Coherus Oncology, Inc.

Welcome to the Q1 2021 CoHarris Biosciences, Inc. Earnings Conference Call. My name is Richard, and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. During the question-and-answer session, if you have a question, please press star, then 1 on your touch-tone phone. I will now return the caller to McDavid Stilwell, Chief Financial Officer. Mr. Stilwell, you may begin.

Thank you.

Good afternoon, everyone, and thank you for joining us. We issued a press release earlier announcing our 2021 first 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 Eugenica 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 10Q for the quarter ended March 31st, 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 today are Cohera CEO, Denny Lanphier, Paul Reeder, Executive Vice President of Commercial Operations and Market Access, Chris Thompson, Executive Vice President of Sales, and Dr. Shah Rahimian, Senior Vice President of Immuno-Oncology Clinical Development. I'll now turn the call over to Denny. Thank you, McDavid, and thank you all for joining us this afternoon. Today I'll provide updates on Udenica commercialization our biosimilar pipeline candidates, as well as Toropalimab, the PD-1 antibody we in-licensed from Junshi Biosciences earlier in the first quarter. We are making strong progress with Toropalimab and our biosimilar product candidates. Over the next two years, we anticipate bringing four new products to market in the United States, complementing Udenica in our commercial portfolio. The investments we are making in 2021 are expected to diversify and grow our revenues for years to come. With the clinical data and regulatory milestones over the next 12 months, we expect the key elements to come together in our unique strategy of leveraging the strong cash flows from our biosimilar products into the rapidly growing immuno-oncology market. Today I'll start with a review of the performance of our first product, Eugenica, which maintains its position as the most prescribed type of grass and biosimilar with 20% of the overall market as reported by IQVIA. In the first quarter of 2021, we recorded $83 million in net sales of Udenica, as compared to $110 million in the fourth quarter of 2020, and $116 million in the year-ago quarter. Market share for Udenica at 20% was relatively flat compared with the fourth quarter, and within the 20% to 22% range we have experienced since the start of the COVID pandemic. The overall Pegfell Braston market grew by 1%. in the first quarter. Quarter-over-quarter revenue decline for Udenica in Q1 was driven primarily by two factors, inventory changes and pricing. First, seasonal fluctuations in wholesale inventory had a significant impact on quarter-to-quarter ex-factory shipments. Wholesale inventory rose from 11 days on hand at the end of the third quarter 2020 to 21 days on hand in the fourth quarter and then came back down at the end of the first quarter to 12 days. Second, as we have signaled since the third quarter last year, pricing pressure has intensified across the Pikeville-Graston market. The ASPs reported by CMS show the trends across the category. Price declines have been most significant for the originator, Elasta, which now has the lowest ASP at any Pikeville-Graston. I'd now like to introduce Paul Reeder, our Executive Vice President of Commercial Operations and Market Access. Paul brings over 30 years of relevant commercial experience in oncology and other therapeutic areas to Coheris and will provide some additional color to the market dynamics we see going forward. Paul?