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Earnings Call: Q4 2022

Mar 6, 2023

Operator

Thank you for standing by and welcome to Coherus BioSciences' fourth quarter and fiscal year 2022 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker 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. I would now like to hand the call over to SVP, Investor Relations, Marek Ciszewski. Please go ahead.

Marek Ciszewski
SVP of Investor Relations, Coherus BioSciences

Thank you, Latif. Good afternoon, everyone, and thank you for joining us. We issued a press release earlier today announcing our financial results for the fourth quarter of 2022. 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'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, the ability of the FDA to complete required inspections in China for our BLA for toripalimab, timing of the end of our decline in revenues and timing of our ability to gain market share for any of our approved products, expectations about revenue growth, projections of expenses and revenue.

Our future manufacturing capacity and whether we can return to profitability and the timing of any return to profitability. All of these forward-looking statements involve substantial risks and uncertainties that are beyond our control and could cause actual results, performance or achievements to differ from those implied by the forward-looking statements. These statements are not guarantees of future performance and are subject to substantial risks and uncertainties 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. Fourth quarter and full year 2022 results are not necessarily indicative of results for 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.

Denny Lanfear
CEO, Coherus BioSciences

Thank you, Marek, thank you all for joining us on our Q4 2022 call. For Q4 2022, we continued our efforts to first drive top-line revenues across our products. Secondly, to actively manage expenses without jeopardizing our product launches or sales potential. Third, to drive towards profitability in 2024. Coherus' strategy is to create long-term shareholder value with immuno-oncology products that extend patient survival and to fund development of these products with the sales of biosimilars or other innovative products across diversified therapeutic areas. We have continued to make good progress with both our development efforts and our biosimilar sales efforts this quarter.

Following my opening remarks, Paul Reider, our Chief Commercial Officer, will update you on the CIMERLI launch and progress on obtaining our permanent reimbursement Q code, which we expect to drive sales starting in Q2 and on through 2023. Paul will then further update you on UDENYCA sales and trends for Q4 2022, as well as our plans for our newly approved UDENYCA autoinjector. As you know, the pegfilgrastim market has become increasingly more competitive, with market participants continuing to discount prices. As Paul will explain, our strategy is to provide multiple product presentations to fully address market needs, maximizing UDENYCA utilization. Dr. Theresa LaVallee, our Chief Development Officer, will update you on two key items. First, and most importantly, toripalimab inspections and approval, and secondly, ILT4 IND progress, as well as certain other pipeline developments.

With respect to clinical development, our Chief Medical Officer, Dr. Rosh Dias, will then update on recently announced final NPC data as well as progress on our TIGIT toripalimab combination study. As I indicated, we have been tightly focused on actively managing expenses without jeopardizing our product sales potential. Accordingly, McDavid Stilwell, our Chief Financial Officer, will provide greater detail on our expense management efforts. The top-line results of these exercises is that we are revising our previous 2023 SG&A expense forecast to $315 million-$335 million, a reduction for the 12 months of 2023 of nearly $100 million compared to previous guidance. This has been achieved by both reducing headcount by approximately 20% as well as realizing savings, including R&D across the board.

Last quarter, we told you that our goal was to launch four products or presentations by the end of 2023 and significantly reduce our cost structure. This quarter, we report that we continue to successfully track to those goals while adding yet another launch, our autoinjector presentation, UDENYCA. With that, I'll now turn the call over to Paul Reider, our Chief Commercial Officer. Paul?

Paul Reider
CCO, Coherus BioSciences

Thank you, Denny. I'll start with CIMERLI, the first and only interchangeable biosimilar to Lucentis, approved by the FDA with all five indications, both dosage strengths, and with 12 months of first interchangeability exclusivity. This complete label has been well received by retinal specialists, giving them the confidence that they can safely transition currently treated Lucentis patients to CIMERLI and expect the same clinical outcomes. Our strategic approach to the market is twofold. First, maximize the conversion of existing Lucentis business, which currently represents greater than 1 million units annually. Second, grow share through new patient starts or conversion from other anti-VEGF products.

For the fourth quarter, sales of CIMERLI were $7 million and market share ended the quarter at 2.4%, with channel inventory levels at the end of the quarter above the normal range due to launch stocking and anticipated demand. Payer coverage is expanding, which is creating greater access opportunities for CIMERLI. We have confirmed coverage on 100% of Medicare fee-for-service lives, enabling the reimbursement pathway for claims submitted under Medicare Part B, which is the majority of patients with wet AMD and 40% of Lucentis business. In addition, coverage achieved thus far for commercial and Medicare Advantage is 61% and 47% of lives respectively. Importantly, CIMERLI received its permanent product-specific Q code from CMS, which will go into effect on April 1st, providing retinal specialists more efficient electronic billing processes and faster reimbursement for submitted claims.

We see this as a catalyst for accelerated growth in 2023, beginning in Q2. Given this, we continue to expect that in 2023, CIMERLI revenues will be at least $100 million. I'll now turn to our oncology franchise, beginning with UDENYCA. For the fourth quarter, UDENYCA net sales were $38.3 million, which included a $4.7 million charge for a contingent liability related to resolving a dispute arising from certain sales, which occurred from October 2020 through December 2021. This compared to $45 million in the prior quarter. The majority of the decline was driven by, first, an 8% decline in demand, primarily in the clinic and non-340B segments, respectively. Secondly, a 14% decline in net selling price required to maintain a competitive position in the prefilled syringe segment.

Market share for the quarter was 12.4%, a 1% decline from the prior quarter. Channel inventory levels at the end of the quarter increased slightly above the normal range due to end-of-the-year holiday stocking at wholesalers. As Denny mentioned, we are excited to announce FDA approval of UDENYCA auto-injector, which represents the first product presentation innovation in the pegfilgrastim class in eight years. Commercial launch will occur in the coming weeks. UDENYCA will be the only pegfilgrastim brand with both prefilled syringe and auto-injector presentations, offering greater choice and flexibility for providers and patients, enabling them to tailor the pegfilgrastim treatment approach to their unique needs, whether it's in the clinic or at home. We believe that the UDENYCA auto-injector can effectively complete for Neulasta Onpro share in some of the clinical and patient settings.

This year, when we launch our on-body device, if approved, the UDENYCA brand will become the only pegfilgrastim product with three presentations, providing a total solution for customers and enabling UDENYCA to compete head-to-head with Neulasta Onpro, which currently maintains 44% of the market. Now regarding toripalimab. We remain excited about the potential to bring to oncologists and patients what would be the first and only PD-1 inhibitor approved in the U.S. indicated for nasopharyngeal carcinoma, and to establish a new standard of care in all lines of therapy, including first-line. Our oncology commercial capabilities have been built to scale, with significant overlap between UDENYCA customers and toripalimab-targeted prescribers. The launch of toripalimab will be efficiently integrated into our existing oncology commercial infrastructure.

We maintain a state of commercial launch readiness and will be ready to launch toripalimab directly upon FDA approval. I'll end with YUSIMRY, our Humira biosimilar, which is on track to launch in July. We continue to believe that price, supply robustness, and product presentation will serve as 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 autoinjector presentation, which was approved by FDA last month on schedule and 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 500,000 YUSIMRY units ready for distribution in July.

Despite the high competitive intensity of this market, we are confident that we will deliver a compelling YUSIMRY value proposition, and we'll share more details as we get closer to launch. I'll now turn the call over to Theresa.

Theresa LaVallee
CDO, Coherus BioSciences

Thank you, Paul. Good afternoon, everyone. I would like to begin with an update on our toripalimab inspections. As you know, the FDA missed the PDUFA date for our toripalimab NPC application in December of 2022. As we have previously noted, travel restrictions related to the COVID-19 pandemic have hindered the FDA's ability to complete inspections in China for the toripalimab BLA. As of January 8th, 2023, China's COVID policies were lifted, with complete elimination of the quarantine requirement upon entering the country or in response to a positive COVID test. Coherus and our partner, Junshi Biosciences, are currently engaged with the agency regarding the scheduling of the inspections. The FDA has notified the company of planned dates in the second quarter of 2023 for the manufacturing inspections in China.

The FDA granted toripalimab breakthrough therapy designation and has consistently recognized the unmet need for patients with NPC and the strength of the clinical data, which has been further supported by the positive final overall survival data. While we are very optimistic that the toripalimab will be approved for NPC, a rare cancer, an unmet need with no approved immunotherapy options in 2023. In 2022, the FDA made clear its position that it will generally require multi-regional clinical trials to support other US registrations that do not warrant regulatory flexibility. Consistent with the FDA's position, we have recently worked with our partner, Junshi, to streamline the toripalimab development plan and focus on the two studies that support the nasopharyngeal carcinoma BLA, as well as a small solid tumor study currently being conducted in the United States.

The development plan scope reduction significantly reduces our toripalimab-related clinical trial expenses going forward, as McDavid will describe later in the call. Toripalimab, a PD-1 with a differentiated mechanism of action and impressive survival benefit in multiple tumor types, provides an essential foundation to our IO pipeline. We continue to look at development opportunities to expand beyond NPC for toripalimab by investigating novel combinations with our partner, Junshi, with our TIGIT CHS-006 program with new partners that have clinical data and Coherus new molecular entities. With respect to our early-stage pipeline, CHS-1000, our proprietary ILT-4 antibody, a tumor microenvironment modulator, is progressing towards IND, and we are on track for filing in 2023. While the field has focused on T-cell checkpoint inhibitors, myeloid checkpoint inhibitors such as ILT-4 may serve as an important approach for overcoming PD-1 resistance.

We believe the mechanism of this myeloid modulator will be complementary with toripalimab and plan to explore the combination in a broad range of solid tumors, including lung cancer. I'll now turn it over to Dr. Rosh Dias to discuss the toripalimab combination studies in further detail.

Rosh Dias
CMO, Coherus BioSciences

Thanks very much, Theresa. Good afternoon, everyone. Toripalimab continues to form the backbone of our immuno-oncology franchise. We recently announced that we have positive final overall survival results of JUPITER-02 in nasopharyngeal carcinoma to build upon the positive PFS data published in Nature Medicine and presented at the 2021 ASCO Plenary Session and which we will be communicating in detail at a forthcoming congress. With regards to our TIGIT program, we remain excited about our toripalimab TIGIT study, which is currently active in the U.S., we're continuing to open U.S. sites. We anticipate data from this U.S. study being available beginning in 2024, as previously communicated, emerging data sets from the companion China toripalimab TIGIT study being available throughout 2023.

Finally, we continue to be active in exploring academic collaborations as well as partnership opportunities for toripalimab clinical trials with novel combinations across multiple tumor types, including non-small cell lung cancer. I'll now turn the call over to our Chief Financial Officer, McDavid Stilwell. McDavid?

McDavid Stilwell
CFO, Coherus BioSciences

Thank you, Rosh. The details of our financial results are in the press release, the 8-K and the Form 10-K we filed this afternoon, I'll focus on just a few highlights. For the fourth quarter and full year 2022, we reported net losses of $58.9 million and $291.8 million, respectively, on a GAAP basis. Net revenue for the fourth quarter was $45.4 million. UDENYCA net product revenue for the quarter was $38.3 million and was reduced by a $4.7 million charge for a contingent liability related to resolving a dispute regarding certain sales that occurred in 2020 and 2021. Net product revenue of CIMERLI, which launched October third, was $6.9 million. Cost of sales was $14.2 million for the quarter and $70.1 million for the year, resulting in gross margins of 69% and 67% respectively.

COGS for the full year 2022 included a $26 million write-down taken in the third quarter for inventory at risk of expiration. Recall that UDENYCA COGS includes a mid-single-digit royalty paid on net sales through midyear 2024, and CIMERLI COGS includes low to mid 50% royalties on gross profits. Research and development expenses were $29 million for the fourth quarter and $199.4 million for the year. Excluding upfront license fees in both years, R&D costs declined in 2022 relative to 2021 due to lower development expenses for UDENYCA and YUSIMRY. Selling, general, and administrative expenses were $53.6 million for the quarter and $198 million for the year.

An increase compared to the prior year that was driven by higher commercialization expenses in preparation for launches of CIMERLI in late 2022 and multiple new product launches in 2023, including toripalimab, YUSIMRY, and the autoinjector and on-body injector presentations of UDENYCA. We ended the year with $192 million in cash equivalents, and marketable securities. Looking ahead for 2023, we continue to project net product revenue to exceed $275 million, including at least $100 million in net sales of CIMERLI. In the last three months, we have implemented important measures to significantly reduce our operating expenses and cash outlays. As Theresa described, we have worked with our partner Junshi to streamline the U.S. toripalimab development plan, which forms the basis for our toripalimab-related clinical trial reimbursements.

We expect this change in scope will reduce our expenses for this asset by approximately $100 million over the next five years, including by $23 million this year in 2023. On our last call, we reported to you that we had reduced expenditures but would continue to work on generating more savings. I can report today that we are reducing headcount by about 20%, initiating a reduction in force impacting about 60 staff members effective March 10th. We have also reduced other internal and external SG&A expenses throughout the company. Additionally, we have worked with our manufacturing partners to reduce expenses and shift production schedules to minimize near-term cash outlays.

As a result of these measures, our projected operating expenses are significantly reduced compared to the five-year operating cost structure that we illustrated at our April 2022 Analyst Day event. For 2023, the difference is nearly $100 million. We project total combined SG&A and R&D GAAP operating expenses of $315 million-$335 million for this year, excluding upfront or milestone payments to collaborators and including approximately $50 million in non-cash stock compensation expense. As 2023 progresses, we expect our operating losses to moderate rapidly, and we continue to manage Coherus to become profitable again in 2024. I'll now turn the call to Denny for closing remarks.

Denny Lanfear
CEO, Coherus BioSciences

Thank you, McDavid, and thank you all for joining us on our Q4 2022 earnings call. We are pleased with our progress over the last quarter with the launch of our second product, CIMERLI, our Lucentis biosimilar. We're also pleased that we have obtained approval for a new and innovative product presentation, the UDENYCA autoinjector, which we'll launch next quarter addressing unmet patient and physician needs. Through thoughtful and disciplined cost and expense control, we have significantly reduced our 2023 expenses by about $100 million to about $325 million. We'll continue to look for more efficiencies and savings. In 2023, we look forward to the approval and launch of other products. We continue our efforts to drive revenue increases while controlling expenditures to achieve profitability in 2024. Operator, we're ready for the questions.

Operator

Thank you. As a reminder, to ask a question, you will need to press star one one on your telephone. Again, that's star one one on your telephone to ask a question. We ask that you limit yourself to one question and one follow-up, then return to the queue. Please stand by while we compile the Q&A roster. Our first question comes from the line of Salim Syed of Mizuho. Your question, please, Salim.

Salim Syed
Managing Director, Mizuho

Hey, great. Thanks so much for the question, guys. I guess, I'll use my one question on the auto-injector and my follow-up for Tori if I can. On the auto-injector, guys, can you just remind us, is the predominant. First, I guess, first, can you tell us when you filed this? I don't recall you guys actually ever telling us when you filed for the auto-injector. I'm just trying to understand how quickly the FDA may have gotten through this particular approval process. I'll just leave it there. I guess for my follow-up, just curious if you can give us an update on how you're pursuing NCCN coverage as a Category 2B drug for lung for toripalimab now that you have the inspection on the docket? Thank you.

Denny Lanfear
CEO, Coherus BioSciences

Yeah. Thanks, Salim. Actually, Salim, I would remind you that you detected the autoinjector clinical trial, some time ago. If I recall correctly. You also detected the on-body clinical trial at a similar timeframe. We have not disclosed the filing timing, but I'll let Dr. LaVallee make any further comments with respect to things. Theresa?

Theresa LaVallee
CDO, Coherus BioSciences

Yeah, thanks, Salim, for the question. For competitive reasons, we didn't talk about the autoinjector a lot. With the approval of BsUFA III , in terms of review timelines, it's dynamic, and it changed in October. I think the important thing is that we got the approval, this over the weekend. We're excited to see this launched and continue to develop the UDENYCA franchise.

Denny Lanfear
CEO, Coherus BioSciences

I think, before we have Rosh address the issue of NCCN, I would just invite Paul Reider to make some comments about where the autoinjector fits in to the product presentations that we're working on and the needs in the market. Paul?

Paul Reider
CCO, Coherus BioSciences

Sure. Hi, Salim. The market for pegfilgrastim since COVID has really bifurcated into two segments. You've got your prefilled syringe segment, which is around 55% of the business. That's where patients come back to the clinic or the office 24 hours after chemotherapy to get their injection. You've got the at-home segment, where patients will get the Onpro device supplied, and that is injected approximately 24 hours later. What became clear is that while the on-body device, you know, was very useful, it has certain restrictions and limitations. We believe that the autoinjector presentation will meet the needs of patients who desire an alternative to Onpro. These are patients that, you know, might be very active in their lifestyle and don't wanna wear a device, or they have had problems previously with the Onpro device.

You know, they just want more control over their treatment, where they can administer their pegfilgrastim injection when and where they want and not be in, you know, beholden to the timing of when the device is programmed to go off. We feel like this is gonna, you know, serve an unmet need for a number of patients, and we look forward to working with patients and doctor's office to bring this to market.

Denny Lanfear
CEO, Coherus BioSciences

Thanks, Paul. Rosh, can you address Salim's question regarding NCCN?

Rosh Dias
CMO, Coherus BioSciences

Sure. Salim, hi, and thanks for the question. Salim, we will obviously, first of all, wait for our NPC approval. Once that's happened, we can submit other published datasets to the NCCN. I'll remind you that we have, you know, we have published datasets in several high-tier journals. That's the timing in terms of NCCN.

Denny Lanfear
CEO, Coherus BioSciences

Did you have a follow-up, Salim?

Salim Syed
Managing Director, Mizuho

Oh, I thought I used it. I'll Out of respect for my peers, I'll get back in the queue. Thanks so much for the color, guys. Super helpful. Thank you.

Denny Lanfear
CEO, Coherus BioSciences

Okay.

Operator

Thank you. Our next question comes from the line of Douglas Tsao of H.C. Wainwright. Your question please, Douglas.

Douglas Tsao
Managing Director, H.C. Wainwright

Hi. Good afternoon. Can you hear me?

Denny Lanfear
CEO, Coherus BioSciences

Yep.

Douglas Tsao
Managing Director, H.C. Wainwright

Maybe as a starting point with CIMERLI, Paul, your Q code will come into effect on April 1st. Just curious from your perspective, how meaningful will that be, and will it sort of really unlock a lot of that value, or will it continue to build throughout the year, or should we see a really big step up in, you know, with the start of Q2 and with the Q code being available?

Paul Reider
CCO, Coherus BioSciences

Thanks, Doug. The Q code is really important because under this miscellaneous code period, retinal specialists have to manually submit claims, the processing of the claims is manual, which delays reimbursement, and it increases financial risk to the practice. Retinal specialists, you know, trying to manage cash flow, understand this. What the product-specific Q code will do is it will enable efficient electronic billing processing. It'll automate the reimbursement for the claims, minimizing the risk of error and the claims denial. We're working with many practices now to begin to operationalize that with their billing systems, electronics, health record systems. We think it's gonna be the catalyst for growth in 2023, starting in Q2. Obviously, it will build as the year goes on.

Douglas Tsao
Managing Director, H.C. Wainwright

Okay. Obviously with, you know, one of the big events for the year, Denny, is the launch of YUSIMRY in July. Just curious, at what point will you start to have visibility and be able to share with us where that product is positioned from a formulary standpoint with payers? 'Cause I know you've always said that that's gonna be a big part of the strategy. Thank you.

Denny Lanfear
CEO, Coherus BioSciences

Yeah. Thanks, Doug. Fair question. I think that it's fair to say that the Humira biosimilar, you know, formulary environment is in a dynamic period at this point with Amgen launching and so on. I think that we will have clarity on this sometime after the July launch. I would say that the Q3, the post Q3 call when we get to that, which should be around November, would be a great time to talk about how things are panning out and what's going on. I think that is fairly dynamic, as you know, for this year in 23. Perhaps things will settle out a little more in 24. I don't think we'll know very much until we see what happens in Q3 and how things are shaking out. Fair question, though.

Douglas Tsao
Managing Director, H.C. Wainwright

Okay, great. Thank you.

Operator

Thank you. Our next question comes from the line of Chris Schott of JP Morgan. Please go ahead, Chris.

Chris Schott
Managing Director, JPMorgan

Great, very much. Just two questions for me. Just continuing on the biosimilar Humira front, just to help set our expectations, do you see there being a meaningful revenue opportunity for this product in 2023? Or is the opportunity more skewed to 2024 and beyond, given some of the contracting that AbbVie's put in place? I'm just trying to get a sense of, is this year more about formulary building and access versus actual revenue, and next year is more the revenue opportunity? My follow-up question was just on the cost savings front. I think you mentioned toripalimab and some streamlining of the programs there, but can you just elaborate a little bit more about where the other expense reduction is coming from?

Just trying to get my hands around how much of this is savings on the SG&A side versus further deferred R&D, and just getting a little bit more color of how you're kind of streamlining the business. Thanks so much.

Denny Lanfear
CEO, Coherus BioSciences

Hey, Chris. Thanks for the question. With respect to Humira biosimilar's projected revenues for 2023 and 2024, as I indicated a little earlier, with Doug, I don't think we'll really have a good grip on that until we get past the July launch. We see what happens, you know, how the jockeying with the positioning of the formularies goes and so on. You know, I don't wanna give you imprecise information or gaze into the crystal ball here, without basis. I think we'll just have to wait post-launch and see how things pan out. I think that's a totally fair question to ask us on the November call with respect to Q, you know, Q3, and so on.

With respect to the savings and where the savings came from, I'll let McDavid Stilwell handle that. I think that we have done a very complete job looking top to bottom on the organization in a number of areas for savings. McDavid, where are the key areas the savings came from for Chris's benefit?

McDavid Stilwell
CFO, Coherus BioSciences

Thanks, Chris. The expense reductions come across three main areas, headquarters headcount, development expenses, and manufacturing expenses. We're rethinking business processes across the company and asking how can we operate more efficiently. The toripalimab joint development committee reducing the scope of the U.S. development plan from a broad development plan to the three studies that Theresa described, that's also very significant in the overall expense reduction. Finally, with respect to manufacturing, we are shifting the timing of certain manufacturing-related expenses and inventory building, in order to reduce expenses near term. What we are not doing is we are not significantly downsizing the customer-facing teams for UDENYCA or CIMERLI.

We don't expect that the workforce reduction, will impact our ability to, you know, to execute on our commercial plans and meet our revenue targets.

Denny Lanfear
CEO, Coherus BioSciences

One thing with respect to the how we have approached this on the commercial side, and maybe Paul Reider can comment a little further, is we're multiplexing these groups across both products. For example, you know, the market access group that addresses the payers, right? We have those folks working on CIMERLI plus UDENYCA plus potentially toripalimab and so forth. The other area is also the internal operations group, the data analytics group. They also get multiplexed across these various products. We have additional bandwidth for even more products actually. I think that we found good efficiencies there, and I think Paul's team is really working much in a very much an integrated holistic sort of fashion. Paul, any particular comments on this?

Paul Reider
CCO, Coherus BioSciences

No, I would just reinforce that, you know, when we built the commercial team, we built it to scale, and it was designed so that, you know, the multiple groups handle the portfolio. Then he mentioned the payer team, our field reimbursement managers, and importantly, our key accounts and strategic account teams, you know, that handle the big accounts for both oncology and retina. They're dealing with the same GPO groups and others. And so this, this provides us tremendous synergies in not having to add additional layers of groups. So we are taking every advantage of those synergies in the launch of our products, managing headcount and capacity very carefully. But we feel we're very right-sized to be able to continue our multiple launches here in 2023.

Chris Schott
Managing Director, JPMorgan

Thanks, Paul.

Paul Reider
CCO, Coherus BioSciences

Thank you.

Operator

Thank you. Our next question comes from the line of Balaji Prasad of Barclays. Your line is open, Balaji.

Speaker 13

Hi. Good afternoon. This is Xiao on for Balaji. Thanks for taking our question. Just one quick one on the generalizability issue and toripalimab. Seems like for the indication for NPC, seems like you don't have any concerns for generalizability. Is it because the patient profile of NPC patients would help addressing the generalizability issue? Is it because there is currently no approved targeted therapy for NPC in the United States? Thank you.

Denny Lanfear
CEO, Coherus BioSciences

Oh, thanks for the question. Theresa, could you address the generalizability of the data question, please?

Theresa LaVallee
CDO, Coherus BioSciences

Yes. Thanks, Balaji. Both points are important. Both the epidemiology of the disease, but also critically, that there are no approved immunotherapies in the disease. It's both the. It's a rare disease. The FDA has always looked at rare disease populations and the ability to do multi-regional versus targeted trials as an approach to really look at a drug's effect. The overall survival impact that has been observed is quite compelling. It's a risk benefit that is undeniable.

Speaker 13

Thank you. This is very helpful.

Operator

Thank you. Our next question comes from the line of Jason Gerberry of Bank of America. Please go ahead, Jason.

Jason Gerberry
Managing Director, Bank of America

Hey, guys. Thank you for taking my questions. So my question is just around the OpEx cuts if they're in any way related to any and be anticipated shortfall on revenue from the new launches in 2023 or 2024. My follow-up on Salim's question is about NCCN and lung. Do you think the toripalimab could garner much use in lung cancer, just on an NCCN recommendation? Metro precedent you point to that, mindful that you're obviously not promoting for there, but, you know, I think with an NCCN recommendation, doctors can get reimbursement technically. Just kind of curious about that dynamic.

Denny Lanfear
CEO, Coherus BioSciences

Hi. Thanks. I'll take the first one with respect to the revenues, and then I'll let Rosh Dias, our CMO, address the NCCN. No, not so much a shortfall in revenues driving the cuts, but we felt that we needed to have the organization highly focused and right-sized, and we felt that it was prudent for us and responsible to look for savings across the organization. We talked about this last year and developed savings in Q3 and Q4, which we disclosed. We told you we're gonna go out and look for some more, and we've gone ahead, and we've done that. We run a very, I think, efficient company, a very tight ship. All the expenditures are very closely scrutinized, and we know what each single person in the company is doing and how they work together. We think it's prudent.

Lastly, I would say that, as I've said to you many times, we are very focused on driving towards profitability in 2024. That means two things. That means, first of all, bringing up the revenue line with the additional products, CIMERLI, UDENYCA, the additional presentations, Tori, YUSIMRY, all across the board. Raise the revenues and really control the cost without jeopardizing those revenues. When those two lines intersect, we get the profitability. That's really our focus. With respect to NCCN, I'll let Rosh address that question. Rosh?

Rosh Dias
CMO, Coherus BioSciences

Hi, Jason. Thanks. Yeah, as I mentioned before, to Salim, you know, again, we will wait for NPC approval. After that happens, we are able to submit additional datasets. You asked specifically about lung. Lung was published, I think back in the August timeframe in JCO. Once we have NPC approval, we will go ahead and submit and see.

Jason Gerberry
Managing Director, Bank of America

Got it. Thanks.

Operator

Thank you. Our next question comes from the line of Ashish Verma of UBS. Please go ahead, Ash.

Ash Verma
Equity Research Analyst, UBS

Hi. Thanks for taking my questions. I have two. On the UDENYCA autoinjector, just curious, like, trying to understand how simple is this to use? Would this require kind of like any training for patient, physician? How do you foresee most of the initial use to happen? Would it be in the physician office setting, or do you think patients can actually use this? The second one, we've seen, like, 1 biosimilar Humira competitor launch, and they have 2 product offerings. Does that in any way change your view in terms of either how pricing could evolve in this market or whether companies like yourself would want to have 2 product strategy to come into the market? Thanks.

Denny Lanfear
CEO, Coherus BioSciences

Hi, Ash. Thanks, thanks for the question. If I understand you correctly, the first question is, what about the autoinjector, the AI ease of use and so on. Second is, with respect to our Humira biosimilar and so on. I'll let Paul answer both these, but I would first presage remarks by saying that we're very proud of the autoinjector. Very streamlined. It's an excellent autoinjector. We had a lot of experience with autoinjectors because of the Humira product, which also has an excellent autoinjector. I believe it's a two-step autoinjector. Paul, a little more backstory on that for us.

Paul Reider
CCO, Coherus BioSciences

Sure. Yeah, Ash, this is a, this is a state-of-the-art autoinjector. There's no buttons to it. It's a push-to-skin activation. Really, it just, it's the patient can depress it onto their body. It's a very reliable device, delivering the dose consistently, and it's fast. You know, the whole process start to finish can take under 10 seconds, which gives, again, the patient a lot of control, over when and where they can do it. We'll have training devices, but really it's so simple to use, really anybody can learn how to do it. And if they don't, when we launch our on-body device later this year, we'll be the only brand that offers doctors and patients three different presentations to meet their unique needs.

We would imagine that the autoinjector will be used both in the office, you know, for nurses who prefer this over a prefilled syringe. There's no needle exposed, so that's a real advantage, or at home. We're expecting usage in both settings of care. With respect to, the biosimilar launch of Amgen's product, you know, we're not gonna comment at this time, you know, on our pricing strategy. I think you'll learn more about that once we, you know, are closer or right after launch, Ash.

Denny Lanfear
CEO, Coherus BioSciences

I would just add with respect to YUSIMRY that, you know, we engaged with the market significantly the last few years on what was important to folks, what's important to the . That is, you know, robust supply, citrate free, pain-free formulation, small needle, high patient comfort, strong price, supply guarantees. We really focus there, and that's the value proposition that we're gonna bring to the market, and we think we're gonna compete well with that.

Ash Verma
Equity Research Analyst, UBS

Thank you.

Operator

Thank you. I would now like to turn the conference back to Denny Lanfear for closing remarks. Sir.

Denny Lanfear
CEO, Coherus BioSciences

Thank you, operator. Thank you all for joining us on our Q4 2022 call. As you can see, Coherus continues to progress against its goals of developing our IO franchise, plus launching additional products to support their development. We have also been quite busy with respect to constraining our expenses and making sure the company operates very efficiently. We look forward to Q2 when we get a little more lift with the CIMERLI sales on the Q code, and we'll be happy to chat with you all again in August, when you see how things come out for Q2. Thank you.

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.

Denny Lanfear
CEO, Coherus BioSciences

Thank you, operator.

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