Earnings Call Transcript - AZN Q4 2024

Pascal Soriot, CEO

Thank you, Andy. Welcome everybody. It's great to see you all here today. Next slide please. 2024 was a very strong year for our company, I would say a very, very amazing year, I have to say, with total revenue up 21% and a core EPS up 19% as you can see here, a clear illustration of the strong underlying momentum of our company. I've also listed here 14% on core OpEx to show that we continue to work on leverage with a lower growth of our expenses relative to the growth of our total revenue. We also delivered important pipeline advancements with nine high value pivotal trials readouts in 2024. Combined, these trials represent over $5 billion in non-risk adjusted peak year revenue. We had, of course, more readouts than those nine, but those are the most high value readouts we had last year. At our Investor Day in May, we communicated our ambition to deliver 20 new medicines by 2030 and I'm pleased to report that we have eight new medicines approved to date, including the recent approval of Datroway, which was previously called Dato-DXD earlier this year. So if you move to the next slide, we continue to benefit from our broad based diverse portfolio of products and diverse geography and we have strong growth across all our therapy areas as you can see here and our key geographies in 2024. In the year ahead, we anticipate sustained demand for our innovative medicines and growth across geographies. In our results announcement, we provided an update on ongoing investigations in China. We've received a notification from the Shenzhen City Customs Office regarding suspected unpaid importation taxes totaling $900,000, which to the best of our knowledge relates to Imfinzi and Imjudo. So if actually AstraZeneca was found liable, a fine of between one to five times the amount of avoided import duties could have to be paid by AstraZeneca. We are continuing to cooperate with the government towards resolution of those investigations. I'm pleased to have Iskra, we call her Super Iskra, joining us today in her new role as Head of International. I would now like to invite Iskra to share early perspectives on her new roles and in particular China. Over to you Iskra.

Iskra Reic, Head of International

Thank you, Pascal. No pressure with the nickname. I'm very honored to have assumed responsibilities in the international region that as you all know combines China, emerging markets as well as Australia and New Zealand. Initially, when I started in my new role, my focus was really in how best to support our colleagues in China at the unsettling time for them. And I have been really truly impressed by their continued effort and passion to deliver on the values and our purpose and I have a real strong confidence in the leadership that we have in place in China. China revenues last year had increased by 15% throughout the first nine months and overall 2024 growth is 11% because of the quarter four decline of 3%. It is very important to note that that decline was primarily driven by year-end hospital ordering dynamics which affected a few products, specifically Tagrisso and Farxiga as well as demand for our respiratory products that is lower given the mild start of the winter. And while we do expect some headwinds specifically driven by VVP inclusion for our several medicines, we do expect the growth in China will continue and especially in the longer term where we see a strong opportunity and we are fully committed to continue growing in China. If I think about the emerging markets more broadly, I think you all know that we have been building our presence and capabilities for many years, accelerating our regulatory approvals and also doing our best to broaden our equitable access and we have seen strong growth over the past several years and we do expect that growth to continue. In 2024, overall emerging market growth was at 22%. The unmet need across the emerging markets is unprecedented or enormous. I mean if you look at any therapy area, but specifically if you look at the areas where we work, just to give you one example, in emerging markets, it's estimated that 1.8 million people will be diagnosed with lung cancer that represents actually 70% of the overall lung cancer diagnosis globally. The substantial unmet need, coupled with the increased investment in the healthcare as well as increased willingness to pay for the healthcare, gives us an opportunity to deliver and sustain and significant growth going forward. Thank you. Please advance to the next slide and I will give the floor back to Pascal.

Pascal Soriot, CEO

Thank you, Iskra. So as you heard from Iskra, there are enormous opportunities in the emerging markets, not only in China, but also outside of China and Iskra knows the region very well. So we'll definitely have a big impact on our future growth and we look forward to resolving the issues that we've been facing in China, of course. 2025 marks the beginning of an unprecedented catalyst-rich period for our company. We have talked about it before. We're looking forward to the results of high value trial readouts this year for several of our existing medicines including in HER2, Datroway, Imfinzi, Breztri and Fasenra. And importantly, we also anticipate the first Phase 3 data for seven enemies, including camizestrant and baxdrostat, two medicines which each have a potential to generate more than $5 billion in peak revenue. The value of our pipeline has been increasing steadily and, as I had not communicated earlier this year, we now have more than 90 late-stage trials underway with an average non-risk adjusted peak year revenue per trial of $1 billion. Looking only at the anticipated readouts in 2025 shown here, taken together this represents over $15 billion in non-risk adjusted peak year revenue potential. And that's why we have said a few times, by the end of this year, early 2026, everybody will have a good sense as to our chances to get to the $80 billion. You'll see the momentum that we have in our company plus you will see the outcomes of those trials. With that, please advance to the next slide and we'll hand over to Aradhana, who will take you through our financials.

Aradhana Sarin, CFO

Thank you, Pascal, and good morning everyone. As usual, I will start with our reported P&L. Next slide please. As Pascal highlighted, our company delivered very strong performance in 2024. Total revenue grew by 25% in the fourth quarter with full year revenues up 21% exceeding our twice updated guidance range of high teens percentage increase. Product sales grew by 19% in the full year driven by strong underlying demand for our medicines across regions. Alliance revenue increased by 55% reflecting growing demand for HER2 and Tezspire in regions where our partners book product sales. Collaboration revenue increased by 54% driven primarily by a $600 million Lynparza sales milestone recognized in the fourth quarter as well as smaller sales milestones for Beyfortus and Koselugo. Next slide please. This is our core P&L. Our core product sales gross margin in 2024 was 81.2% in line with our indication for a slight decrease compared to full year 2023. Core operating expense increased by 14% in 2024, well below the top-line growth of 21%. Core R&D expense increased by 19% and consistent with our prior commentary, as a percentage of total revenue, core R&D expense was towards the upper end of the low 20s percentage range. This increase supported multiple new trial starts, including Phase 2 trial starts for our weight management portfolio and the acceleration of our cell therapy programs. It also reflects costs following the closure of several business development transactions in 2024. Core SG&A costs increased by 11% reflecting continued investments behind launching brands. SG&A decreased to 28% of total revenue on a full year basis. Other operating income declined significantly as we booked more than $700 million in 2023 relating to the update of the contractual agreement on Beyfortus, as well as $250 million relating to the U.S. divestment of Pulmicort. Core EPS of $8.21 represents 19% growth placing us at the top end of our full year guidance. Next slide please. Our net cash flow from operating activities increased by $1.5 billion in 2024. CapEx of $2.2 billion was broadly in line with the indication of a 50% projected increase over 2023. This includes both tangible and software related intangible assets. We completed a number of business development transactions in 2024 including the acquisition of Amolyt, Icosavax and Fusion and incurred total debt payments close to $7 billion. We anticipate deal payments relating to past transactions of approximately $3 billion in 2025. Net debt increased by $2.1 billion to $24.6 billion, which is a level we are comfortable with. Given the growth in our EBITDA, our current net debt-to-EBITDA ratio stands at 1.5 times. We increased the full year 2024 dividend to $3.10 per share and announced this morning that we intend to increase our full year 2025 dividend to $3.20. Today, we issued guidance for 2025 and expect total revenue to increase by a high single-digit percentage and core EPS to increase by low double-digit percentage. We anticipate our strong growth momentum to continue in 2025, more than offsetting the headwinds that we have previously indicated. These dynamics also adversely impact our product sales growth margin, and we anticipate an incremental 70 basis points decline driven by the net effect of the IRA in the U.S., the anticipated inclusion in VBP of Farxiga, Lynparza in China, as well as the growth of our partnered products that have lower gross margins. Operating leverage remains a priority for our company. We continue to anticipate SG&A costs to grow at a slower pace than revenue. We are beginning to see benefits from the redeployment of our global footprint and continue to optimize our commercial investments across key disease areas to support new launches. R&D expenses are expected to remain in the low 20s percentage range of total revenue. Our full year guidance is, as usual, at constant exchange rates. Based on average January 2025 rates, we anticipate a low single-digit adverse FX impact on total revenue and a mid-single-digit adverse impact on core EPS. The recent strengthening of the U.S. dollar also affects our core operating margin percentage, and we estimate an adverse impact of roughly 20 basis points in 2025 based on average January 2025 FX rates compared to average rates for full year 2024 and roughly 50 basis points as compared to average FX rates in the first quarter 2024.

Dave Fredrickson, EVP, Oncology

Thank you very much, Aradhana. Next slide, please. So in 2024, Oncology delivered total revenues of $22.4 billion, which was an impressive increase of 24% with key medicines surpassing new multi-blockbuster milestones with Tagrisso achieving over $6.5 billion; Lynparza over $3 billion in product sales; Imfinzi and Imjudo combined approaching $5 billion; Calquence and Enhertu achieving over $2 billion in full year revenues, respectively. This strong growth really does signal clear progress on our mission to deliver medicines with the potential to transform outcomes for patients globally. Turning now to fourth quarter performance for our key medicines, Tagrisso global revenues grew 21% reflecting strong growth across all indications, partly offset by the customary fourth quarter hospital ordering dynamics that you heard about earlier in China. In the frontline setting, Tagrisso achieved over 75% market share globally, with close to 85% market share in the U.S. We continue to make steady gains in the adjuvant setting with ADAURA and saw encouraging early launch uptake for LAURA in early-stage unresectable lung cancer. Calquence total revenues increased 20% in the fourth quarter driven by sustained BTK inhibitor leadership in the frontline CLL setting and contingent expansion in the face of pretty fierce competition. In the fourth quarter, Imfinzi and Imjudo delivered 18% and 28% growth, respectively, and continued demand across lung and liver cancer in the U.S., as well as accelerating adoption of TOPAZ and HIMALAYA in Europe. As expected, we saw continued impact on established rest of world revenues following the two mandatory price reductions in Japan that took effect in 2024. Lynparza achieved global sales of over $3 billion in 2024, triggering receipt of a $600 million milestone payment in the fourth quarter, which was recorded in collaboration revenue. As the established standard-of-care across HER2-positive and HER2 low metastatic breast cancer, Enhertu delivered total revenue growth of 54% in the fourth quarter, partly offset by compensation following recent NRDL listings in China for DESTINY-Breast03 and DESTINY-Breast04. Last week, we received FDA approval and NCCN guideline inclusion for DESTINY-Breast06, which will further drive adoption in the ultralow setting. Truqap delivered $163 million in fourth quarter revenues, which partially benefited from stocking following the launch of the blister packs in the U.S. And I’m pleased to report Truqap is now a market leader in the second line, biomarker-altered, patient population. We received a number of landmark regulatory approvals since third quarter results, including U.S. and Japan approvals for Datroway, in HR-positive HER2-negative breast cancer; U.S. approval for Calquence in mantle cell lymphoma; Imfinzi and limited-stage small cell lung cancer; and European approval for Tagrisso in early-stage unresectable lung cancer. And finally, we received priority review designations for Datroway and late-line EGFR-positive lung cancer based on the TROPION-Lung05 study; and Imfinzi and muscle invasive bladder cancer, signaling the potential value of our rapidly advancing oncology pipeline.

Susan Galbraith, EVP, Oncology R&D

Thank you, Dave. So 2025 is shaping up to be a very exciting year across our Oncology pipeline. We look to maximize the reach of our innovative medicines across lung, breast, GI, and bladder cancers and present additional data for some of our transformative technologies, including our I/O bispecifics, ADCs, and T-cell engagers. In the second half of 2025, we plan to announce the high-level results from the Phase 3 AVANZAR study of Datroway in combination with Imfinzi and platinum chemotherapy in patients with first-line non-small cell lung cancer. AVANZAR will be the first of five Phase 3 trials in frontline non-small cell lung cancer to read out and has the potential to not only confirm combination efficacy with I-O but also serve as the first prospective validation of the TROP2 QCS NMR biomarker. Importantly, we recently amended the primary endpoint to focus on the non-squamous population and to look at the benefit in both TROP2-positive non-squamous and the broader non-squamous population, which we believe increases the probability of the trial's success. Additionally, we expect results from the TROP2-Breast02 trial of Datroway in triple-negative breast cancer in the first half of this year. In 2025, Enhertu will move into earlier lines of treatment of HER2-positive breast cancer. DESTINY-Breast09 aims to bring Enhertu to the first-line metastatic setting with both monotherapy and pertuzumab combination options. DESTINY-Breast05 and 11 are the first two readouts for Enhertu in the early breast cancer setting, where the opportunity for cure is even higher. Our Imfinzi bladder and gastric programs continue to advance with readouts for VOLGA, which builds on NIAGARA, the combination of enfortumab vedotin and Imfinzi plus minus Imjudo in patients with muscle-invasive bladder cancer with POTOMAC in non-muscle invasive bladder cancer and with MATTERHORN in gastric cancer. Together, these trials represent meaningful new opportunities for Datroway, Enhertu and Imfinzi as we look to expand the reach of these transformative medicines.

Ruud Dobber, EVP, BioPharmaceuticals

Thank you so much, Susan. Our BioPharmaceuticals medicine saw another very strong year of performance in 2024 with total revenue growing 21% to $21.9 billion. In the fourth quarter, BioPharmaceuticals growth was 24%. R&I grew by 28%, an impressive performance despite softer demand in China due to a mild start to the winter season for respiratory viruses. CVRM grew 17% with strong Farxiga growth of 22%, which was partly offset by year-end hospital budget dynamics in China. Alongside Fasenra and Symbicort, Tezspire became the third blockbuster medicine in our respiratory portfolio with over $1 billion in combined global end market sales. Soon, we can expect to see a fourth blockbuster on that list as Breztri delivered over $0.25 billion in revenue in the fourth quarter. Given strong global demand and increased production capacity for Beyfortus, we recorded a sales-related milestone payment of $111 million in the fourth quarter. The launch of Wainua in ATTR polyneuropathy is progressing very well. And we are excited about the longer term opportunity in the broader ATTR cardiomyopathy indication. And following the commercial launch of Airsupra early last year, we have seen impressive volume growth, and we continue to work on broadening the access for patients.

Marc Dunoyer, EVP, Rare Diseases

Thank you, Sharon, and next slide, please. The rare disease delivered total revenue of $8.8 billion in 2024, up 16% year-over-year driven by increased patient demand and launches in new markets. Total revenue growth included a 2% benefit from a sales milestone for Koselugo received in the fourth quarter. In the quarter, Ultomiris grew 33% driven by neurology indications, with the vast majority of growth coming from generalized myasthenia gravis patients who are naïve to branded treatments. Outside of emerging markets, Soliris revenue continued to decline due to the successful conversion to Ultomiris, some competition and in Europe, biosimilar pressure. As a reminder, we expect biosimilars to enter the U.S. market in March of this year. Beyond the complement, Strensiq and Koselugo grew 37% and 97%, respectively, driven by continued patient demand, new launches and favorable tender timing in emerging markets. 2024 was another year of double-digit growth for rare disease medicine, and we see momentum continuing in 2025.

Pascal Soriot, CEO

Thank you, Marc, and I will try to conclude quickly, so we can move to the Q&A session. Next slide, please. So as you can see here, we are making a very important step toward the achievement of our strategic ambitions, in particular, the $80 billion sales in 2030. And we are progressing high-value readouts that will unlock further growth. So if we move to the next slide, this is an important slide because it really shows that the investments we are making. And of course, those investments create R&D budget expansion, but those are investments that are not only supporting the growth of our existing and late-stage portfolio, but we’re also building capabilities and capacity with potentially transformative technologies shown here. Our goal is to be a growth company until 2030 but also beyond 2030 and anticipate today what will shape the future of medicine and how we will actually continue to grow despite patent expiries that may happen post 2030. And with this, I’m really pleased to report that we’re making very good progress in all of these areas with multiple pivotal trials planned or initiated for our ADCs, our bispecifics, and most recently, our CAR-T NRT cell engager programs. These transformative technologies have the potential to drive sustained growth beyond 2030. Next slide, please. We continue to make progress, against all the ambitions outlined at our Investor Day in May 2024. We set our sights on $80 billion in total revenue by 2030, as we communicated at the Investor Day. By the end of this year, early 2026 latest, we’ll have a very good idea as to whether this ambition can be achieved. We’re working hard to drive operating leverage throughout our company, and we continue to make good progress towards achieving our ambition for mid-30s operating margin in 2026. And finally, and most importantly, we have actually delivered eight new medicines toward our goal of 20 by 2030, and that demonstrate our ability as a team to deliver life-changing medicines for patients globally. Please move to the next slide.

James Gordon, Analyst, JPMorgan

Thanks for taking the question. I’ll stick to one theme which will be China. So a couple of questions on China. So one would be – so revenue is down 3% in Q4. But how did it evolve during the quarter? So what did it look like before there was the investigation on November 5 versus afterwards? And more recently, like the start of this year, are things getting better or worse in China? Also in China, the 2025 guidance, so you've given us a group guide, but what does that assume for China? And I can see we've got Lynparza and probably Farxiga VBP. So should we assume that China is going to decline overall, not just because of the investigation but also VBP, but EM overall still grows, how to think about that? And then just finally, on China, I think there've been investigations going for some time but I've not seen any provision for a fine or other penalty in your disclosures. So how should we read that? Does that – you don't think there is likelihood that you're going to have to pay something material? Or is it just that you wouldn’t provision for it at this time? When would you have to have a provision for something?

Pascal Soriot, CEO

Thank you, James. So let me start with the last question, and then for the business development and business growth, I'll ask Iskra to comment and maybe Aradhana to take the guidance question. So we actually disclosed things as we learn about this investigation. An important piece is that we disclose anything that we believe will have a potential liability dimension. We disclosed this in our release. I would like to refer you to this and look at it. So if you look at these things in turn, first of all, the illegal importation. We've communicated $0.9 million of avoided import duties. To the best of our ability – to the best of our knowledge, as we said, it relates to Imfinzi and Imjudo, the fine that could be associated with that if AstraZeneca is found liable for it would be 1 to 5 times the amount of avoided import duties, so 5 times – maximum 5 times the $0.9 million. Now it is possible that Enhertu, for instance, will be affected as well because those products – the products that are affected essentially products that were approved in Hong Kong, not yet approved on the Mainland. And there's a limited period of time during which patients actually can totally, legally go to Hong Kong and get their medicines. But of course, some people found the opportunity here to take this product from Hong Kong and deliver them to the patients on the Mainland, and that is illegal. Patients can go, get their medicines. Other people are not allowed to do the transportation, if you want, of those medicines to patients. So we know Enhertu, of course, had a period of time when it was approved in Hong Kong, not on the Mainland. So that could be another one. But again, the turnover associated with Enhertu is a bit bigger than Imfinzi. But it's not going to be massively bigger. So that's the illegal importation case. And that's basically what we know in terms of the so-called fraud case. Again, I just like to remind you, we disclose in the litigation section anything that could have liability dimension for the company. Now some of you would like to, I'm sure understand better the sort of individual responsibility, corporate responsibility, legal aspects as it relates to fraud cases like this. My best advice is to suggest that you contact one of the magic so-called firms here in London, make sure you – to get advice, independent advice from them. Make sure you ask a firm that has an affiliate in China, our partner in China that has a license to comment on Chinese laws. Because global firms are not allowed to comment on Chinese law. So if you want a precise, reliable answer, you have to get it from someone who has a license in China. So ask them and you'll get, I believe, a very clear answer to that question. And that's really the most we can actually talk about this case.

Iskra Reic, Head of International

Yes. Thanks, Pascal. So thanks for the question. So I think the – as Pascal mentioned, I mean, there is not much to read in the dynamic of the quarter four, because it's really – you will see the same trend in the respiratory products given the mild winter. And it's interesting to look at because it's – because of the mild winter, clearly you have a lower level of the flu infection that drives lower rate of the hospitalization. And particularly in China, those products, Pulmicort in particular, are really used for hospitalization and exacerbation. And if you look at the overall inhaled market, you will also see the significant slowdown in growth. Quarter four growth of the inhaled market was 9% versus 23% in quarter three. So I would argue that's a very clear dynamic that you can see throughout the quarter. As you know, the winter is back and the flu infections in China are quite up. So you would you would argue that you may expect the respiratory portfolio performing as expected as normal in the quarter one. I think the second mentioned dynamic was the hospital capping. And I think it's – you see the similar trend, I would argue, the same trend as you saw for the top 10 brands in the – listed in the hospitals in China. The only difference is that this year, that effect was a bit bigger because more hospitals were introducing the hospital capping, trying to manage their budgets and the pressure at the end of the year. But overall, it's looking, in 2025, obviously, early days. But you do expect the portfolio to continue to grow. We have a few good news in the year we can hear to being included in NRDL with the eight other renewals in an NRDL and regulatory approval of the two new indications for Tagrisso and Lynparza. So despite the headwinds that we expect from the VBP inclusion in Farxiga, Lynparza and roxadustat, we do expect the rest of the portfolio to continue to grow.

Pascal Soriot, CEO

The biggest headwind really is VBP in 2025. Iskra, maybe you wanted to say a little bit about the team, where they are at. I think it's important to get a sense for potential momentum into 2025 but also our interactions with the medical community in China.

Iskra Reic, Head of International

Yes. I just spent four, five weeks in Shanghai, and I was really impressed on one side, as I mentioned in my remarks, on the commitment and – of the team. Equally, I was impressed that – it was unsettling moment in November and December, but I was really impressed how – with the stability that we introduced in December and the clear focus on what the team needs to do, that both team in the office and on the ground are very much focused and keen to continue doing what we do best, and that is delivering our innovative medicines to the patients in China. And I think the message of the company commitment and our belief that our strategy in China is the right one that we believe in the – in our ability to deliver for patients, but equally to use a growing innovation in China for China and for global is very much – landed very well internally as well as externally. I think from my external interactions with many different stakeholders there. I think it's also clear that our partners and stakeholders in China are willing and happy that we will continue to invest and partner with them in order to bring innovations together.

Aradhana Sarin, CFO

Sure. So on the guidance, obviously, China is included in our guidance, we do assume growth from our underlying brands as well as the NRDL other inclusions that Iskra talked about. But at the same time, there is headwind from VBP, again, three large products obviously being included in VBP this year, as well as some disruption from some of the ongoing investigation and team stability and so forth.

Luisa Hector, Analyst, Berenberg

Thank you. I have just one more on China and then some on the outlook. So for China, can you then confirm if there have been no notable changes in your market share for key drugs in China? And then for the outlook, perhaps just to quantify, if you can, the Part D impact for 2025 redesign. I think I only heard mention of Calquence from Dave, but perhaps other products to be aware of. And Aradhana, you mentioned $3 billion of deal-related payments. I’m just curious whether you can provide any color on the components. And should we assume that the majority of those come essentially with success, so pipeline success, sales success? Thank you.

Pascal Soriot, CEO

Thank you, Luisa. I can see that I’m totally failing once more, three questions at the time. So should we start, Iskra, with you and then Dave, you cover...

Iskra Reic, Head of International

So quick response in the market share. As I mentioned, the inhale market is – I mean, the whole market obviously slowed down. So clearly, you will not see any major difference in market share. With Farxiga, you will see some difference and there is some decline in the end of the year. And the reason is that the hospital capping that I mentioned really applies only for the 10 top performing brands. Clearly, as you know, Farxiga is competing with many different SGLT2 generics in the China market. So in December, due to the capping, you will see some decline. We saw the same trend, as I mentioned last year, and you would expect that to bounce back.

Pascal Soriot, CEO

But net-net for important products like Tagrisso, etc., so far, we have seen no impact. Of course, we looked at that because market share is the best way to actually assess whether you’re impacted. I mean, the market moves up and down, we see no impact at all, yes. Early days and so far, we only have hospital data. We need a retail data. It takes more time to get there. But it’s very encouraging to see our market share actually not moving differently from what we would expect. Dave you cover, Part D.

Dave Fredrickson, EVP, Oncology

Yes, please. So I think the first point we saw on Part D is that the IRA we’ve continually said we think is manageable, it’s part of guidance, it’s in our outlook. So why do we think it’s manageable? Well, first and foremost, it predominantly affects our oral oncology portfolio. There is some biopharmaceuticals and rare disease impact. But in terms of where we see the greatest impact it’s on oral oncolytics. There is a downside pressure of the increase manufacturer liability that now is happening in terms of picking up what was previously catastrophic. But there is a partial offset, and we saw that happening in 2004 from improved adherence and compliance on medicines and also lower free drug utilization. And that volume is directly a result of improved patient affordability. And so that’s the first dynamic for manageable. I think the second thing that’s most important here is that we just look at the growth opportunities that we’ve got in 2025, right? So Tagrisso, we have continued opportunities, ADAURA, LAURA, FLAURA2; Imfinzi, HIMALAYA, ADRIATIC, CASPIAN, NIAGARA; Enhertu, DB06, DB04, DB03; and Truqap. Those are all in hand. And so it allows us to be able to work through the headwind that we’re getting in from IRA and that’s why it’s included within our outlook.

Aradhana Sarin, CFO

So just to build on Dave’s point, the guidance, especially the gross margin guidance that I provided in terms of 60 to 70 basis points, that does include the net effect of the IRA. Again, we haven’t given an absolute quantification, but that as well as the PPP as well as some of the impact from biosimilars, that’s included in the gross margin indication. As it relates to the $3 billion for past deal-related payments, yes, most of them are success-based. But success could not necessarily be Phase 3. Some of them have already happened with Daiichi, for example, but it could also be progression events. So when the product moves into Phase 2 or into Phase 3, which is also success-based, because obviously, we want to move them into the next phase if we weren’t confident.

Pascal Soriot, CEO

Just since we talked about Part D, keep in mind that basically, the headwinds we have in 2025 are, of course, IRA, two is VBP China, we mentioned it. Another couple of smaller ones, Brilinta patent expiry and the usual maybe more intense this year cottage industry of price cuts and rebates and whatever in Europe. But the momentum in the portfolio and in the new indications we hope to launch, certainly will continue to support our growth and move through these challenges in 2025. There’s one last question on the table.

Jo Walton, Analyst, UBS

Thank you. A couple of clarifications, I think. Aradhana, I didn’t catch what you said about the gross margin impact for 2025. Could you just tell us again what you’re expecting to happen there? You spoke very quickly. And is that something that we should continue to see through into 2026 as well? Or is it just a one-time impact? And just to go back to Part D again, if we can. You say you – are you already seeing increased adherence. In 2024, the payment levels were lower but they aren’t as low as they’re going to be in 2025. So are you anticipating a further improvement in adherence? And is there any chance of things being even better in the first quarter because of the all you can eat buffet that you get – if you pay your $2,000 across the year rather than have to pay a big lump sum in January? So just whether we should be seeing anything in the short-term.

Aradhana Sarin, CFO

So I’ll address the gross margin one. So the indication is more around the – so I said 60 to 70 basis points impact on gross margins. And a lot of that comes from the Part Ds – the net effect of the Part D payments. If you want to think about it, again, it’s not a gross to net discount, but it does affect what you pay off of your revenue base, so that’s included there. When I say VBP, again, VBP when you get your price for VBP and their stock compensation and so forth, it affects your price, right? It doesn’t affect necessarily your volume. There’s some impact on volume. But you hope that once there’s a reset on volume, obviously, generic will take some share and then you’ll start going from there, which is what we’ve seen in other VBP situations. So again, that impacts your gross margin because your price is basically reset. I talked a little bit about – and Pascal said a whole bunch of other price actions which you see in Europe and other countries. Soliris biosimilar is another example, right, where we have been transitioning more and more of the market to Ultomiris. Again, Ultomiris is at a 30% lower price than Soliris is. As more market shifts to Ultomiris, again, it’s slightly different, slightly lower gross margins than Soliris. So it’s all of those factors that – and again, I don’t think they are one-time factors, but that’s sort of what we expect to continue.

Dave Fredrickson, EVP, Oncology

Yes, so I think the first point we saw on Part D is that the IRA we’ve continually said we think is manageable, it’s part of guidance, it’s in our outlook. So why do we think it’s manageable? Well, first and foremost, it predominantly affects our oral oncology portfolio. There is some biopharmaceuticals and rare disease impact. But in terms of where we see the greatest impact it’s on oral oncolytics. There is a downside pressure of the increase manufacturer liability that now is happening in terms of picking up what was previously catastrophic. But there is a partial offset, and we saw that happening in 2004 from improved adherence and compliance on medicines and also lower free drug utilization. And that volume is directly a result of improved patient affordability.

Pascal Soriot, CEO

Thank you. Let's move to another table.