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DATE
Friday, Oct. 31, 2025 at 9 a.m. ET
CALL PARTICIPANTS
Chairman and Chief Executive Officer — Robert A. Michael
President and Chief Operating Officer — Jeffrey Ryan Stewart
Chief Medical Officer and Head of R&D — Roopal Thakkar
Executive Vice President, Chief Financial Officer — Scott T. Reents
Vice President, Investor Relations — Liz Shea
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RISKS
HUMIRA Global Sales — Declined 55.7% operationally to $993 million in Q3 2025, primarily due to biosimilar competition, with further access erosion in The U.S. expected into 2026.
Aesthetics Global Sales — Decreased 4.2% operationally to $1.2 billion in Q3 2025, with "challenging market conditions in several key markets" according to Jeffrey Ryan Stewart noted as softening consumer demand, especially in The U.S.
Botox Cosmetic and Juvederm — Both experienced operational sales declines, attributed to continued "market softness" according to Scott T. Reents and low consumer sentiment tied to economic uncertainty and inflation.
IMBRUVICA Sales — Continued to decline due to "competitive dynamics in CLL," partially offsetting growth from newer oncology products.
TAKEAWAYS
Adjusted EPS -- $1.86, $0.10 above the guidance midpoint, inclusive of $1.5 billion in unfavorable acquired IPR&D expense from the KapStan Therapeutics and IGI deals.
Total Net Revenues -- Nearly $15.8 billion in total net revenues, representing 8.4% operational growth and exceeding internal expectations by approximately $300 million.
Immunology Revenue -- $7.9 billion, up 11.2% operationally, driven largely by SKYRIZI and RINVOQ.
SKYRIZI Global Sales -- $4.7 billion, up 46% operationally, demonstrating strong share gains in IBD and psoriasis.
RINVOQ Global Revenues -- Nearly $2.2 billion, up 34.1% operationally, supported by label expansion in IBD and advanced uptake in rheumatology and dermatology.
Neuroscience Revenue -- More than $2.8 billion, up 19.6% operationally, with QLIPTA is now the leading CGRP treatment for migraine prevention, with a total prescription share of approximately 7.5%, robust migraine franchise growth, and Vraylar sales of $934 million, up 6.7%.
Violet (BIOLEV) Sales -- $138 million, up 40% sequentially, with current in-play capture is roughly 80-85% in favor of VioLev.
Oncology Revenue -- Nearly $1.7 billion, relatively flat compared to the prior year, as growth in VENCLEXTA and new products offset the IMBRUVICA decline.
Aesthetics Revenue -- $1.2 billion, down 4.2% operationally, with Botox Cosmetic at $637 million and Juvederm global sales were $253 million, both declining operationally.
Dividend Increase -- Quarterly cash dividend raised 5.5% to $1.73 per share, beginning with the February 2026 payout.
Raised 2025 Guidance -- Full-year 2025 adjusted EPS is expected to be between $10.61 and $10.65, and Net revenue guidance was raised to approximately $60.9 billion for the full year 2025, up $400 million from the prior outlook.
Pipeline Milestones -- Regulatory submissions and key data readouts expected in late 2025 and 2026 for tevapadon, PIVEC, tMAbA, and for several expanded and new indications across major franchises.
Acquisition Activity -- Closed acquisition of KapStan Therapeutics (in vivo CAR T platform) and Gilgamesh (bretasilosin; phase 2 NDD psychedelic), contributing to pipeline diversification.
Cash Flow and Capital -- More than $5.6 billion in cash on hand as of September 2025, $13 billion in free cash flow generated in the first nine months of 2025, including $2.2 billion from SKYRIZI royalties.
Manufacturing and R&D Investment -- Construction underway on new North Chicago API manufacturing site and Worcester biologics/R&D expansion, as part of a $10 billion U.S. investment over the next ten years.
SUMMARY
AbbVie (ABBV 4.45%) raised its full-year 2025 sales and adjusted earnings guidance for the third time this year, citing operational revenue and earnings outperformance across multiple growth platforms. SKYRIZI and RINVOQ together delivered sales growth of more than 40%. New label expansions and pending regulatory submissions in major segments were explicitly highlighted as upcoming catalysts for sustained future growth. Management cited both commercial and pipeline progress as supporting capital returns, including a 5.5% dividend increase (beginning with the dividend payable in February 2026) and significant investments in U.S. manufacturing capacity.
Robert A. Michael said, adjusted earnings per share of $1.86, which is $0.10 above our guidance midpoint.
The growth platform segments, excluding HUMIRA, delivered over 20% reported sales growth.
Neuroscience global revenues were revised upward by $200 million to $10.7 billion for 2025.
Adjusted gross margin reached 83.9% in Q3 2025, while and year-to-date free cash flow of approximately $13 billion for the first nine months of 2025 supported both dividend growth and business development activities.
Management confirmed guidance for high single-digit compound revenue growth from 2024 through 2029, noting 2025 sales outlook exceeds AbbVie's previous peak revenue by nearly $3 billion within two years of LOE events.
IMBRUVICA and HUMIRA headwinds were offset by mix shift toward next-generation immunology and neuroscience assets; full pharmaceutical leverage expected as LOE impacts moderate from 2026 onward.
The company has executed approximately 30 business development transactions since 2024, with continued priority on external assets targeting 2030s growth across immunology, neuroscience, oncology, aesthetics, and obesity.
INDUSTRY GLOSSARY
LOE (Loss of Exclusivity): The point at which a brand drug loses patent protection and faces generic or biosimilar competition.
IBD (Inflammatory Bowel Disease): Encompasses Crohn's disease and ulcerative colitis, major targets for biologic drugs like SKYRIZI and RINVOQ.
TNF (Tumor Necrosis Factor) Inhibitor: A class of drugs targeted by anti-TNF and referenced in treatment paradigms for IBD and rheumatology.
ADC (Antibody-Drug Conjugate): Biologic molecules designed to deliver cytotoxic agents directly to cancer cells.
tMAbA: AbbVie’s proprietary antibody-drug conjugate with pivotal data in multiple cancers.
IPR&D Expense: In-Process Research & Development costs associated with acquired intangible R&D assets.
API (Active Pharmaceutical Ingredient): The core component responsible for a drug’s therapeutic effect.
CGPR (Calcitonin Gene-Related Peptide) Treatment: Targeted migraine therapy category including oral and injectable agents.
Full Conference Call Transcript
Robert A. Michael: 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, 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. Starting with our third quarter performance, we delivered adjusted earnings per share of $1.86, which is $0.10 above our guidance midpoint. Total net revenues were nearly $15.8 billion, 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 SKYRIZI and RINVOQ, our leading immunology medicines, 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. 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. 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. 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 are making excellent progress and expect several important milestones over the next two years, including new product approvals for tevapadon and PIVEC, expanded indications for RINVOQ, Epkinley, Culipta, and Yubrelvi, and pivotal data for lutekizumab, dMAbA, and etentamig. 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 recent deal activity includes announcing the acquisition of Gilgamesh's Bredesilocin, expanding our psychiatry pipeline with a next-generation psychedelic currently in phase two development for NDD, and closing the acquisition of KapStan Therapeutics, further strengthening our immunology pipeline with an in vivo CAR T platform. 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. This includes investing at least $10 billion of capital in The US over the next ten 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. We are also committed to delivering a healthy, sustainable dividend that grows every year. Today, we announced a 5.5% increase in our quarterly cash dividend, beginning with the dividend payable in February 2026. 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?
Jeffrey Ryan Stewart: Thank you, Rob. Starting with the quarterly results for immunology, which delivered total revenues of approximately $7.9 billion, up 11.2% on an operational basis. SKYRIZI and RINVOQ continue to exceed our expectations, once again demonstrating robust growth across a broad set of indications. SKYRIZI global sales were $4.7 billion, reflecting operational growth of 46%. 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 medicines are on pace to nearly double their combined sales in IBD this year. Our uptake in Crohn's disease remains impressive, with SKYRIZI and RINVOQ together achieving in-play 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. We see similar momentum in ulcerative colitis as well, with SKYRIZI and RINVOQ collectively holding in-play share leadership in more than 10 key markets and capturing nearly one out of every three new or switching UC patients across all mechanisms in The U.S. 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, SKYRIZI with less frequent dosing favored by patients and clinicians, especially for the maintenance treatment relative to the most effective dose for other IL-23s, 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. 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 inadvisable. So we remain very competitively positioned for continued strong growth across gastroenterology.
Moving to the rest of our core immunology indications, SKYRIZI 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. 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. 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. 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 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. 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. 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. Moving to oncology, which delivered total revenues of nearly $1.7 billion, relatively flat versus the prior year.
Momentum from VENCLEXTA as well as newer products Elihir, Kinley, and Amrelis helped to offset the expected sales decline from IMBRUVICA, which continues to be impacted by competitive dynamics in CLL. 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. These efforts will 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 $1.2 billion, down 4.2% 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.
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 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. 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, 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 Trinobot 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'm very pleased with our leading migraine portfolio, with Ubrellvi, QLIPTA, and BOTOX Therapeutic all delivering robust double-digit growth.
QLIPTA is now the number one CGRP treatment for migraine prevention, with a total prescription share of approximately 7.5%. Vraylar is also performing well in both bipolar and AMDD, with total sales of $934 million, up 6.7%. Physicians continue to report positive feedback on Vraylar's 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, Violet's launch trajectory has been very impressive. Total 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 twenty-four-hour delivery and the control of symptoms throughout the morning, day, and night. BIOLEV is the only Parkinson's treatment that often replaces the need for add-on oral therapies to manage motor fluctuations, reducing the daily pill burden for these patients. We anticipate expanded coverage of BIOLEV in The U.S. soon, which we expect will provide further revenue inflection next year. I'm also excited about tevapadon, where we are pursuing approval for use as a monotherapy 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 Vylev and DUOPA. 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. Our commercial execution has been outstanding. And with that, I'll turn the call to Rupl for comments on our R&D highlights. Rupl?
Roopal Thakkar: Thank you, Jeff. Starting with immunology, we announced positive top-line results from the second Phase III RINVOQ alopecia areata trial, reinforcing the potential for RINVOQ 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 RINVOQ demonstrating meaningful improvement in hair regrowth across both doses compared to placebo. We remain on track to begin submitting regulatory applications later this year. We also recently announced positive top-line results from two phase three RINVOQ vitiligo trials. In both studies, RINVOQ met the co-primary and key secondary endpoints at week forty-eight, demonstrating improvements in both total body and facial vitiligo scoring compared to placebo.
We are very pleased with these results, which illustrate RINVOQ's potential to provide significant skin repigmentation to patients suffering from non-segmental vitiligo. The daily challenges of living with this condition can often lead to depression and anxiety. With no approved systemic treatment, there is very high unmet need for these patients. Once approved, RINVOQ 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 RINVOQ to HUMIRA in RA patients who had an inadequate response or intolerance to their first TNF inhibitor. This is the first head-to-head study comparing anti-TNF cycling versus switching to RINVOQ.
In the study, RINVOQ demonstrated superiority to HUMIRA for efficacy measures, with nearly twice as many patients achieving low disease activity and remission. For RA patients who did not respond well to their first TNF inhibitor, these results clearly show the benefit of switching to RINVOQ rather than cycling to another anti-TNF. In IBD, RINVOQ recently received a label update in Crohn's disease and ulcerative colitis, allowing its use prior to anti-TNFs in patients who have received at least one approved systemic therapy when TNF inhibitors are clinically inadvisable. The treatment paradigm has evolved in IBD, with increasing utilization of newer, higher efficacy agents like SKYRIZI.
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 RINVOQ prior to anti-TNFs for certain patients after they have tried another approved systemic therapy. Moving to oncology, the regulatory application was submitted to the FDA for PIVEC in blastic plasmacytoid dendritic cell neoplasm. This rare aggressive blood cancer primarily affects an older population who is at high risk for complications with traditional chemotherapy or 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.
At the recent ESMO meeting, we presented three orals for tMAT A, highlighting this novel ADC's potential both as a monotherapy and in combination across advanced difficult-to-treat solid tumors. In CRC patients who receive two or more prior lines of therapy, and regardless of c Met expression levels, tMAbA in combination with bevacizumab demonstrated manageable safety and better responses and disease control compared to current standard of care. Treatment with t mAbA at 2.4 milligrams per kilogram plus bevacizumab achieved an objective response rate of 30% and a confirmed disease control rate of 97%, compared to rates of 0% and 70% respectively for Loncerf plus Bevacizumab.
Based on these results, we plan to begin a phase three study for this combination in late-line all-comers CRC. In a proof-of-concept study in pancreatic cancer, monotherapy tmAbA demonstrated an objective response rate of 24% in the overall population and 40% in patients who received first-line gemcitabine plus Abraxane. A phase two study in pancreatic cancer is expected to begin next year. And in an exploratory study in metamplified solid tumors, after progression following standard of care, monotherapy with tMAb A resulted in an objective response rate of 47% and median duration of response of twelve and a half months for the 2.4 milligram 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 two study in metamplified solid tumors is expected to begin later this year. We are making significant progress with tmAbA 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 tMAbA programs as data mature. In neuroscience, the regulatory application for tevavadon 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.
Our selective D1D5 receptor partial agonist demonstrated robust efficacy as a monotherapy in early Parkinson's disease and as an adjunct to levocarbio dopa oral therapy in patients still experiencing motor fluctuations. Once approved, we believe tevapadon will be an important new treatment option. Results from a phase two study evaluating Botox in upper limb essential tremor were recently presented at the MDS. In the study, Botox met the primary and all secondary endpoints, demonstrating significant improvements 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.
Current treatment options are limited in terms of both efficacy and tolerability, leaving considerable need for new therapies. Based on these results, we plan to advance a new toxin for upper limb essential tremor. Gemiabat A is a novel toxin that has demonstrated different pharmacologic properties preclinically compared to Botox, such as less diffusion to neighboring muscles. Phase two studies for gemimibatte in essential tremor and ventral hernia repair will begin next year. To further expand our neuropsychiatry pipeline, we acquired bretasilosin from Gilgamesh. Gretasilocin is a novel five HT2A receptor agonist and five HT releaser, with a short duration of hallucination that has demonstrated robust efficacy in a phase two proof-of-concept study in major depressive disorder.
Rapid efficacy was achieved after the initial dose, with response and remission maintained through day seventy-four without additional intervention. This novel psychedelic has the potential to provide significant benefit to patients by offering rapid, robust, and durable antidepressant effects following a short in-clinic treatment session. Additional phase two studies in depression are expected to begin next year. 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. With that, I'll turn the call over to Scott.
Scott T. Reents: Thank you, Rupal. Starting with our third-quarter results, we reported adjusted earnings per share of $1.86, which is $0.10 above our guidance midpoint. These results include a $1.5 unfavorable impact on acquired IPR and D expense, primarily reflecting upfront charges for the acquisition of KapStan Therapeutics and our license agreement with IGI. Total net revenues were nearly $15.8 billion, reflecting growth of 8.4% on an operational basis, excluding a modestly favorable impact from foreign exchange. Importantly, our ex-HUMIRA growth platform delivered reported sales growth of more than 20%, once again exceeding our expectations. 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.
The adjusted operating margin ratio was 30.9% of sales, which includes a 17% unfavorable impact from acquired IPR and D expense. Net interest expense was $667 million. The adjusted tax rate was 24.5%, reflecting the lower deductibility of acquired IPR D expense this quarter. Turning to our financial outlook, we are raising our full-year adjusted earnings per share guidance to between $10.61 and $10.65. Please note that this guidance does not include an estimate acquired IPR and B expense that may be incurred beyond the third quarter. We now expect total net revenues of approximately $60.9 billion, an increase of $400 million.
This updated forecast primarily reflects SKYRIZI global sales of $17.3 billion, 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 GRAILAR, Botox Therapeutic, Vylev, and the total oral CGRP portfolio. Aesthetics total sales of $4.9 billion, a decrease of $200 million, reflecting greater than expected market softness globally. With the remaining $200 million increase, reflecting the collective momentum from RINVOQ and several other products across our diverse 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, adjusted R&D expense of $9 billion, and adjusted SG&A expense of $13.5 billion. 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 IPR and D expense incurred through the third quarter. And we now forecast our non-GAAP tax rate to be approximately 17.3%, also reflecting the impact of acquired IPR and D. Turning to the fourth quarter, we anticipate net revenues of more than $16.3 billion. This reflects an estimated 1% favorable impact from foreign exchange on sales growth.
We expect adjusted earnings per share between $3.32 and $3.36. This guidance does not include acquired IPR and D expense that may be incurred in the quarter. Finally, AbbVie's robust business performance continues to support our capital allocation priorities. Our cash balance at the September was more than $5.6 billion, and we generated approximately $13 billion of free cash flow in the first nine months of the year, which includes nearly $2.2 billion of SKYRIZI royalty payments. This free cash flow fully supports a strong and growing quarterly dividend, which we are increasing 5.5% to $1.73 per share, beginning with the dividend payable in February 2026, as well as capacity for continued business development.
We have executed approximately 30 deals since 2024, and we continue to assess external innovation across all of our key growth areas. We also remain on track to achieve a net leverage ratio of two times by 2026. In closing, AbbVie once again delivered outstanding results, and our financial outlook remains very strong. With that, I'll turn the call back over to Liz.
Liz Shea: Thanks, Scott. We will now open the call for questions. In the interest of hearing from as many analysts as possible over the remainder of the call, we ask that you please limit your questions to one or two. Cedric will take the first question, please.
Operator: Yes. And our first question comes from Terence Flynn with Morgan Stanley. Your line is open.
Terence Flynn: 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 of the new PBM model that Cigna 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 VRAYLAR and LINZESS. Thank you.
Robert A. Michael: Thanks, Terence. So this is Rob. I'll start with your first question. I'm going to have actually Jeff supplement as well. But I think one thing that's important to think about as it relates to whether it's PBM reform, questions we've got on DTC, also what drives AbbVie'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 utilizing the tools that are available to us. If there are changes to the PBM 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 as that is what delivers real value and can drive growth in any environment. And I'll let Jeff speak more specifically to how we see the PBM model playing out.
Jeffrey Ryan Stewart: Yeah, thanks, Rob, and just to sort of reiterate this approach, I mean, if you think about some of these announcements over the years, whether it's rebate pass-through or there's existing notes like this that work today. And we think there's a lot of merit to that, like the ability for patients to share in lowering their out-of-pocket costs at the counter is a good approach. There's been a lot of 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're using those rebates, maybe to lower premiums. We all know those stories.
I think the key point is Rob's point that you know, across, you know, my global footprint, we're used to dealing with any type of 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, or HTA markets. So we're very, very adaptable to 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 and a competitive perspective. So we'll continue. We don't know a lot of the details, but we talk to Cigna all the time. Our account teams talk.
We talk at the executive level. So we'll continue to study, but we're very confident in terms of if there were to be changes in the PBM model, we would adapt very well. And Terence, this is Rob again. On your question regarding IRA, the 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 Vraylar and LINZESS will not impact our long-term guidance.
Liz Shea: Thanks, Terence. Operator, next question please.
Operator: Yes. Our next question comes from Chris Schott with JPMorgan. Your line is open.
Christopher Thomas Schott: Great. Thanks so much. Just would love a little bit more of a discussion on the IL-23 market. Obviously, SKYRIZI doing really well here. But just with the TREMFYA subcu 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 and your nearest competitor kind of evolving over time? Then my second question is just any initial look on 2026 as 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.
Jeffrey Ryan Stewart: Yeah, hi Chris, it's Jeff. I'll take your first question. So yes, we are very pleased with SKYRIZI's growth overall and in the quarter. I mean 46% year over year is quite strong. So and we see that momentum. It's share gains. It's market growth. And we retain a very, very strong in-play share position in IBD. It's really a leadership position. What we do see is, you know, we know that Tremfya is going to gain some market share and in-play share, but what's actually happening is the category or the class of IL-23s 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, some more recent numbers to see how dramatic this is. So just over a year ago, when the IL-23s were entering, the NBRx share for UC, the is ulcerative colitis, which is the smaller of the two, was around five percent. That was the penetration rate. Now it's approaching, in this latest quarter, close to forty percent. So this is a dramatic change in the adoption of the IL-23s. SKYRIZI continues to grow. TREMFYA will grow. Yes, there are subtle differences, but we're super confident in where this product will go. So SKYRIZI is performing very, very well and will continue to do so.
And don't forget, it's just not SKYRIZI story. AbbVie has uniquely a sort of a one-two punch in this market. We got SKYRIZI and RINVOQ. And as I mentioned in my prepared remark, our position with RINVOQ just got significantly stronger for gastroenterologists and patients with that enhanced indication. So what that allows to do is that physicians, they choose, if someone is not eligible or it's inadvisable clinically for a TNF, you can go right to RINVOQ. So it's a really, really powerful position and set for AbbVie right now and over time. So that's basically what we're observing in the marketplace.
Roopal Thakkar: And Chris, it's Rupl. For subcutaneous, for SKYRIZI, we'll 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.
Robert A. Michael: And Chris, is Rob regarding your question on 2026. Look, 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 SKYRIZI and RINVOQ. We're seeing overperformance across the entire neuroscience portfolio and oncology is ahead of our original guidance as well. That momentum should allow us to deliver strong growth next year despite headwinds from continued HUMIRA erosion and IMBRUVICA IRA pricing. Recall that IMBRUVICA was negotiated in that pricing will kick in next year. And Humira erosion will continue albeit not at the same absolute level as we saw in 2025.
When I think about just the growth platform in particular, obviously a lot of attention is placed on SKYRIZI and RINVOQ appropriately. But in neuroscience, when you think about the forms of Vraylar, our migraine franchise, inclusive of Botox Therapeutic, which a little bit over 40% of that business is for chronic migraine. And then Violet, we're just seeing tremendous ramps, and we're also starting to now see, as Jeff mentioned, we expect the inflection, particularly with The US, 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, momentum is there.
We've now beaten and raised it every quarter. Of '25. And of course, it will provide specific guidance for '26 on the fourth-quarter call.
Liz Shea: Thanks, Chris. Operator, next question please.
Operator: Yes. Our next question comes from Vamil Divan with Guggenheim Securities. Your line is open.
Vamil Kishore Divan: Great. Thank you for taking my questions. So I have two, if I could. One, just around for the comment. 2025, and now 2026. My question is, like, here is around the 2027 guidance. You're giving first coverage in revoke. Before you can give it clearly. Contract to exceed that. I'm curious, you know, thoughts around updating this free zone. To your longer-term outlook for coverage in Ringgold. And then the other question on the aesthetic side, can you just comment on the latest market share since you have both Botox and do it again? In The US? Thank you.
Robert A. Michael: Vamil, this is Rob. I'll take your first question. So as you recall, we updated the 2027 guidance for SKYRIZI and RINVOQ during the Q4 call earlier this year. And since then, we have raised their 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 2026 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 a robust growth and deliver high single-digit compound revenue growth from '24 to twenty-nine. And we gave product specifics to support that high single-digit growth outlook. 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 that's 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 SKYRIZI and RINVOQ, though they do continue to perform above our own expectations. And there's recognition that our diversified growth platform drives top-tier performance.
That said, there are a few things that remain underappreciated, I think one is our strategy to continue innovating in immunology and drive growth beyond SKYRIZI and RINVOQ, both in terms of combination approaches with SKYRIZI or RINVOQ as a backbone and through new platforms such as oral peptides and B cell depletion approaches. We also have luticizumab in our pipeline, We have a TL1A. We have a TREM1 antibody. So I think there's quite a bit of depth here in the immunology pipeline that can set us up to grow beyond SKYRIZI and RINVOQ. Don't think that's always appreciated. 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 should be given it's our second largest therapeutic area and the fastest growing in our portfolio. We have very strong positions in psych and migraine. And an emerging leadership position in Parkinson's with Vylev and savapanon. We also have an opportunity to transform care for essential tremor. The Aliata platform also gives us the potential to advance Alzheimer's treatment. And our Gilgamesh and Gideon Richter deals give us more depth in mood disorders.
Say at the same time, we are starting to see more attention on our oncology pipeline, including tmAbA in several solid tumors, entansimig in multiple myeloma, seven zero six in small cell lung cancer, as well as the recent BD transactions trispecific antibodies from SimSir and IGI. 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 acquiring more external innovation that can help drive long-term growth. So to me, it's more important that investors appreciate the depth of our pipeline that can drive growth in the next decade versus updating financial guidance again for this decade.
Jeffrey Ryan Stewart: Vamil, it's Jeff. I'll just give you some of the sense you asked about the dynamic in The US with aesthetics. So it really just to start with the market. If you look at The US toxin market, it's really in a flattish position, in The US. 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 reimagined, but sequentially, we're growing. So we sit in the low 60s. Terms of Botox share, and that's a clear leadership position by a large margin in The US.
When you look at the filler, generally that's in the mid-40s, call it 45%, and that's largely been very stable. So that gives you some sense of the dynamics. The big thing is, as the leader, we have to invest we are investing in the market, as I mentioned in my remarks. We have a significant BOTOX consumer campaign in the market. We're starting to see some nice pickup there, so we're encouraged. We have filler sentiment campaign to make sure that we're working with all of their clinics to make sure we can revitalize and get that market stabilized and more robust. Because you really do need fillers to really get the aesthetic outcome.
So we believe we can rehabilitate that segment. And we also have opened three very significant training and sort of practice growth centers around the country to continue to lead that market. So that gives you a sense of the metrics that you were asking for.
Liz Shea: Thanks, Vamil. Operator, next question, please.
Operator: Yes, our next question comes from Matt Phipps with William Blair. Your line is open.
Matt Phipps: Hi. Thanks for taking my question. Congrats on another great quarter. That Gilgamesh acquisition is closed, 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 I just see this fitting into the overall MDD treatment paradigm given the in-clinic administration? Thanks.
Roopal Thakkar: Yeah, thanks Matt, it's Rupl. We're very excited about this approach. With other psychedelics, they tend to have a very long tail especially around hallucination. And this one has a very short duration. So when it's in clinic, it will be a short duration. And a lot of clinicians are prepared to do this already, so we're not worried about having that being a barrier for uptake. There's so much depression and unmet need we think that patients and caregivers would really like more options like this one. The other benefit that we saw is a longer duration after just one or two doses. And that maybe speaks to this potential concept of rewiring we're very excited about that.
So the key for us is in depression, looking at different doses and looking at different duration paradigms. And we're gonna do that in phase two. And, ultimately move into phase three. There is this regulatory need for a low dose comparator and that's because of the potential unblinding. And the phase two study that we've that Gilgamesh has 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 and different lines of depression and potentially other mood disorders that we're gonna investigate, to go beyond just major depression.
Liz Shea: Thanks, Matt. Operator, next question please.
Operator: Our next question comes from David Aslam with Piper Sandler. Your line is open.
David Aslam: Thanks. So wanted to drill down on your Parkinson's franchise. Can you talk to uptake of the Alev and specifically what you're seeing regarding competitive dynamics given the availability of MAPCO? So that's number one. And then on tivapadone, which you've talked about increasingly, you've got adjunctive therapy and also monotherapy here, so pretty versatile. But also bearing in mind that with oral therapies, it's highly genericized. So how are you thinking about sales potential there and ultimately where you see a role in practice for tevapadone? Thank you.
Jeffrey Ryan Stewart: Yeah, thanks for the question. I'll start off and then turn it over to Rupal. So as Rob and I mentioned, we're very, very pleased with Violet around the world with sales ramping very, very well. And it's levodopa, carbidopa. So it's the gold standard. It's just the ability to get that in the subcu version causes incredible disease stability and recovery. So we do see a lot of distinction versus let's say, the competitors. And we've dealt with the competitors around the world. It's new in The US. So in terms of what we see on the market perspective, the in-play capture right now is roughly 80-85% in favor of VioLev. And that's because of the twenty-four-hour coverage.
You have far less supplemental orals. The levels of control are great, particularly when you wake up and you're through the night. We're quite confident both short and long-term position for a product like Violet. It really is an exceptional medication. So I'll turn it over to Rupal to talk about the Ian and I can talk about where the positioning might be.
Roopal Thakkar: Yeah, thanks, Jeff. Hi, it's Ruple. Let me start on the Vylev side briefly, dovetailing on what Jeff just went through. So on the R&D side, we've received very favorable feedback thus far from caregivers and patients. And I would say the word transformative is the common theme. And the benefit of Violet is a full twenty-four-hour opportunity for state of control. And that facilitates the ability to sleep, and the ability to wake up on, ready to go, and face the day. The competitor that you mentioned is a sixteen-hour profile so may not afford that same twenty-four-hour control. Also, as Jeff had mentioned, Vyleb delivers a meaningful dose of levocarbidopa.
So what that means is patients, many patients, no longer require their oral therapy. So that means a monotherapy simplified approach is possible. The competitor is provided as an adjunct. So it you won't be able to get off of your oral therapies. Also with Vylev, when you look at the maintenance phase, dyskinesia rates are very low. And with the competitor you mentioned, they're roughly 15 up to thirty percent. The other benefit of Vylev from a competitive standpoint is we see less than a five percent rate of sedation. And with the apomorphine, it's around twenty percent. In also Violet we have limited headaches and this is in the teens, with apomorphine.
Also another benefit of Violet is no warnings for orthostatic hypotension or falls. That can't be said about the competitor. And also we have very low rates and no need for treatment for nausea. 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 I think it's very important that we mention, to vapidom, I spoke about just it's being submitted. This will be a very nice complement to Vialev. As a monotherapy and as an adjunct. It's a once-a-day profile. It has a long half-life.
And it's gonna allow patients to optimize their regimen before the need to move into advanced therapies. And where our clinicians are excited about differentiation from existing oral, generics is the efficacy which approaches levocarbidopa and the safety profile that could be a key differentiator and that's what our experts are telling us about. Specifically impulse control disorders, just around one percent. We've seen others reach as high as thirty or forty percent. The immediate people fall asleep, with this one, sedation is less than five percent. Dyskinesia around two percent, and peripheral edema, which can be quite a nuisance with the generic molecules and very difficult to treat even if you use potent diuretics.
We don't see that as a problem one percent or less with tevapadon. So we think for efficacy, safety, tolerability reasons, it has a chance to differentiate and again, a very nice complement to Violet.
Liz Shea: Thanks, David. Operator, next question, please.
Operator: Yes. Our next question comes from Dave Risinger with Leerink Partners. Your line is open.
David Reed Risinger: Yes, thanks very much. So I have two questions. The first is, could you please discuss the outlook for accelerating growth as HUMIRA's absolute dollar declines diminish in coming years? And then second, could you, Rupl, just comment on the top few pipeline candidate readouts that we should focus on over the next six months? I'm assuming Amylin is one of them, but what are the biggest cards that are turning over in the next six months or so? Thanks so much.
Scott T. Reents: David, this is Scott. I mean, I'll share some thoughts on your question about accelerating growth. So you know, you're right. HUMIRA continues to erode and step down this year with our guidance is going to step down just over in The U.S. Just over $4 billion. Certainly, that step down in absolute dollars will diminish, you know, and will diminish next year as well, of course, given the math. We will see certainly though significant percentage erosion from year to next year as well. That will continue to erode as the tail starts to form in 2026. So when you look at the business, I mean, 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 several times is our long-term guidance for high single-digit growth through the decade. That will be, you know, 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 will continue to expand. This year, our EPS is roughly in line, a little bit ahead of the earnings growth. But we're gonna 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.
Roopal Thakkar: Dave, it's 2026. In immunology, our IBD platform will start rating out data next year. This is in combination with SKYRIZI looking at dose combos versus monotherapy. SKYRIZI Lutikizumab is one of those, and the other is our own alpha four beta seven three eight two. So we'll start seeing that data next year. Also, in combination with lutekizumab, plus Rava in rheumatoid arthritis, that'll be something else to look for. And then maybe turning to oncology for a moment, For tmAbA, we've I went through a variety of different positive readouts.
Also next year, expect a readout in head and neck cancer and even ovarian cancer, which many of these patients have a high c Met expression, along with tantamig in a variety of different combinations in multiple myeloma. And then our next gen, coming after Elihir, our biparatopic FR alpha antibody 151, we'll start seeing readouts there in platinum-resistant ovarian cancer. 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 bispecific ADC that binds to PSMA and STeEP, for prostate cancer. And that's another one, I would say, to look for next year.
And then in neuroscience, we have our follow-on to Vraylar nine thirty-two. We'll start seeing data in bipolar depression probably moving into '27, looking for generalized anxiety disorder. Then we'll also be able to give an update on emeraclidine. We're currently conducting a multi-ascending dose trial to see if we can move the dose above thirty 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 two programs there in schizophrenia as an adjunct potentially as a monotherapy along with psychosis associated with neurodegeneration.
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. However, these patients will have normal BMI, and we've already seen reasonable weight loss there at six weeks, so we'll also have twelve-week data. The other thing Dave I'll mention is we're starting a phase 1B program late this year, maybe into January when we get everything started, but that will also look at our two ninety-five amylin acid. But the difference will be different titrations 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 events that we should keep our eyes on.
Liz Shea: Thanks, David. Operator, next question please.
Operator: Yes. The next question comes from Steve Scala with TD Cowen. Your line is open.
Stephen Michael Scala: 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 outlook in 2026? Which you have yet to share externally, but will it impact the numbers that you otherwise would have shared externally? Secondly, why was RINVOQ's phase three in HS updated to complete in 2028 from 2026 previously? Was it an issue with endpoint enrollment, or something else? Thank you.
Robert A. Michael: So, Steve, this is Rob. I'll take your first question, and Ruplu will take your second question. So as it relates to the Vraylar and LINZESS negotiations, keep in mind those prices will not take effect until 2027. Again, as I mentioned before, we have visibility to where it's landing. It's obviously not public yet, but we're not concerned about it impacting our long-term guidance. But there's no impact on '26 because those prices do not take effect in '26.
Roopal Thakkar: Steve, it's Rupel. We still anticipate our double-blinded week 16 data at the end of next year in HS. We'll get other double-blinded cuts, and then there's open-label extension. So sometimes that changes on duration on how long we follow patients could result in some updates to ct.gov.
Liz Shea: Thanks, Steve. Operator, next question please.
Operator: Yes. Our question comes from Simon Baker with Rothschild and Redburn. Your line is open.
Simon Baker: Thank you for taking my questions. Two if I may please. Firstly on Rinvokin non-segmental vitiligo. In some markets that's up to two percent of the population. So I wonder if you could give us an idea on your thoughts of the size of that opportunity. And then secondly, on Ella here, I note in the press release that you are launching it in The UK at a list price equal to the US. Now on the basis that people in The US don't generally pay the list price should one assume the same situation in The UK?
And going forward in The UK and Europe, do you envisage moving more to a US-style gross to net type market from the more net market that we see at the moment? Thanks so much.
Jeffrey Ryan Stewart: Yeah. So hi, it's Jeff. I mentioned that, as we look at the what we call the next wave of innovation around RINVOQ and we've seen some of those readouts which are really, really encouraging. GCA, which is the smallest of the next set of indications, 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, vitiligo, as you highlighted, HS, as Steve highlighted, and then lupus. We've looked and sized those that revenue potential is at least $2 billion at peak.
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, I. G. Other JAKs that are out there. So we're going through the sizing issue. We certainly see that there are different segments of vitiligo, like the high body surface area is more amenable to, let's say, an inhibitor like RINVOQ, which will be the first systemic. Is it active or is it stable?
So net, I mean, could say that all of these together would be greater than $2 billion, and we're gonna continue to hone those forecasts as we go towards launches over the next year or so.
Liz Shea: Thanks, Simon. Oh, one more. There's one more question.
Jeffrey Ryan Stewart: On Ella here, you're right, the price, in The UK, the list price is similar to The US. One of the aspects that we are looking at is how basically, because of the you know, most favored nation and other global pricing dynamics, how that may or may not change our approaches around the world. Certainly, would like to see reforms in many of the European countries, whether they are clawback systems or even the way that the HTAs work, because we do think that these medicines should be more highly valued.
Exactly how that will ultimately play out, certainly some of the early discussions with the administration are around basic more stable and equitable pricing around G7 inclusive of Switzerland and Denmark. So all of that strategies are basically in place. Ultimately, how that will play out we're gonna continue to see. Certainly, The UK, 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.
Liz Shea: Thanks, Simon. Operator, next question, please.
Operator: Yes, our next question comes from Luisa Hector with Berenberg. Your line is open.
Luisa Hector: Thank you. I'd like to ask in immunology, just if you could outline your next steps with your CAR T and your oral peptide platform. And then just a sort of longer-term question, but what level of market penetration do you think is ultimately achievable for the advanced therapies? In the more mature sorry, in the more mature indications, where could we actually get to and would that require success from the combinations to raise efficacy ceiling or some of these new platform technologies? Thank you.
Roopal Thakkar: Hi, Louise, it's Rupol. I'll start with the in situ CAR T from Capstan. Maybe some benefits and then we can talk about our plans. We have an opportunity to optimize that dose. It's 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 B cells and then the naive B cell population repopulates and you don't have the CAR on board any longer, and that's the advantage of the mRNA therapy. In the early phase one, we have observed B cell depletion. And the other benefit is no need for lymphodepletion.
So taken together, 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 rheumatology side of things like RA, and lupus. 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, I would say on Capstan.
On the oral side, the nimble acquisition these are macrocyclic molecules the ones that we're 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 half-life. So those are the two things that are going on. The lead candidates right now are an oral IL-23, and a TL-1A. 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'll see will be second line and potentially even third line because lines of treatment are continuing to expand. We have many patients that have already received anti-TNFs in IBD and you see medicines like SKYRIZI also starting to penetrate into that frontline. And if that's not working, then you have JAK inhibitors like RINVOQ. So we'd be studying a relatively refractory population. So if you can get 10 plus points better, the higher the better, I think that would be a huge benefit because breaking through where current efficacy stands today is really been the challenge, and I would say some of the best assets we have are currently RINVOQ and SKYRIZI.
And then the idea of the market structure that you highlighted in your second question, To Rupl's point, I mean, these immunology markets are quite amazing because you essentially have a biopenetration 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. To give you the bookend, when you look at biopenetration, I'm gonna give you The US biopenetration rates roughly and the European and Asia are lower. Generally based on the way those markets are developing. The highest biopenetration rates are in Crohn's disease, which is above fifty percent.
So you still have quite 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, have a super dynamic market, is atopic dermatitis. Incredible high unmet need that just basically, with the availability of drugs like DUPIXENT, and RINVOQ, that may be in the high single-digit biopenetration for moderate to severe. So new technologies are gonna help communications are gonna help, line of therapy is gonna help. And that's why, to Rupl's point, we're very excited about certainly the baseline adoption of these technologies, but transformative future technologies as well.
Liz Shea: Thanks, Louisa. Operator, next question please.
Operator: Yes. Our next question comes from Mohit Bansal with Wells Fargo. Your line is open.
Mohit Bansal: Great, thank you very much for taking my question. I have a couple of them. So one is on oral IL-23, the competitor's one. So Rupl, you mentioned some limitations there. Can you talk a little bit about how you think about this competition over time versus SKYRIZI or RINVOQ. And then a portfolio question. So you do have amylin in this space now with GUBRA. How much do you think a portfolio of these assets a GLP or other assets, is important to fight and win in this particular segment given that the check the competitors or incumbents have a portfolio of multiple assets out there. Thank you.
Roopal Thakkar: Thanks, Mohit. It's Rupul. So I'll start. I think when we look at SKYRIZI, first of all, the psoriasis data are very strong. Just to think about some of the numbers that we have, by week 16, if you're looking at clear or almost clear, you're approaching ninety percent. If you're looking at week 52, passing 90, that's at eighty percent and if you're at PASI 100, that's at sixty percent. So these are very, very high efficacy. And you also see over time if you're an early PASI responder, the majority of these folks are gonna maintain 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, why we like NIMBLE of potential half-life extension is that if you take orals, some people may miss some doses. And if you have a very short half-life, your treatment withdrawal data will sync very quickly. And if you miss many doses, you will lose effect. And with SKYRIZI, and actually this is even in our label, if you stop dosing, for one year you still have sixty percent of patients that are clear or almost clear. Now if you keep dosing, obviously, you'll get to that eighty to ninety percent range.
So I think it's important just to set up where is SKYRIZI today and you have this opportunity to have quarterly dosing so the patients 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. The other benefit is SKYRIZI 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 palmar plantar. That means scalp and genital across the board. The other insight about psoriasis is about thirty percent or so will have psoriatic arthritis, so they'll have joint disease.
And now with SKYRIZI, we have five years of data where eighty-eight, approaching ninety percent of patients do not have X-ray progression. And I would say taking in totality that 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 has stated, will have uptake like many of these assets because psoriasis, unlike IBD, is still quite underpenetrated and it's a growing market. And maybe Jeff, if you wanna make a comment as well.
Jeffrey Ryan Stewart: No, I think very clear, Ruplu. We're very confident in our competitive position. We've seen other orals enter the market. We have multiple head-to-head trials in terms of where those orals will compete and what the differences are. And so I think Rupl phrased it very, very nicely with his summary.
Roopal Thakkar: And then, on the amylin, yes, we think it would be of a benefit, and we do continue to look with partnered programs and external opportunities where you could potentially combine with the amylin and the focus there is tolerability and durability. We continue to see, only about thirty percent of patients with obesity continuing their incretins after one year, so these beneficial gains are not gonna result in long-term favorable outcomes if patients can't stay on these. So our focus is on the amylin, but we continue to look for combination agents and also other orthogonal approaches if you have the opportunity to maintain bone, and muscle. And then we're also exploring the potential.
Operator: And our next question comes from Jeff Meacham with Citibank. Your line is open.
Jeff Meacham: Great. Can you guys hear me? The call just cut off. Alright. Well, 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, you know, from your peers on things Medicaid and onshoring on manufacturing. Just was curious if you expect to also have a formal agreement, if that's if that's a priority. And then the second thing on aesthetics, it still seems that we're seeing some more macro headwinds. I know you've made some commercial and DTC investments as well as new launches. But, you know, what would you say are the leading indicators of a rebound?
I'm just trying to assess what kind of green shoots you may be seeing. Thank you.
Operator: Jeff, do you mind Sir, you can please start your question again.
Jeff Meacham: Sir, go ahead with your question.
Jeff Meacham: Can you guys hear me at all?
Operator: Now we can hear you. Hi, Jeff. Sorry.
Jeff Meacham: Okay. Alright. Yes. No worries. Unfortunately, this. Yep. No worries. Okay. So I just have two quick ones. Rob, on the policy side, I know we have some public agreements with the administration from your peers on Medicaid, on Shorgen manufacturing. I was curious if you expect to also have a formal agreement if that's a priority for you guys. The second thing on aesthetics, it still seems that you know, we're seeing more macro headwinds, and I know you've made some commercial and DTC investments and also know, 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 seeing.
Thank you.
Robert A. Michael: 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 US leadership in medical innovation. We were having discussions before the July 31 letter and have had more discussions since. I'd say we are aligned on the need to address global freeloading and have been working closely with the US TR on ways to address that, which ultimately, I think, a Section three zero one investigation in unfair practice will be important as we partner with the administration to make progress in terms of pricing outside The US.
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 US by building a new API plant in North Chicago. And expanding biologics capacity in Worcester as part of our $10 billion capital commitment. So you see the company's commitment to innovation, driving future growth and that's certainly something we're in discussions with the administration about. We also, as we mentioned, previously, announced that Ella here has been priced in The UK at the same list price as The US. I'd say all these actions are directionally aligned with the administration's stated goals.
And we'll continue to work with the administration on solutions that improve access and affordability while also supporting future innovation. And we will certainly share more information as we have it.
Jeffrey Ryan Stewart: And Jeff, 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 expected. 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. It's quite low, so that can be a leading indicator. We know 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 seeking particularly 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 were monitoring every month sort of the 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 that we look at for early indicators to sort of anticipate the market rebound. And again, we're going to invest through that. We think that's a good idea. Certainly, we also believe that, Trinibot, the ability to activate new consumers which will come next year for The U.S. Market, is a significant catalyst to try to lead this market back to health.
Liz Shea: Thanks, Jeff. Operator, we'll take the next question, please.
Operator: Thank you. Our next question comes from Courtney Breen with Bernstein. Your line is open.
Courtney Breen: Hi all, thanks so much for taking our question today. Perhaps one more on the policy side and then just a follow-up on RINVOQ. You were to simply look at AbbVie's ratio of the business right now, about a 75% US exposure, versus 25% ex-US. How different do you expect that to be in five years' time? How much of that might be down to the product mix, and how much of that might be down to kind of equalizing price or some of these new US policies? And then the follow-up on RINVOQ was just about the expansion opportunity associated with the changes to the RINVOQ label. Can you just help us quantify that a little bit more clearly?
Thank you.
Robert A. Michael: 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, saw it more like two-thirds, one-third. We haven't publicly disclosed, you know, what that US, OUS ex mix will look like over the long term. Obviously, it's portfolio dependent. I'd say that is the larger driver of fluctuations that you see there versus assumptions around price. And so, you know, as we drive this business, given the innovative platform, there's opportunities to grow in The U.S. There's great opportunities to grow internationally.
But, you know, the way to think about it is if you think about 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.
Jeffrey Ryan Stewart: And then in terms of the enhanced, IBD label, now we haven't fully quantified it, but I would say it's clearly a net incremental positive. We weren't sure, frankly, that we would get this type of language as we worked with the US 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 and Rupl mentioned, which is you're seeing a very significant transformation over the structure of IBD space. Whereas a few years ago, was a heavy TNF focus. And now you see this ascension of the IL-23s. You certainly still have Entyvio in there.
And so this is a net positive, we're going to continue to monitor effective this is with that one-two punch with that in-place share that we're continuing to be very pleased with.
Liz Shea: Thanks, Courtney. Operator, we have time for one final question.
Operator: Yes. Our last question comes from Asad Haider with Goldman Sachs. Your line is open.
Asad Haider: Great. Thanks for taking the question. Just maybe, Rob, for you on M&A, just any updated thoughts following the recent acquisitions, KapStan, Gilgamesh, just curious as to what your latest thinking is on business development. You've always referenced PD priorities that are geared towards the 2030s. 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.
Robert A. Michael: Thanks, Asad. This is Rob. I'll take that question. You're 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 focused our efforts on novel mechanisms and platform technologies that can drive longer-term growth, and that includes B cell depletion which Ruble mentioned, and oral peptides capabilities in immunology. The TriSpecifics, and an vivo CAR T platform in oncology.
You look at neuroscience, there's novel mechanisms for mood disorders in Alzheimer's. That we've licensed in. And we have a very compelling siRNA platform that can generate opportunities across all three of those therapeutic areas. And we've also utilized BD to enter another growth area obesity, which as Rupal mentioned, we will build upon. Again, given the strong outlook of the portfolio, we'll continue to focus on BD efforts. That really drive long-term pipeline opportunities. And the areas of focus are our core areas, immunology, neuroscience, oncology, aesthetics, and we've now added obesity. And so we think about those are the areas.
If you look about the 30 deals we've executed, more than 30 deals we've executed over the last eighteen plus months, there's been a nice mix between immunology, oncology, 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 well into the next decade.
Liz Shea: Thanks, Asad. And that concludes today's conference call. If you'd like to listen to a replay of the call, please visit our website at investor.abbvie.com. Thanks again for joining us.
Operator: Thank you. That concludes today's conference. You may all disconnect at this time.