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Coherus Oncology, Inc.
3/6/2023
Thank you for standing by, and welcome to Caheris 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 1-1 on your telephone. I would now like to hand the call over to SVP, Investor Relations, Mark Chachefsky. Please go ahead.
Thank you, Lateef, 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 Coherence Biosciences website and is also attached to our Form 8K. Today's call includes forward-looking statements regarding Coherence'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 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 Danny Lanphier, CEO of Claharis, Dr. Therese Hellevalley, Chief Development Officer, Dr. Rosh Diaz, Chief Medical Officer, Paul Reeder, Chief Commercial Officer, and McDavid Stilwell, Chief Financial Officer. I will now turn the call over to Danny.
Thank you, Merrick, and 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. And then third, to drive towards profitability in 2024. COHER's strategy is to create long-term shareholder value with immuno-oncology products that extend patient survival and the 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 Reeder, 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 Udenica sales and trends for Q4-22, as well as our plans for our newly approved Udenica auto injector. As you know, the Pegtoe Grasta 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 UDENICA utilization. Dr. Theresa Lavallee, our Chief Development Officer, will update you on two key items. First, and most importantly, Tor Palamab 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. Raj Dias, will then update on recently announced final NPC data, as well as progress in our tiget-torpalimab 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 is being 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 auto injector presentation in Udenica. With that, I'll now turn the call over to Paul Reeder, our Chief Commercial Officer. Paul?
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