ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, today reported financial results for the three-month period and fiscal year ended June 30, 2011.
"Our product pipeline is both advancing and broadening, increasingly through our own progress as well as through that of our partners," commented Daniel Junius, President and CEO. "Trastuzumab emtansine, or T-DM1, continues to be the most advanced compound, with Roche expecting to report data from the EMILIA Phase III trial by mid-2012 and to apply for marketing approval in the US and Europe soon after. We expect as many as three other TAP compounds to have started Phase II testing by mid-2012, including our wholly owned IMGN901 compound. We also expect five additional TAP compounds to enter the clinic during this time period, including our wholly owned IMGN529 and IMGN853 product candidates."
Clinical-Stage Product Candidates
Trastuzumab emtansine (T-DM1) - In global development by Roche for the treatment of HER2+ breast cancer (BC) under a licensing agreement with ImmunoGen.
- 2nd-line metastatic BC - Roche expects to report data from the Phase III EMILIA trial by mid-2012 and to apply in 2012 for marketing approval in the US and Europe.
- 1st-line metastatic BC - Mature data from the completed Phase II trial have been submitted for presentation at the ESMO annual meeting in September 2011. Roche expects to apply for marketing approval for this use in 2014 with data from the MARIANNE Phase III trial.
- Other - Roche initiated a Phase II safety trial in the adjuvant/neoadjuvant BC setting in 4Q2010. Separately, the compound was found to be active against gastric cancer in several recently published preclinical studies.
Lorvotuzumab mertansine (IMGN901) - wholly owned ImmunoGen product candidate for small-cell lung cancer (SCLC) and other CD56+ cancers.
- SCLC - Continued progress is being made in the Phase I trial designed to establish the dose of IMGN901 plus etoposide/carboplatin (E/C) to be used in later-stage clinical testing. The Company expects to begin assessment of this combination to treat newly diagnosed metastatic SCLC in a randomized Phase II trial in late 2011/early 2012 and to report initial data from that trial in 2H2012.
- Merkel cell carcinoma (MCC) - The Company anticipates the IMGN901 plus E/C dose being established could be used in an MCC pivotal trial should the Company determine there is a benefit in aggressively developing IMGN901 for MCC as well as for SCLC.
- Multiple myeloma - Positive data from a Phase I trial evaluating the compound in combination with lenalidomide (Revlimid®)/dexamethasone were presented at ASCO in June 2011, and patient enrollment is underway in the expansion phase of this study. The trial evaluating IMGN901 used alone to treat this cancer has been completed.
SAR3419 - ImmunoGen-created CD19-targeting TAP compound in development by Sanofi for non-Hodgkin's lymphoma (NHL).
- Phase I clinical data were presented at ASCO and in an oral presentation at the 11th International Conference on Malignant Lymphoma in June 2011 that showed the compound achieved a 33% objective response rate when given at its maximum tolerated dose to patients with relapsed/refractory NHL. SAR3419 demonstrated activity against rituximab (Rituxan®)-resistant and -responsive disease and across histological tumor types.
- Sanofi expects to begin Phase II testing of SAR3419 in 2H2011. Its clinical program is designed to support the rapid progression of the compound into pivotal testing.
IMGN388, SAR650984, SAR566658 and BT-062 are progressing in early-stage clinical testing through programs being implemented by ImmunoGen, Sanofi, and Biotest, respectively. The IND for an additional TAP compound, BAY 94-9343, has been submitted by Bayer HealthCare Pharmaceuticals.
Lead Preclinical Product Candidates
The Company expects five additional TAP compounds to advance into clinical testing in the coming months for a total of 13 compounds in clinical development by mid-2012.
IMGN529 - Wholly owned ImmunoGen product candidate for B-cell malignancies such as NHL and chronic lymphocytic leukemia. IMGN529 uses the Company's TAP technology with an antibody that has potent anticancer activity of its own. The Company expects to submit the IMGN529 IND in late 3Q2011.
IMGN853 - Wholly owned ImmunoGen product candidate for cancers that over-express folate receptor 1, which include ovarian cancer. IMGN853 uses an antibody selected by ImmunoGen scientists based on its payload delivery proficiency and a new linker developed by the Company to combat multi-drug resistance. The Company expects to submit the IMGN853 IND in early 2012.
Three additional TAP compounds are expected to enter the clinic by mid-2012 through ImmunoGen partners.
Fiscal Year 2011 Financial Results
For the Company's fiscal year ended June 30, 2011 (FY2011), ImmunoGen reported a net loss of $58.3 million, or $0.85 per basic and diluted share, compared to a net loss of $50.9 million, or $0.87 per basic and diluted share, for its fiscal year ended June 30, 2010 (FY2010). For the quarter ending June 30, 2011 (4QFY2011), ImmunoGen reported a net loss of $16.2 million, or $0.23 per basic and diluted share, compared to a net loss of $13.4 million, or $0.21 per basic and diluted share, for the same quarter in FY2010.
Revenues in FY2011 were $19.3 million, compared to $13.9 million in FY2010. Revenues in FY2011 include $7.3 million of research and development support fees, compared to $5.4 million in FY2010. This increase is driven by agreements with partners entered into in FY2011 and FY2010. Revenues in FY2011 also include $6.4 million of license and milestone fees compared to $5.7 million in FY2010. The FY2011 fees include $3.0 million in milestone payments earned with the advancement of two TAP compounds into clinical testing by collaborative partners. The FY2010 fees include $2.5 million in milestone payments earned with preclinical and early-stage clinical product achievements by two collaborative partners. Revenues in FY2011 also include $5.7 million of clinical material reimbursement, compared to $2.9 million in FY2010. The increase is primarily due to an increase in the number of clinical material batches released in FY2011 compared with FY2010.
Operating expenses in FY2011 were $79.5 million, compared to $65.2 million in FY2010. Operating expenses in FY2011 include research and development expenses of $63.5 million, compared to $50.3 million in FY2010. This increase is primarily due to greater Company investment behind aggressively developing its own product candidates, including costs associated with expanded patient enrollment in clinical trials and the advancement of IMGN529 and IMGN853 toward IND filing. It also includes increased salary and related expenses driven by additional personnel and greater stock compensation expense and by increased cost of clinical materials reimbursed related to increased manufacturing on behalf of our partners. General and administrative expenses increased modestly between FY2010 and FY2011 - from $14.9 million to $16.0 million, respectively - with the difference primarily due to increased patent and personnel costs.
Other income (expense), net, was $1.9 million in FY2011, compared to $58,000 in FY2010. Other income in FY2011 includes $1.2 million of federal grant funding that the Company was awarded in 2QFY2011. The Company had received $1.1 million of this funding as of June 30, 2011.
ImmunoGen had approximately $191.2 million in cash, cash equivalents and marketable securities as of June 30, 2011 - inclusive of net proceeds of $88.0 million from a public offering of common equity in 4QFY2011 - compared with $110.3 million as of June 30, 2010; the Company had no debt outstanding in either period. Cash used in operations was $8.0 million in FY2011, compared with $40.6 million in FY2010. Cash used in operations in FY2011 benefited from the $45 million upfront payment received from Novartis in 2QFY2011. Capital expenditures were $2.0 million for FY2011, compared to $1.5 million for FY2010.
Financial Guidance
ImmunoGen expects its net loss for its fiscal year ending June 30, 2012 to be between $65-70 million, its cash used in operations to be between $60-65 million, and its capital expenditures to be between $4-5 million. Cash and marketable securities at June 30, 2012 are anticipated to be between $125-130 million.
"Our strong balance sheet enables us to aggressively advance our own product candidates to value inflection points," commented Gregory Perry, Executive Vice President and CFO. "At the same time, our partnerships are providing us with cash that partially funds our investment in our product programs. We believe we have ample liquidity to last us well past the commercialization of the first TAP compound by our partners."
Neoantigen DNA vaccines improve survival and immunity in triple-negative breast cancer patients