Q2 2020 Seattle Genetics Inc Earnings Call
Please standby.
Good day and welcome to the Seattle Genetics second quarter 2020 financial results Conference call Today's conference is being recorded.
At this time I'd like to try to compensate for this picky Pinkston Vice President Investor Relations. Please go ahead.
[music].
Thank you operator, and good afternoon, everyone I'd like to welcome all due to Seattle Genetics second quarter 2020 financial results Conference call.
With me today or claims to go President and Chief Executive Officer, Chipped Wonky Executive Vice President commercial U.S., Todd Simpson's Chief Financial Officer, and Roger Dansby, Chief Medical Officer.
Accompanying today's conference call are supporting slides, which you'll find on our website in the investor section events and presentations page.
Following our prepared remarks, well open the lines for questions. We aim to keep this call to one hour. So absent you limit yourself to one question to get everyone an opportunity to participate in Q1 day during our call today.
Today's conference call will include forward looking statements regarding future or anticipated to them.
Including the Companys 2020 financial outlook anticipated product sales revenues cost and expenses.
Clinical and regulatory milestones, including data read outs regulatory submissions and approvals.
Actual results or developments may differ materially from those projected or implied in these forward looking statements.
Actors that may cause such a different include the difficulty in forecasting sales revenues and expenses.
Impacts related to the cobot 19, pandemic and the uncertainty associated with the pharmaceutical development and regulatory approval process more information about the risks and uncertainties faced by Seattle Genetics is contained under the caption risk factors included in the company's periodic reports filed with the securities and exchange condition, including.
The company's quarterly report on form 10-Q for the quarter ended March 31st 2020.
Now I'll turn the call over to clay.
Thank you Doug good afternoon, everyone. The past few quarters, it's been a period when mark any great for Seattle genetics across the business you know extended our commercial portfolio three drugs you previously Joby shambles, followed by the approval of Chicago [laughter] <unk>.
In the second quarter, you reported total revenues of 200 shouldn't need million dollars driven by record product shells, comprising et cetera.
These two new marketed products.
Sure you announced positive top line data.
North Korea showed enough Adobe and made strong progress across our pipeline, which can be development accomplishments I'm proud of the dedication of our true and you've pulled it back when making to address the unmet medical needs of cancer patients even in this time of the global pandemic.
Starting with the structures, we reported net sales of $160 billion in the second quarter <unk> 32 million hours for the first top 2020.
Based on progress you do need to your guidance full year, 2020, et cetera that sales range of $675 million to $700 million.
Okay that could choose secure additional approvals SPRIX actress expanding its availability issues globally.
Most recently the children plus chemotherapy is approved you felt like systemic anaplastic large cell lymphoma, and that's sectors was approved in China. So we watched what factory Hodgkin lymphoma and systemic ALCL.
We believe shovel. It stretches label expansion opportunities lie ahead, it's Roger will I want him. During his comments three note pad. So that's so in the U.S. was $57 million in second quarter and increased 66% in Q1.
We oh, there I stole it's continued to be pleased to be strong U.S. launch pad truck and its robust adoption for treatment of patients with metastatic urothelial cancer previously we see it PD one.
Or PD L. One inhibitor any platinum 'cause journey chemotherapy.
We're not providing full year 2020 guidance.
Up to waterfront Q2 $235 million.
Reflects our public expectations.
The strong initial launch a patch.
Oh gives you that pads that becomes freak out because you have treatment across the spectrum of U.S. Kildani cancer judiciously, where the bad Sea trials in first line data static.
Urothelial cancer and muscle invasive bladder cancer, primarily paired with Keytruda in collaboration with both Astellas and Merck.
We're also exploring cuts out in a range of Nectin four expressing solid tumors and believe that handset is well positioned to become an important global brands.
Our third and numerous commercial products is Chicago.
Rapidly approved by FDIC in mid April the metastatic hertwo positive breast cancers, including patients with brain metastasis.
We're very pleased to report second quarter, two Kaiser revenues of $16 million all your launch that employed virtual communication methods.
The S.P.H. project orders program Chicago is now also approved it's what's really Singapore, Canada and our submission for approval is under review in Australia.
More broadly be amazed currently reviewing our you marketing authorization application.
We look forward to bring it to cause it to patients throughout the world well continue to build or international infrastructure capabilities.
<unk> proxy recently joined us as.
Executive Vice President commercial International travel has deep experience in this area, including from Celgene, where he was president worldwide markets enjoys the most recently from Bristol Myers Squibb.
She will your commercial organization in Europe, and Oh W. Working together with chip, Rob who will continue to oversee the U.S. commercial organization.
[noise], both Htwo and chip served on the company's Executive Committee.
In addition to our commercial and regulatory progress.
That's a broad development program across her two positive cancers, which Roger will cover during his remarks.
Turning now to our pipeline in late Q2, we reported positive topline results from a pivotal trial. After so does not the dose or TB in women with recurring for metastatic cervical cancer.
We're developing TV in collaboration with John match and together, we plan to discuss these results would be up here.
We've received positive feedback from K wells on our topline results in which they exercise because significant unmet medical need.
Standard therapies for previously treated that a static cervical cancer generally result in long response rate and overall survival measured in months.
Plants present, either from the trial later this year.
Beyond me approved drugs et cetera, that's up and roche's pollo. They are TV data. Additionally, illustrate the growing importance of our bid dosing based antibody drug conjugates industries in upstream answer.
He was also know GSK is the last summer not the dose which uses our agency technology does closely related to the dose and recently, we see positive 12 to nothing you got boat.
Our growth plans for the company or broad working through expanded indications each of our commercial brands gout patients in need.
If youre future growth Seattle genetics is advancing more than a dozen early stage assets in clinical and preclinical development. These include novel agencies as well as immunotherapy agents and other targeted approaches to treating cancer.
There's much to share regarding our pipeline we plan to hold a virtual R&D day later in 2020 during which will provide more details on our expansive pipeline and our commitment to bring additional first in class. We're best in class therapies to patients can leave.
Stay tuned for more information.
Yes, I'll turn the call over to chip to discuss our commercial activities.
I will comment on our financial results and guidance after that Roger will discuss our clinical development activities.
Sure.
Thanks, Clay, we delivered strong results in the second quarter across the board <unk>.
You adapting our strategy <unk> <unk> at our reps worked diligently to accept that support our customers more teachings that definitely adjusted the market index increased digital and peer to peer speaker program.
Well, she would you need drugs and driving growth and established brand doublets whole World is a challenge that's a commercial team has missed out on this for each of the a flexible.
Well, that's first weekend the books on thought like DHL and PTC.
For the five year Pablo do.
Yes, a lot of one additional onto trials later this year.
Well I've your follow up well established standard when each stuck at the gate doable.
First in both of these frontline setting well driving for Belsher.
We're pleased with the continued strong okay, oh labeled indication workout so.
Just as strong as both academic like immediate shells and blackboard rate was robust.
We are focused on continuing to grow market share their labeled indication by increasing the number of patients who were treated EPL progressing like platinum containing chemotherapy and PD one PDL one.
We believe that patients are truly benefiting from his first in class caught that along with our souls partners. We look forward to building upon the early successes.
And finally, our latest products took place.
In the bus mostly older up much suffice to sales were $16 million.
We're pleased to what the label, which includes stuck at a later line metastatic patients with or without brain.
We're also pleased with you adopt it takes the among both giannini and after that it's positions.
In this virtual environment, you're a little high awareness at the time.
You'll be south or speaking good access to customers, we treat me I'll kick it to play so the favorable guidelines.
Rapid inclusion in the treatment pathways and strong JLL and teach outs.
Lastly, I look forward to partnering with although as we prepare for the actually watch it took place.
So I didn't talk with the company and for the commercial team as we need this important product available to patients now I'll turn the call over the top.
Great. Thanks trustee, thanks, everyone for joining your credit quality stuff.
Today, I'll summarize our financial results for the second quarter and year to date, and then you called it on our outlook for the remainder of 2014.
Total revenues for $278 million, and the second quarter and $513 million for the year to date in 2020.
Revenues for driven by product sales from our three oncology franchise, which totaled $240 million up 51% from last year.
Well to revenues were $31 million in the second quarter, it's $52 million for the year to date and 2020.
Great over 2018, primarily reflects sales with a checklist like Acadia and to a lesser degree royalties on sales and pull to be by Roche.
Collaboration revenues were $6 million in the second quarter and $22 million through the year to date and 2020. This compares to $36 million and $81 million respectively for the same period in 2018.
Results in 2019 reflected $38 million milestone she'd like to cater that were triggered by you and other Aro w. a pool of it separates the frontline Hodgkin lymphoma.
Cost of sales increased to $40 million in the second quarter and $78 million for the first six months to the year.
Cost of sales in the past to profit share to Upsells, which was $27 million in the second quarter and $43 million for the year to date.
In addition, beginning in the second quarter cost of sales now include the amortization of acquired technology related to the Cascadian acquisition.
The non cash component cost of sales that going forward will amount to approximately $6 million per quarter.
R&D expenses were $198 billion mid second quarter $393 for the first half the 2020.
These are increases over 2018, and primarily reflects increased investment across their pipeline that now includes 12 programs in clinical development.
Yes, Steve made expenses were $126 million in the second quarter and $248 billion. So the first half 2020 <unk>.
These are increases over 2018, reflecting commercialization of pensive into carissa and our European expansion.
We ended the second quarter with $896 million in cash and investments. This includes $175 million from the sale of equal, but the remaining portion of our immunomedics shares which contributed to investment income of $73 million in the second quarter.
I'll now turn more financial outlook for 2014.
Inspect the product sales as clay mentioned, we're maintaining our separate guidance of $675 billion to $700 billion and we're providing pennsaid guidance for the full year 2020 in the range of $250 million to $235 million.
Moving onto expenses, we expect 2020 coffee sales to be in a range of $185 million to $205 million as mentioned this now concludes product sales and profit share payment to it still looks for pets.
And the amortization of acquired technology related to Chicago.
Now that we're halfway through the year, we're refining our guidance for R&D expenses to a range of 822 $870 million and our guidance for Sta expense remains unchanged.
So with that I'll turn the call with Roger.
Thanks, Todd and good afternoon, everyone.
Today I'll focus on our two products tends to check size and it sets us as well as our late stage assets to such a met the docking I'll start. This pad says the 80 see directed against net console.
Given the ubiquitous expression of Nectin, four and Urothelial cancer. This continues to be the focus of our development program.
We can teach it enrollments are two pivotal trials in previously treated metastatic urothelial cancer earlier. This year. So just a second cohort of the easy to a one trial in patients who received the PD one PD one inhibitor and will not eligible for chicken was just clapping in the first on setting a positive outcome could supply.
Second indication for pets is and second the randomized phase three he be three one trial in patients who have received does a platinum containing regimen and a TV one all PD one inhibitor. The primary endpoint is overall survival and easy shield one is intended to say.
As it comes symmetry trial in the United States and supports global regulatory approvals.
Switching to assist line metastatic urothelial cancer, we have previously reported promising data combining kept pennsaid and Keytruda, which received FDA breakthrough therapy designation.
Based on these findings we are pursuing to pathways to address the unmet need and sank Lyme disease. First we are enrolling 160 patients randomized to receive either pad chip test keytruda well pads. It alone in cohort K., all the easy one or three trial.
Primary endpoint is objective response rate supported by the key secondary endpoints of duration of response.
This represents a potential accelerated approval opportunity insist planting in eligible patients.
Second we are enrolling the randomized phase GE V. two trial that is intended to support global registrations and now also says as a potential quite sandwiches in the United States together with that is still have some net talk knows we are reevaluating the need for tree experimental on.
In the either three or two trial.
This is due to the same Ted said Keytruda data and the evolving first line metastatic urothelial cancer landscape. The amended trial would focus on evaluating pets to test kits to the I pad chip catlin containing chemotherapy regimen.
Did you primary endpoints exhibition city and overall survival, we'll keep you posted as outstanding evolves.
In non metastatic messman days of data cancer. Most recently added pets if to the ongoing randomized phase three key that 95 trial.
This trial is insist class ineligible patients and what it says pets. It just keeps you, though given neoadjuvant lead times just the state to me and then post operatively as edge and then separately.
This study is being conducted object clinical trial agreements there Seattle genetics in a set us up providing pets is and mix continues to stand at operationalize the study.
This is meaningfully expedited development of the pet said Keytruda combination in this setting.
I'll now new launch ties up as clay just strides we have made rapid degen should progress in securing said when it tables based generally multiple data some of her to climb trial to say the develops to call. So we are initially focused industry. Her two positive therapeutic areas breast cancer colorectal cancer and.
Other gastrointestinal cancers.
And so to positive breast cancer, we are conducting a blinded randomized phase three trial called that you plan to the study is evaluating took ties in combination with Ketsana achieving one. This is kept sad learned in first and second line metastatic breast cancer, including patients with brain metastasis.
In addition to times a test kept side I will be compared to pet salary alone in the adjutant based cancer setting for patients at high risk and relax the phase three double blind randomized trial called something so to de will enroll approximately a thousand patients and is being conducted by U.S. Cooperative group Mr.
In Seattle genetics.
In Tenda rectal cancer imagined the upside is evaluations plaza in combination with test choosing that and third line patients with her two positive relapsed metastatic disease. This is intended to support a potential accelerated approval.
And do the other Gi cancers upside is now underway evaluation Chicago is a test test choosing lab and sell it definitely based chemotherapy insist on her two positive colon rectal gastric Sergio and gall bladder cancer.
In addition, we can't you initiated in the second line gastric cancer setting later this year.
Beyond these three areas. We're also planning to evaluate your Kaiser and had shouldn't Pearson to enter side cancers extensive compelling preclinical data. It's a CR last month Shang that to Kaiser select to be inhibits tumor growth and his team used in models additional novel combinations or trajectory Kaiser.
On the edge out cabs agents are also in Canada.
Moving on now to sepsis, we're studying several additional opportunities.
We recently initiated a randomized phase three trial in relapsed refractory diffuse large b cell lymphoma.
Well evaluate the combination of it sets us for tuck said and Revlimid business for Texas and ready to much alone in 400 patients.
Well its interest mono therapy is listed in NCCN treatment guidelines for relapsed CD 30 positive deal Bcl. This phase three trial is intended to support potential label expansion and will enroll patients regardless of cities. So do you expect and levels.
We also enrolling patients in the trial evaluating a checklist tests opdivo and chemotherapy in frontline Hodgkin lymphoma, we have added a cohorts of patients the stage, one or two hodgkin lymphoma under a technical collaboration with Bristol Myers Squibb, our goal is CIMB trade efficacy and reduced toxicity by limiting.
The number of chemotherapy components and the regimen.
Lastly, I tend to just doesn't have the day.
In late June reported positive topline results from the innovative cheerful trial evaluating single agent TV. In women is are paired omitted static cervical cancer, who had experienced disease progression on or after chemotherapy.
The data showed a 24% objective response rate with eight times three months median duration of response, the most common treatment related adverse events included alopecia, if he's Texas, nausea, conjunctivitis fatigue and dry it.
We will be discussing these results were 58 in consideration of a potential delays submission to support accelerated approval. We had not patches of Gen met the also advancing clinical trials of TV in other solid tumors, including ovarian and lung and hit Nick cancers and in combination with other agents used in the treatment of cervical cancer.
We believe there may be several opportunities for TV in tissue sector, especially in solid tumors and we are encouraged by the results from the innovative to a full study now I'll turn the call back over to play.
Thank you Roger I'm very pleased with our significant accomplishments this year and our teams have adopted to working in a difficult environment. We look forward to continued great progress at this point well open the line for acuity operator, please open the call for questions.
Banking, if you'd like to ask a question. Please take a lot pressing star wondering your telephone keypad, who are using a speaker phone. Please make sure you hear me function is turned out to like a signal to return to quickly. Once again that is star one if you'd like to ask a question.
Our first question for Michael Schmidt with Guggenheim. Please go ahead.
Hi, guys. Good afternoon, and congrats to add very successful second quarter I took I'd be one for Chegg regarding two kinds ship I was just wondering if he can provide a little bit more insights on how the initial launch is going and what you're seeing on the bar.
Good place in terms of its initial uptake obvious that seems some braves favorable seed batch compensations for example around the second line label are you, saying Oh, you've seen use there and how it's a drug being you know the station relative to some other novel agents such as for example, and hurt too.
Yeah, Michael Thank you for the question a chip can provide some color that was had a please keep in mind that are there early.
And and and they'll watch.
And are very pleased that pick up would you like to make some comments.
Absolutely. Thank you for the question.
It really is too early rewards to provide specifics, but we are happy with the level awareness Garcia with along with the uptake in both the academic settings.
Hard to below console label that we have this includes second later line, there's got to patients with outbreak.
And again, we're pleased to what we're saying with regards to optical wireless.
Okay.
Okay. Thank you.
Thank you we'll take our next question from Salveen Richter with Goldman Sachs.
Good afternoon, Thanks for taking my question.
So when you look at builds on late so far but the guidance would appear picture could you just how minimal factors cannot play in the second half of the Airbus is like.
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Sure. So thank you for the question and by the way we of course.
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We operator that there might have been some people that were the dropped off that got dropped off and can you actually I apologize.
Oh, good picture there that's been going on things that will happen.
Oh.
Carl.
Okay. So I apologize for that so go to your question on a guidance so it really doesn't watch.
Oh, that's up but we did want to provide some level of guidance. So far it's been a very strong.
Hi Tech, we work really hard at getting this drug to every patient need to working with the doctor and making sure that we could help patients isn't drugs.
No our guidance shows somewhere between 35 in a 55% growth rate.
The second half over the first half so a strong growth right.
Yes, just reported 66% growth.
The first quarter to second quarter, but that was the first launched at the second quarter and it's.
Certainly not unusual.
Later growth.
Begin to slow at large progressing yeah, we're walking to be able to see 66% growth quarter to quarter, but our guidance for show for a very strong healthy gross a third 50% over.
The first half year, and we're really pleased.
With what's going on.
Thank you.
Thank you we'll take our next question from Cory Kasimov with JP Morgan.
Hey, good afternoon, guys. Thanks for taking the question Clay I guess I just wanted to ask loved your your latest positive data TB and I'm curious at this point out that you have that in house, what are the gating factors to a b L. A filing.
Can you remind us of how you're thinking about kind of the commercial evolution here in terms of the initial opportunity you see this potentially growing into thank you.
Sure so as far as appeal I.
Once we had our data.
I'm pleased with our data this is the collaboration with doesn't happen work.
I'd be able to really help patients and no. Some of our data you know have yet to be put out there, but we're very proud of.
Moving in patients that have very little Oliver Chuck.
Yes, yes.
Response rates that are incredibly low and so I think.
When.
We had a chance to see our waterfall chart doesn't make sense and get really big positive.
So we are.
Actively working along and try to make sure that we connect with regulators and go towards a.
Submission, but we don't have I don't have information today for your because it would be not appropriate why that level of copper that confidential information until I had a discrete thing I'd say that's your could.
Certainly encouraged by our positive data and you certainly need to know that we're working very hard on the spread.
All the appropriate regulators.
No you ask another question about the commercial evolution, sorry, I'm looking at my notes here had no. This is something that we think that wraps refractory.
Cervical cancer market at the beginning or TV, you know TV is something that can absolutely be a use of the single agent, but also can be combined other agents.
It was our oh, well to really impacts of men patients, who can live relapsed metastatic cervical cancer and Oh, we pick the best way.
We'll be initially it for a single agent, but then it's a combination approaches and so we're certainly working loved that as we speak. In addition, we're working very hard on other cancer types. We have a basket trial that we have a substantial amount of data for we will be reporting that at some point in a few.
Sure and we don't we're expanding sometimes the coal as we speak so I hate to curb [laughter] tumor types.
Alright, great. Thank you.
[noise] Kimball here now from Kennen Mackay with RBC capital markets.
Hi, thanks, much for some of the question and that's the whole team and they really excellent operational quarter. One question on Chicago Bear the brunt sets or Aasco session really highlighted because ER doctors you only her two positive God that was highlighted and we tell you I was really suddenly opportunity usage in earlier lines of breast.
So to prevent a lots of true but to prevent the occurrence of green dot. So I wanted to understand what the initial launch, but then I missed the drug use studies at all in sort of second line metastatic which is allowable by the label. Thanks. So much from two that's again.
So you asked a couple of questions within your one question. So congratulations so I.
No worries as far as your uptick you know that's fantastic and they'll be chip can you give a little bit of color to the market dynamics and make some comments around when you turn it over two to Roger to talk about you know treaty and how we're looking at.
The treatment paradigms et cetera, so check can you perhaps.
Yes, absolutely. Thanks, so yeah, we we've we've seen a significant easy and regarding the case, a doctors have needed as a valuable addition to the the treatment tools that they have for these patients and again only promoting to the label, which does include second or later line patients with or without.
Great.
But again, we've been happy with the adoption that were so.
[noise] and I'll get some commentary debts.
Oh the data that was presented at ASCO is remarkable this is probably the largest stated that looking at patients with brain metastasis in his perspective Sachin then so.
The direct treatment effect on brain defensively, and really what represents a secondary prevention outcome, which is people who do not progress any sort of having had brain metastasis.
It's a control so I think Weve sun.
Good thing they that that to Kaiser is a very relevant treatment for patients with brain metastasis that'd be pointed out the label doesn't values in the things like that one would expect a drug like has decided to use we think we had competitive data again the her to climb dataset is is this.
Long as I think we would you ever expected to be with overall survival them and various other endpoints strongly that we have oh, we have a good value proposition to bring forward. A you know two to physicians and patients as they think about what treatment. They they should come for the in the middle that expense.
Thank you we'll take our next question from Chad Messer with Needham and company. Please go ahead.
A great congratulations on a on a good quarter and thanks for taking my question I was hoping to see it gets through innovative.
Finally, maybe a little bit more.
Details.
I know you're gets kind of a multi year I'm trying to give a lot of different combos as well as single agent you're looking at I believe it's the slides flashed bye.
I caught that that was relapse is as well as treatment naive.
Kinda just sort of confirm what you're trying to get out of that trial and it's one that we might be able to think of its confirmatory assuming you're allowed to file accelerated thank you.
Thanks, Chad watch or would you take that question.
Sure so.
It's a kits and essentially around cervical cancer and we are evaluating.
You know we are looking obviously too.
Understand where it's a potent had the dark may have a row, whether it's a single agent or in combination for example, with tend to live in that and other chemotherapy. The trial did not fit up as it comes up you called I would say, it's still a signal finding file workouts, both on a combination basis and on a therapy.
But then also schedule basis.
So whether the you know what they pass forward beyond the single agent TV data that we found the team to a full represents will cervical cancer.
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Thank you will not take our next question from General Wong with Barclays.
Uh huh.
Hi, This is Peter I'm, the chairman congratulations on another strong quarter I had a question regarding how sad and Mad study because they are the muscle invasive bladder cancer.
So you mentioned about 95 study because any line that's what role of core.
Page and say I really I think a warrant the there's a role.
And relevance.
You know it's not good bye.
Thank you very much.
Sure. Thank you for the question I know some basic bladder cancer, it's something a very big interest to us Roger can you make a specific compound.
On that.
Yeah. Thanks, So the question so.
We need the original design.
With that up in.
You want to see what signal finding cohorts, so we needed to understand.
TV monitor it looked like in the month in ways that up population that's focused something from eligible.
And we also needed to try and understand what a pad to keytruda combination could look like.
However, we have not strong activity with a tad says in later lines lots, we have very strong bedridden get offended disease with a combination of pets isn't true though.
It really was no no difficult leap of faith. So that's actually move that combination into a randomized trial. So that's part of my remarks I made the comment that this is really leapfrog the into a rapid development path a full pad.
Yeah.
Nothing but isn't that a cancer eligible space. So those two car will fulfill run we will generate the data.
Well ready basis, he moved into a phase three trial.
Great. Thank you very much.
Thank you will hear now from Andrew Burns with as VP Leerink. Please go ahead.
Thanks.
Congrats on the commercial execution across the board.
I was wondering if you guys could give some color on the pod started usage. We're hearing some box or is there a true them apart like I was wondering how extensive that is and what do you think that I'm. Since you have endorsement who do you have enough room at the time for reimbursement concerns.
Just.
One other one just I know, it's only in the launch.
Just to get some sense or how long pensions are staying on the drugs.
So thank you Andy for the questions. So first of all on the front line Fosco Trued up obviously, we can't make comments about you know off label use and so you know spontaneous adoption in that regard clearly our data.
With Keytruda, we're very powerful add that enabled us to speak with regulators and we were able to negotiate.
Not only a large confirmatory trial that global but a accelerator trial. That's a four with 150 patients with 75 patients with pets have at 75 patients with pets at plus Keytruda, which is well underway and we're excited about that.
As an opportunity in front line.
So what do you Roger before we go further and it's quite sure do you want to make any comments about had said that the frontline and how we're looking out to us.
Sure.
The front line the frontline space is dynamic it it's complex. They all biomarkers involves the Israel system eligible, but that's eligible patients.
But you have a coupon plan that we think we really are covering the water works one very carefully. So the first cobalt that play offline is out is all fastest path because it's a single arm trial were involved in that.
Since January and its plenty outcome is overall.
Get to response rate together with duration of response. So that's that's an outcome that we look forward to obviously.
We have the available that is a world of along the second piece, which is a much larger.
Randomized global trial, which is basically takes on all patients.
This eligible or not.
Very important component and really what what we plan to do now is it something file approach. So this is now going to be a pet she to the plan a full front line.
The cancer metastatic disease, regardless really old.
People capital I'm on for Bob PDL, one status.
So long.
You know where your second part of your question, Andy It's about staying on drug and all that that's a little early to be really making specific comments on that I think it behooves us too to look at the duration of therapy for a longer period of time to start making specific things that I will say that.
You know our goal with pets have is to be the standard of care. We then our label.
And we're well on the way to that and that's a big data. It's a big statement as hard as you know quantify that but you know with with what we've done with 66% increase in sales from the first quarter, which were very strong we're very proud of that we're getting it out there we're helping patients doctors.
We're relying on and we're hearing for them.
All this to standard of care. So that's something that's important for this.
You know where just so that you know as you think about patients staying on drug we have had no pushback from payer.
And that's a very strong acknowledgement toward the value proposition that pads have brings.
You know it is it is something that we're really proud of it should do you have any either.
Market dynamic comments I'm going to think about pets have and how it's being used.
Oh no clear, we're we're promoting before brought the level that we have them and together with a building I would echo the comments around the payer hoops, even though they're pushback whatsoever with very strong reimbursement of course.
Okay I appreciate it what what about the NCCN process I mean, I didn't color on how that's though.
You know, we we work obviously with NCCN, we if we have many many different NCCN listings for our different products.
Sometimes you get paid well guidelines and pathways placements and that's important.
And we certainly I've heard some oncologists who want to years.
Outside of in different ways, such as and you know.
Those who have received PD, one or PDR wasn't a car line setting that but there aren't eligible for platinum. So that's a little different and you've heard about some of that was a thought a common practice, but we feel we ever irrs [laughter] grew to talking to oncologists, we're trying to figure out everything that we possibly can I'm as far as they see I'm you know that it's really up to.
We don't really has no effect in this matter, but we provide lots of information for NCCN on any of our products. All the time. So that's something we look for.
Okay. Thanks, a lot of <unk> question as far as Roger.
We'll take our next question from jail, so the topic.
Oh, Hey, congrats on all the success and thank you for taking my question. The TV topline data were extremely impressive and I was curious about what we should look for when you present the detailed results from two or four later this year.
And then for the basket trial can you comment on which tumor types beyond cervical you're most optimistic about.
Sure. So you know I mentioned before that I was really proud of the TV topline data historically with metastatic cervical cancer.
I have drugs that are you know it the calc reset the objective response rate in these in this setting so really poor the most recent drug approval.
Metastatic cervical cancer with Keytruda and it's in the only a PD one high not an all patients and it was 14 waterfall percent response right and so you could just say from that how how difficult. It has to treat this very tough disease and I feel worse.
Were excited about that and maybe Roger you could talk a little bit about you know what's exciting about the top I did I mentioned earlier, the waterfall plots Olympic and look for on a trial and maybe you could talk about the leading types in the basket trial, we're looking at.
Yeah.
Sure so but play pointed out the historical benchmark that we would be measured against obviously there are different than that but you can use but the results of.
Think therapies or not great. So.
No no double digit upsell or thereabouts would be an expected outcome, probably quite a good outcome.
I think they're able to generate data in the close to mid 20% to sponsor. We think is an important did that and and as an important is your ability really.
Very excited by the median duration of response that we've been able to show.
Obviously, when we present the David will provide you know oh, the endpoint or the fund and putting some and the entire safety profile, but we think we have a good case to make it to the edge termination.
Whether they agree with that but we will we will certainly put our best foot forward. Because this is such an area of high unmet need.
We do see that TV to a forward so the validating for the disinfectant targets.
And so obviously wouldn't be working in other team though.
The possibility exists as it does with an agency tenfold in general, but do you might find another tomorrow to though.
Tends to be responsive, but in that that the trial, we have pancreatic cancer forget colorectal cancer, we have non small cell lung cancer, and we have head and neck cancer I think particularly interested in the latitude you find you know and obviously, we haven't put gains again today that but that would be though to co whatsoever.
And then we've already some TV already have active in ovarian cancer. So we have oh, a very can if it's going on and obviously, we haven't disclosed any of the information for the current data, but we are keeping TV in a broad fashion not only to the 10 and you know it's rolled in cervical cancer, but.
So its potential rogan those other two months.
Very helpful. Congrats and thanks for taking my question.
Thank you we'll take our next question from Jeff You can with Bank of America.
[noise] [noise] Hi, this is Greg Anderson on for Jeff. Thanks for taking the question.
So you raised your R&D expense guidance about 60 million.
While keeping everything else are the same.
Can you provide more color on you know what's programs and the pipeline. This is reflected in and if we should think about this increase moving into next year as well just trying to think through a prioritization of the pipeline then and profitability I'm moving forward as you've got all the time.
Yes, Greg This is Todd thanks for the question search I sort of you clearly we reduced our guy he's just a little bit of brought it down a little bit anyway.
I did have a mid year refinement, but you know when youre. Despite the incredible progress that we're making with expanding clinical trials and bringing new drugs in the clinic or the guidance update is reflecting some lower critical cross related to co bid.
Particularly in some of the harder good areas. We also are seeing decreases in you know traveling congresses and scientific meetings that of as I think everyone knows it's gone virtual.
We've had a very strong presence.
But you obviously no one is traveling and just changed its unique items that were seeing some more green best DNA.
Sort of counter balancing that was the.
Earlier today.
And watch up the kinds of your about four or so you for.
And your where there really building out our European capabilities.
Launch of the drug.
Starting next year.
Thank you.
Thank you we'll take our next question from Matthew Harrison with Morgan Stanley.
Hi, all a this is currently on for Matthew Thanks for taking a question I'll see you highlighted the CTG tea and body in your press release, but I just on that what do you think differentiates that versus other late state budgets and and you expect you need a collaboration part partner for PD, one or or similar combinations.
And you see a future there weve combinations with your pipeline and then just quickly on two case.
We hope to here a little bit more about what kind of patient feedback has been most positive to date thus far.
And what maybe initial thoughts from K wells are physicians have been in the brand that versus no that population. Thank you.
Sure.
I think I heard your first question and there was you were talking about combinations in the TV set it was that the correctly you said TV.
I think it was sorry for that.
Yeah, I still though.
TV.
So you know where we'll see.
We're excited about TV and going forward Roger would you like to discuss a little bit about the combination for thinking about.
Sure So pro pro TV.
We were generating data that we do think just to come back to sort of getting old but doesn't that form we have pretty strong scientific rationale.
Oh, combining the doesn't see together with a PD one PD one inhibitor based on what the doesn't that the deducting payload eventually inducing a human agenda cell death, which we think is an important mechanism, which one can increase the sort of you know the immune profile of the two most.
But not only getting the cancer cells, but you know, adding adding that sort of magic and boost as it relates to the immune system, we think its oh.
A lot about.
Combining with a PD one that's all they insist that obviously if there are reasons to combine with chemotherapy didn't kits that so that is what we are testing.
So as far as to Cai said the patient populations.
I will definitely treating both patients that have brain metastasis and those that do not so both are being treated and where we're out there in the community we're out there and major medical centers.
Anniversary, so it's been getting brought uptick and I'm sure you're hearing that as you talk to docs out there, but we're really pleased with what happened with Chicago, So far and we we look forward to having a great future with this exciting product and really helping patients.
Understood. Thank you and sorry, just to err on the first question what else would be possible touched base a year CTG Ti as a body, but you mentioned that that's just that you guys just initiated a phase one.
Oh, I'm, sorry pitch I'm, sorry, I teach you take sorry, I wasn't sure it's kind of hard at one of my fault, but yes absolutely.
Okay, well, so our TIGIT antibody utilizes our assay a technology.
And what that doesn't that results in a non fuel co slated yielded hydrant you one antibody. Okay. That's really important now the preclinical data set that assay a pitch it or actually a kid you take has potential differentiated profile versus other catch.
Yes.
And you know there I can get into that if you want to but it's very we're very excited with it the preclinical data is incredibly strong package.
And the phase one.
Data has already started and it's in a variety of different tumor. So yeah. We think this this compares very well with the the leaders now which are Roche and Merck.
And the work that they're doing into clinic.
It would take it though we think ours.
Come in and be a very very exciting product with differentiated activity.
Understood. Thank you.
Thank you and onto the next question from any highs with William Blair.
Oh, great congratulations on another spectacular quarter, and I hope everybody as well at that Seattle Seattle So.
My question has to deal with a phase we get relapsed refractory B L B field trial.
Could do you find that he sat business activity in that setting is there any sort of significant difference between 80 C and D. C. B subtype I remembered that they got let it might be more active in the agency type, though kind of in the context of combination is there.
And then role than strategy to enriched for maybe see population and you can optimum capture that effect.
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Okay. Thank you for a first of all saying that a quarter of a spectacular I think when you have 66% increasing pads have enough.
Hey, good first quarter with two Kaiser way past, where wall Street had thought we'd be no. We were very proud of that so thank you for your didn't work spectacular as far as treaty with et cetera, since he I'd be Seattle, and sub types or whatever I, but it turned out of the Roger.
Sure.
Thanks, Andy.
Well, we are we do have Ah, we do have a compendia listing in the thing for you. So all the pictures with deal Bcl.
And you are right. There is the gets in the past Revlimid is focused on one side, one upside, but yeah, but we are in broadening base.
And it's not only or sub five of them fun, but also from a cdthirty expression level perspective.
We believe that we have a good try to trading activity.
Thank you can see putting negative population, but standardized and there's lots of discussion one can have around why that maybe so the trial designs, we get an old commas and relapse refractory DLP CEO, combining a revlimid together with et cetera.
And we'll talk to them and we expect.
That's the population obviously from a public perspective, we'll evaluate that trial reads out before any potential pub goods, but better than others, but I think our expectation is we should get Pete and effect.
Of the combination that's sort of across the different parts of deal do you feel.
Great. Thank you feel like we're answering my question.
Thank you will hear next from George hardware with BMO capital markets.
Hi, Thanks for taking my question or not congratulations on great quarter. I was wondering if you could give us some insight into what's going on with two types. I mean, you guys. This is probably one of the person virtual launches ever.
You know granted yes, there was pretty great awareness, among which position community, but you know what what do you think is really kind of behind us. The this process what it would be but did you guys in doing that.
I'm, making this discipline this one stand out from all the others.
Oh, we are incredibly pleased with our label. It's a very very strong label that we got and you know maybe we get started out with Roger you could talk a little bit about the label and then maybe check you could talk about you know how we're doing this virtually.
Sure. So you know the eventually to Kaiser represents a best in class <unk> Oh.
It doesn't it doesn't arrive and then there's some debt central patients and the absence of other you know class molecules, but it does do live on the promise of what it small molecule and give it a can do.
I think we've had the good fortune of having a very prominent presentation at San Antonio at San Antonio Independent, where I think that data was well appreciate them father that up with his second presentation.
I'd ask again incredibly strong, though it's not that a favorable labels. So on the topic of sharing information at a.
Public for and sense of what are the label would recommend full potential useful to Kaiser I think we couldn't honestly have gotten to a bit a place that may have metal.
[noise] chip you'd like to touch base on market dynamics.
Absolutely GLEI, so I think the teams done a great job adapting to the worship location.
Customizable been receptive to that.
We also rapidly going from one product Oh, you're hopeful synergies on the commercial team was able to go out to clobbered lumped together across the board.
Customizable concerned about as well we've also begun a seasonally adoption will face to face our option.
Well, so I suppose.
We're working hard liquor was how else across all levels.
Great. Thanks, Thanks, again and congratulations.
Thanks, George Thank you will hear next from or Ren Benjamin with JMP Securities.
Hi, good afternoon, thanks for taking the questions and congratulations anywhere else quarter.
I guess my question is maybe regarding too high so I'd be reviewed in the you can you give us some color as to.
You know, how that's going well what do we might here regarding the you approval and I guess importantly, this new international cell source can we talk a little bit about that pilot looks over time and how we should be thinking about the rest of the world X U.S. and Oxy you.
Okay. Thanks for the crushing very much. So you know we first of all we have submitted in the project Orbis countries and that was the first thing that we've had to do you have to your program and that includes Switzerland, and Singapore, and Australia U.S., Canada. So we.
Our launched in one of the project Orbitz countries today, which is the U.S., but the others are coming we are approved and many of them and watch as you know on its way and these and so we're really excited about project or does that has you know we're preparing for watching there as far as you.
Where you know we are working very closely with regulators hair.
Hi, it's something we're right on top of it we announced the hiring of Tuomo Patsy who will read our you know X U.S. commercial organization Twaddle will report directly to me It said I'm Executive Committee and chip.
This call will report directly to me as well and cover the U.S. So at 21 chip well basically cover the globe for a commercial a team and both reported and that's what our executive Committee both have tremendous experience. So we're really excited to integrate.
Our thinking to make a global in our future plans and so when you look at grew up we're well on our way with the AMAG with what we're doing a we you know we hired country managers all over the place, Germany, France everywhere.
I'm getting ready for you know European launch for sure.
As you guys, we have met with any countries in Asia, especially the big countries to China, Japan, and some others and in Asia and generally you need to have small bridging studies and we've heard from these regulators and Asian countries and you know what we knew it exactly I mean, so we've already negotiated the exact.
I think studies and we're well on our way initiating those so we've made great progress in Europe, great progress and they shop.
And and with a project August actually you know have gotten quite a few approvals and getting ready to do those losses. So we're really thinking about your Kaiser in a strong why internationally.
Right and just if I could just follow up is there to significant expansion in terms of the international sales force with itself, how should we think it'd be thinking about the numbers of salespeople.
Yeah, we haven't given the specifics of how many salespeople, but we certainly are building a full force.
In the greater Europe region at this point a and so.
Well, we just haven't given specifics yet as we get closer to you know things will get more specifics and Todd will give some financial guidance to that but stay tuned for that that's coming.
Perfect. Thanks, again and congratulations.
Thank you I'll take a final question from choking since I don't know from Piper Sandler.
Hey, guys. Thanks for squeezing me in here glass on yet another solid quarter I'm just a question on E.D. too old to I know that trial just kicked off this past March but wondering if you could speak to the pace of environment, you're seeing whether that aided by the strength of E V and.
Data in bladder cancer, and then along these lines there any degree of dose finding in that trial and any consideration of looking at E.D. pembro in a basket tumor setting.
Sure to Roger I think right I think Roger should a drastic yeah. We don't normally talk about enrollment I could tell you are rolling I loved the Roger I talk a little bit about the trial and what we're thinking.
Yes sure so.
It's sort of on foot principles, because E V or Pat.
Active in bladder cancer and Nixon for expression is high on other too.
Because the real can but you know obviously you have to generate today, but the basket trials I could potentially give us another tool.
And that work is ongoing and obviously you know we can't talk in detail.
But from a again from a sort of footprint both of drug development 80, Tivo graces monotherapy, particularly and make the mine once you move into the align blending needs combinations and we think we've actually found a really strong combination partner.
The PD one inhibitors. So you know when could imagine that the basket tile does in fact, finding ignore it made particular tumor that we would develop it as a monotherapy and we would also look for combinations in the most obvious one to go to would be a combination with for example of PD one inhibitor.
Okay, great. Thanks.
Thank you and that does conclude our question answer session I'd like to turn the conference back over to Miss Pinkston for any additional closing remarks.
Okay. Thank you operator, and thanks, everybody for joining us this afternoon, staying healthy unsafe Tonight.
Thank you and that does conclude today's competent. Thank you for your participation you may now disconnect.
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