Q2 2021 Seagen Inc Earnings Call
And second quarter 2021 financial results conference call on.
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I would now like to turn the conference over to MS. Peggy Pinkston Senior Vice President of Investor Relations. Please go ahead.
Thank you operator, and good afternoon, everyone I'd.
I'd like to welcome all of you to <unk> second quarter 2021 financial results Conference call. This afternoon, we issued a press release with our results and the press release and supporting slides are available on our website and the investors section events and presentations page.
Speakers on today's call will be close to Gal, President and Chief Executive Officer Todd.
Todd Simpson, Chief Financial Officer, Chip Romp Executive Vice President commercial U S and Roger Danzy, Chief Medical Officer. Following our prepared remarks, we'll open the line for questions. We aim to keep this call to 1 hour and so ask that you limit yourself to 1 question to give everyone an opportunity to participate and 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 and.
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 season is contained under the caption risk factors included and the Companys quarterly report on form 10-Q for the quarter ended March 31, 2021 filed with the Securities and Exchange Commission and the company's subsequent reports filed with the SEC and now I'll turn the call over to clay.
Thank you peg and good afternoon, everyone.
This was an exceptional quarter for our business in terms of commercial performance as well as regulatory and clinical progress. We're pleased to report the highest ever net product sales across each of our approved medicines as well as the highest sequential quarter over quarter.
And <unk> dollar growth and product sales and our history.
These results reflect strong commercial execution across pad, 2 kaiser and et cetera.
Our financial strength is driven by product sales as well as royalties and multiple strategic collaborations we.
We ended the quarter with $2.5.
And cash and investments and have no debt.
This positions us to expand our programs advance our research and development and continue investing and our business.
We remain focused on maximizing the opportunity and value of our approved drugs and.
Developing additional transformative.
And of cancer therapies for patients around the world.
We look forward to share and key business regulatory and commercial and development updates on the call today.
We are focused on 3 strategic priorities that empower our ability to drive innovation growth and substantial benefit for our stakeholders, including.
5 Billy's oncologists are communities shareholders, and most notably cancer patients.
Our first strategic priority is to maximize the global potential of our 3 approved medicines through robust clinical development and exceptional commercial execution.
The first product I would like to highlight is <unk> a first in class ADC that has quickly become standard of care in previously treated metastatic <unk> cancer earlier. This month FDA granted pads have regular approval and the U S. Based on data from the phase III EV 301 trial.
Employees demonstrated an overall survival advantage for patients treated with <unk> versus chemotherapy.
Full approval is important for the commercial team is inclusion of the OS data allows for promotion of <unk> demonstrated clinical benefit.
<unk> was also granted a second indication.
While picking at the first and only FDA approved therapy for Euro <unk> cancer patients, who are cisplatin ineligible and have previously received 1 or more therapies.
As a meaningful proportion of bladder cancer patients cannot tolerate cisplatin based chemotherapy. There is an urgent need for more treatment options.
And those pads.
In addition to supporting regular approval and the U S. The EV 301 data supports global regulatory submissions, which we and our partner Astellas continue to move forward.
Yeah.
Another key product is to Kaiser a best in class her 2 tyrosine kinase inhibitor, which has become an important.
And as such as standard of care in the U S for the treatment of second and later line her 2 positive breast cancer patients with and without brain metastasis.
<unk> is now approved and 36 countries and in addition to the U S has launched in Germany, France, Switzerland and Austria.
We are actively engaging.
Importantly specific authorities to gain reimbursement and broader access for <unk> outside the U S.
We're pleased by early uptake health care provider feedback and the fact that to Kaiser has already been included and key treatment guidelines.
And <unk> broad clinical development program includes evaluation and her <unk>.
With contrast cancer as well as colorectal and gastric cancers and and other her 2 amplified or mutant tumors, we expect our.
Our strategic commercial collaboration with Merck to further accelerate <unk> global reach and regions outside of the U S, Canada and Europe.
The third product I'll highlight is et cetera.
<unk>, which is the established foundation of care and multiple CD <unk> expressing lymphomas.
Et cetera is a remarkable product that is commercially available and 76 countries and serves as the bedrock of our core business <unk>.
Enabling us to continue investing and our pipeline and other products.
And decade after approval.
Chris Etcetera, just reported its highest ever quarterly sales, which serves as further evidence of the significant benefit. It offers to patients we are committed to maximizing etcetera and reach and continuing to advance a comprehensive clinical development program and Hodgkin lymphoma diffuse large b cell lymphoma and.
Solid tumors.
In addition, our partner Takeda is pursuing approvals from frontline Hodgkin lymphoma, and peripheral T cell lymphoma and its territories.
Our second strategic priority is to advance late stage programs towards securing approvals for new products to soda map with dotan or TV.
Is currently under priority review by FDA.
Inc, accelerated approval for recurrent or metastatic cervical cancer with a <unk> action date of October 10th.
TV is positioned to be our fourth commercial product as we look to expand our portfolio further and together with our partner Genmab. We're currently.
Back with launch preparations.
This is an important development and the treatment of cervical cancer, which in the recurrent or metastatic setting has a significant unmet medical need.
Our third strategic priority is to expand our deep and diverse early stage pipeline through continued innovation.
On to encompassing antibody drug conjugates immuno oncology agents R&D investments corporate development and strategic partnerships.
In closing I'd like to recognize our employees and partners around the world, who despite challenging conditions over the past 17 months have worked tirelessly to.
<unk>, Bruce our programs and build our business. We have now begun the process of appropriately and safely returning our U S. A U S based workforce to the office in a phased approach.
Next I will turn the call over to Todd who will provide an overview of our financial results then chip will discuss.
Thus our commercial performance after that Roger will provide an update on clinical development activities and our pipeline Todd.
Great. Thanks, Clay and thanks to everyone for joining us on the call. This afternoon are financial results reflect significant advancements made across the business today I'll summarize our.
From interim results for the second quarter and year to date, which are in line with our expectations for the full year.
Total revenues were $388 million and the second quarter and $720 million for the year to date in 2021.
Product sales from our 3 oncology franchises totaled $347 million in.
Our final quarter, representing 15% sequential quarterly growth and 44% growth over the second quarter of 2020.
This reflects revenues across our diverse commercial portfolio, which now has international reach.
Royalty revenues were $36 million and the second quarter and <unk>.
Second $4 million for the year to date in 2021.
Over 2020 reflects increasing sales of etc, Spike Takeda as well as royalties on sales of <unk> by Roche and blend rep by GSK.
As expected collaboration revenues were modest at $5 million and the second quarter.
$67 million for the year to date in 2021.
Cost of sales increased to $78 million and the second quarter and $142 million for the first half of 2021. This included product cost of sales and royalties for each of our 3 brands the pads of gross profit share.
And so Dallas, which was $39 million and the second quarter and $71 million for the year to date as well as noncash amortization of acquired technology cost forward to Kaiser.
R&D expenses were $235 million and the second quarter and $465 million for the first half of.
2021.
These are increases over 2020 and reflect increased investment across our early and late stage pipeline.
SG&A expenses were $165 million and the second quarter and $325 million for the first half of 2021.
These are any.
Increases over 2020, reflecting investments to support European Takeda launches and.
And our global expansion efforts.
Lastly, we are maintaining our 2021 financial guidance and we're pleased with our performance in the first half of the year.
We have significant financial strength, which allows.
To continue investing and our pipeline and business.
Now I will turn the call over to chip for an overview of our commercial performance.
Thank you Todd performance across the commercial portfolio was strong and Q2 and we believe we are emerging from the pandemic with positive momentum we are well positioned to drive continued.
<unk> growth with non recent past sub label expansion additional country launches for <unk> and the potential approval of TV and.
We are seeing a meaningful increase and the number of in person sales calls by our field team and our commercial infrastructure and capabilities are in place to maximize future product launches.
Accessories delivered a.
How's this quarter and noteworthy accomplishment for a 10 year old brand et cetera sales were $182 million, a 9% increase over Q2, 2020, and a 12% increase in volume over last quarter.
Our field sales force and returning towards normal call activity levels with mostly face to face interactions.
A record we are now actively promoting the landmark 5 year echelon, 1 progression free survival data in frontline Hodgkin lymphoma.
And as featured in the Lancet hematology publication.
This is meaningful data to physicians and patients and solidifies, the etc regimen and as the best option for frontline stage 3 or 4.
And on lymphoma patients.
Moving on to pad sales second quarter sales were $82 million, a 44% increase over the second quarter of 2020, and and 18% increase over last quarter we.
We are pleased with the conversion to full approval for passive and a new indication for cisplatin ineligible metastatic.
You're a female cancer patients who have previously received 1 or more lines of therapy.
And our ability to now promote this new indication should drive incremental uptake, representing a meaningful but modest opportunity as.
As we've discussed on past quarters, non metastatic <unk> cancer setting continues to evolve and we are confident that Pat.
And well positioned to remain the standard of care.
Transitioning to <unk> second quarter sales were $83 million.
And increase of 18% over last quarter.
Our U S launch has been very successful and we continue to see high levels of utilization and patients with and without brain Mets.
And on patients.
Pat settlements to case it is the most utilized product and second and later lines for her 2 positive breast cancer.
And Europe early uptake has been very encouraging, notably with recent launches and France, and Germany, the strength of evidence, including demonstrated overall survival benefit from the heart to climb trial along with favorable.
Clinical guidelines gives us confidence as we execute our reimbursement strategy in Europe.
And finally, we are pleased that the TV BLA received priority review and if approved this would be and important new drug for women with previously treated metastatic cervical cancer.
The team will be ready ahead of the October 10th <unk>.
<unk> date.
With a dedicated sales force in place.
We are starting the second half of the year with great momentum across our portfolio of first in class or best in class products and look forward to potentially adding another important medicine soon to our proven commercial model now.
Now I'll turn the call over to Roger to talk about our robot.
Development activities Roger.
Thank you chip and good afternoon, everyone and happy to share recent clinical development updates for our approved medicines and our pipeline.
I'll start with pet sales.
FTA originally granted <unk> accelerated approval for the treatment of patients with locally.
Advanced or metastatic <unk> cancer, who have previously received a PD, 1 or PDL, 1 inhibitor and a platinum containing chemotherapy.
Continued approval was contingent upon confirmation of the clinical benefit in the EV 301 pivotal trial. The FDA has now granted pets and regular approval.
But based on the trial success, which demonstrated improved survival among patients who received <unk> compared to those who received chemotherapy further the paths of U S. Prescribing information now includes a new indication from the cheapened metastatic <unk> cancer patients who are ineligible for cisplatin.
And have previously received 1 or more prior lines of therapy the.
And the new indication was also granted regular approval and is based on cohort 2 of the EBIT to a 1 trial.
These results were recently published in Lancet oncology and were updated with additional follow up in the presentation that <unk> 50.
51% of patients achieved a confirmed objective response with a median duration of response of $13..8 months. These data are clinically meaningful in the setting of high unmet need with patients are older and those suffering from multiple comorbidities, commonly including kidney function.
We are pleased with the broad nature of the second indication, which does not specifically require prior PD, 1 or PD lone treatment. Additionally.
Additionally, the new label has been updated with important safety information, which further informs physicians on how to safely use headsets.
The clinically compelling.
Passive data have enabled substantial regulatory progress outside of the United States with marketing applications. Currently under review in the EU, Australia, Canada, Japan, and Brazil, Switzerland, and Singapore.
I'll turn now to the first line metastatic <unk> cancer.
At <unk>, we presented updated durability and other long term outcomes from cohort of the EV 103 trial evaluating <unk> plus keytruda in cisplatin ineligible patients.
The data showed a continued objective response rate of 73% and median duration of risk.
Extending to $25.6 months Encouragingly median PFS was $12.3 months and median OS was 26.1 months.
Safety profile of this combination was generally consistent with previous findings.
We are using the same regimen and cohort K.
Sponge is intended to support accelerated approval and we expect to complete enrollment of this cohort by the end of the year.
In addition, we continue to enroll patients into the phase III EV 302, global trial, which includes both cisplatin eligible and and eligible patients.
<unk> patented.
<unk>, plus keytruda compared to a platinum containing chemotherapy regimen.
Abroad paths of development program also includes 2 phase III trials in patients with muscle invasive disease, both trials test passive and combination with keytruda.
Keynote to be 15, or EBIT, 3 or 4 trial is enrolling.
And with cisplatin eligible patients and keynote <unk> 5 on EV 303 trial is enrolling cisplatin ineligible patients. Additionally in the next few months, we expect to initiate a dose fund and trial of single agent <unk> and non muscle invasive bladder cancer <unk> will be administered intravenously.
Enrollee in BCG and nonresponsive patients net 1.4 is highly expressed and non muscle invasive bladder cancer and there is promising preclinical data to support the potential opportunity with <unk> to be active and necessity.
We are also evaluating pets and the basket trial of high net and.
Basic addressing solid tumors, including lung breast head and neck, gastric and esophageal cancer and we await initial data to inform on next steps.
Turning now to <unk> and <unk>, we presented long term data from the <unk> trial.
The primary analysis upon which to Kaiser was approved was conducted.
And Forex with 14 months of follow up this presentation and extended the time a follow up to $29.6 months. The updated median overall survival increased to $24.7 months from the <unk>.
And with benefit maintained across all Prespecified patient subgroups.
And there has also been.
And a recent update to the NCC and treatment guidelines for patients with CNS involvement 2 kinds of plus Trastuzumab and Capecitabine is now the only regimen and assessing where the category 1 level of evidence.
And earlier stages of breast cancer, we are evaluated and 2 kinds of plus cash silo versus <unk> alone.
And first and second line metastatic patients in the <unk> plus <unk> trial, we and Merck intends for this trial to support global approvals, including in China.
And high risk adjuvant breast cancer enrollment continues and the randomized <unk> trial evaluating <unk> plus.
Curt silo versus <unk> alone, which is being run by the alliance Cooperative group.
And Gi cancers, we remain on track to complete enrollment and the mountaineer trial by the end of 2021. This trial is intended to support an accelerated approval in the United States for patients with advanced flow to positive colorectal cancer.
Cancer also we are advancing to Kaiser and simple studies, including in combination with look solid platinum based chemotherapy in first line and Gi cancers.
And a basket trial for solid tumors alterations that include mutations.
And in combination within her 2 from her 2 positive breast cancer.
Moving on now to its interest we are pleased that the issue and 1.5 year manuscript was published in lancet hematology during the second quarter as we have discussed results demonstrated robust and durable remissions in patients with newly diagnosed advanced Hodgkin lymphoma, who received ADCETRIS in combination with Abd.
Importantly, we also saw fewer second malignancies, and more pregnancies and patients on the ADCETRIS arm of the trial.
We continue to execute our <unk> clinical development program that includes echelon and 3 our phase III trial in relapsed diffuse large b cell lymphoma, which compares et cetera plus revenue.
Revlimid and Rituxan versus Revlimid and Rituximab.
And frontline advanced as well as early stage Hodgkin lymphoma, we are evaluating ADCETRIS in combination with the volume at Adriamycin, Dacarbazine and and solid tumors, we are evaluating ADCETRIS as and immuno modular 3 agents in combination with Keytruda.
<unk>.
I'll turn now to TV, which we are developing in collaboration with Genmab.
The BLA currently under review is seeking accelerated approval of television for the treatment of women with previously treated recurrent or metastatic cervical cancer.
And supported by data from the innovative 2.
A full trial, which was recently published and Thats in oncology. In addition, we are enrolling the innovative 301 global phase III trial in a similar population that is intended to serve as the confirmatory trial in the United States and to support global regulatory applications, We believe television.
Sure that make a meaningful difference for women with cervical cancer, where there is such a high unmet need.
Our next goal is to bring TV into earlier lines, and metastatic or recurrent cervical cancer and for that purpose. We are conducting the innovative 2 or 5 trial in first or second line and.
In this trial.
And you could really awaiting TV in combination with chemotherapy, all keytruda and we expect to report data at a medical meeting before the end of the year.
Turning now to <unk> and we are working with our partner Merck focusing on optimizing dose and schedule as monotherapy and in combination with Keytruda and breast cancer.
We plan to present data from <unk> later this year.
Next I'd like to highlight the breadth and depth of our early stage pipeline. We are advancing 7 programs in phase 1 clinical trials across a range of solid tumors and hematologic malignancies. These include the Adcs SDN Cdti to Asia.
We are going to be 6 day and <unk>.
And we expect to submit <unk> for at least 2 more ADC programs this year and.
In addition, we have 4 effector function enhanced antibodies utilizing on SCA technology, including <unk> 46, 70 <unk>.
CMA and tickets.
With regard to CD 40 earlier this year, we completed enrollment and a clinical trial evaluating as part of a combination regimen and the treatment of pancreatic cancer. We expect to report clinical data from the trial sometime either later this year or early next year as the day to mature.
We are also planning to initiate a basket trial to evaluate <unk> and other solid tumors.
In closing we have achieved many important milestones and have made significant headway across our pipeline and the first half of 2021, we look forward to providing you with further updates on future calls and now our term.
Call back over to clay.
Thank you Roger on <unk>.
Proud of the remarkable progress, we have made and growing and evolving our business and technology, enabling us to develop exceptional oncology therapies today, we have a deep and diverse pipeline a multi product commercial portfolio.
On the additional potential approvals on the horizon.
Strategic partnerships, our expanded global infrastructure and substantial financial power fuel our ability to advance our portfolio, including our early and mid stage pipeline.
Our robust clinical development program and proven commercial.
And engine demonstrated our ability to compete and the marketplace and we are poised to maximize new assets and future launches.
With our solid foundation, we are operating from a position of strength and are confident and our ability to continue delivering cutting edge innovation and transformative medicines.
<unk> for cancer patients worldwide.
Operators. Please open the line for Q&A.
Yeah.
We will now begin the question and answer session to ask a question you May Press Star then 1 on your Touchtone phone.
If youre using a speakerphone please pick up your handset before pressing the keys.
And you can withdraw your question. Please press Star then 2.
At this time, and we will pause momentarily to assemble Iraq okay.
All right.
Our first question comes from Andrew Barron with SBB Leerink. Please go ahead.
Hi, Greg.
On the strong ex.
And guys this quarter.
I know you've given some guidance about the addressable markets by line of therapy for pads have and the path. So I was wondering if you could tell us how much you think the label expansion for the second line increases.
Dressel market now and how saturated do you think patents of his and the third line.
Thank you for the questions and the comments and.
And we're really pleased with the broad label that we got for pads and there was.
The 301 study confirm the existing label and then that cohort 2 and we called it gave us a new population of patients.
<unk> that were assist and eligible.
We believe that some of these patients are likely getting unprovoked it use.
Of the drug and that setting is.
It's very hard to know how many and it certainly.
And we don't think it was zero.
So we'll continue.
And to monitor the impact of this new indication on.
On the commercial uptake of this but we feel really great about and the new labels.
Yeah.
Okay.
How saturated do you think it was.
And third line setting and it was originally approved and.
You know I think were you know we got to.
Standard of care pretty quickly there and docs really embraced using it on.
And I you know I I don't think we were 100% saturated.
And it's hard to give guidance on it.
For what's.
Happening. It's also you know it feels like we're coming out of Covid, a little bit, although we have the new variance who knows.
And you know so it's really hard to give exact guidance, but I think we have room to continue moving.
Stream with pad SAP, it's a great drug and doctors are embracing it.
Okay. Thanks for the color Clay I appreciate it.
Sure Chip would you like to give a little color on this so absolutely I think it's just important to note that this is a dynamic market and with the advancements in treatment with regard to maintenance.
And we are seeing more and more patients become eligible for pads on earlier in their treatment journey than they would have in the past.
Yeah.
Our next question comes from Sal being Ritchie with Goldman Sachs. Please go ahead.
Good afternoon.
And congrats on a nice quarter could you comment on the trajectory of your products and second half given there is suggestion of negative growth for et cetera, and <unk> for your guidance and then what drove the inflection for et cetera. This quarter.
Okay, well, thanks very much for the questions on everything we're not trying to.
Provide down guidance on everything and it's just hard to really know exactly what will happen.
As we either get out of Covid or not and so we just wanted to be.
Prudent with our guidance and we watch things very close on this Todd do you want and gets a little bit of color on.
And to what we're thinking about in terms of financials and guidance sure. So thanks for the question on solving first of all start off by saying, we don't try to give quarterly guidance, we give annual guidance and the reason for that is quarters fluctuate. We just came out of a very strong quarter, which we're delighted about.
Q2, typically is a strong.
Long order for especially compared to Q1, and when you annualized first half of the year and compare that to our guidance and we think our guidance is appropriate which is why we've maintained it.
But theres a lot going on and we're really pleased with what we're seeing the year's off to a great start it's terrific to get our field.
For the most part back into the field, which is.
And where they can do their best work.
And there are a lot of things that we're tracking for example, with et cetera.
And we've now we're now promoting to the 5 year data, we're looking at return of patients and the clinic.
Out of the out of the pandemic, but.
Team frankly, a little too early to tell exactly what's going on for patents, we're looking forward to now.
And now promoting to the cohort 2 wafers, which you know as you heard on the call is incremental because we are probably getting some of those patients before and then with Takeda and we're delighted to nail complement that.
The U S launch with now launches starting in Europe, most notably in France, and Germany. So again, we're really pleased with how the year has gotten off to a start and feel like we're in good position going into the second half.
Great. Thank you.
Our next question.
It's from Kennan Mackay with <unk> capital markets. Please go ahead.
Hey, Thanks for taking the question and congrats to the team on a really terrific quarter. Here. This is often awesome to see after the seasonal weakness in Q1 and COVID-19 impacts there maybe on the commercial side.
Side of things for clay or.
Chuck can you maybe talk to U S trends versus ex U S and European trends and perhaps how that Q2 outperformance related to easing of COVID-19 restrictions and.
Any commentary you can give on early signs of how thats continuing into Q3.
And I'd love to hear any commentary.
Jim could give around U S versus European growth, especially as it relates to the geographic expansion for it to Kaiser.
Sure and thanks for the comments and questions on chip.
Chip can you try and talk a little bit about U S trends and what Youre seeing with all 3 brands.
And as it relates to COVID-19.
You can start there and then we'll get into the U S versus European sales.
And so absolutely clay so as far as et cetera goes I think this is an opportunity to show how the 5 year data is resonating with physicians or 5 years is an important and meaningful end point for for.
Positions this shows the durable.
Aspect of the original trial that we did on this et cetera.
And I think in addition to that we have some publications that have put out in June and the lancet hematology, which represent this dataset I think we're getting traction with that now and et cetera.
I think as far as passive goes I spoke earlier about the dynamic nature of the market what we're seeing is that.
As the market continues.
And to change more maintenance therapy is being used and pads that are being used and earlier lines. As a result of that we are excited to have the new label to where we can promote versus line and eligible patients and we think we will get traction from that.
And then with regard to case of the case and it has demonstrated an overall survival benefit and the her 2 climb trial.
And this really resonates with physicians and has helped us to continue to gain share in patients with and without brain Mets.
And concerning the European question of the U S trends European.
We're really excited.
And with going into Europe, we have a broad approval through all.
But we only have a few countries that we have reimbursement to date so on.
Most of our sales are coming from the U S. Because there's only a few countries and there, but we expect over time to get all of those countries reimbursement and so it takes a little longer to get reimbursement in Europe, There's no issue no problem.
Europe is all what we expected and you've seen before with other products.
And so things are going well, there, but it's really hard to give you a day.
And in a answer on that.
Ex U S trends, which Kaiser since we're pretty early in the game there.
Totally got it and maybe just a follow.
And so up clay or perhaps 1 for Roger.
And the potential for <unk> to move into pre muscle invasive bladder cancer.
And from a secular dosing is super interesting given the potential to transform that that market and maybe you can elaborate alleviate the reliance on cystectomy.
And you have that and linker that maybe uniquely.
And equally enables you to perform that interdicting on delivery can you maybe talk a little bit about how you're thinking about going forward potentially into that market. There I know, it's early but I'd love to understand it and they said, whether youre thinking about combinations, either with BCG or checkpoints or simply planning to evaluate that monotherapy activity before making any decisions.
And congrats again.
Great question, Canada, and really good question, Yes, we're very interested and Roger can you take this and see a.
The best way to address that yeah, thanks, clay and and and.
Thanks for the Great question I think you know.
We've got strong preclinical evidence to move forward the value proposition.
Acquisition of giving.
You know something like pets into the bladder because the the main body of people, who treat patients with superficial bladder cancer is urology and urologists.
They've been better so it's a really good sort of its a good match.
The disease state.
States.
Because we.
We expect the systemic exposure of pets have to be very limited and so the safety profile could be quite promising.
And you know as I said in my prepared remarks, our Nexen and 4 is expressed and non muscle invasive bladder cancer and I think Ken and all of the things that you've raised.
Where could we go with this and what populations could we address I think those are all at least.
Basically on the table, but we have to start at square, 1 which is lets take the people who failed BCG and see if we can reverse the disease states. So that's that is.
Starting point.
We need to prove.
And that pets of Ken and effect.
And I have impact on those lakes sort of.
Non muscle invasive bladder patients and once we've got that and we can determine what its profile. It looks like then I think the development in non muscle invasive bladder cancer can go as far as we like.
As you know.
<unk> was approved there are some other agents that are approved.
On the goal is to clear the disease and so depending on the efficacy profile, adding another agent.
Would it would be a reasonable thing to do.
Our next question comes from Geoff Meacham with Bank of America. Please go ahead.
Hey, guys and SaaS proper job. Thanks for the questions just a couple on the commercial launch for T V.
Basically just wanted to get some more color on on what needs to be done and what what exactly has been done.
For that and maybe how and.
How do you Ah emerging variants kind of play into your thoughts on what that launch might look like and the U S and any learnings you can take from there on the mid.
Pandemic to keep the launch OLED TV it would be helpful as well thanks.
Sure look we're really excited about.
And to potentially getting a port product I say potentially because it's not approved yet I asked you, a but where we submitted a file and we're working hard with them to try and get this thing on the market to help patients do per day is I think October 10th and and you know we're working hard towards that.
Lot of work.
And you behind the scenes that.
And nobody knows that companies do when they were trying to launch product.
Chip can you talk a little on the commercial and what we're seeing and whether you think there's any debt.
Anything going on with the Covid various but in general can you talk a little bit about how we're thinking about this launch.
Yeah, absolutely clay so the.
<unk> been working for over a year now I'm getting the right structure the right.
Roles and place associated with this we have a fully staffed a dedicated sales force, which is going to work and co promotion with Genmab.
In the U S. So we've got a corporate partner that we're looking forward to partnering the product becomes.
<unk> approved.
In addition to that you know this is an important and kind of unmet medical need metastatic cervical cancer is a devastating disease.
And I think theres going to be and opportunity for improvement potentially and outcomes with a product like this.
Far as the Covid commentary goes we most of our field sales force is now out making feast.
And to face calls or most of our calls I should say our face to face we're continuing to monitor what happens and it's you know.
And unforeseen future with regard to these variance, but what we do have is a model, which you know on a full.
Virtual launch behind US, we can leverage that experience should things and the future.
And a change and we will do that.
But our plans right now are really to build upon the successful launches that we've had leveraging the right parts of that infrastructure when necessary.
Thank you.
Yeah.
Our next question comes from Michael Schmidt with.
Sure Chris.
Go ahead.
Hey, guys. Thanks for taking my questions and congrats on a quarter ex left from me I had a couple of pipeline questions. Maybe first on the left 1 a data that we saw that title for the upcoming and small presentation and Roger on the weekly dosing schedule and just wondering.
And what are you looking for and its data and how it will guide our next development steps and breast cancer and then on on the CD 40 antibody.
Pancreatic cancer is obviously, a huge potential market opportunity, but it also has been difficult in terms of drop through all of them and historically, what do you need to see and the single arms.
Armed and Saudi if you really are and that really gives you confidence and and this combination to potentially succeed and a future phase III trial. Thanks, so much.
Yes.
Go ahead.
Yes.
Thanks, and thanks for the question so.
L.
Run rate is.
As we have said a few times, though we are continuing to work on optimizing dose and schedule and the first piece of data that we have.
And that will be sharing and will come up at ESMO and we are still work, we're working with our partners.
It is an active agent of that there is no doubt both.
As monotherapy and in combination.
And we're trying to find the sweet spot of what is the right dose and what is the right schedule and so that's our plan with Lv and Youll see some day they are coming up at ESMO with regard to CD 40, I, It's a great question.
Just from a science firstly, we haven't we haven't we have.
Have a well defined CD 40 agonists, we understand the dosing as a monotherapy we have some activity as a monotherapy so.
Todd is clear with regard to the scientific concept of combining a CD 40 agonists together with chemotherapy and a PD 1 inhibitor, that's exciting and that doesn't necessarily have to limit itself to pancreatic.
And so and that's why.
We're indicating that we're interested in pursuing a basket trial and tumors that may in fact be more immune manipulable and something like pancreatic cancer with regard to what data do we need to see.
And as you pointed out pancreatic cancer has been a very difficult disease to develop.
And it comes in and.
People have been misled with small numbers and focusing on sort of early and points to.
And to find out and large trials that.
And when it doesn't show any improvement over standard of care. So I think we interested without getting into the details of what exactly we would like to see we are interested.
Developed in all endpoints, which will include what is the response rate and look like on the front end.
How much disease control can we get that'll be measured by PFS and most importantly, what is the survival curve looks like and I think all 3 of those elements.
Need to be part of our evaluation.
Once we have the data.
Great. Thanks, so much Roger.
Our next question comes from Corey pass them on with J P. Morgan. Please go ahead.
Hey, good afternoon, guys. Thanks for taking the question and I wanted to follow up on the a and the F. D. A C D 40 program.
And.
I guess first of all what determines whether we'll see that as 40 data later this year versus early next is it getting kind of that early look at those survival curves. As you were just talking about Roger and when we do see the data I believe like with pancreatic or the expansion cohorts grow up to 75 patients per indication.
Were all the pancreatic patients on the same combination or there are a variety of combinations being evaluated thank you.
Yeah, Thanks, and thanks for the question.
And with with regard to the last piece that we have focused on the same combination. So it's you know it's the.
It's the.
Standard chemotherapy, plus Kimberly and that plus on CD 40, so.
No the triplet in that component is in fact the same.
With regard to timing I mean, you're exactly right, we need enough maturity on all the endpoints in order for us to make our best estimate as to whether.
This is worthwhile taking into a pivotal trial and we need to do more work.
And so in terms of the timing of when that data will be available. It sits on the cusp of the year and so it's very hard for us to predict.
Will we be able to share the information in 2020 or will it.
And it will it go into.
Sorry, not 20 and train them on a year behind 2021 or will it be in 2020, 2 but when we're monitoring very closely and.
And as soon as we believe we have mature enough day, though you know, we'll we'll get it out on the public domain.
Okay. Thank you.
Okay.
Okay.
Our next question comes from Gena Wang with Barclays. Please go ahead.
Thank you for taking my questions and so I thought 1 question regarding the Daiichi litigation I know the arbitration decision should be anytime now.
I'm just wondering how will you share.
A discussion with us and how what the decision and Pat.
And next steps and also the other and ongoing litigation.
So thanks very much for the question on our litigation.
I like to say first of all that over our history of.
24 years, we are not a litigious company.
We have only taken action that's appropriate to defend our IP and our contractual rates. So this is not something I hope you'll see from us on a routine basis.
And the arbitration hearing was conducted in June.
And.
We expect a decision sometime later this year.
And from the arbitrator.
And so things are proceeding according to the schedule that was set by the arbitrator and so right now we think everything is proceeding and AR and AR expected standard way and you know nothing is unusual from what we.
Scene.
But you know and.
And we're going forward there we will provide updates.
And as soon as we have them and when we are permitted to in the process. So we're not going to hold something just for ourselves and as soon as we can do stuff, but I want you to know that we feel very confident and our position.
And we.
And we feel like it's a very important to defend our legal rights and.
And protect the innovation that we work on so hard and deliver for patients.
And so that's really where it is and you asked a question on you know what's the next step well it depends on what you know.
And it comes out of.
And the arbitration, so it's hard really to predict the next step but we.
We feel very good about our case.
You asked also I'm sorry about the other litigations and there was also a patent infringement.
Lawsuit that that's not going to court till sometime next year. So that's a little different that's not in front of an arbitrator and that's.
And of course and.
And so that's ongoing as well and we feel good about that 1 as well.
Great. Thank you.
Okay.
Our next question comes from is that challenge you with Darren Berg. Please go ahead.
Actually you're right.
Thanks, very much for taking my questions and congrats on again on the great quarter and.
And I have 2 questions 1 is related to our citrus and so on.
Obviously, it's a it's a strong quarter after a few second quarter.
I was wondering.
This growth is it a reflection of.
And the pandemic is behind us or is it a result of the 5 year.
5 year data that compelled the physician.
To prescribe the drug and that's the first question and I'll ask citrus and the second question and it's related to.
On your tissue antibody.
Thank you share some very interesting preclinical day last year and your R&D day.
Was wondering do you plan to share more data on this program.
And in line of our you know the.
The debt and you do on Nancy and.
And the field.
And how you are thinking around this asset and you've already thanks very much.
Sure, let's start with the ADCETRIS question, Yes, Indeed, we had a strong quarter, we're really excited and I think you know there might be something about.
And then they starting to wane although.
Continue to monitor that and then.
Okay.
Well I'm, sorry from less mobile.
And just to your question.
And and then there's the 5 year data debt chip referred to so I think you know chip you may want to comment here with more color on.
And it gets a little bit of both not just 1 or the other chip what are you thinking.
So I would agree with you, but I can speak to the 5 year data with regards to feedback from our physicians and customers. They have found and this data to be compelling.
[noise].
And I think you asked a question about the Tianjin.
So you know tissue and.
We have a differentiated kitchen and Oh Rogers development team is developing it and.
No.
You know I think they.
And to put out data at appropriate times, Roger do you want to provide any color on that.
Yes sure.
No. It's a great question you know I think we certainly pre clinically we see outages as a best in class I mean, we absolutely understand that this is this is a competitive environment.
And so you know we're working hard on coming up with a development plan our.
That will.
And.
Have the.
Opportunity or give us outage and the opportunity to showcase itself.
And move as quickly as possible if its purpose into pivotal trial. So what I can say is that the the to just development.
The development team is excited by the opportunity.
We are enrolling well, we're working on things like defining dose and schedule.
And it's at which is what 1 does in a phase 1 trial and thinking very carefully about where we would like to expand our <unk>.
On the ration, including and obviously and combinations so noticed no details to disclose.
But lots of forces going on and into that program.
Great. Thanks very much.
Yeah.
Our next question comes from Jay Olson with Oppenheimer. Please go ahead.
Oh, Hey, congrats on the quarter and thank you for taking the questions can you talk about what lines of therapy, you're seeing.
In the U S and.
Schedule up for to Kaiser and if theres any spontaneous and promoted use and in first line.
And then.
Can you also talk about any impact you might be seeing from true Lv tu pad, 7 and bladder cancer and any feedback that you're getting from doctors and related to that.
Efficacy and safety profiles or how.
How the 2 compare and clinical practice. Thank you.
Sure.
On the day Kaiser fronts.
Could you address like where it's used and lines and then I'll come back to the second question, Yes, sure you know what.
And you use that we are seeing continued utilization and growth and share across all lines of therapy and in the label second line and beyond and both patients with and without brain metastasis and it's also important to note. The cases now the most utilized product and second line and later on.
Or her 2 positive metastatic breast cancer patients with brain.
And I can tell you so it's broad it's broad growth.
As far as your second question.
Adobe is not approved and bladder cancer at this point. So you know you're asking sort of ahead of time what it is.
And we have some fantastic data and survival data.
And that we're not expecting much impact from Shelby I think that largely would be used after.
And so if I think pads have has such Premier day, and we're focused on also frontline and getting that but even in the setting where we are with survival data.
And you'd be hard pressed for Doc to use out ahead.
And other product, but I'm glad that should all be exists and I hope they get approval and could be there for patients that need it a pass up does it you know it doesn't cure every patient and other therapies are needed and so it's fine.
Yeah.
Great. Thanks, again for taking the question.
Yeah.
Yeah.
And then if you'd like to ask a question. Please press Star then 1 our next question comes from Andy <unk> with William Blair. Please go ahead.
Great Yeah. Thanks for taking my question and really glad to see the commercial inflection across the 3 key product.
Key product this quarter.
Clay in your prepared remarks, you mentioned you.
This phrase, which I found very interesting you said ADC and immuno oncology so.
I'm just curious if you're hinting that we could expect modalities beyond the sugar engineered antibody or traditional kind of day antibody.
I think or payload construct of ADC and your development pipeline.
Yeah.
So first of all our CA products, we refer to as our immuno oncology products. We also do a lot of immuno oncology work in combination with our agencies as you know from.
Body and all the work, we've done with Keytruda and Opdivo.
And many others actually it does not limit adjusted those too. So we do take into account immuno oncology. We're always looking at other ways to append things 2 antibodies and you can be guaranteed debt and our lab.
Lab, we're looking on some very interesting approaches.
Things that we won't be talking about on our conference call now, but can come out and not too distant future. So we have some exciting things that are in and the horizon, So our buckle up and stay tuned.
Great. Thank you.
This concludes our question and answer session I would like to turn the conference back over to management for any closing remarks.
Okay. Thank you operator, and thanks, everybody and so much for joining us this afternoon and have a good evening.
So.
The conference has now concluded thank you for attending today's presentation.
<unk> you may now disconnect.