Company Provides Business Update and Fiscal Year 2009 Financial
Guidance
WALTHAM, Mass.--(BUSINESS WIRE)--Aug. 7, 2008--ImmunoGen, Inc.
(Nasdaq: IMGN), a biopharmaceutical company that develops targeted
anticancer therapeutics using its Tumor-Activated Prodrug (TAP)
technology, today announced financial results for the three-month
period and fiscal year ended June 30, 2008.
"The progress being made by us and our collaborators became more
visible this past year and we expect it to gain increased momentum
over the next twelve months," commented Mitchel Sayare, Chairman and
CEO. "We've reported encouraging initial clinical findings with
IMGN242 and IMGN901, and in July we advanced our third TAP compound,
IMGN388, into clinical testing. Genentech outlined a broad development
plan for trastuzumab-DM1 in their last quarterly call and now expects
to report the first Phase II findings with this TAP compound next
month. Our other collaborators - sanofi-aventis, Biogen Idec and
Biotest - also have had notable product achievements. We recently
unveiled another cutting-edge expansion of our technology portfolio -
new linkers designed specifically for multi-drug resistant cancers. We
expect to report other technology innovations in the coming year, as
well as more additions to our product portfolio."
Recent Corporate Highlights
- Genentech reported encouraging trastuzumab-DM1 (T-DM1) Phase I
data at the American Society of Clinical Oncology (ASCO)
annual meeting in June 2008 and in July 2008 disclosed its
intention to report interim Phase II data at the ASCO Breast
Cancer Symposium in September 2008;
- Promising clinical findings also were reported at the ASCO
annual meeting for IMGN242, in development by ImmunoGen and
for AVE1642, in development by collaborator sanofi-aventis;
- Genentech discussed in July 2008 its intention to evaluate
T-DM1 as a first-line treatment and as a third-line treatment
for HER2-positive metastatic breast cancer in Phase II
clinical trials, and that it plans to make a Phase III
decision in 2008 related to potentially also evaluating T-DM1
as a second-line treatment for this cancer;
- ImmunoGen further refined the next steps in the clinical
evaluation of IMGN901 for the treatment of multiple myeloma;
- TAP compounds IMGN388 and BIIB015 advanced into clinical
testing by ImmunoGen and by its collaborator Biogen Idec,
respectively;
- ImmunoGen unveiled innovations in its technology expected to
further expand the opportunity for TAP compounds; and
- The Company raised $25 million in June 2008 through the sale
of common stock to a single buyer.
Financial Results
For the three-month period ended June 30, 2008, ImmunoGen reported
a net loss of $11.9 million, or $0.27 per basic and diluted share,
compared to a net loss of $4.5 million, or $0.11 per basic and diluted
share, for the same period last year. For the fiscal year ended June
30, 2008, ImmunoGen reported a net loss of $32.0 million, or $0.75 per
basic and diluted share, compared to a net loss of $19.0 million, or
$0.45 per basic and diluted share, for the fiscal year ended June 30,
2007.
Revenues for the three-month period ended June 30, 2008 were $4.5
million, compared to $8.5 million for the same quarter last year.
Fourth quarter fiscal 2008 revenues include $3.4 million of research
and development support fees, compared to $6.8 million for the same
period last year. Research and development support fees primarily
represent funding earned pursuant to ImmunoGen's discovery,
development and commercialization collaboration with sanofi-aventis
and, to a lesser extent, funding earned under the Company's
development and license agreements with other of its collaborative
partners. The fifth and final contract year with sanofi-aventis began
in September 2007 and provides for reduced research and development
support fees compared with the previous contract year as ongoing
development activity is transitioned to sanofi-aventis. Fourth quarter
fiscal 2008 revenues also include $1.1 million of license and
milestone fees, compared to $1.3 million for the same quarter last
year and $49,000 of clinical material reimbursement, compared to
$0.5 million for the same quarter last year. ImmunoGen manufactures
clinical materials on behalf of its collaborators and, as needed, also
supplies its collaborators with the Company's cytotoxic agents (DM1
and DM4) in support of their manufacturing and development efforts,
and earns clinical material reimbursement revenue with the supply of
these materials to those collaborators.
Revenues for the fiscal year ended June 30, 2008 were $40.2
million, compared to $38.2 million for the fiscal year ended June 30,
2007. Revenues for the 2008 fiscal year include $15.0 million of
research and development support fees, compared to $25.5 million for
the same period last year. The significant decrease is primarily due
to reduced research and development support fees earned pursuant to
the discovery, development and commercialization collaboration with
sanofi-aventis, as noted above. During the 2007 fiscal year, ImmunoGen
also earned more in research and development support fees pursuant to
agreements with other of its collaborators as compared to the current
year. Revenues for the 2008 fiscal year include $13.2 million of
license and milestone fees, compared to $7.6 million for fiscal 2007.
Included in license and milestone fees for the 2008 fiscal year is a
$5.0 million milestone related to the initiation of Phase II clinical
testing of T-DM1 by Genentech, a $1.5 million milestone related to the
submission by Biogen Idec of the Investigational New Drug (IND)
application for BIIB015 to the US Food and Drug Administration (FDA)
and a $1.0 million milestone related to the initiation of Phase I
testing of SAR3419 by sanofi-aventis. Included in license and
milestone fees for the 2007 fiscal year is a $2.0 million milestone
payment related to the initiation of Phase I testing of AVE1642 by
sanofi-aventis. Revenues for the 2008 fiscal year also include $12.1
million of clinical material reimbursement, compared to $5.1 million
for fiscal 2007. The greater clinical material reimbursement revenue
for fiscal 2008 compared with fiscal 2007 is primarily due to
$5.0 million in revenue recognized by the Company for providing one of
its cytotoxic agents to a collaborator as well as to an increase in
the amount of clinical material supplied to collaborators.
Operating expenses for the three-month period ended June 30, 2008
were $16.5 million, compared to $13.8 million in the same period last
year. The operating expenses in the fourth quarter of fiscal 2008
include research and development expenses of $12.7 million, compared
to $11.0 million for the same quarter last year. The increase in
research and development expenses for the quarter ended June 30, 2008
versus the prior-year period is primarily due to increased antibody
supply costs and also to development costs incurred with contract
manufacturing organizations related to the potential production of
later-stage materials. Clinical trial costs also increased by $0.9
million during the 2008 period compared to the same period last year
due to costs associated with the start of IMGN388 clinical testing.
This includes a $0.5 million milestone expense ImmunoGen incurred to a
third party related to the advancement of IMGN388 to clinical stage.
Fourth quarter fiscal 2008 operating expenses also include general and
administrative expenses of $3.7 million, compared to $2.8 million for
the same quarter last year. General and administrative expenses
increased primarily as a result of increases in patent costs,
personnel costs and expenses related to the move of the Company to
Waltham, MA.
Operating expenses for the fiscal year ended June 30, 2008 were
$74.4 million, compared to $60.4 million for the fiscal year ended
June 30, 2007. Included in the operating expenses for fiscal 2008 are
research and development expenses of $60.0 million, compared to $49.4
million for the 2007 fiscal year. The increase in research and
development expense for fiscal 2008 compared to the prior year is
primarily due to the cost of supplying one of ImmunoGen's cytotoxic
agents to a collaborator during the year, as previously discussed, and
the Company's purchase of DM1/DM4 during the third quarter. Operating
expenses for the 2008 fiscal year also include general and
administrative expenses of $14.3 million, compared to $11.0 million
for the 2007 fiscal year. During fiscal 2008, the Company recognized
$1.5 million of expense related to the rental of laboratory and office
space in Waltham prior to occupying this space in late March 2008, as
well as $0.8 million of move-related expenses, classifying such as
general and administrative expenses. General and administrative
expenses also were greater due to increases in costs associated with
personnel and patents.
Other income, net, consisting primarily of interest income, losses
realized on investments due to impairment and gains recognized on
forward contracts, was $0.1 million in the fourth quarter of fiscal
2008, compared to $0.8 million for the same period last year and was
$2.1 million in the fiscal year ended June 30, 2008, compared to
$3.3 million for the fiscal year ended June 30, 2007. Included in
other income, net, for the fourth quarter of fiscal 2008 and the year
ended fiscal 2008 was $0.3 million and $0.5 million, respectively, of
impairment charges on investments. No similar charges were incurred
during fiscal 2007.
ImmunoGen had approximately $47.9 million in cash and marketable
securities as of June 30, 2008 - inclusive of $25 million raised in
June 2008 through the sale of common equity to a single buyer -
compared with $59.7 million as of June 30, 2007 and had no debt
outstanding in either period. During fiscal 2008, cash used in
operations was $20.2 million, compared to $15.8 million in fiscal
2007. Capital expenditures were $18.0 million and $2.0 million for the
fiscal years ended June 30, 2008 and 2007, respectively. Capital
expenditures for the current year include $3.7 million for improvement
of the Company's capabilities at its manufacturing plant in Norwood,
MA and $10.3 million to build out the laboratory and office space at
the Waltham facility occupied by ImmunoGen in late March 2008. The
$10.3 million of leasehold improvements are being paid by the landlord
of the Waltham facility, with such reimbursements recorded as a
benefit to cash used in operations.
Financial Guidance
ImmunoGen expects the net loss for its fiscal year ending June 30,
2009 to be between $37-$40 million, cash used in operations to be
between $20-$23 million and capital expenditures of $1-$3 million.
"In our 2009 fiscal year, we expect to have lower cash use than in
2008 even though we'll be putting more resources behind our own
compounds," noted Daniel Junius, President and Chief Operating
Officer. "In this fiscal year, we anticipate that cash used in
operations will be at a level similar to our 2008 fiscal year and that
our capital expenditures will be substantially lower. The funded
research portion of our collaboration with sanofi-aventis will
conclude as scheduled at the end of this month, causing an expected
decrease in our total projected revenues and thus an increase in our
projected net loss. The impact of the conclusion of this funding on
our cash position, however, is expected to be offset by lower
operating expenses, reduced capital spending and increases in other
collaborator activity."
Collaboration with sanofi-aventis
As previously disclosed, the research portion of Company's
collaboration with sanofi-aventis is scheduled to conclude on August
31, 2008 as no further extension is allowed under the agreement
entered into by the companies in July 2003.
After August 31, 2008, ImmunoGen will continue to be entitled to
receive milestone payments and royalties on the many compounds
developed under this collaboration, to receive manufacturing payments
on materials produced on behalf of sanofi-aventis, to receive
financial compensation for further research conducted on behalf of
sanofi-aventis and to have the co-promotion rights established in the
2003 agreement.
Sanofi-aventis' right to license non-exclusive use of ImmunoGen's
humanization technology for targets not included in the collaboration
also remains in effect after August 31, 2008. However, its option to
enter into an agreement with ImmunoGen for the right to test the
Company's TAP technology with antibodies to targets not included in
the collaboration will expire on August 31, 2008 if not exercised
before then.
Update on ImmunoGen Clinical-Stage Compounds
IMGN901
This TAP compound is in development for the treatment of
CD56-expressing multiple myeloma and solid tumors. Three IMGN901
trials are underway - Study 001 in small-cell lung cancer and the
dose-escalation trials Study 002 and Study 003 in CD56-expressing
solid tumors and multiple myeloma, respectively.
- ImmunoGen expects to report additional clinical findings for
both multiple myeloma and solid tumors in the fourth quarter
of 2008.
- Once the maximum tolerated dose (MTD) is established in Study
003, up to 15 patients will be treated at this MTD to gain
additional information on the activity of IMGN901 as
monotherapy against highly treatment-resistant multiple
myeloma.
- In light of the market trend toward treating multiple myeloma
with combination therapy, ImmunoGen plans to initiate a Phase
I/II trial to evaluate IMGN901 in combination with an approved
therapeutic after its MTD as monotherapy is established.
IMGN242
IMGN242 is in Phase II testing (Study 102) for the treatment of
CanAg-expressing gastric cancer. Additional cancers that express the
target of this TAP compound include pancreatic, colorectal and other
gastrointestinal tumors. The poster presented at the ASCO annual
meeting in June 2008 described one of the first patients treated with
IMGN242 in Study 102 who had a marked response to treatment. Patient
enrollment is ongoing in this study.
- The Company expects to report additional findings with IMGN242
in the fourth quarter of 2008.
- ImmunoGen intends to complete enrollment of the first 23
patients in this study during its fiscal year ending June 30,
2009.
IMGN388
Patient dosing with IMGN388 began in early July 2008. The integrin
target for this TAP compound is found on many types of solid tumors -
melanomas, sarcomas and numerous carcinomas - and also on endothelial
cells in the process of forming the new blood vessels that all solid
tumors need to grow.
- ImmunoGen expects to report initial Phase I clinical findings
in 2009.
Update on Collaborator Clinical-Stage Compounds
Genentech: T-DM1
T-DM1 comprises ImmunoGen's DM1 cell-killing agent linked to
Genentech's anti-HER2 antibody, trastuzumab. Genentech reported
encouraging T-DM1 Phase I data at the ASCO annual meeting in June
2008. T-DM1 is currently in Phase II testing for the treatment of
HER2-expressing metastatic breast cancer.
Genentech has disclosed that patient enrollment has completed
in the Phase II study that was started in mid-2007 to evaluate
T-DM1 in patients whose HER2-expressing metastatic breast
cancer progressed on HER2-directed therapy ("second-line plus"
treatment). Genentech has reported that it expects to submit
an abstract for presentation of interim data from this study
at the ASCO Breast Cancer Symposium being held September 5-7,
2008 in Washington, DC.
Genentech has reported that it plans to initiate two
additional T-DM1 Phase II trials in the second half of 2008.
One of these trials is designed to evaluate T-DM1 as
monotherapy compared with Herceptin (trastuzumab) plus
docetaxel as a first-line treatment for HER2-positive
metastatic breast cancer. The other trial is to evaluate T-DM1
as a third-line treatment for this cancer. Genentech has
disclosed that if the results of the third-line study are
compelling, the company will discuss an earlier approval
pathway with the FDA.
Genentech has disclosed that it plans to make a Phase III
decision in 2008 related to potentially also evaluating T-DM1
as a second-line treatment for HER2-positive metastatic breast
cancer.
sanofi-aventis: AVE1642, AVE9633, SAR3419
AVE1642 is a non-conjugated or "naked" antibody in development by
sanofi-aventis for the treatment of solid and liquid tumors. This
compound is designed for use in combination with chemotherapy, and the
first clinical data on its safety and activity with a chemotherapeutic
agent - docetaxel - were reported at the ASCO meeting in June 2008.
AVE1642 was found to be well tolerated and evidence of anticancer
activity was reported. Trials are planned or underway to study AVE1642
in combination with an array of chemotherapy agents for the treatment
of many different types of cancers.
The TAP compounds AVE9633 and SAR3419 are in Phase I testing for
the treatment of acute myeloid leukemia and non-Hodgkin's lymphoma,
respectively.
-
ImmunoGen expects the first SAR3419 clinical data to be
reported in late 2008.
Biogen Idec: BIIB015
This TAP compound advanced into clinical testing in mid-2008 and
is a potential new treatment for solid tumors.
Biotest: BT062
The TAP compound BT062 is expected to begin clinical testing this
summer and is a potential new treatment for multiple myeloma.
Technology Update
ImmunoGen's TAP technology is attracting attention because of the
activity seen against treatment-resistant tumors and also because of
the excellent tolerability documented at doses substantially greater
than those able to be administered with other technologies. ImmunoGen
credits these benefits to the qualities of its cell-killing agents and
linkers.
ImmunoGen recently unveiled additional linkers developed by the
Company to provide enhanced activity against multi-drug resistant
cancer cells. These proprietary linkers also are expected to expand
the opportunity for TAP compounds for targets that are expressed at a
low density on the cancer cell. ImmunoGen is committed to maintaining
its leadership position in its field.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using
its expertise in cancer biology, monoclonal antibodies and the
creation and attachment of potent cell-killing agents. The Company's
TAP technology uses antibodies to deliver one of ImmunoGen's
proprietary cell-killing agents specifically to cancer targets. In
addition to the Company's proprietary clinical pipeline, ImmunoGen
collaborators Genentech, sanofi-aventis and Biogen Idec also are
testing TAP compounds in the clinic, and a naked antibody is in
clinical trials through the Company's collaboration with
sanofi-aventis.
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: its expected net
loss, cash used in operations and capital expenditures in its 2009
fiscal year and the anticipated changes in operating expenses, capital
spending, and collaborator activity; the Company's and its
collaboration partners' clinical trial activity and presentation of
clinical data; the Company's technology innovations; the momentum of
progress over the next twelve months; and to other events related to
the Company's product portfolio. 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
outcome of ImmunoGen's research and clinical development processes;
the outcome of ImmunoGen'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 and clinical
trials; ImmunoGen's ability to financially support its product
programs; ImmunoGen's dependence on collaborative partners; and other
factors more fully described in ImmunoGen's Annual Report on Form 10-K
for the fiscal year ended June 30, 2007 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,
2008 2007
--------- --------
ASSETS
Cash and marketable securities $ 47,871 $59,700
Other assets 35,467 20,721
--------- --------
Total assets $ 83,338 $80,421
========= ========
LIABILITIES AND SHAREHOLDERS'
EQUITY
Current liabilities $ 10,386 $14,288
Long-term portion of deferred
revenue and other long-term
liabilities 17,653 7,732
Shareholders' equity 55,299 58,401
--------- --------
Total liabilities
and shareholders'
equity $ 83,338 $80,421
========= ========
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended Year Ended
June 30, June 30,
------------------ -------------------
2008 2007 2008 2007
------------------ -------------------
Revenues:
Research and development
support $ 3,374 $ 6,803 $ 15,035 $ 25,486
License and milestone fees 1,060 1,254 13,156 7,585
Clinical materials
reimbursement 49 477 12,058 5,141
-------- ------- -------- --------
Total revenues 4,483 8,534 40,249 38,212
-------- ------- -------- --------
Expenses:
Research and development 12,739 11,028 60,013 49,409
General and administrative 3,722 2,818 14,348 11,029
--------- -------- --------- ---------
Total operating expenses 16,461 13,846 74,361 60,438
--------- -------- --------- ---------
Loss from operations (11,978) (5,312) (34,112) (22,226)
Other income, net 55 790 2,119 3,274
--------- -------- --------- ---------
Loss before taxes (11,923) (4,522) (31,993) (18,952)
Income tax expense 5 7 27 35
--------- -------- --------- ---------
Net loss $(11,928) $(4,529) $(32,020) $(18,987)
========= ======== ========= =========
Net loss per common share,
basic and diluted $ (0.27) $ (0.11) $ (0.75) $ (0.45)
========= ======== ========= =========
Average common shares
outstanding, basic and diluted 43,863 42,282 42,969 41,759
========= ======== ========= =========
CONTACT:
Investors:
ImmunoGen, Inc.
Carol Hausner, 781-895-0600
Executive Director, Investor Relations and
Corporate Communications
info@immunogen.com
Media:
KMorrisPR
Kathryn Morris, 845-635-9828
Kathryn@kmorrispr.com
