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Seattle Genetics (NASDAQ:SGEN)
Q1 2021 Earnings Call
Apr 29, 2021, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Operator

Good day and welcome to Seagen first-quarter 2021 financial results conference call. [Operator instructions] After today's presentation, there will be an opportunity to ask questions. Please note, this event is being recorded. I would now like to turn the conference over to Peggy Pinkston, senior vice president of investor relations.

Please go ahead.

Peggy Pinkston -- Senior Vice President of Investor Relations

Thank you, operator, and good afternoon, everyone. I'd like to welcome all of you to Seagen's first-quarter 2021 financial results conference call. This afternoon, we issued a press release with our results. The press release and supporting slides are available on our website in the investor section, events and presentations page.

Speakers on today's call 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 one hour and to ask that you limit yourself to one question to give everyone an opportunity to participate in Q&A during our call today. Today's conference call will include forward-looking statements regarding future or anticipated events and results, including the company's 2021 financial outlook, anticipated product sales, revenues, costs and expenses, and potential clinical and regulatory milestones, including data readouts, regulatory submissions, and approvals.

Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the difficulty in forecasting sales, revenues, and expenses, impacts related to the COVID-19 pandemic, and the uncertainty associated with the pharmaceutical development and regulatory approval process. More information about the risks and uncertainties faced by Seagen is contained under the caption risk factors, including the company's annual report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission, and the company's subsequent reports filed with the SEC. And with that, I'll turn the call over to Clay.

Clay Siegall -- President and Chief Executive Officer

Thank you, Peg, and good afternoon, everyone. Following a transformational 2020, we continue to make substantial progress in the evolution and global expansion of our business. We remain focused on investments to maximize the opportunity and value of our assets, fueling our ability to advance cancer care worldwide. We look forward to sharing key business, regulatory, and development progress on the call today.

We reported a record net product sales of $303 million in the first quarter, representing 3% sequential quarterly growth and 52% growth over the first quarter of 2020. These results reflect rapid adoption of both Padcev and Tukysa on top of strong sales of Adcetris. Our financial strength is driven by product sales, as well as royalties and multiple strategic collaborations. We ended the quarter with $2.5 billion in cash and investments which positions us to expand our programs, advance our research and development, and invest in our business.

As we look ahead, we're focused on three strategic priorities to drive continued innovation and growth. Focusing on these key pillars will ensure our organization is aligned and empowered to deliver substantial benefit to shareholders, our employees, oncology healthcare providers, and especially cancer patients. Our first strategic priority is to maximize the global potential of our three approved medicines through robust clinical development programs and exceptional commercial execution. I'll begin with Adcetris, a remarkable product that is the foundation of care in multiple CD30 expressing lymphomas.

With six indications in the U.S., Adcetris serves as the basis of our core business. Adcetris is commercially available in 76 countries. Importantly, our partner, Takeda, continues to pursue additional approval for frontline Hodgkin lymphoma and peripheral T-cell lymphoma in its territories. We are committed to maximizing Adcetris as patient reach and are advancing a clinical development program in Hodgkin lymphoma and multiple other malignancies.

Our global success with Adcetris is enabling us to continue investing in our pipeline in newer medications. Our next key product is Padcev, a first in class ADC that has quickly become standard of care in previously treated metastatic urothelial cancer. Locally advanced and metastatic urothelial cancer is an aggressive disease with poor survival, high associated healthcare costs, and limited treatment options. Padcev is the first drug to improve survival after patients have received a platinum chemotherapy and a checkpoint inhibitor.

Since the beginning of 2021, we've made substantial progress with health authorities toward expanding the U.S. label and securing global approvals across Europe, Asia, and Latin America. Roger will share details about these activities during his remarks. We're also advancing two trials designed to redefine frontline treatment for metastatic urothelial cancer patients globally with a focus on the combination of Padcev and Keytruda.

And we continue to make significant headway in exploring earlier stages of bladder cancer. In collaboration with Astellas and Merck, Padcev is being tested in two randomized phase 3 trials in muscle-invasive bladder cancer patients and intend to initiate an exploratory study of Padcev in non-muscle-invasive bladder cancer. Our third key product is Tukysa, a best-in-class HER2 tyrosine kinase inhibitor for HER2 positive metastatic breast cancer patients with and without brain metastasis. Tukysa is now approved in 36 countries.

In February, the European Commission approved Tukysa in the EU and the regulators in the U.K. granted its marketing authorization in Great Britain. This is a significant milestone for patients in Europe who, for the first time, have an approved medicine that has demonstrated a survival benefit for HER2 positive metastatic breast cancer after disease progression following two anti-HER2 treatment regimens. In anticipation of these approvals, over the past year, we've established affiliates in key European countries and build teams with deep industry experience.

We recently launched Tukysa in Germany, France, and Austria. We're pleased by the early uptake, physician's feedback, and that Tukysa has already been included in some key treatment guidelines given the strength of clinical evidence. Through our expanded European footprint, we're poised to execute upon another upcoming Tukysa launches and collaborate with individual countries to maximize its ability, availability, and patient access. In addition to this commercial progress, we are conducting a broad political development program designed to maximize Tukysa's potential, including trials evaluating it in HER2 positive breast, colorectal, and gastric cancers, and in HER2 mutant tumors.

Our second strategic priority is to advance our late-stage programs toward securing approvals for new products. One such asset is Tisotumab Vedotin or TV. Earlier this month, FDA accepted proprietary review or BLA, seeking accelerated approval for TV with an action date of October 10. The submission comprised data from innovaTV 204 pivotal phase 2 trial, which was presented at ESMA and was recently published in The Lancet Oncology.

This is an important development in the treatment of cervical cancer, which remains one of the leading causes of cancer death in women globally. TV is positioned to be our fourth commercial product as we look to expand our portfolio further. And together with our partner, Genmab, we are preparing for its launch. Our third strategic priority is to advance our innovative early stage pipeline through continued leadership and innovation in antibody-drug conjugates, internal R&D investments, and corporate development opportunities.

Our earlier stage pipeline includes seven programs in clinical trials and multiple preclinical assets advancing toward the [Inaudible]. I'm proud of the remarkable progress we've made in growing and evolving our business and assets to better meet the needs of cancer patients. Next, I'll turn the call over to Chip who will discuss our commercial business. Then, Todd will provide an overview of our quarterly financial results.

After that, Roger will detail our clinical development and pipeline progress. Chip?

Chip Romp -- Executive Vice President, Commercial U.S.

Thanks, Clay. Our three approved products are important first-in-class or best-in-class medicines that have been embraced by oncologists and patients. We believe that each of the brands have blockbuster potential and we continue to invest in our commercial capabilities to ensure we can maximize the opportunity to gain future approvals and label expansions. We are engaging with our customers through multiple channels and are pleased that most of our sales representatives have been able to safely return to making face-to-face calls.

Adcetris' sales were $163 million, a 1% decline versus Q1 2020. The COVID-19 pandemic continues to impact Hodgkin lymphoma diagnosis. But we are seeing early signs of recovery. And despite this headwind, we've maintained share in our frontline indications.

We are monitoring these trends and it is our expectation that diagnosis rates will return to historic norms. We continue to message the landmark five-year ECHELON-1 progression-free survival data in frontline Hodgkin lymphoma. We are encouraged by the favorable reaction to the data we received during recent market research with physicians. Moving on to Padcev.

First-quarter sales were $70 million, double the first quarter of 2020. We were pleased with our quarterly growth after a strong launch. Our efforts continue to focus on promoting the full breadth of the Padcev label. The locally advanced metastatic urothelial cancer marketplace is rapidly changing, and we are confident that Padcev is well-positioned this year for continued growth as the market evolves.

Our sales representatives have been proactive in educating healthcare providers on our label update and customer sentiment remains positive on Padcev's risk-benefit profile. Transitioning to Tukysa. First-quarter sales were $70 million, an increase of 14% over last quarter. These results are in line with our expectations given the challenging Q1 patient popu dynamics of oral oncolytics.

We continue to gain market share in both patients with and without brain metastasis. Tukysa provides an overall survival benefit for patients with and without brain mets. And we are confident that we can continue to drive share gains for all patients. Tukysa is now the most utilized product in second and later lines for HER2 positive breast cancer patients with brain mets.

And finally, we are very pleased to receive a priority review for TV. A brand team is in place and we are working closely with our co-promotional partner, Genmab. We will be ready for a launch ahead of the October 10 PDUFA date. If approved, this would be an important new drug for women with metastatic cervical cancer, and we look forward to adding it to the proven Seagen commercial model.

Now, I'll hand it over to Todd.

Todd Simpson -- Chief Financial Officer

Great. Thanks, Chip, and thanks, everyone, for joining us on the call this afternoon. Our financial results for the first quarter reflect significant progress across the business. I'll briefly summarize our financial results for the quarter which are in line with our expectations for the full year.

Total revenues were $332 million in the first quarter of 2021. This included net product sales of $303 million from Adcetris, Padcev, and Tukysa, representing growth of 52% over the first quarter of 2020. Growth in product sales is driven by the continued strong uptake of Padcev and Tukysa since their launches in the U.S. Royalty revenues in the first quarter of 2021 increased to $27 million, compared to $20 million in the first quarter of 2020.

This growth reflects royalties earned on increasing sales of Adcetris by Takeda, as well as royalties on sales of Polivy by Roche and Blenrep by GSK. Collaboration revenues were $2 million in the first quarter of 2021, compared to $16 million in the first quarter of last year. As discussed when we gave our 2021 financial guidance, collaboration revenues are primarily driven by progress dependent milestone payments from our collaborators which causes quarterly variations in revenue. In the future, we expect collaboration revenues to reflect the profit share from Astellas from sales of Padcev in its territories.

Cost of sales in the first quarter of 2021 increased to $64 million. This included product costs of sales and royalties for each of our three brands, the Padcev profit share of $33 million to Astellas, as well as non-cash amortization of acquired technology costs for Takeda. R&D expenses increased to $230 million in the first quarter of 2021. This reflects continued investment across our pipeline to drive progress of our late and early stage pipeline.

SG&A expenses increased to $160 million in the first quarter of 2021. This reflects commercialization efforts related to the launch of the Padcev and Tukysa in the U.S., as well as investments to support the launch of Tukysa in Europe. We ended the first quarter with $2.5 billion in cash and investments and we have no debt. This positions us strongly to advance our plans in 2021 and beyond.

And lastly, our financial guidance for 2021 is unchanged. With that, I'll now turn the call over to Roger.

Roger Dansey -- Chief Medical Officer

Thank you, Todd, and good afternoon, everyone. I'm happy to share today key R&D activities for our approved medicines, as well as our pipeline programs. I'll start today with Padcev. As a reminder, Padcev has accelerated approval in the United States for metastatic urothelial cancer patients who have previously received both platinum-based chemotherapy and the checkpoint inhibitor.

The randomized phase 3 EV-301 trial, which compared Padcev to chemotherapy in this setting, demonstrated a clinically meaningful and statistically significant 30% reduction in the risk of death among patients who received Padcev. These data were presented at ASCO-GU and simultaneously published in The New England Journal of Medicine. The EV-301 data were also submitted to FDA in a supplemental BLA under the Real-Time Oncology Review and Orbis Programs. And this month, the application was accepted for priority review with a PDUFA date of August 17.

This application seeks to convert Padcev's accelerated approval to regular approval and integrate into the label the important overall survivor data that Padcev has demonstrated. To address the potential for Padcev in metastatic patients supersedes a checkpoint inhibitor and are cisplatin-ineligible, we conducted Cohort 2 of the EV-201 clinical trial. Positive data from this cohort were presented at the ASCO-GU meeting in February. Earlier this month, FDA accepted our supplemental BLA to potentially expand the U.S.

label to include this population. The application is also being reviewed under RTOR and has been given priority review with the same PDUFA date of August 17. An abstract, including additional follow-up data from Cohort 2, will be reported at ASCO in June. Our strong Padcev data have enabled substantial regulatory progress outside of the United States.

In the past two months, we and Astellas have engaged with eight regulatory authorities around the world and marketing applications are currently under review, including in Australia and Canada, with Health Canada signing priority review, in the EU where the application has been assigned to accelerated assessment. Importantly, this could shorten the time to approval. And lastly, in Japan, Brazil, Switzerland, and Singapore. We continue to advance the substantial Padcev clinical development program, which includes two trials that could support approval in first-line metastatic urothelial cancer.

We expect to complete enrollment of Cohort K of the EV-103 trials in cisplatin-ineligible patients receiving Padcev plus Keytruda by the end of this year. And if data are supportive, we plan to submit a supplemental BLA after appropriate follow-up for duration of response. In addition, we continue to enroll patients into the phase 3 EV-302 global trial, which includes both cisplatin-eligible and ineligible patients, evaluating Padcev plus Keytruda compared to a platinum-containing chemotherapy regimen. These trials are supported by initial data from the EV-103 trial which resulted in breakthrough therapy designation.

Updated durability results and long-term outcomes from these initial data will be presented at ASCO. As we move Padcev into earlier stages of bladder cancer, two phase 3 trials are enrolling patients with muscle-invasive disease. Both trials utilized Padcev in combination with Keytruda. The KEYNOTE B15 trial, also called EV-304, is enrolling cisplatin-eligible patients, and KEYNOTE 905, also called EV-303, is enrolling cisplatin-ineligible patients.

Additionally, we continue to work to bring Padcev into a clinical trial for non-muscle-invasive bladder cancer patients and have completed our initial regulatory discussions with the FDA. In summary, we are making great progress with Padcev. Turning now to Tukysa. The development team is advancing a similarly broad clinical program to support label expansions in breast cancer and investigate Tukysa in other HER2-positive cancers.

In breast cancer, we are evaluating Tukysa plus Kadcyla in first and second-line metastatic patients in the HER2CLIMB-02 trial. Additionally, we are pleased to report that the first patients was recently enrolled in the randomized COMPASS HER2 RD trial being run by the Alliance Cooperative Group, evaluating Tukysa plus Kadcyla in high-risk adjuvant breast cancer patients. In GI cancers, we are on track to complete enrollment in the MOUNTAINEER trial by the end of 2021. This trial is intended to support accelerated approval in the United States for patients with advanced surgery-positive CRC.

Also, we are advancing Tukysa in several exploratory studies, including in combination with an obsolete platinum-based chemotherapy regimen in first-line GI cancers, in a basket trial for solid tumors with HER2 alterations that include mutations and in combination within HER2 for HER2-positive breast cancer. Moving on now to Adcetris. We are excited that the ECHELON-1 five-year manuscript has now been accepted and we anticipate publication in the coming weeks. Results demonstrated robust and durable remissions in patients with newly diagnosed advanced Hodgkin lymphoma who received Adcetris in combination with AVD.

Five years free of disease progression is a clinically meaningful and important milestone in a cancer patient's journey. Going forward, we continue to invest in the development of Adcetris with several ongoing clinical trials. Notably, we have a randomized phase 3 trial in diffuse large B-cell lymphoma, exploratory evaluations of Adcetris plus nivolumab plus AD in frontline advanced and early stage Hodgkin lymphoma. And we are exploring Adcetris in combination with Keytruda as an immunomodulatory agent in solid tumors.

Now, I would like to turn to our late-stage program, Tisotumab Vedotin, which we are developing in collaboration with Genmab. Earlier this month, we announced that FDA accepted our BLA seeking approval of TV for treatment of women with recurrent or metastatic cervical cancer. The FDA has assigned a priority review and the PDUFA action date is October 10. We believe TV could make a meaningful difference to these patients where there is such a high unmet needs.

We also recently initiated the innovaTV 301 global phase 3 trial in a similar population of recurrent or metastatic cervical cancer patients that is intended to support global regulatory applications and serve as a confirmatory trial in the United States. Turning now to Ladiratuzumab Vedotin. We continue to work with our partner, Merck, to co-develop LV as monotherapy and in combination with Keytruda in LIV-1 expressing solid tumors. Our clinical development program is focused on optimizing dose and schedule as monotherapy and in combination with Keytruda in breast cancer.

A basket trial is also currently enrolling patients with lung, head and neck, prostate, esophageal, gastric cancer, and melanoma. Across the rest of our pipeline, I'd like to summarize a few recent highlights. At the AACR meeting in early April, we presented several compelling preclinical data sets from our phase 1 clinical programs. This included SEA-TGT where we showed the enhanced anti-tumor activity when combining SEA-TGT with a checkpoint inhibitor or of a vedotin-based ADC.

In addition, we described encouraging preclinical data with SGN-B6A and SGN-STNV, both of which are novel vedotin-based ADCs that have recently entered the clinic. We also entered into a clinical trial collaboration with Pfizer, under which will evaluate SEA-TGT in combination with sansanlimab, their subcutaneous PD-1 inhibitor. The combination will be evaluated as part of our ongoing phase 1 SEA-TGT trial in advanced solid tumors and lymphomas. And lastly, we completed enrollment in our clinical trial evaluating SEA-CD40 as part of a combination regimen for the treatment of pancreatic cancer.

We expect to report clinical data from the trial sometime later this year, which will inform next steps with as novel effector function enhanced non-fucosylated antibody that binds CD40. In closing, we have achieved many important milestones and have made significant progress across our pipeline in the first quarter of 2021. We look forward to providing you with further updates as the year progresses. And now, I will turn the call over to Clay.

Clay Siegall -- President and Chief Executive Officer

Thank you, Roger. The past year has been pivotal for Seagen and the company is well-positioned for the future. Today, we have a deep and diverse pipeline, a multi-product commercial portfolio, and additional potential approvals on the horizon. Additionally, we have powerful partnerships, a broad geographic footprint, and substantial financial strength to maximize our assets from our early stage pipeline to our expanding portfolio of approved medicines.

The solid foundation we have built sets the stage for Seagen's next phase of innovation and execution. I'm confident in our ability to continue delivering cutting-edge innovation and medicines that make a meaningful difference to the lives of cancer patients. I would like to thank everyone listening to this call for your continued interest in Seagen. Operator, please open the line for Q&A.

Questions & Answers:


Operator

We will now begin the question-and-answer session. [Operator instructions] Our first question comes from Geoff Meacham from Bank of America. Please go ahead.

Greg Harrison -- Bank of America Merrill Lynch -- Analyst

Hey, guys. This is Greg Harrison on for Geoff. Thanks for taking our question. The question is what sort of position reception have you seen with respect to Padcev after the cases of Stevens-Johnson Syndrome that came out.

On our end, we've heard [Inaudible] saying it won't affect prescribing much and they can screen out the high-risk patients. But just wanted to see what you guys are hearing on your end.

Clay Siegall -- President and Chief Executive Officer

So, Greg, thank you for the question. You know, Padcev has really delivered a very strong launch with rapid penetration into our label indications following its approval right at the end of 2019. So really, full year of 2020. You know, the -- concerning the -- the label, safety is always a top priority for us.

And label updates inform physicians on what to do and how to work with patients to prevent anything from happening. Our sales reps have been educated, healthcare professionals have been updated and educated, and physician sentiment remains very positive on the risk-benefit profile, the very positive risk-benefit profile with Padcev. It has not been an impediment to adoption. It is a very rare occurrence, and it has not changed practice on use of Padcev.

Roger, did -- did you want to add anything to that?

Roger Dansey -- Chief Medical Officer

Thanks, Clay. So the label, you know, initial -- skin reactions have been part of the Padcev's safety profile for some time. And so this was an important sort of post-marketing observation that was just extended into the label. So, you know, from the beginning, we -- we message very carefully around safety.

It's important. Most of the side effects are transient and reversible. And, you know, we're -- we think it's -- it's valuable for physicians to understand this. So, again, from a medical perspective, this does not change the risk-benefit for Padcev and we believe it will continue to be used.

And we certainly haven't changed any of our clinical trial plans.

Greg Harrison -- Bank of America Merrill Lynch -- Analyst

Great. Thank you.

Operator

The next question comes from Matthew Harrison from Morgan Stanley. Please go ahead.

Connor Meehan -- Morgan Stanley -- Analyst

Hi, Clay and team. This is Connor on for Matthew. So on KEYNOTE, could you comment on the outlook for the Keytruda combination and I guess how quickly you could move that into a registrational program? And then quickly, are you seeing any competition from Trodelvy, and what are your expectations for the impact on that drug to pass up? Thank you.

Clay Siegall -- President and Chief Executive Officer

OK. Thank you. So two completely different questions. One is on TV plus Keytruda.

So let's start with that. So we're very pleased with how TV is moving along. You know, as we said, we took Tisotumab Vedotin, or TV, and we have submitted it and we now have a PDUFA date. We have, you know, with, you know, the accelerated approval timelines.

So we're pleased with that. And, you know, the current therapies for metastatic cervical cancer are -- are really poor. They're generally with response rates of less than 15%, median OSs between six and nine and a half months. So it is a significant unmet need, certainly in the U.S.

and around the world, incredibly significant. And so our program includes a big part of it which is combining with Keytruda and chemotherapy. So we have multiple arms there. And -- and that's in earlier lines of cervical cancer.

And so we're very pleased with the success there, of getting patients to the trials and, you know, putting together a real opportunity there where we have not presented any data yet, but the trials have been going very well and we will be at an appropriate time presenting the data and information on these and making decisions to, you know, whether or not you go to a pivotal trial. It's my hope that we see great data and we go into a pivotal trial to try to get -- to try to get the kind of data that you could submit for earlier stage cervical cancer which could be really beneficial to patients and also a substantial market. Roger, do you want to add anything to what we're doing with a TV and Keytruda?

Roger Dansey -- Chief Medical Officer

So, Clay, exactly as you say, we have a monotherapy path for approval, which is currently under review, and that same monotherapy in late-line cervical cancer with a global trial that's running. But, of course, our interest is in combinations as well in order to move into earlier lines of therapy. And I think we're well-positioned with regard to the way we're evaluating combinations of chemotherapy and Keytruda such that if we do get positive readouts, we can take those combinations forward into further clinical development.

Clay Siegall -- President and Chief Executive Officer

So your second question is about competitive impact of Trodelvy. First of all, I want to say that we are very pleased that there are more options for patients. We are very patient-friendly company and think about how best, you know, providers and doctors can -- can treat patients with life-threatening diseases. So the more, the better for patients.

Second of all, Padcev has become the standard of care and its approved indications. And it's really firmly entrenched in the metastatic urothelial setting post-platinum, post-PD-1. And Padcev has shown OS benefit. And, you know, it is -- we're very pleased with where Padcev is in the lineup.

And, Roger, you may be able to discuss any updates or thoughts con -- connected with that.

Roger Dansey -- Chief Medical Officer

Sure. So, you know, as Clay indicated, you know, the more treatments that are available for patients, the better. However, the Padcev program, which is substantial, has already created, you know, the -- the use of Padcev in a specific line of therapy, and it is, as you say, essentially a standard of care, which is difficult to displace. So we're glad that Trodelvy is there.

However, we do see Padcev have -- having a very strong -- very strong value proposition.

Operator

The next question comes from Salveen Richter from Goldman Sachs. Please go ahead.

Salveen Richter -- Goldman Sachs -- Analyst

Thank you. Maybe just a question on Tukysa here. You know, they've got it as most utilized product in second-line-positive HER2-positive patients with brain met. Can you just comment on what you're seeing in the same setting in patients without brain met?

Clay Siegall -- President and Chief Executive Officer

Sure. So thanks for the question on Tukysa. As you know, Tukysa is approved for patients with visual disease, as well as patients with -- with brain mets. And we are certainly using it in both patients and getting a lot of uptake there.

Chip, could you comment a little bit on the dynamics in the market of using Tukysa in -- in brain mets and in patients with visual disease?

Chip Romp -- Executive Vice President, Commercial U.S.

Yeah, thanks, Clay, very much. So we're pleased with the progress that Tukysa is making. We're seeing both increased utilization in patients with and without brain metastasis. And as I mentioned earlier in the reading, we're now the most used product in second line and beyond for people with brain mets.

So again, uptake has been robust on -- on visual ones as well. And it continues to grow.

Salveen Richter -- Goldman Sachs -- Analyst

Thank you.

Operator

The next question comes from Cory Kasimov from J.P. Morgan. Please go ahead.

Turner Kufe -- J.P. Morgan -- Analyst

Hey, good afternoon. This is Turner on for Cory. Thanks for taking my question. So just one on the phase 1 SEA-CD40 study.

And, you know, as you mentioned in the prepared remarks, enrollment completed with around 159 patients across a bunch of different tumor types. Can you just give us a sense of how many tumor types moved into expansion cohorts or was it just pancreatic cancer? And also, just assuming you see signals with indications like pancreatic later this year, what do you see as potential next steps? Thanks.

Clay Siegall -- President and Chief Executive Officer

Sure. So I have in previous calls talked about my interest in working on pancreatic cancer. It's just such a huge unmet medical need and how that's something that I -- I felt as a cancer biologist and so in making cancer drug. And I was really hopeful that we can make an impact on pancreatic cancer patients.

So certainly, that's been an important part of this study. Roger, can you talk a little bit about where we are with SEAS -- SEA-CD40, you know, our plan. And, you know, later on this year, we are, you know, planning to have data. We -- I think we committed to presenting data for SEA-CD40 sometime this year.

Now, that does not mean that we're going to wait to making programmatic decisions before this day is presented. We can make programmatic decisions at any time and meet with regulators at any time and try to go forward on this really emerging exciting program. But, Roger, can you talk a little bit about what we're -- we're looking at in our arms before making any decisions on pivotal trials.

Roger Dansey -- Chief Medical Officer

Sure. So the CD40 program began as essentially a monotherapy program. We have an active agent. We have responses based on monotherapy.

We then pivoted the program for monotherapy into a combination approach. And that initial focus is in pancreatic cancer. So as Clay alluded to, we are interested in testing CD40 plus chemotherapy plus a PD-1 inhibitor in frontline pancreatic cancer. And that's the data that we will be focusing on.

However, from a biologic and sort of scientific perspective, we are interested in the construct of combining a CD40 agonist together with some form of cell killing through chemotherapy together with a PD-1 inhibitor. So we are working on plans potentially to look at other possibilities for further CD40 development. But the initial focus in the combination space is pancreatic cancer.

Turner Kufe -- J.P. Morgan -- Analyst

Thanks. Appreciate it.

Operator

The next question comes from Michael Schmidt from Guggenheim. Please go ahead.

Michael Schmidt -- Guggenheim Partners -- Analyst

Hey, guys. Thanks for taking my question. I had another one on the early stage pipeline, specifically on the TIGIT antibody. It looks like other TIGIT antibody -- antibodies have had rather a similar single-agent activity in phase 1 studies with a few [Inaudible] responses seen there.

I guess, to what degree would -- would you expect an antibody like yours with enhanced effector function to potentially improve upon these competitive molecules?

Clay Siegall -- President and Chief Executive Officer

So thank you for the question on our SEA-TGT. So we, you know, we're just studying it now. So we've not reported any data at this point. But preclinically, we saw that we had a very high effector function because it uses our SEA technology, which we've talked about before how that augments effector function while decreasing the inhibitory effector function.

So I'm not going to go through all that again since I've talked about it a lot. But we are very excited to take our drug into clinical trials. You know, the hope with any drug is this is single-agent activity. And then the hope with any drug is that not only does it work in single-agent activity, but it works in combination.

And so we have a lot of plans on what to do in combination with PD-1 inhibitor and as a single agent. And so we're working on advanced solid tumors and lymphomas and we are -- we're cranking forward as I look forward to a time where we're presenting data.

Michael Schmidt -- Guggenheim Partners -- Analyst

OK, thank you.

Operator

The next question comes from Andrew Berens from SV -- SVB Leerink. Please go ahead.

Andrew Berens -- SVB Leerink -- Analyst

Thanks. I wanted to see if you guys would give us some color about the presentation. I guess, is Cohort K that's going to be at ASCO, will be a larger sample size than what you presented previously or will be the same 45 patients with a longer follow-up?

Clay Siegall -- President and Chief Executive Officer

You know, I'll -- I'll turn it over to Roger for that. Roger, how about you addressing that?

Roger Dansey -- Chief Medical Officer

Yeah, yeah. So, Andy, thanks for the question. It's actually Cohort A. So it's the -- it's the original dataset, some 45 subjects that, you know, we saw that initial remarkable signal.

And the data we presented has been mature. It's even more mature now, and we're excited to bring that forward so you can see what the -- what long-term outcomes will look like with this combination of Padcev plus Keytruda in cisplatin-ineligible patients with frontline metastatic urothelial cancer. So it's not Cohort K, it's Cohort A.

Andrew Berens -- SVB Leerink -- Analyst

OK. Thanks. Appreciate it.

Operator

The next question comes from Kennen MacKay from RBC Capital Markets. Please go ahead.

Kennen MacKay -- RBC Capital Markets -- Analyst

Hey, guys, congrats on the quarter. An elaboration on a prior question and then a separate question. Roger, in call, you've mentioned completing that SEA-CD40 study in pancreatic cancer that'll be ready this year and -- so it has seems like you're excited about this one. But just hoping you can contextualize a little bit more.

You know, what -- what is the way here, being stable disease enough to -- to get excited in pancreatic cancer, getting this huge, huge, huge unmet medical need that was mentioned or -- or do you really need to see responses to -- to really help conviction there? And then just on Padcev. Wondering if you could help us with the breakdown, like the bladder cancer market and the incremental size of that metastatic -- the locally advanced Padcev market that was previously treated that the PD-1 and PD(L)-1 but is ineligible for cisplatin. Just trying to think about the incremental add from that sBLA that we're expecting to come online later this year. Thank you.

Clay Siegall -- President and Chief Executive Officer

Sure. Why don't we started with the bladder market? And, Chip, can you talk a little bit about the question Kennen -- Kennen asked about what we can expect with the potential additional market?

Chip Romp -- Executive Vice President, Commercial U.S.

Yeah, absolutely, Clay. This is a smaller segment of the population. But nevertheless, I think a meaningful number of patients. There is an important unmet need given these are typically older patients.

They suffer from multiple comor -- comorbidities like poor kidney function. We are already seeing some unfamiliar utilization, but we think there is a remaining opportunity once we get label to promote to.

Clay Siegall -- President and Chief Executive Officer

So going to your question on pancreatic cancer, Kennen. You know, there are a lot of things you can look at. Now, the study we have, you know, enrolled and we'll be presenting data on will provide us a lot of information on ORR, objective response rate. And just for reference, the Gem Abraxane OOR is about 23% in their phase 3.

And so if we came in at 24%, it's not going to be meaningful. So it has to be substantively above the 23%. Second of all, we want to look at the duration of response. We do that with every drug we do.

Whatever disease it is, we look at duration of response. And you don't want a duration that's super short because that doesn't really help patients. It's not that meaningful. And, you know, the regulators also want to see duration.

So we want to see it for ourselves in this lead-in trial. And then, you know, the other thing is we want to, you know, try to take an initial look at, saying what is, you know, can we learn anything about OS? You know, it's not a randomized study. It's not -- that would be the next study we get. But there's a very well-catalog information on pancreatic cancer and what OS is.

So we think we -- we will get a handle on that and be able to say, OK, we have, you know, ORR, we have duration, and we have some trends in -- in OS because it's not going to be statistically meaningful to our data. That would happen next. But we have trends there. And we saw these kind of things in other drugs we developed and it's important to look at them and say, how are you doing in all these really critical datasets? And that's what we've been doing.

And I have gone on record saying I am, you know, really interested in this and excited about what we're seeing initially. To that extent, we -- we -- we publicly said we're going to expand what we're doing. We -- pancreatic cancer, a lot of people in history have seen data on a little bit, a few patients and have been -- and once you go to a lot of patients, it hasn't really panned out. So we're trying to be appropriately studying this to know, you know, in a expanded population from our initial, you know, evaluation, will the data hold will be exciting and should we go into a pivotal trial with it? And this is something -- it's the way we develop many drugs.

And so this is not unique to S40. This is something we've done with other drugs and expanded what we've done and get a really good handle. And I think that by doing these expansion studies of single-arm studies, your hit rate of phase 3 is in randomized studies is much higher. And I think that our hit rate historically has been high once we get some additional conviction based on a little bit bigger study and not just a tiny study.

So that's what we did with this. We had a very small amount of data. We were, you know, I was -- speaking for myself, I was excited with it. But I and the clinical team here wanted to really be sure of what we're seeing.

So that's what the data that will come out is. Roger, do you want to have any comments on this?

Roger Dansey -- Chief Medical Officer

I think too. So these are single-arm experiments, and obviously, the key points are executives who say what's the rate of response? What's the durability of those responders? What is progression-free surviving look like? And what is overall survival look like? And there is a very clear record of what, you know, what to expect with the standard chemotherapy. So hopefully, if we see positive data, we'll -- we'll be able to make some decisions about what a potential next step would be.

Kennen MacKay -- RBC Capital Markets -- Analyst

Awesome. Thank you guys so much. That's -- that's very, very helpful and does sound like somebody excited about.

Operator

The next question comes from Gena Wang from Barclays. Please go ahead.

Sheldon Chuan -- Barclays -- Analyst

Hi, this Sheldon on for Gena. Thanks for taking all the question. Maybe just one quick question about the Tukysa launch in Europe. We're glad to hear that you had launched in Germany, France, and Austria.

So what do you see the potential ramp up there over the course of next like a year? How many additional markets would you expect to enter? And also in a related question on Padcev Europe -- potential European launch. So do you expect the launch pace to be roughly the same?

Clay Siegall -- President and Chief Executive Officer

So first of all, thank you about the Tukysa question about Europe. We are very pleased with our progress. Tukysa's now approved in 36 country -- countries worldwide, and that includes EU and the U.K. We have general managers in the major countries and building teams.

They have deep industry experience. We have done commercial launches now as we've said in Germany and France within one month of EMA approval. So that's brand new. We are working to make Tukysa available as quickly as -- as possible and feasible in all the European countries.

But we have to navigate the local HCA processes. So that takes time. They don't all come on at once. I mean, this is, you know, a little bit of a different process than in the U.S.

where, you know, you could say that once the U.S. approves, all states are approved. But in Europe, you have to go one at a time, at a time. And we don't -- we don't just do them sequentially.

We're working on it at the same time. But it still is not all [Audio gap] And then with regard to the U.K., we are actively engaging with the organization called NICE with a decision expected in the fourth quarter of this year. So very, very big efforts to get it into all these countries. We've just a few of the countries recently having commercial launches.

And so right now, we expect the majority of Tukysa revenues to come from the U.S. And -- and that's where we are for now. But, you know, in the future, we expect more and more to come from Europe.

Operator

The next question comes from Stephen Willey from Stifel. Please go ahead.

Ellen Sands -- Stifel Financial Corp. -- Analyst

Hi, this Ellen on for Steve. So [Inaudible] tucatinib is being eval -- evaluated in combination with in HER2, in HER2CLIMB-04. So I'm just curious what the bar for successes there and maybe how you're thinking about the safety profile of this combination?

Clay Siegall -- President and Chief Executive Officer

Sure, absolutely. To repeat that, Tukysa is a great drug to combine with and use, you know, in a lot of different regimens. Roger, can you talk a little bit about what you're thinking with Tukysa in HER2?

Roger Dansey -- Chief Medical Officer

Yeah, so -- so both drugs were highly active. And obviously, combining active drugs in -- in oncology is a -- a potentially fruitful path in terms of trying to find effective combinations. And just bear in mind, because in HER2 it's trastuzumab plus chemotherapy, it's essentially the same sort of conceptual construct as was in HER2CLIMB where we combined tucatinib with trastuzumab and chemotherapy, which is capecitabine. So it's following the path frankly that we are taking with tucatinib in multiple other places.

We're using tucatinib in combination with Kadcyla. I don't think we've set any bars. We -- we need to explore. And we'll -- we'll see, you know, once we have some data to hand, we can determine what -- what potential value that regimen may have as a combination.

From a safety perspective, again, I don't think we have any expectations one way or the other. I don't think we're expecting amplification of safety from either side. But we need to generate the data and then we can evaluate.

Ellen Sands -- Stifel Financial Corp. -- Analyst

OK, great. Thanks for taking the question.

Operator

Next question is from Andy Hsieh from William Blair. Please go ahead.

Andy Hsieh -- William Blair & Company -- Analyst

Great. Thanks for taking my question. So I'm just wondering if you could elaborate on your strategic positioning for SGN-CD30C? Would that be kind of an improved product to the medical community or, you know, you would be exploring areas where you haven't or basically are not amenable to be targeted by -- by Adcetris?

Clay Siegall -- President and Chief Executive Officer

So I appreciate very much the question. We definitely have second-generation molecules that we're working for Adcetris. There's actually a few that we're working on. And one of them we call C as you refer to.

But there are some different molecules. Quite frankly, they're all exciting. It would not be impossible for us to take more than one to phase 1 study and compare them there and then decide which one to go with. So I don't want to rule that out either.

There are some technologies that I'm not at liberty right now to explain exactly. But, you know, I think are exciting. You know, I have a unique perspective. And having been one of the pioneers in the field and building it up and the fields now really taken on a life of its own and it's a lot of companies now work on ADCs.

So I -- I look in the past and some of the ADCs and how they were made were with bad linkers and natural product drugs and I call that 1.0. And then there was, you know, you know, better drugs, synthetic drugs, and much better linkers that are in drugs like Adcetris and Padcev and Polivy from Roche and -- and -- and others. And so I call that, you know, ADCs 2.0 if you will. And then how will we get as a field to ADCs 3.0 and what can we do? And what are the technologies that are needed to continue with improving the efficacy in patients and decreasing any of the side effects that you have? That's always the goal.

Or -- or what, you know, the docs say, you know, getting a better risk-benefit ratio? And how can we do that and what can we do? So we've spent many years pioneering some new technologies that we have. And I am really jazzed up about these new technologies based on all of their preclinical data and efficacy and in safety, including non-human primates. So I think what you'll see from us is another generation of new ADCs that, you know, may have different payloads, different linkers, different ways of thinking about how to do these, different toxicities, or lack thereof. And those are coming.

So we -- we are -- we are working hard on ADC 3.0, so stay tuned. We'll be talking about it as soon as it's appropriate to.

Operator

The next question comes from Jay Olson from Oppenheimer. Please go ahead.

Jay Olson -- Oppenheimer & Co. Inc. -- Analyst

Hey, thanks for taking the questions, and congratulations on all the progress. Since you have an October PDUFA for TV, can you talk about some of the work that you've done to prepare for the launch, including anything on reimbursement or treatment guidelines? And then separately, as you look across your broad product portfolio and pipeline, do you see any gaps that you want to prioritize for business development purposes? Thank you.

Clay Siegall -- President and Chief Executive Officer

OK. So the first question is on TV and launch and reimbursement and all the rest. You know, we certainly have submitted and we're certainly working with regulators on this. We have a PDUFA date.

We're working on combinations with Keytruda and with chemotherapy. We've talked about that already in the call. So there's a lot going on that, you know, we'll -- we'll work on, and you know, and we'll continue to work on before -- and in front of our PDUFA date of October 10. And -- but, you know, we're really excited that this could be our fourth drug.

And we think it's something we understand. We know how it'll help patients. The confirmatory study is continuing, and we have planned enrollment in the U.S. and abroad.

And, you know, certainly, when you look at the commercial planning, we will go ahead and -- and make sure that this gets launched really well. We're working with our partner, Genmab, on this. Chip, do you want to have a brief comment? I don't want to say too much about this. It's a little early and it's, you know, it's also ba -- I don't think we want to outline too much yet.

We're, you know, just got only a few weeks ago, we got accelerated status for approval, so I don't want to get, you know, ahead of where we are. But, Chip, can you give some general comments?

Chip Romp -- Executive Vice President, Commercial U.S.

Yeah, sure, Clay, absolutely. So we -- we've got -- have key personnel in the commercial organization in place. They've been in place for some time now and have been working to make sure that we're launch ready by the time of the PDUFA date. Like Clay mentioned, we're looking forward to co-promoting this with Genmab.

We will also pull in some of the best practices that we've had in the Padcev and Tukysa launches.

Operator

The next question comes from Reni Benjamin from JMP Securities. Please go ahead.

Reni Benjamin -- JMP Securities -- Analyst

Hey, good afternoon, guys. Thanks for taking the questions. I guess mine is regarding the non-muscle-invasive opportunity. Can you maybe provide some color regarding the discussions with the regulatory agency and the trials planned for BCG-unresponsive patients? But do you have any thoughts on -- on moving that, you know, either in combination or potentially supplanting on BCG?

Clay Siegall -- President and Chief Executive Officer

Sure. Thanks, Reni, for the question. Roger, do you want to address what we can talk about now?

Roger Dansey -- Chief Medical Officer

Sure. So, you know, non-muscle-invasive bladder cancer is a -- is a large, you know, a large unmet need. As you point out, BCG-unresponsive is the place to begin. But depending upon what the product's profile looks like in terms of its efficacy and safety, it -- there's always a possibility to consider combinations, and a lot of folks are going with combinations of BCG or potentially looking for, you know, a-- a new gold standard.

What's attractive about Padcev in terms of its possibility, and it is just at this point of possibility, is that in the preclinical experiments that we've done, we have almost no systemic exposure. And that's an important part of the equation for patients who, you know, are not going to die necessarily of bladder cancer that needed to be managed and try potentially to avoid things like surgery. That's the one point. The other is that the target that Padcev is going after, which is Nectin-4, is highly expressed not only in the advanced and metastatic populations and in muscle-invasive but in non-muscle-invasive as well.

So we have an opportunity to instill Padcev test, you know, giving intravesical Padcev to see if we can gain control first of BCG-unresponsive. And then if we have a strong -- if we have a strong positive benefit risk that we would like to take forward, yes, we would clearly want to develop it further it.

Reni Benjamin -- JMP Securities -- Analyst

OK. Thank you.

Operator

The next question comes from Zhiqiang Shu from Berenberg. Please go ahead.

Zhiqiang Shu -- Berenberg Bank -- Analyst

Hi, thanks for taking my question. I have a quick one on -- on your CD40 antibody. Maybe can you talk about the biology on that target that why -- why you think your sugar-engineered FCE antibody can work better than other antibodies? I think for you, it seems like the side effects could be the issue, I guess. Why do you think FCE has -- could -- could maybe avoid that problem? Thank you.

Clay Siegall -- President and Chief Executive Officer

So I'm not exactly positive how to address this. But, you know, what we're looking at is trying to enhance the activity that you get to effector function and also decreasing inhibition that you get. You know, when you look at PD-1, they release the brake on T-cells. So it's a very fine balance between getting more activity but releasing inhibition.

And we think that our SEA technology does have some properties that no one else has. And we've observed them in preclinical models and we've talked about them a lot. So we're really excited about it. Now, the proof is in the pudding.

We have to go and we have to test this in humans that have cancer and see what we obtained, both on safety, because we're very, very cautious about making sure we're safe in patients and -- and really transparent about that. But also in efficacy and seeing what happens. And in addition to working with this as a single link, there's a lot of efforts going on to bring it in in combination, and that's something with the PD-1 inhibitor, and that's something that's important as part of the -- the trials. So we -- we're -- we're bullish on the molecule, we're bullish on our technology, and we're hopeful.

But we're not ready to discuss or present the data.

Zhiqiang Shu -- Berenberg Bank -- Analyst

Thank you.

Operator

The next question comes from Brad Canino now from Credit Suisse. Please go ahead.

Brad Canino -- Credit Suisse -- Analyst

Thank you. I want to ask, is some of the moderation in the Padcev sales growth over the past few quarters due to patients being too sick to continue to a third-line therapy and not getting the opportunity to try Padcev? And then more broadly, Clay, how do you think about the low systemic treatment penetration in metastatic bladder cancer overall? And then maybe how Padcev can change that when it gets approved in earlier lines?

Clay Siegall -- President and Chief Executive Officer

OK. So these are the questions I -- I certainly want Chip to -- to comment on. Chip, would you -- do you want to see what -- would you -- how you can answer this?

Chip Romp -- Executive Vice President, Commercial U.S.

Yeah, absolutely. So it's not uncommon at this stage of a launch to see product growth begin to decelerate. Padcev is a standard of care. We are very optimistic about the changing market dynamics in -- in this marketplace.

PD-1s and PD(L)-1s have moved up utilization into the frontline. We think that's going to continue in 2021, which would buy Padcev an opportunity to increase its treatable patient population.

Operator

There are no more questions in the queue. This concludes our question-and-answer session. I'd like to turn the conference back over Peggy Pinkston for any closing remarks.

Peggy Pinkston -- Senior Vice President of Investor Relations

OK. Thank you, operator, and thanks, everybody, for joining us this afternoon. Have a great evening.

Operator

[Operator signoff]

Duration: 61 minutes

Call participants:

Peggy Pinkston -- Senior Vice President of Investor Relations

Clay Siegall -- President and Chief Executive Officer

Chip Romp -- Executive Vice President, Commercial U.S.

Todd Simpson -- Chief Financial Officer

Roger Dansey -- Chief Medical Officer

Greg Harrison -- Bank of America Merrill Lynch -- Analyst

Connor Meehan -- Morgan Stanley -- Analyst

Salveen Richter -- Goldman Sachs -- Analyst

Turner Kufe -- J.P. Morgan -- Analyst

Michael Schmidt -- Guggenheim Partners -- Analyst

Andrew Berens -- SVB Leerink -- Analyst

Kennen MacKay -- RBC Capital Markets -- Analyst

Sheldon Chuan -- Barclays -- Analyst

Ellen Sands -- Stifel Financial Corp. -- Analyst

Andy Hsieh -- William Blair & Company -- Analyst

Jay Olson -- Oppenheimer & Co. Inc. -- Analyst

Reni Benjamin -- JMP Securities -- Analyst

Zhiqiang Shu -- Berenberg Bank -- Analyst

Brad Canino -- Credit Suisse -- Analyst

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