Q2 2023 MorphoSys AG Earnings Call
With that I'll now hand, the call over to Sean Please.
Thank you Julia.
Morning, and good afternoon, everyone. Thanks for joining us today.
We had an extremely productive and strong first half of 2023.
We delivered and surpassed expectations on our key priorities.
And we will continue to build on this great momentum as we enter an exciting second half of the year.
We completed enrollment of two of our pivotal trials ahead of schedule.
The manifest study of collaborative.
In first line myelofibrosis, and the frontline study of <unk>.
In first line <unk>.
Additionally, our partner insight completed enrollment for <unk> in mind.
Phase III study of <unk> in patients with relapsed refractory Follicular lymphoma marginal zone lymphoma.
Yes.
Furthermore, we presented updated results from our <unk> phase one two study <unk>.
<unk> casing the therapy is best in class potential in an array of cancer types.
We also took steps to further strengthen our financial position.
Today, we are well financed to drive forward optimizing mid to late stage clinical programs with more than 12 months of cash available. Following the top line readout of the manifest two study.
Also.
Lucy crop treat China's this month as our new Chief Financial Officer.
We are very pleased to officially have her.
On bolt.
<unk>, our investigational <unk> inhibitor.
Is a potential best and first in class foundational first line treatment for patients with myelofibrosis.
With this therapy, we have the opportunity to substantially improve the standard of care for this debilitating and difficult to treat disease.
Today, JAK inhibitors, such as <unk> or the standard of care to treat myelofibrosis.
These medications can reduce spleen size and relieves symptoms of myelofibrosis, but they do not address at Kohl's.
The more.
With his treatment strategy.
Only about 50% of patients achieved initial adequate disease control.
For many that's relief fades with time.
The results from our phase II manifest study subjects that pillar <unk> in combination with <unk> nib offers prolonged improvement in both spleen size and <unk>.
Symptom severity at and beyond 24 weeks.
Further to this in.
In the manifest study.
Kansas in Biomarkers correlated with improvements in clinical measures of treatment success.
Suggesting a potential disease modifying effect of pillar Brazil.
We believe these data underscore the strength of this combination therapy and its potential to be the future standard of care in myelofibrosis.
Based on precedent in first line myelofibrosis.
We believe that the results from phase III studies are strong indicators of what we can expect to see in phase III trials.
As such.
Based on our strong phase two results, we are very optimistic about the performance of the pillar <unk> and <unk> combination in our pivotal trials.
With top line data from the manifest two trial now expected by year's end.
We are hearing increased excitement from physician and patient communities around pillar precip.
Reflecting the dire need for more effective and well tolerated therapies to treat myelofibrosis.
We will remain laser focused on pillar, Brazil in first line myelofibrosis.
Delivering the phase III manifest to study results.
And simultaneously preparing our regulatory filings in the U S and Europe this year.
That said.
We also see great possibilities for pillar abrasive beyond myelofibrosis.
And we will continue to explore its therapeutic potential in other myeloid diseases, including lower risk Myelodysplastic syndrome also known as Mds.
And Exxon shell Trabocchi Timea also known as <unk>.
Tim will share more on this shortly.
Moving to module, we now.
Module <unk>.
As our CD 19 targeting immunotherapy.
It continues to be prescribed to certain adult patients with relapsed or refractory deal this year.
In the second quarter.
<unk> net sales were $23 6 million U S dollars.
This represents a 14% quarter over quarter growth and is on track with our 2023 guidance.
Beyond the currently approved indication we.
We see the largest potential upside for module b in the first line <unk>.
Which we are investigating in our phase III frontline study.
The trial <unk>, nearly 900 patients with data projected to be available in the second half of 2025.
Also module with use in relapsed refractory follicular lymphoma, and marginal zone lymphoma is being explored in the phase III in mind study.
These data will be available in 2024.
Okay.
We have a strong U S commercial infrastructure in place for <unk>.
We have encountered a large overlap in treating physicians for <unk> in myelofibrosis.
Especially in the community setting, where we have established relationships.
This would enable us to launch collaborate smoothly.
We've made exceptional progress with our pipeline.
As a result, we have a rich set of catalysts from our pivotal studies over the next two years.
Additionally, our key partner programs are progressing very well.
These programs developed via our legacy antibody technology platform.
Include yellow mud.
<unk> <unk>.
And <unk>.
While not a core focus of our business strategy. These programs offer potential upside and provide us with options for non dilutive financing.
I will now turn the call over to Tim to provide the development update Tim over to you. Please.
Thank you Sean.
Phase III manifest through study is our number one priority.
In this trial patients naive to JAK inhibitor therapies were randomized one to one to collaborative in combination with rux lipnick or placebo.
Placebo plus rux lipman.
Call that after we acquired constellation we optimized the manifest study by increasing our target enrollment from 310 to 400 patients in the end, we randomized 431 patients.
The primary endpoint of the study is the proportion of patients who achieve a 35 point or greater reduction in spleen volume at week 24, known SVR 35.
The key secondary endpoint of the study.
A portion of patients achieving a 50% or greater improvement in total symptom score known as TSS 50.
In addition to these two endpoints. We're also measuring the percent change in total symptom score at week 24 progression free survival overall survival duration of splenic and total symptom score response and improvement in bone marrow fibrosis among others.
We have confidence that the comprehensive manifest two data package will provide meaningful insights into the potential benefits of collaborative Amdocs development as a first line combination therapy for patients with myelofibrosis.
Our phase three manifest two study is supported by our phase III manifest trial.
These studies are very similar in terms of inclusion and exclusion criteria end points and treatment regimen.
Based on this and the overall body of data we have presented thus far.
We remain very confident in the collaborative <unk> combination and the outcome of the phase III manifest II trial.
We saw strong efficacy and safety results in the phase III manifest trial data that were presented most recently at the 2023 <unk> annual meeting in June .
At week 24.
68% of JAK inhibitor naive patients treated with a collaborative and racks lipnick combination achieved at least a 35% reduction in spleen volume from baseline.
Furthermore.
56% of patients had at least a 50% reduction in their total symptom score from baseline.
Deep and durable responses were maintained at 60 weeks.
The most common treatment emergent adverse events were low grade.
This data suggests that collaborative and <unk> is a well tolerated.
Combination therapy.
We compared manifest arm suite with <unk> historical JAK inhibitors studied in randomized double blind phase III trials, using a method called matching adjustments indirect comparison or Mike analysis.
Mike has been robust methods that ensure sphere and reliable comparison between trials.
It does this by making adjustments for differences in select baseline characteristics across the studies.
Our analysis shows that collaborative in combination with approximate offered at least one four times better symptom control compared to <unk> monotherapy in JAK inhibitor nave patients.
These findings were recently published and black advances.
Also at the 2020 <unk> annual meeting, we presented new data showing that hemoglobin levels were not only stabilized.
But importantly improved overtime in JAK inhibitor nave patients.
Treated with a collaborative and <unk> combination.
This has not been observed with <unk> monotherapy.
Treatment with this therapy has been shown to cause a drop in hemoglobin levels.
While our focus in 2023 remains on collaborative in first line myelofibrosis.
See opportunities for collaborative beyond this disease.
At this year's <unk> and <unk> annual meetings, we presented results from arm four of them.
Phase III manifest study.
This arm of the study is investigating <unk> as a monotherapy in patients with high risk <unk>.
Or refractory or intolerant to hydroxyurea, the chemotherapeutic agent most commonly used to treat the disease.
The primary endpoint of this arm of the study is confirmed complete hematologic response.
The secondary endpoints includes confirmed partial dermatological response and symptom improvement.
To date, our findings suggest that collaborative monotherapy provides the potential clinical benefit for this patient population.
60% of patients treated with <unk> monotherapy had a confirmed complete or partial hematologic response at anytime.
The data cutoff 14 of 20 patients were still undergoing treatment.
Importantly, and early normalization of platelet counts was achieved in many patients with white blood cell counts and hemoglobin stable throughout treatment.
This suggests that collaborative monotherapy cabinet based accounts without causing anemia or thrombocytopenia.
Further the results show that half of the treated patients had a 50% reduction in total symptom score from baseline at any time.
This proof of concept results support pillar <unk>.
Spansion into other myeloid diseases as such we will continue our ongoing evaluation of collateral.
And the manifest study.
We also plan to initiate a phase two study in lower risk Mds in 2024.
We will then determine our phase three development strategy. Following these assessments.
Moving on to 'twenty metal steps, our investigational next generation dual inhibitor of <unk> and <unk>.
<unk> metal stats was designed.
<unk> on first generation <unk> inhibitors through increased potency longer residence time on targets and a longer half life offering the potential for enhanced anti tumor activity.
It is currently being evaluated in a phase one two trial for advanced solid tumors or lymphoma.
Updated results from the phase II portion of the study were presented at <unk> 2023.
The data suggest responses or disease stabilization across all solid tumor cohorts.
<unk> with heavily pretreated patients.
Notably.
Fleet and partial responses were also observed in the lymphoma cohort.
Physicians have expressed great excitements about the deep responses seen in these heavily pretreated patients the majority of whom currently have limited or no treatment options.
These preliminary results are very promising and showcase the therapy is best in class potential.
Array of cancer types.
As we continue to generate data from the dose finding portion of our phase. One two study we will continue to evaluate our future development plans for 12, new metal steps.
With that I will now turn the call over to Lucy to review our financials.
Thank you, Tim and good morning, and good afternoon to everyone.
I am delighted to finally be with you today, having completed my prior role as CFO of <unk>.
This is an incredibly exciting time to be joining multistate and my focus will be to support the business and driving value for shareholders by enabling the successful progression of our oncology portfolio.
We're pleased to share our financial results for the second quarter and first half 2023.
<unk> sales were $23 $6 million in the second quarter of 2023, reflecting a sequential growth of 14% in a year.
EBITDA growth at 2%.
Also recorded $2 2 million euros or $2 $4 million in royalty revenue from <unk> sales outside of the U S from our partner insight in the second quarter of this year.
The sequential increase is mainly driven by a one time effect coming from previously deferred revenues related to insights early access program in France.
Total revenues in the second quarter of 2023 with $53 2 million compared.
Compared to $59 4 million in the same period a year ago.
The year over year decrease resulted primarily from lower expenses related to final sales to opana insight.
Recall that move doses provides insight with <unk> supply for ex U S sales.
This supply is recorded as revenue specifically reflected in the licenses milestones and other category under revenue and an equal amount is recorded in cost of sales, yielding a zero gross margin.
Total cost of sales was $7 7 million euros in the second quarter of 2023 compared to $17 2 million a year ago.
Cost of sales specific Tim on JV U S product sales was $4 1 million in the second quarter of 2023 compared to $4 3 million euros on the second quarter of 2022.
Turning to operating expenses.
R&D expenses in the second quarter of 2023 decreased slightly to 57 million euros.
Compared to $60 9 million euros for the second quarter of 2022.
Okay.
Selling expenses decreased to 22.
2000, 19 million in the second quarter of 2023 compared to 24 million euros for the same period in 2022.
The year over year decline was driven by streamlining and focusing our selling efforts.
Okay.
G&A expenses in second quarter of 2023 was 17 million euros compared to $2012 4 million euros in the second quarter of 2022.
The increase mainly results from increased expenses related to stock based compensation.
For the second quarter of 2023, we reported a consolidated net loss of 74 million euros.
To a net loss of 235 million euros in the second quarter of 2022.
As a reminder, the results for the second quarter of 2022 was mainly driven by findings finance expenses, resulting from FX effects for the insight and royalty pharma liabilities.
Turning to our balance sheet.
We ended the second quarter of 2023 with cash and investments of $672 8 million euros compared to $907 2 million euros at the end of 2022.
Recall that in the first half of this year, we spent approximately $40 million to repurchase parts of our convertible bonds to reduce our debt and to take advantage of the market dynamics and the bond is trading with a significant discount.
Our solid cash position enables us to not only reach the pivotal data milestone for the phase III study of <unk>.
Also provided cash runway at least 12 months beyond the pivotal data readout.
Turning to our guidance for 2023.
We are reiterating our guidance that was provided at the beginning of January this year.
Aspects of our guidance remains the same.
With that I'll now turn the call back to Sean pool.
Before we open up the line for questions I'd like to conclude with a few words.
The first half of 2023 has been marked by exceptional progress at <unk>.
We have all heard delivered on our key priorities and are excited to build on this great momentum in the second half of the year.
Elaborate seed represents a large and unique opportunity to address the critical needs of myelofibrosis patients.
We are very optimistic about the potential for <unk> to improve the standard of care as a foundational to first line treatment.
The body of data, we have presented thus far along with the size of our phase III <unk> phase II study give us high confidence in pillar abrasives clinical success.
We very much look forward to sharing the results of the manifest study later this year.
With that I would like to open the call for questions.
Operator, please open the line.
Ladies and gentlemen at this time, we will begin the question and answer session anyone who wishes to ask a question you May press star followed by one on the Touchtone telephone if you wish to remove yourself from the question queue. You May press star followed by <unk>.
In the interest of time, please limit yourself to two questions only.
Using speaker equipment to date, please lift the handset before making your selections anyone who has a question.
Followed by one at this time.
One moment for the first question please.
The first question is from <unk> <unk> from UBS. Please go ahead.
Thank you. Thank you for taking my questions two please.
The first one to see if I may so just wondering since he joined my focus just wondering what are your first impression of the new CEO . What is your strategy. What's your priority here anything you would like to share.
Sure that would be amazing and the second second question is and collaborative.
Just wondering now we have seen the nameplate of class topline data just wondering if there's I mean.
A lot of people have asked that what would happen. If collaborative also reporting mixed data in terms of if they hit the primary endpoint of myths TSS 15, so but now no visual cognex reported like that just wondering how does it change any of your fault on the it and does it make you more.
Our last relaxed holiday. Thank you.
Hi, Thanks. Thanks for your question I mean look I E.
And then credit date cited about joining multi assess it.
A pivotal point in time with the data <unk> and towards the end of this year. So.
I just wanted to sort of stress my excitement around the app.
The positioning is more thorough system and what we've got ahead of us and.
In terms of priorities and I'll, just reiterate what I had in my prepared statements and my focus is on growing shareholder value is supporting the business to deliver what we believe is an incredibly exciting future product and the myelofibrosis and other.
Obviously as you might expect and continue to diligently manage our.
Expenses in our Alco space.
Thanks, John for the question.
The competition even.
That everyone has seen a couple of weeks ago.
Look we think it's our this outcome is actually extremely positive from our forces.
And for US <unk> is not a surprise as they basically replicate that their phase II trial.
We have very high confidence in a positive manifest trial outcome for the following reasons.
Number one our study is very well powered.
We have upsized the trial after the takeover of constellation to 400 patients and we have over enrolled two father in 51 patients, which is almost double from the adverse numbers. The <unk>. One study is 252 patients. So we're very well powered and much more for them.
They are.
In our phase II trial of <unk>, we've shown a strong efficacy data with very strong on both endpoints. If we are 45 or 68% and TSS 50 of 56%.
Our safety results were actually very good. So this puts us apart from the competitor and we really think we have the best assets out there in myelofibrosis.
So as we saw recently phase two.
First line.
<unk> trials.
Our strong policy for phase III trials, so based on that and our strong phase two results. We think we'll have a very strong outcome with our phase III trial.
And we're very confident in that.
So basically we strongly believe in our assets and we think we have the best out there.
Thank you very much.
Thanks.
The next question is from Derek <unk> from Wells Fargo. Please go ahead.
Yeah.
Hey, good morning, and thanks for taking the questions just two from US So maybe just piggybacking on that.
First set of questions can you just discuss any specific differences in the enrollment criteria between the abbvie trial and manifest too.
And then the second question is so yes, gsk's locked them approvals coming up so I guess, we were wondering how you view that approval potential approval in the context of the fda's flexibility around efficacy endpoints in myelofibrosis because.
That drug was technically not inferior to <unk>, but it was numerically inferior so would love to get your comments there. Thanks.
Eric This is Kevin.
<unk> innovative products.
Our study.
Generally of the patient population is very comparable first time patients with myelofibrosis naive to JAK inhibitors, namely Iraq slip neck.
At Chubb, Paul mentioned and I would just emphasize that again and I've said this in my prepared remarks already.
Our phase II study showed very strong results on spleen volume response, and <unk> 50.
After year shows very clearly that phase III results are very well replicated in phase three.
If that holds true for us.
We are in a very good shape.
We continue to be Super confident.
And now on GSK, maybe I could add that.
Basically.
It's not the same regimen.
We're obviously exploring a combination regimen in first line, it's not the case for them. So.
<unk> is very difficult to draw down that looking at the same market share, which took my comments here and we'll see what.
In the next couple of months we are at.
Got it thanks, so much.
<unk>.
The next question is from Jason Butler from JMP. Please go ahead.
Hi, Thanks for taking my question.
First of all can you just.
Reiterate for us.
Confidence their 24 week data will be sufficient to support approval in Europe .
Expecting to the longer duration of follow up to support approval for power in Myelofibrosis, and then can you just walk us through the bulk.
The landscape in a central point of a cytopenia.
Sorry, forgive me I'm just.
How do you think the pelican fit into the treatment landscape. Thank you.
Okay.
Thanks, Jason This is Tim.
So no.
No very well from interactions with agencies on both side of the pond, namely FDA and EMA West B.
Approvable endpoints are and that's to your point is the 24 week landmark for F 35, and PFS 50.
On the question regarding the ETE landscape.
First things first.
Obviously, we will bring home manifest through first.
<unk> shared the very exciting and very strong proof of concept data in essential thrombocytopenia for these patients is of course very very important traveling normalization of their platelet count it's important for them to her.
Have kids and hematologic parameters.
Both are true.
Key science, our data is showing.
These patients also experience, commonly symptoms, which are measured in their total symptom score improvement here in our armed for data from manifest in Shoals.
Very encouraging data, so I think thats, a very strong and <unk>.
Comfortable basis for us.
Develop further steps.
Alright, thank you.
Next question is from James Quigley from Morgan Stanley . Please go ahead.
Yeah.
Hello, Thanks for taking my questions.
Sure.
Yeah.
So just to your point about me approval endpoint.
35 of them.
That's 50.
Just in thinking about in the context of the secondary endpoints.
Mentioned PFS and I'd ask that you are looking at.
To what extent is that flexibility around 50.
The other end points are here sorry for example.
If it does if that does happen in manifesto you hit on F 35.
You guys have 50, but you have a PFS benefit and the risk benefit to what extent is there flexibility around that in terms of discussions with the FDA.
And then secondly, with regard to the timing of the data.
As we get closer.
To what extent.
Presentation be be possible from manifest to.
The late breaker deadline.
October .
Uh huh.
Is there a possibility for a placeholder for manifest.
Actual results.
Zero Medici sooner okay. Thank you.
Hey, James Tim again.
So yes in terms of approval endpoints and again, we're very clear on what we need to show as we have 35 TSS 50 at week 24, as you pointed out additional endpoints are of course included in the study of secondaries to provide more colouring apps to provide a view on what ultimately matters to patients.
<unk> that's of course.
And of course safety, let's not forget about Tolerability for this somewhat chronic treatments super important for patients to live longer.
Good quality of life.
The parameters we're looking at.
Agencies typically evaluate the clinical package based on what they call. The totality of the evidence. So all these parameters will be taken into consideration by the agency.
Again, we feel super comfortable.
Confidence in that phase III design based.
Increasing sample size strong phase II data et cetera on the timing.
<unk> accelerated our top line read out as you know by at least six months.
And I think we'll leave it at that and we'll be I'm very excited to share that topline data.
The scientific community and of course, the Investor community and by the end of the year and James I would just add that when we acquired constellation we were more than one year behind.
The other.
Company exploring first line combination therapy and now we are probably ahead.
So I think already that tells a lot.
Excellent. Thank you very much.
Thanks James.
The next question is from MS. Ms Rockies from Deutsche Bank. Please go ahead.
<unk>.
Hi, Thank you for taking my question Moms, Mr. <unk> from Deutsche Bank. So first question for example, and Tim If you could give some color on your partner programs and more detail on the catalysts involved there as well as your confidence in dose and.
Some color on the expected royalty size.
And perhaps a sub question on that is what are your thoughts on any impact on the acquisition of your partner we're satisfied leaf.
To talk about the program.
Yeah, that's it thank you.
Thank you <unk>.
While we continue to be very excited and impressed by the performance of our partners.
In in the past, we've mainly singled out.
<unk>.
From now with Novartis.
Novartis has said that he is being explored.
In a couple of phase III trials.
Two immune diseases, and and they mentioned that it's going to be one of the top.
Blockbusters in the future.
Phase III plus.
Size of the opportunity is very promising and remember what we had with.
With Johnson and trimmed fire. So this is great, but the news here that we didn't really have time to tell you in the prepared remarks is on the <unk>, which is an obesity treats.
Treatments that we have in partnership with Chinese bio.
And Lilly as you know.
It is going to acquire for <unk> and they have a phase II b ongoing study everybody knows the excitement around the obesity market right now when there isn't really a breakthrough coming up sale and lease obviously, a huge name in this space, which we're very excited with that as well. So long story short we have a couple of key opportunities.
This year, we charter legacy.
Pipeline, we don't really.
Showcase it because it's not what we are focusing on operationally, but.
In the equation in the financing question, it's very important because that can mean royalties and our monetization.
We've shown very handsomely with royalty pharma four.
Fire and other assets. So this is great. It doesn't take any time it is pure upside and I wouldn't discount that in your models.
Okay.
Okay.
Okay.
Ladies and gentlemen, if you would like to ask a question. Please press the star followed by one on your telephone.
Next question is from Ranjan Sharma from Goldman Sachs. Please go ahead.
Hi, Thanks for taking my question just to follow up a little bit more on <unk>, specifically on the test that safety.
Could you just maybe talk to the potential differences between manifest two and transform which isn't the <unk> trial, which gives you confidence that you will hit on TSS 50 outside of just.
The powering and then secondly are there any kind of particular symptoms, which make up the components of the TSS 50, which you're most confident on given palace mechanism relative to other agents that we've seen in the in the field and then kind of related in arm three of manifest what proportion of patients achieved both.
SPL 35 on that.
TSS 50 endpoint.
Thanks, Paul I'll start by the first part.
And Tim will.
He will comment on the next one.
I'll come back to my first.
Comment.
The first question in the call.
I mean, the fact that we have both the power which is way above.
<unk> done the power from from Abbvie, and the fact that our phase II trial showed great presence on both endpoints is very is very strong and make us very confident in the outcome. That's that's really the really the main thing that you have to keep in mind here I mean, the phase II is a very good proxy for the phase III towards demonstrated a couple of.
Weeks ago.
Remember that Abbvie has a 42% <unk> score in the phase two trial with 56%. So we're not surprised again, so and we are extremely confident in the outcome of the phase III trial on the details on the TSS 50.
Yeah <unk> this is Tim.
Obviously, we cannot comment too much on the Abbvie trial design.
But I think we can assume is that everybody in this day and age is using the same.
<unk> to assess our TSS, that's the myelofibrosis symptom assessment form version 4.0.
It is a validated tool it's a tool that the health authorities.
<unk> strongly suggest a sponsor to use so from that perspective.
Toby level, playing field and again, our manifest arm three data gives us a very good benchmark what to expect from the phase III.
That obviously is very exciting to us I think we mentioned in the prepared remarks, but just to reiterate having tried to sample size.
That other molecule.
If the level of confidence that makes us feel very good about this.
The next question is from Ingrid <unk> from Bryan Garnier <unk> co. Please go ahead.
Hey, good afternoon. Thank you for taking my question I have two if I may.
I have a quick follow up regarding secondary endpoint for collaborative phase III trial more specifically.
As in the West.
Noting that we noticed two outcomes can take a little bit more time for me eligible patients. What do you have in mind in terms of how long follow up would you need to see to be able to comment some team members to earn points.
And my second question is actually for your plans in Mds, which can guess hasn't actually identified any sub population of Mds issue preferred target.
Should we expect higher next year.
Sure.
Starting with the last question first.
Mds trial design.
Currently looking as a proof of concept study.
It would be our fourth proof of concepts.
Collab receptacle further strengthening the foundation of the program.
In terms of subpopulations, where looking at low risk patients with Mds and we believe we have.
Good chance of showing a benefit with <unk> in monotherapy.
On the <unk>.
Manifest two questions regarding two additional endpoints PFS and OS as you rightfully mentioned it.
It takes some time for that data to mature.
The study will.
We'll continue collecting this follow up from patients duration of treatment is very good as we're seeing in manifest arm too.
The symptom control and touch screen control, we've shown up to 60 weeks, giving us a lot of confidence that there will be a change and an improvement in these two very important endpoints.
But it's suffice to say that we don't need that for the regulatory approvals.
Without our float is at 24 weeks and on the two end points. We mentioned is we are 35 anticipates 50.
So with sheep star-shaped data as we've always done with all of our studies with long term data, but again in MFS.
There is no I mean, it always takes a lot of time to come.
Thank you.
We have a follow up question from Manav Master Rockies from Deutsche Bank. Please go ahead.
Hi, Thanks, again, so just wanted to check your thoughts on.
Confidence on Columbia ship commercial appetite, assuming you have your best case scenario data.
Thank you.
Yes so.
The strength of the data.
I'm out here and from what we have seen under phase two and what we believe will be on the phase III. We think will have the data to establish a new standard of care here, So that being said we already have.
Our commercial and medical Affairs, Hematology oncology organization as you know with our.
Currently commercialized asset <unk> and there is a lot of overlap between the customers so well.
We have down gauge mens already we have the relationships.
We will not be a first time launcher fourth pillar receipts with the huge difference from the days of the launch of modules.
Any further questions. Please press star and one.
The next question is a follow up from Ranjan Sharma from Goldman Goldman Sachs. Please go ahead.
Hi, Thanks for taking my follow ups, So I've actually got one on <unk> and I was just wondering.
Just kind of.
If theres been a change in the competitive dynamics that you're seeing following kind of a negative negative clinical update for the long term and then I realize it's a slightly different label, but just.
Any thoughts on kind of initial competition from the CD 20 by specifics.
<unk> launched and then just to follow up on a manifest two again sorry.
And on three of my question I was just wondering do you have the.
The number of patients achieved both SPL 35 on TSS 50.
Both endpoints rather than just hitting on one thank you.
Regina, we'll take the <unk> question and Tim will comment on the other one on pillar.
<unk>, we are we continue to educate on our strong long term data and most recently the five year data in our <unk> very good traction with it but as you mentioned there is increasing competition, we think we're doing pretty well in the context of this.
Is the market.
Where we really see.
The inflection point.
With new indications.
Bubbly, mainly with the first line data this year that we comment commented in our prepared remarks.
Completion of recruitment for first line phase III trial frontline.
We enrolled 900 patients which in this market is remarkable.
There's a lot of interest for <unk> for first line data. This year as you know down on many therapies out there.
And what we had with the <unk> date and approval.
A couple of months ago is very encouraging for us because we have made the right choices in terms of clinical trial design for this frontline study. So we just have to be patient because it is a PFS driven study and.
I mean, we think we will have a strong data and it will be a very good.
Propeller thoughtful on jewelry in terms of other assets news on debt that you mentioned in first line I think yes.
Yes, well, it's good for us.
Kim.
Yes.
Question percentage of patients who achieve SVR at 35, <unk> 50 in arm three of manifest that data has not been published yet so.
At a future conference.
Thank you.
Okay.
There are no further questions at this time I hand back to <unk> for closing comments.
Ladies and gentlemen. This concludes today's conference call. If any of you would like to follow up with Investor Relations team is available for the remainder of the day.
Once again, thank you for joining our call and have a good day and goodbye.
Ladies and gentlemen, the conference has now concluded and you may disconnect. Your telephone. Thank you for joining and have a pleasant day goodbye.