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): May 4, 2006
ImmunoGen,
Inc.
(Exact
name of registrant as specified in its charter)
|
Massachusetts
|
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
May 4,
2006, ImmunoGen, Inc. (Nasdaq: IMGN) issued a press release to announce the
company’s financial results for the quarter ended March 31, 2006. A copy of the
press release is attached to this current report on Form 8-K as Exhibit
99.1.
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
|
Exhibit
No.
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Exhibit
|
|
|
99.1
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Press
Release of ImmunoGen, Inc. dated May 4,
2006
|
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.
|
ImmunoGen,
Inc.
|
|
|
(Registrant)
|
|
|
Date:
May 4, 2006
|
/s/
Karleen M. Oberton
|
|
Karleen
M. Oberton
|
|
|
Senior
Corporate Controller
|
|
|
(Principal
Accounting Officer)
|
3
Exhibit
99.1
128
Sidney Street, Cambridge, MA 02139-4239 TEL:
(617) 995-2500FAX: (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 Third Quarter Fiscal Year 2006 Financial
Results
-
Company
Provides Business Update -
CAMBRIDGE,
MA, May 4, 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 nine-month
periods ended March 31, 2006 - the third quarter and first nine months of
the
Company’s 2006 fiscal year.
For
the
three-month period ended March 31, 2006, the Company reported a net loss
of
$3.0 million, or $0.07 per basic and diluted share, compared to a net loss
of $3.6 million, or $0.09 per basic and diluted share, for the same period
last
year. The net loss for the three-month period ended March 31, 2006 includes
$0.6
million of stock compensation expense, equal to approximately $0.01 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 nine-month
period ended March 31, 2006, the Company reported a net loss of $11.2 million,
or $0.27 per basic and diluted share, compared to a net loss of
$8.2 million, or $0.20 per basic and diluted share, for the same period
last year. The net loss for the nine-month period ended March 31, 2006 includes
$1.8 million of stock compensation expense, equal to approximately $0.04
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 March 31, 2006 were $9.4 million, compared
to
$10.2 million for the same period last year. The third quarter 2006 revenues
include $5.3 million of research and development support fees, compared to
$4.8 million for the same period last year, and $3.3 million of license and
milestone fees, compared to $3.0 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 third quarter 2006 revenues also include
$0.8 million
-more-
of
clinical material reimbursement, compared to $2.4 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 lower clinical material
reimbursement revenue for the three-month period ended March 31, 2006 versus
the
comparable prior year period reflects a reduction in the materials needed
to
support collaborator programs, particularly the Boehringer Ingelheim and
Millennium Pharmaceuticals, Inc. programs.
Revenues
for the nine-month period ended March 31, 2006 were $23.7 million, compared
to
$28.3 million for the same period last year. The nine-month fiscal 2006 revenues
include $16.2 million of research and development support fees as compared
to
$13.8 million for the same period last year. Of the $16.2 million,
$1.1 million represents funding related to research and development efforts
performed during the Company’s 2005 fiscal year under the sanofi-aventis Group
collaboration, but recognized in fiscal 2006. Also included in the nine-month
period revenues were $5.8 million of license and milestone fees and $1.7
million
of clinical materials reimbursement, compared to $5.6 million and
$8.9 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 lower clinical materials
reimbursement revenue for the nine-month period ended March 31, 2006 versus
the
comparable prior year period reflects a reduction in the materials needed
to
support collaborator programs, particularly the Boehringer Ingelheim and
Millennium Pharmaceuticals, Inc. programs.
Operating
expenses for the three-month period ended March 31, 2006 were
$13.2 million, compared to $14.2 million for the same period last year. The
third quarter 2006 operating expenses include research and development expenses
of $10.2 million, compared to $9.7 million for the same period last year.
This increase is primarily the result of an incremental $1.1 million related
to
the manufacture of and process development efforts related to materials for
use
in the Company’s clinical trials as well as an incremental $0.3 million in
clinical trial expense. Also contributing to the increase were 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). Partially offsetting these increases were lower
expenses to reserve for excess quantities of ansamitocin P3 and DM1/DM4 in
accordance with our inventory reserve policy.
The cost
of clinical material reimbursed was $0.8 million in the third quarter 2006
as
compared with $2.3 million for the same period last year. The third quarter
2006 operating expenses also include general and administrative expenses
of $2.2
million as compared to $2.3 million for the same period last year.
Operating
expenses for the nine-month period ended March 31, 2006 were $37.6 million,
compared to $37.7 million for the same period last year. The nine-month
operating expenses include research and development expenses of $28.5 million,
compared to $23.7 million for the same period last year. This increase is
primarily the result of an incremental $2.4 million related to the manufacture
of and process development efforts related to materials for use in the Company’s
clinical trials as well as an incremental $0.7 million in clinical trial
expense. Also contributing to the increase were 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). Partially offsetting these
-more-
increases
were lower
expenses to reserve for excess quantities of ansamitocin P3 and DM1/DM4 in
accordance with our inventory reserve policy. The
cost
of clinical material reimbursed was $1.8 million in the nine-months ended
March 31, 2006 as compared with $7.8 million for the same period last year.
The
nine-month operating expenses also include general and administrative expenses
of $7.3 million as compared to $6.2 million for the same period last year.
The
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 $0.9 million in the
three-month period ended March 31, 2006, compared to $0.5 million for the
same
period last year, and was $2.7 million in the nine-month period ended March
31,
2006, compared to $1.2 million for the same period last year. The increased
interest income in both the third quarter and first nine months of fiscal
2006
was attributable to higher rates of return on investments compared with the
same
periods last year.
ImmunoGen
had approximately $82.8 million in cash and marketable securities as of March
31, 2006, compared with $90.6 million as of June 30, 2005, with no outstanding
debt in either period. During the first nine months of fiscal 2006 cash used
in
operations was $7.1 million, compared to $1.5 million 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 nine months of fiscal 2006 compared
to the
same period last year was principally due to the increased net loss without
benefit of the reduction in working capital that occurred during the same
period
last year.
“Data
reported at the recent AACR annual meeting reflect our ability to tailor
the
design of each TAP compound to achieve the broadest therapeutic window -
the
greatest efficacy with the least toxicity - for each antibody and target,”
commented Mitchel Sayare, Chairman and CEO. “These innovations are reflected in
TAP compounds already in clinical testing as well as those advancing towards
the
clinic. Based on the progress we are making with our clinical programs and
the
progress being made by our collaborators, we expect that the body of clinical
data on TAP compounds will start to ramp up significantly beginning this
fall.”
Company
Update
TAP
Technology
In
the
past few years, ImmunoGen has greatly expanded its ability to customize the
design of each TAP compound to maximize the therapeutic window - advancements
reflected in compounds now in clinical testing. In April 2006, ImmunoGen
reported results at the American Association for Cancer Research (AACR) annual
meeting that demonstrate the significance of the Company’s design options.
Findings presented include data on how the design of a TAP compound impacts
its
activity against different types of tumors (e.g., tumors with homogenous
vs.
heterogeneous expression of the target antigen, tumors with different degrees
of
sensitivity to maytansinoid cell-killing agents) as well as its pharmacokinetics
and intracellular metabolism.
-more-
ImmunoGen’s
design innovations are reflected in the Company’s own compounds and in those in
development by ImmunoGen collaborators.
Compounds
already in clinical testing as well as those advancing towards the clinic
include different cell-killing agents and linkers (the means of attachment
of
the killing agent to the antibody) as a result of evaluation of alternative
design options and the selection of the best option for each antibody and
target.
Product
Candidates
HuN901-DM1
- In initial clinical testing, huN901-DM1 has demonstrated objective evidence
of
anticancer activity at doses that are well tolerated. HuN901-DM1 is wholly-owned
by ImmunoGen and targets the CD56 antigen found on small-cell lung cancers
(SCLC), other cancers of neuroendocrine origin,
and
certain hematological malignancies. Updates on the three clinical trials
underway with the compound include:
| · |
Phase
I Trial in CD56-Expressing Solid Tumors
-
When initial findings - including objective evidence of anticancer
activity - were reported at a research conference in November 2005,
the
highest dose level that had completed evaluation was
36 mg/m2/day
(108 mg/m2
over three days given every 21 days). Several higher dose levels
have been
evaluated since then without establishment of the maximum tolerated
dose,
and thus dose escalation is continuing.
|
| · |
Phase
I/II Trial in SCLC
-
ImmunoGen has greatly expanded the number of clinical centers
participating in the Phase II leg of this study, resulting in a marked
increase in the rate of patient enrollment. In this leg of the trial,
all
patients receive 60 mg/m2
of
huN901-DM1 weekly for four weeks every six weeks.
|
| · |
Phase
I Trial in CD56-Expressing Multiple Myeloma -
Several clinical centers are now enrolling patients in this trial,
and
dose escalation is ongoing.
|
HuC242-DM4
- This compound also is wholly-owned by ImmunoGen, and is in Phase I testing
for
the treatment of CanAg-expressing cancers, such as colorectal, pancreatic,
and
other gastrointestinal cancers. A number of dose levels have been evaluated
without establishment of the maximum tolerated dose, so increasingly higher
doses continue to be evaluated. Patient enrollment is proceeding well.
HuC242-DM4 is the successor to an earlier compound - cantuzumab mertansine
-
that demonstrated evidence of anticancer activity in initial clinical testing.
In preclinical evaluation, huC242-DM4 was found to be significantly more
active
than cantuzumab mertansine against CanAg-positive tumors with the same
tolerability.
AVE9633
-
This compound is in Phase I clinical testing in the US and now also in Europe
for the treatment of acute myeloid leukemia. The compound was initially
developed by ImmunoGen and was licensed to the sanofi-aventis Group as part
of a
broader collaboration between the companies. It targets the CD33 antigen
found
on acute myeloid leukemia cells.
Trastuzumab-DM1
- This compound is in development by Genentech. Phase I testing in patients
with
HER2-positive metastatic breast cancer began in April 2006.
-more-
Webcast
Information
A
live
conference call and webcast are scheduled for today, May 4, 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 May
4,
2006 through 11:59 p.m. on May 10, 2006. To listen to the playback, call
719-457-0820 and provide passcode 1727841. 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 May 10, 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. Four TAP compounds are in clinical testing
-
huN901-DM1 and huC242-DM4, which are wholly owned by ImmunoGen, and AVE9633
and
trastuzumab-DM1, which are in development by the sanofi-aventis Group and
Genentech, respectively. The sanofi-aventis Group, Genentech, Centocor, Biogen
Idec, Boehringer Ingelheim, Millennium Pharmaceuticals, Inc., and Amgen
(formerly 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-
-more-
IMMUNOGEN,
INC.
SELECTED
FINANCIAL INFORMATION
(in
thousands, except per share amounts)
CONDENSED
CONSOLIDATED BALANCE SHEETS
As
of March 31, 2006 and June 30, 2005
(Unaudited)
|
March
31,
|
June
30,
|
||||||
|
2006
|
2005
|
||||||
|
ASSETS
|
|||||||
|
Cash
and marketable securities
|
$
|
82,765
|
$
|
90,565
|
|||
|
Other
assets
|
19,977
|
19,567
|
|||||
|
Total
assets
|
$
|
102,742
|
$
|
110,132
|
|||
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
|
Current
liabilities
|
$
|
12,579
|
$
|
9,226
|
|||
|
Long-term
portion of deferred revenue and other long-term
liabilities
|
11,742
|
14,064
|
|||||
|
Stockholders’
equity
|
78,421
|
86,842
|
|||||
|
Total
liabilities and stockholders’ equity
|
$
|
102,742
|
$
|
110,132
|
|||
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
For
the three and nine months ended March 31, 2006 and 2005
(Unaudited)
|
Three
Months Ended
March
31,
|
Nine
Months Ended
March
31,
|
||||||||||||
|
2006
|
2005
|
2006
|
2005
|
||||||||||
|
Revenues:
|
|||||||||||||
|
Research
and development support
|
$
|
5,258
|
$
|
4,776
|
$
|
16,175
|
$
|
13,751
|
|||||
|
License
and milestone fees
|
3,275
|
3,040
|
5,811
|
5,615
|
|||||||||
|
Clinical
materials reimbursement
|
822
|
2,415
|
1,734
|
8,918
|
|||||||||
|
Total
revenues
|
9,355
|
10,231
|
23,720
|
28,284
|
|||||||||
|
Expenses:
|
|||||||||||||
|
Cost
of clinical materials reimbursed
|
779
|
2,286
|
1,778
|
7,822
|
|||||||||
|
Research
and development (1)
|
10,216
|
9,669
|
28,467
|
23,659
|
|||||||||
|
General
and administrative (1)
|
2,193
|
2,277
|
7,319
|
6,213
|
|||||||||
|
Total
operating expenses
|
13,188
|
14,232
|
37,564
|
37,694
|
|||||||||
|
Loss
from operations
|
(3,833
|
)
|
(4,001
|
)
|
(13,844
|
)
|
(9,410
|
)
|
|||||
|
Other
income, net
|
853
|
455
|
2,672
|
1,206
|
|||||||||
|
Income
(loss) before taxes
|
(2,980
|
)
|
(3,546
|
)
|
(11,172
|
)
|
(8,204
|
)
|
|||||
|
Income
tax expense
|
1
|
5
|
17
|
27
|
|||||||||
|
Net
income (loss)
|
$
|
(2,981
|
)
|
$
|
(3,551
|
)
|
$
|
(11,189
|
)
|
$
|
(8,231
|
)
|
|
|
Basic
and diluted net loss per common share
|
$
|
(0.07
|
)
|
$
|
(0.09
|
)
|
$
|
(0.27
|
)
|
$
|
(0.20
|
)
|
|
|
Basic
and diluted weighted average common shares
outstanding
|
41,188
|
40,871
|
41,109
|
40,820
|
|||||||||
|
(1)
Stock compensation is included in the following categories during
the
three and nine months ended March 31:
|
|||||||||||||
|
2006
|
2005
|
2006
|
2005
|
||||||||||
|
Research
and development
|
$
|
378
|
$
|
-
|
$
|
1,080
|
$
|
-
|
|||||
|
General
and administrative
|
215
|
(50)
|
759
|
130
|
|||||||||
|
$
|
593
|
$
|
(50
|
) |
$
|
1,839
|
$
|
130
|
|||||