Coherus Oncology, Inc.

Good day and thank you for standing by. Welcome to the third quarter 2021 Coherus Biosciences conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, McDavid Stilwell. Please go ahead.

Thank you.

Good afternoon, everyone, and thank you for joining us. We issued a press release earlier announcing our 2021 third quarter results. This release can be found on the CoHARIS Biosciences website. Today's call includes forward-looking statements regarding CoHARIS's current expectations. These statements include but are not limited to our ability to advance our biosimilar and immuno-oncology product candidates through development and registration, our commercialization of Eudinica and other potential products in the future, our ability to meet our R&D and SG&A expense guidance for 2021, as well as our uses of capital, all of which involve certain assumptions, risks, and uncertainties that are beyond our control and could cause actual results to differ from these statements. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are discussed in documents that we file with the Securities and Exchange Commission, specifically in our quarterly report on Form 10-Q for the quarter ended September 30th, 2021 that we filed earlier this afternoon. The forward-looking statements stated today are made as of this date and we undertake no duty to update such information except as required under applicable model. With me on today's call are Denny Lanphier, CEO of Coherus, Paul Reeder, Executive Vice President of Commercial Operations and Market Access, and Chris Thompson, Executive Vice President of Sales. I will now turn the call over to Denny. Thank you, McDavid, and thank you all for joining us this afternoon. I'm pleased today to report on our recent achievement of key milestones driving near-term growth of our commercial product portfolio. We now have three PLAs under FDA review and expect to pursue multiple additional FDA applications. In 2022, based on recently reported positive clinical data, we expect within a year to have four products approved and within two years to have five products launched and driving significant revenue growth. to fund our expansion in oncology. Since our last conference call in August, we've reported a series of significant achievements towards this goal. First, the positive data from the Udentica On-Body Injector Clinical Trial, which is expected to enable a 2022 submission of a prior approval supplement to the Udentica BLA. Following the 10-month review period for the OBI submission, we plan to launch directly upon approval. The FDA has accepted the BLA for our biosimilar leucensis, CHS201, and has signed a target action date of August 2022. We plan to launch directly upon approval. The FDA review of the BLA for our biosimilar hemyra, CHS1420, is proceeding well and advancing toward the December 2021 action date. We plan to launch in July 2023. The FDA also accepted the toropalimab BLA for advanced nasopharyngeal carcinoma, including in combination with chemotherapy for first-line and as monotherapy for second-line and greater, and granted priority review with a target action date of April 2022. We plan to launch toropalimab directly upon approval next year. Recently presented positive data from the esophageal squamous cell carcinoma Phase III clinical trial are expected to enable the submission of a toropalimab BLA supplement in 2022. Positive progression-free survival data from the Phase III clinical trials evaluating toropalimab and non-small cell lung cancer were presented in September. Final PFS and interim overall survival data are expected by early first quarter 2022, after which Coheris and partner Junichi Biosciences