Coherus Oncology, Inc.

Hello, everyone, and welcome to the Coherence fourth quarter year ending 2024 financial results 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 participate, you will need to press star 11 on your telephone. You will then hear a message advising your hand is raised. To withdraw your question, simply press star 11 again. please re-advise that today's conference is being recorded. Now it's my pleasure to turn the call over to the Head of Investor Relations, Jody Sievers. Please proceed.

Thank you, Carmen. Good afternoon, and welcome to Coherence Biosciences' fourth quarter and full year 2024 earnings conference call. Joining me today to discuss our results are Denny Lamphere, Chief Executive Officer of Coherence, Brian McMichael, Chief Financial Officer, Paul Reeder, Chief Commercial Officer, Dr. Rosh Dyess, Chief Medical Officer, Dr. Theresa LaValley, Chief Development Officer, and Samir Gorogalkar, Senior Vice President of Immuno-Oncology Marketing. Before we get started, I would 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. projections about future revenues, headcount reductions, statements about our ability to satisfy the closing conditions of the Udenica divestiture, statements about the use of proceeds from the Udenica divestiture, and our projected future cash and cash runway, and statements about future clinical development progress. 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 about achieving the closing of the Udenica divestiture that are discussed in our press release that we issued today, as well as the documents that we filed 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. All December 31, 2024 financial amounts discussed today have not been audited and are subject to change upon completion of Coherence's audited financial statements for the year ended December 31, 2024 that will be included in Coherence's Form 10-K, which is expected to be filed with the SEC in the coming days. And now, I'll turn the call over to Denny.

Thank you, Jodi, and thank you all for joining us today. My cohort here is Q4 and full-year 2024 earnings call. Today, I'll provide you with a view of the progress we've made in 2024 and our key objectives, and I'll describe to you the path that lies ahead as we focus on maximizing revenues and electricity, expanding its syndications, and advancing our proprietary pipeline combination with Lactorsi. On our previous calls, I outlined our four-part strategy to position coherence for future success in innovative oncology. This included, first, to drive top-line revenues, second, control the expense line, thirdly, to advance the innovative pipeline, and lastly, to address the debt overhang on our balance sheet. I'm happy to report that over 2024, we have been successful across all these objectives in support of our overarching strategy. Particularly given last year's strong execution, we are now well positioned in 2025 to complete our strategic transition to a fully integrated commercial stage innovative oncology company. We have addressed our balance sheet debt issue and we'll put about $250 million in cash on the balance sheet at transaction close to continue our development efforts through key data milestone readouts in 2025 and 2026. The most significant change for the company is the divestiture of the Udenica franchise, and I'm happy to report that we have made substantial progress, positioning us to complete this transaction in late Q1, early Q2. Security Exchange Commission review, Hart-Scott-Rodino review, and CFIUS review have all been completed or otherwise approved. The shareholder vote and the special meeting are tomorrow. We are confident that the divestiture will be approved and believe that such approval will constitute both an endorsement of our overarching strategy as well as an appreciation for the strong execution that got us here. However, it must be said on a more macro level that we are certainly not satisfied with our current stock price. Post-transaction, with the debt overhang behind us, a strong balance sheet, and potentially exciting data in front of us. We will focus on enhancing investors' appreciation and understanding of Coeris' value proposition. This will be a key focus of management in 2025 and 2026. Now back to the divestiture. Apart from the shareholder vote, the primary remaining closing condition at this point is the FDA authorization to sell final package product from our additional contract manufacturing organization, responsible for our labeling and packaging operations. We've made the required submission and believe it fully conforms with FDA expectations, as well as the FDA's communicated guidance to us. This final step in our strategic transformation follows a series of achievements over the past two years. In January 2021, we initiated a deliberate four-year strategic transformation process with the in-licensing of Toro Palmet, our differentiated PD-1 inhibitor from June Sheet Biosciences. To be a major commercial player in innovative oncology, we believe it is a strategic necessity to have an approved proprietary PD-1 to anchor in innovative oncology pipelines. Lactorsi is our key foundational asset and will be used in combination with both our own pipeline candidates as well as our partners, driving development synergies as well as sales synergies from proprietary combinations. Lactorsi was launched in Q1 last year and is now standard of care in all lines of nasopharyngeal cancer. In September 2023, we acquired a promising pipeline of oncology candidates through the acquisition of Service Oncology for a net $40 million, inclusive of global rights to a first-in-class anti-IL-27 agent, Castozokita, as well as a highly selective cytolytic CCR8 antibody, CHS114. While these assets were underappreciated at the time, the strong inherent biology and early clinical data convinced us that these are differentiated and potentially game-changing, ideally suited for development in combination with lactorsy. That data is rolling out in front of us now, particularly in liver cancer with Casdozo, and gives us confidence that we were right. and that future data readouts will further validate the clinical utility of these assets. Having thus secured our innovative oncology future with a promising pipeline, last year in 2024, we divested our Ophthalmology and Humira Biosimilar franchises for about $240 million in total consideration and transferred financial obligations. Over this past year, assuming the Eugenica transaction closes and things happen as planned, We will have divested at least $800 million in assets or commitments, paying off $480 million in debt, all with an average capitalization around $175 million. Going forward, we're left in good position with $250 million on the down sheet, a differentiated PD-1 enjoying growing sales in a market where it's standard of care, indication expanding pivotal trials underway for our PD-1 funded by others, and a strong pipeline addressing a $15 billion potential sales opportunity in combination with Lectorzy. And with that, let me now turn it over to my team for more color and details in each of their areas. First, on the commercial side, you'll hear from Paul Reeder, our Chief Commercial Officer, whose team has done an excellent job with Udenica navigating the supply interruption and the subsequent reentry into the market. Paul's team delivered some strong Udenica numbers for us in Q4, all things considered against obvious headwinds. You will also hear today from Samir Gorogalkar, who joined us in Q4 as the new Lactorsi brand lead. Samir is tightly focused on maximizing the potential for the Lactorsi label, NCCN guidelines, as well as customer and patient segmentation, which he will discuss with you. Samir will continue to provide his insights on Lactorsi performance on these calls going forward. After commercial, Dr. Teresa Lavalle will discuss our overarching development strategy, and Dr. Ash Dias, our Chief Medical Officer, will cover our clinical trials and provide additional color on the evolving ASDOSO CHS114 data sets. Lastly, before we conclude our prepared remarks and go to the question and answer session, Chief Financial Officer Brian McMichael will review the Q4 and 2024 annual numbers and deltas for you as well as provide some color on matters going forward. Without the transaction closed, we will not be guiding on 2025 expenses at this point. But of course, we'll do so for you on the Q1 call in May. And with that, I'll hand it over to Paul and Samira for the commercial review. Paul?