Analyst Conference Summary


conference date: May 3, 2019 @ 5:00 AM Pacific Time
for quarter ending: March 31, 2019 (Q1, first quarter 2019)

Forward-looking statements

Overview: Mirvetuximab soravtansine ovarian cancer trial failed to achieve the designated endpoints, but there still may be a pathway to registration. $270 million in cash to keep trying.

Basic data (GAAP):

Revenue was $8.6 million, up % sequentially from $na million, and down 57% from $19.8 million year-earlier. Revenue was largely non-cash.

Net income was negative $43.8 million, down sequentially from negative $40.8 million, and down from negative $38.6 million year-earlier.

Diluted EPS was negative $0.30, down sequentially from negative $0.28, and flat from negative $0.30 year-earlier.


Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "Following the readout of the top-line results from FORWARD I, we have undertaken a comprehensive analysis of the data and see a consistent efficacy signal across a range of parameters in the pre-specified subset of ovarian cancer patients with high folate receptor alpha (FRa) expression. Specifically, in comparison to chemotherapy, we have observed higher response rates, more durable responses, and longer progression-free and overall survival in patients with high FRa expression treated with mirvetuximab. With the benefit of this analysis and input from our clinical and regulatory advisors, we will be meeting with the FDA this quarter to discuss a potential path to registration for mirvetuximab as a monotherapy."

Revenue by category: license and milestone $0.1 million; non-cash royalty revenue $8.5 million; R&D reimbursement $0.0 million; clinical materials $0.0 million.

Sale of residual rights to receive royalty payments on commercial sales of Kadcyla to the Ontario Municipal Employees Retirement System completed for $65 million.

Mirvetuximab soravtansine monotherapy for FRα-positive platinum-resistant ovarian cancer Phase 3 trial FORWARD I failed to hit endpoints, in Q1 2019, but data from the pre-specified subset of patients with high FRa expression suggest a favorable benefit-risk profile in this population.

Mirvetuximab soravtansine plus Avastin is in a Phase 2 trial, FORWARD II, continues to enroll patients. 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. Positive data was updated at ESMO in October 2018. Reported "Favorable tolerability and encouraging anti-tumor activity" at ESMO, [but most analysts were not favorably impressed]. Will also have cohorts in combination with PLD, and with carboplatin. A cohort combination with Keytruda reported data at SGO in March showing an overall response rate of 63% and median progression free survival of 8.6 months. Cohort data release at ASCO in June was also positive with 7.8 months PFS.

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

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. Enrollment continues in Q2 2019. It is intended to treat "a range of hematological malignancies, including AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN).". Granted orphan drug designation.

IMGC936, from the ADAM9 ADC program, in collaboration with Macrogenics is in IND enabling activity, with a submission planned in 2019.

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.

Roche announced in October that its Phase 3 study met its primary endpoint showing that Kadcyla (trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death compared to Herceptin as an adjuvant treatment in people with HER2-positive early breast cancer who have residual disease present following neoadjuvant treatment.

Cash and equivalents ended at $ million, down sequentially from $262 million. No debt, but lists Other long-term liabilities at $ million.

Operating expenses were $50.2 million consisting of: $38.9 million R&D; $10.8 million general and administrative; restructuring $0.6 million. Loss from operations $41.6 million. Non-cash interest expense of on future royalty $3.4 million. Other income $1.4 million. No tax.


EU interactions for mirv? Those agencies have somewhat different approaches to circumstances like we find ourselves in. The have a conditional marketing authorization, so we are engaging with Europe, but it will have a longer timeline than with the FDA. They also look at the data differently. FDA accepts PFS for full approval, in EU they also want patient reported outcomes to support PFS. In this case the details will be important.

Survival event sense? Normally OS in platinum resistant ovarian cancer is 11 to 14 months. The data cut was in January 2019, just 9 months in. Many patients have not had the time to live past the median. But we had a reasonable number of events.

If FDA meeting is positive, what is the timeline? We could file the BLA before the end of year. Timing for a confirmatory study for full approval is harder to predict.

Expert feedback? They are impressed with the consistency of the signals seen in the high FRa subset, combined with the safety profile. We went head to head with chemo, but had less discontinuations.

Additional data? We now have PFS2, CF125, patient reports, subset analysis like type of prior therapy. The data is consistent with a high efficacy signal in the high FRa subgroup.

Will you have more mature data for the FDA? The data package to the FDA will facility the most productive discussion for a path forward?

The triplet data as ESMO will have some response rate data, but the patients do extremely well, so have not had time to get PFS or duration of resposne.

Experts see clinical relevance? Yes, this is the first monotherapy to show a survival benefit for this kind of patient.

Medium FRa group? In Phase 2 mediums looked like they did as well as chemo, with better safety. But in Phase 3 the high FRa people showed the most benefit, so we will now focus on them.

Prior FDA approvals of subgroups? Our subgroup was pre-specified, not found in a post-trial analysis. Believes there was one example with penatrexib (sp?).

Plans to start combination work with 632 this year.

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Disclaimer: My analyst call summaries may include both condensations of statements made by company representatives and my own analysis. They are not covered by any warranty. I cannot guarantee anything said by company representatives is true. I try not to make errors, but it is possible. These are my personal notes which I share with other investors and which I use as the basis of my Seeking Alpha articles.

Copyright 2019 William P. Meyers