Analyst Conference Summary

conference date: August 2, 2019 @ 5:00 AM Pacific Time
for quarter ending: June 30, 2019 (Q2, second quarter 2019)

Forward-looking statements

Overview: Plans to retest its lead candidate for ovarian cancer based on earlier test data. Has cash to do it.

Basic data (GAAP):

Revenue was $15.5 million, up 80% sequentially from $8.6 million, and up 67% from $9.3 million year-earlier. Revenue was largely non-cash.

Net income was negative $43.4 million, slightly up sequentially from negative $43.8 million, and down from negative $41.6 million year-earlier.

Diluted EPS was negative $0.29, up sequentially from negative $0.30, and down from negative $0.31 year-earlier.

Guidance:

Expects cash to last to first half of 2022, enough time to get critical mirvetuximab results.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "In the second quarter, we took important steps towards finalizing the design of the registration study for mirvetuximab soravtansine in folate receptor alpha (FRa)-high platinum-resistant ovarian cancer, prioritizing our portfolio of earlier-stage product candidates, and extending our cash runway with the completion of our operational review," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "Over the back half of 2019, we plan to meet with regulators regarding the final design of the registration study for mirvetuximab with the goal of initiating enrollment by end of year. Additionally, we look forward to presenting the full FORWARD I data and initial FORWARD II triplet data evaluating mirvetuximab in combination with carboplatin and Avastin (bevacizumab) at ESMO."

Immunogen is set to meet with the FDA to finalize the design of the Phase 3 trial for mirvetuximab soravtansine in folate receptor alpha (FRa)-high platinum-resistant ovarian cancer. This is a subset of the failed earlier trial, but it is a pre-specified subset that would have passed had management not tried to get a label including mid-FRa cancers. The trial could start by the end of 2019.

Immunogen has determined a recommended Phase 2 dose and schedule for IMGN632 and filed a protocol to support combination studies with Vidaza (azacitidine) and Venclexta (venetoclax), as well as evaluate single-agent safety and efficacy in acute myeloid leukemia (AML) patients with minimal residual disease (MRD+) following frontline induction therapy.

Immunogen presented mature data demonstrating significant anti-tumor activity, as well as safety and tolerability, from the FORWARD II expansion cohort evaluating mirvetuximab in combination with bevacizumab (Avastin) in patients with FRa-positive platinum-resistant ovarian cancer at the ASCO Meeting in June 2019.

Revenue by category: license and milestone $5 million; non-cash royalty revenue $10 million; R&D reimbursement $0.0 million; clinical materials $0.0 million.

Sale of residual rights to receive royalty payments on commercial sales of Kadcyla to the Ontario Municipal Employees Retirement System completed for $65 million.

Mirvetuximab soravtansine monotherapy for FRα-positive platinum-resistant ovarian cancer Phase 3 trial FORWARD I failed to hit endpoints, in Q1 2019, but data from the pre-specified subset of patients with high FRa expression suggest a favorable benefit-risk profile in this population.

Mirvetuximab soravtansine plus Avastin (bevacizumab) is in a Phase 2 trial, FORWARD II, continues to enroll patients, with that cohort to complete enrollment in Q3 2019. The cohort in ovarian cancer patients for whom a non-platinum-based regimen would be an appropriate next therapy started enrolling. This platinum agnostic population will include patients progressing after PARP inhibitor maintenance therapy, who represent an increasing share of the market. 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.

Because of its safety profile, Immunogen hopes to establish mirvetuximab as the choice for multi-drug therapies for ovarian cancer.

IMGN779 is in a Phase 1 trial for AML (acute myeloid leukemia), early cohort data was presented at ASH. 779 is differentiated from other agents targeting CD33 by its ability to alkylate DNA without cross-linking it. Nearing completion of enrollment in Q2 2019 and identifying a recommended Phase 2 dose.

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. Enrollment continues in Q2 2019. It is intended to treat "a range of hematological malignancies, including AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN).". Granted orphan drug designation. Data hopefully at ASH.

IMGC936, from the ADAM9 ADC program, in collaboration with Macrogenics is in IND enabling activity, with a submission planned in 2019.

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.

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

Cash and equivalents ended at $240 million, down sequentially from $na million. No debt, but lists Other long-term liabilities at $135 million.

Operating expenses were $57 million consisting of: $29 million R&D; $9 million general and administrative; restructuring $19 million. Loss from operations $41 million. Non-cash interest expense of on future royalty $4 million. Other income $1 million. No tax.

Q&A:

Kind of data we might see from Ritux + combo? ESMO forward I study will add key endpoints specified, plus some exploratory analysis that will inform the Phase 3 trial. Key endpoint was PFS, and secondary were ORR and OS.

Second Phase 3 ovarian cancer study changed? Much will be the same, 1 to 3 priors, FRa-high patients.

Monetization of lower-priority assets? It is an active process, we are seeing some inbound interest.

FRa-high label limitation for combinations? We are accruing both median and high level expressions for now. The data will determine the path to the combo labels.

Expenses going forward for Phase 3 trial? We are working on cost projections at this point. We will adjust the hazard ratio assumptions to reflect prior data.

Possible EMA review of Forward 1 study? Will meet in the fall for discussions about the Phase 3 protocol.

IMGN632? Two schedule 2-3 week and weekly, will share data at ASH if our abstract is accepted. For combinations we will need to do dose escalation studies. We don't have a timeline for a randomized trial yet. BPDCN indication is still being developed.

Physician interest in the new Phase 3 trial is overwhelming. Platinum resistant ovarian cancer has high unmet need, even with pipeline candidates.

Platinum sensitive setting? We hope to do combinations with platinum based therapies. We should have safety and efficacy data at ESMO.

Parp combo trial? It is investigator sponsored, they determine the timing.

IMGC936 responsibility is largely being transfered to Macrogenics.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: