Q1 2021 Seagen Inc Earnings Call
Good day and welcome to see Jan first quarter 2021 financial results conference call.
All participants will be in listen only mode should you need assistance. Please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be and opportunity to ask questions. Please note. This event is being recorded I would now.
And I'd like to turn the conference over to Peggy Pinkston Senior Vice President of Investor Relations. Please go ahead.
Thank you operator, and good afternoon, everyone I'd like to welcome all of you to <unk> first quarter 2021 financial results Conference call. This afternoon, we issued a press release with our results. The press release and supporting slides are available on our website and the investors section events and presentations page speak.
Speakers on today's call will be close to Gal, President and Chief Executive Officer Chip Romp Executive Vice President commercial U S. Todd Simpson, Chief Financial Officer, and Roger Danzy, Chief Medical Officer.
Following our prepared remarks, we'll open the line for questions. We aim to keep this call to one hour and so ask that you limit yourself to one question to give everyone an opportunity to participate in Q&A during our call today.
This conference call will include forward looking statements regarding future or anticipated events and results included and the company's 2021 financial outlook anticipated product sales revenues costs and expenses and potential clinical and regulatory milestones, including data readouts regulatory submissions and approvals.
Actual results or developments may differ materially from those projected or implied in these forward looking statements for.
There's that may cause such a difference include the difficulty in forecasting sales revenues and expenses impacts related to the COVID-19, pandemic and the uncertainty associated with the pharmaceutical development and regulatory approval process.
More information about the risks and uncertainties based by sea. Gen is contained under the caption risk factors included in the company's annual report on form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission and the company's subsequent reports filed with the SEC and with that I'll turn the call over to clay.
Thank you peg and good afternoon, everyone.
Following a transformational 2020, we continue to make substantial progress and the evolution and global expansion of our business we.
We remain focused on investments to maximize the opportunity and value of our assets fueling our ability to advanced cancer care worldwide.
And we look forward to sharing key business regulatory and development progress on the call today.
We reported record net product sales of $303 million and the first quarter, representing 3% sequential quarterly growth and 52% growth over the first quarter of 2020.
These results reflect rapid adoption of both passive and to Kaiser and top up strong sales of et cetera.
Our financial strength is driven by product sales as well as royalties and multiple strategic collaborations.
We ended the quarter with $2 5 billion and cash and investments, which positions us to expand our programs advance our research and development and invest in our business.
As we look ahead, we're focused on three strategic priorities to drive continued innovation and growth.
Focusing on these key pillars will ensure our organization is aligned and empowered to deliver substantial benefits to shareholders or employees oncology health care providers, and especially cancer patients.
Our first strategic priority is to maximize the global potential of our three approved medicines through robust clinical development programs and exceptional commercial execution.
I'll begin with ADCETRIS, a remarkable product that is the foundation of care and multiple CD <unk> expressing lymphomas.
With six indications and the U S et cetera serves as the basis of our core business.
Etc is commercially available and 76 countries and importantly.
Importantly, our partner Takeda continues to pursue additional approvals for frontline Hodgkin lymphoma, and peripheral T cell lymphoma and its territories.
We are committed to maximizing etcetera is patient reach and are advancing a clinical development program and Hodgkin lymphoma and multiple other malignancies, our global success with etcetera is enabling us to continue investing and our pipeline and newer medications.
Our next key product as pad set a first in class ADC that has quickly become standard of care and previously treated metastatic euro filial cancer locally advanced and metastatic Euro filial cancer is an aggressive disease with poor survival high associated health care costs and limited treatment options.
Pat said is the first drug to improve survival. After patients have received a platinum chemotherapy and checkpoint inhibitor <unk>.
Since the beginning of 2021, we've made substantial progress with health authorities toward expanding the U S label, and securing global approvals across Europe, Asia and Latin America.
Roger will share details about these activities during his remarks.
We're also advancing two trials designed to redefine frontline treatment for metastatic euro filial cancer patients globally with a focus on the combination of pads and keytruda.
And we continue to make significant headway and exploring earlier stages of bladder cancer.
In collaboration with Astellas and Merck has said is being tested in two randomized phase III trials and muscle invasive bladder cancer patients and we intend to initiate and exploratory study, Pat said and non muscle invasive bladder cancer.
Our third key product is to Kaiser a best in class her two tyrosine kinase inhibitor for her two positive metastatic breast cancer patients with and without brain metastasis.
<unk> is now approved and 36 countries in February the European Commission approved to Kaiser and the EU and the regulators in the UK granted its marketing authorization and Great Britain.
This is a significant milestone for patients in Europe, who.
Well for the first time have an approved medicine that has demonstrated a survival benefit for her two positive metastatic breast cancer after disease progression following two anti heard two treatment regimens.
In anticipation of these approvals over the past year, we've established affiliates and key European countries and build teams with deep industry experience. We recently launched two Kaiser and Germany, France and Austria.
And we're pleased by the early uptake physician feedback and that to Kaiser has already been included in some key treatment guidelines given the strength of clinical evidence.
Through our expanded European footprint, we are poised to execute upon another upcoming to Kaiser launches and collaborate with individual countries to maximize its ability availability and patient access.
In addition to this commercial progress we are conducting a broad clinical development program designed to maximize two kaisers potential including trials evaluating it and her two positive breast colorectal and gastric cancers and and her two mutant tumors.
Our second strategic priority is to advance our late stage programs towards securing approvals for new products, one such asset is to soda map Adobe or TV earlier. This month FDA accepted for priority review, our BLA seeking accelerated approval for TV with an action date of October 10th.
The submission comprise data from the innovative tool for pivotal phase III trial.
Which was presented at ESMO and was recently published in the lancet oncology.
This is an important development and the treatment of cervical cancer, which remains one of the leading causes of cancer death and women globally.
<unk> is positioned to be our fourth commercial product as we look to expand our portfolio further and together with our partner Genmab and we are preparing for its launch.
Our third strategic priority is to advance our innovative early stage pipeline through continued leadership and innovation and antibody drug conjugates internal R&D investments and corporate development opportunities.
Our earlier stage pipeline includes seven programs in clinical trials and multiple preclinical assets advancing toward Indies.
I am proud of the remarkable progress, we've made and growing and evolving our business and assets to better meet the needs of cancer patients next I'll turn the call over to chip, who will discuss our commercial business and then Todd will provide an overview of our quarterly financial results after that Roger will detail, our clinical development and.
Pipeline progress.
<unk>.
Thanks, Clay or three approved products are important first in class or best in class and medicines that are and embraced by oncologists and patients. We believe that each of the brands have blockbuster potential and we continue to invest and our commercial capabilities to ensure we can maximize the opportunity to gain future approvals and label expansions.
We are engaging with our customers through multiple channels and are pleased that most of our sales representatives have been able to safely return to making face to face calls.
Et cetera sales were $163 million, a 1% decline versus Q1 and 2020.
The COVID-19 pandemic continues to impact Hodgkin lymphoma diagnosis, but we are seeing early signs of recovery and despite this headwind we have maintained share and our frontline indications we.
We are monitoring these trends and it is our expectation that diagnosis rates will return to historic norms. We continue to message the landmark five year echelon, one progression free survival data and frontline Hodgkin lymphoma. We are encouraged by the favorable reaction to the data we received during recent market research with physicians.
Moving on to Pat says first quarter sales were $70 million double the first quarter of 2020.
We are pleased with our quarterly growth after a strong launch our efforts continue to focus on promoting the full breadth of the paths of label.
For locally advanced metastatic euro for the year old cancer marketplace is rapidly changing and we are confident that Pat said is well positioned this year for continued growth as the market evolves.
Our sales representatives have been proactive and educating healthcare providers on our label update and customer sentiment remains positive on pad subs risk benefit profile.
Transitioning to the Kaiser and first quarter sales were $70 million and increase of 14% over last quarter. These.
These results are in line with our expectations given the challenging Q1 patient co pay dynamics of oral and political.
We continue to gain market share in both patients with and without brain metastasis.
And the queso provides and overall survival benefit for patients with and without brain Mets and we are confident that we can continue to drive share gains for all patients.
<unk> is now the most utilized product and second and later lines for her two positive breast cancer patients with brain Mets.
And finally, we are very pleased to receive a priority review for TV.
A brand team is in place and we're working closely with our co promotion partner Genmab.
We will be ready for a launch ahead of the October tends to do for date. If approved this would be and important new drug for women with metastatic cervical cancer and we look forward to adding it to the proven CJ and commercial model now I'll hand over to Todd.
Great. Thanks, chip and thanks to everyone for joining us on the call. This afternoon, our financial results for the first quarter reflects significant progress across the business I'll briefly summarize our financial results for the quarter, which are in line with our expectations for the for year two.
Total revenues were $332 million and the first quarter of 2021. This included net product sales of $303 million from et cetera, as pad seven to Kaiser representing growth of 52% over the first quarter of 2020.
Growth and product sales is driven by the continued strong uptake of pads and 7% kaiser's since their launches and the U S.
Royalty revenues and the first quarter of 2021 increased to $27 million compared to $20 million and the first quarter of 2020.
This growth reflects royalties earned on increasing sales of ADCETRIS by Takeda as well as royalties on sales and Paul will be by Roche and blend rep by GSK.
Collaboration revenues were $2 million and the first quarter of 2021 compared to $16 million and the first quarter of last year.
As discussed when we gave our 2021 financial guidance collaboration revenues are primarily driven by progress dependent milestone payments from our collaborators, which causes quarterly variations and revenue in the future. We expect collaboration revenues to reflect the profit share from astellas from sales of pads and.
And its territories.
Cost of sales and the first quarter of 2021 increased to $64 million. This included product cost of sales and royalties for each of our three brands the pads a profit share of $33 million to astellas as well as noncash amortization.
Of acquired technology costs for Takeda.
R&D expenses increased to $230 million and the first quarter of 2021. This reflects continued investment across our pipeline to drive progress of our late and early stage pipeline.
SG&A expenses increased to $160 million and the first quarter of 2021.
And this reflects commercialization efforts related to the launches of <unk> seven for Kaiser and the U S as well as investments to support the launch it to Kaiser and Europe.
We ended the first quarter with $2 $5 billion and cash and investments and we have no debt.
And this positions us strongly to advance our plans in 2021 and beyond.
And lastly, our financial guidance for 2021 is unchanged with that I'll now turn the call over to Roger.
Thank you Todd and good afternoon, everyone.
And I'm happy to share today key R&D activities for our approved medicines as well as our pipeline programs.
Start today with pet sales as a reminder, passive has accelerated approval in the United States for metastatic <unk> cancer patients, who previously received both platinum based chemotherapy and checkpoint inhibitor and the.
And the randomized phase III, EV, 301 trial, which compared <unk> to chemotherapy in the setting demonstrated a clinically meaningful and statistically significant and 30% reduction and the risk of death among patients who received headsets. These data were presented at <unk> and simultaneously published in the New England.
Journal of Medicine.
The EV 301 data will also submitted to FDA and a supplemental BLA under the real time oncology review and <unk> programs and this month's. The application was accepted for priority review with a producer date of August 17.
This application seeks to convert Pat said and accelerated approval to regular approval and integrates into the label. The important overall survival data that peds and has demonstrated.
To address the potential for pets, and metastatic patient and supersedes a checkpoint inhibitor and are cisplatin ineligible we conducted cohort two of the EV 201 pivotal trial.
Positive data from this cohort were presented at the <unk> meeting in February.
Earlier this month FDA accepted our supplemental BLA to potentially expand the U S label to include this population.
The application is also being reviewed under our tool and has been given priority review with the same producer date of August 17th and abstract including additional follow up data from cohort two will be reported at ESCO and June.
Our strong <unk> data have enabled substantial regulatory progress outside of the United States in the past two months, we and Astellas have engaged with eight regulatory authorities around the world and marketing applications are currently under review, including in Australia, and Canada with Health, Canada, signing priority review.
In the EU, where the application has been assigned accelerates and assessments and importantly, this could shorten the time to approval and lastly, in Japan, Brazil, and Switzerland, and Singapore and.
And you to advance a substantial <unk> clinical development program, which includes two trials that could support approval in first line metastatic <unk> cancer.
We expect to complete enrollment of cohort K of the EV 103 trial and cisplatin ineligible patients receiving <unk> plus keytruda by the end of this year and if data are supportive and we plan to submit a supplemental BLA after appropriate follow up for duration of response. In addition, we continue to enroll patients.
And to the Phase III EV 302, global trial, which includes both cisplatin eligible and ineligible patients evaluating <unk> plus keytruda compared to a platinum containing chemotherapy regimen.
These trials are supported by initial data from the EV 103 trial, which resulted in breakthrough therapy designation updated durability results and long term outcomes from these initial data will be presented at ESCO.
As we move past <unk> into earlier stages of bladder cancer, two phase III trials are enrolling patients with muscle invasive disease, both trials utilized pads and in combination with keytruda.
The keynote <unk> trial also called EV 300 for is enrolling cisplatin eligible patients and keynote 905 also called EV 303 is enrolling cisplatin ineligible patients. Additionally, we continue to work to bring <unk> into a clinical trial for non muscle invasive.
And then the cancer patients and have completed our initial regulatory discussion with FDA in summary, we are making great progress with Tencent.
Turning now to Kaiser and the development team is advancing a similarly broad clinical program to support label expansions and breast cancer and investigate to Kaiser and other her two positive cancers and.
And breast cancer, we are evaluating to Kaiser plus CAD silo, and first and second line metastatic patients and the hole to climb to trial and.
Additionally, we are pleased to report that the first patient was recently and Roes in the randomized compass flow to our day trial being run by the Alliance Cooperative group evaluation to Kaiser Trust, KED silo and high risk adjuvant breast cancer patients.
And Gi cancers, we are on track to complete enrollment in the mountaineer trial by the end of 2021.
This trial is intended to support accelerated approval and the United States for patients with advanced <unk> positive CRC.
Also we are advancing Chicago and several exploratory studies, including in combination with and oxalic platinum based chemotherapy regimen, and first line and Gi cancers.
And a basket trial for solid tumors with social alterations that include mutations and in combination with and <unk> for her two positive breast cancer.
Moving on now to ADCETRIS, we are excited that the echelon one five year manuscript has now been accepted and we anticipate publication in the coming weeks results demonstrated robust and durable remissions in patients with newly diagnosed advanced Hodgkin lymphoma, who received ADCETRIS in combination.
<unk> was AED five years free of disease progression is a clinically meaningful and important milestone and a cancer patient's journey.
Going forward, we continue to invest and the development of ADCETRIS with several ongoing clinical trials, notably we have a randomized phase III trial in diffuse large b cell lymphoma exploratory evaluations of ADCETRIS, plus and the volume that plus a D. In frontline advanced and early stage Hodgkin lymphoma, and we are in.
Flooring ADCETRIS in combination with Keytruda, as and immuno modular tree agents and solid tumors.
Now I would like to turn to our late stage program to <unk>, which.
Which we are developing in collaboration with Genmab Elliott.
Earlier this month, we announced that the FDA accepted our BLA is seeking approval of television for treatment of women with recurrent or metastatic cervical cancer and the FDA has assigned a priority review and the <unk> action date is October 10th we believe television could make a meaningful difference to these patients where there is such a high unmet.
It needs.
We also recently initiated the innovative 301 global phase III trial in a similar population of recurrent or metastatic cervical cancer patients that is intended to support global regulatory applications and serve as the confirmatory trial and the United States.
Turning now to <unk>.
We continue to work with our partner Merck <unk> co developed Lv as monotherapy and in combination with Keytruda and live one expressing solid tumors.
Clinical development program is focused on optimizing dose and schedule as monotherapy and in combination with Keytruda and breast cancer and basket trial is also currently enrolling patients with lung head and neck, prostate softgel gastric cancer and melanoma.
Across the rest of our pipeline and I'd like to summarize a few recent highlights at the ACR meeting in early April we presented several compelling preclinical data sets without phase one clinical programs. This included SCA tickets, where we showed the enhanced anti tumor activity when combining ECA tissue with it.
Checkpoint inhibitor or overdose and based ADC. In addition, we described encouraging preclinical data with SDN and <unk> and <unk> S. T N V and both of which are novel the dose and based Adcs that have recently entered the clinic.
We also entered into a clinical trial collaboration with Pfizer and the which will evaluate <unk> in combination with SaaS and the mab.
Subcutaneous PD one inhibitor.
The combination will be evaluated as part of our ongoing phase one FCA tickets trial and advanced solid tumors and lymphomas.
And lastly, we completed enrollment and a clinical trial evaluating <unk> 40, as part of a combination regimen for the treatment for pancreatic cancer, we expect to reported clinical data from the trial sometime later this year, which will inform next steps with this novel effector function enhanced non fuel cost legit antibody.
Net buying CD 40.
In closing we have achieved many important milestones and have made significant progress across our pipeline in the first quarter of 2021, we look forward to providing you with further updates as the year progresses, and now I will turn the call over to clay.
Thank you Roger.
The past year has been pivotal procedure and and the company is well positioned for the future.
Today, we have a deep and diverse pipeline and multi product commercial portfolio and additional potential approvals on the horizon.
Additionally, we have powerful partnerships, our broad geographic footprint and substantial financial strength to maximize our assets from our early stage pipeline to our expanding portfolio of approved medicines.
And the solid foundation, we have built sets the stage for <unk> next phase of innovation and execution I am confident and our ability to continue delivering cutting edge innovation and medicines that make a meaningful difference to the lives of cancer patients.
I would like to thank everyone listening to this call for your continued interest in CGM operator, Please open the line for Q&A.
We will now begin the question and answer session.
I ask a question you May press Star then one on your Touchtone phone.
Youre using a speakerphone please pick up your handset before pressing the keys to withdraw your question. Please press Star then two.
At this time, we will pause momentarily to assemble our roster.
Our first question comes from Geoff Meacham from Bank of America. Please go ahead.
Hey, guys. This is Greg Harrison on for Geoff Thanks for taking our question.
The question is.
What sort of physician reception have you seen and with respect to Pat.
After the cases of Steven Johnson and syndrome.
And that came out.
And we've heard kols, saying it won't affect prescribing much and they can screen out.
High risk patients, but just wanted to see what you guys are hanging on your end.
So Greg Thank you for the question.
And <unk>.
Has really delivered a very strong launch with rapid penetration into our labeled indications following its approval rarity and of 2019, so really.
Full year of 2020.
The.
Concerning the day label safety is always a top priority for us.
And label updates and formed positions on what to do and how to work with.
Patients to prevent anything from happening.
Our sales reps have been educated.
Health care professionals have been updated and educated and physician sentiment remains very positive on the.
Risk benefit profile, the very positive risk benefit profile with Pat said it has not been an impediment to adoption and is a very rare occurrence and it has not changed practice and use of pads.
Roger did you want to add anything to that.
Thanks Clay so the label.
Skin reactions have been part of the pants and safety profile for some time.
And so this wasn't the importance of the post marketing observation that was just extended into the label so for.
From the beginning we message very carefully around safety it's important.
Most of the side effects are transient and reversible and we think.
It's valuable for physicians to understand this so again from a medical perspective. This does not change the risk benefit for pads. It and we believe it will continue to be used and we certainly haven't changed and you're about clinical trial plans.
Great. Thank you.
Next question comes from Matthew Harrison from Morgan Stanley. Please go ahead.
Hi, Clay and team. This is connor on for Matthew So on T. Though could you comment on the outlook for the Keytruda combination and I guess how quickly.
You could move that into a Registrational program and then quickly are you seeing any competition from true Dolby and.
And what are your expectations for the impact on that drug to Pat. Thank you.
Okay. Thank you so two completely different questions. One is on TV plus keytruda.
Let's start with that.
So we're very pleased with.
TV is moving along as we said we.
<unk> television and.
And we have submitted it and we now have a <unk> date, we have.
And with.
The accelerated approval timelines.
So we're pleased with that.
And the current therapies for metastatic cervical cancer are really poor there January with response rates of less than 15%.
And Oss between six and nine five months. So it is a significant unmet need.
Certainly in the U S and around the world incredibly significant.
And so our program includes.
Big part of it which is combining with.
Keytruda and chemotherapy, so we have multiple arms there.
And.
And Thats and earlier lines of cervical cancer and so we were very pleased with the success Theyre getting.
And getting patients to the trials and putting together a real opportunity there.
We have not presented any data yet, but the trials have been going very well and we will be and.
And appropriate time, presenting the data and information on these and making decisions to whether or not you go to a pivotal trial. It's my hope that we see great data and we go into a pivotal trial to try to get to try to get the kind of data that you could submit for earlier stage cervical cancer, which could be really beneficial to patients.
And also a.
A substantial market Roger do you want to add anything to what we're doing with TV and Keytruda right and.
So clay exactly as you say, we have a monotherapy path for approval, which is currently under review and that same monotherapy and late line cervical cancer with a global trial that is running.
But of course, our interest is and combinations as well in order to move into earlier lines of therapy, and I think we're well positioned with regard to the way.
We're evaluating combinations of chemotherapy and keytruda such that if we do get positive Readouts, we can take those combinations forward into further clinical development.
So your second question, it's about competitive impact of <unk>.
First of all I want to say that we are very pleased that there are more options for patients we are very patient for.
Company and think about how best.
Providers and doctors can treat patients with life threatening diseases. So.
Is it more the better for patients.
And second of all Pat said this become the standard of care and its approved indications.
And it's really firmly entrenched in the metastatic your appeal setting.
Post platinum post PD, one and <unk> has shown OS benefit.
And it as well.
We're very pleased with where pads have is in the lineup and Roger you may be able to discuss any updates or thoughts can connected with us.
Sure so.
As clay indicated the more treatments that are available for patients the better.
However, the pensive program, which is substantial.
Has already created.
Yeah.
And the use of pets is in a specific line of therapy.
And it is as you say essentially a standard of care, which is difficult to displace. So we're glad that <unk> is there. However, we do see pads have have having a very strong.
Very strong value proposition.
Okay.
The next question comes from <unk> Richter from Goldman Sachs. Please go ahead.
Thank you and maybe just a question on to Kai thanks for United.
Got it.
A life product and second line positive hurricane and positive patients with brain Mets can you just comment and what you're seeing and the same setting in patients without brain Mets.
Sure. So thanks for the question on <unk> as you know to Kaiser is approved for patients.
With visceral disease as well as patients with brain Mets and we are certainly.
Using it in both patients and getting a lot of uptake there.
Chip could you comment a little bit.
The dynamics and the market of using <unk> and.
Brain Mets and and patients with visceral disease.
Yes, thanks clay very much. So we're pleased with the progress that the case is making we're seeing both increased utilization in patients with and without brain metastasis, So and as I mentioned earlier and the the reading more and although the most used product and second line and beyond for people with brain Mets. So.
Again uptake has been robust.
This role and that's as well and it continues to grow.
Thank you.
The next question comes from Cory CASM off from J P. Morgan. Please go ahead.
Hey, Good afternoon. This is Turner on for Cory. Thanks for taking my question. So just one on the phase one FCA CD 40 study and you know us.
You mentioned in the prepared remarks enrollment completed with around 159 patients across a bunch of different tumor types can you just give us a sense of how many tumor types smoothed into expansion cohorts or was it just pancreatic cancer and.
And also just assuming you see signals with indications like pancreatic later this year, what do you see as potential next steps.
Sure. So I have and previous calls talked about my interest and.
And working on pancreatic cancer, it's just such a huge unmet medical need and how that's something that.
Felt.
As a cancer biologists to sell and making cancer drug.
And I was really hopeful that we can make an impact in pancreatic cancer patients. So certainly thats been an important part of this study Roger can you talk a little bit about where we are with SaaS.
<unk> 40 and our.
Our plan and later on this year, we are planning to have data, we I think we committed to.
Presenting data for <unk> 40, sometime this year and now that does not mean that we're going to wait to making programmatic decisions pillar data as presented we can make programmatic decisions editing time and meet with regulators and any time and try to go forward on this.
And <unk>.
Merging exciting program, but Roger can you talk a little bit about what we're we're looking at in our arms before making any decisions on them.
And pivotal trials for sure.
So the CD 40 program began as essentially a monotherapy program.
We have and active agent we have responses based on mono therapy.
We then pivoted the program for monotherapy into a combination approach and that initial focus is and pancreatic cancer. So.
As clay alluded to we are interested in testing CD 40, plus chemotherapy.
Plus a PD, one inhibitor and frontline pancreatic cancer and that's the data that we will be focusing on however from a biologic and sort of scientific perspective, we.
And are interested in the construct of combining a CD 40 agonist together with some form of cell, killing through chemotherapy together with a PD. One inhibitor. So we are working on plans potentially to look at other possibilities for further CD 48 development, but the initial focus in the combination.
Space is pancreatic cancer.
Thanks I appreciate it.
The next question comes from Michael Schmidt from Guggenheim. Please go ahead.
Hey, guys. Thanks for taking my question I had another one on the early stage pipeline and specifically on the kitchen antibody it looks like other <unk>.
Body.
Antibodies have had rather was similar.
And the agent activity and phase one studies.
Few anecdotal responses seen that I guess to.
To what degree would you expect and antibody like yields with enhanced effector function to potentially improve upon these competitive molecules.
So thank you for the question on our SCA ticket. So we were just studying it now so we've not reported any data at this point.
But pre clinically we saw that we had a very high effector function because it uses our <unk> technology, which we've talked about before how that augments.
Her function, while decreasing the inhibitory effector function. So I am not going to go through all of that again since I talked about it a lot.
We are very excited to take our drug into clinical trials. The hope with any drug is to see single agent activity and then the hope with any drug is that not only does it work in single agent activity, but it works and combination and so we have.
A lot of plans for what to do and combination with PD, one inhibitor and with a single agent and so we're working on advanced solid tumors and lymphomas and we are we're cranking forward and so I look forward to a time, where we're presenting data.
Okay. Thank you.
The next question comes from Andrew Berens from S&P SBB Leerink. Please go ahead.
Thanks.
I wanted to see if you guys would give us some color about it.
Presentation, I guess it was cohort K, that's going to be and IOSCO, who will be a larger sample size and what you presented previously or it'll be the same for 45 patients for the longer follow up.
Uh huh.
I'll turn it over to Roger for that Roger how about you addressing that.
So Andy Thanks for the question essentially cohort a.
So it's the it's the original data set some 45 subjects.
We saw that initial remarkable signal.
And the data we've presented has been mature, it's even more mature and now and we're excited to bring that forward. So you can see what the long term outcomes look like with this combination of pets, and <unk>, plus keytruda and cisplatin ineligible patients with.
Frontline metastatic <unk> cancer.
So it's not cold kits cold day.
Okay. Thanks I appreciate it.
Yeah.
The next question comes from Kennan Mackay from RBC capital markets. Please go ahead.
Hey, guys congrats on the quarter.
And elaboration on a prior question and then a separate question Roger and Clay you had mentioned completing that.
For the 40 study and.
And pancreatic cancer data later this year and so quite how it seems like you're excited about this one but just hoping you can personalize and little bit more.
He is a win here as being stable.
Stable disease enough to get excited.
Pancreatic cancer, given the huge huge huge unmet medical need.
You mentioned or do you really need to see responses to really help conviction there and then.
Just on pads and wondering if.
And you could help us with the breakdown of the bladder cancer market and the incremental size of that metastatic and locally advanced bladder cancer market that was previously treated with a PD one PDL one but in eligible for cisplatin and just trying to think about the incremental add from that.
But we're expecting to come online later this year. Thank you.
Sure why don't we start with the bladder market and chip can you talk a little bit about the question, Ken Ken and asked about what we can expect with the potential additional market.
Yes, absolutely close so this is a smaller segment of the population, but nevertheless, I think a meaningful number of patients. There is an important unmet need given these are typically older patients they suffer for multiple comorbidities like.
For kidney function, we are already seeing some unprovoked utilization, but we think there is a remaining opportunity once we get label to promote too.
So going to your question and pancreatic cancer Kennan.
No.
There are a lot of things you can look at now the study we are.
Enrolled and we will be presenting data on.
Will provide us a lot of information on or are objective response rate and just for reference.
<unk> <unk> is about 23%.
In their phase III and.
And.
So.
If we come in with 24%, it's not going to be meaningful so it has to be substantively above the 23%.
Second of all we want to look at the duration of response, we do that with every drug we do whatever disease. It is we look at duration of response and you don't want a duration that's super short because that doesn't really help patients and it's not that meaningful and the regulators also want to see duration. So we want to see it for ourselves and this.
Our lead in trial and then.
The other thing is we want to.
Try to take and initial look at saying what is can.
Can we learn anything about OS and it's not a randomized study it's not that would be the next study, we get but digital very well cataloged information on pancreatic cancer and what Oss and so we think we we.
We.
We'll get a handle on that and be able to say, okay. We have.
Or are we have duration and we have some trends.
And because it's not going to be statistically meaningful two arm data that would happen next but we'd have trends there and we saw these kind of things and other drugs, we developed and it's important to look at them and say how are you doing and all these really critical datasets and that's what we've been doing and I have gone on record, saying I am really.
Interested and this and excited about what we're seeing initially.
To that extent, we publicly said, we're going to expand what we're doing.
Pancreatic cancer, a lot of people and history have seen data on a little bit a few patients and have been and.
And once you go to a lot of patients it hasnt really panned out so we're trying to be appropriately.
Studying this to know.
And a expanded population from our initial.
Evaluation it will the data hold will be exciting and should we go into a pivotal trial with it and this is something is the way we develop many drugs and so this is not unique to <unk> 40. This is something we've done with other drugs and expanded what we've done and get a really good handle and I think that by doing.
These expansion.
Studies of single arm studies.
Your hit rate of phase III and randomized studies is much higher and I think that our hit rate historically has been high once we get some additional conviction based on a little bit bigger study and not just a tiny study. So that's what we did with this we had a very small amount of data we were.
Speaking for myself I was excited with it.
But I and the clinical team here wanted to really be sure of what we're seeing so that's what the data that will come out as Roger do you want to have any comments on this.
And I think so it is a single arm experiments and obviously the key points are and exactly as you say, what's the range of response, what's the durability of those responders what is progression free survival and look like and what is overall survival looked like and there is a very clear record of what.
And what to expect with standard chemotherapy. So hopefully if we see positive data will we'll be able to make some decisions about what a potential next step could be.
Awesome. Thank you guys. So much that's really very helpful and it does sound like something to be excited about.
The next question comes from Gena Wang from Barclays. Please go ahead.
Hi, this is shutting down for gena. Thanks for taking my question.
Maybe just one quick question about the Takeda for lunch.
In Europe.
Good to hear that you have launched in Germany, France and Austria.
And what do you see the potential ramp up there over the course of next.
A year.
How many additional markets.
What do you expect to enter.
And it also and a related question and I'll pass it.
And our European launch.
So do you expect the launch pace to be roughly the same.
So first of all thank you about the Kaiser question about Europe. We are very pleased with our progress to Kaiser has now approved and 36 countries countries worldwide and that includes the EU and the U K.
We have general managers and the major countries. They are building teams. They have deep industry experience. We have done commercial launches now as we've said and Germany and France within one month of the EMA approvals for that's brand new.
We are working to make <unk> available as quickly as possible and feasible and all the European countries.
We have to navigate the local HCA processes. So that takes time and they don't all come on at once I mean this is.
A little bit of a different process and in the U S, where you could say that once the U S approvals all states are approved but in Europe.
You have to go one at a time at a time and we don't we don't just do them sequentially. We're working on at the same time, but it still is not all.
And then with regards to the UK, we are actively engaging with the organization called nice with a decision expected in the fourth quarter of this year so very.
Very big efforts to get it into all these countries with just a few of the countries recently.
Having commercial launches and so right now we expect the majority of <unk> revenues come from the U S.
And.
And that's what we are for now but in the future, we expect more and more to come from Europe.
Okay.
The next question comes from Stephen Willey from Stifel. Please go ahead.
Hi, This is ellen on for Steve.
And I understand the cat and everything and about vitamin and combination and her two and hurt your climate for for so I'm good.
Just curious what the bar for success is there and maybe how you are thinking about the safety profile of this combination.
Sure absolutely.
We think that to Kaiser is a great drug to combine with and use and a lot of different regiments. Roger can you talk a little bit about what youre thinking with <unk> or.
For two.
Yes.
So both drugs are highly active and obviously combining active drugs in oncology is a a potentially fruitful path in terms of trying to find effective combinations and just bear in mind, because and her two is trastuzumab plus chemotherapy.
Essentially the same sort of conceptual construct as was and how to climb will be combined to cabinet with trastuzumab and chemotherapy, which is Cape side have been.
So it's following the path frankly that we are taking with to cap them and multiple other places where we're using to captive and combination with <unk> I don't think we are setting the baas, we need to explore.
And we will see once we have some data to hand, we can determine.
What what potential value that regimen may have its combination.
From a safety perspective, again, I don't think we have any expectations, one way or the other and then.
And I think we're expecting amplification of safety from either side, but we need to generate the data and then we can evaluate.
Okay, great. Thanks for taking my question.
Next question is from Andy share from William Blair. Please go ahead.
Oh, great. Thanks for taking my question.
So I'm just wondering if you could elaborate on your strategic positioning for SG and CD 30 day.
Would that be kind of and improved product to the medical community or.
You would be exploring areas where.
And you haven't or basically are not.
Yes.
Amenable to.
To be targeted by by et cetera.
So I appreciate very much. The question, we definitely have second generation molecules that we're working for et.
Et cetera is actually a few of them that we're working on and.
One of them, we call C. As you referred to but there are some different molecules quite.
And quite frankly, they're all exciting it would not be.
Impossible for us to take more than one.
Two phase one study and compare them there and then decide which one to go with so I don't want to rule that out either.
There are some technologies that I'm not at Liberty right now to explain exactly but.
I think are exciting and I have a unique perspective, and having been one of the pioneers in this field and building it up and the fields now really taken on a life of its own and it's a lot of companies now work on Adcs.
And I look in the past and.
Some of the Adcs and how they were made.
With bad linker, and natural product drugs and I call that 1.0, and then there was.
Better drugs synthetic drugs and much better linker.
Or in drugs, like et cetera, and passive and Palo Verde from Roche and.
And others, and so I call that adcs.
To point out if you will and then how will we get as a field to adcs three pointed out and what can we do and what are the technologies that are needed to continue improving the efficacy and patients and decreasing any of the side effects that you have and that's always the goal or what the docs say.
Getting a better risk benefit ratio and how can we do that and what can we do so we have spent many years pioneering some new technologies that we have and I am really jazzed up about these new technologies based on all of their preclinical data and efficacy and safety, including non human primates. So I think what youll see from us.
US is.
Another generation of new Adcs debt.
And may have different payloads different linker and different ways of thinking about how to do these different toxicities or lack thereof, and those are coming. So we are we are working hard on ADC three point out so stay tuned we'll be talking about and as soon as it's appropriate to.
The next question comes from Jay Olson from Oppenheimer. Please go ahead.
Oh, hey, thanks for taking the questions and congratulations and all the progress and.
And do you have and October produced for TV can you talk about some of the work that you've done to prepare for the launch including anything on reimbursement and our treatment guidelines and then separately as you look across your broad.
<unk> portfolio and pipeline do you see any gaps that you want to prioritize for business development purposes. Thank you.
Okay. So the first question is on television and launch and reimbursement and all the rest.
We certainly have submitted and we're certainly working with regulators on this we have a <unk> date.
We're working on combinations with Keytruda and with chemotherapy, we've talked about that already and the call. So there's a lot going on debt.
We work on.
And we will continue to work on before and in front of our <unk> date of October 10th and.
But we're really excited that this could be our force drug and we think it's something we understand we know how it all help patients. The confirmatory study is continuing and with planned enrollment and the U S and abroad and.
Certainly when you look at the commercial planning we will go ahead and.
And make sure that this gets launched really well, we're working with our partner Genmab on this chip do you want to have a brief comment I don't want to say too much about this it's a little early and it's.
It's also.
I don't think we want to outline too much yet we're just got only a few weeks ago, we got accelerated.
Status for approval, so I don't want to get.
Ahead of where we are but chip can you give some general comments, yes, sure clay absolutely so.
We have key personnel and the commercial organization in place they've been in place for some time now and then.
And working to make sure that we're launch ready by the time with a <unk> date like Clay mentioned, we're looking forward to co promoting this with Genmab and we will also pull and some of the best practices that we've had in the pads and then to queso launches.
The next question comes from Ren Benjamin from JMP Securities. Please go ahead.
Hey, good afternoon, guys. Thanks for taking the questions.
I guess minus regarding the non muscle invasive opportunity can you maybe provide some color regarding the.
Discussions with the regulatory agency and the trial is planned for BCG unresponsive patients, but do you have any thoughts on moving that either in combination or potentially for planting.
Okay.
Sure. Thanks Ram for the question Roger do you want to address what we can talk about now sure.
Sure so.
Non muscle invasive bladder cancer is a is a large.
A large unmet need as you pointed out BCG unresponsive as the place to begin.
But depending upon what the product's profile looks like in terms of its efficacy and safety.
It's always a possibility to consider combinations and a lot of folks are going with combinations with BCG or potentially looking for.
A new gold standard.
What's attractive about pad sales in terms of its possibility and it is just at this point and to possibility.
Is that in the preclinical experiments that we've done we have almost no systemic exposure and that's an important part of the equation for patients who.
And I'm, not going to die and necessarily of the bladder cancer, but needed to be managed and try and potentially to avoid things like surgery.
That's the one point the other is debt target pads.
Is going after which is net in for.
And is highly expressed not only and the advanced and metastatic populations and and muscle invasive, but non muscle invasive as well.
So we have an opportunity to instill pads for a test.
<unk> Pan safe to see if we can gain control for us of BCG unresponsive and then if we have a strong if we have a strong.
Positive.
Benefit risk that we would like to take forward, yes, we would clearly want to develop it further.
Perfect. Thank you.
The next question comes from.
Sean Zhou from Wehrenberg. Please go ahead.
Hi, Thanks for taking my question I have a quick one on your CD 40 antibody and.
And can you talk about the biology.
That.
Target debt why what are you seeing your sugar engineered FC and anybody can work better than other antibodies.
I think for you.
Seems like the side effects could be the issue I guess why do you think ft and.
Okay, and then maybe avoid debt problem. Thank you.
So I'm not exactly positive how to address this but.
What we're looking at is trying to enhance the activity that you would get through effector function and also decrease the inhibition that you get.
And when you look at.
And no PD ones. They released a break on T cells. So it's a very fine balance between getting more activity.
And releasing inhibition and we think that our SBA technology does have some properties that no one else has and we've observed them.
In preclinical models and we've talked about them a lot and so we're really excited about it now the proof is in the putting we have to go and we have to test this and humans to have cancer and see what we obtained both on safety because we're very very.
Cautious about making sure we're safe and patients and and really transparent about that but also in efficacy and seeing what happens and in addition to working with this as a single Inc.
There's a lot of.
Going on to bring it in combination and that's something with the PD, one inhibitor and Thats something thats important as part of the day trial. So we're bullish on the molecule. We're bullish on our technology and we're hopeful, but we're not ready to discuss and present the data.
Thank you.
The next question comes from Brad <unk> from Credit Suisse. Please go ahead.
Thank you I wanted to ask is some of the moderation and the paths of sales growth over the past few quarters due to patients being too sick to continue to a third line therapy and not getting the opportunity to try and pads and.
And more broadly clay, how do you think about the low systemic treatment penetration and metastatic bladder cancer overall, and then maybe how passive can change that when it gets approved and earlier lines.
Okay. So these are <unk>.
And I certainly won't ship too.
To comment on Chip would you do you want to see.
What do you how you can answer this yes, absolutely. So it's not uncommon at this stage of a launch to see product growth begin to decelerate patch is a standard of care. We are very optimistic about the changing market dynamics and.
And this marketplace PD ones and PD L ones have moved up utilization into the frontline. We think that's going to continue in 2021, which will provide pads and opportunities to increase the treatable patient population.
Okay.
There are no more questions and the queue. This concludes our question and answer session I would like to turn the conference back over to Peggy Pinkston for any closing remarks.
Okay. Thank you operator, and thanks, everybody for joining us this afternoon and have a great evening.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
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