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spk43: 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 Annabelle Chan, head of investor relations. Please go ahead.
spk06: 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 Ennedy, our President and CEO, Anna Birkenblit, our Chief Medical Officer, and Rene Lentini, our Interim CFO. Michael Vasconcellos, our EVP of Research, Development, and Medical Affairs, Isabella Calafonos, our Chief Commercial Officer, and Todd Tallarico, 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 risks outlined in our press release issued this morning, in the risk factor section of our most recent annual report on Form 10-K, and on our other FCC filings, which are available at scc.gov and immunogen.com. And with that, I'll turn the call over to Mark.
spk13: Thanks, Annabelle. 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 Elihir's commercial performance and on our ongoing development programs beyond Mirasol.
spk14: 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 Elihir, the advancement of our clinical programs for four novel ADCs, and the strengthening of our balance sheet by securing a non-diluted credit facility with Pharmacon for up to $175 million.
spk13: Before moving to our launch update, I first want to thank our commercial and medical teams for their outstanding work bringing Elihir to market.
spk14: In particular, I'd like to recognize Todd Tallarico, who has served as our interim chief commercial officer over the last five months for the exemplary performance leading the initial stages of the Elihir launch. Todd, thank you. I would also like to welcome Isabel Califanos, who joined us on Monday to drive the continued success of Elihir 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 worked to position Elihir 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 Elihir brings to an advanced ovarian cancer population with high unmet needs. 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 non-academic institutions and community-based oncology groups, and 80% of orders from new accounts came from those with no prior experience with Elihir. 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 FOLAR1 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 Eli here 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?
spk37: Thanks, Mark. We were pleased to present additional data from the SREA 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 anti-tumor activity of Mervituximab across different subgroups. We were also excited to receive resoundingly positive physician feedback on Elihir 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 Mervituximab development program, which has the potential to meaningfully expand the Elihir label. In January, we completed enrollment in PICOLO, our single-arm trial of Mervituximab 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 Mervituximab as the combination agent of choice in ovarian cancer, we are progressing two studies. The first is our phase three Gloriosa trial evaluating Mervetuximab 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 two study evaluating Merv plus carboplatin followed by Merv 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 PVEC in frontline BPDCM 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 the NOVO BPDCM patients, And we also are continuing to enroll patients with a prior or concomitant hematologic malignancy to further explore the potential benefit of PVEC in this population. For our AML program, we progressed our 802 trial of PVEC 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 triplet 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 PVEX nagrolumab 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 two dose and 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 commit 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?
spk07: Thanks, Anna. For the first quarter of 2023, we generated $49.9 million in revenue, including $29.5 million in net product sales of Eliher, $15 million of license and milestone fees, and the remainder from non-cash 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 Pharmacon. Our financial guidance for 2023 has been updated, and we now expect revenues, excluding product revenue from Eliher, to be between $45 and $50 million. and operating expenses between $320 million and $335 million. We expect to provide Eliher 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 Eliher'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 Pharmacon, and combined with anticipated product and collaboration revenues, will fund operations into 2025. With that, we'll open the call for questions.
spk43: If you'd like to ask a question, please press star 1-1. If your question has been answered and you'd like to remove yourself from the queue, please press star 1-1 again. Our first question comes from John Newman with Canaccord Genuity. Your line is open.
spk17: 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 the focus to be on PFS with some discussion of immature overall survival data? Second question on ELLA here, obviously, You are only promoting for the labeled indications, but curious if you can talk at all about combination use with Avastin. Thank you.
spk37: Sure, John. So, we're on track for top-line data from Mirasol early May, and as we 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.
spk14: 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.
spk27: Okay, great. Thank you.
spk43: Thank you. Our next question comes from Michael Schmidt with Guggenheim Partners. Your line is open.
spk16: Hey, guys. Good morning. Thanks for taking my questions, Andy. Congrats on this very impressive first quarter result. Thanks, Michael. What are you seeing? What are you seeing right now in terms of, you know, repeat customers, repeat patients, you know, versus new patients starting on therapy in the first quarter? And do you have an early read on duration, realizing that it's only been a few months at this point?
spk14: Yeah. So, obviously, we do see a significant percentage of repeat orders, you know, coming from the accounts. As I say, it's a little bit, you know, we just were, you know, four months in, and as I said, we've got, you know, 100 patients' worth of claims data. So, you know, what we can see are the accounts that are ordering have a very healthy percentage of, you know, 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.
spk16: Okay, and then just thinking about the trajectory over the rest of the year since, you know, 1Q was obviously above our expectation. And, you know, anything noteworthy as we, you know, head into early, you know, April, you know, data, you know, I think you mentioned through a prevalence versus incidence shift, perhaps, you know, anything, you know, noteworthy as it pertains to some of the size of the addressable population or any other market dynamics as we think about the trajectory of the rest of the year?
spk14: Yeah, so maybe a few high-level comments here. You know, as we see the data emerging and assess the performance, the execution here, the strength of the launch is really being driven by four factors. The first is unmet need. You know, it bears repeating that This is the first new drug specifically approved for platinum-resistant ovarian cancer in almost a decade. Seventy-five percent 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 Ella here, 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 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, you know, one of the questions going into this launch was how are you going to manage the baseline ocular Screening and happily to that preceded this 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 value partner to the ovarian cancer community. What that has translated into is strong demand for testing, broad and deep adoption. You've heard us talk about the uptake in the community and, in particular, patients with no prior experience with the drug. And in addition to that, we see rapid, you know, payer coverage. One important point to make is this is not inventory. So I just want to stress that we operate in a dropship 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 files there. So, as we look ahead, obviously, You know, 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, you know, we just have a lot to learn about this market, and we think that the pace of growth here Is it 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 as I say, the claims data that we have available is limited. Moving, you know, from the prevalent to the incident population. So, you know, this gets a little bit complicated, Michael, but, you know, when you look at ovarian cancer overall, The prevalence is over 230,000 women living with ovarian cancer in the U.S. 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 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 incidence we think is a better approach to modeling an advanced cancer population, particularly before Eli here with median overall survival of less than a year, it really doesn't account for launching into this prevalent population with limited treatment options. 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.
spk08: All right. Thanks a lot of detail, Mark.
spk43: Thank you. Our next question comes from Esther Dorout with BMO. Your line is open.
spk18: Great. Thanks for taking questions and congrats on a 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 realize it's early. Just wanted to kind of understand maybe some of the momentum exiting the first quarter and now exiting sort of the April month, and then I have a follow-up.
spk14: Yeah, 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 ton of this kind of conversation.
spk18: 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 of folate receptor alpha in newly diagnosed ovarian cancer patients. Just sort of curious sort of, you know, the testing and sort of how they may or may not sort of use those results.
spk09: Yeah, the testing up to this point has been very robust. As Mark mentioned, we've had over 5,400 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 a newly diagnosed ovarian patient. 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.
spk14: Maybe just describe a little bit what the results that a physician gets when they get the results back. That was your question, wasn't it, Esther, or?
spk18: Yeah, just one curious around sort of the, you know, testing of newly diagnosed patients versus sort of, you know, testing and kind of the platinum-resistant ovarian cancer population and sort of maybe the reasons or the dynamics why those physicians are running this.
spk14: Yeah.
spk18: Got it. Yeah, Anna?
spk37: Yeah, sure. Hi. So, you know, when physicians initially diagnose a 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, you know, from our perspective, that's really helpful so that, you know, for those patients who unfortunately do relapse, they'll know whether or not at some point Elihir will be a treatment option for them.
spk25: Got it. Thank you.
spk43: Thank you. Our next question comes from Andy Sy with William Blair. Your line is open.
spk20: Oh, great. Well, congratulations to everyone at Immunogen for this spectacular Eliher launch. I have two questions pertaining to the commercial launch. So, first is, Do you have a sense of the magnitude of ELA here penetration, both in the labeled population and also in the compendium listed population? Secondly, from a physician feedback perspective, just wanted to dig a little bit deeper into what is driving the uptake? Do they tell you about, you know, maybe longer, more deeper disease control, tolerability? And is there a difference within the academic or community settings?
spk09: Well, on the first question, you know, 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, you know, 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 that, Anne.
spk37: And then in terms of what's driving the uptake, 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 Elihir based on our clinical trial data. You know, patients with platinum-resistant ovarian cancer, their median overall survival is about a year, plus or minus a month or two. And with available therapies, single-agent chemotherapies give you a response rate, you know, 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, you know, 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 Elihir for high FRL subpatients, 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, you know, 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 Ella here. And it's a convenient once every three-week schedule as opposed to, you know, 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 this space for about 10 years. So, I think that's really what we're seeing. And, you know, if you engage with physicians who take care of these patients, that's what you'll get from them.
spk19: Great. Thank you.
spk20: And, say, Anna, can you, do you mind talking about the interim analysis for IMDC936, just in terms of what that entails? Thank you.
spk37: Yeah, sure, Andy. So, it's a standard Simon two-stage design. You know, 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.
spk28: Great. Thank you.
spk43: Thank you. Our next question comes from Boris Peeker with Cohen. Your line is open.
spk05: Great. Thank you. 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 Elihir versus others that are earlier on and are not immediately eligible for Elihir?
spk14: Yeah, 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 just prior to launch. You know, 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 ultramachine 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 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. You know, it's just a tricky. the tricky analysis to look at the folks that are ordering the tests versus the accounts that are ordering drug, you know, in an inability to match physicians and so on. So, we just don't have that visibility at this time.
spk05: 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, you know, what the dropout or discontinuation rate is or any other kind of observation about managing the side effects?
spk37: So, you know, we've done a really nice job building on what TIVDAC 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 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.
spk30: And, Boris, this is Mike. The only other thing I'd add at this point is in our post-marketing safety surveillance, we've seen nothing that is distinct at all from the clinical trial experience.
spk05: Great. Thank you very much for taking my question. Congratulations again.
spk43: Thank you. Thank you. Our next question comes from Peter Lawson with Barclays. Your line is open.
spk41: Great. Thanks so much. Off the mic congrats as well on the meaningful revenue. And just feeding off the last question, what's been the feedback from physicians around ocular toxicity?
spk37: 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, you know, we have patient-facing materials. We have materials for oncologists and for eye care professionals.
spk30: 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.
spk14: Yeah, I mean, just keep in mind that, Peter, we have on staff two ophthalmologists working here at Immunogen. And so, as Mike was alluding to, when we get notice 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. Perfect.
spk41: And then just if you can make any comments around the revenues performance, like a month-by-month in one queue, 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.
spk14: Yeah. So, we're going to stay away from monthly revenue. You will appreciate that it's growing and continues to grow. And then, sorry, Peter, your second question. What's that? Yeah. As I say, we've got less than 100 patients' worth of claims data at this point. And so, you know, I think it's hard to match that against the totality of 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, you know, sort of parsing the data in a way on a call like this.
spk41: 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're kind of reserving it as a very late line therapy, that would be great.
spk14: Yeah, I don't think they're approaching this as 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 the patient on drug irrespective of their irrespective of their line of therapy. And, you know, the NCCN guidelines were helpful in this regard in terms of not, you know, confining the recommended use of the drug by line of therapy. So that's, you know, militated in both directions in terms of later Lyme patients, but also earlier Lyme patients. Great. Thanks so much.
spk43: Thank you. Our next question comes from Kelly Shi with Jefferies. Your line is open.
spk42: Congrats on the stellar Q1. The volume in the community versus academic center was mentioned as stable at a 70 to 30 versus Q4. I'm curious if this 70 to 30 is also the split of patients seeking for treatment at a community center versus academic in real world. The second question is for the Item 9 ADC program, is the data updated in Q2-0 or remain on track? Thank you.
spk09: So, if I'm clear, the question's in relationship to the mix from community to academic? Okay. Yeah, so the-okay. You know, 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.
spk37: And then to your second question, Kelly, regarding IMGC 936. We will share data, you know, once we have passed the interim analysis, as I mentioned, from the first stage of the Simon 2 stage design. The exact timing of that is really going to depend on, you know, the enrollment and then the follow-up, too, so that we have a whole data set to share. Okay.
spk42: Thank you.
spk43: Thank you. And our next question comes from Asika Goonwarden with Truist. Your line is open.
spk15: Hi, good morning, guys. And I'm also going to offer my congratulations on a very well executed first quarter sales here for ELA here. So, Anna, we've spoken in the past a little bit about this, but I just wanted to check back with you and see that as you're getting more patients, what are you seeing in the, excuse me, I've got a frog in my throat here. What are you seeing in terms of the resistance mechanisms to ELA here that are emerging I understand it's early days, but we might be in a position to maybe give us more color on that. And then, also, on the commercial uptake side of the Elihir, just wondering if you can provide us any color on the uptake among medical oncologists versus Gynoncs. Thanks, guys.
spk37: Yeah. So, you know, we're certainly interested in mechanisms of resistance to Elihir. Elihir 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 a drug is no longer working for them, are a little less interested in subjecting themselves to a biopsy. So I think, you know, as we manage the life cycle of Eli here, we will continue to learn from a scientific perspective to, you know, better understand what mechanisms of resistance may occur. That being said, the duration of therapy that we are seeing is overall, and particularly in the patients with a confirmed response, really suggests a meaningful benefit to patients.
spk09: And if I, I'll jump in on the question specifically around the 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% of 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 MedOnc and Gynonc. The medical community really actually manages the disease over time. So we do see some 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.
spk26: Thank you.
spk43: Our next question comes from Joe Catanzaro with Piper Sandler. Your line is open.
spk31: 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, but 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.
spk14: Yeah. So, what we see, you know, on a daily basis is the orders that are coming in and we can assess that again, you know, so which of those are new accounts and which of those are repeat orders. It's not patient-level data, and obviously, you know, one of the points that we just want to make here is that, you know, our largest accounts are our academic accounts, and the uptake there has been very strong. And, you know, in terms of having those accounts come online, it's related to some of the points that Todd was making around, you know, their P&T committees and so on. But just to be clear, the uptake there, Is is ahead of our expectations and they are in fact, our largest, our largest customers, but it's hard in that context to tell whether. You've got a new patient from 1 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.
spk37: And switching back to your second question about IMGC936, the ADAM9 targeted ADC, You know, 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 2 stage design.
spk32: Okay. Got it. Thanks so much.
spk43: Thank you. And our last question comes from Jonathan Chang with SDB Securities. Your line is open.
spk21: Hi, guys. Thanks for taking our questions. This has to go 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?
spk07: Sure, Renee. Sure. We obviously are looking, as it relates to OPEX, We've seen with our here in support of the, of the growth trajectory and the success we are spending more than expected.
spk29: And we're reflected that in the guidance for the year.
spk22: Got it. Okay.
spk21: And then on the piccolo study, could you guys discuss what's the regulatory bar for indication expansion in that setting?
spk37: Yeah, so Piccolo is our monotherapy Mervituximab 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 settings. which has essentially artificially extended the 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. You know, 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, you know, very solid alignment with FDA on what that benchmark would be for us to proceed with a, you know, a single-arm study for accelerated approval. And I would say, you know, that is still evolving.
spk24: Got it. Thank you for taking our questions.
spk43: Thank you. We have a follow-up question from Peter Lawson with Barclays. Your line is open.
spk41: Great. Thank you so much. Thanks for the follow-up. I'm 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 spoke to the FDA about those studies.
spk37: 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, you know, discussed the design with FDA, and it's a randomized phase three 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-if conversations with FDA. And so, at this point, you know, our focus is on Mirasol data early May.
spk41: Gotcha. And so you'll be well positioned to start those conversations if needed with Gloriosa?
spk37: Yes.
spk40: Thanks so much. Thanks for the follow-up.
spk43: Thank you. There are no further questions. I'd like to turn the call back over to Mark Ennity for any closing remarks.
spk11: Great. Well, thank you all for joining us again today.
spk14: We are very pleased with the start we've made with Ella here and the 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.
spk43: Thank you for participating in today's program. This does include the program and you may now disconnect. Everyone, have a great day. Thank you. Thank you. Bye. Thank you. 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 Annabelle Chan, head of investor relations. Please go ahead.
spk06: 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 Ennedy, our President and CEO, Anna Birkenblit, our Chief Medical Officer, and Rene Lentini, our Interim CFO. Michael Vasconcellos, our EVP of Research, Development, and Medical Affairs, Isabella Colofonos, our Chief Commercial Officer, and Todd Tallarico, 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 risks outlined in our press release issued this morning, in the risk factor section of our most recent annual report on Form 10-K, And then our other FCC filings, which are available at scc.gov and immunogen.com. And with that, I'll turn the call over to Mark.
spk13: Thanks, Annabelle. 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 Elihir's commercial performance and on our ongoing development programs beyond Mirasol.
spk14: 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 Elihir, the advancement of our clinical programs for four novel ADCs, and the strengthening of our balance sheet by securing a non-diluted credit facility with Pharmacon for up to $175 million.
spk13: Before moving to our launch update, I first want to thank our commercial and medical teams for their outstanding work bringing Elihir to market.
spk14: In particular, I'd like to recognize Todd Tallarico, who has served as our interim chief commercial officer over the last five months for the exemplary performance leading the initial stages of the Elihir launch. Todd, thank you. I would also like to welcome Isabel Califanos, who joined us on Monday to drive the continued success of Elihir 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 worked to position Elihir 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 Elihear brings to an advanced ovarian cancer population with high unmet needs. 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 non-academic institutions and community-based oncology groups, and 80% of orders from new accounts came from those with no prior experience with Elihir. 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 FOLAR1 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 Eli here 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?
spk37: Thanks, Mark. We were pleased to present additional data from the SREA 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 anti-tumor activity of Mervituximab across different subgroups. We were also excited to receive resoundingly positive physician feedback on Elihir 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 Mervituximab development program, which has the potential to meaningfully expand the Elihir label. In January, we completed enrollment in PICOLO, our single-arm trial of Mervituximab 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 Mervituximab as the combination agent of choice in ovarian cancer, we are progressing two studies. The first is our phase three Gloriosa trial evaluating Mervetuximab 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 two study evaluating Merv plus carboplatin followed by Merv 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 PVEC in frontline BPDCM 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 BPDCM patients, And we also are continuing to enroll patients with a prior or concomitant hematologic malignancy to further explore the potential benefit of PVEC in this population. For our AML program, we progressed our 802 trial of PVEC 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 triplet 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 PVEX nagrolumab 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 two dose and 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 commit 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?
spk07: Thanks, Anna. For the first quarter of 2023, we generated $49.9 million in revenue, including $29.5 million in net product sales of Eliher, $15 million of license and milestone fees, and the remainder from non-cash 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 Pharmacon. Our financial guidance for 2023 has been updated, and we now expect revenues, excluding product revenue from Eliher, to be between $45 and $50 million. and operating expenses between $320 million and $335 million. We expect to provide Eliher 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 Eliher'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 Pharmacon, and combined with anticipated product and collaboration revenues, will fund operations into 2025. With that, we'll open the call for questions.
spk43: If you'd like to ask a question, please press star 1-1. If your question has been answered and you'd like to remove yourself from the queue, please press star 1-1 again. Our first question comes from John Newman with Canaccord Genuity. Your line is open.
spk17: Hi, guys. Good morning. Thank you for taking my question. I just had two quick questions. First one is regarding top line data for Mirasol. Should we still expect the focus to be on PFS with some discussion of immature overall survival data? Second question, I'm Ella here. You are only promoting for the labeled indications, but curious if you can talk at all about combination use with Avastin. Thank you.
spk37: Sure, John. So, we're on track for top-line data from Mirasol early May. And as we 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.
spk14: 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.
spk27: Okay, great. Thank you.
spk43: Thank you. Our next question comes from Michael Schmidt with Guggenheim Partners. Your line is open.
spk16: Hey, guys. Good morning. Thanks for taking my questions, Andy. Yeah, congrats on this very impressive first quarter result. Thanks, Michael. What are you seeing? What are you seeing right now in terms of, you know, repeat customers, repeat patients, you know, versus new patients starting on therapy in the first quarter? And do you have an early read on duration, realizing that it's only been a few months at this point?
spk14: Yeah, so obviously, we do see a significant percentage of repeat orders, you know, coming from the coming from the accounts. Again, As I say, it's a little bit, you know, we just were, you know, four months in, and as I said, we've got, you know, 100 patients' worth of claims data. So, you know, what we can see are the accounts that are ordering have a very healthy percentage of, you know, 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.
spk16: Okay, and then just thinking about the trajectory over the rest of the year since, you know, 1Q was obviously above our expectation. And, you know, anything noteworthy as we, you know, head into early, you know, April, you know, data, you know, I think you mentioned sort of a prevalence versus incidence shift perhaps, you know, anything, you know, noteworthy as it pertains to some of the size of the addressable population or any other market dynamics as we think about the trajectory of the rest of the year?
spk14: Yeah, so maybe a few high-level comments here. You know, as we see the data emerging and assess the performance, the execution here, the strength of the launch is really being driven by four factors. The first is unmet need. You know, it bears repeating that This is the first new drug specifically approved for platinum-resistant ovarian cancer in almost a decade. Seventy-five percent 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 Ella here, 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, you know, that we're bringing to the space. Equally important, this is a physician population that is acclimated to testing. So between bracket mutation testing and 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, you know, one of the questions going into this launch was how are you going to manage the baseline ocular screening, and happily, TIVDAC 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 bases for ocular exams, and so we've been able to ride on the back of that. 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 value partner to the ovarian cancer community and what that has translated into is 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 dropship 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 files there. So, as we look ahead, obviously, Um, you know, the revenue this quarter was 10 X what it was last quarter. Uh, and I think it's safe to say that, um, it will not continue to, um, scale linearly. Um, that said, you know, we just have a lot to learn about this market. Um, and we think that the pace of growth here. Is it going to be driven by a couple of key factors? The 1st 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 as I say, the claims data that we have available is limited. Moving, you know, from the prevalent to the incident population. So, you know, this gets a little bit complicated, Michael, but, you know, 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, you know, while using annual incidence we think is a better approach to modeling an advanced cancer population, particularly before Eli here with median overall survival of less than a year, it really doesn't account for launching into this prevalent population with limited treatment options. 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.
spk08: All right. Thanks a lot of detail, Mark.
spk43: Thank you. Our next question comes from Esther Dorout with BMO. Your line is open.
spk18: Great. Thanks for taking questions and congrats on a 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 realize it's early. Just wanted to kind of understand maybe some of the momentum exiting the first quarter and now exiting sort of the April month, and then I have a follow-up.
spk14: Yeah, 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, you know, a ton of this kind of conversation, so.
spk18: 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 of folate receptor alpha in newly diagnosed ovarian cancer patients. Just sort of curious sort of, you know, the testing and sort of how they may or may not sort of use those results. Okay.
spk09: Yeah, the testing up to this point has been very robust. As Mark mentioned, we've had over 5,400 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 a newly diagnosed ovarian patient. 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.
spk14: Maybe just describe a little bit what the results that a physician gets when they get the results back. That was your question, wasn't it, Esther, or?
spk18: Yeah, just one curious around sort of the, you know, testing of newly diagnosed patients versus sort of, you know, testing and kind of the platinum resistant ovarian cancer population and sort of maybe the reasons or the dynamics why those physicians are running this. Yes. Got it. Yeah.
spk37: Yeah, sure. That's a high. So, you know, when physicians initially diagnose a 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, you know, from our perspective, that's really helpful so that, you know, for those patients who unfortunately do relapse, they'll know whether or not at some point Elihir will be a treatment option for them.
spk25: Got it. Thank you.
spk43: Thank you. Our next question comes from Andy Sy with William Blair. Your line is open.
spk20: Oh, great. Well, congratulations to everyone at Immunogen for this spectacular Elihir launch. I have two questions pertaining to the commercial launch. So, first is, Do you have a sense of the magnitude of Elihir penetration, both in the labeled population and also in the compendium listed population? Secondly, from a physician feedback perspective, just wanted to dig a little bit deeper into what is driving the uptake? Do they tell you about, you know, maybe longer, more deeper disease control, tolerability? And is there a difference within the academic or community settings?
spk09: Well, on the first question, you know, 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, you know, 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 that, Anne.
spk37: 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 Eli here based on our clinical trial data. You know, patients with platinum-resistant ovarian cancer, their median overall survival is about a year, plus or minus a month or two. And with available therapies, single-agent chemotherapies give you a response rate, you know, 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, you know, by the time you have platinum-resistant disease, single-agent chemotherapies each have their own toxicity profile. And so based on that, they know that with Elihir 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, you know, 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 Ella here. And it's a convenient once every three-week schedule as opposed to, you know, 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 this space for about 10 years. So, I think that's really what we're seeing. And, you know, if you engage with physicians who take care of these patients, that's what you'll need from them.
spk19: Great. Thank you.
spk20: And so, Anna, can you, do you mind talking about the interim analysis for IMDC 936, just in terms of what that entails? Thank you.
spk37: Yeah, sure, Andy. So, it's a standard Simon two-stage design. You know, 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.
spk28: Great. Thank you.
spk43: Thank you. Our next question comes from Boris Peeker with Cohen. Your line is open.
spk05: Great. Thank you. And let me add my congratulations on excellent results. I guess at 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 Elihir versus others that are earlier on and are not immediately eligible for Elihir?
spk14: Yeah, so we do pay for A significant percentage of the test today, those that are performed at what we call the park 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 ultramachine 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 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. You know, it's just a tricky. the tricky analysis to look at the folks that are ordering the tests versus the accounts that are ordering drug, you know, and an inability to match physicians and so on. So, we just don't have that visibility at this time.
spk05: 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, you know, what the dropout or discontinuation rate is or any other kind of observation about managing the side effects?
spk37: So, you know, we've done a really nice job building on what TIPDAC 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, you know, 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 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.
spk30: And Boris, this is Mike. The only other thing I'd add at this point is in our post-marketing safety surveillance, we've seen nothing that is distinct at all from the clinical trial experience.
spk05: Great. Thank you very much for taking my question. Congratulations again.
spk43: Thank you. Thank you. Our next question comes from Peter Lawson with Barclays. Your line is open.
spk41: Great. Thanks so much. Offer my congrats as well on the meaningful revenue. And just the last question, what's been the feedback from physicians around ocular toxicity?
spk37: 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, you know, we have patient-facing materials. We have materials for oncologists and for eye care professionals.
spk30: 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.
spk14: Yeah, I mean, just keep in mind that we, Peter, we have on staff two ophthalmologists working here at Immunogen. And so, as Mike was alluding to, when we get notice 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. Perfect.
spk41: And then just if you can make any comments around the revenues performance, like a month-by-month in one queue, 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.
spk14: Yeah, so we're going to stay away from monthly revenue. You will appreciate that it's growing and continues to grow. And then, sorry, Peter, your second question. What's that? Yeah, as I say, we've got less than 100 patients' worth of claims data at this point. And so, you know, I think it's hard to match that against the totality of 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, you know, sort of parsing the data in a way on a call like this.
spk41: 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're kind of reserving it as a very late line therapy, that would be great.
spk14: Yeah, I don't think they're approaching this as 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 the patient on drug irrespective of their line of therapy. NCCN guidelines were helpful in this regard in terms of not, you know, confining the recommended use of the drug by line of therapy. So, that's, you know, militated in both directions in terms of later Lyme patients, but also earlier Lyme patients. Great. Thanks so much.
spk43: Thank you. Our next question comes from Kelly Shee with Jefferies. Your line is open.
spk42: Congrats on the Stella Q1. The volume in the community versus academic center was mentioned as stable at a 70 to 30 versus Q4. I'm curious if this 70 to 30 is also the split of patients seeking for treatment at a community center versus academic in real world. The second question is for the Item 9 ADC program. Is the data updated in Q2 still or remain on track? Thank you.
spk09: So, if I'm clear the questions in relationship to the mix from community to academic. Okay. Yeah, so the okay. You know, 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 start to carry higher volume across 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.
spk37: AND THEN TO YOUR SECOND QUESTION, KELLY, REGARDING IMGC 936, WE WILL SHARE DATA, YOU KNOW, ONCE WE HAVE PASSED THE INTERIM ANALYSIS, AS I MENTIONED, FROM THE FIRST STAGE OF THE SIMON II STAGE DESIGN. THE EXACT TIMING OF THAT IS REALLY GOING TO DEPEND ON, YOU KNOW, THE ENROLLMENT AND THEN THE FOLLOW-UP SO THAT WE HAVE A WHOLE DATA SET TO SHARE.
spk42: Okay, thank you.
spk43: Thank you. And our next question comes from Asika Gunwarden with Truist. Your line is open.
spk15: Hi, good morning, guys. And I'm also going to offer my congratulations on a very well-executed first quarter sales here for Ella here. So, Anna, we've spoken in the past a little bit about this, but I just wanted to check back with you and see that as you're getting more patients, What are you seeing in the – excuse me, I've got a frog in my throat here. What are you seeing in terms of the resistance mechanisms to Elihir that are emerging? I understand it's early days, but we might be in a position to maybe give us more color on that. And then also on the commercial uptake side of the Elihir, just wondering if you can provide us any color on the uptake among medical oncologists versus Gynoncs. Thanks, guys.
spk37: Yeah, so, you know, we're certainly interested in mechanisms of resistance to Elihir. Elihir 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 downregulation 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 a drug is no longer working for them, are a little less interested in subjecting themselves to a biopsy. So I think, you know, as we manage the life cycle of Elahir, we will continue to learn from a scientific perspective to, you know, 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.
spk09: And I'll jump in on the question specifically around the 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 MedOnc and Gynonc. The medical community really actually manages the disease over time, so we do see some 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.
spk43: Thank you. Our next question comes from Joe Catanzaro with Piper Sandler. Your line is open.
spk31: 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, but 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.
spk14: Yeah. So, what we see, you know, on a daily basis is the orders that are coming in and we can assess that again, you know, so which of those are new accounts and which of those are repeat orders. It's not patient level data, and obviously, you know, one of the points that we just want to make here is that, you know, our largest accounts are our academic accounts and the uptake there has been has been very strong. And, you know, in terms of having those accounts come online, it's related to some of the points that Todd was making around, you know, their P&T committees and so on. But just to be clear, the uptake there. Is is ahead of our expectations and they are in fact, our largest, our largest customers, but it's hard in that context to tell whether. You've got a new patient from 1 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.
spk37: And switching back to your second question about IMGC936, the ADAM9 targeted ADC, You know, 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 2 stage design.
spk32: Okay. Got it. Thanks so much.
spk43: Thank you. And our last question comes from Jonathan Chang with SDB Securities. Your line is open.
spk21: Hi, guys. Thanks for taking our questions. This has to go on for Jonathan, and congrats on the progress this quarter. I 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? Sure, Renee.
spk07: Sure. We obviously are looking, as it relates to OPEX, We've seen with our here in support of the, of the growth trajectory and the success we are spending more than expected.
spk29: And we're reflected that in the guidance for the year.
spk22: Got it. Okay.
spk21: And then on the piccolo study, could you guys discuss what's the regulatory bar for indication expansion in that setting?
spk37: Yeah, so PICOLO is our monotherapy Mervituximab 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 settings. which has essentially artificially extended the 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. You know, 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.
spk24: Got it. Thank you for taking our questions.
spk43: Thank you. We have a follow-up question from Peter Lawson with Barclays. Your line is open.
spk41: Great. Thank you so much. Thanks for the follow-up. I'm 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 spoke to the FDA about those studies.
spk37: 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, you know, discussed the design with FDA, and it's a randomized phase three 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-if conversations with FDA. And so, at this point, you know, our focus is on Mirasol data early May.
spk41: Gotcha. And so you'll be well-positioned to start those conversations if needed with Gloriosa?
spk37: Yes.
spk40: Thanks so much. Thanks for the follow-up.
spk43: Thank you. There are no further questions. I'd like to turn the call back over to Mark Ennedy for any closing remarks.
spk11: Great. Well, thank you all for joining us again today.
spk14: We are very pleased with the start we've made with Ella here and the 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 Mirastol study. Thanks.
spk43: Thank you for participating in today's program. This does include the program and you may now disconnect. Everyone, have a great day.
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