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Collaboration

Feb 1, 2021

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Coherus BioSciences, Inc. conference call. All lines have been placed on mute to prevent any background noise. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone keypad. I would now like to hand the conference over to your first speaker for today, Mr. David Stilwell. Please go ahead.

David Stilwell
CFO, Atsena Therapeutics

Thank you, operator. Good morning, everyone, and thank you for joining us. We issued a press release earlier announcing our collaboration with Junshi Biosciences. This release can be found on the Coherus BioSciences website. Today's call includes forward-looking statements regarding Coherus's current expectations.

These statements include, but are not limited to, statements relating to our collaboration with Junshi Biosciences, the stock purchase agreement between Coherus and Junshi Biosciences, our co-development of toripalimab monotherapy and combinations, our ability to successfully register toripalimab in the United States and Canada, our ability to successfully commercialize toripalimab and other licensed compounds, and our success registering and commercializing our late-stage biosimilar product candidates, as well as our uses of capital.

All of which involve certain assumptions, risks, and uncertainties that are beyond our control and could cause actual results to differ from these statements. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are discussed in documents that we file with the Securities and Exchange Commission, specifically in our quarterly report on Form 10-Q for the quarter ended September 30th, 2020.

The forward-looking statements stated today are made as of this date, and we undertake no duty to update such information, except as required under applicable law. Joining me for today's call are Denny Lanfear, Coherus's Chief Executive Officer, and Dinesh Purandare, Executive Vice President of Commercial Strategy and Operations. I'll now turn the call over to Denny.

Denny Lanfear
President and CEO, Coherus BioSciences

Well, thank you, David. Thank you everyone for joining us on the call this morning. Our mission at Coherus has been to expand patient access to life-changing medicines and to deliver significant savings to the healthcare system. We have been successful in delivering on that promise with our first product, UDENYCA.

Today, I'm very excited to announce that we are expanding our mission to immuno-oncology. We have entered into a collaboration agreement with Junshi Biosciences to acquire exclusive rights in the United States and Canada to toripalimab, the anti-PD-1 antibody Junshi Biosciences has been developing in an extensive pivotal clinical development program across multiple indications. In addition to toripalimab rights, we will also acquire options to two exciting pipeline programs for potential combination with toripalimab.

The first is an anti-TIGIT antibody that is expected to enter development in the U.S. later this year, and the second is a next-generation engineered IL-2 cytokine. We also have obtained certain negotiation rights to two preclinical checkpoint antibody programs, checkpoint inhibitor antibody programs.

We will pay Junshi Biosciences $150 million in cash upfront, a 20% royalty on net sales of toripalimab in the U.S. and Canada, and up to $380 million for the achievement of certain development, regulatory, and sales milestones, of which $290 million are payable on attainment of certain sales thresholds. The option exercise fee for the anti-TIGIT antibody and the IL-2 cytokine is $35 million per program, exercisable prior to phase II studies.

Assuming we exercise the options, we will pay a portion of future development costs, an 18% royalty on net sales, and up to $255 million per program for achievement of certain development, regulatory, and sales milestones, of which $170 million are payable on attainment of certain sales thresholds. Junshi Biosciences and Coherus will co-develop toripalimab and licensed compounds, Coherus will pay a portion of the development cost, up to $25 million per year per compound.

This is a transformational transaction which expands our pipeline to include the rapidly growing checkpoint inhibitor market, which is expected to exceed $25 billion by 2025, and provides us the essential PD-1 backbone for development of next-generation combination therapies. We are excited to partner with Junshi Biosciences. They are a leading Chinese biotech company with a dedication to innovation and global clinical capabilities.

Their mission is to provide patients with better treatment options that cost less, which is very consistent with our own. Junshi Biosciences has a broad pipeline which includes not only immuno-oncology, but also immunology, cardiology, and the CNS therapeutic areas.

They also have deep experience with drug development and with the U.S. FDA. Dr. Li Ning, Junshi Biosciences' CEO, worked at FDA for 13 years, and Dr. Patricia Keegan, their medical officer, their Chief Medical Officer, was an oncology reviewer and a director at FDA for more than 30 years.

Dr. Keegan also served 16 years as Division Director of Oncology Products, and most recently, she was Acting Associate Director of Medical Policy for the Oncology Center of Excellence. Toripalimab has a compelling late-stage profile that is being developed in an extensive clinical program that is well underway, with more than 2,100 patients having received toripalimab in 15 pivotal trials in multiple settings, in tumor types including cancers of the lung, esophagus, nasopharynx, breast, bladder, kidney, liver, and skin.

In China, toripalimab is already approved for the second-line treatment of unresectable or metastatic melanoma. In the United States, we expect the first BLA to be filed later this year for nasopharyngeal carcinoma, an unmet need for which FDA has granted Breakthrough designation for toripalimab.

Following nasopharyngeal carcinoma, Coherus and Junshi expect to file additional BLAs over the next several years for multiple rare and prevalent cancers, including non-small cell lung cancer.

Toripalimab will fit very well with our existing commercial infrastructure that has been very successful in the promotion of UDENYCA. We have a commercial team of approximately 140 employees, including nearly 100 who are field-based. We expect to fashion a well-rounded value proposition, as we did with UDENYCA, to ensure commercial success of toripalimab.

We have well-developed relationships with group purchasing organizations, independent delivery networks, payers, and prescribers, and we are confident that our team will be able to deliver the toripalimab value proposition for the benefit of patients.

The options on JS006, an anti-TIGIT antibody, and JS018, an IL-2 cytokine, are potential long-term drivers of growth for Coherus. TIGIT is a clinically validated target that has shown synergistic antitumor activity with PD-1 inhibitors. We expect clinical development of JS006 to begin in the U.S. this year.

JS018 is a next-generation engineered IL-2 cytokine designed to inhibit stimulation of regulatory T cells while retaining stimulatory activity on effector T cells and natural killer, so-called NK cells. The future option costs for Coherus will be $35 million per program, and the option must be exercised following an evaluation period prior to initiation of phase II development.

This will be an exciting transition for our company. Our progression into immuno-oncology will be marked by multiple milestones as the toripalimab monotherapy and combination programs advance through key clinical development readouts and regulatory submissions.

Later this year, we plan to have an Analyst Day event to focus on our immuno-oncology programs. Before I turn the call to your questions, let me make a point about the implication of today's announcement on our corporate strategy.

We plan to invest cash generated by our successful biosimilar commercial business to build a focused immuno-oncology franchise, which will leverage our proven commercial capabilities into large and growing markets. We will prudently allocate our R&D resources to realize the exciting potential of toripalimab monotherapy.

With respect to biosimilars, our focus will be on commercialization as we continue to pursue UDENYCA market share growth and prepare for projected launches through 2023 of biosimilars of HUMIRA, AVASTIN, and LUCENTIS, if approved.

Our partnership with Junshi Biosciences for toripalimab and potential combinations is a tremendous opportunity for our company, and I'm excited to discuss it with you all now. Operator, this concludes our prepared remarks. Please open the line for questions.

Operator

We will now begin the question and answer session. If you wish to ask a question, please press star one on your telephone and wait for your name to be announced. We'll pause for just a moment to compile the Q&A roster. Your first question comes from Mr. Jason Gerberry of Bank of America. Sir, your line's now open.

Ashwarya Sharma
Analyst, Bank of America

This is Ashwarya Sharma on for Jason. I had two questions. One is just in terms of the initial opportunity, the BLA that you're planning to file for the third-line nasopharyngeal carcinoma, what is the patient size in the U.S. and Canada for this? That's my first question. The second one which BLA can we expect to be the next, and which indications would it focus on? Thanks.

Denny Lanfear
President and CEO, Coherus BioSciences

Thank you for your question. I will let Dinesh address the issue of the size of the markets. Dinesh?

Dinesh Purandare
Business Development and Strategy Genomics/ Broad Clinical Labs, Broad Institute of MIT and Harvard

Thank you. This is Dinesh. Thank you very much for your question. As you well know, nasopharyngeal carcinoma is a high unmet need area. It's a niche indication for which we have a breakthrough designation. The U.S. incidence generally is in the range of seven patients per million. That's the total population in the market.

Denny Lanfear
President and CEO, Coherus BioSciences

Thank you, Dinesh. With respect to further follow on BLA filings or indications, Junshi is currently prosecuting the development of therapies in a number of areas, as I outlined, including lung, esophageal, et cetera. Subject to certain conversations and deliberations with the FDA, we will jointly decide on which additional indications will be filed and in what sequence. During our Investor Day a little later this year, we'll be happy to give you a clearer snapshot of how we see these indications and BLAs rolling out over the next couple of years.

Ashwarya Sharma
Analyst, Bank of America

Great. Thank you. Congrats on the deal.

Operator

Thank you. Your next question comes from Mohit Bansal of Citi. Your line is now open.

Speaker 12

Hey, morning, guys. Congrats on the deal. This is James on. Could you give us any updates on the LUCENTIS program real quick? Secondly, if we could go back to tremelimumab. I know you just said the readout timings, or sorry, the BLA timings will be disclosed at an investor event, can you go over maybe some potential readout dates for the non-small cell lung cancer trials?

Denny Lanfear
President and CEO, Coherus BioSciences

Hi. Thank you very much for the question. With respect to the LUCENTIS program, we'll be providing an update on that on our quarterly call. As you recall, there was meetings with FDA that were scheduled.

I can say that those meetings did occur. Secondarily, with respect to the timing of the follow-on indications, we have a number of clinical trials that are reading out, and we think that it's best to take the opportunity a little later to delineate all those in conjunction with Junshi for you. Stay tuned.

Speaker 12

Got it. Just one more. Could you disclose if JS006 has an active or silent Fc region?

Denny Lanfear
President and CEO, Coherus BioSciences

I cannot disclose such at this time.

Speaker 12

Got it. Appreciate it, guys. Congrats on the deal. Thank you again.

Operator

Thank you. Your next question comes from Salim Syed of Mizuho. Your line is now open.

Salim Syed
Analyst, Mizuho

Great. Good morning, thanks for the question, Denny, and congrats on the deal. Just a couple from me, if I can. Just one high-level strategy question here. As you're thinking about the future of this business, should we be thinking now that you no longer want to acquire additional biosimilars, but you want to build your business around the novel oncology market?

If that's so, what does that say about the strategy in biosimilars? Is there something about the biosimilars in general that has caused you to go down this path of going into novel therapies? The second question is just on the discontinuation of EYLEA. Was there a particular reason to discontinue EYLEA other than resources? Is this an asset that you plan to divest at some point? Thank you.

Denny Lanfear
President and CEO, Coherus BioSciences

Thanks, Salim. Excellent questions. First of all, with respect to EYLEA, we had penciled in approximately $200 million in R&D expenditures, including phase III clinical trials for that program over the next couple of years, and I think on previous calls we've discussed that with you.

When that product went to market, that product would go into perhaps a $4 billion, $5 billion, $6 billion market where we already have Lucentis product coming forward, as we've disclosed.

We felt that it was much better to invest those dollars, particularly those R&D dollars, in immuno-oncology products. Keeping in mind, of course, that PD-1 is a proven target with a very large market, and the TIGIT and the other targets also have seen very good clinical efficacy.

It really is a question of using our dollars to approach, say, a $30 billion product opportunity as opposed to a $4 billion or $5 billion product opportunity. We plan to continue with LUCENTIS in the ophthalmology space, which of course we have apprised you of our progress there.

I think what it says mostly for our strategy in terms of these things is that we will deploy investors' capital and the cash generated from the biosimilar business into markets and therapeutic areas which are growth markets in which we feel we can deliver our value proposition on the commercial side with a lot of confidence.

I don't think that you will see us using our R&D dollars for further biosimilar development on the early stage side, but you will see us continuing to commercialize biosimilars and to harvest the value of our previous investments with CHS-1420, for example, our HUMIRA biosimilar, where the BLA was filed, et cetera. Is that helpful?

Salim Syed
Analyst, Mizuho

Yeah, super helpful. Thanks, Denny.

Denny Lanfear
President and CEO, Coherus BioSciences

Thanks, Salim.

Operator

Thank you. Your next question comes from Balaji Prasad of Barclays. Your line is now open.

Balaji Prasad
Analyst, Alvotech

Hi, good morning, everyone, congrats on the deal. Denny, I just wanted to go back to the previous question and tie up with some of our past conversations. You have flagged biosimilar EYLEA as a bigger opportunity in the past, and that LUCENTIS would be a learning experience to launch your own biosimilar EYLEA.

I can't help but think that there's a reversal of stance on biosimilars. You mentioned that you won't be using R&D dollars for future biosimilars. Would we also be ruling out any kind of approved or commercial biosimilar licensing to piggyback on your commercial strength? I'll come back to the next set of questions. Thanks.

Denny Lanfear
President and CEO, Coherus BioSciences

Yeah. That's a great question. Thank you. I think it's more of an issue for us of the appropriate allocation of R&D resources and the cash flows from our biosimilar business. As I said, we feel that the immuno-oncology area presents us with the opportunity of prosecuting our proven value proposition commercially into much larger and growing markets.

With respect to biosimilars, let me be clear, we're still quite open to biosimilar deals and commercialization and so forth going forward, but those don't really require the sort of R&D spends that the EYLEA program would have.

You will see us using our R&D primarily for the immuno-oncology, and we will see us commercializing and harvesting the value of our biosimilar portfolio. If we see other biosimilars come by, which we think are very accretive, we'll look at those very carefully. It's an excellent question.

Balaji Prasad
Analyst, Alvotech

Thanks, Denny. Second part of my question on toripalimab. There are multiple checkpoint inhibitors in the market. You have laid out a few areas where you think this has most promise. With the amount of IO drugs in development in the market, where exactly would you stand with the commercial opportunity with the drug?

Denny Lanfear
President and CEO, Coherus BioSciences

I think that it's fair to say that we're fairly confident in translating our commercial value proposition into these markets. We did very well against an entrenched competitor, as you know, with UDENYCA, and we feel that our competency really is displacing entrenched competitors in the market. We are not afraid of competition.

We think that we are fierce and very competent competitors. I think that our commercial team has demonstrated their capabilities both with the initial launch, as you recall, of UDENYCA. We exceeded 20% market share in the first year, our performance during COVID, during some very adverse conditions. We think that the immuno-oncology arena is ripe, A, for savings, and B, for the sort of holistic, well-rounded value proposition that Coherus has a very strong track record of delivering.

Balaji Prasad
Analyst, Alvotech

Thanks.

Operator

Thank you. Your next question comes from Georgi Yordanov of Cowen and Company. Sir, your line's now open.

Georgi Yordanov
Analyst, Cowen and Company

Thank you so much for taking my question, congratulations on the deal. Just a couple from us. Just following up on the previous question, how do you see the long-term pricing dynamics play out in the PD-1 space given those multiple competitors in development?

Denny Lanfear
President and CEO, Coherus BioSciences

That's an excellent-

Georgi Yordanov
Analyst, Cowen and Company

Follow up. Okay, great.

Denny Lanfear
President and CEO, Coherus BioSciences

That's an excellent question. I'm going to allow Dinesh to make some comments about that with respect to the pricing and so forth. Dinesh?

Dinesh Purandare
Business Development and Strategy Genomics/ Broad Clinical Labs, Broad Institute of MIT and Harvard

Yeah, thank you, Denny. At this point in time, it's hard to pinpoint on the pricing strategy, but what I can talk about is our strategy and success with UDENYCA that positions us very well in this marketplace to compete with the entrenched bio, other immuno-oncology molecules.

As Denny mentioned, we plan to deploy a holistic approach to deliver our value proposition. We have a very good and strong commercial footprint already out there, which we believe fits our needs in the initial indications as well.

Denny Lanfear
President and CEO, Coherus BioSciences

Thanks, Dinesh. I'll just make a further comment here. In the UDENYCA space with pegfilgrastim, as you can see, we have been very disciplined in terms of price and discounting. As a matter of fact, our ASP I think right now is actually above that of the competitors, particularly Amgen. Our strategy will be to deliver value and not necessarily price cuts and so forth.

We think these markets will be receptive to value. Further, we think that we will have a very well-rounded label. Junshi has a very complete development program for this asset. There's some 15 pivotal trials ongoing that already have 2,100 patients. There'll be over 5,000 patients when enrollment is completed over a whole number of cancers. I think that we'll have a very fulsome label with which to approach the oncology environment.

Georgi Yordanov
Analyst, Cowen and Company

Thank you. I guess just a slightly broader question. What are some of the key challenges you anticipate in marketing an immuno-oncology product from a commercial perspective? I guess what is your strategy of how that would be different from your UDENYCA strategy?

Denny Lanfear
President and CEO, Coherus BioSciences

We'll decline to go further with respect to our market penetration strategy and our competitive strategies at this time. We think it probably wouldn't be appropriate to get too far into that as we presage these things, and we are going to focus on the co-development with our partner, Junshi, and focus on getting the BLAs filed and approved. We will have more to say from time to time on our competitive strategies, of course, with these products.

Georgi Yordanov
Analyst, Cowen and Company

Thank you. This is helpful. Thank you so much.

Denny Lanfear
President and CEO, Coherus BioSciences

The last point that I would make, however, to you is that we looked at a number of PD-1s over the past two years. We think that it was very important for us to get a very good PD-1, and not all PD-1s are created equal. One of the things you may note is that this was a transaction that took us some time to complete. On our quarterly calls, we had presaged that we were looking at various areas for quite some time. We felt that it was very important to get the right molecule with the right clinical and pre-clinical profile and the right partner.

One of the reasons that it took some time to accomplish this is we were very careful in our partner selection, and we're very happy with Junshi, both the company and the molecule toripalimab.

Georgi Yordanov
Analyst, Cowen and Company

Thank you.

Operator

Thank you. Your next question comes from Mr. Gregg Gilbert of Truist Securities. Your line is now open.

Gregg Gilbert
Analyst, GG Advisory Group

Thanks. I have a couple. Denny, I have a fundamental question about whether you've assessed a biosimilar strategy for the PD-1s before taking the route you did today. How do you get comfort with the fact that a more brand-like strategy or value brand strategy like you're discussing will hold up when KEYTRUDA biosimilars roll in in 2028?

That's kind of a fundamental business model question, and you're going to go indication by indication, presumably, to get approvals and find niches in the marketplace, a market that doesn't really care about price today. Curious about whether you sort of considered and ruled out a biosimilar PD-1 strategy. I have another.

Denny Lanfear
President and CEO, Coherus BioSciences

Yeah. Great. Let me just unpack that a little bit. First of all, I think that the jury is still out with respect to what the actual timing would be for biosimilars, say, to KEYTRUDA in 2028. As you saw with HUMIRA, the composition of matter patents actually expired in December of 2017, yet you're not having any launches of HUMIRA biosimilars until 2023, some six years later. I think that one should not underestimate how long it'll take biosimilar PD-1s to move forward.

The second point that I would make is that the phase III, the comparative studies, in oncology could be very difficult for biosimilars to KEYTRUDA. Showing non-inferiority and so forth may entail very large patient populations in large cancers. Those conversations have yet to happen with the FDA.

With respect to this, we felt that this was an appropriate way to approach the PD-1 opportunity. I would challenge you a bit on the notion that there is no price pressure or price sensitivity in the market. The PD-1s could be $14,000 per patient per month and up. They're very expensive.

While we don't intend to discount our way into the market, just as you saw us very restrained with UDENYCA, we feel that there's increasing burden on the healthcare system due to the incoming combination therapies in the future. Certainly from 2025 forward, you're going to see PD-1 as a cornerstone of immunotherapy with cancer, and then these other modalities such as TIGITs and so on will be stacked on top.

That begins to present a very onerous cost burden for the healthcare system, even as benefit is delivered to the patients and progression-free survival is extended and these other issues. On the other hand, we think this market is an excellent place to go to deliver, as Dinesh said, a very well-rounded value proposition. Is that helpful?

Gregg Gilbert
Analyst, GG Advisory Group

Yes. Just to follow on to that, do you think you need to get certain indications approved that are exactly the same as the market-leading PD-1s to enable price competition? As far as I understand it now, payers and physicians are not willing to sort of consider price in using a product off label, even though they view PD-1s to be somewhat similar to one another. Do you need to sort of get some label normalization versus competition, or is it all about going where they are not?

Denny Lanfear
President and CEO, Coherus BioSciences

Well, no, it's not about going where they are not. That would be a full-on niche strategy. I think I outlined earlier to you that Junshi has successfully moved forward with clinical trials in a number of areas.

Not just lung, but esophageal and a number of other places. We anticipate a very fulsome label. We anticipate label-to-label competition in this market, and that's one of our strategies. One of the reasons that we are attracted to the Junshi asset is that it had a very broad development program behind us. Absolutely not a niche strategy.

Gregg Gilbert
Analyst, GG Advisory Group

Great. Just one last one about the TIGIT and the IL-2. When do you expect to learn something material on those that would drive a decision to opt in or not? Could that be as soon as next year, or are we talking a few years out? Thanks.

Denny Lanfear
President and CEO, Coherus BioSciences

Yeah, that's a great question. The TIGIT will enter clinical development later this year. It'll start in phase I and progress through that. I would say 2022 would be a time we can have another conversation with our partners about the progress on that. Certainly, we'll keep you updated from time to time on that progress. The opt-in, though, will not happen in 2021.

Gregg Gilbert
Analyst, GG Advisory Group

Thanks.

Operator

Thank you. Your next question comes from Sir Douglas Tsao of H.C. Wainwright. Your line is now open.

Douglas Tsao
Analyst, H.C. Wainwright

Hi, good morning, and thanks for taking the question. Congratulations, Denny. Just first, just curious, your appetite now for expanding into new molecules. Are they going to be focused largely in IO?

You have the TIGIT and IL-2. I don't know how much more you feel like you need in the portfolio. Do you expect to be making investments in other novel oncology assets for use in combination, apart from what you have with Junshi? How big a portfolio do you think you need or can handle right now?

Denny Lanfear
President and CEO, Coherus BioSciences

Hi, Doug. Thanks for the question. I think that this is enough for now. Certainly moving the PD-1 forward and commercializing over the next couple of years as the BLAs are filed and approved will be a commercial undertaking for us that we're ready for. Also, we're very cognizant of not overspending on the R&D side with these products. Both the IL-2 and the TIGIT are very promising.

One of the things that you may note from this agreement is that we have capped our R&D contribution to $25 million per year per molecule. We did that because we wanted to have a very accretive, rational strategy going forward.

One of the things I would say is that, we do not intend to spend significantly, in the short term with these assets in immuno-oncology. Secondarily, we will not be looking for additional immuno-oncology assets to in-license.

That being said, if a significant opportunity came up that was compelling, certainly we would look for it. We think that this agreement provides us with a very well-integrated product portfolio and pipeline, a highly synergistic strategy with an excellent partner with a few very good molecules.

Douglas Tsao
Analyst, H.C. Wainwright

Okay. Just one follow-up. Just one. Maybe characterize how it sounds like you're going to be looking to potentially in-license biosimilars. Those would presumably be assets that are in phase III, or are you going to be looking for assets that have already cleared phase III and wholly would be commercial investments on your part? Just a quick follow-up, could you just provide some color on the trajectory of your R&D spend now that you won't be investing in EYLEA?

Denny Lanfear
President and CEO, Coherus BioSciences

Yeah. With respect to biosimilars, what we're clearly signaling to you is that we will not be spending on phase III programs for biosimilars. Right? We have chosen to deploy our available R&D spend to immuno-oncology. For your question, we would be open to biosimilars that would be very late stage, post phase III-ish sort of assets, but not, I would think, moving forward with biosimilars in phase III.

That's a very clear departure point for us. With respect to R&D spend, as I indicated a little while ago, we had spent about $200 million over the coming two or three years-ish for the EYLEA program.

The strategy here is instead of spending on EYLEA and approaching a $4 billion-$5 billion market that was shrinking, we're going to add about $30 billion to our target product opportunity in the therapeutic areas, which is expanding. With respect to further sort of guidance with R&D, we'll update you on the calls from time to time on that.

Douglas Tsao
Analyst, H.C. Wainwright

Okay, great. Thank you.

Operator

Next question comes from Mr. Jason Gerberry of Bank of America. Sir, your line is now open.

Ashwarya Sharma
Analyst, Bank of America

Hi, this is Ash again. Just a quick follow-up. The initial BLA that you're planning to file, would that be an accelerated approval pathway? Is there a confirmatory trial going on, or is it just like a straight regular approval? Thanks.

Denny Lanfear
President and CEO, Coherus BioSciences

Thanks for the question. I'll let McDavid Stilwell take that one. McDavid?

David Stilwell
CFO, Atsena Therapeutics

Sure. Junshi has engaged with FDA on that nasopharyngeal carcinoma indication, and toripalimab has been granted Breakthrough Therapy designation. We would expect that there would be an accelerated approval pathway potential for that indication.

Ashwarya Sharma
Analyst, Bank of America

Got it. Thank you.

David Stilwell
CFO, Atsena Therapeutics

Thank you.

Denny Lanfear
President and CEO, Coherus BioSciences

We'll also have more to say about all of this on our quarterly call a little later this month.

Operator

Thank you. Again, if you wish to ask a question, please press star one on your telephone. Your next question comes from Mr. Jason McCarthy of Maxim Group. Sir, your line's now open.

Michael Chanowitch
Analyst, Maxim Group

Hi, this is Michael Chanowitch on for Jason. Thanks for taking my question. I'd like to see if you could talk about what went into the decision to choose Junshi's molecules over other PD-1s out there. More specifically, some of the particular advantages of toripalimab, or was this more about the breadth of their development program?

Denny Lanfear
President and CEO, Coherus BioSciences

That's really a great question. One of the things we did in approaching the PD-1 market is we developed a sophisticated set of preclinical and clinical methods in which we could take a look at the various attributes of PD-1s. In terms of, say, finding affinity for the receptor, one of the unique things about the Junshi molecule is that it is internalized post-binding, which is a somewhat unique mechanism of action.

We looked at pharmacokinetics, on rate, off rate. We had a number of proprietary assays that we looked at in which we tested a number of PD-1s head-to-head. I think overall, we probably considered over a dozen PD-1s over the past two years. Of those, we tested at least, I would say, six or eight PD-1s in these proprietary assays, in which we got a very good idea of how they behave.

To your second point, I think what is also very attractive is the very thoughtful, thorough, and science-driven way that Junshi has approached the PD-1 therapeutic area market. I would point out to you that Dr. Patricia Keegan, who is formerly with the FDA immuno-oncology division, is the Chief Medical Officer at Junshi.

I think that Dr. Keegan has been very thoughtful with Junshi in terms of how they have proceeded with their development and their indications. We look forward to working with her as we prosecute these further and get the BLAs filed.

Michael Chanowitch
Analyst, Maxim Group

All right. Thank you. Just one follow-up, if you don't mind. You talked about PD-1s becoming essentially a cornerstone regimen for immuno-oncology. Is the goal of this transaction ultimately to get in on that, and then eventually pull in additional molecules to create internal combinations with toripalimab and compete on that novel combination therapy side?

Denny Lanfear
President and CEO, Coherus BioSciences

The short answer to that question is yes. We see PD-1s becoming very, I won't say ubiquitous, but I would say very broadly used as the foundation for the rest of immunotherapy. Patients, I think, will get PD-1s, and then in addition to that, they will get things like the tiragolumab or the engineered IL-2 and CTLA-4s or any number of things.

Yes, our strategy here was first to secure a PD-1, and then, in terms of follow-on therapy, these additional molecules which increase the effectiveness. That's what you see with some of the clinical data coming out of tiragolumab and so on.

David Stilwell
CFO, Atsena Therapeutics

I would add that it's a really nice program for us strategically. If you think about what Coherus has in the pipeline, in the next couple of years, we should have four biosimilars approved within I-O/onc. We expect for that biosimilar top line to diversify and continue to grow. The PD-1 opportunity will layer in on top of that.

It fits very nicely with our commercial capabilities, also over a period of years, we'll build out the indication set there. In the longer term, the combination possibilities built on top of toripalimab give us longer-term growth potential that we think is just tremendous. Strategically, we think this is a great fit for us.

Michael Chanowitch
Analyst, Maxim Group

All right. Thank you very much, and congratulations on the news.

Denny Lanfear
President and CEO, Coherus BioSciences

Thank you.

David Stilwell
CFO, Atsena Therapeutics

Thank you.

Operator

Thank you all. No more questions over the phone. Presenters, please go ahead.

Denny Lanfear
President and CEO, Coherus BioSciences

Thank you very much for joining us this morning. We are very excited to be working with our new partner, Junshi, on PD-1, and these follow-on molecules as they arise and so forth. We'll be happy to give you an update on the LUCENTIS program, a meeting with the FDA, which we view as successful in validating the strategy of moving forward there on our quarterly call. Thank you once again for joining us. Bye-bye.

Operator

This concludes today's conference. Thank you all for joining. You may now disconnect.