Seagen Inc.

Good day, everyone, and welcome to the CGN fourth quarter and full year 2022 conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star and then one on your touchtone phones. To withdraw your questions, you may press star and two. Please also note today's event is being recorded. At this time, I'd like to turn the conference call over to Doug Bessay, Vice President, Investor Relations.

Sir, please go ahead. Thank you, Operator, and good afternoon, everyone. I'm pleased to welcome you to CGEM's fourth quarter 2022 Financial Results Conference call. This afternoon, we issued a press release with our results. The press release and supporting slides are available on our website in the Investors section, Events and Presentations page. Speakers for this call will be David Epstein, Chief Executive Officer, Chip Romp, Executive Vice President, Commercial US, Todd Simpson, Chief Financial Officer, and Roger Dancy, President of Research and Development. Following our prepared remarks, we'll open the line for questions. We aim to keep this call to one hour, and ask that you limit yourself to one question to give everyone an opportunity to participate in Q&A during our call today. Today's conference call will include forward-looking statements regarding future or anticipated events and results, including the company's 2023 financial outlook, anticipated products, use costs and expenses, potential clinical and regulatory milestones, including data readouts and regulatory submissions, potential marketing approvals, and commercial performance. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the difficulty in forecasting sales, revenues, costs, and expenses, and the uncertainty associated with the pharmaceutical development and regulatory approval process. More information about the risks and uncertainties faced by CGEN is contained under the caption risk factors, included in the company's quarterly for the quarter ended September 30th, 2022, filed with the Securities and Exchange Commission, and the company's subsequent reports filed with the SEC. Now, I'll turn the call over to David.

Thank you, Doug, and good afternoon, everyone. Today, we reported total 2022 revenue of nearly $2 billion, reflecting 25% growth over 2021. This included record net product sales of $1.7 billion, driven by meaningful uptake across our entire commercial portfolio. Our sales guidance for 23 reflects our optimism and our ability to gain market share in existing indications and grow into newly labeled indications. In a moment, I will take you through the strategy we presented at the JPMorgan Healthcare Conference last month. But first, I'd like to begin by reflecting on an exceptional year for CJIN and noting a few 2022 accomplishments. Beginning with our commercial products, we received regulatory approvals and reimbursement decisions in multiple markets. We now have commercial presence in 17 countries. We deliver robust development progress across our approved brands, including positive results for four pivotal trials that have already resulted in two label expansions and completed enrollment for two potentially registration-enabling studies in our PADSEV and two Kaiser franchises. We advanced a broad, recently prioritized pipeline of differentiated assets, including potentially transformative programs like DV, STNB6A, and STNB7H4V, while at the same time initiating phase one studies for multiple new drug candidates. BGEN also entered into multiple corporate development agreements for new assets that are complementary to our expertise. For example, we secured global rights to an exciting preclinical gamma delta bispecific T-cell engager for EGFR-expressing solid tumors and entered into a collaboration with Sanofi for the development of multiple novel ADCs. Looking ahead, we're focused on three strategic pillars. The first is focused on optimizing the full potential of our commercial portfolio of first or best-in-class products, demonstrated clinical and real-world benefits. Here we are working to enhance our commercial execution and footprint as well. In parallel, we're executing robust clinical development programs, including 10 potentially registrational studies for our approved products in areas of opportunity spanning multiple tumor types. These new labels could unlock meaningful growth across our approved brands and broaden their reach to significantly more patients in need. Eccentris further demonstrated its clinical value in 2022 with important data readouts, a label expansion program, and three sequential quarters of record sales. Eccentris is a U.S. standard of care in frontline Hodgkin lymphoma, has seven U.S. indications following the approval of a pediatric label late last year, and is expected to reach blockbuster status in our territories in 2023. Outside of the U.S. and Canada, our partner, Takeda, continues to deliver Eccentris in international markets, and their product was recently added to the national reimbursement drug list in China. I'll now turn to PADSEV, which we believe has the potential to become our second blockbuster brand. The FDA granted priority review for an application seeking accelerated approval for the combination of PADSEV and Keytruda in first-line metastatic bladder cancer for patients that are cisplatin ineligible with a target action date of April 21st, 2023. Our goal is to advance PADSEV's utility into earlier stages of bladder cancer and our robust clinical development program includes both muscle and non-muscle invasive forms, representing even larger potential patient segments. We continue to evaluate PAD-SEP beyond bladder cancer and expect to report data from the solid tumor study later this year. We're also looking to expand PAD-SEP globally in partnership with Astellas, following its approval in the EU and other countries, including Japan. Moving on to Tokaiza. This brand provides significant benefit for adults with HER2-positive metastatic breast cancer, particularly those with brain metastases. Tukeiza is now approved in 39 countries, and we continue to make progress expanding its use outside of the US with multiple country launches planned in 2023. Last month, Tukeiza received an accelerated approval for patients with previously treated HER2-positive metastatic colorectal cancer, and it was subsequently added to the NCCN guidelines. This is a modest-sized but important population, as these patients typically have poor outcomes following progression on frontline therapy. Our broad development program includes combinations of two Kaiser with ADCs, such as Casila, which is used in second-line plus metastatic breast cancer in a trial called HER2-CLIM-O2. Our partnership with Merck also extends through Kaiser's reach outside of the U.S., Europe, and Canada. TIVDAC is our newest commercial product and continues to receive recognition as an important treatment option for cervical cancer. TIVDAC is now a preferred regimen for second-line or subsequent recurrent or metastatic cervical cancer per the NCCN guidelines. We and our partner, GenMab, are advancing a phase three trial that could support international marketing authorizations, as well as serve as a confirmatory trial in the U.S. with potential top line data expected by year end 2023. Our second strategic pillar is to prioritize the clinical development of assets that we believe will have the most transformative impact on patients and our business. We recently initiated a portfolio prioritization discipline to critically assess data, chance of success, unmet medical needs, and potential patient opportunity. Based upon this analysis, we have prioritized the most promising assets and programs, optimizing the risk-benefit-reward balance across our entire portfolio. Examples of programs that will receive priority resourcing are DV, B6A, and B7H4. These are ADCs with large potential indications and global or near-full global rights and economics that float decision that could help transform our company. Importantly, we remain focused on the combination of adult ADCs and anti-PD1s, given the growing body of data demonstrating the clinical synergy through immunogenic cell death. As such, we have nine trials underway exploring this combination. Our third strategic pillar is to advance innovative next-generation ADC technologies to empower our pipeline for years to come. Several products utilizing our technology are now approved with many other pipeline assets in development. We believe the ADC market will in time be measured in the tens of billions of dollars. In parallel, our teams are working on multiple waves of new ADC technologies that we believe will come to fruition at varying time points. For example, We're developing ADCs employing novel orostatin and chemtothecin technologies, as well as ADCs that incorporate new cytotoxic and immunostimulatory payloads. Further out, we expect ADCs to utilize novel drug conjugate technologies that employ other diverse mechanisms of action. We continue to invest in cutting edge technology to retain our leadership position and expand the number of approved ADCs in order to reach still more patients. We remain selective and opportunistic. in supplementing our pipeline with complementary external assets that could also have exciting potential. With that, I'll turn the call over to Chip, who will provide an update on our commercial performance. Then Todd will discuss our financial results and 2023 guidance. After that, Roger will detail our clinical development activities and pipeline. Take it away, Chip.