FEBRUARY 08, 2012 / 1:00PM, SAN.PA - Full Year 2011 Sanofi SA Earnings Conference Call
`
`Elias Zerhouni - Sanofi - President - Global Research & Development
`
`Right, so dengue is different in its pathway of approvals.
`
`Eric Le Berrigaud - Bryan, Garnier & Company - Analyst
`
`So precisely the second question relates to PCSK-9.The target per se looks very much interesting, but what could you say already about safety and
`in terms of injection site reaction, whether you see anything? And whether your own formulation is already into early stage development?
`
`Elias Zerhouni - Sanofi - President - Global Research & Development
`
`No, no, the overall formulation is pretty -- we clearly understand that. We wouldn't be going Phase III in three months if we didn't have that. The
`device is something, the dosing we're pretty clear on what needs to done.
`
`In terms of safety I don't know if you went to AHA, but we did report at the AHA that immunology (inaudible). And we don't see that in the Phase
`II trials.We had one skin reaction, and unclear whether it's the product or something else. So it looks extremely safe from the current data that we
`have.
`
`No increase in other parameters that would say oh, there is a counterbalancing effect or lowering for example in HDL or something like this that
`typically you'd worry about. So right now we are quite comfortable with the safety profile.We'll find out in Phase III.
`
`Eric Le Berrigaud - Bryan, Garnier & Company - Analyst
`
`Okay. Last one in terms of dividend, do you plan as last year to pay too for the possibility for the dividend to be paid in shares?
`
`Jerome Contamine - Sanofi - EVP, CFO
`
`No.
`
`Sebastien Martel - Sanofi - VP - IR
`
`It was a quick one. Maybe we will take questions here from Alexandra Hauber, second row.
`
`Alexandra Hauber - JPMorgan - Analyst
`
`Thank you. I have several questions. Question for Hanspeter first. I think it was said in the press release that this solostar conversion is now up to
`50% up from 40%. Is that going fairly smooth and are you confident you can sort of increase that penetration every year by ten percentage points
`so that by 2014, '15 we should be at this sort of 80%, 90%? And what are you actually doing to make sure that that's happening?
`
`And then second question is just around the topic of pens. Have you finally defined which device you're going to take into the Phase III for the
`lixisenatide combination? Are you still pursuing the version that both components can be titrated? And then also -- I'll save that one later if you
`want to take the questions one by one.
`
`THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us
`
`©2012 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without
`the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated
`companies.
`
`27
`
`Mylan Ex.1064
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`FEBRUARY 08, 2012 / 1:00PM, SAN.PA - Full Year 2011 Sanofi SA Earnings Conference Call
`
`Hanspeter Spek - Sanofi - President - Global Operations
`
`I will take conversion. Yes, I think 40% is not a better size. You will remember it was a matter totally dominated by cartridge so that's already the
`answer to the second part of the question, what do we do? We favor everything commercially from a promotional point of view, which goes into
`conversion and we de-favor anything which would keep the market on cartridges.
`
`Can we bring the market to 100%? I don't think so, because I think as we grow we are right. Would you like to grow faster? Yes. Yes, perhaps on
`the other side we have to see that there is still a market of non-pens where we also have to continue to make offers with Lantus that are not in
`pens. But I think 40% today -- 50% today where we have been I think in 2005 or 2006, 10% or 15%, it's a good rate.
`
`Chris Viehbacher - Sanofi - CEO
`
`I think it's fair to say that we have really increased our efforts in this in the last two years and that includes pricing and other commercial terms in
`addition to promotion.
`
`Elias Zerhouni - Sanofi - President - Global Research & Development
`
`Absolutely, we are continuing with the development of devices that could give you fixed flex so that you can titrate the insulin where we think it's
`important for patients. I don't think you have the ability -- I mean, the fixed flex for us works well, because lixisenatide has a fixed dose. It's either
`10 or 20, so there is not a lot of complexity to that, but we have -- this is what we pursue. I mean, we have a devices for sort of back up and aiming
`for starting Phase III with a commercial device in 2013.
`
`Alexandra Hauber - JPMorgan - Analyst
`
`But it's still not finalized since it's only in the year where are you initiating, or have you nailed it now?
`
`Elias Zerhouni - Sanofi - President - Global Research & Development
`
`Pretty much. I mean, all you have to do all the PK/PD trials obviously for that before you start your Phase III. So we're ongoing through that and we
`have primary devices back like every development plan.
`
`Chris Viehbacher - Sanofi - CEO
`
`So in other words, to be clear, the device is fixed.There is a backup device, so we are not tinkering with the device at this stage.
`
`Elias Zerhouni - Sanofi - President - Global Research & Development
`
`Yes, we are just making sure.
`
`Chris Viehbacher - Sanofi - CEO
`
`We are going through the PK/PD studies in the device to make sure it's valid and we are able to get authorization to go into Phase III with it.
`
`THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us
`
`©2012 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without
`the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated
`companies.
`
`28
`
`Mylan Ex.1064
`Mylan v. Sanofi - IPR2018-01676
`
`