Analyst Conference Summary

conference date: March 1, 2023 @ 5:00 AM Pacific Time
for quarter ending: December 31, 2022 (Q4, fourth quarter 2022)

Forward-looking statements

Overview: Elahere approved by the FDA for ovarian cancer.

Basic data (GAAP):

Revenue was $41.2 million, up sequentially from $15.4 million, and up 47% from $28.0 million year-earlier.

Net income was negative $59.0 million, up sequentially from negative $77.8 million, and down from negative $37.2 million year-earlier.

Diluted EPS was negative $0.23, up sequentially from negative $0.31, and down from negative $0.17 year-earlier.

Guidance:

Believes funded into Q1 2024. Revenue for 2023 expected between $30 and $35 million, excluding potential Elahere revenue. Op Ex between $310 and $320 million.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "We have seen broad and deep adoption of Elahere to date, with FRa testing, managed care coverage, and provider access all exceeding our expectations. Building upon this progress and in line with our goal of obtaining full approval for Elahere in the US and expanding into Europe, we will imminently reach the requisite number of PFS events in the confirmatory MIRASOL trial and expect to announce top-line data in the second quarter. In parallel, we are pursuing our broader development program in support of moving Elahere into platinum-sensitive disease and positioning Elahere as the combination agent of choice in ovarian cancer."

On November 14, 2022, the FDA approved Elahere (mirvetuximab soravtansine-gynx) for platinum-resistant ovarian cancer. Expects top-line Mirasol trial results in Q2 2023, which should support full FDA approval as well as an EU application in 2H 2023. Partner Huadong Medicine will apply in China. Early adoption is going well.

Revenue was $2.6 million product sales. $30.8 million was from license and milestones; $7.7 million was non-cash royalties; $0.1 million was from research support. The Elahere revenue was all from December. Revenue growth accelerated in 2023.

On March 1, 2023, Immunogen announced a global, multi-target license and option agreement granting Vertex Pharmaceuticals (VRTX) rights to conduct research using ImmunoGen's ADC technology to discover novel targeted conditioning agents for use with gene editing. Will receive a $15 million upfront payment and up to $337 million in potential option exercise fees, development and commercial milestones, plus tiered royalties, all on a per target basis.

Positive data from expansion cohorts in the Phase 1b/2 study evaluating the pivekimab sunirine (pivekimab) triplet with Vidaza (azacitidine) and Venclexta (venetoclax) in relapsed/refractory and in frontline unfit acute myeloid leukemia was presented in an oral presentation at the 2022 ASH meeting in December 2022. Included a 50% response rate. The pivotal Phase 2 CADENZA study of pivekimab in frontline and relapsed/refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN) continues.

Immunogen announced a clinical collaboration with Gilead (GILD) to evaluate the safety and activity of pivekimab in combination with magrolimab, a potential first-in-class CD47 inhibitor, in patients with R/R CD123-positive AML.

Imunogen completed dose escalation in the Phase 1 study of IMGC936 in multiple solid tumor types in 2022. Has initiated expansion cohorts in triple-negative breast cancer and non-small cell long cancer. Data will be shared in Q2 2023.

In Q1 2023 completed enrollemnt in PICCOLO, a single-arm study of mirvetuximab monotherapy in high FRa recurrent platinum-sensitive ovarian cancer, designed to support potential label expansion.

IMGN151, a next generation anti-folate alpha (FRa) molecule made enrolled its first Phase 1 patient in January 2023.

Cash and equivalents ended at $275 million, down sequentially from $309 million. Other long-term liabilities at $35 million.

Operating expenses were $101 million consisting of: cost of sales $0.2 million; $58 million R&D; $42 million general and administrative. Income from operations negative $60 million. Non-cash interest expense of on future royalty $1 million. Other income $3 million. Income tax $1 million.

Q&A selective summary:

Elahere launch, combination with Avastin? We don't have that data yet. Should have a better idea next quarter.

Picolo data, regulatory bar? Recurrent, platinum-sensative, later line patients, there is not a clear bar. This is an evolving unmet need, patients have had a PARP inhibitor as maintenance. We will need to engage with the FDA.

In Q2 we should be sharing triple-negative breast cancer data, but might hold off on lung cancer, to see more data.

There are reasons physicians are testing for FRa early, they are becoming used to testing cancers for variations early in the course of the disease.

Any testing bottleneck? None. All four central labs are working well.

We did have a lot of testing early on as we had a backlog of patients who were platinum resistant and looking at moving to therapy.

Vertex agreement? Cannot comment on the targets. Is in conjuction with their gene editing program.

We are evaluating various measures for raising cash, including dividend financing, stock offerings, and perhaps even debt.

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