Seagen Inc.

Good day and welcome to the CGEN fourth quarter and full year 2020 financial results 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 the star then one on your telephone keypad. To withdraw your question, please press star then two. Please note that this event is being recorded. I would now like to turn the conference over to Ms. Peggy Pinkston, 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 fourth quarter and full year 2020 financial results conference call. This afternoon, we issued a press release with our results, and that press release and supporting slides are available on our website in the investor section events and presentations page. Speakers on our call today will be Clay Segal, President and Chief Executive Officer, Chip Bromp, 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 so 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 commissions, 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 CGEN is contained under the caption risk factors included in the company's current report on Form 8-K, filed with the Securities and Exchange Commission on December 29th, 2020, and the company's subsequent reports filed with the SEC. And now I'll turn the call over to Clay.

Thank you, Peg, and good afternoon, everyone. The past year was pivotal in the evolution of our business. We expanded our geographic footprint and operations beyond the United States and Canada, with presence across greater Europe as we prepare for additional launches of TKISA. We are now a multi-product global oncology company with substantial financial strength to fuel ongoing company investments. We have laid a strong foundation for continued growth and the ability to bring important medicines to cancer patients in need. I'll start with a summary of our recent financial performance. We reported record 2020 product sales in our territories of just over $1 billion, reflecting a 59% annual increase. These results were driven by successful PADSEV and JICAISA launches, as well as continued strong et cetera sales. Total revenues were $2.2 billion in 2020, which included royalties and collaborations, notably our new strategic partnership with Merck. We ended 2020 with $2.7 billion in cash and investments, which strongly positions us to continue advancing our programs. In 2021, we expect to see continued growth of PADSEP and ChuKaiza and maintain market share for Etcetera, with anticipated product sales in our territories of approximately $1.3 billion. Todd will walk us through our 2021 guidance, and Chip will discuss the commercial dynamics. But first, I'd like to reflect upon the past year. During 2020, we delivered multiple important business, regulatory, and development milestones. I'd like to provide you with a few highlights, beginning with Etcetera's. Our partner Takeda gained more ex-US approvals, including in China. Additionally, in December, we presented data from the Echelon 1 and Echelon 2 Phase 3 trials at ASH, demonstrating robust and durable remissions at five years. This is a clinically meaningful and important milestone in a cancer patient's journey. We are committed to maximizing et cetera's patient reach through our clinical development program in Hodgkin lymphoma and other CD30-expressing malignancies. Next, I'll turn to PADSEV, a first-in-class ADC that we're developing and commercializing in collaboration with Astellas. PADSEV has shown rapid adoption since its FDA accelerated approval for metastatic urothelial cancer just over a year ago. In 2020, we announced positive top-line results from two PADSEV studies. This included strong data from our single-arm Phase II trial in cis-ineligible metastatic urothelial cancer patients previously treated with an immune checkpoint inhibitor. We expect to submit these data to FDA in a supplemental BLA within the next few weeks. Last year, we also reported top-line results from a randomized Phase III trial in patients with previously treated metastatic urothelial cancer. Results demonstrated that PADSEV significantly improved overall survival and progression-free survival versus standard-of-care chemotherapy. These data will also be submitted to FDA, resulting in two concurrent supplemental BLAs in the next few weeks. In addition, global submissions for these trials are planned to support marketing applications in the EU and Japan later this quarter. Also last year, we received breakthrough therapy designation for PADSET in combination with Keytruda in first-line metastatic urothelial cancer. We are currently enrolling two trials designed to support approval in first-line metastatic patients, one to support accelerated approval in cis-ineligible patients, and the other to support global approvals in patients regardless of platinum eligibility. Our goal is to redefine first-line treatment for metastatic urothelial cancer patients around the globe. Finally, in 2020, we made significant headway in exploring earlier stages of bladder cancer. In collaboration with Astellas and Merck, PAD-7 is being tested in two randomized Phase III trials in cis-ineligible and cis-eligible muscle-invasive bladder cancer patients. Now, on to TKAISA, a best-in-class HER2 TKI for HER2-positive metastatic breast cancer patients with and without brain metastasis. In 2020, TKAISA was also approved in the United States, as well as Australia, Canada, Singapore, and Switzerland under the FDA's Project Orbis. In December, we received a positive CHMP opinion recommending the European Commission approval of Tukaiza in the EU, and we are preparing for its potential launch further extending Tukaiza's reach. Lastly, in order to accelerate the commercialization of Tukaiza in regions beyond the US, Canada, and Europe, we entered into a strategic collaboration with Merck in 2020. Our three currently approved products are important first-in-class or best-in-class medicines that have been embraced by oncologists. We are making substantial investments in their continued development, which will provide growth catalysts in future years. We believe that each of the brands have blockbuster potential. Etcetera is a mainstay in the treatment of CD30 lymphomas and has achieved strong market penetration in its six indications. Global sales of etc. in 2020 were approximately $1.2 billion, and nearly 83,000 patients around the world have received etc. therapy. We expect that the impact of COVID-19, which is leading to fewer frontline Hodgkin lymphoma diagnoses, will resolve in time, but this is hard to predict. We believe that future growth of etc. will be primarily based on label expansion supported by our multiple ongoing trials that we expect to read out in the next few years. PADSAT has become the standard of care in its current labeled indication. We expect that both supplemental BLA submissions, if approved, will further strengthen PADSAT's role in the treatment of patients with advanced metastatic urothelial cancer. Looking toward first-line metastatic bladder cancer, we expect to complete enrollment in the cohort K accelerated approval trial by the end of this year. Factoring in a follow-up period to observe duration of response, data from this cohort could support a supplemental BLA in 2022. In addition, three large Phase III trials are currently enrolling in first-line metastatic urophelial cancer and muscle-invasive bladder cancer. These trials are intended to serve as the basis for multiple global submissions in the future. Tucaiza is an important medicine that has been rapidly adopted by oncologists. We're planning launches in Europe during 2021, as well as seeking reimbursement approvals on a country-by-country basis. Additionally, we're conducting several large, potentially pivotal trials in breast, gastric, and colorectal cancers. We expect to complete enrollment in the Mountaineer trial in colorectal cancer patients by the end of 2021, while our other studies will continue to enroll. Building on the success of ETCETRIS with our six labeled indications, we expect ADCEP and CHISA to reach even more patients in the future. This is based on our ongoing extensive clinical development programs that Roger will describe in detail. I'll now turn to our late-stage clinical development programs, tesodimabvidodine, also known as TB, and lidirutuzumabvidodine, known as LD. Yesterday, we and GenMed announced the submission of a BLA for TV in patients with recurrent or metastatic cervical cancer, positioning it to be our fourth commercial product. This is a significant milestone for CGEN and would further expand our commercial portfolio. We also recently initiated the innovative 301 Phase III study in metastatic cervical cancer, which is intended to support global regulatory applications and serve as the confirmatory trial. Aligned with our goal of addressing the high unmet need for patients with hormone receptor positive and triple negative breast cancer, last year we announced a global collaboration with Merck to co-develop and co-commercialize LBs, The collaboration is intended to accelerate the development of LB and focuses on evaluating this highly active ADC as monotherapy and in combination with Keytruda in Live1 expressing solid tumors. As we look ahead to 2021 and beyond, we are focused on three strategic priorities to drive continued innovation and growth. The first is to maximize the global potential of our three approved medicines through robust clinical development programs and exceptional commercial execution. The second priority is to advance late-stage programs towards securing approvals for new products, including TV and LV. And the third is to expand our already strong and innovative early-stage pipeline through continued leadership and innovation in the ADC space, internal R&D investments, and corporate development opportunities. Focusing on these strategic pillars will ensure our organization is aligned to deliver substantial value to our key stakeholders, notably stockholders, our employees, and especially cancer patients. Next, I'll turn the call over to Chip to discuss our commercial activities. Then Todd will comment on our financial results and 2021 guidance. After that, Roger will discuss our clinical development activities and key milestones for the year ahead. Chip. Thank you, Clay. The commercial team closed out a very successful year with a solid fourth quarter. Launching two drugs in these unprecedented times was a difficult task. Through strong digital marketing strategies, creativity, and outstanding customer relationships, our team delivered. Successful launches of Pad 7 to Kaisa drove 59% total net product sales growth in 2020 over 2019. I would like to thank all my commercial colleagues for their dedication and efforts in 2020 to ensure appropriate patients received our products. Starting with Etcetera's, we reported fourth quarter sales of $164 million. and $659 million for the year, a 5% increase over the full year in 2019. We continue to see an impact on et cetera sales due to the pandemic. Based on claims and electronic medical records data, new Hodgkin lymphoma diagnosis trends continue to be approximately 15% lower than historic levels. We are now promoting the five-year follow-up data from the Echelon 1 trial in Frontline HL. and early reactions to these important data have been favorable. Five-year outcomes are an established standard, and we expect that the durable advantage of etc. will drive incremental share. Moving on to PATSEV, fourth quarter sales were $69 million, an increase of 11% over the third quarter of 2020. Full-year PATSEV sales were $222 million. We received rapid adoption in our labeled indication, and look forward to promoting upon approval the overall survival data observed in the EV301 trial and the Strong Cohort 2 data in metastatic urothelial cancer. Both indications would meet a significant unmet need for patients who have received a prior PD-1 or PD-L1 inhibitor. Our guidance takes into consideration our high market share in our current labeled indication and evolving market dynamics, such as increasing use of PD-1 or PD-L1 inhibitors in the front line. We are confident that PATSEV is well positioned this year for continued growth. Transitioning to Tecasa, fourth quarter sales were $61 million, a 45% increase over the third quarter. Four-year sales of Tecasa were $120 million. We continue to see adoption of Tecasa across its strong label, and payer coverage continues to be solid. We are pleased with the growth we are seeing in both the community and academic settings. I will now turn the call over to Todd.