Good morning, everybody . I'm Chris Schott at J.P. Morgan, and it's my pleasure to be introducing Coherus this morning. From the company, we have Denny Lanfear, President and CEO, who's gonna make some opening remarks, and we're gonna jump into a Q&A session from there with the broader management team. So with that, happy New Year, Denny, and over to you.
Thank you, Chris, and thank you once again for having us at the conference this year. Let me first, of course, apprise you of the forward-looking statements, which will address issues with the revenue projections, product development timelines, the various assets, the future of those products, and so on, and let me, of course, refer you to the company's regulatory filings. So today, what I'd like to do is, first of all, give you a flyby summary of the company. We've made substantial progress on our strategy of moving to an oncology company.
We are a revenue-stage oncology company now, and so I'll be happy to recap for you the progress that we have made over the past 2-3 years on that and review for you our core oncology business, which will include, of course, LOQTORZI, our PD-1, recently approved, as well as UDENYCA, our pegfilgrastim business.
Then also, I will take the opportunity to review for you our R&D outlook. In particular, my team and I would be happy to take questions with respect to casdozokitug, our IL-27 asset, as well as our CCR8, CHS-114, and our ILT4. We'll talk to you about the development plans there and our overall strategy to address the tumor microenvironment to provide the next step in patient survival.
I'll also do for you a review of our non-core projects, our ophthalmology asset, CIMERLI, which is moving along quite well, as well as YUSIMRY, and then offer you some concluding remarks. So we are now a revenue-stage, fully integrated oncology company with a robust portfolio of oncology products. Of course, we're very proud to have LOQTORZI approved in the United States, the first PD-1 for nasopharyngeal cancer.
I'll talk to you about that in just a moment. LOQTORZI really is an excellent PD-1, has put together a really impressive track record of efficacy and safety across a number of indications, in the hands of my partners, and we'll continue with that. And of course, UDENYCA.
UDENYCA, I'll talk in just a moment about the three different presentations that we have for that product, but we look forward to that product growing over 2024 and 2025. Those two products underlie our franchise in oncology, allowing us to develop, in conjunction with them, three key assets. First of all, casdozokitug, our IL-27, which is in phase II, as well as CHS-114, our CCR8, and then our ILT-4, which is still in preclinical phase, and I'll give you an update on all these. Dr. LaVallee, my chief development officer, would be happy to take questions during the Q&A.
We have been very focused in 2023 on delivering on our long-term strategy, and that is to launch products, grow revenues, and manage our spend, and I'm very proud of my team for having done that. First of all, with respect to execution, we are very happy with our regulatory developments here. We have five FDA approvals, and we have now launched four products.
18 months ago, we were here, and we were talking to folks about the things that we were gonna do. We have now fulfilled the promise of all of those products. The UDENYCA OBI was approved in Q4 2023. It took two bites of the apple there as we worked our way through a complete response letter.
But nonetheless, that's a very promising product and is going to address some 42% of the market share in the United States of some 1.2 million units. LOQTORZI has been approved and, and now is launched, and also the UDENYCA auto-injector approval and launch. So this is a very, very interesting presentation.
I'll talk to you about it in just a moment, of course, but, we see the auto-injector ultimately as the future of the pegfilgrastim business in the United States. We also have, of course, the approval and the launch of the CIMERLI, ophthalmology asset. CIMERLI has moved along quite well. We had some very good results here, quarter over quarter over quarter growth throughout 2023, and I think we're very satisfied with the results that we've seen then in Q4.
And then lastly, YUSIMRY approval and launch. YUSIMRY had a number of things that we finished up, and we went ahead, and we launched that. I will just offer you one caveat with respect to YUSIMRY is that, you know, things are gonna be a little shallow to flat until we get to 2025, and there's some additional reforms in the healthcare system, which will facilitate further uptake.
All these products, though, the key issue here is allow us to have long-term revenue drivers. LOQTORZI, this quarter, we've already had sales of last year, but we look forward to continued growth quarter-over-quarter, year-over-year for the foreseeable future, and also with UDENYCA, with the three presentations, and our non-core products, CIMERLI, and YUSIMRY also, consistently.
Lastly, financial discipline is very important to us, particularly with respect to the balance sheet. The company took on some debt prior to the FDA changing their position on the applicability of PD-1 data developed ex US. And so that left us in a bit of a, you know, a position where we're a little more in debt than we'd like.
And so we're really focused on two things that I'll talk about today. Number one, portfolio prioritization to optimize our R&D spend and save money without unduly slowing down progress on these assets, and also very, very tight SG&A management. We are very focused, as I indicated, on aligning our capital structure with the strategy.
And one of the things that we have the opportunity to do is to monetize ex-U.S. rights and other rights to our products without jeopardizing our core U.S. business, bringing in additional funds, which we would intend to apply directly to our debt structure, which I think is very, very important. One point that I would make with respect to portfolio prioritization, optimizing the spend, we announced last night that we have discontinued our TIGIT asset, and we have given that back to Junshi. And it's not that TIGIT is not a good asset or TIGIT will not find application in some cancers.
It's just, for us, it's a highly competitive space. We felt that our funds were best spent, for example, on our IL-27, which we have global rights to, and which, we think is first in class and has some very promising data, developed. But I, I would just point out that tough decisions are necessary in this business and, you know, Junshi's been a very good partner for us, but regretfully, you know, for us, it was, it was time to part with that particular asset.
So, I'm very happy about the growth we've seen, in 2023 on the revenue side. We pre-announced revenues, just last night. We have come in at the upper side of our, range, the... Which was $250 million-$260 million. We're gonna come up on nearly around about 260. Very happy about that. Our Q4 is about $90 million. Quarter-over-quarter revenue growth was similarly after garnering the Q Code in April of 2023, as we promised.
Quarter-over-quarter net revenue growth with UDENYCA. Also, I think with respect to UDENYCA, we have done a very good job at managing the average selling price, which directly impacts reimbursement. And we now have 3 presentations to provide long-term market share increases. With respect to LOQTORZI, the distributors are stocked, the patients are dosed, the sales ramp's been initiated, and we've recorded modest sales already in 2023. Now, let me talk about the core oncology business. This is our UDENYCA on-body injector. We're very proud of this device.
This was something that was very difficult to develop. We spent substantially to develop this and reengineer it. This is a de novo device with the most modern of technology to address the issues. This cost us about $25 million-$35 million to develop this. What we did is we took the opportunity to really see what the patient experience was with the current devices that are available on the market, and to offer something that was much better.
That is, the patient interaction portions of this are far better, the ability for the patient to understand just what the device is doing, if it's full, if it's going off, and whatnot. The key benefits to this product is that it has an injection time of about 5 minutes versus 45 minutes for the innovator device.
Secondarily, what's very interesting about this device is the needle is not inserted until the time of administration. So the needle inserts, the device goes for 5 minutes, and then the needle retracts. So what you don't have is what you have, like, with the current device, whereby there's a cannula that's inserted, the patient walks around for a day with the cannula, it's irritating and so forth.
You know, and this is gonna offer the patients much greater comfort. We've also made improvements on the adhesive of this device. One of the key issues here is you wanna make sure it stays on. You know, these patients can be taking showers and so on. And so this is a very important part of the triumvirate of products.
What you see here for the administration of UDENYCA are pegfilgrastim. Of course, the workhorse of this particular segment is the prefilled syringe. This is really for patients and physicians who they have the opportunity to come back the next day post-chemo, 24 hours. And many times, depending on the indication and the patient, the doctor wants the patient to come back and then administer the pegfilgrastim, so this has been a dominant treatment paradigm so far.
You know, you know that the patient was administered. However, there's other patients who are much more active, and these patients, you know, very modern, perhaps, you know, they're moms, and they wanna go and have their auto-injector and pull it out of their purse and administer it, you know, during their kid's soccer game or something.
So there's a certain segment of these patients in which the auto-injector is very, very convenient, so that's meant for them. And then lastly, there's the on- body, and this really combines the best of both worlds. You put the device on, and the device goes off some 24-25 hours later. And this is for patients who are unable to come back to the office. So maybe they live remotely, 50 or 100 miles away, maybe they're, you know, on an Indian reservation in, you know, Arizona, you know, 50 miles away and can't drive back.
So our strategy here with this really is to have all three presentations and present a total solution for the physicians and the patients, allowing us to do two things: drive long-term share growth and long-term profitability in this particular segment, as there's now ongoing consolidation. The UDENYCA business is strong and is growing.
We recorded quarter after quarter market share increases, you see here, from 11.5% in Q1, 12.2, 16.5% of the trailing four weeks for 2023 was about 17.3. We haven't bottled up the total number for the market share for then, but this is really a great business. This is I think this really is something we'll be around for a long time. Chemotherapy is not going anywhere.
People are gonna need these pegfilgrastims for the foreseeable future. The other thing that I would say, I'll make two key points here. First of all, our auto-injector is a new paradigm, so that's taken a while to get off the ground as we work through issues of the insurance coverage and changing the paradigms with the patient and the physicians in the clinic.
But secondarily, we're also making very good progress with respect to increasing our payer coverage. One of the advantages of having these various presentations is the payers are much more willing, of course, to provide coverage, and we're doing well on that. But the big thing we're really excited about, of course, is LOQTORZI. I just want to commend my team for this.
It was, it was very difficult working through, COVID for such a long period of time, for the FDA to get to China for all the requisite inspections, both the CMC inspections, and the clinical inspections. We are very proud, and we are very happy to bring this product to these patients who have no therapy.
There is 2,000 patients or more in the United States with nasopharyngeal cancer, and they don't even have chemotherapy on label with the FDA. Our focus at Coherus is always to be there for the patients, and we think this is really, really important. This is not, a enormous indication, but, you know, we think that $200 million opportunity, for the foreseeable future is really excellent. This is a very, very stable market.
We intend to own this market, maximize this market, and we see this going on for the foreseeable future. Commercially, what's very interesting about this, it allows us to leverage our footprint. There's about 95% overlap between our pegfilgrastim business with UDENYCA and these LOQTORZI users. This is the only IO treatment with preferred Category 1 under NCCN.
That is a very big deal. I want to thank my CMO, Rosh Dias, who actually worked with NCCN on this, but this is great, and we are only a preferred NCCN regimen for second line. We have all lines of therapy here in NPC. 2,000 treated patients, and what's really gratifying for us that we have seen is the reaction of the physicians who are committed to these patients and the patients themselves.
We are focused commercially on very rapid LOQTORZI adoption. There's about 2,200 physicians, which present about 80% of the market. We are quite focused on getting to these doctors. We spent a lot of time over the last 2 years reaching these docs with the KOLs and getting to them. We understand who the early adopters are, the non-early adopters.
The chemo users are particularly important. That's about 60% of the patient population, and this drug can be used in conjunction with chemo, which means these patients can go right on therapy. Also, as I put on the right panel of this slide, we also have developed sophisticated tools to identify these patients, the ICD-10 codes. So when a patient is diagnosed in a physician's office with NPC, this code is immediately registered, okay?
We get that ping right there, and we are able to have an account manager, a salesperson, show up in less than a week at that physician. So just, just think about that. That's an early warning system to identify these patients as they come out. And of course, we have focused a lot on engaging the patients and educating the patients.
Rare diseases are about engaging and educating patients, and this is really where we have invested while we have waited for approval. We had NPCfacts.com. We had thousands upon thousands of hits to that. We have now identified over 2,100 NPC patients and their caregivers, and so this is, this is why we are, I think, very optimistic about our ability to get into this market, own this market, and very quickly bring it to fruition.
Let me talk a little bit now about the R&D outlook and our pipeline. So, one of the key things that we want to accomplish now that we have LOQTORZI approved, is to use it in combination with tumor microenvironment agents to extend cancer patient survival.
We think that the next step and the next generation in survival benefit for patients will come from the TME, and you can see it here with the graph that's illustrated on the left side of this diagram, but you see where each of our products are. Casdozokitug, we'll talk about, and the IL-27 in just a moment, as well as our CCR8, but this is really our focus.
You know, I talked about the discontinuation of TIGIT, and the reason for that is because we are focused on first-in-class and competitively positioned assets that have very strong data, right? And I think we'll show you a little about data coming out with casdozokitug now. So this is very interesting. Here we go. First of all, we have LOQTORZI, which is on the left side.
This is, of course, you know, a checkpoint, and there you have a T cell, right? And casdozokitug generally speaking diffuses some of the anti-inflammatory aspects in the TME, and I'll talk about that in just a second. CHS-114, our CCR8, addresses Tregs, right? And Tregs proliferate, and what they do basically is turn off immune response. Then, of course, our anti-ILT4.
So we're happy to take a few more questions about this from Dr. LaVallee here during the Q&A period. But the mechanism of tumor suppression, really, first of all, is IL-27 upregulates checkpoint receptors. PD-L1s, TIGITs, LAGs, and so on. And you can see that by the data diagram below. It also down regulates pro-inflammatory cytokines, right? And lastly, it constrains natural killer cell immune surveillance. So these are three key MOAs that make IL-27 very promising.
And IL-27 for us is focused in two key areas. One is lung. Here you see the non-small cell lung cancer data, and second is liver. What's really interesting about this IL-27 asset, casdozokitug, is demonstrated monotherapy activity in lung, which is really rare. Something like TIGIT, for example, does not have monotherapy activity, and this really bodes well for it.
We've had 2 confirmed partial responses so far, 22% ORR, right? And we've had clinical demonstration of proof of mechanism. And now on the liver side, we have an even more impressive data, and here we see some data generated in conjunction with atezolizumab and Avastin. And you can see here we have 50% of these patients looking good.
We have 27% ORR, and what's interesting is next week at ASCO, we'll have a more mature data set to show you that we're, that we're very, very excited about. But just take a look at these green bars and the response that we're seeing out of this product. This is a very, very high unmet need. Let me just stop for a second here on our overall strategy for developing casdozokitug.
It isn't a small indication, but we have high ambitions for really expanding it outwardly. First of all, we just announced a deal with INOVIO, and what we'll do there is basically supply them drug, and then they will do a phase III, and then when approved, we'll get on the label. So this, this basically allows us to move forward with these assets with LOQTORZI, I should say, clinically, with only the costs associated with supplying drug.
What we have found, frankly, is that there's a lot of teams who are very enthusiastic about using LOQTORZI in conjunction with their novel agents, and I think you will see more of these types of arrangements and partnerships as we go forward in various types of moieties, whether they be ADCs or TCEs or whatever.
Top right, you also see our partner, Junshi, a very good partner. Junshi is also involved in moving forward with LOQTORZI in the United States in conjunction with BTLA in small cell lung. And that also would be a very significant indication if approved for us. And then, of course, as I just spoke, we also have our own TME agents. So we're very excited about our pipeline.
There's a number of things that are gonna be reading out over the next 12 months. Our launch of NPC, a number of research collaborations reading out in Q1. And then with casdozokitug, this HCC liver data coming out in Q1, the small cell data coming out later on in the year. With the CCR8 molecule, that's in phase I. We'll continue to see data in the first half of this year.
There'll be a meeting, a large oncology meeting that you'll see that, I think, by mid-year. And then our IND filing is on track for our ILT4 CHS-1000. Let me talk briefly about our non-core products before we go to the questions. We're doing well with CIMERLI, as I just indicated.
CIMERLI has now accumulated over $125 million in net annual revenue through Q4, about 29% market share. It's actually probably marginally higher than that. We're doing very well in the class competitively with this product. Over 190,000 doses shipped since launch. And this is really, really important with respect to ophthalmologists, becau se ophthalmologists have been burned time and again by novel agents that come on the market, and then what happens is that, you know, you get 10,000, 20,000 patients treated, you start seeing ill effects and adverse events.
So this, what this has allowed us to do, really, is to instill confidence in this product, confidence in our company, that we have a high-quality product. This was the first product with full interchangeability, both dosage forms, all indications. So this really puts us in a very strong position in the ophthalmology world. With respect to CIMERLI, we were the innovators of the low WAC strategy. We, of course, did a deal with Mark Cuban Cost Plus Drug Company. I recently talked to Mark in Dallas.
We're both very happy with the way this is proceeding, contemplating ways to expand that relationship. But as I indicated before, you know, I think that the Humira biosimilar market is gonna be tough, you know, out and through 2025, as we work our way through these formulary issues and so on. Let me just make my concluding remarks before we go to the questions. We feel very positive about how we have executed the strategy over the past three years.
Two years ago, we announced our PD-1 deal with Junshi at this conference, so we are now two years hence. We have an approval in hand. We have a very nice indication. We are actually selling and shipping that drug. We have done, like, another deal since then. The Surface Oncology merger brought in a number of very promising top-level TME agents.
I think we have a very strong pipeline. We've gotten two different presentations of UDENYCA approved, the on-body, plus the auto-injector. We've launched CIMERLI, we got that approved. So I think the last two years in particular, we're firing all cylinders as far as the execution is concerned. We have now seen strong growth quarter after quarter after quarter after quarter throughout 2023. We look forward to that in 2024.
Once again, I would emphasize our fiscal discipline. We run a very tight ship at Coherus. You know, we did a ref and some restructuring last year. We're looking at ways to drive the ship back to cash flow positivity in the second half of this year. It's very important to us as we look at ways to do that. Thank you very much, and we're happy to take some questions.
Great. So anyone who has questions can maybe raise their hands, and in the meantime, I'll throw out a few here. I guess maybe bigger picture, you highlighted a number of interesting assets on the oncology front. Talk a little bit about how you kind of think about balancing developing these assets relative, I guess, just being cognizant of the operating expenditure base, the goal to get to profitability. How do you kind of manage that tension, I guess, between the two?
That's a great question. I think that we're very cognizant of the development costs for all these products.
Mm-hmm.
And as you saw on one of the slides, you know, we, we have now other folks that are developing LOQTORZI in conjunction with their agents at minimal, if any, cost to us. So the INOVIO agreement was the first one. There's a few more of those queued up. As I indicated, Junshi's also going to develop LOQTORZI in the United States for the indications.
So it'll it allows us really to take a, Chris, to take a very targeted focus in our development. And, and we intend to continue to build our revenues going forward, and, and really bring alignment really back into our, our, our cost structure and our expense structure without slowing down development.
But I think that the underlying potency and efficacy and safety of LOQTORZI puts us in a very strong position for some of these partnering opportunities. And then secondarily, I would point once again at our ex-US opportunities. We have global rights to all of our TME assets. We came up with the IO for ourselves, so we have the opportunity to monetize certain rights ex-US, and again, bring additional capital.
Great. Maybe one, another one for me. On casdozokitug, just maybe elaborate a little bit more tox profile, we think about the drug. Seems like there's some promising early efficacy-
Yeah.
Maybe-
Maybe Dr. LaVallee can address casdozokitug?
Yeah.
Yeah, so I think it's an incredibly exciting program-
Mm-hmm
... in that we've seen immune activation in patients-
Mm-hmm
... as well as single agent responses, and the safety profile has been well-tolerated, no limitations, good combination with atezo-bev-
Mm-hmm
... as well as monotherapy. So we don't see any limitations in terms of combinations broadly. So if we're looking at partnerships, even with TKIs or ADCs, all of those with the immune activation really lends itself. And the other thing that we're really excited about casdozokitug, and your question about development spend, I mean, I think the thing that's underappreciated in oncology is the hardest thing is who to treat.
So when we talk about activating anti-tumor immunity, that applies broadly. But even with PD-1s, we have hot tumors. Well, how have we characterized those? Where do we go with the other agents? And for casdozokitug, the preclinical data and disease linkage really told us liver and lung were the places where activity was seen, and that's translated to the clinic. We have a very focused development, and I've seen early signs of activity, so I think it's incredibly exciting.
Great. And can you just elaborate on the next steps to development? Have you... And you've got a couple data, you know, kind of readouts, some maturity coming this year. But kind of-
Yeah
... where do you go once you get these readouts out of the way?
So these, again, give us a great signal, so to really add LOQTORZI. So clearly, the data that was presented in December and the lung cancer data that Denny shared with you, Surface had originally written the protocol and had five patients treat it with pembro. Rosh's team has amended that protocol, and it's open now with LOQTORZI.
Mm-hmm.
So second-line lung cancer with LOQTORZI. And then after we present the data next week on the HCC data set, really setting it up with the atezo-bev, looking at adding LOQTORZI, given that it's shown such good activity in HCC.
Mm-hmm
... that developing it within our own pipeline is where we'll take it.
Great. Great. Questions out there? Otherwise, I'll keep going. Maybe on, on LOQTORZI.
Yeah.
Can you just, following the approval and now NCCN coverage, just how do we think about the ramp of this drug? How quickly can you get to those patients?
Paul Reider, our Chief Commercial Officer, would be happy to address that. What do we... What's our thoughts on the ramp, Paul?
Yeah, because there's no FDA-approved products, you know, we believe we have a, you know, clear shot to be able to implement LOQTORZI in addition to the chemotherapy regimens. So the other important thing that Denny mentioned is we have indications for all line of therapy. So you've got patients today, you know, in first line getting chemo only.
We'll want to add LOQTORZI to that regimen. Other patients are receiving second line, third line. Those patients, if they're getting chemo only, we can add it to them. They're sicker, though, when they're in the second, third line. Duration of use might be a little bit shorter than the first-line patients, but that's really the focus, Chris.
So, given the tools that we have to identify these patients and the receptivity, you know, by the oncologists, for this product, we anticipate no payer concerns. We would expect a fairly, you know, fairly, you know, steep ramp here as we gear up. Over time, those second-line patients, third-line patients will sort of wash out, and then the first-line patients will become the dominant, you know, portion over the next few years as we continue on.
Great. On maybe just pivoting over to UDENYCA, the on-body device, and it seems like you've, as you highlighted, it's got a really nice profile. How do you go about, I guess, maximizing the value there. So is it from a payer level, is there a willingness, you know, an acknowledgement this is a kind of a better mousetrap, or is the goal to, you know, kind of get the physicians drawn in, and that'll help on the payer side?
Yeah, I would characterize the approval of the UDENYCA on-body device as an enthusiastic reception.
Mm-hmm.
You know, Paul can comment a little further, as far as the market. This is, this is something that folks, the oncologists and the patients have waited for, for a long time. The existing device has been out, you know, a decade or whatever. I, I don't- we don't perceive any impediments with respect to, the payer coverage. Should drop in right behind, the PFS. It has the same WAC as and, and, and so on, as the, as the PFS.
Mm-hmm.
I think if anything, we'll probably find ourselves selling this as much as we can make of that product as best as we can. Paul, any more further color on the market?
You know, I would just say, you know, we're in year six of the product life cycle. The focus is on, you know, profitable growth-
Yeah
... right? So Onpro's got 42% of the share, but we're gonna be driving profitable growth in the segment. We are gonna be entering this year with almost double the payer coverage that we had in 2023, and that's because we've had such stable business with our base core PFS.
Our ASP management has been stable relative to the competitive set, and we have the portfolio. So, you know, we're in a good, better position this year, and we've written those contracts so that the on-body will fall right, you know, right behind it. So that work is ongoing, and so it should be available, you know, as we have the standard contract.
Yeah. I would just add one other point to Paul's remarks. You know, we have always played the long ball with respect to the UDENYCA franchise, which was sometimes very difficult. You know, we've had quarterly calls where we had erosion of share-
Mm
... and pricing and so forth, which were, which were pretty tough. You know, we got down to, you know, you know, 10.5% share in Q1 and so forth, and now we're growing again. So I think that you have to take a long-term view. We're very careful about ASP because we wanted to have a very strong ASP upon which to launch the on-body device. But again, we're in it for the long haul with this market, and I think that strategy has really paid off, even as others have come in, been aggressive, and had to exit the market because of their cross-cutting.
Do you think the on-body product can take the same amount of share relative to the innovator that we saw in the other presentations?
Well, you know, I think that the first year or the first two years of UDENYCA launch is a pretty tough act to follow. You know, we took 50% of the PFS business in the first year. You know, we did $356 million the first year and $476 million the second year. So that's I don't think we'll do quite that well. We won't get half of it the first year. I think that's a pretty high bar, but I think we'll do very, very well. And I think that we have really good relationships and a very good understanding of the markets. And our reputation is very good. You know, people know we're in it for the long haul.
Can I ask just a question on the market dynamics? You mentioned 42% are on on-body. Is it typically physicians are using kind of like one presentation or the other, or do you find the practices using both? I'm just trying to sense of, is this, are these new practices you have to break into, or is it just leveraging existing relationships?
Yeah, I think most of the accounts use both modalities-
Okay
... right? Because they have patients that wanna come back to the office, and they have patients that don't, so they serve both. However, with COVID, you know, staffing shortages in clinics became a real problem, and so-
Mm
... we did see some movement in some, you know, practices that moved more, from a waiting standpoint to the on-body just to reduce, you know, patient intake because of staffing issues. But they typically use both modalities.
Okay.
That's why, as Denny mentioned, you know, the features of this device-
Yeah
... you know, we believe will, you know, all things being equal-
Mm
... will lean the customers and the patients toward our UDENYCA device.
Yeah. You know, I think that COVID was really sort of a watershed event in the pegfilgrastim market. As Paul indicated, what occurred was, you know, they didn't want the patients coming back, and so on-body was a very convenient way to avoid that.
Yeah.
What they did subsequently was then change all their practice management systems and the way they did things and how they scheduled the patients, and they have stayed with that even post-COVID when the patients can come back. So, this really now is the first time that we'll be able to go in and conjunction with those practices in a synergistic way and work through that. That's why I think we're pretty bullish about it.
Yeah. Can I make one more comment?
Sure.
So it's just... You know, so with that as the backdrop, the auto-injector device-
Yeah
... is the new modality. That was the, you know, the new innovation here. So that's what's, you know, occurring right now with our presentation of three different options and giving the, the doctors and the patients, you know, optionality. So if they want a, an at-home injection experience, now they could either self-inject if they want in under 10 seconds with the auto-injector, or they could have the on-body device. So we're weaving all this in-
Mm
... as we're innovating, you know, the pegfilgrastim class.
Yeah, yeah, a lot of opportunity there. I, I guess, just last question on this: pricing, do you think that there could be more pricing pressure here, or now that you have this full suite, are you maybe more insulated from that than we've seen in the past?
... Well, you know, pricing's a tough question. The issue with biosimilar markets is you have to be, you have to be very careful of pricing, and you occasionally have market entrants or market participants who are very aggressive with pricing, even though it has a short-term impact. So as I said, you know, our desire really is to have longevity, durability, and long-term profit maximization, you know, maximizing the area under the curve, and the way to do that is with these three devices. I would just point out that, you know, as others have exited the market, the payers have come to us and said, "You know, give us...
You know, please give us an agreement." We had a large payer last year who did such a thing, who really needed to fill out their formulary. So I think overall, the Pegfilgrastim market is, you know, as Paul indicated, year six with the biosimilars, has reached a level of maturity and stability, and others, you know, will come in. But I think everyone will have to sort of stabilize their prices to stay in business, or else you have to exit. So I actually think it's a, it's a fairly stable, to up situation, and we should be able to get some fairly decent market share gains, next year.
Great.
I should say this year, in 2024.
Yeah. I may have last question. On CIMERLI can you just talk about... It was a very strong launch. You had, you know, 30% share, I think, was the 3Q update. How much more share and opportunity is there to go here? Like, where can you push this to as we think about 2024?
Well, that's a tough question. You know, we're very pleased at the progress of CIMERLI and how it's done. I think our ability really to field a team and have a very sophisticated set of information tools to understand who's prescribing and not, and what the impediments are not, and how to profile the doctors has really paid off.
I can tell you that we'll continue to convert the existing Lucentis market, even as Roche moves that market up to Vabysmo. But I think there's also significant market share opportunity with respect to the reformulated Avastin. You know, reformulated Avastin is really in a space that should have belonged to the biosimilars regardless.
Mm.
I think that as we go forward with Lucentis biosimilars and then the Eylea biosimilars, I think that the reformulated Avastin space will continue to shrink, and I think that's where, if not the share growth, the unit growth really will come from over the course of 2024.
Great. Well, I think we're just about out of time here. Really appreciate the comments today.
Thanks, Chris.
Thanks for joining us.
Thank you, all.