ImmunoGen, Inc.

Good morning and welcome to Imogen's second 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 Annabel 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 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 Enneby, our President and CEO, Isabel Calafonos, our Chief Commercial Officer, Anna Birkenblit, our Chief Medical Officer, and Renee Lentini, our Interim CFO. Michael Vasconcells, our EVP of Research Development and Medical Affairs, will also join us for Q&A. During today's call, we will review recent progress for the business, our financial results, and highlight upcoming anticipated events. We will be making forward-looking statements based on our current expectations and beliefs. These statements are subject to risks and uncertainties, and our actual results may differ materially. Please consult the risk outlined in our press release issued this morning in the risk factor 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.

Thanks, Annabelle. Good morning, everyone, and thank you for joining us today. You will have seen this morning's press release announcing that Anna will be stepping down from her position as Immunogen's Chief Medical Officer to take a well-deserved professional hiatus prior to pursuing new opportunities. I would like to take a moment to personally acknowledge and thank her for the essential role she has played in the transformation of this company. We've encountered no small amount of adversity as we navigated the last four years at Immunogen. Through it all, Anna rose to the challenge with intellect, grit, and good humor. Of particular note, she led the design and execution of the pivotal development program for Elihir that culminated in an FDA accelerated approval late last year and the unprecedented survival data shared at ASCO in June that have transformed the treatment landscape for patients with FR-alpha positive ovarian cancer. In parallel, under her leadership, We've also advanced our broader clinical pipeline, including a second pivotal program, and built a highly talented development organization. Anna, I value you as a colleague and wish you the very best in your future endeavors. On behalf of Immunogen, our collaborators, and most importantly, patients in need of more good days, thank you. Moving to our second quarter results. Since our last call, we've made great progress on multiple fronts and achieved a significant milestone for patients in our organization with our confirmatory phase three Mirasol trial, meeting not only the primary endpoint of progression-free survival, but also objective response rate, and most importantly, overall survival. This is an unprecedented result in platinum-resistant ovarian cancer, making Elihir the first novel therapy to demonstrate an overall survival benefit versus chemotherapy in a Phase III trial. With these results now in hand, we anticipate submitting an MAA in Europe and the SBLA in the U.S., both in the fourth quarter of this year. Turning to our commercial performance, we delivered a strong quarter with Elihir generating over $75 million in net sales, more than doubling our Q1 result with increasing breadth and depth of adoption. Isabel will provide more detail on our progress with the launch in a moment. As an initial point, given that this is just our second full quarter on the market, coupled with recent developments with both Elihir and the broader ovarian cancer landscape, we've elected not to provide full year guidance for LE year revenue today. The basis for this decision is this. We simply have not yet accumulated sufficient data and experience to confidently project the trajectory for LE year over the back half of this year. The key variables underlying this decision include Evolution of treatment rates. Given the compelling efficacy of Elihir, we believe treatment rates may be increasing over historical benchmarks, particularly for later Lyme patients. Shifting from prevalent to incident populations, which may potentially affect the growth rate of new patient starts. Duration of therapy. The claims data, which lag the market by 90 days or more, are not mature enough for us to provide a reliable forecast of how long patients are remaining on therapy at this time. Mix of testing and initial diagnosis versus testing to initiate treatment. And finally, monotherapy versus combination use. We are tapping multiple data sources to assess the percentage of combination use, which have yielded somewhat disparate outputs up to this point. Our clinical data suggests that combination use tends to generate higher response rates and longer durations of response, so an accurate assessment of this use is important. You will appreciate that each of these variables can have a significant impact on adoption and adherence. To better assess the evolving market here, we have commissioned a demand study with the goal of increasing our confidence in assessing trends and the growth trajectory for the product. In addition, our existing vendors are updating their databases and we are evaluating additional sources to gather more insights into the market. We look forward to updating you on our progress on these activities during subsequent calls. In terms of ongoing development, we are advancing our efforts to move Elihir into broader patient populations and to position it as the combination of choice in ovarian cancer. We look forward to our next milestone for the Elihir program with ORR data from our PICOLO trial expected before the end of the year. Moving to our PVEC program. We've completed enrollment in the pivotal de novo patient cohort of the CADENZA trial and expect top-line data in 2024. In addition, we progressed our 802 trial of PVEC in combination with Veneza for newly diagnosed AML patients and look forward to reporting data from these frontline cohorts at ASH later this year. Looking at the rest of the pipeline, IMGC 936 and IMGN 151 are progressing. and we remain focused on reinvesting in our research capabilities and expanding our pipeline. Together with a strong balance sheet bolstered by our follow-on offering, our progress over the first six months of the year has positioned us well to create meaningful value for our patients and our shareholders in the second half of 2023 and well beyond.