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Wednesday, Feb. 4, 2026 at 9 a.m. ET
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AbbVie (NYSE:ABBV) reported a record year with $61.2 billion in adjusted net revenues, exceeding guidance despite substantial HUMIRA erosion, while also highlighting robust top- and bottom-line growth, pipeline advancement, and increased R&D and business development spending. Management expects 2026 revenues to rise 9.5% to $67 billion, driven primarily by the continued expansion of SKYRIZI and RINVOQ, both of which have already exceeded prior long-term sales targets, as well as blockbuster prospects for the Parkinson's treatment Violet and significant migraine franchise growth. Strategic pipeline investments were outlined, including imminent data across immunology, neuroscience, and oncology, while a voluntary US government agreement will expand patient access and commit $100 billion to US R&D and capital projects over the next decade.
Robert Michael: Thank you, Liz. Good morning, everyone, and thank you for joining us. Our fourth quarter performance closes out another excellent year for AbbVie, and I am very pleased with the significant progress we made in 2025. We delivered record net sales and exceeded our financial commitments, advanced our pipeline across all stages of development, and acquired new sources of growth through strategic transactions. We are entering 2026 with substantial momentum and remain well-positioned to deliver another year of strong growth. Turning to our results, we delivered full-year adjusted earnings per share of $10, which is $0.54 above our initial guidance midpoint.
Excluding the impact of IPR&D expense, total net revenues were $61.2 billion, beating our initial guidance by more than $2 billion. Our sales growth of 8.6% led to a new all-time high for AbbVie, exceeding our previous peak revenue by more than $3 billion, despite nearly $16 billion of US HUMIRA erosion since the LOE. Our excellent performance puts us in a strong position to advance our innovative medicines. In 2025, we increased adjusted R&D expense by nearly $1 billion, fully funding the 90 clinical programs currently in development. We also obtained several new product and indication approvals, including RINVOQ for GCA, EMERALIS for nonsquamous, non-small cell lung cancer, and Epkinle for second-line follicular lymphoma.
And we bolstered our pipeline by investing more than $5 billion in new business development, including several promising mechanisms and technologies. These include an in vivo CAR T platform in immunology from Capstan Therapeutics, bradicilacin, a next-generation psychedelic with promising data in depression, ISB 2001, a novel trispecific antibody for multiple myeloma, 295, a long-acting amylin analog for obesity, and a next-generation siRNA platform from 8Rx that has applicability in immunology, neuroscience, and oncology. We also recently announced a transaction with Remagen, adding a novel PD-1 VEGF bispecific antibody to combine with our ADCs across multiple solid tumors, further strengthening AbbVie's oncology portfolio. Turning to 2026, we expect AbbVie to once again deliver top-tier performance.
We anticipate total sales growth of 9.5%, reflecting another year of robust sales results despite headwinds from continued HUMIRA erosion and IMBRUVICA IRA pricing. The main drivers of this growth include SKYRIZI and RINVOQ, with combined sales of more than $31 billion, already surpassing our 2027 long-term guidance by half a billion. We are also forecasting a substantial sales ramp for Vialev, achieving blockbuster status this year as a transformational treatment for Parkinson's. And we expect continued double-digit revenue growth from our leading migraine products, which are also trending significantly above our long-term expectations. Given the strong outlook of our diverse portfolio, we are well-positioned to deliver high single-digit revenue growth through 2029.
Turning now to R&D, we anticipate a number of key catalysts across our core therapeutic areas over the next 24 months. In immunology, this includes pivotal data for three additional RINVOQ indications as well as initial data for our Crohn's combination platform with SKYRIZI. In neuroscience, we anticipate key readouts for next-generation assets 932, bretacelacin, and miraclodene. And in oncology, we expect registrational data for etentamig, as well as mid to late-stage readouts for tmAbA in several solid tumors. These are all very exciting opportunities that have the potential to drive sustained long-term growth.
Lastly, we recently announced a voluntary agreement with the US government that reinforces our commitment to patient access and affordability while also protecting our ability to invest in innovation. Key elements of this three-year agreement include offering low prices in Medicaid, expanding direct-to-patient cash pay options for select products, and committing $100 billion in US R&D and capital investments over the next decade. In summary, we are delivering outstanding execution, and the outlook of our business remains very strong. With that, I'll turn the call over to Jeffrey for additional comments on our commercial highlights. Jeffrey?
Jeffrey Stewart: Thank you, Rob. I'll start with the quarterly results for immunology, which delivered total revenues of approximately $8.6 billion. SKYRIZI total sales were $5 billion, reflecting operational growth of 31.9%. RINVOQ total sales were nearly $2.4 billion, reflecting operational growth of 28.6%. On a full-year basis, SKYRIZI and RINVOQ delivered approximately $25.9 billion in total combined revenue, an impressive increase of more than $8 billion year over year, well exceeding our initial guidance expectations. These results reflect exceptional performance across their respective indications, and I'll highlight a few examples. Starting with psoriatic disease, a market that is growing high single digits with modest biologic penetration where our portfolio has clear leadership.
SKYRIZI total prescription share in the US biologic psoriasis market is now more than 45% and accelerating in the fourth quarter. Our in-play capture rates of new and switching patients have exceeded 55% across all lines of therapy, four times higher than the next closest competitor. And when you consider SKYRIZI's very high and durable skin clearance, including new and statistically significant data across the board, hard-to-treat areas like scalp, genitals, palmar, plantar, also widely demonstrated superior efficacy to both biologic and two oral agents. Along with that simple quarterly dosing, we do not expect a material impact to our robust outlook in psoriasis from any existing or new therapies this year and beyond.
Moving to PSA derm, where nearly 30% of patients visiting dermatologists have both skin and joint involvement, SKYRIZI is now capturing roughly one out of every four in-play patients on biologic across all lines of therapy in the US, further supporting SKYRIZI's strong momentum. The PSA indication represents a critical differentiator in the psoriasis market, especially relative to emerging options where PSA efficacy is still unproven. Importantly, SKYRIZI has achieved PSA frontline in-play patient share leadership for biologics in both the derm and the room segments. Turning more broadly to room, RINVOQ continues to achieve a leading mid-teen in-play patient share for RA across all lines of therapy in the US.
This is roughly double our total TRx share, highlighting a nice setup for incremental share capture in RA over the next several years, driven by our active communication of the select switch trial, with data demonstrating RINVOQ's doubling of remission rates versus treatment with a second TNF inhibitor. And lastly, in IBD, where we continue to deliver strong performance and remain very well positioned. The IBD market is very robust with high single-digit growth, driven by increasing biologic penetration and rapidly expanding lines of therapy as patients cycle to newer, high-efficacy agents like SKYRIZI and RINVOQ. We are very pleased with SKYRIZI's strong growth in IBD.
Global sales for this indication were approximately $6.4 billion in 2025, more than double our prior year performance in IBD. We remain very confident in SKYRIZI's profile in IBD, including its demonstrated strong impact on clinical remission, as well as extremely strong endoscopic data with best-in-class placebo-adjusted rates, particularly in the bionaiive patients. And you can see this clinical profile playing out well when you consider our current market shares by line of therapy. Importantly, and despite in-class competition for most of 2025, SKYRIZI capture rates remain exceptionally impressive, especially in that frontline treatment of IBD, which is the strongest signal of overall physician preference. And SKYRIZI remains the clear leader.
SKYRIZI retains a very high IL-23 category patient share, with an in-play capture rate of approximately 75% in the frontline setting overall for IBD. This is driven by an even higher frontline capture rate for SKYRIZI in Crohn's disease, which is roughly two-thirds of the total IBD market. And these capture rates have been strong and consistent even as the IL-23 category expands rapidly. SKYRIZI's dosing convenience is also favored, with less frequent maintenance treatment to the most effective dose for other IL-23s, which is very important as patients tend to be on therapy for many years. So SKYRIZI continues to perform very well and will continue to do so in 2026 and beyond.
Equally importantly and unlike any other competitor, we have a second compelling treatment in IBD, RINVOQ, which is also capturing robust mid-teens in-play share across all lines of therapy in Crohn's disease and ulcerative colitis. RINVOQ has demonstrated some of the strongest response rates to date in IBD, including rapidity of action, which is important for patients who need rapid control and durable remission. And with RINVOQ's recently expanded label in IBD, patients will now have access to RINVOQ earlier in the treatment paradigm, when anti-TNF treatment is clinically inadvisable. SKYRIZI and RINVOQ are a great pair in IBD. SKYRIZI is well-positioned in frontline, and we see more opportunity than ever before for RINVOQ in the second line plus setting.
So together, our two brands have already exceeded peak HUMIRA sales by more than $4.5 billion and are on pace to deliver more than 20% growth in 2026, remarkable considering this year will be their eighth year on the market. Turning now to HUMIRA, which delivered global sales of more than $1.2 billion, down 26.1% on an operational basis, primarily due to biosimilar competition and in line with our expectations. We anticipate HUMIRA access will decrease further throughout 2026 as more plans move to exclusive biosimilar contracts. Moving to neuroscience, where full-year revenues were more than $10.7 billion, reflecting impressive absolute sales growth of nearly $1.8 billion.
In the quarter, total revenues were more than $2.9 billion, up 17.3% on an operational basis. This robust performance is driven by continued double-digit growth of Vraylar, with global sales of $1 billion, Therapeutic with global revenues of $990 million, Ubrellvi, with global sales of $339 million, and QULYPTA, with global revenues of $288 million. Beyond these leading therapies for psychiatry and migraine, we are very excited for our emerging portfolio in Parkinson's disease, which we believe remains underappreciated. Violet's launch continues to be outstanding. Total sales were $183 million in the quarter, up approximately 33% on a sequential basis.
The uptake is exceptionally strong across international markets, and we expect sales to ramp in the US, where Violet recently received full coverage. Feedback from prescribers and patients' communities remain very encouraging, highlighting meaningful improvements in on-time and off-time, as a result of Violet's continuous 24-hour delivery and the control of symptoms morning, day, and night. Given these insights and the robust early launch trends globally, we now expect Violet to achieve blockbuster revenue in 2026. And when you add Tavapadon, for potential use as a monotherapy for early Parkinson's disease, as well as an adjunct to optimize oral therapy for more advanced patients, we believe we have the potential multibillion-dollar emerging PD franchise over the long term.
And we remain on track for commercial approval of tevapadon in the US later this year. Moving now to oncology, where total revenues were nearly $1.7 billion in the quarter, down 2.5% on an operational basis. VENCLEXTA global sales were $710 million, up 6.4% on an operational basis, reflecting continued strong demand in CLL, with combination use of VENCLEXTA plus BTK inhibitors emerging as a preferred all-oral fixed-duration treatment. In 2026, we anticipate another major commercial catalyst with the global approvals of VENCLEXTA plus Calquence in combination, two leading brands in CLL, offering patients the potential for time off treatment, addressing an important need.
Double-digit sales growth from Elijir, Epkinley, and Amrelis also helped to partially offset the expected sales decline for IMBRUVICA, which was down 20.8%, primarily due to continued competitive dynamics. And we do anticipate IMBRUVICA IRA price pricing will unfavorably impact our oncology portfolio growth in 2026. Turning now to aesthetics, which delivered global sales of nearly $1.3 billion in the quarter, down 1.2% on an operational basis. BOTOX Cosmetic global revenues were $717 million, up 3.8% on an operational basis. Juvederm global sales were $249 million, down 10.8% on an operational basis. We've seen over the last several quarters, economic headwinds have continued to impact market conditions globally, and we anticipate category growth will remain challenged in 2026.
With our leading market shares relatively stable for both toxins and fillers, we are focused on investing to stimulate the market, which remains highly underpenetrated. We expect to further catalyze growth with new promotional programs for Botox, including the Only You campaign that was launched over the last several months, with encouraging early results. An unbranded program to educate practices and consumers about the benefit of fillers, with a focus on driving natural outcomes, as well as additional injector training, which will be supported by our three new AMI training centers in the US as well as training programs in key international geographies. Bringing innovation to the aesthetics market with our pipeline is also a clear priority.
We look forward to commercializing Trinibot e, a fast-acting short-duration toxin, which is expected to be approved in the US later this year. So overall, I'm extremely pleased with the execution across our commercial portfolio, which is demonstrating very, very strong momentum as we head into 2026. And with that, I will turn the call over to Roopal for comments on our R&D highlights. Roopal? Thank you, Jeff.
Roopal Thakkar: I'll start with immunology, where we are on track for numerous important data readouts across all stages of our pipeline this year, as well as several regulatory submissions and approvals. Regulatory applications for RINVOQ in nonsegmental vitiligo were recently submitted, with an approval decision in the US anticipated in the fourth quarter. Regulatory applications for RINVOQ in alopecia areata are under review in Europe and Japan, with approval decisions expected later this year. Our US submission is planned for the second quarter. Over the course of 2026, results from several late-stage programs are anticipated, including phase three data from studies for both RINVOQ and lutekizumab in hidradenitis suppurativa, and a study evaluating subcutaneous induction with SKYRIZI in Crohn's disease.
We continue to make substantial progress with our early and mid-stage programs as well, where we have an exciting pipeline of next-generation therapies that have the potential to drive higher efficacy relative to standard of care. This year, we'll see data from our Crohn's disease platform study, evaluating SKYRIZI in combination with our novel anti-alpha four beta seven antibody ABBV 3A2 and our anti-IO one alpha beta bispecific, lutekizumab. Our extended half-life TL1A antibody will also be evaluated in combination with SKYRIZI, with a phase 2b dose-ranging study in Crohn's and ulcerative colitis beginning later this year. Separately, a phase two study is underway to evaluate our TREM1 antibody as a monotherapy in Crohn's disease.
Data from this study will be available later this year and will help inform our combination strategy for this molecule. The phase 1b trial for ABBV 319, our anti-CD19 ADC with a steroid payload, is now underway, and we will soon begin dosing patients with our in vivo CD19 CAR T, ABBV 619. These B cell depleting approaches have the potential to become transformative modalities to reset the immune system and provide deep, durable, drug-free remission for patients with autoimmune diseases. Individual patient data from dose escalation studies will be available on a rolling basis, and we anticipate seeing efficacy results later this year.
Several additional immunology assets will also be entering the clinic this year, including an extended half-life anti-IL-23 antibody and an oral peptide IL-23 inhibitor. Moving to oncology, progress continues with our next-generation cMet ADC tmAbA. Strong data have been observed in late-line colorectal cancer, as both a monotherapy and in combination with bevacizumab. Therefore, we will be initiating a phase three study this year in an all-comers population in combination with VEV. Dose optimization continues for tmAbA in non-small cell lung cancer, where both EGFR wild-type and EGFR mutant populations are being evaluated. Data from these studies will be available next year, informing our phase three path.
In pancreatic cancer, tmAbA will be studied in combination with different regimens of chemotherapy. Later this year, data is anticipated in head and neck and ovarian cancer. We're making very good progress across several tumor types with tmAbA. We recently announced a deal with Remagen for a PD-1 VEGF antibody. This molecule will be a nice complement to our ADC portfolio and has demonstrated competitive monotherapy efficacy as well as encouraging early data in ADC and chemo combinations. Our strategy is to initially combine this PD-1 VEGF with tmAbA in lung and colorectal, with other tumor types also under consideration. These novel combinations have the potential to drive faster disease control, longer duration, and ultimately longer survival.
In small cell lung cancer, a phase two trial for ABBV 706 in combination with atezolizumab recently began in treatment-naive patients. A phase three study in second-line plus patients is also planned to initiate this year. In hematologic malignancies, the regulatory application for PIVC in blastic plasmacytoid dendritic cell neoplasm is under review with the FDA. An approval decision is anticipated later this year. Enrollment is projected to complete this quarter in our phase three trial evaluating monotherapy atentamig in third-line plus multiple myeloma, with an objective response rate readout anticipated in the second half of this year. A Phase II study of ententamig plus daratumumab in frontline transplant-ineligible patients was recently initiated.
Additionally, a phase three study in second-line evaluating entantamig with pomalidomide is expected to begin by early 2027. Turning to neuroscience, in our movement disorder programs, an approval decision is anticipated in the third quarter for tevapadon in Parkinson's disease. As a highly effective treatment for motor symptoms, with low rates of dyskinesia, edema, sedation, and impulse control disorder, tevapadon has the potential to be an important new treatment option, both as a monotherapy and as an adjunct to levocarbidopa in patients still experiencing motor fluctuations. This year, a phase two study assessing gemmibot a in essential tremor will begin. Essential tremor is the most common movement disorder and an area with considerable need for effective and tolerable therapies.
Unlike most patients with spasticity, patients with essential tremor typically have normal strength. Therefore, it is important that neighboring muscles are not inadvertently affected, and this is by toxin diffusion. Our new toxin is highly potent and has the potential for less spread to neighboring muscles, making it well-suited for treating essential tremor. In migraine, the phase three ECLIPSE trial evaluating QLIPTA for acute treatment of migraine met its primary and key secondary endpoints, with Qlipta demonstrating superiority over placebo. Approval decisions in Europe and Japan are expected later this year. Our phase three studies evaluating Qlipta and UBRELVY for menstrual migraine prevention are progressing well, with data from both trials expected in the second half of this year.
Regulatory submission for Qlipta in Europe is anticipated later this year, and for UBRELVY in the US in 2027. Menstrual migraine is a distinct subtype affecting nearly 15% of women with migraine. Attacks are considered more difficult to treat, more disabling, last longer, and have a higher tendency to recur. There is a clear need for more effective treatment for this form of migraine. In the area of psychiatry, several readouts and study starts are planned this year across multiple programs. Our dose escalation study continues for ameraclidine in schizophrenia, with the 75-milligram dose cleared and 100 milligrams currently being assessed. Further dose escalation is planned until a tolerability threshold is reached.
Based on the favorable profile with 75 milligrams, and the potential to move the dose even higher, emeraclidine will be moving forward in development as both a monotherapy and adjunctive treatment for schizophrenia. Dose ranging in elderly patients is also ongoing, which will support development plans in psychosis related to Alzheimer's, Parkinson's, and dementia with Lewy bodies. Phase two studies across all indications will begin after the completion of multiple ascending dose evaluation. The phase two study for ABBV 932 in bipolar depression is nearing completion, and data is expected around the middle of this year. Data from the generalized anxiety disorder phase two is anticipated in the early part of 2027.
This year, data from two additional cohorts from a phase two study evaluating bradicilacin in major depressive disorder will help inform our development strategy and phase three plans. This short-acting psychedelic demonstrated very strong durable efficacy in a preliminary phase two study. Based on this emerging profile, reticilacin has the potential to become a groundbreaking new treatment in depression. Moving to other areas of our pipeline, in obesity, data will be available this year from two ongoing phase one studies evaluating our long-acting amylin analog ABBV 295 in overweight and obese patients. Results will guide our phase two program, which is expected to begin near the end of this year.
In aesthetics, the regulatory application for our rapid-onset short-acting toxin Trenebody is under review, and an approval decision is expected this year. To summarize, we continue to demonstrate significant progress across all stages of our pipeline and anticipate many important regulatory and clinical milestones in 2026. With that, I'll turn the call over to Scott.
Scott Reents: Thank you, Rupal. Starting with our fourth quarter results, we reported adjusted earnings per share of $2.71, which is $0.08 above our guidance midpoint. These results include a $0.71 unfavorable impact from acquired IPR&D expense. Total net revenues were $16.6 billion, reflecting robust growth of 10%, including a 0.5% favorable impact from foreign exchange. Our ex-HUMIRA growth platform delivered reported growth of 14.5%, once again exceeding our expectations. Adjusted gross margin was 83.6% of sales, adjusted R&D expense was 15.4% of sales, and adjusted SG&A expense was 22.3%. The adjusted operating margin was 38.3% of sales, which included a 7.6% unfavorable impact from acquired IPR&D expense. Net interest expense was $655 million.
The adjusted tax rate was 18.3%, reflecting the lower deductibility of the acquired IPR&D expense this quarter. Turning to our financial outlook for 2026, our full-year adjusted earnings per share guidance is between $14.37 and $14.57. Please note that this guidance does not include an estimate for acquired IPR&D expense that may be incurred throughout the year. We expect total net revenues of approximately $67 billion, reflecting growth of 9.5%. At current rates, we expect foreign exchange to have a roughly 0.8% favorable impact on full-year sales growth. This revenue forecast contemplates the following approximate assumptions for select key products and therapeutic areas.
We expect global immunology sales of $34.5 billion, including SKYRIZI revenue of $21.5 billion, driven by market growth and share gains across the psoriatic and IBD indications, RINVOQ revenue of $10.1 billion, with growth across room, derm, and gastro indications, and HUMIRA total revenue of $2.9 billion, reflecting continued biosimilar impact. For neuroscience, we expect global sales of $12.5 billion, reflecting robust double-digit growth. This includes Vraylar revenue of $4 billion, driven by continued strong prescription demand, Botox Therapeutic sales of $4.1 billion, with strong performance across indications, total oral CGRP revenue of $2.9 billion, supported by market growth and share gains, and BIOLIF sales of $1 billion, demonstrating the brand's impressive launch and multibillion-dollar potential.
In oncology, we expect global sales of $6.5 billion, including IMBRUVICA revenue of $2.2 billion, reflecting competitive headwinds and the impact of lower IRA-related pricing, VENCLEXTA sales of $3 billion, which reflects continued strong demand, and ELEHIR revenue of $850 million. For aesthetics, we expect global sales of $5 billion. This includes Botox Cosmetic revenue of $2.7 billion, reflecting modest market growth and relatively stable market share, and Juvederm sales of $950 million, reflecting continued headwinds in key dermal filler markets. Moving to the P&L for 2026, we are forecasting full-year adjusted gross margin above 84% of sales, adjusted R&D expense of approximately $9.7 billion, and adjusted SG&A expense of approximately $14.2 billion.
We also expect an adjusted operating margin ratio of approximately 48.5%, reflecting meaningful expansion compared to 2025. We expect adjusted net interest expense of approximately $2.8 billion, which includes anticipated refinancing. We forecast our non-GAAP tax rate to be approximately 14%, reflecting a modest underlying improvement compared to 2025 due to recent tax law changes. Keep in mind that last year's non-GAAP tax rate of 18% included a 3% impact from acquired IPR&D expense. Finally, we expect our share count to be roughly in line with 2025. Turning to the first quarter, we anticipate net revenues of approximately $14.7 billion. At current rates, we expect foreign exchange to have a roughly 2% favorable impact on sales growth.
This revenue forecast considers the following approximate assumptions for key products and selected therapeutic areas. We expect global immunology sales to approach $7.1 billion, including SKYRIZI sales of $4.4 billion and RINVOQ revenue of $2 billion, reflecting typical seasonality as well as an unfavorable price comparison for RINVOQ related to timing of prior year rebates in the first half. We also anticipate neuroscience revenue of $2.8 billion, oncology sales of $1.6 billion, and aesthetics revenue of $1.2 billion, reflecting growth of roughly 9%, including a favorable comparison as we lap one-time price headwinds associated with changes to the Alley program. We are forecasting an adjusted operating margin ratio of roughly 46% and model a non-GAAP tax rate of approximately 13.7%.
We expect adjusted earnings per share between $2.97 and $3.01. 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 December was $5.2 billion, and we expect to generate free cash flow of $18.5 billion in 2026, which includes roughly $3.5 billion of SKYRIZI royalty payments. This free cash flow will support a strong and growing quarterly dividend, which we have increased by more than 330% since inception, as well as investments in business development to further enhance our portfolio.
In closing, we are pleased with AbbVie's results in 2025, and our financial outlook remains very strong. We have significant momentum across our diverse portfolio and are well-positioned to deliver strong results in 2026 and beyond. With that, I'll turn the call back over to Liz.
Elizabeth 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. Operator? We'll take the first question, please.
Operator: Thank you. The first question in the queue is from David Risinger with Leerink Partners. Your line is open.
David Risinger: Thanks very much and congrats on the solid fourth quarter and the momentum of the company. I just have one question, which is you mentioned the psychedelic that's in development. Could you please provide some more details on that, the opportunity to improve upon the profile of J&J's bravado? Thanks very much.
Roopal Thakkar: Hi. It's Rupal. I'll take that one. We see this one as a potential breakthrough type of therapy. In a couple of elements. One is it works through the 5-HT2A serotonergic pathway and has a short-acting, I would say, hallucination time period where patients experience the potential hallucinations upfront and then it rapidly goes away. And what we've observed is that you see immediate efficacy and then you see that efficacy held on for quite some time. So that's a benefit. And these patients are then able to stay for a short time in the clinic and then leave. The other notable differences from any other medications in this space are the very high levels of efficacy that were observed.
And that almost led to a remission-like state in the majority of patients. Now we have two more readouts before the phase three begins. And in those readouts, what we're doing is reducing the dose of the control arm. And recall data that we've seen thus far were not against placebo, they were, in fact, against an active control of the drug itself. Which that data looked pretty good, but when you looked at the main dose, it looked very impressive. So we're gonna look at a comparator with a slightly lower dose of self-control and then that'll read out, I would say, by Q3 or so.
And then we'll have a phase three plan going forward that we'll discuss with regulators. But this has the potential to be highly differentiated.
Elizabeth Shea: Operator, next question, please.
Operator: Yes. The next question is from Christopher Schott with JPMorgan. Your line is open.
Christopher Schott: Great. Thanks. Much. Just a couple parter on the immunology franchise. I guess just first on SKYRIZI in IBD. It sounds like you haven't really seen any change in new start share here with the Tremfya entry. As my question, is that the case in both Crohn's and UC, or is that just more a holistic kind of IBD comment? And my kind of bigger picture question is, I've been reading more investors feeling that the Street now better understands the potential for SKYRIZI and RINVOQ over time. As a result, there's no longer as much potential upside to numbers. I guess I'd just feature in your view of consensus growth expectations for these assets over time.
Is the market now largely getting this right at this point? Or do you see further potential for growth upside as you think about the breadth of indications, etcetera? Thank you.
Jeffrey Stewart: Yeah. Hi, Chris. It's Jeff. So you know, we see some slight distinctions between the capture rate for SKYRIZI in Crohn's versus UC, and that's really probably largely based on when the launches took place with the competitor. But as I mentioned, and it may not be widely understood, we see definitely a bifurcation in where the capture rate is coming. It's quite clear that our new patient starts are very, very stable. And they're very high in both UC and Crohn's. If you look at where the starts are coming from, and I mentioned in my prepared remarks, we have very, very high capture rates.
Seventy-five percent overall in IBD in the frontline setting, which sort of gives you a sense of where the preference of the customers are. And it's 80% I didn't highlight that in my speech. It's 80% in Crohn's, so it's slightly lower in UC on the frontline setting. So we see the dynamics again as very stable and high new patient starts, despite the competitive entrant. High capture rate, leading capture rates by far in frontline, which is really, really critical, which gives you a sense the competitor is coming in and capturing in the second line. And then overall, we see a very substantial, overall IL-23 category expansion.
So when we look at all of those dynamics, our compete level is extremely high. And we're very, very comfortable with the momentum that we're gonna continue to see with SKYRIZI even before we get to RINVOQ coming in the later line. So that gives you some sense overall on IBD. I'll let maybe Rob address the second question.
Robert Michael: Yeah. So, Chris, this is Rob. Thanks for your question. Look. I see numerous sources of upside across the enterprise. I'll start with your question on SKYRIZI and RINVOQ. Obviously, the combined guidance for this year is already $500 million higher than our 2027 estimate, and we do expect both SKYRIZI and RINVOQ to grow robustly into the 2030s. And clearly, as we look at models, you know, that longer-term growth is not reflected. And so we do think on a longer-term basis, there's clearly more upside to SKYRIZI and RINVOQ. And then when you consider, you know, things like the market growth projections, we'll gain share, along with the next wave of RINVOQ indications.
You know, we have a lot of confidence in the long-term potential for those two assets. But beyond immunology, when you look at AbbVie, I think what's underappreciated is both I'd say, neuroscience and oncology in particular. I'd say neuroscience clearly overperforming. We delivered nearly 20% growth last year. We expect to deliver mid-teens growth this year. It'll put us in the number one position in the industry. I mean, Violet has already will already achieve our peak sales guidance this year. We had given long-term guidance of greater than a billion dollars peak. We're guiding to a billion dollars. We think our Parkinson's franchise, including BioLeb, Duopa, and Tivapadon can achieve peak sales in excess of $5 billion.
That's not reflected in treatment models. And given the ramp of our oral CGRPs, we believe our migraine franchise will also exceed $5 billion in peak sales. Recall, we gave peak sales estimates of greater than $3 billion based on this year's guidance, we're almost there. And so, clearly, the street is not modeling that type of upside for our migraine business. In psychiatry, we have several next-generation assets with 962, bradisilacin as Rupal highlighted, and emriclidine, which we're clearly studying the dose. That can help replace the $5 billion peak of Vraylar at its LOE in 2030. So we're in a very strong position to lead in neuroscience for the long term with three $5 billion plus franchises.
And I haven't even mentioned essential tremor or other therapeutic toxin indications, or the opportunity in Alzheimer's. And so, you know, we have, I'd say, a profound opportunity to lead in neuroscience for the long term, and that's clearly not reflected in street models. And then when I look at oncology, we have a very compelling pipeline that doesn't get enough attention. For example, our ADC tmAbA has shown promising data in CRC, lung, gastroesophageal, and pancreatic cancers. In CRC alone, tmAbA has the potential to be a multibillion-dollar opportunity, not to mention the other solid tumors that it could potentially treat. And we also have exciting opportunities in oncology, such as etentamig and the follow-on trispecifics in multiple myeloma.
Seven zero six in small cell lung cancer, and nine six nine in prostate cancer. So we have many opportunities to deliver upside to street long-term estimates. And with no significant LOEs until the next decade, we have plenty of capacity to invest in both internal and external innovation to drive very strong long-term growth.
Elizabeth Shea: Thank you, Chris. Operator, next question, please.
Operator: Next question is from Terence Flynn with Morgan Stanley. Your line is open.
Terence Flynn: Great. Thanks for taking the questions. Maybe two for me. Rob, appreciate your just your recent comments on looking at external innovation. Maybe you could give us an update on your BD lens, kind of the size and risk profile of potential deals you might consider. I know you did more of the early-stage deals as you walked through the beginning of the call, but how are you thinking about the opportunities on the forward here? And then maybe for Rupal, just wondering if you can frame expectations for the upcoming RINVOQ and Ludi Phase III HS data in terms of what you'd like to see from a target profile perspective? Thank you.
Robert Michael: Terence. It's Rob. So I'll take your first question here. You're right. If you look at the last two years, we've invested over $8 billion in external innovation that has added significant depth to our pipeline, with more than 30 deals. And again, these are opportunities that can drive growth in the next decade and beyond. To recap, I mean, in immunology, you know, we've added new mechanisms such as TL1A and TREM1 that can play a key role in our combination strategy.
We've added oral peptides capabilities from Nimble, the in vivo CAR T platform from Capstan, neuroscience, again, our next-generation assets in psychiatry, 932, bradycilsin, and americlidine have all come through BD, and we acquired a very compelling brain cell platform from Aliata that gives us an, I'd say, a very compelling opportunity in Alzheimer's. In oncology, we've added trispecifics and multiple myeloma that could follow etentamig. The in vivo CAR T platform from Umoja, as well as a PD-one VEGF antibody, which I highlighted in my remarks, which will complement our ADC portfolio. And I should also mention the siRNA platform from an ADX can really generate opportunities across all three of those therapeutic areas.
I mean, we're clearly focused on early-stage opportunities, so that we have solid growth drivers in the middle part of the next decade given how sizable we expect SKYRIZI and RINVOQ to be, and that's also why we utilize BD to enter into another growth area in obesity, which we will build upon as we identify other differentiated assets. We're clearly taking a close look at what's available out there, and to the extent we see something that we feel is differentiated, we'll pursue it. And I would say to the extent we see a differentiated asset in any of our core areas, whether early or late stage.
I think sometimes there's a misconception that we're only interested in early stage. We were willing to invest in late-stage assets. We certainly have the financial wherewithal. Strategically for the company, it's really about positioning the pipeline to deliver, you know, that growth in the next decade because we have clear line of sight to grow drivers for this decade. But, again, given our strong growth outlook and no LOEs this decade, we have plenty of firepower to pursue both early and late-stage opportunities. We're not limited to early stage, and we're focused on our core areas, immunology, neuroscience, oncology, and building out obesity.
Roopal Thakkar: Terrence, it's Rupal. I'll talk about HS expectations. So first of all, with RINVOQ, we're excited about this particular study and indication, especially as we look across previous indications. So for example, if you look at Crohn's disease and recently alopecia areata, RINVOQ really overperforms relative to any other JAK inhibitor in the class, along with any other biologic, if we were to take a look there. And that's why this study is going to be very important to build on the data that we've generated so far with RINVOQ. Now, I will say this will be in a treatment failure population because that's where we believe the JAK inhibitor class will be used in HS.
And the dermatologist will already have familiarity with it when they've already used it for atopic dermatitis and soon alopecia areata and vitiligo. So maybe the efficacy won't be as sky-high as we would see in a naive population. But we think it can be very meaningful because patients tend to cycle off of these assets as they become available. Now with lutekizumab, that one is a different mechanism. It's IL-one beta, beta in particular, it's very highly expressed in tissues of patients with hidradenitis suppurativa, and that one will be studied in a naive population and an experienced population. And so far in phase two, we've seen amongst the highest efficacy been reported.
So, hopefully in phase three, we'll see something similar. But you can also follow the positioning of these two future medicines in this space similar to what Jeff was describing previously in IBD. We'll have a lead asset in the naive setting. This would be lutekizumab. Has also shown very strong safety profile. High efficacy in phase two, and then one for those patients that are not finding relief with current biologics or even LUTI. So our sales teams and medical teams will have both of these to talk about in a similar concept that we have now demonstrated with IBD, quite successfully.
Elizabeth Shea: Thanks, Terrence. Operator, next question, please.
Operator: Next question is from Asad Haider with Goldman Sachs. Your line is open.
Asad Haider: Great. Thanks. Maybe first for Rupal, you talked about this a little bit already, but maybe if you could expand upon how you see the oncology portfolio evolving from here. With respect to novel combos, you've got this new externally sourced PD-one, better bispecific that you just brought in. Alongside your existing ADC asset. Do you see the portfolio as appropriately positioned now from that perspective? And are there other gaps that you see with respect to where the science is evolving? And then if I could just also throw one in for Scott on the aesthetics franchise, that's been in a protracted downturn based on macro headwinds.
I know you've talked about efforts to revitalize growth looking at Treneborn e approval. Later this year as a potential catalyst. Are you able to provide any quantitative framing on what you expect to see post-approval and launch just recognizing that there's some investor debate about the commercial opportunity for that program. Thank you.
Roopal Thakkar: Hey. It's Rupal. I'll start with oncology. You heard us talk about tmAbA in 706 as examples, and tmAbA multiple tumor types we get rapid efficacy which is very important and the strategy being maintaining that efficacy like a chemotherapy or better but having a better tolerability profile. For example, comparison to conventional chemo, we don't see the high rates of stomatitis, diarrhea, hair loss, which in fact you still see with certain ADCs, but we don't see that profile with our construct, with our linker technology. And our particular topo warhead, whether that's against cMAT or CESS6, for example. So that's a starting point.
And then the combinations become very important to help build on the durability of these assets and utilization over the long term so the patient is able to benefit maximally. And we believe that PD-one VEGF is a terrific combo partner. I mentioned colorectal and lung thus far. But as I stated, we're gonna see tmAbA readout in head and neck and ovarian. And that could be also potential areas of combination. The other key component of our oncology strategy is also having the ability to have a biomarker approach where physicians, patients are always seeking an individualized care regimen.
And we have seen examples particularly in GEA, I would say, and other tumor types that when you have slightly increased expression profiles you see higher efficacy. Though that sets up an ability to differentiate our portfolio over the long term. Now if there's examples where we don't need a biomarker approach, then we won't take it. So 706 is a good example in small cell lung cancer. And you asked maybe what's missing. We think a T cell engager could be a very nice combination with 706, and we have brought one in-house. The other internal development programs and access we already have that we're working on that hopefully will get to the clinic soon is in KRAS.
We are interested in lung, colorectal, pancreatic, strong data in pancreatic with tmAbA already, and we feel in the future having a selective KRAS hopefully, avoids NNH RAS, would allow for optimal combinations. So I would say very excited on the solid front. And just to briefly touch on, Rob mentioned, 969, we haven't talked much about that today. However, we're trying to get that data to ask so I would look for that. That is taking our bispecific technology similar construct than how we built lutekizumab against IL-one alpha beta. But in prostate cancer, this would be against PSMA and STeEP, and then we take the WARHEAD and linker technology from tmAbA and add that to 969.
So the team is excited about the potential in prostate cancer, which is a very large tumor type and I would say with still substantial unmet need, and we described the heme side where we have next generational BCMA, CD38, and GPCR 5d, assets moving rapidly into the clinic.
Jeffrey Stewart: And then maybe it's Jeff. I'll address your training bot in the Botox question. I think what's important as we look into 2026, largely what we see is that the sales impact of the Trini bot will largely accrue really to Botox, and I'll walk through that. But given the timing of the launch and the fact that right now we have plans to train 12,000 core injectors, it's really gonna not really appear until towards the end of the year, but it's gonna gate heavily into 'twenty seven. So I'll give you some sense of how the dynamics will work.
We believe when we look at the patient funnel, that, at peak, we could potentially up to double the inflow of patients that would basically start to move into the toxin market. Because they're still, you know, we look in the US, 55 million considerors that just haven't made that leap yet. So the first dynamic is the stimulation of the market that starts to start to gate in at the '26 and certainly we believe, heavily into '27 and '28. The second thing that we see is that since it is a short-duration toxin, it only lasts for two and a half to three weeks.
The real commercial impact goes to your conversion rate our key performance indicator of how fast we convert to full-strength Botox. And the way that we think about that metric is right now we have very high leading share in the US in the low 60s percent. We would anticipate that once patients start on Trenebot, as they start to gate in over this time period, that we have a much higher conversion rate than our existing share. So it starts to build share as well. And so net-net, we were very excited about this innovation.
We think it's gonna operate to sort of increase inflows substantially over our plan, again, more in the '27 and beyond standpoint as we get training ramped up, and also accrue to Botox share. So that's how we're looking at that market development over time.
Elizabeth Shea: Thanks, Asad. Operator, next question, please.
Operator: Next question comes from Vamil Divan with Guggenheim Securities. Your line is open.
Vamil Divan: Great. Thanks for taking the question. Maybe one, do have, actually, still on the Botox topic. And then one other one. On Botox, we were sort of surprised to see that one selected for the Medicare price reductions in 2028. I'm wondering if this is a surprise to you as well or you're sort of expecting that. And then what that might mean for pricing on the cosmetic side? Because I think it's always been tied to therapeutic and cosmetic pricing. So if there's reductions from Medicare on the therapeutic side, what you have to sort of carry that over to cosmetic care? Do maybe have more flexibility in some way? In the future.
And then my second question is back on the immunology. Franchise. And I caught them away. You said around 1Q pricing dynamic. But maybe you can just share your thinking around pricing overall on that. Market. First, I was in RINVOQ. First day this year and maybe over the next couple of years. Just how things evolve from a pricing perspective. Thank you.
Robert Michael: Thanks, Vamil. It's Rob. Jeff and I will tag team your first question here. So as it relates to Botox being selected for Medicare negotiation, we're obviously disappointed that it was selected given that it's a plasma-derived product and should have been excluded. That said, we did plan conservatively that it could be selected based on CMS spend, so its selection does not impact our long-term growth guidance at all.
Jeffrey Stewart: Yeah. And, also, in terms of the pricing separation, we're comfortable with how we understand that effectuation may ultimately take place if and when it does happen in 2028. Certainly, we did see that when the announcement was made, there were comments around Botox Cosmetic, but that's just more of a formulaic dynamic with the way the government looks at NDCs, but it's quite clear that you know, there's a cash pay component. So we don't see a large or meaningful interaction between the two even if we do see the negotiation take place in twenty-eight.
Scott Reents: Sure. And this is Scott. I'll address your question on pricing for SKYRIZI and RINVOQ. So we've talked about it, and we continue to expect low single-digit pricing headwinds for both of those products, both in '26 and over the next few years as well. That's what we've seen. I would tell you '25 was unique. We had some pricing tailwinds in '25. And so in the end, for SKYRIZI, we were roughly flat for pricing on the year for SKYRIZI. Had some positive price in the first half of the year, some and it was negative price in the back half of the year. And RINVOQ was slightly down on a year-over-year basis for pricing in '25 as well.
Pricing favorability in the first half and pricing unfavorability in the second half, netting to slightly down. That does come into play when we look at, for instance, the first quarter of RINVOQ. You'll see that pricing headwind, frankly, high single-digit as an unfavorable comparison that RINVOQ is facing on a prior year basis. So those dynamics will be played, but you're going to see low single-digit pricing in '26 for both products and then, you know, going forward as well as our anticipation.
Elizabeth Shea: Thanks, Vamil. Operator, next question, please.
Operator: Next question is from Steve Scala with TD Cowen. Your line is open.
Steve Scala: Thank you so much. It is clear that you are confident in SKYRIZI in IBD, but the competition is growing very rapidly. And it looks like it's inevitable. It will make an important impact on SKYRIZI. So what can be done to neutralize these gains at this juncture? And secondly, in the drug pricing deal AbbVie signed with President Trump, the release noted exemption from tariffs and future pricing mandate. Can you elaborate on what exemption from future pricing mandates constitutes beyond avoidance of demonstration projects? And how important is avoidance of demonstration projects? Thank you.
Jeffrey Stewart: Yeah. Hi, Steve. It's Jeff. Just maybe a few comments. You know, I've outlined how stable our capture rates are. Look, it is a competitive market. There have been changes in terms of frontline and later lines, but we're very, very confident that we're going to see very significant growth in leadership with SKYRIZI over IBD as well as the RINVOQ dynamic we discussed. Now what are some things that we can think about and are thinking about in terms of continuing the momentum and even increasing our momentum. First, you know, if this is not a zero-sum game with the two IL-23s. There's a lot of other products in the marketplace.
And I think that we've highlighted before, we will shortly see a readout over a head-to-head study with Entyvio. Entyvio is the leading agent or close to it with SKYRIZI in UC and it does pretty well in Crohn's as well. So with the head-to-head data for SKYRIZI versus Entyvio, we see a significant opportunity to continue the momentum beyond just the IL-23 growth and the competition that we've been talking about. The other dynamic that we see there is a it's a modest, I would say, market value driver. It gets a lot of play over this idea of a sub q induction versus an IV induction.
And as Rupal highlighted in his prepared remarks, we will close that gap. We believe, sometime in early twenty-seven. Based on the readout that we're anticipating. So we have, you know, many, many strategies that we continue to pursue to make sure that we can maintain and sustain our SKYRIZI leadership over time.
Robert Michael: Hey, Steve. This is Rob. You know, we're pleased that we were able to reach an agreement with the Trump administration that, again, balances affordability and access and protects the US innovation ecosystem going forward. And so, we're pleased where that's landed. As you noted, similar to many of our peers who did, also, execute agreements, we are exempt during the term from tariffs, as well as the pricing mandates inclusive of demonstration projects. So your understanding is correct.
Elizabeth Shea: Thank you, Steve. Operator? Next question, please.
Operator: Next question is from Mohit Bansal with Wells Fargo. Your line is open.
Mohit Bansal: Great. Thank you very much for taking my question. Maybe a question on the migraine primary care expansion here. So in Pfizer yesterday, talked about that they are generating about 83% share in the new prescribers for in the migraine market. I'm assuming this is all primary care, but again, would you talk a little bit about how your expansion strategy into primary care going? And then do you are you seeing any increased competition there from the competition in the migraine market? Thank you.
Jeffrey Stewart: Yes. Thanks for the question. We're as Rob mentioned in one of his responses, we are extremely pleased with our migraine business. I mean, certainly, we have a very large Botox business. It's the only toxin approved in chronic migraine. And just to be very, very clear, we have the absolute leading brand with UBRELVY in acute migraine. Okay? And that lead is expanding. We also have recently become the number one branded drug in the episodic oral CGRP for prevention with QLIPTA. So we have an extremely strong position. It's very difficult for us to triangulate against what the competitor said.
But you can just look at our reported sales when you add up our total oral CGRP sales, which is also rapidly globalizing. So we see, if anything, that we're going to continue to stretch our lead in that area. Now we also have considerable primary care presence right now with both Ubrellvy and we call on essentially over 70 or 80,000 physicians, most of which are primary care physicians. We also cover headache specialists neurologists, of course. So we have very significant reach and we have also a very significant lead in this category.
Robert Michael: And this is Rob. I'll just add. I mean, as we saw the comment this well, it's hard for us to reconcile when you just compare the revenue in 2025 for Qlipta and Yubrelevy. Combined is almost $1 billion higher than the competitor. So it's difficult for us to reconcile the numbers that were being quoted. When I look at the performance of the oral migraine franchise and just the continuous share gains, we're talking about, you know, over a point every year and now delivering, you know, almost $3 billion this year, which was, again, the peak that we had previously communicated. And, obviously, both brands have long runway.
And so as I mentioned before, as we look at these brands, we would expect them to exceed $5 billion now. So just tremendous momentum. The profile of both drugs is very powerful. And the commercial execution has been very strong.
Elizabeth Shea: Thank you, Mohit. Operator, next question please.
Operator: Next question is from David Amsellem with Piper Sandler. Your line is open.
David Amsellem: Hey, thanks. So on RINVOQ and Vitiligo, can you talk about the sizing of that opportunity given the dirt that's systemic options? And also, do you perceive a competitive threat from IL-fifteen directed therapies in vitiligo down the road? That's number one. And then secondly, as you talk about potential replacement for Vraylar following its LOE, does that also contemplate a long-acting form of cariprazine as one of those replacements? Thanks.
Jeffrey Stewart: Yeah. Hi. It's Jeff. I'll take the vitiligo question. So, yeah, we've highlighted that if you look at our next generation of our next wave of RINVOQ approvals, that we anticipate roughly $2 billion or more in peak year sales. And those are going to start to gate out here relatively soon. We're right on track with GCA, which is moving quite well. It's the smallest of the bunch. It's difficult to say. When we look at vitiligo, I mean, we've sized that opportunity, you know, roughly just above half a billion at peak? But, again, we could surprise ourselves there. I mean, the data looks quite strong. And to your point, it is the only systemic agent.
And so, ultimately, where we end up in terms of that peak year sales will also depend on the labeling that we get as we go through the process. Certainly, we're reviewing quite a bit of disease state awareness that we'll start to gate in with AbbVie spending. In the middle part of the year where we're gonna basically highlight the fact that there is no systemic treatment for this disease that has tremendous psychosocial impact and is probably still underestimated in terms of what might happen. But, again, we're still really roughly in that $2 billion plus range for all of those new indications and excited to bring vitiligo to the market.
Roopal Thakkar: And David, it's Rupal. Maybe on the competitive side, we'll have to see this over time. I mean, there's growing familiarity with RINVOQ now in dermatology. With atopic dermatitis soon for HS, alopecia areata, and the efficacy is very strong and what we're also observing is in alopecia areata and vitiligo seems to continue to increase over time. And the tolerability with our simple oral is also appreciated by a physician and patient. So if that were to enter again, I think we still have the opportunity to compete based on the high efficacy that we've seen across other indications.
David Amsellem: David. Oh, sorry. Sorry. We've got a follow-up on Vraylar. Sorry.
Roopal Thakkar: Yeah. And maybe on the on the Vraylar LAI. Yes. We do have some partnerships in place, and then we're assessing. I would just say, not just Vraylar, but other assets in terms of long-acting injectables. We've seen good tolerability and high efficacy with Vraylar. So that one could be quite amenable to this type of strategy.
Elizabeth Shea: Thanks, David. Operator, next question, please.
Operator: Next question is from Luisa Hector with Berenberg. Your line is now open.
Luisa Hector: Hi there. Thank you. I have a couple. On aesthetics, just to check, are there any regions where you are losing share in toxins or fillers? And is this franchise that's profitable? Than when you acquired it? And maybe to touch on a b I don't know if you can just remind us what the profile is you're looking for in your Amylin and how soon you might pivot into phase three. Could you launch on weight loss only without the longer CVOT trials? Thank you.
Jeffrey Stewart: Yeah. Hi, Luisa. I couldn't understand the full question, but there are some areas where we have had some share loss. I'd say particularly in Brazil, Brazil has been the one area where we've seen some declines in share, particularly in the filler category. And I'm glad you asked the question because we do have a geographic mix issue that has come in 2025 where Brazil and Latin America tends to grow, and we've lost a little bit of share. Whereas we have much more stable or growing share in China and Asia. So hopefully, answers your question.
Robert Michael: And maybe to put a little bit of perspective, just keep in mind that the US and China is a vast majority of the aesthetics business for us. When, you know, Jeff talks about a market like Brazil, you know, you're talking about less than $100 million. So just to put in perspective that to the extent we have lost some share there, it's a very small market for us.
Roopal Thakkar: And then on obesity, it's Rupal. You know, the key for us there is gonna be that tolerability profile along with weight, I think as the incretins readout within a few percentage points of each other, whether it's weekly or monthly, we still feel that there's gonna be a substantial number of patients that are gonna cycle off of those for a variety of reasons, including tolerability. So with the two phase ones that are underway now, us looking for dosing regimens and potentially even going out to monthly is gonna be the key for us as we go forward into phase two and phase three.
With regard to being able to pull in phase three, certainly that would be regulatory discussions that we would have, especially if we see strong safety and efficacy profiles as the data emerge.
Elizabeth Shea: Thanks, Luisa. Operator, next question, please.
Operator: Next question is from Michael Yee with UBS. Your line is open. And, Michael, if you're there, please check your mute button.
Michael Yee: Can you hear me okay? Great. Just in terms of immunology. Yep. In terms of the Crohn's disease immunology platform program that's ongoing, I think I've seen on ct.gov, and you pointed out is critically important. Can you just tell me a little bit about what you're to get from that study? Is it going to raise the bar in terms of efficacy and that is obviously, is the key component of this to extend your leadership. Thank you.
Roopal Thakkar: Yeah. Hi. It's Rupal. So, yes, the increasing efficacy would be important the degree of which will be determined by the types of patients. So if we are studying naive patients, which there could be less and less as we've seen SKYRIZI just have tremendous penetration in IBD in the frontline than our consideration is what can come after. So a key component of these IBD platform studies are also to study patients who have already received SKYRIZI. So there could be a slightly different efficacy outcome there if you're looking at second and third lines.
These are very important lines in IBD because they continue to expand as patients roll off of anti-TNFs and we've actually seen less and less clinicians turning to anti-TNFs. So this is where 23s are becoming very important as Jeff has highlighted, in particular SKYRIZI. And when we look at combinations with SKYRIZI, can we treat those patients as well. The tolerability also will be very important. We're doing our best to avoid boxed warnings if at all possible, which would exist if we combine with an anti-TNF. Which is not our strategy, because there's less and less utilization. We do have an alpha four beta seven. We've talked about ludi.
We also have TL1A, which can also be a good combination. The other core component of this strategy is also in parallel as these data read out. Is to look at our ability to coformulate and deliver these together in a patient-friendly way. So many things coming together, and we're excited to hopefully share some data this year.
Elizabeth Shea: Thanks, Michael. Operator, we have time for one final question.
Operator: The final question is from Evan Singelman with BMO Capital Markets. Your line is open.
Malcolm Hoffman: Hi. This is Malcolm Hoffman on for Evan. Thanks for taking our question. So I wanted to touch on 932, which I think has been addressed or at least mentioned a couple of times throughout the call. But I know you have the Phase two readout later this year in bipolar. As a follow-on to VRAYLAR, can you maybe give us some framing on how you're thinking could compare to Vraylar given the heavier targeting of D3 versus D2? And then just a second follow-up there. If you're looking to pursue drug and anxiety as well, is there any expectation to expand into areas like addiction again, given the heavier D3 reliance here? Thank you.
Roopal Thakkar: Thanks. It's Rupal. I'll take that. So, yes, later this year, we'll see the data 932. Currently, I'll talk about generalized anxiety disorder. We do not have that approved for Vraylar, though we have seen effect in patients who have some anxiety lowering of those scores, and that's why I think we see such strong uptake of Vraylar and why it was important to study a next generational version. Hopefully, with less D2, we anticipate potentially less movement disorder. So that's one thing that we would be looking for is that safety and tolerability profile. While maintaining efficacy. I think that'll be important. We'll also see a breakdown between bipolar one and bipolar two.
We have observed that Vraylar has worked better on the bipolar one side. That could be a potential outcome, but that's data that we're gonna look at. Also, that'll be very important. And in terms of other indications, that could be, what you mentioned, could be something else that we would look at. And as we step back and consider all of psychiatry, we'll have two studies in phase two with a kappa opioid receptor antagonist which we believe has strong potency. I mentioned bretacilacin, in depression, but you could imagine there could be indication expansion for that one as well.
And as we make good progress with emeraclidine, and those doses, being able to go higher again, having potential there in psychosis of neurodegeneration as well as schizophrenia that we've mentioned. So along with 932, there's a whole portfolio there, and I'll mention continue to partner with Gideon Richter and there's even a more D3 leaning asset that is within preclinical tox that could also see a first in human within the next year or eighteen months.
Elizabeth Shea: Thanks, everyone. 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. Again, thank you for joining us.
Operator: This concludes today's call. Thank you for your participation. You may disconnect at this time.
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