Good day. Thank you for standing by. Welcome to the Coherus BioSciences Q1 2023 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will hear an automated message advising that your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your 1st speaker, Marek Ciszewski of Investor Relations for Coherus BioSciences. Please go ahead.
Thank you, Crystal, and good afternoon, everyone, and thank you for joining us. We issued a press release earlier today announcing our financial results for the 1st quarter of 2023. This release can be found on the Coherus BioSciences website and is also attached to our Form 8-K. 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 gain approval for multiple new products and launch them, the ability of the FDA to complete all required inspections in China for our BLA for toripalimab necessary for approval, expectations about demand, timing of our ability to gain market share for any of our approved products, expectations about future revenues and expenses, and the timing of any return to profitability.
All 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 forward-looking statements. These statements are not guarantees of future performance and are subject to substantial 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 undertake no duty to update or revise any forward-looking statements. First quarter 2023 results are not necessarily indicative of results for future periods. With me on today's call are Denny Lanfear, our CEO; Dr. Theresa LaVallee, Chief Development Officer; Dr. Rosh Dias, Chief Medical Officer; Paul Reider, Chief Commercial Officer; and McDavid Stilwell, Chief Financial Officer. I will now turn the call over to Denny.
Well, thank you, Marek, thank you all for joining us on our Q1 2023 call. In Q1, we set the stage for revenue growth over the rest of the year as we plan for and execute multiple product launches across our diversified pipelines throughout 2023, transitioning from a single product company, one with six products or presentations, including our 1st immuno-oncology agent, toripalimab. This quarter, we executed strongly on the launches and growth catalysts in support of emerging pipeline. The progress includes, 1st, the Q code for CIMERLI, which was implemented at the beginning of April. Demand is now increasing as expected. UDENYCA auto-injector is now ready for launch later this month, key driver for market share increase this year. We're ready to launch YUSIMRY, our Humira biosimilar, in July, having gained all the requisite approvals to build inventory.
Manufacturing facility inspection to support toripalimab approval is now scheduled for later this month, May. We expect the approval and launch of the UDENYCA on-body injector later in 2023, strengthening the franchise positioning and driving additional share gains. Following my opening remarks, Paul Reider, our Chief Commercial Officer, will update you on the impact of the CMS assigned Q code on CIMERLI sales at the start of the 2nd quarter, which we expect to drive sales starting in Q2 and accelerate revenue growth throughout 2023. I will then further update you on the Q1 2023 UDENYCA sales and our launch plans for our newly approved UDENYCA auto-injector. Dr. Theresa LaVallee, our Chief Development Officer, will update you on the status of the toripalimab inspections, the BLA review, and our progress on bringing Tori manufacturing to the U.S., along with other pipeline developments.
Chief Medical Officer, Dr. Rosh Dias will then update on the new toripalimab clinical data being presented at ASCO, as well as progress on our TIGIT toripalimab combination studies and our ILT4 program. As you know, we've been very tightly focused on actively managing expenses without jeopardizing our product sales potential. McDavid Stilwell, our Chief Financial Officer, will provide you some additional detail on measures taken during Q1 to reduce operating expenses, sharpen our focus on ensuring the success of our product launches, key revenue drivers that we anticipate will return the company to profitability in 2024. With that, I'll turn the call over to Paul Reider, our Chief Commercial Officer. Paul.
Thank you, Denny. Good afternoon. I'll provide you with an update this afternoon on the expansion of our commercial product portfolio. The potential launches of 4 products in 2023 we expect will drive top-line revenue growth this year and going forward. I'll start with CIMERLI, a fully interchangeable Lucentis biosimilar launched in the 4th quarter last year. Our strategic approach to the market is to 1st maximize the conversion of existing Lucentis business, which currently represents 1 billion units annually, and 2nd, grow share through new patient starts or conversion from other anti-VEGF products.
While the complete label with interchangeability has been well received by retinal specialists, giving them the confidence that they can safely transition currently treated Lucentis patients to CIMERLI, expect the same clinical outcomes. Use of the miscellaneous J code has hindered adoption and conversion. Billing under a miscellaneous code is prone to errors, interrupting payment flows. Even if executed correctly, can result in payment delays of two months or more, which disrupts practice cash flows. We expect a slower start to CIMERLI sales until the activation by CMS of our permanent product-specific Q code, which enables electronic automated billing, thus providing faster payments with much higher certainty. Accordingly, we focused our efforts in Q1 on obtaining the permanent Q code from CMS and getting it deployed across ophthalmology practices and payers. Those efforts are bearing fruit.
The payer front, as of April 30th, over 90% of target payers have confirmed loading the Q code. With respect to billing and reimbursement using the Q code, numerous providers have reported receiving full reimbursement within 14 days of electronic billing. We are now seeing the expected increase in demand. Through the month of April, we've shipped over 7,200 demand units, which represents about 72% of the entire Q1 2023 unit sales. During Q1, we doubled the number of accounts that have ordered CIMERLI to 185, and of those 54% have reordered. Among these ordering accounts, CIMERLI market share was 20%, which reinforces the potential of CIMERLI once accounts begin adopting.
Momentum built in Q1 prior to deploying the Q code, doctors are reporting that they are seeing the same clinical outcomes with CIMERLI they would expect to see with Lucentis. CIMERLI is successfully establishing an excellent safety and efficacy track record with retinal specialists. This helped fuel the doubling of demand in Q1, resulting in an average ranibizumab market share for the quarter of 4.1%, compared to 2.4% in the prior quarter. At the same time, inventory levels on hand were higher at year-end, given Q4 was the launch quarter, but have begun to normalize. For the 1st quarter, sales of CIMERLI were $6.2 million, compared to $6.95 million for Q4. Reordering reflects new patient starts and conversion from other products.
With the chronic nature of the disease and frequency of injections, this results in a compounding growth trajectory. We continue to expect that in 2023, CIMERLI revenues will exceed $100 million. I'll now turn to our oncology franchise, starting with UDENYCA and the launch plans for the two new presentations this year. As you know, the pegfilgrastim prefilled syringe segment is increasingly competitive, as reflected by continued price erosion. Our strategy is not to compete solely on price, but to launch additional presentations that provide a differentiated value proposition to patients and providers, filling unmet needs in the market with the objective to regain share. The past year, we told you that we would sacrifice share to preserve pricing power for these future presentation launches.
As all product presentations are linked to the same average selling price, can we maintain a strong ASP on which to launch our two new innovative presentations this year? We plan to launch UDENYCA auto-injector later this month. This presentation represents the 1st innovation in the pegfilgrastim class in 8 years. The customer receptivity has been overwhelmingly positive. This confirms that there is a large market segment unserved by Neulasta Onpro, the on-body device, which still retains 43% of the market. UDENYCA auto-injector provides convenience, administration flexibility, independence, and certain delivery in under 10 sec. The auto-injector thus provides providers and patients a highly desired alternative to Onpro and has the potential to drive market share increase over the coming quarters. Q1 2023 was our last quarter competing with one undifferentiated presentation.
UDENYCA net sales were $26 billion, declined from the prior quarter, resulting from four key factors. First, a market share decline of 1% from the prior quarter to 11.5%. A 9% decline in net selling price required to maintain a competitive position in prefilled syringe segment. Higher wholesale inventory levels at the end of Q4, which have now normalized. Finally, a non-recurring $1.7 million charge resulting from a contingent liability arising from a dispute. Going forward, we believe the UDENYCA franchise is well-positioned to regain market share beginning the 2nd half of 2023. UDENYCA is now the only pegfilgrastim brand with both prefilled syringe and autoinjector presentations. Later this year, with the on-body injector, if approved, we will be the only pegfilgrastim brand with all three product presentations.
This will provide a path for maximum market penetration and market share growth this year and beyond. We expect our next oncology launch to be toripalimab, if approved. Let me cover some of our launch plans. Launching the company's 1st immuno-oncology product is a critical step forward in the advancement of our bio franchise. Our mission is to extend cancer patient survival and to offer new hope to patients. Nasopharyngeal carcinoma is an excellent example. Today, NPC patients have no FDA-approved treatments, including biotherapies, and therefore constitutes a high unmet need. Toripalimab is a next-generation PD-1 inhibitor, and if approved, will be the 1st and only PD-1 inhibitor in the U.S. indicated for relapsed metastatic nasopharyngeal carcinoma, establishing a new standard of care in all lines of therapy, including 1st line.
We feel confident that toripalimab plus chemo will gain a dominant market share and estimate the NPC market opportunity could reach $200 million at peak. Preparation for toripalimab's commercial launch, we are executing on a number of pre-launch activities. We created and launched NPCfacts.com, which is designed to be a primary source of disease state information for patients and their caregivers to learn about NPC. A sister site for healthcare professionals was also launched. NPCfacts.com allows patients and their caregivers to join our community, enabling us to share disease state education that is tailored to each patient at each stage of NPC disease progression. Our aspiration is to identify and appropriately engage with all NPC patients in the U.S. by the end of the year.
We continue to train our oncology sales force so they will be ready at launch to educate doctors on toripalimab's differentiated mechanism of action and the impressive patient survival benefit demonstrated at NPC, irrespective of PD-L1 expression status. We will launch a peer-to-peer educational program featuring the nation's leading opinion leaders in the field of head and neck cancers and NPC, and we look forward to engaging with these KOLs at the upcoming ASCO. While some modest marketing investment will be required to identify patients and educate physicians and providers on the benefits of toripalimab, our oncology commercial capabilities were built to scale with significant overlap between UDENYCA customers and toripalimab targeted prescribers. The launch of toripalimab is being efficiently integrated into our existing oncology commercial infrastructure.
We are ready to launch toripalimab upon approval and expect to successfully address the entire NPC patient population across all lines of therapy and irrespective of PD-L1 expression status. I'll end with Yusimry, our Humira biosimilar, which is on track to launch in July. Market feedback confirms that price, robust supply, and product presentation are the key criteria used in making formulary decisions, and Yusimry is well positioned to compete on each of these criteria. Yusimry will have a state-of-the-art auto-injector presentation. It includes our proprietary non-stinging citrate-free formulation and a 29 gauge needle for maximal patient comfort. We will have substantial supply volumes at launch, with hundreds of thousands of Yusimry units ready for distribution in July. We are confident in our ability and our commercial approach, and we look forward to updating you in more detail on our strategy on our August call after we launch.
In summary, we are now at the inflection point of our growth story. 5 ongoing and new product launches will drive top-line revenue over the next 3 years. I'll now turn the call over to Theresa LaVallee. Theresa?
Thank you, Paul, and good afternoon, everyone. Let me begin with an update on our toripalimab inspections and projected approval. As you know, due to COVID travel restrictions in China, the PDUFA date was missed for toripalimab NPC application in December 2022. In January, the travel restrictions related to the COVID-19 pandemic were eliminated, and the inspection is now scheduled for the 2nd half of this month, May. We wish to thank our partner, Junshi Biosciences, for their thorough and diligent preparation efforts to make the inspection a success. With respect to the sufficiency of the clinical data to support the NPC BLA, we note again that the FDA granted toripalimab Breakthrough Therapy designation as there are no approved treatments for NPC. The agency has consistently recognized this unmet need and stated NPC warrants regulatory flexibility. The review of the BLA is now substantially complete.
The FDA conducted an extensive remote regulatory clinical assessment and did not identify any deficiencies. We continue to work with FDA to complete the clinical site inspection. Toripalimab is a next-generation PD-1 with a differentiated mechanism of action and has demonstrated an impressive survival benefit in multiple tumor types in combination with chemotherapy, irrespective of PD-L1 status. Based on these observations, we conducted mechanistic studies to better understand the basis of this differentiation. We have just completed preclinical studies for journal submissions demonstrating that toripalimab has higher potency on T-cell activation compared to pembrolizumab. These data further support the evolving understanding in the field that PD-1 antibodies are not all the same or necessarily equivalent. We plan to present our findings at a scientific meeting later this year.
We believe that this makes toripalimab an ideal foundation for our IO pipeline, as well as a combination agent for non-Coherus novel compounds. We are actively seeking additional development opportunities to expand toripalimab's use beyond NPC with combinations, as Dr. Dias will describe. I'm also pleased to report that Coherus' regulatory and manufacturing teams continue to execute at a very high level. In the 1st quarter, we gained approval for the YUSIMRY auto-injector, as well as the facility change for large-scale manufacturing. Additional approvals included the UDENYCA auto-injector presentation, the fourth approval of the quarter. UDENYCA's BLA supplement for the on-body injector presentation is progressing well, and we look forward to approval this year. Lastly, regarding tech transfer of the toripalimab manufacturing to the United States, I can report that we recently successfully completed the large-scale engineering runs needed to onshore manufacturing supply.
We plan to execute the process qualification lots this fall and have prioritized these efforts. I'll now turn it over to Dr. Rosh Dias, our Chief Medical Officer, for a clinical update on the Coherus IO pipeline. Rosh?
Thanks very much, Theresa, and good afternoon, everyone. Toripalimab continues to form the backbone of our immuno-oncology franchise. We believe that the publication of pivotal data across nasopharyngeal carcinoma, non-small cell lung cancer, and esophageal squamous cell carcinoma in top-tier journals, continuing positive data sets being released across multiple tumor types, together with its differentiated mechanism of action, will position toripalimab effectively as a partner of choice for combinations. Several toripalimab data sets across multiple tumor types and tumor settings have been accepted for presentation at the upcoming ASCO 2023 annual meeting. These include data in non-small cell lung cancer with final overall survival and biomarker analyses from CHOICE-01, 1st-line non-small cell study, as well as event-free survival data from NEOTORCH in the perioperative treatment of stage 2-3 non-small cell lung cancer being presented.
In metastatic or recurrent triple-negative breast cancer, PFS data will be presented from the TORCHLIGHT study. We will also be presenting the final overall survival analysis of JUPITER-02, the registration study in the 1st-line treatment for recurrent or metastatic NPC on Monday, June 5th, which shows clinically and statistically significant results. This will build upon the positive progression-free survival data presented in Nature Medicine in 2021 and at the 2021 ASCO plenary session, and which forms the basis of our BLA submission in NPC. With respect to our internal pipeline, we remain excited about our phase II/II-A toripalimab TIGIT study, which is currently active in the U.S., with anticipated results next year. In addition, our ILT4 asset remains on track as we proceed towards IND submission towards the end of this year. I'll now turn it over to McDavid Stillwell, our Chief Financial Officer. McDavid.
Thank you, Rosh. Today, we reiterate our prior financial guidance for 2023. We project revenue growth from accelerating CIMERLI sales and with the launches this year of toripalimab, YUSIMRY, and the UDENYCA auto-injector and on-body injector. For the full year, we expect to book at least $275 million in net sales, with at least $100 million of CIMERLI net product revenue. In the 1st quarter, we took measures to reduce operating expenses with a reduction in force and the rescoping of the toripalimab joint development plan. Along with other measures we implemented last year, we have significantly reduced expected 2023 R&D and SG&A expenses to a range of $315 million-$335 million. This range excludes non-recurring milestones and upfront payments, and it includes approximately $50 million in non-cash stock compensation expense.
Near the start of the year, we requested and obtained a waiver for the revenue covenant of our term loan through the 1st two quarters of 2023, recognizing that the CIMERLI Q-code would not be available until April 1st and that the UDENYCA auto-injector would not launch until May. For my review today of 1st quarter financial results, I'll touch on just a few highlights, as the details are in the press release 8-K and 10-Q we filed this afternoon. Net loss for the 1st quarter of 2023 was $75.7 million, or $0.96 per share on a diluted basis, compared to a net loss of $96.1 million, or $1.24 per share on a diluted basis for the same period in 2022.
We incurred approximately $4.9 million to non-recurring charges in connection with restructuring in March 2023. Net revenue for the 1st quarter 2023 was $32.4 million and included $26.2 million of net sales of UDENYCA. $6.2 million net sales of CIMERLI. Net sales of UDENYCA were reduced by a $1.7 million charge for a contingent liability related to resolving a dispute. Net revenue declined compared to the same quarter 1 year ago, primarily due to a decrease in the number of units of UDENYCA sold, as well as a lower net realized price. Cost of goods sold was $16.9 million during the 1st quarter of 2023.
Recall that UDENYCA COGS includes a mid-single-digit royalty on net sales payable through the 1st half of 2024, and CIMERLI COGS includes a low to mid 50% royalty on gross profits. COGS in the 1st quarter of 2023 included two non-recurring items: a $3 million contract modification fee with one of our manufacturers and a $2.7 million write-off of inventory that was damaged during processing at one of our manufacturers. Research and development expense for the 1st quarter of 2023 was $34.2 million, significantly lower than the year ago quarter when we reported $47.9 million in R&D expenses after excluding a $35 million license fee paid to Junshi Biosciences for the TIGIT antibody, JS006.
R&D expense for the 1st quarter of 2023 included $3.6 million in costs associated with the recent reduction in force. Selling, general, and administrative expense for the 1st quarter of 2023 was $49.2 million, roughly equivalent to the $48.8 million in SG&A expenses for the same period in 2022. SG&A expenses are primarily driven by commercialization activities to support current UDENYCA and CIMERLI sales and costs incurred in preparation for multiple anticipated new product launches in 2023. SG&A expense for the 1st quarter of 2023 included $1.3 million in costs associated with the recent reduction in force. Cash, cash equivalents, and investments in marketable securities were $128.1 billion as of March 31, 2023, compared to $191.7 billion at year-end.
Cash burn was elevated in the 1st quarter of 2023 by headcount-related costs specific to the quarter and was further impacted by introductory payment terms for the CIMERLI launch, which delayed cash receipts for product sales. We expect the timing of cash receipts to normalize in the 2nd half of the year. In 2023, we are focused on ensuring the success of our new product launches and generation of the anticipated revenue growth. We will continue to maintain tight control over our operating expenses as we aim toward a potential return to profitability in 2024. I'll turn the call back to Denny.
Thank you, McDavid, and thank you all for joining us on our Q1 2023 earnings call. Now that the CIMERLI Q code is active and we're beginning to see the impact of the 2nd quarter, we look forward to accelerating CIMERLI sales throughout the year. On the UDENYCA front, a launch later this month of a new innovative product presentation, UDENYCA autoinjector, will provide patients and physicians with a unique option to differentiate UDENYCA in the pegfilgrastim market, driving share gains. Development of our immuno-oncology franchise is progressing well. toripalimab, our foundational asset and anchor, continues in study after study to demonstrate strong efficacy and safety across multiple tumor types. For the next generation of PD-1, it positions Coherus ideally as the partner of choice for those developing combination treatments with their own proprietary agents in a number of cancers.
With the manufacturing inspection scheduled this month, we're optimistic that approval in the 1st indication, nasopharyngeal cancer, will occur in Q3. Lastly, through thoughtful and disciplined cost and expense control, we've significantly reduced our 2023 expenses by about $100 million to about $325 million. We'll continue to look for more efficiencies and savings as we progress our efforts to drive revenue increases while controlling expenditures to achieve profitability in 2024. Operator, we are ready for the questions.
Thank you. At this time, we will conduct a question-and-answer session. As a reminder, to ask a question, you will need to 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. Please stand by while we compile the Q&A roster. Our 1st question comes from the line of Robyn Karnauskas of Truist Securities. Your line is now open.
Hi, thanks for the question, and congrats on getting the manufacturing inspection set. That's great news. I have two sets of questions. I'll be really brief. On TORI, it seems like there was a press release by your partner, Junshi, around small cell lung cancer, which has typically been very difficult to treat with checkpoint inhibitors given it's a cold tumor. I had a few questions on that. What are your thoughts on, like, why TORI worked, you know, given is it the differentiated epitope and MOA that you think is driving the response? How does this change your overall strategy with TORI? You talked about partnering going forward. It seems like this would be a pretty big deal if it works in SCLC. Talk a little bit about how much collaboration interest there is and how, where people are at this new data set. I have one on UDENYCA.
Thank you, Robyn, for that question. Yeah, we were very pleased to see the small cell data announcement this morning. I'll let Dr. LaVallee address the issues of Mechanism of action of toripalimab. I'll subsequently have Dr. Dias address your secondary question, which is of the potential combinations in these other indications, including small cell therapy agents. Theresa?
Yeah. Thanks, Robyn. We are excited to see yet another positive phase III clinical study with toripalimab, and particularly in a difficult tumor that has not shown benefit with some other PD-1 antibodies. These positive survival results are consistent with our preclinical studies, showing that toripalimab has more potent activation of T-cells compared to pembrolizumab. I think that really sets it up well to really think about combinations. I'll let Rosh expand further.
Thanks, Theresa, and thanks, Robyn, for the question. I think you're quite right. First of all, looking at small cell lung cancer, I think there's a real unmet need here. You know, it represents about 15%-20% of all lung cancers. Extensive stage continues to have a poor prognosis, and the current therapies that are out there continue to have marginal benefits. With that in mind, I think we are very excited about the benefit in both PFS and OS, just as I think you know, were our co-primary endpoints. I think if we look at the overall space, you know, I think this data set continues to add to the breadth of the data available across multiple different tumor types.
As we mentioned for lung alone, we have CHOICE-01 now in on small cell lung cancer. We have NEOTORCH in peri-operative and now small cell lung cancer, all showing positive results. I do think that this sets us up really well for combinations across small cell, but also other forms of lung cancer, and then also additional tumor types with our additional data sets.
Robyn, just an additional remark with respect to this. When we selected toripalimab from a broad array of available PD-1 agents, 3 years ago, we consistently saw it outperforming other agents, such as pembro in various in vitro and cell-based studies, although we didn't quite understand all the implications of it now. I think it's very rewarding, 1st of all, to see the mechanism of action story read out, as Dr. LaVallee indicated, but it's also now very rewarding to see this read out in several cancers where toripalimab continues, as we said, to demonstrate a really very potent track record here as far as efficacy. With that, I think you had a follow-up question on UDENYCA, perhaps you said?
Yeah. And one small one. I mean, given that it's an Asian-based study, I mean, I'm sure that doctors will be super excited to see the detailed data. Do you have any sense of whether it be in a publication or presentation on that? The UDENYCA question is really about the auto-injector and the fact that you're gonna have the auto-injector, the on-body device, and the prefilled syringe. I'm just trying to get a better sense of, you know, how do payers view the auto-injector? What are you getting as an early read on the interest for this auto-injector and that being differentiated now? You know, so giving you about three, and just help us tease out, like, how do we think about these three products taking share in different markets? Thanks.
Thanks. That's a great question. I'll let Paul frame that out for you. First of all, what the differentiated value proposition is for the auto-injector compared to the various dosage forms which are on the market today. Secondarily, some of the progress that we're making with payers on that front. Paul? Hey, Robyn. Thanks for your question. Yeah, we're excited to launch the auto-injector later this month, and we expect it'll, you know, cause some market share stabilization this quarter and then, you know, really increase growth in the 2nd half of the year. I think what the auto-injector enables us to do in the market is to now compete in both the in-clinic segment against the competitive prefilled syringe competitors.
It also enables us to now compete more effectively in the at-home segment, where Onpro still has 43% share. It'll do that because of the patient benefits. There's really three important ones. First is the auto-injector will give patients more independence over their injection experience. You know, essentially, they'll be able to inject when and where they desire. The 2nd is ease of use. This can be delivered in less than 10 sec, you know, as opposed to wearing the on-body for an entire day and navigating through a 45 min injection time. Then the third is flexibility, so the patients who live far away or can't come back to the office can simply do this at home. We believe it's gonna be able to penetrate all segments of the market.
Our payer coverage is actually coming online very nicely. Where we have coverage today, we've got confirmed coverage for auto-injector in over 90% of those plans. You know, the team is now working with customers, getting it on formularies, and we'll be ready to launch at the end of the month.
Thank you.
Thank you. Please stand by for our next question. Thank you. Our next question comes from the line of Salim Syed with Mizuho. Your line is now open.
Great. Good afternoon, guys. Thanks for the questions. I guess a couple from me, if I can. One on perhaps toripalimab and then another on UDENYCA. On TORI, Paul, you mentioned that you believe on NPC, you can reach a peak sales number around $200 million. I know you haven't disclosed your pricing framework here, but by my math, I would suggest something about like an $85,000 net price per patient. Just curious if you could point us in the right direction if, you know, that's ballpark-ish correct based on your $200 million peak, if you were to actually be able to get into all patients, all lines.
Yeah. Yeah. Let me 1st take that one, Salim. We, as a matter of policy, we don't comment on pricing for products which are not approved. After we have the product approved, we'll be happy to revert there on projected pricing. As Paul, you know, said in his remarks, we will have full 1st line and other lines of care, and we do have about, I think, 2,500+ patients per year. We're happy to chat a little bit about pricing post-approval.
Okay, great. Maybe if you could comment a little bit then on. I guess I'll just ask my 2nd question on toripalimab again. Maybe you can comment a little bit on the warehousing. It sounded like you guys are trying to build a registry of patients for NPC with your website. Can you just maybe give us an idea how many patients are currently in the registry and how many you plan to warehouse prior to approval? Thank you.
Yeah. Thanks, Salim. Being a rare cancer, the only, you know, company and brand that's gonna be entering the space, launching NPCFacts.com is really the work of our market intelligence and our customer knowledge, where we found that doctors and patients really don't have a qualified, you know, centralized place to go to get information about NPC. That was the real driving force there. Now adding a community where we can invite patients and their caregivers to join enables us to now educate them, we'll understand if they're localized or if they're metastatic, we can then communicate with them appropriately. We're gonna be turning up the media around that to really start cranking up the noise level there.
We'll be having our field team through appropriate disease state efforts, share the website with the accounts directly, so they can actually hand this out to their patients as they come in. We'll be reporting out on actual numbers on that. So far we like what we're seeing there.
I would add the additional comment, Salim, that, if approved, we will be the only agent approved by FDA for this terrible disease. We feel that we have a responsibility to reach out to these patients and find these patients and educate them. These patients are otherwise progressing without toripalimab. As Rosh indicated, the benefits of toripalimab treatment are really substantial. We feel a tremendous responsibility to reach out to these patients and let them know there's hope.
Okay. Thank you so much, guys. Thank you.
Thank you. Please stand by for our next question. Our next question comes from the line of Michael Nedelcovych from TD Cowen. Your line is now open.
Thank you for the question. I have two on toripalimab. The 1st, and you hinted at this already a little bit, but I'm curious if you have a sense of whether there's any off-label use of other checkpoint inhibitors in NPC that you may have to displace once toripalimab is approved. I realize there's no approved checkpoint inhibitor. Secondly, when we think beyond NPC, it would seem, given a potentially differentiated mechanism of action and a potentially differentiated clinical profile, that the world is your oyster. How will you go about selecting the next set of indications to advance into pivotal trial? Thank you.
Thank you, Mike. Thank you very much for the question. I'll let Dr. Dias address your 1st question, and then Dr. LaVallee can address the mechanism of action questions subsequently. Rosh?
Thanks for the question. I'll just reiterate a couple of points that we mentioned earlier. First of all, there are no approved therapies for nasopharyngeal carcinoma in the U.S. What that means is for the current standard of treatment, typically chemotherapy, gemcitabine, cisplatin, typically. Even though there is not an indication for other immunotherapies, there is the NCCN does include a couple of other therapies as potential treatments, but that importantly actually is on the basis of our dataset, because there are no positive datasets in NPC for the other immunotherapies nor an indication.
Teresa, can you comment on how the mechanism of action brings forward other potential combination therapies with toripalimab or ILT4 and so on?
Yeah. I think seeing the increase in potency on T-cells, which is really the true mechanism to be able to activate antitumor immunity and seen across three large phase III studies, the NPC JUPITER-02, the CHOICE-01 non-small cell lung cancer study, and the JUPITER-06, the ESCC study that was published in Cancer Cell, that toripalimab in front line studies in combination with chemotherapy works irrespective of PD-L1 status. Really lends itself to combinations to really target mechanisms of resistance in those tumor types. Our pipeline includes ILT4, which is looking at macrophages, which is a known resistance factor in diseases such as small cell lung cancer. We'll be looking at the disease positioning based on the mechanisms.
As we've stated a few times, we're really engaged with a number of other companies that have compounds with phase II data to help us position Tory in disease based on a strong clinical hypothesis. I think later this year, you'll be seeing some nice development plans there.
Thanks for your question, Mike.
Thank you.
Please stand by for our next question. Our next question comes from the line of Douglas Tsao of H.C. Wainwright & Co. Your line is now open.
Hi. Good afternoon. Thanks for taking the questions. Just question on CIMERLI from me, I'm just curious in terms of the accounts that have adopted it, are they switching all their ranibizumab volume to CIMERLI, or are they typically still splitting it between CIMERLI and Lucentis?
Thanks for your question, Doug. Paul, do you want to take that one? Go ahead.
Sure. Thanks, Doug. Yeah. As of today, our source of business from a patient standpoint, is coming from a combination of new patient starts as well as conversions from other anti-VEGF therapies, including Lucentis. We expected this and that's what we're seeing in the market.
Did you have a follow-on question, Doug?
Also just in terms of YUSIMRY's launch, I'm just curious, do you have a sense or have you been able to start to make some progress or finalize agreements with payers? Because from, you know, that seems to be a real focus of your strategy, just given the fact that you're not gonna really be promoting into those indications.
Well, I think it's fair to say that the focus of any Humira similar market participant competitor will be payers insofar as payers and PBMs are the primary determiners of formulary selection for this product. That being said, we have also previously indicated that we won't be making any comments regarding pricing for particular payers conversations until after the launch in July. That's a fair question for our August call, which we'll talk about Q2. No further comment on that particular point at this point.
Okay, great. Thank you.
Thank you. Please stand by for our next question. Our next question comes from the line of Balaji Prasad of Barclays. Your line is now open.
Balaji?
Balaji, are you there? Your line is open.
Let's move on to the next question, operator, please, and come back.
Yes, I will. Thank you. Please hold for the next question. Our next question comes from the line of Ash Verma of UBS. Your line is now open.
Hi there. Congrats on the progress. Thanks for taking my questions. I had one on Tory and one on, you know, YUSIMRY. On toripalimab, maybe I missed this, like from FDA's point of view, is the key determination in the NPC approval just the site inspection, or does FDA still need to make up its mind whether it will or will not, you know, adopt regulatory flexibility as it looks for China study PD-1? I was just curious. I know that there has been a paper that was published in Lancet a couple of years ago, where they commented on NPC and HCC being these indications of high unmet need.
Do you have like, a confirmation from the FDA if that's not an issue anymore? Does that apply to any other indications? That's my 1st question. On 2nd, similarly, I think you mentioned the mid-single-digit royalty to be paid until mid-2024. Just wanted to understand if I heard that correctly. Is that like a industry standard term that you got and there's no royalty that you need to pay after 2024, it is just like based on your launch timeline?
Well, let me take the last one 1st. Okay? What McDavid stated was that we had a low single-digit royalty on UDENYCA up to 2024, not CIMERLI.
Okay.
CIMERLI is a different financial arrangement, in which we have a royalty profit split with our licensee. Slightly different, if that's clear. With regards to your question of regulatory flexibility, I'll let Dr. LaVallee address the issue of what comprises regulatory flexibility for the FDA, what the status of that is, and the consistency of their comments, particularly as it applies to NPC. Theresa?
Yeah. Thanks, Ash. It's complex, as you stated, they have enumerated several times NPC warrants regulatory flexibility, both in The Lancet Oncology article and The New England Journal of Medicine article by Pazdur. The way that they look at it is severalfold. One, on the epidemiology of the disease, the approved available therapies, and the applicability to U.S. medical practice. NPC is one that really, if you will, gets a get out of jail card free on all of those boxes, particularly given the lack of approved treatments and the profound benefit that we've observed with toripalimab, both in combination with chemotherapy in the frontline setting, in monotherapy, and 2nd and later line. The only thing when you miss a PDUFA date without a letter, it usually just means the FDA can't complete what they need to do.
They've said repeatedly about not being able to travel to China last year due to the COVID-19 travel restrictions. I think what speaks volumes is even in the Pink Sheet a couple weeks ago, the FDA stated they had not reinstated doing inspections in China. They had told us repeatedly, given the Breakthrough Therapy designation and the meaningful clinical benefit that we would be at the front of the list. The fact that ours is scheduled this month tells you we're at the front of the list, and I don't think they would be using their resources to go places where they had worries.
Externally and, internally, the FDA has been very consistent that nasopharyngeal cancer warrants regulatory flexibility.
Great. Yeah, that's great to hear. Thank you so much.
Thank you for your question. Please stand by for our next question. Our next question comes from the line of Chris Schott of J.P. Morgan. Your line is now open.
Great. Thanks so much for the questions. The 1st one was just on UDENYCA. I'm still trying to get my hands around the, I guess, flow-through of the competitive dynamics for the traditional presentation and how insulated basically the auto-injector and on-body opportunities are from that. Obviously, company's in a much improved competitive position with these approvals. I guess, does the more competitive environment for the traditional product impact the opportunity for the new presentations? Do you view them as almost like kind of separate markets as the, we think about where pricing could shake out, et cetera, for these?
Thanks, Chris. I'll let Paul reply to your question with respect to PFS and auto-injector presentations, the competitive dynamics. Paul.
Yeah, Chris. When you think about the pic for the rest of the market, it's bifurcated into two segments. There's the in-office segment where the largely the patients come back to the office, and that's predominantly been where the prefilled syringe presentations have been competing. The auto-injector can be used in that in-office setting based on nurse and patient preference. It'll be billed under the same Q code and reimbursed through the same ASP. The differentiated device enables us to compete there. The other part of... That's, you know, 57% of the market.
The at-home segment where Onpro has largely had a dominant share is where the auto-injector will be able to offer a new alternative. In that case, you know, it'll be on the differentiation and the type of patient experience that the patient can realize using a simple, easy-to-use auto-injector versus wearing the on-body device. When we add the on-body, you know, if approved later this year, now we'll have, you know, the total solution for customers. Whether they're in the office, whether they're at home, whether they're in a hospital or a clinic, they'll have three presentations to meet the unique needs of the providers and the patients.
We believe that will put us in a strong competitive position with the franchise and will enable us to grow share later this year and in the coming years.
Great. Can I just follow up on the auto-injector versus on-body? I guess of those two opportunities, what do you see as the bigger opportunity? Because it seems like, you know, one's kind of a unique presentation to Coherus, versus the other's obviously a large segment of the market that you'll be the only kind of competitor, I guess, versus Amgen.
Well, listen, we're going to launch at the end of this month, and, you know, we'll really see how, you know, customer receptivity unfolds here. We're very, very excited about based on what we've heard now. I think at the end of the day, Chris, what's going to happen is, you know, patients are going to choose which type of experience they want, and the nurses are going to be key constituents in helping to identify which if it's the auto-injector or the on-body that's going to best fit them. We want to be the brand that offers all three so that we're positioned, you know, strongly. Depending upon whatever the patient and the doctor prescribes, we want to be the total solution for them.
One additional point I would make, though, Chris, is that with the non-body system, it's, you know, it has to be filled by the nurse, attached to the patient, activated. The patient walks around with it for 24 hours. There's about a 3 hr period that the patient is set aside for the injection. Then there's a 45 min injection period in which the patient's basically doing anything. There's a sense, we think, with the patients of a, of a loss of control. Your therapy is controlling you, right? People are living with cancer, right? It's very attractive for a patient to, you know, be able to be administered with an auto-injector at the time of their choosing. I think that's a very powerful patient empowerment that we have seen very strong receptivity in the market.
To your question as to which segment it'll take the most from, I think it'll probably take a share from non-PFS, that is the on body. It's a new segment, also the PFS. It's genuinely a new unserved segment.
Great. One just last one for me. I know you're not gonna comment on pricing on the biosimilar Humira side of the market till it launches. Just any observations or surprises or thoughts at all on the, I guess, the market formation so far with the 1st biosimilar that's launched? Is that generally trending as you would have anticipated for these, I guess, 1st three or four months in the market?
I think the, you know, I think it's a fair question, but I believe that the jury is out at this point. I think we've only had one team launch, you know, AMJEVITA. You know, the results have been made public and so on. I think you just have to really see. I don't think market formation has really started for the Humira biosimilar market. I don't think it will until after the July date when ourselves and other some other market entrants come in. I think that's the point where you start to see things happen.
Great. Thanks so much.
Thanks, Chris.
Thank you. Please stand by for our last question. Our last question comes from the line of Jason Gerberry from Bank of America. Your line is now open.
Hey, guys, this is Bhavin Patel on for Jason Gerberry. Two questions for me. The 1st one is, we've seen the 1st price increase for UDENYCA in tandem with the auto-injector launch. Should we expect to see pricing sort of steady-state from here, or are there more price increases to come as the new formats come to market? The 2nd question is going back to your March 2022 investor day, where you set 2026 targets, how are you thinking about the 10% market share goal that leads to a $1.2 billion target as you transition to the commercial launch phase for multiple products? Thank you.
All right. Thanks for your question. With respect to UDENYCA pricing, do I understand correctly that you stated there was a price increase with the-
Yeah
additional presence?
From the CMS data.
Oh, you mean the ASP increase that just occurred?
Yeah.
Paul, could you explain the ASP increase?
Yeah, sure. Just to clarify, UDENYCA list price for the auto-injector will be the same price as the pre-filled syringe, which is about a 35% discount to Neulasta. As it relates to the ASP, you are correct that in the 2nd quarter, we did have a 4% increase in our ASP, which, you know, puts it, you know, amongst the highest of the established brands in the class, including the innovator. Higher ASP, you know, leads to higher reimbursement. That's why we've been very disciplined with management of ASP in preparation for these new presentation launches.
With respect to your summary question and market share, I would point out that this market is developing consistent with our expectations. The readouts that we got, you know, 1-2 years ago from payers about what was important to them, that is to say, you know, pricing, scale, robustness of supply, the auto-injector, you know, patient comfort. That's playing out pretty much as planned. We deliberately spent about $45 million to move into very large-scale manufacturing. That's approval that Dr. LaVallee, you know, got last quarter. I think we're well prepared in terms of scale for competing at 10%+ as we go forward. Just how long it takes us to get to that sort of benchmark in the market, we'll have to see given the dynamics.
I can say that we are totally geared up in all aspects of that with the device, with the scale, and with our cost structure for [guess].
If I could have one follow-up. Do you have any line of sight into competitor biosimilar Lucentis launches over the next 12 to 18 months?
Paul, do you wanna take that question?
Yeah, we're only aware of one competitor, ranibizumab biosimilar. From what we understand, they're not looking for a launch till 2024 based on their public statements.
I think the key issue, though, to keep in mind, with CIMERLI and Lucentis biosimilar market, is the impact on the Q code that we garnered deployed on April 1st. I had the opportunity in the last couple weeks to go out and visit a number of customers and discuss with them 1sthand, whatever barriers to adoption they may have had with CIMERLI and so on. Every single one of those customers, and I think I saw four different practices and four different states, and I talked to at least, you know, 30- 50, you know, physicians contained within those practices. They were all very enthusiastic about the impact of the Q code and its impact on their cash flow, their ability to be certain about reimbursement.
I think that's why you're seeing the acceleration in the market share and the uptake and some of the things even that we've seen some additional data came out today on April utilization. I think that follows directly from the Q code per our previous remarks, and, you know, direct feedback to me from the customers indicate that's the case also.
Great. Thanks so much.
Okay, great.
Thank you. At this time, I would like to turn it back to Denny Lanfear, the CEO of Coherus BioSciences, for closing remarks.
Thank you, operator. Thank you everyone for joining us today. As you heard, 2023 will be an exciting year of catalysts for Coherus, and we look forward to keeping you all updated on progress. We'll be at the Bank of America conference this week, and we'll be at UBS following that later this month. Talk to you all soon. Bye-bye.
Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Goodbye.