Analyst Conference Summary

conference date: February 8, 2019 @ 5:00 AM Pacific Time
for quarter ending: December 31, 2018 (Q4, fourth quarter 2018)

Forward-looking statements

Overview: Waiting for results for mirvetuximab soravtansine in ovarian cancer.

Basic data (GAAP):

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

Net income was negative $40.8 million, up sequentially from negative $48.7 million, but down from negative $13.1 million year-earlier.

Diluted EPS was negative $0.28, up sequentially from negative $0.32, but down from negative $0.11 year-earlier.

Guidance:

For 2019, ImmunoGen expects cash and cash equivalents at December 31, 2019 to be between $135 million and $140 million; revenues between $40 million and $45 million; and operating expenses between $265 and $270 million. Current cash combined with the expected cash receipts should enable the Company to fund its operations at least a year beyond the release of top-line results from the Phase 3 FORWARD I trial, expected in the first half of 2019.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "We generated significant momentum in the business during 2018, led by the completion of enrollment in FORWARD I, our registration study for mirvetuximab soravtansine in platinum-resistant ovarian cancer; the publication of combination data in over 100 patients to support label expansion; and the advancement of our earlier-stage portfolio. On the strength of this performance, we enter 2019 poised to deliver on a number of important catalysts for the company, including top-line results from FORWARD I in the first half of the year, the potential BLA and MAA submissions for mirvetuximab monotherapy in the second half of the year, and additional combination data from our triplet in platinum-sensitive disease. Beyond our lead program, we expect to report data from expansion studies in AML and BPDCN with our programs targeting hematological malignancies and to file an IND before year-end for IMGC936, an ADAM9-targeting ADC being developed in collaboration with MacroGenics. Finally, with the benefit of the sale of the Kadcyla royalty tail, we start the year with roughly $325 million on the balance sheet to support our development and pre-commercial activities as we transition to a fully-integrated company."

Revenue by category: license and milestone $1.7 million; non-cash royalty revenue $9.7 million; R&D reimbursement $0.2 million; clinical materials $2.2 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 positive 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 was presented at ASH. 779 is differentiated from other agents targeting CD33 by its ability to alkylate DNA without cross-linking it. Still enrolling 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 initial data was presented at ASH; characterized as encouraging. 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 is in 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 $262 million, down sequentially from $303 million. No debt, but lists Other long-term liabilities at $133 million.

Operating expenses were $53 million consisting of: $43 million R&D; $10 million general and administrative; restructuring $0.4 million. Loss from operations $39 million. Non-cash interest expense of on future royalty $2 million. Other income $1 million. No tax.

Q&A:

Mirvetuximab + Pembrolizumab October data maturation? We are following that cohort, may have more data later this year.

Peg-doxorubicin is the most common therapy for platinum-resistant ovarian cancer, second most common is paclitaxel.

Droppout rate? Has been consistent with expectations.

No statement about whether we have hit the target number of events.

We clean data throughout the course of the trial. There is an increased focus towards the end of the trial. It has no implications for results timing.

Our confidence in our control are has increased since we started the trial, based on some other trial readouts.

About 40% of platinum-resistant ovarian cancer patietns have high FRα, about 20% medium, and 40% low. But in the trial we expect a majority to be high.

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