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): November 3, 2005
ImmunoGen,
Inc.
(Exact
name of registrant as specified in its charter)
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Massachusetts
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0-17999
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04-2726691
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||
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(State
or other jurisdiction of incorporation)
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(Commission
File Number)
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(IRS
Employer Identification No.)
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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
November 3, 2005, ImmunoGen, Inc. (Nasdaq: IMGN) issued a press release to
announce the company’s financial results for the quarter ended September 30,
2005. 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
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Exhibit
No.
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Exhibit
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99.1
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Press
Release of ImmunoGen, Inc. dated November 3,
2005
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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.
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(Registrant)
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Date:
November 3, 2005
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/s/
Karleen M. Oberton
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Karleen
M. Oberton
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|
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Senior
Corporate Controller
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(Principal
Accounting Officer)
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3
128
Sidney Street, Cambridge, MA 02139-4239TEL:
(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 First Quarter Fiscal Year 2006 Financial
Results
-
Company
Provides Business Update -
CAMBRIDGE,
MA, November 3, 2005
-
ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops
targeted anticancer therapeutics, today announced financial results for the
three-month period ended September 30, 2005 - the first quarter of the Company’s
2006 fiscal year.
For
the
three-month period ended September 30, 2005, the Company reported a net loss
of
$4.7 million, or $0.11 per basic and diluted share, compared to a net loss
of
$2.5 million, or $0.06 per basic and diluted share, in the same three-month
period last year. The first quarter 2006 financial results include $0.6 million
of stock compensation expense -
equal to
approximately $0.01 per share - reflecting 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.
Revenues
for the three-month period ended September 30, 2005 were $7.8 million, compared
to $9.0 million for the same period last year. The first quarter 2006 revenues
include $5.6 million of research and development support fees as compared to
$4.1 million for the same period last year. For the first quarter 2006, these
support fees primarily represent funding earned pursuant to the Company’s
discovery, research, and commercialization collaboration with the sanofi-aventis
Group as well as funding earned under the Company’s development and license
agreements with Biogen Idec and Centocor. Of the $5.6 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
billed in fiscal 2006. The first quarter 2006 revenues also include
$0.8 million of clinical material reimbursement compared to $2.9 million
for the same period last year - revenue related to the production and supply
of
clinical materials to the Company’s collaborators. In both periods, the
reimbursement revenue was derived from multiple TAP compounds; however, the
first quarter 2005 revenue included substantial quantities of bivatuzumab
mertansine not repeated in the first quarter 2006. The first quarter 2006
revenues include $1.3 million of license and milestone fees as compared to
ImmunoGen,
Inc. First Quarter Fiscal Year 2006 Financial Results
Page
2
of
6
$1.5
million for the same period last year.
Operating
expenses for the three-month period ended September 30, 2005 were
$13.2 million, compared to $11.8 million for the same period last year.
The
first quarter 2006 operating expenses include research and development expenses
of $9.5 million, compared to $7.6 million for the same period last year. The
increase in research and development expenses is primarily the result of less
manufacturing overhead being charged to collaborators due to reduced clinical
material being produced for our collaborators, and to 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). The cost of clinical material reimbursed was $0.9 million in the first
quarter 2006 as compared with $2.5 million for the same period last year. The
first quarter 2006 operating expenses also include general and administrative
expenses of $2.8 million as compared to $1.7 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, substantially comprised of interest income, was $0.7 million in the
three-month period ended September 30, 2005, compared to $0.4 million for the
same period last year. The increased interest income in the first quarter 2006
was attributable to higher rates of return on investments compared with the
same
period last year.
ImmunoGen
had approximately $86.8 million in cash and marketable securities on September
30, 2005, compared with $90.6 million as of June 30, 2005. During the first
quarter 2006, cash used in operations was $3.5 million, compared to $0.9 million
provided by operations 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
quarter 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, Ph.D., Chairman and CEO, commented, “This summer we doubled, from two to
four, the number of clinical trials underway with our own compounds as we
advanced our huC242-DM4 into clinical testing and initiated a third study with
our huN901-DM1 - a study to assess the compound for use in the treatment of
multiple myeloma. Solid progress also is being made in the two clinical trials
underway to evaluate huN901-DM1 for the treatment of small-cell lung cancer,
and
we’ll report the first data from the Phase I study in which the compound is
dosed daily for three days every three weeks at the AACR-NCI-EORTC conference
later this month. Additionally, three of our partners will present data on
TAP
compounds at this conference. Other key achievements over the past three months
include the agreement reached with the sanofi-aventis Group to extend the
duration of our research collaboration for another year, which will provide
ImmunoGen with an additional $18.2 million in research support
funding.”
ImmunoGen’s
Tumor-Activated Prodrug (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.
2
ImmunoGen,
Inc. First Quarter Fiscal Year 2006 Financial Results
Page
3
of
6
Update
on ImmunoGen Product Candidates in Clinical Testing
HuN901-DM1
This
TAP
compound targets the CD56 antigen found on small-cell lung cancers (SCLC),
other
cancers of neuroendocrine origin, and certain hematological malignancies
including many cases of multiple myeloma. Three clinical trials are underway
with huN901-DM1.
| · |
Multiple
myeloma Phase I trial - In September 2005, the Company announced
the
initiation of patient dosing in a Phase I study evaluating huN901-DM1
in
the treatment of multiple myeloma. The primary objective of this
dose-escalation study is to evaluate the safety of huN901-DM1 in
patients
with relapsed or refractory multiple myeloma, and to identify the
maximum
tolerated dose of the compound in this patient population. The study
also
will evaluate the anticancer activity of huN901-DM1 in multiple
myeloma.
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| · |
SCLC
Phase I trial - Interim clinical data from this Phase I trial will
be
presented at the AACR-NCI-EORTC International Conference on Molecular
Targets and Cancer Therapeutics being held November 14 through 18,
2005 in
Philadelphia, PA. The poster presentation will be on Wednesday, November
16; meeting abstracts are expected to be available on the Conference
website (www.aacr.org)
on November 14.
|
The
primary objective of this dose-escalation study is to evaluate the safety of
huN901-DM1 when administered daily for three consecutive days in a 21-day cycle
to patients with SCLC or other CD56-expressing solid tumors, and to establish
its maximum tolerated dose. Information on the clinical activity of the compound
also is collected and will be reported.
| · |
SCLC
Phase I/II trial - Substantially more clinical centers have been
added to
this study over the past few months. The enrollment target for the
Phase
II portion of this trial was expanded earlier this year - from fourteen
patients to thirty-five patients - because objective evidence of
anticancer activity was reported among the initial patients treated.
In
this study, patients with relapsed SCLC receive huN901-DM1 weekly
for four
weeks in a 6-week cycle.
|
Each
of
the studies underway with huN901-DM1 evaluates the compound as monotherapy.
SCLC
is typically treated with a combination of anticancer agents. Preclinical data
on the effect of combining huN901-DM1 with other agents commonly used to treat
SCLC will be presented in a poster at the AACR-NCI-EORTC conference in
November.
HuC242-DM4
This
TAP
compound 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. Preclinical
pharmacokinetic data will be reported on huC242-DM4 at the upcoming
AACR-NCI-EORTC conference.
3
ImmunoGen,
Inc. First Quarter Fiscal Year 2006 Financial Results
Page
4 of
6
Update
on ImmunoGen Collaborations
ImmunoGen
expects three of its collaborative partners to have poster presentations on
TAP
compounds at the upcoming AACR-NCI-EORTC conference. The presentations will
include clinical data on bivatuzumab mertansine and preclinical findings with
other TAP compounds.
In
August
2005, the sanofi-aventis Group exercised its right to extend the term of its
research collaboration and committed to fund ImmunoGen $18.2 million in research
support over the twelve months beginning September 1, 2006. This funding is
in
addition to the research support already committed to ImmunoGen for the three
years ending August 31, 2006. The sanofi-aventis Group can extend the research
collaboration for one additional year - the year beginning September 1,
2007.
Webcast
Information
A
live
conference call and webcast are scheduled for today, November 3, 2005 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 November
3, 2005 through 11:59 p.m. on November 9, 2005. To listen to the playback,
call
719-457-0820 and provide passcode 1142879. 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 November 9, 2005.
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 MLN2704
and
AVE9633, which are in development by Millennium Pharmaceuticals, Inc. and the
sanofi-aventis Group, respectively. 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
4
ImmunoGen,
Inc. First Quarter Fiscal Year 2006 Financial Results
Page
5 of
6
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-
5
ImmunoGen,
Inc. First Quarter Fiscal Year 2006 Financial Results
Page 6
of 6
SELECTED
FINANCIAL INFORMATION
(in
thousands, except per share amounts)
CONDENSED
CONSOLIDATED BALANCE SHEETS
As
of September 30, 2005 and June 30, 2005
(Unaudited)
|
September
30,
|
June
30,
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||||||
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2005
|
2005
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||||||
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ASSETS
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|||||||
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Cash
and marketable securities
|
$
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86,824
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$
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90,565
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|||
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Other
assets
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19,432
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19,567
|
|||||
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Total
assets
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$
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106,256
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$
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110,132
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|||
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LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
|
Current
liabilities
|
$
|
9,436
|
$
|
9,226
|
|||
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Long
term portion of deferred revenue and other long term
liabilities
|
13,849
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14,064
|
|||||
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Stockholders’
equity
|
82,971
|
86,842
|
|||||
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Total
liabilities and stockholders’ equity
|
$
|
106,256
|
$
|
110,132
|
|||
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
For
the three months ended September 30, 2005 and 2004
|
Three
Months Ended September 30,
|
|||||||
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2005
|
2004
|
||||||
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(Unaudited)
|
(Unaudited)
|
||||||
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Revenues:
|
|||||||
|
Research
and development support
|
$
|
5,645
|
$
|
4,089
|
|||
|
License
and milestone fees
|
1,261
|
1,542
|
|||||
|
Clinical
materials reimbursement
|
831
|
2,866
|
|||||
|
Development
fees
|
41
|
510
|
|||||
|
Total
revenues
|
7,778
|
9,007
|
|||||
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Expenses:
|
|||||||
|
Cost
of clinical materials reimbursed
|
904
|
2,494
|
|||||
|
Research
and development (1)
|
9,492
|
7,631
|
|||||
|
General
and administrative (1)
|
2,794
|
1,717
|
|||||
|
Total
operating expenses
|
13,190
|
11,842
|
|||||
|
Loss
from operations
|
(5,412
|
)
|
(2,835
|
)
|
|||
|
Other
income, net
|
716
|
368
|
|||||
|
Income
(loss) before taxes
|
(4,696
|
)
|
(2,467
|
)
|
|||
|
Income
tax expense
|
10
|
3
|
|||||
|
Net
income (loss)
|
$
|
(4,706
|
)
|
$
|
(2,470
|
)
|
|
|
Net
income (loss) per common share, basic and diluted
|
$
|
(0.11
|
)
|
$
|
(0.06
|
)
|
|
|
Average
common shares outstanding, basic and diluted
|
41,065
|
40,789
|
|||||
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(1)
Stock compensation is included in the following categories during
the
three months ended September 30, 2005 and 2004:
|
|||||||
|
2005
|
2004
|
||||||
|
Research
and development
|
$
|
352
|
$
|
-
|
|||
|
General
and administrative
|
354
|
3
|
|||||
|
$
|
706
|
3
|
|||||
6