Seagen Inc.

And welcome to the CJEN fourth quarter and full year 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. To ask a question, you may press star, then one on your telephone keypad. To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Peggy Pinkston, Senior Vice President, Investor Relations. Please go ahead.

Thank you, Operator, and good afternoon, everyone. I'm pleased to welcome you to CGIN's fourth quarter and full year 2021 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 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 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 2022 financial outlook, anticipated product sales, revenues, costs, and expenses, and potential clinical and regulatory milestones, including data readouts, regulatory submissions, and potential marketing and reimbursement 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 quarterly report on Form 10-Q for the quarter ended September 30th, 2021, filed with the Securities and Exchange Commission, 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. Today, we reported $1.4 billion in 2021 net product sales, a 38% increase over 2020, driven by solid growth across our commercial portfolio. Royalty revenues increased to $151 million in 2021, a 19% year-over-year increase, reflecting sales growth by our collaborators. Our total revenue guidance for 2022 is $1.67 to $1.75 billion, excluding TIDDAC. With a strong balance sheet and a cash position of $2.2 billion, we are well positioned to advance our pipeline through internal and external investments. Todd will walk us through our 2022 financial guidance. But first, I'd like to begin by reflecting on another exceptional year for CGEM. We achieved important milestones in 2021 and continued to expand our global infrastructure and portfolio. I'll begin with our commercial products. At Cetrus is a US standard of care in frontline Hodgkin lymphoma and peripheral T cell lymphoma and forms the foundation of our core business from a revenue standpoint. Etcetera has received approval in more than 75 countries, and we and our partner, Takeda, continue to provide this important drug to patients in need. Notably, last week, we announced that the Phase 3 Echelon 1 clinical trial demonstrated a statistically significant improvement in overall survival in advanced Hodgkin lymphoma patients treated with Etcetera plus chemotherapy in the frontline setting. Over 30 years ago, ABVD was established as standard of care for treating Hodgkin's disease, and almost 15 years ago, data regarding intensified VACOP was initially released. We are thrilled that ETCETRIS plus ABVD has now improved overall survival, and we believe these groundbreaking data further demonstrate ETCETRIS' clinical value and importance in this disease. PADSEV is a first-in-class ADC which has become a standard of care in the U.S. for previously treated metastatic urothelial cancer. PADSEV has been broadly adopted by U.S. oncologists to treat more than 6,500 patients to date. Last year, PADSEV received regular U.S. approval and was also granted a cisplatin-ineligible second-line indication. Together with our partner, Astellas, in 2021, we secured approvals in Canada, Switzerland, Israel, and Japan. We are progressing regulatory submissions across Asia Pacific and the Americas. PATSEP received a positive CHMP opinion in December 2021. Recently, the European Commission decision-making process was paused for additional CHMP questions related to severe skin reactions in a French compassionate access program. This side effect is described in the USPI and, since launch, has been well managed by U.S. prescribing physicians. We believe that the risk-benefit profile of PADSEP remains unchanged. we are committed to working with European authorities to get this important drug approved for urophilial cancer patients. Beyond these global regulatory activities, we are advancing a robust clinical development program with PADSEV as monotherapy and in combination with Keytruda in earlier lines of therapy. We completed enrollments of EV103 cohort K and expect data in the second half of this year which could potentially support accelerated approval in the U.S. in 2023 for first-line metastatic neurothelial cancer. We are also exploring earlier stages of bladder cancer, which represent larger market opportunities. In muscle-invasive bladder cancer, we will report neoadjuvant monotherapy data at ASCO GU later this month, and we are now enrolling patients in a trial for non-muscle-invasive bladder cancer. Finally, we are conducting a basket trial evaluating PADSEP and other NECTIN-4-expressing solid tumors. Tucaisa is a best-in-class HER2 tyrosine kinase inhibitor with broad potential in HER2 cancers. Overall survival data and inclusion in key treatment guidelines reflects its clinical value in second- and later-line HER2-positive breast cancer patients with and without brain metastasis. UKISA is approved in 36 countries, and we have commercially launched in the U.S., Germany, France, Switzerland, and Austria. We are working to secure reimbursements and are planning launches in additional European countries over the course of 2022. We recently announced the appointment of Lee Heeson as Executive Vice President, Commercial International. We look forward to Lee's contributions towards our continued ex-U.S. expansion. Our strategic partnership with Merck extends to Kaiser's reach outside of the US, Europe, and Canada. To Kaiser's broad clinical development program includes HER2-positive breast cancer, colorectal cancer, gastric cancer, and other HER2-amplified or mutant tumors. Notably, we expect data from the phase two Mountaineer trial in the second half of this year, which could potentially support accelerated FDA approval in colorectal cancer in 2023. CGEN's fourth approved product is TIVDAC, which we launched in collaboration with GenMAP. TIVDAC, which is a tissue factor targeted ADC, was approved for recurrent or metastatic cervical cancer patients with disease progression on or after chemotherapy. It represents an important new drug in a disease that is characterized by low objective response rates and poor outcomes. TIVDAC's clinical development program is designed to support global regulatory applications and maximize its future potential in cervical cancer and other solid tumors. As we look to expand TIVDAC in cervical cancer, we recently presented promising combination data in earlier lines of treatment, which could lead to use in much larger patient populations. In 2021, we also drove key advancements across our deep and diverse pipeline. For example, we in-licensed the late-stage novel ADC, Decidimab-vidotin, which utilizes a high-affinity HER2 antibody with enhanced internalization compared to Trastuzumab. DV received conditional approval in China for third-line gastric cancer and recently in second and later lines of metastatic urothelial cancer. Our clinical development program prioritizes model therapy and combination approaches in breast, bladder, gastric, and other cancers. DV utilizes our vedotin-based ADC technology, and leveraging our expertise, we are working to maximize its development, potential value, and global reach. Turning to our earlier stage work, we recently initiated two trials for two novel ADCs. SGN PDL1V and SGN B7H4V. And we have also submitted an IND which just cleared for SGN ALPV. We are developing new ADC technologies in order to widen the therapeutic window of this exciting class of drug with a focus on improving tolerability. In addition, we have four programs that use our proprietary sugar engineered antibody technology. Overall, we are advancing more than 17 programs across our pipeline and approved products in a range of solid tumors and hematologic malignancies. Next, I want to provide a brief update on the Daichi Sankyo litigation. Recently, the arbitration hearing record was reopened by the arbitrator to consider additional evidence. As a result, the decision may occur after the first quarter of 2022 as previously anticipated. Our 2021 achievements have helped to bolster our resilient core business and the solid foundation we continue to build upon. We expect to achieve many milestones in 2022, including important clinical data readouts, global regulatory and commercial progress, and advances across our pipeline. which will help drive future growth. As we look to deliver continued innovation and develop transformative therapies, we remain focused on three key areas. First, we are working to maximize the potential of our approved portfolio through exceptional commercial execution, clinical development, and strategic partnerships. We've expanded our commercial portfolio from one to four products in under two years, and have treated over 110,000 patients to date. Robust clinical development programs will generate the potential for future label expansions and opportunities. Second, we are advancing our deep and diverse pipeline of assets as we look to bring drugs five, six, and seven to market in the coming years. We believe our ADC leadership and R&D expertise in empowered antibodies provides us with a competitive advantage when it comes to expanding and progressing our pipeline. Finally, we are well positioned for continued innovation and growth, having built and optimized our infrastructure and capabilities. Our expanding geographic footprint and over 50 strategic partnerships maximize our ability to reach patients across the globe. Our strong corporate development team and significant financial strength allows us to execute upon deals that will further accelerate our trajectory. Next, I'll turn the call over to Chip, who will provide an update on our commercial performance. Then, Tata will discuss our – after that, Roger will detail our clinical development activities and pipeline.