Analyst Conference Summary


conference date: November 2, 2018 @ 5:00 AM Pacific Time
for quarter ending: September 30, 2018 (Q3, third quarter 2018)

Forward-looking statements

Overview: Initiated the activities required to support a FDA filing and launch mirvetuximab soravtansine in ovarian cancer.

Basic data (GAAP):

Revenue was $10.9 million, up 17% sequentially from $9.3 million, and up 28% from $8.5 million year-earlier. Revenue was largely non-cash.

Net income was negative $48.7 million, down sequentially from negative $41.6 million, but up from negative $56.7 million year-earlier.

Diluted EPS was negative $0.32, down sequentially from negative $0.31, up from negative $0.61 year-earlier. Sharecount was 147 million, up 58% from 93 million year-earlier.


Will end 2018 with cash between $250 and $255 million.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "With the completion of enrollment in FORWARD I, we have initiated the activities required to support a BLA filing and launch mirvetuximab soravtansine in ovarian cancer. Over the last three months, we have completed the product validation runs for drug substance, put in place operational metrics and resources to ensure timely assessment of the primary endpoint for the study, and moved ahead with pre-launch commercial planning. In parallel, we continued to execute across the remainder of the business, including presentation of initial data from the FORWARD II KEYTRUDA combination at ESMO, accelerating accrual in the FORWARD II triplet cohort, and advancing our next ADC into preclinical development in collaboration with MacroGenics. Looking ahead to the fourth quarter and the coming year, with a strong cash runway, we are well-positioned to deliver on our strategic priorities and look forward to oral presentations for our novel IGN assets, IMGN779 and IMGN632, at ASH in December and to announcing top-line results from FORWARD I during the first half of 2019."

Revenue by category: license and milestone $0.7 million; non-cash royalty revenue $8.4 million; R&D reimbursement $0.4 million; clinical materials $1.4 million.

Mirvetuximab soravtansine for FRα-positive platinum-resistant ovarian cancer Phase 3 trial FORWARD I has completed enrollment and should report top line results in the first half of 2019. Received FDA fast-track designation. First revenue from mirvetuximab soravtansine is possible in 2020. Has agreements with the FDA and EMA supporting full approval with a positive FORWARD I trial, with PFS as the primary endpoint. "We believe mirvetuximab has the potential to replace chemotherapy in the FRα-positive platinum-resistant ovarian cancer segment."

Mirvetuximab soravtansine plus Avastin is in a Phase 2 trial, FORWARD II, with data updated at ESMO in October. Cohort enrollment completion by end of 2018 with data mid-2019. 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. An expansion cohort is being enrolled.

IMGN779 is in a Phase 1 trial for AML (acute myeloid leukemia), data to be presented at ASH. 779 is differentiated from other agents targeting CD33 by its ability to alkylate DNA without cross-linking it. Updated data was presented at ASH. Also looking to possible combination studies.

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 initial data to be presented at ASH. It is intended to treat "a range of hematological malignancies, including AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN).". Granted orphan drug designation.

ADAM9 ADC program, in collaboration with Macrogenics, taken to IND enabling activity.

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 $303 million, down sequentially from $345 million. No debt, but lists Other long-term liabilities at $222 million.

Operating expenses were $ million consisting of: $47.2 million R&D; $8.3 million general and administrative; restructuring $0.9 million. Loss from operations $45.5 million. Non-cash interest expense of on future royalty $2.5 million. Other income $1.3 million. No tax.


IMGN632 dose response? 12 patients over 4 cohorts, 4 objective responses. Detailed data will be presented at ASH. Both studies (779 & 632) are still enrolling, so there will be more data at ASH than is in the abstracts.

AML strategy with two agents? 779 and 632 both encouraging, will consider combination strategies with our partner Jazz.

Competition for CD123 target is CART and bi-specifics. We are the only ADC. Each has its strengths, but CART and bi require healthier patients. Our drug could be given on an outpatient basis.

Next Avastin combo cohort? In previously treated patients. It is becoming more difficult to pin down who is platinum resistant, because of PARP therapies, so our next cohort will have looser criteria.

Moving into the platinum-sensative place would likely require a triplet.

Prior avastin? We already had some prior avastin patients in a cohort, it does not seem to matter, so we are allowing them to enroll in the new cohort.

779 is still in dose escalation, data will be shared at ASH.

We are making commercial preparations mainly in manufacturing and planning. If we get a positive readout we would hire a manager for the launch. It will involve an increase in spend, which is included in the cash runway we have stated.

Tumor shrinkage v. durability data? Avastin may be adding durability. Mirv is much more tolerable than paclitaxel. With checkpoint inhibitors there is a tail to the curve, but can't predict which patients will be durable. Checkpoint inhibitors have not achieved proof of concept for ovarian cancer. We have incorporated tumor biopsies in our Keytruda plan.

The Keytruda combo study required 2 prior lines of therapy, and included much more pretreated patients than in our earlier mirv study, yet showed a good response.

We would not be able to start 3 pivotal combination trials at once, so we will be looking at the data and prioritizing.

OpenIcon Analyst Conference Summaries Main Page



More Analyst Conference Pages:


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 2018 William P. Meyers