Q2 2025 Earnings Call Transcript

Good morning, and thank you for standing by. Welcome to AbbVie's Second Quarter 2025 Earnings Conference Call. [Operator Instructions] Today's call is also being recorded. If you have any objections, you may disconnect at this time. I would now like to introduce Ms. Liz Shea, Senior Vice President, Investor Relations. Ma'am, you may begin.

Thank you. 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.

Thank you, Liz. Good morning, everyone, and thank you for joining us. AbbVie delivered another outstanding quarter with results exceeding our expectations. We are making excellent progress advancing our pipeline and adding more depth through strategic transactions that support our long-term growth.

Turning to our second quarter performance. We delivered adjusted earnings per share of $2.97, which is $0.11 above our guidance midpoint. Total net revenues were $15.4 billion, more than $400 million ahead of our expectations. This overachievement includes sales growth of 22% from our ex-HUMIRA platform with continued robust performance from Skyrizi and Rinvoq, which are now on pace to deliver more than $25 billion in combined sales this year, well above our initial expectations.

We also delivered strong double-digit growth from neuroscience, driven by Vraylar, Vyalev and our leading migraine portfolio. Based on our momentum through the first half of the year, we are raising guidance for the second time. We now expect full year revenue of $60.5 billion, an increase of $800 million. We have now raised our revenue guidance by $1.5 billion since the start of the year.

We are also raising our full year adjusted earnings per share guidance by $0.21 and now expect adjusted EPS between $11.88 and $12.08. In addition to our strong financial results, we are making great progress with our R&D pipeline across all stages of development. Notable highlights from our late-stage programs include the recent approvals of EMRELIS for non-squamous non-small cell lung cancer and Rinvoq for GCA. The regulatory submission of TrenibotE, a first-in-class short-acting toxin in aesthetics as well as highly differentiated Phase III results in alopecia areata, a potential tenth indication for Rinvoq in the U.S.

We are also focused on augmenting our pipeline with therapies and platform technologies that have the potential to elevate the standard of care for patients. These include promising early-stage programs that have the potential to drive growth for AbbVie in the next decade. We have executed more than 30 business development transactions since the beginning of last year. Our recent activity includes closing the agreement with Gubra for a long-acting amylin analog in the treatment of obesity as well as announcing our planned acquisition of Capstan Therapeutics, giving us an in vivo CAR-T platform that can further strengthen our immunology pipeline.

We also in-licensed ISB-2001, a novel trispecific antibody for multiple myeloma, and we announced the collaboration with ADARx to develop next-generation siRNA therapies across multiple disease areas, including immunology, neuroscience and oncology. In summary, I'm very pleased with the performance of our business and the progress we are making against our long-term strategy. AbbVie's outlook is strong, and we are well positioned to deliver on our commitments in 2025 and beyond. With that, I'll turn the call over to Jeff for additional comments on our commercial highlights.

Jeff?

Thank you, Rob. I'll start with the quarterly results for immunology, which delivered total revenues of more than $7.6 billion. Skyrizi continues to demonstrate impressive growth. Global sales were $4.4 billion, up 61.8% on an operational basis.

We continue to capture robust in-play patient share in psoriatic disease. In the U.S., this includes clear leadership in psoriasis across all lines of therapy versus both biologics and oral agents as well as continued strong performance in the PSA derm setting with frontline in-play share leadership more than double the next closest biologic oral therapy. Globally, Skyrizi continues to grow and achieve total psoriatic disease market leadership in numerous major markets around the world. I'm also very pleased with Skyrizi's performance in IBD, where we are on track to double our sales this year.

In the U.S., we continue to capture more than 1/3 of new or switching patients in Crohn's disease and nearly 20% of new or switching patients in ulcerative colitis. As we look ahead, we feel very confident in Skyrizi's profile, including compelling efficacy, safety and dosing and our very robust head-to-head program, where we have demonstrated superiority and clear differentiation against multiple novel therapies sets a high bar for comparison. So as we do compare our current dynamic share to total prescription share, it's clear there is still a substantial opportunity for continued total share gain across all of Skyrizi's indications over time, especially in ulcerative colitis and Crohn's disease, which are still earlier in their launch trajectory.

Turning now to Rinvoq, which is also demonstrating outstanding growth. Global sales were $2 billion, up 41.2% on an operational basis as we continue to see nice momentum across all of Rinvoq's indications. Uptake in IBD continues to be very strong. In the U.S., Rinvoq's in-play patient share across all lines of therapy for both ulcerative colitis and Crohn's disease is second only to Skyrizi among branded medicines.

So as a portfolio, Rinvoq and Skyrizi together are capturing 1 out of every 2 in-play Crohn's disease patients and 1 out of every 3 in-play UC patients in the U.S., a very strong combined leadership position in gastroenterology for AbbVie. I'd also highlight that we are making excellent progress with Rinvoq's global launch in giant cell arteritis, our sixth indication in rheumatology. Initial prescription trends as well as feedback from rheumatologists has been positive, with access in the U.S. expected to ramp quickly over the rest of the year. Finally, we announced impressive Phase III results in alopecia areata, a chronic autoimmune disease leading to unpredictable hair loss with nearly 2 million diagnosed patients globally. alopecia areata as well as the next wave of diseases, including vitiligo, HS and lupus, would expand Rinvoq's treatment in both dermatology and rheumatology, areas where we already have very strong call points with Rinvoq's core indications.

Turning now to HUMIRA, which delivered global sales of more than $1.1 billion, down 58.2% on an operational basis, reflecting biosimilar competition. We anticipate HUMIRA access in the U.S. will continue to decrease throughout the second half of this year as more plans select exclusionary formularies for existing patients. Moving to oncology, which delivered total revenues of nearly $1.7 billion. IMBRUVICA global sales were $754 million, down 9.5%, reflecting continued competitive dynamics in CLL, partially offset by higher persistency rates for existing patients.

Venclexta global revenues were $691 million, up 8.3% on an operational basis. This reflects strong demand in CLL with combination use of Venclexta plus BTK inhibitors emerging as a preferred fixed duration treatment. We are also seeing nice momentum from ELAHERE and EPKINLY with both delivering double-digit revenue growth. And we are early in the U.S. launch of EMRELIS, our newest ADC for previously treated non-squamous non-small cell lung cancer patients.

This commercialization will help to establish c-MET expression as a valid biomarker in non-small cell lung cancer and also build AbbVie's presence more broadly in solid tumors, where we have several promising next-generation ADCs in development, including Temab-A, which shares the same c-MET target. Turning now to aesthetics, which delivered global sales of nearly $1.3 billion, down 8% on an operational basis. BOTOX Cosmetic global revenues were $692 million and JUVÉDERM global sales were $260 million, with growth rates for both products down on an operational basis. Consistent with the past few quarters, economic challenges and lower overall consumer sentiment have impacted the aesthetics market, which continues to perform below historical levels.

As noted on the first quarter call, we moderated our assumptions for near-term category growth globally, which is tracking largely in line with our expectations. From a competitive perspective, our facial injectable portfolio remains the clear leader with strong market shares globally. Our progress with the Alle loyalty program is going well, and we have robust plans underway to support patient activation. This includes a new BOTOX consumer campaign in the U.S. with ramping second half investment. continued injector training globally and bringing new products to market like TrenibotE, our fast-acting short-duration toxin with commercialization expected next year.

So as economic conditions improve from current levels, we remain very well positioned for growth over the long term in the aesthetics category. Moving now to neuroscience, our second largest therapeutic area, where we continue to demonstrate robust growth. Total revenues were approximately $2.7 billion, up 24% on an operational basis. This exceptional performance is driven by continued double-digit operational growth of Vraylar with global sales of $900 million, up 16.3% BOTOX Therapeutic with global revenues of $928 million, up 14.2% Ubrelvy with global sales of $338 million, up 47.2% and QULIPTA with global revenues of $267 million, up 76.9%.

Importantly, we recently announced positive results from the head-to-head TEMPLE study comparing QULIPTA to topiramate for migraine prevention. TEMPLE demonstrated that QULIPTA had fewer treatment discontinuations attributed to adverse events as well as a significant reduction in migraine days versus topiramate. Given the high use of topiramate as a frontline treatment for migraine prevention, we anticipate these strong results will support earlier adoption of QULIPTA. Moving to Parkinson's disease.

I'm very pleased with the performance of VYALEV, where the global launch is off to an excellent start. Total sales were $98 million, up 56% on a sequential basis. Feedback from movement disorder specialists has been overwhelmingly positive with uptake across the international markets exceeding our expectations. Looking forward, we believe our emerging Parkinson's disease portfolio with VYALEV, Duodopa and tavapadon forthcoming has the collective potential to be a multibillion-dollar opportunity over the long term.

So overall, I'm very pleased with the execution and continued strong performance across our commercial portfolio. And with that, I'll turn the call over to Roopal for comments on our R&D highlights. Roopal?

Thank you, Jeff. Starting with immunology, where we continue to make meaningful progress advancing our pipeline with several regulatory and clinical milestones since the last earnings call. FDA approval was granted for Rinvoq in GCA, representing our sixth rheumatology indication. Additionally, top line data from the first Phase III Rinvoq alopecia areata trial were just announced.

In the study, Rinvoq met the primary and key secondary endpoints, demonstrating a statistically significant improvement in hair regrowth across both Rinvoq doses compared to placebo. Baseline scalp coverage prior to treatment was approximately 16%. In the Rinvoq 30-milligram group, 54% of patients reached 80% or more scalp hair coverage and 47% reached 90% or more coverage at 24 weeks. A robust effect was also demonstrated with Rinvoq 15 milligrams.

These are truly transformative results and compare very favorably to the efficacy shown in pivotal trials for other JAK inhibitors. The placebo-adjusted SALT 20 and 10 scores for Rinvoq 30 milligrams were approximately 20 percentage points above the rates for the highest approved doses of other JAK inhibitors. For the Rinvoq 15-milligram group, rates were approximately 10 points above. We are very pleased with these results, which certainly surpassed our expectations.

Results from a second Phase III alopecia areata study are anticipated in the third quarter, followed by regulatory submission starting later this year. The vitiligo program for Rinvoq is also nearing completion with top line results from Phase III studies expected later this year. External innovation has supported expansion of our growing immunology pipeline. We recently announced plans to acquire Capstan.

Their novel platform allows for in vivo programming of cells through mRNA delivery using targeted lipid nanoparticles. Capstan's lead asset currently in Phase I generates CD19-specific CD8-positive in vivo CAR T cells. The CAR T cells are designed to achieve rapid and deep B-cell depletion without the need for lymphoablating chemotherapy while also avoiding other challenges associated with conventional ex vivo CAR-Ts. This innovative approach has the potential to become a transformative new treatment modality to reset the immune system and provide deep, durable drug-free remission for patients with autoimmune disease.

Capstan's technology is a strong strategic fit for our early immunology efforts, where we have a number of internal assets designed to reset the immune system via depletion of pathogenic cells with the goal of delivering functional cures. We plan to advance several assets that deplete B cells into the clinic, each with a different target or modality. These include 2 anti-CD19 monoclonal antibodies that activate cell-mediated cytotoxicity, one with and the other without a payload, etentamig, our BCMA CD3 bispecific T cell engager and ISB-2001, a BCMA CD38, CD3 trispecific T cell engager that is part of our recently announced agreement with IGI Therapeutics.

An interim analysis was recently completed on our monotherapy trial evaluating Lutikizumab in ulcerative colitis. Lutikizumab showed numerically higher efficacy for the primary endpoint of endoscopic improvement compared to HUMIRA, which was the control arm. However, the results were not sufficiently differentiated for us to pursue it as a monotherapy in this population. We believe there is still opportunity to drive incremental efficacy as a combination therapy in Crohn's disease, where Lutikizumab is being evaluated in combination with Skyrizi.

Lutikizumab is one of several assets being studied and results from our Crohn's combination platform study will begin to read out next year. Lutikizumab has the potential to drive efficacy across other autoimmune diseases. It has demonstrated strong efficacy in hidradenitis suppurativa, where Phase III is ongoing with data expected in 2027. Additional studies are underway evaluating monotherapy or combination approaches in psoriatic arthritis, atopic dermatitis and rheumatoid arthritis. Moving to oncology.

EMRELIS received accelerated approval from the FDA as a monotherapy in previously treated non-squamous non-small cell lung cancer with high c-Met expression. This is an important new treatment option for patients with this challenging disease. At the recent ASCO meeting, we presented encouraging data for several novel ADCs in our oncology pipeline, including preliminary data from a Phase I dose expansion study evaluating Temab-A, our next-generation c-Met ADC in patients with EGFR-mutated non-squamous non-small cell lung cancer. Temab-A demonstrated high and durable responses across c-MET expression levels with an objective response rate of 63% and median duration of response of 9.8 months.

Based on these results, we plan to initiate additional studies in both first and second line. Other highlights from the ASCO meeting included encouraging early-stage results for ABBV-706 in high-grade neuroendocrine tumors and results from a registration-enabling Phase II study evaluating PVEK in BPDCN, which will support a regulatory submission later this year. At the ESMO meeting this fall, we have several planned presentations for Temab-A, including results from a Phase II study in combination with bevacizumab in CRC as well as data from a proof-of-concept study in pancreatic cancer. We will also present updated data at the upcoming World Conference of Lung Cancer. from our ABBV-706 dose-ranging proof-of-concept study in small cell lung cancer.

In the area of hematologic oncology, we recently announced a license agreement with IGI Therapeutics to develop a novel trispecific T-cell engager for multiple myeloma and autoimmune diseases. This first-in-class T-cell engaging antibody targets BCMA and CD38 on myeloma cells and has the potential to deliver deep and durable responses, ultimately improving outcomes for patients. Despite advancements, the 5-year survival rate in multiple myeloma is still only about 60%. So unmet needs remain high.

Quality of life is also important. Patients currently receive triplet and quad therapy, which can be challenging from a safety and convenience standpoint. HCPs and patients will continue to seek next-generation therapies that can provide high efficacy, better safety and less complicated dosing regimens. We are extremely well positioned to address the unmet needs across all patient segments in multiple myeloma with 3 next-generation multi-specific T cell engagers, etentamig, ISB-2001 and SIM0500. These off-the-shelf therapies may be particularly important for community-based sites, where approximately 80% of patients receive care.

In the area of neuroscience, we announced positive top line results from the head-to-head Phase III TEMPLE trial comparing QULIPTA and topiramate for migraine prevention. The primary and all secondary endpoints were met in the study, demonstrating that patients treated with QULIPTA had fewer discontinuations due to adverse events and a greater reduction in migraine days compared to patients receiving topiramate. Over the 24-week treatment period, 12% of patients discontinued QULIPTA due to adverse events compared to 30% for topiramate. 64% of patients on QULIPTA achieved at least a 50% reduction in mean monthly migraine days compared to 39% of patients on topiramate.

These results add to the body of evidence supporting QULIPTA as a first-line treatment option for episodic and chronic migraine prevention. In the quarter, MAVYRET was approved for the treatment of acute HCV. With this label expansion, caregivers can now treat HCV patients immediately following diagnosis rather than waiting until progression to chronic disease. Earlier treatment, coupled with increased testing brings us closer to achieving the World Health Organization's goal of global HCV elimination by 2030. To summarize, we've made significant progress across all of our therapeutic areas in the first half of the year and continue to expand our pipeline through internal and external innovation.

We look forward to additional data readouts and regulatory milestones throughout the remainder of 2025. With that, I'll turn the call over to Scott.

Thank you, Roopal. Starting with our second quarter results, we reported adjusted earnings per share of $2.97, which is $0.11 above our guidance midpoint. These results include a $0.42 unfavorable impact from acquired IPR&D expense. Total net revenues were $15.4 billion, reflecting growth of 6.5% on an operational basis, excluding a modestly favorable impact from foreign exchange.

Adjusted gross margin was 84.4% of sales, adjusted R&D expense was 13.7% of sales and adjusted SG&A expense was 21% of sales. The adjusted operating margin ratio was 44.3% of sales, which includes a 5.3% unfavorable impact from acquired IPR&D expense. Net interest expense was $678 million. The adjusted tax rate was 16.2%.

Turning to our financial outlook. We are raising our full year adjusted earnings per share guidance to between $11.88 and $12.08. Please note that this guidance does not include an estimate for acquired IPR&D expense that may be incurred beyond the second quarter. We now expect total net revenues of approximately $60.5 billion, an increase of $800 million. This reflects a relatively neutral impact from foreign exchange on full year sales growth.

Our updated revenue forecast includes the following approximate assumptions for several of our key products and therapeutic areas. In Immunology, we now expect Skyrizi global revenues of $17.1 billion, an increase of $600 million, reflecting continued share gains in psoriasis and IBD and U.S. HUMIRA revenues of $3 billion, a decrease of $500 million, reflecting biosimilar competition. In neuroscience, we now expect global sales of $10.5 billion, an increase of $300 million.

This includes a $100 million increase for VYALEV, reflecting strong international uptake with the remaining $200 million increase split relatively evenly across Vraylar, BOTOX Therapeutic and the total oral CGRP portfolio. And in oncology, we now expect Imbruvica global revenues of $2.9 billion, an increase of $100 million, reflecting higher persistency rates for existing patients and Venclexta global sales of $2.8 billion, an increase of $100 million, reflecting continued strong demand in CLL. Moving to the P&L for 2025. We continue to forecast full year adjusted gross margin of approximately 84% of sales.

We now expect adjusted R&D expense of approximately $9 million and adjusted SG&A expense of approximately $13.5 billion. We also now anticipate an adjusted operating margin ratio of roughly 45% of sales, in line with our previous expectations after including the 1.8% unfavorable impact of acquired IPR&D expense incurred through the second quarter. Turning to the third quarter. We anticipate net revenues of approximately $15.5 billion.

This reflects an estimated 1% favorable impact from foreign exchange on sales growth. We expect adjusted earnings per share between $3.24 and $3.28. This guidance does not include acquired IPR&D expense that may be incurred in the quarter. In closing, AbbVie once again delivered outstanding top and bottom line performance with results well ahead of our expectations. I'm pleased with the momentum from our ex-Humira platform, including Skyrizi, Rinvoq and neuroscience, which further supports AbbVie's long-term outlook.

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

Thanks, Scott. We will now open the call for questions. [Operator Instructions] Operator, we'll take the first question, please.

First question comes from Mohit Bansal with Wells Fargo.

Congrats on all the progress. I have a question regarding the impact of STELARA biosimilar on Skyrizi and Rinvoq here, especially Skyrizi. So I mean, one end, it could be -- I mean it could be considered as a negative impact. But as you saw with HUMIRA biosimilar, people decided to not move change to biosimilar, but to a more efficacious drug like Skyrizi and Rinvoq.

How do you think about the impact of biosimilar considering these 2 dynamics here?

Yes. Thanks, Mohit. It's Jeff. And you're right that we did see certainly with the first exclusionary formulary that was CVS last year, we did see movement from Humira not all of it went to the biosimilars.

Some went to, as you mentioned, Skyrizi and Rinvoq. Now STELARA is still relatively early, and there are more interchangeable biosimilars. So -- and it's -- frankly, it was a much smaller drug because it's really just concentrated in GI. So it's difficult to sort of tease out exactly what movement we're seeing.

Certainly, we did see that some physicians as they think about a movement would be more willing to look at the higher-end products. But net-net, I think that fundamentally, the core -- the core momentum around Skyrizi and Rinvoq are simply related to just the outstanding data, the breadth of indications, our connections with physicians in terms of our value proposition. So I would say, if anything, it's a minor certainly contributor.

And this is Rob. I'll just add on. If you recall, we had the Sequence head-to-head trial, Skyrizi versus STELARA, and we did see significant share gains following the release of that head-to-head. And so when you think about Skyrizi's performance versus STELARA before the biosimilar, we saw a very notable share inflection.

And as Jeff mentioned, what we're seeing right now is just continued momentum from Skyrizi. I would not attribute that to be an impact from the biosimilar, but I should want to make clear that we did see very nice share uptake following the Sequence head-to-head trial.

Next question comes from Terence Flynn with Morgan Stanley.

Great. Maybe 2 for me. Obviously, another solid quarter here from Skyrizi. It's annualizing at about $18 billion now.

I know you have the 2027 guidance out there for over $20 billion. So just maybe help us think about that number and confidence there. And kind of if you could tie in Rinvoq as well, again, annualizing $8 billion, I think that guidance is for over $11 billion in 2027. And then I know you might not have a lot of details yet, but just any thoughts on the latest tariff announcement regarding the EU and how that might impact 2026?

Terence, this is Rob. I'll take both questions. So you're right, we're seeing tremendous performance from Skyrizi and Rinvoq. Very pleased with the progress we're making, obviously, continue to raise our expectations for this year.

As you know, we occasionally update the long-term guidance, while we've been doing that the last few years around the time of the fourth quarter call. We've done that also previously at the JPMorgan conference. So we do refresh long-term guidance. I'd say we're obviously tracking very well against the last long-term guidance we issued.

And we will update that at the appropriate time. But obviously -- and then when you look at Street expectations as well, they have come up, too. And so we're very pleased with the performance, and we'll update that long-term guidance at the appropriate time, but the momentum is clearly there. As it relates to tariffs, I'd say, as it relates to '25, we're fairly insulated from any impact this year given inventory management actions.

But look, without policy details, -- we're not going to speculate on the longer-term impact. We do need to see the outcome of the 232 investigation and how tariffs are ultimately phased in. What I can say is that we do not expect our exposure to be outsized relative to peers. And as I mentioned during the first quarter call, we have a broad U.S. network.

It includes 11 sites that manufacture API, biologics, toxins and small molecules. As a reminder, again, our largest product, Skyrizi, is made in the U.S. for the domestic market. And longer term, we will add more U.S. manufacturing capacity, which is part of the planned $10 billion in capital investment that we announced during the first quarter call. That again includes adding 4 new sites to our U.S. network that will cover API, peptides drug product and devices.

And so we are well positioned. We'll obviously continue to invest in the U.S. I think we're having constructive discussions with the administration on sectoral tariffs. Clearly, the best way to motivate that is through tax incentives as well as a trade agenda that prioritizes innovation.

But we're well positioned as a company, but we're not going to be able to really give you any details until we understand the outcome of the 232 investigation.

The next question comes from Chris Schott with JPMorgan.

Just a couple of follow-ups here. Just on Skyrizi, obviously, meaningful upside to results this year. And I just would love if you'd lay out what in particular is driving this. I guess, specifically, is it all IBD?

Or are you also seeing upside to the derm indications as well? And then second question was just kind of a bigger picture kind of BD question. I know the focus is on strengthening the growth profile 2030 and beyond. But just given the momentum of the core business, it seems as AbbVie could fund significant growth in its pipeline in R&D over the next few years and still have pretty healthy earnings growth.

So just should we think about this still being kind of the string of early stage or mid-stage deals? Or is there appetite to also look at later-stage assets that maybe have more spend upfront, but could also contribute as we get later in the decade?

Yes. Thanks, Chris. It's Jeff. And the momentum on Skyrizi is across the board.

Clearly, we've spent a lot of time talking about the more recent launches of Crohn's and ulcerative colitis. Rob mentioned the Sequence head-to-head trial, which was quite remarkable in what that drove. But really, it's across the board. I mean, particularly continue to be very, very impressed with our momentum in psoriatic disease.

So it's been 7 years since the initial psoriasis approval, and we are still gaining in-play share, really not been observed on a brand this big over that amount of time. And that's across both psoriasis and as I mentioned in my prepared remarks, in frontline PSA derm. So it really is strength across the board. We even see continued momentum in PSA in rheumatology, where our combined share with both Skyrizi and Rinvoq in terms of PSA room is the leading portfolio.

So it really is well balanced.

Chris, I would just add to Jeff's comments that $600 million raise, $400 million of that you could think of as IBD, $200 million in psoriatic. So that's going to put the split of the 17.1 at 11.3 for psoriatic and 5.8 for IBD.

And Chris, this is Rob. I'll take your question on BD. When you look at AbbVie and the diversified growth platform we have today, that's going to provide us with the opportunity to really drive top-tier performance, clear line of sight to growth for at least the next 8 years. So as I think about strategically, the pipeline, external innovation, the investments we're making are really all around what's going to drive growth in the next decade.

We have a clear line of sight based on the portfolio we have today to drive that growth over the next 8 years. And so it's really more about how do we set the company up to grow beyond Skyrizi and Rinvoq. And so we've made, I think, a lot of very compelling investments. And you're right, we -- without any significant LOEs this decade, we have the flexibility to invest more in R&D to continue to acquire external innovation.

And we're going to -- we will absolutely do that. We have, I think, a lot of very exciting programs coming out of our internal pipeline. We look at the progress we're making, particularly in oncology, you look at the combination approaches in immunology. But our BD strategy will continue to be focused on assets that can really drive growth in the next decade and beyond.

And if you just look at the deals we've done, obviously bolstering our pipeline in immunology with novel mechanisms, but also adding important capabilities with oral peptides as well as B-cell depletion approaches. In oncology, we've added some very nice depth in multiple myeloma. We actually have our own program in Etansamig, but we've added 2 trispecific deals, Simcere and IGI to really give us significant depth in multiple myeloma to drive growth for the long term. We've also made a lot of progress in neuroscience across psychiatry, migraine and Alzheimer's.

And then the siRNA transaction with AR gives us a very compelling platform that can generate opportunities across really all 3 of these areas: immunology, neuroscience and oncology and then not to mention our entry into obesity with the Uber deal, which we plan to build upon with more BD. So as I think about the company strategically, we need to continue to invest in early-stage programs that can really drive growth for the company in the next decade and beyond, and we're very well positioned to drive growth in this decade with the portfolio we have today.

Our next question comes from Dave Risinger with Leerink Partners.

Congrats on the phenomenal financial momentum. So my question is, could you please discuss your vision for leveraging your global aesthetics commercial footprint to sell obesity drugs in the future? And also, how are you thinking about potentially adding to your obesity R&D portfolio in the future?

Yes. David, it's Jeff. So this is a very important point. I mean we do have a very strong footprint around the globe.

And what we observed, and it's changed a little bit over the last several quarters, we observed that the sort of a cash pay obesity or weight loss market in our aesthetics practices became the second largest sort of revenue driver for them and in terms of patient flow. So you had the toxins was #1, then obesity and weight loss became #2 and then dermal fillers was #3. Now that since moderated, and it's moderated because of the -- basically the loss of some of the compounding dynamics and the way the clinics were thinking about this. So we -- this was an important -- certainly not the only an important reason for the Gubra transaction because we know that, that's just going to be ongoing demand.

And as we think of a lot of patients who are going to have already tried to cycle through the GLP-1s, whether it was compounding or the branded over time, they're going to want to continue to think about how do they think about weight loss as part of their aesthetic journey over time. And we think we're very uniquely positioned to be able to deliver that to the aesthetic clinics around the world. So again, pretty important in terms of how we would do that, our ability to distribute directly to think about ways that we would handle the cash pay aspects, aspects of thinking about how AI would work and how that interaction would take place across the emerging portfolio and existing core brands that we have.

So that was a big consideration of our deal and certainly attractive.

And this is Roopal talking about R&D -- furthering R&D in obesity space. And that's certainly something we're open to. The asset we have right now is in the amylin class and the things that we were thinking about there were enhanced tolerability, a desirable dosing profile that could drive durability. The issue we see here is many people will start, but a majority of whom will fall off relatively quickly and then not get the benefits of weight loss.

The other considerations are around muscle loss and bone loss. And along those lines of what I just mentioned, if there are other assets that address those similarly to an amylin class and we have an opportunity to combine, that would be something that we'd be very interested in. The other thing we like about the 295 molecule is a neutral pH, which may make it simpler to combine with other assets that address these, I would say, continuing unmet needs.

Our next question comes from Carter Gould with Cantor.

Maybe to change pace and ask on VYALEV. Obviously, you raised the guide there. Should we think about that being primarily driven by U.S. or OUS? I guess, specifically, has the OUS success sort of changed the way you think about the U.S. launch there?

Yes. Carter, it's Jeff. So again, as we mentioned, we're super pleased with the launch in Vyalev. And what we're seeing is just very, very strong demand.

The drug device combination is really transformational. And what we see with the control over the Parkinson's or the advanced Parkinson's disease is you get 24-hour effect. And so that helps manage the motor disorders and the sleep disturbances and throughout not just the day when people are awake, but also through the night. So this quality of life impact and the control of the disease is quite remarkable.

So we're just seeing real demand that's coming through largely across the international markets. So as we've highlighted before, we're very confident that we're going to start to see the Medicare ramp in the U.S. start here in the latter part of the year, and we're right on track for that. but the raise really is largely related to just the core demand. You think about it really the first full year, a $400 million running rate in the international market, very impressive based on the performance of the brand.

The next question comes from Tim Anderson with Bank of America.

I have a question on IRA price negotiation. You guys have a horse in the race again with Vraylar in this upcoming round. You had Imbruvica in the first round. There have been investor fears that this next round of negotiations will be worse than last year, so Trump can make his mark. any assurances you can give us that this won't be the case?

Or can you otherwise provide any color on how those negotiations are matching up with your expectations as you first headed into those negotiations? And then second question on aesthetics. I know you talked about pushes and pulls, a question I've asked in the past. The impact from the GLP-1s on BOTOX and dermal fillers, what's the latest?

Is it helping sales, hurting sales or net neutral?

Tim, it's Rob. I'll take your first question. Obviously, as we go through these negotiations, we don't publicly comment for obvious reasons. And as you know, the price will be public in November, and we'll comment as appropriate at that time.

But as it relates to the IRA, I do think one important notable change as part of the One Big Beautiful Bill Act is the expansion of the IRA orphan drug exemption, Drugs with more than one orphan designation are now exempt from IRA negotiations, which will be a benefit to our own cancer therapy, Venclexta. So we previously would have assumed we had a time line as we model the impact of IRA. Now with this change, we would not expect Venclexta to be negotiated. And that's an example of a good policy change where innovation is being rewarded and not penalized.

But as it relates to the current negotiations, we'll provide commentary once those prices are public.

Yes. And regarding the GLP-1s, I would say, overall, what we see after numerous discussions and working with our clinics, Tim, is that it's really a net neutral. I mean, if anything, if you look at it, I mean, the filler market, where, in some cases, people are interested and as they lose their facial muscle and fat, you think that would be a tailwind for the dermal filler market. And we've seen that, that's just been more afflicted clearly by macro issues and some sentiment issues.

So net-net, we see it as really a neutral effect.

Your next question comes from Vamil Divan with Guggenheim Securities.

On the quarter. So just 2 for me. One on the alopecia areata data you touched on earlier in the call in the press release from yesterday. Wondering if you can just sort of talk about the commercial opportunity for that indication.

Obviously, Rinvoq is a big product and going to get bigger, but just curious how much of an impact that can have on Rinvoq sales? And then second, going back to the aesthetics commentary, maybe you can just give a little more color on what you're seeing on the ground in terms of the impact of the macro? Are things actually getting better in the practices? Or are you seeing an increase in patient flow as maybe the macro sentiment is getting a little better over the last few months?

Yes. So thanks. Yes, it's Jeff. So the data was quite impressive that you've seen, the recovery of the hair growth quite striking relative to other JAK inhibitors that we've seen report out and gain approvals.

So the way that we thought about Rinvoq and the new indications is really sort of the third wave of how we've developed the product. So we had the big rheumatology indications to start out with, and we built atopic dermatitis and the IBD indications. And now we have this next set of indications, GCA, lupus, et cetera, which are all overlapping with the derm and the rum categories where we have this exceptional strength right now. So as we build that out, it's going to be, we think, quite significant.

And we've highlighted that the collection of the next wave of indications would add approximately $2 billion to peak year sales for Rinvoq. Now we're going to have to continue to study this because it's sort of late breaking and understand could we get more momentum coming out of the transformational quality of this data because in the research that we've had with patients with alopecia, clearly, any sort of hair recovery helps out their perception of their disease, their immune disease. But when you look at the potential to get those SALT scores at that level, could we really see more momentum than we've studied the market so far?

We'll have to see. But net-net, to your point, it's a very significant strategy for us that will start to play out here towards the end of the decade, starting in '26, '27, '28, and we're really encouraged with the data. In terms of additional color on the aesthetic, we've seen things pretty stable -- the big issue that has come up has been really the decline across some of the major territories in the dermal filler market. So certainly, given their price points, patients are more sensitive to the price points of the fillers versus the toxins versus BOTOX.

But at the same time, we've seen that the sentiment around the worry over what happens if I become overfilled -- or is that the look that I want? I want a more subtle natural look. And so that's something that we are basically going to deal with pretty substantially here in the second half with our clinics, with our thought leaders and with our trainers to make sure that the consumers can really understand you can just get exceptional results with dermal fillers. And so we see things fairly stable, but we're going to have to do some work basically to make sure that, that market sort of stabilizes and then grows over time.

Next question comes from Steve Scala with TD Cowen.

Two questions. First, on -- back on aesthetics, nothing you have said is particularly encouraging. In the past, the company has pointed to past periods of uncertainty and pointed to the resilience these brands have had during that period. So the question is, why is this economic uncertainty different than in the past?

This one seems to be lingering longer than in past soft periods? Or are there other things that work such as perhaps competition that's also knowying away at these franchises? And then secondly, on the pipeline, so you have an anti-amyloid monoclonal antibody that completed a Phase I trial in April. What is the status of this product?

And could AbbVie go straight to a potentially registrational trial based on imaging as an endpoint?

Yes. I think, Steve, to your point, I think there is a difference between this and some other areas where we've had some economic uncertainty. It's been sort of more short-term recessionary issues. I think the longer-term impact on the pocket book of the consumers has just been more chronic, and we've seen that across even just recent reports on luxury good items and significant issues.

So I do think it's more chronic than we've seen before. Ultimately, I think we'll be able to work through it. We still see high levels of interest in aesthetic procedures, and we do see the target customers complain about issues of their wallet. I also did highlight that I do think something is different in terms of the sentiment around this natural look and worry about being overfilled in terms of the derma fillers.

All of these are addressable. And I also think that we have the right portfolio, and we also have the right disruptive innovations that's pretty close, particularly around the toxin space with our short-acting fast on, fast off TrenibotE. So I do think we're set up for taking advantage of the long-term recovery, and we'll look forward to that as we continue to progress the strategy.

And Steve, this is Roopal talking about Alzheimer's assets. We have a monoclonal antibody 916, which read out as data, I would say, similar to what's already available on market. And that was the around that period, we also acquired the Aliada technology, which is a monoclonal similar to our 916 in that it binds with high potency to pyroglutamated amyloid. And that also has the blood-brain barrier crossing technology via the transferrin receptor, so we can enhance penetration into the CNS.

Also, what's emerging with that asset is a relatively long half-life. Taken together, we are focused on being able to deliver that subcutaneously. And what will happen next year is that we'll be able to get into patients with that next-generational asset. Now jumping straight to Phase III and getting an approval based on imaging.

It's probably where industry and all of us would like to go to save time. I think we're still going to have to demonstrate a favorable impact on cognition along with that. And perhaps that can eventually -- that imaging results can eventually become a predictive biomarker. But at this stage, we're planning on doing the study based on the effect that we have and also reading out on cognition.

Steve, this is Rob. I just want to come back on your aesthetics question. So when I look at this business, as you look at the performance, I think it's important to note, as you look at this, is it market growth versus market share and the market share performance has been stable. And so when I look at this longer term, with low penetration rates being a leader in this space and the innovation that we have coming forward, there's tremendous potential here, gives us a lot of confidence that over the long term, this will be -- is a very good business.

We've had a prolonged economic headwind. And again, this dynamic we're seeing in various markets around market growth and certain dynamics, as Jeff has mentioned, around dermal fillers in certain geographies. But that said, again, given our position, given our ability to, I think, compete very effectively as demonstrated by the market share performance, and we're very excited about the short-acting toxin and the way it could drive an inflection in terms of market growth and market share as well as the other items in our pipeline around fillers. There's tremendous potential here.

And then there was a question asked earlier about the role that aesthetics can play in obesity. And so you think about strategically, we have the opportunity to play in that market as well. And so longer term, we have a great deal of confidence in this aesthetics business. It's been a challenging few years, but the performance on a market share basis has been strong.

It's just the market growth has been challenged, and we will overcome that.

The next question comes from Chang [indiscernible] with UBS.

So when I compare your Skyrizi 2Q sales to prescription trends, it suggests pricing has been quite favorable, which seems at odds with your commentary around low single-digit price concessions. The major missing piece is the contribution from IV IBD induction scripts. So perhaps can you give us some help on the proportion of sales from Skyrizi in IBD now or percentage of number of scripts getting IBD induction? And if we take that into account, is the 1H pricing performance consistent with the full year expectations?

Or should we expect a more meaningful step down in pricing in the second half of the year?

It's Scott. Let me address your question. So I think you're correct. From an overall perspective, the first half of the year, we did see some price favorability.

Now quickly on the volume side, when you look at that IQVIA data as we've spoken about in the past, there is a disconnect from the induction. And that really, I would call that about a 10-point differential that you need to add to what you're seeing in the data to get to the volume trend. But we still do have favorable price in the quarter and also the first half. And there's really a couple of things going on there.

It's really some price gating items that were unique. We also are seeing from some of the information that we've received, the Part D redesign impact will be a little bit more heavily weighted towards the back half of the year. So that was less of a headwind in the first year, but really some pricing gating items. We do expect on an overall basis that pricing to be neutral for Skyrizi.

And on a long-term basis, of course, low single digits, consistent with what we've said. But this year had some anomalies. And so neutral for this year. You will see some negative price in the back half of the year.

The next question comes from Gary Nachman with Raymond James.

Nice quarter. So first, also on Skyrizi. What are you seeing regarding the competitive dynamics in the IL-23 class, especially with J&J's TREMFYA with their new IBD approvals, if that's impacting at all? Or is there just a ton of headroom in the IBD market to absorb that?

And then on neuro, it was very strong in 2Q. Is that mainly volume demand driven across the various products? Any changes with gross to nets that are worth noting? And how much more have you been investing behind the neuro franchise overall given such strong growth that you've been seeing there?

Yes. So thanks for your question on Skyrizi and the competition. We're quite pleased again with the overall performance, the head-to-head trials, our ability to think about the dosing and the convenience and the safety. The profile of Skyrizi is just fantastic across IBD that we've highlighted multiple times.

And I think your point is consistent with how we think about how this market will develop over time. And I think I've highlighted it before. There's actually -- the launches of the '23s really Skyrizi first and now TREMFYA are so new, you really have single-digit patient share capture. This is for total patient share.

We saw the same dynamic in psoriasis where you look at it, it was that way in 2018, 2019. Now 60% of the entire market of patients is in the IL-23 category. So to your point, there's plenty of headroom when you look at the profile of these agents. And certainly, from a capture rate standpoint, we believe that Skyrizi will do very, very well relative to the peers in the IL-23 category. Having said that, we prudently would allocate a certain amount of share capture from a competitor like TREMFYA.

So hopefully, that will help give the perspective. Certainly, the macro perspective is important there. And then in terms of the neuro business, you're right, strong growth rates across the board. Most of that is volume and promotion.

If you look at the migraine business, we have the leading business across all 3 segments of that category. So we're #1 in acute with Ubrelvy, #1 in prevention with QULIPTA and for chronic migraine, where you have the injectors for BOTOX Therapeutic there as well. So there's no cannibalization. All of them grow very well.

We have super powerful share of voice out there that's helping to drive all of that. And you've heard the comments, of course, on VYALEV and Vraylar as well. Scott can highlight also sort of the mix in the quarter on price versus volume.

Sure. Happy to. It's a great question. I mean, as Jeff said, the volume is really driving this business.

When you think about our 2 largest brands, Vraylar and Botox Therapeutics, those are both double-digit -- you did see a little bit of a price benefit from Vraylar in particular, as we look at the Part D redesign impact. So we have a little bit of price favorability. But Vraylar in particular, double-digit growth in volume for the year, double digit every quarter. And we're really seeing that across the board.

On the gross net side, I would say that, especially in the oral CGRP space, Ubrelvy, QULIPTA, we continue to work very closely on the co-pays and making sure that we're get the right gross to net, and we've been very happy with that progress. So there's a little bit of benefit there coming across, but these are -- this is a volume-driven business in a volume-driven therapeutic area.

And maybe in terms of investment going forward, we obviously have substantial investment in the therapeutic area now, but it can take more investment. For example, we are significantly ramping the investment in the U.S. for VYALEV. We would be anticipating tavapadon, as I highlighted in my remarks, this is also shaping up to be a very important product -- this is the oral medication that would be used prior to VYALEV. And so we're planning sales force expansions on that front.

And certainly, Roopal and I both highlighted the study versus topiramate. Now topiramate basically is 40% to 50% of all the generics in the preventative space. And so we will also be assessing on whether or not more representation might enable QULIPTA to basically start to power forward over the long-range plan. But that approach is underway.

But at a macro level, we certainly want to continue to invest into the neuroscience growth rates that we're seeing.

This is Rob. I mean I think it's an important question because we are obviously going to fully invest in neuroscience. It's our second largest therapeutic area. It's the fastest growing in our portfolio.

In fact, we expect to be the largest neuroscience company in the industry next year. We clearly have very strong positions in psych and migraine and emerging leadership position in Parkinson's with VYALEV and tavapadon, as Jeff mentioned. And we also have an opportunity to drive advancement in Alzheimer's treatment through the Aliada platform. You've seen us over the course of the last several years, invest in external innovation.

We've highlighted the Gedeon Richter discovery collaboration in psych, the Gilgamesh opportunity that we entered into last year in mood disorders. I mentioned Aliada, very excited about that next-generation A-beta antibody in Alzheimer's, again, with a unique shuttle platform. And then as I discussed earlier today, the siRNA opportunity with ADARx will play a role in neuroscience as well. And so we are fully investing in neuroscience.

We look forward to maintaining our leadership position there. It's obviously performing exceptionally well. You saw across the board. Every brand exceeded expectations in neuroscience this quarter, and we're going to keep fueling that engine.

Thanks, Gary. Operator, we have time for one final question.

Congrats on yet another solid set of results. I think most of my questions have been answered at this point. Just one bigger picture question on the oncology franchise, maybe for Roopal. You've mentioned that you're watching the PD-1 VEGF class.

Just curious if you have any updated thoughts on the broader landscape, how AbbVie is positioned? And given there's been a lot of BD activity there, what would it take for AbbVie to make a move here?

Yes, it's Roopal. So yes, we're monitoring that class. There are several assets that are revealing data over time. But it is something that we're interested in and looking.

And in particular, how we think about that is what can partner well with our internal ADC platform. And I think this could -- that mechanism of that class could create an opportunity. And how we think about ADCs is we look for a good target. We look for high tumor expression of that target versus what we would observe on healthy tissue that can allow for potential patient selection using biomarkers, if appropriate, that allows you to optimize benefit risk and enhance tolerability.

The platform that we have with the linker technology and our emerging topo warhead, we're seeing, I would say, very little spill, meaning low rates of alopecia, stomatitis, diarrhea, the things that you see with chemo and some other ADCs. So safety and tolerability are critical as a strategy. And if we see a partner asset that we can combine with in a variety of different indications, that is something that we would be interested in for sure.

That concludes today's conference call. If you'd like to listen to a replay of the call, please visit our website at investors.abbvie.com. Thanks again for joining us.

Thank you, and that concludes today's conference. You may all disconnect at this time.