Patrick O'Brien - SVP, IR Denny Lanfear - Chairman, President and CEO Lisa Bell - EVP, Global Regulatory Affairs Jean Viret - CFO Matt Hooper - EVP and General Counsel Lisa Bell - EVP, Global Regulatory Affairs Vince Anicetti - EVP, Global Quality Michael Fleming - EVP, Commercial Strategy.

Mohit Bansal - Citigroup Chris Schott – JPMorgan Ian Somaiya - BMO Capital Alethia Young - Credit Suisse Jason McCarthy - Maxim Group Morgan Williams – Barclays Ken Cacciatore - Cowen & Company Michael Ulz – Robert Baird Umer Raffat - Evercore ISI Douglas Tsao - Barclays.

Ladies and gentlemen, thank you for standing by, and welcome to the Coherus BioSciences First Quarter Earnings Conference Call. My name is Aila and I will your conference operator for the call today. At this time, all participants are in a listen-only mode. And as a reminder, this conference call is being recorded.

I would now like to turn the call over to Patrick O'Brien, Senior Vice President of Investor Relations. Please go ahead..

Thank you, Aila, and good afternoon everyone. After close of market, we issued a first quarter financial results press release. This release can be found on the Coherus BioSciences website.

Joining me for our prepared comments today will be Denny Lanfear, President, CEO and Chairman; Lisa Bell, EVP of Global Regulatory Affairs; Jean Viret, CFO and Matt Hooper, EVP and General Counsel.

Before, we being our formal remarks, I’d like to remind you that we will be making forward-looking statements with respect to our product development plans all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause actual results to differ from these statements.

A description of these risks can be found on our most recent Form 10-Q and filed with the SEC. In addition, Coherus BioSciences does not undertake any obligation to update any forward-looking statements made during this call. I would now like to turn the call over to Denny..

Thank you, Patrick. Thank you very much and thank you all for joining us today. A few things we'd like to cover with you. First of all, we'll review progress on our lead AUC program CHS-1701.

We'll tell you a little bit about some of the inspections that we've had; we'll do a legal and patent dance update, talk a little bit about the BLA itself and then recap where we are in terms of the EU MAA.

We’ll then go ahead and talk a little bit about CHS-1420, our Humira biosimilar, particularly the filing the 135 IPR issues and a few other issues. We will also address the follow-on pipeline CHS-0214, our etanercept biosimilar; CHS-131, our small molecule for MS, so on. Now we will also provide you with a licensing update.

So let me start today with an inspections update on CHS-1701. As we previously disclosed we had an FDA inspection of the KBI manufacturing site in Q4 2016. There has now been subsequent communication from FDA indicating that they consider this inspection to be closed and all observations resolved.

What this means in layman's terms is that the responses to the 43 observations are deemed to be successfully addressed. Further, I can let you know that we've had GMP inspections of our Redwood Shores headquarters and the results of that was no 43 observations.

Finally, we have also had various inspections at the clinical sites involved in the 1701 program but no material observations. I'll be happy to take any additional questions regarding the inspections during the Q&A session.

With respect to the patent dance, as previous announced we've completed the initial phase of such with Amgen and pertained to the intellectual property throwing the last in Coherus BioSciences’ pegfilgrastim.

Two of the patents originally listed by Amgen in the process have resulted -- reached agreement on a single patent for potential litigation, that is US patent 707 which actually was the subject of a press release by the company recently.

As you may recall this particular patent is directed to a method of purifying the product using a combination of salt and hydrophobic interaction of chromatography. As we stated in our press release at that time the company does not use hydrophobic interaction chromatography in its process and there is additional issues regarding this patent.

Lastly in terms of next steps, as you know Amgen must decide to sue by Malebin [ph] or otherwise lose the right for preliminary injunction and so on, so that is something we're happy again to discuss during the Q&A.

In terms of the Supreme Court, having completed the initial phase of the patent dance, this means that we have provided Amgen with a copy of the 1701 BLA. We have also provided Amgen with notice of our intent to market our pegfilgrastim commercially in the United States.

We of course closely observe the relevant arguments at the Supreme Court in the case of Sandoz vs Amgen. As you know this decision is anticipated in late June and we’d just add that until the Supreme Court decides otherwise we will of course observe the current BPCIA interpretation, that is 180 day waiting period.

We will not handicap which way we think the decision will go but we are happy to talk about our impressions during the call and the company's general counsel Matt Hooper is here with me today. Now a little bit about the BLA status for 1701. The FDA continues to work on the 1701 BLA and the BSUFA action date of June 9, 2017 stands as it is.

With approximately thirty days remaining before the BSUFA action date, whoever raises the possibility the FDA may not convene an advisory committee meeting as the company has not received notice of such date thus far.

We have no reason to believe this reflects negatively on the status of the application with respect either to the timing or the likelihood of approval of the product. We would note that the FDA is not required by statute to have advisory committees and the FDA makes these decisions on a case by case basis.

Further, and the outcome is not a requirement for a biosimilar in particular as has been evidenced recently with other products. Regardless the company has continued to prepare for potential FDA advisory committee, it will be ready if such is called. Now with respect to the EU, I’ll make a few comments.

As you know the MAA was filed in the EU in November of 2016. We subsequently received the day 120 questions. In our view these questions are all very reasonable and very much in line with our expectations. We are working through the responses to these questions and we do not foresee any issues in providing such a reply.

We continue on track with the European market approval anticipation for fourth quarter 2017. Our global head of regulatory affairs Dr Lisa Bell is with today and during Q&A please feel free to ask her any questions pursuant to this application. On the commercial side in the U.S.

for 1701, we continue to build out our commercial capabilities in sales and marketing. We have expanded our presence to several oncology meetings and take other action. We continue to target a second half of 2017 launch as previously guided. Now let me talk a little bit about CHS-1420, company’s Humira biosimilar.

As you know, we have previously guided to a 351-K BLA submission in the U.S. at or near the end of Q2 2017 and we continue with that guidance. As you also know there is going to be final PTAB adjudication of the 135 patent on it before of May 17, of 2017, perhaps in the next week or so.

The oral arguments occurred February 16 of 2017 and in our view those arguments and the judge's questions were very consistent with their previous comments by the judges when they made the IPR institution. We remain guardedly optimistic about the outcome here but we decline to predict the actual outcome of course.

Consistent with our previous guidance we anticipate the initiation of a PK study with a new formulation in the second half of 2017 potentially gated by the 135 decision in May. As you also know we filed four IPRs on patent 619 directed at buffer free formulations and we await institution decisions on these on or before September 12, 2017.

Now with respect to the company's anti-TNF etanercept CHS-0214 we'll continue to guide toward MAA filing in the second half of 2017. With respect to CHS-131 the company's legacy small molecule in multiple sclerosis we are completing additional animal studies to validate the mechanism of action and we anticipate initiating licensing discussions.

Upon those completion, we are targeting license agreement in the second half of 2017 for this product. Finally, let me recap our partnering objectives. Firstly in terms of EU with 1701, we continue with the commercial partnering discussions and we are targeting having an agreement in place in the first half of 2017.

With the anti-TNF we are targeting to partner an agreement in second half of 2017 subject to the 135 IPR decision. And then lastly as I indicated in terms of CHS-131 partnering agreements are targeted for the second half of 2017. I’ll now turn the discussion over to Dr. Jean Viret, company’s Chief Financial Officer..

Thank you, Denny. Cash, cash equivalents, short term investments, and marketable securities totaled $174.8 million as of March 31, 2017 compared to $124.9 million as of December 31, 2016. Cash used in operations was $73.3 million in the first quarter of 2017 as compared to $76.3 million in the first quarter of 2016.

Cash used in operation was approximately 16% less in the first quarter compared to the fourth quarter of 2016 which had a cash used in operations of $86.9 million. Total revenue for the first quarter of 2017 was $161,000 as compared to $12.4 million in the first quarter of 2016.

The decrease in revenue is a result of a termination of our agreement for CHS-0214 with Shire plc whereupon Coherus regained rights to CHS-0214 in the third quarter of 2016. Research and development expenses for the first quarter of 2017 were $53.8 million compared to $65.3 million in the same period of 2016.

The decrease in R&D expenses in the first quarter over the same period in 2016 was mainly due to completion of CHS-0214 clinical programs that was offset by an increase in personnel related costs allocated across our biosimilar product development efforts.

General and administrative expenses for the first quarter of 2017 were $18.8 million compared to $11.4 million for the same period in 2016.

Changes in G&A expenses were mainly attributable to an increase in legal and other professional fees to support our intellectual property strategy and personnel related costs to support CHS-1701 pre-commercial activities.

Net loss attributable to Coherus for the first quarter of 2017 was $74.8 million or $1.54 per share compared to a net loss of $65.4 million or $1.67 per share for same period in 2016. We’ll now turn the call to Q&A. Operator, you may open the call to questions. .

[Operator Instructions] Our first question is from Ian Somaiya with BMO Capital..

Thank you and thanks for taking my questions. I had two; first on the manufacturing side just as it relates to 1701, can you just confirm the FDA’s greenlight of [indiscernible] for that product and then I had one other question. .

I'm going to have Vince Anicetti, company’s executive vice president of global quality, reply that.

Vince?.

Thank you Denny. Yes our manufacturing partner for drug substance KBI Biopharma received notification from FDA that FDA considers the inspection of KBI closed and inherent within that is that our responses to all of the observations were deemed acceptable. .

And just one other question I had was on the day 120 questions, I don’t think you sort of speak to the nature of the questions and whether you think there will be any major sort of datasets that might be required to answer any of those questions?.

I’ll turn that over to Dr. Lisa Bell, our global head of regulatory affairs. Dr.

Bell?.

Hi, so in terms of the questions we’ve been receiving the questions, the questions are reasonable, we've actually been addressing them in a pretty fast timeframe as quickly as they've asked us to provide them. Right now we have no expectation of any questions that would require an additional datasets to be provided..

And if I could just, as one final question, completely unrelated to 1701, or the TNF assets.

Just looking at the biosimilar Lucentis opportunity, I was just hoping you could speak to maybe the clinical requirements or regulatory requirements for bringing that product to the market?.

That's a great question. We have prepared a clinical program for the Lucentis biosimilar. However we would decline to disclose such program publicly at this point. As you saw with CHS-1701, our pegfilgrastim asset, we believe that our clinical development paradigms are a distinct advantage for us.

You will hear more about that program however in the second half of the year but forgive us for not talking about the specifics regarding the actual clinical program at this time. .

Our next question is from Mohit Bansal with Citigroup..

I have one question regarding the Onthro device, and given that the use of Onthro has been increasing, to what extent do you think it is practice changing for doctors as well as nurse practitioners that it could become a big obstacle when you launch a product?.

Thanks for the question. As you may know from our previous conversations, we view the conversion to Onthro as cannibalizing the same such market. This primarily is due in our view to a two or three percent discount. If you consider that the ASP reimbursement is about 4.6% or so, such a additional discount would represent perhaps a 50% increase.

So we're not surprised that it has been converted so rapidly. As you know we have conducted many studies with those in oncology regarding the device. We remain convinced that the Onthro adoption is quite reversible upon various contracting approaches, and we look forward to do that.

That being said, as you also know we have initiated development of our own device as we believe there is about a 15% or so actual part of the market that benefits by remote administration .And we don't want to leave any segment on a drug. .

Our next question is from Chris Schott with JPMorgan..

Just a couple here. Maybe first just talking about the 1701, and I appreciate all the comments on the call and the color.

At this point I know there's no panel but is there anything in the review process thus far that's either been surprising or suggest the review is not progressing on track?.

Thanks for that comment, Chris. I’ll let Dr. Bell address that.

Lisa, would you care to offer what comment you can?.

Sure.

Hey Chris, so I mean as far as the review has been going, I’d say it's ongoing and this reflects the standard process for a biosimilar review and maybe it is just worth – because I'm not sure this is a level of detail that is clear to everybody, right? Biosimilars unlike new drugs are under actually different review paradigm, and what that means is for a new drug a few years ago, they moved to a review paradigm that involved pre-set milestones where the FDA communicates to the sponsor where they are in their assessment of the application and what questions they might have .Well, with biosimilars we're not there yet.

In fact, that's something that we anticipate will be moving to next year with BSUFA 2. And while this sounds like the level of detail is important because it just means that on the biosimilar side FDA will progress through their review, they’ll send you questions and that will all be very typical of their review.

They don't have necessarily preset milestones by which they have to communicate to the sponsor where they are of the same. So this is -- we think in that respect is following a standard biosimilar review. .

We realize that this of course is a very interesting topic for investors and folks want to read very deeply into things, but I would just caution any reading into this in a negative or a positive by the FDA is proceeding with the review. And we're going -- we're in communication with them so that's really all the comment we can provide you on that..

And then just a couple other quick ones, just so I am clear on this.

With the patent dance in the 707 patent, can you just – just so I am clear on this, talk through the process from here, what do you need to do to the extent that Amgen does one – I mean, that you get some very strong arguments of why you wouldn’t infringe on this, but just walk us through the pathway of just clearing that patent as we think about the potential launch of this drug and any showdowns that could involve?.

So I'm going to let Matt Hooper, the company’s general counsel get back to you on that.

Matt?.

Thanks Denny. So as we said in the press release, Amgen to the 11th, which is this Thursday, to file litigation under this patent as agreed in the patent dance and is required, if they do not then they’d lose the right to seek preliminary injunctive relief.

Now we don't have any certainty as to whether they will or they won't but if they do bring litigation under this patent, Chris, what will happen is the case will start off like any other patent infringement case.

I suppose you could expect there will be a request for preliminary injunctive relief and then the parties will schedule various matters in the litigation and there will probably be a fairly expedited path to reviewing any arguments affecting infringement and invalidity.

So the immediate goal for us would be of course to raise our defenses and push back any motion for preliminary injunction. Conversely, the goal for Amgen would be to win a preliminary injunction which we think is exceedingly unlikely with this patent. .

A final question but if I didn't want to interrupt if you're continuing there. .

No, we’re okay. Go ahead..

Just my final question, just maybe shifting gears to 1420, to the extent that 135 patent falls, can you just walk through the clinical and legal hurdles that you need to navigate to get to that kind of 2018 type of timeframe get to market? I know you get the PK study on the alternative formulation to 166 that’s starting later this year.

But what are the key things we need to be watching from your perspective to hit those timelines?.

Yes, as we’ve indicated earlier, the strategy to move forward comprised of three key parts. First of all, you have to have a formulation which is robust and efficacious and keeps the protein in solutions and without changes and stable et cetera.

The second is you need a clinical program to show that you don't have an impact on the pharmacokinetics in a human. The third is you need a legal strategy also that is integrated with the clinical and the research strategy.

So what you have seen us do in terms of the advanced formulation is move forward with additional formulations with who’s talked about, we have further disclosed that we intend to do pharmacokinetics studies in the second half of 2017. And then I think that you can assume that we believe our formulations are all quite robust.

So I would stop there as, in terms of describing our ultimate strategy for the formulation is primarily for competitive reasons, but I would point out to you that we think all three of those parts are very very important. .

Thanks so much. .

Okay, I do have additional comment. I wanted just to loop back just briefly, Ian asked a question at the beginning regarding the fill and finished, and any inspections of -- any concerns we might have about that.

I know that others in the field have from time to time had fill and finish problems in various facilities with FDA, and I'll just ask Vince Anicetti to make any comments regarding the fill and finish inspections and how we feel about that.

Vince?.

Thank you. We did have a pre-approval inspection at our fill and finish site in January of this year, lasted for five days with a number of FDA inspectors. We received a few 43 observations at the end of this, all of these I would characterize as non-product related and relatively routine related to technique at the site.

The sites responded to all of those, we believe where we have meaningful corrective actions and so we think that that inspection is successfully concluded. .

Our next question is from Alethia Young with Credit Suisse..

Hey guys thanks for taking my question. Maybe two for me; one, I guess just maybe talk a bit more -- I know you really probably don't want to – but on the puts and takes of maybe biosimilar Epogen having a panel at the end of May, maybe versus you guys not having a panel.

And then just also I guess relating to that IPR, if you guys you’re your IPRs have not been validated, do you think that Boehringer Ingelheim would be -- or are there any similarities or differences between the two IPRs?.

So thank you, Alethia, for your question. I’ll first feed that up and then I'll let Matt add a little more to the Boehringer Ingelheim differences in arguments. Now I’ll let Dr Bell talk a little bit about the EPO advisory committee.

But let me let me first say that there are two cases on 135 and so there's actually two opportunities to serve that patent.

As I indicated earlier we thought that most of the oral arguments were very very consistent with the judge's initial questions and how they interpreted for example their claims construction and prior art, which I think are the two key issues here. I’ll let Matt Hooper talk a little bit more about the Boehringer Ingelheim IPR.

Matt, any observations?.

Yes, Alethia, the arguments that were presented by both companies were quite close and I think the cases were very effectively presented. Our view is that we think there's a decent chance that we could -- we should have an invalidation of the 135, in which case that would make the subsequent decision on BI IPR move.

On the other hand, if we do not win the IPR, and the patent is upheld in our contest, it's possible that BI might somehow score a victory in whatever differentiation the panel may see. We see that as unlikely.

I think the panel is -- the two panels for which there is overlap in the judges we think it's quite likely that they will view these sort of as a monolithic determination and they will either uphold the patent or invalidate it. But we don't see sort of a split decision coming out of these two separate IPRs. .

And I am going to let Dr Bell address the issue pursuant to the Egogen biosimilar outcome..

Yes. Hi Alethia, so we’re aware of the EPO outcome that’s coming up. I mean I think again the fact that the FDA chooses to take the option to call on an advisory committee for EPO is absolutely their prerogative.

As Denny mentioned earlier, the need for advance similar advisory committee is ultimately the FDA’s decision and the fact that we haven't yet been notified I don't believe is a comment either way on the status or approvability of our application. .

The other comments I would, Alethia, is Epogen is a very very complex molecule. In terms of glycosylated molecule, it is quite difficult to replicate unique, further the patient population is a very delicate one. And then lastly with pegfilgrastim, it's possible to see a very immediate response within a couple of days whether the product is working.

And then lastly I'd say we have very very robust analytical data which dovetails with the clinical data. So I think it's a bit of apples and oranges in terms of these two types of molecules. One's an E coli molecule that’s pegylated and one is a toll [ph] molecule that's glycosylated and very sensitive. .

To clarify one thing on the fill and finish. So all the issues related to the fill and finish are now resolved to your knowledge or are they not? I just didn’t catch up on the question..

All of the issues regarding the fill and finish have been formally responded to, to the FDA. As you may know, the FDA often does not formally say that these are acceptable, we have not heard anything back at this time.

But as I mentioned the inspection was in January and if there were something I think that was of significant concern to them we would have heard a response by now. So we assume that these were all acceptable. .

Alethia, I think it's fair to say we have a high degree of confidence around the fill and finish operation and this particular issue. .

Our next question is from Jason McCarthy with Maxim Group..

Hi guys, thanks for taking the question. If I could just go back to 1701, can you just give us an update on the commercial preparations for launching 1701, maybe narrowing down the timing this year as well as distribution, how much bulk has been made? Just trying to get a better sense of the launch that could come as early as this year. .

Hi, I let Michael Fleming, the company’s executive vice president of commercial answer some questions. However we will not provide guidance pursuant to bulk – amount of bulk and so on. But Michael would be happy to tell you a little bit about some of launch preparations and his team.

Michael?.

So as Denny said earlier we're guiding the street to a potential launch in the second half of 2017 and we’re preparing our commercial organization accordingly, building our commercial capabilities, our marketing sales and market access capabilities to address the first potential first in position opportunity.

We're developing our value chain, our distribution relationships with wholesalers and GPOs. And we're preparing our marketing programs and campaigns for launch and assembling the appropriate personnel. Beyond that I'm not sure I would comment. .

However I would say on the following call assuming our approval at hand, Michael will be happy to provide you some additional detail and color around the launch and strategy. .

Our next question is from Morgan Williams with Barclays..

Hi good afternoon; thanks for taking the questions. So just one quick question on 1420, so you’ve said that the filing is expected the second half of the year and I think a few of your sites – I think it seems like it's in the earlier half of the year.

Just thinking about the bridging study that you are doing to the new formulation; does this spend still fall under the standard biosimilar review that Dr Bell was speaking to? And then I just have one quick follow up on another topic. .

Hi Morgan, thanks for the question. So I'll let Dr. Bell reply to the specifics of your question but I want to clarify that we are guarding -- we are guiding to end of first half of this year – more to file on that and second half for the PK study.

Lisa, some additional sure?.

Sure. Morgan, just to make sure I get your question right. I think you're asking what would be the approach for the review of a post-marketing change for a new formulation? And as you know, as Denny just mentioned, the 1420 application is targeted for a second – Q2 – end of Q2 this year.

That one will be going in before the BSUFA [ph] is implemented and then so it will be under the same kind of review process that we’re undergoing with 1701 now.

Then that change in the review process is only for your first application and for anything like a post approval change, it's just a standard review, there's no difference between a new molecular entity and a biosimilar. .

So I guess -- just to clarify, so thinking about the – since you’re looking to bridge the new formulation that does not infringe on the 166 to the formulation that you would then file.

I guess I'm just hoping to get some clarity on kind of how the filing works, if you're submitting the BLA into Q but then you're doing this bio-equivalent type study at this – second half of the year?.

So Morgan, what you do is you file and then that file is BSUFA 1, that’s a ten month clock. When the 10-month expires you presume approval and then you can file any post approval supplementals thereafter. And so this would be in the second half of this year post filing, so this would necessarily be filed post approval. .

And then just my second question, so as you’re looking to partner the anti-TNF franchise, obviously you're thinking about the 135 decision.

But just in general how are you thinking about valuation for that portfolio and what comps are you looking to and what kind of deal structures would you prefer to see?.

Well, that's a great question of course. We believe that the company will be in a very good position both with this product and with 0214 as we have retained almost global rights to both these products. So with 1420 we have U.S. rights, E.U. rights, China, Japan all the major territories with the exception of ex-Brazil.

Same thing with 0214; so we think further that there is synergy between these two assets in terms of the treatment paradigm and the implied clinical inter-changeability of the patients.

There are various comps that one could look at in terms of this, but our desire as we've said previously is to retain approximately 50% value downstream backside and pull remaining value forward. We look to these assets to provide additional non-dilutive funding as we go forward in the second half of the year.

But that being said we'll wait until we get past 135 and start a process and then be happy to give you some additional guidance at that point. .

Our next question is from Ken Cacciatore with Cowen & Company..

Hey Denny, I was wondering if you're in settlement discussions with Amgen; that’s the first question. And then the second question for Matt. Matt, if Amgen sues you, how would the federal judge let you launch if you can’t indemnify on damages? I am just thinking about your balance sheet and potential damages you would incur. Thank you. .

Well, Ken, you know, of course if I were in settlement discussions with Amgen, I would be precluded from disclosing such with you. Now I would make one further point here about the patent exchange process.

We have come down here after some time of -- many years of development to one patent on hydrophobic interaction chromatography, which is a chromatographic method the company does not use in its processes. So we feel rather confident that we have not violated these patents of Amgen, refolding patent and others.

You may recall that a year and a half ago when the refolding – I mean these other plans came up we guided street towards not infringement non-use of such techniques and patents, and that in our view has been validated by the process. Now it is true that this patent does exist, but I think that our anxiety level over it is relatively low.

To your second question, I’ll let Matt Hooper go for it.

Matt?.

Ken, I think if we get to the point where the judge doesn't want to grant a preliminary injunction because he doesn't see likelihood of success on the merits. The remainder of that analysis I think would require me to expose more of our legal thinking than I'm prepared to at this time.

I think for the most part our PI strategy is to demonstrate very clearly to the court that there is a very low likelihood of success that this patent could be asserted. In terms of how the rest of the PI factors would be argued and prepared for, I can't really comment on that. .

Our next question is from Michael Ulz with Baird..

Hey guys thanks for taking the question. Maybe I can ask a follow up on 1701.

It seems like everything's on track there with regulators but maybe you can comment on whether your interactions with the FDA and EMA have been fairly consistent in terms of type of questions you're getting or have been any noticeable differences?.

Just let me clarify.

Is your question that EMA and FDA have different sets of questions or different approaches? OK, I just get – Lisa, what can we say anything about that?.

I mean without getting into specifics, I would say, first of all these two agencies are both highly rigorous scientifically. So not surprisingly they're going to take a very thoughtful approach to each of their reviews and in some cases there's going to be overlap dramatically even if the specifics of the questions may be slightly different.

And I think that's a fair way of kind of characterizing what we've seen and heard from either of them. And again as we said earlier everything that comes through has been reasonable and I think within our expectations. .

Our next question is from Umer Raffat with Evercore ISI..

Hi, thanks so much for taking my questions.

Denny, what would FDA need to establish the stability of your non-buffer formulation and how different is your PH in the buffer versus your own non-buffer formulation one? And a second, this you may have commented on, I'm still wrapping up; the formulation that you're filing right now on Humira – the biosimilar Humira.

My question is on three parameters; a) does it have a buffer? B) does it have a surfactant? And three, does it have polyol? And any thoughts on the 619. Thank you so much. .

Well, let me see -- let's start with buffers and protein stability 101. So for any given protein there is a particular PH that protein likes to be in. This is determined primarily off the primary sequence of the protein that is the [indiscernible] protein which are all very defined.

So secondarily it has to be approximately a physiological PH and so on. So regardless of what sort of buffer you put a protein in or what sort of formulation solution, I should say, you would tend to end up as the same formulation PH. Now pursuant to the issue of buffers and non-buffers, so the buffers are way of stabilizing of PH at a certain point.

Now at some protein concentration, that is low protein concentrations, buffers are required to prevent PH strip. However as higher protein concentrations proteins tend to buffer themselves. And so that is, they once put at a certain PH they can stay at that PH themselves without formal buffer systems being introduced.

Thirdly, to the issue of which formulations we have used in which clinical trials, we have of course have not disclosed that for competitive reasons. But fourth, I would be happy to respond to the issue of surfactants and so on.

There are of course a number of ways to keep proteins from bumping into each other and coming out of solution or aggregating or doing the various things that surfactants do. And I think that’s fair to say the company has spent a fair amount of time in the developments of novel formulation approaches particularly with respect to Humira biosimilars.

The company has filed a number of patents and you'll see continued patent activity from us. And as you know, the development of formulations for Humira biosimilars was an area of interest to us very early on. We knew that this was going to be ultimately the intellectual property of battlefield that would be waged in terms of market access.

So it's no surprise to us this is where we are today here in 2017. I'm sorry I can't really give you any further clarity about which particular buffers we use and which one but I can direct you to our patent filings to provide those to you. .

We have time for one more question. Our next question comes from Douglas Tsao with Barclays..

Hi, good afternoon. Thanks for squeezing me in. Just curious you made a comment about 0214 in terms of sort of the decision to move ahead with filing, EU will be based on regulatory feedback. Just curious what type of feedback you are sort of looking to get in terms of moving ahead with that program. .

Hi Doug, thanks. Dr Bell will be happy to offer you –.

Hi Doug, so as part of like all of our programs really we always have a chance to meet with regulators prior to moving into the submission phase, just to ensure that we have understanding and agreement on what they expect to see. So I would just characterize this as a standard meeting. End of Q&A.

With no additional questions, I would now like to turn the call back over to Mr Lanfear for any closing comments..

Thank you and thank you all for joining us today and thank you for support of Coherus. I think we've had a very good Q2 as we've gone forward here in 2017. Very good progress on the filings; good progress on the commercial plan and good progress on the various programs.

We look forward to updating you upon our next call and we'll of course give you material updates in terms of the programs in the interim. Thank you. .

Ladies and gentlemen, this does conclude the program .You may all disconnect. Everyone have a great day..