Coherus Oncology, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Coherius Biosciences 2019 Second Quarter Earnings Conference Call. My name is Lady 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, ladies, and good afternoon, everyone. After close of market today, we issued a press release on our second quarter financial results. This release can be found on the Coherus Biosciences website. Joining me for today's call will be Dennis Lanfear, Coherus CEO, Dr. Jean Bourret, Chief Financial Officer, Jim Hazard, Senior Vice President of Marketing and Market Access, 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 this call. I will now turn the call over to Denny.

Thank you, David. Good morning, and thank all of you for joining us today. As you know, Udenica experienced strong uptake in the first quarter, and we are pleased to report today that launch performance through the second quarter remains very strong. Our second quarter performance is the direct result of our strong execution across all key customer segments of what is now a well-validated biosimilar-specific strategy. Udenica sales are growing with significant momentum through the first half of the year, providing a solid foundation for continued growth for the second half of 2019 and beyond. In a few moments, our Senior Vice President of Marketing and Market Access, Jim Hazard, will provide you with additional context on the drivers behind this performance to help you better understand the potential sustainability of our market conversion efforts. First half results also demonstrate that the company is well positioned to deliver on the long-sought promise of biosimilars for patients, providers, and payers, while creating value for our shareholders. We believe this is true for the current portfolio of Udenica, anti-TNF, and ophthalmology biosimilars, as well as any additional products that we may commercialize in the medium to long term. Now, following Jim's remarks, our Chief Financial Officer, Dr. Jean Marais, will review the financial results, including details on gross sales and net sales proportions, as well as making some brief comments with respect to using secondary data sources as a proxy for net product sales. Lastly, John will comment on what we feel is a significant milestone for the company, that is the achievement of profitability. After John's remarks, I will provide you with a summary of today's key points and guidance on expected unit market share for the rest of 2019 and beyond before we go to the Q&A. Now the last two quarters have been exceptional, defining what constitutes a successful biosimilar commercialization and establishing Udenica Launch as the benchmark for future biosimilars. We think the key for being successful in the biosimilar business is to be a biosimilar company. So we don't think it is a coincidence that the most successful biosimilar launch to date was executed by a company solely focused on the biosimilar opportunity. Udenica Net Sales in the first half of 2019 were approximately $120 million, supported by a strong exit unit market share of about 13% at the end of June. Now, this market share gain has been realized against both on-pro and pre-filled syringe formats and in all segments of the market, validating our broad and deep launch strategy. Further, these results give us confidence to project continued market unit share increases for the remainder of 2019 and through 2020. The successful launch is the result of our significant preparation and strong execution. On previous calls, we outlined the investments we made in the years prior to launch, and no substantial investments have set the stage for the success of what we see today. Now I'll let Jim review in greater detail the execution enabled by these investments. Jim?