Ladies and gentlemen, thank you for standing by, and welcome to the Fourth Quarter and Full Year 2020 Coherus Biosciences Conference Call. [Operator Instructions] I would now like to turn the conference over to your host today, Mr. McDavid Stilwell. Sir, please go ahead..

Thank you. Good afternoon, everyone, and thank you for joining us. We issued a press release earlier announcing our 2020 fiscal year and fourth quarter results and the release can be found on the Coherus Biosciences website. Today’s call includes forward-looking statements regarding Coherus' current expectations.

These statements include, but are not limited to, our ability to advance our biosimilar and immuno-oncology product candidates through development and registration; our commercialization of UDENYCA and other potential products in the future. Our ability to meet our R&D and SG&A expense guidance for 2021 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 30, 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, Chief Executive Officer; Jean Viret, Chief Financial Officer; Vin Anicetti, Chief Operating Officer; and Chris Thompson, Executive Vice President of Sales. I'll now turn the call over to Denny..

Thank you, McDavid, and welcome everyone to our call. This afternoon I will review recent business highlights and pipeline progress. Chris will provide his perspective on pegfilgrastim market dynamics and fourth quarter UDENYCA performance.

And Jean Viret will discuss fourth quarter and full year 2020 financial results, as well as expense guidance for 2021. We will then open the call for questions. Certainly COVID-19 made 2020 a difficult year for UDENYCA, impacting our ability to grow market share as planned in the face of new competitive entrants.

While there will be some continued price share competitive pressure on UDENYCA sales in early 2021, we expect that as COVID recedes, we will reserve market share growth largely coming at the expense of Neulasta Onpro. We see 2021 is a year of fundamental transition and an inflection point for Coherus.

We are extending our mission and expanding our late stage pipeline to include immuno-oncology. We recently announced collaboration with Junshi Biosciences for U.S and Canada rights to their PD-1 inhibitor, toripalimab. The transaction is projected to close later this quarter.

Toripalimab has been evaluated for a wide range of tumor types in 15 ongoing or completed registrational trials. We eagerly anticipate the first BLA to be filed this year for nasopharyngeal carcinoma, which has been granted breakthrough therapy designation by the FDA.

Earlier this month, toripalimab was approved in China for this indication, and regulatory authorities there have also begun a review of toripalimab for first line treatment of nasopharyngeal carcinoma.

Over the next few years, we expect this, the extensive clinical development program to support multiple BLA submissions for rare and highly relevant tumor types, including lung cancer. As the label expands with new indications, we project significant revenue and sustained growth trajectory will follow.

Evaluating toripalimab combination with other immuno-oncology agents will provide longer term growth opportunities. As part of the collaboration, we will obtain options on anti-TIGIT antibody and engineered IL-2 cytokine as well as certain negotiation rights to two other immuno-oncology molecules.

Once the transaction is closed, Junshi Biosciences will purchase 50 million of Coherus common stock, an investment they wanted to make to share our future growth and mutual success with these programs. Now later this year, we plan to host an Analyst Day event to provide a deep look at all aspects of our business.

Our biosimilars, toripalimab, the option programs and our immuno-oncology strategy. Turning now to our core biosimilar business, I'm pleased with how our team performed in the face of COVID-19 headwinds through most of 2020. UDENYCA net sales of $476 million for 2020, drove $154 million in cash flow from operations for the year.

Chris will describe UDENYCA performance in more detail in just a few moments for you. First of all, let me review recent pipeline progress in our biosimilar business. With respect to our Humira biosimilar, CHS-1420, the FDA has accepted our BLA for review with a December 2021 action date.

Now the anti-TNF market represents a substantial opportunity for Coherus. After years of double-digit price increases with Humira, there is clearly significant pent-up demand for the type of biosimilar value that Coherus will deliver. There will be pair driven dynamic and they are heavily incentivized to force switching from the brand to biosimilars.

Our product, our patient focused offering and our manufacturing scale will match what payers are looking for. We are making manufacturing and supply investments to support our objective of capturing greater than a 10% market share. I'm also pleased to provide an update on our Lucentis biosimilar product candidate being developed by our partner Bioeq.

The FYB201 BLA is on track for a midyear 2021 submission, following a supportive pre-BLA meeting with the FDA earlier this quarter. As the sponsor of the BLA, Bioeq reviewed multiple elements of the plan filing, including the manufacturing data that the FDA requested last year. We're very excited about the potential approval of this product in 2022.

Ophthalmology has a similar buy and build business model to oncology with analogous critical success factors that our commercial team understands very well. We plan to leverage much of our existing infrastructure and core sales and marketing skills to gain a significant share of the overall $6 billion anti-VEGF ophthalmology market.

Regarding IBI-305, part of Avastin biosimilar product candidate in partnership with Innovent, we have initiated a three-way PK study, and we expect to provide additional updates on this program later this year. Our biosimilar portfolio which includes UDENYCA and biosimilars of Lucentis, Avastin and Humira addresses a $28 billion market opportunity.

We've already demonstrated our ability to use our branded marketing and other commercial capabilities to penetrate competitive markets with the biosimilar. We believe we will experience similar success taking significant share in these new markets.

We plan to invest the cash flows from the biosimilar business to build a robust and growing immuno-oncology franchise. Our strong UDENYCA performance and advanced biosimilar pipeline, together with toripalimab demonstrates solid progress on the strategy as we pursue the $25 billion PD-1 market opportunity.

I'll now turn the call over to Chris Thompson for an overview of the UDENYCA performance and the pegfilgrastim market dynamics.

Chris?.

Thank you, Denny. 2020 was a successful year for UDENYCA despite the challenges of COVID. In the fourth quarter, we delivered $110 million in net sales, driven by an increase in units that was offset by price decrease, and a larger percentage of our units coming from 340B accounts.

Share remained relatively stable in the fourth quarter, while the overall pegfilgrastim market grew 4% quarter-over-quarter in volume. We ended the year with wholesale inventory at the higher end of the normal range as is typically seen with most drugs in December, as we saw in 2019 as well.

In retrospect, the primary impact that COVID had on our business last year was to make it more difficult for biosimilar prefilled syringe competitors to take market share from Amgen's on body device during the spring and fall surges.

To a lesser extent, overall market volume was impacted with full year growth at 1%, down from the historical mid single-digit growth rates. Looking forward, as vaccination rates increase and COVID recedes, we anticipate greater customer desire to capture the potential savings represented by biosimilars in general and UDENYCA, in particular.

Specifically, we see greater than 50% share currently represented by Neulasta Onpro as a highly accessible source of UDENYCA growth in 2021. While we're not providing specific revenue guidance, we do expect UDENYCA revenues in 2021 compared to 2020 to be lower.

While the first quarter will remain challenging due to COVID-19, seasonal impacts gross to net and a depletion of the inventory that's built up at the end of the year, we expect revenue growth to resume in the second quarter.

As post COVID behavior normalizes, we expect to see share gains resume going forward, primarily at the expense of Neulasta and to see the market return to historical growth rates. The most challenging variable for us to the forecast and the one over which we have the least control is, of course price.

That said, our goal is to remain disciplined as we have been in our long-term management of ASP, while also remaining competitive. We would expect our competitors to operate in this rational manner as well. With that, I'll turn the call over to Jean..

Thank you, Chris. In addition to the brief financial overview, I will provide on the call today, you can read additional detail on our fourth quarter and year-end financial results in our press release issued earlier today and in our Form 10-K, which we plan to file with the SEC tomorrow.

We recorded $110 million of net sales of UDENYCA for the fourth quarter of 2020 compared to $124 million for the same period in 2019. The decline was primarily due to a decrease in net selling price due to increased competition partially offset by an increase in the number of units of UDENYCA sold.

For 2020, we recorded $176 million in UDENYCA net sales compared to $356 million for 2019, an increase of $120 million. The increase was primarily due to an increase in a number of units of UDENYCA sold, partially offset by a decrease in net selling price.

R&D expense rose in the fourth quarter of 2020 to $45 million compared to $35 million for the same period in 2019. The increase was primarily attributable to clinical development activities, as well as payments for certain negotiation rights for pipeline development.

For the full year 2020, we recorded $143 million in R&D expense, an increase of $49 million compared to 2019. The increase was primarily attributable to activities supporting the BLA submission for CHS-1420 and development activities related to other biosimilar product candidates.

Selling, general and administrative expense was relatively unchanged quarter-over-quarter, $38 million in the fourth quarter of 2020 versus $36 million in the same period in 2019, and year-over-year $139 million in 2020 versus $137 million in 2019.

We reported a net income of $10 million of $0.12 per share on a diluted basis in the fourth quarter of 2020 and $132 million, or $1.62 per share on a diluted basis for the full year 2020. We generated $154 million in cash flow from operations in 2020, and at year end, we had a strong balance sheet with $541 million of cash and cash equivalents.

I'll now turn the call to McDavid to provide you with expense guidance for 2021..

Thank you, Jean. In 2021, we anticipate combined R&D and SG&A expenses in the range of $310 million to $350 million, excluding upfront milestones and development expenses related to the recently announced collaboration with Junshi Biosciences, which is expected to close in the first quarter.

We Project $45 million to $50 million of stock compensation expense for the year.

The increase that we project in our operating expenses is primarily attributable to activities to advance our late stage biosimilar portfolio, including manufacturing related activities in preparation for the potential launch of CHS-1420, if approved, and development activities for IBI-305.

For UDENYCA, we are investing in marketing activities and in the development of additional presentations of the product. Before I close, on the IR front, on those that we're scheduled to present at the Cowen Healthcare Conference on March 1 at 4 PM Eastern Time, and at the Barclays Conference on March 9 at 1:15 PM Eastern Time.

I will now turn the call back to Denny..

Thank you McDavid. As you can see we're successfully positioning Coherus for sustained future revenue growth. On the biosimilar side of the business, over the course of 2021, our progress towards growing and diversifying our product portfolio will become increasingly visible.

In the next 2 years, we have the potential for approvals for biosimilars of Humira, Lucentis and Avastin. We believe that this product portfolio will deliver significant revenue growth and strong cash flows for our continued investment, immuno-oncology.

For immuno-oncology, we expect the first toripalimab BLA filing this year for nasopharyngeal carcinoma with potential approval in 2022. 15 pivotal clinical trials are underway. Additional BLAs will fall over the next 3 years for both rare and highly prevalent cancers, including non small cell lung cancer.

Several interactions with the FDA are planned for the remainder of this year as we finalize the registration strategy for these additional indications. We believe PD-1s will be the foundation for immuno-oncology therapy for the foreseeable future, increasingly used in combination with novel agents that synergistically enhance their activity.

We are excited by the option programs we have with Junshi Biosciences for their TIGIT targeted antibody and their engineered IL-2 cytokines in combination with toripalimab. We also anticipate that other companies or academic institutions may well bring forward novel compounds to evaluate in combination with toripalimab.

Strategically we see such business development activities as another way to extend our immuno-oncology franchise and to drive additional toripalimab share and to advance our new treatments for the benefit of patients.

After launch, we expect toripalimab to grow consistently into an expanding market year after year, as additional indications are added to the label. And finally, before we turn to your questions, I want to thank my good friend Jean Viret for his years at Coherus.

Jean joined before our IPO and brought his considerable capabilities to bear as we commercialized our first product. Under JV's leadership, Coherus developed a very strong finance and accounting function, and for that we are especially grateful. Jean leaves us in very good favor and we wish him the very best. Thank you JV.

I will now ask the operator to open the call to your questions..

[Operator Instructions] First question comes from the line of Chris Schott from JPMorgan. Your line is now open. You may ask the question..

Great. Thanks so much for the question. On, I guess, the first one on UDENYCA sales. Can you just provide maybe a bit more context around 1Q. I'm trying to get a sense of, it sounds like it's kind of dipping in 1Q and then kind of recovering from there.

So just maybe a little bit more color of how much of a step down should we think about relative to 4Q as we think about some of the inventory dynamics, etcetera, that you mentioned. And I just have one follow-up from there..

Thanks, Chris. Mr. Thompson, do you want to take that question about the dynamics of Q1? Make a few comments [ph]..

Yes. Yes, sure. Thanks, Denny, and thanks for your question, Chris. I think in 1Q, we're going to really see a sort of a paradigm shift here as COVID recede and the population gets vaccinated. I think what we're going to see is a dynamic where we have this huge opportunity with Neulasta Onpro.

They've got a stable share in the mid 50% range, which represents a huge reservoir of opportunity for us. And I think that we'll start to see that evolving, especially we go from Q1 to Q2. But given some of the surges that we saw in Q1 with COVID, I think that that will definitely have somewhat of an impact on Q1 for us.

Keep in mind that when we think about Onpro, it's just the big thing relative to what's actually happening in the marketplace now. We're sort of relegated to really trading share with each other, the biosimilars.

As it relates to inventory, we feel confident that inventory is going to return to normal state and already has, so we're in good shape there. I don't know if that answered your question..

Thanks, Mr. Thompson. I would just make one further remark, Chris Schott, is that last year between COVID waves we saw Onpro recede significantly between those waves. And so we are quite confident than as the vaccinations progress and people get back to normal, that we will see this happen once again, perhaps with the greater rapidity.

We think that the incentives are already priced into the market for that, and we believe that we are very well-positioned to capitalize on that as soon as COVID fades..

Great. And just my follow-up question was, when we think about the PD-1, your initial indication is a fairly small one, you've got some obviously much larger ones to follow.

So I guess how should we be thinking about that that ramp of that first indication? And how indicative or not will this initial ramp be for future larger indications? I'm trying to get a sense of basically, is this first indication that tell us much about the potential for kind of a new PD-1 in the market or do we really need to see the bigger indications before we get a better sense of how this is going to play in the marketplace versus some of the existing kind of entrenched competition?.

Great question, Chris. I believe that we are going to do very well with our execution around the first indication. One of the things that Coherus is just excellent at as you've seen in about similar business, is a very holistic execution around the Medicare Part D space, the buy and build space.

We will be the team that has the labeled indication for this orphan. It will be small, but I think that we will do very, very well with it. More importantly, we will start to be able to socialize our brand into the market. We'll be talking to the payers, the providers, the physicians and nurses, I think it's a great entry point for us as we go forward.

So I think we'll ramp up very quickly there with the PD-1, but of course, that's going to be very exciting as we start to add some additional indications. We think that there is going to be probably at least one additional indication filed per year. We prioritize the largest one [indiscernible]. So I just say stay tuned to that.

But we're fairly excited that we're going to do very well in this market..

Thank you. Next question comes from the line of Mohit Bansal from Citi. Your line is now open. You may ask the question..

Great. Thanks for taking my question. And before I begin, I mean, thank you very much, Jean for all your help during all these years. Thank you very much for that.

So nearly starting with UDENYCA, so if you look across -- if you look in last few quarters, the market share for UDENYCA has been relatively stable in this 20% to 22% range, while other biosimilars have been slowly chipping away, but not like they're not growing either. So you mentioned it is probably due to Onpro.

So from that background, how do you think about growing share and getting after COVID, what gives you confidence that you can probably take more shares from Onpro? And having an on body injector, do you think it is necessary to take more share from Onpro at this point?.

Yes, that's -- I'll take that one first and I'll let Mr. Thompson backfill. I think that if you take a look at 2020, Mohit, there was the ebb and flow of COVID across, right? There was the first wave In Q2. I think we showed some very good numbers there in the face of Q2. We began to come back and COVID came back.

As we've spoken before, COVID put the market in a bit of, I'd say, stases, very hard for new entrants to make substantial gains, you saw that with some of our competitors, easier for the entrenched competitor Amgen to leverage the inherent market advantage of the Onpro system in that market.

So, all in, we consider that we did a pretty good job maintaining share through 2020 in the face of that. We didn't have to endure quite the same price cuts that the innovator did to maintain share. Now, going forward in 2021, it sort of depends on how fast things go with the vaccinations, and so on.

Most of the stuff we've seen is that things are looking better, certainly now through Q1, I would expect that to continue in Q2. So perhaps an uptick in Q2 and on through the end of the year, we expect the quarters to grow successively as we go on through 2021.

But we think the market while I wouldn't say it's going to come to us, we think we will do very well in this market in 2021 in terms of moving forward. I think we're poised and ready..

Got it. And then ….

Chris, do you have a comment?.

Yes, I was going to say, I agree with everything that Denny says. But you know, if you think about it, we've already ran the experiment, Q1, Q2 last year, you could see that we were making significant inroads on Onpro share, because it really is a better value proposition for the providers.

We anticipate as the vaccination program expands, as the COVID spikes recede, that we're going to pick up where we left off and make significant inroads in there. We are the biosimilar market leader at 21% share and we're pretty excited about the fact that we're going to expand upon that market leadership position.

I'll just give you an anecdote as well. There's several large institutions in the Midwest and I'm out there talking to customers all the time.

And these institutions had made virtually a total conversion to UDENYCA early last year, and obviously, with the spikes in COVID and all the problems we had with COVID and the convenience of Onpro, they were forced to actually go to more Onpro, we lost share there.

And I'm happy to report right now and speaking with these customers that they've already started to move back to UDENYCA in a pretty large way. To me, that's sort of the canary in the coal mine, that's indicative of what's going to happen with accounts across the United States because it's such a compelling value proposition for our customers.

Onpro is going to go from a very -- inexpensive necessity when COVID was around to really inexpensive convenience. And most folks now, given the economic states they're in, whether it's a clinic or a hospital, they've got to be looking at the economics and UDENYCA provides the best economics for these customers..

Thanks, Mohit..

Thank you. Next question comes from the line of Salim Syed from Mizuho. Your line is now open. You may ask a question..

Great. Good afternoon, guys. And I'd like to add my thanks to Jean and congrats to McDavid for stepping into the role. A couple from me, Denny, if I can into this one, maybe housekeeping if that's possible. Denny, this one high level question for the biosimilars industry.

I'm curious, one things that I've been sort of thinking about when on this business, what was the point when you were -- you looked at -- you’ve 2 years of biosimilar launch with UDENYCA, what was the point where you decided that going after a novel strategy was the more -- the thing that you wanted to break away pretty hard from being a pure play biosimilars, which some investors thought was a plus for the story.

I'm curious to see what the point was to break away hard and say novel is kind of like the way to go. That's question one.

And then two, just on the CFO transition, just curious McDavid, if there's anything that we should expect differently as you transition into the role? And then if I can sneak in, just a quick housekeeping one that some folks have asked. On the ….

This will be three for you, Salim..

Okay. Okay. I didn't stop at two. That's [indiscernible]..

Okay. All right. So let me handle the first one. So, I don't believe there was a breaking point with respect to strategy. The company was founded with a mission of delivering savings to the health care system and greater access to the patients. That was really the key issue. We always felt very, very strongly about that.

All my co-founders that came out of Amgen and Genentech, it had worked in those shops, they all felt that this was the moral high ground and really the right thing to do. And I think that as early as 2016, we began to look at PD-1s and the evolving landscape and so on and how they looked.

Our view is that there is substantial value to be delivered to the health care system. There's good to be done by delivering on a PD-1 because they're becoming ubiquitous across immuno-oncology. So we see very, very broad utilization for our product because we can deliver a value proposition as we have with UDENYCA, right.

We have a very high quality product, very broad label. We've got a great partner, has invested heavily. I think that really the market is going to welcome us with open arms. We're going to start small, we're going to expand, but you'll see continued growth. But I don't really think that there was sort of a religious dedication to biosimilars.

Biosimilars are a way to deliver value, and that's what we saw. And so if we can leverage the capabilities across the organization, protein science, Clinreg [ph] expertise, and primarily, our commercial capabilities, which are quite strong, as you know. We think that's the way to go in terms of increasing shareholder value.

And it really wasn't any more complex than that. I'll let McDavid speak for himself as far as how he's going to follow in the large footsteps left by JV.

McDavid?.

Yes. As Denny said, we're very grateful that Jean created such a strong accounting and finance function at Coherus and I am very much looking forward to working closely with all of those team members, and with our external partners, such as EY, and others.

So I'm very pleased with the state of that organization and I'm really looking forward to being a part of that team. I'm going to be spending a lot of time also with investors and analysts as our story evolves, and it's evolving very quickly in 2021.

And connecting investors to the promise of the story as the potential approvals come along with biosimilars, Lucentis, Avastin, Humira, and also as potential approvals come through the toripalimab program, which will begin to stack up we believe very quickly.

And so there's a great deal of value that we believe we're creating with this growing and diversified portfolio of product candidates that's moving through. And I want to spend a lot of time with investors and analysts and make sure that they understand that value. So that's a big part of my job..

Yes. The -- Salim, the other point that I would give you, a sense of the announcement that we are entering immuno-oncology and PD-1 space, we've had very positive supportive outreach from our customer base in oncology. I think they're highly receptive. We've had some very large teams talk to us and we've had some conversations with them, of course.

So I think that the environment is really, really ready for this sort of an approach. It's worked very well in biosimilars and I think we're going to do quite well in the PD-1 space, frankly. I think we're the right solution at the right time..

Next question comes from the line of Balaji Prasad from Barclays. Your line is now open. You may ask a question..

Good afternoon and thanks for taking the questions. Firstly, again, Jean Viret, all the best and it was great speaking to you over the past couple of years. And coming to ….

Absolutely..

… yes. Coming to the questions, one lining of statement caught my interest where you said that your R&D spending will increase on additional presentations of UDENYCA.

So just want to understand, I would imagine that this is the onboarding device and I want to compare this with what you had said earlier recently that you will not be investing further dollars in biosimilars. So I take the base of one-off exception.

Second, I would like to understand your degree of confidence and the guiding factors for each of the three BLAs that you plan to submit this year, Lucentis, Avastin and toripalimab? I think, probably we will need some assurance on that front. I'll stop here with these two. Thanks..

Great. Well, thank you for that, Balaji. So we have previously reflected to you on calls that we're pleased with our progress on on-body. And I think you can safely assume that means that we have made investments, and those are going to show up in the financial statements and we're going to spend a little money to make progress there.

I don't think that that's quite the same as for example, committing significant funds to Phase 3 for an Eylea product or things like that, right. So I don't see any incongruity with respect to line extensions or additional presentations of UDENYCA at all.

With that, I think that's something that we've pursued, it's consistent, that products approved and so on. Now, with respect to the confidence in the BLAs, I think, first of all, I will talk about the toripalimab BLA and then I'll let Vincent Anicetti, our Chief Operating Officer, say a few more comments with these others.

With respect to the toripalimab BLA, I think that we're in very good shape. Our partner Junshi has had several conversations going back over a year with FDA on an indication, nasopharyngeal indication. They've got breakthrough status, it's an orphan and so on. So I think they've had a lot of conversations. They got very solid data, of course.

They've been approved in China. The follow on first line has been submitted in China. So I think that's buttoned up pretty well.

With respect to the BLA, I think the issue there now will be in order to get approval, they'll have to get an inspection of facilities and that facility, that product, of course, is made in China, so the FDA is going to have to find a way to get that facility inspection done in a timely fashion. It's an unmet need, and so on.

So we're hopeful that they'll sort that out. And of course, the FDA is just really been focused on the J&J vaccine, and a number of things. So we have a lot of empathy for the FDA's work. I can't believe how hard they're working, how well they're doing so. But overall, I think they'll get to this and sorted out.

Now the other BLAs are coming, of course, the 1420 BLA for Humira has been filed and accepted. I'll let Vince talk about that. The Lucentis BLA is upcoming, and Bioeq is going to file that.

I'll let Vince -- Vince, could you comment on those two for us, starting with 1420?.

Yes, thank you, Denny. So with our Humira biosimilar, CHS-1420, as we announced, the FDA accepted that for a review, which means they found everything within the BLA in order and all of the necessary information there.

We also have had a number of meetings over the last year with the FDA reviewing our development program both on the clinical and the manufacturing analytical side. We received a lot of guidance from the FDA. They gave us very good roadmap. So we're receiving questions from them now.

And I would characterize them as routine and we expect the review to go well, I would say, and hopefully get a positive decision from the FDA in December on our action date.

In regard to the Bioeq Lucentis biosimilar, in a similar fashion Bioeq has been working with the FDA very closely to resolve all of the prior issues with their prior submission, prior to their decision to withdraw.

And in a very recent meeting, in Q1, reviewing all of the work that was done to remediate those deficiencies, FDA felt that the work was done in an acceptable way and agreed that Bioeq could go forward and submit that BLA for review, which we see is a very positive sign. So that will go in, in midyear and we expect that review to go well too..

Yes.

Does that help on those questions with BLAs, Balaji?.

The question has been withdrawn [ph]. And next question, we have Jason Gerberry from Bank of America. Your line is now open. You may ask a question..

Hey, guys. Thank you for taking my questions. And I also want to extend my gratitude to JV for all the help over the years and best of luck in future endeavors. So my question, Denny, by my estimation, there's four PD-1s coming to the U.S market for lung cancer in the next 2 years under the BLA pathway.

This is a tumor that accounts for about 50% of Keytruda's revenues. So when we look at these molecules, they have comparable PFS data when you compare across histology, which to my understanding is the best way to do a cross trial [ph] comparison and not run into the issue of like post progression therapies.

So my question ultimately, how do you think this is going to impact the U.S lung cancer market? It's a big -- obviously, component of it all. These are large cap companies that have shown a historical willingness to compete on price in big categories on a net price basis.

And I noticed on your last call, you mentioned that cancer might be an underappreciated category for price sensitivity. So just kind of curious if you can get your overarching thoughts on that topic. Thanks..

Thanks for that. Thanks a lot for the question, Jason. I think that the overarching short answer is that I think that we have demonstrated in the biosimilar business that we are very fierce and competent competitors, who don't resort to the price leverage to drive share, right? We understand our customers' needs. We understand the value proposition.

We spent 2 years before we entered the launch into that market, just understanding what the customers needed and fashioning the value proposition, establishing the relationships, and then we executed on it. I think you're going to see the very same thing here.

You're going to see us go into this market and really understand what the needs of all the constituencies are in Medicare Part B, and deliver on those in a very holistic fashion. And I think that bodes well for us.

The -- I'm not sure what the size impact is these other places, and how much the need and so on, but I think that it's a market that is exactly matched to our commercial capabilities. And further, I think that we are sized accordingly to deliver on it. We're certainly going to bump up our MSL teams and our reimbursement teams and things like that.

But structurally, our organization is very well put together to scale for the challenge. So I think that we're fairly optimistic. And I think that we will be fine. I'll give you a little more detail on that. Once we get a little further into line, we actually get the filing in.

And as we proceed with our market research, another calls we will be very open with you and how we are going to talk about it, but I think that will do great. And we're not afraid -- we're obviously not afraid of competition. We're absolute fierce competent competitors..

Got it. Okay.

So basically wait till the files and before we get a better sense of what the customers really need, and what that unmet need you'll be solving for is?.

Yes, I don't think there's -- I don't know, if there's an unmet need. I wouldn't say that. But I would say there may be a -- an unmet total solution, right, that these folks want.

I will only take you back to the comments that Chris Thompson made is that when we announced that we had done this transaction, and we're moving PD-1 space, we had a outpouring of support from various quarters of the oncology, the clinical oncology teams and others, large organizations, who welcomed us to this particular market segment.

So, I think these folks are very happy that we're coming..

Yes, Denny, it's Chris. If I could add, prior to signing the deal with Junshi, we were doing a lot of outreach, trying to understand what providers, what physicians we are looking for as it relates to PD-1. And in doing so they were very excited that we were entering this market. I mean, in oncology, folks buy from whom they trust and who they know.

And we've established a great relationship with oncologist as it relates to UDENYCA, and we just got a sense that there is a lot of excitement for entering this market..

Yes, the other point that I would make is that we're proficient at competing in markets where there is not a significant amount of therapeutic differentiation, right. So this is our wheelhouse. You can't get any more than biosimilars with -- in terms of the lack of therapeutic differentiation.

As you pointed out, you can look at PFS across these various products and you see very, very similar readouts, very similar mechanism of action, and so on. So I think this plays well for our strength..

Thank you. And the next question comes from the line of Greg Gilbert from Truist Securities. Your line is now open. You may ask a question..

Great. Thanks. Two [indiscernible] up front. My first question is about Humira.

I'm curious how transferable and applicable you think the UDENYCA example as to Humira, given the different sort of channels and incentives in the system, maybe talk about difference in out of pocket at the patient level? I'm not so sure exactly what saving the system money means in one case versus the other, as the middlemen seem to welcome new companies because they can make more money on that.

But curious about the out of pocket at the patient level between those two? And then, Denny, I was intrigued by your comments in the last call about the potential for biosimilars to Keytruda not to show up in 2028. And then it may be harder than people think to get there.

If you were wrong about that, and there are biosimilars to Keytruda in 2028, is that contemplated in how you're working on your development strategy? And does your development strategy include co-formulations as it appears Coherus [ph] is driving a lot in that direction? Thank you..

Yes. I think those are two great questions. So first of all, under the circumstance that biosimilars to Keytruda show up in '28 or '29, 4 or 5 years earlier than we have, I think that's fine. I think that these PD-1s really need to be put together, as you point out with combinations.

This is the whole reason why we have the combinations available to us, the TIGITs, the engineered IL-2s and others from our agreement with Junshi.

And this is also why we [indiscernible] on this call that we are open to combinations with other parties who come to us either institutions or small companies and others who want to do studies with us combination. So we think in the period from 2025 forward, it's going to be less issue of monotherapy than it will be an issue of combinations.

We think that we have a very, very good PD-1 here that we have partnered with Junshi. And we think that we will be very successful with that. So the base therapy is PD-1. Yes, the biosimilars might show up, but I think that you have to have the combinations, and we've got a very robust pipeline of combos coming and we welcome others.

With respect to Humira and the copays and with the patients and so on, I don't want to say too much because we're really in position of working forward our strategy, and I don't want to show our strategic cards very much with Humira. But I would make a couple of points.

The first point that I would make is that the presumption has been for some time among some folks that you wouldn't get switch patients. That -- a patient that’s stable on Humira would stay on Humira until they naturally go on to another therapy or whatever. And then your market penetration would be largely slowed by the need for fresh starts.

We believe that large high control payers by the time this comes around in '23 will embrace, putting biosimilars high up on the formulary, they may have to step through that. We think that they will probably force switches in some case, because there is just so much savings. And I think there's disintermediation available there.

And I think that we're going to be prepared to serve very large parts of the market with supply guarantees, high quality product, a state-of-the-art auto injector, a non-sting formulation, we've looked at all this. I think that we are going to do very well in this space because of that.

Again, I think the way to be successful in these businesses is to talk to your customers to understand their needs. And so we are in that process now and understanding just what we have to do, vis-a-vis the payers, and of course, the patients and the providers to do that.

But I think that we put a stake in the ground here that we think we can take 10% market share at least, we're going to gear up for that our manufacturing and so on. So we think this is going to be a great market and there's significant savings to be delivered in the Humira side of the business..

Thank you. And the next question comes from the line of George Yordanov from Cowen & Company. Your line is now open. You may ask a question..

Hey, guys. Thank you so much for taking my question. So, I guess, as it relates to Lucentis and PD-1, if you think about the opportunity and your expertise, UDENYCA likely has somewhat different institutional engagement versus sales force and payer effort requirements.

Could you characterize for us how the promotional effort and payer engagement might differ or be similar with Lucentis and the PD-1 asset? And then, on the Junshi collaboration, we notice that the majority of clinical trials they're running are China based.

Would it be possible to use the data from these trials for FDA approvals in the U.S? Or would you have to run smaller U.S based trials, especially for those larger indications?.

Okay. That's a -- let me unpack a little bit of that. Let me take the last one first.

So I think when you consider trials done anywhere in the world, and the issue is less of histology driven genetics, which is sometimes the case, but what you really want to watch out for, number one, is do you have the same standard of care, right? And then do you have a relevant patient population that is transferable? So Junshi has taken a very good look at this.

We feel that lung, NPC, esophageal, urethral, triple-negative breast, all these indications transfer very, very well. And we think that those pivotal clinical trials will transfer the United States.

Now, the Junshi and ourselves are going to spend our time to the rest of 2021 here, talking to the FDA about what the registration strategies are on an indication by indication basis in NC [ph]. But I would not assume that there's additional clinical work that needs to be done specifically with things like NPC is fine.

But if you do run into some histology driven genetics, and you may have to do something else, but by and large, I think that these are high quality trials that are transferable.

Now to your other question with respect to with the Lucentis biosimilar, and then secondly the PD-1 biosimilar, I'll first take the PD-1 biosimilar and I'll point that out with respect to Medicare Part B, and then talk a little bit -- I'll let Chris Thompson talk about Lucentis.

So we think that the PD-1 biosimilar will really scale our existing oncology sales force, call points, GPO contracts, relationships, payers, as all those things will line up very, very well with the PD-1. So we see that as a very synergistic product portfolio mix. And that's why we're optimistic about that.

And we've heard from all of these parties so far as we've gone forward. So excellent fit, the PD-1 with UDENYCA into that market.

Chris, do you want to talk a little bit about the Lucentis market structure, Medicare Part B [indiscernible] and some of the subtleties there?.

Yes, thanks, Denny.

Obviously, we've been very successful being the market leader with UDENYCA, being that it's a Part B drug and our capabilities around that are recognized by our customers as being outstanding and understanding that market, understanding the importance of ASP, understanding their business models on how they generate revenue within their clinics.

We think all of this expertise is transferable to Lucentis. As a matter of fact, two days ago, we're part of presenting to a focus group of retinal specialists and talking with them and trying to understand their business models. They're very excited about Coherus entering with a biosimilar in the future.

We did get some good points from them on things we want to consider in our value proposition with that specialty. And we pride ourselves in being able to really shape great value for whatever specialty we enter, but if you think about the skills that are necessary to be successful here, we have those, we have that experience in Part B.

And the same will relate to our payer team who works with on the medical benefits side, on the commercial side, right? It's the same business as UDENYCA. And we have those relationships in place and we believe that they're very anxious to have that type of competition in the marketplace..

Yes. Hey, Chris, just one more thing.

Can you comment on the applicability of Coherus complete in our reimbursement efforts and how well those transfer?.

Yes, I'm glad you asked that, Denny.

That was one of the things that struck a chord the other night when we were talking with these [technical difficulty] and healthcare professionals, retinal specialists is the fact that we have Coherus complete, which is our hub for patient services, which provides everything from copay assistance to indigent patient care to benefit verification to prior authorizations.

When you put that whole package together, it works nicely into the workflow of a retinal specialist office, and take some of the burden away from them to have to manually do all this. We've actually streamlined most recently our benefits verifications and prior authorizations, so they can do it electronically.

So this really takes a lot of time, burden away from their office staff and helps them to be more efficient. These customers are always very excited about that workflow is important..

Okay. Thank you..

Thank you. Next question comes from the line of Douglas Tsao from H.C. Wainwright. Your line is now open. You may ask a question..

Hi, good afternoon, and just want to wish JV well, and join everybody else in saying how great it's been working with him. Denny, in terms of the Junshi partnership, I was just curious, in the last call you did make some comments in terms of some of the characteristics of the PD-1 that interested you.

I was just wondering if you're in position to provide any color in terms of the TIGIT as well as the IL-2, in terms of how those molecules might be -- maybe differentiated the wrong way, but if there are any unique characteristics that make you think that particularly appealing?.

Thanks for the question, Doug. I'm going to hedge a little bit on this because we have not yet cleared Hart-Scott Rodino. And we'll probably have a little bit more to say about this as additional data is generated later in the year.

But I think that there's precedents in literature, if you look at the TIGITs, and there's synergy, for example, in lung with PD-1s, or if you look at the engineered IL-2s and so forth. You can dig out some -- lot of data along these lines.

I would point you to that or if you want us to refer you to some of those publications, I can have one of my team members take that on and McDavid can point that to you.

But I think there is a plethora of complimentary combination products in development at Junshi and I think particularly what's attractive about the transaction structure is that our expenditures are limited to $25 million per product per year for any of these products.

So that gives us a fair amount of P&L predictability as we go forward, particularly over the next couple of years while we're watching the dollars. And I think that really sort of puts us in a position where we can participate in global development programs with these assets.

And still, though, we have cost control, which of course is attractive to us and our investors. So I kind of have to stop there. But the next call, I think we'll have a little more to say to you about that and we'll -- in the interim, we'll be happy to forward some scientific literature off to you..

Okay. That'd be really helpful.

And then just as a follow-up in terms of the Lucentis opportunity, at what point now that we're nearing BLA submission, should we think about any sort of increase in SG&A, or the commercial infrastructure ahead of that launch? And will it be necessarily noticeable, or is this something that you can -- that kind of accomplish pretty efficiently.

And so, should be not too impactful, especially in the context of the hope that we can start to see UDENYCA growing again next year. Thank you..

Yes, thanks for that one. I would say not too impactful, I think to use the right term. So we have significant investments already in our information technology, infrastructure, dashboard systems, readouts, we will certainly need a marketing manager here and there to focus on things. We haven't really decided on what the footprint needs to be.

But we've talked before about the concentration of accounts, a number of people, maybe it's 20 to 25 folks, something along that order. But we haven't really come down on how exactly we need to do that. I will say that if we get the filing in mid -- around here midyear or so as we've said, we'll give you a little more color on that.

But in any case, we don't think there's going to be a substantial ramp up on the expense line for this. And as you heard from Chris Thompson, we've already started outreach to the community of ophthalmology, understanding what the value proposition needs to look like. And I think fashioning the value proposition is the most important thing right now.

So we're focused there..

And the last question comes from the line of Balaji Prasad from Barclays. Your line is now open. You may ask a question..

Thank you. Sorry, I just wanted to get back to Denny, if you're -- when you're asking me for UDENYCA question. The third BLA that I wanted to -- that I mentioned was Avastin and wanted to get your sense of confidence on that? Incidentally I found these responses [indiscernible] very useful. Thank you..

Oh, thanks for that. I think that we disclosed today that we're underway with the three-way PK study. We got slowed down on that one a little bit last year with COVID. We did that deal and then as soon as Chinese New Year was over, COVID, hit, everything kind of grind to a halt, the FDA pivoted and so that slowed things up.

I think it's fair to say that things were running along fairly well at this time making good progress on the trial. So we'll give you update on the next call on that one, when we have a little more clarity, but that's about where it is. But that was one of these things last year where we -- it was COVID -- just COVID impact on that one.

But it's clipping on fairly well now..

Understood. Thank you..

All right. Thank you..

No further questions at this time, I will now turn the call over to Mr. McDavid Stilwell for any closing remarks..

Thank you everybody for joining us on the call today. I look forward to speaking to you again in the near future..

Thanks, guys. Bye, bye..

Thanks. Chris Thompson Thank you..

Thanks. Thank you, ladies and gentlemen. That concludes today's conference call. Thank you all for participating. You may now disconnect..