Coherus Oncology, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Q2 2022 Coherence Bioscience, Inc. earnings conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star, then the number one on your telephone keypad. To withdraw your question, simply press star 1 again. I would now like to turn the call over to Marek. Please go ahead.

Thank you, Mandeep. Good afternoon, everyone, and thank you for joining us. We issued a press release earlier announcing our financial results for the second quarter of 2022. This release can be found on the Coherence Biosciences website and is also attached to our form 8K. Today's call includes forward-looking statements regarding Coherence's current expectations about future events. These statements include, but are not limited to, our ability to launch multiple new products, our ability to generate sufficient sales to achieve revenue growth and profitability, our SG&A and R&D expense guidance, our projected market share, our 2026 top line projections, our projections about market opportunities, and our ability to advance our product candidates and successfully launch our products according to our projected timeline. All 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 results, performance, or achievements implied by the forward-looking statements. These statements are not guarantees of future performance and are subject to substantial risks and uncertainties that are discussed in our press release that we issued today, as well as the documents that we filed with the SEC, including those in our quarterly report on Form 10Q for the second quarter that we filed today. Overlooking 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. With me on today's call are Denny Lanphier, CEO of Claharis, Paul Reeder, Chief Commercial Officer, Dr. Raj Daya, Chief Medical Officer, and McDavid Silwell, Chief Financial Officer. Our Chief Development Officer, Dr. Teresa Lavella, is traveling on vacation and is unable to join us. I will now turn the call over to Danny.

Thank you, Merak, and good afternoon, everyone. Thank you for joining our conference call to review recent business highlights and financial results for Q2 2022. First, let me make a few remarks about progress on our strategy. I'm pleased to report today continued strong execution to transform Coheris into an innovative immunology company driven by revenues from a diversified portfolio of approved products. We've entered into an exciting 12-month period where we expect to launch multiple products, resulting in growing revenues, which will ultimately lead back to profitability. The Coheris team has executed particularly well with respect to Simerly, which is now our third approved product. As you know, earlier this week, The FDA approved our Lucentis biosimilar with the interchangeability designation and interchangeability exclusivity for 12 months. The approval also included both Lucentis dosage strengths and the full Lucentis label. This is important because it means that when we launch later this year, we will do so at the formation of Lucentis biosimilar market with a significantly differentiated biosimilar label relative to other competitors. The one other approved biosimilar has only one approved dosage strength, an incomplete and limited label, and does not have interchangeability designation. Furthermore, two of the potential competitors recently announced regulatory delays and are not expected to launch for a year or more. As Paul Reeder, our Chief Commercial Officer, will elaborate for you in just a moment, the similarly commercial opportunity will leverage our demonstrated strength as seen with Eugenica in buy-and-build markets. For all these reasons, we believe we will do very well with Summerlee, and that our confidence is justified. Our fourth product candidate for our CalMEM, our P1 inhibitor, is back on track due to stellar execution by our regulatory affairs, quality, and manufacturing teams, working alongside our partner, Junshi Bioscience. Together, we rapidly responded to the issues identified in the FDA's April 29th complete response letter, which we characterized at the time as straightforward and readily addressable. Having resubmitted the BLA in less than two months' time indicates both that this was a fair characterization and that our team is highly focused on strong execution across the board. The FDA has assigned a new PDUFA date of December 23, 2022. and we expect to launch Toropalimab very early in 2023 into nasal pharyngeal carcinoma if approved. Our immuno-oncology strategy in the U.S. includes evaluating Toropalimab's ability to deliver substantial clinical benefits and significant indications in combination with other cancer drugs and immunotherapy through co-development agreements or other arrangements designed to drive utilization. Our objective is to establish coherence as a partner of choice for companies seeking PD-1 combinations for their immuno-oncology programs. In a moment, Dr. Raj Dias, our Chief Medical Officer, will detail multiple internal toropalimab combination programs we're advancing in clinical and preclinical development. While we have entered a period of product portfolio growth and top-line revenue inflection, we remain tightly focused on our expense structure and are reducing costs whenever possible. Our Chief Financial Officer, Mr. McDavid-Stilwell, will provide you some additional color in our financial results in just a moment. With an efficient operational structure in place, $275 million in cash at quarter end, and access to an additional $100 million in non-dilutive capital post-approval similarly into our PALMAP, the company is in a strong financial position going forward into the launches. Those launches and continued strong execution across the company support our 2026 top line projections of $1.2 billion to $2.2 billion provided at our Analyst Day event earlier this year. We reiterate this guidance now. We are well on our way to the product portfolio and revenue diversification past Udenica as we have long planned. well-capitalized and was certainly in our direction, we are confident that the multiple anticipated new product launches over the next 12 months will deliver growth consistent with our plans and, as I mentioned earlier, ultimately drive us back to profitability. I'll now turn the call over to Dr. Diaz who will provide you an update on the Toro Palamab BLA review and our other development programs. Rush?