is from Randall Stanicky from RBC Capital Markets. Okay. Thanks, Rick. There's been a problem.

Coming into the market simultaneously.

Created a sharper.

Decline a deeper decline in year, one and then it's pretty much stabilized.

At that level might be some slight erosion after that but but relatively minor or moderate.

Rick Gonzalez: Trend, Enlarge Biopharma towards their dusting legacy products.

Rick Gonzalez: Products, you're getting more from Allergan. How are you thinking about potential divestitures from the combined Unknown Speaker And then, just secondly, on Oralisa, you talked about the need to build awareness back.

After that that when I described the shape of the curve I think thats, a more reasonable shape of occur, but we would expect in the U.S. market based on fact, there'll be probably seven competitors that enter the marketplace in 23, so as far as growth it is our.

Rick Gonzalez: Is that still a $2 billion opportunity, and how are you thinking about the potential to bring that back outside?

Rick Gonzalez: You know, I mean, every company in our industry, for the most part, has some level of legacy products. We do, as well as others. I think many people want to divest those products, typically not because those products aren't profitable and provide significant earnings, but because they depress their overall growth if they're too large, as it relates to their overall, their overall base of business.

This objective to make sure that we're in a position.

That we can grow over the long term.

That's an important objective for us and certainly the objective that we have been able to deliver on.

Throughout our history as a company and it's an important objective for us now that doesn't mean.

In 2023, there couldn't be some step down in 2023, and then return quotes we had a growth thereafter.

Rick Gonzalez: I would say, as we look at our profile and our ability to be able to grow, we don't believe that that's a significant issue for us. That doesn't mean that at some point in the future, we might not reevaluate if we thought that was in the best interest of the company overall, but I'd say that's not something that we have any plans for at this point in time. Oralisa, the point you raised is an accurate point. The challenge that we've had with Oralisa and endometriosis has been activating those patients at the rate that we would have expected. We have made some changes in the fourth quarter to our go-to-market strategy, but we'll have to see how those play out.

But ultimately as we get closer I think we can provide more accurate guidance.

But I have a high level of confidence that we are building an engine that will allow us.

To be able to grow through it over a long period of time over the longer period of time allograft plays an important part of making sure that we can maintain the investment profile that we want to maintain and R&D and asked you need to make sure we have.

The levels or cash flow to continue to support the dividend.

And grow the dividend.

Plays and very important role a number of aspects.

How we manage the business over the long term.

Mike.

Rick Gonzalez: And also, we'll have the launch of the uterine fibroid indication in 2020. That's a different patient population, and so I think it will have a different activation profile. But I think we have to see how endometriosis, whether or not we get an inflection point here that's different than what we've seen thus far before we make any predictions about how we would change the long-term projections. We fundamentally believe this is a good drug. Everything we know about it says it's a good drug and it ultimately fits an important need. But we're obviously going to have to change that activation curve to get to the level of expectation that we have for the drug.

I'm sorry, Rob so follow its Ross I'll take your question you assume area. So of the approximate 9% growth was guided volumes going to be a mid single digits and price will be low single.

Yes, I think for modeling purposes, it's fair to model low single digits going forward, obviously provide that guidance the appropriate time, but thats the best way to think about it.

Thank you Tom owner Operator next question please.

Thank you. Our next question is from Randall Stanicky from RBC capital markets.

Great. Thanks Records.

Trend.

The large biopharma towards that upstream legacy products.

Abbvie has legacy products, you're getting more from Allergan, how are you thinking about potential divestitures.

Mind.

Entity and then just secondly on or will you.

You talked with the need to build awareness activation is that still a 2 billion or opportunity and how are you thinking about.

Rick Gonzalez: Thanks, Randall. Operator, next question, please.

Actual towards like that backup thanks.

Yeah.

Rick Gonzalez: Thank you. Our next question is from Tim Anderson from Wolf Research. Thank you. A couple of questions, please. Just to round out the discussion on prior 2025 guidance for certain products, (inaudible) I've got three of them so far, and Kleksa, and I'm.

No I mean every week every company our industry for the most part has some level of legacy products. You know, we do as well as others I think many people wanted to divest those products are typically not because those products are profitable and provide.

Significant earnings.

But because they depressed their overall growth if there are two large as it relates to their overall, though overall base of business I would say as we look at our profile and our ability to to be able to grow we don't believe that thats a significant.

Rick Gonzalez: [inaudible]

Rick Gonzalez: You set, you know, really high 2025 guidance, I think of $11.5 billion, and then in CLEXT, I think you guided for $6 billion, and I think it finished out the year here at $800 million. So, any comments on those two products? And then a second question just on, in the context...

Second issue for us that doesn't mean that at some point in the future we might not reevaluated. If we thought that was in the best interest to the company overall, but I'd say, that's not something that we have any plans for Ed at this point in time.

Rick Gonzalez: in the context of FTC being more unpredictable. With Brazicumab, the message or a person could argue for different reasons. FTC might raise.

Oil as the points you raised as an accurate point the challenge that we've had.

With oral as a in endometriosis has been activation of those patients at the rate that we would have expected.

Rick Gonzalez: I'd raise an eyebrow about Astra taking back an asset that they got rid of.

Rick Gonzalez: Originally, I think back then it wasn't core to their business, and frankly, when you look at Astra and what they concentrate on now, it's hard to see where it fits.

We have made some changes in the fourth quarter.

To our go to market strategy will have to see how those play out.

Rick Gonzalez: So FTC could...

And and also will have the launch of.

Rick Gonzalez: I could potentially question whether Ass was really a committed, competitive developer of that asset. I'm just wondering if you can share your thoughts on that. Thank you.

Uterine fibroid indication in 2020, that's a different patient population and so I think it will have a different.

It will have a different activation profile and.

Rick Gonzalez: As far as BenClexta and Imbruvica are concerned in the long-term guidance, we feel very comfortable with our long-term guidance for those two assets. You know, if you look at this year for BenClexta, it'll be an important inflection year for BenClexta, and we would expect it to continue to grow quite nicely over time. Obviously, multiple myeloma T11-14 is a significant opportunity for BenClexta. I think that represents roughly 20% of all myeloma patients, and multiple myeloma is obviously a very big market, so, you know, we feel good about that. As far as the FTC is concerned, the way this process normally works is you bring in the players that you're considering to acquire a product, which we and Allergan did. And so the FTC has had an opportunity to interact with both of the players and give us feedback on those players, so I think you can conclude from that that we wouldn't move forward with a player that the FTC told us they were uncomfortable with.

I think we have to see how endometriosis.

Or whether or not we get an inflection point here that's.

Different than what we've seen thus far before we make any predictions about how we would change the long term projections. We fundamentally believe this is a good drug everything we know about it says it's a good drug and it ultimately fits and important need.

But we're obviously going to have to change that activation per ton.

Get to the level of expectation that we have had for that for the drug.

Thanks Randall operator next question. Please. Thank you. Our next question is from Tim Anderson from Wolfe Research.

Thank you couple of questions.

Just to round out the.

On prior 2025 guidance for certain products.

You asked about.

Three of them so far.

Okay and Imbruvica you can just talking about how those are trending today relative to those projections right because it seems like it's doing great.

Rick Gonzalez: Thank you, Jim. Operator, next question please. Thank you. Our next question is from Andrew Baum from Citi. Thank you. Just in the Sarasota segment, you run a very impressive trial versus the leading companies.

So really high 2025 guidance I think of 11 million then collect a I think you guided for 6 billion.

I think it finished out the your here 800 million.

So in your comments on those two products and then second question just on in the context of.

Rick Gonzalez: [inaudible]

Rick Gonzalez: Accelerate Eating In

Do you see more unpredictable.

Rick Gonzalez: , , , , , , , ,

Rick Gonzalez: So, Mike, why don't you cover one, three, and I'll come back and cover the count.

With the Brazilian.

Such or a person could argue for different reasons FTC might reason eyebrow.

Mike: Sure, this is Mike. With respect to the head-to-head data we just released, you know, in the last, you know, several weeks against the pathentics, really was a very strong result. And what I would say is it highlights a number of the things that you said. One, we drive very, very high levels of response. That response is very durable over time.

Astra taking back an asset that they got rid of originally thing back then it wasn't or their business and frankly, when you look at Astra and what they constantly.

Great and now it's hard to see where is the FCC could potentially question, whether Astra is really a committed competitive developer that asset.

You can sure.

Thank you.

Sure.

Mike: Although all the data haven't been presented, they will be presented at an upcoming medical meeting. You know, we said that we had across all of the ranked secondary endpoints, so it was a very sort of broad-based result. And we had very good data at 16 weeks, as you said, so we think that that's going to continue to drive the momentum of Sky RISD into this space. Now, having said that, Sky RISD is already performing extremely well, and we would expect that to continue. So with the – for your third question on the competitive space for BTK inhibitors, you know, we feel very, very good about the package of data that we have delivered around Imbruvica. It's very broad.

As far as Venclexta imbruvica.

Our concern in the long term guidance, we feel very comfortable with our long term guidance for those two assets.

Now if you look at this year for Venclexta, it'll be an important inflection year for Venclexta and we would expect it to continue to grow quite nicely over time.

Obviously, the multiple myeloma into 11.

14 is a significant opportunity for Venclexta I think that represents roughly 20% of a myeloma patients.

And my long, there's obviously, a very big market.

So we feel good about that as far as the FTC is concerned the way this process normally works.

As you bring in the players that you are considering to acquire a product, which we and Allergan did and so the FTC has had an opportunity to interact with both of the players.

And give us feedback around those players. So I think you can conclude from that.

We will move.

For the player that the FTC told us they were uncomfortable with.

Thank you Jim Operator next question. Please. Thank you. Our next question is from Andrew Baum from Citi.

Thank you.

Mike: We have five large-scale randomized readouts, and we show a robust survival benefit. And that's a data advantage that's very hard to overcome. If you look at the launch of some of the follow-on covalent BTK inhibitors, you know, our data package still is the broadest and we believe is the strongest in terms of showing the overall benefits. And, you know, the points of differentiation that folks had talked about in the past haven't really materialized, so we feel good about our competitive position there.

Just in the Serasa segment.

You run the very impressive travels.

Yes, the leading IL 17, seemingly taking away all that Keith starting points, both consensus that says whether the speed of I'm sad to respond to.

As to what extent, you think youre going to accelerate eating into the aisle 17 segment by leveraging that trial in the Serasa setting and then secondly back.

CLL could you just talked to how you see the near term competitive risk.

From the introduction of cow quince, among patients with struggling with Imbruvica tolerance I realize it's only menasha that's patients as they tolerate the fast yes therapy, but whether we're going to see any patient shift across as it comes to.

Mike: You know, they'll take some share, as you've seen in MCL, but it's nothing that would change our ability to grow Imbruvica. With respect to the non-covalent inhibitors, I think the place for those is less clear. As I've said, you know, we have many large-scale phase three data readouts, including survival benefits. So until those molecules really have an equivalent data set, it's going to be very, very difficult for them to compete in the space where Imbruvica plays. Now, there are, you know, a small number of patients who have cysteine mutations that lose response to covalent BTK inhibitors because of that. One might expect a non-covalent inhibitor to work there, but that's really, you know, a much smaller opportunity, and that follows the use of the covalent inhibitors. And we would say in that space that Clexa-based regimens are probably the best option and certainly have the most data, you know, today.

Okay, and then second let Tom I'm now that you have the conveyed that.

In the no because its inhibitors coming onto the seem with Okcular Lilly and others. Thank you.

So Mike once you cover one three and I'll come back some cover the cow Quinn's question.

This is Mike with respect to their head to head data, we just released.

Last.

Several weeks ago, Cosentyx really was a very strong results and what I would say is it it highlights a number of the things that said one we drive very very high levels of response that response is very durable over.

Time.

Although all the data haven't didnt presented they will be at at an upcoming medical meeting.

Rick Gonzalez: And then to your second question, as it relates to whether or not we'll see patients being moved off of Imbruvica and on to CalQuints based on side effect profiles, we don't believe that will be the case.

We said that we had across all of the rank secondary endpoints is very sort of broad based result, and we had very good data at 16 weeks as you said, we think that that's going to continue.

Two I tried to them.

Rick Gonzalez: I mean, as Mike pointed out, when you look at the body of data around Imbruvica and particularly the survival benefit that we see with Imbruvica, physicians are reluctant to move a patient off of a drug that gives them the opportunity to be able to have that level of survival benefit to something that, you know, has less data to be able to support that. The guidelines reflect that as well. And you know, most physicians know that when they have a side effect profile that they're having difficulty managing through that, you know, routinely prior to CalQuints being on the market, what they would typically do is take the patient off of therapy for a short period of time until it resolves, and then put them back on therapy. And many patients would ultimately be fine when they were put back on therapy.

Bantam ups got raising into this space now having said that scares. He is already performing extremely well and we would expect that continue.

So with the for your third question on the competitive space for BTK inhibitors.

We feel very very good about that package of.

Data that we have delivered around Imbruvica is very broad we have five.

Large scale randomized readouts, we have a robust survival benefit and that's a data advantage that's very hard to overcome.

If you look at at at the launch of some of the follow on covalent BTK inhibitors.

Our data package.

Is the broadest and we believe is the strongest in terms are showing the overall benefits.

And you know the points of differentiation that folks had talked about past haven't really materialized. So we feel good about our competitive position there they'll take some shares you've seen in mcl, but it's nothing that that.

Rick Gonzalez: So moving to another non-differentiated product, we don't think it will have a fundamental impact. We're obviously watching the shared data. It's early on because the latest shared data that we have is still November, and as you know, they were approved in November. Now they were on guidelines for most of 2019 in CLL, but their share is very low. You know, they have about 1% share in first line, 2% share in second line, and about 6% share in third line. But most of those patients in third line, about half of them are BTK failures and Bruvica failures. So thus far, we don't see anything that would suggest that it's having a significant negative impact on our performance. Thank you.

Would that change our ability to grow imbruvica with respect to the non covalent inhibitors I think that though the place for those is less clear as I've said, we have many large scale phase three data readouts, including survival benefits. So until those molecules really have an equivalent dataset it's going.

To be very very difficult for them to compete in this space, where imbruvica place now there are.

Small number of patients 60 mutations that that whose response to covalent BTK inhibitors because of that one might expect to non covalent inhibitor to work there, but thats really a much smaller.

Entity and that follows the use of the Codell inhibitors, and we would say in that space that the text based regimens are probably the best option. It certainly has the most data.

Operator: Thank you, Andrew. Operator, we have time for one final question. Thank you. Our final question today is from David Risinger of Morgan Stanley. Thanks very much. And I wanted to add my congratulations as well. I have two questions for you, Rick, and the team. So with respect to looking at analogs, branded XUS Remicade has stair stepped down 30% annually over the past five years since biosimilars first launched. And the 2019 sales were less than 20% of the

Today.

And then to your second question as it relates to whether or not we'll see.

Patients being moved off of.

Of Imbruvica and on to calculations based on side effect profiles. We don't believe that will be the case I mean, I think as Mike pointed out when you look at the body of data around Imbruvica and particularly the survival benefit.

That we see with Imbruvica physicians are reluctant to move a patient.

David Risinger: 2014 Sales. Could you discuss the considerations for AbbVie with your team?

With a drug that gives them the opportunity to be able to have that level of survival benefit to something that you know as a has less data to be able to support that the guidelines reflect that as well and you know most physicians know that when they have a side effect profile.

David Risinger: has evaluated it as a potential analog for Humira.

David Risinger: Sera, Declined Prospects, and then, second, with respect to Oralisa, could you discuss efforts to

David Risinger: Women who may be

That they're having.

Difficulty managing flu that you know they routinely prior who calkins being on the Mark what they would typically do is take the patient off of therapy for for a short period of time until it resolved and then put them back on therapy in many patients would ultimately be five.

David Risinger: to take hormonal therapy. Thank you.

Rick Gonzalez: Yeah, so David, this is Rick, for your first question. Yeah, I think the difference between Remicade and Embril is actually, and the experience that we had with Humira was, in most of those cases, you know, only one or two competitors came in at a time. And so what you're seeing is essentially the way we had originally modeled Humira was that, you know, at year three, we would get to the levels that we're at now because it would stair step down. But I think what we learned in that process is that when four competitors entered the market at one time, the competitive dynamics between them to try to get share created an environment where they became far more aggressive early on. So I don't think the curve will look, you know, as it won't look as if it is the same as Remicade. But that doesn't mean that over time, we won't see some moderate continued erosion.

When they were put back on therapy, so moving.

To another non differentiated product.

We don't think we'll have a fundamental impact we're obviously watching the share data. It's early on because the latest share data that we have is still November and as you know they were approved in November and now they run guidelines for most of 2019 in CLL, but this.

Share is very low at about 1% share in first line, 2% share in second line about 6% share in third line, but most of those patients and third line about half of them.

Our.

BTK failures and move it got failures.

So thus far we don't see anything.

That would suggest that it's having a significant negative impact on our performance.

Rick Gonzalez: But it's, you know, for a business of our size and with the growth prospects of our business, that's not something that would inhibit our ability to be able to grow. I think you can see we grew through; we ultimately had positive revenue growth in 2019. Despite the fact that we had, you know, a very significant portion of our international business go biosimilar in 2019, the second question is part of the activity that we're working on now to try to drive activation at a faster rate in women on oralisa. That is one component. I wouldn't say it's the most significant component, but it is one component to better educate women on what this therapy is all about, what the side effect profile of this therapy really looks like, the safety profile of it, and make sure that we do that in a way that it's easily accessible for women in that age group, meaning it has a social media aspect to it that allows them to be able to access accurate information about Or And so that is part of the changes that we made in the fourth quarter. We're just going to have to see how those changes, the impact those changes have over time.

Thank you Andrew operator, we have time for one final question.

Thank you. Our final question today is from David Risinger from Morgan Stanley.

Thanks, very much and I wanted to add my congrats as well I have two questions.

For you Rick and the team so with respect to looking at analogs branded ex US Remicade has stair step down 30% annually over the past five years since bio similars for.

Launched and the 2019 sales were less than 20% of the 2014 sales. So could you discuss the considerations for Abbvie. When your team has evaluated it as a potential analog sports you Mira decline prospects and then.

Second with respect to oral less I could you discuss efforts to change the mindset of younger women, who may be hesitant to take hormonal therapies. Thank you.

Yeah, a Sunday this is Rick for your first question I think it a difference between Remicade and Enbrel as well actually.

And the experience that we had with Humira was in most of those cases, you only one or two competitors came in at a time and so what you're seeing is essentially the way. We had originally modeled humira was that a you know it year three we'd get to the levels that we're at now because it wouldn't stair step.

David Risinger: Thank you, David. That concludes today's conference call. If you'd like to listen to a replay of the call, please visit our website at investors.abbvie.com. Thanks again for joining us. Thank you. And this does conclude today's conference. You may disconnect at this time.

But I think what we learned in that process is when for competitors enter the market at one time that the competitive dynamics between them to try to get share created an environment, where they became far more aggressive early on so I don't think the curve will look.

You know as it won't look as if.

The same as Remicade now that doesn't mean that overtime, we won't see some moderate continued erosion, but as you know for a business of our size and with the growth prospects of our business.

It's not something that.

I would inhibit our ability to be able to grow at.

You could see we grew through we ultimately had positive revenue growth in 2019. Despite the fact that we had a very significant portion of our international business you go bio similar.

In 2018.

The second question is part of the activity that we're working on now.

To a to try to drive activation at a faster rate in a in women on oral Lissa that is one component I wouldn't say, it's the most significant component, but it is one component to better educate women. What this therapy is all about.

About.

What the side effect profile of this therapy really looks like.

The safety profile of it and make sure that we do that in a way that it's easily accessible.

For women in that age group, meaning it has a social media aspect to it.

Allows.

To be able to access accurate information about oral assa and the benefits of it and the appropriate use of it and so that is part of the a of the changes that we made in the fourth bordering we're just going out to see.

How those changes the impact those changes have over time.

Thank you David.

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

Thank you and this does conclude today's conference you may disconnect at this time.