Yahoo Finance Sanofi (SNY) Q4 2017 Earnings Conference Call Transcript
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Sanofi (NYSE: SNY)
Q4 2017 Earnings Conference Call
Feb. 7, 2018, 8:00 a.m. ET
Contents:
Prepared Remarks
Questions and Answers
Call Participants
Prepared Remarks:
Operator
Ladies and gentlemen, thank you for standing by. Good afternoon and good morning. Welcome to the Sanofi Q4 and Full Year 2017 Earnings Results Conference Call and Live Webcast. I am Emma, the Chorus Call operator. I would like to remind you that all participants will be in a listen-only mode and the conference is being recorded. After the presentation, there will be Q&A session. You can register for questions at any time by pressing "*1" on your telephone. Should you need assistance, please press "*" followed by "0" to call an operator. The conference must not be recorded for publication or broadcast.
At this time, it's my pleasure to hand over to Mr. George Grofik, Vice President, Head of Investor Relations at Sanofi. Please go ahead, sir.
George Grofik -- Vice President, Head of Investor Relations
Good morning and good afternoon to everyone on the call. Thank you for joining us to review Sanofi's fourth quarter and full-year results. As usual, you can find the slides of this call on the Investors page of our website at www.sanofi.com. Moving to Slide 2, I would like to remind you that information presented in this call contains 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 20F document on file with the SEC and also our document de référence for a description of these risk factors.
With that, please advance to Slide 3 and let me introduce our speakers for today. With me are: Olivier Brandicourt, Chief Executive Officer; Elias Zerhouni, President, Global R&D; and Jérôme Contamine, Executive Vice President and Chief Financial Officer. Also joining us for the Q&A session are: Olivier Charmeil, Executive Vice President, General Medicines & Emerging Markets; Karen Linehan, Executive Vice President, Legal Affairs and General Counsel; David Loew, Executive Vice President, Sanofi Pasteur; Alan Main, Executive Vice President, Consumer Healthcare; Stefan Oelrich, Executive Vice President, Diabetes & Cardiovascular; and Bill Sibold, Executive Vice President, Sanofi Genzyme.
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First, Olivier will discuss the key highlights then Elias will provide an update on our efforts through sustained innovation. Lastly, Jérôme will review Sanofi's financial results before we open the call up to Q&A. As in the previous three quarters, we will refer to sales growth at both constant exchange rates and constant structure in order to facilitate comparisons on a like-to-like basis.
With that, I'd like to turn the call over to Olivier.
Olivier Brandicourt -- Chief Executive Officer
Thank you, George. Good morning and good afternoon to everyone. Welcome to our fourth quarter and full-year earnings conference call. On Slide 5, before I discuss 2017 performance, I want to take a couple of minutes to step back and review our recent achievements as we focus on the strategic transformation of Sanofi. In terms of reshaping the portfolio, we just announced the acquisition of Bioverativ and Ablynx, two important new members which will become part of the Sanofi family soon, subject to the completion of these acquisitions. This will strengthen our leadership in rare diseases, especially in rare blood disorders. I will return to this shortly. We also expect to sign definitive agreements for our EU generics business in the quarter and we recently expanded our vaccines GBU through business development.
When we think about launches, we have been candid that several are progressing more slowly than anticipated. On the other hand, we are delighted with the rollout of our new immunology franchise, especially Dupixent, which has exceeded our expectations. In terms of simplification, we have delivered the €1.5 billion of savings we promised and we have gained global rights to fitusiran, further supporting our aim of leadership in rare blood disorders.
When it comes to innovation, you heard about the transformation of our ING organization with Sustaining Innovation Day in December. Since then we have scaled up our investment in cemiplimab and dupilumab to reflect the commercial opportunities. And looking ahead, the acquisitions of Bioverativ and Ablynx will internalize a promising late-stage rare disease asset and a proven discovery engine in the Nanobody platform. Overall, we are pleased with the steps we have taken to reposition and strengthen the company.
Turning to the Bioverativ and Ablynx deals, I do want to stress that we have maintained our financial discipline in our approach to M&A. In particular, we expect both deals to deliver returns above our cost of capital within three years and we expect Bioverativ to be immediately accretive to earnings. So we remain consistent with guiding criteria you have heard us state over many quarters.
Slide 7. In a series of three strategic actions in less than a month, we believe we are well on our way to building a leading rare blood disorder franchise. As you know, Bioverativ will bring to Sanofi a ready-made, strong franchise in the $10 billion hemophilia market. However, we are looking at this acquisition more broadly as a platform for expansion in rare blood disorders. Ablynx will be an important element of this strategy. In the near term, it will enhance our portfolio through Caplacizumab, which we expect to be approved this year as a first treatment for acquired TTP. When looking further down the line, if we think about adding in fitusiran along with earlier stage assets from Bioverativ, Ablynx, and Sanofi, you can see why we think this is a great opportunity to build a sustainable leadership position in rare blood disorders.
Slide 8. Of course, our interest in Ablynx extends far beyond one rare disease asset. As you heard at our Sustaining Innovation Day, we have transformed our approach to R&D based on a strategic shift toward biologics, multi-targeting, and proprietary platforms. Ablynx ticks all three of these boxes and, in particular, it is already a core element of our multi-targeting strategy through our Nanobody partnership in a range of immuno-inflammatory diseases. Nanobodies are biologics which combine the specificity of antibodies with many of the advantages of small molecules. Being able to access this unique technology platform by bringing it fully in-house will clearly strengthen our discovery and development efforts.
Turning to the financials, on a full-year basis, Sanofi delivered 2017 results which were in line with our guidance in spite of a challenging fourth quarter. At constant exchange rates and constant structure, our sales grew by 0.5% to €35 billion. At CER, our business EPS was broadly stable at €5.54 despite the €0.10 impact of the Dengvaxia charge. As you know, changes in structure had a distorting effect on our sales growth in 2017. If we adjust for this, then our sales growth and CER at a constant structure would have been 0.5%. In other words, we delivered stable sales and even achieved slight growth despite the expected decline in our U.S. diabetes and similar American franchises. This was clearly helped by the roughly half a billion euros in incremental new launch sales.
Turning to the fourth quarter, here you can see the sales picture across our five GBUs. The highlight was the continued double digit growth from Sanofi Genzyme. Our Vaccines business only grew by about 1% for reasons I will discuss later. And as expected, we saw declines in DCV and GEM, reflecting losses of exclusivity.
Turning to Slide 12, we are now looking at sales by franchise and geography in Q4. Our performance in developed markets was similar to the first nine months, with the growth of Sanofi Genzyme and Vaccines being more than offset by the pressures on our Diabetes and established product franchises. For emerging markets, however, fourth quarter of 2% was slower than in previous quarters, mainly as a result of a decline in vaccine sales and this was in part due to the Dengvaxia label update.
For our Specialty Care franchise on Slide 13, sales grew by 16.5% in the quarter and 14.5% for the year. The main drivers were Dupixent, which delivered sales of €118 million in the quarter, and double digit growth in our Multiple Sclerosis franchise. We also saw good progress from Kevzara, our other immunology asset, and a strong quarter in Rare Disease, which ended the year with fourth quarter growth of 8%. Our MS franchise continued to grow despite increased U.S. competition and here the 11% fourth quarter growth was entirely driven by Aubagio whereas Lemtrada was stable.
Before I move on from Specialty Care, I would like to say a few words about the global rollout of Dupixent. You have seen from the fourth quarter sales that Dupixent is performing strongly in the U.S. More than 33,000 patients have now been prescribed this groundbreaking medicine and our goal in '18 is to strengthen our message in the U.S. with prescribers but also with consumers through DTC. Outside the U.S., we launched Dupixent in three European countries, including Germany. In '18, we will launch across the rest of Europe as well as Japan and select emerging markets. So we have a very busy year ahead with Dupixent in Atopic Dermatitis.
Furthermore, we believe we have the best in class profile of any biologic in asthma. We filed the PLA and we are now engaged in pre-launch activities with specialists. We are looking forward to bringing this important new treatment option to market in this first quarter.
Turning to Vaccine, fourth quarter sales grew by 1.2% but were up 8.3% for the year. A number of factors affected the Q4 performance. On the negative side, as we had signaled, the phasing of CDC orders of Menactra and a high base for comparison of Pentacel in the U.S. had an adverse impact. Sales for the pediatric combination family were flat, as strong performances in Europe and China were offset by a timing impact for tenders in the emerging markets. Of course, what we didn't foresee was the label update for Dengvaxia. This resulted in negative revenues for Dengvaxia in the quarter, which in turn lowered our overall vaccine sales growth by 2%. Offsetting this impact, we delivered a strong performance in flu vaccines, with sales up 21%. This was driven by pandemic purchases in the U.S. and by the launch of VaxigripTetra in Europe. With the help from the strong flu performance, our European vaccine business continued its trend of accelerated growth, with sales up 38%.
Now looking to 2018, I want to make you aware that vaccine sales during the first half are expected to be lower than last year. This will be mostly related to a testing issue for Pentacel in China and the phasing of Menactra orders. Please keep in mind, however, that sales in the first half of the year for Vaccines are typically lower than the second half given the seasonality of the flu franchise.
On Slide 16, sales of our Global Diabetes franchise declined 16% in the fourth quarter and 11% for the year. This was in line with our expectations and reflected the high base of comparison in the U.S. that we had signaled for the quarter. U.S. Diabetes sales declined by 30% in the quarter, which compares to 20% in the first nine months. This more than offset good growth in emerging markets, which now account for nearly a quarter of our Global Diabetes sales and a slight increase also in Europe.
Despite the tough backdrop, we continue to make progress with Toujeo, which achieved full-year sales of over €800 million and continued to gain share globally. Now, when we look at the early part of '18, U.S. trends in Diabetes are in line with our expectations and consistent with the payer coverage update we provided in November. In particular, we are seeing the expected impact of the loss of some coverage in Medicare Part D since January 1.
Switching to Praluent, quarterly sales exceeded €50 million. Of course, we are eagerly awaiting the top line results from ODYSSEY OUTCOMES, which we expect soon and will present at a late breaker at ACC with a slot reserved on March 10th.
Turning to our CHC business, sales grew by 2.5% in the fourth quarter and 2.1% in the year. We were pleased to see a pick-up in growth in the fourth quarter in the U.S. and Europe following a couple of quarters that were impacted by seasonal factors. Growth in Europe was especially strong, helped by a strong cough and cold season. On the other hand, after several quarters of improved performance, our CHC business in emerging markets declined slightly. This was impacted by lower sales in Russia, largely from a change in a distribution agreement with a third party.
My final slide, our emerging markets business remained a key driver, with sales up 6% for the year. As I mentioned earlier, our performance in the fourth quarter was somewhat weaker due to Vaccines. However, China remained a strong double digit growth driver.
With that, I'd like to hand over to Elias.
Elias Zerhouni -- President, Global R&D
Thank you, Olivier. It's a real pleasure to be here and to have the opportunity to update you all on our recent developments and how these developments are helping to build our innovation engine.
So first I'd like to start with Ablynx. And if it wasn't very clear on the call a couple weeks back, I want to really tell you how much we value the acquisition of Ablynx and how impressed we are by the Nanobody technology and what this will bring to our discovery and development capabilities, as mentioned by Olivier. For those of you who are less familiar, this is a very unique platform which allows the efficient development of highly specific biologic agents which can be readily customized to get two, three, or more targets inside a single pathway. And unlike traditional antibodies, they share some of the beneficial characteristics of small molecules, which include the ability to hit tough targets, such as IN channels, and they have the potential also to be delivered by different routes, such as inhaled, oral, or topical routes. It's also important to note that this technology is de-risked to a large degree, with over 45 programs under way, eight of which are in clinical trials, and more than 2,000 patients and volunteers exposed to treatment.
So we were already actually attracted by this platform to have worked with Ablynx since 2015 in MS and to have signed a broad Nanobody collaboration in immuno-inflammation in 2017. So it's fair to say that we know the technology quite well and we know what it can bring to Sanofi and, as mentioned by Olivier, it is right in line with the transformed strategy that we have put in place of biologics, proprietary platforms, and multi-targeting capabilities in novel molecules.
I also want to say a few words about Caplacizumab. As you heard from Olivier, we are trying to build a rare disease, rare hematology disorder franchise. And this slide here shows the results of the recent HERCULES Phase 3 study of Caplacizumab in patients with acute thrombotic thrombocytopenic purpura, which is a disease that prevents platelets from being able to do their job and actually aggregates the platelets to the point where you have microthrombocytes throughout the body with a 20% mortality rate. And it tells you why we think this is such a promising asset. As you can see, blood platelets in this sick group of patients rapidly returned to normal, with Caplacizumab in the active group scoring much better than placebo across the range of relevant secondary endpoints, including recurrence rates, days in the ICU and the hospital, and especially requirements for plasma exchange, which is the only effective form of therapy today.
We think the data is very compelling, especially set against the high unmet need in this potentially life-threatening rare clotting disorder. As a consequence, we are confident Caplacizumab will be the first drug to be approved for aTTP, potentially in Europe in 2018 and in the U.S. next year. As Olivier said, this drug should fit in very nicely along Bioverativ's hemophilia franchise.
Speaking of Bioverativ, Olivier already explained how this provides the platform to expand in rare blood disorders. But from the R&D perspective, we believe it has a number of very attractive assets in development as well. In its current field of expertise, Bioverativ is utilizing a promising peptide linker technology known as XTEN to build on its success with Eloctate and Aprolyx and further lengthen the time of the Eloctate product's molecules and therefore reduce the dose frequency, which is a very valuable aspect of therapy in hemophilia. The need here is greatest in Hemophilia A, where extended half-life factors are currently given twice weekly, and the aim is to get to once weekly dosing or less.
Another particularly interesting asset is Bioverativ's 009, which is in Phase 3, for Cold Agglutinin Disease and Autoimmune Anemia. And by modulating the complement cascade, this may be the first treatment for this potentially serious disorder, which is reflected in its FDA breakthrough therapy designation. At earlier stages, Bioverativ has access to novel gene-editing technology through its alliance with Sangamo and this opens the ability and puts it at the forefront of cell therapy for two important genetic disorders: Sickle Cell Anemia and Beta-Thalassemia. Both are characterized by abnormalities in red blood cell production and this technology could help restore normal function to these patients.
Switching gears now to our programs with Regeneron in Oncology and Immunology, we recently announced a major scale-up in the combined investment efforts behind our PD1 Cemiplimab and this followed the positive results of the pivotal study in cutaneous squamous cell carcinoma and based on our assessment of the opportunity across a range of tumor types, including non-small cell lung cancer. And in addition, we and Regeneron announced an acceleration of our program with Dupilumab, Dupixent in COPD and certain allergic disorders, together with an expansion of the program for our complementary IL33 antibody. Each of these investment decisions was based on the strength of the clinical data we are seeing with these assets.
On my final slide, I want to signal some important upcoming milestones in what will be a very busy year for our R&D organization. We are planning over 15 new, pivotal Phase 3 studies this year. And so you can expect to see a number of important milestones and regulatory submissions, including for our oncology assets, Cemiplimab, and our C38 Isatuximab, as well as Sotagliflozin in Type 1 Diabetes, the U.S. trialing of Caplacizumab. In addition, we plan to submit important label extensions for Dupilumab and Praluent and the latter obviously will be based on the ODYSSEY OUTCOMES as mentioned by Olivier.
So with that, I'd like to hand it over to Jérôme.
Jérôme Contamine -- Executive Vice President and Chief Financial Officer
So thank you, Elias, and good morning and good afternoon, everyone. I'm going now to Slide 26. And before discussing the details of the PNL, I would like to highlight and comment on the impact of FX on our reported fourth quarter figures. So in total, currency movements reduced reported sales by 6.1%, or €539 million, on reported business EPS by 6.4%, or €0.08 per share. This clearly resulted also in an overall adverse effect impact on both sales and business EPS for the full year of approximately 2%.
Now I move to Slide 27, looking at the P&L on a reported basis. Sales in the fourth quarter were €6.7 billion, representing 4.1% CER growth. As in the previous quarters, we faced a headwind from the loss of animal health contributions. In addition, the Dengvaxia label update impacted our business operating income by €158 million in the fourth quarter. Against this, we benefited from the substantial reduction in the Q4 effective tax rate, which adjusts to a full-year rate of 23.5%. These impacts resulted in business net income declining 10.8% at CER in the quarter to €1.3 billion, with business EPS down 8.8% to €1.06, helped by share repurchases. If we add back the €0.10 Dengvaxia charge, business EPS would have been broadly stable.
On the subject of tax, when we look to 2018, the impact of tax legislation changes, especially in the U.S., will allow us to lower our expected effective tax rate for the year, I mean the year 2018, to around 22%.
Now I move to Slide 28. Here you see our P&L at CER constant cost structure in the fourth quarter. Our gross profit declined at a faster rate than sales, as a benefit of efficiency savings and Specialty care growth, was more than offset by charges officiated with Dengvaxia, accelerated declines in U.S. diabetes and [inaudible]. At the BY level, there were some offset of the [inaudible] contribution in our [inaudible] lines, which is now becoming a meaningful driver. Overall, this continued investment [inaudible] launches and priority on the programs, we were unable to achieve the operating leverage we saw in the first nine months.
Looking forward, to help you in your modeling for 2018, on the full-year basis at CER, a constant exchange rate, we expect the gross margin to be between 70% and 71% as compared to 70.6% in 2017. Regarding R&D and SG&A, we expect the total, i.e. the total of our expenses, to grow between 3% and 4%. This includes the acquisitions of Bioverativ and Ablynx and their impact in 2018. And, of course, it would not influence 2017's figure. Also this increase is mostly driven by R&D expenses increase, which is definitely in line with what Elias has presented before as well as Olivier, in connection with our internal program plus the contribution of the two acquisitions.
On Slide 13, I would like to note that in a changing year, Sanofi met all of its 2017 financial performance objectives. Despite the changes we faced, we delivered our business EPS guidance for the year and we met the high end of our initial guidance.
And note on the next slide, our Board is proposing an annual dividend of €8.03, which represents a 2% increase and the 24th consecutive year that Sanofi has increased its dividend. Our progressive dividend policy remains an important part of our value proposition to shareholders. And based on the average share price last month, the proposed dividend implies a 4.2% dividend yield. In the past year, including buybacks, we've given €5.5 billion to shareholders while still maintaining a strong balance sheet. I should also point out that following the recent acquisition announcements, our credit ratings of AA by Standard & Poor's and A1 by Moody's have both been reaffirmed.
On my final two slides, I want to set the scene for the coming year. When we think about our sales performance in 2018, a number of headwinds are likely to impact the first half despite the expected strong performance on Dupixent. As already mentioned, vaccine sales are likely to decline for the first half as a result of phasing and inactive sales, in particular in China. In addition, in the U.S. we are facing the realization of Sevelamer, which we didn't have in the first half of last year. In Diabetes, as we noted in the fourth quarter, we managed some expected covered in our Part D business and a continued decline in average net prices, which will persist throughout the year. As you know, last quarter we refined our 2015 to 2018 Diabetes sale outlook to -6% to -8%. We are in the final year of this period. For your modeling consideration, the midpoint of this outlook would imply a decline in 2018 of around 9% at CER.
By the second half, however, we expect some of these factors to annualize and to be more than offset by positive drivers. Clearly, in addition to Dupixent, the consideration of Bioverativ and the impact of new launches, such as Flublok, Kevzara, and Admelog will be important. We also await the results of the ODYSSEY OUTCOMES study, which would provide an upside opportunity for Praluent. All this means we expect the second half balance to our growth during 2018.
Now turning to the outlook for the year as a whole. In 2018, we expect to grow business EPS by between 2% and 5% at constant exchange rate. For the reasons we just outlined, you should assume that this growth will be weighted to the second half. In terms of FX, based on December 2017 exchange rates, the impact on business EPS is expected to be -3% to -4%. However, given the volatility we are seeing in the currency markets in January, the FX impact could be closer to -8% in the first quarter at current exchange rates. This impact will, of course, fade away in the following quarters.
I would now like to turn the call back to Olivier.
Olivier Brandicourt -- Chief Executive Officer
Thank you. So to summarize, against a challenging backdrop, we worked hard in 2017 to create value by executing on our strategic transformation. We delivered on all of our financial objectives despite expected and unexpected challenges. We successfully launched a new immunology franchise led by Dupixent. We made good progress with our pipeline and with advancing our research capabilities as you heard on our R&D day. And finally, through our recently announced acquisitions, we will have a strong position in rare blood disorders, which we expect to create long-term value for our shareholders. So with that, I'd like to hand it over to George to start the Q&A.
George Grofik -- Vice President, Head of Investor Relations
Thank you, Olivier. We will now open the call to your questions. And as a reminder, we'd like to ask you to limit your questions to two each.
Questions and Answers:
Operator
Ladies and gentlemen, we will now begin the question-and-answer session. Anyone who wishes to ask a question may press "*" and "1" on their touchtone telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press "*" and "2." Participants are requested to only use headsets while asking a question. Anyone who has a question may press "*" and "1" at this time.
The first question comes from the line of Mr. Meunier with Morgan Stanley. Please go ahead.
Vincent Meunier -- Morgan Stanley -- Analyst
Good afternoon. Thank you for taking my question. The first question is on the capital allocation in the context of the recent deals. Do you have any interest in making more biotech acquisitions or do you prefer now other options like acquiring assets in other areas, like Consumer, or focusing on the integration of these two assets? And can you also make a few comments on the integration of the research units in Belgium and the U.S.? And I have also a question on the 2018 guidance. Is it possible for you to give the guidance excluding the Bioverativ and Ablynx deals? Thank you.
Olivier Brandicourt -- Chief Executive Officer
Alright, thank you very much, Vincent. So capital allocation, you may remember that we had given ourselves a global [inaudible] for inorganic growth of €20 billion, right? And that was for all [inaudible] and we achieved with these two acquisitions about €13 billion, which tells you that we have still eventually some funding to eventually get new opportunities. I would not make any specific comment on CHC. As you know, CHC is one of our GBUs. We have already done a deal with our swap in 2016 and it remains, again, a very important business for us and we continue to look at potential opportunities but I won't go beyond that.
We have consistently communicated that our priority in terms of allocation and use of our free cash flow will be organic investments, acquisition as we just described, dividends, and stock repurchase. And, again, as we have demonstrated over the last several years, we have, and Jérôme mentioned it, share buybacks has been a very important overall capital allocation strategy, since we have repurchased about €5 billion in the last two years. So that's about capital allocation.
Your next question, maybe Elias, you want to talk about integration of R&D from Ablynx?
Elias Zerhouni -- President, Global R&D
Sure. Well, as you know, Vincent, we've developed quite a bit of good expertise in integration, as you've seen with Genzyme. At the current time, obviously we're focused on closing the transaction so I can't comment on the specifics of the integration as we're going through it. However, you should not that we have over 900 employees in Belgium. We have facilities there and manufacturing. So we are really hoping to preserve, actually the effectiveness of these organizations. Bioverativ is located in Boston. So we do obviously want to preserve the effectiveness of these organizations as we have in the past. But integration topics will be taken up later in the year.
Olivier Brandicourt -- Chief Executive Officer
Okay. And on your question on the guidance, I'm going to ask Jérôme to answer.
Jérôme Contamine -- Executive Vice President and Chief Financial Officer
Thank you, Olivier. And thank you, Vincent, for your question. So actually as you understood, I mean, we already gave you your information, I think. The first is that Bioverativ, we assume it will be accretive as early as 2018. The magnitude of its accretion will depend upon the exact timing of the closing of the transaction as well as our pace of integration. And of course, the details and what we decide to do or not do when it comes to Bioverativ and R&D, Elias described that, so we may see advice on what the R&D plan is here. On Ablynx as well. I mean, this will clearly depend on the integration and closing timing, which as you know is planned for Q2.
I also gave you a few guidelines here in this call, which is on the cost margin, where we expect the cost margin to stay between 70% and 71% at constant exchange rate and this compares to the 70.6% for '17. Obviously this includes these acquisitions. Obviously, as well, you could say that Ablynx, as such, will not be a contributor in the cost margin for all these reasons, or very marginally full-year, when [inaudible] has just been launched. But I would say it should not impact very much our figures in '18.
And the last thing I tried to really give guidance on is on the other operating expenses line. I think I said that we said that our overall R&D plus SG&A line should, altogether with inclusion of these acquisitions, should be between 3% and 4%. And it's difficult to be more precise here. And this includes contributions of the acquisitions. Of course, I mean, as you understood, the bulk of this increase will be weighted toward R&D, both in connection with the program that Elias has described, including our accelerated investment with our partner Regeneron on the Caplacizumab, as well as lifecycle management on the Dupixent/Dupilumab and on the IL33. And so that's maybe what you should -- I mean, of course, you need to also -- expenses from Ablynx, for example, which clearly will be mainly on the expenses.
Last, it's difficult to go into more detail because, as a matter of fact, you take my tax rate or I take interest rate charges and then at the end of the day it's a combination. This combination results in the guidance that we have given to you.
George Grofik -- Vice President, Head of Investor Relations
Okay, Vincent, thank you very much. Next question.
Operator
Your next question comes from the line of Peter Verdult with Citi. Please go ahead.
Peter Verdult -- Citigroup Global Markets -- Analyst
Good morning. It's Pete Verdult here from Citi. Two questions for Olivier or Bill. Firstly, on the MS franchise, on Aubagio, can you give any more details as to the settlement with the generic companies? Should we assume that we should see Aubagio generics somewhere midway between the 30-month stay in '20 and the first patent expiring in '26? And then on Lemtrada, do you think that franchise can grow going forward and is the impact purely accretive or are you also seeing an impact from Mavenclad in Europe? And I realize that's two questions so I'll leave it there.
Olivier Brandicourt -- Chief Executive Officer
Alright, thank you very much, Peter. It happens that Karen Linehan, our General Counsel, is with us so she will answer the first question on Aubagio and, Bill, you will answer the Lemtrada question. So, Karen, please.
Karen Linehan -- Executive Vice President, Legal Affairs and General Counsel
Hey, good morning and afternoon. Thank you for the question. Please recall that we sued all ante-filers and we triggered that 30-month stay, which meant that no generic could enter the market before March of 2020. In the U.S., we have settled all of those cases. They have been dismissed and the settlement was favorable relative to the end of the 30-month stay. The matter will be updated in our upcoming 20-F.
Olivier Brandicourt -- Chief Executive Officer
Okay, so a few weeks to have the final answer here. Lemtrada?
Bill Sibold -- Executive Vice President, Sanofi Genzyme
Thanks, Peter, it's Bill here. So just a couple of context points here. So the high-efficacy segment is now the fastest growing segment in Multiple Sclerosis. We saw that the global shares now above 12.3% and in the U.S. it's up to 18.7%. So really very strong growth there. And when you think about the revenue growth for Lemtrada, it's impacted by its unique and durable effect of dosing. And the patient base must be essentially replaced every two years. So think about it. You have five infusions in the first year on consecutive days, you wait a year, you have three infusions, and then you likely don't have any infusions after that. So we're talking about 53 weeks where a patient is actually generating revenue, if you will, and they benefit from that long-term effect. So global sales growth was 13.6%. In Europe, 18.5%. In the U.S., 7.3% on the year. And you see in Q4 in the U.S., sales were down 10%. And that has a lot to do with that unique dosing regimen that I mentioned.
Also we're coming off a very strong Q4 2016, which was buoyed by a strong Q4 2015. And so if you recall in 2015, October 2015, we got a permanent Q code in the U.S. We had a lot of first infusions in Q4 2015. And Q4 2016, those second courses, those three additional second course infusions took place. So in 2017, those patients are no longer receiving Lemtrada.
Olivier Brandicourt -- Chief Executive Officer
Because you have very good clinical results over a period of how many? Seven years.
Bill Sibold -- Executive Vice President, Sanofi Genzyme
Exactly. And as we reported out at Ectrom last year, the seven-year data, where you have around 50% of patients, after six years since their last infusion, not receiving anything. So truly there's a huge benefit to patients and to the system from a cost perspective over time and that's why Lemtrada has been considered such a cost-effective medication.
Olivier Brandicourt -- Chief Executive Officer
Since we are on MS, why don't you talk about Aubagio performance, Bill?
Bill Sibold -- Executive Vice President, Sanofi Genzyme
Yeah. So Aubagio was very strong in 2017. Patients grew by over 22% and sales grew 23%. And just some context there. Aubagio is ahead on patient market share, ahead of Tecfidera in 31 countries around the world. In Q4, sales were up almost 14% globally and they were up about 10% in the U.S. And just context in the U.S., TRXs were up about 2% quarter-to-quarter, so from Q3 to Q4, and we had a negative impact of around 4% due to an inventory decrease. So adjusted, the U.S. growth would have been around 14% in the U.S.
Olivier Brandicourt -- Chief Executive Officer
Right. And globally Aubagio is up what? 23%?
Bill Sibold -- Executive Vice President, Sanofi Genzyme
23%. Yeah.
Olivier Brandicourt -- Chief Executive Officer
Okay. Alright. Thank you very much. Next please.
Operator
The next question comes from the line of Florent Cespedes with Société Générale. Please go ahead.
Florent Cespedes -- Société Générale -- Analyst
Good afternoon, gentlemen, thank you very much for taking my questions. Two products related questions please. First of all, for Bill on Dupixent, could you share with us the feedback you have from the pre-launch activities on asthma as this market is more crowded than atopic dermatitis. And my second question for Stefan or Elias on Praluent, will you provide an update on the positioning and the potential of this drug when you will have data publicly available? And my follow-up question is do you have the data internally already and, if that is it the case, do you intend to send a press release or do we have to be patient and wait for the ACC late breaking session presentation? Thank you.
Olivier Brandicourt -- Chief Executive Officer
So thank you very much, Florent. I think I can answer the last one. Unfortunately, I think you will have to be patient. And we have a late breaker which is already booked on March 10th and that's where we're gearing toward. So that's the answer to the last one. Then I go to Bill, Dupixent, do you have any insights, Bill, on asthma pre-launch?
Bill Sibold -- Executive Vice President, Sanofi Genzyme
Yeah. So we've been working diligently on the pre-launch for asthma. You know, you mentioned that it is a competitive market. We believe that we have a very differentiated product. We have a consistent effect that we've seen on both exacerbations and lung function. The feedback that we've been getting so far from physicians in feedback sessions that we've had is very favorable toward Dupixent. They believe that it does have a differentiated profile. So through the rest of 2018 or as we get into 2018, expecting to launch in the fourth quarter in the U.S., we'll continue to build our infrastructure, our teams will be in place, and we'll be ready to go once we have approval. We're optimistic about the profile, as I said. It is the only product of its class, Aisle 4, Aisle 13, with really demonstrated strong effects on two key measures of efficacy.
Olivier Brandicourt -- Chief Executive Officer
Remarks
Stefan Oelrich -- Executive Vice President, Diabetes & Cardiovascular
Thank you very much, Bill. Florent, as you heard us at the initiation of this call, we still have very much a commitment behind Praluent so I'm going to ask Stefan to talk about patient population and positioning and potentially utilization criteria with payers. If you can draw the picture for Florent, please?
Olivier Brandicourt -- Chief Executive Officer
Yes, thank you, Olivier. Hi, Florent. Stefan here. So first thing, by the way, we don't have the data. So we will not have the data in hand until very shortly before the late breaker. So not only you will have to wait, we're waiting as well for the data. The second thing, on the positioning and the potential. So on positioning, we've been already anticipating obviously our patient population aligned with the ODYSSEY population. So we're going after high-risk patients and after FAH patients for the patient population. We target and we also anticipate that guidelines, if our trial reads positive as we believe, will fall at that direction because this would be then the second time that a PCSK9 number would have proven an outcome benefit, which would be class-defining later on for a guideline.
In terms of our potential, we believe that following the trials it will further help to improve utilization management criteria that may be further lifted. We've seen some progress with this following also the Repatha readout from their trial all over 2017 of about 10% improvement in terms of utilization management criteria, lowering the rejection rates from about 50% to 40%. So we would anticipate that as our trial reads out positive as we hope, that that will continue. And then in a second step, if we really redefine that class as we expect, we would anticipate end of 2018, beginning of 2019, a change of the guidelines and that change will open a new opportunity to further maximize the potential of this opportunity.
Olivier Brandicourt -- Chief Executive Officer
Thank you very much. Elias, do you want to add anything?
Elias Zerhouni -- President, Global R&D
No, I just wanted to be clear that we do not have the data in-house. That was Florent's question and Stefan addressed it.
Olivier Brandicourt -- Chief Executive Officer
Okay. Alright. Perfect.
Florent Cespedes -- Société Générale -- Analyst
Thank you very much.
Olivier Brandicourt -- Chief Executive Officer
Thank you. Next please. Next question.
Operator
The next question comes from the line of Graham Parry with Bank of America Merrill Lynch. Please go ahead.
Graham Parry -- Bank of America Merrill Lynch -- Analyst
Thanks for taking my question. So firstly, I was hoping you can give us some more line insights on R&D going forward. And you'd previously guided to your €6 billion of spending by 2020 but that was originally given back in 2015 when you still owned Merial. You hadn't bid for Bioverativ or Ablynx and the euro dollar was 1.10, probably 1.20 to 1.24 now. So could you give us an update on that guidance number? Would it include Bioverativ? Should we be adjusting it for currency? And secondly, your guidance for the year is negative for 2018. It's negative 3% to 4% FX headwinds at December rates. Now clearly euro dollar is different to December rates and you've given us a feel for what Q1 would look like at spots, but could you help us understand what you think your FX headwind would be for the remainder of the year at these spot FX rates rather than December?
And then finally, on your guidance, you look to be in line with current consensus but you've got a 3% boost from lower tax and, on our estimates, about a 3% boost from the acquisitions that weren't in consensus. So that implies you're operationally about 6% below consensus. So can you what operating profit margin growth and margin progression is assumed in your guidance? Thank you.
Olivier Brandicourt -- Chief Executive Officer
Alright. Thank you very much, Graham. Jérôme, question two and three? Operationally?
Jérôme Contamine -- Executive Vice President and Chief Financial Officer
Yeah, so on the effects. So hopefully I got your question. So first of all, as you know, we always guide on existing exchange rates because it's hard to guide on non-existent, honestly. It is why we have decided to guide on the December exchange rates. And we have been systematic in doing that. This is why we have guided on the -3% to -4% based on the average exchange rate for December. Now, because clearly there's been all this activity ongoing, as you know, and the U.S. dollar in particular being weaker, the euro being stronger and a few other changes here, we also guided you for the first quarter.
For the first quarter, it is fair to say that, if we assume that these exchange rates that we have now, let's say up from the beginning of the year to mid-February, then we could expect that it, for the first quarter, would be around -8% versus last year. Of course, if you look forward, if you look at the low exchange rate, for instance, for the dollar versus the euro, which you have in the first quarter of '17, on a relative basis the impact will be much lower when you go into the coming quarters. So I hope it clarifies and maybe, if not, you can just get your question back.
On the last question, I think that we really tried to be, again, as precise as possible. I mean, you mentioned R&D and Elias will comment on that. And we make it clear that we think that, with what said on the Innovation Day, and we mentioned the €6 billion, and on top of that comes the Bioverativ as well as the Ablynx program, it's clear that we are heading to the €6 billion plus quicker than cap. Okay. So I think that's where we are. and we also, to help you even more, we have tried to model the increase of the overall operating expenses line, which, if you recall, it was from €15 billion in 2017, seeing this operating expenses line should grow by 3% to 4% altogether and mostly, mostly coming from R&D. So I think with that, I think it gives you a view on where the R&D line is heading.
On the tax rate, well, you know, today we are at 23.5%. This was the outcome of the full-year 2017. So as you know, in many tax areas, there's a lot of moving pieces across the world. Of course, the most important is the U.S. But I would not minimize the current tax rate in France either. So altogether from this 23.5%, I mean, we just guided to 22% for 2018, meaning that we gained something like 1.5%. Now, also you could say, when you look at the P&L, because we are doing this acquisition, in terms of the charges, the costs of that will be limited. It would not be exactly the same level as where we are in 2017. So, I mean, it's hard to be more precise. And as you know, on top of that, the consensus is maybe not really taking into account all the FX changes, which just happened recently. So it's hard for me to get closer or more precise versus what I have, which is at the actual exchange rate on the guidance I'm giving to you today to compare with the consensus, which was based from a previous situation, a previous tax rate, a previous exchange rate, no increase in acquisitions either. So hopefully it helps you to understand where we are.
Graham Parry -- Bank of America Merrill Lynch -- Analyst
Can I just come back on the R&D line? So you're saying €6 billion plus the Bioverativ and Ablynx, but should we make an adjustment down on the €6 billion given what's happened with FX? Or are you saying in absolute terms, in today's FX, you still think in 2020 it'd be north of €6 billion on the R&D because of the acquisitions?
Jérôme Contamine -- Executive Vice President and Chief Financial Officer
Okay. You speak about 2020? Olivier, do you want to?
Olivier Brandicourt -- Chief Executive Officer
Yeah, I think the target of €6 billion comes maybe slightly earlier than 2020, maybe including the FX impact, because of what we are getting from Ablynx and Bioverativ and also the investment in immuno and oncology. So referring back to today, we spent here on innovation, you have seen the richness of the pipeline we have to prosecute now. You heard Elias earlier talking about [inaudible] [00:57:00]. And so all of that leads us to €6 billion maybe earlier than 2020.
Jérôme Contamine -- Executive Vice President and Chief Financial Officer
And maybe to make a link between your two points. It's fair to say that with a lower exchange rate for the U.S. dollar versus the euro, it will benefit, in absolute terms in Euro, to our R&D line. So it's where it starts to be a little bit difficult to be exact but you could say that if you take a low -- so the exchange rate for the U.S. dollar versus the euro, it may offset what Olivier is describing long-term the investment behind all our R&D.
Olivier Brandicourt -- Chief Executive Officer
So FX can help us on the long-term.
Jérôme Contamine -- Executive Vice President and Chief Financial Officer
Yeah, it comes with a limit of how you can model it. But it's true that altogether this would be --
Olivier Brandicourt -- Chief Executive Officer
No, it's a good point. The FX plays a role. Yeah. Elias, do you want to add anything?
Elias Zerhouni -- President, Global R&D
No, no. I think it's important. The upside of a high euro for me is R&D because we do a lot of R&D outside of Europe. It makes it cheaper for us to do. So we can maintain that line of €6 billion.
Olivier Brandicourt -- Chief Executive Officer
That's Jérôme's point but it's difficult to give him an exact date at which we're going to hit the €6 billion.
Elias Zerhouni -- President, Global R&D
R&D always has these moments of success or not and it's very hard to predict. But my sense is that the high euro has always helped us in maintaining our expenses.
Olivier Brandicourt -- Chief Executive Officer
Alright, Graham, thank you very much. Next please.
Operator
Next question comes from the line of Philippe Lanone with Natixis. Please go ahead.
Philippe Lanone -- Natixis -- Analyst
Good afternoon. Thank you for taking my questions. One, on Lantus, you had mentioned the more difficult H1 but what do you factor in your assumptions about the market share evolution with Tresiba from Novo, which will have an advantage of hypoglycemia from the end of this quarter, possibly as an indication. So it might be also a more difficult H2 on this basis. Second one on Kevzara, we seem to have some slight hope of accelerated takeoff from the Q4 figure at low levels. So any comment on that? Thank you.
Olivier Brandicourt -- Chief Executive Officer
Bill, can you start with Kevzara?
Bill Sibold -- Executive Vice President, Sanofi Genzyme
Absolutely. So, look, I think the way to think about Kevzara as well is, in 2017, patients were essentially only getting the product through medical exception. So there wasn't a clear path to reimbursement. I'll get back to that in a second. We like some of the trends that there are in the U.S. market regarding IL6sub2. So in 2017, IL6 subcutaneous class grew at 20% year-over-year with PRX. And that's outpacing the biologic market, which grew at about 5%. So we think that that bodes very well.
Now, getting back to the reimbursement. We are expecting that, through our efforts in 2017, that we expect about 90 million lines to be covered in 2018, having made progress with CVS-Aetna, Tricare, and a bunch of regional plans. So we believe that as you look to this year, where there is a defined way for people to access the product, that that's when we will expect to see the growth coming because the other market dynamics are strong.
Olivier Brandicourt -- Chief Executive Officer
Alright. Thank you very much, Bill. Stefan? Lantus market share and Tresiba with the potential improvement in their label.
Stefan Oelrich -- Executive Vice President, Diabetes & Cardiovascular
So what we're seeing is that Tresiba has worked on separating second-generation basal insulins, in terms of data that they have, they have been able to put together from first-generation basal. And we're pretty much on a very similar strategy with Toujeo. And for that, we actually look eye-to-eye when it comes to Tresiba. And you can see that it's also a well-glided out performance between Toujeo and Tresiba.
Now, we have recently done some really interesting work on both real world evidence that we're about to present in the coming weeks at a conference and then, more importantly even, we have done a head-to-head trial, the BRIGHT study, against Tresiba, where we were informed about the top line results recently, which is going to be shown at the ADA meeting this year and that we're awaiting publication on as well. I can tell you that, on the top line, we achieved the primary endpoint against Tresiba, which shows comparable effective in terms of A1C reduction. But what we've also investigated in that trial is the safety profile of the product. We're looking forward to the final presentation at the ADA meeting and we feel quite confident that we, as well, with the data that we are more and more bringing together on Toujeo, we can very successfully separate from those first-generation basals.
So I feel actually quite positive about our share evolution. You see this well aligned in terms of how Toujeo is progressing. We see on Toujeo a very strong growth in Europe, with more than 50% growth. Very strong growth in the JPAC region and in the emerging markets, with even more than 50% growth. And in the U.S., we've seen, last year, despite some formulary headwinds that were linked to margin overall, we've seen good volume growth on Toujeo. Fourth quarter, 50% TRX growth on Toujeo is a clear sign that we're going in the right direction here.
Philippe Lanone -- Natixis -- Analyst
Any comments, Stefan, on market share in general in the U.S. more specifically?
Stefan Oelrich -- Executive Vice President, Diabetes & Cardiovascular
I think we're in line with what was expected here and I don't see that change so we're fully in line with the guidance that was given, both financially as well as in prescriptions. So the observed impact on prescriptions in January that we're seeing is fully in line with what was expected. And, again, as we see the label potentially come through for Tresiba, we don't know that yet. So we'll have to see if that's happens. If it does, again, we feel confident that we have all the clinical data to counter that also with Toujeo on our side.
Olivier Brandicourt -- Chief Executive Officer
Thank you very much, Stefan. Thank you, Phillipe. Next please.
Operator
Next question comes from the line of Jo Walton with Credit Suisse. Please go ahead.
Jo Walton -- Credit Suisse Securities -- Analyst
Thank you. Two questions please. On Dupixent, are you seeing any impact of the new plans in the U.S. which appear to be looking to make patients pay their deductible and disallow the copay cards for specialty drugs from the manufacturers. So, if so, how are you looking to counteract that? And secondly, on the overall cost savings that you've been making, Jérôme, I wonder if you could update us as to what level of cost savings for your program you managed to achieve in 2017, what proportion was reinvested, and what we have left to come through in 2018? And perhaps with that also, cost savings that you expect to come through from the Consumer business. Presumably not all of the cost savings from that BI transaction were gained last year.
Olivier Brandicourt -- Chief Executive Officer
Alright. Thank you very much, Jo. Dupixent, the new, emerging plan and copays. I probably think it's too early to understand exactly what's the impact because that just emerged, right? But, Bill, what have you seen?
Bill Sibold -- Executive Vice President, Sanofi Genzyme
No, that's right. In 2017, there was not any measurable impact. In fact, we only heard about it in literally a handful of patients. In 2018 though, we know that the major PBMs who own specialty pharmacies are selling this program to their customers. And as Olivier said, it's hard to quantify at the moment the impact because we won't know the patients involved until we see the copay assistance spend during the year and how that's progressing. So we're working hard to understand it. This is bad for patients. It's limiting access to patients. And we're taking efforts to, as I said, understand, educate on it, and work with these PBMs to explain the negative impact that it's having. So we'll, as the year rolls on, have a little bit greater insight into that.
Olivier Brandicourt -- Chief Executive Officer
Yeah, I think frankly it's more than a Dupixent issue.
Bill Sibold -- Executive Vice President, Sanofi Genzyme
Yeah, it's all specialty.
Olivier Brandicourt -- Chief Executive Officer
It's a specialty medicine, U.S. issue, which has to be discussed and negotiated with many manufacturers. So, Jo, on your question of cost savings, and Jérôme will add, we achieved, in fact, approximately our €1.5 billion cost savings plan we had announced in '15. And we achieved that in '17. So we are basically one year ahead of the plan. But we're not stopping there. We're working on further streamlining initiatives and we recently announced the appointment of Dominique Carouge as Head of Business Transformation. He's going to become a member of the Executive Committee in February or mid-February. And his role will be in charge of accelerating the transformation of the company and therefore we hope, after he's fully on board, to give you an update of what we are planning to do in that space in the next two or three years later this year. Right?
In terms of G&A, of course we expect modest G&A synergies from the recent acquisitions. But we will gain more visibility, of course, in the coming months. And in terms of reinvestment, we have consistently maintained any decision will be scaled to, of course, to the needs of the business and the market environment. And as you may have heard about the adjustment we have made to our sales force on DCV in the U.S. recently. And then again the allocation, and we discussed R&D, which is a big piece of our allocation. So anyway, anything you want to add, Jérôme, on cost savings?
Jérôme Contamine -- Executive Vice President and Chief Financial Officer
Yeah. So, one, as planned, this €1.5 billion of cost savings were the most of it. So [inaudible] in '18 as well. On the question of investments, reinvestments, I think Olivier gave the answer. Obviously you've got all what we have said, that we are investing in R&D significantly on a meaningful path. And, of course, we'll invest behind the new launches, Dupixent and Kevzara in particular. Now if you just remember what I guided for again for '18 on R&D, yes, we'll have cost margin in '18. I mean, clearly, to get there, and with most of the increase coming from R&D, from acquisitions, or from internal R&D, tells us that we are very stringent in how we both save money but also reinvest.
To your question on CHC, I think that maybe, Alan, you want to comment where we are and how much we think we can do even more?
Alan Main -- Executive Vice President, Consumer Healthcare
Thanks, Jérôme. Hi, Jo. This is Alan Main. We don't give specific numbers on cost synergies, but as you know from the BI transaction, the majority of the synergies came from cost synergies rather than top line. And we are right on track. We delivered against 2017 objectives. We're on track to deliver completely on 2018 and beyond. And what we've guided is that we will raise this total business of a BOI of 30% and above. We're, again, right on track to deliver that.
Olivier Brandicourt -- Chief Executive Officer
Okay. Thank you very much, Jo. Next please.
Operator
Next question comes from the line of Seamus Fernandez with Leerink. Please go ahead.
Seamus Fernandez -- Leerink Partners -- Analyst
Thanks for the question. So a couple here that I just want to get a little bit of a better sense of. When we think about the opportunity for Praluent and the PCSK9 market going forward, maybe we can get combined commentary from Olivier just because of your expertise around the opportunity for Lipitor historically and how you're seeing this market evolve at this point. And then, Elias, can you just give us a general sense with Praluent of the kind of data you think is necessary to drive this market forward? Or do you simply think that this is more a matter of getting the price right?
And then my second question is on Dupilumab or Dupixent. When do you really see the earnings inflection that this product and the opportunity for the product is likely to really emerge? As we think about it, we think about it more as kind of a second half '18, early '19 opportunity given how other products have launched in psoriasis. I'm just trying to get a better sense of how you guys are seeing the evolution of uptake of Dupixent and where perhaps you would hope to see more of an earnings inflection from that product and leverage there? Thank you.
Olivier Brandicourt -- Chief Executive Officer
Thank you, Seamus. Elias, do you want to start on the second question?
Elias Zerhouni -- President, Global R&D
Sure. Thank you, Seamus, it's a very good question. So when you really look at the data that's needed to advance, first and foremost is outcomes data on the MACE criteria up front and the net reduction in significant MACE events, in particular stroke and MI, confirmed. So that's the first measure that people are going to look at. Are we reducing that to a significant extent in the population that we are dealing with? And there are two populations really in our selection. First is the FH population, the lifelong risk that cannot be mitigated really with statins. And I'll let Olivier comment about the curve of adoption that it leads to. Because those clearly, as they are identified, have no other option than a PCSK9, no matter what we do in terms of outcome. It's the exposure over a lifetime that drives the outcomes in this patient.
Now, in the other patients, the patients who have an acute event within one year, which is our population, then the rates obviously are higher, the rates of complications. So controlling that rate after a first event in the secondary prevention is going to be driven by MACE. Ultimately, however, the thing that you want to prove, to show in the data, is either a trend or a statistically significant reduction in cardiovascular mortality related to coronary disease de-mortality. Now, this usually, as with Lipitor, took a while to establish because the follow-up is needed to show the event rates that you have. So we'll see with our data where the trends are. If we haven't reached significance, where is it that we are likely to see that happen? Just like in Fovea, I think with time you'll see that separation of the curve, I'm pretty sure. So maybe I'll let Olivier --
Olivier Brandicourt -- Chief Executive Officer
Yeah, I don't have much more to add. We continue to be, and I continue to be, absolutely convinced that those technologies and products will change medical practice, in cardiovascular medical practice. We have not seen that yet. We were liking two convincing studies probably in order to be able, which is pretty standard in our industry, to be able to make the claim. With the ODYSSEY OUTCOMES, we will have a very well-defined population. Right? No question, statins are doing a terrific job. But for those who are not controlled by statins, these technologies are absolutely critical and will save lives.
So it's a step afterwards, and it's exactly what happened with Lipitor at the time, is we're going to see them being a part of guidelines. And I think cardiologists and physicians in general are now very much moved, in their prescriptions or influence in their prescriptions guidelines, and that's what will happen, I guess, here. And that will ultimately bring us to the third step, which is a change by the payer of the utilization management criteria that will open up automatically when those two first steps will be achieved. So that's how we sit, which is a very similar story to the point you are making, to the Lipitor one, which I have experienced in the past.
Elias Zerhouni -- President, Global R&D
And if I can add, Olivier, something important: safety. Over the past two years, we have had exposure for tens of thousands of patients. The safety [inaudible] is good. And I think that's another consideration for any new medication that cardiologists are sensitive to. So as the time goes by, our safety record is established, all the issues that may have been a concern two years ago have sort of gone away, both from the physician's side of things and the payer's side of things. So I think personally that the data will be driving what Olivier just talked about. I don't know, Stefan, if you want to add.
Stefan Oelrich -- Executive Vice President, Diabetes & Cardiovascular
Stefan here. Maybe just one last comment. We've seen very recently with other product medicines in the cardiology space, that once guidelines were adapted that you would see a clear inflection point in the uptake. And we would expect something similar here. So it's the evidence that will guide use of the product and I think that makes good sense.
Elias Zerhouni -- President, Global R&D
And I think just for the record, the guidelines are generally expected when you have two studies, like having two Phase 3s within about six months of the result application, which is why we wanted to make sure we were published by the ACC.
Olivier Brandicourt -- Chief Executive Officer
Thank you both. Dupixent, Bill?
Bill Sibold -- Executive Vice President, Sanofi Genzyme
Yeah, so just in thinking about Dupixent and the growth, we're still at the beginning of Dupixent. We've, I think, set a great base in the U.S. We have over 8,500 prescribers. And just a little perspective there. Approximately 50% of the prescribers have greater than or equal to two patients prescribed. So there's clearly an opportunity in the U.S. to go much deeper in atopic dermatitis and we think, as physicians get experience with the product, that that's exactly what they'll do. We'll be augmenting that with continued education, working at an access level, and as Olivier mentioned, we'll be doing increased direct-to-consumer. So we think that that's one of the growth engines.
Now, also it's going to be geographic expansion as well. We launched in Germany in December, the Netherlands in January, Denmark in February. We have Canada and Japan launching shortly and then 11 additional EU countries in 2018. So just by virtue of the geographic expansion, we're going to see continued growth. And then ultimately at the end of the year, we add asthma. And then you do it all over again with asthma in all the countries and then additional indications. So we see that there's going to be steady reason for growth with the product and we are still very early.
Olivier Brandicourt -- Chief Executive Officer
Thank you very much, Bill. Last question please.
Operator
Final question comes from the line of Jack Scannell with UBS. Please go ahead.
Jack Scannell -- UBS -- Analyst
Hey, thank you very much for taking my question. I've just got a question about a very interesting chart that Bioverativ was showing financial markets shortly before your agreement to acquire them that suggests, in their worldview, by between 2021 and 2022, you have around 50% of Factor VII in their territories, or 50% of short-acting or regular half-life Factor VII having shifted to something else. And Bioverativ having about 25% of patients and then all other extended half-life Factor VIIs and Emicizumab having the remaining 25%. So my question is, is that a sort of future of the world that you share? And secondly, how sensitive was your evaluation of Bioverativ and the economics to those kinds of assumptions?
Olivier Brandicourt -- Chief Executive Officer
Okay. So Bioverativ assumptions versus what you have described. Bill?
Bill Sibold -- Executive Vice President, Sanofi Genzyme
Yeah, look, so I don't have --
Jérôme Contamine -- Executive Vice President and Chief Financial Officer
Can I just say, because the transaction is not closed, so we can't make comments. And you will see that 14B9 of Bioverativ will be filed maybe in the coming days. So I would like to warn that there is a limit to what we can say here.
Olivier Brandicourt -- Chief Executive Officer
Right. So a limit to what extent?
Jérôme Contamine -- Executive Vice President and Chief Financial Officer
I mean, you can make some comment how you feel but you are not going to compare what they say versus what we say because clearly it's one of the things which has led to this agreement that we have struck with them which are being followed by the offer that is still going to be launched now.
Olivier Brandicourt -- Chief Executive Officer
Right. So we can probably describe the assumptions that we have made. We have spent a lot of time on evaluating that market. Clearly the growth is coming from, and I'm sure you know that coming from short-acting and on-demand to the long-acting Eloctate and our products in that case and prophylaxis. We are seeing those, too, with the penetrations they have, becoming standard of care over time. I know that there was a lot of questions related to the products from Roche and Limra and its role in non-innovator. We believe that it's going to be a very important product for patients with inhibitors. We see that being much slower over time, that penetration in the non-individual populations.
So that's roughly the development we see in that market, which is growing by 7% which I mentioned earlier, which is a $10 billion market. So we're very, very confident that, with the current Eloctate and our products plus what you heard from Elias in terms of development and the XTEN technology which is going to bring that half-life much further and allow to have utilization or injection every week or even further, we really think that there is a very bright future for those two assets in hemophilia. So that's what I would say.
Jack Scannell -- UBS -- Analyst
Thank you very much.
Olivier Brandicourt -- Chief Executive Officer
Thank you. So I think that closed the call. Thank you very much for your questions and talk to you soon. Thank you.
Operator
Ladies and gentlemen, the conference is now over. Thank you for choosing Chorus Call and thank you for participating in the conference. You may now disconnect.
Duration: 84 minutes
Call participants:
George Grofik -- Vice President, Head of Investor Relations
Olivier Brandicourt -- Chief Executive Officer
Elias Zerhouni -- President, Global R&D
Jérôme Contamine -- Executive Vice President and Chief Financial Officer
Karen Linehan -- Executive Vice President, Legal Affairs and General Counsel
Bill Sibold -- Executive Vice President, Sanofi Genzyme
Stefan Oelrich -- Executive Vice President, Diabetes & Cardiovascular
Alan Main -- Executive Vice President, Consumer Healthcare
Vincent Meunier -- Morgan Stanley -- Analyst
Peter Verdult -- Citigroup Global Markets -- Analyst
Florent Cespedes -- Société Générale -- Analyst
Graham Parry -- Bank of America Merrill Lynch -- Analyst
Philippe Lanone -- Natixis -- Analyst
Jo Walton -- Credit Suisse Securities -- Analyst
Seamus Fernandez -- Leerink Partners -- Analyst
Jack Scannell -- UBS -- Analyst
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