Ladies and gentlemen, thank you for standing by. Welcome to the Sanofi 4th Quarter 2020 Earnings Call and Virtual Capital Markets Day. We have planned for a 15 minute break between both events. You may remain connected to the Zoom link for all sessions. I would now like to turn the call over to Eva Sheffer Janssen, Head of Sanofi Investor Relations.
Please go ahead, Eva.
Good morning, good afternoon, and good evening to everyone. Thank you for joining us to review Sanofi's 20 2Q4 results, followed by a dedicated Q and A session. In about an hour, we will begin our virtual Capital Markets Day presentation and As usual, you can find the slides to both sessions on the Investors page of our website at sanofi.com. Moving to Slide 2. I would like to remind you that information presented in this call contain forward looking statements that involve known and unknown risks, I refer you to our Form 20 F document on file with the SEC and also our Document d'or registrement Universelle for a description of these risk factors.
With that, please advance Slide 3. Our speakers for the earnings portion of the presentation today are Paul Hudson, Chief Executive Officer the Global Business Unit Heads, Bill Sibault, Thomas Triumph, Olivier Charmey and Julie Van Angewal and Jean Baptiste de Chatillon, Chief Financial Officer. Paul will make some introductory remarks, followed by our GBU heads, who will review the Q4 performance of their respective businesses. Jean Baptiste will provide an overview on the key financials, and we will then open for the dedicated Q4 earnings Q and A session. For the Q and A, you have With that, I'd like to turn the call over to Paul.
Well, thank you, Eva, and welcome to everyone and thank you for joining us Today, apparently a record number of joiners, so obviously creating a lot of interest in the story and how we're doing. So 13 months following the announcement of our play to win strategy and in the year of a global pandemic, we're delivering 3.3% sales growth in constant currency, Ahead of the 2.8% growth the year before. I'm extremely proud of our achievements. Dupixent has become Sanofi's number one product in 2020, Reaching EUR 3,500,000,000 in sales and at a growth rate of 74%. Our influenza vaccine franchise crossed the EUR 2,000,000,000 mark Responding to the public health needs with our differentiated sorry, differentiated flu products.
Specialty Care grew strongly during 2020 And despite fewer new patient starts due to the COVID environment. General medicine sales in 2020 were lower reflecting the implementation of the VBP in China We've made progress on volume and then further impacted by elective procedure delays, especially during Q2. Our bottom line grew faster than our top line as we continue to identify efficiencies and reallocate spending to our key growth drivers. Across the sector, We saw companies lowering their spending throughout the pandemic. The difference is that we are implementing a disciplined active program of overall cost reduction and reallocation that will remain after COVID.
As JB well explained, we have already achieved approximately 85% of our 2022 savings target in just 1 year and feel confident to increase our target overall. This year has proven that we have resilient yet attractive businesses that set us up well for continued growth. I'm really confident Tremendous quarter. Sales grew 4.2 percent, while business EPS grew 9.8%, which bodes very well for 2021 overall. Key growth drivers were Dupixent 54% up compared to the same quarter last year and our differentiated vaccine business, which grew 15% with food sales of 25% in the quarter.
To achieve a nearly double digit EPS growth, we delivered another quarter of P and L leverage supported by further efficiencies and reallocating spending to growth drivers. With that, I'm now turning it over to the GBU Heads. And to provide more details on their respective businesses, let's first start with Dupixent. And Bill, over to you.
Thank you, Paul. Starting with Dupixent, sales reached €3,500,000,000 for the year, a growth of €1,500,000,000 over 2019. Strong sales momentum continued into Q4 with sales of €982,000,000 reflecting outstanding performance both in the U. S. And ex U.
S. Across all three approved indications. This was all done in the backdrop of the 2nd wave of COVID-nineteen. In the U. S, patient visits continued to be approximately 80% of pre COVID levels and outside the U.
S, Local lockdowns prevented many patients from visiting their doctors. Other highlights in the quarter included Dupixent's listing on the China NRDL Just 5 months after launch, 1 year earlier than the initial best case scenario, enlarging the accessible adult population with atopic dermatitis To at least 150,000 as of March, a number almost as large as the roughly 230,000 patients Treated with DUPIXENT worldwide today. The opportunity in China may grow to around 900,000 patients over time for adult AD alone. In Europe, Dupixent is now approved for children 6 to 11 years of age with severe atopic dermatitis. Dupixent is the 1st and only biologic medicine approved in the pediatric patient population.
Based On the continued successful launch execution, we are more than ever before convinced in our greater than €10,000,000,000 peak ambition. On Slide 7, I would like to share with you some insights that further exemplify Dupixent's uniqueness. Dupixent steadily increased sales quarter after quarter in the U. S. During 2020, but that wasn't true for every other dermatology biologic over the past 4 quarters.
What set Dupixent apart in 2020 was the commercial execution and its product profile. As we move into 2021, we are even more confident in Dupixent's market leadership. Recent top line data readouts from potential Future entries in dermatology and respiratory have not changed our confidence in Dupixent's position as the 1st choice systemic therapy based on its clinical profile balancing rapid and sustained efficacy with long term safety. On Slide 8, looking across our Specialty Care franchises, sales grew strongly by 18% in the 4th quarter. Besides Dupixent, oncology sales grew strongly driven by the newly launched products, Sarclisa and Libtayo.
Rare blood disorder growth was higher than prior quarters as sales of Alprolix and Eloctate to our collaboration partner Sobei were higher than usual due to a change in the supply agreement. In multiple sclerosis, Abagio's growth Slowed to 4% globally and was flat in the U. S. Following the entry of competition. With around $2,000,000,000 in annual sales, Abagio probably reached its peak in 2020.
With that, I'll hand it over to Thomas to update you on the vaccines business.
Thank you, Bill. Q4 2020 delivered a strong quarter of growth in the mid teens driven by higher Influenza sales. But before we dive further into the flu franchise performance, I would like to highlight the continuous strong performance across our pediatric combination vaccines portfolio, Growing by 20%. Main driver was Exaxim, our exavalent pediatric vaccine, especially in the rest of the world area, helped by favorable phasing of our polio vaccines. Importantly, our meningitis franchise returned to growth in the quarter, driven by catch up in the U.
S. Following COVID-nineteen release delays earlier in 2020. Finally, as expected, The pandemic continued to weigh on our travel and adult booster vaccines. For the full year, you've seen that we grew 9% in 2020, the 2nd year in a row of high single digit growth at the upper end of our mid to high single digit growth outlook announced at Capital Market Days in December 2019. Next slide.
Here, you can see focusing on flu vaccines. As already mentioned by Paul earlier, Our Flu franchise exceeded the €2,000,000,000 mark for the first time ever, an increase of 38% compared to 2019. There are three main reasons for that. First, we responded to an increased demand and shipped more than 250,000,000 doses worldwide, up over 20%. 2nd, we benefited from an acceleration of vaccination rates as a result of the pandemic, especially in Europe.
And 3rd, we continue to execute on our strategy to shift our portfolio to differentiated vaccines that offer a higher degree of protection for the most vulnerable people. Differentiated vaccines accounted for nearly half of our global flu sales in 2020, up from around 35% only 4 years ago. Our Our successful differentiated products in the U. S, Fluzoneidos and Flublok, are now available in Europe under the brand names of Effuellda and Supentech, respectively. We therefore remain confident on the future growth prospect of our Flu franchise.
Our differentiated products currently set the standard in terms of efficacy, And they are expected to remain a significant growth driver in the coming years with broader availability outside of the United States of Finally, let me use this opportunity to say a few words on the mRNA technology, which seems to work really well on COVID-nineteen and could also be applicable for flu. Having said that, clinical data in seasonal influenza still have to be generated and will have to surpass the efficacy as well as a strong safety benchmark set by our influenza differentiated vaccines. We are now getting ready to start a Phase 1 trial of an mRNA flu vaccine this year as part of our collaboration with Transcendio. Regardless of iDose, recombinant protein, mRNA Our combination of both platforms, we do intend to remain the leading provider of flu vaccines worldwide, protecting people all around the globe. With that, I hand over to Olivier.
Thank you, Thomas. As expected, our General Metals in China business Return to growth in the Q4 growing at 4% with strong volume gains from Plavix and CoaTribel, up 78% for the year. This strong trend confirm our successful VBB bidding strategy, which delivered as planned. While the usual year end true up took place in the U. S.
In Q4, we know that globally, the decline in the diabetes business saw Significant moderation compared to previous years. This positive trend that we are seeing in our diabetes business It's mainly driven by the growth of 2.0 in Europe and the rest of the world as well as Aliqua uptake in all geographies. With the launch of Tujio in China in Q4, we are confident in the outlook of the diabetes business in our key markets. I will elaborate on this in more detail at the CMD session. In Established Products, we saw strong performance from Lovenox globally, benefiting from its continued inclusion in WHO guidelines for hospitalized COVID patients.
Tail products of the EP in emerging markets faced some headwinds from the COVID environment. Going forward, to improve the growth profile of the EP business, We continue with the portfolio streamlining, and we are making solid progress in driving simplicity and agility, such our go to market digital model. I look forward to sharing with you more on our strategic priorities for the General Medicine portfolio a little bit later today. With that, I hand the call over to Julie.
Thank you, Olivier. Similar to Olivier, I look forward to speaking with you again later today to share with you our team's strategic priorities to change the trajectory of our CHC business to grow our top line while continuously improving our bottom line. But let me now very briefly touch base on our 4th quarter performance of the CHC business. Following the annualization of Zantac, the U. S.
Returned to growth with strong performance from the allergy, digestive and sleep categories. And as a result, I'm happy to share we're back to gaining share in the U. S. OTC market since October. I would especially like to highlight the U.
S. Allergy category, which grew by 13% in Q4 with strong performance of our brands Allegra and Xyzyl, both benefiting from strong 360 Marketing programs, anxisal from product placement and a popular chain of U. S. Membership only clubs. Globally, Digestive Health Brands, Essentiali and L'Uncle N'Q'Annex, Performed well as many consumers adapted to different lifestyles during the pandemic, including a more sedentary life Outside the U.
S, the cough and cold category was down 31%, driven by our high penetration in cough in Europe and an overall week off in cold season across regions because of social distancing as well as lower in pharmacy food traffic. With that, I hand it over to our CFO, Jean Baptiste.
Thank you, Julie. So Paul mentioned in October that we are committed to fully Embrace sustainability in our plateauing strategy and it's happening. It's happening across the company. As an example, the finance team linked the renewal of our €8,000,000,000 revolving credit facility with some of our key targets. We had seen many green bonds in the past, but this was This one was a first with an ESG revolving credit facility.
And you will see over time many other proof points across the company. On Slide 14, let's turn to financial performance. Company sales increased 4.2% in the 4th quarter, an acceleration versus We delivered another quarter of P and L leverage driven by further efficiencies. Within the lower R and D spend, you have already a higher spend on the Specialty Care franchise due to the reallocation from diabetes and cardiovascular. This operating expense efficiencies more than offset the decline of 120 basis points in gross margin due to U.
S. Diabetes true ups and product mix of the general medicines business. Consequently, BOI grew almost 10%, and our BOI margin increased by 60 basis points to 21.9 percent in the quarter. So we have been able to deliver this margin improvement at the same time as accelerating investment in Dupixent and vaccines and absorbing the Syntorex and Principia R and D spend. On Slide 15, full year 2020 P and L.
Well, I would like to draw your attention to the last line on the slide. Our BOI margin Increased 120 basis points to 27.1%, well on track toward Our communicated BOI margin ambition of 30% by 2022. So going forward, you can expect Operating expenses to grow again due to investments into our expanding pipeline on future launch activities. At the same time, you can expect to see a gross margin improvement from this low point of 2020. With this in mind, Let me give you an update on our progress to accelerate efficiencies.
On Slide 16, as you know, we communicated in December 2019 our We plan to deliver €2,000,000,000 in cost savings by 2022. Of this total, we expected around €500,000,000 to come from reduced Spending deprioritized businesses around €1,000,000,000 from a range of smart spending initiatives on the first of €500,000,000 from operational excellence, including COGS. In 2020, we have achieved around €1,700,000,000 of savings, almost 85% of for 2022 target. We made progress across all potential sources of savings, especially from deprioritized businesses on operational excellence where we have surpassed the target. Following these accomplishments, we are increasing our cost savings target by €500,000,000 to €2,500,000,000 by 2022.
These savings will be derived from continued operational excellence, And we plan to reinvest 100 percent of this extra €500,000,000 of savings to drive the top line and fund the pipeline. On Slide 17, we delivered another year of strong free cash flow growth, mainly driven by Sanofi's solid business performance Free cash flow increased by more than 70% against full year 2018. So [SPEAKER UNIDENTIFIED COMPANY REPRESENTATIVE:] We delivered a strong underlying performance. And as a matter of principle, we do not update our midterm targets. But I guess you will understand That concerning free cash flow, we will maximize it as much as we can.
On Slide 18, I want to transition to Sanofi's annual dividend payment, which the Company has consistently grown for the last 26 years. As a result of Sanofi's performance in 2020, we announced that the board has proposed a 0.05 Uplift in the dividend to €3.20 A growing dividend remains an important element of our capital allocation policy, behind organic investment on business developments, which are our main priorities. On my final slide, we have set out our full year guidance for 2021 business EPS to grow in the high single digit at constant exchange rate. On ForEx, we see around 5% negative foreign currency impact based on January and average exchange rate. Lastly, I want to highlight pushes and pulls for 2021.
Well, on the upside, we expect strong growth from Dupixent on vaccines and continued efficiency benefits to be reinvested in growth engines and pipeline. In addition, we will have the annualization of the China VBP impact from Plavix on co approval. Also, Sanofi's tax rate for 2021 is now expected to trend towards 21%. This is our estimate, including the positive impact of the French taxation reform, but our current forecast does not include a potential change in U. S.
Tax legislation. On the downside, we expect the COVID environment to continue to impact us in H1 with potential gradual normalization in the second half of the year. In addition, we expect adverse impact of foreign currencies, primarily in the first half of the year on continued U. S. Diabetes price erosion.
So taken together, these factors suggest that our growth will be weighted to The second half. In addition, you should note, but I'm sure you have it in mind, that the Q1 will face a high basis for comparisons as Q1 2020 Does not fully reflect current market dynamics due to the pandemic. Well, so after 6.8% growth at TR in 2019 On 9.2% in 2020, well, we are on track for another year of high single digit growth. Well, you can look back on past performance, But definitely, this is not the same Sanofi. Let's open the call now to Q and A.
Eva?
We will now open the call to your As a reminder, we would ask you to limit your questions to 2 each. As a reminder, you have 2 options. Option 1, click the raise hand icon at the bottom of And now, analyst.
And now we will take the first question from Pete Verdult at Citi. Pete, please go ahead.
Yes. Thank you very much. Pete Verdult, Citi. Two questions, maybe kicking off with Thomas first on vaccines. Just Could you comment on where vaccination rates ended up this past winter in Europe and the U.
S? And although you've given us a split by value, could you just Remind us perhaps from a volume perspective the mix between your differentiated and commodity flu business. And then secondly for John on upcoming Is the data in house yet? Can you remind us whether we will see PFS as well as ORR data? And should we be using the PALOMA 3 and MONARCH 2 data as the benchmarks when we assess the SERP data?
Thank you.
Okay, Peter. Thank you. Thomas, over to you.
Thank you, Peter. First, in regards to the vaccination coverage rates, We don't yet have final numbers because this is still ongoing by every single country in terms of North America or Europe. But it's clear to say that due to the COVID-nineteen pandemic, we've seen some increase in the VCRs. I would expect Roughly an increase of the U. S.
Market by around 14%, 1.4%. But again, that's not final numbers. It's with Some interim IQVIA data. And in Europe, we've seen a significant increase on the vaccination coverage rate. Also a few points, but we'll know more by In the next couple of months once we have the final numbers.
Now when it comes to value and volume split, overall on the overall Flu business, If I look at 2020, you've seen that roughly it's a balance between volume and value in terms of the 38% increase in the Flu business. And of course, as mentioned, we're going to increase further the differentiated portfolio. We are very happy as we've seen the introduction of FUELDA in Europe. We believe it will be a strong driver of growth in Europe in 2021 and the years after. So I will say that we'll see more and more Increase of the differentiated flu in both in volume and in value in next year.
Thank you. Thank you, Tom. John Reed, maybe you could Update on what data we have in house and the outlook for sharing data on SIRD and Sinestro.
Absolutely. Thanks, Paul. So we'll be sharing data on the Phase Ib study, which set the stage For the pivotal study in combination with Palvo that will be shared at a medical conference middle of this year. In terms of the first pivotal readout that will occur the first half of this year in the second and third line setting as a mono That primary endpoint is progression free survival. Of course, we'll have overall response rates and clinical benefit rates as All those secondary endpoints, but that will be the PFS will be the primary endpoint.
Thanks, John.
The next question is from Vimal Kapadia at Bernstein. Vimal, please go ahead.
Great. Thank you very much for taking my questions. Vimal Kapadia for Bernstein. So can I just ask On Venglustat, please? Clearly, disappointing to see the update on GVAPD, but given safety continued to be favorable And the biomarker showed consistent and predictable GL1 reductions in both the plasma and cerebrospinal fluid.
Have your views of success actually changed for the product in ADPKD for the pivotal data in 2022. And then just tied to that, should we still be expecting kidney volume data this year, Which may be fileable with FDA depending on the outcomes. And then my second question is again back to influenza. You know, Clearly, a strong 4Q and a stronger than the 3rd Q, which was above your previous comments. So I guess, can I just ask what drove that stronger than 3Q performance?
And then secondly, how should we think about the flu progress in 'twenty one? Do you expect patients who took a vaccine this year that typically do not to Fall off in 2021, should the pandemic be in a better position? Or do you expect incremental demand in 2021? Thank you.
Thanks, Vimal. I'll come to Venglustat in a moment. I'll make a comment before John, but let's just do flu while we have a chance. Q4 over Q3 and also outlook for 2021.
So Q4 versus Q3, It's related to the 3 drivers we've mentioned before. And clearly, COVID-nineteen has shown an increase of influenza rate in 2020. And therefore, there was an expansion, I would say, of the season and hence the balance between Q4 and Q3. Moving forward, we expect to see Q3 and Q4 So roughly 50%, 50% balance. Of course, there are many different factors influencing that.
For example, What will be the new strength? When they are announced? What's the impact? So as we get more data points, we'll be able to give you some more guidance on that in the coming Now when it comes to 'twenty one outlook, what we've observed in the past is a slight decrease in this year post pandemic situation. So there might be a couple of points down next year in terms of overall influenza this year.
But what's very, very important and very specific To the Sanofi Pasteur portfolio of influenza vaccines is that it's the growth of our differentiated vaccines, which come with premium in terms of efficacy, but also Premium in terms of pricing. And I think that from a value perspective, we'll be able to be well positioned to deliver on our mid to high single It's growth ambition that we have for the GPU and Influenza will be a part
of that. Thanks, Tom. John, we'll come to you in Bengtista, but maybe we are going to go through it a little bit more detail later at Capital Markets Day. And I think, Wim Your summary, if you like, was spot on, at least how I felt when I saw the data. That was it's one of those Sort of paradoxical moments where, although we were disappointed in Parkinson's for those that are struggling, we increased our confidence outside of that.
So maybe I'll let John
Yes. Thanks for the question. Just to get to the question that you asked about the total kidney volume and when we'll have Data that will be next year. So that's when we'll have that readout. But in terms of the mechanistic hypothesis that we're It is different from the Parkinson's situation in the context of the autosomal dominant polycystic kidney disease.
The glycosylglipids that are being impacted through the modulation of that pathway are acting like Signal transaction molecules that affect differentiation of the kidney cells. And so it really is a different mechanistic hypothesis, really an independent hypothesis compared to what we tested in Parkinson's.
Okay.
John, I think we'll We'll cover a little bit more later the read across, but I think you got to the nub
of it.
Next question?
The next question is from Joe Walton at Credit Suisse. Joe? Joe, please make sure you unmute your phone. Okay. So let's move to Graeme Parry at Bank of America Merrill Lynch.
Graeme.
Great, thanks. Can you hear me? Yes. Okay, perfect. So Just going back to vaccines again I'm afraid.
So could you just help us understand what growth in vaccines is assumed in guidance and in particular for flu? I think Thomas did you say that growth It would be a couple of points down on 2020, but you're still expecting to see flu grow off that 2,500,000,000 base. And what sort Recovery and cadence of covering expecting in travel, meningitis and boosters, presuming that's all sort of second half loaded. Secondly, on Dupixent, obviously accelerating growth in Q4 on prescriptions. Can you just help us understand what's happening on pricing as Go into this year, has there been any pressure from payers at all?
Are you still enjoying pretty good coverage without too much pressure there? And then third question is just on other operating income. That was around $100,000,000 lower or the expense I should say was lower about $100,000,000 lower than consensus. You actually had quite a high Regeneron pay away So just are there some low level one off gains sitting in there? And if you could just help us understand the size of those.
Thank you.
Okay. Well, we'll start with Tama. I would just add that I think we would all believe as much as we look to be back traveling again, The more exotic travel perhaps will be much later in the year and perhaps beginning of the following year. But Tom, I'll leave it to you.
Thank you. Graham, Basically, now what I was saying is that and it's important to be precise, the overall Vaccines GBU growth is Expected into the mid- to high single digit trajectory as we've committed from a 'twenty eight percent to 2025. When I was mentioning minus 2% to 3%, It's on the vaccination coverage rate for the full market, so not about Sanofi Pasteur. When it comes to us, we Expect influenza to remain a key growth driver of our overall trajectory next year and the years after. And again, it's about a few factors.
You understood the importance of efluelda, I. E, fluzolidose growth in Europe and still in North America. That's very important. We expect also flu blood growth to keep going. What's also important for you to know is that we discussed it in the past, but you know that we will keep investing in our capacity.
Notably, in 2021, we'll have the start of our new U. S. Facility for Fluzone antigen that will start to produce from the year 2021. We've committed in the past, but of course, that's an important driver when it comes to Fluzone Idols. And same thing, we had also invested into our vaccine group influenza trial vaccine, sorry, in France in order to make sure that we can meet the demand.
So that's very important moving forward for flu. In parallel, to sustain the mid-twiceingledigit growth of the GBU, the recovery in meningitis, you've seen in the Q4 That meningitis was turning positive and therefore, we expect this to come back in 2021. That's an important part of the driver. As mentioned by Paul, I expect travel and then make to still be impacted in 2021 for the obvious reasons we know. That's more a 'twenty two play in our view.
That you've also seen and I highlighted at the beginning of the call that our pediatric combinations have done well this year like the previous year. And we think that in emerging markets, they will keep their growth trajectory in 2021.
Thanks, Tom. Bill, maybe you want to jump in on Dupi access quarter 1 and onwards, what you see as the dynamics?
Yes. So thanks, Graham. So first of all, We're in a really highly favorable access position. We have greater than 95% of commercial lives having established criteria for For AD and asthma. And as we launched the product, we knew a couple of things.
We knew that we'd be in multiple indications And we knew that there would be competition in the future. So we've strategically approached this and we've done very well. Looking ahead to Q1, you would expect like in every other Q1, you have kind of a resetting of Patients of insurance, so your patient assistance programs and so forth have that impact. But we believe we're in a really strong position. Clearly, when you have competition coming in, the more companies there are, you expect some, impact on gross to net.
But As I said, we started out with a plan knowing exactly how the market was going to unfold, and we think we're in a really favorable position for Q1 and 2021 in general.
Thank you. And then, JB, ROI?
Yes, Graham. You We have an accumulation of small deals. We are very active on the front of divesting some of our molecules in EP portfolio, a bit in Consumer Health also, that's to execute on our commitment of the Capital Market Day and we are actively executing on it almost computing to 100,000,000, Below 100,000,000, but quite near on Q4. Cash wise, it's much more important what we are doing. But as you know, we are pushing down some goodwill accounting wise when we account for those sales.
So it's not very Really impacting on BY, but Q4 was higher.
So I have on the chat two Questions from Florent Cespedes from Societe Generale. The first one is on 2021 R and D news flow, specifically with regards to BIVV001 and And what the new time lines are? The second one is could you be more specific and where you intend to redeploy the $500,000,000 additional savings?
Okay. Well then, John, maybe one update on BIVV001 and Fertusseran for this year. And other a little bit more broad question about news flow for this for 2021, yes. John?
Yes. Thanks, Paul. So BIVV001, which is now known as We have dosed the last patient is now the study is fully enrolled. Last Patient has been enrolled. It's a 52 week study, so that will be reading out early in the following year.
So we're slightly delayed due to COVID, but are still expecting to have a submission in roughly the same timeframe that we've disclosed previously. With the atusiran after the voluntary hold to reconsider dose and schedule, this study has now been restarted. 97% of patients remained on study. The investigators and patients were very eager to resume and we're delighted that we were able to Get back on track with that study. We'll be having dialogue throughout the 1st part of this year with the health authorities In terms of what additional evidence they'll want to see in order to submit the NDA, So we don't yet have an update for you on the timing for the vitusiran final submission.
John, broader news flow for 2021?
Well, for 2021, we We'll have 8 pivotal readouts that will include amsinestrant in the first Half of the year for the monotherapy in the second third line breast cancer as well as 2 Libtayo readouts. And then in The second half of this year will have 2 Dupixent readouts for spontaneous urticaria, chronic spontaneous urticaria as well as for Pemphigus nodularis, so 2 more dermatology indications. We'll also have rilzabrutinib pivotal data for Pemphigus vulgaris, another dermatology indication. And then we'll have a And then we'll have a readout for Sarclisa in the frontline of myeloma context for the transplant in So expect a rich new year of news flow throughout 2021.
Thanks, John. Maybe just add and we may be able to talk about a little bit later, but the investigative feedback on Fertusseran, I know everybody was disappointed that we'd be on a voluntary hold, but Actually, it's provided us with some much richer insights into the potentials for interval and dosing, which while nobody wants to take a short delay, Actually, we think the profile may improve. So we will see. We'll see what the data says. But it was we wouldn't have found this out, I think, unless we've been on this journey.
So okay, Next question?
Yes, another question from the Jeff from Jeff Porges. What proportion of your volume now is in the U. S. And globally is in premium brands? This is for influenza vaccines.
So it's a volume question on split U. S. Ex U. S. And the second part is, are you underway with combined flu COVID vaccine and do you believe COVID will become another repeated new vaccine annually?
And Tom, just before you answer those great I did neglect to throw the question to JB on the reallocation into R and D.
Yes, thank you. I think it's an important question to read through what happened already in 2020, because it was a very significant swing, it was €500,000,000 savings in 2020 from effectively arbitrage within our So it was happening very quickly and you see it on my slides about savings. That's why in 2020 already, We saw an acceleration of the spend of R and D in Specialty Care, and that's where we are, of course, investing. Efficiencies Also have helped accelerating this level of spend in R and D in Specialty Care. So you were asking of the €500,000,000, the next 100,000,000, yes, they will come, a lot of them will come this time from COGS, which will of course tie up with the improvement we are expecting on the gross margin.
And yes, we are looking at reinvesting them because we are gaining confidence on our top line growth. So we it makes us much more confident that we can reinvest it Behind our pipeline, which is, of course, more and more promising, we need to invest into it. So you remember that with Syntorex, Principia, Keyadis, Qimab, all those companies we have acquired, we will have the underlining Of their cost in 2021, so you can expect to see effectively R and D spend going up, but in a completely different context than before. Instead of being spreaded all over the place, it's really connected to our priorities in Specialty Care and in vaccines. Yes.
I think I hope it gives more color to what we are executing.
Thank you, Pepe. Thomas.
So back First to Influenza and then I'll talk about COVID-nineteen. So for Influenza, again, I think what's important to have in mind is that with the new Fluzone antigen building coming online in 2021, you should expect a growth of both our differentiated vaccines, I. Fluzone Idols, Effelda and Flublox, Supemtech. I do expect growth on both sides of the pond in North America and in Europe, Especially for, again, if you will, you will see that in North America, you will see that in Germany. I expect maybe a significant growth in volume and in value from the different GD2.
Now what would be the impact on the standard dose flu It remains to be seen. That's more linked to the vaccination coverage rate as we've discussed before. Now when it comes to COVID-nineteen and influenza, Great question. A little bit too early to have a definitive answer. There are still many things in terms of Ability to do COVID-nineteen and flu together, you know very well that flu has a very specific logistic, that it's an annual vaccination.
We still need to see what's the what's going to be the need for boosting by when longer the COVID-nineteen shuts duration. So many questions to answer there. But you have noticed that we are very interested. You have noticed that we are starting Phase 1 of mRNA flu vaccine this year, Knowing that we have the influence of X in Lidua worldwide and knowing that we have 2 shots on goal with COVID-nineteen, should there be an opportunity, We'll be just around the corner.
Thank you, Thomas. Next question, please.
The next question is from Joe Walton. Joe, please go ahead. Okay, so let's move on to Richard Vosser at JP. Richard?
Hi, thanks for taking my questions. First question just on China and the recovery there. Just Your thoughts on the sustainability of recovery in China for your products and future price And then aligned to that, just JB, you highlighted increasing confidence in the growing top line. And I note that you're sort of saying general medicines should be flat out to 25. So do you feel confident enough To give a target like you give for vaccines and consumer in terms of growth now, it looks It's like it's all growth going forward, but just your thoughts there.
Thanks.
Okay. Thanks, Richard. Joe, we've tried a couple So maybe you want to submit a question online if you can or we'll try again a little bit later, sorry, in case it's Our responsibility. Let's go to China. Olivier, Xiaomei, maybe you have some views
on the outlook. Yes. Thank you. The market has suffered, of course, in 2020, mainly due to COVID. The definite number is not yet known for the Decrease of the market will come in the range of 10% to 11%.
The market is going to bounce back, and we are expecting for 2021 A growth that is going to be significant, 6%, 7%, 8%, not to say more. Of course, as there has been Price pressure with the implementation of VBP in the last 2 years, we see that, of course, The volume growth continue to be very strong in our hand, and we are very happy with our performance, both on Plavix and Aprovel for The implementation of the VBP, so the China market remains a volume market on General Metin and on Specialty, of course. We continue to see with the registration of Dupixent and the start that for us in The future, a significant portion of our growth will come from Specialty.
Thanks, Olivier. JP, why are you not providing Guidance on the future of the business.
Well, Richard, I'm glad you captured my optimism. That's fine. And that's effectively where I am. We have, I think, a guidance which is quite clear for 2022 with this BOI ratio. And yes, we are really committed To deliver on it, we have a nice now set of guidance out there to help you modeling it.
But yes, We will deliver on 2022.
And maybe just add to that. It's our responsibility as an executive team and the wider organization to Toggle that way. And remember back in Capital Markets Day 2019, we said that we wanted to be able to stick to the BOI and deliver And show you we could you've just seen from the numbers full year 2020 that with 120 basis points improvement that we're You can see the line to where we're going, and you should expect us to deliver those things, and then we'll anchor from there. Next question, please.
We will take final questions from Jean Jacques Lefur at Bryan Garnier. Jean Jacques, please go ahead.
Thank you. We'll come back on the flu vaccine. And for clarity, could we assume that you will be able to add again about €500,000,000 in sales this year as you did last year? And if yes, how can we see the capacity manufacturing capacity If you are successful with the COVID your COVID vaccines, which I assume will take some of them for manufacturing Or is the new U. S.
Factory enough to deliver the additional flu doses? Thank you.
Thomas?
Thank you. Yes, Jean Jacques. So we have made sure that we always Make sure that we secure the demand of our current vaccines. You know that we're manufacturing and supplying a lot of different vaccines that are critical in need even in COVID-nineteen pandemic times. And we made sure that our supply capabilities are growing and it's not linked to the COVID-nineteen vaccines development that we are doing.
So We have everything we need to increase. As I mentioned before, the Fluzone antigen building is already up and running and [SPEAKER JEAN FRANCOIS VAN BOXMEER:] To produce as we speak now for 2021 Northern Hemisphere, that's very important for us moving forward.
Yes. Okay, good. Thank
you, Nick. Sorry, looking at sales, we assume that you may you will be able to add again €500,000,000 about?
No. So no, again, the story of influenza is going to be a growth trajectory, Which is a question in between growth from differentiated vaccines versus nondifferentiated vaccines in a market that most likely in non pandemic period Compared to pandemic period, will be probably lower. So I expect us to perform well in a declining market for flu just for next year. But we are not in the magnitude of €500,000,000 of course, because we are not in a pandemic situation at all. So you need to look at the continuous growth compared to the average trend of Over 5 years, for example.
Okay. So time is over for this first part. So let's meet in 12 minutes for the Capital Market Day. Thank you, everyone.