Good morning, everybody. I'm Chris Schott at JP Morgan. It's my pleasure to be introducing Coherus today. From the company, we have Denny Lanfear, President and CEO, who's gonna make some opening remarks, and then we'll jump into a Q&A session with the broader management team after that. With that, over to you, Denny.
Thank you. Thank you, Chris, and thank you all for joining us today. Let me first apprise you of our forward-looking statements and direct you to the company's SEC filings. I'll try to remember to call out the slide numbers for those of you on the webcast since it's not concurrently for broadcast. Today, I'm first gonna talk a little bit and summarize the company's strategy. Then I'm gonna talk about the ophthalmology franchise, which is evolving our oncology franchise. I'll make a few comments about YUSIMRY, and then I'll focus a bit on the company's IO franchise before I wrap up. Slide four. I'm very proud of the progress the company has made in the last 12 months. Since the last conference, we made strong strategic progress.
We have multiple product near-term launches, and we have made very good progress on our innovative IO pipeline. I think I talked to you last time, within 18 months, we were going to launch four products. We are doing that. Our CIMERLI product, which is partnered with my good friends at Pharmakon, has been launched in Q4. I will talk to you a little bit about that and how that's gone. We are preparing for the launch of toripalimab. As you know, there's a hold up there with inspections in China. Be happy to take questions during the Q&A period with Dr. LaVallee on how that is going for you. YUSIMRY is teed up for launching in July of this year into a $20 billion market.
I'll also update you on the company's on-body device. Lastly, I'll spend a little time with our new product, our EYLEA biosimilar, which we have just announced. The launches will provide us with a steady stream of revenue through the rest of this decade to support the IO franchise. That franchise is comprised not only of toripalimab, but also CHS-006, our TIGIT. Our TIGIT, as you know, is moving along well. ILT4 CHS-1000. Slide six, I'm happy to tell you about our EYLEA biosimilar. This will expand access across the rest of the ophthalmology landscape that we currently do not address. This was just announced. EYLEA, of course, a very important product.
We expect this product to launch into this market in about mid-2025. This product probably will address about 75% of the overall VEGF market, which is currently about $7.2 billion. Now, as you know, when we first licensed in the LUCENTIS biosimilar, similarly, our strategy was to enter in the midpoint of this market and then expand downward into the Avastin reformulation portion of it, and then later upward. That is moving along well, as you can see here on slide seven. Paul Reider, my Chief Commercial Officer, is able to take your questions, but Paul and his team are making very good progress on the CIMERLI launch, and so on, and we'll talk about that subsequently.
I think that adding an EYLEA biosimilar will significantly increase the company's footprint in ophthalmology, which we view as a very promising buy and build arena. One key thing about this market that I would direct you to in the very bottom of this slide, reformulated Avastin comprises about 40% of the units, not the dollars, but the scripts. With the Medicare coverage here in this particular therapeutic environment, there's significant opportunity to convert the reformulated Avastin to biosimilar LUCENTIS. On slide eight now, we'll talk a little bit about the synergies that we are realizing with this. When we went to launch CIMERLI, there was a considerable amount of enthusiasm from the providers for an EYLEA biosimilar.
To a fair degree, our in-licensing of this asset is a reflection of us listening to our customers. The other thing, of course, though, is that there are significant synergies. We don't have to put any more boots on the ground. We can use our existing team to go ahead and do this. It leverages further our buy and build market expertise that we developed in oncology with UDENYCA. Lastly, I would point out that this still leaves us with additional bandwidth that we can use in ophthalmology for adding additional products. On slide nine, I'll just summarize a little bit the CIMERLI situation. As you know, our team did a great job. We had not only the full label and both dosage forms, but we also obtained interchangeability with 12 months exclusivity.
This gives physicians confidence that they can switch patients to a biosimilar, LUCENTIS, which we have done to good effect. We have projected that we will achieve in excess of $100 million in revenue for this product in 2022. Here on slide 10, just an update on how the launch is going so far. We're only three months into it, but just a couple of key points. First of all, over 3,200 sales calls have been delivered since launch. 93 accounts have purchased CIMERLI. More importantly, we expect our Q code to be issued April 1st of this year. Things are a little slower because there has to be a miscellaneous code, which is a bit of a hassle for the providers to use.
We expect in Q2 and on, with the Q code, things to take off substantially. We are also making excellent progress on our insurance coverage with the payers. Over on the right panel of this slide, you see the results. As you know, with UDENYCA, we did $356 million the first year, $476 million the second year, achieving over 20% market share in the first year. We believe this is tracking along very successfully for this. Now, let me talk a little bit about the oncology franchise on slide 12, starting with an update on the UDENYCA OBI. As we promised you last year, we would file the BLA in 2022, which we did. We are confident that we will get approval in 2023.
This is will be a very important development because it addresses a key part of the market, which is in excess of 40%, that I'll talk about in the next slide. It allows us really to leverage our existing market access positions very straightforwardly, our sales force and so on. The point again that I would make here is there's considerable enthusiasm and pent-up demand in the environment for this device. That segment of the market comprises about 150,000 units per quarter or 600,000 per year. There is about 1.2 million units overall of pegfilgrastim per year. We believe that our device will be both differentiated and well-received.
We are the only team with a on-body device that has published their PK and their PD, having done so last year at ASCO. Slide 14 now, let me turn just to our toripalimab asset in our IO portfolio for you. I wanna make a few key points about IO, first of all. Our view when we initiated our strategic pivot two years ago, that it was absolutely essential to have a proprietary PD-1, and we looked, as you know, to over a dozen of these globally before striking a deal with my good friends at Junshi. In IO, I believe there's a bifurcation of teams that have their own proprietary PD-1 and those that are not.
This is because PD-1s are actually the cornerstone of therapy, of course, in IO, and have to be combined in order to advance patient care. Our intent here, as I show in the bottom panel here, is to extend patient survival. I'll talk about how we're gonna do that with TIGIT and the clinical plan and also ILT4, but this is essential. Let me now, though, turn a little bit to the differentiated profile of toripalimab. Toripalimab has significantly extended patient survival in a number of patient settings, most prominently in nasopharyngeal cancer, and its efficacy has been very broadly recognized. It was prominently featured at ASCO and also in Nature Medicine. Here you can see the progression-free survival and overall survival, which we have seen in nasopharyngeal cancer. Nasopharyngeal cancer is a rare disease.
It's a high unmet need. This is the first place that we will launch. Paul and his team are ready to go after this later this year as we get this done. This market potential is about maybe $100 million-$200 million, although I would say that we expect this to grow as these patients are recognized and they go on therapy, and the overall survival extends life for them. There is no FDA-approved IO treatment for nasopharyngeal cancer currently for these unfortunate patients. Paul and his team will be able to add this figure straightforwardly to the portfolio. The call points, as you can see here, are significantly overlapping, we are currently understanding exactly which physicians prescribe and find these patients in moving forward.
Let me talk a little bit about the differentiation of toripalimab and how it is slightly different from the other PD-1s in the market. When this product was developed, it was done with the idea of focusing on a unique epitope for PD-1. That is, as you can see here, the FG loop. This is a little different than what you see with pembro and what you see with nivo. When you create antibodies to one of these ligands, it's hard to predict exactly what part it will bind to. With this particular molecule, the team was focused exclusively on FG loop binding with very high affinity, primarily because FG loop binding induces internalization of PD-1 off the surface of the T cell. Here you see some very interesting data.
This is toripalimab compared with pembro in esophageal cancer. Here you see across the top PD-L1 high and PD-L1 low. Unlike pembro, you see in the upper right-hand panel, this product shows very good efficacy with a hazard ratio exactly the same as the PD-L1 high population in PD-L1 low. In the lower right-hand panel, you can see the PD-L1 low population for pembro. This is very interesting, and we are currently investigating mechanistically the basis for this with the research team. Now, let me make a few comments here about TIGIT. What's interesting is that TIGIT and PD-1 are both co-expressed on T cells, and they are both checkpoint inhibitors, right? When checkpoint inhibitors engage, you get immune evasion, and when they are blocked, you can get cytotoxicity.
In this slide 21, you will see very interesting mechanistic opportunities within the T cell, you can see SHP2 here. I think what's very interesting here is that PD-1 and TIGIT have crosstalk in overlapping mechanisms through SHP2. This, I think, is very interesting from the viewpoint of how they will work in conjunction with each other. We believe this makes toripalimab an ideal candidate to go with TIGIT. Our TIGIT, of course, is silent, as is some of the others that are moving forward successfully now in the clinic. Our Chief Medical Officer, Rosh, has now initiated study with the TIGIT, and you can see here we're in hepatic cancer, non-small cell lung cancer, small cell, and some other indications in conjunction with our colleagues in China at Junshi.
this is sort of a full press effort to understand how TIGIT will behave in conjunction with toripalimab in a number of clinical indications. We just got this going and look forward to updating you next time on how this data will read out. Lastly, let me talk a little bit about another product that we're working on, and this is the first product that has come out of Coherus' research effort, and this is ILT4. there is more going on within the tumor microenvironment, of course, than just checkpoints. what we are investigating here is the role of macrophages, particularly with respect to how to activate them. here's ILT4, and what's interesting is that ILT4 repolarizes M2's suppressive macrophages, you know, to one M1 inflammatory macrophages.
This has particular, I think, implications for non-small cell lung cancer and small cell lung cancer. ILT4 is a target that's under investigation by others, of course, in the arena, but you will hear more about this later. We intend to file this IND later on this year in 2023, and we're very proud of our team for bringing this forward. We believe that we have a very excellent ILT4 and have carefully selected, for example, the epitope. Let me touch upon YUSIMRY before I just close and offer you a summary. As you know, this is a very large market. There was a price increase at the end of this year. It was an $18 billion market. It's probably about a $20 billion market now at this time, and very large and addressable.
This is a payer-driven market that is primarily focused on economics, scale, the ability to supply. As you know, Coherus has invested in the last couple years in very large-scale manufacturing such that we will have a very advantageous cost of goods and be able to produce at a scale suitable for the largest PBMs and payers. Lastly here on slide 28, let me just make a summary before we go to the questions and Chris and chat with you a little bit. Our near-term product launches and innovative pipeline, I think is proceeding very, very well. toripalimab, as you can see this year, we believe will get approved in the first half of 2023. We will launch into that market.
Our TIGIT asset is moving forward in four different indications in the expansion study with our team. Our ILT4, which is our own proprietary product, will be filed later on this year. On the biosimilar side, which basically funds the development of the IO business in the oncology space, of course, UDENYCA, we're getting ready with the on-body device. That is going well. We are also proceeding with CIMERLI. We expect to have additional market traction there Q2, Q3, with acceleration after we get the Q code, as I said. YUSIMRY, we are poised to launch in July. We will have over 500,000 units ready to go at launch for that market.
That's a go big or go home market. Coherus has invested, I think, wisely for that. Lastly, the EYLEA biosimilar, with my good colleagues here and Dr. Strüngmann and all, we're looking forward to that product. We project it will be launched probably in mid 2025 after the patent skirmishes are resolved and so on. With that, Chris, we're happy to take your questions, and thank you.
Great. thanks so much for that, Denny. I'm gonna start with just a few, and then we'll open up to the audience for anything else. I maybe want to start with just the CIMERLI launch. It seems like some nice share trends that you're seeing there. What do you think is a reasonable market share opportunity for that product? Because I think you mentioned, you know, it seems like it's off to a even maybe even a stronger start than UDENYCA had, and I think you talked about share getting, you know, to into the 20s there. Is that a, you know, can you maybe look at the analogy of how we think about where this could go over time?
I'll let Paul comment further. Thank you for the question. Yeah, you know, we view 10% market share for any of these markets as a minimum. I think there's an advantageous environment for CIMERLI due to the fact that we have interchangeability and exclusivity. Our product comprises, I think, market formation for biosimilars, and there's a significant, I think, pent-up demand of, for the biosimilar conversion overall of the ophthalmology space. We've projected at least $100 million for this year. I would, of course, hope to do better than that. But I think that we're fairly bullish on this market, given the fact that we have both dosage forms, we have both strengths and so on. Paul, any further comments?
No, I think that's right, Denny. You know, the Q2, acceleration that we expect based on the Q code, we think will really fuel the back half of the year. We remain very optimistic. Our focus is on, you know, driving additional accounts and then going deeper with that, so.
The only other further comment I would make is I really wouldn't watch the weekly share trends or even monthly. I'd look a little more quarterly with the share trends to smooth out some of the noise, with that market.
And maybe just elaborate on competitively what you're seeing, with the other player in the space here?
Paul?
Chris, you're referencing the other biosimilar product?
Yes. Yeah.
Yeah, I mean, you know, we pride ourselves on being fierce competitors, as we demonstrated in with UDENYCA marketplace, and we're bringing, you know, our expertise with our account management, our capabilities and expertise with pricing and contracting and developing strategic partnerships. I think you're seeing that playing out, and we'll continue to do so. You know, but at the end of the day, Chris, we're focused on, you know, getting that LUCENTIS business first and less focused on, you know, the other biosimilar.
Yeah. I think that's right. One of the key things that gave us a success with UDENYCA is we hired an oncology team that had deep relationships with the providers, knew the docs, and really understood the market environment. Paul has recruited a team very similar here in the retinal space, again, with deep relationships and a deep understanding of the physicians. I think that's a very good way to leverage those relationships and really explain the value proposition to the physicians.
Okay. Then maybe just staying on the AMD market, bringing in a biosimilar EYLEA, I know this is when you were moving into the IO space before, I think you had made the decision to deprioritize that. You talked about the slides. Could you elaborate a little bit more what you kind of brought you back to this market, as we think about the in-licensing?
You know, I think the VEGF market is one of the more interesting commercial opportunities. As we launched, similarly, we had the opportunity to interact with a number of the key opinion leaders, and number of the providers. It became clear that there was a very significant pent-up demand to bring a biosimilar product into this market. At the same time, I think that the commercial synergies are really simply outstanding.
Yeah.
You know, we, you know, we really don't have to, you know, put any more boots on the ground. You know, we have key accounts, market access, a number of account managers already in the field. I think it's really a great way to leverage that. Lastly, I would say that most of the lift when you launch a biosimilar into these markets, of course, is in the first year or so.
Mm-hmm.
After that, you know, you don't wanna lay your team off or idle your team. I think there's the opportunity to give them additional things to do and put additional things in the bag. There may be even additional, more additional, ophthalmology assets that we pursue in the future.
Okay, great. Maybe the last question. Just as I think about the role that the high-dose EYLEA is gonna play in the market, how are you thinking about conversion and what opportunity is gonna be available for the biosimilars on the 2-meg as we think, you know, maybe beyond 2025? Is that a shrinking market, or do you think that a lower priced product can sustain a business there?
You mean, is the EYLEA market itself with the existing concentration a shrinking market, or how do we?
How are you thinking about the high-dose launch for Regeneron in terms of what impact that could have on the?
I don't know. Paul?
Yeah. Well, I think, you know, let's see how the high dose approval proceeds—
Okay.
—where the data, you know, nets out. You know, our market research and engagement with retinal specialists, you know, tell us that they still have some questions about the data.
Mm-hmm.
You know, not only the efficacy and where it fits in, but some of the safety data that comes out. We know that intraocular inflammation is of vital importance. You know, we're gonna look at the data closely, do our research, but, you know, this market is, you know, very, very big. It's continuing to grow. If retinal specialists continue to sort of treat and then extend, then we believe the EYLEA market will have sustainable large value for a biosimilar.
Maybe one more from me, and I'll open up the floor here. You mentioned this idea of leveraging kind of commercial footprint in the biosimilar business. As something about the HUMIRA market, as an example, could there be a similar opportunity there, I think about whether it's STELARA or just bringing other assets in to kind of extend franchises, or is this kind of more of a unique situation with ophthalmologists?
Well, I think, absolutely there's the opportunity to leverage. We have a very competent market access team with strong relationships with the payers. I think the HUMIRA is a bit unique. It's, it's over in Part D, and it's a pharmacy benefit product, you know, as opposed to a medical benefit product. You know, all else equal, I think that we really excel at the medical benefit side of the business, as we've seen, with UDENYCA. I also believe, though, that the relationships that we have developed, with the payers and the PBMs, will be, you know, put to good effect later this year as we go forward, with HUMIRA. With respect to STELARA or some additional assets, I think that, it's important, for the company to focus in key areas.
Our focus on the development side, of course, is the IO platform with toripalimab, the expansion with TIGIT and ILT4 and so on. We spend a lot of time looking at that. I think the biosimilars, you know, being the revenue source which funds that development, are another issue. I think it would be a bit off target to take another STELARA, you know, put it in the bag with HUMIRA, and then, you know, divert the company into Part D, you know, and have to put a lot of boots on the ground—
Okay.
—and all sorts of other, sorts of things. We think that focus in Part D, all else equals, is a good idea for us strategically.
Think of it more as a kind of a one-off in that vertical than the core focus being the IO portfolio in terms of the development.
Yeah. Well, you know, it's, it's hard to ignore an $18 billion market, you know?
Yeah.
When you have an approved product, I would say that. I don't, Paul? Yeah.
Great. Why don't we open up to the audience for questions? I got a few other topics, but let's give folks a chance to ask some stuff here. Otherwise, I'll keep going here. Can I get actually maybe just an update on toripalimab in terms of what's happening with kind of inspection and the PDUFA there?
Yeah. Dr. LaVallee, you wanna comment on that?
Sure. Thanks for the question. Yeah. We're very appreciative of JP Morgan to be starting really January 9th, when the China changed their policy January 8th. It's easier to address that. I think that the hurdle has been the travel restrictions to China. Yep. Now that that's removed, we're in active conversations with the FDA about how to get those inspections done. With Breakthrough Therapy designation, it's nice 'cause even though there's a backlog, we're at the top of the list with other folks with the same favorable regulatory designation.
Theresa, could you comment on the applicability of the clinical data to the BLA?
Sure. I mean, obviously last year there was a lot of changes to the outlook for bringing in. It was referenced in the Novocure Q&A about ex-U.S. development and applicability to the U.S. patient population. The FDA did take a large pivot. We have noted that. What we also have noted is that they have continuously said there's regulatory flexibility for areas like nasopharyngeal carcinoma, given that it's an orphan disease. There's no approved immunotherapies. The disease, the epidemiology similarity between the U.S. and Asia, the strength of the clinical data continues to show up in profound increases in PFS and OS. The strength of the data has really been recognized by the FDA. We very much look forward to having the inspections completed and at looking towards later this year.
Great. Great. Then on TIGIT, we had some recent data from Gilead. Just your perspective in terms of how that informs how you're thinking about the market, and I guess how you think about differentiating, you know, maybe your approach and your molecule versus some of the other TIGITs in development.
The ARC-7 data was particularly noteworthy for us. There's a lot of devil in the details for the science aspects of this mechanism. I mean, Denny described the importance of the crosstalk on the T cell between PD-1 and TIGIT that's been well-published. It's a rational combination to really maximally activate the T cell for antitumor immunity. There's a difference between a PD-1 TIGIT combination and a PD-L1 TIGIT combination, in terms of that interaction on the T cell, since blocking PD-L1 doesn't block PD-L2, which also can activate PD-1. The other issue with TIGIT are the differences between Fc-competent and Fc-silent. Ours is Fc-silent, akin to the Arcus- Gilead.
Mm-hmm.
Seeing antitumor immunity and efficacy in the ARC-7 was really important and noteworthy for us. I think overall, oncology is always been, throughout my multi-decade career, a highly competitive space, and the thing that continues to really advance agents is science-driven approaches. Coherus is very actively looking at the pathway and where it's relevant with the PVR expression. You'll note that in our clinical development, we have HCC, which has one of the highest levels of PVR expression. We'll continue to look at patient subsets and different pathways. As Denny described, toripalimab does have some unique features with high potency, a unique epitope, clinical activity in combination with chemotherapy in PD-L1 high and PD-L1 low. Leveraging those differentiation points to really look at the combination with TIGIT will be our approach.
Our partnership with Junshi is a really nice add because of their development in China and ability to really show high quality data in China, and doubling our ability to look across patient subsets with them in China and us in the U.S.
Yep. Great. I know you've got sort of studies starting this year. When can we think about initial data from those, you know, studies to get a better sense of how the profile is shaping up?
Yeah. This is where the partnership is great as well, because since the China study has been ongoing.
Mm-hmm.
Junshi is very good about publishing their data as they become available. We would look towards some sort of data disclosure later this year on the CHS-006 TIGIT program. Our data as it matures and particularly we have a lot of translational endpoints in there, so we would look to have that as it's available.
Okay, great. Other questions that might be out there? I'll keep going otherwise, give people a chance. Moving over to the HUMIRA market. I think this is been a topic of debate at the conference of how this is all gonna shake out. Would love just to hear, you know, just as we think about how this. I guess I kind of see the debate as kind of like how does 2023 look play out, what's the longer term market play out. Maybe can you just talk a little bit about how market formation you kind of envision this year with I guess Amgen launching in the near term, then another kind of wave of players coming in midyear.
I guess the heart of the question is this a year we should be focused on revenue from a Coherus perspective, or is this more about getting those formulary wins and getting the company kind of properly positioned for when maybe some of the volume frees up over time?
I'll let Paul handle that, particularly as a sticky question. Go ahead, Paul. How do we see it shaking out?
Yeah. I mean, obviously very dynamic, you know, marketplace. You know, there were two things really that are going to inform how it's going to shape out in 2023. The first thing is, you know, what formulary decisions have the payers communicated with respect to HUMIRA.
Mm-hmm.
I think what we've seen and what AbbVie's communicated is looks like HUMIRA is going to be in 2023.
Mm-hmm.
We don't know what's gonna happen in 2024, but at least this year they're going to be in, and they've stated, and they're also going to include biosimilars on those formularies. No indication, you know, of who and how many or if there's gonna be any preferential position. I think that that's a good thing, but I think what it's telling us is payers are gonna be looking to see, you know, how the biosimilars, you know, shape out in 2023. Our view is you gotta be, you gotta be in the game in 2023 if you wanna play, you know, in 2024 and beyond. That's gonna be our focus.
You know, as Denny mentioned, you know, we have stated unequivocally that we will be a, you know, a low price, high volume competitor here, meeting the two primary needs that payers have asked for, which is price and supply. So that's gonna be our approach.
The other comment I would make, Chris, is I think that there's gonna be teams that are geared towards high capacity and significant supply and guarantees and low cost, and teams that are not. While I think there's a lot of teams that have approved products that could launch and could go out and effectively compete, I think the competition will really be among teams with large capacity enough to satisfy the needs of the large PBM and payer groups.
When I think about formulary decisions that are made this year, is the view those are generally gonna be fairly sticky, so if someone's selecting you for 2023, chances are you're gonna be kind of their preferred partner, not just for a six-month window, and there's gonna be like swapping out of players or that that's more like a gonna be like a longer-term relationship that you're working with, or is it too early to tell?
I think it's too early to tell.
Okay.
The signals that we're reading is that, you know, if you're in the game in 2023—
Mm-hmm.
—you're most likely got a better chance to be in the game in 2024 because, you know, PBMs derive rebates, right? The more they move these formularies and these products, they gotta switch them around, and then they gotta adjust the rebates. They do like more stability with respect to that.
Okay.
Come 2025, when IRA comes into play in the Medicare Part D, you know, that's gonna be something that, you know, we're gonna see, you know, as this another step change, in that, in that timeframe.
Any sense of where, maybe you don't have to comment on this, but what is the TAM you can go after here? I know the branded market, you know, approaching $20 billion. You know, if we're thinking about 2025, 2026, what do you think that aggregate biosimilar market could look like in terms of revenue?
That's very difficult to say. I think two things. There will be intense competition in the market. There will be a significant amount of discounting. This is the biggest feeding frenzy ever to hit biopharma.
Mm-hmm.
I think that it's going to be just very, very intensely competitive in a number of dimensions. Just where that market goes, it's hard to say. I think obviously it's going to be, I would think, in the 2024-ish, 2025-ish timeframe, probably the fastest, most complete biosimilar conversion.
Okay.
I think it's really, gonna be, you know, very fun to watch—
From when it goes, it's really yeah.
—from your point of view.
Okay. Yeah. Maybe switching over to UDENYCA. Can you just talk. I know you've got the on-body, which is an important, you know, kind of next step for the franchise. With where the business is today, can you just talk about some of the dynamics? It seems like, you know, the competitive landscape seemed to have gotten a little bit more. Pricing was a little worse than I think we would all expected this year. Can you just talk a little bit, you know, how do we think about.
Well, you know, it is year five of, you know, of a biosimilar market. I think that we've done a very good job preserving price. As you know, we've we pride ourselves on managing our ASP. To be in year four, year five , you know, of a market and still have a strong ASP, and still have good market share, I think is quite good.
Mm-hmm.
Of course, we expect to do similar things with the CIMERLI market. Yeah, there's competitors come in. There's, there's not, you know, significant barriers to entry this far into a market. You know, I think that the key now to being competitive is additional presentations on body.
Yeah.
I think that's really important. We consider the on-body segment really to be its own market in a lot of different ways.
Mm-hmm.
There's practices with the oncologists and so forth, which really require an on-body device. Maybe Paul wants to comment a little further, but I think on-body is pretty essential to be competitive going forward.
Yeah. It's certainly the next catalyst for the wave of market share growth. You know, this is our device. You know, we published the PK/PD data, so, you know, we know we've established bioequivalence to the PFS. You know, really, I think driven by COVID, it's bifurcated the pegfilgrastim market really into these two segments. You've got the on-body segment and the prefilled syringe segment. Onpro's been very resilient at 45%, 600,000 units annually. So it's ripe for competition. The marketplace is hungry for an alternative, you know, to a brand that they've only had to use for several years now. We'll be able to compete on, you know, I think both device differentiation as well as economic, so that total value proposition will be compelling for our customers.
Should we think about that market converting fairly quickly? I'm just thinking at this point, we've had Physicians obviously used to using a biosimilar of a different presentation. How do you think about how quickly you can dislodge the share?
I hate to put you on the spot, Paul. You know, we took 50% of the PFS market in the first 12 months, which I think is pretty much breakneck speed. I don't think we'll do that with the on body segment. Can we offer any?
I think what I would say is, you know, at this point, you know, what our strategy has been, you know, to where we have payer access and where we've achieved that coverage.
Mm-hmm.
You know, we see the opportunity for rapid conversion, you know, in those particular segments, because we believe that we'll be able to just extend the coverage to our on-body device off of the prefilled syringe, and therefore that creates a more rapid opportunity for that % of that business. Assuming that, our assumption is that it will be billed against the same existing Q code for UDENYCA prefilled syringe, we won't really have that miscellaneous period.
Mm-hmm.
We could see faster adoption there. I think in those markets, we could see faster conversion.
Great. Well, I think we're just about out of time here. Maybe just do one last one. Competitively on body, any line of sight on what that landscape could look like for your peers coming in?
You know, we, you know, we think we're in good shape there. We hear rumors from time to time. As Paul indicated, we believe that we're the only team that's actually published pharmacokinetic data on this product. I think that's really where the rubber meets the road. pegfilgrastims are notoriously variable with their PK. Very, very difficult to achieve. They're even difficult to achieve with prefilled syringes, you know, head to head.
As you may recall, Chris, it took us two go rounds to get it right ourselves. I think that eventually others will show up. Given the overall, you know, market dynamics, you know, pricing difficulty of the PK, I don't know if there's gonna be other teams showing up with a on-body device in the near future or not. You know, people talk, but, I think we're the only people walking around with a device and PK data.
Yeah. Great. Well, obviously, very, kind of, exciting year ahead for you guys.
Yeah. Great year.
Look forward to watching the progress.
Thank you.
Thanks again for joining us.
Thanks, guys.
Thank you