Coherus BioSciences - Earnings Call - Q4 2020

Transcript

Speaker 0

Ladies and gentlemen, thank you for standing by, and welcome to the Fourth Quarter and Full Year twenty twenty Coherus Bioscience Conference Call. At this time, all participants' lines are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time. I would now like to turn the conference over to your host today, Mr. McDavid Sobel.

Sir, please go ahead.

Speaker 1

Thank you. Good afternoon, everyone, and thank you for joining us. We issued a press release earlier announcing our twenty twenty 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 and D and SG and 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 09/30/2020. 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 Lanphier, Chief Executive Officer Jean Viret, Chief Financial Officer Vince Anasetti, Chief Operating Officer and Chris Thompson, Executive Vice President of Sales. I'll now turn the call over to Denny.

Speaker 2

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 McDavid will discuss fourth quarter and full year 2020 financial results as well as expense guidance for 2021. We'll then open the call for questions.

Certainly, COVID-nineteen 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 twenty twenty one, we expect that as COVID recedes, we will reserve market share growth, largely coming at the expense of Neulasta Zonpro. We see 2021 as a year of fundamental transition and an inflection point for Gloyeres. We are extending our mission and expanding our late stage pipeline to include immuno oncology with our recently announced collaboration with Yunshi Biosciences for US and Canada rights to their PD-one inhibitor, Toripalumab. The transaction is projected to close later this quarter.

Toripalumab is being 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, Torapalumab was approved in China for this indication, and regulatory authorities there have also begun a review of Toropalumab for first line treatment of nasopharyngeal carcinoma. Over the next few years, we expect this 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 torapalumab in 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-two cytokine, as well as certain negotiation rights to two other immuno oncology molecules. Once the transaction is closed, Junji Biosciences will purchase $50,000,000 of Cohera's 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, Toropalumab, 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-nineteen headwinds through most of 2020.

UDENYCA net sales of $476,000,000 for 2020 drove $154,000,000 in cash flow from operations for the year. Chris will describe UDENYCA performance in more detail in just a few moments for you. First, though, let me review recent pipeline progress in our biosimilar business. With respect to our Humira biosimilar, CHS-fourteen 20, 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 payer 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 BioEc.

The FYB-two zero one BLA is on track for a mid year twenty twenty one 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 $6,000,000,000 anti VEGF ophthalmology market.

Regarding IBI-three zero five, our Avastin biosimilar product candidate in partnership with Innovent, we have initiated the 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 $28,000,000,000 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 advancing biosimilar pipeline, together with atoropalumab, demonstrates solid progress on this strategy as we pursue the $25,000,000,000 PD-one 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?

Speaker 3

Thank you, Denny. 2020 was a successful year for UDENYCA despite the challenges of COVID. In the fourth quarter, we delivered $110,000,000 in net sales, driven by an increase in units that was offset by a 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 and 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 OnBody 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-nineteen, seasonal impacts to gross to net and a depletion of the inventory that 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.

Speaker 4

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 ks, which we plan to file with the SEC tomorrow. We recorded $110,000,000 of net sales of UDENYCAL for the 2020 compared to $124,000,000 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 $476,000,000 in UDENYCA net sales compared to $356,000,000 for 2019, an increase of 120,000,000.

The increase was primarily due to an increase in the number of units of UDENYCA sold, partially offset by a decrease in net selling price. R and D expense rose in the 2020 to $45,000,000 compared to 35,000,000 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 $143,000,000 in R and D expense, an increase of $49,000,000 compared to 2019. The increase was primarily attributable to activities supporting the BLA submission for CHS-fourteen 20 and development activities related to other biosimilar product candidates.

Selling, general and administrative expense was relatively unchanged quarter over quarter, 38,000,000 in the 2020 versus $36,000,000 in the same period in 2019 and year over year $139,000,000 in 2020 versus $137,000,000 in 2019. We reported a net income of $10,000,000 or $0.12 per share on a diluted basis in the 2020 and $132,000,000 or $1.62 per share on a diluted basis for the full year 2020. We generated 154,000,000 in cash flow from operations in 2020 and at year end, we had a strong balance sheet with $541,000,000 of cash and cash equivalents. I'll now turn the call to McDavid to review expense guidance for 2021.

Speaker 1

Thank you, Jean. In 2021, we anticipate combined R and D and SG and A expenses the range of $310,000,000 to $350,000,000 excluding upfront milestone and development expenses related to the recently announced collaboration with Junshi Biosciences, which is expected to close in the first quarter. We project $45,000,000 to $50,000,000 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-fourteen 20, if approved, and development activities for IBI-three zero five. 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, I'll note that we're scheduled to present at the Cowen Healthcare Conference on March 1 at four p. M. Eastern Time, and at the Barclays Conference on March 9 at 01:15 p. M. Eastern Time.

And now I'll turn the call back to Denny.

Speaker 2

Thank you, McDavid. As you can see, we are 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 two 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 in immuno oncology.

For immuno oncology, we expect the first toripalumab BLA filing this year for nasopharyngeal carcinoma with potential approval in 2022. 15 pivotal clinical trials are underway. Additional BLAs will follow over the next three 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-two cytokine in combination with Toropalimod. We also anticipate that other companies or academic institutions may well bring forward novel compounds to evaluate in combination with Toripalumab. Strategically, we see such business development activities as another way to extend our immuno oncology franchise and to drive additional Toropalumab share and to advance our new treatments for the benefit of patients. After launch, we expect Toropalumab 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 Veret for his years at Coherus.

Jean joined before our IPO and brought his considerable capabilities to bear as we just developed a very strong finance and accounting function. And for that, we are especially grateful. John leaves us in very good favor and we wish him the very best. Thank you, J. B.

I'll now ask the operator to open the call to your questions.

Speaker 0

Thank you. First question comes from the line of Chris Schott from JPMorgan. Your line is now open. You may ask the question.

Speaker 5

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 just 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 also have one follow-up from there.

Speaker 2

Thanks, Chris. Mr. Thompson, do you want to take that question about the dynamics of Q1, make a few remarks?

Speaker 3

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 recedes 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-fifty percent range, which represents a huge reservoir of opportunity for us.

And I think that we'll start to see that evolving, especially as 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 a 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 it already has.

So we're in good shape there. I don't know if that answered your question.

Speaker 2

Thanks, Mr. Thompson. Would just make one further remark, Krishat, is that last year between COVID waves, we saw Onpro recede significantly between those waves. And so we're quite confident then as the vaccinations progress and people get back to normal, that we will see this happen once again, perhaps with 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.

Speaker 5

Great. And just my follow-up question was, when we think about the PD-one, 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 ramp of that first indication? And how indicative or not will this initial ramp be for future larger indications?

I'm just trying to get a sense of basically is this first indication going to tell us much about the potential for kind of a new PD-one 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?

Speaker 2

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 the biosimilar business, is a very holistic execution around the Medicare Part B space, the buy and bill space. We will be the team that has the labeled indication for this orphan. It will be small but I think they will do very, very well with it.

More importantly, we'll start to be able to socialize our brand into the market. We'll be talking to the payers, the providers, the physicians, the 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-one. But of course, what's going to be very exciting is we start to add some additional indications.

We think that there's going to be probably at least one additional indication filed per year. We prioritize the largest ones such as lung. So I'd just say stay tuned to that. But we're fairly excited that we're going to do very well in this market.

Speaker 0

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

Speaker 6

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

So if you look across if you look in last few quarters, the market share for Udanica has been relatively stable in this 20%, 22% range, while other biosimilars have been slowly chipping away, but not like they are not growing either. So you mentioned it is probably due to Onpro. So from that background, how do you think about growing here? And can you after COVID, what gives you confidence that you can probably take more share from Onpro? And having an Onbody injector, do you think it is necessary to take more share from Onpro at this point?

Speaker 2

Yeah, I'll take that one first and I'll let Mr. Thompson backfill. I think that if you take a look at twenty twenty MOHEIT, 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 then COVID came back. As we've spoken before, COVID put the market in a bit of, I'd say, stasis, 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'll do very well in this market in 2021 in terms of moving forward. I think we're poised and ready.

Speaker 7

Got it. Chris,

Speaker 2

do you have a comment?

Speaker 3

Yes. I was going to say, I agree with everything that Denny says. But if you think about it, we've already ran the experiment. Q1, Q2 of 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 in 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 an expensive necessity when COVID was around to really an expensive 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.

Speaker 2

Thanks, Mohit.

Speaker 0

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

Speaker 7

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, then just one maybe housekeeping, if that's possible. Denny, just one high level question for the biosimilars industry.

I'm curious, one the things that I've been sort of thinking about on this business, what was the point when you were you looked at you have two 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. Well, I'm just 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 Eylea.

Speaker 2

This will be three for you, Celine. Okay,

Speaker 7

I can stop at two. No worries.

Speaker 2

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 the mission of delivering savings to the healthcare 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 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 in the evolving landscape and so on and how they looked. Our view is that there is substantial value to be delivered to the healthcare system.

There's good to be done by delivering on a PD-one 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 who 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 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?

Speaker 1

Yeah. As Denny said, we are 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 and others. So I'm very pleased with the state of that organization and 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 Toripalumab 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.

Speaker 2

Salim, the other point that I would give you is since the announcement that we were entering the immuno oncology and PD-one 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-one space, frankly. I think we're the right solution at the right time.

Speaker 0

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

Speaker 8

Hi, good afternoon. Thanks for taking the questions. Firstly, Jean Marie, all the best. And it was great speaking to you over the past couple of years. Coming to the questions, one line in your statement caught my interest where you said that your R and D spending will increase on additional presentations of UDENYCA.

So I just want to understand that I would imagine that this is the on body device. And I want to compare this with what you had said earlier recently that you would not be investing further dollars in biosimilars. So, take that there's a one off exception. Second, I would like to understand your degree of confidence on the gating factors for each of the three BLAs that you plan to submit this year, Vicente, Avastin and Toripalumab. I think probably will need some assurance on that front.

I'll stop you with these two. Thanks.

Speaker 2

Great. Well, thank you for that, Balaji. So we have previously reflected to you on calls that we're pleased with our progress non 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 a phase three for an EYLEA product or things like that. So I don't see any incongruity with respect to line extensions or additional presentations of UDENYCA at all. I think that's something that we pursued and it's consistent that product's approved and so on. Now, with respect to the confidence in the BLAs, I think first of all, I'll talk about the Toripalumab BLA.

And then I'll let Vince Anasetti, our Chief Operating Officer, say a few more comments with these others. With respect to the zuropalumab 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 that 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've 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.

That facility, that product of course is made in China. So the FDA is going 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 has just really been focused the J and 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 and how well they're doing. But overall, I think they'll get to this and sort it out. Now, the other BLAs are coming. Of course, the fourteen twenty BLA for Humira has been filed and accepted.

I'll let Vince talk about that. The Lucentis BLA is upcoming. And BioEc is going to file that. Vince, could you comment on those two for us, starting with $14.20?

Speaker 9

Yes, thank you, Denny. So with our Humira biosimilar, CHS-fourteen 20, as we announced, the FDA accepted that for 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 a very good roadmap.

So we are 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 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 BioAcc could go forward and submit that BLA for review, which we see as a very positive sign. So that will go in, in midyear. And we expect that review to go well, too.

Speaker 2

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

Speaker 0

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

Speaker 10

Hey, guys. Thank you for taking my questions. And, also want to extend my gratitude to JV for, all the all the help, over the years, best of luck in future endeavors. So my my question, Adani, by my estimation there's four PD-1s coming to The U. S.

Market for lung cancer in the next two 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 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, you know, obviously component of it all. These are large cap companies that, you know, 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

Thanks.

Speaker 2

Thanks a lot for the question. 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 lever to drive share. We understand our customers' needs. We understand the value proposition. We spent two years before we entered and launched into that market just understanding what the customers needed in 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. I'm not sure what the size impact is, these other places, and how much they 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 buff 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'll be fine.

I'll give you a little more detail on that once we get a little further into lung, we actually get the filing in. And as we proceed with our market research on other calls, we'll be very open with you on how we want to talk about it. But I think that we'll do great. And we're not afraid we're obviously not afraid of competition. We're absolute fierce, competent competitors.

Speaker 10

Got it. Okay. So basically wait until the file's in before we get a better sense of what the customers really need and what that unmet need you'll be solving for is?

Speaker 2

Yeah. I don't think there's a I don't know if there's an unmet need. I wouldn't say that. But I would say there may be an unmet total solution that these folks want. I will only take you back to the comments that Chris Thompson and I made.

When we announced that we had done this transaction, we're moving PD-one space, we had an outpouring of support from various quarters of the oncology, the clinical oncology teams and others, large organizations, who welcomed us to this particular So I think these folks are very happy that we're coming.

Speaker 3

Danny, it's Chris. If I could add, prior to signing the deal with Junchi, we were doing a lot of outreach, trying to understand what providers, what physicians were looking for as it relates to PD-one. And in doing so, they were very excited that we were entering this market. In oncology, folks buy from whom they trust, and who they know. And we've established a great relationship, with oncologists as it relates to UDENYCA.

And we just got a sense that there is a lot of excitement for our entering this market.

Speaker 2

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. So this is our wheelhouse. You can't get any more than biosimilars in terms of 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 strengths.

Speaker 0

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

Speaker 11

Great, thanks. Have two. I'll ask them upfront. My first question is about HUMIRA. I'm curious how transferable and applicable you think the UDENYCA example is 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, 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 Merck is driving a lot in that direction? Thank you.

Speaker 2

Yeah, think those are two great questions. So first of all, under the circumstance that biosimilars to Keytruda show up in '28 or '29, four or five 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, others from our agreement with Jun Shi. And this is also why we've seen 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 on combinations.

So we think in the period from 2025 forward, it's going to be less an issue of monotherapy than it will be an issue of combinations. We think that we have a very, very good PD-one here that we have partnered with Junxi. And we think that we'll be very successful with that. So the base therapy is PD-one. Yeah, 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 co pays and with the patients and so on, I don't want to say too much because we're really in a position of working forward 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 2023, 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 cases, 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 nonstain 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 in 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 Umayra side of the business.

Speaker 0

Thank you. We have the next question, which comes from the line of Georgie Yardenell from Cowen and Company. Your line is now open. You may ask your question.

Speaker 12

Hey, guys. Thank you so much for taking my question. So, yes, as it relates to Los Santos and PD-one, if you think about the opportunity and your expertise, UDENYCA likely has somewhat different institutional engagement versus Salesforce and payer effort requirements. Could you characterize for us how the promotion effort and payer engagement might differ or be similar with Nucyntis and the PD-one asset? And then on the Junshi collaboration, we noticed 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 US? Or would you have to run smaller US based trials, especially for those larger indications?

Speaker 2

Okay. 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, 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 Jun 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 to The United States.

Now Jun Shi and ourselves are going to spend our time through the rest of 2021 here talking to the FDA about what the registration strategies are on an indication by indication basis and see. 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, then 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 the Vicente's biosimilar and then secondly, the PD-one biosimilar.

I'll first take the PD-one biosimilar and I'll part that out with respect to Medicare Part B. And then talk a little bit, I'll let Chris Thompson talk about the Lucentis. So we think that PD one biosimilar will really scale our existing oncology sales force, call points, GPO contracts, relationships, payer strategy, all those things will line up very, very well with the PD-one. 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, excellent fit, the PD-one with UDENYCA into that market. Chris, do you want to talk a little bit about the Lucentis market structure, Medicare Part B buy and bill and some of the subtleties there? Yes. Thanks,

Speaker 3

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.

Speaker 2

Hey, Chris, just one more thing. Can you comment on the applicability of Coherence Complete in our reimbursement efforts and how well those transfer?

Speaker 3

Yeah, 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 end health care professionals, retinal specialists, is the fact that we have Coherence Complete, which is our hub for patient services, which provides everything from co pay 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's 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

Speaker 2

lot of

Speaker 3

time, burden away from their office staff and helps them be more efficient. These customers are always very excited about that. Workflow is important.

Speaker 2

Okay. Thank you.

Speaker 0

Thank you. Next question comes from the line of Douglas Chow from H. C. Wainwright. Your line is now open.

You may ask your question.

Speaker 13

Hi, good afternoon. And just want to wish J. V. Well and join everybody else in saying how great it's been working with them. Know, Denny, you know, in terms of the, Junji partnership, was just curious on the last call you did make some comments in terms of some of the characteristics of the PD-one that interested you.

I was just wondering if you were in a position to provide any color in terms of the TIGIT as well as the IL-two, in terms of how those molecules might be differentiated the wrong way, but if there are any unique characteristics that made you think that were particularly appealing.

Speaker 2

Thanks for the question, Doug. I'm going hedge a little bit on this because we have not yet cleared Hartz got 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 precedence in the literature if you look at the TIGITs and their synergy, for example, in lung with PD-1s, or if you look at the engineered IL-2s and so forth. You can dig out a 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 complementary combination products in development at Junxie. And I think particularly what's attractive about the transaction as structured is that our expenditures are limited to $25,000,000 per product per year for any these products. That gives us a fair amount of P and L predictability as we go forward, particularly over the next couple of years while we're watching the dollars. And I think that really 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. In the interim we'll be happy to forward some scientific literature off to you.

Speaker 13

Okay, that would 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 and A or the commercial infrastructure ahead of that launch? And will it be necessarily noticeable? Or is this something that you can 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.

Speaker 2

Yeah, thanks for that one. I would say not too impactful. I think you used the right term. We have significant investments already in our information technology infrastructure, dashboard systems, readouts. We'll 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 and 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 around mid year or so, as we 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. I think fashioning the value proposition is the most important thing right now. So we're focused there.

Speaker 0

Thank you. Last question comes from the line of Balaji Prasad from Barclays. Your line is now open. You may ask your question.

Speaker 8

Thank you. Sorry. I just wanted to get back to you, Danny, when you're asking me if you had answered the questions. The third BLA that I wanted to that I mentioned was Avastin, And I wanted to get your sense of confidence on that. Incidentally I found the responses in the other two very useful.

Thank you.

Speaker 2

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 ground to a halt, the FDA pivoted and so that slowed things up. I think it's fair to say that things are 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 just COVID impact on that one. But it's clipping along fairly well now. Thank you.

All right, thank you.

Speaker 0

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

Speaker 1

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

Speaker 2

Thanks, guys. Bye bye.

Speaker 4

Thanks.

Speaker 3

Thank you.

Speaker 0

Thank you. Ladies and gentlemen, that concludes today's conference call. Thank you all for participating. You may now disconnect.