Good day, and thank you for standing by. Welcome to the Third Quarter 2021 Coherus Biosciences Conference Call. [Operator Instructions]. I would now like to hand the conference over to your speaker today, McDavid Stilwell. Please go ahead.

Thank you. Good afternoon, everyone, and thank you for joining us. We issued a press release earlier announcing our 2021 third quarter results. This 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, 2021, that we filed earlier this afternoon. 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 model. With me on today's call are Denny Lanfear, CEO of Coherus, Paul Reider, Executive Vice President of Commercial Operations and Market Access; and Chris Thompson, Executive Vice President of Sales. I will now turn the call over to Denny.

Thank you, McDavid, and thank you all for joining us this afternoon. I'm pleased today to report on our recent achievement of key milestones, driving near-term growth of our commercial product portfolio. We now have 3 BLAs under FDA review and expect to pursue multiple additional FDA applications. In 2022, based on recently reported positive clinical data, we expect within a year to have 4 products approved, within 2 years to have 5 products launched and driving significant revenue growth to fund our expansion in oncology. Since our last conference call in August, we reported a series of significant achievements towards this goal. First, the positive data from the UDENYCA on-body injector clinical trial, which is expected to enable a 2022 submission of a prior approval supplement to the UDENYCA BLA. Following the 10-month review period for the OBI submission, we plan to launch directly upon approval. The FDA has accepted the BLA for our biosimilar Lucentis CHS-201 and assigned a target action date of August 2022. We plan to launch directly upon approval. The FDA review of the BLA for our biosimilar HUMIRA, CHS-1420, is proceeding well and advancing towards the December 2021 action date. We plan to launch in July 2023. The FDA also accepted the toripalimab BLA for advanced nesolparongeo carcinoma, including in combination with chemotherapy for first-line in its mild therapy for second line and greater and granted priority review with a target action date of April 2022. We plan to launch toripalimab directly upon approval next year. Recently presented positive data from the esophageal squamous cell carcinoma Phase III clinical trial are expected to enable the submission of the toripalimab BLA supplement in 2022. Positive progression-free survival data from the Phase III clinical trial evaluating toripalimab in non-small cell lung cancer were presented in September.…

Thank you, Denny. UDENYCA net sales were $83 million in the third quarter, down 6% from the second quarter. This was driven by an 8% decline in units, partially offset by a favorable shift in segment mix. The market share declined from 19% in the second quarter to 18% in the third quarter with share loss being largely limited to 340B hospitals. Our lowest margin business or new entrants have been gaining share. Our share in clinics grew, and we held share in non-340B hospitals. As we saw in each of the last 2 years, the pegfilgrastim market declined modestly in the third quarter, and we expect a return to low single-digit market growth in the fourth quarter. Until COVID recedes more broadly, there will continue to be a short-term advantage favoring the originators on-body device, which retains 50% of the overall market. We continue to believe that in the long term, taking share from Onpro will be a source of growth for biosimilars and especially for UDENYCA. The other element beyond our control is the level of price erosion precipitated by our competitors. We seek to be good stewards of our ASP as we believe relative price stability benefits our customers. Our strategy is to maximize long-term UDENYCA revenues. Now I'd like to talk about commercializing our pipeline. We are now preparing for the launch of 2 new products in 2022, toripalimab for nasalpharyngeal carcinoma and CHS-201 or biosimilar Lucentis. We expect to launch both products directly upon approval. Nasalpharyngeal carcinoma is a rare cancer, where currently there are no PD-1 inhibitors that are FDA approved for use. Toripalimab not only has the potential to be the first and only PD-1 inhibitor indicated for this tumor type but to also establish a new first-line standard of care. Our oncology commercial capabilities have been built to scale and the toripalimab effort will be efficiently integrated into our existing infrastructure. Launch preparations are underway and progressing well. With respect to our Lucentis biosimilar, our FDA action date of August 2022 will allow us to launch and compete early in the biosimilar market from Asia. The branded Lucentis market is expected to be $1.3 billion in 2021. Our launch planning is underway and progressing well, and we look forward to competing in this large market. We intend to launch with a dedicated ophthalmology sales team while leveraging our existing key account, market access and patient support capabilities from oncology. I'll now turn the call over to McDavid to review the quarter's financial results.

Thanks, Paul. The details of our financial results are in the press release and in the 10-Q we filed this afternoon. So I'll now focus on a few highlights. For the third quarter of 2021, we reported a $38.5 million net loss on a GAAP basis. Cash flow from operating activities was $13.7 million for the third quarter of 2021. As detailed earlier in the call, net product revenue was $83 million, a decrease from $88 million in UDENYCA net sales recorded the prior quarter. Wholesaler inventory remained within the normal range. In the first quarter of 2021, we depleted the inventory manufactured and expensed prior to UDENYCA approval. And since then, per unit acquisition costs are fully reflected within COGS. Therefore, cost of goods as a percent of net revenue has increased from the year-ago quarter. The third quarter 2021 COGS was also impacted by a write-off of $5.2 million related to inventory that did not meet acceptance criteria. We expect COGS as a percentage of net sales to decline in the fourth quarter to the mid-teens including a mid-single-digit royalty we owe through mid-2024. In the long run, starting in 2024, we expect UDENYCA gross margins to return to 90% or higher as we realize the benefits of a significant manufacturing process improvements and royalty expiration. Research and development expenses for the third quarter of 2021 were $54.1 million compared to $38.9 million for the same period in 2020. The increase reflects cost to advance our late-stage pipeline. Recall that we expect to bring 4 additional products to market over the next 2 years and also the on-body injector presentation of UDENYCA. And we are investing this year in activities such as regulatory affairs and manufacturing scale up for CHS-1420, clinical development and BLA filings for toripalimab and the clinical trial for CHS-305 and one for UDENYCA on-body injector. Selling, general and administrative expenses were $39.9 million in the third quarter of '21 as compared to $32 million in the year-ago quarter. The increase was driven primarily by higher UDENYCA commercialization activities as well as stock-based into other compensation expense. We ended the quarter with cash, cash equivalents and marketable securities of $468.7 million compared to a balance of $454.5 million at June 30, 2021. We are maintaining our full year guidance for R&D and SG&A expense of $370 million to $400 million, excluding the first quarter upfront payment to Junshi Biosciences. And this range includes approximately $50 million to $55 million in stock-based compensation expense. I'll now turn the call back to Denny for closing remarks.

Thanks, McDavid. The next 12 months will be exciting time at Coherus for the potential for additional clinical data for toripalimab, a new tumor types, a growing immuno-oncology pipeline, FDA action and multiple new product candidates and anticipated commercial launches for both toripalimab and CHS-201 or Lucentis biosimilar. In January, we are planning to host first annual Coherus pipeline and business review meeting in New York City. With progress in our pipeline and our strategic expansion into oncology, our business is rapidly evolving. We plan to provide a deep dive into the various elements of our business and give investors and analysts an opportunity to hear from additional members of the team. We will provide additional information a little closer to the date, and we look forward to seeing you there. I'll now ask the operator to open the line for questions. Operator?

[Operator Instructions]. Your first question comes from the line of Salim Syed of Mizuho. .

Just a couple for me, one on the UDENYCA on-body injector and then one on TIGIT if I can. So on the on-body injector, guys, congrats on the progress. Just curious how you guys are thinking about the revenue profile here for UDENYCA. If you're -- if we should be expecting a bimodal peak obviously, consensus, is it modeling a bimodal peak right now? Just curious how you're thinking about that. And if late '22 is even in the cards for when we can expect commercial on-body injector. And then on TIGIT, just given the Argus release tonight, where they mentioned that the triplet with their PD-1 TIGIT in the adenosine looks like it's numerically outperforming doublet. Just curious how you're thinking about what you would need here to opt in on the Junshi TIGIT, if you'd be looking at doublet versus doublet or doublet versus a triplet in the market. Just curious how you're thinking about what you need for the opt-in.

Thanks very much for the question, Salim. Let me take the OBI question first. With respect to potential launch timing, we have not yet disclosed that. We had a few conversations last year, I remember you had some very salient questions at the time, the time of our PK study, which I think you turned out to be a little pretty close actually. It was very, very timely. But we won't have very much else to say about OBI until we have another disclosure to make, and so we'll just graciously decline to give some additional color with potential timing on that. With respect to the bi-modal model for OBI and how we expect OBI to do in the market, I'll just put that one over to Paul for a comment. Paul?

Thanks, Denny. Thanks for your question, Salim. Yes, I mean, Neulasta Onpro is proving to be resilient over the last 2 years with COVID, so holding on to 50% market share represents a very sizable opportunity for our on-body device if approved. And so we do see that as a growth catalyst there and aligns with our overall strategy of maximizing the long-term revenues for UDENYCA.

Now with respect to the doublet versus triplet that was TIGIT and so on, I think we've talked about this a little before, Salim. We view toripalimab really as the foundation stone and the backbone for our immuno-oncology franchise. And so we contemplate combining toripalimab with a number of agents, including TIGIT. So we expect, of course, to evaluate doublet strategies with toripalimab. We also contemplate evaluating triplet strategies with toripalimab. We see combinations as the wave of the future. And I think we've talked previously about our efforts at co-formulation, which is now well underway. That is toripalimab with various agents, including, of course, the TIGIT. We'll have a little more color for you on that and perhaps some data at the Analyst Day meeting in January. But yes, that, we believe, is the future of immuno-oncology, sort of doublet and triplet combinations, and we're gearing up to evaluate those.

Congrats on the progress.

Thanks.

Your next question comes from the line of Ken Cacciatore of Cowen and Company.

Just a couple of questions. Denny, the strategy you're taking in the PD-1 market seemingly being validated by others who want to take a similar approach. So can you talk about the likely evolution of the marketplace in terms of pricing and who can play in what area and why? And then on Lucentis, just wondering, this seems to be more of a managed care-driven approach. At least I would gather that would be the case, different than UDENYCA that had heavy commercial spending. So can you talk about the Lucentis opportunity in terms of the spend necessary to achieve what you want to accomplish? And then whether a biosimilar Lucentis may be a step through to the -- to EYLEA and others, and so maybe the evolution there. And then lastly, just wondering if you all would take a shot about timing of profitability again. It seems like we have a lot of good things happening, but wondering if you think 2023, we can break out and kind of forever put profitability kind of to what we experience as we go forward.

All right. I'll try to unpack that. You got 3 questions there. First, with respect to LUCENTIS, I think that the expenditures are relatively modest in the grand scheme of things. We've talked before about how we intend to leverage our existing infrastructure both in terms of the marketing side and so forth, and we've also talked about the size of potential sales force and boots on the ground being 25 folks, something around that order. I'll let Paul answer the follow-on question with respect to Lucentis with respect to how we see the market shaping up, our participation during market formation and the potential step through. Paul?

Sure. Thanks for your question, Ken. So unlike oncology, this retina market is highly concentrated. And so you've got a fairly small market that drives the largest percent of utilization. The other dynamic that's different is that it's much more Medicare driven because of the age of the population of these patients in general. And so the impact of commercial access isn't as great as it is in oncology and certain tumor types. So we believe we can be very efficient through proper targeting at the specialist level, the high Lucentis users and ensuring that really the pricing and contracting meets the customers' needs because those are big drivers. And so the good thing is not having that large commercial requirement on the payer side, really reduces the need to stack the rebates on the payer and the provider side. So we think we're going to be able to leverage the majority of our commercial infrastructure. We'll have a very focused retina team, and we'll be able to approach this market in a very efficient and synergistic way. And we believe, Ken, with a high degree of confidence, we're going to compete very successfully given our track record here.

And Ken, can you remind me a little bit about what you would like to know about pricing in the PD-1 market? Any detail where you're just looking for general color about what we think the pricing is going to do and thought.

Yes. Denny, there's a lot of folks actually. It's good to see, I guess, in 1 sense, bad to see when there's competitors, but folks are looking to take a similar strategy. So just there seems to be an evolution here, folks pursuing a similar game plan as yourself, just how you see this market playing out and yes, pricing and kind of who takes kind of what area and why. And just give us a sense of kind of as it gets a little bit more crowded, however one can participate.

Well, first, I would say that I think it's a bit premature for us to comment on pricing on particular segments. I would rather have either approvals or at least confirmatory data and indications or filing particular indications before we start talking about how we're going to go into particular segments, whether that's non-small cell or esophageal or with others. I think though that two broad -- as two broad sort of things emerge, though, from the market, in the very long run, I think that the PD-1s definitely will moderate in terms of pricing in the market; and then secondarily, will be replaced by doublets that are coformulated or combination strategies, which will relieve a little of the pressure on the therapeutic stack and the pricing of the therapeutic stack, which is probably not sustainable in the longer term. But if you let us get a couple of rules and a few other submissions under our belt, we'll be happy to talk a little bit more about our strategies and how we intend to get into each of these markets. Now let me take your last question, and I'll let McDavid chime in on this one. I think it was about the profitability in 2023 and how we see that evolving and so on. So McDavid, do you want to take that one?

Yes. Yes. Thanks for the question, Ken. So we recognize for a long time that 2022 would be a transition year between UDENYCA sales exclusively and the fully diversified portfolio, which will be up and running, we believe, in 2023. So we're managing Coherus efficiently toward the near-term launch of 4 new brands as well as the on-body injector for UDENYCA. And I'll remind you that our commercial organization is already operating at scale, and so new launches don't require de novo construction of commercial operations. And we believe that additional revenue will drop quickly to the bottom line. So in 2023, the fully diversified portfolio should be online, and we'll have 4 biosimilars, including UDENYCA with multiple different presentations, the OBI giving it the second lens as well as toripalimab approved with, we believe, multiple different indications that year. So it's 2023 is setting up to be a very exciting year and 2022 is a year where the story will be coming together rapidly.

I would further characterize 2023, Ken, as having a press modest increases in expenses. As McDavid indicated, there's a lot of leverage that we're going to exploit going into oncology between UDENYCA, Avastin biosimilar and the PD-1 but potentially substantial increases in revenues as we've all launched. So I think '23 is the year that will shape up quite well.

Your next question comes from the line of Chris Schott of JPMorgan. .

Just two on UDENYCA. Maybe, first, just elaborate a bit on sequential trends as we think out to 4Q. It sounds like you're expecting modest volume growth for the market next quarter. But can you just talk a little bit more about the competitive landscape and sequential price expectations? Is there more kind of mix shifts away from 340B, et cetera? I'm just trying to get my hands around can we think about you done kind of at a floor this quarter. Or is that a business that could continue to sequentially erode from here? And then my second question was just on the on-body product as we think about that launch over time. Is there an ability to differentiate pricing for that product versus the existing format given the different competitive landscape between the 2 products? Or is this really more of a volume play going after that 50% of the market that still is sitting with Onpro?

Thanks a lot, Chris. With respect to the sequential insights quarter-to-quarter, I'll put that one over Paul Reider, [indiscernible] has any comment on that, Paul.

Yes. Thank you. Yes. So obviously, our strategy is to maximize long-term UDENYCA revenues, and we're going to continue to balance the trade-off between price and share by customer, a competitor as the competitive intensity heats up and likely new competitors coming in, in 2022. So we're going to take a very careful review of that over time. Again, we're going to be focusing on Neulasta, which is the largest source of revenue and opportunity for us moving forward. And we're going to be looking at really those higher margin, higher value segments, which is the clinic and the non-340B segments, which as we demonstrated in the third quarter, we grew that clinic business and held firm under intense pricing competition in non-340Bs. So that's going to continue to be our focus. I think it's reasonable to assume with competitive pricing pressures some continued price declines into 2022 with some moderation of that in the mid- and long term.

Let me take the question with respect to OBI that you had, Chris, if I can give you some help there. The first thing I would say is that, after our announcement, the successful PK study, which, by the way, I think, is the really pivotal part of the development program that is the most difficult to pull off, actually conceiving a device, manufacture it, test it and having to demonstrate similarity with respect to pharmacokinetics, I think, is the tough thing. After that, you're in the business of filing and prosecuting the filing to get approval. But since we made that announcement, it's become very clear to us that there's really significant pent-up demand in the market for a on-body system in the hands of a biosimilar companies such as UDENYCA. So I think we're pretty optimistic about that and how it's going to move. Just how we're going to price that and what our strategy is for penetrating the market, how we're going to develop a holistic value proposition such as we did when we first came out with the prefilled syringe, I'm going to leave that for a little later down the road when we actually have that device approved and in hand. We'll be happy to talk about it then as talked about it now. But I would note the very significant pent-up demand for [indiscernible] device. Hope that's helpful.

Your next question comes from the line of Douglas Tsao of H.C. Wainwright. .

Questions, just one, Denny, in terms of the UDENYCA business. I'm just curious, once you eventually get your on-body device to the market, do you anticipate will that largely be going to the current UDENYCA book of business? Or from an account basis, will this represent an opportunity to really sort of penetrate accounts where you haven't had as much penetration to date?

Doug, great question. I'll put that 1 to Paul. Paul, what about the segments in the accounts for the onbody?

Yes. Thanks for your question, Doug. Now we see that the approval and launch of our on-body device enables us to go after that 50% of Neulasta OBI. So that's really the strategy we're going to take upon approval, and that's where the opportunity is. So we see it really being a play to capture more share of the on-body market.

I guess, Paul, what I'm trying to understand, though, where the on-body market exists. I mean are there sort of clinics or hospitals, et cetera, where you just simply haven't been able to get much traction just simply because they're predominantly using the OBI? And does that represent sort of an incremental opportunity for you to begin to compete just because they expressed the preference for that delivery system? And then I have a follow-up.

Yes, absolutely. Yes, Doug, I mean, the use of on-body is high in all segments, hospitals and clinics. And so as we are enhancing our segmentation capabilities, our intention is to be able to go very quickly into those particular segments, both in the hospital and the clinics and be able to demonstrate a different value proposition with the UDENYCA OBI versus the originator. So we believe that, that opportunity exists in all segments.

I would just -- I would further add, Doug, that there's -- to the question of accounts, definitely, those accounts that will be unlocked by our own onbody that have no alternative currently just with the innovator there with their device. And this is the reason I mentioned that I thought there was a significant pent-up demand.

Great. That's very helpful, Denny. And just in terms of the Lucentis biosimilar, is your focus going to be going after some accounts that might be predominantly users of EYLEA? Or are you going to be focusing across the entire market? Or we'd be focusing primarily on sort of high-volume Lucentis users?

Paul, do you want to take that one?

Sure, Doug. I mean, we see the whole VEGF market as an opportunity. Obviously, the short term is being able to rapidly capture share from the innovator, Lucentis. That's the low-hanging fruit. But we believe based on what we are understanding about this marketplace, where pricing and contracting and value is extremely important that we'll be able to deliver a value proposition that will be able to enable us to compete within the entire VEGF market.

Your next question comes from the line of Jason Gerberry of Bank of America.

Just wanted to get your perspectives on this Eli Lilly AdCom and your ultimate views. It sounds like there's a growing consensus view that maybe the FDA's tone is changing here with respect to accepting China only Phase III studies. And so just sort of curious how you think about that nuance with the different potential filings with toripalimab. And ultimately, do you think there's anything materially different about your program versus some of the other PD-1s that have been studied and developed primarily in Chinese subjects? And then just a quick one on the Neulasta on-body program. Just if you can talk a little bit about any thoughts on how this plays out in terms of rollout and whether or not you anticipate any sort of IP or patent-related challenge?

So let me take the first one first on this one. So with respect to other teams' programs, Lilly's programs or others, we haven't taken a deep dive into their clinicals or reviewed their data or, of course, not reviewed their FDA correspondence. So we're not in a very good position to comment, except I can say that our understanding is that Lilly with sintemab most likely will have an AdCom to review data. I can also tell you though that with our own communications with FDA and toripalimab with nasalpharyngeal, we will not have an AdCom. We've had communications with FDA saying an AdCom will not be required for our indication. Now I think that the overarching color here is that a number of products have shown up, and the FDA probably is going to take the opportunity to make thorough reviews of the data. But overall, I think we're pretty familiar with the types of conditions that the FDA looks at and what they've imposed. They must have, for example, similar standards of care with respect to the co-therapies. You have to catch the patients at the same progression of disease. There can't be any significantly genetically driven histological differences. And that -- so therefore, the results are highly generalizable. And then lastly, which I think is very important, the studies have to be conducted in a very rigorous fashion, with CGMPs consistent with FDA standards. And we think that the Junshi-Coherus pivotal studies conform to all those conditions. And our strategy here, of course, is just with MPC once we get the data, we'll go forward to the FDA. We'll review with it, and we'll discuss the registration strategy. And so once we have those conversations, we'll come back and check.

Got it. And then, I guess, just the on-body one is the other follow-up.

Yes. Were you wondering about exactly what part on-body?

Just do you anticipate timing market access? Are you anticipating any sort of legal patent barrier at all to market access?

Sure. Yes. So I would say that the -- we have certainly thoroughly considered all relevant IP that's out there with respect to on body and so forth and how to do this. We totally respect on body -- respect intellectual property, whether it's ours or whether it's other folks. And given all that, we expect to launch our on-body program accordingly. So I think that we've been very, very thoughtful about the intellectual property. I won't dive into the specifics of it. But there is IP out there, and I think it has to be observed.

[Operator Instructions]. Your next question comes from the line of Balaji Prasad of Barclays. .

Just one from me. Denny, you have in the past spoken of a $400 million to $500 million opportunity for biosimilar Humira assuming a 10% share in a $4 billion to $5 billion market. Now with your competitors working on interchangeability or a couple of them already have, do you think that there is a reason for us to revisit those assumptions in light of these developments? And b, would you want to work on interchangeability yourselves? Or are you? Lastly, maybe just extrapolating this to the profitability in 2023, how much would Humira contribute in your internal plans?

Thanks not for the question. With respect to the impact of interchangeability on the HUMIRA biosimilar market, I'll let Paul take a shot at that. Paul.

Yes. Thanks for your question. So interchangeability is subject to state pharmacy laws, and so far, it's not been a requirement to support any biosimilar adoption, which has been quite significant over the past several years. We believe that payers will be the primary determiners of product selection and that they have the formulary utilization controls to enforce their formulary choices, their regular practice and multiple product categories today. And given the payer stance on the utilization of these formulary practices to drive this switch, we don't view interchangeability as an essential feature for commercial success. Given that, Denny, you want to...

We think there's sufficient payer power in the market to impose their formularies. And so we don't see that as a substantial impediment and so forth. With respect to actual contributions in '23, '24, '25, I think we'll leave that 1 for another day as opposed to stream from that.

There are no further audio questions at this time. I will now turn the call over to Denny Lanfear.

Thank you. I just want to take the opportunity just for a brief recap. I think we've made some excellent progress with our programs in the past quarter. We're bearing great through with all the things we've done with the Lucentis biosimilar, the Humira biosimilar, the toripalimab application and so on. I think you can look forward to additional progress from the company. We're, of course, very excited about our progress with our on-body system, which, as you know, we all worked on for quite a bit. So we look forward to catching up with you guys all at the analyst meeting, which we think is going to be sometime in mid-to-late January at this point. So thanks for joining us today.

This concludes today's conference call. Thank you for participating. You now disconnect.