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Coherus Oncology, Inc. (CHRS)

Q3 2016 Earnings Call· Wed, Nov 9, 2016

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Coherus BioSciences Third Quarter Earnings Conference Call. My name is Donavan 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. Patrick O’Brien: Thank you, Donavan, and good afternoon, everyone. After close of market today, we issued our third quarter financial results press releases. This press 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, our Chief Medical Officer who is dialed in remotely; Lisa Bell, EVP of Global Regulatory Affairs; Jean Viret, our CFO; Matt Hooper, our EVP and General Counsel and Michael Fleming, our SVP of Commercial Strategy.. 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 description of these risks can be found on our most recent Form 10-Q and filed with the SEC. In addition, Coherus BioSciences does not undertake any obligation to update any forward-looking statement made during this call. I'd now like to turn the call over to Denny.

Denny Lanfear

President

Thank you, Patrick, and thank you for joining us today on our call. We will review the company's first wave of products CHS-1420, our adalimumab biosimilar, CHS-0214, our etanercept Enbrel biosimilar, CHS-1701, the company's pegfilgrastim biosimilar; in that case also regarding 1701 we will also provide some color on the company's progress in terms of the commercialization of this product. And then we will also provide you an update on licensing. In terms of CHS-1420 and in terms of Q3 event for our Humira biosimilar, we reported top line results from the ongoing Phase 3 clinical study CHS-1420-02 in psoriasis with 545 patients which are randomized for the study. As you recall, all primary endpoints demonstrating similarity between 1420 and Humira with respect to percentage of subjects achieving 75% improvement in psoriasis area and severity index the PASI-75 score at week 12 were achieved. The 95%confidence intervals for the difference between the groups fell well within the prespecified margin. And both CHS-1420 and Humira were similarly well tolerated with similar safety profiles in this study. Secondly, the company was awarded a fourth US patent, 9,382,317 on formulations excluding surfactant and polyol. And company's general counsel, Matt Hooper is available during the Q&A for additional questions regarding this particular patent. In terms of subsequent events and in fact in the product, let me just discuss the 166 developments of earlier this week a bit more. First of all, as previously announced, the company received the decision denying institution for IPR pursuant to the AbbVie 166 formulation patent. And while we are disappointed with this development, I'd like to make the following statements regarding our formulation efforts and our intellectual property position. First, we believe the key scientific arguments may not have been appreciated or may have been overlooked by the panel.…

Jean Viret

CFO

Thank you, Denny. Cash and cash equivalents totaled $159.7 million as of September 30, 2016, compared to $220.9 million as of June 30, 2016. Cash used in operations was $61.2 million in the third quarter of 2016, as compared to $76.3 million in the first quarter of 2016. Cash used in operations was approximately 20% less in the third quarter, compared to the first quarter of 2016 as previously guided. . Total revenue for the third quarter of 2016 was $162.8 million, as compared to $7.2 million in the third quarter of 2016. Total revenue for nine months ended September 30, 2016 was $189.3 million as compared to $19.8 million for the same period in 2015. The increase over the same period in 2015 was due to increased recognition of collaboration revenue as a result of regaining the full development and commercial rights for CHS-0214 from Shire in Europe, Canada, Brazil, the Middle East and certain other territories. Research and development expenses for the third quarter of 2016 were $64.6 million, compared to $68.2 million for the same period in 2015. R&D expenses for nine months ended September 30, 2016 were $195.4 million, as compared to $161.6 million over same period in 2015. The decrease in R&D expenses in the third quarter over the same period in 2015 was mainly due to the completion of BLA-enabling studies for CHS-1701 and the completion of two Phase 3 studies for CHS-0214. The increase in R&D expenses in the first nine months of 2016 over the same period of 2015 was mainly attributable to proceeding with the clinical activities associated with the Phase 3 clinical study in psoriasis for CHS-1420, advances in other product candidate and hiring additional personnel to support both late development and other stage activities, partially offset by a decrease in cost related to BLA enabling studies for CHS-1701 and a decrease in cost associated with the CHS-0214 Phase 3 trial that were completed at the end of 2015. General and administrative expenses for the third quarter of 2016 were $13.6 million, compared to $10.2 million for the same period in 2015. G&A expenses for nine months ended September 30, 2016 was $36.3 million as compared to $25.1 million for 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 third quarter of 2015, and legal fees to support the intellectual property strategy. Net income attributable to Coherus for the third quarter of 2016 was $83.9 million, or $1.67 per share, compared to net loss of $71.3 million, or $1.86 per share over same period in 2015. We will now turn the call to Q&A. Operator; you may open the call to questions. Thank you.

Operator

Operator

[Operator Instructions] And I am showing our first question is from Mohit Bansal with Citigroup. Your line is now open.

Mohit Bansal

Analyst · Citigroup. Your line is now open

Taking my question. So I have two questions if I may. First one relates to Neulasta biosimilar and specifically now we have seen almost a year of launch of Neupogen biosimilar from Sandoz, so how do you characterize that particular launch given that Sandoz has reported more like $100 million or so revenue and how do you characterize that launch and what we have learned from that launch which could help you when you launch your own product. And the other one is more broad question with the revenue precedent and then Republican victory, I mean chatter around the Affordable Care Act, what kind of risk do you see to 351(k) pathway and then given that you already filed for one, you are pretty close to for others, do you see you are protected or how do you see that happening? Thank you.

Denny Lanfear

President

Thank you, Mohit. This is Denny. Let me let the company's senior VP of Commercial Strategy, Michael Fleming who is with us today first comment on your question regarding the Sandoz of their launch and then I'll follow up with some color on the Affordable Care Act and the biosimilar act. Michael?

Michael Fleming

Analyst · Citigroup. Your line is now open

Yes, thanks for the question. So questions really about the Zarxio launch, launch and how do we view it. Amgen communicated on their call that biosimilar penetration into Neupogen business is now about 40% and growing. And in fact if you look at the uptick of Zarxio, it is looking exceed the uptick trajectory of Granix they launch previously into the space. So we see this performance overall as very encouraging for the acceptance of biosimilar in the oncology space. And in terms of the market research that we've done, the customers that we talked to, the basic supply in terms of really doing effective messaging on quality of the product, the reliability of the supply as well as the value proposition. Some of the softer and harder aspects of value. Contracting pricing is important but also patient support services. So again we see this is very encouraging for the category. I would also say that Neulasta, we think there is going to be much, much greater pent-up demand for Neulasta than there would be -- for Neulasta about similar than they would be for a Neupogen biosimilar.

Denny Lanfear

President

And let me secondarily address your question ACA and biosimilar act, it is true that the biosimilar act this part of Affordable Care Act, however biosimilar act is working quite well. As you know, number of products has been approved with full label extrapolation. These will be beneficial to the market place overall for pharmaceutics. There has been no criticism of the biosimilar act that we have heard in this context. This is a legitimate pre-market approach to helping control pricing in the pharmaceutical market. That was a very pro competitive approach. We would expect administration to be somewhat sympathetic to it. So we don't foresee any issues or any changes. In our view it is working well and it is something that would be welcome.

Operator

Operator

And our next question is from Alethia Young with Credit Suisse. Your line is now open.

Elian

Analyst · Credit Suisse. Your line is now open

Hi, guys, this is [Elian] filling for Alethia. Thanks so much for taking the question. Could you give us a little bit more color on the Humira biosimilar formulation you have specifically what preclinical and clinical work you have done already? And then also could you comment on how long you expect the PK study to take? Thanks.

Denny Lanfear

President

Hi, thank you. With all respect we will decline to discuss the particulars of the pre-clinical stat of any other formulation. However, we as just guided to a first half of 2017 start for a pharmacokinetic which is really the milestone. I suggest that you be focus on and I believe that it is fair to say that such study would probably take around six months to execute and so forth as we discussed previously another call and forums, and lastly I'd say a number of formulation of course that we have developed over time as contingency for various legal development in the Humira space. As you may recall, we've keep very strong track of the intellectual property development here. And you could expect that we would have corresponding formulation strategies dovetail scientific strategies matching certain legal development as we proceed with the product. So we have in the past moved forward with a number of options in parallel and this is a case of us exercising one of those options.

Operator

Operator

[Operator Instructions] And our next question is from Jason McCarthy with Maxim Group. Your line is now open.

Jason McCarthy

Analyst · Maxim Group. Your line is now open

Hi, guys. Thanks for taking the question. I have just a question about potential partnering opportunities for your TNF. I guess my knowledge you are the only group that has two TNF biosimilars, are you considering potentially partnering them as a pair almost like a TNF little franchise? Nobody else has I think it could be a tremendous opportunity. I want to get your thoughts on that. Thanks for taking the question.

Denny Lanfear

President

Thanks Jason. Yes, thank you for that question. We point that out in our prepared remarks. We think there is of course a high complementarity in terms of the anti-TNF. As you know, patients regularly rotate from one of these products to the other and they are therapeutically interchangeable to some degree. Some patients do better one and the other some patient stay long and one than the other. So we think there is a powerful value proposition they have both products in hand. Particularly in the case for example the European market where you are able to access both those product at the same time. And as well as other markets also. So we thought it was actually fortuitous that the return of the asset from Shire occurred concurrently at the time when we had just initiated the 1420 biosimilar out licensing process. So we are encouraged and actually made that note. I appreciate your insights and I would agree with that. And so we'll give a little update as we go on. And as you call, we've got into first half of 2017 for a deal on these assets.

Operator

Operator

And we have time for one more question comes from Douglas Tsao of Barclays. Your line is now open.

Douglas Tsao

Analyst · Barclays. Your line is now open

Hi, good afternoon. Thanks for taking the questions. Denny I know it is obviously been early with the decision from PTAB on 166 patent, I was just curious if in the interim you had any sort of conversations with any of those third party that you had partnership talks with on the -- for the anti-TNF and how is that sort of affected sort of interest in the product?

Denny Lanfear

President

Hi, Doug. Thanks for the question. I'd decline to provide additional comment on our partnering on such a frequent basis. And we'll be happy to update partnering on the call but as you know the company's long stand position is not to offer a blow by blow, stage by stage this sort of commentary on its partnering effort to the market. We don't believe that's appropriate. And we won't do so now. That being said, with this product we believe that the attractiveness of 1420 and asset is broad because of its global reach. There are a number of markets beside the US where there is particular patent plays a significant role. Particularly for example in Europe where we just pointed out that we have both the 0214 Enbrel asset and this asset available and in play as well as in other territories. The second point that I would make also is that we have a parallel track opportunities in terms of the formulation and approaches, we approach this in a multi prong fashion as you recall from our earlier conversations. So we will continue to go forward with those but I think it is clear and I talked about it on Monday and then again on Tuesday when I was at Credit Suisse, we don't believe this is last shot fired at all in terms of the formulation patent on 166 or IP overall.

Douglas Tsao

Analyst · Barclays. Your line is now open

Okay, great. And then if have you ever given consideration to development of your own sort of on- body type of system, just given the fact that I hear your [Technical Difficulty]

Denny Lanfear

President

I am sorry Doug I missed the second part of your question.

Douglas Tsao

Analyst · Barclays. Your line is now open

I just curious if have you ever considered sort of development of your own sort of on-body type of device?

Denny Lanfear

President

Well, let me say that was -- that comprises a strategic question which I would probably decline to comment further on in this forum. But let me say that we have a number of folks on our team who are very, very familiar with the on- body system with Neulasta and very, very familiar with the value proposition. So if we certainly thought that was something that we should do or wanted to you could predispose that we would, go ahead and look a little further end to that. And I think that we are very familiar as we point with the value proposition on that. So I certainly leave it there. But we will be happy to provide update on you as time goes on that particular topic.

Operator

Operator

And we have time for one question. [Operator Instructions] And with no additional question, I'd now turn the call back over to Mr. Lanfear for closing remarks.

Denny Lanfear

President

All right. Thank you very much. Thank you all for joining the call today to receive the update on our product. And we look forward to talking to you again on our next earnings call. Thank you. Bye, bye.