ImmunoGen, Inc. Reports Second Quarter Fiscal Year 2013 Financial Results
and Provides Quarterly Update
*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 findings also are expected to be reported for multiple partner
compounds, with next compound on track to advance into pivotal testing in
WALTHAM, Mass. -- January 25, 2013
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
*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
*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
*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
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 $5.5million 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 $24.0million 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 $70million to $74 million, its net cash used in operations to
be between $78 million to $82million, 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 results. To access the live call by phone, dial 913-312-0721.
Passcode is 8098402. The call also may be accessed through the Investor
Information section of the Company's website, www.immunogen.com. Following the
live webcast, a replay of the call will be available at the same location
through February 8, 2013.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using its TAP
technology together with the Company’s expertise in monoclonal antibodies and
tumor biology. A TAP compound uses a tumor-targeting monoclonal antibody to
deliver one of ImmunoGen's purpose-developed cancer-killing agents
specifically to tumor cells. Ten TAP compounds are now in clinical testing, of
which three are wholly owned by the Company. Marketing applications for
trastuzumab emtansine (T-DM1), the most advanced compound using ImmunoGen's
TAP technology, are under review in the US and Europe. Roche is developing
this compound globally under an agreement between ImmunoGen and Genentech, a
member of the Roche Group. More information about ImmunoGen can be found at
Herceptin® is a registered trademark of Genentech. Revlimid® is a registered
trademark of Celegene Corporation.
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 2013 fiscal year; its cash and
marketable securities as of June 30, 2013; 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, 2012 and other reports filed with the Securities and Exchange
SELECTED FINANCIAL INFORMATION
(in thousands, except per share amounts)
CONDENSED CONSOLIDATED BALANCE SHEETS
December 31, June 30,
Cash and cash equivalents $ 211,021 $ 160,938
Other assets 19,816 19,370
Total assets $ 230,837 $ 180,308
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $ 14,628 $ 16,254
Long-term portion of deferred revenue and 80,214 80,164
other long-term liabilities
Shareholders' equity 135,995 83,890
Total liabilities and shareholders' equity $ 230,837 $ 180,308
Three Months Ended Six Months Ended
December 31, December 31,
2012 2011 2012 2011
development $ 2,036 $ 945 $ 3,413 $ 2,013
License and 429 6,025 1,362 7,212
materials 147 647 1,928 928
Total revenues 2,612 7,617 6,703 10,153
Research and 21,656 15,559 45,356 32,720
General and 5,464 4,834 11,103 9,675
operating 27,120 20,393 56,459 42,395
Loss from (24,508 ) (12,776 ) (49,756 ) (32,242 )
Other income, 115 23 171 6
Net loss $ (24,393 ) $ (12,753 ) $ (49,585 ) $ (32,236 )
Net loss per
common share, $ (0.29 ) $ (0.17 ) $ (0.59 ) $ (0.42 )
shares 84,147 76,523 83,748 76,443
Carol Hausner, 781-895-0600
Executive Director, Investor Relations
and Corporate Communications
The Yates Network
Barbara Yates, 781-258-6153
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