Coherus BioSciences, Inc. (NASDAQ:CHRS)
Q2 2016 Earnings Conference Call
August 9, 2016 04:30 PM ET
Patrick O’Brien - Senior Vice President of Investor Relations
Denny Lanfear - Chairman President and Chief Executive Officer
Barbara Finck - Chief Medical Officer
Lisa Bell - Executive Vice President of Global Regulatory Affairs
Jean Viret - Chief Financial Officer
Matt Hooper - Executive Vice President and General Counsel
Mohit Bansal - Citigroup
Alethia Young - Credit Suisse
Tyler Van Buren - Cowen and Company
Douglas Tsao - Barclays
Ladies and gentlemen, thank you for standing by, and welcome to the Coherus BioSciences Second Quarter Earnings Conference Call. My name is Shawn 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, Shawn, and good afternoon, everyone. At the close of the market today, we issued our second quarter financial results press releases. 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; Michael Fleming, SVP of Commercial Strategy; and Matt Hooper, EVP and General Counsel.
Before we being our formal remarks, I’d like to remind you that we will be making forward-looking statements with respect to 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 discussion 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 statement made during this call.
I will now turn the call over to Denny.
Thank you. Thank you very, very much, Patrick. So we had a very exciting quarter and I’m happy to recap some of the key developments for you here today. First, of course, we recently released data from the 1701-05 study. This was a PK/PD study that demonstrates very good results in terms of comparability to the originator. 1701 originator were very well matched and I think you saw the data and the press release that came out and we believe this will lead to full-label extrapolation.
Additionally, as indicated in the press release this morning, we have now submitted the BLA for this product to U.S. FDA. Assuming the acceptance of this filing, we anticipate approval in Q2 2017. I would also note that given recent competitive setbacks, including complete response letters and so on, we believe that there is the potential for us to be the first approved and launched biosimilar to Neulasta in the U.S. Neulasta, as you know, is currently the largest oncology product in the U.S. and we will be providing some additional color on our commercial strategy for this program a little later in the year.
And the other thing I would like to mention upon this is we are also proceeding with our licensing for this product, as well as our oncology franchisee ex-U.S., particularly in the EU territories. And then lastly, I should also recap for you that as you are aware from our previous conversations, the manufacturing strategic relationships were in place to make up to $1 billion a year of Neulasta.
Let me turn my attention now to 1420, our adalimumab or Humira biosimilar candidate. As you know, yesterday, we released a press release announcing positive Phase 3 results in patients with psoriasis. I have with me today the company’s Chief Medical Officer, Barbara Finck, who will be happy to take questions later to provide more color on that study. We will filing the BLA and anticipate that filing be accepted sometime in the first half of 2017. We’ll just have BLA done directly or after finishing up the Phase 3 study, which we’ve talked about before is going to be completed in the second half of 2016.
We received several favorable decisions from the Patent Trial and Review Board in the U.S. instituting our IPRs on various patents of AbbVie in particular the ’135 dosing patent and the issuance of the ’680 and ’987 patents. If we see any patent that might be in a way for launch plans, we may file IPR. But I would just remind you that the company’s legal strategy is confidential, so we will not be discussing or take questions on this topic. However, I think it’s safe to say we believe that we have a strongest Patent Office of any biosimilar company currently perusing Humira biosimilars. We fully anticipate to have this product launch ready in 2018.
We registered three U.S. patents ’611, ’612 and ’880 for the formulation of adalimumab. I believe from my previous remarks, you understand that we felt that formulation is a key battleground for Humira biosimilars, so we think these are quite important in terms of launch readiness. We believe that these patents validate the company’s platform and intellectual property strategy as well as demonstrate its clinical and scientific capabilities.
And finally, regarding 1420, as you know, we will be looking to out-license this production along with 0214 in 2016 and we anticipate having a transaction completed in late, I should say first half of 2017. In terms of the status of that, we’ve just started the process of offering high level 1420 flybys to various parties now that the data is in, just as you might be interested in taking a little closer look later.
For example, we had one review of Willy, and we are very early on with everyone and we have yet not asked to begin the deal negotiations with any party, as I said we don't expect these to go on and until first half of 2017.
Turning my attention now to CHS-0214 or etanercept biosimilar, I am happy to report this program is on track. Earlier this year, we completed a randomized double-blind two-part study in patients with moderate to severe RA who had inadequate response to methotrexate were naive to biologics. We demonstrated equivalence and was measured by the primary endpoint. And the second endpoint also supported this evidence regarding the safety immunogenicity.
And then lastly pursuing to 0214, we intend to file the MAA in the second half of 2016, most likely in Q4. Now lastly, I like to turn my attention to a non-core asset CHS-131, which is a novel first-in-class breakthrough once-daily oral drug candidate for MS and it has anti-inflammatory activity in the CNS and has been demonstrated across the blood-brain barrier. You may recall that we issued a release on this and saw the positive Phase 2b results in a trial against placebo at two doses of 131.
The powerful applications of this [indiscernible] arebroad, and we are now currently understanding where it fits into the continuous care for MS and exploring relationships with potential partners. For this product on a strategic note, our intent here is to license and monetize and not to proceed with self funded Phase 3s in MS. We will also be publishing this data in abstract form at our upcoming Veterans [ph] Conference in London and the Doctor - will be viewing that in September 16, Dr. Finck will be happy to take questions regarding that.
So with that, I will now hand back over to Jean Viret, the company's Chief Financial Officer, who will comment on some of the financials. Jean?Jean Viret
Thank you, Denny. Cash and cash equivalents totaled $220.9 million as of June 30, 2016, compared to $179.6 million as of March 31, 2016. Cash used in operations was $27.4 million in the second quarter of 2016, as compared to $76.3 million in the first quarter of 2016. Excluding the $30 million milestone payment received from Baxalta, this quarter, in Q2, cash used in operations was approximately 25% less in the second quarter, compared to the first quarter of 2016. We reiterate that cash used in operations over the next two quarter to be lower than for the first quarter of this year.
Total revenue for the second quarter of 2016 was $14.1 million, as compared to $6.9 million in the second 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 four development milestone payments totaling $130 million since March 31, 2015.
Research and development expenses for the second quarter of 2016 were $65.5 million, compared to $56.9 million for the same period in 2015. Increases in R&D expenses were mainly attributable to proceeding with clinical activities associated with our Phase 3 clinical study in psoriasis for CHS-1420, advances in other product candidates in our pipeline, and hiring additional personnel to support both late-development and early-stage activities, and these were offset by a decrease in costs related to BLA-enabling studies for CHS-1701.
General and administrative expenses for the second quarter of 2016 were $11.3 million, compared to $8.8 million for the same period in 2015. Changes in G&A expenses were mainly attributable to hiring employees to support legal, pre-commercial and accounting activities, costs associated with stock options granted since the first quarter of 2015, 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 the second quarter of 2016 was $70 million, or $1.72 per share, compared to $58.8 million, or $1.56 per share, for the same period in 2015.
We will now turn the call to Q&A. Operator you may now open the call to questions.Question-and-Answer Session
[Operator Instructions] Our first question comes from the line of Chris Schott of JP Morgan. Your line is now open.
Thanks for the questions. This is [indiscernible] on for Chris. Can you talk about [indiscernible] the recently announced AbbVie Amgen litigation and can you remind us of the next, tell us on the legal front? And then based on your competitor research, what do you know about the designer competitor biosimilars and their molecules, that could affect their ultimate IP hurdles to market? Thank you.
Hi Windy [ph] this is Denny, thank you very much. Could you just repeat the second part of your question, I didn’t quite that.
Just, based on your competitor researcher market research what do you know about the design of competitor biosimilars and their molecules and how could that effect their ultimate hurdles to market?
Design of other molecules, okay. So, the company’s General Counsel is here with us today, Matt Hooper and Matt will be happy to make some brief remarks regarding your first question. Matt?
Thank you, Denny. In regards to litigation that was filed on August 4, I can tell you that none of the patterns that AbbVie has asserted against Amgen came as any surprise to us. We’ve been watching this space for nearly five years and all of the patterns that were asserted by AbbVie have been on our radar and we believe none of them would preclude us from launching our Humira biosimilar in 2018. Thanks.
Regarding your question on the design of molecules, I will just take a stab at that Windy. In the recent advisory committee there is data presented with Amgen’s Humira molecule as you know and there was also I think unanimous decision by the advisory committee for full label extrapolation. I can’t say that we have been very, very careful with the glycosylation and the engineering of our molecule. As you know, we have spent quite a bit of time with the manufacturing and the molecule itself and its attributes. So, we would expect that we would do very well in that same form with our molecule, certainly as well as Amgen. We think that we have really an excellent match on this particular molecule.
In terms of others firms and their matches on their molecules, I really can comment on that. People don’t really sell their molecular share, so it is impossible to get samples of their molecules just to look at them or to analyze them unless of course they are on the market in another area and so on. Those that are, we sometimes take a look at from here or there, but in general I think our focus is on making our molecule the most precise mere match of the originator that we can.
Sorry, this is just a follow-up, I was actually asking about how their molecular design could affect their hurdles to market in terms of IP?
How their molecular design?
This design of like, how their formulation, or how they went about…
Well formulation is of course, well that of course is a separate issue from molecular design and so on, but in terms of formulations I think that as you know we have for sometime noted that some of the key intellectual property battles for Humira was the end of formulation front. So, we are very careful there, our very first formulation pattern application included a number of embodiments, which we are now prosecuting into patterns successfully I would say. I believe that it is fair to say that Coherus is differentiated among Biosimilar developers by our focus on intellectual property and our anticipation of these kinds of legal battle.
So, I think we are very well prepared. Matt Hooper and I have looked at the formulation landscape for a number of years, five years back as he indicated. In terms of other teams, I think that if you take a look at the pattern filings from a number of the other Humira biosimilar players you will see that they appear to have formulations that are impacted either by 157 or 158, so I suppose the argument could be made that they are going to bump into those on the way, I think that that’s fairly true.
As you know where our patterns avoid 157 or 158, as I said that’s a very clear differentiator and I think it is one of the reasons we believe that we will get on the market of close approval in 2018. So, I just probably will leave it there. We try not to comment too much on other peoples legal strategies, but I do believe it is fair to say that Coherus is differentiated by the very rigorous and disciplined approach that we take intellectual property and now we integrate that into a development plan and review those development plans with the regulators with the regulators and then go forward.
Okay. Thank you.
Thank you and our next question comes from the Mohit Bansal of Citigroup. Your line is now open.
Great, thanks for taking my question. And congratulation on the progress you made this quarter. So, a quick question on Neulasta biosimilar, now that you have five, have you decided whether or not you would be involved in the patent dance or not, and do you intend to inform investors if you decide that? Thank you.
Thank you very much Mohit. I will let the company’s General Counsel, Matt Hooper fill that one. Matt?
Hi Mohit. We are not going to announce our strategy with regard to whether we are going to go into the dance or not, so this is generally consistent with our philosophy that we won’t announce our legal strategies until you see us actually executing them.
That being said Mohit, I would make two further points. The first is that the key pieces of intellectual property protecting pegfilgrastim, which is the whole of patent expires in 2015. The second point that I would make is, the company is on a record that we do not violate the various refolding and process pattern that Amgen is litigating against the other market participants. We of course are very careful about that, those are things that we were careful not to practice. So, I would just leave you with those two things. And as Matt indicated, the patent exchange process and patent dance is part and parcel of the company's legal strategy, and so we would probably just not have comments on our legal strategy for any of our products.Q - Mohit Bansal
Got it. And then if I may ask one more follow-up, what are the next steps for the IPR against one 135 patent and when will we hear more about that IPR challenge? Thank you.
I will take that one Denny. The 135 is now, the IPR is now in the trial phase and in that process we are waiting now for the submission of the patent on a statement, which is due on September 13. So the process works like this. The patent owner has an opportunity to depose our exports that we use to support our IPR and after that deposition can mount a full response to the IPR. Their initial response was filed, but now they have an opportunity as the patent owner to put in the full response.
We will have the similar opportunity to depose their experts that they use in their response and we will have an opportunity to file our own response to their response. When those two major submissions are in, then the patent office will hold our oral hearings to review the evidence. And that is all required to happen within about a year’s timeframe which would place the oral hearing sometime in the first quarter of 2017 with the final decision on the IPR in May of 2017.
Got it. Very helpful. Thank you.
The last thing that I would note on this general topic Mohit is that as you know we look forward to the institution of the 166 IPR around and I think with the first half week of November Matt, in the first week of November in 2016 also.
Our next question comes from the line of Alethia Young of Credit Suisse. Your line is now open.
Hi guys thanks for taking my question. And lots of good progress over the quarter, so congrats on that. I just wanted to ask a little bit about, like in broad strokes like I know you kind of mentioned really briefly, but just what are you kind of looking for in partners, expertise, and biosimilars, certain geographies, therapeutic skills, it is like maybe you can just give us a framework of how you're thinking about it? Thanks.A - Denny Lanfear
Thanks for the question, Alethia. I think this is, we just want to signal that we’re talking to people and we are in very early days with these things and what we've done is we are going to like to start with sort of topline flybys as I said and see who is interested. I think a lot of the big firms that are in the broadly in the anti-TNS space either with biologics or with small molecules would be fairly interested as a complementary therapeutic. I think that 1420 will fit nicely in the bag with those things and those particular biosimilars, in this case we think that’s the best way to exploit the value. So, we are relatively open-minded. It would be premature to make any comments any further than that, but I would be happy to say something more may be around Q1 or 2017 about this particular topic.
Great and then just another question on like your next sleeve, I mean is that kind of related to some of the conversations you are having or is that kind of separate and internal to like Coherus about what some of the next sleeve biosimilars will be for you guys?A - Denny Lanfear
Well as you know we have announced in an Avastin biosimilar and Neulasta biosimilar and so in the context of like routine the pegfilgrastim biosimilar, ex-US it might make sense to include follow-on biosimilars in that same oncology space such as Avastin biosimilar or Neulasta on a depending, I think that there is good interest for a number of these biosimilars and I think that Coherus is very well positioned as a premier world-class biosimilar developer. So, I think it’s fair to say that we have good interest across the portfolio for these things. I can’t really provide you any further guidance in terms of our progress and plans on that, but as I guided earlier, we will have something to say in the second half of this year about our progress on those two announced to Mohit.
Our next question comes from the line of Tyler Van Buren of Cowen and Company. Your line is now open.
Tyler Van Buren
Hi. Good afternoon, Denny and team, and congratulations on all the progress made since last quarter.
Tyler Van Buren
I had a question specifically related to the Humira biosimilar program. Clearly, you all just reported positive results from the first part of the psoriasis study, but you have the period two ongoing. I’m specifically curious about the switch portion of the study. One of your competitors just talked about potentially using a switch study like that for substitutability eventually, so curious to have you guys discuss a little bit more about that second portion of the study. What type of data we will see at your end potentially as well as more broadly your thoughts on potentially getting substitutability down the road and how long that could take? Thank you.
Thanks. Thanks for the question Tyler. I’m with Barbara Finck, company’s Chief Medical Officer, just give you the quick review here on the design of the 1420 psoriasis trial in particular, the second and third question of it and then I will let one of my other teammates talk about the substitutability question. Barbara?
Right. So, as you have noticed, we have a press release with the top line results for one of the study and we are very pleased that the study met the primary endpoint of the – meeting the PASI-75. There was no significant different and that they – confidence intervals were well within the margins that were predefined. In the second half of the study, which is ongoing, the Humira, the patients who were originally randomized to receive Humira, half of that group passes over to our 1420 molecule and that goes on for another two months. And the reason that we did that was to show that it was safe and that they would not loose efficacy as if they within a chronic patient on Humira that they could crossover safely to the biosimilar.
And so that study is ongoing, I don’t have any results report on that yet, but that was the purpose of that study – that part of the study. The important thing is that we really don’t know what the requirements are for substitution or interchangeability yet, we are waiting on the guidance from the agencies to – or from FDA to tell us really what those requirements are and we know that are a lot of companies trying to set standards of what they anticipate the agencies will require, but we actually don’t know that yet. So this is the first step to understand – but it’s safe to – for a patient who is a chronic patient on Humira to switch to biosimilar. We think that is very important data to have for a filling. But with respect to interchangeability or substitution, we don’t have any guidance yet, so we really cannot comment.
We also have company’s Executive Vice President of Global Regulatory Affairs, Dr. Lisa Bell, with us. Lisa can you give additional comments on this topic?
Yeah, hi, Tyler. As Barbara alluded to, we know that there is going to be a regulatory standard applied to the labeling for – what’s sufficient data to enable interchangeability. That’s a separate regulatory standard in terms of the approve status for biosimilars. Our immediate goal right now is focus on getting biosimilarity in terms of this particular program. And as the agency comes forward with their own guidance on what’s needed, which – honestly, we don’t know if it’s going to align with the data that’s been presented because people are taking actions and we – there is not really yet a guidance to refer back to on what’s the minimal or the feasible amount of data that’s needed to support this.
Tyler Van Buren
I guess I’m just kind of surprised that they haven’t come out with guidance yet given how rapidly your programs advancing as well as a couple of others that are behind you all or one in front. Do you have any idea on kind of the timelines with respect to the agency, do they have – are there any upcoming events either this year or next year or is it still pretty vague on your side?
Lisa, would you go ahead?
Yeah, so the agency has a list that they publish every year about what’s on their dock in terms of guidance documents that they are planning to issue. They have by their admission a process that they go through that involved with the writing, the review and broader acceptance getting that input internally on any guidance content that’s going to be issued. And this one, as you can imagine, is one that they really want to be thoughtful about because they have implications. So I think it’s prefect given the time to think through what is the right amount of data to inform physicians, to inform patients and to make sure that the playing field is level in terms of what scientifically rigorous and robust and defensible. So I would expect that according to their timeline, they are going to try their best to hit the sphere and we just need to give them the time to do that.
Tyler Van Buren
Great. Thanks, everyone.
[Operator Instructions] And our next question comes from the line of Douglas Tsao of Barclays. Your line is now open.
Hi. Thanks for taking the questions. Denny, I know you talked about the filing of the IND for the – one of the two products in the back half of the year. Just curious what is the lens that you are sort of determining? Is it more of a commercial? Or is it simply a stage of development that you are going to decide which candidates are going to moving ahead in development?
I’m sorry, Doug, which products I move ahead into development is…?
In terms of the way two products – I mean are you thinking about things from a commercial standpoint now or is it simply which products are simply ready to move into clinical development.
I think we’ve discussed this previously as you know. I think that we are fairly nuance in how we select products to go forward with. There is a combination of things that you have to look at. The technical feasibility is one; the clinical feasibility is another; whether or not there is a relatively stable market for the product or is it some paradigm shift by new technology that’s coming into some of these products; whether it’s partnerable and how the payors feel; a whole number of consideration that we take look at. In terms of Avastin biosimilar, we thought that that fit very, very well with our focus in U.S. oncology. That was something when we talk to key opinion leaders and payors and other entities in that space, they all had a fair amount of enthusiasm for us to pursue, so it wouldn’t be surprising for us to continue to enhance our oncology portfolio with adalimumab. I think I previously commented on our Lucentis biosimilar, we are approached by a number of folks for ophthalmology and to develop products there. So that also plays a key role in things.
So I think that we are very, very focused on the endgame when we select these products and we have to go forward with them, we are fairly certain that we are going to carry them through. Now the other key question of course is just when in development of products you choose to license. And there’s arguments made for licensing early and there’s arguments made for licensing a little later. With 0214, we are able to license that product with very nice upfront from Baxter as you recall, prior even to the readout of the Phase 1 data. So you can either do it before that or after that, when it’s phase 3 ready. In general, I would say we would probably do licenses when products are more Phase 3 ready for these. Certainly, that’s not the hard and fast rule.
And then in terms of – you’d indicated that you’d potentially been interested in the MS data of the – for the biosimilar hinging on the data for CHS-131, now that we’ve seen that. What’s your updated thoughts there?
Great question. So we are currently taking a very careful look at the mechanism of action for INT-131. This is a CNS anti-inflammatory, which is quite novel. So we are engaged with number of KOLs over that MoA and the complementarity of it for other existing therapeutics in the field. And that will drive our decision in terms of our own portfolio around MS. But I think it’s important to note that this product that we believe is anti-inflammatory without being immune suppressive that may have bought application in the CNS. So I would just ask for a little patience while we work through the data, which we’ve just provided – top line data, we are still going to submit, go through the data and we will probably have a little more say about this on the next call.
Okay. Great. Thank you very much.
With no additional questions, I will now turn the call back over to Mr. Lanfear for closing comments.
Thank you all for joining us today. And thank you for your interest in Coherus. I think we’ve had a very good quarter here. As you can see, the company has continued to focus very, very sharply on execution across the product portfolio through Q1 and Q2. We have a number of positive readouts in terms of our Phase 3s. Certainly, the two 0214 readouts in psoriasis or RA; 1420 in terms of psoriasis; we have a two successful BLA-enabling studies now with 1701; the PK/PD study, which really the data came out very, very nice; and lastly, the immunogenicity with 1701 and now the BLA. So I want to thank my team for their efforts here as lot of folks are pulling very hard on their roles [ph] here at Coherus. We look forward to continue strong execution through the reminder of the year and we look forward to giving you all another update on the next quarterly call. Thank you very much.
Ladies and gentlemen, thank you for participating in today’s conference. This does conclude today’s program. You may all disconnect. Everyone have a great day.
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