Analyst Conference Summary


conference date: May 1, 2020 @ 8:00 AM Pacific Time
for quarter ending: March 31, 2020 (Q1, first quarter 2020)

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

Overview: Initiated redo ovarian cancer trial.

Basic data (GAAP):

Revenue was $13.3 million, down sequentially from $44.9 million, and up from $8.6 million year-earlier.

Net income was negative $29.1 million, down sequentially from $4.8 million, and up from negative $43.8 million year-earlier.

Diluted EPS was negative $0.17, down sequentially from $0.03, and up from negative $0.30 year-earlier.



Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "During the last quarter, we moved forward with our registration studies for mirvetuximab and advanced our portfolio of earlier-stage candidates, while adapting to meet the evolving challenges of the COVID-19 pandemic. Our lead program remains on track with the initiation of our pivotal SORAYA trial and patient enrollment in our confirmatory MIRASOL trial progressing as anticipated. In parallel, we continue to follow our FORWARD II combination cohorts and we are pleased to have initial data from our Avastin expansion cohort in platinum-agnostic ovarian cancer selected for a virtual oral presentation at ASCO in May."

Immunogen dosed the first patient in the Phase 3 trial (MIRASOL) for mirvetuximab soravtansine in folate receptor alpha (FRa)-high platinum-resistant ovarian cancer in Q1 2020. Top line data could be available in first half of 2022.

Believes a sampling method for patients in the failed trial gave higher FRa than it should have, contributing to the failure by introducing low-FRa patients into a trial supposed to see treatment effects in high-FRa patients.

In Q2 2020 initiated SORAYA, a new single-arm study in platinum-resistant ovarian cancer for women previously treated with Avastin (bevacizumab), which is designed to support accelerated approval for mirvetuximab. Had received guidance from the FDA that SORAYA, could support accelerated approval for mirvetuximab with a BLA submission in the second half of 2021.

Revenue by category: license and 0.3 $ million; non-cash royalty revenue $13.0 million; R&D reimbursement $0.0 million; clinical materials $0.0 million.

IMGN632 Phase 1 for a AML is a CD123-targeting ADC with a DNA-alkylating payload. It is intended to treat "a range of hematological malignancies, including AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN).". Granted orphan drug designation. More data from cohorts before year end 2020. In Q1 2020 continued IMGN632 monotherapy in Phase 1 expansion cohorts in patients with AML, BPDCN, relapsed acute lymphocytic leukemia (ALL), and minimal residual disease positive (MRD+) AML patients following frontline induction therapy. Advanced IMGN632 combination therapy studies with Vidaza (azacitidine) and Venclexta (venetoclax) in relapsed/refractory unfit AML patients.

IMGC936, from the ADAM9 ADC program, in collaboration with Macrogenics is in IND enabling activity, with likely filing in Q2 2020.

IMGN151 is transitioning into preclinical development. It also targets FRa.

A next generation anti-folate alpha (FRa) molecule is being readied for preclinical work.

Cash and equivalents ended at $247 million, down sequentially from $176 million. Other long-term liabilities at $107 million. In January 2020 raised $98 million in a follow-on stock offering. Believes cash could last through first approval of mirv.

Operating expenses were $37 million consisting of: $27 million R&D; $9 million general and administrative; restructuring $1 million. Loss from operations $24 million. Non-cash interest expense of on future royalty $5 million. Other income $0.4 million. No tax.

Q&A summary:

FORWARD II at ASCO, had some patients received Avastin? Cohort of new patients, some had received prior Avastin, but it was not a requirement.

Platinum agnostic cohort? FRa expression has been uniform over lines of therapy irrespective of prior treatment: about 40% of ovarian cancer patients express at high levels. We will be using the PS2+ scoring method.

Epitope, linker in 151? ADC with two epitope binding sites for FRa. Preclinical shows more effective, particularly with tumors with lower expression. The linker is also improved. Payload is more hydrophobic for better activity. More binding means better internalization. There is potential for a better safety profile.

Recurrent platinum sensitive trial? No difference across the arms from mirv to standard of care. Typically 4 to 8 cycles of carboplatum before moving to mirv.

FRa competive landscape? We see the potential to launch mirv in 2022 into an open field. PARP inhibitors are the main competition at present. FRa competitors are in earlier trials. We believe we can achieve label expansion with combinations.

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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 2020 William P. Meyers