ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that
develops targeted anticancer products using its antibody expertise
and Targeted Antibody Payload (TAP) technology, today announced
financial results for the three-month period and fiscal year ended
June 30, 2010.
“We’re starting our new fiscal year with ImmunoGen in a very
strong position,” commented Daniel Junius, President and CEO. “The
first marketing application for an anticancer compound using our
TAP technology – T-DM1 – is at the FDA. We’re aggressively
advancing our own product candidates, with our third compound on
track to enter the clinic in 2011. Five clinical-stage product
candidates are moving forward through our collaborative partners
with another expected to enter the clinic in 2010 and up to three
more expected in the clinic in 2011. We have a solid management
team and a strong balance sheet, and are seeing a whole new level
of interest in our technology by other companies.”
Product Pipeline Highlights
Trastuzumab-DM1 (T-DM1) – in development by Roche for treatment
of advanced HER2+ breast cancer (BC)
- Marketing application submitted
in July 2010 to US FDA for treatment of advanced HER2+ BC
previously treated with multiple HER2-targeted medicines and
chemotherapies. Roche is seeking accelerated approval for this
marketing application.
- Phase III MARIANNE trial
initiated in July 2010 assessing T-DM1 for 1st-line treatment of
advanced HER2+ BC.
- Preliminary data from Phase II
study assessing T-DM1 for 1st-line treatment of advanced HER2+ BC
have been accepted for presentation at ESMO in October 2010.
- Over 185 clinical sites are now
participating in the Phase III EMILIA trial assessing T–DM1 for
2nd-line treatment of advanced HER2+ BC.
- Additional data from trial
assessing T-DM1 used with pertuzumab have been submitted for
presentation at SABCS in December 2010.
Lorvotuzumab mertansine (IMGN901) – in development by ImmunoGen
for treatment of CD56+ solid tumors and multiple myeloma
- Updated clinical data have been
accepted for presentation at ESMO in October 2010 from a trial
assessing this compound for the treatment of advanced small-cell
lung cancer (SCLC), Merkel cell carcinoma (MCC) and ovarian
cancer.
- Trial assessing this compound
for 1st-line treatment of SCLC is on track to be initiated by late
2010. Orphan drug status for SCLC has been applied for in the US
and Europe.
- A go/no go decision on the
initiation of a pivotal trial in MCC is expected to be made by
ImmunoGen by the end of 2010. Orphan drug status for MCC has been
granted in the US and Europe.
- Updated clinical data from one
or both of the ongoing trials assessing the compound for multiple
myeloma are expected to be submitted for presentation at ASH in
December 2010.
SAR3419 – in development by sanofi-aventis for treatment of
non-Hodgkin’s lymphoma
- Impressive results have been
seen in the Phase I weekly dosing study and the “go” decision has
been made to advance SAR3419 into Phase II. This testing is
expected to start in 2H2011, with the Phase I data reported at ASH
in 2011.
IMGN388 – in development by ImmunoGen for treatment of solid
tumors
- Updated Phase I clinical
findings with IMGN388 have been accepted for presentation at the
EORTC-NCI-AACR meeting in November 2010. Dose-escalation has been
completed in the part of this study assessing dosing IMGN388 every
three weeks.
Other ImmunoGen Compounds
- ImmunoGen expects to submit an
IND for the Company’s third compound, IMGN529, in 2011 and one for
its fourth compound in 2012. These are both TAP compounds.
Other Partner Compounds
- BT-062 and BIIB015 continue to
progress in Phase I testing, and ImmunoGen expects that clinical
data could be reported for one or both of these compounds in late
2010.
- SAR650984 advanced into clinical
testing in June 2010 through the Company’s collaboration with
sanofi-aventis. ImmunoGen expects another compound to enter the
clinic in 2010 through this collaboration.
- ImmunoGen expects 2-3 additional
compounds to enter the clinic in 2011 through the Company’s
collaborative partners.
Financial Results
ImmunoGen reported a net loss of $13.4 million, or $0.21 per
basic and diluted share, for the three-month period ended June 30,
2010, compared to a net loss of $10.8 million, or $0.21 per basic
and diluted share, for the same period last year. For the Company’s
fiscal year ended June 30, 2010 (FY2010), ImmunoGen reported a net
loss of $50.9 million, or $0.87 per basic and diluted share,
compared to a net loss of $31.9 million, or $0.63 per basic and
diluted share, for its fiscal year ended June 30, 2009
(FY2009).
Revenues were $13.9 million in FY2010, compared to
$28.0 million in FY2009. Revenues in FY2010 include $5.7
million of license and milestone fees, compared to
$15.1 million in FY2009. The FY2010 fees include $2.5 million
in milestone payments earned with early-stage product achievements
by two collaborative partners. The FY2009 fees include
$10.5 million in milestone payments earned with two
collaboration compounds moving into more advanced clinical testing,
as well as other, smaller, items. Revenues in FY2010 also include
$5.4 million of research and development support fees,
compared to $7.6 million in FY2009. The FY2009 support fees
included the final committed funding earned from sanofi-aventis
under a five-year funded research collaboration between the
companies. Revenues in FY2010 also include $2.9 million of clinical
material reimbursement, compared to $5.3 million in FY2009. The
lower amount in FY2010 compared with FY2009 is primarily because
more clinical material batches were released in FY2009 than in
FY2010.
Operating expenses in FY2010 were $65.2 million, compared
to $59.8 million in FY2009. Operating expenses in FY2010 include
research and development expenses of $50.3 million and general
and administrative expenses of $14.9 million, compared to
$45.9 million and $13.9 million, respectively, in FY2009. The
increase in research and development expenses in FY2010 versus the
prior year is primarily due to increased clinical and preclinical
costs related to development of ImmunoGen product candidates,
increased salary and related expenses driven by additional
personnel and greater stock compensation expense, and less
manufacturing overhead being allocated to collaborative partners to
produce clinical materials on their behalf.
ImmunoGen had approximately $110.3 million in cash and
marketable securities as of June 30, 2010 – inclusive of net
proceeds of $77.5 million raised in May 2010 through the sale of
common equity through a public offering – compared with $71.1
million as of June 30, 2009. The Company had no debt
outstanding in either period. During FY2010, cash used in
operations was $40.6 million, compared to $13.3 million during
FY2009. The increase in cash used was driven principally by reduced
cash inflow from upfront and milestone payments in FY2010 compared
to FY2009, which also contributed to the greater net loss, and by
the timing of payment of incentive compensation. Capital
expenditures were $1.5 million for FY2010, compared to $1.9 million
for FY2009.
Financial Guidance
ImmunoGen expects its net loss for its fiscal year ending June
30, 2011 to be between $50-53 million, its cash used in operations
to be between $34-37 million, and its capital expenditures to be
between $2-3 million. Cash and marketable securities at June 30,
2011 are anticipated to be between $74-77 million.
“Our guidance for our 2011 fiscal year reflects the increased
investment we’re making in the aggressive development of our own
product pipeline, which is more than offset by the significant
increase in the amount of cash we expect to receive from partners,”
commented Gregory Perry, Senior Vice President and CFO. “In the
near term, we expect most of this cash inflow to be from upfront
and milestone payments, with the potential for us to begin
receiving royalty payments in the later part of our 2011 fiscal
year.”
About ImmunoGen’s Targeted Antibody Payload (TAP)
Technology
The Company’s TAP technology uses tumor-targeting manufactured
antibodies to deliver one of ImmunoGen’s proprietary, highly potent
cancer-cell killing agents specifically to cancer cells, to destroy
tumors while reducing the damage to healthy tissue seen with
non-targeted therapies. All of the TAP compounds in clinical
development by the Company and its collaborative partners use an
ImmunoGen cancer-cell killing agent (DM1, DM4) attached to the
antibody with an ImmunoGen linker and methods of attachment. The
benefits of ImmunoGen’s approach are seen in the growing body of
clinical data being reported on the many TAP compounds in
development for a wide variety of cancers.
About the Pipeline Compounds Discussed
T-DM1 is in global development by Roche under a collaboration
agreement between ImmunoGen and Genentech, a member of the Roche
Group. T-DM1 consists of Roche’s HER2-targeting antibody,
trastuzumab, with ImmunoGen’s DM1 cancer-cell killing agent
attached using ImmunoGen’s linker and methods of attachment.
Lorvotuzumab mertansine consists of DM1 attached to the
Company’s CD56-targeting antibody. It is wholly owned by ImmunoGen.
IMGN388 consists of the Company’s DM4 cell-killing agent attached
to an αv integrin-targeting antibody developed by Centocor
Ortho Biotech Inc., which has certain opt-in rights. IMGN529 is a
potential treatment for certain hematological malignancies.
SAR3419 and SAR650984 are in development by sanofi-aventis under
a license agreement with ImmunoGen. SAR3419 consists of a
CD19-targeting antibody developed and humanized by ImmunoGen with
DM4 attached. SAR650984 is a non-TAP antibody therapeutic for
hematological malignancies consisting of a CD38-targeting antibody
developed and humanized by ImmunoGen.
BT-062 and BIIB015 are in development by Biotest and Biogen
Idec, respectively, for the treatment of multiple myeloma and solid
tumors, respectively, under collaboration agreements with
ImmunoGen. ImmunoGen has certain opt-in rights to BT-062.
In addition to the compounds discussed above, companies that
have licenses to develop TAP compounds to one or more other
agreed-upon targets include Amgen, Bayer Schering Pharma,
Genentech/Roche, and sanofi-aventis.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using
its expertise in cancer biology, monoclonal antibodies and the
creation and attachment of potent cancer-cell killing agents. The
Company’s TAP technology uses engineered antibodies to deliver one
of ImmunoGen’s proprietary cancer-cell killing agents specifically
to tumor targets. In addition to the Company’s product pipeline,
compounds are in clinical testing through ImmunoGen’s
collaborations with Genentech (a member of the Roche Group),
sanofi-aventis, Biogen Idec and Biotest. A marketing application
for the most advanced compound using ImmunoGen’s TAP technology,
T-DM1, was submitted to the US FDA by Genentech in July 2010. Other
ImmunoGen collaborative partners include Bayer Schering Pharma AG
and Amgen. More information about ImmunoGen can be found at
www.immunogen.com.
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 2011 fiscal year; its cash and marketable
securities as of June 30, 2011; 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 timing and outcome of product development, regulatory and
business development events. 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 FDA reviews; 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, 2009 and other reports filed with the Securities and
Exchange Commission.
- Financials Follow -
IMMUNOGEN, INC. SELECTED FINANCIAL INFORMATION (in
thousands, except per share amounts)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited) June 30, June 30,
2010 2009 ASSETS Cash, cash equivalents and
marketable securities $ 110,298 $ 71,125 Other assets 26,910
29,579 Total assets $ 137,208 $
100,704 LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $ 13,822 $ 11,128 Long-term portion of deferred
revenue and other long-term liabilities 21,338 22,719 Shareholders'
equity 102,048 66,857 Total
liabilities and shareholders' equity $ 137,208 $ 100,704
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited) Three Months Ended Year
Ended June 30, June 30, 2010
2009 2010 2009 Revenues: License
and milestone fees $ 1,774 $ 814 $ 5,698 $ 15,117 Research and
development support 1,495 1,168 5,365 7,566 Clinical materials
reimbursement 1,153 2,320 2,880
5,305 Total revenues
4,422 4,302 13,943 27,988
Expenses: Research and development 13,790 11,663
50,280 45,904 General and administrative 3,973
3,458 14,898 13,900 Total
operating expenses 17,763 15,121
65,178 59,804 Loss from operations
(13,341 ) (10,819 ) (51,235 ) (31,816 ) Other (loss)/income,
net (64 ) (8 ) 58 (221 )
Loss before taxes (13,405 ) (10,827 ) (51,177 ) (32,037 )
(Benefit)/provision for income taxes - -
(265 ) (100 ) Net loss $ (13,405 ) $
(10,827 ) $ (50,912 ) $ (31,937 )
Net loss per common
share, basic and diluted $ (0.21 )
$ (0.21 ) $ (0.87 )
$ (0.63 ) Average common
shares outstanding, basic and diluted 63,851
51,635 58,845
51,068
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