–Company Reports Meaningful Pipeline Progress with Proprietary and
Partnered Product Candidates–
ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that
develops targeted anticancer therapeutics using its antibody expertise
and Targeted Antibody Payload (TAP) technology, today announced
financial results for the fiscal year and three-month period ended June
30, 2009.
“There are now multiple compounds in the clinic generating data
supportive of our TAP technology and the most advanced of these could
potentially gain marketing approval in 2010,” commented Daniel Junius,
President and Chief Executive Officer. “This progress enables us to
focus on building value through prompt advancement of our lead
compounds, further expansion of our pipeline of proprietary products and
leveraging our business development opportunities.”
Mr. Junius continued, “We’re now making clear progress with our IMGN901
compound – we recently reported encouraging new clinical data in solid
tumors and, in multiple myeloma, we’ve gained the dosing information
needed to expand our single agent trial and to move forward to starting
our combination trial. Our IMGN388 clinical trial also is proceeding at
a strong pace. At the same time, we’re using the findings in the clinic
with the lead TAP compounds – ours and our partners’ – to strengthen and
expand our pipeline of earlier-stage compounds. Our expanding pipeline,
together with our technology and expertise, provide us with a number of
possible business development opportunities, some potentially in
interesting new areas.”
Recent Highlights
-
Clinical data for trastuzumab-DM1 (T-DM1) as a third-line treatment1
for HER2-positive metastatic breast cancer are now expected to be
available in the fourth quarter of 2009 rather than in the first
quarter of 2010. Roche has indicated that, if compelling, these data
would be used to support a T-DM1 marketing application in the US in
2010.
-
Encouraging IMGN901 clinical findings in the treatment of small-cell
lung cancer, Merkel cell carcinoma, and other CD56-positive solid
tumors were reported at the 13th World Conference on Lung
Cancer.
-
The maximum tolerated dose of IMGN901 was established in patients with
multiple myeloma – an essential step to the initiation of its
evaluation as part of a combination regimen for this disease and also
to its expanded assessment as a single agent.
-
The first SAR3419 and BT-062 clinical data are expected to be reported
in the fourth quarter of 2009.
Financial Results
For the three-month period ended June 30, 2009, ImmunoGen reported a net
loss of $10.8 million, or $0.21 per basic and diluted share, compared to
a net loss of $11.9 million, or $0.27 per basic and diluted share, for
the same period last year. For the fiscal year ended June 30, 2009,
ImmunoGen reported a net loss of $31.9 million, or $0.63 per basic and
diluted share, compared to a net loss of $32.0 million, or $0.75 per
basic and diluted share, for the fiscal year ended June 30, 2008.
For the fiscal year ended June 30, 2009, revenues were $28.0 million,
compared to $40.2 million for the fiscal year ended June 30, 2008.
Revenues for the 2009 fiscal year include $15.1 million of license and
milestone fees, compared to $13.2 million for fiscal 2008. The license
and milestone fees for the 2009 fiscal year include a $6.5 million
milestone payment earned from Genentech with the start of T-DM1 Phase
III testing and a $4.0 million milestone payment earned with
sanofi-aventis’ initiation of AVE1642 Phase II testing as well as other,
smaller, items. The license and milestone fees for the 2008 fiscal year
include a total of $8.5 million in milestone payments earned across
several collaborative partners. Revenues for the 2009 fiscal year also
include $5.3 million of clinical material reimbursement, compared to
$12.1 million for fiscal 2008. The lower amount for fiscal 2009 compared
with fiscal 2008 is primarily because in fiscal 2008 this revenue
included $5.0 million associated with the Company supplying a
collaborator with one of its cytotoxic agents and because more clinical
material batches were released in fiscal 2008 than in fiscal 2009.
Revenues for the 2009 fiscal year also include $7.6 million of research
and development support fees, compared to $15.0 million for fiscal 2008.
The decreased funding in the current year compared to the prior year is
primarily due to a reduction in the amount earned from sanofi-aventis
with the conclusion of its committed funding obligations in calendar
2008.
Operating expenses for the fiscal year ended June 30, 2009 were
$59.8 million, compared to $74.4 million for the fiscal year ended June
30, 2008. Operating expenses for the 2009 fiscal year include research
and development expenses of $45.9 million, compared to $60.0 million for
fiscal 2008. The decrease in research and development expenses for
fiscal 2009 versus the prior year is primarily due to reduced cost of
clinical materials reimbursed, decreased antibody development and supply
costs, and reduced development costs incurred with contract
manufacturing organizations related to the potential production of
later-stage materials, partially offset by greater salaries and related
expenses and by lower overhead utilization. Operating expenses for the
2009 fiscal year also include general and administrative expenses of
$13.9 million, compared to $14.3 million for the 2008 fiscal year.
Other (expense)/income, net, consisting primarily of interest income,
(losses)/gains recognized on forward contracts and losses realized on
investments due to impairment, was $(0.2) million in the fiscal year
ended June 30, 2009, compared to $2.1 million for the fiscal year ended
June 30, 2008. Included in other (expense)/income, net, was $0.6 million
and $2.2 million of interest income and $(0.2) million and $0.7 million
of (losses)/gains recognized on forward contracts for fiscal 2009 and
2008, respectively. Losses realized on investments due to impairment
were ($0.5) million in both years.
ImmunoGen had approximately $71.1 million in cash and marketable
securities as of June 30, 2009, inclusive of net proceeds of $38.0
million raised in June 2009 with the sale of common equity through a
public offering, compared with $47.9 million as of June 30, 2008. The
Company had no debt outstanding in either period. During fiscal 2009,
cash used in operations was $13.3 million, compared to $20.1 million in
fiscal 2008. Proceeds from the landlord for a tenant allowance benefited
these amounts in fiscal 2009 and 2008 by $0.8 million and $10.0 million,
respectively. Capital expenditures were $1.9 million and $18.0 million
for the fiscal years ended June 30, 2009 and 2008, respectively. Capital
expenditures for the prior year included $3.7 million for improvement of
the Company’s capabilities at its manufacturing plant in Norwood, MA and
$10.8 million under a tenant allowance to build out the laboratory and
office space at the Waltham, MA facility.
Financial Guidance
ImmunoGen expects its net loss for its fiscal year ending June 30, 2010
to be between $44-47 million, its cash used in operations to be between
$32-35 million and its capital expenditures to be between $1-2 million.
Cash and marketable securities at June 30, 2010 are anticipated to be
between $38-40 million.
“As we look out over the next few years, we expect our cash use to peak
in our 2010 fiscal year,” commented Gregory Perry, Senior Vice President
and Chief Financial Officer. “This is because, while overall fiscal 2010
expenses are expected to be comparable to those in fiscal 2009, we
currently do not expect fiscal 2010 milestones and research support
funding to reach last year’s levels. We expect greater milestone
payments and potentially growing royalty revenue to benefit our
financial results beginning in fiscal 2011. Additionally, we believe we
have a range of business development opportunities that can create value
and provide non-dilutive sources of cash that potentially would enhance
our cash generation in fiscal 2010 and beyond.”
UPDATE ON THE CLINICAL-STAGE ANTICANCER COMPOUNDS
Trastuzumab-DM1 (T-DM1)
T-DM1 consists of ImmunoGen’s DM1 cancer-cell killing agent linked to
the HER2-binding antibody, trastuzumab, and is in development by
Genentech and Roche.
-
Encouraging T-DM1 (non-pivotal) clinical data were reported at the
ASCO annual meeting in May 2009.
-
Roche projected in July 2009 that clinical data from the Phase II
trial evaluating T-DM1 as a third-line treatment1 for
HER2-positive metastatic breast cancer (HER2+ MBC) will be available
in the fourth quarter of 2009. Roche also noted the potential
submission of a regulatory filing in 2010 for marketing approval of
T-DM1 for this use.
-
T-DM1, given as a single agent, also is being evaluated as a
second-line treatment2 for HER2+ MBC in a Phase III trial
and as a first-line treatment for this cancer in a Phase II trial.
-
Patient enrollment is underway in early-stage clinical trials
evaluating T-DM1 used in combination with docetaxel (Taxotere®) and
used in combination with pertuzumab. A trial assessing T-DM1 used in
combination with GDC-0941 is planned.
IMGN901
This ImmunoGen TAP compound is in development for the treatment of CD56+
cancers.
-
Encouraging clinical findings with IMGN901 for CD56+ solid tumors were
presented at the 13th World Conference on Lung Cancer.
-
Updated clinical data with IMGN901 for CD56+ multiple myeloma (MM) are
expected to be reported in the fourth quarter of 2009. These are
expected to include new findings related to the durability of
responses to treatment with IMGN901 among patients whose MM has
progressed on multiple prior therapies.
-
The maximum tolerated dose (MTD) has been established with IMGN901
when used alone to treat MM. IMGN901 can now be dosed at its MTD in an
expanded number of patients with recurrent MM.
-
ImmunoGen intends to initiate a Phase I clinical trial evaluating
IMGN901 used in combination with lenalidomide (Revlimid®) plus
dexamethasone in September/ October 2009.
SAR3419
SAR3419 consists of ImmunoGen’s DM4 cancer-cell killing agent linked to
a CD19-binding antibody that was developed and humanized by ImmunoGen.
SAR3419 is being developed for the treatment of non-Hodgkin’s lymphoma
by sanofi-aventis.
-
The first SAR3419 clinical findings are expected to be reported in the
fourth quarter of 2009.
IMGN388, BT-062 and BIIB015
These are the most recent TAP compounds to enter clinical testing.
IMGN388 is in development by ImmunoGen, while BT-062 and BIIB015 are in
development by Biotest and Biogen Idec, respectively.
-
The first BT-062 clinical findings are expected to be reported in the
fourth quarter of 2009.
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
product pipeline, compounds utilizing the TAP technology are in clinical
testing through ImmunoGen’s collaborations with Genentech (a
wholly-owned member of the Roche Group), sanofi-aventis, Biogen Idec and
Biotest. The most advanced compound, T-DM1, is in Phase III testing
being conducted by Genentech and Roche. Other ImmunoGen collaborative
partners include Bayer HealthCare and Amgen.
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 2010 fiscal
year; its cash and marketable securities as of June 30, 2010; the
advancement of trastuzumab-DM1 (T-DM1); the Company’s and its
collaboration partners’ clinical trial activity and presentation of
clinical data; and the Company’s partnering activities. 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 as well as the research processes of
potential collaboration partners; 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; 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, 2008 and other reports filed with the Securities and Exchange
Commission.
Taxotere® is a registered trademark of sanofi-aventis.
Revlimid® is
a registered trademark of Celgene Corporation.
1 Patients must have had prior treatment with at least two
lines of anti-HER2 therapy in the metastatic setting, and must have
received an anthracycline, a taxane, trastuzumab, lapatinib and
capecitabine in the neoadjuvant, adjuvant, locally advanced or
metastatic setting.
2 Patients must have received prior treatment that included
both a taxane (alone or in combination with another agent) and
trastuzumab in the adjuvant, locally advanced or metastatic setting.
|
IMMUNOGEN, INC.
|
|
SELECTED FINANCIAL INFORMATION
|
|
(in thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
2008
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities
|
|
$
|
71,125
|
|
$
|
47,871
|
|
|
|
|
|
|
|
|
Other assets
|
|
|
29,579
|
|
|
35,467
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
100,704
|
|
$
|
83,338
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
$
|
11,128
|
|
$
|
10,386
|
|
|
|
|
|
|
|
|
Long-term portion of deferred revenue and other long-term liabilities
|
|
|
22,719
|
|
|
17,653
|
|
|
|
|
|
|
|
|
Shareholders' equity
|
|
|
66,857
|
|
|
55,299
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders' equity
|
|
$
|
100,704
|
|
$
|
83,338
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
(Unaudited)
|
|
|
|
|
|
Three Months Ended
|
|
Year Ended
|
|
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and milestone fees
|
|
$
|
814
|
|
$
|
1,060
|
|
$
|
15,117
|
|
$
|
13,156
|
|
|
Clinical materials reimbursement
|
|
|
2,320
|
|
|
49
|
|
|
5,305
|
|
|
12,058
|
|
|
Research and development support
|
|
|
1,168
|
|
|
3,374
|
|
|
7,566
|
|
|
15,035
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
4,302
|
|
|
4,483
|
|
|
27,988
|
|
|
40,249
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
11,663
|
|
|
12,739
|
|
|
45,904
|
|
|
60,013
|
|
|
General and administrative
|
|
|
3,458
|
|
|
3,722
|
|
|
13,900
|
|
|
14,348
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
15,121
|
|
|
16,461
|
|
|
59,804
|
|
|
74,361
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(10,819)
|
|
|
(11,978)
|
|
|
(31,816)
|
|
|
(34,112)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (expense)/income, net
|
|
|
(8)
|
|
|
55
|
|
|
(221)
|
|
|
2,119
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxes
|
|
|
(10,827)
|
|
|
(11,923)
|
|
|
(32,037)
|
|
|
(31,993)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision/(benefit) for income taxes
|
|
|
-
|
|
|
5
|
|
|
(100)
|
|
|
27
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
$
|
(10,827)
|
|
$
|
(11,928)
|
|
$
|
(31,937)
|
|
$
|
(32,020)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted
|
|
$
|
(0.21)
|
|
$
|
(0.27)
|
|
$
|
(0.63)
|
|
$
|
(0.75)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average common shares outstanding, basic and diluted
|
|
|
51,635
|
|
|
43,863
|
|
|
51,068
|
|
|
42,969
|
ImmunoGen, Inc.
Carol Hausner, 781-895-0600
Executive
Director, Investor Relations and Corporate Communications
info@immunogen.com