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spk17: Good morning and thank you for standing by. Welcome to the AbbVie second quarter 2024 earnings conference call. All participants will be in a listen-only mode 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.
spk16: Good morning and thanks for joining us. Also on the call with me today are Rob Michael, Chief Executive Officer, Jeff Stewart, Executive Vice President, Chief Commercial Officer, Rupal Thakkar, Executive Vice President, Research and Development, Chief Scientific Officer, Scott Renz, Executive Vice President, Chief Financial Officer, and Kerry Strom, Senior Vice President, AbbVie, and President, Global Allergan Aesthetics. Before we get started, I'll note that some statements we make today may be considered forward-looking statements based on our current expectations. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause 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 Rob.
spk07: Thank you, Liz. Good morning, everyone, and thank you for joining us. It's a pleasure to speak with you today as Abby's new CEO. I look forward to building on our track record of success and delivering on Abby's promise to our patients, employees, shareholders, and communities. As we begin this new chapter, nearly every aspect of Abby's business is performing at, or above our expectations. We are demonstrating a rapid return to revenue growth, with operational sales up nearly 4% through the first half of this year, including robust mid-single-digit growth in the second quarter. Our exumeric growth platform, which covers more than 80% of AbbVie's total sales, will outperform our initial full-year sales guidance by more than $1 billion. driven by strong performance in immunology and oncology. In addition, US Humira performance continues to meet our expectations, having achieved or exceeded our guidance in all six quarters with biosimilar competition. The strong performance across our diversified portfolio will drive top-tier, high single-digit compound growth through the end of this decade. which will support continued investment to drive growth in the next decade. Turning to our results, I'm especially pleased with Immunology, where our leading portfolio is delivering performance well above our expectations. Guy Rizzi continues to demonstrate strong momentum in psoriasis and Crohn's disease, where we have substantial headroom for additional share gains. and the recent approval in UC will add another source of long-term growth. Renvoke is also delivering robust growth across all approved indications. We are making excellent progress with late-stage development in five additional indications that we anticipate will launch in the second half of this decade. In oncology, Elihir has accelerated our on-market presence in solid tumors. We also have several exciting pipeline programs, including two novel CMET ADCs for solid tumors, Teliso-V and 400, as well as 383, our BCMA-CD3 bispecific for multiple myeloma. In neuroscience, our leading therapies for migraine and mood disorders continue to gain share and are competitively well-positioned. The pending acquisition of Cereval will further augment our neuroscience pipeline, and we're excited about what our two companies can achieve together to make a difference for patients with neuropsych disorders. We have certified substantial compliance to the FTC second request and anticipate the Cereval transaction will close soon. Lastly, we've been very active with business development. investing in exciting opportunities that can drive growth in the next decade. Through the first half of this year, we have executed nearly a dozen early stage deals. These include promising technologies and innovative mechanisms that can elevate the standard of care in immunology, oncology, and neuroscience. In summary, I'm very pleased with the strong momentum of our business. AbbVie's results once again exceed our expectations, and we are raising guidance for the second time this year, underscoring our confidence in the business. The robust performance of our growth platform and the advancement of our pipeline supports AbbVie's top-tier long-term outlook. With that, I'll turn the call over to Jeff for additional comments on our commercial highlights. Jeff?
spk04: Thank you, Rob. We continue to demonstrate strong commercial execution across our therapeutic portfolio. I'll start with the quarterly results for Immunology, which delivered total revenues of approximately $7 billion. Guy Rizzi and Rynvoke are performing exceptionally well, contributing more than $4.1 billion in combined sales this quarter, reflecting operational growth of 50% in their fifth full year on the market. These assets are approved across a broad set of indications and are collectively supported by nine compelling head-to-head studies that demonstrate clear differentiation across multiple novel therapies, which has resulted in strong share capture. For Skyrizzy, we continue to advance our clear leadership position in psoriasis, where total prescription share of the U.S. biologic market has increased to approximately 38%. Share is also ramping nicely in PSA, especially in the dermatology segment, where Skyrizzy has achieved roughly 15% total prescription share in the U.S. biologic market. And for RINVOC, we are seeing increasing share across each of the room indications, as well as additional momentum in atopic dermatitis, including total prescription share of 10% in the U.S. We are very excited about the growth potential in gastroenterology, where Skyrizzy and Rynvoke are on pace to double their respective sales in IBD this year. The adoption in Crohn's disease has been impressive, with Skyrizzy and Rynvoke now achieving a combined in-play share in the U.S. of more than 40%. Skyrizzy has achieved overall in-play share leadership in Crohn's, with in-play share approximately now 13 points ahead of Stelara, following our compelling head-to-head sequence data published last year. This positive trial, which demonstrated Skyrizzy's high efficacy versus Stelara, including a more than doubling of effect in endoscopic remission, has driven a significant inflection in performance, and we anticipate continued share momentum. Commercialization for Skyrizzy and ulcerative colitis is now underway in the US, with broad formulary access anticipated to ramp quickly over the next several months. Early feedback from gastroenterologists has been very encouraging, with Skyrizzy's UC data viewed as impressive, particularly for naive patients who have not been exposed to biologics. We also expect the European launch in the coming months. We also see very robust adoption of Renvoke in UC, where the brand is now achieving a leading in-place share in the U.S. Internationally, Renvoke UC is now approved in 75 countries with reimbursement and share gaining momentum. Having two novel therapies that each deliver differentiated levels of efficacy to treat both of these IBD conditions, demonstrates our commitment to transforming the treatment landscape for physicians and patients in this area of high unmet need. Turning now to Humira, which delivered global sales of $2.8 billion, down 28.9% on an operational basis due to biosimilar competition. Erosion in the U.S. was in line with our expectations in the quarter. and our guidance contemplates the impact of additional formulary changes over the course of the year. Importantly, 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 $1.6 billion. In Bruvica, global revenues were $833 million, down 8.2%. reflecting continued competitive dynamics in CLL. Benclecta global sales were $637 million, up 15.8% on an operational basis, with strong momentum across CLL and AML. Ella here is also performing very well, with sales of $128 million, and our compelling overall survival data Recent positive updates in the NCCN guidelines and the expansion of commercial resources will continue to drive rapid uptake. Lastly, we continue to be pleased with the prescription trends for Epkinley in DL-BCL. Commercialization is now underway for Epkinley's second indication, follicular lymphoma, in the U.S., with European approval expected later this year. Neuroscience total revenues were nearly $2.2 billion, up 15.2% on an operational basis. This robust performance is driven by continued double-digit growth of Braylar with global sales of $774 million, Ubrelvi with total revenue of $231 million, and QLipta with global sales of $150 million. Each of these leading assets continue to gain share and remain competitively well positioned. Botox Therapeutic is also performing well, especially in chronic migraine. Total global sales were $814 million, up 9.6% on an operational basis. Finally, we are pleased with the early launch trends for 951 in Japan and Europe, and look forward to bringing this innovative therapy for advanced Parkinson's to the U.S. soon. Overall, I'm extremely pleased with the momentum across the therapeutic portfolio. And with that, I'll turn the call over to Carrie for additional comments on aesthetics. Carrie?
spk15: Thank you, Jeff. Second quarter global aesthetic sales were approximately $1.4 billion, representing growth of 2.8% on an operational basis. In the U.S., aesthetic sales of $863 million increased by 4.4%, driven by Botox cosmetic and Juvederm growth of 7.1% and 10.4%, respectively. This toxin and filler performance is supported by a consistent recovery in the facial injectable market, as the number of procedures in both categories increased by a mid-single-digit percentage versus the prior year. However, this level of market growth was lower than previously anticipated. Sales for Botox Cosmetic and Juvederm also benefited from a partial reversal of the prior quarter's inventory destock, which was related to the timing of certain promotional activities. From a competitive perspective, our U.S. facial injectable portfolio remains the clear market leader with strong and stable market share. Internationally, second quarter aesthetic sales were $527 million, roughly flat versus the prior year on an operational basis, as declines in China were balanced by growth in other international markets. In China, our largest international market, sales growth continued to be impacted by sustained economic headwinds, as well as a challenging comparison to the second quarter of last year, which benefited from a strong post-COVID recovery. Consistent with what we experienced in the U.S., economic challenges have impacted Juvederm sales growth more than other areas of our portfolio based upon Juvederm's relatively higher price point. Looking to the rest of the year, we expect our market-leading aesthetics portfolio to continue to perform well from a competitive perspective across the globe. As we evaluate market dynamics and leading economic indicators, particularly in the U.S. and China, market growth trends are below our prior expectations. Based upon this, we have moderated our outlook for the remainder of the year. Despite this near-term dynamic, we remain confident in the long-term growth outlook of our aesthetics portfolio. Global market penetration rates are extremely low, and we expect long-term market growth to accelerate from current levels as economic conditions improve. As the market leader, we are also committed to driving growth by activating new patients and launching innovative treatment options. For example, in China, launch activities are underway for the Botox Cosmetic Masseter Muscle prominence indication. And in the U.S., we will soon launch Juvederm Voluma XC for the treatment of temple hollowing, and we expect an approval for Botox Cosmetic in the Platysma prominence indication by the end of the year. Pipeline catalysts like these in the key U.S. and China markets, along with our significant investment in consumer activation, injector training, and practice support, will enable us to grow the aesthetics market and maintain our clear leadership position over the long term. With that, I'll turn the call over to Rupal.
spk07: Thank you, Carrie. We continue to make very good progress advancing our pipeline with several regulatory and clinical milestones since our last earnings call. I will start with immunology. We received FDA approval for Skyrizzy and ulcerative colitis. which marks its second inflammatory bowel disease indication. Gyrizzi is now the only IL-23 specific inhibitor approved for both ulcerative colitis and Crohn's disease. Gyrizzi has proven to be a highly effective, durable, safe, and well-tolerated treatment option for patients with moderate to severe inflammatory bowel disease. And this recent approval further strengthens AbbVie's leadership position in this market. We also received a positive CHMP opinion recommending Skyrizzy for the treatment of moderate to severe ulcerative colitis in Europe, with an approval decision anticipated soon. Earlier this month, we submitted our regulatory applications in the U.S. and Europe for RENVOC and giant cell arteritis. Our submissions are based on the previously announced Phase III results from our select GCA trial. where RINVOC demonstrated superiority compared to placebo on sustained remission from week 12 through week 52 on disease flare and showed a reduction in total steroid exposure at week 52. We expect approval decisions for this indication next year. We also recently began a Phase III study for ludicizumab, our anti-IL-1 alpha-beta bispecific in Hydradenitis supertiva. HS is a skin disease that can be debilitating, and there are limited treatment options. In our Phase II study, ludicizumab demonstrated strong clinical response rates and improvement in skin pain in a very refractory patient population. Based on these results, we believe ludicizumab has the potential to become an important new treatment option for patients with moderate to severe HS. We look forward to providing updates on the phase three program as the data become available. In the second quarter, we announced two additional immunology transactions as we continue to invest in external innovation to expand our pipeline. These include the acquisition of Celsius Therapeutics, which brings a phase two ready anti-TREM1 antibody for IBD, and a license agreement with FutureGen, to develop a next generation anti-TL1A antibody for IBD that is designed to have less frequent dosing compared to other TL1As in development and will be evaluated in combination with Skyrizzy. This follows the four immunology deals we announced earlier this year, which as a reminder included the acquisition of LANDOS and their oral NLRX1 agonist in Phase II for UC, a partnership with OSI to develop a novel ChemR23 agonist for IBD and RA, a collaboration with Parvus to utilize their immune tolerization platform for novel IBD therapies, and a collaboration with Pentarex to develop conditionally active multispecific biologics in immunology and oncology. Moving to oncology, where we continue to make very good progress across all stages of our heme and solid tumor pipeline. In the area of solid tumors, we recently announced positive top-line results from our Phase II FICOLO study, evaluating Elihir as a monotherapy in ER alpha-positive, third-line-plus, platinum-sensitive ovarian cancer. for those not eligible for re-treatment with platinum-based therapies. Elihir met the primary and key secondary endpoints in the study, demonstrating an objective response rate of 52% and median duration of response of eight and a quarter months. Detailed results will be presented at an upcoming medical congress. Following discussions with the FDA, we will be submitting to LISO-V for accelerated approval as a monotherapy in patients with previously treated CMET overexpressing EGFR wild-type non-squamous non-small cell lung cancer. This submission will be reviewed under FDA's real-time oncology review program. Deliso-V has also received breakthrough therapy designation from the FDA. Our submission will be based on the results of our Phase II luminosity study. where Teliso-V demonstrated strong clinical benefits across key endpoints, including overall response rate, duration of response, and overall survival, with a tolerable safety profile. Submission is expected in the third quarter, with an approval decision anticipated in 2025. The confirmatory phase three study for this potential accelerated approval is currently ongoing. We continue to see encouraging data for ABBV400, our next generation CMET ADC, which uses a topo payload. Recall that we've advanced 400 in late-line colorectal cancer based on the deep responses and prolonged durability observed as a monotherapy in our phase one trial. And we remain on track. to begin a phase three study later this year in third line CRC. We're also seeing encouraging signals of activity for this next gen ADC in the non-small cell lung cancer cohort from our phase one study. The preliminary data will be presented at an upcoming medical meeting and based on the emerging phase one results, we plan to begin a phase two program for 400 in lung cancer. In the area of hematologic oncology, we received accelerated approval in the U.S. for Epkinley as a monotherapy treatment for patients with relapsed refractory follicular lymphoma after two or more lines of prior therapy. Epkinley is now the only T-cell engaging bispecific approved in the U.S. to treat both follicular lymphoma and diffuse large B-cell lymphoma. We're extremely excited to bring this new subcutaneous treatment option to patients suffering from follicular lymphoma. We also recently received positive CHMP opinion with an approval decision in Europe expected later this year. In the quarter, we initiated a Phase III monotherapy study for ABBV383 in third-line multiple myeloma. 383 is designed for high affinity binding to BCMA on malignant cells and low affinity binding to a unique CD3 epitope on T cells, which has the potential to mitigate some of the adverse events associated with other T cell-engaging BCMA-based therapies while preserving high levels of efficacy. We remain excited about this asset's potential to become a best-in-class BCMA BD3 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. In addition to our Phase III monotherapy program, We have an ongoing Phase I study in later lines of multiple myeloma to evaluate 383 in various combinations, including with Pomalyst, Revlimid, and Darzalex. Based on this work, we will begin Phase II combination studies in earlier lines of therapy next year. Moving to neuroscience, we're in the quarter we announced that we received a complete response letter for our 951 regulatory application in the U.S., The CRL is based on observations identified during an inspection at a third-party manufacturing site that was unrelated to 951. The CRL did not identify any issues related to the safety, efficacy or labeling of 951, nor has the FDA requested any additional clinical data or device-related testing. We're working closely with the site and the FDA to get clarity on timelines and we'll provide updates as soon as information becomes available. Moving to an update on one of our Alzheimer's disease programs. We recently completed an interim analysis of a phase two study evaluating ABBV916, our A-beta antibody. The emerging efficacy and safety profile in this study is similar to what has been demonstrated by approved agents. However, given the evolving landscape, we do not believe 916 as a monotherapy treatment will be sufficiently differentiated from other emerging therapies. As a result, we are discontinuing further development for 916 as a standalone antibody. As Rob mentioned, we remain on track to close the Cerevel transaction soon, and we look forward to welcoming the team into our R&D organization. The Amracladine Pivotal Studies in Schizophrenia remain on track to begin reading out near the end of this year. We'll also see data from two additional Phase III studies for Tevapidon in Parkinson's disease later this year. We look forward to providing updates on these programs once the transaction has closed and data are available. In aesthetics, we recently received approval for Botox in China for masseter muscle prominence, marking the first global approval in this indication for any neurotoxin. Masseter prominence is common in Asian populations, and there is significant unmet need for minimally invasive treatment options. We anticipate high demand for Botox in this novel indication in China, which will help to further build our portfolio in the face shaping segment. A regulatory application is under review in the U.S. for Botox and platysma prominence, which is another novel indication that will help build our position in the lower face and neck segment. We continue to expect an FDA approval decision later this year. and we remain on track to submit a regulatory application for Bonte near the end of this year. A rapid onset, short-acting toxin has a highly differentiated clinical profile, and once approved, would offer patients a novel option compared to currently available toxins. So in summary, we've made great progress across all of our therapeutic areas in the first half of the year, and we look forward to additional data readouts regulatory submissions, and approvals throughout the remainder of 2024. With that, I'll turn the call over to Scott.
spk03: Thank you, Rupal. Starting with our second quarter results, we reported adjusted earnings per share of $2.65, which is 10 cents above our guidance midpoint. These results include a 52 cent unfavorable impact from acquired IPR&D expense. Total net revenues were nearly $14.5 billion, $450 million ahead of our guidance, and reflecting robust growth of 5.6% on an operational basis, excluding a 1.3% unfavorable impact from foreign exchange. Importantly, these results reflect more than 18% sales growth from our Exumera growth platform. Adjusted gross margin was 85.2% of sales, Adjusted R&D expense was 13.3% of sales, and adjusted SG&A expense was 22.9% of sales. The adjusted operating margin ratio was 42.6% of sales, which includes a 6.5% unfavorable impact from acquired IP R&D expense. Net interest expense was $506 million. The adjusted tax rate was 18.8%. Turning to our financial outlook, we are raising our full year adjusted earnings per share guidance by 10 cents to between $10.71 and $10.91. This EPS guidance continues to contemplate approximately 19 cents of dilution for the pending acquisition of Cerevel, which is expected to close soon. Please also note that this guidance does not include an estimate for acquired IPR&D expense that may be incurred beyond the second quarter. We now expect total net revenues of approximately $55.5 billion, an increase of $500 million. At current rates, we expect foreign exchange to have a 1% unfavorable impact on full-year sales growth. This revenue forecast includes the following updated assumptions with the entire sales increase, once again, driven by our Exhumera growth platform, which is now on pace to deliver nearly $6 billion of sales growth in 2024. We now expect SkyRisi global sales of approximately $11 billion, an increase of $300 million due to strong performance across all approved indications. Renvoke total revenue of approximately $5.7 billion, an increase of $100 million reflecting continued robust uptake in IBD. Then Clexa total sales of approximately $2.5 billion, an increase of $100 million, reflecting momentum in both U.S. and international markets. And for aesthetics, we now expect global revenue of approximately $5.5 billion, given slower than expected near-term market growth, particularly in the U.S. and China, As a result, our total sales guidance for Botox and Juvederm will each be lower by roughly $100 million. Moving to the P&L for 2024, we continue to forecast a full-year adjusted gross margin of approximately 84% of sales, adjusted R&D investment of 14%, and adjusted SG&A expense of 23.5%. we now anticipate an adjusted operating margin ratio of roughly 44.5% of sales, in line with our previous expectations after including the approximately 2% impact of acquired IPR&D expense incurred through the second quarter. And we forecast our non-GAAP tax rate to be approximately 16.3%, also reflecting the impact of IPR&D. Turning to the third quarter, we anticipate net revenues of approximately $14.2 billion. At current rates, we expect foreign exchange to have a 1.3% unfavorable impact on sales growth. We expect adjusted earnings per share between $2.92 and $2.96. This guidance does not include acquired IPR&D expense that may be occurred in the quarter. In closing, AbbVie has once again delivered outstanding performance, and I'm very pleased with the strong momentum across the portfolio heading into the second half of the year. With that, I'll turn the call back over to Liz.
spk16: Thanks, Scott. We'll 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.
spk17: Our first question comes from the line of Terrence Flynn from Morgan Stanley. Please go ahead.
spk00: Great. Thanks for taking the question, and congrats, Rob, on the CEO position. Looking forward to the forward here. A question I had is, you know, last quarter you guys gave some early commentary on how to think about 2025. You know, looking at the business, obviously momentum in immunology, some headwinds in aesthetics. So any update on how you're thinking about the 2025 outlook, particularly, you know, growth for revenue relative to EPS? Thanks.
spk03: Thanks, Terrence. This is Scott. I'll handle the question. So with respect to 25, you know, as you know, we haven't given guidance yet, and we'll provide that at a later time. But we have communicated a few top-level, high-level items to put in context the several dynamics at play next year. We have indicated that we'll be returning to robust revenue growth, despite the headwinds from Medicare Part D redesign and continued Humira erosion. And when you think about robust growth, we characterize robust growth to be above industry average growth, which we see in the low single digits. So when you think about the drivers, you know, I mentioned in my remarks that we have $6 billion of growth from the growth platform in 2024 that we're expecting. $5 billion of that is coming from Sky Rizzi and Renvo Cologne. Our Neuros franchise is growing by more than $1 billion, and aesthetics has begun to recover from the economic headwinds. In 2025, we see incremental contributions from SkyRizzy UC, which was recently approved, as well as 951. All of these factors demonstrate strong momentum in the business. And then when you think about the offset of Humira, you know, that erosion that we have expected this year at $4.5 billion, last year that erosion was $6.5 billion, and we do expect another step down in absolute dollar terms in 2025 for that erosion as well. So that will be less of a headwind to growth in 2025 than it was in 2024. So we feel very, very strong about that. And I think from a Part D perspective, we've talked about the several points of growth headwinds that we see there. And I think when you model that, you can think about those several points as approximately a 3% headwind to growth. So overall, very strong momentum from the business with some headwinds, but we feel very confident in our ability to return to robust growth at the top line. Regarding EPS, the bottom line, we see EPS growing in line with that revenue growth that we've talked about. So EPS will benefit from operating margin expansion. We've talked about that operating margin expansion will be on the SG&A line as we leverage the revenue growth and drive efficiencies, and we have a good history of doing that. So that operating margin will expand. However, that expansion will be roughly offset by the fact that in 2025 we'll have a full year of interest expense associated with the financing for Ceravel and Immunogen. So robust growth at the top line and in-line growth from an EPS perspective.
spk16: Thanks Terrence. Operator, next question please.
spk17: Next we'll go to the line of Chris Schott from JPMorgan. Please go ahead.
spk02: Great. Thanks so much. Just two questions for me. Maybe first on Rynbook and Skyrizzy, great results in the quarter. Can you elaborate a little bit more on the price versus volume dynamics this quarter? It seemed like results were maybe a little bit stronger than the RX trends would have implied, and I just was wondering if there was anything notable there. My second question was on the immunology portfolio, and as we think about 2025, I know we're probably in the middle of contracting season right now, but just directionally, what are you anticipating for Humira? And should we be thinking about any incremental pressures on RINVOC and Skyrizzy just given biosimilar hemorrhoid dynamics going forward? Thanks.
spk04: Yeah. Hi, Chris. It's Jeff. I'll take that question. So, as noted, we're very, very pleased with the fundamental momentum on RINVOC and Skyrizzy. So, all of the indications are really hitting their stride. So we can see the impact of obviously consumer investments we've made. We've adjusted some of the sales forces. We started to anticipate the ulcerative colitis that's helped us basically increase our share of voice. And I think the other dynamic in terms of some of the incremental strength has come from this dynamic that we started to see earlier in the quarter where some of the humerus switching that takes place actually starts to accrue towards Skyrizzy and Renvoke because the physicians, when there's this disruption in the market, will sometimes bring in those patients and start to assess them. And we saw about 20% would move to other mechanisms. So while it's a component, there are certainly multifactorial approaches why we see this very, very strong volume dynamic and share capture for patients. for both of those agents. If I move to the contracting for 2025, obviously the contract season is in progress and it's progressing. And the negotiations are well underway. I think it's important if you'll recall that we already have some multi-year contracts in place that cover 2025. So that's a positive dynamic. The remaining payer negotiations, as I mentioned, are underway and we anticipate that those will close out during the normal cycle. I would say that, you know, at a macro level, we do expect to maintain parity access next year for Humira for a meaningful portion of lives across all of the channels. Now, that said, our Humira access will certainly be lower than this year. as we continue to anticipate and watch certain segments of the market move to adopt biosimilars. And we've understood and planned for this, obviously, as we enter that third year of the biosimilars. And so we're well aware of dynamically evaluating how this is going to work out. So certainly things are progressing. We already have some in place from those multi-year contracts. And we'll be in a better position to provide some more information, obviously, later in the year as those negotiations or the remaining negotiations fully close out.
spk07: And, Chris, this is Rob. Just to reiterate an important point that Jeff made, I mean, one trend that we are watching very closely is the switching from the humeral molecule to new mechanisms. I mean, we are starting to see an inflection that is accruing to new mechanisms like Skyrizi and RIMBOK, as Jeff mentioned. And it makes sense. Doctors that are reevaluating the patients in their practice are likely looking at more than just the patients that are covered by CVS. What we have factored in is the CVS impact. What we didn't factor in necessarily is a impact beyond just the CVS lies. And to the extent that trend continues, it would represent a downside for Humira and an upside for scirrhizia and RINVOC, which is a very good long-term tradeoff for us. That's an important point. We want to make sure that was captured.
spk04: Thank you, Rob. And maybe, Chris, one more point that I didn't address was the Skyrizzy and Renvoke contracting. So we are anticipating very robust and consistent access for Skyrizzy and Renvoke. And our former comments around sort of low single-digit price erosion should be quite consistent with what we said before. Obviously, the Medicare Part D is a separate dynamic, so things are stable and we're anticipating ongoing very strong access for both of those brands.
spk16: Thanks, Chris. Operator, next question please.
spk17: Next, we'll go to the line of Carter Gould from Barclays. Please go ahead.
spk06: Good morning. Thanks for taking the question, and then congrats on the results. I guess first, just a housekeeping point. I guess in the last call, you had talked about earnings growth not being quite at the rate of revenue growth, and it sounds like today you see those more in line. Any, I guess, further color on kind of what's driving that? I would assume it's sort of the key I&I drivers, but any other color there would be appreciated. And I guess the more pertinent question, maybe on the commentary on Cerevel, Should there be any expectation for divestments or other concessions as we contemplate that deal closing? Thank you.
spk03: Yeah, this is Scott. I'll take the question regarding EPS growth or earnings growth in line with the revenue growth. So, when we look at this, as I mentioned, we're looking at a couple of things. that were driving some operating margin expansion. You know, we spent a lot of time focusing on that, and we do see some efficiencies that we can drive, and we do see we'll have the ability to leverage that. So there will be expansion operating margin, which you would expect to then let earnings outpace the revenue growth. However, there is this offset, and we had a very successful bond offering when we set the financing in place for Cerevel and Immunogen. But that will be an offset to the operating margin expansion. So you can think of those two as essentially netting one another and then driving that earnings growth in line with the top line.
spk07: And Cara, this is Rob. I'll take your question on Cereval. Look, we've made very good progress with the FTC and have certified substantial compliance to their second request. No divestments are expected. I would expect the transaction to close soon, potentially as early as next week. We're obviously very excited about the potential best-in-class therapies in Cereval's pipeline, especially in raclidine for schizophrenia. devapidon for early Parkinson's, and their core antagonist for major depression. I mean, these assets clearly will be great additions to our neuroscience franchise.
spk16: Thanks, Carter. Operator, next question, please.
spk17: Next, we'll go to the line of Amudh Devan. Please go ahead.
spk01: Yeah, hi. Thanks for taking my question. So maybe one if I could just, I guess for Rob, just around sort of your business development priorities now. You obviously did a sort of larger deal last year with Cervell, Imogen. You've done a number of these smaller acquisitions. And I guess I'm trying to get a sense of the kind of balance between investing for the long term and then sort of balancing the near-term earnings growth outlook. So there's a lot of focus on that $11 floor. For a long time, obviously, with all the IPR&D, you sort of dipped a little below that for this year, which makes sense. But I'm just trying to think now that we're sort of halfway through the year, how are you thinking about sort of where your priorities are and, you know, the need to kind of balance the near-term numbers versus investing for the long-term. Thanks.
spk07: Yeah, Vamo, thanks for the question. So, you know, the $11 floor, again, was on an ex-IPRD basis, where obviously with this guidance, ex-IPRD, I think we're just a little bit over $11.40. and we're certainly positioned to return to robust growth. I mean, we're delivering robust revenue growth this quarter. When you look at the outlook for 25, it's very strong, and so we should be beyond the conversations on the floor at this point. As we think about the tradeoffs for the long term and the short term, clearly we have an on-market portfolio today that can drive the growth that we need to deliver on that high single-digit, top-tier outlook in this decade. So our BD efforts continue to be focused on early-stage assets that can drive growth in the next decade. And you've seen us execute nearly a dozen deals this year along those lines. These include new mechanisms in immunology that can combine with Skyrizio or RENVOC or be pursued as monotherapies. We've also added new platforms, including multi-specifics that have applicability in immunology and oncology. Our deal targeting in situ CAR-T therapy is another example of a platform investment that and oncology and we added a novel mechanism for psychiatric disorders given our focus in neuroscience. So we intend to continue adding more depth to our pipeline in our core areas, particularly think about it, you know, early stage deals because what we're really trying to set up for is that growth in the next decade. We have a clear line of sight to top tier growth this decade and we want to position the company to deliver strong growth in the next decade as well.
spk16: Thanks, Vamil. Operator, next question please.
spk17: Next, we'll go to the line of Chris Chibutani from Goldman Sachs. Please go ahead.
spk13: Thank you. Good morning. On the aesthetics business, today has been a day of reporting across the industry. There's some commentary that aligns with what you said. However, some additional questions I have are on granularity about procedure volumes and pricing. Now, in the first quarter, you talked about promotional activities that you pushed towards a seasonally strong second quarter. One, should we think about the pricing backdrop as being a component of some of the sluggishness as opposed to purely thinking about or primarily thinking about volume of procedures? And if you could sort of respond in the neurotoxin neuromodulator versus the filler segment, that'd be helpful. Thank you.
spk15: Hi, this is Carrie. I'll address the question. First, let's talk about the market dynamics for market growth in the U.S. for facial injectables. So, late last year, we started to see a recovery and a return to growth of the toxin market, and we've seen that market growth recovery continue this year in that mid-single-digit range. And that's volume, that is traffic into our customers' offices that's really been consistent for the past few quarters. So the market dynamics for our business are really driven by patient demand and volume, although when we think about price, price is a factor that we'll be looking for the second half of the year, which will give us some favorable pricing dynamics. We did take a price action at the beginning of the year for toxins, and then we will have some more efficiency when it comes to our strategic shifts in our pricing promotions for the second half of the year. So one example of that would be promotions we did last year, for example, around competitive launches that we won't need to do this year based on the success of our competitive strategy last year. So really our performance is driven by market growth and we have also had some nice stability in our market share. Anything you'd like to add?
spk03: Maybe because it's worth mentioning, so some of that shift in promotional activity that you mentioned, we did talk about in the first quarter that there was a destocking that occurred of inventory levels. And when Kerry made remarks and we spoke about it last quarter, we said that would reverse over time. We did see that reversing in the second quarter on a partial basis. And when you think about the reversal of that Q1 destock, you can think about from the U.S. market, that really would reduce by 50% or cut in half. the growth rates we published for the actual results for both Botox and Juvederm. So we saw that partial reversal of that destocking event, and then we will see that continue to unwind throughout the course of the year, especially as we have some of our larger promotional activities in the back half of the year with Botox Day and Juvederm Day. We do see typically an inventory, a stocking uplift from those activities.
spk16: Thanks, Chris. Operator, next question, please.
spk17: Next we'll go to the line of Mohit Bansal from Wells Fargo. Please go ahead.
spk10: Mohit Bansal Great. Thanks for taking my question. I just wanted to talk a little bit about the pipeline in IBD space as well. I mean you have done a bunch of deals and then there has been some movement especially in the oral IBD drugs as well. I mean given your expertise, I would love to understand how do you think about oral pipeline moving beyond the likes of Skyrazy, IL-17s and all, because these drugs are pretty good, but when you think about an oral, what is the ideal profile of the drug that could be a first line drug, which RINVOC could not be, and then when you think about combinations, I mean, what are you exactly looking for? Thank you.
spk07: Hey Mohit, it's Rupal. I can talk about that. With respect to orals, We did do this deal with Landos, and this is our NX13 asset, which we'll anticipate a readout end of this year, beginning of next year. And early data point to good outcomes in ulcerative colitis. And this asset works through NF-kappa-beta, so you'll see what we've observed in preclinical models is reductions in IL-6. IL-1, TNF, interferon gamma. And it's potentially a monotherapy and one that wouldn't have a box warning. So far, the safety data has looked good. But there's also opportunities, we believe, as you mentioned, combination, that you could still combine with Renvoke. And as I mentioned the box warning and in certain geographies, RINVOC is utilized post-anti-TNF. Even with a combo there, there's still opportunity. The second and third line segments in IBD and across immunology continue to grow, and they're getting larger and larger as patients cycle through biosimilar anti-TNFs. We'll see them cycle through, for example, in IBD with IL-1223, like Stelara. So in the future, there's multiple opportunities. And the way we think about these is, do we see an asset that is novel and can address mechanisms that haven't been addressed yet? And can they complement something like RENVOC? So if you see a little bit less efficacy, that may be okay if it's complementary. It may not work necessarily as a monotherapy, but we still see opportunities for combo. And given the other assets that we've talked about that could be IV or sub-Q, we still see a lot of opportunity with Skyrizzy. And a platform study in IBD will kick off later this year looking at various combinations. Many of the assets that I mentioned in the prepared remarks, including a TL1A, including our own internal alpha-4 beta-7, could be added on to Skyrizzy to drive that efficacy even higher, because there's still a bit of a ceiling effect, and I would say the unmet need in IBD in particular continues to be quite high.
spk10: Thank you.
spk17: Operator, next question, please. Next, we'll go to the line of Chris Raymond from Piper Sandler. Please go ahead.
spk19: Thanks. Just another follow-up on Humira. So Jeff and Rob, just hearing your commentary about how when patients discontinue Humira, a number of them are switching to newer biologics. And I think you gave the 20% number going to newer biologics like Skyrizzy and then also, you know, Rinvo. But, you know, we saw some of this happening in the gastro space with one of the checks we did recently. But I wonder if you could provide maybe a little more color on this phenomenon. Is there a particular therapeutic silo where this is maybe happening more extensively? And can you give us a sense as to how this has been you know, influenced or accelerated by biosimilar availability? And just any more color there. Thanks.
spk04: Yeah, thanks for the question. It's almost like a bimodal phenomenon. So the 20% I highlighted, so if you just look from our data, when we just look at the CVS templates, So we can see the degradation of Humira that goes down pretty steeply because, remember, it's an exclusion. So Humira is no longer widely available at all. So most of it happens within the first two or three weeks. And in that one segment, we see that the biosimilar doesn't take up all the Humira loss. And we can see it moving to other mechanisms, particularly Skyrizzy and RENVOQ. So that's within, let's say, the the acute biosimilar event. Now, to Rob's point, what he highlighted is if you take a step back and you look at the macro market, we've started to see in the first quarter and second quarter that the overall molecule, so that's the Adalimab molecule, inclusive of biosimilars, has started to compress faster than it did before there was the availability of this action that was taken by CVS. So it's a doubling of effect. Acutely in the segment that takes place with the exclusion and then the wider market. Now, we're watching this pretty carefully because we obviously haven't seen something like this before in terms of the compression of the molecule. So that's basically the dynamics that we're seeing. And we do think it's because Some physicians or segments of physicians are, they realize that these biosimilars where there's an acute interruption, you know, they want to check how the patients are doing. And if they're not fully in remission when they come in for their appointment, let's say before the switch, sometimes they're transitioned at the rates that I described. So that's sort of the prescriber behavior. Now, where is it coming from? Like, well, we actually see that it is accruing across all of the indications. You know, particularly Humira has quite robust, let's say, base dynamics in the rheumatology indications. But we can see it in Rheum. We can see it in DERM. DERM to Skyrizzy in particular, which is probably not a surprise given the position I highlighted, a 38% share and a 60% in-place share for Skyrizzy and DERM. And we also do see it to some degree in gastroenterology. So to Rob's point, we're going to continue to monitor that. If the overall molecule would continue to compress, obviously there would be, you know, some mitigation of some of it accruing over to Skyrizzy and Renvoke. And so we'll have to continue to see how these weeks and months play out here over the third quarter.
spk16: Thanks, Chris. Operator, next question please.
spk17: Next, we'll go to the line of Gary Nachman from Raymond James. Please go ahead.
spk12: All right, great. Thanks. Can you talk more about how you're managing the growth for SkyRizzy and RynVoke in IBD across both UC and Crohn's, which have both been really strong? And with the SkyRizzy UC launch, is there any cannibalization there with RynVoke? And I guess generally, How do you see those products working synergistically, both in terms of Salesforce and reimbursement, if you see any sort of issues or conflicts there? Thanks.
spk04: Yeah, thank you for the question. A very important question in terms of how we commercialize these. Rupal highlighted it. Obviously, you have the two big indications with two assets within those indications. And so we have constructed, not just in the US but around the world, a very sophisticated approach in terms of multiple sleeves of representatives and medical experts that are representing both drugs across both indications. And it really is, let's say, for example, in our largest market, the US, it's relatively easy to execute because what we see is that our representatives can highlight SkyRisi's data and potential as the obvious frontline agent, which is obviously tremendous data. I mentioned the sequence data. I mentioned our core data. The naive to biologic data you see is absolutely fantastic for the SkyRisi data. And then, really ironically, because of the label changes that took place a few years ago, RINVOC is positioned in later lines. So really, that sort of approach is highly synergistic in terms of we recommend that physicians consider starting with Skyrizzy, and the efficacy will be fantastic, but to Rupal's point, there's still pressure on that disease, and then you have a backstop with tremendous, tremendous data on RINVOC in later lines. And so that's how we position it. We look and we monitor patients. The cannibalization, it's quite modest, and overall when you look at the dynamic of share capture, it's quite encouraging to see how the infield teams and the commercial teams are managing all of those assets. So we're very encouraged about how we've approached the market in terms of our execution, and I think the results are speaking for themselves.
spk16: Thanks, Gary. Operator, next question, please.
spk17: Next, we'll go to the line of Steve Scala from TD Cowan. Please go ahead.
spk05: Thank you. Regarding the 2024 sales guidance, which I realize is about $55 billion, but it implies similar growth in the second half as in the first half, if not a slight deceleration. Why won't total sales do better, and what were your reservations about raising sales guidance today? It seems that across the business, strengths are exceeding challenges. So it would seem not unreasonable to have higher sites now. Second question is, I'm wondering if you can elaborate on the comment, a portion of Humira lives, is a portion of Humira lives closest to a quarter, a half, or three quarters of lives? Thank you.
spk03: Steve, this is Scott. I will talk regarding the revenue. So just to clarify, we did raise the revenue guidance in total from $55 billion to $55.5 billion, a $500 million raise, and that included a $300 million raise for SkyRizzy, a $100 million raise for Renvoke, a $100 million raise for VanClexta, a $200 million spread across other products, and then a $200 million raise reduction in the guidance for aesthetics. So we do see very strong momentum in the business, and we did raise our sales guidance from $55 to $55.5 billion.
spk07: And, Steve, this is Rob. And if you just look at, as I mentioned in my remarks, the first half of the year we've talked about operational growth around 4%. The implied operational growth in the second half, based on our guidance, would be slightly above that and really driven by the Exumair growth platform. which on a reported basis grew more than 18% this quarter. And so we're very pleased with the performance of the business. And I think when you look at the guidance and you do the math, you'll see that the actual implied second half operational growth is slightly higher than the first half.
spk04: And Steve and Jeff, so to give some sense, so we're looking at the coming up on the third year of biosimilar. So the first way to think about it, in the first year of 2023, We had very strong parity access across all the channels. We really exited the year around, I think, 97% or something like that. This year, I think, you know, when we look at all the ins and outs, I think the three-quarter approach is quite reasonable. And as I mentioned in my remarks to earlier one of the questions, it will certainly be lower next year. And I would think that that range would be around that half point. But again, we're not fully complete with all the dynamics. So that gives you some broad spectrum over three years, maybe around the halfway point, plus or minus, as we go into 2025.
spk16: Thanks, Steve. Operator, next question, please.
spk17: Next, we'll go to the line of Truong Huong from UBS. Please go ahead.
spk18: Hi, guys. Truong Huong from UBS. Thanks for taking my questions. Just two from me. Thanks for your comments this year. And you've also moderated your short-term guide accordingly. But you've noted that the long-term 2029 guide remains intact. So with growth around 4% this year in line with that new guide, I imagine next year will be slightly higher. But then it does imply that growth is well into the double digits for 27, 28, and 29 on our calculations. Just what here makes you confident about that level of growth later in the decade? And then secondly, just following up on some of your thoughts on the immunology pipeline, you noted the potential of the utility of multi-specifics in immunology. You've got a pretty strong bispecific platform. Just what are your thoughts on the data that you're seeing here? Is there anything in development that we should be looking at? Thank you.
spk03: This is Scott. I'll start with your question regarding the long-term guidance on aesthetics. So you're right. We've guided to a long-term $9 billion in 2029. And we're not changing that guidance. The guidance changed, as you noted, that I mentioned today is just a short-term guidance change for 2024. We remain very confident in our ability to hit that $9 billion in 2029. When you think about these markets, there's very low penetration in the markets globally. There's a lot of excitement in the space And we expect the market to recover and grow at historical rates. I would say when we look at the market growth, we do see that rebounding and growing well. And then you also should think about there's additional innovation coming that'll drive that. So we have some of the additional indications of Botox that Rupal walked through, as well as the quick onset short-acting toxin Bonti that will also drive additional market growth. And so we continue to feel very comfortable with our ability to achieve that on a long-term basis in 2029.
spk07: I'll take the next question on the pipeline. So we continue to be excited about bispecifics, in particular ludicizumab. And it's an IL-1 alpha and importantly also 1 beta. And this we believe distinguishes it from earlier generation assets that were singular and let's say only took out IL-1 alpha. We see, I would say, very, very strong benefits in hydradenitis supertiva, and I don't think that was observed as a pure monoclonal. And the efficacy that we're seeing is in a 100% anti-TNF failure population and very sick, early stage 3, 70%. It was one of the most severe, probably the most severe ever studied efficacy. So we think there continues to be potential in the bispecific space as you take out multiple cytokines. The way to address it is through engineering of the assets. The other way is combination, so we can get to that bispecific approach through combos. And then thirdly, I would say earlier in the pipeline is the multispecific approach, which The advantage that could provide is you maintain your bispecific approach, but then a third arm, let's say, can target specific cells. And that could further enhance efficacy and, in particular, safety. And we're looking at that approach in immunology and as well in oncology. And that was reflected in our partnership with Tentarex.
spk16: Thank you, Trang. Operator, next question, please.
spk17: Next, we'll go to the line of Evan Siegerman from BMO Capital Markets. Please go ahead.
spk08: Hey, guys. Thank you so much for taking my question, and a really, really helpful update today. So just looking at kind of the expected growth. Can you speak up just a little bit? Sorry. All right. Can you guys hear me all right? Does that work? Good. It's still faint, but we'll do our best. All right, sorry about that. I'll speak very loudly. So when looking at expected growth for Rayla over the next few quarters, can you comment on what type of impact you think new competitors to the NBD market might have and what you can do to help maintain a growth position going forward?
spk04: Yeah, hi, it's Jeff. You know, we're very pleased with how both of the indications are performing, and we monitor them very carefully, certainly with bipolar and AMDD. So when we look at our, you know, quarterly surveys of our target physicians and really our whole call cycle, we can see now that Raylar is the most preferred agent overall for bipolar disease based on its indication set, its tolerability, its efficacy, et cetera. And we've really gone to the very top of the league table for AMDD as well. So if we look overall on our demand, you know, we're tracking, you know, above 20% in terms of the push. We continue to focus our team and, where necessary, add share of voice in terms of our sales force. So we're quite comfortable that we can continue to grow our share, which has been growing very, very nicely, particularly on the MBRX side, and certainly face the competitive dynamics and navigate those as we go forward.
spk07: Jeff, maybe to add, it's Rupal here. There is going to be competition, but What we see as a benefit clinically for Vrelar is that full spectrum coverage in bipolar. And when you're able to take mania, you don't need an adjunctive therapy for that. So that's a big advantage. The other thing that we continue to hear and probably reflected in our data is the really limited impact on fatigue and sedation. And so what we're hearing is with Vrelar, patients really don't have to sacrifice their daytime productivity in order to gain that benefit. And then the other benefit I would say with Vralar is flexible, adjustable dosing. So these things together I think underlie what Jeff was speaking about.
spk16: Thanks Evan. Operator, next question please.
spk17: Next we'll go to the line of James Shin from Deutsche Bank. Please go ahead.
spk09: Hi, good morning. Thanks for taking our question. You mentioned some of the Humira contracts go into 2025. Does that also apply to SkyRizzy and Renvoke? And that's what gives you visibility on the low single-digit price erosion? And secondly, has the introduction of co-branded Humira and now that PBMs are more intertwined with biosimilars changed the negotiation dynamics at all? Thank you.
spk04: Yeah, so typically, you know, again, in some cases we are able to secure, you know, multi-year contracts. And as you can imagine, that we would do that for the portfolio, basically, the way that our products work. So that does help with the visibility in terms of what our access would look like for 25 as well as the pricing dynamics. Again, I want to clarify that the negotiating season is not fully complete, but the dynamics are progressing as I highlighted there. So yes, to your first question. The other dynamic in terms of Cordavis, I'm not sure that that's actually changing the dynamics in terms of the negotiations overall. That was obviously a volume-related deal with CVS that we announced over a year ago, or almost a year ago now, so it doesn't necessarily play into other negotiations. Each of these payers and and pharmacy benefit managers, they have their own ideas in terms of how they want to approach the INI category and certainly the emergence of the Humira biosimilars. So it's a CVS unique dynamic.
spk16: Thanks, James. We have time for one final question, operator.
spk17: For our last question, we'll go to the line of Louise Chen from Cantor Fitzgerald. Please go ahead.
spk14: Hi, thanks for taking my questions here. So I wanted to first ask you, do you still feel that your aesthetics business is a good strategic asset for you? And if so, where do you see the synergies within your organization? And second question I wanted to ask you is how you think pharma will fare under a Democratic versus a Republican presidency and how you're going to navigate through that uncertainty in the near term. Thank you.
spk07: Luis, this is Rob. I'll take your question. We like the aesthetics business when you think about the growth profile, the profitability. We have set it up as a fully integrated standalone unit because it behaves differently than the therapeutics business. We think we've actually seen, since we announced the transaction, really strong performance. We've exceeded our deal model expectations since we announced the deal. So we think it's operating very well. Obviously, we're working through some macroeconomic headwinds, but when you look at, for example, share performance, We had the entry of Daxify last year, and we did not lose any share. I think a lot of investors were concerned that we'd see considerable share loss. And so I think the team has done a remarkable job of competing in this marketplace, going through a period with economic headwinds. We're still very confident, given low penetration rates, given our relationship in the field, the potential innovations that we plan to bring forward. It has a very nice fit, and you think about just from a profitability and a growth standpoint, you know, fits the profile we're looking for. So I certainly feel it's a nice fit for the company. As it relates to the election, look, it's hard to handicap it, whether it's Democrat or Republican. If you think about, you know, we've obviously contemplated the Inflation Reduction Act, We've come out and said that even with modeling that impact in, that we still expect to deliver on our long-term outlook. Now, I will say our view on the IRA from a policy perspective is we're certainly in favor of the Part D benefit redesign since it helps address patient out-of-pocket burden, but the price-setting provisions in the IRA certainly harm long-term innovation in our industry. So we are hopeful that, you know, if it's a new administration or the current administration, that they'll reassess those provisions that ultimately are harmful for long-term patient care in the U.S. I mean, it clearly takes away the incentive to launch in later lines of smaller patient populations, which is really a very unfortunate negative outcome for the legislation. The way I view it is addressing patient out-of-pocket burden is good policy, but taking away the incentive for innovation is not, and my hope is under either administration that will be reconsidered.
spk16: Thanks, Louise. That concludes today's conference call. If you'd like to listen to a replay of the call, please visit our website at investors.abbey.com. Thanks again for joining us.
spk17: Thank you all for joining the Abbey Second Quarter 2024 Earnings Conference Call. That concludes today's conference. Please disconnect at this time and have a wonderful rest of your day.
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