conference date: October 28 , 2016 @ 5:00 AM Pacific Time
for quarter ending: September 30, 2016 (first fiscal quarter 2017)
Overview: Close to initiating the Phase 3 trial for mirvetuximab soravtansine for ovarian cancer.
Basic data (GAAP):
Revenue was $7.7 million, up sequentially from $7.4 million, but down from $14.9 million year-earlier.
Net income was negative $44.7 million, nearly flat sequentially from negative $44.8 million, down from negative $33.7 million year-earlier.
Diluted EPS was negative $0.51, flat sequentially from negative $0.51, and down from negative $0.39 year-earlier.
For the second half of calendar 2016 revenue is expected between $25 and $30 million, a reduction reflecting timing of partner milestone payments. Operating expense $90 to $95 million. Net loss $70 to $75 million. Cash used in operations same as net loss. Capital expense $2 to $5 million. Expects to have $165 to $170 million in cash remaining at the end of the period.
"We prioritized our portfolio to focus on initiating Phase 3 development of and generating combination data with mirvetuximab soravtansine, as well as accelerating our earlier-stage IGN programs, IMGN779 and IMGN632. We look forward to starting our registration-enabling trial for mirvetuximab soravtansine before the end of the year and to an oral presentation for IMGN632 at ASH. Together with our strong cash position, the steps we have undertaken as part of our strategic review will enable us to fund our operations through the FORWARD I interim analysis and into mid-2018." said Mark Enyedy, CEO.
Immunogen will shift from fiscal year reporting to calendar year reporting on January 1, 2017.
Revenue by category: license and milestone $76 thousand; non-cash royalty revenue $6.2 million; R&D reimbursement $1.4 million; clinical materials $46 thousand.
Mirvetuximab soravtansine for FRα-positive platinum-resistant ovarian cancer Phase 3 trial FORWARD I should begin before the end of 2016. PFS (progression free survival) will be the primary endpoint. There will be 333 patients with high or medium FRα levels randomized 2:1 against physician's choice of single agent chemotherapy.
Mirvetuximab soravtansine plus Avastin is in a Phase 2 trial, FORWARD II. Will also have cohorts in combination with PLD, carboplatin, and Keytruda.
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. Preclinical data will be presented at ASH in December. Phase 1 data should be reported in 2017.
IMGN529 is in a Phase 2 trial soon for DLBCL (diffuse large B-cell lymphoma). It has orphan drug designation.
IMGN632 preclinical data will be presented at ASH in December. Phase 1 for a hematological malignancy should start in 2017.
Believes that new payloads, linkers, and antibodies will allow more types of cancer to be treated.
Cash and equivalents ended at $196 million, down sequentially from $245 million. Long-term liabilities were $100 million in convertible debt and $198 million, mostly long-term deferred revenue from Kadcyla future royalty deal.
Operating expenses were $46.5 million consisting of: $32.9 million R&D and $9.5 million general and administrative. Loss from operations $38.8 million. Non-cash interest expense of on future royalty $5.0 million. Other expense $0.8 million. No tax.
There were a number of charges in the quarter related to restructuring.
ImmunoGen has undertaken a cash management review in order to extend runway to two years. That should get programs through several significant value inflection points.
Potential milestone payments for 2017? They depend on progress made by our partners. It will likely be less than 2016. We will give full guidance at the beginning of 2017.
779 trial, any prophylactic use of steroid or teardrops? We do not expext occular issues, so there is no planned steroid or eyedrop use.
Divestiture of products? We only have preliminary conversations ongoing at this point.
Q4 $25 to $30 million burn? Going forward $30 to $35 million burn per quarter.
Keytruda cohort of FORWARD II? The first patient was dosed last month, we are just getting started, so far so good.
Timing of FORWARD II data presentation? We are confident dose escalation data will be ready in time for ASCO, the expansion cohorts depend on timing.
Any financial covenants that came with convertible debt? No, plain vanilla convertible.
We are gathering data on patient FRα levels in the FORWARD II trial.
FRα cancer and BRCM cancer expression, PARP inhibitors? FRα levels and BRCM and not mutually exclusive, but they are not entirely overlapping either. PARPs are making progress in the ovarian cancer maintenance space, which is not what is being targetted with mirvetuximab soravtansine.
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