Coherus Oncology Inc (CHRS) 2016 Q1 法說會逐字稿

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.

Thank you, Kelly. Good afternoon. I am 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 investors 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 it's CHS-1701, CHS-0214, CHS-1420, CHS-5217 and CHS-3351, biosimilar drug candidates, complete reaching studies for CHS-0214, complete its follow-on PKPD's study for CHS-1701, filed VLAs for CHS-1701 and CHS-1420 in the US, filed an MMA for CHS-014u, filed one IMV on a second wave biosimilar pipeline candidate, enter into collaboration for CHS-1701 commercialization XUS, and advance its intellectual strategy for CHS-1420, including with respect to the issuance to Coherus of three US patents on adding the above formulations.

As such, we are subject to the risks and uncertainties that we discussed in detail in our documents filed with the SEC, specifically Coherus' annual report on form 10-K 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, Mike will cover our recent progress on incrementing our IT 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 had a very strong quarter here in Q1 2016. The Company has been particularly focused, as you know, on execution with our programs and 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 NT/TF and up 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 de-risking 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 as another IPR.

In terms of the clinical front, we have advanced all three wave-one assets towards our regulatory filings very successfully, and the pipeline of course, there's two programs there, which we'll talk about.

In terms of the intellectual property front, specifically in terms of, once again, HUMIRA and those issues, we have for formulation patents that are about to issue, and the IPRs I have previously alluded to. This of course is the 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 non-dilutive financing admitting a Baxalta milestone -- performance milestone -- which we will talk about. Lastly, I think it's important in the context of the biosimilar business to cite the progress with the regulators, particularly here in the US.

We were very happy to see last quarter the first approval of a complex di-costilative molecule, Celltrion's Remsima. We think this is a very important development for the biosimilar industry, and it shows the FDA is very committed to the pathway, the pathway can be navigated successfully, and particularly, full-label extrapolations can be earned in terms of these complex molecules, which we of course plan our NT/TF assets.

Now let me first start out here with our oncology franchise. CHS-1701, our pegfilgrastim biosmilar. As you know last quarter, we announced that we had successfully met the co-primary endpoints of the BLA-enabling immunogenicity study in healthy volunteers. This was a study that was initiated in 2015 and then completed in February of 2016.

Aside from that, we have also initiated, as you know, a follow-on pharmacokinetic and pharmacodynamic study in January 2016 to support the BLA application. We have not changed our prior guidance regarding the expected topline data timing, which we believe will happen at the last half -- I'm sorry the last part of this quarter and this first half of 2016.

Additionally, in terms of the 1701 program, we have now successfully completed the manufacturing campaign and process qualification lots in support of the BLA. I turn my attention now to the immunology and NT/TF therapeutic franchise and CHS-0214, our Enbrel biosimilar.

As you know, we've successfully met the primary endpoint of the first phase 3 in rheumatoid arthritis, and we announced that in January 2016. We then also subsequently announced the successful psoriasis phase 3 study. This is CHS-0214-04, which will support the BLA. We have also gone on, as I indicated a moment ago, to earn the performance milestone for last patient, last visit for both those two studies from our partner Baxalta of 30 million.

Now to talk a little bit about the 1420, Adalimumab Humara biosimilar program and how that's faring. We have now completed enrollment of the phase 3 psoriasis study. This happened in March 2016. I wanted to let you know that we expect topline data from the psoriasis study in midyear, and Dr. Finck, the Company's Chief Medical Officer, is here to take your questions pursuant to this study.

Now this study includes in its second half a switch over to the adalimumab reginator, as you've seen we talk about in some of the investor meetings. That will happen in the second half of this year. So we look forward to concluding the switch-over part of the study in the second half, and then of course filing the EPLA for this directly thereafter. Now before I hand things over to Matt Hooper, the Company's General Counsel, I want to make just a few remarks about the intellectual property side of things here with 1420.

As you know, IP is a key pillar is the Coherus Biosimilar platform, and we believe that success with IP is just as important as success with regulatory approvals and commercial strategies. To date, the Company has filed a number of patents for anti-TNF formulations, and we're happy to announce today the first allowance of some of these patents, which Matt will talk about a little more.

We continue to have very strong executional progress in the context of our intellectual property development in our risk reduction strategy. We continue to see IPRs as a tool to be judiciously deployed for addressing IP issues, and as you know, we filed the first IPR on the 135 patent in November, and we expect a decision here probably about the third week of this month.

Now I will turn this over to Matt, the Company's General Counsel, to make some remarks about our IP developments and strategy. Matt?

Thanks, Denny. Today, Coherus filed its petition for an inter-parties review or IPR of AbbVie's US patent 9114166. Generally speaking, the 166 patent is directed to a buffered isotonic and pH controlled formulation of the adalimumab protein at a concentration of 50 mg per ml, and it's suitable for subcutaneous injection.

The petition that we put in argues that a pH-controlled adalimumab formulation as 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 a declaration from Dr. Mark Manning, who co-authored and co-edited 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 knowledge and the ability to do exactly that as part of a rational and well understood approach to protein formulation that was already clearly established in the art. In subsidiary claims of the patent, 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 our clearly taught how to concentrate a protein 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 would like to turn to the patent issuances that we are announcing today. United States patent trademark notified Coherus recently that three 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, and they're known as polyol and surfactants.

For example, our US patent 9340611 concerns buffer formulation that can be formulated without polyol. Our US patent 9340612 concerns buffered formulations that can be formulated in the absence of both polyol and surfactant. And finally, the third patent that we will issue is 9346888, and that is directed to a buffered formulation prepared without surfactant. We have other formulation patents pending both in the US and abroad.

The intellectual property considerations are one of the four pillars of our biosimilar platform. The new patents that will issue to us demonstrate the fruits of our formulation developed strategy conceived early on, in which we recognized the potential importance of evaluating and patenting a variety of alternative HUMIRA formulation embodiments.

We believed 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 two products in the pipeline, CHS-5217, and Avastin biosimilar, and CHS-3351 the Lucentis biosimilar. Consistent with our previous guidance, we'll have more to say about the pipelines move forward, but you may recall that we intend to file at least one if not two INDs as we go forward with these products.

I would now like to pass the call back over to Jean, who will provide some financial highlights for 2016 Q1. Jean?

Thank you, Denny. I will now review financial highlights for our 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 increase for commission in Baxalta collaboration revenue as a result of receiving three development milestone payments totalling $100 million in 2015.

Research and development expenses for the first quarter 2016 was $65.3 million, compared to $36.5 million for the same period in 2015. Increases in R&D expenses were mainly attributable to having four ongoing phase 3 and the VLA-enabling studies for CHS-0214, CHS-1420, and CHS-1701 in 2016, compared to just two late stage studies that were ongoing in 2015. Proceeding with pre-clinical activities associated with early-stage pipeline and hiring additional personnel to support late development and early-stage activities.

This past quarter represents the high point of R&D spending in 2016, and we project a quarter-to-quarter decline in R&D spending for the rest of the year as we complete (technical difficulties). 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 pre-commercial and accounting activities, legal fees to support the intellectual property strategy and accounting fees and services related to compliance with Section 404 of the Sabranes-Oxley Act of 2002.

Net loss attributable to KRS for the first-quarter of 2016 was $65.4 million or $1.67 per share, compared to $40.7 million or $1.22 per share for 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 3 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, Jean, 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 it PK PD study by the end of the first half of 2016, you can expect to see that. And then we will go ahead and file for the 51 KBLA in the US directly thereafter.

We also anticipate filing an MAA in the EU after the US 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 our next quarterly update, and as you know the EU patent dates lag a little bit behind the US patent dates, so we're now addressing this issue.

Also we, will initiate certain commercial partnering discussions for the ex-US territories with the product in the second half of 2016, consistent with previous remarks.

In terms of 0214, we intend to complete two phase 1 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 4020, the HUMIRA biosimilar, as I indicated we anticipated having topline data by midyear for the ongoing phase 3 psoriasis study. And as the second half of this study comprises a crossover between the products, we also 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 to you also. We look forward to filing the BLA for this product directly after completing the various clinical exercises and having all of 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 a second-wave biosimilar this year, and we may actually have two 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 a terms of its cash position.

We'll be at the Bank of America Merrill Lynch this week. We'll be out in various places, talking to investors, if you'd like to see us, on our various visits to New York or Boston or other places, please let us know. And with that we're happy to take your questions.

(Operator Instructions)

Douglas Tsao, Barclays.

Hello, 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 formulations 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.

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

Right, so the 157 and the 158 patents have a requirement for specific excipients or ingredient, and the requirements 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 would hold up.

Now the 166 patent we filed the IPR today does not have any specific requirement in its broadest claims to any surfactants, but it 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. If you understanding 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 are 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. They are 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, our filing of these patents reflects a strategy that we identified over four years ago to identify and evaluate alternative adalimumab formulations 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-a-vis other biosimilars.

Okay, great. Thank you, and congratulations on the progress.

Thank you, Morgan.

Chris Schott, JPMorgan.

Great, thanks for the questions. Just a couple additional IPR ones. I think you mentioned that the 166 IPR, just timelines here, do we need to wait for an appellate verdict if you are successful before you think about the Company going to market with a biosimilar HUMIRA? So for example, with today's filing, that mean -- I'm doing the math right here -- it would be late 2018 by the time this is instituted, ruled on, 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 are 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 carve the RA indication, or do we need think about success and many of the different indications before you can move to market? Thanks very much.

Hello, Chris, this is Denny. Thanks for your question. Pursuant to the timing of the 166 IPR, I would point out that the first decision of whether or not is undertaken by the patent office, takes about six 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.

The135 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, 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 will unfold in the future.

I think frankly that the success on the 135 dosing patent will not auger 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.

Thank you very much.

Thanks, Chris.

Tyler Van Buren, Cowen and Company.

Thanks for taking my questions. I just had a couple. First on the switchover data for the 1420 trial that we will 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 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? Thanks.

Thanks, Tyler. 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 3 and why we put that in. Barbara?

Right. So the 1420 study is a two-part study. The first part is the primary endpoint at 12 weeks. And then after that we want to have more safety data and to continue for long-term durability. So there is a crossover. We'll cross both groups over, partial groups over, so that we can follow subjects in the study with respect to the development of anti-drug antibodies.

As you know, all of 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.

To your question regarding the anti-TNF partnering. We haven't talked very much about the partners and what sorts of partners. But we would make a few observations.

As you can see, there is some de-risking that is going on with that program. That is we think very valuable to do for a partner. So we intend to the topline data, make additional legal progress, as you have seen on the formulation intellectual property front.

We'll hear about the 135 IPR a little bit later this month, and a couple of other items like that. That takes us into potential partnership discussions late this year. We feel the partners are going to want to see the data out of a number of the studies first before they get serious in some of these other developments. And then we're managing expectations 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 it is most likely probably taken to market and maximizing the context of complimentary offerings. 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 US, come up with a large sale force and hi-sell to marketing expenditures in that context.

So we have signaled very clearly to the markets that we will not do that and that we want to go ahead with partnering. That is our current plan. Stay tuned on that, I think the next stop is the data midyear on the phase 3 study. We'll come back, we'll have a quarterly call directly thereafter or around that period of time, and we will give you a little more information on partnering and how we think about that at that point.

Okay. That is very helpful. Thanks again.

Alethia Young, Credit Suisse.

Hello, this is Grant on for Alethia. Thank you very much for the question. Denny, you mentioned it, but could you talk a little bit more about your impressions from Celltrion's panel, and your take-aways specifically to our portfolio? Thank you very much.

Thanks for the question. We have with us Dr. Lisa Bell, who is the Company's Executive Vice President of Global Regulatory Affairs. Lisa actually attended that meeting. So I will let Dr. Bell give her first-hand comments on the Celltrion advisory committee's 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 would 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 was 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 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.

Thank you, Lisa. We think it is very, very positive for the industry and biosimilar companies. This is a complex molecule. It is certainly a tough undertaking, but clearly there is a number of forces in the environment, healthcare costs, the FDA. There is a number of mega-trends, as you've heard us talk about before, which really are propelling the biosimilar space forward. We think that this approval is the latest manifestation of that momentum.

Perfect. Thank you.

Greg Gilbert, 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?

Hello. That is a great question. Thanks for that. So of course, as you have 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 three assets as opposed to slicing off therapeutic area by therapeutic area.

We have for example the -- we have small molecule and MSO legacy molecule, which is finishing up a proof of concept phase 2b, that you'll hear about, around about the end of this quarter, end of June-ish And have Barbara 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 three of these and could exploit these, that of course would be better for us. But in lieu of that, we would also do deals therapeutic area by therapeutic area.

But partnerships do represent a certain amount of overhead, foreign organization. We are a 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 is well made, and I agree with it.

Thanks.

(Operator Instructions)

Douglas Tsao, Barclays.

Hello, good afternoon, thanks for taking the questions. Just maybe as a follow-up to Morgan's question in terms of your own IP, just curious if you could provide some context about how you see yourself sort of enforcing that to protect, or sort of protect your position in the biosimilar landscape.

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

Sure. Thanks Doug. So we don't know with any certainty at this point how competitors are formulating their Adalimumab formulations. We do not know if they are 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 recognized 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. We intend to take an aggressive posture with our IP, and that is part and parcel of our strategy.

Thanks for your question, Doug. I would just 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 would 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 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 are thinking about that.

Yes, we will let Dr. Bell address that a little bit more. Lisa?

Sure. Thanks, Denny. So I think, Doug, just like with our ongoing negotiations with the FDA, we always seek advice from our 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 are just continuing to finalize our discussions with them so we can be well prepared for the submission and for the full licensure of a future MAA.

That being said, Doug, I think that we are 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 so just in terms of the conversation, just sort of a focus, because obviously you did not do a phase 3 study and get in comfort, or then get in comfort with that?

Right, so as we've 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 have had the necessary interactions to outline and obtain agreement on our plans, so that way we have an understanding and we have no reason to believe that there is anything different than the understanding that we have so far, in terms of what will be needed for the MAA.

Doug, we do not expect to have to do an additional phase 3 inpatients in oncology to support European application, if that is your question.

Great. Thank you very much.

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

Thank you very much for joining us today. As I indicated in our opening remarks of the call, we've had a very strong quarter executionally. We made a lot of progress in all three areas: intellectual property, in terms of financings and also particularly in terms of product development.

We've gone ahead and executed on our milestones successfully. We have earned certain payments, non-dilutive payments from partners. And so we think we are off to a strong start in 2016 which we think is 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 in any other place, please feel free to reach out to our investor relations team and we will be happy to set up a meeting and come by and say hello. All right? Thank you all very much, and we will 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.