Q4 2019 Earnings Call
Ladies and gentlemen, thank you for your patience and holding and welcome to de Seattle Genetics fourth quarter and full year 2019 financial results Conference call.
Today's call is being recorded it is now my pleasure.
Turn the call over to Mr., keeping skin Vice President Investor Relations Ma'am. Please begin.
Good afternoon, everyone I'd like to welcome.
Fourth quarter and shown here too.
With me today are in place to go President and Chief Executive Officer, Robin Taylor Chief.
Sure.
Uh huh.
Yeah.
And Roger Dancing, Chief Medical Officer.
Accompanying today's conference call are supporting slides, which are available on our website in the investor section.
Page.
Following our prepared remarks, well open the line.
We ask that you limit yourself to one to two questions.
Sure that we're able to get to everybody.
These.
Forward looking statements regarding future or anticipated events.
Including the Companys 2020 financial outlook anticipated product sales revenues.
<unk> expenses and timing to achieve potential clinical and regulatory milestones.
Including data read out.
Submission.
Actual results may differ materially.
Or side in these forward looking statement.
Actors that may cause such differences include the difficulty in forecasting sales revenues and expenses.
The uncertainty associated with pharmaceutical development and regulatory approval.
More information about risks and uncertainties Seattle genetics is contained under the caption risk factors included in the company.
Securities and Exchange Commission, including the company's annual report on form 10-K for the year ended December 31st 2019.
During the call over the course.
Thanks.
Good afternoon, everyone.
Genetics has entered a new decade.
Multiproduct oncology company.
Summer, we expanded our commercial portfolio.
Well Uh huh.
I have a static urothelial cancer.
Okay.
Let me start of breast cancer.
I was in 2020.
Central sort of drugs.
And then Centrus remains an important brand globally.
Revenues in the treatment more than 60000 lymphoma patients.
Hi, these three products because a robust pipeline.
Oh programs.
We believe.
More than more people in cancer.
2019 was a banner year progress positively impact future potential of Seattle.
Starting in 2020 revenues from product sales.
Well be more numbers, that's we had pets. So if approved cabinet to a strong Suntrust fish.
That said was approved in late December.
Pretty much ahead of us stupid thing.
When children.
So.
We engage with oncologist and both academic and community settings.
I'm very pleased by the positive reception to this important truck and by the number of accounts increasing number of bio born in the first for them.
So.
Early in the launch phase some catch up and whatnot.
Decided not to give sales guidance until we gain more experienced in the marketplace.
In parallel.
With our pets launch activities, we're investing in a broad clinical development programs focused urothelial cancer.
Today, we are announcing a recent completion of enrollment for a randomized phase three trial called you'd be real one.
This trial is intended to confirm accelerated approval of pass so that's important.
Applications from.
Fortunately, we have initiated in phase three trial.
Hi, metastatic disease, which is key to our global development strategies.
This trial is being conducted under our collaboration between Seattle genetics, stylish and Merck each party providing significant funding.
In addition to.
These registrational trials, we are evaluating past seven earlier stage bladder cancer I believe there was also potentially other nectin four expressing solid tumors.
Next is to cabinet, which is in line to become Mr. drug in our commercial portfolio. This program hasn't been significantly interest.
The past couple of months based on outstanding up from there to climb pivotal trial in metastatic hertwo positive breast cancer, including patients with brain metastasis.
Oh results from the trial featured in Oh presentation, San Antonio breast cancer Symposium in December and simultaneously.
Published in New England Journal of mess.
Or to climb, which supported FTD breakthrough therapy designation positions to cabinet has the potential best in class from two tyrosine kinase inhibitor.
Based on her to climb results into something we completed submission of the idea which is being reviewed.
Under the F series real time oncology ones you program.
Another significant.
Oh, sorry accomplishment went to cutting them Wednesday January submission.
In recent memory validation of the M.A. in Europe.
We're also participating in project August.
STK sponsored program.
[laughter] that provides a framework concurred submission and review of oncology drugs.
The United States, Canada, Switzerland, Singapore and Australia.
No submitted to cutting them in each of these countries positioning the drug for global approvals beginning later this year.
Our goal is to bring.
Cutting them to patients in need around the world.
I didn't mine, we're in the process and expanding our European capabilities.
Her teams in the Netherlands, Switzerland, and the United States.
Securing or an exhibition and we're adding leadership in key countries.
As Pat said we're.
Ducting broad global development program went to China.
Roger will provide additional details.
Development activities and Tom will speak to the investment we're making these important programs.
Moving on now to et cetera, I'm pleased to report record 2019 revenues.
In Canada six.
Her $20 million.
32% over 2018.
This policy, 55% growth rate in 2018, driven by adoption in frontline Hodgkin lymphoma, and peripheral T cells.
I can together with sales up in central Bank to kinda its territory global.
Sales in 2019 exceeded $1 billion underscoring its importance to physicians and patients around the world.
We expect 2020 et cetera that sell should the U.S. in Canada to be in the range of $675 million to $700 million.
All this reflects more modest growth we believe.
That are ongoing and planned clinical trials with et cetera will provide opportunities for additional expansion of the breast.
I also expect 3.5 year progression free survival results later this year from echelon, one trial in frontline Hodgkin lymphoma.
This is an important milestone for lymphoma patients and further south.
I wish to positive long term benefits et cetera, plus TBD.
A clinical stage pipeline is robust and we're conducting trials across a spectrum of human hologic malignancies and solid tumors.
Just a bad so these programs to show them up and don't want more TV, which we are developing in collaboration.
Hmm.
[laughter], our initial focus and recurrent or metastatic cervical cancer, we expect to report topline data from a potentially pivotal phase two trial and the first half of 2020.
We're also evaluating TV and other solid tumors, including ovarian and head and neck cancer activities underway topped by.
Dose and schedule.
In 2019, we initiated trials several novel agents you tend to continue our investment in innovative new product candidates, including Edcs other targeted therapies with we're I in these plants.
2020, and another 420 21.
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Early stage programs are based on efficient clinical trial designs that are intended to four important fear rapid development assistance.
We're also pleased progress I mean, you see collaborative programs, namely U.S. and recent do you approval Roche's pardon me.
Ongoing priority review by FTD.
Recent M&A validation.
Yes, okay.
I love to map episodes.
He said he sees employ Seattle genetics proprietary technology.
More than 10, he sees using our technology in clinical development by Us and our collaboration partners.
Lastly, in the fourth quarter of 2000.
The 19, we completed a license agreement with Beijing first collaboration with a company in China and increasingly important market for anti cancer therapies.
This included an upfront payment of $20 million and we are eligible for progress dependent milestones. This program recently entered in phase one clinical trial.
I'm proud of.
Our exceptional progress in 2019, we're diversifying our commercial portfolio and revenue drivers addressing meaningful unmet medical needs and investing across our portfolio to fuel future growth.
We're well positioned to continue transforming Seattle genetics into an important biotechnology company focused on helping cancer.
It's around the world.
His point I'll turn the call over time.
Skus or commercial activities and Todd will comment on our financial results at 2020 guidance after that Roger will discuss our clinical development activities.
Robin.
Thanks plate.
I'm excited to provide an update.
On our commercial activities.
That's centrus net sales in the U.S. and Canada were 166 million in the fourth quarter, an increase of 26% compared to the same quarter in 2018.
Full year sales were 628 million an increase of 32% over 2018.
This was driven by.
Yeah, our frontline indications in Hodgkin lymphoma and PTCL.
For your follow up data from the echelon one trial were presented at ash complement the value proposition that centrus offers patients.
Same clinical benefit eight plus ABT over ABVD enables meaningful discussions with physicians.
Looking to slow to adopt a bus ABT regimen.
Yes look forward to the find your data later this year.
For 2020, we are focused on continuing to promote et cetera et cetera is broad label now includes six indications.
Youre, describing the clear and durable advantage of 80, plus ABT into frontline setting.
I think for patients with stage, three and four Hodgkin lymphoma.
In frontline PTCL eight plus CHP is the standard of care for patients with LTL and we're working hard to drive use in additional cdthirty expressing sometimes while engaging with the soldiers lives to improve the reporting of Cdthirty.
These efforts we intend to.
New growing get centers franchise.
Now I'd like to transition to pensive, which was approved late in 2019.
The old genetics, and it's still a sales forces are active in the field.
And from physicians is very positive.
The number of accounts that have ordered pets.
These sites has exceeded.
Our expectations in January our first full month to watch.
We estimate that there were approximately 3200 accounts in the United States the trees metastatic bladder cancer patients and May order pets. So.
In the short period of time, we'd be in the market. Our representatives have already called on 1500 to these accounts.
[noise].
Also please with the rapid inclusion of pets and the NCCN treatment guidelines, there were significant unmet need static urothelial cancer, whose platinum chemotherapy and PD one PD one therapy. The team is focused on driving awareness and understanding about this important new treatment option.
Forward to updating you on our progress throughout.
To your.
Moving on to the cabinet commercial team is excited by the clinical data from her to climb and the positive reaction to our presentation at the San Antonio breast cancer Symposium in December.
Our sales leadership team is in place.
Hiring the U.S. salesforce.
We're attracting top sales.
Nipigon.
College experience.
Metastatic her two positive patients, especially those with brain metastasis needs new treatment options and her team eagerly awaits the approval.
In summary, the growing commercial team at Seattle Genetics is well positioned for transformative merger as we bring meaningful products to patients in areas of unmet need.
Now I'll turn it over the call to talk.
Right, Thanks, Robin and thanks, everyone for joining us on the call. This afternoon today I'll summarize our financial results for the fourth quarter and full year in 2019, and then I'll provide or financial outlook for 2020.
Revenues for $290 million in the fourth quarter of 2000.
It was 19 and $917 million for the full year.
It's included in set first net sales of $166 million in the fourth quarter and $628 million for the year.
That said was launched during the holiday.
Period at the end of the year and therefore only provided a modest contribution.
Sales.
Royalty revenues in the fourth quarter 2019 increased to $72 million compared to $25 million in the fourth quarter 2018.
This included a one time $40 million milestone from Takeda that was triggered by annual sales of at Suntrust exceeding 400.
Only dollars in its territory in 2019.
For the full year in 2019 royalty revenues were $138 million compared to $83 million a year ago.
Growth reflects sales sales milestone higher sales by indicated in 2019 and the royalty rate.
On the sales above 400 million, increasing said mid 20%.
Royalties from Roche on hold me also contributes into 2019 results.
Well aberration revenues were $51 million in the fourth quarter of 2019 and $150 million for the full year.
These revenues included $55 million and milestones from Takeda related take international approvals have been set person frontline Hodgkin lymphoma, FTC approval of Roche's Olivia.
In the initiation of Gs case phase three trial, whether he see utilizing our technology.
Finally, we recognize $20 million in upfront payments from Beijing upon entering into a product licensing agreement in the fourth quarter.
R&D expenses were $201 million into fourth quarter of 2019 and $719 million for the year.
Growth over 2018 or it's.
And higher investment across our late stage pipeline, most notably for pets, and catnip, which included the pivotal trials and led to the pets have approval and the cap the submissions.
She in a expenses were $115 million in the fourth quarter of 2019 and 370.
It really dollars for the full year.
They are both increases over 2018 and reflect commercialization efforts related to the et cetera is struggling indications and preparations for the launches of pets have been to cat, though.
We ended 2019 with $868 million in cash and investments.
In addition, we held approximately 163 building dollars in immunomedics common stock.
He shares or mark to market, which resulted in a noncash gain that contributed to investment income of $64 million for the fourth quarter and that led us to reporting net income as you saw in a press release.
Good afternoon.
Regarding our financial outlook for 2020, I'll begin with revenue guidance and there are three main components first we expect to set first net sales in the U.S. in Canada to be in the range of 675 to 700 drilling dollars at this time, we're not providing heads up guidance.
Second we expect royalty revenues to be in the range of $105 million to $115 million based primarily on anticipated sales growth of incept first by Takeda.
Third we expect revenues from collaboration and license agreements to be in the range of 30 million to $50 million.
Turning now to expenses, we expect R&D expenses to be in the range of $860 million to $950 million. This primarily reflects planned investment in past seven to cat, including several registrational trials as well as investments across our earlier stage portfolio.
It really has seen a expenses are expected to increase to arrange a $475 billion to $525 billion. This includes all your costs had said commercial infrastructure building, our talented commercial team and expanding our European capabilities.
We expect.
Set first cost of sales to be in the range of 5% to 6% of sales as a reminder, Seattle genetics book sales of pets of in the U.S. and we will record a stellar says 50% share of gross profit as a component of cost of sales.
Marketing and development expenses are also shared equally.
These are netted out in our S Union R&D expenses and have been reflected in our guidance.
So to wrap up we have both plans in 2020 and an opportunity to significantly expand the potential of our drugs to help patients and with that I'll turn the call over to Roger who will provide some of the specifics.
Thanks, Todd and good afternoon, everyone.
That's kinda describes tied to 19 was an exceptional yes.
Genetics and achieving our goal is bringing important new medicines to people with cats.
Hey, I will mostly focus my remarks on pets and to cast.
As we have ambitious plans like each of these exciting.
In Cogs.
I'll begin with pets.
Our first priority is evaluating this product across the continuum urothelial cancer.
There was three main components Trust strategy first on the FDA has accelerated approval program.
So I went to trial is required and we understand this all.
The global randomized phase three trial called <unk> three no one in metastatic urothelial cancer patients supersedes, the platinum containing regimen and a PD one PD one inhibitor.
We announced the study has completed enrollment of 609 patients.
I mean endpoint of east feel one.
Overall survival and in addition to serving as a confirmatory trial. It is intended to support clinical applications for approval.
Second our next goal is to move Petsense into first line metastatic urothelial cancer.
I saw the encouraging data from the combination of passive been keytruda, which will.
Updated next week at Heska G.
The reasons the initiation of phase three trial together with his tennyson, though.
He went and this combination with or without chemotherapy.
Enrollment is approximately 1100 patients and importantly, foods' first plant pensions, regardless eligibility.
PDL, one expression Oh nectin four expense.
I will evaluate dual primary endpoints progression free survival and okay.
And our goal is to evaluate passive and earliest stages as you know capsule beginning muscle invasive bladder cancer.
Tysons spiked treatments, including.
<unk>.
It was a high risk patients with metastatic disease.
We recently initiated clinical evaluation of pets monotherapy and the combination of passive had keytruda pipes surgery.
Non muscle invasive bladder cancer also represents future development oftentimes people petsense.
We are currently evaluating every penny.
These patients available therapies are difficult to tolerate and my style, resulting in a significant I mean.
You on Urothelial cancer, we believe the potential petsense extends to other cancer types.
Instead of US recently initiated a signal seeking.
Called easy to go to in a range of Nectin, four expressing solid tumors, including based non small cell lung head and neck gastric cancer.
I'll move on now just cazenove.
Oral tyrosine kinase inhibitor that Todd it's time to.
We were gratified by the enthusiastic reception.
On your best guess housing in December to the remarkable results from a how to climb.
Oh to contain it give us conviction.
Expand upon our clinical development program and hope to positive breast cancer and other her two positive capsize key areas of clinical focus includes.
Evaluate.
What's happening in a randomized phase three trial in combination with TD, one person's TTM when I'm done.
I think breast cancer.
This trial called her to climb to patients must have previously proceeds of texting and I'm trying to choose a map and he has event or metastatic setting and that's represented.
And seating first or second line treatment.
Second to cast live in combination with patent treatment is being evaluated a neoadjuvant breast cancer through the eyes by two trial.
In addition, we are considering a trial and agile from time to positive breast cancer.
Hi, good the initial data from 23.
It's treated with a combination of has to some happened to cabinet in metastatic colorectal cancer was very encouraging.
After consultation with the FDA, we've expanded the existing clinical trial called mountain, Yeah, 10 rolled up to 110 patients.
Third line metastatic disease.
Ultimately this trial is intended to.
Okay and potential accelerated approval.
We're also working on pads for confirmatory trials handling.
And lastly, we are planning tiles in her two positive solid tumors, including gastric cancer.
Thanks, Al time to antitrust, which was the subject of many important.
In Texas Ash annual meeting in December.
No just a full year progression free survival things if somebody asked on one trial.
Non Hodgkin lymphoma were presented and continued to show sustains clinically meaningful benefits in the central cost.
Oh the ABVD.
When you're obviously not side effects of Piedmont.
Some tended to improve a time most patients experiencing competing resolution.
Maybe recently the NCCN guidelines for both Hodgkin lymphoma, and cutaneous T cell lymphoma, whereby with a number of positive.
He's included elderly hotspot Hodgkin lymphoma relapsed.
Hi, Matt and CTCL.
Ongoing and planned clinical development program with in Texas.
Moods retreatments.
Houston patients.
Combination chemotherapy novel, five times, Hodgkin lymphoma combinations and relapse refractory diffuse large b cell.
Now I'll turn the call back to play.
Thanks, Roger before we open the line for your questions I want to recap key upcoming activities across our oncology portfolio.
Include first continue our strong pets have launched in the United States.
Tell us.
And advancing a broad development program, including a phase three trial in first line metastatic urothelial cancer seconds worked with us Yang and other regulatory agencies onto catnip approval and advancing its robust clinical development program.
Third continue to establish et cetera standard of care frontline.
Hodgkin lymphoma, and frontline PTCL and initiate additional clinical trials.
Fourth report topline results from the TV pivotal trial cervical cancer in first half of this year.
As we've highlighted today, we are executing on our bold vision, a future of Seattle genetics.
At this point, we'll open the line for Q, an operator, please open the call for questions.
Sorry, if.
If he would like to ask a question. Please pick up by pressing star one of your telephone keypad through using a speaker phone. Please make sure that your mute function is turned off to like ours, but I'm certainly try me.
Again.
Press Star one.
A question.
Our first question comes from.
Geoff Meacham with Bank of America.
Thanks, So much of the question just kinda couple.
So the first one is on the et cetera, Sky and just wanted to ask at a high level can you talk about your.
But patients for PTCL and maybe commercially what's been the trend in the field going into 2020.
And then on to cut into it seems like her to duration in the real World you for other therapies is different than just looking at PFS and so.
Are there any commercial commercial lessons to be learn from type curve or.
Others that can be leverage when you look to the two cutting that fund.
Thanks, guys.
Hey, So we'll start with the Centrus question, and it's our guidance and trends and stuff like that you know first of all I'd like to step back and put et cetera Synta contacts.
This is a.
And that continues to grow U.S.U.S. and internationally.
2019, with the first year that we had over a billion dollars global sales.
And this you know.
Really the last two years, we doubled the salesmen Centrus 2020 guidance.
Reflects a 7% to 11% growth over 2019 and that comes off of years, where we had 30% to 55% gross doubled sales in the last two years.
But in frontline Hodgkin, we have four year PFS data that we presented in December attach conference.
And later this year.
We expect a five year do that that's the gold standard the five year data.
In Hodgkin lymphoma in front line, so that should should be helpful Docs.
And PTCL I think you mentioned that that's still growing and we have opportunities to increase to use.
Especially a non LCL as es and to continue to look good.
But it is not the simplest.
Exercise to display.
Place decades old standard of care that are entrenched and we've been doing a great job and I won't continue to do that.
Importantly, with.
Et cetera, looking to the future thinking about guidance, we are continuing to do clinical trials and expanding our opportunities with these trials. Some of these opportunities are incremental but some of them are back.
We're looking at things.
Bcl.
Elderly Hodgkin lymphoma.
Treatment.
And there is early stage, one and two Hodgkin lymphoma, so a lot of different things and we're doing and like I said, some bigger opportunities like early stage Hodgkin lymphoma, where we're not in its half Hodgkin lymphoma front line at summer summer.
So overall Jeff.
Centrus is really terrific first product for Seattle genetics, and you know, we're so excited to be expanding our product pets have and looking into the future to cat.
No you asked about two cats event.
Duration and what lessons, we learned by that work or we're not giving guidance on that we're not at this point, saying how long we think patients will stay on.
Since I say tablets, it's taken twice a day.
It's got a Perry.
Profile efficacy.
And safety, we you know our data or really remarkable and I think we'll learn a little bit. How this can be used initially, but we have this brought development program and Rob.
Roger perhaps you want to talk a little bit about just what you think you see with duration abuse or what the.
Winners are as we look at it and different settings. Thanks Clay <unk> one of the one of the key aspects of to cast.
It's it's tolerability it has obviously very high efficacy.
Putting in price and the tests he is a unique population frankly.
If you studied in breast cancer and Tolerability is also can we.
We actually believe the tolerability with them all into plays into it.
That patients can stay on the drug protected periods of time.
That continues to surprise the two signaling access we have patients in the program anecdotally spin on the trucks, yes.
Oh I you know we are comfortable that extend.
He is quite achievable in the clinical trial itself based on published survival administration.
Uh huh.
And obviously as we move into other areas, where the Jewish stuff there may be dictated by.
Hey, wait wait comfortable I had two cats.
Used for long periods of time.
Alright. Thank you My next question will come from selling the Kim with Goldman Sachs.
[noise] caffeine and thanks for taking my question so with regard to your its interest 2020 guide can you just comment.
One way or accounting for such limited credit sat approximately 10% at the midpoint just given this over 30% growth. He saw last year and it's just conservatism or are there some dynamics at play here and then secondly on anything you can give us the carding B B really you know launch metrics or just.
You know, but quantiq plenty, Kate or qualitative feedback on as you're looking and launching pad sense.
Sure you know.
On et cetera, and our guidance, maybe time, you'll want to hop inherent and give some.
Ah commentary about test.
I don't want.
On a portrayed this sets us doing anything but providing the best we can do.
Not conservative or not anything I think that this is a brand that first got approved in 2011.
And we had been growing and growing and growing brands both in the U.S. and international is still growing but the growth has.
Slowed down the rate of growth has slowed down and.
But unlike a lot of brands that have been around four years.
This is Brad we're still investing in it. We're we have a lot of new findings and new data and we're really excited by that and you know.
Perhaps talk to comment on and Roger.
You can talk about some very recent additions to the NCCN, maybe we'll start that Roger you're talking about NCCN Todd.
Color. He wants upon this shot and so it is it is it is interesting it's amazing exit the answers thank god that continue to reflect.
Data that is that has put out in the public domain that is valuable.
No patients hossain tend to be a registration trial. The good example of that is the use of the Texas together with Opdivo in the relapse refractory Hodgkin lymphoma.
In a circumstance with little evidence has been raised from a two these are today space.
On the value.
With that.
In addition in populations have struggled to take combination therapies, such as such as older patients. Another novel ways of using a central switches to use it sequentially with chemotherapy and Texas followed by ABT has also made it into the guidelines and that actually represents.
Just older patients.
With that stage three four disease, putting includes a refined just stage earlier Hodgkin lymphoma.
Favorable teachers.
Oh the population.
And then and CTCL interestingly.
The ALCANZA trial, it's not directly we emphasized use and.
I'm extends T cell lymphoma, and there's an acknowledgment, which we know well that.
Cancer trial that was done with a cut point of 10%.
Got times now the snake.
The states, we know that patients have expression levels below 10% still do response, so the guidelines have acknowledged.
It's just that population is probably broader than just one.
And those NCCN guideline additions were this week. So this is brand new I think we're yesterday or the day before and so we're in new additions to three additions to the guidelines et cetera, I pod any additional color I guess.
Salveen I'd just comment that you know weve set for US is a big important drug that helps a lot of patients globally.
As clay mentioned were over $1 billion they'll globally.
We're very proud of that in the U.S. and Canada, we doubled sales.
Over the last two years, we had 32% growth in.
Putting 19 and that was 55% in 2018, so there's been a lot of a lot of growth and we're continuing to invest in trials that Roger mentioned that we think can give us growth in the future, but you know maybe 2019, there's a little bit of a catch to catch your breath here.
After what's been a pretty remarkable run.
I think it's ceteris provides an incredible base for us to build off of we've now got had separate prove we're looking to it to captive approval and you know we're in a very enviable position, where I've given our strength.
And what we have in front of as we can really invest aggressively.
And trying to drive pets of into Canada had been a really big important meaningful drugs that help patients globally. So I.
I think.
Scepticism is an important base to that story.
Thanks.
I'm going to your second question on early pets have Oh.
Uptake and what's going on there so what I first of all I want to say that we have not provided financial guidance and we're we're not going to yet, but we want to and we want to provide that as soon as possible opportunity, but we want to provide.
It would we have conviction and that way, we'll give you a meaningful.
Yes, and we really you know we were just approved towards the end this year and docs person were just organizing their patient. So you're the first full month really was in January so where we had sales and it's only now February.
And so, but but having said that we are incredibly pleased with the uptake we kind of made some internal predictions which are not.
So with conviction and you know pets have far exceeded our internal predictions. So so far we've been really happy with it.
Like.
Said, there's about 3200 accounts.
In the U.S. that can be called the caught up on an out of that about 20 850 accounts.
Predicts that the vast majority of sales. So those are the ones that were really focused on those 2800 out of a 3200 and we have.
And the first five weeks the seems to 1500 with US we are out there in full force.
Talking about this really important important drugs.
Same time that we had this full development plan.
Oh.
Turn it over the next.
Our next question yes.
Your next question will come from Kenyan <unk> with RBC capital markets.
Hi, Thanks for taking the questions. Its <unk> revenue was down slightly quarter over quarter can you, maybe just help us understand what's happening on a volume basis, and whether there's any impact from inventory or progress Tonight in Q4 and on the areas for that.
Such risks growth I was wondering from the teams conversations what needs to be seeing in the five year echelon one data to win over some of the prescribers who have been reluctant adopters of its interesting frontline Hodgkin.
And then secondly on.
<unk> I was wondering if you could elaborate a little bit on the decision to pursue et cetera spare.
After walking away from you.
Registrational trial, not invitation several years ago.
A quick follow up thank you.
Right.
As far as to revenue and gross to net and all that Todd you want to make a quick comment we've really discuss this a lot already.
Hey, look I guess I wouldn't.
Two hung up in quarterly variability you know they're different numbers to sales days I don't want to get into that but I'd say to specifically answer. Your question gross to net was fairly stable book of business was fairly stable coming into year end, you see a little bit of stocking I think it was probably comparable to what we saw.
A year ago. So yeah, I don't think that create as any significant variability.
You know so I think look at look at this year over year and there we had.
No we put up some pretty good numbers for the year.
Your second question was about et cetera, five year data and like what's important and.
What I would tell you is what's important is obviously that can efficacy and safety, but on the safety from right away. This has dope Leo myself.
That is a bad actor, having that as problematic drugs for a lot of patients.
You see some morbidity with it patient permanent long scarring and.
Permanent change in their life and they also have late problems that come up by taking blue license, so not taking Leo mice, and it's something that literally every doctor we've talked to all great is a good thing.
What were we are presenting his.
PFS.
You may recall that.
The first had our data come out with the one a while ago, we had an agreement with F. T. A at looking at something called modified PFS and we got a lot of hassle from.
People on why was it modified PFS and not regular PFS and all that so we.
Our data is strong whether its modified a regular pay assessment.
I think with a 33 year, we started using.
A regular PFS it because that's what everyone asked for and then the for your with regular PFS and the five year will be regular PFS and normal saying it was hey, you know well how are these different what is the differences were using what to standards and if you see you know any 567.
<unk> difference.
In the long term survival in five years, you could start saying.
It's a defined care, obviously, we all die of something but you know oncologist look at the five year progression free survival and then quite that was sure we're going to be the up to that so can you kind of increase the to find cure rate at five years.
Slide 567% whatever when is that we see in comparison to the your for data that we have at the same time is dope, we know bison, that's a win and so that's what we look at that you asked about do you know bcl.
And and et cetera said, what we're looking at perhaps Roger you want to talk about you know.
Fishing study, we want to do and what we're looking for in that side and that trial.
Well, thanks clay so.
Relapse seal Bcl has a meaningful number of some he'll be selling general and expressed CD funding. That's the first thing and we know that its interested back to we have Dana.
It's trading the.
No there isn't a program.
Sandra.
Beyond that we actually locations with a lower level of expression can also response. So we're planning on all come a trial and I will.
You show to account for the CDC expression, but we think and Centrus based on its its punsalan efficacy.
He and safety profile is a great option you know how good for patients who have failed therapy and off in the space around things like car T pieces and saw.
And so.
Knowledge and the fact is this was an attempt that was made.
Was it wasn't prosecutes Duncan.
Anyway diminishes the value of us taking its interest engines.
Actually we are excited.
I think a data that supports the trial has very strong.
You need to conduct a trial.
Optimistic, we maybe able to canton centrus or you know to appropriate to help patients we'd have to tell me. So.
Kevin you had it.
A quick follow up and let's face short one because there's a lot of other analysts.
No I appreciate the color lastly, I was just wondering if you could comment on what the next steps are and ongoing dispute resolution because you'd see some Q. Our work has a very much sided with your stance within that resolution. So just wondering next steps.
So.
We certainly.
Saw your report.
And you know it was very interesting we didn't know you're working on that so it was interesting.
For us to see that.
And your you know your conclusion was is similar to our conclusion that we have a very very good case.
You know what I would say to you is that legal issues.
Time and go through a process.
We we believed to should be an arbitration based on our.
2008 agreement with them, and we're making steps toward that and.
Publicly stated that they would rather have this in court, but at the corporate rule on him soon weather as well I should report, but other than that it's hard for me that keeps you inside guidance on this except for that we believe we have a very strong case in the history of Seattle checks to 22 years.
We have never.
Proactively gone out and done.
Hey, legal move like this we are not politics, just company, but protecting our IP when we see something that's obvious is something we will do everyday of the week. If we need to this is a first time, we've done it but we have to protect.
Yeah.
Company and to US this was a pretty obvious.
Thank you Sir our next question will come from entering your parents SPP Manley.
Hi, guys. Thanks for taking the questions.
I'm not going ask why that Centrus and put a lot of questions already obviously.
But can you give us some idea how the payer discussions are going to pad. So has there been any pushback on the price points that you chose that I'm do you have a question on three continents.
Sure.
I'll give a college turned over to Robyn.
I will tell you we it's been it's been going.
Great.
Really we just haven't had pushed back on this at all we think.
We did a very good job and pricing. This truck you know if you look at the world of.
Oncology drug prices, there's quite a lot of drugs.
That were priced very high above this.
And there are a number of drugs highs price below it but for the value.
I had said brings.
We take we put this in a very good spot.
Robin do you want to add any commentary, yes, absolutely so we'd be monitoring to see if there is any any issues that are rising with had seven what we've seen is really this.
There are.
No issues no pushback that we're seeing.
We have pets have a patient solutions in place. So if there are challenges that are an account comes across then.
Ways to help them out with that but the reality is that.
The lunch has been going very well and.
Very positive reception from physicians.
So it's a very high unmet need population.
Okay. Thanks.
And then hunky cotton Oh, when can we expect the mountain year to read out now that you've expanded that.
What do you think the borrows for.
Accelerated approval.
Thank you for asking the question on.
30, or so we put out data set were very strong I'd ask though and I would say was somewhat unexpected bye.
Yes, but there was a you know a lot of interest and not linear.
And no Roger and his team went to regulators had talked about this and we have an agreement that we would take that trial and expand debt.
And you know obviously everything is a review decision with regulators fund to take an existing trial and not restarting it just.
Span that out to 110 patients and bring it back to regulators any potential.
Truthful trial for registration granted we would need a confirmatory trial, but that's pretty incredible and we're super jazzed about that and so that's opening open and cranking and just adding onto a trial.
Ill add you know.
It is it as a corporate trial.
You know that we're running and I really think we have a great chance here, we're not looking for data that's better decision, you know something where retention in different things and combining them and wishing and hoping that we see something we haven't seen we've.
Okay, great data in her two positive colorectal carcinoma with a combination of hitting on outside of the sell any inside the cell with trust who's a map.
And and a ton of and so this is something that we think you know isn't really great opportunity I mean, this double hit on the outside and inside.
I really looks great. Roger do you want to add I'm, sorry, I went on about.
Do I do think one obviously can talk about timing, but from what I would say to you. This is now Seattle fixed costs. So.
The company and its resources behind.
We'll go.
And then relevant.
Yes, we can.
Hi.
Okay. One just quick follow up I guess.
That's on top of Percepta, and it's obviously, a combination and I guess in other indications other drugs. The FDA has sometimes.
Required some sort of controlled comparison, so I guess.
What do you think there's enough that's a good food, but they'd be willing to approve this on a single arm trial.
So Andy I, there they don't draw lines in the sand with us and write down numbers, but we we showed a 52%.
Response, right up the combination and in.
You know published reports on aren't using Herceptin alone I mean, you have something that's more like 15% response right.
And I and so you know.
There were like multiples above what we think.
Herceptin wouldn't thing.
And you know we did our trial, we do have monotherapy with Takotna. So we do know some of the components. So a lot of work is done and then with herceptin have modeled therapy of two continents in colorectal and we have to combination.
I think the.
Lenders have what they need and I.
Feels like that's what they've indicated to us.
So you know obviously until we get approval, we can't make promises but to go to regulators and have them say.
Can expand this ongoing trial.
And we'll look at the data and you're doing is pretty special just bring us.
For the same is pretty darn good I don't even think.
I don't even think we need to that's as good as we've had it doesn't happen exactly match and obviously you can't just go away, but we have room there.
Okay next question.
Our next question comes from Matthew Harrison with Morgan Stanley.
Certainly.
Okay, great. Thanks for taking my question I, just wanted to ask about TV because no one brought that up yet maybe you could just talk about.
What you think is the is the bar in that study and your confidence level around Matt when we get data. This here. Thanks.
Sure. Thank you for.
Thing about TV.
He is an interesting antibody drug conjugate fines to tissue factor and we're working on this week Jen Matt.
Hey, a partner of ours that we work very closely with.
We presented data on this in the past, but it was part of a unit dose.
And in phase one so it is very hard to know all of the factors on this data. So we've now are doing with our partners Genmab any bigger trial, a phase two trial with one ducks. So it is a.
A large expansion into phase two it is potentially register.
So we obviously have other trials that were working on combination trials and a variety of things that we're excited about with TV, but this is an important trial for us I think that from this potentially registrational phase II.
We need to see something that's meaningful I think we could start by putting into context.
To the last drug that was approved for relapse cervical cancer and that was Keytruda that was approved based on a 14, one 4% response rate for the duration of about a year.
And that was in.
They had to screen and that was in the PD one high.
PDL, one high I should say patients and so it wasn't even all the patient population for US we're looking at all patient population and we showed from our early data, which is not as big of a trial and not are potentially registered double phase II, we showed something in the 20% response.
Right.
<unk> for this dreaded.
Condition, you know if we're talking about lymphoma.
That's not something people get too excited about both for talking about relapse.
Cervical cancer, where there's very little hope it opportunity for patients and you have a drug that can give you substantively.
Hi response rate than the last truck that was approved.
Well just have to also watch for duration I think healthcare has not given us a line in the sad, but I would take that if we could get you know.
For that and we want as much as possible, we'd love to see something very long, but I think if we could get more than four or five.
Month duration or 456, I don't know something more something substantively with duration and something with a response rates with you know in a in the Twentys I think we have a really good shot now I will tell you that to me. That's just one okay I want to be able to.
Really help patients with relapsed cervical cancer, Okay and to me that's going to come from probably a combination study in the future. Yes, we want to get on the market with this as a single agent. Yes, we want to have another alternative for patients who have no other alternatives, but to me if we could get.
And then we could combine it with whether its chemotherapy or io therapy, or whatever and we should get up to potentially 30 40, 50% response rate in patients that literally have no options. That's what I'm looking to do so we're excited to get this into a drug and try to.
She wouldn't get disapproved. We're also excited to do even better by these actions.
Thank you Sir our next question will come from Cory Kasimov with JP Morgan.
Hey, good afternoon, guys. Thanks for taking the questions just have a two quick ones for you. So first of all regarding your ASCO GI you update next week for pets if how.
Mike This differ from what we saw at ESMO in terms is that just more patients or or just longer follow up and then the second question I have it just curious if the 2020 guide reflects any sort of planned build out for TV, assuming that trial reads out positive or is that not in there yet.
So the 2020 spend guide and TV and manufacturing I'll turn over to Todd in a moment I'll start with the ASCO Gi you and Petsense.
You know we are going to uptake and trial you know at ESMO trial was and it was interim data.
Weren't we did not have mature data.
Time, but we presented everything and it was.
Incredibly well received I would say we were one of the stars of ethanol and perhaps the Saar of as well, but that's a lot to say, but.
When we present the update of this trial ESCO do you.
I don't think we're going to disappoint anybody.
We have taught guidance, but then on your question with respect to TV in the guidance I mean manufacturing and stuff Yeah. I mean that that's built in to support the clinical trials that were working on there's some dosing work that we're still doing but we haven't yet fact, Doug a commercial built we want to get toward data and see how that looks and if we.
You know if we can hit the bar that clay just articulated in the last question then that will put us in a position to surface your thoughts on how we build that out.
Okay. Thank you guys.
Not that I hope, we have that issue that we need to really spend quickly on takotna meant.
You'd be manufacturing.
Okay.
Thank you. Our next question comes from Michael Smith with Guggenheim Securities.
Hey, guys. Thanks for taking my questions I had two pipeline questions one follow up on TV.
We've done some work there lots to already but I was just wondering.
If you can help us a little bit with understanding the initial market up a Canadian cervical cancer for example.
How many patients per year might be a tree and candidates should that TB tool for us exceed this year and then I had a follow up.
Well you know we're not at the point now were.
Giving guidance in the specificity that you are asking for what I will tell you is that they were about 13000 patients in United States that were diagnosed with cervical cancer and this is despite.
Having a vaccine called Gardasil, which is phenomenal vaccines, but not.
Everyone gets it and in fact.
When you look around the globe not only is it just on U.S., but a lot of other countries not everyone's getting it and in fact in some countries. It's not even in the formulary. This includes Japan, Brazil and other places so when you start looking how many patients.
Hi.
Around the globe are diagnosed last year was cervical cancer. It was 575000 that is a travesty, but and we would be very happy to have no business with TV in cervical cancer and packet up and go home. It's everyone was taking gardasil, but that's not the reality and the reality is.
At this is a horrible devastating disease and if you are diagnosed with it it's a desktops and we want to do something about it.
But like I said, we'd love to everyone in the globe had.
The vaccine and this disease was wiped out just it's not really where it is so when I tell you will not only was there over 13000.
Some people diagnose but over 4000 patients died and B U S.
Annually in the U.S. cervical cancer, so that could give you some idea of a number of patients that are diagnosed and die each year that I think we can address clearly as we get for do it as we get further along if we're going to be launched as we'll get more.
More detailed.
Assessment.
Great. Thanks, and then maybe one for Roger I regarding as Pat said and the bladder cancer opportunity I guess, there's been some news recently, we've seen some there aside from a out but then see a maintenance study and a front line metastatic patients and then.
So that was approved in the early stage setting and I was just wondering how what do you have for you is on how some of those.
Thanks might potentially affect the market opportunity for Pat have longer term.
Thanks, Chris Michael folks so yes, the ultimate.
Yep.
Had a readout using a maintenance approach one of the Jeff I'm trials, which is great that's great.
Trial designs.
Such if you look for example, the frontline.
Study that we were kinda conduct will include PFS, and though isn't outcome and we really see I understand I understand that maintenance.
Oh filed but that's limited to people you have some degree of disease control in the Frontend.
And to either in response or stable disease. It doesn't address the whole population I think we are much more excited to try and get pets have to the entire population of metastatic urothelial cancer. So I think that's that's our view and.
Obviously, we'll operation on the operationalize the trial with those endpoints in mind.
Great. Thank you.
Next question.
With Berenberg capital markets.
Hi can you hear me okay.
Yes.
Yes, so I.
That does you have a very robust babies platform. It correctly, you're very through acquisition hybrid application, while keeping a very successful one that would you revisit your M&A strategy and one follow up.
Sure. So we have a ongoing.
Tend to valuation for M&A. We are actively looking we believe we were looking for a few years before we.
Made the move on Cascadian and Ah you know.
And I look at a lot of things you could say that we we have done heck of a lot of diligence.
So first time, we really were making a move was when we tried to.
License it wasn't an acquisition it was a license of a second to snap koby came from Immunomedics and we went out at a time, where nobody in Wall Street really was looking at its fair share price was like three or $4 or share and.
We went out to do a deal which supports overturns because rationale that had nothing to do with Seattle genetics. It was more of the activity of the prior CEO of.
Medix, but we get keep our stock position top referred to it. We you know we made I think over $200 million or something on that stock position, which the courts did not rule on so we were able to.
Keep that which was part of our.
License deal that got overturned and yes, we would have and happy with that license deal if it got but it didn't but it shows you the power of our diligence and I give you that story because the next time you heard about our diligence.
With cascading, which is another company that was trading at low single digits.
And and Wall Street was not focused on it cascading was a company that started its life as bio Mira and then you had struggled to stay afloat and became Oncothyreon and then its struggled and it became Cascadian ad.
You know after 30 years or so being a company had this interesting product.
And it was very early and they really need at a company that was bigger was more power and a full regulatory and manufacturing and medical and everything staffed get this dawn right. So I'm very proud that we took this from a tiny little company.
Acquired the company with a you know a fair premium to their.
Shareholders admitted into something that this is now.
We can argue whether this is going to be a it's not approved yet so I can't fully argue that but a best in class or two tyrosine kinase and probably the type of tablets that see scientists at.
She S.K. who.
We're trying to make Tykerb you know couple of decades ago Revisioning, one that had high potency to inhibit tyrosine kinase and one that did not find teach you have receptor. So you could stay away from you toxicities associated with that so we're really excited what we did and.
You know to that and we do.
Great job and diligence and unfortunately, [noise] that means we turned out.
There's a lot out there that has a lot of height and it looks good initially, but then we dig deep and we take incredibly cheap and we find you know stuff that often that is.
Less savory and we don't go forward, but you can be sure that we're out there looking in full force and if we find something we are not going to be shy. We're gonna go.
Hard to do it and I'll remind you.
Todd can also comments if you have any questions when we decided to acquire.
Yes.
Canadian net debt, we went out and raised money for that acquisition not a penny more we raised for that acquisition and we were transparent and we said this is what we want to do and we can go and try to acquire company, that's very small or a little bit bigger I think we have a little bit more space to do it now.
[music].
Clearly, we're not going to buy a massive cutting but we'd have a little bit more space, because a bigger market cap at a little bit more you know bigger revenue et cetera, but if we decide to buy something.
You will be sure that we will go to wall Street, right away and say, here's what we want here's why we want it.
Why it fits in here's how much it's.
It's going to be and here's what we want to do financially. So we will be incredibly transparent the way we work with Cascade and we will go full force do it the minute we find something.
Great. Thanks, I saw that you just achieved up targeted price profit this quarter, how should we be thinking about.
It's been they like the off profitability going forward. Thank you.
Yeah, I say, thank you for the question.
The reason we had a profit in the fourth quarter was because of the mark to Mark market adjustment. We had on the IMMU shares that was 50, I think $50 billion to $54 billion.
As for the quarter written for the year, that's what resulted in the profitable quarter. So.
Please don't read more into it than that because it was the result of that.
We had a great quarter, certainly than we had a lot of milestone payments that were one off.
The Todd mentioned.
No we had three or four really.
Important payments that we got so quarter, you know was a great quarter Theres no doubt, we were thrilled with the corner and all the different revenue streams that we brought in but is we're not on ongoing activity when you pull out.
Mark to market.
We're not yet profitable, but thank you for bringing that up.
Next question.
Thank you. Our next question comes from Chad Messer Needham <unk> company.
Oh, great that good afternoon, and congratulations on a strong year.
So for for pad said that got approved.
Wait a bit ahead of it but due to date knew you anticipated that you were you were ready, but just wondering about catnip, especially given that it has real time oncology review.
When do you said you've got the senior sales leadership onboard for that when you think you need to be sort of fully.
Commercially ready for a to captive launch.
Sure. So I'll give you a little color on that Robin can talk about the amazingly strong progress, we're making with our sales staff on.
So you know we went ahead and we use RTL war for echelon two.
You could call and that one was a supplemental delay and an initiation of this high the program our to our at Ftn. That's you always things you could put into it with supplemental delays and we were able to from submission gain approval in 11 days I, we were told that as a record I.
I think its helps to and someone will obviously you said that maybe us on some other program. That's a supplemental be life and later afternoon added the ability to bringing a new chemical entity the to the arc to you our program having said that.
Since it's a new chemical entity.
Can you get a very rapid review, but.
Still need to have inspections of sites and all of the work that you need on the QC humane front with manufacturing so each talking to be an 11 days thing, but it can be very accelerated from a standard first approval and that has the potential that's why weren't involved in our more because of the.
Central for it to move forward.
No what the Fccs criterias for accepting things into Archie or I can say that echelon two had strong overall survival advantage.
We went in there with that.
A couple of that'll be a law and I can tell you want to two patents we have strong overall.
Survival advantage, so I think that.
I can't I can't tell you exactly what FJ would accept into our to our but the two datasets said they accepted from US are amongst the best we've had in the history of the company. So by that regard, maybe they're being you know picky and they should be for something to put a lot of effort to move forward fast.
So we're really excited with that and working with F. T I.
Keep in mind, we submitted that we haven't got passed the 60 days to where it is files, so that's coming up and not too distant future from where excepted to file. So that's the next thing you should hear from us about.
And two patent and but working hard with that I can tell you that it is they are putting a lot of effort and we are putting a lot of evident we communicate with them a lot.
Robin you want to talk about the sales staff and our readiness.
Me too.
He already let you know that Weve hired our sales leadership team.
One of the great things about.
But having the her to claim data.
Is that it's totally attracted attention from physicians and they're excited about the data, but also many talented sales reps and other commercial staff are excited about the data as well.
And so.
We have a very aggressive plan in terms of hiring we want to make sure that we are ready for.
For the approval whenever that may come.
And the Great news is that sale genetics already had a very strong reputation in terms of the commercial organization and so that's on top of the positive her to climb data that is very strong has meant that we have a lot of interest and the positions that we have opened across all of us.
So.
The real task for US right now is really just getting through a lot of interviews and lot of hiring decisions, but our number one standard just to make sure that we have very strong talented and focused together team.
And I'm very confident we'll be ready for lunch.
I don't remember exactly where we are but I do get updates periodically.
And then I know at the last uptake I got.
Two thirds of the sales staff are ready to onboard so just to let you know we're not sitting back waiting and that was a while ago. So we are really making big progress to having that sales staff at full force and getting it there.
Your next question.
Your next question.
He comes from Tina Lane with Barclays.
Thank you for taking my question just two very quick one.
My name is regarding pets savvy I know it is give any early but just wondering if you can give any color on any to reimbursement process time.
One question is regarding how to climb in field.
Oh I know you try to go.
For Booth first line and second line metastatic breast cancer.
What do you feel illumina assumption full herceptin naive patients and How's the study valley.
Okay. So let's start with headsets and if your question on average reimbursement.
It is too soon for us to really start getting into that when we had time with et cetera. We were able to say here is the standard patient and here's how many cycles of therapy and here's how much that's worth and you know what what they paid and all that in the gross to that everything we're able to really provide.
Details about the duration of therapy, and all that within central time, but we had to data we will do that likely for pets.
In the future, we just are not there yet to to.
The second question you asked was about her to climb owed to.
And so that's the second trial.
And not to confuse it with the original her to climb Roger can you talk a little bit about maybe a type of patients we have that could be first or second line.
You know maybe some of the inclusion and exclusion that's really all we could talk about at this point Uh huh.
A key component of the population is they have to have seen.
As to map and the Texas and that's the key.
Inclusion criteria.
<unk> under that circumstance provided those two drugs have administer whether it's in the neoadjuvant.
Edge event or metastatic session.
Hedging you can imagine.
They will clearly be patients.
Who will have seen those tried to do noting metastatic disease, so thats, great presenting frontline population.
Then they'll kidney patients who will have seen those in the metastatic setting and that represents the second life nice it's not possible to speculate what the proportion of patients suffer just pick on the trial.
Thanks for the question around.
Powering.
We can't disclose details, but I can just to show you how we've absolutely.
While appropriately based on the assumptions that we put into the study. So we expect if to cat plus TD and one is paid on T. and one alone will be able to clearly show that.
My question. My next question comes from Stephen Willey with Stifel.
Yes, thanks for taking the questions I'm just quickly on on on pads of.
Is it your expectation that you guys are gonna get slotted in behind the FGF par inhibitors in those patients that have.
Yes.
Our two three alterations and I guess when you gave your addressable patient numbers I.
I think in conjunction with the approval call.
That include a haircut for for those patients specifically as well.
And then I just have a quick.
A quick follow up on kind of.
I have quick answers.
The first two.
We do not know exactly.
What you're saying, but.
It is not our assumption that were behind you have to yet bar that is not the assumption, we're going to take and so in the calculation, we did not pull out any of those patients.
Okay, and then just don't forget about it but there was some discussion of San Antonia that.
There would be.
Some additional updates regarding the CNS subgroup data.
I guess.
Is there any kind of guided so you can provide as to when you might be able to present the thanks.
Yes, we are doing a lot of work in that regard. Thank you for the question it's.
Really exciting had the opportunity to actually look at you know cranial scans and start thinking about you know what what you're getting it is so few drugs have an impact on PFS in patients with brain Mets that this is one of the rare times you can actually look and say did you have a direct impact.
On the tumors and I would say, there's a decent chance that we will be presenting.
That type of work this year I don't want to say for sure on anything, but I would I think pretty strongly about that and you know obviously, we want to publish it as well, but we want to presented published at work and that's something we're very.
Very much looking forward to doing.
Thank you.
Our next question comes from RMB 6 million plan.
Great. Thanks for squeezing me, so I am just comparing the two proposals labels and the UN U.S. So you said, it's basically to prior.
Sure and tie her to treatment or sorry. This is about the catnip.
And he had to her to treatment.
Regimens and U.S. Its three so maybe can you talk about whether the two populations are significantly different or.
Whether it's a it's a function of just treatment differences between the two John.
Roger.
Sure. Thanks, Sandy for the question.
So the answer is that the labels.
Well populations, others say isn't the difference between what pre proposing labeled indication the U.S. suppose you.
We chose to simplify the indications I intend to you and that is our proposed indication.
I'll address that in a second based in part time feedback that we got from the biggest interaction with your opinions agency.
So just point out that these are proposed label is proposed syndications and final approved indication I will if we get approval will be determined in conjunction with the news.
Moving to sorties, but just to reiterate we do not this is not a different patient population this onto something a paradigm. It's just a choice about trying to simplify the language and indications.
And the key goes around wouldn't like agents as regimen.
Right got it and just a quick follow up in terms of the E.
The three or two study.
I guess you could argue the Seattle genetics in Mirth, probably understand that you see landscape. The best So obviously the goal is to get the combination out to patients as soon as possible just curious about your.
Thinking online.
Analyses in that trial.
Yes.
I would say right now that is a fantastic quest, but.
But it is not one that we're able to address today.
So keep that question in your head.
Is your comments in your thoughts on how.
We could do something quicker.
Other incident.
Three or two in another trial or whatever it's something that is under active discussion. So stay tuned we'll be back to you on that.
Got it cool thank you very much.
Hi, Thank you.
First question consulting trucking with Oppenheimer and company.
Hi.
Thanks, Congrats on the quarter and thanks for squeezing me in.
My first question just on TV, we've seen late last year data from Checkmate 358 phase won't be two trial, which you know kind of has comparable or our data of it be nivo in that cervical cancer setting.
Obviously given.
But youre phase one trial was was you know.
It was finding trial, so it might be lower bound but could you just couldn't contrasts like what what how could these two regimen compare especially maybe with a focus on side effects.
I don't.
No off the top I had the data from.
Trial, Roger can probably.
Set or discuss it you know what we what I'd point to is the last approved drugs for cervical cancer, which is keytruda up I don't remember the trial with from but it was.
Showed a 14% response rate and a decent duration.
We're trying to show as high response rate and a.
Situation as we can put these patients that have a huge unmet medical need Roger you want to ask but I play is making making the point so and that's that's the that's the history of what's been approved so since the scene for what it is we would expect to be measured against.
It's crazy.
Pitney Bowes Act has been so CAFTA and as a way fall.
You know that combination to move forward and semi cap. So that's that's great, but I think with we're pretty excited about about TV as close as such a high unmet need.
I think out there and it will stand by itself I'm told that they need to reference.
The combination immunotherapy claims.
Yeah, Good point and that May one last question.
Did you cheese 80, see making progress I guess in breast cancer, and I and I would assume it would take a share from tdm one.
Could we see a combination trial.
<unk> in the future.
I think that your question is whether the drug now refer to us and her to.
Daiichi at Astrazeneca could be a good combination partner with two catnip and hit on the outside of the cell with a very active antibody directed.
A drug conjugate inside of the cell with the very active and safe.
Two tyrosine kinase inhibitor is I think he fantastic trial that.
You know this whether we do it whether day, she doesn't or whether eight doctors do it independently as investigator sponsored trials.
It's going to happen in multiple ways. So I look forward to those data I think those two drugs should be tested together. It is the right medicine.
Thank you that concludes our question answer session and now I'd like to turn the call over speakers for closing remarks.
Hi, Thank you operator, and thanks, everybody for joining us this afternoon haven't goodnight.
Ladies and gentlemen, this concludes today's call. Thank you for your participation you may now disconnect.
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