Q2 2023 ADC Therapeutics SA Earnings Call
Hello, and welcome to the a D C Therapeutics second quarter 2023 financial results Conference call. My name is Corey and I'll be your operator for today's call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session. During the question and.
And the answer session. If you have a question. Please press star one one on your Touchtone phone to withdraw your question. Please press star. One again, please be advised that today's conference call is being recorded I would now like to turn the call over to Eugenia lifts widespread.
Investor Relations and corporate Communications you may begin.
Thank you operator. This morning, we issued a press release announcing our second quarter 2023 financial results and business update.
This release is available on the a D C. P website, and I aren't that ADC therapeutics Dot com under the press releases section.
On today's call are need Malik Chief Executive Officer, Christian Harrington Smith, Chief Commercial Officer, Bahama, Darkey, Chief Medical Officer, and Pepe Carmona, Chief Financial Officer, who will discuss recent business highlights and review our second quarter 2023 financial results before opening the call for.
A question.
We begin I would like to remind listeners that some of the statements made during this conference call will contain forward looking statements within the meaning of the safe Harbor provision of the.
U S Private Securities Litigation Reform Act of 1995.
Samples are forward looking statements include those related to our future financial and operating results.
The impact of our updated strategic plan forward, including our commercial field strategy.
So Leo prioritization and capital allocation and restructuring plan, our ability to achieve our guidance for 2023 with the launch of revenue and operating expenses as well as our future cash requirement projection.
Revenue growth market acceptance competition and volume growth for our products.
Launches and market share for our products either alone or through our foreign partner.
And results of ongoing and future development programs and clinical trials for our product either alone or in combination with our partner product.
D E and for regulatory authorities actions and potential regulatory approval for our product.
Either alone or in combination with our strategic partners products future strategic partnership and business development efforts, our ability to repay our outstanding debt obligation and future access to capital.
These forward looking statements are subject to certain risks and uncertainties and actual results could differ materially they are.
Identified and described in today's press release and the accompanying slide presentation on slide two and in the company's filings with the SEC on form 20-F.
And as updated and ATC Ts recent periodic filings on form 6K.
A D C. T is providing this information as of the date of today's conference call and does not undertake any obligation to update any forward looking statements contained in this conference call as a result of new information future events or circumstances. After the date hereof, except as required by law or otherwise.
Got.
The company cautions investors not to place undue reliance on these forward looking statements.
Today's presentation also includes non <unk> financial measures. These non <unk> measures.
Limitation as financial measure and should be considered in addition to and not in isolation or as a substitute for the information prepared in accordance with Ifr at you should refer to the information contained in the company's second quarter earnings release for definitional information and reconciliations.
Historical non <unk> measures to the comparable <unk> financial measure.
It is now my pleasure to pass the call over to our CEO , Amit not like me.
Thank you Gena and thank you all for joining us it's my pleasure to provide an update on our progress during the second quarter.
Starting with the market, we delivered net sales of $19 2 billion up 11% year over year.
The growth was slightly offset by higher gross to net including the new Medicare discarded drug policy and GPO contracting.
Compared with the prior quarter dollar sales were up slightly and volume grew by just over 3%.
Importantly, during Q2, we implemented a new commercial go to market model to better align with local health care ecosystem and the evolving treatment dynamics.
We completed the staffing of the organization by the end of June and we expect to see a progressive benefits from these changes in the coming months and the exit 2023 with a healthy run rate.
As for geographic expansion, our partners that will be completed the first European commercial sales in Montana with the launch in Germany.
This triggered a $75 million milestone payment under our purchase and sale financing agreement with healthcare royalty partners.
In China, and MPA accepted the BLA submission person locker and granted priority review.
Finally in Japan, our partner Mitsubishi Tanabe initiated the phase one two bridging study.
Turning to our clinical development program for as a marker we proactively took the tough decision to discontinue the phase two lotus non clinical trial.
As we did not see a clear regulatory path forward.
This is an example of our data driven approach to clinical development decisions and our disciplined capital allocation strategy.
We are nevertheless, disappointed that we are unable to offer these patients a potential new option.
Separately, our ongoing phase III <unk> confirmatory trials in Montana, and Rick talks about it.
In second line second line plus <unk>.
And our phase II <unk> clinical trial of the market in combination with Biospecifics continue to progress as planned.
As a reminder, both of these trials include very different patient population should be by this time.
Turning to the remainder of our pipeline, we enhanced investments and our focus portfolio during the quarter, taking the opportunity to accelerate and expand our prioritize development programs.
As a result, we look forward to several potential value, creating data readouts in the next 12 months.
In particular, we expect to share initial phase one data from <unk> 601, targeting actual and from ADC <unk> hundred one targeted CAG one we.
We also expect to share additional phase one data for <unk> 602 targeting CD 22.
To summarize the quarter overall I am pleased with how we executed on the new corporate and capital allocation strategy, we announced three months ago.
Our new commercial model is now wrapping up our pipeline has potential meaningful catalysts over the next 12 months.
And our expected cash runway continues to provide us with the ability to execute on our business plan.
I remain confident that we're on a path to unlock a tremendous value.
My executive team and I see in the coming months and years.
With that I'd like to turn the call over to Christian for a commercial update Kristen.
Thanks, Amit It is my pleasure to share an update on the Atlanta.
As you already heard second quarter net sales of the Monza grew 11% year over year and were slightly up sequentially. Despite gross to net headwinds.
Keep in mind two important factors.
We had significant disruption in the field during the quarter as we implemented our new go to market model, which was staffed by the end of June .
And second the competitive landscape continue to evolve during the quarter with the entry of two by specific.
As <unk> stated, we have been working hard to implement our new commercial model.
Acknowledging this was no small undertaking and recognizing that there would be fairly significant disruption along the way restructuring the field force was critical in this increasingly competitive environment.
This was done with a long term view in mind.
To optimize the uptick in the third line third line plus setting and to put in place the foundation for future growth and potential earlier lines of therapy I.
I am confident that we now have the right structure and tools in place to drive and lots of forward with.
It was approximately half of the field force newly hired or in new roles. We came together at the beginning of July for our National sales meeting to align as a team and.
And I am proud to say that our newly deployed field force left this meeting energized engaged and ready to compete now and in the future.
As the team ramps up under the new model, we expect to see a progressive improvement in lots of demand during the second half of the year.
We will continue to focus on top accounts in each geography, while driving influence and pull through to the community.
Wariness still lags that of other novel agents and there remains significant untapped potential.
As a reminder, we have realigned to smaller local teams based around two key roles.
An account manager with experience in navigating complex institutions and two hematology specialists focused on the community centers.
As the landscape evolves, we continue to believe that's been Alonzo has a clear long term role to play in the treatment of third line third line plus D. L Bcl, which I remind you is a highly fragmented market with no standard of care.
And these positions have been slow to adopt newer therapies and continue to use older Rituximab based regimens.
With respect to the recent launch of bi specifics there is clearly some excitement about used in monotherapy, particularly in the academic setting.
They are working to determine the appropriate patients for these products given their efficacy, but also the unique safety profile with potential Crs and ICANN and the recommendation for inpatient administration.
Team is focused on ensuring thought leader advocacy and reinforcing the unique clinical attributes of <unk> to help drive long term growth.
We believe <unk> is ideally suited across different treatment settings, particularly the community given its durable efficacy.
Short time to response manageable safety profile with no Crs and simple dosing without rems or inpatient stay recommendation.
In fact recent data from EAA and ICL reinforced the durable efficacy of the Atlanta in a heavily pretreated patient population.
Specifically, we reported at the two year follow up the median duration of response was not yet reached for patients who achieved a complete response.
As we deliver improved execution with our new commercial model. We believe we are poised for growth and our longer term opportunity remains unchanged.
We expect the launch of the exit 2023 with a strong run rate setting us up for success in the years ahead.
With that I'll turn the call over to Mohammed.
Thank you Christie.
It is my pleasure to share an update on the pipeline.
Over the last quarter.
The prioritization of our R&D pipeline, we have being able to focus our efforts and resources on our more advanced programs, which we believe have the highest potential to drive value.
Sure.
As mentioned, we made the decision to discontinue the <unk> nine study.
While this is disappointing to all of us at the company and in the treatment community I strongly believe it was the right thing to do.
It is important to note that the treatment emergent adverse events and Lucas Zion.
<unk> see it in other studies was the launch to date.
Including monotherapy trials, one and two.
In addition, they do.
I didn't see any views on blinded data noted at our regularly scheduled meeting in late July .
Study should proceed as planned.
We also recognize that the lupus and lupus five trials.
Very different patient populations.
We continue to expect completion of enrollment in both the supply next year.
As a reminder, this trial examining the combination of the loans that Andrew talks about.
In second line, plus DLP bcl patients not eligible for transplant and has produced early encouraging data there.
The safety lead in that that was released at Soho place in 'twenty two.
And we expect to provide an update at a medical meeting in the second half of the year.
Moving to north of seven.
This is our studies exploring novel combinations of the debt.
<unk> bio specifics, you'll see the map and most interested in that.
<unk> or refractory non hodgkin lymphoma.
Here, we see the potential for significant patient benefit.
And if successful we believe that the seven could change the non hodgkin lymphoma treatment paradigm.
In the future. We believe novel novel combinations will be the cornerstone of non Hodgkin lymphoma treatments in place.
Systemic chemo treatments.
In terms of hypothesis, we know malignant yourself.
Three broad ecosystem expression of <unk>, which is targeted by the two rush by specifics and she's AEP, which is targeted by the lump.
Consequently, we believe that combining the Atlanta with either one of the bio specific antibodies.
Has the potential to have additive or even synergistic efficacy as well as manageable toxicity in.
In patients with relapsed or refractory non hodgkin lymphoma.
Our excitement at this novel approach is also reflected in the physician community.
Which has shown a high level interest to explore these combinations.
We continue to expect to share early data from Lucas seven next year.
I would also like to note that beyond our own clinical studies, we are encouraged to see substantial interest in the investigator community.
Claude as Atlanta in novel combinations and across multiple types of B cell malignancies.
Turning to the rest of the pipeline.
Sure.
Starting with <unk> 601 targeting XO.
<unk> is a validated target that has been shown to be well suited for an ADC approach.
We have successfully amended the phase one study of <unk>.
601 to focus on monotherapy treatment for patients with sarcoma and patients with non small cell lung cancers.
Patients are currently being treated in the phase one study and the maximum tolerated dose has not yet been reached.
In parallel we are working towards Finalization of an IFC I'd say for a possible biomarker approach.
As we have previously indicated.
Initial data from this phase one trial expected in the first half of <unk>.
Turning to E DCT 91 targeting tag one.
This is in novel first in class, Egypt that target various solid tumors.
The protocol amendment to explore different dosing schedules has been finalized and submitted to regulatory authorities.
We plan to advance to the next dosing level.
As with 601.
We are completing validation of the IHT essay and we expect to share initial data in the first half of 2024.
Finally.
I would like to discuss the <unk>.
He is the one study which targets <unk> two in patients with relapsed or refractory acute lymphoblastic leukemia.
As a reminder, we are conducting this program in collaboration with MD Anderson Cancer Center.
The trial is ongoing.
As new clinical trial sites.
Have been selected to help exited at all.
Encouraging initial data that was presented at Ash in December 2022.
Which Sean MRV negative complete responses in highly refractory patient population.
As we have previously highlighted we expect additional data from the phase one study of $6 2 million to be shared in the first half of 'twenty 'twenty four.
I look forward to providing further updates on the progress of our pipeline over the coming months.
With that I will turn the call over to Pepe to give a financial update.
Thank you Mohammad.
Before I review the financials for the second quarter I want to provide an update on our efforts to increase operating efficiencies.
Over the past few months, we have reduced external expenditures on vendor procurement and consultancy and we have prioritized our pipeline.
We also reduced the workforce across the company by approximately 17%.
While maintaining a relatively stable ship and our customer facing footprint behind in London.
Taken together.
We expect this organizational efficiencies will help ensure that our operating expenses remained below 2022 levels.
Both this year and next despite enhanced investment in our focused portfolio and Mohammad described.
Going forward.
Our decisions on the development of our pipeline will be data driven and we will continue to be disciplined with our capital allocation.
We believe these initiatives will ensure that we maintain our cash runway to mid 2025.
Turning now to the financials for the quarter, starting with our balance sheet as of June 30th we had cash and cash equivalents of <unk>.
<unk> hundred $47 $5 million, representing a $37 million increase from our position at the end of the first quarter.
The increase reflects the receipt of a $75 million milestone payment from healthcare royalty partners on their first commercial sales of <unk> in Europe by our partners.
Moving to the P&L as Joe already shared.
<unk> sales were $19 2 million in the second quarter.
11% versus Q2, 2022, and slightly ahead of the prior quarter.
Moving down the P&L our.
Our combined operating expenses on a non <unk> basis, which excludes stock based compensation were down 20% compared to the same period in 2022.
This mainly reflected the operating efficiencies I referred to earlier together with a reduce R&D expenditure due to the discontinuation of a number of clinical studies in the prior year as well as fluctuations in our share price.
Commercial expenses and launched our broadly maintained year over year.
A reminder, you can find the reconciliation of <unk> forest measures to a non <unk> measure.
Mining financial tables of the press release issued earlier today and in the appendix of this presentation.
Moving to the bottom of the P&L.
On a <unk> basis, we reported a net loss of $47 1 million for the second quarter or.
58.
Our basic and diluted share.
Finally, I would like to share some potential value driving milestones, which we expect over the next 12 months.
Starting with the long term, we expect double digit growth this year and to achieve commercial brand profitability.
This means that by the end of 2023, the <unk> will start to pay in part for the development of new indications and the pipeline.
We expect to share updated data from the safety lead in portion of the confirmatory phase III not as five study in the second line setting at a medical meeting later this year.
In 2024, we expect to complete the enrollment of lot of five and we also expect to share. Some initial results from our north of seven study.
In terms of the pipeline in.
In the first half of 2024, we expect to share initial data from ADP 601, an ADC D 901, and additional data from the phase one study for <unk> 602, So we anticipate a number of important milestones, both forcing lumper an hour.
Pipeline.
With that I will turn the call back to Amit for closing remarks.
Yes.
Thank you Kristen Muhammad pathway to conclude we are confident we have a clear roadmap as well as the capabilities to execute on our strategy to help drive future value creation for all our stakeholders.
We're excited about the future and look forward to keeping you updated on our progress.
Now the team will be available for questions operator.
Operator.
Thank you we will now conduct a question and answer session. As a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.
Please standby, while we compile the Q&A roster.
Yes.
Our first question comes from the line of Kelly <unk> of Jefferies. Your line is open.
Alright. Thank you for taking my questions. The first one is on the commercial side as your cautionary launching go on do you think the region is more restrictive on the use of car T and the best practice of Canadian mutual higher drug price and do you expect Chinese demand to peak penetration in the long term.
Exceed what is in the U S.
Okay.
Thank you Kelly I appreciate the question.
We do expect there to be some more limited penetration of car T. As we've seen to date in Europe than in the U S and I would expect the same to be the case for bi specifics.
Also when you look at it just from a pure volume standpoint, the market actually in Europe is slightly bigger so overall the volume opportunity. We believe in the long term. There is a marker is even more significant in Europe of course, there's pricing differentiation.
And pricing will obviously be market by market basis, and will be lower than the U S. In general in Europe .
We expect to launch to be sort of progressive in Europe because.
As you heard in the second quarter. So it will be launched in Germany is starting to launch it in a number of other countries, particularly in northern Europe reimbursement of course is a country by country.
Coors on a country by country country basis, and so that will occur over time and over the course of the next year Progressive agree Toby one launched in more countries over the course of Europe .
Thank you and also for the second half of the year do you expect that goes to net orders being stable all continue to increase.
Good question Im sorry, I Couldnt hear you Ken Thanks for the question.
We expect to be reasonably stable, there's going to be always fluctuations depending on the mix some vessels.
And how.
Prior accruals behave.
Estimated.
Jenny.
Yes stable gross to net over the year.
Great and then lastly on the pipeline for six or 901.
So now the data will be Inc. First half for next year and should we expect the data at a medical meeting also press release and also fall.
One could you remind us.
What triggered the protocol amendment and could you also elaborate on how this will impact clinical outcome. Thank you.
So the first question regarding when did we announce we haven't made that decision.
<unk>.
On how Theyre Govind dataset.
And the timing of that so.
So we will update the market as we can.
All forward.
We will be obviously transparent and share all the data we have at the time of disclosure.
And then Mohammad you want to take the second question on <unk> on the on the reasons for the Protocol Amendment.
Yeah.
There's three main reasons for the protocol Amendment.
Tourists to proactively satisfy the requirements of project Optimists.
With relation to the FDA.
Also to improve patient experience and increase probability of success in targeting tag one in a clinically effective way.
The phase one study protocol amendment explore different dosing schedule has been actually finalized and submitted to the SBA.
And will be submitted shortly figured that theory of it is in Europe .
Once approved by the IRB is the company plans to advance to the next dosing level.
Ill also add that as an immuno immuno assay identify the validation and could possibly be used for patient selection.
If we see the need for that.
Thank you very much.
Thank you one moment for our next question.
Yes.
Our next question comes from the line of Gregory Windsor of RBC capital markets. Your line is open.
Hi, Thank you so much for taking our question. This is so powerful for Gregory.
I'm most curious about.
The commercial <unk> strategy would.
We got two dynamics with Bispecific <unk>.
Do you anticipate having more of a head on competition with bi specific or do you see that then.
Fragments of the market that flex up for grab and less competitive.
And I have a follow up.
Okay. Thank you for the question.
Yes, so we saw both bi specifics launch in mid to late Q2 and has been negligible impact for us in the second quarter.
Since then we have heard of some excitement from the physician community.
Really believe that by specifics will be limited to the academic centers consistent with our long held view based on the safety profile and the recommendation for inpatient administration.
For us.
The key opportunity for the month or the untapped potential is really driving growth in the community in.
In the long term of course.
We're excited about the opportunity to possibly combines alongside with the bi specifics to that.
A distinct mechanisms of action as well as non overlapping toxicity profile.
Got it. Thank you and then my second question I'm just curious.
If you can comment on whats the percentage.
Patients will receive salons that have been previously treated with CD 19 car T I've.
I'm just curious because.
If there is any preference for a different target <unk>.
Basically thank you.
Okay.
Sure. So I don't have the exact percentage.
I can say that in the academic centers and we ask physicians.
They're ideal patient types for the Atlanta.
Sure.
Majority of it is the post car T patients because they do see the efficacy and it's an option for those patients.
They're concerned about 18 19 to CD 19, we haven't heard that yet yes, no I agree I mean, I think if you look at as very different dynamics, playing out in the academic and community setting obviously in the community setting most of our third line third line plus users is not post car T. Because car T is much more limited in that setting.
So it's after a number of other different therapies in the academic setting the majority of our users post car T.
Just given the penetration of car T that has increased in the second line setting.
Got it thank you so much.
Thank you one moment for our next question.
Next question comes from Xena Mod at Bofa. Your line is open.
Hi, This is jeremiah on farms for today. Thank you for taking my question and congrats on the quarter. Just a quick question for Mike on your New go to market strategy can you highlight any specific targets for the team in the first six to 12 months and should we expect specific metrics on the new strategies benefit future earnings calls.
Sure. Thanks for the question so really the team I would say that the teams are now in place there is significant disruption in Q2 and in our case, 50% of our customer any customer facing sales forces either entirely new or new role.
<unk>.
Yeah.
So effectively.
Effectively happened our team is not in front of customers, but now that the team is in place and ramping up.
I can say that we have confidence that.
Yes.
With the changes that we've made that will continue to build on the foundation in the academic centers as well as drive the real untapped opportunity for us and lots of which is in the community setting and drive continued adoption there.
So more to come.
And then your question on metrics, we will of course show the relevant metrics just to show progress without growth for example, the community versus academic as we've done in the past.
Again, we believe the big opportunities that continue to grow in the community.
Our.
Our biggest competitor in the community is actually are based over our base chemo regimens and inertia in terms of behavior change is one of the things we have to overcome but will we believe with the new model, we can steadily make progress against that goal.
Great. Thanks.
Thank you one moment for our next question.
Our next question comes from the line of Marine Quebec from capital One Securities. Your line is open.
Hi, Good morning, Thanks for taking my question. So I just I'm curious about Lotus nine as you sort of.
Wind down that study.
Is there anything that can be drawn from that that you'd be able to share down the line and since there were those respiratory related events in the order failed population.
Do you think the label current label would be impacted by that.
Yes.
Sorry go ahead, ladies Robert I'll, just start and then I'm going to hand, it to you Mohammed Yes, we don't believe Theres any impact on our current label on any other trials.
And Mohammed will go through a little bit more specifics, but just when you look at the population.
Both in terms of age and underlying Comorbidities.
And the individual investigator assessments of the day.
That happened, which all except one exception, where there is a potential.
In relation to the treatment they were all deemed as likely unrelated. So we don't believe this has to do with the Roger and most likely.
And we don't plan on providing any markets because we made the choice to.
Eric to stop the study, but we don't believe there'll be any spillover any impact on the rest of this or not but Bob if you can go through more detail.
Yeah, Thanks, Larry and Thats, an excellent question.
Just want to make sure. It is clear that we did not see.
Inc.
Elias clear relationship between the faith of events and the treatment lumped up plus through the box.
For many reasons.
I wanted to remind you that the patient and Lucas nine by definition, we're frail or on fit many of which are <unk>.
Years of age or above.
With an active is significant and the Orion four more phases, one enrolled in the study.
Of course as a consequence it is highly unlikely they would have qualified for enrollment and with a five or seven and really very different population than where our label is.
Also important to highlight that two weeks ago in a plant.
DMC meeting for <unk>. There was no notable safety signals observed in the recommendation was to proceed with the study.
As planned with no changes as mentioned.
We then I believe there is any read through to Lucas five or look to seven or the label at this time.
Alright terrific things.
Very helpful and so obviously everybody has been mentioning the.
Launch of the Zipkin Liam on the so with regard to Lotus side.
Since here so many <unk> studies I'm, just wondering and they're also pursuing expansion strategies has that impacted enrollment for Lotus five and are you employing any strategies to sort of ensure.
New recruitment for that study.
Yes.
Matter of fact, we have not seen any impact enrollment of north of five 7% due to the mainly again for the fact that the population being studied as.
Is very distressed and investigators understand very well the difference between the population of Soviet Lucas' line and Lucas.
Lucas pipes. So we did not see an impact that enrollment in those studies and we continue to believe that we will complete enrollment of the spike in 2024.
Yes.
With regards to the Biospecifics based studies had been going on for a while right. So these I don't think much has changed if anything to be honest, we've actually seen a.
Since Muhammad joined and he implemented a number of changes so to give them credit around the clinical operation side, we've seen an acceleration overall recruitment was five.
So we're well on track to complete the study next year as we've said.
Great Okay, one more.
Mohammed.
In the press release, you mentioned that you're going with with the axle.
Product candidates <unk> hundred one.
Youre moving forward in non small cell lung cancer and sarcoma I believe when you bought Tacoma before can you talk about the rationale for for the.
Selecting these too.
Okay.
Thanks again for the question of CD based on preclinical.
Models and testing of the target expression on those models showing a higher the highest expression.
Arkoma and non small cell lung cancer with others.
Mark.
Those have the highest to that.
Based our selection on also if you know.
No about.
The bio after that work. They also started in short efficacy on both tumor types. So it's kind of validated the XL as a target and we believe those are the two.
First to study and if that looks positive we will be exploring definitely other tumor types.
Great. Thank you that's all for me.
Thank you one moment for our next question.
Okay.
Okay.
Our next question comes from the line of Boris Speaker at TD Cowen Your line is open.
Thanks. This is Nick on for Boris just two for me.
First one you mentioned you anticipate stable gross to net throughout the rest of 2023. So I was just wondering is that your plan for that to continue throughout 2024, as well or is that going to increase decrease.
And then on the clinical side for Lotus seven.
Do you plan to continue forward with multiple different combination. So I know that you are running motor seven with Dalonzo plus a few different types of combinations. If positive would you pick the best one or whats your approach to that.
On the gross to net side, we don't expect at this moment any change in gross to net from this year to next year. So it's basically from last year to this year, we had that increase as we explained before and then it should be.
Stable going forward.
Yes, but you want to take any questions.
With regard to fit with the seven which by specific to move forward for its really will be a data driven decision and seeing how the two.
Combinations look like or defer if any and in terms of of course, the any possible. Although we believe there is no overlapping toxicity, but we'll see how the safety profile looks like between the two agents and in addition, the efficacy.
The clinical pharmacology that durability of responses observed and based on that would be either making a selection of one or maybe in different tumor types. It could be <unk> follicular. So there could be different ways of exploring the two but we remain agnostic to any bi specific beginning the three.
Believe that.
The long term.
In Asia, the choice to be combined with almost any bi specific.
Currently being in development.
Thank you very much that's very helpful.
Thank you one moment for our next question.
Yeah.
Our next question comes from Jeffrey Hung of Morgan Stanley . Your line is open.
Hi, This is Michael Rehaut on for Jeff hung Thank you for taking our questions.
On the first one so the newfield model to what extent is covering topic accounts exclude the academic and community centers and how could they be targeted to raise awareness and drive the launch uptake.
Well.
Yes.
With the new model, how are we targeting the big academic or community accounts is that your question, Yes, that's correct.
Yes, Okay. So maybe you could describe the model the two different roles.
Sure. So we have two roles in the new model.
One that is focused on the top tier accounts and we staffed it with.
Folks who have extensive experience navigating complex institution. The other role is really to focus primarily on our community so clear.
Clear lines of accountability, but they're organized into local teams to really take advantage of a strong knowledge of the local dynamics referral patterns as dawn.
I want to make sure that answered your question.
Are they bigger managers are focused on large academic institutions, but also large community accounts or those types of oncology, Tennessee oncology, Florida cancer in Europe routing cancer all of these big institutions.
The account managers focused on the big account, whether it be academic or community and then that.
Specialized sales specialist focuses on the satellite centers of those big accounts and other community centers.
Knowing that the dynamics, particularly at <unk>.
Are very interrelated.
Thank you that's really helpful. Thanks, and then maybe as a follow up for 601 in 901 do you have any added color on the biomarker approach what sort of IFC data would you want to see to have confidence in its ability to guide the development and how soon could we see that implemented thanks so much.
At this stage, we are as I mentioned earlier, we are developing the immune ischemia CSA.
We haven't I'd say that we'll be testing first retrospectively in samples in the phase one study.
We see a need.
And a clear differentiation in terms of level of expression of the target that correlates with response.
Will it be possibly pre selected patient. However, it is a little bit early to tell right now that would be needed or not but thats. The overall thinking of what could be the possibility of using an mcf.
Thank you that's very helpful.
Thank you one moment for our next question.
Our next question comes from the line of Brian Chin at J P. Morgan Your line is open.
Hi, Tim and thanks for taking my question. This morning, maybe.
Maybe on sales just wondering what youre seeing from your sales force since the frontline approval for polo, plus our chip back in April .
Potential impact there are we through that was a factor and for the sales trajectory of Salon.
For the rest of the year.
Sure. So we have seen uptake of policy.
And what we do here whether its from primary market research or just in speaking with customers is that folks are eager to use it in a frontline setting for appropriate patients and what we also know is that the majority will not be complete with polar be once they've used in the frontline setting and we see this as potentially opening up in opex.
And my personal onto later lines of deadlines Atlanta.
Okay, and then on our European launch can you elaborate on how the country by country launch progress.
For the rest of the year. Thank you.
Yes, sure I mean as you know.
Reimbursement is a country by country.
So Germany is obviously the first country typically pricing is better there. So we are also launching in northern European markets of course in certain markets like Italy, or Spain, where you have regional reimbursement.
It takes longer and so they are well underway with a lot of the market access procedures in those countries across Europe . There also as you know have rights, even beyond Europe to most international territories outside of greater China and Japan. So they are also actively preparing for launches in those territories as well. So we see really strong progress from our partners.
And we think that they're executing the launch well right now.
Great. Thank you.
Okay.
I would now like to turn the conference back over to Amit.
For closing remarks.
So I just wanted to thank all of you for joining our call today I. Appreciate your interest in the company and thanks for your continued support we look forward to keeping you updated on our progress and I hope that you all have a very nice day. Thank you.
This concludes today's conference call. Thank you for participating you may now disconnect.
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