-
Marketing applications submitted for trastuzumab emtansine (T-DM1)
in the US and Europe.
-
Meaningful clinical data expected to be reported in coming year —
for ImmunoGen compounds, T-DM1, and other partner compounds.
-
ImmunoGen well positioned to advance its wholly owned compounds at
least through proof-of-concept.
WALTHAM, Mass.--(BUSINESS WIRE)--
ImmunoGen,
Inc. (Nasdaq: IMGN), a
biopharmaceutical company that develops anticancer products using its
Targeted Antibody Payload (TAP) technology and antibody expertise, today
reported financial results for the three-month period ended September
30, 2012 — the first quarter of the Company's 2013 fiscal year — and
provided an update on the Company.
"In the past few months, the results from the T-DM1 Phase III EMILIA
trial have been used as the basis for Roche's marketing submissions,
reported in oral presentations at ASCO and ESMO, and published in the New
England Journal of Medicine," commented Daniel Junius, President and
CEO. "Roche has continued to expand the potential commercial opportunity
for T-DM1, into earlier stages of HER2+ breast cancer and now also into
HER2+ gastric cancer. We believe T-DM1 has the potential to rapidly
become a highly successful product that makes a real difference for
appropriate patients."
Mr. Junius continued, "Many other, earlier stage TAP compounds are also
making meaningful progress. Of particular importance, we now have three
wholly owned TAP compounds in clinical testing, and expect to submit an
IND for our fourth by mid-2013. We believe the potential value of these
TAP compounds will become more apparent over the course of 2013."
Product Pipeline Update
-
T-DM1, in global development by Roche:
-
Marketing applications submitted for lead indication — In August,
Roche applied for marketing approval in the US and Europe of T-DM1
for the treatment of HER2+ metastatic breast cancer (BC) in
patients who had previously received Herceptin®. T-DM1 was found
to significantly improve both overall survival and
progression-free survival compared to standard-of-care in the
EMILIA Phase III trial and was associated with fewer Grade 3 or
greater (severe) adverse events.
-
Progress in Phase III trial, MARIANNE, for first-line treatment of
HER2+ metastatic BC — Patient enrollment was completed this
spring, and Roche now expects data from this trial in late
2013/early 2014, which is earlier than originally projected.
-
Registration trials in early stage HER2+ BC on track to start in
2013 — Roche plans to evaluate T-DM1 for neoadjuvant use, for
adjuvant use and for treatment of residual invasive disease
following surgery.
-
Assessment for metastatic HER2+ gastric cancer underway — Roche
has initiated a trial assessing T-DM1 for second-line treatment of
this disease and expects to apply for marketing approval for this
use in 2015.
-
IMGN901, ImmunoGen's lead wholly owned compound:
-
Patient enrollment progressing in NORTH trial —Thirty-three sites
across four countries are now participating in this randomized
Phase II trial assessing IMGN901 as part of a combination regimen
for first-line treatment of small-cell lung cancer. The Company
expects to report the first findings from this Phase II assessment
in the second half of 2013. Findings from its dose-finding Phase I
assessment were reported at medical meetings in September and
October.
-
Multiple myeloma data to be presented at American Society of
Hematology (ASH) annual meeting— Data from the Phase I trial
assessing IMGN901 as part of a combination regimen for this cancer
will be reported in an oral presentation at the ASH annual meeting
in December.
-
IMGN853, ImmunoGen's wholly owned folate receptor α (FOLR)-targeting
TAP compound:
-
Patient enrollment in the Phase I trial is underway at several
sites in the US.
-
ImmunoGen expects to report the first clinical data with IMGN853
in 2013.
-
IMGN529, ImmunoGen's wholly owned TAP compound for non-Hodgkin's
lymphoma:
-
The study protocol was successfully amended to allow use of
single-patient cohorts during dose escalation.
-
Patient enrollment is underway at an expanding number of clinical
centers.
-
ImmunoGen expects to report the first clinical data with IMGN529
in 2013.
-
Other clinical-stage compounds — In addition to T-DM1, seven other
compounds are in clinical testing through ImmunoGen's collaborative
partnerships.
-
The Company expects clinical data to be reported for most, if not
all, of these compounds in 2013.
Financial Results and Guidance
ImmunoGen reported a net loss of $25.2 million, or $0.30 per basic and
diluted share, for the quarter ending September 30, 2012 (1Q FY2013), as
compared to a net loss of $19.5 million, or $0.26 per basic and diluted
share, for the same quarter of the last year (1Q FY2012).
Revenues were $4.1 million for 1Q FY2013, as compared to $2.5 million
for the same period last year. Revenues in 1Q FY2013 include $1.4
million of research and development support fees and $0.9 million of
license and milestone fees, compared to $1.1 million and $1.2 million
respectively, for the same quarter last year. Revenues in 1Q FY2013 also
include $1.8 million of clinical material reimbursement, compared to
$0.3 million for 1Q FY2012. The difference in clinical material
reimbursement from the prior year period is primarily due to variability
in the number of batches released to partners on a quarter-by-quarter
basis.
Operating expenses for 1Q FY2013 were $29.3 million, compared to $22.0
million in the same quarter last year. Operating expenses in 1Q FY2013
include research and development expenses of $23.7 million, compared to
$17.2 million in 1Q FY2012. This increase is primarily due to greater
investment by the Company in aggressively advancing its wholly owned
product candidates. It includes increased third-party costs to produce
finished drug product for clinical use, increased personnel expenses,
particularly stock compensation expense, and increased clinical trial
costs. Operating expenses also include general and administrative
expenses of $5.6 million in 1Q FY2013, compared to $4.8 million in 1Q
FY2012. This increase is primarily due to increased personnel expenses,
particularly stock compensation expense, and increased patent expenses.
ImmunoGen had approximately $233.6 million in cash and cash equivalents
as of September 30, 2012 — inclusive of $94 million in net proceeds from
the Company's public stock offering in July 2012 — compared with $160.9
million as of June 30, 2012, and had no debt outstanding in either
period. Cash used in operations was $21.0 million in 1Q FY2013, compared
with $11.6 million in 1Q FY2012. Capital expenditures were $1.0 million
and $0.6 million for the first three months of FY2013 and FY2012,
respectively.
ImmunoGen's financial guidance remains unchanged from that issued in
August 2012. ImmunoGen expects its net loss for its fiscal year ending
June 30, 2013 to be between $70 million to $74 million, its net cash
used in operations to be between $78 million to $82 million, and its
capital expenditures to be between $4 million to $5 million. Cash and
cash equivalents at June 30, 2013 are anticipated to be between $172
million to $176 million.
"We believe that approval and launch of T-DM1 will begin a new era in
the treatment of HER2+ cancer," commented Gregory Perry, Executive Vice
President and CFO. "It also will result in ImmunoGen starting to receive
royalty revenue. We anticipate our current cash position, combined with
the inflow of cash expected to be received from this and other of our
partnerships, provides us with the financial resources needed to
successfully advance our wholly owned products to proof-of-concept, at
which point we have a number of development options."
Conference Call Information
ImmunoGen is holding a conference call today at 8:00 am ET to discuss
the quarterly results. To access the live call by phone, dial
913-312-1472. Passcode is 4483380. The call also may be accessed through
the Investor Information section of the Company's website, www.immunogen.com.
Following the live webcast, a replay of the call will be available at
the same location through November 9, 2012.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using the
Company's expertise in tumor biology, monoclonal antibodies, potent
cancer-cell killing agents and engineered linkers. The Company's TAP
technology uses monoclonal antibodies to deliver one of ImmunoGen's
proprietary cancer-killing agents specifically to tumor cells. There are
now ten TAP compounds in clinical development, of which three are wholly
owned by the Company. Marketing applications for trastuzumab emtansine
(T-DM1), the most advanced compound using ImmunoGen's TAP technology,
have been submitted in the US and Europe. Roche is developing this
compound globally under an agreement between ImmunoGen and Genentech, a
member of the Roche Group. More information about ImmunoGen can be found
at www.immunogen.com.
Herceptin® is a registered trademark of Genentech.
This press release includes forward-looking statements based on
management's current expectations. These statements include, but are not
limited to, ImmunoGen's expectations related to: the Company's net loss,
cash used in operations and capital expenditures in its 2013 fiscal
year; its cash and marketable securities as of June 30, 2013; the
occurrence, timing and outcome of potential pre-clinical, clinical and
regulatory events related to the Company's and its collaboration
partners' product programs; and the presentation of preclinical and
clinical data on the Company's and collaboration partners' product
candidates. 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
ImmunoGen'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 timing and outcome of ImmunoGen's and 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, clinical trials and regulatory
processes; ImmunoGen's ability to financially support its product
programs; ImmunoGen's dependence on collaborative partners; industry
merger and acquisition activity; and other factors more fully described
in ImmunoGen's Annual Report on Form 10-K for the fiscal year ended June
30, 2012 and other reports filed with the Securities and Exchange
Commission.
|
|
|
|
|
IMMUNOGEN, INC.
|
|
SELECTED FINANCIAL INFORMATION
|
|
(in thousands, except per share amounts)
|
|
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
(Unaudited)
|
|
|
|
|
|
|
|
September 30,
|
|
|
June 30,
|
|
|
|
|
|
2012
|
|
|
2012
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
$
|
233,614
|
|
|
$
|
160,938
|
|
Other assets
|
|
|
|
|
19,054
|
|
|
|
19,370
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
|
|
$
|
252,668
|
|
|
$
|
180,308
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
$
|
15,428
|
|
|
$
|
16,254
|
|
Long-term portion of deferred revenue and other long-term liabilities
|
|
|
|
|
79,928
|
|
|
|
80,164
|
|
Shareholders' equity
|
|
|
|
|
157,312
|
|
|
|
83,890
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders' equity
|
|
|
|
$
|
252,668
|
|
|
$
|
180,308
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
(Unaudited)
|
|
|
|
|
|
Three Months Ended
|
|
|
|
|
|
September 30,
|
|
|
|
|
|
|
2012
|
|
|
|
2011
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
Research and development support
|
|
|
|
$
|
1,377
|
|
|
$
|
1,068
|
|
License and milestone fees
|
|
|
|
|
933
|
|
|
|
1,187
|
|
Clinical materials reimbursement
|
|
|
|
|
1,781
|
|
|
|
281
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
|
|
4,091
|
|
|
|
2,536
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
23,700
|
|
|
|
17,161
|
|
General and administrative
|
|
|
|
|
5,639
|
|
|
|
4,841
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
|
|
29,339
|
|
|
|
22,002
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
|
|
(25,248)
|
|
|
|
(19,466)
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net
|
|
|
|
|
56
|
|
|
|
(17)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
$
|
(25,192)
|
|
|
$
|
(19,483)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted
|
|
|
|
$
|
(0.30)
|
|
|
$
|
(0.26)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding, basic and diluted
|
|
|
|
|
83,350
|
|
|
|
76,364
|
For Investors:
ImmunoGen, Inc.
Carol Hausner, 781-895-0600
Executive
Director, Investor Relations and Corporate Communications
info@immunogen.com
or
For
Media:
The Yates Network
Barbara Yates, 781-258-6153
Source: ImmunoGen, Inc.
News Provided by Acquire Media