Good day, ladies and gentlemen, and welcome to the Coherus Biosciences First Quarter 2016 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to introduce your host for today's call, Mr. Jean Viret. Sir, you may begin. Jean-Frédéric Viret: Thank you, Kelly. Good afternoon. I'm Jean Viret, Chief Financial Officer, and it is my pleasure to welcome you to the Coherus Biosciences First Quarter 2016 Financial Results Conference Call. Joining me this afternoon is Denny Lanfear, President and Chief Executive Officer; Dr. Barbara Finck, Chief Medical Officer; Matt Hooper, Senior Vice President, General Counsel; and Dr. Lisa Bell, Executive Vice President, Global Regulatory Affairs. At the close of the market today, we issued a press release highlighting Coherus' first quarter 2016 performance. This press release is posted in the Investor section of our website at 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, including Coherus' expectations regarding its ability to advance its CHS-1701, CHS-0214, CHS-1420, CHS-5217 and CHS-3351 biosimilar drug candidates, complete bridging studies for CHS-0214, complete its follow-on PK/PD studies for CHS-1701, filed BLAs for CHS-1701 and CHS-1420 in the U.S., file an MAA for CHS-0214 in the EU, file one IND on a second-wave biosimilar pipeline candidate, enter into collaboration for CHS-1701 commercialization ex U.S. and advance its intellectual strategy for CHS-1420, including with respect to the issuance to Coherus of 3 U.S. patents on adalimumab formulations. As such, we are subject to the risk and uncertainties that we discuss in detail in our documents filed with the SEC, specifically Coherus' Annual Report on Form 10-Q for the year ended December 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 highlight the progress and goals of our business. Matt will cover our recent progress on implementing our IP strategy. I will provide financial highlights for the first quarter of 2016. Denny will cover our product guidance and open the call for questions. With that, I'd like to turn the call over to Denny.

Thank you, Jean, and thank you all for joining us today. As Jean indicated, we have a very strong quarter here in Q1 2016. The company has been particularly focused, as you know, on execution with our programs in what we view as a transformational year for the company. We will provide you, of course, with an update on each of the clinical programs, the oncology programs and the anti-TNF programs as well as the pipeline. But we thought that we would also spend a little time today talking about some of the progress that we have made on the legal front in the context of derisking some of these programs, particularly the Humira adalimumab asset. So we brought along our General Counsel, Matt Hooper, to talk about that, and there's a couple of patents that are issuing as well, is another IPR. In terms of the clinical front, we have advanced all 3 Wave 1 assets towards the regulatory filings very successfully. And in the pipeline, of course, there's 2 programs there, which we'll talk about. In terms of the intellectual property front, specifically in terms of -- oops again, Humira and those issues, we have formulation patents that are about to issue and the IPRs I previously alluded to. This, of course, is a manifestation of our focus on intellectual property, which is one of the key parts of the company's platform. On the corporate front, last quarter in Q1, we raised $100 million in the private placement, which you heard about in February and also happy to tell you that, just recently, we have received $30 million in nondilutive financing in meeting the Baxalta milestone -- performance milestone, which we will talk about. Lastly, I think it's important in the context of the biosimilar business to cite…

Thanks, Denny. Today, Coherus filed its petition for Inter Partes Review, or IPR, of AbbVie's U.S. patent 9,114,166. Generally speaking, '166 patent's directed to a buffered, isotonic and pH-controlled formulation of the adalimumab protein at a concentration of 50 milligrams per ml and suitable for subcutaneous injection. The petition that we put in argues that a pH-controlled adalimumab formulation is claimed in the patent along with the other conventional features that were claimed would have been obvious to persons of ordinary skill in the art of protein formulation. And for that reason, should never have been patented. Our petition is supported by declaration from Dr. Mark Manning, who coauthored and coedited a treatise entitled Rational Design of Protein Formulations published in 2002. Dr. Manning in his declaration points out that, among other things, that before the priority date of the patent, persons skilled in the art of protein formulation already knew that it was standard practice at the outset to optimize pH in a protein formulation and that such skilled formulators possess the knowledge and the ability to do exactly that as part of the rational and [indiscernible] for protein formulation that was already clearly established in the article. In subsidiary claims of the patents, there's reference to a number of commonly used excipients, none of which we believe lend patentability to the claims. So in summary, we generally argue in the petition prior [ph] our clearly taught how to concentrate approaching, such as adalimumab, into a pH-appropriate isotonic formulation suitable for subcutaneous injection. We expect a decision from the PTO by November 2016 on whether to institute our petition. So now I'd like to turn to the patent issuances that we're announcing today. The United States Patent and Trademark notified Coherus recently that 3 of its adalimumab formulation patents will issue this month. These patents are directed to certain buffered adalimumab formulations that can be prepared in the absence of formulation excipients that are known as polyol and surfactants. For example, our U.S. patent 9,340,611 concerns buffered formulations that can be formulated without polyol. Our U.S. patent 9,340,612 concerns buffered formulations that can be formulated in the absence of both polyol and surfactant. And finally, the third patent that we'll issue is 9,346,880, and that is directed to a buffered formulation prepared without surfactant. We have other formulation patents pending, both in the U.S. and abroad. The intellectual property considerations are one of the 4 pillars of our biosimilar platform. The new patents that will issue to us demonstrate the fruits of our formulation development strategy conceived early on in which we recognize the potential importance of evaluating and patenting a variety of alternative Humira formulation embodiments. We believe then as we believe now that this approach reduces our IP risk while at the same time potentially giving us a competitive advantage against competitors that are working on a biosimilar of Humira.

Thank you, Matt. And you'll have the opportunity to ask Matt questions after our prepared statements in just a moment. Let me then turn my attention to the Q1 pipeline update. Last quarter, of course, we announced the addition of 2 products to the pipeline: CHS-5217, an Avastin biosimilar; and CHS-3351, do [ph] Lucentis biosimilar. Consistent with our previous guidance, we'll have more to say about the pipeline's move forward, but you may recall that we intend to file at least 1 if not 2 INDs as we go forward with these products. I'd now like to pass the call back over to Jean, who'll provide some financial highlights for 2016 Q1. Jean? Jean-Frédéric Viret: Thank you, Denny. I will now review financial highlights for the first quarter of 2016. Total revenue for the first quarter of 2016 was $12.4 million as compared to $5.8 million in the first quarter of 2015. The increase over the same period in 2015 was due to increased recognition in Baxalta collaboration revenue as a result of receiving 3 development milestone payments totaling $100 million in 2015. Research and development expenses for the first quarter 2016 were $65.3 million compared to $36.5 million over the same period in 2015. Increases in R&D expenses were mainly attributable to having 4 ongoing Phase III BLA-enabling studies for CHS-0214, CHS-1420 and CHS-1701 in 2016 compared to just 2 late-stage studies that were ongoing in 2015, proceeding with clinical -- preclinical activities associated with our early-stage pipeline and hiring additional personnel to support late development and early-stage activities. In first quarter, we presented a high point of our new spending in 2016, and we project a quarter-to-quarter decline in R&D spending for the rest of the year as we complete various registration efforts. General and administrative expenses for the first quarter 2016 were $11.4 million compared to $6.1 million for the same period in 2015. Changes in G&A expenses were mainly attributable to hiring employees to support legal, precommercial and accounting activities; legal fees to support the intellectual property strategy; and accounting fees and services related to compliance with Section 404 of the Sarbanes-Oxley Act of 2002. Net loss attributable to Coherus for first quarter of 2016 was $65.4 million or $1.67 per share compared to $40.7 million or $1.22 per share over the same period in 2015. Cash and cash equivalents totaled $179.6 million as of March 31, 2016, compared to $158.2 million as of December 31, 2015. With the receipt of $30 million milestone payment from Baxalta for completing the last patient, last visit in our CHS-0214 Phase III trials, we have approximately $210 million in pro forma cash at the end of the first quarter. Now let me turn to Denny, who will provide our product development guidance for 2016.

Thanks, John, very much. So I'm happy now to review our projections for the second half of 2016, starting with the oncology franchise and CHS-1701. Of course, as I discussed, previously, we intend to complete the follow-on PK/PD study by the end of the first half of 2016. You can expect to see that. And then we'll go ahead and file the 351(k) BLA in the U.S. directly thereafter. We also anticipate filing an MAA in the EU after the U.S. BLA. And we are currently in the midst of some regulatory discussions with the Europeans in that regard. We'll be happy to provide some additional final timing on the MAA in the next quarterly update. And as you know, the EU patent dates lag a little bit behind the U.S. patent dates. So we're now addressing this issue. Also, we will initiate certain commercial partnering discussions for ex U.S. territories with the product in the second half of 2016 consistent with previous remarks. In terms of 0214, we intend to complete 2 Phase I bridging studies in the second half of 2016, and Dr. Finck will be happy to take any questions regarding those. And then, lastly, in terms of 0214, we, of course, anticipate the filing of the MAA in conjunction with our partner, Baxalta, in late 2016. In terms of 1420, the Humira biosimilar. As I indicated, we anticipate having top line data by midyear for the ongoing Phase III psoriasis study. And as the second half of the study comprises the crossover between the products, we'll look forward to reporting on that for you in the second half of 2016. Additionally, we plan to complete an additional PK study to support certain manufacturing changes by midyear 2016 and reporting that too also. We look forward to filing the BLA for this product directly after completing the various clinical exercises and having all the data available. And then, lastly, we will continue to advance our intellectual property strategy with this product as we have discussed today. In terms of the pipeline, we remain on track to file at least one IND application for second wave biosimilar this year, and we may actually have 2 such filings in the second half of 2016 for you. So thank you very much for joining us today. I think we had a very strong executional quarter. I think that the company is doing well in all of the key areas: legal, product development and in terms of its cash position. We will be at Bank of America Merrill Lynch this week. We'll be out in various places talking to investors. If you like to see us on our various visits to New York or Boston, other places, please let us know. And with that, we're happy to take your questions.

[Operator Instructions] Our first question comes from the line of Douglas Tsao with Barclays.

This is Morgan Williams on for Doug Tsao. I was just hoping to get a little bit more color around the IPR filing against the 166 patent and not the 158, 157 formulation patents that Amgen filed against? And then, just one quick follow-up question on your intended strategy regarding enforcing your own IP estate as we go forward.

Morgan, thank you for the question. So I'll let Matt Hooper, our General Counsel, field the first one. Matt would you like to address Morgan's question vis-à-vis 157 and 158 and our issued patents?

Right. So the 157 and the 158 patents have a requirement for specific excipients for ingredients, and this -- the requirement is that you have to have a polyol or a surfactant. If you have those in there, then you would be infringing those patents, assuming they were to hold up. Now the 166 patent that we filed the IPR today does not have any specific requirement in its broadest claims to any surfactants but is essentially a claim only to a stable adalimumab formulation in which the only limitation is essentially a pH limitation. And in our petition, we present arguments as to why pH optimization was a routine initial step in any kind of rational design of a formulation well before the filing date of this patent.

Matt, could you comment to Morgan's question a little more on the significance of the allowed claims and the issued patent in the face of 157 and 158?

Sure. So if you understand that the 157 and the 158 patents require the use of surfactant and polyol, in other words, if someone is putting those ingredients into a formulation, they would be infringing those patents, assuming they hold up. Now contrast that with the patents that we're announcing today, which specifically exclude the use of surfactant and polyol, meaning that if somebody wants to develop a formulation that doesn't contain those ingredients, they will essentially be confronted with an empty set. I mean, they're blocked if they have those ingredients, and if they remove them to avoid the AbbVie patents, then they would potentially be infringing our patents. So we -- our filing of these patents reflects a strategy that we identified over 4 years ago to identify and evaluate alternative adalimumab formulation that we believe not only reflect our ability to reduce risk and have freedom to operate but also to create a potential commercial and competitive advantage vis-à-vis other biosimilars.

Our next question comes from the line of Christopher Schott with JPMorgan.

Just a couple additional IPR ones. Matt [ph] mentioned that the '166 IPR, just timelines here. Do we need to wait for an appellate verdict if you were successful before you can think about the company going to market with the biosimilar Humira? For example, with today's filings, that means, I'm doing the math right here, would be late '18 by the time this is instituted, ruled on and then appealed? Or is there a path that this could be sooner than that? My second question was on the going to the '135 IPR. I guess, if you're successful in clearing that patent, could you launch a biosimilar Humira without invalidating the method patents around other indications? So I guess, would you effectively be able to curve out the RA indication? Or do we need to think about success on many of the different indications before you could move to market?

Chris, this is Denny. Thanks for your question. Pursuant to the timing of the '166 IPR, I would point out that the first decision whether or not is undertaken by the patent office, takes about 6 months and then adjudication takes about another 12 months, let's say, as you point out. So that's like 18 months. You can line that timing up with our projected approximate filing timing towards the end of this year. I think it roughly lines up pretty much and maybe a 10- or 12-month review period with the FDA. So that timing roughly lines up in that regard. And then, I'll let Matt Hooper address your previous question about the '135 IPR.

The; 135 IPR is directed, of course, to the dosing for RA. And as you know, there are other indication and dosing patents that AbbVie has. So your question is, is if we were to successfully invalidate the '135 patent, would we consider launching for just RA and not the other indications. And I think, frankly, that's a strategic decision that is pretty far in front of us. We really don't have a point of view on that right now, but it would be a strategy that we'll unfold in the future. I think, frankly, that the success on the '135 dosing patent will not augur well for the other dosing patents just based on the fact that TNF was known to be active against these various indications, and the only question remains is whether routine optimization of dosing lends any patentability to these claims.

Our next question comes from the line of Tyler Van Buren with Cowen and Company.

Just had a couple. First on the switchover data for the 1420 trial that we'll get towards year-end. Maybe just a little more descriptions there on what exactly we will get and why it might be important. For example, maybe some updated thoughts on your conversations -- your continuing conversations with payers there? And then, for secondly on the anti-TNF partnering discussions, which should begin in a little while here. Just how are you thinking about the type and structure of a potential deal? And what are the potential needs of a partner that you would have to have to execute such a deal?

So I will first let Dr. Finck, the company's Chief Medical Officer, address the issue of the crossover design with the Humira psoriasis Phase III and why we put that in. Barbara?

Right. So the 1420 study is a 2-part study. The first part is the primary endpoint at 12 weeks. And then after that, we want to have more safety data as they continue for long-term durability. So there is a crossover. We crossed both groups over partially -- partial groups over so that we can follow subjects in the study with respect to the development of anti-drug antibodies. As you know that all the regulatory agencies are interested in immunogenicity, adalimumab is a highly immunogenic molecule. So we want to take a look at that, and we think this will go a long way having this data with respect to future filings and also with future marketing.

Tyler, to your question regarding the anti-TNF partnering, we haven't talked very much about the partners and what sorts of partners, but we'd make a few observations. As you can see, there's some derisking that is going on with that program that is, we think, very valuable to do for a partner. So we intend to get the top line data, make additional legal progress as you have seen on the formulation of intellectual property front. We'll hear about the '135 IPR a little later this month and a couple of other items like that. That takes us into potential partnership discussions late this year. We feel that partners are going to want to see the data out of a number of these studies first before they get serious in some of these other developments. And then, we're managing expectation to the first half of 2017 in terms of an actual execution of agreement. To your question about what sorts of partners we would like to have and what sorts of deal structures, I would just say that we feel that this is a very valuable asset, and we think that it is most likely, probably taken the market and maximizing the context of complementary offering. So one of the reasons why we talked a bit about our licensing strategy here is we did not want investors to believe that we were going to launch a single anti-TNF, for example, in the U.S., come up with a large sales force and high sales and marketing expenditures in that context. So we have signaled very clearly to the market that we will not do that and that we want to go ahead with partnering. That's our current plan. So stay tuned on that, I think the next stop is the data midyear on the Phase III study. We'll come back. We'll have a quarterly call directly thereafter or around that period of time, and we'll give you a little more information on the partnering and how we think about that at that point.

Our next question comes from the line of Alethia Young with Crédit Suisse.

This is Grant on for Alethia. Denny, you mentioned it, but can you talk a little bit more about your impressions from Celltrion's panel and your takeaways specifically your portfolio?

Yes, sure. Thanks for the question. We have with us today Dr. Lisa Bell, who's the company's Executive Vice President of Global Regulatory Affairs. Lisa actually attended that meeting. So I'll let Dr. Bell give her firsthand comments on the Celltrion Advisory Committee approval and her impressions. Lisa?

Sure. Thanks, Denny. So as you are aware, the Celltrion Advisory Committee occurred earlier this year. They had a very in-depth conversation about their application, and, I'd say, probably the items of note for that particular discussion were how the data that was generated in order to support extrapolation to the other indications. Importantly, there were a number of different data elements provided and presented by the company that compelled the Advisory Committee to agree that extrapolation was justified in terms of going from the clinical data that had been generated in their studies to the additional indications for which Remicade is approved. I think it was, again, a very positive indicator, if you will, for the biosimilar industry overall in terms of where this -- how this program is evolving and the likelihood of future approvals for biosimilars that have extrapolation as part of it.

Yes. Thank you, Lisa. We think it’s very, very positive for the industry and biosimilar companies. This is a complex molecule. Certainly, a top undertaking. But clearly, there's a number of forces in the environment, health-care cost, the FDA, there's a number of mega trends that you've heard us talk about before, which really are propelling the biosimilar space forward. And we think that this approval is the latest manifestation of that momentum.

Our next question comes from the line of Greg Gilbert with Deutsche Bank.

I was hoping you could share your thinking or your philosophy on partnering molecule by molecule versus perhaps forging a relationship on several products with one company?

That's a great question. Thanks for that. So, of course, as you've heard me say publicly in other forums, we would like to have or it is preferable to have one partner to take a group of 3 assets as opposed to slicing up therapeutic area by a therapeutic area. We have, for example, the MS -- we have a small molecule on MS, a legacy molecule, which is finishing up a proof-of-concept Phase IIb that you'll also hear about round about the end of this quarter, end of June-ish. Barbara will report on that. But then we have, of course, the Lucentis biosimilar, that franchise, and then the anti-TNF franchise. If we had a partner who wished to take all 3 of these and could exploit these, that, of course, would be better for us. But in lieu of that, we also would do deals therapeutic area by therapeutic area. But partnerships do represent certain amount of overhead for an organization. We all saw small organization, of course. So all in, I think you have to strike a balance here between the potential commercial maximization in each of these therapeutic areas and number of partners. So that's something that we're certainly going to keep in mind as we go forward in the second half of 2016. But I think your point's well made, and I agree with it.

[Operator Instructions] Our next question comes from the line of Douglas Tsao with Barclays.

Just maybe as a follow-up to Morgan's question in terms of your own IP, just curious if you can provide some context about how you see yourselves sort of enforcing that to protect or -- sort of protect your position in the biosimilar landscape?

Doug, I'm going to let Matt Hooper, our GC, comment on that. Matt, do you want to talk to...?

Sure. Doug, so we don't know with any certainty at this point how competitors are formulating their adalimumab formulations. So we don't know if they're including polyols or surfactants or they're not. But we've looked at some of the patent literature that provides a little bit of a window into that. And it looks like, in fact, the use of a polyol or surfactant is a fairly common choice for a Humira biosimilar. Now if you look at the AbbVie patents that block the use of those excipients, the reason we found it important to cover our formulation developments that exclude those excipients is because we recognize that it could potentially be very commercially important to be able to, from a freedom to operate standpoint, to be able to formulate a successful stable adalimumab that does not contain those ingredients. So your question, I think, is whether we would intend to enforce that IP against third parties? And the short answer is absolutely. I mean, we intend to take an aggressive posture with our IP, and that's part and parcel of our strategy.

Thanks for your question, Doug. I would -- I would also add that one of my former colleagues at Amgen said to me at one point regarding biotechnology and patents, he said, "You know, I'd always rather be the person with the patent than the person without the patent." And I think that was true then back in the '90s at Amgen, and it's -- I think it's still true today.

Okay. And then just maybe provide a little bit more clarity in terms of the filing for pegfilgrastim in Europe right now and how you're thinking about that.

Yes. We'll let Dr. Bell address that a little more. Lisa?

Sure. Thanks, Denny. So I think, Doug, just like with our ongoing negotiations with the FDA, we always seek advice from our -- from health authorities -- global health authorities to ensure that our plans align with that. And that is essentially where we feel we are right now with Europe, and we're just continuing to finalize our discussions with them so we can be well prepared for the submission and successful licensure of the future MAA.

That being said, Doug, I think that we're confident that we can get a good filing in Europe, and we can get a good approval in Europe. And so we think that the opportunity to license certain assets there is good.

And sorry, so just in terms of the conversation, just sort of focus -- because obviously, you did not do a Phase III study and get in comfort -- or [indiscernible] get in comfort with that?

Right. So as we have discussed in the past, we don't typically comment on the specifics of our regulatory interactions. But as I mentioned earlier, for all of our global health authority interactions, we want to make sure that we've had the necessary interactions to outline and obtain agreement on our plan so that way we have an understanding and we have no reason to believe that there is anything different than the understanding we have so far in terms of what will be needed for the MAA.

Yes. Doug, we did not expect to have to do a additional Phase III in patients in oncology to support European application, if that's your question.

Thank you, and I'm showing no further questions at this time. I'd like to turn the call back to Mr. Lanfear for closing remarks.

Thank you very much for joining us today. As I indicated in the opening remarks of the call, we've had a very strong quarter executionally. We've made a lot of progress in all 3 areas: intellectual property, in terms of financings and also particularly in terms of product development. We have gone ahead and executed on our milestone successfully. We have earned certain payments -- nondilutive payments from partners. And so we think we are off to a strong start in 2016, which we think was going to be a transformative year for us. We look forward to talking to all of you again on our next quarterly call. If you would like to hear from the company before that and you'd like to have a visit when we are on the East Coast or any other place, please feel free to reach out to our Investor Relation team, and we'll be happy to set up a meeting and come by and say hello. All right. Thank you all very much, and we'll see you on the next call.

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program, and you may all disconnect. Everyone, have a wonderful day.