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Sanofi SA
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Ladies and gentlemen, thank you for standing by. Welcome to the Sanofi Investor Call on the Q3 2020 earnings. I would now like to turn the call over to Eva Schaefer-Jansen from Sanofi Investor Relations. Please go ahead, madam.
Thank you, and good morning and good afternoon to everyone on the call. Thank you for joining us to review Sanofi's third quarter results. As usual, you can find the slides for this call 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, uncertainties and other factors that may cause actual results to differ materially. I refer you to our Form 20-F document on file with the SEC and also our Document d'Enregistrement Universel for a description of these 3 risk factors. With that, please advance to Slide 3. Our speakers on the call today are: Paul Hudson, Chief Executive Officer; our GBU heads: Bill Sibold, Thomas Triomphe, Olivier Charmeil and Julie Van Ongevalle; Jean-Baptiste de Chatillon, our Chief Financial Officer; and also John Reed, Head of R&D. Paul will make some introductory remarks, followed by our GBU heads, who will review the third quarter performance of their respective businesses. Jean-Baptiste will provide an overview on the key financials, and John Reed will update you on recent pipeline developments. After concluding remarks, we will open for a Q&A session. With that, I'd like to turn the call over to Paul.
Well, thank you, Eva, and hello to everyone on the call. So it's a year since my first earnings call. And quite frankly, I continue to be astounded in the way of our people have embraced our Play to Win strategy, especially in the backdrop of a global pandemic. The third quarter is another strong proof point for the organization that we are delivering on this strategy relentlessly. Sales and EPS grew by 5.7% and 8.8%, respectively, in constant currency. Driving this performance was another outstanding 69% increase in Dupixent sales and double-digit growth from our Vaccines business, which actually set a record for flu vaccine sales in the quarter. So really, a tremendous quarter, and we are increasing our full year guidance to 7% to 8% EPS growth at CER, and Jean-Baptiste will provide the details shortly about that. As I highlighted last quarter, our leadership team is now complete, and I'm excited to have each of our GBU heads talk about their businesses today. Given the very dynamic business environment in the U.S. currently, I wanted to highlight how well positioned Sanofi is in the key market for continued success with our innovative medicines and differentiated Vaccines business. In the third quarter, the U.S. business represented 42% of company sales, with a strong double-digit growth. Looking to 2021, we expect our payer coverage to be largely unchanged. Sanofi has a low single-digit exposure to Medicare Part B and Medicaid as a percentage of company net sales. And in fact, Dupixent has around 70% of its U.S. business in the commercial channel. We're also a market leader in flu vaccines in the U.S. And as Thomas will show you later, the bulk of our sales and growth in this category is coming from differentiated vaccines where pricing is resilient and reflects the value we bring to society. And I know there has been intense focus on the insulin market in recent years. As you know, Sanofi has acted to consistently improve patient access and affordability. To summarize, based on what we know now, I remain very confident about Sanofi's growth prospects in the U.S. in the coming years. You've heard me talk about the return to growth in China in the fourth quarter, driven by our successful VBP bidding strategy and adjusted go-to-market model. Clearly, in this important market, we pivot towards our innovative medicines in Specialty Care and Vaccines, in line with China's health care priorities. The approval and launch of Dupixent in record time, and we said that, I think, in the last quarter, has been followed by an incredible uptake with over 1,100 atopic dermatitis patients on therapy after only 8 weeks. Now while there is some pent-up demand initially, the uptake remains incredibly strong. Remember, Dupixent is only available in the private pay market at this time, so a very impressive early demand. We're fast expanding our Vaccines business in China, playing an important role in increasing immunization rates in this large population. We have emerged strongly from the crisis that enveloped the sector in the past couple of years, and Pentaxim has hit more than EUR 100 million of sales in the third quarter alone. As we expect to return to growth in China, we are pivoting towards a rejuvenation of our portfolio and expect recently launched products such as Dupixent, Toujeo and PRALUENT to contribute to sales in 2021. Over the next 5 years, China is expected to be a key growth contributor to Sanofi. On Slide 7, let me just say that Play to Win isn't simply a slogan here. We are currently accelerating and delivering on transformational science and business execution, including our key growth driver in the second largest pharma market, making a meaningful acquisition, Principia, and adding yet another breakthrough designation for Dupixent. I'm excited that John will share with you some detail and important updates on our progress in R&D later on the call. It is also worth me saying just before I go to this slide, that I feel the company is perhaps even uniquely positioned to take on what is ahead of us. We have a wide portfolio. We have a growing asset. We have Dupixent at the head of that. Our pipeline is moving. And we're doing all this and that progress that I said that we made in Q3 is incredible given the nature of the lockdown and everything that we face as a company, as an industry and as a society. So the progress that we have made during these difficult times, I think, is unique and I think it's sustainable. And I think that's going to be very important as you look forward at how we operate in this great company. So Slide 8. And before I turn it over to Bill, let me reiterate the critical importance of our social sustainability and how we're integrating that into our Play to Win promise. How we make it sustainable over time, I want to draw your attention to a few points. Let me also add that as we get into the CSR work, it's probably been the most interesting thing for me to work on with the team over the time that I've been in the company. Not just did we want to do something incredible for the planet, and I'll talk about that in a moment, we also wanted to do things that only we could do, and importantly, eradicate diseases and take different approaches. And I think this is more than a poster by an elevator. This is a real thing that aligns perfectly with our business. So as I said, in our CSR strategy, we've looked at what we call table stakes on the environment and the sustainability pillar, accelerating what we need and want to do to protect the planet. But then we looked at other areas of societal commitment where Sanofi can uniquely push the brand vision and make a difference. And as I just mentioned, this is the difference. Our global footprint and our long-standing presence in low and middle-income countries and our commitment to broadest access possible to our medicines has pushed us to commit to deliver life essential medicines to the poorest countries in the world and secure an important number of free medicines to the most vulnerable communities in the world. Not forgetting our commitment to eradicate polio and sleeping disease, we're already making great progress. We have also decided to use our new R&D focus on oncology to make a bold commitment to developing medicines for the most difficult-to-treat cancers in children. And in a world like the one we are living, we are 100% committed to develop a senior leadership that is fully representative of the communities we operate in. Talents exist in many forms and backgrounds, independently of gender, race, sexual orientation and any other form of diversity that makes us richer as human beings and more broader minded. The Board and the Executive Committee have just approved our renewed contract with society, and together, we are ready to embrace these initiatives as part of our business priorities. We will continue, of course, to report regularly on our progress on this program. With that, I hand over to Bill to update you on the incredible progress we're making in Specialty Care. Bill?
Thank you, Paul. Let me start with Dupixent, where we achieved the landmark of blockbuster dollar sales in the quarter. This is an important milestone for Dupixent. At a high level, sales growth of nearly 70% was driven by strong performance across all 3 main indications of atopic dermatitis, asthma and nasal polyps, furthered by the very strong launch in pediatric patients with atopic dermatitis. As you can see from the chart, ex U.S. markets, including Europe, contributed nicely to growth and now account for 21% of Dupixent sales. When thinking about our performance outside the U.S., keep in mind that we took a 20% price cut in Japan in April and that we are still rolling out the full range of indications and age groups. By the time we close 2020, we expect to have launched Dupixent in around 50 countries. As Paul already mentioned, this list includes China, where we have been encouraged with the early uptake in the private market. Focusing on the U.S., Dupixent ended the quarter with weekly new-to-brand prescriptions nearing pre-COVID levels. As in-office visits began to resume, telemedicine appointments declined. In-office patient visits with dermatologists and allergists are still around 20% below the levels we saw before the pandemic. Market research suggests that most of dermatologists believe it will be impossible to reach normal pre-COVID patient volume due to safety restrictions and precautions that have been put in place at the state and local levels. So overall, we delivered again a strong franchise performance in a still difficult environment and remain fully confident in our greater than EUR 10 billion peak ambition. Other highlights in the quarter included several important regulatory and development milestones, which will help drive the future growth of Dupixent. These included the positive CHMP opinion in AD for children 6 to 11 years old, the successful readout of our pivotal pediatric asthma study for the same age group and the FDA breakthrough therapy designation in eosinophilic esophagitis. On Slide 10, specifically looking at the U.S. new-to-brand prescriptions, here, you can see both Dupixent's rebound and Dupixent's sustained leadership position in Q3 among dermatologists. Prescription trends suggest that Dupixent has the best-in-class profile in the COVID environment with dermatologists. The type 2 pathway is not involved in viral defense and Dupixent is not an immunosuppressant. On the previous slide, I just discussed our expansion into pediatric AD patients, and this success was driven by Dupixent's unparalleled safety profile. Lastly, Dupixent does not require any lab monitoring and can be administered at home. Slide 11 provides further evidence of Dupixent's differentiated profile. In VOYAGE, the pediatric pivotal study, Dupixent showed meaningful reduction in exacerbations and an improvement in lung function. This is important since these children, approximately 75,000 in the U.S. alone, often struggle to breathe due to impaired lung function. This is consistent with our adult and adolescent data and reflects Dupixent's anti-IL-4 IL-13 mechanism of action that targets underlying type 2 inflammation. Type 2 inflammation in asthma encompasses both the allergic and eosinophilic phenotypes, and represents approximately 80% of moderate to severe asthma and might even be more prevalent in children. And many asthma patients start their patient journey as children. On Slide 12, looking across our entire Specialty Care portfolio, sales grew strongly by 24% in the third quarter. While Dupixent remains the largest contributor to growth, we saw higher sales across all of our specialty franchises despite new patient starts continuing to be impacted by COVID. In oncology, sales from the newly launched products contributed to the strong performance in Q3. In multiple sclerosis, Aubagio grew 7%, reflecting favorable pricing in the U.S. and Germany, partially offset by lower new patient starts which we expect to continue due to market -- new market entrants. With that, I hand over to Thomas.
Thank you, Bill. I'm delighted to report that Sanofi Pasteur achieved new record flu sales in the third quarter of this year, with growth of more than 50%, exceeding EUR 1 billion in total as Paul highlighted before. Within this flu performance, I would like to highlight some important dynamics. First of all, our flu sales in Q3 represent about half of our expected H2 global sales. This number, the split between Q3 and Q4, used to be around 60%, then close to 40% last year. But we are seeing now and you know where it will be about 50% moving forward, especially now that flu vaccination coverage rate increased and that health authorities around the world better understand that vaccinating too early can actually be counter-productive, especially for seniors. So in our view, vaccination are likely to be spread out more evenly on Q3 and Q4 moving forward. The second flu dynamic I'd like to highlight is about the fact that we are seeing a favorable mix shift in our portfolio. As shown, differentiated vaccines account for the majority of our global flu sales in the quarter. In total, we expect to deliver 30 million doses of differentiated flu vaccines to the U.S., of which more than 60% has actually been booked in Q3. Ex U.S., you can expect to see a similar evolution to begin in Europe. In Q3, we actually had our first shipment of Efluelda, our quadrivalent high-dose flu vaccine, and we received a positive CHMP opinion for Supemtek, the European name for U.S. Flublok. Overall, we are confident to maintain our global flu market leadership with a shipment of approximately 0.25 billion flu vaccine doses worldwide in 2020. Simultaneously, the expansion of our manufacturing capacity is on track to meet the projected increase in worldwide immunization rate against flu. In addition, the pediatric portfolio, so-called PPH portfolio, was another strong performer in this quarter. This increase was driven by pediatric catch-up in the U.S. and Europe and by the continued strength of Pentaxim in China. As anticipated, the pandemic continued to weigh on our travel, meningitis and adult booster vaccines. Overall, the Q3 business dynamic in vaccine are expected to remain similar in the remainder of the year, as Jean-Baptiste will highlight to you in just a minute. With that, I hand over to Olivier.
Thank you, Thomas. Third quarter general medicine sales benefited from a continued gradual recovery in demand with sales down 6%, roughly at the rate we experienced in Q2. In established products, we saw strong performance from Lovenox in the rest of the world region. This resulted from inclusion of low molecular weight heparins in WHO guidelines for anticoagulation of hospitalized COVID patients. On the other hand, Plavix and Aprovel declined in line with expectation in China, where we successfully drove strong volume growth for these 2 products largely offset by price erosion on VBP program. You may remember that this time last year, we had anticipated the dynamics of the VBP bidding process, and are encouraged that we were able to deliver our promise of more than 60% volume growth. Global diabetes declined by 4%, both for the quarter and year-to-date. The U.S. glargine business decline moderated to below 9% in Q3. Note that we expect U.S. diabetes performance to be impacted in the fourth quarter, primarily due to business mix weighted towards government channels, including typical [indiscernible].Looking to 2021, we are pleased with our broad formulary coverage for U.S. diabetes portfolio, which remained largely unchanged compared to 2020. In terms of our Play to Win initiative, we continue to streamline the general medicine portfolio in order to drive simplicity and agility as well as optimize cash flows. We have been ambitiously working on identifying growth opportunities for a large part of the general medicine portfolio, and we expect to share the strategic plan with you at an upcoming investor event where digitalization will be part of it. In summary, I'm extremely confident that we are making rapid strategies for us. With that, I hand back to Paul.
So thank you, Bill, Thomas and Olivier for the updates on our businesses. And now I want to introduce the newest member of the GBU leadership team, Julie Van Ongevalle. And Julie joined Sanofi at the beginning of September, and it's a little early to get up here talking, but I'm really excited about the impact she's having already. She brings a deep knowledge of consumers, of course, and digital marketing to accelerate the growth opportunities for Sanofi's Consumer Healthcare GBU. So Julie, welcome, and over to you.
Thank you, Paul. It's a pleasure to speak to you in my first earnings call as Head of Sanofi Consumer Healthcare. Actually, I'm super excited about the opportunities that lie ahead of us. But before I expand on this, I will touch briefly on the third quarter performance. As you have seen, overall sales were broadly flat if you exclude the sales from Zantac from the same quarter last year. Without Zantac, we've seen good momentum in most of our categories in Q3. And particularly, in the U.S., where allergy sales were very strong growing plus 17%. Regarding Zantac, we will remember that the impact of last year's voluntary recall was down in October, and we will return to a more like-for-like comparison basis. I am truly honored to join the Executive Committee, which has been charged by Paul to transform Sanofi. And to preempt your question as to why I have taken up this role, let me briefly remind you of 3 core strengths of Sanofi's Consumer Healthcare business. First, I -- we already are a leading global player in CHC with strong positions in key markets, an existing footprint in China, and our exposure to emerging markets is in a particular strength. Second, we have an attractive portfolio of brands with strong brand equity across all categories we play in, and we clearly have a number of leading brands with still significant sales potential. And third, you have, of course, heard that we have 2 major switch opportunities in Tamiflu and Cialis, which could lift our performance significantly above market growth in the coming years. A major part of my previous experience in the beauty industry has been leveraging consumer insights and maximizing digital and e-commerce channel. I truly believe our CHC business has untapped potential here. We have the opportunity to reach our consumers through cutting edge digital platforms. I also think we need to focus to build true hero products and leverage strong consumer innovation. In other words, I can see major opportunities to drive our top and bottom line. Let me stop here. But in summary, I'm super excited to be here, and I see really promising outlook for our CHC business. And I very much look forward to sharing my plans with you at our upcoming investor event. With that, I'm handing it over to our CFO, Jean-Baptiste.
Thank you, Julie. It's a pleasure already to work together. On Slide 16, company sales increased 5.7% in the third quarter. We delivered another quarter of P&L leverage, driven by further efficiency. Consequently, BOI grew by 9.2% and our BOI margin increased by 30 basis points to 39 -- to 31.9% in the quarter. Turning to gross margin. We saw a 50 basis point reduction in Q3 to 70.9%, which is consistent with the outlook we provided in July. As you may recall, second half gross margin is typically lower than the first half due to vaccines, and this will be particularly evident in 2020 due to the record sales of our flu products. In addition, we continue to see an underlying mix of gross margin tailwinds from productivity gains on Specialty Care sales growth, which are more than offset by the anticipated headwinds from pricing reductions in China and lower U.S. diabetes sales. As mentioned, we continued to deliver meaningful efficiencies in the quarter with SG&A and R&D, both broadly flat versus the prior period. Among the other line, I would highlight other priority income and expense, which increased significantly versus the prior period. The main reason here is a higher outflow associated with the Regeneron monoclonal antibody collaboration. This outflow increased in the quarter to EUR 229 million compared with EUR 206 million in Q3 2019. As you know, this is a net figure, which includes 3 components: the share of profit and loss to Regeneron, reimbursement of commercialization expenses incurred by Regeneron, and reimbursement by Regeneron of our development costs. When we look more closely at OpEx on Slide 17, combined SG&A and R&D spend increased by 0.4% in the quarter and by 4.7% in the first 9 months. The overall takeaway message is that we continued to lower operating expenses to fund increased investment in our key growth drivers via resource reallocation. In R&D, we had previously guided to H2 2020 expenses to be in line with H2 2019. This is indeed what we saw in the third quarter, with the trends from our discontinued diabetics and cardiovascular programs, reallocated to our priority assets as well as our recent incremental BD on M&A activities to strengthen the pipeline, such as Synthorx. A proof point of this is our ability to start 7 new Phase III programs without a meaningful change to our R&D spend. For SG&A, our smart spending initiatives helped to lower expenses slightly in the quarter, while investing in Dupixent on flu vaccine DTC companies. Overall, I'm very confident that we remain on track to meet our BOI margin target of 30% by 2022. On Slide 18, we summarized the pushes and pulls for our different businesses for Q4. In pharmaceuticals, we expect new patient starts in Specialty Care to be around 80% to 90% of pre-COVID levels. General medicines, we expect the impact from U.S. diabetes rebating on the COVID environment to be partially offset despite growth in China. In vaccines, increased flu and PPH sales are expected to be partially offset by travel, adult boosters and meningitis vaccines. In CHC, we expect to see similar dynamics to what we have seen in Q3 as well as the annualization of the Zantac withdrawal. On OpEx, we will continue to deliver further efficiencies in SG&A, while R&D spend in the second half is likely to be similar to the second half of 2019, as I've mentioned before. On my last slide, we are raising our full year guidance for 2020 business EPS. We now expect this to grow by around 7% to 8% at CER, an improvement of 100 basis points compared with our previous guidance. The increase reflects a strong performance in the first 9 months, together with our expectations for the various headwinds and tailwinds in the fourth quarter. When we turn to foreign exchange, the impact is expected to be negative by 6% to 7% based on October average exchange rates. This compares with the estimated currency impact is then related with our second quarter results of between minus 3% and minus 4%. On the Q4, we expect it to between minus 11% and minus 13% is ForEx impact. I now turn the call over to John. John, to you.
Thank you, J-B. The challenges of the coronavirus pandemic notwithstanding, Sanofi continues to make rapid progress advancing our pipeline. A lot has been accomplished since our last update at the Q2 earnings call, as illustrated by this slide. It's just 1 month ago, we completed the acquisition of Principia, which brings us full control of tolebrutinib, our brain-penetrant BTK inhibitor as well as adding another BTK inhibitor, rilzabrutinib to our pipeline. We are also moving fast to initiate 6 additional Phase III programs, including our oral selective estrogen receptor degrader 859, which we now call Amcenestrant in combination with palbociclib in first-line metastatic breast cancer, plus 3 new indications for Dupixent. A Phase III study to evaluate rilzabrutinib in patients with immune thrombocytopenia is about to open. And finally, we plan to initiate a Phase III program for our anti-IL-33 antibody. [Audio Gap] We have shown scientific leadership in our efforts to develop efficacious and safe COVID-19 vaccine candidates in this pandemic. We believe Sanofi has one of the most advanced adjuvant recombinant protein-based COVID vaccines in the industry, and we're excited to announce today that the Phase I/II trial has fully enrolled, and we anticipate results in early December. In addition, we have also fully enrolled the Phase Ib study of our partnered RIP kinase inhibitor as a potential novel therapeutic approach in hospitalized COVID patients. If I start with the Principia acquisition on Slide 21, we are moving full steam ahead with tolebrutinib in multiple sclerosis. All 4 Phase III trials are open for enrollment. And meanwhile, we have achieved an astonishing 98% patient retention rate in our long-term extension study coming out of the Phase II trial. While we continue to collect data on relapses in the long-term extension study, we know that meaningful data will require longer, larger Phase III trials. Beyond MS, now with full ownership, we have the possibility of evaluating additional neurology indications for this exciting brain-penetrant BTK inhibitor. The acquisition also adds the reversible covalent BTK inhibitor rilzabrutinib to our late-stage pipeline. Here, Phase III development is underway in the autoimmune dermatological condition, pemphigus, where we expect NDA-enabling data in the second half of 2021. Another Phase III is starting for the blood clotting disorder, immune thrombocytopenia, building on promising Phase II data. Both pemphigus and ITP illustrate the utility of BTK inhibition in auto antibody-driven diseases, which is a broad class of disorders that spans rheumatological, dermatological, hematological and neurological indications. Additionally, a Phase II study in the autoimmune condition IgG4 disease has also been initiated to test additional BTK relevant mechanisms as a potential gateway indication to several other autoimmune disorders. Given the strong rationale for the BTK target in many allergic and autoimmune diseases, we anticipate a broad program for rilzabrutinib and will provide updates in the future. On Slide 22, we provide a brief update on our 2 exciting wholly owned oncology agents, Amcenestrant and THOR-707. The news on our oral SERD, Amcenestrant is that we are starting the AMEERA-5 pivotal trial in first-line metastatic breast cancer in combination with palbociclib. The data that set the stage for this Phase III pivotal study were generated in our Phase Ib trial of AMEERA-1, which we plan to present at a medical congress next year. As a proof point for our commitment to moving with much faster pace, the time from the last data cut to decision to start Phase III was less than 1 week, and the trial was now open for enrollment, less than 1 week since taking that decision. As we've previously communicated, we think our molecule has the potential to be the best-in-class oral SERD. Biomarker data presented at ESMO support our hypothesis that Amcenestrant results in almost complete estrogen receptor degradation while displaying a very benign safety profile. We continue to collect data also in the neoadjuvant setting to prepare for future adjuvant studies of Amcenestrant in early breast cancer. And finally, our pivotal study of Amcenestrant monotherapy in second- and third-line metastatic hormone receptor-positive breast cancer, AMEERA-3 is expected to read out in the first half of next year. It's an event-driven trial, so the precise timing is uncertain. Now switching to THOR-707, one of my favorite topics, I hope you all saw the news of our agreement with Merck, under which we will investigate the combination of our non-alpha IL-2 molecule with Merck's KEYTRUDA in various cancers. We are told that this represents Merck's most extensive collaboration of any novel immuno-oncology drug combination, which is a nice endorsement of our view that THOR-707 has the potential to deliver a best-in-class profile for an engineered IL-2 molecule. In terms of development, we expect to move THOR-707 into multiple parallel Phase IIa signal seeking studies in the first half of next year once we have aligned on a recommended dose for our ongoing Phase I monotherapy and Phase Ib drug combination studies. On Slide 23, we move from oncology to respiratory, specifically chronic obstructive pulmonary disease, COPD. Dupixent has shown evidence of significantly improving lung function in COPD patients that have high levels of circulating eosinophils, namely a subset of COPD patients who have type 2 inflammatory component to their disease. 2 Phase III studies are underway with Dupixent in COPD patients having an eosinophilic phenotype with results due in 2023. Now what's new since our last update is that we have decided jointly with our partner, Regeneron, to advance our anti-IL-33 antibody, now dubbed Itepekimab, also into pivotal studies for COPD. This may come as a surprise to you given the previous clinical findings of the IL-33 class of biologics in other indications. However, in a Phase II study of a diverse population of COPD patients, we identified a potential responder subpopulation in the prespecified subset of former smokers. Those data will be shared via publication or in an upcoming congress. In moderate to severe COPD, epidemiology evaluation suggests that roughly 70% have quit smoking and various molecular studies have illustrated differences in the biology of COPD and former smokers compared to active smokers. Our Phase II data show a striking effect among former smokers in exacerbation reductions and lung function improvement regardless of eosinophil levels. We plan to start 2 parallel pivotal Phase III trials and expect to have sites activated possibly before the end of the year despite the challenges of the ongoing pandemic. The readout will likely be 2024. All together, Dupixent and Itepekimab address roughly 80% of the moderate to severe COPD population, which defines an exciting opportunity for us at Sanofi to lead the field of the use of biologics in COPD, a disease that ranks among the top 5 leading causes of death worldwide. Now if I move back to Dupixent on Slide 24. We previously talked about leveraging our real-world evidence platform and external case study evidence to identify and prioritize unmet needs in the type 2 inflammation space. By utilizing this approach, we have aligned on 3 new indications that each impact quality of life and that we believe are worthy of study with Dupixent. One is a dermatological condition, chronic inducible urticaria; the other 2 are respiratory conditions, namely chronic rhinusitis without nasal polyposis and allergic fungal rhinosinusitis. In each case, we will begin a pivotal Phase III trial this quarter and if successful, we do expect to make regulatory submissions in the 2022 to 2023 time frame. On my final slide, let me close by looking forward to 2021, when we're going to keep you busy with proof points of our priority molecules and our other pipeline programs. With the inclusion of rilzabrutinib in pemphigus, we are now looking forward in 2021 to the results of at least 9 pivotal studies. Among these will be the readout of our SERD, Amcenestrant in second and third-line metastatic breast cancer, as well as the much anticipated Phase III results of our 2 key hemophilia therapeutics, Fitusiran and BIVV001, the readout of Dupixent in chronic spontaneous urticaria is also going to be very important for us, given the size of that dermatological indication. And it goes without saying that the entire world will be eagerly watching for the readout of our coronavirus vaccines. When we turn to Phase II readouts, I'm especially excited about venglustat, our pipeline and appeal for rare and not so rare diseases, where we expect the important results in our fully enrolled GBA Parkinson's study, which is an opportunity for us to potentially pave the way for the world's first disease-modifying therapy for Parkinson's. And as mentioned, we are currently working on our Phase II plans, especially for rilzabrutinib and THOR-707 and we'll share those externally next year. We also plan to refresh our pipeline in 2021 with multiple first-in-class, best-in-class NMEs plan to enter the pipeline and into the clinic next year, including some from our nanobody platform. So we expect 2021 to be a news-rich year for the Sanofi pipeline as we continue to execute on our strategy. With that, I hand it back, Paul.
Well, thanks, John. And as usual, you leave me inspired with the innovative thinking, the cutting-edge science as we leverage to literally change the practice of medicine. I think things that shouldn't be missed, by the way, in John's comments, are the speed, speed from last look at data to decision to open for enrollment, a covered 2-week period covered that. That says something not only about the company we're becoming, the standards we set, but also importantly about what is possible to do during COVID. I'm very proud, by the way, of everything we're doing in the company. But our trial work and indeed our manufacturing, which is here in France, almost 100% at capacity. So we may surprise everybody with the resiliency that I talked about earlier, the portfolio and how well it's balanced and the opportunity in this great company. So to summarize the quarter, we made excellent progress in the transformation of Sanofi through our Play to Win strategy. As mentioned, we delivered solid, strong sales and EPS growth, which underscores the strength of our business in this difficult environment and allowed us to raise our full year guidance. Our performance was driven by the strong momentum and leadership of Dupixent across age groups and geographies as well as a record flu performance, which we think is a leading indicator of increasing immunization rates going forward. Taken together, I'm proud of what we've achieved in my first year as CEO. And whilst we still have work to do, I'm confident we are absolutely on the right track. So with that, why don't we open it up for Q&A.
We will now open up the call to your questions. [Operator Instructions]
[Operator Instructions] The first question is from Graham Parry from BofA.
So firstly, on flu, could you just remind us that the provisions that were taken against non or return sales last year, has any of that been written back? And could that benefit Q4? And how should we think about moving into next year? Or do you still expect to see similar levels of demand growth as we've seen in 2021? And then secondly, with days away from U.S. election, obviously, and perhaps you could just update us on your thoughts of both the industry and Sanofi's ability to work with the Biden administration in terms of preserving incentives to innovate in pharma?
So thank you, Graham. We'll start with flu, maybe, hand to Thomas, and then I'll comment a little bit on where we stand the week ahead of an election.
Thank you, Graham, for your question. So a couple of points in your question, maybe for those that are not completely familiar, but the process first on how we do treat flu regions normally. Each year, as you know, we book a provision to cover the flu return of the ongoing campaign. So that's an accrual book all along the campaign. Based on the actual return, then the true-up of the accrual is usually performed in Q3, okay? However, exceptionally this year, due to the COVID-19 context and the less return by the physicians from last year, we'll do the true-up only within the Q4 quarter and not in Q3. We expect, however, to have pretty much invisible impact in Q4 to tell you where we are today, Graham. Now moving forward for the second part of your flu question for 2021. It's clear that we are seeing very well right now that prevention is extremely important. Therefore, we expect a strong this year in the NH 2020 season, for the current season. And I will expect, overall, a very good uptake of the doses that we are putting into the market. Having said that, as you have seen, we are, for the first time ever, provided a 0.25 billion dosage into the market, and it will require immunization to occur until the end of December.
Thanks, Thomas. In answer to your question about the upcoming election. I mean, well, let's wait and see what happens next week. I think we know a few things for a fact about our own company. We know that we have a good balanced portfolio in the U.S. We mentioned earlier our exposure in Medicare, Medicaid. We referenced the Dupixent, majority, 70% of the business in the commercial channel. We are more than prepared to demonstrate our value, whatever the administration and will bring our very best to that. So we look forward to finding out what happens next week. But as you'd imagine, we prepare for all cases.
The next question from the phone is from the line of Wimal Kapadia from Bernstein.
Wimal Kapadia from Bernstein. So just coming back to the full year guidance. Sorry for the detailed question, but you did EUR 4.64 in business EPS for the first 9 months. And if I take the midpoint of your guidance and the FX assumptions, we are looking at an EPS for the full year of around EUR 5.7 at the midpoint, which would suggest around 1.06 business EPS in 4Q. So now even when I factor in the very painful FX assumptions you just outlined for 4Q, that would still represent minimal growth in constant exchange rate year-on-year for 4Q, or possibly even a declining earnings in 4Q. So are there any one-offs that we should be aware of? Why are you just being super conservative? And then my second question is just on the Principia acquisition, now that it's closed. I wondered if you could give a bit more insight into rilzabrutinib? I mean the Phase II in pemphigus looks really, really compelling. So I just wanted to get your expectations heading into the Phase III readout in the second half of '21. And just to get a sense of your level of confidence for this indication, given we've seen such good Phase II data.
So thank you for your comment about your anticipations for Q4. I'll let Jean-Baptiste comment. There are some unknowns, of course, how things will play out in terms of rolling lockdowns and other things, but Jean-Baptiste.
Well, I love your question, honestly, because overconservatism on a quarter like this, it's nice because I hope that you don't find our delivery conservative. Now we want to deliver on -- at our best on each quarter. What we see is some unknown, of course, in Q4, you know that we might have less elective procedures with lockdown starting up again in Europe. We see less traffic in pharmacy, but the overall picture is very good because we have a resilient business, and we have a strong team and we are fully confident that we will deliver. And we are not expecting one-offs, we are expecting to deliver strongly as we have delivered so far, but in a very uncertain context for Q4.
Yes. And I think it's also worth adding is that script data that's available in the U.S. shows that we started October in reasonable shape, and certainly on the major growth drivers. So we look forward to reporting out in these results when we have the actuals. John, I'm going to come to you on Principia, and in particular, rilzabrutinib, but just to remind everybody, and we said this at the time, I think, on the IR call, we're really excited about tolebrutinib and what it could do in MS. And of course, we wanted to have all of the economic rights because it makes sense to be less encumbered going forward, particularly with the excitement around that medicine. But as we got into the diligence, of course, we got increasing confidence on rilzabrutinib and what it could do. And that got us equally excited and the exquisite chemistry that went on to create different BTKs, but John, I'll let you give a comment about what excited you. And maybe you could comment on the number of patients that remain in the open-label extension at tolebrutinib.
Sure. Yes. Thanks, Paul. The -- we're very excited about the Principia portfolio of tailored BTK inhibitors. Tolebrutinib, of course, we've been talking about since the last Capital Markets Day, and we're full steam ahead with that. The open-label study, 98% of the patients have stayed on drug, and we're eagerly collecting data on them and doing other studies in all 4 of the Phase III studies for the pivotal stage for MS enrolled. Now the question was specifically though about rilzabrutinib. We're very excited about this molecule. The reversible covalent nature of this molecule we think provides a best-in-class profile where the covalency aspect of it gives best-in-class potency while the reversibility gives best-in-class safety, we believe. We've seen a very well tolerated medicine. The Phase II data in pemphigus were nothing short of stunning. Similarly, very promising data in immune thrombocyopenic purpura, ITP, those are both very clearly auto antibody-driven diseases where the immune system is making antibodies that attack certain tissues, in one case, the skin, the other case platelets. But to see such stunning data in both indications, clearly has validated the hypothesis that BTK plays a pivotal role in these autoantibody-driven diseases. And that's a broad category of disorders that we tend to fully exploit over the next several years. So we're very excited. We're also excited to see that how rapidly the pemphigus patients improved, which validates one of the mechanistic aspects of rilzabrutinib and BTK and probably suggest that what we're seeing is that important role that BTK plays in the signal transaction by the FC receptors. So that's, I think, something that we were delighted to see out of those data and suggests a very broad and important new mechanism for combining autoimmune and allergic diseases going forward.
John, I'll just mention, I think I posed a question, but just to keep us moving that almost 100% of patients stayed on tolebrutinib, have stayed on tolebrutinib at the high dose in the open-label extension.
Your next question from the phone is from the line of Peter Verdult from Citi.
Pete Verdult, Citi. I have 2 questions, please. On China, just latest thoughts on when you might get NDRL listing for Dupixent? And then separately, just can you share with us again how you're thinking about Plavix and Avapro beyond 2020? And we all know what's going on this year with VBP, but when we think about 2021 and beyond, is this a return to growth scenario that you envisage? Or something where every couple of years, we get a new VBP program to sort of step-wise decline? And then secondly, for Thomas, on COVID, what are the implications for your planned Phase III studies if we do see positive efficacy data from other sponsors before you start? And I'm asking that question in light of some of the commentary coming out from last week's FDA advisory committee meeting. So do you still think you'll be able to undertake placebo-controlled studies in this scenario? And if not, how would you manage crossover risk?
Okay. Peter, thank you very much. Bill, it's a good question. The question I'd like to ask is to, Bill, when will we get [ GP ] NRDL in China?
Well, thanks for the question, Pete. We've been very impressed by the changes that we've been seeing in China. First of all, just the unprecedented time for approval and then our unprecedented time to launch. So things remain always possible in China. And we are certainly doing everything that we can to see if there's a way to actually be successful this year within NRDL. Again, that's -- we're going to plan and look to see what's possible. However, we don't have certainty on that yet, so we'll see how the process unfolds. But our long-term prospects in China, as we've stated before, we expect this to be blockbuster status there in time. We think the opportunity is great. And as I said, the environment within China is making that possible, so more to come.
Thanks, Bill. I think we were approved in 25 days or something like that in terms of made available. So we really do hope to be listed within a year. It would be a tremendous achievement. Maybe Olivier, to give us an update for what you see going forward for Plavix and CoAprovel in China.
Peter, thank you for your question. Of course, we are very happy with our performance, and we think that we made the right decision in terms of participating into the VBP last year. When we are looking ahead, the situation is a little bit different for Plavix and Aprovel in terms of potential for growth in 2021 and 2022. In 2021, for Plavix, the molecule is currently growing year-to-date 13%, and we believe that it will stabilize at around 10% or 11% next year. I'm talking here about the total molecule. We think that we will stay at par with the market. So in other words, we think that there is still potential for growth for volume in China in 2021. I would add one element, which is important, the split between hospital and retail has changed significantly after the implementation of VBP. And now we have only 75% of sales that are made through hospital, which means that the retail segment, and we are -- there is a lot of stickiness, has been increasing sharply. And so for Plavix, a significant growth in 2021. For the Aprovel family, it's a little bit different in terms of volume growth here, the market is stable, even slightly declining. So what we have in mind is that the market in 2021 and 2022 will be stable, maybe a little bit declining. On your question more specifically on VBP and what's going to happen in 2021, 2022. The VBP was built on a 2-year contract and with the possibility to be renewed for an additional year, which means that in 2021, of course, we are not expecting any further price decrease. In 2022, the extension of the condition of the extension and what would be the impact have not yet been disclosed by the authority.
Thanks, Olivier. And I remember, it was my first earnings call last year where we sort of introduced the VBP and the impact. And I have to say, kudos to Olivier and the team in China, we called it absolutely right. And likewise, the growth in volume. Maybe, Thomas, on the complexities as other companies bring forward data with COVID-19, where does that leave us, particularly in executing on the study.
Yes, Peter. So when it comes to doing the COVID-19 Phase III vaccine development, we're indeed looking at the FDA outcome and looking at the different scenarios. We believe that we have a very good plan, but we'll be activating a large number of countries and sites based on the few things, of course, the potential availability of other COVID-19 vaccines, which is something we are, of course, anticipating, planning and taking into account as well as the operational feasibility of activating all those sites. So what we are targeting is probably doing a Phase III of more than 10 -- in more than 10 countries in order to avoid that risk. This is, of course, something we've been discussing, as you can imagine, and planning with operation [ team ].In addition, it's also important to note that we will be leveraging predictive analytics regarding COVID-19 epidemiology to ensure that, of course, we reach recruitment targets and the study outcomes as rapidly as possible. Our goal, as mentioned before, is to come to market towards the end of the first half of 2021. And therefore, we are actively monitoring the situation for COVID-19 epidemic.
The next question is from Richard Vosser from JPMorgan.
First question on the SERD. You've obviously gone into the Phase III trial very quickly, the AMEERA-5 trial. Could you just give us some insights on what you've seen in terms of the combination efficacy with palbociclib, and how that looks relative to the competitors that's given you that confidence to move fast? And just aligned to that, you've chosen palbociclib the standard of care, but how should we think about the adjuvant setting, of course, a different CDK4/6 is going to be probably taking that market? And then secondly, just coming back to the guidance. It does seem to imply quite a large SG&A increase, which seems unlikely in the current COVID environment. Just maybe Jean-Baptiste could talk about thoughts for SG&A and the cost base in Q4 and going forward?
So thank you, Richard. Our SERD, of course, now known as Amcenestrant. So let's try and use that going forward. John, over to you on what data, I'm not sure what we've shared, so choose your words carefully. And then whether this is the right combination given other potential combinations in the adjuvant setting.
Yes. Thanks, Paul, and thanks for the questions. Of course, we're very excited about Amcenestrant for the -- and that's why we featured it in this report. The data that gave us the confidence to move forward will be presented at a congress next year. We're not going into details. But clearly, we continue to see the signs of efficacy and best-in-class safety that gave us the confidence to move forward, including in combination with palbociclib. So that's probably about all I can say for now. With respect to the adjuvant, you raised a good issue about whether the CDK4 class will become part of the paradigm for that and for which patients the [indiscernible] in the high-risk patients suggest that, that may become one of the standards. And so we'll be factoring that in as we develop our plan around the adjuvant therapies, where in advanced discussions with some of the cooperative groups about what that might look like. And we'll be exploring maybe more than one way of approaching the adjuvant space going forward.
Thanks, John. Jean-Baptiste, we're getting the second sort of question this time from Richard a little bit around trying to calculate the final quarter and the potential increase in SG&A. Do you want to add any additional color?
Yes. First, it please me that Richard is asking it. No, we're not looking at anything special, but going on, making room for more science. And of course, going on driving growth behind our growth [indiscernible]. So no worries on that front. So many efficiencies to unlock, so many opportunities in Sanofi. That is just the beginning of improvements, which will allow us to deliver on our plan. So no worries for Q4.
The next question is from the line of Geoff Porges from SVB Leerink.
This is Geoff Porges, and thanks for all the color on the call. First, could you just clarify what your expectations are for your increased supply of flu vaccine next year? And do you expect this vaccination rate to persist? Secondly, Paul, you somewhat ominously said uniquely positioned to take on what is ahead of us. And I was just wondering if you could clarify for us what that means? And then just another vaccine question, which is, could you give us a sense of your share of infant vaccinations. You talked about the overall market trend recovering. And can you talk about your share and where that might go to in the future, there was nice growth in that line.
So the last question is vaccine, sure?
Yes. Geoff, thank you very much. I'll hand to Thomas. Before I do that, on the ominous comment, I meant, it really was then a poor choice of words on my part. I think what I was trying to do and we'll continue to try and do is to remind everybody how well positioned we are as a company. I mean I watched through the earnings season, I watched everybody else, I looked at all the narratives. And yet, I look at our results and they stand strong on their own. And I think we have the right portfolio. I mentioned that Dupixent growing 69% quarter over last year. In turn, when many other innovative companies are struggling, struggling in the dermatology office, let's be honest, to get new patient starts. And yet, I feel somehow our progress made is a little discounted. So I like to reassert wherever I can, that we are well positioned with a broad portfolio, with high-performing growth drivers, with a laser-guided cost control and still advancing the pipeline. And it's early maybe in people's understanding of -- was still a show-me story, but I'm a year in and I can tell you, we're ahead of where I thought we'd be despite the challenges externally. So maybe, Thomas, to you, on how big the flu season will be in 2021 and the relative performance of the company.
Okay. So first of all, regarding flu, indeed, as we've seen, as we have seen, sorry, currently, prevention and therefore, the place of vaccination is extremely important. A couple of things because we need to look at it, I think, in both volumes and value. As I mentioned to you, when we look at the influenza slide before, it's extremely important to look at the fact that the market is going towards differentiated flu vaccine. And Flublok and [ Efluelda ] are the only 2 clinically differentiated flu vaccines. We do see the expansion and the growth of different set of vaccines to keep growing in the coming years. So that's for the value path. And we have planned, of course, for the capability in terms of manufacturing to sustain that growth. In parallel, from a volume perspective, it's also very important to remind to ourselves what is the current level of vaccine coverage rate. And we do see still some rooms. It's very interesting to see that not only, for example, if you look at the U.S., about 70% of U.S. elderly are being vaccinated against influenza, meaning 30% are not. But if you look at what's going on in Europe, for example, this year, we are seeing expansion of flu recommendation in Europe, where the actual current coverage rate is lower, but we are seeing expansion into new aged groups, which is very good moving forward. We think it's towards a good direction. Again, similarly, if you look at the rest of the world, for example, China, but other markets, you know very well that the vaccination coverage rate against flu there are very, very low. And therefore, I see a significant improvement possible for vaccine coverage rate improvement. So that's really a strong pillar today, but I believe a very strong pillar for tomorrow. Now when it comes to the overall, I would say, flu -- sorry, overall vaccines position, if I understood your second question properly, Geoff, I think you were referring to how well are we positioning versus the other. I think it's interesting to look at the fact that we are not only a flu U.S. performance. I didn't highlight that. But I said that in this quarter, we are expanding to by more than 50%, well, actually, it's more than 50% increase in U.S., more than 50% increase in Europe and more than 50% increase in rest of the world. So that's all over the geography. In parallel, I think it's very important to look at the performance of our pediatric franchise. As you have seen, we are growing. And I invite you to look at the reference of our different competitors. We are the only one growing in that segment. So I think that's showing also how well we are doing in this important second pillar of performance, which is pediatric portfolio. And then, of course, it's also interesting, even though sometimes we are a bit comparing apples to bananas, but you're looking at the overall vaccines performance. If you look at where we are versus competition, I think on the first 3 quarters all together, the Sanofi Vaccines division is providing a plus 6% performance on 9 months. I think it's a positive one. It might not be the case for the other vaccine multinational companies. I think we want to keep on that trend, but very important for us.
The next question is from Laura Sutcliffe from UBS.
A strategic question for Paul, please, on how you view the long-term future of the rare diseases business. Can it persist as it is? Or do you see a pressing need to introduce any more new modalities alongside the established franchises that you have? And then secondly, on your recombinant protein COVID vaccine, the Phase I/II trial design says that you're testing, both with the GSK adjuvant and with your own, is that because the goal is ultimately to in-house the entire project?
Okay, Laura. Maybe I'll throw this to Bill, but just a quick comment upfront on rare diseases. We're incredibly proud, by the way, the history and the Genzyme piece part of Sanofi Genzyme, I think we still do incredible work. It's a growing business. Let's not miss in the mix that venglustat which is -- got some readouts next year, including, by the way, GBA Parkinson's. We really believe that we could have a small molecule in the rare disease space on top of what we're doing with the nanobodies and avalglucosidase and the rest of the current lineup and launches. And it's -- it could be game-changing for that group. And I think we're, perhaps, by the way, the best company in rare diseases. And then a little further out, of course, we have the gene therapy work that we're doing across a number of rare diseases and we've shared that at a previous meeting, I think, our strategy around that. But pretty excited about what it means. As you'll remember, these are low infrastructure investments, but incredibly rewarding for patients. And we have some brilliant science that supports it. Bill, would you like to add anything?
No. I think that's right. Look, we are the leaders in this area, and the business has performed very well as you see. Year-to-date, we're at plus 7%, which is in line with our mid-single-digit 2020 expectations. And as Paul said, we have some, we think, exciting products that we're launching. I think, from our perspective, we look and see where is the unmet need, and then what would be the right approach to fulfilling that unmet need, whether that be enzyme replacement or another technology as Paul highlighted with venglustat. And ultimately, some of our gene therapy efforts. So we think that this is -- remains a high unmet need area. There's a lot of rare diseases that have no solutions. They are rare, but that doesn't mean that they're not devastating diseases for those who have them. So we'll continue to pursue and follow the biology and provide solutions there. It's an exciting area that we've been in for a lot of years.
Yes. Thanks, Bill. And just remind everybody, I think we are at 7% growth, I think, coming through Q3 in rare diseases, which is perfectly in line with our expectations. And given the complexities of starting new patients and everything shows you what we're able to do virtually and in cooperation with physicians. And a little point, again, I may have missed is the fact that all our enzyme replacement products are now available in China. And I think that's also something not to miss as the health priorities swing into action there. Thomas?
Yes. When it comes to the recombinant protein COVID-19 vaccine development plan, what was very important, of course, is to have impact on the disease. And the second part, of course, what we do for each plan is to look at the site. And -- but for these 2 reasons, that as you have mentioned, in the Phase I, Phase II, we have 2 adjuvants because you know that we have our own adjuvant center, and we are moving our own adjuvant program and portfolio. But we want to have impact also, which means that we need to go fast because this is a pandemic period. And getting fast-to-market is very important. And the fact that our flu protein platform was already licensed as well as the GSK-adjuvant platform being licensed in various markets is actually the best way in terms of speed and the effort and testing to market. So with that in mind, that's why we developed it with those 2 arms. But moving forward, we are committed to go with the GSK-adjuvant platform for the Phase III for the matter of being impactful against the disease, and that's really the primary outcome there.
The next question is from the line of Jean-Jacques Le Fur from Bryan Garnier.
First one is on Dupixent. After a very strong performance during the first 9 -- sorry, 9 months despite the COVID pandemic situation, how do you view the consensus for the full year at EUR 3.5 billion? Too high? In line? Or below your expectation? Or where it could be really after this first 9 months? And second question is regarding, once again, sorry about flu. Some of your -- one of your competitors alluded today that flu vaccination may continue in beginning of next year, which is an unusual period for flu vaccination. Do you share such a view? And if yes, would you be able to provide a flu vaccine in January, February, which is once again unusual for this type of vaccination?
Okay. Thank you. Maybe we'll start with flu.
Thank you for your questions. So I share in the previous call that we said from one of our competitors on the fact that it's possible, but that will be increased now the vaccination in January and February this next year. This is a good thing because if you look at the past 20 years, the vast, vast majority appears -- the peak of the epidemiology was during the month of February and March. So actually vaccinating in January, from a medical perspective, is not a bad thing at all and much better than the vaccination. So it's very well possible that we could see a little bit more of January vaccination than usual. The good news is that with 40% market share roughly of the influenza worldwide market, we have significant capability to deliver value. As we have said before, we have about 0.25 billion doses that we plan to ship this year. We believe that some of the shipment, I've mentioned before, will happen in November and December, and that's why we have a different spreadout between Q3 and Q4. And we believe those shipment will be very important, actually, and we'll spend those all over the world to make sure that it covers potential vaccination that could actually happen.
Thanks, Thomas. I think I would add, and I think the question came up a little bit earlier around will this new record flu season, is it something that could be sustained on the outyears? And there's a mixed history of that after H1N1 and other things. But I think, for us, what's really interesting for me, particularly as well, is that a lot of people are getting a flu vaccine for the first time, who never really got around with it. I think we're opening up to a new sort of treatable population, if you like. You've seen how easy it is, how convenient it is and the peace of mind. And I think we may see a different shape going forward. And for us and for me coming into the business, to see that the potential for flu may be significantly more over the coming years than we expected, given how well positioned we are with differentiated vaccines, market share is pretty incredible. Bill, I'll leave it to you to dodge the question on Q4 as expertly. But we have to accept that maybe you could add some more color that we're doing in dermatology offices what really know at the derm product in any of the derm company is able to do.
That's exactly right. And as we started off the call, we are extremely confident about the greater than EUR 10 billion peak that this product is going to have. This is a great product. It is just a product that we -- having been in the industry a long time, never worked on anything quite as exciting as this. And the reason why it's because the biology is fundamental to type 2 diseases. That's what we're focusing on. We take -- if we look at the 2 key indications with atopic dermatitis, we now have greater than 200,000 patients which is really quite a remarkable number to think about when you think that we've been on the market for just 3 years now. And it's because that profile, the efficacy is best and the safety is best. And as we look at the -- specifically in atopic dermatitis, people are looking for efficacy, but dermatologists are extremely safety conscious. And as we continue to generate long-term data, we presented 3 year data on the safety coming up at EADV, which shows that it maintains its safe profile. And when we look at the asthma indication, we believe we've got the best profile there as well. Remember, that about 80% of the asthma population is type 2. And we are fundamental to type 2. So we really believe that we're going to continue to grow and exceed that EUR 10 billion number. So nothing on Q4 other than all the indicators are positive towards the brand. Despite the challenges of COVID, we've been able to continue to grow the brand. And there's really a lot to look forward to this as we increase our geographic spread in new indications. So I'll leave it there.
Yes. Thanks, Bill. I mean it's still -- listening to how other medicines have struggled in the derm's office. A lot of it, of course, is about execution at Sanofi, but as Bill said, this medicine is very special. And the profile that it has is really, at a moment, and we're really proud to be bringing the benefit that we actually have.
The next question is from the line of Brian Tsang from Wolfe Research.
This is Tim Anderson at Wolfe. I have a question on spending levels as we close out 2020 and move into 2021. It seems that during the whole work from home thing, most drug companies have reported results that have commonly been a little bit light on revenues, but they've made it up on earnings through lower operational spend. And one concern I have is that analysts potentially erroneously use the 2020 spending levels as the base and that might be artificially depressed. At the same time, what has kind of struck me as odd sometimes at Sanofi, when new management came in, you talked about fixing things, yet simultaneously cutting cost. And usually, when something is broken, you have to spend to fix it. But my question is ahead of giving 2021 official guidance, can you give us some idea of what OpEx in 2021 might look like relative to the 2020 base? Is it likely to be lower in absolute terms or flat or higher?
So I'll let Jean-Baptiste comment in a second, Tim. We were on our smart spending initiative before I arrived, before COVID, before everything. I think your insight is absolutely spot on. I think as expenses declined through the pandemic, I think some top line misses for a lot of companies have been compensated for by the lack of spending. The discipline that we have is from before and will retain after COVID. You remember, as Jean-Baptiste said, we've started 7 Phase IIIs. And we're absorbing that within our cost base and moving along relentlessly on this journey. And you -- I can't comment about what my predecessors or the new CEOs have said about fixing things. But what I can say is that what you should never miss is the reallocation, a reduction in reallocation. And I think what we're spending our time on is prioritizing. So there's an awful lot, and our new Chief Digital Officer would tell you, given the overreliance on third parties and the opportunity that we have there, that there is a lot of spend that will -- that we're not taking from the top line, but that can be reallocated to future growth and still allow us to deliver on this overall cost reduction. The discipline on this led by Jean-Baptiste is unlike anything I've ever seen before. So whilst other companies may have got a little bit fortunate just because it stopped organically, this is a disciplined active program at Sanofi. Jean-Baptiste?
Thank you, Tim. Because what you express is belief that you have first to spend more to fix things is very common on widely spread. But if we are here with the team with the Excom team is not to do the expected, but the unexpected, which is to fix things by reallocating and not by first spending more. So don't worry about especially the price cost base in 2020 because of COVID that would rebound. No. That's not the way we do it. We are really changing structural things within Sanofi. And the mindset is not just to deliver what is normally expected. But to do something a bit exceptional it's much more fun. And we are here and committed to deliver it.
That last point, by the way, is a really critical point. We're changing the structural drivers of cost, whereas I think a lot of our peers are benefiting from the discretionary spend that has clearly calmed down in that piece, but the fundamentals mean that it's durable for us, we'll see where we don't worry about anybody else, we'll just do what we do, but we know how to do this.
I'm sorry, this is the operator. I cannot see the next question. Just hold on a second, please. I will go ahead with the next question, sir, I'm sorry. It's from the line of Thibault Boutherin from Morgan Stanley.
I would just like to come back on your comments around flu vaccines and the uptake of differentiated vaccines. If we look at the situation ex U.S., I think historically, a lot of governments have been a bit reticent to give access and reimburse. So could you just give us some color on how the conversation is evolving on this front? And second question, still related to this, could you give us an update on the Kaiser Permanente study? Are you still expecting an interim analysis around the end of this year? And is there anything you could share with the market in coming months?
Okay. Thank you. Maybe I'll just share some of the anecdotes that I've had around the differentiated flu vaccine, particularly high dose and then throw it to Thomas. The number of incoming calls that we've had from leaders in health care and ministries of health around Europe and the world to accelerate the conversations on high dose differentiated flu vaccine has been incredible. In many places, we've skipped forward both in availability. And in reimbursement conversations. What was a little bit of a slow process traditionally because of COVID has really accelerated everything and the determination to understand the value of the high dose differentiated flu vaccine brings has been, frankly, unprecedented and very, very positive. Maybe you should add, Thomas?
Yes. So indeed, the question is about the expansion of differentiated vaccine, as you mentioned. Terrific interest this year. I think, of course, before the vaccine were not available, we were not licensed. So that's the starting point. So we have Supemtek which is U.S. Flublok but as received, as I mentioned before, CHMP post new opinion. So let's expect the registration probably around the month of November or December or coming this year. That's a very important first point. And of course, Efluelda has been accepted moving forward. So the first shipment had happened in Q3 in Europe, and not talking about one country, but in multiple countries, of course, we're starting mostly by Western Europe. I don't expect any big surprise there. And as mentioned before, in link with the previous question on flu, it's very important that we keep this momentum. I think more and more people, as they are getting familiar with the data because it starts with the data are starting to understand what it means at the societal level. So at the overall population level, to have a flu vaccine that is 20% or 30% better and clinically demonstrating in tens of thousands of patients compared to actually a standard flu vaccine. So the most important part is you need to start by adding a flu vaccine. But if you're frail, if you need a differentiated flu vaccine, it has a significant impact on the population level. And that's why we're receiving so many requests. It comes and in a way because, as you know, that we have expanded the facility of Fluzone by adding what we call the Building 79 in Swiftwater that will be coming online starting next year with additional bulk. That's what we are mentioning when we are saying expanding capacity. And that's very important to be able to supply all these markets. So that's the first point. And we're starting to get interest now from ex Europe and ex North America from rest of the world. And that's something, of course, we will keep looking moving forward. So I think the appreciation of the value of prevention is there for respiratory vaccines. And I think the allusion you are making to the difficulty to get payers to be interested is clearly changing, and we think it's a strong trend.
Kaiser?
The Kaiser Permanente study, we've added a third year from this study. So basically, we will expect therefore to have the results 1 year later. And the reason why we've added a third year is because last year was influenced by COVID-19 epidemiology so therefore, we should get the response 1 year later, so probably towards the end of '21 or early '22.
Thanks, Thomas. So as we get a little bit close to the top of the hour, I'm conscious now, we have quite a list and we want to try and keep it to one question only if we can. That would be really helpful.
The next question is from the line of Jo Walton.
One question only. I'm going to ask about the pandemic vaccine capability. You talk about potentially being able to do 1 billion doses next year depending on dose and yields. How much of a stretched target is that 1 billion? If you don't get your -- if it takes you a little bit longer to get approved, would you still be able to sell your 1 billion in 2021? Because presumably, you're making them throughout the year, and you just have a bigger bolus at the time point at which you get to launch? And how could we think about how this would be booked in terms of sales and presumably border income or whatever that you've been presumably getting already to help you fund the build out?
So Tom, over to you, short answers also.
I'll give it a try. The vaccine against COVID-19 capabilities, Jo, it's a bit early to be able to be precise. Clearly, we are targeting 1 billion capacity, as you mentioned. But as you know, very well, we're in Phase I, Phase II. And in order to get there, we have to take oneself to various sites which we have initiated. So we are confident we can get there, but we need a few more proof points along the way. But classically, I will say, process development pathway that we are still going through. And when it comes to booking, same thing here. We're in Phase I, Phase II. So of course, none of that, there's no COVID-19 vaccine influence in the Q3 results that you have seen that we are sharing with you today. Now we will first need to have a positive Phase III results and the registration, and then we will be on our pathway to book sales, but a bit too early to get there in with details.
I think maybe it's also worth adding just very quickly that this is not something that's going to be solved with all the vaccine makers quickly in 2021. So we still have our plan to be sort of May, June next year in terms of the Phase III readout. And we -- whatever doses we have at that point, we're optimistic that all of them would be needed. You know all very well already from everybody else that it's going to take multi-billions of doses to get the world back to a new normal, if you like. And so we're pretty confident actually that all our doses will be needed at some point in '21. And then of course, we have mRNA at the end of next year, hopefully. And that may or may not be needed.
The next question is from the line of Luisa Hector from Berenberg.
So it's on Dupixent. Can you give us a split of the U.S. sales by AD and asthma? And could you give just a little color on where you are in terms of the SG&A investment cycle? Do you have all your reps in place in the U.S.? I mean, clearly, you have a number of indications still rolling out, and also the competitive situation will develop over time. So I just wondered whether we should assume an ongoing ramp in the selling for a number of years to come.
Bill?
Yes. So first of all, for the U.S., we won't give a split between asthma and AD. It's fair to say that the majority of the sales, as we stated in the past, are coming from AD. But again, strong prospects for both the indications. Regarding continued investments. Look, as the product continues to grow and new opportunities present themselves, either in the form of new indications, et cetera, we'll continue to invest in the brand. So we are not at the -- anywhere near the peak of sales, and we have a lot still to roll out. So we'll continue to invest appropriately for the opportunity.
And again, I think probably worth adding that Specialty Care infrastructure deployments are modest. So it's in comparison to what we're trying to do here and how quickly this medicine is growing with discipline, but it's modest. So the team is doing an incredible job.
The next question is from the line of Seamus Fernandez from Guggenheim Securities LLC.
So I really just wanted to focus in on ADPKD and the venglustat opportunity. I think you guys have talked about the opportunity for an accelerated filing on the basis of kidney volume measures, just hoping you could update us on whether or not you've had some -- had discussions with FDA or other regulatory authorities on that potential endpoint. And how enrollment in that study continues, if we're still on track for a potential accelerated filing in 2022?
So I will throw that, I think, to John Reed to give us an update on where we stand on that. It's an interesting question, ADPKD, because it's the first major volume patient population that will get to venglustat, of course, for the Parkinson's readout next year, which, by the way, includes the percentage of non-GBA Parkinson's patients. So there's a significant unmet patient need there, too. So John, where are we -- can you share where we are on enrollment and potential filings?
Yes. Yes, Paul. So the -- we're doing 2 parallel studies or 2 sequential studies. The first one is using total kidney volume as the primary endpoint. That's been fully enrolled. We expect those data probably, I believe, it's going to be early 2021, maybe the first, second quarter of 2021. And the discussions have been encouraging with the health authorities around using TKV, total kidney volume, as an endpoint for accelerated approval, followed then by the functional readout of glomerular filtration rate. But of course, one rarely gets guarantees from the health authorities about these. The Part B study, which is focusing on GFR as an endpoint, is actively enrolling and we expect to have that enrollment probably completed towards the end of this year, I would hope. And then that will lead out probably close to a year after the other one. That's a longer -- it takes longer for that one to read out. So we're hopeful because total kidney volume does correlate very well with the ultimate renal function issue. So we're hopeful, but no guarantees. And my comments really refer to FDA in EMA and Europe and other territories, they're going to really insist on the functional readout.
The last question is from the line of Keyur Parekh from Goldman Sachs.
Paul, just a big picture one. I mean, it clearly seems like you and your team are making tremendous effort kind of in changing the culture of the company in kind of providing consistent kind of execution. And yet the stock prices seem to reflect some of the progress that you've made over the course of the last 12 months. So I was wondering if you might be able to share with us kind of your thoughts on what it is that we might be missing as an investing community, where you think kind of the future kind of value creation opportunities lies in the near term?
Excellent question and a good perhaps place to finish. I've touched on it a few times during the more formal presentation is the fact that I think we're making more progress than people actually fundamentally realize. I have to accept that perhaps some of the legacy view of the company is that we may never move quite fast enough have been told by some of your colleagues that was still a show-me story. But I think, frankly, it's missing the fundamentals of the change that's going on here. We touched on how quickly we're moving drugs through the development cycle. Dupixent, 69% growth in Q3. Proactive cost management, not getting lucky because of everybody indoors. I think we're really doing something pretty extraordinary and at a pace that I didn't imagine and at a time that you would consider the most difficult. The team and the culture that we put together, the team we put together and our fixed -- or obsessive nature on prioritization and reallocation is a real thing. Now why is that not reflected in the share price? You tell me. Maybe it's we're going to have to be -- and I've said this to the team, we'll just keep moving through the quarters, advancing our science, delivering on our expectations and showing people that we're serious. And I recognize that the company has made promises before and not always got there. We're a different company, different Head of R&D, drug development, finance, new leadership in our business units. I mean you look every which way. So yes, I think as we keep showing you we're serious and getting it done, hopefully, confidence will build. And then the buy side and everywhere else, they'll start to see us as a sensible choice. But I feel very good about where we are. And if it takes time for the rest to follow, then that's where it needs to be because we're making exactly the right choices and moving faster than people perhaps externally fully realize. With that, thank you to everybody for joining the call. Thank you for your interest in the company. We look forward to updating you at full year results, I guess, in the early part of next year. Thank you.
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