管理層發言
Good morning, and thank you for standing by. Welcome to the AbbVie Second Quarter 2026 Earnings Conference Call. All participants will be able to listen only until the question-and-answer portion of this call. You may ask a question by pressing star 1 on your phone. 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.
Good morning, and thanks for joining us. Also on the call with me today are Robert A. 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 T. Reents, Executive Vice President, Chief Financial Officer. Before we get started, I will 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 the earnings release and regulatory filings from today, which can be found on our website. Following our prepared remarks, we will take your questions. So with that, I will turn the call over to Robert.
Thank you, Liz. Good morning, everyone, and thank you for joining us. AbbVie delivered another excellent quarter, with results once again exceeding our expectations. I am especially pleased with the execution across our business, including double-digit sales growth from our diverse portfolio, the advancement of our compelling pipeline of innovative medicines, and our planned acquisition of Apogee Therapeutics, which represents an exciting opportunity to bolster AbbVie's leading immunology portfolio. Turning to our second quarter performance, we achieved adjusted earnings per share of $3.65, which is $0.06 above our guidance midpoint. Total net revenues were nearly $17 billion, beating our expectations by $300 million and reflecting robust sales growth of 10.2%. The performance of SKYRIZI, RINVOQ, and our neuroscience portfolio continues to be very strong, with each delivering growth above 20%. Based on this momentum, we are raising our full year revenue guidance by $300 million. We have now raised total revenue guidance by $600 million since the start of the year. Turning now to R&D, we continue to make excellent progress advancing our pipeline. Recent highlights from our late-stage programs include the U.S. approval of DecNUPAS, a treatment for a rare form of blood cancer. This represents AbbVie's first ADC in hematology. We also received European approvals for QLIPTA to treat acute migraine, Epkinly for second-line follicular lymphoma, as well as Bowie, a first-in-class short-acting toxin in aesthetics. In addition, we received European approvals for RINVOQ in both vitiligo and alopecia areata, with U.S. regulatory decisions forthcoming. Based on the compelling data generated for each of these programs, we now anticipate the combined peak sales for these two dermatology indications alone to approach $2 billion, which is meaningfully above our prior expectations. During the quarter, we also announced the acquisition of Apogee Therapeutics, which will add multiple differentiated assets in dermatology, respiratory, and other related inflammatory diseases with significant sales potential. The acquisition will add even more depth to our robust pipeline in immunology, which we expect will be a major growth driver for AbbVie over the long term. This transaction is an excellent fit with our strategy to build and advance a compelling pipeline with new sources of growth to support AbbVie's performance in the 2030s and beyond. We have ample financial capacity for more business development and remain focused on adding both early- and late-stage opportunities across our core disease areas. In summary, we are delivering outstanding execution across our business, and our long-term outlook remains very strong. With that, I will turn the call over to Jeff for additional comments on our commercial highlights.
Thank you, Robert. I will start with the quarterly results for immunology, which delivered total revenues of nearly $8.8 billion, reflecting very strong operational sales growth of 14.6%. SKYRIZI total sales were $5.5 billion, up 24% on an operational basis, once again exceeding our expectations. I am very pleased with our performance in psoriasis where we continue to capture robust in-play share of new and switching patients at a rate which is impressively four times higher than any other biologic or oral treatment in the U.S. We have achieved market share leadership now in more than 30 countries and see substantial room for continued growth globally. We do not expect a material impact to our robust outlook in psoriasis from existing or new therapies, given SKYRIZI's very distinct profile. This includes high and very durable skin clearance from head to toe, widely demonstrated superior efficacy in head-to-head trials versus five different mechanisms, including both biologics and oral agents; simple and convenient quarterly dosing; and extremely strong long-term data in psoriatic arthritis extending now to five years, which is very important to prescribers as roughly 30 percent of psoriasis patients ultimately develop PsA. We also recently received approval for pediatric use with a new weight-based dosing option. In IBD, SKYRIZI is the fastest-growing indication. We continue to capture a leading share of total new patient starts in the U.S. in the quarter, including substantial leadership in the frontline setting, the clearest signal of physician preference. Competitive dynamics remain in line with our expectations, with the IBD category seeing very robust growth in both Crohn's disease and ulcerative colitis. Importantly, we are also preparing for the potential approval of our subcutaneous induction dosing option for Crohn's later this fall, which is supported by very strong data, particularly in the frontline, where we observe the highest levels of endoscopic response seen in the category. Turning now to RINVOQ, which is also performing above our expectations. Global sales were more than $2.5 billion, up 23.7% on an operational basis. I am especially pleased with the momentum we see in gastroenterology, where RINVOQ is on pace to deliver 30% global sales growth this year. RINVOQ has set a very high bar for efficacy in both ulcerative colitis and Crohn's disease, demonstrating strong rates of remission and endoscopic improvement, and we continue to see a nice inflection of in-play patient share following the recently expanded label supporting access to RINVOQ earlier in the treatment paradigm for IBD patients. More broadly, we continue to see strong demand across all of RINVOQ's indications, and we are very excited about the growth potential in dermatology, with vitiligo and alopecia areata now approved in Europe and U.S. approval decisions anticipated over the next few quarters. RINVOQ's profile is competitively positioned for both of these chronic diseases where our recently expanded U.S. dermatology field force will support both launches. Lastly in immunology, HUMIRA global sales were $706 million, down 36.1% on an operational basis, reflecting biosimilar competition and in line with our expectations. Moving to neuroscience where we once again outperformed our expectations. Total revenues were more than $3.2 billion, up approximately 20% on an operational basis. All three of our leading neuro pillars continue to demonstrate robust sales growth. In psychiatry, Vraylar global sales were nearly $1.1 billion, up approximately 19%, reflecting share gains in both bipolar disorder and adjunctive MDD. In migraine, our leading portfolio continues to deliver outstanding results with Botox Therapeutic, Ubrelvy, and QLIPTA each delivering double-digit sales growth again this quarter. QLIPTA is now approved in Europe for adults as both an acute treatment for migraine attacks and as a once-daily preventive treatment option for chronic or episodic migraine. The acute indication expansion in international markets for QLIPTA further supports our long-term outlook for our oral CGRPs to collectively achieve more than $5 billion of peak sales. Moving to Parkinson's disease, another substantial long-term growth driver for AbbVie. Total sales for Vialev were $256 million, up more than 27% on a sequential basis. Vialev is well on track to achieve blockbuster sales this year, and we expect continued robust momentum in Parkinson's with the anticipated U.S. approval and launch of tevapadon in the third quarter. Feedback from key opinion leaders has been very positive, with tevapadon demonstrating strong efficacy as both a monotherapy as well as an add-on to standard of care. Overall, we believe our Parkinson's portfolio with Vialev, tevapadon, and Duopa will be a substantial commercial opportunity. We continue to expect collective Parkinson's peak sales of more than $5 billion. Turning now to oncology, where total revenues were more than $1.6 billion, down 2.4% on an operational basis. Total VENCLEXTA sales were $771 million, up 9.6% on an operational basis. Performance in CLL continues to be strong as VENCLEXTA used in combination with BTK inhibitors is expanding as a preferred fixed-duration treatment globally. Double-digit sales growth from Elahere, Epkinly, and Amrelis also helped to partially offset the sales decline for IMBRUVICA, which was down 29.4% as expected due to pricing and competitive share pressure. We also launched DecNUPAS, a new therapeutic option for patients living with BPDCN, an ultra-rare form of blood cancer, further expanding AbbVie's emerging ADC portfolio. Moving now to aesthetics, which delivered sales of nearly $1.3 billion, down 0.9% on an operational basis. Botox Cosmetic total revenues were $728 million, up 3.4% operationally reflecting modest market growth globally. Juvederm global sales were $245 million, down 6.6% operationally reflecting continued headwinds in key dermal filler markets. As the industry leader, we continue to invest in this highly underpenetrated market to support long-term growth. I am especially pleased with the recent Europe and Canada approvals of Bowie, our fast-acting short-duration toxin. Bowie complements our toxin portfolio very nicely and represents a new way for patients to initiate an aesthetic treatment. We expect Bowie will meaningfully expand the toxin market and look forward to potentially bringing this exciting innovation to the U.S. Overall, we continue to demonstrate outstanding commercial execution. And with that, I will turn the call over to Roopal for comments on our R&D highlights.
Thank you, Jeff. I will begin with dermatology programs in immunology. RINVOQ was approved in Europe for the treatment of severe alopecia areata and non-segmental vitiligo. Applications are also under review in the U.S., with approval decisions anticipated later this year for vitiligo and early next year for alopecia areata. In hidradenitis suppurativa, we remain on track for 16-week data later this year from both RINVOQ and lutikizumab Phase III trials. In our early-stage dermatology pipeline, three programs were recently advanced into the clinic, including an IL-13/IL-31 receptor bispecific antibody for atopic dermatitis, an oral IL-23 receptor inhibitor for psoriasis, and a long-acting IL-1 alpha/beta bispecific antibody for hidradenitis suppurativa. Turning to gastroenterology, the U.S. application for SKYRIZI subcutaneous induction in Crohn's disease is under review, with an approval decision expected later this fall. The subcutaneous regimen demonstrated very high levels of endoscopic response and clinical remission, with rates on both measures 25 points higher than placebo in the overall population and 45 points higher in patients who had not previously experienced advanced therapy. To our knowledge, these results in patients naive to advanced therapies are the highest reported for induction therapies in Crohn's disease, comparing very favorably to SKYRIZI IV and other approved agents. Full results from the study will be presented this fall, which will include additional important endpoints such as endoscopic remission. Start-up activities are underway for our Phase 2b combination trial in IBD. This multi-arm study will evaluate SKYRIZI plus a higher dose of our novel anti-alpha4beta7 antibody and extended half-life TL1A antibody in both Crohn's disease and ulcerative colitis. Interim results for SKYRIZI plus anti-alpha4beta7 in Crohn's disease demonstrated a doubling of endoscopic remission at week 24 compared to either monotherapy. This study is expected to complete this fall and final results will be submitted for presentation at a future medical meeting. And lastly, in immunology, we announced the planned acquisition of Apogee Therapeutics, which adds a portfolio of long-acting biologics targeting atopic dermatitis, respiratory conditions, and other immune-mediated diseases. These novel assets are highly complementary to our immunology strategy and further strengthen an already robust pipeline. Moving to neuroscience, QLIPTA was approved in Europe for the acute treatment of migraine, expanding options for patients. In Parkinson's disease, an FDA approval decision is expected in the third quarter for tevapadon. Results from three Phase III trials demonstrated that this novel selective D1/D5 dopamine agonist has the potential to be a highly effective treatment for motor symptoms with low rates of dyskinesia, edema, sedation, and impulse control disorder. We look forward to bringing this innovation to patients later this year. In our early-stage neuroscience pipeline, multiple new trials were recently initiated, including a Phase II study for a novel toxin, Trenibot, in essential tremor, and a Phase 1b study for a blood-brain barrier crossing anti-pyroglutamate Aβ antibody, BBB-1.76, in Alzheimer's disease. In schizophrenia, the multi-ascending dose study for bretasilocin is nearing completion. The 100-milligram dose retained a safe and tolerable profile and now 150 milligrams is being evaluated. Dose selection for both schizophrenia and psychosis programs is expected in the coming months, and we remain on track to begin Phase II studies in the fourth quarter. Moving to solid tumor programs, progress with TMAbA continues across a broad range of tumor types. In colorectal cancer, breakthrough therapy designation was granted for TMAbA in combination with bevacizumab in refractory metastatic CRC. This designation supports our Phase III strategy in an all-comer third-line-plus setting and the trial is now actively recruiting. In second-line CRC, data are expected later this year from a Phase II study evaluating TMAbA combinations versus chemotherapy. These results will help inform the development strategy for TMAbA in first- and second-line CRC as an irinotecan replacement. Early-stage results in ovarian and head and neck were presented at the recent ASCO meeting demonstrating TMAbA's potential in both tumor types. In platinum-resistant ovarian cancer, TMAbA showed strong antitumor activity, particularly in c-MET selected patients where response rates reached as high as 80%. TMAbA also demonstrated a 50% response rate in clear cell carcinoma, a segment with high unmet need that typically does not respond well to cytotoxic therapy. Plans to advance TMAbA in ovarian cancer will be discussed with regulators over the coming months. In c-MET selected patients with advanced head and neck cancer, TMAbA demonstrated a 31% response rate and a median overall survival of 15.3 months, which compares favorably to standard of care. A Phase II study evaluating TMAbA plus pembrolizumab in frontline will start soon. In pancreatic cancer, a Phase II study evaluating TMAbA with FOLFOX as a frontline combination therapy was recently initiated. Turning to hematologic oncology, progress continues with etansamig across lines of therapy in multiple myeloma. An interim analysis is planned in the third quarter for progression-free survival from the monotherapy Third-Line-Plus trial. If this interim analysis is positive, regulatory submission would occur later this year. A Phase III study evaluating etansamig in combination with pomalidomide in second-line-plus patients, including those that were exposed or refractory to an anti-CD38 antibody, or who lost response to an anti-BCMA CAR T or ADC, will begin by year end. Additionally, encouraging early-stage results for etansamig in relapsed/refractory light-chain amyloidosis were presented at the recent EHA Congress. At the 40-milligram dose, 100% of patients achieved hematologic complete response with a promising safety profile that included no CRS or ICANS. Based on these results, a Phase III trial in newly diagnosed patients is being planned. Also in hematology, DecNUPAS received FDA approval for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare and aggressive blood cancer. As a new treatment alternative providing durable responses with a manageable safety profile and outpatient administration, DecNUPAS offers a meaningful benefit to patients with this rare cancer. Moving to aesthetics, our rapid-onset and short-duration toxin Bowie was approved in Europe and Canada for the temporary improvement in the appearance of glabellar lines. This marks an important milestone in aesthetic medicine. Bowie was developed to allow patients to temporarily preview the benefits of cosmetic toxins without worrying about long-lasting results. Clinicians and patients now have another option to tailor treatment to individual needs and goals. In summary, we are making meaningful progress with our pipeline and look forward to additional important data readouts, regulatory submissions, and approvals throughout the remainder of 2026. With that, I will turn the call over to Scott.
Thank you, Roopal. Starting with our second quarter results, we reported adjusted earnings per share of $3.65, which is $0.06 above our guidance midpoint. These results include a $0.17 unfavorable impact from acquired IPR&D expense. Quarterly net revenues were nearly $17 billion, reflecting robust growth of 10.2% including a 0.7% favorable impact from foreign exchange. Adjusted gross margin was 84.7% of sales. Adjusted R&D expense was 13.6% of sales and adjusted SG&A expense was 21.0% of sales. The adjusted operating margin was 48.3% of sales which includes a 1.7% unfavorable impact from acquired IPR&D expense. Net interest expense was $679 million. The adjusted tax rate was 14.7%. Turning to our financial outlook, we are updating our full year adjusted earnings per share guidance to between $13.87 and $14.07. This update reflects a $0.10 improvement in the outlook of our existing business based on strong second quarter results and continued momentum. It also now includes $0.14 of anticipated dilution related to the planned Apogee acquisition that is more than offsetting our underlying overperformance. We continue to expect that the Apogee transaction will close in the third quarter. 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 $67.6 billion, an increase of $300 million. This assumes a roughly 0.5% favorable impact from foreign exchange on full year sales growth, reflecting less benefit than our previous expectation. Our increased revenue forecast includes the following approximate assumptions for several of our key products and therapeutic areas. We now expect SKYRIZI global revenues of $21.7 billion, an increase of $100 million based on momentum across psoriatic and IBD indications. Total neuroscience revenues of $12.7 billion, an increase of $100 million now reflecting Vraylar sales approaching $4.1 billion and Botox Therapeutic sales approaching $4.2 billion. The remaining $100 million increase reflects momentum from RINVOQ and VENCLEXTA. Moving to the P&L for 2026, we continue to forecast full year adjusted gross margin above 84% of sales. We now expect adjusted R&D expense of approximately $9.8 billion, an increase of $100 million reflecting Apogee-related pipeline investments. We expect adjusted SG&A expense of approximately $14.5 billion as we continue to support our significant commercial momentum. We anticipate an adjusted operating margin ratio approaching 47% of sales. We also expect adjusted net interest expense of approximately $2.9 billion, an increase of $200 million, which reflects the partial-year financing cost of the planned Apogee transaction. Finally, we now forecast our non-GAAP tax rate to be approximately 14.5%, which reflects the impact of acquired IPR&D. Turning to the third quarter, we anticipate net revenues of approximately $17.2 billion, which includes an estimated 0.4% unfavorable impact from foreign exchange. We also forecast adjusted earnings per share between $3.84 and $3.88. This guidance contemplates a partial quarter of dilution related to the planned Apogee transaction but does not include acquired IPR&D expense that may be incurred in the quarter. Finally, AbbVie is financially well-positioned to complete the planned Apogee acquisition. We have secured interim financing and expect to issue long-term debt in the coming months. We remain committed to achieving a net leverage ratio of two times within two to three years following the deal close. Importantly, based on our strong cash flows, balance sheet and business outlook, we continue to have substantial financial flexibility to pursue additional innovative business development. In closing, AbbVie continues to deliver outstanding performance and we are carrying significant momentum into the second half of 2026. With that, I will 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, we will take the first question.
分析師問答
Thank you. And as a reminder, that is star 1 if you have a question. We will go first to Terrence Flynn with Morgan Stanley.
Great. Congrats on all the progress. Maybe a two-part for me on SKYRIZI. I know you have the FDA action on the subcutaneous formulation for induction coming up this fall. Maybe, Roopal, you could just speak to your confidence in that approval? Is everything on manufacturing lined up? Just want to make sure there are no issues there. And then on SKYRIZI plus alpha4beta7, some very exciting data. Looking forward to seeing that. Can you confirm yet if that will be at the UEGW conference in the fall? Thank you.
Thanks, Terrence. It is Roopal. So on the Crohn's disease subcutaneous SKYRIZI, as I highlighted, very strong data. It is SKYRIZI, so it is an asset well known to health authorities, and manufacturing is very well known to us. We have a very complete submission that is in front of the agency, and so far that review is going according to plan. So no concerns at this moment. And then on the alpha4beta7 combo data, I did not specifically call out a meeting because of the timing. What we provided earlier was interim data. As the rest of it comes in, we would obviously try for later this fall, and if we are unable to get into that window, then it would go into next year's congresses. So either way, we are very excited to show more of that data. It could be in the fall, and if not possible, we will see it next year. Thanks, Terrence.
Operator, next question, please.
Yes, ma'am. We will go next to Carter Lewis Gould with Cantor Fitzgerald.
Great. Good morning. Thanks for taking the question. A follow-up, Roopal. The Phase II that you have talked about starting with the alpha4beta7, it is a bit of a beast—2,000 patients across a number of settings. Can we just set the stage there? In the past, you have talked about the speed, not waiting potentially for the full Phase III data or Phase II data before moving to Phase III. Is that still in the cards? And in that study, it also talks about ABBV-66 with SKYRIZI and trocinolumab. Is that a co-formulation or just a co-administration? Thank you.
Yes, thanks for the question. It is a large study. It is a platform study similar to what we have run before. SKYRIZI is the anchor asset. We will be combining TROSU, the alpha4beta7, at an even higher dose than we studied previously. We are in parallel working on co-formulation, so the intent at launch for any of these assets in combination with SKYRIZI in IBD would be a co-formulation. So that data would be collected in Crohn's and ulcerative colitis in combination with SKYRIZI. The scale of that study also reflects that the TL1A program is in that trial as well combined with SKYRIZI in Crohn's disease and ulcerative colitis. Enrollment should be starting any moment and the trial is ready to go. Regarding when we can start seeing data, we do not have an intention to wait until the end. We will take a couple of interim snapshots and if we see, for example, the higher dose of TROSU or the alpha4beta7 agent supporting higher efficacy, then we would start making plans to move into Phase III with that combination. The same goes for the TL1A. If we start seeing really strong data, we would start moving quickly into Phase III. We would anticipate right now, hopefully in the first half of 2028 being able to kick off Phase III programs in IBD.
Thanks, Carter. Operator, next question, please.
Yes, ma'am. We will go next to Christopher Schott with JPMorgan.
Great. Thanks so much for the questions. Can I just come back to SKYRIZI in psoriasis? I know you just made some comments in terms of the launch of ICO and the impact or just lack of impact that it has had there. Can you elaborate a bit more on what you are seeing in terms of dynamics in psoriasis and how much more growth opportunity there is for SKYRIZI in this setting given the higher penetration rates? And then a quick second question: looking ahead to the upcoming readouts for lutikizumab and RINVOQ in HS, talk about your relative confidence in those two assets and the role you see each playing in the market there?
Hi, it's Jeff. I'll take the first question. As I mentioned, SKYRIZI's profile is very, very strong. The skin clearance, joint protection, safety, and convenience make it a unique product, and that is why we have such a high capture rate. We see a couple of things in the market. First, since the launch of ICO, the vast majority of ICO share that we see is being sourced from the two other orals in the marketplace, which is similar to what we had expected. Second, when we look at our MBRx data in the dermatology and psoriasis market—this includes new starts as well as switching starts—we have seen no degradation in any of our MBRx trends since the launch of ICO; in fact, they have grown since ICO launched in March. There is still significant headroom in the moderate-to-severe psoriasis space: a large percentage of patients in the U.S. and globally are still not on an advanced therapy. We, of course, factor competitive dynamics into our models and will continue to monitor, but we are quite pleased with SKYRIZI momentum and believe it will continue given the robustness of the marketplace. Robert, do you want to add?
Chris, I'll just add that we always viewed this as a market-expanding competitive launch, and that is exactly how we are seeing it. We've made disease awareness investments and are seeing very nice momentum continue. Jeff highlighted that we are actually seeing an acceleration of NBRx growth for SKYRIZI since the launch of ICO, which further supports our view that this is more of a market-expanding opportunity.
Hi Christopher, regarding hidradenitis suppurativa. We have observed other failures in the space over the years and designed two very robust studies; enrollment has gone very well. Training and patient selection are very important to ensure we're picking up moderate and severe disease. In terms of differences between lutikizumab and RINVOQ, lutikizumab studies are enrolling patients who are naive to advanced therapies as well as those who had failed prior therapies such as anti-TNFs, and the primary endpoint there is HiSCR75, which is a more stringent endpoint while including more naive patients. The RINVOQ design is in the post-biologic population, for example post-HUMIRA, and it has a HiSCR50 primary endpoint with secondary endpoints that will look at HiSCR75. These design choices reflect how we will position these agents commercially: lutikizumab, based on its robust safety profile and strong Phase II efficacy, could be used in earlier lines of patients, while RINVOQ has historically worked well as a later-line option after advanced therapy. Based on those designs, we'd expect to see a market profile similar to what we've executed in IBD.
Thanks, Christopher. Operator, next question, please.
Yes, ma'am. We will go next to Michael Yee with UBS.
Thank you. Maybe just pivoting away from immunology for one second. Can you talk a little bit about your expectations on the tevapadon launch? Ultimately, how do you see this playing out and what could be a slow start or fast start? Maybe also talk about how you think about the brain shuttle asset and how it is differentiated, given interest in Alzheimer’s. Thank you.
Thanks for the question. I'm glad you brought up tevapadon because it is a key piece of our overall long-term strategy for growth in Parkinson's. Tevapadon is a very unique product—the first selective D1/D5 agonist. We will have both a monotherapy indication as well as an add-on to levodopa-carbidopa. Results have been remarkable. One impressive dynamic is that after 85 weeks of long-term utilization of tevapadon, more than 90 percent of patients did not need to increase their dose of levodopa-carbidopa—essentially it stabilizes motor dysfunction and can help spare dyskinesia, which is critical. The other distinctive aspect is the low rates of sedation (so-called sleep attacks), low rates of edema, and very low incidence of impulse control disorder. That efficacy and safety profile is quite attractive. Regarding launch dynamics, we do expect the initial ramp to be modest, not because of the profile but due to timing of approval and formulary access—particularly Medicare coverage—which will take time to negotiate. Nonetheless, we believe tevapadon will be a substantial addition to the marketplace and a clear contributor to the greater-than-$5 billion peak potential we discussed.
Michael, regarding the BBB-1.76 asset, it has now entered Phase 1b. The molecule was built to have an extended half-life and we have observed that in first-in-human pharmacokinetic data. We also wanted better cerebrospinal fluid penetration than we saw with a naked antibody, which is typically around 0.1% to 0.2% of plasma; BBB-1.76 has shown over 1% CSF penetration, several-fold higher. So the transport is working. If we can get more into the CSF and have an extended half-life, and if we can take down plaque—this specifically targets pyroglutamated Aβ, which we think is a more toxic species—this could set up the potential for a subcutaneous agent that could be dosed monthly, improving patient convenience. By next year, we should start seeing imaging data to see if we can clear the brain, and if we see that, we would move quickly. In parallel, we are working on anti-tau approaches using siRNA with the same shuttle technology; intrathecal approaches have challenges and if we can deliver siRNA systemically using shuttle technology, that could be another advantage. Ultimately, Alzheimer's will likely require a combination approach and AbbVie is well positioned to pursue that.
Thank you, Michael. Operator, next question, please.
Yes, ma'am. We will go next to Mohit Bansal with Wells Fargo.
So I want to come back to HS. The biggest debate you hear from KOLs is whether IL-1 is simply another inflammatory mechanism or could it become meaningfully superior to IL-17 and other agents. What evidence do you have today that gives you confidence that lutikizumab could break through the efficacy ceiling there? And the second part: how are you managing GLP-1 baseline use in your clinical trials, because that could contribute to high placebo rates? Thank you.
Thanks, Mohit. Regarding efficacy comparisons and benefit-risk, in the Phase II study with lutikizumab we saw very strong data with high deltas that would position it favorably against anti-TNFs and anti-IL-17s. We have not seen fungal infections or flares in IBD, so we believe that creates a strong benefit-risk balance. We also expect RINVOQ to have a role. Regarding GLP-1 use, the trial is quite large so if GLP-1 use occurs it should be balanced across both arms; if weight loss driven by GLP-1s increases placebo responses, we would anticipate a similar effect in the active arm. Most of these studies started before the most recent uptick in GLP-1 usage. Weight loss is a potential driver of inflammation and pain in HS and combining our obesity assets—such as ABBV-295, an amylin receptor agonist—with lutikizumab is an approach under consideration. We are thinking about combinations across our franchises and will continue to monitor these dynamics closely.
Thanks, Mohit. Operator, next question please.
Yes. We will go next to Asad Haider with Goldman Sachs.
Great. Thanks for taking the question and congrats on the quarter. Maybe we can talk about oncology. Robert, you've said in the past that oncology doesn't get enough attention. Maybe a question on the broader oncology strategy and your key programs in the context of a rapidly evolving landscape where both ADCs and PD-1/VEGF programs are in focus. First, what will we learn about TMAbA in the upcoming readouts and where do you see this ADC differentiating from others? And related, on the PD-1/VEGF compound that you licensed from RemGen, I think Roopal said there will be some data at World Lung in a couple of months and that you are considering accelerating that program into Phase III with chemo combos and ADC combos. Any preview of what we can expect at World Lung and on your overall development strategy? Thank you.
Thanks, Asad. Regarding our ADC portfolio, we've moved quickly: Elahere, Amrelis, and now DecNUPAS are on the market. Amrelis is already positioned in c-MET-positive second-line lung and physicians are gaining experience. In terms of differentiation, TMAbA is progressing rapidly: we are well into a Phase III in combination with bevacizumab in third-line CRC and the Phase II second-line CRC data are expected later this year. In Phase II, in the third-line setting TMAbA plus bevacizumab delivered a 30% response rate compared to zero percent with standard of care in that cohort, which is notable. If we see strong data in second-line versus irinotecan, we could replace irinotecan and move TMAbA into first- and second-line settings, which are large markets. As we move into earlier lines we'll evaluate c-MET expression; c-MET tends to be higher in later lines but if we can develop a biomarker-directed approach that would be another way to differentiate and individualize care. We are also studying TMAbA in head and neck and ovarian and can move into Phase III if data are supportive. Regarding PD-1/VEGF from RemGen, you will see data at World Lung demonstrating response rates and PFS in lung, and we anticipate a very competitive profile in terms of efficacy and tolerability. If dosing is optimized and we can align with regulators, we can move rapidly into Phase III as a chemo combination, and in parallel start testing ADCs in combination with PD-1/VEGF across tumor types, including lung and ovarian. I will also note other oncology programs: 706 and CEDS6 (an ADC) has shown strong data in small cell lung cancer and is in Phase III, and our PSMA bispecific 969 showed strong data at ASCO and is positioned to start moving into Phase III in prostate cancer, without the logistical challenges of radioligand therapy. We are very excited about the depth and breadth of our oncology portfolio.
Thanks, Asad. Operator, next question, please.
We will go next to David Amsellem with Piper Sandler.
Thanks. In light of your comments on RINVOQ in alopecia areata and vitiligo, particularly regarding vitiligo, how do you square your expectations in terms of peak with an increasingly crowded development landscape inclusive of other agents like IL-22s? And then switching gears to bretasilocin and the psychedelics/neuroplasticins space: how are you thinking about positioning that agent given what we've seen recently in MDD data from other companies? Thank you.
I'll take the vitiligo question. These immunology markets are remarkably resilient and expansive once effective systemic therapies become available. For vitiligo, there are currently no systemic treatments approved, so being first is a major advantage, especially for patients with higher body surface area involvement where topicals are impractical. The efficacy we observe, particularly over longer-term extensions where benefit accrues over time, supports our confidence in the market opportunity. We are already expanding the RINVOQ field force to support launches across indications and believe our long-term safety database and multi-indication strategy (atopic dermatitis, alopecia areata, vitiligo) position RINVOQ strongly to lead the emergence of these markets.
David, on vitiligo and alopecia areata, the head start is very beneficial and we do not yet know how competing assets will play out in terms of longer-term safety and efficacy. RINVOQ is well characterized with over a decade of safety data and familiarity already exists in atopic dermatitis and other dermatology settings. We also anticipate improvements in efficacy over time. On bretasilocin, there are several areas of differentiation. First, the short duration of the clinic experience—most patients are ready to leave the clinic within two hours. Second, the subjective experience is often described as visual and rich rather than intensely distressing; some other agents in development have had reports of unpleasant or disorienting experiences and even loss of consciousness in some cases, which we have not observed with bretasilocin. Third, bretasilocin is an antagonist at 5-HT2B whereas others are agonists at that receptor; 5-HT2B agonism is associated with cardiovascular valvulopathy and related risks. We do not see those safety concerns, which could support chronic or repeat use. We are studying bretasilocin in MDD and considering PTSD and other indications. These differentiating attributes—short duration, tolerability, and receptor pharmacology—are why we like this asset.
Thanks, David. Operator, next question, please.
Yes. We will go next to Luisa Hector with Berenberg.
Hello. Thank you for taking my question. Can you give any early indication from formulary season? I hear levels of confidence around SKYRIZI and RINVOQ. Any color on pricing environment and impact from head-to-heads from competitors? And then a quick check post the Apogee announcement: did you deprioritize any of your own pipeline assets in atopic dermatitis around that time in connection with Apogee? Thank you.
Thanks for the question. Regarding payer negotiations, contracting season typically starts in the early spring and this year seems no different. These negotiations are always tough, but overall we see dynamics consistent with prior years. Immunology is a volume-driven business and we typically see low single-digit concessions around rebates and price concessions, which we factor into our plans. Our position is strong and we are encouraged about how things are shaping up, though negotiations are ongoing.
Luisa, on head-to-heads versus SKYRIZI, over time the data gap tends to close, and clinicians value SKYRIZI's safety profile and quarterly dosing, so we expect continued strong demand. On our atopic dermatitis assets, we are running all of them in parallel and moving as quickly as we can. We want to advance the anti-IL-13 program as quickly as possible, and we are in the clinic with our IL-31 bispecific and expect to soon be in the clinic with an IL-13/IL-18 bispecific for atopic dermatitis and potentially asthma. Apogee brings an anti-IL-31 asset and other complementary programs; we expect to test those in combination or in ways that augment our portfolio. All of these assets are being designed to be long-acting, which could deliver convenience to patients if the efficacy is met.
Thanks, Luisa. Operator, next question please.
We will go next to Matthew Phipps with William Blair.
I want to ask about ABBV-859, the oral IL-23 receptor inhibitor. You talked a little about ICO coming into the market. How do you see the differentiation for ABBV-859 and maybe how you will position it across other indications? Thank you.
Thanks, Matthew. What we liked preclinically about ABBV-859 was its potency. If that plays out clinically, it could allow a higher dose to achieve much better target coverage. SKYRIZI provides deep coverage and high responses; for an oral to approach that, potency and tolerated higher dosing matter. Another design element is half-life: many orals have short half-lives and Cmin troughs can lead to loss of efficacy. ABBV-859 was designed for an extended half-life, and we will start seeing that data next year to determine if we can achieve extended duration—potentially enabling less than daily dosing such as once-weekly dosing if the PK and exposure support it. Those features could drive higher efficacy and better coverage, and we will learn more as human data are generated imminently.
Thanks, Matthew. Operator, next question, please.
Thank you. We will go next to Louise Chen with Scotiabank.
Hi. Thanks for taking my question. I wanted to ask about SKYRIZI subcutaneous: if it's approved in the fall, do you expect that to drive an acceleration of sales in the second half of the year for SKYRIZI? And then on the runway for exclusivity for SKYRIZI beyond 2033, any update there?
Thanks for the question. Yes, we do expect meaningful acceleration for SKYRIZI with the availability of a subcutaneous induction option. The main market value drivers in IBD are efficacy on stringent endpoints like endoscopic response and endoscopic healing; the subcutaneous induction connects several of those drivers—it demonstrated very strong efficacy and creates convenience by enabling some physicians to avoid working across two reimbursement channels (medical and pharmacy). That will help adoption alongside our strong maintenance convenience. We plan for an acceleration of our capture rate. However, it will take a few months to fully ramp availability based on contracting and formulary processes, so the material acceleration may be more evident in early 2027, though we'll begin communicating the innovation in Q4.
Louise, on the SKYRIZI intellectual property: SKYRIZI's composition-of-matter patent expires in 2033 as you noted, and we do have later-expiring IP granted and in process that embodies SKYRIZI's innovation, including patents expiring in the mid-2030s and later. Importantly, 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. We have a strong track record of vigorously defending our patents and protecting our innovation and expect to continue to do so.
Thanks, Louise. Operator, we have time for one final question.
Yes, ma'am. We will go next to Evan Sigerman with BMO Capital Markets.
Hi, I'm Malcolm Hoffman on for Evan. Thanks for taking our question. For bretasilocin, you said 100 milligrams is safe and tolerable with further escalation plans. Can you speak to why you are confident that increased dosing could translate into improved efficacy above what we've previously seen? Are you looking at receptor occupancy data? Just trying to get a sense of confidence here. Thanks.
Hi, it's Roopal. Yes, 100 milligrams is looking good and that will be the lowest dose we would take forward. Next is 150 milligrams. Receptor occupancy is a key part of our rationale. In prior datasets the observed receptor occupancy was lower than we'd have liked, so by increasing dose we anticipate achieving much higher receptor occupancy. We've also observed PK variability; a higher dose should improve consistent PK across dosing and over time, increasing occupancy and potential efficacy. We continue to like the safety profile and are not seeing the GI adverse events that can be problematic in psychiatric populations. Phase II is kicking off later this week and we'll learn more as we escalate dosing and read out biomarker and clinical signals.
Thanks, Malcolm. That concludes today's conference call. If you would like to listen to a replay of the call, please visit our website at investors.abbvie.com. Thanks again for joining us.
This does conclude today's call. Thank you for your participation. You may now disconnect.