U.S. markets close in 1 hour 24 minutes
  • S&P 500

    3,833.20
    -37.09 (-0.96%)
     
  • Dow 30

    31,378.06
    -13.46 (-0.04%)
     
  • Nasdaq

    13,026.29
    -332.50 (-2.49%)
     
  • Russell 2000

    2,221.33
    -10.18 (-0.46%)
     
  • Crude Oil

    61.23
    +1.48 (+2.48%)
     
  • Gold

    1,712.50
    -21.10 (-1.22%)
     
  • Silver

    26.25
    -0.63 (-2.36%)
     
  • EUR/USD

    1.2070
    -0.0018 (-0.14%)
     
  • 10-Yr Bond

    1.4690
    +0.0540 (+3.82%)
     
  • GBP/USD

    1.3956
    -0.0001 (-0.01%)
     
  • USD/JPY

    106.9880
    +0.2780 (+0.26%)
     
  • BTC-USD

    50,468.93
    +2,587.34 (+5.40%)
     
  • CMC Crypto 200

    1,010.84
    +22.75 (+2.30%)
     
  • FTSE 100

    6,675.47
    +61.72 (+0.93%)
     
  • Nikkei 225

    29,559.10
    +150.93 (+0.51%)
     

Edited Transcript of SGEN.OQ earnings conference call or presentation 30-Apr-20 8:30pm GMT

·55 min read
  • Oops!
    Something went wrong.
    Please try again later.

Q1 2020 Seattle Genetics Inc Earnings Call Bothell Oct 13, 2020 (Thomson StreetEvents) -- Edited Transcript of Seagen Inc earnings conference call or presentation Thursday, April 30, 2020 at 8:30:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Charles R. Romp Seagen Inc. - EVP of Commercial * Clay B. Siegall Seagen Inc. - Co-Founder, Chairman, President & CEO * Peggy Pinkston Seagen Inc. - VP of IR & Executive Director of Corporate Communications * 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 * Chad Jason Messer Needham & Company, LLC, Research Division - Senior Analyst * Connor McGuinness Meehan Morgan Stanley, Research Division - Research Associate * George Farmer BMO Capital Markets Equity Research - Analyst * Gregory Allen Harrison BofA Merrill Lynch, Research Division - Research Analyst * Huidong Wang Barclays Bank PLC, Research Division - Research Analyst * Joseph Michael Catanzaro Piper Sandler & Co., Research Division - VP & Senior Biotech Analyst * Kennen B. MacKay RBC Capital Markets, Research Division - MD & Co-Head of US Biotechnology Research * Michael Werner Schmidt Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD * Salveen Jaswal Richter Goldman Sachs Group, Inc., Research Division - VP * Silvan Tuerkcan * Stephen Douglas Willey Stifel, Nicolaus & Company, Incorporated, Research Division - Director * Tsan-Yu Hsieh William Blair & Company L.L.C., Research Division - Senior Research Analyst * Turner Andrew Kufe JPMorgan Chase & Co, Research Division - Research Analyst ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Good day, and welcome to the Seattle Genetics First Quarter 2020 Financial Results Conference Call. Today's call is being recorded. At this time, I would 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 & Executive Director of Corporate Communications [2] -------------------------------------------------------------------------------- Thank you, operator, and good afternoon, everyone. I'd like to welcome all of you to Seattle Genetics' First Quarter 2020 Conference Call. With me today are Clay Siegall, President and Chief Executive Officer; Chip Romp, Executive Vice President, Commercial; Todd Simpson, Chief Financial Officer; and Roger Dansey, Chief Medical Officer. Accompanying today's conference call are supporting slides which are available on our website in the Investors section, Events and Presentations page. Following our prepared remarks, we'll open the line for questions. (Operator Instructions) Today's conference call will include forward-looking statements regarding future or anticipated events and results, including the company's 2020 financial outlook, anticipated product sales, revenues, costs and expenses and timing to achieve 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 Seattle Genetics is contained under the caption Risk Factors included in the company's periodic reports filed with the Securities and Exchange Commission, including the company's annual report on Form 10-K for the year ended December 31, 2019. 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. Seattle Genetics has made remarkable progress over the past few months. I've been extremely proud of our accomplishments and the focus and creativity of our team during a period of significant global and individual impact. We broadened our commercial portfolio, which now includes 3 first-in-class or best-in-class medicines for cancer patients. ADCETRIS is an important global brand for lymphoma, and we are investing in future growth opportunities. PADCEV was approved in late December for metastatic urothelial cancer. And today, we are pleased to announce a strong first full quarter of sales. And earlier this month, we received approval of TUKYSA for metastatic breast cancer 4 months ahead of the PDUFA date. These are significant milestones, and we remain excited with the expansion opportunities across these 3 programs as well as our emerging earlier-stage pipeline. I'll begin today with some comments on each of our approved programs, starting with ADCETRIS. We're pleased to report ADCETRIS net sales of $164 million in the first quarter of 2020, up 22% over the first quarter of 2019. We are maintaining our guidance of full year 2020 ADCETRIS net sales in the range of $675 million to $700 million. Our ADCETRIS partner, Takeda, continues to make global regulatory progress. Most recently, CHMP adopted a positive opinion, recommending extension of the marketing authorization for ADCETRIS plus chemotherapy for frontline systemic anaplastic large cell lymphoma based on results from the ECHELON-2 trial. We look forward to additional frontline Hodgkin and PTCL approvals in Takeda's territory over time. We believe there are several additional opportunities for ADCETRIS and are advancing ongoing and planned clinical trials in a range of settings. These include retreatment use in patients who are unfit for combination chemotherapy, novel frontline Hodgkin lymphoma combinations and relapsed/refractory diffused large B-cell lymphoma. We also expect to report 5-year progression-free survival results later this year from both the ECHELON-1 and ECHELON-2 trials. These data could further establish the positive long-term benefit of the approved ADCETRIS plus chemotherapy regimen in frontline Stage III and IV Hodgkin lymphoma and in frontline CD30-expressing PTCL. I'll move on now to PADCEV, which we're developing and commercialization in collaboration with Astellas. PADCEV was approved in late December 2019, 3 months ahead of the PDUFA date. In its first full quarter on the market, PADCEV net sales in the U.S. were $34 million. We're pleased by the initial physician and patient reception to PADCEV as well as our commercial team's ability to shift mid-quarter to a virtual engagement. There are additional opportunities for PADCEV in earlier lines end stages of bladder cancer. A primary focus of this work is evaluating PADCEV in combination with KEYTRUDA. In the past months, we've made important progress with both first-line metastatic urothelial cancer and muscle-invasive bladder cancer that Roger will describe in more detail. Looking beyond bladder cancer, the first patient was recently dosed in the EV-202 basket trial, evaluating single-agent PADCEV in a range of solid tumors. Our third and newest commercial product is TUKYSA, the brand name for tucatinib. We're very pleased with the strong label granted by FDA. TUKYSA is approved for use in combination with trastuzumab and capecitabine for patients with metastatic HER2-positive breast cancer, including patients with brain metastasis who have received one or more prior anti-HER2-based regimens in the metastatic setting. This positions the regimen as an option for second-line treatment. We're almost 2 weeks into the launch of TUKYSA, which we're conducting through virtual communication channels. We've been pleased by the reception from the breast cancer community to this new treatment option for patients. To maximize the potential of TUKYSA, we're investing in a broad development program across HER2-positive cancers. In addition, we're preparing for European commercial operations and have hired general managers in major European markets ahead of potential ex U.S. approvals of TUKYSA. Turning now to our pipeline. On the horizon with a clinical trial readout is tisotumab vedotin, or TV, which we are developing in collaboration with Genmab. We're conducting a pivotal Phase II single-arm, single-agent trial in women with recurrent or metastatic cervical cancer where there is no standard of care and outcomes are poor. We expect to report top line results late this quarter or into the third quarter. Our early-stage clinical pipeline is robust. It includes ADCs such as ladiratuzumab vedotin, SGN-CD228 and SGN-B6A, for which an IND has just been submitted. These 3 ADCs are all targeted to receptors that are widely expressed in solid tumors. To expand upon our deep knowledge of CD30-expressing malignancies and our expertise with CD30-directed ADCs, we're advancing another IND candidate this year called, SGN-CD30C. This is a novel anti-CD30 ADC that has the potential for enhanced activity and improved tolerability compared to ADCETRIS. Preclinical data on SGN-CD30C will be presented along with several other abstracts on our research at the AACR virtual annual meeting in June. In addition to ADCs, we've made progress with novel immunotherapy agents in our early-stage clinical pipeline. These include SEA-CD40 and SGN-TGT. Lastly, I wanted to provide an update on our dispute with Daiichi Sankyo regarding ownership of certain technology used in the breast cancer drug and HER2 and other product candidates. According to our agreement, this type of dispute should be resolved through arbitration. Daiichi Sankyo has been trying to prevent our dispute from going to arbitration through actions in federal court. On April 27, it was ruled that the dispute should be resolved in arbitration and that the arbitration process should move forward. We view this as a positive development. With our diverse commercial portfolio, growing revenues and multiple programs that provide significant opportunities in a range of cancer types, we are well positioned for the future. At this point, I'll turn the call over to Chip to discuss our commercial activities. Then Todd will comment on our financial results. After that, Roger will discuss our clinical development activities. Chip? -------------------------------------------------------------------------------- Charles R. Romp, Seagen Inc. - EVP of Commercial [4] -------------------------------------------------------------------------------- Thanks, Clay. I'm excited to update you on our commercial activities. ADCETRIS net sales growth in the U.S. and Canada in the first quarter was driven by our frontline indications in Hodgkin lymphoma and PTCL. As Clay mentioned, we look forward to the 5-year PFS data later this year from the ECHELON-1 trial. 5-year data are an established standard that we believe will resonate with some physicians who've been slow to adopt ADCETRIS plus AVD in the frontline setting. In PTCL, ADCETRIS has become the standard of care for patients with ALCL. One of our areas for focus in 2020 is to increase use in additional CD30-expressing subtypes. Now I'd like to transition to PADCEV. In the first full quarter since launch, net sales were $34 million. We are very pleased with these early results and with the strong uptake, particularly in the community setting. We are still early into the launch, and our goal with PADCEV is to maintain our strong momentum. Along with our Astellas colleagues, we are working hard to support our customers and to drive awareness and understanding of this important new treatment option for metastatic urothelial patients, seeking treatment after platinum and PD-1 or PD-L1 therapy. And finally, our third product is TUKYSA. The commercial team was ready for the rapid approval; marketing materials were complete; physician and patient websites were up the day of approval; and the dedicated TUKYSA sales force, comprised of breast cancer specialists, was trained and ready. Interest in the product is very high, and our field sales teams are reporting good virtual access to customers. TUKYSA is available in our distribution networks, and accounts are beginning to order. I look forward to updating you on our progress in future calls. Now I'll turn the call over to Todd. -------------------------------------------------------------------------------- Todd E. Simpson, Seagen Inc. - CFO [5] -------------------------------------------------------------------------------- Thanks, Chip, and thanks to everyone for joining us on the call this afternoon. Our financial results for the first quarter reflect significant progress across the business, including a strong first quarter of PADCEV sales. Today, I'll summarize our results for the first quarter and then comment on our outlook for the remainder of 2020. Total revenues were $235 million in the first quarter of 2020. This included ADCETRIS net sales of $164 million and PADCEV net sales of $34 million. As a reminder, we record 100% of PADCEV sales in the U.S. under our co-promote with Astellas. Royalty revenues in the first quarter of 2020 increased to $20 million compared to $16 million in the first quarter 2019. This growth primarily reflects sales of ADCETRIS by Takeda and, to a lesser degree, now royalties on sales of Polivy by Roche. Collaboration revenues were $16 million in the first quarter of 2020 compared to $45 million in the first quarter of last year. The decrease in collaboration revenues is the result of a $30 million milestone from Takeda earned last year that was triggered by the approval of ADCETRIS in the EU for frontline Hodgkin lymphoma. Cost of sales for the first quarter of 2020 increased to $29 million and now reflects both ADCETRIS and PADCEV, including the PADCEV profit share to Astellas that was $16 million in the first quarter. Beginning in the second quarter, cost of sales will also reflect TUKYSA and will also include the noncash amortization of acquired in-process R&D that was part of the Cascadian acquisition. We plan to provide further guidance on cost of sales on future calls. R&D expenses were $195 million in the first quarter of 2020, and growth over 2019 reflects higher investment across our pipeline. SG&A expenses were $122 million in the first quarter of 2020. The increase over 2019 reflects commercialization efforts related to the launches of PADCEV and TUKYSA. We ended the first quarter with $800 million in cash and investments. In addition, we held approximately $104 million in Immunomedics common stock at the end of the quarter. These shares are mark-to-market, which resulted in a noncash loss that contributed to an overall investment loss of $56 million for the first quarter. We monetized the remaining portion of our investment in April, which generated cash of $175 million. We acquired this investment back in 2017, and our total gain, when also including prior year sales, was $210 million. Regarding our financial outlook for 2020, product sales will now include all 3 brands. At this point, we're not providing guidance for PADCEV or TUKYSA, and our ADCETRIS guidance is unchanged from our expectations provided in February. We expect R&D expenses to increase as trials of PADCEV and TUKYSA ramp up. SG&A expense growth in 2020 is primarily driven by the U.S. launches of both PADCEV and TUKYSA. Our guidance for R&D and SG&A expenses remains unchanged. Lastly, we continue to closely monitor the impact of COVID-19 on our business. We have implemented a number of measures to protect the health and safety of our employees, patients and health care professionals while also taking steps to advance our operations. These include efforts to mitigate disruptions to our supply chain and continue clinical trial and commercial activities. To date, we're pleased with the continuity of our business and in our ability to support the critical need of cancer patients for treatment. However, COVID-19 has created a dynamic environment that may impact the company over time. We will keep investors updated as appropriate going forward. And with that, I'll now turn the call over to Roger. -------------------------------------------------------------------------------- Roger D. Dansey, Seagen Inc. - Chief Medical Officer [6] -------------------------------------------------------------------------------- Thanks, Todd, and good afternoon, everyone. I'm pleased to update you today on our clinical development and regulatory activities and the work we're undertaking to maximize the therapeutic potential of our programs. I'll start with PADCEV, our ADC directed against Nectin-4, which is ubiquitously expressed in bladder cancer. As you know, data from the first cohort of the EV-201 trial supported approval of PADCEV in metastatic urothelial cancer patients following treatment with a platinum-containing regimen and a PD-1 or PD-L1 inhibitor. Earlier this month, we completed enrollment in the second cohort, which is evaluating patients who received the PD-1 or PD-L1 inhibitor but who were not eligible for treatment with cisplatin. We believe data from the second cohort of EV-201 could potentially support a second indication for PADCEV. Our other key activity with PADCEV monotherapy is the ongoing randomized Phase III EV-301 trial in advanced urothelial cancer. Enrollment of 608 patients was completed early this year, and we are following patients for the primary end point of overall survival. EV-301 is intended to serve as a confirmatory study for EV-201 and support global regulatory applications for approval. PADCEV in combination with KEYTRUDA in first-line metastatic urothelial cancer is another key effort. At the ASCO GU meeting in February, we reported updated results from the EV-103 trial of 45 metastatic urothelial cancer patients who were previously untreated and ineligible for certain cisplatin-based chemotherapy. The objective response rate was 73% and median duration response had not been reached. Median progression-free survival was 12 months, and median overall survival was not reached. The safety profile appeared consistent with individual components of the combination including rash, hyperglycemia, peripheral neuropathy and immune-mediated events. These data supported breakthrough therapy designation from the FDA for PADCEV in combination with KEYTRUDA in this setting. This is our second PADCEV BTD. Based on discussion with the FDA, we are pleased that EV-103 now has the potential to support an accelerated approval for PADCEV in first-line cisplatin-ineligible metastatic disease. In January, we added cohort K to the trial, which will enroll 150 patients randomized to receive either PADCEV plus KEYTRUDA or PADCEV alone. The primary end point is objective response rate supported by duration of response. This accelerated pathway would be complementary to the randomized Phase III EV-302 trial that is intended to support global registrations and now also serves as a potential confirmatory trial. Today, we are announcing that we have treated the first patient in EV-302. In this trial, together with Astellas and Merck, we are evaluating the PADCEV and KEYTRUDA combination with or without chemotherapy compared to chemotherapy alone. Target enrollment is 1,095 patients and, importantly, includes all patients, whether they are cisplatin-eligible or ineligible and irrespective of PD-L1 expression. The trial is evaluating dual primary end points of progression-free and overall survival. In early bladder cancer, Seattle Genetics, Astellas and Merck recently completed a clinical trial agreement under which we will evaluate PADCEV and KEYTRUDA in muscle-invasive bladder cancer by adding an arm to an ongoing Merck Phase III registrational trial. Under this agreement, we are providing PADCEV, and Merck will continue to fund and operationalize the study. This expedites the development of the PADCEV-KEYTRUDA combination in this setting. I'll now move on to TUKYSA, our recently approved oral tyrosine kinase inhibitor that targets HER2. We are very pleased by the FDA label and the speed at which we received approval under the FDA's Real-Time Oncology Review. We believe that the activity seen in the HER2CLIMB trial establishes TUKYSA as a best-in-class HER2 TKI. At the ASCO virtual scientific program in late May, we will present analyses on patients with brain metastases in HER2CLIMB to further demonstrate the treatment effects of TUKYSA observed in the brain. The data which was selected for an oral presentation will provide more insight into this aspect of the trial. Our ongoing regulatory efforts with HER2CLIMB include marketing applications that are currently under review in Switzerland, Singapore, Australia and Canada as part of Project Orbis and also in the EU. We are also evaluating TUKYSA in a randomized Phase III trial, called HER2CLIMB-02, in combination with T-DM1 versus T-DM1 alone in metastatic breast cancer, including patients with brain metastases. In this trial, patients must have previously received a taxane and trastuzumab in the neoadjuvant, adjuvant or metastatic setting and thus represent a population receiving first- or second-line treatment. HER2CLIMB-02 remains a key part of our TUKYSA development program. Both TUKYSA and T-DM1 are important drugs for the treatment of HER2-positive breast cancer. And if HER2CLIMB-02 is successful, it will support the use of the combination in the first-line metastatic setting, thus expanding beyond the current label. In addition, given the demonstrated activity of TUKYSA in patients with brain met, the combination may also improve outcomes for these patients. Enrollment in HER2CLIMB-02 is ongoing with a target of 460 patients. The primary end point is progression-free survival, and key secondary end points are overall survival and PFS in patients with brain met. Lastly, on TUKYSA, we previously outlined our plans in neoadjuvant breast cancer and metastatic colorectal cancer, and those efforts are continuing. Trials in adjuvant breast cancer, gastric cancer and HER2-mutant or amplified cancers are in the planning phase. Next, I'll turn to ADCETRIS. We recently expanded our clinical collaboration with Bristol-Myers Squibb to further evaluate the combination of ADCETRIS and Opdivo in an ongoing clinical trial. The focus of this new effort will be to assess the combination plus chemotherapy in Stage 1 and 2 Hodgkin lymphoma. This approach brings together 2 of the most active agents in early-stage Hodgkin lymphoma. Our goal is to improve efficacy while reducing toxicity by limiting the chemotherapy components of the regimen. Now I'll turn the call back over to Clay. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [7] -------------------------------------------------------------------------------- Thanks, Roger. Before we open the line for questions, I want to recap key upcoming activities across our oncology portfolio. They include: first, continue to establish ADCETRIS as standard of care in frontline Hodgkin lymphoma and frontline PTCL and initiate additional clinical trials; second, continue our strong PADCEV launch in the U.S. with Astellas and advance broad development program, including trials in first-line metastatic and muscle-invasive bladder cancer; third, continue to launch TUKYSA following the recent FDA approval and advance its robust clinical development program; and fourth, report top line results from the TV pivotal trial in cervical cancer. We look forward to continuing our momentum into the remainder of the year. At this point, we'll open the line for Q&A. Operator, please open the call for questions. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) And we will take our first question from Salveen Richter with Goldman Sachs. -------------------------------------------------------------------------------- Salveen Jaswal Richter, Goldman Sachs Group, Inc., Research Division - VP [2] -------------------------------------------------------------------------------- And congratulations on the PADCEV launch. What has been the key drivers for the rapid uptake here for PADCEV? And how should we think about the launch trajectory on the Board? And maybe you can just comment on that part as to whether there was a bolus of patients in 1Q. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [3] -------------------------------------------------------------------------------- Yes. Salveen, thank you very much for the question. We're delighted with our first full quarter of PADCEV sales at $34 million. And as I previously had mentioned on other calls that along the way, that was exceeding our expectations early on. We mentioned that the uptake was good, including in the community setting. But at this point, it's really -- it's hard to really look and see whether sites -- and we can't really see that sites are accumulating inventory or that there was pent-up demand or things like that. So it's very hard to see that right now. This is an important drug for a disease that didn't really have a lot of good therapy. And so I think we're there and helping patients in a big way. Chip, do you want to add anything to PADCEV that I didn't mention? -------------------------------------------------------------------------------- Charles R. Romp, Seagen Inc. - EVP of Commercial [4] -------------------------------------------------------------------------------- Sure, Clay. Yes. We generally don't see sites include significant inventory or accumulate significant inventory. This is kind of a just-in-time delivery model. So generally when they're ordering, they have a patient. I think you're right in saying that this just represents an advancement, I think, for bladder cancer and that this wasn't a good treatment alternatives out in the marketplace. -------------------------------------------------------------------------------- Operator [5] -------------------------------------------------------------------------------- We'll take our next question from Kennen MacKay with RBC Capital Markets. -------------------------------------------------------------------------------- Kennen B. MacKay, RBC Capital Markets, Research Division - MD & Co-Head of US Biotechnology Research [6] -------------------------------------------------------------------------------- Let me offer my congrats on the really incredible PADCEV launch as well, even a very bullish estimate despite a global pandemic ongoing, so huge, huge congrats there. So PADCEV has been discussed a little bit. So I was going to ask elsewhere. I was wondering what you're seeing around the impact of ADCETRIS use due to the COVID pandemic. It seems like it might have been a little bit impacted in Q1 or maybe in March. And then also it seems like the tisotumab vedotin readout maybe got pushed back a little bit. Given this trial was fully enrolled, I'm wondering if we should be thinking that maybe that's suggesting a longer progression-free survival responses of ongoing scan collection from some of these patients that are in that trial. Congrats again. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [7] -------------------------------------------------------------------------------- Thank you. So with ADCETRIS, we're really excited about ADCETRIS. It's a great drug. It's helped tens of thousands of patients and continues to. The first time that this drug ever hit $1 billion in sales globally was last year. Sales have doubled over the past 2 years. And quarter-on-quarter from 2019, it was 22% up. And the first quarter is always a little bit light with ADCETRIS, and it has been year in and year out, so I look at the quarter over [this year's] first quarter. Now having said that, you did bring up COVID-19. And certainly, that is a -- it's something to look at. Whether there's a small number of patients that are unable to come in and get therapy for lymphoma is something that very well could be happening. It's really hard to know exactly. But we're really excited about our 5-year data coming out later this year. And it's something that we haven't changed our guidance for the year. So I think that that's really something important to look at. Now you briefly snuck in a second question on TV about timing. The most important thing with our data with TV is that this is potentially registerable. And we need to follow the data and follow the duration of the data and work with a third party that puts these type of blinded data together and -- before we can present this and reveal the data. So that's something that's ongoing. We're working hard at. They may very well come this quarter, okay? And we're working toward trying to make that happen. We just put out that it may slip a little bit into the third quarter, just in case it does, but we're working hard to get this done in the soonest timeframe possible. So I wouldn't read too much into it. And you'll hear about it soon. -------------------------------------------------------------------------------- Operator [8] -------------------------------------------------------------------------------- We'll take our next question from Cory Kasimov with JPMorgan. -------------------------------------------------------------------------------- Turner Andrew Kufe, JPMorgan Chase & Co, Research Division - Research Analyst [9] -------------------------------------------------------------------------------- This is Turner on for Cory. On TUKYSA, we've heard from a few docs that pharmacy copays could be a barrier to access for some patients just based on experience from other orally administered products. What are your thoughts on this? And can you comment on some of the programs you're undertaking right now on this front? And then also on EV, I'm curious when we could expect data from the EV-103 study for patients that are platinum-eligible. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [10] -------------------------------------------------------------------------------- Okay. You asked a question on the EV-103 trial. It was a little hard for me to hear it. Roger, did you capture the question? -------------------------------------------------------------------------------- Roger D. Dansey, Seagen Inc. - Chief Medical Officer [11] -------------------------------------------------------------------------------- Yes, I did. I did. And thanks for the question. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [12] -------------------------------------------------------------------------------- Can you do that first? And then we'll go back to the TUKYSA question with Chip. -------------------------------------------------------------------------------- Roger D. Dansey, Seagen Inc. - Chief Medical Officer [13] -------------------------------------------------------------------------------- Sure. Sure. I can do that. So the question was when would we expect data from the 103 trial that would lead to a potential approval in cisplatin-eligible frontline metastatic bladder cancer. And the answer is we started the cohort in January, the total number enrolled is 150. It's a randomization versus PADCEV monotherapy to PADCEV plus KEYTRUDA. The enrollment is going as we expect. We are not -- we can't reveal the timing of that. But just to point out, the response rate and duration of response are the 2 end points that we need. So we understand once we're fully enrolled what that timing will look like, but we just can't reveal that at this point. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [14] -------------------------------------------------------------------------------- Okay. And Chip, can you comment on what Turner had heard about TUKYSA and copay and any potential barrier. We work very hard to make that not happen. So Chip, can you talk about our systems for doing that? -------------------------------------------------------------------------------- Charles R. Romp, Seagen Inc. - EVP of Commercial [15] -------------------------------------------------------------------------------- Sure, Clay. Through our already established SeaGen Secure program, we will provide copay assistance for eligible commercially insured patients to help with -- in order to minimize out-of-pocket costs associated with the product. -------------------------------------------------------------------------------- Operator [16] -------------------------------------------------------------------------------- We'll take our next question from Matthew Harrison with Morgan Stanley. -------------------------------------------------------------------------------- Connor McGuinness Meehan, Morgan Stanley, Research Division - Research Associate [17] -------------------------------------------------------------------------------- This is Connor Meehan on for Matthew. So just on PADCEV, can you elaborate a bit on your discussions with the FDA and the accelerated approval in the frontline and I guess how those conversations have been going and how they may impact the timeline there? And then just quickly on COVID and on the launch, what sort of penetration have you guys been seeing thus far? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [18] -------------------------------------------------------------------------------- Matthew (sic) [Connor], I am so sorry to ask you, and I apologize for this multimedia way of doing this. Can you -- my phone cut out just for a second. Can you go through your 2 questions one more time briefly? -------------------------------------------------------------------------------- Connor McGuinness Meehan, Morgan Stanley, Research Division - Research Associate [19] -------------------------------------------------------------------------------- Sure. Yes, yes, sorry. It might be my end as well. So could you just elaborate briefly on your discussions with the FDA regarding frontline accelerated approval for PADCEV and I guess just how those have been going and potentially timelines, if available? And then could you just provide some comments around COVID and the impact that it's had to the PADCEV launch and then what sort of penetration that you guys have seen during the first quarter? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [20] -------------------------------------------------------------------------------- Okay. So first of all, Roger just gave an update on the frontline work we're doing in 150 patients for the accelerated PADCEV approach. And so he explained the 2 arms in his prepared remarks, 75 patients each. It's 150 patients. We started the enrollment in January. It's going well. We have not provided set timelines at this point. But our interaction with the FDA was strong, and we put out a press release on it. We -- I think at the end of the day, we've done this a lot with different drugs. We had 8 different approvals with drugs and labels. And I think we're pretty good at this, and we know what we need to bring to the FDA. But at the end of the day, it's always a review decision. The FDA looks at your data and makes a decision based on the data. So we will work forward fast. We'll be prepared, and we'll bring it to the FDA. And as we get further into the trial, we usually provide timelines, but not yet. As far as COVID-19 and PADCEV, we can't rule out that there wasn't an impact on COVID-19. It's impossible to rule that out. We had 2 months in the field, and then COVID-19 hit. And our salespeople switched to a virtual sales force, which actually helped train us to be fully ready for TUKYSA. We had 2 drugs getting approval 4 months apart, so -- but the second drug, TUKYSA, is purely virtual as far as communications with doctors, et cetera, and caregivers. But with PADCEV, while we can't rule it out that it had impact, we're very pleased with the $34 million in net sales. It means we've gone out there, and we've really got to a lot of patients. Doctors are using the drug. We hear really good things about it. We're certainly bullish on PADCEV going forward, not only in the relapsed setting like we have but also in first line and other settings. And we have not provided a market penetration number on this as of yet. These are things that we would decide in the future whether or not we would provide these type of guidance. -------------------------------------------------------------------------------- Operator [21] -------------------------------------------------------------------------------- We'll take our next question from Michael Schmidt with Guggenheim. -------------------------------------------------------------------------------- Michael Werner Schmidt, Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD [22] -------------------------------------------------------------------------------- Congrats on the terrific launch here as well of PADCEV. Maybe just a couple for Roger on additional labeling opportunities. The EV-201 cohort 2, can you just help us understand how big that incremental additional opportunity might be in bladder cancer? And then you mentioned the Merck collaboration for muscle-invasive bladder cancer patients. Can you just help us here what the potential path to market could look like? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [23] -------------------------------------------------------------------------------- Sure. Roger, go on ahead. -------------------------------------------------------------------------------- Roger D. Dansey, Seagen Inc. - Chief Medical Officer [24] -------------------------------------------------------------------------------- Sure. So thanks for the question. So as we've indicated, we've enrolled cohort 2. Cohort 2 is this group of patients on the EV-201 trial who are not cisplatin-eligible but have seen a PD-1 or PD-L1 inhibitor. That's a smaller population than the broader population, which are platinum-eligible and have seen a PD-1. Nevertheless, it's a meaningful -- it's a high unmet need. It's a meaningful population. So we're hopeful as the data matures and we're able to give you a little bit more guidance around timing. We've completed enrollment. This is, as is cohort 1 -- as was cohort 1, it's an overall response followed by duration of response evaluation. So we're hoping we'll get the results potentially later this year. But I think as we get more clarity on the timing, we'll give you more guidance. With regard to muscle-invasive bladder cancer, we're very pleased. As you know, we have 2 cohorts running in EV-103: one looking at PADCEV monotherapy and the other looking at PADCEV together with KEYTRUDA in cisplatin-ineligible patients with muscle-invasive bladder cancer. And essentially, by being able to join the Merck registrational trial, we've sort of leapfrogged our potential to get an approval in this very important group of patients. The end points, as defined by original negotiations between Merck and the FDA, focused on things like pathologic complete response and event-free survival. I think the details of how that trial has been altered to accommodate PADCEV and KEYTRUDA will become available through ct.gov (sic) [clinicaltrials.gov] or some other means. And once they are available publicly, I think we'll go into more detail for you. But that is an ongoing trial, which we are joining. -------------------------------------------------------------------------------- Operator [25] -------------------------------------------------------------------------------- We'll take our next question from Geoff Meacham with Bank of America. -------------------------------------------------------------------------------- Gregory Allen Harrison, BofA Merrill Lynch, Research Division - Research Analyst [26] -------------------------------------------------------------------------------- This is Greg Harrison on for Geoff. Just to dig into the guidance a little more. The fact that you maintained it across the board, definitely showed some confidence. So just wondering, what impact from COVID-19 is implied in your decision to maintain the guidance? And what sort of factors are in play, negative or positive, that give you confidence in that outlook, both in terms of ADCETRIS as well as expenses and your other guidance items? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [27] -------------------------------------------------------------------------------- Sure. Well, I'll address the ADCETRIS, and I'll let Todd address the expenses. So ADCETRIS is a great product. It's been out there approved since 2011. We have 6 labels, and it helps patients in many different ways. So doctors rely on it, depend on it, and patients benefit from it. And I think that when COVID first comes out and came out on to the scene, it was really hard, I think, for some docs and patients to really know exactly what to do. We were all a little bit stunned by the changes that happened so rapidly. And so I think that initially, it was not as clear. But it is really important for these patients to continue getting therapy and when they need therapy for cancer, getting therapy. It is really, really important. So I think that, over time, we've learned a little bit more and learned how to stay safe and wear masks and do other things. And so I think that right now, cancer patients are getting therapy and -- which is really important for cancer patients with life-threatening disease. And we see that strengthening and improving through the year. So I think staying with our guidance makes a lot of sense for us because there are patients that need therapy, and we think that largely, they're going to be getting their therapy. Todd, do you want to talk about expenses? -------------------------------------------------------------------------------- Todd E. Simpson, Seagen Inc. - CFO [28] -------------------------------------------------------------------------------- Yes. I'll first maybe start off by saying that we have really, as a management team, tried to focus on this and keep business interruption to an absolute minimum. Clay is right, when you look at what we're doing commercially, what we're looking at from a clinical trial perspective, our trials to cancer patients are important, and we have really done the best we can to keep the level of disruption on our trials down. Now when you look at our R&D expenses in the first quarter, if you annualize that, we're a little bit below our annual guidance. But I would point out that we've got a whole bunch of trials that are sort of in ramp-up mode now. And we're trying to keep that going as best we can. This includes the 301, the 302 and the 103 trials for EV, the TUKYSA combination trial with T-DM1, the MOUNTAINEER trial, the TV pivotal study. We've got a lot of potentially registration studies underway, and we've really done the best we can to keep moving forward as fast as we can and still doing it responsibly. -------------------------------------------------------------------------------- Operator [29] -------------------------------------------------------------------------------- Our next question comes from Chad Messer with Needham & Company. -------------------------------------------------------------------------------- Chad Jason Messer, Needham & Company, LLC, Research Division - Senior Analyst [30] -------------------------------------------------------------------------------- And let me add my congratulations on a really strong first full quarter for PADCEV. I don't think we expected you to get to this run rate for another few quarters at least. My question is on Nectin-4 expression. So in urothelial cancer, you're not enrolling any of these studies based on that, presumably because it's so ubiquitous. But are you collecting information on Nectin-4 expression and looking to see how it correlates to response in any of your studies? And sort of where I'm going is maybe that becomes more important as you look outside of urothelial cancer, just some other indications where it's not quite so ubiquitous and kind of wondering how you're handling that in your basket trial. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [31] -------------------------------------------------------------------------------- Yes. I'll make a quick comment and turn it over to Roger to talk about a lot of other factors. But very early on, we were looking -- when this product started years ago in Phase I, we'd looked at H-scores, which tells you how much Nectin-4 there is, and response rate. Now keep in mind that H-scores are -- is kind of a crude way to determine level of Nectin-4. It's not 100% precise, but it's pretty good, and it's quick and it's readily available. And it is ubiquitous in bladder cancer. And so we found pretty early on that it was very hard to see a correlation between the H-score per the histology to the response. So in that regard, we do not need a diagnostic tool for it in the metastatic setting. And I'll let Roger speak from there about any other thing in the basket trial, et cetera. -------------------------------------------------------------------------------- Roger D. Dansey, Seagen Inc. - Chief Medical Officer [32] -------------------------------------------------------------------------------- Yes, it's a great question. So really for all of our ADCs, we look, obviously, for the highest-expressing tumors. And so the basket trial, EV-202, has a group of cancers, breast, lung, head and neck, gastric cancer and so on, which has high Nectin-4 expression. But we are always prepared. So Nectin-4 expression is always measured. And if it turned out that actually a biomarker was relevant potentially in selecting patients who would respond, I think we would be ready for that. Our supposition is that, that will not be the case. There are components. For example, vedotin ADCs have bystander effect, so the drug can get -- can leak into a cell next door that isn't -- doesn't mark with a particular biomarker. But -- so our going-in premise is we will not need it, but we will be prepared if we do. -------------------------------------------------------------------------------- Operator [33] -------------------------------------------------------------------------------- We'll take our next question from Gena Wang with Barclays. -------------------------------------------------------------------------------- Huidong Wang, Barclays Bank PLC, Research Division - Research Analyst [34] -------------------------------------------------------------------------------- I have 2 parts of the question, first one is regarding the product class. Just wondering the strong revenue for the first quarter, was the script mainly driven by academic doctors? Or was that by the community doctors? And my second question is regarding the IP arbitration process. Just wondering how long it will usually take? And would there be multiple rounds of the process? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [35] -------------------------------------------------------------------------------- So first of all, concerning PADCEV, we are not, at this point, planning to outline what percentage is in academic settings and what percentage is in community settings. I think in the prepared remarks, Chip mentioned that a fair amount of the use is coming from community settings, which we're delighted with. So right now, we see script coming out of both academic and community settings. And we're very pleased with the uptake, and we look forward to having a great year of providing PADCEV to patients in need and to the doctors and supporting the doctors as they use PADCEV in patients that can really benefit from this exciting drug. So that's something we're going to continue. Maybe in the future, we'll be in a position to discuss the academic and community settings, but it's entirely too soon to really speculate and think about that. As far as the litigation, you -- I believe you asked a question about what we meant -- what we discussed with Daiichi Sankyo. Is that correct, Gena? Did you ask that? -------------------------------------------------------------------------------- Huidong Wang, Barclays Bank PLC, Research Division - Research Analyst [36] -------------------------------------------------------------------------------- Yes. Yes. So the arbitration process, just wondering how long usually would that take. And also, would there be multiple rounds? I know it's not a court process, but just wondering would that be -- is there like a certain timeframe? Should we expect that final results will be read out? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [37] -------------------------------------------------------------------------------- Okay. So we are not guiding to any specific timeframe for that. I appreciate the question very much. We're pleased that the ruling was to go forward in arbitration, keeping in mind that the deal we did basically said that if there was an issue like what has come up, that the correct approach and the right legal pathway forward based on the deal that we had with Daiichi Sankyo was to go through arbitration. And we believe that our case is very strong. We've mentioned this publicly before. We believe that they used our technology, and they made improvements, which was completely spelled out in the agreement to the products they have. And we believe we are correct in bringing this case forward and protecting our IP as appropriate. So we feel very strong about that. Going forward in arbitration is -- it's a more efficient and rapid path forward to a resolution rather than bringing it to a court case. And so we're very pleased that it is going through arbitration, and that's now started. And -- but other than that, it's a pending legal matter, and we really can't make comments. -------------------------------------------------------------------------------- Operator [38] -------------------------------------------------------------------------------- We'll take our next question from Joe Catanzaro with Piper Sandler. -------------------------------------------------------------------------------- Joseph Michael Catanzaro, Piper Sandler & Co., Research Division - VP & Senior Biotech Analyst [39] -------------------------------------------------------------------------------- Congrats on this nice PADCEV quarter. Just one question around it and maybe just to try and give us a sense of the trajectory moving forward. One thing we had heard even prior to COVID is that with PADCEV in the real-world setting, some physicians felt they had flexibility in how they dosed it given it's dosed every 3 weeks out of 4 to balance efficacy with the tolerability. Just wondering if you're sort of seeing that and whether you expect that to maybe pick up in light of the current environment to sort of maybe minimize patient visits and any sense around duration of treatment but realize it's early here. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [40] -------------------------------------------------------------------------------- So Joe, we haven't really seen what you're talking about. I could turn it over to Roger to comment on this, but we haven't seen doctors flexing to some other schedule. I mean we've done our -- we have our schedules, 3 weeks on and 1 week of holiday -- drug holiday, and that's our schedule. The duration also, we presented that with all of our data. And so we have some firm data on duration that we're very proud of, and it's an exciting and a great drug. I mean Roger, is there anything you want to add to that? -------------------------------------------------------------------------------- Roger D. Dansey, Seagen Inc. - Chief Medical Officer [41] -------------------------------------------------------------------------------- Yes, sure. So I think when you get into cancer medicine and a disease like bladder cancer, which can be -- is devastating, patients are very symptomatic, the demand to get the treatment for the plan is high. With the initial sort of onslaught of COVID, it may have taken some time for oncology clinics to work out how to manage through what a new schedule could look like and how to get patients' treatment. So most of the focus that I think we're aware of is that the clinics focus on giving treatment. They may struggle with off-treatment visits and so on, but getting the treatment is paramount. -------------------------------------------------------------------------------- Operator [42] -------------------------------------------------------------------------------- We'll take our next question from Andrew Berens with SVB. -------------------------------------------------------------------------------- Andrew Scott Berens, SVB Leerink LLC, Research Division - MD of Targeted Oncology & Senior Research Analyst [43] -------------------------------------------------------------------------------- And let me add my current congrats on the strong launch. You guys beat the Enhertu number, and we thought that was a great launch yesterday. Just wanted to get some more color on PADCEV uses, and it's really, I guess, one question with 3 parts. Should we think of the beat as being driven by more advanced patients that -- than you'll eventually get? I mean we've seen other launches that kind of roar out of the gate and then the duration of usage for the early patients drops off because they're more advanced. Just trying to see if that could be the case here. And then can you guys give us any color, are you seeing usage of PADCEV with KEYTRUDA? And then the last part is, are you getting patients that have the FGFR biomarker? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [44] -------------------------------------------------------------------------------- Okay. So thank you for your questions. And congratulations to you on putting 3 questions into one. It's very innovative. So as far as the advanced patients go, your comment on whether we've seen a lot of advanced patients, and we'll see a falloff and all that stuff, that is not where we feel we are. We feel this is being used broadly and will continue to be used broadly. We have a lot -- there's a lot of excitement for this drug going forward. And I think for anybody that has metastatic bladder cancer, according to the label, this treats anybody, whether you're advanced, more advanced or less advanced. Keep in mind that most patients with bladder cancer, to some extent, are advanced. It's a bad disease. And -- but whether they're earlier in that cycle or later in the cycle, all of them could benefit. And I don't -- I really can't make comments that we're just seeing one type of patient, I don't think that's happening. As far as the combination with KEYTRUDA, we're -- we loved our data. Our data was spectacular with that, which is why we started a global trial to do -- to look for frontline, which is also why we went to FDA early to say is there an expedited pathway to get to first-line in combination with KEYTRUDA. So we're doing both the full global trial as well as doing the expedited trial and -- with PADCEV. And as far as whether anybody is using PADCEV in combination with KEYTRUDA, we can't make any comments on that. That's not -- certainly not something that we're out there promoting for. We have clinical trials open right now. I think that we're encouraging people to sign up for trials to do that. And as far as the last question on FGF biomarker, we're very aware of that. It's not something that we're focused on, though. I mean that's a small subsection of bladder cancer. We basically have no -- there's no diagnostic tool. We can use everybody. So -- or we could treat everyone, I should say. And we're -- so we're looking at really just helping out as many patients as we possibly can and working with the doctors that make their therapy decisions. -------------------------------------------------------------------------------- Operator [45] -------------------------------------------------------------------------------- We'll take our next question from Stephen Willey with Stifel. -------------------------------------------------------------------------------- Stephen Douglas Willey, Stifel, Nicolaus & Company, Incorporated, Research Division - Director [46] -------------------------------------------------------------------------------- Congrats on the PADCEV launch. Just a couple of quick ones. I was wondering maybe if you can just talk a little bit about [CD30C] in terms of what's being used there to drive the improved tolerability that was referenced in the opening remarks. Is that a more stable linker? Is that a different payload? And then just curious regarding your publication plans, if there's any in the works for the EV-103 data in terms of the preliminary results that we've seen thus far. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [47] -------------------------------------------------------------------------------- Sure. I'll answer the CD30C question, and then Roger can opine on the EV-103 plans for publications, presentations, whatever. With CD30C, we decided that it was important to try to continue to innovate and continue to make as best a drug as we can for cancer patients, and CD30 is a target we know a heck of a lot about. This is something that we have studied for years. I think we're one of the top companies, if not the top company, in the world thinking about CD30 or CD30 therapy. And so I think that it's really important to think about continuing to get better and treat patients better. ADCETRIS is a phenomenal drug. But to try to improve outcomes for patients with CD30 malignancies is important for us. So we set out a few years ago to try to say how can we make a drug that can even give patients even better outcomes than what's already a really good drug in ADCETRIS. And it was hard. I mean we made a lot of different versions and just couldn't get any better than ADCETRIS for years and which tells you a lot about ADCETRIS and how good of a drug it is. So with CD30C, what I would say is it's different. It has different linkers, different payloads, different ways it's going to work, different ways it could combine with things. So in the laboratory setting and in animal models of cancer, we're really excited with it in the clinic. Whether this will prove to be better than ADCETRIS or different than ADCETRIS with different characteristics, we don't know yet, but we're excited to bring this forward and see how much we can work toward helping patients. So that's really what that's about. Roger, do you want to talk about EV-103 and plans? -------------------------------------------------------------------------------- Roger D. Dansey, Seagen Inc. - Chief Medical Officer [48] -------------------------------------------------------------------------------- Sure. Yes. So it's a great question, and it's under consideration because, as you know, the results were really quite remarkable. And we think that it could potentially be worthy of a publication, but I don't think a final decision has been made, but obviously, we'll update you if we make that call. -------------------------------------------------------------------------------- Operator [49] -------------------------------------------------------------------------------- We'll take our next question from George Farmer with BMO Capital Markets. -------------------------------------------------------------------------------- George Farmer, BMO Capital Markets Equity Research - Analyst [50] -------------------------------------------------------------------------------- Congratulations on PADCEV. It's fantastic to see. I actually have a question about ADCETRIS. And Clay, you mentioned that there's going to be some 5-year follow-up data coming. Do you expect that's going to move the needle with practitioners? And if so, how do you see that? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [51] -------------------------------------------------------------------------------- Thank you for the question, George. It's a good question. When we started and got our first approval in frontline Hodgkin lymphoma, a lot of docs saw the data, and they saw it was 2 years' worth of data, and the data were strong. But they said this is a disease we know how to treat for decades. They were using ABVD, and they had a lot of data. And the docs remarked to us that the 5-year data was the gold standard for this. And they really wanted to see the 5-year data and really know what's the durable, long-term, and they call it, cure rate. Now cure, I mean, we all die someday of something. But if you're 5 years' out, and you have no evidence of disease, doctors will talk to their patients, and they say you are disease-free, you are technically cured of your cancer because we have no evidence 5 years' out. So there's a defined cure for sure. But they've always said to us that the 5-year number was the gold standard. And I think that for anybody that is still on the fence or not considering it, I think the 5-year data absolutely could be interesting. Whether it will be a mad rush or something, we're not guiding to that, George, but I think it certainly could be important. The other thing is especially during the COVID era we're living in, having 5-year data with a regimen without bleomycin is important. Bleomycin causes lung scarring and gives you respiratory distress. And for somebody to have Hodgkin lymphoma, which is, in many circumstances, a curable disease by the definition I said, but to give them some pretty severe lung toxicity, I would not want a patient to have that and then be exposed to COVID because you could be much, much worse because of their lung scarring that you get and respiratory distress you get with bleomycin. So having this alternative that not only is better, you have a higher rate of -- we presented the 4-year data, in the 4-year data so far, a higher rate of disease-free survival by around 6% to 7% over ABVD and without the lung scarring of bleomycin. I think it's an important thing to think about in this COVID era that are working through and having the 5-year data would even be better. -------------------------------------------------------------------------------- George Farmer, BMO Capital Markets Equity Research - Analyst [52] -------------------------------------------------------------------------------- Yes. That makes sense. And then finally, can you talk a little bit about what the TUKYSA presentation will be discussing at ASCO in more detail? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [53] -------------------------------------------------------------------------------- Well, we can't tell you the whole presentation because that's for the ASCO virtual meeting. But Roger, can you give a little foreshadowing? -------------------------------------------------------------------------------- Roger D. Dansey, Seagen Inc. - Chief Medical Officer [54] -------------------------------------------------------------------------------- Sure. As HER2CLIMB was designed and as it was presented, we focused on the main end points, which were progression-free survival in the overall population, overall survival and then progression-free survival in patients with brain metastases. But important questions -- and that's the framework under which you understand the value and the benefit to patients. But important questions can still be answered by interrogating the data and focusing really on the outcome in the brain itself. And so we've done those analyses, and we've put together what we think is a coherent story to explain more clearly what the brain-specific outcomes will look like, and that's what we hope will be of value to everyone when it gets presented at ASCO. -------------------------------------------------------------------------------- Operator [55] -------------------------------------------------------------------------------- We'll take our next question from Andy Hsieh with William Blair. -------------------------------------------------------------------------------- Tsan-Yu Hsieh, William Blair & Company L.L.C., Research Division - Senior Research Analyst [56] -------------------------------------------------------------------------------- I hope everybody is staying safe and healthy, and congratulations on a spectacular quarter. So my question has to do with kind of the concurrent enrollment of the EV-103 cohort K and the pivotal EV-302, very similar patient population. Do you see kind of the enrollment tilt towards the cohort K just given that you have both options, which are chemotherapy-free versus EV-302 and, therefore, we should expect a really rapid enrollment timeframe. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [57] -------------------------------------------------------------------------------- So thanks for the question on the cohort K and the pivotal trial. Roger, can you explain what we're thinking of and looking there in the geographies, et cetera? -------------------------------------------------------------------------------- Roger D. Dansey, Seagen Inc. - Chief Medical Officer [58] -------------------------------------------------------------------------------- Sure. And Andy, it's a great question. And so to some degree, yes, cohort K would overlap with EV-302. But bear in mind, EV-302 is a very large trial, that is, we'll have a global footprint. EV-103 is more focused in places like the United States. And there are more than enough patients to enroll both of those trials. So we'll -- it's what we do all day, which is to manage trial recruitment and to make sure that trials are adequately supported for both of them. So I don't have any concerns that we'll be able to enroll both trials expeditiously, and that's what we plan to do. -------------------------------------------------------------------------------- Tsan-Yu Hsieh, William Blair & Company L.L.C., Research Division - Senior Research Analyst [59] -------------------------------------------------------------------------------- Got it. Okay. And then so it goes without saying that the company has executed to perfection in the past 2 years. And so it's welcoming to see in the presentation, you have some early-stage assets highlighted. Just curious, Clay, any assets heading into ASCO that you're particularly excited and just curious on your thoughts on the progress made in the SEA sugar-engineered platform and the CD40 asset that could be immune potentiating? -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [60] -------------------------------------------------------------------------------- Sure. So thank you very much for your remarks on how well the company has done over the last few years. We're focused on cancer patients. And we've been working really hard to help cancer patients, get drugs approved. Even during the COVID time, we have kind of rearranged the company for efficiency and people that can work from home are working from home, and we have even started to reopen under very strict guidelines our laboratories where we have social distancing and people with mask and gloves, but they're back in the laboratories and working. And our goal is to really work hard and execute well to make a difference in cancer patients' lives. And so we're making -- trying to make the right decisions and focusing on that. Now to your question on the early-stage assets, you bring up the SEA-40 program. That is a very exciting drug that we are developing. And you'll hear more data about that in the future. Right now, I don't want to disclose any data. It's not ready to be disclosed. We'll disclose it at the right time. But it's an exciting program. It's a non-ADC. We are doing more and more with non-ADCs, plus adding more ADCs. I think we mentioned that in the prepared remarks that there's both ADCs and non-ADCs. And certainly, our last approval in TUKYSA is a non-ADC, it's our first non-ADC approved. And so we're excited to make a difference in cancer patients. In any way when we work on targeted therapies, whether they're targeted to the cell surface or inside the cell. I think that our early-stage assets are very exciting. We have quite a lot of assets, and we don't talk about them too much until we have some real data to show. But I think over the next year or 2, you're going to hear a lot about our early assets, and I'm excited about them. -------------------------------------------------------------------------------- Operator [61] -------------------------------------------------------------------------------- We will take our next question from Silvan Tuerkcan with Oppenheimer. -------------------------------------------------------------------------------- Silvan Tuerkcan, [62] -------------------------------------------------------------------------------- Congrats on the quarter. I have a question on the PADCEV development in muscle-invasive setting. Since your clinical development moves so fast, I just want to make sure that I don't look track here. So first, would EV-103 and the amended Phase III now be enough to file? And second of all, I think it's a pretty big deal that Merck amends an ongoing Phase III to include PADCEV even prior to seeing the 103 data. Could you give a little bit more color on how did this happen? And does it mean that Merck will use the combo as potential new standard of care in this setting here? That's all. -------------------------------------------------------------------------------- Clay B. Siegall, Seagen Inc. - Co-Founder, Chairman, President & CEO [63] -------------------------------------------------------------------------------- Well, first of all, thank you for your very insightful question about this. And we really can't comment on Merck and what their thoughts are and whatever. We can tell you what the trial is and what we're doing and what we're attempting to do and why we're going after this. And Roger, maybe you could give a little color on muscle-invasive bladder cancer and why this is important. But I'm sorry, I just can't comment and we can't comment on what Merck or any company is thinking at this time. -------------------------------------------------------------------------------- Roger D. Dansey, Seagen Inc. - Chief Medical Officer [64] -------------------------------------------------------------------------------- Yes. Sure. So it's -- again, it's a great question. And I think the excitement around combining an ADC with a vedotin warhead, which has been shown to not only kill cancer cells and kill them well in bladder cancer but also set up an immunogenic cell death environment that is potentially -- that could help a PD-1 inhibitor with an improved immune response, so combining those 2 and the data that we generated out of EV-103 with the cis-ineligible frontline, I think, gives us conviction that we should take this combination forward as appropriate. And of course, we are still executing a small cohort in EV-103, but the opportunity to join an already established registrational trial and taking this combination together into a muscle-invasive setting, we think, is really opportune for us. And Nectin-4 expression is consistent across all of the stages of bladder cancer, all the way from advanced metastatic disease back into the nonmuscle-invasive bladder cancer and in muscle-invasive bladder cancer. So there's no reason to believe that somehow PADCEV will behave differently in this disease setting. Merck has already generated data with pembrolizumab, which -- with KEYTRUDA, which is pretty exciting. So taking these 2 active agents and combining them in this population, for which really there is no therapy apart from cystectomy, we think is an important potential step forward. -------------------------------------------------------------------------------- Operator [65] -------------------------------------------------------------------------------- It appears there are no further questions at this time. Ms. Pinkston, I'd like to turn the conference back to you for any additional or closing remarks. -------------------------------------------------------------------------------- Peggy Pinkston, Seagen Inc. - VP of IR & Executive Director of Corporate Communications [66] -------------------------------------------------------------------------------- Okay. Thank you, operator, and thanks, everybody, for joining us this afternoon. Be well. -------------------------------------------------------------------------------- Operator [67] -------------------------------------------------------------------------------- That concludes today's presentation. Thank you for your participation. You may now disconnect.