Coherus Oncology Inc (CHRS) 2017 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Coherus Biosciences first quarter earnings conference call. My name is Iola, and I will be your conference operator for the call today. (Operator Instructions) 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, Iola, and good afternoon, everyone. After close of market today, 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 begin 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 on file 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 will review progress on our lead onc program, CHS-1701. We will 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 pipelines, CHS-0214, our etanercept biosimilar; CHS-131, our small molecule for MS and so on; and then we'll 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 483 observations are deemed to be successfully addressed. Further, I can let you know that we have had GMP inspections of our Redwood Shores headquarters, and the result of that was no 483 observations.

Finally, we have also had various inspections at the clinical sites involved in the 1701 program with 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 previously announced, we've completed the initial phase of such with Amgen pertaining to the intellectual property surrounding Neulasta and Coherus Biosciences' pegfilgrastim. Two of the patents originally listed by Amgen in the process have resulted and reached agreement on a single patent for potential litigation. That is U.S. 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 salts and hydrophobic interaction 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 May 11th or otherwise lose the right for preliminary junction, so on. So that is something we'll be happy to -- again, to discuss during the Q&A.

In terms of the Supreme Court and 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 observed the relevant arguments at the Supreme Court in the case of Sandoz versus Amgen. As you know, this decision is anticipated in late June. And we would just add that until the Supreme Court decides otherwise, we will, of course, observe the current BPCI interpretation, that is the 180-day waiting period. We will not handicap which way we think this decision will go, but we'll be 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 is. With approximately 30 days remaining before the BsUFA action date, however, it 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, an Ad Comm is not a requirement for our biosimilar in particular, as has been evidenced recently with other products. Regardless, the company has continued to prepare for potential FDA Advisory Committee, and we'll 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 100 -- the Day 120 questions. In our view, these questions were 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 us today, and during Q&A, please don't forget 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 actions. We continue to target a second half of 2017 launch, as previously guided.

Now let me talk a little bit about CHS-1420, the company's HUMIRA biosimilar. As you know, the -- 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 a final PTAB adjudication of the 135 patent on or before May 17, 2017, perhaps in the next week or so. The oral arguments occurred February 16, 2017, and in our view, those arguments and the judges' 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 4 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 will continue to guide towards 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 completions. We are targeting license agreement in second half of 2017 for this product.

Finally, let me recap our partnering objectives. Firstly, in terms of EU with 1701, we continue with 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 the partnering 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 discussions over to Dr. Jean Viret, the company's Chief Financial Officer.

Thank you, Denny. Cash, cash equivalents, short-term investments and marketable securities total $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 with $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 was 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 over 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 over the same period in 2016.

We'll now turn the call to Q&A. Operator, you may open the call for questions.

(Operator Instructions) Our first question is from Ian Somaiya with BMO Capital.

I had 2. First, on the manufacturing side, just as it relates to 1701. Can you just confirm the FDA's green light of the bulk and the fill and finish for that product? And then I just had one other question.

Yes. So thank you very much for the question, Ian. I'm going to have Vince Anicetti, the company's Executive Vice President of Global Quality, reply to that. Vince?

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

Okay. And just the -- one other question I had was on the Day 120 questions. I don't know if you could sort of speak to the nature of the questions, and whether you think there'll be any major sort of data sets that might be required to answer any of those questions.

Thanks, Ethan (sic - Ian). I'll turn that over to Dr. Lisa Bell, our Global Head of Regulatory Affairs. Dr. Bell?

So in terms of the questions we've been receiving, the questions are reasonable. They -- we've actually been addressing them in a pretty fast time frame, as quickly as they've asked them -- asked us to provide them. Right now, we have no expectation of any questions that would require an additional data set to be provided.

Okay. And if I could just ask one final question, completely unrelated to 1701 or the 2 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. The -- 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.

Great. I have one question regarding the Onpro device. And given that the use of Onpro has been increasing, to what extent do you think it is practice changing for doctors as well as the 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 Onpro as cannibalizing the same such market. This primarily is due, in our view, to a 2% or 3% 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 are 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 Onpro adoption is quite reversible upon various contracting approaches, and we would look forward to do that. That being said, as you also know, we have initiated development of our own device. As we believe there's about a 15%-or-so actual part of the market that benefits by remote administration, and we don't want to leave any market segment unaddressed.

Our next question is from Chris Schott with JPMorgan.

Great, just a couple here. Maybe first just coming back to 1701. And I appreciate all the comments on the call and the color. It's just, at this point, I know there is no panel, but is there anything in the review process, thus far, that's either been surprising or suggests the review is not progressing on track?

Yes. Thanks for that comment, Chris. I'll let Dr. Bell address that. Lisa, would you care to offer what comment you can?

Sure, Chris, I mean, as far as the review has been going, I'd say it's ongoing, and just reflects the standard process for a biosimilar review. And maybe it's 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, a different review paradigm. And what that means is for a new drug a few years ago, they moved to a review paradigm that involves preset 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 we'll be moving to next year with BsUFA II. And while this sounds like a level of detail, it's 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, right?

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

Was that helpful, Chris?

Yes, very much so.

Yes, (inaudible) 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 positive light. 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 really provide you on that.

Okay, great. And then just a couple other quick ones, just so I'm clear on this. With the patent dance in the '707 patent, can you, just so I'm clear on this, talk through the process from here? What do you need to do to the extent that Amgen does sue on this -- I mean, I think you've got 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 to launch this drug and any slowdown that could involve.

Sure. 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 has to the 11th, which is this Thursday, to file litigation under this patent, as agreed in the patent dance and as required. If they do not, then they 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'll 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.

Yes, go ahead, Chris.

I was just going to ask a final question, but if -- I didn't want to interrupt if you're continuing there.

No, we're okay. Go ahead.

Okay. And so my final question's just maybe shifting gears to 1420. Just to the extent that the '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 time frame to get to market? I know you have the PK study on the alternative formulation to '166 that's starting later this year, but just what other key things do we need to be watching from your perspective to hit those time lines?

Yes, as we've indicated earlier, the strategy to move forward is comprised of 3 key parts. First of all, you have to have a formulation, which is robust and efficacious and keeps the protein in solution and without changes and stable, et cetera. The second is you need a clinical program to show that you don't have any 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 formulations is move forward with additional formulations, which we've talked about. We have further disclosed that we intend to do pharmacokinetic studies in the second half of 2017. And then I think that you can assume that we believe our formulations were all quite robust.

So I would stop there in terms of describing our ultimate strategy for the formulations primarily for competitive reasons, but I would point out to you that we think all 3 of those parts are very, very important.

Okay, I do have an additional comment; I wanted just to loop back just briefly. Ian asked a question at the beginning regarding the fill and finish and any inspection of the fill and finish or any concerns we might have about that. And I know that others in the field have, from time to time, had fill and finish problems in various facilities with the FDA. And I'll just ask Vince Anicetti to make any comments regarding our -- the fill and finish inspections and how we feel about that. Vince?

Yes, thank you. We did -- we had a preapproval inspection at our fill finish site in January of this year. It lasted for 5 days with a number of FDA inspectors. We received a few 483 observations. At the end of this, all of these I would characterize as nonproduct-related and relatively routine related to technique at the site. The sites responded to all of those. We believe we have meaningful corrective actions, and so we think that that inspection is successfully concluded.

So no problems or issues on the fill and finish front in our view, all right?

Our next question is from Alethia Young with Credit Suisse.

Maybe 2 for me. One, I guess, just maybe talk a little 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 like as relating to the IPR. If you guys -- if your IPR is not invalidated, do you think that Boehringer Ingelheim's would be? Are there any similarities or differences between the 2 IPRs?

Yes, so thank you, Alethia, for your question. I'll first tee that up, and then I'll let Matt add a little more to the Boehringer Ingelheim differences and arguments. And then I'll let Dr. Bell talk a little bit about the Epo Advisory Committee. But let me first say that the -- there are 2 cases on '135, and so there's actually 2 opportunities to usurp that patent.

As I indicated earlier, we felt that most of the oral arguments were very, very consistent with the judges' initial questions and how they interpreted, for example, the claims construction in [a prior arg], which I think are the 2 key issues here. I'll let Matt Hooper talk a little bit more about the Boehringer Ingelheim IPR. Matt, any observations you can give?

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 reach -- have an invalidation of the '135, in which case, that would make the subsequent decision on the BI IPR moot.

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 there -- the panel may see. We see that as unlikely. I think the panel is -- the 2 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 2 separate IPRs.

And I'm going to let Dr. Bell address your issue pursuant to the Epogen biosimilar Ad Comm.

Yes, Alethia. So we're aware of the Epo Ad Comm that's coming up. I mean, I think that, again, the facts that the FDA chooses to take the option to call an Advisory Committee for Epo is absolutely their prerogative. As Denny mentioned earlier, the need for a biosimilar 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 the approvability of our application.

Yes. The other comments I would make, Alethia, is Epogen is a very, very complex molecule. In terms of glycosylated molecules, 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 2 types of molecules. One's an E. coli molecule that's pegylated and one is a CHO molecule that's highly glycosylated and very sensitive.

And can I just clarify one thing on the fill finish? So all the issues related to the fill finish are now resolved to your knowledge? Or are they not? I just didn't catch it on the question.

All of the issues regarding the fill 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.

I think it's -- Alethia, I think it's fair to say that 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.

If I could just go back to the 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.

I can 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 Mike will be happy to tell you a little bit about some of the launch preparations and his team. Michael?

Yes. Thanks, Denny. So as Denny had said earlier, we're guiding The Street to a potential launch in the second half of '17, and we're preparing our commercial organization accordingly. We're building our commercial capabilities, our marketing, sales and market access capabilities to address the -- a 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 is in hand, Michael will be happy to provide you some additional detail and color around the launch and the strategy.

Our next question is from Morgan Williams with Barclays.

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 slides make it seem like it's in the earlier half of the year. Just thinking about the bridging study that you're doing to the new formulation, does this then 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.

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 for the file on that and second half for the PK study. Lisa, do you have some additional comments (inaudible)?

Sure. So 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, right? And the -- as you know, the -- as Denny just mentioned, the 1420 application is targeted for second -- Q2 -- end of Q2 this year. That one will be going in before BsUFA II is implemented, and then -- so it'll 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. So for anything like a postapproval change, it's just a standard review. There's no difference between a new molecular entity and a biosimilar.

So I guess I'm -- so -- sorry, so 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 in 2Q, but then you're doing this bioequivalent-type study at this -- at the second half of the year.

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

Okay, that makes sense. And then, just my second question. So just 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, both -- that's a great question, of course. The -- 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, EU rights, China, Japan and all the major territories with the exception of ex Brazil, LatAm. Same thing with 0214.

So we think further that there is synergy between these 2 assets in terms of the treatment paradigm and the implied clinical interchangeability of the patients. There are various comps that one could look at in terms of this, but our desire, as we have said previously, is to retain approximately a 50% value downstream backside and pull the remaining value forward.

We look to these assets to provide additional nondilutive 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 our process and then be happy to give you some additional guidance at that point.

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

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 does a federal judge let you launch if you can't indemnify on damages? I'm just thinking about your balance sheet and potential damages you would incur.

Well, Ken, you know of course, that 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 -- 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, the refolding patent and others.

You may recall that 1.5 years ago, when the refolding and these other patents came up, we guided The Street towards noninfringement and nonuse 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 with the merits, the remainder of that analysis, I think, require -- 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 assertive. 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 Mike Ulz with Baird.

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 types of questions you're getting or there -- or have there been any noticeable differences there?

Just let me clarify. Is there -- is your question that EMA and FDA have different steps of questions or different approaches?

Kind of (inaudible) yes.

Okay. I get -- just -- Lisa, what can we say if anything about this?

I mean, without getting into specifics, I'd say, first of all, these 2 agencies are both highly rigorously -- 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 overlaps somatically, 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's come through has been reasonable and, I think, within our expectations.

Our next question is from Umer Raffat with Evercore ISI.

Denny, what would FDA need to establish the stability of your nonbuffer formulation? And how different is your pH in the buffer versus your own nonbuffer formulation one?

And the second one, this -- you may have commented on this. I'm still ramping up. The formulation that you're filing right now in HUMIRA, the biosimilar HUMIRA, my question is on 3 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?

All right. Well, let me see. Let's start with buffers and protein stability 101. So for any given protein, there is a particular pH that the protein likes to be in. This is determined primarily off the primary sequence of the protein. That is the amino acids that comprise the 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 at the same formulation pH.

Now pursuant to the issue of buffers and nonbuffers. So buffers are a way of stabilizing a pH at a certain point. Now some -- at some protein concentration, that is low protein concentrations, buffers are required to prevent pH drip. However, at 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, of course, have not disclosed that for competitive reasons.

But fourth, I would just ?- I'd 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 it's fair to say the company has spent a fair amount of time in the development of novel formulation approaches, particularly with respect to HUMIRA biosimilars.

The company has filed a number of patents, and you will see continued patent activity from us. Now 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 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 ones, but I can direct you to our patent filings or provide those to you.

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

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.

Doug, thanks. Dr. Bell would be happy to offer you a plan. Lisa?

Doug, yes. So as part of like our -- 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 there. So I would just characterize this as a standard meeting.

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 have 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.