Analyst Conference Summary

conference date: February 12, 2021 @ 5:00 AM Pacific Time
for quarter ending: December 31, 2020 (Q4, fourth quarter 2020)

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

Overview: Expects Mirvetuximab ovarian cancer data in Q3, with BLA to FDA by year end. Believes has 2 potential commercial launches for 2022.

Basic data (GAAP):

Revenue was $86 million, up sequentially from $18.2 million, and up from $45 million year-earlier.

Net income was $31 million, up sequentially from negative $24.4 million, and down from $5 million year-earlier.

Diluted EPS was $0.16, up sequentially from negative $0.13, and up from $0.03 year-earlier.

Guidance:

2021 revenue expected between $65 and $75 million. Op ex $200 to $210 million. Cash at end of year between $140 and $150 million.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "Within our portfolio, we advanced accrual in the pivotal SORAYA and confirmatory MIRASOL trials for mirvetuximab soravtansine in patients with ovarian cancer to support our projected timelines for top-line data and regulatory submissions. In addition, we established a second registration program with our CD123-targeting ADC, IMGN632, for which we received Breakthrough Therapy designation and aligned with FDA on a path to full approval in BPDCN. Furthermore, we began dosing patients in the Phase 1 study of IMGC936, our first-in-class ADAM9-targeting ADC for solid tumors, and transitioned IMGN151, our next-generation FRa-targeting ADC, into preclinical development. Finally, through a combination of business development and activity under our ATM facility, we added over $140 million to our balance sheet in the fourth quarter."

Revenue was mainly from upfront payments and collaborations.

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.

In Q3 2020 positive mature data from the FORWARD II platinum-sensitive triplet cohort evaluating mirvetuximab in combination with carboplatin and Avastin were presented at ESMO. Plans to present again at ASCO 2021.

The BLA for mirvetuximab for ovarian cancer is anticipated in Q4 2021, if Soraya trial results are positive when released in Q3.

Patient accrual continued in the Phase 1 dose-escalation study evaluating IMGC936, our novel ADAM9-targeting ADC in co-development with MacroGenics.

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 1/2 for a AML is a CD123-targeting ADC with a DNA-alkylating payload. As of Q1 2021 is aligned with FDA on path to full approval with cohort of up to 20 frontine blastic plasmacytoid dendritic cell neoplams patients. 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.

IMGN151, a next generation anti-folate alpha (FRa) molecule, began preclinical development in Q4 2020. An IND submission is expected by year-end 2020.

Cash and equivalents ended at $294 million, down sequentially from $188 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 $49 million consisting of: $40 million R&D; $10 million general and administrative. Income from operations $37 million. Non-cash interest expense of on future royalty $6 million. Other income $1 million. No tax.

Q&A summary:

Compendia listing for Mirv combinations? We would file for listings almost immediately. The requirement is for two peer reviewed publications.

Efficacy bar in platinum agnostic ? For mirv 64% response for platinum resistent, high 60s for platinum sensitive. Both better than standard of care, more like 27% to 28% for resistant, 50s for sensitive.

May need as few as 13 BPDCN patients to get approval.

Competition with BPDCN? Will compete of efficacy, safety, and convenience. We believe data are in our favor compared to Elzonris.

Launch prep? Mainly doing market research, patient numbers, payer mix. Could use outside support if we get a positive Soraya readout.

Risk FDA will want to see Mirosol results first? We expect if Soraya data meets criteria for accelerated approval there is no basis for the FDA to delay action. But the EU will probably require the Mirosol data.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: