conference date: August 4, 2016 @ 5:00 AM PT
for quarter ending: June 30, 2016 ( fourth fiscal quarter 2016)
Overview: Received FDA permission to start a Phase 3 trial with the lead candidate.
Basic data (GAAP):
Revenue was $7.4 million, down sequentially from $19.7 million, and down from $12.6 million year-earlier.
Net income was negative $44.8 million, sequentially from negative $31.9 million, down from negative $30.5 million year-earlier.
Diluted EPS was negative $0.51, sequentially from negative $0.37, and down from negative $0.35 year-earlier.
"ImmunoGen is transitioning to a fiscal year ending December 31, effective January 1, 2017. For the six months ending December 31, 2016, ImmunoGen expects: revenues to be between $40 million and $45 million; operating expenses to be between $95 million and $100 million; net loss to be between $55 million and $60 million; cash used in operations to be between $65 million and $70 million; and capital expenditures to be between $2 million and $5 million. Cash and marketable securities at December 31, 2016 are anticipated to be between $170 million and $175 million."
"We will build upon ImmunoGen's leadership position in ADCs by focusing on four strategic priorities: complete development and commercialize mirvetuximab soravtansine, accelerate our earlier-stage portfolio, continue to drive innovation in ADCs for the treatment of cancer, and support new and existing partnerships. As we execute on these priorities, we will look to improve the efficiency of our operations and more effectively manage our cash position," said Mark Enyedy, CEO. [ADC = antibody drug conjugate]
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 $5.9 million; R&D reimbursement $1.3 million; clinical materials $53 thousand.
Mirvetuximab soravtansine Phase 1 expansion cohort for FRα-positive platinum-resistant ovarian cancer presented at ASCO data was positive. The Phase 2 trial has been modified to be a Phase 3 trial following a meeting with the FDA. 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 also began a Phase 2 trial, FORWARD II. Will also have cohorts in combination with PLD, carboplatin, and Keytruda.
IMGN779 started 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.
IMGN529 started a Phase 2 trial soon for DLBCL (diffuse large B-cell lymphoma). It has orphan drug designation.
IMGN632 has advanced to pre-IND testing.
Sanofi's SAR566658 presented Phase 1 results at ASCO.
Bayer's anetumab revtansine Phase 1 results presented at ASCO.
Believes that new payloads, linkers, and antibodies will allow more types of cancer to be treated.
Cash and equivalents ended at $245 million. Long-term liabilities were $307 million, mostly long-term deferred revenue from Kadcyla future royalty deal.
Operating expenses were $46.8 million consisting of: $37.5 million R&D and $9.3 million general and administrative. Loss from operations $39.4 million. Non-cash interest expense of on future royalty $5.0 million. Other expense $0.4 million. No tax.
Daniel Junius retired as President and CEO on May 16.
Is undertaking a cash management review in order to extend runway to two years. That should get programs through several significant value inflection points.
See also March 30, 2015 press release ImmunoGen Announced $200 Million Royalty Transaction.
6.7 months of PFS with subpopulation for ovarian cancer, similarity to low FRα? The number of patients with low expression was relatively small. We designed the Phase 3 trial to give us the best shot at a positive outcome. We could do a trial with low FRα later.
Meeting with FDA color? The main points were PFS as the primary endpoint. The size of the safety database. Statistical plan, the population we chose.
FORWARD I study response based endpoints? We did not lay out alternative endpoints to PFS to the FDA. We believe data could be available in 2019.
FORWARD I physicians choice? Just a guess there will be a small amount of topotecan, the rest about evenly split between PLD (pegylated doxorubicin) and paclitaxel.
FORWARD I control group variability? We don't know. We believe we will be competitive with all three alternative single agent choices.
Endometrial study not in presentation? We've been completing the initial cohort and will present data next year. Our priority is FORWARD I.
Despite the Phase 3 trial and investing in the early pipeline, we expect to have cash to get to at least mid 2018. That includes expected milestone revenue.
FRα population overlap with BRACA mutations? BRACA mutations tend to get 2 or 3 rounds of population before they become platinum resistant, so they are not likely to be in our target population.
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