ImmunoGen, Inc. (Nasdaq: IMGN), a
biotechnology company that develops targeted anticancer products
using its antibody expertise and Targeted Antibody Payload (TAP)
technology, today reported financial results for the three-month
period ended March 31, 2012 – the third quarter of the Company’s
2012 fiscal year – and provided an update on ImmunoGen.
“The progress being made by us and our partners is
accelerating,” commented Daniel Junius, President and CEO. “Roche
has announced trastuzumab emtansine met the PFS endpoint in the
lead Phase III trial, EMILIA. Sanofi has submitted SAR3419 data to
ASCO for presentation and is evaluating it in multiple Phase II
trials. And we have had visible progress with our lead wholly owned
compounds, advancing IMGN901 into Phase II testing, IMGN529 into
Phase I testing and IMGN853 to having an active IND.”
Mr. Junius continued, “At the upcoming ASCO meeting in June, we
expect to see not only EMILIA Phase III data and new SAR3419 Phase
I data, but also data from the Phase II trial evaluating the safety
of trastuzumab emtansine in the adjuvant/neoadjuvant setting.
Looking beyond ASCO, we expect to begin clinical testing with our
IMGN853 product candidate in mid-2012 and for Roche to apply for
marketing approval of trastuzumab emtansine this year.”
Product Pipeline Progress – Key Updates
Lead compound, trastuzumab
emtansine, which is in development by Roche under an
agreement with ImmunoGen:
- For HER2+ metastatic breast cancer
(mBC) – Roche reported that the PFS endpoint was met in the EMILIA
Phase III trial and that it will apply in 2012 for marketing
approval of trastuzumab emtansine in the US and Europe. EMILIA
evaluates the compound for the treatment of patients with HER2+ mBC
who previously had received trastuzumab (Herceptin®) and a taxane
in any setting (adjuvant or metastatic).
- Roche reported that the study data were
submitted to ASCO for presentation at the annual meeting in
June.
- The MARIANNE and TH3RESA Phase III
trials underway evaluate trastuzumab emtansine in additional HER2+
mBC patient populations.
- For HER2+ early breast cancer (eBC) –
Roche reported that the data from the Phase II safety trial in the
(neo)adjuvant setting also were submitted to ASCO for presentation.
- Roche has said that it intends to
provide an update on its eBC plans in mid-2012.
Lead wholly owned ImmunoGen product candidates:
- IMGN901 –
In March 2012, began Phase II testing for first-line treatment of
small-cell lung cancer, used in combination with carboplatin and
etoposide (C/E), in the NORTH trial.
- Phase I data for IMGN901 with C/E were
submitted for presentation at a medical meeting taking place in 3Q
2012.
- Compound is also in clinical testing to
treat multiple myeloma.
- IMGN529 –
In April 2012, this CD37-targeting product candidate began Phase I
testing for non-Hodgkin’s lymphoma.
- Two posters on IMGN529 were presented
at the AACR annual meeting in April: one on its safety and activity
in preclinical assessment and one on the CD37 expression diagnostic
developed.
- IMGN853 –
In April 2012, this potential treatment for folate receptor 1
(FOLR1)-expressing solid tumors advanced to having an active
investigational new drug (IND) application.
- Phase I testing is expected to begin in
mid-2012.
- A preclinical poster on IMGN853 also
was presented at AACR.
Other partner compounds:
- SAR3419,
which was created by ImmunoGen and licensed to Sanofi in a broader
collaboration.
- Clinical data with the dose selected
for Phase II testing have been submitted to ASCO for
presentation.
- Three Phase II trials are underway with
SAR3419.
- Six other compounds are in clinical
testing through ImmunoGen collaborations with Amgen, Bayer
HealthCare, Biotest, and Sanofi.
Financial Results and Guidance
ImmunoGen reported a net loss of $18.7 million, or $0.24 per
basic and diluted share, for the quarter ending March 31, 2012 (3Q
FY2012), as compared to a net loss of $15.0 million, or $0.22 per
basic and diluted share, for the same quarter of the last year (3Q
FY2011).
Revenues were $3.3 million for 3Q FY2012, as compared to $5.2
million for the same period last year. Revenues in 3Q FY2012
include $1.3 million of research and development support fees and
$1.0 million of license and milestone fees, compared to $2.2
million and $0.9 million respectively, for the same quarter last
year. Revenues in 3Q FY2012 also include $0.9 million of clinical
material reimbursement, compared to $2.2 million for 3Q FY2011. The
differences in support fees and clinical material reimbursement
from the prior year period are primarily due to the variable nature
in the amount of research and releases of clinical batches done for
partners on a quarter-by-quarter basis.
Operating expenses for 3Q FY2012 were $22.0 million, compared to
$20.3 million in the same period last year. Operating expenses in
3Q FY2012 include research and development expenses of $16.9
million, compared to $15.8 million in 3Q FY2011. Increased
personnel expenses – including increased stock compensation expense
– in support of internal programs and increased clinical trial
costs in the current quarter were partially offset – relative to
the prior year period – by a net reduction in expenses associated
with providing partners with clinical batches. Operating expenses
also include general and administrative expenses of
$5.0 million in 3Q FY2012, compared to $4.6 million in 3Q
FY2011. This increase is primarily due to increased personnel
expenses, particularly stock compensation expense.
ImmunoGen had approximately $175.3 million in cash and cash
equivalents as of March 31, 2012, compared with $191.2 million as
of June 30, 2011, and had no debt outstanding in either period.
Cash used in operations was $18.1 million in the first nine months
of FY2012, inclusive of the $20 million upfront payment from the
collaboration established with Eli Lilly in December 2011. This
compares with $5.9 million of cash provided by operations in the
same period in FY2011, inclusive of the $45 million upfront
payment from the collaboration established with Novartis in October
2010. Capital expenditures were $1.8 million and $1.5 million for
the first nine months of FY2012 and FY2011, respectively.
ImmunoGen’s financial guidance remains unchanged from that
issued in January 2012. ImmunoGen expects its net loss for its
fiscal year ending June 30, 2012 to be between $78 million and $82
million. Net cash used in operations is expected to be between $40
million and $45 million, and cash and marketable securities at its
fiscal year end of June 30, 2012 are expected to total between $145
million and $150 million.
“In addition to our visible progress with IMGN901, IMGN529 and
IMGN853, we also continue to invest in earlier-stage product
candidates and in our technology,” commented Gregory Perry,
Executive Vice President and CFO. “We believe this investment has
the potential to generate the greatest returns for our
shareholders.”
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 913-312-1388. Passcode is 5631072. 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 May 4,
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 numerous TAP compounds in clinical
development with a wealth of clinical data reported. ImmunoGen’s
collaborative partners include Amgen, Bayer HealthCare, Biotest,
Lilly, Novartis, Roche, and Sanofi. The most advanced compound
using ImmunoGen's TAP technology, trastuzumab emtansine, is in
Phase III testing through the Company's collaboration with
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 2012 fiscal year; its cash and marketable
securities as of June 30, 2012; 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, 2011 and other reports filed with the Securities and
Exchange Commission.
-Financials Follow-
IMMUNOGEN, INC. SELECTED FINANCIAL INFORMATION (in
thousands, except per share amounts)
CONDENSED CONSOLIDATED
BALANCE SHEETS (Unaudited) March 31,
June 30, 2012 2011 ASSETS Cash and cash
equivalents $ 175,260 $ 191,206 Other assets 21,068
26,435 Total assets $ 196,328 $ 217,641
LIABILITIES AND SHAREHOLDERS' EQUITY Current
liabilities $ 14,798 $ 14,566 Long-term portion of deferred revenue
and other long-term liabilities 80,600 63,106 Shareholders' equity
100,930 139,969 Total
liabilities and shareholders' equity $ 196,328 $ 217,641
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited) Three Months Ended
Nine Months Ended
March 31, March 31, 2012 2011
2012 2011 Revenues: Research and
development support $ 1,320 $ 2,190 $ 3,333 $ 5,690 License and
milestone fees 999 858 8,211 3,534 Clinical materials reimbursement
933 2,163 1,861
3,576 Total revenues 3,252
5,211 13,405 12,800
Expenses: Research and development 16,933 15,763 49,653
45,192 General and administrative 5,021 4,550
14,696 11,602 Total
operating expenses 21,954 20,313
64,349 56,794 Loss from operations
(18,702 ) (15,102 ) (50,944 ) (43,994 ) Other income, net
33 99 39 1,870
Net loss $ (18,669 ) $ (15,003 ) $ (50,905 ) $
(42,124 )
Net loss per common share, basic and
diluted $ (0.24 ) $ (0.22
) $ (0.66 ) $ (0.62
) Weighted average common shares
outstanding, basic and diluted 76,961
68,067 76,615
67,996
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