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spk18: Good morning and thank you for standing by. Welcome to the FV First Quarter 2024 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 of Investor Relations. Ma'am, you may begin.
spk14: 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, President and Chief Operating Officer, Jeff Stewart, Executive Vice President, Chief Commercial Officer, Scott Rentz, Executive Vice President, Chief Financial Officer, Carrie Strom, Senior Vice President, AbbVie and President, Global Allergan Aesthetics, and Rupal Thakkar, Senior Vice President, Chief Medical Officer, Global Therapeutics. Joining us for the Q&A portion of the call is Tom Hudson, Senior Vice President, Chief Scientific Officer, Global Research. Before we get started, I'll note that some statements we make today may be considered forward-looking statements based on our current expectations. Abby cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in our forward-looking statements. Additional information about these risks and uncertainties is included in our SEC filings. AbbVie undertakes no obligation to update these forward-looking statements except as required by law. On today's conference call, non-GAAP financial measures will be used to help investors understand AbbVie's business performance. These non-GAAP financial measures are reconciled with comparable GAAP financial measures in our earnings release and our 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.
spk02: Thank you, Liz. Good morning, everyone, and thank you for joining us today. I'm extremely pleased with our start to 2024, with first quarter results exceeding our expectations. Before we discuss our performance in more detail, I'd like to share my perspective on the planned CEO transition that was announced earlier this year. After serving more than 11 years as AbbVie's first CEO, I have decided to retire from the role effective July 1st of this year and will continue to serve AbbVie as Executive Chairman of the Board. As you heard me say before, it is important that we choose the right time to make this critical leadership transition. The Board and I have been long planning for my eventual succession, and now is the opportune time to move forward with the transition, as our business is performing very well and is in a strong position for the long term. We are successfully navigating the Humira U.S. loss of exclusivity. We have built an outstanding company culture, an important priority and competitive advantage. And our productive R&D engine, which has yielded numerous innovative new medicines for patients, will continue to fuel our robust pipeline for years to come. After a multi-year process, our board has unanimously selected Rob Michael, our current President and Chief Operating Officer, as AbbVie's next CEO. I have known and worked with Rob for many, many years and he is an excellent choice as my successor. He brings the experience, the leadership, and the strategic vision to build on AbbVie's past successes, advance our strategy, and enhance shareholder value. Since our inception, Rob has held several important leadership positions that have collectively had a tremendous impact on AbbVie. from establishing our financial planning organization to navigating the end of exclusivity for Humira in the U.S. to driving key business development opportunities that have been critical to diversify our business and support long-term growth, including the acquisitions of Allergan and Immunogen and the pending Cereval transaction. Looking back, AbbVie has evolved tremendously as an independent company. and our performance has truly been exceptional. Since our inception, we've grown our revenue from $18 billion to $55 billion. Our market capitalization has increased substantially from $54 billion to roughly $300 billion today. We have achieved a total shareholder return of more than 675 percent, which is top tier relative to our peers. And importantly, we have substantially increased our investments in R&D to discover and develop new medicines that have the potential to improve the lives of patients. As I look ahead, our company has never been stronger, and our future has never been brighter. We are executing well across all aspects of our business, and our long-term growth prospects remain very strong. In summary, It has been a privilege and immensely gratifying to serve with all of my AbbVie colleagues for the past 11 years, growing AbbVie into what it is today. And I look forward to continuing to work with Rob and the leadership team to create meaningful value for our shareholders and all of our stakeholders. And I'd also like to take this opportunity to thank all of our shareholders for the trust and confidence you put in me as AbbVie's CEO. With that, I'll turn the call over to Rob for comments on our recent business performance. Rob? Thank you, Rick.
spk10: Before I comment on our first quarter performance, I want to congratulate Rick on his exceptional leadership of AbbVie over the past 11 years. During his tenure, Rick made several strategic moves that have positioned AbbVie to have a bright future beyond Humira, consistently drove the organization to deliver very strong performance, and demonstrated the genuine care for our employees patients, shareholders, and communities that has defined who we are as a company today. It has been my privilege to work closely with Rick over many years and I look forward to working with him in his role as Executive Chairman. Avi's outlook is very strong and I am excited about the remarkable impact that we will continue to have on patients' lives. During the first quarter performance, we're off to an excellent start to the year. with strong top and bottom line results. We reported adjusted earnings per share of $2.31, which is 11 cents above our guidance midpoint. Total net revenues were $12.3 billion, approximately $400 million ahead of our expectations. This overachievement was driven by our ex-Humira growth platform. which delivered revenue growth of more than 15% this quarter and includes continued robust sales from SkyRizzi and Rynvoke, with combined growth above 50% in their fifth full year on the market, as well as double-digit revenue growth from several other key products, including Venclexa, Vralar, Ubrelvi, and Qlypta. This broad-based sales momentum clearly demonstrates the strength of our diversified portfolio, with multiple growth drivers to support our long-term outlook. We are also making excellent progress with several of our near-term priorities. We recently completed the acquisition of Immunogen, which accelerates our entry into the solid tumor market and strengthens our oncology pipeline. The integration has been seamless, and we are impressed by the caliber of talent we have welcomed into AbbVie. We also remain on track with the pending acquisition of Cereval, which we anticipate will close in the middle of the year. Cereval's pipeline of differentiated assets will further augment our neuroscience portfolio. In addition, we continue to advance our R&D pipeline and invest for long-term growth. This progress includes the FDA's full approval of Eliher for FR-alpha positive, platinum-resistant ovarian cancer. a meaningful first-in-class treatment for patients, and a significant long-term growth opportunity for AbbVie in solid tumors. We also gained U.S. approval of Juvederm Voluma XC for Temple Hollows, further strengthening our leadership and aesthetic fillers. And we executed several business development opportunities, adding novel early-stage programs and partnerships in oncology and immunology. Given the strong results this quarter, we are raising our full year adjusted earnings per share guidance by 16 cents, and now expect adjusted EPS between $11.13 and $11.33. In summary, this is an exciting time for AbbVie, and I am extremely pleased with the momentum of our diverse portfolio. We're off to an excellent start to the year, and we are well positioned to deliver a high single-digit revenue kegger through the end of the decade. With that, I'll turn the call over to Jeff for additional comments on our commercial highlights. Jeff.
spk07: Thank you, Rob. I'll start with the quarterly results for Immunology, which delivered total revenues of approximately $5.4 billion, exceeding our expectations. Guy Rizzi global sales were $2 billion, reflecting operational growth of 48%. We continue to see exceptional momentum across all of the approved indications. In psoriasis, Guy Rizzi is the clear market leader in the US biologic psoriasis market, with a total prescription share now above 35%. That's more than double the share of the next closest biologic therapy. Share is also ramping nicely in PSA, especially in the dermatology segment, where we are now capturing one out of every four new or switching in-play biologic patients. Globally, Skyrizzy has achieved psoriatic in-play share leadership in nearly 30 key countries. In IBD, Skyrizzy is on track to add more than $1 billion of incremental sales growth this year. We are seeing tremendous performance in Crohn's disease, where our compelling head-to-head data versus Stelara is driving a meaningful inflection of patient share. As a result, we have now achieved in-place share leadership in Crohn's across all lines of therapy in both the US and Japan, as well as other key markets around the world. And finally, we are preparing for the launch of Skyrizzy and ulcerative colitis, which represents another substantial long-term growth driver. We expect approval decisions in the middle of this year, and anticipate rapid access in the U.S. following our launch. Given the robust frontline capture for Skyrizzy and Crohn's, and the exceptional bio-naive data we have generated in UC, we anticipate a strong launch. Turning now to RINVOQ, with global sales of approximately $1.1 billion, reflecting operational growth of 61.9%. In ROOM, we continue to see strong prescription growth across each of the four approved indications, And I'm especially pleased with our performance in rheumatoid arthritis, where RINVOC has achieved in-play share leadership in nearly 20 key international markets. Atopic dermatitis is tracking in line with our expectations with continued market share momentum globally. Importantly, we recently announced positive results from Level Up, our second head-to-head study in A.D., Level Up demonstrated Renvoke's superiority for patients starting therapy on the 15 milligram dose versus Dupixent across key efficacy parameters, including the high levels of skin clearance and itch reduction. We anticipate these strong head-to-head results will support additional share capture, especially given Renvoke's label use in the U.S., which requires that initiation with a 15 milligram dose. And in IBD, RINVOC's uptake continues to be very strong. RINVOC is capturing high teens in play patient share in ulcerative colitis, as well as mid-teens in play patient share in Crohn's disease. This performance is especially encouraging, recognizing that we're still relatively early in the launch phase for both the UC and CD indications. And the lines of therapy are also expanding, with second line plus growing even faster as patients cycle to newer, higher-efficacy agents, like RINVOC and IBD. Turning now to Humira, which delivered global sales of approximately $2.3 billion, down 35.2% on an operational basis, due to biosimilar competition. Erosion in the U.S. played out slightly better than our expectations in the quarter, with the vast majority of the impact this quarter driven by price. As previously communicated, the recent changes to the CVS template formularies were anticipated in our full year outlook for U.S. Humira, and the volume impact is tracking in line with our expectations. Our guidance has also contemplated the impact of additional formulary changes that are expected to go into effect over the course of the year. We continue to anticipate that Humira will maintain parity access to biosimilars for a significant majority of patient lives this year. Moving now to oncology, where total revenues were more than $1.5 billion, exceeding our expectations. In Bruvica, global revenues were $838 million, down 4.5%, reflecting continued competitive pressure in CLL. Benclexta global sales were $614 million, up 16.3% on an operational basis. and we are seeing robust momentum internationally with strong performance for both CLL and AML. Elihir generated $64 million of sales to AbbVie, reflecting a partial quarter of revenue following the February close of the Immunogen acquisition. The Elihir sales and marketing team is executing very well, and I'm pleased with the smooth integration into our commercial organization. We anticipate that the recent positive updates in the NCCN guidelines for both platinum-sensitive and platinum-resistant ovarian cancer patients, as well as the full label approval, which of course includes the compelling overall survival data that has never been achieved before in these platinum-resistant patients, will continue to drive strong Eliher uptake. Lastly, the global launch of Epkinley in third-line plus DLBCL is also performing well, and we remain on track for the potential label expansion for follicular lymphoma later this year. Neuroscience total revenues were nearly $2 billion, up 16% on an operational basis, again, ahead of our expectations. This robust performance is driven by continued double-digit growth of Braylar, with global sales of $694 million, Ubrelvi, with total revenue of $203 million, and Qlypta, with global sales of $131 million. Each of these leading assets continue to gain share and remain competitively well-positioned. Botox Therapeutic is also performing well, especially in chronic migraines. Total global sales were $748 million, up 4.5% on an operational basis. And finally, we are very excited about 951, which will be commercialized as VIALEV in the US and represents a potentially transformative next generation therapy for advanced Parkinson's disease. Feedback from the launches in Japan and Europe have been very encouraging, and we remain on track for commercial approval in the U.S. later this year. So overall, I'm extremely pleased with the strong and balanced growth across our therapeutic portfolio this quarter, a testament to our differentiated product profiles and commercial execution. 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 over $1.2 billion, reflecting a modest decline on an operational basis. In the US, aesthetic sales of $776 million were roughly flat versus the prior year. We continue to see sustained momentum in the facial injectable market recovery that emerged in the back half of last year. Consistent with the past few quarters, the toxin market grew by a mid single digit percentage. We saw similar year-over-year increases in the number of facial filler procedures, representing a return to quarterly market growth for the first time since early 2022. From a competitive perspective, our U.S. aesthetics portfolio continues to perform well. Market share for both Botox Cosmetic and Juvederm was stable in the first quarter as these assets remain the clear market leaders. While we're pleased that the market and share trends across U.S. facial injectables are aligned with our previous expectations, our first quarter results were impacted by customers holding lower than normal inventory levels at quarter end. This dynamic relates to a decision made during the quarter to shift the timing of certain promotional activities into the second quarter. We therefore expect inventory levels to normalize in the second quarter and remain on track to deliver full-year aesthetic sales growth in the U.S. Internationally, first quarter aesthetic sales were $473 million, reflecting an operational decline of 5.5%. Consistent with our expectations, growth in China was impacted by persistent economic headwinds, as well as a challenging comparison versus the first quarter of last year, which benefited from a robust recovery post-COVID. We are monitoring the economic developments across China and continue to anticipate a recovery in the second half of this year. Our pipeline continues to generate important new assets. Uptake of our recently launched Volux and Skinviv products remains strong, underscoring the importance of innovation within aesthetics. Given this context, we are excited for the upcoming launch of Juvederm Voluma XC for the treatment of temple hollows. As the only HA dermal filler approved for use in the upper face, we anticipate the Voluma XC introduction will activate more consumers and support the long-term growth of our filler portfolio. And within our toxin pipeline, we continue to expect FDA approval of the platysma prominence indication for Botox near the end of this year, enhancing Botox growth potential as a non-invasive treatment to reduce the appearance of vertical neck bands and improve jawline definition. We also remain on track to submit a new drug application for our short-acting toxin, Bonti, before the end of this year. This novel toxin has demonstrated a rapid onset of action as well as a short duration of effect. meaningfully lowering the barrier for toxin adoption across consumers who have been considering but hesitant to try Botox. Given this profile, Bonte has significant market expansion potential, as satisfied patients would naturally convert to Botox. Overall, the underlying trends across our aesthetics portfolio align well with our previous expectations, and we remain on track to deliver high single-digit global aesthetics growth this year. With that, I'll turn the call over to Rupal.
spk11: Thank you, Carrie. I'll start with immunology. We recently announced positive top-line results from two Phase III studies for RINVOC in dermatology and rheumatology. In the level-up study, which evaluated RINVOC against dupilumab in atopic dermatitis, RINVOC demonstrated superiority on the primary endpoint at week 16, which was a composite endpoint measuring skin clearance and itch reductions. Twice as many RINVOQ patients achieved this very stringent endpoint compared to dupilumab. RINVOQ also demonstrated superiority on all rank secondary endpoints in this trial. Level Up was a study in which patients started on RINVOQ 15 milligrams and could escalate to 30 milligrams if they did not achieve treatment goals, which is how RINVOQ is prescribed for atopic dermatitis in the U.S. We also saw very rapid responses with RINVOC demonstrating superiority on itch as early as week two and on skin lesions as early as week four. RINVOC's safety profile in the level-up trial was consistent with what has been observed in previous studies. There were no serious infections in patients treated with RINVOC and one in the dupilumab group. The rate of serious adverse events was similar across treatment arms. There were no malignancies, MACE events, or VTEs reported in either treatment group. Based on these data, as well as results from previous phase three studies, we remain very confident in RINVOQ's profile in atopic dermatitis, and we believe it offers meaningful advantages over other products on the market today. We also announced positive top line results from our Phase III Select Giant Cell Arteritis Trial, which evaluated RENVOC in combination with a 26-week steroid taper regimen compared to patients receiving placebo in combination with a 52-week steroid taper. In the study, RENVOC 15 milligrams met the primary and key secondary endpoints, demonstrating superiority on sustained remission from week 12 through week 52, as well as on disease flare and reduction in cumulative steroid exposure at week 52. Importantly, RINVOQ's safety profile was consistent with what has been observed in more than 15,000 patients previously studied across controlled trials. The mean age in this population was 71, which is the oldest population studied to date with RINVOQ. and the average prednisone equivalent dose at baseline was almost 35 milligrams. Rates of serious adverse events and VTEs were similar across treatment groups. There were no MACE events in the RINVOC arm, while there were two in the placebo group. Based on the results from the select GCA trial, we believe RINVOC has the potential to be a safe and tolerable oral treatment option. We plan to submit our regulatory applications for this indication later this year. We continue to make very good progress with our inflammatory bowel disease programs. We anticipate several advancements this year, including the initiation of a Phase II study for ludicizumab and ulcerative colitis, the start of our Phase II Crohn's disease platform study, which will evaluate combinations of Skyrizzy with ludicizumab and other novel biologics. And we remain on track for approval decisions for Skyrizzy in ulcerative colitis, with the U.S. expected in the second quarter and Europe in the second half of the year. We also continue to invest in external innovation to expand our immunology pipelines. as evidenced by four deals that we announced in the first quarter. These include the acquisition of Landos Biopharma, which brings an oral NLRX1 agonist, currently in phase two for ulcerative colitis. A partnership with OC Immunotherapeutics to develop a novel ChemR23 agonist antibody for inflammatory conditions, such as IBD and RA. a collaboration with Parvus Therapeutics to utilize their immune tolerization platform to develop novel therapies for IBD, and a collaboration with Tenterix Biotherapeutics to develop conditionally active multispecific biologics in immunology and oncology. We are excited to partner with these companies who are all pursuing very innovative approaches to developing transformative therapies Moving to oncology, we're in the quarter we closed the immunogen transaction, which brings exciting programs in both solid and blood cancers. Last month, Elahir received full approval from the FDA for FR-alpha positive platinum resistant ovarian cancer in patients treated with up to three prior therapies. This conversion to full approval was based on data from the confirmatory phase three Mirasol trial. where Elihir demonstrated an overall survival benefit and significantly reduced the risk of cancer progression. We expect to see results from additional immunogen programs this year, including data from the Phase II Piccolo study evaluating Elihir as a monotherapy in FR-alpha positive, third line plus, platinum sensitive ovarian cancer patients who are not eligible for retreatment with platinum-based therapies. And we expect to see data in the second half of the year from a potentially registration-enabling Phase II trial for our CD123-targeting ADC, PIVAC, in a rare blood cancer called blastic plasmacytoid dendritic cell neoplasm. Now moving to program updates in hematologic oncology. Based on the totality of the data from our Transform1 trial, and following recent feedback from regulators, we will not be submitting neviticlax for approval in myelofibrosis, and we will wind down the TRANSFORM2 study in the relapsed refractory setting. In other areas of EMOC, we remain on track for several regulatory and clinical milestones this year, including regulatory approvals in the US and Europe for a Kinley in relapsed refractory follicular lymphoma, the Phase III readout from the Venclexta-Verona trial in treatment-naive, higher-risk MDS, and initiation of a Phase III monotherapy study for ABBV383 in third-line multiple myeloma. We remain very excited about this asset's potential to become a best-in-class BCMA CD3 bispecific by providing deep, durable responses and low incidence and severity of CRS, with the potential for outpatient administration, limited or no step-up dosing, and monthly administration from the beginning of treatment. Moving to other areas of our pipeline. In aesthetics, we remain on track to submit our regulatory application for Bonte in the second half of the year. Our rapid-onset, short-acting toxin as a highly differentiated clinical profile compared to currently available neurotoxins. Bonti is designed for patients that are considering using facial toxins for the first time or for a special event and will allow them to experience results over a very short period of time. This novel toxin will complement our existing business as patients would naturally transition to Botox following experience with this trial toxin. And in neuroscience, we continue to make good progress with 951, where we have received regulatory approvals in 33 countries thus far and anticipate an approval decision in the U.S. in the second quarter. As Rob mentioned, we remain on track to close the Cerevel transaction in the middle of this year. Ceravel recently announced positive top-line results from their Phase III TEMPO-III trial evaluating Tavapidon as adjunctive therapy to levodopa in patients with Parkinson's disease. In the study, Tavapidon met the primary endpoint, demonstrating a 1.1-hour increase in total on time without troublesome dyskinesia compared to patients treated with levodopa and placebo. Tavapidon also met the key secondary endpoint in the trial, providing a significant reduction in off-time compared to levodopa and placebo. Two additional Phase III studies for Tavapidon in Parkinson's disease are expected to read out later this year. The amiraclidine pivotal studies in schizophrenia remain on track to begin reading out later this year as well. We look forward to providing updates on these programs once the transaction has closed. With that, I'll turn the call over to Scott.
spk04: Thank you, Rupal. Starting with our first quarter results, we reported adjusted earnings per share of $2.31, which is 11 cents above our guidance midpoint. These results include an 8-cent unfavorable impact from acquired IP R&D expense. Total net revenues were $12.3 billion, $400 million ahead of our guidance, and reflecting a return to growth of 1.6% on an operational basis, excluding a 0.9% unfavorable impact from foreign exchange. Importantly, these results reflect more than 15% sales growth from our Exumera growth platform. The adjusted operating margin ratio was 42.2% of sales. This includes adjusted gross margin of 82.9%, adjusted R&D expense of 14.7%, acquired IP R&D expense of 1.3%, and adjusted SG&A expense of 24.6%. Adjusted net interest expense was $429 million. The adjusted tax rate was 14.8%. Turning to our financial outlook, we are raising our full year adjusted earnings per share guidance to between $11.13 and $11.33. This increase of $0.16 at the midpoint includes $0.26 of operating overperformance partially offset by $0.10 of higher dilution due to the earlier close of Immunogen. As previously communicated, This earnings per share guidance includes 42 cents of dilution related to the recently closed acquisition of Immunogen and the pending acquisition of Cerevel. Please also note that this guidance does not include an estimate for acquired IPR&D expense that may be incurred beyond the first quarter. We now expect total net revenues of approximately $55 billion, an increase of $800 million. At current rates, we expect foreign exchange to have a 0.9% unfavorable impact on full-year sales growth. This revenue forecast includes the following updated assumptions with the entire sales increase driven by our Exumera growth platform. We now expect Sky RISD global revenue of $10.7 billion, an increase of $200 million due to strong momentum across all approved indications. Renvoke total sales of $5.6 billion, an increase of $100 million, reflecting robust uptake in IBD. In Bruvica, total revenue of $3.1 billion, an increase of $200 million, reflecting lower erosion. And El-Lahir total sales to AbbVie of $450 million, an increase of roughly $200 million, reflecting a partial year of revenue following the February close of the Immunogen acquisition. Moving to the P&L for 2024, we continue to forecast adjusted gross margin of approximately 84% of sales, adjusted R&D investment of 14%, adjusted SG&A expense of 23.5%, and an adjusted operating margin ratio of roughly 46.5%. We now expect adjusted net interest expense of $2.2 billion, which includes the partial year cost in 2024 to finance the Immunogen and Ceravel transactions. Turning to the second quarter, we anticipate net revenues of approximately $14 billion, which includes U.S. Humira erosion of approximately 32%, reflecting a step up in volume erosion with the recent CVS formulary change, partially offset by a one-time price benefit also associated with that change. At current rates, we expect foreign exchange to have a 1.3% unfavorable impact on sales growth. We are forecasting adjusted operating margin ratio of approximately 49.5% of sales, and we are also modeling a non-GAAP tax rate of 16.4%. We expect adjusted earnings per share between $3.05 and $3.09. This guidance does not include acquired IPR&D expense that may be incurred in the quarter. In closing, I'm very pleased with the excellent start to the year. We are demonstrating strong momentum across the portfolio and our financial outlook remains very strong. With that, I'll turn the call back over to Liz.
spk14: 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.
spk18: Yes, the first question comes from Mohit Banzal with Wells Fargo. Your line is open.
spk17: Great. Thank you very much for taking my question, and congrats on the progress, and congrats to all as well. So maybe let's just start with 2024. I mean, so thanks for this guidance. But when we look from 2024 to 2025, there are a couple of headwinds that you have highlighted in the past. So obviously IRA, Part D redesign would be there. And Humira may have another leg down. And given the volume erosion here, people are a little bit concerned there. Can you help us understand that what is your current thinking on the trough 24 versus 25, and could you give us some confidence that you can continue to grow in 25 despite these headwinds from IRA and HMARA? Thank you.
spk10: So Mohit, this is Rob. I'll take that question. So if you think about 24 and 25, I mean, clearly the exumeric growth platform is demonstrating great momentum. If you just think about SkyRizzi and RIMBOK alone are growing by more than 4 billion per year. Aesthetics will recover to high single-digit growth. Our neuroscience franchise will grow by over $1 billion this year on the heels of strong momentum from Braylar and our migraine portfolio, and we will have incremental contributions from ViaLev and Eli here in 25. So we have several drivers that will offset human erosion next year as well as the Part D benefit redesign impact and allow us to still deliver robust revenue growth. When you think about that redesign impact, it will really spread across our business, most concentrated in immunology and oncology. And we would estimate that that total revenue impact could be worth several points of growth. While we will still deliver robust revenue growth, we will have that headwind in 25. But keep in mind for us, the IRA impact really hits us in 25 and isn't a significant headwind in the years that follow as products that are subject to negotiation will not have that Part D cost share impact. So the way to think about it is despite that headwind in 25, we will still deliver robust growth with that growth rate accelerating in the years that follow. And then if you think about on a margin perspective, we're going to continue to expand operating margins, so that will be a tailwind. You should be, though, modeling annualization of interest expense from these transactions, and keep in mind that we essentially would have, you know, think of it as roughly a half year for Cerevol and 10 and a half months this year for Immunogen. So that should be something that you do model for 2025. So we'll have robust revenue growth. we'll have earnings growth not quite at the rate of the revenue growth because of that analyzation impact, but then when you get to 26 and beyond, you have even faster revenue growth and very robust earnings growth. So that's probably the best way to think about the profile of the company. But when you look at that ex-humana growth platform, there's a lot of momentum there, and we are very well positioned to deliver very robust growth.
spk17: Super helpful. Thank you.
spk14: Thanks, Mohit. Operator, next question, please.
spk18: The next question is from Vimal Devon with Guggenheim. Your line is open.
spk16: Great. Thanks for taking the question. So maybe I could just ask a couple on the aesthetics side. It sounds like your commentary is pretty generally in line with what you said before, but obviously the number was a little lighter this quarter than even your guidance and what people are expecting. So can you maybe just talk a little bit more about that? You mentioned some shift in promotional efforts to the second quarter and Maybe inventory levels then as a result being lower, and maybe I don't know if you can quantify that a little bit. Was this sort of planned when you gave your guidance back in February, or is this something that sort of evolved over the course of the quarter, and maybe just kind of why the decision was made would be helpful to give us some comfort on the outlook there? Thanks.
spk13: Hi, this is Carrie. Thanks for the question. First, I'll give a little bit of context to the fundamentals in terms of market growth and market share, which were in line with our expectations. So our market share continues to be strong and stable for Botox Cosmetic, despite a new competitor, strong, stable share at high levels. And then for our Juvederm line, continued share strength, even some share pickup in the in the past few quarters as we launch our new products. So like you said, those fundamentals are in line with our expectations. As we were going through the quarter, we really realized that, you know, the aesthetics market is quite sensitive to seasonality, with Q2 and Q4 typically having the highest volume. And after a few years of COVID and economic disruption, we're now anticipating a return to that typical seasonality. So, we shifted investment in some of our sales and marketing efforts into Q2, which impacted customer and sales promotional timing and activities, which then resulted in lower inventory held by our customers in Q1. And we do expect that to come back in Q2 and the rest of the year. And I'll let Scott address the rest of that question.
spk04: Sure. Thanks, Carrie. So, Bumble, to quantify the inventory impact in the first quarter, it was a little bit more than $50 million between Juvederm and Botox. And you can think of that as being split roughly two-thirds to Botox and one-third to Juvederm. And I think as Carrie mentioned in her remarks, that impact to that inventory, we expect that to turn in the second quarter.
spk14: Thanks, Vamil. Operator, next question, please.
spk18: Yes, our next question comes from Chris Shibutani with Goldman Sachs. Your line is open.
spk21: Great. Thank you very much. Good morning. When we think about the 2024 upcoming contracting season, which obviously has been quite dynamic for Humira over the past year plus, can you provide us with any insights in terms of structural aspects within your contracts that you build in that may help provide offsets? We often have limited visibility. We're looking at the prescription volume trends. and it feels as if our calculus is sometimes incomplete. But what can you reassure us in terms of the dynamics as we're seeing this year two play out and how you're approaching contracting for the forward? Thank you.
spk07: Yeah, hi Chris, it's Jeff. So, you know, the contracting season typically starts, you know, April or May, and frankly, as we've highlighted before, it can run in the immunology category really through the end of the year. So we have a few philosophies that we look towards, which are we want to continue to basically make sure that patients, if possible, based on our pricing concessions, aren't disrupted. Because when you start to disrupt patients, they do struggle with the change. It's a change in their treatment course. And so as we look to that, we've historically highlighted that we are negotiating for parity contracts with Humira. And we do put some controls in place in some cases, but not all. We seek multi-year contracts with our payers to try to establish the relationship, the pricing, et cetera. And we will think of ways to make sure that those contracts can hold so they have some teeth in them. They can't just be you know, willy-nilly discarded. And so it is a long-term, in some cases, partnership over a couple of years with these payers. You know, I can't go into the details over exactly how those controls work, but suffice it to say that there's terms and timing and, you know, limits in terms of when contracts can be changed, even maybe some clawbacks in some cases. So because we want these more sustained relationships because of our position in the in the category with these great brands, we typically use those sort of techniques, and that's how we go for it. So again, it's hard to look forward too much because it is dynamic as we look to 25, but we've been quite successful in maintaining good access for our brands, and certainly Humira is tracking in line with our expectations.
spk14: Thanks, Chris. Operator, next question, please.
spk18: Our next question comes from Chris Schott with J.P. Morgan. Your line is open.
spk03: Great. Thanks so much. Just a couple more on the Humira front. Again, Humira, you had mentioned that in 2024 you expected most of the impact would be price versus volume, but I think the street's been concerned. They were seeing more volume erosion, particularly with the CVS book of business. I'm just interested in your latest thinking as we think about price versus volume for the remainder of this year as we consider CVS, Cigna, etc., How should we think about that balance just so there's kind of no surprises as I guess we watch these volume trends playing out? And then maybe just in a related topic, can you talk at all about the tail for Humira sales in the U.S.? I guess the heart of the question, do you expect that you'll see most players or payers eventually switch out Humira like we're seeing at CVS? And if so, is it still reasonable to think about there being a kind of a decent tail of revenue, I guess, for this product in the U.S. over time? Thanks so much.
spk07: Yeah, great question. There's a lot in there. Let me go through it in a systematic fashion. So I think first, to directly answer your question, we still, as we look forward, believe that the significant majority of our lives will be at parity. So that means our guidance around the majority being price is still holding in our go-forward look. Let me give you some perspective. I had some in my opening remarks over what's happening with CVS. So the first is that, as I mentioned, the step down in volume was really anticipated, and based on our analysis of the data, which I'll highlight, it's really right in line with our expectations. Now, one of the things in my remarks I often talk about, you know, new to brand or in-place share capture, and that's a really good way to look at performance, particularly early in launch cycles when you're when you're looking at capture rate or competitive dynamics. I think it's important that investors and analysts need to be very mindful when you have a dislocation or disruption or switching. You can get very, very fooled at looking at NRX or NBRX because it sort of over inflates what you might be looking at. So I think that's important. The other fact base that we look at is in terms of the step down. is we look at other analogs, and we look at the Cosentix-TALTS analog, or TALTS was advantaged in ESI for Cosentix back in 2019, and we see that typically in this category, almost 90% of the erosion tracks within the first two to three weeks, and that's actually what we're starting to see, we believe, with the CVS template following that similar pattern. So if you can't really look at NRX or MBRX, you really have to look at TRX in this case, Chris. And this is very interesting. And we would make sure to guide folks to look at what's happening with the TRX data in the market. And what we see is that not all of the Humira prescriptions are moving to a biosimilar. And if you look at the first two weeks, it's pretty meaningful. Over 20% of the Humira prescriptions are moving to other mechanisms of action, including Skyrizzy and Rynvoke. And in fact, while we haven't studied this week as much, it actually seems to have accelerated a bit from there. And that actually makes some sense, because if you think it from the physician's perspective, when patients are being switched, they often take a break and a pause to say, are these patients really under control? Should I consider an alternative? And that's actually what we see playing out in the market. So the pure... Degradation or step down from Humira is in line what we see, but we are seeing a fairly significant move to other mechanisms, as I mentioned, including our own Skyrizzy and RINVOC. And that could be very, very good for patients who are probably getting better care for control of their disease. Now, having said that as well, if we look through the rest of 24, we have very solid contracts with our payers through 2024. And remember that these payers can add biosimilars at parity whenever they choose. We saw that last year in the middle of the year, and that's really not different now. So when we look at the structure and controls of our existing agreements, we do not see widespread exclusions for the rest of the year as we go forward. And so I think we've been pretty consistent with that. that select clients will move towards biosimilars over the course of the year. Last year we saw that with Kaiser and Medicaid plans. We've talked about the CVS exclusion for the template business. And we do see that some select plans may take another approach, which we've contemplated as the year goes on, which is they may move new patients to the biosimilar but maintain the large existing base. and that's quite manageable because really only about 14% or 15% of the patients are new patients that cycle into Humira. So overall, that's our perspective. We're confident. Things are tracking in line. We're quite interested in this shift to other mechanisms, which is, frankly, somewhat anticipated but maybe operating a little higher than we thought, and we still believe that a significant majority of Humira will sit at parity lives in 2024. Oh, the tail. Okay. So the tail, you know, we're going to be negotiating 25. And what we've highlighted is we are going to watch exactly how the interchangeables play out. We think we've got a good understanding of that. And so it'll probably become more apparent as we move through 25 where that tail may sit. And we've highlighted that it may start to emerge in 25 and probably be much more visible by 26. And that's going to ultimately depend on how over the course of 25 the price volume fully plays out in the marketplace.
spk10: And Chris, this is Rob. On your question regarding the guidance for this year, I think it's important to note, yes, we've said the vast majority of the erosion is price. We've talked about that dynamic. If you think about first half, second half, we have the annualization impact given the mid-year step-up in rebates last year. So that annualization impact comes through in the first half, so you'd expect price erosion would be greater in the first half or the second half, but at the same time, we did contemplate volume erosion because we were very well aware of the CVS contract. We gave you that guidance, and so we have contemplated that volume erosion, but that's more of a second half versus first half, as well as the potential for, we knew with an interchangeable coming in, there could be some marginal amount of volume pickup there, so we did put in volume erosion in our guidance, but the vast majority of it is price. But I don't want investors to think that we didn't put any volume into our guidance. We were very well aware of the CVS contract, and I think we made some prudent assumptions on potentially other impacts. But overall, we're still tracking in line with that guidance.
spk14: Thanks, Chris. Operator, next question, please.
spk18: Yes, our next question comes from Terrence Flynn with Morgan Stanley. Your line is open.
spk15: Thanks so much for taking the questions, and congrats to Rick, and best of luck to Rob in the new role. Just wondering if you could maybe frame a little bit for us the opportunity for Skyrizzy in UC versus Crohn's disease. I think last time we heard from J&J, Crohn's represented about $7 billion of Stellaris sales. Obviously, you guys have made decent inroads there based on your comments, but just wondering how to think about the dollar opportunity in ulcerative colitis. And then when you were talking through some of the latest Renvoke data, I was just wondering if there's an opportunity down the road as you generate more clinical data but also commercial data to potentially revisit the restrictions online if they're beyond the label at some point or if we shouldn't think about that as a possibility. Thank you.
spk07: Yeah, thanks Terrence. It's Jeff. I'll take the first question. So Crohn's is larger than you see. I mean, if you look at the overall marketer revenue, I think it's 65, 70%. So Crohn's is very, very significant. Having said that, ulcerative colitis is a multi-billion dollar opportunity for us. It's still a very, very under-penetrated and substantial indication. So it's weighted about 65, 35, 70, 30, but still, I wouldn't underestimate what ulcerative colitis means. And I think I would add, in concert with my prepared remarks, we've seen very, very significant acceleration into frontline Crohn's disease with Skyrizzy. And what's remarkable, we studied a very, very difficult population in ulcerative colitis, but we still had a substantial amount of naive patients. And the performance in that naive population is exceptional. I mean, it is at the very, very top of the league table in terms of overall ability to get to endoscopic clearance and symptom control. And so we like that setup because obviously we have exactly the same representatives who are establishing the Crohn's indication in frontline. And we know that we can bring UC very fast afterwards when we get the approval this year. So it's a substantial global opportunity, not the size that we'll see over the LRP with Crohn's, but still one of our largest opportunities that we have in the category. And I'll ask Rupal, based on the safety data he highlighted, to comment on the second question.
spk11: Yeah, thank you. So, you know, the data we keep generating continues to at least drive confidence for sure that the original Phase 3s that came out with their safety profile and what we continue to learn even with longer-term data, even in more high-risk patients, confirms what we've always seen. And that will continue to drive confidence, I think, with our clinicians. From a health authority standpoint, I think that the position there is that you have this oral surveillance study with tofacitinib and they're gonna apply those findings to the other assets in a similar class probably until there's another outcome study to sort of argue against that. That's kinda how we see it. Now that's in the US. I would say globally there's still an opportunity for many jurisdictions where JAK inhibitors can be at parity, so you might start seeing some more movement there in earlier lines. But as Jeff stated in his prepared remarks, the second line and even third line of many of these indications continues to grow as people now have options where in the past, if all you had was a TNF, maybe you were cycling, But now that you know that there's other therapies, you're starting to see people break sooner. So I think that that second and third line is still a huge opportunity and will continue to grow with this emerging data.
spk07: And Terrence, it's Jeff again. One more comment. I mentioned how we're excited about the naive position for both SkyRisi, CD, and UC coming. But what's also nice is those same representatives are in the office and are able to highlight basically a one-two punch where you use Skyrizi first in earlier lines based on this exquisite data, and then obviously for later lines you can use Renvoke. And so we actually see in the marketplace that that combination and that positioning is allowing us right now in real time capturing almost towards 40% of all in-play share with Skyrizi first and Renvoke second. So it's an encouraging position as we fill out that portfolio.
spk14: Thanks, Terrence. Operator, next question, please.
spk18: The next question comes from Carter Gould with Barclays. Your line is open.
spk08: Good morning. Thanks for taking the question. I wanted to circle back on the prior commentary around some of that TRX data. And I guess the overarching question is, is that appropriately kind of capturing all the volume you're really seeing? I mean, there's clearly You know, with your part of your agreement with CVS and the Cordavis there, there is the potential for some Humira volume to potentially be shifting there. Is that being captured by TRX? So I guess any commentary there and sort of, you know, the accuracy of that data that we're all seeing. And then maybe if you just go back and wanted to circle back on the EPS commentary on 25, sort of the way you frame that growth, is that sort of XIPR&D? Any color there would be appreciated. Thank you.
spk07: Yeah, it's a great question. So, you know, it's early, but we believe the data is accurate. I mean, if you look at, you know, the first two weeks, to give you some sense, and this is inclusive of the Cordavis Humira, there was a downdraft of about 13,000 prescriptions for Humira from baseline. And the biosimilars captured about, which was primarily the Cordavis Hiramos, captured about 10. So there's 3,000 prescriptions, or over 20%. that we can see in our data moving to other mechanisms of action, including our Skyrizzy and Renvoke. And again, it's very logical because this is just not a one-to-one type of switch, like these physicians are interviewing and discussing with patients their care path forward, and so we think that clearly some are moving to other mechanisms, and we've seen that in other analogs as well. So we believe the data is accurate. Again, it's early. We're going to continue to monitor it You know, where that ultimately lands, you know, we'll have to see. Again, I want to reiterate the pure Humira downdraft is within line with what we assumed, and we are seeing this other market behavior that's taking place.
spk10: And, Carter, this is Rob. Just to clarify my earlier comments, yes, it is XIPR&D. We always guide to XIPR&D. What I was trying to highlight is you should expect robust revenue growth in 2025 and that growth accelerating in 2026 and beyond, given that Part D benefit redesign impact in 2025. And given that operating margin will expand, you typically would expect our earnings to go faster than our revenue. And that is generally true, with one exception in 2025 being that we will have an annualization impact from that interest expense. We will still deliver It's a very solid earnings growth. But as you model it, just keep in mind that while you expect typically earnings to outpace revenue growth given expanding operating margin, you do have that dynamic in 25 that's important for your modeling.
spk14: Thanks, Carter. Operator, next question, please.
spk18: Our next question comes from Simon Baker with Redburn Atlantic. Your line is open.
spk01: Thank you for taking my questions. Two quick ones, if I may. Just going back to Qmera, but in a slightly broader sense, there's been A degree of political noise around the role of PBMs in blocking or rather than assisting by similar uptake. I just wonder if you expect that to come to anything in terms of structural changes within the market. And then secondly, on RIMVOC and the level up deal, level up data. I wonder how you see the... uh, the competitive, uh, dynamics evolving in that space. Is this about, is this about switches or is this about market expectation, uh, expansion? I asked because this morning Sanofi said that they, they welcome competition as a way of expanding the number of people treated in an area that's still relatively unpenetrated. Um, so I just wonder how you see, uh, the opportunity commercially. Thanks so much.
spk07: Yeah. Thank you for the questions. It's Jeff again. Um, I would say that, uh, we're not anticipating like a wholesale restructure of the PBM industry, for example. I mean, we certainly think that there's a very reasonable chance of sort of transparency reform, you know, exactly how some of the economics are working, maybe transparencies to the government or downstream to the clients. That's very possible. But a major wholesale change, we don't see that happening in the near term. Obviously, we're continuing to monitor that and would make adjustments as we might need to. Regarding your atopic dermatitis question, I think the answer is really a bit of both. I think, as we've highlighted before, the market here is exceptional in terms of the low biopenetration or oral and biopenetration. It's really only about 4% or 5%. So I think Sanofi's comments are very well-timed. I mean, this marketplace is gonna grow significantly as this innovation is able to be delivered to the global population with this very serious disease. But we also think this level-up study is good for our market share penetration, and I'll give you some perspective. You know, our U.S. market share is lower. It's around 9%, so typically where our countries have been able to highlight more direct comparisons. We couldn't do that because of the starting dose I highlighted. We see that most of our international affiliates have market shares in the mid-teens, in some cases in the low 20s. And so the ability to bring a comparative study that's directly linked to the U.S. label and show the physicians how you can get to higher levels of control. And really patients want, they want no disease on their skin and they really don't want itch if they can get there. And that's what we studied in Level Up. So we think it's certainly going to help with both market expansion and, in particular, around the world with our ability to capture some more share. So I hope that helps.
spk14: Thanks, Simon. Operator, next question, please.
spk18: Our next question comes from Tim Anderson with Wolf Research. Your line is open.
spk05: Thank you so much. I have questions on contracting for SkyRisian 25. How many lives do you already have locked up through your general multi-year contracting? And then do you continue to think that the availability of cheap versions of Humira, either brand or biosimilar, won't lead to any increase in step edits on SkyRizzy? Under the idea that while SkyRizzy is better, something like Humira or biosimilar or Stellara might be just fine. That same argument can be made in the statin category. For example, Crestor is the best. Zocor might do just fine. Thanks.
spk07: Yeah, I think we'll probably pass on the number of lives locked up. I mean, we are confident given the market position, Tim, of Skyrizzy and Renvoke. I think in particular around the momentum that we have across the Skyrizzy indications that we're going to have very favorable results access in 2025 and beyond. I think the other thing that we've highlighted is I'm very pleased with how the adoption of Skyrizzy is going in IBD. I mean, it's very, very clear that we're taking significant share from Stelara and the doctors are voting with their pen or their basically electronic prescribing because the ability to get these very sensitive patients under significant control You know, the world's really never seen anything like this sequence trial in terms of the ability to control the most difficult aspect of this challenging disease. So as time goes by, we think that differentiation is going to aid us significantly as we think about the formulary positions relative to not only Humira but also to Stelara.
spk14: Thanks, Tim. Operator, next question, please.
spk18: Yes, the next question comes from Louisa Hector with Beringberg. Your line is open.
spk12: Thank you very much for taking my question. It's on ELA here. I wonder whether you might be able to tell us the full quarter of sales and then any commentary around penetration rate of ELA here and how much off-label use you think may be happening with the guideline inclusion. Thank you.
spk04: Sure. Thanks, Louisa. It's Scott. With respect to the LE here, full quarter of sales, so we closed mid-year in February. Prior to that, there were, according to what we've seen, approximately, let me just double check here, I'm sorry, 110 in the full quarter, 113 in the full quarter.
spk07: And as Jeff, what we also see in the marketplace, a big catalyst that we saw in the first quarter was the movement from the accelerated approval to the full approval that Rupal highlighted with the Marisol data. So we were rapidly able to basically integrate that into all the material of the medical liaisons and certainly the account managers and sales folks and having that definitive table in the label and the ability to go deeper into our call plan is gonna be very positive to continue the growth rates through the rest of the year. In terms of off-label, that's difficult to say. We think that the majority of the sales thus far are in that platinum resistant population. However, the guidelines do allow for reimbursement with different levels of FRA alpha, some of the updates that I mentioned in my prepared remarks. So we'll continue to monitor it, but there's certainly significant headroom in terms of the populations that are coming in terms of the ovarian cancer marketplace.
spk14: Thanks, Louisa. Operator, next question, please.
spk18: Yes, the next question comes from Gary Nachman with Raymond James. Your line is open.
spk20: Thanks. Good morning. Um, we're looking at the strong performance of the neuro franchise of Raylar and migraine in particular, talk about the competitive dynamics there in those markets and how did the gross connects impact you in one queue versus what you expected and how should that trend for the rest of the year? Um, and then with respect to serve, I'll just, you know, your confidence that it will still close by mid year and how FTC is viewing the schizophrenia market. and how much overlap there might be between Imrakladine and Braylar. Just, you know, the latest thinking on that based on your conversations with FTC. Thanks.
spk07: Yeah, hi, it's Jeff. I'll take the competitiveness comment in terms of what we're looking at. We're very pleased with the competitive, our ability to gain market share in these segments. I'll start off with migraine. You know, we continue to be the... the new-to-brand share leader in Botox for chronic migraine, and we see that Q-Lipta is accelerating significantly. So Q-Lipta is now the leading preventative agent. And what's nice is there's very little interaction with Botox because if you're an injector, you use Botox. If you're not an injector, you have access to a fantastic drug with Q-Lipta. So Q-Lipta is really clearly taking over the market leadership positions among the injectable and the oral CGRPs. Ubrelvi continues to have a very meaningful and substantial lead over the main competitor, Nertec, and we are seeing some increased penetration into the larger tryptan segment, which is key to our long-term growth. Braylar continues to perform very well, ongoing market growth, and it's really because we have If we look at our perceptions, Gary, of our key prescribers, you're at the very, very top of the table, the league table, in terms of perceptions around the efficacy around adjunctive major depression, which is our most recent indication, and we have probably the best scope of indications for bipolar one. And so both of those are allowing us to continue to gain share. So we're in a pretty good position. We also feel that the gross to net Our vouchers, our co-pay, which sometimes can get a little funky in the first quarter, we have strong controls there, and we're seeing a lot of stability. So overall, those businesses are performing very well.
spk10: Gary, I'll take your question. This is Rob. I'll take your question on the FDC. We are working closely with the agency on their additional requests. I mean, keep in mind that we do not have any overlapping MOAs with Cerevol. And Raylar's share in schizophrenia is very low. The vast majority of Raylar sales comes from the bipolar and AMDD indications. In the case of Devapodon, it will serve the early Parkinson's segment, which Duodopa and BioLab do not participate in. So we don't have any concerns with the merits of the transaction and continue to expect closing it in the middle of the year.
spk14: Thanks, Gary. Operator, next question, please.
spk18: Yes, the next question comes from Steve Scala with TD Collin. Your line is open.
spk09: Thank you very much. And I apologize in advance for asking you to clarify on Humira. But you mentioned several times that things are playing out as planned. But in the prepared remarks, you said U.S. erosion played out slightly better than you thought in Q1. So is the conclusion that whatever was better is temporary? You also mentioned volume pressure, but price offset by price benefit. Can you quantify that? But when you sum it all up, it sounds like you expect volumes to underperform the expectations you set three months ago? And is that in part maybe due to the credo news from yesterday? So that's a long question, but that's only one question. The second question is, curious if the FDA has contacted AbbVie about the potential safety issues with amlacridine post the competitor issue with convulsions and rabbits. And have you seen this with your agent? Thank you.
spk07: Yeah, so it's Jeff, so I'll try to take that. So the first part was the first quarter. I mean, it was marginally better in terms of overall performance because we didn't see, obviously, we didn't see any volume disruption until 4-1. Now, when you look at 4-1 and we look, you know, After three weeks, we look at our model in terms of the expectation around retention of Humira with the CVS template. That's largely tracking in line with what our expectations were, with a bit of the surprise that some of that Humira is not going to the biosimilar, as I mentioned, it's going to other mechanisms, including Skyrizzy and Renvoke. So overall, as we As we look to the balance of really the first quarter, what we're seeing play out in the second quarter, and look to the full year, our commentary, and I'll ask Rob to highlight if he has anything to add, is very much in line with what we've guided at the beginning of the year. So no material change in what we're seeing in the marketplace.
spk10: Yeah, this is Rob. I'll confirm that, what Jeff is saying. I mean, it's tracking in line with our expectations. We are not saying... That volume is worse than we originally guided. We're saying this is tracking in line with our expectations. We try to characterize for you the price versus volume dynamics. Obviously, saying it's, you know, the price erosion is the vast majority of the decline, but there is volume, and it's tracking exactly as we anticipated. So there isn't an additional downside here. And as Jeff mentioned, we did have slightly better performance in the first quarter, but, again, it was, I mean, I think to the tune of $30 million to $40 million on this book of businesses. not overly material, but ahead of the initial expectation.
spk11: Hey, Steve, it's Rupal. I can take the next question. We did a thorough diligence, and when we look at data sets that offer clinical data, obviously we do a deep dive there, also look at blinded data, but we also do a deep dive looking at toxicology, animal tox, in particular, and we didn't observe anything that was consistent with what has been described thus far. And as I mentioned, when we look at blinded safety data, either from the 1B or the current pivotals that are running, we don't see an adverse event like this that would be related. And as far as we know, no health authority has reached out to ask any further questions about this.
spk10: Steve, this is Rob. I'm going to come back to your previous question and maybe I understand where the confusion could be. That one-time price benefit is a year-over-year dynamic. It was contemplated in our guidance. When you have a formulary change, you essentially have those rebates go away and you recognize that. That was part of our guidance. That was not a benefit versus our guidance. That's a benefit in the year-over-year. So you look at Scott guided to, I think it was 32% erosion in the second quarter, which is lower than, it was around 40% in the first quarter. So naturally you'd wonder why would you have less erosion? Well, there's that year-over-year dynamic, but that was how we planned the year. We anticipated this because we knew about the change that was coming in April 1st. So I don't want you to interpret that as a benefit versus our guidance. That's a benefit in the year-over-year calculation.
spk14: Thanks, Steve. Operator, next question, please.
spk18: Yes, our next question comes from Truong Huong with UBS. Your line is open.
spk19: Hi, guys. Truong Huong from UBS. Congratulations, Rick, on the next chapter of your life and Rob for moving AbbVie forward. Again, on by a similar Humira, in your remarks, you mentioned post the expected CVS contract, there was a step up in price for Humira. Is that simply because you were giving away more price to CVS at the contract at the time? And you mentioned additional contracts moving to buy similar like CVS this year. Are there any meaningful contracts here that you can flag so we're not surprised? And is it possible we could see actually a pricing increase by year end because of this? Thanks very much.
spk04: This is Scott. I'll start with your question regarding the price benefits. So in my remarks, I indicated that with the formulary change in CVS and the volume step down we saw there, that there's a one-time price benefit associated with that. And you can think of this as, you know, as we have the volume declines, that volume had been associated with price that we would have been paying in terms of rebate. Those rebates will no longer be paid. Therefore, there's a one-time price benefit associated with that initial step down in the quarter. So that's what that relates to.
spk07: Yeah, and in terms of what we see going forward, as I highlighted, we don't see a significant exclusionary action where Humira would be removed from a formulary going forward. We did plan for, obviously, that smaller plans may make some adjustments to their formularies. That's all within the volume degradation and the pricing dynamics that we put into our guidance. And as I mentioned in one of the comments, some of the payers, not super large, would maybe consider this idea of starting new patients on the biosimilars versus maintaining all the existing patients on Humira. So if you were to see that, you shouldn't be surprised about that, and that would be within the contemplative approaches that we're taking as we look across 24 with our knowledge of what's happening in the marketplace.
spk14: Thanks, Chong. Operator, we have time for one final question.
spk18: Okay, and our final question comes from Evan Siegerman with BMO Capital Markets. Your line is open.
spk06: Hi, guys. Thank you so much for taking my question. On the aesthetics business, maybe talk to me about some of the dynamics you're seeing in China. I know that there's a lot of macro headwinds, and this is a pretty big part of your business. And then a bit of housekeeping on SkyRizzy. Last quarter, you disclosed the $1.9 billion cash payment for royalties. Can you provide us any color on what this quarter's royalty was? And I believe that was for the full year last year, but maybe just for this Thank you.
spk13: Hi, this is Carrie. I'll address your question on aesthetics in China. And we do expect economic headwinds that we're seeing in China to persist over the near term with the China aesthetics market flat overall for 2024. So the way to think about it is to expect negative markets until the recovery starts to begin in the second half of 2024. China does remain a very important market for our aesthetics business and as the market there starts to recover, we will continue to invest in consumer activation, injector training, and continue to launch new products in this important market.
spk04: Hi, it's Scott. So you're right. With respect to the schedule relative payments, so you have to remember that these are on a bit of a lag so they don't track each quarter sales, but the $400 million was the amount in the first quarter that we paid in cash payment.
spk14: Well, thanks, Evan. That concludes today's conference call. If you'd like to listen to a replay of the call, please visit our website at investors.abby.com. Thanks again for joining us.
spk18: Thank you. That concludes today's conference. You may all disconnect at this time.
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