Analyst Conference Summary


conference date: May 6, 2022 @ 5:00 AM Pacific Time
for quarter ending: March 31, 2022 (Q1, first quarter 2022)

I owned from 2016 to Dec. 17, 2019 and may buy again in the future.
Forward-looking statements

Overview: Made a submission to the FDA for its first commercial cancer drug approval.

Basic data (GAAP):

Revenue was $38.1 million, up sequentially from $na million, and up from $15.7 million year-earlier.

Net income was negative $23 million, up sequentially from negative $37 million, and up from $29 million year-earlier.

Diluted EPS was negative $0.10, up sequentially from negative $0.17, and up from $0.17 year-earlier.


Maintained prior guidance.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "Following the presentation of the results from our positive pivotal Soraya trial at SGO, we were pleased to submit the BLA to support the accelerated approval of mirvetuximab monotherapy in FRa-high platinum-resistant ovarian cancer. We requested Priority Review for the BLA and look forward to acceptance towards the end of May and a PDUFA date on the application later this year. In preparation for potential commercialization, we have significantly ramped our launch readiness activities, with a focus on increasing mirvetuximab and FRa awareness among prescribers."

Revenue was not from product sales. $30.9 million was from license and milestones; $6.4 million was non-cash royalties; $0.7 million was from research support.

The BLA for mirvetuximab for platinum-resistant FRa positive ovarian cancer was filed in Q1 2022, under the accelerated approval process. Full data from the Soraya trial will be presented at SGO in March 2022. Positive mature data from the FORWARD II platinum-sensitive triplet cohort evaluating mirvetuximab in combination with carboplatin and Avastin were presented ASCO 2021 in June. A single arm study, Piccolo, for platinum-sensitive ovararian cancer is open for enrollment. Confirmatory Mirasol study continues with data expected in Q1 2023. Received FDA approval for the design of Gloriosa Phase 3 trial in combo with bevacizumab maintenance, initiation expected in midyear 2022.

Given the success and the cash, Imunogen is refocusing on its drug research and development efforts. Label expansion, once a label is granted, appears to be a priority.

Imunogen advanced dose escalation in the Phase 1 study of IMGC936 in multiple solid tumor types in Q1 2022. Should have first data before year-end 2022.

Immunogen and Eli Lilly deal announced in February to commercialize ADCs.

Plans to enroll the first patient in PICCOLO, a single-arm study of mirvetuximab monotherapy in high FRa recurrent platinum-sensitive ovarian cancer, designed to support potential label expansion.

IMGN632 (now pivekimab sunirine) ongoing Phase 2 for a AML is a CD123-targeting ADC with a DNA-alkylating payload. Positive Phase 1 combination data for AML was presented at ASH in Q4 2021. Plans expansion cohorts in 2022. Enrolling a cohort of up to 20 frontine blastic plasmacytoid dendritic cell neoplams (BPDCN) patients with data later in 2022. It is intended to treat "a range of hematological malignancies, including AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN).".

IMGN151, a next generation anti-folate alpha (FRa) molecule made its IND submission in Q1 2022.

Cash and equivalents ended at $438 million, down sequentially from $479 million. Other long-term liabilities at $44 million.

Operating expenses were $61 million consisting of: $44 million R&D; $17 million general and administrative. Income from operations negative $23 million. Non-cash interest expense of on future royalty $1 million. Other loss $0 million. No tax.

Q&A summary:

Mirosol enrollment pickup, timeline? Still 430 total patient target. Expect full enrollment this summer. Topline data early next year. 330 PFS events trigger data readout.

Compendia listing for mirv plus avastin? Should get closely after approval. In platinum resistant many patients receive avastin; anticipate avastin use will remain about the same including combining with mirv.

Mirosol had a pre-specified futility analysis. That was at 110 PFS events.

We do have sites that participated in Soraya and are now doing Mirosol. Soraya required Avastin combination. Mirosol seeing about the same % prior treatment with Avastin.

Point of enrolling low FRa patients? We now know that the high FRa benefit most from monotherapy, but lower FRa patients do respond to combination therapies. Small data set, so we are expanding to a larger trial. Combination should benefit a broad range of FRa expression.

FDA Ad Com? Actively engaged with FDA. Don't know yet about Ad Com.

Mirv label? Asking for a broad label. Don't know what the FDA will do.

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Disclaimer: My analyst call summaries may include both condensations of statements made by company representatives and my own analysis. They are not covered by any warranty. I cannot guarantee anything said by company representatives is true. I try not to make errors, but it is possible. These are my personal notes which I share with other investors and which I use as the basis of my Seeking Alpha articles.

Copyright 2022 William P. Meyers