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 2, 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
November 2, 2006, ImmunoGen, Inc. (Nasdaq: IMGN) issued a press release to
announce the company’s financial results for the quarter ended September 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 November 2,
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:
November 2,
2006
|
/s/
Daniel M.
Junius
|
|
Daniel
M.
Junius
|
|
|
Executive
Vice
President and Chief Financial Officer
|
|
3
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
ImmunoGen,
Inc.
(617)
995-2500
info@immunogen.com
|
Media:
Kathryn
Morris
KMorrisPR
(845)
635-9828
Kathryn@kmorrispr.com
|
For
Immediate
Release
ImmunoGen,
Inc.
Reports First Quarter Fiscal Year 2007 Financial Results
-
Company
Provides
Business Update -
CAMBRIDGE,
MA,
November 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-month period ended September 30, 2006 - the
first quarter of the Company’s 2007 fiscal year.
“Our
recent developments and upcoming events reflect the many activities underway
at
ImmunoGen and with our collaborators,” commented Mitchel Sayare, Chairman and
CEO of ImmunoGen. “We’ll report initial clinical findings for our huC242-DM4
product candidate at the EORTC conference next week and are on track to begin
Phase II evaluation of this compound by mid-2007. Next week we’ll also
present additional clinical data on our huN901-DM1 compound in the treatment
of
solid tumors and then, in early December, we’ll report the first data from the
study evaluating it in the treatment of the liquid tumor, multiple myeloma.”
Dr.
Sayare continued, “Progress by our collaborators included initiation of clinical
testing of AVE1642 by sanofi-aventis. This is the second compound to advance
into the clinic through our discovery, development and commercialization
collaboration with them. We’re pleased that sanofi-aventis exercised its second
option to extend the duration of the research portion of this collaboration
-
which will provide us with committed funding through August 2008 - and that
they
licensed broader access to our humanization technology.”
For
the three-month period ended September 30, 2006, ImmunoGen reported a net
loss
of $6.3 million, or $0.15 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.
Revenues for
the three-month period ended September 30, 2006 were $7.8 million, which is
consistent with the amount recorded in the same period last year. The first
quarter fiscal 2007 revenues include $5.5 million of research and
development support fees, compared to $5.7 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 sanofi-aventis and, to a lesser extent, funding earned under the Company’s
development and license agreements with other of its collaborative partners.
Of
the $5.7 million reported in the first quarter of fiscal 2006, $1.1 million
represents funding related to research and development efforts performed during
the Company’s 2005 fiscal year under the sanofi-aventis collaboration but billed
and recognized in fiscal 2006. The first quarter fiscal 2007 revenues also
include $1.4 million of license and milestone fees and $0.9 million of
clinical material reimbursement, compared to $1.3 million and $0.8 million,
respectively, 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.
Operating
expenses for the
three-month period ended September 30, 2006 were $14.9 million, compared to
$13.2 million for the same period last year. The first quarter 2007 operating
expenses include research and development expenses of $11.4 million, compared
to
$9.5 million for the same period last year. The increase was driven
primarily by an incremental $1.9 million for manufacturing and process
development activity related to the production of the ImmunoGen compounds
in
clinical testing. The cost of clinical materials reimbursed was $0.6 million
in
the first quarter fiscal 2007 as compared to $0.9 million for the same
period last year. The first quarter fiscal 2007 operating expenses also include
general and administrative expenses of $2.8 million, the same amount as was
recorded in the comparable period last year.
Other
income, primarily consisting of interest income, was $0.8 million in the
three-month period ended September 30, 2006, compared to $0.7 million for
the
same period last year.
ImmunoGen
had
approximately $70.3 million in cash and marketable securities as of September
30, 2006, compared with $75.0 million as of June 30, 2006, and had no
outstanding debt in either period. During the first quarter 2007, cash used
in
operations was $4.6 million, compared to $3.5 million during the same period
last year.
"The
extension by sanofi-aventis of the research collaboration between our companies
provides ImmunoGen with significant committed research funding through August
2008,” noted Daniel Junius, Executive Vice President, Finance, and CFO. “Our
many collaborations continue to be a strong source of non-dilutive funding
that
allows us to develop our own compounds while reducing our cash burn. At the
same
time, we continue to be disciplined in managing our operations, as can be
seen
from these quarterly results.”
2
Corporate
Update
ImmunoGen’s
HuN901-DM1 Product Candidate
New
clinical data will be reported from the Company’s ongoing Study 002 on
November 10, 2006 at the 18th
EORTC-NCI-AACR
International Conference on Molecular Targets and Cancer Therapeutics (EORTC)
in
Prague. This Phase I trial is evaluating huN901-DM1 administered daily for
three
consecutive days in a 21-day cycle to patients with CD56-expressing solid
tumors
such as small-cell lung cancer (SCLC). Increasing amounts of the compound
are
administered in this dose-escalation trial to new cohorts of patients until
dose-limiting toxicity is encountered. To date, the level of toxicity associated
with the compound has been insufficient to establish its maximum tolerated
dose
(MTD) and thus dose escalation is ongoing. The poster presented at the
conference will include all of the Study 002 data available at that time.
Additionally,
the Company
will report the first clinical data from its Study 003 on December 11, 2006
at
the American Society of Hematology (ASH) annual meeting to be held in Orlando,
FL. This Phase I dose-escalation trial evaluates the compound in patients
with
CD56-expressing multiple myeloma that have relapsed after treatment with
approved therapies. Dose escalation also is ongoing in this study.
In
2005, the Company’s Study 001 was expanded to include 35 patients. The majority
of these patients have been enrolled, and ImmunoGen expects to report additional
data from this study in 2007.
HuN901-DM1
is wholly-owned
by ImmunoGen and targets the CD56 antigen found on SCLC, other cancers of
neuroendocrine origin, and certain hematological malignancies including multiple
myeloma. It
comprises ImmunoGen’s huN901 antibody and DM1 maytansinoid cell-killing agent.
The huN901 antibody functions to deliver the compound specifically to the
cancer
cells and the DM1 component serves to kill those cells.
ImmunoGen’s
HuC242-DM4 Product Candidate
Initial
clinical data for
huC242-DM4 will be reported at the EORTC conference on November 8, 2006.
HuC242-DM4 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. The MTD for the compound has not yet been
established and patient enrollment is ongoing. The poster presentation will
include the data available at the time of the conference.
To
be
eligible for enrollment, patients need to have CanAg-expressing cancers that
have relapsed after treatment with the approved therapies. During the
dose-escalation portion of the study, patients with any level of CanAg
expression are eligible for enrollment. After the MTD is established, only
patients with tumors that have strong, homogenous CanAg expression will be
enrolled.
HuC242-DM4
comprises the
Company’s CanAg-targeting antibody, huC242, and its DM4 cell-killing agent. This
compound also is wholly-owned by ImmunoGen.
3
Collaborations
Update
ImmunoGen
has
collaborations with a number of companies, including Amgen (formerly Abgenix),
Biogen Idec, Biotest AG, Boehringer Ingelheim, Centocor (Johnson & Johnson),
Genentech, Millennium Pharmaceuticals, Inc., and sanofi-aventis. Three compounds
are in clinical testing through these collaborations - trastuzumab-DM1, in
development by Genentech, and AVE9633 and AVE1642, in development by
sanofi-aventis.
Patient
dosing with
AVE1642 began in October 2006, and ImmunoGen earned a $2 million milestone
payment from sanofi-aventis with this event. AVE1642 is a naked (nonconjugated)
antibody that binds to and blocks the insulin-like growth factor 1 receptor
(IGF-1R). Both AVE1642 and AVE9633, a TAP compound for acute myeloid leukemia,
were initially developed by ImmunoGen and licensed to sanofi-aventis from
the
Company’s preclinical portfolio as part of a discovery, development, and
commercialization collaboration established between the companies in
2003.
In
August 2006, sanofi-aventis exercised the second of its two options to extend
the duration of the research portion of this collaboration, committing to
provide ImmunoGen with significant research support funding through August
2008.
As part of these negotiations, it was agreed that, effective September 2006,
the
Company no longer needs to present new targets for antibody-based anticancer
therapeutics to sanofi-aventis, enabling ImmunoGen to use such targets in
the
development of its own proprietary compounds. Through and after the completion
of the research collaboration, the Company continues to be entitled to receive
significant milestone payments from each collaboration compound, royalties
on
sales, and manufacturing payments for materials made on behalf of
sanofi-aventis; the Company also has certain co-promotion rights on a
product-by-product basis.
After
the completion of the research collaboration, sanofi-aventis will need to
license the right to use ImmunoGen’s maytansinoid TAP technology with antibodies
to targets that were not part of the collaboration. In August 2006, the
companies also agreed to negotiate a multi-target agreement to provide
sanofi-aventis with access to ImmunoGen’s maytansinoid TAP technology after
August 2008.
Additionally,
in October
2006, sanofi-aventis licensed non-exclusive rights to use ImmunoGen’s
proprietary resurfacing technology to humanize antibodies that fall outside
of
the research collaboration. In 2003, sanofi-aventis gained rights to use
the
Company’s resurfacing technology to humanize the antibodies in the anticancer
compounds included in the collaboration. The agreement established in October
2006 allows sanofi-aventis to be able to use the technology now to humanize
antibodies in development for non-oncology applications and also to be able
to
continue to use it with oncology antibodies after the completion of the research
collaboration in 2008. Under this agreement, ImmunoGen earned a $1 million
license fee, of which half is due upon contract signing, and is entitled
to
receive milestone payments potentially totaling $4.5 million plus royalties
on sales for each compound humanized under this agreement.
4
Webcast
Information
A
conference call is scheduled for today, November 2, 2006 at 4:30 pm (EST).
The call will include management discussion of financial results and provide
an
update on ImmunoGen. To
access the live call by
phone, dial 913-981-4900. No passcode is required. 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, 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. Five anticancer compounds are in clinical testing
through ImmunoGen and the Company’s collaborators - huN901-DM1 and huC242-DM4,
which are wholly owned by ImmunoGen, AVE9633 and AVE1642, in development
by
sanofi-aventis, and trastuzumab-DM1, in development by Genentech. Amgen
(formerly Abgenix), Biogen Idec, Biotest AG, Boehringer Ingelheim, Centocor,
Genentech, Millennium Pharmaceuticals, Inc., and sanofi-aventis have licensed
the right to develop and/or test TAP compounds to specific targets; ImmunoGen
also has a broader collaboration with sanofi-aventis.
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, 2006 and other
reports filed with the Securities and Exchange Commission.
-financials
follow-
5
SELECTED
FINANCIAL INFORMATION
(in
thousands, except per share amounts)
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
September
30,
|
June
30,
|
||||||
|
2006
|
2006
|
||||||
|
(Unaudited)
|
|||||||
|
ASSETS
|
|||||||
|
Cash
and
marketable securities
|
$
|
70,276
|
$
|
75,023
|
|||
|
Other
assets
|
19,741
|
19,105
|
|||||
|
Total
assets
|
$
|
90,017
|
$
|
94,128
|
|||
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
|
Current
liabilities
|
$
|
12,364
|
$
|
10,723
|
|||
|
Long-term
portion of deferred revenue and other long-term
liabilities
|
10,668
|
11,055
|
|||||
|
Stockholders’
equity
|
66,985
|
72,350
|
|||||
|
Total
liabilities and stockholders’ equity
|
$
|
90,017
|
$
|
94,128
|
|||
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
Three
Months Ended
September
30,
|
|||||||
|
2006
|
2005
|
||||||
|
(Unaudited)
|
(Unaudited)
|
||||||
|
Revenues:
|
|||||||
|
Research
and
development support
|
$
|
5,507
|
$
|
5,685
|
|||
|
License
and
milestone fees
|
1,406
|
1,261
|
|||||
|
Clinical
materials reimbursement
|
857
|
831
|
|||||
|
Total
revenues
|
7,770
|
7,777
|
|||||
|
Expenses:
|
|||||||
|
Cost
of
clinical materials reimbursed
|
646
|
905
|
|||||
|
Research
and
development
|
11,416
|
9,492
|
|||||
|
General
and
administrative
|
2,797
|
2,793
|
|||||
|
Total
operating expenses
|
14,859
|
13,190
|
|||||
|
Loss
from
operations
|
(7,089
|
)
|
(5,413
|
)
|
|||
|
Other
income,
net
|
846
|
717
|
|||||
|
Income
(loss)
before taxes
|
(6,243
|
)
|
(4,696
|
)
|
|||
|
Income
tax
expense
|
10
|
10
|
|||||
|
Net
income
(loss)
|
$
|
(6,253
|
)
|
$
|
(4,706
|
)
|
|
|
Net
income (loss) per common share, basic and diluted
|
$
|
(0.15
|
)
|
$
|
(0.11
|
)
|
|
|
Average
common shares
outstanding, basic and diluted
|
41,482
|
41,065
|
|||||
6