Analyst Conference Summary


conference date: November 6, 2020 @ 5:00 AM Pacific Time
for quarter ending: September 30, 2020 (Q3, third quarter 2020)

I owned from 2016 to Dec. 17, 2019 and may buy again in the future.
Forward-looking statements

Overview: Continues to develop pipeline. In October raised cash through ATM and license agreement.

Basic data (GAAP):

Revenue was $18.2 million, up sequentially from $15.0 million, and up from $13.3 million year-earlier.

Net income was negative $22.4 million, up sequentially from negative $24.3 million, and down from negative $21.8 million year-earlier.

Diluted EPS was negative $0.13, up sequentially from negative $0.14, and up from negative $0.15 year-earlier.


For full year 2020 estimated revenues between $60 million and $65 million; operating expenses between $160 million and $165 million; and cash and equivalents at December 31, 2020 between $245 million and $250 million.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "At ESMO in September, we shared final data from our FORWARD II triplet cohort, which demonstrated the encouraging efficacy and favorable tolerability of mirvetuximab in combination with carboplatin and Avastin in FRa-positive recurrent, platinum-sensitive ovarian cancer. We are working to define the best path to label expansion for our combination regimens to benefit patients in earlier lines of therapy and establish mirvetuximab as the agent of choice to pair with other agents in ovarian cancer. On the regulatory front, we were pleased to receive FDA Breakthrough Therapy designation for IMGN632 in relapsed or refractory BPDCN, confirming the high unmet need for safe and effective therapies for this rare, aggressive cancer. We continue to advance multiple cohorts with IMGN632 and look forward to presenting updated monotherapy BPDCN expansion data in an oral presentation at ASH. Furthermore, we were pleased to enroll the first patient in our Phase 1 trial evaluating IMGC936, our ADAM9-targeting ADC in co-development with MacroGenics. Finally, we have further strengthened our balance sheet via our At-the-Market facility and business development activities and now expect to fund operations into the second half of 2022."

Imunogen entered into an exclusive collaboration to develop and commercialize mirvetuximab soravtansine in mainland China, Hong Kong, Macau, and Taiwan for an upfront payment of $40 million, with potential additional milestone payments of up to $265 million, as well as low double-digit to high teen royalties as a percentage of commercial sales.

Immunogen dosed the first patient in the Phase 3 trial (MIRASOL) for mirvetuximab soravtansine in folate receptor alpha (FRa)-high platinum-resistant ovarian cancer in Q1 2020. Top line data could be available in first half of 2022. Believes a sampling method for patients in the failed trial gave higher FRa than it should have, contributing to the failure by introducing low-FRa patients into a trial supposed to see treatment effects in high-FRa patients. In Q3 2020 mature data from the FORWARD II platinum-sensitive triplet cohort evaluating mirvetuximab in combination with carboplatin and Avastin were presented at ESMO.

The BLA for mirv is anticipated in 2H 2021, if trial results are positive.

In Q2 2020 initiated SORAYA, a new single-arm study in high-FRa platinum-resistant ovarian cancer for women previously treated with Avastin (bevacizumab), which is designed to support accelerated approval for mirvetuximab. Had received guidance from the FDA that SORAYA, could support accelerated approval for mirvetuximab with a BLA submission in the Q3 2021.

In Q3 2020 ImmunoGen sold an exclusive license to Viridian Therapeutics to develop and commercialize an insulin-like growth factor-1 receptor (IGF-1R) antibody for all non-oncology indications that do not use radiopharmaceuticals. Imunogen received an upfront payment, with the potential to receive additional development milestone payments of approximately $50 million and up to $95 million in sales milestone payments plus mid-single-digit royalties on the commercial sales of any resulting product.

IMGN632 Phase 1 for a AML is a CD123-targeting ADC with a DNA-alkylating payload. It is intended to treat "a range of hematological malignancies, including AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN).". Received Breakthrough Therapy designation from the FDA for in relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN). Continued IMGN632 monotherapy in Phase 1 expansion cohorts in patients with AML, BPDCN, relapsed acute lymphocytic leukemia (ALL), and minimal residual disease positive (MRD+) AML patients following frontline induction therapy. Abstract published for ASH for positive (ORR 30%) BPDCN data and AML. Advanced IMGN632 combination therapy studies with Vidaza (azacitidine) and Venclexta (venetoclax) in relapsed/refractory unfit AML patients.

IMGC936, from the ADAM9 ADC program, in collaboration with Macrogenics had its IND accepted by the FDA in Q2 2020 and enrolled its first patient in Q3 2020.

IMGN151 transitioned into preclinical development in Q2 2020. It also targets FRa. Immunogen presented compelling preclinical data for IMGN151 in ovarian cancer and other tumor types in a poster at the virtual American Association for Cancer Research (AACR) Annual Meeting. Could file an IND in 2H 2021.

A next generation anti-folate alpha (FRa) molecule is being readied for preclinical work.

Cash and equivalents ended at $188 million, down sequentially from $220 million. Other long-term liabilities at $2 million. In October 2020, the Company sold 12.9 million shares of its common stock through its ATM facility, of $54 million. Pursuant to a collaboration agreement executed with Huadong Medicine in October 2020, the Company received a $40 million upfront payment.

Operating expenses were $35 million consisting of: $25 million R&D; $10 million general and administrative. Loss from operations $17 million. Non-cash interest expense of on future royalty $6 million. Other income $0 million. No tax.

Q&A summary:

IMGN632 registration pathway? Pleased with activity seen in r/r BPDCN. We will meet with the FDA to determine a path forward and share that around the time of ASH.

IMGN632, how much more data might there be at ASH? We now have 9.2 month duration of response, which is quite nice. More at ASH.

Jazz Pharma opt in rights for 632? They have 2 opt in periods. First is up to initiation of pivotal development for AML. Second through BLA for AML. BPDCN has a deferal period if they have not opted in.

The Soraya data should be sufficient for the FDA, but they could want to wait for the Mirasol data.

To get a label expansion in earlier indications the most likely path is in some combination, as with Avastin.

IMGN632 has a very favorable safety and tolerability profile. Have not seen the capilary leak syndrome associated with other similar drugs.

Annual incidence of the market for our proposed ovarian cancer label would be 2,500 patients. If you take away the previously treated with Avastin criteria it jumps to about 5,000. Those are US numbers.

Could Soraya support EU approval? We will talk about the results with the EMA, but they are not keen on approving based on single arm studies. Mirasol could support full approval.

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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 2020 William P. Meyers