Analyst Conference Summary

conference date: April 28, 2023 @ 5:00 AM Pacific Time
for quarter ending: March 31, 2023 (Q1, first quarter 2023)

Forward-looking statements

Overview: Elahere approved by the FDA for ovarian cancer in Q4; strong Q1 revenue.

Basic data (GAAP):

Revenue was $49.9 million, up 21% sequentially from $41.2 million, and up 31% from $38.1 million year-earlier.

Net income was negative $41.0 million, up sequentially from negative $59.0 million, and down from negative $24.1 million year-earlier.

Diluted EPS was negative $0.16, up sequentially from negative $0.23, and down from negative $0.10 year-earlier.

Guidance:

Believes funded into Q1 2025. For 2023 op ex between $320 and $335 million.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "With a strong first full quarter of sales and continued momentum in FRa testing and market access, we have started the year making great strides towards establishing Elahere as the standard of care for FRa-positive ovarian cancer. Our commercial and medical teams have delivered exemplary performances in the first stages of the Elahere launch and we look forward to continued success with the appointment of Isabel Kalofonos as our new Chief Commercial Officer. With our goal of obtaining full approval for Elahere in the US and expanding into Europe, we expect to announce top-line data from our confirmatory MIRASOL trial in early May. In parallel, we advanced our broader development program to move into platinum-sensitive disease and position Elahere as the combination agent of choice in ovarian cancer." Will provide Elahere revenue guidance after another quarter of experience.

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 from Elahere was $29.5 million product sales. $15.0 million was from license and milestones (from Vertex); $4.8 million was non-cash royalties; $0.5 million was from research support.

Expects to report top-line Mirasol trial data for Elehere in early May, 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.

In Q2 Immunogen announced a new non-dilutive credit facility with Pharmakon Advisors, LP for up to $175 million; $75 million was received upon execution, in Q2.

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, with enrollment completion expected by year-end 2023.

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 enrolled its first Phase 1 patient in January 2023 and continues dose escalation.

Cash and equivalents ended at $201 million, down sequentially from $275 million. No long-term debt.

Operating expenses were $92.3 million consisting of: cost of sales $0.6 million; $51.6 million R&D; $40.0 million general and administrative. Income from operations negative $42.4 million. Non-cash interest expense of on future royalty $1 million. Other income $2.3 million. Income tax $0 million.

Q&A selective summary:

Mirasol topline data? Will have PFS plus secondary of overall survival.

Elahere use with Avastin off label? We have data for less than 100 patients. But we are seeing some combination therapy use.

Repeat orders? We see a significant percentage of repeat orders, but it is too early to draw conclusions. So no sense at this point of duration of therapy.

Payer adoption has been rapid. Comparison to chemo is strong for both safety and efficacy. Still learning about the market, but there are still growth drivers, like testing rates. Market size is still somewhat unknown because of lack of testing for FRA.

April? We see continued growth of the product.

When the first debulking surgery is done, other tests are run, so adding FRA testing makes sense.

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