Good afternoon, and welcome to the Seagen Third 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. 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, Vice President of Investor Relations. Please go ahead. Thank you, operator, and good afternoon, everyone. I'm pleased to welcome you to Seagen's Third Quarter 2021 Financial Results Conference Call. This afternoon, we issued a press release with our results, and the press release and supporting slides are available on our website in the Investors section, Events and Presentations page. Speakers on today's call will be Clay Siegall, President and Chief Executive Officer, Todd Simpson, Chief Financial Officer, Chip Romp, Executive Vice President, Commercial U.S., and Roger Dansey, 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 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 Seagen is contained under the caption Risk Factors included in the company's quarterly report on Form 10-Q for the quarter ended June 30, 2021, 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 Clay. Thank you, Peg. Good afternoon, everybody, and welcome to our third quarter call. We look forward to providing updates today on recent commercial, regulatory and clinical achievements. We reported net product sales of approximately $1 billion for the year to date and $366 million for the third quarter, reflecting growth across our expanded portfolio of approved medicines. We continue to demonstrate robust financial strength fueled by product sales, royalties, and multiple strategic collaborations. Our strong balance sheet allows us to advance and expand our pipeline both internally and through external business development efforts that you will hear more about shortly. Our first strategic priority is to maximize the global potential of our products through exceptional commercial execution, clinical development, and strategic partnerships. We've expanded our commercial portfolio from one product to four in less than two years, which is a remarkable achievement by our team. Last month, FDA granted accelerated approval to tisotumab vedotin or TIVDAK, a tissue factor-targeted antibody drug conjugate, which we are co-developing with our partner Genmab. TIVDAK is the first and only FDA-approved ADC for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Upon its accelerated approval in September, TIVDAK became Seagen's fourth commercial product and marks an important milestone for women with recurrent or metastatic cervical cancer. We are focused on strong commercial execution and early launch feedback has been positive. We are also conducting a broad clinical development program intended to expand TIVDAK's future potential and support global regulatory applications. Although the initial indication represents a modest market, we have already presented promising data investigating TIVDAK in combination with other therapies in earlier lines of cervical cancer, which may represent important clinical advancements and much larger market opportunities. TUKYSA, our best-in-class HER2 tyrosine kinase inhibitor, has become an important option for the treatment of second and later-line HER2-positive breast cancer patients with and without brain metastasis. TUKYSA is approved in 36 countries, and in addition to the U.S., we have commercially launched in Germany, France, Switzerland, and Austria. A year and a half after U.S. approval, we are pleased with TUKYSA's uptake, healthcare provider feedback, and inclusion in key treatment guidelines. We continue to engage with European authorities to secure broader reimbursement for TUKYSA, which could take up to two years depending on the country. Our strategic collaboration with Merck will help further accelerate TUKYSA's global reach in regions outside of the U.S., Canada, and Europe. We believe TUKYSA has broad potential in HER2 cancers, and to that end, we recently completed enrollment in the phase II MOUNTAINEER trial in advanced HER2-positive metastatic colorectal cancer, which could potentially support registration under FDA's accelerated approval pathway. TUKYSA's broad clinical development program also includes evaluation in HER2-positive breast cancer, gastric cancer, and other HER2 amplified or mutant tumors. PADCEV is a first-in-class ADC that has quickly become standard of care in previously treated metastatic urothelial cancer. Earlier this year, FDA granted PADCEV a second indication, making it the first and only FDA-approved therapy for patients with locally advanced or metastatic urothelial cancer who have received immunotherapy and cannot receive cisplatin. PADCEV also received regular U.S. approval, enabling us to promote the impressive overall survival data, a key benefit we have also been able to leverage with ADCETRIS and TUKYSA. Outside of the U.S., Padcev recently received approval in Japan, and we and our partner Astellas continue to make progress with global regulatory submissions across Europe, Asia-Pacific, and the Americas. We have positioned Padcev strategically to benefit from changing urothelial cancer market dynamics, and we are advancing a robust clinical development program. Notably, we recently completed enrollment in cohort K of the EV-103 trial evaluating Padcev in combination with Keytruda as first line treatment in patients with metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy. The results of this cohort could potentially support registration under FDA's accelerated approval pathways. Lastly, Adcetris, the foundation of care in multiple CD30 expressing lymphomas, is commercially available in 76 countries along with our partner Takeda and is a key part of our core business. A decade after approval, Adcetris maintains solid performance with record quarterly sales and will be featured in multiple abstracts at ASH in December. We continue to progress a comprehensive clinical development program to maximize Adcetris' potential to benefit patients. Our second strategic priority is to advance our programs towards securing approvals for new products. In August, we added a late-stage asset to our pipeline through an important license agreement with RemeGen for disitamab vedotin or DV outside of RemeGen's territory of Asia, excluding Japan and Singapore. DV is a novel ADC that is active across a broad range of HER2-expressing solid tumors and is being developed as monotherapy and in combination with PD-1 inhibitors. DV has already received conditional approval in China for third-line gastric cancer, and their National Medical Products Administration accepted the supplemental biologics license application for second- and later-lines of metastatic urothelial cancer. The deal represents a strong strategic fit as it harnesses our ADC technology, expertise, development experience, and our expanded global infrastructure. These elements will help to maximize DV's potential value and global reach. We believe DV is an important and differentiated asset, and Roger will go into further detail. Our third strategic priority is to expand our deep and diverse early-stage pipeline through innovation encompassing ADCs, immuno-oncology agents, corporate development, and strategic partnerships. Importantly, we are submitting at least two INDs for additional ADCs, including those targeting B7-H4 and PD-L1, further bolstering our early-stage pipeline. Across our early and late stage pipeline, we are advancing 13 programs in a range of solid tumors and hematologic malignancies, including 4 novel programs that are expected to enter the clinic next year. Next, I'll turn the call over to Todd, who will discuss our financial results. Then Chip will provide an update on our commercial performance. After that, Roger will provide further detail on our clinical development activities and pipeline. Todd? Thanks, Clay, and thanks to everyone for joining us on the call this afternoon. Our financial results reflect significant advances made across the business. Today, I'll summarize our financial results for the third quarter and year to date, and then discuss our outlook for the remainder of 2021. Total revenues were $424 million in the third quarter and $1.145 billion for the year to date in 2021. Product sales totaled $366 million in the third quarter, representing 37% growth over the third quarter of last year. This was driven by growth in product sales across our portfolio. In addition, third quarter results for Padcev included $7 million in sales to another company for a combination clinical trial that they are conducting. Given the growing interest in the use of our drugs in combination settings, we are pleased to see this and wanted to highlight the impact on Padcev sales growth this quarter. Lastly, TIVDAK was launched late in the quarter, bringing a fourth product to our commercial portfolio. Royalty revenues were $41 million in the third quarter and $105 million for the year to date in 2021. Growth over 2020 reflected increasing sales of Adcetris by Takeda, as well as higher royalties on sales of Polivy by Roche and Blenrep by GSK. Collaboration revenues were $17 million in the third quarter and $24 million for the year to date in 2021. Third quarter revenues reflect the achievement of a regulatory milestone under our ADC collaboration with GSK, as well as sale of product supply to one of our collaboration partners. Cost of sales was $83 million in the third quarter and $225 million for the year to date in 2021. This included product cost of sales and royalties for each of our brands, the PADCEV gross profit share to Astellas, and non-cash amortization of acquired technology costs for TUKYSA. R&D expenses were $459 million in the third quarter and $924 million for the year to date in 2021. These are increases over 2020 as third quarter expenses included the $200 million upfront payment due to RemeGen for the licensing of disitamab vedotin, as well as continued investment across our early and late-stage pipeline. SG&A expenses were $180 million in the third quarter and $505 million for the year to date in 2021. These are increases over 2020, reflecting investments to support ongoing TUKYSA launches across Europe and more recently, the launch of TIVDAK in the U.S. I'll now provide several updates to our financial outlook for the remainder of 2021, beginning with product sales. We are increasing our 2021 product sales guidance for all three brands. ADCETRIS sales are now expected to be in the range of $700 million-$710 million, PADCEV in the range of $330 million-$335 million, and TUKYSA in the range of $315 million-$325 million. Chip will provide more context on market dynamics later. We are increasing our 2021 guidance for royalty revenues to a range of $140 million-$150 million, primarily reflecting stronger sales of ADCETRIS by Takeda in its territory. We are increasing our 2021 collaboration revenue guidance to a range of $25 million-$30 million. Turning now to expenses, we are increasing R&D expense guidance to $1.19-$1.24 billion, primarily as the result of the $200 million upfront amount due under the RemeGen collaboration. We are also increasing our cost of sales guidance to a range of $295-$315 million, primarily reflecting higher sales of Padcev. Lastly, we are narrowing our SG&A guidance to $675-$725 million. Non-cash expense guidance remains unchanged. We ended the quarter with $2.4 billion in cash and investments. This does not reflect the $200 million payment to RemeGen made in the fourth quarter. Our financial strength allows us to continue investing in our pipeline and business, and we're pleased with the progress so far this year. Now I'll turn the call over to Chip for an overview of our commercial performance. Thank you, Todd. Performance across the commercial portfolio was strong in Q3. Adcetris, PADCEV, and TUKYSA all delivered growth in the quarter, and we are pleased with the approval and launch of TIVDAK, our fourth product. Adcetris third quarter sales were $185 million, a 13% increase over Q3 2020. We continue to focus on the landmark 5-year ECHELON-1 progression-free survival data in front line Hodgkin lymphoma. These are meaningful data to physicians and patients and solidify the Adcetris regimen as the best option for front line stage three or four patients. August marked the 10-year anniversary of the first Adcetris approval, and I would like to thank the dedicated commercial teams that work diligently to ensure this important product gets to appropriate patients. Moving on to PADCEV. Third quarter sales were $95 million, a 54% increase over the third quarter of 2020. Physician adoption of checkpoint inhibitors for post platinum maintenance continues to increase, and this has generated more addressable patients for PADCEV. We are also promoting to the additional indication for patients who are ineligible for cisplatin-containing chemotherapy and continue to see incremental uptake. Transitioning to TUKYSA, third quarter sales were $87 million, representing a 104% increase over the third quarter of 2020. This marks our fifth consecutive quarter of sequential growth with contributions from the U.S. and Europe. In patients with brain mets, TUKYSA is the most utilized product in second and later lines in the U.S. In Europe, we continue to be pleased with uptake. The demonstrated overall survival benefit from the HER2CLIMB trial, along with favorable clinical guidelines, gives us confidence as we seek reimbursement in additional European countries. Finally, we are excited that TIVDAK has launched, and we are pleased with early reaction from oncologists, and we look forward to continuing to work closely with our partner, Genmab. We are utilizing our well-established support program, Seagen Secure, to help navigate TIVDAK's eye care requirements. TIVDAK provides an important new medicine for patients in the second and third line setting, where previous options have typically offered low objective response rates and poor outcomes. I look forward to providing more details on TIVDAK as we get further into the launch. Now, I'll turn the call over to Roger. Thank you, Chip, and good afternoon, everyone. I'm happy to share recent clinical development updates for our approved medicines and our pipeline. I'll begin my remarks with TIVDAK, which is approved for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Approval was based upon data from the innovaTV 204 trial as well as other supportive studies. A global phase III trial in cervical cancer, innovaTV 301, is currently enrolling a similar population and is intended to serve as the confirmatory trial in the United States and to support global regulatory applications. Our next goal is to bring TIVDAK into early lines of metastatic or recurrent cervical cancer. For that purpose, we are conducting the innovaTV 205 trial in the first- and second-line setting. Combination data from innovaTV 205 were recently presented at ESMO. The combination of TIVDAK and carboplatin in the first-line setting resulted in a confirmed overall response rate of 55% with a complete response of 12% and a duration of response of 8.3 months. In the second-line setting, the combination of TIVDAK and Keytruda resulted in an ORR of 38% with a median DOR of 13.8 months. We are encouraged by these data, which will inform a TIVDAK-based combination approach for frontline cervical cancer. In addition, the recent accelerated approval of Keytruda in the first-line setting further defines the treatment landscape in which a TIVDAK combination will need to be tested. Turning now to TUKYSA. In the evolving HER2 treatment landscape, we continue to progress our broad development program in breast and GI malignancies, as well as other solid tumors. In breast cancer, the phase III trial, HER2CLIMB-02, is evaluating TUKYSA plus Kadcyla versus Kadcyla alone in the first- and second-line metastatic setting. As a reminder, this trial is enrolling patients with active brain metastases with similar eligibility to HER2CLIMB. In high-risk adjuvant breast cancer, enrollment continues in the randomized CompassHER2 RD trial, which is being run by the Alliance cooperative group. This study is evaluating TUKYSA plus Kadcyla versus Kadcyla alone. In GI cancers, as Clay mentioned, we have completed enrollment in MOUNTAINEER, which is assessing TUKYSA and Herceptin as treatment for patients with advanced HER2-positive colorectal cancer. We anticipate results next year, and if the data are compelling, MOUNTAINEER could potentially support accelerated approval in the United States. Additional studies are evaluating TUKYSA in combination with oxaliplatin-based chemotherapy in first-line GI cancers, as well as in a basket trial for solid tumors with HER2 alterations. Finally, we are conducting a study of TUKYSA in combination with Enhertu for HER2-positive breast cancer. I will turn now to PADCEV, where we remain focused on moving into earlier lines of urothelial cancer. In the first-line metastatic setting, we have completed enrollment of EV-103 cohort K, which is testing the combination of Padcev and Keytruda as treatment for patients who are ineligible for cisplatin therapy. This trial is intended to support an application for accelerated approval in the United States, and we expect to report top-line results in 2022. We are also enrolling patients into the phase III EV-302 global trial, which includes both cisplatin-eligible and ineligible patients and is assessing Padcev plus Keytruda compared to platinum-containing chemotherapy. EV-302 is intended to be a confirmatory trial as well as supporting global marketing applications. In muscle-invasive bladder cancer, we, together with Astellas and Merck, are advancing two phase III trials, both of which are testing Padcev in combination with Keytruda. The KEYNOTE-B15 or EV-304 trial is enrolling cisplatin-eligible patients, and the KEYNOTE-905 or EV-303 trial is enrolling cisplatin-ineligible patients. Additionally, we have now opened the EV-104 trial of single-agent Padcev in non-muscle invasive bladder cancer. In this study, Padcev is administered intravesically in BCG non-responsive patients. Nectin-4 is highly expressed in this disease state, and pre-clinical data support this as a potential opportunity for Padcev. We are also evaluating Padcev in a basket trial of high Nectin-4 expressing solid tumors, including lung, breast, head and neck, gastric, and esophageal cancer. This study is enrolling, and we await initial data to inform our next steps. Now on to Adcetris. At the upcoming ASH meeting in December, we expect to have several presentations. Notably, we plan to present data for the first time from an ongoing phase II study assessing Adcetris in combination with nivolumab, doxorubicin, and dacarbazine as frontline treatment for advanced Hodgkin lymphoma. We continue to advance our clinical development program, including ECHELON-3, the phase III trial in relapsed diffuse large B-cell lymphoma, which compares Adcetris plus Revlimid and rituximab to Revlimid and rituximab. Our newest entry into late-stage development is disitamab vedotin, which has already received conditional approval as monotherapy in China for gastric cancer. The antibody, which has a high affinity for HER2 and blocks signaling, also demonstrates enhanced internalization when compared with trastuzumab. This is an important characteristic for an antibody-drug conjugate. The ADC also delivers our proprietary vedotin payload, the same as in our three commercial ADCs. Initial data in metastatic urothelial cancer was impressive and has already garnered breakthrough therapy designation from the FDA. Additionally, PD-1 inhibitor combination data were presented at ASCO this year, demonstrating high response rates, and these will also inform our clinical development plans. We are in active discussions with the FDA on our urothelial cancer development strategy. With regard to breast cancer, our partner, RemeGen, has generated initial encouraging monotherapy data in HER2 low breast cancer, and we are evaluating the potential here for future development. Turning now to ladiratuzumab vedotin or LV, which is being developed with our partner, Merck. At ESMO this year, we presented initial efficacy data with the weekly dosing regimen of LV in patients with triple-negative breast cancer. Data demonstrated that weekly LV results in a confirmed ORR of 28% in the second and third line setting. We continue to evaluate the optimal dose and schedule of LV, both as monotherapy and in combination with Keytruda to optimize efficacy and safety. I'd like to now briefly mention our early stage pipeline. We are advancing seven programs in phase I clinical trials across a range of solid tumors and hematologic malignancies, including the ADCs, SGN-CD228A, SGN-B6A, and SGN-STNV. We expect IND submissions for at least two more novel ADC programs this year targeting B7-H4 and PD-L1. At SITC in November, we will present posters on these programs, which will highlight robust anti-tumor activity in preclinical models. We also have four effector function enhanced antibodies utilizing our SEA technology, including SEA-CD40, CD70, BCMA, and TIGIT. Later this year at ASH, we will be disclosing initial results of SEA-BCMA in subjects with relapsed or refractory multiple myeloma. With regard to SEA-CD40, as previously discussed, we completed enrollment of a cohort of patients with pancreatic cancer. We expect to report clinical data from this cohort early next year. We have also initiated a basket trial to assess SEA-CD40 in other solid tumors, including melanoma and non-small cell lung cancer. In closing, we continue to reach important development milestones and make meaningful progress with our pipeline, and we look forward to providing you with further updates on future calls. I'll hand the call now back to Clay. Thank you, Roger. Seagen has a resilient core business and solid foundation, which fuels our ability to continue expanding and evolving our capabilities, technology, and business. Throughout this year, we have achieved multiple important milestones. We have a strong portfolio of approved medicines and a proven commercial engine, which allows us to compete in the global marketplace. We have robust clinical development capabilities and a deep pipeline of tomorrow's potential first and best-in-class therapies. Strategic partnerships, our international infrastructure, and substantial financial power enables our ability to develop, advance, and launch exceptional oncology therapies. The future for Seagen is exciting, and we remain passionate and committed to improving the lives of cancer patients worldwide. Operator, please open the line for Q&A. We will now begin the question and answer session. To ask a question, you may press Star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press Star then two. At this time, we will pause momentarily to assemble our roster. Our first question will come from Geoff Meacham of Bank of America. Please go ahead. Hey, guys. It's for Geoff. Thanks for the question. Maybe one for Clay and one for Chip. First off, Clay, now that you have your fourth approved product in the portfolio, maybe talk about how you're thinking about the balance of investing and keeping that early pipeline engine running while also moving toward a sustained profitability. On the TUKYSA launch OUS, maybe just help us understand what the reimbursement pathway looks like over the next 3-6 months or maybe 12 months even as you guys secure different geographies in EU. Thank you. Thanks for the questions. Okay, first of all, we do have four products now. We've had three products approved in the last two years. We're very proud of the products we have that really make a difference in patients' lives. We continue to invest strongly in our late stage, mid-stage, and early stage products. We just submitted two INDs recently that Roger mentioned. We will continue to push forward there. We intend to be profitable. We're not giving guidance today on when we're profitable, but it's something that's important to us. It's also important to us to continue to build our pipeline. We're working together with our board of directors on the future and of Seagen and where we're going, and also working with some of our biggest investors who continue to encourage us to make great medicines and move on. This is the time to do that. We are investing heavily in our pipeline. That is where it is now. Please note we do intend to be profitable. We could be profitable now by, you know, basically not working on our pipeline, not expanding our products. That we don't think is the right way to build a big profitable, self-sustaining organization that makes a huge difference in patients' lives. We're pursuing that. Now, as far as TIVDAK and reimbursement, Chip, do you wanna talk a little bit about the initial- TUKYSA. I'm sorry? TUKYSA. Oh, TUKYSA. Oh, I'm sorry. TUKYSA, sorry. Go ahead. Sure. As far as the ex-U.S. goes, launches continue with strong uptake in Germany and France. We're working through the submittal process for the next countries that are in line. We're in price negotiations with several of them. As we move forward, we look forward to expanding the footprint of reach for the product. Okay, great. Thanks, guys. The next question comes from Cory Kasimov of JP Morgan. Please go ahead. Great. Hey, this is Tom responding for Cory. Thanks for taking the question. Maybe just one on the updated revenue guide here. The new numbers seem to imply a sequential downturn in product revenues in Q4. Is that just a little conservatism on your end, or are there other market dynamics that we should be thinking about as we look ahead to Q4 here? Thank you. Thanks for the question. First of all, we are very pleased with our quarterly and year-to-date performance. Our net product sales were up 37% year-over-year in third quarter of 2021. You know, that's great. We have great products that make a difference in patients' lives. We have increased not only the three, our three initial products. TIVDAK is too new for guidance right now. But we also increased our other revenue metrics, which is royalties and partnering. All five of our revenue metrics, we increased. You know, our focus is on the long game, making a difference in patients' lives, expanding our labels, maximizing the potential and reach of our drugs, going worldwide. You know, we're investing in going into a much bigger footprint globally to help more patients. We believe that this is gonna make the company stronger in the not too distant future. You know, it does take some investment to do that, and we're really excited about that. You know, as far as thinking about the fourth quarter, Todd, do you wanna give a little color onto that? Yeah. You mentioned, are we trying to be conservative? We're actually trying to just be as accurate as we can. You know, we recognize that COVID continues to create a lot of just uncertainties. You know, our drug sales fluctuate quarter to quarter. You know, with that in mind, what we've always tried to do is just do the best job we can on annual guidance, and we look forward to giving our 2022 guidance on the next quarterly call. You know, as Clay mentioned, we're really pleased with how the year has gone. You know, second and third quarter in particular were very strong. As a result, we did, you know, a modest up guide in our product sales guidance today, and we're, you know, really pleased with how we're doing. Great. Thank you. The next question comes from Salveen Richter of Goldman Sachs. Please go ahead. Good afternoon. Thanks for taking my questions. Could you just comment on any granularity on the TIVDAK launch at this point? Just timeline updates or what we should expect next on the TIGIT and LV programs? Sure. We are really excited about getting TIVDAK on the market. You know, it's early, but really good feedback. Chip, would you like to talk a little bit about what's it like out there, you know, in the field and what the commercial scene? Sure. We're really pleased with the initial reactions we've had from oncologists. We look forward to continuing to work closely with our partner, Genmab. Physicians are excited about having the option of TIVDAK. It represents the first and only FDA-approved ADC in the metastatic cervical cancer setting. Switching to your second question. Let's start with them one at a time. TIGIT is a product we're really excited about. It's in clinical trials. We think it's differentiated from the other TIGITs out there because of our SEA technology, and that's in trials. LV is also in a number of trials. Roger, can you comment a little bit about TIGIT and where we are and what we're thinking, and then about LV? Sure. Thanks, Clay. With regards to TIGIT, you know, we understand the environment around us. There are lots of other companies working on the TIGIT program for good reason, because the early proof of concept is there. We understand that time is of the essence. We also need to essentially develop TIGIT in the way that we can, if we are differentiated clinically, be able to demonstrate that. I can just say we're working hard on the TIGIT program. We're not ready for prime time yet, but we are moving along expeditiously. With regard to LV, as you know, we have presented multiple data sets now that LV is an active drug, both as a monotherapy and in combination. We're continuing to work hard with our partners, Merck, to see if we can optimize dose and schedule and then move it into a pivotal trial. We're not there yet. Again, stay tuned for more data, as the program unfolds. Thank you. The next question comes from Michael Schmidt of Guggenheim Securities. Please go ahead. Hi, this is Yi Lei on for Michael. Thanks for taking our questions, and congratulations on the impressive results of this quarter. We have a question on TUKYSA. Now that TUKYSA in HER2CLIMB reported positive results in the second-line breast cancer, do you think this will drive the HER2CLIMB-02 study towards enrolling more patients with brain mets? And what proportion of patients do you expect to have brain mets in that study? And perhaps a related question to this, on the phase II study of TUKYSA plus Enhertu, what are you specifically looking at in that study, and what could be the potential next step? Thank you. Thanks for the questions. Two good questions on TUKYSA. Roger, can you start with the brain mets question that they had concerning HER2CLIMB-02? Sure. The next one on Enhertu plus TUKYSA. Right. Sure. With regard to our development program, as you know, we've demonstrated remarkable treatment effects in patients with brain metastases, such a high unmet need. Also, as we know, HER2-positive metastatic breast cancer does have a high frequency of brain mets. Up to 50% of patients will develop brain mets through their disease course. It's expected that a program such as HER2CLIMB-02, where we are allowing patients with active brain mets to enroll, will in fact enroll a decent proportion of patients with brain metastases. We can't share with you any of the information on HER2CLIMB-02 as it is, but just in principle, a drug like TUKYSA, you know, will be attractive for patients with brain metastases. With regard to Enhertu, from a sort of development perspective, the most interesting drugs in the HER2 breast cancer space right now are Tukysa and Enhertu. From a mechanistic perspective, you know, combining an ADC like Enhertu together with Tukysa makes complete sense. As you can see in our development program, we've done that. We've had that same approach with Kadcyla. We're looking forward. We're still in the process of enrolling. We're looking forward to what those results may produce. Of course, if those results are compelling, we will need to think through what next steps there could be. Again, we wouldn't disclose any of that at this point. We're still in the process of data generation. That's very helpful. Thank you. The next question comes from Kennen MacKay of RBC Capital Markets. Please go ahead. Hi. Thank you for taking the question, and congrats on the Q3 performance. I had another question on the guidance, maybe for Todd, just on the increased guide for royalty revenues. I was wondering if you could help us with sort of where we should think about that coming from potentially. Is that coming from Polivy and the label there or whether it's something else? Just maybe going back to the PADCEV guide. After really a quite impressive quarter, 15% quarter-over-quarter growth, just wondering if you could help us understand what dynamics could be at play to then be expecting a decline in Q4 here or whether there's any seasonality. Again, just trying to understand those dynamics. Thanks, and congrats again on the Q3 performance. Thanks, Kennan. Good questions. Let me start with the royalty up guide. As I think I mentioned earlier, the principal reason for that is related to Takeda's sales of Adcetris, you know, stronger than what we had thought of a year ago when we set our guidance. We're delighted to see that Adcetris is doing so well in Takeda's territories. You mentioned Polivy and Blenrep. Those two are starting to contribute to royalties. They're obviously, you know, lower in amount than the Takeda royalties, but it's great to see, you know, the benefit that both these drugs, probably Polivy in particular, and the way that looks like it's moving forward now in the front line. We're really happy with that. On the Padcev guide, you know, I mentioned also that we had a clinical supply order from another company. I wanted to call that out in the remarks I made earlier because while it is $7 million and not that significant to the overall picture, it nevertheless was a pretty meaningful driver of growth in Q3. We did see also commercial growth, so I wanted to point that out. As we look into Q4, you know, it's a situation where Padcev has rapidly become a standard of care. We've now got, you know, both the Cohort one and the Cohort two labels. We're super happy with where we are. There's uncertainty and quarterly fluctuations. You know, we just try to do the best we can across the board actually with all of our guidance, but you know, Padcev as well. Got it. Thank you for that color, Todd. Appreciate it. The next question comes from Boris Peaker of Cowen. Please go ahead. Great. My question is on the Daiichi litigation. I was just wondering if you could comment specifically on maybe on the timing of the arbitration, but also, second scenario is since there's a lawsuit and a trial starting next April, just curious what would happen if you win the arbitration but then lose the lawsuit on the patent litigation? Would they still owe you royalties on Enhertu in that scenario? Boris, thanks for the question on the Daiichi Sankyo legal issues. First of all, as per our guidance, we have said that we believe there'll be the arbitration and the retired federal judge in the arbitration will announce the findings from that before the end of the year. That's something we have been public about. You're right, there is a patent infringement case that we brought forward, which is being heard in April. You are correct on both of those. As far as, you know, really one reading on another, that's you know, basically something we wouldn't comment on. You know, It's an inner workings of the legal system and you know, we have great legal team. We think we have a great case in both regards, both with our arbitration, which is based on our contract that we had with Daiichi Sankyo, and based on the patent infringement, based on issued patent that we have on our technology. They're different cases, they're not the same, and we feel like we have a great case for both. You know, we're looking forward. You know, the most important thing for us is to develop drugs and make a difference in cancer patients' lives, and don't go away from that. It's also, you know, we work with a lot of other companies, and when we work with a company and, you know, we do deals with them, we expect to continue to, you know, if they're using our technology, we expect to be their partner and so that's where this is. Got it. Maybe let me ask a follow-up question not related to the litigation, but I'm just curious, with the strong data that we recently saw for Enhertu versus Kadcyla in breast cancer, how does that impact your development strategy for the, particularly the recently licensed HER2 ADC from RemeGen? Thanks for that. You know, the product from RemeGen, it's really interesting. It internalizes very rapidly. Keep in mind that whether it's the original HER2 ADC, Kadcyla or Enhertu, they both use the same antibody component, which is trastuzumab, which we know as Herceptin. That molecule internalizes, but it's kind of middle of the road internalization. You know, the antibody used in RC48, which is what we licensed from RemeGen, that was a unique antibody, and it was selected based on incredibly rapid internalization. One of the things that we've been able to see based on what RemeGen did with their data, which we did a lot of diligence on, was its impact on HER2 low patients. That's a big area. In fact, it's a bigger area than HER2 high. We think this rapid internalization could be something really exciting. They have data. I mean, they're approved in gastric cancer in China. They have breakthrough designation for urothelial cancer in the U.S. with the FDA. Certainly the data they have in HER2 low breast cancer and other HER2 low tumors is very interesting. They even have data in combination with checkpoint inhibitors, which is not surprising to us since with our other ADCs, they use Adcetris. We see very nice activity with checkpoint inhibitors such as Keytruda. We think all in all, we have a very nice profile there. Yes, Enhertu's a good drug. It's an important drug, you know, and you know, we on behalf of cancer patients, we love when we see new drugs. This is great. You know, that's our goal. It's been my passion and goal for my whole career. I think that there's a lot of room for cancer patients to have different types of therapies. Roger, do you wanna add anything to that? Yeah. I think we're in a fortunate position in that we have a highly valuable and active small molecule TKI, Enhertu, which is in the HER2 space. We now have a HER2-directed antibody with properties that we think are very interesting. We have the external environment, which includes drugs like Kadcyla, which we're combining with, and Enhertu, which we're exploring in combination with TUKYSA. There are lots of possibilities for us going forward. We are not changing our TUKYSA development program as it is right now, but what are the next steps with regard to things like docetaxel, Herceptin in combination with TUKYSA or Enhertu in combination with TUKYSA? I think all of those things are on the table for exploration going forward. Great. Thank you very much for answering my questions. The next question comes from Gena Wang of Barclays. Please go ahead. Thank you for taking my questions. Maybe just follow up on the IP arbitration. I just want to make sure, Clay, would the timing still be 4Q? And how would you share that information with investors? And then, also, you know, another question regarding RemeGen's, you know, the DV compound. I just wondering, you know, how is the data comparison, efficacy, safety, especially say in HER2-low compared to say Enhertu, the ADC profile? Sure. Well, I'll try to take the first part of the question about the arbitration, and then I'll turn it over to Roger to talk about his view of the differences in safety between RC48 and Adotin versus Enhertu. On the arbitration, you know, we feel that we're confident based on where we sit and based on hearing from our internal and external counsel that there'll be a resolution of some type in the arbitration case, not in the patent infringement case, which starts in April, but in the arbitration case prior to the end of the year. That's something that you know, I think you know, would be shared with the investors. We'd probably put out some sort of press release or something like that on it. You know, we look forward to that. Once again, we think we have a strong case. We've been going at this now for some time and look forward to getting it resolved. Roger, on the safety. Sure. With regard to the clinical profile, the data that RemeGen has generated to date looks pretty impressive. It's not that dissimilar from Enhertu in HER2. I think we obviously Seagen need to generate our own data with the population defined as HER2-low, and determine what our next steps are. We see this as a meaningful, a really meaningful opportunity. It may not necessarily be limited to breast cancer. With regards to the efforts that the HER2-low program in China has generated, we will obviously also leverage as much as possible data from China to supplement whatever efforts we make in the United States. Thank you. The next question comes from Andy Hsieh of William Blair. Please go ahead. Great. Thanks for taking my questions, and congratulations on the beat and raise quarter. I have a question about the EV-104 study that you kind of revealed today. So in terms of the intravesical administration of PADCEV, curious how you think about the dosing, since we usually think about that as in a systemic sense. Also for the maintenance phase, also curious about your thinking about stopping dosing at month 10 to 11 versus maybe a longer treatment duration. Thank you. Andy, thank you for those questions. Roger, you wanna take those? Sure. Thanks, Andy. Yeah, we're excited. Yeah, the non-muscle invasive bladder cancer opportunity for PADCEV could be very meaningful. Just to remind you, at least in our hands preclinically, when we introduce PADCEV into the bladder and not expose it systemically, we really expect that the safety profile will look more favorable than systemic therapy. Obviously, we have to generate the data in humans, but the preclinical package supports that, so very little systemic exposure. With regard to dose, it's a great question. You know, the trial has just begun. We are using the current, you know, commercially available PADCEV in mg, and we're hoping that we will be able to define an efficacious dose using that current formulation. That's certainly in our plan. With regard to beyond the initial sort of induction through to maintenance, Andy, I think when we share details of the trial itself to things like poster presentations, I think that would be a good time to address some of those points. Obviously, we're just beginning, so understanding all the way through what our eventual plan, you know, may look like is a little difficult at this point to predict. Operator, we'll take the next question. The next question comes from Jay Olson of Oppenheimer. Please go ahead. Oh, hey, guys. Congrats on the quarter, and thank you for taking the question. Can you talk about your first-line combination strategy that you're planning for TIVDAK? Also, when should we expect to see some data for TIVDAK in other tumor types? Thank you. Thank you for the words about our quarter. You know, we are really excited about TIVDAK. We presented some combination data two different ways at ESMO, and certainly going to earlier lines is very important for us. Roger, do you wanna talk a little bit about that? Yeah. Front line cervical cancer, the standard of care is combination chemotherapy with or without bevacizumab. The recent reveal of Keytruda as an addition to that combination, that adds another layer of drug but actually produces a much better outcome. When you think about how to move into a frontline space and create a regimen that is competitive, that is potentially better than the various current standards of care, we see with TIVDAK as the sort of backbone of that regimen. We believe combining it with chemotherapy, certainly based on the carboplatin TIVDAK combination we've seen, will be an important element. We also believe that pembrolizumab will be an important element. We've shown already the doublets. We need to go further. We need to put into the clinic and test what we would consider to be the final regimen that would be included in a frontline study, and that's exactly what we're doing now. Great. Thank you. Other tumor types? With regard to other tumor types, yes, we are working on a plan to present data publicly at, you know, at an appropriate time. Okay, great. Thank you. The next question comes from Zhiqiang Shu of Berenberg. Please go ahead. Great. Thank you. Congrats on the quarter as well. I'd like to ask about the SEA-BCMA program that you're going to present at ASH. What are we going to see at this initial data presentation? I guess, can you comment on the market opportunity for this drug? Thanks very much. Yeah. First of all, on the market opportunity, this, you know, is in an area that is mainly targeted to multiple myeloma. You know, it's a substantive market. There's great drugs out there like Revlimid and Velcade and, you know, antibodies, CD38, and other drugs. There really is good different therapies out there. But, you know, the disease is certainly not cured at, you know, where it sits. These are therapies that have extended the life of patients. But in MM, there really is still always room for great drugs to come in, especially ones that have very low, you know, safety signals and like what we would expect with SEA-BCMA. Roger, can you talk a little bit about the drug and what was our thoughts on there? You know, obviously as far as ASH goes, until we present, we're not gonna you know, it's not appropriate to talk about the presentation. Roger could give you a little color on it. Sure. The clinical trial program with the SEA-BCMA has been running for a little while now, and we've been evaluating it as a monotherapy, and we've been looking at various ways of dosing it. We've been evaluating it in combination with dexamethasone, which is essentially almost sort of mandatory combination drug in multiple myeloma. It's that type of data in late line myeloma patients that we will be presenting. We obviously, at this point, we believe that the data is mature enough and meaningful enough that it's time for us to produce this in a public forum. We're looking forward to presenting the BCMA initial data. It is initial data at ASH this year. Great. Thanks very much. The next question comes from Reni Benjamin of JMP Securities. Please go ahead. Hey, good afternoon, guys. Thanks for taking the questions, and congrats on a great quarter. Clay, I guess I'd love to just learn a little bit more about the disitamab vedotin and the urothelial data to date. Can you just remind us of that? How should we be thinking about the development plan of this new asset, you know, kinda going forward? Are you guys only gonna be focusing on kinda low HER2 expressing tumors, or is bladder cancer, or do you see a potential option, and how do we think about, you know, Nectin-4 expression versus HER2, and how the two drugs might ultimately work together? Sure. You know, we have not laid out the entire plan at this point for the sacituzumab govitecan. You know, you're touching on a lot of the important things that we considered when we did diligence, when we put it in. Now we have a very big plan that we've been hatching and building up. I don't think you'll have to wait long to really hear everything. Clearly, we're looking at bladder cancer, where there's already breakthrough designation. Clearly, we're looking at HER2-low breast cancer, where there's, you know, a big slug of data. Also, you know, we can't look past gastric cancer. I mean, it's an important cancer. It's already approved in China. There's a lot of different, you know, possibilities for this drug. I think, you know, we're very... We're just well-positioned to take this forward and make it into a real product that could get out on a global scale, not just in China right now. So, Roger, do you wanna comment more about the question? Yeah. With regard to urothelial cancer, the data that's been generated by RemeGen is really impressive. Bear in mind that this is a HER2-defined population, which is something that will need some work in bladder cancer 'cause it isn't a population that has sort of, up to this point, been readily identified. A biomarker-driven population of HER2-high expressers and perhaps the HER2-low group in bladder cancer is the population we're interested in. As Clay mentioned, you know, essentially as this drug comes into our hands, we'll look at all the opportunities in HER2 disease, whether it's traditional amplification or overexpression or HER2-low. I think all possibilities are on the table, but our initial focus is on urothelial cancer and on HER2-low breast cancer. Just as a follow-up, Roger, do you have a sense as to the potential overlap between, you know, that expression, the HER2 expression and Nectin-4? Or are they kind of, you know, maybe a little bit exclusive? Yeah. Nectin-4 expression we see as sort of near ubiquitous. HER2 expression is obviously more limited. I think the epidemiology of urothelial cancer is less well-defined, and that's something that we need to work on. I think when we have a clear and accurate view of the distribution of traditional HER2 high versus HER2 low in bladder cancer or urothelial cancer, we'll bring that forward. It is not the whole population. Obviously, it is a biomarker, a defined group of patients. Perfect. Thanks for taking the questions, and congrats. The next question comes from Joe Catanzaro of Piper Sandler. Please go ahead. Hey, guys. Thanks so much for squeezing me in and taking my question here. Just maybe one quick one from me. Roger, you had mentioned a new basket combination trial for CCD40. Wondering if you could elaborate a little bit on that and maybe how your experience in pancreatic cancer and the combination you're looking at there informed your decision to start this trial. Thanks. Sure. It's a great question. I think we believe strongly in the scientific hypothesis, which is the combination of an agonist, a CD40 agonist, together with agents that injure and kill cancer cells, and potentially also as well together with PD-1 inhibitors that you know relieve the exhausted T-cell population. That as a scientific construct test, we think is really interesting. Obviously, pancreatic cancer is our first foray into that. Pancreatic cancer, as you well know, is not an easy disease to treat. It is, I guess, traditionally considered to be less immune responsive than other tumors, and that's why we're taking the basket trial further into diseases where, in fact, immunotherapy is already proven to work. We think it makes sense to continue, you know, to test this approach in other tumors as well. That's why we're opening up this basket trial, which will include diseases like non-small cell lung cancer, and melanoma. Okay, perfect. Thanks for taking my question. This concludes our question and answer session. I would like to turn the conference back over to management for any closing remarks. Okay. Thank you, operator, and thanks everybody for participating in our call today. Have a good rest of your day. The conference is now concluded. Thank you for attending today's presentation, and you may now disconnect.