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spk08: Good morning and welcome to Immunogen's third quarter 2022 financial and operating results conference call. Today's conference is being recorded. At this time, I'd like to turn the call over to Annabelle Chen, head of investor relations. Please go ahead.
spk11: 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 in third quarter 2022 financial results. This press release, a recording of this call, and an updated corporate deck can be found under the investors and media section of our website at immunogen.com. With me today are Mark Ennedy, our president and CEO, Anna Birkenblatt, our chief medical officer, and Susan Altshuler, CFO. During today's call, we will review recent accomplishments for the business, our Q3 financial results and highlight upcoming anticipated events. We will be making forward-looking statements based on our current expectations and beliefs. These statements are subject to risks and uncertainties, and our actual results may differ materially. Please consult the risks outlined in our press release issued this morning, in the risk factors section of our most recent annual report on Form 10-K and quarterly report on Form 10-Q, and in our other SEC filings, which are available at sec.gov and immunogen.com. With that, I'll turn the call over to Mark.
spk15: Good morning, and thank you for joining us today. With approval expected on or before our November 28th PDUFA date, we've taken the last quarter to complete our preparations to launch Mervituximab this month. Just to put a finer point on these activities, our highly experienced field team is fully staffed and out engaging with customers, Our distribution, market access, and patient support infrastructure is in place, and we have vials of commercial-ready drug product and inventory awaiting labeling and packaging. With this strong foundation in place, we are ready to rapidly deliver Merv to patients upon approval. As part of our preparations, we have recently updated our ovarian cancer market model, which draws on data from a couple of external sources. First, this market is highly concentrated with roughly 4,300 physicians treating just over 80% of ovarian cancer patients in the United States. At launch, we will be taking a targeted approach to drive adoption by focusing as an initial priority on a subset of 400 physicians that treat roughly one-third of patients. Looking to the market opportunity, our estimate of the eligible patient population is based on data from DRG, which indicate that there are 19,500 drug-treatable second through fourth line platinum-resistant ovarian cancer patients in the US each year. Roughly 35 to 40% of these patients express high levels of FR-alpha, and 75% currently receive single-agent chemotherapy or non-vebacizumab regimens. This gives us a market opportunity of roughly 5,200 patients for our anticipated initial label. We will also seek NCCN compendium listing for the MERV BEV combination immediately after approval, which would add another 1,800 FR-alpha high patients, giving us a total market opportunity of 7,000 patients in the platinum-resistant setting. As we will discuss later in the call, we have also initiated studies to move into recurrent platinum-sensitive disease which would bring the total U.S. market opportunity for MIRV and recurrent ovarian cancer to above 11,000 patients. We've included an updated market slide as part of our corporate deck posted on our website today. On the topic of ongoing development, we expect to report top line data from the confirmatory MIRASOL trial early next year and look forward to sharing those data as we pursue full approval in the U.S. and initial regulatory filings in the EU. We are also advancing our efforts to move Merv into platinum-sensitive populations and have activated the first sites in both the Gloriosa and Trial420 studies to address these patients. Moving to our PVEC program, in August, we shared an important update on our pivotal Cadenza study in frontline BPDCN, and we'll provide more detail on this study, but in short, Following initial analysis showing significant activity in patients with de novo disease and those who presented with a prior or concomitant hematologic malignancy, we aligned with FDA that the efficacy of valuable population will be in de novo patients. As a result, we now expect to report top line data in 2024. Also of note, we will be presenting initial data from our PVEC triplet expansion cohort in AML at ASH in December. This will be the fourth consecutive oral presentation for PVEC at ASH. Anna will cover both the MERV and PVEC programs in just a moment. Looking at the rest of the pipeline, we anticipate sharing initial data before year end from the phase 1 dose escalation of IMGC936, our first-in-class ADAM9 targeting ADC and co-development with macrogenics. We've also made meaningful progress on our phase 1 study of IMGN151 and expect to put the first patient on study before the end of the year. With that, I'll turn the call over to Anna to provide additional color on our development programs. Anna?
spk13: Thanks, Mark. As noted, with MIRV's upcoming PDUFA date, we are confident that we will be granted accelerated approval on or before November 28th. Given the totality of the data generated, and in particular, the strength of the pivotal SREA data, we believe MIRV has the potential to displace single-agent chemotherapy as a new standard of care for patients with folate receptor alpha-positive platinum-resistant ovarian cancer. Beyond the initial label, the broader MERV program continues to advance as we work toward full FDA approval for MERV in the U.S., generate data in earlier lines of treatment, and position MERV as the combination agent of choice in ovarian cancer. Reflecting these efforts, we presented additional data, including patient-reported outcomes from FORWARD-1 and population pharmacokinetic and exposure response analyses of MIRV monotherapy from Sirea, FORWARD-1, and our Phase 1 trial at ESMO in September. Last week at ESGO, we presented additional data from these studies characterizing the extended treatment benefit for patients with recurrent ovarian cancer. Building upon these monotherapy studies, we are continuing to enroll patients in PICOLO, our single-arm study in folate receptor alpha-high recurrent platinum-sensitive ovarian cancer, which may support label expansion in 2024. Turning to our ongoing combination studies, at IGCS, we presented encouraging data for both the mervituximab plus bevacizumab and the Mervituximab plus carboplatin doublets in folate receptor alpha positive ovarian cancer. Notably, the Mervituximab plus Bevacizumab combination demonstrated significant activity across a broad range of folate receptor alpha expression levels in patients that were Bev-naive or Bev pretreated and regardless of platinum-free interval. We look forward to advancing this regimen in the platinum-sensitive maintenance setting in the randomized Phase III Gloriosa study, which was recently initiated. We are pleased with the recent progress of our second pivotal program, Pivecamab, or PVEC. In an initial analysis of data from our ongoing Phase II CADENZA trial in frontline BPDCN patients, we were very encouraged with the activity seen in both de novo patients and BPDCN patients with a prior or concomitant hematologic malignancy. with 11 of 13 or roughly 85% of patients achieving a form of complete response. In discussion with FDA, we aligned that the primary efficacy of valuable population will be in the de novo BPD-CN patients with CR-CRC as the primary endpoint and duration of CR-CRC as the key secondary endpoint for the study. In addition, FDA encouraged us to generate data to support assessing CRH as an endpoint. Accordingly, we will also continue to enroll BPDCN patients with PCHM in Cadenza to further explore the potential benefit of PVEC in this population. Turning to our PVEC triplet with azacitidine and venetoclax in AML, The data presented at SOHO in September demonstrated broad activity in adverse genetic subsets of relapsed refractory disease. And at ASH in December, we will present initial data from the relapsed and frontline unfit AML expansion cohort in an oral session. And with that, I'll turn the call over to Susan to cover our financials.
spk12: Susan? Thanks, Anna. For the third quarter of 2022, we generated $15.4 million in revenue, $8 million of which came from non-cash royalty revenues and the remainder from license and milestone fees. Operating expenses were $92.8 million, comprised of $59.2 million of R&D expenses, $33.6 million of selling general and administrative expenses, and we ended the third quarter with $309.5 million in cash on the balance sheet. Our financial guidance for 2022 has been updated. and we now expect revenues to be between $80 and $90 million, operating expenses between $320 and $330 million, and cash and cash equivalents at year end between $230 and $240 million. Revenue guidance does not reflect any potential MRF product sales. The increase in operating expense guidance is largely attributable to faster than expected hiring, preparation for commercialization, and strong clinical trial startup and execution. We anticipate operating expenses to grow in the fourth quarter, but at a moderated pace relative to that seen in the third quarter. We expect that our current cash, combined with anticipated product and collaboration revenues, will fund operations into 2024. With that, we'll open the call for questions.
spk08: Thank you. As a reminder, to ask a question, you'll need to press star 1-1 on your telephone.
spk06: Please stand by while we compile the Q&A roster. Our first question comes from John Newman with Canaccord Genuity.
spk08: Your line is open.
spk17: Hi there, team. Good morning. Thank you for taking my question. Just curious... Regarding the top-line data for Mirasol in early 2023, I'm just curious if you think, in addition to the PFS endpoint, that you might be able to talk a bit about some of the secondary endpoints, including overall survival, but also the patient-reported outcomes tool that you are using. Thanks.
spk13: Sure. Hi, John. So, at the time we have top-line data early in 2023, we will report on the primary endpoint for Mirasol, which is progression-free survival. And at that point, we will have interim data or immature data on overall survival. That's one of the key secondary endpoints. We'll also have information on ORR and DOR. I think that's a little too early to anticipate having PRO data, patient-reported outcomes data, It takes a bit more time to analyze, and that will be coming sort of in the second wave of data. And we look forward to sharing top line data as early as possible in detail at a major medical meeting. And I would anticipate that patient reported outcomes would be reported subsequently.
spk06: Great. Thank you. Thank you. One moment. We have a question from Michael Schmidt with Guggenheim Partners.
spk08: Your line is open.
spk04: Hey, guys. Good morning. Thanks for taking my question. It sounds like, Mark, that you sort of increased your patient assumptions slightly, if I'm not mistaken, from your prior estimates for the initial target opportunity. Could you talk about how you think about the initial launch trajectory may play out. Just wondering, you know, with the testing dynamics, you know, how you're thinking about, you know, adoption of the test, perhaps relative to other tests like the, you know, the BRCA test that is used widely in ovarian cancer. And any thoughts you could share on sort of on that topic? Thank you so much.
spk15: Sure, so maybe just starting with the numbers. So, in conjunction with our launch preparations generating an internal forecast, we went out to our principal vendors, which include DRG, IQIA, and Kantar Health to get updated epi data and then also better understand the distribution between single-agent chemotherapy or, you know, combinations that don't use Bevacizumab and then the segments of the population that are Bevcombo treated. And, you know, the net effect of that was the overall numbers, particularly in our initial indication of, you know, second through fourth line platinum-resistant ovarian cancer patients increased Also, what we saw was a slight elevation in terms of the use of single-agent chemotherapy and these non-BEV regimens in that population. And those are the principal things that drove the numbers up from our prior forecast or prior data that we shared in terms of the market opportunity. And then, sort of turning to launch and adoption, so, you know, Obviously, the first step here is to identify the patient's FR alpha status. And so, you know, testing is the important first step in that. We've been working with Roche. We have four TARP labs that are up and running and ready to accept samples. upon approval, so these are centralized labs to which archival tissue or even fresh biopsies, although those tend to be rare, are sent, and then the patient's FR-alpha status is determined and transmitted back to the treating physician. Right now, we estimate that that's a three- to five-day turnaround. We've talked about, you know, from the time a patient comes in, to the time they're actually dosed is probably going to be a couple weeks, you know, allowing for both the turnaround time for the test and then also scheduling for an infusion. So, you know, look, we have physicians telling us now or asking us now, you know, where can they send their samples? You know, we've seen awareness. of FR-alpha increased significantly over the last year. You know, we are out at all of the major congresses with additional MERV data, either monotherapy or in combination. And so, awareness of the product is rising commensurately with interest in the target. So, you know, we feel very good about where we are. in terms of the launch. We've got the folks in the field right now profiling the accounts so that they can understand, you know, things like ordering sets and the like. So I think we're in very good shape and, you know, are excited about the prospects. I think we're a ways away from actually offering you any specific product revenue guidance given the early stages of where we are today.
spk04: Great.
spk06: Thank you so much, Mark. Thank you. And our next question comes from Etzer Derout with BMO.
spk08: Your line is open.
spk03: Great. Thanks for taking the questions. Just wondered, Mark, if you had any, you know, labeling negotiation discussions with the FDA for MIRV accelerated approval, and maybe just sort of generally where you are in sort of your current conversations with them. And then secondly, just quickly, if you could just remind us for IMG and 151, looks like phase one was initiated. If you could just sort of remind us where or how you plan to position this asset relative to MIRV rituximab. Thanks.
spk15: Sure. In terms of FDA, we've been, you know, actively engaged with the agency. You know, the form and substance of those conversations have been both positive and productive, and we are highly confident in an approval on or before the PDUFA date. Beyond that, we really can't comment other than to say, as I just said to Michael, we're ready to launch the product this month. You know in terms of 151 so you know you'll remember. This is a molecule on that's been designed specifically with improvements and to the antibody the linker and the payload all of which are Driving towards activity at lower levels of fr alpha expression so you know the initial positioning here is really twofold one to get at the market segments and where, you know, MERV has been less active, certainly as a monotherapy. Those are patients with medium and low levels of expression where, you know, we see certainly in the preclinical setting, you know, significant activity with 151. And then in addition to that, moving outside of ovarian cancer where the indications like triple negative breast cancer are characterized generally with lower levels of FR alpha expression. And so that's how we're thinking about it. We've initiated our first site with the 151 and expect to put our first patient on before the end of the year.
spk07: Great. Thank you.
spk06: Our next question is coming from Boris Peeker with Cowan.
spk08: Your line is open.
spk14: Great. My first question is on the Gloriosis study. Can you comment on your discussion with the FDA of that study potentially being confirmatory trial in case if Mirasol does not reach its statistical endpoints?
spk13: Hi, Boris. So we aligned with FDA on the design of Gloriosa, which is a randomized phase three study of Merv plus Bev in the maintenance setting in recurrent platinum sensitive disease compared with Bevacizumab alone. We're really excited about that study. It's initiated and we're getting going here. When we aligned with FDA on the design of that study, we did not specifically address the potential for it to be a confirmatory study. However, you know, stepping back, certainly it's appropriate to think that, you know, on the off chance that Mirasol does not turn out the way we expect it to, Gloriosa absolutely could serve as a confirmatory study if needed.
spk14: Great. And maybe in terms of your labeling discussion, what are your kind of thoughts on Avastin pretreatment requirements being in the label or potentially black box warning label provision talks? Is that part of the discussion? Kind of what have you asked the FDA and what have the comments been around that?
spk13: So, as Mark mentioned, we've had productive and collaborative discussions with FDA during label negotiations, and we look forward to sharing the details of the final label. And what I can tell you at this point is that we're pleased with the tone and tenor of the conversations.
spk07: Great. Thanks very much for taking my questions.
spk06: Our next question comes from Andy Hsai with William Blair.
spk08: Your line is open.
spk02: Great. Good morning, and thanks for taking our questions. Maybe one just kind of similar to what Boris asked previously, but, you know, with focus on the commercial team. So, obviously, going in, there's, you know, if we assume approval, there's two outcomes. Maybe the label that's more aligned with SREA label that's more aligned with Marisol. So I'm just curious, these two populations, the Avastin experienced or Avastin agnostic populations, how much of a difference in terms of messaging would the commercial team be responsible to communicate, you know, as we kind of head into the PDUPA date?
spk15: So, the commercial team is not out talking about the product right now. So, they are in the accounts understanding ordering patterns, patient flow, that kind of thing. But there's no discussion of the drug at this point. As part of the profile, you could imagine them talking, asking about, you know, patient flow, use of prior Avastin, that sort of thing. But again, there's no discussion of the drug per se. You know, based on our prior experience, we think, you know, roughly half of the second to fourth line platinum resistant population will be Bev-naive is what we call it, and then the other half will have had prior BEV, and that's just based on the outputs that we had from forward one in this setting. So, does that answer your question, Andy?
spk02: Yeah, yeah, yeah, exactly. Great. And then I have a follow-up on PVEC. So, yesterday, obviously, the flipped ITD data is very provocative, and, you know, I think that's becoming kind of a standard mutation to look for within the panel of molecular markers. I don't know if you have a view of whether it's a worthwhile exercise to talk to the FDA about a potential expedited pathway, just given the history within that sub-market in AML. And if so, I'm curious if you can let us know if that discussion has taken place or it's planning in the future. Thanks.
spk13: Thanks, Andy. So we really look forward to our oral presentation for our triplet data of PVEC plus venetoclax and azacitidine at ASH. And what you're referring to is in our abstract, we had 71 patients with relapsed refractory AML, where we see very encouraging data for the triplet overall, and particularly in certain subsets, including VEM-naive patients as well as patients with a FLT3 ITD. As you know, there are FLIP3 inhibitors that are approved, and patients with AML with FLIP3 mutations also do quite well with Veneza. And so I think it's certainly fair to say that our investigators are very excited with the activity that we're seeing, specifically, you know, the overall response rate we're seeing of 82% and the CR rate of 64%. And I certainly think that's one option that's on the table for, you know, considering for further development if we choose a very niche strategy.
spk06: Thank you.
spk08: Our next question will come from Courtney Kowalski with Barclays. Your line is open.
spk09: Hey, thank you. This is Peter Livingston in for Courtney. Just on the expected turnaround and testing for FR Alpha, just if you can kind of give us an idea of turnaround time, how many labs have kind of signed up for the test and potentially trained for the test, and kind of how you see that increasing over time.
spk15: Sure. So our expectation right now is three to five days in terms of the turnaround. Right now, there are four labs that have been certified. We call them TARP labs. So we work with Ventana to validate those labs so they're ready to receive samples. We do expect over time. So this test is run on a Ventana, a machine called a Benchmark Ultra, which is installed in the vast majority of, you know, large institutions. So, we do expect over time that those institutions will be trained on the test and then start running the test in-house as opposed to sending the samples out to the centralized labs.
spk07: Gotcha. Thank you.
spk09: And then just how do you, do you need more labs signed up? Just what's your, your reach with the existing four labs?
spk15: The existing four labs will, you know, cover the entire country and have, you know, significant capacity. Just, you know, if you think about this patient population, they could run all 5,200 patients every year in terms of their capacity. So capacity is not a constraint here. It's just the logistics of, you know, accessing samples and getting them to the laboratories.
spk09: Gotcha. Thank you. And then I know we've spoken about this before, but just the The departure of your CCO, just if you talk through the depth of the team, finding a replacement, if that causes any kind of uncertainty amid a potential launch.
spk15: Sure. So, you know, obviously the timing here is unfortunate, and I guess we'd make three points here. The first is that this was a personal decision that was going to allow Kristen to be closer to her home. The second is, you know, this is unrelated to the business. We are highly confident in an approval on or before the PDUFA date. And lastly, you know, and importantly, and we thank her for this, she's leaving us in great shape. So, we have recruited a deep bench. We're pleased to have Tom Tallarico step into the interim role. This is someone with more than 30 years of experience in the industry. He's carried a bag. He's worked in marketing. He's just a consummate market access professional. So he's got a breadth and depth of experience that covers all the critical commercial functions. And he stepped into the role and the team is very happy with him. You know, beyond that, when we look at the field force, you know, starting at the top with Nicole Crawford, again, this is somebody with, you know, 20-plus years of experience in the industry, selling, you know, and her last role, radio pharmaceutical. So, you know, familiar with, you know, a product construct like an ADC. you know, deep experience in solid tumors and heme malignancies, strong marketing. So we, you know, we've got a breadth and depth when we look at the diversity of the field force we've drawn from, you know, many of the, you know, the premier oncology franchises around the industry. So this is a very experienced team and, you know, not rattled by, you know, this kind of thing, you know, ready to go. And, you know, I think Part of this is driven by the enthusiasm that we're seeing from our customer base, right? And so when you know you've got a product that people want, you're energized. And, you know, when you walk around the halls of Immunogen and, you know, I went to a sales training meeting in Tampa two weeks ago, you know, people are psyched. And so I think this is, you know, it's an exciting moment. As I said, the timing with respect to Kristen is unfortunate, but we're ready.
spk07: Great. Thanks, Mike.
spk06: We have a question from Kelly Shee from Jefferies.
spk08: Your line is open.
spk01: Thank you for taking my questions. First of all, I am not EDC. What kind of value would you choose to present as a first in human data? And also, would the data be informative enough to guide what solid tumor types you could pursue in the next stage? And secondly, during the launch preparation, I'm wondering, have you heard any logistic challenges to coordinate with ophthalmologists to manage ocular tox? Thank you.
spk13: Yeah, so IMGC936 is our ADAM9-targeted ADC that we are in co-development with with Macrogenics. And we look forward to sharing data from our Phase I First in Human Dose Escalation Study before the end of the year. I think those data will help folks understand, you know, the thoughts for further development there in terms of tumor type, dose, and schedule. So, we look forward to sharing that before the end of the year.
spk15: Yeah, and in terms of, you know, ophthalmologist consults. You know, we're fortunate to, you know, have worked with a number of centers already in conjunction with our clinical trials. So, you know, we've got those relationships that exist in many of our target centers. Beyond that, we're not the first ADC to come with ocular events. And so, again, you know, as we are profiling accounts, you know, one of the key questions being asked is, you know, how are you doctors set up in terms of a referral with respect to eye exams in conjunction with the administration of therapy. And what we're finding is that those relationships are up and running. And then we've also put together, you know, standard messaging to help in the event that those relationships don't exist, that they can get set up to support managing the ocular events that may arise in conjunction with therapy.
spk12: And one thing I would just add is that it's not just ophthalmologists, but eye exams can be done by optometrists, which is helpful in the community setting.
spk06: Thanks. Thank you. One moment. We have a question from Arthur He with HC Wainwright.
spk08: Your line is open.
spk16: Hey, good morning, everyone. This is Arthur on 4RK. Most of my questions have been asked, and I just had one on the 151. Could you remind us of what's the inclusion threshold for the FR alpha expression for the Phase 1 study? And based on that, how large of the address for patient population compared to the MERV?
spk13: Thank you. Yeah, sure. So, is expressed in 80, 85% of ovarian cancers. So that's like, almost all ovarian cancers. And so in our 151, 1st in human study, we are enrolling all ovarian cancer patients and we're collecting tumor tissue on everyone. So this really does have the potential to impact and improve the lives of all ovarian cancer patients, not just those with high expression. With endometrial cancer, that is the other type, particularly the high-grade serous subset that has FR-alpha expression, and again, at lower levels than for MERV, but is also really an exciting tumor type for us to be exploring for 151 in our Phase I study.
spk07: Thank you. Thank you for taking my question, and congrats on the progress.
spk05: Thank you. Thank you.
spk06: Our next question comes from Daniel Wolley with JP Morgan.
spk08: Your line is open.
spk10: Daniel Wolley Good morning, everyone. Thanks for taking our question. Anna, previously you had mentioned a CR-CRI rate of about 40% as exciting in the relapsed refractory setting of AML. With the abstracts for ASH showing a composite complete remission of 31% for the PVEC triplet, how should we think about the data that's going to be presented at ASH?
spk13: Yeah, so, you know, triplet development in relapsed refractory AML is really interesting because we need to really understand who our patients are. And it's clear that the evolution of the treatment paradigm is ongoing and unfolding as Veneza is increasingly becoming the standard of care in the frontline setting. So understanding the benchmark in the relapsed AML setting is I would say an area of intense scrutiny for us at this very time so that we can understand who the patients are who benefit most from our triplet. I'd point out that we have a robust data set at ASH of 71 patients in our abstract, and you should expect to see even more patients in the oral presentation. as well as details on who these patients are that will guide further therapy. That 40%, you know, finger in the wind is really, you know, good enough for initial thinking, but not good enough for us to say, okay, what is really the bar in this patient population where we see the most activity? So that's where we're focusing our work internally as well as getting feedback from external advisors. So stay tuned for ASHE.
spk10: Great, very helpful.
spk05: Thank you very much.
spk08: Thank you. And our last question comes from Jonathan Chang with SVB Securities. Your line is open.
spk00: Hi, guys. This is Faisal Khashid. I'm for Jonathan. I just wanted to ask about the PVEC data coming up. I wanted to confirm the abstract looked like it was just relapsed refractory. You'll be presenting frontline data as well? And I also want to ask what you see as the path forward for PVEC in AML.
spk13: Thanks for the question. We do anticipate having, we will have frontline data at the oral presentation. We didn't quite have enough for inclusion in the abstract given the early cutoff date that was required for abstract submission. So, yes, you should anticipate seeing not just more relapsed refractory patient data than is in the abstract, but you should also anticipate seeing I would say a small but meaningful group of frontline AML patients who have received our triplet. I would also point out that as we have been developing the triplet, knowing that others have stumbled in terms of toxicity when adding a third agent to an already myelosuppressive van aza regimen, we have proceeded, I would say, not with caution but with prudence, really exploring a 14-day regimen of venetoclax And so, the data that we've gathered in the frontline setting now is really allowing us to explore further activity of the triplet, increasing the duration of then dosing up to the labeled 28 days, which would guide further development and is important as we think about the registration strategy.
spk07: Got it. Thanks for taking our questions.
spk08: Thank you. And there are no other questions in the queue. I'd like to turn the call back to management for any closing remarks.
spk15: Great. Thank you. Look, this is an exciting moment for us. We've made tremendous progress over the course of this year, and we are very much looking forward to reconnecting with all of you within the month to talk about an approval for Mervituximab. Thanks, and have a great weekend.
spk08: This concludes today's conference call. Thank you for participating. You may now disconnect.
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