Good day everyone, welcome to the Seagen 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 touch-tone 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 Maffei, Vice President, Investor Relations. Sir, please go ahead. Thank you, operator. Good afternoon, everyone. I'm pleased to welcome you to Seagen'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 on the call will be David Epstein, Chief Executive Officer, Chip Romp, Executive Vice President, Commercial U.S., Todd Simpson, Chief Financial Officer, and Roger Dansey, 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 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 Seagen is contained under the caption Risk Factors included in the company's for the quarter ended September 30, 2022, filed with the Securities and Exchange Commission and the company's subsequent reports filed with the SEC. I'll turn the call over to David. Thank you, Doug, good afternoon, everyone. Today we report a 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 2023 reflects our optimism in 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. First, I'd like to begin by reflecting on an exceptional year for Seagen 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 delivered 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 PADCEV and TUKYSA franchises. We advanced a broad, recently prioritized pipeline of differentiated assets, including potentially transformative programs like DV, SGN-B6A, and SGN-B7H4V, while at the same time initiating phase I studies for multiple new drug candidates. Seagen 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 are 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. ADCETRIS further demonstrated its clinical value in 2022 with important data readouts, a label expansion, and three sequential quarters of record sales. ADCETRIS 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 ADCETRIS in international markets. Their product was recently added to the National Reimbursement Drug List in China. I'll now turn to PADCEV, 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 PADCEV and KEYTRUDA in first-line metastatic bladder cancer for patients that are cisplatin-eligible with a target action date of April 21st, 2023. Our goal is to advance PADCEV's utility into earlier stages of bladder cancer. Our robust clinical development program includes both muscle and non-muscle invasive forms, representing even larger potential patient segments. We continue to evaluate PADCEV beyond bladder cancer and expect to report data from the solid tumor study later this year. We're also looking to expand PADCEV globally in partnership with Astellas following its approval in the EU and other countries, including Japan. Moving on to TUKYSA. This brand provides significant benefit for adults with HER2-positive metastatic breast cancer, particularly those with brain metastases. TUKYSA is now approved in 39 countries, and we continue to make progress expanding its use outside of the U.S. with multiple country launches planned in 2023. Last month, TUKYSA received an accelerated approval for patients with previously treated HER2-positive metastatic colorectal cancer. It was subsequently added to the NCCN guidelines. This is a modest size but important population as these patients typically have poor outcomes following progression on frontline therapy. Our broad development program includes combinations of TUKYSA with ADCs such as Kadcyla, which is used in second-line plus metastatic breast cancer in a trial called HER2CLIMB-02. Our partnership with Merck also extends TUKYSA's reach outside of the U.S., Europe, and Canada. TIVDAK is our newest commercial product and continues to receive recognition as an important treatment option for cervical cancer. TIVDAK 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 III 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 need, 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 B7-H4. These are ADCs with large potential indications and global or near full global rights and economics that flow to Seagen that could help transform our company. Importantly, we remain focused on the combination of vedotin ADCs and anti-PD-1s, 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 vedotin 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 auristatin and camptothecin 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. Todd will discuss our financial results and 2023 guidance. Roger will detail our clinical development activities and pipeline. Take it away, Chip. Thank you, David. The commercial team delivered another strong quarter to close out a very successful year for Seagen. Performance in Q4 underscores strong commercial execution across our portfolio. ADCETRIS fourth quarter sales were a record $238 million, a 35% increase over the fourth quarter of 2021. Year-over-year growth reflects a return to pre-COVID diagnosis rates, favorable gross to nets, and share point gains in frontline Hodgkin lymphoma. ADCETRIS is now a Category 1 preferred agent in the NCCN guidelines, which has resulted in positive changes in treatment pathways and incremental share gains in the frontline setting. We are pleased with the performance of ADCETRIS, and we continue to see opportunities for incremental share gains in frontline HL in 2023. PADCEV fourth quarter sales were $122 million, a 32% increase over the same quarter of last year. These sales included clinical trial supply orders of $6 million for the quarter. PADCEV remains a U.S. standard of care in the second line setting. Underlying growth was primarily driven by patient flow into the second line setting due to continued use of checkpoint inhibitors as frontline maintenance therapy. Meanwhile, our commercial teams are preparing for a potential launch into the frontline metastatic setting in combination with KEYTRUDA in cisplatin-eligible patients. As a reminder, this is a sizable opportunity with approximately 20,000 total addressable patients in the frontline metastatic setting in the U.S.. Around 18,000 of these patients are drug-treated, and approximately 50% are ineligible for cisplatin-based chemotherapy. If approved, the PADCEV combination would represent an additional important new treatment option in the frontline setting. Moving on to TIVDAK, fourth quarter sales were $86 million, down 9% year-over-year. We have established TIVDAK's market position as a valuable treatment option for patients in the second line plus setting, especially for those with active brain metastases. TIVDAK continues to perform well despite ongoing competitive headwinds related to ENHERTU's increased use in the second line plus setting. We expect to see stabilization of patient flow into the third line in the second half of this year. TIVDAK's performance continues to benefit from extended treatment duration of a year or longer in approximately a third of patients, which underscores its efficacy and tolerability. After last month's FDA accelerated approval, our commercial team has now launched TUKYSA in the second line plus setting in patients with HER2-positive metastatic colorectal cancer. This represents the first approved HER2-directed therapy in this setting. Although a modestly sized market of approximately our patients, this population represents a high unmet medical need as existing approved colorectal cancer therapies typically offer limited response rates. In addition, we estimate approximately half of colorectal cancer patients are currently screened for HER2 expression. A focus of our commercial efforts will be on increasing patient screening rates. Looking beyond the U.S., following successful pricing negotiations in the fourth quarter, we launched TIVDAK in Italy and Norway and look forward to expanding access in the coming months. Merck is progressing regulatory submissions and reimbursement activities intended to expand TIVDAK's reach in their territory and has multiple launches planned this year. And finally, TIVDAK sales were $18 million for the fourth quarter, an increase of 7% from the third quarter of 2022. The Seagen and Genmab commercial teams remain focused on ensuring positive treatment experiences and driving further market penetration of this important treatment option. We also look forward to the outcome of the innovaTV 301 global phase III trial later this year, which could result in full FDA approval if it demonstrates an OS benefit and other endpoints, while potentially serving as the basis for global submissions. I'll pass the call over to Todd, who will discuss our financial performance, including our outlook for 2023. Todd? Great. Thanks, Chip, and thanks to everyone for joining us on the call. Our financial results reflect significant progress made across the business in the past year. Today, I'll summarize our 2022 financial performance and then discuss our 2023 guidance. Total revenues were $528 million in the fourth quarter and $1.96 billion for the full-year in 2022, representing year-over-year growth of 23% and 25% respectively. This included record net product sales of $464 million in the fourth quarter and $1.7 billion for the full-year, reflecting year-over-year growth of 26% and 23% respectively. This growth was driven primarily by ADCETRIS and PADCEV, as well as contributions from the launch of TIVDAK. Royalty revenues were $53 million in the fourth quarter and $165 million for the full-year in 2022. Full-year royalty revenues increased 9% over 2021, driven by strong commercial performance by our partners, notably Takeda with its sales of ADCETRIS and Roche with its sales of Polivy. Collaboration revenues were $11 million in the fourth quarter and $91 million for the full-year in 2022. These included royalties on sales of PADCEV by Astellas in its territory, as well as other collaboration revenues, including a new collaboration with Zai Lab in the third quarter. Cost of sales was $108 million in the fourth quarter and $410 million for the full-year in 2022. These include product cost of sales and royalties for each of our four brands, profit share amounts owed to our collaboration partners, Astellas and Genmab, as well as non-cash amortization of acquired technology costs for TUKYSA. R&D expenses were $358 million in the fourth quarter and $1.34 billion for the full-year in 2022. These reflect continued investment to expand the potential of our approved products and to advance our pipeline programs. SG&A expenses were $216 million in the fourth quarter and $821 million for the full-year in 2022. This was driven by ongoing commercialization efforts in the U.S. and Europe, as well as other corporate activities to support our growing business. Next, I will turn to our financial outlook. We expect total revenues in 2023 to be in the range of $2.14 billion-$2.24 billion, representing growth of 9%-14% over 2022. Beginning this year, we are providing product sales guidance at a portfolio level. This reflects the expansion of our commercial portfolio to now four approved products, an increasing number of indications, and expanding geographies. We will continue to report quarterly results at a brand level. With that in mind, looking across the portfolio, we are guiding to product sales of $1.925 billion-$2.0 billion, representing an increase of 13%-17% over 2022. We expect ADCETRIS growth to be driven by continued use across its seven indications, most notably in front-line Hodgkin lymphoma. We expect ADCETRIS to reach blockbuster status in our territories this year for the first time. PADCEV is an important and established brand for the company. Our guidance today does not include contributions from the potential U.S. label expansion for PADCEV, which has a PDUFA action date of April 21st. We expect that ADCETRIS and PADCEV will remain the largest contributors to our sales in 2023. We look at the second half of 2022 as a good indicator of how each of our brands will perform going into 2023. As a reminder, first quarter sales are typically the lowest of the quarters, with growth seen throughout the year. We are excited about the recent label expansion for TUKYSA into metastatic colorectal cancer patients. While the label expansion takes us beyond breast cancer, it represents a relatively modest commercial opportunity. From an overall brand perspective, while we expect contributions from colorectal cancer, we also expect continued headwinds from HER2 and breast cancer in the near term. That will impact overall growth in 2023. Finally, while we continue our efforts to drive TIVDAK growth in its current indication, which has become an important treatment option for women with advanced cervical cancer, we continue to look for future growth opportunities for TIVDAK through our basket trial efforts in other tissue factor expressing solid tumors, and Roger will provide a development update later. We expect royalty revenues to be in the range of $170 million-$185 million, primarily reflecting sales of ADCETRIS by Takeda in its territory, along with contributions from sales of Polivy by Roche. As a reminder, the Takeda royalty rate tiers reset at the beginning of each year. We expect collaboration revenues to be in the range of $45 million-$55 million, which includes PADCEV royalties from Astellas, as well as amounts earned from our other collaboration partners. R&D expenses are expected to be in the range of $1.425 billion-$1.525 billion. This reflects continued investment in clinical trials to further expand our commercial brands, advance our earlier-stage agents, and drive our ADC innovation. SG&A expenses are expected to be in the range of $880 million-$930 million, focused on commercial execution to drive growth of our approved products and to support our overall growth strategy. Cost of sales is expected to be in the range of $420 million-$470 million. Growth over 2022 will be driven by increased product sales and higher profit share payments to our collaborators. Non-cash expenses are expected to be in the range of $330 million-$375 million, the majority of which is stock-based compensation. Taken together, our financial guidance reflects our strategy to support the growth of our current approved brands and fund the development of a growing pipeline. Now, I'll turn the call over to Roger for an overview of our research and development progress. Roger? Thank you, Todd. Good afternoon, everyone. I'm happy to share recent clinical development updates for both our approved medicines and our pipeline. I will begin with ADCETRIS, which is the foundation of care in CD30-expressing lymphomas. Since our last call, we have achieved a number of important milestones. In September, the NCCN guidelines were updated, elevating the ADCETRIS combination to a Category 1 preferred treatment option for adults with previously untreated Stage 3 or 4 Hodgkin lymphoma. Based on the impressive overall survival data from the ECHELON-1 trial. These data are currently under review by FDA for potential inclusion in the label. In November, ADCETRIS was approved by the FDA for pediatric patients two years and older with previously untreated high-risk classical Hodgkin lymphoma in combination with standard chemotherapy based on the Children's Oncology Group study. We continue to evaluate other potential indications for ADCETRIS, including DLBCL and solid tumors, the latter of which we expect to report data in the first half of this year. Moving on to PADCEV. PADCEV has been granted priority review with a PDUFA date of April 21st, 2023 for our supplemental BLA based primarily upon data from Cohort K of the EV-103 trial. As a reminder, this cohort studied the safety and efficacy of PADCEV in combination with KEYTRUDA in front-line cisplatin-ineligible patients with unresectable, locally advanced or metastatic urothelial cancer. At ESMO, we presented data that showed the combination generated an ORR of 64.5%, median cycles of therapy of 11 months, and a median duration of response that had not yet been reached. This week at ASCO GU, analyses evaluating the response of the PADCEV combination across different patient subgroups treated in EV-103 Cohort K will be presented. These data confirm the consistent benefit of PADCEV and KEYTRUDA amongst key patient populations, including those with liver metastases and low levels of PD-L1 expression. Of note, we completed global enrollment of EV-302 in November of 2022 and estimate PFS top-line data to be available by year's end. An extension study in China continues to enroll. This is a global study evaluating PADCEV in combination with KEYTRUDA in both cis-ineligible and cis-eligible patients, which is a broader front-line population than was enrolled in Cohort K. EV-302 is intended to support submissions around the world, including in Europe and Asia, and is the confirmatory trial for a potential U.S. accelerated approval of PADCEV in the EV-103 Cohort K treatment setting. In muscle-invasive bladder cancer, which is a stage earlier than metastatic disease, we continue to advance PADCEV with two ongoing global phase III studies evaluating the combination with KEYTRUDA given perioperatively. In non-muscle invasive bladder cancer, which is the earliest disease stage, we are conducting a phase I study, EV-104, with PADCEV given as intravesical therapy. Initial data may be presented later this year. Beyond urothelial cancer, together with Astellas, we are also considering PADCEV's potential in other Nectin-4 expressing solid tumors, and we'll be sharing initial data in the first half of this year. Continuing with TUKYSA, we recently received accelerated approval in combination with trastuzumab for the treatment of adult patients with previously treated metastatic colorectal cancer. Importantly, NCCN guidelines have been updated to include TUKYSA as a treatment option for patients with HER2 expressing RAS wild-type metastatic colorectal cancer. Clinical situations outlined in the guidelines include a primary treatment option for patients who received adjuvant FOLFOX or CAPOX within the last 12 months, a first-line treatment option for metastatic disease where patients are ineligible for intensive chemotherapy, and second-line and beyond treatment option for patients who progress on any front-line chemotherapy. A phase III trial has been initiated in front-line metastatic colorectal cancer, which is intended to serve as a confirmatory trial in the United States and support global submissions. Moving to breast cancer, HER2CLIMB-02, our phase III study of TUKYSA in combination with Kadcyla in metastatic second-line plus patients, completed enrollment in June of 2022, Top-line data is anticipated in the first half of this year. Kadcyla is an important treatment option for patients with HER2-positive metastatic breast cancer. If the trial is successful, the combination of TUKYSA plus Kadcyla could provide an alternative late-line option, including for patients with brain metastases. Additionally, for TUKYSA, we plan to present data in the first half of this year from our basket trial in combination with trastuzumab in previously treated metastatic solid tumors with HER2 alterations, with a focus on biliary tract cancers. I'll turn now to TIVDAK, which is approved in the United States for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The phase III trial in cervical cancer, innovaTV 301, is close to completing global enrollment, with the potential for top-line data in the second half of this year. This study is intended to serve as a confirmatory trial in the United States and to support global regulatory applications. Beyond cervical cancer, we continue to study the potential for TIVDAK in other malignancies through an ongoing phase II study, innovaTV 207. Initial data with a modified dosing schedule in head and neck cancer is projected to be presented this year. Continuing with disitamab vedotin or DV, this HER2-directed ADC is being evaluated as monotherapy and in combination with KEYTRUDA for the treatment of metastatic urothelial cancer in HER2-expressing tumors. We plan to initiate a phase III trial in frontline metastatic urothelial cancer in combination with KEYTRUDA later this year. Development activities are underway to evaluate DV as a monotherapy and in combination with TUKYSA or KEYTRUDA in HER2-low metastatic breast cancer and HER2-expressing gastric cancer. Moving to our early-stage pipeline, starting with SGN-B6A, a wholly-owned vedotin ADC targeting integrin beta-6. We reported phase I clinical data in November at SITC. In addition to a manageable and tolerable safety profile at the explored dose regimens, the initial antitumor activity observed in heavily pretreated patients with advanced solid tumors appears encouraging and has triggered expansion cohorts in non-small cell lung cancer, head and neck cancer, and esophageal cancer. Focusing on the lung cancer subset, we observed a 33% confirmed objective response rate. Updated clinical data, including initial durability of response, will be reported later this year. Turning now to SGN-B7H4V. This is a novel vedotin ADC targeting the immune checkpoint B7-H4, with potential opportunities in breast, ovarian, and endometrial cancer. We are making progress in the first-in-human trial and anticipate sharing initial clinical data this year. We continue to advance our IND engine with ADCs and other targeted therapies for cancer. In partnership with Sanofi, we are planning a 2023 IND submission for a CEACAM5 targeted ADC with preclinical data supporting the submission to be presented at an upcoming medical meeting. Further, we are planning additional IND submissions with ADCs utilizing novel drug linkers and payloads. SGN-BB228, a costimulatory bispecific, has recently achieved first patient enrolled in a phase I first-in-human trial, initially focused on relapse or refractory metastatic melanoma. SGN-EGFRd2, a preclinical bispecific targeting gamma delta T cells and EGFR-positive tumor cells, is on track for an IND submission in 2023. Over the course of this year, we look forward to achieving multiple important data and regulatory milestones encompassing our approved portfolio and our pipeline assets. Seagen has now emerged as a company with the expertise, capabilities, and passion to discover, develop, manufacture, and commercialize transformative medicine that impact lives. We operate from a position of strength as we work to build Seagen into a leading global oncology company. We will now turn to Q&A. To increase the chances of those participating on today's call have an opportunity to ask questions, we ask that you please limit yourself to one question each. Operator. Ladies and gentlemen, at this time, we'll begin the question and answer session. To ask a question, you may press star and then one on a touch-tone telephone. To withdraw your questions, you may press star and two. If you are using a speakerphone, we do ask that you please pick up the handset prior to pressing the numbers to ensure the best sound quality. Once again, that is star and then one to ask a question. We'll pause momentarily to assemble the roster. Our first question today comes from Salveen Richter from Goldman Sachs. Please go ahead with your question. Good afternoon. Thanks for taking my question. With the non-muscle-invasive bladder cancer data set that's reading out for PADCEV in first half, can you help us, one, understand the mechanistic rationale as we think about the drug working in metastatic bladder and the likelihood of working in this tumor type? Then two, what the bar would be for this to be positive? Then just remind us when the muscle-invasive bladder cancer data will be presented. Sure. Hey, Salveen, it's David. Thanks for the great question. As you know, we're pretty excited about the franchise we're building in bladder cancer and the strategy with PADCEV is to move increasingly to earlier lines of therapy. We're gonna further build upon that bladder cancer presence by eventually introducing DV also into bladder cancer, but directed towards HER2-positive patients. I think you're right to focus on both the muscle and non-muscle-invasive bladder cancer because those markets are so much bigger than where our current approval is. Hey, Roger, I think it'd be best if you could share some insights on that program. Sure, David. No, no problem. Thank you. Salveen, it's a great question. Frankly speaking, the profile, the potential profile of PADCEV given into the bladder, you know, could be an excellent one for the following reasons. Firstly, Nectin-4 is expressed stably across all of the disease states. We have as much Nectin-4 expression in this very early superficial bladder cancer patient population as we would have in metastatic disease. Secondly, when we instill PADCEV in its current formulation into the bladder. We saw this both preclinically and of course we'll share some data clinically when we are able. We had no preclinical systemic exposure. The profile, the tolerability and safety profile of PADCEV may look a little bit more favorable potentially than with systemic administration. We showed in an orthotopic bladder cancer model that we could in fact by giving PADCEV into the bladder, sort of in direct contact with the tumor, impact and have an antitumor effect. I think we're optimistic. We're excited actually about the opportunity and obviously we'll be sharing, you know, that information such as we have later in the year. We are starting in the place where almost everyone does begin, which is with a BCG unresponsive population. These are folks who failed standard therapy. In terms of what could a registration path look like, what could the hurdle look like? I think that has already been defined for that population. There is some FDA guidance with regard to what type of endpoints, things like complete, you know, complete response rates with CIS type disease. We're still, you know, we're still in the exploratory phase. We do see, we can see a path forward for the BCG unresponsive and frankly for a broader population as well, as there are other drugs that are being developed in this space. Great. Thank you. Next question. Our next question comes from Matthew Harrison from Morgan Stanley. Please go ahead with your question. Great. Good afternoon. Thanks for taking the question. I was just wondering, I know obviously guidance doesn't include the potential impact from Cohort K. I was wondering if you could just provide maybe some broader commentary on how you think about the ramp if you are to receive accelerated approval in that setting, and any factors that you think could influence the trajectory in the second half of this year. Thanks. Hey, Matthew, you know, thanks for mentioning that our guidance does not include Cohort K for 2023. I just wanna say the review is going well, and I think, you know, once we have the guidance and we see the label, we will be able to update people. It's likely to be pretty meaningful in terms of incremental sales during the course of the year. I think I'm gonna turn it over to Chip now, if you can give any color on uptake, without going into too much specifics, 'cause I think we're gonna hold a lot of that till we see the final label. Yeah, sure. Thanks, David. I would add just a couple comments. We have an established presence in this marketplace, in the second line setting, PADCEV is now the standard of care, we have good insight into this space, and have the capability of continuing to, you know, grow the brand into the frontline setting. The market itself is substantially larger than the current label that we have. In fact, it would probably be the largest commercial label that we would have, similar label we would have to date. If you look at it by the numbers, it's about 20,000 patients with about 18,000 of those drug treated, and about half of those which are cisplatin eligible. This is a real meaningful opportunity for the teams. Our next question comes from Jessica Fye from JPMorgan. Please go ahead with your question. Great. Good afternoon. Thanks for taking my question. For PADCEV, can you talk about how much growth you see remaining in the U.S. in the existing approved indications? Recognize that you're obviously embedding growth for the product this year, but I guess I'm talking about ultimately how close are you to fully penetrating the lay line opportunity? Thanks, Jess. The brand will continue to grow in the existing indications, albeit at a slower rate. The big opportunities are going to be moving up into earlier lines of therapy. Our next question comes from Jay Olson from Oppenheimer. Please go ahead with your question. Hey, thanks for taking the question. Maybe I'll shift gears over to HER2-positive breast cancer. Can you just talk about your latest thoughts on the competitive landscape, especially with regards to ENHERTU and also, how do you expect DV to differentiate from ENHERTU as well? Also maybe, any perspective on TUKYSA in terms of the competitive landscape. Thank you. Hey, Jay, it's David. I'll give some introductory color, then I'm gonna ask Roger and Chip to add to that. You know, clearly the breast cancer market is pretty dynamic right now. The introduction of ENHERTU, which is a very good drug, has shaken things up a bit. People seem to get, you know, durable responses on that medicine, and it causes drug developers to think carefully about, you know, how they would bring additional or perhaps even still better drugs into that marketplace. In the case of DV, my, you know, initial thinking, and Roger will add some more, is that there's an opportunity to come in behind ENHERTU, largely because we have a different payload and a very, very good drug. As you know, breast cancer patients will go through, you know, multiple lines of therapy during the course of their treatment. In the case of TUKYSA, where we're differentiated as a small molecule, with really good data and benefit in patients with brain metastases. Our strategy there is to, as you know, combine TUKYSA with other drugs. We have a trial underway which we'll report out in the not-too-distant future, combining TUKYSA with Kadcyla. Kadcyla, that will then, you know, expand, perhaps roughly double the size of the patient population that would be eligible for a TUKYSA, Kadcyla containing regimen. You can think of TUKYSA as currently a brain mets drug, and Kadcyla being used, you know, really for visceral mets. Now a doctor can use a combination to treat that entire set of patients. That gives you just some color. It's one of the more difficult markets to forecast at the moment. You know, we can chat some more about that. Roger, do you want to add anything about it from a clinical standpoint? I would just add, David, I think again, yeah, agreeing with your statements. ENHERTU is a great drug. It's making a difference. It's actually defined a population in breast cancer that is sort of previously not defined, which is a HER2-low population. You know, we're excited about disitamab vedotin. You know, having that defined population ahead of us, we see an opportunity. Once patients have gone to a sort of chemotherapy-based type of therapy, I don't think we see any difficulty with physicians and patients accepting that, you know, they could go from one ADC to another. As you point out, there are different payloads. We have a different antibody. Ours is not trastuzumab. It's a proprietary antibody directed against ENHERTU. We're still working on those development plans. I would also point out that, you know, and we believe this pretty strongly, one of the hallmarks perhaps of a vedotin-based ADC is in the context of an immunotherapy like a PD-1 inhibitor. We believe we may potentially have a leg up where that combination, as you can see with our PADCEV/KEYTRUDA data, really has an impactful outcome. You know, any development plans we think about for DV, we think about the possibility of combining with a PD-1 inhibitor. As you mentioned, we have tucatinib as well. You know, combining those assets are also in our plans. Great. Thank you very much. Our next question comes from Stephen Willey from Stifel. Please go ahead with your question. Thanks for taking the question. I guess just on B6A, I know that you're talking to an update in the first half of this year. I think you're kind of emphasizing durability of responses that have been observed to date. Should we expect any additional dose expansion data along with that update? To what extent does the dose that you've selected for dose expansion in head and neck inform the dose and schedule that you want to take forward into lung? Thanks. Stephen, let me start, and then I'll ask Roger to follow up and more specifically answer your question. Let me just say, you know, we have a lot of experience in this company with vedotin ADCs. You know, when we see early data across different dosing cohorts in a disease, we have a pretty good read. It's not foolproof, but a pretty good read on where a product is likely to go. Let me just say, you know, SGN-B6A is shaping up to become a transformative asset for this company. We're very excited about it. There will be data cuts later this year, which we'll be sharing. Roger, any more thoughts? Sure. It's a great question. Obviously, I think we'll hold the details until we get to present. What I would say in general is that we will land on one dose and schedule regardless of the disease. You know, the cross-information or the flow of information from one expansion cohort to the other is a coordinated event in terms of us trying to land on what we consider to be an optimized dose and schedule. As David said, we look forward to sharing, you know, durability data and its potential for the data cuts in the year as well. All right. Thanks for taking the question. Our next question comes from Geoff Meacham from Bank of America. Please go ahead with your question. Good afternoon. This is Hao calling in for Geoff Meacham. Thank you for the question. I think my question is related to ADCETRIS. Again, a very strong quarter. I think you cited about price, COVID, and penetration as momentum there. Just wanted to get a sense about how does this you see in 2023. Do you see that sort of trend to continue in 2023? Hi, Hao. It's David. Let me just say, you know, in Todd's commentary, we mentioned that this product will become a blockbuster in our territories, which is the U.S. and Canada. Typically, when brands start to accelerate because of new labels and new guidelines, they maintain that acceleration for a period of time. It's our thinking that, you know, 2023 will be another strong year for the brand. Our next question comes from Gregory Renza from RBC Capital Markets. Please go ahead with your question. Great. Thank you very much for taking the question, and congrats on the quarter and the progress so far. David and team, just maybe a question and a request for your renewed thoughts on really the path to profitability. Just curious as you have prioritized, certainly the pipeline programs, doubling down on the commercial portfolio, how you think about the investments that you're committing to and just that ramp there as it relates to looking at these early programs that you believe have a high probability or a better probability of success as it pertains to looking at profitability. Thanks so much. Yes, I'll start, and then Todd will follow up. I mean, the short answer is, at the JPMorgan meeting, Healthcare Conference meeting, and in this call, we're highlighting three global or near globally owned assets, each of which can be a blockbuster. Just to put that into context for you, non-small cell lung cancer for B6A is a market that's, call it, six times the size in terms of epi than the first-line PADCEV bladder cancer market. We're talking about really tremendous opportunities for our company. The way I think about these things is our first priority is to invest adequately, in terms of, you know, having the breadth of pivotal trials necessary to capture those huge upsides. Obviously, you know, we're very thoughtful about how we spend our cash. Balance sheet is strong. When we do get the profitability, I would suspect it's not going to be, you know, eking out minor profits, but would be, you know, profits that really matter. They would become substantial. Anything you'd wanna add? Yeah, maybe just one thing. Thanks, Greg, for the question. You know, if this is first of all a question that we've gotten for a long time, and it's a good question. It's one we stare at. I think our strategy continues to be investing in our portfolio and our platforms to bring more meaningful drugs to patients in need. I think if you just look at last year's print, you know, our revenues were up about 25% for the quarter and the year. When you look at the 2023 guide, even excluding Cohort K, we're up about 15%, and this brings our total revenues to $2. 25 billion, just about. I think that's an illustration of how successful we think the strategy has been. With that in mind, we've got an amazingly broad and deep pipeline to continue investing in. You heard a little bit on the call today about programs like SGN-B6A and BV and B7-H4. These are drugs that, you know, address meaningful solid tumor populations, and they're assets that, for all intents and purposes, are wholly owned by Seagen. We think those are the types of assets that make a lot of sense for us to invest in and invest in heavily to really continue to drive the growth and the success that we've had today. I think just to add to that, said in another way, I think what Todd just told you was we could get profitable pretty soon if we wanted to, but we would be cutting off our future, which is much more exciting than where we are today. Agreed. That's great. Thanks, guys. Our next question comes from Michael Schmidt from Guggenheim Securities. Please go ahead with your question. Hi, good afternoon. This is Yige for Michael. Thanks for taking our questions. One question on PADCEV. You previously reported medium treatment duration of 11 cycles for PADCEV/KEYTRUDA combo in Cohort K. Is that a good modeling assumption for PADCEV duration in first-line fit eligible patients in clinical practice post-approval as we're nearing the PDUFA date in April? How could this number still change with longer follow-up as there were still roughly one third of the patients still on treatment by the last data cutoff? Thank you. We are very excited about this upcoming FDA decision with the April PDUFA date. I'm gonna ask Chip to try to give you a little bit of thinking about how long we think patients might be on therapy. One thing I would say to you is that they will be on therapy longer in the front-line setting than in the second-line setting, in part because these patients are generally healthier, in part because the dose density is probably a little bit less. All told, patients should do better when this drug is combined with KEYTRUDA, given the synergies that we see between vedotins and anti-PD-1s. Chip, any more thinking you'd wanna add? Yeah, sure, David. I think it's just important to note we don't have a label yet, so certain details on this could change. Our general thinking with regard to the clinical trial experience we have is that we would expect to see a longer duration than what we do in second line. The duration in front line we think is gonna be somewhere closer to seven months. As David mentioned, it's a little bit less of a dose-dense regimen on a monthly basis, and the patients are also, generally speaking, a little bit fitter. We think that's kind of what we're looking towards. Great. Thank you very much. Our next question comes from Andy Hsieh from William Blair. Please go ahead with your question. Great. Thanks for taking my question. David, congrats and great to hear from you. I am just curious about the biology and underlying clinical characteristics of first-line fit eligible patients versus, let's say, second or third line as you enrolled in the EV-301 study or the initial accelerated approval. I'm just curious, is it beyond the realm of possibility to receive a broad label as the FDA reviews the PADCEV in front-line UC? I am going to punt this one to Roger. Let me just say to you know, you gave me a nice opening there, compliment. Let me just say that, I'm really happy to be at Seagen. I'm about three months in right now. I'm even more bullish on the future of this company, you heard some of that in the call. You know, strong in line growth, B6A shaping up to be a transformative asset, leading position in bladder cancer. Although we haven't been asked yet, we have a discovery team that's getting ready to file this year IND with a campto payload. This company is really on the move. Now for your specific question, Roger, what do you think? Sure. Hey, Andy. Thanks. It's, it's an interesting question. I think I. You know, our view is essentially, you know, we get we hope we get what we ask for. As David said, the review is going well. The population is well-defined as cis- ineligible based on characteristics of things like renal dysfunction, and hearing loss. We have right behind it, you know, EV-302, which we've signaled we'll have, you know, top line data, you know, sometime in this year, towards the end of the year perhaps. I think I, you know, although it would be fantastic, I think it would be very unlikely. My personal view is if we're successful, the likely outcome is the label will reflect the population we studied, which is cis- ineligible patients. Got it. Very helpful. Thank you. Our next question comes from Joe Catanzaro from Piper Sandler. Please go ahead with your question. Hey, guys. thanks for taking my question and congrats on the progress. Roger, you just mentioned EV-302. With enrollment now complete, I was wondering if you had any visibility into the extent of avelumab maintenance usage in the control arm and how you think about how that may impact the potential performance of the control arm in that study. Roger? Yep, sure. Thanks Joe for the question. Just to give you a little bit of history, if you recall, avelumab went through its approval process, as we were rolling out, you know, EV-302. It is, you know, obviously part of the care of patients with frontline disease, provided they have, you know, either a response, complete response, partial response, or have, you know, disease control, meaningful disease control. The population that actually gets avelumab is relatively restricted compared to the population that we're looking at, you know, on EV-302. Nonetheless, they will be used. I can share with you what that level will be. It is a global trial, so EV-302 has been conducted around the world. You know, if physicians on the control arm consider that avelumab should be used, you know, that likely will happen. I can say there is avelumab use. I just can't give you any more detail as to how much. With regard to the outcomes, I mean, obviously, the trial itself will demonstrate in the end what, you know, the value in terms of things like overall survival and progression-free survival is with PADCEV and KEYTRUDA. I would remind you we have done... Although they are single-arm experiments, we have done two experiments through the form of Cohort A and Cohort K, you know, in a population of cis in eligible patients that are generally perhaps not as well as and older than cisplatin-eligible patients. The survival curves we've generated from there give us, you know, optimism and confidence that if we repeat that type of outcome in the context of a broad global trial, which includes all of these different populations and a degree of avelumab use. I mean, again, We're optimistic. We're excited about the combination. Until the trial reads out, I can't tell you what the results will be, but I think we have a good shot at a positive outcome. Okay, great. That's helpful and, thanks for taking my question. Our next question comes from Andrew Berens from SVB Securities. Please go ahead with your question. Hi. Thanks for squeezing me in, congrats on the quarter. I know you're unable to promote first line for PADCEV until you get a label, I'm just wondering if you're already seeing some usage following the presentation of the data set. Some of our doc checks suggest that they're already using it in the first line already. I just was wondering if you could, you mentioned developing some novel ADC technologies. Wondering if you could let us peek under the covers and see and give us an idea of what you're looking at. First I'll just ask Chip, any sense of whether or not PADCEV may be already used in the first line bladder cancer setting? Yeah. That would be organic. We don't promote to that, obviously. There's been a little bit, but not much. It's minimal right now. Yep. You asked for, to hear a little bit more about our discovery efforts. you know, at JPMorgan, we talked about multiple waves of therapies and technologies. We were, I would say, purposely superficial so as to not give too much away. I indicated in one of my answers already earlier today that we are filing our first, you know, campto-based payload INDs. That's certainly one area we'll be coming to in the very near term. We have a number of other proprietary targets that we think will be particularly suitable for our current vedotin technology. I'll go a little further and just say we are now working on what we believe could be better linkers as well as payloads that are quite different from anything you've seen so far. There's quite an expertise into our, in our discovery group. Roger, as you know, recently became head of R&D, and we're working to prioritize where we focus. There's actually many. Process of now choosing the assets, which we will heavy up on the resources to get them into the clinic. Great. I appreciate it. Congrats again. Thank you. Thanks, Andy. I think we have time for one... maybe one more question. All right. Operator. Our next question comes from Dane Leone from Raymond James. Please go ahead with your question. Hi, thank you for taking questions, and congratulations on the updates. One for me, if you will. With regards to the readout that we could expect for HER2CLIMB-02, you know, it's interesting. It's obviously a larger study, well-controlled, just tease out a signal of the benefit to tucatinib with ado-trastuzumab emtansine. The question that I think a lot of people have is, what are the actual expectations statistically that your team put in place to tease out a PFS signal in this study? Is your expectation that that PFS benefit would come primarily from tucatinib's ability to address brain mets and progression on intracranial disease? Is your team ultimately looking for a bigger PFS hurdle more broadly from the synergy of the two agents? Thank you. Hey, Roger, do you wanna start on that one? Sure. That's an interesting question. just to remind you or sort of set the scene for you on HER2CLIMB-02, it has the same essential design elements as HER2CLIMB. Importantly for this population, obviously Kadcyla is a well-known drug. It is used in second line and plus, and as David said, focusing on metastatic disease. As we did with HER2CLIMB, the eligibility criteria allow patients with brain mets either controlled or active. So we expect to have a meaningful number of patients with brain metastases in HER2CLIMB. Obviously, as we did in HER2CLIMB-02, as we did in HER2CLIMB. With regard to assumptions around treatment effect, just to remind you again of the design, this is a simple add-on design. This is the addition of tucatinib, you know, to Kadcyla. Any, you know, any benefit that tucatinib accrues, I think will be pretty evident. I can't share with you know, specific assumptions, but we are looking for all of the above. If you mentioned, are we looking for treatment effects in a broad population? Yes. Are we looking for meaningful treatment effects in a subset of patients with brain metastases? The answer is yes. I think we see the potential for tucatinib, instead of being an or decision. In other words, for physicians, if this trial is positive and the results are meaningful, physicians will, and patients, be able to make the decision if Kadcyla is part of the treatment plan, you know, to add tucatinib to that combination. Great. Thanks, Roger. Let me just conclude by saying this is gonna be a very exciting year for us. Many data and regulatory milestones. I'm thrilled to be here, and I thank you for, you know, all the attention you're paying to our company. With that, we'll close the call. Ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We do thank you for joining. You may now disconnect your lines.