U.S. Markets closed
  • S&P Futures

    -26.00 (-0.68%)
  • Dow Futures

    -145.00 (-0.46%)
  • Nasdaq Futures

    -125.50 (-0.99%)
  • Russell 2000 Futures

    -21.10 (-0.96%)
  • Crude Oil

    +0.47 (+0.77%)
  • Gold

    -3.90 (-0.23%)
  • Silver

    -0.19 (-0.73%)

    -0.0010 (-0.0844%)
  • 10-Yr Bond

    +0.0550 (+3.89%)
  • Vix

    +2.57 (+10.66%)

    -0.0001 (-0.0070%)

    +0.0430 (+0.0402%)

    +931.98 (+1.91%)
  • CMC Crypto 200

    -0.91 (-0.09%)
  • FTSE 100

    +61.72 (+0.93%)
  • Nikkei 225

    -800.95 (-2.71%)

Edited Transcript of SGEN.OQ earnings conference call or presentation 11-Feb-21 9:30pm GMT

·53 min read

Q4 2020 Seagen Inc Earnings Call Bothell Feb 12, 2021 (Thomson StreetEvents) -- Edited Transcript of Seagen Inc earnings conference call or presentation Thursday, February 11, 2021 at 9:30:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Charles R. Romp Seagen Inc. - EVP of Commercial U.S. * Clay B. Siegall Seagen Inc. - Co-Founder, Chairman, President & CEO * Peggy Pinkston Seagen Inc. - VP of IR * Roger D. Dansey Seagen Inc. - Chief Medical Officer * Todd E. Simpson Seagen Inc. - CFO ================================================================================ Conference Call Participants ================================================================================ * Andrew Scott Berens SVB Leerink LLC, Research Division - MD of Targeted Oncology & Senior Research Analyst * Cory William Kasimov JPMorgan Chase & Co, Research Division - Senior Biotechnology Analyst * Geoffrey Christopher Meacham BofA Securities, Research Division - Research Analyst * Jay Olson Oppenheimer & Co. Inc., Research Division - Executive Director & Senior Analyst * Kennen B. MacKay RBC Capital Markets, Research Division - MD & Co-Head of US Biotechnology Research * Matthew Kelsey Harrison Morgan Stanley, Research Division - Executive Director * Michael Werner Schmidt Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD * Salveen Jaswal Richter Goldman Sachs Group, Inc., Research Division - VP * Tsan-Yu Hsieh William Blair & Company L.L.C., Research Division - Senior Research Analyst * Xiaozhou Fan Barclays Bank PLC, Research Division - Research Analyst ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Good day, and welcome to the Seagen Fourth Quarter and Full Year 2020 Financial Results Conference Call. (Operator Instructions) Please note that this event is being recorded. I would now like to turn the conference over to Ms. Peggy Pinkston, Vice President of Investor Relations. Please go ahead. -------------------------------------------------------------------------------- Peggy Pinkston, Seagen Inc. - VP of IR [2] -------------------------------------------------------------------------------- Thank you, operator, and good afternoon, everyone. I'd like to welcome all of you to Seagen's Fourth Quarter and Full Year 2020 Financial Results Conference Call. This afternoon, we issued a press release with our results, and that press release and supporting slides are available on our website in the Investors section, Events and Presentations page. Speakers on our call today will be Clay Siegall, President and Chief Executive Officer; Chip Romp, Executive Vice President, Commercial U.S.; Todd Simpson, Chief Financial Officer; and Roger Dansey, Chief Medical Officer. Following our prepared remarks, we'll open the line for questions. We aim to keep this call to 1 hour and to ask that you limit yourself to 1 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 current report on Form 8-K filed with the Securities and Exchange Commission on December 29, 2020, and the company's subsequent reports filed with the SEC. And now I'll turn the call over to Clay. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [3] -------------------------------------------------------------------------------- Thank you, Peg, and good afternoon, everyone. The past year was pivotal in the evolution of our business. We expanded our geographic footprint and operations beyond the United States and Canada, with presence across greater Europe as we prepare for additional launches of TUKYSA. We are now a multiproduct global oncology company with substantial financial strength to fuel ongoing company investments. We have laid a strong foundation for continued growth and the ability to bring important medicines to cancer patients in need. I'll start with a summary of our recent financial performance. We reported record 2020 product sales in our territories of just over $1 billion, reflecting a 59% annual increase. These results were driven by successful PADCEV and TUKYSA launches as well as continued strong ADCETRIS sales. Total revenues were $2.2 billion in 2020, which included royalties and collaborations, notably our new strategic partnership with Merck. We ended 2020 with $2.7 billion in cash and investments, which strongly positions us to continue advancing our programs. In 2021, we expect to see continued growth of PADCEV and TUKYSA and maintain market share for ADCETRIS with anticipated product sales in our territories of approximately $1.3 billion. Todd will walk us through our 2021 guidance, and Chip will discuss the commercial dynamics but first, I'd like to reflect upon the past year. During 2020, we delivered multiple important business, regulatory and development milestones. I'd like to provide you with a few highlights, beginning with ADCETRIS. Our partner, Takeda, gained more ex-U.S. approvals, including in China. Additionally, in December, we presented data from the ECHELON-1 and ECHELON-2 Phase III trials at ASH, demonstrating robust and durable remissions at 5 years. This is a clinically meaningful and important milestone in a cancer patient's journey. We are committed to maximizing ADCETRIS patient reach through our clinical development program in Hodgkin lymphoma and other CD30 expressing malignancies. Next, I'll turn to PADCEV, a first-in-class ADC that we're developing and commercializing in collaboration with Astellas. PADCEV has shown rapid adoption since its FDA accelerated approval for metastatic urothelial cancer just over a year ago. In 2020, we announced positive top line results from 2 PADCEV studies. This included strong data from our single-arm Phase II trial insists ineligible metastatic urothelial cancer patients previously treated with an immune checkpoint inhibitor. We expect to submit these data to FDA in a supplemental BLA within the next few weeks. Last year, we also reported top line results from a randomized Phase III trial in patients with previously treated metastatic urothelial cancer. Results demonstrated that PADCEV significantly improved overall survival and progression-free survival versus standard of care chemotherapy. These data will also be submitted to FDA resulting in 2 concurrent supplemental BLAs in the next few weeks. In addition, global submissions for these trials are planned to support marketing applications in the EU and Japan later this quarter. Also last year, we received breakthrough therapy designation for PADCEV in combination with KEYTRUDA in first-line metastatic urothelial cancer. We are currently enrolling 2 trials designed to support approval in first-line metastatic patients: one, to support accelerated approval in CIS-ineligible patients, and the other to support global approval in patients regardless of platinum eligibility. Our goal is to redefine first-line treatment for metastatic urothelial cancer patients around the globe. Finally, in 2020, we made significant headway in exploring earlier stages of bladder cancer. In collaboration with Astellas and Merck, PADCEV is being tested in 2 randomized Phase III trials in CIS ineligible and CIS eligible muscle-invasive bladder cancer patients. Now on to TUKYSA, a best-in-class HER2 TKI for HER2-positive metastatic breast cancer patients with and without brain metastasis. In 2020, TUKYSA was also approved in the United States as well as Australia, Canada, Singapore and Switzerland under the FDA's project Orbis. In December, we received a positive CHMP opinion, recommending European Commission approval of TUKYSA in the EU, and we are preparing for its potential launch further extending to TUKYSA's reach. Lastly, in order to accelerate the commercialization of TUKYSA in regions beyond the U.S., Canada and Europe, we entered into a strategic collaboration with Merck in 2020. Our 3 currently approved products are important first-in-class or best-in-class medicines that have been embraced by oncologists. We are making substantial investments in their continued development, which will provide growth catalysts in future years. We believe that each of the brands have blockbuster potential. ADCETRIS is a mainstay in the treatment of CD30 lymphomas and has achieved strong market penetration in its 6 indications. Global sales of ADCETRIS in 2020 were approximately $1.2 billion and nearly 83,000 patients around the world have received ADCETRIS therapy. We expect that the impact of COVID-19 which is leading to fewer frontline Hodgkin lymphoma diagnosis will resolve in time, but this is hard to predict. We believe that future growth of ADCETRIS will be primarily based on label expansion supported by our multiple ongoing trials that we expect to read out in the next few years. PADCEV has become the standard of care in its current labeled indication. We expect that both supplemental BLA submissions, if approved, will further strengthen PADCEV's role in the treatment of patients with advanced metastatic urothelial cancer. Looking toward first-line metastatic bladder cancer, we expect to complete enrollment in the cohort K accelerated approval trial by the end of this year. Factoring in a follow-up period to observe duration of response data from this cohort could support a supplemental BLA in 2022. In addition, 3 large Phase III trials are currently enrolling in first-line metastatic urothelial cancer and muscle-invasive bladder cancer. These trials are intended to serve as the basis for multiple global submissions in the future. TUKYSA is an important medicine that has been rapidly adopted by oncologists. We're planning launches in Europe during 2021 as well as seeking reimbursement approvals on a country-by-country basis. Additionally, we're conducting several large potentially pivotal trials in breast, gastric and colorectal cancers. We expect to complete enrollment in the MOUNTAINEER trial in colorectal cancer patients by the end of 2021, while our other studies will continue to enroll. Building on the success of ADCETRIS with our 6 labeled indications, we expect PADCEV and TUKYSA to reach even more patients in the future. This is based on our ongoing extensive clinical development programs that Roger will describe in detail. I'll now turn to our late-stage clinical development programs, tisotumab vedotin also known as TV; and ladiratuzumab vedotin known as LV. Yesterday, we and Genmab announced the submission of a BLA for TV in patients with recurrent or metastatic cervical cancer, positioning it to be our fourth commercial product. This is a significant milestone for Seagen and would further expand our commercial portfolio. We also recently initiated the innovaTV 301 Phase III study in metastatic cervical cancer, which is intended to support global regulatory applications and serve as the confirmatory trial. Aligned with our goal of addressing the high unmet need for patients with hormone receptor positive and triple-negative breast cancer, last year, we announced a global collaboration with Merck to co-develop and co-commercialize LV. The collaboration is intended to accelerate the development of LV and focuses on evaluating this highly active ADC as monotherapy and in combination with KEYTRUDA in LIV1-expressing solid tumors. As we look ahead to 2021 and beyond, we are focused on 3 strategic priorities to drive continued innovation and growth. The first is to maximize the global potential of our 3 approved medicines through robust clinical development programs and exceptional commercial execution. The second priority is to advance late-stage programs towards securing approvals for new products, including TV and LV. And the third is to expand our already strong and innovative early-stage pipeline through continued leadership and innovation in the ADC space, internal R&D investments and corporate development opportunities. Focusing on these strategic pillars will ensure our organization is aligned to deliver substantial value to our key stakeholders, notably stockholders, our employees and especially cancer patients. Next, I'll turn the call over to Chip to discuss our commercial activities. Then Todd will comment on our financial results and 2021 guidance. After that, Roger will discuss our clinical development activities and key milestones for the year ahead. Chip? -------------------------------------------------------------------------------- Charles R. Romp, Seagen Inc. - EVP of Commercial U.S. [4] -------------------------------------------------------------------------------- Thank you, Clay. The commercial team closed out a very successful year with a solid fourth quarter. Launching 2 drugs in these unprecedented times was a difficult task. Through strong digital marketing strategies, creativity and outstanding customer relationships, our team delivered. Successful launches of PADCEV and TUKYSA drove 59% total net product sales growth in 2020 over 2019. I would like to thank all my commercial colleagues for their dedication and efforts in 2020 to ensure appropriate patients received our products. Starting with ADCETRIS, we reported fourth quarter sales of $164 million and $659 million for the year, a 5% increase over the full year in 2019. We continue to see an impact on ADCETRIS sales due to the pandemic. Based on claims and electronic medical records data, new Hodgkin lymphoma diagnosis trends continue to be approximately 15% lower than historic levels. We are now promoting the 5-year follow-up data from the ECHELON-1 trial in frontline HL and early reactions to these important data have been favorable. 5-year outcomes are an established standard, and we expect that the durable advantage of ADCETRIS will drive incremental share. Moving on to PADCEV, fourth quarter sales were $69 million, an increase of 11% over the third quarter of 2020. Full year PADCEV sales were $222 million. We received rapid adoption in our labeled indication, and look forward to promoting upon approval. The overall survival data observed in the EV-301 trial and the strong cohort 2 data in metastatic urothelial cancer. Both indications would meet a significant unmet need for patients who have received a prior PD-1 or PD-L1 inhibitor. Our guidance takes into consideration our high market share in our current labeled indication, and evolving market dynamics, such as increasing use of PD-1 or PD-L1 inhibitors in the front line. We are confident that PADCEV is well positioned this year for continued growth. Transitioning to TUKYSA, fourth quarter sales were $61 million, a 45% increase over the third quarter. Full year sales of TUKYSA were $120 million. We continue to see adoption of TUKYSA across its strong label and payer coverage continues to be solid. We are pleased with the growth we are seeing in both the community and academic settings. I will now turn the call over to Todd. -------------------------------------------------------------------------------- Todd E. Simpson, Seagen Inc. - CFO [5] -------------------------------------------------------------------------------- Great. Thanks, Chip, and thanks to everyone for joining us on the call this afternoon. Today, I'll summarize our financial results for the fourth quarter and full year in 2020. I'll then provide our financial outlook for 2021. Total revenues were $601 million in the fourth quarter and $2.2 billion for the full year in 2020. This included net product sales up $294 million for the fourth quarter and $1 billion for the full year. This is the first time we have recorded net product sales of $1 billion, and this reflects the substantial growth in now a diverse commercial portfolio, which includes 3 important drugs. Royalty revenues were $39 million in the fourth quarter and $127 million for the full year in 2020. Royalty revenues are primarily driven by increasing sales of ADCETRIS by Takeda and, to a lesser extent, sales of Polivy by Roche and BLENREP by GSK, both of which are ADCs that utilize Seagen technology. Collaboration and license agreement revenues were $268 million for the fourth quarter and $1 billion for the full year in 2020. Notably, the full year of 2020 included $975 million related to the LV and TUKYSA deals with Merck, of which $250 million was recorded in the fourth quarter. These collaborations are significant for the company, both financially and strategically and will accelerate the development of LV. Cost of sales in the fourth quarter of 2020 was $62 million and $218 million for the full year. This included product cost of sales and royalties for each of our 3 brands and the PADCEV profit share to Astellas, which was $32 million in the fourth quarter and $105 million for the full year in 2020. In addition, cost of sales included 2 TUKYSA related items, noncash amortization of acquired technology costs of approximately $6 million per quarter that began in the second quarter of 2020, and a sublicense fee that was paid related to the TUKYSA license agreement with Merck. R&D expenses were $216 million in the fourth quarter and $827 million for the full year in 2020. Growth over 2019 primarily reflected increased investment across our pipeline aimed at extending the use of our commercial products through expanded labels, as well as investment in the development of our earlier stage programs. SG&A expenses were $158 million in the fourth quarter and $534 million for the full year in 2020. These are planned increases over 2019 and reflect U.S. commercialization of PADCEV and TUKYSA and our European expansion as we prepare for the TUKYSA launches later this year. Regarding the profit recorded for the fourth quarter and for the full year in 2020. This is the result of revenue recognized under our 2 new collaborations with Merck. Our long-term growth strategy continues to remain on investment to maximize the potential of our approved products and in advancing our pipeline. We ended the year with $2.7 billion in cash and investments, which includes proceeds from the $1 billion equity investment from Merck in the fourth quarter. This positions us strongly to advance our plans in 2021 and beyond. Now regarding our 2021 financial outlook, I'll begin with revenue guidance. First, we expect total revenues to be in the range of approximately $1.4 billion to $1.5 billion. This breaks down as follows. We expect total product sales to be approximately $1.28 billion to $1.34 billion, which includes ADCETRIS sales in the range of $675 million to $700 million, PADCEV sales in the range of $310 million to $325 million and TUKYSA sales in the range of $300 million to $315 million. Clay and Chip provided some context around what we envisioned to be the growth drivers for each of the brands in the near and longer term. Next, with respect to royalty revenues, we expect them to be in the range of $125 million to $135 million, primarily reflecting sales of ADCETRIS by Takeda in its territory and to a lesser degree, contributions from Polivy and BLENREP. Finally, collaboration revenues are now primarily event-driven and dependent upon progress by our ADC collaborators. We expect these revenues to be less than $20 million in 2021. Beginning next year, we expect collaboration revenues will reflect contributions from PADCEV sales by Astellas in its territories. I'll now turn to expenses. Cost of sales is expected to be in a range of $270 million to $300 million. This will be driven by increased product sales across all brands and a higher profit share payment to Astellas as a result of higher expected PADCEV sales. Cost of sales will also reflect third-party royalties owed as well as noncash amortization. R&D expenses are expected to be in the range of $900 million to $1 billion, primarily related to 2 items: First, investment in clinical trials to expand ADCETRIS, PADCEV and TUKYSA into additional indications; and second, increased investment to advance our earlier-stage pipeline that includes 9 other programs in clinical development. We believe that these investments are important to our long-term growth. SG&A expenses are expected to be in a range of $650 million to $725 million as we continue to focus on commercial execution to drive growth of our 3 approved products. This guidance also includes the global infrastructure to support the launch of TUKYSA in Europe. Taken together, our 2021 guidance reflects both that we continue to see significant opportunity for our approved medicines and that we will continue efforts to develop new medicines for unmet medical needs. And with that, I'll turn the call over to Roger. -------------------------------------------------------------------------------- Roger D. Dansey, Seagen Inc. - Chief Medical Officer [6] -------------------------------------------------------------------------------- Thank you, Todd, and good afternoon, everyone. Today, I will provide an update on recent progress for our approved medicines and pipeline programs and will outline key milestones anticipated in the year ahead. Beginning with ADCETRIS, we presented the important 5-year follow-up data at ASH for the Phase III ECHELON-1 trial. ADCETRIS in combination with AVD, resulted in superior long-term outcomes when compared to ABVD in frontline advanced Hodgkin lymphoma. The clinically meaningful improvement in PFS has continued since the primary analysis, reflecting the durable benefits seen with the ADCETRIS regimen. Notably, we also saw fewer second malignancies and more pregnancies in those who received ADCETRIS plus AVD versus those who were treated with ABVD. We are pleased with these aspects of the data in a population of generally young patients with families. Going forward, we continue to see multiple opportunities for ADCETRIS and are advancing trials in Hodgkin lymphoma, PTCL and DLBCL. Most recently, we have begun enrolling a trial evaluating ADCETRIS as an immunomodulatory agent in combination with KEYTRUDA in solid tumors. Turning now to PADCEV. Full results from the EV-301 trial and cohort 2 of the EV-201 trial, both conducted in patients with previously treated metastatic urothelial cancer will be presented tomorrow in oral presentations at ASCO GU. The Phase III EV-301 data demonstrated a clinically meaningful and statistically significant 30% reduction in the risk of death among patients who received PADCEV compared to those who received chemotherapy. In this new era of frequent checkpoint inhibitor use for metastatic urothelial cancer, PADCEV is the first drug shown to reduce the risk of death after patients who received a platinum chemotherapy and a checkpoint inhibitor. PADCEV has also shown a clinically meaningful response rate in patients who were ineligible for cisplatin in the metastatic setting and were treated with a checkpoint inhibitor. EV-301 and EV-201 data will be submitted to regulatory authorities this quarter to support U.S. and global approvals. Another key component of our PADCEV development program is our two-pronged approach to support approval in the first-line metastatic urothelial cancer setting. We plan to complete enrollment of cisplatin ineligible patients receiving PADCEV plus KEYTRUDA in cohort K of the EV-103 trial by the end of this year. And if the data are supportive, a supplemental BLA could occur in 2022 after appropriate follow-up for duration of response. We continue to enroll patients into the Phase III EV-302 global trial which includes cisplatin eligible patients, evaluating PADCEV plus KEYTRUDA compared to a platinum-containing chemotherapy regimen. As we move PADCEV into earlier stages of bladder cancer, we and our partner, Astellas, together with Merck, recently initiated the KEYNOTE B15 or EV-304 trial to evaluate PADCEV in combination with KEYTRUDA in cisplatin eligible muscle-invasive bladder cancer. This trial is in addition to the ongoing trial in cisplatin ineligible muscle-invasive bladder cancer patients, known as KEYNOTE-905 or EV-303. Additionally, we are also in advanced planning for a trial to examine PADCEV administered directly into the bladder in non-muscle invasive bladder cancer patients. Lastly, since the launch of PADCEV, we have continued to monitor the safety of our products in clinical trials and in the post-marketing setting. As a reminder, Nectin-4 is expressed in the skin and rashes common but is generally mild and reversible. Severe rashes, however, do occur and are described in the current U.S. prescribing information. Severe cutaneous adverse reactions, including fatal cases of Stevens-Johnson syndrome and toxic epidermal necrolysis have occurred in patients treated with PADCEV in the post-marketing setting and during clinical trials. With patient safety being our highest priority, we are communicating the occurrence of these rare events rarely though together with updated recommendations to health care providers who may treat patients with urothelial cancer. We are also working with the FDA regarding updates to the U.S. prescribing information to reflect these events. The overall benefit risk balance remains favorable for the use of PADCEV in approved indications. PADCEV provides significant benefit in a high unmet need population with metastatic urothelial cancer, which is further supported by our most recent data showing improvement in overall survival in the indicated population. Moving on, at the San Antonio Breast Cancer Symposium in December, TUKYSA was featured in several abstracts. A key presentation provided new analysis from the pivotal HER2CLIMB trial, demonstrating consistent improvements in progression-free survival, overall survival and objective response rate regardless of whether patients were hormone receptor positive or hormone receptor negative. With regard to our clinical development program, we are excited to be expanding our evaluation TUKYSA into earlier lines of breast cancer treatment and into GI cancers. To this end, we are currently advancing 8 TUKYSA clinical trials, of which 5 have registrational intent. Now I would like to turn to one of our late-stage programs, tisotumab vedotin. For women with metastatic cervical cancer, who progress on first-line treatment, standard therapies typically have low objective response rates of less than 15% and median overall survival ranging from 6 to 9 months. The innovaTV 204 trial demonstrated clinically meaningful durable responses with an ORR of 24% and median duration of response of 8.3 months. And are the pivotal data included in the recently announced BLA submission. We are motivated at the prospect of a fourth approved medicine that could make a meaningful difference to metastatic cervical cancer patients with such a high unmet need. Moving on to ladiratuzumab vedotin, we are working with Merck to accelerate the development of LV, both as a monotherapy and in combination with KEYTRUDA. Our development program includes trials in triple-negative and hormone receptor positive breast cancer as well as a basket trial in 8 other liver and expressing solid tumors. We are making progress on optimizing the dose and schedule of LV and have extended the weekly schedule evaluation to the combination of LV with KEYTRUDA. Turning now to our earlier stage pipeline. We have in the clinic 3 novel ADCs, 2 of which use our vedotin payload; and 4 effector function enhanced antibodies using our SEA technology. Our most recent drug to enter Phase I is our novel ADC, SGN-STNV. This targets Sialyl Thomsen-nouveau, a carbohydrate antigen, which is highly expressed across multiple solid tumors. I would now like to summarize some of the important upcoming milestones that we are looking forward to in 2021. Beginning with regulatory, we have just submitted the TV BLA and look forward to working with the FDA on the application. Additionally, we look forward to hearing from regulatory authorities in Europe on our TUKYSA marketing authorization application. And PADCEV will be submitted to regulators in the U.S., Europe and Japan, by the end of this quarter. Moving to clinical trial activities. We expect to complete enrollment in the pivotal cohort k of the PADCEV EV-103 trial and the pivotal TUKYSA MOUNTAINEER trial by the end of 2021. We have opened the innovaTV 301 global confirmatory trial, and we have the potential to initiate several other pivotal trials across our pipeline in 2021. Finally, we plan to have multiple data readouts this year. This includes data from LV and multiple Phase I programs, such as SEA-CD40 as well as data from TV in solid tumors other than cervical cancer. We also plan to submit multiple INDs for novel product candidates during the course of the year. I look forward to sharing further details and developments as the year progresses. Now I'll turn the call back over to Clay. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [7] -------------------------------------------------------------------------------- Thank you, Roger. I'm proud of the remarkable progress we have made as a company over the past year despite the challenges of COVID. We have set the stage for Seagen's next phase of innovation and execution, and the company has never been stronger and better positioned for growth. We have an expanding commercial portfolio, deep pipeline, broad geographic footprint, powerful partnerships and a focused strategy. This will, in turn, increase our ability to reach more cancer patients globally who need life-saving therapies. I would like to thank everyone listening to this call for your continued interest in Seagen and your ongoing support. Operator, please open the line for Q&A. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) And our first question today will come from Kennen MacKay with RBC Capital Markets. -------------------------------------------------------------------------------- Kennen B. MacKay, RBC Capital Markets, Research Division - MD & Co-Head of US Biotechnology Research [2] -------------------------------------------------------------------------------- Congrats on the progress in 2020. What a year. Maybe just on the guidance for TUKYSA and for PADCEV. Just wondering if there's anything you can comment around what is baked into that in terms of indication expansion or geographic expansion or whether that's all up siding that's just based on the current indication? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [3] -------------------------------------------------------------------------------- Sure. Kennen, thanks for the question. Can you hear me, Kennen? -------------------------------------------------------------------------------- Kennen B. MacKay, RBC Capital Markets, Research Division - MD & Co-Head of US Biotechnology Research [4] -------------------------------------------------------------------------------- Yes. Sure can. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [5] -------------------------------------------------------------------------------- Okay, good. Just want to make sure. You asked questions about TUKYSA and PADCEV. So, first of all, we're really excited that we have 3 approved drugs. And our launch for both PADCEV and TUKYSA has been largely through -- either largely are all through COVID, so we've had to come up with a new way to launch drug. We -- on PADCEV, we're now a standard of care for advanced urothelial cancer patients who've received platinum and PD-1. And so we're in very good shape with that. We've had great progress. Chip, would you like to give a little bit of color on the guidance and what it really reflects? -------------------------------------------------------------------------------- Charles R. Romp, Seagen Inc. - EVP of Commercial U.S. [6] -------------------------------------------------------------------------------- Sure, Clay. So we're monitoring ongoing changes in the marketplace. We're seeing a move of PD-1 and PD-L1 utilization into the front line, which, in essence, has expanded PADCEV's treat location population. So that is a key driver for us in 2021. With regard to TUKYSA, we continue to see increased utilization in both patients with brain metastases and patients without. So we're really focused for 2021 for promoting the full breadth of the label that we have. -------------------------------------------------------------------------------- Operator [7] -------------------------------------------------------------------------------- And our next question will come from Geoff Meacham with Bank of America. -------------------------------------------------------------------------------- Geoffrey Christopher Meacham, BofA Securities, Research Division - Research Analyst [8] -------------------------------------------------------------------------------- I just had a couple of quick ones. Roger, when you look at the PADCEV and first-line opportunity from cohort K, what's the normal duration of response from chemo that you'd expect? And are there ways to win, let's say, on an equivalent ORR, but perhaps better tolerability? And then for Todd or Chip, just also on guidance. Just wanted to ask how much of a continued headwind from COVID is reflected? And is there a way to quantify it or at least tease out which products could be affected? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [9] -------------------------------------------------------------------------------- Jeff, thanks for both of the questions. Let's start with Roger talking a little bit about the frontline PADCEV story where we have actually 2 frontline trials. But I think Jeff is focused on cohort K, but Roger, you can discuss what you'd like to on that frontline trial basis. -------------------------------------------------------------------------------- Roger D. Dansey, Seagen Inc. - Chief Medical Officer [10] -------------------------------------------------------------------------------- Sure. Thanks for the question, Geoff. It's an interesting one. So as you know, the data we've generated with PADCEV and KEYTRUDA is remarkable. It is, of course, a single-arm trial. It's 45 subjects, but we have a response rate that is substantially better than anything one could generate with standard of care. The information around -- so I think our expectation, our hope is that there won't be equivocation on the ORR. Obviously, the data has to play out. With regard to durability, what's really important, as you know, is when you give a PD-1 inhibitor, it's one of the absolute hallmarks, the durability. So as high as the ORR is in the data generated to date, the long-term outcome, such as durability of response and progression-free survival and all are equally remarkable. With standard chemotherapy, PFS is measured in a sort of 7-month period. I don't have a specific number for DOR for you because it's not often reported. But it's hard. Again, if we can recapitulate even to a reasonable degree that better we've generated so far, I think we'll have a compelling story to tell. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [11] -------------------------------------------------------------------------------- And then on the guidance front, Geoff, you're asking a little bit about headwinds potentially with COVID. And certainly, we -- every company would be remiss to say, everything is perfectly normal with COVID there. I mean there was a big article in Fierce Biotech, I think, within the last 2 days about how oncology clinical trials are 60% down in enrollment. Ours are doing well. We're not 60%, but I certainly understand the difficulties of running clinical trials during COVID. Also, we've guided, patients just coming into get therapy, whether it's first-line Hodgkin lymphoma, or older patients coming in with, for example, bladder cancer. So there's certainly some headwinds, but we've done great, I think, really getting our exciting medicines out. Chip, would you like to -- or we'll start with Chip and then, Todd, if you have something you'd like to add, it would be great. Chip, any thoughts on the guidance as per COVID headwinds? -------------------------------------------------------------------------------- Charles R. Romp, Seagen Inc. - EVP of Commercial U.S. [12] -------------------------------------------------------------------------------- Yes. Well, so it's obviously difficult to predict what's going to take place with the pandemic. There's no doubt that it's been a headwind. But I would tell you, the teams have adapted well with regard to our promotional efforts. We've altered a lot of the digital mix that we have from a marketing standpoint. We're putting an emphasis on that. And so we're pleased with the results that we're seeing so far. -------------------------------------------------------------------------------- Todd E. Simpson, Seagen Inc. - CFO [13] -------------------------------------------------------------------------------- Yes, this is Todd. I'll maybe add a couple of thoughts. With respect to ADCETRIS, it's a little bit easier to correlate COVID effect with what's happening in the marketplace. Chip has previously talked about and we've talked about for a few calls now that we're seeing about a 15% reduction in the diagnosis rate of frontline Hodgkin lymphoma. We can get to those data through review of things like electronic medical records. With drugs like TUKYSA and PADCEV, it's a little harder to pinpoint exact causality. But to Clay's point, I think, we're all experiencing a little bit of pain with COVID. Now with that in mind, I think we're all hopeful that we're just about to get behind this thing. It's hard to speculate on when that might happen, but we're hopeful that as the pandemic resolves that things will come back to normal a little bit. -------------------------------------------------------------------------------- Operator [14] -------------------------------------------------------------------------------- Your next question will come from Cory Kasimov with JPMorgan. -------------------------------------------------------------------------------- Cory William Kasimov, JPMorgan Chase & Co, Research Division - Senior Biotechnology Analyst [15] -------------------------------------------------------------------------------- I had one on PADCEV. With the product on the market for a little over a year now, curious if you can tell us more in the average number of cycles you're seeing per patient in the real world, kind of how that's evolving as well as sort of the latest in terms of an annualized cost of treatment per patient? And Roger, you mentioned the rash that you've seen and you've alerted doctors too. Is that impacting things in any material way on the commercial front? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [16] -------------------------------------------------------------------------------- Cory, thanks for the question. As far as the average cycles that we were out there with, we aren't -- I don't think we've really discussed that. We've discussed like how long in general we treat people, but it's really different for a lot of patients and the annualized cost. So we've given some information on that. Chip, would you like to talk a little bit about roughly the cost per patient with PADCEV? And clearly, this is not in the front line. This is in the relapse setting, which is our current label. So Chip, do you have any comments on that? -------------------------------------------------------------------------------- Charles R. Romp, Seagen Inc. - EVP of Commercial U.S. [17] -------------------------------------------------------------------------------- Yes, I do, Clay. So if I were to -- just to kind of ballpark net price associated with this, reflecting gross to net and discounts that are given associated with it would be about $90,000 per patient. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [18] -------------------------------------------------------------------------------- Yes. So thank you. So that's about right. And so when people ask me, I usually somewhere in that $90,000 to $95,000. So it's about really where we are spent on the patient and their size, et cetera. On the question you have on the rash, we -- in our initial USPI, we described skin reactions, including some that are severe. And Nectin-4 is a great target. Nectin-4 binds to tumors like crazy, especially urothelial tumors and some other ones that we're screening, and you'll hear more about that with our basket study, but it also binds like almost every antibody. It has some normal tissue cross reactivity. And so we've known about the skin, and there's some patients that get rash, and we have a section in the warning super cautions. So that doctors are well aware of what this is. And so we call it out. And most of the time, it's nothing to write home too much about. Sometimes it gets more severe. We think that PADCEV has a very favorable risk benefit. And we've shown that through overall survival in the 301 study, which we'll be presenting the data tomorrow. So that's something really to look forward to. When you see an OS benefit in rapid control of the disease, you have to weigh that against any of the side effects of any drug. And we think that doctors are well aware of this, are used to using this. And having the side effects that almost every cancer drug has is, the goal is really to make sure that doctors are aware to try to put it in the best light so that they can watch it. And if there's anything happening with a patient, they could manage it correctly or hold drug or do whatever they need to, and that's the case for all of our drugs because looking at patient safety is number one issue. I don't know if that answered your question? Roger, do you want to put in any thought on this about? -------------------------------------------------------------------------------- Roger D. Dansey, Seagen Inc. - Chief Medical Officer [19] -------------------------------------------------------------------------------- No, sure. And I think Cory's question around does this actually impact duration of therapy. I think Clay has made the right points, which is rash does occur. It's generally mild and transient and does not meaningfully interfere with therapy. For these very rare events, obviously, the drug needs to be discontinued. So any bad reaction would require discontinuation, but the frequency of those events is low. So I don't think we believe that this changes in any way, the way PADCEV is being used or the length of therapy that it's currently used at. -------------------------------------------------------------------------------- Operator [20] -------------------------------------------------------------------------------- And our next question will come from Salveen Richter with Goldman Sachs. -------------------------------------------------------------------------------- Salveen Jaswal Richter, Goldman Sachs Group, Inc., Research Division - VP [21] -------------------------------------------------------------------------------- Given the guidance for PADCEV only includes on label use. Could you help us understand what the incremental market share will be when the additional indication comes on board or indications come on board this year? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [22] -------------------------------------------------------------------------------- Salveen, thank you for the question. And we have 2 submissions. The first one is what we call cohort 2, which is the more frail and weak patients, these were the CIS-ineligible patients. And then the second cohort of patients were -- or the second study that we reported is called our 301 study, which is our global study. Roger can talk about both of those trials. And maybe what they mean. We put out the top line data. Tomorrow will be at ASCO GU. It just so happens it's tomorrow. We wish we could tell you more today, but we need to save it for the presentation at the conference by the investigators. They deserve the right to prevent this. So we're sorry it ends up to be tomorrow, but we'll announce the full data tomorrow and all that, so look for that, and we'll present this. So maybe Roger could give you just a little color about these 2 trials. And then Chip, you can maybe talk a little bit about what you think would add to market here and manage balancing what docs will be using off-label for what any new label could be doing. So Roger, do you want to start and kind of outline this? -------------------------------------------------------------------------------- Roger D. Dansey, Seagen Inc. - Chief Medical Officer [23] -------------------------------------------------------------------------------- Sure. Sure. So Salveen, the randomized trial, EV-301 is essentially a recapitulation of cohort 1. So it's the same population patients who've seen a platinum therapy followed by a PD-1 or PD-1 inhibitor. And the important outcome is that overall survival is improved against standard chemotherapy. And that standard chemotherapy is obviously suboptimal in terms of its outcomes. I think we're really excited by that data. It is complete affirmation of the value that PADCEV can bring to this population. And obviously, physicians will react differently in terms of level of evidence. Those who believe that an overall survival signal is required before using a drug may be compelled by this, although we think we already have more than enough efficacy data to support PADCEV's use. With regard to cohort 2, this is a -- it is a different population. It is an older population, a more frail population. There is a proportion of patients, obviously, who, at the time of their initial therapy for metastatic disease are deems cisplatin ineligible. It's around about half the population are generally cisplatin eligible. And then the decision is made to use a PD-1 or a PD-1 inhibitor rather than an alternative agent like carboplatin or some of the other chemotherapies. So there is a population that clearly gets treated like that. And effectively, that PD-1, PD-L1 is a first-line treatment. And then the data that you'll see tomorrow and hopefully you'll find compelling does demonstrate that PADCEV in that situation produces excellent response rates and very durable outcomes, including overall response -- I mean duration of response outcomes. So the exact size of that population, I think, may be quite difficult to define and Chip may comment on that. Suffice to say, that checkpoint inhibitors are used widely in cancer for good reason because they make a difference. But we think that we add meaningfully to the sort of armamentarium for physicians as they manage metastatic urothelial cancer. -------------------------------------------------------------------------------- Charles R. Romp, Seagen Inc. - EVP of Commercial U.S. [24] -------------------------------------------------------------------------------- Yes. What I would add to that, Roger, thanks. I would characterize this as a smaller segment of the population, but nevertheless, a meaningful number of patients. I think it's an important unmet need. And PADCEV could offer once approved an important option for these patients. And I think that's what we're looking forward to. -------------------------------------------------------------------------------- Operator [25] -------------------------------------------------------------------------------- And our next question will come from Matthew Harrison with Morgan Stanley. -------------------------------------------------------------------------------- Matthew Kelsey Harrison, Morgan Stanley, Research Division - Executive Director [26] -------------------------------------------------------------------------------- Chip, I was wondering if you could just comment at all on what we may expect to see this year from either the arbitration or the ongoing patent specs that you have, just in terms of whether you would expect us to hear any resolution of that this year potentially? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [27] -------------------------------------------------------------------------------- Sure, thanks for the question. So there's a lot of work ongoing with our legal dispute with the DS. I will tell you that -- and I will remind you that's a better way to say it, that we are not a litigious company. More -- almost 2.5 decades, and this is the first time we've had something like this. And so this is not our goal and we want to really make a difference in the life of cancer patients. But we're compelled to defend our IP and our contracts. And so there are 2 different things going on: One is an arbitration about a contract and one is a patent infringement suit. So both of those are in play, both of those are very active. And we -- there's just a lot of legal activity on it. I'm not an attorney, so I can't describe it all to you, but -- and it's confidential. But it's not sitting still by any stretch. And so things are moving along well on that. It is -- I would -- I really hope that there is some resolution on this year. But I can't promise you that. I'm not -- I really don't know how fast arbitrators work and courts work. But we certainly would love to see this effort be completed at some point. We feel we have a fantastic case. I mean, to us, it's a straightforward case. And it's something that we think that we deserve value and -- so we'll see what happens. But thank you for the question. So -- and please stay tuned. As soon as we have something to say, you bet we will be announcing it. -------------------------------------------------------------------------------- Operator [28] -------------------------------------------------------------------------------- And our next question will come from Michael Schmidt with Guggenheim. -------------------------------------------------------------------------------- Michael Werner Schmidt, Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD [29] -------------------------------------------------------------------------------- I think I heard you mention CD40, one of your earlier-stage programs with updates here. And I think we've already seen some interesting early data at your R&D Day last year. But just curious if you could help us with expectations in terms of the data disclosures this year? And how that might inform? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [30] -------------------------------------------------------------------------------- Sure. It was hard to hear you, so I'll repeat the question for anyone who didn't hear. He asked about what we call SEA-CD40, which is a drug that sometimes I just call S40, but it is a -- it's not an antibody drug conjugate. It is an effective function enhanced antibody through our SEA technology, which basically through manufacturing very elegantly and simply, it competitively inhibits the terminal fucose from being added to an antibody, and it makes the antibody have some extraordinary properties, which can be really helpful if you're looking at depleting tumor populations. And so it's not an ADC, but it's an empowered antibody by any other way of looking at it. I've talked about it to say that I have interest in this. And so usually, I don't -- you know me for a long time. I usually don't bring up drugs that I don't really have interest in. And certainly, we've developed a number of drugs that haven't made it past early trials. And I think S40 is a very interesting drug. We have committed to presenting data on that this year. So that's where we are on it. I really -- the data will be in pancreatic cancer where we've been focused on. I am excited to complete the work. One of the things with pancreatic cancer. And if you look historically at panc, it's been a hard disease to treat. A lot of patients don't know they have the disease until they're pretty far along. It's different than some of the diseases, which have obvious symptoms that you could see until it's too late. So unfortunately, pancreatic cancer is a poorly treated disease that really needs new medicines. And so that's one of the exciting things I have because we have such a big interest in making a difference in patients' lives and have had for a couple of decades now that pancreatic cancer has always been a tough disease to treat. So we're excited to see if we can make a difference in these patients' lives. The early data is very interesting. And we -- I mentioned it at one or 2 calls that I was interested in. But if you look historically, there's a lot of times in pancreatic cancer, where you see some early data and hence -- and then folks do larger studies, and it doesn't pan out. And so that's something that if you don't learn the lessons of history, you're going to repeat them again. So we certainly have learned that. We've watched it. And so we took some very exciting -- interesting, exciting, early data, and we've expanded it pretty dramatically to try to gain really good handle on what responses are, what's the duration, maybe even an early way of looking at does this impact survival. So to see as best as we can, what the data means. And then when we report the data, we also are -- as we look at the data and report the data, the question really is, what happens next? And I'm hopeful that when the data come out, the data is robust and it's exciting, and we decide to go into a pivotal trial. And I don't know yet. We're not announcing that. We're not guiding. But your question was, what should we look for? Roger, do you have any other thing you want to mention about what they should look for? -------------------------------------------------------------------------------- Roger D. Dansey, Seagen Inc. - Chief Medical Officer [31] -------------------------------------------------------------------------------- I think that just to sort of repeat, the scientific hypothesis we're testing is a strong one. There's good preclinical data. The combination of a CD40 agonist, which we have had in the clinic, we already have evidence of single-agent activity in some other diseases. But in this construct, we are combining it together with the frontline chemotherapy, which is ABRAXANE sort of gemcitabine-based chemotherapy together with a PD-1 inhibitor. And those 3 interventions, those are all sort of kill the cancer cell with the chemotherapy, stimulate antigen presentation with the CD40 and other things, by the way, from a mechanistic perspective, and then make sure that the breaks are taken off any of the T cells. So it's a very strong scientific hypothesis. As Clay said, we've enrolled a good number of patients. We will wait for the data to read out. And we'll make out a determination at that point as to what our next steps could be. -------------------------------------------------------------------------------- Operator [32] -------------------------------------------------------------------------------- And our next question will come from Gena Wang with Barclays. -------------------------------------------------------------------------------- Xiaozhou Fan, Barclays Bank PLC, Research Division - Research Analyst [33] -------------------------------------------------------------------------------- This is Sheldon Fan on behalf of Gena. Just 2 very quick one on the guidance, one is on PADCEV. In your prepared remarks, you mentioned that considering PADCEV's current high -- their high market share, could you comment on what range of market share are we talking about, like 40% to 60% or 80% or even higher? And another one is on the TUKYSA's guidance. What type of OUS revenue are you assuming in this guidance? Or are we talking about predominantly U.S. sales for 2021? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [34] -------------------------------------------------------------------------------- Yes. So thank you for the question. On the specifics of market share percentage, that's not something we usually talk about because once you start going into percentage then every quarter, everyone's asking what's your percentage and all that. And just -- it's kind of -- we report our numbers, and that's really what's important. And so we feel it's standard of care. And Chip, if he wants to, can make a comment on the market share and what doctors think of this, and -- with PADCEV. On TUKYSA with the guidance, I think I'd like Todd to make a comment on, you asked a question about outside U.S. revenue and what's included in guidance. So why don't we start there with Todd. Todd, why don't you start on the guidance for TUKYSA. -------------------------------------------------------------------------------- Todd E. Simpson, Seagen Inc. - CFO [35] -------------------------------------------------------------------------------- Sure, Gena. Thanks for the question. So the vast majority of our TUKYSA guidance is U.S. sales. And we do have approvals in a few other countries under project Orbis. And of course, we're looking forward to approvals broadly in Europe and starting to do that next year. But the vast majority of our guidance for TUKYSA is U.S.-based. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [36] -------------------------------------------------------------------------------- Okay. And then on -- going back to PADCEV on the market share and stuff like that. Chip, do you want to give a little color on that? -------------------------------------------------------------------------------- Charles R. Romp, Seagen Inc. - EVP of Commercial U.S. [37] -------------------------------------------------------------------------------- Yes. Thanks, Clay. So as a standard of care, I would say that we're well positioned in 2021 to intersect at a very important point in these changing market dynamics. I think you're going to continue to see the PD-1 and PD-L1 utilization increase in frontline. And I think that's going to put PADCEV in a favorable position. -------------------------------------------------------------------------------- Operator [38] -------------------------------------------------------------------------------- And our next question will come from Andy Hsieh with Blair. -------------------------------------------------------------------------------- Tsan-Yu Hsieh, William Blair & Company L.L.C., Research Division - Senior Research Analyst [39] -------------------------------------------------------------------------------- Congratulation to everyone at Seagen for a banner year in 2020. So I had a question in kind of early-stage bladder cancer for PADCEV. It seems like you guys basically encroach to hold bladder cancer treatment paradigm everywhere overnight. So specifically in the nonmuscle-invasive bladder cancer, there's been some challenges associated with BCG supply. Just wondering for the intravesical use, are you looking at -- beyond the nonresponsive, are you looking at patients who are not suitable for BCG as well, just to kind of broaden the opportunity be there? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [40] -------------------------------------------------------------------------------- Yes. Thank you for the question. We're really excited about PADCEV in all aspects of bladder cancer, like you say, whether it's metastatic, muscle-invasive where we have a lot going on, as Roger talked about. And our next area that we're going after is non-muscle basis. And we've done a lot of work on there. We haven't started the trials yet. We're well aware of the BCG challenges. Roger, do you want to give a little color on the intravascular use and what we're thinking? -------------------------------------------------------------------------------- Roger D. Dansey, Seagen Inc. - Chief Medical Officer [41] -------------------------------------------------------------------------------- Yes. So Andy, it's a great question. Obviously, we're just beginning, and we haven't disclosed any of the clinical trial plans, but we are -- as we said in prepared remarks, we are in advanced planning. We think the profile for PADCEV could be very favorable based on minimal systemic exposure and activity directly into the bladder. The place to start, as you say, for all programs is in BCG nonresponsive. But if we find PADCEV is active in that population, we would obviously move or make plans to move into earlier lines of therapy. Again, it's a balance of how much benefit can we bring versus how much risk do we bring to bear on the circumstance. And until we've generated the data we won't know. But I can tell you aspirationally, we would like to have PADCEV positioned if we can in non-muscle invasive bladder cancer wherever it's appropriate to address the unmet need. -------------------------------------------------------------------------------- Operator [42] -------------------------------------------------------------------------------- And our next question will come from Andrew Berens with SVB Leerink. -------------------------------------------------------------------------------- Andrew Scott Berens, SVB Leerink LLC, Research Division - MD of Targeted Oncology & Senior Research Analyst [43] -------------------------------------------------------------------------------- I was wondering if there's a potential for increased rates or increased severity of skin rash when you have PADCEV with checkpoints versus PADCEV alone? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [44] -------------------------------------------------------------------------------- Thank you very much for the question on that. We're in trials now, as you know. Roger, can you comment as to -- we have some data that's actually been presented on this. But we have ongoing trials. And so perhaps talking about anything we've seen in the -- and the data that is going to be fair game. Roger? -------------------------------------------------------------------------------- Roger D. Dansey, Seagen Inc. - Chief Medical Officer [45] -------------------------------------------------------------------------------- Sure. So Andy, as you know, we believe we're confident in, and we believe that the combination of PADCEV plus KEYTRUDA has tremendous potential in bladder cancer, not just in metastatic, but in the muscle-invasive circumstance as well. And there is lots of scientific reasons to believe that a vedotin based ADC may be particularly powerful when it's combined with PD-1 inhibitor. From a safety perspective, obviously, all clinical trials that we run, we monitor safety carefully. There are no changes to any of our plans with regards to what we are doing in our clinical trials. The data we presented to date, which is around 45 subjects, where we did report overall skin rashes and grade 3 rashes in... -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [46] -------------------------------------------------------------------------------- Roger, I just lost hearing you. Can you guys hear me? -------------------------------------------------------------------------------- Charles R. Romp, Seagen Inc. - EVP of Commercial U.S. [47] -------------------------------------------------------------------------------- Yes. I think it's related to Roger. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [48] -------------------------------------------------------------------------------- Yes. Okay. Well, we lost Roger. So Andy, are you still on? -------------------------------------------------------------------------------- Andrew Scott Berens, SVB Leerink LLC, Research Division - MD of Targeted Oncology & Senior Research Analyst [49] -------------------------------------------------------------------------------- Yes. I'm still here. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [50] -------------------------------------------------------------------------------- Okay. Did you get enough of an answer from Roger? -------------------------------------------------------------------------------- Andrew Scott Berens, SVB Leerink LLC, Research Division - MD of Targeted Oncology & Senior Research Analyst [51] -------------------------------------------------------------------------------- I think he was just about to talk about the data in the 45 patients. So cut off, unfortunately. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [52] -------------------------------------------------------------------------------- Yes. Yes. So Roger got cut off. Our data in the patients did not show anything that was obvious to us that there'd be a problem at all. In fact, it shows the opposite. It showed that the patients did incredibly well on the 2 drugs together. And we got breakthrough designation, and we've been enrolling a lot of patients in both the accelerated trial and the global trial. And so where we sit now, we're pretty darn excited on this. And I don't know any reason that we would be inhibited from going forward if that's what you're looking for. -------------------------------------------------------------------------------- Andrew Scott Berens, SVB Leerink LLC, Research Division - MD of Targeted Oncology & Senior Research Analyst [53] -------------------------------------------------------------------------------- No, I was more interested in just if the rash is worse or more frequent, and it could be more of a commercial issue? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [54] -------------------------------------------------------------------------------- Yes. We have not seen that. In the trial that we presented on, we have not seen that. We don't see any potential limitation in commercial with a combination at this point. Obviously, that's why you do big studies and you study these. So we'll have to see in the future. But for what we've seen to date, we see no issue with going forward commercial that we've taken up PADCEV very well. I mean it's really -- I mean, it's really exciting to see a drug become standard of care in metastatic setting pretty quickly. -------------------------------------------------------------------------------- Peggy Pinkston, Seagen Inc. - VP of IR [55] -------------------------------------------------------------------------------- Okay. Operator, we have time for one more question. -------------------------------------------------------------------------------- Operator [56] -------------------------------------------------------------------------------- Absolutely. And that question will come from Jay Olson with Oppenheimer. -------------------------------------------------------------------------------- Jay Olson, Oppenheimer & Co. Inc., Research Division - Executive Director & Senior Analyst [57] -------------------------------------------------------------------------------- Congrats on all the progress. I appreciate your 3 pillared strategy. And wanted to ask you about your plans to maximize the global potential of your portfolio, which you've traditionally done through partnerships outside the U.S. And now since you're building a TUKYSA team in Europe. Do you envision eventually building a global infrastructure and taking your early-stage pipeline all the way from development through global registration and commercialization independently? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [58] -------------------------------------------------------------------------------- So Jay, first of all, thank you for the question. Thank you for noting that we have expanded on the back of TUKYSA to include greater Europe, which is quite a lot of countries. So -- and our team there is just ready to go. We're really excited to start getting this out to patients in need and working with docs and all that. So I'm hopefully we got soon. But as far as the future path there, what I would say is, it depends. And I don't mean to be ignoring your question. It is not that easy for U.S. biotech or for that matter, U.S. pharma sometimes, to do a lot of work in, let's say, certain parts of Asia, especially the 2 biggest markets, Japan and China. And so it is something that we're looking at closely as to what we would do with additional drugs and whether we would consider putting in Asia, for instance, at some of the big markets. And so that's something we're talking about. I don't want to tell you, yes, we're going to do it or no. We do have great partners. We know all the best partners and distributors in different territories and whether we want a partnership or distribution is something we have to look at everywhere. But I'm really glad that we're going broader in a commercial way, and I hope as part of our pillars that we continue to broaden out our global reach. -------------------------------------------------------------------------------- Operator [59] -------------------------------------------------------------------------------- And this concludes the question-and-answer session. I'd like to turn the conference back over to management for any closing remarks. -------------------------------------------------------------------------------- Peggy Pinkston, Seagen Inc. - VP of IR [60] -------------------------------------------------------------------------------- Okay. Thank you, operator, and thanks, everybody, for joining us this afternoon. We look forward to staying in touch, and hope you have a good evening. -------------------------------------------------------------------------------- Operator [61] -------------------------------------------------------------------------------- The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines at this time.