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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2015 - Q1
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Executives

Sébastien Martel - Head, Investor Relations Olivier Brandicourt - Chief Executive Officer Jérôme Contamine - Executive Vice President and CFO Elias Zerhouni - President, Global R&D Peter Guenter - Executive Vice President, Global Commercial Operations Olivier Charmeil - Executive Vice President, Vaccines David Meeker - Executive Vice President and CEO, Genzyme Carsten Hellmann - Executive Vice President, Merial Anny Kykiaki - Operations Manager.

Analysts

Michael Leuchten - Barclays Vincent Meunier - Morgan Stanley Steve Scala - Cowen Jo Walton - Credit Suisse Florent Cespedes - Société Générale Graham Parry - Bank of America Tim Anderson - Sanford Bernstein Alexandra Hauber - UBS Philippe Lanone - Natixis.

Operator

Ladies and gentlemen, welcome to the Sanofi First Quarter 2015 Results Announcement Conference Call. I will now hand over to Mr. Sébastien Martel, Head of Investor Relations. Sir, please go ahead..

Sébastien Martel

Thank you. Good morning and good afternoon to everyone. And thanks for joining us to discuss Sanofi's financial results for the first quarter 2015. As always, the slides to this call are available on the Investors page of sanofi.com.

Before we begin, as you can see on slide two, I’d like to remind you that information presented in the call today will 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 documents on file with the SEC and also our document reference for a description of these risk factors. You can see on slide five, sorry, you can see on slide three, the agenda for the call. So we expect the call to last about an hour today.

With us on the call are Olivier Brandicourt, our Chief Executive Officer; Jérôme Contamine, Executive Vice President and Chief Financial Officer.

Also joining us for the Q&A session will be Elias Zerhouni, President of Global R&D; Peter Guenter, Executive Vice President, Global Commercial Operations; Olivier Charmeil, Executive Vice President, Vaccines; David Meeker, Executive Vice President and Chief Executive Officer, Genzyme; and Carsten Hellmann, Executive Vice President for Merial.

So without any further ado, I will now turn the call over to Olivier..

Olivier Brandicourt

Thank you, Sébastien. Good morning and good afternoon to everyone who has joined our conference call today. I am going to say, I am very privilege to be here today representing the company with such a long standing history of success in the healthcare industry.

As you all know, I joined Sanofi on April the 2nd, has been a great first weeks, providing me with many insights. And let me start off today’s call by sharing what is likely of most interest to you which are my near-term priorities.

First, I have started to work closely with leadership teams, both in Europe and in the U.S., in particular across the commercial pharma organization, Genzyme and R&D. I will be in China and Japan next month.

And I want to go deep into the organization to learn more about our people, prophecies and capabilities, because I want to understand the challenges and opportunities laying ahead. We will also lead company through a strategy review of its businesses which is already underway in parallel.

Second, I am intensely focused on the successful launch of multiple new medicines and vaccines. Next, I will make sure that we continued the strong momentum with R&D and focus on driving innovation.

I have already met our teams in the Boston and Frankfurt R&D hubs, and with Regeneron and have also plan the deep dive on our R&D pipeline in the next few weeks. And lastly, I will engage soon with Sanofi’s key shareholders around the world to better understand their expectations.

I also wanted to take this first opportunity to share with you why I decided to join Sanofi and some of my initial observations. Sanofi is diversified healthcare company which is well positioned within our fast evolving industry and benefits from established leadership in its main business areas.

From the distance in my 28 years of experience in this industry, I have observed Sanofi as a company with great commercial strength and excellent marketing capabilities.

Sanofi is a company with the stronger heritage of commercial success with product such as Plavix, Lovenox, Taxotere and Lantus, which have significantly improved the standard of care for the treatment of both serious disease and chronic conditions.

So looking forward, I can see similar opportunities at Sanofi again today and just to name a few examples, new medicine such as Praluent in hypercholesterolemia, the dengue vaccine and dupilumab for atopic dermatitis and asthma, all have the potential to be ground breaking therapies.

I also acknowledge the significant transformation of Sanofi’s R&D organization over the past few years and recognize the efforts to further bolster the pipeline. In addition, I have been impressed by the open to external integration of our R&D teams. This is evidence by our close collaboration with our partners such as Regeneron and Alnylam.

Beyond Sanofi’s innovation pipeline that address a significant unmet medical need there are complimentary ways to innovate, while maintaining financial discipline, smart life-cycle plans and post-marketing studies can lead to a dramatic improvement in medical practice.

I also believe in commercial and marketing innovation, including integrated patient solutions, such digital solution or line extensions in specific business segment. In order to realize our full potential, I feel personally energized to engage with the people and teams of this company.

Engagement of our employees as we know is a responsibility of the management team and high employee engagement is usually directly related to the performance. Therefore, I will strive to transform this high level of engagement at Sanofi into measurable achievements.

In my early weeks, I have observed first hand, the relative complexity of the organization and believe that there is opportunity for simplification along the way. However, this relative complexity will not be an impediment for us to reach operational excellence in the short and medium-term.

Next, I know that you may have questions about the level of diversification and strategy. I won’t attempt to answer these questions today. However, the Board and I are fully aligned around executing Sanofi’s diversified business model. Clearly, we want to compete in businesses where we will win.

As we perform a thorough business review over the coming months, we will keep an open mind regarding further opportunities to optimize the company’s portfolio.

We will share our thinking at the Business Update Meeting with the financial community at the appropriate time likely in the second half of this year and we will be in a position to announce the exact date at the time of our Q2 conference call. In the meantime, I will ensure that we deliver on our commitments to shareholders.

As Jérôme will discuss with you in a minute, Sanofi has the good heart, the good start to 2015. This business momentum provides a solid foundation for the launch of our new products throughout the year, I personally will take an active role to maximizing the potential of this critical launches.

Starting with Genzyme, we recently launched Cerdelga, the first oral therapy for Gaucher disease, strengthening our Gaucher franchise and reinforcing our leadership position. I’ve visited Genzyme two weeks ago and following my visit, I was struck by Genzyme’s unique culture, which has a patient at the heart of everything they do.

This patient centricity has already had a positive influence of the broader Sanofi organization. Genzyme is also making great progress in expanding in multiple sclerosis with Aubagio, our oral MS therapy and more recently with Lemtrada, the highly innovative treatment for multiple sclerosis recently launched in the U.S.

Lemtrada sales in Q1 exceeded full year 2014 sales and Genzyme continues to focus on training, certification and market access. In February, Afrezza the new inhaled insulin was also launched in the U.S. market.

It’s only been a couple of months since the launch, because of requirements imposed by FDA for starting patients on this therapy and the necessary time to gain market access, it will take time for Afrezza to demonstrate its full potential.

Just a few weeks ago we also launched Toujeo, our new once-daily long-acting basal insulin, which was approved by the FDA. Earlier this week we received approval for the -- from the European Regulatory Authorities, our diabetes team in Europe is also excited about the prospect of Toujeo. In my second week, I met with the U.S.

diabetes team in Bridgewater, New Jersey, and we had an extensive discussion about the launch progress. I was reassured by the commercial readiness of the team and I am pleased to share with you today, that we have made significant progress on market access and have already signed several contracts with payers.

Indeed, we recently refined our contacting strategy and have started to secure earlier and broader market access than expected. As of May 1, 2015, we will have more than 17% of commercialized cohort with unrestricted access, as well as around 45% of lives in Medicare Part D plans.

As a result, we expect the first quarter performance in diabetes of low single digit decline in sales at constant exchange rate to be indicative of full year 2015 performance of the global diabetes business. As early as July 24th, we expect to hear from the FDA on their regulatory decision for Praluent for hypercholesterolemia.

This new monoclonal antibody has the potential to be a revolutionary new treatment option for patients with high cardiovascular risk. While we made great progress in treating patients with hypercholesterolemia with statins in the last 20 years, cardiovascular death remains a leading cause of death in most countries. In the Amgen U.S.

patent lawsuit concerning alirocumab, we recently have received a scheduling order that sets a trial date of March 7, 2016. The judge stated that in the lieu of preliminary injunction proceedings the court has granted Amgen an expedited trial date.

Moving on to vaccines, I am also proud today to see Sanofi Pasteur as a leading edge of making dengue the next presentable disease through our vaccination.

We have now extended our rolling submissions into endemic countries in Latin America and we anticipate a first licenses to be granted in countries in Asia and Latin America in the second half of 2015. The current dengue fever outbreak in Brazil reminds us of the significant unmet need we are targeting with this vaccine.

Sanofi Pasteur also expects an FDA decision on PR5I, our hexavalent pediatric combination vaccine during the third quarter of this year. It could become the first vaccine in the U.S. approved to help protect against six important disease including Hepatitis B. As you know, we have other exciting late-stage pipeline opportunities in the near term.

Our next R&D milestones for this year include regulatory submission of lixisenatide, our GLP-1, in the U.S. expected in the third quarter, following the positive ELIXA cardiovascular outcome data. Upcoming Phase III results and expected regulatory submission of our insulin glargine lixisenatide combination project, LixiLan, in the fourth quarter.

And the upcoming pivotal data and the expected regulatory submission of sarilumab in rheumatoid arthritis before year end. Last but not least, we are pleased that Phase III trial for dupilumab in severe to moderate asthma has now started. This is the second indication of dupilumab after moderate and severe atopic dermatitis.

As you know, dupilumab has obtained breakthrough designation in AD. As we present our Q1 results today, I’m pleased that Sanofi has delivered both top and bottomline goals despite the previously announced headwinds facing Lantus into U.S. This shows our strength and the value of our diversified business model.

With that, I will hand the call over to Jérôme to walk you through the financial details of the first quarter and given that I’ve joined the company just four weeks ago, he will also discuss the operational performance of the businesses in the quarter. Jérôme, over to you..

Jérôme Contamine

Thank you very much, Olivier and good morning and good afternoon to everyone. So to begin and now moving and turning to slide eight, let me start by saying again that we are pleased with the performance of the group in the first quarter of 2015.

Sales were €8.8 billion for the quarter, our business EPS was €1.32 per share, up 2.4% and 2.6% respectively at constant exchange rates. As you noticed as well, these both performance are ahead of consensus.

Looking at the slide you can see much stronger growth on a reported basis than at constant exchange rates of both top and bottomline due to the favorable currency impact for the quarter. This is highlighted in the grey bars.

As you can see from the chart on the right side, business EPS was better than what we anticipated for the quarter when we discussed our full year results back in early February.

Actually, while diabetes sales were in line with our expectations, we had higher sales, in particular, from Genzyme on Merial as well as favorable situation in some emerging countries in particular, Venezuela on tight control of our expenses.

As we move now to slide nine, let me provide you with the details of the FX impact on the top and bottom line over the past five quarters. As you -- you will remember, the currency impact turned positive into the last quarter of 2014 mainly due to the strengthening of the U.S. dollar compared to the euro.

As you can see, this trend accelerated in the first quarter of 2015. Sales were positively impacted by €782 million or 9.9% in the quarter. At a business EPS level, we also experienced a positive currency impact of 10.2%, €0.12 in the same period.

Of the currencies impacted sales in the first quarter primarily included the Chinese Yen on the positive side and the Russian Rouble on the negative side. So clearly on the reported basis, Sanofi benefited from the strong currency tailwind in the first quarter of 2015.

Of course, we cannot particularly generate movements that when you apply average exchange rates of March 2015 to the three remaining quarters of the year, the additional positive FX impact on 2015 business EPS is committed now to be approximately plus 12%.

As always for additional information on ForEx sentivities to key currencies, which may help you refine your modeling exchange rates evolved during the year, please refer to the first slide in the finance appendix of the slide deck.

Moving to slide 10, I will give you now some more color on our sales performance by business areas following as you can see the comprehensive reporting structure of the group as it is normally presented in our quarterly press releases.

As you can see, our diversified business model continues to deliver, with sales growth driven mainly by Genzyme, animal health and to a lesser extent consumer healthcare. This positive momentum was partially offset by the anticipated decline in some other areas as we are going to discuss now.

Going through these businesses individually, first of all total pharmaceutical sales were up 2.2% at constant exchange rates this quarter. As expected, our diabetes sales were down slightly by 3.2% at consolidation rate, affecting the anticipated pricing pressure on Lantus in the U.S. market. It was exactly in line with consensus.

As previously communicated, increased rebates from most contracts in the U.S. for Lantus were required to secure favorable formulary position and became fully effective at the beginning of 2015. Consequently, the impact of higher rebates is visible from Q1 of this year. While the market share of Lantus in the U.S.

remains stable compared to the first quarter, U.S. Lantus sales were down 13.1% in the quarter versus Q1 last year. Of that, volume increased 2% and price was down 15%. For Lantus, the impact on the price is expected to remain at the similar level of the remaining quarters in 2015.

Outside the U.S., Lantus sales grew again plus 18% in emerging markets and plus 3% in Western Europe in the quarter. Moving onto consumer healthcare, we are pleased by the robust mid single digit growth delivered in the quarter, which is slightly above market growth. We benefited from a solid performance of Allegra in the U.S.

ahead of the spring allergy season and we saw good growth for our CHC business in emerging market, up 6.3%. Genzyme definitely delivered another outstanding quarter with 30.9% growth. This reflects our sustained leadership position in rare disease with continued success of Cerezyme, Fabrazyme and Myozyme.

We are also pleased with the initial launch progress of Cerdelga, contributing to the growth of Gaucher disease franchise. Overall, sales of the rare diseases business were up plus 15.9% at constant exchange rates in the quarter.

The other main driver of Genzyme exceptional growth is our multiple sclerosis franchise as already mentioned by Olivier, with Aubagio in the U.S. and is sold out in Europe as well as the launch of Lemtrada in the U.S. and Europe.

Sales of the multiple sclerosis franchise were more than doubled during the quarter, representing a trajectory of blockbuster potential of the franchise in 2015. Sales of generics which reached €478 million growing 10.2% at constant exchange rate. Emerging markets represented 58% of our global generic sales and grew at 12.7% at constant exchange rate.

First quarter growth of our oncology business was impacted by generic competition for Taxotere mainly in Japan that also in some emerging countries. As a result, oncology sales were down 7.3% at constant exchange rates as well. Established Rx brand sales were close to €3 billion but slight decline of minus 1.5% at constant exchange rate.

In emerging markets, sales of products in this category were approximately €1.1 billion, up 9% in the quarter while in mature markets, sales were just over €1.8 billion, down 7%. Please note that we expect generic versions of Plavix to enter the market in Japan as of mid 2015.

As we previously indicated during our full year results call, vaccine sales declined in the first quarter resulting from a delay in the Southern Hemisphere influenza campaign due to two strange -- two strain solid changes. Consequently, Sanofi Pasteur sales were down 4.6% at constant exchange rates.

Excluding flu, however, vaccines showed growth of 17.2%, driven by the performance of Pentacel and Menactra in the U.S. as well as Pentaxim in China.

Please keep in mind that in second quarter 2015, the Butantan Institute in Brazil will start to supply a significant part of the Brazilian flu market as a result of the technology transfer agreement with Sanofi Pasteur initiative 15 years ago. Sanofi Pasteur will continue to contribute to the Brazilian flu market but to a lower extent.

Now, looking at the full year 2015 and excluding dengue vaccine sales, Sanofi Pasteur expects yearly sales growth to be in the same range as last year. Our Animal Health business delivered growth of 13.5% at constant exchange rates in the first quarter, reaching record quarterly sales for Merial.

This reflects strong sales of NexGard in the U.S., which more than doubled versus the first quarter last year, stabilization of Frontline and strong performance of Heartgard, benefiting from the supply shortage of the competitors.

From the full year 2015, Merial does not expect to really sustain this double-digit sales growth, taking into account somewhat more competitive environment in pets and lower relative growth of NexGard for the remainder of the year than the first quarter due to a larger base for comparison in the prior year.

Still, Merial will post sales growth, which should be in the same range as last year. Turning to slide 11, you can see that our businesses are also well balanced across geographies, which you know. Sales are roughly divided one-third in the U.S., one-third in emerging markets and one-third in Western Europe and rest of the world.

Indeed, our global diversification as always been the core strength of Sanofi. Emerging markets were up 7.3% at constant exchange rates in the first quarter. All sub regions of emerging markets delivered positive growth during the quarter.

In Venezuela, consumer buying patterns resulted in a significant phasing of sales in the quarter -- in the first quarter but is expected to reverse in the remaining quarters of the year. Sales in Venezuela were €200 million in the first quarter of 2015 versus €66 million in the same period of 2014.

This was partially offset by lower sales of infant vaccines in emerging markets as I mentioned already, which were €20 million in the first quarter 2015 compared to €105 million in the same period of 2014. So excluding these items, emerging markets growth were up 7.3% in the period.

Please note also that our emerging market sales of the pharma business have been up more than 10%. We saw a continued stabilization of our sales in Western Europe and in the U.S., the sales were up 1% at constant exchange rates despite lower Lantus sales.

Sales in the rest of the world region were down due to loss of exclusivity for a certain number of products in Japan, including Taxotere, Merial [indiscernible]. As I mentioned already going forward, we also expect genuine competition for Merial to enter the markets in Japan in the middle of the year.

Now, I move to slide 12 to discuss certain items relevant to the P&L in the first quarter. I already commented the sales of €8.8 million, up 2.4% at constant exchange rate. Other revenues were €18 million, a decrease of 14.5% at constant exchange rate due to a loss of most royalties received on Enbrel European sales.

First quarter gross profit was €6.1 billion, up 1.8% at constant exchange rate as cost of sales increased only 3.1% at constant exchange rate. We come back to revolution of our gross margin and our OpEx in the next slides. Of note, the other current operating income and expense line include an FX loss of €66 million in connection with Venezuela.

Lastly, our partnerships income increased to €31 million, up €13 million mainly due to the partial consolidation of an ownership of Regeneron, which is now accounted as with the equity method, which was not accounted to a certain methodology in the first quarter last year.

Consequently, we saw moderate business operating income growth in the first quarter, up 2.1% at constant exchange rate to €2.4 billion. All considered, business operating margin declined by only 20 basis points to 27.2% in the quarter, despite lower sales of Lantus in the U.S. and as expected, higher SG&A expenses in Q1 2015.

I will now move to the slide 13 quickly. So looking at the low part of the first quarter P&L.

You can see that net financial expenses were slightly higher as compared to the same period of the previous year because as a result of the capital gain of €41 million that we booked in first quarter 2014, due to a partial sale of some financial investment versus capital gain of only €16 million from various small financial investments in the first quarter of this year.

The effective tax rate was 25% in the first quarter of 2015, which was stable versus the first quarter 2014. Our businesses income in the first quarter was €1.7 billion. We delivered business EPS of €1.32 per share.

The average number of shares decreased by 11.5 million shares in the quarter to 1.308 million shares, compared to 1.319.9 million during the same period of 2014. Turning now to slide 14. You can look at the evolutions of the gross margin.

During the first quarter, we saw slight improvement in the gross margin, which increased 3 percentage points to 0.3% to 69.3%. I really believe that it is a good achievement and it most reflects the improvement of this year performance and positive impact of FX, which more than offset the impact from U.S.

diabetes and from our ramp up in biologics investments. We expect now for the full year, assuming that exchange rates remains at the same level of last 2’15, our gross margin to be between 68% and 69% for the whole year. In the next slide, we see that OpEx expenses increased 3.7% at constant exchange rate of €3.6 billion.

R&D expenses decreased by 1.8% during the quarter, due to the timing of clinical programs in 2015. This affect was more than offset by investments in new launches at Genzyme and U.S. Diabetes, as well as some marketing expenses in emerging markets. As a result, the R&D to sales ratio declined to 13.6%, while the SG&A to sales ratio increased to 27.7%.

For the full year of 2015, we continue to expect OpEx growth in mid single digits area at constant exchange rates. Slide 16, you can see that our net debt increased close to €7.6 billion, which includes a translation impact of our debt held in U.S. dollar, which represented the impact for the quarter of €593 million.

Free cash flow was just over €1.2 billion for the period. Our CapEx were €355 million versus €279 million in the same period last year, which is clearly due to our investment in biologics and also for sustaining the launch of Toujeo.

Our change in working capital was negative this quarter as a result of high inventory of the dengue vaccine of new products. During the first quarter, we continued to buyback 9.2 million shares of our own shares for €794 million. We also received proceeds of €247 million from the exercise of stock options and shares issuance.

All in all, we issued 6.9 million shares in the quarter, including 3.1 million requisite shares. The net impact from share buyback was a dividend of €547 million in the quarter. I will now move to my last slide, slide 17. So, I conclude by reiterating our outlook for 2015. Our expectations for 2015 business EPS remains unchanged.

2015 business EPS would be stable to slightly growing versus 2014 at constant established exchange rates bearing major unforeseen type of event.

As highlighted before on top of that, the positive currency impact on 2015 full year business EPS is estimated now to be approximately plus 12%, assuming that exchange rates remain stable in the following three quarters at the average rates of March 2015. I would now turn back the call over to Oliver for his conclusion..

Olivier Brandicourt

Thank you, Jérôme. Let me wrap up the presentation with a few concluding remarks on slide 19. So we indeed had a good start to the year. First, we delivered topline growth with sales up 2.4% at constant exchange rates, thanks to the solid performance of Genzyme and Merial and the despite lower U.S. sales of Lantus.

Then, we also posted strong financial results. Despite higher OpEx driven by new launches, our business EPS was up 2.6% at constant exchange rate.

And lastly, as I mentioned earlier, we made great progress in bringing innovative medicine to market, with important milestone achieved for late stage R&D projects and multiple new product launches underway are imminent. At this point, I would like to turn the call back to Sébastien to open the Q&A session..

Sébastien Martel

Operator, we are now ready to open the call to questions. As always, I will ask you to limit yourself to one or two question at a time to allow as many participants as possible in the Q&A session. You can always return to the queue if you have further questions..

Operator

Thank you. [Operator Instructions] We have a first question from Michael Leuchten, Barclays. Please go ahead..

Michael Leuchten

Thank you. It’s Michael Leuchten from Barclays. Two question for me, please. One for Olivier. The Capital Markets Day in the second half is setting yourself quite an ambitious timetable to communicate your view of the company’s strategy and positioning going forward.

But one of the challenges I think in the recent past has been accountability within the organization.

So, I’m just wondering, are you thinking around the timing and then secondly how are you thinking will it be addressing the softer factors as opposed to the hard monitoring of launches and maybe R&D productivity? And then the second question for Jérôme.

I appreciate your comment around the operating expenses, still expect to grow 5% in the full year but it did grow less than that in the first quarter and if we think about the timing of the additional launches coming through where exactly do you expect that acceleration to kick in on the operating expense side, please? Thank you..

Olivier Brandicourt

Michael, unfortunately, it was not clear. We couldn’t listen very well or hear very well, sorry. I understand the Capital Market Day. As I said in my remarks, we think we are going to do that in the second half. I really need to go through deep business reviews. As I said, we’ve launched this strategic planning review also in parallel.

We think we may have those results sometime during the second half, most probably during the third quarter -- fourth quarter, sorry and we will give you the exact date during our call for the second quarter.

And the question on comps, really I’m not sure I understood what you usually said in this organization, accountability has not been usually very clear. Well, let me tell you one thing. If that is the case and I’ve not seen that yet, I’ll make sure that it doesn’t last too long..

Jérôme Contamine

Yeah. Michael, so on OpEx as you noticed, I mean, our OpEx in the first quarter increased by 3.7%. I continue to guide around 5% increase in the mid-single digits, so not ask me to be too precise but let’s say around 5% OpEx increase for the all year. So here, I mean two things. I mean OpEx, R&D plus SG&A.

So on R&D clearly, I don’t think the pattern of decreased net R&D expenses, which you saw in the first quarter will be repeated in the next quarter. Clearly, we have a large clinical trial program and we expect to see that increasing somewhat on the call this year what we gave as a full year guidance when we had the call in February.

When it comes to SG&A, I won’t go into too much detail but maybe you should recall a few things. First of all, we have now fully hedged sales and marketing organization for Lemtrada, which has its own sales force. And this happened to took place in the second half, this time basically in the fourth quarter.

So, on a like-for-like basis, it will continue to impact our OpEx evolution in Genzyme between quarter-to-quarter. Second, clearly we are going to invest more beyond the preparation of the launch of Praluent, as we go and even more if we launch it, we clearly expect to get that and take place in second half of the year.

And then as you know, I mean, there is also some seasonality in the OpEx and whether you take vaccine or you take Merial. It’s not just a regular evolution. So altogether, I mean there is nothing really new here.

We need to invest in sustaining the launches of these very exciting products and also there are some mechanical effects, which are just resulting from investments we did on the full year impact we will have in the coming quarters..

Sébastien Martel

Thank you, Jérôme.

Next question, please?.

Operator

Thank you. The next question is from Vincent Meunier, Morgan Stanley. Please go ahead..

Vincent Meunier

Hello. Thank you for taking my questions. So the first one is on the U.S. diabetes trend.

So, I understand that the 15% price decline in first quarter will remain at similar level in the remaining of the year, so can you elaborate on the impact for Toujeo? I mean, what is for instance, the net price of Toujeo versus Lantus now and how it is likely to evolve in the next quarters? And the second question is on Genzyme, which is an important driver for you not only for the topline but also the bottom line.

Can you please give more details on the profitability of Genzyme? And should we expect the new product launches to cap further improvements of the profitability of Genzyme?.

Olivier Brandicourt

All right. Thank you, Vincent. So, I think the first question is for Peter. Peter, if you are ready to answer the question on Toujeo? And then David, you will take question on Genzyme..

Peter Guenter

Yeah. Vincent, so thanks for the question. A couple of points on Lantus Toujeo. So first, we have some very encouraging signs. It is now since five consecutive months, our overall market share over within the basal insulin market has stabilized at the level of 69% if you look at the Rxs.

As already mentioned by Olivier in the introduction, we are making extremely good and fast progress with market access and actually beyond our expectations. And that is actually due to a refinement, the recent refinement of our contracting strategy on the overall glargine franchise.

You will understand that I will not give you any details between the different elements of this mix for competitive reasons.

The key point really here is that on top of the stabilization of the Lantus market share, which obviously is the stable base now for the Toujeo launch and we have 70% of commercial lives covered without restrictions and already close to 50% of the Part D population, which is really according to our knowledge an extremely rapid access of the market.

And another point, I would like you to mention is that we have reissued our long-term guidance on diabetes which is flat to slightly growing, so there is no change in our long-term guidance on diabetes. And we continue to be absolutely convinced that these rates of Lantus to Toujeo will beat the consensus, which is today as you probably know at 20%.

Now in terms of initial feedback on Toujeo launch, obviously it’s really early days. We have launched our product since less than a month. What I can tell you is that the initial feedback from the customers is very good, which is frankly took us another surprise that we have a permanent in stream in the U.S.

market of $1 million patients on the yearly basis of new to be insulin eye inspections and these are obvious candidates for Toujeo. And then the next pool of patients is of course, those patients who are today not optimally treated with the existing basal insulin, whether that is Lantus or any other basal insulin.

Either for reasons of insufficient HbA1c control, either for reasons of high pose or a combination of both end and frankly it is of course obviously, often a combination of both.

And so on pricing, the only thing I can tell you on top of that is that the WACC price, so the wholesale of acquisition price is between Lantus and Toujeo is identical on the unit, per unit price. But of course, I will not give you anymore detail on that pricing..

Sébastien Martel

All right. Thank you, Peter.

David, are you ready to answer the question on Genzyme?.

David Meeker

Yes. So the Genzyme within Sanofi, we don’t breakout a full complete P&L. So we can’t give you exact profitability for Genzyme. Early R&D is carried on the corporate page and shared services also are carried on a corporate page. So like I said, the exact numbers are forthcoming.

What I can tell you is that the rare disease business is even when you do rough calculations, robustly profitable and that profitability is quite a stable situation and pricing as remained relatively stable. The other lines on the P&L have a certain level of stability.

So, I think that should continue to a bit profitable and robustly profitable and we continue growth on this good prospects for the rare disease business. The MS business, I’m launching two of these, both of these products in the past 18 months. And obviously there is a significant investment that goes along with that. We did turn profitable last year.

Even acknowledging, we don’t have full insight if you will into all aspects that might hit that P&L. But the MS franchise I think, Jérôme highlighted and we’re on track and fairly steep growth pattern here. And I think the profitability from this point forward should grow quite significantly for the MS business as well.

So absent numbers and those are the trends..

Sébastien Martel

All right. Thank you very much, David. Next question please..

Operator

Thank you. The next question is from Steve Scala, Cowen. Please go ahead..

Steve Scala

Thank you.

A couple on Toujeo, can you elaborate on the refined contracting strategy in the U.S.? And why a refinement was necessary and what is the refinement relative to? So for instance, is it refinement versus the strategy you had a year ago or is it a more recent shift? And related to that the prior guidance for Toujeo was well more than 20% of the glargine franchise in three years.

So based on this refined contracting strategy, are you ready to refine that estimate and maybe may get well more than 50% in three years? Thanks..

Sébastien Martel

Thank you, Steve. So that’s again for you, Peter..

Peter Guenter

Yeah. Steve, so thanks for the question. The contracting strategy is indeed a recent refinement of the contracting strategy.

And as I mentioned before, the strategic aim is really to speed up the market excess for Toujeo because we are fully committed and fully confident to the long-term potential of this product and of course, the strategic importance of not only having new patients but also searching patients from the existing Lantus to the new Toujeo.

In terms of where we should land, this is a very difficult question. We are today not ready to give you any precise number. But we remain committed what we said during the New Medicines Day that is to say, we are confident that we will have switch rates and well above the consensus that is out there today which is 20%.

And I remind you also that the access that we have already got it so far is without restrictions, which is of course also facilitating significantly the prescription by the physician..

Steve Scala

Thank you..

Sébastien Martel

All right. Thank you, Steve.

Next question, please?.

Operator

Thank you. The next question is from Jo Walton, Credit Suisse. Please go ahead..

Jo Walton

Thank you. I wonder if you could tell us a little bit about how Lantus is doing in Western Europe where you’ve had very strong growth for the past few quarters. Is this sustainable at the current level? And on Praluent, in the core case that you identified in March -- you identified it as March 2016 as of expedited date.

Does that mean that the court isn’t going to intervene at anytime before than because we would’ve expected both products to have been approved well before March 2016?.

Operator

Mr. David Meeker, can you please reply to the question? I’m reconnecting the other speaker. Thank you..

David Meeker

As the only one on -- again, I think we should wait until they join back since that’s on the diabetes Praluent business, so let’s give it a minute..

Operator

Ladies and gentlemen, thank you for holding we are reconnecting one of the speaker. Thank you.

Would you like me to take another question sir?.

Elias Zerhouni

Are we able to reconnect or....

Operator

We are still trying to contact the other speaker, we can take another question, if you would like?.

Elias Zerhouni

So obviously we can speak to Genzyme issues, but I think we should definitely try to reconnect here, we need to....

Anny Kykiaki

We are on a separate line here Elias..

Operator

We currently are unable to join the speaker.

Would you like to -- would you like us to give the floor to another question?.

Jo Walton

Should we try a question on Genzyme would that be better?.

Elias Zerhouni

Yeah. We can certainly do that again, I think, with 10 minutes to go on the call here, we should look to wrap it up, but they are not able to be on, I think, the -- it’s probably not worth trying to continue the full call..

Jo Walton

Well, if I can ask a question on Genzyme? I wonder if you could tell us a little bit more about the uptake of Cerdelga. You've obviously just launched it. It's been into a few countries.

Can you tell us where it's being used? Is it patient holidays? Just give us a little bit more of a sense of how quickly we could see that ramp up?.

Elias Zerhouni

Sure. Yeah. I think when we launched Cerdelga, the oral therapy for Gaucher disease. The spirit of that launch was that we created a choice for patients and the data show that it was highly comparable to Cerezyme or enzyme replacement therapy. And so we expect to going in that it would be the right option for some patients not for others.

So today we are pleased with our launch. I think, what I would encourage you to look at as I said last time as the overall Gaucher franchise, we are growing at over 10% at the current rate globally. In the U.S.

we have over 200 patients on therapy and the number of patients were going through screening for to make sure that they have the right mutation to be able to metabolize the drug that is also -- I think those numbers look good.

So, again, I might focus here as very much on the overall franchise less on the Cerdelga uptakes specifically, but I am please so far with where we are..

Jo Walton

Thank you..

Operator

Thank you. We have another question from Florent Cespedes from Société Générale. Please go ahead..

Florent Cespedes

Good afternoon, gentlemen. Thank you for taking my questions. Two quick ones, one for Olivier, one for Elias. First, for Olivier, in your previous company, we appreciated your pragmatic approach and your balanced view on the group. What could you do at Sanofi to....

Anny Kykiaki

Excuse me, I’ve got him on the phone, Elias.

Hello?.

Elias Zerhouni

Hi sorry..

Anny Kykiaki

Excuse me, can you hear me?.

Olivier Brandicourt

Anny..

Anny Kykiaki

Yes..

Olivier Brandicourt

You can you can hang up, we are -- we have reconnected we had major power break here in the Paris HQ officer..

Anny Kykiaki

Okay. Thank you..

Olivier Brandicourt

Reconnected into the call. Sorry, Florent you are going to have to repeat your question, Olivier..

Florent Cespedes

Okay. No problem. So for Florent Cespedes, Société Générale. Two quick questions, the first for Olivier. So as I said, in your previous company, we appreciated your pragmatic approach or your balanced view on the group.

Now, at Sanofi, what could you do to increase visibility on the group? Could you envisage maybe to give a kind of aspirational long-term guidance later this year during the Investor Day or something more kind of precise guidance like at Bayer, could we have your thoughts on that? My second question, for Elias.

Could we have more details on why you decided to stop the different projects in R&D in oncology, Crohn's and ophthalmology? Is it due to the lack of differentiation, safety or prioritization? Thank you very much..

Olivier Brandicourt

Yeah. All right, Florent. So your question, again, we couldn’t hear you very well, but it’s on the LT guidance latter this year. I mean to be honest it would be premature, right, for me to tell you that I am going to switch to guidance, it’s a same type of guidance we have and we had Bayer for instance.

I have to go through what I described a business review and strategic planning and come to a conclusion of how to best guide in future years. So it's definitely something I have in mind, that's certainly there, but you need to give me some time. And so, R&D, Elias..

Elias Zerhouni

Yes. So the question relates, if I heard it properly about the decisions we made in oncology. Fundamentally, we decide to focus on the promising programs the CD38 antibody program the or antibody drop conjugate programs we have and the c-MET kinase.

And as you mentioned, we -- I predictably reviewed all the other programs with the results, and somewhere primarily terminated because of lack of differentiated efficacy, we thought in a couples for signals that I didn’t think could be managed forward given the current environment.

And the third reason is we are also working on the very early portfolio immuno-oncology that we want to make some room for it, which we’ll talk about later..

Florent Cespedes

Thank you very much..

Olivier Brandicourt

Yes. So again our apologies, but as I just said before you, Florent, we had a power cut and at the time we had a question from Jo Walton on Lantus, so maybe Peter, if you want to take this one..

Peter Guenter

Yeah. So maybe, the part of the question we still received before the power cut was on the situation of Lantus in Western Europe and I guess, also by extension your question was also pertained to the overall Lantus, Toujeo. So a couple of points on Western Europe, so we are doing well, we are very pleased by the performance.

There is definitely no price increase in Europe rather a constant price erosion and we have again delivered more than 6% growth from Lantus in the first quarter and we are actually very competitive within the basal segments in quasi all the countries in Western Europe.

And for what concerns Toujeo and the good news is that Toujeo will in Germany not have to go through the unknown procedure and we have seen in the last couple of years especially in the field of diabetes some major drawbacks of diabetes drugs going through the unknown procedure. So that is a very good news. And a little bit like in the U.S.

by the way, we have made -- we have been making very strong progress on contracting with the German [indiscernible] with the German funds. So we are confident of having a good lift up in Germany.

Also that we got registration end of last week, we have a very competitive label this time in Europe and so all this makes us pretty confident actually on the European launch of Toujeo. And so that is a little bit the picture I can paint to you in nutshell for Europe..

Olivier Brandicourt

Thanks Peter.

We are going to take next question please?.

Operator

Thank you very much. The next question is from Graham Parry, Bank of America. Please go ahead..

Graham Parry

Great. Thanks for taking my questions.

So, firstly, Olivier, you've outlined your priorities for the near-term and discussed the strategic review? But could you give us a feel for the extent of that strategic review? So do you think the scope of the company, as it sits right now is about right? So is the review about thinking around the edges or is there something potentially more cathartic than this about to happen? And then secondly, on Toujeo, could you just give us a feel for initially where patients are coming from? Is this predominantly new patients or switches from Lantus and on the access, how much of that is Tier 2 preferred status or perhaps just in a same or better Tier than Lantus rather than just being unrestricted access? Thank you..

Olivier Brandicourt

All right. Thank you, Graham.

And since we are on Toujeo can you take the Toujeo question first?.

Peter Guenter

Yeah. Hi, Graham. So as I already mentioned in terms of patient sourcing, so there are two obvious segments, so its approximately 1 million new patients in the U.S. So this is for us the low hanging crew we are going after aggressively.

And also those patients that are not a goal experiencing high post-combination of both fear of hypos, and we have all programs in place actually to make sure that we maximize the revenue stream of these two segments. Your questions on market access Tier 2, Tier 3 is dependent from plan to plan, obviously, today there is a mixture of both.

In commercial you probably will have captured that we have a good effort in place with co-payment offset programs whether this is a classical couponing program or with a more automated co-pay offset program in the pharmacies, with Relay Health.

So actually the co-pay for the patient is very competitive compared to what is out there for existing base of insulins. And then in the Medicare Part D, actually, as it becomes public in the coming days, you will see a lot of actually tier two coverage..

Jérôme Contamine

On the strategic review, this is again going to be the subjects of the next few months. But I want to be clear when I was referring to for the second half of the year will be business update rather than a presentation on a strat plans for the overall group.

Now I have to say, that Board and I, we are already free aligned around executing what Sanofi diversified business models is. And we keep in mind that, while diversified, we want to complete in the business where we can and we will win.

So we’ll keep also an open mind regarding further opportunities to optimize the companies’ portfolio while we are doing that thorough business review and strategic review. So that’s what I can share at this point. So thank you, Graham. Next question please..

Operator

Thank you. The next question is from Tim Anderson with Sanford Bernstein. Please go ahead..

Tim Anderson

Hi.

I'm imagining that you'll say it's too early to comment on 2016 in terms of the outlook for the diabetes franchise, but investors are certainly looking past 2015 at this point and into 2016, because the landscape gets more competitive and I think more uncertain for Lantus and Toujeo with Lilly coming to market and with Novo probably coming to market.

Wondering if you can at least confirm directionally how you expect that franchise, your overall diabetes franchise, to perform in 2016? Would it be safe to assume that it would likely be lower in 2016 overall than what it would be in 2015? And second question for you is on dupilumab.

In the press release and the slide deck, you talk about various upcoming catalysts across the pipeline. I didn't see on there the first Phase III readout of dupilumab in atopic dermatitis.

I thought that might happen by year end, but can you give us updated timing for when investors might learn about the first -- the readout of that first Phase III trial?.

Jérôme Contamine

Well, I’ll answer the first -- Tim, the first question quickly. Our guidance is stable between 2015 to 2018 for diabetes business is concerned. So it’s stable, just slightly increasing. So that has no chance and to give you a more granular picture for 2016 at this point would be very difficult.

So the other question has to do is LixiLan or dupilumab? Dupilumab..

Olivier Brandicourt

Well, maybe, Peter, you want it say we’re about LixiLan and this is obviously part of the year outlook.

Tim Anderson

Year outlook..

Peter Guenter

Yeah. Tim so in the long term outlook, there are as you mentioned yourself, a couple of elements. There are competitive elements. There are elements of the increasing Sanofi portfolio in diabetes. Of course this price pressure on the market we have baked in all these elements in the long-term guidance.

And for example, if you think about the LixiLan now that we have ELIXA process positive study, and we would have the readouts of the LixiLan studies in the third quarter of this year.

We will file LixiLan of course as subject to a positive readout of Phase III by the end of this year, and LixiLan would therefore be the first and only fix those between basal insulin and the GLP-1 with proven cardiovascular safety and for the insulin and for the GLP-1. You know also that old products fit extremely well together.

Lantus is working on FPG, Lixi working on PPG so this is a very synergetic combination. So we can lift thing, this is one of the asset we have in the portfolio which is a little bit overlooked by some of your, I must say and we’re pretty excited by this product. And so I think I’ll turn it over to Elias for the question on dupilumab..

Elias Zerhouni

Yes. So, as you know we started Phase III in the fourth quarter ‘14, and our plans are to submit the application for dupilumab in the fourth quarter of 16. Also, you should know we started Phase III for asthma, and we remember we have a breakthrough designation for the FDA for atopic dermatitis. So those are our plans.

I can’t predict exactly when the Phase IIIs will finish, but that within the timeline that you requested..

Sébastien Martel

Thank you, Elias. We’re going to take a couple of more questions. So we’ve extended the call a little bit beyond what we said, given the power break we had. So, we will take two more and then disconnect the call. Next please..

Operator

Thank you. The next question is from Alexandra Hauber of UBS. Please go ahead..

Alexandra Hauber

Thank you for taking my question. I have a question for David first.

Given that a lot of the Lemtrada revenue occurred upfront, can you please maybe give us some idea about the addition of patients, what you see? Are they adding at a regular, similar weekly patient adds, or are they accelerating or was there a bonus upfront? And then secondly, Peter, sorry, if I come back again to the pricing question in diabetes.

So to summarize everything that I've heard so far is, on the one side, you're saying the 15% price effect will stay the same for Lantus through all this year, yet there has been a refinement in the contracting strategy which was required to change the guidance.

I therefore conclude that that refinement is related to Toujeo and therefore means greater discounts in the year than you had previously anticipated. Is that conclusion correct, or am I missing something? Thank you very much..

Olivier Brandicourt

All right. And thank you Alexandra.

David, Lemtrada?.

David Meeker

Yeah. There was no bolus upfront and I think the way we think about this is there is some certain mechanics and they go with Lemtrada launch, sound specifically the REMS programs.

So the first three months of launch of our post-approval period was intensively focused on getting healthcare providers on physicians, pharmacies, et cetera trained and certified in the REMS. So we made tremendous progress there. The full sales force was on board as of the beginning of the February.

So we’re basically into our third month of former launch in that sense and what we’re seeing is a steady ramp in the number of patients who are signing up for the program. In other words, the patients themselves have to enter the REMS program and that’s one of our sign there so.

So I would -- there's been -- there is no bolus of study ramp on the initial launch..

Sébastien Martel

Thank you, David.

Peter?.

Peter Guenter

Yeah, Alexandra. So I’ll make a try to answer as good as I could and any additional granular information would be giving away commercially sensitive information. So thank you for your understanding..

Alexandra Hauber

Thank you..

Sébastien Martel

We’re going to take one last question, Operator..

Operator

Thank you. The last question is from Philippe Lanone of Natixis. Please go ahead..

Philippe Lanone

Hello, gentlemen. Thank you for taking my question. A couple if I may. One for Olivier on Praluent, because obviously, you come from a company initially that has been a cholesterol leader.

How can you see -- can you give us more color on how you see the potential of that drug and how Sanofi is well prepared to launch it, keeping in mind that the current consensus is $1.8 billion? What are your ambitions on Praluent today? And second question, on the biosimilar insulin lispro, which is in Phase III, can you give us some calendar here for launching and how you will position that versus your other two short-acting insulins, Afrezza and Apidra?.

Olivier Brandicourt

Okay. Praluent, just to give you what I did and then let me answer your question. So I spent a fairly good amount of time, actually with the global and U.S. team, to just assess our preparedness for the launch. And I think we are refining few things but we are well on our way to be actually very ready for the launch.

So I feel that is your question, I feel pretty good that we’re going to puts onto market, of course, a very powerful medicine. But we’ll have prepare for -- we’ll be prepared for a very successful launch. So what is the second question is for you Elias..

Elias Zerhouni

Yeah. The question is just straight forward question about lispro. As you know our strategy has been to be a complete solutions provider for diabetic patients. And as you know, [indiscernible] was a part of that scenario.

So as part of the strategy, we think buying similar especially in different markets are going to be critical to provide that full spectrum if you will. And so that’s part of the strategy..

Philippe Lanone

Good. Thank you..

Sébastien Martel

Okay. Thank you, Elias. Olivier, we are now ready to close the call. Well, thanks very much to all participants for your interest today in Sanofi. And we look forward to talk to you very soon. Thank you everyone..

Operator

Ladies and gentlemen, this concludes this conference call. Thank you all for your participation. You may now disconnect..

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