AbbVie Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
July 27, 2023

There are 17 speakers on the call.

Operator

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 and Chief Commercial Officer Scott Rentz, Executive Vice President and Chief Financial Officer Terry Strom, Senior Vice President, AbbVie and President, Global Allergan Aesthetics and Tom Hudson, Senior Vice President, R and D and Chief Scientific Officer. Joining us for the Q and A portion of the call is Rupal Thakkar, Senior Vice President, Development and Regulatory Affairs and Chief Medical Officer. Before we get started, I'll note that some Statements we make today may be considered forward looking statements based on our current expectations. 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.

Operator

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 to understand AbbVie'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.

Operator

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

Speaker 1

Thank you, Liz. Good morning, everyone, and thank you for joining us today. 2023 is an important year for AbbVie As we experience HUMIRA Biosimilar Competition in the U. S. Market and as we execute our long term diversification growth strategy.

Speaker 1

Now roughly 7 months into the year, I'm extremely pleased with the progress that we're making against these objectives. The U. S. HUMIRA biosimilar impact is playing out as projected and slightly better than our planning assumptions. We are competing very effectively with the various biosimilar offerings.

Speaker 1

We have exceeded our guidance in both 1st and second quarters With the overachievement predominantly driven by our growth platform, the base portfolio excluding HUMIRA, which as you know is the critical driver in our rapid return to growth in 2025 and beyond. To that point, this platform demonstrated operational revenue growth of nearly 8% this quarter, with growth expected to further accelerate in the second half of this year. We're also once again raising our full year revenue guidance by $1,000,000,000 Which is on top of the $400,000,000 sales increase we delivered in the Q1 for a total overachievement of $1,400,000,000 And lastly, we are making good progress with our pipeline across all stages of development, including recent strong data for SKYRIZI in ulcerative colitis as well as the recent U. S. Approvals for RINVOC in Crohn's disease and Abkinley in relapsed or refractory DLBCL, both important new therapies for patients.

Speaker 1

So in summary, I'm extremely pleased with the strong momentum and execution across the business. It reinforces our confidence in our ability to return to robust growth in 2025 with high single digit compounded growth rate to the end of the decade. With that, I'll turn the call over to Rob for additional comments on our business performance. Rob?

Speaker 2

Thank you, Rick. AbbVie delivered excellent results once again this quarter. We are demonstrating strong execution across our business with each of our 5 key therapeutic areas beating expectations. We reported adjusted earnings per share of $2.91 which is $0.11 above our guidance midpoint. Total net revenues were nearly $13,900,000,000 More than $350,000,000 ahead of our guidance with the vast majority of the beat coming from our ex HUMIRA growth platform.

Speaker 2

In immunology, SKYRIZI and RINVOQ are demonstrating impressive growth with sales for both therapies up more than 50% versus the prior year. These two agents have achieved differentiated clinical profiles, including head to head data versus HUMIRA and other novel therapies. SKYRIZI and RINVOC are now collectively approved across 10 Large indications and we are forecasting combined revenue growth of more than $3,500,000,000 this year With ongoing programs in several additional disease areas, we expect both SKYRIZI and RINVO to deliver robust growth into the next decade and significantly exceed HUMIRA peak revenue. U. S.

Speaker 2

HUMIRA is also performing well with First half erosion coming in better than our expectations due to volume. We have been carefully analyzing the biosimilar marketplace, where the total number of competitors has now expanded to 8. While many of these biosimilars have been added to payer formularies, HUMIRA continues to maintain strong parity access. Based on the volume trends and parity access, We now anticipate U. S.

Speaker 2

HUMIRA erosion of approximately 35%, an improvement of 2 points versus our original guidance. Neuroscience is another area that is outperforming expectations. Based on the current run rate, this portfolio is now on pace to to add more than $1,000,000,000 of incremental revenue this year with continued strong growth from VRAYLAR as well as our leading migraine portfolio. In aesthetics, the outlook continues to improve. We delivered Positive growth this quarter, driven by strong international performance and stabilizing trends in the U.

Speaker 2

S. These positive trends give us the confidence to once again raise our full year guidance for aesthetics. And as a clear market leader, We are focused on expanding the aesthetics category with increased commercial investment and continued innovation to support robust long term growth. Given the strong and balanced performance across our diverse portfolio, we are raising our full year adjusted earnings per share guidance by In closing, our operational execution has been outstanding and we are very well positioned to deliver on our commitments in 2023 beyond. With that, I'll turn the call over to Jeff for additional comments on our commercial highlights.

Speaker 2

Jeff?

Speaker 3

Thank you, Rob. I'll start with immunology, which delivered total revenues of $6,800,000,000 exceeding our expectations. SKYRIZI continues to perform exceptionally well. Global sales were approximately 1 point Total prescription share in the U. S.

Speaker 3

Biologic market is now at 32%, double the share of the next closest biologic therapy. When you consider that SKYRIZI is capturing roughly 1 out of 2 every in play patients, which are either new to therapy or switching, There remains substantial opportunity for continued robust sales growth. And based on the available clinical data we are seeing from emerging competitive Therapies in psoriasis, including orals, we feel very confident in SKYRIZI's long term potential, with robust sales growth expected through the early part of the next decade. We are also seeing very nice prescription growth in psoriatic arthritis, especially in the U. S.

Speaker 3

Dermatology segment, where SKYRIZI is approaching the leading new patient biologic market share. Gyrizi's momentum across psoriatic disease is very solid globally as well, with total in place share leadership in nearly 30 key countries. Turning now to IBD, where SKYRIZI has demonstrated a very compelling clinical profile, including strong endoscopic data paired with convenient dosing. Uptake in Crohn's disease has been rapid With total in play patient share of approximately 25% in the U. S, roughly at parity leadership with STELARA.

Speaker 3

This uptake is very encouraging for SKYRIZI's potential in ulcerative colitis, where we recently reported positive maintenance data with approval and commercialization anticipated next year. Given the momentum we are seeing across all of the approved indications, We will be raising our full year sales outlook for SKYRIZI. Moving now to RINVOC, which delivered global Sales of $918,000,000 reflecting operational growth of nearly 57%. A key element of RINVOC's success is its strong differentiation. It is now approved across 7 distinct indications, including 4 in rheumatology, 2 in IBD as well as atopic dermatitis.

Speaker 3

It's the only potent daily oral medication with compelling head to head data against multiple novel therapies, including superiority to Humira in RA and Dupixent in AD. It's the only JAK inhibitor now approved to treat both Crohn's disease and ulcerative colitis,

Speaker 4

and we

Speaker 3

have established strong and broad commercial access for each of the core diseases, with formulary coverage for Crohn's expected to ramp quickly over the next months. As it pertains to the INVOOC performance, we are seeing increasing prescriptions across each of the room indications globally, Further market share momentum in atopic dermatitis, including now high teens in play patient share in the U. S. And robust uptake in IBD, where RINVOC has demonstrated strong rates of remission and endoscopic improvement. RINVOQ is now capturing roughly 1 out of every 4 in play ulcerative colitis patients in the second line plus setting.

Speaker 3

And the early data for Crohn's, which launched just in May, also shows a very strong ramp in new patient starts. We remained well positioned for continued momentum in this new indication as the only JAK inhibitor approved to treat Crohn's disease. This level of performance along with the development of ongoing projects across several other diseases such as giant cell arthritis in systemic lupus and rheumatology and multiple additional derm indications reinforces the long term potential for RINVOQ with strong sales growth expected through the early part of the next decade. Global HUMIRA sales were $4,000,000,000 Down 24.8 percent on an operational basis due to biosimilar competition. Erosion in the U.

Speaker 3

S. Remains slightly better than our expectations due to volume with the vast majority of the impact this quarter driven by price. Turning now to hematologic oncology, where total revenues were approaching $1,500,000,000 IMBRUVICA global revenues were $907,000,000 down 20.8%, consistent with our expectations. VENCLEXTA global sales were $571,000,000 up 15% on an operational basis with strong demand for both CLL and AML. And we are particularly pleased with the international performance here, following continued reimbursement progress in the EU and inclusion in China's national reimbursement list.

Speaker 3

We also recently received the U. S. Approval for Epkinley and 3rd line plus DLBCL, further expanding our on market portfolio in HemOnc. Early prescription trends have been encouraging with a more robust opportunity expected as we progress development in earlier lines of therapy. We also anticipate approval and commercialization in Europe and Japan later this year.

Speaker 3

In neuroscience, Revenues were nearly $1,900,000,000 up 14.2% on an operational basis. Vraylar continues to exceed our expectations. Sales of $658,000,000 were up 33.9 percent on an operational basis with Increasing momentum across all indications following the MDD approval late last year. Within migraine, We remain the clear market leader with unique treatment options for both acute and chronic conditions. Our oral CGRP portfolio contributed $292,000,000 in combined sales this quarter, reflecting growth of more than 30% as we continue to see strong prescription demand for both UBRELVI and Q Lipta.

Speaker 3

Lastly, Total BOTOX Therapeutics sales were $748,000,000 up 11.3% on an operational basis, reflecting nice momentum in chronic migraine as well as other approved indications. This franchise continues to outperform our expectations and we will be raising our full year guidance for the collective neuroscience portfolio. So overall, I'm extremely pleased with the performance and execution across the therapeutic portfolio with growth expected to accelerate through the second half of the year. And with that, I'll turn the call over to Keri for additional comments on aesthetics. Keri?

Speaker 5

Thank you, Jeff. 2nd quarter Global Aesthetics sales were approximately $1,400,000,000 up 2.9% on an operational basis, with strong performance from our international portfolio offsetting the economic impact in the U. S. 0.2%. Our U.

Speaker 5

S. Portfolio continues to perform well from a competitive perspective. And as expected, the aesthetics markets continued to be impacted by lower consumer spending related inflationary pressures, which weighed on year over year growth rates. U. S.

Speaker 5

Botox cosmetic sales were $420,000,000 a decline of 6.5% versus the prior year. While the U. S. Cosmetic toxin market declined low single digits in the 2nd quarter on a year over year basis, Growth rates improved through the quarter with June showing a return to positive year over year market growth. Botox Cosmetics continues to be the clear market leader maintaining strong and stable share despite new competitive entrants.

Speaker 5

U. S. Juvenerm sales were $125,000,000 down 14.5% a year over year basis as we continue to see a more pronounced impact from inflationary dynamics on higher priced more deferrable procedures such as filler. The U. S.

Speaker 5

Silver market declined approximately 20% in the quarter on a year over year basis due to the persistent inflationary environment. Our Juvederm collection remains the market leader and share was stable in the quarter. The economic metrics that we track for the U. S. Have largely stabilized.

Speaker 5

Our consumer market research shows a meaningful recovery from last summer and those intending to get treated with toxins and fillers. Additionally, we have now lapped the beginning of the market downturn, which occurred in the Q2 of last year. Based on these factors, we expect growth rates for the U. S. Facial injectables to improve in the second half of this year.

Speaker 5

Our International Aesthetics portfolio continues to perform exceptionally well with strong results in many key markets. 2nd quarter sales were $555,000,000 reflecting operational growth of nearly 20%. International BOTOX Cosmetics sales of 2 dollars 65,000,000 increased approximately 14% on an operational basis and international Juvenile sales were $243,000,000 up approximately 28% on an operational basis. Growth in the Asia Pacific region was particularly robust as aesthetic treatment rates in China have fully recovered to pre COVID levels. We continue to anticipate strong normalized growth through the remainder of the year in China.

Speaker 5

We are very pleased with the strong performance of our International Aesthetics portfolio over the first half of the year and continue to expect similarly strong results in the second half. In the Q3, we will be facing a challenging year over year comparison due to a shipment timing benefit we saw in the Q3 of 2022. This is expected to result in relatively flat growth for our international portfolio in the Q3. On a full year basis, We expect our international aesthetics sales to grow high single digits. We continue to invest to drive future growth for our aesthetics portfolio with a focus on enhanced promotional activities, improved digital products and services through our Ali platform, sales force expansion and injector trading.

Speaker 5

We continue to invest in our pipeline as well and we remain committed to our regular cadence of new product introductions and indication expansions for BOTOX Cosmetic and Juvederm. We recently announced the FDA approval of SKINDIV, the first hyaluronic acid filler in the U. S. For improved skin smoothness of the cheeks, which along with the recently launched Volux filler for jawline contouring will help sustain our leadership position in the U. S.

Speaker 5

Filler market. Our investments will allow us to maintain a strong leadership position in the highly underpenetrated and rapidly growing global aesthetics markets. We remain very confident in the long term outlook for our aesthetics portfolio and continue to expect to deliver greater than $9,000,000,000 in 20.29. In the near term, the improving aesthetics outlook in the U. S.

Speaker 5

And continued robust international performance gives us confidence to once again raise our full year aesthetics guidance an expectation for continued operational growth over the back half of the year. With that, I'll turn the call over to Tom.

Speaker 6

Thank you, Carrie. We've continued to make very good progress with our pipeline over the quarter. We had a substantial amount of activity across Our R and D pipeline is resulting in new approvals and advancements of several programs. In immunology, we received FDA approval for rainbow can Crohn's disease, marking its 7th FDA approval across gastroenterology, rheumatology and dermatology. In our Crohn's development program, RINVOC demonstrated a very rapid and strong impact on symptoms as well as endoscopic improvement.

Speaker 6

Given its strong benefit risk profile, we believe RINVOC will be an important new medicine for patients suffering from moderate to severe Crohn's disease. While Crohn's disease approval marks the completion of the core indications, we believe RINVOC has the potential to become a highly effective therapy in several additional important diseases. We recently began Phase III studies for RINVOC in systemic lupus and hidradenitis suppurativa and we remain on track to begin Phase 3 studies in alopecia areata later this year. We'll also see data later this year from a Phase 2 study in vitiligo, which could to support advancement to Phase 3 in this indication as well. Moving to SKYRIZI, where in the quarter we announced positive top line results from our Phase 3 maintenance trial in ulcerative colitis.

Speaker 6

In this study, SKYRIZI met the primary and key secondary endpoints at week 52 compared to the withdrawal arm, demonstrating that patients continuing treatment with SKYRIZI maintain high levels of clinical remission as well as more stringent endpoints such as endoscopic improvement, histologic endoscopic mucosal improvement and steroid free remission. It's important to know that approximately 75% of the patients in this study had failed advanced therapy, including not only anti TNFs, but also other biologics, JAK inhibitors and S1P modulators. This represents a very difficult to treat population in ulcerative colitis. SKYRIZI's strong performance in patients with and without failure to advanced therapies, including patients who were naive to advanced therapy, demonstrate its utility across the spectrum of moderate to severe UC patients. We remain on track to submit our regulatory applications in the Q3 with approvals anticipated in 2024.

Speaker 6

We also recently published results from a head to head trial comparing SKYRIZI to OTEZLA in patients with moderate psoriasis with SKOVAZY demonstrating clear superiority to OTEZLA on all primary and ranked secondary endpoints at week 1652. At week 52 of this study, 64% of patients achieved Absolute Skin Clearance as measured by PASI 100 and SPGA Clear compared to just 3% for Otezla, underscoring SKYRIZI's ability to drive very high and durable responses in these moderate patients. In addition to higher clinical efficacy outcomes, the patients treated with SKYRIZI, which is a self injectable administered quarterly, reported improvements in health related quality of life measures and greater treatment satisfaction compared to those 3 with Otezla, which is an oral administered twice daily. Additionally, SKYRIZI demonstrated favorable safety and tolerability compared to OTEZLA. The rates of adverse events, including serious and severe AEs We're numerically higher with OTEZLA than with SKYRESI treatment.

Speaker 6

Previous to similar to previous studies, Otezla treatment was associated with high rates of gastrointestinal distress such as nausea, diarrhea and vomiting, which resulted in a 7% discontinuation rate in the 1st 16 weeks of treatment compared to No discontinuations for SKYRIZI patients. We're incredibly pleased with these results, which further underscore SKYRIZI's position as a best in category treatment for moderate to severe psoriasis, providing very high efficacy, durable responses, a safe and tolerable profile and convenient quarterly administration. In oncology, we received accelerated approval in the U. S. For AKINLY as a monotherapy treatment for patients with relapsed or refractory DLBCL, who had received 2 or more systemic therapies.

Speaker 6

We also recently received positive CHMP Opinion with an approval decision in Europe expected later this year. DLBCL is a very aggressive disease where later line patients have limited options. We're extremely excited to bring this new subcutaneous treatment option to patients. In the quarter, we also announced Positive top line results from the follicular lymphoma cohort of a Phase 2 trial evaluating at Kinley in patients who have received at least 2 prior lines of therapy. In this study, AKINLE performed very well as a monotherapy, demonstrating an overall response rate of 82%.

Speaker 6

We are pleased with these results and plan to discuss these data with regulatory agencies about the potential to support a submission for accelerated approval. Beyond the mid stage studies Supporting accelerated approvals in later lines of therapy. We also have Phase III trials ongoing in earlier lines of DLBCL and follicular lymphoma, and we look forward to providing updates on these programs as the data mature. In our nebuloclax program, we recently saw top line results from the Phase III TRANSFORM-1 trial evaluating nevideclax in combination with ruxolitinib for patients with treatment naive myelofibrosis. The study met the primary endpoint at week 24, demonstrating a statistically significant improvement in the percentage of patients who achieved spleen volume reduction of at least 35% compared to rux plus placebo.

Speaker 6

For the primary endpoint, the nevedoclax combination showed a doubling of improvement over rux alone with 63% of patients on the nevitoclax combination achieving SVR35 compared to 32% in the rux plus placebo combination. In this study, the nebuliclast combination did not achieve the 1st rank secondary endpoint, which was improvement in total symptom score at week 24. Additional follow-up data on SVR and TSS as well as other endpoints are expected in the Q4 of this year. We plan to wait for these more mature data before engaging with regulatory agencies in order to have a more comprehensive picture of the patient's clinical response and clinical benefit that nebuloclast can provide. Looking to the remainder of this year, we remain on track for several additional data readouts from our late stage oncology programs, including Phase 3 data from VENCLEXTA's Canova trial in relapsedrefractory multiple myeloma patients with T1114 mutation.

Speaker 6

As a reminder, this is an event driven study and we're just waiting we're waiting for just a handful of remaining events. So we'd expect to have these data in house in the coming months. And we remain on track to see Phase 2 data for teleservi in 2nd line plus advanced non squamous non small cell lung cancer in the Q4. We're also making very good progress with several earlier stage solid tumor programs. We recently initiated a Phase 2 study for ABBV-one hundred and fifty one, our anti GARP antibody in hepatocellular carcinoma and plan to begin Phase 2 in several additional solid tumors over the course of the next 12 months.

Speaker 6

At the recent ASCO meeting, we presented promising initial results from a Phase 1 study evaluating our next generation c Met ADC, ABBB400 in several advanced Solid tumor types. We're seeing responses across multiple tumors indicating broad activity. Results in late line colorectal patients were encouraging where monotherapy treatment with 400 resulted in a confirmed overall response rate of 22%, well in excess of standard of care, which is typically less than 2% to 3%. We're also encouraged by the durability of response seen in these early results. These patients had an average of 5 prior lines of therapy.

Speaker 6

So this level of efficacy is very encouraging. Based on these results, we plan to start our Phase 2 program later this year, beginning with a second line colorectal cancer study. Now moving to neuroscience, where in the quarter we received a positive CHMP opinion recommending approval of etorgepant for migraine prevention. We anticipate a decision in the coming months and if approved, etogepat would be the only oral CGRP antagonist approved in Europe for prevention of both episodic and chronic migraine. This is a debilitating condition that impacts Tens of millions of people in Europe, and we look forward to making this new oral treatment option available to patients once approved.

Speaker 6

Also in the area of neuroscience, ABBB-nine sixteen, our A beta antibody for Alzheimer's disease is rapidly advancing through dose escalation studies. This antibody is demonstrating a long half life and very low antidrug antibodies, both important attributes to achieve a best in class profile for our A beta antibody. Dose selection in Phase 2 is expected to begin early next year. And lastly, in our aesthetics pipeline, we recently submitted our regulatory application for BOTOX in masseter muscle prominence in China, which is the initial focus for our program given the prevalence of masseter muscle prominence in Asian populations and a significant unmet need for minimally invasive treatment options. In our platysma prominence program for BOTOX, we remain on track to see data from 2 additional Phase III studies later this year with our regulatory submission in the U.

Speaker 6

S. Expected near the end of the year. So in summary, we had a very productive first half of the year across all stages and therapeutic areas of our pipeline and we look forward to the second half of twenty twenty three with several important clinical and regulatory milestones. With that, I'll turn the call over to Scott.

Speaker 7

Thank you, Tom. I'm very pleased with the performance and outlook of the business, including the strong momentum from our ex HUMIRA growth platform. Starting with our Q2 results, we reported adjusted earnings per share of $2.91 which is $0.11 above our guidance midpoint. These results include a $0.15 unfavorable impact from acquired IP R and Expense. Total net revenues were nearly $13,900,000,000 more than $350,000,000 ahead of our guidance and down 4.2% on an operational basis, excluding a 0.7% unfavorable impact from foreign exchange.

Speaker 7

Importantly, these results reflect high single digit sales growth from our growth platform. The adjusted operating margin ratio was 47% of sales. This includes adjusted gross margin of 84.7% of sales, adjusted R and D investment of 12.5 percent of sales acquired IP R and D expense of 2% of sales and adjusted SG and A expense of 23.2 percent of sales. Net interest expense was $454,000,000 The adjusted tax rate was 15.8%. Turning to our financial outlook, We are raising the midpoint of our full year adjusted earnings per share guidance by $0.23 and now expect adjusted earnings per share between $10.90 $11.10 This guidance does not include an estimate for acquired IP R and D expense that may be incurred beyond the Q2.

Speaker 7

We now expect total net revenues of approximately $53,400,000,000 an increase of $1,000,000,000 At current rates, we expect foreign exchange to have a modest unfavorable impact on full year sales growth. This guidance includes the following updated assumptions with more than half of the sales improvement attributed to our ex HUMIRA growth platform. We now expect SKYRIZI global sales of approximately $7,600,000,000 an increase of $200,000,000 due to continued strong performance across all approved indications. We now expect neuroscience sales of approximately $7,700,000,000 an increase of $300,000,000 Reflecting robust prescription growth for VRAYLAR following the MDD approval as well as better than expected performance of BOTOX Therapeutics and Culipta. And for Aesthetics, we now expect global revenue of approximately $5,400,000,000 an increase of $100,000,000 primarily reflecting momentum from BOTOX Cosmetic.

Speaker 7

Lastly, we now anticipate U. S. HUMIRA erosion of approximately 35%, resulting in a sales guidance increase of $400,000,000 based on volume trends and strong parity access. Moving to the P and L, we continue to anticipate adjusted gross margin of 84 percent of sales and now expect adjusted R and D expense of $6,900,000,000 SG and A expense of $12,700,000,000 and an adjusted operating margin ratio of approximately 46.5 percent of sales. Turning to the Q3, we anticipate net revenues of approximately $13,700,000,000 which includes U.

Speaker 7

S. HUMIRA erosion of approximately 40%. At current rates, we expect foreign exchange to have a modest unfavorable impact on sales growth. We expect adjusted earnings per share between $2.80 $2.90 This guidance does not include acquired IP R and D expense that may be incurred in the quarter. In closing, AbbVie has once again delivered strong and Bottomline performance.

Speaker 7

And we are very pleased with the momentum of the business heading into the second half of the year. With that, I'll turn the call back over to Liz.

Operator

Thanks, Scott. We will now open the call for questions. In the interest of hearing from as many analysts as possible over the remainder of the call, we ask that you please limit your questions to 1 or 2. Operator, we'll take the first question please.

Speaker 8

Vamil Daman, Guggenheim Securities.

Speaker 4

Hi, Rick. Thanks for taking my questions. So one, I'm just curious given the strong quarter and the guidance raise. In terms of you talked about your Floor EPS, is that do you still see a floor of $10.70 or is it different? And can you Talk anymore at this point or when you see that flow happening?

Speaker 4

And then my second question was just around IRA and obviously a lot of focus there. I'm curious if you have any thoughts around, look at the first list of products around September 1. Do you expect any AbbVie products to be Included in that first group of 10. And then I'm curious just on Renvoke specifically and how you see them might be at risk from IRA given doing obviously a lot of life cycle development there. And is there a chance that a life cycle may not be quite as long, but then how you're you're thinking about prioritizing investing behind a small molecule like rainbow?

Speaker 4

Thank you.

Speaker 1

Vamil, this is Rick. I'll take the first Question and maybe Rob and I can also tag team on the first one and the second one as well.

Speaker 6

So So if

Speaker 1

you look at the floor, if you step back and look at how the business is performing, obviously, the business is performing extremely well. And A significant part of the overachievement is not the HUMIRA business. In fact, of the $1,400,000,000 we're raising, As Scott said, only $400,000,000 of it is HUMIRA, so $1,000,000,000 of it is the growth platform.

Speaker 6

So all that speaks

Speaker 1

that we're going to we have very strong momentum going into 2024. And we've talked before on these calls about, well, when will trough year occur? And as you think about the floor, I think you have to sort of think about the trough here at the same time. We said in the past that If we significantly overachieved in 2023, that would increase the probability that the trough year was in 2024. And we said that in the backdrop of primarily thinking about it as HUMIRA overachieving.

Speaker 1

And obviously now what we're seeing It's the majority of the other products that are overachieving the growth platform. So as we look at 2024 and as we look at the trough, I think we have to let the year play out a little bit further to see where we're going. But I would say that, we're feeling pretty we're feeling very good about 2024 And the growth of that non HUMIRA business could more than offset the over performance that we're seeing this Especially the over performance that we're seeing on HUMIRA. So it's too early to raise the floor. But what I would tell you is the performance that we're seeing now gives us a tremendous amount of confidence of what 2024 looks like.

Speaker 1

Robin, you'd add?

Speaker 2

I'd just add that we've now collectively raised revenue guidance by $1,400,000,000 As Rick mentioned, we raised it $400,000,000 Quarter $1,000,000,000 this quarter. When you look at it, it's really across the key therapeutic areas that will drive long term growth. We've raised Skyrizi, Aesthetics, Neuroscience and also HUMIRA. So we do feel very good about the performance of the business. We debated when we update the floor that will come at some point, may not come until we actually give the Q4 guidance On the Q4 call of 2024 guidance, but as we look at it, the fundamentals of this are very, very strong and we're seeing performance across all of therapeutic areas.

Speaker 1

On your second question, IRA, I think it's very difficult to predict. In our planning assumptions, we have assumed for some products to be impacted here early on. IMBRUVICA is obviously one product that we're looking at carefully. I would say it's right from how we would calculate it Based on the data that we would have, it would be right on the bubble of where the cutoff would occur In those first ten products. So it could be 10, could be 9, could be 11, depending upon how some other products.

Speaker 1

And I say it That way because remember, we're using the data that we have. We're not 100% sure that that is the data that CMS is going to use. So there's not perfect clarity around it. But I would say that's one that we obviously have on the radar screen and we're looking at carefully. Anything you'd add Rob?

Speaker 1

When IRA was passed

Speaker 2

a year ago, we obviously modeled the impact and we reaffirmed the long term guidance Took a high single digit growth in the second half of this decade. That remains. We looked at what it means in terms of inflation penalties, party benefit redesign negotiations. So we did make assumptions around that. I think Rick is correct in that.

Speaker 2

There is still enough uncertainty. We're going to know soon, right? September 1 is when they expect to announce the first list. We have modeled it, but we feel good even with IRA, although it does have an impact, it has an impact on everyone in the industry, we can still deliver on our long term growth expectations. On your question and then keep in mind too, when you look at the Medicare percent of business for AbbVie, in the U.

Speaker 2

S. It's about 20%. Globally, it's a little bit lower obviously. And so you look at us relative to our peers, we have a lower percent of the business as exposed to Medicare. And then when we look at specifically at RINVOC, the thing you have to keep in mind with RINVOC, with indication expansion, the percent of sales you're talking about by the time Potentially, we selected for negotiation, potentially in the later part of the decade.

Speaker 2

You're talking about somewhere like 10% to 12%, because you have to keep in mind the new indications In many cases serve younger patient populations. And so that's the way we're looking at Renvoca. We're continuing to develop it. We obviously have a number of indications that could launch Later in the decade, we feel very good about that. Those indications can collectively contribute a couple of $1,000,000,000 of revenue.

Speaker 2

We'll continue to drive that robust growth we expect RINVOK and SKYRIZI as well. And so, we've modeled the impact of IRA. We don't expect it to impact the development plans for RINVOK.

Operator

Thank you, Vamil. Operator, next question please.

Speaker 8

Chris Schott, JPMorgan.

Speaker 9

Great. Thanks so much. Just two questions for me. I guess first, can you just elaborate in terms of what you're seeing with biosimilar HUMIRA as we think about kind of the price And volume dynamics. I guess specifically, any surprises from your side in terms of how this is playing out?

Speaker 9

And then just any qualitative Comments you can provide about how you see this kind of translating as we kind of think out to 2024? And then my second question was just on the SKYRIZI updated guidance. Just a little bit more color on that $7,600,000,000 at this point, how much is coming from psoriasis versus psoriatic arthritis versus This Crohn's launch, it seems to be off to such a strong start. So just directional color of like the mix of the indications would be very helpful. Thank you.

Speaker 3

Yes. Hi, Chris. It's Jeff. And I'll answer your first question. So in a nutshell, we haven't been surprised At any of the dynamics that we've seen play out, we've called it very, very accurately.

Speaker 3

So again, nothing that's really Other than some small volume holding on a little bit better, that's really different. So we're quite pleased with how our contracting and And that parity access for HUMIRA has been important. And again, it's what we believe would happen. We think it's good for patients, obviously, who can maintain their therapy with very little volatility and it certainly provided us with a lot of predictability. And so I think we've managed sort of the first half with the Amgen launch and then the second half dynamics very, very well.

Speaker 3

And And if you look to 2024, as I've highlighted before, we do have 2 year agreements with some of our accounts. And we negotiated those in good faith and we expect them to be honored. And remember, these are parity contracts for both 2023 2024 with HUMIRA Access coexisting with these multiple biosimilars. So I would say based on these dynamics, we're confident that HUMIRA access will remain quite meaningful in 2024. And, we know that as more biosimilars become established, We're also, as we've highlighted, appropriately planning for, some volume loss in those certain so called WACC sensitive accounts over time.

Speaker 3

So Really no surprises in terms of what we've seen overall. So we're quite pleased.

Speaker 2

Chris, this is Rob. Just give you some color both in terms of the 2023 guidance and the assumptions around that and then I'll talk about 24 briefly as well. In the first half of the year, obviously, the vast majority of that erosion came from price. We saw very little volume impact. But now with 8 Biosimilars on the market and some pursuing a low WACC strategy.

Speaker 2

We have assumed high single digit volume erosion in the second half of the year, which would put the full year volume impact at mid single digits. The rest of the 35% comes from price as we've negotiated those higher rebates to maintain strong parity access. Now while we're not providing 24 guidance today for U. S. Chimera, it is reasonable to assume that there will be additional price erosion.

Speaker 2

Some will come from the annualization of the rebates that increased in the second half of this year and some will come from rebate increases negotiated for I'd also expect more volume erosion in 2024 given the midyear entry of biosimilars this year, especially those that are pursuing a low WACC Strategy. We've taken a close look at consensus estimates. Analyst estimates have a very wide range. The difference between the lowest estimate and the highest estimate Just $4,000,000,000 However, I'd say the average of those estimates appears to be a reasonable expectation for next year. Obviously, we'll give Formal guidance, likely on the Q4 call, which is our customary practice.

Speaker 2

But if you look at the average of those estimates, it should give you a good sense.

Operator

Thanks, Chris. Operator?

Speaker 1

No, I got numbers here.

Speaker 2

Sorry. Yes. And then I'll take this is Raul. I'll take your question on SKYRIZI. So of the $200,000,000 it's Split evenly between psoriatic $100,000,000 and IBD $100,000,000 that's $7,600,000,000 psoriatic is about $6,700,000,000 and IBD is around 900,000,000

Operator

Thanks, Chris. Operator, next question please.

Speaker 8

Mohit Bansal, Wells Fargo.

Speaker 10

Great. Thank you very much for taking my question and congrats on the quarter. One clarification question and then one question. So clarification, so Rick, you mentioned that You think like again, at this point, you're not talking about increasing the floor, but you feel comfortable about Floor EPS range of $10.70 Is that fair, be it 2023 or 2024? That's the first clarification question.

Speaker 10

And then second one is, When we talk to investors, they do feel comfortable about the ex HUMIRA portfolio. But one question that Comes up all the time is that, I mean, the lack of shiny object or pipeline beyond Skyresien Brinvo. To the extent you agree with that assessment, how do you plan to mitigate that? Or is there anything in the pipeline that I'm missing at this point. Thank you.

Speaker 1

Okay. This is Rick. So as far as the 10.70, I would tell you that we feel highly confident in the 10.70. So, there shouldn't be any concern there. And as I said, with How the growth platform is performing, we would expect to update at some point the floor and Obviously, by the way, I'm saying it, the update would be in an upward direction.

Speaker 1

So hopefully that gives some clarity around the floor. When you think about the pipeline, what I tell you about the way we operate is we design our investment in R and D to be able to deliver the kind of growth that we expect for the business over the long term, both short term and long term. Our expectations of the business haven't changed. Our expectations are to build a strategy that allows this business to grow at the top tier and be able to do it over the long term and do it in a consistent way. And I'd say, as I look at our historical performance, we've obviously delivered on that.

Speaker 1

But as I look at forward looking performance through the end of this decade and into the early part of the 30s, we're highly confident we can deliver high single digit growth With the pipeline that we have now and ultimately with the assets that we have in the marketplace and how they're performing in the marketplace and their ability To be able to drive significant growth and you see that in the performance that we're delivering now. If you look at that growth platform's growth in 1st quarter And then look at in Q2, it's accelerating at a very good pace and it will continue to accelerate as we go through the rest of this year. And that once we get to a stable tail or relatively stable tail on HUMIRA, it will be that growth that emerges to be able to drive the company That's what gives us such a high level of confidence. But I think when you look at our pipeline, certainly we invested significantly in Kyrizi and RINVOG and that investment is paying off extremely well. We have a number of assets in our pipeline That will continue to help accelerate that growth as we move forward.

Speaker 1

So venetoclax for T1114 and MDS are examples of that 951, we should do that resubmission and get that product on the marketplace. There's a huge need for that product in the marketplace and a number of other assets, I won't go through every one of them. The rest of our investment in R and D has really been focusing on assets That are designed to be able to sustain our growth from 2,030, 40 forward. And so As I look at our pipeline, and I know you don't have as much visibility as we do, but when I look at our pipeline for things like the 400 platform And the c Met platform that we have. The data we're seeing in CRC on small cell, that's a significant opportunity for Mark is another significant opportunity for us.

Speaker 1

Our neuroscience portfolio of 916 and other assets Is another significant opportunity for us that will emerge in that timeframe. We have a next generation BTK Degrader That we're excited about. We have a 2nd generation BCL-two that we're very interested in pursuing in multiple myeloma. And so there's a number of assets here that just haven't emerged to the point that you have clear visibility to all that data, but we do have visibility To where they're progressing. And so I think it's just hard for you to assess that earlier pipeline, but it's really designed to deliver on that long Term growth.

Speaker 1

So we're confident between now and the early 30s. And as that pipeline matures and the data comes out, 383 is another good example of where we have a lot of data now that is demonstrating that is probably best in class Right, bispecific in myeloma. And so as that data emerges, you're going to get more visibility to it. And then obviously, we have the ability to go out and acquire things and find things that we're interested in.

Operator

Okay. Thank you, Mohit. Operator, next question please.

Speaker 8

Terence Flynn, Morgan Stanley.

Speaker 11

Hi, thanks so much for taking the questions. Maybe a couple for me. Maybe Rick, just to follow-up on that last Comment maybe just an update on your M and A BD appetite here, particularly assets that can contribute more near term to growth. And then again, want to see what you guys are hearing out there regarding the long acting BOTOX competitor. Sounds like you're seeing stable market share, but any feedback on that product?

Speaker 11

Thank you.

Speaker 1

Okay. So M and A, I mean, obviously, we have a very active group who's constantly working in the area of Business Development. We're primarily focused in the areas that we operate in franchises. So think of things like immunology, Neuroscience, certain areas of neuroscience, oncology, aesthetics as an example, We constantly look at and then eye care will be, I would say, the key areas of focus. As I said before, we don't need anything to be able to drive that high single digits.

Speaker 1

Obviously, if we can grow even faster, that's a good thing. I think all of us recognize that. If we find assets that are out there that are later stage assets and they fit our strategy and they fit The kind of target product profile that we would expect, because we only look for assets that can significantly change standard of care. That's what we're good at. And so we evaluate lots of things, but many of them don't meet that threshold that we're looking for.

Speaker 1

But if we find something, we would obviously pursue it. If it was in an area that we thought we could maximize the value of it. And so, we'll continue to do that. So like I said, I feel good about where we are and what we can drive. And I feel good about

Speaker 12

how we're looking at assets that are in the outside.

Speaker 1

We certainly have the financial wherewithal That's there in the outside. We certainly have the financial wherewithal to be able to acquire assets that are out there. And as we've mentioned before, we obviously acquire now larger assets and so we continue to look at those. But they have to meet our criteria

Speaker 4

and they have

Speaker 1

to be able to deliver A good return to the business. On DAXI, I feel very good about how the team, Carey and the team are performing Again, Daxi, but I'll let Carey actually describe to you how it looks.

Speaker 5

Thanks, Rick. So in terms of Daxi, it's been more than 6 months since their launch. And the uptake has been quite limited from our perspective in the low single digits. So for context, as we benchmark our competitive launches and you would benchmark this launch versus the most recent toxin to enter the U. S.

Speaker 5

Market. You would see it's tracking to about 25% of where another product would be at same point in its launch. And in terms of customer feedback, we continue to hear that expectations are just not being met on duration. That's expectations on the customer side and on the consumer side. So we have yet to see impact on BOTOX share and BOTOX will continue to be the clear market leader as the other toxins compete for the number 2, 3, 4 position in our customers' offices.

Speaker 5

We are very pleased with the team's ability to execute on these competitive strategies here. And actually their clear focus not only on the competitive strategies, but also on the broader focus and vision to grow the entire toxin market in the U. S, which we continue to see as the biggest opportunity now and in the future.

Operator

Thank you, Terrence. Operator, next question please.

Speaker 8

Evan Sigerman, BMO.

Speaker 12

Hey, guys. Sorry about that. I was on mute. Thank you for taking my question. I wanted to just talk about kind of how you think about market share Across the growth portfolio, specifically SKYRIZI and RINVOC kind of going forward, is there a potential ceiling for them on a market share you can realize in these markets?

Speaker 12

Maybe comment on some of the gating factors for market share growth in each, left to patient, provider and reimbursement agreements. Thank you so much.

Speaker 3

Yes. Hi, Evan, it's Jeff. I'll take that one. One of the aspects that we have that I highlight and we look very carefully at, we look at both Sort of in play capture, which I often refer to, for example, right now the in play capture for SKYRIZIAN psoriasis is about 50%. So we're capturing 1 out of every 2 patients.

Speaker 3

And our market share is about 32 As I highlighted. So theoretically, as we study these markets that if there's not major innovation or major disruption that comes In place, and we really don't see that in psoriasis. You get such a high level of efficacy with SKYRIZI. Your market So the 32% starts to ramp up over time towards your in play capture because you get the persistency effects and the fall offs that take place in the market. So Really when you look at that, I could say the same thing for example with, RINVOC.

Speaker 3

I mentioned that it's capturing 25% of second line plus in play share. It has like a 3% market share. So in terms of the ability to sort of grow that market share over time, we really monitor that Capture rate in the early years and then you just sort of the in place sort of pulls up your market share over time. So that's why we're quite encouraged At the speed of the ramps that we're seeing there and the ability to move that market share. Now when we study the models, you don't Fully get there because typically something else launches, time goes by.

Speaker 3

But we can feel very, very encouraged As we look at our in play momentum that the market share starts to approach that over our long range planning cycle.

Speaker 1

The only other thing I would add, this is Rick, With this OTEZLA head to head, I would say currently SKYRIZI is not competing much against OTEZLA, which is a pretty sizable opportunity. And with it, we're very pleased with this head to head data. So that will open up another pool of patients that today SKYRIZI doesn't necessarily Compete against, so that data will obviously allow us to be able to position it quite effectively against Otezlon.

Operator

All right. Thank you, Evan. Operator, next question please.

Speaker 8

Chris Raymond, Piper Sandler.

Speaker 13

Thanks. Just maybe a pipeline line of questioning here. Rick, I heard you mentioned DB-nine fifty one, but it wasn't in your prepared comments. Maybe I know you guys were saying you're working to respond to the CRL later this year with a PDUFA in the first half. Is that still the case?

Speaker 13

And then maybe also on the pipeline, a couple of quarters ago, I think you guys talked about an interest Combo opportunity in IBD with that GLP-two UN license, I think from Scripps. Any updated thoughts here with this Sort of mechanism as a combo agent. Thanks.

Speaker 2

Hi, it's Rupal. I can Take those. So for 951, the team is still on track for a resubmission this year consistent with what you just stated. And in fact, we've launched in Japan and there's already Commercial patients receiving it. So the team is very excited about that.

Speaker 2

And what was described earlier, the unmet need is still Quite high and we still believe in a very strong profile in that asset. Along the lines of combinations, as you mentioned, on GLP-two, we feel with something like SKYRIZI, The data that we've seen in Crohn's and ulcerative colitis, there's still potentially an opportunity to even increase Endoscopic or mucosal healing even higher. We're seeing high ranges already 50%, 60%, But we can still potentially go higher and something like a GLP-two can directly address mucosal healing. So that could be a potential combo. There's other assets in our immunology pipeline that we are also considering for combination.

Speaker 2

But when you have an asset like SKYRIZI and the safety profile that we continue to observe, that creates, I would say multiple opportunities.

Speaker 6

If I can just add, we didn't really opt in yet. Our collaboration with Caliber, which we Expanded this week to more programs, includes them doing a Phase 1a study, which is almost finished. We're going to see the data and make that decision. It does fall into our part of our immunology program, which is epithelial repair, which Rupal just mentioned. And so this is one of the assets, which we think if you get a Healthier Gut to repair that there will be in combination with immunomodulators and get a better response over time.

Speaker 6

We have another program called Rip K1, which also is involved in epithelial repair. So there's multiple strategies, but this is one where we'll be making a decision and announcing at a later time this year.

Operator

Thank you, Chris. Operator, next question please.

Speaker 8

Steve Scala, TD Cowen.

Speaker 1

Thank you. A couple of questions. This morning Takeda noted weakness in the U. S. GI market and it seemed to be mainly on patient levels as opposed to Competition.

Speaker 1

Wondering if you're seeing this and to what do you attribute it? So that's the first question. On the second question, on the Q1 call, the company Said it would narrow the EPS range when it had clarity on biosimilar Humira and the landscape for that. So you narrowed that range today despite most biosimilars having been on the market for only 3 weeks. What do you know now that you didn't know when you reported in April that gives you the confidence to narrow the range today?

Speaker 1

Or is it all about the performance of the rest of the portfolio and really not about HUMIRA? Thank you.

Speaker 3

Yes. Hi, Steve, it's Jeff. Now we don't see any slowdown in the IBD market. I mean this market has been just One of the highest growth markets we've seen from a CAGR perspective over many, many years. There's such unmet need.

Speaker 3

And so no, we're not seeing any patient slowdown. I would say, look, if we look at our particular data, I mean, you're seeing very fast ramps On this in place share from SKYRIZI and Crohn's disease, now you're seeing an equally fast ramp in the early weeks From RINVOC and Crohn's disease. And again, we're capturing up to 25% of the second line plus patients in ulcerative colitis. So I don't know what data Takeda is looking at, but we're seeing that the competitors in that space and the leading competitors are STELARA and Entyvio and of course our own HUMIRA, but it's STELAR and Entyvio. They're under pressure in terms of incremental patient capture since our launch And we'll continue to monitor.

Speaker 3

But we don't see any patient flow issues in the marketplace.

Speaker 2

And Steve, this is Rob. On your second question, I think it's a combination of both. We're seeing very strong performance from the ex HUMIRA growth platform as you can see by the guidance raised. So that's certainly a contributor. But now that we're Beyond the middle of the year, we know the bioswares that have entered the market, we know they're facing prices.

Speaker 2

We've maintained strong parity access. And so that also increased our confidence, Which is why we've narrowed the range to $0.20 But it's a combination of both the ex HUMIRA growth platform performing very strongly As well as where we sit today with biosimilar competition for HUMIRA.

Operator

Thanks, Steve. Operator, next question please.

Speaker 8

Carter Gould, Barclays.

Speaker 14

Thank you for the questions. Congrats on the quarter. I guess, 2, acknowledging all your comments on the pipeline and previous comments on BD, Rick, I was looking to get your thoughts on how the more assertive FTC here is either limiting your target list on BD or your ability to complete deals. And then maybe just on BOTOX, just I was hoping for a little bit more color on the sustainability of the ex U. S.

Speaker 14

Trends versus Maybe some of that demand getting pushed into the quarter after some of the shutdowns, COVID impacts and whatnot ex U. S? Thank you.

Speaker 1

Yes. So I'll take the first question. Obviously, the FTC appears to be applying a lot more scrutiny to transaction. Having said that, I would say even before this happened, we would always evaluate An acquisition of a product or a company in the backdrop of what we thought the competitive environment would be Our position in that market, meaning we didn't necessarily go out and try to do transactions that we thought would be extremely difficult from an FTC standpoint. So I think the way we think about the FTC situation now is, look, it may require more time To get acquisitions through.

Speaker 1

It may even require that you're willing to pursue litigation in order to get those through. But in the end, if your position is that what you're trying to do It is not anti competitive, you will be able to ultimately prevail in that process. And I think we're seeing that as Some of these transactions go to court, some not in our own industry, but in other industries. I think that's playing out. And so, I think ultimately it will end up being more of a delay, but not Something that stifles your ability to do things that are appropriate to do.

Speaker 1

That's my perspective on it. Carrie?

Speaker 5

Sure. In terms of the aesthetics market internationally, like we said, we've been very pleased with the performance so far and we expect to we continue to expect to see that type strong performance for the rest of the year. We're continuing to invest in key growth markets like Japan and in markets like Brazil and of course China has become our 2nd biggest market globally. And in China in the Q1, we did see Growth as the market was reopening from COVID and some pent up demand that came through in Q1 and early Q2. And now China has returned to normalized high growth rates.

Speaker 5

And so despite some economic pressures there, we really continue to see strong growth as we continue to invest And expand our promotional footprint there through field force, through injector training and our consumer efforts. And China will continue to be a really attractive market For us, based on that commercial expansion and also we're going to have a steady flow of new product launches throughout the decade in that market. One thing to note, which we did mention in our prepared remarks is that we do expect Q3 to be relatively flat internationally based on shipment from last year, with that return to growth in Q4 and high single digit growth for the full year internationally.

Speaker 2

And then Carter, you were specifically asking about international BOTOX, I think if you just look at the run rate through the 6 months of the year, that's probably a good proxy for where we expect International BOTOX to land. It's We're holding strong share positions. Performance is very, very good. So there's really no dynamic there, as Carey mentioned. I mean, you have to keep in mind that filler is a very large market for us, business for us internationally.

Speaker 2

We do have the Q3 dynamic. But when you look at the full year for international, that high single digit growth is certainly a way to think about the international business for aesthetics.

Operator

Thanks, Carter. Operator, next question please.

Speaker 8

David Risinger, Leerink Partners.

Speaker 15

Yes, thanks very much. So I have two questions. Rick, you had mentioned that you're expecting Stabilization of HUMIRA sales at some point. Could you provide some perspective on when you might And then second, with respect to the filler franchise, obviously, it's Performing strongly, could you discuss the prospects including the driver of weight loss drug patients Seeking to compensate for facial hollowing. Thank you very much.

Speaker 1

On the HUMIRA Hale, as Rob mentioned earlier, obviously, you have the annualization of the impact that we have this year, the second half annualization It's going to roll into 2024. We're going to have further price erosion in 2024, both based on the contracts that we have and How we're expecting the market to play out. And I'd say the pricing in the marketplace has been consistent with what our original assumptions were. So I think the expectation was you'll start to see stabilization of that tail in 2025. And And if it operates similar to what we see in the international markets, which I think it probably will at that point, it becomes relatively stable, I'd Say in 26 going forward.

Speaker 1

And it should be still a substantial tail That we maintain, but we'll see less erosion pressure on it at that point. Carrie, you want to talk a little bit about the OTEZLA impact?

Speaker 5

Sure. So, in terms of the filler opportunity and outlook, I guess Ozempic. I'll start, I'll zoom out a little bit and just comment on that. The filler market continues to be really attractive, especially internationally as you've As you've already seen here right now with China driving some strong growth and really some of the key Juvederm brands have Just become available in China in the past few years and will continue to have, like I said, a cadence of deuterium launches in China. And then our increased investment all over the world and continues to drive our filler business and gives us a lot of optimism there internationally.

Speaker 5

Now in the U. S, we have said that the inflationary dynamics have impacted the U. S. Market For filler, and more than toxin, just by the nature of the filler pricing and procedure and also in terms of the patient journey, Patients tend to start on toxin before they add filler. And so for all those reasons, we believe that The top filler market will continue to improve in the second half of the year, although it will lag the toxin market Kaveriabet.

Speaker 5

Now in terms of the question around Ozempic, we have been keeping an eye on that and how these weight loss products could have an impact on the aesthetics market. And what we see is that really anything that gets a consumer engaged in their appearance, including products like Ozempic, are a positive tailwind for the aesthetics business. And we are hearing some customers, Say that this facial hollowing for fillers is or for that's a result of these products is an opportunity for fillers. We see that on social media, we're tracking it in other forms of media. And we think that Like many other consumer trends around aesthetics, this will just continue to be a tailwind and a positive dynamic for the business.

Operator

Operator thanks, David Risinger. Operator, next question please.

Speaker 8

Tim Anderson, Wolfe Research.

Speaker 2

Thank you. A couple of questions. How much uncertainty is there in terms of contracting in the I and I category in 2024 from A pricing standpoint, for SKYRIZI and RINVOGUE. And when will you be able to provide an update on how those Pricing discussions are going for those 2 brands. So not the formal sales guidance for those products, but how the pricing discussions are going.

Speaker 2

And what is your expectation today for that level of price erosion in 2024 relative to what it's been in 2023? Thank you.

Speaker 1

Okay. So I think Jeff and I will tag team this one. It's a great question because look, We all know there has been some question out in the marketplace since the Q1 about I and I pricing. So let me try to frame our perspective on the pricing, because I think there's some misconception That's developed in the marketplace to some extent around I and I pricing. I guess the first thing I'd say to you, This is a market we know well.

Speaker 1

We've been in this market for a long time. We're obviously the clear leader in this market. So it's a market we know extremely well. And obviously, we know any trend that's occurring in this market to a high degree of detail. And what I would tell you is that we see no fundamental change in the way pricing Is being dealt with in this marketplace nor do we expect to see any fundamental change that occurs in the foreseeable future.

Speaker 1

So that brings me to the rebate question in the Q1. And I would tell you that we're operating The same way we have historically operated in this segment as it relates to rebating or discounting.

Speaker 12

When we

Speaker 1

get a new indication or when we get a new product, one of the things that we evaluate is, okay, what level of rebating should we do in order to maximize 2 things for the product. The speed at which we can drive the ramp and the ultimate peak sales that we can drive for that asset. We weigh those two things against how we look at contracting and getting on formulary. And so when you get an indication, you make a trade off of do I want to be on formulary or don't I? If I do, I have to provide some level of incremental rebates.

Speaker 1

Is that a financially positive decision for the asset and the company? And if it is, we make that decision. And I would say that SKYRIZI and RINVOC are classic examples of that strategy. And I would say, look at how they're performing. We're going to grow those 2 assets despite the increased rebates, dollars 3,500,000,000 this year.

Speaker 1

And that's a pretty good trade off. I don't know, Jeff, anything you'd add?

Speaker 3

Yes. Maybe just to build on that point, Rick. I mean, This fact base of 7 indications in 1 year in 1 category with 1 firm, it's just it's really unprecedented. It's not going to happen again. And I think it's important, think about how it works.

Speaker 3

I mean, when you get a new indication and they're sequencing over time, you've got to clear the payers' P and T clinical Committee and they don't meet every day. They meet every couple of months. So there's a process there. And then you've got to be added to the formulary Sure. So either have to somehow gain a new spot by indication or replace a competitor, and that's not easy as well.

Speaker 3

And so that's why what we see in the marketplace, Many competitive firms have to offer these free or bridge programs and not just for a quarter or 2, sometimes they're multiple quarters or years until that And I would say in contrast, Rick, as you noted, on average, we achieved fully paid access For those 7 indications in about 60 days, really, really unprecedented. So that means we had to give Very little free goods. We had almost immediate paid access and profit flow. And then of course that rapid revenue accumulation that you highlighted. So Definitely the right trade off and we don't see that recurring.

Speaker 2

And then Tim on your second question, we've said this For the high single digit price impact this year is a function again as Jeff mentioned 7 new indications. We do not expect that type of price erosion going forward. It should not be what Investors are modeling. So I wouldn't be concerned about high single digit price erosion in 2024.

Operator

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

Speaker 8

And that will be from Geoff Meacham, Bank of America.

Speaker 16

Great. Good morning, guys. Thanks for the question. On OUS, Samira, you're obviously well past the initial biosimilar wave, but you're still seeing some sequential decline. What's the context here and is there a dynamic that could impact SKYRIZI or RINVOC even indirectly OUS?

Speaker 16

And then on niviteclax, I know you guys have more details to come, but is there a threshold you're looking for and TransformONE To move forward or even to inform development and other indications, just thinking about maybe the tolerability profile and the comps in MF. Thank you.

Speaker 2

So Jeff, this is Rob. I'll answer your question on international HUMIRA. If you look at the 2023 erosion, it's about $600,000,000 It's really split in I'd say 3 buckets. About $300,000,000 of it is new biosimilar markets, markets like Canada, Puerto Rico, Mexico. Those are remember we have additional waves coming in.

Speaker 2

So that's The next wave coming into about half of it is that. And then I'd say I'd characterize about $200,000,000 being really the impact of new agents like SKYRIZI and RINVOC, right? So you have Agents that deliver higher standard of care and so you're going to see share erosion just through that dynamic. And fortunately, we've brought forward our own Products that do that. And so I'd say of that 600, 200 is roughly that.

Speaker 2

And then in the international markets, you typically see Some, I'd say, low to mid single digit price erosion, just typically year over year. So that's about another 100,000,000 It's important to characterize it the right way. It's not so much markets that were biosimilar several years ago. It's more recent biosimilar markets, our own competition from our own agents as well as the typical price erosion you see in the international market. Hi, it's Rupal.

Speaker 2

I'll take the navitigalax question. So we'll continue to monitor the spleen volume reduction and see How that looks towards the end of the year and if it maintains the high level that Tom described, that's something that is definitely a positive. The other things that we'll get that will reveal themselves over the longer term is the marrow fibrosis And that along with the spleen volume reduction and actually some of our earlier data may be correlative for survival events. So we'll get an early look at those. And then in terms of tolerability, what we've Seen thus far is consistent with what we've seen initially and it is a titratable dosing.

Speaker 2

So the clinicians can tailor in the study to what the patient needs. So more to come by year end.

Operator

Okay. Thanks, Jeff. And that concludes today's conference call. If you'd like to listen a replay of the call, please visit our website at investors. Abbvie.com.

Operator

Thanks again for joining us.

Speaker 8

As we are concluded, again, thank you for your participation. You may please disconnect at this time.

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Earnings Conference Call
AbbVie Q2 2023
00:00 / 00:00