Q2 2023 ImmunoGen Inc Earnings Call
Okay.
Good morning, and welcome to imaging.
Second quarter 'twenty to 'twenty, three financial and operating results Conference call. Today's conference is being recorded at this time I'd like to turn the call over to Annabel Chan head of Investor Relations. Please go ahead.
Good morning, and thank you for joining today's call.
Earlier today, we issued a press release that includes a summary of our recent operating progress.
Second quarter financial results.
This press release, a recording of this call and an updated corporate deck can be found under the investors and media section of our website at <unk> Dot com.
With me today are mark entity, our president and CEO , Isabel, California, our Chief commercial officer.
<unk>, our chief Medical Officer.
<unk> our interim CFO .
Michael back to yourselves, our EVP of research development and Medical Affairs will also join us for Q&A.
During today's call. We will review recent progress for the business, our financial results and highlight upcoming anticipated events.
We will be making forward looking statements based on our current expectations and beliefs.
These statements are subject to risks and uncertainties and our actual results may differ materially.
Please consult the risks outlined in our press release issued this morning, and the risk factors section of our most recent annual report on Form 10-K, and quarterly report on Form 10-Q, and our other SEC filings, which are available at SEC Gov and immunogen Dot com.
With that I'll turn the call over to Mark.
Thanks, Annabel good morning, everyone and thank you for joining us today.
You will have seen this morning's press release announcing that Ana will be stepping down from her position as immunogen, Chief Medical officer to take a well deserved professional hiatus prior to pursuing new opportunities I would like to take a moment to personally acknowledge and thank her for the central role. She has played in the transformation of this company.
We've encountered no small amount of adversity as we navigated the last four years at immunogenic through it all Anna Rose to the challenge with intellect grit and good humor. A particular note. She led the design and execution of the pivotal development program for early here that culminated in an FDA accelerated approval late.
Last year and the unprecedented survival data shared at <unk> in June that have transformed the treatment landscape for patients with fr Alpha positive ovarian cancer in parallel under her leadership. We've also advanced our broader clinical pipeline, including our second pivotal program and built a highly talented development ores.
Innovation, Anna I value you as a colleague and wish you the very best in your future endeavors on behalf of Immunogen, our collaborators and most importantly patients in need of more good days. Thank you.
So moving to our second quarter results since our last call. We've made great progress on multiple fronts and achieved a significant milestone for patients and our organization with our confirmatory phase III Mirasol trial meeting not only the primary endpoint of progression free survival, but also objective response rate.
And most importantly overall survival. This is an unprecedented result in platinum resistant ovarian cancer, making ala here. The first novel therapy to demonstrate an overall survival benefit versus chemotherapy in a phase III trial with.
With these results now in hand, we anticipate submitting an MAA in Europe and the S. BLA in the U S. Both in the fourth quarter of this year.
Turning to our commercial performance, we delivered a strong quarter with Ela here generating over $75 million in that sales more than doubling our Q1 result, with increasing breadth and depth of adoption Isabelle will provide more detail on our progress with the launch in a moment.
At the initial point given that this is just our second full quarter on the market coupled with recent developments with both Ela here and the broader ovarian cancer landscape, we've elected not to provide full year guidance for <unk> revenue today.
The basis for this decision is this we simply have not yet accumulated sufficient data inexperienced confidently project that trajectory for Ela here over the back half of this year.
The key variables underlying this decision include evolution of treatment rates given the compelling efficacy of Ela here, we believe treatment rates may be increasing over historical benchmarks, particularly for later line patients.
Shifting from prevalent incident populations, which may potentially affect the growth rate of new patient starts.
<unk> therapy, the claims data, which lagged the market by 90 days or more are not mature enough for us to provide a reliable forecast of how long patients are remaining on therapy at this time.
Mix of testing at initial diagnosis versus testing to initiate treatment and finally monotherapy versus combination use we are tapping multiple data sources to assess the percentage of combination use which have yielded somewhat disparate outputs up to this point our clinical data suggests the combination.
<unk> tends to generate higher response rates and longer durations of response, so an accurate assessment of this use is important.
You will appreciate that each of these variables can have significant impact on adoption and adherence to better assess the evolving market here. We have commissioned the demand study with the goal of increasing our confidence in assessing trends in the growth trajectory for the product.
In addition, our existing vendors are updating their databases and we are evaluating additional sources to gather more insights into the market. We look forward to updating you on our progress on these activities during subsequent calls.
In terms of ongoing development, we are advancing our efforts to move early here into broader patient populations and the position. It is the combination of choice in ovarian cancer. We look forward to our next milestone for the <unk> program with one of our data from our Piccolo trial expected before the end of the year.
Moving to our <unk> program, we've completed enrollment in the pivotal de Novo patient cohort of the cadenza trial and expect top line data in 2024. In addition, we progressed our 802 trial if feedback in combination with van Asia for newly diagnosed AML patients and look forward to reporting data from these frontline.
Cohorts at Ash later this year.
At the rest of the pipeline IMS, you see 93, 6% and IMG and $1 501 are progressing and we remain focused on reinvesting in our research capabilities and expanding our pipeline.
Together with a strong balance sheet bolstered by our follow on offering our progress over the first six months of the year has positioned us well to create meaningful value for our patients and our shareholders in the second half of 2023 and well beyond.
With that I'll turn the call over to Isabelle to cover our commercial progress Isabelle. Thank.
Thank you Mike we continue to successfully execute our growth before launch in pregnancies as we work to position <unk> as the standard of care portfolio.
Also positive ovarian cancer.
In the second quarter, we generated seven to $7 $4 million in that so we're very pleased with that.
Strong quarter performance and believe this is due to the combination of factors, including the solid execution of the commercial teams provide us engagement by our medical team increased breadth and depth of adoption driven by recognition of the benefit. This novel treatment brings to patients with advanced ovarian cancer and the <unk>.
<unk> made a full data increasing awareness and interest from both patients and physicians.
Uptake in the quarter continued to be broad and deep with a significant percentage of accounts with repeat orders complemented by consistent ordering from new accounts.
Academic institutions comprised our largest customer roughly 65% of orders during the quarter came from non academic institutions and community based oncology groups, but 70%.
First quarter.
We anticipate the needs of orders to continue to achieve with an increasing percentage coming from academic accounts as satellite centers a major institution.
Infusion.
Regarding testing in response to the continuous strong demand for the 40 <unk> diagnostic test additional loss activity being certified to round that.
As of the ended the quarter, we had 33 labs comprised of <unk> centralized labs and 18 in House lab.
Fully certified with 15 additional lab in the process of validation of note as testing because more decentralized will have decreased visibility into the number of tests performed.
Based on the information visible to us we estimate that roughly 11800 tests have been performed launch to date through the end of June with a significant percentage of this debt being for newly diagnosed patients.
In addition, the 40 receptor alpha positive rate remains between 35 and 40% in line with our expectations.
Moving onto Axis, we continue to be very pleased with how big your base, having to hearing governance policies online without legal.
We ended the quarter with roughly 95% of Medicare and commercial lives covered.
Lastly, our customer facing sales team remain highly active.
So Dan of June our commercial team has engaged roughly 90% of the priority targets on our <unk>.
Medical Affairs team continues to provide a full suite of support to ensure positive physician and patient experiences.
Reports from the field consistently really enthusiastic feedback from Tunisia.
And their experience with Ela here, which is a testament to our customer a healthcare professional facing organization.
In summary, we're very pleased with our performance and look forward to carrying this momentum into the second half of the year.
With that.
I would like to turn the call over to Anna to provide additional color on the meter of data on our ongoing development program.
Thanks Isabelle.
Before I get into my update thank you Mark for your kind words at the top of today's call. It has been a pleasure and privilege to serve this organization.
Take immense pride in having been part of this leadership team and having built a clinical development team comprised of top talent that executed effectively during a global pandemic, leading to the accelerated approval of <unk> with a broader than anticipated initial label and the first ever overall survival benefit for a novel therapy in <unk>.
Resistant ovarian cancer.
What we have done together is remarkable.
For the opportunities he has given me and for your leadership.
Now moving on to a review of the clinical programs. We were thrilled that shortly after we press released the top line data on May 3rd Dr. Kathleen more was able to present, the key efficacy and safety results from the confirmatory Mirasol trial in a late breaker oral presentation at <unk> in early June .
Since then we have continued to engage with stakeholders across the ovarian cancer community and the enthusiasm for these data in the broader <unk> program is high.
As a reminder, mirasol is the randomized confirmatory phase III trial of <unk> versus investigator's choice of chemotherapy weekly Paclitaxel, Pegylated, <unk> doxorubicin or <unk> in patients with platinum resistant ovarian cancer, whose tumors express high levels of folate receptor Alpha and who have received up to three.
Prior regimen.
The trial was a resounding success and we are pleased that our compelling efficacy data with an unprecedented overall survival advantage were complemented by a consistent safety profile aligned to our prior clinical trial experience.
Starting with safety. The AE profile continues to consist of predominantly low grade ocular and gastrointestinal events with no new safety signals identified notably compared with chemotherapy Merv was associated with lower rates of grade three or greater treatment emergent adverse events serious adverse.
And importantly, a lower rate of treatment emergent adverse events, leading to discontinuation of study drug.
The primary efficacy endpoint of progression free survival by investigator.
<unk> achieved a hazard ratio of <unk>, six five and a P value of less than 0001, representing a 35% reduction in the risk of progression or death for the <unk> treated population compared with chemotherapy.
The key secondary endpoint objective response rate was also highly statistically significant on the mirv arm or are was nearly triple compared to chemotherapy at 42, 3% with 12 complete responses compared with 15, 9% and no complete responses on the chemotherapy control arm.
As reported by investigators.
<unk> or our results by blinded independent Central review were concordant with investigator assessment.
Turning to the most meaningful clinical endpoint overall survival with 204 events reported <unk> demonstrated a statistically significant improvement in survival compared to chemotherapy with a hazard ratio of <unk> 67, and a P value of 0.0046 this correspond.
Two a 33% reduction in the risk of death with Ela here compared to chemotherapy.
The median overall survival with Ela here was $16 four six months compared with $12 75 months on the chemotherapy control arm as Mark noted earlier Ela here is the first drug to demonstrate an OS benefit in a phase III trial in platinum resistant ovarian cancer quite simply these data our practice changing.
Let me now turn to the broader <unk> Mab development program, which has the potential to meaningfully expand the <unk> label by moving into platinum sensitive disease and positioning <unk> as the combination agent of choice in ovarian cancer.
Specifically, we are progressing three studies. The first is piccolo, a single arm phase II trial, evaluating mirv monotherapy and folate receptor Alpha high platinum sensitive ovarian cancer enrollment was completed in January and we anticipate sharing or our data by the end of this year with duration of response.
<unk> data expected in 2024.
The second is glorioso, our phase III trial, evaluating <unk>, plus bevacizumab maintenance versus standard of care Bevacizumab maintenance in the second line platinum sensitive setting.
This study leavers are robust mirv, plus bev data in the treatment setting, which led to end CCN compendium listing for mirv Bev in platinum resistant ovarian cancer into the platinum sensitive maintenance setting where patients may stand to benefit from even longer durations of therapy.
And the third is trial for 'twenty, a single arm phase II trial, evaluating <unk> plus carboplatin, followed by MRF continuation in platinum sensitive ovarian cancer patients with low medium or high levels of folate receptor alpha expression.
Both combination trials glorioso and trial for 'twenty are enrolling in the U S and are getting going in Europe .
Moving to our second pivotal program, we presented data from an interim analysis of the phase II cadenza trial of <unk> in patients with frontline and relapsed refractory bpd CN at the EAA or <unk> conference in June .
<unk> demonstrated encouraging clinical activity and tolerability, especially in light of the toxicities of the available therapy.
In the frontline setting we observed a composite CR rate of over 70% and a median duration of response of over 12 months.
In the relapsed refractory setting which included patients previously treated with <unk>.
We observed a PCR rate of 20% and a median duration of response of over seven months.
Commensurate with the increasing awareness of the potential payback in this ultra rare indications. We are pleased to share that we have completed enrollment in the pivotal frontline de novo <unk> cohort of cadenza and anticipate top line data in 2024.
For our 802 trial of <unk> in combination with <unk> in frontline AML, we have enrolled 25 patients in both the <unk> 14 day clock and the 28 day minus triplet cohort. These data will help us optimize the duration of the Nida clocks for the triplet.
And guide pivotal development in frontline AML, we look forward to reporting data from these cohorts at Ash later this year.
As for our earlier stage assets on <unk> 936, our first in class Adam nine targeting ADC in co development with Macrogenics enrollment progressed in our non small cell lung cancer expansion cohort and we plan to provide an update after the protocol specified interim analysis is completed which we expect later this year.
Lastly, we are progressing our phase one trial of IMG and 151, our next generation anti folate receptor alpha targeting ADC to address a broader range of folate receptor alpha expressing tumors initial exploration is in ovarian and endometrial cancers and dose escalation is proceeding as anticipated.
In closing I want to thank all my immunogen colleagues for their ongoing commitment to delivering more good days for patients with cancer I will cherish my time with this business both professionally and personally.
As to what's next I look forward to spending time with my family continuing My board work and pursuing consulting in the coming months, while I watch immunogen, great future unfold.
With that I'll turn the call over to Renee to cover our financials Rene.
Thanks Anna.
For the second quarter of 2023, we generated $83 $2 million in revenue, including $77 4 million and net product sales of Ela here.
And the remainder from noncash royalty revenues.
Operating expenses were $86 4 million.
Just a $50 $1 million of R&D expenses, and $36 $4 million of SG&A expenses.
And may pursuant to an equity offering we further strengthened our balance sheet generating approximately $351 million in net proceeds.
We ended the second quarter with $572 million in cash on the balance sheet.
Our financial guidance for 2023 has been updated and we now expect operating expenses between $350 million and $365 million.
This increase reflects greater spending in support of Ela here, including preparations for a launch in Europe . In addition to expanding our research capabilities and pipeline.
Our revenue guidance, excluding <unk> sales remains unchanged at between 45 and $50 million.
We expect that our existing cash and cash equivalents together with anticipated future product and collaboration revenues will fund operations for more than two years.
With that we'll open the call for questions.
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 one again please.
Please standby, while we compile the Q&A roster.
The first question comes from John Newman with Canaccord. Your line is open.
Hi, guys. Thanks for taking my question. So first I just wanted to say congrats on all the great work of the region.
You'll certainly be missed and.
This is the best companies in biotech are the ones that can execute the clinical studies.
Near perfect and amusing certainly included in that bucket.
Just had one question, which is we know that Merck Rituximab and Mirasol was tested in patients with Fr Alpha high.
Confirmed by three plus.
Good question, Michael just curious if you can talk about whether you would expect mirv or I should say here now it will be used in patients with two plus expression levels and perhaps if we're seeing that at the moment. Thanks.
Yeah.
Thanks, John Thank you for your kind words, just to clarify the definition of Fr Alpha high expression by our companion diagnostic is at least 75% of tumor cells at least two plus positive by immunohistochemistry staining. So two plus three plus.
And that comprises between 35 and 40% of all ovarian cancer patients and the commercial testing has performed as we've seen in clinical trials.
We have previously explored <unk> in patients with lower levels of Fr Alpha expression as mono therapy, you can recall from forward one.
And we know from that study that patients with medium levels of fr Alpha expression, which is at least 50% of cells. So medium is between 50% and 75% of cells with at least two plus expression.
By Immunohistochemistry and that encompasses about another 20% of ovarian cancer patients. We do know that they do about as well with <unk> as with investigator choice chemotherapy based on a post hoc exploratory analysis.
And certainly based on that data as well as some preclinical data that we have showing synergy with various agents. We are exploring patients with lower levels of fr Alpha expression in our combination strategies. We also know that when we combined <unk> with bevacizumab across a broad range of fr Alpha.
<unk>, so low medium and high low as being at least.
25% to 50% of cells with at least two plus expression that we get very nice data that were published earlier this year in the <unk> and that led to compendium listing for mirv, plus bev for patients with low medium or high fr Alpha expression and that encompasses about 80% of ovarian cancer patients.
Looking to the future. We're also combining mirv with Carboplatin.
In patients with low medium and high fr Alpha expression in.
In our <unk> study so our initial approval in patients with high Fr Alpha expression for Mirv monotherapy is just the beginning.
Great. Thank you. Thank you just one quick additional question on combination with Susan I'm, just curious if youre seeing anything at the moment from your data.
Uh huh.
With regard to perhaps uptake there in combination with what is the best.
Yes. The answer is yes, so when we look at the claims data and I'm sure. We'll have lots of questions on that it's early days, but we absolutely do see.
Combination use.
As part of the claims that in the feedback that we get anecdotally certainly supports that.
Great. Thank you.
Please standby for the next question.
The next question comes from Michael Schmidt with Guggenheim. Your line is open.
Hey, guys. Thanks for taking my questions and congrats on another very strong quarter and let me just add my congratulations to all of us.
Therefore, the successor John you.
You will be missed obviously, but.
A question on that.
Good logging testing paradigm, so in our due diligence.
And we've heard that.
Many of the large academic institutions.
Our in house testing overusing, the centralized labs that yes.
And I was wondering if you could confirm that on how many of the big centers are not yet certified for in house testing in the U S.
Thank you.
As you know we had a very strong demand for testing so far and in the second quarter. We surpassed 11400 deaths and now we are at over 20000 tests, we can confirm that as of today.
When it comes to the labs, we have 33 lots that are operational of which 16 I'm kind of makes centers and those centers, we had less D. C. D. C have all the data that we have.
In process, we have another 15 labs that are in the process.
So it being certified so we.
We continue to see very strong testing as I just mentioned.
Okay. Thank you.
<unk>.
Regarding the Piccolo study how should we think about the regulatory bar for response rate in platinum sensitive setting as the bar similar to that.
<unk> applied to the psoriasis study for example, or is it higher or lower.
I think the bar is to be determined Michael because.
The landscape has evolved with the incorporation of PARP inhibitor maintenance.
Particularly now in the frontline setting and.
And we know from multiple studies that unfortunately.
Part maintenance therapy.
It seems to induce resistance to subsequent DNA damaging agents, particularly things like platinum.
As well as to a boutique and doctoral which also our DNA damaging agents.
But what that means is that patients who are technically platinum sensitive post apart inhibitor in other words, they've recurred greater than six months. After the last dose of their last platinum may not be as sensitive to platinum as they were previously so.
So that coupled with the fact that there were not.
There are no robust randomized phase III level, one evidence studies in later line platinum sensitive disease to begin with even in the pre PARP days.
We don't really know what the benchmark is that said more studies are coming out again showing that more platinum for these post part patients may not be in their best interest so.
The way, we're thinking about it is that the higher the response rate the longer the duration of response in piccolo the easier the conversation will be with regulators about what an appropriate bar would be for us to beat so.
So at this point, we're really excited about the Piccolo study were on track for or our data before the end of the year. We know these patients are doing well and so we will anticipate having DLR data next year.
Okay. Thank you and then last question just regarding the <unk>.
Two study of <unk> in AML could you just remind us of the two cohorts that you're running in frontline and what what are you looking for.
State of that would support initiation of phase II trials.
The primary look at safety or certain efficacy measures are important as well for you.
Or so just as background when Asia has become the new standard of care for unfit frontline AML patients, which is about all of the about half of AML patients. Although even the definition of unfit is being evolved so that more patients do get then Asia that said it is.
Tough regimen in and of itself at the labeled <unk>.
<unk> and schedules.
Many compounds have tried to combine with Vanessa and has failed because of just excess toxicity of the triplet ours is not one of those we are one of the few that has been able to combine successfully.
And so we started out I would say in an appropriately conservative manner to protect patient safety with what's called a 14 day.
<unk> regimen of it need a collapse in the relapsed refractory setting we proved safety of that regimen and moved it up into the frontline.
Setting, where we had 10 patients worth of data we presented at Ash last year with the 14 day plus regimen in conversation with FDA FDA made it clear their expectation is that we combine with the standard or labeled dose and schedule of that in Asia and the need of classes generally given per les.
<unk> up to 28 days.
Our ROE, but the problem is many patients can't tolerate.
That extended duration of the Nida class because of the profound mindless depression.
And so we.
<unk> basically completed accrual now in 25 patients using what we call a 14 day, plus and 25 patients in the 28 day minus regimens. So what happens is for each of these patients do get a bone marrow.
Around 14 days in the 14 day, plus or later in the 28 day minus regimen and if patients have residual blasts. They continue with the many of the clocks if the bone marrow shows no blasts then they stop.
They need a class because at that point they needed class would just be adding toxicity.
And so we're going to combine the data from those sets to understand the safety of the triplet understand the efficacy both in terms of CR rate as well as M. R D or measurable residual disease right.
And both safety and efficacy will guide how were thinking about our frontline pivotal triplet AML a registrational trial, so stay tuned for ash.
Super Thanks for all the detail on them.
Please standby for the next question.
Our next question comes from Peter Lawson with Barclays. Your line is open.
Great. Thanks, so much just wanted to offer my congratulations and also wanted to mention indoors.
Been a pleasure talking to you rather than.
The next step.
Just as.
As we think about the the duration of here. So wondering if you could kind of provide some color. It sounds like there is a range you're getting from your estimates Britney Spears and if you can give around that range for the duration of use.
The line of therapy.
Whether youre, mostly seen in combination with <unk>.
So.
It starts with the claims data right and so.
Trickles in so.
We gather those data. So for example, if you look at.
The last claims data I saw was earlier this month, we had four patients reported right and so it's a little hard to.
Think about it.
Extrapolating that over the back half of the year, when you sort of have to backup than 90 days and Cheyenne accumulate.
Totality of.
The experience and then project that forward and so duration of therapy falls exactly into that bucket, which is.
It's difficult to ascertain at this point when we look at the accounts versus the claims data to SaaS.
What's happening commercially.
With the brand at this point and so.
Our experience that we have related is with.
The <unk> data, where it's complete where we saw a mean number of cycles of seven.
In that population that population certainly was the most heavily pretreated.
<unk>.
What we've observed in our in our clinical experience and so I think that that's a baseline for duration of therapy, what we can say Peter generally is that.
Initial stages of the launch the claims data indicate that.
We were starting in later line patients.
Particularly with the.
Mirasol data, what we see is movement into earlier line patients, which we think will correspond with longer durations of therapy generally and.
In addition to that what we see are.
Combination use.
Results from that as we shared in the prepared remarks for today are disparate across the databases. So we're making a concerted effort to try and reconcile those databases and supplement that with demand study in order to get a better assessment of what's going on but it was.
Those factors as we think about this.
The commercial team here has put together essentially a matrix.
And on one one axis is the impact that it has on on revenue and on the other is our confidence level. So when we look at things that have high impact and high confidence. We included their fr Alpha positivity rate because we've we've run the experiment on over 13000.
Test and have a pretty high degree of confidence in terms of the positivity rate.
In terms of duration of therapy, we just simply haven't incomplete data set when we look over over the claims data and similarly, we just see an evolving picture in terms of lines of therapy. So.
Again, it's something that we are.
Working on aggressively in order to have a very clear view of the markets that we can articulate to the investment community.
Got you.
Conversations with physicians there is that point into most of the combination use or is it again kind of.
Broad range.
We see a significant percentage.
Physicians report to us in their practices that a significant percentage of users in combination.
Okay. Thank you switch a jump back into the queue.
Please standby for the next question.
Okay.
Next question comes from it Sir Darrow with BMO capital markets. Your line is open.
Great. Thank you and congrats on the quarter and also would like to.
Echo my colleagues sentiment on the contribution that you've had to <unk> story.
First question for me is.
I just wondered if you can maybe talk a little bit about.
Some of the major differences in ovarian cancer treatment or practice I guess in the U S versus some of the major countries in the EU and.
What impact maybe those differences could have on sort of the launch trajectory or maybe your overall strategy in Europe versus what we've seen early on here in the U S. And then I have a follow up thanks.
Sure. So I'll start with practice pattern differences and then turn it over to my colleagues to discuss how that influences our launch strategy in Europe .
The one real difference out there is.
How and when physicians use bevacizumab or Avastin and we've known that it was approved in 2014 2015. It had three approvals in the U S and Europe . It's approved in combination with chemotherapy in platinum resistant disease, it's approved in combination with chemotherapy in recur.
Current platinum sensitive disease, and then continued as maintenance and in the frontline setting in combination with chemotherapy and as continued as maintenance.
The problem with Bev is that it's never shown an overall survival advantage in any of these settings, except in a core prognosis high risk subset in the frontline setting. So these are patients who present with stage four disease or parenchyma metastasis. They have a society there are sub optimally debulked.
In that subset. The addition of Bevacizumab does improve overall survival, so particularly in Europe .
Oftentimes Bevacizumab is only.
Reimbursed or the patients only have access to bevacizumab in that frontline poor risk setting and in fact that kind of bore out in our survey a study where you know the majority of patients were enrolled in the U S. Excuse me in Europe and that study had a higher percentage of stage four patients than is typically seen in real.
Appstore recurrent.
Varian cancer study.
So because of that in Europe , a higher percentage of patients in the platinum resistant setting get single agent chemotherapy and that's important for how we're thinking about ela here when we get it approved.
Yes, the way to sort of place where the launches got the unmet need there do you see any higher and the number of patients that would be a logical just wondering here is also higher.
Our goal therefore is to as I mentioned is by Mark is to file by the end of this year and we are making significant progress towards the launch first we're working on our global values here on pricing and they are seeing in Europe tend to value overall survival data. So we feel very confident.
That will give us his tone initial position there.
Second we are really pleased that we have a very solid engagement with kols, there as you remember or 70% of our patients into clinical studies.
Raul is U S. So those various strong relationships, we're leveraging that we will be having two oral presentations at <unk> in Istanbul at the end of September and we also we have a person of asthma. So we'll continue to have these one on one engagement and we're also partnering with the community in preparation for the launch.
Finally, we are ramping up the team there was preparing for execution and we feel very confident that we have at such as launching us into the U S.
Maybe the only other thing to add there answer is that it's just a very highly concentrated market.
So when we do the market research across both.
Our five largest markets and expanding that into 16 markets. We see a relatively consistent pattern, which is a small number of centers treat a high percentage of the patients. So when we look at the five key markets for example.
60 odd centers treating 80% of the market. So this is something that we can address.
A modest incremental commercial investment and particularly given the data that we have.
As Bill mentioned the relationships that we have we expect a very robust launch there.
Great. Thank you and then the follow up was on <unk>.
<unk> hundred six sort of the market here is paying a lot of attention to sort of another ADC mechanism. The trop two in non small cell lung cancer and for sort of the interim analysis that you have maybe in the back half of this year, how youre thinking about what the go no go is it going to be on response rate duration of response is it.
Maybe PFS if you could maybe provide a little bit of color on how youre thinking about sort of the go forward.
Our strategy on that asset thank you.
Sure. So <unk> 93, six as our atom <unk> targeting ADC that Adam is expressed across a broad array of solid tumors and we've prioritized non small cell lung cancer based on what we saw early in development and so we have expanded the first stage of a Tuesday.
H design, if you will.
To understand the activity of <unk> 936 in non small cell lung cancer and I think the initial hurdle answer would be just overall response rate or objective response rate and the initial cohort of patients and.
At that point.
That data would guide further expansion into the second stage at which point, we would have a larger data set where we would look at <unk> and DLR to assess.
How we're thinking about further development.
Just in terms of single arm studies in PFS data typically it's hard to make.
Robust decisions based on PFS, so, it's typically or R&D or data that will guide further decision making.
Great. Thank you.
Please standby for the next question.
The next question comes from Boris <unk> with Cowen Your line is open.
Thank you and I'd like to add my congratulations to <unk>.
Specifically and the entire management team for the excellent progress.
So maybe my first question is on the testing centers, you've obviously mentioned that there has been an increasing testing centers being brought online, but how much do you estimate maybe the current revenue being potentially limited based on the existing testing infrastructure in the second quarter.
Not at all.
We're just testing is simply not a barrier to entry.
We do know that the.
The institutions at present have a preference for in house testing, but that didnt prevent them from sending.
First out.
So before Theyre centers were open we could see.
Ordering from accounts and testing from accounts that didnt have in house testing.
And as we've as we've mentioned.
Time progresses, a number of those institutions are taking it in house.
I'll also say Boris is we've actually had some interesting conversations about this phenomenon as it related to.
The PD one PDL, one testing and what we hear is that initially there was great enthusiasm among.
The academic institutions to take that testing in house, however, over time that enthusiasm wanes, some degree and they began sending their test back out to a centralized lab. So.
As we've discussed we see the migration in house.
Over time, whether that is a sustainable phenomenon I think is an open question at this point, but just to be very clear. We've done over 13000 tests launched to date. It has simply not been a barrier to entry.
Great and my second question is in terms of the Anson Cheung guidelines do you anticipate any future updates incorporating mirasol or any other data in the near future.
Yeah, So we anticipate with <unk> being the only study to show an overall survival advantage in a randomized phase III setting for a novel agent, we anticipate mirasol could move our Ela here.
Companion lifting from a to a to a category one and it would be the only medication in the NCC and platinum resistant treatment guideline that would have that level of evidence.
We also are anticipating that the piccolo data could support a.
And CCM compendium for later line platinum.
Platinum sensitive ovarian cancer for Mirv monotherapy.
And also we are generating three datasets at this point for <unk> plus Carboplatin. The <unk> study that is our sponsored study in low medium and high fr Alpha expressing patients.
As well as we are supporting two investigator sponsored trials Neo adjuvant study and the randomized phase II study in Germany led by Philip harder and those data could absolutely support companion listing as well.
Yeah, We also hope that we can move.
Sorry, the companion listing of the combination from two ways to do it for Mirv Bev.
Do you have a sense of timing for that.
Oh, well, we are aiming to make some changes for for the need to know and I hear monotherapy in October and similarly for the combination of Mirv Bev trying to lead to a yes, we will work with MCC and around their scheduled meetings.
Great. Thanks for taking my questions and congratulations once again.
Thanks.
Please standby for the next question.
Sure.
The next question comes from Andy Shay with William Blair. Your line is open.
Okay.
Congrats on the another blowout quarter.
It's been a pleasure working with you and wish you the best of luck.
So I have a question about kind of the strength of the community and non academic centers.
So I'm curious if you have a view on that or any sort of market dynamics, you're seeing there.
And I also have a follow up in terms of the R&D in your P&L.
Obviously.
Strength from from Ella here could fueled your R&D I'm just curious about maybe the.
The near and mid term vision about R&D whats.
What's in store, what do you expect the R&D to look like in the next three years.
In terms of P&L, obviously, you're pretty close to breakeven this quarter.
Just curious if that's the goal how do you think about.
Your income statement.
As <unk> continues to ramp.
Just incredible pace. Thank you.
Sure. Thanks, Andy So I'm going to ask is about the start and then Mike to talk about R&D and then some combination of Rene and I can tackle the P&L sure. So we're very pleased with the strong adoption in both the community and academic centers and if you remember early in the launch we thought the deca.
Centers, where to start first and community will follow what we had seen as a very strong adoption and community and that's testament to the unmet need and the target product profile of the drug.
We also see that kind of that mix has to follow normal process. They have to wait for the fintech committees they have to wait for hub.
Some centers.
They have the testing in house, but they have now starting to test and we are very pleased that pretty much all the major institutions.
The order intake here.
We have additional events that will create additional growth in both what we have the J code.
July 1st we have been including in pathways, and we think that that's going to continue driving the growth in both academic and known academic institutions in terms of the mix we think remain.
Relatively similar with more.
65% to 75% with more growth, maybe coming from academic institutions in the second quarter.
And Andy it's.
Mike regarding your question about continued investment in R&D.
Just two.
Remind us and it's nicely summarized we have.
Fraught ongoing lifecycle management program with Merck Rituximab, it's important for us to think about every woman with ovarian cancer.
Express folate receptor alpha to have.
Madison at the right time.
That will include investigation of our air and platinum sensitive ovarian cancer, you have already heard about that but I wanted to also remind you about <unk> five one which we continue to move through phase one development and has the potential to.
Broadly impact fr alpha expressing cancers, not only in ovarian cancer, but beyond cancer, such as endometrial non small cell lung cancer and others.
You've also heard about the continued investment payback in frontline AML and we look forward to those data informing.
Continued clinical development, there and then importantly, as a reminder.
Three.
Broad classes of.
Payloads with associated linker that.
Form the basis of our portfolio and <unk> noise the IGN.
And importantly, a camptothecin.
Group of compounds that.
I've yet to be formally tested in clinical development. So we look forward to.
Work, that's already ongoing with collaborators to bring forward novel antibodies Winkers and.
Test those payloads.
And a broad swath of.
Cancers so.
Really very committed across the spectrum and look forward to sharing those earlier progress of molecules.
Research as we move forward closer to IMT.
So Andy as Mike just articulated and we've also talked about.
The expansion globally of <unk>.
Here with the labeled indications, we do expect to invest heavily in the business.
In the coming years, so given cash guidance.
Say that we've got more than two years.
Cash and that is a reflection of both.
Existing balance sheet as well as the strength of the Ela here launch, but we aspire to be a fully integrated oncology company. We're fortunate to have one marketed product and three additional clinical candidates, but our goal is again to expand our preclinical.
Capabilities, we've done so incrementally with.
Number of partnerships and we look to continue that activity and also rebuild some in house capabilities.
Capabilities as it relates to our core.
Areas of expertise as Mike has as outlined so the focus is again.
International expansion for the business supporting the launch.
Lifecycle management and rebuilding.
Our preclinical pipeline, so again areas of investment on a go forward basis.
Great.
Helpful. Thank you so much.
Sure.
Please standby for the next question.
Yes.
The next question comes from Kelly <unk> with Jefferies. Your line is open.
Congrats on another great quarter and also please allow me to add my congrats to Anna.
My first question is for Piccolo trial, what kind of treatment duration could of weeks packed and also in the platinum sensitive setting is the propulsion of fr Alpha high patients seen as in the platinum resistant setting around 35% to 40%.
Thanks, Kelly So let me address your second question first the vast majority of patients who have participated in <unk> trials and who are receiving commercial ela here.
So based on archival tumor tissue testing so patients generally have de bulking surgery at the time of diagnosis and that's when their fr Alpha that's when they have tumor taken for fr Alpha testing. So the 35% to 40% is true regardless of what setting the patient isn't.
Going back to your first question about treatment duration for Piccolo.
You know these are later line platinum sensitive patients, but we know that platinum sensitive patients in general do better than platinum resistant patients.
Regardless of therapy, although again that does seem to be possibly changing for the subset of platinum sensitive patients post part who get more platinum.
That said we.
We anticipate the treatment duration for the Piccolo study is gonna be appreciably longer than for example in Mirasol worse array so stay tuned.
Okay, great. Thanks and also.
Paul Nice to me six in non small cell lung cancer cohort.
Curious is it pre specified interim analysis applied to a post PD one settings.
So it's not.
Typically in the post PD, one setting, but this is a phase one study where patients with non small cell lung cancer have had the appropriate prior therapies and the vast majority if not all of them have had a checkpoint inhibitor.
Okay, great. Thank you.
Please standby for the next question.
The next question comes from RK with H C. Wainwright Your line is open.
Thank you.
Congratulations.
Congratulations.
Nothing nothing like signing off on a high note.
I will certainly Miss you and especially on all the help from conversations that we've had in the last few years.
And.
Additionally, both my dog and I'm going to Miss you zoom.
Zoom calls.
Future zoom calls with immunogen.
So in terms of.
Expectations.
<unk>.
What additional analysis.
Could we see.
At the conference.
Yeah.
In Istanbul. This fall I think at the end of September and we have two abstracts.
That had been accepted for oral presentation.
In terms of additional subset analysis for Mirasol.
The the ones that will be focused on in this initial.
Right.
Yes.
Are the subsets based on number of prior lines of therapy.
As well as patients who have or have not had a prior PARP inhibitor.
So those are the key subsets because physicians are quite interested to understand.
Where to position Ela here in the treatment paradigm and I think the subset data will be very informative for them.
Thanks Anna.
Well it's true.
As you plan to file the NDA.
Neutral.
During the next.
Six months work.
How should we think about the commercialization there.
No.
Would this be.
Directly by yourselves or would you are you.
Speaking for a commercial partner there.
I'm just trying to understand the commercial structure that could be setup.
Yes.
Sure. So we plan to go direct.
The five largest markets and theres, a pretty leveraged approach that one can take by clustering. So we can add 11 additional market. So we expect to be direct in 16 markets.
In Europe of course that takes place over time, just given the cadence of reimbursement in those markets and then we would use distributors outside of the what we call the EU 16.
Sure.
Thanks, Mark Thanks for taking my questions.
Sure.
Please standby for the next question.
The next question comes from our stock.
Go Nordon with true with your line is open.
Hey, guys. Good morning, Ustica from tourist here and thanks for taking my questions I'm going to also offer my congratulations on a very elegant execution to the team and on a personal note Joanna we really launched coverage nine months ago, but are not limited time, it's been a pleasure to get familiar and appreciate the discipline. We wish you the best for your next adventure.
Yeah.
Just a couple of quick modeling questions for us here.
Clearly getting a nice boost from.
Michael off label use in the U S, but in general in oncology.
<unk> off label use in Europe can be as strong as you do get.
In the U S or do you think the doctor over there in Europe , we're going to stick to the script a bit more.
Second question is.
I'd like to test and see if we can't get any sort of color on.
On timelines with Lori ulcer.
One of the lessons that people are going to be looking at as well here after piccolo.
And then lastly, Marc when do you feel confident that you'll get enough samples from the from the claims data to give us a.
To give us some guidance on a product level basis daily here. Thanks, guys.
Sure.
<unk>.
The first question, it's not so much the <unk>.
<unk> that make good decisions with respect to the use.
Outside of the label in Europe is just the reimbursement there and it's very stringent there are very limited instances, where you can see off label coverage there and that's distinct from what we see in the U S market, particularly where.
<unk> R.
And the companion as we've seen.
With with Ela here.
Both in terms of no restriction on.
Prior lines of therapy in combination with Avastin.
They are fundamentally different markets as it relates to reimbursement and Thats what drives the.
The expectation should be that use there will be.
Within the within the label approved.
But the EMEA in terms of Gloria it's early days, so we havent given any any guidance there and then sorry. Your third question was.
Welcome.
Yeah Yeah.
I think it needs to be driven by two things are the two key factors that are in most opaque at this point, our duration of therapy, and really importantly, discontinuation, which of course are related to duration of therapy.
I think it's going to be.
Some time before we get to that I, certainly would expect us by.
The beginning of next year, when we all get together JP Morgan or in conjunction with our year end earnings call for the half.
A reasonably clear eye view on that.
As I say, we've got this demand study going and we'll see what that tells us as well.
Great. Thanks for taking my questions guys.
Yes.
Please stand by for the next question.
The next question comes from Joe Catanzaro with Piper Sandler Your line is open.
Hey, guys. Thanks for squeezing me in congrats on the nice quarter and congrats to you and a nice tenure here maybe just two for me I'm wondering if you had a sense around the cadence of new patient starts in <unk> and whether it was evenly distributed or not and Relatedly, whether you saw an uptick in usage in June and July following the Mirasol presentation.
At <unk> and then my second question, Mark you mentioned sort of the difficulty in modeling prevalent incidents I'm wondering sort of where you think you are in that curve and what metrics youre looking at that will give you an indication that youre shifting to majority usage in the incident population. Thanks.
Yeah.
Okay. So when it comes to the intense versus panic population and how we are looking at the patient data we have longitudinal data on claims.
The issue with that frankly is that its lagging 90 days. So we have very few patient data at this point, we get it.
And from DRG by lines of therapy.
And we are.
Tracking that and we think we need additional time before we can tell you what is happening there.
We had seen though that the municipal data do.
<unk> have any impact in terms of uptake of more patients as you saw in the second quarter and we also can see early signs from the claims that patients are moving to trade in earlier lines of therapy.
Pretty much as a science of sensor systems.
Okay.
Okay. Thank you.
Please standby for the next question.
The next question is from Jonathan Chang with Leerink Partners. Your line is open.
Thanks for taking my question congrats on the quarter and best wishes on next steps. Just one question for me. How are you guys thinking about potential business development opportunities for Ela here and strategic interest broadly. Thank you.
Yeah.
Yes, so what we've done with Elliott here as we've decided to go direct in the largest markets where we can.
With a modest investment support a robust launch so starting here in the U S and as we've talked a bit on this call going to Europe and markets, where that's not feasible for example in China, we've elected to go with with partners.
We're exploring partnerships for Japan.
In a similar vein.
Outside of that I think we plan to use distributors, because we think that with a time limited distribution agreement.
Can call back those when we're ready to move to a direct.
To a direct model so.
In terms of.
More broadly business development as we've talked we want to rebuild the front end of the pipeline and some of the deals that we've done obesity and more recently, a very small deal with <unk>.
<unk>.
Against the build the front end of.
The pipeline. So we're very excited about this business, we love the momentum that's been generated this quarter in the marketplace and Thats pair very nicely with data progress with the with the <unk>.
Pipeline. So we're excited about our long term prospects here.
Got it thank you.
Yeah.
I show.
I show no further questions at this time I would now like to turn the call back to Mark for closing remarks.
Great well. Thank you all very much for joining us today, we had a very strong first half we do expect to carry this momentum for the remainder of the year as we look to deliver more good days for our patients and importantly create value for our shareholders. So we look forward to keeping you updated on our progress.
As we move through the second half so thanks again for your time today.
This concludes today's conference call. Thank you for participating you may now disconnect.
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