Good morning and good afternoon, and welcome to the Novartis Q2 2022 Results Release Conference Call and live webcast. Please note that during the presentation, all participants will be in a listen-only mode and the conference is being recorded. After the presentation, there'll be an opportunity to ask questions by pressing star and one at any time during the conference. You will then hear an automated message advising your hand is raised. Please limit yourself to one question and return to the queue for any follow-ups. A recording of the conference call, including the Q&A session, will be available on our website shortly after the call ends. With that, I would like to hand over to Mr. Samir Shah, Global Head of Investor Relations. Please go ahead, sir.
Thank you very much, and thank you to all of you who joined us today on this beautiful summer's day for Novartis's quarter two results. Before we start, I'll just read you the safe harbor statement. The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties, and other factors. These may cause actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. For a description of some of these factors, please refer to the company's Form 20-F and its most recent quarterly results on Form 6-K. Those respectively were filed with and furnished to the U.S. Securities and Exchange Commission. With that, I'll hand across to Vas. Thank you.
Thank you, Samir, and thanks everyone for joining today's conference call. We're pleased to go over the results. I have with me today, Harry Kirsch, our CFO, and Karen Hale, our chief legal officer. Moving to slide 4. As you saw in the release earlier today, we delivered a solid quarter two across each of our key value drivers. 5% growth across the entire company, as well as in innovative medicines and Sandoz. Continuing our productivity agenda with solid core operating income growth across the business, as well as continued margin expansion in constant currencies, as well as an upgrade to our expected savings from our transformation program to now $1.5 billion. Some innovation milestones. Notably, we continue to garner approvals for Scemblix, our new medicine for CML, including a positive CHMP opinion. Lastly, 3 milestones within our ESG efforts.
First, a $250 million R&D commitment as part of the Kigali Declaration on Neglected Tropical Diseases. We've increased our commitment to clinical trial diversity over the next 10 years through our Beacon of Hope project. We also had an upgrade from MSCI to now an AA re-rating top quartile within the industry, and we continue to work to further improve our overall ESG profile. Moving to the next slide. When you look at innovative medicines sales, we grew consistently across the U.S. and in our ex-U.S. markets, primarily driven by our key growth drivers. We had 6% sales in the U.S., 5% sales ex-U.S. You now see on the right-hand side of the chart, 59% of our sales come from our key growth drivers, and those key growth drivers are now growing at 21%.
Moving to the next slide and zooming in a little closer on the quarter, you saw pretty consistent performance across our key medicines, and we'll go through this in a bit more detail. Two products I wanted to particularly call out. Kesimpta had a very strong quarter, I think demonstrating its overall profile as a multiple sclerosis therapy of choice. Kisqali as well is now gaining momentum in metastatic breast cancer patients, and we'll talk a little bit more about that throughout the call. Moving to the next slide. We've really focused attention as a company on six key growth drivers, we believe, which will enable us to deliver the growth profile we've outlined, both in the next five years and also beyond.
Notably Cosentyx and Entresto continue their outstanding performance towards their respective peak sales goal. We'll talk more about Zolgensma, which continues its global expansion. Kisqali and Cosentyx I've already mentioned. Leqvio, we're building a strong base with which we believe will enable this medicine to reach a significant sales potential over time. Taken together, these six brands now constitute 32% of innovative medicine sales, and they're growing at 31%. I think giving confidence in the growth outlook that we've outlined. Now moving to slide 8 and going through each of these key brands, starting with Cosentyx. Cosentyx delivered 12% sales growth on the quarter. When you look at that, the outlook for Cosentyx, we continue to guide to a double-digit growth driven by steady volume growth in the key geographies U.S., Europe, and China.
We're very confident in the overall clinical profile now that we've treated over 700,000 patients across five of the indications indicated for Cosentyx. We've continued to get important guideline recommendations, including the GRAPPA psoriatic arthritis guidelines, which highlight Cosentyx unique benefit versus alternative therapies, including the IL-12/23s in its ability to tackle axial manifestations of this disease. Overall, we're confident in the $7 billion+ peak sales potential. This will be driven by global expansion of the product as well as lifecycle management, where we had some good progress in the quarter, including approvals in pediatrics in Europe. We've submitted hidradenitis suppurativa in EU, and we expect to submit in the U.S. in the second half. We have positive data on an IV study looking at Cosentyx use in axial spondyloarthritis.
Lastly, we do anticipate an IV submission in the US as well in psoriatic arthritis for proof points of our ongoing efforts on lifecycle management for Cosentyx. Now moving to the next slide nine. When you look at Entresto is continuing its really dynamic growth, globally and in the US. You can see we delivered 33% growth with Entresto. Our weekly NVRX continues its strong progression, with continued strong growth. We've now treated over 7 million patients globally and over 1 million patients in the US, growing in hospitals, cardiology, and primary care. Really strong growth across geographies. We're confident in the future growth in delivering the $5 billion+ peak sales potential for this brand. There's only 1/3 of the addressable population that's been treated.
We see a strong profile consistently, regardless of the setting the medicine is used in. Lastly, with the approval of Entresto in hypertension in Japan and China, where there's a high unmet need, it gives another opportunity for future growth. Now moving to slide 10 with Zolgensma. Zolgensma is continuing to demonstrate the power of a one-time gene therapy to treat really in a dramatic way a terrible disease like SMA. 26% growth driven by global expansion, 2,300 patients now treated. We had recent reimbursement decisions, positive reimbursement decisions in Australia, Switzerland, and Greece. We recently received approval for our North Carolina new manufacturing facility, which further expands the capacity of our gene therapy network and really brings online a state-of-the-art facility, continuing our leadership in the gene to AAV gene therapy space.
Now, future growth drivers for Zolgensma are gonna be that continued global expansion, 43 countries to date and growing. We also wanna enable stronger newborn screening programs outside of the United States. 97% of newborns are screened in the U.S., but only 30% in Europe, and those numbers are similar or lower in many other geographies. As we can get more newborns screened, then we believe Zolgensma is the treatment of choice for these babies, allows for normalization of their overall development. We saw that in a Nature publication that recently summarized the data from one of our earlier studies, with 14 out of 15 patients walking alone and 11 of them in the normal development window when treated early with Zolgensma.
I also wanna note that both our STEER studies and STRENGTH studies are progressing well, and we continue to outlook a submission in intrathecal for Zolgensma for 2 to 18-year-olds in 2025. Moving to the next slide with Kisqali. We continue to deliver double-digit growth. You see 43% growth, and we see this as a brand that, given its recent data releases, is really coming into a strong profile, a strong growth profile. We're seeing increased traction based on the clinical data, and I'll talk more about that a little bit later in the presentation. We saw that at ASCO, once again, we were able to highlight some of the datasets, particularly around OS in the first-line setting, which demonstrates the strong profile of Kisqali.
The NATALEE adjuvant study primary analysis is expected in 2023 and continues to progress on track. I'll talk more about that in the pipeline section. Now moving to Cosentyx on the next slide 12. The launch is continuing and really continuing on a strong trajectory. We see an acceleration of the brand in the US, and we continue to work towards providing the medicine globally in our key markets. We have US demand of 18% growth quarter- over- quarter. We have 3,200 adopters, physician adopters since launch. You can see the NVRX up now 42%. It's a really dynamic growth for this medicine. We're working to continue to strengthen the profile and differentiation.
We have new extension data, which demonstrated eight out of ten patients treated continuously with Cosentyx had no evidence of disease activity. From an operational standpoint, we continue to work to drive fast initiation. Patients are now getting on therapy within 6 days, 80% of patients achieving that goal. 77% of patients remain on therapy at 12 months, which I think again demonstrates the medicine's impact as well as its ease of use for patients. Very excited about the outlook for Cosentyx. Moving to the next slide, on slide 13. With Leqvio, we're laying the foundation, as we've outlined in 2022 for the ramp we expect over the coming years. We continue to expect in the remainder of 2022 for a steady ramp-up of Leqvio.
I think there's important proof points that we're beginning to lay that groundwork successfully. First, with respect to access, and as a reminder, Leqvio is under the medical benefit. We have 65% of patients now covered with aligned to our label or near our label, and that's within six months of launch. This is higher than relevant competitor brands, both from PCSK9 monoclonal antibodies and/or other recently launched anti-cholesterol therapeutics. Those brands have been on the market for many years. I think it demonstrates we've been able to drive fast access, and the J-code now is in place as of July 1. I think from an access perspective, we're progressing well, progressing on or ahead of our plan, and I think that sets us up well for the future.
Secondly, on affordability, we can now confirm that two-thirds of patients have zero copay for Leqvio, including Medicare Part D patients with supplemental insurance. This again, we believe, will enable a strong uptake and strong adherence to this medicine so patients can get the benefit that they need from lower cholesterol. Lastly, we're making progress working through logistics and administration for this medicine in cardiologist offices as well as in relevant hospitals and medical centers. We've increased the number of unique locations ordering Leqvio to over 700. We're expanding the depth now with 55% of our customers already having placed repeat orders. We're seeing growing usage now with 2,100 HCPs and now 3,900 patients in the service center.
All of this taken together, I think points to a strong future for the brand, and we'll continue to work through the second half of this year to build out this base to enable long-term growth. Moving to the next slide 14, with Pluvicto, and moving to our two recently launched medicines in oncology, Pluvicto and Scemblix. The Pluvicto launch is really progressing in a strong manner, and it's either at or above our own expectations. We've seen our manufacturing issues remediated, and we've cleared our backlog. Commercial and clinical supply resumed in June. We have a permanent J-code that was granted in July, and that'll be effective in October. Over 50% of insured lives now are covered. We have over 100 RLT sites now operational. 40 sites have completed orders.
A strong trajectory from the start, and we're hoping to maintain that over the coming months. We're preparing for further expansion with this medicine, given the clinical profile we've seen to date. Both the phase 3 studies are on track, both in the pre-taxane setting and the hormone-sensitive setting, with a readout for the pre-taxane study still slated for before the end of this year. The manufacturing scale-up is ongoing. We have a new facility in Indianapolis that we plan to bring online in the second half of next year, and we have capacity and our expansions ongoing in our Italy and New Jersey sites. We're making significant investments to ensure logistics can support access as the patient population that can be reached by radioligand therapies continue to expand across Pluvicto, Lutathera, and our pipeline. Moving to the next slide 15.
Scemblix, as well, is off to a very strong U.S. launch, and then we achieved the, as I noted earlier, important regulatory milestones in the EU. $31 million of sales, primarily, driven in that third-line setting, 44% share in the third line, which I think is a good marker given how recently we launched the medicine, and 16% NBRX share regardless of CML line of treatment. In terms of future growth for Scemblix, it's gonna be driven by the first-line study, which is enrolling ahead of plan. This, as a reminder, is versus investigator choice of TKI. The CHMP positive opinion in the ex-U.S. markets where we continue to work to get a global rollout of the medicine. Moving to the next slide and turning to Sandoz.
As you saw, Sandoz had a really solid quarter in quarter two, and we've raised the full year guidance for Sandoz, and Harry will talk a little bit more about that. When you look at the drivers for Sandoz sales performance, it's primarily in Europe, where we are a leader or the leading generics company with 4% growth, driven by both launches as well as recovery of the healthcare systems. We had double-digit growth in the rest-of-world markets, Japan and other emerging markets. We've seen a stabilization in the US business, setting us up with future biosimilars launches and small molecules launches to drive growth in the US over the years to come. You can see our retail sales growth in the quarter was 4%. Biopharma was up 11%. We've raised the guidance as mentioned.
When you look longer term, we believe this creates a solid base of growth for growth 2023 and beyond. Now a lot of that will be driven by the biosimilars portfolio. The portfolio of biosimilars in Sandoz targets $80 billion of originator sales, over 15 assets in the portfolio, and some recent progress, including the acceptance of the Adalimumab high concentration formulation, as well as omalizumab in the EU. We also continue to pursue small molecule opportunities to build diverse small molecule portfolio. Overall, the strategic review for Sandoz is continuing to progress on track, and we expect an update at the latest by the end of this year. Moving to the next slide, on slide 17.
Our broad pipeline of novel medicines progressed in quarter two, but we've also worked to focus our efforts, as you saw in both our earnings release as well as with some of our pipeline decisions. Five core therapeutic areas while being opportunistic in other therapeutic areas. We're trying to make consequential decisions to really ensure we're focused in getting scale in those five core therapeutic areas. On this slide, a few things to highlight. We had important designations and milestones. Scemblix, I'd mentioned. pelacarsen completed enrollment for the phase 3 Lp(a)HORIZON study, so on track on its journey to become the first medicine to treat Lp(a)-driven cardiovascular outcomes. JDQ443, our G12C inhibitor for solid tumors.
The Phase 3 study in second- and third-line non-small cell lung cancer was initiated, and we continue to also progress combination studies for that medicine. Cosentyx had a filing for hidradenitis suppurativa in Europe, and we continue to work towards the U.S. filing. Then lastly, we continue to streamline the portfolio. We had a number of projects that we made the decision to either partner or stop. Notably, we're exiting our development efforts in COPD and general asthma with the decision to partner two assets in that portfolio. We'll continue to look to streamline the medicine portfolio in our pipeline so that we can focus on the medicines that matter most in our core therapeutic areas. Moving to slide 18, I did wanna say another word on Kisqali.
Given the OS benefit now we've seen across all three, all three of the phase three trials in the metastatic setting we've conducted to date. On the left-hand side, you can see the results that we've generated in the first line of metastatic setting. You can see impressive risk reduction, but importantly, median OS that's been achieved, consistently across these three studies, the longest median OS, ever published, and we've seen that same OS benefit regardless of situation. We also maintain that benefit even after prior CDK4/6 use. We think this data set is part of the reason we're seeing the real growth acceleration behind Kisqali.
Now in the middle, frame, you see that the reason for this clinically, we believe, is that Kisqali is unique in its ability to hit the CDK4 target, and we hit it 8x harder than we hit, CDK6. That's relevant, because we believe CDK4 is the key driver of the benefits you're seeing for this, medicine. You can see our relative performance versus in preclinical studies versus our competition. Now, when you look at the adjuvant study, it's fully enrolled, as we've already noted. We've already cleared, the first futility analysis. The primary analysis is planned at 500 IDFS events, and we expect that, by the end of 2023. The two interim analyses are to be conducted at 350 and 425 events.
We have not yet reached the first of those interim analyses. We expect that in the coming quarters. We do guide for this study to really complete at the end of next year when we reach a full number of events, but we'll of course keep the markets updated as we progress through these interim analyses. Moving to the next slide, on slide 19, you know, we're on track largely against our key 2022 events. Just three things to note, three submission enabling readouts coming up in the second half of this year, CANOPY-A, iptacopan in PNH, and as already mentioned, Pluvicto in the pre-taxane setting. We'll look forward to those study readouts and updating all of you as we get that data in-house.
With that, I will hand it over to Harry.
Yeah. Thank you very much, Vas. Good morning and good afternoon, everybody. I'm now going to walk you through some of the financials for the second quarter and the first half. As always, my comments refer to growth rates and constant currencies unless otherwise noted. On the next slide, yes, we show our quarter two and half one financial results summary. As you can see, quarter two sales and core operating income both grew 5% in constant currencies, with sales benefiting from the continued strong performance of our key growth brands and core operating income growth driven mainly by the higher sales. However, operating income and net income declined significantly in the quarter. This was mainly due to prior year divestment gains from tail end products and higher impairments and higher restructuring costs this quarter, mainly for the transformation for growth program.
Core EPS grew 1%. However, if you exclude the impact of the prior year Roche income, core EPS would have grown 10%. Overall, we delivered solid sales and core operating income growth for the quarter, resulting also in a strong operational half one performance, with sales growing 5% and core operating income 7%. Core EPS in half one grew 11%, excluding the Roche stake impact. On the next slide, I would like to drill down a bit into the performance by division. For quarter two, you can see that Innovative Medicines top line grew 5% and the bottom line 6%, resulting in an improvement in the core margin of 15 basis points to 37.2%. Sandoz net sales also grew 5%, although core operating income decreased 4%, mainly due to increased M&S investments and higher other expenses.
This was reflected in the core margin, which decreased to 20.4%. Overall, for the first half, we saw strong performance for Innovative Medicines and Sandoz. Innovative Medicines sales growing 5% and core operating income 6% in half one. Sandoz grew 6% on the top line and 10% on the bottom line in half one, driven by a very strong quarter one. As a reminder, as we discussed in April, Sandoz benefited from a return towards normal business dynamics compared to a lower prior year base. Our half one core margin improved by 30 basis points for Innovative Medicines, 70 basis points for Sandoz, and 60 basis points for the total group. Turning now to our guidance on slide 23.
Within the divisions, we expect Innovative Medicine sales growing mid-single-digit and core operating income growing mid- to high-single-digit ahead of sales. The expected IM core margin increase will be driven by expected continued good top-line momentum and continuation of our productivity programs, of course, including the new organizational structure, giving us some benefits in the second half already. For Sandoz, the performance year- to- date allows us to upgrade sales guidance to grow low-single-digit, which is a one-notch upgrade, and core operating income guidance is upgraded by two notches to now be broadly in line with the prior year. For the group, we confirm our overall full-year guidance. We continue to expect both top and bottom line to grow mid-single-digit in 2022.
The key assumption for this guidance is that we see a continuing return to normal global healthcare systems, including prescription dynamics, and that no Gilenya and no Sandostatin LAR generics would enter in the U.S. in 2022. As many of you know, in June of this year, the U.S. Appeals Court held the Gilenya U.S. dosing regimen patent invalid. We plan to petition the appeals court for further review to uphold validity of this patent. As a reminder, there's no generic competition in the U.S. at this point in time for Gilenya, and in quarter two, U.S. sales were $332 million for Gilenya. It is worth noting that U.S. Gilenya sales have been steadily declining due to competitive pressures and of course our key focus in multiple sclerosis being on Kesimpta. Next slide, please.
I would like to provide some further details on the expectations for the second half dynamics on top and bottom line. We expect sales to continue to grow mid-single digits, bringing us to our guidance for the full year. For half two core operating income, we expect to grow slightly slower compared to half one at low- to mid-single digit. This is mainly due to the higher prior year base for Sandoz in half two. As you know, half one core operating income growth benefited partly from a very low prior year base at Sandoz. We will of course continue to monitor the impact of inflation and utility costs, particularly on the Sandoz product portfolio, as well as the situation around COVID-related lockdowns in China, given that we are seeing improving signs as of June, which we will continue to monitor in half two.
On the next slide, I would like to provide an update on our new simplified organization model and the financial impacts of the restructuring. As Vas discussed earlier, we have increased our estimate of SG&A savings to approximately $1.5 billion. We anticipate the savings to be fully embedded by 2024. This year, we also expect some savings, but the overall impact will be minimal as we will be offsetting higher energy costs and inflationary pressures. Part of the $1.5 billion savings we expect to be reinvested into our pipeline and a significant part will contribute to achieve our mid- to long-term low-40s innovative medicines core margin guidance.
With regards to the one-time restructuring costs, we could narrow this range a bit, and we estimate this now to be 1-1.2 x of the annual structural savings of CHF 1.5 billion. On slide 26, I want to provide an update on expected currency impacts if currencies stay at the current levels. Obviously, currency impacts are significant this year given the strengthening U.S. dollar against many currencies. If currencies stay as they are now, for the full year, we estimate the impact on top line to be negative 6-7 percentage points and on the bottom line, negative 7-8 percentage points. Given it's volatile, we wanted to give you also a bit of a outlook for 2023.
For the full year in 2023, we would expect sales to be impacted by -2% and core operating income, negative -2% to -3% in 2023 versus 2022. As a reminder, we update these currency impacts on our websites monthly. I think especially in these times, quite important to watch that. Finally, on page 27. Thank you. Finally, a reminder about our capital allocation priorities, where we remain disciplined and shareholder focused, of course. We aim to balance investing in the business with returning capital to shareholders via our dividend and share buybacks. In the first half, our investment in the organic business was $4.5 billion in R&D and $500,000,000 in CapEx. We also had bolt-on M&A, which was around $0.9 billion, mainly for the Gyroscope Therapeutics acquisition.
Alongside this, as you can see in terms of returning capital to shareholders, we paid our annual dividend of $7.5 billion earlier this year and have $9.4 billion still to be executed of our ongoing $15 billion share buyback program, of which we have completed $5.6 billion by the end of June. With that, I hand it back to Vas.
Thank you, Harry. If we move to the last slide 29. We continue to progress against our top 2022 priorities as we've outlined. Successful launches, particularly ensuring the foundation is laid for Leqvio, but driving the dynamic performance of Cosentyx, Kesimpta, Entresto, which as you've seen, are continuing apace. Maintaining the growth momentum across our six key inline growth drivers. Progressing the pipeline where we have 20+ assets where we expect significant sales potential with approval potential by 2026, and the pipeline is on track. We're tracking well on our Sandoz review and with a solid quarter from Sandoz in quarter two. We will keep you updated as we move towards an update before the end of 2022 at the latest.
We remain disciplined in our business development, looking for important opportunities to build out our pipeline, but remaining disciplined with how we allocate our capital. Continuing to deliver our returns, and you've seen that with our productivity initiatives, our increase to $1.5 billion of SG&A savings with our new organizational model. We continue to reinforce the foundations we believe that in the long run will drive Novartis' performance around culture, data science, and as I noted earlier, ESG. With that, we look forward to taking your questions. If the questioners could please limit themselves to one question, we will be able to get through hopefully the list and allow people to ask multiple rounds over the course of the call. Operator, we can open the line for questions.
Thank you. As a reminder, to ask a question, you will need to slowly press star and one on your telephone keypad and wait for your name to be announced. Once again, star and one if you would like to ask a question. We will now take our first question from Matthew Weston from Credit Suisse. Please go ahead. Your line is open.
Thank you very much. A question on Kisqali, please, Vas. You were very clearly set out the interim analysis timelines and the final analysis timeline. One question that we've received a lot in recent weeks is how you would communicate when you go past an interim. Would you consider that a material event which you have to press release to the market? Obviously, if it's positive, it would be positive and we'd see a release. But if you simply pass an interim and move forward, would you see that as requiring a press release, or would we simply learn that at the next quarter where you would update the timeline? Many thanks indeed.
Yeah, thanks, Matthew. I think as you outlined, clearly, if at any time in a study that we either get a definitive positive result as determined by the DSMB or a negative result, we would update the market. Otherwise, our plan would be at the quarterly calls to provide updates on where we stand on the study. We don't believe passing an interim analysis warrants any sort of further update. Thank you very much, Matthew. Next question, operator.
Thanks. I'll jump back in the queue.
Thank you. Your next question comes from the line of Tim Anderson from Wolfe Research. Please go ahead. Your line is open.
Hi. Just a high-level question on healthcare reform and just, you know, talk of reconciliation pushing ahead. Seems like it's finally gonna happen, to us at least. Your thoughts on the likelihood of this happening and what it could mean to industry financials and to Novartis specifically over time, and if you have certain products that you think would be impacted the most.
Yeah, thanks, Tim. I think as everyone is reading in the press, there is renewed momentum behind a reconciliation package which would consist of a drug pricing reform, and supporting ACA subsidies. Of course, our overall view remains that there are good and bad elements to the package. Clearly, Part D reform is needed. Capping patient out-of-pockets will be, I think, a positive step, enable patients to fill their prescriptions and also enable from our sector demand to be supported. Of course, there are onerous elements as well, which we think go too far and don't support long-term. Innovation will have detrimental effects to the long-term outlook for the industry, particularly the negotiation elements.
Now, for Novartis specifically, we view these as not significant impacts in the near to midterm. We've analyzed this quite in a detailed manner. I mean, I think as is well known, we are the number one company, pharmaceutical company in Europe and a leader in many emerging markets. Our business in the U.S. is one we plan to grow significantly over time, but our relative exposure to the peer set, in terms of both government programs and overall U.S. sales is at the low end of the peer set. We would expect to have a far lower impact on us relative to our peers.
I would say in the near to midterm, not a significant impact overall net of the positives we get from the Part D reform and of course, the impact from inflation caps, as well as negotiations. That's how we see it at the moment. Of course, we'll continue to analyze as the final bill text is available.
Thank you.
Next question, operator.
Thank you. Your next question comes from the line of Richard Vosser from J.P. Morgan. Please go ahead. Your line is open. Hello, Richard, your line is open. Are you on mute? As there is no response from Richard, I will go to the next person.
Hello. Sorry.
Cool.
Sorry, apologies. Completely my fault. Just on Kisqali, if you can hear me now, just wanted to go back to the growth potential in the first line opportunity and how much of the Ibrance market you think you can take with the OS benefit. Obviously we can see Verzenio benefiting as well, but just your thoughts there. Thanks very much.
Yeah, thanks, Richard. You know, with Kisqali, we're starting to see a positive trend on NBRX in the first half of the year versus the competition, and in the metastatic setting. That comes, you know, primarily from Ibrance, and I think that's reflective of the data set that we have in OS, as I've outlined. It's important to note as well, in many European and ex-US markets, we are either number one or close to number one, depending on the market. We believe we can drive additional momentum in those ex-US markets as well. I think it's positive signs. We wanna see that trend continue for hopefully a couple more quarters, particularly given that now the dynamic market within breast cancer is starting to recover.
I would note it's just recently on our data coming back to where it was pre-COVID, which again is an opportunity for us to gain share as there's an opportunity to get either new patients or switching patients onto Kisqali. I think it's all positive directions and we'll see how the trend goes in the coming months. Thank you, Richard. Next question, operator.
Thank you. Your next question comes from the line of Emmanuel Papadakis from Deutsche Bank. Please go ahead. Your line is open.
Thank you for taking the question. Perhaps I'll take one on Sandoz, please. As you called out, biosimilar is clearly the key to returning to reasonable levels of growth in the midterm. You recently filed the biosimilar Humira, Hyrimoz high dose in Europe. Could you just give us an update on where you are with respect to the U.S. for that opportunity, i.e., both as regards to high dose filing and potential interchangeability, and how significant an opportunity you think that may be for the business, and indeed whether that would have any influence on your considerations for strategic options? Thank you.
Yeah, thanks, Emmanuel. We're on track overall to be launching Humira or the adalimumab biosimilar at market formation in the U.S., and it's our intention to have the high concentration formulation available. I think as soon as we have a file accepted by FDA we would of course put out a release and update the market. I would say overall, we're on track with respect to that. I think clearly the number of entrants when the adalimumab market formation happens will mean that it will be a highly competitive market set, but nonetheless, given the size of the opportunity, it will help meaningfully drive growth for the brand. I would also note that natalizumab, where we are one of the early entrants is a significant opportunity for Sandoz.
I think Natalizumab, both in the U.S. and Europe, is one we're excited about as an opportunity to drive growth within the next few years. The other upcoming opportunity for us is Denosumab, where again, I think we would be one of the earlier entrants among biosimilars players. Those would be the three key upcoming biosimilar launches for Sandoz and particularly in the U.S. Next question, operator.
Thank you. Your next question comes to the line of Graham Parry from Bank of America. Please go ahead. Your line is open.
Graham, thanks for taking my question. I've got another one on NATALEE, actually. I think at the Q1, Vas, as you said, you were at 300 events. I wonder if you can give us an update on how many events you're at in the trial. Is that the sort of event rate as it sits, but you still have a couple of months delay before the DMC reports to you on what the outcome of those interims are. In the event you were to get positive data, to what extent can you put subgroup analysis, et cetera, in the press release?
Whether you've hit, you know, across all subgroups, high risk, low risk, et cetera, just what would be in the press release would just be quite interesting to know. Thank you.
Yeah. Thanks. Thanks, Graham. On Kisqali, obviously don't wanna get into what exactly the number of events are. I would say the event rate that we've seen, as we noted previously, we had a slower event rate than we had originally projected. That event rate has continued. There's no change in the overall event rate. I would also note that you are correct that from the point of a lock, it does take a few months to get the readout with the DMC, and particularly because we work with one of the large CROs in the U.S. as part of this study. That's, I think, important to note from a timeline standpoint.
In terms of what's in the release, I mean, I think we typically would only comment on the primary endpoint, and in this case, that's IDFS across both the medium and high-risk patient populations. We wouldn't, of course, get into subgroups. I would also note that the DMC's primary basis for stopping the study would be IDFS. We would hopefully see an OS trend, but I think that's an important note as well. I would expect that as would be the case normally in such an oncology study, OS takes more time to mature. Of course, we'll have to see how it all unfolds over the coming quarters. Next question, operator. Thank you, ma'am.
Thank you. Your next question comes from the line of Steve Scala from Cowen. Please go ahead. Your line is open.
Hi, can you hear me?
Yes.
Hi. Hi, this is Steve Scala. On remibrutinib, is there any sign of liver tox similar to Sanofi's tolebrutinib? Is there any reason to believe that liver tox is a class effect? Thank you.
Yeah, thanks, Steve. You know, we've been watching the space very closely. I mean, when you look overall at BTK inhibitors in cancer, historically, liver has not been a signal, at least to our knowledge, that's been a significant concern. Also BTK is not differentially expressed within liver. In our view, this is related to the drug itself, either metabolites or off-target toxicities in the liver. To date with remibrutinib, we haven't seen any liver signals. We've taken it forward into chronic spontaneous urticaria as its first lead indication, where there are two pivotal Phase 3s ongoing. Then similarly, now are progressing in our MS studies and also evaluating taking the medicine into other areas of rheumatology, dermatology, et cetera.
Our hope and expectation is that the profile of remibrutinib continues to be clean relative to the peer set, particularly with respect to liver signals. We believe that in the MS market, but also in the dermatology markets, it's gonna be critical to have a medicine that has a safe profile with especially with respect to more complex side effects like liver. That's where we stand, and we remain optimistic on that unique profile of remibrutinib based on its chemical design and the lack of any off-target toxicity seen to date.
Thank you.
Next question, operator.
Thank you.
Operator?
Oh, sorry, sir.
Yeah.
Your next question comes from Florent Cespedes from Société Générale. Please go ahead. Your line is open.
Good afternoon. Thank you very much for taking my question. A quick one on Kesimpta. Could you elaborate a bit on how would you see the dynamic on the ex-US sales? They are still quite small for the time being, but they are ramping up nicely. Could you give us what should boost these sales here? Thank you.
Yeah. Thank you, Florent. With respect to Kesimpta, already we covered the U.S. at length. I mean, we're starting to now move through, as you know, the longer reimbursement processes that required in Europe, Canada, and other global markets. We would expect to see in the second half and then moving into next year, more significant sales contributions from our ex-U.S. markets. Of course the big markets in Europe, but I was also recently in Canada, where there's a lot of excitement as well about the medicine. Then to a lesser extent, in Asia, Japan, et cetera, where MS rates are lower, but the market sizes are significant.
I mean, I think it's important to note in those markets a monthly sub-Q patient-administered drug is very attractive because of those markets there's not the same incentive structures around infused medicines as well as the ability to deload the hospital system by having at-home administration. We feel optimistic about the opportunity now for Kesimpta as its next wave of growth to really be about a global expansion of the medicine.
Thank you very much.
Next question, operator.
Thank you. Your next question comes from the line of Emily Field from Barclays. Please go ahead. Your line is open.
Hi. Thanks for taking my question. I just wanted to ask a question on the development plans for ligelizumab. I believe kind of the slides just mentioned food allergy, but you know, on ClinicalTrials.gov, the PEARL-PROVOKE study in CINDU still looks to be recruiting. Just you know, any update on the other indications? Thank you.
Yeah. With ligelizumab, as you know, we made the decision not to take it forward in CSU, but we continued the development program in food allergy. We'll complete the program as well in CINDU, and we continue to believe the medicine has potential in some of these indications where IgE inhibition has demonstrated the ability to impact symptomatic disease as well as the disease progression. We still think the medicine has potential, particularly in food allergy, where if we could find the right setting for its use and get a relatively broad label from the regulators, it would have a significant potential. Those development programs continue on track, and we would expect the readouts as we note in our documentation. Next question operator.
Thank you.
Thank you, Emily.
Thank you. Your next question comes from the line of Simon Baker from Redburn. Please go ahead. Your line is open.
Thank you for taking my question. A quick two-part product question, if I may please. Firstly, on Zolgensma. Vas, you talked about the strong ex-US growth, but actually the growth in the US was pretty impressive this quarter. I just wonder if there's anything to add behind that. Secondly, on Leqvio, I wonder if you could update us on the ex-US performance, particularly the UK. Thanks so much.
Yeah. With respect to Zolgensma, we were pleased as well to see the performance in the U.S. That's primarily driven by expansion in newborn screening, where you'll remember when we launched the medicine, we were down at 60%-70%, and now we're moving into the mid to high 90s%. As we get that newborn screening rate up, it tends to be the case that patients who are identified in newborn screening ultimately receive Zolgensma. I think that will continue as we move up the newborn screening, but then of course, we would expect to be back to a steady state. As with all gene therapies, eventually you get to the steady state of the ability to identify the diseases at birth in any so-called incident population.
When you look at the specifics on Leqvio, ex U.S., I'd say in the U.K. as well, we've been systematically building up towards what we hope will be a trend break. I think the U.K. NHS had to of course deal with COVID for much of the first part of this year. In the last few months, we've now successfully upgraded and enabled NHS EHRs to identify patients who would be able to use Leqvio. We have now, I think, over 70% of primary healthcare units with Leqvio available on their formularies. We've launched a large-scale education campaign in the U.K.
I would expect to see as well, hopefully a trend break in Leqvio in the UK in the first part of next year as we continue to build that foundation in the second half and as the NHS works through the backlog it has from, you know, other diseases because of the COVID pandemic. Beyond that, we see very strong uptake in Germany with Leqvio on a per population basis. The uptake is very good. We've signed successfully large scale agreements with certain Middle East governments to roll out Leqvio at scale in those markets. We also continue to work to bring Leqvio forward in the large markets of Japan and also are finalizing the plan for a filing in China as well.
I'd say all of that is going on course. Again, as always with cardiovascular launches, it takes time, but on this one, I mean, absolutely our goal is to ramp this medicine faster than we were able to in Entresto, and obviously with a runway that goes to the late 2030s, at the very least, a significant opportunity to make this a really significant medicine.
Thanks so much.
Next question, operator.
Thank you. Your next question comes from the line of Kerry Holford from Berenberg. Please go ahead. Your line is open.
Thank you for taking my question. Focusing on radioligand therapies and the recent manufacturing delays, can you now confirm that you do have a sole supplier or running an inventory build-up to both Lutathera and Pluvicto? I wonder if you can also elaborate on your plans for expansion of RLT manufacturing supply going forward and how you work around what you've learned through those recent delays. Is there any risk that the recent manufacturing gap could result in a delay to the ongoing phase 3 PSMAfore study, which I think is due by year-end? Thank you.
Yes. Thanks, Kerry. A couple of points on radioligand therapy manufacturing, which is a challenge, but also I think points to why if we can get it right, creates a long-term competitive advantage. This is a medicine where you cannot build inventory. We make the medicine, and depending on whether it's Lutathera or Pluvicto, we have between 3 and 5 days to get it to its relevant site. Because of that, you have to be world-class with respect to the supply chain. It's not something easy, I think, for anyone to build from scratch. What we've learned is to increase capacity with redundant lines in different manufacturing sites to enable us to ensure we have a steady supply if we were to have a disruption at any one of our sites.
Within those sites, to segregate the lines so that the one line having an issue doesn't affect any of the other lines. We've been able to do that now at the relevant sites, particularly in our Italian site, in our US site. With all of that being said, we've cleared the backlog. We are now shipping to order successfully. We're also with large centers moving to a model where we provide Pluvicto doses ahead, even if they don't have patients ready yet so that the supply is there. Of course, that enables them to book additional patients with confidence. To further expand the supply, we'll be bringing on a third large scale manufacturing facility in Indianapolis.
That'll actually have automated lines, moving away from more manual lines, which will just further increase capacity. We would expect by mid to second half of next year to have three separate U.S. manufacturing facilities to support the U.S. for both Lutathera and Pluvicto. Giving us the redundancy, large scale capacity and, of course, the ability then to fulfill what we hope if the data supports it, a potential multi-billion dollar opportunity for Pluvicto across lines of prostate cancer. I'd also take the opportunity to say that the feedback, both from the nuclear radiology community as well as the urology community, which is an important customer base for this medicine, has been very positive to date.
With respect to the phase 3 studies, we've been able to fully reopen enrollment, and we currently forecast no change in timelines, either for the pre-taxane study, which is slated to read out before the end of this year, or the hormone-sensitive study, which is slated to read out in 2024. Both of those studies now are on track, and if anything, are enrolling slightly ahead of schedule. Next question. Thanks, Kerry. Next question, operator.
Thank you. Your next question comes from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead. Your line is open.
Great. Thanks. Just one quick question on iptacopan. I just wanted to get your thoughts on relative positioning in PNH and in aHUS versus the well-established C5 inhibitors. Just wanted to get your sense of the ability to compete in the treatment-naive setting, as well as the, you know, sort of, the patients that are struggling, as we look at this first data set, and then I think the treatment-naive data set will come in the first half of next year. Thanks.
Yeah. Thanks, Seamus. We've done a lot of work with the U.S. team here and really to understand the physician expectations and the dynamics. Overall, we believe that hematologists would be highly interested in iptacopan, both in the first line setting and for patients who are not achieving an adequate response to the anti-C5 monoclonals. I think unlike some of the other areas where, you know, Part B infused medicine can create a barrier, this is a low enough volume situation where we believe that patient ease of use to avoid having to come in and out of the hospital, also a very safe drug that can be used across lines of therapy would be highly attractive for physicians. You're correct.
The first data set will be focused both on add-on therapy as well as switch, and then we'll have a second data set, the APPLY-PNH study, which would then be in the front-line setting, and those two data sets together will support the overall filing. You know, we remain optimistic on that PNH, and that, of course, would translate as well into atypical hemolytic uremic syndrome in that setting. I'd also note that the opportunity for, as hopefully everyone on the call is aware, for iptacopan is not only in that hematology setting, but we also have a program in the renal setting, where this could be the first medicine approved for C3G glomerulonephropathies, as well as an opportunity to treat patients on the severe end of the spectrum with IgA nephropathy.
Then we continue to expand across a range of other Factor B, you know, driven diseases. The unique profile here is a twice-a-day oral with a very safe safety profile, which I think for these rare diseases, will hopefully make a lot of sense. Thanks, Seamus. Next question, operator.
Thank you. Your next question comes from the line of Andrew Baum from Citi. Please go ahead. Your line is open.
Thank you. Question on your BeiGene collaboration, a couple of parts. First, I'm curious whether you could provide some color on the FDA's guidance to you not to file in monotherapy. I assume that they have Western data. I think they do. I'm just curious as to why. Is it because they feel the market is well served, site inspections or some other? Second, you have an option on the BeiGene TIGIT. It sounds like Roche is now not gonna be presenting the interim data at ESMO. When do you have to exercise that option? Can you give us any guidance on what you will do given the available data?
Yeah. Thanks, Andrew. On the first question, on monotherapy, I think the FDA's assessment of our overall data set was that it didn't adequately reflect the US population in terms of the number of patients and the standard of care that was used in that Beijing-driven first line study. Our focus right now is to finish the filing in the second line esophageal cancer, and then we have very good data in the first line setting as well. As we announced, that's been pushed back as we await the ability for FDA to inspect the facilities in China. Then hopefully we'd be able to have both first and second line in esophageal.
We'd have then hopefully second line in non-small cell lung cancer, and we would expand from there. I do think that the FDA is making it very clear now that they expect any studies to be filed, that they're global in nature, they have an appropriate amount of U.S. patients, and that the standard of care used reflects a standard of care in the U.S. With respect to the anti-TIGIT, we haven't changed. No change from our option agreement. The option agreement is driven off of the data from ociperlimab, the BeiGene anti-TIGIT molecule. That option would be based on when their data set becomes available.
We'll continue to wait for that, their data to mature, which we'd expect, I think, if I'm not mistaken, but we can verify in the first or second half of next year. Now, in terms of the Roche data set, I mean, it doesn't change anything for us. We will continue to wait and watch as the field evolves and then make an appropriate decision. I think it's important that everyone would like to understand where is the appropriate use of this medicine, and in which PD-1 subgroup, all comers, and if there is a place, which place would it actually be? For us, there's no change to plan at this point in time. Thank you, Andrew. Next question, operator.
Thank you. Your next question comes from the line of Laura Sutcliffe from UBS. Please go ahead. Your line is open.
Hello. Thank you. Could you help us understand who the typical U.S. prescriber of Leqvio is, who's already prescribing to multiple patients or who is already a repeat prescriber? Thanks.
Thanks, Laura. It's a great question. I've spent three days now in the field here in the U.S. meeting clinicians, visiting hospital centers, visiting larger cardiology centers. I'd say right now, where we see the strongest uptake are in group cardiology practices where they already have the ability to buy and bill. They make their own decisions on how they wanna approach, you know, treating for cholesterol, and have, I think, the infrastructure largely set up and also the scale. I'd say group cardiology, mid to large size group cardiology practices have been really, I think, a key area so far for the medicine.
Combined with, I would say, large volume cardiologists and smaller practices who are leveraging alternative injection centers where we continue to see solid uptake. That's a solid base for us to grow from. The goal is to move into larger centers where you of course have to work through the pharmacy and the various P&T committees to get everything set up there. The J-code being in place and the overall clinical experience increasing is helping. Moving towards smaller cardiology offices where there is the need to set up buy and bill capabilities which historically have not been in place for those cardiology offices.
I mean, what I would say though is what I consistently hear, regardless, and I think our teams here on the ground, is a lot of enthusiasm for a twice-a-year physician-administered medicine that can modify the single most important risk factor in cardiologists' mind for preventing repeat cardiovascular events. I think seeing that and hearing that again and again gives us confidence, gives me confidence that we will work through the logistical hurdles, which seems to be the primary topic, and then get this medicine into wide scale use. I think we often hear back from practices, especially when they've put the patient on the medicine, and then at the next visit they see a significant drop in the LDL levels. That's, you know, a very winning proposition after a single dose.
I think those practices get really excited about getting more patients on therapy. Again, laying all the foundations, but I think that all the right steps are being taken to get us to where we need to be. Next question, operator.
Thank you. Your next question comes from the line of Keyur Parekh from GS. Please go ahead. Your line is open.
Hi. Thank you. Vas, a big picture kind of capital allocation question for you. If you look at slide 27, kind of first half, obviously it's only first half, which shows that you kind of returned somewhere about $13 billion kind of to shareholders versus investing kind of about $6 billion in businesses and, you know, kind of organic and bolt-on transactions. As we look forward to the next kind of 12-18 months, do you expect that balance to be somewhat similar to what we have seen in the first half? Do you expect that to be more counterbalanced by greater investments, either from an R&D or an M&A perspective for Novartis? Then just kind of more specifically, you are telling us that you'll provide us an update on Sandoz by the end of the year.
What is that update expected to be? Are we gonna get a decision on what you would do? Is it going to be if you plan to separate it, will we get details on structuring of separation, et cetera? Just any color you might be able to provide on what that detail or what that update might involve. Thank you.
Yeah, thanks, Keyur. I'll let Harry start, and then I can add on. Harry?
Yeah, thank you. Hi, Keyur. On the capital allocation, of course, the whole thing is a bit skewed by our dividend being an annual dividend, right? It's $7.5 billion. If you wanna do it mathematically, you almost have to half that and put it on two sides, but it's an annual dividend. Overall, of course, you know, all of these elements, R&D, we expect to continue to grow in line with sales at least, and so there will be continued growth on R&D investments. We don't expect margin leverage from the R&D line as we go forward. More from the SG&A line, where also our transformation for growth program is targeted at and where we have some gap to benchmarks, and we have found some structural opportunities, which is great.
In terms of how much it goes to bolt-on M&A, that obviously depends on the opportunities we find. Given our very attractive net debt position and strong cash flows and balance sheet, of course, we have quite significant bolt-on M&A firepower, if you will. If we don't find the right opportunities, of course, share buybacks will always continue to be part of the mix. In terms of Sandoz, I think you said it all. We make very good progress, align with our plans on the carve-out financials on looking at all different options. Would be, of course, happy to give a preliminary decision by end of year. You know, this is, of course, subject to board approval and from that and the progress overall on our whole planning.
End of year should be quite giving you some good hints to in what direction it goes, given that we take appropriate time for all the homework we are doing on the carve-out financials, separation costs, tax situations and all of that. It would be then the end of year later we should be in a good position to inform you about the next steps here. Vas?
No, it's perfect. I think Harry said it all. Thank you, Keyur. Thanks, Harry. Next question, operator.
Thank you. Your next question comes from the line of Naresh Chouhan from Intron Health. Please go ahead. Your line is open.
Hi. Thanks for taking my question. Some of the work we've done suggests that people costs are around 40%-50% of the total cost for the industry. My question is, how we should think about the timing of the inflationary impact on salaries. Is it fair to assume that on the whole 2022 salaries and therefore your guidance has factored in only last year's inflation and that really we have to wait until next year's salary rounds before we start to see this year's inflation baked into your cost base on the salary side? Thank you.
Thanks, Naresh. Harry, you wanna take that?
Yes. You are absolutely right. I mean, you know, the current inflationary effects mainly on energy, utilities, freight costs and so on are on those cost categories as we speak. On wages and salaries, not much yet, if anything. All right. That needs to be closely monitored, and I would expect this to come more in annual cycles. If there is something short term, it's probably depending on certain countries. Of course, we always monitor the markets to be very competitive. You know, we have, of course, quite a big, if you will, workforce in Switzerland where inflation and wage increases are below, I would say, developed market average. From that standpoint, our home base gives us also here a bit of competitive advantage. We have to watch it, right?
As you say, the wages and salaries are a large portion of the P&L of any pharma company, given it's innovation-driven and people-intensive business. We have to watch that and we'll monitor this of course. I would say we believe it is manageable for us, but we have to monitor how the situation develops.
Thank you.
Thanks. Thanks, Harry. Thanks, Naresh. Next question, operator.
Thank you. Your next question comes from the line of Sarita Kapila from Morgan Stanley. Please go ahead. Your line is open.
Hello. Thank you for taking my question. Please could you discuss where you stand on the development of the diabetes and obesity franchise? You have the MBL949 in phase 2. I don't believe the mechanism has been disclosed, but it appears to be dosed every 2 weeks. You also have an existing cardiovascular and metabolic commercial platform. There are a number of assets focused on diabesity in phase 1/2, which remain unpartnered. It looks like from today's update, respiratory is less of a focus, but it's not necessarily clear where you stand on diabesity and adding assets around Entresto, Leqvio and TQJ230. Thank you.
Yeah, thanks for the question, and noted the Morgan Stanley report as well on obesity. Yeah, I mean, I think we, of course, are observing the significant unmet need for better obesity medicines. Because we do have a dedicated cardiovascular research unit in-house, you know, led by Sean Coffey, a really, I think, global leader in the thinking on developing world-class cardiometabolic drugs, we do have assets in our portfolio. We have not disclosed MBL, but we are awaiting our phase 2 data on weight loss with MBL. If that's positive, that would be an exciting opportunity to hopefully address with a unique mechanism of action obesity on a large scale.
I think based on that readout, we would determine if we advance other earlier stage opportunities and combination partners we would have for MBL, as well as potential external opportunities. I think more to come. Certainly observing the need for better obesity drugs and hopefully alternative mechanisms to those already out there is something we're looking at, and we'll keep the markets up to date as we learn more.
Great. Thank you.
Next question, operator.
Thank you. Your next question comes from Peter Welford from Jefferies. Please go ahead. Your line is open.
Hi. Thanks so much for taking my question. A question on Cosentyx, please. You've talked a little bit about the aim for this year. I wonder if you could just talk a little bit about next year. In particular, you've also talked a lot about Humira biosimilars in your plan there in the U.S. Can you just talk a little bit about how you see coverage negotiations for Cosentyx next year? Perhaps you could just talk about the impact of HS, which I guess is unlikely to be approved for the negotiating cycle this time around. But IV, on the other hand, also available, and how you think that fits into the potential patient access dynamics for Cosentyx going into next year. Thank you.
Yeah. Thanks, Peter. I mean, I think right now our assessment is that with the introduction of Adalimumab biosimilars, it's a manageable situation. I mean, we already have significant gross to nets on Cosentyx in some accounts. In other accounts, we have very strong overall positioning and as a first-line therapy. Of course, we'll have to see as the upcoming year unfolds and also how some of the upcoming legislation that potentially might be passed by Congress will impact the gross to net environment, given that there would be, if the law is passed as currently designed, less ability to offset you know, increased rebates with price increases.
I think there is a possibility we see a rethink on rebating, at least on the industry side, on how the whole structure of the market works. It's all to be determined and to be seen. I mean, I think for us strategically on Cosentyx in the US, the goal is within rheumatology and dermatology to grow with the market, and you see healthy market growth in both of those categories. As you point out, expand both in terms of indications. We would hope to get hidradenitis approved over the course of next year, which then means in 2024, it would be an additional labeled indication for us and a unique labeled indication for Cosentyx, but also it to expand into with IV into other payment settings.
To have IV approved, hopefully across both axial SpA as well as psoriatic arthritis, would enable providers to also provide Cosentyx in those reimbursement settings. Hopefully that also helps us manage the overall payer environment. It's probably the best answer I can give at this point in time, but I think as we learn more in the second half of the year, as we enter towards the January negotiations in Q4, we'll keep you posted. Next question, please.
Thank you. Your next question comes from the line of Matthew Weston from Credit Suisse. Please go ahead. Your line is open.
Thank you very much. Just a couple of follow-on housekeeping items, please. Harry, the quarter we saw significantly lower finance charges and also significantly lower corporate costs than consensus was anticipating. I know there was a hyperinflationary write back in the finance charge. Can you give us any help with what we should anticipate for both those lines for the full year? If I can cheat and ask another question: Vas, you obviously deemphasized COPD within development. Does that mean that we can anticipate that you may consider divesting your legacy respiratory assets, or that's something where you're gonna maintain an existing commercial franchise? Thank you.
Harry?
Yeah. Hi, Matthew. Welcome to the second round. On the corporate costs, you know, we guided so far to $600 million-$650 million this year. Our new guidance now would be a notch down, $550 million-$600 million. Now, the biggest piece of that is actually currency. Because as you can imagine, given our headquarters in Switzerland, most of our corporate costs are in Swiss francs, and the Swiss franc also weakened with dollar. The corporate dollars, if you will, you know, will be a little bit less, and we will be a bit lower. If you take in constant currencies, where it's probably hard for you to model on corporate costs, right?
This year's quarter two costs were almost only $5 million lower than last year's quarter two costs. Of course, we do also work on corporate cost efficiencies. I think that answers the corporate part. In terms of the core costs and net financial results, we of course do have some income, right? We have some hedging gains, which is the other side of the currency impacts. That should also be a little bit lower. Of course, both of these list the C orporate costs are part of our core operating income guidance in constant currencies. A bit of gains on the net financial results, also those per year, but not so significant.
Thanks, Harry. Matthew, on the respiratory side of things, I think as you rightfully point out, we do have a business in inhaled respiratory LABA/LAMA/ICS outside of the US, primarily in Europe and to some extent in emerging markets. As well as we have the Xolair business outside the US in severe asthma, as well as as a co-promote in the US. All those businesses, you know, remain intact and of course, we'll continue to drive them. We always do evaluate, you know, what is the right mix in the markets.
I think with our recent announcement, where we moved to a single innovative medicines unit in every country that we operate in, we are going through an exercise to ask what is the right portfolio, not necessarily specific to respiratory, but what is the right portfolio of medicines for us to really focus our resources on, and where can we optimize or deprioritize so that we drive the most growth out of the business and really have the most impact that we can from the portfolio. As we get to better clarity on those decisions and if anything changes, we'll of course let you know.
Vas, I don't know if my mic's on. I don't know whether a follow-up's appropriate. Could we see those spun out with Sandoz, given that they'd fit with that kind of long life cycle ex-US footprint that Sandoz has?
I'm getting in trouble with all of my IR colleagues for taking your follow on, Matthew, but I will answer it since we've known each other for so long. Right now our intention is not to move any of our innovative medicines business with any consideration with Sandoz. We'll keep Sandoz as a pure play, small molecule generics and biosimilars business.
Thanks, and sorry Sir.
Thanks, Matthew. Next question, operator.
Thank you. Your next question comes from the line of Wimal Kapadia from Bernstein. Please go ahead. Your line is open.
Oh, great. Thank you very much for taking my question. Just firstly with Kisqali, you previously suggested that adjuvant is a $6 billion opportunity, but I'm just curious how we should think about it, because when you look at the epidemiology, it would suggest a much larger opportunity in the intermediate patient pool. I'm just curious what assumptions you're making in terms of which actually receive the drug in this population, because really, you know, if we see a decent penetration, the market potential should be significantly larger.
Just to be cheeky, 'cause we've done one round, just on sabatolimab, given the delay in filing due to needing phase 3 OS data, you know, and the high hopes that, you know, physicians seem to have for Venclexta and MDS from the VERONA trial, I'm just curious how you're thinking about the potential for the product in MDS at this point. Does it now become somewhat of a lower priority, or do you still believe that greater than $1 billion opportunity you discussed previously in MDS is still feasible? Thank you.
Yeah, thanks, Wimal. On Kisqali and the adjuvant setting, we do believe that with the possibility of adding intermediate risk on top of high risk, that is a significant expansion in the patient population, probably 3-4x what we see in the high-risk patient population. We previously guided to, I think, $6 billion based on what we saw and kind of consensus outlooks and various market projections. I mean, I would agree that if we are successful in demonstrating a meaningful benefit across that entire intermediate risk range, there could be a larger opportunity for the medicine. We're certainly doing that work now as we move towards the final readout of the study.
I agree, it is a significant opportunity and could be a fundamental inflection point for the company if Kisqali is successful. Most importantly, for all of those women with breast cancer who need better therapeutics so that their cancers don't recur. But I think it's a good push and we'll try to come back with better numbers. On sabatolimab, I think the data that we have suggests that we need to wait for the OS data in phase 3. The opportunity for this medicine is both across AML and MDS. We do note that there is a rapidly changing treatment landscape in MDS.
Nonetheless, we think that if the medicine has a unique mechanism of action with targeting TIM-3 and could be used in combination with other agents, and if the safety profile were to reasonably hold up, we do think it has that billion-dollar potential in each of the indications. I would note we need to wait now for the full phase 3 studies, and it wouldn't be prudent to put too much more onto it until we see that data readout.
Okay. Thanks, Vas.
Next, question, operator, and we'll try to do as many as we can in the last five minutes.
Thank you. Your next question comes from the line of Richard Parkes from BNP Paribas. Please go ahead. Your line is open.
Hi. Thanks very much for taking my question. It's a follow-up on Leqvio in the U.S. Feedback we've received recently from U.S. physicians is that they're still seeing difficulties accessing injection centers and that reimbursement's still challenging. I just wondered whether that's just an issue of experience and lack of infrastructure or whether there are other barriers that payers are putting into place in order to manage utilization, such as requirements for specific injection centers or anything you haven't seen?
Expected. Can I just ask a clarification? Because I think I heard you say that the final NATALEE readout was the end of next year, but I might have misheard that. Could I just clarify that timeline?
Yeah.
Thank you.
Yeah, absolutely. First on Kisqali, on NATALEE, it would be in the second half of next year, which I think is what we guided to previously, not end. I didn't mean to give a new timeline. Timeline is exactly as we've said previously, so no change in timeline. On Leqvio, I think there is an element of experience and also understanding the, you know, Part D and the payer dynamic. There is 30%-40% of patients who are in Medicare Part D, fee-for-service that don't have any relevant blocks and can access the medicines. There are sets of patients where there is a prior authorization, and then there's a set of patients that do have a step edit.
I think physicians are just getting experience seeing how you know, different patients actually have to move through the system. I think as they get smarter about that and understand those dynamics, as offices get better and as we get better at supporting offices, we should be able to overcome those. As I noted, we have a very high percentage of patients covered now to the full Leqvio label. To my knowledge, there's no restrictions on which alternative injection centers or other administration centers that can be used that would really be impacting that perception.
I think it's just if you happen to put a certain patient on a certain insurance as the first patient through the system, you do have to work through the reimbursement hurdles and get that all set up in the office. Normal things for a U.S. healthcare launch in cardiovascular, things that we're well adept at managing, having successfully launched Entresto, and things we're working very hard to resolve as quickly as possible. Next question, operator.
Perfect. Thank you.
Thank you. Your next question comes from the line of Richard Vosser from J.P. Morgan. Please go ahead. Your line is open.
Hi. Thanks for the follow-up. Just one on the LOEs that we should expect in 2023. I think Promacta is slated that there are some formulation and use patents that might actually push that out. Maybe similarly, just anything else like Lucentis that we should be thinking about. Thanks very much.
Yeah, thanks, Richard. Yeah, on Promacta, we're continuing to work to really support all the full range of patents we have on the medicine. I think, in an appropriate time, you know, if we're successful, we'll provide an update on Promacta. But it is something we're very focused on. Then on Lucentis, you know, we do expect the biosimilar, a few biosimilar entries in Europe. I think it's important to note that with the broad scale availability of Avastin for now many years, that we believe the biosimilars market has in effect already happened in Europe. We would expect a moderate decline on the launch of the biosimilars, but maybe not what you would see with other biologics when biosimilar entry occurs.
That's how we're forecasting Lucentis now for the coming years. One last question, operator.
Thank you. Your final question comes from the line of Graham Parry from Bank of America. Please go ahead. Your line is open.
Great. Thanks.
Yeah.
Jake, my follow-up. It was one on Gilenya. Obviously you've had the overturning the decision from the appeal court, and you said you're going to petition. Just help us understand timeframe for the petition. Does that prevent a launch happening in the intervening timeframe? Your level of confidence that we won't see a launch this year, or is the guidance just a guidance assumption but that could change depending on what happens with the court? Then just one last one. Kisqali growth was just well above prescription growth, although obviously we are seeing resurgence there.
Is that reflective of real volume growth, or could it be just a sort of prescription retail versus the other channels that we're seeing, and actually the reported growth is much more in line with the real volume growth? Thank you.
On Gilenya, Graham, right now, no generics can enter the market. We are petitioning the court, and we would expect to get a response from the court in the coming months. If granted, then it would be another set of months before the hearing, and then the hearing would take another set of months. As a reminder, we guided to generics entering in 2024. Really what we look at here is between now and that timeline, when exactly the entry might happen. We'll know more, I think, as the court gives us feedback once we are in the process of submitting the petition. The petition would then need to be reviewed.
We'd either be rejected at that point or the petition would be granted, and then we would move forward from there. That's kind of the scenarios right now on Gilenya. To remind, again, the long stop date was anyway in 2024. From a midterm growth standpoint, this is not having a significant bearing. Also in Europe, where we were granted a patent by the European Patent Office, we expect that patent to be issued later this year, and we'll continue to defend Gilenya across Europe. A lot of things, puts and takes, I think on Gilenya at the moment.
I think on your question on Kisqali, I don't know the answer, so we'll just have to follow up with you, but we'll get back to you on that to make sure you're clear on the volume price dynamics. I would say that what we see in our numbers is a strong growth and underlying demand for Kisqali that we'd like to sustain. Thanks everyone for joining the call. Apologies we didn't get to every single question, but I really appreciate everyone taking the time, and we'll look forward to catching up soon. Bye-bye.
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