Seagen Inc

F:SGT

Earnings Call Transcript 2020-Q3

[Operator]

Good day, and welcome to the Seagen Third Quarter 2020 Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions] Please note this event is being recorded. I would like to turn the conference over to Ms. Peggy Pinkston, Vice President of Investor Relations. Please go ahead.

[Peggy Pinkston, Vice President-Investor Relations]

Thank you, operator, and good afternoon, everyone. I'd like to welcome all of you to Seagen’s third quarter 2020 financial results conference call. With me today are 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.

Accompanying today's conference call are supporting slides, which you'll find on our website in the Investors section, Events and Presentations page. Following our prepared remarks, we'll open the line for questions. We aim to keep this call to one hour and so ask that you limit yourself to one question to give everyone an opportunity to participate in Q&A during our call today.

Today's conference call will include forward-looking statements regarding future or anticipated events and results, including the company's 2020 financial outlook, anticipated product sales, revenues, costs and expenses and potential clinical and regulatory milestones, including data readouts, regulatory submissions and approvals. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the difficulty in forecasting sales, revenues and expenses, impacts related to the COVID-19 pandemic and the uncertainty associated with the pharmaceutical development and regulatory approval process. More information about the risks and uncertainties faced by Seagen is contained under the caption Risk Factors included in the company's periodic reports filed with the Securities and Exchange Commission, including the company's quarterly report on Form 10-Q for the quarter ended June 30, 2020.

And now I'll turn the call over to Clay.

[Clay Siegall, President and Chief Executive Officer]

Thank you, Peg, and good afternoon, everyone. We continue to make extraordinary progress and I look forward to sharing some of the specifics on our call today. I want to start with a few comments about our recent corporate name change from Seattle Genetics to Seagen. This new name reflects the evolution of our company, especially over the past year and our expanding global operations. We have brought important new medicines to the market and we're working to bring our three approved drugs to more patients through geographic expansion and new indications.

At the same time, we continue to advance our pipeline of innovative therapies for solid tumors and hematological malignancies. Our footprint has expanded beyond the Pacific Northwest with Seagen offices in San Francisco, Canada, Switzerland, and across Europe. The company has built strong global partnerships with Takeda Astellas, Genmab, and Merck. At Seagen, we remain committed to delivering innovative cancer medicines to patients around the world.

With that in mind, the third quarter was highlighted by several notable accomplishments. First, we reported revenues of $1.1 billion. This included record product sales of $267 million, collaboration revenues that included $725 million from the Merck agreements as well as growing royalties.

Second, we and our partner Astellas reported positive top-line results from the PADCEV Phase 3 EV-301 trial in patients with previously treated metastatic urothelial cancer. The trial was stopped early for efficacy at a pre-specified interim analysis. These data are particularly important as we intend to use the trial to support global registrations, as well as to convert PADCEV’s U.S. accelerated approval to regular approval in this setting.

Additionally, we reported positive results from Cohort 2 of our EV-201 trial, which could support a second U.S. label. Third, TUKYSA was approved in Australia. This followed approvals in the United States, Switzerland, Singapore, and Canada under the FDA's Project Orbis initiative all within the last six months.

Our marketing authorization application in European Union is currently under review by the EMA. And we are continuing to build our international infrastructure and capabilities to support TUKYSA launch in Europe. We entered into two strategically important collaborations with Merck, covering with Ladiratuzumab Vedotin or LV and TUKYSA.

First, we and Merck will co-develop and co-commercialize LV, our antibody drug conjugate in development for breast cancer and other solid tumors. We believe this collaboration will allow us to accelerate and broaden the clinical development of LV, including combination with Merck's KEYTRUDA. In addition, the agreement included upfront and progress dependent milestone payments and Merck acquired a $1 billion equity stake in Seagen that closed this week.

Second, we granted Merck an exclusive license to commercialize TUKYSA in Asia, Latin America, and the Middle East. TUKYSA collaboration will help us reach more patients globally and benefit from the established commercial strength of one of the world's premier pharmaceutical companies. Including the stock sale, the total potential value of these two deals is approximately $4.5 billion plus royalties or net sales of TUKYSA and global profit sharing for LV.

Importantly, Seagen will lead commercial activities for both drugs in the U.S., Canada, and Europe. Lastly, in the third quarter, we and our partner, Genmab presented positive results at ESMO from the pivotal innovaTV 204 trial in women with recurrent or metastatic cervical cancer. Together, we plan to submit a biologics license application to FDA under the accelerated approval pathway, which would position TV as our fourth commercial product.

In addition, we and Genmab recently amended specifics of the TV global commercialization plan, whereby Seagen will lead global commercial activities, except in Japan. We will continue joint decision-making on worldwide strategy and Seagen and Genmab will co-promote TV in the U.S. In addition, Seagen will lead the majority of global operational development activities.

I'm pleased with the progress across our programs, even in this time of a global pandemic. Chip will discuss later in the call, the refinements that we're making to our ADCETRIS sales guidance, and Todd will provide a few updates on guidance and our financial position following completion of the Merck deals. As we look ahead, in addition to continuing to deliver commercially, our strategy is centered on three key priorities, investing in clinical development to maximize the potential of ADCETRIS, PADCEV, and TUKYSA.

Advances our late-stage pipeline, including TV and LV toward gaining approvals for additional commercial products and conducting innovative research and development to ensure a robust early stage pipeline of novel therapies, including ADCs and immunotherapy agents. We plan to discuss our significant efforts across these key areas in more details during our upcoming virtual R&D day taking place on November 16.

Finally, I wanted to provide an update on our legal disputes with Daiichi Sankyo. Last week, we filed a complaint against Daiichi Sankyo for infringement of a newly issued Seagen patent covering the breast cancer drug and HER2. This action is separate from the ongoing arbitration over the disputed ownership of certain technology used in HER2 and other product candidates emanating from our 2008 agreements. We intend to vigorously pursuit both legal actions.

Seagen has become a multi-product, global oncology company and is making significant progress across our programs with substantial financial resources along with growing product sales, we are well-positioned to continue building Seagen to address the needs of cancer patients.

Next, I'll turn the call over to Chip to discuss our commercial activities. Then Todd will comment on our financial results and guidance. After that Roger will discuss our clinical development activities. Chip?

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

Thanks, Clay. The commercial team built upon the strong momentum established in the first half of the year and delivered solid results in Q3. We continue to execute our remote work strategies. Our enhanced digital marketing focus continues to produce strong interests and engagement with our target customers. I'll start today with ADCETRIS. We reported third quarter sales of $163 million, a decrease of 3% from the third quarter of 2019. We believe the pandemic is impacting ADCETRIS sales. Recent claims data and electronic medical records data indicate that new HL diagnosis trends are approximately 15% lower than historic levels.

Postponed doctor visits during COVID may lead to delays in new diagnosis, which is concerning as this can lead to patients having more advanced stage of disease when first diagnosed. Additionally, a site of care shift negatively affected gross to net pricing this quarter. However, despite this, we are encouraged that ADCETRIS has maintained market share in its frontline indications.

As a result of this, we are refining our 2020 ADCETRIS guidance to a range of $650 million to $660 million. Looking ahead, recent market research suggests that the five-year follow-up data from the ECHELON-1 trial in frontline Hodgkin's lymphoma will be of strong interest to prescribing physicians. Five-year followup data is an established standard, and we expect that doctors will appreciate the durable advantage of ADCETRIS. We look forward to promoting these data after ASH.

Moving on to PADCEV. We are pleased with our third quarter sales of $62 million and increases 8% over the second quarter of this year. Year-to-date PADCEV sales were $153 million showing rapid adoption of the product, gives a strong in both academic and community accounts and the breadth of ordering was robust. We remain focused on growing market share in our labeled indication.

And finally, our latest product TUKYSA. In the first full quarter of sales since launch, net product revenues were $42 million. We attribute the continued strong adoption of TUKYSA to favorable guidelines placements, and rapid inclusion in treatment pathways and strong KOL and patient advocacy. Patients with and without brain metastases are being prescribed TUKYSA. And the number of new accounts ordering was robust for the quarter. Reimbursement coverage for TUKYSA has exceeded our expectations. And I would like to thank our team that worked so hard to ensure patients have access to this important medicine.

And with that, I'd like to turn the call over to Todd.

[Todd Simpson, Chief Financial Officer]

Thanks, Chip. And thank you everyone for joining us on the call this afternoon. Today, I'll summarize our financial results for the third quarter and year-to-date. I will also comment on the significant financial impact of the new deals with Merck and then discuss our outlook for the remainder of 2020. Total revenues were $1.1 billion in the third quarter, and $1.6 billion for the year-to-date in 2020. In addition to product sales of $267 million for the third quarter and $706 million for the year-to-date that Chip summarized.

Royalty revenues were $36 million in the third quarter and $88 million for the year-to-date in 2020. Growth over 2019, primarily reflects sales of ADCETRIS by Takeda, and to a lesser degree royalties on sales of Polivy by Roche. Collaboration revenues were $758 million in the third quarter and $780 million for the year-to-date in 2020. This compares to $18 million and $99 million respectively for the same periods in 2019. The considerable increase in collaboration revenues in 2020 reflect $725 million in upfront payments received from Merck under our recent LV and TUKYSA deals.

Cost of sales increased to $78 million in the third quarter of 2020 and to $156 million for the first nine months of the year. This includes product costs of sales for each of our three brands and PADCEV’s profit share to Astellas, which was $29 million in the third quarter and $73 million for the year-to-date. In addition, cost of sales includes non-cash amortization of acquired technology costs of $6 million per quarter. That began with the launch of TUKYSA in April and a sub-license payment that is owed related to the TUKYSA license agreement with Merck in Q3.

R&D expenses were $218 million in the third quarter and $611 million for the year-to-date in 2020. These are plant increases over 2019 and primarily reflect increased investment across our pipeline. SG&A expenses were $128 million in the third quarter and $375 billion for the first nine months of the year in 2020. These are increases over 2019 and reflect U.S. commercialization of PADCEV, TUKYSA and our European expansion as we prepare for the TUKYSA launch beginning next year. I want to briefly comment on the profit reported in the third quarter and for the year. This is the result of recognizing upfront payments totaling $725 billion for Merck in the quarter as collaboration revenue.

From a tax perspective, we utilize federal net operating loss, carry forwards has allowed. However, we incurred some state income taxes in states where we did not have available deferred tax assets. While these revenues led to a profit for the quarter, our longer-term growth strategy remains to continue to invest in seeking further labels for our commercial drugs and in our pipeline to enable new medicines that can help patients’ need. We are in a very strong financial position. We ended the third quarter with $1.7 billion in cash and investments. This includes $725 million in upfront payments received from Merck under the LV and TUKYSA deals and $85 million in prepaid TUKYSA development expenses.

As part of the LV collaboration, Merck has also made $1 billion common stock investment in Seagen that closed earlier this week, following HSR clearance. The stock purchase will be reflected in our year end financials.

I'll now turn to our financial outlook for the remainder of 2020. We are reducing our ADCETRIS guidance to a range of $650 million to $660 million. As Chip described, this reflects fewer new patient diagnoses, which we believe is due to effects of the COVID-19 pandemic and a site of care shift that negatively affected our gross to net margin. We are increasing our 2020 guidance for royalty revenues to a range of $125 million to $130 million. This reflects sales of ADCETRIS by Takeda in this territory and contributions from royalties we receive from Roche for Polivy and from GSK for Blenrep.

As a result of the new agreements with Merck, 2020 collaboration net revenues are now expected to be in a range of $1.03 billion to $1.04 billion. This reflects two Merck related items. First, the upfront payments totaling $725 billion received and reported in the third quarter, and second, a $250 million stock purchase premium that will be recorded in the fourth quarter related to Merck's acquisition of $1 billion in our common stock as part of the LV agreement. This premium reflects the difference between the $200 price per share paid by Merck and our stock price in September when the deals were signed that was approximately $150 per share.

Lastly, we are updating cost of sales guidance to a range of $205 million to $225 million. This primarily reflects the sub-license fee that I mentioned was recorded in the third quarter as a result of the TUKYSA licensed to Merck.

Going forward, we will begin to reflect the funding received from Merck to support LV into TUKYSA development, which will reduce our R&D expenses. While the collaborations are now up and running, the impact of cost sharing is modest this year. That will be reflected in our guidance for next year. The remainder of our 2020 guidance is unchanged.

And with that, I'll turn the call now over to Roger.

[Roger Dansey, Chief Medical Officer]

Thanks, Todd, and good afternoon, everyone. Today, I will provide an update on recent progress and key upcoming development activities for our approved products, PADCEV, TUKYSA and ADCETRIS, as well as Tisotumab Vedotin and Ladiratuzumab Vedotin. I'll start with PADCEV, which we are developing in collaboration with Astellas. As Clay mentioned, we recently reported positive top-line results from two clinical trials in the metastatic setting.

First, we reported that single agent PADCEV significantly improved overall survival in the randomized Phase 3 EV-301 trial in patients with previously treated metastatic urothelial cancer. The hazard ratio was 0.7 with a P value of 0.001. In addition, PADCEV improved progression-free survival with a hazard ratio of 0.61 and the p-value of less than 0.00001. We and Astellas are working closely together on regulatory activities around the world, including submitting the data to FDA as the confirmatory trial for our current accelerated approval.

Second, top-line data were released from Cohort 2 of the EV-201 trial in patients who received a PD-1 or PD-L1 inhibitor, and were not eligible for treatment with cisplatin for metastatic urothelial cancer. The results showed a 52% objective response rates with 10.9 months median duration of response. The safety profile was consistent with the safety providers in the U.S. prescribing information. These patients have a high unmet need as they are older and suffer from multiple co-morbidities, including poor kidney function. And we believe that data from Cohort two could support a supplemental BLA to provide them with a new treatment option.

We look forward to sharing results of these two trials at an upcoming medical meeting. Another key component of our development program is moving PADCEV into first-line metastatic urothelial cancer for which we have a two-pronged approach. First, we are enrolling 150 patients randomized to receive either PADCEV plus KEYTRUDA or PADCEV alone in cohort K of the EV-103 trial.

This represents a potential U.S. accelerated approval opportunity in cisplatin-ineligible patients. Second, we are enrolling 760 patients in the randomized Phase 3 EV-302 trial, evaluating PADCEV plus KEYTRUDA compared to a platinum containing chemotherapy regimen, including cisplatin eligible patients. EV-302 is intended to support global registration and also serves as a potential confirmatory trial in the United States.

We are also exploring earliest stages of bladder cancer, including muscle-invasive disease. In cisplatin-ineligible patients, PADCEV has been incorporated into Merck's ongoing randomized Phase 3 KEYNOTE-905 trial. In collaboration with Astellas and Merck, we recently entered into an additional clinical trial agreements to evaluate PADCEV in another Phase 3 trial this time for cisplatin-eligible patients with muscle invasive bladder cancer. The details of which will be available soon. Collaborating with Merck on these two trials, significantly accelerate the development of PADCEV in this area of unmet medical needs.

I'll now move on to TUKYSA where we are making good progress on expanding the development program. In breast cancer, we are enrolling the randomized HER2CLIMB-02 trial in first and second line HER2 two positive metastatic disease. And in adjuvant breast cancer, we are supporting U.S. cooperative group that is conducting the randomized CompassHER2 RD trial. In colorectal cancer, the MOUNTAINEER trial is evaluating TUKYSA in combination with trastuzumab in third-line patients with HER2-positive metastatic disease. This is intended to support a potential accelerated approval.

In gastroesophageal cancer, the MOUNTAINEER-02 trial is evaluating TUKYSA in combination with trastuzumab, ramucirumab and paclitaxel in a Phase 2/3 study in previously treated second line HER2 positive metastatic patients. Phase 3 portion of the study is designed to support potential global approvals. More broadly, we are evaluated TUKYSA in combination with chemotherapy and trastuzumab in first-line GI malignancies, as well as in cancers with HER2 alterations. And we will describe these further at our R&D Day. Importantly at the San Antonio Breast Cancer Society meeting in December multiple [indiscernible] abstracts have been accepted for presentation, including additional analysis from the HER2CLIMB trial that supported its approval earlier this year.

Turning now to ADCETRIS, we continue to advance a clinical development program evaluating ADCETRIS lymphoid malignancies to support potential label expansions or informed clinical practice. We are also planning to evaluate ADCETRIS as an immunomodulatory agent in certain clinical settings, which we will share at our upcoming R&D Day. At the American Society of Hematology Annual Meeting in December we'll present five-year follow-up data from the ECHELON 1 trial in frontline advanced Hodgkin lymphoma.

These data are key as they represent an important clinical milestone reinforcing the positive long-term benefit of the approved ADCETRIS plus chemotherapy regimen in newly diagnosed stage three and four patients.

I'll move on now to Tisotumab Vedotin, our late-stage ADC targeting tissue factor available therapies for previously treated metastatic cervical cancer generally resulting low response rates. And overall survival is measured in months, underscoring the high unmet need in the setting. At the ESMO meeting in September we and our partner Genmab presented results in an oral late-breaking session from the innovaTV 204 trial that evaluated TV monotherapy in women with previously treated recurrent or metastatic cervical cancer.

The data showed a 24% objective response rates with an 8.3 months, median duration of response. Notably 79% of patients had a reduction in target lesions and responses were generally consistent across subgroups. The most common treatment related adverse events included alopecia, epistaxis, nausea, conjunctivitis, fatigue, and dry eye. We and Genmab plan to submit the BLA to the FDA to support accelerated approval in this indication and to initiate a randomized confirmative trial of TV and cervical cancer in the coming months. We are also advancing clinical trials of TV monotherapy in other cancers and in combination with other agents.

Lastly, we are pleased to be collaborating with Merck on the development of LV, given our productive relationship on PADCEV and our shared vision of improving the lives of people with cancer, I'm confident that the partnership will allow us to accelerate the evaluation of LV as a monotherapy and as a combination therapy with KEYTRUDA. Our current development program encompasses trials in triple negative and hormone receptor positive breast cancer, as well as a basket trial in other LIV-1 expressing solid tumors, including lung, head and neck, prostate, esophageal, gastroesophogeal and melanoma.

In closing, we are preparing for important presentations at medical meetings in the remainder of 2020, while also working diligently to advance our clinical trials and several regulatory applications globally. We look forward to sharing more details about our development activities, including our early-stage pipeline and innovative technologies at the upcoming R&D Day.

Now, I'll turn the call back over to Clay.

[Clay Siegall, President and Chief Executive Officer]

Thank you, Roger. Before we open the line for your questions, I'd like to recap some of our key upcoming events. First, report five-year follow up data from the ADCETRIS E1 trial in frontline Hodgkin lymphoma at the ASH Annual meeting and advanced multiple clinical trials. Second, continue to establish PADCEV as standard of care in advanced metastatic urothelial cancer submit applications to extend its use in the U.S. and seek approvals globally and advanced the broad development program, including trials in first-line metastatic and muscle invasive bladder cancer.

Third, continue the successful U.S. launch of TUKYSA ,work with regulators on the pending submission in the European Union and advances robust clinical development program. Fourth, submit a BLA to FDA for accelerated approval of TV in cervical cancer and advanced its clinical development in cervical and other solid tumors. Fifth, continue implementing our recent collaboration with Merck, including the co-development of LV. And lastly host our R&D Day in mid-November.

Finally, I'd like to close by thanking our employees for their resilience and commitment to our mission, to bring therapies to patients. Despite these difficult times that impacted all of our personal and professional lives. I'm proud of our progress and collective commitment to the cancer patients we serve. At this point, we'll open the line for Q&A. Operator, please open the call for questions.

[Operator]

We will now begin the question-and-answer session. [Operator Instructions] The first question today comes from Michael Schmidt of Guggenheim. Please go ahead.

[Michael Schmidt, Guggenheim]

Hey, thanks for taking my questions. I had one on ADCETRIS. I was wondering if you could comment some more on market dynamics. The midpoint of the updated 2020 guidance seems to suggest the possibility of another sequential decline in sales. I was just wondering what you seeing there in terms of the diagnosis rates and I guess how you think about those dynamics longer term when we look towards 2021, and maybe if you could also comment on the new growth to net adjustment. Thanks so much.

[Clay Siegall, President and Chief Executive Officer]

Hi, Michael. So I'll talk about the market a little bit. Todd to talk a little bit about gross to net. So we'll start with some comments. Look, our product sales have done really well when you look, year-over-year we're up 60%. We're very pleased with all three products. I know you asked about ADCETRIS that we're really pleased with helping all these patients that we do and working very closely with doctors and our drugs are really, they're important drugs. But as I'm sure you have seen, and everyone has seen, there's multiple sources that talks about how cancer care is being affected by COVID, which is incredibly unfortunate for patients, as a company that really cares about cancer patients. What we don't want to see is something in the not too distant future, where you have a lot of late-stage cancer patients that are first coming in rather than a mixture of early and late-stage cancer patients.

So, we hope this current thing about where, the markets research showing, less patients starting during this pandemic does not continue. And the patients do come in to get their cancer therapy, which they so badly need. Now in the middle of this, we're very pleased that we have at least maintained and maybe even grown a little market share of the patients that are being treated. So we are definitely not losing market share. There's just less patients coming in and we can measure that. So we feel good about our market share, and we really wish patients would get their therapy so that they don't become really late stage when they first come in. So that's really what the dynamics are this going on with ADCETRIS. Todd, would you like to talk about gross to net?

[Todd Simpson, Chief Financial Officer]

Sure. Happy to, and thanks for the question. So I'll start off by saying most of this relates to PHS utilization. This is a sizable portion of the ADCETRIS book of business. In this setting, we offer discounts that are approximately 60%. So even, a fairly small change in mix of business has an impact on gross to net. We've seen this variability in the past and we saw it in Q3. It's a little though hard to pinpoint exactly what's driving it, but we did want to call it out as one of the factors in the quarter.

[Michael Schmidt, Guggenheim]

Great. Thanks for clarifying that. And congrats on all the good pipeline this quarter.

[Operator]

The next question comes from Cory Kasimov of JPMorgan. Please go ahead.

[Cory Kasimov, JPMorgan]

Hey, good afternoon guys. Thanks for taking my question. Wanted to ask about PADCEV and the relative slowdown in sequential growth that we saw this quarter. I guess, looking at that, does it change your view as to whether there was a bolus or a warehouse effect in earlier quarters? Are there other factors that play that where the sequential growth dropped to single digits 2Q to 3Q. Thanks a lot.

[Clay Siegall, President and Chief Executive Officer]

Cory, thanks for the question. PADCEV launch has been very strong. We had a rapid uptick, and a strong uptick, ahead of where – you and the other analysts had thought we'd be for a couple of quarters now. And the rapid integration of PADCEV by oncologist, it's your standard of care for on-label use patients. That’s been great. It is not unusual at all. At this stage of a successful launch to see a little bit of slowing of growth as you get a strong market penetration, but I can assure you that feedback from the healthcare professionals has been very positive. The use has been both community and academic settings, we're maintaining our guidance and we really look ahead for big things with PADCEV that we are certainly working hard at several label expansion opportunities.

We just had our positive 201 and 301, we're looking forward to 201, 301 data, but data we've put out very positive cohort 2, 301. We have a big development program with in frontline with metastatic urothelial cancer, as well as muscle invasive bladder cancer. So there's just a lot going on with PADCEV. But certainly once again, the cancer care is being affected by the COVID pandemic. And it has created some barriers for customers. There a lot of the customers with PADCEV are older and a lot of the older people that unfortunately then diagnosed with bladder cancer, many are going in and getting therapy as you could see from our sales, but not every one is going. So I don't think it's the – what you said is the warehousing or any of that stuff. We don't [indiscernible] we see. Chip, would you like to give a little color on what we're seeing?

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

Yes, absolutely. Clay, thanks. We'd comment the total number of ordering a council was up in Q3. I think there's some additional opportunity left in our label, obviously. And we're gaining traction with regard to our virtual outreach efforts. And as far as face-to-face interactions with our sales teams, they're increasing month-to-month.

[Cory Kasimov, JPMorgan]

Okay, thank you guys, I appreciate it.

[Operator]

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

[Kennen MacKay, RBC Capital Markets]

Hi, thanks for taking the question. Two questions, one quick one PADCEV, wondering if you are getting a sense of what the duration of use is currently in sort of the real world setting and physicians are discontinuing either due to progressing or adverse events. And also on PADCEV I’m wondering if you’re seeing any off-label use, especially in combination with KEYTRUDA?

And then just separately was hoping you could give us a little bit of detail on some of the regulatory interactions you had around TV. It seems like the [indiscernible] maybe a little bit higher and a little bit more upbeat with the regulatory plans, a little bit more solidified here. Thank you.

[Clay Siegall, President and Chief Executive Officer]

Okay, very effective use of one question to ask for three. So I compliment you on that.

[Kennen MacKay, RBC Capital Markets]

Sorry.

[Clay Siegall, President and Chief Executive Officer]

No, it's okay. So, when you think about PADCEV and duration, our first trial that we got approval on, we have our label on, had somewhere between five and six months of treatment. And so it was or five or six cycles, I should say. That's what we have approved. Now, if you saw our EV-201 data, which is Cohort 2, which is the – is really second line, third line that came out, that we don't have approval for yet. That was a – duration in that trial was over 10 months, it was about 10.5 months. So it could be different as you go up and as we see things in the future.

So that's why we reported a pivotal trial. We're not at this point reporting on duration of use. Certainly those data certainly lag as we assess, and we watch them and we see what happens six months of follow-up. And as we move into earlier lines of treatment, like I said, with Cohort 2 there has been change. So we will see how that goes.

I mean off-label use and combination with Keytruda, our data are really good there. But that's not something that we don't promote to. And I don't think we hear a lot about it because there's a lot of different trials that we have now. And we hope that most patients are going on trials that we have with the combination.

And the third thing is on the regulatory interactions and TV, it’s inappropriate for us to give you specifics on that at this point. Sufficed to say that we have a lot of efforts going on with TV right now and looking to – we're working with our partner, Genmab on this, we're trying to get all our I's dotted and T's crossed and see if we could get a great package to regulators. But the specifics of the interactions are something that we do not want to discuss that because, I think, that is confidential with FDA.

[Kennen MacKay, RBC Capital Markets]

Thank you.

[Operator]

Thank you. Next question comes from Salveen Richter of Goldman Sachs. Please go ahead.

[Salveen Richter, Goldman Sachs]

Good afternoon. Can you provide color on the TUKYSA launch? How the drug is being used in the treatment paradigm if there have been any hurdles to adoption here? And what data we should expect from HER2CLIMB trial at San Antonio?

[Clay Siegall, President and Chief Executive Officer]

Right. So we are very excited about TUKYSA. I mean, this is a really great drug. We feel that we have a – it's very early in its launch, but we're really pleased with the progress and the access that we've had with healthcare professionals has been really good despite the challenging time with COVID-19. The level of awareness of this drug and uptake in both community and academic settings has been great. Data has been – our data that supports TUKYSA in both patients with brain mets and with visceral disease with operating mets, doctor using it for both types of patients. And our activity with OS and PFS is really it's great. And our data with brain mets, is really unprecedented. So that's important.

Maybe Roger, you could make some – maybe some other comments on Salveen’s questions.

[Roger Dansey, Chief Medical Officer]

So thanks Clay. So as you know HER2CLIMB was presented at San Antonio last year, and we presented the follow-up data focusing on brain mets at ASCO. And in fact, we continue to present data at ESMO and some other meetings. And the reason for this is because HER2CLIMB is a very rich trial. It was designed, has an elegant design, great execution and there's a lots of information that that trial continues to provide in order to inform people about the value of Tucatinib in that circumstance.

So without getting into any specifics, we'll continue to present more data from HER2CLIMB at San Antonio with the purpose of informing folks about Tucatinib’s value in various groups and so on.

[Salveen Richter, Goldman Sachs]

Thank you.

[Operator]

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

[Unidentified Analyst]

Hi, all thanks for taking the question. This is Connor [ph] on from Matthew. So just another question on ADCETRIS demand dynamics. You guys mentioned that the diagnosis rate is down, I guess, from baseline. And so we are just wondering additionally beyond that is it possible that the change in sales is partially due to conversion slowing to the first line and maybe the aggregate share is flat from the beginning of the year, or are there any other dynamics you are seeing there?

And then I guess, do you see the five-year data while physicians may be excited about that, do you see that as potentially, materially affecting uptake?

And then just quickly on the R&D Day, can you just walk us through what we should expect out of that data for the data presented at the R&D Day? Thank you.

[Clay Siegall, President and Chief Executive Officer]

Okay. Once again, with very – congratulations Connor [ph] on sneaking in a lot of questions here. So like I said, with ADCETRIS, and Chip can certainly chime in a moment. We don't believe that this is anything more than really just patients not coming in to get cancer therapy during this pandemic. And so if it wasn't for the pandemic, I certainly believe that we would have been within our guidance and strong. And so our baseline of patients that are getting diagnosis and coming in is smaller, and that's really the issue. And companies are reporting this all across the Board with all sorts of cancers. This is not unusual to Hodgkin lymphoma T lymphoma, this is not unusual to CGM, this is pretty standard.

In fact, I'm almost pleased that we haven't lost much of a percentage. The amount of percentage that we've lost on a real scale is small compared to that. We would show you, how important are drugs are. And patients still getting a lot of our drugs and all of them. And so we are not worried about this. I'm more worried, quite frankly, as a cancer biologist, I'm worried about patients who are not doing well with cancer. And so that's something that I really am worried about at some point. And I just don't want to make too much out of losing a small percentage of sales based on the pandemic. And so that's something that where we think.

Now you asked about the five-year data and that's something for ASH, we're excited to do that. Five-year data in lymphoma is – standard of care, the gold standard. And that’s what the doc call want to see because in Hodgkin lymphoma, it is unlike most cancers, it has a percentage of patients at high percentage that are cured. And cured is a definition that the HemOnc use, as you have known your disease free survival for five years, and you have no evidence of disease. Anybody with cancer, who knows when they're told they have cancer and then five years later, you are told you have no cancer go live your life, isn't great day.

And that's when doc say you are cured by that definition. And so everyone wants to hear that, that has ever been diagnosed with cancer. So we believe our five-year data is important. And docs have been asking for it. And that's something that we look forward to discussing. And then we can say, here's the difference in cure rates. And actually have cure by that definition and look at the whole dataset, which includes safety and other things.

So, we're excited. I mean, why would anybody want to get bleomycin and all the lung scarring and lung toxicity associated with that, is something that we're trying to get away from. And I think our five-year data will go toward that.

As far as R&D Day, we have an outline of specifics of what you're going to hear and all the data. But we're going to cover if I was going to say three things, we're going to cover an R&D Day, our existing products and how we're expanding them and their use, our late-stage products and the excitement with those. And then earlier stage products using all sorts of our innovations to really guide you a little bit. We're not going to cover every single one of our early stage programs, because we're not going to be on our virtual R&D Day feel all day long. But we're going to pick some highlights of some of the programs. And we're really jazzed up about doing the R&D Day.

[Unidentified Analyst]

Great, thank you.

[Operator]

The next question comes from Geoff Meacham of Bank of America. Please go ahead.

[Greg Harrison, Bank of America]

This is Greg Harrison, on for Geoff. Thanks for taking our question. So how does the cash in flux from Merck affect your capital allocation strategy, with respect to business development, M&A, or internal R&D? I know you had previously said it wasn't earmarked for any specific purpose, but just wondering if you had an updated view and if you had used it to take advantage of any opportunities you're seeing in this environment?

[Clay Siegall, President and Chief Executive Officer]

Yes, I think Todd can address this. What I will say is that we're just delighted to be working with Merck. They are just such a fantastic organization. And while Seagen has grown and really done a lot of working on three drugs approved and we'll have more approved in the future and I'm looking forward to that, we still can learn a lot from a company as successful, and powerful, and global as Merck. So I'm really excited with the whole deal that we've done with the – two deals. Todd, would you like to address the question?

[Todd Simpson, Chief Financial Officer]

Sure. Thanks for the question. So I guess when it comes to capital allocation well I won't give specific percentages. What I can speak to is what we're focused on. And probably the number one priority for the company right now is to drive ADCETRIS, PADCEV into TUKYSA, into major block blockbuster brands, sorry, excuse me. The next priority would be finding drugs, four, five and six. And we think we've got a great stable of assets within our portfolio that can hopefully deliver on that. And then the third is continuing to be leaders in innovation around the ADCs and the other technologies that we're developing within our research teams. So that's generally what we're focused on.

And I think now having a capital position that we have now after the third quarter license fees from Merck, and in the fourth quarter stock purchase that just closed a few days ago, puts us in incredibly strong financial position to really execute on those.

You had also asked about M&A, and I think, our history with M&A is good. The cascading acquisition a few years ago, I think, is a testament to that. And that brought us a really best-in-class, first-in-class tyrosine kinase inhibitor targeted to HER2. And I think if we can continue to find opportunities like that, we'll continue to position ourselves to successfully bid and win on M&A transactions.

[Greg Harrison, Bank of America]

Great. Thanks a lot, guys.

[Operator]

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

[Andrew Berens, SVB Leerink]

Thanks. Roger, can I get your run through the design of the TUKYSA in the adjuvant breast trial? You planned and assumed part of the efficacy will be related to CNS activity. What percentage of early breast cancer patients have CNS mets as a side of relapse?

[Roger Dansey, Chief Medical Officer]

Sure. Thanks for the question, Andy. So, yes, as I indicated earlier, the U.S. college group, the Alliance is running a trial COMPASS RD. And essentially what it is, at a sort of conceptual level, is it's an evolution of the KATHERINE trial. So it’s taking patients who receive neoadjuvant therapy and do not achieve a pathologic complete response. And the design is to randomize patients in that circumstance, which is where Kadcyla was used in the KATHERINE trial and randomized them to Kadcyla alone, or Kadcyla plus trastuzumab.

So obviously we have generated data with Kadcyla plus trastuzumab. In the metastatic space, we found that very exciting, and we started Kadcyla Tucatinib combination in metastatic disease. So I think the whole thing sort of fits together nicely and flows. And you are right, the outcome, one of the end points we'll be looking at the frequency of development of brain metastases. And it is one of the sort of more outstanding sites of recurrence that was reported with the Kadcyla trial. So that is part of the focus, but obviously it's also a general disease control approach.

[Andrew Berens, SVB Leerink]

Okay. Thank you very much. Appreciate it.

[Operator]

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

[Unidentified Analyst]

Hi, this is [indiscernible] on for Gena. Thanks for taking our question. So just quickly on the launch of TUKYSA, it has been a very strong launch so far. So could you comment about the patient breakdown if you have visibility into a second line versus third line plus? And also patient with or without brain mets?

[Clay Siegall, President and Chief Executive Officer]

So thank you for the question. We're not going to get into the exact patient breakdown. I mean it's something that internally we try to track as best as we can. But we can give you a little color on basically how has it going out there with the docs. Chip, maybe you would like to give a little color commercially. And Roger feel free after Chip, if you'd like to give a little color on just clinic and what they're used to doing out there.

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

So TUKYSA has been very well received in the market. The team is actively promoting to the full breadth of the label, which includes patients with, and without brain mets. We are seeing increasing uptick in both of these populations.

[Roger Dansey, Chief Medical Officer]

Yes, and I think to add from the clinical side, what we've been able to do is to continue to provide information to prescribers and physicians, to understand just how valuable TUKYSA is both in the non-brain mets and brain mets setting. And there's a huge amount of enthusiasm. It addresses such an unmet need. And the combination of a TKI together with trastuzumab and the chemotherapy that's well understood and is part of standard-of-care is something that physicians can readily adopt.

So I think we've brought a very important medicine forward that is making a difference in patients’ lives. And obviously from a development perspective, you'll note that most of our recent trials that have been added to ct.gov have in fact included TUKYSA. So we're interested in developing TUKYSA wherever we think we can make a difference.

And so it goes beyond breast cancer to potential in gastric cancer, potential in colorectal cancer. And we are just about to initiate a basket trial, looking at HER2 alterations, including mutants in patients, such as lung cancer. So we have a lot of confidence in this drug that it can bring value to all these diverse groups of patients.

[Unidentified Analyst]

That’s very helpful. Thanks.

[Operator]

Next question is from Jay Olson of Oppenheimer. Please go ahead.

[Jay Olson, Oppenheimer]

Hey, thanks for taking my question. It's related to a certain TUKYSA events. I was wondering if you could please elaborate on the timing of the results that we should expect from MOUNTAINEER? And also when you expect to hear back from the EMA on your MAA filing? And maybe if you could comment on your commercialization plans for in Europe? Thank you.

[Clay Siegall, President and Chief Executive Officer]

Sure. Thank you. These are all really good questions. With MOUNTAINEER we're still enrolling. And so we usually don't give guidance like on timing while we're finishing enrolling. So we're working very hard on it. Our data was incredibly strong that we presented at ESMO last year we met with regulators, we got aligned on how best to go forward in a pivotal trial. We're executing upon that and trying to get that all done and make sure not only do you enroll the patient, but we need to watch the patients because we need to get duration and stuff. And so it is an important thing to do. This is a trial that we intend to try to get approval for in HER2 positive colorectal cancer. So that's something we're working hard at.

With the EMA, there's certainly a lot going on. It is not something that we give the specifics of, it's not really appropriate for us to discuss any specific interactions with EMA on TUKYSA. We are approved in five countries through Project Orbis. We're very excited about that. The labels are really good, labels that we have through these five countries. And Roger can talk about that. And I think it's good.

And the last thing I'll answer before, maybe Roger wants to talk a little about EMA and what's going on, is commercial in the EU. Now we kept the commercial rights for TUKYSA in EU. We have built out a lot there. We have a great leader Tuomo Pätsi, we hired from Bristol, but he was with Celgene for a long time before that. And he was in charge of European operations and had, I think, $6 billion of sales under his watch. And he is very talented and he has a great team.

We have country managers in all the major countries, Germany, and France, and the Nordics, and Spain, and Italy and everywhere. So we're really excited to kick that off in a big way. And the first thing though we have is finish a lot of work with EMA and then start providing this drug to patients in need across Greater Europe. So that's something that we will be doing and look forward to and reporting on that to the Wall Street.

Roger, do you want to talk a little bit about EMAs?

[Roger Dansey, Chief Medical Officer]

Yes, sure. So, the whole Project Orbis, I think, gives you a good insight into how regulators have been viewing Tucatinib. It's really been a remarkable journey to in pretty rapid time achieve approvals in these diverse countries with pretty harmonized labels. So that's a lot of regulatory scrutiny and oversight of our program. And we're very pleased with the results. We can't comment on specifics with the EMA, but obviously the process is in motion. And we will wait for that process to play out and we'll see where the EMA lands.

[Jay Olson, Oppenheimer]

Great. Thank you very much.

[Operator]

The next question is from Steven Willey of Stifel, please go ahead.

[Steven Willey, Stifel]

Yes, good afternoon. Thanks for taking the question. I know there was a couple of questions previously on ADCETRIS guidance. But just wanted to just make sure that the updated guidance, I guess, doesn't contemplate the introduction of pembrolizumab at all in the relapsed refractory setting. And I guess, as you think about the introduction of that agent going into next year, I know that you guys have developed some pretty interesting data in combination with PD-1 already. But just kind of wondering how you think the intro of pembro in the relapse refractory setting impacts the business if at all in 2021. Thanks.

[Roger Dansey, Chief Medical Officer]

Yes, so pembro has been around for a while. And we're very pleased at a PD-1 checkpoint can work in patients with lymphoma and Hodgkin lymphoma. So, we are all about doing the best for patients we can. As we look at our commercial representation with our six labels with ADCETRIS, the treatment in the relapse refractory setting is a small component of what we sell to. The frontline Hodgkin lymphoma and front line T-cell lymphoma are substantively larger as a component of what we're doing.

And so pembro was already been introduced in relapse refractory. So it's been selling out there. And when you're in relapsed, refractory, whether you are using ADCETRIS often the patients also get pembro. And if you're using pembro, patients will also still get ADCETRIS. And as you pointed out, there's a lot of fantastic data that we have combining PD1 with ADCETRIS. That's we think even better for patients in relapse refractory, than either using each agent alone. And it is listed in NCCN. So doctors can get reimbursed to that. So when you think about a whole package there we think it is a minor – it would have a minor impact if any, on what we're doing in 2021.

So the focus is really mainly on frontline. And then we have some other exciting new clinical trials with ADCETRIS. And we'll talk about them at the R&D day.

[Steven Willey, Stifel]

Understood. Thank you.

[Operator]

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

[Andy Hsieh, William Blair]

Thanks for us squeezing in the end. And congratulations on healthy balance sheet and potentially, three new product cycles. So my question is kind of a follow-up to the MOUNTAINEER study. So, we know that the single-arm portion of the study was presented last year. And now it's been converted to kind of a randomized two arm study. So just trying to understand how you can analyze that basically going from single arm study to a randomized study.

And also just curious about the single agent arm, Tucatinib arm, could the trial form single agent use in the relapse refractory setting as well?

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

I'll turn it over to Roger to clarify some of the things that you discussed. Roger?

[Roger Dansey, Chief Medical Officer]

Sure. So thanks for the question and you're right it is a randomized trial. The main purpose though, of having the Tucatinib monotherapy is to define the contribution of Tucatinib to the combination with trastuzumab. And the way the trial is designed is that patients can get Tucatinib and then if they do not respond, we can actually add trastuzumab. So we can build on that initial monotherapy and add back in the trastuzumab.

So it's an important part of making the case that the combination of Tucatinib and trastuzumab is important for patients and has a high response rate in this population. But I don't think our expectation is that this is going to be informative for monotherapy use. It's really a contribution of components question that we're trying to answer.

[Andy Hsieh, William Blair]

Got it. Thanks for the clarification. Appreciate it.

[Operator]

Next question is from George Farmer of BMO Capital Markets. Please go ahead.

[George Farmer, BMO Capital Markets]

Hi, thanks for squeezing me in as well. Why don't you talk a bit more about PADCEV and the slowing growth at least Q2 over Q3? The pandemic has been around for a while and this notion that cancer care has been affected, certainly didn't look that way when PADCEV was launched very strongly? Do you see any other dynamics that might be happening? Do you think the market might be topping out? Is the issue about duration and anything else that you could provide would be helpful?

[Clay Siegall, President and Chief Executive Officer]

Thanks, George, I think that the docs just took this drug up very well. We got it out there into a good chunk of the marketplace and duration is fine. It's what we expected. We've been where we expected from our clinical trials here. Like I said, Cohort 2, is almost double the duration by just getting one level earlier in treatment. These patients with bladder cancer, one of the big things when you look historically is like the numbers of first-line, and second-line, third-line, they just dramatically drop off historically, because there's not a lot of good drugs to treat these patients. And the patients unfortunately succumb into disease. And that's a bad thing.

And PADCEV really is something that has really brought great hope and great results to these patients. And the patients are largely older. A lot of them are in their 70s getting bladder cancer. And a lot of them – at the early part of the pandemic, I guess, people were still coming in didn't know, but as this pandemic has worn off, a lot of the older patients are nervous about going into the doc. And so we don't think that we're seeing anything more than that. This isn't some warehousing or other things and we don't think it's docs not being interested. In fact, they're incredibly interested in PADCEV and very excited in our frontline and muscle invasive and all.

And in the future, we're going to do non-muscle invasive. So, remember our launch was only right at the end of the year at the end of December. So, we think we're where we – it's almost better than what we expected with PADCEV. And we think the drug is doing really well, and we’ll continue to do well, and expand and have more labels as we go to the future.

[George Farmer, BMO Capital Markets]

Okay, thanks Clay.

[Operator]

The next question is from Reni Benjamin of JMP Securities, please go ahead.

[Reni Benjamin, JMP Securities]

Hey, good afternoon guys. Thanks for taking the questions. After seeing the data, we feel pretty confident about TV's prospects. And I'm kind of curious how you're thinking about the strategy for TV going forward, whether it's expanding in other indications earlier lines or combinations? Can you give us some color as to how that's going to move forward and the timing for that?

[Roger Dansey, Chief Medical Officer]

Sure. Thanks, Reni. Thanks for the questions. I appreciate it. So with TV, the first data set we have had out there, it's the single agent given in patients that have relapsed cervical cancer. And that is awful prognosis, cervical cancer. And relapse cervical cancer is, I mean, super awful. It's something that we were excited to be able to bring TV forward. And you look at the data with chemotherapy and even checkpoints, chemotherapy, you look at the data with taxanes and other things, and you see like 8% to 12% response rate.

And then you look at the data with checkpoints and KEYTRUDA was approved with 14%. It's one four percent. And in fact, SLA and PD-1 high in all patients it was even less. And so when we come in with our data it's the best data that we've seen in this type of patient population of relapse, cervical cancer. So, it is, you have to put that in context for what else people can treat with.

And so I look at this and say, wow, if we can have these data, single-agent what could we do if we combine it with a checkpoint or any of these other agents? And so I'm very hopeful that we can get to a higher response rates by doing some innovative clinical trials so that we can provide hope for these patients and tools for doctors. And I think the combination is probably going to be worth it a win, probably going to win out with the best data with combination. And our vedotin ADCs work really well with checkpoints, and we've shown that over and over. So we're excited to pursue that and study that.

And you asked the question about other cancer types, we are certainly looking at that. It's too early to make comments on that. We're focused mainly on the cervical aspect, but we are looking more broadly as well. And so I think GV is something that, it is, if you asked me, we have three commercial drugs, and TV is something that, I think, is in line to be our fourth commercial drug. Obviously we need to submit and gain approval, but it’s right in line to be our fourth commercial drug. And I think right behind that we have a great dataset with LV and a great partnership with Merck now. And LV someday could be our fifth drug. And we're really excited to just keep on going making drugs and expanding each of the drugs that we have with multiple labels and trying to help cancer patients.

[Reni Benjamin, JMP Securities]

Thanks for taking the question today.

[Operator]

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

[Zhiqiang Shu, Berenberg]

Thanks very much for taking my question. Two quick ones. For PADCEV I was wondering are you running a trial, EV-103 Cohort H and J in muscle invasive bladder cancer. Wondering if you would report data soon and how that trial is going?

And then also can you provide a bit color on the opportunity for non-muscle invasive? I know you talked about earlier before that you are evaluating the opportunities.

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

I missed the second part, what was it? I just couldn't hear you.

[Zhiqiang Shu, Berenberg]

Color non-muscle invasive bladder cancer opportunity how is the planning going? Thank you.

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

Got you. Okay, Roger, can you help in and talk about the bladder cancer questions?

[Roger Dansey, Chief Medical Officer]

Yes. Thanks for the question. So, EV-103 trial has multiple cohorts, probably the most important of which is cohort K, which is our accelerated approval path forward in metastatic [indiscernible] patients combined with KEYTRUDA. But you're right, we are in fact prior to us entering into these agreements with Merck and Merck offering us the opportunity to move PADCEV fast into muscle-invasive disease, we do have signal seeking cohorts. So they're enrolling well. We can't comment timing for that, but I can tell you the trial continues. And obviously when we have that data we will share it.

Just from a general sort of medical scientific perspective, Nectin-4 is fairly expressed at a high level across all of these different disease states. So, as a hypothesis, I think, it's reasonable for us to put forward that that VE will be active, PADCEV will be active as it is in metastatic disease we expect activity in muscle-invasive disease.

And then to answer your question about non-muscle invasive disease, which also has meaningful unmet need yes, we are continuing to work on our plans. We are just not ready to share them at this point. But we have done some preclinical work and when we have a plan that we can share public we will bring it forward.

[Zhiqiang Shu, Berenberg]

Thanks very much.

[Operator]

This concludes our question-and-answer session. I would like to turn the conference back over to management for any closing remarks.

[Peggy Pinkston, Vice President-Investor Relations]

Okay. Thank you, operator. And thanks everybody for joining us this afternoon. Be well.

[Operator]

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.