Analyst Conference Summary

conference date: February 25, 2022 @ 5:00 AM Pacific Time
for quarter ending: December 30, 2021 (Q4, fourth quarter 2021)

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

Overview: Ovarian cancer Phase 3 trial reported positive results. Lots of cash.

Basic data (GAAP):

Revenue was $28 million, up sequentially from $9 million, but down from $86 million year-earlier.

Net income was negative $37 million, flat sequentially from negative $37 million, and down from $31 million year-earlier.

Diluted EPS was negative $0.17, up sequentially from negative $0.18, and down from $0.16 year-earlier.

Guidance:

Full year 2022 revenue expected between $75 and $85 million. Operating expense $285 to $295 million. Cash at year end between $245 and $255 million.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "The top-line SORAYA data provide the opportunity to establish mirvetuximab soravtansine as the new standard of care for patients with FRa-positive platinum-resistant ovarian cancer, and we look forward to presenting detailed results from SORAYA during the plenary session at SGO next month. We also formalized our plans to expand mirvetuximab into platinum-sensitive disease as a monotherapy and in combinations to serve a broader population of ovarian cancer patients, presented promising initial data for IMGN632, now known as pivekimab sunirine, in relapsed/refractory AML and frontline BPDCN at ASH, continued dose-escalation for IMGC936, and submitted the IND for IMGN151." Building a sales organization.

Revenue was not from product sales. $19.6 million was from license and milestones; $8.0 million was non-cash royalties; $0.4 was from research support.

The BLA for mirvetuximab for platinum-resistant FRa positive ovarian cancer is anticipated to be filed in Q1 2022. 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 Q3 2022. Received FDA approval for the design of Gloriosa Phase 3 trial in combo with bevacizumab maintenance, initiation expected in Q2 2022.

Given the success and the cash, Imunogen is refocusing on its drug research and development efforts.

Imunogen advanced dose escalation in the Phase 1 study of IMGC936 in multiple solid tumor types in Q1 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 $479 million, up sequentially from $246 million. Other long-term liabilities at $2 million. In Q4 generated $295 million through ATM stock sales.

Operating expenses were $63 million consisting of: $49 million R&D; $14 million general and administrative. Income from operations negative $35 million. Non-cash interest expense of on future royalty $2 million. Other loss $0.5 million. No tax.

Q&A summary:

PFS Soraya? At SGO we will present the full data set. We will have an investor event afterward.

Future pivotal trials? Thinking of a triplet in AML, exploring in expansion cohort. Planning a cohort in frontline setting.

Platform licensed to Lilly? Camptothecin payloads are designed to have potent anti-tumor activity. It gives us broad IP coverage. It should broaden the therapeutic window. We have good supporting data. Lilly is excited about the platform.

PFS with a single arm study like Soraya is not very meaningful, the FDA does not like to use it.

Is Gloriosa a confirmatory trial for Piccolo? Adding to mainenance bevacitinab vs. bev alone. Earlier data is promising, most platinum resistant patients have had a Parp. We hope for a long treatment duration on the mirv + bev arm, and could increase PFS and even have an OS advantage. Re Gloriosa + Piccolo, we need to talk to the FDA about a path to accelerated approval.

The data from Soraya is sufficient to support the approval of the diagnostic for FRa.

Doctors want to replace paclitaxil with our drug, largely because of less side effects.

Designed Gloriosa to support full approval for the mirv + bev combination.

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