ImmunoGen, Inc. Reports Third Quarter Fiscal Year 2013 Financial Results and
Provides Quarterly Update
*First product with ImmunoGen’s ADC technology, Kadcyla™, launched in the
US. Multiple additional markets, indications expected.
*Three novel wholly owned ImmunoGen compounds advancing in clinical
testing, with the first clinical data for IMGN853 to be reported at ASCO.
Preclinical data for fourth compound, IMGN289, were reported at AACR, with
clinical testing expected to begin later this year.
*First clinical findings reported at AACR for mesothelin-targeting partner
compound, with clinical findings for additional compounds expected to be
reported in 2013.
WALTHAM, Mass. -- April 26, 2013
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops
anticancer therapeutics using its Targeted Antibody Payload (TAP)
antibody-drug conjugate (ADC) technology, today reported financial results for
the three-month period ended March 31, 2013 – the third quarter of the
Company’s 2013 fiscal year – and provided an update on the Company.
“Based on published clinical findings and patient anecdotes, we believe
Kadcyla will make a notable difference for many patients and become a highly
successful product,” commented Daniel Junius, President and CEO. “The first
Kadcyla sales information reported by Roche in its quarterly update support
that the product launch is off to a good start. As noted previously, we will
be reporting our royalty revenue from Kadcyla one quarter in arrears and thus
it will begin to be reported in our next quarter.”
Mr. Junius continued, “While we are highly excited about Kadcyla, we believe
even greater value for our shareholders will come from our wholly owned
compounds. Patient enrollment is going well in our IMGN901, IMGN853, and
IMGN529 clinical trials, and we are on track to advance our next compound,
IMGN289, into the clinic later this year. Each of these compounds is highly
differentiated and has the potential to become an important therapy for
cancers that need better treatment options.”
Product Pipeline Update
*Kadcyla (ado-trastuzumab emtansine, previously T-DM1) is a HER2-targeting
product with ImmunoGen’s TAP technology that is being developed and
commercialized by Roche under an agreement with ImmunoGen.
On February 22, 2013, Kadcyla gained US FDA marketing approval for the
treatment of people with HER2-positive metastatic breast cancer (BC) who
had received prior treatment with Herceptin® (trastuzumab) and a taxane
chemotherapy. The product was launched shortly thereafter, and Roche
reported Kadcyla sales of 18 million CHF (approximately $19.5 million) in
its quarter ending March 31, 2013. Marketing applications are also under
review in Europe and Japan, and Roche expects Kadcyla approval in Europe
by late 2013.
Roche is developing Kadcyla for a number of additional indications. It
expects data from its MARIANNE Phase III trial evaluating the product for
first-line treatment of HER2-positive metastatic BC in early 2014 and to
apply for marketing approval in the US and Europe for this use in 2014.
Roche is evaluating Kadcyla for the treatment of advanced HER2-positive
gastric cancer in its GATSBY trial and expects to submit for approval for
this use in 2015. Roche plans to also evaluate Kadcyla for the treatment
of early stage HER2-positive BC in three different settings, with the
first of these trials, KATHERINE, now underway.
*IMGN901 is a CD56-targeting TAP compound wholly owned by ImmunoGen.
Patient enrollment is progressing well in the Company’s NORTH Phase II
trial assessing IMGN901 for the first-line treatment of small-cell lung
cancer, used in combination with etoposide/carboplatin (E/C). The study
design provides for an evaluation of the findings in the first 59 patients
enrolled (39 randomized to IMGN901 plus E/C; 20 to E/C alone) that
ImmunoGen had hoped would enable the Company to make certain
development-related decisions in the later part of 2013. As reported
earlier this month, ImmunoGen now anticipates making these decisions based
on the findings in the full patient population of the trial due to a
change in the starting dose during the trial, and expects to have data
from this population in mid-2014.
*IMGN853 is a folate receptor α (FOL)-targeting TAP compound wholly owned
Patient enrollment also is progressing well in the Company’s
first-in-human IMGN853 PhaseI trial, and data from its dose-finding
portion will be reported at the American Society of Clinical Oncology
(ASCO) annual meeting in June 2013. The expansion phase of this trial will
evaluate IMGN853 specifically in patients with FOL-overexpressing ovarian
cancer (OC), particularly platinum-resistant OC, and in patients with
FOL-overexpressing adenocarcinoma non-small cell lung cancer (NSCLC).
*IMGN529 is a potential treatment for CD37-positive hematological
malignancies including non-Hodgkin lymphoma (NHL); it is wholly owned by
The Company expects to report clinical data from the IMGN529
first-in-human PhaseI trial in NHL at a medical conference in late 2013.
This trial is currently in the dose-finding phase. Like Kadcyla, IMGN529
employs ImmunoGen’s TAP technology with an antibody with anticancer
properties of its own.
*IMGN289 is a potential treatment for EGFR-overexpressing cancers,
including squamous cell carcinoma of the head and neck and NSCLC, and is
wholly owned by ImmunoGen.
The first preclinical data with IMGN289 were reported at the annual
meeting of the American Association for Cancer Research (AACR) and showed
that IMGN289 can kill EGFR-overexpressing cancer via direct cell-killing
as well as via EGFR-inhibition. Consequently, it was highly active against
EGFR-overexpressing cancers, including those resistant to tyrosine kinase
inhibitors and those not dependent on EGFR signaling. It also demonstrated
potential for a favorable tolerability profile.
The Company expects to submit the IMGN289 Investigational New Drug (IND)
application in mid-2013 and to begin its clinical testing in 2H 2013.
*In addition to Kadcyla, seven other compounds are in clinical testing
through ImmunoGen’s partnerships, with additional compounds in earlier
stages of development.
The first clinical data were reported at AACR for the mesothelin-targeting
TAP compound, BAY 94-9343, in development by Bayer HealthCare. These data
were from the dose-escalation part of the first-in-human Phase I trial and
showed the compound was generally well tolerated and demonstrated evidence
of activity among patients treated at higher dose levels. The compound is
now being evaluated specifically in patients with either mesothelioma or
OC in the expansion phase of this trial.
ImmunoGen expects clinical data to be reported for most, if not all, of
the remaining six clinical-stage partner compounds in 2013.
Financial Results and Guidance
ImmunoGen reported a net loss of $1.4 million, or $0.02 per basic and diluted
share, for the quarter ending March 31, 2013 (3Q FY2013), as compared to a net
loss of $18.7 million, or $0.24 per basic and diluted share, for the same
quarter of the last year (3Q FY2012).
Revenues for 3Q FY2013 were $25.0 million, compared to $3.3million for 3Q
FY2012. Current quarter revenues include the $10.5 million milestone payment
from Roche earned with the approval of Kadcyla in the US, and $11.1 million of
amortization of upfront license fees received from Novartis. Revenues in 3Q
FY2013 also comprise $2.3million of research and development support fees and
$0.7 million of clinical material reimbursement, compared to $1.3million and
$0.9 million, respectively, for the same quarter last year.
Operating expenses for 3Q FY2013 were $26.3 million, compared to $22.0 million
in the same quarter last year. Operating expenses in 3Q FY2013 include
research and development expenses of $21.3 million, compared to $16.9 million
in 3Q FY2012. This change is primarily due to increased spending 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 and also increased personnel expenses. Additionally,
operating expenses include general and administrative expenses of $5.0million
in both 3Q FY2013 and 3Q FY2012.
ImmunoGen had approximately $206.1 million in cash and cash equivalents as of
March 31, 2013 and no debt. Cash used in operations was $48.7 million in the
first nine months of FY2013, compared with $18.1million in the same period in
FY2012. Capital expenditures were $2.4million and $1.8 million for the first
nine months of FY2013 and FY2012, respectively.
ImmunoGen now expects its net loss for its fiscal year ending June 30, 2013 to
be between $76million to $80 million, its net cash used in operations to be
between $65 million to $69million, 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 $186 million to $190 million.
This compares with previous guidance, issued in January 2013, of a projected
net loss between $70million to $74 million, net cash used in operations of
between $78 million to $82 million, comparable capital expenditures, and
ending the fiscal year on June 30, 2013 with cash and cash equivalents between
$172 million to $176 million.
“We expect our net cash used in operations to be lower than previously
projected – driving our ending cash balance higher – primarily because of
lower than expected operating expenses and working capital needs,” commented
Gregory Perry, Executive Vice President and CFO. “Also, we now anticipate that
some licenses that we had expected to be taken in this fiscal year may be
taken in our 2014 fiscal year, shifting the recognition of the associated
deferred revenue into our next fiscal year. As a result, we have increased our
projected net loss in our revised guidance.”
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 913-312-0843.
Passcode is 4566767. 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 May 10, 2013.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company's TAP
technology uses a tumor-targeting monoclonal antibody to deliver one of
ImmunoGen's highly potent cancer-cell killing agents specifically to tumor
cells. Ten TAP compounds are now in the clinic, of which three are wholly
owned by the Company. The most advanced compound using ImmunoGen's TAP
technology, Kadcyla, has been approved for marketing in the US and is
undergoing regulatory review in Europe and Japan; it is being commercialized
in the US by Genentech, a member of the Roche Group. More information about
ImmunoGen can be found at www.immunogen.com.
Herceptin® is a registered trademark of Genentech. Kadcyla™ is a trademark of
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 cash
equivalents 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
March 31, June 30,
Cash and cash equivalents $ 206,103 $ 160,938
Other assets 22,579 19,370
Total assets $ 228,682 $ 180,308
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $ 16,814 $ 16,254
Long-term portion of deferred revenue and other 72,866 80,164
Shareholders' equity 139,002 83,890
Total liabilities and shareholders' equity $ 228,682 $ 180,308
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended Nine Months Ended
March 31, March 31,
2013 2012 2013 2012
License and $ 22,010 $ 999 $ 23,372 $ 8,211
development 2,257 1,320 5,670 $ 3,333
materials 734 933 2,662 1,861
Total revenues 25,001 3,252 31,704 13,405
Research and 21,318 16,933 66,674 49,653
General and 4,995 5,021 16,098 14,696
Total operating 26,313 21,954 82,772 64,349
Loss from (1,312 ) (18,702 ) (51,068 ) (50,944 )
Other (expense) (39 ) 33 132 39
Net loss $ (1,351 ) $ (18,669 ) $ (50,936 ) $ (50,905 )
Net loss per
common share, $ (0.02 ) $ (0.24 ) $ (0.61 ) $ (0.66 )
shares 84,279 76,961 83,923 76,615
Carol Hausner, 781-895-0600
Executive Director, Investor Relations and Corporate Communications
The Yates Network
Barbara Yates, 781-258-6153
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