Earnings Call Transcript
AbbVie Inc. (ABBV)
Earnings Call Transcript - ABBV Q3 2025
Operator, Operator
Good morning, and thank you for joining us. Welcome to the AbbVie Third Quarter 2025 Earnings Conference Call. Today's call is being recorded. If you have any objections, you may disconnect now. I would like to introduce Liz Shea, Senior Vice President of Investor Relations. Thank you. You may proceed.
Elizabeth Shea, Senior Vice President of Investor Relations
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. 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. Additional information about these risks and uncertainties is included in our SEC filings. AbbVie undertakes no obligation to update these forward-looking statements, except as required by law. On today's conference call, non-GAAP financial measures will be used to help investors understand AbbVie's business performance. These non-GAAP financial measures are reconciled with comparable GAAP financial measures in our earnings release and regulatory filings from today, which can be found on our website. Following our prepared remarks, we'll take your questions. So with that, I'll turn the call over to Rob.
Robert Michael, Chairman and Chief Executive Officer
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 and aesthetics 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 2 years, including new product approvals for tavapadon and PVEK, expanded indications for Rinvoq, Epkinly, Qulipta and Ubrelvy and pivotal data for lutikizumab, Temab-A 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 bretisilocin, expanding our psychiatry pipeline with a next-generation psychedelic currently in Phase II development for MDD. 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 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 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. 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.
Jeffrey Stewart, Executive Vice President, Chief Commercial Officer
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. 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 2 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 1 out of every 3 newer 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 3 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 prior year. Momentum from Venclexta as well as newer products, Elahere, Epkinly and EMRELIS 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 approximately $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 TrenibotE, 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 Ubrelvy, Qulipta and Botox Therapeutic all delivering robust double-digit growth. Qulipta is now the #1 CGRP treatment for migraine prevention with a total prescription share of approximately 7.5%. Vraylar is also performing well in both bipolar and major depressive disorders 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, VYALEV'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 24-hour delivery and the control of symptoms throughout the morning, day and night. VYALEV 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 VYALEV in the U.S. soon, which we expect will provide further revenue inflection next year. I'm also excited about tavapadon, 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 VYALEV 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 and our commercial execution has been outstanding. And with that, I'll turn the call to Roopal for comments on our R&D highlights.
Roopal Thakkar, Executive Vice President, Research and Development, Chief Scientific Officer
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 2 Phase III Rinvoq vitiligo trials. In both studies, Rinvoq met the co-primary and key secondary endpoints at week 48, 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 nonsegmental vitiligo. The daily challenges of living with this condition can often lead to depression and anxiety. With no approved systemic treatments, there is a 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 PVEK 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 3 orals for Temab-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 received 2 or more prior lines of therapy and regardless of c-MET expression levels, Temab-A in combination with bevacizumab demonstrated manageable safety and better responses and disease control compared to current standard of care. Treatment with Temab-A 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 Lonsurf plus bevacizumab. 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 Temab-A demonstrated an objective response rate of 24% in the overall population and 40% in patients who received first-line gemcitabine plus Abraxane. 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 Temab-A resulted in an objective response rate of 47% and median duration of response of 12.5 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 II study in MET amplified solid tumors is expected to begin later this year. We are making significant progress with Temab-A 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 Temab-A programs as data mature. In neuroscience, the regulatory application for tavapadon 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 D1/D5 receptor partial agonist demonstrated robust efficacy as a monotherapy in early Parkinson's disease and as an adjunct to levodopa-carbidopa oral therapy in patients still experiencing motor fluctuations. Once approved, we believe tavapadon will be an important new treatment option. Results from a Phase II study evaluating BOTOX in upper limb essential tremor were recently presented at the MDS Congress. 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. TrenibotE is a novel toxin that has demonstrated different pharmacologic properties preclinically compared to BOTOX, such as less diffusion to neighboring muscles. Phase II studies for TrenibotE in essential tremor and ventral hernia repair will begin next year. To further expand our neuropsychiatry pipeline, we acquired bretisilocin from Gilgamesh. Bretisilocin is a novel (5-HT)2A receptor agonist and 5-HT releaser with a short duration of hallucination that has demonstrated robust efficacy in a Phase II proof-of-concept study in major depressive disorder. 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 antidepressant effects following a short in-clinic treatment session. Additional Phase II 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 Reents, Executive Vice President, Chief Financial Officer
Thank you, Roopal. 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 $1.50 unfavorable impact from acquired IPR&D expense, primarily reflecting upfront charges for the acquisition of Capstan 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&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 for acquired IPR&D expense that may be incurred beyond the third quarter. We now expect total net revenues of approximately $16.9 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 Vraylar, Botox Therapeutic, VYALEV 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&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&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&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 end of September was more than $5.6 billion, and we generated approximately $13 billion of free cash flow in the first 9 months of the year, which includes nearly $2.2 billion of Skyrizi royalty payments. This free cash flow fully supports 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 the beginning of 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 2x by the end of 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.
Elizabeth Shea, Senior Vice President of Investor Relations
Thanks, Scott. We will now open the call for questions. Cedric, please go ahead with the first question.
Operator, Operator
Yes. And our first question comes from Terence Flynn with Morgan Stanley.
Terence Flynn, Analyst
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?
Robert Michael, Chairman and Chief Executive Officer
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, ultimately, what drives AbbVie's performance is our differentiated medicines, along with our execution track record and strong culture. And that's why we deliver similarly 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 Stewart, Executive Vice President, Chief Commercial Officer
Yes. 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 models like this that work today. And we think there's a lot of merit to that, like the ability for patients to share and lowering their out-of-pocket cost 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 across 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 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 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 it, but we're very confident in terms of if there were to be changes in the PBM model, we would adapt very well.
Robert Michael, Chairman and Chief Executive Officer
And Terence, this is Rob again. On your question regarding IRA, 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 Vraylar and Linzess will not impact our long-term guidance.
Operator, Operator
Yes. Our next question comes from Chris Schott with JPMorgan.
Christopher Schott, Analyst
I would appreciate a more detailed discussion on the IL-23 market. Clearly, Skyrizi is performing very well. However, with the introduction of TREMFYA's subcutaneous induction dosing, what are you observing regarding competitive dynamics and positioning? How do you see the relationship between your company and your closest competitor evolving over time? Additionally, I have a second question about your initial thoughts on 2026 as you consider the various factors influencing the business. Is there anything in particular that you believe the market may not be accurately reflecting as we evaluate the outlook for next year?
Jeffrey Stewart, Executive Vice President, Chief Commercial Officer
Yes, Chris, it's Jeff. I'll address your first question. We are very pleased with the overall growth of Skyrizi, posting a 46% year-over-year increase, which is quite strong. We see that momentum is reflected in our market share gains, and we maintain a very solid position in ulcerative colitis. We hold a leadership role; however, we anticipate that TREMFYA will also gain market share. The IL-23 class is expanding rapidly, which we view positively. This is not a zero-sum game, and we are confident in our competitive standing. To highlight how significant this change has been, just over a year ago, the new-to-brand prescription share for ulcerative colitis was around 5%. Now, it has surged to nearly 40%. This reflects a substantial increase in the adoption of IL-23 therapies. Skyrizi continues to perform well, and TREMFYA is expected to grow as well. Although there are some differences between the products, we are very confident about Skyrizi's future. Additionally, this is not just a story about Skyrizi; AbbVie has a unique advantage with both Skyrizi and Rinvoq. With Rinvoq's recent enhanced indication, our position for gastroenterologists and patients has strengthened significantly. This means that if a patient is not eligible or it is clinically inadvisable to use a TNF, physicians can directly opt for Rinvoq. Overall, this creates a powerful market position for AbbVie both now and in the future. That sums up our observations in the marketplace.
Roopal Thakkar, Executive Vice President, Research and Development, Chief Scientific Officer
And Chris, it's Roopal. For subcutaneous for Skyrizi, we'll see data next year for our own induction. And then that plus IV still leads to every 8-week dosing, which continues to be a major advantage.
Robert Michael, Chairman and Chief Executive Officer
And Chris, this 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 and 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 performance of Vraylar, our migraine franchise, inclusive of Botox Therapeutic, which a little bit over 40% of that business is for chronic migraine. And then VYALEV, we're just seeing tremendous ramps. And we're also starting to now see, as Jeff mentioned, we expect in the inflection, particularly with the U.S. We've seen some nice progress there. But I would say that will 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 beaten and raised it every quarter of '25. And of course, we'll provide specific guidance for '26 on the fourth quarter call.
Operator, Operator
Our next question comes from Vamil Divan with Guggenheim Securities.
Vamil Divan, Analyst
I have two questions. First, regarding the guidance you've provided for Skyrizi and Rinvoq in 2027, it seems like you're on track to exceed that. I would like to know your thoughts on updating the market about your longer-term outlook for these products. Second, could you share the latest market share information for both BOTOX and Juvederm in the U.S.?
Robert Michael, Chairman and Chief Executive Officer
So 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 the 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 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, 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 2 years of the LOE event. 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 can drive 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 lutikizumab 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. And I 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 VYALEV and tavapadon. We also have an opportunity to transform care for essential tremor. The Aliada platform also gives us the potential to advance Alzheimer's treatment. And our Gilgamesh and Gedeon Richter deals give us more depth in mood disorders. So at the same time, we are starting to see more attention on our oncology pipeline, including Temab-A in several solid tumors, etentamig in multiple myeloma, 706 in small cell lung cancer as well as the recent BD transactions for trispecific antibodies from Simcere 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 and 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 Stewart, Executive Vice President, Chief Commercial Officer
And Vamil, it's Jeff. I'll just give you some of the sense you asked about the dynamics in the U.S. with aesthetics. So really, just to start with the market. If you look at the U.S. toxin market, it's really in a 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 necessary reimagined. But sequentially, we're growing. So we sit in the low 60s in terms of BOTOX share, and that's a clear leadership position by a large margin in the U.S. When you look at the HA 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 and we are investing in the market, as I mentioned in my remarks. We have a significant BOTOX consumer campaign that's in the market. We're starting to see some nice pickup there. So we're encouraged. We have an HA 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 HA fillers to really get the aesthetics outcome. So we believe we can rehabilitate that segment. And we also have opened 3 very significant training and sort of practice 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.
Operator, Operator
Our next question comes from Matt Phipps with William Blair.
Matthew Phipps, Analyst
Congrats on another great quarter. Now the Gilgamesh acquisition closed, 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 MDD treatment paradigm given the in-clinic administration?
Roopal Thakkar, Executive Vice President, Research and Development, Chief Scientific Officer
Thank you, Matt. It's Roopal. We're very excited about this approach. Other psychedelics usually have a long duration, especially with hallucinations, but this one has a short duration. When it's used in clinics, it will be brief, and many clinicians are already prepared to use this method, so we don't see it as a barrier to uptake. There is a significant level of depression and unmet needs, and we believe that patients and caregivers would appreciate having more options like this. Another benefit we've identified is a longer effect after just one or two doses, which may relate to the idea of rewiring the brain. We're very enthusiastic about this. The focus for us in addressing depression will be to examine various doses and duration approaches, which we plan to explore in Phase II and ultimately in Phase III. There is a regulatory requirement for a low-dose comparator due to the potential for unblinding, and the Phase II study that Gilgamesh has already conducted used a low-dose comparator, resulting in significant outcomes. We're excited about this and see opportunities in various forms of depression and potentially other mood disorders that we aim to investigate, extending beyond just major depression.
Operator, Operator
Our next question comes from David Amsellem with Piper Sandler.
David Amsellem, Analyst
So I wanted to drill down on your Parkinson's franchise. Can you talk to uptake of VYALEV and specifically what you're seeing regarding competitive dynamics given the availability of an equivalent? So that's number one. And then on tavapadon, 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 tavapadon?
Jeffrey Stewart, Executive Vice President, Chief Commercial Officer
Yes. Thanks for the question. I'll start off and then turn it over to Roopal. So as Rob and I mentioned, we're very, very pleased with VYALEV around the world with sales ramping very, very nicely. And it is levodopa-carbidopa. So it's the gold standard. It's just the ability to get that in the subcutaneous version. Cause is 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 relatively new in the U.S. So in terms of what we see on the market perspective, the in-play capture right now is roughly 80%, 85% in favor of VYALEV. And that's because of the 24-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. The other metric that we look at is, in some cases, we've launched VYALEV after subcutaneous apomorphine has been available in the international countries. And essentially, the shares invert very, very rapidly. So we're quite confident in both short- and long-term position for a product like VYALEV. It really is an exceptional medication. So I'll turn it over to Roopal to talk about the tavapadon development and then ultimately, he and I can talk about where the positioning might be.
Roopal Thakkar, Executive Vice President, Research and Development, Chief Scientific Officer
Thank you, Jeff. It's Roopal. I'll briefly discuss VYALEV, building on what Jeff just shared. So far, we’ve received very positive feedback from caregivers and patients regarding our R&D efforts. The word transformative often comes up in these discussions, highlighting the full 24-hour control VYALEV offers. This level of control helps with sleep and allows patients to wake up feeling ready to take on the day. In contrast, the competitor you mentioned provides a 16-hour profile, which does not offer the same level of control. Additionally, VYALEV delivers a significant dose of levodopa-carbidopa, meaning many patients can discontinue their oral therapy, enabling a simplified monotherapy approach. On the other hand, the competitor is used as an adjunct, so patients can't stop using their oral therapies. When considering the maintenance phase, the dyskinesia rates with VYALEV are very low, while the competitor’s rates range from about 15% to 30%. From a competitive perspective, VYALEV also has a sedation rate of less than 5%, compared to around 20% for apomorphine. VYALEV has limited headaches, whereas apomorphine sees rates in the teens. Moreover, VYALEV has no warnings related to orthostatic hypertension or falls, which cannot be said for the competitor. We also observe low rates for the need for nausea treatment, while apomorphine initiation requires an antiemetic, which often needs to be taken three times a day. As Jeff noted, we are positioned very favorably with VYALEV for all the reasons I’ve mentioned. I also want to emphasize tavapadon; it has been submitted and will nicely complement VYALEV as both a monotherapy and adjunct. It is a once-a-day medication with a long half-life, allowing patients to optimize their regimen before moving to advanced therapies. Our clinicians are excited about the efficacy, which is comparable to levodopa-carbidopa, and the safety profile could be a key differentiator. Experts have noted that impulse control disorders are around 1%, while others can reach 30% or 40%. With tavapadon, sedation is less than 5%, dyskinesia is around 2%, and peripheral edema, which is often problematic with generic molecules, is seen in 1% or less. We believe that due to its efficacy, safety, and tolerability, it has a strong chance of differentiating itself and will be a great complement to VYALEV.
Operator, Operator
Our next question comes from Dave Risinger with Leerink Partners.
David Risinger, Analyst
Yes. So I have 2 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, Roopal, just comment on the top few pipeline candidate readouts that we should focus on over the next 6 months? I'm assuming Amylin is one of them, but what are the biggest cards that are turning over in the next 6 months or so?
Scott Reents, Executive Vice President, Chief Financial Officer
David, this is Scott. I have some thoughts on your question regarding accelerating growth. You are correct that Humira continues to decline and is expected to decrease by just over $4 billion in the U.S. this year. This decline in absolute dollars will continue to diminish next year, as expected. We will also see a significant percentage drop from this year to next year. The erosion will persist as the tail begins to form in 2026. When analyzing the business, there are several strong drivers evident in our current growth. As we've mentioned before, we have long-term guidance forecasting high single-digit growth throughout the decade. This will stem from this year's growth, which we anticipate accelerating as we move forward. We remain very confident in our capability to achieve high single-digit growth on the top line over the decade. Additionally, our bottom line will continue to improve. This year, our EPS is roughly in line, slightly above earnings growth, but we expect operating margin expansion driven by efficiencies in SG&A. Consequently, you will see earnings growth outpace revenue growth slightly over the decade aligned with our long-term guidance.
Roopal Thakkar, Executive Vice President, Research and Development, Chief Scientific Officer
And Dave, it's Roopal. I'll talk about some of the readouts we're excited about moving into 2026. In immunology, our IBD platform will start reading out data next year. This is in combination with Skyrizi, looking at those combinations versus monotherapy Skyrizi. Lutikizumab is one of those and the other is our own alpha4beta7-382. So we'll start seeing that data next year. Also in combination with lutikizumab plus Arava in rheumatoid arthritis, that will be something else to look for. And then maybe turning to oncology for a moment. For Temab-A, I've gone through a variety of different positive readouts. Also next year, expect to readout in head and neck cancer and even ovarian cancer, which many of these patients have high c-MET expression, along with etentamig in a variety of different combinations in multiple myeloma. And then our next-gen coming after Elahere, 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 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 STEAP for prostate cancer. And that's another one to look for next year. And then in neuroscience, we have our follow-on to Vraylar-932. We'll start seeing data in bipolar depression, probably moving into '27, looking for generalized anxiety disorder. We will also be able to give an update on emraclidine we're currently conducting a multi-ascending dose trial to see if we can move the dose above 30 milligrams, which has already initiated, and we'll be able to provide an update on where the dose lands. Once it does, we can start moving into Phase II programs there in schizophrenia as an adjunct and potentially as a monotherapy along with psychosis associated with neurodegeneration. Then on the obesity front, the Phase I 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 at 6 weeks. So we'll also have 12-week data. I'll mention we're starting a Phase Ib program late this year, possibly into January when we get everything started. This will also look at our 295 Amylin asset, but with different titrations and in patients that have obesity. That data will likely read out in Q4 of next year. So I would say there is a very robust number of events that we should keep our eyes on.
Operator, Operator
Your first question comes from Simon Baker with Rothschild & Co Redburn.
Simon Baker, Analyst
Two, if I may, please. Firstly, on Rinvoq in nonsegmental vitiligo. In some markets, that's up to 2% of the population. So I just wonder if you could give us an idea on your thoughts of the size of that opportunity. And then secondly, on Elahere, I note in the press release that you are launching it in the U.K. at a list price equal to the U.S. Now on the basis that people in the U.S. don't generally pay the list price, should one assume the same situation in the U.K. And going forward in the U.K. and Europe, do you envisage moving more to a U.S. style gross to net type market from the more net market that we see at the moment?
Jeffrey Stewart, Executive Vice President, Chief Commercial Officer
Yes, it's Jeff. As we consider the next wave of innovation surrounding Rinvoq, we've observed some very promising readouts. GCA, which is the smallest of the upcoming indications, is performing very well and is contributing to strong momentum in rheumatology. When we examine what we refer to as the next big four—alopecia areata, vitiligo, HS, and lupus—we estimate their peak revenue potential to be at least $2 billion. We are continuously analyzing the data and monitoring market developments to see how they might evolve. The data on alopecia is particularly impressive, especially in comparison to the standard of care and other JAK inhibitors available. We are also assessing the different segments of vitiligo, noting that high body surface area cases are likely more suited for a JAK inhibitor like Rinvoq, which would be the first systemic option available. Overall, it appears that the combined potential for these indications exceeds $2 billion, and we will refine these forecasts as we approach launches in the upcoming year.
Elizabeth Shea, Senior Vice President of Investor Relations
Thanks, Simon. Sorry, one more.
Jeffrey Stewart, Executive Vice President, Chief Commercial Officer
Just one more question on Elahere. 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 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 clawback systems or even the way that the HTAs work because we do think that these medicines should be more highly valued. So exactly how that will ultimately play out, certainly, some of the early discussions with the administration are around basically 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 going to continue to see. Certainly, in the U.K., as you know, you can have list prices, but ultimately, it's an HTA market, and we'll have to go through the NICE evaluation to see where that net price ultimately would land.
Operator, Operator
Our next question comes from Luisa Hector with Berenberg.
Luisa Hector, Analyst
I'd like to ask in immunology, just if you could outline your next steps with your CAR-T and your oral peptide platforms. 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 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?
Roopal Thakkar, Executive Vice President, Research and Development, Chief Scientific Officer
Luisa, it's Roopal. I'll start with insights on CAR-T from Capstan. We have an opportunity to optimize the dose, and since it's an off-the-shelf therapy, we observe rapid and transient expression. This could yield safety advantages over time, particularly if we can deplete the pathogenic B cells and allow the naive B cell population to repopulate without the CAR. This is an advantage of the mRNA therapy. In the early Phase I, we've seen B cell depletion, and another benefit is the lack of need for lymphodepletion. Altogether, this presents a very exciting opportunity for patients. Our next steps involve continuing to dose in the first-in-human studies, and next year, once we have a better understanding of dosing, we'll begin examining patients in rheumatology, such as those with rheumatoid arthritis and lupus. If it performs similarly to ex vivo CAR-T, we anticipate patients could achieve very deep and durable remissions, which is crucial and could elevate the efficacy standards. Regarding the oral side and the Nimble acquisition, we are focusing on macrocyclic molecules, aiming to enhance their potency and extend their half-life, as the current challenge with some oral platforms is their limited half-life. The two lead candidates right now are an oral IL-23 and a TL1A. In our IBD platform, higher efficacy is certainly better, but many patients we'll be treating will be in the second or potentially even third line, as treatment lines are increasing. Many have already tried anti-TNFs in IBD, and medications like Skyrizi are also starting to be used earlier. If those aren't effective, we have JAK inhibitors like Rinvoq. Therefore, we will be studying a relatively refractory population. Achieving a 10-plus point improvement would be significant since breaking through the current efficacy levels has been difficult. Currently, some of our strongest assets are Rinvoq and Skyrizi.
Jeffrey Stewart, Executive Vice President, Chief Commercial Officer
And then the idea of the market structure that you highlighted in your second question, to Roopal's 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. To give you the bookend, when you look at biopenetration, I'm going to give you the U.S. 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 50%. 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, you have a super dynamic market, which 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 going to help. Communications are going to help, a line of therapy is going to help. And that's why to Roopal's point, we're very excited about certainly the baseline adoption of these technologies, but transformative future technologies as well.
Operator, Operator
Yes. Our next question comes from Mohit Bansal with Wells Fargo.
Mohit Bansal, Analyst
I have a couple of them. So one is on oral IL-23, the competitors one. So Roopal, 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, GLP or other assets is important to fight and win in this particular segment given that the competitors or incumbents have a portfolio of multiple assets out there?
Roopal Thakkar, Executive Vice President, Research and Development, Chief Scientific Officer
Thanks, Mohit. It's Roopal. I'll begin by discussing Skyrizi. The psoriasis data is very impressive. By week 16, nearly 90% of patients are clear or almost clear. At week 52, about 80% achieve a PASI 90 response, and around 60% reach PASI 100. These numbers indicate very high efficacy, and we observe that most early responders maintain their results over the year and beyond, even after treatment withdrawal. This relates to our interest in Nimble's potential for half-life extension; with oral treatments, missed doses can occur, and a short half-life may result in a rapid decline in effectiveness. However, for Skyrizi, our data shows that even after stopping treatment for a year, 60% of patients remain clear or almost clear. Continuing treatment increases this to the 80% to 90% range. It is crucial to understand where Skyrizi stands today, especially with the option for quarterly dosing, allowing patients to forget about their psoriasis and not worry about meal schedules or fasting times. Skyrizi also delivers overall benefits across the board, with statistically significant results for palms, feet, scalp, and genital areas. Furthermore, about 30% of psoriasis patients also experience psoriatic arthritis, which affects their joint health. Skyrizi has five years of data showing that nearly 90% of patients do not experience x-ray progression. Overall, this positions us well to remain competitive against other injectables and even oral treatments. As Jeff pointed out, there is substantial potential for uptake in oral treatments, especially as the psoriasis market is still significantly underpenetrated and continues to grow. Perhaps Jeff would like to add some thoughts as well.
Jeffrey Stewart, Executive Vice President, Chief Commercial Officer
No, I think it's very clear, Roopal. We're very confident in our competitive position. And 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 Roopal phrased it very, very nicely with his summary.
Robert Michael, Chairman and Chief Executive Officer
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 30% of patients with obesity continuing their incretins after 1 year. So these beneficial gains are not going to 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 are also exploring the potentials.
Operator, Operator
And our next question comes from Geoff Meacham with Citibank.
Geoffrey Meacham, Analyst
Okay. Rob, on the policy sides, I know we have some public agreements with the administration from your peers on Medicaid and onshoring and manufacturing. Just was curious if you expect to also have a formal agreement, if that's a priority. And then 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 as well as new launches. But what would you say are the leading indicators of a rebound? I'm just trying to assess what green shoots perhaps you may be seeing.
Robert Michael, Chairman and Chief Executive Officer
Geoff, 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 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 USTR on ways to address that, which ultimately, I think a Section 301 investigation in 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 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 Elahere has been priced in the U.K. at the same list price as the U.S. 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'll certainly share more information as we have it.
Jeffrey Stewart, Executive Vice President, Chief Commercial Officer
And Geoff, 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. 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 the toxin, which is the leading indicator for the facial injectable business. And we also, as I highlighted in my remarks, we're monitoring every month sort of the HA 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 for early indicators to sort of anticipate sort of a market rebound. And again, we're going to invest through that. We think that, that's a good idea. Certainly, we also believe that TrenibotE, the ability to activate new consumers, which will come next year for the U.S. market is a significant catalyst to try to sort of lead this market back to health.
Operator, Operator
Our next question comes from Courtney Breen with Bernstein.
Courtney Breen, Analyst
Perhaps one more on the policy side and then just a follow-up on Rinvoq. If you were to simply look at AbbVie's ratio of the business right now, about a 75% U.S. exposure versus 25% ex U.S., how different do you expect that to be in 5 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 U.S. 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?
Robert Michael, Chairman and Chief Executive Officer
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 2/3 to 1/3. We haven't publicly disclosed what that U.S. OUS 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 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 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 Stewart, Executive Vice President, Chief Commercial Officer
In terms of the enhanced IBD label, we haven't fully quantified it, but it is clearly a net incremental positive. We were uncertain about receiving this type of language while working with the U.S. KOLs and the FDA, but we did, and we are very pleased about it. We see that this benefit will grow over time based on the dynamics previously mentioned, with a significant transformation occurring in the IBD space. A few years ago, the focus was heavily on TNF, whereas now we see the rise of IL-23s, along with ENTYVIO remaining relevant. This is a net positive, and we will continue to monitor its effectiveness alongside our in-play share, which we are very satisfied with.
Elizabeth Shea, Senior Vice President of Investor Relations
Thanks, Courtney. Operator, we have time for one final question.
Operator, Operator
Our last question comes from Asad Haider with Goldman Sachs.
Asad Haider, Analyst
Just maybe, Rob, for you on M&A. Just any updated thoughts following the recent acquisitions, Capstan and Gilgamesh. Just curious as to what your latest thinking is on business development. You've always referenced BD 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?
Robert Michael, Chairman and Chief Executive Officer
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 approaches, which Roopal mentioned, and oral peptides capabilities in immunology, trispecifics and an in vivo CAR-T platform in oncology. You look at neuroscience, there's novel mechanisms for mood disorders and Alzheimer's that we've licensed in. And we have a very compelling siRNA platform that can generate opportunities across all 3 of those therapeutic areas. And we've also utilized BD to enter another growth area, obesity, which as Roopal 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 you think about those are the areas. And if you think about the 30 deals we've executed, more than 30 deals we've executed over the last 18-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.
Elizabeth Shea, Senior Vice President of Investor Relations
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 investors.abbvie.com. Thanks again for joining us.
Operator, Operator
Thank you. That concludes today's conference. You may all disconnect at this time.