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, 2011.
“Our product pipeline is both advancing and broadening,
increasingly through our own progress as well as through that of
our partners,” commented Daniel Junius, President and CEO.
“Trastuzumab emtansine, or T-DM1, continues to be the most advanced
compound, with Roche expecting to report data from the EMILIA Phase
III trial by mid-2012 and to apply for marketing approval in the US
and Europe soon after. We expect as many as three other TAP
compounds to have started Phase II testing by mid-2012, including
our wholly owned IMGN901 compound. We also expect five additional
TAP compounds to enter the clinic during this time period,
including our wholly owned IMGN529 and IMGN853 product
candidates.”
Clinical-Stage Product Candidates
Trastuzumab emtansine (T-DM1) – In global development by Roche
for the treatment of HER2+ breast cancer (BC) under a licensing
agreement with ImmunoGen.
- 2nd-line metastatic BC – Roche expects
to report data from the Phase III EMILIA trial by mid-2012 and to
apply in 2012 for marketing approval in the US and Europe.
- 1st-line metastatic BC – Mature data
from the completed Phase II trial have been submitted for
presentation at the ESMO annual meeting in September 2011. Roche
expects to apply for marketing approval for this use in 2014 with
data from the MARIANNE Phase III trial.
- Other – Roche initiated a Phase II
safety trial in the adjuvant/neoadjuvant BC setting in 4Q2010.
Separately, the compound was found to be active against gastric
cancer in several recently published preclinical studies.
Lorvotuzumab mertansine (IMGN901) – wholly owned ImmunoGen
product candidate for small-cell lung cancer (SCLC) and other CD56+
cancers.
- SCLC – Continued progress is being made
in the Phase I trial designed to establish the dose of IMGN901 plus
etoposide/carboplatin (E/C) to be used in later-stage clinical
testing. The Company expects to begin assessment of this
combination to treat newly diagnosed metastatic SCLC in a
randomized Phase II trial in late 2011/early 2012 and to report
initial data from that trial in 2H2012.
- Merkel cell carcinoma (MCC) – The
Company anticipates the IMGN901 plus E/C dose being established
could be used in an MCC pivotal trial should the Company determine
there is a benefit in aggressively developing IMGN901 for MCC as
well as for SCLC.
- Multiple myeloma – Positive data from a
Phase I trial evaluating the compound in combination with
lenalidomide (Revlimid®)/dexamethasone were presented at ASCO in
June 2011, and patient enrollment is underway in the expansion
phase of this study. The trial evaluating IMGN901 used alone to
treat this cancer has been completed.
SAR3419 – ImmunoGen-created CD19-targeting TAP compound in
development by Sanofi for non-Hodgkin’s lymphoma (NHL).
- Phase I clinical data were presented at
ASCO and in an oral presentation at the 11th International
Conference on Malignant Lymphoma in June 2011 that showed the
compound achieved a 33% objective response rate when given at its
maximum tolerated dose to patients with relapsed/refractory NHL.
SAR3419 demonstrated activity against rituximab
(Rituxan®)-resistant and -responsive disease and across
histological tumor types.
- Sanofi expects to begin Phase II
testing of SAR3419 in 2H2011. Its clinical program is designed to
support the rapid progression of the compound into pivotal
testing.
IMGN388, SAR650984, SAR566658 and BT-062 are progressing in
early-stage clinical testing through programs being implemented by
ImmunoGen, Sanofi (2), and Biotest, respectively. The IND for an
additional TAP compound, BAY 94-9343, has been submitted by Bayer
HealthCare Pharmaceuticals.
Lead Preclinical Product Candidates
The Company expects five additional TAP compounds to advance
into clinical testing in the coming months for a total of 13
compounds in clinical development by mid-2012.
IMGN529 – Wholly owned ImmunoGen product candidate for B-cell
malignancies such as NHL and chronic lymphocytic leukemia. IMGN529
uses the Company’s TAP technology with an antibody that has potent
anticancer activity of its own. The Company expects to submit the
IMGN529 IND in late 3Q2011.
IMGN853 – Wholly owned ImmunoGen product candidate for cancers
that over-express folate receptor 1, which include ovarian cancer.
IMGN853 uses an antibody selected by ImmunoGen scientists based on
its payload delivery proficiency and a new linker developed by the
Company to combat multi-drug resistance. The Company expects to
submit the IMGN853 IND in early 2012.
Three additional TAP compounds are expected to enter the clinic
by mid-2012 through ImmunoGen partners.
Fiscal Year 2011 Financial Results
For the Company’s fiscal year ended June 30, 2011 (FY2011),
ImmunoGen reported a net loss of $58.3 million, or $0.85 per basic
and diluted share, compared to a net loss of $50.9 million, or
$0.87 per basic and diluted share, for its fiscal year ended June
30, 2010 (FY2010). For the quarter ending June 30, 2011 (4QFY2011),
ImmunoGen reported a net loss of $16.2 million, or $0.23 per basic
and diluted share, compared to a net loss of $13.4 million, or
$0.21 per basic and diluted share, for the same quarter in
FY2010.
Revenues in FY2011 were $19.3 million, compared to
$13.9 million in FY2010. Revenues in FY2011 include $7.3
million of research and development support fees, compared to
$5.4 million in FY2010. This increase is driven by agreements
with partners entered into in FY2011 and FY2010. Revenues in FY2011
also include $6.4 million of license and milestone fees compared to
$5.7 million in FY2010. The FY2011 fees include $3.0 million
in milestone payments earned with the advancement of two TAP
compounds into clinical testing by collaborative partners. The
FY2010 fees include $2.5 million in milestone payments earned with
preclinical and early-stage clinical product achievements by two
collaborative partners. Revenues in FY2011 also include $5.7
million of clinical material reimbursement, compared to $2.9
million in FY2010. The increase is primarily due to an increase in
the number of clinical material batches released in FY2011 compared
with FY2010.
Operating expenses in FY2011 were $79.5 million, compared
to $65.2 million in FY2010. Operating expenses in FY2011 include
research and development expenses of $63.5 million, compared
to $50.3 million in FY2010. This increase is primarily due to
greater Company investment behind aggressively developing its own
product candidates, including costs associated with expanded
patient enrollment in clinical trials and the advancement of
IMGN529 and IMGN853 toward IND filing. It also includes increased
salary and related expenses driven by additional personnel and
greater stock compensation expense and by increased cost of
clinical materials reimbursed related to increased manufacturing on
behalf of our partners. General and administrative expenses
increased modestly between FY2010 and FY2011 – from $14.9 million
to $16.0 million, respectively – with the difference primarily
due to increased patent and personnel costs.
Other income (expense), net, was $1.9 million in FY2011,
compared to $58,000 in FY2010. Other income in FY2011 includes
$1.2 million of federal grant funding that the Company was
awarded in 2QFY2011. The Company had received $1.1 million of this
funding as of June 30, 2011.
ImmunoGen had approximately $191.2 million in cash, cash
equivalents and marketable securities as of June 30, 2011 –
inclusive of net proceeds of $88.0 million from a public offering
of common equity in 4QFY2011 – compared with $110.3 million as of
June 30, 2010; the Company had no debt outstanding in either
period. Cash used in operations was $8.0 million in FY2011,
compared with $40.6 million in FY2010. Cash used in operations in
FY2011 benefited from the $45 million upfront payment received from
Novartis in 2QFY2011. Capital expenditures were $2.0 million for
FY2011, compared to $1.5 million for FY2010.
Financial Guidance
ImmunoGen expects its net loss for its fiscal year ending June
30, 2012 to be between $65-70 million, its cash used in
operations to be between $60-65 million, and its capital
expenditures to be between $4-5 million. Cash and marketable
securities at June 30, 2012 are anticipated to be between $125-130
million.
“Our strong balance sheet enables us to aggressively advance our
own product candidates to value inflection points,” commented
Gregory Perry, Executive Vice President and CFO. “At the same time,
our partnerships are providing us with cash that partially funds
our investment in our product programs. We believe we have ample
liquidity to last us well past the commercialization of the first
TAP compound by our partners.”
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-cell killing agents specifically
to tumor cells. There are now numerous TAP compounds in clinical
development and a wealth of clinical data reported. ImmunoGen’s
collaborative partners include Amgen, Bayer HealthCare
Pharmaceuticals, Biotest, Novartis, Roche, and Sanofi. The most
advanced compound using ImmunoGen's TAP technology, trastuzumab
emtansine (T-DM1), 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.
Revlimid® is a registered trademark of Celgene Corporation.
Rituxan® is a registered trademark of Biogen Idec.
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 2012 fiscal year; its cash and marketable
securities as of June 30, 2012; 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, 2010 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,
2011 2010 ASSETS Cash, cash equivalents and
marketable securities $ 191,206 $ 110,298 Other assets
26,435 26,910 Total assets $ 217,641
$ 137,208 LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $ 14,566 $ 13,822 Long-term portion of
deferred revenue and other long-term liabilities 63,106 21,338
Shareholders' equity 139,969 102,048
Total liabilities and shareholders' equity $ 217,641
$ 137,208
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (Unaudited) Three
Months Ended Year Ended June 30, June 30,
2011 2010 2011
2010 Revenues: Research and development
support $ 1,566 $ 1,495 $ 7,256 $ 5,365 License and milestone fees
2,859 1,774 6,393 5,698 Clinical materials reimbursement
2,080 1,153 5,656 2,880
Total revenues 6,505
4,422 19,305 13,943
Expenses: Research and development 18,261 13,790 63,453 50,280
General and administrative 4,438 3,973
16,040 14,898 Total operating
expenses 22,699 17,763 79,493
65,178 Loss from operations (16,194 )
(13,341 ) (60,188 ) (51,235 ) Other income (expense), net
44 (64 ) 1,914 58
Loss before taxes (16,150 ) (13,405 ) (58,274 ) (51,177 )
Benefit for income taxes - -
- (265 ) Net loss $ (16,150 ) $ (13,405
) $ (58,274 ) $ (50,912 )
Net loss per common share,
basic and diluted $ (0.23 ) $
(0.21 ) $ (0.85 ) $
(0.87 ) Average common shares
outstanding, basic and diluted 71,315
63,851 68,919
58,845
ImmunoGen (NASDAQ:IMGN)
Historical Stock Chart
From Jun 2024 to Jul 2024
ImmunoGen (NASDAQ:IMGN)
Historical Stock Chart
From Jul 2023 to Jul 2024