Coherus Oncology, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the Coherus Biosciences 2019 Fourth Quarter Earnings Conference Call. My name is May, and I will be your conference operator for the call today. At this time, all participants are in a listen-only mode, and as a reminder, this conference call is being recorded. I would now like to turn the call over to David Arrington, Vice President of Investor Relations and Corporate Affairs. Please go ahead.

Thank you, May, and good afternoon, everyone. After close of market today, we issued a press release on our fourth quarter and year-end financial results. This release can be found on the Coherus Biosciences website. Joining me for today's call will be Denny Lanfear, Coherus' CEO, Dr. Jean Barret, Chief Financial Officer, Vince Anicetti, Chief Operating Officer, and Thomas Fitzpatrick, Chief Legal Officer. Before we begin our formal remarks, I would like to remind you that we will be making forward-looking statements with respect to product development plans all of which involve certain assumptions, risks, and uncertainties that are beyond our control and could cause actual results to differ from these statements. A description of these risks can be found on our most recent filings with the SEC. In addition, Coherus Biosciences does not undertake any obligation to update any forward-looking statements made during the call. I will now turn the call over to Denny.

Thank you, David, and welcome, everyone, to our Q4 earnings call. Today we will cover four broad areas for you. First of all, I'll review the performance of Udenica, both Q4 2019 and the entire year, with which, of course, we're very pleased. Secondly, we'll review the progress on our pipeline, including both our wholly owned internally developed assets, as well as our in-license products. And we will provide you an update with respect to our thinking on our CHS131 small molecule. Following that, I'll make a few remarks about the company's further transaction efforts for 2020 before handing it off to our Chief Financial Officer, Jean Verret, who will review our financial performance for the quarter and the year. First, with respect to the company's commercial performance of Udenica, we are very pleased we've met our goal of achieving 20% or more market share by the end of 2019, as guided in our Q2 earnings call last year. These market share gains were achieved across all segments, 340B hospitals, non-340B hospitals, clinics, and against both pre-filled syringe and on-body injector formats. During 2019, we made substantial progress with both our national and regional payers, achieving over 95% access for Udenica patients. We believe this performance validates our overarching commercial strategy as conceived prior to launch with our focus on branded biologics positioning, robust guaranteed supply, comprehensive patient support services such as Coheres Complete, as well as individualized contracting to support biosimilar conversion, all in the context of ASP pricing discipline to preserve long-term value. During 2020, you will see the company's commercial efforts continue in a highly integrated and effective manner, to pursue additional market share gains. Now let me make a few remarks with respect to our pipeline. One year after launch, the success of Udenica has validated our biosimilar business model. As a result, our pipeline strategy is now focused on leveraging our R&D and commercial strengths in selected therapeutic areas that can provide the greatest value to patients and the healthcare system while also generating the best return for our shareholders. Let me first discuss the company's ophthalmology franchise. With respect to our Lucentis Biosimilar in license from BioAg, we are currently focused on supporting our partner to generate the additional manufacturing data as requested by FDA and expect to resubmit the application upon completion of these efforts and certain regulatory interactions. With respect to our CHS 2020 ILEA Biosimilar, we are very pleased with our progress and are now in position to initiate commercial-scale GMP manufacturing efforts in support of the expected Phase III clinical trials in 2021 with launch projected in 2025. As we have previously discussed, these products will compete in a $6 billion anti-VGF U.S. market with favorable order of entry and competitive dynamics. Optimology is reimbursed under the buy-and-bill model, a reimbursement dynamic in which we have demonstrated proficiency in biosimilar market conversion, delivering greater patient access and healthcare system savings. Now, with respect to our immunology franchise and CHS 1420, our hemoglobin biosimilar, over the past year and a quarter, we have held a series of type 3 meetings with FDA and have now gained concurrence with FDA on the analytical and clinical strategy in support of a BLA-filing in the second half of 2020. We've also made good progress with the further development of our manufacturing strategy for this product in preparing for a large-scale launch in mid-2023. As we have discussed previously, we believe this will be an $18 billion market in the US prior to our launch, and we expect to take our fair share of that market as we leverage our biosimilar commercial infrastructure. Now, as mentioned, We are now focused on oncology, ophthalmology, and inflammation. We have determined that CHS-131, our small molecule program currently in development with NASH, while highly valuable, does not align with the company's strategic priorities, and thus we plan to pursue strategic alternatives for this asset. We believe that focusing on our core biosimilar business in these key therapeutic areas is in the best interest of generating shareholder value. Thank you, Danny. I will now review the main financial results for our full year and fourth quarter 2019. First,