Thank you for standing by, and welcome to Coherus Biosciences Fourth Quarter and Fiscal Year 2022 Earnings Conference Call. [Operator Instructions] I would now like to hand the call over to SVP, Investor Relations, Marek Ciszewski. Please go ahead.

Thank you, Latif, and 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' 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 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. 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.

Thank you, Marek, and thank you all for joining us on our Q4 2022 call. For Q4 '22, 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. And then 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 the fund development 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 similarly 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 '22, as well as our plans for our newly approved UDENYCA auto injector. 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 MPC data as well as progress in 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. However, the top line results of these exercises is that we are revising our previous 2023 SG&A expense forecast to $315 million to $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 of our auto injector presentation UDENYCA. With that, I will now turn the call over to Paul Reider, our Chief Commercial Officer. Paul?

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. And 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, similarly received its permanent product specific Q-code from CMS, which will go into effect on April 1 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…

Thank you, Paul, and good afternoon, everyone. I would like to begin with an update on our Toripalimab inspections. As you know, the FDA midst the PDUFA date for our Toripalimab MPC 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. However, as of January 8, 2023, China's COVID policies were listed with complete elimination of the quarantine requirement upon entering the country or in response to a positive COVID tests. Coherus and our partners Junshi Biosciences are currently engaged with the agency regarding the scheduling of the inspection. 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 MPC 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 MPC of rare cancer an unmet need with no approved immunotherapy options in 2023. The FDA in 2022, the FDA made clear its position that it will generally require multi-regional clinical trials to support other U.S. registration 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 reductions significantly reduces our Toripalimab related clinical trial expenses going forward as McDavid will describe later in the call. Toripalimab, a PD1 with a differentiated mechanism of action and impressive survival benefit in multiple tumor types provides an essential foundation to our I-O pipeline. We continue to look at development opportunities to expand beyond MPC 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 are proprietary ILT4 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 ILT4 may serve as an important approach for overcoming PD1 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.

Thanks very much, Theresa, and 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 the forthcoming Congress. With regards to our TIGIT program, we remain excited about our Toripalimab TIGIT study which is currently active in the U.S. and we're continuing to open U.S. sites. We anticipate data from this U.S. study being available beginning in 2024 as previously communicated and emerging datasets from the Companion China Toripalimab TIGIT study being available throughout 2023. And 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?

Thank you, Rosh. The details of our financial results are in the press release, the 8-K, and the 10-K we filed this afternoon, so 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 $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 3, 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 exploration. Recall that UDENYCA COGS includes a mid-single-digit royalty paid on net sales through mid-year 2024 and similarly 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. It 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 auto injector and on-body injector presentations of UDENYCA. We ended the year with $192 million in cash, cash equivalents, and marketable securities. Looking ahead…

Thank you, McDavid, and thank you all for joining us on our Q4 2022 earnings call. We are pleased with our progress in 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, UDENYCA auto injector which will launch next quarter addressing the 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 and we'll continue to look for more efficiencies in savings. In 2023, we look forward to the approval and launch of other products and we continue our efforts to drive revenue increases while controlling the expenditures to achieve profitability in 2024. Operator, we're ready for the questions.

[Operator Instructions] Our first question comes from the line of Salim Syed of Mizuho. Your question please, Salim?

Thanks so much for the question, guys. I guess I'll use my one question on the auto injector and my follow-up for if I can. On the autoinjector, 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 every time as when you filed for the autoinjector. I'm just trying to understand how quickly the FDA may have gotten through this particular approval process? I'll just leave it there. And then 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 TB drug for lung for Toripalimab now that you have the inspection on the docket? Thank you.

Yes. Thanks, Salim. Actually, Salim, I want to remind you that you detected the auto injector clinical trial some time ago, if I recall. If I recall correctly, and 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. Yes, Theresa?

Yes, thanks Salim for that question. For competitive reasons, we didn't talk about the auto injector a lot and with the approval of [indiscernible] in terms of review timelines, it's dynamic and it changed in October. So I think the important thing is that we got the approval this over the weekend. So we're excited to see this launched, and continue to get to develop the UDENYCA franchise.

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

Sure. Hi Salim. So the market for pegfilgrastim since COVID has really bifurcated into two segments. You've got your pre-filled 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. And then you've got the at home segment where the 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, it was very useful. It has certain restrictions and limitations. And we believe that the auto injector presentation will meet the needs of patients who desire an alternative to Onpro and these are patients that might be very active in their lifestyle, don't want to wear a device, where they have had problems previously with the Onpro device or they just want more control over their treatment where they can administer their pegfilgrastim injection when and where they want and not be beholden to the timing of when the device is program to go off. So we feel like this is going to serve an unmet need for a number of patients, and we look forward to working with patients and doctors' office to bring this to market.

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

Sure. Salim, hi, and thanks for the questions. So Salim, we will obviously first of all, wait for our NPC approval and once that's happened, we can submit other published data sets to the NCCN and I'll remind you that we have - we've published data sets in several high tier journal. So that's the timing in terms of NCCN.

Did you have a follow up, Salim?

No. I thought you used that. I'll respect from my peers, I'll get back in the queue, but thanks so much for the color, guys, and super helpful. Thank you.

Okay.

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

Maybe as a starting point with CIMERLI, Paul, the - your Q-code will come into effect on April 1. Just curious from your perspective, how meaningful will that be and we sort of really unlock a lot of that value or will it continue to build throughout the year or should we feel really big step up in with the start of 2Q and with the Q-code being available?

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

Okay. And obviously, with 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 be able to share with us where that product is positioned from a formulary standpoint with payers because I know you've always said that that's going to be a big part of the strategy? Thank you.

Yes. Thanks, Doug. Fair question. So I think that it's fair to say that the Humira biosimilar formulary environment is in a dynamic period at this point with Amgen launching and so on, and I think that we will have clarity on this sometime after the July launch. So I would say that the Q3, the post Q3 call, when we get to that, which should be around November will be a great time to talk about how things are panning out and what's going on. But I think that is fairly dynamic. As you know, for this year and '23 press things will settle out little more in '24, but 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.

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

Just two questions from me. Just continue on the biosimilar Humira front, just 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 '24 and beyond given some of the contracting that AbbVie has put in place? I was trying to a sense of, is this year more about can like formulary building and access versus actual revenue and next year is more of a revenue opportunity? And then my follow-up question was just on the cost savings front. I think you mentioned Tori and some streamlining of the programs there. But can you just elaborate a little bit more about where the other expense reductions coming from? 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 kind of streamlining the business? Thanks so much.

Chris, thanks for the question. With respect to Humira biosimilar's projected revenues for '23 and '24, 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 and how the jacking with the positioning of the formularies goes and so on. So I don't want to give you imprecise information. Our case has a crystal ball here without basis. So I think we'll just have to wait post launch and see how things pan out, but I think that's a totally fair question to ask us on the November call with respect to Q3 and so on. With respect to the savings and where the savings came from, I'll let McDavid Stilwell handle that. But I think that we have done a very complete job looking towards the bottom on the organization in a number of areas for savings. McDavid, were the key areas to savings came from for Chris' answer.

Sure. Thanks, Chris. The expense reductions come across three main areas; headquarters' headcount, development expenses, and manufacturing expenses. So we're rethinking business processes across the company and asking how can we operate more efficiently. And then the Toripalimab joint development committee reducing the scope for 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. And then 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. We have - what we're not doing is we're not significantly downsizing the customer-facing teams for UDENYCA or CIMERLI. And so we don't expect that the workforce reduction will impact our ability to execute on our commercial plans and meet our revenue targets.

One thing with respect to the - how we have approached this on the commercial side and maybe Paul Reider can comp a little further is we're multi flexing these groups across both products, for example, the market access group that addresses the payers, right? We have those folks working on CIMERLI plus UDENYCA plus potentially Toripalimab and so forth. And the other area is also the internal operations group, the Data Analytics Group, they also get multiplex across these various products. We have additional bandwidth for even more products actually. But I think that we found good efficiencies there and I think Paul's team is really working much, very much an integrated holistic sort of fashion. Paul, any particular comments on this?

No, I would just reinforce that when we built the commercial team, we built it to scale and it was designed so that the multiple groups handle the portfolio. Denny mentioned the payer team. Our field reimbursement managers and importantly, our key accounts and strategic account teams that handle the big accounts for both oncology and retina. They're dealing with the same GPO groups and others. And so, this provides us tremendous synergies and not having to add additional layers of groups. So we are taking advantage of those synergies and 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.

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

This is a [Nishal] on for Balaji. Thanks for taking our questions. Just one quick one on the general stability issue and Toripalimab. Things like for the indication of NPC, it seems like you don't have any concerns for general liability. So is it because the patient profile of NPC patients would help addressing the general ability issue or is it because there is currently no approved targeted therapy for NPC in the United States? Thank you.

Thanks for the question. Theresa, could you address the generalized ability of the data question, please?

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

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

Thank you for taking my questions. So, my question is just around the OpEx cuts there in any way related to any and be anticipated shortfall on revenue from the new launches in 2023 or 2024. And then my follow-up on Salim's question is about NCCN and lung. Do you think the Toripalimab could garner much it's in lung cancer? I just saw an NCCN recommendation. I'm not sure as they precedent two point here that mindful that you're obviously not promoting for there. But I think with NCCN recommendation doctors can get reimbursement technically. So just kind of curious about that dynamic?

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 revenue is driving the cost, 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 going to go on and look for some more and we've gone ahead and we've done that. We run a very I think efficient company 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. So we think it's prudent. And lastly, I would say that, as I've said to you many times, we are very focused on driving towards profitability in 2024 and 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 costs without jeopardizing those revenues. And when those two lines intersect, we get the profitability. So that's really our focus. With respect to NCCN, I'll let Rosh address that question. Rosh?

Hi, Jason. Thanks. As I mentioned before to Salim, again we will wait for NPC approval. And then after that happens, we are able to submit additional data set. You asked specifically about lung was published I think back in the August timeframe in JCO. So once we have NPC approval, we will go ahead and submit and then see.

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

Hi, thanks for taking my questions. I have two. So on the UDENYCA autoinjector injector, 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 used to happen. Would it be in the physician office setting or do you think patients can actually use this? And the second one, so we've seen like one biosimilar Humira competitor launch and they have two product offerings. Does that in anyway change your view in terms of either how pricing could evolve in this market or whether companies like yourselves would want to have two product strategy to come into the market? Thanks.

Hi, Ash. Thanks. Thanks for the question. So if I understand you correctly, the first question is what about the autoinjector AI ease of use and so on. And second is with respect to our Humira biosimilar and so on. I would first I'll let Paul answer both, but I would first pre-stage remarks by saying that we're very proud of the auto injector, very streamlined, it's an excellent auto injector. We had a lot of experience of auto injectors, because of the Humira product, which also has an excellent autoinjector. I believe it's a two-step auto injector and then Paul, little more back story on that for us?

Sure. Yes, Ash, this is - a this is state-of-the-art auto injector. There's no buttons to it, it's a push to skin activation. So really it's just - it's the patient can press it onto their body. It's a very reliable device delivering the dose consistently and it's fast. 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 will 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 auto injector will be used both in the office for nurses who prefer this over a prefilled syringe, there is no needle exposed. So that's a real advantage or at home. So we're expecting usage of both settings of care. With respect to the biosimilar launch of Amgen's product, we're not going to comment at this time on our pricing strategy. So I think you'll learn more about that once we are closer or right after launch, Ash.

Yes, I would just add with respect to YUSIMRY that we engaged with the market significantly last few years and what was important to folks what's important to those. And that is robust supply citrate free pain free formulation, small needle high patient comfort, strong price supply guarantees. So we really focused there and that's the value proposition that we're going to bring to the market and we think we're going to compete well with that.

Thank you.

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

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 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 and the Q-code and we'll be happy to chat with you all again in August when you see how things come up for Q2. Thank you.

This concludes today's conference call. Thank you for participating. You may now disconnect. End of Q&A:

Thank you, operator.