Operator. Good morning, and thank you for standing by. Welcome to the AbbVie Second Quarter 26 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. Elizabeth Shea. 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 risk 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 and are 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. Robert A. Michael. 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. And have now raised total revenue 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 US approval of Decnapaz, 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 US regulatory decisions forthcoming. Based on the compelling data generated for each of these programs, we now anticipate the combined peak sales for these 2 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 20 thirties 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 Jeffrey for additional comments on our commercial highlights. Jeffrey Ryan Stewart. Jeffrey Ryan Stewart. 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 4x 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 5 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 5 years, which is very important to prescribers as roughly 30 percent of psoriasis patients ultimately develop PSA. As well as now our recent approval for pediatric use with the new weight based dosing option. In IBD, SKYRIZI's fastest growing, 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 23 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 front line, 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, with 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 US derm 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 3 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, Ubrellvi, 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 preventative 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 US approval and launch of tevapadon in the third quarter. Feedback from key opinion leaders has been very positive. With tabapadone 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 BENCLEXTA 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 IRA pricing and competitive share pressure. We also launched Decnapaz, 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 deliver 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 BoE, 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 BoE 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 and D highlights. Roopal. Roopal Thakkar. Thank you, Jeffrey Ryan Stewart. I will begin with dermatology programs in immunology. RINVOQ was approved in Europe for the treatment of severe alopecia 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, 3 programs were recently advanced into the clinic. Including an IL-13, IL-31 receptor by 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 US 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 alpha 4 beta 7 antibody and extended half life TL1A antibody, in both Crohn's disease and ulcerative colitis. Interim results for SKYRIZI plus anti alpha-4 beta-7 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 tevapadone. Results from 3 Phase 3 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 2 study for a novel toxin Trenibot in essential tremor. And a phase 1b study for a BBB-1.76 thousand a blood brain barrier crossing anti pyroglutamate a beta antibody 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 2 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 3 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 2 study evaluating tmAbA combinations versus chemotherapy. These results will help inform the development strategy for tmAbA in first and second line CRC as in 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%. TMAb A 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 tMAb a 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 percent response rate and a median overall survival of 15.3 months. Which compares favorably to standard of care. A phase 2 study evaluating tmAbA plus pembrolizumab in frontline will start soon. And in pancreatic cancer, a phase 2 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 ThirdLinePlus trial. If this interim analysis is positive, regulatory submission would occur later this year. A phase 3 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 we will begin by year end. Additionally, encouraging early stage results for ententamig in relapsedrefractory 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 3 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 Tecnopaz 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 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 T. Reents. Scott T. Reents. 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% of sales. The adjusted operating margin was 48.3% of sales which includes a 1.7% unfavorable impact from acquired IPRD 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 2 times within 2 to 3 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 26. With that, I will turn the call back over to Liz. Elizabeth Shea. Thanks, Scott T. Reents. 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 1 or 2. Operator, we will take the first question. Operator. 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. Analyst (Terence Flynn). Great. Congrats on all the progress. Maybe a 2-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 alpha 4 beta 7, 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. Roopal Thakkar. Thanks, Terrence. it is Roopal. So on the CD subcutaneous SKYRIZI, as I highlighted, very strong data. It is with SKYRIZI, so it is a asset well known, to health authorities. And manufacturing is very well known to us. So 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, alpha 4 beta 7, combo data, that you know, I did not specifically call out a meeting. Because of the timing. What we provided earlier was interim data. So 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 And like I said, could be in the fall, and if not possible, we will see it next year. Thanks, Terence. Elizabeth Shea. Operator, next question, please. Operator. Yes, ma'am. We will go next to Carter Lewis Gould with Cantor Fitzgerald. Analyst (Carter Lewis Gould). Great. Good morning. Thanks for taking the question. A follow-up, Roopal. The Phase 2 that you have talked about starting with the alpha-4 beta-7, 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 the not waiting potentially for the full phase 3 data or phase 2 data before moving to phase 3. 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. Roopal Thakkar. Yes, thanks for the question. Yeah. It is a-- it is a large study. it is a platform study that we similar to what we have run before. SKYRIZI is the anchor asset. We will be combining, TROSU or the alpha 4 beta 7 at even a 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 and IBD would be a co formulation. So that data would be collected in Crohn's and ulcerative colitis, in combination with SKYRIZI And then also the reasoning for the scale of that study is also the TL1a is in that trial as well combined with SKYRIZI in Crohn's disease and ulcerative colitis. The enrollment should be starting any moment when a patient will be entered. The trial is ready to go. The other question was around when we can start seeing data. We do not have an intention to wait till the end. We will take a couple interim snapshots And if we see for example, the higher dose of Trosu or the alpha 4 beta 7 agent, is supporting higher efficacy then we would start making plans to move into phase 3 with that combination. And same goes for the TL1A. If we start seeing really strong data, we would start moving quickly into phase 3 We would anticipate right now, hopefully in the first half of 28 being able to kick off phase 3 programs. In IBD. Elizabeth Shea. Thanks, Carter. Operator, next question, please. Operator. Yes, ma'am. We will go next to Christopher Schott with JPMorgan. Analyst (Christopher Schott). 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 Icoand the impact or just lack of impact that is had there. Just can you elaborate a bit more of just what you are seeing in terms of dynamics in psoriasis and just how much more growth opportunity there is for SKYRIZI in this setting given the higher penetration rates? Just then a quick second question is looking ahead to the upcoming readouts for LUTI and RINVOQ and HS. Just talk about your relative confidence in those 2 assets and the role you see each playing in the market there? Jeffrey Ryan Stewart. Yeah. Hi, it is Jeffrey Ryan Stewart. I will take the first question. And as I mentioned, profile is very, very strong, as you know. The skin clearance, the joint protection, the safety, the convenience, a very unique product. And that is why I think we have such a high capture rate. We see a couple of things in the market and I will highlight them. We have not seen a material change in our momentum since the launch of Eiko. So 1 of the things that we look at, I will give you a couple data points We have a fairly detailed Symphony model which looks at sort of sequential share. And what we can see since the launch of ICO, the vast majority of ICO share that we see is being sourced from the 2 other orals in the marketplace. And that is pretty similar to what we had expected. I think the other thing, which is even more important, it is a sort of a quantum measurement. So just to put a fine point on it. When we can track, we can actually see our raw MBRX data in the derm and psoriasis market. And this, of course, is our new starts as well as our switching starts, classical MBRX. And when we look at the data from the launch of ICO, we have absolutely seen no degradation in any of our MB or X trends. In fact, they have actually grown from the launch of ICO in March. So that leads to another point that is probably accurate as we continue to monitor is there still significant headroom in the moderate to severe psoriatic space? A large percentage of patients in The United States and around the world are still not on an advanced therapy. So we do, of course, factor in competitive dynamics into our competitive set and we will continue to monitor. But we are quite pleased with the SKYRIZI momentum, and we think it will continue given the robustness of this marketplace. Robert A. Michael. And Chris, this is Robert. I will just add. I mean we always viewed this as a market expanding, competitive launch, and that is exactly how we are seeing it. Obviously, we are still investing. I mean, I think you have seen some disease awareness investments that we have made, and so we are seeing very nice momentum continue. I think Jeffrey's point that he is highlighting here that we are actually seeing an acceleration of NBRx growth for SKYRIZI since the launch of ICO just further supports our view that this is more of a market expanding opportunity. Roopal Thakkar. Hi, Christopher. it is Roopal regarding the HS questions. You know, we have observed other failures in the space in HS over the years. We did our best to design 2 very robust studies, and enrollment has gone very well. I would say training is very important for the sites Patient selection is very important to make sure you are picking up moderate and severe disease. As we look at distinction between lutikizumab and RINVOQ, lutikizumab studies are enrolling patients that were naive to advance therapies or biologics along with those that had failed, for example, let's say, anti-TNFs, and the primary endpoint there is a high score of 75, so a more stringent endpoint. While including more naive patients. When we look at the RINVOQ design, that is coming post biologic, so for example, post HUMIRA. And given that is 100% after that, 1 has a high score 50 and will have secondary endpoints that will look at high score. 75. So these are things that we were doing to manage the trial outcomes to ensure as high a probability of success as we can. And how I describe the eligibility criteria for these 2 trials will be our go to market strategy, which is very consistent with what we have executed, I would say, very well. Jeffrey's team has done a fantastic job in IBD. With SKYRIZI and RINVOQ. And something similar is how we are thinking here where lutikizumab based on the robust safety profile we observed in phase 2 along with strong efficacy, could allow that to be in earlier lines of patients And RINVOQ, as we have seen over the years across multiple indications, works well as a later line after advanced therapy. So based on those designs, you would see a similar profile in the market with those 2 agents. Just like you have seen very successfully in IBD. Elizabeth Shea. Thanks, Christopher. Operator, next question, please. Operator. Yes. We will go next to Michael Yee with UBS. Analyst (Michael Yee). Thank you. Maybe just pivoting away from immunology for 1 second. Can you just talk a little bit about your expectations on tevapadone launch? Ultimately and how you see this playing out and what could be a slow start, fast start? Maybe just talk a little bit about how you think about that And then similarly in CNS, which you have talked a lot about, seeking to grow, you also have a brain shuttle as well in just wanted to understand a little bit about how you think that is differentiated as there is obviously a lot of interest here given what is going on in Alzheimer's. Thank you. Jeffrey Ryan Stewart. Yes, thanks for the question. I am glad you brought up tevapadone because it is a key piece of our overall long term strategy for growth in Parkinson's. As I highlighted in my remarks, Tavapadon is a very, very unique product there is nothing else like it in the marketplace. it is the first selective D1/D5 agonist. And, obviously, we will have both a monotherapy indication as well as an add on to levodopa-carbidopa orals, the standard of care. And it is quite remarkable data that we see Certainly, 1 of the most impressive dynamics that the thought leaders are very excited about is after 85 weeks of long term utilization of tevapadon, more than 90-plus percent of patients do not need to basically increase their dose of levodopacarbidopa. So essentially, it is kind of pauses the motor dysfunction, which is really, really critical. And there is a belief that, of course, will then spare the dyskinesia. that is just the hallmark of what happens over time. So it is very impressive. The other thing that is impressive, and very distinctive is low, very low rates of sedation or so called sleep attacks, are very challenging in this population. Low rates of edema, and really impulse control disorder. So that profile of efficacy and safety and distinctiveness is quite attractive. Now to get to the nub of your question, we do see that the ramp will be modest at first, and I will tell you why. it is not the profile of the medication. it is largely because based on the timing of the approval, we will not be immediately added into the Medicare formularies. that is gonna take some more time. Based on the way those negotiation works, etcetera. But nonetheless, believe that this will be a substantial addition to the marketplace and clear contributor to that greater than $5 billion peak potential. So lots of excitement for tevapadone. Roopal Thakkar. And Michael, it is Roopal, regarding the 1.76 thousand or the Aliada asset. So that has now entered into 1B settings. So patients who have, disease And the molecule was built to have an extended half life, and we have observed that with the PK data in the first in human studies. The other thing we wanted was a better, cerebrospinal fluid penetration than we saw with a naked antibody, which, let's say, is around 0.1% to 0.2%. This is over 1%, So several-fold higher. So the transport is working. So if we are able to get more, into the CSF, and an extended half life, and you can take down plaque. And specifically, this is targeting abeta, the pyroglutamated type, which we think is the more toxic species. We think that could set up a potential for a subcutaneous agent that could be dosed monthly. So we are looking for, simplicity in the patient experience. So, I would say by next year, we should start seeing data, in, scans to see if we can clear the brain as much as possible. And if we see that, this would wrap move. And in parallel, we are also working on our anti tau program utilizing siRNA and the same shuttle technology What we have observed today is mostly intrathecal approaches, We think, that can be challenging And if we can deliver an siRNA using similar technology, with from Aliada, that could be another benefit Ultimately, down the road, I think, everyone has commented on this to approach Alzheimer's will likely require a combination approach. And I would say AbbVie is well positioned to go after this and hopefully 1 day help as many patients as possible. Elizabeth Shea. Thank you, Michael. Operator, next question, please. Operator. Yes. We will go next to Mohit Bansal with Wells Fargo. Analyst (Mohit Bansal). So I want to come back to HS. And the biggest debate like, you talk to KOLs is that is this, is IL-1 is, simply another inflammatory mechanism for a or it could become meaningful meaningfully superior to, like, IL-17, so everything that is out there. But also in fibrotic and all those components. What evidence do you have today that gives you confidence that lutikizumab could be could actually break through the efficacy ceiling there? And then the second part on this 1, same 1, is how do you are you managing the GLP 1 baseline use in your clinical trials? Because that could actually contribute to high placebo rates here. Thank you. Roopal Thakkar. Yes, thanks, Mohit. it is Roopal. Regarding the efficacy, comparisons, I would say benefit risk comparison So 1, in the Phase 2 study with lutekizumab, we saw very strong data very high deltas that would position it very favorably against anti TNFs and anti IL-17s. We do not see, fungal infections We have not seen flares in IBD. So we think all of that taken together creates a strong benefit risk balance. And as I stated, you would have potentially strong data from RINVOQ as well So that way we would have a dual offering Now when it comes to the GLP use, the trial is quite large. So if there is GLP-1 use, we would see that occurring in both arms. So if it is, if it is happening in placebo and driving up placebo responses, we would anticipate a similar effect in the active treatment arm as well. And then remember, most of these studies started a little bit before the rate of increase, I would say, with GLP-1 usage. But that being said, I think weight loss is a potential important driver of inflammation, and pain in the disease. And having our 295 asset, our amylin, and potentially in combination with ludi is another approach that is under consideration I have already mentioned blocking anti or blocking IL-23 with SKYRIZI and the comma with amylin. In psoriasis. So I think your observations are spot on what is occurring. And we would like to, build off of those observations even in our obesity franchise combined in our immunology franchise. Elizabeth Shea. Thanks, Mohit. Operator, next question please. Operator. Yes, ma'am. We will go next to Asad Haider with Goldman Sachs. Analyst (Asad Haider). Great. Thanks for taking the question and congrats on the quarter. Maybe just we can talk about oncology. Robert, I know you have said in the past that this does not get enough attention So maybe just a question on the broader oncology strategy and of your key programs in the context of a rapidly evolving landscape where both ADCs and PD 1 budget programs are in high focus. So first, what are we gonna learn about tMAb a in the upcoming readouts? And where do you see this ADC differentiating from others like Merck's sac TMT or AstraZeneca's data DXP And then related, on the PD-1/VEGF compound that you licensed from RemGen, I think Rupal used said that there will be some data at World Lung in a couple of months and that you have previously noted that you are considering accelerating that program into phase 3. With chemo combos and ADC combos. So just any preview of what we can expect at World Lung and on your overall development strategy? Thank you. Roopal Thakkar. Thanks, Asad. it is Roopal here. So regarding our ADC portfolio, if you look for a second, and it is happened pretty quickly, we have Elahere, Amrelis, and now DecNUPAS on market. So there is 3 ADCs already out there. The Amrelis asset is already in C Met, in second line lung. So physicians are already getting experience. So in terms of differentiation, it is already starting now. With Umbrella because folks are now learning about c Met testing and they are seeing, you know, I would say really reasonable uptake in Amaryllis that is exceeding our expectations. So that is the first point. And as we move on to tmAbA, as I described, we are already well into phase 3 in combination with bevacizumab in third-line lung, colon cancer. and colon, which is not all that different from ovarian, which is gonna get crowded. But right now, it is all chemo based. So it is a very broad market. And we see high rates of cMAT expression in these tumors especially in later line. So that is going to be in an all-comer population. And recall in phase 2, against the standard of care, we saw zero percent response rates with, 30% response rate with tmAbA plus Bev in that third line setting. What I mentioned earlier today was data readouts in second-line CRC, the larger population. the therapy in frontline and second line is similar. And if we see strong data there, against irinotecan, we are trying to replace irinotecan. If we see higher response rate and deeper response rates, then we are positioned to move tmAbA into the front and second line setting, which are large markets. Now what we will be evaluating as you get into earlier lines is how c Met expression looks. We tend to see it quite high in later lines. So what that could allow us then is to have a biomarker directed approach which, as I stated, the community and academic centers are becoming very familiar with CMAT testing. And that could be a strategy in frontline and second line. that is another layer of differentiation. Physicians want to individualize care and maximize benefit risk, and how that can occur in on ADCs is first, we optimize the dose, select the right patients, and then deliver a biomarker to the field so they can do exactly that as individualized care. So I would say these are distinctions that will further differentiate Now we are also studying in head and neck, as I described, in ovarian, and we are positioned as those data read out to move into phase 3. I would say in particular in ovarian, we know ovarian already in the FR alpha space And if we do a c Met directed approach in ovarian, that would be highly distinctive and differentiated from everyone else let's say majority pursuing FR alpha, we see, little overlap between the 2 biomarker approaches. So another individualized approach And if I step back further and look at the work that we are doing in lung with tmAbA, we are exceeding efficacy levels that we saw with Amrelis. So combinations in the frontline are gonna be very important. And that is where PD-1/VEGF can come in. And as we are establishing that, early on, and you will see that at World Lung, what you will see is response rates and PFS in lung And we anticipate seeing a very competitive profile when it comes to efficacy, tolerability, safety. And we think at this stage, if we have optimized dosing and we get concordance with regulators, we can move into phase 3 very rapidly as a chemo combo And then in parallel, start testing our ADCs in combination with that PD-1/VEGF across tumor types So that would include lung, as we already stated, and also potentially ovarian amongst other tumor types. I want to take up too much time, but 706 and CEDS6 is our ADC, which has shown very strong data in small cell lung cancer. that is in phase 3 now. And I will highlight our PSMA Steve bispecific antibody 969 showed very strong data at ASCO and that 1 is now well positioned to start moving into phase 3 into prostate cancer and can be very competitive and will not have all the logistical challenges of radioligand therapy. So that is a snapshot I would say much more to come, and, we are very excited about this portfolio and oncology. Elizabeth Shea. Thanks, Assad. Operator, next question, please. Operator. We will go next to David Amsellem with Piper Sandler. Analyst (David Amsellem). Thanks. So in light of your comments on RINVOQ in AA and vitiligo, particularly regarding vitiligo, just how do you square your expectations in terms of peak with an increasingly crowded development landscape inclusive of other agents like IL-22s, So that is number 1. And then maybe switching gears to bretasilocin and the psychedelics slash neuroplasticins. How are you thinking about positioning of that agent? I know there is a lot of development work ahead, but wanted to get your thoughts on positioning, in light of the recent MDD data for Definium's form of LSD. So if you could comment on that, that would be helpful. Thank you. Jeffrey Ryan Stewart. Yes. I will take the vitiligo question. it is Jeffrey Ryan Stewart. You know, and what we have seen, and I think the whole world has seen this over time, is that these immunology markets are amazingly resilient and very expansive once these technologies come in. And I think we have seen that over and over again. We have talked about how you know, years ago, you start to establish immunology segment, and then you start getting second line, third line, You know, these are lifelong conditions. And I think the first the first key piece is vitiligo. Obviously, there is no systemic treatments approved. We will be the first. So in terms of that dynamic around being particularly effective for the higher body surface areas, which are quite common. And, obviously, the topicals just do not make sense there, if they are active. it is just very difficult to manage creams. And when you look at the efficacy that we start to see, particularly in the longer term extensions that just builds over time the ability to really systematically clear the skin is quite striking. So that gives us a significant amount of confidence in terms of how these markets will cascade and our ability to manage it. Plus, we have an extremely strong position. I mentioned in my remarks that we have already started to expand our, essentially, our RINVOQ sales force. So our ability to bring multiple indications with long term safety data across the board, whether it is atopic dermatitis, alopecia, vitiligo, we will have, I think, a strong position to lead this emergence of the vitiligo market So that is how we see it. I will let Rupl handle the bretasilocin dynamic. Roopal Thakkar. Hey, David. it is Roopal. And you know, regarding vitiligo and alopecia areata, the head start is very beneficial. And at this stage, we do not know how all the other assets will play out. In terms of longer term safety and efficacy. RINVOQ is very well characterized with well over a decade of safety data and the familiarity already exists in atopic derm and it will build further with alopecia areata and vitiligo. And then we also anticipate improving improvement in efficacy over time. So that is to add to Jeffrey's comments. And then on bretasilocin, several areas of differentiation. 1 is the short time of the experience. Majority of the patients within 2 hours are ready to leave the clinic. So I think that is 1 advantage. The second advantage, I would say, is the experience itself. Where with bretasilocin is described as visual and a rich experience. Some of these other assets that are being development that are being developed can be quite intense, Some have described them as unpleasant and distressing. The clinics with some of these assets will observe loss of consciousness where a patient becomes unresponsive So that is not something that we have observed with bretasilocin along with that short duration of effect. The other notable, mechanistic quality is the fact that it is an antagonist -- it is antagonistic at 5-HT2B. And many of the others are still agonistic. At that receptor And recall, that is the receptor where you see cardiovascular toxicity, with thickening of cardiovascular valves and regurgitation. So we do not see that as a problem which could set up the potential for chronic use. And we are, under study with MDD, and also considering PTSD and, among others. So hopefully that gives you a good sense of why we like this asset and how it can be differentiated once hopefully it gets to market. Elizabeth Shea. Thanks, David. Operator, next question, please. Operator. Yes. We will go next to Luisa Hector with Berenberg. Analyst (Luisa Hector). Hello. Thank you for taking my question. I wonder if you can give us any kind of early indication from formulary season. I hear levels of confidence as usual on SKYRIZI and RINVOQ. So just sort of checking around pricing environment and impact of some of their head to head studies from competitors. And then just a quick check post the announcement of Apogee. Did you deprioritize any of your own pipeline assets in AD around that time in connection with Apogee? Thank you. Jeffrey Ryan Stewart. Yes. Thank you for the question. it is Jeffrey Ryan Stewart. And I would say that the progression of our discussions with payers, you know, we obviously are in contracting season here. Which typically starts in the, you know, early spring. It seems like it starts earlier and earlier. But I would say we are you know, while these negotiations are always tough negotiations with the payers, I would say they are relatively consistent very consistent with what we have seen over the years. As you know, we have highlighted before that, particularly in immunology, that this is a volume driven business, and we see sort of low single digit concessions around rebates and price concessions as the standard, and our position really has not changed from that standpoint. So we are continue to be encouraged with how things will play out. We are not done yet, obviously, but we have a very strong hand here, and our consistency should be appreciated. Roopal Thakkar. And, Luisa, it is Roopal. And also on the head to head question, what we have observed over time with these head to heads against SKYRIZI the data gap closes over time. So you see less and less of a separation. And clinicians really like the safety profile, and patients like the quarterly dosing So there is going to be continued strong demand for SKYRIZI And on the question on our own atopic dermatitis, assets, I would say we are running all of them, in parallel and as quickly as we can. Obviously, we wanna move the anti-IL-13 as quickly as possible. And whatever we can do to help that post deal closure. We are gonna do that. And we are in the clinic with our 31 bispecific, and should be shortly in the clinic with an IL-13/18 bispecific. In atopic dermatitis and then potentially even asthma. And then there is a 31 monoclonal that is coming with Apogee, and that is something else that we wanna test as well. And all of these assets that we have mentioned are gonna be long acting So it will if they can deliver the efficacy that we want to see, we will also be able to deliver that convenience, to patients as well. Elizabeth Shea. Thanks, Luisa. Operator, next question please. Operator. We will go next to Matthew Phipps with William Blair. Analyst (Matthew Phipps). I want to ask about AbbVie 85.9 thousand, the oral IL-23 receptor inhibitor. You talked a little bit about Ico coming into the market. How do you see the differentiation for 859, and maybe how you will position it across other indications? Thank you. Roopal Thakkar. Thanks, Matthew. it is Roopal. So the what we liked preclinically about this asset was the potency And if that can play out that may be a way to allow the dose to be a little bit higher and to get much better coverage. Right now, when we see, how Skyrizi provides coverage, it is much, much deeper, and we see higher response than the oral and many other assets. And we think that, could be potency and how high you can push the dose that is still tolerated by the patient and still needs to make sense from a cost of goods standpoint. that is 1 aspect. The second aspect is around half life, Many of our, orals will have short half lives. And if you if you have a drop what we call Cmin, that is when the concentration reaches a low. You could be losing efficacy. So with this 1, we have, a design element that allows for an extension of half life. And we will start seeing that data, I would say, next year to see if we do see an extended duration of half life that could exceed a day or 2 or even further And if you have that, you can have much better coverage potentially drive higher efficacy where we would like to get it hopefully closer and closer to SKYRIZI And could there be the question mark still remains is could there be a question here You may not require daily dosing. If the half-life is extended long enough, could you, run-in quickly in a starter pack and could you even take this once a week? And that is something we have observed preclinically, but now we will have to see if it plays out in humans and that those studies are kicking off imminently. Elizabeth Shea. Thanks, Matthew. Operator, next question, please. Operator. Thank you. We will go next to Louise Chen with Scotiabank. Analyst (Louise Chen). Hi. Thanks for taking my question. I wanted to ask you on SKYRIZI subcutaneous. If you get this 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? Thank you. Jeffrey Ryan Stewart. Yes, thanks for the question. Jeffrey Ryan Stewart. Like we do expect a meaningful acceleration for SKYRIZI because of this. And if you think about it, right, the number 1 market value driver in IBD is efficacy. On these stringent endpoints we talked about, like endoscopic response, endoscopic healing. And the whole aspect over the subcu induction, it allows a certain segment of physicians to not have to work across 2 different reimbursement channels, like, you know, a Part b or a medical channel and then a pharmacy channel for the sub q. So in that sense, it is convenient. So when we look at our data that Rupl and I highlighted, you look at the availability of that induction, you are sort of hitting on all of the market value drivers. So very strong efficacy and the most stringent endpoints. You know, more convenience on induction so certain segments do not have to work across both reimbursement channels. And then lastly, we have obviously a very strong position for our maintenance convenience. So with that with those 3 things, we are planning for an acceleration of our capture rate. Now having said that, it will take you know, a month or 2 or a few months to sort of fully ramp up the availability, based on our contracts. So we will probably start seeing that really early in 2027. But, nonetheless, our ability to start to communicate and, basically highlight, this, this innovation will come here in the fourth quarter. Robert A. Michael. And Louise, this is Robert. I will take your question on the SKYRIZI LOE. I mean, SKYRIZI's composition of matter patent expires in 2033 as you noted, we do have later expiring IP granted and in process that embodies SKYRIZI's significant innovation. And this includes patents expiring in The US in the mid 20 thirties and later. Now it is important to note, though, 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. Obviously, we have a strong track record of vigorously defending our patents and protecting our innovation, and I would expect that to continue. Elizabeth Shea. Thanks, Luisa. Operator, we have time for 1 final question. Operator. Yes, ma'am. We will go next to Evan Sigerman with BMO Capital Markets. Analyst (Malcolm Hoffman). Hi, I am Malcolm Hoffman on for Evan. Thanks for taking our question. For bretasilocin, I know you had said 100 milligrams is safe and tolerable with further escalation plans. Can you speak to why you may be confident this increased dosing could translate into improved efficacy? Above what we had previously seen with the asset? Are you looking at receptor occupancy data? Just trying to get a sense of confidence here. Thanks. Roopal Thakkar. Hi, it is Roopal. I will take that. Yes, 100 milligrams is looking good, and that will be the lowest dose that we would take forward. Next is 150. And as you stated, receptor occupancy when we noted the previous EMPOWUR datasets was lower than what we would have wanted. So as we are able to increase the dose, we do anticipate much higher receptor occupancy The other observation is PK variability. Even within patients. So if we can deliver a higher dose we can have a better consistent PK, dose to dose and then over time, improved receptor occupancy We still like this profile If we can deliver on that efficacy, we are seeing good safety. it is once a day. And we are not having the GI adverse events I think that can be quite problematic today in schizophrenia. So more to come, and phase 2 is kicking off later this week. Elizabeth Shea. 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. Operator. This does conclude today's call. Thank you for your participation. You may now disconnect.
