Q1 2020 Earnings Call
Good day and welcome to the Seattle Genetics first quarter 2020 financial results Conference call. Today's call is being recorded at this time I would like to turn the call the children to Miss Peggy Pinkston, Vice President Investor Relations. Please go ahead.
Thank you operator, and good afternoon, everyone I'd like to welcome all of you to Seattle Genetics first quarter 2020 conference call with me today, our claims to Gal, President and Chief Executive Officer Chip wrong Executive Vice President commercial taught Simpson, Chief Financial Officer, and Roger Danzy, Chief Medical Officer.
A couple during today's conference call are supporting slides, which are available on our website in the investor section events and presentations page.
Following our prepared remarks, we'll open the line for questions. We ask that you limit yourself to one question to ensure we are able to get to everybody during our call.
Today's conference call will include forward looking statements regarding future or anticipated events and results, including the company's 2020 financial outlook anticipated product sales revenues cost and expenses and timing to achieve potential 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.
Factors that may cause such a difference include the difficulty in forecasting sales revenues and expenses impacts related to the cold at 19 pandemic and the uncertainty associated with the pharmaceutical development and regulatory approval process.
For information about the risks and uncertainties space by Seattle Genetics is contained under the caption risk factors included in the Companys periodic reports filed with the Securities and Exchange Commission, including the Companys Annual report on form 10-K for the year ended December 31st 2019.
And now I'll turn the call over to clay.
Certain Josh good afternoon, everyone.
Yeah, well genetics is made remarkable progress over the past few months I've been extremely profitable accomplishments and the focus entirely attributable to during a period of significant global individual impact.
Well no commercial portfolio, which now includes three <unk>.
First in class was best in class medicines for cancer patients.
It's just which is an important daddy brand lymphoma, and we are investing in future growth opportunities.
So I was approved in late December for metastatic Urothelial cancer in today, you're pleased to about two strong first full quarter upsells.
And who your this month, we were huge approval to project for metastatic breast cancer four months ahead.
Due to gauge.
These are significant milestones and we remain excited.
Maybe expansion opportunities across the three programs as well as our moved you earlier stage pipeline.
I'll begin today with some comments on each of our PVA programs starting with its actress.
We're pleased to report its interest net sales of $164 million <unk> first quarter of 20, Twond Oh, 22%.
Quarter of 2018.
You want to be junior garbage, a full year 2020, and set yourself in the range of $675 million to $700 million.
Or partner Kinga continues to make global regulatory progress. Most recently huge MP adopted positive opinion recommending extension of the marketing muscle heard authorization, which was plus chemotherapy felt like she's done anaplastic large cell lymphoma.
Based on results from the national onto trials.
Looking forward to additional frontline Hodgkin compute you feel approvals Congress chose jewelry overtime.
We believe there are several additional opportunities food structures that are advancing ongoing and planned clinical trials in a range of settings.
The team we treatment you shouldn't patients who are uncertain for combination chemotherapy novel for one Hodgkin lymphoma combinations and relapsed refractory diffuse large b cell lymphoma.
We also expect 2.5 year progression free survival results later this year from both the echelon, one and echelon two trials.
These data further establish positive long term benefit of your proved et cetera, plus chemotherapy regimen bottom line stage, three and four Hodgkin lymphoma and in front line Cdthirty expressing.
Do you see all.
[noise] I'll move on now just pets.
Helping and commercialization in collaboration with the stalls outside of was approved in late December 2093 months ahead.
Right.
In its first full quarter on the market penetration net sales in U.S. with $34 million.
Pleased by the initial production patient reception to Petrobras as well as our commercial teams ability to shift quarter, two we booked tool engagement.
There are additional opportunity for pets at Leer lines and stages of lot of cancer.
The primary focus at this work is evaluating passive in combination with Keytruda.
In the past month, we've made important progress both first line metastatic urothelial cancer and muscle invasive bladder cancer that Roger will describe in more detail.
Looking beyond bladder cancer. The first patient was recently dosed you'd be too low to basket trial evaluating single when did you pass up in a range of selling too.
Our third and newest commercial product is to probably.
The brand name for two cabinet.
Very pleased with the strong label granted by SDK Chicago is approved for use in combination with trust to them up and keeps I'd be for patients with metastatic hertwo positive breast cancer, including patients with brain metastasis, who have received one little more prior answer I heard to based regimens in the metal.
Got it setting.
Dispositions regimen as an option for second line treatment.
Almost two weeks since the launch of two Kaiser which were conducting through virtual communication channels. We've been pleased by the reception from the breast cancer punitive to this new treatment option for patients.
Maximized the potential of to college.
Investing in a broad development program across her two positive cancers. In addition, we're prepared for European commercial office operations that have higher general managers in major European markets has a potential X few s. approvals of two Casa.
Turning now to our pipeline on the horizon with a clinical trial Readouts. Mr said about the don't TV, which we are developing and collaboration agenda.
Conducting a pivotal phase two seem alarm single agent trial women recurrent or metastatic cervical cancer, where there's no standard of care and outcomes are poor.
We expect to report topline results late this quarter or into the core.
Early stage clinical pipeline is robust includes 80 issues such as Libya choose them out.
S.G.M.C.V. two to eight and F G and H six.
So what should I be has just been submitted.
You can't late this year called S.G.N.C.D. 30 C.
This is a novel anti C.V. 30, A.B.C. the has the potential for enhanced activity and approved tolerability compared to et cetera.
Pre clinical data S.G.N.C.D. 30.
C will be presented along with several other abstracts on our research at the A.C.R. virtual annual meeting in June.
In addition to 80 sees we've made progress with novel immunotherapy agents in our early stage clinical pipeline. These include S.C.A.C. 40 and S.G.M.T.G.T.V.
Lastly, I want to provide an update on our dispute with Daiichi sankyo regarding ownership of certain technology used in the breast cancer drugs and hurt you.
And other product candidates.
According to our agreement this type of dispute shouldn't be resolved through arbitration.
<unk> has been trying to prevent are just moved from going to arbitration two actions in federal court.
On April 27th it was ruled that the disputes should be resolved in arbitration and that the arbitration process should move forward review this as a positive development.
Diverse commercial portfolio growing revenues and multiple programs that provide significant opportunities in a range of cancer types. We are when all positions to the future.
At this point I'll turn the call over to chip to discuss or commercial activities.
Todd will comment on our financial results.
After that Roger we'll discuss our clinical development activities.
<unk>.
Basically undecided update you on a commercial activities.
Chris net sales growth in the U.S. in Canada, and the first for what we're going by our front line indications and Hobson little though.
As plain mentioned, we look forward to the five year P.F.S. data later this year from the S. on one file five your data are and establish standard that we believe will resonate with some positions we've been sort of adopted suckers, plus A.B.D. and the front line set it.
When P.T.C.L. et cetera, so because of the standard of care for patients with L.C.L.
One of our areas for focused and Twentytwenty is to increase use an additional C.D. 30 expressing sub types.
Now I'd like to transition to pads.
In the first full quarter since launch net sales were $34 million.
We are very pleased with these earlier results and with a strong optics, particularly in the community setting.
We were still early and is it a lot and our goal passive as to maintain our strong momentum.
<unk> College, we're working hard to support our customers and to drive awareness and understanding of this important new treatment option for medicine agree with you will have patience seeking treatment after platinum and P.D., one or P.L. one syrupy.
And finally, our third product just a <unk>.
The commercial jingles ready for the rabbit approval.
Materials were complete.
Positioning patient websites for up to the data pool and the dedicated to type a sales force comprised of breast cancer specialists, so strange and ready.
Interested in the product is very high and our field sales seems a recording good virtual access to customers to <unk> is available or distribution networks and accounts are beginning door.
Forward to updating you on our progress in future calls now altering look all over the top.
Thanks, Chip and thanks to everyone for joining us on the call. This afternoon or financial results for the first quarter reflects significant progress across the business, including a strong first quarter of pen some sales.
Today I'll summarize our results for the first quarter and then comment on our outlook for the remainder of 2020.
Total revenues were $235 million in the first quarter of 2020.
What's included et cetera, <unk> sales of $164 million <unk> sales of $34 million. As a reminder, we record 100 per cent of 10, some sales in the U.S. under our code promote spells.
Royalty revenues in the first quarter of 2020 increase to $20 million compared to $16 million in the first quarter 2019.
This growth primarily reflects sales of et cetera, spike to cater and to a lesser degree now royalties on sale the poll a v. by Roach.
Collaboration revenues were $16 million in the first quarter of 2020 compared to $45 million in the first quarter of last year decrease in collaboration revenues is the result of a 30 million dollar milestone from to cater or and last year that was triggered by the approval of it's set for us in <unk> you for front line.
<unk>.
Cost of sales for the first quarter of 2020 increased the $29 million and now reflects both et cetera, as intensive including the pensive profit sharing stellus that was $16 million in the first quarter.
Beginning in the second quarter cost of sales will also reflect to Kaiser and will also include the noncash amortization of acquired in process are the that was part of the Cascadian acquisition.
We plan to provide further guidance on costs of sales on feature calls.
R.D. expenses were $195 million in the first quarter of 2020 girls over 2019 reflects higher investment across our pipeline.
G.N.A. expenses were $122 million in the first quarter of 2020.
Increase over 2019 reflects commercialization to efforts related to the launches a pad so into Kaiser.
We ended the first quarter with $800 million and cash and investments. In addition, we held approximately $104 million immunomedics common stock at the end of a quarter.
These shares or mark to market, which resulted in a noncash loss that contributed to an overall investment loss of $56 million for the first quarter.
We monetizer remaining portion of our investment in April which generated cache of $175 million.
We acquired this investment back in 2017 in our total game when also including prior year sales was $210 million.
Regarding our financial outlook for 2020 product sales will now include all three brands at this point, we're not providing guidance for pads or to hide and our et cetera guidance is unchanged from our expectations provided in February.
We expect R. and D. expenses to increase as trials of 10, seven to Kaiser ramp up S.G.N.A. expense growth in 2020 is primarily driven by the U.S. launches of both pads of into caused our guidance for R. and D.N.S.G.N.A. expenses remains unchanged.
Lastly, we continue to closely monitor the impact of code 19 or business. We've implemented a number of measures to protect the health and safety of our employees patients health and health care professionals, while also taking steps to advance our operations. These include efforts to mitigate disruptions <unk>.
Chain and continue clinical trial and commercial activities.
It's a date, we're pleased with the continuity of our business and in our ability to support the critical need of cancer patients for treatment. However, covert 19 has created a dynamic environment that may impact the company over time, we will keep investors updated as appropriate going forward.
That old now turn the call over to Roger.
Thanks talks and good afternoon, everyone I'm pleased to update you today, and I've clinical development and regulatory activities and the <unk> undertaking to maximize the to have a P.D. potentially allow programs.
I'll stop as pets, Oh, 80, C. directed against Nixon for which is ubiquitous he expressed in bladder cancer.
You know data from the <unk>. The E.V. two one trial supported approval of taxes in mid a static your theoretical cancer patients following treat them to the platinum containing regimen and the P.D., one or P.D.O. one inhibitor.
Yeah. This month, we computed enrollment in the second cohorts, which is evaluating patients. She received the P.D. one O.P. deal one inhibit that's who are not eligible <unk>.
We believe day, that's on the second <unk> 82, or one could potentially support a second indication for pets. It.
I think key activity <unk> is the ongoing randomized phase three E.V.C. one trial in advanced Urothelial cancer enrollment of 600 and.
608 patients was completed early this year and we are following passions for the time in point overall survival.
301 is intended to sort of isn't it confirmed that she study for easy to one and support global Reagan three applications for approval.
Had save in combination with Keytruda insists climate aesthetic European it'll can't say here's another <unk>.
At the ask a G.U. meeting in February we reported updated results from the easy one or three trial or 45 minutes static you really feel cancer patients who had previously untreated and ineligible for system since passing based chemotherapy you.
The objective response rate to 73 consent and meet injured rational response had not been reached median progression see survivor was 12 months and median over off the Bible was not reached the safety profile a pit consistent with individual components of the combination including ranch hypoglycemia peripheral neuropathy.
And immune mediated events.
These data supported breaks through therapy designation from the F.D.A. competitive in combination with <unk>. This is how sick into pets if P.G.
Based on discussion with the F.D.A.. We are pleased that easy one of three now has the potential to support and accelerated approval competitive and first line, so laughing and amicable mistake disease.
In January we added cold came to the trial, which will enroll 150 patients randomized <unk>, either <unk> plus keeps or the we'll pet sitting on the primary endpoint is objective response rate supported by Jewish and that response.
This accelerated pathway would be complementary to the randomize phase three <unk> three or two trial that is intended to support global registrations and now also says is that potential consenting to trial.
Today, we are announcing that we have treated the first patient in M.P. 302.
In this trial together within a status and we already evaluating the pets. If it keeps me the combination with or without chemotherapy compared to chemotherapy alone.
Hugin enrollment is 1095 patients and importantly includes all patients whether they are says pleasant eligible orange legible and irrespective of P.D.O. one expression.
The trials evaluating do upon the endpoints a progression pretty and to have a little survival.
Early bladder cancer, Seattle Genetics, Stellus and book recently completed a clinical trial agreement under which we will evaluate pets, if m. keytruda in muscle invasive cancer by adding to an ongoing <unk> phase three registrational trial.
Under this agreement, we had providing pets in it and look will continue to fund and operationalize the study.
This expedite the development of the pets, if keytruda combination in the fishing.
Now move onto two kinds I recently approved Oh tyrosine kinda isn't hit with the target so too.
We're very pleased by the F.T. is able to in the speed at which we received approval on the S.P. is real time on college, you will do we believe that the activities seen in her to climb trial.
Advices two kinds as a best in class that a two T.K.
At the ask a good show scientific program and late May we will present analyses on patients with <unk> in her to climb to further demonstrate the cheap and effective two kinds of observed in the brain.
The data, which was selected for an oral presentation will provide more insight into this aspect of the trial.
Are ongoing recovery efforts with her to climb include marketing applications that are currently under review in Switzerland, Singapore, Australia, and Canada. That's part of project all this and also in the U.
We also evaluating two kinds of in a randomized space cheat trial called fair to climb a two in combination with T.D.M. One. This is tedium one alone in met a static breast breast cancer, including patience and spraying the test to see.
In this trial patience must have previously received a tech, saying and tries to them and then the near <unk> <unk> <unk> that extending and that's represented population receiving first or second line treatment.
To climb to remains a coupons about two kinds of development program both to cause the N.T.D.N. One are important drugs for treating the third to positive breast cancer and they've heard to climb is oh two is successful it will support use of the combination in the first line anesthetic setting that's expand.
Beyond the current label.
In addition, given the demonstrated activity of two kinds of in pensions in Spain minutes to combination may also improve outcomes for these patients.
Enrollment in her to climb a two is ongoing with a target or 460 patients. The primary endpoints tuition free survival and Keith that can be important so overall survival empty if it's in patients with brain minutes.
Lastly onto Kaiser we previously outlined our plans and <unk> breast cancer and minutes that it caught a rifle cancer and does if it's a continuing trials and actually been breast cancer gastric cancer and hurt you can get them to amplified cancers in the planning phase.
Next I'll turn to Texas.
We recently expanded our technical collaboration with Bristol Myers clip to further we evaluate the combination of its interest ended up diva in an ongoing clinical trial. The focus of this new ethical beach with fits the combination plus chemotherapy in stage, one and two punched in them from this approach brings together to have the most active age.
<unk> our goal is to improve if it can see while reducing toxicity by limiting the chemotherapy components of religion them.
Now I'll turn the kohlbeck over to clay.
Thanks, Roger before we open the line for questions I want to recap he upcoming activities across oncology portfolio.
They include first continued to establish et cetera, It's a standard of care phone line, Hodgkin's lymphoma, and frontline P.T.C.L. and initiate additional clinical trials.
Second continue our strong pets have launched in U.S., we've just tell us and advanced Rod development program, including trials first line that a static and muscle invasive bladder cancer.
<unk> continued to launched two guys that following the recent F.D.A. approval and advance robust clinical development program and fourth report top on results from the T.V. 'cause little trial cervical cancer.
We look forward to continually or momentum into the remainder Oh dear.
At this point flew open the line computer operator, please open the call for questions.
I think yeah, if you would like to ask a question clean signal they pressing star one on the telephone keypad, if you're using a speaker phone, whose makes it again function if turned doctor like it could not tributary equipment.
Once again press start one to ask this question.
And you look I first question I'm traveling back difficult main text.
<unk> <unk> <unk>, you drag vegetables, <unk> and how should we think about the lunch capturing I'm afford and maybe you can just comment on that part as to whether that with the ball. It's a patient yeah. Thank you.
Yes, <unk>. Thank you very much for the question. We we're delighted with our first full quarter of pets and sales at $34 million and.
As I previously had mentioned on on the other calls that along the way that we keep shooting our expectation usually on you know we've mentioned that the uptake was good including in the community setting.
But you know at this point, it's really.
It's hard to really look and see whether sites and you can't really see that site, you're accumulating inventory, where that there was pent up demand or or things like that so it's it's very hard because she knew that right. Now you know this is a import huge.
Drugs for did he used it didn't really have a lot of good therapy and and so I think we're we're there and helping patients and language <unk> do you want to add anything to headset that that I didn't mention.
Oh sure Clay Yeah, we generally adults. He cites include significant <unk> significant inventory. This is kind of adjusted in time delivery model see gentleman whenever ordering they have a patient I think you're right in saying that this is this just represents an investment I think for bladder cancer, let this wasn't a retreat.
Lives out in the marketplace.
Thank you.
Okay care next question Fentiman, when it came with RBC capital markets.
Hey, thanks, so much for taking the cost <unk> screwed up on the wall credible pop up watch as well <unk> <unk>, it's like global pandemic ongoing huge huge comes up there so cut them, how can discuss a little bit slugs elsewhere with wondering what you're coming around impact.
Ah, it's better to me because I haven't done it seemed like it might have done a little bit impacted and.
March and then also it seems like the soaked about the doesn't beat out maybe got push back a little bit given this trial was fully involved I'm wondering if we should be thinking that maybe about subject pool longer.
Bothered responses the on off.
Yeah and collection from from the patient put it in that trial.
Not to include up again.
Thank you. So <unk> you know, we're really excited about et cetera, and it's a great job. It's helped get tens of thousands of patients and continues to the first time that this drug ever hit a billion dollars in sales globally would last year L.C. double.
Old over the past two years.
And <unk> quarter or from 2018 news, 22% up and the first quarter is always a little bit light with et cetera, and has been yearning you're out so I didn't look at the quarter over fears first quarter now having said that you know you didn't bring up coded 19, it certainly that <unk> you know.
It's something to look at whether there's you know a small number of patients that are unable to come in and get therapy for lymphoma is something that you know very well could be happening, it's really hard to know exactly but we're really you know we're really excited about our five year data coming out you know later this year and.
You know, it's something that you know, we we haven't choose your guidance from here. So I think that that's really really something important to look at now you you bring it recently snuck in the second question on T.V. about timing you know the most important thing with our data with T.V. isn't this is.
Potentially Register Bowl and you know we need to follow the data and follow the generation of the data and work with the third party you know that puts these type of you know blind good data together and and before we can present, this and and revealed a day.
So that's something that's ongoing we're working hard if they may very well com. This quarter. Okay. We're working towards trying to make that happen. We just put out that it may slip a little bit into the third quarter. Just in case. It does you know, but but we're working hard to get this done in as soon as.
Timeframe possible, so I wouldn't worry too much into it you know and and you know you'll you'll hear about it soon.
Thank you without any stupid.
Okay.
<unk> from Korea.
Cheeky marking.
Hey, Thanks for taking my question is Turner on for Cory onto paper, we heard from a few dock that pharmacy, okay could be a barrier to access for some patients.
Experience from other early administered products.
<unk> undertaking right now on the strong man.
<unk> I'm curious when you expect data from that you want to three study per patient better button, how it's cool okay.
Okay. You asked a question on the easy one three trial it was a little hard for me to here Roger did you capture the question.
Yeah, I did I did and thanks. Thanks.
<unk>.
And we do that first and then we'll go back to the two kinds of classroom with check.
Sure sure I can do that so the question was you know when we're we expect data from the one or three trial that that would lead to a potential you know approve against US patent eligible front line I made a static bladder cancer and the answer is you you know we we started the <unk> in January the.
The total number enrolled as 150, it's a randomizations us as pets, it mono therapy to pets plus keytruda.
The involvement just going as we expect we <unk>, we can't reveal the timing of of that but just to point out the response rates and duration of response to the to the to end points that we need. So we understand you know once we fully enrolled what that time in will look like but we just can't reveal that at this point.
Okay and chip can you comment on.
<unk> Turner had heard about two guys and co pay him any potential barrier. We worked very hard to make that not happen. So <unk> can you talk about our system for doing.
Sure, but through already established season secure programs, we will provide <unk> eligible commercially insured patients to help with in order to minimize out of pocket cost associated with the products.
Great. Thanks.
It'll take our next question <unk>.
Family.
Hey, all out this is called me at on from that actually taking a question. So it just doesn't pad. So can you elaborate a bit on your discussions with the F.D.A. accelerated approval in the front line. It I guess, how those conversations have have been going and how they made them back time on there and then just quickly on <unk> on cold with.
And on the Lodge, what sort of penetration of you guys been seeing busbar <unk>.
Matthew I'm, so sorry to ask you and I apologize for this multimedia way during this.
Microphone cut out just for a second went to go through your to question one more time.
Sure Yeah, yeah, sorry, it might be might as well. So could you just elaborate briefly on your discussions with the F.D.A. regarding outline accelerated approval for pads seven I guess, just how does it make going on and potentially timeline dependable and then could use provides some commentary on coding and the impact.
It adds to the pads of launch and then what sort of penetration that you you guys see and during the first quarter.
Okay. So first of all.
Roger just gave a an update on the front line work, we're doing 150 patients for the accelerator had sand approach and so he explained to chew arm it'd prepared remarks 75 patients future for 150 patients restarted be enrollment in January it's going it's going well.
We have not provided set time lines at this point, but you know our interaction with the F.D.A., whereas with strong and we put out a press release on it. We you know I think you know at the end to the date.
We've done this a lot yeah different drugs, we have.
Different approvals good drugs of labels and I think we're pretty good out there and we know what you could bring to the F.B.I., but at the end of the day. It's always reviewed decision you have to your looks at your data and make some decision based on the data. So we will work forward fast real be prepared and we'll bring it to the ASCII.
And as we get further into the trials, we usually provide time lines, but not yet as far as Kobe Bryant tuner had strep.
We can't rule out, but there wasn't an impact and corporate 19, it's impossible to rule about out we have two months in the field and then covered 19 hit and our sales people switch to a virtual sales force, which actually helped train up.
To be fully ready for two <unk> you know we have to drug getting approval for months apart. So, but you know the second drunk to <unk> purely a virtual as far as you know communications with with doctors et cetera, and you know and caregivers, but you know we're we've concept while we can't.
Rule it out at an idea that we're very pleased with the $34 million sales it'd be as we've gone out there and we really got to a lot of patience doctors are you do we drive we hear a really good things about we're certainly Polish on top so I'm going forward not only in the <unk> setting like.
But also in the first line and and other settings, and we have not provided a market penetration number on this as of yet you know these are things that we with deciding for future whether or not we would provide these type of guy.
And he said thank you.
Well take an expression from Michael Smith listed again.
Hey, guys. Thanks for taking my question sound Congrats on the two or take a launch here <unk>, maybe took a couple of Colorado on additional enabling opportunity.
Do you need to a one cool right to can you to set the first time, how bag that incremental additional opportunities mind. <unk>. Then you mentioned the a mark collaboration for makhoul invasive bladder cancer patients can needs help US you have what the parents would cost.
I could cook it okay.
Sure Roger gone ahead.
So thanks for the Christian so so as we've indicated we have enrolled code to come up to his his group of patients on the easy to one trial.
Who have.
<unk> eligible but have seen a P.D., one or P.D., a one inhibitor.
The smaller population than the broader population, which platinum eligible and have seen a P.D. One nevertheless, it's a meaningful it's a high inmate needed some meaningful population.
So I you know, where we're hopeful as the data matures and were able to you know give you a little bit more guidance from timing with completed enrollment. This is as his code one as was cut hooked one it's an overall response followed by generation of responsibility <unk>. So you know, we're hoping they'll get the results you know potentially later this year.
But I think as we get more clarity on the time, and we'll give you and I'm more guidance with regard to muscle invasive that accounts and we're very pleased as you know we have two cohorts running in either you Wanna Sweeney one looking at passive mono therapy and the other looking at pets. It together with Keytruda insists asking.
Legible patients with my seven days a bladder cancer.
And essentially buying it by being able to join a the mostly just traditional trial, there's sort of neat prompt potential to get an approval.
It's very important group of patients.
The endpoints as defined by a you know original negotiations between muck M.B.S.T.A. focus on things like that's what I'll just complete response and the Vantreese survival I think the details of of of how that file has been has been alternatives to accommodate pets and.
True that will become you know will become available.
You know three C.T. dot Gov or some other means in once they're available publicly I think we'll go into more detail for years, but that is an ongoing trial, which we are joining.
[noise] Ah great. Thanks for the information already appreciate and congrats again.
Oh.
Well take your next question just meet your must think of them there.
Hi, This is grandparents and aunts adjust specs are taking our question.
Just a big into the guidance a little more you know the fact that he maintained that across the board definitely showed some some confidence so just wondering what what impact or close at 19, you know is implied in your decision to maintain the guidance and and what what's so factors.
Are in play you know negative or positive that can be competence in that outlet you know both in terms of that cetera to as well as expensive that.
Oh.
Sure well all interested in centrist and Hello, Todd adjust the expenses. So you know it's interest is a is a great product been you know out there a prude too. It's 2011 six labels and you know helps patients you know it.
In many different ways, so doctors rely on not depend on it and patience you know benefit from it and I think that wouldn't be you know cobin first comes out and came out onto the scene. It was really hard I think through some docks and patience to really know exactly what to do we were all a little bit.
No stung by the the changes that happened so rapidly and so I think that initially it was it was not as clear, but it is really important for these patients continue getting therapy and and when they need therapy for cancer of getting therapy. You know it is really really important so I think that you know.
Over time, we we've learned a little bit more and learn how to stay safe and and wear masks and do other things and so I think that right now cancer patients you know or or you know getting therapy, and which is really important for cancer patients with life threatening even we see that you know strengthened.
And improving through the years, so I think staying with our guidance makes a lot of sense for us because there are patients I need therapy, and we think that you know largely they're going to be getting a therapy. Todd you want to talk about expenses.
You know first maybe start by saying that you know we have really as of management team tried to focus on this and keep your business interruption to an absolute minimum clay clay is right. You know when you look at what we're doing commercially what we're looking at from a clinical trial perspective, you know our our trials to cancer patients.
Are important then we have really done the best we can to keep the level disruption on our trials down now when you look at our our D. expenses in the first quarter you know a few manualize that we're a little bit below or annual guidance, but I would point out that we've got a whole bunch of trials that are sort of been.
<unk> and you know, we're trying to keep that going as best we canvas include the three or one the three or two in the one of three trials for T.V.
But to Kaiser combination trial with T.D.M., one the mountain near trial, you know the T.V. pivotal study we've got a lot of you know potentially registration studies on your way and we really done the best we can to you know keep moving forward is.
Fast as we can and and still doing it responsibly.
Oh, that's very helpful.
And especially <unk>.
Right. Thanks for taking my question and I, Let me add my congratulations on a.
Really strong first full quarter for per pads that I don't I don't think we expected you to get to this runway for for another few quarters at least.
My question is on.
Yeah for expression so in in Europe, the illegal cancer, you're not you're not a rolling any of these staffing study based on that.
Presumably because it's so ubiquitous but.
Are you collecting information on any that's been for expression and looking to see how it correlates. The response in in any other studies and.
Sorta, where I'm going you know maybe that becomes more important that you you look outside of your you'll you'll cancer just some other indications where it's not quite so ubiquitous and.
Kind of wondering how you were handling driving or you're back in your basket trial. Thanks.
Yeah, I'll I'll make a quick comment on <unk> talk about a lot of other factors, but very early on we were looking when these products started you know years ago and phase one you'd looked at H. scores, which tells you how much nothing for their s. and response rate.
Keep in mind that H. scores are is kind of a crude way to determine level of nothing for it's not 100% precise but it's pretty good it's and it's quick and it's readily available and it is ubiquitous in in a bladder cancer and so we we found pretty.
Early on that it was very hard to see a a correlation between the ages and ages for for the histology choose the response so.
In that regard, we do not need a diagnostic tool for in the not a static static and all that Roger Ah speech from there about any other thing in the basket trials et cetera.
Yeah, It's it's a great question so.
<unk> you know, we we look obviously for the highest expressing to M.S.N. So the basket trial easy to to as a group of Kansas breast lung hidden neck, gastric cancer, and so on which has high Nixon poor expression, but we always prepared so nixon for expressions always measured.
And if it if it turned out that actually a by Monica was relevant potentially in selecting patients who would respond I think we would be we won't be ready for that supposition those that that will not be the case. They were all components. For example, the doting 80 sees you know have bystander effect, so the drugs and it can.
Leak into a selling next door that isn't you know it doesn't mark with a particular with a particular by a mock up but so I'm going in premises, we will not need it but we will be prepared if we do.
Right. Thanks.
Let's take a next question from general I see.
Thank you for taking more questions Oh, no she parts of the question.
Regarding the topic squats I'm, just wondering like a strong a wonderful <unk>, Oh, Oh, Oh <unk>.
<unk> arbitration profit just wondering how long they they usually teach.
Multiple rounds.
<unk>.
So.
First because certainly pad said, we are not at this point planning to outline what percentages in academic.
Settings in what percentages in community Fat is I think in prepared remarks.
Chip mentioned that you know a fair amount of the news is coming from community settings, which we're delighted with so Ah right now we see no script coming out of those academic and community setting and we're very pleased with the uptake and yeah. We look forward to having a great year providing.
Pads have to patients you need to end to the doctors and supporting the documents as they use pet seven impatience that can really benefit from this exciting drugs. So that's something we're going to continue maybe in the future will be in a position to discuss academic community settings, but it's it's entirely too soon to speculate think about that.
As far as the litigation you actually believe you asked a question about.
What we meant what we've discussed me died she said I feel is that correct. You know did you ask that yes, yes. So the <unk> arbitration process, just wondering <unk> well now so you know what that the multiple ones.
The court process.
Just one <unk> <unk> you know certain time frame should we expect them.
<unk>.
Okay. So we are not guiding them to any specific time frame for that I. Appreciate the question very much. We're pleased that the the ruling wants to go forward in arbitration keeping fine. That's the deal. We good basically said that if there was an issue like what has come up.
That the correct approach and the right legal pathway forward based on the deal that we had we had thanks you think it wants to go through arbitration.
And we believe that our case is very strong.
To be mentioned is publicly before.
You know we believe.
That they used to our technology and they made improvements which was completely spelled out in the agreement.
Two there <unk> to to the product.
And we believe we are correct in reading this case forward and protecting our I.P. as appropriate. So we're we feel very strong about that going forward in.
In arbitration is it's a more efficient and rapid path fall into a resolution rather than bringing it to court case.
And so we're we're very pleased that is is going through arbitration. That's now started.
And but other than that it's a pen illegal matter and we really can't make comments.
Mm.
Okay. Thank you.
[noise], referring expression from joke <unk> I personally.
The guys that thanks for taking my question can't congratulate us nice stuff pets, a quarter just one question around it and and maybe just to try and give us a sense of the trajectory moving forward. One thing we had heard even prior to call that is that with pets in the rural setting some physicians felt they had flexibility and how they don't stick given its though step three weeks that.
Toward some balance advocacy with the Tolerability, just wondering if you're sort of seeing that and whether you expect that to make and pick up in light of the current environment to sort of make minimize patient. That's thanks, and then he sent to I'm duration of treatment don't realize it's early here.
So you know Joe I.
We haven't really seen what you're talking about I I could turn it over the Roger well you know to comment honestly, we haven't seen doctors flexi into some other schedule I mean, we we we've done our you have our schedules three weeks on in one we we've got the holiday drive holiday and that's our schedule you know the duration also.
We presented that with all of our data and I you know and so we have some from data under ration that we're very proud of and it's it's exciting Grady drug I mean, Rogers or anything you want to add to that.
Yeah sure. So so you know I think when you're getting to cancer medicine, and a disease like that a cancer, which can be devastate is devastating pensions are very symptomatic of the demand to get to treat them through the plan is high.
But the initial sort of on sort of covered it may it may have taken some time phone calling for next to work out how to manage through what anew schedule could look like and how to get patients treatment. So most of the focus that I think we're aware of is that the tronics focus on giving treatment. They they may they may struggle with off treatment.
And so on but getting the treatment is paramount.
Okay. Thanks for taking my question.
[noise] like I'm afraid.
<unk>, alright, but maybe.
Six and one yeah. My current remotes on the strong launch you guys <unk> two number and we thought that was a great launch yesterday.
She wanted to get some more color on pads abusive truly just one question, but three parts.
Shouldn't we think of good a beep as do driven by more advanced patients then you'll eventually get I don't see the other launches that kind of water to the gate and then the duration of D.C. for the early patience drops off.
Those are more advanced just trying to see that can be the case here.
And then.
Can you guys give it seven in color or are you seeing usage of pad. So good keytruda.
And then the last part is are you getting patients that have the <unk>.
And it's so thank you for your questions.
And and congratulations to you on putting on three questions into one area.
<unk>.
So yeah ours the advanced patients go your comments on whether we see a lot of advanced patients and we'll see a fall off and all that stuff.
That it was not where we feel we are we feel this is being used broadly and will continue to be wildly. Yeah. We have a lot and there's a lot of excitement for this job going forward and I think for anybody that has you know metastatic lot of cancer you know according to the label this treats anybody whether you're advanced.
Advanced less advanced keep in mind that most patients with a lot of cancer to some extent are advanced into bad disease, and but you know whether they're there earlier in that cycle or later in the cycle all of them can benefit and I don't I I really can't make comments that were just seeing one type of patient I don't think that's happening.
As far as in combination with came true to you know we're we we loved our data are gaining a spectacular we've gotten which is why we start in a global trial to do to look for front line, which is also why we went to F.T.A. early to say.
Isn't an expedited pathway to get a first line in combination with kids should so we're doing both the full global trial as well as doing the asked the guy that trial and we pass out and you know as far as whether anybody if using.
Pets out in combination with <unk>, we we can't make any comments on that that's not certainly not something got were out they're promoting for all we have clinical trials open right. Now I think that you know we're encouraging people to sign up for trials to do that and as far as the last question on S.U.S. biomarker were very aware of that you know you know.
<unk>, it's not it's not something that we're focused on though I mean, that's a small sub section a lot of cancer. You know, we basically have no <unk>. There's no diagnostic tool. We can use everybody. So you know we treating everyone I can I I should say and we're so we're you know we're we're we're looking at.
Really just helping out as many pensions as we possibly can and working with the doctors.
Their their therapy decisions.
Right. Thank you very much quiet.
Okay next question <unk> <unk>.
Yeah electric taken the question and you got some more on the cops would launch just a couple of quick ones was was.
Maybe thinking was talk.
A little bit about C.D. 30.
In terms of what's.
What's being used there to drive <unk> colored, though that was reference a little bit remarks is that you that.
More stable luger better different payload and then just curious regarding your publication plans. If there's any in the works for the E.D.U. want all three data in terms of the preliminary results were we to as far thanks.
I'm sure I'll I'll I'll answer the C.D. 30, she question and then Roger King Oh Pine on maybe one or three plans.
Publications presentations whatever.
It's easy to see we <unk>, we we decided that it was important to try to continue to innovate and continue to make as best of drugs as we can for cancer patients and she d. 30 to target you know a heck of a lot about.
That means we as pets.
Ears, I think <unk> no one else [laughter] companies, if not the top companies will be about 30, it's infinity hair.
And so I think that even though it's really important need to think about can continue to get better and treat patients better you know what's interesting is a phenomenal drug, but but to try to improve outcomes for patients with C.D. 30 malignancy is is important for us. So we we set out a few years.
Ago.
Trying to say how can we make a you know a drug that can even give patients even better outcomes. Then what's already a really good dropping et cetera, and you know it was hard I mean, we we made a lot of different versions and just couldn't get any better than et cetera is for you.
Which tells you a lot about a centrist and how good of a drug it is so which C.D. 30, C. you know what I would say is it's different different lakers different pay a little different ways. It's gonna work different ways into combined with things. So you know in in the laboratory setting in an animal models of cancer.
No. We're we're really excited with it in the clinic, whether this will prove to be better then it's actress or gift for instance, actress with different characteristics. We don't know yet, but we're excited to bring this forward and see how much. We can you know work toward helping patients. So that's really what that's about Roger if you want to talk about.
Do you want a three implants.
Sure.
Yep. So it's it's a great Christian and it's under consideration because you know as you know the results were really quite remarkable and you know we think that it could potentially be worthy of a publication.
But I don't think just final decision has been made but obviously, we'll update your you know if we make a cool.
Alright.
<unk>.
Well take our next question some judge primary female capital Mike.
Yeah.
Hi, good afternoon, and congratulations on pads that it's fantastic to see I actually have the question about et cetera, and are quite you mention that there's going to be since five year follow up data.
<unk> do you expect that <unk> <unk> practitioners and then so how how do you see that.
No. Thank you for the question George you know, it's a it's a good question.
When we started and got our first approval in front line Hodgkin's lymphoma, you know a lot of docks solve it there and then they saw it with you know two years worth of data and the data were were strong but they said no. This is a disease and you know how to treat for decades, they were using a D.V.D. and it had a lot of data.
And the docks, you know remark to us into five your data was gold standard for this and you know they they really wanted to see the five your data and really know what durable long term and you know and they call cure ready no cure I mean, you know you all died Sunday or something but if you're fine.
Years out and you have no evidence of disease, you know doctors will talk to their patients and they say you know you are you know you're disease free you weren't technically cured of your cancer, because we had no additives five years ago. So this is defined cure for sure, but they they've always had to us that the five year number was you know.
And the gold standard and I think that you know for anybody that you know is still you know on the fence or not considering that I think the the five your data absolutely it could be interesting whether it'll be a a mad rush or something we're not according to that George but I think it's certainly could be important the other thing is especially during these <unk>.
We're living in you know, having five year data.
In regimented without the we have mindset you know it's <unk>. It's important we have ice and causes lung scar and gives you you know respiratory distress and for somebody you know to have hotchkin lymphoma, which is in many circumstances, a curable disease by the definition I said.
I have to give them some pretty severe lung toxicity I would not want to patients have that and then be exposed to cope with computers. It could be much much worse because of their you know lungs scarring that you get an respiratory distress you get with my son, So having this alternative that not.
Only is better you have a higher rate.
You know, we we presented the for your data in a for your data so far a higher rate of disease free survival five around 6% to 7% over a D.V.D. and without the the lungs color ended up leaving my son I think is an important thing to think about in this told that era that we are are are working through and having the five your data wouldn't leave.
It'd be better.
Yeah.
And then finally.
<unk> talk a little bit about what the two kites that presentation will be <unk> discussing it ASKO in more detail.
Oh, we can't tell you the whole presentation, because that's that's food did he ask a virtual meeting, but Roger can you get a little foreshadowing.
Sure so.
As as the Hood to climb was designed <unk> and as it was presented we focused on.
No the main points, which are progressing for survival than the overall population overall survival them intuition free survival in patients with brain metastasis, but important questions and that and that's the framework under which to understand the value in the benefits of patients, but important questions <unk> Toby and so in the by interrogating the data and fun.
Cussing really on the outcome in in in the brain and so and so we've we've done you know those analyses and we've put together what we think is a a coherent story to explain.
You know more clearly what the brain specific outcomes will look like and that's what we hope will be a value to to everyone and when it gets preventative esko.
Hmm, Okay. Thanks very much.
Yeah.
I think our next question from N.B.C.
<unk>.
A great. Thank you.
My question I hope, everybody is taking safe and healthy and congratulations on on spectacular quarter. So like question has to do with <unk> see you. The one they sleep cohort pay and the pivotal maybe can we go to great.
Picture population.
Now do you see kinda enrollment help toward the cohort paid is given that you know you have those off can which are chemotherapy free versus <unk>, two and therefore, we should expect really rapid enrollment that timeframe.
So thanks for the question on the covert K. and pivotal <unk>. Roger can you explain what we're thinking of the looking there and you know geography as et cetera.
Sure and and it's it's it's a great question and started to some degree <unk> overlap with with the E.D. three or two but bear in mind D.V. 302 is a billion dollars trial that is we'll have a global footprints.
You want to US we it's more phone because you know in places like the United States.
And there are more than enough patients to to enroll both of those trials. So will you know it's it's what can we do all day, which is to manage try the recruitment and <unk> and to make sure. The trials adequately supported for both of them. So I I don't have any concerns that would be able to you know in <unk> above trials you know <unk>.
Yeah, and that's what we tend to do.
Got it okay.
And then.
Save the company has executed to perfection in the past two years and but luckily the in the presentation. They have some early stage asset highlighted just curious you know clay any assets you know heading a gas care that you are particularly excited.
And just curious on your thoughts.
On you know the progress made on the F.
A you know trigger engineers.
For and that the feeding 40 out that that could be.
I mean potentiator.
Sure. So thank you very much for M- your remarks on how well the company has done over the last few years you know we're focused on cancer patients and you know we've been working really hard to.
You know help cancer patients get drunk to proved you know even during the total bed time.
<unk>, we have dependable range that company for efficiency and people that can work from home are working from home and you know we we have even started to reopen you know under very strict guidelines are laboratories, where we have social distancing and people nasty and gloves, but they're cracking.
The laboratory is working in our goal is to really work hard and execute well to make a difference in cancer patients lives and so we'll make it even trying to make the right decision and focusing on that now to your question on the early stage assets. You know you bring up the S.T.A. 40 program that isn't very exciting drugs that we are developing.
And you'll hear more data about that in the future right now I don't want to disclose any data. It's a it's not ready to be disclosed, we'll just closing out the right time, but it's an exciting program into non A.D.C.
We're doing more and more with non 80, C. plus adding more 80 seems I think we mentioned that into prepared remarks centres. Both 80 season on A.B.C.'s and certainly or last approval in two guys as a nine M.D.C.
Maybe see approved and so we're excited to make a difference in cancer patients in anyway. You know we work on targeted therapies, whether they're targeting cell surface or inside so I think the earliest stage assets are very exciting we have quite a lot of assets and you know, we don't talk about them or too much into.
We have some real data to to show, but I think over the next year or two you are going to hear a lot about early assets and I'm excited about.
Great. Thank you very much for all the question.
They can't next question I'm still then <unk> Oppenheimer.
Oh, Thanks for taking my question congrats on a quarter of.
I've a question on that topic development than <unk> setting <unk> clinical development, most <unk> want to make sure I don't know track here. So first what T.V., one or three M.B. amended pay three now would be enough to file.
And second of our I think it's a pretty big deal to Merck amended ongoing faces ready to <unk>, even prior to seeing the one on free data.
<unk> <unk>, a little more color on how that this happened and and that would mean that <unk> use the combo, it's potentially in your standard off camera setting yeah <unk>.
Well first of all thank you very insightful question you know about this and you know we really we really can't comment on Merck and what their thoughts are and and whatever we can tell you what the trial is and what we're doing we're attempting to do and and why we're going after this and Roger.
Maybe you could give a little color on Muslim they said a lot of cancer and why this is important.
But I don't I'm, sorry, I, just can't comment and we can't comment on you know what <unk>, what Mirpur any company is thinking at this time.
Yeah.
So it's a again, it's a good question and I think the excitement around combining and 80 C. would have a dog and a warhead, which has been shown to not only to kill cancer cells, and and tell them well in bladder cancer, but also set up and immunogenic cell death environment that is potentially.
You know that could help a P.D. one inhibit within the improved immune response, so combining those two and the data that we that we generated out of easy one or three with assistant negligible. You know front line I think gives us conviction that we should take this combination forward you know as.
Prius and of course, we what we off that we are still executing a small cohort in easy one of three but the opportunity to join and already established a registration on trial and taking this combination together into a must have been bayes is saving we think is is really opportune for us.
And next and for expansion is consistent across all of the stages of that accounts well away from advance made a static disease back into the non Muslim invasive cancer and in muscling Bayes of that accounts for so there's no reason to believe that somehow a pet saying people behave differently in that too.
Setting most 'cause already generated day, there was <unk>, which with Katrina, which is pretty exciting taking these two active agents and combining them in the population.
You know for which community is no therapy apart from to stick to me, we think isn't important potential step forward.
A great thing I've heard pick my question.
Yeah, I know that question <unk>.
<unk> plenty of snow.
<unk>.
Okay. Thank you operator, and thanks, everybody for join US This afternoon, you well.
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