Sanofi's (SNY) CEO Olivier Brandicourt on Q1 2016 Results - Earnings Call Transcript

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Sanofi SA (NYSE:SNY)

Q1 2016 Earnings Conference Call

April 29, 2016 08:30 AM ET

Executives

Sebastien Martel - VP, IR

Olivier Brandicourt - CEO

Jerome Contamine - EVP & CFO

Pascale Witz - EVP, Diabetes & Cardiovascular

Carsten Hellmann - EVP, Merial

Peter Guenter - EVP, General Medicine & Emerging Markets

Elias Zerhouni - President Global R&D

Olivier Charmeil - EVP, Vaccines

David Meeker - CEO, Sanofi Genzyme

Karen Linehan - EVP, Legal Affairs & General Counsel

Analysts

Florent Cespedes - Societe Generale

Jo Walton - Credit Suisse

Tim Rice - Deutsche Bank

Michael Leuchten - Barclays Capital

Philippe Lanone - Natixis

Steve Scala - Cowen & Company

Peter Verdult - Citigroup

Vincent Meunier - Morgan Stanley

Graham Parry - Bank of America/Merrill Lynch

Seamus Fernandez - Leerink Partners

Operator

Ladies and gentlemen, good afternoon, welcome to the Sanofi Q1 2016 Results Conference Call and live webcast. I am Moira, the Chorus Call operator. I would like to remind you that all participants will be in listen-only mode, and the conference is being recorded. [Operator Instructions] The conference must not be recorded for publication or broadcast.

I would now like to turn the conference over to Mr. Sebastien Martel, Vice President, Head of Investor Relations at Sanofi. Please go ahead, sir.

Sebastien Martel

Thank you, Operator. Good morning and good afternoon to everyone on the call. Thank you for joining us to review Sanofi's first quarter 2016 results. As always, the slides for this call have been posted on the Investor's page of our Web site at sanofi.com.

As you can see on Slide 2, I'd like to remind you that information presented in this call contains forward-looking statements that involve known and unknown risk, uncertainties, and other factors that may cause actual results to differ materially. I refer you to our Form 20-F document on file with the SEC and also our document referenced for description of these risk factors.

With that, please advance to Slide 3, and let me introduce our speakers on the call today. With me are Olivier Brandicourt, our Chief Executive Officer, and Jerome Contamine, our Chief Financial Officer. Also joining us today for the Q&A are the heads of our five global business units, Olivier Charmeil, Peter Guenter, Carsten Hellmann, David Meeker, and Pascal Witz. We also have Elias Zerhouni, President, Global R&D, as well as Karen Linehan, our General Counsel, today on the call.

Now, before we begin, let me tell you that as usual, Olivier will discuss the key highlights of the first quarter of 2016 and then Jerome will review Sanofi's financial results. After that we'll open the call to Q&A.

Before we start, I'd like to highlight some important accounting items affecting the first quarter, and there are three of them. First, I'd like to remind you that, as a result of the announcement of excluding negotiation with Boehringer Ingelheim on the potential asset swap, certain changes in the way we report and present our results are required. On the current IFRS accounting standards, we need to report animal health separately as a discontinued operation. However, to help with your year-over-year comparisons, we will use the term aggregate, which simply means that our animal health business is included in our financial results line as before.

Second, please note that a portion of the revenues from VaxServe, which is Sanofi's vaccine distribution and service provider in the U.S., has been reclassified from sales to other revenues from January 1, 2016. This reclassification relates only to those revenues from VaxServe which are generated by the distribution of third-party vaccines and products. In order to ensure the comparability of VaxServe's sales of non-group products and services year-over-year, prior period comparative net sales have been reclassified to the line other revenues accordingly. We believe that this reclassification provides you with a better understanding of the key drivers of our vaccines business.

And lastly, given that there has been no indication of improvement in the economic situation in Venezuela, Sanofi has decided to change the FX rate used for the Venezuelan bolivar. Sanofi now uses the DICOM exchange rate of 273 Venezuelan bolivar per U.S. dollar, this new exchange rates replaces the official CENCOEX rate of 6.3 Venezuelan bolivar per U.S. dollar, which was used in the first quarter of last year.

With that, I'd like to turn the call over to Olivier.

Olivier Brandicourt

Thank you, Sebastien. Good morning, good afternoon to everyone, and welcome to our first quarter 2016 earnings conference call. Starting with Slide Number 5, I'm pleased with our performance in the first quarter and the progress we have made on our 2020 roadmap. First, as you have seen, we reported solid financial results with aggregate sales of €8.5 billion and EPS growth of 5.3% at constant exchange rate to €1.34.

Second, we continued to move forward with the reshaping of our portfolio. As you saw from our news release yesterday, we have recently made a nonbinding proposal to acquire Medivation. We believe combining Sanofi and Medivation would bolster our oncology franchise and generate value for shareholders of both companies. We already have a presence in prostate cancer with Jevtana, and this transaction would broaden our portfolio in this important indication and potentially add two oncology assets in clinical development. This proposed combination has an attractive financial rationale, and would be immediately accretive to earnings. We will, of course, continue to be financially disciplined during this process.

We decided to go public yesterday, because Medivation management was, unfortunately, unwilling to engage, and we felt that shareholders of both companies should be informed about our proposal. Beyond this statement, it would be premature to make further comments today, and I would therefore ask participant on the call to respect the sensitivity of this situation and to keep questions limited to those pertaining to the first quarter.

Moving to other business reshaping activities, as you know, we are currently in exclusive discussions with Boehringer Ingelheim, and I'm pleased to report that the deal is expected to be signed mid-year and to close by year-end. In vaccines, we decided to add our joint vaccine operations with Merck in Europe by year-end. With this decision, we will be able to pursue our own growth strategy for vaccines in this important geography.

Third, we remain focused on our key launches. In diabetes, Toujeo continues to capture market share in the U.S. and in Europe. For Praluent, we continue to see a limited uptake in the markets where it has been launched. We are working with payers and physicians on ways to make it easier for patients to have access to Praluent in the U.S. and Europe, and to benefit from this innovative medicine.

Dengvaxia, the first Dengue vaccine has now been approved in four countries including Brazil and Mexico. Importantly, the first public Dengue immunization program has started in the Philippines in April. I'm encouraged by the recent recommendation by the Strategic Advisory Group of Expert on immunization to the World Health Organization to use Dengvaxia in endemic countries. This important recommendation recognizes the strong public health benefit of our Dengue vaccine and should help us secure further endemic countries' approvals during 2016.

Lastly, we continue to drive innovation. The first quarter has been busy with R&D news flow, notably with important announcement of positive top line results from two phase three trials with Dupilumab in atopic dermatitis. And for Sarilumab, we reported top line results of a phase three monotherapy study demonstrating superiority versus Humira in rheumatoid arthritis. In diabetes, we submitted LixiLan, a once-daily combination of insulin glargine and lixisenatide to the European Regulatory Agency for review.

Moving on to Slide Number 6, group sales, which include animal health grew slightly in the first quarter and reached €8.543 billion. Changes in vaccine sales reporting and Venezuela currency impact masked the good underlying performance. At first glance, it may appear that reported sales were a bit below consensus forecasts. In fact, approximately half of this gap is due to a reporting change in vaccines, switching €83 million of VaxServe or VaxServe sales, to other revenues. The remainder is due to Venezuela. And although we flagged it prior to the results, it was likely not fully forecast by analysts, excluding Venezuela and VaxServe's group sales, up 3% at constant exchange rate reflecting again the strength of the underlying business. On the bottom line, business EPS grew 5.3% at CER to €1.34. On a reported basis, business EPS was up 1.5%, reflecting a negative currency impact of $0.05

Now on Slide 7, as you know we have restructured the Group into five global business units with effect from January 1st, of this year. This internal reporting structure simplifies Sanofi, deepens specialization and allows clear focus on growth drivers. You can see from this slide that the key drivers of sales growth in Q1 were our Sanofi Genzyme, Sanofi Pasteur, and Merial GBUs. We'll comment on the performance of each of our key franchises in just a minute, but I would particularly like to highlight here the roughly 20% growth achieved by Sanofi Genzyme.

On the next slide, Slide 8, we present sales by global franchise. As you saw from the previous slides, this is not how we manage the businesses. Indeed, all emerging market pharmaceutical sales are now included in the General Medicine and emerging market GBU. However, at this stage, we think that showing you the performance by franchise provides a bridge to our previous reporting methodology and allows straightforward peer comparisons.

Again, this slide emphasizes the importance of our specialty care vaccine and animal health franchise to our growth in the quarter. We are especially pleased that our specialty care business continues to deliver strong double-digit growth, and that our vaccine business grew by 8% despite the Pentacel supply constraint in the U.S., which impacted our developed market performance.

You can see on this slide that Venezuela impacted our overall performance. This is particularly noticeable for consumer healthcare, which was down 9.9% at CER in emerging market, but actually grew 3.8% if we exclude Venezuela. And there is a similar story for established products in emerging market, which were about 2.1% in the quarter but increased 8.8% excluding Venezuela. As a final word on this slide, the established products in developed markets were heavily impacted by Plavix generics in Japan, the impact of which we start to annualize in second half.

Turning to Slide 9 and taking a closer look at the growth drivers in the individual franchises, you can see that the success story of our rare disease business has continued in the first quarter. Sales of the global franchise were €646 million, up 8.5%. New patient accruals continued to be the main contributor to the growth of our brand in Gaucher, Favry, and Pompe diseases.

Specifically in Gaucher, the first quarter marked a milestone, with now more than 500 patients receiving Cerdelga, of which 38% are from non-Cerezyme patient segments. New patient accruals also translated into growth for Fabrazyme in the quarter, growing 6.4% in the first three months following a particularly strong fourth quarter last year.

On Slide 10, our multiple sclerosis franchise delivered very strong growth in the first quarter. Sales of our two brands grew significantly compared to the first quarter of last year. Aubagio remains the fastest-growing oral disease-modifying therapy in the MS market, and annualized sales now exceed €1 billion. And particularly traced to serious success of Lemtrada, it's reported by new clinical evidence that continues to demonstrate how this highly effective drug can serve as a transformative treatment for appropriate patients.

Moving on Slide 11, our global vaccines business unit continues to deliver. Vaccines showed good growth of 8.2% despite lower sales of Patacel due to supply constraint in the U.S. that we highlighted last quarter. Sales in the quarter were driven by the polio, pertussis, and Hib vaccines franchise in emerging markets, and by Menactra in the U.S. as a result of favorable order phasing by the CDC.

In addition, Dengvaxia contributed to growth in emerging markets with an initial €19 million recorded from sales in the Philippines. Of note, we recently submitted a dossier for approval of Dengvaxia to the regulatory agency in Europe.

Now on Slide 12, let me turn to our diabetes franchise and have a closer look at the performance of our two insulin glargine products, Toujeo and Lantus. My main message here is that our global diabetes franchise continues to perform in line with our revised guidance from last October. In the first quarter, worldwide sales of diabetes were €1.7 billion, down 4.5%, which is actually better than the 12.6% decline we saw in the previous quarter. As expected, first quarter sales in the U.S. continued to be negatively impacted by lower average net price. Indeed, this resulted in a sales decrease of 11.1%. However, from a volume perspective, I would also like to point out that our combined glargine franchise of Lantus and Toujeo maintained a relatively stable share of the basal insulin market in the U.S. In Europe, diabetes grew 4% despite biosimilar competition. And in emerging markets, sales increased by 12%, excluding Venezuela, with strong contribution coming from our leading position in the fast-growing diabetes market in China. Overall, diabetes performed in line with our guidance of global sales to be down by minus 4% to minus 8% annually over the period of 2015 to 2018.

Moving to Slide 13, let me take a few minutes to update you on the launch of Praluent and add some perspective. Sales in the first quarter were €12 million, reflecting the significant payer restrictions limiting the uptake of this innovative medicine.

As we know from our market research conducted in the U.S. and Germany, physicians warn us of the PCSK9 class, and their willingness to use this new treatment option have reached already very high levels. However, despite the observed strong intent to prescribe PSCK9 to appropriate patients, both physicians and patients are confronted with significant administrative hurdles which are imposed by payers before providing access to this important new therapy. And prescription volumes remained subdued in key markets, and treatment with this innovative medicine often remains reserved to very severe patients.

In this market environment, we believe our ODDSEY cardiovascular outcome study will be a key driver in shaping the future success of Praluent. The total of 18,000 patients have been enrolled globally in the phase three trial. We are pleased to report that the Data Monitoring Committee of the ODYSSEY OUTCOME study recently completed the first interim analysis. In addition to the review of the safety data, the DMC performed a futility assessment and recommended the study to continue with no challenges. Please note that Sanofi remains blinded to the data from this trial. The second interim data analysis for futility and overwhelming efficacy may potentially be enabled in the second half of this year when 75% of the targeted number of coronary events has occurred.

While we believe that the OUTCOME study results and their incorporation into clinical practice guidelines will support broader use of Praluent, we see limited uptake in the marketplace for the time being. As I mentioned earlier, we are also working with payers and physicians on ways to make it easier for appropriate patients to have access to Praluent and benefit from this innovative medicine. Let me say that we are concerned that eligible patients are not getting timely access to this innovative drug and this concern is supported by feedback we receive every day from GPs and cardiologists as well as from our own market research, which we can discuss in the Q&A.

In the U.S., our efforts also focus on driving product awareness and adoption. Our sales force recently received new promotional material which succinctly communicates the benefits of our dosing flexibility, educate on our efficacy, safety, and administration data and provide information regarding our coverage, patient assistance programs and support services. To expand our dosing flexibility options, we also expect to file the 300 milligram monthly dosing for Praluent with the FDA in the second quarter this year.

Finally, Sanofi and Regeneron strongly disagree with the recent U.S. jury-backed verdict in ongoing patent litigation and will appeal. We do not believe that Amgen's patents are valid, and we are confident that the law and the facts support our invalidative position.

Turning to Slide 14, the consumer healthcare franchise delivered solid performance in the first quarter, with sales up 4.1% -- the impact of Venezuela and adjusting for the divestment of several small products. In the U.S., sales were up 7.7%, driven by our strong Allegra, Nasacort, and Gold Bond brands. In Europe, sales were down 7.3% to €242 million in the quarter, impacted by Doliprane price cuts in France in 2015 and a mild winter season compared with the first quarter of last year.

In emerging markets, sales were down 9.9% to 311 million primarily due to Venezuela. However, excluding Venezuela, CHC sales in emerging markets were up 3.8%. As I mentioned earlier, our exclusive discussion with Boehringer Ingelheim on the intended asset swap of our animal health business with Boehringer Ingelheim's CHCC business are progressing well, and we expect to sign the transaction around mid-year and to close the deal by year-end.

On Slide 15, taking a closer look at the breakdown of sales by geography, you can see that we are well diversified, and that the growth contribution from emerging markets remains strong. Excluding Venezuela, our emerging market growth reached 13.1%, which we believe to be well ahead of our peers. Despite economic slowdown and volatility in some countries, sales in our strongest region, Asia, grew 15.6%.

Sales in Asia were particularly boosted by 17.6% growth in China, where Sanofi outpaces market growth. In China, we continue to benefit from a well-suited portfolio of quality brands in chronic diseases and vaccines. We are also capturing market share for our key brands in the fast-growing county market outside the key cities.

Moving on to Slide Number 16, I want to highlight the key pipeline news and data points which we expect this year. As you can see, 2016 will continue to be rich in R&D news flow. As mentioned earlier, we foresee additional regulatory approvals for Dengvaxia throughout the year. In diabetes, we expect U.S. regulatory decisions on Lixisenatide and LixiLan in July and August 2016 respectively, with an FDA Advisory Committee meeting scheduled for these two products on May 25th. For Sarilumab, the FDA accepted for review our VLA for rheumatoid arthritis, and the PDUFA date is set for October 30th. We are also expecting to submit regulatory filing for Sarilumab in Europe in Q3 2016.

Following the recent positive top line results from two phase three Dupilumab studies in atopic dermatitis, we are looking forward to the expected U.S. regulatory submission for this breakthrough innovation in Q3 this year. And as I mentioned earlier, we expect the second interim analysis of ODYSSEY OUTCOMES during the second half of the year.

Lastly on this slide, I would particularly like to highlight that we have seven registrational studies expected to start this year, including the PD1 from the Regeneron-IO collaboration. Cutaneous squamous cell carcinoma will be a novel tumor type that is not addressed by other PD-1 inhibitors.

As we announced last March, Yong-Jun Liu has joined Sanofi as Head of Research, global R&D. He will report to Elias Zerhouni, President, Global R&D. Dr. Liu is one of the world's most prolific researchers in immunology. He's at the root of the development of several key drug targets in the area of allergy, immunology, and oncology. I have great confidence that Yong-Jun will position Sanofi on the leading edge of scientific breakthroughs and drug discovery in the years to come. The next two slides focus on Sarilumab and Dupilumab. Each has been developed in partnership with Regeneron and we expect these to become the cornerstones of an important new franchise in immunology.

On Slide 17, Sarilumab is the first human IL-6 receptor antibody to be specifically developed in a convenient subcutaneous formulation. We expect the drug to enter the large but highly competitive RA market. The important point to note here is that this is an indication where the unmet needs remain surprisingly high. Many patients cycled from multiple therapies as each drug tends to stop working within a few years.

Physical data for Sarilumab in combination with Methotrexate supports its use in TNF inadequate responders and Methotrexate-inadequate responders, as well as its use as a potential monotherapy. Importantly, X-ray data demonstrating 90% inhibition of structural damage with our 200 milligram dose every two weeks could be a key differentiating point. We also recently announced top line results for the SARIL-RA-MONARCH monotherapy study demonstrating the superiority of Sarilumab efficacy versus Humira in patients with active RA.

The unique profile of Sarilumab also features potential dosing flexibility with two doses 150 milligrams and 200 milligrams every two weeks, which have been [indiscernible]. The U.S. regulatory decision for Sarilumab is expected in early Q4 2016, and the regulatory submission into EU is planned for the third quarter.

Turning to Slide 18, Dupilumab has the potential to be a truly transformative therapy for a whole range of allergic diseases driven by an over-reactive TH2 pathway. It is the only monoclonal antibody in development with dual inhibition of IL-4 and IL-13 receptors. Dupilumab is expected to be the first in a new class of immunotherapies for moderate to severe atopic dermatitis, a serious chronic inflammatory skin disease marked by widespread rash, itching and associated psycho-social comorbidities. Dupilumab is the first systematic therapy to show positive top line results from two identically designed phase three trials in patient with moderate to severe atopic dermatitis, demonstrating compelling efficacy without evidence of immune-suppressing side effects.

In the two studies, which we call SOLO-1 and SOLO-2, Dupilumab's excellent efficacy was shown across a range of endpoints, including the five-point Investigator's Global Assessment Scale, as well as the Eczema Area Severity Index and other measures. More detailed results from SOLO-1 and SOLO-2 will be submitted for presentation at a future medical congress. We are looking forward to the planned U.S. regulatory submission for this breakthrough innovation in Q3 this year. The rolling VLA submission will also include data from the planned second quarter 2016 interim analysis of the LIBERTY CHRONOS study of Dupilumab in combination with topical corticosteroids. Final results for the LIBERTY CHRONOS study are expected in the third quarter this year.

Lastly, we also initiated a European Dupilumab pivotal study in Q1 2016 to assess efficacy in adult patients with atopic dermatitis who respond inadequately to systemic cyclosporine A, or are not suitable for cyclosporine A treatment.

And with that, I will now turn the call over to Jerome to discuss the details of our financial results.

Jerome Contamine

Thank you very much, Olivier, and good morning, good afternoon to everyone. So, I'll start with Slide 20. So, as Olivier mentioned earlier, we experienced a modest ForEx headwind in the first quarter of 2016, which contrasts with the strong FX tailwind in all quarters of 2015. The FX headwind in the first quarter decreased sales by €228 billion, representing a negative 2.6% impact. This was mainly driven by the adverse evolution of several emerging market currencies, which more than offset the modest positive effect from the U.S. dollar against the euro.

The FX headwind impact on the EPS of $0.05 per share, or 3.8 percentage points was modestly higher than the impact on group sales. However, all these does not include the Venezuela [indiscernible] Olivier's already alluded to in the introduction of this call. So, specifically on Venezuela, there are two impacts. First, we now use a new FX rate to translate our Venezuelan sales into our accounts, which led to a decline in sales of €197 million. On this total, 52 were CHCC, and the bulk of the rest was other pharma products.

Looking to the rest of the year, we will experience another difficult sales comparison in Q2, but an easier comparison in the second half. Specifically last year, we recorded €199 million of sales in Q2 in Venezuela, 24 in Q3 and 32 in Q4. I'll also remind you that we booked FX losses related to Venezuela in Q3 and Q4 last year, which clearly are not going to occur this year. As a matter of fact, we also booked in this quarter of '16, this quarter, 102 million FX loss in other operating income to reflect our remaining exposure to Venezuela in line with what we mentioned during our full year results call. Overall, this exceptional negative impact of Venezuela on business EPS in the quarter was $0.09. As always, for additional information and for exchange [indiscernible] sensitivities to key currencies, please refer to the first slide of finance appendixes of this slide deck.

Now, let's have a closer look at the first quarter P&L on Slide 21. Let me remind you once again that my comments are based on aggregate Group sales, which still include animal health, while under IFRS rule, Merial is treated as discontinued operations as of January 1, 2015. As Olivier mentioned earlier, aggregate Group sales in the quarter were around €8.5 billion, a slight increase of 0.7% at constant exchange rate. As a reminder, other revenues now include VaxServe sales of vaccines from third-party manufacturers to clarify. These related amounts were €100 million in Q1 2015, as you can see in this slide, on €83 million this quarter.

Gross profit was €6 billion in the period, up 0.6% at constant exchange rate. I will come back to the details of the gross margin and OpEx on the following slides, but let me highlight here the lower than anticipated increase in SG&A, up 1.3%, reflecting tight G&A cost controls in the period on reallocation of resources behind key product launches, including Praluent, Dengvaxia, Toujeo, Sarilumab, and the MS franchise.

Other current operating income was positive, €79 million in the quarter compared to negative €67 million during the same period of last year. In the first quarter 2016, this line included an indemnity amount of €192 million before tax pursuant to a final arbitration which was granted to Sanofi in February as consequence of a contractual dispute. Partially offsetting these gains was a foreign exchange loss related to Venezuela which I described already.

Moving on to the next item, the share of profits from associates was €23 million in the first quarter compared to €31 million in the same period in 2015. This line includes Sanofi's profit share from our equity stake of 22% in Regeneron and in the vaccine joint venture of Sanofi Pasteur with Merck in Europe, which, as you know, is targeted to be dissolved by the end of 2016. Also, the initial cost of our diabetes collaboration with Verily, formerly known as Google Life Sciences, was recorded in this line in the first quarter of 2016. Business operating income of €2.4 billion was up 3% at constant exchange rates.

I move now to Slide 22, reviewing the items below the BOI. Net financial expenses were modestly higher as compared to the same period of last year, which includes small capital gains linked to the sale of some financial investments again in Q1 2015. The effective tax rate, including animal health in the first quarter was 24%. For the full year of 2016, we continue to expect the tax rate to be between 24% and 25%. Business net income in the first quarter of 2016 was €1.7 billion, up 3.5% at constant exchange rates. Excluding the indemnity amount of Venezuelan foreign exchange loss, the business net income would have increased by 1.5% at CER. As mentioned earlier, business earning per share of €1.34 in the first quarter was up 5.3% on 1.5% on a constant exchange rate on a reported basis is practical. As a result of share buyback, the average number of shares outstanding decrease in the first quarter of 2016 by approximately 20 million versus last year.

Turning to Slide 23, let's look at the evolution of our gross margin. Adjusting the historical value for the recertification of VaxServe, we saw a very slight uplift in the gross margin ratio in the first quarter of 2016 to 70.3%, representing an increase of 0.2% versus the first quarter of last year. This outcome reflected a number of moving parts which largely counter balanced. On the positive side, we had higher sales of Sanofi Genzyme on vaccines, some further cost efficiency measures, as well a small foreign exchange rate benefit. On the negative side, we had the impact of lower average net price for Lantus in the U.S., increased investments in monoclonal antibody production, generic erosion of product sales in Japan, and the recall of [indiscernible]. On the full year basis, considering the recent declassification of VaxServe sales from [indiscernible] sale to other revenues, and in light of our good Q1 performance, we now expect our 2016 gross margin ratio to be above 69%, but somewhat below 70% at constant exchange rate.

Turning now to the evolution of operating expenses on Slide 24, OpEx was €3.7 billion, up 3% at constant exchange rate in the first quarter. First quarter R&D expenses of €1.3 billion were up 6.5% at constant exchange rate, reflecting our new collaborations in immuno oncology and diabetes, Dupilumab phase three program, and Praluent ODYSSEY [indiscernible] study, as well as post marketing studies with newly launched products. This resulted in a higher R&D to group sales ratio of 15% in the first quarter of 2016 compared to the same period last year. SG&A expenses were €2.4 billion, reflecting an increase of 1.3% at CER. As I highlighted already, this modest increase reflects tight G&A cost controls in the period and reallocation of resources behind key product launches. In the first quarter of 2016, the ratio of SG&A to group sales increased 0.3 percentage points to 28.3% compared with the previous year. For the remainder of 2016, we should continue to see savings on SG&A, resulting from prioritization on the gradual impact from the implementation of our new organization, partially offsetting key product launches launch expenses. Overall, we continue to expect OpEx in 2016 altogether to grow at a similar rate versus 2015, again at constant exchange rates.

Moving on to Slide 25, you can see that our net debt has increased to almost €8.4 billion in the first quarter of 2016. This increase in part reflected significantly higher share buyback activity, which I will mention in a moment. Free cash flow was €878 million for the period, with capital expenditures of €325 million versus €355 million in the same period last year. The operating free cash flow of 2 billion was slightly above the level of last year. Now, working capital requirements increased over Q1 2015, as a result of trade working capital seasonality mostly related to vaccines and animal health businesses, and higher non trade working capital related to payments of taxes, of rebates which occurred in Q1 2016. This has to be looked in conjunction with the very favorable working capital we achieved during the last quarter of 2015. Given general financial market quickness in the beginning of 2016, we intensified our buyback activity and repurchased over €1.4 billion of our own shares. As a result, the average number of shares outstanding declined by 20 million, or around 1.5% in the first quarter of 2016 compared to the same period last year. Lastly, we also recorded €569 million of acquisitions, licensing, net of disposals, mainly related to the upfront payment in connection with the licensing agreement with Hanmi Pharmaceuticals in diabetes.

Moving to my last slide, Slide 26, let me conclude by reiterating our outlook for 2016. 2016 business EPS is expected to be broadly stable versus 2015 at constant average exchanges rates, barring major unforeseen events. When applying [indiscernible] 2016 average exchange rate, the remaining quarters of the year for this full year of 2016 guidance, the impact for ForEx on business EPS is expected to be slightly negative, around minus 3%. As we discussed in our 2015 full year results call in February, we continue to expect several headwinds for the remaining quarters, quite a few tailwinds, we'd have a positive impact during the second half of the year. In the interest of time, I would not go into more detail, but you can find more details in the appendix of this presentation.

I will now turn the call over to Olivier for his conclusion.

Olivier Brandicourt

Thank you, Jerome. So, to conclude, on Slide 28 you can see that we delivered solid financial results in the first quarter, which we are pleased about given the headwinds we faced. At the same time, we are diligently working on our strategic priorities around reshaping the portfolio, executing our key product launches and driving innovation for future growth. Overall, this first quarter gives us further confidence that we are progressing well on our roadmap.

Now, before we open the call to Q&A, I'd like to announce that, after 30 quarters as head of our Global IR function and a member of the senior management team, Sebastien Martel has decided to take on another exciting opportunity within Sanofi Genzyme in the U.S. Sebastien will be responsible for strategy for specialty care GBU.

George Grofik, who has led our U.S. IR operations for the last five years, and whom many of you will already know, is relocating to France and will now lead the global IR team. I would like to thank Sebastien for his contribution over the last seven years, during which Sanofi has won many IR awards, and wish him all the best in his new leadership role. I would also like to welcome George to his new function.

So, with that, Sebastien, I think we need to move to the Q&A.

Sebastien Martel

Thank you, Olivier. Yes, we're ready now to open the call to your questions. As a reminder, we'd like to ask you to limit your questions to a maximum of two each, and also, as Olivier said earlier, to respect the sensitivity around the mitigation proposal. We'd like to ask participants on the call to keep questions limited to those pertaining to the first quarter results.

And with that, Operator, we're ready to go.

Question-and-Answer Session

Operator

[Operator instructions] Our first question is from Florent Cespedes from Societe Generale. Please go ahead.

Florent Cespedes

Two quick questions, first, on the consumer division, could you tell us if you could further reinforce these divisions through another large acquisition? And my second question is on the insulin Lispro. Could you remind us our strategy with this product in the U.S., and potentially outside the U.S. as well? Thank you very much.

Olivier Brandicourt

Thank you, Florent. So, on -- so if we never say no, right, so on the first question, but we're very busy already doing this swap, and increasing our franchise by the very significant level. So, for now, that's what we are focused and concentrated on, and we really want to be successful in establishing and then growing this new or strengthened franchise. But, as we said during the last year or so, we would -- because it is a very fragmented sector and industry, we would look for opportunities around specific assets when they present.

For the second question, I'm going to ask Pascale to give you the answer.

Pascale Witz

Thank you, Olivier. So, Florent, regarding the strategy for Lispro, just be aware that actually the central strategy for Sanofi to develop an integrated portfolio of products that can address the different needs of patients at different stages in their treatment journey. So, we want to be able to offer a wide range of products. And so, by bringing to market Sanofi's own insulin, Lispro, would further to reinforce our commitment to expanding the access to medication for diabetes patients. So, we will commercialize this product in geographies where we can achieve this objective, and it would be a bit too premature to go into more details at this stage.

Olivier Brandicourt

Okay, thank you. Thank you, Pascale.

Florent Cespedes

Thank you.

Sebastien Martel

Next question, please?

Operator

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

Jo Walton

Hello, Jo Walton. Firstly, can we thank Sebastien Martel for all his unique input to all of our work over the past 30 quarters? And for some of us who knew him in his role at Serono as well, he's been in IR quite a fixture in our setting for a long time. We wish you well in an operational role.

And on to my questions, if I could please ask about any impact in Japan from biosimilars for Lantus, that was something that was called out by Novo in their call. Your Animal Health business is doing extremely well. I guess that the BII consumer business may not be doing quite as well. Is there any opportunity to adjust the price to reflect the extreme strength in your animal health business? Can you also give us a little bit more input on China? You've done extremely well here. Other companies are telling us that the bidding process that's going to materialize in China may hurt their results more towards the second half of the year. So, just a question of whether you think that the strength that we're seeing in your China sales is sustainable. And a final one on your view on LixiLan and Zoltifi, the relative positioning of those given that we've had such strong data from Leader, whether that's made a difference, because Victoza seems to be now a much stronger competitor for Lyxumia. And I apologize. I am going to try with one final thing, although I'm sure other people will ask this, as well. With Praluent, you've talked about your market positioning and your market share your market research. I wonder if you could tell us a little bit more about that.

Olivier Brandicourt

Well, Jo, we are accepting all those questions because you were so nice, right, to Sebastien. So, thank you very much for your comments. But, all right. Pascale, will you give you the answer on Japan Lantus first? Do you want to start?

Pascale Witz

Yes, sure. So, Jo, I think you certainly know in Japan, the biosimilar launched before actually, way before our new insulin glargine, Lantus XR, so it launched at a significantly [indiscernible] without the two weeks prescription. Now, you also remember that the Japan market is the smallest of our three mature markets which we have. So, at this stage, we have launched last September our Lantus XR, which is gradually penetrating the market, but it is still under the two weeks limitation at this stage. Do you want me to take Lyxumia?

Olivier Brandicourt

Well, you can come back and say it. That's fine. Carsten on the call, please, question on the performance for the quarter of Animal Health?

Carsten Hellmann

Yes. We are doing well. We had a change of the structure of distribution in the U.S., so there is some front load in the Q1 result. But, we are having a good strong momentum, and we will manage to double-digit growth for 2016. About the question of the price adjustment, I will give that to you, Jerome Contamine.

Jerome Contamine

I don't think there is any comment we can make on that. I think at this stage, we are in an exclusive negotiation, as you know, with Boehringer. I don't think we can comment more.

Olivier Brandicourt

Yes. No, I agree with that. Jo, we are planning to sign by midyear, end of June or beginning of July. And at this point, we won't be able to give you an answer on that specific question. China sustainability, Peter?

Peter Guenter

Yes. So, of course in general terms, we are very happy with our first quarter in emerging markets, 30.1, actually very homogeneous. If you take out Venezuela, it affect Latin America 11%, Asia 15.6%, Africa, Middle East, South Asia 11.8%, and Eurasia 10%. Now, specifically on China, so yes, we're having a very good performance again in the first quarter. We have already discussed last call on the reasons for that good performance, if there's a mixture, actually, of the right portfolio, the right structure, a very performing team also in the counties. Now, what the future will bring is probably not every quarter will look like that, and it's true that we are going through those provincial tenders, that there will be further hospital second bids. So, but it's a little bit difficult to predict now. The only thing I can say is that, if you look a little bit further down the road, that IMS projects a growth, a CAGR between now and the end of the decade of 7%. So, that is more or less in line with the last couple of quarters. So, if we stick with that forecast, it would mean that we would probably be in some kind of steady state for what the market concerns for China.

Olivier Brandicourt

All right, thank you very much, Peter. Lyxumia positioning, Pascale?

Pascale Witz

Yes, okay. So, Jo, coming back first to the comment I made earlier, which is our strategy to develop an integrated portfolio of product that can address the different needs of the patient throughout their journey, so within this strategy, LixiLan is really well positioned, because it can offer and it can be positioned as the first injectable that provides greater HB1C control for patients initiating a basal therapy, but also in [indiscernible]. And actually, it is important to keep in mind that actually LixiLan would offer the two components of the systemic addressing the two type of glycemic effects, such as the fasting plasma glucose and post prandial glucose. And by doing so, I mean, this offers more choices for the conditions [indiscernible]. Now, regarding your questions on the studies that have been conducted, I mean, we cannot really comment on the study, the leader study, because the full results have not yet been presented. However, I would highlight that this study has been conducted in a study population that was different from the populations studied with ELIXA. And I also would like to remind you that, with LixiLan, we also are very confident in the quality of the data submitted since we evaluated the safety and efficacy of LixiLan. And you remember that it included the outcomes of the ELIXA cardiovascular outcome trial, which ensure the cardiovascular safety. And the other side of the equation is Lantus, with the ORIGIN study, which has long-lasting and a very large patient population that's demonstrated the cardiovascular safety.

Olivier Brandicourt

Okay. Jo, on Praluent and the market research we've done, we've done that with 100 specialists and 100 primary care physician in the U.S., and to just survey their attitude towards PCSK9 in general. And I must say the survey is completely in line. Those results are completely in line with our own concerns that [additional patients are not getting access to the drug, or not enough. And the three primary issues they raised are around 80% of cardiologists and PCP felt that payer requirements created a very heavy burden for them and their office staff. About two-thirds of those physicians felt that they can't put every patient with medical needs under PCSK9 in a timely manner. So, it's a question of timing due to the payer requirements. And they concluded that, for two-third of them, that they felt they were facing a higher level of hurdle, and therefore frustration, with the payer restriction compared to other cardiovascular treatments and medicines. So, we did that last week, and we felt, again, that was a good illustration for what I was saying earlier.

So, next question, please?

Operator

The next question is from Tim Rice from Deutsche Bank. Please go ahead.

Tim Rice

Hi there, guys. I'll only ask two questions. So, if we look at the guidance that you set in the full year, were the Venezuela declines in sales, or the indemnity amount that you mentioned, were either of those included in your guidance when you set outlook for the full year?

And then, secondly, just looking at the basal insulin market predominantly in the U.S., we've now have to see the launched [indiscernible] Toujeo, as well. We're seeing interesting trends with Tresiba in terms of the dosing that's actually getting taken up. Can you just talk about which patients Toujeo's capturing, which patients Tresiba's capturing, and if you see a difference that's going to last in the longer-term? Thank you.

Olivier Brandicourt

All right. Thank you, Tim. Jerome, I think...

Jerome Contamine

So, Tim, on the guidance, I mean, as you know, I mean, the level of a large company have always set a number of headwinds, or a certain number of tailwinds, and [indiscernible] from the pool. Now, our guidance includes all what you refer to, i.e. the negative impact of Venezuela, as well as the contribution from this positive outcome from this penetration. I mean, knowing that we are still in end of April, so, I mean, lot of things can happen on both sides, but -- not on these ones, but on the other things. So, to make my answer short, our guidance is confirmed, taking these two elements into account.

Olivier Brandicourt

Okay, Tresiba...

Pascale Witz

…On Toujeo, Tim, on your question on the basal insulin in the U.S., I mean, Toujeo is for us the best product to serve a wide range of patients. And its benefits are not limited to any type of patients, not the high-volume patients or other type of patients. Remind you that its profile with a flat PT-PD curve and prolonged effect actually serves all type of patients. And I would add to that that actually we continue seeing the ramp-up of Toujeo with a market share of 4.4% in the U.S. in the first quarter, which is 1.3 points over the fourth quarter of last year. And I would also highlight that actually we continue to see a very nice increase of the prescription of Toujeo in the first quarter in the U.S.

Sebastien Martel

Thank you. Next question, please?

Operator

The next question is from Michael Leuchten from Barclays. Please go ahead.

Michael Leuchten

Thank you. Two questions as well, please. One, on trial and probably for Elias, the interim that was just performed was on the back of, I believe, 50% of required events, and you're expecting the second interim in the second half of this year. Just mathematically, can you actually get to 75% of the required events if you just had 50%, given the patient flow?

And then, the second question on -- around the diabetes franchise, if I look at the Lantus U.S. revenues Q1 sequentially over Q4, the decline seems to be less severe than maybe it could have been coming out of Q4. So, is it actually recovering or moderating quicker, or is it just a shift between the quarters and I shouldn't read too much into that? Thank you.

Olivier Brandicourt

All right, very good. Elias?

Elias Zerhouni

So, for the first question, it's pretty straightforward. As, when we get 50% of the events, you have to adjudicate them, and takes a while between the time you get effective 50% and the time you analyze it for futility. And therefore, we just did the analysis, but we're way beyond 50% now. And so, I'm confident we can recruit what we need by the second half, or we can complete the event rates that we're expecting by the second half of this year.

Olivier Brandicourt

All right. On the second question, yes, we have a minus 4.5% sales decline in Q1, which is actually minus 3.6% if you take Venezuela out. And to your point, it's significantly less than the 12.6% negative we've seen in Q4. But, in Q4, and you may remember, it was mainly driven by higher commercial rebates, also an unfavorable channel mix towards government channels. We also faced delayed medical bills for Lantus, and we had a basis which was unfavorable for comparison because we had the Lantus price increase during the last quarter of 2014, and exactly in November. So, for all those reasons, it's much more favorable in Q1, which reflect, of course, an expected what we had expected, a lower average net price versus last year, which is basically due and driven by two third by unfavorable channel mix, and one third by copay assistance, and additional rebates. But, we are reassured by our Q1 diabetes performance, because it is right in our guidance.

Michael Leuchten

Thank you.

Sebastien Martel

Next question, please?

Operator

The next question is from Philippe Lanone from Natixis. Please go ahead.

Philippe Lanone

So, gentlemen, two questions also. First, on Praluent, Amgen mentioned that 77% of scripts were rejected at pharmacy, but apparently not abandoned. So, it is just a timing issue, and in next quarters we'll have sales getting up, or do we have to wait for the [indiscernible] study to really see the product pick up, in your view? And second question is on vaccine you are splitting with Merck. You indicated you want to change strategy. Could you elaborate what kind of strategic changes you expect to implement there and what kind of positive effect you await from that?

Olivier Brandicourt

Okay, very good. Thank you. Pascale, Praluent?

Pascale Witz

Yes. First with Praluent, Philippe, we do continue to see a limited uptake, and I think Olivier mentioned already that we see some precedented payer restrictions. Olivier explained some of the survey that we are getting with the feedback, which really are aligned with our own concerns that the eligible patients are not getting access to this very innovative drug. Now, we are working with the payers and with the physicians to help work through these barriers. We probably have to recognize that this is a new era of measuring product launches, and that's having launched before the cardiovascular to come the fact we did not give the physicians and the payers all the elements that they usually need to demonstrate the broader use, and to incorporate that in their clinical practice guideline. So, we should see a gradual uptake. We do see some more confidence, some growing confidence from our physicians in managing the filling of the different forms so that they get the coverage for their patients. But, however, this is actually a different context for the cardiologist and the primary care physician, and therefore we've seen that this is going to be lifted as we go, and we will see some very gradual uptake.

Olivier Brandicourt

Okay, thank you very much. Vaccine?

Unidentified Company Representative

With regard to vaccine, thank you for your questions, Philippe. The decision to unwind the joint venture is a strategic decision. And we realize that with Merck, we compete more and more by [indiscernible] and type B. We realize also that we have different priorities in terms of supporting R&D in vaccine. But, the objective we have is really to unlock value around combination vaccine where we think there are still some potential. And also on flu, where it's obvious that, in the last few years, the investment has been relatively minimal. If we look at it from a long-term perspective, the unwinding of the joint venture will allow us to leverage our portfolio, and more precisely as if that had not been approved by Merck for development. So, basically, we see an opportunity to better resource and allocate our resources behind our brand where we continue to see strong potential.

Olivier Brandicourt

Thank you very much.

Philippe Lanone

Thank you.

Sebastien Martel

Next question, please?

Operator

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

Steve Scala

Thank you. I have a couple questions. The first is a follow up to an earlier question. But, in previous presentations, you have said that the interim analysis for ODYSSEY OUTCOMES was expected in the second half of this year. Today you have substituted the word potentially, instead of expected in your slides. So, I'm wondering why the language has changed. Does it have something to do with what was seen at the first interim?

And the second question is Regeneron has said that, for the trial to stop at the interim, secondary endpoints must be hit. I'm not aware that Sanofi has said this. So, would you confirm the accuracy of that statement and how many interims would need to be hit for the trial -- how many secondary endpoints would need to be hit to stop the trial at the interim? Thank you.

Elias Zerhouni

Yes. Thank you, Steve. Let me be clear, when you try to time an analysis in a event rate trial, it's always uncertain, because adjudication takes time, and you really have to recall every patient to make sure that you have quality data. So, that's always a potential. We're still hopeful that we will be able to do it within the timeline we described. And obviously we need to provide the Oversight Committee clean data. So, that's the word "potential," because I don't know if it's going to be one month late, one month earlier. I have no idea. And no one can really be sure about the date because we're dependent on that.

The second question is -- it's correct. I think that there is -- when you look at overwhelming efficacy, the word overwhelming can actually include secondary endpoints in the mind of the DSMB. So, I think generally the practice is not to look at just the primary endpoint, but to look at the balance of primary and secondary, and even look at the components that they may send back. So, we've not said that. We didn't think it was important to really be that specific, but it's correct. You need to really look at the balance of the evidence, not just one index.

Olivier Brandicourt

Thank you, Elias.

Sebastien Martel

Thank you, Steve. Next question, please?

Operator

And next question is from Peter Verdult from Citi. Please go ahead.

Peter Verdult

Just two topics, firstly Dengvaxia and then on diabetes. And I realize 90 million, great start, launched only in the Philippines, rolling out in emerging markets, just wanted to get an update on your expectations for Dengvaxia this year. I think previously you've talked about 200 million. It seems that that could be, shall we say, conservative. So, anything you could discuss about the outlook for Dengvaxia.

And then, just moving on to diabetes, on one hand the long-term outlook's improved with the deals that you've done with Lexicon and Hanmi, and you've put out the guidance back in Q4 about minus 4% to minus 8% declines for the diabetes franchise. But, I want to clarify, Pascale, that everything you've been saying on the call, despite Nova coming out with CD benefits for their GLP-1 portfolio and the hyper-benefit for Tresiba over Lantus. Are you basically saying that that's not changed your outlook for diabetes? I just want to clarify that's the case. There are my two questions. Thank you.

Olivier Brandicourt

Thank you very much, Peter. So, Olivier, do you want to answer the first one?

Olivier Charmeil

Peter, thank you for your question. We are happy with the first quarter. That's gone exactly as we were planning. It's the first [indiscernible] immunization product starting in the Philippines. We are also very happy with the recommendations that have come from the sales working group, that as recommended in endemic countries the use of Dengvaxia, given the public health impact in terms of decreasing the burden of the disease. We consider that, of course, it will contribute to the rollout of immunization to be campaign in the upcoming months. As we speak, we know that the Dengvaxia has been [indiscernible], at the end of 2015, more than 20 countries. We are expecting to be in a position to have in 35 countries by the end of the year, so an incremental 15 countries. And we think that we will meet [indiscernible] in the upcoming quarters. Of course, it's difficult to be more precise, as the immunization program to start at a precise date. One of our next important milestones is doing to be Brazil. Brazil has moved very rapidly, and we've got the licensure from NVISA in almost a recall manner. The process is moving ahead, and the next important milestone for us in Brazil is going to be the discussion on price, and we are going to have discussion with CIMET and we are expecting to get some new NVISA upcoming weeks.

Olivier Brandicourt

All right, thank you very much, Olivier. Pascale, [year-end] guidance?

Pascale Witz

Yes. So, Peter, actually, yes, our Q1 performance, we are satisfied with it, so -- because it is confirming our previously issued guidance. And we confirmed the guidance, so that we have said that we have expressed in October, which was minus 4% to minus 8% over the period of 2015 to 2018.

Olivier Brandicourt

[Indiscernible] I just confirmed.

Peter Verdult

Thank you.

Sebastien Martel

Thank you very much, Peter. Next question, please?

Operator

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

Vincent Meunier

The first one is on your buyback policy. Can you give us an update on your intentions during the Medivation process?

And the second question is on your project in Pompe disease. Can you elaborate on the trial design for neoGAA and the sizing of the population, if possible, and also if possible the sizing for the product in terms of sales? Is it more a myosan like opportunity, or a [indiscernible] opportunity?

Olivier Brandicourt

Okay, very good, Vincent. So, do you want to take the share buyback question, Jerome?

Jerome Contamine

Yes, thank you, Olivier. So, good morning, Vincent, or good afternoon. So, as you saw [indiscernible], we bought back up to €1.4 billion the first quarter, which clearly is a [indiscernible] we did in the previous years. I mean, the previous years we did between 1.7 billion and 1.8 billion, and we are sticking to the opportunistic buyback strategy we're having. So, I will not give you a precise guidance on what we are going to do in the coming quarters. The only thing I'd like to highlight is that, I mean, I don't know if you saw that Moody's just issued a release saying that, whatever we do on Medivation, that maintain our rating.

Olivier Brandicourt

Okay. Thank you, Jerome. David, do you want to take the question on neoGAA?

David Meeker

Yes. So, with regard to the trial design, I think the endpoints in this disease are relatively limited in terms of what you can consistently manage. They have to do with ambulation, and they have to do with ability to walk, and they have to do with the respiratory function. I think I would just direct you to the concept of forced vital capacity, which is a very standard way of measuring your lung capacity, and it's the measure that really correlates with clinical outcomes there as opposed to some of the others, like muscle strength, respiratory muscle strength, which has been talked about in other areas. Size of the trial, I don't have the number off the top of my head, but it will be consistent with other trials in rare diseases. And the last part of your question was the positioning of this drug. NeoGAA is an extension of the current myozyme. In other words, it's the myozyme molecule more heavily phosphorylated. And by adding on more phosphate to that molecule, it increases its uptake into the cell. And we know from animal studies that it's about five times more potent in an animal model than the current myozyme. We'll see how that translates in a human setting, because demonstrating that in humans of course is much more challenging. If we move forward and it is approved, we would expect that the neoGAA would actually replace myozyme, so it would not be a Cerezyme Cerdelga, which where Cerdelga is an alternative therapy, this would really just be an improved enzyme replacement therapy that would replace it, and myozyme is currently on a 600 million plus run rate. And there's still lots of room to grow in that overall Pompe rare disease space.

Vincent Meunier

Many thanks.

Sebastien Martel

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

Operator

The next question is from Graham Parry from Bank of America Merrill Lynch. Please go ahead.

Graham Parry

Great. Thanks for taking my questions. So, the first one is just on the PCSK9 litigation, if you can give us your thoughts on next steps and potential timelines. And in terms of both your appeal, request to retrial, the injunction ruling and any potential settlement discussions? And secondly, if you could talk us through recent guideline updates on Praluent, how you think they may change your ability to get a payer access, and how the guidelines may change, again, post outcomes data. And then thirdly, on the Boehringer Ingelheim deal, you're still in negotiations here. So, any reason to believe that any of the terms could look different from what you've announced in December, or is what was in the original press release pretty much set in stone? And if you can help us understand why it takes quite so long to sign the deal, and if there's any risk still that it might not happen. Thank you.

Olivier Brandicourt

Okay. Around PCSK9's litigation, Karen?

Karen Linehan

Sure. Thanks, Olivier. As, the decision in March 16th is only the first step in this litigation. And as Olivier said, we strongly disagree with the outcome of the late jury trial, and we will appeal that decision at the appropriate time. Right now, we're in what is known as the post trial briefing period, which will go until May 25th, at which point the judge will consider all that has been put before her and issue a decision. We don't believe that it will come very quickly. We believe it'll be a couple of months, while in theory she could rule at any time, we firmly believe, given the nature of this trial, that it will take a few months before she ultimately issues something, and at which point we'll be in a position to appeal. And again, we truly believe that the law and facts support our position of invalidity.

Olivier Brandicourt

Very good. Thank you, Karen. Pascale, for the guidelines?

Pascale Witz

Yes, Graham, thanks for your question. As, at the last ACT Congress, we are not yet at the step of a guidelines, but we have a very good first step before the new ACT guideline, which is that the expert consensus decision pass week was renewed, and now considers the PCSK9 inhibitors in patients who are on maximal tolerated statin for secondary prevention as a second step to achieve the ideal reduction in the case of ASCVD, and in addition to ezetimibe, or in place of ezetimibe when the MDN level is more than 190 milligram. So, actually, this decision pathway, by recognizing different patient benefit groups, and by providing guidance and threshold to a healthcare professional to when to begin treatment with our PCSK9 inhibitors, and client find that there are some groups of patients for which you can consider PCSK9 as a choice as an initial non-statin therapy in addition to maximally tolerated statins. I think we will help the healthcare physicians to actually navigate the environment and the choice of therapies. So, this is, as I said before, a first step before new ACT guidelines. And I also would like to highlight that, in Europe we're also expecting new updated ESC guidelines in Q3 of this year.

Olivier Brandicourt

Thank you, Pascale. On the BII deal, well, negotiation progressing well. That's what I can say with BII. You may feel that it's longer because we went through a first phase for [indiscernible] exclusivity, which we are still in, and the deal has -- we're planning to sign the deal by, as I said, mid-year. So because we are in exclusive discussion data exchange with BII at this stage are of course strictly confidential. But, again, what I can say is we are progressing well, and we expect to sign the deal mid-year, and to close the deal by the end of this year. So, no change versus what we have said previously.

Sebastien Martel

Thank you. I think we are going to take the last question.

Operator

The last question is from Seamus Fernandez from Leerink Partners. please go ahead.

Seamus Fernandez

So, just a couple of quick ones, first, just in terms of the commitment that's going to be necessary during the process with Medivation, I know you said that you have flexibility for more business development. But can you just give us in terms of the willingness and the desire to do more business development in potentially other therapeutic areas, is it there, and do you expect to continue to be active in that space?

The second question is just public statements made about interest in rare disease business fields up to $20 billion. Could you just clarify that statement? Is that accurate? I just want to make sure that that statement was accurate as reported.

And lastly, the €12 billion to €14 billion pipeline target across the six major product launches, given the launch trajectory of Praluent is there any change in your expectations for that number, and are any of the products launching better than or worse than expectations? Thanks.

Olivier Brandicourt

Thank you, Seamus. [indiscernible] and the guidance around combined peak sales of the six new launches, we are not changing our long-term view on those and still the €12 billion to €14 billion combined peak sale, so, no change there.

Coming back to our flexibility in BD, what we said I think has been a little bit of confusion, and we did say that we were ready to do bolt-on and to mid-size transaction up to something similar to what we had executed back in 2011, I think, with Sanofi Genzyme, or with Genzyme. So we have not specifically highlighted I think, any specific ETA when we said that, except that we said it would be strategically sound, and therefore it would be either in one of the ETA where we have leadership or in one TA where we are starting, but we would like to strengthen. So, that has, frankly not changed and I guess that's clarify and answer your question.

Okay. And with that, thank you very much, everyone. Thank you for your questions, and we concluding this call. 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 your lines. Good-bye.

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