ImmunoGen, Inc. Reports Fourth Quarter and Fiscal Year 2012 Financial Results and Provides Corporate Update and Fiscal Year 2013 Guidance
-
Positive Phase III results with trastuzumab emtansine (T-DM1) were
presented in a plenary session at ASCO in June; Roche intends to use
these data to apply in 2012 for marketing approval of the compound for
the use evaluated.
-
ImmunoGen expects up to three additional partner compounds to begin
pivotal testing in late 2013.
-
ImmunoGen advanced its third wholly owned product candidate into
clinical testing in July 2012 and remains on track to submit an IND
for its fourth compound by mid-2013.
-
Recent public stock offering further strengthens ImmunoGen's
balance sheet, enhancing the Company's ability to aggressively fund
advancement of its proprietary product candidates.
WALTHAM, Mass.--(BUSINESS WIRE)--
ImmunoGen,
Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted
anticancer products using its antibody expertise and Targeted Antibody
Payload (TAP) technology, today reported financial results for the
three-month period and fiscal year ended June 30, 2012 and provided an
update on the Company.
"We believe the trastuzumab emtansine clinical data reported at ASCO
convey the transformational potential of our TAP technology," commented
Daniel Junius, President and CEO. "It is impressive to see a new product
candidate demonstrate both greater efficacy and better tolerability than
standard care, and is noteworthy that these benefits were seen for a
cancer in which considerable progress already had been made. It also was
significant that these were found in a solid tumor indication —
approximately ninety percent of cancer diagnoses are for solid tumors
and very few antibody-based therapies have been effective for these
cancers."
Mr. Junius continued, "Roche continues to make important progress with
trastuzumab emtansine, not only advancing it toward marketing
application submission this year, but also broadening the clinical
program to extend into early stage HER2+ breast cancer. At the same
time, we are making visible progress building and advancing our
proprietary product pipeline while other of our partners also are
advancing toward pivotal testing."
Product Pipeline Update
-
Lead compound trastuzumab emtansine, in development globally by Roche:
-
Most advanced indication — Positive results from Roche's first
trastuzumab emtansine Phase III trial, EMILIA, were presented at
the 2012 American Society of Clinical Oncology (ASCO) annual
meeting in the plenary session. EMILIA assessed trastuzumab
emtansine in patients with HER2+ metastatic breast cancer (BC) who
previously had been treated with Herceptin® (trastuzumab) and with
a taxane. Roche expects to apply in 2012 for marketing approval of
trastuzumab emtansine for this use in the US and Europe.
-
First-line for HER2+ metastatic BC — Patient enrollment has
completed in the Phase III trial, MARIANNE, evaluating trastuzumab
emtansine for this use. Roche expects to use this trial to apply
in 2014 for marketing approval of trastuzumab emtansine for the
first-line treatment of this cancer in the US and Europe.
-
For early stage HER2+ BC — In early June, Roche outlined its plans
to initiate three more trastuzumab emtansine registration trials
in 2013, evaluating the compound for neoadjuvant use, for adjuvant
use and to treat residual invasive disease following surgery. It
anticipates having pathological complete response (pCR) data from
the neoadjuvant trial during 2015.
-
IMGN901, ImmunoGen's lead wholly owned compound:
-
For first-line treatment of small-cell lung cancer (SCLC) —
Patient enrollment is ongoing in the NORTH Phase II trial, with 28
sites now open. The Company expects to be able to use this trial
to make the decisions necessary to advance IMGN901 into pivotal
testing.
Additionally, ImmunoGen expects to report
clinical findings on the IMGN901 dose established for use in
combination with etoposide/carboplatin at the Chicago
Multidisciplinary Symposium in Thoracic Oncology in early
September. The patient population for this Phase I evaluation was
not limited to first-line SCLC.
-
For relapsed multiple myeloma — The Company expects to report
findings from the Phase I trial assessing IMGN901 used in
combination with Revlimid® (lenalidomide)/ dexamethasone at a
medical conference in late 2012.
-
IMGN853, ImmunoGen's wholly owned folate receptor α (FOLR)-targeting
TAP compound, began clinical testing in June 2012. Its Phase I trial
is designed to first define IMGN853's maximum tolerated dose and
dose-limiting toxicity and then to evaluate it to treat specific types
of FOLR-overexpressing cancers. ImmunoGen expects to be able to use
this trial to make the decisions necessary to advance IMGN853 into
pivotal testing.
-
IMGN529, ImmunoGen's wholly owned TAP compound for the treatment of
CD37+ hematologic malignancies, entered clinical testing in April 2012
for the treatment of previously treated non-Hodgkin's lymphoma. The
Company expects to report the first clinical data with IMGN529 in 2013.
-
Other clinical-stage compounds — In addition to trastuzumab emtansine,
seven other compounds are in clinical testing through ImmunoGen's
collaborative partnerships.
-
The Company expects up to three of these compounds to advance into
pivotal testing by late 2013.
-
SAR3419 — Encouraging Phase I data were reported with SAR3419 at
ASCO. ImmunoGen believes the first Phase II data with this
CD19-targeting TAP compound could be presented at a medical
meeting in late 2012.
Fiscal Year 2012 Financial Results
For the Company's fiscal year ended June 30, 2012 (FY2012), ImmunoGen
reported a net loss of $73.3 million, or $0.95 per basic and diluted
share, compared to a net loss of $58.3 million, or $0.85 per basic and
diluted share, for its fiscal year ended June 30, 2011 (FY2011). For the
quarter ending June 30, 2012, ImmunoGen reported a net loss of $22.4
million, or $0.29 per basic and diluted share, compared to a net loss of
$16.2 million, or $0.23 per basic and diluted share, for the same
quarter in FY2011.
Revenues in FY2012 were $16.4 million, compared to $19.3 million in
FY2011. Revenues in FY2012 include $9.2 million of license and milestone
fees compared to $6.4 million in FY2011. The FY2012 fees include $5.0
million in milestone payments earned with partner advancement of one TAP
compound into Phase II clinical testing and two TAP compounds to Phase I
clinical testing. The FY2011 fees include $3.0 million in milestone
payments earned with partner advancement of two TAP compounds to Phase I
clinical testing. Revenues in FY2012 also include $4.5 million of
research and development support fees and $2.7 million of clinical
materials revenue, compared to $7.3 million and $5.7 million,
respectively, for FY2011. The differences in support fees and clinical
material revenue from the prior year are primarily due to the variable
nature in the amount of research and in the number of clinical batches
produced and released for partners on a year-to-year basis.
Operating expenses in FY2012 were $89.6 million, compared to $79.5
million in FY2011. Operating expenses in FY2012 include research and
development expenses of $69.2 million, compared to $63.5 million in
FY2011. This increase is primarily due to greater investment by the
Company in aggressively advancing its wholly owned product candidates.
It includes increased personnel expenses — including increased stock
compensation expense — in support of internal programs, partially offset
by a net reduction in expenses associated with providing partners with
clinical batches. Operating expenses also include general and
administrative expenses of $20.4 million in FY2012, compared to $16.0
million in FY2011. This increase is primarily due to increased personnel
expenses, particularly stock compensation expense.
Other (expense) income, net, was $(62,000) in FY2012, compared to $1.9
million in FY2011. Other income in FY2011 included $1.2 million of
federal grant funding the Company was awarded under the Patient
Protection and Affordable Care Act of 2010 to develop new anticancer
therapies and $0.3 million of gains recognized on sales of investments.
Cash used in operations was $34.3 million in FY2012, inclusive of the
$20 million upfront payment from the collaboration established with Eli
Lilly in the second quarter of FY2012. This compares with $8.0 million
of cash used in operations in FY2011, inclusive of the $45 million
upfront payment from the collaboration established with Novartis in the
second quarter of FY2011. Capital expenditures were $2.9 million and
$2.0 million for FY2012 and FY2011, respectively.
ImmunoGen had approximately $160.9 million in cash and cash equivalents
as of June 30, 2012, compared with $191.2 million as of June 30, 2011
and had no debt outstanding in either period. Not included in the June
30, 2012 cash and cash equivalents are the approximately $94 million in
net proceeds from the Company's recent public stock offering.
Financial Guidance for FY 2013
ImmunoGen expects its net loss for its fiscal year ending June 30, 2013
to be between $70 million to $74 million, its 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 marketable securities at
June 30, 2013 are anticipated to be between $172 million to $176
million, inclusive of the net proceeds from the public stock offering
recently completed.
"Roche, Sanofi and the rest of our partners are making tangible progress
with compounds that can generate meaningful revenue to ImmunoGen,"
commented Gregory Perry, Executive Vice President and CFO. "Our strong
financial position enables us to aggressively fund advancement of our
wholly owned compounds to further enhance shareholder value."
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
913-312-1510. Passcode is 6959547. 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 August 17, 2012.
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-killing agents specifically to tumor cells. There are
now ten TAP compounds in clinical development, of which three are wholly
owned by the Company. ImmunoGen's collaborative partners include Amgen,
Bayer HealthCare, Biotest, Lilly, Novartis, Roche, and Sanofi. The most
advanced compound using ImmunoGen's TAP technology, trastuzumab
emtansine, 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.
Herceptin® is a registered trademark of Genentech.
Revlimid® is a
registered trademark of Celgene 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, 2011 and other reports filed with the Securities and Exchange
Commission.
|
IMMUNOGEN, INC.
|
|
SELECTED FINANCIAL INFORMATION
|
|
(in thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2012
|
|
2011
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
$
|
160,938
|
|
|
$
|
191,206
|
|
|
|
|
|
|
|
|
Other assets
|
|
|
|
|
|
19,370
|
|
|
|
26,435
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
|
|
$
|
180,308
|
|
|
$
|
217,641
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
$
|
16,254
|
|
|
$
|
14,566
|
|
|
|
|
|
|
|
|
Long-term portion of deferred revenue and other long-term liabilities
|
|
|
80,164
|
|
|
|
63,106
|
|
|
|
|
|
|
|
|
Shareholders' equity
|
|
|
|
|
83,890
|
|
|
|
139,969
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders' equity
|
|
$
|
180,308
|
|
|
$
|
217,641
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
(Unaudited)
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Fiscal Year Ended
|
|
|
|
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
|
|
|
|
|
2012
|
|
|
|
2011
|
|
|
|
2012
|
|
|
|
2011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development support
|
|
$
|
1,184
|
|
|
$
|
1,566
|
|
|
$
|
4,517
|
|
|
$
|
7,256
|
|
|
License and milestone fees
|
|
|
|
950
|
|
|
|
2,859
|
|
|
|
9,161
|
|
|
|
6,393
|
|
|
Clinical materials revenue
|
|
|
|
818
|
|
|
|
2,080
|
|
|
|
2,679
|
|
|
|
5,656
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
|
|
2,952
|
|
|
|
6,505
|
|
|
|
16,357
|
|
|
|
19,305
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
19,539
|
|
|
|
18,261
|
|
|
|
69,192
|
|
|
|
63,453
|
|
|
General and administrative
|
|
|
5,726
|
|
|
|
4,438
|
|
|
|
20,422
|
|
|
|
16,040
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
25,265
|
|
|
|
22,699
|
|
|
|
89,614
|
|
|
|
79,493
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
|
|
(22,313
|
)
|
|
|
(16,194
|
)
|
|
|
(73,257
|
)
|
|
|
(60,188
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (expense) income, net
|
|
|
(101
|
)
|
|
|
44
|
|
|
|
(62
|
)
|
|
|
1,914
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
$
|
(22,414
|
)
|
|
$
|
(16,150
|
)
|
|
$
|
(73,319
|
)
|
|
$
|
(58,274
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted
|
|
$
|
(0.29
|
)
|
|
$
|
(0.23
|
)
|
|
$
|
(0.95
|
)
|
|
$
|
(0.85
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding, basic and diluted
|
|
|
77,416
|
|
|
|
71,315
|
|
|
|
76,814
|
|
|
|
68,919
|
|
For Investors:
ImmunoGen, Inc.
Carol Hausner, 781-895-0600
Executive
Director, Investor Relations and Corporate Communications
info@immunogen.com
or
For
Media:
The Yates Network
Barbara Yates, 781-258-6153
Source: ImmunoGen, Inc.
News Provided by Acquire Media
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