Fri, Jul 25, 2014, 12:31 AM EDT - U.S. Markets open in 8 hrs 59 mins

Recent

% | $
Click the to save as a favorite.

ImmunoGen, Inc. Message Board

  • bluecheese4u bluecheese4u Jan 25, 2013 9:10 AM Flag

    ImmunoGen, Inc. Reports Second Quarter Fiscal Year 2013 Financial Results and Provides Quarterly Update

    ImmunoGen, Inc. Reports Second Quarter Fiscal Year 2013 Financial Results and Provides Quarterly Update

    January 25, 2013

    Trastuzumab emtansine (T-DM1) marketing applications are under review in the US and Europe; US application has priority review status with a PDUFA date of February 26, 2013.
    In 2013, ImmunoGen expects to report clinical findings with its three lead wholly owned compounds and to advance its fourth compound, IMGN289, into clinical testing.
    Clinical findings also are expected to be reported for multiple partner compounds, with next compound on track to advance into pivotal testing in 2013.
    WALTHAM, Mass.--(BUSINESS WIRE)-- ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops anticancer products using its Targeted Antibody Payload (TAP) technology and antibody expertise, today reported financial results for the three-month period ended December 31, 2012 — the second quarter of the Company's 2013 fiscal year — and provided an update on the Company.

    "We expect 2013 to be a very important year for ImmunoGen," commented Daniel Junius, President and CEO. "Roche is anticipating the approval of T-DM1 in the US early this year followed by approval in Europe later in 2013. We believe the launch of T-DM1 will be momentous for appropriate patients, their families, and their physicians. It will also mark the start of ImmunoGen earning what we believe will be a significant royalty stream."

    Mr. Junius continued, "We also believe that, in 2013, ImmunoGen's progress on our proprietary pipeline will become more apparent. Over the course of the year, we expect to report clinical findings for our three lead TAP compounds and to advance our fourth, IMGN289, into clinical testing. We believe each of these compounds has the potential to be transformative to the treatment of its targeted cancer and we've designed development programs to advance each compound through proof of concept as promptly as possible."

    Product Pipeline Update

    Lead compound with ImmunoGen's TAP technology, T-DM1, is in global development by Roche:
    The T-DM1 marketing applications for treatment of people with HER2+, unresectable locally advanced or metastatic breast cancer who have received prior treatment with Herceptin® (trastuzumab) and a taxane are under review in the US and Europe. Roche has noted that the US submission has been granted priority review status by the FDA with a PDUFA goal date of February 26, 2013. Roche also expects European approval of T-DM1 in 2013.
    Roche expects to report data from its Ph III trial, MARIANNE, evaluating T-DM1 for first-line treatment of HER+ metastatic breast cancer in early 2014 and to apply for marketing approval for this use in 2014.
    Roche intends to initiate registration trials in 2013 evaluating T-DM1 in three early stage HER2+ breast cancer settings — adjuvant, neoadjuvant, and residual invasive disease.
    Roche is currently evaluating T-DM1 for the treatment of advanced HER2+ gastric cancer and expects to submit for approval for this use in 2015.
    IMGN901, wholly owned ImmunoGen TAP compound for CD56+ cancers:
    Small-cell lung cancer (SCLC) — The Company remains on track to have the data readout from the first stage of its Simon two-stage NORTH Phase II trial in the second half of 2013 — a readout designed to inform certain development decisions to be made by the Company. ImmunoGen expects to complete patient enrollment for the full trial in 2013, which would enable these findings to be reported in 2014. NORTH evaluates IMGN901 for the first-line treatment of SCLC used in combination with etoposide/carboplatin.
    Multiple myeloma — IMGN901 showed activity in both Revlimid® (lenalidomide)-naïve and -refractory disease in a Phase I trial assessing it used in combination with Revlimid and dexamethasone presented at the ASH annual meeting in December.
    IMGN853, ImmunoGen TAP compound for folate receptor α (FOL)-overexpressing tumors:
    The Company expects the first clinical data with this TAP compound to be reported at a medical conference in mid-2013.
    IMGN853 is a potential treatment for prevalent types of ovarian and non-small cell lung cancers, as well as for other FOL+ solid tumors.
    IMGN529, ImmunoGen TAP compound for CD37+ hematological malignancies:
    IMGN529 is in Phase I testing for the treatment of non-Hodgkin's lymphoma, and the Company expects the first clinical data to be reported at a medical conference in late 2013.
    IMGN529 employs ImmunoGen's TAP technology with an antibody that also has anticancer properties.
    IMGN289, ImmunoGen TAP compound for EGFR-overexpressing solid tumors:
    IMGN289 is expected to be the next wholly owned ImmunoGen compound to advance into clinical testing. The Company expects to submit its IND in mid-2013 and to begin clinical testing in 2H 2013.
    ImmunoGen expects to present data on the preclinical efficacy and tolerability of IMGN289 at a scientific meeting in 2Q 2013.
    In addition to T-DM1, seven other compounds are in clinical testing through ImmunoGen's partnerships:
    Clinical data are expected to be reported with a number of these compounds in 2013.
    A partner compound is projected to advance into pivotal testing in 2013.
    Financial Results and Guidance

    ImmunoGen reported a net loss of $24.4 million, or $0.29 per basic and diluted share, for the quarter ending December 31, 2012 (2Q FY2013), as compared to a net loss of $12.8 million, or $0.17 per basic and diluted share, for the same quarter of the last year (2Q FY2012).

    Revenues for 2Q FY2013 were $2.6 million. This compares to $7.6 million for 2Q FY2012, which included $5.0 million in milestone payments not repeated in 2Q FY2013. Revenues in 2Q FY2013 comprise $2.0 million of research and development support fees, $0.4 million of license and milestone fees, and $0.1 million of clinical material reimbursement, compared to $0.9 million, $6.0 million, and $0.6 million, respectively, for the same quarter last year.

    Operating expenses for 2Q FY2013 were $27.1 million, compared to $20.4 million in the same quarter last year. Operating expenses in 2Q FY2013 include research and development expenses of $21.7 million, compared to $15.6 million in 2Q FY2012. This increase is primarily due to greater investment by the Company to aggressively advance its wholly owned product candidates, and includes increased costs for third-party production of antibody for use in clinical materials, increased clinical trial costs, and increased personnel expenses. Operating expenses also include general and administrative expenses of $5.5 million in 2Q FY2013, compared to $4.8 million in 2Q FY2012. This increase is primarily due to increased patent expenses and recruitment costs.

    ImmunoGen had approximately $211.0 million in cash and cash equivalents as of December 31, 2012 and no debt. Cash used in operations was $42.7 million in the first six months of FY2013, compared with $24.0 million in the same period in FY2012. Capital expenditures were $2.0 million and $0.8 million for the first six months of FY2013 and FY2012, respectively.

    ImmunoGen's financial guidance remains unchanged from that issued in October 2012. ImmunoGen expects its net loss for its fiscal year ending June 30, 2013 to be between $70 million to $74 million, its net cash used in operations to be between $78 million to $82 million, and its capital expenditures to be between $4 million to $5 million. Cash and cash equivalents at June 30, 2013 are anticipated to be between $172 million to $176 million.

    "The expected approval and launch of T-DM1 will be an important milestone in ImmunoGen's history," commented Gregory Perry, Executive Vice President and CFO. "As sales develop, this compound should provide significant royalties that will help fund the advancement of our wholly owned product candidates."

    Conference Call Information

    ImmunoGen is holding a conference call today at 8:00 am ET to discuss the quarterly

    investorDOTimmunogenDOTcom/releasedetailDOTcfm?ReleaseID=735762

 
IMGN
10.89-0.49(-4.31%)Jul 24 3:59 PMEDT

Trending Tickers

i
Trending Tickers features significant U.S. stocks showing the most dramatic increase in user interest in Yahoo Finance in the previous hour over historic norms. The list is limited to those equities which trade at least 100,000 shares on an average day and have a market cap of more than $300 million.