Q3 2022 ImmunoGen Inc Earnings Call
The.
France will begin shortly to raise your hand during Q&A you can dial star one one.
[music].
Okay.
Good morning, and welcome to immune to Jim's third quarter, 2022 financial and operating results conference call.
Today's conference is being recorded at this time I'd like to turn the call over.
<unk> two <unk>.
Annabel Chen 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 and third quarter 2022 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 and Britt <unk>, our Chief Medical Officer, and Susan Chiller CFO .
During today's call people review of recent accomplishments for the business, our Q3 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.
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 in our other SEC filings, which are available at SEC Gov, and immunogen Dot com.
That I will turn the call over to Mark.
Good morning, and thank you for joining us today with approval expected on or before November 28, <unk> date, we've taken the last quarter to complete our preparations to launch <unk> talks about this month.
Just to put a finer point on these activities are highly experienced field team is fully staffed in our engagement with customers our distribution market access and patient support infrastructure is in place and we are buyers of commercial ready drug product and inventory awaiting labeling and packaging with this strong foundation in place we are ready to rapid.
We deliver birth to patients upon approval.
As part of our preparations we have recently updated our ovarian cancer market model, which draws on data from a couple of external sources. First this market is highly concentrated with roughly 4300 physicians treating just over 80% of ovarian cancer patients in the United States at launch we will be taking a targeted approach to <unk>.
<unk> adoption by focusing as an initial priority on a subset of 400 physicians that treat roughly one third of patients.
Looking to the market opportunity our estimate of the eligible patient population that is based on data from DRG, which indicate that there are 19500 drug treatable second through fourth line platinum resistant ovarian cancer patients in the U S. Each year, roughly 35% to 40% of these patients express high levels.
Fr Alpha and 75% currently receive single agent chemotherapy or non Bevacizumab regiments. This gives us a market opportunity of roughly 5200 patients for our anticipated initial label we.
We will also seek NCC and compendium listing for the Mirv Bev combination immediately after approval, which would add another 1800 fr Alpha high patients, giving us a total market opportunity of 7000 patients in the platinum resistant setting as.
As we will discuss later in the call. We have also initiated studies to move into recurrent platinum sensitive disease, which would bring the total U S market opportunity for mirv in recurrent ovarian cancer to above 11000 patients. We've included an updated market slide as part of our corporate deck posted on our website today.
On the topic of ongoing development, we expect to report topline data from the confirmatory Mirasol trial early next year and look forward to sharing those data as we pursue full approval in the U S and initial regulatory filings in the EU. We are also advancing our efforts to move mirv into platinum sensitive populations and have activated the first.
And both the glorioso and trials for 'twenty studies to address these patients.
Moving to our <unk> program in August we shared an important update on our pivotal cadenza study in frontline Bpd, Sienna and we will provide more detail on this study but in short following initial analysis showing significant activity in patients with de Novo disease, and those who presented with a prior or concomitant hematologic malignancy, we aligned with FDA that.
The efficacy Evaluable population will be in de Novo patients as a result, we now expect to report topline data in 2024 also of note we will be presenting initial data from RP that triplet expansion cohort in AML at Ash in December this will be the fourth consecutive oral presentation for <unk> at Ash and I will cover both the <unk>.
Mirv Antivax programs in just a moment.
Looking at the rest of the pipeline, we anticipate sharing initial data before year end from the phase one dose escalation of <unk> 96, our first in class Adam <unk> targeting ADC in co development with Macrogenics.
We've also made meaningful progress on our phase one study of <unk> 105, one and expect to put the first patient on study before the end of the year.
With that I'll turn the call over to Andy to provide additional color on our development programs Anna.
Thanks Mark.
Noted with mirv upcoming <unk> date, we are confident that we will be granted accelerated approval on or before November 28, given the totality of the data generated and in particular the strength of the pivotal survey data. We believe mirv has the potential to displace single agent chemotherapy as a new standard of care for patients.
With folate receptor alpha positive platinum resistant ovarian cancer.
Beyond the initial label the broader Mirv program continues to advance as we work towards full FDA approval for mirv in the U S generate data in earlier lines of treatment and position mirv as the combination agent of choice in ovarian cancer.
Reflecting these efforts we presented additional data, including patient reported outcomes from forward, one and population pharmacokinetic exposure response analyses of mirv monotherapy from Syria forward, one and our phase one trial at ESMO in September .
Last week at ESMO, we presented additional data from these studies characterizing the extended treatment benefit for patients with recurrent ovarian cancer.
Building. Upon these monotherapy studies, we are continuing to enroll patients in piccolo, our single arm study and folate receptor Alpha high recurrent platinum sensitive ovarian cancer, which may support label expansion in 2024.
Turning to our ongoing combination studies at Gcs, we presented encouraging data for both the <unk> plus bevacizumab and the <unk> plus carboplatin doublets in folate receptor alpha positive ovarian cancer.
<unk>, the <unk> plus bevacizumab combination demonstrated significant activity across a broad range of folate receptor alpha expression levels in patients that were bev naive or bev pretreated and regardless of platinum free interval.
I look forward to advancing this regimen in the platinum sensitive maintenance setting in the randomized phase III Glorioso study, which was recently initiated.
We are pleased with the recent progress of our second pivotal program is <unk>.
Or payback.
In an initial analysis of data from our ongoing phase II cadenza trial in frontline <unk> patients. We were very encouraged with the activity seen in both de novo patients and <unk> patients with a prior or concomitant hematologic malignancy with 11% to 13 or roughly 85% of patients achieving a.
Form of complete response.
In discussion with FDA, we aligned that the primary efficacy evaluable population will be in the de Novo BP DCM patients with CR CRC as the primary endpoint and duration of CR CRC as the key secondary endpoint for the study.
In addition, FDA encouraged us to generate data to support assessing CRH as an endpoint. Accordingly, we will also continue to enroll <unk> patients with PC AGM in cadenza to further explore the potential benefit of <unk> in this population.
Turning to our P that triplet with Azacitidine and <unk> in AML.
The data presented at <unk> in September demonstrated broad activity in adverse genetic subsets of relapsed refractory disease.
And at Ash in December we will present initial data from the Readouts in frontline unfit AML expansion cohort in an oral session.
And with that I'll turn the call over to Susan to cover our financial Susan Thanks, Anna for the third quarter of 2022, we generated $15 $4 million in revenue $8 million of which came from noncash royalty revenues and the remainder from license and milestone fees.
Operating expenses were $92 $8 million comprised of $59 $2 million of R&D expenses $33 $6 million of selling general and administrative expenses and we ended the third quarter with $395 million in cash on the balance sheet.
Our financial guidance for 2022 has been updated and we now expect revenues to be between 80 and $90 million.
Operating expenses between 320 and $330 million in cash and cash equivalents at year end between 230 and $240 million.
Revenue guidance does not reflect any potential product sales.
The increase in operating expense guidance is largely attributable to faster than expected hiring preparation for commercialization and strong clinical trial startup and execution.
We anticipate operating expenses to grow in the fourth quarter, but at a moderated pace relative to that seen in the third quarter.
We expect that our current cash combined with anticipated product and collaboration revenues will fund operations into 2024 with that we'll open the call for questions.
Thank you as a reminder to ask a question you will need the press star one one on your telephone please standby, while we compile the Q&A roster.
Our first question comes from John Newman with Canaccord Genuity. Your line is open.
Hi, there team good morning, Thank you for taking my question.
Just curious.
Regarding the topline data for Mirasol in early 2023, I'm just curious if you think in addition to the PFS endpoint.
But you might be able to talk a bit about.
Secondary endpoints, including overall survival, but also the patient reported outcomes tool that you are using thanks.
Okay.
Sure Hi, John .
So at the time, we have top line data early in 2023, we will report on the primary endpoint for Mirasol, which is progression free survival.
And at that point, we will have it.
Interim data were immature data on overall survival. That's one of the key secondary endpoints, we will still have information on.
Or are and DLR I think that's a little too early to anticipate having PRA data patient reported outcomes data.
Takes a bit more time to analyze.
And that will be coming.
And the second wave of data and we look forward to sharing top line data as early as possible in detail at a major medical meeting and I would anticipate that patient reported outcomes would be reported subsequently.
Okay, great. Thank you.
Thank you one moment.
We have a question from Michael Schmidt with Guggenheim Partners. Your line is open.
Hey, guys. Good morning, Thanks for taking my question.
It sounds like Mark that you sort of increase.
Patients assumption slightly if im not mistaken from your prior estimates for you.
Some of the initial target.
Target opportunity could.
Could you could you talk about how you think about the.
In this one.
Launch trajectory may play out.
Just wondering.
The testing dynamics.
How are you thinking about.
Adoption of.
The test perhaps relative to other <unk>.
Yes.
The breakup task.
Used widely in ovarian cancer and <unk>.
Thoughts you could share on sort of a more on that topic. Thank you so much.
Sure. So maybe just starting with the numbers so in conjunction with our launch preparations generating an internal forecast. We went out to you our principal vendors, which includes DRG <unk> Cantor health to.
To get updated <unk> data and then also better understand the distribution between single agent chemotherapy or combinations that don't use <unk>.
Susan Mab and then the segments of the population.
Our Bev combo treated and the net effect of that was the overall numbers, particularly in our initial indication of.
Second through fourth line platinum resistant.
Ovarian cancer patients increased also what we saw was.
A slight elevation in terms of the use of.
Single agent chemotherapy in these non Bev regimens.
That population and those are the principal things that drove.
The numbers up from from our prior forecast prior data that we shared in terms of the market opportunity and then sort of turning to launch and adoption. So.
Obviously, the first step here is to identify the patients fr alpha status and so testing.
The important first steps and that we've been working with Roche, we have for TARP labs that are up and running and ready to accept samples.
Upon approval. So these are centralized labs to which archival tissue and fresh biopsies, although those tend to be rare our stance.
Then patients fr Alpha status is determined and transmitted back too.
The trading.
Treating physician right now we estimate that that's a three to five day.
Turnaround we've talked about from the time a patient comes in.
At the time they are actually dose is probably going to be a couple of weeks.
<unk> for both the turnaround time for the test and then also scheduling for foreign infusion. So.
Look we have.
Physicians are telling US now are asking is now where can they send their samples.
We've seen awareness of fr Alpha increased significantly over over the last year.
We are out at all of the major Congress Congresses with additional mirv data either monotherapy or in combination and so awareness of the product is rising commensurately with.
Interest in the target so we.
We feel very good about where we are.
In terms of the launch on we've got the folks in the field right now profiling.
Accounts, so that they can understand things like ordering Seth and the like so I think we're in very good shape.
And are excited about the prospects I think we're a ways away from actually offer you any specific product revenue guidance given the the early stages of where we are today.
Great. Thank you so much mark.
Thank you and our next question comes from Ed Sir The route with BMO. Your line is open.
Great. Thanks for taking the question just wondered if you had any.
<unk>.
Labeling discussion negotiation discussions with the FDA for <unk>.
Accelerated approval and maybe just sort of generally where you are in sort of your current conversations with them and then secondly, just quickly if you could just remind us for LNG and one pipeline looks like phase. One was initiated if you could just sort of remind us where or how you plan to position.
This asset relative to <unk> rituxan that thanks.
Sure in terms of FDA, we've been actively engaged with the agency.
Form and substance of those conversations have been both positive and productive and we are highly confident and then approval on or before the <unk> date beyond that we really can't comment other than to say as I just.
Set the Michael we're ready to launch the product this month.
In terms of 151, so youll remember this is a molecule that's been designed.
Specifically with improvements into the antibody the linker and payload all of which are driving towards activity at lower levels of fr Alpha expression. So the initial positioning here is really twofold, one to get out the market segments.
America has been less active certainly as a monotherapy patients with medium and low levels of expression, where we see.
Certainly in the preclinical setting.
Significant activity with 151, and then in addition to that moving outside of ovarian cancer, where the indications like triple negative breast cancer are characterized generally with lower levels of fr Alpha expression and so that's how we're thinking about it.
We've initiated our first site with 151 and expect to put our first patient before the end of the year.
Great. Thank you.
Our next question is coming from Boris <unk> with Cowen Your line is open.
Great. My first question is on the Glorioso study can you comment on your discussion with the FDA over that study potentially being confirmatory trial in case, if mirasol does not reach.
Statistical end clients.
Hi, Boris so we aligned with FDA on the design of Glorioso, which is a randomized phase III study of Mirv, plus bev in the maintenance setting in recurrent platinum sensitive disease compared with Bevacizumab alone. We're really excited about that study it's initiated then.
Go on here.
When we aligned with FDA on the design of that study, we did not specifically address the potential for it to be a confirmatory study. However.
Stepping back.
Certainly it's appropriate to think that on the off chance that mirasol does not turn out the way we expect it to glorioso absolutely could serve as a confirmatory study if needed.
Great and maybe in terms of your labeling discussion.
What are your kind of thoughts on avastin for treatment requirements being in the label or potentially black box warning labels Division talks is that part of the discussion.
Have you asked.
It's been around that.
So as Mark mentioned, we've had productive and collaborative discussions with FDA during label negotiations and we look forward to sharing the details of the final label and what I can tell you at this point is that we're pleased with.
The tone and tenor of the conversations.
Great. Thanks, very much for taking my questions.
Our next question comes from Andy Si with William Blair. Your line is open.
Great Good morning, and thanks for taking our questions.
Maybe one just kind of similar to what Boris asked previously.
But with.
With focus on the commercial team. So obviously go again.
Right.
If we assume.
Approval there is two outcomes maybe be.
Label, that's more aligned with Syria or label, that's more aligned with.
With <unk>, so I'm just curious.
These two populations.
The vast experience store vast and agnostic populations, how much of a difference in terms of messaging.
The commercial team.
Be responsible to communicate.
As we kind of head into the <unk> date.
So the commercial team is not out talking about the product right now so they are in the accounts understanding ordering patterns patient flow that kind of thing, but there is no discussion of the drug.
At this point.
As part of the profile as you could imagine them target asking about patient flow use of prior avastin that sort of thing.
But again, there's no discussion of the of the drug per se.
Based on our prior experience.
We think roughly half of the second to fourth line.
Platinum resistant population will be bev naive as what we call it and then.
The handful of pad.
Bev and Thats just based on the outputs that we had.
From forward one.
In this setting so does that answer your question Andy.
Okay.
Yes, yes, yes, exactly great and then I have a follow up on.
On payback, so yesterday, obviously, the flick ITD data is very provocative.
And I think that's becoming kind of a standard mutation you look forward within the panel of molecular markers I don't know if you have a view.
Whether it's a worthwhile exercise to talk to the FDA about a potential expedited pathway just given the history.
Within that Submarket in AML.
And if so I'm curious if you could let us know if that discussion has taken place are planning in the future.
Sure.
Yes.
Thanks, Andy.
We really look forward to our oral presentation for our triplet data of <unk> plus another <unk> at Ash and what you are referring to is in our abstract we had 71 patients with relapsed refractory AML, where we see very encouraging data for the triplet overall and particularly in certain.
Subsets, including the naive patients as well as patients with a flit three ITT.
As you know there are flip three inhibitors that are approved.
And patients with AML with <unk>.
<unk> mutations also do quite well with Ben Asos and so.
I think it's certainly fair to say that our investigators are very excited with the activity that we're seeing specifically.
The overall response rate, we're seeing of 82% in the CR.
CR rate of 64% and I certainly think that's one option that's on the table for considering for further development, if we choose a very niche.
<unk>.
Thank you.
Our next question will come from.
Courtney <unk> with Barclays. Your line is open.
Thank you this is Peter in.
For for cooking.
Just on the expected turnaround in testing for Fr Alpha.
Just if you can kind of give us an idea of turnaround time.
The labs.
Signed up for the test.
<unk> trained for the test.
And kind of how you see the increasing overtime.
Sure.
Sure. So our expectation right now is three to five days in terms of the turnaround right now there are four labs.
That have been certified we call them TARP labs that we work with Ventana.
Ventana to validate those labs, so they are ready to receive.
Samples, we do expect over time. So this test is run on a ventana machine.
Machine called a benchmark ultra which is installed in the vast majority of.
Large institutions.
So we do expect over time that those institutions.
It will be trained on the test and then start running the test in house as opposed to sending samples out to the centralized labs.
Got you. Thank you and then just how do you do you need.
Need more of them signed up just whats your read through the existing four labs.
Yes.
Existing four labs will cover the entire country and have significant capacity.
If you think about this patient population they could they could run off 5200 patients every year.
Are there in terms of their capacity so capacity is not a constraint here its just the logistics of <unk>.
Access examples and getting them to the laboratories.
Thank you.
We've spoken about this before but just the.
The departure of Jos.
<unk> just if you could talk through the <unk> fund into replacement.
That causes any kind of uncertainty committed.
Submit a potential launch.
Sure. So obviously the timing here is unfortunate and I guess, we'd make three points here. The first is that this was a personal decision that was going to allow kristin to be closer to her home.
Is this is unrelated to the business. We are highly confident in an approval on or before the <unk> date, and lastly, and importantly, we thank her for this she is leaving us in great shape. So we have recruited.
Deep bench, we're pleased to have con talerico step into the interim role. This is someone with more than 30 years of experience in the industry. He has carried a bag he's worked in marketing.
He is just the consummate market access professional so he's got a breadth and depth of experience.
All of the critical.
Commercial functions and he stepped into the role and.
The team is very happy with them beyond that when we look at the field force starting at the top with Nicole Crawford again. This is somebody with 20 plus years of experience in the.
Industry.
Selling her last role radio pharmaceutical so.
Familiar with with.
Product construct like an ADC.
<unk> deep experience in solid tumors in heme malignancies.
<unk> marketing, so we've got a breadth and depth when we look at the diversity of the field force we've drawn from many.
The premier oncology franchises around the around the industry. So this is a very experienced team and.
Rattled by this kind of thing ready to go and I think.
Part of this is driven by the enthusiasm that we're seeing from our customer base right and so when you know you've got a product that people want your energized and when you walk around the halls of Immunogen and sales training meeting in Tampa two weeks ago.
People are site and so I think this is.
An exciting moment as I said, the timing with respect to Kristen is unfortunate, but we're ready.
Great. Thanks Luc.
We have a question from Kelly <unk> from Jefferies. Your line is open.
Thank you for taking my questions first of all Adam not EDC, what kind of value.
Presented with Barclays. Your line data and also where the data beaten Q2 guide of what a solid tumor types you could pursue in the next stage.
And secondly, during the launch preparation and I'm wondering have you heard any logistical challenges to coordinate always ophthalmologists to manage ocular tox. Thank you.
Yes, so <unk> 93, six as our Adam nine targeted ADC that we are in co development with with Macrogenics and we look forward to sharing data from our phase one first in human dose escalation study before the end of the year I think those data will help folks understand.
The thoughts for further development there in terms of tumor type.
Dosing schedule. So we look forward to sharing that before the end of the year.
Yes, and in terms of.
Ophthalmologist console. So we're fortunate to have worked with a number of centers already in conjunction with our clinical trial. So we've got those relationships that exist in many of our target centers beyond that.
The first ADC to come with the ocular events and so again.
As we are profiling accounts.
One of the key questions being asked is.
How are you doctor setup in terms of a referral this back to eye exams in conjunction with the administration of therapy and what we're finding is.
Those relationships are up and running and then we've also put together a standard messaging.
To help in the event that that those relationships don't exist that that they can get set up.
To support managing the ocular events that may arise in conjunction with therapy.
And one thing I would just add is that it.
Not just ophthalmologists, but eye exams can be done by optometrists, which has helped.
On the community setting.
Okay. Thanks.
Thank you one moment.
We have a question from Arthur he with H C. Wainwright Your line is open.
Hey, good morning, everyone.
Arthur on floor Okay.
Most of my question has been asked and I.
I just had one on the walk for Q1.
Would you remind us.
Whats the inclusion of threshold for the Fr Alpha expression for the phase one study.
And.
Based on that how.
Large of the addressable patient population compared to the mirv.
Thank you.
Yeah sure. So fr Alpha is expressed in 80% to 85% of ovarian cancers. So that's like almost all ovarian cancers and so in our 105, one first in human study, we are enrolling all ovarian cancer patients and we're collecting tumor tissue.
On everyone. So this really does have the potential to.
Impact and improve the lives of.
All ovarian cancer patients not just those with high fr Alpha expression.
With endometrial cancer that is the other type, particularly the high grade Crs subsets that has fr alpha expression and again at lower levels than for <unk>.
For Mirv, but is also really exciting tumor type for us to be exploring for 151 in our phase one study.
Oh. Thank you. Thank you for taking my question and congrats on the progress.
Thank you. Thank you.
Our next question comes from Daniel <unk> with Jpmorgan. Your line is open.
Good morning, everyone. Thanks for taking my question.
Previously you had mentioned STR cri rate of about 40% as exciting in the relapsed refractory setting of AML with the abstracts for ash showing your composite complete remission of 31% for the Pea that triplet how should we think about the data that's going to be presented at ash.
Yeah. So.
Triplet development.
In relapsed refractory AML is.
Really interesting because we need to really understand who our patients are and it's clear that the evolution of the treatment paradigm is ongoing and unfolding. As then as that is increasingly becoming the standard of care in the frontline setting.
So understanding the benchmark in the relapsed AML setting.
I would say an area of intense scrutiny for us at this very time, so that we can understand who the patients are who benefit most from our triplet I'd point out that we have a robust dataset at ash of 71 patients in our abstract.
You should expect to see even more patients in the oral presentation as well as details on who these patients are that will guide further therapy that that 40% finger in the wind is is really.
Good enough for initial thinking, but not not good enough for us to say, okay. What is really the bar in this patient population, where we see the most activity.
So that's where we're focusing our work internally as well as getting feedback from external advisors. So stay tuned for ash.
Great very helpful. Thank you very much.
Thank you and our last question comes from Jonathan Chang with <unk> Securities. Your line is open.
Hi, guys. This is peso appreciated on for Jonathan just wanted to ask about the pivot <unk> data coming up I wanted to confirm that strike. It looked like it was just relapse refractory youll be presenting frontline data.
Well and also wanted to ask what you see as the path forward for payback in AML.
Thanks for the question, we do anticipate having we will have frontline data.
At the oral presentation, we didn't quite have enough for inclusion in the abstract given the early cutoff date that was required for abstract submissions. So yes, you should anticipate seeing not just more relapsed refractory patient data is in the abstract but you should also anticipate seeing I would say a small but meaningful group of frontline AML.
Patients who have received our triplet.
I would also point out that as we have been developing the triplet knowing that others have stumbled in terms of toxicity, when adding a third agent to an already Milo suppressive than as a regimen.
Preceded I would say not with caution, but with prudence really exploring a 14 day regimen of <unk> and.
So the data that we've gathered in the frontline setting now is really allowing us to explore further activity of the triplet increasing the duration of then dosing up to the label to 28 days, which would guide further development and it's important as we think about the registration strategy.
Got it thanks for taking my questions.
Thank you and there are no other questions in the queue I would like to turn the call back to management for any closing remarks.
Great. Thank you, but this is an exciting moment for us we've made tremendous progress over the course of this year and we are very much looking forward to reconnecting with all of you within the months talk about an approval for <unk>, Bob Thanks, and have a great weekend.
This concludes today's conference call. Thank you for participating you may now disconnect.
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
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