ImmunoGen
IMGN
conference date: May 4, 2018 @ 5:00 AM Pacific Time
for quarter ending: March 31, 2018 (Q1, first quarter 2018)
Forward-looking
statements
Overview: Waiting on important data to be released in 2019.
Basic data (GAAP):
Revenue was $19.8 million, down sequentially from $39.4 million, and down from $28.5 million year-earlier.
Net income was negative $38.6 million, down sequentially from negative $13.1 million, and down from negative $17.3 million year-earlier.
Diluted EPS was negative $0.30, down sequentially from negative $0.11, and down from negative $0.20 year-earlier.
Guidance:
2018 operating expenses are expected between $200 and $205 million. Revenue between $60 and $65 million. Cash an equivalents at end of year between $115 and $120 million.
Conference Highlights:
Mark Enyedy, CEO of ImmunoGen, said "Our FORWARD I registration trial continues as planned following the successful outcome of the pre-specified interim futility analysis and the completion of enrollment in the trial earlier than expected. This accelerated accrual reflects the significant interest expressed by the oncology community in mirvetuximab and the need for new treatments in platinum-resistant ovarian cancer."
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.
Revenue by category: license and milestone $11.5 million; non-cash royalty revenue $7.2 million; R&D reimbursement $0.4 million; clinical materials $0.7 million.
Mirvetuximab soravtansine for FRα-positive platinum-resistant ovarian cancer Phase 3 trial FORWARD I completed enrollment and should report top line results in the first half of 2019. 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. "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 data to be updated as ASCO.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. An expansion cohort is being enrolled. There are also academic studies underway.
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 was presented at ASH. Also looking to possible combination studies. The Phase 2 dose should be identified by end-of-year.
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. It is intended to treat "a range of hematological malignancies, including AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN)." Initial data in Q4 2018.
Partner Takeda filed an IND for TAK-164, for GCC-positive tumors. It is an ADC using the IGN platform. Phase 1 should start in Q2 2018.
Cash and equivalents ended at $218.4 million, down sequentially from $267 million. No debt, but lists Other long-term liabilities at $153.5 million.
ImmunoGen believe cash should last until Q4 2019, long enough to get the critical results.
Operating expenses were $56.6 million consisting of: $44.8 million R&D; $9.9 million general and administrative; restructuring $1.7 million. Loss from operations $36.7 million. Non-cash interest expense of on future royalty $3.0 million. Other income $1.2 million. No tax.
Q&A:
Collaboration with Clovis, timeline? We are a cosponsor of a trial at Ohio State. We don't have a timeline, but will update you when they update us.
Mirv partnership in Europe timeline? The highest value would come after the Forward I data is released, though we have already seen interest. It would need to enhance shareholder value by enabling further expansion.
Mirv plus Avastin prior lines of therapy? Earlier data was on 14 patients with 6 prior. Expansion maximum is 5, so a less pretreated cohort.
Norwood shutdown severance? $1.7 million in Q1, smaller amounts will show up in remaining quarters.
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