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

Mohit Bansal - Citigroup Morgan Williams - Barclays Alethia Young - Credit Suisse Chris Schott - JPMorgan Michael Ulz - Baird Tyler Van Buren - Cowen and Company.

Ladies and gentlemen, thank you for standing by, and welcome to the Coherus BioSciences Fourth Quarter Earnings Conference Call. My name is Skyler 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, Skyler, and good afternoon, everyone. After close of market, we issued a press release with the corporate highlights and financial results for the fourth quarter and full year 2016. This release can be found on the Coherus BioSciences website.

Joining me for today's call will be Denny Lanfear, President, CEO and Chairman; Barbara Finck, Chief Medical Officer; Lisa Bell, EVP of Global Regulatory Affairs; Jean Viret, CFO; Matt Hooper, EVP and General Counsel and Michael Fleming, EVP of Commercial Strategy.

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

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

Thank you very much Patrick, and thank you all for joining us today. I'll first review progress on the Company's lead program CHS-1701 and then I will go on to CHS-1420, CHS-0214 and then CHS-131legacy small module. In terms of CHS-1701 we've seen good progress with the BLA over the last quarter. It is progressing as expected.

We continue to interact with the FDA in a normal fashion on the application and we believe that we continue to grasp to progress further action date on June, 09 2017. We continue to prepare for potential advisory committee and we have no date thus far but we will be ready and we've had a number of dry run through in preparation.

We have had certain inspections of manufacturing facilities, as well as other infections but we have no major concerns for the BLA in the context of those instructions. We anticipate no impact to our commercial supply chain.

On the M&A side, in Europe for that product we are expecting our day 120 commence and we would determine the timing of our response upon review of those. We are currently preparing for the European inspection of course.

On the commercial side of CHS-1701, we continue to prepare for a mid-second half of 2017 launch and we believe the commercial potential this product is quite strong and we plan to capitalize on this substantial opportunity.

There is a very large reference market, price growth in the brand has been driving increased demand for biosimilar's and you'll hear more about this little later. We would be happy to take questions during the Q&A.

This pent-up demand we believe will drive sales and we would just guide you as we have previously to some of the Zarxio experiences of recent and we will update you with more specifics on the next call. Turning my attention now to CHS-1420, let me just first give you a program review then I’ll touch upon some of the patents and the legal activities.

And then lastly we'll have a little brief discussion about the BLA status. In terms of the program development, we had a successful PK filed equivalent study there. This was Phase 3 material versus U.S. Humira and as you know from our previous press releases, this met all primary endpoints including AUC, Cmax et cetera.

And this robust result gives us great confidence as we move forward with other formulations we'll be successful. There's couple of other things going on, on the product development side as 1420 I can advise you out.

First of all the in-light portion of two other minor studies, 1420-04 and 1420-05 is now complete and these two studies will enable registration of the auto-injector configuration. There's two additional PK/BE studies 1406 and 1407 underway and these will enable MAA filing in Europe.

On the legal patent side 04-1420, of course you're familiar with the 135 issues moving forward, oral arguments were heard February '16 and there is a file decision we expect on before May 17 terms of that patent. I would point out that the U.K.

Court recently struck down the EU version of this patent citing very similar argument that the Company had in the right IPRs. In terms of the 619 patent and its IPR, the Company filed for IPRs this quarter on adalimumab formulation.

The action data is August of 2017 and as I spoken before this is part of our broader overall formulation strategy for this product. With the successful PK results that I just encapsulated for you, we're now in position to file the BLA as guided for the first half of 2017. Let me turn my attention now to CHS-0214 which is our Enbrel biosimilar.

The Company is prioritizing the 1701 and 1420 BLE activities and there will be some impact on the 0214 finally into the second half of 2017 also on the product proceeds as planned. In terms of the CHS-131 the MS product, we're making very good products there.

We are having some animal studies underway to flesh out the mechanism of action which we believe will be helpful in terms of the ultimate licensees in that product which we project for the second half of 2017. In terms of such licensees, just let me touch on a few key points here first of all U.S. oncology. We continue our - I should say ex-U.S.

oncology. We continue our efforts to license key patents of the onc portfolio ex-U.S. particularly in Europe I think we’re having good progress there and we continue to guide towards a first half of 2017 transaction. On the anti-TNF front, we continue to prosecute that with potential partners.

However we believe that a PTAB decision on 135 in May will be critical to moving things forward in terms of ultimately the licensing of 1420 in the U.S. Now let me turn things over to Jean Viret, Company's Chief Financial Officer to make some remarks.

Jean?.

Thank you, Denny. I will now review our financial highlights for the fourth quarter and year-end 2016. Total revenue for the fourth quarter of 2016 was $844,000 as compared to $10.2 million in the fourth quarter of 2015. Total revenue for the fiscal year 2016 was $190.1 million as compared to $30 million in 2015.

The increase over the same period in 2015 was due to increase recognition of collaboration revenue as a result of regaining the full development and commercial rights for CHS-0214 from Shire in Europe, Canada, Brazil, the Middle East and certain other territories.

Research and development expenses for the fourth quarter of 2016 was $59 million compared $51.4 million for the same period in 2015. R&D expenses for the fiscal year 2016 were $264.4 million as compared to $213.1 million for the same period in 2015.

The increase in R&D expenses in the fourth quarter over the same period in 2015 was mainly due analytical studies for early stage programs and our CHS-0214 programs. Ongoing CHS-1420 pharmacokinetic and Phase 3 trials offset by completion of the CHS-1701 BLA enabling and CHS-0214 Phase 3 clinical program.

The increase in R&D expenses in the fiscal year ended 2016 over the same period in 2015 was mainly attributable to proceeding with clinical activities associated with the Phase 3 clinical study in psoriasis for CHS-1420, advances in other product candidates and hiring additional personnel to support both late development and early-stage activities partially offset by a decrease in costs related to BLA enabling studies for CHS-1701 and a decrease in cost associated with the CHS-0214 Phase 3 trials that we have completed in the first half of 2016.

General and administrative expenses for the fourth quarter of 2016 were $15.3 million compared to $11 million over the same period in 2015. G&A expenses for the fiscal year 2016 were $51.6 million as compared to $36 million over the same period in 2015.

Changes in G&A expenses were mainly attributable to hiring employees to support free commercial and accounting activities, costs associated with stock options granted since the third quarter of 2015 and legal fees to support our intellectual property strategy.

Net loss attributable to Coherus for the fourth quarter of 2016 was $75.9 million or $1.71 per share compared to a net loss of $52.4 million or $1.35 per share over the same period in 2015. Net loss attributable to Coherus for 2016 was $127.3 million or $3.04 per share compared to a net loss of $223.3 million or $6.01 per share for 2015.

Cash and cash equivalents totaled $124.9 million as of December 31, 2016 compared to $159.7 million as of September 30, 2016. Coherus raised an additional $120.3 million in net proceeds from a follow-on equity offering in February and March 2017 and begins 2017 with a pro forma cash balance of $245.2 million.

We anticipate prioritizing use of cash towards CHS-1701 commercialization activities and see non-dilutive sources of cash by partnering our anti-TNF, CHS-1701 and CHS-131 programs. I will now turn back the call to Denny for our 2017 guidance..

Thank you, Jean. Our 2017 guidance appears in our press release and I have encapsulated the most essential part of it in my previous remarks.

I would only add that we expect approval in the MAA in the fourth quarter for CHS-1701 in Europe and the others remain as stated in the press release and we're happy to take any questions on this of course in the Q&A. Thank you.

Patrick?.

Operator, we are ready for the Q&A..

[Operator Instructions] And our first question comes from Mohit Bansal with Citigroup. Your line is now open..

Good afternoon, and thanks for taking my questions. So my question is like two parts, number one is about Neupogen biosimilar and if you look at Zarxio's market share so far they have penetrated roughly 20% market within first year of launch.

So do you think that should be a comparable metrics to look at when you launch your Neulasta biosimilar or do you see any reasons to - for it to be better than what drugs you it. And the second question, I mean I will probably wait and then ask my second question after that..

Hi Mohit, this is Denny. Thanks for the question. And I will let Michael Fleming, the Company's Executive Vice President of Sales and Marketing take the point of these - President for market share and how we think that will shape up.

Michael do you have comments?.

Yes I do. I mean the short answer to your question is, it's a good analog to start with, if you are thinking about pegfilgrastim both are G-SCF one short acting filgrastim and one is long-acting pegfilgrastim. Pegfilgrastim is used almost entirely in the out-patient clinics either standalone clinics or hospital and regulatory clinics.

In addition to those settings, filgrastim Zarxio is used in the hospital in-patient setting and a significant amount is sold in the retail segment. So Zarxio was also arguably a second competitor to Neupogen after Granix whereas CHS-1701 will potentially be the first competitor to Neulasta.

So in this sense from the point of view of commercialization, the pegfilgrastim market dynamics for us is more simple and straightforward as an opportunity. Due to the relatively greater size of the pegfilgrastim market compared to filgrastim, our research indicates there is a far greater pent-up demand for pegfilgrastim biosimilar.

So I think it's a good place to start and we think we could do as well as not better than Zarxio and that's what we would attempt to..

Yes I think, before we get to the second part of your question, Mohit. I think - I think that is an excellent focus and aspiration for the Company is what Zarxio has done, that's an existing 20%.

As Michael said, we think there is considerable pent-up demand in this but we'll take a little better closer look at the competitive dynamics a few months out and revisit this issue for you..

Got it, very helpful. And then the other part is I mean looking at so - looking at your press release you're definitely trying to find a partner for your immunologic franchise, but thinking about Merck KGaA is trying to offload their biosimilar business and then I mean some other of your competitors are also looking for Humira partners.

So I mean lot of previous players who were in the markets are kind of trying to get out, I mean like what sort of pressure does it put on you and then how do you argue that you are differentiated in that regard when there are other players who are trying to get a deal as that?.

Thanks Mohit. I think that it is fair to say that the Company has highly differentiated intellectual property strategy. There are those who spoke about the number of competitors, a couple of years ago and then took a look at how this market was shaping up. Intellectual property is really the key issue with Humira.

As you have heard me say before, each of these biosimilars has a particular aspect to it which defines its difficulty and in way the advantages that I think in the differentiation that Coherus enjoys pegfilgrastim for example is a very difficult molecule in terms of its clinical biology.

Etanercept is very difficult molecule in a relative way in terms of its production and so on in characterization. The issue with adalimumab Humira of course is the intellectual property. So I'm not surprised that folks are shying away from this market and we have predicted for some time that there would be significant attrition.

I’m on record saying only perhaps two or three competitors will actually make it across the line by 2023 and I would reiterate that here. So I think that a robust intellectual property portfolio focused around formulation is very important but it's also of course very important to take on these other patents 135 the dosing patents as well as other.

It's a complex intellectual property in situation that you have to address and I think that to degree that you have done that, to the degree you will be successful and to the degree that I think you can successfully get a partner..

And our next question will come from Douglas Tsao with Barclays. Your line is now open..

Hi this is Morgan Williams on for Doug. So just a couple of questions.

If you end up being unsuccessful with the 135 IPR, what would your thinking be on partnering the anti-TNF franchise specifically would you consider a partnership with some sort of consistent value built-in or another more creative deal structure? And then secondly a lot of has been said about your adalimumab IP and just wondering when you would think about asserting that IP against follow-on biosimilar developers since we have seen some approvals come in?.

Hi Morgan, thanks for the question. So first of all the Company of course would decline to discuss publicly its intellectual property strategy in terms of other potential competitors until the appropriate time.

So we would have to ask you just sort of wait and see on that but I think that investors are certainly capable of bringing these various patent filings and looking at the various dates and understanding them.

The other issue though I think is that in terms of 135 that's firmly blocked in United States of course until that patent falls, but that doesn't affect Europe and other markets in fact 135 in its analog I should say just went down in Europe. So it's still possible of course to do an ex-U.S. although arguably the U.S.

comprises the lion's share of that. So in terms of 135, I think we'll just have to wait and see if not that long, it is going to be May 17, we will see how the cards fall with that but I think if it falls our way, I think it will be a positive catalyst for the Company and also for our partnering efforts..

Okay, thank you.

And as a quick follow-up, can you remind us when we would deal about in potential Adcom on 1701?.

That's a great question. As I indicated in my remarks, we have not heard about advisory committee so far but we do have Dr. Lisa Bell here, the Company's Executive Vice President, Global Regulatory Affairs and perhaps Lisa would like to give you a little more color and observations on this.

Lisa?.

Yes so we obviously are have been working as Denny said earlier - we have been working hard in preparing for an advisory committee and we believe that we're going to be ready irrespective of when the date comes through.

I think it's also important for us to remember and there has been various points made on this both by us and actually the FDA has also publicized things in podcasts and other forms about how they are trying to progress through the year under new administration and also under situations where they are quite research constrained.

So in short this is something that we are monitoring closely obviously we have to do follow FDA because the advisory committee is called at their request and under situations here there research constrained, I think that they are going to try to manage appropriately to make sure that they get the advice that they need when needed..

So just a follow-up - sorry just a quick question for Lisa, but if you do not have an Adcom it is not necessarily a negative or any sort of indicator going into the PDUFA date correct?.

Correct, absolutely correct.

I think that there is a variety of different applications obviously under review for biosimilars and other products and I think it's worth noting that if you look at their current schedule of advisory committee, there are very few they have in schedule, so I don’t see this as a commentary on the status of their review at all..

Yes, there are certainly not obligated to have an advisory committee and I would caution investors not to read anything negative into the fact that we have not been notified about advisory committee thus far?.

Okay, thanks Denny, thanks Lisa..

Our next question comes from Alethia Young with Credit Suisse. Your line is now open..

Hi guys, thanks for taking my question.

The first one, in your comments around the first half for partnership if the 135 is validated, I guess would you expect that timeline to change if it isn’t validated is that exactly how you should interpret that front and I have one more question?.

What I'm indicating too is that 135 will be important to be dealt with one way or another to try to get a licensing deal accomplished in the first half of the year. If it is dealt with successfully and that patent falls then obviously I think we can move - we can move forward directly with licensing.

However if it is not, what we are signaling is licensing will I think understandably be hampered on the products..

And then just a second question on the on Pro for Neulasta or the version that you may create.

Like what are the timelines for that, just give us an update there?.

Yes, we have not disclosed timelines for our - particular device. We did disclose a couple of months ago that we're working on, it is in development and we have not sort of offered the market any particular milestones along it's trajectory of development.

I think it's fair to say which you'll hear something little later in the year on that which is important though that we don't want to leave any segment of the market, no matter how small unaddressed and we believe as we've said earlier that particular segment of the market that generally benefits versus perhaps 15% plus or minus but even that we want to make sure that we address..

Great, thanks..

Our next question comes from Chris Schott with JPMorgan. Your line is now open..

Great. Thanks very much for the questions. Just a couple here, first can you just talk a little bit about OpEx and cash burn for 2017 as you prepare for the U.S. launch of 1701. Any just rough metrics we should be keeping in mind there? And I have a couple of follow-up from there..

Hi Chris, thanks for your question, I'll hand that one over to Jean Viret, our Chief Financial.

Jean?.

So as indicated we actually not put a guidance for 2017 but we did a financing that gives us about $225.2 million in cash. As you can see last year's this was - or you will see when our 10-K is on file, you will see how much we use in cash flow from operations. This is the order of spending that we've had in a typical year I would say in the past.

However going forward, things are going to change and in particular use of cash will depend greatly as to when we're going to start making a material for 1701 and obviously when we’re going to start receiving revenue and we could be receiving revenue this year as you know, it depends on when the Supreme Court adjudicates [indiscernible] you know obviously will have to make material earlier and then we'll have hopefully running earlier and cash coming in earlier.

Vice-versa if we - the Supreme Court does not indicate or it's delayed or sites with the originated Company's, then we would see revenue later in the year if not next year. So as a result, we haven't approached op actually prioritizing their use of cash towards 1701 and get from there. So that's sort of our practical guidance at this point..

Okay. The second question was just on the IP landscape on 1420. Can you just talk a little bit about the ISP landscape for this alternative formulation that you run the PK study.

Just timelines there with regards to a potential 2018 introduction, is there any other - beyond 135 any other IPRs et cetera we need to be watching that would be rate limiting to our 2018 introduction..

Hi Chris, I'll let Matt Hooper, the Company's General Counsel comment little forth, but first let me just make a small correction. The PK study that we did was with the material from the Phase 3, so we have not stated that this material and this PK study was subject to any particular patent 166 or 619 or others.

Second thing is that, we have not offered guidance to the street as to when we would file with additional formulations and so on and just exactly what they would be primarily for competitive and strategic reasons.

However, and as the patent landscape for the formulation is a bit complex and I'm happy to let Matt Hooper offer you some additional commentary.

Matt?.

Thanks Denny. You see that we filed IPRs at the end of January direct to 619 patent and Denny commented on the differentiated IP strategy. And the fact that we had multiple formulation options that we are advancing is part of that strategy. The 619 patent is directed to formulations that exclude buffer.

So we look to formulations that contain buffer and those that do not.

And as we've said before, our primary objective is to preserve maximum optionality and sort of weave the development of formulations in with our understanding the patent landscape in a way that we believe can mitigate risks and maximize our ability to get to market without being stopped by formulation IP.

Again I will offer you one observation in terms of Chris and that is we intend to first get passed the 135 IPR hurdle in May. That's obviously a very important one. That is the therapeutic use of patent of course. That's one thing you really can't engineer around. So we think it's important to get pass that.

And then we see the intellectual property Plainfield moving directly to formulation upfront center and as you've seen we've laid out that strategy for a number of years and we are now watching it play out in real time..

Great. And one last just really quick one, just coming to an eelier question on the Adcom. I thought one of the goals with FDA was to hold the panel for the first biosimilar for any given innovator product. I think you're referencing some resource and strength et cetera.

Just anything you're hearing from FDA or just any reason to believe that trend may not be the case here, just want to make sure I was clear with your comments you made earlier..

Yes, I think I'll let Lisa Bell our Executive VP of Global Regulatory comment more but I think it's fair to say that statements of the pad and the statements are now under two very different regimes and conditions. Lisa can you offer Chris a few more observations..

Yes, I think what Denny just said was absolutely right. Under any kind of the agencies making trends about how they by their resources, it's really in the context of what they know they have access to as the government agency.

Plus there is other things that has kind of been advocated by the administration that I think are also weighing into their decision making about how and went to take different products through advisory committee but I think the point still stands, the advisory has caused on their behalf, they can make a plan to do so and then that plan can get revised.

I mean I don’t think that - I don’t think this would be the first instance of that were to happen.

So even if they have said something in the past what may happen as time goes on, as they have more experience, as the advisory committee’s become a little bit more routine, you’ll recall that the last one went through similarly with that problem, so I think as a whole these advisory committees are getting much more comfortable with the concept of biosimilars and the various topics around them..

The other comment I would make for you Chris is, is we view all of these dynamics as positive for the biosimilar business in general and Coherus in particular as a leading pure play biosimilar Company.

Whether you hear incoming FDA folks talk about pricing or faster approvals or any of these issues, we think that biosimilars are a win-win situation all around for access to the patients, for cost constraints with healthcare system, for all these things.

And so we believe that the Company's has positioned with its products in the right place to right time help to solve these problems. And so we see all this as a very, very positive for us..

Great. Thanks so much for the color..

Our next question comes from Mike Ulz with Baird. Your line is now open..

Hi guys, thanks for taking the question. Maybe I can just ask sort of follow-up question on the advisory committee meeting for 1701. Just wondering if you can comment on the types of questions you're preparing for from the FDA just given that we've seen some other filers run into some issues. Thanks..

I would observe that Coherus was the first company - the only company so far to have dedicated [indiscernible] study and also very novel pharmacokinetic BE study which address the inner patient variability which is one of the key issues that you see.

Some of the other folks you know in Europe had their applications run through a little bit of turbulence over the pharmacokinetic studies and indeed this is very difficult product to develop I think in terms of its clinical biology.

But I think we have developed excellent data on both those fronts so we have high confidence in our application and our molecule and how we move forward.

So that's the reason why I think that we're confident that we will move forward on schedule as we think but on the other hand you are in a review and Lisa and her team I think are doing an excellent job in their conversations back and forth with FDA and as things move forward.

Lisa, any additional comments on that?.

Yes, I would - Denny said, I think that the - as Denny think our - we try to take a broad approach to making sure that we're prepared to - we can obviously speculate on any types of questions that agency make raise to an advisory committee.

But I would say as the pre-standard relative to the types of things that have gone before advisory committees before and therefore probably not very noble..

Great. Thank you..

[Operator Instructions] And our next question comes from Tyler Van Buren with Cowen and Company. Your line is now open..

Hi guys, good afternoon. Thanks for taking the questions.

Just got few questions on 1701 and a final question on 1420 but just with respect to 1701 maybe you could just give a little granularity in terms of the ramping up of the commercial operations and when you will be ready to launch assuming approval, how many people you plan to originally launch with.

And then also with respect to the Onthro device, even though it's a small portion of the market what kind of conversion are you seeing there currently and how do you think about patients potentially not having to go to the doctor's office or to the hospital and how would you counter detail around that.

Also with respect to coverage, maybe just speak a little bit about how you expect coverage to evolve over the course of the first year to with launch obviously related to potential part D coverage et cetera..

Okay. Bit of a long question there Tyler, thank you for it. We are clearly in a transition year, as I indicated in my remarks we are currently running our launch team and putting in place the supply chain infrastructure internally to be able to address the market in consideration with the manufacturing and number of other things.

In terms of the ultimate penetration of the market that we expect in the first year, I think we've covered that in our previous disclosures and presentations and so on and as Michael Fleming has indicated, we think that 20% exit percentage at the end of the first year is something to aspire to but again be very careful that we have not established guidance nor we said that we think that we can do that.

In terms of Onthro systems as we see it, we believe that there is - as we said about 15% actual pent-up demand where I should say value proposition were folks that are remotely located actually enjoy the benefits and so on of that.

Now that product has gotten far more penetration that, but we believe that's reversible through appropriate contracting and other types of strategy. So if there is any part of your question, I have not answered happy to offer a little more color if I may..

Okay.

And I guess just maybe on 1420 obviously a lot of focus is on the IPRs and the IPR strategy but once you guys file here soon, how do you expect more traditional legal pathway to evolve particularly focusing on the potential patents and timelines around the decision that has to be made with respect to that?.

Yes I will let Matt Hooper, our General Counsel to take that one.

Matt?.

Yes, thanks Denny. We are not going to comment too much detail about just the legal strategy that could be deployed as when we get into the timing after the BLA. In fact we haven’t publicized whether we are going to engage in patent or not.

I will comment that the litigation timeline can go faster or slower depending upon certain actions that can be taken but beyond that I can't really comment in detail on the litigation strategy that we anticipate..

Tyler, I think the next two steps are the 135 adjudication May 17, then the BLA filing and then we will have another call and we will tell you how things are going at that point. So we will shut the log in front of this here and get through a few of these things and then update you..

Understood. Thank you..

Our next question comes from Ian Somaiya with BMO Capital Markets. Your line is now open..

Hi guys, this is [Andrew Lamp] [ph] in for Ian, thanks for taking the question. Just wanted to see if you can provide some of the feedbacks that you guys are getting from your conversations with payers and physicians.

Specifically what are some of the gauging factors for them in considering switching to biosimilar Neulasta, has it been focused on manufacturing IP or anything else that has been brought up for these conversations?.

Hi thanks, I'm going to let Michael Fleming take that one. Michael would you take that..

Yes, I will.

I mean I think it has been stated on previous calls as the pretty strong pent-up demand for choice and value in this marketplace and our research indicates as long as you can deliver a high quality and reliable alternative, the brand choice is really going to be based on practice economics and our ability to deliver value because that's the largest value driver in the market.

So you're going to deliver quality products that's a probably a function of GMP, it's probably a function of the label and the perception of the molecular match and you've got to be able to demonstrate that you can reliably supply the market. Those are prerequisites for success.

The market is also pretty particular about delivery of patient support services, help services, co-pay systems those sort of things that they come to expect from Amgen for Neulasta. As long as you can deliver those branded benefits, then you can deliver biosimilar value through economic benefits. So that's the feedback that we have got..

I would just add our research also shows that providers and patients prefer a biosimilar manufacturer particularly in the U.S. and not U.S. and Europe and so our material of course is manufactured in the U.S. and we think that's a big plus for us. It is very high quality, it does have an excellent micro match.

And the other thing it is important to is the clinical data and we think that we have excellent clinical data as I indicated earlier, we have both a immunogenicity study and a PK - a very nice PK/BE study with novel design. So we think we are in good shape on both those kinds..

Okay.

And just a follow-up question, what do you hope to learn from the Amgen litigation with AbbVie related to biosimilar Humira?.

Matt would you like to take that one for us?.

Sure. I guess whatever is available in the public record will be closely scrutinized by every biosimilar participants and the public, I think we may begin to learn more about the specific patents that were asserted and what differences has been raised.

And as that information becomes publicly available, we will learn more about where the parties are focusing on the issues but it is just a question of watching the public record..

Yes I would add that, we did read the recitation of the patents in the complaints and none of those were a surprise to us. As you know we have monitored patent landscape very actively and so on. I think that litigation actually got pushed out for a few years so I don't know if there is going to be blow-by-blow as that rolls out over the coming years.

But I think it is also fair to say that each company comes up with their own legal strategy for accessing the market and ours is certainly different than Amgen and others. But they look the patents in of itself didn’t surprise us..

Hi thanks for taking the question..

And we do have time for one more question from Salim Syed with Mizuho. Your line is now open. If your phone is on mute, please unmute it. And with no additional questions, I will now turn the call back over to Mr. Lanfear for closing comments..

Thank you very much. Thank you for joining us today on our quarterly call. As you can tell, the team and I are very excited about the progress that the Company has made on a number of fronts particularly the commercialization and the regulatory advancement we have with 1701.

We think that this will roll-out forward as we go further on the year with the financing out of way I think we are in good position to prepare fully for launch. The 1420 program is shaping up very much along the lines that we anticipate, so that's actually going very positively also.

We thank you all for joining us today and we will see you on the next call. Thank you very much for your support. Bye, bye..

Ladies and gentlemen, thank you for participation in today's conference. This does conclude the program. You may now disconnect. Everyone have a great day..