- 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.
- 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.
- Phase I clinical data were presented at ASCO and in an oral presentation at the 11 th 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.
Lead Preclinical Product CandidatesThe 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.”About ImmunoGen, Inc. ImmunoGen, Inc. develops targeted anticancer therapeutics using the Company's expertise in tumor biology, monoclonal antibodies, potent cancer-cell killing agents and engineered linkers. The Company's TAP technology uses monoclonal antibodies to deliver one of ImmunoGen's proprietary cancer-cell killing agents specifically to tumor cells. There are now numerous TAP compounds in clinical development and a wealth of clinical data reported. ImmunoGen’s collaborative partners include Amgen, Bayer HealthCare Pharmaceuticals, Biotest, Novartis, Roche, and Sanofi. The most advanced compound using ImmunoGen's TAP technology, trastuzumab emtansine (T-DM1), is in Phase III testing through the Company's collaboration with Genentech, a member of the Roche Group. More information about ImmunoGen can be found at www.immunogen.com. Revlimid® is a registered trademark of Celgene Corporation. Rituxan® is a registered trademark of Biogen Idec. This press release includes forward-looking statements based on management's current expectations. These statements include, but are not limited to, ImmunoGen's expectations related to: the Company's net loss, cash used in operations and capital expenditures in its 2012 fiscal year; its cash and marketable securities as of June 30, 2012; the occurrence, timing and outcome of potential pre-clinical, clinical and regulatory events related to the Company's and its collaboration partners' product programs; and the presentation of preclinical and clinical data on the Company’s and collaboration partners’ product candidates. For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. Various factors could cause ImmunoGen's actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this release. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the timing and outcome of ImmunoGen's and the Company's collaboration partners' research and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense and results of preclinical studies, clinical trials and regulatory processes; ImmunoGen's ability to financially support its product programs; ImmunoGen's dependence on collaborative partners; industry merger and acquisition activity; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the fiscal year ended June 30, 2010 and other reports filed with the Securities and Exchange Commission.
|SELECTED FINANCIAL INFORMATION|
|(in thousands, except per share amounts)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|June 30,||June 30,|
|Cash, cash equivalents and marketable securities||$||191,206||$||110,298|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Long-term portion of deferred revenue and other long-term liabilities||63,106||21,338|
|Total liabilities and shareholders' equity||$||217,641||$||137,208|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||Year Ended|
|June 30,||June 30,|
|Research and development support||$||1,566||$||1,495||$||7,256||$||5,365|
|License and milestone fees||2,859||1,774||6,393||5,698|
|Clinical materials reimbursement||2,080||1,153||5,656||2,880|
|Research and development||18,261||13,790||63,453||50,280|
|General and administrative||4,438||3,973||16,040||14,898|
|Total operating expenses||22,699||17,763||79,493||65,178|
|Loss from operations||(16,194||)||(13,341||)||(60,188||)||(51,235||)|
|Other income (expense), net||44||(64||)||1,914||58|
|Loss before taxes||(16,150||)||(13,405||)||(58,274||)||(51,177||)|
|Benefit for income taxes||-||-||-||(265||)|
|Net loss per common share, basic and diluted||$||(0.23||)||$||(0.21||)||$||(0.85||)||$||(0.87||)|
|Average common shares outstanding, basic and diluted||71,315||63,851||68,919||58,845|