Analyst Conference Summary


conference date: November 3, 2017 @ 5:00 AM Pacific Time
for quarter ending: September 30, 2017 (third quarter 2017)

Forward-looking statements

Overview: greatly improved cash position and improved clinical pipeline.

Basic data (GAAP):

Revenue was $8.5 million, down 78% sequentially from $39.0 million, and up 10% from $7.7 million year-earlier. Does not include the $75 million received from Jazz in the quarter.

Net income was negative $57.7 million, down sequentially from negative $8.9 million, and down from negative $44.7 million year-earlier.

Diluted EPS was negative $0.61, down sequentially from negative $0.10, and down from negative $0.51 year-earlier.


At the end of 2017 cash and equivalents are expected between $260 and $265 million. Operating expense for 2017 reduced $5 million to $170 to $175 million.

Cash now expected to last until the fourth quarter of 2019.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "The Jazz collaboration accelerates the development of our early-stage programs in hematological malignancies, and the proceeds from this transaction and the October financing extend our operating runway well beyond the expected timeframe of the readout of FORWARD I, our Phase 3 registration study for mirvetuximab. We are continuing to advance FORWARD I along with our FORWARD II trial evaluating mirvetuximab in multiple combination regimens, and look forward to presenting data on IMGN779 and IMGN632 at the ASH Annual Meeting in December and opening the Phase 1 study for IMGN632 by year-end. Based on the progress made this year, we will enter 2018 with FORWARD I on track to complete enrollment by mid-year, clinical proof-of-concept for mirvetuximab's potential role as a combination therapy, two agents deploying our novel IGN payload in the clinic, and a strong balance sheet."

ImmunoGen made a collaboration and option agreement with Jazz Pharmaceuticals for IMGN779 and IMGN632, plus an additional future program. ImmunoGen received a $75 million fee.

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 $0.1 million; non-cash royalty revenue $6.5 million; R&D reimbursement $0.7 million; clinical materials $1.2 million.

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. Full enrollment in 2018. Futility only analysis in Q1 2018.

Mirvetuximab soravtansine plus Avastin is in a Phase 2 trial, FORWARD II. Another cohort is enrolling in combination with Keytruda. Will also have cohorts in combination with PLD, and with carboplatin.

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. Updated data should be presented at ASH.

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 should present preclinical data at ASH and open for enrollment by the end of 2017. 632 is a CD123-targeting ADC with a DNA-alkylating payload. The IND is now active.

Bayer is partnered on anetumab ravtansine for mesothelioma. Results were announced for the Phase 2 trial. See Anetumab Ravtansine Does Not Improve PFS vs. Vinorelbine. Despite lower PFS, there were less severe adverse events. Bayer is also studying the drug in other applications and in combinations.

Cash and equivalents ended at $194.9 million, up sequentially from $150.3 million. $30 million came from a Sanofi license fee, $75 million upfront from Jazz and $25 million upfront from Debiopharm, which became deferred revenue. In October, after the quarter ended, $101.6 million was raised with a commons stock offering and $96.9 million of debt was converted to common stock. Long-term liabilities were $169 million.

Operating expenses were $39.6 million consisting of: $31.7 million R&D; $7.9 million general and administrative. Loss from operations $31.1 million. Interest expense $0.8 million. Non-cash interest expense of on future royalty $3.4 million. Non-cash conversion expense $22.2 million. Other income $0.8 million. No tax.


779 at ASH? Data will be from all enrolled paitents. Initial data was at EHA. We have been increasing the dose level at every other week and added dosing once per week without any DLTs.

Cycle 2 death on 779? Adverse events? No deaths in R/R AML have been attributed to drug. As expected, there have been deaths related to infections, which is common in this population. Hepatotoxicity and elevated bilirubin (sp?), we have not seen any that is drug related.

Planned triple combination study, patients with prior PARP inhibitors? PARP can be effective in platinum-sensitive disease, but are difficult to combine because of their safety profile. Because of our mirv efficacy and tolerability, we have been able to combine with everything so far. "We believe the future is bright for a platinum-based triplet therapy with mirvetuximab and Avastin."

For the Avastin cohort we have already demonstrated pretty remarkable activity in a heavily pretreated population: 29% response rate and 9 month PFS. If those hold up in the expansion phase we could consider pivotal development. We would to see the Keytruda durability with the mirv response rate.

CD33 differentiation from competition? We have strong preclinical results, particularly in AML. We think we will win on the potency end, and better safety. We could add ALL as an expansion cohort, possibly other CD33 cancers.

Coltuximab CD19 interest in licensing has been tepid.

779 safety vs. Seattle Genetics failure? They saw a VOD signal and fatal infections. For VOD we are following patients closely, but not restricting eligibility with regard to transplants. The infections could have been from their known long white blood cell count suppression. So we are monitoring blood counts. In R/R patients are coming in with wiped out bone marrows. We don't believe our drug should result in prolonged myelosuppression.

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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