McDavid Stilwell, Chief Financial Officer of Coherus BioSciences. We issued a press release earlier announcing the U.S. FDA approval of LOQTORZI for the treatment of nasopharyngeal carcinoma. This release can be found on the Coherus BioSciences website. Today's call includes forward-looking statements regarding Coherus' current expectations about future events. These statements include, but are not limited to, our ability to enter into future partnerships, gain approval for new products, and to launch our products in a timely manner. Projections of future financial performance, including expenses and revenue, projections of future market share for any product, and our expectations for market opportunity for any indication. All of these forward-looking statements involve substantial risks and uncertainties that are beyond our control and could cause actual results, performance, or achievements to differ from those implied by the forward-looking statements.
These statements are not guarantees of future performance and are subject to substantial risks and uncertainties, including risks and uncertainties that are discussed in our press release that we issued today, as well as the documents that we file with the SEC. Forward-looking statements provided on the call today are made as of this date, and we do not undertake, we undertake no duty to update or revise any forward-looking statements. With me on today's call are Denny Lanfear, CEO of Coherus, Dr. Theresa LaVallee, Chief Development Officer, Dr. Rosh Dias, Chief Medical Officer, and Paul Reider, Chief Commercial Officer. I will now turn the call to Denny.
Thank you, McDavid. Thank you all for joining us this afternoon. Sorry for the technical delay. The LOQTORZI approval is a seminal event, establishing Coherus as an innovative immuno-oncology company, and LOQTORZI is the cornerstone of our strategy to use next-generation therapeutics to extend cancer patient survival. We plan to develop LOQTORZI in combination with other novel IO agents that target the tumor microenvironment, including the pipeline programs Coherus acquired through its recently completed merger with Surface Oncology. Coherus is now one of a small handful of companies in the U.S. with an approved PD-1 inhibitor. We've received numerous inbound inquiries regarding partnering opportunities for LOQTORZI combination development, and we are now well-positioned to become an immuno-oncology partner of choice.
I want to congratulate our team on the approval, and I want to thank my partner, Junshi, who provided us with a molecule with robust efficacy and strong safety across indications. Theresa LaVallee, our Chief Development Officer, will now speak to the regulatory approval and the unique attributes of LOQTORZI. Theresa?
Thanks, Denny. We are thrilled to have LOQTORZI approved by the U.S. FDA for the treatment of all lines of therapy and all subgroups of patients with nasopharyngeal carcinoma, or NPC. This is the first drug approved in the U.S. for NPC patients and is based on a clinically meaningful and statistically significant survival benefit reported in the JUPITER-02 and POLARIS-02 study. We are grateful to the FDA and thank them for prioritizing the BLA-required inspection and taking a final action within less than a month of completing the clinical inspection, making this treatment option available to these underserved patients with a high unmet medical need. LOQTORZI is a next-generation programmed death receptor-1, PD-1 monoclonal antibody that blocks PD-1 ligands, PD-L1 and PD-L2, with high potency at a unique site on the PD-1 receptor.
With this approval in hand, LOQTORZI in this key indication allows us to focus on our next stage of our IO strategy, developing LOQTORZI with casdozokitug, our IL-27 antibody, and CHS-114, our cytolytic CCR8 antibody, which have demonstrated promising clinical data, and we will have updates over the next 18 months. As Denny indicated, we plan to pursue partnerships for co-development with novel agents such as T-cell engagers, bispecifics, and ADCs. Now, Dr. Rosh Dias, our Chief Medical Officer, will share with you more about LOQTORZI's clinical profile. Rosh?
Thanks, Theresa. We are delighted to bring LOQTORZI to patients in the U.S. living with nasopharyngeal carcinoma as the first and only FDA-approved treatment for NPC patients across all lines of therapy. We'd first of all like to thank both the investigators and patients who participated in the JUPITER-02 and POLARIS-02 clinical studies, upon which this approval was based. NPC is a type of head and neck cancer that, due to its anatomical location behind the nasal cavity and just below the base of the brain, is rarely amenable to surgery and has limited therapeutic options. Currently, the majority of patients are treated with decades-old chemotherapy, primarily gemcitabine and cisplatin. LOQTORZI approval in both first-line patients with metastatic or recurrent locally advanced disease in combination with cisplatin and gemcitabine, and also as a single agent for patients with resectable...
with recurrent unresectable or metastatic disease progression after platinum-containing chemotherapy, marks a step change in the standards of care for NPC treatment. The approval is based on strong efficacy data from two well-conducted studies and a safety profile consistent with class. Data published in Nature Medicine and presented at both AACR and ASCO.
Firstly, in JUPITER-02, LOQTORZI in combination with chemotherapy in first-line patients with either primary metastatic or recurrent disease showed a hazard ratio of 0.52 for progression-free survival and of 0.63 for overall survival, with benefit seen across all PD-L1 expression levels. The results were both statistically significant as well as clinically meaningful. Secondly, in POLARIS-02, in second line and beyond, single agent LOQTORZI met its primary endpoint of overall response rate with an OR of 20.5% and also demonstrated a median overall survival of 17.4 months. The adverse event profile in both trials demonstrated an acceptable safety profile, which is consistent with drug class. This represents a landmark approval for NPC that now offers patients an approved therapy for the treatment of their disease, and we really look forward to bringing LOQTORZI to patients in the U.S.
Paul Reider, our Chief Commercial Officer, will now discuss our commercial plans for the upcoming launch. Paul?
Thank you, Rosh. Good afternoon, everyone. The Coherus commercial team is very excited to finally bring to patients and providers the first and only FDA-approved treatment for patients diagnosed with relapsed or metastatic NPC. We estimate that approximately 2,000 NPC patients are diagnosed each year, and we'll be able to access all of them, as our broad indication allows for LOQTORZI to be used in combination with chemotherapy in all lines of therapy, including first line. We believe that LOQTORZI opportunity in NPC is large, with an estimated value at peak of up to $200 million. Through NPCfacts.com, we've now enrolled a community of over 2,100 NPC patients or caregivers and will appropriately communicate LOQTORZI branded information with them, so they are informed and educated in speaking with their doctors about their individual treatment plans.
Finally, LOQTORZI is being efficiently integrated into our existing oncology commercial infrastructure. The team is fully trained and launch activities will immediately commence. We expect the commercial launch in early Q1 2024. I look forward to updating you on the progress of the launch as it commences. I'll now hand the call back over to Denny.
Thank you, Paul. Thank you all for joining this afternoon. We're happy to take questions. Ready?
Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. One moment for questions. Our first question comes from Robyn Karnauskas with Truist Securities. You may proceed.
Hi. Thank you, and congrats, Denny and Theresa. I know hard work was at hand and for your team, so congratulations. I guess I have a couple. You talked about partnerships, and so my first question is about partnerships. How do you think about the timelines for doing those across the year? Because those could be catalysts for the company. And what are your goals and what you want to get out of the partnerships? Do you want them to spend more money and help you run the trials? Like, what are the goals? My second question is really about commercialization.
I don't know if you can comment on price yet. I know you're launching in 2024, but how are you thinking about, you know, the needs on the SG&A front to, I know you can have some leverage there, but talk to me a little bit about how we think about modeling, the expense side for launching this product? Thanks.
Thank you for your question, Robyn. First of all, I would say that we've had significant incoming interest from potential partners as we approach the approval. I think that there is an unmet need in the market for a highly efficacious and safe PD-1 for a variety of combination approaches. As Theresa pointed out, T-cell engagers, bispecific and so on. We would expect to begin to engage with those parties directly and have additional conversations at, for example, the healthcare investment conferences now in the fall and then, of course, in the first of the year. Our objective would be to complete a number of those by mid next year.
On that side of things, we believe putting toripalimab in the hands of our partners is a very, very good way to enhance patient benefit and advance our key objective, which is to extend patient survival in a number of these cancers with unmet needs, like you've seen in NPC. With respect to commercialization and potential pricing, I'll let Paul address that question for you. Paul?
Thanks, Denny. Hi, Robyn. Thanks for your question. Yeah, so, in terms of commercialization, LOQTORZI is gonna be, integrated into our existing oncology commercial team and infrastructure. So no new additional headcount required. Team's fully trained and ready to go. We are gonna be sharing more about price as the launch progresses. But what's gonna happen between now and when we expect, full launch in early Q1, we'll be establishing, you know, the payer coverage, educating the customers, you know, getting our hub stood up for LOQTORZI Solutions. And, you know, our goal is to ensure that we can get patients this treatment as fast as we can.... I would,
thanks, Paul. Robyn, with respect to your question about modeling, we would anticipate, probably a two to three-year period to reach, maximal market penetration.
And Paul's team has done an excellent job of identifying these patients with NPCfacts.com. So we're going to be, I think, very active in terms of educating the patients and so on. A number of these patients are on existing therapies, but as more patients are diagnosed, our objective is to bring them all on LOQTORZI from day one. So probably that period of time is a, is a, appropriate way to model the ramp.
That's helpful. Just one follow-up there. So when we're thinking about, like, how you're gonna talk about LOQTORZI in the next, you know, six months or so before you launch, when do you plan to give an update on more solid guidance on the sp- the spend? I mean, a three-year ramp is pretty fast. So market research, updated market research, do you plan to give that to JP Morgan? Could be a little bit like a call in early first quarter. Like, what are your thoughts there? And that's my last question. I'll let other people get back in the queue.
Sure. We thank you for that. We probably won't say too much about that on our upcoming quarterly call, but you can certainly expect that by the time of the Q4 call, which will happen in the February, March timeframe.
That being said, I would, I would point out that we have been very active digitally in identifying these patients, and so we probably will have spends which do not approach that of traditional launches. Secondarily, commercialization is highly synergistic with our existing UDENYCA franchise, and so the call points, I think, have like a 95% overlap. And so we do not anticipate having extensive additional costs associated with the launch, although, of course, there will be certain marketing and educational costs. Happy to provide an update for you.
Thank you, guys, and congrats. It's good news on a Friday night, and I'm dressed like a, in a Halloween costume, so it's like, you know, congratulations.
Thank you, Robyn.
Thank you. One moment for questions. Our next question comes from Yigal Nochomovitz with Citi. You may proceed.
Hi, team. This is Ashiq Mubarack on the call. Very big congrats on the approval and really great to see how you navigated this whole entire regulatory saga. Just a few questions from me. I guess first, what has to happen before you can launch the drugs in the first quarter? And it sounds like it will be a really early first, first quarter launch. So what, what do you anticipate you need to do between now and then before you can start to generate some revenue? Thanks.
All right. Thanks for your question. Paul can comment a little further, but, you know, post-approval, you have to, you have to finish printing the package insert. You know, you, you have to import. You cannot import until you are approved. Then you have to label, box up, ship to 3PL. Typically, this sort of exercise takes between 8 and 12 weeks. If you look at our previous, launches, so we may anticipate this happening in about that same period of time. But there's just a few things that you cannot do, until you are approved, such as import, finish labeling, and so on. And of course, you don't know what the final label says until you're approved either. However, we are pleased that the FDA acted so promptly on our application after the final inspection.
I think there was just tremendous impediments for them to overcome, get the inspections done in China, and get back and forth. So we want to just, you know, thank them for helping us as we move forward to get to these patients.
Okay. Okay, got it. Maybe I have a last couple follow-ups. I guess on the patient identification front, I know you mentioned the 2,100 number, but I'm wondering if you can split that between how many are patients versus caregivers. And it sounds like we should expect this launch to sort of reflect maybe a bolus effect. Do you think that's fair? And when do you think we can sort of start to see the payer coverage come online?
Paul, would you like to address those issues?
Yeah, sure. The split's about 60/40 between patients and caregivers in the enrollment of our NPCfacts.com. So, that's the split, and we'll be able to now, with approval, engage with them with more approved promotional LOQTORZI branded information so that they're fully educated when they go and speak with their physician about their treatment. You know, if the patient is getting chemotherapy today, just, we have approval on all lines of therapy, you know, the doctor can simply add LOQTORZI to their current chemotherapy regimen. That's fully indicated. And so, you know, that's gonna be the primary, you know, approach with the patient engagements. Secondly, as it relates to, you know, payer coverage, that should, you know, vary, but you would expect, you know, coverage to come online usually within 30-60 days.
However, because this is a rare disease, we go through treatment. Doctors can submit, you know, patient prior authorizations, and given the data, we don't expect, you know, much in the way of payments are going to go.
With respect to your question about the shape of the adoption curve, we'll have a little more to say about that on our earnings call, but Paul may wish to comment further, but I believe there's been a number of patients and physicians, KOLs, even today, reaching out for the availability of product. Paul?
Yeah, that's right, Denny. You know, we spent the last couple of years, you know, as we've been waiting approval, engaging and nurturing the KOL relationships in head and neck and NPC. So when they heard the news today, they've already reached out to us, very excited, want to know exactly when their pharmacists can have it in their clinic. So, that's a very exciting event and goes to the high unmet need and demand for LOQTORZI for these patients.
I would just, and Rosh may comment further, but I would just underline that, you know, there is no approved treatment for these patients.
Absolutely, Denny. Thank you. Currently, there are zero approved treatments. Current standard of care is, as I mentioned, decade-old chemotherapy, gemcitabine plus platinum. So I think this will be a very welcome add to the therapeutic options. In particular, this will be the only approved regimen in this disease. So I think all in all, very, very strong news for patients.
So we anticipate strong adoption.
Okay, got it. That's very clear. Last question from me. I understand that the NCCN guidelines already have the PD-1 recommended for use in NPC. I think some of that is all based on your data. I'm just wondering if you have a sense of how much off-label use is already occurring or if there's any clear data on that?
Well, yeah. I wouldn't say there's clear data, but, you know, when you look at claims data, which, you know, gives you a snapshot of the marketplace, we estimate that there could be about 40% of existing PD-1 use, you know, in the marketplace. So it's certainly not, you know, considered standard of care. But with our data, as you mentioned, being, you know, the only phase 3 trial, plus with both PFS and very significant overall survival data, we believe that we'll have the science to position LOQTORZI plus chemo as the new standard of care.
Rosh, yeah. Thanks. Paul, just tagging on to what you were saying, I'll just... For those of you who are at ASCO and heard the update and final overall survival analysis at ASCO this year, the discussant specifically said, at the, from the podium, "This is practice-changing data." So I think, again, given that we'll be the only approved regimen now in, in, NPC, again, I support what Paul is saying.
Got it. Congrats again.
Thank you.
Thank you.
Thank you. One moment for questions. Our next question comes from Michael Nedelcovych with TD Cowen. You may proceed.
Thanks for the question. I'm curious, in your labeling discussions with the FDA, is there anything that has surprised you, either positively or negatively, in the label? And as regards to NCCN guidelines, what are the steps you need to take now to get LOQTORZI listed in those guidelines, and what is the timeline? So would we expect that update to come by Q1 launch, or might it take longer than that?
Thank you for that, Michael. I'll first have Dr. LaVallee address the issues of the label, and then Dr. Rosh our CMO can subsequently discuss the NCCN.
Yeah, thanks for the question. I'm happy to say lots of happy surprises or what I would call recognition of the data, in that getting a approval for all lines of therapy and all subgroups is, you know, as good as it gets. And having them recognize the strength of the data in both JUPITER-02 and POLARIS-02 to grant a full label is really tremendous. So I'll let Rosh talk about the NCCN.
Yeah, thanks for the question. So I think the NCCN submission process itself is fairly straightforward. I do think the data speaks for itself. So now that we are approved, we are able to submit, which we'll do shortly. It's hard to comment on exact timelines for progressing through the NCCN system because the meetings tend to be, you know, different depending on the different therapeutic areas that you're looking at. For NPC specifically, the submission will go in over the coming days, and so I anticipate, again, given the strength of the data and given the fact that we're the only approved therapy, this to be a fairly straightforward, hopefully, review.
Thanks, Michael.
Thanks, all.
Thank you. One moment for questions. Our next question comes from Douglas Tsao with H.C. Wainwright & Co. You may proceed.
Hi, good afternoon, and congrats on the approval. I guess my question is, now that you have toripalimab approved, does this change the velocity of business development in using it in combination with other agents and agents obviously that you don't own, obviously you acquired Surface, and those studies are ongoing, to broaden the use of Tori outside of NPC? Thank you.
Hi, Doug. Yes, I think that it's fair to say there's been significant interest on partnering with toripalimab prior to approval, and we'll certainly have accelerated conversations post-approval. Mechanistically, I think toripalimab really is an ideal combination partner for a number of these therapeutics, as you saw with the Surface Oncology acquisition and the products that we expect to pair with addressing tumor microenvironment. So, you know, to the question of velocity, yes, and further, I think there is significant interest ex-US in rights to the Surface Oncology assets that we can also have a clear view on now. We've also been approached by folks in other countries. So that was keeping in mind that casdozokitug, you know, 388 is a first-in-class molecule that we're moving forward with. Theresa, anything additional?
I mean, I think the thing that surprised me is, you know, it's Friday, and we sent the press release out, and we're all getting our inbox filled for both investigators and other people regarding partnerships. So next week is SITC, perfect timing. We have presentations there and meetings ongoing. So, thrilled to be out there with an approved drug.
Great. Again, congratulations.
Thank you, Doug.
Thank you. One moment for questions. Our next question comes from Ash Verma with UBS. You may proceed.
Hi. Congrats from my side, too. I know it's been a field battle, so good job on getting this done. I had a couple of questions. So just on pricing, I think that your partner, Junshi, has commented in the Chinese media websites that they expect this to be priced at one-third of KEYTRUDA. I know that you're going to share the specifics later, but can you at least, like, comment, would it be a brand like pricing, or are you more likely to follow a discounted pricing strategy here? So that's one. And then-
Yeah, I'm...
Yeah.
I'm sorry, Ash. I'm sorry. Just want to be clear.
Yeah.
Could you just restate your iteration of what our partner, Junshi, said about pricing?
Yeah, the, the pricing could be, one third of KEYTRUDA price.
Is that in China?
This is about the U.S. market.
Yeah, let me address that issue head on. We will not engage in that sort of pricing for this product in the U.S. Even if you look at our experience with UDENYCA, which was about similar, that product was positioned as a branded product. You know, this is a branded product, and this product has a very, very strong efficacy profile. It's a very unique indication, and so we will not definitively, I will tell you that we will not engage in heavily discounted pricing for this product.
All right. That's very helpful. Thanks for that. And then a couple of other, just around the patient population. I mean, based basically like some of the physicians that I've talked to, I think this patient population is fairly concentrated in some large metro areas. I, as you've done the mapping on this, I just wanted to understand, from the ease of accessing this patient population, is that a fair assumption to make that once you reach some of these large hospitals that might carry a bulk of these patients, this should be a fairly quick ramp in that geographical locations?
Well, would you like to address the issue of the, you know, the patient distribution with respect to population centers and our ability to reach patients?
Yeah, Ash, you're right. There's probably about 2,000 active prescribers of NPC, and you'll see concentration, you know, in metropolitan areas with large academic medical centers that, you know, treat, and do a lot of clinical research in head and neck. However, there's also, you know, a fair amount in the community as well. Through our claims data that we've been tracking over the last couple of years, we know where every one of these, you know, NPC treaters are. I'm very pleased to say that we have significant overlap with our current UDENYCA call points in each of these accounts, so it's a very efficient launch from a personnel standpoint. We have relationships with all those pharmacies, and that will go, that will go very smooth.
So, you know, we have tools in place that the team will also be employing with accounts to be able to, you know, find these patients as you would in any rare disease. So, we trained the team up last week actually, and they're ready to go. So, we're gonna be doing a lot of prep work between now and when we get drug and channel. So when, you know, that product's available, patients will be ready to receive their treatments.
Yeah. Yeah. Great. Excellent. Thank you so much, and good luck with the launch.
Thank you. We have time for one more question. Our last question comes from Balaji Prasad with Barclays. You may proceed.
Good afternoon. This is Shaun for Balaji. Thanks for taking our question, and congrats on the approval. Just following up on the BD, as you know, this approval in NPC will make all the subsequent approval, all the future indications approval, a subsequent approval. So do you think this event will accelerate the future BD activities in other indications? And also, you know, given that we are still waiting for the label, so could you add some color on the dosing schedule for NPC? Thank you.
Let me, let me first of all, let Dr. Dias,
...part of your question with respect to the dosing and the dosing schedule. Rosh?
Yeah, there are two indications in, in first line and second line and beyond. The first line indication is toripalimab in combination with gemci. Toripalimab dosed at 240 mg every three weeks. The second line plus indication is a single agent toripalimab 3 mg per kg. With respect to your-- and, and twice daily.
Thank you, Rosh. With respect to the first part of your question, in NPC, our overarching strategy for LOQTORZI is to develop it in combination with other agents, which are synergistic and surpass existing standard of care benefits. So you will not find us, for example, doing reference studies head-to-head with standard of care in order to establish non-inferiority, those types of studies. So there's a number of agents which are coming forward now, next generation agents, both the agents that we received as a result of the Surface Oncology merger, but other agents also, where people, as we indicated, were reaching out to us.
So we think that the way to advance Tori and to expand it to, immuno-oncology is in conjunction with these other therapies, thereby expanding, establishing superiority over standard of care approaches, which is, you know, checkpoint, single checkpoint team therapy. Is that helpful? Theresa, would you have something to add?
Yeah, so that, that's great. The one thing I would add is that LOQTORZI has several positive phase 3 studies, and so that data can be used to establish contribution of component. So it also will accelerate the ability to look at development with new combinations to advance treatments. So we're super excited and, and have a strong signal to move forward.
Thank you. Shaun.
Thank you. I'd now like to turn the call back over to Coherus BioSciences for any closing remarks.
Thank you. Thank you all for joining us today, and thank you all for your support as we proceeded with the approval of LOQTORZI over the past couple years. We will have updates for you on our earnings call in early November, and we'll also be seeing you at a couple of investor conferences in the first week of November. Thank you all very much.
Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
Good bye