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AstraZeneca PLC (AZN)

Q4 2019 Earnings Call· Fri, Feb 14, 2020

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Transcript

Pascal Soriot

Operator

Good morning, good afternoon, everybody. Hello, everyone. It’s Pascal Soriot, I’m the CEO of AstraZeneca. Welcome to the full year and the fourth quarter 2019 presentation, our conference call and our webcast for investors and analysts. We are live in London. As always, our presentation is available on astrazeneca.com, and we’ve also sent it to people on our distribution list. Please turn to Slide 2. This is the Safe Harbor statement. We’ll be making comments on our performance using core financial numbers and at constant exchange rate or CER, which are both non-GAAP measures. We’ll also discuss other non-GAAP measures deemed helpful for investors and analysts. For a reconciliation between non-GAAP and GAAP measures, please see the results announcement issued this morning. And finally, all numbers, as always, will refer to million U.S. dollars and growth rates will be at CER and for full year 2019 until – unless we state otherwise. Please turn to Slide 3. We plan to spend about 40, 45 minutes on the presentation, and we’ll stick to our text so that we don’t go over the time, so we have enough time for Q&A. [Operator Instructions] There’s also an option to ask questions as part of the webcast. Because we would like to provide everybody with an opportunity to ask questions, we would like to ask you to please limit yourself to one question, the first one. I know I ask this every time and I’m never successful, but let me try again. Today, I’m joined by the usual team, Dave Fredrickson, our EVP for Oncology; Ruud Dobber, our EVP for the BioPharmaceutical Business Unit; Marc, our CFO; José Baselga, who is the EVP in charge of Oncology R&D; and Mene Pangalos, our EVP in charge of BioPharmaceutical R&D. We also have with us from…

Dave Fredrickson

Analyst

So Thomas and the IR guys really put a lot of effort into this podium, so I thought that I would use it. It would be a shame to leave it here all by itself. So on Oncology. As we report on sales for Oncology, we reached sales of $8.7 billion. And as Pascal said, that was growth of 47%. And our four new medicines really were the contributors of $2.9 billion of incremental growth for the year. As anticipated, we experienced some softness in the final quarter of the year with our mature portfolio. So, we had Faslodex and generic competition enter into the United States. We also saw further competition for Iressa and cannibalization across the globe. And then some onetime effects, especially within the U.S. and within China, and we can talk more about that later. In the lung cancer franchise, the Tagrisso and Imfinzi launches in the approved indications have progressed as more countries outside of the U.S. have granted approval and reimbursement based upon FLAURA and on PACIFIC. Lynparza continued to cement itself as the leading PARP inhibitor. It became a blockbuster in 2019, as Pascal mentioned. And we saw more women with first-line ovarian cancer being treated across the globe as we establish a standard of care following on SOLO-1. With our mature medicines, Faslodex had sales of $892 million for the year. This was a decline of 11%. The impact of generics, as I mentioned, really taking hold in the fourth quarter, particularly within the U.S. On the other hand, and I think importantly, we saw growth in strength in Zoladex, really on the heels of emerging markets. Sales were $813 million for the year, up by 13%. Lastly, on the overview slide, in terms of the new launches, we were incredibly pleased,…

Ruud Dobber

Analyst

Thank you so much, Dave. For today, I’m very pleased to talk to you about the BioPharmaceutical business. Total sales of BioPharma, comprising new cardiovascular, renal and metabolism and respiratory were $9.8 billion in the year, growing at 13%. It has now been one year since the integration of the BioPharma business units, and we are pleased to have made strong progress across the board. We have achieved double-digit growth in New CVRM and respiratory as our new medicines continued to thrive. Please turn to Slide 18. As you see here, we are very pleased with the continued growth of Farxiga and Brilinta, the ongoing successful launch of Fasenra and the recent launch of Breztri in Japan. In the established respiratory business, Symbicort and Pulmicort delivered encouraging performances and continue to grow. We look to build on this overall growth in 2020, including further launches of Lokelma, and later in the year for roxadustat. Please turn to Slide 19. Moving to New CVRM, sales were up by 12% despite intense competition in diabetes, with total sales of $4.4 billion. Growth for both Farxiga and Brilinta continued with double-digit increases globally. Farxiga delivered sales of $1.5 billion, with 14% growth, maintaining volume market leadership globally, while benefiting from the SGLT2 class growth. In the U.S., Farxiga saw a reduction of 9% as price declines took effect, though volumes continue to grow. Outside the U.S., which accounts for 65% of sales, we saw very encouraging performances with volume-driven growth increasing. European sales were up 25% driven by the DECLARE cardiovascular output data, and emerging market sales were up by 48%. Bydureon sales were down by 5% at $549 million. We returned to growth in the last quarter following the impact of production constraints in the first half year for the Bydureon BCise…

Marc Dunoyer

Analyst

Thank you, Ruud, and hello, everyone. I want to take you through our financial performance in the year and the fourth quarter as well as our financial priorities and our guidance for 2020. But before I do that, I would like to provide a summary of our 2019 financial achievements. With the progress we are making, it is right to recognize the work of so many of our colleagues, we have achieved a great deal in this year. I’ve listed some examples on the slide. In finance, we have gone through a transformation program in the last two years. From a multiplicity of digital financial systems, we consolidated everything into one planning and reporting tool. Having a better grasp of the single source of tools was the first objective. We have also built new functionalities such as project accounting across the whole company. This new system enabled us to rapidly adjust to the organization changes such as the one we put in place in our R&D. Overall, the finance team can dedicate more time to support the alliances that we have set up with Merck, Daiichi Sankyo or FibroGen, for instance. On the front of new technologies, we have now 100 robots in use not only in finance, but across the whole company, in HR, medical, commercial and R&D. And we are learning to generate more value added from each robot. Please turn to Slide 26. Turning now to financial performance, I will start with the reported P&L before reviewing our core results. As Pascal mentioned earlier, product sales grew by 15% in the year, while around 75% of collaboration revenue comprise payments for Merck in respect of the success of Lynparza. In the future, a growing share of collaboration revenue will represent income from the sales of new medicine…

Mene Pangalos

Analyst

Thank you, José. Good afternoon, everyone. Happy Valentine’s Day. I hope you enjoy your chocolate treats again from our IR team. I’d like to start by reflecting on the synergies in our cardiovascular, renal and metabolism portfolio, and highlight the fact that our medicines often treat more than one aspect of a given disease. We continue to work on indications, including heart failure, chronic kidney disease, diabetes, myocardial infarction and NASH across the CVRM spectrum. For example, patients with chronic kidney disease often show deterioration in cardiac function, resulting in heart failure. Furthermore, as their kidney function continues to decline, patients face an increased risk of developing other complications, including anemia and hyperkalemia, both associated with increased hospitalization and mortality. By understanding the comorbidities across the CVRM spectrum, we can better position our molecules to improve both patient outcomes and quality of life as well as supporting health care systems globally. Please turn to Slide 37. I’ll now update you on our recent R&D progress made in the CVRM space. We are pleased with Farxiga as it moves beyond diabetes and into heart failure treatment with regulatory submissions for DAPA-HF completed in all major markets and priority review granted in the U.S. Brilinta saw the submission of the THEMIS data set in Japan and China in the period, and we also recently announced positive top line results for the THALES trial in stroke. In renal, Lokelma gained regulatory approval in China for the treatment of hyperkalemia. And roxadustat, HIF prolyl hydroxylase inhibitor for the treatment of anemia from CKD received regulatory submission acceptance in the U.S. by our collaborator, FibroGen. For roxadustat, following the positive high-level Phase III pooled analysis that we presented in May, FibroGen and AstraZeneca presented that efficacy at the American Society of Nephrology Kidney Week in…

Pascal Soriot

Operator

Thank you, Mene. So we have so much information to share. We’re a bit over time. So we’ll stop here and then go straight to Q&A. So we dedicate enough time for your questions because that’s really very much what we are here for. So who wants to get started? Andrew?

Q - Unidentified Analyst

Analyst

Thank you. First question for José. Your portfolio is very full, but perhaps some of the programs have not progressed as fast as one might have hoped. So when you’re thinking through the rate-limiting steps, obviously, you need data that you need to have the right team, sometimes that you have a partner, which can create complexity. Could you help us understand which of those, or resourcing even, explains why some of those drugs? And I guess I’m thinking historically of the AKT, the SERD, I mean, although you’re moving fast with the second generation, but it just seems the opportunities that exist to prosecute for some of these drugs are perhaps moving on a slower time line than maybe ideally what might have hoped. So that’s the first question. Second question, there’s talk about the GRASS fee bill coming back. Could you talk about the extent this is a negative in terms of intensifying pressure on pricing for drugs like Tagrisso as PBMs have more skin in the game in terms of catastrophic coverage and for Calquence? And then finally, on DAPA-HF, assuming you get approval, it seems very likely, what do you think would be the speed of uptake given that cardiologists are unfamiliar with this modality? How do you expect the growth rate of Farxiga to be transformed by DAPA? Thank you.

Pascal Soriot

Operator

So maybe, José, you could cover the first one. And then Ruud, you’ll cover the DAPA-HF ramp-up. And so I will say a few words on the GRASS fee bill as well. So go ahead. José Baselga: Yes. So let me answer to the first question, Andy, that had five questions on it. So I think what you said is absolutely right. When you have a very diverse pipeline with many, many assets there, you have – you’re facing a number of risks of perhaps not moving things forward as quickly as you could. I think a big solution to this has been to have a unified oncology R&D organization. And since last year, what we have seen is that we have moved three of the Capiva programs all into Phase III. So Capiva now is into Phase III. We are moving this year the SERD program into the late oncology group. So that’s already happening. And we’re beginning to see some programs such as the PD-1/CTLA-4 that has been has been accelerated in which, at the same time, the late oncology and the early oncology groups are co-developing the product. So what we are anticipating and what we will do is to improve in our process of prioritization. We have stopped a number of programs last year. And by the way, some of them were absolutely probably fine, but they were not top priority. We decided to accelerate six programs fast and those are moving very quickly. So I am very confident that this new R&D organization is enabling this kind of fast-forward decision-making process, and you will see that happening. The SERD is a fantastic example of that.

Pascal Soriot

Operator

Maybe the one thing I would add to this is – I mean José is absolutely right, and that’s one of the reasons why we realigned ourselves to be faster. But if Susan was here, Susan Galbraith, she would tell you on the SERD, we had, I mean, a couple of other agents that didn’t work that didn’t deliver what we were expecting. So we were refining until we get to – we got to the agent we have now, which we think is a good one. So that is also a factor. But it’s clear, we certainly, in some areas, could have been faster. One of the things we’ve done lately is we have three priorities. One is how do we deliver in the near term these launches and improving our profitability and our cash flow. Two is how do we accelerate, what are the projects in mid-stage development that we are accelerating, not only in oncology but outside oncology. And the third is really 2025 and the big trends in the industry, digital and other technologies, and where do we want to play to be a leader in 2025? So Ruud, do you want to cover DAPA and maybe say a few words about the GRASS initiative? I mean you – I suppose you’re referring to the Senate bill, right, or…?

Unidentified Analyst

Analyst

Yes, yes.

Ruud Dobber

Analyst

Yes. So first, a few words about the HF opportunity. I think it’s very substantial. You’ve all seen the results. We were granted priority review. So as an organization, we are very bullish about the potential. And equally, of course, it will take time for cardiologists in order – as you refer, Andrew, in order to embrace these products for – especially the non-diabetic patient population. What is helping us well at the moment is that guideline committees around the world are very progressive in order to include it in the guidelines. There’s a lot of initiatives ongoing in order to get that done. So all in all, we feel comfortable that this will be a very important growth driver. Specifically, in the United States, we have launched the DECLARE indication, which is the prevention of heart failure, only a few months ago. And clearly, at the level of the cardiologists, we – although the numbers, the absolute numbers are small, we see quite an impressive growth of that segment. So time will tell. But of course, we are very committed in order to make this a great success because of the huge benefits for patients in – with heart failure. And then finally, the Senate bill in itself, and we spoke about that a couple of times in the past, Andrew, and personally, I don’t think a lot has changed. Every week, every second week, there is a new level of speculation in the U.S. around this bill. There are a couple of elements of the bill. We clearly support the out of pocket – capping of the out-of-pocket cost clearly is something we can support. The impact, especially on our oncology products or Part D products like Calquence and Tagrisso can be, to some extent, substantial equally. It has also a couple of advantage for the BioPharma business. So as an organization, I think it’s a balanced impact for us at this stage. But I close by saying it’s far too early to speculate about what is really going to happen there.

Sachin Jain

Analyst

Sachin Jain, Bank of America. A question on guide and then a question on some launches. So while 2019 sales growth is very strong, some of the key product drivers missed and you’ve moved away from product sales growth, so there’s obviously some level of nervousness. I wonder if you can give some color around the revenue guide. What’s your level of comfort with product sales at roughly double-digit growth ex the China impact? Or is collaboration revenue a disproportionate driver of that total revenue growth? Then on China, have you seen any impact to date? And any color you can give as to what is assumed within the guidance from an EPS perspective, just to give some color. And then on launches, David, you mentioned positive early indicators for Calquence in first-line CLL and for Enhertu. Wondering if you can give some more color on that for both those products. Thanks.

Pascal Soriot

Operator

Let me just ask Marc to comment on guidance, but I just want to make sure there’s no doubt. There’s absolutely zero nervousness about product sales. The reason we have moved to total revenue is very simple, is we are – I mean we went through a period when driving top lines, new product sales was key, but we’re moving into a period where essentially our long-term strategy of collaboration is starting to have an impact. So we have revenue coming from Enhertu, from roxadustat from a number of – Lynparza, a number of collaborations. And we need to make sure this revenue is recognized in our total revenue. On top of it, on a very practical front, from a governance viewpoint, so our Remuneration Committee wants to have a single number that governance groups and shareholders can recognize. So we said, okay, we’re going to pick one single number, which should it be? We picked total revenue. So – but there is absolutely zero anxiety about product sales. Marc, do you want to…

Marc Dunoyer

Analyst

No. I mean, it’s absolutely correct. I think the two lines will, in fact, grow in unison. The growth rate will be very similar, whether you look at total revenue of product sales. But we had, as Pascal said, we had to define one variable that we would consider for our guidance, and we decided to take the most complete information on total revenues. But when you see the numbers, they are very, very similar.

Pascal Soriot

Operator

I would also add that, I mean, personally, historically, I thought revenues like Enhertu and others will be recognized in product sales, but accounting guidelines are such that basically, it’s recognized in revenue. But at the end of the day, these are product sales, right? And we want those revenue to be recognized. So it’s pretty simple. Dave, do you want to cover Enhertu?

Dave Fredrickson

Analyst

Sure. So Sachin, thanks for the question. Maybe a bit more depth on Calquence since we’ve had more time in the market on that one. With Calquence, we are really pleased with the launch. We look at the metric that’s most relevant as BTKi class new starts because that’s really where we think we’ve got the most opportunity to make impact. And BTKi has been well established in CLL. So we really look at how we’ve penetrate into that. December is the first full month where we’ve been able to see in 2019 the performance. And I think you’ve got to look at the composition. So first, we saw good growth in the new patient starts, and you all have the IQVIA data and can see what you see out of that. I think the part that we see that’s important is the composition of those starts. So in December, the composition of that starts, I would say, is about 40% to 50% is late line, which is good in the sense that we have an expectation that we are going to get ibrutinib-intolerant patients that are going to be switching and moving over, and that’s predominantly what this patient population is and we expect that to be part of the business for the long term. The balance of it, obviously, would have been naive patients, new to BTKi. As we look at the January data and recognizing it as sort of an early view into it, we’re seeing that the number of third-line patients within those new starts is coming down after a very significant increase in December. This is consistent also with what we saw in MCL, now that bolus or warehousing, depending upon the language, and that set of patients with latent dissatisfaction with the tolerability of their existing medicines switching over. And so I think that we’re encouraged to see that the naive patient population is growing in terms of new patient starts on Calquence, and we look forward to continuing to watch this trend. But all signs are quite positive there. Enhertu, just very quickly, we see early adoption taking place, early booking of sales coming through. Anecdotally, we’re getting very good receptivity from physicians. We’re getting into seeing accounts. We’re getting listed in EMRs rapidly. We’re seeing pharmacies open us up so that we sit on formulary. All of these things happen because physicians have interest in prescribing the drug. And when that happens, things start moving quickly. It’s too early to know how much of the sales that you’ve seen is inventory build versus demand, but we think that we’ve got some good positive indicators.

Pascal Soriot

Operator

Thanks. Your third question was China. Can you just rephrase it?

Sachin Jain

Analyst

Correct. Have you seen any impact today? And roughly, you’ve mentioned a few months within guidance. So how does that translate on the [indiscernible]? Any more color you can give?

Pascal Soriot

Operator

Right. I mean maybe what we could do is ask Leon to comment, generally speaking. He is on the ground, and I talk to him almost on a daily basis. But of course, he’s on the ground. So Leon, do you want to comment on coronavirus and the impact you’ve seen so far or you expect?

Leon Wang

Analyst

Yes. I think the – of course, a lot of media reports. But I think the situation outside Hubei and Wuhan, Hubei province is improving. I think we cannot speculate how long will this epidemic last. I think it will still be the next few months. Right now, the impact is mainly the – our salespeople cannot easily visit the hospital and access to the health care professional because doctors, especially some of the specialty, are focusing on fighting the epidemic. So I think all these disruptions are quite temporary. And patients now, really instead of visiting hospital, they go to pharmacy to refill prescription and also they go online to consult doctors and also to get their prescription refilled. So that – we see a trend of such. And while the impact is temporary, but I still would like you to focus on the positive side. I think AstraZeneca the most widely expanded coverage company by rural community, hospital, retail, we are number one in the emerging hospital. And we have a lot of NRDL reimbursement inclusion last year and new indication approval. And we have also four new product approval in 2019. And AstraZeneca is also very strong in digital promotion and retail pharmacy promotion and also online pharmacy collaboration. And today, we started the first prescription of Imfinzi patients in China. So even during the epidemic, everyone, logistics side, supply chain side and the operation, manufacturing and head office people and a lot of functions are already working, starting from already beginning of last week. So I think AstraZeneca is quite a resilient organization. The whole team is behind making sure employee is safe and also doctors are supported and the business interruption is minimized.

Pascal Soriot

Operator

Thank you.

Richard Parkes

Analyst

Richard Parkes from Deutsche Bank. Firstly, just a follow-up on Sachin’s question about some of the key products being slightly below expectations in the fourth quarter. I think if you look at consensus numbers, a lot of that was slightly slower, your traction in Europe. So could you just talk about your level of confidence in driving uptake in those territories? Is it just a factor of timing in terms of reimbursement? Or have you been facing more challenging access than expected? Maybe you could talk about what – are you having to give more price than anticipated, particularly things like Tagrisso where there’s already a price in the second-line setting? Second question, one of your competitors has been very vocal about the preferential PK characteristics of its PARP inhibitor in mice. I just wondered if you could comment on your view on the clinical relevance of those findings? And then third question, just on Enhertu and the ILD incidents. Obviously, I think most of us view that the instance of serious ILD cases is a key gating factor to earlier use of the drug and you’ve tightened up the risk management. Can you talk about to what degree you can back-test whether that’s working by looking at the overall ILD rate in the ongoing clinical program? I know a lot of that’s blinded, but I’m sure you can see unblinded incidence rates.

Pascal Soriot

Operator

That’s good. So let me just suggest that – Dave, you could cover the first question because probably, I guess what people have in mind is Tagrisso and Imfinzi in Q4. Outside of those two, I mean we had a one-off cost to net adjustment on Farxiga, but I think maybe the softness, if you want to call it this way, relate to Tagrisso and Imfinzi and nothing that we didn’t expect before. So the key question is, beyond the U.S., what happens outside of the U.S. So Dave, do you want to cover this one?

Dave Fredrickson

Analyst

Yes, sure. So maybe starting first with Tagrisso. And Richard, you asked a bit about Europe, but I think it’s worth starting on the U.S. and I think that, that’s an important starting point. So Tagrisso in the U.S., we have now established as standard of care with Tagrisso in the U.S. And owing to that now, we’ve got about 2/3 of all starts are on Tagrisso. So we really have now gotten to a point where the growth that we expect going forward on Tagrisso in the U.S. sequentially would be incremental growth. With that said, we did see incremental growth in the U.S. in terms of demand in the fourth quarter. You’ll recall, in the third quarter, I talked about the growth between Q2 and Q3, which was $50 million on Tagrisso in the U.S. that about half of that was inventory and gross to net. And we definitely saw that – we saw a drawdown in inventory and a readjustment to gross to net in Q4 that explains certainly some of that. But we had mid-single-digit demand growth from TRxs and from duration of therapy in Q4 on Tagrisso. And we expect that to continue on a fairly substantial base in the U.S. and Japan into next year. And then we’ve got the other 62 markets that are progressing along quite nicely with Tagrisso in terms of the reimbursement decisions. And that includes places like Korea, Taiwan, still here in the UK, markets that have substantial sales that are behind it. On Imfinzi, I think Imfinzi, again, as I mentioned in my comments, and I won’t repeat, I do think that we’re at a spot in the U.S. where we’ve gotten ourselves pretty well penetrated into that Stage III setting. As I look at the growth drivers for Imfinzi in 2020, really, it’s, ex U.S., continued opportunity to drive on PACIFIC. Keep in mind that 70% of the sales on Imfinzi today are in the U.S. I would say that the composition that we might expect is more like 60-40 or 55-45, if you take a look at the other brands. So it gives reason to believe that we have an opportunity to drive outside of the U.S. We just got approval in China. So – and Leon mentioned the first patient infused there. So that’s not even in the performance yet. And then, of course, in the U.S., CASPIAN is the most near-term priority review. We’re getting ready for launches on that in the first half. And I think that with competition likely being limited to just the Roche molecule and not having three competitors in the space, I think that’s also something that gives us some cause for optimism on our opportunity to grow there.

Pascal Soriot

Operator

Thanks, David. José, do you want to cover the PARP question, the preclinical data? And also the ILD Enhertu? José Baselga: Well, I don’t feel comfortable commenting on mice PK data published in Oncotarget, I don’t. But I do feel comfortable discussing the clinical data and I think that’s very important. If you look – and again, you need to be careful in comparing different trials. But if you look at the data that we achieved with PAOLA, in our PAOLA population, we achieved more than two years of progression-free survival in the first-line setting, and this is totally unprecedented. So I think that we can get tight on PKs and we can get tight on a number of measures such as HR, but at the end of the day, I think when a patient comes to your clinic, what you’re asking about is, how long will I have disease without coming back? And I think when you look at the absolute number, which is what matters to any patient and to any physician, the PAOLA data set is the strongest overall. A point that you cannot compare different studies is that, for example, when you look at our population in PAOLA that is HRD-proficient and we looked at the same population that was part of the PRIMA study. So we basically – we took our HRD-proficient patients that fulfill the criteria of the PRIMA population. We observed also tremendous benefit. So the PFS in the olaparib plus bevacizumab arm was 22 months, and it was 16 months on the bevacizumab arm alone. And this is a data set that was presented at the recent ASCO meeting. So I think we feel incredibly confident that olaparib is the best in class. We have the lower rate of discontinuation. We have an unprecedented clinical benefit in terms of duration. So this is the best-in-class agent that there is, and we feel very, very excited by it and looking forward to be able to offer these to patients as soon as possible.

Ruud Dobber

Analyst

And we have Marc here as well, if anyone wants questions afterwards on PARP.

Dave Fredrickson

Analyst

That – Marc is there. Yes, Marc, yes. Now on the Enhertu ILD, since May, we have not observed a single case – thank, God – of ILD Grade V in our studies of 5.4 milligrams. So – and we’re enrolling a lot of patients into the clinical trials. There’s no question that the fact that physicians are aware and patients are aware of ILD and that we have instituted real-time guidance on how to treat ILD is making a progress. We don’t have yet data on real time. We don’t have that, but we are looking at this. I think, to me, a very reassuring piece of information is that we are enrolling successfully patients into our post-PCR study, which is an early disease study, and enrollment is going well.

Pascal Soriot

Operator

Thanks, José. Let’s take an online question. Tim Anderson [Wolfe Research], Tim, do you want to go ahead?

Tim Anderson

Analyst

Thank you. A couple of questions, please. Tagrisso, just to clarify, I think in prepared remarks, I heard you say that you expect NRDL for first-line in China, which would imply approval of first-line in China, or I guess at least reimbursement opening up for the product. I’m referring to the Asian patient subset of FLAURA where OS didn’t hit. So are you saying that everything’s all clear there and you expect there’s not going to be any reimbursement hurdles? Second question, not an exciting product necessarily, but Pulmicort in China, we learned recently that, that is the biggest single drug in China of all drug companies, hitting $1 billion, still growing, yet it’s off-patent. You may have seen our research recently digging into how long this lasts for because a lot of generic companies are circling. It seems to us maybe you have a few years where there is no generic threat, there’s no VBP risk. Hoping you can tell us your internal expectations on timing for this potentially happening in China. How long will it continue to grow for? And then just last question. Tezepelumab, only a brief mention today. We get Phase III data reading out this year. Phase II data looked solid, especially in the noneosinophilic asthma. Your level of confidence in that program replicating, what was seen in Phase II?

Pascal Soriot

Operator

Thanks, Tim. Yes, tezepelumab, we didn’t talk much about, but as you can see, we had – as you saw, we have so much to share that we were hardly a bit over time anyway, even without talking about teze. So Tagrisso, let me call that quickly. We’ve never said it would be easier. Reimbursement is always a challenge. And in China, essentially, we will start this process this year. And if we were successful, the reimbursement would be next year. But we’ve always said moving into first line will be more challenging because, of course, you have more patients, more budget impact and that’s a challenge. So that’s basically all we could say about Tagrisso. Pulmicort, maybe Leon, if you want to comment on it because one of the things in this – with this pandemic, by the way – or epidemic, sorry, is that this is likely to push patients to use more home nebulization. So in that case, it sort of goes in our favor of diversifying the base of Pulmicort. Leon, do you want to say a few words about Pulmicort in China and your prospects there?

Leon Wang

Analyst

Yes. I think, Tim, it’s a very good question. I think Pulmicort is one of the biggest product in our China portfolio. It’s around 20% of our total business. And I think I cannot speculate on when the generic will come. And I think this is a nebulized product and that there is a special guidance being reviewed by China NMPA and CDE about the – what kind of quality standard, nebulized form of drug should reach before they can get approval as a generic. So I think we – first, we will see a generic coming. And then is when – that you have enough generic, there will be VBP. And then certainly is the generic needs to have enough capacity and continue consistent quality. It’s – actually, our quality standard is quite high, and we’ll be – we are quite confident about our capacity and quality standard. I think even though it might come at some time point, I think we are now focusing also a lot of Symbicort penetration – inhalation. So Symbicort is still having huge potential in China, and that we are launching mild asthma indication for Symbicort. And we now – last December, we get also approval for Breast03, the triple, getting to the huge COPD untapped potential. And the China government also included asthma and COPD recently into the chronic disease category, together with high blood pressure and the diabetes. So I think there are a lot of positives and Symbicort also getting to EDL category, together with Pulmicort, removing limitation. So I think in the Respiratory portfolio, we have also Bevespi getting approval in moderate COPD. So I think we have a lot of positives to push on the inhaled part of the business in order to mitigate this Pulmicort mid- to long-term risk. And also, we have a lot of other new exciting launch – new product launches like roxa, Lokelma also get approval. Roxa get not only approval but also reimbursement inclusion. So I think we have many more cards in hand in order to mitigate this risk. So we are ready.

Pascal Soriot

Operator

Excellent. Do you want to say a few words about teze, Mene?

Mene Pangalos

Analyst

Just sort of – I agree that the data was very strong in the Phase II study. And I think both internally and externally, when you speak to opinion leaders, we’re very excited about seeing the Phase III data. And if positive and if we’re able to repeat what we see in Phase II, have the opportunity to really broaden out beyond this disease in asthma, which I think is going to be tremendously exciting now that biologics is starting to take hold.

Pascal Soriot

Operator

But we have to wait.

Mene Pangalos

Analyst

Yes.

Pascal Soriot

Operator

One question in the room. Okay, yes. Can we get another mic there so we don’t spend too much time waiting for mics?

Keyur Parekh

Analyst

Keyur Parekh at Goldman Sachs. Two questions, please. First one, Pascal, in 2019, about 45% to 50% of your growth top line product sales came from China. As you think about 2020 and geographic spread or breadth of growth, how much of that high single, low double-digit growth are you anticipating kind of coming from China? That’s question number one. And then secondly, Marc, in your prepared remarks, you spoke about the other operating income continuing to be a significant part of your income statement in 2020 and beyond. From a quantity perspective, should we think of it as broadly being in line with 2019, above, below 2019? Any sense there would be helpful. Thank you.

Pascal Soriot

Operator

So Marc, do you want to cover the second question?

Marc Dunoyer

Analyst

Yes. So I think the – you saw in 2019 a very dramatic reduction in collaboration revenue, in the sum of collaboration revenue and other income. I wanted to be very transparent on the trend for 2020 and not have people believe that this trend of minus 25% every year was going to continue. This is why I indicated that we would still have other income in 2020 and also give you one illustration, one example, of why this is going to continue. For instance, when we recover the rights of brazikumab, which is a novel medicine that we had partnered out to Allergan, this product is coming back. And we will have to – we will receive basically complete funding for this development, but we have to book it somewhere and we will book it as other income. So the line of other income is not only disposal. They will be including disposal, but also income on the deal, for instance, at the IL-23. Just to provide some context on the sum of collaboration revenue and other income, you were asking whether it would be in line. I think it’s going to be in line, not materially different from what you saw in 2019.

Pascal Soriot

Operator

And your first question. Essentially, we’ve guided on top line growth being high single digit to low double digit. We’ve said that our emerging market will be low double-digit growth, and China leads the pack typically. So it’s going to be higher than this. I’ll just let – leave it to you to do the math of how much China can represent of our total growth, but it will remain an important part of our sales growth.

Mark Purcell

Analyst

It’s Mark Purcell from Morgan Stanley. Just sticking on that same subject. Could you provide color and context behind the investment initiatives in non-China emerging markets and acceleration of growth anticipated in these regions. You highlighted Latin America and MENA, Russia in the press release. And the reason why I asked the question is, in 2018, you increased marketing investment from mid-single digits to 10%. And then we saw what happened in terms of the acceleration in China. So if you could help us understand how much incremental investment you’re putting into these markets and how much inflection you’re assuming. When I step back, 60% of your EM sales are in China, 40% non-China. For most companies, it’s 30-70, the other way around. So maybe comment in terms of your expectations of the balance going forward, your comments around diversification of EM. And then we’ve talked about VBP and we’ve talked about NRDL. Are other countries in these regions considering similar schemes, which could accelerate the uptake of your new medicines and potentially accelerate the decline of legacy medicines?

Pascal Soriot

Operator

Have many questions into one. The investment, I mean, we will continue to invest in emerging markets. If you remember many years ago, a number of years ago, we guided for the emerging markets to grow at high single digit. In fact, we’ve delivered low double-digit growth rate, of course, driven by China, but not only China. And in fact, interestingly, in the last year or maybe a little bit more than a year, we’ve seen an accelerated growth rate in non-China emerging markets. So we have to continue supporting this. The Russian team did an outstanding job last year and they grew tremendously, but not only Russia, many other countries. So I don’t know, in terms of investment, we’ll continue supporting this growth, and it’s all included in the guidance we gave you for 2020. So I can’t be more specific than this. And that’s it, right? The other question, the other part of the question?

Ruud Dobber

Analyst

How the schemes like value-based pricing...

Pascal Soriot

Operator

Yes. No, outside of China we haven’t seen anything specific. It’s just like governments are basically continuing to try and save money out of all products, and we work hard to get access for innovation. There are countries where actually, it’s working faster than others. And again, Russia is a good example of a place where we have got access for innovation. We’re making good progress in – it’s not an emerging market, but it has tended to be a difficult market, Poland. Poland is a large country, as you know, but it has been a country where access was difficult. We made very good progress in terms of getting access for innovative medicines. We’re getting access in countries like Korea. Brazil is also doing quite well. So – but nothing really as specific or dramatic as what we have seen in China. We’ll have to take one last question, sorry about this. Yes, go ahead.

Manny Papadakis

Analyst

Manny Papadakis from Barclays. Two follow-ups; one for, José, quickly on – and as we said, there’s been no further incidences of Grade V IDL, in 5.4. I think in December 8, you was kind enough to say there’s been no further case of Grade IV or V and only one for the case of Grade III. So could you just confirm that is still the case? And then in terms of future clinical development plan stage, you also outlined potentially aggressive set of programs, including adjuvant, which you’ve yet to confirm their meeting in December. So any further thoughts you can provide us there? A quick follow-on on Tagrisso first-line NRDL. Are you expecting to take a price hit when and if that approval comes at the end of this year? And then Lynparza. Could you just talk about the potential speed of uptake assuming a prostate approval in the second half of this year in terms of the biomarker hurdle to utilization and D&E across therapies as well? That’s it.

Pascal Soriot

Operator

So I mean let me go over Tagrisso, China and IDL because there’s not much we can add beyond what we’ve said in the past. It’s really – getting access to first line, we’ve said a number of times, will be more challenging because, of course, the volume is so large, the budget impact is going to be substantial. So we expect that there will be difficult discussions around pricing. But beyond that, I can’t say much more. The – I think the more critical question is relating to Enhertu actually, I will say. And maybe Dave can say a couple of words on Lynparza uptake.

Dave Fredrickson

Analyst

The question on Enhertu was about early clinical trials or?

Pascal Soriot

Operator

It was basically Daiichi announcing a number of new trials. And also, can you confirm there hasn’t been any new cases of ILD as such? José Baselga: Yes. I already commented on ILD in my – in one of the answers to somebody from Deutsche Bank.

Ruud Dobber

Analyst

I think the – of Stage V as well.

Pascal Soriot

Operator

Yes, you said Stage V and Stage IV. José Baselga: Stage V. Well – still in Stage – yes, yes, I confirm that. I think Stage IV and – yes, I confirm that. The – we – as Daiichi has said, and we totally are partners, we’re going to be launching a number of clinical trials that is quite ambitious. So – and it’s very clear in the direction of going early into disease, right? So we are launching in the near future the trials in the early disease setting, neoadjuvant and adjuvant, and also first line. Now I cannot comment on other lines because our policy is not to comment on time lines, I’m sorry, until the clinical trials are announced. So they are coming, and we’ll give you more details as they become official.

Pascal Soriot

Operator

Very good. So very – so sorry, we will have to finish here because we are already overtime. Thank you so much for your interest. And look forward to another great year in 2020. Thank you. Bye.