: Good day, ladies and gentlemen, and welcome to the Coherus BioSciences First Quarter 2015 Financial Results Conference Call. [Operator Instructions] And as a reminder, this call is being recorded. I would now like to turn the conference over to Susanna Chau, Associate Director of Investor Relations. Please go ahead.

: Good afternoon. My name is Susanna Chau and it's my pleasure to welcome you to the Coherus Biosciences First Quarter 2015 Financial Results Conference Call. Joining me this afternoon are Denny Lanfear, President and Chief Executive Officer; and Jean Viret, Chief Financial Officer. At the close of the market today, we issued a press release highlighting Coherus' first quarter 2015 performance. This press release is posted in the Investors section of our website, investors.coherus.com. This conference call contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. This includes statements about the company's current operating plans, financial guidance, objectives and intentions with respect to future operations and products. As such, they are subject to the risks and uncertainties that we discussed in detail in our documents filed with the SEC, specifically, Coherus' quarterly report on Form 10-Q for the quarter ended March 31, 2015, and any applicable amendments, which identify important risk factors that could cause actual results to differ materially from those contained in the forward-looking statements. Coherus has a policy to not comment on financial performance or guidance during the quarter, unless it is done through an appropriate public disclosure. Coherus retains its policy and practice to not update financial performance or guidance during the quarter, unless required by law. On today's call, Denny will provide clinical and business highlights. Jean will provide financial highlights for the quarter ended March 31, 2015, before we open the call to your questions. Denny will then close the call with a few concluding remarks. With that, I'd like to turn the call over to Denny.

: Thank you, Susanna. Thank you very much, and thank you for joining us today here at Coherus. As Susanna indicated, I'm first going to make some opening remarks, and then I will recap the product development advances for each of our key products, in particular where we are with CHS-1701, our pegfilgrastim biosimilar. I have a few comments about our wave 2 products, our pipeline as it comes along and then a few other things. I'm happy to say the company continues to make consistent progress according to plan in all areas. All programs are on track as previously discussed, and we'll give more granular updates as we proceed, program-to-program. We'll discuss CHS-0214, the company's etanercept biosimilar, CHS-1701, our pegfilgrastim biosimilar and lastly, our CHS-1420, which, of course, is our adalimumab biosimilar. On 1701, we'll discuss the BLA-enabling studies and we'll also give a few other key details there. I would note that in terms of 1701, we continue to be highly commercially focused at this point with that product, and we will have some discussion and updates a little further on in terms of our payer outreach and our commercial planning activities. I will give you brief recap and our take on some regulatory developments and some additional guidances released by the FDA in biosimilars, as well as other few comments. And during Q&A, we'll be happy to take any questions you have on the regulatory front also. And then following my remarks, of course, as Susanna indicated, Jean Viret will summarize our financial statements and developments for the quarter, which are overall positive and again very consistent with our plan. And lastly, we'll be happy to take whatever questions you have in terms of Q&A and the business, recent developments. So let me start now really with…

: Thank you, Jean. Operator, we're happy to have any questions.

: [Operator Instructions] And the first question is from Ken Cacciatore of Cowen and Company.

: Just a quick question. AbbVie has been making some discussion about new formulations, new device, maybe fewer injection reactions. Can you just comment about their next-generation strategy, how that might impact what you're trying to accomplish?

: Thank you very much, Ken, for that question. We have, of course, have heard that AbbVie is developing a second-generation product. I don't have any actual details about that product and so forth. I think in terms of our own product, we think that our formulation will compete favorably with those of others. And I think I would just decline to speculate a little bit about -- of AbbVie's actual formulation until there is some sort of a press release or a public announcement regarding its use, I have no first-hand knowledge. However, I can say that our own product is very stable in our formulation, and we think our formulation is quite competitive.

: And the next question is from Chris Schott of JPMorgan.

: This is a Wendy Lin, on for Chris today. Just a couple of questions. I guess first, I'm sure you have been following the biosimilar Remicade launch in major European markets. Can you talk about any update of learnings and how this might inform your commercial strategy for the 0214 and 1420 products? And second, we've heard a lot of discussion recently around label extrapolation. Based on your conversations with regulators and the payers, how comfortable are you that 1420 and 0214 molecule will get broad approval and reimbursement, particularly on GI indications? On the last quarterly call, you mentioned that you're considering additional smaller studies for the HUMIRA program in additional therapeutic areas. How are you thinking about these potential studies?

: Well, thank you for that Wendy. I think that it is fair to say that the issue of indication extrapolation is very, very important to regulators and to payers and to providers and to patients. The best way to assure that you get indication extrapolation is to have a very, very close match analytically with your biosimilar which, of course, we strive to do. Our conversations with regulators would lead us to believe that, if you have less than an optimum analytical match of the product or your in vitro assays do not read out close enough to the originator product, then it brings into question the underlying degree of biosimilarity that you have achieved with particular product. In such a case, I think that the issue of full indication extrapolation becomes a more open question than otherwise if you had a very, very exact match. So for us, we focus very, very closely, as you know, on the match that we get. We have previously disclosed that our match with our etanercept molecule is quite close. I think that we have demonstrated that twice, first, in our pharmacokinetic study, in which we achieved a 98% correlation [indiscernible] there with that product, that's a tough biosimilar, and I think we did very well with that. We have further commented that when we discussed with regulatory authorities, they indicated that we would get the full label extrapolated for that product without any additional clinical studies. So -- and I think, again, that speaks to really the company's technical and scientific competency. Our analytical infrastructure, which is a key part of our platform and our ability to manipulate the metabolism of the cell to glycosylate appropriately and consistently with the innovator, I think that's very difficult to do. And I think…

: And then on the biosimilar Remicade launch in Europe?

: I think that the key takeaway there is it's getting -- that product is getting some good uptake there. I don't have any further comment on that. But I think that overall, we will be watching very closely to see how that goes on in the future. But again, we would expect to do quite well here in the markets that we choose, given the quality of our products. But I think that, that product is moving along quite well from all current indications.

: [Operator Instructions] And I do show we have a question from [indiscernible] of Evercore.

: So I wanted to drill down the IP for a minute. And specifically, you mentioned your platform enables you to work around the formulation patents, et cetera. And so my question is this, how do you intend to get around method of use patents? And then secondly, if you could update us on the status of your pending patent applications.

: Thanks for the question. I think that, number one, if you take a look at biosimilar products in general, I think that you see a broad spectrum of intellectual property coverage. On the one hand, you see composition of matter patents, which I think are quite robust. And to your point about method of use patents, a lot of times you see method of use incorporated in those patents. For example, in some cases it's not unusual to see the method of use coupled with composition matter in the same patent. On the other hand at the far end of the spectrum, I think that you have dosing patents and administering a certain dose of the product and attempts to get intellectual property coverage there, I think that those will be much harder for originators to sustain. In terms of formulation patents, I believe that formulation patents are a primary area of intellectual property coverage. And it's a place where the company focused very early on in terms of both of its products, etanercept, which has an arginine-based formulation from Amgen and also the AbbVie formulation patents around HUMIRA. So our patent filings around our formulations are in the public domain, be happy to send those on to you again. But I think, it's fair to say that that's an area where we chose to focus early on, understanding that it was a key intellectual property issue that had to be addressed. In terms of therapeutic use patents, I think that those -- that depends, I think, on a case-by-case basis how each of those would come out. I wouldn't make any blanket statements regarding those. But as I said, I think they are probably most resilient when coupled with the composition of matter patents. But again, in the U.S., there is a number of therapeutic use patents pending for various biosimilars.

: Got it. And then also on your patent applications, if I may.

: Yes. So as I indicated, we have -- the ones that are confidential I won't tell you about today and the ones that are public, I'll be happy to send on. But I think that it's fair to say, as an organization and as a business strategy, this is something that Coherus, as you know, has focused on very tightly. We have a scientific advisory board of veteran scientific drug developers from Amgen and Genentech, in other key areas. And for each of our products, we take a very nuanced look at all the intellectual properties surrounding that process patents, formulation patents, so all sorts of things. And it's a key area that we focus on in terms of criteria for selecting product candidates. So if there is, for example, to be products that the intellectual property bar would constitute something that we think would be just too difficult or too complex or too much risk, that would be a very -- that would be a significant issue for us. But lastly, what I would point out really here is pegfilgrastim in terms of all these dimensions that you talked about. Pegfilgrastim does not have formulation patents. The expiration of the IP appears quite straightforward, it's already a line extension strategy that's expiring, has a very favorable competitive dynamic. So we -- and actually, it sits very close on for us. So we think pegfilgrastim has a number of very positive product attributes for us that directly impact, I think, a lot of the things that you talk about here. And we'll be happy to talk about this a little more at some point in Q3 as we move towards our commercialization strategy. But I think it's one of the attractiveness of the product as an opportunity.

: And there are no further questions in queue. At this time, I'll turn the call back over to Denny Lanfear for closing remarks.

: Thank you very much, and thank you, all, for joining us today. So 2015 has started out with an excellent first quarter, I think it's fair to say. First of all, initiation of both our BLA-enabling studies for our pegfilgrastim biosimilar candidate. We have expanded our etanercept biosimilar candidate collaboration with Baxter and it now includes our pre-commercialization activities that I've discussed. And lastly, with the proceeds of our follow-on, which is very successful, we're going to continue to work on additional second wave products with the goal of putting additional product into Phase III in 2017, '18 and '19. I would note that the company will be presenting at the Jefferies Healthcare Conference in early June in New York City. And we will also be in Europe, we will be going to the EULAR Meeting in June, and we'll be meeting certain investors in Europe during the month of June, so you might hear more about that. And we look forward to meeting many of you there, if you're there at that time. And thank you very much for dialing in today. And again, we will be happy to take any other further questions that you may have, just give us a ring.

: Thank you. Ladies and gentlemen, this concludes today's conference. you may now disconnect. Good day.

: Thank you.

: You're welcome.