Coherus Oncology, Inc. (CHRS) Earnings Call Transcript & Summary
January 10, 2022
Earnings Call Speaker Segments
Christopher Schott
analystGood morning, everybody. I'm Chris Schott at JPMorgan, and it's my pleasure to be introducing Coherus this morning at the 40th Annual JPMorgan conference. For the company, we have Denny Lanfear, the President and CEO. And before I turn it over to Denny, I do want to remind everybody that if you want to ask a question, feel free to use the Ask a Question feature on the website, I'll work those into the Q&A post the presentation. With that, Denny, happy new year. Thanks for joining us and look forward to the presentation.
Dennis Lanfear
executiveChris, and thank you once again for your kind invitation to this year's JPMorgan conference. Sorry that we couldn't be with you in person. Let me first apprise you, of course, of the forward-looking statements and direct the audience to the requisite SEC filings with respect to each of the company's products including UDENYCA, YUSIMRY et al. Let me further comment that the slides you will see today are on the Investor Relations portion of the Coherus website. So today, I'm going to talk to you a little bit about Coherus and our positioning in the market of long-term growth and sustaining shareholder value creation. We believe the company presents a very unique value proposition with immuno-oncology portfolio funded by biosimilar revenues. Our PD-1 toripalimab, we believe, is very unique, I'm going to discuss the mechanism of action and some complementary products a little later today. And we believe that the long-term growth of the company based on the biosimilar portfolio and the toripalimab label extension will carry us through the latter half of this decade. So as you know, over the last 2 years, the company has been building a leading immuno-oncology company funded with product revenues from our very successful biosimilars business. This IO growth leverages our existing commercial operations and R&D capabilities, I'll talk to you about some of the additions we have made to our team over the last 2 years as we have moved towards immuno-oncology. Our PD-1 toripalimab, has demonstrated significant clinical efficacy in multiple tumor types, well positioned as a foundation for next-generation IO combination therapies and with a potentially differentiated mechanism of action based on unique binding epitopes. Through the last half of this decade, we believe you will see launch as many of 5 new products, building on the success of UDENYCA. As you know, we recently had YUSIMRY, our Humira biosimilar approved. We will continue to expand the toripalimab label, and we will then move towards novel I-O combinations and therapies. The first one, of course, will be the TIGIT. The company has very -- done very, very well in 2021 with respect to its key objectives. First of all, on the left side, with respect to our biosimilar portfolio, YUSIMRY, our 1420 molecule or Humira was approved just last month. We also, notably, successfully completed our on-body injector PK clinical trial, setting us up for a filing of that this year. UDENYCA has maintained its position as the #1 pegfilgrastim pre-filled syringe and the CIMERLI as the Lucentis biosimilar BLA was accepted. On the immuno-oncology side, we continue to build out immuno-oncology portfolio, and we successfully in-licensed an excellent PD-1 inhibitor toripalimab from our good friends at Junshi. Toripalimab has been developing a series of very positive clinical dataout -- readouts, which you seen at ASCO, the World Lung Conference, et cetera, and was featured on the cover of Nature of Medicine. And further, the toripalimab BLA has got a priority review for NPC. Lastly, as you know, this morning, we announced that we have initiated our TIGIT option exercise for co-development with toripalimab. Our long-term strategy in immuno-oncology is threefold. First of all, our PD-1 toripalimab comprises the backbone of our efforts, and we intend to expand out label in lung, and other indications after getting approval in nasopharyngeal and further to establish partnerships with third parties to drive toripalimab utilization. Another key part of our strategy here is the fast-follower portion. Moieties exemplify it by, for example, the anti-TIGIT and the engineered eIL-2, both of these subject to our agreement with our colleagues at Junshi. Here, we will evaluate and partner these assets and, particularly with respect to the TIGIT, we've made very good progress on co-formulation efforts. We are also pursuing transformational assets. These are opportunities to make a step change in cancer care, addressing the tumor microenvironment, various aspects in the cancer immunity cycle. We have begun work on an internal pipeline of products which we expect to file the first IND next year in 2023. Over the last 2 years, as we've moved from biosimilars to immuno-oncology, we've also built the infrastructure of the company and we have put in place the requisite expertise necessary to be accessible in immuno-oncology. On the right side of this slide, you see our scientific advisory board led by our Chair, Ildiko Csiki, who is the Chief Commercial Researcher and Development Officer at City of Hope. Dr. Csiki also is previously with Merck developing KEYTRUDA. Samir Khleif is a well-known investigator. Thomas Graeber, from UCLA. Carl Ware, Stanford-Burnham Medical Institute. I want to thank the SAB for their advice over the last 2 years as we selected our PD-1, reviewed all of our options, and now as we move forward into combination therapy. On the left side, we've made very good progress building out our internal capabilities. We've been joined by Dr. Theresa LaVallee, who is our Chief Development Officer. Dr. LaVallee is most recently from the Parker Institute, formerly of AstraZeneca. Also, I want to acknowledge Sanjay Khare, our Senior Vice President and Head of Immuno-oncology. Sanjay's previous positions included those at Mayo Clinic and Amgen, and Sanjay and his team were instrumental in selecting our PD-1 toripalimab, and Sanjay is now leading bioinformatics unit to develop some additional novel moieties. Now, let me talk a little bit about the commercial biosimilar portfolio and the updates there. As you know, we're in 3 key areas: oncology, ophthalmology and immunology over the past year. As I recapitulated earlier, we've made good progress in all 3 areas. First of all, with UDENYCA, we're very happy about our on-body injector progress. This will position us well to file the approval of supplement this year in 2022. UDENYCA, we remind you, is the pegfilgrastim pre-filled syringe leader. We've delivered over $1 billion in net sales since launch in 2019, which was quite successful. Further, Neulasta Onpro still retains greater than 50% of share, and we believe that our on-body system will give us the opportunity to mine against that market share going forward in the future. Last year, in 2021, we saw a successful filing of the CIMERLI, that's our Lucentis biosimilar BLA in August. We believe this product should get approved at the 1-year mark in August of 2022. Launch preparations for the Lucentis product are on track. And as you see, this product addresses a $5 billion to $6 billion market. The company also was successful in getting YUSIMRY, the -- our biosimilar to Humira product approved. This is a very large market, and we're very well equipped to address this. And just make a few quick points here. We have made certain that we have significant supply available to address the market needs, very high-quality manufacturing and also an excellent auto-injector and pre-filled syringe, both with citric-free, sting-free formulations to meet patient needs. We'll approach this market with patient support systems similar to we've done with the UDENYCA market, and we believe that we'll be very, very competitive with respect to pricing and so forth. That launch, of course, is planned for July 2023. These biosimilars, as we bring them forward over the next couple of years, will take our addressable market from about $3 billion now for UDENYCA, an additional $16 billion and $6 billion for YUSIMRY. And similarly, respectively, and then additional market access with our Avastin biosimilar. This brings our total market opportunity for the biosimilar portfolio to about $28 billion. And I'll just remind you that the company's objectives are that we will take 10% market share for each of the markets that we enter. Let me talk a little bit about now toripalimab, our PD-1, and why we believe it's very special and how it's positioned for our next-generation therapies. So Toripalimab has shown robust efficacy across a number of tumor types, and our strategy here is very unique. And we have a BLA under prior review for nasopharyngeal with the FDA with breakthrough status. There's significant opportunities to expand the label, and lastly, we now have opted -- are in the process of opting in on JS006, which is a clinical stage TIGIT from our colleagues at Junshi, and I will talk about that just secondarily. Now, toripalimab was designed as a second generation of PD-1 addressing a unique epitope approach that is the FG loop with the PD-1 molecule, with the receptor. And what toripalimab does is it induces PD-1 internalization, secondary to the binding, that then initiates a series of signaling within the T cell. And here, you can see it's a very high affinity PD-1. You can see toripalimab's [ efficacy ] is very, very high, favorably compared to both Pembro and Nivo. Now, beyond blocking PD-1 receptor internalization is a second mechanism that potentiates immune suppression relief. As I indicated just a moment ago, what this does is reduce TCR signaling cytokine production. And we have seen developing data, which gives us reason to be hopeful that toripalimab may have a differentiated clinical profile, which will wait through the rest of 2022 to demonstrate to you. But a decrease in PD-1 expression can improve the activity of T cells to the engine. And as we go forward and turn over the rest of the data cards, I think you'll see some of that coming forward. Now, toripalimab has been recognized as unsurpassed molecule. Of course, nasopharyngeal is a unique small indication. Toripalimab was featured on the cover of Nature Medicine Magazine. As I indicated earlier, there's a unique registration strategy for toripalimab. First, addressing an unmet need in a rare cancer, which is very, very important from the viewpoint of the patients. Gets priority review from the FDA, we expect to be in the first line as well as second and third line and with NPC. And of course, as I indicated, FDA granted breakthrough therapy earlier for both first line and second line/three line NPC. We have an April 2022 PDUFA date with FDA. I don't have an update for you today, but I would say we do not see any reason why the approval would not proceed as planned. Toripalimab continues with compelling clinical data from pivotal studies in multiple tumor types. It was featured in the plenary session, of course, at ASCO, and with the JUPITER-02 data. The CHOICE-01 data in non-small cell lung cancer has shown excellent results, progression free survival. That was shown at the World Conference on Lung Cancer in September. And then lastly, esophageal squamous cell carcinoma overall survival data at ESMO. We believe that all of these indicate that we have an excellent PD-1 ideal for peering with other moieties in immuno-oncology. Toripalimab will compete in a rapidly growing PD-1 market. This is some $30 billion market by 2026 across a number of other indications, as you know. By 2025, we believe toripalimab could be approved in multiple indications, impacting nearly 0.5 million patients per year, providing accelerated growth potential for the company in the second half of the decade. Now, let me talk to you a little bit about today's news. The company is in the process of exercising its option on JS006. This, of course, is the TIGIT license from our good friends at Junshi. This marks the emergence of Coherus as an immuno-oncology development company. Now, the cancer immunity cycle provides a number of opportunities for therapeutic intervention, with toripalimab as the base of combination therapy. Of course, there's a number of teams looking at LAG-3, TIGIT, VISTA, et cetera. And we will start, of course, with TIGIT as we've talked today, but we are also proceeding on a few other fronts with the tumor microenvironment here. We'll talk about subsequently, particularly at our Investor Day a little later on. Now, the dual immunotherapy of TIGIT plus the PD-1 has potential to become a new standard of care as you know across a number of tumor types. TIGIT and PD-1 appeared to operate synergistically, they are co-expressed on memory cells, and there's a certain amount of cross talk between the 2 of them. And we believe this is the reason for the evolving clinical story with TIGIT with a few teams. JS006 is a very high affinity and potent anti-TIGIT and here you see cell-binding assays and cell-based receptor assays. JS006 was designed to be as potent as other leading TIGIT in the field, augments T cell signaling and demonstrates a similar activity to TIGIT benchmarks, toripalimab. JS006 has significant antitumor activity in combination with PD-1 and here you see mouse data in the CT-26 model showing such. It demonstrates dose-dependent antitumor activity and enhanced antitumor activity with toripalimab. On the clinical side, TIGIT is currently completing the pharmacokinetic studies, both as monotherapy and in combination with toripalimab. We will then expand those cohorts and move towards registrational combination studies in global programs, both in the U.S. and outside the U.S. going forward in selected indications. And we'll be talking a little bit more about the specific registration strategies at our Investor Day. Our antibody development capabilities come forward from the expertise built to the biosimilar business. Our analytics, protein science, immunology and biopharmatics. Here's a picture on the right panel of our labs in Camarillo, California. It's a 25,000 square foot facility, and we have a significant number of our team members there. But these team members are developing antibodies addressing various aspects of the cancer immunity cycle and the tumor microenvironment, and we project to have our first IND in 2023. The other comment that I would make here is that there is relatively low incremental in the mid- to low millions of dollars to bring these products forward to IND, and then we'll be in a very good position to understand their therapeutic utility. Let me now talk about the long-term growth story, and just recap a for you, a few things about the pipeline. The total addressable market for Coherus now with I-O triples, with PD-1 and the I-O combinations. You see the $28 billion that we were able to approach with the biosimilars portfolio in the near term with YUSIMRY and CIMERLI, et cetera. And now with PD-1 therapies, an additional $23 billion and various long-term combinations. This drives us to a total market opportunity of $70 million to $90 million as we approach the second half of the decade. And lastly, let me just recap for you some of the progress that the company has made to date and to look forward for 2022. With respect to FDA target action dates, toripalimab BLA action date is in April of 2022, similarly in August of 2022. That will give us 3 products approved within a 12-month period, including YUSIMRY, which was just approved in December. New product launches. Toripalimab this year, of course, that is going very, very well and CIMERLI in the second half, post-approval. Potential BLA and supplemental filings, the UDENYCA on-body injector continue to grow into the [ brochure ] of the Neulasta business. And of course, the toripalimab BLA supplements. On the immuno-oncology clinical data side, there'll be a number of readouts coming first-line small cell, neoadjuvant, non-small cell, first-line TNBC, et cetera. So you can see steady news flow this year and turn over a number of data cards and move forward with the immuno-oncology portfolio. And then lastly, we've also made good progress on the corporate and strategic front. We recently refinanced our debt, secured additional credit financing, initiated the TIGIT exercise. And we project having an analyst and investor event now for March of 2022, at which time we'll be able to update you on our clinical plans and our progress with biosimilar portfolio. And with that, Chris, I would just stop here, and I'll be happy to take your questions.
Christopher Schott
analystGreat. Maybe just to kick off on my end with toripalimab and the label expansion in particular. I think there has been some questions around the FDA accepting China-only kind of Phase III studies, and there's a panel coming up on this topic. Just -- what's your latest thoughts here? I understand the initial indication is probably less of a concern. But just if we think about gating into long and some of the bigger PD-1 ends, just -- how are you thinking about that from a company perspective?
Dennis Lanfear
executiveWell, first of all, I would just underline once again that I think we have a unique registration strategy with the pursuit of orphan unmet indication to get the product approved and on the market. As you know, there is expected to be an advisory committee meeting in February, I don't want to front run the FDA on that particular meeting at this time what goes forward. But I think we've had a number of fruitful conversations with the FDA with respect to the portfolio. We'll have to see how the outcome comes out. We'll be in a position to update you, I think, at the Investor Day conference and when that comes down in March. But I would say that toripalimab has performed very, very well across a number of large indications.
Christopher Schott
analystOkay. And I guess the one question I do get, if there was some incremental work that had to be done to get into some of these indications. Is that something the company would be interested in pursuing? And is that something that Coherus would be responsible for? Or that's something your partner would be driving?
Dennis Lanfear
executiveIf there are additional -- that's a fine question. If there are -- is there additional work has begun in the U.S. to backfill any of the clinical packages, we certainly would be happy to do that. In subsequent conversations with the FDA, that's something that we would drive. And we would expect to take over the sponsorship of the toripalimab BLA and regulatory files post-approval, and so that's something that will land in our wheelhouse.
Christopher Schott
analystOkay. Okay. Makes sense. And I know in the PD-1 space, there's some companies have been thinking about EQRx and Lilly, maybe specifically talking about steep price discounts as a strategy. I know you're not necessarily getting to specifics of your exact pricing strategy, but just conceptually, what do you think about that approach of -- I think there -- somebody is coming and talking about 60%, 70% kind of list price reductions as -- [ reduction ] of how you see those players kind of positioning themselves in the market?
Dennis Lanfear
executiveWell, I think that conversations over pricing and positioning are best left to post-approval. Our focus really is getting on NPC approval and then subsequent indication approvals. I believe that toripalimab is a second-generation PD-1 with a potentially differentiated mechanism of action. We expect to see continued data readouts along those lines this year. But to be direct, I think it's premature to discuss pricing unless there's an approval in hand.
Christopher Schott
analystOkay. And then on the TIGIT, obviously, very exciting mechanism. Maybe just talk a little bit about how you're seeing the competitive landscape shape up with TIGIT? And just how do we think about timelines for development from here?
Dennis Lanfear
executiveThat's a great question. So our strategy with the TIGIT, and indeed, the middle part of our portfolio that I showed you earlier, we consider those our fast-followers. With those, what we do is we're probably going to position ourselves a year or 2 back from the market leaders. And while that does result in a bit of a delay, on the other hand, we don't have to pursue all the indications, all the spends, all the large studies. So we expect to watch the market very, very carefully and then be a fast-follower and get on the market probably a year or 2 later. We think this is probably -- for these particular assets, this is a better opportunity. Now, there might be some assets in which we move to the very front. But just focusing on things like TIGIT or the engineered eIL-2, and we think that's the appropriate strategy.
Christopher Schott
analystOkay. And can you remind us, just for folks listening in, just on TIGIT, on the -- obtaining the financial responsibility for Coherus to develop that product?
Dennis Lanfear
executiveWith respect to TIGIT, the way the agreement is constructed is that there -- first of all, it's co-developed with JDC, there's a global program. Our participation financially in the global program is capped at $25 million per year. Per product, actually, for toripalimab and TIGIT and whatever else comes out of there. However, if there's anything that we wish to do in the United States for our own market, we are, of course, free to do that at our own expense. And then there's opt-in mechanisms, secondary to that fortune sheet for various cost sharing. But the basis of it is cost sharing up to $25 million per year for the profit, for global integrated studies that would serve various geographies. But we're also free to do this.
Christopher Schott
analystOkay. And it sounds like depending on what comes out of this FDA panel that might inform if you want to do some U.S.-specific work or not, so that might -- definitely a little more clarity as we -- maybe the Analyst Day of what that could look like? If it is fair to say.
Dennis Lanfear
executiveAbsolutely.
Christopher Schott
analystOkay. And then final question just on the I-O front. It sounds like the additional I-O targets, more of those networks can be done within Coherus versus working with a partner. Is that kind of the message we're hearing?
Dennis Lanfear
executiveThat is the message that you're hearing. Dr. Khare came out of Mayo Clinic and Amgen, a very, very brilliant guy. PHD in Immunology, and has a robust bioinformatics group that we've set up. And we're currently looking at a number of targets, we work very closely with our Scientific Advisory Board on that. We've got, I think, 4 to 6 targets under development now. We'll start to initiate IND filings for those next year and you'll see a stream of those moving forward. We want to engage in huge spends for those products, and they won't hit Phase III until certainly into the '25, '26 time frame when we have robust revenues from the biosimilar portfolio and indeed from toripalimab to support the immuno-oncology.
Christopher Schott
analystOkay. That makes sense. Just pivoting to the biosimilar part of the portfolio. Maybe just a quick update on UDENYCA, just the competitive landscape we've been seeing here. Any notable changes that you've been seeing over the past few -- as we think about whether it's Omicron or just general price [ uptick, possibly ] if you can report on that front, I guess?
Dennis Lanfear
executiveWell, COVID is not our friend [indiscernible] UDENYCA or a number of things. But our team is doing -- I think our team is doing very well with UDENYCA, but we've been cognizant for a long time that, as a single product company, we need to expand. And we really -- over the past year, I think we've made substantial progress with YUSIMRY approval and the filing of the Lucentis biosimilar and the PD-1 deal and -- which will be approved next year. So certainly, with one product in the market, it could make life difficult when things like COVID represent a headwind for us. But I think that we're doing fine there, and we have a number of other products in line, so. But I wish, like all of us, we wish that COVID would wane and go away and fade a bit, but it is what it is.
Christopher Schott
analystAnd I know the story is broadening out quite a bit this year, but I see. And then just, I guess, on UDENYCA, on that same topic, though. When I think about the on-body opportunity, I guess, thinking it may be up to 2023, how do you envision the market kind of , I guess, changing from a Coherus standpoint. It was about half the market still on Onpro. Does that enable you to differentiate on price? Is it more about getting volume? I'm just trying to understand a little bit how much that reinvigorates that kind of initial franchise that you've had on the market?
Dennis Lanfear
executiveWell, I think that it's significant. I believe that COVID is going to be with us for a while and in various ways. There are changes in practices with oncologists that have occurred. I think that there's value for segments of patients not to come back, obviously. I think that we will probably be unique next year and having an on-body -- a biosimilar with an on-body system to compete against the Amgen. It has represented a reservoir of share that's been difficult to [indiscernible] without that. So I think that there is a significant amount of share we had. We did very well in year 1 with the PFS business. We captured about half the PFS business in the first year. I don't know if we'll do quite that with the on-body -- the first year that we come out. But certainly, having both presentations, pre-filled syringe and the on-body I think, gives us a lot more leverage in the market.
Christopher Schott
analystYes. And to the extent in terms of the other biosimilar players, I mean, how much visibility do you have in terms of how much of a lead you have in this market and how many of these players may be able to get to an on-body device over time?
Dennis Lanfear
executiveI think that overall development of additional presentations for the pegfilgrastim market, in particular, is difficult. As you know, there's very high inter-patient variability. And even teams that did simple injectors and pre-filled syringes when they did their PK studies sometimes fail quite a bit. I know that we did, I think 2 or 3 PK studies before we were able to get an understanding of just how the patients performed and how to control the variability. For this reason, I think that the on-body pharmacokinetic data that we brought forward last year in October is very, very important. I think it's a difficult undertaking to get a on-body pump to demonstrate bioequivalence. And so I think that the bar is a bit high. There's also, I think, certain technical hurdles, which have to be addressed with an on-body system. We worked on a device, as you know, Chris, I think, 3 years based on that. I think a couple of different partners and so on. So I think it's probably a little difficult to bring forward, so I'm not sure how many teams will be able to do that. We had to focus -- we had to focus on it.
Christopher Schott
analystYes, it seems like a pretty interesting opportunity. Then pivoting over to Lucentis. I guess, maybe first of all, just -- you've got the -- August PDUFA just latest thinking in terms of timing relative to Biogen. Are you, I guess, generally, are you still expecting to be able to launch pretty close to market formation for this one?
Dennis Lanfear
executiveSo I believe that I think that the other teams are around in June, and we don't have any reason to believe will be delayed for our approval past August. We'll see how the first part of this year goes from interactions with our partner, Bioeq, with FDA. But yes, I think that's around the market formation for that product. I won't say too much about our market penetration strategy at this point for competitive reasons. But I think certainly, we're at the front.
Christopher Schott
analystOkay. And maybe just bigger picture though, I think on the commercial strategy for a product like Lucentis, maybe just compare and contrast versus how Neulasta formed. To help out -- in terms of like how quickly it evolved, how [indiscernible] aftermarket? Is there anything you can just kind of -- analogies you can draw from that first big launch that you had?
Dennis Lanfear
executiveWell, as you know, the ophthalmology market is a Medicare Part B market, it's constructed very similarly to the oncology market. There is a number of constituent entities that have to be addressed and aligned in order to be successful, whether they are GPOs or wholesalers or payers or whatnot. So I think that's -- it's some amount of -- it isn't being in a complex environment and things are done. That being said, I think that Coherus demonstrated its mastery of that in 2019 and 2020, and our ability to get into the market very rapidly. We never really resorted to draconian price cuts to do so. And for the longest time, we had the highest ASP, for example, and really only reacted to price-cutting initiated by others. So I think that our strength is our understanding of the Medicare Part B market and our ability to get all the constituent parties will align. I think that skill set transfers very well to ophthalmology. And you have probably even a higher concentration of practices and physicians and so on, so there's lots of a footprint that will be required there to go forward. We have about almost 60 to 70 folks on the oncology side, and we'll have far less than that with the ophthalmology side with that particular product. But we think we'll be very successful there. It's another market in which people are waiting for a biosimilar for a variety of reasons, patient benefit and market penetration, for example. So we think we'll do just fine there.
Christopher Schott
analystGreat. And then just -- I think you talked about kind of this broader VEGF market beyond Lucentis. I think -- should I think about the initial opportunity mostly being Lucentis? Or do you think you can almost immediately start cannibalizing a bigger portion of the space here?
Dennis Lanfear
executiveThat's really a question of how much, how soon. And we think that the entire market is addressable, the whole $6 billion. I think it really depends. Certainly, clinically, there's data which says that of the 2 major treatment types, one is the same as the other and so on, so we don't really see a lot of differentiation there. But our view is that we offer a choice in that market and then let the physicians decide, but we intend to offer that choice to everyone.
Christopher Schott
analystOkay. And then just the last few minutes here, just to -- just Humira. I guess my questions for you guys is if there's interchangeable biosimilars from Humira that have now been approved, how important do you think having interchangeability will be in terms of the market formation here?
Dennis Lanfear
executiveThat's a great question. We have never thought that interchangeability is such a substantial impediment to market adoption as to justify the investment for the studies. The studies are large and complex and expensive and so on. The first team comes out of the interchangeability will have that, I think, for about 12 months. We'll launch within that window and come out without interchangeability consistent with our current plan. But just how that market behaves a year, 1.5 years or 2 years in, particularly with some of the large market participants who will not have interchangeability, we'll just have to see. We think that's very much a payer-driven market, and our focus for there has been to bring forward, first of all, a product which is a sting-free formulation, which is very, very important. Companies had strong formulation technology to do that. We've had a citrate-free formulation from the beginning. Also to have an excellent auto-injector, patient acceptability is a very big deal to be able to do that. Thirdly, large scale. We've made certain investments, as you know, in scale, so we could be the low-cost producer for that market in high volume as needed. So I think that we'll do very, very well there, but I don't think that interchangeability is a fundamental impediment to adoption that can't be overcome.
Christopher Schott
analystOkay. And then just in terms of the innovator and their approach to the space, what are you anticipating AbbVie does here? And I think they've talked about desire to keep a lot the in forward approach, and maybe keeping a lot of volume. Do you expect that they're going to be actively trying to contract and offer incremental rebate, et cetera? And I guess, how does that affect your view and how the market performs here?
Dennis Lanfear
executiveAbsolutely. I think AbbVie will find itself in full-on competition. But that's okay. We're basically the biosimilar street fighters. We do not shy away from competition. We've done very well in competition. We're a very, very competitive team. I think that we know how to work biosimilar markets, so we're not concerned about the competition. It might be more difficult for other teams, but yes, sure. AbbVie will compete, attempt to retain share, we expect that fully.
Christopher Schott
analystOkay. And I mean, if you think about Neulasta, as an example, I mean, is giving a sense of being a situation where like half the market stays with AbbVie today and half is available to biosimilars? Or is this one where maybe more of that volume comes over to the biosimilar side?
Dennis Lanfear
executiveThat's a great question, Chris. I think that ultimately, that market is going to, I would say, significantly convert. I think there's just going to be a lot of pricing pressure, a lot of folks showing up. I think that's going to be very difficult to maintain 50% more market share for an innovator in that kind of a high-pressure environment.
Christopher Schott
analystExcellent. I think we're just about out of time, Denny and McDavid. Thanks for joining us today. I look forward to the analyst meeting in March, and obviously, a pretty exciting year ahead for the company. So thanks again for joining us.
Dennis Lanfear
executiveThanks, Chris. Take care. Bye-bye.
Christopher Schott
analystHave a good day.
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