News

  WALTHAM, Mass., Oct 27, 2008 (BUSINESS WIRE) -- ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics using its Tumor-Activated Prodrug (TAP) technology, today announced financial results for the three-month period ended September 30, 2008 -- the first quarter of the Company's 2009 fiscal year.

"Our recent accomplishments underscore that ImmunoGen has entered a new and highly exciting era," commented Mitchel Sayare, Chairman and CEO. "Genentech intends to initiate Phase III testing with its trastuzumab-DM1 TAP compound in the first half of 2009, our collaborator sanofi-aventis has advanced AVE1642 into Phase II testing, and another major pharmaceutical company -- Bayer HealthCare -- recently licensed use of our TAP technology on significantly improved terms consistent with its increased validation. We have three of our own compounds in clinical testing, and another five compounds are in the clinic through our collaborations. This is a great time for us to transition to a new CEO, and I look forward to turning the position over to Dan Junius on January 1, 2009."

Recent Highlights

Financial Results

For the three-month period ended September 30, 2008, ImmunoGen reported a net loss of $9.4million, or $0.19 per basic and diluted share, compared to a net loss of $1.0million, or $0.02 per basic and diluted share, for the same period last year.

Revenues for the three-month period ended September 30, 2008 were $6.1 million, compared to $11.4million for the same quarter last year. First quarter fiscal 2009 revenues include $3.2million of research and development support fees, compared to $4.5million for the same period last year. Research and development support fees primarily represent funding earned pursuant to ImmunoGen's discovery, development, and commercialization collaboration with sanofi-aventis and, to a lesser extent, funding earned under development and license agreements with other collaborative partners. The level of research and development support fees from sanofi-aventis was reduced in the final contract year compared with the previous contract year as more development activity was assumed by sanofi-aventis. The funding under this research contract will complete on October 31, 2008. The Company expects to subsequently conduct research supported by sanofi-aventis on a limited basis.

First quarter fiscal 2009 revenues also include $2.2 million of license and milestone fees, compared to $4.2million for the same quarter last year. Included in license and milestone fees for the first quarter of fiscal 2009 is a $0.5million milestone related to the initiation of Phase I clinical testing of BT-062 by Biotest; ImmunoGen has opt-in rights on this compound. Also during the first quarter of fiscal 2009, Millennium Pharmaceuticals, Inc. and Boehringer Ingelheim agreed to terminate their licenses with ImmunoGen that were no longer being used to develop products. As a result, ImmunoGen recognized as license and milestone fees $0.4 million and $0.5 million, respectively, of upfront fees previously deferred. License and milestone fees for the first quarter of fiscal 2008 included a $3.0million milestone payment related to Genentech's initiation of PhaseII clinical testing with T-DM1.

First quarter fiscal 2009 revenues also include $0.7 million of clinical material reimbursement, compared to $2.8million for the same quarter last year. ImmunoGen manufactures clinical materials on behalf of its collaborators and, as needed, also supplies its collaborators with the Company's DM1/DM4 cytotoxic agents in support of their manufacturing and development efforts, and ImmunoGen earns clinical material reimbursement revenue with the supply of these materials to those collaborators. The lower clinical material reimbursement revenue for the first quarter of fiscal 2009 compared with the same period in the prior year is due to timing of batch acceptance by our collaborators. Additionally, the prior year period included $0.8million in revenue from ImmunoGen supplying a collaborator with one of its cytotoxic agents.

Operating expenses for the three-month period ended September 30, 2008 were $15.5million, compared to $13.3 million in the same period last year. The operating expenses in the first quarter of fiscal 2009 include research and development expenses of $11.9million, compared to $10.8 million for the same quarter last year. The increase in research and development expenses for the quarter ended September 30, 2008 versus the prior-year period is primarily due to increased employee compensation levels and greater clinical trial costs, facility expenses and research supplies. First quarter fiscal 2009 operating expenses also include general and administrative expenses of $3.7million, compared to $2.4 million for the same quarter last year. During the first quarter of fiscal 2009, ImmunoGen recognized $0.7 million of expense related to the modification of the terms on the exercise of options previously granted to Mitchel Sayare in accordance with the CEO succession plan approved by ImmunoGen's Board of Directors in September 2008. Additionally, the current period expenses include $0.3 million in other increases in salary and related expenses compared to the prior-year period primarily due to an increase in personnel.

Other income, net, consisting primarily of interest income, losses realized on investments due to impairment and losses/gains recognized on forward contracts, was $16,000 in the first quarter of fiscal 2009, compared to $0.8 million for the same period last year. Included in other income, net, for the first quarter of fiscal 2009 is $0.3 million of interest income, $0.1 million of impairment charges on investments and $0.1 million of losses recognized on forward contracts. Other income, net, for the first quarter of fiscal 2008 included $0.7 million of interest income and $0.2 million of gains recognized on forward contracts.

ImmunoGen had approximately $44.6 million in cash and marketable securities as of September 30, 2008, compared with $47.9 million as of June 30, 2008, and had no debt outstanding in either period. During the first three months of fiscal 2009, cash used in operations was $2.6 million, compared to $5.8million during the same period last year. Capital expenditures were $0.6 million for the first three months of fiscal 2009, compared to $0.5million for the same period last year.

ImmunoGen expects its net loss for its 2009 fiscal year ending June 30, 2009 to be between $37-40 million, unchanged from previous guidance. The Company further expects its cash used in operations to be between $20-23 million and its capital expenditures to be between $1-3million, also unchanged from previous guidance.

"The advancement of a TAP compound into registration trials is a major milestone for ImmunoGen," commented Daniel Junius, President and COO and Acting CFO. "We're delighted that Genentech intends to initiate Phase III testing of T-DM1 during the first half of 2009 and with the other T-DM1 studies now underway or planned. We're also pleased with the progress sanofi-aventis is making with AVE1642 -- now in Phase II -- as well as with SAR3419. There are now eight compounds in clinical testing through our programs and those of our partners, so our product pipeline is both advancing and expanding while our partnerships help us to reduce the level of our net cash consumption."

Product Pipeline Update

Trastuzumab-DM1 (T-DM1)

T-DM1 comprises ImmunoGen's DM1 cell-killing agent linked to Genentech's anti-HER2 antibody, trastuzumab. Genentech is developing T-DM1 for the treatment of HER2-positive metastatic breast cancer (HER2-positive mbc). In September, encouraging interim findings from the Phase II trial evaluating T-DM1 for "second-line plus" treatment of this cancer were presented at the American Society of Clinical Oncology (ASCO) Breast Cancer Symposium.

• Genentech announced plans to initiate a Phase III trial in the first half of 2009 to evaluate trastuzumab-DM1 (T-DM1) as a second-line treatment for HER2-positive metastatic breast cancer;< >Genentech also reported that patient dosing is underway in its Phase II trial evaluating T-DM1 as a third-line treatment for this cancer, another potential route to market for the compound;Bayer HealthCare licensed exclusive rights to use our TAP technology to develop anticancer compounds to an undisclosed target in October 2008, triggering an upfront payment of $4 million and entitling the Company to milestone payments potentially totaling $170.5 million plus royalties on any commercial sales;ImmunoGen earned a $4 million milestone from sanofi-aventis in October 2008 with their initiation of an AVE1642 Phase II trial;Clinical findings with IMGN901 and IMGN242 were presented at the EORTC-NCI-AACR meeting in October 2008; andIMGN901 clinical findings are expected to be presented at the American Society of Hematology (ASH) annual meeting in December 2008, followed by presentation at the San Antonio Breast Cancer (SABC) Symposium of preliminary findings from the T-DM1 "second-line plus" Phase II trial.Preliminary clinical findings from the "second-line plus" T-DM1 Phase II study have been accepted for oral presentation at the SABC Symposium taking place December 10-14, 2008.< >Genentech announced plans to initiate a Phase III trial in the first half of 2009 to evaluate T-DM1 as a second-line treatment for HER2-positive mbc. ImmunoGen is entitled to receive a milestone payment with the start of patient dosing in a T-DM1 Phase III trial.Genentech also reported that patients are being enrolled in its Phase II trial evaluating T-DM1 as a third-line treatment for HER2-positive mbc, another potential route to market for T-DM1.Additionally, Genentech announced that patient dosing is underway in its Phase II trial comparing T-DM1 to trastuzumab (Herceptin^® plus docetaxel (Taxotere^® as a first-line treatment for HER2-positive mbc. Genentech also reported that it expects to initiate a Phase Ib trial in the first half of 2009 assessing T-DM1 when given in combination with their pertuzumab compound.Sanofi-aventis has a number of clinical trials planned or underway with AVE1642.< >ImmunoGen earned a $4 million milestone payment from sanofi-aventis with their initiation of a Phase II clinical trial with AVE1642 in October 2008.Data were presented last week at the EORTC-NCI-AACR meeting on the rationale for the dose now being used in the Phase II study. The poster also described an impressive response to treatment with IMGN242 that had been seen in one of the first patients enrolled in the study but had not met the criteria for study expansion.Clinical findings for IMGN901, used as a single agent to treat multiple myeloma, have been accepted for presentation at the ASH annual meeting in December 2008.< >The Company expects to initiate a Phase I/II trial assessing IMGN901 in combination with approved therapy for multiple myeloma in the first half of 2009.Clinical data from an IMGN901 PhaseI solid tumor trial (Study 002) were presented at the EORTC-NCI-AACR meeting. IMGN901 was found to be generally well tolerated and evidence of anticancer activity was reported. The maximum tolerated dose of the compound in this study had not yet been established.The first SAR3419 clinical data are expected to be presented in 2009.IMGN388 preclinical data were presented at the EORTC-NCI-AACR meeting last week.< >Patient dosing with IMGN388 began in the summer of 2008.The Company intends to report the first clinical findings with this compound in 2009.Patient dosing with BIIB015 began in the summer of 2008.Patient dosing with BT-062 began in the summer of 2008.