Coherus Oncology, Inc.

Good day, and thank you for standing by. Welcome to the Quarter 2 2021 Cujarros Conference Call. At this time, all participants are in a listen-only mode. If you require any further assistance, please press star zero. To ask a question, you will need to press star one on your telephone. I would now like to hand the conference over to your speaker today, Matt David Stilwell, Chief Financial Officer. Please go ahead, sir.

Thank you. Good afternoon, everyone, and thank you for joining us. We issued a press release earlier announcing our 2021 second quarter results. This release can be found on the CoHarris Biosciences website. Today's call includes forward-looking statements regarding CoHarris' 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 Udenica 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 involves 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 10Q for the quarter ended June 30, 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 law. With me on today's call are Denny Lamphere, CEO of Coheris, Paul Reeder, EVP of Commercial Operations and Market Access, and Chris Thompson, Executive Vice President of Sales. And I will now turn the call over to Denny.

Thanks, McDavid, and thank you all for joining us this afternoon. Today, I'll provide updates on eugenic performance, our biosimilar pipeline, and progress with Torapalmab, our PD-1 antibody. We're pleased with our progress as we transform Coheris from a single-product biosimilar company to a diversified multi-product biopharma company with multiple oncology assets. Over the next two years, we anticipate bringing four new products to market in the United States, complementing Udenica. Our diversified product portfolio will generate growing and durable cash flows to invest in the large and rapidly developing immuno-oncology market, but Toro Pedal Math is our foundational asset. Now let me first turn to Udenica. In the second quarter of 2021, we recorded $88 million in net sales of Udenica as compared to $83 million in the first quarter. Udenica market share, as reported by Acuvia, declined a point quarter-to-quarter from 20% to a 19% share. Wholesaler inventory was stable in the second quarter compared to the prior quarter end and was not a factor in second quarter revenues. Recall the first quarter revenue was negatively impacted by the burn-off for about nine days of wholesaler inventory that accumulated the seasonal buy-ins at year-end 2020. Later in the call, Paul Reeder will provide additional details with respect to our expectations for the second half Udenica performance. Now let me update you on the excellent progress we're making with our biosimilar pipeline. Together with Udenica, our biosimilars of Lucentis, Humira, and Abastin ADDRESS AN AGGREGATE 28 BILLION IN MARKET OPPORTUNITY. WE'VE ALREADY DEMONSTRATED OUR ABILITY TO USE OUR BRANDED MARKETING AND COMMERCIAL CAPABILITIES TO PENETRATE COMPETITIVE AREAS WITH BIOSIMILAR. WE BELIEVE WE'LL EXPERIENCE SIMILAR SUCCESS TAKING SIGNIFICANT SHARE IN THESE NEW BIOSIMILAR MARKETS. OUR OBJECTIVE IS TO TAKE AT LEAST 10% OF EACH OF THESE NEW MARKETS AND IN SOME CASES, AS WITH EUDENICA, EVEN GREATER MARKET SHARE. Our next expected biosimilar launch is CHS-201, our Lucentis biosimilar candidate. I'm pleased to report that our partner, BioAct, recently submitted the BLA to the FDA. Assuming the filing is accepted for review, we anticipate a standard 12-month review and approval cycle. We are excited about the potential approval of this product in 2022 and believe it will be among the first biosimilar Lucentis candidates to market, actively participating in market formation Launch planning is underway. Now, with respect to our Humira biosimilar CHS1420, the FDA review is progressing well, and we believe that the application is on track for December 2021 target date. You may recall that we expect to launch CHS1420 in the United States on or after July 1, 2023. Regarding CHS305, our Avastin biosimilar, we are currently conducting a three-way PK study to support BLA. which we expect to file in the first part of 2022. Once approved, the Avastin commercial opportunity will further leverage our commercial oncology capabilities with nearly identical customer base as Udenica and Toropalimab, adding incremental margin to our bottom line. Now, let me make a few remarks with respect to Toropalimab and provide you with a positive update regarding our BLA filing in nasal pharyngeal carcinoma, or NPC. As you may recall, the registration strategy called for filing the second and third line MPC BLA, and then post approval, filing a supplemental BLA for first line treatment events. FDA has now agreed to accept the first line submission for concurrent evaluation with the second and third line data, thereby accelerating time to potential approval for the first line indication. Jupiter-2, the clinical trial evaluating toropalamin for first line MPC, generated strong progression-free survival and overall survival data that were presented this June in the plenary session at ASCA. The rolling BLA submission for all MPC indications is expected to be completed this quarter, and we continue to project approval in the first half of 2022. Now, I'm also pleased to report that to our PALMAP clinical data will be presented in September at two medical conferences. Data from the Phase III first-line non-small-cell lung cancer study which we earlier reported had met the primary endpoint of progression-free survival, will be presented at the World Conference on Lung Cancer. The Jupiter VI Phase III study in esophageal squamous cell carcinoma, which also met its co-primary endpoints of progression-free and overall survival, will be featured at the annual meeting of the European Society for Medical Oncology. Junshi continues to make good progress with additional chloropalamin clinical trials in lung cancer, which represents approximately 45% of the PD-1 market opportunity. Phase III studies evaluating toropelmab and neoadjuvant at small cell lung cancer and EGFR positive patients who have failed TKI treatment are enrolling rapidly with data expected next year. Phase III study in small cell lung cancer with co-primary endpoints of progression-free and overall survival is now fully enrolled and is also expected to read out 2022. You'll find details of these studies on slide 20 of the August industrial presentation, which we posted to our website earlier today. Beyond lung cancer, in 2022, we also project data from a phase 3 study and first-line treatment of triple negative breast cancer and two phase 3 trials in hepatocellular carcinoma, one for the first-line treatment and one in the neoadjuvant setting, as detailed on slide 21 of the investor presentation. Torpalmab is the foundation of our immuno-oncology franchise, and developing it in combination with other agents that can improve response rates is a key part of our strategy. JS006, the digit antibody for which we have option rights, is now being evaluated by Jun Shi at phase one clinical trial and is progressing well. I'll now turn the call over to Paul Reeder, our Executive Vice President of Commercial Operations and Market Access, for some additional color on the market dynamics we see going forward for Udenica. Paul?