IMGN - ImmunoGen Inc. (IMGN) Q1 2023 Earnings Call Transcript
2023-04-28 13:20:06 ET
ImmunoGen, Inc. (IMGN)
Q1 2023 Earnings Conference Call
April 28, 2023 08:00 AM ET
Company Participants
Anabel Chan - Head, Investor Relations
Mark Enyedy - President & Chief Executive Officer
Anna Berkenblit - Chief Medical Officer
Renee Lentini - Interim-Chief Financial Officer
Michael Vasconcelles - Executive Vice President of Research, Development & Medical Affairs
Todd Talarico - Vice President of Market Access
Conference Call Participants
John Newman - Canaccord Genuity
Michael Schmidt - Guggenheim Partners
Etzer Darout - BMO
Andy Hsieh - William Blair
Boris Peaker - Cowen
Peter Lawson - Barclays
Kelly Shi - Jefferies
Asthika Goonewardene - Truist
Joe Catanzaro - Piper Sandler
Presentation
Operator
Good morning and welcome to ImmunoGen's First Quarter 2023 Financial and Operating Results Conference Call. Today's conference is being recorded.
At this time, I'd like to turn the call over to Anabel Chan, Head of Investor Relations. Please go ahead.
Anabel Chan
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 first quarter financial results. This press release the recording of this call, and an updated corporate deck can be found under the Investors and Media section of our website at immunogen.com.
With me today are Mark Enyedy, our President and CEO; Anna Berkenblit, our Chief Medical Officer; and Renee Lentini, our Interim CFO; Michael Vasconcelles, our EVP of Research, Development and Medical Affairs; Isabel Kalofonos, our Chief Commercial Officer; and Todd Talarico, our VP of Market Access will also join us for Q&A.
During today's call, we will review recent accomplishments 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 risk outlined in our press release issued this morning in the Risk Factors section of our most recent annual report on Form 10-K and in our other SEC filings, which are available at sec.gov and immunogen.com.
And with that, I'll turn the call over to Mark.
Mark Enyedy
Thanks, Anabel. Good morning, everyone, and thank you for joining us today. I'd like to preface this call by saying that the focus of today's discussion will be on ELAHERE's commercial performance and on our ongoing development programs beyond MIRASOL. We expect to share top line MIRASOL data within the next couple of weeks, so we'll refrain from commenting on this trial and respectfully ask that you hold any questions.
We've made a very strong start to 2023 exemplified by the Q1 revenue for ELAHERE, the advancement of our clinical programs for four novel ADCs and the strengthening of our balance sheet by securing a non-dilutive credit facility with Pharmakon for up to $175 million.
Before moving to our launch update, I first want to thank our commercial and medical teams for their outstanding work bringing ELAHERE to market. In particular, I'd like to recognize Todd Talarico, who has served as our Interim Chief Commercial Officer over the last five months for the exemplary performance leading the initial stages of the ELAHERE launch. Todd? Thank you.
I would also like to welcome Isabel Kalofonos, who joined us on Monday to drive the continued success of ELAHERE leading our high-performing commercial organization.
On that note, building on a fast start to close 2022, our teams made notable progress across all four launch imperatives, as we work to position ELAHERE as the standard of care for folate receptor alpha positive ovarian cancer.
In the first full quarter since launch, we generated $29.5 million in net sales. We are very pleased with this performance and believe these results reflect early and accelerated recognition of the benefits ELAHERE brings to an advanced ovarian cancer population with high unmet need.
Uptake in the quarter continued to be broad and deep and we saw a significant percentage of accounts, with repeat orders complementing new patient starts. While academic institutions comprise our largest customers roughly 70% of orders during the quarter continued to come from nonacademic institutions and community-based oncology groups, and 80% of orders from new accounts came from those with no prior experience with ELAHERE.
Turning to testing. We continue to see strong demand for the FOLR1 diagnostic through our four central labs set up in collaboration with Roche. In addition, we added 19 new labs during the quarter and more than 20 additional labs are in the process of validation to run the test in-house. We estimate that roughly 5,400 FOLR1 tests were performed during the first quarter and that a significant percentage of these tests are for newly diagnosed patients.
In addition our data indicate that the folate receptor alpha positivity rate was between 35% and 40%, which is in line with our clinical trial experience. Regarding access, we are very pleased with how quickly payers have included ELAHERE and coverage policies aligned to our label. We ended the quarter with 55% of Medicare and 70% of commercial lives covered.
Finally, our customer-facing field teams continue to be highly active. As of the end of March, our commercial team has engaged roughly 85% of their priority targets. We've been pleased to see the impact of these interactions, with broader-than-anticipated uptake among target accounts, particularly in the community setting.
To complement these efforts, our medical affairs team has been highly engaged in providing a full suite of support services to ensure a positive start and continuation of therapy by our patients and their physicians. Reports from the field continuously relate enthusiastic feedback from clinicians regarding their experience with the product.
In summary, we are very pleased with our first full quarter of commercial performance. That said, we still have much to learn about this market. So we will refrain from providing revenue guidance until we have another quarter of experience and can more fully assess the factors driving adoption, adherence and the pace of growth including more fulsome claims and other data with respect to FR alpha testing rates and the mix of testing at initial diagnosis versus testing to initiate treatment monotherapy versus combination use, moving from prevalent to incident populations and duration of therapy and discontinuations.
So with that, I'll turn the call over to Anna to provide additional color on our ongoing development programs. Anna?
Anna Berkenblit
Thanks, Mark. We were pleased to present additional data from the SORAYA trial at SGO last month, highlighting the final median overall survival of 15 months with 37% of patients alive at 24 months as well as the antitumor activity of mirvetuximab across different subgroups. We were also excited to receive resoundingly positive physician feedback on ELAHERE at the conference. We are very proud of the work our medical affairs team has done in this area.
Let me now turn to the broader mirvetuximab development program, which has the potential to meaningfully expand the ELAHERE label. In January, we completed enrollment in PICCOLO, our single-arm trial of mirvetuximab monotherapy in recurrent platinum-sensitive ovarian cancer patients with high FR alpha expression. And we anticipate a readout on the primary endpoint of ORR before the end of this year.
As we look to position mirvetuximab as the combination agent of choice in ovarian cancer we are progressing two studies. The first is our Phase 3 GLORIOSA trial evaluating mirvetuximab plus bevacizumab maintenance versus standard-of-care bevacizumab maintenance in the second-line platinum-sensitive setting. The second is trial 420 a single-arm Phase 2 study evaluating MIRV plus carboplatin followed by MIRV continuation in platinum-sensitive ovarian cancer patients with low medium or high levels of folate receptor alpha expression. Both trials are up and running in the U.S. and we are working on opening them in Europe as well.
Moving to the rest of our pipeline. We remain on track to complete enrollment in our pivotal CADENZA trial of PVEK in frontline BPDCN this year and anticipate top line data in 2024. As a reminder last year we aligned with FDA that the efficacy-evaluable population will be in frontline de novo BPDCN patients and we also are continuing to enroll patients with a prior or concomitant hematologic malignancy to further explore the potential benefit of PVEK in this population.
For our AML program we progressed our 802 trial of PVEK in combination with venetoclax and azacitidine with strong recruitment in our cohort to evaluate up to 28 days of venetoclax per cycle in the frontline setting. This cohort along with our fully enrolled 14-day venetoclax cohort will help us optimize the duration of venetoclax for this triplets and guide pivotal development in frontline AML. We look forward to reporting data from these frontline cohorts later this year.
In addition in collaboration with Gilead, we are preparing to initiate a separate cohort in relapsed refractory CD123-positive AML to evaluate the safety and efficacy of a novel PVEK magrolimab doublet in the second half of the year. As for our earlier-stage assets on IMGC936 our first-in-class ADAM9-targeting ADC in co-development with MacroGenics we have completed dose escalation without reaching an MTD and selected a recommended Phase 2 dosing schedule of six milligrams per kilogram every three weeks. This was based on exploration of two schedules every three weeks and weekly across multiple dose levels.
In addition, we have prioritized the non-small cell lung cancer cohort and plan to provide an update after the protocol specified interim analysis is completed. Lastly, we commenced patient dosing in our Phase 1 trial of IMGN151 earlier this year and we are continuing dose escalation. This trial is designed to address a broader range of folate receptor alpha-expressing tumors with initial exploration in ovarian and endometrial cancers. So as you can see we're off to a great start in 2023 and look forward to advancing our pipeline through the rest of the year, with top line MIRASOL results anticipated in early May.
With that, I'll turn the call over to Renee to cover the financials. Renee?
Renee Lentini
Thanks, Anna. For the first quarter of 2023, we generated $49.9 million in revenue, including $29.5 million in net product sales of ELAHERE, $15 million of license and milestone fees and the remainder from noncash royalty revenues and R&D support fees.
Operating expenses were $91.6 million, comprised of $51.6 million of R&D expense and $40 million of SG&A expenses. We ended the first quarter with $201.2 million in cash on the balance sheet. And in early April, added $75 million with the drawdown of the initial tranche of the term loan facility with Pharmakon. Our financial guidance for 2023 has been updated and we now expect revenues, excluding product revenue from ELAHERE to be between $45 million and $50 million and operating expenses between $320 million and $335 million.
We expect to provide ELAHERE product revenue guidance later this year. The increase in our revenue guidance is a result of recognizing a $15 million upfront fee in the first quarter, related to our license and option agreement with Vertex, as no deferral was required.
Additionally, the company increased its operating expense guidance to reflect greater spend in support of ELAHERE's current success and expected growth trajectory. We expect that our current cash, inclusive of the $75 million received pursuant to the term loan facility with Pharmakon and combined with anticipated product and collaboration revenues will fund operations into 2025.
With that, we'll open the call for questions.
Question-and-Answer Session
Operator
[Operator Instructions] Our first question comes from John Newman with Canaccord Genuity. Your line is open.
John Newman
Hi guys, good morning. Thank you for taking my question. Just had two quick questions. First one is regarding top line data for MIRASOL. Should we still expect focus to be on PFS with some discussion of immature overall survival data? Second question on ELAHERE. Obviously, you are only promoting for the labeled indications, but curious, if you can talk at all about combination use with Avastin? Thank you.
Anna Berkenblit
Sure, John. So, we're on track for top line data from MIRASOL early May. And as we've stated previously, we'll have data on the primary endpoint progression-free survival, as well as key secondary endpoints, including overall survival. There will be enough overall survival events that it will be mature enough for the regulators to review.
Mark Enyedy
Right. In terms of the market uptake John, this will be a little bit of a recurring theme on this call which is we've got very limited data at this point. We have claims data for less than 100 patients. And so, it's difficult to sort of articulate any conviction around trends and so on. What I will say is, we do see both monotherapy and combination use in the database, which is of course encouraging to us, but can't comment any further with any conviction.
John Newman
Okay. Great. Thank you.
Operator
Thank you. Our next question comes from Michael Schmidt with Guggenheim Partners. Your line is open.
Michael Schmidt
Hey guys, good morning. Thanks for taking my questions and congrats on this very impressive first quarter result. What are you seeing right now in terms of repeat customers -- repeat patients versus new patients starting on therapy in the first quarter? And do you have an early read on duration relating that it's only been a few months at this point.
Mark Enyedy
Yes. So, obviously, we do see a significant percentage of repeat orders coming from the accounts. Again, as I say, it's a little bit -- we just were four months in. And as I said we've got 100 patients worth the claims data. So, what we can see are the accounts that are ordering have a very healthy percentage of new accounts coming online and a significant percentage of repeat orders. But it's hard to sort of take that down to the patient level. So again, no strong sense at this point in terms of duration of therapy.
Michael Schmidt
Okay. And then just thinking about the trajectory over the rest of the year, since 1Q was obviously above our expectation. And anything noteworthy as we head into early April data, I think you mentioned through a prevalence versus incident shift perhaps anything noteworthy as it pertains to the size of the addressable population or any other market dynamics as we think about the trajectory of the rest of the year?
Mark Enyedy
Yeah. So maybe a few high level comments here. As we see the data emerging and assess on the performance, the execution here, the strength of the launch is really being driven by four factors. The first is unmet need. Bears repeating that this is the first new drug specifically approved for platinum resistant ovarian cancer in almost a decade, 75% of these patients receive single-agent chemotherapy, which is characterized by low overall response rates with short duration and significant side effects, which really leads us to the second factor, which is the product profile for ELAHERE where we see a meaningful improvement over the standard of care with upwards of 3x in terms of the overall response rates and a manageable safety profile.
So against that what we have is a very receptive audience both in terms of our physicians and patients who recognize the benefit that that profile confers for this population and the innovation that we're seeing -- that we're bringing to the space. Equally important this is a physician population that is acclimated to testing.
So between BRCA mutation testing and HRD testing. This is a prescriber base that's accustomed to ordering tests for their patients. And so we see that with the uptake in testing, which continues to be very robust.
And then finally one of the questions going into this launch was how are you going to manage the baseline ocular screening? And happily TIVDAK preceded us by a pretty good margin going into this market. So again what we find across the prescriber base is that physicians already have established referral basis for ocular exams. And so we've been able to ride on the back of that.
And so -- with those factors in mind, our team has done an excellent job executing both prior to approval as it relates to education of the market and then post approval and really becoming and establishing ourselves as a valued partner to the ovarian cancer community. And what that has translated into a strong demand for testing broad and deep adoption. You've heard us talk about the uptake in the community and in particular physicians with no prior experience with the drug. And in addition to that, we see rapid payer coverage.
One important point to make is this is not inventory. So I just want to stress that we operate in a drop-ship model, so it's going directly to the customers and there's almost no inventory in the channel. We have one specialty firm set up for those who are not wanting to buy and bill, but it's a nominal amount of vials there. So as we look ahead, obviously, the revenue this quarter was 10x what it was last quarter. And I think it's safe to say that it will not continue to scale linearly.
That said, we just have a lot to learn about this market and we think that the pace of growth here is going to be driven by a couple of key factors. The first is testing rates and the mix of patients being tested in particular whether they're newly diagnosed patients or for patients that are ready to initiate therapy. And we still haven't sorted that out. I mean, the way this has to work is looking at where the tests were ordered from and then seeing where the drug is ordered and matching those two things up. There's a little bit of lag in terms of the reporting of the testing data. So it's something that requires additional data to sort through.
Secondly, monotherapy versus combination therapy. Combo patients tend to respond at higher rates and stay on therapy longer. But today the claims data that we have available is limited, moving from the prevalence to the incident population. So this gets a little bit complicated Michael. But when you look at ovarian cancer overall, the prevalence is over 230,000 women living with ovarian cancer in the US.
We don't use the prevalent population for modeling. Instead we rely on data that we buy from DRG that provides us with estimates of newly diagnosed patients stratified by line of therapy. And then we use other sources to assess the split between platinum-resistant and platinum-sensitive and also other parameters. But when you add up the newly diagnosed patients in first line through sixth line irrespective of whether it's platinum sensitive or platinum resistant, that's 54,000 patients each year. So you see the difference between this prevalent population and the annual incident population.
And so while using annual incidents, we think it's a better approach to modeling in advanced cancer population, particularly before ELAHERE with median overall survival of less than a year. It really doesn't account for launching into this prevalent population with limited treatment options. So the prevalent population is larger but we have no good data at this point to tell you how to stratify that population by line of therapy and whether they are platinum-sensitive or platinum resistant. But for sure, it's a larger population and we do capture that in the early going here as we're penetrating into the market. So that's a really long answer to your question but that's the best of what we have right now.
Michael Schmidt
All right. Thanks for all the detail, Mark.
Operator
Thank you. Our next question comes from Etzer Darout with BMO. Your line is open.
Etzer Darout
Great. Thanks for taking questions and congrats on another strong quarter here. I just maybe if you could comment at all on sort of what you're seeing sort of exiting April versus sort of the first three months of the year kind of realized it's early – just wanted to kind of understand maybe some of the momentum exiting the first quarter and you're now exiting sort of the April month? And then I have a follow-up.
Mark Enyedy
Yes. So one of the things we will avoid doing is commenting during the quarter on the quarter with any degree of specificity. I will say just to allay any concerns that we see continued momentum and continued growth of the product in April but we're going to stay away from that. We're going to report our numbers on a quarterly basis in regular order to avoid a tone of this kind of conversation so...
Etzer Darout
Got it. And then maybe if you could give a little bit of feedback on sort of how physicians are testing and maybe the results that they're getting for sort of testing a folate receptor alpha in newly diagnosed ovarian cancer patients. Just sort of curious sort of the testing and sort of how they may or may not sort of use those results.
Mark Enyedy
Todd?
Todd Talarico
Yes. The testing up to this point has been very robust. As Mark mentioned we've had over 5400 tests this quarter. What we're seeing in the community and the physician population is that they're moving more from a treatable patient and into the patient population where newly diagnosed ovarian patients. So each of those centers are uniquely different but we're also seeing a lot of certification of labs into those markets at this point. So Mark mentioned, testing has been very well received. Physicians are quickly acclimating to it and we've seen very little pushback on the testing requirements.
Mark Enyedy
Maybe just describe a little bit what the results that a physician gets when they get the results back. What was your question was it Etzer or...?
Etzer Darout
Yes. Just one curious around sort of the testing of newly diagnosed patients versus sort of testing in kind of the platinum-resistant ovarian cancer population and sort of maybe the reasons or the dynamics why those physicians are running the test?
Mark Enyedy
Got it. Yes.
Anna Berkenblit
Yes, sure, Etzer, hi. So when physicians initially diagnose the patient, most patients do get initial debulking surgery. That's when they have tumor tissue sent to the lab. They're already planning to check for BRCA mutations in the tumor. They're also already planning to check for homologous recombination deficiency or HRD. So their thought process is hey, let's check for folate receptor alpha as well. And from our perspective that's really helpful so that for those patients who unfortunately do relapse they'll know whether or not at some point ELAHERE will be a treatment option for them.
Etzer Darout
Got it. Thank you.
Operator
Thank you. Our next question comes from Andy Hsieh with William Blair. Your line is open.
Andy Hsieh
Great. Well congratulations to everyone at ImmunoGen for the spectacular ELAHERE launch. My questions pertaining to the commercial launch. So, first is do you have a sense of the magnitude of ELAHERE penetration both in the labeled population and also in the compendia-listed population.
Secondly, from a physician feedback perspective I just wanted to dig a little bit deeper into what is driving the uptake? Do they tell you about maybe longer more deeper disease control tolerability? And is there a difference within the academic or community settings?
Mark Enyedy
Well, on the first question, it's really too early for us because our claims data is not robust enough or mature enough for us to triangulate the data to provide you the understanding of the patient population whether it's against the NCCN 2a or 2b positioning. So, too early for us to provide that. You might want to answer Anna.
Anna Berkenblit
And then in terms of what's driving the update let me just build on what Mark said initially around the unmet need here and what physicians expect with available therapies versus what they know about ELAHERE based on our clinical trial data.
Patients with platinum-resistant ovarian cancer their median overall survival is about a year plus or minus a month or two. And with available therapy single-agent chemotherapies give you a response rate in the -- around 10% range. So, physicians when they're taking care of these patients they're not really expecting responses. They're hoping for stable disease and they want to give their patients drugs that are well tolerated.
And by the time you have platinum-resistant disease, single-agent chemotherapies each has their own toxicity profile. And so based on that they know that with ELAHERE for high FR alpha patients the response rate is going to be over 30%. The vast majority of patients have stable disease and also the duration of our responses is quite long approaching seven months.
And so in that context then they talk about the tolerability profile and patients really like the fact that you don't lose your hair with ELAHERE. And it's a convenient once every three-week schedule as opposed to weekly or daily times five.
So, I think it's really highlighting the unmet need and the fact that there's been nothing approved in the space for about 10 years. So, I think that's really what we're seeing. And if you engage with physicians who take care of these patients that's what you'll hear from them.
Andy Hsieh
Great. Thank you. And Anna can you do you mind talking about the interim analysis for IMGC936 just in terms of what that entails? Thank you.
Anna Berkenblit
Yes. Sure Andy. So, it's a standard Simon Two-Stage Design. We have an initial stage. And once we're done enrolling those patients we would then continue enrolling to have a larger single-arm cohort of patients. And so after we pass that interim analysis we'll share data.
Andy Hsieh
Great. Thank you.
Operator
Thank you. Our next question comes from Boris Peaker with Cowen. Your line is open.
Boris Peaker
Great. Thanks. And let me add my congratulations on excellent results. I guess first I just want to probe a little more on the testing. I just want to confirm are you still paying for all the folate receptor alpha testing? And do you have kind of a quantitative sense of what fraction of the testing specifically being in patients that are eligible for ELAHERE versus others that are earlier on and are not immediately eligible for ELAHERE?
Mark Enyedy
Yes. So, we do pay for a significant percentage of the tests today those that are performed at what we call the TARP labs. Those were the centralized labs that we set up at just prior to launch.
As we've mentioned on this call, a number of these tests are being taken in-house. So, the large institutions that have the BenchMark ULTRA machine from Roche that runs this assay. And those are not tests that we are currently paying for. We do see potential opportunity to expand the centralized testing. We'll offer the subsidies for those tests as well. But again, this is roughly $300 for us. So when we think about the investment here and lowering the barriers to prescribing, we think this is an important element of the story. And as I said, we have a prescriber base here who's very accustomed to ordering tests for their patients in the first instance.
As before, we do not have any sense of the -- how many of these tests are being performed for newly diagnosed patients versus those who are ready to initiate therapy. It's just a tricky analysis to look at the folks that are ordering the test versus the accounts that are ordering drug in an inability to match physicians and so on. So we just don't have that visibility at this time.
Boris Peaker
Got it. And my second question is on the vision toxicity, are you collecting any data that you could kind of get a better sense of exactly how this is playing out in the real world how -- what the dropout or discontinuation rate is or any other kind of observation around managing the side effect?
Anna Berkenblit
So we've done a really nice job building on what TIVDAK started in terms of connecting oncologists with eye care professionals for us. We do have a post-marketing requirement for a study looking at ocular adverse events. And so I think that study may down the road give us a sense. But again, that's in the clinical trial context, not within the real world as it is. So I think that really emphasizes the importance of our medical affairs team, going out there and engaging with physicians and understanding what they're experiencing. We have sort of a continuous quality improvement effort if you will and as we're hearing feedback, we're adjusting on how we're engaging with sites to make sure they have the information that they need to optimize management of their patients. And I would say that's gone really well.
Michael Vasconcelles
And Boris, this is Mike. The only other thing I'd add at this point is we -- in our post-marketing safety surveillance, we've seen nothing that is distinct at all from the clinical trial experience.
Boris Peaker
Great. Thank you very much for taking my question. Congratulations again.
Michael Vasconcelles
Thank you.
Operator
Thank you. Our next question comes from Peter Lawson with Barclays. Your line is open.
Peter Lawson
Great. Thanks so much. Offer my congrats as well on the meaningful revenue. Just feeding off the last question, what's been the feedback from physicians around ocular toxicity?
Anna Berkenblit
So the feedback really has been that the materials that we've provided them have been incredibly helpful, so that they know what to expect and how to counsel their patients. And we have patient-facing materials, we have materials for oncologists and for eye care professionals.
Michael Vasconcelles
Yeah, it's been -- this is Mike. It's been a really nice partnership to work within the eye care professional community and create the partnerships with the treating physicians. And as Anna said, it's becoming quite routine at this point in terms of thinking about making those connections clinically before a patient starts on therapy. And as Mark had mentioned, we also had a nice foundation given prior therapeutics in the space.
Mark Enyedy
Just keep in mind that we have on staff two ophthalmologists working here -- yes, working here at ImmunoGen. And so as Mike was alluding to when we get noticed that an account has ordered, we dispatch the team to educate on the ocular management and if need be provide some support for referrals and the like, but the networks are pretty well established here. But as I said, it's important. We've got eye care professionals here on staff which has really I think helped in terms of making this a seamless therapy initiation and getting the baseline exams and any necessary follow-up.
Peter Lawson
Perfect. And then just if you could make any comments around the revenues performance kind of month-by-month in 1Q. And then, whether these patients you think are kind of early line or late line just that would be great to get some details around where those patients are in the journey.
Mark Enyedy
Yes. So we're going to stay away from monthly revenue. You will appreciate that it's growing and continues to grow. And then, sorry to your second question, what's that? Yes. As I say, we've got less than 100 patients worth of claims data at this point, Peter.
And so, I think it's hard to match that against the totality, the experience that we have at this point to give any sort of definitive guidance. Obviously, there are some early trends, but we would much prefer to have this product in the market at least six months before we start sort of parsing the data in a way on a call like this.
Peter Lawson
I guess, if there's any kind of anecdotal commentary from physicians, whether they're kind of content putting early line patients on therapy or whether they kind of reserve it as a very late-line therapy that would be great.
Mark Enyedy
Yes. I don't think they're approaching this as a salvage therapy. I think that, what they're looking for are patients who are FR alpha positive and looking at what the choices they have for one of those patients. And I think when you've got an FR alpha patient they're looking to put this patient on drug irrespective of their line of therapy.
And the NCCN guidelines were helpful in this regard in terms of not confining the recommended use of the drug by line of therapy. So that's militated in both directions in terms of later line patients, but also earlier line patients.
Peter Lawson
Great. Thanks so much.
Operator
Thank you. Our next question comes from Kelly Shi with Jefferies. Your line is open.
Kelly Shi
Congrats on the stellar Q1. The volume on the community versus academic center was mentioned stable at 70:30 versus Q4. I'm curious if this 70:30 is also the split of patients seeking for treatment at our community center versus academic in real world. The second question is for the ADAM9 ADC program. Is the data update in Q2 still remain on track? Thank you.
Todd Talarico
Yes. So if I'm clear, the question is in relationship to the mix from community to academic. Okay.
Kelly Shi
Yes.
Todd Talarico
Yes. So the -- okay. Right now, I think the community has come in stronger than we anticipated. And I think the academics are growing. So we're starting to see the academic centers start to carry higher volume across our customer base. We have roughly about 400 accounts that are currently ordering.
But the academics have taken a little longer, I think, mainly because we've seen P&T reviews, formulary placement, development of order sets EMRs. There's been a number of things in the ocular management protocols to be put in place. So I can't really say that there's been a real trend directionally that community will be the key driver, but I think that mix will shift over time.
Anna Berkenblit
And then to your second question Kelly, regarding IMGC936, we will share data once we have passed the interim analysis, as I mentioned from the first stage of the Simon two-stage design. The exact timing of that is really going to depend on the enrollment and then the follow-up, so that we have a full data set to share.
Kelly Shi
Okay. Thank you.
Operator
Thank you. And our next question comes from Asthika Goonewardene with Truist. Your line is open.
Asthika Goonewardene
Hi. Good morning, guys. And I'm also going to offer my congratulations on a very well-executed first quarter sales here for ELAHERE. So, Anna, we've spoken in the past a little bit about this, but I just wanted to check back against that as you're getting more patients, what are you seeing in the -- excuse me, I got a frog in my throat here. What are you seeing in terms of the resistance mechanisms to ELAHERE that are emerging? I understand its early days, but [indiscernible] hope to be in a position to maybe give us more color on that. And then, also in the -- on the commercial uptake side of the ELAHERE, just wondering if you can provide us any color on the uptake in -- among medical oncologists versus Gyn Oncs. Thanks, guys.
Anna Berkenblit
Yes. So we're certainly interested in mechanisms of resistance to ELAHERE. ELAHERE has a tubulin-directed payload. The data that we've generated were a few years ago presented at SGO where, we called it the biopsy cohort and all patients who were enrolled had a post-treatment biopsy after two cycles. We actually had to over enroll that cohort, because so many patients had such nice rapid tumor shrinkage. There was nothing there to biopsy.
But for those that we did get that post-treatment biopsy, we showed that there was no rapid down regulation of folate receptor alpha. We did have an optional biopsy at the time of progression. As you can imagine most patients when they're being told the drug is no longer working for them are a little less interested in subjecting themselves to a biopsy.
So I think as we manage the life cycle of ELAHERE, we will continue to learn from a scientific perspective to better understand what mechanisms of resistance may occur. That being said, the duration of therapy that we are seeing overall, and particularly in the patients with a confirmed response, really suggests a meaningful benefit to patients.
Todd Talarico
And if I -- I'll jump in on the question specifically around Med Onc to Gyn Onc community. At this particular point, the majority of our Tier 1 physicians that we launched into were primarily gynecologic oncologists. And we've had strong interest and feedback from that community.
We've had about 81%. Those customers have been seen by our field reps, and overall we've had over 900 customer interactions with face-to-face or presentations but some of those are a combination of Med Onc and Gyn Onc.
The medical community really actually manages the disease over time. So we do see some Gyn Oncs that will probably actually work with the patient and transition them over. And again, I think the community positioning you'll see more medical oncologists treating these patients, based on their comfort level with the product over time.
Operator
Thank you. Our next question comes from Joe Catanzaro with Piper Sandler. Your line is open.
Joe Catanzaro
Hey, guys. Thanks so much for taking my questions, and my congrats on the really nice quarter here. Maybe first question, and I hate to ask it, because I think Mark you said you wouldn't provide any details on this. When you look at repeat orders and the timing and number of vials requested, does that provide any early insights into extent of dose interruptions or reductions. Maybe you could say whether that's tracking in line with clinical experience or not?
And then, on the ADAM9 program, I think I recall you had previously guided towards initial expansion data including both lung cancer and triple negative, but it sounds like we'll now just see lung. So, wondering if you could just speak to your updated thinking on TNBC. Thanks.
Mark Enyedy
Yes. So -- what we see on a daily basis is the orders that are coming in and we can assess that again -- so which of those are new accounts and which of those are repeat orders. It's not patient-level data. And obviously, one of the points that we just want to make here is that our largest accounts are our academic accounts and the uptake there has been very strong.
And in terms of having those accounts come online it's related to some of the points that Todd was making around their P&T committees and so on. But just to be clear, the uptake there is ahead of our expectations and they are in fact our largest customers.
But it's hard in that context to tell whether you've got a new patient from one of these larger accounts or whether you've got a repeat patient. And so -- and then separately, at some point we will see accounts not ordering. And after a certain period of time, I think you can assume that you've had a discontinuation there.
But again, given that these data are being reported to us from a claims basis with a 60 to 90-day delay, it's really hard to get at the discontinuation rate. And again, in the larger accounts, it's going to be confounded by multiple patients. And so, that's where we are today. Obviously, as we accumulate more experience, we'll have a better sense of those things.
Anna Berkenblit
And switching back to your second question about IMGC936 to ADAM9 targeted ADC --our initial thoughts were triple-negative breast cancer and non-small cell lung cancer. And what I can tell you is that we've prioritized non-small cell lung cancer and look forward to sharing data after we've completed the first stage of the Simon Two-Stage design.
Joe Catanzaro
Okay. Got it. Thanks so much.
Operator
Thank you. And our last question comes from Jonathan Chang with SVB Securities. Your line is open.
Unidentified Analyst
Hi, guys. Thanks for taking our question. This is [indiscernible] on for Jonathan and congrats on the progress this quarter. Just wanted to ask I saw that you revised the OpEx guidance up a little bit. Could you describe what are the drivers going into that?
Mark Enyedy
Renee?
Renee Lentini
Sure. We obviously are looking as it relates to OpEx we've seen with ELAHERE in support of the growth trajectory and the success we are spending more than expected. And we reflected that in the guidance for the year.
Unidentified Analyst
Got it. Okay. And then on the PICCOLO study could you guys discuss what's the regulatory bar for indication expansion in that setting?
Anna Berkenblit
Yes. So PICCOLO is our monotherapy mirvetuximab trial in later line platinum-sensitive disease. The regulatory bar there I would say is evolving in the sense that there are more and more later line platinum-sensitive patients now with really widespread adoption of part maintenance in the frontline and sometimes in the recurrent platinum-sensitive setting, which is essentially artificially extend to platinum-free interval.
We know these patients unfortunately have cross resistance to these agents that damage DNA. So even after you've had a PARP inhibitor more and more data are coming out that even though you technically are platinum sensitive based on the time from last dose of platinum your tumor is not as sensitive to platinum-based chemotherapy as it would have been in the pre-PARP days.
So that actually is impacting what our thoughts are around expectations for available therapy. And in fact it may be that these patients will do worse than they would have again in the pre-PARP era. We're working to assemble the data that are emerging to help establish what that benchmark could be. I would anticipate we would need to get very solid alignment with FDA on what that benchmark would be for us to proceed with a single-arm study for accelerated approval. And I would say that is still evolving.
Unidentified Analyst
Got it. Thank you for taking my questions.
Operator
Thank you. We have a follow-up question from Peter Lawson with Barclays. Your line is open.
Peter Lawson
Great. Thank you so much. Thanks for the follow-up. Just -- and if you could remind us again about the studies that you could use as a confirmatory study beyond MIRASOL and what the -- if the FDA if you have spoken to the FDA about those studies?
Anna Berkenblit
Sure. So if needed GLORIOSA potentially could support -- could become the confirmatory study. And the reason I say that is it is up and running. We have discussed the design with FDA and it's a randomized Phase 3 study in a different setting in the recurrent platinum-sensitive maintenance setting. So certainly it could serve as a confirmatory study. However, we have not engaged with FDA on that potential. It's really not a good idea to engage in what is conversations with FDA. And so at this point our focus is on MIRASOL data early May.
Peter Lawson
Got you. And so you'll be well positioned to start those conversations if needed with GLORIOSA?
Anna Berkenblit
Yes.
Peter Lawson
Thanks so much. Thanks for the follow-up.
Operator
Thank you. There are no further questions. I'd like to turn the call back over to Mark Enyedy for any closing remarks.
Mark Enyedy
Great. Well thank you all for joining us again today. We are very pleased with the start we've made with ELAHERE and partnership that we're building with the ovarian cancer community. And we look forward to speaking with you soon to provide the results from the MIRASOL study. Thanks.
Operator
Thank you for participating in today's program. This does conclude the program and you may now disconnect. Everyone, have a great day.
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ImmunoGen, Inc. (IMGN) Q1 2023 Earnings Call Transcript