Analyst Conference Summary

conference date: November 4, 2022 @ 5:00 AM Pacific Time
for quarter ending: September 30, 2022 (Q3, third quarter 2022)

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

Overview: Note that after this conference, on November 14, the FDA approved Elahere (mirvetuximab soravtansine-gynx) for platinum-resistant ovarian cancer.

Basic data (GAAP):

Revenue was $15.4 million, up sequentially from $14 million, and up from $9.2 million year-earlier.

Net income was negative $77.8 million, down sequentially from negative $62 million, and down from negative $37.3 million year-earlier.

Diluted EPS was negative $0.31, down sequentially from negative $0.24, and down from negative $0.18 year-earlier.

Guidance:

End of year cash betwee $230 and $240 million. Believes funded into 2024.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "With approval expected on or before our November 28, 2022 PDUFA date, we have completed our preparations to launch mirvetuximab this month. Our commercial and medical teams are in the field, our distribution network is in place, and our patient support infrastructure is ready to deliver mirvetuximab to ovarian cancer patients with platinum-resistant FRa-positive disease."

Revenue was not from product sales. $7.4 million was from license and milestones; $8 million was non-cash royalties; $0 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. PDUFA is November 28, 2022. Full data from the Soraya trial was presented at SGO in March 2022. A single arm study, Piccolo, for platinum-sensitive ovararian cancer is open for enrollment. Confirmatory Mirasol study completed accrual, 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. In Q2 received a $13 million upfront payment.

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 $309 million, down sequentially from $374 million. Other long-term liabilities at $42 million.

Operating expenses were $93 million consisting of: $ million R&D; $34 million general and administrative. Income from operations negative $7 million. Non-cash interest expense of on future royalty $1 million. Other income $0.5 million. No tax.

Q&A selective summary:

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