Seagen Inc.

Welcome to CJEN first quarter 2021 financial results conference call. All participants will be in 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. Please note, this event is being recorded. I would now like to turn the conference over to Peggy Pinkston, Senior Vice President of Investor Relations. Please go ahead.

Thank you, Operator, and good afternoon, everyone. I'd like to welcome all of you to CJIN's first quarter 2021 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 investor section events and presentations page. Speakers on today's call will be Clay Segal, President and Chief Executive Officer, Chip Romp, Executive Vice President, Commercial U.S., Todd Simpson, Chief Financial Officer, and Roger Danzy, Chief Medical Officer. Following our prepared remarks, we'll open the line for questions. We aim to keep this call to one hour and to 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 2021 financial outlook, anticipated product sales, revenues, costs and expenses, and potential clinical and regulatory milestones, including data readouts, regulatory submissions and approvals. 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, and expenses, impacts related to the COVID-19 pandemic, and the uncertainty associated with the pharmaceutical development and regulatory approval process. More information about the risks and uncertainties faced by CJEN is contained under the caption risk factors, including the company's annual report on Form 10-K for the year end filed with the Securities and Exchange Commission and the company's subsequent reports filed with the SEC. And with that, I'll turn the call over to Clay.

Thank you, Peg, and good afternoon, everyone. Following a transformational 2020, we continue to make substantial progress in the evolution and global expansion of our business. We remain focused on investments to maximize the opportunity and value of our assets, fueling our ability to advance cancer care worldwide. We look forward to sharing key business, regulatory, and development progress on the call today. We reported record net product sales in the first quarter, representing 3% sequential quarterly growth and 52% growth over the first quarter of 2020. These results reflect rapid adoption of both Padset and 2Kaiza on top of strong sales of Etcetera's. Our financial strength is driven by product sales, as well as royalties and multiple strategic collaborations. We ended the quarter with $2.5 billion in cash and investments, which positions us to expand our programs, advance our research and development, and invest in our business. As we look ahead, we're focused on three strategic priorities to drive continued innovation and growth. Focusing on these key pillars will ensure our organization is aligned and empowered to deliver substantial benefit to shareholders, our employees, oncology health cancer patients. Our first strategic priority is to maximize the global potential of our three approved medicines through robust clinical development programs and exceptional commercial execution. I'll begin with Etcetera, a remarkable product that is the foundation of care in multiple CD30-expressing lymphomas. With six indications in the U.S., Etcetera serves as the basis of our core business. Etcetera is commercially available in 76 countries. Importantly, our partner Takeda continues to pursue additional approval for frontline Hodgkin lymphoma and peripheral T-cell lymphoma in its territories. We are committed to maximizing ETCETRUS' patient reach and are advancing a clinical development program in Hodgkin lymphoma and multiple other malignancies. Our global success with ETCETRUS is enabling us to continue investing in our pipeline in newer medications. Our next key product is PADSAT, a first-in-class ADC that has quickly become standard of care in previously treated metastatic neurofilial cancer. Locally advanced and metastatic urothelial cancer is an aggressive disease with poor survival, high associated healthcare costs, and limited treatment options. PatServe is the first drug to improve survival after patients have received a platinum chemotherapy and a checkpoint inhibitor. Since the beginning of 2021, we've made substantial progress with health authorities toward expanding the U.S. label and securing global approvals across America. Roger will share details about these activities during his remarks. We're also advancing two trials designed to redefine frontline treatment for metastatic neurofilial cancer patients globally with a focus on the combination of PADSEP and Keytruda. And we continue to make significant headway in exploring earlier stages of bladder cancers. In collaboration with Astellas and Merck, PAD-7 is being tested in two randomized Phase III trials in muscle-invasive bladder cancer patients, and we intend to initiate an exploratory study of PAD-7 in non-muscle-invasive bladder cancer. Our third key product is to customize a best-in-class HER2 tyrosine kinase inhibitor for HER2-positive metastatic breast cancer patients with and without brain metastasis. Tucaisa is now approved in 36 countries. In February, the European Commission approved Tucaisa in the EU, granted its marketing authorization in Great Britain. This is a significant milestone for patients in Europe who will, for the first time, have an approved medicine that has demonstrated a survival benefit for HER2-positive metastatic breast cancer after disease progression following two anti-HER2 treatment regimens. In anticipation of these approvals, over the past year, we've established affiliates in key European countries and built teams with deep industry experience. We recently launched Tecaisa in Germany, France, and Austria. We're pleased by the early uptake, physician feedback, and that Tecaisa has already been included in some key treatment guidelines given the strength of clinical evidence. Through our expanded European footprint, we are poised to execute upon another upcoming CHISA launches and collaborate with individual countries to maximize its ability, availability, and patient access. We are conducting a broad clinical development program design, including trials evaluating it in HER2-positive breast, colorectal, and gastric cancers, and in HER2 mutant tumors. Our second strategic priority is to advance our late-stage programs towards securing approvals for new products. One such asset is Tisodum abdodum, or TB. Earlier this month, FDA accepted for prior review our BLA seeking accelerated approval for TB with an action date of October 10th. The submission comprised data from the innovative 204 pivotal phase 2 trial, which was published in The Lancet Oncology. This is an important development in the treatment of cervical cancer, which remains one of the leading causes of cancer death in women globally. TB is positioned to be our fourth commercial product as we look to expand our portfolio further, and together with our partner, GenMab, we are preparing for its launch. Our third strategic priority is to advance our innovative early stage pipeline through continued leadership and innovation in antibody drug conjugates, internal R&D investments, and corporate development opportunities. Our earlier stage pipeline includes seven programs in clinical trials and multiple preclinical assets advancing toward INDs. I'm proud of the remarkable progress we've made in growing and evolving our business and assets to better meet the needs of cancer patients. Next, I'll turn the call over to Chip, who will discuss our commercial business. Then, Todd will provide an overview of our quarterly financial results. After that, Roger will detail our clinical development and pipeline progress.