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spk09: Good morning, and thank you for standing by. Welcome to the AbbVie first quarter 2023 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. I would now like to introduce Ms. Liz Shea, Senior Vice President, Investor Relations.
spk10: Good morning, and thanks for joining us. Also on the call with me today are Rick Gonzalez, Chairman of the Board and Chief Executive Officer, Rob Michael, Vice Chairman and President, Jeff Stewart, Executive Vice President and Chief Commercial Officer. Scott Rentz, Executive Vice President and Chief Financial Officer. Carrie Strom, Senior Vice President and President Allergan Aesthetics. And Tom Hudson, Senior Vice President R&D and Chief Scientific Officer. Joining us for the Q&A portion of the call is Rupal Thakkar, Senior Vice President Development and Regulatory Affairs and Chief Medical Officer. Before we get started, I'll note that some statements we make today may be considered forward-looking statements based on our current expectations. Abbey 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. Abbey 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 Abbey's business performance. These non-GAAP financial measures are reconciled with comparable GAAP financial measures in our earnings release and regulatory filings from today, which can be found on our website. Following our prepared remarks, we'll take your questions. So with that, I'll turn the call over to Rick.
spk20: Thank you, Liz. Good morning, everyone, and thank you for joining us today. I'm extremely pleased with our start to 2023, with first quarter total revenues and adjusted earnings per share both exceeding our expectations. This performance was driven by Double-digit sales growth from several key products, including Skyrizzy, Rynvoke, Benklexta, and Valar. Positive momentum from our aesthetics business, with strong results internationally and stabilizing consumer trends in the U.S. An in-line performance from U.S. Humira, where biosimilar erosion is tracking as expected, with much of the impact driven by price. Since our inception, We have successfully created a well-diversified portfolio with multiple growth platforms in highly attractive markets, including immunology, hematological oncology, neuroscience, and aesthetics. Our commercial execution, including the launch of new products and expanded indications, has been outstanding, especially across SkyRise and Renvoke, and recently with Valar and MDD. Each of these assets are expected to contribute significant revenue growth over the decade. The breadth and the depth of our R&D pipeline also supports our long-term growth outlook, and we anticipate numerous important pipeline milestones over the next two years. In summary, we are one quarter into the U.S. biosimilar event for Jumeirah and are managing the erosion well. Most importantly, our growth platform is demonstrating strong performance, exceeding our expectations. We are executing well across all aspects of our business and see numerous opportunities for our diverse portfolio to drive long-term growth. With that, I'll turn the call over to Rob for additional comments on our business performance.
spk05: Rob? Thank you, Rick. We're off to an excellent start in 2023 with each of our five key therapeutic areas meeting or exceeding our first quarter expectations, a testament to the strength of our broad portfolio. We delivered adjusted earnings per share of $2.46, which is 10 cents above our guidance midpoint. Total net revenues were $12.2 billion, approximately $400 million ahead of our expectations. First quarter results include continued robust performance from Sky RISD and RINVOC which remain on track to contribute more than $11 billion in combined sales this year. Growth rates in the first quarter for both products are consistent with our full-year expectations. Skyrizzy and Rynvoke are demonstrating momentum across all approved indications, and we expect to round out their opportunities in IBD later this year. This includes Rynvoke's anticipated U.S. approval in Crohn's disease, as well as Sky RISD's European launch in Crohn's and its global regulatory submission in UC. We are also performing exceptionally well in neuroscience. Total net revenues this quarter were nearly $200 million above our guidance, with Raylar sales accelerating following MDD approval and migraine delivering strong growth. As a result, we will be increasing our full year outlook for neuroscience. Aesthetics is also performing better than expected. We are seeing positive recovery trends in China and some stability in the U.S. market where we are closely monitoring several economic indicators that correlate with aesthetics procedures, including consumer confidence, personal consumption, and Google searches. Although it's still early in the year, these positive trends, especially across our international markets, give us the confidence to increase our full-year outlook for aesthetics as well. This continues to be an under-penetrated market with significant growth potential. Based on our robust performance this quarter and a continued strong outlook for our business, we are raising our full-year adjusted earnings per share guidance by 10 cents and now expect adjusted earnings per share between $10.72 and $11.12. In closing, I'm extremely pleased with the performance of our diverse portfolio. We're off to a strong start to the year, which further reinforces our confidence in the long-term outlook of the business. With that, I'll turn the call over to Jeff for additional comments on our commercial highlights. Jeff?
spk04: Thank you, Rob. I'm very pleased with the strong commercial execution across our therapeutic portfolio. Immunology delivered total revenues of approximately $5.6 billion, with continued robust double-digit growth from Skyrizzy and Rynvoke. Skyrizzy global sales were nearly $1.4 billion, reflecting operational growth of more than 46%, despite retail inventory destocking in the quarter. Skyrizzy is the clear market leader in the U.S. biologic psoriasis market, with a total prescription share now at 30%. In psoriasis, Skyrizzy has set a very high bar relative to other therapies on the market or in development, with differentiated attributes across the categories that physicians and patients deem most important. This includes the rapid onset of action after the first dose, nearly complete skin clearance with multifold higher rates on PASI 90 and PASI 100, high durability of response, which we have demonstrated can increase over time. as well as quarterly dosing for maintenance therapy, a convenient alternative to daily oral or more frequently administered injectables. With a nearly 50% U.S. in-play share of new and switching patients, there is substantial room for Skyrizzy's continued growth in psoriasis. This best-in-class profile is supporting strong momentum now in psoriatic arthritis, with Skyrizzy achieving an in-play biologic share of roughly 20% in the U.S. dermatology segment. Skyrizzy is also being co-positioned with Renvoke in the U.S. room segment in PSA, where we are seeing increasing utilization among rheumatologists as well. Globally, Skyrizzy has achieved in-place psoriatic disease leadership in more than 25 countries and total market share leadership in nearly 20 of those key markets. In Crohn's disease, we are seeing very fast adoption of Skyrizzy in the U.S., with a total in-play patient share at approximately 20%, second only to Stellara. Feedback from gastroenterologists is very positive, especially as it relates to Skyrizzy's novel dosing and overall clinical profile. We see strong uptake in Japan and Canada as well, with the European launch forthcoming. We also recently reported strong induction data for Skyrizzy in ulcerative colitis, which Tom will discuss momentarily. Based on the results of that trial, it is increasingly clear that Skyrizzy represents a differentiated asset across inflammatory bowel disease, and we look forward to bringing this potential new indication to physicians and patients next year. Turning now to RINVOQ, which delivered global sales of $686 million, reflecting operational growth of more than 50%, despite similar retail inventory destocking in the quarter. I'm very pleased with the performance in rheumatology, with total prescriptions increasing across each of the four approved indications. Atopic dermatitis is also tracking in line with our expectations. We continue to see market share momentum globally, including in-play patient share increasing to approximately 17% in the U.S. We are very excited about the growth potential in gastroenterology. RINVOC has set a high bar for efficacy in both ulcerative colitis and Crohn's disease, demonstrating strong rates of remission and endoscopic improvement. We're seeing very strong momentum in UC, where adoption has been robust. RINVOC is now achieving a 23% in-place share in the US Second Line Plus setting. reflecting an impressive ramp since our launch in UC less than one year ago. This accelerated adoption among gastroenterologists is very encouraging for RINVOC's pending outlook in Crohn's. We are currently launching this indication in the EU, a geography where RINVOC is the only JAK approved to treat both IBD conditions, and we remain on track for CD approval and commercialization in the US later this quarter. with broad formulary access anticipated to ramp quickly over the back half of this year. So we see inflammatory bowel disease continues to be an area of high unmet need. Having two novel therapies in IBD with Skyrizzy and Renvoke that each deliver differentiated levels of efficacy is an important step forward for patients. And with these two complementary assets, we are very well positioned to compete against other oral or biological agents. Global Humira sales were approximately $3.5 billion, down 24.3% on an operational basis due to biosimilar competition. Erosion in the US remains in line with our expectations, with most of the impact driven by price. Turning now to hematologic oncology, where total revenues were $1.4 billion. with continued pressure on Imbruvica, partially offset by robust double-digit growth with Venclexta. Imbruvica global revenues were $878 million, down 25.2% due to increasing competition and the cumulative impact of a suppressed market. Venclexta global sales were $538 million, up 17.5% on an operational basis, with strong momentum across both AML and CLL. In neuroscience, revenues were approximately $1.7 billion, up 15% on an operational basis. Raylar is performing exceptionally well. Sales of $561 million were up 31.3% on an operational basis, above our expectations. We are very pleased with the AMDD label and the launch, which has resulted in a significant uplift in total new prescriptions for Raylar. With a dedicated sales force that calls on both psychiatrists and primary care, as well as ramping DTC promotion, we see an opportunity for accelerated growth across all approved indications, and we will be raising our full-year guidance for Vrelar accordingly. Within migraine, we remain uniquely positioned with a portfolio to support complete migraine freedom. Our leading oral CGRP therapies contributed $218 million in combined sales this quarter. reflecting growth of more than 45% as we continue to see strong prescription demand for both Eubrelvy and QLipta. We recently expanded the label for QLipta, which is now uniquely positioned as the only oral CGRP available as a preventative treatment for patients with both chronic and episodic migraine, further strengthening our competitive profile. Lastly, Total Botox therapeutic sales were $719 million, reflecting strong performance in chronic migraine, as well as other approved indications. So overall, I'm extremely pleased with the performance across the therapeutic portfolio. And with that, I'll turn the call over to Carrie for additional comments on aesthetics. Carrie?
spk13: Thank you, Jeff. First quarter global aesthetic sales were approximately $1.3 billion, which came in ahead of our guidance primarily due to a faster reopening in China, as well as a slightly stronger economy in the U.S. versus our planning assumptions. In the U.S., aesthetic sales were $777 million, down 8.1% as we continue to see softness in aesthetic procedures related to inflationary dynamics. As a reminder, we saw very robust performance for our U.S. performance in the first quarter of 2022, which created a difficult comparison for growth in the first quarter of this year. U.S. Botox cosmetic sales were $409 million, down slightly on a year-over-year basis. We continue to see a lesser impact from inflationary dynamics on Botox cosmetic compared to other areas of our aesthetic portfolio due to its relatively lower price point and large in-cell base of loyal repeat consumers. The U.S. cosmetic toxin market was down low single digits in the first quarter on a year-over-year basis. Botox cosmetic continues to be the clear market leader, and its share of the U.S. toxin market remains stable. Sales for our U.S. Juvederm collection were down 18% as our dermal filler portfolio continues to be impacted by inflationary pressure on consumer spending. The U.S. filler market was down nearly 20% in the quarter on a year-over-year basis, due to the persistent inflationary environment. Our Juvederm collection remains the clear market leader and share was stable in the quarter. The economic pressure on our U.S. dermal filler business is partially offset in the quarter by strong initial uptake for our recently launched Volux filler, which is approved for the improvement of jawline definition. We expect Volux, combined with the upcoming launch of our skin quality injectable SkinVeve, to support long-term growth for our filler portfolio in the U.S. While the aesthetics category in the US continues to be challenged due to the soft economy, the key external economic metrics that we track have remained relatively consistent with year-end 2022 levels. Our international aesthetics portfolio continues to demonstrate robust growth, with strong performance in Japan, which is rapidly growing, and China, which is recovering faster than expected. Sales from our international aesthetic portfolio were $523 million, up 7.8% on an operational basis. International Botox cosmetic sales grew approximately 17.5% operationally, and international Juvenerm sales were down approximately 1.4% on an operational basis. China, which is our second largest market, was negatively impacted by COVID in January and February, but experienced a sharp recovery in March. We expect this level of activity to be sustained throughout the remainder of the year. Recall our original guidance assumed we would not reach a full recovery until the second half of this year. And in Japan, which is an underdeveloped market and proving to be very responsive to promotion, we continue to make significant investment in injector training, our field force, and consumer education. Overall, we are pleased with how our team has been executing through this dynamic environment and remain encouraged by improving trends internationally and stabilization across our US portfolio. These positive trends and continued strong momentum give us the confidence to increase the full year outlook for our aesthetics business. Longer term, we remain extremely confident in our ability to grow the aesthetics business and continue to expect to achieve total sales of more than $9 billion by the end of this decade. Aesthetics continues to be an extremely attractive, under-penetrated market, and our proven ability to drive consumer demand and develop a strong base of loyal customers, as well as bring innovative new products to the market, will support robust growth over the long term. With that, I'll turn the call over to Tom.
spk17: Thank you, Carrie. We've continued to make very good progress with our pipeline to start this year. In immunology, we recently received European approval for RENVOLC and Crohn's disease, making it the first JAK inhibitor approved for this indication. We continue to anticipate FDA approval for Rhinvolc and Crohn's disease next month. We also recently announced positive top-line results from our Phase III induction study for Skyrizzy in ulcerative colitis, which is a disease with unpredictable symptoms and frequent players, making it challenging to manage. In our study, Skyrizzy met the primary and all secondary endpoints, demonstrating a very strong impact on the disease as measured by clinical remission, clinical response, and endoscopic improvement. We're particularly pleased with SkyRisi's impressive performance on the more stringent measures in this trial, with approximately 37% of SkyRisi-treated patients achieving endoscopic improvement compared to 12% of patients on placebo. This level of efficacy has the potential to position Skyrizzy as a highly effective therapy, and we believe it will be a welcome new treatment option for physicians and patients once approved. Detailed data from this induction study will be presented at a forthcoming medical meeting. We expect to see data from the phase three maintenance study in the second quarter with our regulatory submissions planned for the second half of the year. In oncology, We continue to make good progress across all stages of our hematology and solid tumor pipelines. We remain on track for several important regulatory and clinical milestones this year, including regulatory approval for ecuritumab in relapsed refractory large B-cell lymphoma, phase III data from Van Cleck's Canova trial in relapsed refractory multiple myeloma patients, with a T11-14 mutation, and Nebidoclax's TRANSFORM-1 trial in frontline myelofibrosis. And Phase II data for Teliso-V and Second Line Plus advanced non-squamous, non-small-cell lung cancer, which has the potential to support a regulatory submission for accelerated approval. We're also beginning to see very encouraging data for our next-generation CMAT ADC, which uses a more potent topopayload than our Teliso-V ADC. Based on the data we've seen to date for ABBV400 in our phase one solid tumor basket study, we plan to expand the program to earlier lines in colorectal cancer, as well as evaluate in other tumors where CMED is expressed, including pancreatic and liver cancer. Moving to our neuroscience pipeline, where we've recently received FDA approval for QLIPTA as a preventive treatment for patients with chronic migraine, making it the only oral CGRP antagonist approved for prevention of both episodic and chronic migraine. In our phase three study, QLIPTA provided a significant reduction in migraine days, as well as significant improvements in function and quality of life in patients with chronic migraine. a common and debilitating disease. As a highly effective oral treatment option, we believe QLIPTA will be well positioned in the chronic migraine prevention market. In Europe, we continue to anticipate an approval decision in the third quarter for etogepant as a preventive treatment for patients with both chronic and episodic migraine. Turning now to ABBV951, we announced that we received a complete response letter for our regulatory application in the U.S. The FDA has not asked for additional efficacy or safety studies related to our drug device delivery system, but rather they have requested additional information regarding the pump, as well as updates to instruction for use. We are working to generate the necessary information, and we expect to respond to the CRL later this year with an FDA action anticipated in the first half of 24. In international markets, we recently received approval for 951 in Japan, and we continue to expect approval in Europe in the fourth quarter of this year. In our early stage neuroscience pipeline, we recently began phase one studies of our selective D3 dopamine receptor agonist, ABBV932. Our experience with DRAIL-R has highlighted the potential clinical benefit of achieving D3 selectivity and we believe that a compound that more selectively engages the D3 dopamine receptor has the potential to provide enhanced efficacy. Our program will initially focus on general anxiety disorder with the potential to expand to other neuropsychiatric disorders. The programs under a collaboration with Calico are also progressing well. We now have four assets in clinical trials, including two PTPN2 inhibitors in phase one in oncology, our EIF2B activator for neurodegenerative diseases, and an IGF-1 signaling pathway modulator that will be explored in aging-related diseases. Our most advanced program is the EIF2B activator 7262. The first patient was recently enrolled in a HEALY ALS platform trial, a Phase II-III study conducted by the HEALY Center for ALS at Mass General. This trial is designed to evaluate multiple therapies simultaneously with a goal to accelerate the development of potential breakthrough treatments for ALS. Now I'd like to provide a brief update on two earlier stage programs in our therapeutic pipeline. In cystic fibrosis, we recently analyzed data from an ongoing proof-of-concept study evaluating our triple combination therapy. The results from this interim analysis did not meet our criteria for advancing, and we are discontinuing our cystic fibrosis program. We also recently reviewed interim data from our exploratory studies for ABVV154 in PMR and Crohn's disease. Similar to results from the RA study, While we observed efficacy with 154, we also observed some changes in biomarkers that are consistent with systemic steroid exposure at the higher doses. The benefit-risk profile does not sufficiently differentiate 154 from other available treatments. But based on the totality of the data across RA, PMR, and Crohn's disease studies, we will not be pursuing further development of this asset. Now moving to our aesthetics pipeline, we recently saw data from our Phase III studies for Botox in platysma prominence and masseter muscle prominence. In our study for prominent neck muscles, Botox met all primary and secondary endpoints, demonstrating a significant reduction in the unwanted appearance of platysma prominence on the neck and jawline. This was the first of three Phase III studies in platysma prominence with data from the two remaining trials expected in the second half of the year, followed by regulatory submission in the U.S. near the end of 2023. Botox also performed very well in our study for prominent masseter muscles, meeting the primary and all secondary endpoints in the trial. Our program is initially focused on China and other Asian markets, as masseter prominence is common in Asian populations, and there's significant unmet need for minimally invasive treatment options. Based on the results from this trial, we expect to submit our regulatory application in China in the second half of the year. Once approved, we anticipate high demand for Botox in this novel indication, which will help to further build our portfolio in the lower phase segments. So, in summary, we continue to demonstrate significant progress across all stages of our pipeline and anticipate numerous important regulatory and clinical milestones throughout the remainder of 2023. With that, I'll turn the call over to Scott.
spk18: Thank you, Tom. I will discuss our most recent financial results and guidance. Starting with our first quarter results, we delivered strong top and bottom line performance. We reported adjusted earnings per share of $2.46, which is 10 cents above our guidance midpoints. These results included $0.08 unfavorable impact from acquired IP R&D expense. Total net revenues were $12.2 billion, $400 million ahead of our guidance, and down 8.3% on an operational basis, excluding a 1.4% unfavorable impact from foreign exchange. The adjusted operating margin ratio was 45% of sales. This includes adjusted gross margin of 84.2% of sales, adjusted R&D investment of 13.6% of sales, acquired IP R&D expense of 1.2% of sales, and adjusted SG&A expense of 24.4% of sales. Net interest expense was $454 million. The adjusted tax rate was 13.7%. Turning to our financial outlook, we are raising our full year adjusted earnings per share guidance to between $10.72 and $11.12. This earning per share guidance does not include an estimate for acquired IPR&D expense that may be incurred beyond the first quarter. We now expect net revenues of approximately $52.4 billion, an increase of $400 million. At current rates, we expect foreign exchange to have a modest unfavorable impact on full-year sales growth. This guidance includes the following updated assumptions. We now expect Raylar sales of approximately $2.7 billion, an increase of $200 million, reflecting strong prescription growth following the MDD approval. And for aesthetics, we now expect global revenue of approximately $5.3 billion, reflecting the better-than-expected recovery in China and stable economic trends in the U.S. Turning to the second quarter, we anticipate net revenues of approximately $13.5 billion, which includes U.S. Humira erosion of 27%. At current rates, we expect foreign exchange to have a 0.6% unfavorable impact on sales growth. We are forecasting an adjusted operating margin ratio of 48.5% of sales. We are modeling a non-GAAP tax rate of 15.4%. We expect adjusted earnings per share between $2.90 and $3. This guidance does not include acquired IP R&D expense that may be incurred in the quarter. In closing, we're off to an excellent start to the year. with strong performance across the portfolio and financial results ahead of our expectations. With that, I'll turn the call back over to Liz.
spk10: Thanks, Scott. We will now open the call for questions. In the interest of hearing from as many analysts as possible over the remainder of the call, we ask that you please limit your questions to one or two. Operator, first question, please.
spk09: Thank you. Our first question comes from Terrence Flynn with Morgan Stanley. Your line is open.
spk08: Great. Thanks so much for taking the question. Maybe two for me. Just on immunology, can you quantify the amount of destocking for both SkyRizzy and Renvoke in the quarter? I think Biogen on their call spoke to some tighter working capital requirements at wholesalers due to rising interest rates. So just wondering if you're seeing something similar here and just to want to be sure that's not a pricing dynamic. And then can you elaborate at all about your ALS program when we might see some data there? Thank you.
spk05: Hi, Terrence. It's Rob. So on the retail inventory destocking, we do typically see this in the first quarter, so it wasn't a complete surprise. In fact, it was factored into our guidance. We did beat our guidance on immunology for the quarter. The impact was high single digits, both for Skyrizzy and Renvoq. In terms of absolute value, you're talking about around $70 million for Skyrizzy and $30 million for Renvoq.
spk04: And it's Jeff. Just to clarify on your wholesale comment, I think as Rob highlighted, it's in the retail. So it's in the specialty pharmacy channel. And you'll recall, as you know, there's about 18 specialty pharmacies that basically distribute the I&I products, and there's some big ones there. So it was not a wholesaler dynamic. It was a retail inventory dynamic, which, again, as these products get bigger, we do see and contemplate in our projections.
spk05: And then, Terrence, this is Rob. Just to more broadly answer the question that I'm sure many investors have, if you look at the growth in the quarter, so overall, U.S. demand was up just north of 60% for Invoke and Sky Rizzi. We saw very strong performance across all approved indications, as Jeff highlighted. We did have the two partial offsets, one being the retail inventory destock, which I've already quantified, and then price was down high single digits, and that's really driven by rebate increases, which is typical when you see the type of volume increase. And we saw Sky RISD sales up 80% last year, Renvoke in the US up 40% last year. So when you see that kind of volume growth, and couple that with the number of indications we had approved, we had five new indications for Renvoke and two for Sky RISD. So it was something we were contemplating. It was factored into our guidance, but I don't know that the streak fully appreciated that in terms of the first quarter estimates that were put out there.
spk17: This is Tom for the ALS question. I'd say about two years. We have to recruit the patients, and there's about a year of follow-up that is needed. So I'd say late 24, early 25. All depends on the enrollment, which I understand is starting off on a good pace.
spk10: Thanks, Terrence.
spk09: Terrence, operator, next question, please. Thank you. Our next question comes from Steve Scala with Cowan. Your line is open.
spk03: Oh, thank you. A couple questions. Some of your peers have called out copay resets early in the year that have led to more modest performances in products such as Dupixent and Cosentix. Evi has been less vocal on this point. How much was that a factor, or are Skyrazi and Renvoke different in some way? And then secondly, despite the solid performance in Q1, the EPS guidance range continues to be very wide. What factors would have to play out for you to hit the high end of that and the low end of that? Thank you.
spk04: Yeah, hi, Steve. It's Jeff, and thanks for the question. I'll take the copay one. Look, I mean, some of the peers are seeing the effects of the so-called maximizer programs or even some of the lingering accumulator programs, which do sometimes, as benefit designs are reset in the first quarter, can apply some pressure. We don't see that. We've been managing that very tightly, and we're not seeing any significant sort of surge or creep in terms of that dynamic. The dynamic is exactly what Rob had highlighted. which is the modest price based on the number of indications and how fast the volume's moving and this destocking event that we talked through. So co-pay is very stable for AbbVie.
spk05: And C, this is Rob on your EPS range question. We've typically given a 20-cent range. This year we gave a 40-cent range, and the key driver of that is obviously the U.S. Humira Dynamics. As we see that play out, particularly in the second half, we would typically tighten that range. Now, keep in mind, You know, that 20 cent wider range represents about 1% of U.S. e-merit growth. So it's not as wide as you might think, but we did widen it given the dynamics with U.S. e-merit, and I think we'll be able to give you more color as we see those, you know, seven, nine biosimilars coming in the market in the middle of the year. We'll have more clarity for you on the second quarter call. Thank you.
spk09: Thanks, Steve. Operator, next question, please. Our next question comes from Chris Schott with J.P. Morgan. Your line is open.
spk19: Great. Thanks so much. Just coming back to Sky Rizzy and Renvoke, I think you mentioned high single-digit price erosion beyond just those inventory changes. I guess is that a reasonable assumption to think about price as we progress through the rest of this year? And then maybe longer term, should we think about that level of price erosion as more like a one-time kind of issue this year, given all the new indications and a more stable trend going forward? I'm just trying to kind of get my hands around the pricing a little bit more. And my second question was just on the aesthetics business. You obviously saw a very strong one cue. Can you just elaborate a little bit more on your confidence in the sustainability of these trends? I know the market's been a little bit bumpy, but it seems like the tone is that you're encouraged with the trends you're seeing. But just how much visibility do you have in terms of sustainability of those favorable international trends we're seeing right now? Thank you.
spk05: So, Chris, this is Rob. So on your question on price, yeah, the way to think about 2023 price for the year for SkyRise and RuneVote, would be down high single digits. Now, we wouldn't expect high single digits to be the rate going forward, given a big driver were the number of new indications that we launched. And so I would expect that to moderate over time.
spk13: Hi, this is Carrie. In terms of your questions around the aesthetics market, there are two key assumptions for the 2023 planning. One was around the US economy, and the other was around the recovery in China. You think about the US economy. we look at Q1 and we see some favorability to our planning assumptions with the metrics that we track, which Rob mentioned include real personal consumption expenditure and Google. So in January and February, we saw favorability there, although in March there are some potential signs of softening. So we continue to have a cautious outlook for our U.S. business for the rest of the year. The way to think about market growth for the full year would be for toxins, the market would be down low to mid-single digits until we lap the 2022 downturn, which happened around May. And then after that, we would expect flat market growth for the rest of the year. So that's how we think about the U.S. Our second biggest market is China. And recall, we had assumed that the aesthetics market in China would not fully recover until the second half of the year. Well, in actuality, what we saw was although January was significantly impacted. In February, we started to see improvement, and in March, there was a really steep recovery that we do expect will sustain through the rest of the year. And in other markets around the world, I guess in Canada and UK, we are seeing some high inflation impacting consumer demand, but the rest of Europe seems stable right now.
spk09: Thank you, Chris. Operator, next question, please. Our next question comes from Mohit Bansal with Wells Fargo. Your line is open.
spk14: Great. Thanks for taking my question. I have one clarification and one question. So clarification is regarding the price decline for I&I, you said that high single digit, but should we assume like going forward year over year versus volumes, should we assume high single digit decline still going forward at least for the rest of the quarters and then more stable pricing quarter over quarter term? Just that clarification. And the question is, Regarding the I&I pipeline, so you have a leadership position with Skyrise and Invoke, and they are growing, but some of the pipeline products like 154 and 157 did not pan out as you were hoping them to. So how should we think about the pipeline strategy beyond these two products? And can you even do M&A given the increased FTC scrutiny nowadays? Thank you.
spk20: So this is Rick. I'll cover number two and maybe just touch on number one. If you think about our pipeline, obviously as we look at Skyrizzy and RIMVOC, they clearly have restated the immunology market across most of the segments that we operate in. We view those assets as being able to drive strong growth through the early part of the next decade. Having said that, we're continuing to look for assets in areas where we believe there's still a significant opportunity to restate standard of care. And we obviously explore, as everyone in this industry does, many different assets and different mechanisms to try to find those kinds of mechanisms that will deliver that kind of performance. It's interesting, when you look at the 154 platform, it did exactly what we thought it would do from the standpoint of efficacy. But it did it in a way only at the highest dose, and at that highest dose we did see some effects of steroids on some of the biomarkers, and based on the way we think regulators would look at a label for those kinds of products, we didn't believe that would be a competitive profile. But the hypothesis certainly worked around the mechanism. We continue to look for opportunities. We have lots of runway here to be able to get to those, but we do desire to find some additional mechanisms that will be the follow-on products that should be introduced hopefully near the end of this decade or early into the next decade as the next generation immunology assets for AbbVie. And I feel good about the progress that we're making there. We're continuing to explore a number of other areas. and we're continuing to look both internally and externally at different assets that we can bring into the company to be able to do that. To your question of being able to bring assets into this market, we don't believe that we would be encumbered because immunology is a very crowded space from a competitive standpoint, and that's one of the most important criteria that you look at from an FTC standpoint. So we believe we have freedom to operate across most of those segments from an FTC standpoint as well. And on price, maybe Rob and I will tag team this one to make sure it's clear. It is common that when you go out and you add indications in this industry that when you negotiate those contracts to be able to get access, it does require some level of price concession. I would say we're on the lower end of what you typically would have seen with the speed at which we got access for Sky RISD and RINVOTE for those indications and the breadth of that access. And so you certainly would expect this year and last year to be the areas where you saw the most significant amount of price because those are the years that we had the majority of the indication. You would expect that to moderate. So then going forward, the way to think about it is then it's only really driven by volume at that point. And volume typically requires much more modest kinds of price as you go forward. It's not zero price. You shouldn't have that expectation. But I would not have an expectation of high single digits going forward.
spk05: Anything you'd add, Rob? Just to answer the question, Mohit, on the gating. Yeah, I think it's safe to assume that you'll see high single digit price in each of the quarters this year.
spk14: Helpful. Thank you.
spk10: Thank you. Mohit, operator, next question, please.
spk09: Our next question comes from Tim Anderson with Wolf Research. Your line is open.
spk01: Hi. Thank you for taking our questions. This is Alice Nettleton, author Tim Anderson. So a question on PBMs, which are under renewed scrutiny. If there were material changes to the rebating structure currently in place, would that put big incumbent products at risk because it might remove the so-called rebate wall, and more generally, do you think there is any chance of some of the proposed legislative changes actually becoming law? And then secondly, any collateral impact you're seeing on SkyRisi or RINVOC since Humira biosimilars have launched, given the overlapping indications, do you think that you'll start to see some picking off of patients from those two brands to biosimilars? in the second half of the year. Thank you.
spk04: Yeah, hi, it's Jeff. I'll give some comment on that. I think the way that we think about our brands is the first place that we look at is how distinctive they are. I mean, we've got four head-to-head trials with Skyrizzy and another one on the way where we can clearly differentiate the product. And we have many as well on Renvoke. So we've really thought about it from a development standpoint. And I would say, you know, The perspective is somehow there was a restructuring of the PDMs, which I don't think is imminent, and the rebate sort of approach disappeared. It disappears for everybody. I mean, all of these I&I products have a fairly reasonable rebate load, and there would be a different basis of competition, which we would do very, very well. So we're not concerned about you know, sort of a fundamental structural change relative to these two products, which are very distinctive. If we look at your second part of your question, which is it's really the same answer, which is we don't see that there are going to be significant impacts of Humira biosimilars on the performance of Skyrizzy and RINVOC. And one perspective, let's take RINVOC, is sort of a very simple way of thinking about it. It's already in the United States, a step behind TNF, and it's performing at that level because you see such expansion of second and third lines in that space. And Skyrizzy is very, very distinctive. So, no, in the second half, we do not anticipate sort of a knock-on effect of the emergent biosimilars to our two core brands.
spk09: Thanks, Alice. Operator, next question, please. Thank you. Our next question comes from Carter Gould with Barclays. Your line is open.
spk07: Great. Good morning. Thanks for taking the question. Maybe a different spin on sort of the B question there, just given sort of the volatility in the marketplace as you kind of have those conversations or engage with potential targets, just if you've seen a shift in sort of that that bid-ask spread and the willingness of boards and management to consider deals. Any updates on that front would be helpful.
spk20: This is Rick. I'd say the environment hasn't changed materially in the last 24 months from my perspective. I still think it's certainly more difficult to raise money for biotech companies, so it probably makes them a bit more willing. to engage with players like us or engage in a process if they're at a point where they've generated data that makes them attractive. But I'd say the interest level in that engagement is similar to what it has been for the last 12 to 24 months. And there's a lot of opportunity to be able to find assets that are in the biotech area The question is you have to find the right kind of asset and you have to find one that's attractive and it meets your needs. And I'd say being able to negotiate a transaction I think is a reasonable probability. I'd say prices are still relatively high. And so, you know, valuations for good assets tend to go at a pretty high level. So again, it's got to be an asset that can demonstrate that it's going to provide significant value to justify that kind of a valuation and a return. But we continue to look for opportunities, and I think as we find those kinds of opportunities, as I said in the past, we're certainly going to pursue them.
spk10: Thanks, Carter. Operator, next question, please.
spk09: Our next question comes from Vamo Devon with Guggenheim Securities. Your line is open.
spk12: Great. Thanks for taking the questions. Maybe a couple from me as well. So one, just a couple of data points you have coming up this year that I think may be a little bit less focused on is on Naviticlax and Teliso-V. So maybe you can just sort of frame what we should be looking for, what your expectations are, what you're hoping to see from those assets, especially Teliso-V, given your comments on the next-gen ABBV400. And then the other question, I guess, would be for Rick, more around succession planning. I know you mentioned before that your plans to stick around through the Humira event. I'm just wondering if you have any sort of updated sort of thoughts around timing on that now that we're sort of in the middle of this process. We've been getting some questions there, too. Is this something we should expect, some sort of announcement this year, or is it more, you know, you're looking sort of 2024 or later?
spk16: Thank you. Hi, it's Rupal.
spk06: I'll take the ones on Navidoclax and Taliso V. So for Navidoclax, that's the combination with the JAK2 and myelofibrosis. And there we're looking to be better than monotherapy with a JAK2 in that space and improving spleen size and symptoms like abdominal pain, fullness, fever, fatigue. Also, perhaps uniquely, what we've observed is also an improvement in bone marrow fibrosis and a decrease in variant allelic frequency. So that's what we would be looking for, and we should get a readout by mid-year or so. For Teliso V in lung cancer, EGFR wild type with high CMAT, and that's the indication where we have breakthrough therapy designation, Around the end of this year, I would say that's where we would see a readout. What we've seen in earlier data cuts is an ORR above 50%, which is quite a bit higher than what would be expected in standard of care in that second, third line setting. And if the data looks strong, there's a potential that we could submit next year for an accelerated approval.
spk20: I'll take the second question. And maybe I'll make a little bit of a comment on TelisoV, because I think you mentioned 400. I think the early data that we're seeing in 400 is impressive to us. There's no question about it. And I think we're going to have some data presented at this ASCO, right, where you'll have an opportunity to see that in CRC. Now, having said that, TelisoV, as Rupal said, does get very good responses in CMET highs. But to get a broader set of CMET population, we do believe you need to move to the topo warhead. It seems to get deeper responses and more durable responses. That data has to play out over time, but it appears to be a very good platform for CMET. And so we need the data to mature, and we need to develop more data in that area, but I'd say the early data is pretty encouraging. You'll have a chance to see a snippet of that at this ASCO. As far as leadership changes, I'd say it's similar to what we said in either first quarter or fourth quarter, I can't recall, last year around succession. We obviously have a process in place. We have a very experienced board. I've had many, many discussions with the board about succession. The board knows I'm committed to be here to ensure a successful and smooth transition. The criteria that we're operating against is we need to completely get through the transition for Humira biosimilars here in the U.S. I'd say so far I'm pretty pleased with how the transition is going, and I'm even more pleased with the way the growth platform is operating right now. And, in fact, if you look at it this year, The growth platform is going to deliver mid-single digits and is going to do it despite the headwinds that we see on Imbruvica and the headwinds that we're seeing from the economy on aesthetics. Once the aesthetics business returns to its normal growth rates and much of the pressure on Imbruvica starts to subside, we should see that growth rate increase significantly as we move into 24 for the growth platform. and obviously we're turning to robust growth in 25 and deliver high single digit from that point forward. So that's the expectation that we're working against. So we want to make sure that the business is operating the way we want it to. We want to make sure that we're through the biosimilar erosion to the point that we believe it is predictable. And then obviously the second part of the criteria is ensuring that the candidate that will succeed me is ready to do that, that we can make a successful transition. I've also told the board that I'm willing to stay in any capacity that they would desire for whatever length of time they would. I think the expectation right now is that I would assume the executive chairman role for a period of time to finish the transition to the new CEO. You should not be expecting that that transition is going to occur in 23.
spk10: Thanks, Fomal.
spk09: Operator, next question, please. Our next question comes from Evan Sigerman with BMO Capital Markets. Your line is open.
spk02: Hi, guys. Thank you so much for taking my question. Just on kind of SkyRizzy and some of the dynamics you're seeing there, can you characterize about kind of how you're thinking about further penetration in the psoriasis indication, kind of some puts and takes in the dermatology market? Just a follow-up on the CF program. Is it safe to assume that you're totally done investing in this area, or do you have other assets, kind of an earlier development that could emerge? Thank you.
spk04: Yeah, hi, it's Jeff. I'll take your comment on psoriasis. I think that, as I mentioned, the share is very, very impressive. So we have a 30% total market share now, which is really putting significant headroom against any other drug in that category by a lot. And one way to think about it is I think what you're asking is how much further can it run? And it can run quite a bit further to some degree if you think about it. So we're capturing on the dynamic share roughly 50%, so one out of every two patients. And our market share is about 30. So theoretically over time, right, unless there's some disruption, which we don't see significant disruption in the market, your total market share is going to move towards that in-play share. Now that takes many, many years, but as we look at the fundamental momentum that we can achieve, it's still very, very significant. Add on to that, that basically we're still, in the rest of the world, starting to really see the PSA ramp. And remember, PSA has a very significant impact, because it's treated by derms, and it was sort of the last remaining gap that we had. So you're going to see continued momentum in the international markets and the U.S. market, and we have a long way to run. And I'd be remiss if I didn't say how fast, again, that we're growing in both Crohn's right now and very exciting data in UC. And that market is very, very dynamic. So we feel very secure in our ability to continue to create a lot of value with SkyRizzy.
spk17: Hi, this is Tom, regarding the question on our triplet program. Our C2 corrector that we just tested did not work. This was not our first attempt at producing one, and we do not have another backup, so we don't have other options than to discontinue the CF program.
spk10: Thanks, Evan. Thanks, Evan. Operator, next question, please.
spk09: Thank you. Our next question comes from Chong Wen with Credit Suisse. Your line is open.
spk15: Hi, good morning. This is Carson for Tron. Thanks for the question. Just on Imbruvica, how confident are you for the 5.7 T-Monk guide, given the significant competitive pressures there? I mean, I understand McKinsey did particularly have legs in the U.S. until late January. What level of pricing pressures can we expect through the year? And is there the potential for further step-downs in your guide for later in the year? And if you do do that, could the trough be pushed out, given the delay with 951 as well? Thanks.
spk04: Yeah, hi, it's Jeff. And, you know, I think we think that's a very good call. And just as a reminder, we're not seeing significant pricing pressure in the market. This is really two effects, which is one, the cumulative effect, as we've highlighted over the suppressed market over time, which looks to be normalizing. Actually, for the first time in three years, we actually saw a positive growth in the market. So that's encouraging. The big driver is the share, is the new patient share, which has been under pressure, initially under pressure by Calquence, certainly from our own Venclexta, and then the recent Brukinza launch. And so when we put all of that into the calculus, we think we've got it right, and it's probably unlikely that we're going to see, you know, any significant step down that would put that in jeopardy.
spk05: Carson, this is Rob. I'll answer your second question. So I wouldn't consider Imbruvacan 951 to be variables that would push the trough out. It's really more about how the overall year plays out, particularly the second half with U.S. Humira. So if U.S. Humira does better and we outperform in 23, then we could see the trough in 24. I think the important thing to keep in mind is regardless of when the trough occurs, we wouldn't expect earnings to fall below the 1070 floor XIPRD. That's really what I would focus on. And we don't consider Imbruvica and the 951 delay to be variables that would push that trough.
spk10: Thanks, Carson. We were cognizant of a number of peers reporting today, and so in the interest of time, we have time for one last question.
spk09: Our last question comes from Jeff Meacham with Bank of America. Your line is open.
spk11: Hi, this is Susan on for Jeff Meacham. We had a follow-up on Imbruvica earlier. Do you guys expect any changes to Outlook following MCL-MZL withdrawal? And then do you expect any read-through to follicular lymphoma from that withdrawal?
spk04: Yeah, hi, it's Jeff. Thank you for the question. First, these are very small indications. So to give you some sense of the relative size for Imbruvica, MCL is about 4% of the value. really less than a percent, about a percent. So we don't anticipate that those withdrawals, due to the fact that we didn't get the confirmatory studies to clear, will have a material impact. I think it's also important to note that many physicians will continue these patients on the medication. They won't be all switched, for example, or taken off and put on another product. That's the market intelligence. There's no requirement that they need to do that for the physicians. And so net-net, this is not a really material issue given the size of those indications. And I think Rupal will address your point on follicular.
spk06: Yeah, I can talk about FL here for a minute. So a Phase III readout is expected later this year. It's not clear if the MCL outcomes would... be reflected in what we see there. But what I would say about FL is, you know, our focus would be with Epco, Ritamab, or Dual Engager, which we expect DLBCL actions here soon. And then we have programs, and we're seeing very high levels of response in FL with Epco, either as monotherapy or in combinations, which we'll see some data in those combos in DLBCL and FL at ASCO as well.
spk10: Thanks, Susan. And that concludes today's conference call. If you'd like to listen to a replay of the call, please visit our website at investors.abdi.com. Thanks again for joining us.
spk09: Thank you for your participation. Participants, you may disconnect at this time.
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