Coherus Oncology, Inc.

Good day, and thank you for standing by. Welcome to the Q3 2024 Coherus Biosciences Earnings 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 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Jody Sievers, Head of Investor Relations. Please go ahead.

Thank you, Daniel. Good afternoon, and welcome to Coherus Biosciences' third quarter 2024 earnings conference call. Joining me today to discuss our results are Denny Lamphere, Chief Executive Officer of Coherus, Brian McMichael, Chief Financial Officer, Paul Reeder, Chief Commercial Officer. Dr. Rosh Dias, Chief Medical Officer. And Dr. Theresa LaValley, Chief Development Officer. Before we get started, I'd like to remind you that today's call includes forward-looking statements regarding Coheris' current expectations about future events. These statements include, but are not limited to, the following. Expectations for the time that it will take for our labeling and packaging CMO to resume packaging of Udenica. and projections about the timing and number of units that it will complete, projections about the timing and number of units that may be completed by our additional labeling and packaging CMO, and projections about future revenues, market share, and expenses. All of these forward-looking statements involve substantial risks and uncertainties that are beyond our control and could cause actual results, performance, or achievements to differ from those implied by the forward-looking statements. These statements are not guarantees of future performance and are subject to substantial risks and uncertainties, including risks and uncertainties inherent in our manufacturing process and our reliance on third parties that are discussed in our press release that we issued today, as well as the documents that we file with the SEC. Forward-looking statements provided on the call today are made as of this date And we undertake no duty to update or revise any forward-looking statements. And now, I'll turn the call over to Denny.

Thank you, Jodi. Good afternoon, everyone, and thank you for joining us today on the call. Today, we're pleased to share updates from the third quarter of 2024. Nine months into the year, we continue to first make good progress towards advancing innovative next-generation therapies with the potential to extend cancer patient survival. And secondly, execute well against our four-part strategy to deliver long-term shareholder value, specifically to drive top-line growth, control operating expenses, advance our pipeline, and improve our capital structure. While we have done well across each of these four dimensions, we are particularly pleased with the sales performance of the Udenica franchise through the third quarter, so I will focus there first. Significantly, Eudetica has achieved 100% revenue growth since Q3 2023, reaching $66 million in revenue this quarter. This includes a 30% increase from Q2 to Q3 this year as our franchise kicked into high gear, demonstrating that our three presentation franchise options, and it's the on-body, the auto-injector, and the pre-filled syringe, is working very well. and delivering exceptional value to customers. Also in Q3, Udenica retained its number two position in the market with nearly 30% share. We expect Udenica to return to market growth in 2025. Now let me address the Udenica supply interruption in our overall supply chain strategy for just a moment. I'm happy to report to you that based on the updated production schedule, our labeling and packaging contract manufacturing organization is resuming final packaging of Udentica this week. While this is a few weeks later than previously targeted, it's important to note that now that the CMO is restarting, they plan to process all 13 backlog lots without further interruption or delay. This comprises about 120,000 Udentica units, representing several months worth of supply. which are expected to be completed over the next five weeks. This will allow us to restock the distribution channels as fast as possible, as we expect to ship these final product lots as they are completed, making sure they get to our customers in an expedited fashion. Now that we have the schedule, we have started working with our channel partners and customers to understand and model how the restocking exercise will impact Q4 sales and the uptake dynamics. Since that effort is just now starting, we do not have a Q4 sales estimate for you today, but plan to provide one in early January. We've also made significant progress bringing an additional labeling and packaging CMO online in order to expand and further diversify our supply chain. Setup and test lots have been completed. Qualification of manufacturing is underway, and the requisite regulatory discussions are ongoing. Saleable lots are planned to start manufacturing in December, and once the product from this operation is authorized for sale, we will have successfully doubled our labeling and packaging capacity to over 1 million Udenica units annually, consistent with the rest of our supply chain. We will be ready to meet the growing demand for Udenica and expect substantial market share increases in 2025 and beyond. Now I'll turn to Lactorsi, approved in nasopharyngeal cancer, and our first commercial immuno-oncology agent. Lactorsi sales grew 54% quarter over quarter as we continue to execute well against our launch plan. Paul Reeder, my chief commercial officer, will provide more detail later on our call, so let me just say that we have tremendous confidence in long-term potential for Lactorsi in the treatment of NVC and as a foundational element of our combination therapy strategies. As our pipeline of innovative immuno-oncology drug candidates, let me share why I'm so excited about the opportunities there. First, our differentiated and diversified portfolio includes promising tumor microenvironment immunotherapy antibody drug candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunological response and improve outcomes for people living with cancer. Second, our targeted development strategy focuses on combinations that have established proof of mechanism, providing a strong line of sight into target tumor types with the most potential for improving efficacy in the areas of unmet need. And thirdly, our drug candidates target large addressable patient populations and attractive market opportunities across several high unmet need tumor types that in turn will drive substantial shareholder value in the upcoming years. As far as near-term catalysts, I will let Dr. Teresa Lavalle and Dr. Raj Dias speak to the detail, but we look forward to reporting on phase one and two clinical trials for CHS114 and CAS-DOHSO, respectively, in the first half of 2025. Lastly, I'd like to reiterate that disciplined financial management remains a high priority at Coherence, and we are now seeing the positive impact from our cost-saving efforts over the last year reflected in our balance sheet, which Brian McMichael, our chief financial officer, will cover later on this call. We are very confident in our ability to create long-term value for our shareholders through both our product portfolio and our competitively positioned pipeline. We are executing well against our strategy and goals for the year and are excited about where our vision can take us moving forward. And with that, I'll turn the call over to Paul.