ImmunoGen Inc (IMGN) 2022 Q2 法說會逐字稿

Good morning, and welcome to ImmunoGen's Second 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 Anabel Chan, Head of Investor Relations. Please go ahead.

Good morning, and thank you for joining today's call.

Earlier today, we issued a press release that includes a summary of our recent operating progress and second quarter 2022 financial results. This press release and a recording of this call can be found under the Investors & Media section of our website at immunogen.com. With me today are Mark Enyedy, our President and CEO; Anna Berkenblit, our Chief Medical Officer; Kristen Harrington-Smith, our Chief Commercial Officer; and Susan Altschuller, our CFO.

During today's call, we will review recent accomplishments for the business, our Q2 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.

And with that, I'll turn the call over to Mark.

Good morning, and thank you for joining us today. This past quarter, we made significant progress across the business, and importantly, FDA accepted the BLA for mirv with a priority review designation and set a PDUFA date of November 28. Our ongoing interactions with the FDA have been productive, and in conjunction with our midcycle review, we were advised that the agency has no plans for an advisory committee at this time.

As we transition into a global, fully integrated oncology company, we are actively preparing for the potential launch of mirv monotherapy for patients with folate receptor alpha positive ovarian cancer. Kristen will provide an update on our launch readiness progress later in the call.

In terms of ongoing development, we're pleased to report that our confirmatory Phase III MIRASOL trial is now fully enrolled, and we expect to share topline results from the study in early 2023. We are also advancing our efforts to move mirv into broader patient populations. To that end, we are expanding our development program and are in the process of initiating the GLORIOSA and Trial 0420 studies.

Moving to our second pivotal program, pivek, we are pursuing cohorts in BPDCN and AML and anticipate reporting important data in both of these indications later this year. Anna will cover both the mirv and pivek programs in more detail.

Lastly, with the progress in our pivotal programs, we are reinvesting in our research capabilities and deepening our earlier stage pipeline, as exemplified by our recent research collaboration with Oxford BioTherapeutics to develop novel ADCs. We look forward to deploying our proprietary linker-payload technology against the targets identified by OBT to address cancers of high unmet need.

So with an exciting first half of the year and a number of important milestones ahead, we believe we are well positioned to create meaningful value for our patients and our shareholders in both the short and long term. With that, I'll turn the call over to Anna to provide additional color on our clinical programs. Anna?

Thanks, Mark. At ASCO, we were excited to present additional efficacy data from the pivotal SORAYA study and an integrated safety summary of single-agent mirv across multiple studies. The SORAYA update included tumor reduction in over 70% of patients and a disease control rate of over 50% in a heavily pretreated population. Preliminary median overall survival was 13.8 months. And the Kaplan-Meier curve for PFS shows a long tail, consistent with a significant portion of patients having prolonged benefits of mirv. The retrospective pooled analysis of SORAYA, FORWARD I and our Phase I study demonstrated a remarkably consistent tolerability profile with differentiated safety, consisting primarily of low-grade, reversible gastrointestinal and ocular events.

Treatment options remain limited for patients with platinum-resistant ovarian cancer, particularly for those who have received prior bevacizumab, and are associated with low response rates, short durations of response and considerable toxicities. Against this background of high unmet need, we believe the benefit demonstrated in SORAYA further supports mirv's potential to become a new standard of care in this population.

As Mark mentioned, we have fully enrolled our confirmatory MIRASOL study and anticipate topline data early next year. We also advanced patient enrollment in PICCOLO, our single-arm study of mirv monotherapy in recurrent platinum-sensitive ovarian cancer patients with high expression of folate receptor alpha, intended to support label expansion. As we look to position mirv as the combination agent of choice in ovarian cancer and expand its reach, we are in the process of initiating our Phase III GLORIOSA study, which will evaluate the benefit of mirv plus bevacizumab maintenance versus bevacizumab maintenance alone in the second-line platinum-sensitive setting. And Trial 0420, which is intended to inform a potential path to registration in recurrent platinum-sensitive ovarian cancer. Trial 0420 is a single-arm Phase II study of mirv plus carboplatin, followed by mirv continuation in approximately 110 platinum-sensitive ovarian cancer patients with low, medium or high expression of folate receptor alpha. Looking ahead, we're excited to present additional data from our mirv program at ESMO and IGCS, both in September.

We also anticipate preliminary efficacy data from our pivotal CADENZA study of pivekimab in frontline BPDCN by the end of this year. In addition, patient enrollment is advancing in our expansion cohort of a Phase Ib/II study evaluating pivek, azacitidine and venetoclax in relapsed and frontline AML patients. And we expect to share initial data from this study at ASH in December.

Regarding our earlier stage pipeline, we anticipate sharing initial data before year end from the Phase I dose escalation trial of IMGC936, our first-in-class ADAM9-targeting ADC in co-development with MacroGenics. We also made meaningful progress addressing the CMC information request from FDA regarding our Phase I study of IMGN151 in multiple solid tumor types and expect to enroll our first patients this fall.

With that, I'll turn the call over to Kristen to touch on our commercial preparations. Kristen?

Thanks, Anna.

We were pleased with FDA's acceptance of our BLA with priority review. And in anticipation of a potential approval later this year, we are advancing the buildout of our medical and commercial infrastructure. To that end, we are focused on 4 key imperatives to ensure a successful launch. These are: with the compelling data from SORAYA, redefining expectations for positive outcomes with mirv in platinum-resistant ovarian cancer; supporting adoption of early folate receptor alpha testing and establishing standards for in-house and centralized testing upon approval; seeking broad payer access and reimbursement to deliver a seamless patient experience; and finally, ensuring positive physician and patient experiences through tailored education and guidance for patient management.

Importantly, as our educational efforts progress around awareness of folate receptor alpha and the adoption of early FR alpha testing, we see physician enthusiasm and support continue to grow in anticipation of potential approval later this year. Our partner, Roche Tissue Diagnostics is planning for the potential approval and commercialization of the companion diagnostic that will be used to test patients for folate receptor alpha expression at the time of mirv's launch. As a reminder, this diagnostic is an IHC test run on Roche Ventana's BenchMark ULTRA System, which has a large installed base that includes the majority of our target institutions' labs. At launch, we expect 2 to 4 central labs will be ready to accept patient samples for Day 1 testing readiness. Post-launch, institutions will have the ability to bring testing in-house if they so choose. To minimize access barriers, we plan to offer a sponsored testing program that will cover 100% of the cost of the test for patients.

As we prepare for mirv to come to market, access remains a key priority. To provide a range of services aimed at delivering a positive and seamless patient experience, our market access team is engaging with payers and working to finalize the build of our patient hub. We look forward to keeping you up to date on our commercial preparations as we get closer to launch.

With that, I will turn the call over to Susan to cover our financials. Susan?

Thank you, Kristen.

For the second quarter of 2022, we generated $14.2 million in revenue, $7.1 million of which came from non-cash royalty revenues and the remainder coming from substantially from license and milestone fees, which include recognition of $6.9 million of fees previously received under the company's collaboration agreement with Huadong Medicine.

Operating expenses were $75.2 million, comprised of $51.4 million of research and development expenses and $23.8 million of selling, general and administrative expenses. We ended the second quarter with $373.9 million in cash on the balance sheet.

Our financial guidance for 2022 remains unchanged, and we continue to expect revenues to be between $75 million and $85 million, operating expenses between $285 million and $295 million, and cash and cash equivalents at year end between $245 million and $255 million. Given the range and timing of the potential approval of mirv, revenue guidance does not reflect product sales. Operating expenses are expected to increase in the second half of the year as we continue to ramp up launch readiness activities, generate additional supply of mirv and further advance the pipeline. 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.

(Operator Instructions) Our first question comes from John Newman with Canaccord Genuity.

Just had one question to start. On the GLORIOSA study, just wondering if you'll be able to utilize the same centers that have recently completed the enrollment in MIRASOL, or if there will be some additional centers that you're using for GLORIOSA that are a bit different than the MIRASOL study.

Thanks, John. So GLORIOSA is our randomized Phase III study that we're in the process of initiating right now and look forward to enrolling patients later this year, looking at mirvetuximab plus bevacizumab maintenance in the recurrent platinum-sensitive setting versus bevacizumab alone. And we already have wonderful relationships with well over 100 sites -- actually over 200 sites from the MIRASOL study throughout the U.S., Europe as well as some countries in Asia Pacific. And so we certainly are going to invite them and already have engaged a bunch of sites to get up and running. And then we'll, of course, branch out into additional areas so that new countries, new sites, new investigators can have the opportunity to participate in mirvetuximab clinical trials, including GLORIOSA.

Okay. Great. And then if I could ask one additional question. You spoke about the initial plan for the diagnostic testing for folate receptor alpha. Do you have any expectation in terms of how long after launch individual centers might start to explore bringing the test in-house? Or is your plan simply to accommodate whatever path they choose and just to see kind of how that shakes out?

Sure. So thanks for that question. And what we have heard, based on speaking to our customer base, the larger institutions that have labs on site, they are very eager to start testing in-house. Of course, the time it takes for them to get trained and to start that process, we'll have central labs starting immediately upon approval so that it doesn't become a barrier in any way and that our customer base can utilize central labs while they bring it in-house. But we do hear that many of them want to have that capability.

Our next question comes from Michael Schmidt with Guggenheim Partners.

Yes, Mark, great to hear. It sounds like you had some confirmation from the FDA that there won't be a panel. Could you just share anything else around the BLA review process? I guess, how are you tracking with respect to CMC facility inspections, et cetera?

Thanks, Michael. So tracking as expected, given we're inside 4 months from the PDUFA date at this point. So, constructive dialogue in the midcycle review, and importantly, advice from the agency that they've got no plans for an advisory committee at this time. Inspections proceeding as one would expect at this point in time. We feel very good about where we are in the process with the agency. I think a blow by blow on sort of where we are in terms of individual components of the inspection wouldn't be helpful. But what I'd say is we're tracking as we would hope, given the timeframe relative to PDUFA.

Okay. Perfect. And then on IMGN632, where we'll get data later this year as well, just maybe could you help us frame the commercial opportunity in terms of the market potential for this drug? I know the sales figures in the market are a bit out of date, but I was just wondering how you think about the market size in terms of dollars in BPDCN initially.

Yes. So I think it's a little bit early to talk about kind of price. And so this is a rare indication, right? And even the epi data are a little bit thin. So our best estimates are there are somewhere between 500 and 1,000 newly diagnosed patients here in the U.S. and a similar sized market in Europe at this point. So rare disease, one would expect consistent with that pricing in the range of what one sees for rare oncology products. So I think if there's an effort to model this, I think those are the kind of benchmarks that I would look at. So again, rare indication.

I think the thing to focus on with this drug, though, is both the development strategy and the upside opportunity here. So what we've chosen to do is take a speed-to-market approach with BPDCN, focusing on the rare indication and align with FDA on this 20-patient study in frontline patients to try and get this drug approved in the near term, and then look at expanded indications to reach the full potential of the drug. And the lead there is, of course, AML. We have moved forward with expansion cohorts with the triplet in combination with venetoclax and azacitidine. We'll have data at ASH from the expansion cohorts, fully -- the relapsed patients and what we can gather on the frontline cohort. So we're excited about the opportunity. I think thinking about it, not dissimilar to mirv/rituximab, which is smaller indication, and then with an accelerated approval, our fast-to-market strategy and then significant upside from label expansion. So that's how we're approaching this molecule.

Our next question comes from Etzer Darout with BMO Capital Markets.

First one for me. Just if you can speak to the nature of the presentations for mirvetuximab at ESMO in IGCS and maybe what new data we could get at the meetings.

Sure, Etzer. So ESMO is early September in Paris. The abstracts will be released September 5. And we'll have a couple of clinical pharmacology abstracts, so physicians understand really the clin-pharm profile of our drug. And we're also going to have an abstract data presented from our patient-reported outcomes data from FORWARD I. The data that we collected in FORWARD I for patient-reported outcomes show an improved quality of life with regard to disease-related symptoms for mirvetuximab over chemotherapy, the magnitude of which looks like bev chemo over chemo. And so those data are really important to understand the potential benefit to patients in terms of their quality of life. And we use those data to inform the collection of quality of life data in the MIRASOL study that has completed enrollment and is on track for data early next year. At IGCS, which is at the end of September and early October in New York City, we're going to have long-term data from our combinations of mirv plus bev and mirv plus carboplatin, and we'll share additional information from the SORAYA study.

Great. And the enrollment update, I think, is an important milestone. And I guess -- for MIRASOL, that is. And I guess, I assume because we are only a few months away from the MIRASOL data readout, at least the top line, that I'd assume there's no plans for another interim look at MIRASOL. Is that correct?

That's correct.

Our next question comes from Boris Peaker with Cowen.

My first question is on the PICCOLO study. I'm curious, what do you need to see in the single-arm trial? And kind of maybe more generally, are you considering further development of mirvetuximab monotherapy in platinum-sensitive patients, or kind of what is the strategic focus of this trial?

So the PICCOLO study, mirv monotherapy in FR alpha high patients, later line platinum-sensitive disease. And this is a growing population for us whereas more and more patients are getting a PARP inhibitor as maintenance, either in the frontline setting or the recurrent platinum-sensitive setting, they are extending their platinum-free interval. And when they do relapse, they technically have platinum-sensitive disease with a PFI, or platinum-free interval greater than 6 months. And yet it's not like in the pre-PARP days when that meant that patients had nothing in between. Their tumor has been under continuous selective pressure from a PARP inhibitor, which can breed potential cross releases. So these patients with later line platinum-sensitive disease may not be as sensitive to yet another round of platinum. And the more platinum you get, the more you're at risk for hypersensitivity reactions that can be quite significant.

So in that context, we've already generated data from our Phase I study showing very nice, I would call it anecdotal activity for mirv in later line platinum-sensitive disease. And so we are enrolling the single-arm PICCOLO study to gather additional data that would then allow us to engage with FDA on what the benchmark would be in this newly emerging population. And I think that over the next year or so, we will see data being published. It's already beginning to come out, showing that patients who've had a PARP inhibitor are no longer quite as sensitive to platinum-based therapy. And I think the emerging data will help us align with FDA on a benchmark that will support potential approval from the PICCOLO study.

Got it. And just my last question on the CADENZA study. Can you set some efficacy expectations of what you look forward to?

So the CADENZA study, we aligned with FDA on a pivotal cohort of up to 20 patients with the primary endpoint being CR/CRc. This is the same endpoint that ELZONRIS used and allowed them to get approval in the frontline setting. And so from a statistical perspective, we aligned with FDA that we are ruling out a CR/CRc rate of 10%, knowing that really in this small population, we anticipate seeing response rates as good as or perhaps better than ELZONRIS and with a better tolerability profile in terms of no potential fatal capillary leak syndrome, you don't need to be hospitalized for the first cycle, less hepatotoxicity, less heme toxicity. And so FDA was quite encouraged with the data that we shared with them that led to breakthrough therapy designation, and then they guided us towards the design of this frontline pivotal cohort that is currently underway.

Our next question comes from Andy Hsieh with William Blair.

Congratulations on all the progress in the past couple of months. I do have a question for Mark. I think you mentioned that you successfully gone through the midcycle review. I am curious about the FDA's resection of the broad label that you proposed.

Yes. So, no label negotiations at this point. So I think the goal here is to get through the relative inspection tier on each of the core components of the application and then move forward with a discussion on the specifics of the label.

Got it. Got it. And one for Kristen. I'm curious about the 2 to 4 central labs that would be online right after your approval. I'm curious at this stage, how could you communicate that with physicians that could potentially use mirv in locations where there's no in-house equipment available? Is there a sort of detailed identity of these labs where they could just seamlessly kind of transition into that upon an approval?

Yes. So we actually surveyed a broad customer base of the most commonly used labs, and that's what helped guide us to identify. And we say 2 to 4. We think 2 would be sufficient, given how often they're used. But our plan is to get a broader base so that if someone has a preferred lab, they can use them Day 1 of approval, and that's the goal.

Got it. Got it. Great. And lastly, a question for Anna regarding kind of the primary platinum-free interval and subsequent platinum-free interval. I believe that the FORWARD I platinum -- about 40% of the patients in that study, the platinum-free interval between 0 and 3 is about 40%. I think SORAYA's primary refractory patients were excluded, but about 30% or 40%, also 0 to 3. Just curious about first for MIRASOL, are primary refractory patients excluded? And also, how would you expect that the secondary or subsequent platinum-free interval between 0 to 3 months will fall?

Sure, Andy. So SORAYA and MIRASOL both had the same exclusion criteria for patients with really, really bad disease. These are patients with primary platinum refractory disease who progress within 3 months of their last dose of their primary, their first platinum regimen. That's a little more stringent than what we did in FORWARD I. In FORWARD I, we excluded patients with a primary platinum-free interval of like a month. And so I would say overall, that has a slight effect of improving the population that PCed it for SORAYA and MIRASOL. But the percent of patients with primary platinum refractory disease is quite small. And so what I can say is SORAYA and MIRASOL are -- the eligibility criteria are essentially identical, except for SORAYA, you must have had prior bevacizumab. And so we anticipate that the demographics in MIRASOL will be quite similar to what we see in SORAYA.

Our next question comes from Kelly Shi with Jefferies.

Congrats on all the progress. The first question is for Anna. So recently, VBL's Phase III trial showed a 5.3 months of median PFS for paclitaxel arm in PROC setting. I'm just curious your thoughts on this. Is this viewed as outperformed the control arm? And should we expect a worse outcome for paclitaxel in for FR-high patients?

Thanks, Kelly. So the study that you're referring to added ofra-vec to paclitaxel and compared it to paclitaxel alone in platinum-resistant ovarian cancer. And both arms had a median progression-free survival, as you mention, of about 5.3 months. This is really disappointing for patients that this is not going to advance the field. But to your question around the 5.3 months there, we really look forward to seeing the demographics of the patients enrolled, because the eligibility criteria in their study is a bit different. They allowed patients with what was probably a pretty platinum-sensitive disease in the sense that they allowed patients with up to 5 prior lines of therapy. However, they excluded patients with 3 prior lines of therapy for platinum-resistant ovarian cancer. They also allowed patients with or without prior anti-angiogenic therapy. And so until we see the demographics, it's hard for me to put their PFS data into context, except to say that we know that prior therapies matter. I also don't know how many of them had a prior taxane 1 or 2 lines. And so certainly, there are other studies where the PFS has been in that range for paclitaxel.

But what I would point you to is we've already demonstrated an improvement in progression-free survival and even overall survival from a subset analysis perspective from FORWARD I. Even in our 10x FR alpha high subset that, as we know, is not as selective as a PS2-plus subset. And so we've already demonstrated a benefit from mirvetuximab over paclitaxel in FR alpha high patients, and I anticipate that we will do the same in MIRASOL. And to your point, it may be that patients with high FR alpha expression do have a worse prognosis. And you may recall that in our exploratory PS2-plus analysis, the control arm had a median PFS of 3.2 months and the mirvetuximab arm was 5.6 months.

I also have a follow-up. In terms of launch path, you previously mentioned targeting 4,600 physicians initially. Do you focus on academic centers and community settings equally, or you have a preference initially?

Sure. So we will absolutely focus on both academic and the community setting equally. When we look at our customer base and where the business will come from, there's a very concentrated call point, particularly among the higher utilization -- the folks who utilize chemotherapy or single-agent chemotherapy the most. So when we look at -- there's 400 physicians that account for 33% of the market, and they were equally split between academic and community. So the customer model, if you will, that we've designed has folks who are dedicated to the academic setting and folks who are dedicated to the community setting so that we can address both with a very tailored approach. And while we do see the academic setting being the first to adopt mirv because they already have hands-on experience from our clinical trial, what we also know in speaking to folks in the community, they are equally as eager to have an option for these patients that are really -- as they say, their backs are against the wall and they have nothing to give them, so they are equally eager to have mirvetuximab available.

Our next question comes from Swayampakula Ramakanth with H.C. Wainwright.

This is RK from H.C. Wainwright. Most of my questions have been answered, but I have just couple of quick ones. So Kristen, thinking about the launch of mirv, what sort of commercial structure are you planning to have, especially when you're trying to tailor your forces for both academic and to the community physicians?

Sure. So our commercial model will comprise of 45 field associates. We have 15 what we call strategic account managers, and they are provider account managers. They will cover those top tier institutions, the academic settings that are a little harder to navigate, but yet at the same time, do have mirvetuximab experience. Then we have 30 field associates, oncology field specialists who will focus on the community practices and be responsible for driving demand there. They're a little easier to navigate, but at the same time, equally as important when it comes to where chemotherapy has been used. And that is really what mirvetuximab will be replacing upon launch.

And then, Anna, regarding pivek, so with your data from CADENZA coming out in the fourth quarter, what are the plans in terms of filing and then time line for filing that application with the FDA?

Yes. So we haven't disclosed at a granular level what our time line is for the BLA there, RK. Certainly, CR/CRc is the primary endpoint, and duration of complete response is also an important endpoint. So taking that into consideration, once we've locked into a BLA time line and can provide guidance, we certainly will share that.

Our next question comes from Jonathan Chang with SVB Securities.

First question, just for clarity. For MIRASOL, are you still expecting to requisite number of events for primary analysis in the fourth quarter?

Yes.

Got it. And second question. Just as you think about the mirvetuximab commercialization strategy, how are you thinking about ocular toxicities and potential barriers to commercial uptake?

Sure. So I can start, and Anna, chime in if you want. But our goal with the commercial launch is to establish mirvetuximab as the standard of care for platinum-resistant ovarian cancer patients with FR alpha high expression. At the same time, we are anticipating that we might need to remove any barrier that could get in our way. You think about market access. We have a market access team that is removing any barriers around cost out of pocket for patient, reimbursement challenges. We also have our team that is focused on making sure that we manage expectations around ocular adverse events. And we will do this not only by having our local teams work with their prescriber base to understand which ophthalmologists their patients go to, and educating both the ophthalmologists plus the physicians and infusion nurses so that they can manage expectations and manage them that the ocular AEs that we see with mirvetuximab are generally low grade and they resolve. And also, when they can expect them if they do get them. So we will have a full educational effort around this. And what we do hear from folks in our trial is that once they experience something, they know what to expect, and they can best educate their patients.

Yes. And I would just add that in the clinical trials, as we expanded our reach to more and more sites who were new to mirvetuximab, I think the clinical trial data speak to the fact that mirvetuximab is really well tolerated. And we've had less than 1% of patients discontinue for ocular adverse events. And so we're sharing those lessons learned from an education perspective with our commercial colleagues so that we can really successfully do this together.

There are no further questions. I'd like to turn the call back over to the team for closing remarks.

Great. Well, thanks for joining us this morning. We had a very productive first half of the year. And with some key regulatory clinical milestones as well as our first product approval ahead of us in the back half of this year, we're excited about the prospects of the business and look forward to keeping you updated on our progress. Thanks again, and have a nice weekend.

This concludes the program. You may now disconnect.