Good day, and thank you for standing by. Welcome to the Coherus BioSciences Second Quarter 2023 Conference 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 your question during the session, you will need to press star one one on your telephone. You will then 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 speaker today, Marek Ciszewski. Please go ahead. Thank you, Corey, and good afternoon, everyone, and thank you for joining us. We issued a press release earlier today announcing our Financial Results for the Second Quarter of 2023. This release can be found on the Coherus BioSciences website and is also attached to the Form 8-K that we filed with the SEC today. Today's call includes forward-looking statements regarding Coherus's 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, projections of expenses and revenues, projections of future market share for any product, our expectations for market opportunity for any indication, our expectations about completing the merger with Surface Oncology, timing of our return to being cash flow positive, and expectations about our future portfolio prioritization. All of these forward-looking statements include 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 about our ability to complete the merger with Surface Oncology or realize the anticipated benefits of that transaction, that are discussed in our press release that we issued today, as well as the documents that we filed 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. Second quarter 2023 results are not necessarily indicative of results of future periods. With me on today's call are Denny Lanfear, CEO of Coherus, 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 Lanfear. Thank you, Marek, and thank you all for joining us today on our Q2 2023 Earnings Call. This past quarter, we continued to make good progress on our strategy to build an innovative immuno-oncology company funded by revenues from FDA-approved products. Pursuant to that objective, the company demonstrated strong execution in Q2 across research, development, and the commercialization value chain. Specifically, we signed a merger agreement with Surface Oncology, a high science leading-edge IO company that shares our vision that impacting the tumor microenvironment potentially represents the next step change in therapeutic benefit beyond checkpoints. In a moment, our Chief Development Officer, Dr. Theresa LaVallee, will recap for you the mechanism of action synergies for toripalimab and SRF388, SRF114, the anti-IL-27 mAb, anti-CCR8 mAb. We'll also update you on our own proprietary asset, ILT4, which continues toward IND filing. With respect to development, Teresa and Rosh Dias, our Chief Medical Officer, will recap for you projected timings of data emerging from various ongoing studies across the pipeline. Teresa will update you, of course, on the potential toripalimab approval. With respect to commercial performance, we saw a strong execution across the products and the presentations this quarter, with net product revenues of $58.5 million, almost 2x Q1. Our UDENYCA strategy to manage average selling price to support follow-on presentation launches of the auto-injector and on-body device has been successful. We launched the UDENYCA auto-injector in April and are pleased with the market reception. We continue to project UDENYCA on-body approval and launch this year. Regarding CIMERLI, as you recall, the reimbursement Q-code was deployed April 1st, and we projected a subsequent increase in market uptake. This has now occurred. Paul Reider, our Chief Commercial Officer, will provide additional background and color. Additionally, we have successfully launched YUSIMRY, our Humira biosimilar, with a highly innovative pricing addressing unmet access needs, providing low-cost alternative to high-priced competitors. Finally, our Chief Financial Officer, McDavid Stilwell, will report on our financial position, provide additional color on how the Surf merger will allow us to reduce our projected spending over the 2023/2025 planning period. We continue to focus sharply on holding the line with expenses while driving the top line. It's our objective to reach cash flow positive in 2024. Now, with that, I'll hand it over to Paul. Paul? Thanks, Denny, good afternoon, everyone. We are now at the midpoint of our 18-month, five-product launch effort. Three products have launched over the last nine months, we are executing plans to launch two more by the end of the year. Our total number of marketed assets will have increased from one to six over an 18-month time period. We believe these product launches will drive top-line revenue growth over the coming years. Combined CIMERLI and UDENYCA net revenue for Q2 was $58.5 million, an increase of 81% over Q1. I'll now speak to each brand. We'll start with CIMERLI, our biosimilar to Lucentis. Our strategic approach to the market is first, to maximize the conversion of existing Lucentis business, and second, to grow share through new patient starts and conversion from other anti-VEGF products. The primary catalyst to CIMERLI sales acceleration was the product-specific Q-code, which was successfully implemented on April 1st. This facilitates seamless, timely billing and reimbursement for retinal practices. CIMERLI net sales in Q2 were $26.7 million, compared to $6.2 million in Q1, driven by a quadrupling of demand quarter-over-quarter. CIMERLI market share within the ranibizumab class also more than quadrupled to 17% in Q2, compared to 4.1% in Q1. During Q2, we increased the cumulative number of accounts that ordered CIMERLI by 75% to 321, and of those, 72% have reordered. New accounts continued to grow in the first 3 weeks of July, with another 91 accounts ordering CIMERLI, bringing our total to now 412. In Q2, market share among ordering accounts was 45%, which reflects the potential of CIMERLI once accounts begin adopting. Reordering reflects new patient starts and conversions from other products, with the chronic nature of the disease and frequency of injections, this results in compounded growth. Therefore, we continue to expect that 2023 CIMERLI net revenues will exceed $100 billion. I'll turn to UDENYCA. UDENYCA net revenue grew 21% quarter-over-quarter to $31.7 million, compared to $26.2 million in Q1. This increase was driven primarily by a 10% increase in overall demand from our base prefilled syringe business. UDENYCA market share in Q2 was 12.2%, up from 11.5% in the prior quarter. These share gains have continued in July. As you know, the pegfilgrastim prefilled syringe segment has been increasingly competitive. Our strategy has been to balance price and share in order to maintain a strong ASP in advance of our launches of two new presentations, with the longer-term objective to regain share. We launched the UDENYCA auto-injector commercially in June. This presentation represents the first innovation in the pegfilgrastim class in 8 years and addresses a large market segment unserved by Neulasta Onpro, Amgen's on-body device, which still retains 42% of the market. Later this year, we anticipate launching our third presentation, UDENYCA On-Body Injector. If approved, which will compete directly with Neulasta Onpro. We believe the UDENYCA franchise is well-positioned to regain market share beginning in the second half of 2023. Turning now to YUSIMRY, our biosimilar of Humira. The high cost of adalimumab treatment is a problem for the healthcare system and for many patients. Our patient-centric strategy is to provide YUSIMRY at a single, transparent, low price. We launched YUSIMRY on July third at a list price of $995 per carton for 2 auto-injectors, representing a discount of more than 85% to Humira. We are working with multiple partners to make YUSIMRY available to patients. YUSIMRY is available for sale through retail channels, including the Mark Cuban Cost Plus Drug Company and through its Team Cuban cart at independent retailers nationwide. We are also working with specialty pharmacy partners, such as Superior Biologics, which services more than 1.5 million patients across the country. We expect to sign on more distribution and PBM partners in the coming months. The adalimumab market is highly competitive. Humira retains formulary position during this market formation period on nearly all PBM and health plan formularies. We expect steady growth for biosimilars in 2024, and then significant acceleration of biosimilar adalimumab adoption with the implementation of the Inflation Reduction Act in 2025. We continue to target up to 10% unit share of the adalimumab market for YUSIMRY, coming in the 2026-2027 time frame. Our low YUSIMRY operating expenses will allow us to generate good YUSIMRY operating margins and enable us to compete for the long term in the adalimumab market. I'll now provide an update on toripalimab. Launching the company's first immuno-oncology product is a critical step forward in the advancement of our IO franchise. Our mission is to extend cancer patient survival, offering new hope to patients. nasopharyngeal carcinoma is an excellent example. Today, the approximately 2,000 NPC patients diagnosed annually in the US have no FDA-approved treatments, including IO therapies. NPC clearly constitutes a high unmet need. toripalimab is a next-generation PD-1 inhibitor, and if approved, will be the first and only PD-1 inhibitor in the U.S. indicated for relapsed or metastatic nasopharyngeal carcinoma. Given the impressive final overall survival data presented in ASCO and feedback from the top head and neck KOLs with whom we engaged at the conference, we believe toripalimab plus chemotherapy will establish a new standard of care in NPC in all lines of therapy, including first line, and will be practice-changing. We feel confident toripalimab plus chemo will gain a dominant market share and estimate the NPC market opportunity at peak could reach up to $200 million. During our Q1 call, I announced the launch of NPCfacts.com, which is designed to be a primary source of C-state information for patients and their caregivers to learn about NPC. We've also launched a sister site for healthcare professionals. Our aspiration is to identify and appropriately engage with all NPC patients or their caregivers in the US by the end of the year. I'm pleased to report that since launch, we've enrolled over 1,500 NPC patients and caregivers into our community. We will be ready to launch and educate doctors on toripalimab's differentiated mechanism of action and the impressive overall survival benefit demonstrated in NPC and irrespective of PD-L1 expression status. We are ready to launch toripalimab directly upon potential approval. With significant overlap between UDENYCA customers and toripalimab-targeted prescribers, the launch of toripalimab is being efficiently integrated into our existing oncology commercial structure. With that, I'll now hand it over to Teresa. Thank you, Paul. Good afternoon, everyone. Let me begin with a regulatory update to date. Coherus continues to demonstrate excellent drug development execution from preclinical studies through regulatory approval of new products that we then pass on to our commercial colleagues to deliver to the market. A year ago, we projected 5 new product launches through year-end 2023. We are now more than halfway towards that target. Similarly, was approved last August with interchangeability. The YUSIMRY auto-injector presentation and manufacturing scale-up supplements were both approved in first quarter 2023. We launched the drug in July. UDENYCA auto-injector, the first innovation in the pegfilgrastim market in 8 years, was approved in March 2023. Launched in June. The FDA review of the UDENYCA On-body Injector supplement is progressing towards anticipated approval later this year. Additionally, the toripalimab BLA for NPC review now has all required elements completed or scheduled. The clinical site inspection is planned to be completed by early September, and the manufacturing inspection was completed by the FDA in May, with only a few observations that were all readily addressable. We want to thank the FDA for prioritizing this Breakthrough Therapy BLA with the scheduling of these on-site inspections. We still believe an FDA approval decision is possible in third quarter. In the absence of a PDUFA date as a deadline, it is possible the FDA action may take into the fourth quarter of 2023. Given there are no approved treatments for NPC patients in the United States and the very positive, statistically significant, and clinically meaningful overall survival data presented at ASCO, as well as Breakthrough Therapy designation for toripalimab at NPC, we are hopeful the FDA will act in a timely manner following the completion of the co- clinical inspection. toripalimab is a next-generation PD-1 inhibitor with potent activation of T cells, including demonstrating clinically meaningful activity in tumors that are less inflamed, such as triple-negative breast cancer. toripalimab is the foundation of our IO franchise, and we are excited to explore clinical opportunities to extend patient survival with novel combinations, particularly with agents that target elements of the tumor microenvironment that have been shown to cause PD-1 resistance. With our recent announcement of the signing of the merger agreement with Surface Oncology and our in-house developed ILT4 antibody, we are assembling a compelling novel IO pipeline. Two well-characterized immune suppressive cell types are macrophages and Treg cells. SRF388, targeting IL-27, an immune suppressive cytokine that dampens immune activation of lymphoid cells such as T cells, B cells, and NK cells, is secreted in many tumors by M2 macrophages. CHS-1000, an antibody directed at ILT4 and M2 macrophages, causes macrophages to polarize to a more immune responsive phenotype. With the merger with Surface, we will have SRF114, an ADCC-enhanced antibody that selectively binds and kills tumor-resident Treg cells. That is to say, it was designed to target Treg specifically in the tumor microenvironment, systemically, and thus the potential to reactivate antitumor immunity without broad autoimmune side effects. Combining each of these agents with toripalimab has strong mechanistic rationale and preclinical data to show improved antitumor activity. Each of these programs has a rich scientific data set to indicate which tumor types these mechanisms are most prevalent in, including lung, head and neck, liver, and breast cancers. We look forward to the Surface Oncology merger closing later this quarter, and to hosting an investor event in the fourth quarter to discuss our portfolio prioritization and development plans. I'll now turn the call to Rosh. Thanks very much, Theresa. Good afternoon, everyone. With respect to toripalimab, several strong data sets were presented at ASCO in June across different tumor types and settings. Together, these showcase the consistency of activity of toripalimab as a next-generation PD-1, and we remain excited about its potential to form the backbone of combinations with other novel agents, particularly with our merger, Surface Oncology. Data highlighted at ASCO included, first of all, the final overall survival analysis of our pivotal study in nasopharyngeal carcinoma, with a significant benefit in overall survival in the toripalimab arm, with a hazard ratio of.63, with a consistent effect on overall survival across all PD-L1 states. This is, of course, particularly important as there are no currently approved immunotherapies in NPC. Updated data sets were also presented in non-small cell lung cancer, with a final overall survival analysis, the pivotal CHOICE-01 study comparing chemotherapy ± tori, showing a hazard ratio of.73, favoring the tori arm, as well as positive data in the NEOTORCH study, a large phase III perioperative non-small cell lung cancer study, showing a hazard ratio of.44 for event, for event-free survival favoring the tori arm. Finally, data from TORCHLIGHT was also presented at ASCO, showing a statistically significant benefit in triple-negative breast cancer. Earlier this year, our partner, Junshi, also announced that the phase III study of tori in small cell lung cancer was positive, with results anticipated to be presented later this year. Junshi will also be running a large, multinational phase III study with an anticipated start later this year, set to include U.S. sites exploring toripalimab in combination with their CTLA-4 antibody as consolidation therapy in limited-stage small cell lung cancer. This will be the first multi-regional r \egistration study for toripalimab that includes U.S. patients. This is a great example of how combination treatments across tumor types could enable broader registration opportunities for toripalimab in the U.S. Regarding our TIGIT, our phase I/IIa study, looking at the tori TIGIT combination, is currently active in the U.S. and will generate data in U.S. subjects with this novel bio combination. We noted the encouraging Morpheus data at ASCO, evaluating the atezo-bev TIGIT combination in HCC, or hepatocellular carcinoma, a tumor type that we were planning for the expansion phase in our current phase I, IIA study, given the high disease linkage with high PD-L1 expression. HCC is also an indication that has shown promising activity with SRF388. Evolving TIGIT data from other competitive programs will continue to inform our further development of this combination, as we have previously stated. Regarding our recent merger with Surface Oncology, we are very excited about the potential to combine the Surface assets with toripalimab. SRF388, the IL-27 asset, has shown encouraging activity, both as monotherapy in non-small cell lung cancer, as well as in combination with immune checkpoint inhibitors in hepatocellular carcinoma. Importantly, responses have been shown in prior PD-1 experience as well as PD-L1 low subjects. We anticipate presentation of the full available data sets in quarter four this year for the monotherapy data in non-small cell, and quarter one next year for the combination data in HCC. After we complete our Surface merger, we will have the opportunity to work with a wider portfolio, targeting now not only the T cell, but also the tumor microenvironment, with the potential synergies that that could bring to improve patient benefit. We'll look at this broad portfolio over the coming weeks with an eye on as to how to best invest in and prioritize these assets, taking into account timelines, the competitive environment, unmet medical needs, and potential patient benefit, probability of technical and regulatory success, costs, and other factors. We look forward to sharing more specific clinical plans across assets and tumor types later in the year. I'll now turn the call over to our Chief Financial Officer, McDavid Stilwell. McDavid? Thank you, Rosh. Today, we reiterate our earlier financial guidance for 2023. We project revenue growth from accelerating similarly sales and the launches of YUSIMRY, the UDENYCA auto-injector, and once approved, the UDENYCA onbody injector and toripalimab. For the full year, we expect to record at least $275 million in net sales, with at least $100 million of similarly net product revenue. We continue to tightly manage our expenses, even with the expected addition of Surface Oncology-related operating expenses in the fourth quarter, we anticipate meeting our prior 2023 guidance range of $315 million-$335 million for our combined R&D and SG&A expenses. This range excludes any upfront or milestone collaboration payments or the cost of the Surface Oncology merger. For my review of second quarter financial results, I'll touch on just a few highlights, as the details are in the press release, 8-K and 10-Q that we filed this afternoon. Net revenue was $58.7 million during the three months ended June 30th, 2023, representing an 81% increase over the prior quarter. This included $31.7 million of net sales of UDENYCA and $26.7 million of net sales of CIMERLI, as well as approximately $200,000 in royalties we received from a license to our adalimumab formulation. Cost of goods sold for the three months ended June 30th, 2023, was $24.8 million. Recall that UDENYCA COGS includes a mid-single-digit royalty on net sales payable through the first half of 2024, and CIMERLI COGS includes a low to mid-50% royalty on gross profits. We continue to focus on keeping tight control on operating costs. Research and development expense for the three months ended June 30th, 2023 and 2022, was $23.3 million and $41.6 million, respectively. The significant decline in R&D expense compared to the prior year quarter primarily resulted from the reduction in scope of the toripalimab collaboration agreement, and also the capitalization of certain YUSIMRY costs into inventory in 2023 that were expensed in R&D during the second quarter of 2022. We are beginning to realize the savings from the cost-cutting program we announced earlier this year. Primarily as a result of reduced headcount, selling, general and administrative expense declined. SG&A was reduced to $45.1 million in Q2 2023, from $51.3 million in the second quarter of 2022. With higher revenue and lower expenses, we reported a lower net loss for the second quarter of 2023, $42.9 million or $0.49 per share, compared to a net loss of $50.2 million or $0.65 per share for the same period in 2022. We expect operating losses will continue to moderate as product revenues increase and as we continue to constrain operating expenses. Cash, cash equivalents and investments in marketable securities were $144.7 million as of June 30th, 2023, compared to $191.7 million at December 31st, 2022. We expect the Surface Oncology merger to add $20 million-$25 million in cash to our balance sheet at closing. We have also stated that the merger will reduce our R&D expenses through 2025 by approximately $50 million compared to budget. I'll now provide a bit more detail on our assumptions supporting that assertion. Prior to the Surface deal, our major planned R&D activities through the 2025 planning period included a large phase 3 clinical trial to expand toripalimab's label beyond MBC. We also planned a phase I, II clinical trial to evaluate CHS-006, our TIGIT-targeted antibody, in combination with toripalimab, followed by initiation of a phase II, III registration study, as well as completion of pre-IND activities for our ILT antibody and a phase I, II clinical trial. We had planned to advance 2 other preclinical programs to IND. Following the completion of the Surface Oncology merger, we plan a portfolio prioritization project to determine which programs are most promising and competitively positioned. We currently expect that we will advance SRF388 in combination with toripalimab for second-line non-small cell lung cancer, SRF114 in combination with toripalimab for first-line head and neck cancer, as well as certain other projects that make the cut. Multiple programs will not make the cut, and those we plan to stop, to not initiate, or to gate, pending additional competitor data, and we will provide additional details at our investor event in the fourth quarter. We're focused on ensuring the success of our new product launches and generation of the anticipated revenue growth, and we will continue to maintain tight control over our operating expenses as we aim toward a potential return to being cash flow positive over the course of 2024. I'll now hand the call to Denny for closing remarks prior to the question. Thank you, McDavid. We're pleased with our progress this quarter, and we're happy now to take your questions. Operator, please proceed. Thank you. We will now conduct the question and answer session. 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. Please stand by while we compile the Q&A roster. Our first call comes from the line of Yigal Nochomovitz of Citigroup. Yigal, you're on. Hi, Denny and team. Thanks. Regarding UDENYCA, could you talk about the relative contribution of the auto-injector, which was launched in the middle of the quarter, and whether you're seeing a mix shift away from the prefilled syringe. The auto-injector is growing share as well. Then more generally, once you get the OBI on the market as well, could you provide any broad comments around the, the relative split in the market between prefilled syringe, auto-injector, and, and the OBI? Thanks. Thank you for the question. I'll have Paul Reider, our Chief Commercial Officer, address that for you. I'll just preface his remarks by saying, however, that we view UDENYCA, of course, as our foundation product and the, and the base of our, our sales. So our efforts in bringing forward all these various presentations is really to, to solidify the revenue stream for the mid and long term with UDENYCA. With that said, I'll let Paul go ahead and answer your more specific questions regarding relative contribution of auto-injector and PFS and the future of our OBI. Paul? Yeah. Thank you, Denny. Thanks for your question, Yigal. Just to, you know, recap, the market here is about 42% in the at-home market, and then the other 58% in the in-office segment. The PFS operates in the in-office segment today. The launch of the auto-injector and the OBI is going to enable the UDENYCA franchise to really target that 42% of the market that's dominated now by Onpro. That equates to about 550,000 units per year. In June, because we just, you know, we just launched the auto-injector in June, you know, we were still working through payer coverage. We were working through, you know, getting it on formularies, the operational aspects. It was relatively minor contribution to the overall UDENYCA business in Q2. Over the course of the second half of the year and then into 2024, we will now have 3 presentations to attack the entire market. The auto-injector and OBI will enable us 2 shots on goal into that 42% of the Onpro. It's hard to project right now, Yigal, what the actual split's going to be until we get all 3 into the market, and we see what the payer coverage is gonna look like, the competitive dynamics. Suffice it to say, we feel very, very encouraged about our opportunity to be able to differentiate the 3 presentations and grow share over the course of the second half of the year and into 2024. Thanks. Then just two other quick ones on CIMERLI, obviously, a very, very strong performance in the second quarter following Q-code. can you just comment briefly on how much of that was contributed from inventory or stocking? Then on the broader question, just of the, the sales trajectory for the whole company, you reiterated the guidance of at least $275 million. Obviously, you were 10% above the upper end of guidance this quarter. Are you thinking about raising the, the guidance for the full year? Thanks. Paul, Paul, would you address the, we'll take, we'll give you 1 out of those 2, Yigal, and then we'll move on to another caller. Go ahead, Paul. Can you just answer the question of the CIMERLI sales and where that came from? Yeah. Yigal, you know, as, as we reported, Sorry? As we reported, expected, the activation of Q-code was gonna unlock, you know, the, the reimbursement hurdle, and that occurred. All of the, the, the sales increase for CIMERLI was driven by the quadrupling of demand. While you do see maybe some higher levels of inventory, which is normal when you're in a high launch acceleration period like we are now. When you have, you know, dozens and dozens of new accounts ordering it and ordering regularly, you're gonna see the wholesalers keeping inventory. Those sales were driven largely by demand growth and market share growth, organic into the business. As it relates to the, you know, to the guidance, you know, we're, we've, as McDavid mentioned, we're, we're maintaining guidance of $275 million for the year, with at least $100 million coming from CIMERLI. Yeah, I, I would say that we, yeah, I would say that we feel very good about the traction that we're getting in the market. For CIMERLI, in Q2, we like the forward trajectory that we're seeing with respect to that, the market uptake. I, I think that we've hit critical mass with respect to CIMERLI, we've administered more than 65,000 doses. I think once you earn the trust of the ophthalmologist, and they have confidence in the company and confidence in the product, I think you're in a better position. I, I think that we definitely have some strong momentum going in the second half of the year with CIMERLI. Thank you very much. Thank you very much. Please keep your questions to one and a follow-up, if you would, please, for time limit. Thank you very much. Stand by. Our next question comes from Robyn Karnauskas of Truist Securities. Robin, your line's open. Great. Thank you, congrats on all the progress this quarter. I guess my, my main question is, can Theresa, maybe you can give us a little bit more color about what is entailed for these on-site inspections that are scheduled and what logistically has to happen for the FDA? That'd be my first question, I have a follow-up. Yeah. Thanks, Robyn. So for approvals, there are always multiple inspections. You usually don't hear about them because they just happen in the background. With the COVID-related travel restrictions to China, it's been more burdensome. The manufacturing inspection happened, as you know, in May. We did have a remote regulatory assessment of the clinical site done already, and we will have the, the clinical site inspections are, are pretty straightforward, much more streamlined than a manufacturing inspection. Then it's a matter of compiling the different division assessments and coming up with an action. Typically, you work towards a PDUFA date, which is a deadline that brings everyone together, and we'll be collaborating closely with our RPM to try to get this done as quickly as possible, given how long it's taken to get all of these things scheduled. What I will say is that the FDA did honor their word by giving, saying that we would be at the front of the line. For both the manufacturing and the clinical inspections, we are one of the first to get inspected in China, and for that, I am very grateful. And, and do they Go ahead with your follow-up. Yeah, I was just, just to elaborate on that. They have to go over to China again, and they've already scheduled the exact date. I assume that they won't have the delay that they had before, like, they're set. The follow-on was just, you mentioned market share on UDENYCA going from 11% to 12.2. Now with the on body or with the auto injector, can you just talk a little bit about, you know, the cadence of how quickly that auto injector might contribute to uptake? Should there be, like, a steady stream of, of share increase, or would you think it's more like back-end loaded? Thanks. Yeah. Thanks for your question, Robyn. Yeah, I think with UDENYCA auto-injector, you know, it's, it's likely to expect more of a, a steady increase over the second half of the year as we continue to get payer access on board and start working, you know, on the operational implementation, particularly in the hospital segments, where you got to get through P&T committees and then get them into the order sets and the EMR. Hospitals don't move quick, so you know, it takes a little bit of time. Again, the most important thing is there's, you know, been really positive receptivity by the customers, you know, for having an alternative to Onpro for patients that, you know, want to go home, have an at-home injection experience, and the auto-injector fits that need. Really, it's just working through the operational and the and the payer access issues that, that we will continue to work on over the course of the quarter in the second half of the year. Great. Congratulations, guys. Thank you. Thanks, Robyn. Also with respect to the auto-injector, Paul may comment further, but I think that we put between 1,000 and 5,000 training devices of the auto-injector out in the field. Is that right, Paul? We have. Robyn, you've seen me demonstrate that as well. Yeah, yeah, the market receptivity is very high and, you know, a great job by the tech ops team to, you know, to provide a device that's so easy and flexible to use for, for patient convenience at home. Thank you very much. One moment for our next question. Our next question comes from Michael Nedelcovych of TD Cowen. Michael, your line is open. Hi, all. Thank you for the question. I know it's early days, but I'm curious if you could give us a sense of how the YUSIMRY launch is doing so far. Did the actions of any of your biosimilar competitors surprise you? I'm also specifically curious how your collaboration with Cost Plus Drugs is going so far. Do you see any early indicators that this channel could perhaps be more meaningful for you, for YUSIMRY than you initially thought, or that you might want to expand the collaboration to other products? Thank you, Michael, for the question. I'll, I'll put that one over to Paul Reider. I, I, I would say that we, generally speaking, we, we felt that the market did not need another high-cost alternative in this market. We felt the best place to be competitive was a low-cost alternative. The product has only been launched, I think for, you know, less than a month or maybe a month as of now. I think it's fairly early days with respect to a market formation or to make conclusions about how the market's going. Paul may have some additional color for you on your other topics. Paul? Yeah, thanks, Denny, and thanks for your question, Michael. You know, as a, as a matter of rule, I don't typically comment on the actions of our competitors. You know, what we really focused on was where we, you know, felt the opportunity was in this market. and that's to bring, you know, a transparent, low-price product to address this, you know, this exorbitant problem of, of the cost of adalimumab treatment. Our decision, you know, to partner with Mark Cuban's Cost Plus Drug Company really centered around two reasons. Number one, you know, both Mark Cuban and Coherus are innovators, and we considered biosimilar adalimumab entry as an ideal opportunity to partner together to innovate within the highest drug category in the United States. Second, we both share a mission to offer patients safe, affordable medicines at transparent prices, and YUSIMRY fits ideally into that model. How this unfolds over the course of the year, as we, you know, as we expand, you know, the coverage and the distribution network and, you know, educate, you know, providers, employers, healthcare systems about YUSIMRY and its price point is something that, you know, we're executing upon in earnest. I think we'll be able to report more on our performance in our Q3 call. Michael, just some additional comments to dovetail with Paul's remarks. We view, we view the build towards our, our targeted 10% market share as a long-term trajectory out to 2026 or 2027. We don't think this is a market where you come and have, you know, very, very high sales out of the gate. We, we think this market is gonna build over time, and our strategy is to build this market up over time as we go forward. Formulary access with the innovator in 2023 limits how much we can do this year. I think starting next year, and then more significantly into 2025, I think we'll see a lot more traction there. I would, I would just manage your expectations that way. Got it. Thank you. Thank you very much. One moment for our next question. Our next question comes from Douglas Tsao of H.C. Wainwright. Douglas, your line is open. Hi, good afternoon. Thanks for taking the questions. Denny, maybe following up on that last question or your last comment, you know, you expect this to take place over time and, you know, sort of being realistic about, you know, the contracting situation with AbbVie for 2023, does that suggest that your own strategy, you have an expectation that it will evolve, and that while, you know, you have not necessarily been that active with some of the large payers or for, or PBMs in 2023, that over time, you will look to increase your penetration there? Thank you. Yeah. Thanks, Doug. You know, AbbVie's been in this market for a long time. They, they own this market. You know, they're, they're the innovator, and I think there's significant incentives for AbbVie to continue to have significant market share as the market turns towards biosimilars this year. My point simply is that's just gonna take some time to work through all that. The IRA is gonna show up in 2025. I think that'll be an important event for traction. I, I would say a smoother, more linear trajectory for a market like this, as, you know, as opposed to the acceleration, you know, for example, that we're seeing under CIMERLI, right? Where you get something Q-code, and there's significant, you know, opportunity to move the market more quickly. I think each of these markets are just a little different, and I just think the trajectory is gonna be a little, little flatter more over time, but I think it'll, it'll pick up last half of 2024 and 2025 for sure. Okay. Then just a quick follow-up. In terms of UDENYCA, it sounds like most of the growth just came from the prefilled syringe. You know, do you have any comment what drove. I mean, we finally, it seemed that we started to see, you know, it's good, great to see that product start to move in the right direction again. I, you know, I'll let Paul take that one. Doug, I, I think that the ipilimumab market is, is very dynamic, you know, with people coming in and out and so forth. I think we've effectively managed our average selling price to that market to be attractive. We maintain a very high average selling price there, and I think that has yielded benefits and will continue to yield benefits, I think, across the additional presentations. Paul, any further comment on the, the performance of the PFS in Q2, or? Yeah, Doug, I, I think it's a combination of things that Denny mentioned, but also, you know, having additional presentation launches has created opportunities for the UDENYCA franchise, you know, where we didn't have before. So whether that's with payers or whether that's with, you know, clinics or hospitals, they see the value in having, you know, device options. Plus, I think, and I won't go into this for competitive reasons, but, you know, outstanding execution by the, by the commercial team on strategies that, you know, that are driving organic demand. That's bearing fruit, and we expect that to continue, you know, in the second half of the year. I think it's a great testament that year five into the life cycle, we're seeing the second wind for UDENYCA and with the device options, you know, we, we continue to expect market share, you know, growth in the second half of the year and beyond. Okay, great. Thank you. Thank you very much. Thanks. One moment for our next question. Next question comes from the line of Balaji Prasad. You are up. Good evening. This is Xiao on for Balaji. Thanks for taking our questions. Just a quick one on Tori. Seems like your partner, Junshi, announced that it was approved in China for extensive-stage small cell lung cancer in May based on positive survival results. If the OS and PFS are both better than current first-line options in the U.S. for extensive-stage small cell lung cancer, such as TECENTRIQ, would you consider changing your product strategy with Tori, as it could potentially fulfill an MS need in the U.S. market? And if I remember correct, the FDA has granted Tori orphan drug designation back in April 2022, which was after the lead ODAC. Thank you. Thanks for that question. That, that's a very interesting observation with perspective, Balaji Rosh Dias, our Chief Medical Officer, give the answer, address that for you, Rosh. Thanks for the question. You know, I, I said in my comments that the, small cell lung cancer data was positive. We're yet to actually present the data. We anticipate that that will be presented later this year. As you know, the current standard is etoposide, platinum, in terms of the current standard of therapy, plus or minus durvalumab or atezolizumab, based on actually a very marginal overall survival benefit for those two IO agents. I think as we look at the U.S., our strategy is, you know, I mentioned the fact that we will be initiating a earlier stage study in small cell lung cancer that's in limited stage, and that's it with our combination. Really outside NPC, our major focus will be with combinations. We do view toripalimab as a very good PD-1 next generation, which, which really will form the foundation of combination therapy. That's really our strategy, is be looking to indications over and above our current and NPC indication. You know, I think, I think it's really an excellent point. You know, the toripalimab continues to demonstrate really strong efficacy with a great safety profile in a number of settings, you know, monotherapy or in conjunction with chemotherapy. We think this sets it up very, very well for combinations. We have keen interest in pursuing combinations with a number of products, post-approval, of the NPC indication. For example, you know, ADCs or other combination agents. We expect to be busy on the deal front, once tori gets approved, to really more broadly proliferate its use, into oncology. Got it. Very helpful. Thank you. Thank you. One moment for our next question. Our next question comes from the line of Chris Schott at J.P. Morgan. Chris, your line is open. Great. Thanks very much. Just, just two for me. Just going back to biosimilar Humira in the market. I appreciate this will take some time, just given AbbVie's positioning, et cetera, but I guess I'm still trying to get my hands around, do you kind of think of this as payers and, you know, kind of the channel making annual decisions about either what co- product they're going to cover or how they're going to approach this? Do you think this is a market that's in flux, where you could see kind of multiple decisions being made in a, in a given year, just as we're trying to kind of evaluate the, the, you know, the evolution of this? The second question, I just want to make sure I've got my hands around this. I guess just following the surface acquisition and with the portfolio reorg, can you just help a little bit, just as we think about kind of 2024 OpEx relative to 2023, just directionally, is that a similar level of spend? Is it up next year? Is it down? I'm just trying to kind of balance the, the some of the synergies you're talking about, relative to what the baseline expense might have been otherwise. Just any directional color would be kind of appreciated there. Thank you. Thanks, Chris. Let me, let me take the first one with respect to the summary and, you know, the Humira biosimilar story, and then I'll let McDavid Stilwell address your questions about the surf reorg over the next two years. The directions on the spend. You know, I, I think that it's very, very early days with respect to the Humira biosimilar opportunity. There's a lot of people in the market. There's a diversity of pricing strategies, diversity of channel strategies going forward. There's, there's folks who have, you know, high, high and medium sort of WACs and, you know, low WACs and so on. I think that market formation is going to take a while for this to sort of shake out. I really wouldn't make any conclusions about that, maybe until we get into next year and see how things are kind of going. I think it's just way, way too early to say or call winners or losers. With respect to the Surf reorg and its impact on spend, I'll send that one over to McDavid Stilwell for comment. Yeah, Chris, I, I think it's, it's too early for us to be putting out there a direction for where R&D spend is going, specifically in 2024. I will tell you, though, that, you know, we, we are beginning to reap the benefits of the cost-cutting programs that we put into place this year, and we are intensely focused on constraining the expense line throughout this company, and we are also intensely focused on returning to being cash flow positive over the course of 2024. You know, all of that is, is, is very much top of mind for us as we operate this company and as we make decisions about, about R&D programs. We look forward to updating everybody in the fourth quarter after we've had our portfolio prioritization program, post-closing of the Surface Oncology acquisition. I think that'll be the most relevant, relevant, time point to be able to provide some more information on that. I'll just give you one more on that one, a little more color, Chris, is that we, you know, we do not anticipate starting any expensive phase III next year. Those, you know, with the way the portfolio is positioned, those are rolled into 2025 when we anticipate having traditional revenues to support that. You know, we're, we're not going to go out and bang out real expensive phase III studies to make, you know, hundreds and hundreds of million dollar commitments, right? As McDavid pointed out, we're really focused on driving the business back to profitability and cash flow positivity next year. So we're gonna, we're gonna start there. The other point I would make is, we have a very strong track record here of delivering on our projections for spending control. You know, last year we said we'd take our $435 spend down to about $3.25. We've done that. We did a RIF, and we said we'd recognize savings. We've done that. You know, we've gone ahead and, and delivered on what we said on the spending side. I think we're, you'll see us continue with that sort of very, very tight discipline. We don't have a lot of additional heads that we're going to add, maybe just a few with respect to the, the Surface Oncology merger. I, I think we're relatively tight-fisted when it comes to spending. Great. I appreciate the color. Thank you. Thank you. One moment for our next question. Our next question comes from the line of Jason Gerberry. Jason, your line is open. Hey, guys, this is Pavan Patel on for Jason. Two questions for me. First on Lucentis. As you look at the market opportunity, are you seeing any surprises in terms of pricing, brand share retention, or just the shift of market to other treatment alternatives? The 2nd on gross margins, maybe if you can provide some commentary on how you see gross margins in the 2nd half of 2023 and in 2024. Looks like we're seeing step downs even absent the one-time inventory costs. Just wanted to get some thoughts on how we should think about that moving forward. Thank you. Thanks. You know, we're, we're actually very pleased with the way the Lucentis biosimilar, CIMERLI market is shaping up for us. You know, I had the opportunity to attend the American Society of Retina Specialists meeting in Seattle. In fact, my entire commercial team did last weekend. We made a presentation there, and what really struck me about that was the, the way Coherus really is being embraced by the ophthalmologists as a very, very, you know, solid partner. As I indicated earlier, you know, we have over 65,000 injections now, and the ophthalmology market is one in which doctors have long-term relationship with their patients. They have these patients 10, 15, 20 years, and that means there's trust. What that translates to is that these ophthalmologists have to, in a very similar fashion, trust manufacturers and the companies. You know, they've had issues with new products that have come in, they really want to make sure that any product that shows up is safe and efficacious for their patients. What this means is that you, you have to sort of get a critical mass of administrations under your belt, then they know that it's a safe and efficacious product that's working well. We've done that, then they will adopt into your practice, now we've seen that, too, as, as Paul recited. You know, overall, we, we think that's going very well. I think Paul reiterated places where we're focused in terms of gaining the scripts. Paul? Yeah, You know, I think the getting through the, you know, the Q-code, you know, was really the, the primary barrier that opened up a lot of practices that were ready to adopt biosimilars that just, you know, wanted the, the ability to bill electronically and not take on that manual process. You know, I think what we're seeing in the market now is a real, is a real optimism around the role that biosimilars can play in the market. What CIMERLI brings to them in the ranibizumab class is a product that, you know, is interchangeable, which means that they can feel confident that they can switch a stable Lucentis patient to CIMERLI and get the same results. That level of confidence in the safety, you know, is really bearing out now in the experience that the doctors are seeing. They told us last week, you know, on multiple occasions, that the product is delivering on the clinical profile. All of that now, you know, just breeds, you know, continued optimism for the, for adopting CIMERLI and will, will help to contribute to share gains, you know, in the second half of the year. I think we're really hitting our stride there. Yeah, I think, just one last remark for Henry and McDavid. I think the interchangeability is, is really important. This is a non-glycosylated molecule, so this is, this is really an amino acid sequence, and we have exactly the same amino acid sequence, exactly the same formulation, exactly the same, you know, excipients and buffers and pH and so on. This is, this is really the, the, the, the same product being administered. I think that gives the physicians and ophthalmologists, a lot of comfort and, and confidence. As Paul said, you know, we're now past the reimbursement issue with the Q-code, so, I think we're rather bullish on them. McDavid, do you wanna follow up the other points? Sure. Our gross margin is obviously gonna be a function of the product mix and the cost of goods of the various products. As CIMERLI sales increase, CIMERLI has a larger influence on the overall gross margin, and CIMERLI cost of goods includes a low to mid-50% royalty on gross profits. As the product revenue mix evolves, so will the gross margin. Next year, YUSIMRY and toripalimab will have an increasingly influential roles in the overall gross margin as well. However, next, next year, the UDENYCA code of royalty comes off, right? Exactly. The Udenyca royalty, the mystical digit royalty we pay on the Udenyca net sales will roll off in July of 2024. That'll be a fantastic. That will. Yeah. Thank you. Thank you for your question. Thank you. Please stand by for our final question. Our final question comes from the line of Ashwani Verma from UBS. Ash, your line is open. Hey, guys. Thanks for taking my question. Just wanted to ask about the pricing on biosimilar Humira. Do you think this type of aggressive pricing is a one-off, or does this set the template for you to price future products going forward? Is this type of level of discount that you can get to for existing products much faster now versus what you were previously thinking? It just would be helpful to get some comments on that. Thanks. Thanks, Ash. I, I think that each of these products have to be priced, you know, specifically for the market that they're in. Our, our conclusion, as I indicated before, with respect to the Humira biosimilar pricing, is we really didn't need another high, high-priced, high-WAC competitor in the market. We felt this was the right place to go, and we think the strategy for this market is unique. You build from the bottom up with a very low price. That does not apply to the other markets. That does not apply to oncology or, you know, to PD-1s or even to UDENYCA. We have the highest, you know, one of the highest ASPs there for 5 years with UDENYCA. I think this, this particular pricing strategy is unique to what's going on over on the Humira biosimilar side of the business, which is part of BD and a number of other, you know, moving parts. Great. Thanks. Thank you very much. At this time, I would now like to turn the conference call back to Denny Lanfear for closing remarks. Thank you, operator. Thank you all for joining us on our Q2 2023 call. We're pleased with the progress that we've made so far. We look forward to seeing you on our, on our next call, which will be sometime in November. We further look forward to seeing you at Analyst Day, which will probably be in late November, December timeframe and with both the merger closure. Thank you. Bye-bye. Thank you. This concludes today's. You may now disconnect.