Q3 2019 Earnings Call
Good day and welcome to the Seattle Genetics third quarter 2019 financial results Conference call.
This call is being recorded.
At this time it would like to turn the conference over to Peggy Pinkston, Vice President Investor Relations Ma'am. Please go ahead.
Thank you operator, and good afternoon, everyone I'd like to welcome all of you to Seattle Genetics third quarter 2019 conference call.
With me today or claims to go President and Chief Executive Officer, Robin Taylor, Chief Commercial Officer, Scott Anderson, Chief Financial Officer, and Roger Danzy, Chief Medical Officer.
During today's conference call are supporting slides, which are available on our website in the investor section events and presentations page.
We are prepared remarks today, we'll open the lines for questions. We ask that you limit yourself to one question to ensure we're able to get to everybody during our call today.
Today's conference call will include forward looking statements regarding future events or the future financial and operating performance as a company such as those among others relating to the company's 2019 financial outlook, including anticipated 2019 at Suntrust sales and future revenues and costs and expenses and the company's anticipated.
I mean to achieve potential future 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.
Among the factors that may cause such a difference include the difficulty in forecasting sales revenues and expenses.
The uncertainty associated with the pharmaceutical development and regulatory approval process.
More information about the risks and uncertainties space I Seattle genetics is contained under the caption risk factors included in the company's periodic reports filed with the Securities and Exchange Commission, including the company's quarterly report on Form 10-Q for the quarter ended June 32019, and with that I'll turn the call over to clay.
Thanks, Greg and good afternoon, everyone.
No genetics has reached a transformational pointer testers.
Poised to Britain multiple targeted therapies to cancer patients and.
Oh progress as evidenced by significant milestones across all told you portfolio.
Several and only the past few months.
First.
Et cetera.
In lymphoma brand that continues to grow.
Record revenues of $462 million year to date.
84%.
First nine months of 2018.
Under our collaboration went to Canada et cetera is on pace to exceed $1 billion global sales in 2019.
In addition, et cetera remains the focus of a substantial clinical development program.
Oh Gosh in December 10, abstracts will feature et cetera in Hodgkin and T cell lymphomas, including a four year follow up from the national on one trial in frontline Hodgkin lymphoma.
Next in our late stage pipeline.
Lord Abbett, but don't importantly.
The only thing in collaboration with Astellas.
During the quarter, we submitted the beauty away pretty easy and previously treated metastatic urothelial cancer patients and his was filed by the U.S.P.J. when priority review with an action date of March 15 2020.
Improved easy wouldn't be our second marketed product and expand our commercial portfolio into solid tumors.
Are you.
U.S. sales forces in place and we're looking forward to bringing this drug to patients in need.
In parallel we astellas are advancing a robust clinical development program for using across the spectrum of Urothelial cancer, including planned phase three trial in first line metastatic patients.
Roger will provide more detail about the impressive data presented a European society for medical oncology conferences and are developed plans for easy.
Our next late stage clinical program has two cats. This last week, we reported exciting results from our her to CLI pivotal trial after Katrina and metastatic hertwo positive breast cancer.
In patients with brain metastasis.
Trial was a success and achieved its primary and two key secondary endpoints.
Results will be presented at the San Antonio breast cancer Symposium in December .
Due to further support to catnip as a potential best in class her to tyrosine kinase inhibitor.
Our team is already preparing SDK, which we plan to submit to the yesterday in the first quarter 2020.
Just want to catnip inline to become our third marketed product.
Her to climb data also supports our continued investment in the two cats in clinical development program in earlier lines of her two positive breast cancer and other solid tumors such as colon cancer.
So to them up and don't weren't TV.
Late stage program, we're developing a collaboration with Genmab.
Our initial focus in recurrent or metastatic cervical cancer, we expect to report topline data from the TV pivotal trial called innovative tool for in the first half of 2020.
Lastly, investing in our early stage pipeline is a key part of our strategy for future growth.
We're advancing multiple programs and ongoing clinical trials, including let's be appeared to sum up or LTV. We plan to report initial data.
Same BCS from an ongoing clinical trial of healthy plus pembrolizumab in triple negative breast cancer patients. We will continue because this innovative new product candidates into clinical trials, including Edcs and other targeted therapies with several I think as planned in 2020.
At this point.
Turning the call over to Robin to discuss our commercial activities.
Todd will comment on our financial results and 2019 guidance after that Roger will discuss our clinical development activities.
Yes.
Thanks, Hi.
<unk> net sales in the U.S. in Canada were $167.6 million in the third quarter, an increase of 32% compared to the same corner in 2018, and an increase of 5% over the second quarter 2019.
Continuing growth in Q3 reflected an increase in the overall share headline pizza GL patients treated with et cetera.
Same sheraton frontline Hodgkin lymphoma.
The PCL growth was highest newly diagnosed LTL patients with a significant majority receiving et cetera.
Our sales organization is focused on continuing to promote et cetera et cetera. Its broad label now includes six indications. There also emphasizing a three year PFS data from the National one trial in order to continue to shift adoption important backstage hodgkin lymphoma patients.
The data showed that was extended fall off the PFS benefit was maintained centrus plus ABT.
We're narrowing our 2019 et cetera sales guidance to $625 million to $640 million.
No I would like to transition to informed about the do.
We are encouraged by the positive reaction from investigators and key opinion leaders to the easy to one data that was presented at ASCO, there's significant unmet need in metastatic urothelial cancer Whos platinum chemotherapy, PD, one or PD one therapy.
I look forward to provide you option for patients.
Actively preparing for the potential approval and commercial launch I mean, maybe you'd be sales team is fully onboard in the final training to assure them I'm ready to launch a buyout April .
Our sales organization was hard 18 different companies. In addition to Seattle Genetics and has an average for 14 years, One college experience.
Our team is also actively engaging with key pairs to provide information health plan, but a future coverage outdoor reimbursement.
I'd like to TV.
Working in close collaboration with our partner Stellus to ensure the joint person team launch ready.
Moving onto the cabinet.
He is excited by the results are to climb we've been preparing launch plans in anticipation of the data that we announced last week.
Bring up the U.S.U.S. sales leadership team has already been initiated with a focus on deep expertise in the breast cancers things I'm confident we will have a highly experienced cap salesforce in place in advance.
In summary, centrus as the mainstay of our business and we continue to focus on expanding our newer indications of frontline Hodgkin lymphoma and PTCL.
For the potential approvals and launches of eating into catnip after making a difference in lives of cancer patients now I'll turn over the call to talk.
Great. Thanks, Robin and thanks, everyone for joining us on the call. This afternoon today I'll summarize our financial results for the third quarter and year to date and provide a few updates to our financial outlook for the year.
Total revenues were $213 million in the third quarter of 2019 and $627 million for the year to date.
This included record set person itself in the U.S. and Canada of $168 million in the third quarter and $462 million for the year today.
Royalty revenues in the third quarter of this year increased to $27 million.
The $23 million in the third quarter of 2018.
For the first nine months of 2019 royalty revenues were $66 million compared to $59 million for the same period last year.
Multi revenues, primarily reflected set for sales by Takeda and to a lesser extent sales of poletti under our collaboration with Roche.
Collaboration revenues were $18 million in the third quarter and $99 million for the first nine months of 2019.
This included the earn portion of $43 million in milestones achieved earlier this year.
Notably triggered by Takedas approvals have been suffers in frontline Hodgkin lymphoma, and the recent approval approval of the living.
R&D expenses were $196 million in the third quarter of 2019 and $518 million for the year to date.
It's over 2018 reflects higher investment across our pipeline primarily on our late stage programs to cat M. E V in TV as well as the upfront costs of a preclinical assets that we acquired in the third quarter.
SGN a expenses were $96 million in the third quarter of 2019 and $259 million into first nine months up here.
These are both increases over 2018 and reflect commercial efforts to support its ceteris in frontline Hodgkin lymphoma, and PTCL launch preparation activities for easy and costs related to supporting our other late stage pipeline programs.
We ended the third quarter with $870 million in cash and investments, which includes net proceeds of $549 million from our July common stock offering.
In addition, we hold approximately $102 million in the immunomedics common stock these shares or mark to market and contributed to a small investment loss for the quarter and year to date this year, but created some variability in results in 2018.
Lastly, I want to highlight for upgrades to our financial outlook on revenues, we're nearing our ADCETRIS net sales guidance to a range of $625 million to $640 million.
In addition, based on strong sales by Takeda, we're increasing our expectations for royalty revenues to a range of $90 million to $95 million.
On expenses, we're updating our R&D expense guidance to a range of $690 million to $715 million. This reflects the tell technology acquisition that I referred to earlier as well as development activities for easy into cabinet.
And lastly, following the positive her to climb results last week, we expect to initiate several launch preparation activities. This year or two catnip as a result, we're increasing our SGT expense guidance to a range of $355 million to $370 million.
We plan to provide our 2020 financial guidance on our next quarter call.
Now I'll turn the call over to Roger Thanks, Todd and good afternoon, everyone.
The past few months have been remarkably.
So I will recap key on comes activities nominated stage programs and highlight our development plans going forward to maximize the potential of these programs patients.
I'll begin with enforcing appetite.
Positive data from the pivotal TV to one trial in metastatic Urothelial cancer patients who received prior platinum chemotherapy and PD. One PDL one treatment were presented at ASCO and published in the Jim O'connor oncology.
Okay. That's supposed to fall biologics license application was submitted to the FDA July was accepted for filing by his gains of temple was introduced to date of March 15 to 2020.
We had a positive since I actually engage with him.
Portion of the application.
As a reminder, TV previously received breakthrough therapy designation from the FDA in this patient population.
Beyond our initial registration pathway as investment plans are evaluating easy in the first line metastatic setting as well as he just pages of the disease.
This is supported by initial results from the phase one easy when I was three trial presented at ESMO in September .
Reported data from 45 minutes static Urothelial cancer patients, who were previously untreated and Virgin eligible pulses platinum based chemotherapy.
Especially ineligible patients typically receive a carboplatin regimens, which is associated with response rates of approximately 36%.
The study made outcomes for safety and in addition them on those patients who received the combination easy and Pembinas that Matt. The objective response rate was 71%, including a 13% complete response rates.
Total of 93% of patients had production in two mohamad.
The combination of easy and Pembrolizumab showed a manageable safety and Tolerability profile.
Ultimately, we observed responses, regardless of PDL one expression.
Even related adverse events of clinical interest that went great suite or raise a rash hypoglycemia and peripheral neuropathy. These were expected to dance and the rates was similar to those observed with important appetite monotherapy.
Defensive patients had treatment related immune mediated edison adverse events of clinical interest greater than or equal to grade three that requires the use of systemic steroids.
It was consistent with the safety profile in September doesn't have monotherapy, which does not appear to us.
The addition of TV.
Based on these things, we're proposing to conduct a frontline randomized phase three trial.
We will provide additional specifics about our phase three plans in the coming months.
80, plus Pembrolizumab represents the second encouraging data said that it's been generated from a combination of a token based HBC and the checkpoint inhibitor. We have previously shown promising data from the combination of its interests and the volume at and simple lymphoma savings. He believes in the potential of combining our production base.
He sees with immune checkpoint inhibitors, and we already evaluating some of the cost combinations across our AIDC pipeline.
The easy one of those three trial is ongoing in first line metastatic urothelial cancer patients to evaluate the combination of easy and platinum chemotherapy as well as a trip that he be pembina is a map and chemotherapy.
In addition, we recently expanded the trial to evaluate EDI monotherapy and the combination of easy and Kevin. This is Matt in patients with muscle invasive urothelial cancer, who assist crafting inevitable approximately 20% of urothelial cancer patients diagnosed with muscle invasive disease, which is not yet space.
Outside of that there was a significant unmet need when you therapies for these patients.
Lastly, the activity of easy and Urothelial cancer suggest it may have pick application in other nectin four expensing malignancies to that and we understand as plans to start a signal finding trial in other saw the to miss in the near future.
I'll move on now to Katonah oral tyrosine kinase inhibitor the targets to last week, we reported positive topline results from the randomized double blind pivotal trial called her two times.
The trials conducted at 612 heavily pre treated her two positive metastatic breast cancer patients, including 47% to a non type brain metastasis as an entry.
Since received I haven't seen Catherine combinations tries to seven capesize themes or trends to Smith from Capesize and I'm not.
We reported a statistically significant and clinically meaningful outcome on the primary and two key secondary endpoints.
Data showed that the two cats, newbridge them and reduce the risk of disease progression of Dan by approximately half and by a greater amounts in the patients of brain metastasis. Most importantly, catnip also reduced the risk of dance biased food and the overall population.
Two catching up in combination with tries to some advocate decitabine was generally well tolerated within manageable safety profile full results from how to climb all scheduled for an oral presentation and it's a b C. S. On December 11, 29 team and we expect to submit a new drug application yesterday in the first quarter of 2020 .
Next I will turn to Texas, which we are evaluating in several new trial potential registration OTN foam clinical practice. As previously stated we are enrolling patients who are being retreat centrus in Hodgkin at T cell lymphoma progress after privacy laws, including those who received attempts and the fund classes.
We also conducting a tie them consensus in frontline Hodgkin lymphoma, and PTCL patients, who I've said for combination chemotherapy.
In addition to be studies, we recently expanded an ongoing phase two trial to evaluate Texas, a novel combination and the volume App Npls and the cost me in newly diagnosed and pass Hodgkin lymphoma patients.
This regimen exclude sunglass team, which is part of the approved its interest costs ABT regimen and adds in the volume at an blasting is known to Costar property and its interest in combination with volume that has produced promising data and simple clinical trials.
Finding the two most active edge agents in Hodgkin lymphoma, and citrus and the PD one inhibitor enough time regimen has the potential to improve efficacy and reduce toxicity.
Trial reflects our long term strategy to improve outcomes Hodgkin lymphoma patients, where the Texas based regimens. Another its interest opportunity. We are exploring is its use in the treatment of diffuse large b cell lymphoma, we'll keep you posted as our plans for grants. We also have a number of important presentations at ash and look forward to continuing to.
Family. It takes a stay the same hematologic malignancies now I'll turn the call back over to play.
Thanks, Roger before we open the line for your questions I want to recap our key upcoming activities across our oncology portfolio. They include first continue established centrus standard of care frontline, Hodgkin lymphoma, and frontline PTCL and initiating additional clinical trials.
But working with FDA out our E b submission in collaboration with Astellas towards the March 2020, due for date initiating a phase three trial in front line Urothelial cancer, and expanding easy development program, New trials third party to catnip her to claim data at Sep yes.
Submitting an NDA to the F.D.A. in the first quarter of 2020 and advancing a randomized trial in combination with tier one.
And reporting topline results from the TV pivotal trial in cervical cancer in first half of next year.
We aim to continue a positive momentum through 2019 into 2020, as we strive to bring important new drugs to cancer patients at this point, we'll open the line for Q an operator, please open the call for questions.
Thank you Sir.
If you would like to ask a question. Please signaled by pressing star one on your telephone keypad.
You are using speakerphone. Please make sure that your mute function is turned off to like your signal to reach.
Again, Please press star one to ask a question.
And I first question will come from Michael Smith with Guggenheim.
Thanks for taking my questions I actually had a quick pipeline question on.
To sum up yes, you mentioned death.
Rightfully, so I think a lot of excitement around combining you know your 80 seized with PD, one inhibitors and you didn't mention the upcoming presentation out the the Keytruda combination study it.
Yes, I was just wondering if you could help a little bit more with you know what investors expectation should be with respect to this update from the beep.
That's coming up here later.
Michael Thank you for the question. So we are very interested in the live one.
He see it's interesting molecule. It certainly active we've shown that presented that has a single agent activity and we are continuing to evaluate it as a monotherapy and also in combination pembro.
We are not yet ready to go forward and announce.
Registrational, our phase three trials, but we are.
Renewing to develop it and try to maximize dose schedule.
Monotherapy combination with Pembro ad.
We're very excited about that clearly say BCS will be a promise Seattle genetics standpoint.
Big.
You know a big show up catnip, because we have a lot to discuss there, but liv one is also important to us and.
Additionally, I might point out that the basket trials and trial in a variety of different tumor types said.
That have Liv one expression has recently opened so that's something we're working on as well.
Great. Thanks.
On a lot. So you mentioned the upcoming.
Right.
For the TV study in cervical cancer from me.
<unk> tool for trial can you just remind us off through.
Occasion for what the clinical bars here into the efficacy to that too.
<unk>.
Yeah, there's a lot there and maybe I'll give you a few comments, but Roger can also follow up and if you look at relapsed.
Cervical cancer, it's a it's like grim prognosis no one survive since this is bad and despite carticel and vaccines not everyone gets vaccine across the globe and in the U.S. and so there's still unfortunately I need for therapies for relapsed cervical cancer and if you look.
Perhaps the most recent approval in cervical cancer it was pembro.
In and ER.
PD one high Expressers with a 14, that's one 4% response rate, but they were durable responses and if you look at chemotherapy that has been use and a lot of publications. There are I would say the range is probably somewhere between 8% and maybe 16.
17% response rate, sometimes with durations that are tiny.
Measured in two months duration, whereas with a checkpoint you can get you know a year or so of duration, which is.
Likely why it got approval, even with needs de Minimis response rate because it had duration. So I think those baby can help you give you said landmarks up what's out there and and clearly we want to do do well by patients and habit best in response, we can happen with single agent look at this computer.
Sure in combination.
Roger do you have any.
Color you want to add beyond that.
I agree with some comments.
Is it by historical precedent and we need to wait for the TV results. He how they match up.
Great. Thanks, Theres lots to talk about obviously, but congrats.
Probably the quota.
The Q.
Thanks.
Thank you. Our next question comes from Canada, Mackie with RBC capital markets.
Hi, Thanks, so much but during the question congrats on the quarter Andy.
Narrowed and slightly raised guidance, maybe a quick commercial question first I'd hope for a little bit more color on the growth of its interesting stuff on p. fields and the higher growth in CTC elsewhere. It's like two factors are at play all of those patients are cdthirty positive and I think though TCM guidelines, there, maybe a little bit more generous versus other piece.
Yes, I was wondering those two drivers.
Which had been the bigger impediment to use outside of CTCL sort of locked abroad, CB thirtys testing, there or just not give supportive data and really what can be done about that could increase utility outside of T cells.
One quick follow up.
Okay. So you.
No. There has been a lot of worked on I'm looking at Cdthirty expression.
In both CTC L and PTCL, if you and if you asked scientifically are their patients with PTCL and CTCL that are absolutely negative precede 30, I could not with a clear conscience say that there are patients that are truly negative.
What I can tell you risk there are some patients that have low scores on histology when looking at a single nodule, but if you look at other nodules they could be higher keep in mind CD 30, as an activation and Chen and if you take some tissue to set our low orient background with histology and you do other types of techniques.
Well look at expression you can see cdthirty expression there so to me it's not totally.
Yes, our CTCL PTCL cdthirty positive or negative it's more of a.
What ray what the expression level is and our some really in the background of histology, which is kind of a blood tool, although readily used across different cancer centers. So it's an easy tools. He is so having said that you know you're asking about what could we do about that how can we grow and there's been trying.
Ill start and evaluated for instance, and CTCL that were presented not that long ago, showing that you have CD 30 positive in the city 30, I will call histology negative and then the doctors treating both population had really good responses in both there was a little bit higher in the Cdthirty positive.
Then a CD 30, histology negative, but they certainly weren't CV certainly not going up and so I think that there are a lot of things that we could do as we get out there. It's you know as just a product is in the field Lager and study this and Roger you know a lot about expression of this and.
Thats something that you want to comment on and Oh, Yes, No I think and plays plays made the point that that is a dynamic nature to the expression and there was a sampling variability and we have data not just in CTCL, but in other diseases as well with Cdthirty expression, one would expect it to.
Mark for responses, maybe have a parent cdseventy negative negativity, where we see response.
From a a testing perspective, obviously pathologists are an important part of this and getting the falling just to understand the importance now off CD 30 testing and PTCL because he is a therapeutic I can make a difference is something that we are obviously focused on and interested in trying to improve.
Option of scoring and the appropriate reporting of pathology.
Great. Thank you very much and then I have one quick.
One follow up I'm up here in Boston that the eight feet.
You are Tc triple complaints and some of your data on the next generation pig good color.
We encourage them to get actually payloads was presented a pure media neighbouring higher payroll deliveries per BDC can you maybe help us understand <unk> utility of abuse technology, because I think this is getting used on one of the next generation 80 seats STN to 28, Hey.
Richard Goodman Phase one could if I am right on that could you maybe help us understand when we might be.
Some about initial data and what to look for in that Doug. Thank you very much congrats again.
Thanks, Ken so.
Thank you for introduction to talk about stuff, that's part of our growing technology and our leadership in Nbcs. So we are really excited about our newest AIDC in clinical trials that.
We called to 28 and targets.
You need to tweak or whats referred to as key 97, and this is expressed on a variety of solid tumors and we have also not only just use this target, but we have used a new confirmation.
In a 80 see that.
Utilizes pet groups utilizes an eight load you may be aware that with et cetera, and with LP, we utilized approximately four drugs.
Per.
Antibody molecule and with our newest technology to 28, Oh, we're using eight trucks per antibody molecule, but it has a completely different linker and a completely different stabilization agent and we've been working on this and it's in clinic now and.
It's an exciting prospect for us what did they get [laughter] excuse me what are the commitments that we paid is.
After we became an industry leader in 80 C is to stay there and that's to continue investing in our technology and continue to make drugs that are more potent but also safer and try to work on our Lincoln systems to make them more.
Specific for the tumor. So this is one example, where we are very hopeful with our technology and we are investing in new agencies, but as you will see going forward. We have a couple of new technologies to build on what we already have isn't leadership positions and I think that the future will be.
Hey, good one for Edcs, not only at Seattle genetics, but in other companies as other companies are making advances that really helping patients.
Thank you. My next question comes from housing sector with Goldman Sachs.
Thanks could you just comment on the next step is pretty cat they have been colorectal cancer and perhaps plans looking at the other indications such as gastric where the frequency of her to over expression is much higher.
Thank you very much for the question Roger can you talk a little bit about maybe our data and what we're doing next and then also touch on other diseases.
But so thanks for the question and obviously, the so to climb results, which are really.
Have you remarkable does point to the potential basin classmates are off to cap.
So we are interested in essentially creating a program around to cap note, which will include expanding into other areas of breast cancer types already mentioned the tdm, one trial, which is essentially metastatic disease, we haven't yet enrollment efforts through I spy too and we are looking at other areas as well with regard to hit your exposure.
Shifting to Miss the outside of breast cancer, we did have very exciting data a small data set but very exciting at at ESMO and with the combination of tries to snap to kathman for the response rate, that's north of 50% and looked pretty durable.
So we're excited about taking that on so much. So the debt wasn't investigator initiated trial, which we've taken over you know essentially only I, India and the Todd is now Seattle genetics corporate sponsored trial.
And we plan to continue.
Continue to evaluate third lung colorectal cancer her two positive.
Moving to a patient population utilizing the mountain and trial and that obviously is that data is is reproducible would you think it will be that's an area of potential.
Seeking potentially distraction outcomes and in earlier lines of colorectal cancer, even though the frequency is in the sort of 2% to 5% range. Nevertheless, it's an important unmet need if it's a large addressable population somebody working on thinking about what we can do earlier with regard to gastric exactly as you say this is another opportunity and we.
Already have sold through internally, what a development plan could look like we're not ready to share that information at this point, but we are differently.
Interested in gastric and potentially other hotels spacing, Tim as well.
And a follow up if I may and at this point how much is a challenge triferic tetrasun revenue growth first its PTCL.
You know.
I'll turn it over to Robin in a moment, but.
The general answer is we really don't split them up and both of them are very important to us prop and you want to give a little color.
Sure.
Did shell is certainly.
One of the key revenue growth areas for et cetera.
And I think there is certainly room to grow.
We've seen good uptake both PTCL in Hodgkin lymphoma, HQ Hodgkin lymphoma is really facing a much more entrenched usage.
Chemotherapy.
For your PFS data, we presented has really helped us get traction in terms of physicians understanding the benefit of et cetera.
We will have for your follow up data at Ash I think as the data matures with echelon. One one can see the there is like we've seen that continued benefits from the three year PFS data.
The more we can show that there isn't a during benefit I think the more than we are going to be able to convert physicians. So understanding the benefit of et cetera.
In terms of the relative contribution you know as Clay said, we don't we don't split those up but I believe that Hodgkin lymphoma is continuing to be.
And driver for us.
We've seen obviously rapid uptake with PTCL as well and I think that's a that's been very encouraging.
Thank you.
Next question will come from.
Barclays.
Thank you for taking my questions during the first one or so they got into commercial question.
Sure I'm wondering how their first month PTCL Hodgkin lymphoma gross chicken gross rate in this quarter compared to the last quarter.
So we we don't report the specific growth of.
The disease types.
No as I as a whole we've had a lot of growth year over here again quarter over quarter, we crew.
You know about 5% and so.
That is a it's a it's a it's a strong growth rate, it's within what we have it for guidance.
And we're excited about that and we expect that.
Centrus overtime year to year, we'll continue to grow as a brand as we make for progress there, but you know these specifics of.
PTCL for instance, as you asked is not something we present, what I will say is that with PTCL, we had oh, yes.
From our first data set so it is a a less challenging.
Discussion with doctors when you go out with though as data were with Hodgkin lymphoma. It was contemplated to be to take a number of years to get there because you need a certain amount to.
Events to hit statistical value. So we're not there and it is important for us to follow the protocol as it said and assets written and try to get to those events, but in the meantime.
The gold standard is five years and docs look at that with Hodgkin lymphoma, you know our initial data, which we we published.
So two years worth of data and some doctors and it was great data some doctors converted at some did it and then last year, we put out or three years data and we had a nice bump in our in our revenues and more docs took it on.
The data got actually better it wasn't just continuation of two to three years. It look better and now this year, we're going to show our I'd ask coming up and a couple of months, we're going to show for your data and then next year, presumably at ash, but it's way too early to speculate.
We'll show the five year gold standard data and I think that that will go a long way.
To addressing any questions you know without even having.
Oh West data. So we're really excited to continue to age the data and go forward.
Great and then just quick follow up real quick question regarding the lumber.
And so you Didnt mention that you plan to start when I think in my for Phase three trial. It looks like just wondering any additional color you can put right into giving those invigorating 130 basis.
<unk>.
And maybe thinking about Tripoli.
Your first.
Or will be <unk>.
Thanks.
There is good.
So we have not yet spelled out the exact trial.
Thats something as soon as we start the trial, we will spelled out that's been our history that it's not appropriate to state. The exact trial until it starts so stay tuned we will be doing that but Roger perhaps you can give some color on your thoughts on in vigor and the kind of approaches we can take to go toward approval in Europe .
And so.
Thanks Clay so as you can see that you'd be when I was free trials.
Office your roadmap as to how are we thinking about what possible combinations, we can use and as clay said, we haven't disclosed those but you can get a sense. So the day digit generation that we will need to support the phase three trial with regard to they go it's a positive trial.
Just I didnt quite make into obviously from a from an efficacy to stick to it although it's hard to cross compare.
Encouraged by all you need Pembro data.
With as you know response rate of 70%, which isn't unusual outcome.
These.
And again trust cost trial comparisons of have limits for sure, but the response rates that were shown with the.
Isn't doesn't matter together with chemotherapy would suggest that it at this point anyway.
What Oh plans to proceed into a frontline trial.
I would suggest that we have good shot to potentially improving the outcomes further.
Hi, Thank you.
Our next question comes from Andrew Therein split SVP of Leerink.
Good afternoon, Thanks for taking my questions.
Yes. This was primarily for Roger well one of the Buzz is the came out of the you'd be presentation in Barcelona was potential synergies between the boat.
Checkpoint.
And I think it's one other things a lot of investors are also thinking about regard out of value the platform.
You guys have any additional color for us regarding what could be driving potential synergies and is there anything about.
Regarding tailored for the link or a differentiated series in regard to upgrade the approaches.
Sure Roger sure. Thanks, Thanks for the Christian.
So.
It's the Holy Grail, that's drug development is to be able to two drugs together and have a better outcome than in the individual drugs.
And certainly that response rate is high proof of synergy is a very different thing, which caused the high level of scientific rigor and what I cant what I can say is that from a mechanistic perspective, if you think about what an 80 years, it's essentially a targeted therapies. So it's delivering a payloads to agree.
Tumor so.
Inducing in those two myself things like immunogenic cell death rent because of stress.
Such that the the tumor micro environment may become favorable for an inflammatory response and May in fact, the amenable then to an immune response that would be assisted by taking a break so at immune response by giving a PD one PD one inhibitor.
And in the sense of excuse me chemotherapy may be much more much more permissive in terms of what other cells could potentially damage on could speculate that limited delivery.
I'll decide to toxic payload just a tumor cells may keep the micro environment more intact. That's one.
Let's see with regard to the actual data.
In terms of what does could 71% represent a represent synergy what is interesting is if you look at the data you can see that is a response, regardless of PDL, one expression, which is encouraging.
We don't have TV monotherapy data at this point to sort of makes a comparison. So it's very hard from a pure numbers perspective to say this is what would you expect with Pembro and this is what you could expect from easy.
But regardless of whether its synergy or not the clinical data pretty compelling. So the compelling asked to move forward and development program.
Okay is there anything about the specific way or your linker technology that could could make a card for another 80 see that similar effects.
You know any you're asking a really good question and there's a lot of work going on in our research effort that I do not a research group I should say that do not are not ready for a full discussion and were what we're doing is in general is we're evaluating all the different.
Type of payloads and their impact on immunogenic cell death, and I can tell you that they're not all the same.
And.
You know, but don't.
Work really well, there and I don't want to say more than that at this point.
At some point of future will put out our our our research data and appropriate conference like an SCR type conference but.
We're really excited with our choice of the dose.
And and how they work well with immuno oncology agents like PD ones.
Thank you. Our next question will come from MBS with William Blair.
Great. Thanks for taking my questions and congratulations on the quarter.
Oh, so it's encouraging to see that Seattle is really hoping to expand the frontline treatment paradigm for Hodgkin lymphoma, and also MTCL. So just curious <unk> bees phase three trials, usually take anywhere from.
Three to five years to run anything you guys learn from the echelon programs in terms of potential surrogate endpoint to kind of shortened these trials.
So it's a good question I think especially in Hodgkin lymphoma space. There you know this the stage one or two that we didn't we do not yet have approval in for example, and despite that there's a lot of good data that's been presented but albeit there relative.
The small trial and they're not approval trial, but the data strong and I think that when you look at.
Work, that's going on whether it's in Europe was with consortiums or cooperative groups in the U.S. or corporate studies I think that there's a building momentum for using et cetera, and a lot of lines of Hodgkin lymphoma, but we have to continue really powering.
True trials and try to look at some novel endpoints such that they don't take very long and I think that that is something that is up for discussion with regulators I can't give you any.
Details on that Roger is there anything else you want to say based on what we can yeah. I think I think plays right through up it's not just corporate trial the trial.
You know what can be Sandy Lowe ontime trial, the corporative groups and so on which are important entities.
Execution.
Interested what we talked about today was was the signal finding study to see if we could.
In a single arm trial, so working for them as hits Us Nivo.
You must into Cabazon combination could look like in front line advanced Hodgkin lymphoma, and we think it that data is compelling enough that could then be the Genesis, we get more work on the by ourselves all by others see because the ultimate goal is to cure as many people as we can and that's I think what our focus is.
In terms of developing new treatments for Hodgkin lymphoma, new combination.
And a follow up if I can so in terms of deal B.C.L. King.
Clearly I think in 2015 Gasco.
When the company decided to forego the front mine.
Opportunity.
I'm just wondering what what changed there I think you mentioned about just.
The the markets were were pretty crowded.
Given kind of failures in the frontline setting one with rebel mid one with Imbruvica is what are those kind of the genesis behind the rationale to look at.
Potentially frontline deal Bcl again.
So first of all we are in NCCN with deal Bcl and so we hear back from doctors, who utilize it and that's an important thing to try to understand what's going on in the world and we figure that out over the last couple of years and have been able to talk to docs and been able to.
I understand.
The benefit that et cetera test and deal Bcl the landscape has changed and not necessarily Oh, we had big victories as you say and you know there are other specifics that we have in mind, but we we have not announced a specific trial yet.
And but you know, it's coming and were excited with it and it's something that we need to Ah you know, obviously work through regulators and with the team here at Seattle Genetics and were we're trying to go forward and see if we can get another label in deal Bcl So stay tuned.
And on that.
Great. Thanks for taking all my questions.
Thank you. Our next question will come through sanctions with up there and there <unk> capital markets.
Hi, Thank you for taking my question a few quick ones from this year and actually I believe you will have to for your update for each online on the P.S. as prime.
Please bear with us when should be that no oh, let's update for each product line.
Yeah, like I said earlier in the call.
Oh, yes.
Has a preset.
Ah target number for events.
And at that point is when we open up the trial and we have not hit that it is.
Has always been contemplated to be quite a number of years. So we're just not there and it would be inappropriate for me to try to tell you when I think it's going to be since it's a hard prediction in the meantime, we are.
Getting PFS data and our PFS data is aging from two years to three years four years presentation and a couple of months at at Ash. We're excited to do that and then next year hitting that gold standard a five years PFS and that's we get closer to the five year PFS.
Data Dot time point doctors ask about.
Oh, yes, less because if you're at five year PFS and your lines are pretty flat in the Kaplan Meier plots.
That signifies really what the doctors do turn out so.
While we are growing and planning on getting O S. I think that five here.
This is gonna be very significant as well.
No problem and next lines that given the strategy update from her to climb and the fact that you already negotiated her to kind of.
Q4, two cabinet plus actually didn't warrant, we actually look forward to including this market opportunity in our model. So how should we think about the size of that indicated patient population put to cabinet and keep in mind combination considering that dynamic in the treatment every NASCAR hertwo positive breast cancer patient.
Right well you know, we haven't really come out yet at this point and talked about the size of the population I mean is a little premature for US. We just came out with our data to start talking about what we think size of population is and you know, which which leaves right into it.
Marketplace discussion, which leads into a pricing discussion.
We have done a lot of work on this we have been doing a lot of work we're intending for her to climb to be not just at U.S. product, but the global product I mean, we have a randomized study and a great.
Great dataset, we're really looking forward to presenting at dataset at San Antonio and.
So I think that the market opportunity is substantive.
And and you'll be hearing more from us on that in the future.
Thank you. Our next question will come from silver in Turkey.
Thank you for taking my question and congrats on all the progress this quarter.
It's very promising that you're thinking about moving into a Muslim base of.
Bladder cancer with TV, what types of data have you seen before to inform the utility of TV in this setting.
Thanks for the question I will turned over to Roger to give you his thoughts on muscle invasive bladder cancer, which is a really big opportunity.
An unmet medical need opportunity, but we have not we have recently opened a cohort of patients. So we're just now treating our first patients and muscle invasive. So if you're asking you know what is our clinical data. We're assembling our first clinical data if you're asking about preclinical about why we are looking at.
We have looked at expression of DECT and four and you know the pre metastatic dates and certainly its expressed a strongly there as well and there's been a you know a bunch of preclinical work that's been done to show that we think that this could be very effective and not only muscle invasive.
But you know it or even earlier stage than that non muscle invasive so in all stages of bladder cancer, which is a very substantial size market with a about 80000 incidence in just the U.S. each year for those three types of cancers. The metastatic the bustle base event.
Non muscle invasive so a lot of preclinical work you know a substantial amount of clinical work in metastatic boasts a single agent in combination and now we're treating patients in muscle invasive.
Roger if there's other details.
Yes, so easy is obviously active in metastatic disease, and so one month and it's not it's not a difficult step to take.
<unk>.
Expected it may have meaningful activity in mix imports pricing.
Non metastatic disease, and so I think that's where we are we obviously as clay said need to generate the data. So you can see exactly what the effect of even monotherapy as.
And also look at the combination them and as you know landscape from us invasive bladder cancer, because he was a meaningful unmet need is busy right. Now there are lots of trials that are running and so understanding you know what a rigs you pass forward could look like that we already have evidence we have booked examples you know ahead of us.
And so if we if we are able to take easy into a randomized trial.
It's actually a populations puts into assist ineligible ansys eligible and the reason why.
Insist eligible buses ineligible because that's the only drug goods.
Sean was the second combination is the only a combination that's shown to actually have benefit.
The in the muscle invasive space and so you can see clinical trial designs compartmentalize those two populations.
And and we would be interested obviously in both we have generated data with the pembro in assessing that was we'll get a static population. So we do have that first piece of information and just stay tuned and I've been looking on on moving TV forward into these Bolivia.
Oh that a cancer.
Great. Thank you so much.
A quick follow up if I may.
I'm also encouraged that you already expanded to cut that what made you initiate takotna plus a cut silo and with anything promising that you've already seen into her to climb dataset door or is it just a commercial.
Friction.
Please keep in mind that there was a study that had been done an early study that was single arm not randomized, but a combined to catnip and cats, Iowa and the data had been presented at a conference and they were very strong. So we do have the early data and to us.
Together with the early data and the outstanding her to climb data that you'll see in San Antonio It makes sense to go earlier in line and invest in at this time, it's a randomized study and so we don't need to do another single arm study, that's been done and the safety and efficacy or the risk benefit as some docs caught.
Look pretty darn good.
But it was a single arm study. So we are investing in a randomized study that is up and running.
Great. Thank you so much for taking my question.
Thank you.
I last question comes from 15, I'm not bank of America.
Hi, guys. Thanks, so much for taking my question, maybe tied a cap on the financials. So as as you guys diversify out away from that that trade spend a lot of the keys study of friends that first half read out.
You are putting more money now into the rest of the pipeline, whether it be easy or two catnip or TV.
Give us a sense about the weighting of of expensive from modeling purposes for for E V versus the rest of the program on a go forward basis.
We assume that easy as the bulk of expenses just based on what you said or do you think that you know it will be more equal spread across all of the our pipeline products. Thanks.
Yes, so great question I don't know that I can give you specifics on exactly how it spreads, but historically is set for us has been.
Predominant driver works, but.
We've now got six labels, we run a number of very large critical trials in.
Well, we're continuing to do additional work some of which your hurdle in the call today, it's becoming a probably a lower overall percentage of our investment in R&D, what is nail really starting to come forward, our investments and programs like me.
Here as you heard today, we've got to a very expansive development program.
For that co pay and as well as to cabinet I think the her to coin data to US turns this into a program not a critical trial.
You've heard a little bit about our work that's already starting in combination with kept sarulla in lines of therapy before the her to climb setting and then certainly we're looking at things like colorectal cancer, where the data that we presented at ESMO were quite encouraging so I think maybe.
To get back to your question I think you'll see a growing share of expense hitting programs like can afford it may have entered catnip.
So first we'll continue to be substantial but probably.
Becoming a smaller contributor to the overall part and then well obviously looked to see what else comes out of the pipeline. We've got TV in a pivotal study is a very broad.
Portfolio of earlier stage assets that we just talked a little bit about today.
Thank you.
Our next question comes from Chad Messer Needham.
Great. Thanks for taking my question Congrats on all the on the recent progress.
First real quick is there anywhere you can say about the the preclinical assets that Tom referred to in the prepared remarks, maybe even just a rough idea what the spend on that was.
Well I can tell you or.
Not from a financial standpoint that we do a lot of different deals and we bring in technology. We bring in preclinical assets. This is this has happened almost every year, we do a small ah different deals and some of them you know worked out really well and some of them just in our research.
Our trust.
And how you could talk a little about why it was in a while you mentioned it sure. So you know not that it was a huge deal but it was the principal driver why we increased our or do you guidance just a bit so I will I can't give that the numbers out but that was the main contributor and as clay mentioned, it's a really interesting preclinical assets.
But we think could become a critical asset you relatively soon so that's what got us excited about it.
Oh, great Yeah, that's very helpful and it just just for a follow up me couple of questions here, but they're all very related if you could indulge me I'd I wanted to go back to the TV. Luckily you mentioned, how terrible relapse cervical cancer is and they're.
Not everybody gets activated so it's still a problem what.
What is your view of the.
Opportunity in relapsed cervical cancer, but also for TV I know you're looking at a whole bunch other.
Cancers that express tissue factor.
So you know your.
Your.
Well on the opportunity for a tissue factor targeting therapy more broadly and they tissue effective itself. He can you just remind you that is is that sort of it's buried in the expressed across tumor types. You know say like a CD 30 years or is or is it a little bit more uniform.
Thanks for taking my questions, but.
Sure. So first of all on TV.
We are we are expanded past just cervical for sure. We have a trial that's listed on control dock up Thats in ovarian cancer and we have a basket study, we're working on and other types of cancers. So stay tuned for us to report in the future when we have enough substantive.
At appropriate peer reviewed conferences like we always do on the data outside of cervical odd that that we're working on so there's a lot of interest in it and you ask about the expression of tee up or tissue factor and.
Thats something Thats expressed broadly on solid tumors at very high density, it's not really a team target. So I wouldn't expect us to go and do a lot of lymphoma leukemia myeloma type work with it rather it's more on the solid tumors that you would expect the big solid tumors.
And expression on cervical and things like ovarian a very high so a really good targets and are.
Importantly diseases that need.
Additional therapies that have unmet need for for a lot of patient. So we're really excited about our partnership with Genmab working on TV and we continue to look forward to presenting more and more data.
Thank you Sir we now have no further questions in the Q.
Okay. Thank you operator, and thanks, everybody for joining us today have a good night.
Thank you ladies and gentlemen, this concludes todays teleconference. You may now disconnect and please enjoy the rest.