Analyst Conference Summary


conference date: July 28, 2017 @ 5:00 AM Pacific Time
for quarter ending: June 30, 2017 (second quarter 2017)

Forward-looking statements

Overview: Released data supporting further clinical development.

Basic data (GAAP):

Revenue was $39.0 million, up 36% sequentially from $28.7 million, and 427% from $7.4 million year-earlier.

Net income was negative $8.9 million, up sequentially from negative $17.3 million, and up from negative $45.9 million year-earlier.

Diluted EPS was negative $0.10, up sequentially from negative $0.20, and down from negative $0.53 year-earlier.


Updated. Revenue is expected between $115 and $120 million. Cash at end of year should be between $90 and $95 as a result of the Debiopharm and Sanofi agreements. Operating expenses unchanged at $175 to $180 million. Believes has cash to last into the second half of 2018.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "We reported single-agent and combination therapy data with mirvetuximab soravtansine in over 150 patients at ASCO, which strengthen our confidence in the potential of mirvetuximab in the FORWARD I patient population and as we move into earlier lines of treatment for ovarian cancer. In addition, we presented encouraging initial clinical results for IMGN779 in AML, demonstrating dose-dependent biological and anti-leukemia activity, and the ability to retreat patients. Lastly, we significantly improved our cash position through transactions with Sanofi and Debiopharm, enabling us to increase our focus on the development of mirvetuximab and our IGN programs. We look forward to continued execution on these programs over the back half of the year, including filing the IND for IMGN632, our novel CD123-targeting ADC for hematological malignancies."

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.

ImmunoGen licensed a set of ADC agents to Sanofi for $30 million.

Debiopharm paid $25 million for IMGN529, an anti-CD37 ADC for B-cell malignancies. Further milestone payments are possible.

Bayer's Phase 2 trail of anetumab ravtansine for mesothelioma did not meat its primary endpoint, but other trials in other cancers continue.

Revenue by category: license and milestone $31.1 million; non-cash royalty revenue $6.4 million; R&D reimbursement $0.9 million; clinical materials $0.6 million. this included a $30 million license fee from Sanofi.

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. Positive data from earlier trials, including in combination with Avastin, Doxil, or Keytruda, was 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 was presented:

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. Positive Phase 1 data was presented at EHA showing safety and dose-dependent activity.

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.

ImmunoGen received a $1 million payment following the initial treatment of a patient with CX-2009 by CytomX.

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

Cash and equivalents ended at $150.3 million, up sequentially from $127 million. Long-term liabilities were $287 million in convertible debt and deferred revenue from Kadcyla future royalty deal.

Operating expenses were $44.2 million consisting of: $35.3 million R&D; $8.8 million general and administrative. Loss from operations $5.1 million. Non-cash interest expense of on future royalty $3.5 million. Interest on convertible bonds $1.1 million. Other income $0.9 million. No tax.


Mirvetuximab? The 65% response rate and progression free survival was quite. Could do as a doublet or triplet in earlier lines of therapy.

AML? Landscape has changed for AML, so 779 plans may change. Seattle Genetics stopped its development. We had planned to develop 779 around them, now have a more open field. Event free survival can now be a primary endpoint for first line AML, which could mean a shorter Phase 3 trial.

779, AML segments, any population you want to focus on? CD33 is expressed in most AML. So we see it as beneficial for almost all AML patients, where as other drugs are more targeted. We have seen the ability to repeat 779 dosing, we have a good tolerability profile, which could help in combinations, but for now we are prioritizing monotherapy.

Why is this not a CD33 issue given the Seattle Genetics failure? The differentiator was to eliminate toxicity from cross-linking ADCs, blade toxicity and bone marrow repression. The data at ASH last year compared cross linking to our differentiated technology that only attacks one strand of DNA. The target is the same. Mylotarg has shown CD33 is a viable target.

779 toxicity profile, alkalator vs. cross linking? With equivalent doses, 10 to 20 days after administration you see a decline in weight, we don't see that with ours. Early toxicity is similar between the two drugs.

Forward I futility analysis? We are on track for first half of 2018, after 80 PFS events. If the hazard ratio is greater than one, then we would stop.

Merck triple negative breast cancer trials? The percent that express FRα is lower than ovarian, but still high enough to pursue.

Mylotarg return to market? Their label is for 7 + 3 in frontline AML, it seems to benefit the good risk patients. We can address the first-line unfit patients. We will have to see where Mylotarg will land.

We are seeing external interest in our platform and candidates. For Mirvetuximab it would have to be a pretty good offer for that program.

Bayer collaboration, other milestones other than the failed indication? There are 1b studies in multiple tumor types including platinum resistant ovarian cancer. The next milestone would be commencement of pivotal testing in another indication. Mesothelioma is a notoriously difficult to treat tumor type, and there had been some hopeful data.

Mirv combinations timelines? Three of the combinations had data shown at ASH. Keytruda initial efficacy data should come next year. First half of 2018 for more data on the others as well.

Forward I primary endpoint, types of population? About 80% of ovarian cancers are FRα. 40 20 40 High Medium Low expression in typical populations. About 2/3 of our subjects will be high, the rest medium. Generally the higher the expression, the greater the benefit, so far.

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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