ImmunoGen, Inc. (NASDAQ:IMGN) Q4 2022 Earnings Call Transcript

ImmunoGen, Inc. (NASDAQ:IMGN) Q4 2022 Earnings Call Transcript March 1, 2023

Operator: Good morning, and welcome to ImmunoGen’s Fourth Quarter and Full Year 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.

Anabel Chan: Good morning, and thank you for joining today’s call. Earlier today, we issued a press release that includes a summary of our recent operating progress and fourth quarter and full year 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 Enyedy, our President and CEO; Anna Berkenblit, our Chief Medical Officer; and Renee Lentini, our Interim-CFO. Michael Vasconcelles, our EVP of Research, Development and Medical Affairs; and Todd Talarico, our Interim-Chief Commercial Officer will 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 Factors section of our most recent annual report on Form 10-K and in our other SEC filings, which are available at sec.gov and immunogen.com. With that, I’ll turn the call over to Mark.

Mark Enyedy: Thanks, Anabel. Good morning and thank you for joining us today. 2022 was a landmark year for ImmunoGen with significant progress on multiple fronts highlighted by the approval and launch of ELAHERE as the first and only ADC for the treatment of platinum-resistant ovarian cancer encouraging data from our second pivotal program, PVAC advances in our early stage programs, including reaching the recommended Phase 2 dose for 936 and initiating Phase 1 development with 151, rebuilding our rebuilding our pipeline through collaborations with Oxford BioTherapeutics and , and strengthening our management team with Michael Vasconcelles in a newly created role as Executive Vice President, Research, Development and Medical Affairs; and Daniel Char, as General Counsel.

In addition, this morning, we were pleased to announce a global multi-target license and option agreement with Vertex. We are excited to partner with a leader in transformative medicines and believe this deal nicely reflects our continued innovation in the ADC space and demonstrates the value of our technology platform and related intellectual property. With the momentum generated over the last 12 months, we look forward to a number of important milestones in 2023 that will include building on the strong start to the ELAHERE launch, about which I’ll have more to say in a moment, reporting data from our confirmatory MIRASOL trial and submitting regulatory filings to support full approval of ELAHERE in the EU and U.S., sharing ORR data from PICCOLO in platinum-sensitive disease, completing enrollment in our pivotal BPDCN study and updating data from expanded frontline cohorts in AML with PVC and reporting top line data from the expansion cohorts with 936.

So we’re proud of what we accomplished over the last 12 months and look forward to an exciting and productive year ahead as we grow our business, drive value for shareholders and deliver more good days for patients. So just a few qualitative updates on the ELAHERE launch. We are now just three months in and seeing strong performance across each of the key imperatives we set for the business. First, uptake has been broad and deep. As a reminder, our first patient was treated on December 1, and we generated $2.6 million in net sales for the quarter, nearly all of which came in December. Through the end of 2022, roughly 70% of our orders came from nonacademic settings and 75% of our orders from accounts with no prior ELAHERE experience, which is a strong indicator of the breadth and depth of adoption.

In the new year, revenue growth has accelerated as we are seeing a significant percentage of accounts, with repeat orders complementing new patient starts. Turning to testing. Strong demand continues for the full R1 diagnostic through the four central labs set up in collaboration with our CDx partner, Roche. In addition, we’re also seeing new labs request certification to run the test in-house, which we believe is another favorable sign of physician and patient interest. Through the end of 2022, we estimate that roughly 1,500 tests have been performed, and that volume has increased as we have moved into the first quarter. Consistent with our education efforts, we believe a significant percentage of these tests are being ordered for newly diagnosed patients.

While these patients are not eligible for treatment with ELAHERE today, this will enable oncologists to rapidly incorporate ELAHERE into their future treatment decisions. In addition, our tracking indicates that FR alpha positivity rates remain consistent with our clinical trial experience of between 35% and 40%. Regarding coverage, we’re again off to a fast start in terms of access with a growing number of national and regional payers, including ELAHERE on coverage policies aligned to our label. Recall that as of early January, 18% of Medicare and 25% of commercial lives recovered, driven by the efforts of our access team, coverage has rapidly increased this quarter. We were also pleased to see ELAHERE was added to the NCCN guidelines in December as both monotherapy and in combination with bevacizumab.

Finally, our customer-facing teams are highly active in terms of reach. As of the end of December, our commercial and medical teams have connected with 70% of their priority targets, with these numbers continuing to increase in the new year. Finally, our teams report that feedback from medical experts and clinicians for ELAHERE has been enthusiastic, and we are leveraging these customer insights to ensure positive physician and patient experiences as we move forward. So as you can see, we’ve made strong progress in the early months of launch and are excited about this momentum through the rest of the year and look forward to reporting the quantitative metrics for the first quarter during our next earnings call. With that, I’ll turn the call over to Anna to provide additional color on our ongoing development programs.

Anna?

Anna Berkenblit: Thanks, Mark. We are thrilled with ELAHERE’s accelerated approval and excited by the early feedback we are receiving in the field from health care providers. We’re pleased that data from the SORAYA study, which supported ELAHERE’s accelerated approval were published in the Journal of Clinical Oncology in January. In February, the safety and efficacy data of MIRV in combination with bevacizumab in platinum-resistant ovarian cancer, which supported its inclusion in NCCN guidelines, were published in Gynecologic Oncology. We look forward to an active year ahead, including the presentation of additional efficacy data from SORAYA by sequence of treatment as well as the final overall survival analysis at SGO later this month in Tampa.

While it has taken a little bit longer than anticipated to reach the requisite number of PFS events, we will imminently reach the 330 PFS events needed to trigger the primary analysis in the confirmatory MIRASOL trial, and we now expect to announce top line data in the second quarter. Based on the totality of data generated with ELAHERE today, we are excited about the prospect of this trial, demonstrating improvement over investigators’ choice chemotherapy and supporting full approval of ELAHERE in the U.S. and submission of an MAA in Europe. Let me now turn to the broader MIRV development program, which has the potential to meaningfully expand the ELAHERE label. In January, we completed enrollment in Piccolo, our single-arm study of MIRV monotherapy in recurrent platinum-sensitive ovarian cancer patients with high FR alpha expression.

We expect data on the primary endpoint of ORR before the end of this year. As we look to position MIRV as the combination agent of choice in ovarian cancer, we are progressing two studies. The first is our Phase 3 GLORIOSA study evaluating MIRV plus bevacizumab maintenance versus standard of care bevacizumab maintenance in the second-line platinum-sensitive setting. With the robust data we’ve generated for this combination in the platinum-resistant setting supporting NCCN compendia listing, we are excited to move this combination up into the platinum-sensitive setting where patients have the potential to benefit from even longer treatment duration. The second is trial 420, a single-arm Phase 2 study evaluating mirvetuximab plus carboplatin, followed by mirvetuximab continuation in platinum-sensitive ovarian cancer patients with low, medium and high levels of FR alpha expression.

Both trials are up and running in the U.S., with enrollment having begun in Study 420, and we are actively working on opening both studies in Europe. In parallel with the significant advances we have made on the MIRV program, we are also pleased with the recent progress of PVAC in both BPDCN and AML. As you may recall, we previously aligned with FDA on a pivotal frontline cohort of up to 20 patients in our Phase 2 CADENZA study as a path to full approval, with CR/CRc as the primary end point and duration of CR/CRc as a key secondary endpoint. In an initial analysis of data from this study, we were encouraged with the activity seen in both de novo and PCHM patients, or patients with a prior or concomitant hematologic malignancy, with 11 of 13 or roughly 85% of patients achieving some form of complete response.

In discussion with FDA, we aligned with the primary efficacy evaluable population will be in de novo BPDCN patients. Enrollment in CADENZA has increased following the release of these initial data, and we expect to complete enrollment before the end of this year and report top line data from the de novo cohort in 2024. In AML, we presented, as part of our fourth consecutive oral presentation at ASH, promising efficacy data findings from dose escalation and expansion cohorts of the 802 study. This Phase 1b/2 study is evaluating PVAC with venetoclax and azacitidine in patients with relapsed/refractory and frontline AML. This novel triplet showed manageable safety profile and strong anti-leukemia activity, with an objective response rate of 45% and composite complete remission or CCR rate of 25% in our expanded relapsed/refractory cohort.

We observed compelling CCR rates across various relapsed/refractory patient subgroups. And importantly, in our initial frontline cohort, 50% of patients achieved a CR. Based upon the encouraging results from these first 10 frontline patients enrolled, we have moved forward rapidly with gathering more data for the triplet using 14 days of venetoclax and recently completed enrollment of this cohort. Separately, we are seeing strong recruitment in a second cohort of up to 50 frontline patients with the goal of evaluating up to 28 days of the venetoclax per cycle to optimize the duration of therapy. Tolerability and efficacy outcomes from these cohorts will guide pivotal development of the triplet in frontline AML. In addition, our recently announced clinical collaboration with Gilead will evaluate the safety and anti-leukemia activity of PVAC in combination with magrolimab and will comprise a new cohort of up to 42 patients with relapsed/refractory CD123-positive AML in the 802 study.

We plan to initiate, this new cohort in our ongoing 802 study later this year, with complete response rate as the primary endpoint. Turning now to the rest of the pipeline, we’ve completed dose escalation with IMGC936 and are focused on expanding to non-small cell lung cancer as well as triple-negative breast cancer. We look forward to sharing data from the Phase 1 dose escalation and our initial experience on these expansion cohorts in Q2 of this year. In addition, we advanced our Phase 1 study of IMGN151, our next generation FR alpha targeted ADC by dosing our first patients in January and look forward to continuing patient enrollment this year. So, great progress in 2022 and we’re looking forward to an eventful 2023. With that, I’ll turn the call over to Renee to cover the financials.

Renee Lentini: Thanks, Anna. For the full year 2022, we generated $108.8 million in revenue, including $76 million of license and milestone fees $2.6 million in net product sales of ELAHERE and the remainder from non-cash royalty revenues. Operating expenses were $329.5 million comprised of $213.4 million of R&D expenses, compared with $151.1 million in 2021 and $116.1 million of SG&A expenses compared with $43.8 million in the prior year. We ended 2022 with $275.1 million in cash on the balance sheet. Turning to our financial guidance for 2023, we expect revenues excluding product revenue from ELAHERE to be between $30 million to $35 million and operating expenses between $310 million and $320 million. We expect to provide ELAHERE product revenue guidance later this year.

Excluding anticipated ELAHERE and collaboration revenue, our level of cash and cash equivalents as of December 31, 2022 alone is not sufficient to meet our current operating plan through March 1, 2024. With the addition of forecasted ELAHERE product revenue and milestone payments under existing collaboration agreements, we expect these amounts combined with existing cash will fund operations for more than 12 months, from the date of this release and we intend to raise additional funds through equity, debt or other financings. With that, we’ll open the call for questions.

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Q&A Session

Operator: Thank you. Our first question comes from the line of John Newman with Canaccord Genuity. Your line is now open.

John Newman: Hello, guys. Good morning. Thank you for taking my question. I just want to confirm on the top line data readout from MIRASOL that, will of course include the mature PFS data as expected. And some information on overall survival, which I believe you previously said would be immature, but you’d follow long-term. Also curious on the ELAHERE launch, just wondered what you’re seeing here in terms of combination use with Avastin at the moment? Thanks.

Anna Berkenblit: Yes, so John, you’re right that our primary PFS analysis were imminent in terms of triggering it based on the 330 requisite events. And when we have top-line data, we will share PFS data. We will also share initial OS data. In terms of the level of maturity of OS data, we anticipate that there will be probably about greater than 60% of the overall survival events. So while it’s not the final OS analysis, we anticipate that the OS data will indeed be mature enough for regulators to understand the benefit of mirvetuximab and then of course we will have the final OS analysis later when we hit the requisite number of events for that. Now I’ll turn it over to Todd.

Todd Talarico: Yes, thank you. John, at this time from an Avastin combination, approach where you don’t have the data yet to really evaluate the utilization of ELAHERE as a monotherapy or in combination, but as we get additional patient data, we’ll probably have a better idea of that in the next quarter or so.

John Newman: Great, thank you.

Operator: Thank you. Our next question comes from the line of Michael Schmidt with Guggenheim. Your line is now open.

Michael Schmidt: Hi, guys. Thanks for taking my questions. I had one regarding the upcoming PICCOLO data later this year. Just wondering how we should think about the regulatory bar in terms of response rate. I think in the platinum-resistant setting, we’ve talked about the 12% hurdle rate for chemotherapy. Is that similar in the platinum-sensitive setting for PICOLLO? And then circling back to 936, I know you’ve talked about presenting data in the second quarter from dose escalation, early expansion cohorts. Just wondering if you could give us some more color on the sort of the quantity of the data, how many patients are in the expansion course at this point. Thanks so much.

Anna Berkenblit: Sure. So in terms of the regulatory bar for recurrent platinum-sensitive ovarian cancer, and I would say, later line patients, so with two or more priors, there is no clear bar, unlike in the platinum-resistant setting where we aligned with FDA as you pointed out, on 12% based on multiple Phase 3 trials with investigator choice chemotherapy. In the later line recurrent platinum-sensitive setting, this is an evolving, emerging and growing unmet need with more patients falling into this category after having had a prior PARP inhibitor as maintenance. Recent data have shown indeed that PARP inhibitors may result in cross resistance, so that even if patients technically have platinum-sensitive disease, they may not be as sensitive as they were previously, in the pre-park days, if you will.

And so while there are some studies out there that we can use, both in terms of platinum and nonplatinum-based combinations, particularly in patients with BRCA mutations, which are only about 20%, 25% of patients, we have a sense of what the efficacy is, but we would really need to engage with FDA on what the bar would be. And all I can say is the greater the activity of mirvetuximab in the PICCOLO study, the easier that conversation will be. Moving to your second question on 936, we do anticipate sharing data in Q2 on the findings from dose escalation. So we’ll be able to talk about dose escalation, the recommended Phase 2 dosing schedule and a little bit of color about how we got there. And then we’ll be able to provide initial data on expansion cohorts in triple-negative breast cancer and non-small cell lung cancer.

I think we’ll be able to share sufficient data on triple-negative breast cancer. We may hold off on sharing data from lung cancer — from non-small cell lung cancer because we like what we’re seeing so far, and we might just want to continue enrolling before we give a complete view of those data.

Michael Schmidt: Thank you.

Operator: Thank you. Our next question comes from the line of Etzer Darout with BMO Capital Markets. Your line is now open.

Etzer Darout: Great. Thanks for taking the question. One for me, maybe a little bit too immature given your earlier commentary. But I just wondered if you had a sense sort of the percentage of patients that are being given ELAHERE pre-bevacizumab. And any color on the ELAHERE sort of patient experience for those patients given sort of mirvetuximab, pre-bev and again, I think that kind of goes around sort of getting to the relative unknown, if you will, from MARISOL outcome. And if you could kind of gain any incremental insights into that based on patients given that the drug sort of pre-bev versus post bev.

Mark Enyedy: Let me start answer and then I’ll ask Todd if he wants to add any color. So as Todd alluded to, our best available data will come from evaluating claims data. It’s very early in terms of the generation of those data from the external sources. And so for example, while we do see mirv-bev use, for example, sort of trying to fix the percentage given the early days of the data inputs, I think, would not be productive. Similarly, looking at the question of whether a patient has received prior bev, again, too early to tell. But what I would say is the feedback that we’re getting from the field anecdotally continues to be highly enthusiastic in terms of the use of the drug and managing patients on an ongoing basis. As I mentioned, we see an increasing percentage of repeat orders to complement the new patient starts, which is encouraging.

And we are in very close contact with the accounts as new patient starts through ophthalmology referrals and then any follow-up questions, starting with this basic thing is infusion to manage events as we go forward. So from a quantitative perspective, as I say, the data — the claims data are just too early to give kind of definitive guidance in terms of breakdown of combo versus mono and where the line of treatment is and what the prior treatments were.

Etzer Darout: Got it.