Abbvie Inc (ABBV) — Q1 2026 Earnings Call Transcript

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 and Chief Commercial Officer; Roopal Thakkar, Executive Vice President, Research and Development and Chief Scientific Officer; and Scott Reents, Executive Vice President and 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 our 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 is off to an excellent start to the year, with first quarter results exceeding our expectations across our diverse portfolio. We are delivering top-tier growth and continue to strengthen our long-term outlook with pipeline advancements and strategic transactions. Turning to our first quarter performance. We achieved adjusted earnings per share of $2.65, which is $0.07 above our guidance midpoint. Total net revenues were $15 billion, beating our expectations by $300 million and reflecting robust sales growth of 12.4%. I'm especially pleased with the momentum in immunology and neuroscience, which are both delivering share gains in growing markets. Based on this strong performance, we are raising our full year adjusted earnings per share guidance by $0.12 and now expect adjusted EPS between $14.08 and $14.28. Turning now to R&D. We are making meaningful progress advancing programs across all stages of development. Recent highlights include the U.S. regulatory submissions of Rinvoq for alopecia areata, giving us a potential new source of growth in dermatology and Skyrizi subcutaneous induction in Crohn's with an approval decision expected later this year. We also saw promising interim data from our Crohn's platform study, combining Skyrizi and our own alpha-4 beta-7 antibody, which has potential to deliver transformational efficacy. In obesity, we announced early-stage data for our amylin analog ABBV-295 with very encouraging weight loss results. In oncology, we are now expecting the regulatory submission for temab-A by the end of this year, which is earlier than our previous expectations. We also expanded our emerging oncology pipeline by closing the Remagen agreement, giving us a novel PD-1/VEGF bispecific antibody. We will continue to augment our portfolio with business development to access external innovation. And given our strong growth outlook, we have significant financial capacity to pursue both early and late-stage opportunities. Lastly, as part of AbbVie's $100 billion commitment to U.S. R&D and capital investments over the next decade, we recently announced construction of several new manufacturing sites. This includes a $1.4 billion investment to build a pharmaceutical manufacturing campus in North Carolina, and a $380 million investment for two new plants in North Chicago. These strategic investments will strengthen AbbVie's ability to produce medical breakthroughs in immunology and neuroscience, oncology and obesity. In summary, the fundamentals of our business are strong, and we are well positioned to deliver top-tier growth for the long term. With that, I'll turn the call over to Jeff for additional comments on our commercial highlights.

Thank you, Rob. I'll start with the quarterly results for immunology, which delivered total revenues of $7.3 billion reflecting impressive sales growth of $1 billion. Skyrizi total sales were $4.5 billion, up 29.2% on an operational basis, exceeding our expectations. We continue to demonstrate exceptional performance across psoriatic disease, where we are gaining share and have clear leadership over all biologics and orals by a very wide margin. The psoriatic market is growing robustly, and we feel extremely confident in Skyrizi's best-in-class profile, including high and durable efficacy on both skin and joints as well as simple quarterly dosing, which collectively gives us a distinct advantage relative to all the existing and emerging therapies in this area and we continue to generate compelling evidence to support Skyrizi as the preferred treatment option for psoriatic disease. At the recent AAD meeting, we presented new data highlighting Skyrizi's strong efficacy in genital and scalp psoriasis, which are very difficult to treat areas, often leading to significant social and emotional burden to patients. The FDA has recently approved adding the new study results in these high-impact areas to the SKYRIZI label. We also now have long-term efficacy and radiographic data in psoriatic arthritis demonstrating Skyrizi's durable efficacy with nearly 90% of patients showing no radiographic progression through five years of treatment. This data will enhance our existing leadership in the important PsA segment where Skyrizi is the frontline in-play patient share leader in both the dermatology and rheumatology segments. Performance also remains very robust in IBD, where Skyrizi is on track to deliver more than 30% global sales growth across Crohn's disease and ulcerative colitis this year. Competitive dynamics within IBD are playing out in line with our expectations, with Skyrizi continuing to capture a leading share of total new patient starts in the U.S. in the quarter, including very significant in-play leadership in the frontline setting, which is the strongest signal of overall physician preference for Skyrizi. I'm also pleased with the compelling results from our recent subcutaneous induction study for Crohn's with data, particularly in the bio-naïve population that we believe compares very favorably versus the competition and we look forward to providing an additional dosing option for physicians and IBD patients later this year. Turning now to Rinvoq, which is also performing above our expectations. Global sales were $2.1 billion, up 20.2% on an operational basis. Demand remains strong across all of Rinvoq's indications. We are now achieving high-teens in-play patient share and are seeing a nice inflection in prescriptions across gastroenterology, especially in ulcerative colitis, following the recent expanded label supporting access to Rinvoq earlier in the treatment paradigm for IBD patients. We are also planning for the potential near-term commercialization of two additional indications, alopecia areata and vitiligo, which will meaningfully expand the Rinvoq label and where we have also recently expanded our field force to support these emerging opportunities. Lastly, in immunology, HUMIRA global sales were $688 million, down 40.3% on an operational basis, reflecting biosimilar competition and in line with our expectations. Moving to neuroscience, where we continue to outperform our expectations as well. Total revenues were nearly $2.9 billion, up 24.3% on an operational basis. In migraine, our leading portfolio continues to gain market share with Ubrelvy and Botox Therapeutic each delivering robust double-digit sales growth. In psychiatry, Vraylar global sales were $905 million, up 18.4%, reflecting strong prescription growth in both bipolar disorder and adjunctive major depressive disorder. Vraylar faces limited branded competition, and we expect continued momentum following the introduction of new lower doses, allowing prescribing flexibility as well as pediatric usage. Moving to Parkinson's disease. We continue to see encouraging uptake for VY-ALEF, which is on track to achieve blockbuster revenue this year. Total sales were $201 million, up approximately 10% on a sequential basis. We are also preparing for the potential approval and launch of tavapadon in the U.S. later this year, an exciting new oral treatment for patients with Parkinson's and a very complementary addition to our growing Parkinson's portfolio with NUPLAZID and Duopa. Tavapadon has demonstrated strong efficacy as both a monotherapy as well as an add-on to the standard of care, and we believe it will be a sizable commercial opportunity. Moving now to oncology, where total revenues were more than $1.6 billion, down 3% on an operational basis. Venclexta continues to perform very well, especially in CLL as combination use with BTK inhibitors are emerging as a preferred fixed treatment duration globally. We've recently received full approvals in the U.S. and the U.K. as well as a positive CHMP opinion for Venclexta's use with BTKs for that fixed treatment course. Total Venclexta sales were $770 million, up 9.7% on an operational basis. Continued sales growth from other oncology products also helped to partially offset the expected sales decline for IMBRUVICA, which was down 24.7% due to IRA pricing and competitive share pressure. Moving now to aesthetics, which delivered global sales of nearly $1.2 billion, up 5.1% on an operational basis. Botox Cosmetic total revenues were $668 million, up 17%, reflecting a favorable price comparison in the U.S. as well as modest market growth globally. Juvederm global sales were $232 million, down 2.9%, reflecting continued headwinds in key dermal filler markets. While economic headwinds have continued to impact market conditions globally, the long-term prospects for the category remain attractive given high consumer interest and low penetration rates. As the industry leader, we are investing in promotion and innovation to support patient activation. I'm particularly excited about the potential for a fast-acting short-duration toxin which, once approved, we expect will be market expanding and complements our toxin portfolio very nicely. While that asset is delayed in the U.S., we continue to anticipate approval and launches this year in key international markets, including Europe, Canada and Japan. So overall, I'm extremely pleased with the execution and continued strong performance across our commercial portfolio. And with that, I'll turn the call over to Roopal for her comments on our R&D highlights.

Thank you, Jeff. We continue to make good progress across our pipeline. I'll start with dermatology programs in immunology. As Jeff just mentioned, new data was presented at the recent AAD meeting, highlighting SKYRIZI's strong efficacy in genital and scalp psoriasis and long-term efficacy, including radiographic data in psoriatic arthritis. These recent presentations add to the growing body of evidence supporting Skyrizi's best-in-class profile in psoriatic diseases. Its strong durable efficacy on both skin and joint measures, favorable safety and tolerability profile and convenient quarterly maintenance dosing give us confidence that Skyrizi will continue to be the preferred first-line treatment option for patients with psoriatic disease. Additionally, discussions are ongoing with the FDA regarding revised label language related to tuberculosis evaluation for Skyrizi. While TB monitoring has become fairly routine prior to initiating treatment with biologics, updated language would allow health care providers to use their clinical judgment. Moving to Rinvoq. The regulatory application for alopecia areata was recently submitted to the FDA; approval decisions are anticipated later this year in Europe and Japan and in early 2027 in the U.S. Phase III studies for both Rinvoq and lutikizumab are progressing well and remain on track for 16-week topline results in the second half of this year. Turning to gastroenterology. All co-primary and key secondary endpoints were met in the Phase III AFFIRM study with Skyrizi's subcutaneous induction in Crohn's disease, demonstrating very high levels of endoscopic response and clinical remission. While not a direct head-to-head comparison, when matching these data against results from the Skyrizi IV induction program, the subcutaneous induction achieved numerically higher results across key endpoints. We are extremely pleased with the strong performance demonstrated by subcutaneous induction, especially considering that this study enrolled a very difficult-to-treat patient population. Two-thirds of the patients received prior advanced therapy with half failing two or more therapies and a third failing anti-TNF or a JAK inhibitor. Data in those who had not previously received advanced therapy were particularly noteworthy, where 61% of Skyrizi patients achieved endoscopic response and 73% achieved clinical remission at week 12. This is 45 points higher than placebo on both measures. These are very impressive results, which will continue to support first-line use. These data reinforce Skyrizi's best-in-class profile and provide an additional induction dosing option for patients with Crohn's disease. Our U.S. regulatory application was recently submitted with an approval decision anticipated later this year. Subcutaneous induction for ulcerative colitis is also being assessed and we will be discussing options with health authorities. Next, on to other gastro programs. An interim analysis was recently completed on our Crohn's disease platform study. In the cohort evaluating Skyrizi plus our novel anti alpha-4 beta-7 antibody, ABBV-382, the combination resulted in a higher rate of endoscopic remission at week 12 and at week 24. The rate was double that of either monotherapy arm. Endoscopic remission was achieved by approximately 42% of patients receiving the combination at week 24. These results were observed in a broad population that had severe and refractory disease, which included 82% advanced treatment failures and 53% of patients failing two or more advanced treatments. Of the patients that previously received advanced therapies, 63% failed an agent with an overlapping mechanism with the combination and 20% failed a JAK inhibitor. At baseline, patients had a mean Crohn's Disease Activity Index of 325 and a Simple Endoscopic Score of 14, which represents a very treatment-refractory patient population. Achieving this level of endoscopic remission in this setting is a particularly meaningful achievement as this endpoint is an objective measure of mucosal healing and is associated with long-term benefits, including reduced rates of hospitalization, surgery and disease progression. Safety of the combination was consistent with the profiles of the monotherapies; no new signals were observed. These results demonstrate the potentially transformative level of efficacy that our novel combination can achieve. The study is expected to complete in the third quarter with presentation at a medical meeting anticipated by early next year. A Phase IIb study is planned to begin this summer in patients with Crohn's disease and ulcerative colitis to evaluate Skyrizi in combination with both ABBV-382 and with our extended half-life TL1A antibody. In parallel, we will be evaluating Phase II acceleration options for Skyrizi plus ABBV-382 in Crohn's disease. In the Skyrizi plus lutikizumab cohort, the combination did not sufficiently differentiate from monotherapy Skyrizi and will not be moving forward. In the early-stage immunology pipeline, we are nearing completion of a Phase I study for an IRAK4 inhibitor, ABBV-848, and plan to begin a Phase II study in rheumatoid arthritis later this year. This potent inhibitor has the potential to provide biologic-like efficacy, a favorable safety profile with no box warnings and convenient once-daily oral dosing. I will now discuss neuroscience. Topline analysis was recently completed on our Phase II trial evaluating ABBV-932 in bipolar depression. In the study, the overall difference observed between the drug treated and placebo groups was not statistically significant. However, in a prespecified subgroup analysis of bipolar I patients an efficacy signal was observed. The safety profile of ABBV-932 was generally similar to placebo, including rates of extrapyramidal events, demonstrating the potential for a more favorable tolerability profile compared to Vraylar. We are evaluating next steps to continue ABBV-932 development in bipolar I patients. Dose escalation work continues for emraclidine in both schizophrenia and elderly patients. In schizophrenia, we have cleared the 100-milligram dose and will begin evaluating 150 milligrams. Phase II studies in monotherapy and adjunctive schizophrenia as well as psychosis related to Alzheimer's, Parkinson's and Lewy Body Dementia are planned to begin in the fourth quarter. Moving to our psychedelic-assisted brain programs. Additional data from an ongoing Phase II study in major depressive disorder will be available this year. Several studies are planned to begin in 2026, including a Phase III trial for single course acute treatment in MDD, a Phase IIb evaluating repeat dosing for chronic use in MDD and a proof of concept Phase II in post-traumatic stress disorder. And in Parkinson's disease, we remain on track for an approval decision for tavapadon in the third quarter. Turning to our solid tumors program in oncology. Temab-A is progressing well across a broad range of tumor types. At the upcoming ASCO meeting, early-stage safety and efficacy results for Temab-A in head and neck and ovarian cancers will be presented. Based on these results, we are engaging with regulators regarding ways to accelerate programs for Temab-A plus pembrolizumab in frontline head and neck cancer and Temab-A plus bevacizumab in frontline ovarian cancer. In colorectal cancer, we have made a decision to update our strategy in the third-line-plus setting and will now focus the pivotal program on Temab-A in combination with bevacizumab in an all-comers population as opposed to pursuing monotherapy in c-MET selected patients. Targeting all comers will allow Temab-A to reach a substantially broader population. Temab-A plus bevacizumab demonstrated improved response rates and disease control versus current standard of care regardless of c-MET expression levels. Treatment with Temab-A at 2.4 milligrams per kilogram plus bevacizumab achieved an objective response rate of 30% and a confirmed disease control rate of 97% compared to rates of 0% and 70%, respectively, for standard of care in the control arm. Given the expanded patient population for the all-comers Phase III trial, we anticipate faster enrollment compared to the study in c-MET selected patients. Initial data readout is expected in the second half of next year. In lung cancer, Temab-A received its first Breakthrough Therapy Designation as a monotherapy in second-line-plus EGFR wild-type non-squamous non-small cell lung cancer. We are in the process of planning a Phase III trial in this setting. In small cell lung cancer, a Phase III trial for monotherapy, ABBV-706, recently began in relapsed refractory patients. Two Phase II studies evaluating ABBV-706 triplet combinations in frontline patients are also planned to initiate this year. These trials will evaluate ABBV-706 in combination with atezolizumab plus T-cell engagers. Moving to AbbVie's ADC dose escalation data in late-line metastatic castration-resistant prostate cancer will be presented at ASCO. Based on these results, we are in the process of discussing acceleration options with regulators in order to advance into Phase III trials as quickly as possible. We also continue to augment our solid tumor pipeline through investments in external innovation, including one with Castro Therapeutics; we recently began a Phase I study to evaluate a pan-KRAS inhibitor in advanced solid tumors harboring KRAS mutations. This next-generation inhibitor has the potential to provide an improved efficacy and safety profile based on increased potency and specificity against the most relevant KRAS mutations, while sparing HRAS and NRAS. Our strategy is to combine this pan-KRAS inhibitor with Temab-A in pancreatic, lung and colorectal cancers. In hematologic oncology, our Phase III trial evaluating monotherapy ABBV-383 in third-line-plus multiple myeloma is tracking ahead of schedule. We anticipate a response rate readout in the third quarter with potential to also see an interim analysis on progression-free survival. If this interim analysis is positive, regulatory submissions would occur later this year. Progress continues in earlier lines of therapy as well. The increasing use of anti-CD38 antibodies in earlier treatment settings is driving a need for CD38-free BCMA combinations, particularly those that can provide the convenience of monthly BCMA dosing combined with an oral agent. Plans are underway for a Phase III study evaluating ABBV-383 in combination with an oral partner in second-line-plus patients, including those that were exposed or refractory to a CD38 antibody or who lost response to a BCMA CAR-T or ADC. Moving to other areas of our pipeline. In aesthetics, the FDA issued a complete response letter for our product application related to manufacturing questions. The CRL did not identify any issues related to safety, efficacy or labeling nor has the FDA requested any additional clinical trials be conducted. We will be working closely with the FDA to address their feedback and determine next steps for resubmission. In obesity, positive topline results were announced from a multiple ascending dose study, evaluating our long-acting amylin analog, ABBV-295. In the study, ABBV-295 demonstrated clinically meaningful weight loss of nearly 10% after only 12 weeks of treatment despite enrolling a predominantly male nonobese population. ABBV-295 was well tolerated with mostly mild and transient GI-related adverse events; no cases of severe nausea, vomiting or diarrhea were reported. These early results are encouraging and reinforce our view that our long-acting amylin analog has the potential to provide strong weight loss with favorable tolerability. In the next phases of development, higher doses of ABBV-295 will be tested in patients with obesity, including every-other-week and monthly regimens. Interim data from our Phase I study in obese patients are anticipated later this year. Our Phase II program is now expected to begin in the third quarter. To summarize, significant progress continues with our pipeline, and we look forward to additional important data readouts, regulatory submissions and approvals throughout 2026. With that, I'll turn the call over to Scott.

Thank you, Roopal. Starting with our first quarter results. We reported adjusted earnings per share of $2.65, which is $0.07 above our guidance midpoint. These results include a $0.41 unfavorable impact from acquired IPR&D expense. Total net revenues were $15 billion; this reflects top tier growth of 12.4%, including a 2.1% favorable impact from foreign exchange. Adjusted gross margin was 83.6% of sales. Adjusted R&D expense was 15.1% of sales, and adjusted SG&A expense was 22.7% of sales. The adjusted operating margin ratio was 40.8% of sales, which includes a 5% unfavorable impact from acquired IPR&D expense. Net interest expense was $645 million, the adjusted tax rate was 15.4%. Turning to our financial outlook. We are raising our full year adjusted earnings per share guidance to between $14.08 and $14.28. Please note that this guidance does not include an estimate for acquired IPR&D expense that may be incurred beyond the first quarter. We now expect total net revenues of approximately $67.3 billion, an increase of $300 million. The impact from foreign exchange on full year sales growth remains roughly in line with our prior expectations. This upgraded revenue forecast includes the following approximate assumptions for several of our key products and therapeutic areas. We now expect Skyrizi global revenues of $21.6 billion, an increase of $100 million, reflecting demand growth in psoriatic and IBD indications. Rinvoq global sales of $10.2 billion, an increase of $100 million, reflecting strong performance in the rheumatology and gastroenterology indications. Total Neuroscience revenues of $12.6 billion, an increase of $100 million, reflecting momentum across the portfolio. Moving to the P&L for 2026. We continue to forecast 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 now anticipate an adjusted operating margin ratio of approximately 47.5% of sales, in line with our previous expectations after including the roughly 1% unfavorable impact of acquired IPR&D expense incurred through the first quarter. We also now expect adjusted net interest expense of approximately $2.7 billion, a reduction of $100 million, primarily related to favorable rates on our debt issuance. Turning to the second quarter. We anticipate net revenues of approximately $16.7 billion. This includes an estimated 0.6% favorable impact from foreign exchange. We are forecasting an adjusted operating margin ratio of approximately 50%. We expect adjusted earnings per share between $3.74 and $3.78. This guidance does not include acquired IPR&D expense that may be incurred in the quarter. In closing, AbbVie continues to deliver outstanding results and our financial health remains very strong. Our capital allocation priorities remain focused on the future as we are investing in the business at record levels, have financial flexibility to pursue compelling business development and returning capital to shareholders through our strong and growing dividend. With that, I'll turn the call back over to Liz.

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, first question please.

So appreciate all the metrics you have on Skyrizi, but I wanted to get your thoughts on the competitive landscape, particularly with the rollout of an oral competitor — are you thinking about its impact on Skyrizi going forward, if any? And give us some color on your counter-detailing messages to practitioners regarding the product as you enter this period with more intensive competition.

Yes. Thank you, David. It's Jeff. I'll give you some flavor on that. As I mentioned, it's just such an exceptional product. We see in our audits and our trackers that over the last couple of quarters despite incredibly high share, really over four times basically the in-play share and total share versus the next leading competitor, our new prescription (NBRx) has accelerated and continued to hit all-time highs. And that's because of a few of the items, right? The superiority data that we have on skin clearance is just exceptional. So we have head-to-head trials in five mechanisms in psoriasis, including the two oral agents. We can show category-leading durability in the real world. It's just exceptional adherence given the dosing cycle and the ability to keep the disease controlled. We have that leading psoriatic arthritis indication with that new five-year joint stability data that Roopal and I highlighted and then this new data on hard-to-treat areas like the scalp, the genitals, the hands and feet — head to toe for Skyrizi, so to speak. So those are just really, really powerful messages to the physicians who write this medication. I would say there's other things around the oral competitors you highlighted. Look, the launch is quite early. The way that we look at this is, certainly, we're able to communicate that it's not an oral Skyrizi — the efficacy parameters are quite a bit lower when you match all the controls. You understand the populations, which our medical teams and our commercial teams are able to highlight. Certainly, psoriatic arthritis is a huge market value driver, and there's not a lot of evidence there for the oral competitor. There's also some complexities really just even around an oral in the adherence there, and we have some data and evidence on the orals in the category as well. So we're well prepared for this dynamic. So we think that we can navigate this competitor quite well. And we may see, in fact, we saw it with Otezla over a decade ago that there's going to be some market expansion as well. So again, the teams are prepared. We're very confident, and hopefully, that gives you a little bit of flavor of the dynamics in the market.

And David, this is Rob. What I would add is, I mean, we obviously contemplate competition when we provide guidance. We've obviously now once again taken up the guidance for Skyrizi. We continue to see upside to consensus forecast for Skyrizi going out every year and growing each year. And so we have a tremendous amount of confidence. We are well aware of the competition that's coming in. We factored that in, and you can see the asset continues to perform exceptionally well.

Just first one for me is on the Skyrizi alpha-4 beta-7 program. Can you just comment a little bit on what dosing looks like for this combo and where you see this fitting into the competitive landscape? So is this kind of a second-line drug post-Skyrizi or something that could eventually actually get to frontline? And the second question is just maybe building on that and looking at kind of the broader immunology and inflammation competitive landscape. It does seem like there's significant development across the space. I think the Street is increasingly concerned about what this means relative to your portfolio. So can you just kind of address how you think about sustaining the competitive position you have in immunology and how important the Skyrizi combo is, your ability, again, freedom to operate with BD in immunology. Just help us a little bit in terms of how you're envisioning that playing out over time.

It's Roopal. I'll start. The dosing — I would say, Skyrizi, you know the dose, it's already in the label. So the other assets, ABBV-382, the alpha-4 beta-7 and the TL1A, the goal there is to optimize those. So in fact, while we start gearing up for a Phase III study, we have a Phase IIb plan. We had preplanned that ahead of time. And in this quick interim look that we have had we've already observed a non-flat slope, meaning an exposure correlation with ABBV-382, meaning patients with higher exposures did better. So what we'll do in the Phase IIb is in fact study a higher dose of ABBV-382 in combination with Skyrizi. So there's a potential that the efficacy could go even higher. The goal with this one will be likely monthly dosing, co-formulation work is ongoing. And while we're finishing that work, we'll also be speaking with regulators and there's a potential to further accelerate. I don't think we need to wait for the Phase IIb to be totally finished. If we see something while we're conducting the trial, we can pivot relatively quickly. We would anticipate starting, I would say, roughly where we sit today in about two years in the Phase III or even sooner. And the team will be looking at ways to accelerate. And as I stated, the TL1A will be added into this platform as well, and we'll be studying ulcerative colitis along with Crohn's. So as you think about IBD and competitive dynamics, what you see coming from AbbVie is next-generation therapies and really raising the bar on efficacy, as we stated on the endpoint in my opening remarks, we doubled the endoscopic data. And that's really what's most critical. It's the most objective and that's what clinicians are looking for. So as we look to the future, you see that what we're doing, we see other competitors entering. But we see these as monotherapies and even in the Phase II data observed to date, regardless of mechanism, the data do not differentiate from where we sit today with Rinvoq and Skyrizi. So the goal here for the whole portfolio that we've spoken about is to raise that standard of care meaningfully higher. And again, Rinvoq and Skyrizi do that very well today even against emerging competition. And the data that I speak about are battle-tested Phase III data in very difficult-to-treat populations. That's going to hold for the near term, and we have not seen a competitor that can beat that other than us with our own combinations, and we have more to come. So that's, I think, the way to think about how we think about immune therapeutics.

And Chris, this is Rob. I'll just add to Roopal's comments. The way we've been thinking about business development over the last couple of years is to support that strategy. So you've seen us add through business development new mechanisms, TL1A, IRAK4 and others as we think about this combination approach. We acquired Nimble to give us the oral peptides capability. So that obviously plays an important role in the future of immunology. And then I'd say the one that doesn't get enough attention is the Capstan acquisition with the B-cell depletion approach with the in vivo CAR-T platform. As we think about the future of immunology, now we're thinking about growth beyond Skyrizi and Rinvoq, we certainly see a trend there. And so we've been very active with business development over the last couple of years to add depth to our immunology pipeline so that we can continue to remain ahead of the competition. And we have a tremendous amount of confidence given our long-term experience here. We obviously have a commercial powerhouse, but I'd say our R&D organization understands the space very well. And I think we positioned ourselves for long-term growth.

Just wanted to double click on the IRAK4 that you are developing in RA. So this is a space where after HUMIRA, there's not a lot of options which are safe as well. So what gives you excitement about IRAK4 compared to what is out there in the world in terms of therapies which are being tested in immmunology because is trying to become a win without the box warning here?

Thanks, Mohit. It's Roopal. We have very early data. This is a partnership, and we saw some clinical data in China in a small study. And what we observed there was biologic-like efficacy — similar to existing therapies, including the anti-TNF class — and what we saw preliminarily in that data showed a relationship with PK and response rates. So we have the opportunity here to do this Phase IIb study to see if we can push efficacy even higher. And what we like about that is it's another oral. And potentially the safety profile as it's played out to date, we don't anticipate a boxed warning. So that would be a differentiator versus the anti-TNF class and the JAK inhibitor class. So that's what gets us excited about this particular molecule ahead.

Congratulations. I wanted to ask you, first, if you could provide more color on your opportunities for an extended half-life IL-23 and also your oral peptide IL-23. Do you still plan to enter the clinic with those this year? And then just on your combos, I'm curious if you plan to look at those for first line or save those for more refractory patients?

It's Roopal. So yes, we do have an asset called ABBV-547, which you'll hear more about. That is our asset based on all of our experience with Skyrizi and IL-23 inhibition and this is what we'd like to advance. And this would be a longer-acting version. And to your point, the dosing has already initiated. Along those lines, we also anticipate dosing our long-acting IL-23/TL1A bispecific antibody and the Nimble anti-IL-23 oral peptide asset; both of those will be first-in-human this year. The goal for the long-acting is to be slightly longer acting than Skyrizi but not too much longer acting. And the reason for that is that when we take all these factors given that Skyrizi is already available as quarterly, and that is very, very convenient and the data are all very compelling when you look to the maintenance data. When you look at Skyrizi, which extends well beyond week 16, we've demonstrated PASI 100 responses of approximately 60%, PASI 90 responses exceeding 80%, and that's already happening with quarterly dosing. And what I would say there is similar to what Jeff had stated, we also are focused on all of our assets on difficult-to-treat manifestations that includes genital and scalp psoriasis that Jeff has mentioned. Now the other important fact here and why I said the long-term duration is important, is that 30% or so of patients with psoriasis will go on to develop psoriatic arthritis. And again, that's why durability and long-term data are very important. Now the reason I made the comment on the half-life of where we want it to be, we want to offer choices in the future. And that will matter, I would say, to most clinicians who want to individualize the therapy. For example, on a longer half-life, if an infection, for example, were to occur or there's a tolerability issue and you have a very, very long half-life biologic, the prolonged pharmacologic persistence could limit the ability to rapidly discontinue therapy. And also, you could have clinical scenarios that may necessitate switching therapies prior to full washout. And if you have overlapping mechanisms of action that could pose challenges. So we are targeting roughly two to 2.5 times the half-life of where Skyrizi is today, and that would create another option and that would be along with the oral that I said would also be focused on a slightly longer half-life than what we see today for orals, because what we know and Jeff pointed this out, adherence matters with orals. We see it with Rinvoq, but we have very potent efficacy. For the oral from Nimble, we would like to see higher potency and a longer half-life in case someone slips up and misses a dose. So that's how these are being developed. And as you stated, they're both in the clinic this year. So we anticipate data hopefully by next year, if not sooner. And then on the combo positioning question, the data that we have to date are in an all-comers population, and you see efficacy particularly in refractory patients. And when we've seen that with Skyrizi and Rinvoq and you pivot to a treatment-naïve population, the efficacy gets even higher. So we are not going to restrict at all how we would study patients because it's important to clear second line and third line and even come after Skyrizi. In fact, we had Skyrizi patients in the study. We had vedolizumab patients in this study. We had Rinvoq patients in the study. That's an important market because second and third line continue to evolve and grow. But in IBD, the frontline is also important. Many of our clinicians want to tackle the inflammation right away in the best possible way they can. Because with gut inflammation, you can run into problems, it results in hospitalizations, structuring and irreversible damage that can result in surgeries. So nobody wants that. So if you have the best therapy, we believe many clinicians will want to use that early on in the course and not hold out. So we're very excited about the data that we've observed because we see that high level of efficacy in this interim analysis across different lines of therapy in IBD.

Great. Rob, I was just hoping you could elaborate on your thoughts on M&A. Obviously, it's been a very active year so far across the space, seeing companies lean in really at that kind of $5 billion to $10 billion deal size. You mentioned comments on immunology and some of the work you guys have done on the early-stage side. But do you see a need here to maybe be more aggressive and also push into other areas quicker than what you're currently doing? Would just love your broad high-level thoughts there.

Terence, it's Rob. So I'll take that question. So yes, we have been and continue to be very open to acquiring external innovation, really with a major focus for us in neuroscience, oncology and obesity. And to the extent we see a differentiated asset in any of these areas, whether early stage, late stage or even on market, we are very willing to pursue it. I mean, today, we have an on-market portfolio and an emerging pipeline that gives us a clear line of sight to very strong growth into 2030. So we are operating from a position of strength and we have ample financial capacity. So if you think about over the last two years, we have added significant depth to our pipeline, including deals to add new mechanisms. I see each of these opportunities as an opportunity to really drive growth in the next decade and beyond. But that said, while we don't need business development to deliver top-tier growth this decade, we're not opposed to near-term revenue drivers that are differentiated in our core areas of focus.

Just two on Skyrizi, please. So first one is when I look at the 1Q Skyrizi sales, you look at it versus the IQVIA scripts, it looks like net pricing is flat. So slightly better than that low single-digit erosion you guided. I guess, first, can you clarify if there were any one-off items in 1Q for Skyrizi? Or is that discrepancy from IBD and IV induction. And then how should we think about that pricing step down through the year, if you are on track for low single-digit decline? And then just following on, successful exclusivity extension to 2037, what's your confidence in extending Skyrizi's loss of exclusivity? Is there any timelines you have there? Or any signals you have for potential biosimilar settlements?

This is Scott. I'll take your first question regarding Skyrizi pricing. You are correct. In the first quarter, Skyrizi pricing was relatively flat. That's really just a comparison issue on a year-over-year basis in the quarter, a gating, if you will. On a full year basis, we do continue to expect low single-digit pricing for the full year. So that means while we've not given specific gating guidance, you'll see continued low single digits for the remainder of the year. And I think that when you think about that price, that's something we've talked about — low single-digit pressure in the immunology franchise across the board from rebates to price over time. And so Skyrizi is going to be very consistent with that. There was a slight amount of inventory destock as well. So the total demand number was consistent or right around 30%. I think that's consistent with what you would have seen in IQVIA.

And then to your question on exclusivity, this is Rob. Although Skyrizi's composition of matter patent expires in 2033, we do have later expiring IP granted and in process that embodies Skyrizi significant innovation. And this includes patents expiring in the U.S. in the mid-2030s and later. Now it's important to note that regulatory data protection for Skyrizi does not expire until 2031. So we do not expect to see biosimilar application filings until the end of this decade. But clearly, we have a strong track record of vigorously defending our patents and protecting our innovation, and I would expect that to continue.

I have one for Roopal on the PD-1/VEGF bispecific. Given the asset is relatively behind some of the other PD-1/VEGF agents we all know, is there any angle or differentiation to make up for lost time? And then sticking with oncology rules, what should we envision for Temab-A? Do you see this being a transformational kind of readout given a competitive space in frontline settings?

For the PD-1/VEGF bispecific, the key for that and what you've heard previously from us and other deals that we just talked about, the DLL3 TCE. The key for these assets are in combination with our emerging ADC portfolio, in particular, Temab-A where I highlighted some readouts to come at ASCO. And that for us is the key looking forward, especially across colorectal cancer and lung cancer; I noted combinations in pancreatic cancer today. So this is where the innovation occurs — where we're going to use our ADCs wherever we can to replace chemotherapy, provide higher efficacy, and potentially longer durability because of better tolerability. And if the data point us in this particular direction, you could have a biomarker population so physicians are able to individualize care and optimize that benefit-risk. So you would see an efficacy contribution from ADCs with an asset like the PD-1/VEGF bispecific. The other place that's under consideration is in the angiogenesis space in ovarian cancer. There could be potential for the PD-1/VEGF bispecific there. So you can see how it can be introduced across multiple tumor types. And regarding DLBCL, discussions will be ongoing with the current readout where we saw improved PFS and no detriment to OS; that discussion is ongoing. And then we still have the potential for second-line DLBCL and even frontline DLBCL data this year. And that frontline is Temab-A plus R-CHOP. So I would say a very simple and potentially easily adoptable regimen. So again, potential for readouts this year. And if you do see a benefit there, I would say the frontline is the largest opportunity for Temab-A.

First, for the additional indications for Rinvoq. As they start to come through, vitiligo and alopecia areata will be next. Are you still thinking all those indications can be $2 billion in aggregate or are you getting more optimistic on that front? So what's your latest thinking on the contribution from those and additional efforts you're putting in the dermatology space? And then just on tavapadon in Parkinson's, how are you thinking about that product, how it will fit into the treatment paradigm within Parkinson's — mono versus combo — and then the overall opportunity for it. And if you'll put more resources within the Parkinson's franchise as well?

Thanks. It's Jeff. I would say that we have been very encouraged over the data that we've seen as these products have read out. And the first of the next wave of Rinvoq indications was giant cell arteritis, which was the smallest of the bunch. What we've observed has been quite interesting in the rheumatology community as we've started to highlight the benefits of Rinvoq for GCA, it actually has what I would call a spillover effect onto rheumatoid arthritis and psoriatic arthritis. So the rooms get more and more comfortable. So these indications, we believe, will build on top of each other. We still look at that $2 billion as a reasonable base case. But I would say we're leaning toward being more optimistic. One of them has to do with timing of vitiligo — this will be the first truly systemic drug for vitiligo. And we look at the data, and it seems to continue to build over time. Now this isn't like atopic dermatitis itch where you get an immediate symptom relief; patients need to be consistently taking the medication, but it continues to show meaningful repigmentation over time. So that's very positive. So the first in vitiligo I would say the other thing that surprised us is there are approved JAKs in alopecia and we've seen modest effort historically in that market, but the Rinvoq data, again, cross-study comparison suggests twice the effect in some measures. So I would say we're really leaning toward potential upside to that initial outlook, primarily driven by alopecia areata given the profound changes that we're seeing. And I would be remiss if I didn't say that we're also very excited to see how the ultimate readouts are in hidradenitis suppurativa (HS). We built the HS market. And so with HS, with the readout for Rinvoq, that's also another nice portfolio play for us. So they're meaningful opportunities that we have as we get closer to that.

And then to add, just to zoom out a little bit. Obviously, we're very excited about this next wave of indications and the impact they can have on the asset. When we look at overall Rinvoq expectations, at least for what sell-side consensus is modeling, we still see broadly upside on Rinvoq in each year with that number growing each year. So this will contribute to that. But I'd say the underlying performance of the approved indications also is very strong.

And to move to tavapadon, again, the idea is building these deep portfolios. Obviously, we have the small product with VY-ALEV which had earlier strong uptake and is continuing to progress towards blockbuster status. With the approval of tavapadon we can actually play with an innovative molecule and brand in the large oral market, which is about 85% of the Parkinson's market right now. And as you highlighted, it's attractive in both monotherapy settings as well as an add-on setting to the standard of care levodopa/carbidopa. Our physicians are reacting to the monotherapy side, particularly for patients that are younger. There are a significant number of younger patients where they could be on these oral medications for a decade or more, and they want to spare use of levodopa/carbidopa as long as possible. So that's very important. Adding on to control dyskinesia events and to spare progression toward dyskinesia is also something brought up by thought leaders. I would also say that the adverse event profile we've seen for tavapadon is markedly different than older agents. You see far less dyskinesia, less edema, low sedation, and lower rates of impulse control disorders. So we're very positive on this. We're looking forward to the launch here, and we've started to build out our team in Parkinson's, similar to how we've built for dermatology for those additional indications. So a nice catalyst that's coming here at the end of the year.

I'll just add that tavapadon complements our existing portfolio and gives us a very strong footing in Parkinson's. We think about neuroscience overall for the company — we are a market leader and expect to be a leader in the space for a long time. We see Parkinson's as a multi-billion-dollar franchise and expect it to be among our top franchises along with psychiatry and migraine.

On the call today, especially on the pipeline. So I have one, maybe following up on the comments you made around HS data coming later this year. So I was just curious if you could maybe just level that sort of expectation of what you're hoping to see from both readouts that we should get soon? And then the other one, ABBV-383 looks like it's moving a little faster than you thought potentially filing this year, obviously a pretty competitive space. Just curious if you can based on how things are evolving in that market where you see the differentiation for your product would be relative to a competitor?

It's Roopal. On HS, the 16-week data is what we anticipate for Rinvoq and lutikizumab and the way these are designed, they're slightly different. So lutikizumab will be enrolling patients that have already been on advanced therapies and treatment-naïve patients. And if you go back to the Phase II data, that was 100% TNF inhibitor inadequate responders and a very refractory patient population with quite severe HS, and we saw very strong data in that setting. We did conduct some data in naive patients, and that data looks even stronger. The issue in HS for all of us in drug development is control of the placebo rate. So for lutikizumab being in naive and failure populations, we will be utilizing a high Hidradenitis Suppurativa Clinical Response (HiSCR-75) threshold. And hopefully, that serves to reduce that placebo rate but then if that data looks good and the potential for approval, you would have an agent that could play in both areas of the market. And then secondly, on Rinvoq, that is going to be 100% biologic failure population. And because of that, that has the potential ability to control some of the placebo effects and we'll have a standardized HiSCR-50. So if both look good and are approved, you'll see a dynamic that's not dissimilar to what we have in IBD, where you have a frontline very powerful asset and then one that can come later on in case there's a loss of response like Rinvoq. And that's consistent with what we see with Crohn's and UC. And I think it will be beneficial to both assets, if approved. Regarding ABBV-383, we do see the crowded market, as you've stated, but the opportunity is still tremendous. And that opportunity exists if you have the right asset with the right profile. And what ABBV-383 brings is very substantial efficacy that we've seen, and that is, we think, associated with the strong binding to BCMA. It has a somewhat lower affinity for the T-cell side of things and the T-cell engagement, and that has set up what we believe to be a differentiated safety profile and we have a somewhat extended half-life. So what you could then see happening if we're successful is a singular priming or step-up dose and immediately going to the full dose; you would see very low CRS. And if that's the case, you have the potential for outpatient administration in community settings. That currently, the profile I just described doesn't exist. So entering a little bit later is okay if you're bringing the right profile. Recall, we've had success coming into markets later when the profile is differentiated, such as Skyrizi and Rinvoq. But we believe the profile is going to be the key driver of the potential uptake in the future.

First, Rob, just maybe for you in the context of the statements that you continue to see upside to consensus forecast for both Skyrizi and Rinvoq going out each year and that upside growing each year. Just curious as to how that triangulates with your calculus of no longer updating mid-term guidance for these products? And related, are there still areas of where you see meaningful disconnect versus consensus outside of those two products? And then maybe if I could squeeze one in for Roopal. Just on obesity, as you think about building a broader portfolio around ABBV-295, just what might that look like in the context of Rob's earlier comments on obesity as an area of potential corporate interest?

Okay. So, it's Rob. I'll take your first question. Recall, our previous long-term guidance really served a very specific purpose ahead of the HUMIRA loss of exclusivity. But I wouldn't rule out doing it again in the future if it made sense. That said, when I look at the current state of AbbVie's business, the long-term outlook and the pipeline is replacement power — we have never been in a stronger position. I mean we are the clear leader in immunology and neuroscience with a portfolio of assets that are demonstrating very significant growth, in many cases north of 20%. And both areas have a pipeline that can deliver transformational improvements over existing therapies. When I look at sell-side consensus, I mentioned, we do see upside. We see upside for the total company revenue in every year with that upside growing. I already mentioned that we expect to have upside versus the sell side on Skyrizi and Rinvoq. We expect to exceed the peak consensus that's in those models. I already mentioned in neuroscience that we see upside versus expectations for migraine and Parkinson's. Right now, what we see in consensus is peaking at below $4 billion; we've said several times, we expect them to each peak in excess of $5 billion. And then we look at our oncology pipeline assets. Roopal just highlighted Temab-A and ABBV-383. We believe both of these have significant multi-billion-dollar peak potential and both have really not even been described any value by roughly half of the sell-side. And so we will continue to highlight this in our commentary when we see the upside. Clearly, the previous long-term guidance was very granular — more than really anyone in the industry has ever provided — but we did it at a time where it was important to help understand what the company will look like on the other side of the HUMIRA loss of exclusivity. We're now in a very strong position. We can deliver top-tier growth for the long term, which puts us in a position of strength to continue investing in the business. I already mentioned our commentary around business development. We're very active in the BD area open to areas of differentiation within our core areas. And so we think the setup is very strong. And so I wouldn't rule out giving another long-term update at some point. But clearly, we have a lot of confidence in the outlook, and we'll provide updates as we see fit.

As you heard, the initial strategy is to drive as high of efficacy as we can, but clearly balance that with tolerability because that's what's going to drive ultimate durability. We've seen too many people fall off their current assets because of tolerability. So far, we see that shaping up nicely and notable weight loss in a nonobese population. So that opportunity still exists along with our ability to further increase dose, which we saw in the multiple ascending dose study. So that strategy will play out over the course of this year and next year before we start designing Phase IIs. But the key is to optimize that efficacy and tolerability to drive that durability so the patient can experience those benefits long term. That could be in an early patient population naive, but we understand many of those patients will be coming off of their current therapies. The other opportunities that we would be looking for externally are anything that can augment that weight loss but maintain tolerability. If we see that in a subcutaneous agent that's combinable, that would be very important, and an oral would be something that we could be interested in. Also any other assets that would allow the optimization of retaining muscle and having a majority of the weight loss come from fat. We still see there's an opportunity there. So there will be some other areas that we would be interested in. Other unique areas are in immunology and potential combinations with our own assets. There's a substantial amount of obesity in psoriasis today, and that's a setup and something that we are exploring now and also even higher rates of obesity in some other chronic diseases. So that could be a potential other combination. And recall, with our tremendous amount of experience and presence in the aesthetics channels for any type of asset that comes up, that sets us up very nicely and could have a very good go-to-market synergy because of that aesthetics channel.

I missed part of the call, so hopefully I'm not repeating something. But with respect to ABBV-295, the amylin analog, competitors have stated that the secret sauce in some molecules is dialing out calcitonin receptor activation. So can you please comment on ABBV-295 activation of amylin versus calcitonin? And also, if you could discuss its half-life because the press release suggested the potential for monthly dosing and just wanted to get clarity on the half-life and your level of confidence in monthly dosing.

It's Roopal. Again, I'll talk about that. So yes, we have a dual-agonist molecule; it signals through amylin and calcitonin receptors. At this stage, I don't think we know yet where the ultimate 'secret sauce' is relative to outcomes. As we stated, the weight loss was substantial in only 12 weeks in a mostly male population that had a BMI of around 29%. We anticipate in later stages of development, BMI will be in the range of 36 to 37 and more than 50% of the patient population would be women where some different dynamics occur. The safety profile looked very strong. The potential upside is a benefit to bone because of the calcitonin signaling. As we develop the molecule, we'll be able to obtain bone density data to monitor bone and to see and compare if there's less loss of bone and preservation of bone, that could be very important for women, especially as they get older. We know with rapid weight loss, you do see loss of bone density. So at this stage, we see this as a potential advantage because of the efficacy and tolerability that we've seen to date. The half-life is approximately 270 hours. And what we did observe is every-other-week and the potential for monthly dosing — the pharmacodynamic effect should also be considered along with half-life. We've seen examples of that. Skyrizi is a good example in psoriasis. The half-life is 28 days yet the pharmacodynamic effect lasts beyond that. So far, the pharmacodynamic effect with ABBV-295 does create the potential for once-a-month dosing, particularly in the maintenance setting, which would be really important from a tolerability and convenience standpoint.

Operator, we have time for one final question.

Rob, just to be clear, the sell-side consensus is $33 billion for the company in 2031. So are you saying there's upside to that? And Rinvoq is modeled at $16 billion in 2031 — are you saying there's upside to that? Would you care to add whether or not you think it's just marginally low or whether there is significant upside? And then secondly, during periods of past economic uncertainty, I think AbbVie has observed and stated that aesthetics businesses were fairly resilient. But this time, it seems to be different. So is my recollection correct? And if so, why is it different this time?

Steve, I'll take the first question. The numbers that you're quoting from are consistent with what we've seen in sell-side consensus. And yes — we do expect the peak potential for both Skyrizi and Rinvoq to exceed those estimates. Obviously, the sell-side doesn't go out much further than that, and we think they have more runway. So we do think there's significant runway and upside opportunity for both assets.

Yes. And Steve, you're remembering correctly — several years ago, we referred to some recessionary dynamics around the Great Recession when we saw some compression and then a more rapid response to robust growth. But this time, we've seen more lingering inflationary dynamics that we haven't seen for decades. I think we're seeing relative stability in the markets now. On aesthetics, we are seeing low single-digit growth for toxins and still some decline for fillers. I do think it's a somewhat different cycle of pressure on the consumer. But you're correct in terms of what we had said previously with different types of recessionary issues. The category continues to have attractive long-term demand given low penetration in many markets, but there are short-term headwinds currently.

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