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): August 10, 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
August 10, 2006, ImmunoGen, Inc. (Nasdaq: IMGN) issued a press release to
announce the company’s financial results for the quarter and fiscal year ended
June 30, 2006. 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.
|
Exhibit
|
|
|
99.1
|
Press
Release of
ImmunoGen, Inc. dated August 10,
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:
August 10,
2006
|
/s/
Daniel M.
Junius
|
|
Daniel
M.
Junius
|
|
|
Executive
Vice
President and Chief Financial Officer
|
|
3
Exhibit
99.1
128
Sidney Street, Cambridge, MA 02139-4239 TEL:
(617)
995-2500FAX: (617) 995-2510
Contacts:
|
Carol
Hausner
Executive
Director,
Investor Relations and
Corporate
Communications
Tel:
(617) 995-2500
info@immunogen.com
|
For
Immediate
Release
ImmunoGen,
Inc.
Reports Fourth Quarter and Fiscal Year 2006 Financial
Results
-
Company
Provides
Business Update -
CAMBRIDGE,
MA,
August 10, 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-month period and fiscal year ended June 30,
2006.
“We’ve
made considerable progress in the past three months - both in the advancement
of
our own compounds and in our collaborations,” commented Mitchel Sayare, Chairman
and CEO of ImmunoGen. “We expect to report clinical data for both our huN901-DM1
and huC242-DM4 product candidates later this year, and to expand their clinical
programs in 2007 as part of our commitment to advance these agents as
expeditiously as possible. Two other TAP compounds - AVE9633 and trastuzumab-DM1
- are in Phase I testing through our collaborators, and we expect initial
clinical data on AVE9633 also to be reported later this year. In July, we
added
the eighth firm - Biotest AG - to the roster of major companies that have
licensed access to our TAP technology, and we’re delighted that our agreement
with them includes opt-in rights on the development and commercialization
of any
resulting compounds for the US.”
For
the three-month period ended June 30, 2006, ImmunoGen reported a net loss
of
$6.6 million, or $0.16 per basic and diluted share, compared to a net loss
of $2.7 million, or $0.07 per basic and diluted share, for the same period
last
year. The net loss for the fourth quarter of the Company’s 2006 fiscal year
includes $0.6 million of stock compensation expense, equal to approximately
$0.01 per share, due to 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 fiscal year ended June 30, 2006, ImmunoGen reported a net loss of
$17.8
million, or $0.43 per basic and diluted share, compared to a net loss of
$11.0 million, or $0.27 per basic and diluted share, for the fiscal year
ended June 30, 2005. The net loss for the 2006 fiscal year includes $2.4
million
of stock compensation expense, equal to approximately $0.06 per share, due
to
ImmunoGen’s adoption of SFAS 123(R), Share-Based Payments, on July 1, 2005.
Revenues
for the
three-month period ended June 30, 2006 were $8.4 million, compared to $7.4
million for the same period last year. The fourth quarter 2006 revenues include
$5.7 million of research and development support fees, compared to $4.7
million for the same period last year, and $1.3 million of license and milestone
fees, compared to $1.2 million for the same period last year. Research and
development support fees primarily represent funding earned pursuant to
ImmunoGen’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 other of its collaborative partners.
The
fourth quarter 2006 revenues include $1.4 million of clinical material
reimbursement, compared to $1.6 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.
Revenues
for the fiscal
year ended June 30, 2006 were $32.1 million, compared to $35.7 million for
the fiscal year ended June 30, 2005. Revenues for the 2006 fiscal year include
$21.8 million of research and development support fees as compared to
$18.4 million for the 2005 fiscal year. Of the $21.8 million, $1.1 million
represents funding under the collaboration with the sanofi-aventis Group
for
research and development activity performed in the Company’s 2005 fiscal year,
but recognized in fiscal year 2006. Also included in the fiscal year 2006
revenues are $7.2 million of license and milestone fees and $3.1 million
of
clinical materials reimbursement, compared to $6.8 million and $10.5
million, respectively, for fiscal year 2005. The lower clinical reimbursement
revenue for fiscal year 2006 compared with fiscal year 2005 is due to reduced
materials needed to support collaborator programs.
1
Operating
expenses for the
three-month period ended June 30, 2006 were $16.0 million, compared to $10.7
million for the same period last year. The fourth quarter 2006 operating
expenses include research and development expenses of $12.4 million, compared
to
$6.9 million for the same period last year. The increase was driven
primarily by an incremental $3.1 million for the manufacturing and process
development activity related to ImmunoGen compounds in clinical trials, as
well
as higher compensation costs due to an increase in personnel supporting the
advancement of ImmunoGen’s and its collaborators’ product candidates and to the
effects of the adoption of SFAS 123(R). The cost of clinical material reimbursed
was $0.9 million in the fourth quarter 2006 as compared to $1.4 million for
the same period last year. The fourth quarter 2006 operating expenses also
include general and administrative expenses of $2.6 million as compared to
$2.4
million for the same period last year.
Operating
expenses for the
fiscal year ended June 30, 2006 were $53.5 million, compared to $48.4 million
for the fiscal year ended June 30, 2005. Included in the operating expenses
for
2006 are research and development expense of $40.9 million, compared to
$30.5 million for the 2005 fiscal year. The increase was driven primarily
by an incremental $5.6 million for manufacturing and process development
efforts
related to ImmunoGen clinical compounds as well as to an incremental $0.6
million in clinical trial expense. The increase also was a result of higher
compensation costs due to an increase in personnel supporting the advancement
of
product candidates and 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 of DM1/DM4 in accordance with our inventory reserve
policy. The cost of clinical material reimbursed was $2.7 million in the
fiscal
year ended June 30, 2006, compared to $9.2 million for the fiscal year ended
June 30, 2005. Also included in the operating expenses for 2006 is general
and
administrative expense of $9.9 million, compared to $8.6 million for 2005.
The increase in general and administrative expenses was primarily the result
of
higher compensation costs due to the adoption of SFAS 123(R) and the hiring
of
additional personnel, and to increased patent expenses.
Other
income, primarily consisting of interest income, was $0.9 million in the
three-month period ended June 30, 2006, compared to $0.5 million for the
same
period last year, and was $3.6 million in the fiscal year ended June 30,
2006,
compared to $1.8 million for the fiscal year ended June 30, 2005. The increased
interest income was attributable to higher rates of return on investments
in
2006 compared to 2005.
ImmunoGen
had
approximately $75.0 million in cash and marketable securities as of June
30,
2006, compared with $90.6 million as of June 30, 2005, and had no outstanding
debt in either period. During the 2006 fiscal year, cash used in operations
was
$14.3 million, compared to $2.1 million during the 2005 fiscal year. Cash
used
in operations primarily funds the net loss, and the greater use of funds
in
fiscal 2006 compared to 2005 was principally due to the increased net loss
without the benefit of the reduction in working capital that occurred during
2005.
2
"We
ended fiscal year 2006 with $75 million in cash and securities, no debt,
and
non-dilutive funding generated from multiple collaborations," stated Daniel
Junius, Executive Vice President, Finance, and CFO of ImmunoGen. "We continue
to
apply financial discipline to our operations while aggressively developing
our
own compounds and preparing for their later-stage manufacturing. We ended
fiscal
year 2006 at the lower end of our guidance range for both net loss and cash
used
in operations. In fiscal year 2007 we expect cash used in operations to be
between $26 and $29 million, and our net loss to be between $26 and $29 million
- increases that reflect the anticipated advancement of our novel anticancer
compounds.”
Clinical
and
Business Update
ImmunoGen’s
HuN901-DM1 Product Candidate
This
TAP compound 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 including multiple myeloma. Updates
on ImmunoGen’s
three huN901-DM1 human clinical trials include:
| · |
Phase
I Trial in
SCLC and Other CD56-Expressing Solid Tumors (Study
002)
|
Initial
findings -
including objective evidence of anticancer activity - were reported at a
research conference in November 2005. At that time, the highest dose level
that
had completed evaluation was 36 mg/m2/day
(108 mg/m2
over three days given
every 21 days). Increasingly higher dose levels have been evaluated since
then
without establishment of the maximum tolerated dose, and thus dose escalation
is
continuing. ImmunoGen is targeting to report additional interim data from
this
study at a medical conference in November 2006.
| · |
Phase
I Trial in
CD56-Expressing Multiple Myeloma (Study
003)
|
Dose
escalation is ongoing in this study, which is underway at several clinical
sites. The Company is targeting to report initial findings from this study
at a
hematological medical meeting in December 2006.
| · |
Phase
II Trial in
SCLC (Study 001)
|
This
trial evaluates huN901-DM1 in patients with relapsed SCLC when dosed at
60 mg/m2
weekly for four weeks
every six weeks. In 2005, this study was expanded to include thirty-five
evaluable patients after objective evidence of anticancer activity - including
tumor shrinkage - was reported among the initial fourteen patients treated.
The
majority of the patients needed to complete this study already have been
enrolled.
ImmunoGen’s
HuC242-DM4 Product Candidate
This
product candidate is in Phase I testing for the treatment of CanAg-expressing
cancers, which include colorectal, pancreatic, other gastrointestinal cancers
and many non-small cell lung cancers. A number of dose levels have been
evaluated without establishment of the maximum tolerated dose, so increasingly
higher doses continue to be evaluated. The Company expects to report interim
findings from this study at a medical conference in November 2006.
Collaborations
In
July, Biotest AG licensed the exclusive rights to use ImmunoGen’s maytansinoid
TAP technology with antibodies to a specific target to create anticancer
therapeutics. Under the agreement with Biotest, ImmunoGen receives a $1.0
million upfront payment, potentially up to $35.5 million in milestone payments,
and royalties on the sales of any resulting products. ImmunoGen receives
manufacturing payments for any preclinical and clinical materials made at
the
request of Biotest. The agreement also provides the Company with the right
to
elect to participate in the US development and commercialization of any compound
created under this agreement in lieu of receiving royalties on the compound’s US
sales and milestone payments not yet earned. If ImmunoGen elects to exercise
this right, the two companies would share equally the associated costs of
product development and commercialization in the US along with the profit,
if
any, from US product sales.
Two
TAP compounds are in clinical testing through other ImmunoGen collaborations.
AVE9633, in development by the sanofi-aventis Group, is in clinical testing
in
the US and Europe for the treatment of acute myeloid leukemia. The Company
expects initial clinical findings with this compound to be reported at a
hematological medical meeting in December 2006. Trastuzumab-DM1, in development
by Genentech, is in clinical testing for the treatment of HER2-positive
metastatic breast cancer.
3
Webcast
Information
A
live
conference call and webcast are scheduled for today, August 10, 2006 at
4:30 p.m. EDT. This call will include an update on ImmunoGen,
management discussion of financial results and guidance for the Company’s 2007
fiscal year.
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 7:30 p.m. on August
10,
2006 through 11:59 p.m. on August 16, 2006. To listen to the playback, please
call 719-457-0820 and provide passcode 8945461. 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
August 16, 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. Amgen (formerly Abgenix), Biogen Idec, Biotest AG,
Boehringer Ingelheim, Centocor, Genentech, Millennium Pharmaceuticals, Inc.,
and
the sanofi-aventis Group 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-
4
SELECTED FINANCIAL INFORMATION
(in
thousands, except per share amounts)
CONDENSED
CONSOLIDATED BALANCE SHEETS
As
of June
30, 2006 and June 30, 2005
|
June
30,
|
June
30,
|
|||||
|
2006
|
2005
|
|||||
|
ASSETS
|
||||||
|
Cash
and
marketable securities
|
$
|
75,023
|
$
|
90,565
|
||
|
Other
assets
|
19,105
|
19,567
|
||||
|
Total
assets
|
$
|
94,128
|
$
|
110,132
|
||
|
LIABILITIES
AND
STOCKHOLDERS’ EQUITY
|
||||||
|
Current
liabilities
|
$
|
10,723
|
$
|
9,226
|
||
|
Long-term
portion of deferred revenue and other long-term
liabilities
|
11,055
|
14,064
|
||||
|
Stockholders’
equity
|
72,350
|
86,842
|
||||
|
Total
liabilities and stockholders’ equity
|
$
|
94,128
|
$
|
110,132
|
||
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
For
the
three months and year ended June 30, 2006 and 2005
|
Three
Months
Ended
June
30,
|
Year
Ended
June
30,
|
||||||||||||
|
2006
|
2005
|
2006
|
2005
|
||||||||||
|
Revenues:
|
|||||||||||||
|
Research
and
development support
|
$
|
5,675
|
$
|
4,668
|
$
|
21,849
|
$
|
18,419
|
|||||
|
License
and
milestone fees
|
1,340
|
1,160
|
7,151
|
6,776
|
|||||||||
|
Clinical
materials reimbursement
|
1,354
|
1,606
|
3,088
|
10,523
|
|||||||||
|
Total
revenues
|
8,369
|
7,434
|
32,088
|
35,718
|
|||||||||
|
Expenses:
|
|||||||||||||
|
Cost
of
clinical materials reimbursed
|
890
|
1,414
|
2,668
|
9,236
|
|||||||||
|
Research
and
development (1)
|
12,441
|
6,880
|
40,908
|
30,539
|
|||||||||
|
General
and
administrative (1)
|
2,580
|
2,407
|
9,898
|
8,620
|
|||||||||
|
Total
operating expenses
|
15,911
|
10,701
|
53,474
|
48,395
|
|||||||||
|
Loss
from
operations
|
(7,542
|
)
|
(3,267
|
)
|
(21,386
|
)
|
(12,677
|
)
|
|||||
|
Other
income,
net
|
897
|
549
|
3,569
|
1,755
|
|||||||||
|
Income
(loss)
before taxes
|
(6,645
|
)
|
(2,718
|
)
|
(17,817
|
)
|
(10,922
|
)
|
|||||
|
Income
tax
expense
|
-
|
2
|
17
|
29
|
|||||||||
|
Net
income
(loss)
|
$
|
(6,645
|
)
|
$
|
(2,720
|
)
|
$
|
(17,834
|
)
|
$
|
(10,951
|
)
|
|
|
Basic
and diluted net loss per common share
|
$
|
(0.16
|
)
|
$
|
(0.07
|
)
|
$
|
(0.43
|
)
|
$
|
(0.27
|
)
|
|
|
Basic
and diluted weighted average common shares
outstanding
|
41,409
|
41,013
|
41,184
|
40,868
|
|||||||||
|
(1)
Stock
compensation is included in the following categories during the
three
months and year ended June 30, 2006 and 2005:
|
|||||||||||||
|
2006
|
|
2005
|
2006
|
2005
|
|||||||||
|
Research
and
development
|
$
|
359
|
$
|
-
|
$
|
1,439
|
$
|
-
|
|||||
|
General
and
administrative
|
226
|
46
|
985
|
176
|
|||||||||
|
$
|
585
|
$
|
46
|
$
|
2,424
|
$
|
176
|
||||||
5