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 and fiscal year ended
June 30, 2012 and provided an update on the Company.
“We believe the trastuzumab emtansine clinical data reported at
ASCO convey the transformational potential of our TAP technology,”
commented Daniel Junius, President and CEO. “It is impressive to
see a new product candidate demonstrate both greater efficacy and
better tolerability than standard care, and is noteworthy that
these benefits were seen for a cancer in which considerable
progress already had been made. It also was significant that these
were found in a solid tumor indication – approximately ninety
percent of cancer diagnoses are for solid tumors and very few
antibody-based therapies have been effective for these
cancers.”
Mr. Junius continued, “Roche continues to make important
progress with trastuzumab emtansine, not only advancing it toward
marketing application submission this year, but also broadening the
clinical program to extend into early stage HER2+ breast cancer. At
the same time, we are making visible progress building and
advancing our proprietary product pipeline while other of our
partners also are advancing toward pivotal testing.”
Product Pipeline Update
- Lead compound trastuzumab emtansine, in
development globally by Roche:
- Most advanced indication – Positive
results from Roche’s first trastuzumab emtansine Phase III trial,
EMILIA, were presented at the 2012 American Society of Clinical
Oncology (ASCO) annual meeting in the plenary session. EMILIA
assessed trastuzumab emtansine in patients with HER2+ metastatic
breast cancer (BC) who previously had been treated with Herceptin®
(trastuzumab) and with a taxane. Roche expects to apply in 2012 for
marketing approval of trastuzumab emtansine for this use in the US
and Europe.
- First-line for HER2+ metastatic BC –
Patient enrollment has completed in the Phase III trial, MARIANNE,
evaluating trastuzumab emtansine for this use. Roche expects to use
this trial to apply in 2014 for marketing approval of trastuzumab
emtansine for the first-line treatment of this cancer in the US and
Europe.
- For early stage HER2+ BC – In early
June, Roche outlined its plans to initiate three more trastuzumab
emtansine registration trials in 2013, evaluating the compound for
neoadjuvant use, for adjuvant use and to treat residual invasive
disease following surgery. It anticipates having pathological
complete response (pCR) data from the neoadjuvant trial during
2015.
- IMGN901, ImmunoGen’s lead wholly owned
compound:
- For first-line treatment of small-cell
lung cancer (SCLC) – Patient enrollment is ongoing in the NORTH
Phase II trial, with 28 sites now open. The Company expects to be
able to use this trial to make the decisions necessary to advance
IMGN901 into pivotal testing.Additionally, ImmunoGen expects to
report clinical findings on the IMGN901 dose established for use in
combination with etoposide/carboplatin at the Chicago
Multidisciplinary Symposium in Thoracic Oncology in early
September. The patient population for this Phase I evaluation was
not limited to first-line SCLC.
- For relapsed multiple myeloma – The
Company expects to report findings from the Phase I trial
assessing IMGN901 used in combination with Revlimid®
(lenalidomide)/ dexamethasone at a medical conference in late
2012.
- IMGN853, ImmunoGen’s wholly owned
folate receptor α (FOLR)-targeting TAP compound, began clinical
testing in June 2012. Its Phase I trial is designed to first define
IMGN853’s maximum tolerated dose and dose-limiting toxicity and
then to evaluate it to treat specific types of FOLR-overexpressing
cancers. ImmunoGen expects to be able to use this trial to make the
decisions necessary to advance IMGN853 into pivotal testing.
- IMGN529, ImmunoGen’s wholly owned TAP
compound for the treatment of CD37+ hematologic malignancies,
entered clinical testing in April 2012 for the treatment of
previously treated non-Hodgkin’s lymphoma. The Company expects to
report the first clinical data with IMGN529 in 2013.
- Other clinical-stage compounds – In
addition to trastuzumab emtansine, seven other compounds are in
clinical testing through ImmunoGen’s collaborative partnerships.
- The Company expects up to three of
these compounds to advance into pivotal testing by late 2013.
- SAR3419 – Encouraging Phase I data were
reported with SAR3419 at ASCO. ImmunoGen believes the first Phase
II data with this CD19-targeting TAP compound could be presented at
a medical meeting in late 2012.
Fiscal Year 2012 Financial Results
For the Company’s fiscal year ended June 30, 2012 (FY2012),
ImmunoGen reported a net loss of $73.3 million, or $0.95 per basic
and diluted share, compared to a net loss of $58.3 million, or
$0.85 per basic and diluted share, for its fiscal year ended June
30, 2011 (FY2011). For the quarter ending June 30, 2012, ImmunoGen
reported a net loss of $22.4 million, or $0.29 per basic and
diluted share, compared to a net loss of $16.2 million, or $0.23
per basic and diluted share, for the same quarter in FY2011.
Revenues in FY2012 were $16.4 million, compared to
$19.3 million in FY2011. Revenues in FY2012 include $9.2
million of license and milestone fees compared to $6.4 million
in FY2011. The FY2012 fees include $5.0 million in milestone
payments earned with partner advancement of one TAP compound into
Phase II clinical testing and two TAP compounds to Phase I clinical
testing. The FY2011 fees include $3.0 million in milestone payments
earned with partner advancement of two TAP compounds to Phase I
clinical testing. Revenues in FY2012 also include $4.5 million of
research and development support fees and $2.7 million of clinical
materials revenue, compared to $7.3 million and $5.7 million,
respectively, for FY2011. The differences in support fees and
clinical material revenue from the prior year are primarily due to
the variable nature in the amount of research and in the number of
clinical batches produced and released for partners on a
year-to-year basis.
Operating expenses in FY2012 were $89.6 million, compared
to $79.5 million in FY2011. Operating expenses in FY2012 include
research and development expenses of $69.2 million, compared to
$63.5 million in FY2011. This increase is primarily due to
greater investment by the Company in aggressively advancing its
wholly owned product candidates. It includes increased personnel
expenses – including increased stock compensation expense – in
support of internal programs, partially offset by a net reduction
in expenses associated with providing partners with clinical
batches. Operating expenses also include general and administrative
expenses of $20.4 million in FY2012, compared to $16.0 million
in FY2011. This increase is primarily due to increased personnel
expenses, particularly stock compensation expense.
Other (expense) income, net, was $(62,000) in FY2012, compared
to $1.9 million in FY2011. Other income in FY2011 included
$1.2 million of federal grant funding the Company was awarded
under the Patient Protection and Affordable Care Act of 2010 to
develop new anticancer therapies and $0.3 million of gains
recognized on sales of investments.
Cash used in operations was $34.3 million in FY2012,
inclusive of the $20 million upfront payment from the collaboration
established with Eli Lilly in the second quarter of FY2012. This
compares with $8.0 million of cash used in operations in FY2011,
inclusive of the $45 million upfront payment from the collaboration
established with Novartis in the second quarter of FY2011. Capital
expenditures were $2.9 million and $2.0 million for FY2012 and
FY2011, respectively.
ImmunoGen had approximately $160.9 million in cash and cash
equivalents as of June 30, 2012, compared with $191.2 million as of
June 30, 2011 and had no debt outstanding in either period.
Not included in the June 30, 2012 cash and cash equivalents are the
approximately $94 million in net proceeds from the Company’s recent
public stock offering.
Financial Guidance for FY 2013
ImmunoGen expects its net loss for its fiscal year ending June
30, 2013 to be between $70 million to $74 million, its
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 marketable securities at June 30, 2013 are
anticipated to be between $172 million to $176 million, inclusive
of the net proceeds from the public stock offering recently
completed.
“Roche, Sanofi and the rest of our partners are making tangible
progress with compounds that can generate meaningful revenue to
ImmunoGen,” commented Gregory Perry, Executive Vice President and
CFO. “Our strong financial position enables us to aggressively fund
advancement of our wholly owned compounds to further enhance
shareholder value.”
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 913-312-1510. Passcode is 6959547. 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 August 17,
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.
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.Revlimid® is a
registered trademark of Celgene Corporation.
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, 2011 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) June 30, June 30,
2012 2011 ASSETS Cash and cash equivalents $
160,938 $ 191,206 Other assets 19,370 26,435
Total assets $ 180,308 $ 217,641
LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities $
16,254 $ 14,566 Long-term portion of deferred revenue and other
long-term liabilities 80,164 63,106 Shareholders' equity
83,890 139,969 Total liabilities and
shareholders' equity $ 180,308 $ 217,641
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited) Three Months Ended
Fiscal Year Ended June 30, June 30,
2012 2011
2012 2011
Revenues: Research and development support $ 1,184 $ 1,566 $ 4,517
$ 7,256 License and milestone fees 950 2,859 9,161 6,393 Clinical
materials revenue 818 2,080
2,679 5,656 Total revenues
2,952 6,505 16,357
19,305 Expenses: Research and development 19,539
18,261 69,192 63,453 General and administrative 5,726
4,438 20,422 16,040
Total operating expenses 25,265 22,699
89,614 79,493 Loss from
operations (22,313 ) (16,194 ) (73,257 ) (60,188 ) Other
(expense) income, net (101 ) 44 (62 )
1,914 Net loss $ (22,414 ) $ (16,150 ) $
(73,319 ) $ (58,274 )
Net loss per common share, basic
and diluted $ (0.29 ) $
(0.23 ) $ (0.95 ) $
(0.85 ) Weighted average common
shares outstanding, basic and diluted 77,416
71,315 76,814
68,919
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