UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d)
OF
THE SECURITIES EXCHANGE ACT OF 1934
Date
of
Report (Date of earliest event reported): February 2, 2006
ImmunoGen,
Inc.
(Exact
name of registrant as specified in its charter)
|
Massachusetts
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0-17999
|
04-2726691
|
||
|
(State
or other jurisdiction of incorporation)
|
(Commission
File Number)
|
(IRS
Employer Identification No.)
|
128
Sidney Street, Cambridge, MA 02139
(Address
of principal executive offices) (Zip Code)
Registrant's
telephone number, including area code: (617) 995-2500
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see
General
Instruction A.2. below):
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
ITEM
2.02 - RESULTS OF OPERATION AND FINANCIAL CONDITION
On
February 2, 2006, ImmunoGen, Inc. (Nasdaq: IMGN) issued a press release to
announce the company’s financial results for the quarter ended December 31,
2005. A copy of the press release is attached to this current report on Form
8-K
as Exhibit 99.1.
ITEM
9.01. FINANCIAL STATEMENTS AND EXHIBITS
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Exhibit
No.
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Exhibit
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|
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99.1
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Press
Release of ImmunoGen, Inc. dated February 2,
2006
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2
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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ImmunoGen,
Inc.
|
|
|
(Registrant)
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|
|
Date:
February 2, 2006
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/s/
Karleen M. Oberton
|
|
Karleen
M. Oberton
|
|
|
Senior
Corporate Controller
|
|
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(Principal
Accounting Officer)
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3
Exhibit
99.1
128
Sidney Street, Cambridge, MA 02139-4239 <
font id="TAB2" style="LETTER-SPACING: 9pt"> TEL:
(617)
995-2500 FAX: (617)
995-2510
Contacts:
|
Investors
Carol
Hausner
Executive
Director, Investor Relations and
Corporate
Communications
Tel:
(617) 995-2500
info@immunogen.com
|
Media
Tony
Loke
Rx
Communications Group, LLC
Tel:
(917) 322-2164
tloke@rxir.com
|
For
Immediate Release
ImmunoGen,
Inc. Reports Second Quarter Fiscal Year 2006 Financial
Results
-
Company
Provides Business Update -
CAMBRIDGE,
MA, February 2, 2006
-
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- and six-month
periods ended December 31, 2005 - the second quarter and first half,
respectively, of the Company’s 2006 fiscal year.
For
the
three-month period ended December 31, 2005, the Company reported a net
loss of
$3.5 million, or $0.09 per basic and diluted share, compared to a net loss
of
$2.2 million, or $0.05 per basic and diluted share, for the same period
last
year. The net loss for the three-month period ended December 31, 2005 includes
$0.6 million of stock compensation expense, equal to approximately $0.02
per
share, from the Company’s adoption of SFAS 123(R), Share-Based Payments, on July
1, 2005. SFAS 123(R) requires the Company to record stock compensation
expense
based on the fair value of options granted to employees. For the six-month
period ended December 31, 2005, the Company reported a net loss of $8.2
million,
or $0.20 per basic and diluted share, compared to a net loss of
$4.7 million, or $0.11 per basic and diluted share, for the same period
last year. The net loss for the six-month period ended December 31, 2005
includes $1.2 million of stock compensation expense, equal to approximately
$0.03 per share, due to the Company’s adoption of SFAS 123(R), Share-Based
Payments, on July 1, 2005.
Revenues
for the three-month period ended December 31, 2005 were $6.6 million, compared
to $9.0 million for the same period last year. The second quarter 2006
revenues
include $5.2 million of research and development support fees, compared
to $4.4
million for the same period last year, and $1.3 million of license and
milestone
fees, compared to $1.0 million for the same period last year. Research
and
development support fees primarily represent funding earned pursuant to
the
Company’s discovery, research, and commercialization collaboration with the
sanofi-aventis Group and, to a lesser extent, funding earned under the
Company’s
development and license agreements with certain of its other collaborative
partners. The second quarter 2006 revenues include $0.1 million of clinical
material reimbursement, compared to $3.6 million for the same period last
year.
ImmunoGen
manufactures clinical materials on behalf of its collaborators and earns
clinical material reimbursement revenue with the supply of these materials
to
the collaborators. The clinical material reimbursement revenue for the
three-month period ended December 31, 2005 reflects that the Company did
not
provide batches to its collaborators at the level of the prior year for
reasons
related to the amount of materials needed to support collaborator
programs.
Revenues
for the six-month period ended December 31, 2005 were $14.4 million, compared
to
$18.1 million for the same period last year. The first half fiscal 2006
revenues
include $10.9 million of research and development support fees as compared
to
$9.0 million for the same period last year. Of the $10.9 million,
$1.1 million represents funding related to research and development
performed during the Company’s 2005 fiscal year under the sanofi-aventis Group
collaboration, but recognized in fiscal 2006. Also included in the first
half
fiscal 2006 revenues were $2.5 million of license and milestone fees and
$0.9
million of clinical materials reimbursement, compared to $2.6 million and
$6.5 million, respectively, for the same period last year. The research and
development support fees primarily represent funding earned pursuant to
the
Company’s collaboration with the sanofi-aventis Group and, to a lesser extent,
funding earned under the Company’s development and license agreements with
certain of its other collaborative partners. The clinical material reimbursement
revenue for the six-month period ended December 31, 2005 reflects that
the
Company did not provide batches to its collaborators at the level of the
prior
year for reasons related to the amount of materials needed to support
collaborator programs.
Operating
expenses for the three-month period ended December 31, 2005 were
$11.2 million, compared to $11.7 million for the same period last year. The
second quarter 2006 operating expenses include research and development
expenses
of $8.8 million, compared to $6.4 million for the same period last year.
This
increase is primarily the result of higher compensation costs due to an
increase
in personnel supporting the advancement of ImmunoGen’s and collaborators’
product candidates and to the effects of the adoption of SFAS 123(R). Also
contributing to the increase was an incremental $0.7 million related to
materials for use in the Company’s clinical trials. The cost of clinical
material reimbursed was $0.1 million in the second quarter 2006 as compared
with
$3.0 million for the same period last year. The second quarter 2006
operating expenses also include general and administrative expenses of
$2.3
million - comparable to the same period last year.
Operating
expenses for the six-month period ended December 31, 2005 were
$24.4 million, compared to $23.5 million for the same period last year. The
first half fiscal 2006 operating expenses include research and development
expenses of $18.3 million, compared to $14.0 million for the same period
last
year. The increase in research and development expenses is primarily the
result
of higher compensation costs due to an increase in personnel supporting
the
advancement of product candidates and to the effects of the adoption of
SFAS
123(R). Also contributing to the increase was the effect of less manufacturing
overhead being charged to collaborators due to reduced clinical material
being
produced for our collaborators. The cost of clinical material reimbursed
was
$1.0 million in the first half fiscal 2006 as compared with $5.5 million
for the same period last year. The first half 2006 operating expenses also
include general and administrative expenses of $5.1 million as compared
to $3.9
million for the same period last year. The
2
increase
in general and administrative expenses is primarily the result of higher
compensation costs due to the adoption of SFAS 123 (R) and more personnel
and to increased patent expenses.
Other
income, primarily consisting of interest income, was $1.1 million in the
three-month period ended December 31, 2005, compared to $0.4 million for
the
same period last year, and was $1.8 million in the six-month period ended
December 31, 2005, compared to $0.8 million for the same period last year.
The increased interest income in both the second quarter and first half
fiscal
2006 was attributable to higher rates of return on investments compared
with the
same periods last year. During the three-month period ended December 31,
2005, the Company also recorded as other income $365,000 associated with
the
assumption of a clinical trial from a former partner.
ImmunoGen
had approximately $85.0 million in cash and marketable securities as of
December
31, 2005, compared with $90.6 million as of June 30, 2005, with no outstanding
debt in either period. During the first half of fiscal 2006, cash used
in
operations was $4.6 million, compared to $43,000 during the same period
last year. Cash used in operations is primarily to fund the net loss, and
the
greater use of funds in the first half fiscal 2006 was principally due
to the
increased net loss compared to the same period last year without benefit
of the
reduction in working capital that occurred during the same period last
year.
Mitchel
Sayare, Chairman and CEO commented, “In the past three months, we reported
encouraging initial data from a Phase I trial evaluating our huN901-DM1
compound
in CD56-expressing solid tumors, took over responsibility for this study
from a
former partner, and significantly increased the number of clinical centers
participating in our two other huN901-DM1 trials. At the same time, we
made
significant progress in the Phase I trial underway with our huC242-DM4
product
candidate and are very pleased with the rate of patient enrollment in this
study. During this same period, Genentech filed an Investigational New
Drug, or
IND, application for its TAP compound, trastuzumab-DM1, and ImmunoGen earned
a
$2 million milestone payment when this IND recently became effective.”
ImmunoGen’s
TAP technology uses tumor-targeting antibodies to deliver a potent cell-killing
agent specifically to cancer cells. The Company develops its own products
using
its TAP technology and selectively outlicenses its technology to other
companies
for use with their proprietary antibodies.
Company
Update
ImmunoGen
is aggressively developing its wholly-owned compounds, and has four clinical
trials underway with its TAP compounds huN901-DM1 and huC242-DM4.
HuN901-DM1
HuN901-DM1
targets the CD56 antigen found on small-cell lung cancers (SCLC), other
cancers
of neuroendocrine origin, and certain hematological malignancies including
many
3
cases
of
multiple myeloma. ImmunoGen now is conducting three clinical trials with
huN901-DM1.
Phase
I
Trial
in
CD56-Expressing
Solid Tumors-
This
trial evaluates huN901-DM1 when administered daily for three consecutive
days in
a 21-day cycle to patients with CD56-expressing solid tumors, such as SCLC.
ImmunoGen reported initial data from this study at the AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer Therapeutics in
November 2005. Key findings include:
| · |
Dose
levels ranging from 4 to 36 mg/m2/day
(12 to 108 mg/m2
over three days) have been evaluated without establishment of
the maximum
tolerated dose. Evaluation of 48 mg/m2/day
was underway at the time of the
Conference.
|
| · |
A
sustained complete remission was reported in one of the three
patients
treated at the 36 mg/m2/day
dose level. This patient had been diagnosed with Merkel cell
cancer in
late 2003, undergone surgery, radiation therapy, and chemotherapy,
and had
a reappearance of her cancer by late 2004. After commencing treatment
with
huN901-DM1, she had been in remission for 15 weeks at the time
of the
Conference.
|
| · |
Five
other patients had stable disease lasting 6 to 18 weeks. Response
information was available for twenty-one patients at the time
of the
Conference, inclusive of patients receiving the lowest dose levels
evaluated.
|
In
December 2005, ImmunoGen gained control of this study from former partner
Vernalis plc., and patient enrollment is ongoing at clinical centers in
both the United States and United Kingdom.
Phase
I/II Trial in SCLC-
Patients are being enrolled in the Phase II leg of this study, which evaluates
huN901-DM1 in patients with relapsed or refractory SCLC. In this study,
the
compound is administered weekly for four weeks in a six-week cycle. ImmunoGen
took control of this study from Vernalis in July 2004 and reported initial
Phase
II findings at the annual meeting of the American Society of Clinical Oncology
(ASCO) in May 2005. Objective evidence of anticancer activity was reported
among
the initial patients treated, triggering expansion of this study to include
more
patients. Over the past six months, ImmunoGen has substantially increased
the
number of clinical centers participating in this study, resulting in a
significant increase in the rate of patient enrollment.
Phase
I Trial in Multiple Myeloma-
In
September 2005, ImmunoGen initiated a Phase I trial evaluating huN901-DM1
in the
treatment of multiple myeloma. In the past three months, ImmunoGen has
expanded
the number of clinical centers participating in this study.
While
huN901-DM1 is given as a single agent in all of the studies now underway,
SCLC
is commonly treated with a combination of agents. At the AACR-NCI-EORTC
conference in November, ImmunoGen scientists reported preclinical data
that
showed that use of huN901-DM1 in combination with current treatments for
SCLC
markedly enhanced the activity of these agents against human SCLC tumors
without
a significant increase in toxicity.
4
HuC242-DM4
HuC242-DM4
targets the CanAg antigen found on colorectal, pancreatic, and other
gastrointestinal cancers as well as on many non-small-cell lung cancers.
HuC242-DM4 is currently being evaluated in patients with refractory,
CanAg-expressing cancers in a dose-escalation Phase I study. Patient enrollment
is proceeding well.
Data
from
preclinical huC242-DM4 pharmacokinetic and biodistribution studies were
reported
at the AACR-NCI-EORTC conference in November. The studies provide further
support that the compound’s antibody-drug linkage is stable while huC242-DM4 is
circulating in the bloodstream, that the compound successfully accumulates
at
the tumor site, and that the level of huC242-DM4 in the tumor remains higher
than its level in the blood for an extended period of time.
Additional
preclinical data on huC242-DM4 has been accepted for presentation at the
annual
meeting of the American Association for Cancer Research (AACR), which will
be
held April 1 - 5, 2006 in Washington, DC.
Update
on ImmunoGen Collaborations
On
January 31, 2006, ImmunoGen announced that the Company had
been
informed by Genentech that the trastuzumab-DM1 IND application submitted
by
Genentech to the US FDA has become effective. This event triggers a
$2 million milestone payment to ImmunoGen. Trastuzumab-DM1 comprises
ImmunoGen’s DM1 linked to Genentech’s therapeutic antibody, trastuzumab.
Trastuzumab targets overexpression of the HER2 protein, which is associated
with
approximately 20 percent of all breast cancers.
Trastuzumab-DM1
is the first TAP compound that uses ImmunoGen's TAP technology in conjunction
with a therapeutic antibody that has demonstrated significant anticancer
activity when administered as a naked antibody. The compound was developed
under
a 2000 agreement that gave Genentech an exclusive license to use ImmunoGen’s
maytansinoid TAP technology with therapeutic antibodies to HER2, including
trastuzumab. This agreement entitles ImmunoGen to receive milestone payments
upon achievement of the events defined in that agreement, and also to receive
royalties on the sales of any products that use ImmunoGen’s maytansinoid TAP
technology. Genentech is responsible for product development, manufacturing,
and
commercialization.
In
December 2005, Genentech licensed the exclusive right to use ImmunoGen’s
maytansinoid TAP technology with therapeutic antibodies to an undisclosed
target. ImmunoGen received a $1 million upfront license payment and, under
the
terms of the license, is entitled to receive milestone payments and also
royalties on the sales of any resulting products. Genentech is responsible
for
the development, manufacturing, and commercialization of any products resulting
from the license. This is the third such license to be taken by Genentech
under
a collaborative agreement executed in 2000 and renewed by Genentech in
2005 that
grants Genentech certain rights to test ImmunoGen’s maytansinoid TAP technology
with therapeutic antibodies and to license rights to use the technology
to
develop products. Earlier in 2005, Genentech licensed the rights to use
ImmunoGen’s maytansinoid TAP technology with antibodies to two other undisclosed
targets under this agreement.
5
On
January 26, 2006, Millennium Pharmaceuticals, Inc. disclosed that it was
discontinuing development of its TAP compound, MLN2704.
Webcast
Information
A
live
conference call and webcast are scheduled for today, February 2, 2006 at
4:30 p.m. ET. This call will include management discussion of
financial results and provide an update on ImmunoGen.
To
access
the live conference call by phone, dial 913-981-4900. No passcode is required.
A
playback of the call will be available from approximately 7:30 p.m. on
February
2, 2006 through 11:59 p.m. on February 8, 2006. To listen to the playback,
call
719-457-0820 and provide passcode 5230482. The call also may be heard through
the Investor Relations section on ImmunoGen’s website, www.immunogen.com.
Following the live webcast, a replay of the call will be available at the
same
location through February 8, 2006.
About
ImmunoGen, Inc.
ImmunoGen,
Inc. develops targeted anticancer biopharmaceuticals. The Company’s proprietary
TAP technology uses tumor-targeting antibodies to deliver a potent, cell-killing
agent specifically to cancer cells. Three TAP compounds are in clinical
testing
- huN901-DM1 and huC242-DM4, which are wholly owned by ImmunoGen, and AVE9633,
which is in development by the sanofi-aventis Group. A fourth TAP compound,
trastuzumab-DM1 in development by Genentech, now has an effective IND.
Genentech, Centocor (a wholly-owned subsidiary of Johnson & Johnson), Biogen
Idec, the sanofi-aventis Group, Millennium Pharmaceuticals, Inc., Boehringer
Ingelheim, and Abgenix have licensed the right to develop and/or test TAP
compounds to specific targets; ImmunoGen also has a broader collaboration
with
the sanofi-aventis Group.
This
press release includes forward-looking statements based on management’s current
expectations. 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 the Company’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 the Company’s
research and clinical development processes; the outcome of 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 and clinical trials; the Company’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, 2005 and
other
reports filed with the Securities and Exchange Commission.
-financials
follow-
6
IMMUNOGEN,
INC.
SELECTED
FINANCIAL INFORMATION
(in
thousands, except per share amounts)
CONDENSED
CONSOLIDATED BALANCE SHEETS
As
of December 31, 2005 and June 30, 2005
(Unaudited)
|
December
31,
|
June
30,
|
||||
|
2005
|
2005
|
||||
|
ASSETS
|
|||||
|
Cash
and marketable securities
|
$
|
85,000
|
$
|
90,565
|
|
|
Other
assets
|
19,454
|
19,567
|
|||
|
Total
assets
|
$
|
104,454
|
$
|
110,132
|
|
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||
|
Current
liabilities
|
$
|
10,966
|
$
|
9,226
|
|
|
Long-term
portion of deferred revenue and other long-term
liabilities
|
13,353
|
14,064
|
|||
|
Stockholders’
equity
|
80,135
|
86,842
|
|||
|
Total
liabilities and stockholders’ equity
|
$
|
104,454
|
$
|
110,132
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
For
the three and six months ended December 31, 2005 and 2004
(Unaudited)
|
Three
Months Ended December 31,
|
Six
Months Ended December 31,
|
||||||||||||
|
2005
|
2004
|
2005
|
2004
|
||||||||||
|
Revenues:
|
|||||||||||||
|
Research
and development support
|
$
|
5,231
|
$
|
4,376
|
$
|
10,917
|
$
|
8,975
|
|||||
|
License
and milestone fees
|
1,275
|
1,034
|
2,536
|
2,576
|
|||||||||
|
Clinical
materials reimbursement
|
81
|
3,637
|
912
|
6,503
|
|||||||||
|
Total
revenues
|
6,587
|
9,047
|
14,365
|
18,054
|
|||||||||
|
Expenses:
|
|||||||||||||
|
Cost
of clinical materials reimbursed
|
94
|
3,042
|
999
|
5,536
|
|||||||||
|
Research
and development (1)
|
8,760
|
6,358
|
18,252
|
13,989
|
|||||||||
|
General
and administrative (1)
|
2,332
|
2,256
|
5,125
|
3,937
|
|||||||||
|
Total
operating expenses
|
11,186
|
11,656
|
24,376
|
23,462
|
|||||||||
|
Loss
from operations
|
(4,599)
|
|
(2,609)
|
|
(10,011)
|
|
(5,408)
|
||||||
|
Other
income, net
|
1,103
|
420
|
1,819
|
751
|
|||||||||
|
Income
(loss) before taxes
|
(3,496)
|
|
(2,189)
|
|
(8,192)
|
|
(4,657)
|
||||||
|
Income
tax expense
|
6
|
20
|
16
|
23
|
|||||||||
|
Net
income (loss)
|
$
|
(3,502)
|
|
$
|
(2,209)
|
|
$
|
(8,208)
|
|
$
|
(4,680)
|
||
|
Basic
and diluted net loss per common share
|
$
|
(0.09)
|
|
$
|
(0.05)
|
|
$
|
(0.20)
|
|
$
|
(0.11)
|
||
|
Basic
and diluted weighted average common shares
outstanding
|
41,079
|
40,800
|
41,072
|
40,795
|
|||||||||
|
(1)
Stock compensation is included in the following categories during
the
three and six months ended December 31, 2005 and 2004:
|
|||||||||||||
|
2005
|
2004
|
2005
|
2004
|
||||||||||
|
Research
and development
|
$
|
350
|
$
|
-
|
$
|
702
|
$
|
-
|
|||||
|
General
and administrative
|
190
|
177
|
544
|
180
|
|||||||||
|
$
|
540
|
$
|
177
|
$
|
1,246
|
$
|
180
|
||||||
7