AbbVie Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
April 26, 2024

There are 20 speakers on the call.

Operator

Good morning and thank you for standing by. Welcome to the AbbVie First Quarter 2024 Earnings Conference Call. All participants will be able to listen only until the question and answer portion of this call. Today's call is also being recorded. If you have any objections, you may disconnect at this time.

Operator

I would now like to introduce Ms. Liz Shea, Senior Vice President of Investor Relations. Ma'am, you may begin.

Speaker 1

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 Thacker, Senior Vice President, Chief Medical Officer, Global Therapeutics. Joining us for the Q and 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. 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.

Speaker 1

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 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.

Speaker 1

So with that, I'll turn the call over to Rick.

Speaker 2

Thank you, Liz. Good morning, everyone, and thank you for joining us today. I'm extremely pleased with our start to 2024 with Q1 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 1st CEO, I have decided to retire from the role effective July 1st this year and will continue to serve AbbVie as Executive Chairman of the Board.

Speaker 2

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.

Speaker 2

We have built an outstanding company culture, an important priority and competitive advantage. And our productive R and 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.

Speaker 2

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 to $55,000,000,000 Our to $55,000,000,000 Our market capitalization has increased substantially from $54,000,000,000 to roughly $300,000,000,000 today. We have achieved a total shareholder return of more than 6.75%, which is top tier relative to our peers.

Speaker 2

And importantly, we have substantially increased our investments in R and 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.

Speaker 2

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?

Speaker 3

Thank you, Rick. Before I comment on our Q1 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. Abi's outlook is very strong, and I am excited about the remarkable impact that we will continue to have on patients' lives.

Speaker 3

Turning to Q1 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 $0.11 above our guidance midpoint. Total net revenues were $12,300,000,000 approximately $400,000,000 ahead of our expectations. This overachievement was driven by our ex HUMIRA growth platform, which delivered revenue growth of more than 15% quarter and includes continued robust sales from SKYRIZI and RINVOC with combined growth above 50% in their 5th full year on the market, as well as double digit revenue growth from several other key products including VENCLEXTA, VRAYLAR, UBRELVI and CULIPTA.

Speaker 3

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 Cerevel, which we anticipate will close in the middle of the year.

Speaker 3

Cerevel's pipeline of differentiated assets will further augment our neuroscience portfolio. In addition, we continue to advance our R and D pipeline and invest for long term growth. This progress includes the FDA's full approval of elliher 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.

Speaker 3

Approval of Juvederm Voluma XC for Temple Hollows, further strengthening our leadership in 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 $0.16 and now expect adjusted EPS between $11.13 $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 CAGR through the end of the decade. With that, I'll turn the call over to Jeff for additional comments on our commercial highlights.

Speaker 3

Jeff?

Speaker 4

Thank you, Rob. I'll start with the quarterly results for immunology, which delivered total revenues of approximately 5 $400,000,000 exceeding our expectations. TYRISI global sales were $2,000,000,000 reflecting operational growth of 48%. We continue to see exceptional momentum across all of the approved indications. In psoriasis, Gyrogyz is the clear market leader in the U.

Speaker 4

S. 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 1 out of every 4 new or switching in play biologic patients. Globally, SKYRIZI has achieved psoriatic in play share leadership in nearly 30 key countries.

Speaker 4

In IBD, SKYRIZI is on track to add more than $1,000,000,000 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 U. S. And Japan as well as other key markets around the world.

Speaker 4

And finally, we are preparing for the launch of SKYRIZI in 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 SKYRIZI in Crohn's and the exceptional bio naive data we have generated in UC, we anticipate a strong launch.

Speaker 4

Turning now to RINVOC with global sales of approximately $1,100,000,000 reflecting operational growth of 61.9%. In room, we continue to see strong prescription growth across each of the 4 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 LevelUp, our 2nd head to head study in AD. LEVEL UP demonstrated RINVOX 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.

Speaker 4

We anticipate these strong head to head results will support additional share capture, especially given RINVOX label use in the U. S, which requires that initiation with a 15 milligram dose. And in IBD, RINVOQ's uptake continues to be very strong. RINVOQ 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 2nd line plus growing even faster as patients cycle to newer higher efficacy agents like RINVOQ and IBD.

Speaker 4

Turning now to HUMIRA, which delivered global sales of approximately $2,300,000,000 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.

Speaker 4

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 $1,500,000,000 exceeding our expectations.

Speaker 4

IMBRUVICA global revenues were $838,000,000 down 4.5%, reflecting continued competitive pressure in CLL. VENCLEXTA global sales were $614,000,000 up 16.3% on an operational basis and we are seeing robust momentum internationally with strong performance for both CLL and AML. Elahir generated $64,000,000 of sales to AbbVie, reflecting a partial quarter of revenue following the February close of the ImmunoGen acquisition. The Elohire 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 elahir uptake.

Speaker 4

Lastly, the global launch of BEP Kinley 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 $2,000,000,000 up 16% on an operational basis, again, ahead of our expectations. This robust performance is driven by continued double digit growth of VRAYLAR with global sales of $694,000,000 UBRELVI with total revenue of $203,000,000 and Culipta with global sales of $131,000,000 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 $748,000,000 up 4.5% on an operational basis.

Speaker 4

And finally, we are very excited about 951, which will be commercialized as Vialav in the U. S. 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.

Speaker 4

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 Keri for additional comments on aesthetics. Keri?

Speaker 5

Thank you, Jeff. 1st quarter global aesthetics sales were over $1,200,000,000 reflecting a modest decline on an operational basis. In the U. S, aesthetic sales of $776,000,000 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.

Speaker 5

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 2020 2. From a competitive perspective, our U. S. Aesthetics portfolio continues to perform well.

Speaker 5

Market share for both BOTOX Cosmetic and Juvederm was stable in the Q1 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 2nd quarter.

Speaker 5

We therefore expect inventory levels to normalize in the Q2 and remain on track to deliver full year aesthetics sales growth in the U. S. Internationally, 1st quarter aesthetics sales were $473,000,000 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 Q1 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.

Speaker 5

Our pipeline continues to generate important new assets. Uptake of our recently launched Volex and SkinVive products remain 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 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.

Speaker 5

We also remain on track to submit a new drug application for our short acting toxin, SPONTA 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, Font E 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 Rupl.

Speaker 6

Thank you, Carrie. I'll start with immunology. We recently announced positive top line results from 2 Phase 3 studies for RINVOC dermatology and rheumatology. In the LEVEL UP study, which evaluated RINVOQ against dupilumab in atopic dermatitis, RINVOQ demonstrated superiority on the primary endpoint at week 16, which was a composite endpoint measuring skin clearance and itch reduction. Twice as many RINVOC patients achieved this very stringent endpoint compared to dupilumab.

Speaker 6

RINVOC also demonstrated superiority on all rank secondary endpoints in this trial. LEVEL UP was a study in which patients started on RINVOC 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 RINVOQ demonstrating superiority on itch as early as week 2 and on skin lesions as early as week 4. RINVOX safety profile in the LEVEL UP trial was consistent with what has been observed in previous studies.

Speaker 6

There were no serious infections in patients treated with RINVOQ 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 3 studies, we remain very confident in Brinvoeg'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 3 select giant cell arthritis trial, which evaluated RINVOQ in combination with a 26 week steroid taper regimen compared to patients receiving placebo in combination with a 52 week steroid taper.

Speaker 6

In the study, RINVOQ 15 milligrams met the primary and key secondary endpoint, demonstrating superiority cumulative steroid exposure at week 52. Importantly, RINVOX 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 RINVOX 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 rainbow carb, while there were 2 in the placebo group.

Speaker 6

Based on the results from the select GCA trial, we believe RINVOQ 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 2 study for ludikizumab in ulcerative colitis, The start of our Phase 2 Crohn's disease platform study, which will evaluate combinations of SKYRIZI with ludikizumab and other novel biologics. And we remain on track for approval decisions for SKYRIZI in ulcerative colitis with the U.

Speaker 6

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 pipeline as evidenced by 4 deals that we announced in the Q1. These include the acquisition of Landoz Biopharma, which brings an oral NLRx1 agonist currently in Phase 2 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 Centerix Biotherapeutics to develop conditionally active, multi specific biologics in immunology and oncology.

Speaker 6

We are excited to partner with these companies who are all pursuing very innovative approaches to developing transformative therapies. Moving to oncology, where 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 3 prior therapies. This conversion to full approval was based on data from the confirmatory Phase 3 Mirasol trial, where ELOHIR 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 2 PIKOLO study evaluating ELOHIR as a monotherapy and FR alpha positive third line the second half of the year from a potentially registration enabling Phase 2 trial for our CD123 targeting ADC, PIVEC in a rare blood cancer called blastic plasmacytoid dendritic cell neoplasm.

Speaker 6

Now moving to program updates in hematologic oncology. Based on the totality of the data from our TRANSFORM-one trial and following recent feedback from regulators, we will not be submitting niviteclax for approval in myelofibrosis and we will wind down the TRANSFORM-two 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 U. S. And Europe for Abkinley in relapsedrefractory follicular lymphoma.

Speaker 6

The Phase 3 readout from the VENCLEXTA VIRONA trial in treatment naive higher risk MDS and initiation of a Phase 3 monotherapy study for ABBV383 in 3rd 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 BONTI in the second half of the year. Our rapid onset short acting toxin has a highly differentiated clinical profile compared to currently available neurotoxin.

Speaker 6

Font D 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 Q2.

Speaker 6

As Rob mentioned, we remain on track to close the Cerevel transaction in the middle of this year. Cerevel recently announced positive top line results from their Phase 3 TEMPO-three trial evaluating tivapadon as adjunctive therapy to levodopa in patients with Parkinson's disease. In the study, tavapadon 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. Vapadon also met the key secondary endpoint in the trial providing a significant reduction in off time compared to levodopa and placebo. 2 additional Phase 3 studies for tivapadon in Parkinson's disease are expected to read out later this year.

Speaker 6

The emiraclatine 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.

Speaker 7

Thank you, Rupal. Starting with our Q1 results, we reported adjusted earnings per share of $2.31 which is $0.11 above our guidance midpoint. These results include an $0.08 unfavorable impact from acquired IP R and D expense. Total net revenues were $12,300,000,000 $400,000,000 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 ex HUMIRA growth platform.

Speaker 7

The adjusted operating margin ratio was 42.2 percent of sales. This includes adjusted gross margin of 82.9%, adjusted R and D expense of 14.7%, acquired IP R and D expense of 1.3% and adjusted SG and A expense of 24.6%. Adjusted net interest expense was $429,000,000 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 $11.33 This increase of 0.16 dollars at the midpoint includes $0.26 of operating over performance, partially offset by $0.10 of higher dilution due to the earlier close of ImmunoGen.

Speaker 7

As previously communicated, this earnings per share guidance includes $0.42 of dilution related to the recently closed acquisition of ImmunGen and the pending acquisition of Cerevel. Please also note that this guidance does not include an estimate for acquired IP R and D expense that may be incurred beyond the Q1. We now expect total net revenues of approximately $55,000,000,000 an increase of $800,000,000 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 ex HUMIRA growth platform. We now expect SKYRIZI global revenue of $10,700,000,000 an increase of $200,000,000 due to strong momentum across all approved indications.

Speaker 7

RINVOG total sales of $5,600,000,000 an increase of $100,000,000 reflecting robust uptake in IBD. IMBRUVICA total revenue of $3,100,000,000 an increase of $200,000,000 reflecting lower erosion. And Elahir total sales to AbbVie of $450,000,000 an increase of roughly $200,000,000 reflecting a partial year of revenue following the February close of the ImmunoGen acquisition. Moving to the P and L for 2024. We continue to forecast adjusted gross margin of approximately 84% of sales, adjusted R and D investment of 14%, adjusted SG and A expense of 23.5% and an adjusted operating margin ratio of roughly 46.5%.

Speaker 7

We now expect adjusted net interest expense of $2,200,000,000 which includes the partial year cost in 2024 to finance the ImmunoGen and Cerevel transactions. Turning to the 2nd quarter, we anticipate net revenues of approximately $14,000,000,000 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.

Speaker 7

We are forecasting adjusted operating margin ratio of approximately 49 point 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 $3.09 This guidance does not include acquired IPR and 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.

Speaker 1

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 Operator, first question please.

Operator

Yes. The first question comes from Mohit Bansal with Wells Fargo. Your line is open.

Speaker 8

Great. Thank you very much for taking my question and congrats on the progress and congrats to Rob as well. So maybe let's just start with 2024. I mean, so thanks for the guidance. But when we look from 2024 to 2025, there are a couple of headwinds that you have highlighted in the past.

Speaker 8

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, 2024 versus 2025? And could you give us some confidence that you can continue to grow in 2025 despite these headwinds from IRA and HUMIRA? Thank you.

Speaker 3

So Mohit, this is Rob. I'll take that question. So if you think about 24 and 25, I mean clearly the ex HUMIRA growth platform is demonstrating great momentum. If you just think about SKYRIZI and REMOKE alone are growing by more than $4,000,000,000 per year. Aesthetics will recover to high single digit growth.

Speaker 3

Our neuroscience franchise will grow by over $1,000,000,000 this year on the heels of strong momentum for VRAYLAR and our migraine portfolio and we will have incremental contributions from VIALEV and ELI here in 2025. 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 2025.

Speaker 3

But keep in mind for us, the IRA impact really hits us in 2025 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 you think about it is despite that headwind in 2025, 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.

Speaker 3

And keep in mind that we essentially would have think of it as a roughly half year for Cereval and 10.5 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 annualization impact. But then when you get to 26 and beyond, you have even faster revenue growth and very robust earnings growth.

Speaker 3

So that's probably the best way to think about the profile of the company. But when you look at that ex HUMIRA growth platform, there's a lot of momentum there and we are very well positioned to deliver very robust growth.

Speaker 8

Super helpful. Thank you.

Speaker 1

Thanks, Mohit. Operator, next question please.

Operator

The next question is from Vamil Divan with Guggenheim. Your line is open.

Speaker 9

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?

Speaker 9

You mentioned some shift in promotional efforts to the 2nd 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. And 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? Maybe just kind of why the decision was made would be helpful to give us some comfort on the outlook there.

Speaker 9

Thanks.

Speaker 5

Hi, this is Carrie. Thanks for the question. So 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 past few quarters as we launch our new products.

Speaker 5

So like you said, those fundamentals are in line with our expectations. As we were going through the quarter, we really realized that 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.

Speaker 5

And I'll let Scott address the rest of that question.

Speaker 7

Sure. Thanks, Carrie. So Bumble, to quantify the inventory impact in the Q1, it was a little bit more than $50,000,000 between Juvederm and BOTOX. And you can think of that as being split roughly 2 thirds to BOTOX and 1 third to Juvederm. And think as Carrie mentioned in her remarks, that impact of that inventory will we expect that to turn into 2nd quarter.

Speaker 1

Thanks, Vamil. Operator, next question please.

Operator

Yes. Our next question comes from Chris Shibutani with Goldman Sachs. Your line is open.

Speaker 10

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?

Speaker 10

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 to play out How you're approaching contracting for the forward? Thank you.

Speaker 4

Yes. Hi, Chris. This is Jeff. So the contracting season typically starts April or May. And frankly, as we've highlighted before, it can run-in the immunology category really through the end of the year.

Speaker 4

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.

Speaker 4

We seek multiyear contracts with our payers to try to establish the relationship, the pricing, etcetera. 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 willy nilly discarded. And so it is a long term in some cases partnership over a couple of years with these payers.

Speaker 4

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 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 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 2025. But we've been quite successful in maintaining good access for our brands and certainly HUMIRA is tracking in line with our expectations.

Speaker 1

Thanks, Chris. Operator, next question please.

Operator

Our next question comes from Chris Schott with JPMorgan. Your line is open.

Speaker 11

Great. Thanks so much. Just a couple more on the HUMIRA front. I think 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 that we're seeing more volume erosion, particularly with the CVS book of business.

Speaker 11

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, etcetera. 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 on a related topic, can you talk 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?

Speaker 11

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.

Speaker 4

Yes. 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.

Speaker 4

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, 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.

Speaker 4

Now one of the things in my remarks I often talk about new to brand or in play share capture. And that's a really good way to look at performance particularly early in launch cycles when you're looking at capture rate or competitive dynamics. I think it's important 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 Cosentyx Taltz analog or Taltz was advantaged in ESI for Cosentyx back in 2019.

Speaker 4

And we see that typically in this category almost 90% of the erosion tracks within the 1st 2 to 3 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 NBRx, 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.

Speaker 4

And if you look at the 1st 2 weeks, it's pretty meaningful. Over 20 percent of the HUMIRA prescriptions are moving to other mechanisms of actions, including SKYRIZI and RINVOC. 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 physicians' 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?

Speaker 4

And that's actually what we see playing out in 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 SKYRIZI 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 2024, we have very solid contracts with our payers through 2024. And remember that these payers can add biosimilars at parity whenever they choose.

Speaker 4

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.

Speaker 4

And we do see that some select plans may take another approach, which we've 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.

Speaker 4

We're quite interested in the 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. The tail. The tail. Okay.

Speaker 4

So the tail, 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 will probably become more apparent as we move through 2025 where that tail may sit. And we've highlighted that it may start to emerge in 2025 and probably be much more visible by 2026.

Speaker 4

And that's going to ultimately depend on how over the course of 'twenty five the price volume fully plays out in the marketplace.

Speaker 3

And Chris, this is Rob. On your question regarding the guidance this year, I think it's important to know, yes, we've said that 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.

Speaker 3

So you would expect price erosion to 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.

Speaker 3

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. I think we made some prudent assumptions on potentially other impacts. But overall, we're still tracking in line with that guidance.

Speaker 1

Thanks, Chris. Operator, next question please.

Operator

Yes. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open.

Speaker 12

Thanks so much for taking the questions and congrats to Rick and best of luck to Rob in a new role. Just wondering if you could maybe frame a little bit for us the opportunity for SKYRIZI in UC versus Crohn's disease. I think last time we heard from J and J, Crohn's represented about $7,000,000,000 of STELARIS 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?

Speaker 12

And then when you were talking through some of the latest RINVOC 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 of therapy on the label at some point or if we shouldn't think about that as a possibility? Thank you.

Speaker 4

Yes. Thanks, Terrance. It's Jeff. I'll take the first question. So Crohn's is larger than you I mean, if you look at the overall market or revenue, I think it's 65%, 70%.

Speaker 4

So it's Crohn's is very, very significant. Having said that, ulcerative colitis is a multibillion dollar opportunity for us. It's still a very, very underpenetrated 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 SKYRIZI.

Speaker 4

And what's remarkable, we studied a very, very difficult population in ulcerative colitis, but we still had, 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.

Speaker 4

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.

Speaker 6

Yes. Thank you. So 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. Now from a health authority standpoint, I think the position there is that you have this oral surveillance study with tofacitinib and they're going to apply those findings to the other assets in a similar class probably until there's another outcome study to sort of argue against that.

Speaker 6

And that's kind of how we see it. Now that's in the U. S. 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.

Speaker 6

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

Speaker 4

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 second and third line is still a huge opportunity and we'll continue to grow with this emerging data. And Terence, it's Jeff again. One more comment.

Speaker 4

I mentioned how we're excited about the naive position for both SKYRIZI, CD and UC coming. But what's also nice is those same representatives are in the office and are able to highlight basically a 1, 2 punch where you use SKYRIZI first in earlier lines based on this exquisite data. And then obviously for later lines you can use RINVOC. 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 percent of all in play share with SKYRIZI 1st and RINVOC 2nd. So it's an encouraging position as we fill out that portfolio.

Speaker 1

Thanks, Terrence. Operator, next question please.

Operator

The next question comes from Carter Gould with Barclays. Your line is open.

Speaker 13

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 that I guess appropriately kind of capturing all the volume you're really seeing? And there's clearly, with your part of your agreement with CVS and the Cord Davis there, there is the potential for some HUMIRA volume to potentially be shifting there.

Speaker 13

Is that being captured by TRx? So I guess any commentary there on sort of the accuracy of that data that we're all seeing? And then maybe if you could just go back and wanted to circle back on the EPS commentary on 25, percent, sort of like the way you frame that growth. Is that sort of ex IPR and D? Any color there would be appreciated.

Speaker 13

Thank you.

Speaker 4

Yes. It's a great So it's early, but we believe the data is accurate. I mean, if you look at the 1st 2 weeks to give you some sense and this is inclusive of the Cordovis HUMIRA, There was a downdraft of about 13,000 prescriptions for HUMIRA from baseline. And the biosimilars captured about, which was primarily the Cordovis Heramos 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 SKYRIZI and RINVOC.

Speaker 4

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.

Speaker 4

Where that ultimately lands, we'll have to see. Again, I want to reiterate the pure HUMIRA downdraft within line with what we assumed and we are seeing this other market behavior that's taking place.

Speaker 3

Carter, this is Rob. Just to clarify on my earlier comments, yes, it is ex IPR and D. We always guide to ex IPR and D. What I was trying to highlight is you should expect robust revenue growth in 2025 and that growth accelerating in 2016 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 25 being that we will have an annualization impact from that interest expense.

Speaker 3

We will still deliver at 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 that have that dynamic in 2025 that's important for your modeling.

Speaker 1

Thanks, Carter. Operator, next question please.

Operator

Our next question comes from Simon Baker with Redburn Atlantic. Your line is open.

Speaker 14

Thank you for taking my questions. Two quick ones, if I may. Just going back to HUMIRA, 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.

Speaker 14

And then secondly, on Wimvok and the LevelUp deal LevelUp data. I wonder how you see the competitive dynamics evolving in that space. Is this about switches or is this about market expectation expansion? I ask because this morning Sanofi said that they welcome competition as a way of expanding the number of people treated in an area that's still relatively unpenetrated. So I just wonder how you see the opportunity commercially?

Speaker 14

Thanks so much.

Speaker 4

Yes. Thank you for the questions. It's Jeff again. I would say that we're not anticipating like a wholesale restructure of the PBM industry, for example. I mean, we certainly think that there's very reasonable chance of sort of transparency reform, exactly how some of the economics are working, maybe transparencies to the government or downstream to the clients, that's very possible.

Speaker 4

But a major wholesale change, we don't see that happening in the near term. Obviously, we are 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 biopeneration or oral and biopeneration. It's really only about 4% or 5%.

Speaker 4

So I think Sanofi's comments are very well timed. I mean this marketplace is going to grow significantly as this innovation is able to be delivered to the global population with this very serious disease. But we also think this LevelUp study is good for our market share penetration. And I'll give you some perspective. Our U.

Speaker 4

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.

Speaker 4

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 LevelUp.

Speaker 4

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 hope that helps.

Speaker 1

Thanks, Simon. Operator, next question please.

Operator

Our next question comes from Tim Anderson with Wolfe Research. Your line is open.

Speaker 15

Thank you so much. I have questions on contracting for SKYRIZION25. How many lives do you already have locked up through your general multiyear 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 SKYRIZI. But under the idea that while SKYRIZI is better, something like HUMIRA or biosimilar Stelara might be just fine.

Speaker 15

That same argument can be made in the statin category, for example. Crestor is the best, Zocor might do just fine. Thanks.

Speaker 4

Yes. I think we'll probably pass on the number of lives locked up. I mean, we are confident given the market position, Tim, of SKYRIZI and RINVOQ. I think in particular around the momentum that we have across the SKYRIZI indication, that we're going to have I

Speaker 8

think

Speaker 4

the other thing I think the other thing that we've highlighted is, I'm very pleased with how the adoption of SKYRIZI 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 basically electronic prescribing because the ability to get these very sensitive patients under significant control, The world's really never seen anything like the 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

Speaker 7

to STELARA.

Speaker 1

Thanks, Tim. Operator, next question please.

Operator

Yes. Our next question comes from Louisa Hector with Berenberg. Your line is open.

Speaker 5

Thank you very much for taking my question. It's on Elerhia. I wonder whether you might be able to tell us the full quarter of sales. And then any commentary around penetration rate of ELAHERE and how much off label use you think may be happening with the guideline inclusion? Thank you.

Speaker 7

Sure. Thanks, Lisa. It's Scott. With respect to the LAHERE 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, dollars 70,000,000 I'm sorry, dollars 110,000,000 in the full quarter, dollars 113,000,000 in the full quarter.

Speaker 4

And it's Jeff. What we also see in the marketplace, a big catalyst that we saw in the Q1 was the movement from the accelerated approval to the full approval that Rupl highlighted with the Mirasol 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 going to be very positive to continue the growth rates through the rest of the year. In terms of off label, that's difficult to say.

Speaker 4

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 populations that are coming in terms of the ovarian cancer marketplace.

Speaker 1

Thanks, Louisa. Operator, next question please.

Operator

Yes. The next question comes from Gary Nachman with Raymond James. Your line is open.

Speaker 16

Thanks. Good morning. Looking at the strong performance of the neuro franchise of VRAYLAR and migraine in particular, talk about the competitive dynamics there in those markets and how did the gross to net impact you in 1Q versus what you expected and how should that trend for the rest of the year? And then with respect to Cerevel, just 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 imracludine and Vraylar, just the latest thinking on that based on your conversations with FTC? Thanks.

Speaker 4

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. We continue to be the new to brand share leader in BOTOX for chronic migraine and we see that Culipta is accelerating significantly.

Speaker 4

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 Liptus. So Q Liptus is really clearly taking over the market leadership position among the injectable and the oral CGRPs. UBRELVI continues to have a very meaningful and substantial lead over GRAYLAR continues to perform very well, ongoing market growth.

Speaker 4

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 lead 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 We also feel that the gross to net, our vouchers, our co pay, which sometimes can get little funky in the Q1, We have strong controls there and we're seeing a lot of stability. So overall those businesses are performing very well.

Speaker 3

Gary, I'll take your question. This is Rob. I'll take your question on the FTC. 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 VRAYLAR share in schizophrenia is very low.

Speaker 3

The vast majority of VRAYLAR sales comes from the bipolar and AMDD indications. In the case of davapadon, it will serve the early Parkinson segment, which duodopa and bileb 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.

Speaker 1

Thanks, Gary. Operator, next question please.

Operator

Yes. The next question comes from Steve Scala with TD Cowen. Your line is open.

Speaker 17

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.

Speaker 17

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 3 months ago.

Speaker 17

And is that in part maybe due to the accretive news from yesterday? So that's a big that's a long question, but that's only one question. The second question is curious if the FDA has contacted Epti about the potential safety issues with emlacridine post the competitor issue with convulsions and rabbits? And have you seen this with your agent? Thank you.

Speaker 4

Yes. So it's Jeff. So I'll try to take that. So the first part was the Q1, 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 after 3 weeks, we look at our model in terms of the expectation around retention of HUMIRA with the CVS template.

Speaker 4

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, is going to other mechanisms, including SKYRIZI and Renvok. So overall, as we look to the balance of the really the Q1, what we're seeing play out in the Q2 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.

Speaker 3

Yes. 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 guide.

Speaker 3

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 the price erosion is the vast majority of the decline, but there is volume and it's tracking exactly as we anticipated. So there is an additional downside here. And as Jeff mentioned, we did have slightly better performance in the Q1. But again, it was I mean, I think to the tune of $30,000,000 to $40,000,000 on this book of business, not overly material, but ahead of the initial expectation.

Speaker 6

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.

Speaker 6

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.

Speaker 3

Hey Steve, this is Rob. I'm going to come back to your previous question and maybe I understand where the confusion 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.

Speaker 3

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 2nd quarter, which is lower than it was around 40% in the quarter. So naturally you'd wonder why would you have less erosion.

Speaker 3

There's that year over year dynamic, but that was how we planned the year. We anticipated because we knew about the change that was coming in April 1. 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.

Speaker 1

Thanks, Steve. Operator, next question please.

Operator

Yes. Our next question comes from Trung Huong with UBS. Your line is open.

Speaker 18

Hi, guys. Trung Huong Huong from UBS. Congratulations, Rick, on the next chapter of EBITDA Life and Rob for moving AbbVie forward. Again on biosimilar 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're giving away more price to CVS at the contract at the time?

Speaker 18

And you mentioned additional contracts moving to biosimilar 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.

Speaker 8

Tarun, this

Speaker 7

is Scott. I'll start with your question regarding the price associated with that. And you can think of this 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.

Speaker 7

So that's what that relates to.

Speaker 4

Yes. 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.

Speaker 4

So if you were to see that, you shouldn't be surprised about that and that would be within the contemplated approaches that we're taking as we look across 24 with our knowledge of what's happening in the marketplace.

Speaker 1

Thanks, Truong. Operator, we have time for one final question.

Operator

Okay. And our final question comes from Evan Sigerman with BMO Capital Markets. Your line is open.

Speaker 19

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 SKYRIZI.

Speaker 19

Last quarter you disclosed the $1,900,000,000 cash payment for royalties. Can you provide us any color on what this quarter's royalty was? And I believe that was

Speaker 4

for the full year last year, but maybe just

Speaker 6

for this quarter. Thank you.

Speaker 5

Hi, this is Peri. 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 market until the recovery starts to begin in the second half of twenty twenty four. 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.

Speaker 7

Hi, it's Scott. So you're right. With respect to the SKUs 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 $1,000,000 was the amount in the Q1 that we paid in cash payment.

Speaker 1

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. Abbvie.com. Thanks again for joining us.

Operator

Thank you. That concludes today's conference. You may all disconnect at this time.

Powered by Quartr
Earnings Conference Call
AbbVie Q1 2024
00:00 / 00:00