Q3 2025 AbbVie Inc Earnings Call
<unk> of this call you may ask a question by pressing star one on your phone today's call is also being recorded if you have any objections you may disconnect at this time I will now.
To introduce MS. Liz Shea Senior Vice President Investor Relations. Thank you you may begin.
Good morning, and thanks for joining US also on the call with me today are Rob My Michael Chairman and Chief Executive Officer, Jeff Stuart Executive Vice President Chief Commercial Officer, Grupo Soccer Executive Vice President Research and development, Chief Scientific Officer, and Scott rents Executive Vice President Chief Financial Officer.
Speaker #1: Good morning, and thank you for standing by. Welcome to the AbbVie third quarter 2025 earnings conference call. All participants will be able to listen only until the question and answer portion of this call.
Speaker #1: You may ask a question by pressing star one on your phone. Today's call is also being recorded. If you have any objections, you may disconnect at this time.
Before we get started I'll note that some statements. We make today may be considered forward looking statements based on our current expectations Abbvie cautions that these forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in our forward looking statements.
Speaker #1: I will now introduce Ms. LeShae, Senior Vice President and Investor Relations. Thank you. You may begin.
Speaker #2: Good morning, and thanks for joining us. Also on the call with me today are Rob Michael, Chairman and Chief Executive Officer, Jeff Stewart, Executive Vice President, Chief Commercial Officer, Roopal Thakkar, Executive Vice President, Research and Development, Chief Scientific Officer, and Scott Reents, Executive Vice President, Chief Financial Officer.
Additional information about these risks and uncertainties is included in our SEC filings Abbvie undertakes no obligation to update these forward looking statements except as required by law on today's conference call non-GAAP financial measures will be used to help investors understand abbey's business performance. These non-GAAP financial measures are reconciled with comparable GAAP financial measures in our earnings release and regular.
Speaker #2: Before we get started, I'll note that some statements we make today may be considered forward-looking statements based on our current expectations. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in our forward-looking statement.
Tori filings from today, which can be found on our website. Following our prepared remarks, we'll take your questions. So with that I'll turn the call over to Robyn. Thank you Liz good morning, everyone and thank you for joining us <unk> business continues to perform above our expectations, we delivered another excellent quarter.
Speaker #2: Additional information about these risks and uncertainties is included in our SEC filings. AbbVie undertakes no obligation to update these forward-looking statements except as required by law.
Including strong financial results pipeline advancement across all stages of development and strategic investments to drive sustainable long term growth given our positive momentum we are raising our 2025 outlook for the third time this year.
Speaker #2: On today's conference call, non-GAAP financial measures will be used to help investors understand AbbVie's business performance. These non-GAAP financial measures are reconciled with comparable GAAP financial measures in our earnings release and regulatory filings from today, which can be found on our website.
Speaker #2: Following our prepared remarks, we'll take your questions, so with that, I'll turn the call over to Rob.
Starting with our third quarter performance, we delivered adjusted earnings per share of $1.86, which is 10 cents above our guidance midpoint.
Speaker #1: Thank you, Liz. Good morning, everyone, and thank you for joining us. AbbVie's business continues to perform above our expectations. We delivered another excellent quarter.
Net revenues were nearly $15 $8 billion, reflecting high single digit sales growth and beating our expectations by approximately 300 million.
Speaker #1: Including strong financial results, pipeline advancement across all stages of development, and strategic investments to drive sustainable long-term growth. Given our positive momentum, we are raising our $2,025 outlook for the third time this year.
I'm, especially pleased with the execution of our growth platform, including combined sales growth of more than 40% from sky, Rosie and rent Voake are leading immunology medicines as well as double digit revenue growth from neuroscience, our second largest and fastest growing therapeutic.
Speaker #1: Starting with our third quarter performance, we delivered adjusted earnings per share of $1.86, which is 10 cents above our guidance midpoint. Total net revenues were nearly $15.8 billion.
Area.
With no significant LOE events in the near term our growth platform provides a clear line of sight to growth into the next decade.
Speaker #1: Reflecting high single-digit sales growth and beating our expectations by approximately 300 million. I'm especially pleased with the execution of our growth platform. Including combined sales growth of more than 40% from Skyrizzi and Rinvoq, our leading immunology medicines.
Puts abbvie in a strong position to fully invest for the 20 thirties and beyond.
Since our inception in 2013, we have invested more than $84 billion to research discover and develop new medicines and solutions for patients.
Speaker #1: As well as double-digit revenue growth from neuroscience, our second largest and fastest growing therapeutic area. With no significant LOE events in the near term, our growth platform provides a clear line of sight to growth into the next decade.
We anticipate 9 billion of adjusted R&D expense in 2025, a substantial increase from the prior year.
This supports numerous pipeline opportunities across our core areas immunology oncology neuroscience anesthetics as well as new sources of growth like obesity.
Speaker #1: This puts AbbVie in a strong position to fully invest for the 2030s and beyond. Since our inception in 2013, we have invested more than $84 billion to research, discover, and develop new medicines and solutions for patients.
More broadly I'm very pleased with the breadth and depth of our robust pipeline with approximately 90 programs across all stages of development we.
We are making excellent progress and expect several important milestones over the next two years, including new product approvals parts of App it on and payback.
Speaker #1: We anticipate $9 billion of adjusted R&D expense in 2025. A substantial increase from the prior year. This supports numerous pipeline opportunities across our core areas, immunology, oncology, neuroscience, and aesthetics.
Expanded indications for RIN book at Kimberly If you looked at <unk> and pivotal data for Lou to Kids, you map T map, a and intend to make these pipeline programs have the potential to drive growth for Abbvie later this decade.
Speaker #1: As well as new sources of growth like obesity. More broadly, I'm very pleased with the breadth and depth of our robust pipeline. With approximately 90 programs across all stages of development.
We also continue to invest in external innovation, adding novel mechanisms and platform technologies to further augment our pipeline to drive growth into 'twenty thirties and beyond our recent deal activity includes announcing the acquisition of Gilgamesh spread of silicon.
Speaker #1: We are making excellent progress and expect several important milestones over the next two years, including new product approvals for Tevapodan and PVEC, expanded indications for Rinvoq, Epkinli, Qlipta, and Ubrelvy, and pivotal data for Lutikizumab, TMAB A, and Etentamig.
Our psychiatry pipeline with a next generation psychedelic currently in phase II development for Andy D and closing the acquisition of cap stand Therapeutics further strengthening our immunology pipeline with an in vivo car T platform.
Speaker #1: These pipeline programs have the potential to drive growth for AbbVie later this decade. We also continue to invest in external innovation, adding novel mechanisms and platform technologies to further augment our pipeline to drive growth in the 2030s and beyond.
Our consistently strong performance as well as the progress we are making to build and advance a robust pipeline fully supports our capital allocation priorities.
Speaker #1: Our recent deal activity includes announcing the acquisition of Gilgamesh's Bredacilisin, expanding our psychiatry pipeline with a next-generation psychedelic currently in Phase Two development for MDD.
This includes investing at least $10 billion of capital in the U S. Over the next 10 years construction is already underway for a new API manufacturing site in north Chicago as well as expansion of biologics manufacturing and R&D capacity at our existing site in Worcester.
Speaker #1: And closing the acquisition of Capstan Therapeutics, further strengthening our immunology pipeline with an in vivo CAR-T platform. Our consistently strong performance, as well as a progress we are making to build and advance a robust pipeline, fully supports our capital allocation priorities.
We are also committed to delivering a healthy sustainable dividend that grows every year today, we announced a five 5% increase in our quarterly cash dividend beginning with the dividend payable in February 2026.
Speaker #1: This includes investing at least $10 billion of capital in the U.S. over the next 10 years. Construction is already underway for a new API manufacturing site in North Chicago.
Since inception, we have grown our quarterly dividend by more than 330%.
In summary, this is an exciting time for Abbvie, we are demonstrating outstanding execution across our portfolio and our long term outlook remains very strong with that I'll turn the call over to Jeff for additional comments on our commercial highlights Jeff.
Speaker #1: As well as expansion of biologics manufacturing and R&D capacity at our existing site in Worcester. We are also committed to delivering a healthy, sustainable dividend that grows every year.
Speaker #1: Today, we announced a $5.5% increase in our quarterly cash dividend. Beginning with a dividend payable in February 2026. Since inception, we have grown our quarterly dividend by more than 330%.
Thank you Rob I'll start with the quarterly results for immunology, which delivered total revenues of approximately $7 9 billion.
Up 11, 2% on an operational basis Sky resilient revoke continue to exceed our expectations once again, demonstrating robust growth across a broad set of indications.
Speaker #1: In summary, this is an exciting time for AbbVie. We are demonstrating outstanding execution across our portfolio. And our long-term outlook remains very strong. With that, I'll turn the call over to Jeff for additional comments on our commercial highlights.
<unk> global sales were $4 7 billion, reflecting operational growth of 46%.
Global revenues were nearly $2 2 billion up 34, 1% on an operational basis.
Speaker #1: Jeff.
I'm, especially pleased with our portfolio performance in Gastroenterology, where these two medicines are on pace to nearly double their combined sales in IBD this year.
Speaker #2: Thank you, Rob. I'll start with the quarterly results for immunology, which delivered total revenues of approximately $7.9 billion. Up 11.2% on an operational basis.
Our uptake in Crohn's disease remains impressive with Sky Rishi and revoked together achieving in play share leadership in a dozen countries. This includes capturing roughly 50% of newer switching crohns patients across all lines of therapy in the U S.
Speaker #2: Skyrizzi and Rinvoq continue to exceed our expectations, once again demonstrating robust growth across a broad set of indications. Skyrizzi, global sales were $4.7 billion, reflecting operational growth of 46%.
We see similar momentum in ulcerative colitis, as well with Sky <unk> and Renova collectively holding in play share leadership and more than 10 key markets and capturing nearly one out of every three new we're switching UC patients across all mechanisms in the U S.
Speaker #2: Rinvoq, global revenues were nearly $2.2 billion, up 34.1% on an operational basis. I'm especially pleased with our portfolio performance in gastroenterology, where these two medicines are on pace to nearly double their combined sales in IBD this year.
IBD continues to be an area of high unmet need with substantial headroom for biologic penetration as well as expanding lines of therapy.
Speaker #2: Our updating Crohn's disease remains impressive. With Skyrizzi and Rinvoq together, achieving inflation share leadership in a dozen countries. This includes capturing roughly 50% of newer switching Crohn's patients across all lines of therapy in the U.S.
Given the compelling efficacy safety and dosing profiles for both assets Sky rosy with less frequent dosing favored by patients and clinicians, especially for the maintenance treatment relative to the most effective dose for other IL 20, threes and Rainbow often preferred for difficult to treat IBD cases, having demonstrated.
Speaker #2: We see similar momentum in ulcerative colitis as well, with Skyrizzi and Rinvoq collectively holding inflation share leadership in more than 10 key markets. And capturing nearly one out of every three newer switching UC patients across all mechanisms in the U.S.
Rated the strongest response rates in UC studies.
As well as very strong efficacy and C D as well.
Speaker #2: IBD continues to be an area of high unmet need, with substantial headroom for biologic penetration, as well as expanding lines of therapy. Given the compelling efficacy, safety, and dosing profiles for both assets, Skyrizzi, with less frequent dosing favored by patients and clinicians, especially for the maintenance treatment relative to the most effective dose for other IL-23s.
Along with <unk> recently expanded label in IBD, which is a great outcome for patients who will now have access to RIN booked earlier in the treatment paradigm when anti TNF treatment is clinically and advisable.
So we remain very competitively positioned for continued strong growth across gastroenterology.
Moving to the rest of our core immunology indications <unk> continues to perform exceptionally well in psoriasis gaining share across our key markets. This includes an impressive 50% in play patient share for biologics in the U S.
Speaker #2: And Rinvoq, often preferred for difficult-to-treat IBD cases, having demonstrated the strongest response rates in UC studies, as well as very strong efficacy in CD as well.
Speaker #2: Along with Rinvoq's recently expanded label in IBD, which is a great outcome for patients who will now have access to Rinvoq earlier in the treatment paradigm when anti-TNF treatment is clinically and advisable.
<unk> is also delivering strong prescription growth in rheumatology.
In our a rainbow continues to achieve the leading in play patient share across lines of therapy. We now have three head to head studies, demonstrating <unk> superiority to other biologics NRA, including recent positive data from our select switch trial, which clearly supports the clinical benefits of switching to <unk>. After.
Speaker #2: So we remain very competitively positioned for continued strong growth across gastroenterology. Moving to the rest of our core immunology indications, Skyrizzi continues to perform exceptionally well in psoriasis, gaining share across our key markets.
Our first TNF failure.
Lastly, we are seeing a very nice ramp and GCI were invoke now has full formulary coverage I am very pleased with the progress and look forward to the commercialization of additional sizable indications like alopecia Areata and vitiligo.
Speaker #2: This includes an impressive 50% in-play patient share for biologics in the U.S. Rinvoq is also delivering strong prescription growth in rheumatology. In RA, Rinvoq continues to achieve the leading in-play patient share across lines of therapy.
Turning now to Humira, which delivered global sales of $993 million down 55, 7% on an operational basis, reflecting biosimilar competition.
Speaker #2: We now have three head-to-head studies demonstrating Rinvoq's superiority to other biologics in RA, including recent positive data from our SELECT switch trial, which clearly supports the clinical benefits of switching to Rinvoq after a first TNF failure.
We continue to anticipate Humira access in the U S will decrease throughout the remainder of this year and into 2026 as more plans select exclusionary contracts for existing patients.
Speaker #2: Lastly, we are seeing a very nice ramp in GCA, where Rinvoq now has full formulary coverage. I'm very pleased with the progress and look forward to the commercialization of additional sizable indications.
This step up in volume erosion is expected to be partially offset by a price benefit also associated with these contract changes, which is included in our fourth quarter outlook.
Speaker #2: Like alopecia areata and vitiligo. Turning now to Humira, which delivered global sales of $993 million, down 55.7% on an operational basis, reflecting biosimilar competition.
Moving to oncology, which delivered total revenues of nearly $1 7 billion relatively flat versus prior year momentum from ven cluster as well as newer products Ela here at kinley and umbrella helped to offset the expected sales decline from <unk>, which continues to be impacted by competitive dynamics in cielo.
Speaker #2: We continue to anticipate Humira access in the U.S. will decrease throughout the remainder of this year and into 2026, as more plans select exclusionary contracts for existing patients.
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Overall I'm very pleased with the progress we are making to expand our commercial capabilities in both heme and solid tumors with our existing portfolio.
Speaker #2: This step up in volume erosion is expected to be partially offset by a price benefit, also associated with these contract changes. Which is included in our fourth quarter outlook.
These efforts will ultimately support our emerging oncology pipeline, which includes several promising programs to improve patient outcomes and many difficult to treat cancers.
Speaker #2: Moving to oncology, which delivered total revenues of nearly $1.7 billion, relatively flat versus prior year. Momentum from Venclexta, as well as newer products, Elahere at Kinley and Embrelis, helped to offset the expected sales decline from Imbruvica, which continues to be impacted by competitive dynamics in CLL.
Turning now to <unk>, which delivered global sales of approximately $1 2 billion down four 2% on an operational basis.
Botox cosmetic global revenues were $637 million and Juvederm global sales were $253 million with growth rates for both products down on an operational basis.
Speaker #2: Overall, I'm very pleased with the progress we are making to expand our commercial capabilities in both heme and solid tumors with our existing portfolio.
While our portfolio is performing well from a competitive perspective, we continue to face challenging market conditions in several key markets, which are impacting our results with.
Speaker #2: These efforts were ultimately support our emerging oncology pipeline, which includes several promising programs to improve patient outcomes in many difficult-to-treat cancers. Turning now to aesthetics, which delivered global sales of approximately $1.2 billion, down 4.2% on an operational basis.
With overall consumer sentiment remain quite low, especially in the U S. As concerns about the economy and inflation way on discretionary spending we now see category growth tracking below our previous assumptions globally.
Speaker #2: Botox Cosmetic global revenues were $637 million, and Juvederm global sales were $253 million, with growth rates for both products down on an operational basis.
However, this near term macro pressure does not dampen our excitement for the long term potential of our leading aesthetics portfolio. We are investing to support patient activation with robust promotion and product innovation. We recently launched new consumer campaigns for botox as well as fillers to further stimulate category growth.
Speaker #2: While our portfolio is performing well from a competitive perspective, we continue to face challenging market conditions in several key markets, which are impacting our results.
Speaker #2: With overall consumer sentiment remaining quite low, especially in the U.S., as concerns about the economy and inflation weigh on discretionary spending, we now see category growth tracking below our previous assumptions globally.
<unk>, which remains highly underpenetrated, and where we stand to disproportionately benefit upon market recovery, giving our leading product shares.
Innovation from our pipeline, including novel toxins like trend about E. A fast acting short duration toxin as well as several next generation fillers will also provide growth in the coming years.
Moving now to neuroscience, which is demonstrating exceptional performance total revenues were more than $2 8 billion up 19, 6% on an operational basis I am very pleased with our leading migraine portfolio with you Brett Levy Q Lipton and botox therapeutic all delivering a robust double digit growth.
Q Lipton is now the number one C. G ERP treatment for migraine prevention with a total prescription share of approximately seven 5%.
<unk> is also performing well in both bipolar and a M. D D with total sales of $934 million up six 7%.
Physicians continue to report positive feedback on <unk> strong benefit risk profile, including dosing flexibility low sedation and the ability to address anhedonia and anxiety symptoms often associated with depression.
Lastly, in Parkinson's disease via loves launch trajectory has been very impressive.
<unk> sales were $138 million up 40% on a sequential basis.
The uptake across international markets continues to exceed our expectations with physicians and patient communities highlighting meaningful improvements in on time and off time from the 24 hour delivery and the control of symptoms throughout the morning day and night.
<unk> is the only Parkinson's treatment that often replaces the need for add on oral therapies to manage motor fluctuations, reducing the daily Peel pill burden for these patients.
We anticipate expanded coverage of <unk> in the U S. Soon which we expect will provide further revenue inflection next year.
I'm also excited about <unk>, where we are pursuing approval for use as a mono therapy for early Parkinson's disease as well as an adjunct to optimize oral therapy for more advanced patients. This will be a very complementary offering for both viola and dual pump.
Given the significant commercial opportunity with our emerging Parkinson's portfolio. We are now actively expanding our field sales team to support higher anticipated demand next year.
Overall again, we are demonstrating strong revenue growth and our commercial execution has been outstanding and with that I'll turn the call to ruble for comments on our R&D highlights ruble.
Thank you Jeff.
Starting with immunology, we announced positive topline results from the second phase III Rainbow Alopecia Areata trial, reinforcing the potential for <unk> to significantly improve hair regrowth for patients suffering from severe forms of this condition.
Data were consistent with the results from the first trial with revoke demonstrating meaningful improvement and hair regrowth across both doses compared to placebo we.
We remain on track to begin submitting regulatory applications later this year.
Overall, again, we are demonstrating strong revenue growth, and our commercial execution has been outstanding. With that, I'll turn the call over to Roopal for comments on our R&D highlights.
We also recently announced positive top line results from two phase III RIN volt vitiligo trials in both studies <unk> met the co primary and key secondary endpoints at week 48, demonstrating improvements in both total body and facial vitiligo, scoring compare.
Starting with immunology, we announced positive topline results from the second phase III Rainbow alopecia trial, reinforcing the potential for rainbow to significantly improve hair regrowth for patients suffering from severe forms of this condition.
Thank you, Jeff.
Data were consistent with the results from the first trial with <unk>, demonstrating meaningful improvement and hair regrowth across both doses compared to placebo we.
Starting with immunology, we announced positive topline results from the second Phase 3 Rimbaud alopecia areata trial, reinforcing the potential for Rimbaud to significantly improve hair regrowth for patients suffering from severe forms of this condition.
<unk> to placebo.
We are very pleased with these results, which illustrate <unk> potential to provide significant skin re pigmentation to patients suffering from non segmental vitiligo.
We remain on track to begin submitting regulatory applications later this year.
The daily challenges of living with this condition can often lead to depression and anxiety with.
We also recently announced positive topline results from two phase III Rainbow Vitiligo trials in both studies <unk> met the co primary and key secondary endpoints at week 48, demonstrating improvements in both total body and facial vitiligo, scoring compare.
With no approved systemic treatment there is very high unmet need for these patients.
Once approved Rainbow could potentially be the first systemic therapy available for vitiligo regulatory submissions are planned for early next year.
<unk> to placebo.
We are very pleased with these results, which illustrate <unk> potential to provide significant skin re pigmentation to patients suffering from non segmental vitiligo.
Positive top line results were also announced from the select switch trial, which compared <unk> to humira in patients who had an inadequate response or intolerant to their first TNF inhibitor.
The daily challenges of living with this condition can often lead to depression and anxiety with.
This is the first head to head study comparing anti TNF cycling versus switching to RIN vote.
With no approved systemic treatment there is very high unmet need for these patients.
In this study revoke demonstrated superiority to humira for efficacy measures with nearly twice as many patients achieving low disease activity and remission for our HAE patients who did not respond well to their first TNF inhibitor. These results clearly show the benefit of switching to revoke rather than.
Once approved Rainbow could potentially be the first systemic therapy available for vitiligo regulatory submissions are planned for early next year.
Positive top line results were also announced from the select switch trial, which compared revoke to humira in patients who had an inadequate response or intolerant to their first TNF inhibitor.
Cycling to another anti TNF.
In IBD RIN Vogue recently received a label update in Crohn's disease, and ulcerative colitis, allowing its use prior to anti TNF in patients who have received at least one approved systemic therapy.
This is the first head to head study comparing anti TNF cycling versus switching to RIN vote.
In this study revoke demonstrated superiority to humira for efficacy measures with nearly twice as many patients achieving low disease activity and remission for our HAE patients who did not respond well to their first TNF inhibitor. These results clearly show the benefit of switching to RIN book rather than.
N TNF inhibitors are clinically and advisable.
The treatment paradigm has evolved in IBD.
With increasing utilization of newer higher efficacy agents like Sky Rizzi.
There are certain clinical scenarios when an anti TNF may not be the most appropriate next treatment option for a patient. This label update provides physicians with the flexibility to use rent vote prior to anti TNF for certain patients. After they have tried another approved systemic therapy.
Cycling to another anti TNF.
In IBD RIN Vogue recently received a label update in Crohn's disease, and ulcerative colitis, allowing its use prior to anti TNF in patients who have received at least one approved systemic therapy.
Moving to oncology the regulatory application was submitted to the FDA for pivot and plastic Plasmacytoid dendritic cell neoplasm. This rare aggressive blood cancer, primarily affects an older population who is at high risk for complications with traditional chemotherapy.
TNF inhibitors are clinically and advisable.
The treatment paradigm has evolved in IBD.
With increasing utilization of newer higher efficacy agents like sky risky.
There are certain clinical scenarios when an anti TNF may not be the most appropriate next treatment option for a patient. This label update provides physicians with the flexibility to use rent vote prior to anti TNF for certain patients. After they have tried another approved systemic therapy.
European we're precluded from stem cell transplantation.
As a new treatment, providing durable responses with a manageable safety profile. Our novel ADC has the potential to become an important new therapeutic option for these patients.
Moving to oncology the regulatory application was submitted to the FDA for pivot and plastic Plasmacytoid dendritic cell neoplasm. This rare aggressive blood cancer, primarily affects an older population who is at high risk for complications with traditional chemotherapy.
At the recent ESMO meeting, we presented three oral <unk> for team mate highlighting this novel Adcs potential both as a monotherapy and in combination across advanced difficult to treat solid tumors.
European we're precluded from stem cell transplantation.
In CRC patients, who received two or more prior lines of therapy, and regardless of C met expression levels team Abbe and combination with Bevacizumab demonstrated manageable safety and better responses and disease control compared to current standard of care.
As a new treatment, providing durable responses with a manageable safety profile. Our novel ADC has the potential to become an important new therapeutic option for these patients.
At the recent ESMO meeting, we presented three oral <unk> for team Abbe, highlighting this novel Adcs potential both as a monotherapy and in combination across advanced difficult to treat solid tumors.
Treatment with <unk> at two four milligrams per kilogram plus Bevacizumab achieved an objective response rate of 30% and a confirmed disease control rate of 97% compared to rates of zero percent and 70%, respectively for Lance or plus bevacizumab.
In CRC patients, who received two or more prior lines of therapy, and regardless of C met expression levels of <unk> in combination with Bevacizumab demonstrated manageable safety and better responses and disease control compared to current standard of care.
Based on these results we plan to begin a phase III study for this combination in late line all comers CRC.
In a proof of concept study in pancreatic cancer monotherapy team Abbe demonstrated an objective response rate of 24% in the overall population and 40% in patients who received first line Gemcitabine plus a vaccine.
Treatment with <unk> at two four milligrams per kilogram plus Bevacizumab achieved an objective response rate of 30% and a confirmed disease control rate of 97% compared to rates of zero percent and 70% respectively for <unk> plus bevacizumab.
A phase II study in pancreatic cancer is expected to begin next year.
And in an exploratory study in met amplified solid tumors. After progression following standard of care monotherapy with team Abbe resulted in an objective response rate of 47% and median duration of response of 12 and a half months for the two four milligram.
Based on these results we plan to begin a phase III study for this combination in late line all comers CRC.
In a proof of concept study in pancreatic cancer monotherapy team Abbe demonstrated an objective response rate of 24% in the overall population and 40% in patients who received first line Gemcitabine plus a vaccine.
Rand per kilogram dose higher responses were observed in patients with non small cell lung cancer with a rate of 69% and gastroesophageal cancer with a rate of 71%.
A phase II study in pancreatic cancer is expected to begin next year.
Phase III study in met amplified solid tumors is expected to begin later this year.
And in an exploratory study in met amplified solid tumors. After progression following standard of care monotherapy with <unk> resulted in an objective response rate of 47% and median duration of response of 12 and a half months for the two four milligram.
We are making significant progress with team member across a broad range of tumors and there is an increasing body of evidence demonstrating durable efficacy and a manageable safety profile in these difficult to treat cancers, we look forward to providing additional updates on <unk> programs as data mature.
On a per kilogram dose higher responses were observed in patients with non small cell lung cancer with a rate of 69% and gastroesophageal cancer, where the rate of 71%.
Sure.
In neuroscience, the regulatory application for it to vapor done in Parkinson's disease was recently submitted to the FDA for many patients with Parkinson's existing oral therapies aren't sufficient to manage symptoms.
Phase II study and met amplified solid tumors is expected to begin later this year.
We are making significant progress with <unk> across a broad range of tumors and there is an increasing body of evidence demonstrating durable efficacy and a manageable safety profile in these difficult to treat cancers, we look forward to providing additional updates on PMMA programs as data mature.
Our selective D. One D. Five receptor partial agonist demonstrated robust efficacy as a monotherapy in early Parkinson's disease, and as an adjunct to levo carpet dopo oral therapy and patients still experiencing motor fluctuations once approved we believe.
Sure.
In neuroscience, the regulatory application for <unk> in Parkinson's disease was recently submitted to the FDA for many patients with Parkinson's existing oral therapies aren't sufficient to manage symptoms.
<unk> will be an important new treatment option.
Results from a phase II study evaluating botox and upper limb essential tremor were recently presented at the M. D. S Congress.
Our selective D. One D. Five receptor partial agonist demonstrated robust efficacy as a monotherapy in early Parkinson's disease, and as an adjunct to legal carpet dopo oral therapy and patients still experiencing motor fluctuations once approved we believe.
In this study botox met the primary and all secondary endpoints demonstrating significant improvement in all assessment measures compared to placebo.
With a global patient population of about $25 million essential tremor is the most common movement disorder. This progressive neurological condition can substantially hinder patients' physical activities and diminish their quality of life.
<unk> will be an important new treatment option.
Results from a phase II study evaluating botox and upper limb essential tremor were recently presented at the Mds Congress.
Current treatment options are limited in terms of both efficacy and tolerability, leaving considerable need for new therapies.
In this study botox met the primary and all secondary endpoints demonstrating significant improvements in all assessment measures compared to placebo.
Based on these results we plan to advance a new toxin for upper limb essential tremor.
<unk> is a novel toxin that is demonstrated different pharmacologic properties pre clinically compared to botox, such as less diffusion to neighboring muscles.
With a global patient population of about $25 million essential tremor is the most common movement disorder. This progressive neurological condition can substantially hinder patients' physical activities and diminish their quality of life.
Two studies for Jimmy body in essential tremor, and ventral hernia repair will begin next year.
Current treatment options are limited in terms of both efficacy and tolerability.
Yeah.
To further expand our neuropsychiatry pipeline, we acquired we acquired Bret Silicon from Gilgamesh Greta citizen as a novel five H T. Two <unk> receptor agonist and five H T releaser with a short duration of hallucination that has demonstrated robust.
Leaving considerable need for new therapies.
Based on these results we plan to advance a new toxin for upper limb essential tremor.
<unk> is a novel toxin that is demonstrated different pharmacologic properties pre clinically compared to botox, such as less diffusion to neighboring muscles.
Efficacy in a phase II proof of concept study in major depressive disorder.
Phase II studies for Jimmy body in essential tremor, and ventral hernia repair will begin next year.
Rapid efficacy was achieved after the initial dose with response and remission maintained through day 74.
Additional intervention. This novel psychedelic has the potential to provide significant benefit to patients by offering rapid robust and durable anti depressant effect following a short in clinic treatment session.
To further expand our neuro psychiatry pipeline, we acquired we acquired Bret Silicon from Gilgamesh credit Silicon as a novel five H T. Two <unk> receptor agonist and five H T releaser with a short duration of hallucination.
Additional phase II studies in depression are expected to begin next year.
As demonstrated robust efficacy in a phase two proof of concept study in major depressive disorder.
To summarize we continue to make good progress across all stages and therapeutic areas of our pipeline and look forward to many important pipeline milestones in the remainder of this year and into 2026.
Rapid efficacy was achieved after the initial dose.
With response and remission maintained through day 74 without additional intervention. This novel psychedelic has the potential to provide significant benefit to patients by offering rapid robust and durable anti depressant effect following a short in clinic treatment session.
With that I'll talk I'll turn the call over to Scott.
Yeah.
Thank you ripple.
Starting with our third quarter results, we reported adjusted earnings per share of $1 86.
Additional phase II studies in depression are expected to begin next year.
Which is 10 cents above our guidance midpoint.
These results include a $1 50 unfavorable impact from acquired IP R&D expense, primarily reflecting upfront charges for the acquisition of Capstone Therapeutics and our license agreement with Agi.
To summarize we continue to make good progress across all stages and therapeutic areas of our pipeline and look forward to many important pipeline milestones in the remainder of this year and into 2026.
Total net revenues were nearly $15 8 billion.
With that I'll talk I'll turn the call over to Scott.
Reflecting growth of eight 4% on an operational basis.
Yeah.
Thank you ripple.
Excluding a modestly favorable impact from foreign exchange.
Starting with our third quarter results, we reported adjusted earnings per share of $1 86.
Importantly, our ex Humira growth platform delivered reported sales growth of more than 20%.
Which is 10 cents above our guidance midpoint.
Once again exceeding our expectations.
These results include a $1 50 unfavorable impact from acquired IP R&D expense, primarily reflecting upfront charges for the acquisition of Capstone Therapeutics and our license agreement with Iga.
Adjusted gross margin was 83, 9% of sales adjusted R&D expense was 14, 3% of sales and adjusted SG&A expense was 21, 6% of sales.
Total net revenues were nearly $15 8 billion, reflecting growth of eight 4% on an operational basis, excluding a modestly favorable impact from foreign exchange.
Adjusted operating margin ratio was 39% of sales, which includes a 17% unfavorable impact from acquired IP R&D expense.
Importantly, our ex Humira growth platform delivered reported sales growth of more than 20% once again exceeding our expectations.
Net interest expense was $667 million the adjusted tax rate was 24, 5%, reflecting the lower deductibility of acquired IP R&D expense this quarter.
Adjusted gross margin was 83, 9% of sales adjusted R&D expense was 14, 3% of sales and adjusted SG&A expense was 21, 6% of sales.
Turning to our financial outlook, we are raising our full year adjusted earnings per share guidance to between $10.61.
The adjusted operating margin ratio was 39% of sales, which includes a 17% unfavorable impact from acquired IP R&D expense.
And $10 and 65 sips.
Please note that this guidance does not include an estimate for acquired IP R&D expense that may be incurred beyond the third quarter.
Net interest expense was $667 million.
We now expect total net revenues of approximately $69 billion, an increase of $400 million.
Adjusted tax rate was 24, 5%, reflecting the lower deductibility of acquired IP R&D expense this quarter.
This updated forecast primarily reflects.
Sky Ritchie global sales of $17 3 billion.
Turning to our financial outlook, we are raising our full year adjusted earnings per share guidance to between $10.61.
An increase of $200 million with continued share gains in psoriasis and IBD.
And $10 65 sips.
Neuroscience global revenues of $10 7 billion, an increase of $200 million, reflecting continued strength across graybar botox therapeutic via live and the total oral C. G ERP portfolio.
Please note that this guidance does not include an estimate for acquired IP R&D expense.
<unk> incurred beyond the third quarter.
We now expect total net revenues of approximately $69 billion.
<unk> total sales of $4 9 billion, a decrease of $200 million, reflecting greater than expected market softness globally.
An increase of $400 million.
This updated forecast primarily reflects.
Sky Ritchie global sales of $17 3 billion.
With the remaining $200 million increase reflecting the collective momentum from revoke and several other products across our diverse portfolio.
An increase of $200 million with continued share gains in psoriasis and IBD.
Neuroscience global revenues of $10 7 billion, an increase of $200 million, reflecting continued strength across graybar botox therapeutic via live and the total oral C. G ERP portfolio.
And we also continue to assume a relatively neutral impact from foreign exchange on full year sales growth.
Moving to the P&L for full year 2025.
We continue to expect adjusted gross margin of 84% of sales.
Our statics total sales of $4 9 billion, a decrease of $200 million, reflecting greater than expected market softness globally.
Adjusted R&D expense of $9 billion.
And adjusted SG&A expense of $13 $5 billion.
With the remaining $200 million increase reflecting the collective momentum from revoke and several other products across our diverse portfolio.
We now anticipate an adjusted operating margin ratio of approximately 41% of sales.
In line with our previous expectations after including the roughly 6% unfavorable impact of acquired IP R&D expense incurred through the third quarter.
And we also continue to assume a relatively neutral impact from foreign exchange on full year sales growth.
Moving to the P&L for full year 2025, we continue to expect adjusted gross margin of 84% of sales.
And we now forecast our non-GAAP tax rate to be approximately 17, 3% also reflecting the impact of acquired IP R&D.
Adjusted R&D expense of $9 billion and.
And adjusted SG&A expense of $13 $5 billion.
Turning to the fourth quarter, we anticipate net revenues of more than $16 $3 billion.
We now anticipate an adjusted operating margin ratio of approximately 41% of sales.
This reflects an estimated 1% favorable impact from foreign exchange on sales growth.
In line with our previous expectations after including the roughly 6% unfavorable impact of acquired IP R&D expense incurred through the third quarter.
We expect adjusted earnings per share between $3 32 and.
And $3.36.
This guidance does not include acquired IP R&D expense that may be incurred in the quarter.
And we now forecast our non-GAAP tax rate to be approximately 17, 3% also reflecting the impact of acquired IP R&D.
Finally, abbvie is robust business performance continues to support our capital allocation priorities.
Turning to the fourth quarter.
Our cash balance at the end of September was more than $5 6 billion.
We anticipate net revenues of more than 16 $3 billion.
And we generated approximately $13 billion of free cash flow in the first nine months of the year.
This reflects an estimated 1% favorable impact from foreign exchange on sales growth.
Which includes nearly $2 $2 billion of Sky rosy royalty payments.
We expect adjusted earnings per share between $3 32 and.
This free cash flow fully supports.
And $3.36.
Our strong and growing quarterly dividend, which we are increasing five 5% to $1 73 per share.
This guidance does not include acquired IP R&D expense that may be incurred in the quarter.
Finally, abbvie is robust business performance continues to support our capital allocation priorities.
Getting with the dividend payable in February 2026.
As well as capacity for continued business development.
Our cash balance at the end of September was more than $5 6 billion.
We have executed approximately 30 deals since the beginning of 2024, and we continue to assess external innovation across all of our key growth areas.
And we generated approximately $13 billion of free cash flow in the first nine months of the year.
We also remain on track to achieve a net leverage ratio of two times by the end of 2026.
Which includes nearly $2 $2 billion of Sky rosy royalty payments.
This free cash flow fully supports.
In closing Abbvie once again delivered outstanding results and our financial outlook remains very strong.
Our strong and growing quarterly dividend, which we are increasing five 5% to $1 73 per share.
With that I'll turn the call back over to Liz. Thanks, Scott We will now open the call for question in the interest of hearing from as many analysts as possible over the remainder of the call. We ask that you. Please limit your questions to one or two Cedric will take the first question. Please.
Beginning with the dividend payable in February 2026.
As well as capacity for continued business development.
We have executed approximately 30 deals since the beginning of 2024, and we've continued to assess external innovation across all of our key growth areas.
Yes. My first question comes from Terence Flynn with Morgan Stanley. Your line is open.
We also remain on track to achieve a net leverage ratio of two times by the end of 2026.
Great. Thanks, so much congrats on the quarter.
Two for me I guess, the first is just Rob would love your perspective on the potential implications for your business or the new.
In closing Abbvie once again delivered outstanding results and our financial outlook remains very strong.
<unk> model that Sigma discussed on their earnings call.
With that I'll turn the call back over to Liz. Thanks.
Yesterday, I believe and then IRA price negotiations recently concluded and just wondering if you're able to comment at all on how.
Thanks, Scott we will now open the call for question in the interest of hearing from as many analysts as possible over the remainder of the call. We ask that you. Please limit your questions to one or two.
Those went for <unk> and Linzess. Thank you.
<unk> will take the first question please.
Thanks terrorists. So this is Rob I'll start with your first question, we have actually Jeff supplement as well.
Yes. My first question comes from Terence Flynn with Morgan Stanley. Your line is open.
Great. Thanks, so much congrats on the quarter.
But I think one thing that's important to think about as it relates to whether it's you know PVM reform.
Two for me I guess, the first is just Rob would love your perspective on the potential implications for your business or the new.
Questions. We've got on DTC also what drives <unk> performance is our differentiated medicines, along with our execution track record and strong culture and that's why we deliver similar strong performance in markets outside the U S, where pbms and DTC do not play a role so now given our ability to execute we are very good.
<unk> model that Sigma discussed on their earnings call.
Yesterday, I believe and then IRA price negotiations recently concluded and just wondering if you're able to comment at all on how those went for <unk> and Linzess. Thank you.
Utilizing the tools that are available to us if there are changes to the <unk> model, we will certainly be able to adapt effectively I mean, I think for us as we think about it. The key is to continue developing differentiated medicines is that is what delivers real value and can drive growth in any environment and I'll, let Jeff Jeff speak more specifically to how we see the P. P M model playing out.
Thanks terrorists. So this is Rob I'll start with your first question, we have actually Jeff supplement as well.
But I think one thing that's important to think about as it relates to whether its PVM reform.
Questions. We've got on DTC also what drives abbey's performance is our differentiated medicines, along with our execution track record and strong culture and that's why we deliver similar strong performance in markets outside the U S, where pbms and DTC do not play a role so now given our ability to execute we are very good at.
Yeah, Thanks Robin and.
Just to sort of reiterate this approach I mean, if you think about some of these announcements over the years, whether its rebate pass through where there is existing networks like this that that work today and we think there's a lot of merit to that like the ability for patients to share in lowering their their out of pocket costs at the counter is a good approach there's been a lot of.
Utilizing the tools that are available to us if there are changes to the <unk> model, we will certainly be able to adapt effectively I think for us as we think about it. The key is to continue developing differentiated medicines as data is what delivers real value and can drive growth in any environment and I'll, let Jeff Jeff speak more specifically to how we see the P. P M model playing out.
Structural barriers to that of course over the years, sometimes it's the clients don't really have the incentive to go in <unk> based on how they are using those rebates.
Maybe to lower premiums we all we all know those stories I think the key point is rob's point that across my global footprints, we're used to dealing with any type of approach whether it's a net price market is.
Yeah, Thanks Robin and.
Just to sort of reiterate this approach I mean, if you think about some of these announcements over the years, whether its rebate pass through where there is existing it looks like this that that work today and we think there's a lot of merit to that like the ability for patients to share in lowering their their out of pocket costs at the counter is a good approach there's been a lot of <unk>.
Rebate driven market or a hybrid market, that's net price and rebate like Germany.
Or HCA markets. So, we're very very adaptable to sort of any sort of structure because we rely on the distinctiveness of our brands and when we position those in the right way, which we always do we.
Structural barriers to that of course over the years, sometimes it's the clients don't really have the incentive to go in based on how they are using those rebates maybe to lower premiums. We all we all know those stories I think the key point is rob's point that across my global footprint, we're used to dealing with any type of.
We perform exceptionally well from a market share in a competitive perspective. So we will continue we don't know a lot of the details, but we talked to signal all the time our account teams talk we talk at the executive level. So we will continue to study it but we're very confident in terms of.
<unk> approach, whether it's a net price market, it's a rebate driven market or a hybrid market, that's net price and rebate like Germany.
What are the changes in the model, we would adapt very well and Terence. This is Rob again on your question regarding Iras that prices are obviously, not yet public, but I will say that the administration's focus on achieving greater reductions in this year's round was very clear that said the outcomes for <unk> Linzess will not impact our long term guidance.
Or HCA markets. So, we're very very adaptable to sort of any sort of structure because we rely on the distinctiveness of our brands and when we position those in the right way, which we always do.
We perform exceptionally well from a market share in a competitive perspective. So we will continue we don't know a lot of the details, but we talked to signal all the time our account teams talk we talk at the executive level. So we will continue to study it but we're very confident in terms of.
Thanks, Karen Operator next question please.
Yes. Our next question comes from Chris Schott with Jpmorgan. Your line is open.
Okay, great. Thanks, so much.
Love, a little bit more of a discussion on the IL 23 market, obviously sky Rajiv doing really well here, but just with the <unk> sub Q injection dosing kind of rolling out what are you seeing in terms of competitive dynamics and positioning and how do you see kind of the dynamics between those you and that you and your nearest competitor kind of evolving over time and then my second.
Where the changes in the DJ.
The model, we would adapt very well and Terence. This is Rob again on your question regarding IRI. The prices are obviously, not yet public, but I would say that the administration's focus on achieving greater reductions in this year's round was very clear.
That said the outcomes for rail islands, Linzess will not impact our long term guidance.
Western is just any initial look on 2026 do you think about the various pushes and pulls in the business and anything in particular, you think the street isn't properly accounting for as we think about the outlook for next year. Thank you.
Thanks, Karen Operator next question please.
Yes. Our next question comes from Chris Schott with Jpmorgan. Your line is open.
Okay, great. Thanks, so much.
Yeah, Hi, Chris It's Geoff I'll take your first question. So yes. We are we are very pleased with Sky Ridge. These growth overall and in the quarter I mean, 46% year over year is quite strong. So we see that momentum had share gains it's market growth and we retain a very very strong in play share position in IBD its really a leader.
Love, a little bit more of a discussion on the IL 23 market, obviously sky Rajiv doing really well here, but just with the <unk> sub Q induction dosing kind of rolling out what are you seeing in terms of competitive dynamics and positioning and how do you see kind of the dynamics between those you and that you and your nearest competitor kind of evolving over time and then my second.
<unk> position.
What we do see is we know that <unk> is going to gain some market share and in play share, but what's actually happening is the category are the class of IL 20, threes is expanding incredibly rapidly.
Question is just any initial look on 2026 do you think about the various pushes and pulls in the business and anything in particular, you think the street isn't properly accounting for as we think about the outlook for next year. Thank you.
And we view this as a positive we said before this is not a zero sum game, we're very confident in our competitive position I'll give you a little bit of some numbers are more some more recent numbers to see how dramatic disease. So just over a year ago when the IL 23.
Yeah, Hi, Chris It's Geoff I'll take your first question. So yes. We are we are very pleased with Sky Ridge. These growth overall and in the quarter I mean, 46% year over year is quite strong so and we see that momentum had share gains it's market growth and we retain a very very strong in play share position in IBD its really a lead.
We're entering.
The MBR at share for you see this as ulcerative colitis, which is the smaller of the two was around 5% that was the penetration rate now it's approaching in this latest quarter close to 40. So this is a dramatic change in the adoption of the IL 20, threes Sky risky continues to grow from fire will grow theirs.
<unk> position, what we do see is we know that <unk> is going to gain some market share and in play share, but what's actually happening is the category are the class of IL 20, threes is expanding incredibly rapidly.
And we view this as a positive we said before this is not a zero sum game, we're very confident in our competitive position I'll give you a little bit of some numbers are more some more recent numbers to see how dramatic disease.
Yes, there are subtle differences, but we're super confident in where this this product will go. So <unk> is performing very very well and we will continue to do do so and don't forget it's just not a scott.
So just over a year ago, when the IL 23.
Scott really story Abbvie has uniquely sort of a one two punch in this market, we got sky <unk> and Rainbow.
We're entering.
The MBR at share for you see this as ulcerative colitis, which is the smaller of the two was around 5% that was the penetration rate now it's approaching in this latest quarter close to 40. So this is a dramatic change in the adoption of the IL 20, threes Sky risky continues to grow from fire will grow.
As I mentioned in my prepared remark our position with Rainbow just got significantly stronger for gastro neurologist in patients with that enhanced indication. So what that allows us to do is that physicians if they if they choose it if someone is not eligible or it's an advisable clinically for TNF you can go right to Rainbow so its a re.
There is yes, there are subtle differences, but we're super confident in where this this product will go. So <unk> is performing very very well and we will continue to do do so and don't forget it's just not it.
Really really powerful position and set up for for Abbvie right now and over time. So that's basically what we're observing in the in the marketplace and Chris ruble for subcutaneous for Sky Reserve, we'll see data next year for our own induction and then that plus IV still leads to every <unk>.
Scott Ritchie story, Abbvie has uniquely sort of a one two punch in this market, we got Sky <unk> and RIN book and as I mentioned in my prepared remark our position with Rainbow just got significantly stronger for gastro neurologist in patients with that enhanced indication. So what that allows us to do is that physicians if they if they.
Eight week dosing, which continues to be a major advantage.
And Chris This is Rob regarding your question on 2026, our business continues to perform exceptionally well we've raised our revenue forecast this year by nearly $2 billion since our initial guidance in February and that's not just coming from Sky Roseann Rainbow, we're seeing over performance across the entire neuroscience portfolio and oncology is ahead.
<unk> if someone is not eligible or it's an advisable clinically for TNF you can go right to Rainbow. So it's a really really powerful position and set up for for Abbvie right now and over time. So that's basically what we're observing in the are in the marketplace and Chris ruble for subcutaneous for Sky risen.
Our original guidance as well that momentum should allow us to deliver strong growth next year. Despite headwinds from continued humira erosion and <unk> on IAA pricing.
You will see data next year for our own induction and then that plus IV still leads to every eight week dosing, which continues to be a major advantage.
Call that <unk> negotiated and that pricing will kick in next year.
Humira erosion will continue, albeit not at the same absolute level as we saw in 2025, well when I think about just the growth platform in particular, obviously a lot of attention is placed on sky roseann revoke appropriately but in neuroscience. When you think about the performance of rail or migraine franchise.
Chris This is Rob regarding your question on 2026, our business continues to perform exceptionally well we've raised our revenue forecast this year by nearly $2 billion since our initial guidance in February and that's not just coming from Sky Roseann rent vote, we're seeing over performance across the entire neuroscience portfolio and oncology is ahead of us.
Inclusive of Botox therapeutic which is a little bit over 40% of that business is for chronic migraine and then <unk>, we're just seeing tremendous ramps.
The guidance as well that momentum should allow us to deliver strong growth next year. Despite headwinds from continued humira erosion and <unk> on IAA pricing recall that <unk> negotiated and that pricing will kick in next year.
And we're also starting to now see as Jeff mentioned, we expect the any inflection, particularly with the U S. We've seen some nice progress there, but I would say that'll be a very nice growth driver for us in 2026, and so we're very pleased with the performance. Obviously clearly the momentum is there we've now beating and raising every quarter.
And Humira erosion will continue, albeit not at the same absolute level.
As we saw in 2025, well when I think about just the growth platform in particular, obviously a lot of attention is placed on sky roseann revoke appropriately but in neuroscience. So when you think about the performance of rail or migraine franchise inclusive of botox therapeutic, which you know a little bit.
25 and of course, it will provide specific guidance for 26 on the fourth quarter call.
Thanks, Chris Operator next question please.
Yes. Our next question comes from <unk> <unk> with Guggenheim Securities. Your line is open.
Over 40% of that business is for chronic migraine and then via Lev, We're just seeing tremendous ramps.
Great. Thank you for taking my questions two if I could one just Ron thanks for the commentary when he violent and I was wondering.
And we're also starting to now see as Jeff mentioned, we expect the inflection, particularly with the U S. We've seen some nice progress there, but I would say that it'll be a very nice growth driver for us in 2026, and so we're very pleased with the performance. Obviously clearly the momentum is there we have now beaten raise it every quarter of 25.
My question thinking around the guidance, you've given for everything remotely.
Could you be clearly on track to exceed that I'm curious your thoughts around updating the season.
Longer term outlook.
Leveraging rainbow.
And then the other question is on the aesthetics side can you just comment on the latest market share since you have the boat will Tompkins give again.
And of course, it will provide specific guidance for 26 on the fourth quarter call.
Thanks, Chris Operator next question please.
Thank you.
Yes. Our next question comes from <unk> <unk> with Guggenheim Securities. Your line is open.
Obama this is Rob I'll take your first question so.
As you recall, we updated our 2027 guidance for Sky Roseann Rainbow during the Q4 call earlier this year and since then we have raised our combined guidance for 2025 by over $1 7 billion. So it's reasonable to assume that we will exceed that long term guidance and I think that will be very clear when we provide two.
Great. Thank you for taking my questions I have two if I could one just Ron thanks for the commentary when you buy them and I was wondering I mean my.
My question is on the guidance you've given for everything resolved before you can really clearly on track to exceed that I'm curious your thoughts around updating the freedom to your longer term outlook for Scott Richardson.
26 guidance on the upcoming Q4 call now we have provided long term guidance in the past really to help investors understand what the company will look like on the other side of the Humira LOE event. We said, we would rapidly return to robust growth and deliver high single digit compound revenue growth from 24 to 29, and we gave product specifics.
And then the other question is on the aesthetic side can you just comment on the latest market share since you have the ball.
Thank you again.
Thank you.
Obama this is Rob I'll take your first question so.
As you recall, we updated 2027 guidance for Sky resumed Rainbow during the Q4 call earlier this year and since then we have raised our combined guidance for 2025 by over $1 7 billion. So it's reasonable to assume that we will exceed that long term guidance and I think that will be very clear when we provide two.
To support that high single digit growth outlook, I mean sitting here today, we have clearly demonstrated the rapid return to growth our 2025 sales outlook exceeds our previous peak by almost $3 billion and thats within two years of the LOE events.
26 guidance on the upcoming Q4 call.
And the Street now reflects our high single digit growth outlook for this decade, I'd say there appears to be good recognition of our momentum with sky resumed revoke though they do continue to perform above our own expectations and there's recognition that our diversified growth platform can drive top tier performance that said there are a few things that remains underappreciated.
Now we have provided long term guidance in the past really to help investors understand what the company will look like on the other side of the Humira LOE event. We said, we would rapidly return to robust growth and deliver high single digit compound revenue growth from 24 to 29, and we gave product specifics to support that high single digit growth outlook I mean sitting here today.
One is our strategy to continue innovating in immunology and drive growth beyond Sky Roseann rental both in terms of combination approaches with sky rosy or invoke as a backbone and through new platforms, such as oral peptides and b cell depletion approaches.
We have clearly demonstrated the rapid return to growth our 2025 sales outlook exceeds our previous peak by almost $3 billion and thats within two years of the LOE events.
And the Street now reflects our high single digit growth outlook for this decade, I'd say there appears to be good recognition of our momentum with Sky Regina invoke though they do continue to perform above our own expectations and there's recognition that our diversified growth platform can drive top tier performance that said there are a few things that remain underappreciated.
Also have looted kizziah mapping of our pipeline we have <unk>, we have a trump one antibody. So I think there's quite a bit of depth here in immunology pipeline that can set us up to grow beyond sky resumed Rainbow and I don't think that's that's always appreciate it. We also do not see enough investor focus on our neuroscience franchise, it's increased but it's still not at the level that I think it.
One is our strategy to continue innovating in immunology and drive growth beyond Sky Roseann rental both in terms of combination approaches with sky rosy or invoke as a backbone and through new platforms, such as oral peptides and b cell depletion approaches.
Should be given it's our second largest therapeutic area and the fastest growing in our portfolio. We have very strong positions in psych in migraine and an emerging leadership position in Parkinson's with Biola antivax it on.
We also have an opportunity to transform care for essential tremor.
Also have Lou to Kiss your map in our pipeline, we have <unk>, we have a trump one antibody. So I think there's quite a bit of depth here in the immunology pipeline that can set us up to grow beyond <unk> and I don't think that's that's always appreciate it. We also do not see enough investor focus on our neuroscience franchise. It has increased but it's still not at the level that I think it.
Liana platform also gives us the potential to advance alzheimers treatment and our Gilligan Bastian Gedeon Richter deals give us more depth in mood disorders stay at the same time, we are starting to see more attention on our oncology pipeline, including <unk> in several solid tumors and cancer, Meg and multiple myeloma 706 in small cell lung cancer as well as the <unk>.
Should be given it's our second largest therapeutic area and the fastest growing in our portfolio. We have very strong positions in psych in migraine and an emerging leadership position in Parkinson's with Biola antivax it on.
Recent BD transactions for <unk> specific antibodies from sincere ni Gi and given our clear runway to growth into the next decade. We are in a very strong position to continue increasing our R&D investment in acquiring more external innovation that can help drive long term growth. So to me it's more important to investors appreciate the depth of our pipe.
We also have an opportunity to transform care for essential tremor.
Liana platform also gives us the potential to advance alzheimers treatment and our Gilligan bashing Gedeon Richter deals give us more depth in mood disorders and stay at the same time, we are starting to see more attention on our oncology pipeline, including T map <unk> and several solid tumors and <unk> in multiple myeloma 706 in small cell lung cancer as well as the <unk>.
Your line that can drive growth in the next decade versus updating financial guidance again for this decade.
And bundle, it's Jeff I'll, just give you some of the since you asked about the dynamics in the in the U S with the aesthetics. So.
It really does start with the market. If you look at that if you look at the U S toxin market, it's really flattish position in the U S. The filler market has been problematic it's been down double digits. When you look at our share what we can see is that year over year. We are lower than we were last year because of the alley re imagine but.
Recent BD transactions for <unk> specific antibodies from sincere and agi and given our clear runway to growth into the next decade. We are in a very strong position to continue increasing our R&D investment in acquiring more external innovation that can help drive long term growth. So to me it's more important to investors appreciate the depth of our pipe.
<unk>, we're growing so we sit in the low sixty's in terms of botox share and Thats, a clear leadership position.
<unk> that can drive growth in the next decade versus updating financial guidance again for this decade.
And bomber, which Jeff I'll, just give you some of the since you asked about the dynamics in the in the U S with aesthetics. So.
By a large margin in the U S. When you look at the H a filler generally that's in the mid <unk> call. It 45% and that's largely been very stable. So that gives you some sense of of the dynamics. The big thing is as the leader we have to invest and we are investing in the market as I mentioned in my remarks, we have a significant botox consumer camp.
It really is just to start with the market. If you look at that if you look at the U S toxin market, it's really flattish position in the U S. The filler market has been problematic it's been down double digits. When you look at our share what we can see is that year over year. We are lower than we were last year because of the alley re imagine but.
Pain, that's in the market, we're starting to see some nice pick up there. So we're encouraged we have a.
H a filler sentiment campaign to make sure that we're working with all of our clinics to make sure we can revitalize and get that market stabilized and more robust because you really do need a ha fillers to really get the aesthetics outcomes. So we believe we can rehabilitate that segment and we also have opened three very significant training in sort of practice growth.
<unk>, we're growing so we sit in the low sixty's in terms of botox share and Thats, a clear leadership position.
By a large margin in the U S. When you look at the H a filler generally that's in the mid <unk> call. It 45% and that's largely been very stable. So that gives you some sense of of the dynamics. The big thing is as the leader we have to invest and we are investing in the market as I mentioned in my remarks, we have a significant botox consumer camp.
<unk> around the country to continue to lead that marketplace. So that gives you a sense of the metrics that you were asking for it.
Thanks, Rommel operator next question please.
Pain, that's in the market, we're starting to see some nice pick up there. So we're encouraged we have.
Our next question comes from Matt Phipps with William Blair. Your line is open.
H a filler sentiment campaign to make sure that we're working with all of our clinics to make sure we can revitalize and get that market stabilized and more robust because you really do need a ha fillers to really get the aesthetics outcomes. So we believe we can rehabilitate that segment and we also have opened three very significant training and sort of Pratt.
Alright, Thanks for taking my question congrats on another great quarter.
Mr. Aaron just to close I Wonder if you could give us any details on how you might design future studies, especially around the use of a low dose active control maybe how you see this fitting into the overall ended in treatment paradigm given the in clinic administration.
This growth centers around the country to continue to lead that marketplace. So that gives you a sense of the metrics that you were asking for.
Yes.
Yes, Thanks, Matt it's rupal.
We're very excited about this our approach with other other psychedelics they tend to have a very long tail, especially around hallucination.
Thanks, Pamela operator next question please.
Our next question comes from Matt Phipps with William Blair. Your line is open.
Alright, Thanks for taking my question congrats on another great quarter.
This one has a very short duration so when its in clinic it will be a short duration and a lot of clinicians.
Gilgamesh exercise clothes I wonder if you could give us any details on how you might design future studies, especially around the use of a low dose active control maybe how do you see this fitting into the overall ended in treatment paradigm given the in clinic administration.
Our prepared to do this.
Already so we're not worried about.
Having that being a barrier for uptake there is so much.
Depression, an unmet need we think that Ah patients and.
Yes, Thanks, Matt it's rupal.
We're very excited about this our approach with other other psychedelics they tend to have a very long tail, especially around hallucination.
Caregivers would really like more options like this one the other benefit that we saw as a longer duration. After just one or two doses.
And this one has a very short duration. So when its in clinic it will be a short duration and a lot of clinicians.
That maybe speaks to this potential concept of rewiring so there.
Excited about that so the key for US is in depression looking at different doses and looking at different duration paradigms and we're going to do that in phase III and ultimately move into phase III.
Our prepared to do this.
Already so we're not worried about it.
Having that being a barrier for uptake there is so much.
Depression, an unmet need we think that Ah.
There is this a regulatory need for a low dose comparator and thats because of the potential unwinding.
Patients and caregivers with really like more options like this one the other benefit that we saw is a longer duration. After just one or two doses.
And the phase III study that we've let gilgamesh is already posted was against a low dose comparator and you saw those very large deltas. So that's what we're excited about and we think there's opportunities in different lines of depression and potentially other.
That maybe speaks to this potential concept of rewiring so there.
Excited about that so the key for US is in depression looking at different doses and looking at different duration paradigms and we're going to do that in phase III and ultimately move into phase III.
Mood disorders that we're going to investigate to go beyond just major depression.
Thanks, Matt Operator next question please.
There is this a regulatory need for a low dose comparator and that's because of the potential unwinding.
Our next question comes from David as long with Piper Sandler Your line is open.
Yeah.
So I wanted to drill down on your Parkinson's franchise can.
And the phase III study that we've let gilgamesh is already posted was against the low dose comparator and you saw those very large deltas. So that's what we're excited about and we think there's opportunities in different lines of depression and potentially other.
Can you talk to.
Like of the olive and specifically.
What are you, saying regarding competitive dynamics, given the availability of an <unk>.
So that's number one and then on <unk>, which you've talked about increasingly you've got adjunctive therapy and also a monotherapy here so pretty versatile but.
Mood disorders that we're going to investigate to go beyond just major depression.
Also bearing in mind that with oral therapies.
Thanks, Matt Operator next question please.
Highly genericize. So how are you thinking about.
Our next question comes from David as long with Piper Sandler Your line is open.
Sales potential there and ultimately where you see your role in practice for to rapid done. Thank you.
Yeah.
So I wanted to drill down on your Parkinson's franchise can.
Yes. Thanks for the question I'll start off and then turn it over to ruble.
Can you talk to.
Take of the olive and specifically.
So as Robin I mentioned, we're very very pleased with via <unk> around the around the world with sales ramping very very nicely and you know it is levodopa carbon delta. So it is the gold standard is just the ability to get that in the sub Q version.
What are you seeing regarding competitive dynamics, given the availability of an <unk>.
So that's number one and then on <unk>, which you've talked about increasingly you've got adjunctive therapy and also a monotherapy here so pretty versatile but.
Causes incredible disease stability and recovery. So we do see a lot of distinction versus let's say the competitors and we dealt with the competitors around the world. It's relatively new in the U S. So in terms of what we see on the on the market perspective.
Also bearing in mind that with oral therapies.
Highly genericize. So how are you thinking about.
Sales potential there and ultimately where you see your role in practice for tobacco done. Thank you.
Yes. Thanks for the question I'll start off and then turn it over to ruble.
The in play capture right now is roughly 80, 85% in favor of I Love.
So as Robin I mentioned, we're very very pleased with via <unk> around the around the world with sales ramping very very nicely and you know it is levodopa carbon dump. It. So it's the gold standard is just the ability to get that in the sub Q version.
And that's because of the 24 hour coverage you have far less supplemental oracles the levels of control there great, particularly when you wake up and you're in your through the night.
Other metric that we look at is in some cases, we've launched by 11 after sub Q April morphine has been available in the international countries and essentially the shares invert very very rapidly. So we're quite confident in our in the both short and long term position for a product like by 11.
Causes incredible disease stability and recovery. So we do see a lot of distinction versus let's say the competitors and we dealt with the competitors around the world. It's relatively new in the U S. So in terms of what we see on the on the market perspective the.
The in play capture right now is roughly 80, 85% in favor of ILS.
He is an exceptional.
Medication, so I'll turn it over Rupel to talk about the tobacco on development and then ultimately he and I can talk about where the positioning might be yeah. Thanks, Jeff Hi, It's Rupal, let me start on the on the violence briefly dovetailing on what Jeff just went through.
And that's because of the 24 hour coverage you have far less supplemental oracles the levels of control there great, particularly when you wake up and you're in your through the night. The other metric that we look at is in some cases, we've launched by 11 after sub Q April morphine has been available in the international countries and essentially the shares.
On the on the R&D side, we have received very favorable feedback thus far from caregivers and patients and I would say the word transformative is the common theme.
Invert very very rapidly so we're quite confident in.
And the benefit of via live as a full 24 hour.
In the both short and long term position for a product like buy all of it really is an exceptional.
Opportunity for state of control and that facilitates the ability to sleep and the ability to wake up on ready to go in face of the day. The competitor that you mentioned is a 16 hour profiles, who may not afford the same.
<unk>, so I'll turn it over Rupel to talk about the tobacco on development and then ultimately Eni can talk about where the positioning might be.
Yeah, Thanks, Jeff Hi, It's Rupal, let me start on the on the Viola briefly dovetailing on what Jeff just went through so on the on the R&D side. We have received very favorable feedback thus far from caregivers and patients and I would say the word transformative is the common theme and.
24 hour control.
Also as Jeff had mentioned viola delivers a meaningful dose of lethal Kirby deal, but so what that means is patients many patients no longer require their oral therapies. So that means a monotherapy simplified approach as possible. The competitor is provided as an adjunct.
The benefit of via live as a full 24 hour.
Opportunity for state of control and that facilitates the ability to sleep and the ability to wake up on ready to go in face of the day. The competitor that you mentioned is a 16 hour profiles. So it may not afford that same.
So it.
Won't be able to get off of your oral therapies also with vial of when you look at the maintenance phase dyskinesia rates are very low and with the competitor you mentioned, they're roughly 15 up to 30%.
24 hour control also as Jeff had mentioned viola delivers a meaningful dose of lethal carnaby dopa. So what that means is patients many patients no longer require the oral therapy. So that means a monotherapy simplified approach is possible there.
The other benefit of via live from a competitive standpoint is we see less than a 5% rate of sedation.
And with the apomorphine, it's around 20%.
Competitor is provided as an adjunct.
And also <unk>, we have limited headaches and this is in the teens.
So you won't be able to get off of your oral therapies.
With April morphine also another benefit of <unk> is no warnings for orthostatic hypotension or falls.
Also with vial of when you look at the maintenance phase dyskinesia rates are very low and with the competitor you mentioned, they're roughly 15 up to 30%.
That can't be said about the competitor and also we have very low rates and.
No need for treatment for nausea, and with Apomorphine initiation, you need an antiemetic and often that's need to be taken three times a day. So as Jeff stated I think we're very well positioned from a competitive standpoint with violet for all the reasons I just mentioned and then.
The other benefit of via live from a competitive standpoint is we see less than a 5% rate of sedation and with the apomorphine, it's around 20%.
And also <unk>, we have limited headaches and this is in the teens.
I think it's very important that we mentioned.
With April morphine also another benefit of <unk> is no warnings for orthostatic hypotension or falls.
<unk>, we I spoke about just it's being submitted and this will be a very nice complement of <unk> as a monotherapy and as an adjunct it's a once a day profile and has a long half life and.
That can't be said about the competitor and also we have very low rates.
No need for treatment for nausea, and with Apomorphine initiation you need an antiemetic.
And it is going to allow patients to optimize their regimen before the need to moving to advanced therapies, and where our clinicians are excited about differentiation from existing oral generics is the efficacy, which approaches legal carvey dopa and the safety profile.
And that's needed to be taken three times a day. So as Jeff stated I think we're very well positioned from a competitive standpoint with violet for all the reasons I just mentioned and then I think it's very important that we mentioned.
That could be a key differentiator and that's what our experts are telling us about specifically impulse control disorders.
<unk>, we I spoke about just it's being submitted and this will be a very nice complement of <unk> as a monotherapy and as an adjunct it's a once a day profile and has a long half life and.
Just around 1%, we've seen others reaches high of 30 or 40%.
Immediate people fall asleep with this one sedation is less than 5% dyskinesia around 2% and peripheral edema, which can be quite a nuisance with the generic molecules and very difficult to treat even if you use.
And it's going to allow patients to optimize their regimen before the need to moving to advanced therapies, and where our clinicians are excited about differentiation from existing oral generics is the efficacy, which approaches legal carvey dopa and the safety profile.
Potent diabetics, we don't see that as a problem, a 1% or less with <unk>. So we think for efficacy safety Tolerability reasons. It has a chance to differentiate and again, a very nice complement to violence.
That could be a key differentiator and that's what our experts are telling us about specifically impulse control disorders.
Just around 1%, we've seen others reach as high as 30 or 40%.
Great. Thanks, David.
Immediate people fall asleep with this one sedation is less than 5% dyskinesia around 2% and peripheral edema, which can be quite a nuisance.
Operator next question please.
Our next question comes from Dave Risinger with layered parts or excuse me partners. Your line is open.
Yes, thanks very much.
With the generic molecules and very difficult to treat even if you use.
Two questions. The first is could.
Potent diabetics, we don't see that as a problem, a 1% or less with Covid epidemic. So we think for efficacy safety Tolerability reasons. It has a chance to differentiate and again, a very nice complement to viola.
Could you please discuss the outlook for accelerating growth as Humira is absolute dollar declines diminish in coming years, and then second.
Could you Roop will just comment on the top few.
Pipeline candidate Readouts that we should focus on over the next six months I'm, assuming Amazon is one of them but.
Great. Thanks, David.
Next question please.
Our next question comes from Dave Risinger, with Leerink parts or excuse me partners. Your line is open.
What are what are the biggest cards that are turning over in the next six months or so thanks so much.
Yes, thanks, very much so I have two questions. The first is.
Could you please discuss the outlook for accelerating growth as Hugh mirrors absolute dollar declines diminish in coming years, and then second.
David This is Scott I'll just.
Some thoughts on your question about accelerating growth so you're.
You're right Humira continues to erode step down this year with her guidance, it's going to step down just over in the U S. Just over $4 billion, certainly that that step down in absolute dollars what will diminish.
Could you Roop will just comment on the top few.
Our pipeline candidate Readouts that we should focus on over the next six months I'm, assuming Amazon is one of them but.
And it will diminish next year as well of course, given the math.
We will see you know certainly, though you know significant percentage erosion from this year to next year as well that'll continue to erode as a tail starts to form a 26. So when you look at the business I mean, the business has a number of strong driver you've seen the growth of the business today I think that one thing that we've spoken about.
What are what are the biggest cards that are turning over in the next six months or so thanks so much.
David This is Scott I'll, just some thoughts on your question about accelerating growth so.
Several times as our long term guidance for high single digit growth through the decade that will be you know from from the growth that we have this year, we've talked about that accelerating as we hit that and we still remain extremely confident in our ability to achieve that high single digit growth through the decade on the top line. The bottom line, we will continue to expand this year R E.
You're right Humira continues to erode step down this year with her guidance, it's going to step down just over in the U S. Just over $4 billion, certainly that that step down in absolute dollars will diminish.
And then it will diminish next year as well of course, given the math.
We will see you know certainly though significant percentage erosion from this year to next year as well that'll continue to erode as a tail starts to form a 26. So when you look at the business I mean, the business has a number of strong drivers you've seen the growth of the business today I think that one thing that we've spoken about.
P. S is roughly in line a little bit of ahead of the earnings growth, but we're going to have operating margin expansion driven by leverage and efficiencies in the SG&A line. So you will see earnings growth expand a little bit faster than the revenue growth through the decade with that long term guidance.
Several times as our long term guidance for high single digit growth through the decade that will be you know from from the growth that we have this year, we've talked about that accelerating as we hit that and we still remain extremely confident in our ability to achieve that high single digit growth through the decade on the top line. The bottom line, we will continue to expand this year R E.
And then it's Rupal I'll talk about some of the Readouts. We're excited about moving into 2026 in immunology. Our IBD platform will start rating out data next year. This is in combination with sky really looking at those combos versus monotherapy Skype.
P. S is roughly in line a little bit of ahead of the earnings growth, but we're going to have operating margin expansion driven by leverage inefficiencies in the SG&A line. So you will see earnings growth expand a little bit faster than the revenue growth through the decade with that long term guidance.
<unk> <unk> is one of those and the others are one alpha four beta 738, two so we'll start seeing that data next year also in combination with <unk> mab plus rather than rheumatoid arthritis that'll be something else to look for and then maybe turning to <unk>.
And Dave It's Rupal I'll talk about some of the Readouts. We're excited about moving into 2026 in immunology. Our IBD platform will start rating out data next year. This is in combination with sky really looking at those combos versus monotherapy Skype.
Apology for a moment for team at Bay.
I went through a variety of different positive readouts.
Also next year expect to read out in head and neck cancer.
And even ovarian cancer, which many of these patients have a high C met expression along with canter Mig in a variety of different combinations in multiple myeloma and then our nexgen coming after Ella here.
E. <unk> is one of those and the others are one alpha four beta 7382. So we'll start seeing that data next year also in combination of <unk>, plus rather than rheumatoid arthritis that'll be something else to look for and then maybe turning to <unk>.
Our bypass topic fr Alpha antibody 151 will start seeding readouts there in platinum resistant ovarian cancer.
<unk> for a moment for team Abbe.
I went through a variety of different positive readouts.
And then also next year, we're excited about our using our Bispecific technology that we spoke about in immunology, along with our linker warhead technology from oncology, putting those together we have a bi specific ADC that binds to <unk> and steep for prostate cancer.
Also next year expect to read out in head and neck cancer.
And even ovarian cancer, which many of these patients have a high C met expression along with canter Mig in a variety of different combinations in multiple myeloma and then our nexgen coming after early here.
And that's another one I would say to look forward to next year and then in neuroscience, we have a follow on to <unk> 93, two we will start seeing data in bipolar depression.
Our bypass topic fr Alpha antibody 151 will start seeding readouts there in platinum resistant ovarian cancer.
Probably moving into 'twenty seven looking for generalized anxiety disorder, and then we'll also be able to give an update on <unk>.
And then also next year, we're excited about our using our Bispecific technology that we spoke about in immunology, along with our linker and warhead technology from oncology, putting those together we have a bi specific ADC that binds to <unk> and steep for prostate cancer.
We're currently conducting a multi ascending dose trial to see if we can move the dose.
30 milligrams and that has already initiated and we'll be able to give an update on where the dose lands and once it does we can start moving into phase III programs, there and schizophrenia is an adjunct and potentially as a model therapy, along with psychosis associated.
And that's another one I would say to look forward next year and then in neuroscience, we have a follow on to <unk> 93, two we will start seeing data in bipolar depression.
Probably moving into 'twenty seven looking for generalized anxiety disorder, and then we'll also be able to give an update on <unk>.
With neuro degeneration, and then on the obesity front the phase one study will get data in the first half of next year from healthy volunteers looking at different starting doses and different titration schemes.
We're currently conducting a multi ascending dose trial to see if we can move to dose above 30 milligrams and that has already initiated and we'll be able to give an update on where the dose lands and once it does we can start moving into phase III programs, there and kits.
However, these patients will have a normal BMI and we've already seen.
Reasonable weight loss there at six weeks. So it will also have 12 week data. The other thing Dave I'll mention is we're starting a phase one b program.
So for any as an adjunct and potentially as a model therapy, along with psychosis associated with neuro degeneration, and then on the obesity front. The phase one study will get data in the first half of next year from healthy volunteers looking at different starting doses and.
Late this year maybe into January when we get everything.
Everything started but that will also look at our 295 amylin asset, but the difference will be different titration and in patients that have obesity and that data will also likely read out probably in Q4 of next year. So I would say a very a robust number of <unk>.
Current titration schemes.
However, these patients will have a normal BMI and we've already seen.
<unk> that we should keep our eyes on.
Reasonable weight loss there at six weeks. So we'll also have 12 week data. The other thing Dave I'll mention is we're starting a phase one b program.
Thanks, David Operator next question please.
Yes. The next question comes from Steve Scala with Cowen Your line is open.
Late this year maybe into January when we get everything.
Thank you two questions Rob it sounds like IRA discounts are deeper this year than last year, you said it will not impact the long term outlook, but will it impact the impact the outlook in 2026 would.
Everything started but that will also look at our 295 amylin asset, but the difference will be different titration and in patients that have obesity and that data will also likely read out probably in Q4 of next year. So I would say a very robust number of <unk>.
Would you have yet to share externally, but will it impact the numbers that you otherwise would have shared externally.
<unk> why was revoked phase III NHS updated to complete in 2028 from 2026 previously was it an issue with endpoint enrollment or something else. Thank you.
<unk> said, we should keep our eyes on.
Thanks, David Operator next question please.
Our next question comes from Steve Scala with PD Cowen Your line is open.
Thank you two questions Rob it sounds like IRA discounts are deeper this year than last year, you said it will not impact the long term outlook, but will it impact the impact the outlook in 2026 would.
So Steve this is Rob I'll take your first question and then Roop will take your second question. So as it relates to the railcar and Linzess negotiations keep in mind those prices would not take effect until 2027.
Again as I mentioned before.
Would you have yet to share externally, but will impact the numbers that you otherwise would have shared externally.
We have visibility to where it's landing is obviously not public yet, but we're not concerned about it impacting our long term guidance, but theres no impact in 'twenty six because those prices are not take effect in 2006.
<unk> why was revoked phase III NHS updated to complete in 2028 from 2026 previously was it an issue with endpoint enrollment or something else. Thank you.
And Steve its ruble, we still anticipate our double blinded week 16 data at the end of next year in Hs.
So Steve this is Rob I'll take your first question and then Roop will take your second question. So as it relates to the railcar and Linzess negotiations keep in mind those prices would not take effect until 2027.
We will get other double blinded cuts and then Theres open label extension, so sometimes that.
Changes on duration.
We followed patients could result in some updates at <unk> Dot Gov.
Again as I mentioned before.
Thanks, Steve Operator next question please.
We have visibility to where it's landing is obviously not public yet, but we're not.
First question comes from Simon Baker with Roswell in Redburn. Your line is open.
Turn out as impacting our long term guidance, but there's no impact in 'twenty six because those prices are not take effect in 'twenty six.
Thank you for taking my questions. Two from me. Please firstly on Lindbergh can non segmental vitiligo.
And Steve its ruble, we still anticipate our double blind to the week 16 data at the end of next year and Hs.
In some markets that's up to 2% of the population. So I'm just wondering if you could give us some idea on your thoughts of the size of that opportunity.
We will get other double blinded cuts and then Theres open label extension, so sometimes that.
And then secondly on <unk>.
Mentioned in the press release that you own and launching in the UK at a mispriced equal to the U S. Now on the basis that people in the U S. Generally pay the list price should one assume the same situation in the U K and going forward in the UK and Europe do you envisage moving more to a U S style gross to net mark.
Changes on duration.
We followed patients could result in some updates at <unk> Dot Gov.
Thanks, Steve Operator next question please.
First question comes from Simon Baker, with Ross and Redburn. Your line is open.
Thank you for taking my questions. Two for me. Please firstly on Lindbergh can non segment video lie.
From the more net market that we see it in my thanks, so much.
In some markets has up to 2% of the population. So I just wonder if you could give us some idea on your thoughts of the size of that opportunity.
Yeah, So hi, it's Jeff I mentioned that as we look at the what we call. The next wave of innovation around <unk> and we've seen some of those readouts, which are really really encouraging.
Secondly on <unk>.
I noticed in the press release that you own.
In the UK.
<unk>, which is the smallest of the next set of indications as is performing really well and overall helping.
This price equal to the U S. Now on the basis that people in the U S. Generally pay the list price should one assume the same situation in the U K and going forward in the U K in.
Great momentum in Rheumatology. So then when we look at basically the let's say the next big four Okay. So you have alopecia areata.
Do you envisage moving moved to a U S style gross to net market from the more net market that we see at the moment. Thanks, so much.
Bill I go as you highlighted.
As Steve highlighted and then Lucas we've.
Yeah.
Look in size those that that that revenue potential is at least $2 billion at peak.
Yeah, So hi, it's Jeff I mentioned that as we look at the what we call. The next wave of innovation around rent book and we've seen some of those readouts, which are really really encouraging G.
So we continue to work through given as we look at the data we watch the market develop like how they will sort of adapt and change over time I can say that the alopecia data was quite striking I mean, it's quite striking relative to the standard of care.
<unk>, which is the smallest of the next set of indications as is performing really well and overall helping.
Great momentum in Rheumatology. So then when we look at basically the let's say the next big four Okay. So you have alopecia areata.
Other jacks that are out there so we're going through the sizing issue, we certainly see that there are.
Bill I go as you highlighted.
Different segments of it'll I go like a high body surface area is more amenable to let's say a JAK inhibitor like <unk>, which will be the first systemic is it active or is it stable.
As Steve highlighted and then lupus.
Looked in size those that that that revenue potential is at least $2 billion at peak.
So net net I mean, you could you could say that all of these together would be greater than $2 billion and we're going to continue to hone those forecasts as we as we go towards launches over the next year or so.
So we continue to work through given as we look at the data we watch the market develop like how they will sort of adapt and change over time I can say that the alopecia data was quite striking I mean, it's quite striking relative to the standard of care.
Other jacks that are out there so we're going through the sizing issue, we certainly see that there are.
Thanks, Simon Oh, Oh, sorry, one more one more question on <unk>, you're right the price in the U K. The list price is similar to the U S. One of the aspects that we are are.
Different segments of <unk> like a high body surface area is more amenable to let's say a JAK inhibitor like <unk>, which will be the first systemic is it active or is it stable.
We're looking at is how basically because of the most favored nation and other global pricing dynamics, how that may or may not change our approaches around the world certainly we would like to see reforms in many of the European countries, whether they are a clawback systems or even the way that the H D as well.
So net net I mean, you could you could say that all of these together would be greater than $2 billion and we're going to continue to hone those forecast as we as we go towards launches over the next year or so.
Because we do think that these medicine should be more highly valued so exactly how that will ultimately play out certainly some of the early.
Thanks, Simon Oh, I'm, sorry, one more one more question on <unk>, you're right the price in the U K. The list price is similar to the U S. One of the aspects that we are are.
The early discussions with the administration are around basically more stable and equitable pricing around G. Seven inclusive of Switzerland in Denmark. So all of that strategies are basically in place ultimately how that will play out.
Looking at is how basically because of the most favored nation and other global pricing dynamics, how that may or may not change our approaches around the world certainly we would like to see reforms in many of the European countries, whether they are a clawback systems or even the way that the H D as well.
We're going to continue to see certainly in the U K as you know you can have list prices, but ultimately it's an HDA market and we'll have to go through the nice evaluation to see where that net price ultimately would land.
Because we do think that these medicine should be more highly valued so exactly how that will ultimately play out certainly some of the early the early.
Thanks, Simon Operator next question please.
If our next question comes from Luisa Hector with Bahrenburg. Your line is open.
Discussions with the administration are around basically more stable and equitable pricing around <unk> seven inclusive of Switzerland in Denmark. So all of that strategies are basically in place ultimately how that will play out.
Thank you.
I'll kick off and then I'll, let Jean.
Just if you could outline your thoughts thank you.
T O.
Popcorn.
And then just sort of longer term question.
We're going to continue to see certainly in the U K as you know you can have list prices, but ultimately it's an HCA market and we will have to go through the nice evaluation to see where that net price ultimately would land.
Of market penetration do you think ultimately.
<unk> for the advanced therapy and enrollment here.
Sorry in the moment.
Indications.
Thanks, Simon Operator next question please.
Could we actually get to and would that require.
Our next question comes from Luisa Hector with bearing Byrne Your line is open.
The combination efficacy seen angle.
Platform technologies. Thank you.
Thank you.
Thank you.
And then I'll, let <unk>.
Hi, Luiz that's a ripple I'll start with the <unk>.
If you could outline your luck thank you kaki.
Insight to car T from cap Stan.
<unk> platform.
Platform.
What maybe some benefits and then we can talk about our plans.
And then just a longer term question.
Our market penetration do you think ultimately achievable for the advanced therapy.
We have an opportunity to optimize that dose.
Also an off the shelf therapy, we also see rapid expression and also transient expression. So over time that could have some safety advantages, especially if you can deplete the pathogenic T cells and then the naive b cell population.
The enrollment here.
And the moment sure.
Patients.
Could we actually get to and would that require.
The question the combination to me efficacy seen angle.
I mean platform technologies. Thank you.
Hi, Luiz that's a ripple I'll start with the <unk>.
Populate and you don't have the car onboard any longer and thats the advantage of the mrna.
Site to car T from cap stand what maybe some benefits and then we can talk about our plans.
Therapy in the early phase one we have observed b cell depletion and the other benefit is no need for lymphoid depletion.
We have an opportunity to optimize that dose. It's also an off the shelf therapy.
Together.
This could be a very exciting opportunity for patients. So next step is to continue.
We also see rapid expression.
And also transient expression so over time that could have some safety advantages, especially if you can deplete the pathogenic T cells and then the naive b cell population.
Dosing in the first in human studies, and then I would say next year. Once we have a handle on dosing, we'll start looking at patients starting on the rheumatology side of things like <unk> and lupus.
Populate and you don't have the car onboard any longer and that's the advantage of the mrna.
And if it works similar to ex vivo car T. We think patients can have very deep and durable.
Therapy in the early phase one we have observed b cell depletion and the other benefit is no need for lymphoid depletion so taken together.
Remissions, which could be very very important and certainly raises the bar and breaks through existing efficacy ceilings. So that's a I would say on.
This could be a very exciting opportunity for patients. So next steps is to continue.
Dosing in the first in human studies, and then I would say next year. Once we have a handle on dosing, we'll start looking at patients starting on the.
On cap stand on.
The oral side the nimble acquisition.
These.
Our macrocyclic molecules the ones that we were focusing on the attempt there is to make them as potent as possible and to extend the half life I think the current issue we see with certain oral platforms is that the half life is very limited, we think a benefit would be to extend that.
Rheumatology side of things like our E.
In lupus.
And if it works similar to ex vivo car T.
We think patients can have very deep and durable remissions, which could be very very important and certainly raises the bar and breaks through existing efficacy ceilings. So that's a I would say on <unk>.
Halfway so those are the two things are going on the lead candidates right now are in oral IL 23.
And a T L. One eight and when it comes to our IBD platform.
<unk> on the oral side the nimble acquisition.
With the combination the higher the efficacy the better.
These.
Our macrocyclic molecules the ones that we were focusing on the attempt there is to make them as potent as possible and to extend the half life I think the current issue we see with certain oral platforms is that the half life is very limited, we think a benefit would be to extend.
Obviously, but many of these patients that we'll see will be second line and potentially even in third line because lines of treatment are continuing to expand but many patients that have already received anti TNF in IBD and you see medicines like Sky Rizzi also starting to penetrate into that.
That half life. So those are the two things that are going on.
Frontline and if that's not working then you have JAK inhibitors like RIN Vogue, so we'd be studying a relatively refractory population. So if you can get 10 plus points better.
Lead candidates right now are in oral IL, 23, and <unk> and when it comes to our IBD platform.
With the combination the higher the efficacy the better obviously, but many of these patients that we will see will be second line and potentially even in third line because lines of treatment are continuing to expand because many patients that have already received anti TNF and IBD and you see.
The higher the better I think that would be a huge benefit because breaking through.
Current efficacy stands today has really been the challenge and I would say some of the best assets. We have are currently Renova Santa Rosa.
And then then the idea of the the market structure that you highlighted in your second question to.
<unk> medicines like Sky Rizzi also starting to penetrate into that frontline and if that's not working then you have JAK inhibitors like RIN book, So we would be.
<unk> point I mean, these immunology markets are quite amazing because you essentially have a bio penetration which varies by major indication and then you also have line of therapy expansion. So they are very very buoyant, because there's significant headroom and unmet need.
Steadying, a relatively refractory population.
If you can get 10 plus points better are the higher the better I think that would be a huge benefit because breaking through.
The book and when you look at bio penetration I'm going to give you the U S bio penetration rates roughly.
Current efficacy stands today has really been the challenge and I would say some of the best assets. We have are currently Renova Santa Rosa.
And the European and Asia are lower generally based on the way that those markets are developing the highest pennants bio penetration rates are in crohn's disease, which is above 50%. So you still have.
And then then the idea of the market structure that you highlighted in your second question to.
<unk> point I mean, these immunology markets are quite amazing because you essentially have a bio penetration which varies by major indication and then you also have line of therapy expansion. So they are very very buoyant, because there's significant headroom and unmet need.
Got a few patients in a very severe disease that have not been exposed to a biologic.
And these are in the moderate to severe segmentation.
On the very low end you have a super dynamic market, which is atopic dermatitis incredible high unmet need that just basically with the availability of drugs like do picks into and run book.
The book and when you look at bio penetration I'm going to give you the U S bio penetration rates roughly.
That may be in the high single digit bio penetration for moderate to severe so.
And the European and Asia are lower generally based on the way, though those markets are developing the highest pennant bio penetration rates are in crohn's disease, which as you know above 50%. So you still have.
New technologies are going to help communications are gonna help line of therapy is going to help that and that's why to rubles points. We're very excited about certainly the baseline adoption.
Adoption of these technologies, but transformative future technologies as well.
A few patients in a very severe disease that have not been exposed to a biologic.
And these are in the moderate to severe segmentation.
Thanks, Luisa operator next question please.
On the very low end you have a super dynamic market, which is atopic dermatitis incredible high unmet need that just basically with the availability of drugs like <unk> and <unk>.
So the next question comes from Mohit Bansal with Wells Fargo. Your line is open.
Great. Thank you very much for taking my question.
A couple of them. So one is an orally <unk> competitiveness months, who who but you mentioned some some limitations. There can you talk a little bit about how you think about this competition over time.
That may be in the high single digit bio penetration for moderate to severe so.
New technologies are going to help communications are going to help a line of therapy is going to help that and that's why to rubles points. We're very excited about certainly the baseline adoption.
Once he is a kind of if you will.
And then a portfolio question. So you do have aniline in.
Adoption of these technologies, but transformative future technologies as well.
This pace now with <unk>, how much do you think a portfolio of these assets.
Thanks, Luisa operator next question please.
So the next question comes from Mohit Bansal with Wells Fargo. Your line is open.
P or other assets is important due to fight and win in this particular segment given that detect the competition from incumbents have a portfolio of multiple assets out there. Thank you.
Great. Thank you very much for taking my question.
I have a couple of them. So one is an orally <unk> competitiveness months, who who but you mentioned some some limitations. There can you talk a little bit about how you think about this competition over time.
Thanks, Mohit ruble, so I'll start.
I think when we look at the Sky Rizzi first of all the psoriasis data are very strong.
Once he is a walk.
Uh huh.
And then a portfolio question. So you do have aniline in.
To think about some of the numbers that we have by week 16.
This pace now the group now.
Looking at clear or almost clear you're approaching 90% if youre looking at week 52, passing 90.
How much do you think a portfolio of these assets.
P or other assets is important due to fight and win in this particular segment given that detect the competition from incumbents have a portfolio of multiple assets out there. Thank you.
At 80% and if you had passed the 100 that's at 60%. So these are very very high efficacy.
And you also see over time, if you are an early passey respond or the majority of these folks are going to maintain.
Thanks, Mohit ruble, so I'll start.
I think when we look at the Sky Rizzi first of all the psoriasis data are very strong just to think about some of the numbers that we have by week 16, if youre looking at clear or almost clear youre approaching 90% if youre looking at week 52, passing 90.
Over the course of the year and beyond and even if there is treatment withdrawal and that's.
One thing I was getting at with the why do we like nimble a potential half life extension is that if you take oral some people may Miss some doses and if you have a very short half life.
That's at 80% and if you had passed the 100 that's at 60%. So these are very very high efficacy.
Treatment withdrawal data will sink very quickly.
And if you Miss many doses, you'll lose effect and with with Sky Rizzi and actually this is even in our label if you stop dosing for.
And you also see over time, if you are an early passey responder. The majority of these folks are going to maintain.
For one year, you still have 60% of patients that are clear or almost clear now if you keep dosing, obviously, you'll get to that 80% to 90% range. So I think it's important just to set up where is sky rizzi today and you have this opportunity to have quarterly dosing so the.
Over the course of the year and beyond and even if there is treatment withdrawal.
That's.
One thing I was getting at with the why do we like nimble a potential half life extension.
Is that if you take oral some people may Miss some doses and if you have a very short half life. Your treatment withdrawal data, we'll think very quickly and if you Miss many doses, you'll lose effect and.
<unk> have a chance to forget that they have psoriasis and they don't have to worry about when they eat their meals or how long they need to be fasting.
With with Sky Rizzi and actually this is even in our label if you stop dosing.
The other benefit is sky Ritchie has what I would like to say is head to toe benefits and these are all statistically significant readouts, what do I mean by that that means Palmer plant or that means scalp in general across the board.
For one year, you still have 60% of patients that are clear or almost clear now if you keep dosing, obviously, you'll get to that 80% to 90% range. So I think it's important just to set up where is <unk> today and you have this opportunity to have quarterly dosing so the.
Other insight.
Insight about psoriasis is about 30% or so we will have psoriatic arthritis, so they'll have joint disease and now with Sky. Originally we have five years of data.
<unk> have a chance to forget that they have psoriasis and they don't have to worry about when they eat their meals or how long they need to be fasting.
They're 88 approaching 90% of patients do not have X-ray progression.
The other benefit is sky Ritchie has what I would like to say is head to toe benefits and these are all statistically significant readouts, what do I mean by that that means Palmer plant or that means scalp in general across the board.
And I would say taking in totality that gives you gives us a benefit to continue to be very competitive whether you're talking about another injectable or even an oral and the oral as Jeff stated, we'll we'll have uptake like many of these assets.
The other insight.
Insight about psoriasis is about 30% or so we will have psoriatic arthritis, so they'll have joint disease and now with Sky. Originally we have five years of data.
Psoriasis. Unlike IBD is still quite underpenetrated, and it's a growing market.
They're 88 approaching 90% of patients do not have X-ray progression.
And maybe Jeff if you want to make a comment as well no I think it's I think it's very clear route below we're very confident in our competitive position and we've seen other oral has entered the market. We have multiple head to head trials in terms of where those oral <unk> will compete in what the differences are and so I think ruble phrased it very very nicely.
And I would say taking in totality that gives you gives us a benefit to continue to be very competitive whether you're talking about another injectable or even an oral and the oral as Jeff stated, we'll we'll have uptake like many of these assets.
This summary, and then on the Amylin, Yes, we think it would be of a benefit and we do continue.
Psoriasis. Unlike IBD is still quite underpenetrated, and it's a growing market.
To look.
Uh huh.
Partnered programs and external opportunities, where you could potentially combined with the amylin.
And maybe Jeff if you want to make a comment as well no I think it's I think it's very clear route below we're very confident in our competitive position and we've seen other orally enter the market. We have multiple head to head trials in terms of where those oral <unk> will compete in what the differences are and so I think ruble phrased it very very nicely.
And the focus there is.
Tolerability and durability, we continue to see.
Only about 30% of patients with obesity continuing their incretin. After one year. So these these beneficial games.
A summary, and then on the Amylin, Yes, we think it would be of a benefit and we do continue.
I'm not going to result in long term.
Favorable outcomes if patients can't stay on these so our focus is on the Amazon, but we continue to look for combination agents.
To look.
With.
Partnered programs.
And external opportunities, where you could potentially combined with the amylin and the focus there is.
Also other orthogonal approaches if you have the opportunity to maintain bone and muscle.
Tolerability.
And durability, we continue to see only.
And our next question comes from Geoff Meacham with Citibank. Your line is open.
Only about 30% of patients with obesity continuing there.
Okay.
So I just had two quick ones Rob on the policy side I know, we have some public agreements with the administration from your peers on Medicaid and Onshoring of manufacturing was curious if you expect to also have <unk>.
They are in creating this after one year. So these these beneficial games.
<unk> are not going to result in long term.
Favorable outcomes if patients can't stay on these so our focus is.
Is on the amylin, but we continue to look for combination agents.
Formal agreement if that's a priority for you guys the.
Also other orthogonal approaches if you have the opportunity to maintain bone and muscle.
The second thing on aesthetics. It still seems that we're seeing more macro headwinds and I know you've made some commercial and DTC investments and also has some new launches, but what would you say of the leading indicators of a rebound in aesthetics. So I'm just trying to assess what green shoots perhaps you may be saying thank you.
And then we're also exploring the potential.
Hi, Jeff it's Rob Thanks for the questions. So obviously, we continue to actively engage with the administration on ways to improve patient access and affordability and preserve U S leadership in medical innovation, we were having discussions before the July 31st letter and have had more discussion since.
We are aligned on the need to address global Freeloading and have been working closely with the U S. T. R on ways to address that which ultimately I think our section 301 investigation and unfair practices will be important as we partner with the administration.
To make progress in terms of pricing outside the U S. We're open to expanding direct to patient models, where it makes sense beyond what we already have in place with our Synthroid direct program. You've also seen us take actions to invest further in the U S by building a new API plant in our Chicago and expanding biologics capacity Westar as part of our 10 billion.
Capital commitment so you see the company's commitment to innovation.
<unk> future growth and that's certainly something we're in discussions with the administration about we also as we mentioned previously announced that <unk> has the price in the U K at the same list price as the U S. I'd say all of these actions are directionally aligned with the administration's stated goals and will continue to work with the administration on solutions that improve act.
And affordability, while also supporting future innovation.
I'll certainly share more information as we have it.
And Jeff some of the some.
Some of the dynamics that we're looking at that we monitor to your point I mean, these market conditions have been more protracted than we anticipated. So it is challenging to predict but here are a few of the things. We look at obviously, we're looking at sort of overall consumer confident confidence is quite low so that can be a leading indicator we.
You bet.
Oh.
Yeah.
No that our middle income consumers, particularly for Botox and toxins are also on the sidelines. So we monitor sort of their posture relative to sort of thinking.
Particularly new new treatment with a toxin, which is the leading indicator for the facial injectable business and we also as I highlighted in my remarks, we we're monitoring every month sort of the H a filler sentiment. So we've seen that stabilize to some degree which is good it's not continuing to go down but those are some metrics that we look at.
Early indicators to sort of anticipate sort of the market rebound and again, we're going to invest through that we think that that's a good idea certainly we also believe that trended bought the ability to activate new consumers, which will come next year for the U S market is as a significant catalyst to try to sort of lead this market back to.
Health.
Thanks, Jeff Operator, we'll take the next question please.
Okay.
Yeah.
Thank you and our next question comes from coronary, bringing with Bernstein. Your line is open.
Hi, all thanks, so much for taking our question today.
Okay you may continue.
Perhaps one more on the on the policy side and then just a follow up on the dock.
And our next question comes from Geoff Meacham with Citibank. Your line is open.
If you were to simply look at add these ratio of the business right now about 75% U S exposure versus 25% ex U S. How different do you expect that to be in five years' time, how much of that might be down to product mix and how much of that might be down to kind of equalizing.
Great can you guys hear me.
I will just cut off.
I'll just go.
Thanks, so much for the question.
Rob on the policy side I know, we have some public agreements with the administration from your peers on things like Medicaid and.
So some of these new U S policies and then the follow up in Renova, Chris just about the expansion opportunity associated with the changes to the Rainbow label can you just help us quantify that a little bit more cleanly.
Onshoring of manufacturing just was curious if you expect to also have a formal agreement if thats.
If that is a priority.
And then the SEC.
Yeah.
Thing on aesthetics, it still seems that we're seeing some more macro headwinds I know you've made some commercial.
So this is Rob I'll take your first question so you're right when you look at the business today.
And DTC investments as well as new launches, but what would you say are the leading indicators of a of a rebound I'm just trying to assess what kind of green shoots you may be seeing thank you.
It's in the 75% U S, 25% International I think historically before Humira you saw it more like two thirds one third we haven't publicly disclosed what that U S. O U S. Ex mix will look like over the long term obviously its portfolio dependent I would say that is the larger driver flux.
Thanks, Mitchell with asking a question.
Can't hear anything.
Fluctuations that you see there versus.
Jeff The minor you can go onto your question again, sorry go ahead with your question.
Assumptions around price.
And so as we drive this business given the innovative platform theres opportunities to grow in the U S is a great opportunity to grow internationally.
Can you guys hear me at all.
Now we can hear you hi, Jeff.
Okay, Alright, yes. Unfortunately.
The way to think about it is if you think about his historical levels, where it was before humira.
Yes.
Okay.
So I just had two quick ones Rob on the policy side I know, we have some public agreements with the administration from your peers on Medicaid and Onshoring of manufacturing was curious if you expect to also have.
Not a bad way to think about where it could go over time.
But we haven't publicly disclosed what that mix looks like in our long term outlook.
And then in terms of the enhanced our IBD label now, we we haven't fully quantified it but I would say, it's clearly a net incremental positive.
A formal agreement if thats a priority for you guys.
The second thing on aesthetics. It still seems that we're seeing more macro headwinds and I know you've made some commercial and DTC investments and also has some new launches, but what would you say are the leading indicators of a rebound in aesthetics I'm just trying to assess what green shoots perhaps you may be saying thank you.
We werent sure frankly that.
We would get this type of language as we worked with the U S Kols and the FDA, but we did so we're very happy with that clearly what we see is that this benefit.
We will build over time based on the dynamics that I mentioned in ruble mentioned, which is youre seeing a very significant transformation over the structure of the IBD space, whereas a.
Hi, Jeff it's Rob Thanks for the questions. So obviously, we continue to actively engage with the administration on ways to improve patient access and affordability and preserve U S leadership in medical innovations, we were having discussions before the July 31st letter and have had more discussion since I would say we are aligned on the need to address global Freeload.
A few years ago was a heavy TNF focus and now you see this ascension of the IL 20, threes, you certainly still have entyvio in there and so this is this is a this is a net positive and we're going to continue to monitor how effective this is with that that one two punch with that in place share that were continued to be very <unk>.
<unk> and have been working closely with the U S. T. R on ways to address that which ultimately I think our section 301 investigation and unfair practices will be important as we partner with the administration.
With.
Thanks, Courtney operator, we have time for one final question.
To make progress in terms of pricing outside the U S. We're open to expanding direct to patient models, where it makes sense beyond what we already have in place with our Synthroid direct program. You've also seen us take actions to invest further in the U S by building a new API plant in our Chicago and expanding biologics capacity Westar as part of our 10 billion.
Yes, our last question comes from Hassan here with Goldman Sachs. Your line is open.
Thanks for taking the question just maybe Rob for you on M&A and just any updated thoughts following the recent acquisition of Capstone Gilgamesh.
Curious as to what your latest thinking is on business development, you always referenced BD priorities that are geared towards the 2013 is that still the case and amongst your core therapeutic areas. What would you prioritize adding and then just also curious if you have any appetite for larger deals. Thank you.
Capital commitment do you see the company's commitment to innovation drives.
Driving future growth and that's certainly something we're in discussions with the administration about we also as we mentioned previously announced that <unk> has the price in the U K at the same list price as the U S. I'd say all of these actions are directionally aligned with the administration's stated goals and will continue to work with the administration on solutions that improve <unk>.
Thanks Hassan this is Rob I'll take that question Youre right. Our BD focus continues to be on assets that can drive growth in the next decade and beyond I mean, we certainly have the financial wherewithal to pursue late stage opportunities as well, but that's not really a need given that our current portfolio provides a clear line of sight to growth into the next decade, and that's why we have focus.
Access and affordability, while also supporting future innovation, and we'll certainly share more information as we have it.
And Jeff some of the.
Our efforts on novel mechanisms and platform technologies that can drive longer term growth and that includes b cell depletion approaches, which rubel mentioned and oral peptides capabilities in immunology, the tri specifics and and in in vivo car T platform in oncology.
Some of the dynamics that we're looking at that we monitor to your point I mean, these market conditions have been more protracted than we anticipated. So it's challenging to predict but here are a few of the things. We look at obviously, we're looking at sort of overall consumer confidence confidence. It is quite low so that that can be a leading indicator we.
You look at neuroscience as novel mechanisms for mood disorders in Alzheimers that we've licensed then.
No that our middle income consumers, particularly for Botox and toxins are also on the sideline. So we monitor sort of their posture relative to sort of seeking.
And we have a very compelling SA RNA platform that can generate opportunities across all three of those therapeutic areas and will also utilize BD to enter another growth area obesity, which as Paul mentioned, we will build upon again given the strong outlook of the portfolio will continue to focus on BD efforts.
Particularly new new treatment with a toxin, which is the leading indicator for the facial injectable business and we also as I highlighted in my remarks, we we're monitoring every months sort of the H a filler sentiment. So we've seen that stabilize to some degree which is good. It's just not continuing to go down but those are some metrics that we look at.
That really drive long term pipeline opportunities and areas of focus are our core areas immunology and neuroscience oncology aesthetics, and we've now added obesity.
For early indicators to sort of anticipate sort of the market rebound and again, we're going to invest through that we think that that's a good idea certainly we also believe that trended bought the ability to activate new consumers, which will come next year for the U S market is as a significant catalyst to try to sort of lead this market back.
And so when you think about those are the areas. If you look about the 30 deals we've executed more than 30 deals are executed over the last 18 plus months theres been a nice mix between immunology oncology neuroscience and a few deals in aesthetics.
You should expect us to continue to add I'd say very robust depth to our pipeline to drive that long term growth well into the next decade.
Health.
Thanks, Jeff Operator, we'll take the next question please.
Thank you. Our next question comes from Courtney <unk> with Bernstein. Your line is open.
Thanks for that and that concludes today's conference call, if you'd like to listen to a replay of the call. Please visit our website at investors Dot Dot com. Thanks again for joining us.
Hi, all thanks, so much for taking our question today.
Perhaps one more on the on the policy side and then just a follow up on Limbach.
Thank you and that concludes today's conference you may all disconnect at this time.
If you were to simply look at these ratio of the business right now about 75% U S exposure versus 25% ex U S. How different do you expect that to be in five years' time, how much of that might be down to product mix and how much of that might be down to a kind of equalize.
And price on some of these new U S policies and then the follow up on Renova, Chris just about the expansion opportunity associated with the changes to the Rainbow label can you just help us quantify that a little bit more cleanly. Thank you.
So this is Rob I'll take your first question so you're right when you look at the business today.
It's in the 75% U S, 25% International I think historically before Humira you saw it more like two thirds one third we haven't publicly disclosed what that U S. O U S. Ex mix will look like over the long term.
Its portfolio dependent I would say that is the larger driver fluctuations.
Fluctuations that you see there versus.
Assumptions around price.
And so as we drive this business given the innovative platform there is opportunities to grow in the U S is a great opportunity to grow internationally.
But the way to think about it is if you think about his historical levels, where it was before humira.
That's not a bad way to think about where it could go over time.
But we haven't publicly disclosed what that mix looks like in our long term outlook.
And then in terms of the enhanced IBD label, we we haven't fully quantified it but I would say, it's clearly a net incremental positive we werent sure frankly that that.
We would get this type of language as we worked with the U S Kols and the FDA, but we did so we're very happy with that clearly what we see is that this benefit will build over time based on the dynamics that I mentioned in ruble mentioned, which is youre seeing a very significant transformation over the structure.
<unk> of the IBD space, whereas.
A few years ago was a heavy TNF focus and now you see this ascension of the IL 20, threes, you certainly still have entyvio in there and so this is this is this is a net positive and we're going to continue to monitor how effective this is with that that one two punch with that in play share that were continued to be very.
With <unk>.
Thanks, Courtney operator, we have time for one final question.
Yes, our last question comes from Hassan Hanger with Goldman Sachs. Your line is open.
Thanks for taking the question just maybe Rob for you on M&A and just any updated thoughts following the recent acquisitions capstone in Kokomo.
Curious as to what your latest thinking is on business development, you always referenced the BD priorities that are geared towards the 2000 Thirty's is that still the case and amongst your core therapeutic areas, where would you prioritize adding and then just also curious if you have any appetite for larger deals. Thank you.
Thanks Hassan this is Rob I'll take that question at you are right. Our BD focus continues to be on assets that can drive growth in the next decade and beyond I mean, we certainly have the financial wherewithal to pursue late stage opportunities as well, but that's not really a need given that our current portfolio provides a clear line of sight to growth into the next decade and Thats why we are focus.
Our efforts on novel mechanisms and platform technologies that can drive longer term growth and that includes b cell depletion approaches, which rubel mentioned and oral peptides capabilities and immunology, the tri specifics and and in in vivo car T platform in oncology.
You look at neuroscience as novel mechanisms for mood disorders in Alzheimers that we've licensed then.
And we have a very compelling SA RNA platform that can generate opportunities across all three of those therapeutic areas and also utilize BD to enter another growth area obesity, which as Paul mentioned, we will build upon again given the strong outlook of the portfolio will continue to focus on BD efforts.
That really drive long term pipeline opportunities and areas of focus are our core areas of immunology and neuroscience oncology statics and we've now added obesity.
And so when you think about it those are the areas. If you look about the 30 deals we've executed more than 30 deals are executed over the last 18 plus months theres been a nice mix between immunology oncology and neuroscience a few deals in aesthetics. So I think you should expect us to continue to add I'd say very robust depth to our pipeline to drive that long term growth.
<unk> well into the next decade.
Thanks for that and that concludes today's conference call, if you'd like to listen to a replay of the call. Please visit our website at investors Dot Abbvie dot com. Thanks again for joining us.
Thank you and that concludes today's conference you may all disconnect at this time.