Excellent. Well, listen, pleasure to have Coherus Management join us. I feel like you guys have been very active. You guys have been very busy. I remember, early on, Denny, it used to be Neulasta and nothing else when we used to talk about, but there's a whole lot more to talk about today. Maybe that might be a good place to start. Why don't you kick us off and maybe redefine for us? 'Cause for a lot of folks that have known Coherus in the old times, when it was sort of more limited in its focus versus where are things now, and what's on top of your mind?
Great. Well, first of all, Umer, thank you very much for being at Evercore this year. We, we appreciate it, being with you down here in Miami. I think we've made tremendous progress in the last two years, on the development of the strategy of the company and our movement into immuno-oncology. Yeah, as you know, in 2019, we launched UDENYCA, which was a biosimilar to Neulasta. We did great that year, took 20% market share, printed $356 million. Next year, we did $476 million, just, you know, actually barnburner, for prior to COVID. During that period of time, we decided to take the core competencies of the company and leverage them to immuno-oncology. We looked at, oh, probably 15 or 20 different PD-1s being developed across the world.
We did head-to-head testing with proprietary assays, and we came down with our next generation PD-1 toripalimab, which has now been approved in the United States for nasopharyngeal cancer, LOQTORZI. My good friend, Paul Reider, my Chief Commercial Officer, will give you a rundown on the launch. But we're very, very excited about it. It has a novel mechanism of action. Dr. LaVallee, my Chief Development Officer, can tell you about the binding site and how it's different from Keytruda and a few other things. We've continued to monetize the proceeds from the biosimilar franchise with this year. In October of 2022, we launched CIMERLI, which is a Lucentis biosimilar. Did very well with that. We're currently at about 25%-30% market share. Q2 over Q3, we saw a 50% increase in sales.
Although we launched in October of 2022, we really hit our stride, I think, after April of this year, once we got the Q- Code. So Paul can tell you about that, but I think that's a, that's a very nice market. Once again, it's a Medicare Part B market, where I think that's probably the best place to play in the United States with respect to biosimilars. So going forward, with LOQTORZI, with nasopharyngeal cancer, we have all lines of therapy for that. There's about 2,000-2,500 patients a year. It's about a $200 million space. Our view is that we will totally dominate and occupy that space going forward for the foreseeable future. We don't see other PD-1s coming into there. Toripalimab, or should say LOQTORZI, can be used in conjunction with chemotherapy there.
And so, first order of business after we launch next month will be to go after those patients that are on chemo, and so on. B ut very exciting, and overall, I think that the strategy really is moving along quite well. We finished the Surface Oncology merger last summer. We acquired two very promising assets there, an IL-27 and a CCR8. Dr. LaVallee can tell you about. But overall, I would say the biosimilar franchise is moving forward nicely, increasing sales quarter- over- quarter, approval of the first next gen PD-1 toripalimab for NPC, and I think it's all coming together, I think. So 2023 is pretty good. I think 2024 is gonna be a again, another positive year for us.
Got it. And maybe, Denny, remind us the strategy. I know you guys are annualizing at about $300 million run rate, as of the latest quarter. Where do you see the break-even happening? And is it the strategy that there's some legacy expertise on the biosimilar side, continue to grow that, but then add in some of the novel programs to really juice the path to upside? I s that the strategy here?
Well, I think, first of all, I wanna make the point that we are very, very cognizant that we need to bring our revenues and our expenses into alignment. 2023 was you know, a tough transition year. Early on the year, we had UDENYCA, about 10.5% market share. It's about 16.5% now, so that's growing nicely. So that's on the upswing. At the same time, in 2023, we managed to reduce our SG&A plus R&D expenses year to date to end of Q3 30% over the previous year in 2022.
So the way we kind of go forward, Umer, is that, you know, every year in Q1, we take a look at the business and what we have to do in terms of, you know, pulling the levers and turning the knobs. Last year, in this past year here in 2023, we did a RIF, did a lot of cost controls in Q1. Q1 this year, you know, same thing. We take a very hard look at the organization, especially in the face of the LOQTORZI launch, and then, of course, the ONBODY device, which should get approved here, we're thinking, by the end of the year.
So we get that out of the way, take a tough look at everything in Q1, see where we have to make the adjustments, but we look forward to driving the shot back to cash flow positivity in the second half of the year. You know, we think that that's very doable.
Got it. M aybe a better way to ask is, January first, before this last cost cut, where was the OpEx run rate, as it was R&D run rate, and where is it now?
Can't answer that question for you.
When I say now, I mean Q3.
Yeah. Well, one of, one of the key things about, you know, R&D, though, is the key point I wanted to make, because people take a look at that with respect to the statements, is that, R&D also includes a lot of manufacturing costs. So if you ever look at our R&D number and it looks large, it's not because we're off doing a lot of clinical trials or spending on things, which, you know, we do some, but the majority of that typically has been manufacturing. So prior to approval, all the process transfers and the manufacturing, for example, you know, that, that has to all be expensed. With toripalimab, for example, we were quite busy in the past 18 months taking that product from China to manufacturing in the United States. So that all had to be expensed, and that showed up on the R&D line.
Now that it's approved, you know, all those kinds of costs will all be capitalized going forward. Similarly, we know we had costs with, you know, YUSIMRY we had costs with the ONBODY device, you know, that all had to be pumped into the R&D line. So we're very, very cognizant of controlling our R&D, and next year, in 2024, I think that I think we're in the, the, I don't know, maybe the $10 million-$50 million range as far as actual clinical trial costs. And so I think we're now that we're past a lot of these manufacturing shifts, I think we're able to control the R&D line very well.
If the top line grows, let's say, $100 million, do you think that's break even, or you need more than that?
The top-line growth for on top of the sales?
The $300 million becomes $400 million. Do you think that's break-even, roughly?
You know, that depends. The issue that you run into with respect to the biosimilars is the margins. So our gross margins are great, that is, the delta between the net selling price and the actual COGS.
The biosimilars, you know, including in Part B, are a little choppy with respect to pricing, you know, for two reasons. You know, first of all, with respect to something like UDENYCA, you can't really control exactly which segment it goes into, whether that's 340B, non-340B, or the clinic. And each of those segments can have very differing, you know, margins and profits. And the second thing is, folks will come along into those, you know, areas, and they'll come in with low prices in a transient sort of way and drive prices down, and you'll have to deal with that. So over the past year, for example, Sandoz came out with some very low pricing, you know, with Ziextenzo, their pegfilgrastim. You know, very, very aggressive.
They gained share for a short period of time, but then their price got so low, their ASP spun down. They've now exited the market, right? On the other hand, our ASP with UDENYCA is up around $1,800. It's 2x Amgen's, with, you know, with Neupogen, which is about, you know, $800-$900, and so on. So, you know, you have to be very cognizant of your ASP in these markets. And really, what you want to do, and what Paul's team is focused on, he can tell you about it, is really profitability. So, you know, now that we have a shakeout in the pegfilgrastim markets, and now that we've taken additional share and our ASP is strong, and we're launching these other presentations, now our focus really is on profitability.
So I can't really answer your question because it's not really a static sort of thing, but I think that the trajectory would get you there. Yeah.
I guess just let me just translate that. What you're saying is, you can go from $300 million-$400 million in revenues easily. Whether or not you go at the same margin is a different conversation. Is that what you're trying to say?
Yeah, I, I think that's exactly right. You know, there's $400 million, and there's $400 million, right?
I see.
You want the $400 million with the good margins and the profitability.
I see. Okay, so maybe that might be a good question. Like, how do you guys think about that internally? Because I don't think that's well understood by The Street. 'Cause I was just doing this math more like a branded product, that, "Oh, extra $100 million, this is the run rate. It should work out." But what you're saying is, you're gonna be $500 million, and you may not produce much additional profit.
I think you have to be very careful with it. So with respect to UDENYCA in particular, our strategy has been to preserve average selling price, bring out the other presentations, and use that high average selling price as a way to launch those nicely. And so, you know, we do that. We have the auto-injector and the on-body now, so we'll have three presentations. If you get too aggressive with your pricing, you can get market share, you can get sales, but you won't get profits, and you can spin yourself out of the business. So that's to be avoided. Our view of UDENYCA is to maximize the area under the curve for the long term. We wanna be there for a very long period of time. We spent $25 million on an auto-injector, right?
The reason we did that is because we see that market moving there in the long term. We spent about $35 million on the on-body. Very, very similar. We wanna be the people with all three presentations and maintain that tail for that business for the long term. Your point, though, is well taken. You know, one of the very nice things about LOQTORZI as a product, it's an innovative product with very strong margins. If, for example, if you sell a vial for, you know, $10,000, you pay your partner 20%, it's $8,000. Your COGS is a few hundred dollars. You know, you've got some very strong margins there.
Right.
You got, you know, 75% margins. And if you build that business up, f or example, we expect to build that business up to $200 million at peak over the next two or three years. Then, you know, you basically have an annuity going out for many, many years, you know, with some price increases as it goes along. So the counterbalance to the more volatility in the biosimilar, with the biosimilar, revenues.
Is there a general rule of thumb emerging that first product enters at a 25% discount to the list, second one comes in an additional 15% discount, third one comes in an additional 15%?
With respect to the biosimilars?
Yeah. Or i t's not quite. 'Cause I know in HUMIRA , somebody came in at down 60% all of a sudden, so depending on the market b ut is there a general rule of thumb emerging, or not quite?
Well, it's a tough question. You have to keep in mind that the Medicare Part D space, right, the pharmacy benefit space where Humira resides, is much, much different than the Medicare Part B space. Over in D, you know, you have to deal with the payers and the PBMs and, you know, a lot of rebating and so on. And you've seen AbbVie very successfully operate within that system to maintain 99%, you know, market share, even though others came out with some discount, right? So that makes life tougher to compete over on that side. Now, on the Medicare Part B side, I think it's a bit different. To the degree that the product is viewed as interchangeable by the physicians, and, you know, they become more cost-driven as opposed to value or quality-driven.
I see.
You can get rapid interchange and greater price sensitivity. So the challenge over in Part B, Umer, is to offer a very well-rounded value proposition of wraparound, wraparound services, high-quality product, all the things you need to maintain a stronger price. What you see us doing here, for example, with UDENYCA and CIMERLI, is exactly that.
Right.
We're the only product that had, for example, both dosage forms, all indications, interchangeability out of the gate. We have now surpassed 150,000 injections with Cimerli, Lucentis. And that's, that's really important because, as you know, these ophthalmologists have been burned before by new products that come on the market. You know, they start hitting 10,000, 20,000, 30,000 patients after six months, and then they're yanked from the market. There's adverse events, you know, safety concerns that develop. So the fact that we've gotten CIMERLI this far with 150,000 injections, and we have the endorsement of the KOLs and the physicians, and we have the confidence of the market, you know, bodes very well.
Got it. Got it. Got it. But does that mean not a lot of hope for Part D?
Part D on the biosimilar side, I think is very tough.
Even next year, HUMIRA wouldn't?
Yeah, I think next year is tough.
Really?
I think for Part D, for YUSIMRY, and for all these biosimilars, you know, Amgen's included, I think you're going to see very shallow increases. But I think the inflection point will come in 2025 on the back of, you know, the Inflation Reduction Act and some fundamental changes.
Got it. Okay, I want to start to sort of go beyond this, and I know there's obvious and important topics to discuss. Let me talk about the toripalimab approval for your PD-1. And, my question specifically is, for a lot of folks, they think current PD-1s are approved everywhere, so there's always, there's always questions on what the next PD-1 and where they fit in. Can you remind us who's actually approved for that indication right now?
No one. We are approved. Go ahead, Doctor.
It's the first approval in the United States. Even chemotherapy isn't approved. So the label is broad, it's the first approval, and that's why the FDA also press released the approval. And it has all lines of therapy and all patient subsets. So it's, it's a very exciting opportunity.
What's the target market there? Number of patients.
Yeah, we estimate that there's about 2,000-2,500 drug-treatable NPC patients diagnosed annually.
25,000 ?
2500.
2500.
Yeah.
Okay.
Yeah.
Got it. And the label allows you to go first line?
It's first line and second line and greater. So first line in combination with chemotherapy, where the survival advantage is years. It's a two-year treatment in the first line. And the PFS went from 8 months with chemotherapy to 22 months with toripalimab plus chemo.
Do you expect at least 2.5 years of median duration commercially? Is that reasonable?
We expect the full label of two years, whether physicians will treat beyond that time, if a patient's doing well, we'll have to see. In the second line and greater as monotherapy, the treatment is till progression, so it's continuous.
Got it. And the annual pricing on this is?
Paul?
Yeah, we priced it at $8,892 per single-dose vial. That's within the range of the pricing of existing PD-1s.
So it's $16K per month?
Well, for a cost of treatment, annually, about $153,000, assuming an every three-week dosing cycle, which is consistent with the first line.
Got it.
Yeah, excuse me, Umer. So our focus on the pricing, really, and we looked at this very carefully and researched it carefully. We didn't want there to be any impediments to adoption whatsoever, right? So we're priced, you know, slightly under Keytruda, you know, but we wanted to make sure that we had, you know, the label, the full press, you know, coverage, you know, the promotion, but also, you know, a strong enough price where there wasn't any excuses to write the script for LOQTORZI. Because our view is that we go in, take this market, ramp the market up as quickly as possible, just maintain this market out.
Got it. In terms of, like, if I run rough math on it, 2,500 newly diagnosed patients a year, I don't know, 60%-70% penetration, couple of years duration. Even at a couple of years duration, this is over a $500 million product. Is that consistent with some of the estimates out there?
Estimates may vary. I think our words are around $200 million a year, and I think you'll have normal sort of price increases. We'll probably hit that peak in-
Well, I guess, why wouldn't it be meaningfully north if it's the only one? 'Cause it sounds like you're implying more like a 25-30% penetration.
No, no, no. I think, I think we'll get very, very strong pre-penetration. I think it's a question of duration of treatment, which line of therapy you intercepted the patient at. But we'll be happy to send you a model, a little more refined on the revenues, if you like.
Yeah, in the first year or so, we're gonna be picking up patients, you know. So in their second, third line, they're gonna be heavily pre-treated.
Right.
If they're on chemo only, you're gonna add LOQTORZI. Even with that, we hope to extend or, you know, you know, progression-free survival, which we, we aim to do. But, you know, the duration's gonna be shorter. So as the market unfolds over time, and those second-line, third-line start to decrease because now we're being used in the first-line setting. Follow me?
Got it.
You know, it's waiting. You know, with these rare diseases, you've gotta wait a little bit longer for the full maturation of the full patient base to unfold. But we expect, you know, high market share at peak in the next 2-3 years.
Got it.
Yeah.
Finally, and I know we're at time, but I do wanna mention, 'cause it's important, IL-27, how are you thinking about positioning as well as emerging data? Because I don't think this is a target that's been, that's been, that There's a lot of development.
It's underappreciated.
That's 'cause we're first in class. Go ahead, Theresa.
The idea of modulating a cytokine is well understood to rebalance the immune system in inflammatory diseases, hasn't been successful in oncology. I, I think with IL-27, there's a lot of attributes that really pre-clinically indicated it was a heavy immune suppressive cytokine in the tumor microenvironment. Importantly, in clinical trials, we've seen activation of the immune system, T-cells, NK-cells, monotherapy responses in non-small cell lung cancer, PD-1 experienced, PD-L1 low, two patients, and RCC. So, and then good combination with atezo bev, pembro. We're now doing it with toripalimab, obviously. We're presenting next week at ESMO IO, the data in non-small cell lung cancer. So I think adding toripalimab to IL-27 in a second-line PD-1 refractory non-small cell lung cancer is a very exciting opportunity, looking at earlier lines of therapy. The HCC data we'll present early next year.
Got it. Do you expect monotherapy responses?
So I would have bet money there wouldn't have been. There is. The issue is, it's not adequate enough to develop without p atient selection
Right . It's not a 20%? Okay.
So 2 patients out of 40 in the non-small cell lung cancer cohort, 2 of 9 squamous, starts to get more interesting.
Got it. When is the first randomized data set for your IL-27 we can get?
Well, the data set in 2024, we'll be looking at combination with Tori, to then establish enough efficacy to then go into randomize.
Excellent. Thank you, guys. Thanks for making time.
Thank you, Umer.
Thanks very much.
Very helpful. Good luck.
Thank you, sir.