Analyst Conference Summary

ImmunoGen
IMGN

conference date: May 5, 2017 @ 5:00 AM Pacific Time
for quarter ending: March 31, 2017 (first quarter 2017)


Forward-looking statements

Overview: Has a good shot at another commercial approval in 2020, but will run out of current cash before then.

Basic data (GAAP):

Revenue was $28.7 million, up sequentially from $13.8 million, but up from $19.7 million year-earlier.

Net income was negative $17.3 million, up sequentially from negative $34.2 million, and up from negative $31.9 million year-earlier.

Diluted EPS was negative $0.20, up sequentially from negative $0.39, and down from negative $0.37 year-earlier.

Guidance:

No change. Cash should last into Q2 2018.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "Following enrollment of our first patient in FORWARD I in January, we have since expanded the study to include additional centers in North America and Europe, and expect to activate more than 100 sites in these geographies before the end of the year. We presented data at the SGO Annual Meeting supporting our patient selection strategy for FORWARD I and delivered nine presentations at the AACR Annual Meeting highlighting novel ADCs and enhancements to our platform technologies. For the remainder of the year, we look forward to a number of additional milestones, including sharing new efficacy and safety data for mirvetuximab soravtansine at ASCO and filing an IND for our CD123-targeting ADC, IMGN632, in the third quarter."

First revenue from mirvetuximab soravtansine is possible in 2020. Obtained agreements with the FDA and EMA supporting full approval with a positive FORWARD I trial.

Revenue by category: license and milestone $18.7 million; non-cash royalty revenue $7.6 million; R&D reimbursement $1.7 million; clinical materials $0.7 thousand.

Mirvetuximab soravtansine for FRα-positive platinum-resistant ovarian cancer Phase 3 trial FORWARD I enrolled its first patient in January. PFS (progression free survival) will be the primary endpoint. There will be 333 patients with high or medium FRα levels randomized 2:1 against physician's choice of single agent chemotherapy. Patients can have been treated with up to 3 prior therapies. Enrollment is going well. More data will be presented at ASCO in June.

Mirvetuximab soravtansine plus Avastin is in a Phase 2 trial, FORWARD II. Will also have cohorts in combination with PLD, carboplatin, and Keytruda. Initial 1b/2 data will be presented in Q2 2017.

IMGN779 is in a Phase 1 trial for AML (acute myeloid leukemia). 779 is differentiated from other agents targeting CD33 by its ability to alkylate DNA without cross-linking it. Preclinical data was presented at ASH in December. Phase 1 data should be reported in mid 2017.

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

IMGN632 preclinical data was presented at ASH in December. Phase 1 for a AML should start in 2017, following the IND submission in Q3 2017 and approval.

Bayer completed enrollment of its Phase 2 registration trial of anetumab ravtanzine for mesothelioma.

"Takeda initiated preclinical development with the first ADC using ImmunoGen's IGN platform directed to a solid tumor."

ImmunoGen expects to advance the first candidate under its collaboration with CytomX into preclinical development in 2017.

Believes that new payloads, linkers, and antibodies will allow more types of cancer to be treated.

Cash and equivalents ended at $127 million, down $33 million sequentially from $160 million. Long-term liabilities were $100 million in convertible debt and $190 million, mostly long-term deferred revenue from Kadcyla future royalty deal.

Operating expenses were $41.6 million consisting of: $33.1 million R&D; $8.1 million general and administrative; $0.4 million restructuring. Loss from operations $12.9 million. Non-cash interest expense of on future royalty $3.6 million. Interest on convertible bonds $1.1 million. Other income $0.2 million. No tax.

Q&A:

Mirvetuximab ASCO presentations? One will be a pooled data set aggregating the totality of our patients in Phase 1b. The other is the combination cohorts. When the abstracts are released we will provide more detail.

Capital, business development? Everything is dilutive at some level. We have active interest in our B-cell programs for out-licensing. We already have agreements for downstream royalties. We are also looking at partnering more early-stage programs.

AML (779) program? We are differentiated by a higher level of tolerability. Our payload modifies one strand of dna, it does not crosslink. Preclinical, we say the same level of potency as payloads such as Seattle's. So we can dose more frequently. Of course we are monitoring patients for the problems seen in the competing drugs.

FORWARD 1 timeline? Futility analysis in early 2018 and results in 2019. No change there.

So far the FORWARD II trials are showing good safety, minimum side effects for the combinations. We are confident we can do a full dose of Mirvetuximab with full doses of the other nations. "So far so good."

779 data mid year? Preclinical and dose escalation Phase 1. We are still in dose escalation.

Ovarian cancer landscape given PARP inhibitor approvals? Our target is platinum resistant disease. Standard of care is chemo or Avastin. Mirvetuximab is well-positioned as a single agent in the resistant setting, and may do well in combination. PARP in platinum resistant even in BRCM is underwhelming, about the same as chemotherapy. PARP inhibitors did well in the non-resistant setting. We will have a combination trial with Mirvetuximab combined with a PARP inhibitors.

Investigator trial in triple-negative breast cancer of Mirvetuximab? Rational is FRα is frequently overexpressed in this cancer. These NCCN studies will have quick readouts.

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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 blog and Seeking Alpha articles.

Copyright 2017 William P. Meyers