Good day, and thank you for standing by. Welcome to the Coherus BioSciences, Inc. First Quarter 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 on your telephone. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, McDavid Stilwell, Chief Financial Officer. Please go ahead. Thank you, operator. Good afternoon, everyone, and thank you for joining us. We issued a press release earlier announcing our financial results for the first quarter of 2022, and the release can be found on the Coherus BioSciences website. 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 advance our product candidates through development and registration, the status of our product candidate clinical profile, our timing and ability to commercialize our products and product candidates in the future, our R&D and SG&A expense guidance for 2022, our revenue targets for 2026 and our ability to meet the same, our projections about margin, as well as our ability to draw down amounts under our recent credit facility, and the timing of the resubmission and review of the toripalimab BLA. All these future events involve substantial risks and uncertainties that are beyond our control and could cause actual results, performance, or achievements to differ from the results, performance, or achievements 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 Securities and Exchange Commission, including those in our quarterly report on Form 10-Q with today's date. The 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. With me on today's call are Dennis Lanfear, CEO of Coherus, Paul Reider, Chief Commercial Officer, Theresa LaVallee, Chief Development Officer, and Dr. Rosh Dias, Chief Medical Officer. I'll now turn the call to Dennis. Thank you, McDavid Stilwell. Good afternoon, everyone, and thank you for joining us today on our conference call to review recent business highlights and financial results for the first quarter of 2022. Today, we'll provide updates on our current business, as well as our progress transforming Coherus into an innovative immuno-oncology company, supported by revenues from a diversified portfolio of FDA-approved products. Now first, with respect to the complete response letter we received from the FDA pursuant to the toripalimab BLA for advanced nasopharyngeal cancer, we are currently assembling the FDA meeting package, which will support an agency interaction to occur prior to the BLA submission. We expect mid-summer filing in the six-month review timeline. As we previously communicated, we believe the requested quality process change is straightforward and readily addressable. Further to the development side of the business, Dr. Theresa LaVallee, our Chief Development Officer, will provide additional detail regarding toripalimab BLA, as well as our work with our partner, Junshi Biosciences, on the development of toripalimab for other indications, and in combination with CHS-006, our targeted antibody. On the commercial side of the business, Paul Reider, our Chief Commercial Officer, will review recent UDENYCA performance and our preparation for the anticipated near-term commercial launches of, first, toripalimab, which we plan to launch for NPC once approved. Similarly, on the CIMERLI biosimilar candidate, where review of the BLA is proceeding well and progressing towards an August 2, 2022 action date. YUSIMRY, our Humira biosimilar, where we are investing heavily in inventory build as robust supply availability is a key part of our market strategy. As well as UDENYCA on-body injector presentation, significant market share growth opportunity for our UDENYCA franchise. Today, we're also announcing the termination of our license relationship with Innovent for the development of the biosimilar Avastin candidate, IBI-305. COVID commenced shortly after execution of this agreement and has caused significant delays to the development timeline. We have recently assessed the market dynamics, and given ongoing and projected COVID-related delays, we determined that this program no longer warrants our continued investment. Lastly, McDavid Stilwell, the company's Chief Financial Officer, will review our first quarter financial results and provide an update on our operating expense guidance for the remainder of 2022. We'll then, of course, be happy to take your questions. Now today, I want to introduce you to our new Chief Medical Officer, Dr. Rosh Dias, who is with us and will be happy to take your questions during the Q&A. Rosh has over 18 years experience in oncology across medical affairs, development, and commercialization. We welcome Rosh to our team. Now, at our Analyst Day event, March twenty-ninth, we introduced 2026 revenue guidance targets of $1.2 billion-$2.2 billion, and further described how we will leverage our existing operational infrastructure to achieve our commercial and development objectives. With continued strong execution of regulatory approvals and commercial launches and the advancement of our novel immuno-oncology pipeline, we expect to transform Coherus into a rapidly growing, profitable, and innovative immuno-oncology company. Now I'll turn the call over to Dr. LaVallee for an update on the toripalimab BLA review and our other development programs. Theresa. Thank you, Denny. As Denny referenced, the FDA issued a complete response letter for the biologics license application for toripalimab for NPC. The CRL requests a quality process change that we believe is straightforward and readily addressable. We plan to meet with the FDA to ensure our resubmission is complete and will submit the meeting request package in the next few days. We plan to resubmit the BLA by mid-summer 2022. The agency also communicated in the CRL that the review timeline for the BLA resubmission would be six months. As required, on-site inspections have been hindered by travel restrictions related to the COVID-19 pandemic in China. The FDA has indicated that the existing toripalimab clinical data are supportive of the BLA submission. Toripalimab has demonstrated clinical efficacy in multiple tumor types, including in tumors with low PD-L1 expression. This differentiated clinical activity may result from toripalimab's high binding affinity to a unique epitope that potentiates PD-1 internalization. The next clinical milestone for toripalimab will be the readout of the PFS and OS co-primary endpoints from the small cell lung cancer study, JUPITER-8, which is expected this year. We recently obtained orphan drug designation for this indication in the United States. JUPITER-8 is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial evaluating platinum chemotherapy plus etoposide alone or in combination with toripalimab as the first-line treatment of extensive stage small cell lung cancer. This is an aggressive tumor characterized by rapid disease progression, low expression of PD-L1, and low levels of tumor-infiltrating immune cells, as well as a high degree of immunosuppression. Efficacy of cancer immunotherapy has been limited in small cell lung cancer, and no PD-1 inhibitors are currently approved in the United States for this indication. Regarding additional potential indications in the United States, we announced at our recent Analyst Day event that we are working with Junshi to review possibilities to amend protocols of several studies to enroll patients in the United States to satisfy the FDA's needs for multi-regional clinical trials. We look forward to providing additional information on this topic in the future. At this time, we are not planning additional studies for toripalimab in combination with chemotherapy for first-line non-small cell lung cancer. However, we are planning to develop the dual IO treatment of toripalimab in combination with our TIGIT, CHS-006 for non-small cell lung cancer, leveraging the robust efficacy results reported in the CHOICE-01 study. An ongoing phase I clinical trial evaluating CHS-006 and toripalimab is being conducted in China and is expected to read out next year. An IND is open in the U.S., and we expect to begin enrolling cohorts of U.S. patients later this year or early next year. Blockage of the TIGIT pathway may be a crucial underlying mechanism for overcoming PD-1 resistance. We believe the dual immunotherapy approach of TIGIT with PD-1 could enhance PD-1 efficacy with the potential to extend survival and create a new standard of care for multiple tumor types. We expect to see important clinical data from several competing TIGIT programs in coming months, and these data may inform the future direction of our CHS-006 development program. At our recent Analyst Day, we introduced several wholly owned programs targeting ILT-4 and CCR8 that are being developed by Coherus scientists at our research center in Camarillo. We expect to submit an IND for our first of these, CHS-1000, targeting ILT-4 next year and to file at least one new IND per year going forward. On the biosimilar development and regulatory front, we recently held the late cycle review meeting with the FDA for the CIMERLI BLA, and that review is advancing towards the August action date. Upcoming in June, results of the PK/PD study evaluating our UDENYCA on-body injector device will be published in connection with the ASCO annual meeting. Recall that we previously announced that the study met all PK bioequivalence primary endpoints, as well as the key secondary pharmacodynamic endpoint of ANC. I'll now turn the call to Paul Reider. Thank you, Theresa. UDENYCA net sales were $60 million the first quarter, a decline from $73.4 million the prior quarter. This was driven by a 12% decline in demand units, as well as continued price erosion due to intense competitive pressures in the pegfilgrastim prefilled syringe market. On a units basis, the overall pegfilgrastim market increased 1% in the first quarter, and we expect low single-digit market growth in the remainder of 2022, consistent with historical trends. Neulasta retains 59% total market share within the class, with Onpro holding 47% market share based on an entrenched preference by customers reinforced by the COVID pandemic. UDENYCA market share erosion from 17.5% to 16% in the first quarter occurred largely in the hospital segment, where competitive biosimilars have resorted to a strategy of offering irreversible significant price reductions in order to capture short-term market share. This is reflected in the quarterly ASP declines by these competitive products. With our on-body device in the pipeline, our strategy is to maintain a disciplined approach in managing price with the PFS format in 2022. This will enable us to maximize long-term revenues for the UDENYCA franchise through significant share gains that we expect in 2023 and beyond within the on-body segment, which currently represents approximately $1 billion in untapped opportunity. We expect UDENYCA market share to grow next year once we introduce our UDENYCA on-body injector, if approved. Now I'd like to talk about commercializing our pipelines. We are preparing for the launch of three new brands in the next 15 months. Toripalimab, our PD-1 inhibitor for nasopharyngeal carcinoma, CIMERLI, our Lucentis biosimilar, and YUSIMRY, our Humira biosimilar. Nasopharyngeal carcinoma, or NPC, is a rare cancer where there are currently no PD-1 inhibitors approved for use by the FDA. Toripalimab not only has the potential to be the first and only PD-1 inhibitor indicated for this tumor type, but also to establish a new first-line standard of care. Our oncology commercial capabilities have been built to scale and there is significant overlap between our current UDENYCA customers and Toripalimab-targeted prescribers. Therefore, the launch of Toripalimab will be efficiently integrated into our existing oncology commercial infrastructure. In addition, the NCCN Guidelines Committee for NPC has added as a reference to the guidelines the citation for the JUPITER-02 trial, which was published in Nature Medicine last year, further validating the importance and quality of the clinical trial. Commercial launch preparations are on track and the field-facing teams have been fully trained. We will be ready to launch toripalimab if approved by FDA. With respect to CIMERLI, our FDA action date is August 2, 2022, which, if approved, will allow us to launch in the early biosimilar market formation period of the $7 billion anti-VEGF market. This is a clinic-based buy and bill model, which is very similar to oncology and a core competency of ours, and we look forward to competing in this large, attractive market. Recently conducted market research confirms the opportunity exists to penetrate the entire VEGF market. Since our last call, we've continued to engage with retina thought leaders, built out additional marketing expertise, and hired the head of our ophthalmology sales team, an experienced sales executive with over 15 years building and leading sales teams in the ophthalmology therapeutic area. Retina specialist opinion leaders expressed positive receptivity to Coherus entering this market, and our track record of success in oncology gives them confidence that Coherus understands the dynamics of a buy and bill market and that we will deliver a safe and effective alternative to Lucentis with a compelling value proposition. Now regarding YUSIMRY, our Humira biosimilar. YUSIMRY was approved by FDA last December, and we are preparing for a launch in July 2023. Humira's US net sales were $17 billion in 2021, and we look forward to competing in this large market. We believe payers and PBMs will drive biosimilar adalimumab adoption and have completed extensive market research with national and regional payers as well as PBMs. The insights gleaned from this market research confirm that Coherus can deliver on the attributes most important to payers, which include a highly competitive price, robust and reliable supply, and an auto-injector presentation that has non-stinging citrate-free formulation. YUSIMRY will have both a pre-filled syringe and an auto-injector presentation, and the YUSIMRY device will include our proprietary non-stinging citrate-free formulation and a 29-gauge needle, all comparable to the originators. We also plan to introduce a high concentration presentation post-launch. To meet our expectations to win at least 10% unit market share, we have invested more than $45 million in large-scale manufacturing and expect to be a high volume, low-cost manufacturer, well-positioned to compete on supply guarantees and price. Our first-year manufacturing capacity exceeds 1 million units, or about 10% of the overall adalimumab market, and we have the potential to triple that capacity in the current facility. Unlike other players in the adalimumab market, we have no portfolio of branded alternatives to Humira that we need to protect from adalimumab cannibalization. Our positioning for YUSIMRY is perfectly aligned with that of the payers and PBMs. We want to make the adalimumab market as large as possible as quickly as possible. We see this as a source of competitive advantage. In short, we are confident that we will deliver a compelling value proposition and that we can achieve our objective to win at least 10% unit market share at peak. I'll now turn the call to McDavid for a review of the quarter's financial results. Thanks, Paul. I'll focus on just a few financial highlights since the details are in the press release and in the 10-Q that we filed earlier this afternoon. For the first quarter of 2022, we reported a $96.1 million net loss on a GAAP basis. On a non-GAAP basis, we reported a net loss of $77 million. GAAP to non-GAAP reconciliation included two items, $12.9 million in non-cash stock-based compensation expense and a $6.2 million loss on the extinguishment of debt. Cash used in operating activities was $54 million for the first quarter of 2022. As detailed earlier in the call, net product revenues were $60.1 million, a decline from the prior quarter and the year ago quarter. The decline was primarily attributable to a decline in demand units, as well as lower net realized price. Research and development expenses for the first quarter of 2022 were $82.9 million, compared to $203.5 million for the same period in 2021. This year's first quarter included a $35 million payment to Junshi Biosciences for the license of CHS-006, our TIGIT-targeted antibody. Last year's first quarter R&D expense included the $145 million upfront payment to Junshi for the toripalimab collaboration. Selling, general, and administrative expenses were $48.8 million in the first quarter of 2022, as compared to $39.4 million in the year ago quarter. The increase was primarily driven by activities in preparation for the launches of multiple new commercial products anticipated in 2022 and 2023. We ended the quarter with cash and cash equivalents of $326 million compared to a balance of $417 million at year-end 2021. Recall that in January, we entered into a credit facility agreement with Pharmakon Advisors for a $300 million term loan payable across four tranches. We drew the first $100 million tranche at closing and simultaneously paid off a $75 million term loan. At the end of March, we drew a second $100 million tranche and simultaneously paid off the 2022 convertible notes. Two additional tranches of $50 million each will become available to us upon the approval by the FDA of toripalimab and of CIMERLI. As for our expectations for full-year operating expenses, with the discontinuation of the CHS-305 Avastin biosimilar program and the delay in the toripalimab launch, we are lowering our projected range for full-year R&D and SG&A expenses by $20 million to $395 million-$430 million. This guidance excludes both the $35 million upfront fee to Junshi Biosciences that we paid for rights to CHS-006 and the $25 million milestone payment that will become due on approval of toripalimab for nasopharyngeal carcinoma. This range also includes approximately $55 million-$60 million in non-cash stock-based compensation expense. Let me provide some additional color on these anticipated operating expenses, a significant portion of which is investment that will convert back to cash quickly with a high IRR. This year, we will spend approximately $50 million manufacturing inventory for new product launches. Recall that one lesson from our UDENYCA launch is that going to market with ample supply is a critical success factor. Also, recall that low-cost inventory manufactured and expensed prior to approval subsequently is expected to deliver P&L benefit in the form of lower cost of goods sold. Another $40 million-$50 million of operating expense this year will fund completion of development of additional presentations of products we expect to introduce over the next two years, as well as manufacturing scale-up projects that will deliver ongoing benefits in the form of significantly lower costs. I'll close by saying that on the investor relations front, we'll be participating in the Bank of America Healthcare conference in Las Vegas next week on May 12, and in the UBS conference in New York on May 24, and the HCW conference in Miami on May 25. I'll now turn the call to Denny for closing remarks. Thank you, McDavid, and thank you all once again for joining us today. This is an exciting time in our company as we prepare for as many as four product launches in 2022 and 2023, and continue to make strong progress transforming Coherus into an innovative immuno-oncology company, supported by our diversified commercial portfolio revenues. With our sharp focus on execution of this strategic transformation, the leveraging of our commercial capabilities with new products, and the advancement of our novel immuno-oncology pipeline while keeping a critical eye on our cost structure, I believe we are in excellent position to create significant shareholder value in the coming years. Operator, we're ready to take any questions. Thank you. As a reminder, to ask a question, you will need to press star one on your telephone. To withdraw the question, press the pound key. Please stand by while we compile the Q&A roster. Your first question will come from the line of Salim Syed with Mizuho. Please proceed with your question. Hi. Hi, guys. This is Bennett on for Salim. Thanks for taking our questions. Regarding toripalimab submissions beyond NPC, are you still planning to submit for ESCC and non-small cell lung cancer this year? Or should we expect this to happen after potential first approval in nasopharyngeal? A lso, if you could provide a little more color based on the Hi. I'm sorry. Let's just do one question at a time. Sure. Then we'll provide you with the opportunity for a follow-on question. I'll let Dr. Theresa LaVallee address the question about the submissions. Did you hear the question clearly? Mm-hmm. Salim, hi. Thanks for the question. Just to make sure I heard, you were asking about submission for non-small cell lung cancer. Is that correct? For ESCC as well, if you're planning to do it this year as well, or you know, are you gonna expect first to get approval in NPC? As mentioned during the discussion, we don't anticipate following up with toripalimab in non-small cell lung cancer for a filing based on the CHOICE-01 data. We'll leverage that data to look at dual immunotherapy combinations with and our target molecule CHS-006. In terms of other filings, I think at this time we're focused on engaging with the FDA on NPC, and we'll continue to have discussions about where else the clinical data really warrant regulatory flexibility. We'll be happy to provide you with the opportunity for a follow-on question then. Did you have a second one? Yeah, thank you. Well, if you could provide a little bit more color on the reasons behind today's announced discontinuation of CHS-305? Thanks. Could you provide more color on the discontinuation of CHS-305? Yes, we're happy to of course. First of all, let me say that we have a very positive relationship with Innovent. I have a very good relationship with their Innovent CEO, Michael Yu. We signed this agreement, and directly thereafter, right after Chinese New Year, as you can recall, COVID struck. COVID basically impaired the progress of this product development, I think significantly. It was very difficult, and it was impossible actually for us to travel to China. The clinical trials were difficult and a number of things. We lost a substantial amount of time, with the product really as a function of that. When we took a look during a product review period, currently it was simply a matter that the commercial case for the product and the market had moved on from our prior assumptions. Given the costs that were at hand in front of us, we felt that it was in the best interest strategically for us to discontinue it. There's really nothing more to it. Again, we have nothing but good things to say about our friends at Innovent and, it's unfortunate that this particular product cannot move forward, but it was simply a business decision. Sounds good. Thank you very much. Thank you. Your next question will come from the line of Balaji Prasad with Barclays. Please proceed with your questions. Hi. Good evening, and just a couple of questions from my side. Firstly on FDA inspections, are there any pending for either CIMERLI or YUSIMRY? I'll stick to one question. Thanks. Yeah. Theresa, do you wanna answer that one then with respect to CIMERLI inspections? Yeah. We feel that we're complete at this time. I'm sorry, complete for both of them? Yeah. T he CIMERLI inspections have been completed, and there's no issues impairing the approval. And YUSIMRY I'm sorry, summary. UDENYCA is approved. YUSIMRY is already approved. Of course, my bad. Yep. Thanks. Your next question will come from the line of Jason Gerberry with Bank of America. Please proceed with your question. Hey, guys. Thanks for taking my questions. I guess my first would just be looking at the run rate that you have for UDENYCA right now, 1Q. Do you see any reason why that would get better for the remainder of the year before you have the OBI launch, which will be a 2023 event? Just curious, do you see that run rate improving? I know there was some commentary about, I think, sort of market unit volume trends, you know, growing, but I'm just curious specifically your own run rate, how that pans out through the rest of the year. Well, I thank Jason for that. Paul, do you want to take that one? Thanks for your question, Jason. Yeah, as we indicated during our Q4 call, you know, where we stated that our UDENYCA sales in 2022 will be less than the sales in 2021, we're not offering any updates to that guidance at this time. T he market grew 1%, remaining relatively stable. We're expecting that to pick up. But that's where we're at right now. No further updates on guidance. Okay. Then I guess if I can get a follow-up question, just based on the commentary about sort of the maybe irrational competitor pricing behaviors in the UDENYCA market, thinking ahead to Humira, just given the sheer volume of players, do you see this as a profitable market beyond 2024? Like, I think most people could probably say 2023 and 2024 could be interesting, but there's sort of an expectation among the investors that perhaps pricing could get so compressed in that category that it might be not particularly profitable beyond 2024. Curious if you guys have a view there based on your learnings from the UDENYCA, I guess, market launch. I would let Paul add some additional remarks, but I would point to two things. First of all, we've already made previous investments that we outlined in order to be the high volume, low-cost producer. We've made significant progress in driving the cost down with fully loaded and released auto-injector, which I think the price will be significantly larger than. The second issue though, I think is Paul might wanna go ahead and address. Yeah, no, I think Denny articulated very well, Jason. There's a two-pronged approach to success, you know, with the adalimumab biosimilar entry. It's price and it's supply. You know, we're gonna be coming to market, offering supply guarantees, and we'll react to whatever price is gonna be in the market at that particular time. We're very prepared to compete on that price to gain rapid adoption on the formularies, in the second half of 2023, with real acceleration occurring in 2024 and beyond. We see the opportunity for significant revenue growth in this market. Yeah. We expect with our cost structure to remain profitable for a number of years on this product, given our high volume and low cost capabilities, Jason. The fact that we don't expect it. We also don't expect to build a sales force. Yep. Okay, guys. Thanks. Thank you. Your next question will come from the line of Georgi Yordanov with Cowen and Company. Please proceed with your questions. Hey, guys. Thank you so much for taking our questions. I guess for the first one, regarding the review process for biosimilar Lucentis, are there any additional updates or color you could provide around interactions with the agency? Specifically, have you been part of these discussions? Has your partner received clearance around the manufacturing issue that was identified in the previous CRL? If I could have a follow-up. To be clear, and I'll let Dr. LaVallee address this in more detail too. To be clear, yes, we are confident that the previous issues with respect to the manufacturing CRL have been fully addressed. There has been an inspection of the facility and the manufacturing inspection we do not believe are any impediment to approval whatsoever. Theresa, do you have any additional comment with respect to UDENYCA approval? Yeah, we just completed the late cycle meeting, and I am optimistic of continuing engagement with the FDA through the review process for the August PDUFA date. Great. Just around the opportunity for biosimilar Lucentis. Do you know if there are any other competitors except Biogen and Samsung that might be launching in the near term? Given that limited competition, could you potentially see a similar ramp up as we saw with UDENYCA over the next 2 to 3 years? Well, I would say that our understanding is Biogen will probably be in a position of coming to market before us. Just how much we're uncertain, but perhaps a bit. As you point out, we were second to market with UDENYCA. Did very, very well with that launch, with that product and dominated that biosimilar market, up until this point. I think that we're fairly optimistic about how well Paul and his team will perform with the CIMERLI launch, based on our demonstrated expertise. Paul, any additional points you wanna make on CIMERLI for the launch? I don't think so, Denny. I think, I mean, we're in the market formation period, and that's key for, you know, short- and long-term success with biosimilar. We're gonna be prepared to come in at that market formation period with our track record of our expertise and, you know, clinic-based buy and bill markets with our expertise, you know, with contracting with discipline there, as well as ASP management and delivering a retinal specialist a very compelling value proposition. Yep. Just one note. The first sBLA filing did not receive a complete response letter. There was additional manufacturing data requested by the agency. That data was subsequently developed in conjunction with the agency they conferred with. It was submitted, it was accepted, and now we look forward to approval. Thank you so much. At this time, there are no further questions in queue. I would now like to turn it back over to the panel for closing remarks. Thank you, operator, and thank you everybody for joining us today. This concludes today's conference call. Thank you for participating. You may now disconnect.