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
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