Analyst Conference Summary

conference date: February 14, 2020 @ 5:00 AM Pacific Time
for quarter ending: December 31, 2020 (Q4, fourth quarter 2020)

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

Overview: First patient enrolled in the confirmatory ovarian cancer trial. Higher than usual revenue due to timing of milestone payments.

Basic data (GAAP):

Revenue was $44.9 million, up sequentially from $13.3 million, and up from $13.4 million year-earlier.

Net income was $4.8 million, up sequentially from negative $21.8 million, and up from negative $41.8 million year-earlier.

Diluted EPS was $0.03, up sequentially from negative $0.15, and up from negative $0.28 year-earlier.

Guidance:

For the full year 2020 ImmunoGen expects revenues between $60 million and $65 million; operating expenses between $165 million and $170 million; and end-of-year cash between $170 million and $175 million.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "We have enrolled the first patient in the confirmatory MIRASOL Phase 3 trial for mirvetuximab, presented clinical data at ASH in December demonstrating IMGN632's encouraging anti-tumor activity and favorable tolerability in patients with AML and BPDCN, and, most recently, raised roughly $98 million in a follow-on offering to strengthen our balance sheet. We enter 2020 with a number of important upcoming milestones to drive value in the business. For mirvetuximab, these include opening our pivotal SORAYA trial in the first quarter, continuing to enroll MIRASOL, initiating an additional combination study in platinum-sensitive disease, and presenting data from our platinum-agnostic and platinum-sensitive combination studies. Building upon the encouraging data we reported in 2019, we will continue to advance IMGN632 in the clinic and look forward to presenting BPDCN and MRD+ monotherapy and AML combination data this year. In addition, we expect the IND for IMGC936, our novel ADAM9-targeting ADC, to be filed during the first half of the year."

Immunogen dosed the first 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 2022. In addition received guidance from the FDA that SORAYA, a new single-arm study in platinum-resistant ovarian cancer, could support accelerated approval for mirvetuximab with a BLA submission in the second half of 2021.

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.

Immunogen has determined a recommended Phase 2 dose and schedule for IMGN632 and filed a protocol to support combination studies with Vidaza (azacitidine) and Venclexta (venetoclax), as well as evaluate single-agent safety and efficacy in acute myeloid leukemia (AML) patients with minimal residual disease (MRD+) following frontline induction therapy. Data will be presented at ASH in December.

Revenue by category: license and milestone $29.5 million; non-cash royalty revenue $15.3 million; R&D reimbursement $0.0 million; clinical materials $0.0 million.

Mirvetuximab soravtansine plus Avastin (bevacizumab) completed enrollment in a Phase 2 trial, FORWARD II. The cohort in ovarian cancer patients for whom a non-platinum-based regimen would be an appropriate next therapy started enrolling. This platinum agnostic population will include patients progressing after PARP inhibitor maintenance therapy, who represent an increasing share of the market. Cohort data release at ASCO in June was positive with 7.8 months PFS.

Because of its safety profile, Immunogen hopes to establish mirvetuximab as the choice for multi-drug therapies for platinum-sensitive ovarian cancer.

In Q4 2020 ImmunoGen licensed the epithelial cell adhesion molecule (EpCAM)-targeting Probody-drug conjugate to CytomX in exchange for an upfront fee and milestone and royalty payments.

IMGN779 is in a Phase 1 trial for AML (acute myeloid leukemia), early cohort data was presented at ASH. 779 is differentiated from other agents targeting CD33 by its ability to alkylate DNA without cross-linking it. Nearing completion of enrollment in Q2 2019 and identifying a recommended Phase 2 dose.

IMGN529 is in a Phase 2 trial for DLBCL (diffuse large B-cell lymphoma). It has orphan drug designation.

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. Data presented at ASH in December 2019. 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

ImmunoGen presented preclinical data for an epithelial cell adhesion molecule (EpCAM)-targeting Probody drug conjugate (PDC) at the European Antibody Congress in October. The EpCAM-targeting PDC integrates the Probody technology developed by CytomX.

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

Cash and equivalents ended at $176 million, down sequentially from $205 million. Other long-term liabilities at $107 million. After the quarter ended, in January 2020 raised $98 million in a follow-on stock offering. Believes cash could last through first approval of mirv.

Operating expenses were $36 million consisting of: $26 million R&D; $10 million general and administrative; restructuring $0.5 million. Income from operations $8.5 million. Non-cash interest expense of on future royalty $5 million. Other income $2 million. No tax.

Q&A summary:

Number of patients in FORWARD II doublet? 60 patients, some will have received prior Avastin.

SORAYA trial prior Avastin? Usually only 1 course of Avastin, if they get it at all.

FORWARD II triplet? Will have more triplet data at ESMO. Other triplets typically 12 to 14 month PFS. But would require a large, long trial.

IMGC936 ADAM9 stratification? We will assess ADAM9 levels. Pancretic, gastric, lung, and triple-negative breast will be the first targets.

After restructuring, with SORAYA we have added a very few heads.

Checkpoint inhibitors have not really moved the needle in ovarian cancer. We have not see very many patients with prior checkpoint inhbitors in our trials. Do not expect it to impact Mirv activity.

911 difference from Mirv? New linker and probe and antibody.

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